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What’s Next for Medical Writing? Top Trends Shaping the Industry

Our recent poll revealed that Artificial intelligence (AI) integration is anticipated to have the most significant impact on the future of medical writing. With a rapidly evolving healthcare industry, medical writers are expected to adapt to a dynamic environment shaped by technological advancements, patient-centered approaches, and globalization. This article delves into the trends that will shape medical writing in the coming years and what they mean for professionals in the field.

  1. AI Integration: Shaping the Future of Medical Writing

The poll results indicate that a significant 60% of respondents believe AI integration will play a pivotal role in medical writing. This trend is expected given the growing impact AI is already having on the field. From automating literature searches to drafting clinical study reports, AI is improving efficiency, accuracy, and productivity.

Key Contributions of AI to Medical Writing

  • Automated Content Generation: AI-powered tools like ChatGPT can draft sections of manuscripts, abstracts, and summaries. This reduces the time required for first drafts, enabling writers to focus on refining content and ensuring compliance with regulatory standards.
  • Data Analysis and Interpretation: Tools equipped with natural language processing (NLP) can extract and analyze data from clinical trials, research papers, and regulatory documents. AI simplifies complex data sets, helping writers present findings clearly and concisely.
  • Grammar Check and Translation: AI tools are increasingly being used for grammar and style checks, ensuring documents adhere to linguistic and stylistic standards. Additionally, advanced translation technologies enable seamless multilingual content creation, breaking language barriers, and facilitating global communication.

AI’s role in medical writing extends beyond automation. It enables predictive analytics and personalized content creation, offering tailored solutions for diverse audiences, including healthcare professionals, regulatory bodies, and patients.

Challenges and Opportunities

While AI offers immense benefits, it also raises concerns about data security, ethical considerations, and the potential loss of human oversight in sensitive medical communications. However, these challenges present opportunities for medical writers to upskill and collaborate with AI, enhancing their roles as content strategists and quality controllers.

  1. Evidence-based Writing: The Foundation of Credible Communication

Coming in as the second most influential trend, with 19% of the votes, evidence-based writing underscores the importance of accuracy and scientific rigor in medical communication. As healthcare decisions increasingly rely on data-driven insights, medical writers must ensure their content is rooted in robust evidence.

The Role of Evidence-based Writing

Transparency and Accountability: Evidence-based writing involves citing credible sources, ensuring transparency, and providing a clear trail of evidence supporting medical claims. This is crucial in regulatory documents, clinical trial reports, and healthcare guidelines.

Strengthening Healthcare Decisions: By presenting data from systematic reviews, meta-analyses, and clinical trials, medical writers help healthcare professionals make informed decisions. This approach supports the development of effective treatments and interventions.

Adapting to New Data Standards

The demand for evidence-based writing is expected to grow as data-sharing initiatives and open-access publishing increase. Medical writers must stay updated on evolving guidelines and best practices for integrating and presenting evidence in various formats.

  1. Patient Centricity: Putting Patients at the Center of Communication

With 17% of respondents highlighting patient-centricity as a key trend, it’s clear that the focus on patients is becoming more central in medical writing. This shift reflects a broader movement in healthcare toward empowering patients and ensuring they are active participants in their care journey.

What is Patient-centric Medical Writing?

Patient-centric medical writing involves tailoring content to meet the needs of patients, ensuring information is accessible, understandable, and relevant. This includes:

  • Simplifying Medical Jargon: Translating complex medical terminology into lay language, so patients can understand their diagnoses, treatments, and clinical trial participation.
  • Focusing on Patient Experiences: Including patient-reported outcomes and experiences in clinical trial reports and other medical documents.
  • Developing Patient Education Materials: Creating leaflets, brochures, and digital content that inform and empower patients.

The Rise of Plain Language Summaries (PLSs)

One of the most notable developments in patient-centric medical writing is the increasing use of PLS. These summaries provide a clear and concise overview of complex medical research, making it accessible to non-specialist audiences. As regulatory bodies like the European Medicines Agency (EMA) emphasize the importance of PLS, medical writers are expected to play a pivotal role in their development.

  1. Multilingual Content: Breaking Language Barriers

Though only 4% of respondents identified multilingual content as a top trend, its importance cannot be overstated. As healthcare becomes more globalized, the ability to communicate effectively across different languages and cultures is critical.

Why Multilingual Content Matters

  • Global Clinical Trials: With clinical trials conducted across multiple countries, medical writers must produce documents that cater to diverse regulatory requirements and linguistic needs.
  • Health Campaigns and Education: Multilingual content ensures that vital health information reaches diverse populations, promoting inclusivity and equity in healthcare.
  • Regulatory Submissions: In regions like the European Union, regulatory submissions often require documentation in multiple languages.

Tools and Techniques for Multilingual Medical Writing

Advancements in translation technologies, including AI-driven tools, are making multilingual medical writing more efficient. However, human oversight remains crucial to ensure cultural nuances and context are accurately conveyed.

How AI Can Support Every Trend

AI plays a pivotal role in each of these emerging trends. In evidence-based writing, AI tools can swiftly analyze vast amounts of clinical data, enabling writers to identify and cite the most relevant evidence. For patient-centricity, AI can personalize content by analyzing patient feedback and tailoring educational materials to specific needs. In the realm of multilingual content, AI-driven translation tools ensure timely and accurate communication across languages, fostering inclusivity. AI is not only a driving force in its dedicated trend but also a supportive tool that enhances the effectiveness of every other emerging aspect of medical writing.

Implications for Medical Writers

The trends identified in our poll reflect a dynamic and rapidly evolving field. To stay ahead, medical writers must adapt and expand their skill sets:

  • Technical Proficiency: Familiarity with AI tools and data analysis software will be essential as automation becomes more prevalent.
  • Continuous Learning: Keeping up-to-date with evolving guidelines, best practices, and new trends like patient-centric and evidence-based writing.
  • Cultural Competence: Understanding and respecting cultural differences will enhance the effectiveness of multilingual content.
  • Interdisciplinary Collaboration: Working closely with healthcare professionals, regulatory bodies, and patient advocacy groups to create impactful medical communications.

The Road Ahead

As we look to the future, it’s clear that medical writing will play an even more critical role in shaping healthcare communication. The integration of AI, the emphasis on evidence-based and patient-centric approaches, and the need for multilingual content will redefine the profession, offering both challenges and opportunities.

At Turacoz, we are committed to embracing these trends and equipping our team with the skills and tools to lead in this evolving field. Whether it’s leveraging AI for efficiency, adopting evidence-based methodologies, or focusing on patient-first communication, we are ready to meet the challenges of the future head-on.

For more information, reach out to us at [email protected]

Role of a Medical Writer in Publication Documents

Background

Writing is a medium of human communication to express one’s thinking in easily understandable but effective way. The strength of writing is displayed by its knowledge-transforming effects. Knowledge is vital at every stage of research-based endeavours in basic research, clinical research, drug development lifecycle, drug approvals, phases of clinical trials, and post-marketing research.  At each stage, this knowledge is passed on in writing to communicate the findings of research to the scientific community, clinicians, regulators as well as public.

Importance of publication

Publishing biomedical research, in the form of case reports, original articles, literature reviews etc. in peer-reviewed journals, is important. Doing so, augments understanding of health, diseases and their management, drug risks and benefits, and helps to improve medical practice benefitting the patients, health community and society at large.

Reasons to not publish

However, despite the fact that most clinicians and researchers understand the need to publish their work, this task may prove challenging to them because of various reasons including lack of time to write and submit, inadequate data analysis support and technical writing expertise, and lack of knowledge of publication practices and guidelines (1).  But, we all understand and admit that scientific information can be difficult to read and to comprehend. A poorly written information could easily confuse the reader and leave the audience misinformed. For these reasons, numerous papers are rejected by top peer-reviewed journals.

Medical Writing services

Medical writing is communication of scientific and clinical information in a clear, accurate, unbiased, and logical way to a specific set of target audiences such as clinicians, healthcare professionals, regulators, scientists, patients, and general public. This includes the preparation of different types of documents: Regulatory (e.g. clinical trial protocols, clinical study reports, investigator’s brochures, new drug applications, research proposals, informed consent documents); Publications (e.g. original articles, literature reviews, case reports, editorials, abstracts for conferences); Medical education (e.g. posters, continuing medical education (CME), e-learning modules, slide decks for meetings, brochures and internet content for physicians and patients); and Medico-marketing (e.g. literature for product promotion) (5).

Medical Writing – need and demand

There’s pressing need for effective presentation and dissemination of knowledge to accelerate publishing and decision-making in healthcare. Supporting this, a Portuguese report highlighted the importance of medical writing skills for successful publishing in top-rated journals (2). Furthermore, according to a report, global demand for medical writing market was valued at approximately USD 2.03 billion in 2018 and is expected to generate a revenue of around USD 2.95 billion by the end of 2025 (3). Even in India, the medical writing industry is on an upward growth path (4).

Medical Writer – skills and role in publication

Researchers and clinicians may be best at their jobs, but they may not necessarily have the skills to present their data in an effective manner. A medical writer (MW) is a scientific writing and editing expert with an advanced degree in biomedical sciences (e.g. MBBS, PhD) and robust understanding of biomedical and clinical research, reporting guidelines and publication practices such as ICH, ICJME, GPPs, CONSORT (6). He/she would possess substantial data analysis skills to be able to summarise and present even the most complex clinical research data in a coherent manner. This helps the researchers to achieve objectives such as getting their work published in a respected journal, receiving funding for research projects or finding acceptance of their work by their professional peers.

Therefore, the documents prepared with the support of medical writers are less likely to get rejected or retracted by the peer-reviewed journals as they adhere to the reporting and publication guidelines specified by the journals. Such documents are accepted for publication quickly as good writing fastens the review process as compared to the ones without any such support (7). All this suggests that a MW makes a substantial contribution towards a good quality research publication. In addition to providing writing assistance, a MW advise on the right journals for an article and offer support for editing, journal styling and submitting the manuscript for publication (Figure 1).

A MW has the ability to model his/her writing in terms of most suitable language and level of technical information depending on the target audience. For instance, the documents entitled for medical professionals usually include detailed clinical information or data while the ones intended for common people are in simple language and free of core scientific details. In regulatory writing, a MW is well aware of the prescribed formats and regulatory guidelines to be strictly followed in order to produce the high-quality documents.

MWs are not involved in the conception, design or execution of clinical research, so they are not listed as authors, but their contributions are mentioned in the acknowledgments section of the manuscript (8).

Conclusion

Clear, logical, and accurate writing reinforces the dissemination of reliable research information through good quality publications to varied target audience. MWs play an important role to speed up the publication process to meet the growing need for high-quality, timely publications. Clear understanding of the role of a medical writer in publication development will pave the way for their appropriate use by clinicians and scientists to communicate their research findings to the scientific community.

The Medical Writers at Turacoz Healthcare Solutions (THS) understand and abide by the reporting guidelines and publication practices such as ICH, ICJME, GPPs, CONSORT to deliver high-quality documents communicating scientific and clinical information. Turacoz is a medical communications company, which offers services to healthcare professionals in clinical research, regulatory writing, publication writing, medico-marketing writing, and support for conducting medical advisory board meetings.

If you have any queries, email us at [email protected].

References

  1. Sharma S. Professional medical writing support: The need of the day. Perspectives in clinical research 2018; 9:111-112.
  2. Marinho RT, Donato H, Fernandez-Llimos F, Massano J, Silva JM, Almeida M, et al. Think Tank: Relatório estratégico sobre publicação científica biomédica em Portugal. Acta Med Port. 2014;27:1-3.
  3. Global Industry Perspective, Comprehensive Analysis and Forecast, 2019 – 2025. Available from: https://www.zionmarketresearch.com/report/medical-writing-market. Accessed on 15 July 2020.
  4. Shirke S. Medical writing on an accelerated path in India. Perspect Clin Res. 2015;6:125-128.
  5. Bissau J, Borrego P. Professional medical writing: A tool for high quality publications. Acta Med Port. 2015;28:545–7.
  6. Das N, Das S. Hiring a professional medical writer: is it equivalent to ghostwriting? Biochem Med. 2014;24:19-24.
  7. Wager E, Woolley K, Adshead V, Cairns A, Fullam J, Gonzalez J, et al. Awareness and enforcement of guidelines for publishing industry-sponsored medical research among publication professionals: the Global Publication Survey. BMJ Open. 2014;4:e004780.
  8. Angela Stocks, Donna Simcoe, Dikran Toroser & Lisa DeTora. Substantial contribution and accountability: best authorship practices for medical writers in biomedical publications. Current Medical Research and Opinion 2018;34:1163-1168.

Working from home in pandemic: How yoga can be your best friend in this time?

It has been weeks and months since we have stopped counting days being in this pandemic-driven lockdown. There is a unique quality to this day-by-day pandemic despair; this quarantine depression is edging humans into physical and mental stagnation.  According to an article I read in the Hindu couple of days back, approximately  12.2 crore Indians lost their jobs during the coronavirus lockdown in April 2020 only, which makes COVID 19 pandemic much more stressful for people.

Not only for people who have lost their jobs, but also for people who are working from home in this pandemic and trying to juggle between their family and work without any house help and childcare services available, that this pandemic is proving more emotionally exhausting than the virus itself. With an official Microsoft TEAMS video call in my morning joggers or stirring the ladle in a cooking pot with my official call in my earpods and with my toddler in my arms, I too am acing at juggling! Watching this situation very closely for past couple of months now, I feel a more accepting and holistic approach to this fiasco is the need of the hour.

We all know that there is uncertainty & fear and we all are multitasking around for the past 4-5 months, but instead of getting bogged down, coping with stress in a healthy way will not only make us, but the people we care about and our community stronger. The best we can do is accept the situation and take care of our and our family’s mental and physical health. One way that I discovered and loved during this period, is a 40 minutes yoga routine with 10 minutes meditation, to reinforce my strength and potential. Every single day for past three months now: believe me these are the most blissful 60 minutes I have from my day! I feel that my mind is calmer and more focussed; I am able to do one thing at a time, that too perfectly and my productivity has increased like anything. I am following a very good book ‘Light on Yoga’ by BKS Iyengar and practicing yoga from the same.

It can be anything, as long as you are present in the moment mentally & physically and moving, stretching and doing basic pranayama initially for 10 minutes in a day and gradually increasing to half an hour or 40 minutes; but please follow the same with 10 minutes of mediation (just focussing on your breath with closed eyes) and you will feel a positive change in your day. You can even take breaks in between your office calls and stretch your arms, necks or legs for 2 minutes on the chair or your yoga mat.

On the occasion of International Yoga Day 2020, I am sharing some of basic yoga poses which I have been practicing and you can also start with them as a beginner in yoga journey:

Trianga Mukha Eka Pada Paschimottanasana: Keeping one knee folded, try to touch your nose to the other stretched knee. It gives a nice and long stretch to your tense back and can make you ready for a long office call.

Matasyasana: Matasyasana or  Fish pose is a reclining back-bending pose. It relieves tension in your neck, throat, and shoulders and stretches and tones the front of your neck and your abdominals. It could be proven beneficial for all the creative people who like to keep their neck in the laptop screens for better focus.

Dhanurasana: Dhanurasana or chakrasana or wheel pose or The Upper Facing Bow whatever you can call, it can help—and strengthen your arms, legs, abdomen, and spine. For this one, you bend your knees and place your heels as close to the hips as possible and then slowly raise your arms, bend your elbows by resting the palms beside your ears.Floating camel pose: an advance version of Utraasna. This one is little bit of an advance yoga pose and maybe you will be able to do it after a month’s practice but the benefits are for sure worth the pain in the process. It increases flexibility in the spine, stimulates the nervous system, opens the chest and shoulders, improves circulation and digestion, and stimulates the thyroid gland. It’s said to rejuvenate/increase energy levels, and lower blood pressure.Sirsasana or headstand: and finally the king of all the yoga poses, The headstand. This is definitely a very advance yoga pose but is known as the most relaxing and cooling posture. It helps you to draw your attention inwards, to concentrate more, to focus more. This posture is extremely helpful if you are having anxiety, stress, fear or otherwise worrisome thoughts. Combine headstand with long, slow breathing and you have a recipe for stress relief.

So happy International yoga day 2020 people and I would like to leave you with a very special quote from my favourite yogi BKS Iyengar, ‘Yoga is a light, which once lit, will never dim. The better your practice, the brighter the flame.’

Good Practices for Conference Abstracts and Presentation

Medicine is an ever-changing science. As new researches and clinical experience broaden our knowledge, changes in treatment, and drug therapy help in improvising patient care management. WHO describes research as being an imperative element for settling public health challenges – whether it be combating the diseases highly prevalent in developing countries, responding to the alarming rise of chronic conditions, or ensuring proper prenatal, natal and post-natal care for women and children. Research is a structured evaluation to present the facts and reach new conclusions. Medical and scientific conferences serve as a platform for research sponsored by various organizations. These conferences are of crucial importance to disclose and discuss potentially practice-changing data of on-going research studies. The variation in the practices of different organizations makes it difficult to adhere to the good publication practice guidelines and conference requirements. There are no specific guidelines or recommendations to describe the standards for conference presentations.

Company-Sponsored Research

The company-sponsored research is presented in the conferences in the form of abstracts and posters. The scientific committee of the conference review the abstracts. However, they are not included in the peer-review process, as are the journal articles. Further, reviewing the poster and oral presentations is rare. A systematic review reported < 50% were published in full, following presentation at a conference after being accepted as abstracts. It is of utmost importance to attain a high standard process for developing conference abstracts and presentations, mainly for company-sponsored research, since it may ultimately become the only source for a particular analysis. The Good Publication Practices (GPP), Consolidated Standards of Reporting Trials (CONSORT), and Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and recommendations are followed for the conference presentations. On the other hand, the International Committee of Medical Journal Editors (ICMJE), the most widely cited recommendations on authorship, is related exclusively to the publications in peer-reviewed journals. It is challenging to implement these guidelines in practice since they are not fully applicable to conference presentations.

Principles of Good Publication Practice for Company-Sponsored Medical Research

As per GPP guidelines, Good practice for conference abstract and presentation focuses on the presentation of all company-sponsored researches. GPCAP aims to provide guidance on good submission and presentation practice for scientific and medical congresses, explicitly addressing certain aspects where current publication guidelines are inadequate.

Some of the principles for practicing good publication are as follows

  • Ensure timely submissions of the study report guaranteeing complete transparency and accuracy.
  • Reporting and publication processes should follow the FDA, ICMJE, and EQUATOR guidelines.
  • Ethical guidelines should be followed to deliver originality in the abstract and avoiding redundancy.
  • The authorship, contributors (including the writing support), and the sponsorship should be mentioned clearly, ideally at the start of the research, and, in all cases, before publication preparation begins.
  • All the authors should have access to study data and other information; all named authors should review, approve the content of abstracts and presentations, and should take responsibility while being involved in the process of publication.
  • All authors and contributors should disclose any relationships or potential competing interests relating to the research and its publication or presentation.
  • The registration number of the study should be mentioned.

Recommendations for conference organizers

Conference organizers should:

  • Encourage and support the inclusion of contributor lists on posters and slides
  • Include the space for the trial registration number, medical writing support disclosure, sponsor details on abstract forms
  • Use Open Researcher and Contributor ID (ORCID) to uniquely identify scientific and other academic authors and contributors.

Encore Abstract

An encore abstract is typically defined as presenting the same study reports at different conferences to reach various audiences. Even though encore abstracts are not considered to be a superfluous presentation, some conferences accept only the additional findings that were not presented in any other scientific meetings. Presenting the same study to different conferences, the authors and the company sponsoring the research should consider submitting different parts of the studies to reach different audiences at various conferences. It should be noted, the addition of new data to a previously accepted abstract may not necessarily constitute a new abstract unless it is confirmed with the conference.

Encore Checklist

  • Ensure there is no overlapping in terms of the region, profession, etc.
  • Make sure there is no licensing difference between the two regions for the product/medicine of the study.
  • Ensure timely publication of the study even with multiple presentations.

Conclusion

Good publication practices are essential elements and the growing need for on-going and evolving researches in the field of medicine. The authorities and the committees around the world have put together the recommendations and guidelines for improving the accuracy and originality of the study presentations while decreasing the incidence of unethical writing practices; thus, preserving the authenticity of the study. Hence, following appropriate recommendations and guidelines can be helpful in putting forward the research in an effective manner.

Turacoz Healthcare Solutions aims at encouraging the researchers and the medical writers in following Good Publication Practices.

If you wish to contact us, click here.

Email us at : [email protected]

[email protected]

Blood Donation: Significance

The gift of blood is the gift of life. There is no other substitute for human blood. According to statistics, every two seconds someone is in dire need for blood. And only one pint of blood can save up to three lives. Data collected over a span of many years suggests that the blood type most often requested by hospitals is Type O.

Sickle cell patients are required to have frequent blood transfusions throughout their lives. And for cancer patients (with an estimate of more than 1 million new patients every year), many of them require blood, sometimes on a regular basis, during their chemotherapy treatment.

FYI: A single car accident victim can require up to 100 units of blood to survive.

Things to know about the blood donation process:

  • Blood donation is safe! Hospitals/doctors/nurses make sure that a sterile needle is used only once for each individual donor and then discarded/destroyed.
  • The process is simple. Mainly consisting of four steps:
  1. Registration
  2. Physical & Medical history
  3. Donation
  4. Refreshments
  • A mini-physical is done for every donor, checking his/her temperature, blood pressure, pulse and hemoglobin count. Basically, to ensure that the donor is fit for donating, and if whether it is safe.
  • The real process takes around 10-12 minutes. It is crucial for you to stay calm if it is your first time donating.
  • The average human adult has approximately 10 units of blood in their body. At the time of donation, roughly one unit is given (don’t worry you still have enough).
  • Red blood cells can be donated every 56 days (by a healthy person).
  • Platelets can be donated every 7 days apart (a maximum of 24 times a year).
  • All blood donations are tested for HIV/AIDS, hepatitis B & C, syphilis and other diseases, before it is transfused.

General FYI:

  • Type O- red cells can be transfused to patients of all blood types.
  • Type AB+ plasma can be transfused to patients of all other blood types.

Top Ten Reasons Why You Should Donate Blood (there is no denying these):

  1. First of all, it saves lives! What else is there to know?
  2. It is one of your civic duties as a responsible citizen.
  3. Not everyone can donate blood, it’s a blessing to have the ability to save people.
  4. If one day you need blood, you won’t hesitate to take it, so why hesitate to give it?
  5. It gives the donors a free medical checkup.
  6. It helps maintain an adequate blood supply in the community for secure blood transfusions.
  7. The feeling of satisfaction of helping others is unreal.
  8. Even though the cure for cancer is not discovered, yet! But donating blood helps keep someone alive while they wait for the cure.
  9. The real question is, why not give blood?
  10. Excuses are always vague, there is no logical reason as to why a healthy person should not donate blood.

Advantages of donating blood:

Donating blood is not only beneficial for the person receiving it, but it is also highly beneficial for the donor’s health.

  • Lowers iron levels: The body needs iron to produce red blood cells. But too much iron in the blood can be harmful. Too much iron in one’s blood can lead to it being deposited in different organs of the body, such as the heart and the liver, and this could lead to a malfunction in the way those organs function. Donating blood can help control the level of iron in your system.
  • Checks your system: Each and every person who donates blood undergoes a simple physical examination and a blood test before they can move on to donating their blood. Through these tests, hospitals can assess a person’s internal fitness and health. It is highly possible that a person could identify unknown health issues as a part of the blood donation process. The donor is tested for HIV/AIDS, hepatitis B & C, and/or any other blood-borne diseases.
  • Burns calories: According to the University of California, San Diego, donating blood has been proven to burn around 650 calories per donation. Its like getting ripped without going to gym. But on a more serious note, donating blood cannot be considered as an alternative to exercise. Also, after donating blood try to hold off on going to the gym the very same day, take some rest.

Disadvantages of donating blood:

  • Dizziness
  • Feeling faint
  • Lightheadedness
  • Nausea

Note: These symptoms usually subside within 3 days of donating blood.

Turacoz Healthcare Solutions aims to spread awareness about the benefits and advantages of donating blood. We urge the people to take part in this noble act of saving lives. We wish that people would actively contribute in this ‘gift of life’ and are working hard towards achieving a healthier future for the masses.

If you wish to contact us, click here.

How to Prevent HIV/AIDS?

The world’s leading public health challenge is the HIV virus that leads to AIDS. In 2018, around 37.9 million people were infected with HIV/AIDS and approximately 1.7 million more joined the club worldwide. Only 79% of the affected numbers were aware of their HIV status and the remaining 21% did not even have access to HIV testing services. The death rate associated with AIDS has reduced from 1.7 million in 2004 to 770,000 in 2018 [1,2,3].

A brief summary on the HIV epidemic is presented in the Figure 1 [2]

Figure 1: Global HIV Epidemic [2]

Despite the advances in our healthcare sector and availability of a wide range of effective prevention tools, a large number of individuals with HIV or at risk of HIV do not have access to the prevention, care, and treatment [1]. A study reported that majority of the current HIV transmission is done via people who inject drugs, occurring in the majority of low and middle-income countries [4].

The advances in science have provided many tools to prevent HIV these days. However, to protect oneself from a disease one should be aware about the cause of the disease, with an understanding of how the virus spreads. HIV virus can be passed in the following ways [5]:

  • Having sexual intercourse with an HIV infected person
  • By sharing contaminated needles such as through blood transfusion or drug use
  • From an HIV infected mother to the foetus during pregnancy, or through breast feeding

Anyone and everyone is vulnerable to the HIV virus, but preventive measures can help one to reduce the risk of getting infected. Key approaches for the prevention of HIV are listed below:

HIV Prevention Medication [6,7]

Pre-exposure prophylaxis (prEP) and post-exposure prophylaxis (PEP) can greatly reduce the risk of contracting the HIV infection. According to the federal guidelines, prEP is considered for HIV-negative or people at a very high risk of HIV. It consists of daily medication and regular visits to a healthcare professional. This includes:

  1. Anyone who is in sexual contact with a HIV positive person
  2. A man who has sex with both women and men
  3. A heterosexual man or woman who have had sexual intercourse with partners of unknown HIV status.

PEP can prevent you from becoming infected with the virus once you are exposed to it. For this medication to work, it must be started within 72 hours after a possible exposure. It should be taken once or twice daily for 28 days. Use of condoms and safe injection practices is recommended during the medication.

An HIV-negative person has the following ways to protect himself/herself from getting infected:

Figure 2: Steps of Prevention for HIV-negative person

Treatment as Prevention [7]

This refers to the use of HIV medication to prevent transmission of the infection to others. An HIV infected person taking the medications as prescribed and has regular follow-ups to keep an undetectable viral load are at no risk of transmitting HIV to their HIV-negative partners. Antiretroviral therapy (ART) to suppress the virus should be taken regularly as it prevents the virus from growing in our body that keeps us healthy and prevents illness. Women infected with the virus are recommended to take the treatment to minimize the risk of transmission to the foetus during pregnancy or delivery. After conception, the new-born receives HIV medications for 4 to 6 weeks. Figure 2 shows the actions to be taken to prevent HIV from passing to others.

Figure 3: Steps for Prevention for HIV-positive person

The United Nations organized the Joint United Nations Programme on HIV/AIDS (UNAIDS) with an ambitious target to treat HIV with a 90-90-90 goal. By 2020, 90% of the people living with HIV will be aware of their HIV Status. 90% of the people diagnosed with HIV will receive a proper antiretroviral therapy (ART). 90% of people on ART will have viral suppression [1,7].

Turacoz Healthcare Solutions aims to spread awareness about HIV/AIDS. We urge the people to be aware about the condition. Following the preventive measures and seeking counseling is the best way to avoid this condition. However, for the HIV infected individuals it is best to continue with the ART and maintain a healthy diet. Nevertheless, with love and support from family and friends they can lead a happy and long life.

If you wish to contact us, click here.

References

  1. Retrieved from: https://www.hiv.gov/hiv-basics/overview/data-and-trends/global-statistics [Accessed on 26th December 2019]
  2. Retrieved from: https://www.who.int/hiv/data/en/ [Accessed on 26th December 2019]
  3. Retrieved from: https://www.unaids.org/en [Accessed on 26th December 2019]
  4. Mathers BM, Degenhardt L, Phillips B, Wiessing L, Hickman M, Strathdee SA, Wodak A, Panda S, Tyndall M, Toufik A, Mattick RP. Global epidemiology of injecting drug use and HIV among people who inject drugs: a systematic review. The Lancet. 2008 Nov 15;372(9651):1733-45
  5. Retrieved from: https://stanfordhealthcare.org/medical-conditions/sexual-and-reproductive-health/hiv-aids/treatments/prevention.html [Accessed on 26th December 2019]
  6. Retrieved from: https://www.cdc.gov/hiv/basics/prevention.html [Accessed on 27th December 2019]
  7. Retrieved from: https://www.hiv.gov/hiv-basics/hiv-prevention/reducing-sexual-risk/preventing-sexual-transmission-of-hiv [Accessed on 27th December 2019]
  8. Retrieved from: https://www.unaids.org/en/resources/909090 [Accessed on 26th December 2019]
  9. Retrieved from: https://www.hiv.gov/hiv-basics/hiv-prevention/using-hiv-medication-to-reduce-risk/hiv-treatment-as-prevention [Accessed on 27th December 2019]

HIV Awareness

The human immunodeficiency virus (HIV) invades the immune system and damages the host’s defense system and causes it to weaken against all kinds of minor and significant infections and cancers. Thus, gradually leading to immunodeficiency, which in turn makes the body susceptible to opportunistic infections. CD4 cell count typically measures immune function. As stated by global statistics about 37.9 million people were HIV infected in 2018, with a prevalence of 0.8% in adults.

The advancement to a stage of acquired immunodeficiency syndrome (AIDS), takes 2 to 15 years to occur if not treated, depending on the individual.

Signs and symptoms

The symptoms of HIV depend on the stage of infection. It’s noteworthy that people with HIV infection are highly contagious during the initial period. However, most individuals aren’t aware of this until the later stages. People may experience no symptoms or influenza-like illnesses, including headache, rash, fever, and sore throat. The progressing illness leads to advanced symptoms and signs, like diarrhea, fever, cough, without treatment; tuberculosis (TB), cryptococcal meningitis, severe bacterial infections, swollen lymph nodes, weight loss, and cancers such as lymphomas and Kaposi’s sarcoma.

Transmission

Transmission of this dreadful disease occurs through the exchange of a variety of bodily fluids such as blood, breast milk, semen, and vaginal secretions from infected people, and from a mother to her child during pregnancy and delivery. Individuals cannot become infected through regular day-to-day contacts such as kissing, hugging, shaking hands, or sharing personal objects, food, or water.

Risk factors

Behaviors and conditions that put individuals at higher risk of contracting HIV include:

  • Unprotected anal or vaginal sex
  • Drug abuse
  • Sexually transmitted infections (STI) like syphilis, gonorrhea, bacterial vaginosis, herpes, and chlamydia
  • Use of contaminated needles, syringes, and other injecting equipment and drug solutions when injecting drugs
  • Unsafe blood transfusions, injections, using contaminated and unsterilized needles, and tissue transplantation
  • Experiencing accidental needle stick injuries, including among health workers

Diagnosis

HIV diagnosis is made through rapid diagnostic tests that provide same-day results. These tests dramatically facilitate early diagnosis and treatment. There are self-diagnostic tests available to help test for HIV infection; however, a confirmatory test is always required, conducted by a qualified and validated health worker at a community center or clinic. The WHO pre-qualified tests are the most accurate for diagnosing HIV infection. These tests detect the antibodies produced from the infected individual. People develop antibodies within 28 days of infection. This period is called window period, during which a person does not experience any symptoms; however, he/she might transmit the disease to others.

All the HIV positive patients should be retested before enrolling for the prescribed treatment, to rule out any testing or reporting error.

While testing for babies born to HIV-positive mothers, the virology test is the test of choice and should be performed at birth or 6 weeks of age. New technologies are being available to help perform these tests more accurately along with delivering the results on same day.

HIV testing services

HIV testing should be voluntary and the right to decline testing should be recognized. Mandatory or coerced testing by a health care provider or authority, or by a partner or family member is not acceptable as it undermines good public health practice and infringes on human rights.

All HIV testing services must follow the WHO-recommended principles known as the “5 Cs”:

  • Informed consent
  • Confidentiality
  • Counseling
  • Correct test results

Connection (linkage to care, treatment and other services)

Prevention

Individuals can reduce the risk of HIV infection by limiting exposure to risk factors. Key approaches for HIV prevention, which are often used in combination, are listed below.

  • Male and female condom use
  • Testing and counseling for HIV and STIs
  • Testing for HIV and other STIs
  • Testing and counseling, linkages to tuberculosis (TB) care
  • Voluntary medical male circumcision (VMMC)

Prevention benefits of ART

WHO based on the results of a study conducted in 2011 recommended that all the HIV infected individuals should receive ART to prevent the transmission of this deadly condition. Also, a study conducted in 2019 reported negligible transmission risk of HIV in individuals on ART.

Pre-exposure prophylaxis (PrEP) for HIV-negative partner

Pre-exposure prophylaxis is recommended for all the individuals who are at a greater risk of HIV infection such as, trans-genders, hetero and homosexual couples, drug abusers, pregnant and lactating women.

Post-exposure prophylaxis for HIV (PEP)

Post-exposure prophylaxis should be used within seventy-two hours of being exposed to HIV. This includes testing, counseling, treatment with anti-retroviral for 28 days.

Harm reduction for people who inject and use drugs

Individuals who use the injections can follow the below-mentioned interventions as prevention:

  • needle and syringe programs
  • opioid substitution therapy for people dependent on opioids, and other evidence-based drug dependence treatment
  • risk-reduction information and education, and provision of naloxone to prevent opioid overdose

Elimination of mother-to-child transmission of HIV

HIV infection can be transmitted to the child or the unborn fetus through the mother during pregnancy or breastfeeding. This is called a vertical mother to child transmission (MTCT). However, this can be prevented with the treatment using antiretroviral therapy during pregnancy and breastfeeding.

Treatment

Treatment comprises of combination therapy with three or more anti-retroviral drugs. This therapy helps suppress the condition and does not completely cure it. Hence WHO recommends all the individuals suffering from HIV to take lifelong medication to lead a normal life.

The clinical research and health care system is continuously working to develop ARTs with better efficacy, tolerability. Use of dolutegravir-based or low-dose efavirenz for first-line therapy, and raltegravir and darunavir/ritonavir for second line as recommended by WHO.

Making the access to the treatment and prevention is the core goal for the upcoming year. And this aims to bring the world back on track to end the AIDS epidemic by 2030.

WHO response

The 69th World Health Assembly recommended a new “Global health sector strategy on HIV for 2016–2021”. The strategy comprises of five strategic directions that guide the countries and WHO to take necessary actions over six years.

The strategic directions are:

  • Information for concentrated action for the region/country
  • Interventions designed to have an impact on the variety of services needed
  • Delivering services equally to cover the population in need
  • Financing for the sustainability of the services in terms of cost
  • Innovation in acceleration towards future

WHO is a co-sponsor of the Joint United Nations Programme on AIDS (UNAIDS). Where it directs the activities on HIV treatment and care and the coinfection. It also jointly organizes with UNICEF, the work on elimination of MTCT of HIV.

Prevention is always better than cure! Follow these tips to notice a change in your lifestyle.

Turacoz Healthcare Solutions aims to spread awareness about HIV/AIDS. We urge the people to be aware about the condition. Following the preventive measures and seeking counseling is the best way to avoid this condition. However, for the HIV infected individuals it is best to continue with the ART and maintain a healthy diet. Nevertheless, with love and support from family and friends they can lead a happy and long life.

If you wish to contact us, click here.

 

World Diabetes Day | 2019 Awareness

The campaign “World Diabetes Day (WDD)” was launched in 1991 jointly by International Diabetes Federation (IDF) and the World Health Organization (WHO) to address the growing concerns about the rising health issues posed by diabetes. It was officially recognized by United Nations in 2006 and is marked every year on November 14th, to commemorate the birth anniversary of Sir Frederick Banting, who along with Charles Best co‑discovered insulin in 1922 (1).

The condition

Diabetes is a metabolic disorder characterized by hyperglycemia which results from defects in insulin, secretion, insulin action, or both. A long‑term uncontrolled hyperglycemia can cause damage, dysfunction, and failure of the eyes, kidneys, nerves, heart, and blood vessels (2).

Classification:

Diabetes can broadly be classified into two main categories:

  • Type 1: In this case, body’s own immune system attacks and destroys the cells in pancreas that produce insulin. Although it can occur at any age, but it is prevalent more among children and young adults who require daily dose of insulin to stay alive.
  • Type 2: This situation arises when body does not make or use insulin efficiently. it is the most common type and can occur at any age, but middle‑aged and older people suffer from this condition mostly.

Other forms of diabetes include: Gestational diabetes, monogenetic diabetes, and cystic fibrosis related diabetes (3).

Symptoms

Symptoms associated with diabetes in general includes:

  • Increased thirst and urination
  • Increased appetite
  • Fatigue
  • Blurred vision
  • Numbness or tingling in the feet or hands
  • Sores that do not heal

Unexplained weight loss (4).

Causes

  • Type 1 diabetes is a result of auto immune destruction of beta cells of the pancreas. It may also occur due to certain genetic and environmental factors, such as viruses.
  • Several factors are involved in causing type 2 diabetes such as obesity, physical inactivity, insulin resistance, genes, and a history of diabetes in the family.
  • It is believed that gestational diabetes can be caused by hormonal changes during pregnancy along with genetic and lifestyle factors (4).

Prevalence and some statistics

  • People with diabetes have risen sharply from 108 million in 1980 to 422 million in 2014. Prevalence of diabetes among adults over 18 years of age has almost doubled from 4.7% to 8.5% within the same time period.
  • Prevalence of diabetes has become a serious health concern specially in middle‑and‑low‑income countries.
  • As of 2016, approximately 1.6 million deaths were attributed to diabetes only and in 2012, around 2.2 million deaths were reported globally due to high blood glucose.
  • As per an estimate by WHO, diabetes was the 7th leading cause of death in the year 2016 (5).

The campaign and the aim

At present WDD is the largest diabetes campaign having presence in more than 160 countries and a reach to more than 1 billion people. It is represented by a blue circle logo adopted by the UN resolution on diabetes on 2007. The color blue signifies the unity among global diabetes community against the epidemic (6).

WDD serves as:

  • Platform for promoting IDF advocacy efforts throughout the year.
  • Global driver to promote the importance of taking coordinated and concerted actions to confront diabetes as a critical global healthcare (1).

What’s in store for 2019?

WDD will be observed November 14th on Thursday this year which is just around the corner. On this day, millions of people around the globe organize events and activities raising awareness about diabetes (6). The campaign projects a dedicated theme every year which runs for one or more year. For the year 2019, the theme is ‘Family and Diabetes’ with an intent to raise awareness about the effect that diabetes has on the family and support network of those who are suffering as well as promoting the role of family in the management, care, prevention, and education (1).

Diabetes affecting family members

Diabetes can be considered as a family disease since the other members of the family somehow get affected if someone, specially a child is diagnosed with it. It is for this reason that it can be regarded as a form of chronic illness like any other chronic illnesses (7).

In a survey named DAWN2 involving 2000 family members of those affected by diabetes reported that 1/3rd of those experienced a notable burden and negative impact of diabetes, including effects on their emotional wellbeing, financial situation, leisure activities, and physical health (8).

Some of the risks, that family members of those affected by diabetes, experience, can be categorized as (9):

  • Biological risk: it has been shown that there exists a correlation (0.34 and 0.38) on BMI ranges of those suffering from diabetes and their partners. Partners of those with diabetes have been found to have higher BMI than their counterparts with non‑diabetic partner.
  • Health behavioral risk: a study involving multiethnic sample of > 500 patients suffering from type 2 diabetes and their partners showed that significant correlation exists between factors such as; consumption of fat, consumption of carbohydrates, total physical activity, and indulging in smoking and alcohol.
  • Affective/emotional risk: it is reported that female partners of diabetic patients have higher mean level of depressive effect. For male partner, the mean level of depressive effect was comparatively lower but still higher than that of the control subjects.

Role of family members in diabetes management

A family can play a crucial role in managing diabetes of the affected member. Having them involved in the self‑care interventions may help in achieving positive outcomes for the diabetics (10).

Families are required to share responsibilities and reconsider role of family as a result of diabetes. Reports have suggested that low level of conflicts, unity, and efficient organization patterns are linked with better treatment adherence (11).

The Family Approach to Diabetes Management (FADM) is a novel model that focusses on determining and exploring different ways of intra family communication having either positive or negative impact on clinical outcomes while keeping patient and family self‑management at forefront. It has been shown that engagement of entire family is easy to adjust as well as cost‑effective into standard diabetes care in addition to offering positive clinical outcome pertaining to general quality of life and A1C results (12).

Studies have shown that family members while participating in health interventions for diabetes care improves their own knowledge about the disease and inculcate skills necessary to support their loved ones. Family’s participation benefits their own health behaviors and health outcomes (10).

Turacoz Healthcare Solution is committed to raise awareness about diabetes management, prevention and educating people so as to make them help their near and dear ones suffering from this chronic lifestyle disorder to maintain and live a healthy life. Family’s engagement in diabetes care can significantly improve the outcomes and also make other family members learn about the management of diabetes.

If you have any queries, email us at [email protected]

 

References 

  1. About World Diabetes Day. International Diabetes Federation. Available at: https://worlddiabetesday.org/about/
  2. Diagnosis and classification of diabetes mellitus. American Diabetes Association; 2013: 36(S1). 67‑74. Available at:https://care.diabetesjournals.org/content/36/Supplement_1/S67
  3. What is diabetes? National Institute of Diabetes and Digestive and Kidney Disease. Available at: https://www.niddk.nih.gov/health-information/diabetes/overview/what-is-diabetes
  4. Symptoms and causes of diabetes. National Institute of Diabetes and Digestive and Kidney Disease. Available at:https://www.niddk.nih.gov/health-information/diabetes/overview/symptoms-causes
  5. World Health Organization. Available at: https://www.who.int/news-room/fact-sheets/detail/diabetes
  6. Getting Ready for World Diabetes Day 2019. Diabetes self‑management. Available at: https://www.diabetesselfmanagement.com/blog/getting-ready-world-diabetes-day-2019/
  7. The family approach to diabetes management: Theory into practice toward the development of a new paradigm. Diabetes Spectrum. 2004; 17(1): 31‑36. Available at: https://spectrum.diabetesjournals.org/content/17/1/31
  8. Family matters in diabetes. The Lancet Diabetes and Endocrinology. 2018; 12(6): 911. Available at: https://www.thelancet.com/journals/landia/article/PIIS2213-8587(18)30317-6/fulltext
  9. Fisher L. Family relationships and diabetes care during the adult years. Diabetes Spectrum. 2006; 19(2): 71‑74. Available at: https://spectrum.diabetesjournals.org/content/19/2/71
  10. Baig AA, Benitez A, Quinn MT et al. Family interventions to improve diabetes outcomes for adults. 2015; 1353(1): 89‑112. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4624026/
  11. Ahmed Z, Yeasmeen F. Active family participation in diabetes self‑care. A commentary. Diabetes Management. 2016; 6(5): 104‑107. Available at: https://www.openaccessjournals.com/articles/active-family-participation-in-diabetes-selfcare-a-commentary.pdf
  12. Solowiejczyk J. The family approach to diabetes management: Theory into practice toward the development of a new paradigm. Diabetes Spectrum. 2004; 17(1): 31‑36. Available at:  https://spectrum.diabetesjournals.org/content/17/1/31

Diabetes Prevention Tips

According to statistics by the WHO, “The number of people with diabetes has risen from 108 million in 1980 to 422 million in 2014.” Also, “In 2016, an estimated 1.6 million deaths were directly caused by diabetes. Another 2.2 million deaths were attributable to high blood glucose in 2012.”
It is astounding how many people are affected by this chronic disease. Diabetes occurs when the pancreas does not produce enough amounts of insulin for the body or when the body cannot effectively make use of the insulin it produces. Insulin is essential to the body as it is responsible for regulating blood sugar. Unbalanced (high) blood sugar levels are what causes diabetes.
Diabetes is categorized into the following four types:

Figure 1: Types of diabetes

Insulin is the hormone which is highly essential for maintaining proper blood sugar levels, for the adequate functioning of the entire body. If, for some reason the body produces unbalanced levels of this hormone, over time, high blood glucose can lead to the following problems:

Figure 2: Problems due to high blood glucose levels

 

Diabetes imposes many restrictions on life and one can take several steps to prevent developing it. Here are some of the suggested diabetes preventions tips:

Exercise daily:

The most common advice anyone can give to stay mentally and physically fit is to workout daily. The applications of exercising daily are endless and when it comes to preventing diabetes, it is highly beneficial. Exercising regularly increases the insulin sensitivity of your cells. This basically means that less insulin is used up to keep your blood sugar levels under control.

A study published on NCBI found that people with prediabetes who trained under moderate-intensity experienced an increase in insulin sensitivity by 51%. And people who adopted high-intensity exercises measured an increase of 85%.

Even though the results vary, it’s totally up to you to choose what style of training program you wish to follow. Straining your body will do you no good, but also taking it casually will never be beneficial.

Quit Smoking:

Smoking has been associated with many major diseases and conditions. It has been proven to be the major cause of many health conditions, which includes heart diseases and cancer to various organs, such as the lungs, mouth, breast, digestive tract and prostate. Tobacco usage has no proven benefits and even second-hand exposure to tobacco smoke can be very harmful.

A research paper published in 2012 on the NCBI website states that smoking and second-hand smoke exposure is linked to type 2 diabetes.

An analysis of over one million people, showed that smoking was found to increase the risk of diabetes by 44% in average smokers.

Once you quit smoking, the effects on the body it had seem visible as they subside. Smoking is closely linked to the risk of diabetes, and quitting has been shown to reduce this risk.

Avoid processed foods:

Fitness cannot be achieved if you aren’t doing justice with your diet. Any experienced athlete or bodybuilder will always say one thing, 70% diet and 30% gym is what results in a fine toned body. Processed or “junk” food damages your body from both the inside and outside. It is linked to various heart diseases, obesity and to diabetes.

These food products are high in vegetable oils, refined grains and preservatives, which when consumed over a long period of time, increase the risk of developing diabetes. Cutting back on these unhealth packaged foods can prove to be very helpful.

To be healthier, from both the inside and outside, it is recommended to adopt a diet consisting of minimum amounts of carbs and a diet high in fiber. Also portion control is one thing that people should be conscious about. Believe it or not, eating an unhealthy amount of healthy food can also lead to many unwanted problems.

Visit your doctor from time to time:

Get yourself checked annually. One of the best ways to stay on top of any disease or ailment is to be aware of it before the symptoms start to set in. At your annual physical, make sure to get a blood pressure check, an eye exam, and screenings for other complications such as kidney damage, nerve damage, and heart disease. To make sure you aren’t developing diabetes, blood-glucose levels also need to be measured.

Prevention is always better than cure! Follow these tips to notice a change in your lifestyle.

Turacoz Healthcare Solutions aims to spread awareness about diabetes. We urge the people to exercise regularly and stay fit. Adopting a balanced diet and limiting the intake of sweet substances is highly beneficial and helps in cutting down the risk of developing diabetes. Smoking is one habit that should be dropped. Quitting the use of tobacco products not only helps with reducing the risk of diabetes but also other bodily diseases such as cancer and heart diseases.

If you wish to contact us, click here.

Medical Writing for Disease Management Platforms

Disease management programs (DMPs) are defined as “structured treatment plans that aim to help people manage their chronic disease in a better way and to maintain as well as improve quality of life”. The main components of disease management programs are mentioned in Figure 1.

Figure 1: Components of Disease Management Software

By application, the care management solution is classified into chronic care management, disease management and utilization management.

Disease Management Software’s

According to Markets and Markets™ report, the disease management software market is expected to reach USD 37.94 billion by 2027 from USD 14.12 billion in 2019. This may be attributed to the rising geriatric population and burden of chronic diseases.

The disease management software is used to manage, monitor, and process patient data by connecting to electronic health record (EHR) and other healthcare data sources. It aims to reduce healthcare costs and promote government initiatives to assist patient-centric care. The high growth in this segment can be attributed to the ability of these solutions to reduce the cost of care with the help of protocol management and prevent episodes of ill health through comprehensive health management.

To be included in Disease Management Software category, a product must have the following characteristics as mentioned in Figure 2.

Figure 2: Characteristics of Disease Management Software

Some of the examples of disease management software are mentioned in Figure 3.

Figure 3: Examples of Disease Management Software

Mobile Health Apps for Disease Management

Due to widespread use of smart phones and tablet computers, disease management via mobile health apps is easy and is expanding rapidly. Around 3.7 billion apps were downloaded in 2017 and is expected to grow by 16% within the next year. Many apps are available in play store and iTunes for clinical disease management and patient self-management of conditions including asthma, diabetes, heart disease, cancer, and even autism and insomnia. These apps help both doctors and patients as money can be saved by patients and doctors can save on labour force. Some of the apps for chronic disease management are mentioned in Figure 4.

Figure 4: Examples of Disease Management Applications

Poor Usage of Disease Management Software’s and Mobile Apps

One of the reasons why the healthcare apps or software’s fail is because of the lack of understanding about the healthcare apps. Most of the health care apps get uninstalled either due to the highly scientific content which is difficult for the laymen to understand. Apps with very basic scientific content also fail to impress the audience. Therefore, it essential to involve a medical writer who has a scientific background and knows the subject comprehensively. The content for such software’s or apps must be developed based on patient’s requirement, target audience and should be specific to a region.

Role of Medical writing in Developing Health Related Software’s and Mobile Apps

According to Grand View Research, global medical writing industry is expected to reach USD 3.75 billion by 2026. Medical writers are involved in analysis and reporting of retrospective and prospective clinical trials, research methods (descriptive and predictive), health economics, and evaluation of disease management initiatives. Medical writers also play a key role in developing applications for mobile devices that are used in multiple ways, such as:

  • Disease management
  • Continuing education and training
  • Medical reference and information-gathering
  • Practice management and monitoring

The medical writer creates informational or instructional materials for use in health or medical context. These materials allow different audiences to understand health and medical situations or practices, perform certain health or medical-related activities, or use a health/ medical product/ mobile health apps or device. Medical writers must have the following skills to develop medical content:

  • They must possess medical and therapeutic knowledge, and must have understanding about the recent regulations and technical guidelines
  • They must have mastery in language and grammar, proof reading and editing skills, ethical and legal issues related to writing
  • They must have creative writing skills to articulate the scientific information in clear and approachable language
  • As scientific writers are involved in creating content for mobile medical apps and other disease management software’s, it is essential for them to possess instructional designing skills

Writer Groups Initiative in Developing Disease Management Programs

The heterogeneity of disease management programs has made it difficult to compare and evaluate different programs. The American Heart Association’s Disease Management Taxonomy Writing Group developed a taxonomy or system of classification to classify and compare different disease management programs and to inform efforts to identify specific factors associated with effectiveness.

The writers did a MEDLINE (Medical Literature Analysis and Retrieval System Online) search on the terms heart failure, diabetes, and depression, together with disease management, case management, and care management. English articles published between the time period 1987 and 2005 were considered for the program. The following studies were considered:

  • Interventions designed to improve outcomes and/or reduce medical resource utilization in patients with,
  1. Heart failure
  2. Diabetes
  3. Depression
  • Clearly defined protocols with at least two prespecified components traditionally associated with disease management

A taxonomy was developed by the writer’s group with eight domains. A graphic representation of the taxonomic structure and subdomains are found in the Figure 5.

Figure 5: Taxonomic Structure and Subdomains

Turacoz Healthcare Solutions understands its professional responsibility and takes an initiative to make authors and medical writers aware about their role in developing disease management programs. Turacoz is a medical communication company that provides scientific/medical writing support to the industry and academicians.

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Biosimilars: Advantages & Challenges

Introduction

A biosimilar product, as defined by USFDA, is “a biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product.” By 2020, the biosimilar market is expected to reach $15 billion booming market, which is thrice the presentmarket(Ragunadhan 2018).Latest additions to this category of drugs are Hadlima(adalimumab-bwwd), Ruxience (rituximab-pvvr), Zirabev (bevacizumab-bvzr) and Kanjinti (trastuzumab-anns), which were approved on June, 2019(USFDA).

Advantages of Biosimilars

Biosimilars are nowadays gaining significant interest due to the advantages associated with it. They are as follows(Ragunadhan 2018)

  1. Reduction in cost:Biosimilar drugs are similar to original drugs, produce equivalent clinical outcomes to that of the original biologics but are less expensive (because their development is not associated with some of the costs borne by pharmaceutical companies in the development of reference agents).The reference drug monopoly is broken when multiple biosimilars are introduced in the market.
  2. Improved patient accessibility: As a number of biosimilar drugs are being launched in the market, and biosimilar drugs are found to reduce the healthcare cost by 40%, more patients can have access tosuch medical innovations at an early stage.
  3. Incentives for innovation:In the wake of expiring patents on reference drugs, innovative and patentable new biologic products may be necessary to maintain a large market share. This will encourage the pharmaceutical companies to invest more to foster innovation in biosimilar drugs.

Challenges of Biosimilars

Despite the benefits, there are few challenges and issues faced by biosimilar market which are as follows(Ragunadhan 2018, Stenger 2018)

Figure 1: Challenges of Biosimilars

Figure 1: Challenges of Biosimilars

  1. Education:Mass education is required in healthcare and pharmaceutical industry/patient and prescriber to enlighten them on the benefits of switching to biosimilars.
  2. Extrapolation issue:“Extrapolation is the process of granting a clinical indication to a medication without its own or new clinical safety and efficacy studies to support that indication”. Guidelines need to be developed to avoid confusion over whether the biosimilar can be used for the off-labelindications also.
  3. Interchangeability issues:Interchangeability issues ariseas the reference product can be substituted with biosimilar. Though guidelines have been published, there is uncertainty prevalent at the prescriber and pharmacist level.
  4. Rare diseases:Orphan drugs are developed for rare diseases. Though biosimilars are developed for the same, but there are many obstacles. It is a challenge to obtain sufficient  non-heterogeneous population for trials. Also, the cost for developing biosimilars to run batch-to-batch variability studiesis high.
  5. Approval process:Common challenges faced by biosimilar manufacturers in processing and packaging are the variability in critical quality attributes between the biosimilar drug and the reference drug which requires manufacturer to provide the FDA with adequate proof of clinical safety.
  6. Post-marketing reporting: As there is no clinical data available, post marketing surveillance is the only tool available to assess the efficacy and safety of biosimilars. However, as the post marketing surveillance process is a herculean task as felt by clinicians, many do not participate in the samedue to time and resource constraints.

Future of biosimilars

There will be a giant leap in biosimilar market in the coming decades(Ragunadhan 2018). As the reference products are nearing their expiry date, the biosimilars market is poised for added growth. Also, it is essential for the professional organizations to provide education and training about biosimilar drugs. This would spread awareness among consumers and healthcare professionals about opportunities and the challenges that these new agents are associated with.

Turacoz Healthcare Solutions, being an active provider of medical communication services, aims to inform people about the advantages and challenges of biosimilars. For any queries, write to us at [email protected]

References

Ragunadhan, M. (2018). Biosimilars: Benefits, Challenges and Futurehttps://blog.kolabtree.com/biosimilars-benefits-challenges-and-future/.
Stenger, M. (2018). “Opportunities, Issues, and Challenges for Biosimilars in Oncology.”  https://www.ascopost.com/issues/july-25-2018/opportunities-issues-and-challenges-for-biosimilars-in-oncology/.
USFDA “Biosimilar Product Information.”

INNOVATIONS IN PEER-REVIEW

Peer Review is the process of evaluation of manuscripts submitted for scientific publication in journals/books, pre-clinical or clinical study reports, research progress reports etc., by experts or peers with similar competence as manuscript authors. It plays a pivotal role in scholarly publications with objective to ascertain quality, reliability and credibility of the work reported in the manuscripts and reports through qualitative scrutiny. This contributes to the acceptability of scientific work as authentic, rigorous and coherent for the intended purpose. Also, it widens networking opportunities within the scientific fraternity.

Types of Peer Review

  • Single blind review: This is the traditional and most common type of review in which the reviewer’s name is hidden from the author.
  • Double-blind review: In this kind of review, there is anonymity of both the author and the reviewer to each other.
  • Open review: The identity of the author and the reviewer are known to each other and there is more transparent communication during the review process.

Peer-review is a golden practice to improve the quality of publications but comes with its own set of disadvantages and shortcomings. Table 1 details the various featural pros and cons of different types of peer-review.

Table 1 Advantages and Disadvantages of Peer-Reviewing [1]

Ethics of Peer Review

As the reviewing experts are essentially from the same area or field of the study as of the authors of documents under review, some conflict of interests or differences in viewpoints may introduce bias that might come in the way of a fair peer review. For instance, a reviewer may not accept the manuscript/report under review if the author’s hypothesis is different from that of the reviewer. Indeed, many journals take this possibility into account and allow the authors submitting manuscripts to give the name(s) of reviewers to whom the manuscript should not be sent for review in addition to names of reviewers the authors would like to recommend. But then, peer review by reviewers recommended by the authors may also occasionally lead to undeservingly favored evaluation.

To avoid undesirable contentions, it is a prerogative for a peer-reviewer to adhere to ethical guidelines outlined by the Committee of Publication Ethics (COPE), which categorises the ethical responsibility of a peer-review into confidentiality of the data reviewed, objectivity of the review process and diligence towards their competency, following processes, policies and conduct [6].

A few ethical practices that should be incorporated in peer-reviewing are as follows:

  • Maintaining objectivity and diligence in assessing a document
  • Avoiding any favoritism or likewise, negative bias
  • Respecting confidentiality of the manuscript
  • Avoiding giving any personal or derogatory remarks
  • Refraining from disrespectful tone of criticism
  • Maintaining timeliness
  • Adhering to the rationales, norms, policies and specific scope of the journal
  • Promptly reporting any unethical duplication or data fabrication/design
  • Staying discrete from the author during the review process to avoid any unwanted confrontation

Essential Components of Peer-Reviewing

Studies conducted by scientists/experts/professional are rendered into a detailed article or manuscript, a draft of which is then sent to the journal editor. The article is sent by the journal editor to peer reviewers before publication. The reviewers then assess the manuscript and extend their comments focusing on the following aspects:

  • Adequacy of the background information (literature survey) justifying the necessity and purpose of the study reported
  • Appropriateness and adequacy of the materials and methods employed to generate the data
  • Compliance to national and international regulatory requirements [e.g. Good Laboratory/Manufacturing/Clinical Practices (GLP/GMP/GCP), Animal ethics, OECD/ICH/USFDA guidelines etc.]
  • Analysis of data using appropriate (statistical) methods
  • Proper interpretation and discussion of the data/results and the conclusions drawn.
  • Originality of the study
  • Presentation of the manuscript relying on legible and comprehendible language that is grammatically, technically and scientifically correct

Innovations in Peer Review

Any advancement or innovation in a process primarily requires recognition of the prevalent roadblocks. “Necessity is the mother of invention”, Plato’s misattributed proverb reflects the rationale of some compelling advancements that peer-reviewing attributes to the share of challenges it had faced.” Addressing some fundamental conundrums, there are many driven groups across the scientific fraternity who have offer valuable innovative answers.

  • Raising the satisfaction quotient of the author-reviewer-editor trilogy by ‘Volunpeers’

Lack of familiarity with the subject matter causes many reviewers to decline from reviewing. To overcome this challenge, the journal of Molecular biology enabled a Reviewer Recognition Platform, that facilitates reviewers, christened as Volunpeers (to represent the rationale of this platform), to register for their area of expertise and receive manuscripts for reviewing according to their preference. The outcome of this platform was impressive! It proudly flaunted a high rate of involvement and satisfaction from both the reviewer and the editor and establishes a faith that peer reviewing indeed has not reached an intimidating stagnancy. Figure 1 indicates the promisingly positive impacts of Volunpeer-ing on various critical aspects [2].

Figure 1: Impact of Peer-Reviewing through the Reviewer Recognition Platform ‘Volunpeer’
  • Expediting the process of review and making it less cumbersome and time‑consuming

The dichotomy of time versus quality lead many to attempt to address long and tiresome process of reviewing. Recently, The Journal of Bone & Joint Surgery (JBJS) has initiated below mentioned tiny steps to upgrade their overall peer-review process [3].

  • Automated and weekly reminder emails to editors
  • Weekly reminder emails for editor queue statistics
  • Monthly emails delineating acceptance rates and transfer rates by editor
  • Shortened deadlines for peer-reviewing
  • Addition of manuscript Xtract in Editorial Manager that reduces manual entry for basic data like manuscript title, author-names, abstract and affiliations
  • Refining the review process by spotting errors and maintaining quality standards of review

The quality of any manuscript proportions directly to the errors established during review and editing process. A keen study conducted on ‘Improving the peer-review process and editorial quality by studying key errors escaping the review and editorial process in top scientific journals [4]. Figure 1 shows the common trend of errors encountered during review.

Figure 1: Proportion and types of errors during review/editing process [4]

The recognition of these error-patterns led to the application of a novel mistake index, independent of the journal’s impact factor. Mistake Index Total (MIT) represented the fraction of corrections published by total number of items published in a year and Mistake Index Paper (MIP) represented the fraction of corrections published by the total number of papers (categorised by articles) published in a year. These were then statistically analysed and applied on scientific journals of diverse disciplines to determine the type, rate of occurrence and severity of errors encountered. It is hence recommended that a detailed guideline based upon MIT and MIP be provided to reviewers, authors and editors, which can help them minimise error redundancy, reduce time-to-correction and reinforce quality of published manuscripts [4].

  • Ensuring recruitment of competent reviewers and providing visibility, value and appreciation for their efforts by R-index

On a more humane level, getting good reviewers and providing visibility, value and appreciation for their efforts stays a huge contributing factor to optimising the quality and efficiency of peer-review. Lack of recognition of time and valuable expertise of the reviewer often is a big dampener for review quality. A simple yet cutting-edge R-index (Reviewer index), has emerged as an essential metric to quantify and credit a scientist’s contribution as a reviewer, regardless of his/her stage of career. Based on the list of reviewers for any particular journal, number of papers reviewed, total number of words against the journal’s impact factor, and eventually fostered by the editor’s feedback on individual review, a score ranging from 0 to 1 is credited to the reviewers. Widely being accepted and implemented, this index is open doors to a wider academic productivity and increased transparency within the scientific community and works reciprocally towards maintaining and enhancing the quality of reviewing [5].

Conclusion

With a fair share of recognition as well as criticism that it comes with, peer-review is undoubtedly an essential component of the publication world. Although an overall positive impact and effectiveness of peer review mechanism to improve upon quality in biomedical journals has been observed in clinical trial and other comparative study publications, it is still difficult to ascertain its tangible impact, considering the aforesaid challenges [7]. Nevertheless, the brighter side shows that the existing peer-review paradigm is inevitably treading towards innovations; profoundly embedded into the process of scientific progress, its indispensable purpose gives reasons enough to boost its operations and we hope to witness more streamlining, transparency, efficiency, robustness and inventive tableaus in its modus operandi.

Turacoz Healthcare Solutions aims to provide information on the latest trends, updates and advances to help researchers stay abreast of important innovations in peer-review in the field of scientific publications. Turacoz Healthcare provides an end-to-end support for scientific communications, clinical trial documents and disclosures, regulatory documents writing and submissions, and medico-marketing writing along with e-modules & e-books on healthcare and research.

Reference

  1. https://www.elsevier.com/en-in/reviewers/what-is-peer-review
  2. https://www.elsevier.com/connect/reviewers-update/innovation-in-peer-review-introducing-volunpeers
  3. https://www.csescienceeditor.org/article/new-innovations-in-peer-review/
  4. https://peerj.com/articles/1670/
  5. https://royalsocietypublishing.org/doi/full/10.1098/rsos.140540
  6. https://www.aje.com/arc/ethics-peer-review/
  7. https://www.bmj.com/content/349/bmj.g4145

Here is Everything You Should Know About Cystic Fibrosis

The month of May is commemorated as Cystic Fibrosis Awareness Month. It aims at raising awareness about cystic fibrosis (CF). Cystic fibrosis foundation (CFF) sponsors this month.

According to estimates, more than 70,000 people globally are affected by cystic fibrosis, but the prevalence of the condition varies globally. The US alone accounts for around 30,000 people living with cystic fibrosis. Around 1000 new cases of cystic fibrosis are diagnosed every year in the US. More than 75% of these cases are of children of age 2 or below. Asia and Africa are thought to be under-diagnosed for CF. Many nations don’t screen for CF in new-borns unlike the US, and the nation registries suffer from lack of data.

What is Cystic Fibrosis (CF)?

CF is a genetic disease that has an impact on lungs and digestive system of human body. Under the influence of this condition, the body produces thick and sticky mucus that can lead to blockage of lungs and obscure pancreas.

In individuals with CF, metamorphosis in the cystic fibrosis transmembrane conductance regulator (CFTR) gene makes the CFTR protein debilitated. When this protein doesn’t function properly, it is incapable of moving chloride- a salt component- to the surface of cell. Without the chloride to bring water to the surface of cell, the mucus in different organs turns thick and sticky.

The mucus blocks the airways and entrap germs such as bacteria, in the lungs, which lead to infections, soreness, respiratory issues and other complications. The people with CF need to be extra cautious and avoid contact with germs.

The thickening of mucus can also lead to infertility in males by clogging the vas deferens or the tube responsible for carrying sperms from testes to urethra.

Symptoms of CF:

Mentioned below are some prominent symptoms of cystic fibrosis:

  • Skin tasting very salty
  • Continual coughing
  • Running out of breath
  • Breathing roughly/heavily
  • Persistent lung infections inclusive of pneumonia or bronchitis
  • Problem with gaining weight despite of heavy diet
  • Infertility in males
  • Greasy and heavy stools
  • Troubles with bowel movements
  • Nasal polyps or slight fleshy growth in the nose

Due to the obstruction in lungs, infections like bronchitis and pneumonia can occur in the patient, leading to growth of pathogens. Blockage in pancreas contribute to malnutrition and poor growth. The risk of developing osteoporosis and diabetes is also associated with it.

Causes of Cystic Fibrosis:

Since CF is a genetic disease, to be affected by it one is required to inherit the mutated gene from both of their parents. The mutated genes are the carriers of codes that produce protein controlling the flow of salt and water on the surface of organs, inclusive of pancreas and lungs.

People suffering from CF struggle with the balance of salt and this leads to more salt and water on the surface of cells and formation of very thick mucus.

Individuals with a single copy of the mutated gene are known as carriers. They do not fall prey to the condition or symptoms of CF. For someone to be affected by CF, both their parents must be the carriers.

If two people are carriers and have a child together, there are:

  • 25% chances that the kid will have CF
  • 50% chances that the kid will be a carrier, but won’t suffer from CF
  • 25% chances that the kid will neither be the carrier and nor suffer from CF

Treatment for CF:

At present, CF is not curable. Certain treatments work on controlling the symptoms and improving quality of life for CF patients. Depending on the kind and intensity of symptoms, the treatments are personalized.

Clearing airway

It is very important for CF patients to reduce the level of mucus in their lungs in order to breathe easily and avoid any lung infections.

Airway Clearance Techniques (ACT) helps individuals with CF to soften their mucus and get rid of it from their lungs. Inhalable medications are effective in reaching the airways and are usually used. The medication can be given through aerosol or through inhalers. These medications help in thinning mucus, killing bacteria and setting off mucus to enhance airway clearance.

Antibiotics act as an essential part of routine care. These can be consumed orally, through injecting and inhalation. Some other medications like azithromycin and ibuprofen are said to protect and enhance lung function and now made a part of standard therapy for CF patients.

CF patients can lower the risk of developing lung infections by taking the below mentioned steps:

  • Washing hands often
  • Avoid smoking
  • Avoid futile contact with people suffering from cold or other contagious diseases
  • Getting a flu injection every year

Other styles of treatment:

Other than the airway clearance technique, there are other types of treatment too.

Implanted devices:

These allow long-term contact with the bloodstream for constant supervision of drugs. These are capable of making the management of CF more powerful and less invasive.

CFTR Modulators:

CFTR (CF Transmembrane Conductance Regulator) modulators are the recent medications developed to focus on the defective CF-causing gene. They help in easing the flow of salt and fluids on the expanse of lungs and weed out the heavy mucus that CF patients generally form in their lungs.

At present, two CFTR modulator brands are certified by FDA (Food and Drug Administration), namely Orkambi and Kalydeco. They’re recommended for children suffering from 10 distinct mutations of the CF-causing gene. Kalydeco might be recommended for kids of age 2 years or more, whereas Orkambi is for kids aged 6.

Remedial measures based on Nutrition:

CF affects the digestive system adversely and the patient suffers from poor nutrient absorption. It is recommended that CF patients should consult their doctor regarding their diet. A nutritionist would assist them in having a control of digestive symptoms.

To balance the digestion of nutrients, a variety of additional supplements like pancreatic enzyme supplements, vitamins or salt might be required along with a specific kind of diet.

CF is responsible flawed growth. To ensure proper development and growth in affected children, a diet rich in calorie and fat, is very essential. It also helps adults in maintaining optimum health. Good nutrition is very crucial for CF patients so that they can be safeguarded against high risk of lung infection.

Cystic fibrosis cannot be cured as of now but with proper care, treatment and diet, the symptoms of it can be controlled. The average life expectancy of CF patients is early 40s. The life expectancy may vary based on the intensity of the symptoms, age of diagnosis and the kind of mutation in gene.

The life expectancy of CF patients has increased significantly in last few years, being around 47 years. There are many patients living well in their 50s or 60s.

Turacoz healthcare solutions, a medical communications firm, believes that appropriate treatment and caution is the key to control currently incurable diseases like cystic fibrosis. Turacoz provides cost-effective medical writing services like regulatory writing, publication writing, advisory board meetings, etc. To know more about Turacoz and to avail the services, drop a mail at [email protected]

Talc, a cosmetic ingredient: Safety issues

Most of us have possibly used it or sprinkled on our skin at some point in our life, ‘Talc’ which is a processed from of soft mineral compound of magnesium silicate and is called talcum powder or just talc in general terms. The natural smoothness and adsorbency of talc have been utilized since millennia and its use dates back to the Egyptian time. Some of the major brands utilizing talc’s adsorbent properties are Nivea, Pond’s, Cinthol and Johnson & Johnson. Ideally, cosmetic grade talc should not contain asbestos but recent lawsuits against Johnson & Johnson have claimed its presence in the marketed cosmetic products.

Non-clinical Findings

In 1993, the National Toxicology Program (NTP) in their report stated that there were some evidence of carcinogenic activity in male F344/rats, clear evidence of carcinogenic activity in female F344/N rats, and no evidence of carcinogenic activity in male or female B6C3F1 mice exposed to aerosols of 6 or 18 mg/m3 non-asbestiform cosmetic grade talc in a lifetime study. In 2010, the International Agency for Research on Cancer (IARC) Working Group reported that there is a limited carcinogenicity evidence for talc (not containing asbestos/asbestiform fibres) in experimental animals.

Clinical Safety Alerts

Talc has been safely used and is well tolerated since many years and recent scientific reviews on available data have supported this position lately. However, the first alert associated with genital was reported by identification of talc particles in ovarian cancers which came in 1971.

This finding was strongly contested by Dr G.Y. Hildick-Smith, Johnson & Johnson’s medical director. A subsequent publication in the Lancet warned that “The potentially harmful effects of talc in the ovary should not be ignored”. This warning was confirmed in a 1992 Obstetrics & Gynaecology publication, reporting that a woman’s frequent talc uses on her genitals increased her risk of ovarian cancer by threefold. The talc in question was simple brand or generic ‘baby powder’.

Unexpectedly, the mortality of ovarian cancer in women over 65 years of age has escalated sharply, especially in black women who have a higher rate of talc use as compared to other races. Almost 16,000 women in the United States die from ovarian cancer yearly, by some estimates, one out of five women regularly applies talc to her genitals either via direct application, or from tampons, sanitary pads and diaphragms that have been dusted with talc.

Conclusion

IARC reports perineal use of talc-based body powder to be possibly carcinogenic (Group 2B) in humans, and that inhaled talc (without asbestos or asbestiform fibres) is not classifiable as to its carcinogenicity (Group 3). Additionally, the US Cosmetic Ingredient Review Expert Panel published a safety assessment of talc as used in cosmetics. It concluded that talc is safe for use in cosmetics in the present practices of use. Johnson & Johnson faced continued concerns on about the threat posed by lawsuits over the safety of the company’s signature baby powder. The company has always denied the allegations and maintained a swift stance on the safety of talc.

At Turacoz Healthcare services, we provide end to end toxicology and regulatory assistance to meet the high standards set by the regulators worldwide. We provide exhaustive toxicology/safety literature search from pre-clinical to post-marketing stage. We provide consultation at various stages of product lifecycle in order support the ingredient compliance with the guidelines of respective regulatory bodies.

Regulatory Troubles Clamping Down on OTC and Other Healthcare Products

The regulatory authorities have been on fire lately. They are vigilantly sniffing any suspicious and harmful substance in healthcare and OTC (Over the Counter) products. They are working towards the standardization of products which has added to the woes of some famous names as well.

Everything going wrong with Johnson & Johnson (J&J)

The most popular baby product brand Johnson & Johnson lands into trouble again. This time The Rajasthan Drugs Control Organization has indicated that two batches of company’s “No More Tears Baby Shampoo” had ‘pernicious elements’, to which J&J, not long ago, has classified as carcinogen formaldehyde and has denied the test results.

Earlier, the baby powder of the company was also in news and that was because of no good reasons. The baby powder of the company was suspected of having asbestos (a cancer-causing element).

Only a month ago, the US healthcare colossal got clean chit from the government and proceeded again with the production of their baby powder at their plants in India. Now they are encountering troubles with the baby shampoo and are on the radar of domestic drug regulatory authorities.

This is a serious threat to the image of J&J and their well-established market in a place like India. Two batches of J&J’s baby shampoo failed the quality test, as per the reports by Indian Express. The samples of the batches BB58204 and BB58177, to be expired in September 2021, were tested positive for harmful and objectionable ingredients.

These samples containing one lakh bottles of “No More Tears Shampoo” were manufactured at Baddi, Himachal Pradesh. Rajasthan government has asked to withdraw these adulterated batches and has demanded the regulatory authorities of other states to follow the litigation.

The regulators found the presence of formaldehyde in the samples of shampoo. Formaldehyde has been declared as a probable carcinogen substance by the US Environmental Protection Agency. The studies conducted in past have shown a link between formaldehyde and a greater risk of leukemia.

Rajasthan drugs auditors relayed a notice to drug control officers to withdraw the available stock, so that the stocks of these drugs are not used by anyone and the consumers are safeguarded. Further, it was also notified to take appropriate actions in accordance with provisions of the Drugs and Cosmetics (D&C) Act 1940 and rules made afterwards.

J&J has though, denied any such allegations. It has claimed that neither did the government revealed the method of testing used and nor did it state the details and quantitative findings. A J&J spokesperson said that the samples were drawn at the start of this year and the company has extended full support during the whole process.

J&J stated that they had been inveterate to the Indian authorities that they have forbidden adding formaldehyde to their shampoos and nor does they use any such element in their shampoos that can release formaldehyde with time. J&J also claimed that their products are safe to consume and are manufactured in accordance with the standards of D&C Act and rules.

J&J has declared that they extend their full support to Indian regulatory authorities and act according to their regulatory requirements. The US healthcare giant has also applied for re-testing of their samples at Central Drugs Laboratory.

Adding to J&J’s anguish, Central Drugs Standard Control Organization (CDSCO) has planned to investigate the matter more scrupulously.

Reviewing of dispensations to Dettol, Savlon and other antiseptics, by the panel

Dettol, Savlon and other products of similar nature are liberated from getting a sale permit, as per Drugs and Cosmetics Rules, 1945. An expert panel now has been set up by Drug Controller General of India (DCGI), which will be deciding whether OTC healthcare products will be proceeding further with an exemption under disinfectants and antiseptics.

According to clause 12, schedule K of the Drugs and Cosmetics Rules 1945, “substances intended to be used for annihilation of vermin or insects, which produce disease in human beings or animals, like insecticides and disinfectants, can be stocked, exhibited and sold without a license.”

Currently products like Savlon, Dettol, etc. fall under the clause 12, schedule K. This ensures that they do not need any sales license. This matter, however, has now been consigned to a sub-committee for further investigation. It shall also be reviewed whether these products can be kept under the category of OTC products or ‘no-prescription’ products.

Dettol is a popular first-aid product, used as a disinfectant and it contains additives like terpineol, chloroxylenol and absolute alcohol. The reason for this action is to ensure the safety measure of these products. Such products, being a crucial part of infection control strategies in healthcare regimen, are required to be monitored closely. It is also because these products play a major role in antimicrobial resistance, so their manufacturing and usage becomes even more crucial.

The US Food and Drug Administration (FDA) also took a similar action in the year 2017, when it shut down the use of 24 elements in OTC antiseptic products like handwashes and surgical hand scrubs.

Things not going smooth for Claire

No one can deny the fact that cosmetics have been deeply rooted into the daily routine of our lives and hardly any woman walks out without wearing makeup or using any sort of cosmetic products. The widespread use of cosmetic products has made it even more important to screen them carefully in order to avoid any possible harmful effects.

With a wide range of cosmetic brands available, more vigilance is required. Recently, a popular cosmetic brand, named Claire, has been under the radar of FDA.

FDA called on Congress to alter the rules for cosmetic safety as it broadcasted an alert for consumers against 3 of the products sold by Claire Stores Inc. This was because these products were tested positive for asbestos- a product that causes cancer. The presence of any carcinogen element in any product is not acceptable.

The 3 products against which the warning was issued are:

  • Claire’s eye shadow palette
  • Contour Palette
  • Compact Powder

The retailer, who just escaped from the jaws of bankruptcy, stated that there is no proof that any of the product sold by Claire is risky. Though, as a measure of precaution, the retailer removed the stated 3 products from the store and any other such product that was talc-based.

Claire, however, has challenged the test results shown by FDA and says that it has misunderstood fibers present in the products as asbestos.

FDA has been under huge pressure to screen for any asbestos presence in the products, especially after the J&J case, where asbestos was found in their baby talcum powder. The reports from the Reuters stated that J&J was aware that their talc, in raw form, contains asbestos, from 1970s to early 2000s.

No favor to flavor: FDA plans on imposing restrictions on Flavored E-cigarettes sales to teens

The commissioner of FDA has decided to put a restriction on the sale of flavored e-cigarettes in order to minimize the rate of teenage vaping.

Vaping is practice of inhaling and exhaling vapors formed by an e-cigarette or electronic cigarette or any related device. The issue associated with this is that youngsters, especially teens might take up vaping as an alternative less harmful than smoking.

The agency has suggested in a proposal that the stores cloister flavored electronic cigarettes to areas prohibited to anyone falling below the age of 18. All retailers inclusive of departmental stores and gas stations will have to mandate the age verification of the customers.

There are enough proofs to show that youngsters are drawn towards flavored e-cigarettes and the minors have access to these from physical and online stores, despite of the fact that there are federal restrictions imposed on sale of such items to anyone below 18.

The increasing rates of teenage vaping is a serious concern over the past few years. Around 3.6 million middle and high school kids confirmed that they were involved in vaping, as per a study conducted by Centers for Disease Control and Prevention.

Previously, FDA repressed teenage vaping by issuing a threat warning to put a ban on maximum flavored e-cigarettes and asked retailers to stop selling them to minors.

The recent proposal states that the sellers need to filter the sale of such items according to the area. If any store caters to customers of all age group, then they might be required to have a separate space/room for such products, so that minors don’t have direct access to it.

Though many retailers aren’t happy with this and have even threated to fight against these stipulations in court. Conservative groups and vaping trade associations also seem to be in no mood for support and have stated that the efforts made by the agency to regulate e-cigarette industry corresponds to government overdo.

The new stipulations are not applicable on menthol, tobacco or mint flavors as the FDA wishes to keep them available for adults who are trying to quit volatile smoking with the help of e-cigarettes.

Meanwhile FDA plans to monitor the use of mint or menthol flavored e-cigarettes by the youth and upon finding excessive use by the youngsters, it would reconsider the exoneration of these products. This step is not going to be in favor of Juul labs, the vaping colossal. Juul has already shifted the sales of its products online, other than the mint and menthol flavored ones.

The proposal made is still in the draft phase and is required to abide by a 30-day comment period prior to its finalization. This regulatory approach is bit off-beat as it is neither an autonomous guideline nor a new rule. FDA has mentioned that if the e-cigarette manufacturers sell their products in contravention of the solicitation, then their products can be lifted off the market and asked to apply for approval from the agency. FDA can carry out this action under its discretionary enforcement authority.

With time, more emphasis is being given to the safety and efficacy of healthcare and cosmetic products. Proper measures should be taken to avoid the presence of any harmful substances in these products and ensure the safe usage. The safety and health of consumers is becoming a primary concern.

The regulatory authorities across the globe are working hard towards maintaining the standard of the manufacturing of these products by implementing stricter measures of screening and making amendments to the safety rules.

With the changing regulatory requirements and parameters, even the big giants need to buckle up and prepare for the best and ensure quality products from their end to stay out of any likely troubles. How things unfold in the future, would be a sight to see.

Turacoz Healthcare Solutions, being a medical communication firm, realizes the significance of drug safety and efficacy and believes that the manufacturing standards of the drugs and cosmetic products should be at par with the regulatory standards and rules. Consumer safety is a priority and the regulatory authorities are working on the same by fastening the grip on major healthcare and OTC product players, to ensure that the products are of standard quality and their consumption is safe.

Turacoz offers quality and cost-effective medical writing services. To know more about our services, write to us at [email protected]

Moving to Virtual Clinical Trials

 

In the clinical trials industry, 80% of trials do not meet enrolment timelines, leading to a loss of $8 million per day. Delayed enrolment not only impacts trial timelines, but more trials are being cancelled because of it, preventing investigators from determining the safety and efficacy of what could be promising new therapies for patients who need them the most.  This loss can be dealt through incorporation of virtual clinical trials. Unlike traditional site based clinical trials, virtual clinical trials do not require multiple study sites. Though some research space will be required for management of a virtual clinical trial, it can generally be organized from a single facility. Also, patients need not be in proximity to sites, and the data collection requirements fit more easily into their everyday routines, improving compliance and patient engagement. Greenlight insights reported that virtual industry will reach $7.2 billion by the end of 2017, and is expected to touch $74.8 billion by 2021.

Virtual clinical trial is a new method of collecting safety and efficacy data from trial participants, from scratch of the study through execution to follow-up. The participant does not have to travel to the trial site and can make use of simple mobile applications to report general information and adverse events. Body temperature and other vital signs are send directly to the electronic data capture records via wearable sensors.

What are the benefits of virtual clinical trials?

The advantages of virtual clinical trials compared to the traditional trials are mentioned below.


Figure 1: Benefits of virtual clinical trials
  1. Maximizes patient availability and enrolment: The patient recruitment phase is longest in clinical trials and almost 80% of the study fails to reach the initial target.
  2. Overcome of mobility issues: As the patient is not required to travel to the trial site or doctor’s office, it is convenient for elderly participants residing in remote area.
  3. Keep subjects engaged with the study: Almost 40% of the phase III clinical trials subjects drop out from the study due to many factors such as inconvenience in travelling, complexity of trial design and data collection procedure. However, virtual clinical trials does not require patient to travel to clinical study sites. Also, the data collection procedure is automated which increases the patient engagement and reduces the dropout rates.
  4. Better data collection: Data collection is made easy by electronic data capture records hence; the timelines can be achieved at a faster rate.
  5. Benefits to research team: With notifications, scheduling and reporting functions, researchers are freed from performing tedious administrative duties.
  6. Reduce risk in drug development process: Real-time data analysis and data cleaning can be carried out simultaneously. Based on the real time clinical trial data, decisions to terminate drugs development can be made faster.
  7. Cost effectiveness: The reduced number of sites involved in the study leads to reduction of the cost. While trial staff will likely still be based at a single site or a reduced number of sites in multi-site trials, the operating costs will be significantly lower.

Key challenges of virtual clinical trials

  1. Sometimes
    technology may fail:
    When everything
    relies on technology, challenge arises if it won’t operate optimally.
  2. Data accuracy
    problems:
    As the patients will not face the
    doctor directly, doubts exist whether ideal standard treatment care is provided
    for the patient.
  3. Conservative in
    approach:
    Corporate conservatism is another
    major challenge as it is difficult for the sponsors to move on from traditional
    method and trust the data generated from virtual clinical trials.
  4. Challenges in
    device selection:
     There are concerns that the device model, the position at which the
    trial participants wear it and other factors could introduce variability into
    the trial results.

Pioneers in virtual clinical trials

REMOTE (Research on Electronic Monitoring of Overactive Bladder Treatment Experience) trial by Pfizer in 2011 was the first virtual clinical trial. Though, the trial faced many challenges, it was the first trial to use web and smartphone based patient recruitment. Also, the patients were not required to visit the study site.

Turacoz Healthcare Solutions aims to provide information regarding the latest trend in clinical trial industry. Turacoz is a medical communications company, which offers services to healthcare professionals in clinical research, regulatory writing, publication writing, medico-marketing writing, and support for conducting medical advisory board meetings.

To know more about us and our services, write to us at [email protected]

Financial Disclosures in Medical Publishing

Introduction

Financial disclosures enable the readers to evaluate the potential conflict of interest (COI) which probably builds the trust of transparency in the medical publishing’s.

Importance

The financial disclosures are made available to the readers either in the published article or by posting the submitted financial disclosure forms online along with the published article. It allows the readers to evaluate the author disclosure with COI and analyze the financial aspect of the published material. Furthermore, it allows one to interpret the information provided in the article accordingly in the gleam of all those disclosures.

Consequences

  • Many scientific journals and funding agencies have adopted and regularized it for the authors to disclose all finance related interests to improve the uprightness of science and manage all COIs. The complete disclosure removes the inkling of hiding some relevant information regarding the object.
  • It allows the reader to draft their own opinion on whether a COI exists and what significant association it has with the study.
  • Readers and editors easily recognize that several nonfinancial forms of bias, may it be executive, cognitive, competition at academic level, or discriminatory based on personal confront can affect a study or the reviews.

Over the past few decades, only the financial disclosure has emerged as an attainable goal among the above stated, but the process has not been perfected either in concept or practice.

The financial disclosure remains a debatable topic in field of medicine with some finding the requested reporting burdensome and others still unsatisfied that declaration is pellucid, at its best.

Turacoz Healthcare Solutions, a medical communication company providing medical writing services, understands the significance of financial disclosures in medical publishing.

Turacoz provides services like scientific writing, publication writing, regulatory writing, clinical trial writing support, pharmacovigilance support, etc.

To know more about the services and to seek help, you can write us at [email protected]

New Drugs For HIV: Making An Impact On HIV Treatment

The global statistics for HIV/AIDS 2017 have revealed that around 37 million people across the globe were affected by HIV, out of which 1.8 million were children. 1.8 million new cases of HIV were registered in 2017, making it about 5,000 new cases per day.

Around 75% of the total people affected by HIV were aware of their condition, whereas the rest 25% were yet to be examined. HIV screening is very important and crucial for its prevention and treatment. 21.7 million HIV positive people, globally, were having the access to antiretroviral therapy (ART).

Though the deaths due to AIDS have been reduced by 51 %, globally, there is still a lot to be done for this condition. Till date, we have no cure for HIV. There are various advancements in the drugs for HIV treatment, but there hasn’t anything been invented yet that can cure HIV forever. In such a case, every new drug invented and approved is a ray of hope for many HIV patients worldwide.

New drugs approval for HIV:

Recently, the US Food and Drug Administration gave its approval to two new drugs developed for treating HIV-1, the most common form of the virus.

Over the decades, this disease has been researched upon and understood by various scientists and efforts have been made to find treatment for the same. This approval signifies the potential and improvement in the treatment of the ailment and states that the options for treating the condition have now increased.

Known drug manufacturer, Merck, announced that FDA have approved the two new antiretroviral drugs- Delstrigo & Pifeltro.

These oral medications are targeted toward those adult HIV patients who have not been exposed to antiretroviral treatments before. These medications aren’t meant for the patients who have been previously receiving the antiretroviral treatments.

The approval for these drugs was granted posted the successful phase 3 clinical trial of these 2 drugs. The trial involved 700 participants for each drug. Both the medicines had same side effect of reducing the cholesterol levels.

People with HIV are now living longer life and with the recent statistics it can be inferred that very soon HIV positive people will live longer than 50 years. In such situation they are most likely to be exposed to issues like high cholesterol. So, in such conditions, the side effects of these drugs can prove beneficial as they lower down the cholesterol.

No single drug is effective for HIV patients. So, people who are looking forward to these drugs must consult their doctor beforehand to figure out the most suited treatment for them.

Choosing a certain drug or treatment regimen depends highly on various factors such as other medical issues faced by the patient, possible side effects and drug interactions. As more and more drug being available for the treatment, customized treatments can be generated keeping in mind patient’s condition.

The complexity of HIV/AIDS is still highly misunderstood by people in general and a lot is yet to be done in treatment of HIV.

Turacoz Healthcare Solutions hopes that more and even better drugs will be manufactured in near future which will make a positive impact on the treatment of HIV/AIDS and hopes that the new drugs manufactured will help in treating HIV and benefit HIV positive people.

Being a medical communication company, Turacoz wishes for HIV positive people to live a long and healthy life. Turacoz offers medical writing services like clinical trial support, pharmacovigilance support, regulatory writing, etc. and is updated on the recent advancements in the treatment of various diseases.

To know more, write us at [email protected]

Myths about HIV/AIDS: Busted

Ever since HIV/AIDS is discovered, there have been lots of rumors surrounding it. This article aims at busting those myths and presenting the fact.

HIV-Human Immunodeficiency Virus attacks the immune system of human body and makes a person weaker and increases his disability to fight against diseases. This is caused by having unprotected sex with a HIV positive person and using shared needles/syringes for injecting drugs.

There are various myths about HIV. Let’s have a look at them and then get aware of the reality:

  • You can get HIV by being around a HIV positive individual: This is the most popular rumor surrounding this situation, that you can get affected by HIV by staying around a person who suffers from this disease.

Fact: You cannot get affected by HIV by shaking hands, touching, hugging, kissing or sitting together with a HIV positive person. The HIV virus transfers to your body through vaginal fluids, semen and blood of a HIV positive person.

  • HIV is caused by mosquito and insect bites: Another popular myth which says that if a mosquito bites a HIV positive person and bites you too, then you can also get HIV.

Fact: One cannot get HIV from any mosquito or insect bites. Mosquitoes never inject blood in your body, not does any other insect.

  • You cannot live long, if diagnosed with HIV: A common misconception is that if you have HIV than your life is cut-short or say is over. You will die soon.

Fact: HIV does not mean that your life is over. When it came into knowledge, there were any deaths due to it because there was nothing that we knew about this disease. But today, a lot is known about it. Though there is no fix cure for this, but still, there are certain treatments and therapies that help control the damage HIV does to your body. If one follows proper therapy and takes daily doses, one can live a normal, healthy and long life.

  • Having sex with a HIV positive person will get you HIV: Another myth, that says, if you become physically intimate with a person who is HIV positive, you can also get affected by the virus.

Fact: It is very important to understand that how HIV spreads, what are the risk factors and the preventative measures. By using quality condoms, you can lower down the risk of transmission of this virus. Practicing safe sex is the key to stay away from getting infected with this virus.

  • A woman affected by HIV will pass it on to her baby: This myth states that a HIV positive woman will pass on this virus to her baby during pregnancy and the baby with be HIV positive too.

Fact: This can only be possible in the case where no proper measures are taken to prevent the baby from the virus. A HIV positive woman can prevent her baby from getting infected by taking proper treatments at the right time. There are some treatments available that ensure safer deliver of child and keep him/her virus-free.

  • There is no need for condom if you use HIV Prevention Pill: A myth that says, one does not need to use condoms if he/she is taking a PrEP.

Fact: PrEP (HIV pre-exposure prophylaxis) is a technique through which the use of a regular antiretroviral pills can lower down the risk of getting infected by HIV by as much as 92%. But this does not state that the condoms should not be used at all. It is always good to stay on the safer side.

  • One can stop using condoms if he has an undetectable virus: A myth that says if you have suppressed your viruses to an undetectable level, you should quit using condoms.

Fact: It is true to a certain extent that a person who has suppressed his viruses completely such that they become undetectable, is less likely to transmit the virus. But this doesn’t ensure that there aren’t any factors that can increase or reduce the risk individually.

  • We are on the verge of curing HIV/AIDS: Another false claim that the cure for HIV is about to be discovered.

Fact: There are numerous researches going on and a lot has been understood on this disease. Advances are being made but we are not yet close to disclosing the cure for it. Till date, this disease has no permanent cure and only certain drugs are available which can help control the damage.

  • Straight men and the ones who do not take IV drugs cannot get HIV: Misconception that only gays can get affected by this virus called HIV.

Fact: Though men involved in homosexual sex are more likely to develop HIV, heterosexual contact can also get you affected. Around 3 in 4 women and 1 out of 6 men have this situation.

  • You cannot have children if you’re HIV positive: A very common misconception stating that a HIV positive cannot conceive and extend family.

Fact: It is not necessary that you will not be able to have children if HIV positive. There are certain ways and treatments that can help you conceive. Though HIV is a sexually transmitted disease, there are various options you can consider for conceiving, depending on which partner is HIV positive.

Turacoz Healthcare Solutions aims at spreading awareness regarding HIV/AIDS and debunk any myths or misconceptions surrounding it and make people understand the reality.

Turacoz is a medical communication company and provide services like medical writing, regulatory writing, publication writing,  pharmacovigilance, etc. So, being related to pharma industry, we believe in raising awareness among masses for certain diseases and help them in knowing the truth.

To avail our services or for any query or help, you can contact us at:

[email protected]

It’s about the Blue Circle: Diabetes, its types and challenges

Not everything sugar is good for you! The overdose of sweetness in your life can be fatal as the threat called ‘Diabetes’ is hovering over the head of millions of people around the globe. It has emerged as the leading cause of blindness, kidney failure and lower limb amputations, globally.

The worldwide commonness of diabetes among grown-ups of the age 18 years and above has ascended from 4.7% in 1980 to 8.5% out of 2014, i.e. 108 million to 422 million.

In 2016, an expected 1.6 million deaths were straightforwardly caused by diabetes. Another 2.2 million deaths were inferable from high blood glucose in 2012. As per WHO estimates, diabetes was the 7th prominent cause of deaths in 2016. Diabetes has been prevalent in the middle and low-income nations.

When talking about Asian countries, India accounts for the most number of diabetic people. As per WHO, India is on the top of the list of the countries with highest number of diabetic people. Currently India represents 49% of world’s diabetic population, with around 72 million cases in 2017 and this figure is expected to rise by more than double by the next decade.

A month dedicated to Diabetes:

The month of November is observed as Diabetes month and November 14th of every year is celebrated as World Diabetes Day in order to raise awareness about Type 1 and Type 2 diabetes, considering the gravity of the ailment.

The theme for the year 2018-2019 is “The Family and Diabetes”.

We all have come across a pink ribbon for breast cancer awareness, a red ribbon for AIDS awareness, etc. The World diabetes is denoted by a Big Blue O.

The blue colour is intended to summon the shade of the sky, and the circle is an image of solidarity. This symbol thus stands for “unite for diabetes”.

What is diabetes?

Diabetes is a critical, long lasting condition where your blood glucose level is extreme. It is chronic disease in which he pancreas either are unable to produce insulin or the body is not able to efficiently use the insulin formed.

Be it any type of diabetes, it holds one thing in common which is that they cause the patients to form extreme level of glucose (sugar) in their blood. It is true that the human body needs glucose as it is the source of energy but excessive formation of it is not good for the body.

Glucose is formed when our body breaks down the carbohydrates which we consume in form of solids or liquids and this glucose is then diffused to the blood. A hormone named ‘Insulin’, secreted by pancreas, helps the glucose in the blood to enter the cells and provide us energy.

A non-diabetic person’s pancreas realizes when the glucose enters the blood and eventually releases the right amount of insulin helping the glucose to enter the cells. This whole process doesn’t function properly in a person affected by diabetes.

The 2 main type of diabetes are: Type 1 and Type 2. They’re diverse conditions, yet they both are serious.

Type 1 and type 2 diabetes:

People with Type 1 diabetes are not capable of making insulin, but the case differs for the person with Type 2 diabetes. The person with latter form of diabetes has either insufficient amount of insulin produced, or the insulin formed doesn’t work effectively. Around 90-95% of a diabetic cases accounts for Type 2 diabetes.

In both types of diabetes, the glucose is unable to enter the cells and thus start accumulating into blood, causing various health issues such as heart problems, issues with eyesight, adverse effect on kidneys, etc.

Symptoms of Type 1 diabetes:

  • Polyuria (increased frequency of urination)
  • Feeling excessively thirsty (polydipsia)
  • Frequent hunger
  • Weight loss
  • Changes in eyesight
  • Tiredness

Symptoms of Type 2 diabetes:

These are almost similar to the Type 1 diabetes but may remain undiagnosed in initial or early stage and hence the complications arise.

Other rare types of diabetes are:

  • Maturity onset diabetes of the young (MODY): A rare types of diabetes that runs in family and is caused by a change or mutation in a single gene. So if any parent has this mutation, there are 50% chances that their child will inherit it from them and even can develop it before the age of 25 irrespective of their weight, lifestyle, etc.
  • Neonatal diabetes: It is spotted under the age of 6 months. In it the mutation of genes affects the insulin formation resulting in a high blood glucose level. Around 20% of people affected by this have developmental delay or epilepsy. It’s different from Type 1 diabetes on the point that Type 1 doesn’t affect a person below the age group of 6 months.
  • Wolfram syndrome: A rare type of genetic disorder which is also acknowledged as DIDMOAD syndrome, pertaining to its 4 common features (Diabetes Insipidus, Diabetes Mellitus, Optic Atrophy & Deafness).
  • Alstrom syndrome: It is also a rare genetically inherited condition which has features like Retinal decay, loss of hearing capacity, obesity, kidney failure, rheumatic problems, etc.

People suffering with Type 2 diabetes have quite a few issues when monitoring their health, like:

  • Monitoring their blood sugar level at regular intervals, throughout the day.
  • Consuming a diabetic-friendly diet
  • Exercising on daily basis to stay fit and maintain weight.
  • Taking the daily dose of medications.
  • Frequently visiting the doctor for check-ups.

What makes this a tedious task is that only 1% of diabetic people’s time is spent under the guidance of a healthcare expert, rest 99% are managing it on their own. Self-management is the toughest form of management.

Adhering to a strict and healthy diet becomes quite a difficult task for people today, considering their hectic life schedule.

The most crucial aspect in case of diabetes is early diagnosis. The prediabetes is very important in determining the factors related to Type 2 diabetes. When talking about the challenges in diabetes diagnosis, the awareness of the disease is the most crucial part. The prediabetes stage is the phase when one needs to get alert in order to avoid further complications in diabetes and reach out for early and timely diagnosis.

What is prediabetes?

It is concerned with the pre-diagnosis of diabetes. It is basically a warning signal for a person whose blood sugar level is higher than normal. Though it is not considered as diabetes, but still implementing a healthy lifestyle from thereon can help reduce the risk of forming Type 2 diabetes later.

By adapting a healthy lifestyle, eating healthy and exercising daily and maintaining a healthy weight can prevent prediabetes from converting into diabetes.

Prediabetes strikes when your body starts encountering trouble with the use of insulin. It is yet not clear as to what causes the insulin process to go astray in some people.

Here are the risk factors that contribute to the development of prediabetes:

  • Weight issues: Being overweight i.e. having a BMI more than 25 can result in prediabetes.
  • Absence of exercise: Not doing any form of physical activity can result into mismanagement of weight and leading to problem like obesity which is the root cause of prediabetes.
  • Family history: If someone in your close blood relation or a family member near to you has diabetes, then you are likely to develop it too, as it is hereditary in nature.
  • Age: Getting older has its own set of cons and one such is the risk of developing diabetes. People with age 45 & above can expect to be at the risk of prediabetes and post 65, this risk increases even more.
  • Other health issues: People with high blood pressure/hypertension are at the risk of getting type 2 diabetes.
  • PCOS: In women, PCOS (Polycystic Ovarian Syndrome), wherein multiple cysts get formed into ovaries, increases the risk of developing prediabetes as one cause for these cysts can be insulin resistance.
  • Gestational diabetes: If a woman has developed diabetes during the pregnancy, there are higher chances of developing prediabetes in the long run.

Challenges in health management during diabetes:

  • Absence of disease arbitration for pre-diabetics: As per American Diabetes Association, the predominance of diabetes has hiked up by 40%, during the last decade. Without any mediation, these numbers will constantly rise in the coming years. 1 in every 3 adults is suffering from prediabetes, but dismally only 7-10% are informed of it. In the absence of intervention, around 30% of such people will fall prey to Type 2 diabetes in a time-span of 3 years.
  • Cohesion with medication: Diabetic people juggle between the costs, avenues, competing arrangements and absence of awareness when they struggling to adhere to the medication.
  • Expensive treatments: The treatment expenses for diabetes are really high. The minimum cost care is impediment, early diagnosis and treatment soon after to minimize the chances of any complications.
  • Inclusion for meds and supplies associated with diabetes: The patients today bear a huge responsibility towards their healthcare costs. Along with the payment of rising insurance premiums, they also have to cope-up with the extra costs of co-pays, co-insurance, etc.

Every problem comes with a solution and so is the case with diabetes. Here are the solutions for the complexities of diabetes management:

  • As mentioned, that early diagnosis is very crucial, staying alert and vigilant about the early symptoms is very important which helps in early detection of diabetes. Symptoms like excessive hunger and urination, excessive thirst, fatigueness, etc. are to be watched out for and in case of any doubt consulting with the physician will help in the diagnostics of prediabetes.
  • A fasting plasma glucose test is used to detect diabetes (126 mg/dl & more) or prediabetes (100mg/dl-125mg/dl) and provides with the measurement of blood glucose, post eating for a minimum of 8 hours.
  • Oral Glucose Tolerance is used to measure blood sugar, post 8 hours of eating anything and post 2 hours of drinking glucose drink. It tests diabetes (200mg/dl & above) and prediabetes (140mg/dl-199mg/dl).
  • There is a random plasma glucose test which in conducted test blood sugar irrespective of when the food is consumed. With particular symptoms like excessive urination, hunger or thirst and weight loss, etc., values of 200mg/dl or more is tested.

Type 1 diabetes is diagnosed earlier as compared to Type 2 diabetes as the symptoms are quite evident and it requires immediate medical care. In case of Type 2 diabetes, the symptoms are too mild to be detected early and can go unnoticed for 7-10 years, inviting more complications and greater health risks.

Now it is about the lifestyle choices that you make. The sedentary lifestyle which people lead today has given birth to various health issues, diabetes being the main. Try to live a more active and healthy lifestyle to prevent yourself against this disease. Healthy eating and healthy living is the key to a healthy life. Being aware regarding the disease can help reduce the risk of its development.

Turacoz Healthcare Solutions-a medical communications company, understands the complexity of diabetes and acknowledges that the hectic schedule of the corporate has fuelled the condition. Turacoz practices a healthy working style for its employees. Practicing desktop yoga, eating healthy and taking breaks in-between work is the culture practiced here. Turacoz values its employees and understands the fact that ‘health is wealth’ and is constantly working towards making work-life healthier for the employees and practicing a active and healthy living style.

Turacoz follows a ‘NO-STRESS’ policy for its employees and believes in keeping the work environment friendly and healthier to avoid any work or workstation related stress and pressure, as stress is also a key factor in triggering diabetes among people.

“Healthy living, healthy eating and healthy working are the mantra for Turacoz Healthcare Solutions”.

 

 

Significance of Publication Planning

Publication planning is that part of the pharmaceutical landscape that ensures that data from pharma companies (clinical trials, commentaries on drug/device class, and other publications supporting the efficacy of drug/device) is disseminated through medical journal articles–an important aspect of pharma companies’ overall marketing strategy. To publish a mix of editorials, primary and secondary publication, and review papers is the goal of efficient publication planning. Strategic publication planning can maximize product visibility throughout its life cycle. The launch of new drug/device in the market can be successful if the key clinical messages reach the target audience at the right time, for which publication planning is essential. The most successful drugs launched in the last 10-15 years have ridden on the back of a very well-implemented publication strategies. Overall, publication planning aids in the accurate reporting of scientific research, thereby promoting ethical transparency at every stage of medical research through the involvement of investigators, journal editors, and publication professionals.

An effective publication planning team is the key to an efficient publication plan. It is the publication planning team that creates a proactive plan to deliver client‑focused solutions and enable strategic planning and timely implementation of the publication plan. The first step in a publication plan is a “GAP analysis”, which can identify gaps in the literature. Thereafter, the team does an analysis of strengths, weaknesses, opportunities, and threats (SWOT) comprising product strengths, weaknesses, market opportunities, and market threats to understand which areas need maximum focus during implementation of the publication plan. For example, if the product in question has more safety issues compared to its competitors, then the publications would mostly be aimed to showcase that the safety concerns are unfounded. The publication planning team also analyzes the Health Economics and Outcomes Research (HEOR) related to the product and various competitors available in the market. In addition, it is the responsibility of the publication planning team to discuss issues related to authorship and data interpretation, and to ensure all the professionals involved in the publication process meet scientific and ethical standards. A good publication planner gets the best key opinion leaders (KOLs), study investigators, and a publication agency (if needed) to write the papers. This allows authors to concentrate only on scientific discussion, and not on logistical issues. Moreover, it encourages transparent communication between researchers and contributors.

There are also a few ethical issues that the publication planning team needs to deal with. These are shown in Figure 1.

Figure 1: Ethical issues relating to publication planning

Apart from ethical considerations the publication strategy team should know the audience; whether they intend to reach out to primary-care physicians, specialists, allied health specialists, managed care specialists, hospital pharmacists, retail pharmacists, formulary managers, and calibrate their publication plan accordingly. Based on this, they should select the journals for publication. Although publishing in a top-tier journals is prestigious, and adds substantially to a product’s first impression, it should be balanced against the length of time to publication. Prestige cannot make up for a publication that arrives too late. Early publication planning helps to ensure both goals are achieved. Finally, ensuring that a publication coincides with important meetings is an important part of efficient publication planning. This can ensure that the medical representatives at these scientific meetings have evidence to back their claims regarding the drugs/devices they are promoting.

With new guidelines such as GPP3 in place, there is an increased scrutiny on publication planning. Therefore, understanding good publication practices for providing structure and ethical implementation of the publication plan are important.

Turacoz Healthcare Solutions (THS), a medical communication company, offers services to healthcare professionals in clinical research, regulatory writing, medico marketing writing, publication writing and support for conducting medical advisory board meetings. Turacoz understands the importance of a good publication which is in line with the new GPP3 guidelines. We follow the same updated guidelines for all our publications and comply with all legal, ethical and regulatory requirements. To know more about our specialization, please do visit our services section.

Are you at the risk of Breast Cancer? Read this & find out.

Breast cancer is the most prevalent form of cancer in women. Though it also affects men, the incidence rate is quite low. Early detection (be it any type of cancer) increases the chances of survival in case of this deadly ailment.

For better and timely diagnosis, it is very important to detect the early signs of breast cancer. In this blog we will be discussing the signs of breast cancer.

Have you ever paid attention to your breasts?

How often do you check your breasts?

Ever noticed anything unusual around that area?

These questions are very crucial when it comes to determining the signs and symptoms of breast cancer. Start with having a look carefully at your breasts.

How to check your breasts?

You don’t need any special training to check your breasts. Each woman has a different set of breasts and you should know how your breasts normally feel like or look like. When you know this, you will easily be able to spot anything unusual in your breast area.

Check the whole area around your breast including your armpits & upper chest and if you notice anything unusual, get yourself checked by a doctor.

What to check?

Check for any lumps around your breast area, upper chest or even around armpits. Lumps can be the primary symptom of breast cancer. Pain in breast can also be a sign of breast cancer but usually it is not in most cases. Pain in your breast can be due to other reasons as well but if an unexplained pain prevails over some time, it is advisable to get it checked by a doctor.

Checking your breasts for any signs of breast cancer follows a simple formula: TLC: Touch, Look, Check

  • Lumps are not visible, but they can be felt. Look for any lump or swelling in your breast, armpits and upper chest.
  • Check for any changes in shape or texture of your breasts. A change in size or shape of your breasts might be an indicator of something fishy, for instance one breast appearing larger than the other one.
  • Have a look closely at the texture of your breasts. Look for any puckering or dimpling of the breast skin.
  • Closely examine the color of the breasts. If you notice any redness or inflammation on your breasts, get it checked by a doctor.
  • Notice whether your nipples look different than usual. A change like inversion of one of the nipples if present (these are usually pointed outwards), then consult a doctor.
  • If there is any unusual discharge from your nipples, immediate action is required.
  • Check for any rashes or crusting on your nipples or the areas nearby.

If you notice any of the above symptoms (also presented in Figure 1), then go and see a doctor. It is not necessary that having any of these symptoms is the sign of breast cancer, but it is always safe to have a breast screening post consulting with a doctor. Doctor would examine and if further check-ups required, he will refer you to the specialists accordingly.

Are you at the risk of Breast Cancer? Read this & find out.

Figure 1: Symptoms of breast cancer in women

Do you need to check your breasts often?

Well, as a precautionary step or rather say to be on the safer side and to be aware of this disease you can check your breasts at regular intervals. You can check them monthly or bi-monthly or how often you feel like.

Once you start checking them regularly you will be able to identify even the slightest change taking place in them, be it due to age or at various times of a month. Your breasts can feel sore or heavy before or during your periods, heavier and bigger during pregnancy and you might notice this change if you know your breasts well.

In the similar way if anything is odd with them, it would be noticeable when you are aware of the normal/usual appearance of your breasts.

Breast cancer in men:

Men also have breast tissue, but they are very much less developed as compared to the ones of women. This is also the reason why breast cancer in men is a rare phenomenon.

But, still, we cannot feign ignorance to the fact that men too, are affected by breast cancer.

 

Signs & symptoms of breast cancer in men:

If someone in your family had breast cancer, you have some chances of getting it, but again it’s not definite that you will. Regularly checking your breast is a wise option especially if you have a genetic record of Klinefelter’s Syndrome (history of breast cancer in family).

The breast tissues in men are mostly behind the nipple area & the pigmented region known as areola. Breast cancer in men usually appears around the nipple area as a lump (Figure 2).

Are you at the risk of Breast Cancer? Read this & find out.

Fig. 2: (a) Shows changes in the look of the nipple or areola (direction change in nipple); (b) shows discharge from nipple or nipple ulcers; (c) Shows lump formation around nipple or armpit

If you find any of these symptoms, go and consult a doctor. In case cancer is detected, you can get an early diagnosis, ensuring better and faster recovery. If not, then, any other problem might also get solved in time.

Turacoz Healthcare Solutions requests every men & women to pay close attention to these specific parts of their body and help themselves in early detection of breast cancer, if present.

An early detection increases your chances for better treatment and recovery.

World Rabies Day: September 28th, 2018

Rabies, a viral disease that is mainly transmitted by an infected animal bite, is a 100% preventable disease. However, it is still major a public health problem with one death reported every 15 minutes worldwide. Therefore, to raise awareness regarding the burden of rabies, and to unite efforts for its prevention and control, 28th September is celebrated globally as World Rabies Day. This day also marks the anniversary of Louis Pasteur’s death, the French chemist and microbiologist, who developed the first rabies vaccine. Celebrating the World Rabies Day serves a reminder that our fight against this deadly disease is far from over.

The first World Rabies Day was observed in 2007, which was a collaboration between the Global Alliance for Rabies Control and the Centers for Disease Control and Prevention, Atlanta, USA, with the co-sponsorship of the World Health Organization (WHO), the World Organization for Animal Health (OIE) and the Pan American Health Organization. It proved to be an extremely successful campaign, and by 2009, nearly 100 million people worldwide had been educated about rabies and ~3 million dogs had been vaccinated (as estimated by the Global Alliance for Rabies Control). On the last World Rabies Day in 2017, several major health organizations, including WHO, OIE, and the Food and Agriculture Organization of the United Nations (FAO), pledged to eliminate human deaths from dog-transmitted rabies by 2030.

The World Rabies Day has been identified as an important tool that can assist in rabies prevention by educating and mobilizing at-risk communities, animal health workers, public health practitioners, governments, key opinion leaders, and experts. Today, we have safe and efficacious animal and human vaccines that can eliminate human deaths from rabies; however, lack of awareness is the major roadblock in successfully engaging communities for rabies prevention. Rabies prevention and control has two broad components: animal rabies control and human rabies prevention. Pictorial description of both are shown in Figure 1.

 

 

Figure 1          Rabies prevention and control

The World Rabies Day campaign has a centralized online platform where groups can register their World Rabies Day events and download resources, in print and online, that can support their message for rabies prevention. Moreover, since rabies is a disease that can easily cross borders, especially in wild animal populations, the campaign encourages trans‑national collaboration of rabies control and prevention. The World Rabies Day logo represents the complexity of rabies, which can infect human beings, wildlife and domestic animals, and therefore, needs an interdisciplinary approach to control it.

Overall, the World Rabies Day is a campaign for education, awareness, and action to encourage organizations across all levels-international and local-to increase the spread of messages for rabies prevention. With this blog, Turacoz Healthcare Solutions (a medical communication company) aim to raise awareness about rabies prevention and highlight progress in defeating this animal transmitted viral disease.

A guide to Alzheimer’s care: Tips for daily tasks

It is estimated that nearly 44 million people worldwide have Alzheimer’s or related dementia. The total number of people with Alzheimer’s is projected to almost double every 20 years.

What really scares me is Alzheimer’s or premature senility, losing that ability to read and enjoy and to write. And you do it, and some days maybe aren’t so good, and then some days, you really catch a wave, and it’s as good as it ever was: – Stephen King

Patience and flexibility are of most importance in Alzheimer’s patients care. Practical tips to be considered by caregivers when handling patients with Alzheimer’s are illustrated in the figure. This helps maintain a sense of independence, dignity and boost their confidence as the patient becomes dependent on caregiver for his/her daily needs.

A guide to Alzheimer’s care: Tips for daily tasks

Figure 1: Tips for caregivers’ family and friends of patient on how a person with Alzheimer’s disease should be cared.

Handling patients with Alzheimer’s disease

Caring for patients with Alzheimer’s disease is challenging, and in many instances the caregiver also falls into depression if they are not supported by friends and family. One of the major challenges a caregiver faces is the change in behaviour of the patient. Both the patient and the caregiver find it difficult to manage the daily basic activities like bathing, eating dressing etc.

  • Tackling communication challenge in Alzheimer’s Disease

Communicating with a patient with Alzheimer’s can be challenging as both understanding and being understood pose a problem. Thus, always try to communicate in simple words and short sentences, avoiding distractions. In many cases the patient finds it difficult to frame sentences to communicate. Have patience and provide them the words he/she is looking for. Give them enough time to respond.

  • Tips to reduce bathing and showering challenge in Alzheimer’s disease

Plan bathing or shower for time of the day when the patient is calm and is ready for bathing. Try to make it a routine. The patient must be made comfortable. As the patient is sensitive to temperature, test the water temperature before bath.

  • Dressing a person with Alzheimer’s disease

Try to get the patient dressed same time each day and make it a routine. Give the patient time to dress and encourage the patient to dress himself/herself.

  • Getting a Person with Alzheimer’s disease to Eat

Try to maintain familiar meal time routine. Ensure a calm, relaxed environment free of distractions during meal time. This helps to reduce confusion and anxiety of patients. Caregivers must ensure that patients are drinking enough water to avoid dehydration. Routine oral check-ups have to be done.

  • Exercises and Activities for people with Alzheimer’s disease

Always watch for agitations. Simple and easy activities which will enhance his/her skills will be more effective than teaching them something new. Exercises can improve the patients’ health and help them to sleep better.

  • Incontinence in patients with Alzheimer’s disease

This is a common problem faced by the patients as the disease progress. Limit fluids containing caffeine and other diuretics.

  • Sleep Problems for Caregivers and a Person with Alzheimer’s disease

Many patients with Alzheimer’s faces ‘sundowning syndrome’, where the patient gets agitated and irritated during bed time. Exercises and physical activity with minimized day time naps helps the patient to get a sound sleep during night.

  • Hallucinations and delusion in patients with Alzheimer’s disease

In most cases hallucination and delusions are signs of physical illness. In such situations avoid arguing with the patient and distract the patient attention to some other topics. Check whether the patient has access to any dangerous objects that can cause harm to others and the patient himself/herself.

  • Wandering: A problem for a person with Alzheimer’s disease

People with Alzheimer’s tend to wander away from their home. Always ensure that the patient carries some sort of identification. Notify local authorities in advance regarding this problem. Always try to keep the doors locked.

Turacoz is a medical communications company, providing customized and cost-effective services in regulatory writing, publication writing, medico-marketing writing, and support for conducting medical advisory board meetings.

Turacoz healthcare solutions, aims to increase awareness about Alzheimer’s disease and with this blog, provide useful tips to caregivers, family and friends of Alzheimer’s patients.

Being a Star in your Industry is a Matter of Corporate Etiquettes!

You might wonder about the title of this article, figuring out how manners can make you a star. But before we explain you how, let’s look at the story of 2 individuals, Mr. X, who is an MBA graduate with 90% and is working for a big company for 3 years. Mr. Z, who serves the same company as Mr. X but with qualifications of bachelors & work experience of only a year. Mr. X excels in terms of qualifications & experience.

Both left to meet their clients one day for some work. Mr. X went into the cabin without knocking and discovered that client was his batch-mate & seeing this he said while patting on his client’s shoulders –“Hey! Good morning. How are you doing? Long time. (flipping the file on the table) have a look at my new proposal, I bet it is awesome dude.”

Mr. Z went in after knocking and receiving a welcome gesture from his client. He recognized the client was someone he knew. He then asked for the permission to sit and spoke-“Good Morning, sir. As per the telephonic discussion, I have prepared a draft of the proposal. Kindly have a look. (handing over the file to the client)”

He then stands up, greets again and then leaves.

The client thrashed Mr. X while Mr. Z got an appreciation for his efforts.

Now you must marvel, what went so wrong with Mr. X? Well, the lack of proper business etiquettes landed Mr. X in this situation. No matter how well qualified he was and how much experience he had, he didn’t act accordingly. When into business, your personal relationships don’t signify, you must act formally.

Mr. Z though being less qualified and experienced than Mr. X, knew how to act professionally and thus strike the chord right.

So, when you are driving in a corporate set up, it signifies how you behave in the business environment.

What are Corporate Etiquettes?

These are an array of generally recognized rules for acting reasonably in a business environment. It is a way of displaying socially relevant behavior in business relationships.

Why Corporate Etiquettes?

  • It gives a positive perception of you
  • Behaving properly makes you feel confident & composed, letting you focus on your work
  • It saves your time as you don’t have to appease the individual whose sentiments you have hurt
  • It makes people around you comfortable & they would like to work with you
  • Forms an amicable environment
  • Ward offs misunderstandings to a remarkable extent

As per research organized by the American Society of Quality Control, 68% of business is cast away by corporate because of the improper attitude of employees’ while approaching expected clients.

So, you can simply infer the importance of Corporate Etiquettes now.

Basic Business Etiquettes to follow:

Being a Star in your Industry is a Matter of Corporate Etiquettes!

Here are some absolute DOs & DON’Ts in a corporate set-up:

DOs:

  • Dress properly/formally
  • Respect your fellow employees, juniors & seniors
  • Keep your workplace neat & clean
  • Be punctual, reach office on time
  • Respect the privacy of other employees
  • Take care of your tone & language

DON’Ts:

  • Never adopt a casual attitude at work
  • Don’t squeak into other’s cubicles/workstations
  • Don’t keep your phone on ringing mode
  • Don’t touch or use other people’s belongings without their permission
  • Don’t bully or make fun of fellow employees
  • Never wear flashy or exposing clothes to workplace
  • Never drink while you are at work

By following these simple tricks & tips you can shine at your workplace and be a star. Incorporate these into your daily life & see the difference. Turacoz Healthcare Solutions encourages the practice of good business etiquettes within its employees and promotes the same. Remember:

                            “Standards are not established by your proclamations, but by your routines.”

Because if you kill yourself, you’re also going to kill those who love you

Suicide has become the 3rd highest reason for deaths today in the world, notably among the age group of 15-44 years (male & female). As per the reports, there is 1 death every 40 seconds globally. The suicide rate, globally, has increased by 60% in the last 45 years. Suicide endeavors are up to 20 times more incessant than finished suicides.

This is undeniably a sad state as predominantly the youth is becoming suicidal. When you are surrounded by problems and cannot figure out a way, suicide is not the solution. But still, many people fail to understand this fact and end up taking their lives, leaving their near & dear ones in immense pain, shock & trauma.

The world celebrates “World Suicide Prevention Day” on 10th September to spread awareness about suicide & offer worldwide commitment & action to prevent suicides.

The theme for 2018 is “Working together to prevent suicide.”

There are various reasons for suicide, to name some:

  • Unemployment
  • Losing a loved one
  • Family problems
  • Financial issues
  • Alienation from community, society or any group
  • Mental disorders like depression, substance abuse, etc.

As per a survey, mental states like depression account for most suicides in the world, about 90%.

According to the reports by WHO:

  • The Eastern European region has the highest suicide rate for both the genders.
  • India & China contribute to 30% of total suicides worldwide.
  • 55% of people aged between 15-44 years & 45% aged 45 or above commit suicide.
  • Suicide among the youth is becoming a major reason for concern.

Suicide in India:

A land of over 1.32 billion people has a suicide rate of 16.4 per 100,000 women (6th highest globally) & 25.8 for men (22nd highest in the world), according to WHO. The major causes are identified as family issues, prolonged illness & any mental disorder. People in the age group of 15-44 had the highest number of suicides.

Turacoz Healthcare Solutions understands the severity of the problem and presents some tips to help a suicidal person.

First, let’s get ourselves clear about common misconceptions about suicide:

  • Individuals who discuss suicide won’t usually do it
  • Any individual who tries to kill him/herself must be insane
  • In the event that a man is resolved to murder him/herself, nothing will stop them
  • Individuals who committed suicide were individuals unwilling to have looked for help
  • Discussing suicide may give somebody the thought

If you pay attention, then anyone who is about to attempt a suicide or is having suicidal thoughts, won’t commit it abruptly. He/she will drop some or the other hint. Being alert & noticing the hints can aid in preventing the suicide

Below mentioned are some hints that a person thinking of suicide might drop:

  • Discussing suicide
  • Searching out deadly means like pills, gun, etc.
  • Distraction with death
  • No expectation for what’s to come
  • Self-hatred, self-loathing
  • Getting undertakings all together like making a will, etc.
  • Saying farewell
  • Pulling back from others
  • Causing harm to themselves
  • A sudden feeling of quiet

Preventing the suicide:

Because if you kill yourself, you’re also going to kill those who love you

  • Speak up to the individual whom you are really concerned about. If you think he/she is having suicidal intentions, you, being the individual to share the sentiments with might make him feel comfortable and by talking, you will also get an idea of his mental state and judge the gravity of the situation.
  • Respond promptly in a deadlock. Once you have analyzed the urgency of the situation and sensed the degree of the threat, respond accordingly. Call emergency services, remove any hazardous material or weapons & make sure to stick with the person about to commit suicide.
  • Extend your support & sympathy. Lay an ear to the person and hear out all he/she has to say. Comfort the individual and try to console him/her. Show your faith in him/her and make the person believe that they are much needed here and are loved and cared for.

To help a suicidal person you should:

  • Reach out for professional help
  • Have a follow-up on the treatment
  • Raise the person’s morale & encourage a healthy lifestyle for him
  • Keep the person distant from any measures of suicide
  • Keep supporting and caring

There are various Suicide helplines you can reach out to even if you are the person concerned or the victim itself. Below are the list & details of a few 24/7 suicide helplines for India:

  1. AASRA: +91 22-27546669/ +91 22-27546667

      Email: [email protected]

  1. 1life: +91 78930-78930

      Email: [email protected]

  1. Vandrevala Foundation: 1860-266-2345/ 1800-233-3330

      Email: [email protected]

Suicide is an issue that needs to be taken care of immediately. Your support and love for such people can make them love their life again. The individuals suffering from suicidal thoughts don’t want to die; they want their pain to die. We can help them with ending their suffering or at least make them forget their misery and live again.

To all those people who are thinking of ending their existence, Turacoz wants to convey to them the message that-

“You are not alone. Everyone feels lonely at some stage in his or her life. But this feeling is momentary and will not last forever. The world is a predominant place with you in it. Love yourself!”

Art of Effective Team Management

Managing a team to success requires more than just simply assigning tasks to individuals. Handling a team can be exciting, rewarding and exhausting. Being responsible for a team of people you have never met before and then being accountable for their development, achievements, and performance can be little petrifying.

So, what does it take to manage the team effectively? Good Leadership! Yes, for effective team management to work, it needs good leadership. A manager must work upon to strengthen the bonds between the individuals in their team and must possess good management skills.

We often hear the terms ‘leader’ and ‘manager’ used inclusively, but there is actually a difference. By definition, a leader is someone who creates the vision, innovates, and focuses on the long-term overview, and a manager is the person who gathers the necessary tools and resources to set, measure, and accomplish the vision. The leader is the one with the people skills, whereas the manager focuses on systems and structures. But away with that — we all know that for a manager to stand out, having leadership qualities is a must.

Being able to communicate well and develop a relationship with all the members of the team is critical for building trust, promoting collaboration, and enhancing teamwork. A team who enjoy working together, is more likely to succeed together.

Here are some tips for achieving a happier and more productive team:

  1. Being transparent: Transparent working environments have been found to make teams more accountable, happy and creative. Transparent work environments help to develop a feeling of mutual respect between team members and team leaders.
  2. Keep communicating: The foundation of a cooperative and productive team is good communication. Open and consistent communication at workplace helps employees to feel secure in their positions. In turn, team members feel freer to contribute ideas and suggestions, enhancing creativity.
  3. Constant feedback: Providing feedback to team members is one of the best ways you can support them to develop professionally and personally. Feedback can be difficult, but it is an essential part of effective team management.
  4. Encourage collaboration: Team members feel happy if they can get along well with one another & can perform better too.
  5. Trust your team to do their job: Effective team management shouldn’t mean micro-management. Leaving your team to do their job without you constantly hovering over their shoulder will not only highlight your confidence in them to do a good job, but it will also give you time to complete your own tasks — a win-win for everyone really.
  6. Recognize achievements: If someone’s doing a good job, acknowledge it. Recognizing efforts illustrates to your team that you are paying attention to them, and that you appreciate their hard work.
  7. Foster development: Encouraging employees to acquire new or advanced skills, knowledge, viewpoints and ensure that the team members are happy in their roles are crucial factor for the overall growth of business.

Turacoz Healthcare Solutions takes pride in having very effective and efficient team managers who understands the need and expectation of the team members. We believe in supporting all our employees in every way possible. We are a listening organization and continuously working in the lines of perfecting our teams. To work with us please do visit career section.

Healthcare Advertising

“Are you into healthcare advertising?”

“Yes!”

“Oh! It involves so much medical jargon, and little opportunity for creativity! Do you enjoy your job?”

I have been part of several such conversations, and through this blog, I would like to touch upon some facets of healthcare advertising that may partly undermine (and partly reinforce!) the stereotypes associated with this field.

Based on data from a 2015 US-based study, nearly $10 billion is spent by the healthcare industry into advertising and marketing. Despite the huge amount of money involved, the healthcare advertising segment is often typecast as “lacking in creativity/innovation” and “boring”. Well, this is not surprising considering that every print, website, banner, and video advertisement gets scrutinized by a medical review team and needs to pass a rigorous risk mitigation assessment. In fact, dissemination of safety information takes up almost half of a 30 second TV spot and rules for short-form messaging may run up to 10-15 pages. With such extensive regulations in place, it is often difficult to be creative! Most advertising professionals, therefore, create campaigns that are safe and obvious to avoid getting caught in the legalities of the system.

In addition, creating advertisements from data provided by doctors, is quite challenging. The key is to understand the underlying motivation behind the drug/campaign from an emotional perspective, including purchasing decisions and consumer behavior.

Future of healthcare advertising

How can healthcare advertising evolve in the near future? Here are a few pointers:
1)  Optimizing advertisements for mobile phones (smartphones) and using social media apps, such as Facebook and Twitter, as marketing platforms
2)  Developing smart (read: social-media shareworthy) content that is interesting, fresh, reliable, and authoritative
3)  Individualizing marketing delivery systems using digital marketing tools: Contemporary marketing methods identify user interests and deliver timely, personalized and relevant content on a one-to-one basis
4) Target patients by location: Such a strategy can adapt the advertisement according to social and personal preference of the audience, and also inform them about nearby facilities
5)  Going live! “Programmatic video” is the new buzzword in the field, and according to some estimates, it will account for the majority of digital video spending over the next couple of years. Programmatic video basically uses real time data and presents video advertisements to precisely qualified customers at exactly the right time.

Overall, it can be concluded that healthcare advertising may not be as creative as the fast-moving consumer goods (FMCG) segment; however, the challenges it poses make it all the more interesting to work in this field. With the evolution of new marketing strategies, the constraints of healthcare advertising can prove to be an asset in a non-conventional marketing set-up of the future.

Turacoz Healthcare Solutions provides high quality end to end scientific/medical writing support to the industry and academia. We expertise in different kinds of medicomarketing solutions like leave behind literature (LBL), slide-decks, posters, newsletters, patient education materials, customized books/booklets, visual aids etc. Turacoz strongly follows good marketing practices backing every product claim with scientific relevance and ensuring that the message rightly resonates with the target audience.

Breastfeeding & Love: How they are the same?

With the World Breastfeeding Week (1st Aug-7th Aug) towards its wrap for the year 2018, Turacoz Healthcare Solutions brings to you a beautiful story we received from one of the amazing mothers. The narrative is as expressed by her:

I became mother for the first time. It is a feeling I cannot explain. Being a mother is what completes a woman and my baby gave me that feeling of completeness.

3rd April 2018, the day my baby boy was born, is the happiest day of my life. I have been waiting to meet him for so long. During my pregnancy, I took care of everything and learned about the most important aspect of being a mother, Breastfeeding.

After Ansh (my boy) was born, I breastfed him. He is 4 months old now and I make sure to exclusively breastfeed him. I am aware of all the benefits of breastfeeding and want to deliver the best to my baby.

At first, I struggled a lot with it, as my nipples would hurt a lot when he latched onto them, but slowly it began to settle. Never once in mind, this thought of giving up breastfeeding occurred to me. I knew this is the best thing I can give to my baby as his mother.
I had sore nipples and cracks on them in the beginning and I was worried all the time whether he is receiving enough milk or not. But doctors told me that I would settle down with time and so will the baby. I decided to forget about the pain and discomfort and focus on feeding my baby, which he needed the most. Despite the discomfort, I fed him for 30 minutes every 2-3 hours in a day.

Today my baby is all healthy and naughty. The expressions on his face while he is being breastfed are so satisfying to me that I will go to any extent of pain or discomfort to make him happy.

This is my request to all mothers who hesitate in breastfeeding their baby, that, you should not keep your baby away from this wonderful gift. It not only gives your baby the strength and nutrients he needs but also is beneficial for you and completes you as a mother.

This is so right!

Breastfeeding is important for both babies and mothers. Here is why:

For babies:

  • It provides the best nutrition to the babies: this is what they need at least for the first 6 months of their life. Ideally, breastfeeding is recommended for a year, meanwhile, your baby can try different foods.
  • Breast milk is the source of essential antibodies: it gives babies the immunity to fight against bacteria & viruses. Colostrum, the first milk of a mother is very important for the baby and helps the most to build up the immune system. It contains immunoglobulin A, which enhances the immunity.
  • Breast milk helps in minimizing the risk of diseases: if a baby is exclusively breastfed, the chances of him/her being ill gets low. It gives the baby the strength he/she requires to stay healthy.
  • It reduces the risk of obesity: if you are exclusively breastfeeding the baby, it helps in reducing the risk of childhood obesity and helps in gaining weight healthily.

For mothers:

  • Breastfeeding can help you reduce weight: every mother puts on weight during pregnancy. Many studies have proven that breastfeeding helps you shed the extra weight off your body. For the initial 3 months, mothers who breastfeed may lose weight as compared to the mothers who don’t breastfeed.
  • Breastfeeding stimulates the contraction of the uterus: during pregnancy, the uterus expands a lot and post-delivery it goes through a process known as involution, which assists in returning the uterus to its normal size. It happens due to a hormone Oxytocin released during the pregnancy. The mothers who breastfeed have faster uterus contraction.
  • Breastfeeding lowers the risk of post-partum depression: many mothers suffer from post-partum depression which occurs shortly after delivery. Mothers who breastfeed have a lower risk of suffering from this condition.
  • Breastfeeding prevents you against diseases: breastfeeding can save you against deadly disease like breast & ovarian cancer.
  • Breastfeeding helps restrict menstruation: it provides a halt to ovulation process for some time thus preventing you from menstruating. This acts as a natural birth control.

Breastfeeding is nothing but the love you can give to your baby. Don’t hesitate or restrict yourself from loving your baby. The other name for breastfeeding is surely LOVE.

Turacoz Healthcare Solutions (a medical communication company) support and encourages exclusive breastfeeding to newborns in their first six months.

Health Economics and Outcome Research

Health economics and outcomes research (HEOR) activities comprise of Pharmacoeconomics (PE) research and health technology assessment (HTA) activities. Health economics (HE) is applied to analyze the economic aspects of health and healthcare, with focus on the costs and consequences of healthcare interventions.

PE, a sub-discipline of HE, provides a comparative value assessment between two pharmaceutical products or treatment mix. Outcome research (OR) helps in evaluating the effect of healthcare interventions on patient-related clinical, humanistic, and economic outcomes.

Thus, HEOR is a discipline that helps the stakeholders to fully understand the product value and its potential in real-world clinical practice. In healthcare industry, the stakeholders and payer rely on HEOR to gain market access and remain competitive. For this, pharmaceutical and medical technology manufactures provide clinical development information (i.e. efficacy, safety and quality) and economic evidences to guide decision makers regarding patient access to specific drugs and services. These evidences help in determining whether the treatment is effective in the populations they serve.

Sources of HEOR Evidence

To generate outcomes to monitor and evaluate healthcare services, we need to collect evidences from different sources which can be further used for decision-making processes. These evidences can be collected from different sources as shown in Figure 1:

Health Economics and Outcome Research 2

Figure 1: Sources of health economics and outcome research (HEOR) evidence

Need of HEOR Evidences

The HEOR evidences are helpful in identifying unmet needs and addressing evidence gaps. The real-world data can be used to determine primary randomized control trial (RCT) endpoints (e.g. laboratory test results) which is considered as the most relevant clinical outcomes for physicians and healthcare decision makers. These evidences also help in promoting the patient-centered research and helps in developing and evaluating the cost containment strategies.

Tools for HEOR

There are several approaches which can be applied to the collected evidences through which a meaningful outcome can be achieved. Below are some tools which are used to analyze data.

  • Exploratory Data Assessment
  • Epidemiology study
  • Cost-benefit Analysis (CBA)
  • Cost of Illness Analysis
  • Budget Impact Model (BIM)
  • Cost-effectiveness Analysis (CEA)
  • Satisfaction Assessment
  • HRQL Analysis
  • Assessment of Analysis Compliance and Persistence
  • Market Assessment
  • Pricing Strategy

Types of Outcomes

Generally, the outcomes are of three types namely, clinical outcomes, economic outcomes and humanistic outcomes.

Health Economics and Outcome Research-2Today there is increased emphasis on HEOR activities due to the growing power of payers in the healthcare decision-making. This has led to HEOR professionals covering all aspects of drug development to ensure they have the right data and analysis. This growing importance of HEOR is reflected in the phenomenal increase in the field-based HEOR professionals employed by the pharma companies.

Turacoz Healthcare Solution (THS) aim to deliver the best quality and guideline compliant documents to the pharma and different sectors of healthcare industry. We are dedicated in providing scientific/medical writing support to the industry and academia. With expertise in several clinical trial related documents like Investigator Brochures (IBs), Protocols, Clinical Study Reports (CSRs) Prescribing Information (PI), and Common Technical Documents (CTDs). We also provide services for health economics and outcome research.

Maintaining Work-Life Balance for Healthy and Fulfilling Life

People have argued about the concept of “Work-Life Balance” for decades and it implies something distinctive to everybody. Some might think that the balance is achieved when they can leave work early enough to eat dinner with family. While others might view it as having a flexible schedule, so that they can incorporate their other interests along with work like studying part-time. Yet some others might feel fulfilled spending their “free” time progressing their career.

‘Work-life balance’ is the term used to describe the balance that an individual need between time allocated for work and other aspects of life. The saying goes that ‘All work and no play makes Jack a dull boy’.

Achieving Optimal Work-Life Balance

It can be challenging to attain a great work-life balance, particularly when organizations downsize, and individuals are anticipated to take on additional assignments, or when your obligations at domestic front conflict with those at work.

The methodologies underneath can assist you achieve a balance. A few of them may suit you way better than others, so choose the ones you think will work best for you.

Here are a few ways to improve your work-life balance:

1. Work-Life Balance does not mean an equal balance, there is no ‘perfect’ balance.

When we hear “work-life balance,” we probably envision waking up early, going for work-out, getting meal, heading off to work, have lunch, come home early, cook dinner, and retiring to bed by 9 PM with a nice book and going off to sleep by 10 PM. however, that’s often not the case.

Trying to schedule equal number of hours for work and personal activities is usually unrewarding and unrealistic. Life is and ought to be more fluid than that. We should not strive for the perfect schedule but, for a realistic one. Some days, you might focus more on work, while other days you might have more time and energy to pursue your hobbies or relax with your loved ones. Balance is achieved over time and not every day.

2. Be productive at work

The more productive and efficient you are at work, the simpler it is for you to go home at a sensible time.

Make sure you like your job. If you hate what you are doing, you aren’t going to be happy and content. You don’t have to love every aspect of your work, but it needs to be exciting enough that you don’t fear getting out of bed every single morning.

3. Prioritize your health.

Prioritizing your health, will make you a better employee and individual in true sense. Your overall wellbeing should be your fundamental concern. In the event you’ve been struggling with anxiety or depression and you think any treatment would benefit you, fit those sessions into your schedule, even if you need to leave work early or take time off from other activities.

4. Flexibility

Flexibility plays a vital role in maintaining a good work-life balance. Research has shown that people who believe they have flexible jobs look more favorably on their work-life balance than those with the same workload but with no perceived flexibility. It also found that team members who think their jobs are flexible do longer hours before their workload has a negative effect on them.

Another research came to similar conclusions: you are more likely to stay and feel satisfied in your job if you have access to flexible working arrangements.

Ask your boss to permit more flexibility in your schedule. Perhaps, you could work from home occasionally, come in and leave early, or have some flexibility with your working hours. Job sharing, when two people split the responsibilities of one role, is another well-known option.

5. Finding time for yourself

Work-life balance means having time for yourself as well. While your work is important, it shouldn’t be your whole life. You should prioritize work, activities or hobbies that make you happy.

The people and the work that you love deserve your best, and you can only give it when you stay healthy and look after yourself.

To bring more balance in your life, review how you spend your time, identify and eliminate low-value tasks and try to put more efforts on activities that you believe will make difference. Be flexible and add flexibility to your schedule. Discover the reason and fulfillment in whatever work you do.

Turacoz Healthcare Solutions understands the significance and importance of maintaining a perfect work-life balance and supports its each employee to ensure that they stay stress-free and enjoy their work without their personal lives being hampered. We also urge every working individual to take charge in achieving the same. Let us all pledge to bring in the perfect blend of personal and professional life.

Desktop Yoga: Don’t just sit there! Start Yoga

 

With the years passing, International Yoga Day, has received super positive response from people from all walks of life.
Yoga, introduced to the world by India, was developed in ancient India. Current Indian Prime Minister Mr. Narendra Modi actively performs Yoga and encourages people to take it up. Each year on International Yoga Day, he performs Yoga himself amongst thousands of Indian citizens.

With our lives getting increasingly busy, we hardly find time to devote to our health which leads to increasing health issues. Yoga helps us to relax and rejuvenate and improve our health in the long run.

Current lifestyle of corporate personnels forces everyone to be at their desk for 8-12 hours a day. This sedentary lifestyle among office-goers takes a huge toll on the respective physical health.

How our bodies get affected?
Constantly glaring at the computer screens while sitting might seem normal but alas! For our bodies it is different. Being a couch potato doesn’t help at all. By constantly being seated in the office chair or couch:

  • Our risk of getting a heart disease increases by 64%.
  • We can become prone to specific types of cancer.
  • We are technically wasting 7 precious years of your life.

So, in simple words, sitting is bumping us off.

What must be done?
Not going to office is not the solution. Then what? If we go to office, we need to sit. But worry not, Turacoz Healthcare Solutions lists out a logical and practical way to help you cope with the issue.

While we cannot convert your office seat to a gym, we can do something light yet effective for our body to keep it healthy. Let us all benefit from “DESKTOP YOGA”.

What is DESKTOP YOGA?
Desktop Yoga is simply a string of easy-to-perform exercises based on traditional yoga and are crafted particularly for the community of working people.

These exercises not only helps our body to relax but also re-energizes us helping us to focus better. It’s also appropriate for people who don’t want to put in much effort and exercise. We can perform desktop yoga easily while sitting on your office chair and ensure towards minimizing your stress.

Desktop yoga spots the muscles that are usually affected while we sit for prolonged hours. It is body part specific, so it is up to us in terms of duration in which we want to practice it.

We, at Turacoz HealthCare Solutions practice Desktop Yoga and aim to spread awareness regarding it thus promoting its practice. For us, the well-being of our employees is of primary concern and we sincerely believe that only a fit and healthy employee can perform at his true and best potential.

The following images depicts the different steps and types of “DESKTOP YOGA”

Desktop yoga

Along with performing these basic exercises, we must also follow few basic but golden tips to stay fit and healthy, both physically and mentally:

  • Must eat healthy food, avoid junk
  • Avoid sitting in one position for too long. We must stand up and take a walk and stretch our body at regular intervals
  • Avoid looking at the screen for elongated hours, must blink frequently to keep our eyes moist.
  • Avoid stress as much as possible and take interest in various hobbies
  • Practice meditation and
  • Stay positive and happy

Turacoz Healthcare Solutions wishes everyone a very happy International Yoga Day and urges all to opt for a healthy and happy lifestyle. STAY FIT, STAY HIT.

Transparency in Scholarly Publishing

A research publication is considered as the highest-level medium of dissemination of research findings. Scholarly publications play an important role in disseminating findings, thoughts, and analysis to the scientific, academic, and lay communities. Transparency is an ethic that strengthens the credibility and integrity of research work as well as bonding among the scholarly communities. Due to frequent questioning on research credibility, pressure for open access by governments, and high incidences of research frauds, it has become important to form and follow the principles of transparency.

Principles of Transparency

The Committee on Publication Ethics (COPE), the Directory of Open Access Journals (DOAJ), the Open Access Scholarly Publishers Association (OASPA), and the World Association of Medical Editors (WAME) together have structured the principles of transparency, discuss all aspects of publication ethics and formulate the best practices to overcome any issue in this regard. The various principles of transparency and best practice in scholarly publishing are described as under:

These principle also help in differentiating the legitimate journals and publishers from the non-legitimate ones.

As per transparency, the scholars should give an access to the research data and methods employed for deriving the conclusion. The data production methods should be shared in a much wider platform. If scholar’s research is based on another researcher’s data, he or she should always cite their data clearly. The rules of data confidentiality, wherever applicable should be followed ethically.

Both the perspectives of transparency, viz. transparency in policy context and transparency in research process should be followed to make the scholarly publishing stronger and more reliable.

Publication plan carrying complete information about all types of publications or articles to be formed from the research or clinical studies also contributes towards ethical practice. A proper and firm publication planning can help researchers follow appropriate publishing practices, in time publication of research and hence, increased transparency.

Turacoz Healthcare Solutions (THS) provides end-to-end medical publication writing support including scholarly or academic publication, research publication, manuscripts, slide deck as well as regulatory writing support for clinical trials which includes Prescribing Information (PI), Investigator Brochures (IBs), Protocols, Clinical Study Reports (CSRs), Clinical Evaluation Reposts (CERs) and Common Technical Documents (CTDs). Our documents are guideline compliant and are as per the current pharma and the healthcare standards. We aim to extend our services to different domains of the industry around the globe.

‘World No Tobacco Day’ (31st May 2018): Tobacco and Heart Disease.

World No Tobacco Day (WNTD) is celebrated every year on 31st May, since its beginning in 1988. The main aim to mark this day is to encourage a 24-hour period of abstinence from all forms of tobacco consumption around the world. It also aims to spread awareness about the widespread prevalence of tobacco use and the health risks associated with tobacco consumption. The resolution to celebrate 31 May as WNTD was passed by the World Health Assembly (WHA) in 1998 (WHA40.38). The World Health Organization (WHO) has continuously supported WNTD, every year for this campaign and decides on a theme for the day to create a more unified global message. The global theme for WNTD 2018 is – “Tobacco and Heart disease”. The theme focuses on the association between tobacco consumption and cardiovascular health and aims to inculcate the sense of refraining from tobacco use among general people.

Tobacco contains nicotine, a drug classified as potent parasympathomimetic stimulant. Nicotine is a poisonous alkaloid of the plant genus Nicotiana (family Solanaceae). The WHO declared tobacco as the world’s single greatest preventable cause of death in 2008.

Tobacco use is an important risk factor for the development of various diseases such as cancers (lung, blood, kidney, bladder, brain etc.), respiratory diseases, cardiovascular diseases (CVDs), coronary heart disease (CHD), stroke, peripheral vascular disease, pregnancy complications etc.

Key Facts from 2017 World Tobacco Reports

  • Worldwide, each year tobacco causes nearly 6 million deaths, and current trends show that tobacco use lead to more than 8 million deaths annually by 2030.
  • Almost every child regularly breathe air polluted by tobacco smoke in public places.
  • As per the WHO’s, Global Health Observatory (GHO) data 2016, 40% of children are exposed to second-hand tobacco smoke, accounting for over 600,000 deaths per year. Close to a third of those deaths were reported in children under the age of five and two-thirds were in Sub-Saharan Africa (SSA) and South Asia.
  • In 2011, tobacco caused one-tenth of CVDs worldwide. About 12% of all heart disease deaths are due to the use of tobacco and second-hand smoke.
  • After high blood pressure, tobacco use is the second leading cause of CVD.

Aim of the World No Tobacco Day 2018

  • Highlighting the connection between the use of tobacco products and CVDs.
  • Increasing awareness within the masses to refrain from tobacco use and resist exposure to second-hand smoke to improve their cardiovascular health.
  • Promoting heart health by feasible government actions and public measures that can help to reduce the risks to heart health posed by tobacco.
  • Encouraging countries to include tobacco control in their national agenda.

Turacoz healthcare solutions, aims to increase awareness about the negative health impact of tobacco consumption and motivate them to refrain from the use of tobacco products. We must all join hands and raise our voice against both active and passive smoking so that a brighter and healthier future can be ensured for our younger generation and our Nation. Turacoz is a medical communications company, which offers services to healthcare professionals in clinical research, regulatory writing, publication writing, medico-marketing writing, and support for conducting medical advisory board meetings.

IMRAD in Original Research Articles

IMRAD is nothing but the acronym used for the 4 basic sections of an original research article, namely Introduction, Methods, Results, and Discussion. Any original article must include these 4 essential parts. Diagrammatic representation of IMRAD is depicted in Figure 1. Each of these sections are designed to answer certain questions as described below.

Introduction – Why was the study carried out? What is the specific question to be answered? What is already known, and what is being sought? What is the specific objective?

Introduction must be written in present tense. It must start with broad topics and gradually narrow down to the precise study topic. Thus, this section must provide the background information, set the stage for the article, and build-up the reader’s interest. It must highlight how the study intends to fill-in the existing gaps and what it will add to the current knowledge that already exists.

                                                                                          Figure 1. Diagrammatic Representation of IMRAD

Methods – When, where, and how was the study conducted?

Methods must be written in past tense. This section must clearly describe how the study was designed and carried out, what was the sample, and how it was collected. Procedures conducted must be described comprehensively in a chronological order. The methods section must describe the outcomes being evaluated in the order of their relevance to the research question. Statistical analysis methods used must also be described here. Methods must be presented such that the process could be reproducible.

Results – What was found?

Results must be written in past tense. This is the most important part of any research article as it provides answers to the questions asked in introduction section. Results must be presented in a simple structured way so that they are easy to read and understand. Tables and figures must be included to present the results. If required, results can be organized in subsections. All outcomes must be reported in this section in the same order in which they have been mentioned in the methods section of the article. Results must be only reported in this section and not interpreted or discussed. Specific statistical data such as p-values must be included.

Discussion

What do the results mean? How do the results compare with the existing published literature? What are the implications and future directions?

Discussion must be written in both present and past tense. Established knowledge must be written in past tense and discussion of current results must be written in present tense. This is the most difficult section to write as the author must put everything together in a comprehensive way and should attempt to draw conclusions from the results obtained. Results must be discussed here with an emphasis on the most significant observations. These observations must then be compared with previously published similar studies. Strengths and limitations of the study must be mentioned. Some speculative discussion can be included, which can serve as the source for future research.

Discussion section can be followed by conclusion section where the overall findings can be summarized succinctly.

We, at Turacoz Healthcare Solutions (THS), provide customized medical communication support. Our wing, Turacoz Skill Development Program (TSDP), provides training solutions in various forms to help the healthcare and pharma professionals improve their skills. Although medical writing is a skill and one gets better at it only by practice, equipping oneself with certain basic tools would be a very good start. Here, we share the basic concept of IMRAD in original research articles, which will help budding writers to understand the importance of following this structure while developing manuscripts.

 

World Down Syndrome Day – Let Them Be Heard!

World Down Syndrome Day (WDSD) is a global awareness day which has been officially observed by the United Nations since 2012. Every year it is observed on 21 March with the same zeal and enthusiasm. On this day, people with Down syndrome and their close friends and acquaintances throughout the world organize and participate in events to raise public awareness.

Why the Date March 21?

The date for this day was selected being the 21st day of the 3rd month to signify the uniqueness of the triplication (trisomy) of the 21st chromosome which is the cause of Down syndrome.

Who Manages WDSD Platform?

The WDSD website is managed by the charity organization, Down Syndrome International (DSi). DSi created this platform as a single global meeting place where everyone can share their experiences, advertise their activities and participate in DSi’s WDSD initiatives. The website is a hub of activity taking place around 21 March each year. DSi, a global network of individuals and organizations from all over the world, is committed to improve the quality of life of people affected by Down syndrome and advocating their inherent right to be accepted.

What is the WDSD-Theme this year?

Each year DSi takes up a theme to champion the cause of Down syndrome. The theme for WDSD this year, My Voice, My Community, has been taken up to encourage people with Down syndrome, and their supporters to speak their mind, and let their voice influence government policy and action, to ensure that they can be included, on a full and equal basis with others, in all aspects of society.

What is Down Syndrome?

Down syndrome is a naturally occurring chromosomal arrangement that has always been a part of the human condition, being universally present across racial, gender or socioeconomic lines, and affecting approximately 1 in a few hundred live births, although there is considerable variation worldwide. Per an estimate given by the United Nations, the incidence of Down syndrome is between 1 in 1,000 to 1 in 1,100 live births worldwide. Down syndrome usually causes varying degrees of intellectual and physical disability and associated medical issues.

 

DSi encourages people all over the world to help raise awareness of what Down syndrome is, and how people affected with this disorder play a vital role in our lives and communities. Turacoz Healthcare Solutions, as a part of its corporate social responsibility, joins hands with DSi to raise awareness about Down syndrome and for the well-being of the affected people. Our aim is to communicate our concern and draw more people to be a part of this campaign for those who need our help.

Dehydration and Importance of Oral Rehydration Salts

Introduction

Dehydration is a condition where free water loss exceeds free water intake. Around 2/3rd of the human body is composed of water, and helps in various functions such as lubrication of the joints and eyes,digestion, flushing out of wastes and toxins, and maintaining the balance of minerals (salts and sugar) in our body. Dehydration may occur due to exercise or diseases, high environmental temperature, not drinking enough fluids, persistent vomiting and diarrhea, sweating due to fever etc.

Causes for Dehydration

There are different conditions which may cause dehydration. Some of them are as follows:

  • Gastrointestinal: Diarrhea and vomiting due to gastroenteritis, cholera, yellow fever or infection of the gastrointestinal tract leads to dehydration as well as an electrolyte imbalance.
  • Sweating:Excessive sweating due to vigorous exercise, sports, fever, heavy manual work, climatic conditions etc. results in fluid loss and dehydration.
  • Alcohol intake: Alcohol is a diuretic and stimulates urination resulting in dehydration.
  • Diabetes: In diabetes, kidney removes extra glucose along with water, which in turn may result into dehydration.
  • Blood loss: Excessive loss of blood can also result in dehydration.

People can tolerate 3-4%decrease in total body water without any difficulty. But 5-8% decrease can cause fatigue and dizziness and above 8% can prove to be dangerous.

Signs and Symptoms

The early signs of dehydration include feeling thirsty and lightheaded, dry mouth,tiredness,having dark colored face, strong smell in urine, passing urine less often than usual etc.

Remedies and Treatments

  • Drink plenty of fluids such as water, squash or fruit juice and avoid caffeinated beverages and fizzy drinks.
  • In illnesses such as vomiting or diarrhea, it is difficult to maintain optimum water level in our body. In such cases, it is better to have small sips of water or other fluids.
  • Infants and children who are dehydrated or having diarrhea should be given oral rehydrated salts (ORS)as recommended by World Health Organization (WHO) instead of water.This is because water can dilute the already low levels of electrolytes and minerals in the body. ORS is a mixture of electrolytes and sugars mainly given to restore imbalance of body fluids. It is very helpful in adults suffering from dehydration, vomiting, and diarrhea.

Importance of ORS

  • ORS is a special combination of dry salts (electrolytes) that are mixed with water. It can help to replace the fluids lost due to diarrhea and vomiting.
  • ORS is important because it helps to rehydrate the body with essential electrolytes, especially sodium and potassium.
  • In severe case of dehydration, when fainting or unconsciousness occurs, ORS can be given through intravenous injections for replenishment of necessary electrolytes and water.
  • In mild dehydration, an oral rehydration can be given which is less painful, and less expensive as compared to ORS given through intravenous route.
  • ORS can be prepared at home by simply mixing 6 level teaspoons of sugar and 1/2 level teaspoon of salt in 1 liter of clean water.
  • ORS is the best treatment option for dehydration

Turacoz Healthcare Solutions is engaged in spreading awareness among people regarding any healthcare issues. We consider it our responsibility to create awareness about any health-related issues in the general public.