Monthly Archives: November 2015

Training&Development

‘Medical writing’ is a perfect amalgamation of science and art. As a medical writer, one has to maintain a good balance between the technicality of science and art of communicating with the readers via words. Other than the basic requisite of knowledge of therapeutic areas, and command over the language; medical writing requires an understanding of the medical concepts and terminology, knowledge of relevant guidelines as regards the structure and contents of specific documents, and good writing skills.

The good news is that adeptness of effective medical writing can be easily learned by regular training and development!

Though there is no formal degree / diploma or certification course in medical writing, but there are few resources which can be utilized for gaining expertise in this discipline. These resources include; in-house medical training courses for employees provided by the various organization, short courses / workshops by professional bodies, on-the-job ‘mentor-guided’ training, and motivated “self-study”. Among all these resources, the motivated self –study is the mainstay and pertinent way of learning medical writing. Curiosity to learn and self-motivation can transform any mediocre into a seasoned medical writer. If one has a desire to take medical writing as a full-time career option then these five hacks can surely add value to the work;

#1 Read carefully, read regularly

New knowledge and information are constantly being added to the field of medicine. Every year a large number of papers are published related to various research studies, clinical experience, and new ideas and thoughts related to the healthcare industry. The best way to learn is to read through as many papers as possible. This teaches how to present data and what mistakes to avoid.

All the documents prepared under medical writing strictly abide by one or more technical guidelines issued by the regulating bodies. Therefore, a medical writer should be well-acquainted with the latest technical guidelines followed in different parts of the world. For instance, EU, USA, and Japan have evolved a set of common guidelines (International Conference on Harmonisation [ICH] guidelines) related to drug development and registration. For publication, Good Publication Practices, guidelines for reporting clinical trials (e.g. CONSORT), the International Committee of Medical Journal Editors’ (ICMJE) guidelines for manuscripts are mostly used. A medical writer should keep him/her updated with the latest versions of these guidelines.

Therefore reading carefully and reading regularly is a most important part of medical writing.

#2 Understand your audience well

The documents prepared by the medical writer have a different set of target audience, which may include; healthcare professionals, regulatory bodies, patients, and consumers. A medical writer should always try and take a reader’s perspective to understand how to approach a subject. The information in any document should be targeted in terms of the subject and the audience.
Therefore, it is very important that a medical writer identifies the target audience before writing.

#3 Pre-writing is a must

Pre-writing or drafting is an important part of medical writing. Before writing the first draft, develop a road map. Gain knowledge of the therapeutic area that is to be addressed, this enhance the relevance of articles being searched. Reading about the therapeutic area is very important prior starting the literature search. The literature search should be followed by, arranging key facts and citations from the literature into a crude roadmap/outline. Follow the outline meticulously, for writing a well-organized document.

#4 Write Lucid, clear and crisp

While writing, be clear and specific, and strictly avoid beating around the bush. The main idea/ objective of the document should be clear from first few paragraph of the document. Remember, while reading, a reader follows an “F” pattern i.e. the first few paragraphs are read carefully and the remaining document is scanned in an F pattern. Hence, it is very important to keep all the key information in the first few paragraphs, to keep a reader hooked to the article.Adding sub-heading also helps to catch readers attention.

The information should be well- organized. In the margins of your paper, tag each paragraph with a phrase or sentence that sums up the main point. Then move paragraphs around to improve logical flow and bring similar ideas together.

#5 Revise well before submitting

Before submitting your work, proofread and edit it well. Remember, a sentence written incorrectly will not convey any meaning or add value to your document. Read each sentence more than once to identify grammatical errors. While revising your work; read out loud, do a verb check, cut clutter, do an organizational review, and get feedback from others.

As quoted by William Zinsser- “If writing seems hard, it’s because it is hard. It’s one of the hardest things people do”. Though, practising regularly and keeping one well-versed with the latest happenings of the domain can ease down the task.

Turacoz Healthcare Solutions as a socially responsible company spreads the word and awareness and looks forward to collaboration or associations with other agencies/companies with similar goals and aspirations. We have a skilled and competent team of medical writers, clinicians, researchers and biostatisticians. Our clients include major pharmaceutical companies, hospitals and healthcare professionals. Our experience has been in supporting publications, creating regulatory documents, conducting observational studies, designing and creating for print and digital marketing as well as customizing sessions on medical writing. 

# VaccineHesitancy

As described by the WHO, immunization is the process whereby a person is made immune or resistant to an infectious disease, typically by the administration of a vaccine. Vaccines stimulate the body’s own immune system to protect the person against subsequent infection or disease. In simpler terms, vaccination is your best shot for health. Therefore, for a healthier life it is recommended that everyone should be vaccinated according to schedule advised by their family doctors.

Despite knowing the importance of immunization and easy accessibility of vaccines, people often refuse or deny to vaccinate themselves or their children. “Vaccine hesitancy” is, therefore, the biggest challenge faced by the healthcare system in achieving optimal immunization among masses. It is evident that vaccine hesitancy negatively impacts on vaccine uptake rates and the performance of national immunization programs of the country. The UN health agency reported that globally, one in five children still do not receive routine life-saving immunizations, and an estimated 1.5 million children die each year of diseases that could be prevented by vaccines.

 As per the WHO, denying or refusing vaccination against any disease not only increases the vulnerability of an individual for that particular disease, but it also widens the immunization gap in the population. Vaccine hesitancy is a complex issue that is influenced by multiple factors such as misinformation, complacency, convenience, confidence, and fear of needles. Myths associated with vaccines such as vaccination of women leading to infertility is also a major reason for denying vaccinations, particularly among the rural population.

To overcome these issues, WHO, in the recently published editorial recommended the healthcare organizations to focus on increasing the understanding of vaccine hesitancy, its determinants, and challenges among the lay population. The recommendations also focused on usage of evidence-based practices that are required in dealing with the structures and organizational capacity to decrease hesitancy and increase acceptance of vaccines at the global, national and local levels. Sharing of lessons learned and effective practices from various countries and settings as well as the development, validation and implementation of new tools to address hesitancy were also recommended.

This World immunization day, it is suggestive that pro-active measures should be taken by various health care organizations for increasing acceptance of vaccines, such as:

  • Using effective communication to dispel fears among people
  • One‑on‑one or group interaction between health‑workers and people to resolve their doubts, and myths related to vaccination
  • Organizing number of immunization session for generating awareness about health benefits of vaccination
  • Bringing together interactive activities that engage groups of members and society members to give the guidelines related to immunization
  • Spreading awareness among people about new vaccine availability, its benefits
  • Encouraging people to bring their children for detailed check-up and give vaccine
  • Involving staff members and nurses of health care institutions, primary centers, family‑clinics to maintain the immunization record of the patients and provide them when needed

Immunization is one of the most important preventive health measures, responsible for saving millions of lives. Hence, addressing the concerns of vaccine-hesitancy must be a priority for all the stakeholders of the healthcare industry. So, this world immunization day, each one of us should take it as our moral responsibility to spread awareness among people about the vaccine and to debunk fear/myths associated with vaccination.

Turacoz Healthcare Solutions as a socially responsible company spreads the word and awareness and looks forward to collaboration or associations with other agencies/companies with similar goals and aspirations. We have a skilled and competent team of medical writers, clinicians, researchers and biostatisticians. Our clients include major pharmaceutical companies, hospitals and healthcare professionals. Our experience has been in supporting publications, creating regulatory documents, conducting observational studies, designing and creating for print and digital marketing as well as customizing sessions on medical writing. 

Diabetes Tech Advancemnents

Over the years there are many technological advancements that came into light in the treatment of diabetes. These technological advancements in diabetes care helped from the discovery, production of insulin till the development of less painful ways to deliver it to the patients.

Technological developments will continue and probably even increase, as the epidemic of diabetes continues to grow rapidly. Advances in medical technology can help control diabetes with ease, a more convenient, and a more accurate tool for everyone.

Echo Therapeutics

These are non-invasive, wireless, transdermal continuous glucose monitoring (tCGM) systems for diabetic patients. These provide reliable data continuously, conveniently and in a cost-effective way. Also reduce the dependence on periodic finger stick testing.

Omnipod

These are wireless systems that help in delivering insulin. OmniPod is discreet and durable. Wireless and waterproof, the Pod holds and delivers insulin without tubes or shots. This also programs the personalized insulin delivery, calculates suggested doses, and has a convenient style.

Mobile Devices and Social Media Tools

These help in connecting with others and the healthcare physician. Social media also helps in the maintenance and monitoring of diabetes and helps the diabetic patients connect each other. These websites of diabetes can not only clarify the doubts but also support the patients’ problems. Also mobile devices help in tracking the data and send test results directly to the doctor.

Artificial Pancreas

This is helpful and provides relief for type 1 diabetics. An automated system used to disperse insulin based on changes in blood sugar levels. This is a wearable device acting as an artificial pancreas, the system will enable people living with type 1 diabetes to better maintain blood sugar levels within a target range with minimal effort.

High-Tech Tattoo Sensor

This is again a substitute for the finger-sticking method. This includes a sensor that changes color with rising blood sugar levels. This high-tech tattoo contains a special kind of ink that reacts with glucose and is injected into the outermost layer of skin.

Technology continues to develop and help patients with diabetes with much convenient and easier methods.

Turacoz Healthcare Solutions as a socially responsible company spreads the word and awareness and looks forward to collaboration or associations with other agencies/companies with similar goals and aspirations. We have a skilled and competent team of medical writers, clinicians, researchers and biostatisticians. Our clients include major pharmaceutical companies, hospitals and healthcare professionals. Our experience has been in supporting publications, creating regulatory documents, conducting observational studies, designing and creating for print and digital marketing as well as customizing sessions on medical writing. 

#Biostatistics

Clinical studies are conducted to test the drugs and medical devices in humans before their approval and availability for the commercial market. To understand the results of clinical studies, clinical research professionals need to use statistical analysis. Biostatistics helps them to understand the different aspects of the study which enable to interpret the results of the study in more scientific way. It involves the biostatistician immediately after conceptualization of the research question. This will make sure that you design the study accurately. Introduction of the biostatistician in the middle of the study can result in several pitfalls in the study design.

Now, question may arise why there is need for biostatistics in human research? The simple answer can be to understand the concept of variation and sampling. Attributes are not only different among the individuals but they could also be different within the same individual over the time. Human research mostly conducted on small sample size and it’s indeed a tedious task to express the results from small sample size. Therefore, biostatistics plays an important role in human medical research.

The most common medical writing tips for the use of biostatistics in human research are provided below:

  • How was data collected?

For a survey type of study, describe the method of data collection and provide pertinent details, such as the number of questions, range of questionnaire response scores and the meaning of each score.

  • Use simple models for defined parameters

In data analysis, particularly for complex high-dimensional data, it is frequently better to choose simple models for clearly defined parameters.

  • Which statistical software used?

Mention the statistical software and the version used in the analysis, and details such as the manufacturer of the software, city, and country of origin in parenthesis.

  • What all to describe?

Provide clear descriptions of the main features of the statistical analysis (e.g. confidence interval, including degree of confidence; hypothesis tests, including null and alternative hypotheses; level of significance; particular tests and test statistics).

  • Why is data review essential?

To determine the quality of the data, initially look at the bad data first and then remove the suspected data. This would save a lot of time and rework later.

  • How did you manage outliers?

Describe the procedures that were put in place to handle missing values and data, as well as any outliers (provide the definition used for an outlier).

  • What should be the sample size?

To minimize the sampling error effect, large sample size need to be collected. The confidence interval can then be computed and visualized in excel. This enables to make most of small and large sample sizes.

  • Why should you describe study design?

The study design should be described accurately and in detail so that the study can be reproduced, if required. Study/sampling/data flow charts can be used to describe complicated sampling/study designs.

  • What is the role of data management?

Data management is the foundation to well done studies. Statistical team’s participation during study design is important for well reported results.

  • Some more tips
    • A pleasant appearance, coupled with visual interest, can draw the reader through the text and reduce the effort of reading. Use of tables, figures, and graphs provide visual interest and can help clarify a complex message.
    • Use appropriate measures of central tendency and spread as summary statistics; for instance, report medians for highly skewed data. If using the notation a ± b, clearly state what b is – it could be standard deviation or standard error.
    • Use tables to report summary statistics, summaries of results, or the quantities associated with a p-value.

Biostatistics gives you the rationale behind extrapolating the results to larger population and these figures are very important in our day to day science. Learning the basics of biostatics’ is necessary for medical writers as this knowledge can help them to give the explanations of the results and what impact will they have on patient care and outcome.

Turacoz Healthcare Solutions as a socially responsible company spreads the word and awareness and looks forward to collaboration or associations with other agencies/companies with similar goals and aspirations. We have a skilled and competent team of medical writers, clinicians, researchers and biostatisticians. Our clients include major pharmaceutical companies, hospitals and healthcare professionals. Our experience has been in supporting publications, creating regulatory documents, conducting observational studies, designing and creating for print and digital marketing as well as customizing sessions on medical writing. 

#DiabetesAwarenessMonth

Reduce your risk today: Eat healthy, Walk more and Weigh less

Lifestyle modification for prevention of diabetes mellitus

Structured programs that emphasize lifestyle changes for preventing diabetes are recommended by the American Diabetes Association (ADA) for people at high risk for developing type 2 diabetes. These include:

  • Dietary strategies including low intake of dietary fat and reduced calories
  • Regular physical activity (150 min/week)
  • Moderate weight loss (7% body weight)

Individuals at high risk for type 2 diabetes should be encouraged to achieve the U.S. Department of Agriculture (USDA) recommendation for dietary fibre (14 g fibre/1,000 kcal) and foods containing whole grains (one-half of grain intake). Low–glycaemic index foods that are rich in fibre and other important nutrients are to be encouraged.

Medical nutrition therapy

Medical nutrition therapy (MNT) is a therapeutic approach for treatment of medical conditions and their associated symptoms via the use of a specifically tailored diet devised and monitored by a medical doctor, registered dietitian or professional nutritionist.

MNT goals for prevention of diabetes

  • Goals of nutrition therapy for individuals at risk for diabetes or with pre-diabetes

Decrease the risk of diabetes and cardiovascular disease (CVD) by promoting healthy food choices and physical activity leading to moderate weight loss that is maintained.

  • Goals of nutrition therapy that apply to individuals with diabetes
  1.  Maintenance of
  • Blood glucose levels in the normal range or as close to normal as is safely possible
  • Lipid profile that reduces the risk for vascular disease
  • Blood pressure levels in the normal range or as close to normal as is safely possible
  1. Prevention of, or decrease in, the rate of development of the chronic complications of diabetes by modifying nutrient intake and lifestyle.
  2. Consideration of individual nutrition needs and personal preferences with willingness to change.
  3. Maintenance of the pleasure of eating by only limiting food choices as indicated by scientific evidence.
  • Goals of MNT applicable to specific situations
  1. For youth with type 1 diabetes, or type 2 diabetes, pregnant and lactating women, and older adults with diabetes, meeting the nutritional needs for such specific times is important.
  2. For patients being treated with insulin or insulin-stimulating medication, self-management training is essential for safe conduct of exercise, including the prevention and treatment of hypoglycaemia, and diabetes treatment during acute illness.

Significance of weight loss in pre-diabetes and diabetic conditions

  • Weight loss is recommended for all such individuals who have or are at risk for diabetes. In obese insulin-resistant individuals, modest weight loss has been shown to improve insulin resistance.
  • Physical activity, exercise and behaviour modification are important and most helpful in reducing body-weight.
  • For weight management, either low-carbohydrate or low-fat calorie-restricted diets may be effective in the short term (up to 1 year).
  • For patients on low-carbohydrate diets, monitoring of lipid profiles, renal function, and protein intake (in those with nephropathy), and adjustment of hypoglycaemic therapy is recommended.
  • Weight loss medications may be considered in the treatment of overweight type 2 diabetes patients and can help achieve 5–10% weight loss when combined with lifestyle modification.
  • Bariatric surgery may be considered for some individuals with type 2 diabetes and BMI ≥35 kg/m2 and can result in marked improvements in glycaemia.

Turacoz Healthcare Solutions as a socially responsible company spreads the word and awareness and looks forward to collaboration or associations with other agencies/companies with similar goals and aspirations. We have a skilled and competent team of medical writers, clinicians, researchers and biostatisticians. Our clients include major pharmaceutical companies, hospitals and healthcare professionals. Our experience has been in supporting publications, creating regulatory documents, conducting observational studies, designing and creating for print and digital marketing as well as customizing sessions on medical writing. 

#PublicationEthics

Publishing the results of a study completes the research conducted. As mentioned by EH Miller, “If it was not published, it was not done”. Although there are numerous guidelines and checklists that one follows under the publication cycle, following publication ethics is of top priority. Every aspect of publishing a manuscript is guided by ethical principles. Most peer reviewed journals, keep publication ethics their top most requirement failing which the manuscript cannot be accepted. The World Association of Medical Editors (WAME) strives to reinforce and make recommendations on publication ethics to the scientific community.

Any study begins with a study design. The study design must be made to adequately address the research question. Approval of the study design with every aspect must be obtained prior to the beginning of the study from the institutional review board or ethics committee. In addition, all animal studies must be conducted with full compliance of the local, national, ethical, and regulatory principles, and the local licensing arrangements.

Ensuring that the work being published is original, all authors enlisted are aware of the submission, obtaining copyright permission for tables and figures, including paper affiliations, and ensuring that the manuscript has not been submitted to more than one journal at a time are a mandate for following publication ethics. Other important types of ethical violations include failure to inform the editor regarding related papers, unrevealing the conflict of interests which may affect the results of the study, misinterpretation of research findings by the use of selective or fraudulent data to support a hypothesis or claim.

Breach of publication ethics sooner or later come to light leading to unavoidable consequences. In most cases, the manuscript is retracted or the authors may be asked to submit an apology to the corresponding journal of submission. In severe cases, the authors of the paper may be blacklisted from further submissions in the journal which can hamper the reputation of the authors in the scientific committee.

In conclusion, any kind of breach can be avoided by preparing a focused manuscript with originality. Appropriate citing of references to avoid plagiarism and declaration of conflict of interests among the authors must be considered. Adequate knowledge of the ethical guidelines is the key factor for preparation of documents which comply with all ethical principles.

Turacoz Healthcare Solutions as a socially responsible company spreads the word and awareness and looks forward to collaboration or associations with other agencies/companies with similar goals and aspirations. We have a skilled and competent team of medical writers, clinicians, researchers and biostatisticians. Our clients include major pharmaceutical companies, hospitals and healthcare professionals. Our experience has been in supporting publications, creating regulatory documents, conducting observational studies, designing and creating for print and digital marketing as well as customizing sessions on medical writing.