Tag Archives: #MedicalWritingTips

Eight Ways to Improve Clarity in Medical Writing

Introduction to Medical Writing

Medical writing involves producing clear, precise documents of high quality to effectively communicate scientific, medical, and clinical data to a wide range of target audiences. It also includes regulatory writing and medical communications.  With the constant advancements in clinical research, large amounts of data must be translated to target audiences such as regulatory authorities, healthcare professionals, patients, and the general public in a clear, explicit, and well-structured format. Apart from thorough technical knowledge, a medical writer must have excellent writing skills to convey complex scientific information credibly and clearly.

Types of Medical Writing

Clarity in Medical Writing

Clarity is the most valued quality required in medical writing to ensure that the audience perceives correct information without any ambiguity. Lack of clarity is the major issue affecting timely submission of research/regulatory documents, publication acceptance rate, and, accessibility of scientific information to health care providers and patients.

Eight Ways to Improve Clarity in Medical Writing:

  1. Clear and Concise Language:
    • Writing in clear language makes a document easy to understand and increases readability.   It is advisable to use simple words to convey accurate information; using sophisticated words often results in confusion and misinterpretation of data. The best practice is to write simple, short sentences containing one idea per sentence for easy interpretation and keeping it concise by using fewer words to communicate necessary information without eliminating any important data.
  2. Avoid Jargons:
    • Using jargon may hinder effective communication especially when the target audience are non-experts in the field of interest. Though experts like scientists or health care providers are aware of medical jargons, it is always recommended to use simpler words and phrases for better communication.
    • When writing for non-experts such as the general public, it is best to avoid jargons completely. For example, writing ‘fast heart rate’ instead of tachycardia, ‘muscle pain’ instead of myalgia, makes it easier to understand.
  3. Avoid Redundancy:
    • Contrary to the assumption that using more words enhances clarity, it may in fact distract the reader from the original idea. It merely adds length to the document without providing any additional information. Do not repeat information that is already presented in the form of tables and figures. This can be achieved by limiting the overuse of synonyms, double negatives, and intensifiers.
  4. Know your Audience:
    • A medical writer offers services to a diverse range of audiences including clinical and regulatory authorities, physicians, patients, and general public. For effective communication, the scientific content has to be tailored according to the target audience. Even cutting-edge research would not leave an impact on the industry experts if it is not documented to suit their level of comprehension. Similarly, when writing for non-experts, the use of plain language is advised to enhance accessibility. Graphical presentation or images can be considered as a good option to convey complex information in a simpler way.
  5. Active over Passive Voice:
    • Medical writers are encouraged to write in active voice for clarity. It helps to present data in a simple, straightforward, and concise manner.
  6. Grammar and Spellings:
    • Good grammar is instrumental to clear and effective medical writing. Grammatically accurate paper conveys precise meaning and in turn keeps the audience engaged. Proper use of punctuations, hyphens, commas aids facilitate comprehensive communication. Similarly, avoiding spelling mistakes helps decipher the right information; a single error in spelling may change the entire meaning of the sentence. A common challenge experienced is with homophones (words with same pronunciation but different meaning); one needs to be vigilant to avoid misinterpretations.
    • It is also important to consider whether to write in British English or US English depending on the target audience and maintain consistency throughout the document.
  7. Formatting:
    • A well written report without proper formatting appears misconstructed. Often standard documents are required to comply with specific regulatory formats. Implementing client specific formatting guidelines aids in improving clarity thereby increasing the level of acceptance.
  8. Proofreading:
    • Once the document is written, proofreading the entire work is extremely critical to check for any inconsistencies or errors in spelling, grammar, abbreviations, capitalizations, and formatting. This step significantly aids in the dissemination of clear, accurate scientific information.

Conclusion

Medical writers play a crucial role in knowledge transfer among scientists, industry experts, healthcare providers, and the public. Accurate interpretation of sophisticated data is essential for good understanding. Articulating well-structured, precise documents can be achieved by implementing various techniques for improving clarity in medical writing.

Medical Writer: Trusted Partner for Medical Affairs Webinar

To get more detailed insights about Medical Writing, we encourage you to register for our upcoming live webinar on 8th January 2022: Webinar Registration Fee (razorpay.com).

World Malaria Day : Understanding Malaria

Malaria is a serious life-threatening parasitic disease caused by parasites known as Plasmodium vivax (P.vivax), Plasmodium falciparum (P.falciparum), Plasmodium malariae (P.malariae) and Plasmodium ovale (P.ovale). Its transmission takes place through the infective bite of Anopheles mosquito. Man develops this disease after 10–14 days of being bitten by an infective mosquito.

Every year April 25 is celebrated as “World Malaria Day” across the globe in an effort to provide effective control of the disease. This occasion also provides a common platform for the affected countries to share experiences, showcase technologies and collaborate in programs in the fight against malaria.

SIGNS AND SYMPTOMS OF MALARIA

Symptoms of malaria include fever and flu-like illness, including shaking chills, headache, muscle aches, and tiredness. Nausea, vomiting, and diarrhea may also occur. Malaria may cause anemia and jaundice (yellow coloring of the skin and eyes) because of the loss of red blood cells. Infection with one type of malaria, P. falciparum, if not promptly treated, may cause kidney failure, seizures, mental confusion, coma, and death.

POPULATION AT RISK

In 2015, approximately 3.2 billion people—nearly half of the world’s population—were at risk of malaria.

Maximum number of malaria cases and deaths occur in sub-Saharan Africa. However, Asia, Latin America, and, to a lesser degree, the Middle East, are also at risk. In 2015, 97 countries and territories had ongoing malaria transmission.

DISEASE BURDEN

  • According to the latest WHO estimates, released in December 2015, there were 214 million cases of malaria in 2015 and 438,000 deaths.
  • Between 2000 and 2015, malaria incidence among populations at risk reduced by 37% globally; during the same period, malaria mortality rates among populations at risk registered a decline by 60%. An estimated 6.2 million malaria deaths have been averted globally since 2001.
  • Sub-Saharan Africa continues to contributethe highest share of the global malaria burden. In 2015, the region accounted for 88% of malaria cases and 90% of malaria deaths.

PREVENTIVE MEASURES FOR CONTROLLING MALARIA

  • Taking antimalarial drugs to kill the parasites
  • Eliminating places where mosquitoes breed
  • Spraying insecticides to kill adult mosquitoes that come inside
  • Sleeping under bed nets—especially effective if they have been treated with insecticide, e.g. insecticide-treated mosquito nets (ITNs) and
  • Wearing insect repellent and long-sleeved clothing if out of doors at night.

CURRENT SCENARIO OF MALARIA VACCINE

  • Effective malaria vaccine could helpeliminate and eradicate malaria; there are currently 63 vaccine candidates, 41in preclinical and clinical stages of development.
  • Vaccines are being designedto target pre-erythrocytic stages, erythrocytic stage or the sexual stages ofPlasmodium taken up by a feeding mosquito, or the multiple stages
  • Twovaccines in preclinical and clinical development target falciparum; and themost advanced candidate is the pre-erythrocytic vaccine RTS,S which is inphase-III clinical trials.
  • RTS,S/ASO1 is the first malaria vaccine to have completed pivotal Phase 3 testing and obtained a positive scientific opinion by a stringent medicines regulatory authority.
  • Collaborators of RTS,S Clinical Trials Partnership showed that RTS,S/AS01 prevented a substantial number of cases of clinical malaria over a 3–4-year period in young infants and children when administered with or without a booster dose. Efficacy was enhanced by the administration of a booster dose in both age categories. Thus, the vaccine has the potential to make a substantial contribution to malaria control when used in combination with other effective control measures, especially in areas of high transmission.

Turacoz Healthcare Solutions is committed to spread the awareness on such social or healthcare related issues as a part of their Corporate Social Responsibility (CSR) activity. Our medical writing team is well versed with recent advances in various therapeutic areas which gives them a head start in various publication, clinical research and regulatory writing projects.

World Glaucoma Week

World Glaucoma Week (March 6-12, 2016) : Be Informed, Be Safe

Each year the World Glaucoma Association (WGA) and the World Glaucoma Patient Association (WGPA) come together to raise awareness about Glaucoma across the world. This joint initiative of WGA and WGPA is marked as “World Glaucoma Week” which is observed from March 6-12 each year worldwide.

What is Glaucoma?

‘Glaucoma’ is a group of progressive optic neuropathies that damage the optic nerve thereby resulting in degeneration of retinal ganglion cells, vision impairment, and blindness. Though unusually high intraocular pressure is been identified as the most common cause for glaucoma, yet this may not always be the case. The two most prevalent types of glaucoma are primary open-angle glaucoma (diagnosed in 90% of cases) and closed angle glaucoma. The common symptom of open angle glaucoma is a gradual loss of peripheral vison (generally in both eyes) which progresses to having a tunnel vision. Whereas, eye pain, blurred vision, nausea and vomiting, vision issues in low light, halos around light sources and red eyes are the common symptoms of closed angle glaucoma.

What is the Global Burden of Glaucoma?

Worrisome is the fact that most of the time onset of glaucoma (particularly in open angle glaucoma) are asymptomatic and disease go unnoticed by patients and healthcare professionals until it progresses to advance stages. Due to the silent nature of the disease, glaucoma is often labelled as ‘silent thief of sight’. It is worth mentioning that, glaucoma is the second leading cause of blindness globally, after cataract. The silent nature of the disease and rapid progression adds up to the global prevalence of glaucoma. In the year 2010, about 60 million people were found to be affected by glaucoma globally, and it is expected that the toll will rise up to 79 million people worldwide by 2020.

Who is at risk of having Glaucoma?

Even though glaucoma can affect any individual, but the risk increases if the individual is; over 60 years of age, have a family history of glaucoma, African Americans or Mexican American, uses steroids, have diabetes, high blood pressure and hypothyroidism, and other eye conditions.

What are the treatment Options?

Treatment of glaucoma varies according to the type of glaucoma, patient history, and advancement of the condition. Usually, the healthcare professional may prescribe medical interventions like; prostaglandins, beta blockers, carbonic anhydrase inhibitors, cholinergic or miotic agents, and alpha-adrenergic agents to relive intraocular pressure. Surgery is considered as therapeutic options if the drugs are not well-tolerated by the patient or if drugs fail to stop the progression of the disease. In such cases, healthcare professionals opt for surgeries like; trabeculoplasy, viscocanalostomy, and aqueous shunt implant.

What are the Preventive Measures?

Even though glaucoma cannot be prevented, but early screening and management of symptoms do reduces the advancement of disease and chances of having a complication. Proper awareness about the disease increases the chances of glaucoma getting a screening in its earlier stage thereby helping healthcare professionals in the timely management of the condition and preserving eyesight of the patient. Regular eye check-ups are recommended in the high risk group. It is also recommended that an individual should immediately consult a health care professional if anything unusual is observed in vision.

What should be done to Spread Awareness about Glaucoma?

‘Awareness is the first step for prevention’, and spreading awareness about glaucoma is anticipated to considerably lower the global burden of disease and associated blindness. World Glaucoma Week is one such initiative to aware masses about glaucoma.  The World Glaucoma Association (WGA) and the World Glaucoma Patient Association (WGPA) runs a week long awareness campaign to make people aware about the disease. It is recommended that healthcare professionals should involve their glaucoma patients as they organize a screening event in their local institute/hospital, should give a lecture to a patient support group, should participate in radio & TV shows to talk about glaucoma and to answer questions, and should contact newspapers to publish information about glaucoma. Additionally, all the health care professional are also suggested to run public health campaigns, eye checks up camps, and patient education classes for the high risk group. As a member of healthcare industry, we all should actively take up the responsibility to spread awareness about glaucoma in our own way. Remember to be informed is to be safe!

World Kidney Day – Kidney Disease & Children Act Early to Prevent It!

World Kidney Day (WKD) is a joint initiative of the International Society of Nephrology (ISN) and the International Federation of Kidney Foundations (IFKF). The first campaign was initiated ten years ago. Since then, the day is observed every year to raise public awareness of kidney diseases which affect millions of people worldwide, including children who may be at risk of kidney disease at an early age.

Fast Facts:

  • 10% of the global population is affected by kidney disease, and it claims the lives of millions of people each year.
  • Acute kidney injury (AKI) develops in children when red blood cells are destroyed and block the kidneys’ filtering system, or due to trauma such as burns, dehydration, bleeding, injury or surgery.
  • Chronic kidney disease (CKD) in children can be caused by birth defects.
  • A person can lose up to 90% of kidney function before experiencing any signs of CKD.
  • From birth to age 4, birth defects and hereditary diseases are the leading causes of kidney failure.
  • The majority of children with kidney disease progress to end-stage kidney diseases in adulthood.

Mission Statement

The mission of World Kidney Day is to educate people about the importance of our kidneys to our health and to reduce the frequency of kidney disease and its associated health problems worldwide.

Kidney Disease & Children. Act Early to Prevent It

This year’s World Kidney Day campaign emphasizes the importance of following kidney function and blood pressure in children and babies. Kidney disease can affect children in various ways, ranging from treatable disorders without long-term consequences to life-threatening conditions. It is our responsibility to encourage education, early detection and a healthy lifestyle in children, starting at birth and continuing through to old age, to combat the increase of preventable kidney damage including acute kidney injury (AKI) and chronic kidney disease (CKD) and to treat children with inborn and acquired disorders of the kidney.

Objectives of World Kidney Day

  • Raise awareness about our “amazing kidneys”
  • Highlight that diabetes and high blood pressure are key risk factors for CKD
  • Encourage preventive behaviors and systematic screening of all patients with diabetes and hypertension for CKD
  • Educate all the doctors and health care professionals about their key role in detecting and reducing the risk of CKD, particularly in high risk populations
  • Emphasize the important role of local and national health authorities in controlling the CKD epidemic.

What can you do for your kidneys?

Kidney diseases are silent killers and largely affect the quality of life. There are a few easy ways to reduce the risk of developing kidney disease.

  • Keep fit and active: Physical activities and exercises help you to keep fit. This will reduce your blood pressure and therefore reduces the risk of Chronic Kidney Disease.
  • Check your blood sugar level: People who have diabetes are more likely to develop kidney damage, so it is important for all to have regular tests for blood sugar level to check their kidney functions. Kidney damage from diabetes can be reduced or prevented if detected early. Keeping control of blood sugar levels with the help of doctors or pharmacists is very important.
  • Monitor your blood pressure: High blood pressure is also the most common cause of kidney damage. High blood pressure is especially likely to cause kidney damage when associated with other factors like diabetes, high cholesterol and Cardio- Vascular Diseases. The normal blood pressure level is 120/80. Between this level and 139/89, you are considered pre-hypertensive. At 140/90 and above, you need to consult your doctor and monitor your blood pressure level regularly.
  • Eat healthy and keep your weight under control: This can help many conditions associated with Chronic Kidney Disease such as diabetes and heart diseases. Reduce your salt intake. The recommended sodium intake is 5-6 grams of salt per day (around a teaspoon). Limit the amount of processed and restaurant food and do not add salt to food. Prepare the food yourself with fresh ingredients.
  • Maintain a healthy fluid intake: To maintain good health, one should consume 1.5 to 2 litres of water per day. Consuming plenty of fluid helps the kidneys clear sodium, urea and toxins from the body which, in turn, results in a “significantly lower risk” of developing chronic kidney disease. Moderately increased water intake may reduce the risk of decline in kidney function. The right level of fluid intake for any individual depends on many factors including gender, exercise, climate, health conditions, pregnancy and breast feeding. People who have had a kidney stone are advised to drink 2 to 3 litres of water daily to lessen the risk of forming a new stone.
  • Quit smoking: Smoking slows the flow of blood to the kidneys, which impairs their function Smoking increases the risk of kidney cancer by about 50 percent.
  • Do not take over-the-counter pills on a regular basis: Common drugs such non-steroidal anti-inflammatory drugs like ibuprofen are known to cause kidney dysfunction if taken regularly. Such medications probably do not pose significant danger if your kidneys are relatively healthy and you use them for emergencies only, but if you are dealing with chronic pain, such as arthritis or back pain, ask your doctor to control your pain without putting your kidney at risk.

 

Publication Writing: What Gets Accepted and What Gets Rejected?

What is a Publication?

Publications are a healthcare solution which bridges communication of research conducted to the researchers around the world. To publish is to make content available to general public making use of text, images, or other audio-visual content. Publications include books, journals, magazines, newspapers, catalogues etc. A scientific publication is a written and published report describing original research results. Scientific communications aim to communicate new scientific findings in a clear and concise manner.

Barriers in Publishing!

  • Adherence to ethical and scientific standards
  • Format and Documentation Issues
  • Lack of expertise in research methods, incentive, and support for publishing findings
  • Quality problem: interventions are too well studied and do not represent “new knowledge”
  • Intervention does not have good face validity
  • Intervention was tested in a non-generalizable population/setting; sample too small
  • Study design is not robust; study is underpowered to detect significant effects
  • Outcome measures are too few, irrelevant, or inaccurate
  • Manuscript writing is unclear; intervention is not well described

Common Reasons Leading to Manuscript Rejection

A questionnaire based study reported the following to be the most commonly observed flaws leading to manuscript rejection:

 

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Publication Solutions at Turacoz

Turacoz Healthcare solutions based at New Delhi is a budding medical communications organization specializes in various communications including clinical research and regulatory writing; medical marketing solutions; and publication writing. Turacoz focusses on the client’s requirement and delivers projects as per the client’s specifications. At Turacoz, we believe in delivering projects which brings the client back to us.

Training And Development

“Anyone who stops learning is old, whether at twenty or eighty. Anyone who keeps learning stays young. The greatest thing in life is to keep your mind young.” – Henry Ford

The most important aspect of our lives and our work is “continuous learning”. Nobody in the world can stop a person who has willingness to learn more and more. Be it school, college, office, or our personal life, everything is based on learning new things every day. However, learning becomes an easy task if there is someone to guide you and to train you.

And there comes the importance of TRAINING AND DEVELOPMENT!

Training is defined as a learning process in which a person acquires knowledge and appropriate skills to excel in a particular role. This process helps in the development of an individual and thus, plays an important role in improving the status of an organization, society, as well as a country. However, it is a short-term process and is specific to a particular job/role/skill. On the other hand, development is a long-term process that helps to improve the overall dimensions of an individual, and makes him better equipped to handle any sort of situations.

The important thing is not only training, but the timing and type of training. Imagine a twelve class student being trained on the basic concepts of physics which he had already learnt in class nine, or a training imparted on waste management to the student of economics. Such kind of trainings would just be a waste of time, resources, as well as money. Thus, the most significant aspect of training is the correct type of training to the right people at the most appropriate time.

Usually when we talk about training and development, what comes to our mind is the “human resource development”, i.e. training and development programs that are conducted in an organization for enhancement of the skills of its employees.

So let’s see why do we need training and development in an organization?

  • To enrich the employees with latest technology and knowledge.
  • To match employee specifications with the job requirements.
  • To improve or enhance the skill-set of employees.
  • For personal development of the employees.
  • To improve the quality of work and minimize the wastage of resources.

There are different types of trainings that are conducted based on the requirements of the employees as well as the organization. So let’s look at the various types of training?

  • Induction training: To make the new employees familiar with the procedures, code of conduct, policies, and work profile of an organization.
  • Job training: To improve the knowledge and skills of an employee for his designated job.
  • Refresher training: To incorporate the latest developments, and upgrade the skills of the employee.
  • Safety training: To minimize the accidents and ensure safe working in an organization.
  • Promotional training: For training of the existing employee before his promotion.
  • Remedial training: To overcome the shortcomings of the employees.
  • Internship training: To provide practical knowledge to the students via combined efforts of the educational institutes and industries.

Usually, any training can be imparted via two methods:

  • On-job training methods: Includes job rotation, coaching, job instructions, assignments, and internships.
  • Off-job training methods: Includes lectures, conferences, seminars, case studies etc.

However, any training should not just be the dump of information. It should suit the requirements of the employees and serve their needs. We can say that training and development is effective only if it imparts new and necessary skills, is practical-oriented, and aligns the training needs with the goals of the organization

Some of the advantages of training and development are:

  • Improved knowledge and skills at the level of organization
  • Improved corporate image
  • Organizational development
  • Increased profits of the organization
  • Increased morale of the employees

Nevertheless, there are certain challenges associated with the training and development process like:

  • Difficulty in identifying the needs of the employees
  • Individuals might be resistant to learn
  • Expensive process
  • Needs time and resources
  • Equips staff to resign for better jobs

In a nutshell, we can say that training and development are very important in an organization for its continuous progress. Although it is a challenging and expensive process, training and development in the right direction can help the individuals/employees as well as organization in their growth, and thus, can prove to be a worthwhile investment.

As it is well said, “Leadership and learning are indispensable to each other.” – John F. Kennedy

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. 

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. 

#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. 

#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.