Category Archives: Medical Writing

5 Medical Writing Tips for Novice Writers

5 Medical Writing Tips for Novice Writers

  • Always start with an outline and ensure that all the relevant questions are answered:
    •  What is the research topic and what is its importance?
    •  What is the hypothesis formulation strategy?
    •  What were the expected results and the major findings of the study?
  • Create an IMRAD strategy:
    •  Introduction: Importance of study, what is already known, hypothesis, objectives
    •  Materials and Methods: Materials, subjects, design, procedure used for study
    •  Results: Findings of the study and related to study
    •  Discussion and Conclusions: Discussion of supporting studies , previous literature, limitations, future prospects of study
  • Prepare the draft:
    •  Start with materials and methods
    •  Be specific, clear, concise, and objective in writing results (prepare figure/ table wherever required)
    •  Start with the introduction to attract the reader by highlighting the novelty of the study, followed by discussion
  • Review the draft as a reviewer:
    •  Review the paper thoroughly and revise it
  • Submit the final draft according to journal guidelines
    •  Follow the order: title page; abstract and key words; main text; acknowledgements (optional); conflicts of interest (optional); references; author information; figure legends; tables
    •  Be strict for word limits (total word count/ abstract’s word count)
    • Take care of number of figures and tables to include
    •  Make sure that the reference style in text as well as bibliography is followed

 

THS shares a few tips on medical writing for novice writers. At THS, we provide medical writing assistance to healthcare professionals. Medical writing is a creative way of communication for those who love to write and want to keep abreast with the recent developments in science. While writing a manuscript, try to follow these tips and prepare the manuscript as per the instructions given by a journal. However, its acceptance and publication is not at your will. You may, sometimes, face rejection at initial stages. Revise, edit and modify your paper. Keep practicing. Brush up your writing skills and get ready to type your next manuscript.

Importance of Macro-Editing in Medical Writing

Editing is an important task that is performed by an editor with a good scientific background and good editing skills. Once a manuscript is finalized, it is reviewed for editorial concerns. It includes checking the content or the information in order to ensure that the thoughts or concepts are expressed clearly and in a logical way to form a comprehensive and meaningful information on the whole. Editing requires critical thinking and careful analysis of the information. It is broadly divided into micro- and macro-editing.

Micro-editing deals with the technical aspects and ensures the language and style are correct and consistent. On the other hand, macro-editing ensures transparency, accuracy, and consistency of the information in the document. Following things are generally rectified during macro-editing :

  1. Logical flow of story from one paragraph to the next
  2. Clarity and completeness of the information
  3. Clearly mentioned rationale/purpose of the document
  4. Information is oriented towards the target reader
  5. Accuracy of data
  6. Tables and figures are cited appropriately in the document
  7. Supportive references are accurate and mentioned appropriately in the text
  8. Conclusions are succinctly summarized
  9. Other things that are taken care during editing include sentence structure, repetitiveness of information, language style (tone and voice), parallelism in the statements, paragraph structure, and word and phrases usage with proper meaning depending on the context

The best way for macro-editing is that the writer self-checks the document based on the below-mentioned questions:

  • Is the introductory paragraph clear enough to indicate the purpose and provide a broad outline of the content?
  • Is every statement relevant to the purpose of the study, with no deviations?
  • Does the text flow reasonably from one paragraph to the next paragraph?
  • Are the sentence structures and language varied enough, without too much repetition?
  • Are the evidences or references given to statements appropriate?
  • Is the terminology consistent throughout the text, or if more than one term has been used to refer to something, is it clear that they are one and the same thing?
  • Is the language and tone appropriate for the reader?
  • Does the information provided in the document meet the readers’ needs?
  • Are the conclusions clearly and effectively summarized?
  • Is the content in the draft aligned as per the journal or congress guidelines?
  • Are the page, text, tables, figures, references, and other information formatted as per the style sheet?

Turacoz Healthcare Solutions (THS) shares the importance of macro-editing in medical writing. Being a medical writing company, Turacoz is involved in publication writing, training solutions, and skill development program. We offer medical writing solutions at par with the latest trends in journal-publication.

Role of a Medical Writer in Advisory Board Meetings

Medical writing is a multidimensional profession which requires creating numerous scientific/non-scientific documents for various phases of a drug life-cycle. Different types of documents prepared by a medical writer are later utilized by the pharmaceutical companies in procuring approval from the regulatory bodies and for knowledge sharing with the healthcare stakeholders. These documents may include (but are not limited to) documents for pre-clinical studies, clinical trials, and post-marketing studies,reports of advisory board meetings, patient educational material, and promotional material. Among all the above-mentioned documents, writing reports for advisory board meetings is an integral part of the medical writing profession.

What is an Advisory Board?

Advisory boards are considered as an important tool for understanding the unmet medical or healthcare needs of a drug/product. By forming an ‘advisory board’, the pharmaceutical companies or medical societies aim to engage their key opinion leaders (KOLs)in order to get better insights on the various medical benefits/limitations of their products from the medical fraternity. Productive discussions held during the advisory board meetings are used to gather visions on possible research opportunities, including guidance on the clinical development and trial protocols, as well as unmet health care needs of current clinical practices that might drive future clinical strategies. The organizing body usually involves a medical writer during an advisory board meeting for capturingevery detail of the discussion held at the medical advisory board meeting and later drafting an objective-driven report which is shared at different knowledge sharing platforms.

What is the Role of a Medical Writer?

The responsibility and role of a medical writer vary according to the objective of the advisory board and according to the type of report required by the organizing body. This may include:engaging KOLs for an advisory board, preparing questionnaires, conducting online surveys (for understanding unmet needs), preparing a pre-meeting report to be shared with KOLs, preparing presentations for the advisory board meeting, hosting an advisory board, capturing minutes of meeting, preparing draft for meeting report, and modifying the report into a publication-ready literature. Hence, it is very important that a medical writer has a prior understanding of the objective of the meeting and nature of deliverable.

Turacoz Healthcare Solutions provides end-to-end support for conducting an advisory board and preparing high-quality scientific reports of the meeting. We have successfully conducted several national and global advisory boards related to preclinical research and product positioning in the past two years and look forward to partnerships in future. Turacoz has experienced medical writers who understand the requirements of our clients and efficiently capture the body and soul of an advisory board meeting.

Uniform Code of Pharmaceuticals Marketing Practices (UCPMP) – Code for Writing Promotional Material

The Department of Pharmaceuticals (DoP), Government of India, released Uniform Code of Pharmaceuticals Marketing Practices (UCPMP) on 1st January 2015.
UCPMP is a voluntary code that should be adopted by pharmaceutical industry to curb unethical practices in the healthcare sector. UCPMP bears significance as pharmaceutical companies have been accused of massive enticements to secure prescriptions from the medical fraternity for a very long time.

UCPMP for promotional materials:

  • All promotional material issued by a product authorization holder or with his authority, must be consistent with the requirements of this Code.
  • Where the purpose of promotional material is to provide persons qualified to prescribe or supply with sufficient information upon which to reach a decision for prescribing or for use, then the following minimum information, must be given clearly and legibly and must be an integral part of the advertisement:
    • The relevant product authorization number and the name and address of the holder of the authorization or the business name and address of the part of the business responsible for placing the medicinal product on the market
    • The name of the product, and a list of the active ingredients, using the common name, placed immediately adjacent to the most prominent display of the name of the product
    • Recommended dosage, method of use and, where not obvious, method of administration
    • Adverse reactions, warnings and precautions for use, and relevant contraindications of the product
    • A statement that additional information is available on request
    • The date on which the above particulars were generated or last updated
  • Promotional material such as mailings and journal advertisements must not be designed to disguise their real nature. Where a pharmaceutical company pays for or otherwise secures or arranges the publication of promotional material in journals, such promotional material must not resemble editorial matter.
  • Promotional material must conform, both in text and illustration, to canons of good taste and must be expressed so as to recognize the professional standing of the recipients and not be likely to cause any offence.
  • The names or photographs of healthcare professionals must not be used in promotional material.
  • Promotional material must not imitate the devices, copy, slogans, or general layout adopted by other companies in a way that is likely to mislead or confuse.
  • Where appropriate (for example, in technical and other informative material), the date of printing or of the last review of promotional material must be stated.
  • Extremes of format, size, or cost of promotional material must be avoided.
  • Postcards, other exposed mailings, envelopes or wrappers must not carry matter which might be regarded as advertising to the lay public or which could be considered unsuitable for public view.
  • Audio-visual material must be accompanied by all appropriate printed material so that all relevant requirements of the Code are complied with.

Other key highlights of UCPMP are:

  • No gifts, pecuniary advantages or benefits in kind may be supplied, offered or promised to persons qualified to prescribe or supply drugs, by a pharmaceutical company or any of its agents i.e. distributors, wholesalers, retailers, etc.
  • Free samples of drugs shall not be supplied to any person who is not qualified to prescribe such products
  • Companies or their associations/representatives or any person acting on their behalf shall not extend any travel facility inside the country or outside, including rail, air, ship, cruise tickets, paid vacations, etc., to healthcare professionals and their family members for vacation or for attending conference, seminars, workshops, etc. as a delegate
  • Companies should not pay any cash or monetary grants to any healthcare professionals for individual purpose in individual capacity under any pretext
  • Funding for medical research, study etc., can only be extended through approved institutions by modalities laid down by law/rules/guidelines adopted by such approved institutions, in a transparent manner

Need for UCPMP – Self-regulation in pharma marketing has hardly worked anywhere

Many international pharmaceutical trade associations, which are primarily the lobbying bodies, strongly advocate self-regulations (such as following UCPMP) by the industry. They have also created many documents in this regard, which are also displayed in their respective websites. However, despite all this, the ground reality is that, the well-hyped self-regulation by the industry to stop the menace of pharma marketing malpractices is not working; few recent examples are cited below:

  • March 2014 – the anti-trust regulator of Italy reportedly fined two Swiss drug majors, Novartis and Roche 182.5 million euros (U$ 251 million) for allegedly blocking distribution of Roche’s Avastin cancer drug in favor of a more expensive drug Lucentis that the two companies market jointly for an eye disorder.
  • March 2014 -A German court fined 28 million euro (US$ 39 million) to the French pharma major Sanofi and convicted two of its former employees on bribery charges.
  • May 2013 – Sanofi was reportedly fined US$ 52.8 Million by the French competition regulator for trying to limit sales of generic versions of the company’s Plavix.
  • August 2012 – Pfizer Inc. was reportedly fined US$ 60.2 million by the US Securities and Exchange Commission to settle a federal investigation on alleged bribing of overseas doctors and other health officials to prescribe medicines.
  • April 2012 – a judge in Arkansas, US, reportedly fined Johnson & Johnson and a subsidiary more than US$1.2 billion after a jury found that the companies had minimized or concealed the dangers associated with an antipsychotic drug.

As per the recent information available, the government is planning to make the UCPMP practices mandatory, which have so far been voluntary. The DoP is working on to finalize the mandatory code practices. The move has been triggered by insufficient compliance to the existing voluntary code by pharmaceutical companies. The mandatory codes will also involve legal implications and invoking of marketing licenses.

Turacoz healthcare solutions fully believe in following ethical codes such UCPMP. Our medical writing team is well versed with these codes and tries to adapt to the same while providing promotional material content to our client.

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. 

Grammar Hammer: Few Tips to Better Yourself in English Grammar

Practice Flawless English for Good Scientific Writing

Knowledge of grammar is one of the keys to writing clearly and credibly. Whether you are learning a grammar rule for the first time or refreshing your memory, some basic points of English language and grammar need to be kept in mind before you start penning down a scientific document. The medical writer must know the target audience for a particular document. The scientific information in these documents must be presented to suit the level of understanding of the audience, namely, patients or general public, and the physicians. The main advantages of plain English are:

  • It is faster to write
  • It is faster to read, and
  • You get your message across more often, more easily and in a friendlier way

A few tips given here will help you to avoid common grammar and usage errors. These errors are the usual careless mistakes that are checked when a document is being edited and proof-read.

Avoid the Common Grammatical Errors

  • Use Formal Language in the Document
  • Do not write as you would in a medical register/log book. Use articles (a, an, the) wherever necessary, to complete your sentences; e.g., the patient came to the clinic; not patient came to clinic.
  • Many of us think in our mother tongue. While writing, however, avoid in incorrect sentence formations and check for such errors.
  • Avoid using slang/colloquial language that you may use in college, e.g., breast cancer, not CA Breast.
  • Make Clear Comparisons

When drawing comparisons, make it clear as to what or who you are comparing with; do not assume that the reader knows.

For example: We found that the virus affected children more [than adults].

  • Avoid Jargons And Clichés
  • Use of jargons in the document should be minimum. Jargons, if used, must be explained.
  • Get to the point and avoid clichés, such as

– “As you may already be aware…”

– “It is a well-known fact that…” etc.

  • Use Simple Language
  • Be punchy and keep sentences short (not more than 15-20 words in one sentence). Readers may lose track of the meaning if the sentence is too long.
  • Use active voice and first person as much as possible. Active voice is more reader-friendly. Passive voice unnecessarily complicates the sentence. For example, “We found that…” not “It was found that…”
  • Give proper commands wherever necessary. The most common fault is putting ‘customers should do this’ or ‘you should do this’ instead of just ‘do this’. To avoid them from sounding harsh, you can put the word ‘please’ in front. However, if something must be done, it is best not to say ‘please’ as it gives the reader the option for refusal of request.

For example,

  1. The document needs to be reviewed with track-changes. (Passive voice)

   Please review the document with track-changes. (Command)

  1. You should just think of it as a complete statement. (Passive voice)

Just think of it as a complete statement. (Command)

  1. Writers should aim to be precise. (Passive voice)

Be precise. (Command)

  1. They should be split where suitable. (Passive voice)

Split them where suitable. (Command)

  • Reduce Nominalization of Verbs

Nominalized verbs are the nouns which are often used in place of the verbs from which they are derived. Like passive verbs, they also make the sentences dull and heavy.

      Verb                    Nominalization

Complete              Completion

Introduce              Introduction

Arrange                Arrangement

For example,

  1. We had a discussion about the matter. (Nominalized verb)

We discussed the matter. (Verb)

  1. There will be a stoppage of trains by drivers.(Nominalized verb)

Drivers will stop the trains.(Verb)

  • Reach Out to The Readers
  • Be gender-inclusive in your writing. Do not use the general pronoun ‘he’ to include women; instead, use ‘they’.
  • If that is not possible in certain cases, use ‘he or she’.
  • Keep your tone conversational, and avoid words that you wouldn’t use naturally. Terms like ‘therefore’, ‘thus’, and ‘hence’ – should be used less frequently, as they prevent them from connecting with the readers.
  • An article with informative subheadings, bulleted lists and pointers is likely to grab more readership than a plain document with mere cluster of statements and paragraphs.

The Need to Improve Writing Skills

A medical writer is responsible for communicating scientific information. In addition to understanding the scientific aspects, he or she needs to present the information in a clear manner and at a level of understanding appropriate to the target audience. Use of grammatically error-free language, simple short sentences, and active voice with a logical flow of ideas can go a long way in making the information understandable to the readers and garnering huge readership.

 

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.