Ethical conflicts in career of medical writers

Medical writers develop content linked with the pharmaceutical, medical, healthcare, and bio-medical sciences. In performing that role, they often face a dilemma about how much they can change or add content so that their writing is not classified as that of a paid ghost writer. This is one of several ethical issues that are an integral part of a medical writer’s career.

With flexibility in terms of working hours, medical writers are able to explore new interdisciplinary fields to develop content. However, crossing the thin line into the realm of ghostwriting is a grave ethical concern in cases where the manuscript is being submitted  to an academic journal for publication.Ethical conflicts

Following are some of the allied issues that have been questioned in a medical writer’s career from an ethical standpoint:

  • Incorrect interpretation of the results by the writer will not only adversely affect the research but also the credibility of the writer.
  • Inadequate research on the specific research topic and related issues might lead to errors of omission or commission, which will finally have a bearing on the quality of the final output.
  • Pharmaceutical companies are constantly evolving existing drugs and introducing new ones. This might position the medical writer on the cusp of uncertainty because such developments necessitate last minute  changes in the manuscript and, possibly, even the conclusions. Conversely, ignoring such new data will jeopardize the research output.
  • Akin to any other field of writing, plagiarism is a bane for medical writers. Often, medical writers are tempted to present someone else’s research work, either wholly or partly. This unethical practice is resorted to as a shortcut to keep abreast of tight deadlines imposed by the author for writing and submitting a research paper.
  • Authorship issues also pose problems for medical writers. They need to follow the journal guidelines and keep at arm’s length the issues related to conflict of interest vis-à-vis the sole proprietor of the manuscript or the research.

Medical writers need to take cognizance of all these potential pitfalls while developing content because such awareness helps them excel in the field of medical writing and leads to a clear understanding of their work objectives.

Gift authorship: A provocative issue

Assigning authorship for the real contributors can be a tricky business for the scientific or the academic writers.

What is gift authorship? In simple terms, it is defined as the co-authorship, conferred to those having a little or no intellectual contribution in the study. Gift authorship provides just an authority stamp for the non-contributors.

Authorship criteria: The person affiliated under this type of authorship, do not meet the authorship criteria defined by various international bodies. According to one of the giant international body, known as International Committee of Medical Journal Editors (ICMJE), authorship criteria are stated as follows:

(i) Substantial contributions to conception and design, acquisition or collection, analysis and interpretation of data;

(ii) Drafting or revising the article, critically for important intellectual content; and

(iii) Giving the final approval of the edited version of the article, to be published.

Ethical viewpoint of gift authorship: Gift authorship is regarded as highly unethical and irrelevant, as the author honored with the title of authorship holds no contributing hands, neither in the designing nor in data analysis; he/she do not meet the authorship criteria. He/she may not have expertise in the field to which the study is related, which may bring dismay to the institute or the publishing journal. This kind of authorship has cropped up in an intense way in the medical writing field, demanding an immediate action to be taken against this illegal authorship, as this dilutes the credentials of the authors who have done the real work, related to the study protocol.

Reasons for researchers opting for gift authorship: There are many identified reasons that put the precocious researchers to opt for the option of gift authorship.  Some of the most cited reasons are:

(i) Superiority complex of the guide or the lead supervisor. They do not allow any research article publication by their junior counterparts; and

(ii) Certain researchers believe that assigning the names of their head supervisor or institutional head can lead to increased readability and help in publication of their articles.

The researchers should think of undermining such authorship that leads to the loss in the credibility of the real contributing authors and diluting their work profile.

Analytical Study Designs in Medical Research

In medical research, it is important for a researcher to know about different analytical studies. The objectives of different analytical studies are different, and each study aims to determine different aspects of a disease(s) such as prevalence, incidence, cause, prognosis, or effect of treatment. Therefore, it is essential to identify the appropriate analytical study associated with certain objectives. Analytical studies are classified as experimental and observational studies. While in an experimental study, the investigator examines the effect of presence or absence of  certain intervention(s), he does not need to intervene in a observational study, rather he observes and assesses the  relation between exposure and disease variable. Interventional studies or clinical trials fall under the category of experimental study where investigator assigns the exposure status. Observational studies are of four types: cohort studies, case-control studies, cross-sectional studies, and longitudinal studies

Classification of Analytical studies

While experimental studies are sometimes non indicative or not ethical to conduct or very expensive, observational studies probably are the next best approach to answer certain investigative questions. Well-designed observational studies may also produce similar results as controlled trials; therefore, probably, the observational studies may not be considered as second best options. In order to design an appropriate observational study, one should able to distinguish between four different observational studies and their appropriate application depending on the investigative questions. Following is a brief discussion on four different observational studies (each will be discussed in detail individually in my upcoming blogs):

 

Observational Analytical Study Designs

Cohort studies

Cohort methodology is one of the main tools of analytical epidemiological research. The word “cohort” is derived from the Latin word “cohors” meaning unit. The word was adopted in epidemiology to refer a set of people monitored for a period of time. In modern epidemiology, the word is now defined as “group of people with defined characteristics who are followed up to determine incidence of, or mortality from, some specific disease, all causes of death, or some other outcome” (Morabia, 2004). In cohort studies, individuals are identified who initially do not have the outcome of interest and followed for a period of time. The group can be classified in sub sets on the basis of the exposure. For example, a group of people can be identified consisting of both smoker and non-smoker and followed them for the incidence of lung cancer. At the beginning of the study none of the individuals have lung-cancer and the individuals are grouped into two sub sets as smoker and non-smoker and then followed for a period of time for different characteristics of exposure such as smoking, BMI, eating habits, exercise habits, family history of lung cancer or cardiovascular diseases, etc. Over the time, some individuals develop the outcome of interest. From the data collected over time, it is convenient to evaluate the hypothesis whether smoking is related with the incidence of lung cancer. The following schematic shows the basic design of a cohort study. There are two types of cohort studies: prospective and retrospective. A prospective study is conducted at present but followed up to future i.e., waiting for the disease to develop. On the other hand, a retrospective study is carried out at present on the data collected in the past. This is also called as historic cohort study. In the next blog, I will discuss these in detail.

Design of a Cohort study

Case-control studies

In terms of objective, case-control studies and cohort studies are same. Both are observational analytical studies, which aim to investigate the association between exposure and outcome. The difference lies in the sampling strategy. While cohort studies identify the subjects based on the exposure status, case-control studies identify the subjects based on the outcome status. Once the outcome status is identified the subjects are divided into two sets: case and control (who do not develop the outcome). For example, a study design which determines the relation between endrometrial cancer with use of conjugated estrogen. For this study, subjects are chosen based on the outcome status (endrometrium cancer) i.e., with disease present (case) and absent (control), and then these two subsets are compared with respect to the exposure (use of conjugated estrogen). Therefore, case-control study is retrospective in nature and cannot be used for calculating relative risk. However, odd ratio can be measured, which in turn, is approximate to relative risk. In cases of rare outcomes, case control study is probably the only feasible analytical study approach.

Design of a Case-Control Study

Cross-sectional studies

Cross-sectional study is a type of observational analytical study which is used primarily to determine the prevalence without manipulating the study environment. For example, a study can be designed to determine the cholesterol level in walker and non-walker without exerting any exercise regime or activity on non-walkers or modifying the activity of the walkers. Apart from cholesterol other characteristics of interest, such as age, gender, food habits, educational level, occupation, income, etc., can also be measured. The data collected at one time in present with no further follow up. In cross-sectional design, one can study a single population (only walkers) or more than one population (both walker and non-walker) at one point of time to see the association between cholesterol level and walking. However, the design of this study does not allow to examine the causal of a certain condition since the subjects are never been followed either in past or present. 

Design of a Cross-Sectional Study

Longitudinal studies

Longitudinal studies, similar to cross-sectional studies, are also a type of observational analytical studies. However, the difference of this study design with the cross-sectional study is the following up the subjects for a longer time; hence, can contribute more to the association of causative to a condition. For example, the design that aims to determine the cholesterol level of a single population, say the walkers over a period of time along with some other characteristics of interest such as age, gender, food habits, educational level, occupation, income, etc. One may choose to examine the pattern of cholesterol level in men aged 35 years walking daily for 10 years. The cholesterol level is measured at the onset of the activity (here, walking) and followed up throughout the defined time period, which enables to detect any change or development in the characteristics of the population.

Following two tables summarize different observational analytical studies with regard to the objectives and time-frame.

Fig5

I will define several terms, such as risk factor, odd ratio, probability, confounding factors, etc., related to study designs along with the detail discussion on individual analytical study design and tips to choose correct design depending on the research question in my upcoming blogs. Visit the blog section of the website (www.manuscriptedit.com) for more such informative and educative topics. 

References

[1] Morabia, A (2004). A History of Epidemiologic Methods and Concepts. Birkhaeuser Verlag; Basel: p. 1-405.

[2] Hulley, S.B., Cummings, S.R., Browner, W.S., et al (2001). Designing Clinical Research: An Epidemiologic Approach. 2nd Ed. Lippincott Williams & Wilkins; Philadelphia: p. 1-336.

[3] Merril, R.M., Timmreck, T.C (2006).  Introduction to Epidemiology. 4th Ed. Jones and Bartlett Publishers; Mississauga, Ontario: p. 1-342.

[4] Lilienfeld, A.M., and Lilienfeld, D.E. (1980): Foundations of Epidemiology. Oxford University Press, London.

Concept of Medical Writing

Medical writing is quite different compared to other kinds of professional writings. The concept of medical writing involves writing different types of scientific documents relating to research, disease- or drug-related promotional content, journal articles for publication, and content for websites, magazines or news focused on health care.

Doing adequate research is the most vital aspect of medical content writing. You also need to have knowledge of terminology from various fields. Apart from that, the points discussed below will help you to get a basic idea of how to go about it.

Tips for Medical Writing

  • The purpose of medical writing is to convey the medical information to the readers in an easily understandable way. Therefore, the information that you present should be target-specific, i.e., it should be presented to suit the level of understanding of the target readers who may be general public, patients, or medical professionals.
  • Medical writing has a serious aspect to it as people will take crucial decisions based on what they read. So, you need to present your facts correctly. You have to do considerable research before you write. While doing so, ensure that you gather information only from trusted sources.
  • If you are writing content for a website, the tone of your writing should be conversational. The sentences should be short and to the point.
  • Remember that your readers will not be only medical professionals. People might face difficulties in understanding medical terms. Explain the complex medical terms and procedures in as simple a way as possible.
  • The visual setting of the article is also very important. So, your content should be properly structured. Include subheadings and bulleted/numbered lists wherever possible.
  • There should be no grammatical mistakes in your content. For ex: A misplaced punctuation might seem to be a trivial thing, but it is enough to change the meaning of a sentence altogether.

Due to the rise in the number of medical and research organisations, the significance of medical writing has also gone up. There is considerable demand for well written and well-organized content that can be easily understood by all.

COHESION

Cohesion words or phrases define the association between one sentence and the next. These words or phrases link a sentence with its pervious or next sentence, thus, helping readers to relate the sentences and the authors intended meaning. The writer can use but, however, in spite of, or some other similar linking word or phrase; however, one should take care of correct grammatical structure.

Let us take the examples of some cohesion words and the relationship they express.

  • Enumerative cohesion words/phrases introduces the order in which points will be made. Examples: first, second; one, two; a, b; next, then, subsequently, finally, in the end
  • Additive words reinforce or confirm what was said. Examples: again, then again, also, moreover, furthermore, in addition, what is more

These words also highlight similarity. Examples: equally, likewise, similarly, correspondingly, in the same way

  • Explanatory words introduce examples. Examples: for example, for instance
  • Illustrative words note alternatives. Examples: alternatively, or again, or rather, but then, on the other hand

Other cohesion words include synonyms, referential pronouns, parallel structure, etc.

Synonyms:

These are words with closely related meanings and help in addressing excessive repetition. If you used approach in one sentence and want to repeat the same idea, then you can use its synonym method in the next sentence. Similarly, for skill, you can use ability, and so no.

However, one should make sure not to overuse them as its excessive usage can make your document confusing and unclear.

Referential pronouns:

If two sentences begin with the same subject, then you can use a personal or referential pronoun in the second sentence instead of the word itself (I, he, she, it, we, they, this, that, these). However, if the use of a pronoun makes the sentence confusing, then you should repeat the noun.

Parallel structures:

Parallelism refers to similar grammatical structures of headings and sentences used within a paragraph, and it adds clarity to your paragraph.

Not parallel: These books are not primarily for reading, but they are used for reference.

Parallel: These books are not primarily for reading but for reference.

Not parallel: Not only is he conscientious worker, but also he is very competent.

Parallel: Not only is he conscientious but also competent.

Parallelism is also important in instructions.

A. Setting up the printer, maintenance, and what to do if something goes wrong are easy with ABC’s step-by-step user guide.

B. Setting up the printer, maintaining it and troubleshooting are easy with ABC’s step-by-step user guide.

Use Exciting Adjectives to Spice up Your Writing

Don’t just say that something is good or bad; empower your nouns with exciting adjectives that describe what you really think. Adjectives like oppressive, tyrannical, and bloodthirsty are powerful because they portray a strong point of view about something or someone.