Perspectives in Clinical Research

PUBLICATION PERSPECTIVE
Year
: 2021  |  Volume : 12  |  Issue : 4  |  Page : 229--233

Advice to authors for avoiding flaws in preparation of original research manuscripts


Arun Bhatt 
 Consultant Clinical Research and Drug Development, Mumbai, Maharashtra, India

Correspondence Address:
Dr. Arun Bhatt
303-4, Dheeraj Valley 3/C, Mohan Gokhale Road, Goregaon (East), Mumbai - 400 063, Maharashtra
India

Abstract

Preparation of manuscripts of original research for publication is the final and critical step in the conduct of clinical research. Most manuscripts are rejected because of flaws in design, methodology, interpretation, and writing. Understanding the reasons for rejection can help clinical researchers in avoiding common errors in all sections of manuscript – introduction, methods, results, and discussion. The article highlights the reasons for rejection of original research manuscripts and suggests approaches to improve the quality of the manuscript.



How to cite this article:
Bhatt A. Advice to authors for avoiding flaws in preparation of original research manuscripts.Perspect Clin Res 2021;12:229-233


How to cite this URL:
Bhatt A. Advice to authors for avoiding flaws in preparation of original research manuscripts. Perspect Clin Res [serial online] 2021 [cited 2022 May 27 ];12:229-233
Available from: https://www.picronline.org/text.asp?2021/12/4/229/326227


Full Text

In India, academic medical institutions have increasingly focused on publication of original clinical research after the Medical Council of India (National Medical Council) made publication in specified indexed journals mandatory for career advancement and promotions.[1] Young postgraduates, junior faculty members, and several institutions commit a lot of resources and efforts to plan and organize research and prepare manuscripts for publication.

However, they are dejected when the manuscript is rejected. For high citation impact factor journals, the rejection rates could be as high as 90%. Common reasons for rejection include flaws in design, methodology, interpretation, and writing and missing ethical aspects.[2],[3] Understanding the reasons for rejection can help clinical researchers in avoiding common errors in conducting and publishing research.

Before writing manuscript

Lack of novelty/originality in the research question itself and errors in study design are reported as some of the most common reasons for rejection.[2],[3] These errors are considered fatal study flaws, as they cannot be corrected once the study is concluded.[3] The authors – students and their guides – should critically assess whether the research question is Feasible, Interesting, Novel, Ethical, and Relevant (FINER) before beginning the study.[4]

Novelty means that the research could (a) contribute new information, (b) confirm, refute, or extend previous research findings, and (c) improve understanding of concepts of health and disease or medical practice or research methodology.[4] A novel research question need not be entirely original. A thorough review of literature focusing on limitations of previous research could suggest interesting ideas: (1) whether previous results could be replicated, (2) whether the findings in one population would be relaxant to a different population, or (3) whether a new measurement method would help in better interpretation of findings.

Significant flaws in scientific aspects would be: [2],[3],[5]

Poor conceptualization of problemInadequate control of variablesBiased sampleConfounding factors not consideredLack of control groupInadequate sample size.

Important ethics-related errors would be: [2],[3]

Inadequate protection of human subjects – lack of ethics committee approval/written informed consentNo registration in clinical trial registryPlagiarism.

Selection of the wrong journal for that manuscript is not an uncommon issue. The manuscript is likely to be rejected if (1) it is out of scope for the journal[3] or (2) the findings are not of interest to journal readers but to specialist audience or (3) the manuscript is not prepared as per the format or instructions to authors.

During preparation of manuscripts

The format of original research article – IMRAD divided into Introduction, Methods, Results, and Discussion – reflects the process of scientific research.[5] The articles are often not accepted because of errors/flaws in the content, most of which are observed in methods, results, and discussion sections.[2],[3]

 Methods



For the methods section, clarity about how and why a study was done in a particular way is paramount.[5]

Description of methods covers (1) selection and description of participants, (2) technical information, and (3) statistics. This section should provide sufficient details [Table 1] so that other researchers with access to the study data would be able to reproduce the results.[5],[6],[7],[8]{Table 1}

The methods section is the easiest to write. However, this section is most frequently responsible for rejection of the manuscript.[2] Some of the common flaws/pitfalls in writing the methods reported are: [2],[3],[6]

Inadequate description of methodologyInadequate explanation of the study design/experimental conditionsInsufficient information about the patient populationInappropriate statistical testsMixing results with the methods.

These errors could be minimized by (a) logically organizing relevant details of methods described in the protocol,[6] (b) following relevant reporting guidelines, for example, Consolidated Standards of Reporting Trials (CONSORT) or Strengthening the Reporting of Observational Studies in Epidemiology (STROBE),[7],[8] and (c) providing sufficient details to allow replication of the study.[6]

 Results



The purpose of the results section is to inform readers about important observations of the study.

Some of the common flaws reported in this section are: [2],[3],[9],[10]

Illogical sequence of data presentationInadequate, unoriginal, predictable, or trivial resultsInappropriate or inaccurate dataErrors in data analysisImproper statistical tests/analysisReporting observations of parameters that have not been included in the methods sectionNot reporting observations of experiments that have been included in the methods sectionFailure to report data pertaining to the primary objectiveDescribing conclusions or interpretation of the studyMixing results and methods.

Errors in presentation of data are:

Repetition of data in text, tables, and graphsInappropriate presentation of data[11],[12],[13]Tables – not cited in the text, data discrepancy between tables and text, inaccuracy in numbers/totalsGraphs – wrong type, lack of legend or data labels, not plotted to scale, misuse of three dimensionsFigures – annotations small/illegibleImages – identity of patients/participants not masked, technical and resolution problems.

The most important step in writing the results is to decide which data are relevant to the research question and are essential to present and which data need not be presented.[9],[10]

The presentation of data should be as per the reporting guidelines.

STROBE guidelines: [7] Reporting of observational epidemiological studies requires (1) participant flow, preferably depicted in a diagram, (2) descriptive data, (3) outcome data, (4) main results, and (5) other analysesCONSORT guidelines: [8] Reporting of randomized control trials requires description of (1) participant flow, preferably depicted in a diagram, (2) recruitment, (3) baseline data, (4) numbers analyzed, (5) outcomes and estimations, and (6) ancillary analyses.

A systematic, logical, and sequential approach in writing results can help the authors in avoiding common errors.

 Discussion



The discussion section is the most important section as it describes the importance of study findings, and puts them in appropriate perspective, and describes the significance of the study.[14] However, it is the most difficult section to compose as it requires logical thinking, while other sections require orderly and logical writing.[14] Hence, major flaws in writing this section are common.

Some of these are: [2],[3],[7],[14],[15]

Conclusions not supported by dataConfounding factors not consideredOverstating the importance or generalizability of the resultsIncomplete or biased assessments of the results and their implicationsIncorrect interpretation of the resultsAvoiding discussion on unexpected findingsInadequate discussion – recent articles/evidence not discussedWrong conclusionsInsufficient discussion of limitationsDiscussing results not reportedDescribing/repeating results in detailRepeating information from introductionOmission of important and relevant referencesInterpretation too long, meandering, or verbose.

The authors should plan and compose the discussion by having a well-thought focused approach. The authors can adapt the following approach for writing components of the discussion section: [5],[7],[8],[14],[15]

Key results

Give summary of the main findings with respect to study objectivesEmphasize new and important findingsExplore probable mechanisms of the findings.

Interpretation of results

Give cautious overall interpretation considering objectives and limitationsCompare and contrast the findings and interpretations with major, relevant, and currently published evidenceIdentify and explain conflicting, contradicting, or unexpected findings.

Limitations of the study

Sources of imprecisionPotential bias due to confounding variables.

Generalizability (external validity) of results

Explain the implications of the study findings in the context of the totality of the relevant evidenceExplore the implications of the findings for future research or clinical practice or policyProvide a concise conclusion.

 Introduction



The purpose of the introduction is to provide scientific background and explanation of rationale and state-specific objectives or hypotheses.[7],[8] This section should allow researchers or readers to understand the study's context and evaluate its potential contribution to current scientific knowledge.[7] The authors should avoid mistakes of (1) providing an exhaustive literature review and critique of previous work, (2) not describing the hypothesis with clarity, (3) describing data or conclusions, (4) extensive citation of references, and (5) writing a lengthy introduction.[2],[5],[16],[17]

 Other errors



The authors should pay attention to other aspects of manuscript preparation which can lead to revision or rejection.

Length – Most journals publish around 3000 words for IMRAD sections and up to 3–4 tables and figures. According to a recent analysis by Heßler et al., major medical journals publish 30 paragraphs divided into introduction 3, methods 10, results 9, and discussion 8 paragraphs.[18] Long discussion and introduction and many tables/figures may invite revision of the manuscript.Language – poor grammatical writing and poor flow of ideas.Abstract – As the abstract is the only section of the main article indexed in many electronic databases, and the only content most readers browse, the authors should ensure that it accurately reflects the content of the article.[5]

After submission of manuscript

Editorial review and peer review are the important processes after submission of the manuscript.

Editorial review process

The editorial team takes initial decision about the acceptability of the manuscript for further processing. This decision is based on whether (1) the manuscript fits into the scope of the journal, (2) the manuscript complies with the style and instructions to authors, (3) the study is original or novel, (4) the study is ethical, (5) there is plagiarism, and (6) the manuscript presentation and write-up are of good quality. The decision could be – rejection, revision, or referral for peer review. Majority of original articles – over 70% – may be rejected during the editorial review.[3] The most common reasons for rejection are out of scope, lack of originality, inappropriate study methods/design, ethical issues, and poor language/presentation.[3]

Peer review process

Peer review process is the indispensable time-tested quality control mechanism integral to science for the assessment of manuscripts submitted to journals by experts who are unbiased and independent.[3],[5],[19] During this process, reviewers critically evaluate the manuscript for: [19]

Relevance of the study to readersImportance and novelty of the manuscriptValidity of the researchStrengths and weaknesses of the methodsImportant missing and/or inaccurate informationGeneralizability of findingsInterpretation of resultsImportant limitationsClarity of presentation.

Flaws in one or more of these aspects of the manuscript are common reasons for revision or rejection of the manuscript.

Peer review process is extremely useful for the authors as reviewers conduct critical evaluation of important aspects of methods, results, or discussion and give suggestions for improvement. The authors should respond to each general and specific comment individually in an objective manner with rational arguments supported by relevant evidence. The authors should critically review major comments, for example, flaws in study design, methodology, statistical analysis, or conclusion, and reanalyze or rewrite parts of the manuscript.[20] The authors should also respond to minor comments, for example, minor clarifications, additional information on design, removal of unnecessary text, or some modification in the style.[20] The authors should indicate where and what changes are made in the manuscript and highlight the changes in track mode. The authors should resubmit the revised manuscript within time limit suggested by the journal.

Manuscript processing time

After submission of manuscript, most authors would expect a quick response from journal and rapid publication. However, they need to be aware of the time required to complete critical processes: (1) editorial review, (2) peer review, (3) technical editing (4) proof corrections and (5) author's response for revision, responding to technical edits and correcting proofs. Shah et al. analyzed publication turnaround time of 420 original articles published in 14 Indian journals and reported a combined median peer review time of 143.5 days and a median publication time of 146.5 days.[21] Manjunath et al. have reported a mean time to acceptance of 4.7–7.17 months (141–215.1 days) and a mean time to publication of 3.03–8.33 months (90.9–249.9 days) for three Indian dermatology journals.[22]

For articles published in Perspectives in Clinical Research between 2018 and 2020, the mean time to acceptance was 75.49–111.8 days and the mean time to publication was 115.61–266.61 days. The rejection rate for original articles was 73%–88%.

The speed of publication in a journal is dependent on a variety of factors – strength of the editorial team, reviewer's acceptance and timely review, number and quality of the manuscripts, responsiveness of the authors, frequency of the journal, and acceptance rate. The fact that the editorial team and the reviewers provide pro bono-free service to the journal and spare time from their own busy schedules could affect the time to acceptance. Most journals reduce time by electronic publication of accepted articles as ahead of print (AOP). However, AOP articles would appear in PubMed several weeks after they are available in electronic format on journal website and in printed hard copy format. Prospective authors, who desire rapid publication, should understand the complexity of manuscript processing, submit high-quality manuscripts, and respond to revisions rationally in a reasonable time frame.

 My Ten Commandments for Amateur Authors



Attend training in literature search, clinical research methodology, and preparation of publication.Select research question which meets FINER criteriaDesign study protocol with meticulous attention to scientific aspects.Submit the protocol and informed consent form for ethics committee review and approval.Register the study in a public clinical trial registry prior to initiation of the study.Choose a journal for publication considering quality, indexing, frequency, and peer review process.Review past issues of selected journal to understand the scope, and to scan and cite relevant articles, and to become familiar with style and format of the published articles.Develop vital skills for preparing publications – organization, analysis, synthesis, logic, etc.Prepare manuscript as per the instructions to authors, avoiding major flaws and errors.Submit the manuscript, resubmit revised manuscript, and patiently wait for acceptance and publication. If rejected, look objectively for reasons and revise for another journal.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

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