Reporting of the methodological quality and ethical aspects in clinical trials published in Indian journals

Jaykaran,; Kantharia, ND; Yadav, Preeti; Deoghare, Shashank

doi:10.4103/0022-3859.74300

Cited by 12 publications

(13 citation statements)

References 7 publications

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“…[7][8][9] Except for very attempts that too with smaller samples for statistical reporting and methodological aspects of clinical trials, this issue is not adequately addressed for articles published in various Indian Medical Journals. [10][11][12] Present study aims to document use of various study designs and statistical methods used by authors in articles published in Indian Medical Journals. from these journals were analysed independently by fi rst and second author for study design and statistical methods (k = 0.85 for study design and 0.89 for statistical analysis).…”

Section: Introductionmentioning

confidence: 99%

Study design and statistical methods in Indian medical journals

Jaykaran¹,

Solanki²,

Saxena³

et al. 2011

J Pharm Negative Results

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Values are shown as frequency and percentages. Results: Majority of the published articles were based on prospective study designs (60.8%). Clinical trials were as method of study was documented in 12.5% articles. Three most common tests were t test (23.2%), Chi-square test (21.9%) and analysis of variance (ANOVA) (10.5%). However, statistical methods were not at all used by 26.2% articles. Conclusions: Knowledge regarding prospective studies and statistical methods related to contingency table, t test and ANOVA needs to be updated to the Undergraduate and Postgraduate students. Abstract Access this article online Quick Response Code: Website: www.pnrjournal.com

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Section: Introductionmentioning

confidence: 99%

Study design and statistical methods in Indian medical journals

Jaykaran¹,

Solanki²,

Saxena³

et al. 2011

J Pharm Negative Results

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“…Ethical approval by an independent or institutional review board and evidence of informed consent are considered to be important components of any research project (1). Studies in the Indian context have found that reporting of ethics of research in manuscripts is less than satisfactory, though this reporting has improved (1,2).…”

Section: Introductionmentioning

confidence: 99%

Survey of “instructions to authors” of Indian medical journals for reporting of ethics and authorship criteria

Jaykaran¹,

Yadav²,

Chavda³

et al. 2011

IJME

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This study looked at information on ethics reporting and authorship in the "instructions to authors" section of Indian medical journals. Instructions to authors in 59 Indian medical journals were examined for guidance on ethics reporting and authorship. Guidance regarding ethics was mentioned in 43 (72.8%) journals; assent from minors was mentioned in 9 (15.2%) journals; approval from an animal ethics committee was mentioned in 10 (16.9%) journals; authorship criteria were mentioned in 38 (64.5%) journals. Authorship criteria according to the International Committee of Medical Journal Editors were mentioned in 35 (59.3%) journals. Guidance regarding contributors' details was mentioned in 30 (50.8%) journals. These findings suggest that many editors of Indian medical journals must upgrade their instructions to authors to include ethical requirements.

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“…Poor quality of published article may be because of either of two main reasons – one, study might not have been conducted properly, i.e., it may be poor methodologically, underpowered, use inappropriate statistics, etc., and second, all the parameters which can help authors to check validity of results are reported adequately in the published article. [1–5]…”

Section: Introductionmentioning

confidence: 99%

Quality of Antidepressant Drugs Research Articles Published in Indian Medical Journals

Charan¹,

Saxena²,

Yadav³

et al. 2011

Indian Journal of Psychological Medicine

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Aim and Objective:Quality of methodological and statistical parameters published in various Indian Medical Journals are usually debated in terms of appropriateness. Aim of this manuscript is to analyze and validate efficacy studies on antidepressant drugs published in Indian Medical Journals regarding quality of various methodological and statistical parameters used.Materials and Methods:An in-depth review of Efficacy studies on Antidepressant published in Indian Medical Journals was conducted. Articles were retrieved from all possible sources like Published Journals, downloaded through Pubmed, MedInd, Opengate, Medknow, and Cochrane. These studies were analyzed and validated for various methodological and statistical parameters. Descriptive statistics for various parameters with confidence interval (CI) is also reported herewith.Results:Of 32 articles reviewed, primary and secondary endpoints and sample size calculation was reported in only one article (3.1%; 95% CI, 0.5 to 15.7%). Power and CI was not reported in any of the reviewed articles. Inclusion and exclusion criteria were reported in 9 (28.3%; 95% CI, 15.5 to 45.3%) articles. Information regarding randomization was mentioned in 12 (37.5%; 95% CI, 22.9 to 54.7%) articles, whereas reporting of blinding or open label status of the study was mentioned in 21 (65.6%; 95% CI, 48.3 to 79.5%) articles. Assumptions of statistical tests were not reported in any of the reviewed articles. Statistical tests were used in only 14 (43.7%; 95% CI, 28.1 to 60.6%) articles of which 70% of were inappropriate. All studies were underpowered for small and medium effect size.Conclusion:Quality of reporting of methodological and statistical aspects of antidepressant efficacy studies published in Indian medical journals are poor and hence makes difficult to conclude on issues related to validity of these studies.

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Reporting of the methodological quality and ethical aspects in clinical trials published in Indian journals

Cited by 12 publications

References 7 publications

Study design and statistical methods in Indian medical journals

Study design and statistical methods in Indian medical journals

Survey of “instructions to authors” of Indian medical journals for reporting of ethics and authorship criteria

Quality of Antidepressant Drugs Research Articles Published in Indian Medical Journals

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