Quality of controlled clinical trial reporting in five leading Sri Lankan medical journals

Thanya I. Pathirana, C Abeysena

Research output: Contribution to conferencePosterResearchpeer-review

Abstract

The Consolidated Standards of Reporting Trials (CONSORT) statement and the Transparent Reporting of Evaluations with Non-randomized Designs (TREND) checklist help improve the quality of reporting of trials. Report quality is often used as a surrogate measure of methodological quality. AIMS: To assess the quality of reporting of clinical trials published in five leading Sri Lankan medical journals METHODS: Five medical journals published between 1982-2011 were hand searched for randomized (RCT) and non-randomized clinical trials (NRCT) conducted in humans. These were evaluated by two independent observers to assess them against a checklist developed based on CONSORT and TREND recommendations. Outcome measures were presence of checklist items in published reports. Results: Twenty two RCT and 16 parallel group NRCT from 160 journals were included. Out of them, Thirty six (94.7%) clearly described the objectives, 13 (34.2%) the periods of recruitment, 7(18.4%) sample size determination, 12(31.6%) the flow of participants through each stage,19 (50%) baseline demographic and clinical characteristics of each group. Twenty one (55.3%) used statistical methods to compare groups for primary outcome, 21(55.3%) effect size, 4 (10.5%) its precision. Twenty (52.6%) interpreted the results in the context of current evidence. Five (13.2%) described the generalizability of the findings. Of the 22 RCT, only one (4.5%) reported sequence generation, 3(13.6%) allocation concealment, 7(31.8%) blinding status of participants or investigators and 2(9.1%) intention to treat analysis. CONCLUSIONS: Reporting of several essential criteria of remain suboptimal. Awareness of the CONSORT and TREND statements may improve matters quality of reporting.
Original languageEnglish
Pages138
Publication statusPublished - Jul 2012
EventSri Lanka Medical Association 125th Anniversary International Medical Congress: The Global Forum of Sri Lankan Doctors - Bandaranaike Memorial International Conference Hall, Colombo, Sri Lanka
Duration: 2 Jul 20126 Jul 2012
Conference number: 125th

Conference

ConferenceSri Lanka Medical Association 125th Anniversary International Medical Congress
CountrySri Lanka
CityColombo
Period2/07/126/07/12

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Controlled Clinical Trials
Checklist
Intention to Treat Analysis
Sample Size
Research Personnel
Demography
Outcome Assessment (Health Care)
Clinical Trials
Non-Randomized Controlled Trials

Cite this

Pathirana, T. I., & Abeysena, C. (2012). Quality of controlled clinical trial reporting in five leading Sri Lankan medical journals. 138. Poster session presented at Sri Lanka Medical Association 125th Anniversary International Medical Congress, Colombo, Sri Lanka.
Pathirana, Thanya I. ; Abeysena, C. / Quality of controlled clinical trial reporting in five leading Sri Lankan medical journals. Poster session presented at Sri Lanka Medical Association 125th Anniversary International Medical Congress, Colombo, Sri Lanka.
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title = "Quality of controlled clinical trial reporting in five leading Sri Lankan medical journals",
abstract = "The Consolidated Standards of Reporting Trials (CONSORT) statement and the Transparent Reporting of Evaluations with Non-randomized Designs (TREND) checklist help improve the quality of reporting of trials. Report quality is often used as a surrogate measure of methodological quality. AIMS: To assess the quality of reporting of clinical trials published in five leading Sri Lankan medical journals METHODS: Five medical journals published between 1982-2011 were hand searched for randomized (RCT) and non-randomized clinical trials (NRCT) conducted in humans. These were evaluated by two independent observers to assess them against a checklist developed based on CONSORT and TREND recommendations. Outcome measures were presence of checklist items in published reports. Results: Twenty two RCT and 16 parallel group NRCT from 160 journals were included. Out of them, Thirty six (94.7{\%}) clearly described the objectives, 13 (34.2{\%}) the periods of recruitment, 7(18.4{\%}) sample size determination, 12(31.6{\%}) the flow of participants through each stage,19 (50{\%}) baseline demographic and clinical characteristics of each group. Twenty one (55.3{\%}) used statistical methods to compare groups for primary outcome, 21(55.3{\%}) effect size, 4 (10.5{\%}) its precision. Twenty (52.6{\%}) interpreted the results in the context of current evidence. Five (13.2{\%}) described the generalizability of the findings. Of the 22 RCT, only one (4.5{\%}) reported sequence generation, 3(13.6{\%}) allocation concealment, 7(31.8{\%}) blinding status of participants or investigators and 2(9.1{\%}) intention to treat analysis. CONCLUSIONS: Reporting of several essential criteria of remain suboptimal. Awareness of the CONSORT and TREND statements may improve matters quality of reporting.",
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Pathirana, TI & Abeysena, C 2012, 'Quality of controlled clinical trial reporting in five leading Sri Lankan medical journals' Sri Lanka Medical Association 125th Anniversary International Medical Congress, Colombo, Sri Lanka, 2/07/12 - 6/07/12, pp. 138.

Quality of controlled clinical trial reporting in five leading Sri Lankan medical journals. / Pathirana, Thanya I.; Abeysena, C.

2012. 138 Poster session presented at Sri Lanka Medical Association 125th Anniversary International Medical Congress, Colombo, Sri Lanka.

Research output: Contribution to conferencePosterResearchpeer-review

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AB - The Consolidated Standards of Reporting Trials (CONSORT) statement and the Transparent Reporting of Evaluations with Non-randomized Designs (TREND) checklist help improve the quality of reporting of trials. Report quality is often used as a surrogate measure of methodological quality. AIMS: To assess the quality of reporting of clinical trials published in five leading Sri Lankan medical journals METHODS: Five medical journals published between 1982-2011 were hand searched for randomized (RCT) and non-randomized clinical trials (NRCT) conducted in humans. These were evaluated by two independent observers to assess them against a checklist developed based on CONSORT and TREND recommendations. Outcome measures were presence of checklist items in published reports. Results: Twenty two RCT and 16 parallel group NRCT from 160 journals were included. Out of them, Thirty six (94.7%) clearly described the objectives, 13 (34.2%) the periods of recruitment, 7(18.4%) sample size determination, 12(31.6%) the flow of participants through each stage,19 (50%) baseline demographic and clinical characteristics of each group. Twenty one (55.3%) used statistical methods to compare groups for primary outcome, 21(55.3%) effect size, 4 (10.5%) its precision. Twenty (52.6%) interpreted the results in the context of current evidence. Five (13.2%) described the generalizability of the findings. Of the 22 RCT, only one (4.5%) reported sequence generation, 3(13.6%) allocation concealment, 7(31.8%) blinding status of participants or investigators and 2(9.1%) intention to treat analysis. CONCLUSIONS: Reporting of several essential criteria of remain suboptimal. Awareness of the CONSORT and TREND statements may improve matters quality of reporting.

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Pathirana TI, Abeysena C. Quality of controlled clinical trial reporting in five leading Sri Lankan medical journals. 2012. Poster session presented at Sri Lanka Medical Association 125th Anniversary International Medical Congress, Colombo, Sri Lanka.