Adherence of randomized trials within children's surgical specialties published during 2000 to 2009 to standard reporting guidelines

Martin L. Blakely, Lillian S. Kao, Kuojen Tsao, Eunice Y. Huang, Anthony Tsai, Stacy Tanaka, Shiraz Younas, Zengqi Lu, Kevin P. Lally

Research output: Contribution to journalArticle

10 Citations (Scopus)

Abstract

Background Randomized clinical trials (RCTs) are uncommon in pediatric surgical specialties and the quality of reporting is unknown. Our primary purpose was to analyze published surgical RCTs involving children to measure adherence to the Consolidated Standards of Reporting Trials (CONSORT) guidelines. Study Design Published RCTs from January 1, 2000 through December 31, 2009 were reviewed. The trials were evaluated for the presence of 7 CONSORT guidelines and also graded according to the Jadad scale. Results Two hundred and twenty-eight trials were included. Five trials met all 7 CONSORT criteria (2%) and 53 had a Jadad score of ≥3 (23%). Slightly more than 50% of all trials specified primary outcomes and <25% described power calculations according to CONSORT. Adherence to CONSORT guidelines for allocation concealment, randomization description, and attrition details was even lower. There were significant differences between surgical specialties with regard to CONSORT adherence to the majority of the guidelines. Pediatric general surgery had the largest number of published RCTs. Pediatric orthopaedic surgery had the highest proportion of trials with a Jadad score ≥3 (40%). Conclusions Adherence to CONSORT guidelines is low across the spectrum of children's surgical specialties, although significant differences do exist. Future RCTs in children's surgical specialties should specifically focus on areas of low adherence to reporting guidelines.

Original languageEnglish (US)
JournalJournal of the American College of Surgeons
Volume217
Issue number3
DOIs
StatePublished - Jan 1 2013

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Surgical Specialties
Guidelines
Randomized Controlled Trials
Pediatrics
Random Allocation
Orthopedics

All Science Journal Classification (ASJC) codes

  • Surgery

Cite this

Blakely, Martin L. ; Kao, Lillian S. ; Tsao, Kuojen ; Huang, Eunice Y. ; Tsai, Anthony ; Tanaka, Stacy ; Younas, Shiraz ; Lu, Zengqi ; Lally, Kevin P. / Adherence of randomized trials within children's surgical specialties published during 2000 to 2009 to standard reporting guidelines. In: Journal of the American College of Surgeons. 2013 ; Vol. 217, No. 3.
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abstract = "Background Randomized clinical trials (RCTs) are uncommon in pediatric surgical specialties and the quality of reporting is unknown. Our primary purpose was to analyze published surgical RCTs involving children to measure adherence to the Consolidated Standards of Reporting Trials (CONSORT) guidelines. Study Design Published RCTs from January 1, 2000 through December 31, 2009 were reviewed. The trials were evaluated for the presence of 7 CONSORT guidelines and also graded according to the Jadad scale. Results Two hundred and twenty-eight trials were included. Five trials met all 7 CONSORT criteria (2{\%}) and 53 had a Jadad score of ≥3 (23{\%}). Slightly more than 50{\%} of all trials specified primary outcomes and <25{\%} described power calculations according to CONSORT. Adherence to CONSORT guidelines for allocation concealment, randomization description, and attrition details was even lower. There were significant differences between surgical specialties with regard to CONSORT adherence to the majority of the guidelines. Pediatric general surgery had the largest number of published RCTs. Pediatric orthopaedic surgery had the highest proportion of trials with a Jadad score ≥3 (40{\%}). Conclusions Adherence to CONSORT guidelines is low across the spectrum of children's surgical specialties, although significant differences do exist. Future RCTs in children's surgical specialties should specifically focus on areas of low adherence to reporting guidelines.",
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Adherence of randomized trials within children's surgical specialties published during 2000 to 2009 to standard reporting guidelines. / Blakely, Martin L.; Kao, Lillian S.; Tsao, Kuojen; Huang, Eunice Y.; Tsai, Anthony; Tanaka, Stacy; Younas, Shiraz; Lu, Zengqi; Lally, Kevin P.

In: Journal of the American College of Surgeons, Vol. 217, No. 3, 01.01.2013.

Research output: Contribution to journalArticle

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T1 - Adherence of randomized trials within children's surgical specialties published during 2000 to 2009 to standard reporting guidelines

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AU - Kao, Lillian S.

AU - Tsao, Kuojen

AU - Huang, Eunice Y.

AU - Tsai, Anthony

AU - Tanaka, Stacy

AU - Younas, Shiraz

AU - Lu, Zengqi

AU - Lally, Kevin P.

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N2 - Background Randomized clinical trials (RCTs) are uncommon in pediatric surgical specialties and the quality of reporting is unknown. Our primary purpose was to analyze published surgical RCTs involving children to measure adherence to the Consolidated Standards of Reporting Trials (CONSORT) guidelines. Study Design Published RCTs from January 1, 2000 through December 31, 2009 were reviewed. The trials were evaluated for the presence of 7 CONSORT guidelines and also graded according to the Jadad scale. Results Two hundred and twenty-eight trials were included. Five trials met all 7 CONSORT criteria (2%) and 53 had a Jadad score of ≥3 (23%). Slightly more than 50% of all trials specified primary outcomes and <25% described power calculations according to CONSORT. Adherence to CONSORT guidelines for allocation concealment, randomization description, and attrition details was even lower. There were significant differences between surgical specialties with regard to CONSORT adherence to the majority of the guidelines. Pediatric general surgery had the largest number of published RCTs. Pediatric orthopaedic surgery had the highest proportion of trials with a Jadad score ≥3 (40%). Conclusions Adherence to CONSORT guidelines is low across the spectrum of children's surgical specialties, although significant differences do exist. Future RCTs in children's surgical specialties should specifically focus on areas of low adherence to reporting guidelines.

AB - Background Randomized clinical trials (RCTs) are uncommon in pediatric surgical specialties and the quality of reporting is unknown. Our primary purpose was to analyze published surgical RCTs involving children to measure adherence to the Consolidated Standards of Reporting Trials (CONSORT) guidelines. Study Design Published RCTs from January 1, 2000 through December 31, 2009 were reviewed. The trials were evaluated for the presence of 7 CONSORT guidelines and also graded according to the Jadad scale. Results Two hundred and twenty-eight trials were included. Five trials met all 7 CONSORT criteria (2%) and 53 had a Jadad score of ≥3 (23%). Slightly more than 50% of all trials specified primary outcomes and <25% described power calculations according to CONSORT. Adherence to CONSORT guidelines for allocation concealment, randomization description, and attrition details was even lower. There were significant differences between surgical specialties with regard to CONSORT adherence to the majority of the guidelines. Pediatric general surgery had the largest number of published RCTs. Pediatric orthopaedic surgery had the highest proportion of trials with a Jadad score ≥3 (40%). Conclusions Adherence to CONSORT guidelines is low across the spectrum of children's surgical specialties, although significant differences do exist. Future RCTs in children's surgical specialties should specifically focus on areas of low adherence to reporting guidelines.

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