2001•Zhongguo xunzheng yixue zazhiRequires access

Analysis of randomized controlled trials on otorhinolaryngologic diseases in China

Chuanyu Liang

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Abstract

Objective To evaluate the quality of randomized controlled trials in otorhinolarvngology in China and provide 10 comprehend the possihility of its contribution in providing reliable evidence in clinical practice; thus providing evidence to elevate the clinical treatment level. Methods Five Chinese clinical otorhinolaryngology journals were searched and randomized controlled trials were identified and analysed according to the standards of evidence-based medicine. Results Two hundred and eighty seven issues were referred to and eighty-one randomized controlled trials were identified and analysed. Of these randomized controlled trials, 34.57% (28/81 ) had definite diagnostic standards, 38.27% (31/81 ) had inclusion standards and 33.33% (27/81) had exclusion standards ; only 1 .23% (1/81) got the approval of the participants; 40.74% (33/81 ) had moderate sample size; 3.70% (3/81) had large sample size and no one mentioned sample size estimation;81 .48% (66/81 ) didn't report the method of randomization and 38.27% (31/81 ) had baseline comparison; 18.52% (15/81 ) didn' t define the control interventions and 8.64% (7/81) even didn' t explicate the experimental intcrventions-,32.10%(26/81) used blank comparison-, 86.42 %( 70/81 ) didn't use blindness; 37 .04% (30/81) didn't mention the adverse effects; 23.46% (19/81) used accredited standards to evaluate the outcomes; 11.11% (9/81) mentioned the loss of participants and only 1 .23% (1 /81) treated the loss with statistics methods. Conclusions The quantity and quality of the otorhinolaryngologic randomized controlled trials in present review can not meet the clinical need. Higher quality of randomized controlled trials are required to improve the level of prevention and the treatment of otorhinolaryngologic diseases.

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What this paper is about

Objective To evaluate the quality of randomized controlled trials in otorhinolarvngology in China and provide 10 comprehend the possihility of its contribution in providing reliable evidence in clinical practice; thus providing evidence to elevate the clinical treatment level. Methods Five Chinese clinical otorhinolaryngology journals were searched and randomized controlled trials were identified and analysed according to the standards of evidence-based medicine. Results Two hundred and eighty seven issues were referred to and eighty-one randomized controlled trials were identified and analysed. Of these randomized controlled trials, 34.57% (28/81 ) had definite diagnostic standards, 38.27% (31/81 ) had inclusion standards and 33.33% (27/81) had exclusion standards ; only 1 .23% (1/81) got the approval of the participants; 40.74% (33/81 ) had moderate sample size; 3.70% (3/81) had large sample size and no one mentioned sample size estimation;81 .48% (66/81 ) didn't report the method of randomization and 38.27% (31/81 ) had baseline comparison; 18.52% (15/81 ) didn' t define the control interventions and 8.64% (7/81) even didn' t explicate the experimental intcrventions-,32.10%(26/81) used blank comparison-, 86.42 %( 70/81 ) didn't use blindness; 37 .04% (30/81) didn't mention the adverse effects; 23.46% (19/81) used accredited standards to evaluate the outcomes; 11.11% (9/81) mentioned the loss of participants and only 1 .23% (1 /81) treated the loss with statistics methods. Conclusions The quantity and quality of the otorhinolaryngologic randomized controlled trials in present review can not meet the clinical need. Higher quality of randomized controlled trials are required to improve the level of prevention and the treatment of otorhinolaryngologic diseases.

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Available abstract

Objective To evaluate the quality of randomized controlled trials in otorhinolarvngology in China and provide 10 comprehend the possihility of its contribution in providing reliable evidence in clinical practice; thus providing evidence to elevate the clinical treatment level. Methods Five Chinese clinical otorhinolaryngology journals were searched and randomized controlled trials were identified and analysed according to the standards of evidence-based medicine. Results Two hundred and eighty seven issues were referred to and eighty-one randomized controlled trials were identified and analysed. Of these randomized controlled trials, 34.57% (28/81 ) had definite diagnostic standards, 38.27% (31/81 ) had inclusion standards and 33.33% (27/81) had exclusion standards ; only 1 .23% (1/81) got the approval of the participants; 40.74% (33/81 ) had moderate sample size; 3.70% (3/81) had large sample size and no one mentioned sample size estimation;81 .48% (66/81 ) didn't report the method of randomization and 38.27% (31/81 ) had baseline comparison; 18.52% (15/81 ) didn' t define the control interventions and 8.64% (7/81) even didn' t explicate the experimental intcrventions-,32.10%(26/81) used blank comparison-, 86.42 %( 70/81 ) didn't use blindness; 37 .04% (30/81) didn't mention the adverse effects; 23.46% (19/81) used accredited standards to evaluate the outcomes; 11.11% (9/81) mentioned the loss of participants and only 1 .23% (1 /81) treated the loss with statistics methods. Conclusions The quantity and quality of the otorhinolaryngologic randomized controlled trials in present review can not meet the clinical need. Higher quality of randomized controlled trials are required to improve the level of prevention and the treatment of otorhinolaryngologic diseases.

Key concepts: Randomized controlled trial, Medicine, Sample size determination, Randomization, Otorhinolaryngology, Blinding, Clinical trial, Inclusion and exclusion criteria

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