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Title: Reporting randomised clinical trials of analgesics after traumatic or orthopaedic surgery is inadequate: a systematic review.
Author: Montané, Eva
Vallano Ferraz, Antonio
Vidal, Xavier
Aguilera, Cristina
Laporte, Joan-Ramon
Keywords: Assaigs clínics
Efectes secundaris dels medicaments
Cirurgia ortopèdica
Dolor postoperatori
Clinical trials
Drug side effects
Orthopedic surgery
Postoperative pain
Issue Date: 12-Jan-2010
Abstract: Background Several randomised clinical trials (RCTs) of analgesics in postoperative pain after traumatic or orthopaedic surgery (TOS) have been published, but no studies have assessed the quality of these reports. We aimed to examine the quality of reporting RCTs on analgesics for postoperative pain after TOS. Methods Reports of RCTs assessing analgesics in postoperative pain after TOS were systematically searched from electronic databases. The quality of reports was assessed using the CONSORT checklist (scoring range from 0 to 22). The quality was considered poor when scoring was 12 or lesser. The publication year and the impact factor of journals were recorded. Results A total of 92 reports of RCTs were identified and 69 (75%) scored 12 or lesser in CONSORT checklist (range 5-17). The mean (SD) CONSORT score of all reports was 10.6 (2.7). Missing CONSORT items included primary and secondary outcome measures (11%), the specific objectives and hypothesis definition (12%), the sample size calculation (12%), the dates defining the periods of recruitment (12%), the discussion of external validity of findings (14%), the allocation sequence generation (24%), and the interpretation of potential bias or imprecision of results (25%). There was a little improvement in CONSORT scores over time (r = 0.62; p < 0.001) and with impact factor of journals (r = 0.30; p < 0.001). Conclusion Quality of reporting RCTs on analgesics after TOS is poor. Reporting of those RCTs should be improved according to methodological standard checklists in the next years.
Note: Reproducció del document publicat a:
It is part of: BMC Clinical Pharmacology, 2010, vol. 10, p. 2
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ISSN: 1472-6904
Appears in Collections:Articles publicats en revistes (Patologia i Terapèutica Experimental)

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