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Quality of randomized control trials and pilot trials in osteopathy according to the CONSORT checklist

Journal: Journal of Complementary and Integrative Medicine Date: 2018/12, 15(4):Pages: eA16. doi: Subito , type of study: systematic review

Free full text   (https://www.degruyter.com/document/doi/10.1515/jcim-2018-2000/html)

Keywords:

research [332]
study quality [1]
systematic review [303]

Abstract:

Background: Lack of scientific evidence is a reason frequently evoked for minimizing the potential contribution of complementary approaches. Even though the number of empirical publications in osteopathy have increased exponentially since 1980, little information is available on their quality of report. Objectives: This study assessed quality of randomized control trials (RCT) and pilot trials identified through a systematic review of osteopathy-related trial publications. Methods: Combinations of relevant keywords were searched for in CINAHL and Medline databases from 1980 to 2017. Published RCT or pilot trials describing an osteopathic intervention were included. Quality was assessed using the CONSORT checklist (CONsolidated Standards Of Reporting Trials) or its extension for pilot trials. Results: One hundred thirteen RCT and 46 pilot trials were examined; 55% concerned musculoskeletal, 25% cranial, 14% visceral, and 6% combined treatments. On average, studies reported on 16 (IQR 9-28) items on the checklist. Less than half of the studies mentioned randomized trial (48%) or pilot (26%) in their title. Specific objectives were described appropriately for all RCT but only 54% of pilot trials. The method section was generally of good quality, except for the type of trial design description (25%), sample size calculation (40%), type of and implementation of the random allocation sequence (35%), and participant enrolment procedures (15%). Forty-five percent of the studies mentioned presence/absence of harms. The majority of the studies discussed their limitations (81%), but only 1/3 discussed the generalizability of the findings. Conclusions: The quality of osteopathy-related RCT and pilot trial publications is similar to what was found for conventional medicine and other complementary medicine therapy studies. Objectives and discussion of pilot trials should reflect further the exploratory nature of such study design. Efforts are still required to increase the quality of report for the description of the randomisation technique, harms or unintended effects (or absence of), and the generalizability of the findings.


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