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      A systematic review of randomised controlled trials of interventions promoting effective condom use

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          Abstract

          Background

          Effective condom use can prevent sexually transmitted infections (STIs) and unwanted pregnancy. We conducted a systematic review and methodological appraisal of randomised controlled trials (RCTs) of interventions to promote effective condom use.

          Methods

          We searched for all RCTs of interventions to promote effective condom use using the Cochrane Infectious Diseases Group's trials register (Oct 2006), CENTRAL (Issue 4, 2006), MEDLINE (1966 to Oct 2006), EMBASE (1974 to Oct 2006), LILACS (1982 to Oct 2006), IBSS (1951 to Oct 2006) and Psychinfo (1996 to Oct 2006). We extracted data on allocation sequence, allocation concealment, blinding, loss to follow-up and measures of effect. Effect estimates were calculated.

          Results

          We identified 139 trials. Seven out of ten trials reported reductions in ‘any STI’ with five statistically significant results. Three out of four trials reported reductions in pregnancy, although none was statistically significant. Only four trials met all the quality criteria. Trials reported a median of 11 (IQR 7–17) outcome measures. Few trials used the same outcome measure. Altogether, 10 trials (7%) used the outcome ‘any STI’, 4 (3%) self-reported pregnancy and 22 (16%) used ‘condom use at last sex’.

          Conclusions

          The results are generally consistent with modest benefits but there is considerable potential for bias due to poor trial quality. Because of the low proportion of trials using the same outcome the potential for bias from selective reporting of outcomes is considerable. Despite the public health importance of increasing condom use there is little reliable evidence on the effectiveness of condom promotion interventions.

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          Most cited references74

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          Systematic reviews in health care: Assessing the quality of controlled clinical trials.

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            Improving the quality of reporting of randomized controlled trials. The CONSORT statement.

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              Identifying outcome reporting bias in randomised trials on PubMed: review of publications and survey of authors.

              To examine the extent and nature of outcome reporting bias in a broad cohort of published randomised trials. Retrospective review of publications and follow up survey of authors. Cohort All journal articles of randomised trials indexed in PubMed whose primary publication appeared in December 2000. Prevalence of incompletely reported outcomes per trial; reasons for not reporting outcomes; association between completeness of reporting and statistical significance. 519 trials with 553 publications and 10,557 outcomes were identified. Survey responders (response rate 69%) provided information on unreported outcomes but were often unreliable--for 32% of those who denied the existence of such outcomes there was evidence to the contrary in their publications. On average, over 20% of the outcomes measured in a parallel group trial were incompletely reported. Within a trial, such outcomes had a higher odds of being statistically non-significant compared with fully reported outcomes (odds ratio 2.0 (95% confidence interval 1.6 to 2.7) for efficacy outcomes; 1.9 (1.1 to 3.5) for harm outcomes). The most commonly reported reasons for omitting efficacy outcomes included space constraints, lack of clinical importance, and lack of statistical significance. Incomplete reporting of outcomes within published articles of randomised trials is common and is associated with statistical non-significance. The medical literature therefore represents a selective and biased subset of study outcomes, and trial protocols should be made publicly available.
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                Author and article information

                Journal
                J Epidemiol Community Health
                jech
                jech
                Journal of Epidemiology and Community Health
                BMJ Group (BMA House, Tavistock Square, London, WC1H 9JR )
                0143-005X
                1470-2738
                12 October 2009
                February 2011
                12 October 2009
                : 65
                : 2
                : 100-110
                Affiliations
                [1 ]Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK
                [2 ]University of Cambridge, Department of Public Health and Primary Care, Cambridge, UK
                Author notes
                Correspondence to Dr Caroline Free, Nutrition and Public Health Interventions Department, Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London WC1E 7HT, UK; caroline.free@ 123456lshtm.ac.uk
                Article
                jech85456
                10.1136/jech.2008.085456
                3009845
                19822557
                cca172a5-c5ad-4005-bf5e-df5077c739ff
                © 2011, Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

                This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/2.0/ and http://creativecommons.org/licenses/by-nc/2.0/legalcode.

                History
                : 10 May 2009
                Categories
                Essay
                1506

                Public health
                sexually transdis,contraception sa,sexual behaviour,sexual health,contraception rb
                Public health
                sexually transdis, contraception sa, sexual behaviour, sexual health, contraception rb

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