Better training and more circumspection on the part of investigators, tougher editorial standards on the part of journals, and hefty skepticism on the part of referees and readers are necessary to avoid the dangers of false alarms, pseudo-epidemics, and their unfortunate consequences. Only in a properly performed randomized controlled trial, free of bias, should small associations merit attention. However, these guidelines are not foolproof: strong (yet spurious) associations can result when large amounts of bias are present. In general, unless RRs in cohort studies exceed 2 to 3 or ORs in case-control studies exceed 3 or 4, associations in observational research findings should not be considered credible. Hence, detection of small associations falls below the discriminatory ability of observational studies. All observational research has bias (which can include selection, information, and confounding bias). Such associations, commonly reported in the medical literature, are more likely to be attributable to bias than to causal association. This issue is especially problematic for weak associations, variably defined as relative risks (RRs) or odds ratios (ORs) less than 4. This credibility problem has many causes, including the failure of authors, reviewers, and editors to recognize the inherent limitations of these studies. The contraceptive efficacy of the nonlatex condoms requires more research.Most reported associations in observational clinical research are false, and the minority of associations that are true are often exaggerated. In almost all of the comparisons, substantial proportions of participants preferred the nonlatex condom or reported that they would recommend its use to others.Īlthough the nonlatex condoms were associated with higher rates of clinical breakage than their latex comparison condoms, the new condoms still provide an acceptable alternative for those with allergies, sensitivities or preferences that might prevent the consistent use of latex condoms. The statistically significant odds ratios for clinical breakage for the nonlatex condoms versus their latex comparisons ranged from 2.6 (95% CI: 1.6 to 4.3) to 5.0 (95% CI: 3.6 to 6.8). The nonlatex condoms were associated with higher rates of clinical breakage than their latex comparison condoms. While the eZ.on condom did not protect against pregnancy as well as its latex comparison condom, no differences were found in the typical-use efficacy in the comparisons between the Avanti and the Standard Tactylon and their latex counterparts. Contraceptive efficacy, early discontinuation, and safety outcomes were also measured with survival analysis techniques and entered into "Additional tables." The number of condoms, men, or women was used as the denominator for the ORs. Document Information click to expand document information. 0 ratings 0 found this document useful (0 votes) 149 views. Peto odds ratios (ORs) with 95% confidence intervals (CIs) were calculated for the outcomes contraceptive efficacy, condom breakage and slippage, discontinuation of use, safety and user preference. Grimes - Essential Concepts in Clinical Research - Randomised Controlled Trials and Observational Epidemiology-Elsevier (2018) Uploaded by ciro. We entered and analyzed data with RevMan 4.1. Researchers should spurn all systematic, non-random methods of allocation. Moreover, anything short of proper randomisation courts selection and confounding biases. However, randomisation persists as perhaps the least-understood aspect of a trial. Two reviewers independently extracted data from the identified studies. The randomised controlled trial sets the gold standard of clinical research. We evaluated all titles and abstracts located in the literature searches for inclusion in the review. The review included all randomized controlled trials identified in the literature search that evaluated a male nonlatex condom made of polyurethane film or synthetic elastomers in comparison with a latex condom. We also wrote to the manufacturers of nonlatex condoms and known investigators in an attempt to locate any other published or unpublished trials not identified in our search. The references of eligible publications were assessed for inclusion. We searched the the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE using PubMed, EMBASE, Popline, and LILACS for randomized controlled trials of nonlatex condoms. The review sought to evaluate nonlatex male condoms in comparison with latex condoms in terms of contraceptive efficacy, breakage, slippage, safety and user preferences. Beginning in the 1990s, nonlatex male condoms made of polyurethane film or synthetic elastomers were developed as alternative male barrier methods for individuals with allergies, sensitivities or preferences that prevented the consistent use of condoms made of latex. The male condom, which consists of a thin sheath placed over the glans and shaft of the penis, is designed to prevent pregnancy by providing a physical barrier against the deposition of semen into the vagina during intercourse.
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