Systematic review and meta‐analysis of clinical trials examining the effect of hyperbaric oxygen therapy in people with diabetes‐related lower limb ulcers
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Abstract Aim To examine the efficacy of hyperbaric oxygen therapy in healing diabetes‐related lower limb ulcers through a meta‐analysis of randomized clinical trials. Methods A literature search was conducted to identify appropriate clinical trials. Inclusion required randomized study design and reporting of the proportion of diabetes‐related lower limb ulcers that healed. A meta‐analysis was performed to examine the effect of hyperbaric oxygen therapy on ulcer healing. The secondary outcomes were minor and major amputations. Results Nine randomized trials involving 585 participants were included. People allocated to hyperbaric oxygen therapy were more likely to have complete ulcer healing (relative risk 1.95, 95% CI 1.51–2.52; P <0.001), and less likely to require major (relative risk 0.54, 95% CI 0.36–0.81; P =0.003) or minor (relative risk 0.68, 95% CI 0.48–0.98; P =0.040) amputations than control groups. Sensitivity analyses suggested the findings were dependent on the inclusion of one trial. Adverse events included ear barotrauma and a seizure. Many of the trials were noted to have methodological weaknesses including absence of blinding of outcome assessors, lack of a justifiable sample size calculation and limited follow‐up. Conclusions This meta‐analysis suggests hyperbaric oxygen therapy improves the healing of diabetes‐related lower limb ulcers and reduces the requirement for amputation. Confidence in these results is limited by significant design weaknesses of previous trials and inconsistent findings. A more rigorous assessment of the efficacy of hyperbaric the efficacy of hyperbaric oxygen therapy is needed.Keywords:
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Abstract The objective of blinding is to contribute to the elimination of bias that may be introduced intentionally or unintentionally by the various individuals involved in a research study. Different types of bias (e.g., information bias, detection bias, etc.) can be prevented or reduced by blinding patients, health care providers, data collectors, outcome assessors, and/or data analysts. Even when patients and those administering treatment cannot be blinded (e.g., if the study involves a surgical procedure), blinding of outcome assessment can still be possible and helps reduce detection bias. Owing to ambiguity in blinding methodology (e.g., single‐blinded, double‐blinded, etc.), it is important to carefully report the blinding status of all individuals involved in a research study and the blinding mechanism. This helps the reader judge the validity of the study and ensures the credibility of its results. In order to ensure the success of blinding in preventing or reducing bias, it is important to assess its efficacy before the study begins. However, assessment of the efficacy of blinding at the end of the study might produce ambiguous results as failures in blinding are often confounded with treatment efficacy and adverse events.
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Recent studies have indicated higher risk of fractures among coffee drinkers. To quantitatively assess the association between coffee consumption and the risk of fractures, we conducted this meta-analysis.We searched MEDLINE and EMBASE for prospective studies reporting the risk of fractures with coffee consumption. Quality of included studies was assessed with the Newcastle Ottawa scale. We conducted a meta-analysis and a cumulative meta-analysis of relative risk (RR) for an increment of one cup of coffee per day, and explored the potential dose-response relationship. Sensitivity analysis was performed where statistical heterogeneity existed.We included 10 prospective studies covering 214,059 participants and 9,597 cases. There was overall 3.5% higher fracture risk for an increment of one cup of coffee per day (RR = 1.035, 95% CI: 1.019-1.052). Pooled RRs were 1.049 (95% CI: 1.022-1.077) for women and 0.910 (95% CI: 0.873-0.949) for men. Among women, RR was 1.055 (95% CI: 0.999-1.114) for younger participants, and 1.047 (95% CI: 1.016-1.080) for older ones. Cumulative meta-analysis indicated that risk estimates reached a stabilization level (RR = 1.035, 95% CI: 1.019-1.052), and it revealed a positive dose-response relationship between coffee consumption and risk of fractures either for men and women combined or women specifically.This meta-analysis suggests an overall harm of coffee intake in increasing the risk of fractures, especially for women. But current data are insufficient to reach a convincing conclusion and further research needs to be conducted.
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Blinding mitigates several sources of bias which, if left unchecked, can quantitively affect study outcomes. Blinding remains under-utilized, particularly in non-pharmaceutical clinical trials, but is often highly feasible through simple measures. Although blinding is generally viewed as an effective method by which to eliminate bias, blinding does also pose some inherent limitations, and it behooves clinicians and researchers to be aware of such caveats. This article will review general principles for blinding in clinical trials, including examples of useful blinding techniques for both pharmaceutical and non-pharmaceutical trials, while also highlighting the limitations and potential consequences of blinding. Appropriate reporting on blinding in trial protocols and manuscripts, as well as future directions for blinding research, will also be discussed.
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