Systematic review of methods used in meta-analyses where a primary outcome is an adverse or unintended event

addresses: Peninsula College of Medicine and Dentistry, St Luke's Campus, University of Exeter, Exeter, UK. [email protected]: PMCID: PMC3528446types: Journal Article; Research Support, Non-U.S. Gov't© 2012 Warren et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.Adverse consequences of medical interventions are a source of concern, but clinical trials may lack power to detect elevated rates of such events, while observational studies have inherent limitations. Meta-analysis allows the combination of individual studies, which can increase power and provide stronger evidence relating to adverse events. However, meta-analysis of adverse events has associated methodological challenges. The aim of this study was to systematically identify and review the methodology used in meta-analyses where a primary outcome is an adverse or unintended event, following a therapeutic intervention

Reporting bias in medical research - a narrative review

Reporting bias represents a major problem in the assessment of health care interventions. Several prominent cases have been described in the literature, for example, in the reporting of trials of antidepressants, Class I anti-arrhythmic drugs, and selective COX-2 inhibitors. The aim of this narrative review is to gain an overview of reporting bias in the medical literature, focussing on publication bias and selective outcome reporting. We explore whether these types of bias have been shown in areas beyond the well-known cases noted above, in order to gain an impression of how widespread the problem is. For this purpose, we screened relevant articles on reporting bias that had previously been obtained by the German Institute for Quality and Efficiency in Health Care in the context of its health technology assessment reports and other research work, together with the reference lists of these articles

On-Ice Functional Assessment of an Elite Ice Hockey Goaltender After Treatment for Femoroacetabular Impingement

Background: Femoroacetabular impingement (FAI) is a major cause of performance inhibition in elite-level athletes. The condition is characterized by pain, osseous abnormalities such as an increased alpha angle, and decreased range of motion at the affected hip joint. Arthroscopic surgical decompression is useful in reshaping the joint to alleviate symptoms. Functional kinematic outcomes of sport-specific movements after surgery, however, are presently unknown. Hypothesis: The ability of an ice hockey goaltender to execute sport-specific movements would improve after arthroscopic surgery. Study Design: Clinical research. Level of Evidence: Level 5. Methods: An ice hockey goaltender was evaluated after arthroscopic correction of FAI on the symptomatic hip. Passive range of motion and radiographic parameters were assessed from a computed tomography–derived 3-dimensional model. An on-ice motion capture system was also used to determine peak femoral shock and concurrent hip joint postures during the butterfly and braking movements. Results: Maximum alpha angles were 47° in the surgical and 61° in the nonsurgical hip. Internal rotation range of motion was, on average, 23° greater in the surgically corrected hip compared with contralateral. Peak shock was lower in the surgical hip by 1.39 g and 0.86 g during butterfly and braking, respectively. At peak shock, the surgical hip demonstrated increased flexion, adduction, and internal rotation for both tasks (butterfly, 6.1°, 12.3°, and 30.8°; braking, 14.8°, 19.2°, and 41.4°). Conclusion: On-ice motion capture revealed performance differences between hips after arthroscopic surgery in a hockey goaltender. Range of motion and the patient’s subjective assessment of hip function were improved in the surgical hip. While presenting as asymptomatic, it was discovered that the contralateral hip displayed measurements consistent with FAI. Therefore, consideration of preemptive treatment in a presently painless hip may be deemed beneficial for young athletes seeking a long career in sport, and future work is needed to determine the costs and benefits of such an approach. Clinical Relevance: Surgical treatment of symptomatic FAI can achieve pain relief and improved kinematics of the hip joint with athletic activities. Additional studies are necessary to determine whether improved kinematics enhance the longevity of the native hip and alter the progression of osteoarthritic changes in those with asymptomatic FAI deformity. </jats:sec

Comparison of pooled risk estimates for adverse effects from different observational study designs: Methodological overview

A diverse range of study designs (e.g. case-control or cohort) are used in the evaluation of adverse effects. We aimed to ascertain whether the risk estimates from meta-analyses of case-control studies differ from that of other study designs