Reporting Compliance and Factors Influencing Timeliness of Stroke-Related Trial Results on ClinicalTrials.gov.

Since 2007, research groups are mandated by the Food and Drug Administration Amendments Act (FDAAA) to report clinical trial findings to ClinicalTrials.gov within 12 months of trial completion. This observational study aims to analyze compliance data of stroke-related randomized controlled trials subject to these mandates. Using a previously published algorithm, we identified clinical trials likely to be required to adhere to FDAAA mandates (highly likely applicable clinical trials, or HLACTs) from January 2008 to February 2023. We assessed the proportion of studies that reported results within 12 months of trial completion, as well as those that reported at any point within 5 years. Additionally, we utilized Kaplan-Meier and regression analysis to explore factors associated with on-time reporting. Among 357 stroke-related HLACTs on ClinicalTrials.gov that were terminated or completed between January 1, 2008, and February 1, 2023, 59 (16.5%) reported results within 12 months, while 320 (89.6%) reported results within 5 years. Median reporting times for industry funded, other government or academic institution funded, and National Institute of Health (NIH) funded studies were 18.5 months, 22 months, and 22.5 months, respectively. Open-label studies were less likely to report results by 12 months compared to double-blinded studies (p = 0.002). Biological trials exhibited a lower probability of reporting within 5 years compared to device and/or drug trials (p = 0.007). Clinical trial registries and FDAAA mandates aim to promote accountability and transparency in health sciences research. However, regardless of their funding source, only a minority of stroke-related randomized controlled trials comply with FDAAA's 12-month result reporting mandate.

Management of work-relevant upper limb disorders: a review.

BACKGROUND: Upper limb disorders (ULDs) are clinically challenging and responsible for considerable work loss. There is a need to determine effective approaches for their management. AIM: To determine evidence-based management strategies for work-relevant ULDs and explore whether a biopsychosocial approach is appropriate. METHODS: Literature review using a best evidence synthesis. Data from articles identified through systematic searching of electronic databases and citation tracking were extracted into evidence tables. The information was synthesized into high-level evidence statements, which were ordered into themes covering classification/diagnosis, epidemiology, associations/risks and management/treatment, focusing on return to work or work retention and taking account of distinctions between non-specific complaints and specific diagnoses. RESULTS: Neither biomedical treatment nor ergonomic workplace interventions alone offer an optimal solution; rather, multimodal interventions show considerable promise, particularly for occupational outcomes. Early return to work, or work retention, is an important goal for most cases and may be facilitated, where necessary, by transitional work arrangements. The emergent evidence indicates that successful management strategies require all the players to be on side and acting in a coordinated fashion; this requires engaging employers and workers to participate. CONCLUSIONS: The biopsychosocial model applies: biological considerations should not be ignored, but psychosocial factors are more influential for occupational outcomes. Implementation of interventions that address the full range of psychosocial issues will require a cultural shift in the way the relationship between upper limb complaints and work is conceived and handled. Dissemination of evidence-based messages can contribute to the needed cultural shift.

An investigation into GPs with high patient mortality rates: a retrospective study.

BACKGROUND: As part of the work of the Shipman Inquiry, five general practitioners (GPs) in West Sussex were identified as having excessively high mortality rates. The aim of this study was to identify reasons for the higher-than-expected mortality rates of these five GPs. METHODS: A retrospective analysis was made of routine mortality and patient registration data from primary-care practices in West Sussex, and the case notes of deceased patients were reviewed. Outcome measures included standardized mortality ratios (SMRs), proportion of deaths in nursing homes, and reviewers' concordance with GP decisions to issue a death certificate. RESULTS: The high death rates were not explained by the age and sex composition of each GP's patient population. SMRs ranged from 145 to 239 (average for West Sussex = 100) and all differences from the West Sussex average were statistically significant (p <0.02). SMRs were highly correlated with the proportion of deaths occurring in nursing homes (Pearson's correlation coefficient = 0.95, p = 0.015). Analysis of 153 deceased patients' notes revealed no evidence of poor clinical practice. In 114 cases, at least one independent reviewer agreed with the decision to issue a death certificate. In the remaining 39 (25 per cent) cases, inadequate information in the patient's record explained the reviewers' uncertainty about issuing a certificate. CONCLUSION: A proportionately high registration of nursing home residents is the most likely explanation for the excessive mortality rates of these five GPs. This investigation was time-consuming and costly, and highlights the potential ramifications for primary-care organizations of introducing a national system for monitoring death rates in primary care.

How does the purchasing staff of an accident insurance organization seek information about treatment effectiveness?

OBJECTIVES: The objective is to study how the staff who purchase health care services for a large national government accident-compensation system seek information on treatment effectiveness, how they assess the quality of that information, whether they question the information sources they choose, and how familiar they are with the key concepts of evidence-based health care (EBHC). METHOD: Staff (22 out of 34) of the health purchasing division of the New Zealand Accident Compensation Corporation (NZ ACC) were interviewed using eight preformatted questions to which they could provide open and multiple answers. Responses were subsequently codified into typologies for quantitative analysis. RESULTS: Most respondents report that they assess the effectiveness of a treatment by accessing published information (nonhuman sources), by consulting others (human sources), or by both means. They assess the quality of information mostly by consulting others, and the second-highest proportion of responses state that they do not know how to evaluate the quality of information. No clear preference emerges with respect to the types of information needed to determine the effectiveness of treatments. The majority of the staff believes they can access information needed to determine treatment effectiveness through the Internet or information databases such as MEDLINE. Although most said they understand the key concepts of EBHC, only five out of twenty-two were able to accurately describe them. CONCLUSIONS: The findings suggest that there is a low level of awareness among the staff of the NZ ACC regarding the use of evidence and understanding of the key concepts of EBHC. Many surveyed staff members lack the skills or training to directly question information about effectiveness of a treatment. They have little idea of the information required to determine the effectiveness of a treatment, and the majority appears to lack the skills to evaluate the health care literature.