Systematic reviews of observational studies can be affected by biases that lead to under- or over-estimates of true intervention effects. Several tools have been reported in the literature that attempt to characterize potential bias. Our objective in this study was to determine the extent to which study-specific bias may have influenced intervention impacts on total costs of care (TCOC) in round 1 of the Health Care Innovation Awards.
We reviewed 82 statistical evaluations of innovation impacts on Medicare TCOC. We developed five risk-of-bias measures and assessed their influence on TCOC impacts using meta-regression.
The majority of evaluations used propensity score matching to create their comparison groups. One third of the non-randomized interventions were judged to have some risk of biased effects due largely to the way they recruited their treatment groups, and 35% had some degree of covariate imbalance remaining after propensity score adjustments. However, in the multivariable analysis of TCOC effects, none of the bias threats we examined (comparison group construction method, risk of bias, or degree of covariate imbalance) had a major impact on the magnitude of HCIA1 innovation effects. Evaluations using propensity score weighting produced larger but imprecise savings effects compared to propensity score matching.
Our results suggest that it is unlikely that HCIA1 TCOC effect sizes were systematically affected by the types of bias we considered. Assessing the risk of bias based on specific study design features is likely to be more useful for identifying problematic characteristics than the subjective quality ratings used by existing risk tools.

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UNASSIGNED: Improved survival rates for people with cystic fibrosis have led to increased rates of co-morbidity, of which diabetes is the most common. Cystic fibrosis related diabetes affects 19% of adolescents and up to 50% of adults, although little is known about their experiences of this co-morbidity.
UNASSIGNED: To investigate the experiences of living with and managing cystic fibrosis related diabetes among adolescents and adults.
UNASSIGNED: Systematic review and thematic analysis of qualitative evidence.
UNASSIGNED: Six studies, rated good quality, were included in the review and four main themes emerged from the data: knowledge and understanding; emotional and social impact; balancing both conditions; acceptance and adjustment. Although the main themes reflect adolescent and adult experiences, there were subtle variations in their sub-themes. Participants\' overriding story was of journeying towards acceptance and integration of cystic fibrosis related diabetes into their lives. This included their unpreparedness for the likely onset of cystic fibrosis related diabetes and their struggles to balance the competing demands of living with and managing cystic fibrosis and diabetes.
UNASSIGNED: The diagnosis of cystic fibrosis related diabetes and its incorporation into daily life is challenging for many people with cystic fibrosis. Review findings indicate opportunities for cystic fibrosis related diabetes interventions pre-diagnosis, at diagnosis, and during ongoing management, which need integrating into routine cystic fibrosis care.

OBJECTIVE: The purpose of this systematic review is to synthesize the evidence on the types of interventions that have been utilized by Indigenous Peoples living with cancer, and report on their relevance to Indigenous communities and how they align with holistic wellness.
METHODS: A systematic review with narrative synthesis was conducted.
RESULTS: The search yielded 7995 unique records; 27 studies evaluating 20 interventions were included. The majority of studies were conducted in USA, with five in Australia and one in Peru. Study designs were cross-sectional (n=13); qualitative (n=5); mixed methods (n=4); experimental (n=3); and quasi-experimental (n=2). Relevance to participating Indigenous communities was rated moderate to low. Interventions were diverse in aims, ingredients, and outcomes. Aims involved (1) supporting the healthcare journey, (2) increasing knowledge, (3) providing psychosocial support, and (4) promoting dialogue about cancer. The main ingredients of the interventions were community meetings, patient navigation, arts, and printed/online/audio materials. Participants were predominately female. Eighty-nine percent of studies showed positive influences on the outcomes evaluated. No studies addressed all four dimensions of holistic wellness (physical, mental, social, and spiritual) that are central to Indigenous health in many communities.
CONCLUSIONS: Studies we found represented a small number of Indigenous Nations and Peoples and did not meet relevance standards in their reporting of engagement with Indigenous communities. To improve the cancer survivorship journey, we need interventions that are relevant, culturally safe and effective, and honoring the diverse conceptualizations of health and wellness among Indigenous Peoples around the world.

Racism towards Black, Indigenous and people of colour continues to exist in the healthcare system. This leads to profound harm for people who use and work within these settings. This is a scoping review to identify anti-racism interventions in outpatient healthcare settings. Searching the peer-reviewed and grey literature, articles were screened for inclusion by at least two independent reviewers. Synthesizing the socio-ecological levels of interventions with inductively identifying themes, a conceptual model for implementing anti-racism interventions in healthcare settings is presented. In total, 37 peer-reviewed articles were included in the review, with 12 empirical studies and 25 theoretical or conceptual papers. Six grey literature documents were also included. Healthcare institutions need to incorporate an explicit, shared language of anti-racism. Anti-racism action should incorporate leadership buy-in and commitment with dedicated resources, support and funding; a multi-level approach beginning with policy and organizational interventions; transparent accountability mechanisms for sustainable change; long-term meaningful partnerships with Black, Indigenous, and people of colour (i.e., racialized communities); and ongoing, mandatory, tailored staff education and training. Decision-makers and staff in healthcare settings have a responsibility to take anti-racism action and may improve the success and sustainability of their efforts by incorporating the foundational principles and strategies identified in this paper.

The Institute for Clinical and Economic Review (ICER) in the United States recently published a 2020 update to its value assessment framework. We are commenting on the method by which the benefits of health interventions are integrated, relating to contextual considerations and other factors relevant to an intervention\'s value. We start by discussing the theoretical foundations of decision analysis and its extension to multiple criteria decision analysis (MCDA). Then we provide a detailed, evidence-based response to some of the claims made by ICER with regard to the use of MCDA methods and stakeholder engagement. Finally, we provide a number of recommendations on the use of quantitative decision analysis and decision conferencing that could be of relevance to the ICER methodology. Overall, we agree that some of the proposed changes by ICER are moving in the right direction toward improving transparency in the value assessment process, but these changes are probably inadequate. We advocate that more serious attention should be paid to the use of quantitative decision analysis together with decision conferencing for the construction of value preferences via group processes for the integration of an intervention\'s various benefit components.

Overviews of reviews (i.e., overviews) compile information from multiple systematic reviews to provide a single synthesis of relevant evidence for healthcare decision-making. Despite their increasing popularity, there are currently no systematically developed reporting guidelines for overviews. This is problematic because the reporting of published overviews varies considerably and is often substandard. Our objective is to use explicit, systematic, and transparent methods to develop an evidence-based and agreement-based reporting guideline for overviews of reviews of healthcare interventions (PRIOR, Preferred Reporting Items for Overviews of Reviews).
We will develop the PRIOR reporting guideline in four stages, using established methods for developing reporting guidelines in health research. First, we will establish an international and multidisciplinary expert advisory board that will oversee the conduct of the project and provide methodological support. Second, we will use the results of comprehensive literature reviews to develop a list of prospective checklist items for the reporting guideline. Third, we will use a modified Delphi exercise to achieve a high level of expert agreement on the list of items to be included in the PRIOR reporting guideline. We will identify and recruit a group of up to 100 international experts who will provide input into the guideline in three Delphi rounds: the first two rounds will occur via online survey, and the third round will occur during a smaller (8 to 10 participants) in-person meeting that will use a nominal group technique. Fourth, we will produce and publish the PRIOR reporting guideline.
A systematically developed reporting guideline for overviews could help to improve the accuracy, completeness, and transparency of overviews. This, in turn, could help maximize the value and impact of overviews by allowing more efficient interpretation and use of their research findings.

The numbers of acquired brain injury (ABI) survivors in South Africa are increasing; however, facilities to provide neuropsychological rehabilitation are limited due to a lack of healthcare resources. The updated International Classification of Health, Functioning, and Disability (ICF) from the WHO emphasises how the context of an impairment influences the patient\'s activity limitations and participation restrictions. This analysis examined South African contextual influences on the accessibility, quality and efficiency of neuropsychological rehabilitation interventions after ABI in South Africa. Three main contextual influences were identified, namely, socioeconomic disparities, sociocultural influences and discharge to underprepared communities. Systems thinking and inclusive models of healthcare are needed in low-income and middle-income countries, such as South Africa, where resource constraints necessitate creative and ecological forms of rehabilitation interventions after ABI. Contextual influences are vital to consider when designing neuropsychological rehabilitation interventions in order to improve the accessibility and relevance of these interventions and to ensure the effective utilisation of scarce healthcare resources.

Randomised controlled trials (RCTs) are considered the gold standard when evaluating the causal effects of healthcare interventions. When RCTs cannot be used (e.g. ethically difficult), the interrupted time series (ITS) design is a possible alternative. ITS is one of the strongest quasi-experimental designs. The aim of this methodological study was to describe how ITS designs were being used, the design characteristics, and reporting in the healthcare setting.
We searched MEDLINE for reports of ITS designs published in 2015 which had a minimum of two data points collected pre-intervention and one post-intervention. There was no restriction on participants, language of study, or type of outcome. Data were summarised using appropriate summary statistics.
One hundred and sixteen studies were included in the study. Interventions evaluated were mainly programs 41 (35%) and policies 32 (28%). Data were usually collected at monthly intervals, 74 (64%). Of the 115 studies that reported an analysis, the most common method was segmented regression (78%), 55% considered autocorrelation, and only seven reported a sample size calculation. Estimation of intervention effects were reported as change in slope (84%) and change in level (70%) and 21% reported long-term change in levels.
This methodological study identified problems in the reporting of design features and results of ITS studies, and highlights the need for future work in the development of formal reporting guidelines and methodological work.