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Identifying, documenting, and examining heterogeneity in systematic reviews of complex interventions
This article describes approaches for planning, dealing, and analyzing heterogeneity in a systematic review of complex interventions. Approaches aim to generate a priori hypotheses of the mechanism of action of a complex intervention to identify the key variables that might contribute to variation among studies and guide statistical analysis. In addition to characteristics related to the population, intervention, and outcomes, we describe study-related variables, such as the way the interventions have been implemented and the context and conduct of studies. These approaches will guide reviewers planning a meta-analysis and provide a rationale for not meta-analyzing data if there is too much variability. Potential difficulties in applying meta-analytical techniques to examine statistical association among study results and sources of potential heterogeneity are described; these include the selection of a fixed or random-effects model, the risk of multiple testing and confounding when studies include different aspects of a complex intervention or different subsamples of the intended participant pool. © 2013 Elsevier Inc. All rights reserved.
Alternative service models for delivery of healthcare services in high-income countries: a scoping review of systematic reviews.
INTRODUCTION: Costs associated with the delivery of healthcare services are growing at an unsustainable rate. There is a need for health systems and healthcare providers to consider the economic impacts of the service models they deliver and to determine if alternative models may lead to improved efficiencies without compromising quality of care. The aim of this protocol is to describe a scoping review of the extent, range and nature of available synthesised research on alternative delivery arrangements for health systems relevant to high-income countries published in the last 5 years. DESIGN: We will perform a scoping review of systematic reviews of trials and economic studies of alternative delivery arrangements for health systems relevant to high-income countries published on 'Pretty Darn Quick' (PDQ)-Evidence between 1 January 2012 and 20 September 2017. All English language systematic reviews will be included. The Cochrane Effective Practice and Organisation of Care taxonomy of health system interventions will be used to categorise delivery arrangements according to: how and when care is delivered, where care is provided and changes to the healthcare environment, who provides care and how the healthcare workforce is managed, co-ordination of care and management of care processes and information and communication technology systems. This work is part of a 5-year Partnership Centre for Health System Sustainability aiming to investigate and create interventions to improve health-system-performance sustainability. ETHICS AND DISSEMINATION: No primary data will be collected, so ethical approval is not required. The study findings will be published and presented at relevant conferences.
Should I stay or should I go? A retrospective propensity score matched analysis using administrative data of hospital-at-home for older people in Scotland
Objectives: To compare the characteristics of populations admitted to hospital-at-home services with the population admitted to hospital and assess the association of these services with healthcare costs and mortality. Design: In a retrospective observational cohort study of linked patient level data, we used propensity score matching in combination with regression analysis. Participants: Patients aged 65 years and older admitted to hospital-at-home or hospital. Interventions: Three geriatrician-led admission avoidance hospital-at-home services in Scotland. Outcome measures: Healthcare costs and mortality. Results: Patients in hospital-at-home were older and more socioeconomically disadvantaged, had higher rates of previous hospitalization, and there was a greater proportion of women and people with several chronic conditions compared with the population admitted to hospital. The cost of providing hospital-at-home varied between the three sites from £628 to £2928 per admission. Hospital-at-home was associated with 18% lower costs during the follow-up period in site one (ratio of means 0.82; 95%CI: 0.76-0.89). Limiting the analysis to costs during the 6 months following index discharge, patients in the hospital-at-home cohorts had 27% higher costs (ratio of means 1.27; 95%CI: 1.14-1.41) in site one, 9% (ratio of means 1.09; 95%CI: 0.95-1.24) in site two and 70% in site three (ratio of means 1.70; 95%CI: 1.40-2.07) compared with patients in the control cohorts. Admission to hospital-at-home was associated with an increased risk of death during the follow-up period in all three sites (1.09, 95%CI: 1.00-1.19 site one; 1.29, 95%CI: 1.15-1.44 site two; 1.27, 95%CI: 1.06-1.54 site three). Conclusions: Our findings indicate that in these three cohorts, the populations admitted to hospital-at-home and hospital differ. We cannot rule out the risk of residual confounding, as our analysis relied on an administrative data set and we lacked data on disease severity and type of hospitalised care received in the control cohorts.
Mobile-based technologies to support healthcare provider to healthcare provider communication and management of care
© 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To assess the effects of mobile-based technologies versus standard practice for supporting communication and client management in healthcare providers.
Mobile-based technologies to support client to healthcare provider communication and management of care
© 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To assess the effectiveness of mobile-based technologies to support communication of healthcare information and management of care, on clients' health and well-being, as well as unintended consequences and resources use, compared to standard practice.
BACKGROUND: In many countries emergency departments (EDs) are facing an increase in demand for services, long waits, and severe crowding. One response to mitigate overcrowding has been to provide primary care services alongside or within hospital EDs for patients with non-urgent problems. However, it is unknown how this impacts the quality of patient care and the utilisation of hospital resources, or if it is cost-effective. This is the first update of the original Cochrane Review published in 2012. OBJECTIVES: To assess the effects of locating primary care professionals in hospital EDs to provide care for patients with non-urgent health problems, compared with care provided by regularly scheduled emergency physicians (EPs). SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (the Cochrane Library; 2017, Issue 4), MEDLINE, Embase, CINAHL, PsycINFO, and King's Fund, from inception until 10 May 2017. We searched ClinicalTrials.gov and the WHO ICTRP for registered clinical trials, and screened reference lists of included papers and relevant systematic reviews. SELECTION CRITERIA: Randomised trials, non-randomised trials, controlled before-after studies, and interrupted time series studies that evaluated the effectiveness of introducing primary care professionals to hospital EDs attending to patients with non-urgent conditions, as compared to the care provided by regularly scheduled EPs. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. MAIN RESULTS: We identified four trials (one randomised trial and three non-randomised trials), one of which is newly identified in this update, involving a total of 11,463 patients, 16 general practitioners (GPs), 9 emergency nurse practitioners (NPs), and 69 EPs. These studies evaluated the effects of introducing GPs or emergency NPs to provide care to patients with non-urgent problems in the ED, as compared to EPs for outcomes such as resource use. The studies were conducted in Ireland, the UK, and Australia, and had an overall high or unclear risk of bias. The outcomes investigated were similar across studies, and there was considerable variation in the triage system used, the level of expertise and experience of the medical practitioners, and type of hospital (urban teaching, suburban community hospital). Main sources of funding were national or regional health authorities and a medical research funding body.There was high heterogeneity across studies, which precluded pooling data. It is uncertain whether the intervention reduces time from arrival to clinical assessment and treatment or total length of ED stay (1 study; 260 participants), admissions to hospital, diagnostic tests, treatments given, or consultations or referrals to hospital-based specialist (3 studies; 11,203 participants), as well as costs (2 studies; 9325 participants), as we assessed the evidence as being of very low-certainty for all outcomes.No data were reported on adverse events (such as ED returns and mortality). AUTHORS' CONCLUSIONS: We assessed the evidence from the four included studies as of very low-certainty overall, as the results are inconsistent and safety has not been examined. The evidence is insufficient to draw conclusions for practice or policy regarding the effectiveness and safety of care provided to non-urgent patients by GPs and NPs versus EPs in the ED to mitigate problems of overcrowding, wait times, and patient flow.
© 2013 The Cochrane Collaboration. This is the protocol for a review and there is no abstract. The objectives are as follows: To evaluate the effectiveness of implementation tools developed and disseminated by guideline producers, which accompany or follow the publication of a CPG, to promote uptake. A secondary objective is to determine which approaches to guideline implementation are most effective.
<jats:sec id="abs1-1"> <jats:title>Background</jats:title> <jats:p>The Comprehensive Geriatric Assessment (CGA) is a multidisciplinary process that determines a frail older person’s medical, functional, psychological and social capability to ensure that they have a co-ordinated plan for treatment and follow-up.</jats:p> </jats:sec> <jats:sec id="abs1-2"> <jats:title>Objectives</jats:title> <jats:p>To improve our understanding of the effectiveness, cost-effectiveness and implementation of the CGA across hospital and hospital-at-home settings.</jats:p> </jats:sec> <jats:sec id="abs1-3"> <jats:title>Methods</jats:title> <jats:p>We used a variety of methods. We updated a Cochrane review of randomised trials of the CGA in hospital for older people aged ≥ 65 years, conducted a national survey of community CGA, analysed data from three health boards using propensity score matching (PSM) and regression analysis, conducted a qualitative study and used a modified Delphi method.</jats:p> </jats:sec> <jats:sec id="abs1-4"> <jats:title>Results</jats:title> <jats:p>We included 29 trials recruiting 13,766 participants in the Cochrane review of the CGA. Older people admitted to hospital who receive the CGA are more likely to be living at home at 3–12 months’ follow-up [relative risk (RR) 1.06, 95% confidence interval (CI) 1.01 to 1.10] (high certainty). The probability that the CGA would be cost-effective at a £20,000 ceiling ratio for quality-adjusted life-years (QALYs), life-years (LYs) and LYs living at home was 0.50, 0.89, and 0.47, respectively (low-certainty evidence). After PSM and regression analysis comparing CGA hospital with CGA hospital at home, we found that the health-care cost (from admission to 6 months after discharge) in site 1 was lower in hospital at home (ratio of means 0.82, 95% CI 0.76 to 0.89), in site 2 there was little difference (ratio of means 1.00, 95% CI 0.92 to 1.09) and in site 3 it was higher (ratio of means 1.15, 95% CI 0.99 to 1.33). Six months after discharge (excluding the index admission), the ratio of means cost in site 1 was 1.27 (95% CI 1.14 to 1.41), in site 2 was 1.09 (95% CI 0.95 to 1.24) and in site 3 was 1.70 (95% CI 1.40 to 2.07). At 6 months’ follow-up (excluding the index admission), there may be an increased risk of mortality (adjusted) in the three hospital-at-home cohorts (site 1: RR 1.09, 95% CI 1.00 to 1.19; site 2: RR 1.29, 95% CI 1.15 to 1.44; site 3: RR 1.27, 95% CI 1.06 to 1.54). The qualitative research indicates the importance of relational aspects of health care, incorporating caregivers’ knowledge in care planning, and a lack of clarity about the end of an episode of health care. Core components that should be included in CGA focus on functional, physical and mental well-being, medication review and a caregiver’s ability to care.</jats:p> </jats:sec> <jats:sec id="abs1-5"> <jats:title>Limitations</jats:title> <jats:p>The risk of residual confounding limits the certainty of the findings from the PSM analysis; a second major limitation is that the research plan did not include an investigation of social care or primary care.</jats:p> </jats:sec> <jats:sec id="abs1-6"> <jats:title>Conclusions</jats:title> <jats:p>The CGA is an effective way to organise health care for older people in hospital and may lead to a small increase in costs. There may be an increase in cost and the risk of mortality in the population who received the CGA hospital at home compared with those who received the CGA in hospital; randomised evidence is required to confirm or refute this. Caregiver involvement in the CGA process could be strengthened.</jats:p> </jats:sec> <jats:sec id="abs1-7"> <jats:title>Funding</jats:title> <jats:p>The National Institute for Health Research Health Services and Delivery Research programme.</jats:p> </jats:sec>
A research and development agenda for systematic reviews that ask complex questions about complex interventions
Objectives: This article outlines a research and development agenda for systematic reviews that ask complex questions about interventions varying in degree and type of complexity. Study Design and Setting: Consensus development by key authors of articles on methodological challenges in systematic reviews of complex interventions, based on a 2-day workshop in Montebello, Canada, January 2012. Results: There is an urgent need for a more precise and consistently applied lexicon and language to disaggregate several conceptually distinct dimensions of "complexity." Selected current evidence synthesis methods have potential application in reviews where complexity is important. There is a lack of evaluation of methods to better understand the nature of complex interventions and the optimal processes of synthesizing and interpreting evidence from these systematic reviews. Gaps in methods, knowledge, and know-how exist, and there is a need for additional guidance. Conclusion: Understanding how complexity can impact on findings of systematic reviews is critical. Experience in applying methods that have been developed to facilitate this understanding is limited, and the degree to which these approaches improve the systematic review process or transparency is only partially understood. Future research should concentrate on the impact of complexity on the systematic review process and findings and on further methodological development. © 2013 Elsevier Inc. All rights reserved.
Randomized multicentre pilot study of sacubitril/valsartan versus irbesartan in patients with chronic kidney disease: United Kingdom Heart and Renal Protection (HARP)- III-rationale, trial design and baseline data.
Background: Patients with chronic kidney disease (CKD) are at risk of progression to end-stage renal disease and cardiovascular disease. Data from other populations and animal experiments suggest that neprilysin inhibition (which augments the natriuretic peptide system) may reduce these risks, but clinical trials among patients with CKD are required to test this hypothesis. Methods: UK Heart and Renal Protection III (HARP-III) is a multicentre, double-blind, randomized controlled trial comparing sacubitril/valsartan 97/103 mg two times daily (an angiotensin receptor-neprilysin inhibitor) with irbesartan 300 mg one time daily among 414 patients with CKD. Patients ≥18 years of age with an estimated glomerular filtration rate (eGFR) of ≥45 but <60 mL/min/1.73 m2 and urine albumin:creatinine ratio (uACR) >20 mg/mmol or eGFR ≥20 but <45 mL/min/1.73 m2 (regardless of uACR) were invited to be screened. Following a 4- to 7-week pre-randomization single-blind placebo run-in phase (during which any current renin-angiotensin system inhibitors were stopped), willing and eligible participants were randomly assigned either sacubitril/valsartan or irbesartan and followed-up for 12 months. The primary aim was to compare the effects of sacubitril/valsartan and irbesartan on measured GFR after 12 months of therapy. Important secondary outcomes include effects on albuminuria, change in eGFR over time and the safety and tolerability of sacubitril/valsartan in CKD. Results: Between November 2014 and January 2016, 620 patients attended a screening visit and 566 (91%) entered the pre-randomization run-in phase. Of these, 414 (73%) participants were randomized (mean age 63 years; 72% male). The mean eGFR was 34.0 mL/min/1.73 m2 and the median uACR was 58.5 mg/mmol. Conclusions: UK HARP-III will provide important information on the short-term effects of sacubitril/valsartan on renal function, tolerability and safety among patients with CKD.
Causal relationship between obesity and vitamin D status: bi-directional Mendelian randomization analysis of multiple cohorts.
BACKGROUND: Obesity is associated with vitamin D deficiency, and both are areas of active public health concern. We explored the causality and direction of the relationship between body mass index (BMI) and 25-hydroxyvitamin D [25(OH)D] using genetic markers as instrumental variables (IVs) in bi-directional Mendelian randomization (MR) analysis. METHODS AND FINDINGS: We used information from 21 adult cohorts (up to 42,024 participants) with 12 BMI-related SNPs (combined in an allelic score) to produce an instrument for BMI and four SNPs associated with 25(OH)D (combined in two allelic scores, separately for genes encoding its synthesis or metabolism) as an instrument for vitamin D. Regression estimates for the IVs (allele scores) were generated within-study and pooled by meta-analysis to generate summary effects. Associations between vitamin D scores and BMI were confirmed in the Genetic Investigation of Anthropometric Traits (GIANT) consortium (n = 123,864). Each 1 kg/m(2) higher BMI was associated with 1.15% lower 25(OH)D (p = 6.52×10⁻²⁷). The BMI allele score was associated both with BMI (p = 6.30×10⁻⁶²) and 25(OH)D (-0.06% [95% CI -0.10 to -0.02], p = 0.004) in the cohorts that underwent meta-analysis. The two vitamin D allele scores were strongly associated with 25(OH)D (p≤8.07×10⁻⁵⁷ for both scores) but not with BMI (synthesis score, p = 0.88; metabolism score, p = 0.08) in the meta-analysis. A 10% higher genetically instrumented BMI was associated with 4.2% lower 25(OH)D concentrations (IV ratio: -4.2 [95% CI -7.1 to -1.3], p = 0.005). No association was seen for genetically instrumented 25(OH)D with BMI, a finding that was confirmed using data from the GIANT consortium (p≥0.57 for both vitamin D scores). CONCLUSIONS: On the basis of a bi-directional genetic approach that limits confounding, our study suggests that a higher BMI leads to lower 25(OH)D, while any effects of lower 25(OH)D increasing BMI are likely to be small. Population level interventions to reduce BMI are expected to decrease the prevalence of vitamin D deficiency.
African Americans are disproportionately affected by type 2 diabetes (T2DM) yet few studies have examined T2DM using genome-wide association approaches in this ethnicity. The aim of this study was to identify genes associated with T2DM in the African American population. We performed a Genome Wide Association Study (GWAS) using the Affymetrix 6.0 array in 965 African-American cases with T2DM and end-stage renal disease (T2DM-ESRD) and 1029 population-based controls. The most significant SNPs (n = 550 independent loci) were genotyped in a replication cohort and 122 SNPs (n = 98 independent loci) were further tested through genotyping three additional validation cohorts followed by meta-analysis in all five cohorts totaling 3,132 cases and 3,317 controls. Twelve SNPs had evidence of association in the GWAS (P<0.0071), were directionally consistent in the Replication cohort and were associated with T2DM in subjects without nephropathy (P<0.05). Meta-analysis in all cases and controls revealed a single SNP reaching genome-wide significance (P<2.5×10(-8)). SNP rs7560163 (P = 7.0×10(-9), OR (95% CI) = 0.75 (0.67-0.84)) is located intergenically between RND3 and RBM43. Four additional loci (rs7542900, rs4659485, rs2722769 and rs7107217) were associated with T2DM (P<0.05) and reached more nominal levels of significance (P<2.5×10(-5)) in the overall analysis and may represent novel loci that contribute to T2DM. We have identified novel T2DM-susceptibility variants in the African-American population. Notably, T2DM risk was associated with the major allele and implies an interesting genetic architecture in this population. These results suggest that multiple loci underlie T2DM susceptibility in the African-American population and that these loci are distinct from those identified in other ethnic populations.
With over 2 million new cases annually, stroke is associated with the highest disability-adjusted life-years lost of any disease in China. The burden is expected to increase further as a result of population ageing, an ongoing high prevalence of risk factors (eg, hypertension), and inadequate management. Despite improved access to overall health services, the availability of specialist stroke care is variable across the country, and especially uneven in rural areas. In-hospital outcomes have improved because of a greater availability of reperfusion therapies and supportive care, but adherence to secondary prevention strategies and long-term care are inadequate. Thrombolysis and stroke units are accepted as standards of care across the world, including in China, but bleeding-risk concerns and organisational challenges hamper widespread adoption of this care in China. Despite little supporting evidence, Chinese herbal products and neuroprotective drugs are widely used, and the increased availability of neuroimaging techniques also results in overdiagnosis and overtreatment of so-called silent stroke. Future efforts should focus on providing more balanced availability of specialised stroke services across the country, enhancing evidence-based practice, and encouraging greater translational research to improve outcome of patients with stroke.
Assessement of Vascular Event Prevention and Cognitive Function Among Older Adults With Preexisting Vascular Disease or Diabetes: A Secondary Analysis of 3 Randomized Clinical Trials.
Importance: Acquisition of reliable randomized clinical trial evidence of the effects of cardiovascular interventions on cognitive decline is a priority. Objectives: To estimate the association of cognitive aging with the avoidance of vascular events in cardiovascular intervention trials and understand whether reports of nonsignificant results exclude worthwhile benefit. Design, Setting, and Participants: This secondary analysis of 3 randomized clinical trials in participants with preexisting occlusive vascular disease or diabetes included survivors to final in-trial follow-up in the Heart Protection Study (HPS), Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH), and Treatment of HDL (High-Density Lipoprotein) to Reduce the Incidence of Vascular Events (HPS2-THRIVE) trials of lipid modification for prevention of cardiovascular events. Data were collected from February 1994 through January 2013 and analyzed from January 2015 through December 2018. Exposures: Incident vascular events and diabetes and statin therapy. Main Outcomes and Measures: Cognitive function was assessed at the end of a mean (SD) of 4.9 (1.5) years of follow-up using a 14-item verbal test. Associations of the incidence of vascular events and new-onset diabetes during the trials, with cognitive function at final in-trial follow-up were estimated and expressed as years of cognitive aging (using the association of the score with age >60 years). The benefit on cognitive aging mediated through the effects of lowering low-density lipoprotein cholesterol levels on events was estimated by applying these findings to nonfatal event differences observed with statin therapy in the HPS trial. Results: Among 45 029 participants undergoing cognitive assessment, mean (SD) age was 67.9 (8.0) years; 80.7% were men. Incident stroke (n = 1197) was associated with 7.1 (95% CI, 5.7-8.5) years of cognitive aging; incident transient ischemic attack, myocardial infarction, heart failure, and new-onset diabetes were associated with 1 to 2 years of cognitive aging. In HPS, randomization to statin therapy for 5 years resulted in 2.0% of survivors avoiding a nonfatal stroke or transient ischemic attack and 2.4% avoiding a nonfatal cardiac event, which yielded an expected reduction in cognitive aging of 0.15 (95% CI, 0.11-0.19) years. With 15 926 participants undergoing cognitive assessment, HPS had 80% power to detect a 1-year (ie, 20% during the 5 years) difference in cognitive aging. Conclusions and Relevance: The expected cognitive benefits of the effects of preventive therapies on cardiovascular events during even the largest randomized clinical trials may have been too small to be detectable. Hence, nonsignificant findings may not provide good evidence of a lack of worthwhile benefit on cognitive function with prolonged use of such therapies. Trial Registration: isrctn.com and ClinicalTrials.gov Identifiers: ISRCTN48489393, ISRCTN74348595, and NCT00461630.