Effectiveness of quality improvement strategies for coordination of care to reduce use of health care services: a systematic review and meta-analysis.

BACKGROUND: Frequent users of health care services are a relatively small group of patients who account for a disproportionately large amount of health care utilization. We conducted a meta-analysis of the effectiveness of interventions to improve the coordination of care to reduce health care utilization in this patient group. METHODS: We searched MEDLINE, Embase and the Cochrane Library from inception until May 2014 for randomized clinical trials (RCTs) assessing quality improvement strategies for the coordination of care of frequent users of the health care system. Articles were screened, and data abstracted and appraised for quality by 2 reviewers, independently. Random effects meta-analyses were conducted. RESULTS: We identified 36 RCTs and 14 companion reports (total 7494 patients). Significantly fewer patients in the intervention group than in the control group were admitted to hospital (relative risk [RR] 0.81, 95% confidence interval [CI] 0.72-0.91). In subgroup analyses, a similar effect was observed among patients with chronic medical conditions other than mental illness, but not among patients with mental illness. In addition, significantly fewer patients 65 years and older in the intervention group than in the control group visited emergency departments (RR 0.69, 95% CI 0.54-0.89). INTERPRETATION: We found that quality improvement strategies for coordination of care reduced hospital admissions among patients with chronic conditions other than mental illness and reduced emergency department visits among older patients. Our results may help clinicians and policy-makers reduce utilization through the use of strategies that target the system (team changes, case management) and the patient (promotion of self-management).

Value of information methods for assessing a new diagnostic test.

Value-of-information methods are applied to assess the evidence in support of a new diagnostic test and, where the evidence is insufficient for decision making, to determine the optimal sample size for future studies. Net benefit formulations are derived under various diagnostic and treatment scenarios. The expressions for the expected opportunity loss of adopting strategies that include the new test are given. Expressions for the expected value of information from future studies are derived. One-sample and two-sample designs, with or without known prevalence, are considered. An example is given.

Determining optimal sample sizes for multistage adaptive randomized clinical trials from an industry perspective using value of information methods.

BACKGROUND: Most often, sample size determinations for randomized clinical trials are based on frequentist approaches that depend on somewhat arbitrarily chosen factors, such as type I and II error probabilities and the smallest clinically important difference. As an alternative, many authors have proposed decision-theoretic (full Bayesian) approaches, often referred to as value of information methods that attempt to determine the sample size that maximizes the difference between the trial's expected utility and its expected cost, referred to as the expected net gain. Taking an industry perspective, Willan proposes a solution in which the trial's utility is the increase in expected profit. Furthermore, Willan and Kowgier, taking a societal perspective, show that multistage designs can increase expected net gain. PURPOSE: The purpose of this article is to determine the optimal sample size using value of information methods for industry-based, multistage adaptive randomized clinical trials, and to demonstrate the increase in expected net gain realized. At the end of each stage, the trial's sponsor must decide between three actions: continue to the next stage, stop the trial and seek regulatory approval, or stop the trial and abandon the drug. METHODS: A model for expected total profit is proposed that includes consideration of per-patient profit, disease incidence, time horizon, trial duration, market share, and the relationship between trial results and probability of regulatory approval. The proposed method is extended to include multistage designs with a solution provided for a two-stage design. An example is given. RESULTS: Significant increases in the expected net gain are realized by using multistage designs. LIMITATIONS: The complexity of the solutions increases with the number of stages, although far simpler near-optimal solutions exist. The method relies on the central limit theorem, assuming that the sample size is sufficiently large so that the relevant statistics are normally distributed. CONCLUSION: From a value of information perspective, the use of multistage designs in industry trials leads to significant gains in the expected net gain.

Cost-effectiveness of compression technologies for evidence-informed leg ulcer care: results from the Canadian Bandaging Trial.

BACKGROUND: Venous leg ulcers, affecting approximately 1% of the population, are costly to manage due to poor healing and high recurrence rates. We evaluated an evidence-informed leg ulcer care protocol with two frequently used high compression systems: 'four-layer bandage' (4LB) and 'short-stretch bandage' (SSB). METHODS: We conducted a cost-effectiveness analysis using individual patient data from the Canadian Bandaging Trial, a publicly funded, pragmatic, randomized trial evaluating high compression therapy with 4LB (n = 215) and SSB (n = 209) for community care of venous leg ulcers. We estimated costs (in 2009-2010 Canadian dollars) from the societal perspective and used a time horizon corresponding to each trial participant's first year. RESULTS: Relative to SSB, 4LB was associated with an average 15 ulcer-free days gained, although the 95% confidence interval [-32, 21 days] crossed zero, indicating no treatment difference; an average health benefit of 0.009 QALYs gained [-0.019, 0.037] and overall, an average cost increase of $420 [$235, $739] (due to twice as many 4LB bandages used); or equivalently, a cost of $46,667 per QALY gained. If decision makers are willing to pay from $50,000 to $100,000 per QALY, the probability of 4LB being more cost effective increased from 51% to 63%. CONCLUSIONS: Our findings differ from the emerging clinical and economic evidence that supports high compression therapy with 4LB, and therefore suggest another perspective on high compression practice, namely when delivered by trained registered nurses using an evidence-informed protocol, both 4LB and SSB systems offer comparable effectiveness and value for money.

Efficacy of cognitive enhancers for Alzheimer's disease: protocol for a systematic review and network meta-analysis.

BACKGROUND: Approximately 35 million people world-wide have Alzheimer's disease and this is projected to nearly double by 2030. Cognitive enhancers, including cholinesterase inhibitors (for example, donepezil, galantamine and rivastigmine) and memantine (N-methyl-D-aspartic acid (NMDA) receptor antagonist) have been approved for the treatment of Alzheimer's disease in many countries. Our objective is to evaluate the comparative effectiveness, safety, and cost of cognitive enhancers for Alzheimer's disease through a systematic review. METHODS/DESIGN: Studies examining the efficacy, safety, and cost of cognitive enhancers compared to placebo, supportive care, and other cognitive enhancers for Alzheimer's patients will be included. The primary outcome is cognition and secondary outcomes include function, behavior, quality of life, safety, and cost. Experimental studies (randomized controlled trials, quasi-randomized controlled trials, controlled clinical trials), quasi-experimental studies (controlled before-after, interrupted time series), and observational studies (cohort, case-control studies) will be eligible for inclusion. Inclusion will not be limited by publication status, time period or language of dissemination.We will search electronic databases (for example, MEDLINE, Cochrane Central Register of Controlled Trials, EMBASE, CINAHL, Ageline) from inception onwards. The electronic database search will be supplemented by searching for grey literature (for example, conference proceedings, searches in Google and relevant organization websites). Two reviewers will independently screen the studies for inclusion using the eligibility criteria established a priori and independently extract data. Risk of bias will be assessed using the Cochrane Risk of Bias tool for experimental and quasi-experimental studies and the Newcastle Ottawa Scale for observational studies. If deemed appropriate, meta-analysis and network (that is, indirect comparisons) meta-analysis will be conducted. DISCUSSION: Our systematic review will inform the decision of healthcare providers, policy-makers, Alzheimer's patients and family members about the use of cognitive enhancers, by improving their understanding of the costs, benefits and harms that are associated with these agents. PROSPERO REGISTRY NUMBER: CRD42012001948.

Use of a catalytic model to estimate hepatitis A incidence in a low-endemicity country: implications for modeling immunization policies.

BACKGROUND: Evaluating the cost-effectiveness of vaccine programs with dynamic modeling requires accurate estimates of incidence over time. Because infectious diseases are often underreported, supplementary data and statistical analyses are required to estimate true incidence. This study estimates the true incidence of hepatitis A virus (HAV) infection in Canada using a catalytic model. METHODS: A catalytic model was used to reconcile HAV seroprevalence data with the corresponding true cumulative risk of infection estimated from incidence data. RESULTS: The average annual reported incidence was 6.2 cases per 100,000 from 1980 to 1989 and 7.7/100,000 from 1990 to 1999, indicating that Canada is a low-incidence country. The seroprevalence in Canadian-born individuals (n = 7 studies) was approximately 1%-8% in ages <20, 1%-11% in ages 20-29, 7%-29% in ages 30-39, and higher in older age groups. Between 1980 and 1995, the catalytic model estimated an average annual incidence of 60/100,000 (95% confidence interval, 33-524); approximately 7.73 (4.21-67.33) times the average annual reported incidence of 7.78/100,000. For a typical birth cohort of 403 434 Canadians born in 1990, the model predicted 32 750 HAV cases by age 39, with a corresponding seroprevalence of approximately 8.12% by the year 2029. IMPLICATIONS: Reliable estimates of true incidence of infectious disease are required for cost-effectiveness analysis of infectious disease programs. Catalytic models enable the synthesis of dispersed data, quantification of data limitations, and reconciliation of these limitations to estimate true incidence for economic evaluations.