Roberta Wines

Interventions to Improve Adherence to Self-administered Medications for Chronic Diseases in the United States: A Systematic Review

BACKGROUND Suboptimum medication adherence is common in the United States and leads to serious negative health consequences but may respond to intervention. PURPOSE To assess the comparative effectiveness of patient, provider, systems, and policy interventions that aim to improve medication adherence for chronic health conditions in the United States. DATA SOURCES Eligible peer-reviewed publications from MEDLINE and the Cochrane Library indexed through 4 June 2012 and additional studies from reference lists and technical experts. STUDY SELECTION Randomized, controlled trials of patient, provider, or systems interventions to improve adherence to long-term medications and nonrandomized studies of policy interventions to improve medication adherence. DATA EXTRACTION Two investigators independently selected, extracted data from, and rated the risk of bias of relevant studies. DATA SYNTHESIS The evidence was synthesized separately for each clinical condition; within each condition, the type of intervention was synthesized. Two reviewers graded the strength of evidence by using established criteria. From 4124 eligible abstracts, 62 trials of patient-, provider-, or systems-level interventions evaluated 18 types of interventions; another 4 observational studies and 1 trial of policy interventions evaluated the effect of reduced medication copayments or improved prescription drug coverage. Clinical conditions amenable to multiple approaches to improving adherence include hypertension, heart failure, depression, and asthma. Interventions that improve adherence across multiple clinical conditions include policy interventions to reduce copayments or improve prescription drug coverage, systems interventions to offer case management, and patient-level educational interventions with behavioral support. LIMITATIONS Studies were limited to adults with chronic conditions (excluding HIV, AIDS, severe mental illness, and substance abuse) in the United States. Clinical and methodological heterogeneity hindered quantitative data pooling. CONCLUSION Reduced out-of-pocket expenses, case management, and patient education with behavioral support all improved medication adherence for more than 1 condition. Evidence is limited on whether these approaches are broadly applicable or affect longterm medication adherence and health outcomes. PRIMARY FUNDING SOURCE Agency for Healthcare Research and Quality.

Saxagliptin and sitagliptin in adult patients with type 2 diabetes: A systematic review and meta-analysis

The objective of this study is to compare the efficacy and safety of sitagliptin and saxagliptin with placebo and other hypoglycaemic medications in adults with type 2 diabetes. We searched MEDLINE®, Embase, the Cochrane Library and the International Pharmaceuticals from their inception through 3 February 2011. Studies were included of adults with type 2 diabetes that were 12 weeks or more in duration. Meta‐analyses were conducted when included studies were homogenous enough to justify combining their results. A total of 32 articles met inclusion criteria. Sitagliptin 100 mg monotherapy and saxagliptin 5 mg resulted in greater HbA1c reduction compared to placebo [weighted mean difference (WMD) −0.82%, 95% CI −0.95 to −0.70 and WMD −0.70, 95% CI −0.84 to −0.56, respectively]. Sitagliptin was similar to sulfonylureas for HbA1c reduction (WMD 0.08%, 95% CI 0–0.16, 3 trials) and to saxagliptin in one head‐to‐head trial. There was no statistically significant difference in hypoglycaemia between sitagliptin (pooled RR 1.55, 95% CI 0.55–4.36) or saxagliptin (pooled RR 1.04, 95% CI 0.28–3.81) and placebo. Sitagliptin and saxagliptin result in similar modest HbA1c reductions and do not increase the risk of hypoglycaemia unless combined with other therapies. Their role in the long‐term treatment of type 2 diabetes remains unclear given the lack of long‐term data on efficacy, harms and health outcomes.

Genetic polymorphisms and response to medications for alcohol use disorders: a systematic review and meta-analysis

AIM To assess whether response to medications for alcohol use disorders varies by genotype. METHODS Systematic review and meta-analysis. RESULTS We found no studies that assessed the clinical utility of genotype-guided dosing strategies or genotype-guided medication selection, and none randomized by genotype. All included studies assessed the association between genotype and response to medication. Of 15 included studies, eight (n = 1365 participants) assessed variation in naltrexone response and polymorphisms of OPRM1. Our meta-analyses for return to heavy drinking found no significant difference between A allele homozygotes and those with at least one G allele, both without (risk difference: 0.26; 95% CI: -0.01-0.53; n = 174) and with inclusion of studies rated as high or unclear risk of bias (risk difference: 0.14; 95% CI: -0.03-0.3; n = 382). For all other polymorphism-medication pairs, we found just one eligible study. CONCLUSION Estimates of effect for return to heavy drinking suggest it is possible that patients with at least one G allele of A118G polymorphism of OPRM1 might be more likely to respond to naltrexone, but confidence intervals were wide; additional studies are needed to improve confidence in the estimates.

Attention-deficit/hyperactivity disorder: identifying high priority future research needs.

With onset often occurring before 6 years of age, attention-deficit/hyperactivity disorder (ADHD) involves attention problems, impulsivity, overactivity, and sometimes disruptive behavior. Impairment usually persists into adulthood, with an estimated worldwide prevalence in adults of 2.5%. Existing gaps in evidence concerning ADHD hinder decision-making about treatment. This article describes and prioritizes future research needs for ADHD in three areas: treatment effectiveness for at-risk preschoolers; long-term treatment effectiveness; and variability in prevalence, diagnosis, and treatment. Using a recent systematic review concerning ADHD completed by a different evidence-based practice center as a foundation, we worked with a diverse group of 12 stakeholders, who represented researchers, funders, healthcare providers, patients, and families, to identify and prioritize research needs. From an initial list of 29 evidence gaps, we enumerated 8 high-priority research needs: a) accurate, brief standardized diagnosis and assessment; b) comparative effectiveness and safety of pharmacologic treatments for children under 6 years of age; c) comparative effectiveness of different combinations of psychosocial and pharmacologic treatments for children under 6 years of age; d) case identification and measurement of prevalence and outcomes; e) comparative effectiveness of psychosocial treatment alone versus pharmacologic and combination treatments for children under 6 years of age; f) comparative long-term treatment effectiveness for people 6 years of age and older; g) relative efficacy of specific psychosocial program components for children under 6 years of age; and h) identification of person-level effect modifiers for people 6 years of age and older. In this article, we describe these future research needs in detail and discuss study designs that could be used to address them. (Journal of Psychiatric Practice 2014;20:104–117)

Future research needs for evaluating the integration of mental health and substance abuse treatment with primary care

Research needs are many in the current health care environment. In this article, we describe a novel method developed by the Agency for Healthcare Research and Quality (AHRQ) Evidence-based Practice Center Program for pri- oritizing areas for future research. Using a recent- ly published systematic review as a foundation, investigators worked with a diverse group of 10 stakeholders to identify and prioritize research needs. We enumerate 13 high-priority research needs, as determined by stakeholders who repre- sented researchers, funders, health care providers, and patients and families, and discuss considerations for specific study designs. Our findings suggest that future research on inte- grating mental health and primary care should focus first on a) identifying methods of integrat- ing primary care into specialty mental health settings, b) identifying cross-cutting strategies for integration across multiple mental health diagnostic categories as opposed to a separate strategy for each diagnostic category, and c) examining the use of information technology for integrating mental and general medical health care. Other priorities for consideration include examining the economic and organizational sus- tainability of successful integration models, identifying dissemination methods for various settings, examining the business case for inte- gration as well as methods of payment, assessing the cost-effectiveness of integration, and identi- fying key components of successful strategies. The importance of sustainability and economic justification for integrated care strategies was a recurring theme in discussions with the stake- holders. The ability to sustain integrated care in everyday practice remains to be proved and will depend in part on the level of incentives and sup- port provided through payment system reform, as well as the ability of practices to provide care efficiently. (Journal of Psychiatric Practice 2013; 19:345–359)

Evaluating Evidence on Intermediate Outcomes: Considerations for Groups Making Healthcare Recommendations

INTRODUCTION Groups making recommendations need evidence about whether preventive services improve health outcomes (HOs). When such evidence is not available, groups may choose to evaluate evidence about effects on intermediate outcomes (IOs) and the link between IOs and HOs. This paper aims to describe considerations for assessing the evidence linking changes in IOs to changes in HOs. METHODS Working definitions of IOs, HOs, and other outcomes were developed. All current U.S. Preventive Services Task Force (USPSTF) recommendations through April 2016 were examined to identify how evidence of the IO-HO link was gathered and the criteria that appeared to be used to determine the adequacy of the evidence. Methods of other expert and recommendation-making groups were also examined. RESULTS Forty-four USPSTF recommendations involved a relevant IO-HO link. The approaches used most commonly to gather evidence about the link were selected review (19 of 44, 43%) and systematic review (12 of 44, 27%). Some key considerations when assessing the adequacy of evidence about the IO-HO link include adjustment for confounding, proximity of the IO to the HO in the causal pathway, and independence of IO-HO relationship from specific treatments. CONCLUSIONS Considerations were identified for recommendation-making groups to use when gathering and assessing the adequacy of evidence about the IO-HO link. Using a standard set of written principles could improve the transparency of assessments of the IO-HO link, especially if used together with judgment in a reasoned conjecture and refutation process. Ideally, the process would result in an estimate of the magnitude of change in HOs that is expected for specified changes in IOs.

Use of antipsychotic medications in pediatric and young adult populations: future research needs.

The use of antipsychotics, particularly second generation antipsychotics, among children and adolescents has increased markedly during the past 20 years. Existing evidence gaps make this practice controversial and hinder treatment decision-making. This article describes and prioritizes future research needs regarding antipsychotic treatment in youth, focusing on within-class and between-class drug comparisons with regard to key population subgroups, efficacy and effectiveness outcomes, and adverse event outcomes. Using as a foundation a recent systematic review of antipsychotic treatment among youth, which was completed by a different Evidence-based Practice Center, we worked with a diverse group of 12 stakeholders representing researchers, funders, health care providers, patients, and families to identify and prioritize research needs. From an initial list of 16 evidence gaps, we enumerated 6 high-priority research needs: 1) long-term comparative effectiveness across all psychiatric disorders; 2) comparative long-term risks of adverse outcomes; 3) short-term risks of adverse events; 4) differentials of efficacy, effectiveness, and safety for population subgroups; 5) comparative effectiveness among those with attention-deficit/hyperactivity disorder and disruptive behavior disorders and common comorbidities; 6) comparative effectiveness among those with bipolar disorder and common comorbidities. In this article, we describe these future research needs in detail and discuss study designs that could be used to address them. (Journal of Psychiatric Practice 2015;21:26–36)

A Framework to Guide Implementation Research for Care Transitions Interventions

AbstractEvaluating implementation of complex interventions to improve care transitions and comparison across studies is challenging due to issues such as variation in methods and lack of reporting key evaluation elements. This article describes a framework for evaluating implementation of hospital to ambulatory care transitions interventions and application to a case study. We searched published and gray literature for relevant frameworks. We adapted the general Consolidated Framework for Implementation Research, adding elements relevant to other complex interventions. We refined these adaptations through structured expert input and application to case studies. Key adaptations included conceptualization around organizations, not just settings, and around patient- and caregiver-centeredness. Although these interventions are often oriented toward institutional outcomes such as readmissions, tailoring interventions to specific patient needs strengthens effectiveness. Coordination and communication are important between organizations and providers and with patients and caregivers. Roles of those involved in the intervention—providers, administrators, and facilitators from different organizations—are also key constructs. Finally, as these interventions often are tailored to specific settings and adapt over time, assessing intervention design—which components are implemented as part of the bundle, how they are actually implemented, and their differential impact on effectiveness—is critical.