Healthcare providers' understanding of data displays of clinical trial information: a scoping review of the literature.

BACKGROUND: Healthcare providers often encounter clinical trial results in the form of visual data displays. Although there is a robust literature on patient responses to data displays in medical settings, less is known about how providers comprehend and apply this information. Our study provides a scoping review of the literature on providers' reactions to and perceptions of data displays. METHODS: We searched article databases (PubMed, PsycINFO, Web of Science, Cumulative Index to Nursing and Allied Health Literature, the Cochrane Library) supplemented by handsearching. Eligible articles were published in English from 1990 to 2020. RESULTS: We identified 15 articles meeting our criteria. Studies with physicians were more prevalent (13/15) than those with other healthcare providers (6/15). Commonly assessed outcomes included objective (10/15) and subjective comprehension (4/15), preference for certain data display formats (6/15), and hypothetical decision-making around prescribing (4/15). In studies that assessed comprehension of clinical trial concepts, scores were average or below what would be considered mastery of the information. Data display formats that were preferred did not always correlate with better comprehension of information; lesser preferred formats (e.g. icon array) often resulted in better comprehension. CONCLUSION: Our findings suggest that healthcare providers may not accurately interpret complex types of data displays, and it is unknown if such limitations affect actual decision-making. Interventions are needed to enhance comprehension of complex data displays within the context of prescription drug professional promotion.

Minimally invasive sacroiliac joint fusion for chronic sacroiliac joint pain: a systematic review.

BACKGROUND CONTEXT: Sacroiliac (SI) joint pain causes significant disability and impairment to quality of life (QOL). Minimally invasive SI joint fusion is increasingly used to relieve chronic SI joint pain among patients who do not respond to nonsurgical treatment. PURPOSE: To systematically review the existing literature to assess the effectiveness and safety of minimally invasive SI joint fusion. STUDY DESIGN/SETTING: Systematic review. DATA SOURCES: PubMed, Embase, Cochrane, and a clinical trial registry from database inception to June 30, 2021. STUDY SELECTION: Eligible studies were primary research studies published in the English language, enrolled adults with SI joint pain, and compared SI joint fusion to nonsurgical interventions or alternative minimally invasive procedures. We included randomized controlled trials (RCTs) or controlled cohort studies (CCSs) that reported effectiveness (pain, physical function, QOL, opioid use) or safety outcomes (adverse events [AEs], revision surgeries) and uncontrolled studies that reported safety outcomes. DATA ABSTRACTION AND SYNTHESIS: Data were abstracted into structured forms; two independent reviewers assessed risk of bias using standard instruments; certainty of evidence was rated using GRADE. RESULTS: Forty studies (2 RCTs, 3 CCSs, and 35 uncontrolled studies) were included. Minimally invasive SI joint fusion with the iFuse Implant System appeared to result in larger improvements in pain (two RCTs: mean difference in visual analog scale -40.5 mm, 95% CI, -50.1 to -30.9; -38.1 mm, p<.0001) and larger improvements in physical function (mean difference in Oswestry Disability Index -25.4 points, 95% CI, -32.5 to -18.3; -19.8 points, p<.0001) compared to conservative management at 6 months. Improvements in pain and physical function for the RCTs appeared durable at 1- and 2-year follow-up. Findings were similar in one CCS. The two RCTs also found significant improvements in QOL at 6 months and 1 year. Opioid use may be improved at 6 months and 1 to 2 years. AEs appeared higher in the fusion group at 6 months. The incidence of revision surgery varied by study; the highest was 3.8% at 2 years. Two CCSs compared the effectiveness of alternative minimally invasive fusion procedures. One CCS compared iFuse to the Rialto SI Fusion System and reported no differences in pain, function, QOL, and revision surgeries from 6 months to 1 year. One CCS compared iFuse to percutaneous screw fixation and reported significantly fewer revisions among iFuse participants (mean difference -61.0%, 95% CI, -78.4% to -43.5%). The 35 uncontrolled studies had serious limitations and reported heterogeneous safety outcomes. Two of the larger studies reported a 13.2% incidence of complications from minimally invasive SI joint fusion at 90 days using an insurance claims database and a 3.1% incidence of revision surgery over 2.5 years using a postmarket surveillance database. CONCLUSIONS: Among patients meeting diagnostic criteria for SI joint pain and who have not responded to conservative care, minimally invasive SI joint fusion is probably more effective than conservative management for reducing pain and opioid use and improving physical function and QOL. Fusion with iFuse and Rialto appear to have similar effectiveness. AEs appear to be higher for minimally invasive SI joint fusion than conservative management through 6 months. Based on evidence from uncontrolled studies, serious AEs from minimally invasive SI joint fusion may be higher in usual practice compared to what is reported in trials. The incidence of revision surgery is likely no higher than 3.8% at 2 years. Limited evidence is available that compares different minimally invasive devices.

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.

A framework to guide implementation research for care transitions interventions.

Evaluating 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.

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 prioritizing 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 represented researchers, funders, health care providers, and patients and families, and discuss considerations for specific study designs. Our findings suggest that future research on integrating mental health and primary care should focus first on a) identifying methods of integrating 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 integration as well as methods of payment, assessing the cost-effectiveness of integration, and identifying 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.

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.

Closing the quality gap: revisiting the state of the science (vol. 4: medication adherence interventions: comparative effectiveness).

OBJECTIVES: To assess the effectiveness of patient, provider, and systems interventions (Key Question [KQ] 1) or policy interventions (KQ 2) in improving medication adherence for an array of chronic health conditions. For interventions that are effective in improving adherence, we then assessed their effectiveness in improving health, health care utilization, and adverse events. DATA SOURCES: MEDLINE®, the Cochrane Library. Additional studies were identified from reference lists and technical experts. REVIEW METHODS: Two people independently selected, extracted data from, and rated the risk of bias of relevant trials and systematic reviews. We synthesized the evidence for effectiveness separately for each clinical condition, and within each condition, by type of intervention. We also evaluated the prevalence of intervention components across clinical conditions and the effectiveness of interventions for a range of vulnerable populations. Two reviewers graded the strength of evidence using established criteria. RESULTS: We found a total of 62 eligible studies (58 trials and 4 observational studies) from our review of 3,979 abstracts. These studies included patients with diabetes, hyperlipidemia, hypertension, heart failure, myocardial infarction, asthma, depression, glaucoma, multiple sclerosis, musculoskeletal diseases, and multiple chronic conditions. Fifty-seven trials of patient, provider, or systems interventions (KQ 1) evaluated 20 different types of interventions; 4 observational studies and one trial of policy interventions (KQ 2) evaluated the effect of reduced out-of-pocket expenses or improved prescription drug coverage. We found the most consistent evidence of improvement in medication adherence for interventions to reduce out-of-pocket expenses or improve prescription drug coverage, case management, and educational interventions across clinical conditions. Within clinical conditions, we found the strongest support for self-management of medications for short-term improvement in adherence for asthma patients; collaborative care or case management programs for short-term improvement of adherence and to improve symptoms for patients taking depression medications; and pharmacist-led approaches for hypertensive patients to improve systolic blood pressure. CONCLUSIONS: Diverse interventions offer promising approaches to improving medication adherence for chronic conditions, particularly for the short term. Evidence on whether these approaches have broad applicability for clinical conditions and populations is limited, as is evidence regarding long-term medication adherence or health outcomes.

Family history of diabetes as a potential public health tool.

Given the substantial morbidity and mortality associated with type 2 diabetes, it is important that public health seek ways to delay or prevent the onset of this condition. Risk factors for type 2 diabetes are well established and include underlying genetic susceptibility. Despite this knowledge, as well as significant advances in understanding the human genome, the prevalence of type 2 diabetes continues to rise at an alarming rate. Because type 2 diabetes is a complex condition involving a combination of genetic and environmental factors, DNA testing for susceptibility genes is not yet warranted. However, because family history reflects genetic susceptibility in addition to other factors, it may be a useful public health tool for disease prevention. When evaluating family history as a public health tool, several important issues need to be considered, including the analytic and clinical validity and the clinical utility of using family history as a screening tool. These issues as well as a review of the epidemiologic evidence evaluating family history as a risk factor will be reviewed.Overall, a family history approach appears to be a promising new public health tool to fight the growing epidemic of diabetes in the United States. Adequate levels of funding to further evaluate this approach and to develop appropriate tools should be made available for research activities focused on this important area.