Lessons Learned from a National Initiative Promoting Publicly Available Standards-Based Clinical Decision Support.

BACKGROUND: Clinical decision support (CDS), which provides tools to assist clinical decision-making, can improve adherence to evidence-based practices, prevent medical errors, and support high-quality and patient-centered care delivery. Publicly available CDS that uses standards to express clinical logic (i.e., standards-based CDS) has the potential to reduce duplicative efforts of translating the same clinical evidence into CDS across multiple health care institutions. Yet development of such CDS is relatively new and its potential only partially explored. OBJECTIVES: This study aimed to describe lessons learned from a national initiative promoting publicly available, standards-based CDS resources, discuss challenges, and report suggestions for improvement. METHODS: Findings were drawn from an evaluation of the Agency for Healthcare Research and Quality Patient-Centered Outcomes Research CDS Initiative, which aimed to advance evidence into practice through standards-based and publicly available CDS. Methods included literature and program material reviews, key informant interviews, and a web-based survey about a public repository of CDS artifacts and tools for authoring standards-based CDS. RESULTS: The evaluation identified important lessons for developing and implementing standards-based CDS through publicly available repositories such as CDS Connect. Trust is a critical factor in uptake and can be bolstered through transparent information on underlying evidence, collaboration with experts, and feedback loops between users and developers to support continuous improvement. Additionally, while adoption of standards among electronic health record developers will make it easier to implement standards-based CDS, lower-resourced health systems will need extra support to ensure successful implementation and use. Finally, although we found the resources developed by the Initiative to offer valuable prototypes for the field, health systems desire more information about patient-centered, clinical, and cost-related outcomes to help them justify the investment required to implement standards-based, publicly available CDS. CONCLUSION: While the standards and technology to publicly share standards-based CDS have increased, broad dissemination and implementation remain challenging.

Challenges and opportunities for advancing patient-centered clinical decision support: findings from a horizon scan.

OBJECTIVE: We conducted a horizon scan to (1) identify challenges in patient-centered clinical decision support (PC CDS) and (2) identify future directions for PC CDS. MATERIALS AND METHODS: We engaged a technical expert panel, conducted a scoping literature review, and interviewed key informants. We qualitatively analyzed literature and interview transcripts, mapping findings to the 4 phases for translating evidence into PC CDS interventions (Prioritizing, Authoring, Implementing, and Measuring) and to external factors. RESULTS: We identified 12 challenges for PC CDS development. Lack of patient input was identified as a critical challenge. The key informants noted that patient input is critical to prioritizing topics for PC CDS and to ensuring that CDS aligns with patients' routine behaviors. Lack of patient-centered terminology standards was viewed as a challenge in authoring PC CDS. We found a dearth of CDS studies that measured clinical outcomes, creating significant gaps in our understanding of PC CDS' impact. Across all phases of CDS development, there is a lack of patient and provider trust and limited attention to patients' and providers' concerns. DISCUSSION: These challenges suggest opportunities for advancing PC CDS. There are opportunities to develop industry-wide practices and standards to increase transparency, standardize terminologies, and incorporate patient input. There is also opportunity to engage patients throughout the PC CDS research process to ensure that outcome measures are relevant to their needs. CONCLUSION: Addressing these challenges and embracing these opportunities will help realize the promise of PC CDS-placing patients at the center of the healthcare system.

The technical landscape for patient-centered CDS: progress, gaps, and challenges.

Supporting healthcare decision-making that is patient-centered and evidence-based requires investments in the development of tools and techniques for dissemination of patient-centered outcomes research findings via methods such as clinical decision support (CDS). This article explores the technical landscape for patient-centered CDS (PC CDS) and the gaps in making PC CDS more shareable, standards-based, and publicly available, with the goal of improving patient care and clinical outcomes. This landscape assessment used: (1) a technical expert panel; (2) a literature review; and (3) interviews with 18 CDS stakeholders. We identified 7 salient technical considerations that span 5 phases of PC CDS development. While progress has been made in the technical landscape, the field must advance standards for translating clinical guidelines into PC CDS, the standardization of CDS insertion points into the clinical workflow, and processes to capture, standardize, and integrate patient-generated health data.

Benefits and Harms of Prescription Drugs and Supplements for Treatment of Clinical Alzheimer-Type Dementia.

BACKGROUND: Effects of drug treatment of clinical Alzheimer-type dementia (CATD) are uncertain. PURPOSE: To summarize evidence on the effects of prescription drugs and supplements for CATD treatment. DATA SOURCES: Electronic bibliographic databases (inception to November 2019), ClinicalTrials.gov (to November 2019), and systematic review bibliographies. STUDY SELECTION: English-language trials of prescription drug and supplement treatment in older adults with CATD that report cognition, function, global measures, behavioral and psychological symptoms of dementia (BPSD), or harms. Minimum treatment was 24 weeks (≥2 weeks for selected BPSD). DATA EXTRACTION: Studies with low or medium risk of bias (ROB) were analyzed. Two reviewers rated ROB. One reviewer extracted data; another verified extraction accuracy. DATA SYNTHESIS: Fifty-five studies reporting non-BPSD outcomes (most ≤26 weeks) and 12 reporting BPSD (most ≤12 weeks) were analyzed. Across CATD severity, mostly low-strength evidence suggested that, compared with placebo, cholinesterase inhibitors produced small average improvements in cognition (median standardized mean difference [SMD], 0.30 [range, 0.24 to 0.52]), no difference to small improvement in function (median SMD, 0.19 [range, -0.10 to 0.22]), no difference in the likelihood of at least moderate improvement in global clinical impression (median absolute risk difference, 4% [range, 2% to 4%]), and increased withdrawals due to adverse events. In adults with moderate to severe CATD receiving cholinesterase inhibitors, low- to insufficient-strength evidence suggested that, compared with placebo, add-on memantine inconsistently improved cognition and improved global clinical impression but not function. Evidence was mostly insufficient about prescription drugs for BPSD and about supplements for all outcomes. LIMITATION: Most drugs had few trials without high ROB, especially for supplements, active drug comparisons, BPSD, and longer trials. CONCLUSION: Cholinesterase inhibitors and memantine slightly reduced short-term cognitive decline, and cholinesterase inhibitors slightly reduced reported functional decline, but differences versus placebo were of uncertain clinical importance. Evidence was mostly insufficient on drug treatment of BPSD and on supplements for all outcomes. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality. (PROSPERO: CRD42018117897).

Clinical Outcomes of Novel Long-Tapered Sirolimus-Eluting Coronary Stent System in Real-World Patients With Long Diffused De Novo Coronary Lesions.

BACKGROUND: When coronary lesions involve segments > 48 mm, the only treatment possibility is stent overlapping which is associated with higher neointimal proliferation that lead to more restenosis. Furthermore, tapering of coronary arteries is a major challenge observed with long diffuse coronary lesions. This study attempted to assess the safety and performance of world's first commercialised long-tapered (60 mm) sirolimus-eluting coronary stent (SES) system for the treatment of long diffused de novo coronary lesions in real world scenario. METHODS: This was a retrospective, non-randomised, multicentre study which included 362 consecutive patients implanted with long-tapered BioMime™ Morph SES system for the treatment of long diffused de novo coronary lesions. Safety endpoint was major adverse cardiac events (MACE), which was defined as composite of cardiac death, myocardial infarction (MI) and ischemic-driven target lesion revascularization (ID-TLR), at 12-month follow-up. RESULTS: Out of 362 patients included, 170 (47.0%) were diabetic and 159 (43.9%) were hypertensive. The mean age of all patients was 61.09 ± 9.04 years. A total of 625 lesions were identified; out of which 402 lesions were intervened successfully using BioMime Morph. The cumulative incidence of MACE was 7 (2.0%) at 12-month follow-up which included four (1.1%) cardiac deaths, one (0.3%) case of MI and two (0.6%) ID-TLR. Acute stent thrombosis was reported in one (0.3%) patient. CONCLUSIONS: The present study confirms the safety and performance of BioMime Morph, and hence, can be considered as a treatment of choice for long diffused tapered de novo coronary lesions in routine clinical practice.

Stakeholder participation in comparative effectiveness research: defining a framework for effective engagement.

AIMS: Stakeholder engagement is fundamental to comparative effectiveness research (CER), but lacks consistent terminology. This paper aims to define stakeholder engagement and present a conceptual model for involving stakeholders in CER. MATERIALS #ENTITYSTARTX00026; METHODS: The definitions and model were developed from a literature search, expert input and experience with the Center for Comparative Effectiveness Research in Cancer Genomics, a proof-of-concept platform for stakeholder involvement in priority setting and CER study design. RESULTS: Definitions for stakeholder and stakeholder engagement reflect the target constituencies and their role in CER. The 'analytic-deliberative' conceptual model for stakeholder engagement illustrates the inputs, methods and outputs relevant to CER. The model differentiates methods at each stage of the project; depicts the relationship between components; and identifies outcome measures for evaluation of the process. CONCLUSION: While the definitions and model require testing before being broadly adopted, they are an important foundational step and will be useful for investigators, funders and stakeholder groups interested in contributing to CER.

Facilitating comparative effectiveness research in cancer genomics: evaluating stakeholder perceptions of the engagement process.

AIMS: The Center for Comparative Effectiveness Research in Cancer Genomics completed a 2-year stakeholder-guided process for the prioritization of genomic tests for comparative effectiveness research studies. We sought to evaluate the effectiveness of engagement procedures in achieving project goals and to identify opportunities for future improvements. MATERIALS & METHODS: The evaluation included an online questionnaire, one-on-one telephone interviews and facilitated discussion. Responses to the online questionnaire were tabulated for descriptive purposes, while transcripts from key informant interviews were analyzed using a directed content analysis approach. RESULTS: A total of 11 out of 13 stakeholders completed both the online questionnaire and interview process, while nine participated in the facilitated discussion. Eighty-nine percent of questionnaire items received overall ratings of agree or strongly agree; 11% of responses were rated as neutral with the exception of a single rating of disagreement with an item regarding the clarity of how stakeholder input was incorporated into project decisions. Recommendations for future improvement included developing standard recruitment practices, role descriptions and processes for improved communication with clinical and comparative effectiveness research investigators. CONCLUSIONS: Evaluation of the stakeholder engagement process provided constructive feedback for future improvements and should be routinely conducted to ensure maximal effectiveness of stakeholder involvement.