Benefits and harms of treatments for chronic nonspecific low back pain without radiculopathy: systematic review and meta-analysis.

BACKGROUND CONTEXT: Currently, there are no published studies that compare nonpharmacological, pharmacological and invasive treatments for chronic low back pain in adults and provide summary statistics for benefits and harms. PURPOSE: The aim of this review was to compare the benefits and harms of treatments for the management of chronic low back pain without radiculopathy and to report the findings in a format that facilitates direct comparison (Benefit-Harm Scale: level 1 to 7). DESIGN: Systematic review and meta-analysis of randomized controlled trials, including trial registries, from electronic databases up to 23rd May 2022. PATIENT SAMPLE: Adults with chronic nonspecific low back pain, excluding radicular pain, in any clinical setting. OUTCOME MEASURES: Comparison of pain at immediate-term (≤2 weeks) and short-term (>2 weeks to ≤12 weeks) and serious adverse events using the Benefit-Harm Scale (level 1 to 7). METHODS: This was a registered systematic review and meta-analysis of randomized controlled trials. Interventions included nonpharmacological (acupuncture, spinal manipulation), pharmacological and invasive treatments compared to placebo. Best evidence criteria was used. Two independent reviewers conducted eligibility assessment, data extraction and quality appraisal. RESULTS: The search retrieved 17,362 records. Three studies provided data on the benefits of interventions, and 30 provided data on harms. Studies included interventions of acupuncture (n=8); manipulation (n=2); pharmacological therapies (n=9), including NSAIDs and opioid analgesics; surgery (n=8); and epidural corticosteroid injections (n=3). Acupuncture (standardized mean difference (SMD) -0.51, 95%CI -0.88 to -0.14, n=1 trial, moderate quality of evidence, benefit rating of 3) and manipulation (SMD -0.39, 95%CI -0.56 to -0.21, n=2 trials, moderate quality of evidence, benefit rating of 5) were effective in reducing pain intensity compared to sham. The benefit of the other interventions was scored as uncertain due to not being effective, statistical heterogeneity preventing pooling of effect sizes, or the absence of relevant trials. The harms level warnings were at the lowest (eg, indicating rarer risk of events) for acupuncture, spinal manipulation, NSAIDs, combination ingredient opioids, and steroid injections, while they were higher for single ingredient opioid analgesics (level 4) and surgery (level 6). CONCLUSIONS: There is uncertainty about the benefits and harms of all the interventions reviewed due to the lack of trials conducted in patients with chronic nonspecific low back pain without radiculopathy. From the limited trials conducted, nonpharmacological interventions of acupuncture and spinal manipulation provide safer benefits than pharmacological or invasive interventions. However, more research is needed. There were high harms ratings for opioids and surgery.

Further Experience with the Practice Integration Profile: A Measure of Behavioral Health and Primary Care Integration.

Valid measures of behavioral health integration have the potential to enable comparisons of various models of integration, contribute to the overall development of high-quality care, and evaluate outcomes that are strategically aligned with standard improvement efforts. The Practice Integration Profile has proven to discriminate among clinic types and integration efforts. We continued the validation of the measure's internal consistency, intra-rater consistency, and inter-rater consistency with a separate and larger sample from a broader array of practices. We found that the Practice Integration Profile demonstrated a high level of internal consistency, suggesting empirically sound measurement of independent attributes of integration, and high reliability over time. The Practice Integration Profile provides internally consistent and interpretable results and can serve as both a quality improvement and health services research tool.

Understanding and applying the RE-AIM framework: Clarifications and resources.

INTRODUCTION: Understanding, categorizing, and using implementation science theories, models, and frameworks is a complex undertaking. The issues involved are even more challenging given the large number of frameworks and that some of them evolve significantly over time. As a consequence, researchers and practitioners may be unintentionally mischaracterizing frameworks or basing actions and conclusions on outdated versions of a framework. METHODS: This paper addresses how the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework has been described, summarizes how the model has evolved over time, and identifies and corrects several misconceptions. RESULTS: We address 13 specific areas where misconceptions have been noted concerning the use of RE-AIM and summarize current guidance on these issues. We also discuss key changes to RE-AIM over the past 20 years, including the evolution to Pragmatic Robust Implementation and Sustainability Model, and provide resources for potential users to guide application of the framework. CONCLUSIONS: RE-AIM and many other theories and frameworks have evolved, been misunderstood, and sometimes been misapplied. To some degree, this is inevitable, but we conclude by suggesting some actions that reviewers, framework developers, and those selecting or applying frameworks can do to prevent or alleviate these problems.

Measuring the integration of primary care and behavioral health services.

OBJECTIVE: To perform a factor analysis of the Practice Integration Profile (PIP), a 30-item practice-level measure of primary care and behavioral health integration derived from the Agency for Healthcare Research and Quality's Lexicon for Behavioral Health and Primary Care Integration. DATA SOURCES: The PIP was completed by 735 individuals, representing 357 practices across the United States. STUDY DESIGN: The study design was a cross-sectional survey. An exploratory factor analysis and assessment of internal consistency reliability via Cronbach's alpha were performed. DATA COLLECTION METHODS: Participant responses were collected using REDCap, a secure, web-based data capture tool. PRINCIPAL FINDINGS: Five of the PIP's six domains had factor loadings for most items related to each factor representing the PIP of 0.50 or greater. However, one factor had items from two PIP domains that had loadings >0.50. A five-factor model with redistributed items resulted in improved factor loadings for all domains along with greater internal consistency reliability (>0.80). CONCLUSIONS: Five of the PIP's six domains demonstrated excellent internal consistency for measures of health care resources. Although minor improvements to strengthen the PIP are possible, it is a valid and reliable measure of the integration of primary care and behavioral health.

Development and use of a clinical decision support tool for behavioral health screening in primary care clinics.

OBJECTIVE: Screening, brief intervention, and referral for treatment (SBIRT) for behavioral health (BH) is a key clinical process. SBIRT tools in electronic health records (EHR) are infrequent and rarely studied. Our goals were 1) to design and implement SBIRT using clinical decision support (CDS) in a commercial EHR; and 2) to conduct a pragmatic evaluation of the impact of the tools on clinical outcomes. METHODS: A multidisciplinary team designed SBIRT workflows and CDS tools. We analyzed the outcomes using a retrospective descriptive convenience cohort with age-matched comparison group. Data extracted from the EHR were evaluated using descriptive statistics. RESULTS: There were 2 outcomes studied: 1) development and use of new BH screening tools and workflows; and 2) the results of use of those tools by a convenience sample of 866 encounters. The EHR tools developed included a flowsheet for documenting screens for 3 domains (depression, alcohol use, and prescription misuse); and 5 alerts with clinical recommendations based on screening; and reminders for annual screening. Positive screen rate was 21% (≥1 domain) with 60% of those positive for depression. Screening was rarely positive in 2 domains (11%), and never positive in 3 domains. Positive and negative screens led to higher rates of documentation of brief intervention (BI) compared with a matched sample who did not receive screening, including changes in psychotropic medications, updated BH terms on the problem list, or referral for BH intervention. Clinical process outcomes changed even when screening was negative. CONCLUSIONS: Modified workflows for BH screening and CDS tools with clinical recommendations can be deployed in the EHR. Using SBIRT tools changed clinical process metrics even when screening was negative, perhaps due to conversations about BH not captured in the screening flowsheet. Although there are limitations to the study, results support ongoing investigation.

Development and validation of a measure of primary care behavioral health integration.

INTRODUCTION: We developed the Practice Integration Profile (PIP) to measure the degree of behavioral health integration in clinical practices with a focus on primary care (PC). Its 30 items, completed by providers, managers, and staff, provide an overall score and 6 domain scores derived from the Lexicon of Collaborative Care. We describe its history and psychometric properties. METHOD: The PIP was tested in a convenience sample of practices. Linear regression compared scores across integration exemplars, PC with behavioral services, PC without behavioral services, and community mental health centers without PC. An additional sample rated 4 scenarios describing practices with varying degrees of integration. RESULTS: One hundred sixty-nine surveys were returned. Mean domain scores ran from 49 to 65. The mean total score was 55 (median 58; range 0-100) with high internal consistency (Cronbach's alpha = .95). The lowest total scores were for PC without behavioral health (27), followed by community mental health centers (44), PC with behavioral health (60), and the exemplars (86; p < .001). Eleven respondents rerated their practices 37 to 194 days later. The mean change was + 1.5 (standard deviation = 11.1). Scenario scores were highly correlated with the degree of integration each scenario was designed to represent (Spearman's ρ = -0.71; P = 0.0005). DISCUSSION: These data suggest that the PIP is useful, has face, content, and internal validity, and distinguishes among types of practices with known variations in integration. We discuss how the PIP may support practices and policymakers in their integration efforts and researchers assessing the degree to which integration affects patient health outcomes. (PsycINFO Database Record

Health IT-Enabled Care Coordination: A National Survey of Patient-Centered Medical Home Clinicians.

PURPOSE: Health information technology (IT) offers promising tools for improving care coordination. We assessed the feasibility and acceptability of 6 proposed care coordination objectives for stage 3 of the Centers for Medicare and Medicaid Services electronic health record incentive program (Meaningful Use) related to referrals, notification of care from other facilities, patient clinical summaries, and patient dashboards. METHODS: We surveyed physician-owned and hospital/health system-affiliated primary care practices that achieved patient-centered medical home recognition and participated in the Meaningful Use program, and community health clinics with patient-centered medical home recognition (most with certified electronic health record systems). The response rate was 35.1%. We ascertained whether practices had implemented proposed objectives and perceptions of their importance. We analyzed the association of organizational and contextual factors with self-reported use of health IT to support care coordination activities. RESULTS: Although 78% of the 350 respondents viewed timely notification of hospital discharges as very important, only 48.7% used health IT systems to accomplish this task. The activity most frequently supported by health IT was providing clinical summaries to patients, in 76.6% of practices; however, merely 47.7% considered this activity very important. Greater use of health IT to support care coordination activities was positively associated with the presence of a nonclinician responsible for care coordination and the practice's capacity for systematic change. CONCLUSIONS: Even among practices having a strong commitment to the medical home model, the use of health IT to support care coordination objectives is not consistent. Health IT capabilities are not currently aligned with clinicians' priorities. Many practices will need financial and technical assistance for health IT to enhance care coordination.

The 5 R's: an emerging bold standard for conducting relevant research in a changing world.

Research often fails to find its way into practice or policy in a timely way, if at all. Given the current pressure and pace of health care change, many authors have recommended different approaches to make health care research more relevant and rapid. An emerging standard for research, the "5 R's" is a synthesis of recommendations for care delivery research that (1) is relevant to stakeholders; (2) is rapid and recursive in application; (3) redefines rigor; (4) reports on resources required; and (5) is replicable. Relevance flows from substantive ongoing participation by stakeholders. Rapidity and recursiveness occur through accelerated design and peer reviews followed by short learning/implementation cycles through which questions and answers evolve over time. Rigor is the disciplined conduct of shared learning within the specific changing situations in diverse settings. Resource reporting includes costs of interventions. Replicability involves designing for the factors that may affect subsequent implementation of an intervention or program in different contexts. These R's of the research process are mutually reinforcing and can be supported by training that fosters collaborative and reciprocal relationships among researchers, implementers, and other stakeholders. In sum, a standard is emerging for research that is both rigorous and relevant. Consistent and bold application will increase the value, timeliness, and applicability of the research enterprise.

Conducting rapid, relevant research: lessons learned from the My Own Health Report project.

The lengthy and uncertain translation of research into clinical practice is well documented. Much of the current "gold standard" clinical research is slow, expensive, and lacks perceived relevance for practitioners and decision makers. In contrast, we summarize experiences conducting the My Own Health Report (MOHR) project to collect and address patient reported measures using principles of rapid, relevant pragmatic research. The methods used for rapid design and fielding of the MOHR project to improve attention to health behaviors and mental health are detailed. Within the multisite, pragmatic, implementation-focused MOHR study, we describe the four phases of the research and the key decisions made and actions taken within each. We provide concrete examples of how relevant research can be conducted transparently to rapidly provide information to practitioners. Data were collected and analyzed in 2013. The multisite (seven research centers partnered with 18 clinics) cluster randomized pragmatic delayed intervention trial was conducted in less than 18 months from receipt of funding applications to completion of data collection. Phases that were especially accelerated included funding and review, and recruitment and implementation. Conducting complex studies rapidly and efficiently is a realistic goal. Key lessons learned for prevention research include use of existing research networks; use of web-based assessment/feedback tools that are tailored to fit local needs; engaging relevant stakeholders early on and throughout the process to minimize need for redesign; and making pragmatic decisions that balance internal and external validity concerns rather than waiting for perfect solutions.

Competencies for psychology practice in primary care.

This article reports on the outcome of a presidential initiative of 2012 American Psychological Association President Suzanne Bennett Johnson to delineate competencies for primary care (PC) psychology in six broad domains: science, systems, professionalism, relationships, application, and education. Essential knowledge, skills, and attitudes are described for each PC psychology competency. Two behavioral examples are provided to illustrate each competency. Clinical vignettes demonstrate the competencies in action. Delineation of these competencies is intended to inform education, practice, and research in PC psychology and efforts to further develop team-based competencies in PC.

Thinking about health-related outcomes: what do we need evidence about?

BACKGROUND: There is an urgent need for efficient, equitable interventions across the disease spectrum from prevention to palliative care. To identify and prioritize such interventions, evidence of effectiveness important to potential constituents is needed on outcomes relevant to them. METHODS: To inform practice and policy, evidence is needed on actionable, harmonized outcomes which are feasible to collect in most settings and relevant to citizens, practitioners, and decision makers. We propose that increased priority should be given to certain outcomes that are infrequently collected across multiple domains. RESULTS: A modification of a logic model of health outcomes by Proctor et al. is used to propose key domains and measures of implementation, service delivery, biomarkers, and health and functioning outcomes. Recommendations are made to give increased priority to implementation (especially reach, resource requirements/costs; and fidelity/adaptation); Institute of Medicine service delivery categories of equity and safety; and patient reported health and functioning outcomes. CONCLUSIONS: Implications of this outcomes framework include that biomarkers are not always the most important or relevant outcomes; that harmonized, pragmatic, and actionable measures are needed for each of these types of outcomes, and that significant changes in training and review of grants and publications are needed.

What does it mean to "employ" the RE-AIM model?

Many grant proposals identify the use of a given evaluation model or framework but offer little about how such models are implemented. The authors discuss what it means to employ a specific model, RE-AIM, and key dimensions from this model for program planning, implementation, evaluation, and reporting. The authors report both conceptual and content specifications for the use of the RE-AIM model and a content review of 42 recent dissemination and implementation grant applications to National Institutes of Health that proposed the use of this model. Outcomes include the extent to which proposals addressed the overall RE-AIM model and specific items within the five dimensions in their methods or evaluation plans. The majority of grants used only some elements of the model (less than 10% contained thorough measures across all RE-AIM dimensions). Few met criteria for "fully developed use" of RE-AIM and the percentage of key issues addressed varied from, on average, 45% to 78% across the RE-AIM dimensions. The results and discussion of key criteria should help investigators in their use of RE-AIM and illuminate the broader issue of comprehensive use of evaluation models.

Establishing the Collaborative Care Research Network (CCRN): a description of initial participating sites.

Collaborative care has increased dramatically in the past decade, yet the variability in collaborative strategies and the diversity of settings in which collaboration is being implemented make it difficult to assess quality and outcomes. Therefore, three aims were addressed in the current study: (a) describe and characterize the sites in the Collaborative Care Research Network (CCRN), (b) identify factors associated with practices' self-identified collaborative care model (e.g., coordinated, integrated, care management), and (c) identify limitations of available survey data elements so as to propose additional elements for future surveys. Initial (CCRN) sites completed surveys regarding several organizational factors (e.g., setting type, size of patient population, number of behavioral health providers). Results from 39 sites showed significant heterogeneity in self-identified type of collaborative care model practiced (e.g., integrated care, coordinated care), type of practice setting (e.g., academic, federally qualified health center, military), size of clinic, and ratio of behavioral health providers to medical providers. This diversity in network site characteristics can provide a rich platform to address a number of questions regarding the current practice of collaborative care. Recommendations are made to improve future surveys to better understand elements of the patient-centered medical home and the role it may play in outcomes. (PsycINFO Database Record (c) 2012 APA, all rights reserved).

Conversational assessment of hypnotic ability to promote hypnotic responsiveness.

In this article, hypnotic responsiveness is conceptualized as the byproduct of hypnotic ability, which is largely unalterable, plus hypnotic participation, which is highly subject to manipulation in the therapeutic context. This framework constitutes the basis of a model for the conversational assessment of hypnotic ability and hypnotic participation, as well as the subsequent tailoring of therapeutic interventions based on that assessment. Specific clinical steps for implementing activities implied by the model are explained and then demonstrated by way of a case example.