Analyzing quality of life among people with opioid use disorder from the National Institute on Drug Abuse Data Share initiative: implications for decision making.

PURPOSE: We aimed to estimate health state utility values (HSUVs) for the key health states found in opioid use disorder (OUD) cost-effectiveness models in the published literature. METHODS: Data obtained from six trials representing 1,777 individuals with OUD. We implemented mapping algorithms to harmonize data from different measures of quality of life (the SF-12 Versions 1 and 2 and the EQ-5D-3 L). We performed a regression analysis to quantify the relationship between HSUVs and the following variables: days of extra-medical opioid use in the past 30 days, injecting behaviors, treatment with medications for OUD, HIV status, and age. A secondary analysis explored the impact of opioid withdrawal symptoms. RESULTS: There were statistically significant reductions in HSUVs associated with extra-medical opioid use (-0.002 (95% CI [-0.003,-0.0001]) to -0.003 (95% CI [-0.005,-0.002]) per additional day of heroin or other opiate use, respectively), drug injecting compared to not injecting (-0.043 (95% CI [-0.079,-0.006])), HIV-positive diagnosis compared to no diagnosis (-0.074 (95% CI [-0.143,-0.005])), and age (-0.001 per year (95% CI [-0.003,-0.0002])). Parameters associated with medications for OUD treatment were not statistically significant after controlling for extra-medical opioid use (0.0131 (95% CI [-0.0479,0.0769])), in line with prior studies. The secondary analysis revealed that withdrawal symptoms are a fundamental driver of HSUVs, with predictions of 0.817 (95% CI [0.768, 0.858]), 0.705 (95% CI [0.607, 0.786]), and 0.367 (95% CI [0.180, 0.575]) for moderate, severe, and worst level of symptoms, respectively. CONCLUSION: We observed HSUVs for OUD that were higher than those from previous studies that had been conducted without input from people living with the condition.

Thus far, health-related quality of life estimates for patients with opioid use disorder in the United States are limited, and importantly, they were not generated from studies among people living with the condition. This study extracted data from six clinical trials providing data among 1,777 people with opioid use disorder, made publicly available by the National Institutes of Health, to produce estimates of health-related quality of life. Our study found higher health-related quality of life estimates as compared to previous studies, modest impact of medications for opioid use disorder and strong impact of withdrawal symptoms on this outcome. These higher values among people with opioid use disorder might reflect the very negative perception of this condition among members of the general population (among whom these estimates have been generated previously). However, these relatively high estimates could also reflect an adaptation to the condition or a lack of awareness of associated-health damage in the context of dependence. The low number of observations providing data on medications for opioid use disorder led to high uncertainty around related estimates of health-related quality of life, but our findings could also reflect real experiences by patients in the absence of the positive effects of non-medication opioids, which deserve more attention in clinical practice. Our study suggests that systematically measuring withdrawal symptoms and representing these in health economic models might provide a more accurate representation of health-related quality of life among people with opioid use disorder and therefore of the impact and cost-effectiveness of interventions.

Strategies, processes, outcomes, and costs of implementing experience sampling-based monitoring in routine mental health care in four European countries: study protocol for the IMMERSE effectiveness-implementation study.

BACKGROUND: Recent years have seen a growing interest in the use of digital tools for delivering person-centred mental health care. Experience Sampling Methodology (ESM), a structured diary technique for capturing moment-to-moment variation in experience and behaviour in service users' daily life, reflects a particularly promising avenue for implementing a person-centred approach. While there is evidence on the effectiveness of ESM-based monitoring, uptake in routine mental health care remains limited. The overarching aim of this hybrid effectiveness-implementation study is to investigate, in detail, reach, effectiveness, adoption, implementation, and maintenance as well as contextual factors, processes, and costs of implementing ESM-based monitoring, reporting, and feedback into routine mental health care in four European countries (i.e., Belgium, Germany, Scotland, Slovakia). METHODS: In this hybrid effectiveness-implementation study, a parallel-group, assessor-blind, multi-centre cluster randomized controlled trial (cRCT) will be conducted, combined with a process and economic evaluation. In the cRCT, 24 clinical units (as the cluster and unit of randomization) at eight sites in four European countries will be randomly allocated using an unbalanced 2:1 ratio to one of two conditions: (a) the experimental condition, in which participants receive a Digital Mobile Mental Health intervention (DMMH) and other implementation strategies in addition to treatment as usual (TAU) or (b) the control condition, in which service users are provided with TAU. Outcome data in service users and clinicians will be collected at four time points: at baseline (t0), 2-month post-baseline (t1), 6-month post-baseline (t2), and 12-month post-baseline (t3). The primary outcome will be patient-reported service engagement assessed with the service attachment questionnaire at 2-month post-baseline. The process and economic evaluation will provide in-depth insights into in-vivo context-mechanism-outcome configurations and economic costs of the DMMH and other implementation strategies in routine care, respectively. DISCUSSION: If this trial provides evidence on reach, effectiveness, adoption, implementation and maintenance of implementing ESM-based monitoring, reporting, and feedback, it will form the basis for establishing its public health impact and has significant potential to bridge the research-to-practice gap and contribute to swifter ecological translation of digital innovations to real-world delivery in routine mental health care. TRIAL REGISTRATION: ISRCTN15109760 (ISRCTN registry, date: 03/08/2022).

Randomised study of the effects of sense of entitlement and conflict of interest contrarianism on researcher decision-making to work with the alcohol industry.

BACKGROUND: It is well established that the tobacco industry used research funding as a deliberate tactic to subvert science. There has been little wider attention to how researchers think about accepting industry funding. We developed, then tested, hypotheses about two psychological constructs, namely, entitlement and conflict of interest contrarianism (CoI-C) among alcohol researchers who had previously received industry funding. METHODS: A mixed-methods pilot study involved construct and instrument development, followed by an online survey and nested 3-arm randomised trial. We randomly allocated alcohol industry funding recipients to one of three conditions. In two experimental conditions we asked participants questions to remind them (and thus increase the salience) of their sense of entitlement or CoI-C. We compared these groups with a control group who did not receive any reminder. The outcome was a composite measure of openness to working with the alcohol industry. RESULTS: 133 researchers were randomised of whom 79 completed the experiment. The posterior distribution over effect estimates revealed that there was a 94.8% probability that reminding researchers of their CoI-C led them to self-report being more receptive to industry funding, whereas the probability was 68.1% that reminding them of their sense of entitlement did so. Biomedical researchers reported being more open to working with industry than did psychosocial researchers. CONCLUSION: Holding contrarian views on conflict of interest could make researchers more open to working with industry. This study shows how it is possible to study researcher decision-making using quantitative experimental methods.

Negative effects during multicomponent group-based treatment: A multisite study.

Objective Negative effects (NEs) in group treatments remain an under-researched area. This study aimed to explore the prevalence of various types of NEs in a multicomponent group-based treatment and to determine their predictors. Method: A total of 330 patients participating in a multicomponent group-based treatment were recruited across seven clinical sites. At the end of treatment, the Negative Effects Questionnaire (NEQ) was used to measure NEs. Item-level descriptive analysis was conducted to explore the prevalence of various types of NEs, and structural equation modeling was used to determine predictors of these NEs. Results: The most frequently reported type of NEs was the worsening of symptoms, and the single most frequently reported item was the resurfacing of unpleasant memories. Predictors of NEs included the overall distress level, alexithymia, attachment avoidance, low working alliance, problem actuation, and worse outcomes; psychological mindedness was a protective factor. Conclusion: Patients who experience higher levels of distress at the beginning of treatment, who perceive the group working alliance as problematic, and who experience high in-session emotional arousal related to their problem seem to be especially prone to reporting NEs. Furthermore, the findings do not support the assumption that NEs are a prerequisite for therapeutic change.Trial registration: ISRCTN.org identifier: ISRCTN13532466.

Common measures or common metrics? A plea to harmonize measurement results.

OBJECTIVE: There is a great variety of measurement instruments to assess similar constructs in clinical research and practice. This complicates the interpretation of test results and hampers the implementation of measurement-based care. METHOD: For reporting and discussing test results with patients, we suggest converting test results into universally applicable common metrics. Two well-established metrics are reviewed: T scores and percentile ranks. Their calculation is explained, their merits and drawbacks are discussed, and recommendations for the most convenient reference group are provided. RESULTS: We propose to express test results as T scores with the general population as reference group. To elucidate test results to patients, T scores may be supplemented with percentile ranks, based on data from a clinical sample. The practical benefits are demonstrated using the published data of four frequently used instruments for measuring depression: the CES-D, PHQ-9, BDI-II and the PROMIS depression measure. DISCUSSION: Recent initiatives have proposed to mandate a limited set of outcome measures to harmonize clinical measurement. However, the selected instruments are not without flaws and, potentially, this directive may hamper future instrument development. We recommend using common metrics as an alternative approach to harmonize test results in clinical practice, as this will facilitate the integration of measures in day-to-day practice.

Mechanisms of change in multicomponent group-based treatment for patients suffering from medically unexplained physical symptoms.

Understanding psychological mechanisms of change is essential to advance treatments for patients suffering from medically unexplained physical symptoms (MUPS). This study aimed to test the role of selected change mechanisms (incl. interoceptive awareness, emotional regulation skills, symptom acceptance, relational needs satisfaction, clarification of meaning, working alliance, and group cohesion) in the modification of patients' somatic symptom intensity and well-being.N = 290 patients suffering from MUPS participated in a multi-component group-based treatment at seven clinical sites. Data were collected weekly. Multi-level modeling was used to test cross-lagged relationships between the hypothesized mechanisms and outcomes in terms of Granger causality (with lags of 1, 2, and 3 weeks).None of the mechanisms predicted a time-lagged change in outcomes in the expected direction. In fact, there was a consistent pattern of negative time-lagged relationships (i.e., an increase in a mechanism predicted worsening of the outcome). Findings consistent with the hypothesized role of the mechanisms were found only in concurrent relationships between mechanisms and outcomes.This study did not support time-lagged relationships under the condition of weekly measurement and many methodological factors remain to be considered (e.g., a finer time resolution).

Service- and practitioner-level variation in non-consensual dropout from child mental health services.

Non-attendance of mental health service appointments is an international problem. In the UK, for example, the estimated cost of non-attendance in child mental health services is over £45 million (US dollar 60.94 million) per annum. The objective of this study was to examine whether there were service- and practitioner-level variation in non-consensual dropout in child mental health services. This was an analysis of routinely collected data. Service-level variation (as services covered different geographic areas) and practitioner-level variation were examined in N = 3622 children (mean age 12.70 years; SD 3.62, 57% female, 50% white or white British) seen by 896 practitioners across 39 services. Overall, 35% of the variation in non-consensual dropout was explained at the service level and 15% at the practitioner level. Children were almost four times more likely to drop out depending on which service they attended (median odds ratio = 3.92) and were two-and-a-half times more likely to drop out depending on which practitioner they saw (median odds ratio = 2.53). These levels of variation were not explained by levels of deprivation in areas covered by services or by children's demographic and case characteristics. The findings of the present research may suggest that, beyond service-level variation, there is also practitioner-level variation in non-consensual dropout in child mental health services.

Benefits and challenges in practice-oriented psychotherapy research in Germany: the TK and the QS-PSY-BAY projects of quality assurance in outpatient psychotherapy.

OBJECTIVE: Two patient-focused long-term research projects performed in the German outpatient psychotherapy system are focused on in this article. The TK (Techniker Krankenkasse) project is the first study to evaluate a quality assurance and feedback system with regard to its practical feasibility in German routine care. The other study ("Quality Assurance in Outpatient Psychotherapy in Bavaria"; QS-PSY-BAY) was designed to test a new approach for quality assurance in outpatient psychotherapy using electronic documentation of patient characteristics and outcome parameters. In addition this project provides the opportunity to analyze data on health-related costs for the patients undergoing outpatient psychotherapy. METHOD: Both projects and their results indicating high effect sizes are briefly described. RESULTS: From the perspectives of the research teams, advisory boards and other stakeholders, the experiences with these projects are discussed focusing on obstacles, challenges, difficulties, and benefits in developing and implementing the studies. The triangle collaboration of therapists, researchers, and health insurance companies/health service institutions turned out to be fruitful in both studies. CONCLUSIONS: Despite some controversies between the partners the experiences indicate the importance of practiced-research collaborations to provide relevant information about the delivery of outpatient psychotherapy in the health system.

In Support of Multidimensional Frailty: A Structural Equation Model from the Canadian Positive Brain Health Now Cohort.

The objective of this study was to estimate the structure and relationships between four h ypothesized frailty dimensions (physical, emotional, cognitive, and social) and the extent to which personal and HIV-related factors and comorbidity associate with these frailty dimensions. This is a secondary analysis of an existing dataset arising from Positive Brain Health Now study (n = 856) in people aging with HIV (mean age: 52.3 ± 8.1 years). Structural equation modeling (SEM) models were applied to two cross-sections of the data: one at study entry and one at second visit, 9-month apart. Multidimensional frailty was modeled based on the combined Wilson-Cleary and International Classification of Functioning, Disability and Health framework. Four dimensions were operationalized with patient-reported and self-report measures from standardized questionnaires. The SEM model from the first visit was replicated using data from the second visit, testing measurement invariance. The proposed model showed acceptable fit at both visits (including no violation of measurement invariance). The final model for the first visit showed that sex, body mass index, HIV diagnosis pre-1997, current or nadir CD4 counts, and comorbidity did not associate with any frailty dimension; however, age (ß range: 0.12-0.25), symptoms (ß range: -0.35 to -0.58), and measured cognition (ß range: 0.10-0.24) directly associated with all frailty dimensions. The model remained stable across the two visits. This study contributes evidence for operationalizing multidimensional frailty. Evidence-based interventions are available for many of the measures considered here, offering opportunities to improve the lives of people with frailty in the context of HIV.

An interpretative phenomenological analysis of the lived experience of people with multimorbidity in low- and middle-income countries.

People living with multimorbidity (PLWMM) have multiple needs and require long-term personalised care, which necessitates an integrated people-centred approach to healthcare. However, people-centred care may risk being a buzzword in global health and cannot be achieved unless we consider and prioritise the lived experience of the people themselves. This study captures the lived experiences of PLWMM in low- and middle-income countries (LMICs) by exploring their perspectives, experiences, and aspirations.We analysed 50 semi-structured interview responses from 10 LMICs across three regions-South Asia, Latin America, and Western Africa-using an interpretative phenomenological analysis approach.The bodily, social, and system experiences of illness by respondents were multidirectional and interactive, and largely captured the complexity of living with multimorbidity. Despite expensive treatments, many experienced little improvements in their conditions and felt that healthcare was not tailored to their needs. Disease management involved multiple and fragmented healthcare providers with lack of guidance, resulting in repetitive procedures, loss of time, confusion, and frustration. Financial burden was exacerbated by lost productivity and extreme finance coping strategies, creating a vicious cycle. Against the backdrop of uncertainty and disruption due to illness, many demonstrated an ability to cope with their conditions and navigate the healthcare system. Respondents' priorities were reflective of their desire to return to a pre-illness way of life-resuming work, caring for family, and maintaining a sense of independence and normalcy despite illness. Respondents had a wide range of needs that required financial, health education, integrated care, and mental health support.In discussion with respondents on outcomes, it appeared that many have complementary views about what is important and relevant, which may differ from the outcomes established by clinicians and researchers. This knowledge needs to complement and be incorporated into existing research and treatment models to ensure healthcare remains focused on the human and our evolving needs.

The LEADING Guideline. Reporting Standards for Expert Panel, Best-Estimate Diagnosis, and Longitudinal Expert All Data (LEAD) Studies.

Background: Accurate assessments of symptoms and illnesses are essential for health research and clinical practice but face many challenges. The absence of a single error-free measure is currently addressed by assessment methods involving experts reviewing several sources of information to achieve a more accurate or best-estimate assessment. Three bodies of work spanning medicine, psychiatry, and psychology propose similar assessment methods: The Expert Panel, the Best-Estimate Diagnosis, and the Longitudinal Expert All Data (LEAD) method. However, the quality of such best-estimate assessments is typically very difficult to evaluate due to poor reporting of the assessment methods and when they are reported, the reporting quality varies substantially. Here, we tackle this gap by developing reporting guidelines for such best-estimate assessment studies. Methods: The development of the reporting guidelines followed a four-stage approach: 1) drafting reporting standards accompanied by rationales and empirical evidence, which were further developed with a patient organization for depression, 2) incorporating expert feedback through a two-round Delphi procedure, 3) refining the guideline based on an expert consensus meeting, and 4) testing the guideline by i) having two researchers test it and ii) using it to examine the extent previously published studies report the standards. The last step also provides evidence for the need for the guideline: 10 to 63% (Mean = 33%) of the standards were not reported across thirty randomly selected studies. Results: The LEADING guideline comprises 20 reporting standards related to four groups: The Longitudinal design (four standards); the Appropriate data (four standards); the Evaluation - experts, materials, and procedures (ten standards); and the Validity group (two standards). Conclusions: We hope that the LEADING guideline will be useful in assisting researchers in planning, conducting, reporting, and evaluating research aiming to achieve best-estimate assessments.

Transdiagnostic Ecological Momentary Intervention for Improving Self-Esteem in Youth Exposed to Childhood Adversity: The SELFIE Randomized Clinical Trial.

Importance: Targeting low self-esteem in youth exposed to childhood adversity is a promising strategy for preventing adult mental disorders. Ecological momentary interventions (EMIs) allow for the delivery of youth-friendly, adaptive interventions for improving self-esteem, but robust trial-based evidence is pending. Objective: To examine the efficacy of SELFIE, a novel transdiagnostic, blended EMI for improving self-esteem plus care as usual (CAU) compared with CAU only. Design, Setting, and Participants: This was a 2-arm, parallel-group, assessor-blinded, randomized clinical trial conducted from December 2018 to December 2022. The study took place at Dutch secondary mental health services and within the general population and included youth (aged 12-26 years) with low self-esteem (Rosenberg Self-Esteem Scale [RSES] <26) exposed to childhood adversity. Interventions: A novel blended EMI (3 face-to-face sessions, email contacts, app-based, adaptive EMI) plus CAU or CAU only. Main Outcomes and Measures: The primary outcome was RSES self-esteem at postintervention and 6-month follow-up. Secondary outcomes included positive and negative self-esteem, schematic self-beliefs, momentary self-esteem and affect, general psychopathology, quality of life, observer-rated symptoms, and functioning. Results: A total of 174 participants (mean [SD] age, 20.7 [3.1] years; 154 female [89%]) were included in the intention-to-treat sample, who were primarily exposed to childhood emotional abuse or neglect, verbal or indirect bullying, and/or parental conflict. At postintervention, 153 participants (87.9%) and, at follow-up, 140 participants (80.5%), provided primary outcome data. RSES self-esteem was, on average, higher in the experimental condition (blended EMI + CAU) than in the control condition (CAU) across both postintervention and follow-up as a primary outcome (B = 2.32; 95% CI, 1.14-3.50; P < .001; Cohen d-type effect size [hereafter, Cohen d] = 0.54). Small to moderate effect sizes were observed suggestive of beneficial effects on positive (B = 3.85; 95% CI, 1.83-5.88; P < .001; Cohen d = 0.53) and negative (B = -3.78; 95% CI, -6.59 to -0.98; P = .008; Cohen d = -0.38) self-esteem, positive (B = 1.58; 95% CI, 0.41-2.75; P = .008; Cohen d = 0.38) and negative (B = -1.71; 95% CI, -2.93 to -0.48; P = .006; Cohen d = -0.39) schematic self-beliefs, momentary self-esteem (B = 0.29; 95% CI, 0.01-0.57; P = .04; Cohen d = 0.24), momentary positive affect (B = 0.23; 95% CI, 0.01-0.45; P = .04; Cohen d = 0.20), momentary negative affect (B = -0.33; 95% CI, -0.59 to -0.03, P = .01, Cohen d = -0.27), general psychopathology (B = -17.62; 95% CI, -33.03 to -2.21; P = .03; Cohen d = -0.34), and quality of life (B = 1.16; 95% CI, 0.18-2.13; P = .02; Cohen d = 0.33) across postintervention and follow-up. No beneficial effects on symptoms and functioning were observed. Conclusions and Relevance: A transdiagnostic, blended EMI demonstrated efficacy on the primary outcome of self-esteem and signaled beneficial effects on several secondary outcomes. Further work should focus on implementing this novel EMI in routine public mental health provision. Trial Registration: Dutch Trial Register Identifier:NL7129(NTR7475).

Core outcome sets for trials of interventions to prevent and to treat multimorbidity in adults in low and middle-income countries: the COSMOS study.

INTRODUCTION: The burden of multimorbidity is recognised increasingly in low- and middle-income countries (LMICs), creating a strong emphasis on the need for effective evidence-based interventions. Core outcome sets (COS) appropriate for the study of multimorbidity in LMICs do not presently exist. These are required to standardise reporting and contribute to a consistent and cohesive evidence-base to inform policy and practice. We describe the development of two COS for intervention trials aimed at preventing and treating multimorbidity in adults in LMICs. METHODS: To generate a comprehensive list of relevant prevention and treatment outcomes, we conducted a systematic review and qualitative interviews with people with multimorbidity and their caregivers living in LMICs. We then used a modified two-round Delphi process to identify outcomes most important to four stakeholder groups (people with multimorbidity/caregivers, multimorbidity researchers, healthcare professionals and policymakers) with representation from 33 countries. Consensus meetings were used to reach agreement on the two final COS. REGISTRATION: https://www.comet-initiative.org/Studies/Details/1580. RESULTS: The systematic review and qualitative interviews identified 24 outcomes for prevention and 49 for treatment of multimorbidity. An additional 12 prevention and 6 treatment outcomes were added from Delphi round 1. Delphi round 2 surveys were completed by 95 of 132 round 1 participants (72.0%) for prevention and 95 of 133 (71.4%) participants for treatment outcomes. Consensus meetings agreed four outcomes for the prevention COS: (1) adverse events, (2) development of new comorbidity, (3) health risk behaviour and (4) quality of life; and four for the treatment COS: (1) adherence to treatment, (2) adverse events, (3) out-of-pocket expenditure and (4) quality of life. CONCLUSION: Following established guidelines, we developed two COS for trials of interventions for multimorbidity prevention and treatment, specific to adults in LMIC contexts. We recommend their inclusion in future trials to meaningfully advance the field of multimorbidity research in LMICs. PROSPERO REGISTRATION NUMBER: CRD42020197293.