A core outcome set for trials evaluating self-management interventions in people with severe mental illness and coexisting type 2 diabetes.

BACKGROUND: People with severe mental illness (SMI), such as schizophrenia, have higher rates of type 2 diabetes and worse outcomes, compared to those without SMI and it is not known whether diabetes self-management interventions are effective for people who have both conditions. Research in this area has been impeded by a lack of consensus on which outcomes to prioritise in people with co-existing SMI and diabetes. AIMS: To develop a core outcome set (COS) for use in effectiveness trials of diabetes self-management interventions in adults with both type 2 diabetes and SMI. METHODS: The COS was developed in three stages: (i) identification of outcomes from systematic literature review of intervention studies, followed by multi-stakeholder and service user workshops; (ii) rating of outcomes in a two-round online Delphi survey; (iii) agreement of final 'core' outcomes through a stakeholder consensus workshop. RESULTS: Seven outcomes were selected: glucose control, blood pressure, body composition (body weight, BMI, body fat), health-related quality of life, diabetes self-management, diabetes-related distress and medication adherence. CONCLUSIONS: This COS is recommended for future trials of effectiveness of diabetes self-management interventions for people with SMI and type 2 diabetes. Its use will ensure trials capture important outcomes and reduce heterogeneity so findings can be readily synthesised to inform practice and policy.

Response shift results of quantitative research using patient-reported outcome measures: a descriptive systematic review.

PURPOSE: The objective of this systematic review was to describe the prevalence and magnitude of response shift effects, for different response shift methods, populations, study designs, and patient-reported outcome measures (PROM)s. METHODS: A literature search was performed in MEDLINE, PSYCINFO, CINAHL, EMBASE, Social Science Citation Index, and Dissertations & Theses Global to identify longitudinal quantitative studies that examined response shift using PROMs, published before 2021. The magnitude of each response shift effect (effect sizes, R-squared or percentage of respondents with response shift) was ascertained based on reported statistical information or as stated in the manuscript. Prevalence and magnitudes of response shift effects were summarized at two levels of analysis (study and effect levels), for recalibration and reprioritization/reconceptualization separately, and for different response shift methods, and population, study design, and PROM characteristics. Analyses were conducted twice: (a) including all studies and samples, and (b) including only unrelated studies and independent samples. RESULTS: Of the 150 included studies, 130 (86.7%) detected response shift effects. Of the 4868 effects investigated, 793 (16.3%) revealed response shift. Effect sizes could be determined for 105 (70.0%) of the studies for a total of 1130 effects, of which 537 (47.5%) resulted in detection of response shift. Whereas effect sizes varied widely, most median recalibration effect sizes (Cohen's d) were between 0.20 and 0.30 and median reprioritization/reconceptualization effect sizes rarely exceeded 0.15, across the characteristics. Similar results were obtained from unrelated studies. CONCLUSION: The results draw attention to the need to focus on understanding variability in response shift results: Who experience response shifts, to what extent, and under which circumstances?

A systematic review of quality of life and health-related quality of life as outcomes in substance and behavioural addictions.

ISSUES: Consideration of an individual's quality of life (QoL) can benefit assessment and treatment of addictive disorders, however, uncertainty remains over operationalisation of the construct as an outcome and the appropriateness of existing measures for these populations. This systematic review aimed to identify and evaluate QoL and health-related QoL outcome instruments used in addiction-related risk and harm research and map their conceptualised domains. APPROACH: Three electronic databases and a specialised assessment library were searched on 1 February 2022 for QoL or health-related QoL outcome instruments used with addiction-related risk and harm populations. PRISMA reporting guidance was followed and included outcome instruments were appraised using mixed methods. Psychometric evidence supporting their use was summarised. The COSMIN risk of bias tool was used to assess validation studies. KEY FINDINGS: A total of 298 articles (330 studies) used 53 outcome instruments and 41 unique domains of QoL. Eleven instruments' psychometric properties were evaluated. No instrument was assessed for any parameter in at least five studies for meta-analytic pooling. Cronbach's alpha (α) internal consistency was the most widely assessed parameter with the AQoLS, WHOQOL-BREF, ALQoL-9, Q-LES-Q-SF, SF-12, DUQoL, QLI and SF-36 displaying promising statistics (α > 0.70). IMPLICATIONS AND CONCLUSION: Many instruments have been utilised. However, a significant proportion of studies applied a small number of instruments with minimal high-quality validation evidence supporting their use within addiction-related risk and harm. Promising instruments are recommended, however, the paucity of supporting evidence limits confidence in the reliability and validity of QoL measurement in these populations.

Implications of the syntheses on definition, theory, and methods conducted by the Response Shift - in Sync Working Group.

PURPOSE: Our aim is to advance response shift research by explicating the implications of published syntheses by the Response Shift - in Sync Working Group in an integrative way and suggesting ways for improving the quality of future response shift studies. METHODS: Members of the Working Group further discussed the syntheses of the literature on definitions, theoretical underpinnings, operationalizations, and response shift methods. They outlined areas in need of further explication and refinement, and delineated additional implications for future research. RESULTS: First, the proposed response shift definition was further specified and its implications for the interpretation of results explicated in relation to former, published definitions. Second, the proposed theoretical model was further explained in relation to previous theoretical models and its implications for formulating research objectives highlighted. Third, ways to explore alternative explanations per response shift method and their implications for response shift detection and explanation were delineated. The implications of the diversity of the response shift methods for response shift research were presented. Fourth, the implications of the need to enhance the quality and reporting of the response shift studies for future research were sketched. CONCLUSION: With our work, we intend to contribute to a common language regarding response shift definitions, theory, and methods. By elucidating some of the major implications of earlier work, we hope to advance response shift research.

Response shift in patient-reported outcomes: definition, theory, and a revised model.

PURPOSE: The extant response shift definitions and theoretical response shift models, while helpful, also introduce predicaments and theoretical debates continue. To address these predicaments and stimulate empirical research, we propose a more specific formal definition of response shift and a revised theoretical model. METHODS: This work is an international collaborative effort and involved a critical assessment of the literature. RESULTS: Three main predicaments were identified. First, the formal definitions of response shift need further specification and clarification. Second, previous models were focused on explaining change in the construct intended to be measured rather than explaining the construct at multiple time points and neglected the importance of using at least two time points to investigate response shift. Third, extant models do not explicitly distinguish the measure from the construct. Here we define response shift as an effect occurring whenever observed change (e.g., change in patient-reported outcome measures (PROM) scores) is not fully explained by target change (i.e., change in the construct intended to be measured). The revised model distinguishes the measure (e.g., PROM) from the underlying target construct (e.g., quality of life) at two time points. The major plausible paths are delineated, and the underlying assumptions of this model are explicated. CONCLUSION: It is our hope that this refined definition and model are useful in the further development of response shift theory. The model with its explicit list of assumptions and hypothesized relationships lends itself for critical, empirical examination. Future studies are needed to empirically test the assumptions and hypothesized relationships.

Changes in Trauma-Related Emotions Following Treatment With Dialectical Behavior Therapy for Posttraumatic Stress Disorder After Childhood Abuse.

Dialectical behavior therapy for posttraumatic stress disorder (DBT-PTSD) is a trauma-focused therapy shown to reduce core PTSD symptoms, such as intrusions, hyperarousal, and avoidance. Preliminary data indicate effects on elevated trauma-related emotions (e.g., guilt and shame) and possibly radical acceptance of the traumatic event. However, it is unclear if improvements in these variables are significant after controlling for changes in core PTSD symptoms and to what extent nonclinical levels are obtained. In the current study, 42 individuals who met criteria for PTSD after childhood abuse and were participating in a 3-month residential DBT-PTSD program were evaluated at the start of the exposure phase of DBT-PTSD and the end of treatment; a nonclinical sample with a history of childhood abuse was the reference group. Multivariate analyses of variance and multivariate analyses of covariance controlling for change in core PTSD symptoms were used to evaluate changes in several elevated trauma-related emotions (fear, anger, guilt, shame, disgust, sadness, and helplessness) and in radical acceptance. In a repeated measures multivariate analyses of variance, both elevated trauma-related emotions and radical acceptance significantly improved during DBT-PTSD, λ = 0.34, p < .001; η2 = .56; t(40) = -5.66, p < .001, SMD = 0.88, even after controlling for changes in PTSD symptoms, λ = 0.35, p < .001, η2 = .65; Λ = 0.86, p = .018, η2 = .14, respectively. Posttreatment, 31.0% (for acceptance) to 76.2% (for guilt) of participants showed nonclinical levels of the investigated outcomes, suggesting that both trauma-related emotions and radical acceptance changed after the 3-month residential DBT-PTSD program.

Spanish Abstracts by Asociación Chilena de Estrés Traumático (ACET) Los Cambios en las Emociones Relacionadas al Trauma posterior al Tratamiento con Terapia Dialéctica Conductual para el Trastorno de Estrés Traumático después de Abuso Infantil EMOCION RELACIONADA AL TRAUMA Y TERAPIA DIALECTICA CONDUCTUAL La terapia dialéctica conductual para el trastorno de estrés traumático (TDC-TEPT) es una terapia centrada en el trauma que ha mostrado una reducción de los síntomas centrales del TEPT, tales como intrusiones, hiperactivación, y evitación. Resultados preliminares indican efectos sobre elevadas emociones relacionadas con el trauma (por ej., culpa y vergüenza) y la aceptación posiblemente radical del evento traumático. Sin embargo, no es claro si las mejoras en estas variables son significativas luego de controlar los cambios en los síntomas centrales del TEPT y en qué medida se obtienen niveles no clínicos. En el presente estudio, 42 individuos que cumplieron con los criterios para el TEPT luego de un abuso infantil y que participaron en un programa residencial de la TDC-TEPT por 3 meses fueron evaluados al principio de su etapa de exposición a la TDC-TEPT y al final del tratamiento; una muestra no clínica con una historia de abuso infantil fue el grupo de referencia. Análisis multivariados de varianza y análisis multivariados de covarianza controlando los cambios en los síntomas centrales del TEPT fueron usados para evaluar los cambios en diferentes emociones relacionadas al trauma elevadas (temor, rabia, culpa, vergüenza, disgusto, tristeza, y desesperanza) y una aceptación radical. En los análisis multivariados de la varianza de medidas repetidas, las elevadas emociones relacionadas al trauma y la aceptación radical mejoraron significativamente durante la TDC-TEPT, λ = 0.34, p < .001; η2 = .56; t(40) = -5.66, p < .001, SMD = 0.88, incluso luego de controlar por los cambios en los síntomas del TEPT, λ = 0.35, p < .001, η2 = .65; Λ = 0.86, p = .018, η2 = .14, respectivamente. Al término del tratamiento, 31.0% (para aceptación) al 76.2% (para culpa) de los participantes mostraron niveles no clínicos de los resultados investigados, sugiriendo que tanto las emociones relacionadas con el trauma como la aceptación radical, cambió luego del programa residencial de la TDC-TEPT por 3 meses.

Alcohol screening and assessment measures for young people: A systematic review and meta-analysis of validation studies.

BACKGROUND: There is a strong rationale for clinicians to identify risky drinking among young people given the harms caused by alcohol. This systematic review evaluates the quality of evidence in the validation literature on alcohol screening and assessment measures for young people under 25. METHODS: Six electronic databases (MEDLINE; EMBASE; PsycINFO; SSCI; HMIC; ADAI) were searched in May 2016 for published and grey literature. Full-text reports published in English since 1980 were included if they aimed to validate an alcohol screening or assessment measure in comparison with a previously validated alcohol measure. Risk of bias was assessed in studies surpassing a priori quality thresholds for predictive validity, internal and test-retest reliability using COSMIN and QUADAS-2. RESULTS: Thirty nine reports comprising 135 discrete validation studies were included. Summary estimates indicated that the screening instruments performed well - AUC 0.91 (95% CI: 0.88 to 0.93); sensitivity 0.98 (0.95 to 0.99); specificity 0.78 (0.74 to 0.82). Noting a paucity of validation evidence for existing assessment instruments, aggregated reliability estimates suggest a reliability of 0.81 (0.78 to 0.83) adjusted for 10 items. Risk of bias was high for both types of studies. CONCLUSIONS: The volume and quality of available evidence are superior for screening measures. It is recommended that clinicians use alcohol frequency or quantity items if asking a single question. If there is an opportunity to ask more questions either the 3-item AUDIT-C or the 10-item AUDIT are recommended. There is a need to develop new instruments to assess young people's alcohol-related problems.

Health-related quality-of-life assessment in dementia: Evidence of cross-cultural validity in Latin America.

All health-related quality-of-life (HRQL) measures for dementia have been developed in high-income countries and none were validated for cross-cultural use. Yet, the global majority of people living with dementia reside in low- and middle-income countries. We therefore investigated the measurement invariance of a set of self- and informant-report HRQL measures developed in the United Kingdom when used in Latin America. Self-reported HRQL was obtained using (DEMQOL) at a memory assessment service in the United Kingdom (n = 868) and a population cohort study in Latin America (n = 417). Informant reports were collected using DEMQOL-Proxy at both sites (n = 909 and n = 495). Multiple-group confirmatory bifactor models for ordered categorical item responses were estimated to evaluate measurement invariance. Results support configural, metric, and scalar invariance for the concept of general HRQL in DEMQOL and DEMQOL-Proxy. The dominant impact of general HRQL on item responses was evident across U.K. English and Ibero American Spanish versions of DEMQOL (ωh = 0.87-0.90) and DEMQOL-Proxy (ωh = 0.88-0.89). Ratings of "positive emotion" did not show a major impact on general HRQL appraisal, particularly for Latin American respondents. Item information curves show that self- and informant-reports were highly informative about the presence rather than the absence of HRQL impairment. We found no major difference in conceptual meaning, sensitivity, and relevance of DEMQOL and DEMQOL-Proxy for older adults in the United Kingdom and Latin America. Further replication is needed for consensus over which HRQL measures are appropriate for making cross-national comparisons in global dementia research. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Measuring the Activity of Mental Health Services in England: Variation in Categorising Activity for Payment Purposes.

In the context of international interest in reforming mental health payment systems, national policy in England has sought to move towards an episodic funding approach. Patients are categorised into care clusters, and providers will be paid for episodes of care for patients within each cluster. For the payment system to work, clusters need to be appropriately homogenous in terms of financial resource use. We examine variation in costs and activity within clusters and across health care providers. We find that the large variation between providers with respect to costs within clusters mean that a cluster-based episodic payment system would have substantially different financial impacts across providers.

Transdiagnostic dimensions of psychosis in the Bipolar-Schizophrenia Network on Intermediate Phenotypes (B-SNIP).

The validity of the classification of non-affective and affective psychoses as distinct entities has been disputed, but, despite calls for alternative approaches to defining psychosis syndromes, there is a dearth of empirical efforts to identify transdiagnostic phenotypes of psychosis. We aimed to investigate the validity and utility of general and specific symptom dimensions of psychosis cutting across schizophrenia, schizoaffective disorder and bipolar I disorder with psychosis. Multidimensional item-response modeling was conducted on symptom ratings of the Positive and Negative Syndrome Scale, Young Mania Rating Scale, and Montgomery-Åsberg Depression Rating Scale in the multicentre Bipolar-Schizophrenia Network on Intermediate Phenotypes (B-SNIP) consortium, which included 933 patients with a diagnosis of schizophrenia (N=397), schizoaffective disorder (N=224), or bipolar I disorder with psychosis (N=312). A bifactor model with one general symptom dimension, two distinct dimensions of non-affective and affective psychosis, and five specific symptom dimensions of positive, negative, disorganized, manic and depressive symptoms provided the best model fit. There was further evidence on the utility of symptom dimensions for predicting B-SNIP psychosis biotypes with greater accuracy than categorical DSM diagnoses. General, positive, negative and disorganized symptom dimension scores were higher in African American vs. Caucasian patients. Symptom dimensions accurately classified patients into categorical DSM diagnoses. This study provides evidence on the validity and utility of transdiagnostic symptom dimensions of psychosis that transcend traditional diagnostic boundaries of psychotic disorders. Findings further show promising avenues for research at the interface of dimensional psychopathological phenotypes and basic neurobiological dimensions of psychopathology.

Funding approaches for mental health services: Is there still a role for clustering?

Funding for mental health services in England faces many challenges including operating under financial constraints where it is not easy to demonstrate the link between activity and funding. Mental health services need to operate alongside and collaborate with acute hospital services where there is a well-established system for paying for activity. The funding landscape is shifting at a rapid pace and we outline the distinctions between the three main options - block contracts, episodic payment and capitation. Classification of treatment episodes via clustering presents an opportunity to demonstrate activity and reward it within these payment approaches. We have been engaged in research to assess how well the clustering system is performing against a number of fundamental criteria. Clusters need to be reliably recorded, to correspond to health needs, and to treatments that require roughly similar resources. We find that according to these criteria, clusters are falling short of providing a sound basis for measuring and financing services. Yet, we argue, it is the best available option and is essential for a more transparent funding approach for mental health to demonstrate its claim on resources, and that, as such, clusters should be a starting point for evolving a better funding system.

What is the effect of secondary (high) schooling on subsequent medical school performance? A national, UK-based, cohort study.

OBJECTIVES: University academic achievement may be inversely related to the performance of the secondary (high) school an entrant attended. Indeed, some medical schools already offer 'grade discounts' to applicants from less well-performing schools. However, evidence to guide such policies is lacking. In this study, we analyse a national dataset in order to understand the relationship between the two main predictors of medical school admission in the UK (prior educational attainment (PEA) and performance on the United Kingdom Clinical Aptitude Test (UKCAT)) and subsequent undergraduate knowledge and skills-related outcomes analysed separately. METHODS: The study was based on national selection data and linked medical school outcomes for knowledge and skills-based tests during the first five years of medical school. UKCAT scores and PEA grades were available for 2107 students enrolled at 18 medical schools. Models were developed to investigate the potential mediating role played by a student's previous secondary school's performance. Multilevel models were created to explore the influence of students' secondary schools on undergraduate achievement in medical school. RESULTS: The ability of the UKCAT scores to predict undergraduate academic performance was significantly mediated by PEA in all five years of medical school. Undergraduate achievement was inversely related to secondary school-level performance. This effect waned over time and was less marked for skills, compared with undergraduate knowledge-based outcomes. Thus, the predictive value of secondary school grades was generally dependent on the secondary school in which they were obtained. CONCLUSIONS: The UKCAT scores added some value, above and beyond secondary school achievement, in predicting undergraduate performance, especially in the later years of study. Importantly, the findings suggest that the academic entry criteria should be relaxed for candidates applying from the least well performing secondary schools. In the UK, this would translate into a decrease of approximately one to two A-level grades.

Individual treatment selection for patients with posttraumatic stress disorder.

BACKGROUND: Trauma-focused cognitive behavioral therapy (Tf-CBT) and eye movement desensitization and reprocessing (EMDR) are two highly effective treatment options for posttraumatic stress disorder (PTSD). Yet, on an individual level, PTSD patients vary substantially in treatment response. The aim of the paper is to test the application of a treatment selection method based on a personalized advantage index (PAI). METHOD: The study used clinical data for patients accessing treatment for PTSD in a primary care mental health service in the north of England. PTSD patients received either EMDR (N = 75) or Tf-CBT (N = 242). The Patient Health Questionnaire (PHQ-9) was used as an outcome measure for depressive symptoms associated with PTSD. Variables predicting differential treatment response were identified using an automated variable selection approach (genetic algorithm) and afterwards included in regression models, allowing the calculation of each patient's PAI. RESULTS: Age, employment status, gender, and functional impairment were identified as relevant variables for Tf-CBT. For EMDR, baseline depressive symptoms as well as prescribed antidepressant medication were selected as predictor variables. Fifty-six percent of the patients (n = 125) had a PAI equal or higher than one standard deviation. From those patients, 62 (50%) did not receive their model-predicted treatment and could have benefited from a treatment assignment based on the PAI. CONCLUSIONS: Using a PAI-based algorithm has the potential to improve clinical decision making and to enhance individual patient outcomes, although further replication is necessary before such an approach can be implemented in prospective studies.

Some recommendations for developing multidimensional computerized adaptive tests for patient-reported outcomes.

PURPOSE: Multidimensional item response theory and computerized adaptive testing (CAT) are increasingly used in mental health, quality of life (QoL), and patient-reported outcome measurement. Although multidimensional assessment techniques hold promises, they are more challenging in their application than unidimensional ones. The authors comment on minimal standards when developing multidimensional CATs. METHODS: Prompted by pioneering papers published in QLR, the authors reflect on existing guidance and discussions from different psychometric communities, including guidelines developed for unidimensional CATs in the PROMIS project. RESULTS: The commentary focuses on two key topics: (1) the design, evaluation, and calibration of multidimensional item banks and (2) how to study the efficiency and precision of a multidimensional item bank. The authors suggest that the development of a carefully designed and calibrated item bank encompasses a construction phase and a psychometric phase. With respect to efficiency and precision, item banks should be large enough to provide adequate precision over the full range of the latent constructs. Therefore CAT performance should be studied as a function of the latent constructs and with reference to relevant benchmarks. Solutions are also suggested for simulation studies using real data, which often result in too optimistic evaluations of an item bank's efficiency and precision. DISCUSSION: Multidimensional CAT applications are promising but complex statistical assessment tools which necessitate detailed theoretical frameworks and methodological scrutiny when testing their appropriateness for practical applications. The authors advise researchers to evaluate item banks with a broad set of methods, describe their choices in detail, and substantiate their approach for validation.

Does service timing matter for psychological outcomes in cardiac rehabilitation? Insights from the National Audit of Cardiac Rehabilitation.

Background The presence of mental health conditions in cardiac rehabilitation (CR) patients such as anxiety and depression can lead to reduced programme adherence, increased mortality and increased re-occurrence of cardiovascular events undermining the aims and benefit of CR. Earlier research has identified a relationship between delayed commencement of CR and poorer physical activity outcomes. This study wished to explore whether a similar relationship between CR wait time and mental health outcomes can be found and to what degree participation in CR varies by mental health status. Methods Data from the UK National Audit of Cardiac Rehabilitation, a dataset that captures information on routine CR practice and patient outcomes, was extracted between 2012 and 2016. Logistic and multinomial regression models were used to explore the relationship between timing of CR and mental health outcomes measured on the hospital anxiety and depression scale. Results The results of this study showed participation in CR varied by mental health status, particularly in relation to completion of CR, with a higher proportion of non-completers with symptoms of anxiety (5% higher) and symptoms of depression (8% higher). Regression analyses also revealed that delays to CR commencement significantly impact mental health outcomes post-CR. Conclusion In these analyses CR wait time has been shown to predict the outcome of anxiety and depression status to the extent that delays in starting CR are detrimental. Programmes falling outside the 4-week window for commencement of CR following referral must strive to reduce wait times to avoid negative impacts to patient outcome.

Trauma-related emotions and radical acceptance in dialectical behavior therapy for posttraumatic stress disorder after childhood sexual abuse.

BACKGROUND: Posttraumatic Stress Disorder (PTSD) related to childhood sexual abuse (CSA) is often associated with a wide range of trauma-related aversive emotions such as fear, disgust, sadness, shame, guilt, and anger. Intense experience of aversive emotions in particular has been linked to higher psychopathology in trauma survivors. Most established psychosocial treatments aim to reduce avoidance of trauma-related memories and associated emotions. Interventions based on Dialectical Behavior Therapy (DBT) also foster radical acceptance of the traumatic event. METHODS: This study compares individual ratings of trauma-related emotions and radical acceptance between the start and the end of DBT for PTSD (DBT-PTSD) related to CSA. We expected a decrease in trauma-related emotions and an increase in acceptance. In addition, we tested whether therapy response according to the Clinician Administered PTSD-Scale (CAPS) for the DSM-IV was associated with changes in trauma-related emotions and acceptance. The data was collected within a randomized controlled trial testing the efficacy of DBT-PTSD, and a subsample of 23 women was included in this secondary data analysis. RESULTS: In a multilevel model, shame, guilt, disgust, distress, and fear decreased significantly from the start to the end of the therapy whereas radical acceptance increased. Therapy response measured with the CAPS was associated with change in trauma-related emotions. CONCLUSIONS: Trauma-related emotions and radical acceptance showed significant changes from the start to the end of DBT-PTSD. Future studies with larger sample sizes and control group designs are needed to test whether these changes are due to the treatment. TRIAL REGISTRATION: ClinicalTrials.gov, number NCT00481000.

A systematic review of alcohol screening and assessment measures for young people: a study protocol.

INTRODUCTION: Alcohol consumption creates a significant public health burden, and young people who drink alcohol place themselves at risk of harm. Expert guidance and reviews have highlighted the pressing need for reliable and valid, age-appropriate alcohol screening and assessment measures for young people. The proposed systematic review will evaluate existing alcohol screening and assessment measures for young people aged 24 and under. METHODS AND ANALYSIS: Six electronic databases will be searched for published and grey literature. In addition, reverse and forward citation searching and consultation with experts will be performed. Three sets of search terms will be combined, including alcohol use/problems, young people and validation studies. The titles and abstracts of reports from the searches will be screened, and potentially relevant full-text reports will be retrieved and independently assessed for inclusion by two reviewers based on prespecified criteria. Discrete validation studies within included reports will then be assessed for eligibility. There will be an a priori basic quality threshold for predictive validity, internal and test-retest for studies to warrant full data extraction. Studies above the quality threshold will be assessed for quality using the modified consensus-based standards for the selection of health measurement instruments checklist and a quality assessment tool for diagnostic accuracy studies. DISSEMINATION: This review will highlight the best performing measures both for screening and assessment based on their psychometric properties and the quality of the validation studies supporting their use. Providing clear guidance on which existing measures perform best to screen and assess alcohol use and problems in young people will inform policy, practice and decision-making, and clarify the need for further research. TRIAL REGISTRATION NUMBER: International Prospective Register of Systematic Reviews, CRD42016053330.

A core outcome set for evaluating self-management interventions in people with comorbid diabetes and severe mental illness: study protocol for a modified Delphi study and systematic review.

BACKGROUND: People with diabetes and comorbid severe mental illness (SMI) form a growing population at risk of increased mortality and morbidity compared to those with diabetes or SMI alone. There is increasing interest in interventions that target diabetes in SMI in order to help to improve physical health and reduce the associated health inequalities. However, there is a lack of consensus about which outcomes are important for this comorbid population, with trials differing in their focus on physical and mental health. A core outcome set, which includes outcomes across both conditions that are relevant to patients and other key stakeholders, is needed. METHODS: This study protocol describes methods to develop a core outcome set for use in effectiveness trials of self-management interventions for adults with comorbid type-2 diabetes and SMI. We will use a modified Delphi method to identify, rank, and agree core outcomes. This will comprise a two-round online survey and multistakeholder workshops involving patients and carers, health and social care professionals, health care commissioners, and other experts (e.g. academic researchers and third sector organisations). We will also select appropriate measurement tools for each outcome in the proposed core set and identify gaps in measures, where these exist. DISCUSSION: The proposed core outcome set will provide clear guidance about what outcomes should be measured, as a minimum, in trials of interventions for people with coexisting type-2 diabetes and SMI, and improve future synthesis of trial evidence in this area. We will also explore the challenges of using online Delphi methods for this hard-to-reach population, and examine differences in opinion about which outcomes matter to diverse stakeholder groups. TRIAL REGISTRATION: COMET registration: http://www.comet-initiative.org/studies/details/911 . Registered on 1 July 2016.