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?

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.

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.

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.

Impact of long-term medical conditions on the outcomes of psychological therapy for depression and anxiety.

BACKGROUND: Long-term conditions often coexist with depression and anxiety. AIMS: To assess the effectiveness of stepped-care psychological therapies for patients with long-term conditions. METHOD: Data from 28 498 patients were analysed using regression to model depression (Patient Health Questionnaire (PHQ-9)) and anxiety (Generalised Anxiety Disorder scale (GAD-7)) outcomes. Post-treatment symptoms and effect sizes (d) were estimated for individuals with and without long-term conditions, controlling for covariates. The likelihood of access and response to intensive psychological interventions was also examined. RESULTS: Higher post-treatment symptoms were predicted for patients with musculoskeletal problems (d = 0.22-0.27), chronic obstructive pulmonary disease (d = 0.26-0.33), diabetes (d = 0.05-0.13) and psychotic disorders (d = 0.50-0.58). Most long-term conditions were associated with greater odds of accessing high-intensity therapies, yet individuals who accessed these continued to have higher average post-treatment symptoms. CONCLUSIONS: Some long-term conditions are associated with greater intensity of care and poorer outcomes after therapy.

Does involvement in a cohort study improve health and affect health inequalities? A natural experiment.

BACKGROUND: Evidence suggests that the process of taking part in health research can improve participants' health, independent of any intended intervention. However, no research has yet explored whether these effects differ across socioeconomic groups. If the effect of mere participation in health research also has a social gradient this could increase health inequalities and bias research results. This study used the Born in Bradford family cohort (BIB) to explore whether simply taking part in BIB had improved participants' health and, if so, whether this effect was mediated by socioeconomic status. METHODS: Survey data on self-reported health behaviours were collected between 2007 and 2010 as part of BIB. These were augmented by clinical data on birth weight. Pregnant women on their second pregnancy, joining BIB for the first time formed the control group. Their health was compared to women on their second pregnancy who had both pregnancies within the study, who formed the exposed group. In order to limit the inherent bias in a non-randomised study, propensity score analysis was used, matching on age, ethnicity, education and date of questionnaire. The results were then compared according to mothers' education. RESULTS: Of six outcomes tested, only alcohol consumption showed a statistically significant reduction with exposure to BIB (OR: 0.35, 95% CIs 0.13, 0.92). Although effect estimates were larger for women with higher education compared to lower education, these effects were not statistically significant. CONCLUSIONS: Despite one significant finding, these results overall are insufficient to conclude that simply taking part in BIB affected participants' health. We recommend that socioeconomic status is considered in future studies testing effects of research participation, and that randomised studies with larger sample sizes are conducted.

Calibrating well-being, quality of life and common mental disorder items: psychometric epidemiology in public mental health research.

BACKGROUND: The assessment of 'general health and well-being' in public mental health research stimulates debates around relative merits of questionnaire instruments and their items. Little evidence regarding alignment or differential advantages of instruments or items has appeared to date. AIMS: Population-based psychometric study of items employed in public mental health narratives. METHOD: Multidimensional item response theory was applied to General Health Questionnaire (GHQ-12), Warwick-Edinburgh Mental Well-being Scale (WEMWBS) and EQ-5D items (Health Survey for England, 2010-2012; n = 19 290). RESULTS: A bifactor model provided the best account of the data and showed that the GHQ-12 and WEMWBS items assess mainly the same construct. Only one item of the EQ-5D showed relevant overlap with this dimension (anxiety/depression). Findings were corroborated by comparisons with alternative models and cross-validation analyses. CONCLUSIONS: The consequences of this lack of differentiation (GHQ-12 v. WEMWBS) for mental health and well-being narratives deserves discussion to enrich debates on priorities in public mental health and its assessment.

Evaluation of the validity and utility of a transdiagnostic psychosis dimension encompassing schizophrenia and bipolar disorder.

BACKGROUND: In recent years, the Kraepelinian dichotomy has been challenged in light of evidence on shared genetic and environmental factors for schizophrenia and bipolar disorder, but empirical efforts to identify a transdiagnostic phenotype of psychosis remain remarkably limited. AIMS: To investigate whether schizophrenia spectrum and bipolar disorder lie on a transdiagnostic spectrum with overlapping non-affective and affective psychotic symptoms. METHOD: Multidimensional item-response modelling was conducted on symptom ratings of the OPerational CRITeria (OPCRIT) system in 1168 patients with schizophrenia spectrum and bipolar disorder. RESULTS: A bifactor model with one general, transdiagnostic psychosis dimension underlying affective and non-affective psychotic symptoms and five specific dimensions of positive, negative, disorganised, manic and depressive symptoms provided the best model fit and diagnostic utility for categorical classification. CONCLUSIONS: Our findings provide support for including dimensional approaches into classification systems and a directly measurable clinical phenotype for cross-disorder investigations into shared genetic and environmental factors of psychosis.

An evaluation of computerized adaptive testing for general psychological distress: combining GHQ-12 and Affectometer-2 in an item bank for public mental health research.

BACKGROUND: Recent developments in psychometric modeling and technology allow pooling well-validated items from existing instruments into larger item banks and their deployment through methods of computerized adaptive testing (CAT). Use of item response theory-based bifactor methods and integrative data analysis overcomes barriers in cross-instrument comparison. This paper presents the joint calibration of an item bank for researchers keen to investigate population variations in general psychological distress (GPD). METHODS: Multidimensional item response theory was used on existing health survey data from the Scottish Health Education Population Survey (n = 766) to calibrate an item bank consisting of pooled items from the short common mental disorder screen (GHQ-12) and the Affectometer-2 (a measure of "general happiness"). Computer simulation was used to evaluate usefulness and efficacy of its adaptive administration. RESULTS: A bifactor model capturing variation across a continuum of population distress (while controlling for artefacts due to item wording) was supported. The numbers of items for different required reliabilities in adaptive administration demonstrated promising efficacy of the proposed item bank. CONCLUSIONS: Psychometric modeling of the common dimension captured by more than one instrument offers the potential of adaptive testing for GPD using individually sequenced combinations of existing survey items. The potential for linking other item sets with alternative candidate measures of positive mental health is discussed since an optimal item bank may require even more items than these.

Disentangling psychopathology, substance use and dependence: a factor analysis.

BACKGROUND: The notion that substance use can induce symptoms of depression and anxiety is influential in clinical practice, however questions remain about the empirical support for this hypothesis. METHODS: We analysed mental health and substance dependence screening records for 280 outpatients in addictions treatment. Item-level data for depression (PHQ-9), anxiety (GAD-7), severity of dependence (SDS) and self-reported weekly substance use were studied using factor analysis and correlations. Symptom-level associations between substance use and psychological distress symptoms were examined after controlling for underlying levels of psychopathology. RESULTS: We obtained a two-factor solution accounting for approximately 48 % of total variance. Depression and anxiety symptoms loaded onto a single psychopathology factor. Severity of dependence (SDS) and substance use measures loaded onto a distinct but correlated factor. After controlling for latent levels of psychopathology, the only remaining symptom-level associations were impaired concentration linked to cannabis use and irritability linked to alcohol use. Dependence (SDS) was prominently associated with depressive rumination, and negatively correlated with residual anxiety symptoms related to substance use (e.g., craving). CONCLUSIONS: Overall, this analysis supports a psychological understanding of comorbidity; with dependence, craving, negative reinforcement and rumination as key variables.

Computerized adaptive testing of population psychological distress: simulation-based evaluation of GHQ-30.

PURPOSE: Goldberg's General Health Questionnaire (GHQ) items are frequently used to assess psychological distress but no study to date has investigated the GHQ-30's potential for adaptive administration. In computerized adaptive testing (CAT) items are matched optimally to the targeted distress level of respondents instead of relying on fixed-length versions of instruments. We therefore calibrate GHQ-30 items and report a simulation study exploring the potential of this instrument for adaptive administration in a longitudinal setting. METHODS: GHQ-30 responses of 3445 participants with 2 completed assessments (baseline, 7-year follow-up) in the UK Health and Lifestyle Survey were calibrated using item response theory. Our simulation study evaluated the efficiency of CAT administration of the items, cross-sectionally and longitudinally, with different estimators, item selection methods, and measurement precision criteria. RESULTS: To yield accurate distress measurements (marginal reliability at least 0.90) nearly all GHQ-30 items need to be administered to most survey respondents in general population samples. When lower accuracy is permissible (marginal reliability of 0.80), adaptive administration saves approximately 2/3 of the items. For longitudinal applications, change scores based on the complete set of GHQ-30 items correlate highly with change scores from adaptive administrations. CONCLUSIONS: The rationale for CAT-GHQ-30 is only supported when the required marginal reliability is lower than 0.9, which is most likely to be the case in cross-sectional and longitudinal studies assessing mean changes in populations. Precise measurement of psychological distress at the individual level can be achieved, but requires the deployment of all 30 items.

Modelling verbal aggression, physical aggression and inappropriate sexual behaviour after acquired brain injury.

Understanding the underpinnings of behavioural disturbances following brain injury is of considerable importance, but little at present is known about the relationships between different types of behavioural disturbances. Here, we take a novel approach to this issue by using confirmatory factor analysis to elucidate the architecture of verbal aggression, physical aggression and inappropriate sexual behaviour using systematic records made across an eight-week observation period for a large sample (n = 301) of individuals with a range of brain injuries. This approach offers a powerful test of the architecture of these behavioural disturbances by testing the fit between observed behaviours and different theoretical models. We chose models that reflected alternative theoretical perspectives based on generalized disinhibition (Model 1), a difference between aggression and inappropriate sexual behaviour (Model 2), or on the idea that verbal aggression, physical aggression and inappropriate sexual behaviour reflect broadly distinct but correlated clinical phenomena (Model 3). Model 3 provided the best fit to the data indicating that these behaviours can be viewed as distinct, but with substantial overlap. These data are important both for developing models concerning the architecture of behaviour as well as for clinical management in individuals with brain injury.

Validity of single item responses to short message service texts to monitor depression: an mHealth sub-study of the UK ACUDep trial.

BACKGROUND: An increasing number of research designs are using text messaging (SMS) as a means of self-reported symptom and outcome monitoring in a variety of long-term health conditions, including severity ratings of depressed mood. The validity of such a single item SMS score to measure latent depression is not currently known and is vital if SMS data are to inform clinical evaluation in the future. METHODS: A sub-set of depressed participants in the UK ACUDep trial submitted a single SMS text score (R-SMS-DS) between 1 and 9 on how depressed they felt around the same time as completing the PHQ-9 depression questionnaire on paper at 3 months follow-up of the trial. Exploratory categorical data factor analysis (EFA) was used to ascertain the alignment of R-SMS-DS scores with the factor structure of the PHQ-9. Any response bias with regard to age or gender was assessed by differential item functioning (DIF) analysis. RESULTS: Depression scores based on the PHQ-9 and R-SMS-DS at 3 months were available for 337 participants (74 % female; mean age: 42 years, SD = 11.1), 213 of which completed the two outcomes within 6 days of each other. R-SMS-DS scores aligned with the underlying latent depression of the PHQ-9 (factor loading of 0.656) and in particular its affective rather than somatic dimension. The R-SMS-DS score was most strongly correlated with depressed mood (r = 0.607), feeling bad about oneself (r = 0.588) and anhedonia (r = 0.573). R-SMS-DS responses were invariant with respect to gender (p = 0.302). However, there was some evidence for age related response bias (p = 0.031), with older participants being more likely to endorse lower R-SMS-DS scores than younger ones. CONCLUSIONS: The R-SMS-DS used in the ACUDep trial was found to be a valid measure of latent affective depression with no gender related response bias. This text message item may therefore represent a useful assessment and monitoring tool meriting evaluation in further research. For future study designs we recommend the collection of outcome data by new health technologies in combination with gold standard instruments to ensure concurrent validity.

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.