Elaine Brohan

Objectives: In this context the MASC study aimed to: (1) identify the consequences of the pandemic for mental health services and people with pre-existing mental health conditions (MHCs) in 6 low- and middle-income countries; and (2) identify good practice to mitigate these impacts. Design: An observational study, using a mixed-methods convergent design triangulating data from (1) semi-structured interviews or focus groups and/or a self-completed survey; (2) routine service utilization data; (3) local grey literature; and (4) expert consultation. Setting: The study was conducted in Chile, Ethiopia, Georgia, Nigeria, South Africa and Sri Lanka. Participants: 121 key informants. Results: We found clear evidence in all sites that the pandemic exacerbated pre-existing disadvantages experienced by people with MHCs and led to a deterioration in the availability and quality of care, especially for psychosocial care. Alongside increased vulnerability to COVID-19, people with MHCs faced additional barriers to accessing prevention and treatment interventions compared to the general population. To varying extents, sites showed accelerated implementation of digital technologies, but with evidence of worsening inequities in access. Where primary care-based mental health care was more developed or prioritised, systems seemed more resilient and adaptive. Conclusion: Our findings have the following implications. First, mental health service reductions are clear examples of ‘structural stigma’, namely policy level decisions in healthcare which place a low priority upon services for people with MHCs. Second, integration of mental health care into all general health care settings is key to ensuring accessibility and parity of physical and mental health care. Third, digital innovations should be designed to strengthen and not fragment systems. We discuss these findings in terms of anticipating such challenges in future and preparing layers of resilience. Methodological Strengths and Limitations of this Study: The MASC study used a mixed-methods convergent design , incorporating both quantitative and qualitative data, which allowed for a nuanced understanding of the COVID-19 pandemic impact on mental health services across multiple countries. This design enabled our study to triangulate data capturing both numerical trends and in-depth perspectives, increasing the validity and reliability of the findings. The study covered six diverse low- and middle-income countries across five continents , enabling cross-country comparisons and insights into varied socio-cultural and economic contexts. This geographic diversity strengthens the study’s generalisability to other settings with similar resource constraints. A mixture of online and in-person data collection in local languages was employed, overcoming pandemic-related barriers and enhancing accessibility for participants across the regions, which minimised data collection disruptions. The study faced limitations in obtaining comparable quantitative data across countries , with concerns about the accuracy and reliability of routine data. Reliance on national experts may have introduced potential biases if experts were not fully representative of the wider mental health context.

Background: Severe mental disorders – such as schizophrenia, bipolar disorder, and substance use disorders – exert a negative impact not only on affected people but also on their carers. To support carers of people with severe mental disorders, several psychosocial interventions have been developed. Methods: This systematic review and meta-analysis aimed to assess whether psychosocial interventions for carers of persons with schizophrenia, bipolar disorder, or substance use disorders produce benefit/harm with respect to a series of outcomes – including subjective and objective burden, depressive symptoms, well-being/quality of life, sleep, skills/knowledge, self-efficacy, physical health – as compared to standard support/support as usual or other control conditions. Results: In carers of persons with schizophrenia, psychoeducational interventions were associated with significant improvement in personal burden, well-being, and knowledge about the illness; and a supportive-educational intervention with an improvement in personal burden. In carers of persons with bipolar disorder, psychoeducational interventions were associated with significant improvement in personal burden and depressive symptoms; family-led supportive interventions with an improvement in family burden; family-focused intervention and online “mi.spot” intervention with a significant reduction in depressive symptoms. Psychosocial interventions used for carers of persons with substance use disorders were found to be overall effective on the level of well-being, but the low number of trials did not allow detection of differences between the various psychosocial interventions. Conclusions: The quality of the evidence ranged from very low to moderate, suggesting the need for further better-quality research.

Background: The Discrimination and Stigma Scale (DISC) is a patient-reported outcome measure which assesses experiences of discrimination among persons with a mental illness globally.Methods: This study evaluated whether the psychometric properties of a short-form version, DISC-Ultra Short (DISCUS) (11-item), could be replicated in a sample of people with a wide range of mental disorders from 21 sites in 15 countries/territories, across six global regions. The frequency of experienced discrimination was reported. Scaling assumptions (confirmatory factor analysis, inter-item and item-total correlations), reliability (internal consistency) and validity (convergent validity, known groups method) were investigated in each region, and by diagnosis group.Results: 1195 people participated. The most frequently reported experiences of discrimination were being shunned or avoided at work (48.7%) and discrimination in making or keeping friends (47.2%). Confirmatory factor analysis supported a unidimensional model across all six regions and five diagnosis groups. Convergent validity was confirmed in the total sample and within all regions [ Internalised Stigma of Mental Illness (ISMI-10): 0.28–0.67, stopping self: 0.54–0.72, stigma consciousness: −0.32–0.57], as was internal consistency reliability (α = 0.74–0.84). Known groups validity was established in the global sample with levels of experienced discrimination significantly higher for those experiencing higher depression [Patient Health Questionnaire (PHQ)-2: p < 0.001], lower mental wellbeing [Warwick-Edinburgh Well-being Scale (WEMWBS): p < 0.001], higher suicidal ideation [Beck Hopelessness Scale (BHS)-4: p < 0.001] and higher risk of suicidal behaviour [Suicidal Ideation Attributes Scale (SIDAS): p < 0.001].Conclusions: The DISCUS is a reliable and valid unidimensional measure of experienced discrimination for use in global settings with similar properties to the longer DISC. It offers a brief assessment of experienced discrimination for use in clinical and research settings.

Tuberous sclerosis complex (TSC) is a rare genetic disease associated with significant disease burden and considerable impact on health-related quality of life (HRQL). Currently no disease-specific clinical outcome assessments evaluate HRQL in individuals with TSC. A multi-center phase III study EXIST-3 (NCT01713946) assessed the efficacy and safety of two trough exposure ranges (Low exposure, LE: 3–7 ng/mL and high exposure, HE: 9–15 ng/mL) of adjunctive everolimus in patients aged 2–65 years with TSC and refractory partial-onset seizures (N = 366). Three age-specific HRQL measures were included as secondary endpoints including: quality of life in childhood epilepsy (QOLCE; caregiver-report for aged 2- < 11), the Quality of Life in Epilepsy Inventory for Adolescents-48 (QOLIE-AD-48; self-report, aged ≥ 11- < 18), and the Quality of Life in Epilepsy Inventory-31-Problems (QOLIE-31-P; self-report, aged ≥ 18). Intellectual ability was evaluated using the Wechsler Non-Verbal (WNV) Scale of Ability. Post hoc analyses were performed on the core phase primary data from EXIST-3 to evaluate the psychometric properties of the HRQL measures and calculate meaningful change estimates. Results showed that a significant subset of the trial sample (4–21 year olds) scored in the intellectual disability range, as assessed by the WNV. Psychometric analyses of the three epilepsy measures (including reliability, validity, and ability to detect change) supported the appropriateness for use in TSC. Distribution-based meaningful change estimates were generated for each HRQL measure, with estimates for the QOLIE-31-P total score largely consistent with the published literature. To our knowledge, this is the first evaluation using clinical trial data to establish the psychometric properties of the QOLCE, QOLIE-AD-48, and QOLIE-31-P for use in individuals with TSC. These findings increase confidence in the measures as valid and reliable for use in clinical trials and future research in patients with TSC.

Introduction Despite reductions in rates of smoking in the past decade, smoking remains one of the most significant public health concerns. Quitting smoking can result in reductions in a number of serious health conditions. The brief Willingness to Quit (WTQ) tool can be used in routine clinical practice to assess current willingness to quit and engage a patient–physician dialogue regarding smoking cessation. The overall aim of this study was to validate the content of a WTQ tool for use with current smokers in clinical practice. Methods In-depth, qualitative interviews were conducted with 12 current smokers and five physicians. The interview was divided into two sections: concept elicitation (CE) followed by cognitive debriefing (CD). During CE, participants were asked questions exploring the different factors that can impact an individual’s willingness to quit smoking. During CD, participants were given a copy of the WTQ tool and asked to comment on their level of understanding and interpretability of the items and the feasibility of completing the tool in clinical practice. Results All of the current smokers (n = 12) and physicians (n = 5) interviewed indicated that the items were understandable and relevant to assess willingness to quit. The tool was considered simple and suitable for use in clinical practice. Conclusion The WTQ tool is a brief tool to assess willingness to quit and to engage communication between patients and physicians. All smokers should be offered smoking cessation support and facilitating a discussion on willingness to quit further supports a personalized quit plan. Funding Pfizer Inc.

Introduction: Adherence to haemophilia A (HA) treatment may be influenced by patients’ beliefs about their condition and treatment. Furthermore, difficulties administering treatment may lead to poor adherence. New treatment strategies aim to reduce the burden associated with administration and to improve patient perception of treatment, which, in turn, increase adherence levels.Aims: This study aimed to examine patient perception of HA treatment and related factors using patient‐reported outcome (PRO) questionnaires and to confirm the psychometric properties of a recently developed questionnaire, the HaemoPREF.Methods: A non‐interventional, cross‐sectional, questionnaire study was conducted with adult HA patients in Spain (n=31), Germany (n=10) and Italy (n=48), who were using ReFacto AF with the FuseNGo administration device. Patients completed the HaemoPREF and other questionnaires measuring related constructs: treatment adherence, satisfaction and well‐being, online at two time points. Correlational, regression and psychometric analyses were conducted.Results: PRO scores indicated that patients are satisfied with and adherent to their treatment. Multivariate regression of the HaemoPREF global score identified a number of significant predictors (P≤.05). The HaemoPREF Global Score had a moderate relationship with subscales on the related questionnaires (mean correlation=0.43; range=0.39‐0.48). The HaemoPREF demonstrated good test‐retest reliability (intraclass correlation coefficient=0.82), internal consistency reliability (Cronbach's alpha range=0.69‐0.82) and convergent validity with measures of treatment satisfaction (Spearman correlation coefficient, r=.48) and well‐being (r=.41).Conclusion: The findings suggest that patients using ReFacto AF with FuseNGo were satisfied with and adherent to their treatment. The HaemoPREF can identify important concepts relating to patient treatment experience in HA.

Summary: The value of adding simeprevir (SMV) vs placebo (PBO) to peginterferon and ribavirin (PR) for treatment of chronic hepatitis C virus infection was examined using patient‐reported outcomes (PROs); further, concordance of PROs with virology endpoints and adverse events (AEs) was explored. Patients (n = 768 SMV/PR, n = 393 PBO/PR) rated fatigue (FSS), depressive symptoms (CES‐D) and functional impairment (WPAI: Hepatitis C Productivity, Daily Activity and Absenteeism) at baseline and throughout treatment in three randomised, double‐blind trials comparing the addition of SMV or PBO during initial 12 weeks of PR. PR was administered for 48 weeks (PBO group) and 24/48 weeks (SMV group) using a response‐guided therapy (RGT) approach. Mean PRO scores (except Absenteeism) worsened from baseline to Week 4 to the same extent in both groups but reverted after Week 24 for SMV/PR and only after Week 48 for PBO/PR. Accordingly, there was a significantly lower area under the curve (baseline–Week 60, AUC₆₀) and fewer weeks with clinically important worsening of scores in the SMV/PR group at any time point. Incidences of patients with fatigue and anaemia AEs were similar in both groups, but FSS scores showed that clinically important increases in fatigue lasted a mean of 6.9 weeks longer with PBO/PR (P < 0.001). PRO score subgroup analysis indicated better outcomes for patients who met the criteria for RGT or achieved sustained virological response 12 weeks post‐treatment (SVR12); differences in mean PRO scores associated with fibrosis level were only observed with PBO/PR. Greater efficacy of SMV/PR enabled reduced treatment duration and reduced time with PR‐related AEs without adding to AE severity.