Effectiveness, barriers, and facilitators of interventions delivered by traditional healers for the treatment of common mental disorders: A systematic review.

We investigated the effectiveness of interventions provided by traditional healers for common mental disorders (CMDs) together with associated barriers and facilitators. Electronic databases including MEDLINE, APA Psych Info, Allied and Complementary Medicine, Embase, CINAHL, Social Science Citation Index, and Scopus were searched from inception until October 2021. Randomised controlled trials (RCTs) assessing interventions by traditional healers for CMDs and qualitative and mixed-methods studies examining traditional healers and their attendees' views about the treatment of CMDs by traditional healers were included. Cochrane Risk of Bias Assessment tool (RoB-1) and Critical Appraisal Skills Programme (CASP) were used for the quality assessment of studies. A meta-analysis and thematic synthesis were conducted. Sixteen RCTs (1,132 participants) and 17 qualitative or mixed-methods studies (380 participants) were included. Improvement in symptoms was greater for interventions by traditional healers compared to control groups for both depression and anxiety. Subgroup analyses indicated that only "spiritual passe" interventions showed improvement in depression and anxiety, and participants with co-morbid anxiety and physical conditions showed improvement in anxiety. Facilitators to engaging with interventions by traditional healers were shared faith-based worldview exhibited by traditional healers and their attendees and perceived effectiveness of traditional healing. Stigma and concealing mental illness were found to be barriers not only to formal healthcare but also to traditional healers' services. Interventions by traditional healers such as "spiritual passe" are effective in improving CMDs. However, evidence is still limited due to the low quality of studies and lack of long-term evidence.

Depression care integration in tuberculosis services: A feasibility assessment in Pakistan.

BACKGROUND: The co-occurrence of depression among tuberculosis (TB) patients is a critical issue, contributing to poor treatment outcomes, prolonged hospitalisations and increased healthcare expenses. OBJECTIVE: The objective of this study was to assess the feasibility of delivering a co-designed depression care pathway within TB services in Pakistan. DESIGN: Mixed-method study. SETTING AND PARTICIPANTS: Routine depression screening for TB patients was conducted at three TB facilities in Peshawar, Pakistan, encompassing primary, secondary and tertiary care settings. All patients aged 18 or above (male and female) attending the three TB facilities between November 2021 and February 2022 were included in the study using the consecutive sampling technique. RESULTS: A total of 301 people with confirmed TB, within the past 4 weeks, visited the three TB care facilities; 191/301 patients were screened for depression. Approximately 35% of the 191 TB patients screened positive for depression, with varying severity levels. Qualitative findings highlighted the acceptability of integrated depression care, emphasising the importance of open communication and empathetic attitudes. Barriers to integration include stigma, logistical challenges, patient noncompliance and cost burdens. Facilitators included the empathetic attitude of healthcare providers and the availability of mental health services within the same facility. CONCLUSION: There is a high burden of depression in patients with TB, highlighting the pressing need for mental health support in this population. Acceptability of integrated care was evident, with factors such as co-located mental health services, training healthcare providers and provider empathetic attitudes playing a crucial role. Further research is required to evaluate the effectiveness of the integrated TB-depression screening systems towards improved health outcomes, implementation, scalability and impact on the broader healthcare system. PATIENT AND PUBLIC CONTRIBUTION: To create a more inclusive and comprehensive TB and depression care pathway, we gathered input from both service providers and service users (TB patients, their carers). Reflective meetings with community leaders, social activists and health professionals from various sectors were also conducted during pathway delivery to get their insights. Power, gender and age imbalances were addressed by encouraging participation of patients and carers across gender and age groups. This approach ensured that the perspectives of all stakeholders were considered in the development of the care pathway.

Collaborative care for common mental disorders in low- and middle-income countries: A systematic review and meta-analysis.

BACKGROUND: Low- and middle-income countries (LMICs) face high burden of common mental disorders (CMDs). Most of the evidence for the Collaborative Care (CC) model effectiveness comes from high-income countries (HICs) and may not generalise to LMICs. A systematic review was conducted to assess effectiveness of CC for CMDs in LMICs. METHODS: We searched eight-databases, two trial registries (2011-November 2023). Randomised controlled trials (RCTs) of adults (≥18 years) with depression/anxiety diagnosis, reporting remission/change in symptom severity were eligible. Random effects meta-analyses were conducted for: short-(0-6 months), medium-(7-12 months), long-(13-24 months), and very long-term (≥25 months) follow-up. Quality was assessed with Cochrane RoB2 tool. PROSPERO registration: CRD42022380407. RESULTS: Searches identified 7494 studies, 12 trials involving 13,531 participants were included; nine had low-risk of bias. CC was more effective than usual care for depression: dichotomous outcomes (short-term, 7 studies, relative risk (RR) 1.39, 95%CI 1.31, 1.48; medium-term, 6 studies, RR 1.35, 95%CI 1.28, 1.43); and continuous outcomes (short-term, 8 studies, standardised mean difference (SMD) -0.51, 95%CI -0.80, -0.23; medium-term, 8 studies, SMD -0.59, 95%CI -1.00, -0.17). CC was found to be effective at long-term (one study), but not at very long-term. Improvement in anxiety outcomes with CC (2 studies, 340 participants) reported up to 12-months; improvements in quality-of-life were not statistically significant (3 studies, 796 participants, SMD 0.62, 95%CI -0.10, 1.34). LIMITATIONS: Pooled estimates showed high heterogeneity. CONCLUSIONS: In LMICs, CC was more effective than usual care for improving depression outcomes at short and medium-term follow-up. A similar improvement was found for anxiety outcomes, but evidence is limited.

Assessing the uptake of incentivised physical health checks for people with serious mental illness: a cohort study in primary care.

BACKGROUND: People with serious mental illness are more likely to experience physical illnesses. The onset of many of these illnesses can be prevented if detected early. Physical health screening for people with serious mental illness is incentivised in primary care in England through the Quality and Outcomes Framework (QOF). GPs are paid to conduct annual physical health checks on patients with serious mental illness, including checks of body mass index (BMI), cholesterol, and alcohol consumption. AIM: To assess the impact of removing and reintroducing QOF financial incentives on uptake of three physical health checks (BMI, cholesterol, and alcohol consumption) for patients with serious mental illness. DESIGN AND SETTING: Cohort study using UK primary care data from the Clinical Practice Research Datalink between April 2011 and March 2020. METHOD: A difference-in-difference analysis was employed to compare differences in the uptake of physical health checks before and after the intervention, accounting for relevant observed and unobserved confounders. RESULTS: An immediate change was found in uptake after physical health checks were removed from, and after they were added back to, the QOF list. For BMI, cholesterol, and alcohol checks, the overall impact of removal was a reduction in uptake of 14.3, 6.8, and 11.9 percentage points, respectively. The reintroduction of BMI screening in the QOF increased the uptake by 10.2 percentage points. CONCLUSION: This analysis supports the hypothesis that QOF incentives lead to better uptake of physical health checks.

Improving the Detection, Assessment, Management and Prevention of Delirium in Hospices (the DAMPen-D study): Feasibility study of a flexible and scalable implementation strategy to deliver guideline-adherent delirium care.

BACKGROUND: Delirium is a complex condition, stressful for all involved. Although highly prevalent in palliative care settings, it remains underdiagnosed and associated with poor outcomes. Guideline-adherent delirium care may improve its detection, assessment and management. AIM: To inform a future definitive study that tests whether an implementation strategy designed to improve guideline-adherent delirium care in palliative care settings improves patient outcomes (reduced proportion of in-patient days with delirium). DESIGN: With Patient Involvement members, we conducted a feasibility study to assess the acceptability of and engagement with the implementation strategy by hospice staff (intervention), and whether clinical record data collection of process (e.g. guideline-adherent delirium care) and clinical outcomes (evidence of delirium using a validated chart-based instrument;) pre- and 12-weeks post-implementation of the intervention would be possible. SETTING/PARTICIPANTS: In-patient admissions in three English hospices. RESULTS: Between June 2021 and December 2022, clinical record data were extracted from 300 consecutive admissions. Despite data collection during COVID-19, target clinical record data collection (n = 300) was achieved. Approximately two-thirds of patients had a delirium episode during in-patient stay at both timepoints. A 6% absolute reduction in proportion of delirium days in those with a delirium episode was observed. Post-implementation improvements in guideline-adherent metrics include: clinical delirium diagnosis 15%-28%; delirium risk assessment 0%-16%; screening on admission 7%-35%. CONCLUSIONS: Collection of data on delirium outcomes and guideline-adherence from clinical records is feasible. The signal of patient benefit supports formal evaluation in a large-scale study.

Core outcome sets for trials of interventions to prevent and to treat multimorbidity 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. A core outcome set (COS) appropriate for the study of multimorbidity in LMIC contexts does not presently exist. This is 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 the prevention and treatment of multimorbidity 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 with representation from 33 countries (people with multimorbidity/caregivers, multimorbidity researchers, healthcare professionals, and policy makers). 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 six treatment outcomes were added from Delphi round one. Delphi round two surveys were completed by 95 of 132 round one 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 LMIC contexts. We recommend their inclusion in future trials to meaningfully advance the field of multimorbidity research in LMICs.

Living with depression and diabetes: A qualitative study in Bangladesh and Pakistan.

Diabetes and depression are both serious health conditions. While their relationship is bidirectional and each condition adversely affects outcomes for the other, they are treated separately. In low and middle income countries, such as Bangladesh and Pakistan, health systems are already stretched and the integration of diabetes and depression care is rarely a priority. Within this context through interviews with patients, healthcare workers and policy makers the study explored: lived experiences of people living with depression and diabetes, current practice in mental health and diabetes care and barriers and perspectives on integrating a brief psychological therapy into diabetes care. The findings of the study included: differing patient and practitioner understandings of distress/depression, high levels of stigma for mental health and a lack of awareness and training on treating depression. While it was apparent there is a need for more holistic care and the concept of a brief psychological intervention appeared acceptable to participants, many logistical barriers to integrating a mental health intervention into diabetes care were identified. The study highlights the importance of context and of recognising drivers and understandings of distress when planning for more integrated mental and physical health services, and specifically when adapting and implementing a new intervention into existing services.

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.

Self-management of chronic, non-communicable diseases in South Asian settings: A systematic mixed-studies review.

Self-management is crucial in mitigating the impacts of a growing non-communicable disease (NCD) burden, particularly in Low and Middle-Income countries. What influences self-management in these settings, however, is poorly understood. We aimed to identify the determinants of self-management in the high NCD region of South Asia and explore how they influence self-management. A systematic mixed-studies review was conducted. Key electronic databases [MEDLINE (1946+), Embase (1974+), PsycInfo (1967+) and CINAHL (EBSCOhost)] in March 2022 (and updated in April 2023) were searched for studies on the self-management of four high-burden NCD groups: cardiovascular diseases, type 2 diabetes, chronic respiratory diseases and depression. Study characteristics and quantitative data were extracted using a structured template, and qualitative information was extracted using NVivo. Quality appraisal was done using the Mixed Methods Assessment Tool (MMAT). Quantitative findings were organised using the Commission on Social Determinants of Health (CSDH) framework and synthesised narratively, supported by effect direction plots. Qualitative findings were thematically synthesised. Both were integrated in a mixed synthesis. Forty-four studies (26 quantitative, 16 qualitative and 2 mixed-methods studies) were included, the majority of which were conducted in urban settings and among individuals with diabetes and cardiovascular diseases. Higher age, education, and income (structural determinants), health-related knowledge, social support and self-efficacy (psychosocial determinants), longer illness duration and physical comorbidity (biologic determinants), and the affordability of medicine (health-system determinants) were key determinants of self-management. Qualitative themes highlighted the role of financial adversity and the social and physical environment in shaping self-management.A complex interplay of structural and intermediary social determinants shapes self-management in South Asian settings. Multi-component, whole-systems approaches could boost self-management in these settings. Key areas include empowerment and education of patients and wider community, design and delivery of bespoke behavioural interventions and a stronger emphasis on supporting self-management in healthcare settings.

Positive thinking about negative studies.

The non-reporting of negative studies results in a scientific record that is incomplete, one-sided and misleading. The consequences of this range from inappropriate initiation of further studies that might put participants at unnecessary risk to treatment guidelines that may be in error, thus compromising day-to-day clinical practice.

Tobacco use in people with severe mental illness: Findings from a multi-country survey of mental health institutions in South Asia.

INTRODUCTION: People with severe mental illness (SMI) tend to die early due to cardiovascular and respiratory diseases, which may be linked to tobacco use. There is limited information on tobacco use in people with SMI in low- and middle-income countries where most tobacco users reside. We present novel data on tobacco use in people with SMI and their access to tobacco cessation advice in South Asia. METHODS: We conducted a multi-country survey of adults with SMI attending mental health facilities in Bangladesh, India, and Pakistan. Using data collected with a standardized WHO STEPS survey tool, we estimated the prevalence and distribution of tobacco use and assessed receipt of tobacco cessation advice. RESULTS: We recruited 3874 participants with SMI; 46.8% and 15.0% of men and women consumed tobacco, respectively. Smoking prevalence in men varied by country (Bangladesh 42.8%, India 20.1% and Pakistan 31.7%); <4% of women reported smoking in each country. Smokeless tobacco use in men also varied by country (Bangladesh 16.2%, India 18.2% and Pakistan 40.8%); for women, it was higher in Bangladesh (19.1%), but similar in India (9.9%) and Pakistan (9.1%). Just over a third of tobacco users (38.4%) had received advice to quit tobacco. Among smokers, 29.1% (n=244) made at least one quit attempt in the past year. There was strong evidence for the association between tobacco use and the severity of depression (OR=1.29; 95% CI: 1.12-1.48) and anxiety (OR=1.29; 95% CI: 1.12-1.49). CONCLUSIONS: As observed in high-income countries, we found higher tobacco use in people with SMI, particularly in men compared with rates reported for the general population in South Asia. Tobacco cessation support within mental health services offers an opportunity to close the gap in life expectancy between SMI and the general population. STUDY REGISTRATION: ISRCTN88485933; https://doi.org/10.1186/ISRCTN88485933 39.

Effectiveness and implementation of psychological interventions for depression in people with non-communicable diseases in South Asia: Systematic review and meta-analysis.

We evaluate the effectiveness of psychological interventions for depression in people with NCDs in South Asia and explore the individual, organizational, and policy-level barriers and facilitators for the implementation and scaling up of these interventions. Eight databases (and local web pages) were searched in May 2022. We conducted random effects models to evaluate the pooled effect of psychological interventions on depression in people with NCDs. We extracted the individual, organizational, and policy level barriers and facilitators. We found five randomized control trials, nine qualitative studies, and 35 policy documents that fitted the inclusion criteria. The pooled standardized mean difference in depression comparing psychological interventions with usual care was -2.31 (95% CI, -4.16 to -0.45; p = .015, I2 = 96.0%). We found barriers and facilitators to intervention delivery, mental health appears in the policy agenda in Bangladesh and Pakistan. However, there is a lack of policies relating to training in mental health for NCD health providers and a lack of integration of mental health care with NCD care. All of the psychological interventions reported to be effective in treating depression in this population. There are important delivery and policy barriers to the implementation and scaling up of psychological interventions for people with NCDs.

Risk factors associated with overweight and obesity in people with severe mental illness in South Asia: cross-sectional study in Bangladesh, India, and Pakistan.

Obesity is one of the major contributors to the excess mortality seen in people with severe mental illness (SMI) and in low- and middle-income countries people with SMI may be at an even greater risk. In this study, we aimed to determine the prevalence of obesity and overweight in people with SMI and investigate the association of obesity and overweight with sociodemographic variables, other physical comorbidities, and health-risk behaviours. This was a multi-country cross-sectional survey study where data were collected from 3989 adults with SMI from three specialist mental health institutions in Bangladesh, India, and Pakistan. The prevalence of overweight and obesity was estimated using Asian BMI thresholds. Multinomial regression models were then used to explore associations between overweight and obesity with various potential determinants. There was a high prevalence of overweight (17·3 %) and obesity (46·2 %). The relative risk of having obesity (compared to normal weight) was double in women (RRR = 2·04) compared with men. Participants who met the WHO recommendations for fruit and vegetable intake had 2·53 (95 % CI: 1·65-3·88) times greater risk of having obesity compared to those not meeting them. Also, the relative risk of having obesity in people with hypertension is 69 % higher than in people without hypertension (RRR = 1·69). In conclusion, obesity is highly prevalent in SMI and associated with chronic disease. The complex relationship between diet and risk of obesity was also highlighted. People with SMI and obesity could benefit from screening for non-communicable diseases, better nutritional education, and context-appropriate lifestyle interventions.

Behavioral Activation for Comorbid Depression in People With Noncommunicable Disease in India: Protocol for a Randomized Controlled Feasibility Trial.

BACKGROUND: The increasing burden of depression and noncommunicable disease (NCD) is a global challenge, especially in low- and middle-income countries, considering the resource constraints and lack of trained human resources in these settings. Effective treatment of depression in people with NCDs has the potential to enhance both the mental and physical well-being of this population. It will also result in the effective use of the available health care resources. Brief psychological therapies, such as behavioral activation (BA), are effective for the treatment of depression. BA has not been adapted in the community health care services of India, and the feasibility of using BA as an intervention for depression in NCD and its effectiveness in these settings have not been systematically evaluated. OBJECTIVE: Our objective is to adapt BA for the Indian NCD context and test the acceptability, feasibility, and implementation of the adapted BA intervention (BEACON intervention package [BIP]). Additionally, we aim to test the feasibility of a randomized controlled trial evaluation of BIP for the treatment of depression compared with enhanced usual care. METHODS: Following well-established frameworks for intervention adaptation, we first adapted BA (to fit the linguistic, cultural, and resource context) for delivery in India. The intervention was also adapted for potential remote delivery by telephone. In a randomized controlled trial, we will be testing the acceptability, feasibility, and implementation of the adapted BA intervention (BIP). We shall also test if a randomized controlled feasibility trial can be delivered effectively and estimate important parameters (eg, recruitment and retention rates and completeness of follow-up) needed to design a future definitive trial. RESULTS: Following the receipt of approval from all the relevant agencies, the development of the BIP was started on November 28, 2020, and completed on August 18, 2021, and the quantitative data collection was started on August 23, 2021, and completed on December 10, 2021. Process evaluation (qualitative data) collection is ongoing. Both the qualitative and quantitative data analyses are ongoing. CONCLUSIONS: This study may offer insights that could help in closing the gap in the treatment of common mental illness, particularly in nations with limited resources, infrastructure, and systems such as India. To close this gap, BEACON tries to provide BA for depression in NCDs through qualified NCD (BA) counselors integrated within the state-run NCD clinics. The results of this study may aid in understanding whether BA as an intervention is acceptable for the population and how feasible it will be to deliver such interventions for depression in NCD in South Asian countries such as India. The BIP may also be used in the future by Indian community clinics as a brief intervention program. TRIAL REGISTRATION: Clinical Trials Registry of India CTRI/2020/05/025048; https://tinyurl.com/mpt33jv5. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/41127.

Correction: Addressing TB multimorbidity in policy and practice: An exploratory survey of TB providers in 27 high-TB burden countries.

[This corrects the article DOI: 10.1371/journal.pgph.0001205.].

Perspectives of health workers engaging in task shifting to deliver health care in low-and-middle-income countries: a qualitative evidence synthesis.

BACKGROUND: Low- and middle-income countries (LMICs) are experiencing growing demand for healthcare services yet face a persistent shortage in access to specialist health workers (SHWs). Task shifting is an approach used to address this gap in service provision. Specific healthcare tasks are shifted to other, larger cadres of non-specialist health workers (NSHWs), including lay health workers with SHWs potentially taking on supervisory roles. Previous studies demonstrate that task shifting is both clinically and economically effective, however the impact of task shifting on health workers (HWs) is not fully understood. OBJECTIVE: The aim of this synthesis is to generate new knowledge about what influences HWs perspectives of benefits and costs of engaging in task shifting. METHODS: A qualitative evidence synthesis (QES) of peer-reviewed literature using databases CINAHL, the Cochrane Database of Systematic Reviews, Psych INFO, MEDLINE, EMBASE, Epistimonikos, Web of Science (science and social science citation index), Scopus LILACS, the African Index Medicus and Google Scholar. Eligible studies were those that included qualitative data about HWs perspectives of task shifting in LMICs. Information from eligible studies was extracted into a Google Sheet, and the data gathered were analysed thematically. RESULTS: Fifty-four studies were included in the QES. Results were organised under three themes, 'the cultural environment in which task shifting is employed', 'access to resources for task shifting' and 'alignment with personal values and beliefs, self-efficacy and personal emotional resilience'. CONCLUSION: This is the first review bringing together views about task shifting from the perspective of different cadres of HWs drawn from diverse healthcare, geographical and country settings in LMICs. Task shifting is a complex process which relies upon the active engagement of HWs. Taking into consideration factors that influence HWs perspectives, such as their personal characteristics, preparatory training, and ongoing access to resources, is important for informing how task shifted healthcare initiatives are designed and delivered to successfully widen access to healthcare in LMICs.

Barriers and facilitators to integrating depression care in tuberculosis services in South Asia: a multi-country qualitative study.

BACKGROUND: Depression is common among people with tuberculosis (TB). The condition is typically unrecognised or untreated despite available and effective treatments in most low- and middle-income countries. TB services in these countries are relatively well established, offering a potential opportunity to deliver integrated depression screening and care. However, there is limited evidence on how such integration could be achieved. This study aimed to understand the barriers and facilitators to integrate depression care in TB services. METHODS: We conducted nine workshops with 76 study participants, including people with TB, their carers, and health service providers in Bangladesh, India, and Pakistan, seeking views on integrating depression care into TB clinics. We used a deductive thematic approach to analyse the translated transcripts of audio recordings, contemporaneous notes made during workshops for Bangladesh and India and workshop reports for Pakistan. Using the SURE (Supporting the Use of Research Evidence) thematic framework, we extracted and categorised barriers and facilitators into various domains. RESULTS: Reported barriers to integrating depression care in TB services included lack of knowledge about depression amongst patients and the staff, financial burden, and associated stigma for people with TB and their carers. Government buy-in and understanding of how to identify and screen for depression screening were potential facilitators reported. Additionally, breaking through mental health stigma and providing the additional resources required to deliver this service (human resources and consultation time) were essential for integrating depression and TB care. CONCLUSIONS: Depression is a common condition found among people with TB, requiring early identification among people with TB. Integrating depression care into Tb services by health workers requires the availability of political support and the provision of resources.

IMPACT smoking cessation support for people with severe mental illness in South Asia (IMPACT 4S): A protocol for a randomised controlled feasibility trial of a combined behavioural and pharmacological support intervention.

INTRODUCTION: The prevalence of smoking is high among people living with severe mental illness (SMI). Evidence on feasibility, acceptability and effectiveness of smoking cessation interventions among smokers with SMI is lacking, particularly in low- and middle-income countries. We aim to test the feasibility and acceptability of delivering an evidence-based intervention,i.e., the IMPACT smoking cessation support for people with severe mental illness in South Asia (IMPACT 4S) intervention that is a combination of behavioural support and smoking cessation pharmacotherapies among adult smokers with SMI in India and Pakistan. We will also test the feasibility and acceptability of evaluating the intervention in a randomised controlled trial. METHODS: We will conduct a parallel, open label, randomised controlled feasibility trial among 172 (86 in each country) adult smokers with SMI in India and Pakistan. Participants will be allocated 1:1 to either Brief Advice (BA) or the IMPACT 4S intervention. BA comprises a single five-minute BA session on stopping smoking. The IMPACT 4S intervention comprises behavioural support delivered in upto 15 one-to-one, face-to-face or audio/video, counselling sessions, with each session lasting between 15 and 40 minutes; nicotine gum and/or bupropion; and breath carbon monoxide monitoring and feedback. Outcomes are recruitment rates, reasons for ineligibility/non-participation/non-consent of participants, length of time required to achieve required sample size, retention in study and treatments, intervention fidelity during delivery, smoking cessation pharmacotherapy adherence and data completeness. We will also conduct a process evaluation. RESULTS: Study will address- uncertainty about feasibility and acceptability of delivering smoking cessation interventions, and ability to conduct smoking cessation trials, among adult smokers with SMI in low- and middle-income countries. CONCLUSIONS: This is to inform further intervention adaptation, and the design and conduct of future randomised controlled trials on this topic. Results will be disseminated through peer-review articles, presentations at national, international conferences and policy-engagement forums. TRIAL REGISTRATION: ISRCTN34399445 (Updated 22/03/2021), ISRCTN Registry https://www.isrctn.com/.

A Core Outcome Set for Interventions to Prevent and/or Treat Delirium in Palliative Care.

CONTEXT: Delirium is a serious neurocognitive syndrome which is highly prevalent in people approaching the end of life. Existing trials of interventions to prevent or treat delirium in adults receiving palliative care report heterogeneous outcomes. OBJECTIVES: To undertake an international consensus process to develop a core outcome set for trials of interventions, designed to prevent and/or treat delirium, for adults receiving palliative care. METHODS: The core outcome set development process included a systematic review, qualitative interviews, modified Delphi method and virtual consensus meetings using nominal group technique (Registration http://www.comet-initiative.org/studies/details/796). Participants included family members, clinicians, and researchers with experience of delirium in palliative care. RESULTS: Forty outcomes were generated from the systematic review and interviews informing the Delphi Round one survey. The international Delphi panel comprised 92 participants including clinicians (n = 71, 77%), researchers (n = 13, 14%), and family members (n = 8, 9%). Delphi Round two was completed by 77 (84%) participants from Round one. Following the consensus meetings, four outcomes were selected for the core outcome set: 1) delirium occurrence (incidence and prevalence); 2) duration of delirium until resolution defined as either no further delirium in this episode of care or death; 3) overall delirium symptom profile (agitation, delusions or hallucinations, delirium symptoms and delirium severity); 4) distress due to delirium (person with delirium, and/or family and/or carers [including healthcare professionals]). CONCLUSION: Using a rigorous consensus process, we developed a core outcome set comprising four delirium-specific outcomes for inclusion in future trials of interventions to prevent and/or treat delirium in palliative care.