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.

Development of a Supported Self-management Intervention for People With Severe Mental Illness and Type 2 Diabetes: Theory and Evidence-Based Co-design Approach.

BACKGROUND: Type 2 diabetes is 2 to 3 times more common among people with severe mental illness (SMI). Self-management is crucial, with additional challenges faced by people with SMI. Therefore, it is essential that any diabetes self-management program for people with SMI addresses the unique needs of people living with both conditions and the inequalities they experience within health care services. OBJECTIVE: We combined theory, empirical evidence, and co-design approaches to develop a type 2 diabetes self-management intervention for people with SMI. METHODS: The development process encompassed 4 steps: step 1 involved prioritizing the mechanisms of action (MoAs) and behavior change techniques (BCTs) for the intervention. Using findings from primary qualitative research and systematic reviews, we selected candidate MoAs to target in the intervention and candidate BCTs to use. Expert stakeholders then ranked these MoAs and BCTs using a 2-phase survey. The average scores were used to generate a prioritized list of MoAs and BCTs. During step 2, we presented the survey results to an expert consensus workshop to seek expert agreement with the definitive list of MoAs and BCTs for the intervention and identify potential modes of delivery. Step 3 involved the development of trigger films using the evidence from steps 1 and 2. We used animations to present the experiences of people with SMI managing diabetes. These films were used in step 4, where we used a stakeholder co-design approach. This involved a series of structured workshops, where the co-design activities were informed by theory and evidence. RESULTS: Upon the completion of the 4-step process, we developed the DIAMONDS (diabetes and mental illness, improving outcomes and self-management) intervention. It is a tailored self-management intervention based on the synthesis of the outputs from the co-design process. The intervention incorporates a digital app, a paper-based workbook, and one-to-one coaching designed to meet the needs of people with SMI and coexisting type 2 diabetes. CONCLUSIONS: The intervention development work was underpinned by the MoA theoretical framework and incorporated systematic reviews, primary qualitative research, expert stakeholder surveys, and evidence generated during co-design workshops. The intervention will now be tested for feasibility before undergoing a definitive evaluation in a pragmatic randomized controlled trial.

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.

Developing a core outcome set for hospital deprescribing trials for older people under the care of a geriatrician.

BACKGROUND: Half of older people are prescribed unnecessary/inappropriate medications that are not routinely deprescribed in hospital hence there is a need for deprescribing trials. We aimed to develop a Core Outcome Set (COS) for deprescribing trials for older people under the care of a geriatrician during hospital admission. METHODS: We developed a list of potentially relevant outcomes from the literature. Using a two-round Delphi survey of stakeholder groups representing older people and carers, hospital clinicians, hospital managers, and ageing/deprescribing researchers, each outcome was scored according to Grading of Recommendations Assessment, Development and Evaluation, followed by two consensus workshops to finalise the COS. RESULTS: Two hundred people completed Round 1 and 114 completed Round 2. Representing all stakeholder groups, 10 people participated in workshop 1 and 10 in workshop 2. Six outcomes were identified as most important, feasible and acceptable to collect in a trial: number of prescribed medicines stopped; number of prescribed medicines with dosage reduced; quality of life; mortality; adverse drug events and number of hospital stays. Three other outcomes were identified as important, but currently too burdensome to collect: number of potentially inappropriate medicines prescribed; burden from medication routine; and medication-related admissions to hospital. CONCLUSIONS: A COS represents the minimum outcomes that should be collected and reported. Whilst uncommon practice for COS development, the value of considering outcome collection feasibility is demonstrated by the removal of three potential outcomes that, if included, may have compromised COS uptake due to challenges with collecting the data.

Experiences of patients with heart failure with medicines at transition intervention: Findings from the process evaluation of the Improving the Safety and Continuity of Medicines management at Transitions of care (ISCOMAT) programme.

BACKGROUND: Medicines are often suboptimally managed for heart failure patients across the transition from hospital to home, potentially leading to poor patient outcomes. The Improving the Safety and Continuity Of Medicines management at Transitions of care programme included: understanding the problems faced by patients and healthcare professionals; developing and co-designing the Medicines at Transitions of care Intervention (MaTI); a cluster randomized controlled trial testing the effectiveness of a complex behavioural MaTI aimed at improving medicines management at the interface between hospitals discharge and community care for patients with heart failure; and a process evaluation. The MaTI included a patient-held My Medicines Toolkit; enhanced communication between the hospital and the patient's community pharmacist and increased engagement of the community pharmacist postdischarge. This paper reports on the patients' experiences of the MaTI and its implementation from the process evaluation. DESIGN: Twenty one-to-one semi-structured patient interviews from six intervention sites were conducted between November 2018 and January 2020. Data were analysed using the Framework method, involving patients as co-analysts. Interview data were triangulated with routine trial data, the Consolidated Framework for Implementation Research and a logic model. RESULTS: Within the hospital setting patients engaged with the toolkit according to whether staff raised awareness of the My Medicines Toolkit's importance and the time and place of its introduction. Patients' engagement with community pharmacy depended on their awareness of the community pharmacist's role, support sources and perceptions of involvement in medicines management. The toolkit's impact on patients' medicines management at home included reassurance during gaps in care, increased knowledge of medicines, enhanced ability to monitor health and seek support and supporting sharing medicines management between formal and informal care networks. CONCLUSION: Many patients perceived that the MaTI offered them support in their medicines management when transitioning from hospital into the community. Importantly, it can be incorporated into and built upon patients' lived experiences of heart failure. Key to its successful implementation is the quality of engagement of healthcare professionals in introducing the intervention. PATIENT OR PUBLIC CONTRIBUTION: Patients were involved in the study design, as qualitative data co-analysts and as co-authors.

"Everything the hujur tells is very educative but if I cannot apply those in my own life then there is no meaning": a mixed-methods process evaluation of a smoke-free homes intervention in Bangladesh.

BACKGROUND: Second-hand smoke exposure from tobacco significantly contributes to morbidity and mortality worldwide. A cluster RCT in Bangladesh compared a community-based smoke-free home (SFH) intervention delivered in mosques, with or without indoor air quality (IAQ) feedback to households to no intervention. Neither was effective nor cost-effective compared to no intervention using an objective measure of second-hand smoke. This paper presents the process evaluation embedded within the trial and seeks to understand this. METHODS: A mixed method process evaluation comprising interviews with 30 household leads and six imams (prayer leader in mosque), brief questionnaire completed by 900 household leads (75% response), fidelity assessment of intervention delivery in six (20%) mosques and research team records. Data were triangulated using meta-themes informed by three process evaluation functions: implementation, mechanisms of impact and context. RESULTS: IMPLEMENTATION: Frequency of SFH intervention delivery was judged moderate to good. However there were mixed levels of intervention fidelity and poor reach. Linked Ayahs (verses of the Qur'an) with health messages targeting SHS attitudes were most often fully implemented and had greatest reach (along with those targeting social norms). Frequency and reach of the IAQ feedback were good. MECHANISMS OF IMPACT: Both interventions had good acceptability. However, views on usefulness of the interventions in creating a SFH were mixed. Individual drivers to behaviour change were new SFH knowledge with corresponding positive attitudes, social norms and intentions. Individual barriers were a lack of self-efficacy and plans. CONTEXT: Social context drivers to SFH intervention implementation in mosques were in place and important. No context barriers to implementation were reported. Social context drivers to SHS behaviour change were children's requests. Barriers were women's reluctance to ask men to smoke outside alongside general reluctance to request this of visitors. (Not) having somewhere to smoke outside was a physical context (barrier) and driver. CONCLUSIONS: Despite detailed development and adaption work with relevant stakeholders, the SFH intervention and IAQ feedback became educational interventions that were motivational but insufficient to overcome significant context barriers to reduce objectively measured SHS exposure in the home. Future interventions could usefully incorporate practical support for SFH behaviour change. Moreover, embedding these into community wide strategies that include practical cessation support and enforcement of SFH legislation is needed. TRIAL REGISTRATION: Current Controlled Trials ISRCTN49975452.

Acceptability of the Brushing RemInder 4 Good oral HealTh (BRIGHT) trial intervention: a qualitative study of perspectives of young people and school staff.

BACKGROUND: The Brushing RemInder 4 Good oral HealTh (BRIGHT) trial is investigating the clinical and cost-effectiveness of a multi-component behaviour change intervention to reduce the prevalence of dental caries in young people from deprived areas aged 11-13 years. Mobile health has gained popularity in delivering behaviour change interventions for improving oral health. The intervention, based on behaviour change theory, consists of two components; a single classroom-based session embedded in the school curriculum and a series of follow-up text messages (SMS) delivered twice daily to participants. This element of the process evaluation aimed to explore the acceptability of the BRIGHT intervention for pupils and school staff. METHODS: Qualitative study, based on the concept of acceptability. Focus groups were conducted with 50 pupils, from six secondary schools across the UK, who had received the intervention. Semi-structured interviews were conducted with 12 members of staff. Purposive maximum variation sampling was used. Interviews were transcribed verbatim and analysed using a framework approach. RESULTS: In line with the theoretical framework of acceptability, affective attitude, perceived effectiveness, ethicality, burden and self-efficacy were identified as factors that affect the acceptability of the BRIGHT intervention. Pupil participants appreciated learning about the consequences of inadequate brushing particularly the photographs of carious teeth during the classroom-based session. More detailed information on brushing techniques and follow-up lessons on oral health were recommended by pupils. In terms of the SMS, the data suggest that pupil participants found them to be helpful reminders for brushing their teeth. To further improve acceptability, more choice over the timing of the messages and greater interactivity to reduce tedium were suggested. Staff participants recognised the value of the lesson and reported that in general the content was suitable for their pupils. Having the lesson material prepared for them, having the necessary support and whether it was included in the curriculum, were factors that improved acceptability. CONCLUSION: Overall, pupils and staff found the BRIGHT intervention acceptable and made some suggestions which could be adopted in any subsequent implementation of the intervention.

Smokeless Tobacco Initiation, Use, and Cessation in South Asia: A Qualitative Assessment.

INTRODUCTION: Smokeless tobacco (ST) is a significant South Asian public health problem. This paper reports a qualitative study of a sample of South Asian ST users. METHODS: Interviews, using a piloted topic guide, with 33 consenting, urban dwelling adult ST users explored their ST initiation, continued use, and cessation attempts. Framework data analysis was used to analyze country specific data before a thematic cross-country synthesis was completed. RESULTS: Participants reported long-term ST use and high dependency. All reported strong cessation motivation and multiple failed attempts because of ease of purchasing ST, tobacco dependency, and lack of institutional support. CONCLUSIONS: Interventions to support cessation attempts among consumers of South Asian ST products should address the multiple challenges of developing an integrated ST policy, including cessation services. IMPLICATIONS: This study provides detailed understanding of the barriers and drivers to ST initiation, use, and cessation for users in Bangladesh, India, and Pakistan. It is the first study to directly compare these three countries. The insight was then used to adapt an existing behavioral support intervention for ST cessation for testing in these countries.

Development of a secondary school-based digital behaviour change intervention to improve tooth brushing.

BACKGROUND: Dental caries in adolescents remains a significant public health problem with few oral health promotion interventions aimed at reducing dental caries in secondary school-aged students. Previous oral health and mobile health (mHealth) research has suggested the need for the development of a school-based behaviour change intervention incorporating a digital component. This study aimed to describe the development process of a behaviour change intervention to improve the oral health of students aged 11-16 years attending secondary schools in the UK. METHODS: A six-step process was used to develop the complex intervention informed by behaviour change theory and involving students, young people, parents and teachers in the process. The steps were: (1) identifying the target behaviours, namely tooth brushing with a fluoride toothpaste (2) identifying the theoretical basis and developing the causal model (3) reviewing the relevant literature and developing the logic model (4) designing the intervention with young people, parents and school staff (5) specifying the intervention content and (6) translating this content into features of the intervention and piloting. RESULTS: The resultant intervention included a quality-assured classroom-based session (CBS) (guided by a lesson plan and teaching resources), delivered by school teachers which was embedded within the school curriculum. This CBS was followed by a series of (Short Message Service) SMS texts delivered twice daily to student's mobile telephones with the content, duration and timing of the messages informed by involvement of students and young people. CONCLUSIONS: An intervention to improve the oral health of secondary school students through improved tooth brushing was rigorously developed based on behaviour change theory and work with young people, parents and school staff. Further research is needed to evaluate the outcomes and processes involved following the delivery of this intervention. BRIGHT Trial Trial Registration ISRCTN12139369.

The effect of short-term exposure to the natural environment on depressive mood: A systematic review and meta-analysis.

BACKGROUND: Research suggests that exposure to the natural environment can improve mood, however, current reviews are limited in scope and there is little understanding of moderators. OBJECTIVE: To conduct a comprehensive systematic review and meta-analysis of the evidence for the effect of short-term exposure to the natural environment on depressive mood. METHODS: Five databases were systematically searched for relevant studies published up to March 2018. Risk of bias was evaluated using the Cochrane Risk of Bias (ROB) tool 1.0 and the Risk of Bias in Non-Randomised Studies of Interventions (ROBINS-I) tool where appropriate. The Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) approach was used to assess the quality of evidence overall. A random-effects meta-analysis was performed. 20 potential moderators of the effect size were coded and the machine learning-based MetaForest algorithm was used to identify relevant moderators. These were then entered into a meta-regression. RESULTS: 33 studies met the inclusion criteria. Effect sizes ranged from -2.30 to 0.84, with an unweighted mean effect size of Mg=-0.29,SD=0.60. However, there was significant residual heterogeneity between studies and risk of bias was high. Type of natural environment, type of built environment, gender mix of the sample, and region of study origin, among others, were identified as relevant moderators but were not significant when entered in a meta-regression. The quality of evidence was rated very low to low. An assessment of publication bias was inconclusive. CONCLUSIONS: A small effect was found for reduction in depressive mood following exposure to the natural environment. However, the high risk of bias and low quality of studies limits confidence in the results. The variation in effect size also remains largely unexplained. It is recommended that future studies make use of reporting guidelines and aim to reduce the potential for bias where possible.

Electronic Systems for Patients to Report and Manage Side Effects of Cancer Treatment: Systematic Review.

BACKGROUND: There has been a dramatic increase in the development of electronic systems to support cancer patients to report and manage side effects of treatment from home. Systems vary in the features they offer to patients, which may affect how patients engage with them and how they improve patient-centered outcomes. OBJECTIVE: This review aimed to (1) describe the features and functions of existing electronic symptom reporting systems (eg, symptom monitoring, tailored self-management advice), and (2) explore which features may be associated with patient engagement and patient-centered outcomes. METHODS: The review was registered with the International Prospective Register of Systematic Reviews (PROSPERO) and followed guidelines from the Centre for Reviews and Dissemination (University of York, United Kingdom). Primary searches were undertaken of MEDLINE, Embase, PsycInfo, Web of Science, Cochrane Central Register of Controlled Trials, and the Health Technology Assessment databases. Secondary searches were undertaken by screening reference lists and citations. Two researchers applied broad inclusion criteria to identify and select relevant records. Data were extracted and summarized using Microsoft Excel. In order to meet the aims, the study selection, data extraction, and data synthesis comprised two stages: (1) identifying and characterizing available systems and (2) summarizing data on patient engagement and patient-centered outcomes. RESULTS: We identified 77 publications relating to 41 distinct systems. In Stage 1, all publications were included (N=77). The features identified that supported clinicians and care were facility for health professionals to remotely access and monitor patient-reported data (24/41, 58%) and function to send alerts to health professionals for severe symptoms (17/41, 41%). Features that supported patients were facility for patients to monitor/review their symptom reports over time (eg, graphs) (19/41, 46%), general patient information about cancer treatment and side effects (17/41, 41%), tailored automated patient advice on symptom management (12/41, 29%), feature for patients to communicate with the health care team (6/41, 15%), and a forum for patients to communicate with one another (4/41, 10%). In Stage 2, only publications that included some data on patient engagement or patient-centered outcomes were included (N=29). A lack of consistency between studies in how engagement was defined, measured, or reported, and a wide range of methods chosen to evaluate systems meant that it was not possible to compare across studies or make conclusions on relationships with system features. CONCLUSIONS: Electronic systems have the potential to help patients manage side effects of cancer treatment, with some evidence to suggest a positive effect on patient-centered outcomes. However, comparison across studies is difficult due to the wide range of assessment tools used. There is a need to develop guidelines for assessing and reporting engagement with systems, and a set of core outcomes for evaluation. We hope that this review will contribute to the field by introducing a taxonomy for characterizing system features. TRIAL REGISTRATION: PROSPERO CRD42016035915; www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42016035915.

Which Behavior Change Techniques May Help Waterpipe Smokers to Quit? An Expert Consensus Using a Modified Delphi Technique.

Introduction: Waterpipe smoking is addictive and harmful. The determinants of waterpipe smoking may differ from those of cigarette smoking; therefore, behavioral approaches to support quitting may also differ between these two tobacco products. While some evidence exists on effective behavioral change techniques (BCTs) to facilitate cigarette smoking cessation, there is little research on waterpipe smoking cessation. Methods: Twenty-four experts were selected from the author lists of peer-reviewed, randomized controlled trials on waterpipe smoking cessation. They were invited to two rounds of a consensus development exercise using modified Delphi technique. Experts ranked 55 BCTs categorized further into those that promote; "awareness of harms of waterpipe smoking and advantages of quitting" (14), "preparation and planning to quit" (29), and "relapse prevention and sustaining an ex-smoker identity" (12) on their potential effectiveness. Kendall's W statistics was used to assess agreement. Results: Fifteen experts responded in round 1 and 14 completed both rounds. A strong consensus was achieved for BCTs that help in "relapse prevention and sustaining ex-smoker identity" (w = 0.7; p < .001) and a moderate for those that promote "awareness of harms of waterpipe smoking and advantages of quitting" (w = 0.6; p < .001) and "preparation and planning to quit" (w = 0.6; p < .001). Providing information on the consequences of waterpipe smoking and its cessation, assessing readiness and ability to quit, and making people aware of the withdrawal symptoms, were the three highest-ranking BCTs. Conclusion: Based on expert consensus, an inventory of BCTs ordered for their potential effectiveness can be useful for health professionals offering cessation support to waterpipe smokers. Implications: Waterpipe smoking is addictive, harmful, and gaining global popularity, particularly among youth. An expert consensus on behavior change techniques, likely to be effective in supporting waterpipe smokers to quit, has practice and research implications. Smoking cessation advisors can use these techniques to counsel waterpipe smokers who wish to quit. Behavioral and public health scientists can also use these to develop and evaluate behavioral support interventions for this client group.

Behaviour change intervention for smokeless tobacco cessation: its development, feasibility and fidelity testing in Pakistan and in the UK.

BACKGROUND: People of South Asian-origin are responsible for more than three-quarters of all the smokeless tobacco (SLT) consumption worldwide; yet there is little evidence on the effect of SLT cessation interventions in this population. South Asians use highly addictive and hazardous SLT products that have a strong socio-cultural dimension. We designed a bespoke behaviour change intervention (BCI) to support South Asians in quitting SLT and then evaluated its feasibility in Pakistan and in the UK. METHODS: We conducted two literature reviews to identify determinants of SLT use among South Asians and behaviour change techniques (BCTs) likely to modify these, respectively. Iterative consensus development workshops helped in selecting potent BCTs for BCI and designing activities and materials to deliver these. We piloted the BCI in 32 SLT users. All BCI sessions were audiotaped and analysed for adherence to intervention content and the quality of interaction (fidelity index). In-depth interviews with16 participants and five advisors assessed acceptability and feasibility of delivering the BCI, respectively. Quit success was assessed at 6 months by saliva/urine cotinine. RESULTS: The BCI included 23 activities and an interactive pictorial resource that supported these. Activities included raising awareness of the harms of SLT use and benefits of quitting, boosting clients' motivation and self-efficacy, and developing strategies to manage their triggers, withdrawal symptoms, and relapse should that occur. Betel quid and Guthka were the common forms of SLT used. Pakistani clients were more SLT dependent than those in the UK. Out of 32, four participants had undetectable cotinine at 6 months. Fidelity scores for each site varied between 11.2 and 42.6 for adherence to content - maximum score achievable 44; and between 1.4 and 14 for the quality of interaction - maximum score achievable was 14. Interviews with advisors highlighted the need for additional training on BCTs, integrating nicotine replacement and reducing duration of the pre-quit session. Clients were receptive to health messages but most reported SLT reduction rather than complete cessation. CONCLUSION: We developed a theory-based BCI that was also acceptable and feasible to deliver with moderate fidelity scores. It now needs to be evaluated in an effectiveness trial.

A Web-Based and Mobile Health Social Support Intervention to Promote Adherence to Inhaled Asthma Medications: Randomized Controlled Trial.

BACKGROUND: Online communities hold great potential as interventions for health, particularly for the management of chronic illness. The social support that online communities can provide has been associated with positive treatment outcomes, including medication adherence. There are few studies that have attempted to assess whether membership of an online community improves health outcomes using rigorous designs. OBJECTIVE: Our objective was to conduct a rigorous proof-of-concept randomized controlled trial of an online community intervention for improving adherence to asthma medicine. METHODS: This 9-week intervention included a sample of asthmatic adults from the United Kingdom who were prescribed an inhaled corticosteroid preventer. Participants were recruited via email and randomized to either an "online community" or "no online community" (diary) condition. After each instance of preventer use, participants (N=216) were required to report the number of doses of medication taken in a short post. Those randomized to the online community condition (n=99) could read the posts of other community members, reply, and create their own posts. Participants randomized to the no online community condition (n=117) also posted their medication use, but could not read others' posts. The main outcome measures were self-reported medication adherence at baseline and follow-up (9 weeks postbaseline) and an objective measure of adherence to the intervention (visits to site). RESULTS: In all, 103 participants completed the study (intervention: 37.8%, 39/99; control: 62.2%, 64/117). MANCOVA of self-reported adherence to asthma preventer medicine at follow-up was not significantly different between conditions in either intention-to-treat (P=.92) or per-protocol (P=.68) analysis. Site use was generally higher in the control compared to intervention conditions. CONCLUSIONS: Joining an online community did not improve adherence to preventer medication for asthma patients. Without the encouragement of greater community support or more components to sustain engagement over time, the current findings do not support the use of an online community to improve adherence. CLINICALTRIAL: International Standard Randomized Controlled Trial Number (ISRCTN): 29399269; http://www.isrctn.com/ISRCTN29399269/29399269 (Archived by WebCite at http://www.webcitation.org/6fUbEuVoT).

Does electronic monitoring influence adherence to medication? Randomized controlled trial of measurement reactivity.

BACKGROUND: Electronic monitoring is recommended for accurate measurement of medication adherence but a possible limitation is that it may influence adherence. PURPOSE: To test the reactive effect of electronic monitoring in a randomized controlled trial. METHODS: A total of 226 adults with type 2 diabetes and HbA1c ≥58 mmol/mol were randomized to receiving their main oral glucose lowering medication in electronic containers or standard packaging. The primary outcomes were self-reported adherence measured with the MARS (Medication Adherence Report Scale; range 5-25) and HbA1c at 8 weeks. RESULTS: Non-significantly higher adherence and lower HbA1c were observed in the electronic container group (differences in means, adjusting for baseline value: MARS, 0.4 [95 % CI -0.1 to 0.8, p = 0.11]; HbA1c (mmol/mol), -1.02 [-2.73 to 0.71, p = 0.25]). CONCLUSIONS: Electronic containers may lead to a small increase in adherence but this potential limitation is outweighed by their advantages. Our findings support electronic monitoring as the method of choice in research on medication adherence. (Trial registration Current Controlled Trials ISRCT N30522359).

Documentary analysis of national and international guidance for community clinicians referring patients with suspected chronic limb-threatening ischaemia.

BACKGROUND: Delayed referral of patients with chronic limb-threatening ischaemia (CLTI) from the community to vascular services may increase risk of amputation due to delayed revascularisation. Lack of appropriate guidance for clinicians in the community may contribute to this problem. This documentary analysis investigated referral guidance available to primary care clinicians. METHODS: National and international documents providing guidance on CLTI management were identified by searching sources including Medline, Embase, Guidelines International Network and College/Society websites. Data were extracted on referral recommendations, target audience and author groups. Recommendations were coded according to the Behaviour Change Technique Taxonomy. Clinical practice guideline quality and ease of implementation were assessed independently by two reviewers using the Appraisal of Guidelines Research and Evaluation (AGREE) II and Guideline Implementability Appraisal (GLIA) tools, respectively. RESULTS: 12 documents containing guidance on CLTI referrals were included. Five were clinical practice guidelines. Nine targeted clinicians in the community among their audience, yet only one included a primary care clinician in their author group. Recommendations on identification and referral of CLTI were often in non-specific language and frequently assumed specialist knowledge of vascular disease. Just 4 of the 93 behaviour change techniques were identified in the guidance documents. Three relevant domains of the AGREE II tool were scored for five clinical practice guidelines: stakeholder involvement (range 21.4%-52.4%, mean 42.9%), clarity of presentation (range 71.4%-92.9%, mean 82.9%) and applicability (25.0%-57.1%, mean 36.8%). The GLIA tool identified barriers to ease of implementation for all five clinical practice guidelines. CONCLUSIONS: Most guidance for clinicians in the community on the management of CLTI has been written without their input and assumes knowledge of vascular disease, which may be lacking. Future guidance development should involve community clinicians, consider using additional behaviour change techniques, and improve the applicability and ease of implementation of recommendations.

Understanding delays in chronic limb-threatening ischaemia care: Application of the theoretical domains framework to identify factors affecting primary care clinicians' referral behaviours.

INTRODUCTION: Patients in the community with suspected Chronic limb-threatening ischaemia (CLTI) should be urgently referred to vascular services for investigation and management. The Theoretical Domains Framework (TDF) allows identification of influences on health professional behaviour in order to inform future interventions. Here, the TDF is used to explore primary care clinicians' behaviours with regards to recognition and referral of CLTI. METHODS: Semi-structured interviews were conducted with 20 podiatrists, nurses and general practitioners in primary care. Directed content analysis was performed according to the framework method. Utterances were coded to TDF domains, and belief statements were defined by grouping similar utterances. Relevance of domains was confirmed according to belief frequency, presence of conflicting beliefs and the content of the beliefs indicating relevance. RESULTS: Nine TDF domains were identified as relevant to primary care clinicians: Knowledge, Environmental context and resources, Memory, Decision and attention processes, Beliefs about capabilities, Skills, Emotions, Reinforcement and Behavioural regulation. Relationships across domains were identified, including how primary care clinician confidence and working in a highly pressurized environment can affect behaviour. CONCLUSION: We have identified key barriers and enablers to timely recognition and referral behaviour. These beliefs identify targets for theory-driven behaviour change interventions to reduce delays in CLTI pathways.

The symptom to assessment pathway for suspected chronic limb-threatening ischaemia (CLTI) affects quality of care: a process mapping exercise.

BACKGROUND: Delays in the pathway from first symptom to treatment of chronic limb-threatening ischaemia (CLTI) are associated with worse mortality and limb loss outcomes. This study examined the processes used by vascular services to provide urgent care to patients with suspected CLTI referred from the community. METHODS: Vascular surgery units from various regions in England were invited to participate in a process mapping exercise. Clinical and non-clinical staff at participating units were interviewed, and process maps were created that captured key staff and structures used to create processes for referral receipt, triage and assessment at the units. RESULTS: Twelve vascular units participated, and process maps were created after interviews with 45 participants. The units offered multiple points of access for urgent referrals from general practitioners and other community clinicians. Triage processes were varied, with units using different mixes of staff (including medical staff, podiatrists and s) and this led to processes of varying speed. The organisation of clinics to provide slots for 'urgent' patients was also varied, with some adopting hot clinics, while others used dedicated slots in routine clinics. Service organisation could be further complicated by separate processes for patients with and without diabetes, and because of the organisation of services regionally into vascular networks that had arterial and non-arterial centres. CONCLUSIONS: For referred patients with symptoms of CLTI, the points of access, triage and assessment processes used by vascular units are diverse. This reflects the local context and ingenuity of vascular units but can lead to complex processes. It is likely that benefits might be gained from simplification.

Qualitative study exploring the design of a patient-reported symptom-based risk stratification system for suspected head and neck cancer referrals: protocol for work packages 1 and 2 within the EVEREST-HN programme.

INTRODUCTION: Between 2009/2010 and 2019/2020, England witnessed an increase in suspected head and neck cancer (sHNC) referrals from 140 to 404 patients per 100 000 population. 1 in 10 patients are not seen within the 2-week target, contributing to patient anxiety. We will develop a pathway for sHNC referrals, based on the Head and Neck Cancer Risk Calculator. The evolution of a patient-reported symptom-based risk stratification system to redesign the sHNC referral pathway (EVEREST-HN) Programme comprises six work packages (WPs). This protocol describes WP1 and WP2. WP1 will obtain an understanding of language to optimise the SYmptom iNput Clinical (SYNC) system patient-reported symptom questionnaire for sHNC referrals and outline requirements for the SYNC system. WP2 will codesign key elements of the SYNC system, including the SYNC Questionnaire, and accompanying behaviour change materials. METHODS AND ANALYSIS: WP1 will be conducted at three acute National Health Service (NHS) trusts with variation in service delivery models and ensuring a broad mixture of social, economic and cultural backgrounds of participants. Up to 150 patients with sHNC (n=50 per site) and 15 clinicians (n=5 per site) will be recruited. WP1 will use qualitative methods including interviews, observation and recordings of consultations. Rapid qualitative analysis and inductive thematic analysis will be used to analyse the data. WP2 will recruit lay patient representatives to participate in online focus groups (n=8 per focus group), think-aloud technique and experience-based codesign and will be analysed using qualitative and quantitative approaches. ETHICS AND DISSEMINATION: The committee for clinical research at The Royal Marsden, a research ethics committee and the Health Research Authority approved this protocol. All participants will give informed consent. Ethical issues of working with patients on an urgent cancer diagnostic pathway have been considered. Findings will be disseminated via journal publications, conference presentations and public engagement activities.

Cognitive therapy for depression in tuberculosis treatment: protocol for multicentre pragmatic parallel arm randomised control trial with an internal pilot.

INTRODUCTION AND OBJECTIVES: There is an unmet need to develop high-quality evidence addressing tuberculosis (TB)-related mental health comorbidity, particularly in the context of lower-middle-income countries. This study aims to examine the effectiveness and cost-effectiveness of cognitive behavioural therapy (CBT) versus enhanced treatment as usual (ETAU) in improving depressive symptoms in people with TB and comorbid depression, enhancing adherence with anti-TB treatment (ATT) and its implementation in the real-world setting of Pakistan. METHODS: We will conduct a pragmatic parallel arm randomised control trial with an internal pilot. A brief psychological intervention based on CBT has been developed using a combination of qualitative and ethnographic studies. The inbuilt pilot trial will have a sample size of 80, while we plan to recruit 560 (280 per arm) participants in the definitive trial. Participants who started on ATT within 1 month of diagnosis for pulmonary and extrapulmonary TB or multidrug resistant TB (MDR-TB) and meeting the criteria for depression on Patient Health Questionnaire-9 (PHQ-9) will be randomised with 1:1 allocation to receive six sessions of CBT (delivered by TB healthcare workers) or ETAU. Data on the feasibility outcomes of the pilot will be considered to proceed with the definitive trial. Participants will be assessed (by a blinded assessor) for the following main trial primary outcomes: (1) severity of depression using PHQ-9 scale (interviewer-administered questionnaire) at baseline, weeks 8, 24 and 32 postrandomisation and (2) ATT at baseline and week 24 at the end of ATT therapy. ETHICS AND DISSEMINATION: Ethical approval has been obtained from Keele University Research Ethics Committee (ref: 2023-0599-792), Khyber Medical University Ethical Review Board (ref: DIR/KMU-EB/CT/000990) and National Bioethics Committee Pakistan (ref: No.4-87/NBC-998/23/587). The results of this study will be reported in peer-reviewed journals and academic conferences and disseminated to stakeholders and policymakers. TRIAL REGISTRATION NUMBER: ISRCTN10761003.