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.

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.

Hospital clinicians' perceptions and experiences of care pathways for chronic limb-threatening ischaemia: a qualitative study.

BACKGROUND: Chronic limb-threatening ischaemia (CLTI) is a condition associated with significant risks of lower limb loss and mortality, which increase with delays in management. Guidance recommends urgent referral and assessment, but delays are evident at every stage of the CLTI patient pathway. This study uses qualitative methods to explore hospital clinicians' experiences and perceptions of the existing CLTI pathway. METHODS: A qualitative interview study was conducted. Semi-structured interviews were undertaken with 13 clinicians involved in the assessment of patients referred to hospital with suspected CLTI, identified via purposive sampling from English vascular surgery units. Clinicians included podiatrists, vascular specialist nurses and doctors. Reflexive thematic analysis was performed on the data from a critical realist position. RESULTS: The need for speed was the single overarching theme identified. Four linked underlying themes were also identified; 1. Vascular surgery as the poor relation (compared to cancer and other specialties), with a sub-theme of CLTI being a challenging diagnosis. 2. Some patients are more equal than others, with sub-themes of diabetes vs. non-diabetes, hub vs. spoke and frailty vs. non-frail. 3. Life in the National Health Service (NHS) is tough, with sub-themes of lack of resource and we're all under pressure. 4. Non-surgeons can help. CONCLUSIONS: The underlying themes generated from the rich interview data describe barriers to timely referral, assessment and management of CLTI, as well as the utility of non-surgical roles such as podiatrists and vascular specialist nurses as a potential solution for delays. The overarching theme of the need for speed highlights the meaning given to adverse consequences of delays in management of CLTI by clinicians involved in its assessment. Future improvement projects aimed at the CLTI pathway should take these findings into account.

Children Learning About Secondhand Smoke (CLASS III): a protocol for a cluster randomised controlled trial of a school-based smoke-free intervention in Bangladesh and Pakistan.

INTRODUCTION: Secondhand smoke (SHS) exposure is a major cause of premature death and disease, especially among children. Children in economically developing countries are particularly affected as smoke-free laws are typically only partially implemented and private homes and cars remain a key source of SHS exposure. Currently, firm conclusions cannot be drawn from the available evidence on the effectiveness of non-legislative interventions designed to protect children from SHS exposure. Following the success of two feasibility studies and a pilot trial, we plan to evaluate a school-based approach to protect children from SHS exposure in Bangladesh and Pakistan-countries with a strong commitment to smoke-free environments but with high levels of SHS exposure in children. We will conduct a two-arm cluster randomised controlled trial in Bangladesh and Pakistan to assess the effectiveness and cost effectiveness of a school-based smoke-free intervention (SFI) in reducing children's exposure to SHS and the frequency and severity of respiratory symptoms. METHODS AND ANALYSIS: We plan to recruit 68 randomly selected schools from two cities-Dhaka in Bangladesh and Karachi in Pakistan. From each school, we will recruit approximately 40 students in a year (9-12 years old) with a total of 2720 children. Half of the schools will be randomly allocated to the intervention arm receiving SFI and the other half will receive usual education. Salivary cotinine concentration-a highly sensitive and specific biomarker of SHS exposure-is the primary outcome, which will be measured at month 3 post-randomisation. Secondary outcomes will include frequency and severity of respiratory symptoms, healthcare contacts, school absenteeism, smoking uptake and quality of life. Embedded economic and process evaluations will also be conducted. ETHICS AND DISSEMINATION: The trial has received ethics approval from the Research Governance Committee at the University of York. Approvals have also been obtained from Bangladesh Medical Research Council and Pakistan Health Research Council. If SFI is found effective, we will use a variety of channels to share our findings with both academic and non-academic audiences. We will work with the education departments in Bangladesh and Pakistan and advocate for including SFI within the curriculum. TRIAL REGISTRATION NUMBER: ISRCTN28878365.

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/.

"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.

Behavioural support and nicotine replacement therapy for smokeless tobacco cessation: protocol for a pilot randomised-controlled multi-country trial.

BACKGROUND: Smokeless tobacco (ST) is consumed globally by more than 350 million people, with approximately 85% of all users based in South and Southeast Asia. In this region, ST products are cheap and easily accessible. Evidence-based interventions to people quit ST use are lacking. This study aims to test the feasibility of conducting a future definitive trial of ST cessation, using a culturally adapted behavioural intervention, and/or nicotine replacement therapy (NRT) in three South Asian countries. METHODS: We will conduct a factorial design, randomised-controlled pilot trial in Bangladesh, India and Pakistan. Daily ST users will be recruited from primary health care settings in Dhaka, Noida and Karachi. Participants will be individually randomised to receive intervention A (4 or 6 mg NRT chewing gum for 8-weeks), intervention B (BISCA: face-to-face behavioural support for ST cessation), a combination of interventions A and B or usual care (Very Brief Advice - VBA). The participants will provide demographic and ST use related data at baseline, and at 6, 12 and 26 weeks of follow-up. Salivary cotinine samples will be collected at baseline and 26 weeks. The analyses will undertake an assessment of the feasibility of recruitment, randomisation, data collection and participant retention, as well as the feasibility of intervention delivery. We will also identify potential cessation outcomes to inform the main trial, understand the implementation, context and mechanisms of impact through a process evaluation and, thirdly, establish health resource use and impact on the quality of life through health economic data. DISCUSSION: The widespread and continued use of ST products in South Asia is consistent with a high rate of associated diseases and negative impact on the quality of life. The identification of feasible, effective and cost-effective interventions for ST is necessary to inform national and regional efforts to reduce ST use at the population level. The findings of this pilot trial will inform the development of larger trials for ST cessation among South Asian users, with relevance to wider regions and populations having high rates of ST use. TRIAL REGISTRATION: ISRCTN identifier 65109397.

Identifying ways to improve diabetes management during cancer treatments (INDICATE): protocol for a qualitative interview study with patients and clinicians.

INTRODUCTION: A large and growing number of patients with cancer have comorbid diabetes. Cancer and its treatment can adversely impact glycaemic management and control, and there is accumulating evidence that suboptimal glycaemic control during cancer treatment is a contributory driver of worse cancer-related outcomes in patients with comorbid diabetes. Little research has sought to understand, from the perspective of patients and clinicians, how and why different aspects of cancer care and diabetes care can complicate or facilitate each other, which is key to informing interventions to improve diabetes management during cancer treatments. This study aims to identify and elucidate barriers and enablers to effective diabetes management and control during cancer treatments, and potential intervention targets and strategies to address and harness these, respectively. METHODS AND ANALYSIS: Qualitative interviews will be conducted with people with diabetes and comorbid cancer (n=30-40) and a range of clinicians (n=30-40) involved in caring for this patient group (eg, oncologists, diabetologists, specialist nurses, general practitioners). Semistructured interviews will examine participants' experiences of and perspectives on diabetes management and control during cancer treatments. Data will be analysed using framework analysis. Data collection and analysis will be informed by the Theoretical Domains Framework, and related Theory and Techniques Tool and Behaviour Change Wheel, to facilitate examination of a comprehensive range of barriers and enablers and support identification of pertinent and feasible intervention approaches. Study dates: January 2021-January 2023. ETHICS AND DISSEMINATION: The study has approval from National Health Service (NHS) West Midlands-Edgbaston Research Ethics Committee. Findings will be presented to lay, clinical, academic and NHS and charity service-provider audiences via dissemination of written summaries and presentations, and published in peer-reviewed journals. Findings will be used to inform development and implementation of clinical, health services and patient-management intervention strategies to optimise diabetes management and control during cancer treatments.

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.

Efficacy and cost-effectiveness of a community-based smoke-free-home intervention with or without indoor-air-quality feedback in Bangladesh (MCLASS II): a three-arm, cluster-randomised, controlled trial.

BACKGROUND: Exposure to second-hand smoke from tobacco is a major contributor to global morbidity and mortality. We aimed to evaluate the efficacy and cost-effectiveness of a community-based smoke-free-home intervention, with or without indoor-air-quality feedback, in reducing second-hand-smoke exposure in homes in Bangladesh. METHODS: We did a three-arm, cluster-randomised, controlled trial in Dhaka, Bangladesh, and randomly assigned (1:1:1) mosques and consenting households from their congregations to a smoke-free-home intervention plus indoor-air-quality feedback, smoke-free-home intervention only, or usual services. Households were eligible if they had at least one resident attending one of the participating mosques, at least one adult resident (age 18 years or older) who smoked cigarettes or other forms of smoked tobacco (eg, bidi, waterpipe) regularly (on at least 25 days per month), and at least one non-smoking resident of any age. The smoke-free-home intervention consisted of weekly health messages delivered within an Islamic discourse by religious leaders at mosques over 12 weeks. Indoor-air-quality feedback comprised providing households with feedback on their indoor air quality measured over 24 h. Households in the usual services group received no intervention. Masking of participants and mosque leaders was not possible. The primary outcome was the 24-h mean household airborne fine particulate matter (<2·5 microns in diameter [PM2·5]) concentration (a marker of second-hand smoke) at 12 months after randomisation. Cost-effectiveness was estimated using incremental cost-effectiveness ratios (ICERs). This trial is registered with ISRCTN, 49975452. FINDINGS: Between April 11 and Aug 2, 2018, we enrolled 1801 households from 45 mosques. 640 households (35·5%) were assigned to the smoke-free-home intervention plus indoor-air-quality feedback group, 560 (31·1%) to the smoke-free-home intervention only group, and 601 (33·4%) to the usual services group. At 12 months, the adjusted mean difference in household mean 24-h PM2·5 concentration was -1·0 µg/m3 (95% CI -12·8 to 10·9, p=0·88) for the smoke-free-home intervention plus indoor-air-quality feedback group versus the usual services group, 5·0 µg/m3 (-7·9 to 18·0, p=0·45) for the smoke-free-home intervention only group versus the usual services group, and -6·0 µg/m3 (-18·3 to 6·3, p=0·34) for the smoke-free-home intervention plus indoor-air-quality feedback group versus the smoke-free-home intervention only group. The ICER for the smoke-free-home intervention plus indoor-air-quality feedback versus usual services was US$653 per quality-adjusted life-year (QALY) gained, which was more than the upper limit of the Bangladesh willingness-to-pay threshold of $427 per QALY. INTERPRETATION: The smoke-free-home intervention, with or without indoor-air-quality feedback, was neither effective nor cost-effective in reducing household second-hand-smoke exposure compared with usual services. These interventions are therefore not recommended for Bangladesh. FUNDING: Medical Research Council UK. TRANSLATION: For the Bengali translation of the abstract see Supplementary Materials section.

Preoperative Interventions for Alcohol and Other Recreational Substance Use: A Systematic Review and Meta-Analysis.

Background: Preoperative alcohol and other recreational substance use (ORSU) may catalyze perioperative complications. Accordingly, interventions aiming to reduce preoperative substance use are warranted. Methods: Studies investigating interventions to reduce alcohol and/or ORSU in elective surgery patients were identified from: Cochrane Library; MEDLINE; PSYCINFO; EMBASE; and CINAHL. In both narrative summaries of results and random effects meta-analyses, effects of interventions on perioperative alcohol/ORSU, complications, mortality and length of stay were assessed. Primary Results: Nine studies (n = 903) were included. Seven used behavioral interventions only, two provided disulfiram in addition. Pooled analyses found small effects on alcohol use (d: 0.34; 0.05-0.64), though two trials using disulfiram (0.71; 0.36-1.07) were superior to two using behavioral interventions (0.45; -0.49-1.39). No significant pooled effects were found for perioperative complications, length of hospital stay or mortality in studies solely targeting alcohol/ORSU. Too few interventions targeting ORSU (n = 1) were located to form conclusions regarding their efficacy. Studies were generally at high risk-of-bias and heterogeneous. Conclusions: Preoperative interventions were beneficial in reducing substance use in some instances, but more high-quality studies targeting alcohol/ORSU specifically are needed. The literature to date does not suggest that such interventions can reduce postoperative morbidity, length of hospital stay or mortality. Limitations in the literature are outlined and recommendations for future studies are suggested.

Muslim Communities Learning About Second-hand Smoke in Bangladesh (MCLASS II): study protocol for a cluster randomised controlled trial of a community-based smoke-free homes intervention, with or without Indoor Air Quality feedback.

BACKGROUND: Second-hand smoke (SHS) is a serious health hazard costing 890,000 lives a year globally. Women and children in many economically developing countries are worst affected as smoke-free laws are only partially implemented and homes remain a major source of SHS exposure. There is limited evidence on interventions designed to reduce SHS exposure in homes, especially in community settings. Following a successful pilot, a community-based approach to promote smoke-free homes in Bangladesh, a country with a strong commitment to smoke-free environments but with high levels of SHS exposure, will be evaluated. The study aims to assess the effectiveness and cost-effectiveness of a community-based intervention, Muslims for better Health (M4bH), with or without Indoor Air Quality (IAQ) feedback, in reducing non-smokers' exposure to SHS in the home. METHODS/DESIGN: Based on behaviour-change theories, M4bH and IAQ feedback are designed to discourage people from smoking indoors. M4bH consists of a set of messages couched within mainstream Islamic discourse, delivered weekly by faith leaders (imams and khatibs) in mosques over 12 weeks (one message each week). The messages address key determinants of current smoking behaviours including lack of knowledge and misconceptions on specific harms associated with SHS exposure. IAQ feedback consists of personalised information on IAQ measured by a particulate matter (PM2.5) monitor within the home. Following adaptation of M4bH and IAQ feedback for the Bangladeshi context, a three-arm cluster randomised controlled trial will be conducted in Dhaka. Forty-five mosques and 1800 households, with at least one smoker and one non-smoker, will be recruited. Mosques will be randomised to: M4bH and IAQ feedback; M4bH alone; or usual services only. The primary outcome is 24-h mean household concentration of indoor fine particulate matter (PM2.5) at 12 months post randomisation. Secondary outcomes are 24-h mean household PM2.5 at 3 months post randomisation, frequency and severity of respiratory symptoms, health care service use and quality of life. A cost-effectiveness analysis and process evaluation will also be conducted. DISCUSSION: The MCLASS II trial will test the potential of a community-based intervention to reduce second-hand smoke exposure at home and improve lung health among non-smokers in Bangladesh and beyond. TRIAL REGISTRATION: ISRCTN, ISRCTN49975452 . Registered on 11 January 2018.

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.

How Can Smoking Cessation Be Induced Before Surgery? A Systematic Review and Meta-Analysis of Behavior Change Techniques and Other Intervention Characteristics.

Background: Smokers who continue to smoke up to the point of surgery are at increased risk of a range of complications during and following surgery. Objective: To identify whether behavioral and/or pharmacological interventions increase the likelihood that smokers quit prior to elective surgery and which intervention components are associated with larger effects. Design: Systematic review with meta-analysis. Data sources: MEDLINE, Embase, and Embase Classic, CINAHL, CENTRAL. Study selection: Studies testing the effect of smoking reduction interventions delivered at least 24 h before elective surgery were included. Study appraisal and synthesis: Potential studies were independently screened by two people. Data relating to study characteristics and risk of bias were extracted. The effects of the interventions on pre-operative smoking abstinence were estimated using random effects meta-analyses. The association between specific intervention components (behavior change techniques; mode; duration; number of sessions; interventionist) and smoking cessation effect sizes were estimated using meta-regressions. Results: Twenty-two studies comprising 2,992 smokers were included and 19 studies were meta-analyzed. Interventions increased the proportion of smokers who were abstinent or reduced smoking by surgery relative to control: g = 0.56, 95% CI 0.32-0.80, with rates nearly double in the intervention (46.2%) relative to the control (24.5%). Interventions that comprised more sessions, delivered face-to-face and by nurses, as well as specific behavior change techniques (providing information on consequence of smoking/cessation; providing information on withdrawal symptoms; goal setting; review of goals; regular monitoring by others; and giving options for additional or later support) were associated with larger effects. Conclusion: Rates of smoking can be halved prior to surgery and a number of intervention characteristics can increase these effects. There was, however, some indication of publication bias meaning the benefits of such interventions may be smaller than estimated. Registration: Prospero 2015: CRD42015024733.

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.

Self-Management and Self-Management Support Outcomes: A Systematic Review and Mixed Research Synthesis of Stakeholder Views.

INTRODUCTION: Self-management has received growing attention as an effective approach for long-term condition management. Little is known about which outcomes of supported self-management are valued by patients, their families, health professionals and those who commission self-management services. This study systematically reviewed published empirical evidence in accordance with PRISMA guidelines to determine the outcomes of self-management valued by these key stakeholder groups, using three prominent exemplar conditions: colorectal cancer, diabetes and stroke. AIM: To systematically review the literature to identify which generic outcomes of self-management have been targeted and are considered important using three exemplar conditions (colorectal cancer, diabetes and stroke), which collectively have a range of features that are likely to be representative of generic self-management issues. METHODS: Systematic searching of nine electronic databases was conducted in addition to hand searches of review articles. Abstracts were identified against inclusion criteria and appraised independently by two reviewers, using a critical appraisal tool. Synthesis of findings was conducted using mixed research synthesis. RESULTS: Over 20,536 abstracts were screened. 41 studies which met the review criteria were fully retrieved and appraised. The majority of evidence related to diabetes. Few studies directly focussed on stakeholders' views concerning desired self-management outcomes; the majority of evidence was derived from studies focusing upon the experience of self-management. The views of health care commissioners were absent from the literature. We identified that self-management outcomes embrace a range of indicators, from knowledge, skills, and bio-psychosocial markers of health through to positive social networks. CONCLUSIONS: Patients', families', health professionals' and commissioners' views regarding which outcomes of self-management are important have not been clearly elicited. The extent to which bio-psychosocial indicators relate to successful self-management from the perspectives of all groups of stakeholders is unknown. Further investigation regarding which self-management outcomes are considered important by all stakeholders is necessary to guide the commissioning and design of future self-management services.

Impact of informed-choice invitations on diabetes screening knowledge, attitude and intentions: an analogue study.

BACKGROUND: Despite concerns that facilitating informed choice would decrease diabetes screening uptake, 'informed choice' invitations that increased knowledge did not affect attendance (the DICISION trial). We explored possible reasons using data from an experimental analogue study undertaken to develop the invitations. We tested a model of the impact on knowledge, attitude and intentions of a diabetes screening invitation designed to facilitate informed choices. METHODS: 417 men and women aged 40-69 recruited from town centres in the UK were randomised to receive either an invitation for diabetes screening designed to facilitate informed choice or a standard type of invitation. Knowledge of the invitation, attitude towards diabetes screening, and intention to attend for diabetes screening were assessed two weeks later. RESULTS: Attitude was a strong predictor of screening intentions (ß = .64, p = .001). Knowledge added to the model but was a weak predictor of intentions (ß = .13, p = .005). However, invitation type did not predict attitudes towards screening but did predict knowledge (ß = -.45, p = .001), which mediated a small effect of invitation type on intention (indirect ß = -.06, p = .017). CONCLUSIONS: These findings may explain why information about the benefits and harms of screening did not reduce diabetes screening attendance in the DICISION trial.

Impact of an informed choice invitation on uptake of screening for diabetes in primary care (DICISION): trial protocol.

BACKGROUND: Screening invitations have traditionally been brief, providing information only about population benefits. Presenting information about the limited individual benefits and potential harms of screening to inform choice may reduce attendance, particularly in the more socially deprived. At the same time, amongst those who attend, it might increase motivation to change behavior to reduce risks. This trial assesses the impact on attendance and motivation to change behavior of an invitation that facilitates informed choices about participating in diabetes screening in general practice. Three hypotheses are tested: 1. Attendance at screening for diabetes is lower following an informed choice compared with a standard invitation. 2. There is an interaction between the type of invitation and social deprivation: attendance following an informed choice compared with a standard invitation is lower in those who are more rather than less socially deprived. 3. Amongst those who attend for screening, intentions to change behavior to reduce risks of complications in those subsequently diagnosed with diabetes are stronger following an informed choice invitation compared with a standard invitation. METHOD/DESIGN: 1500 people aged 40-69 years without known diabetes but at high risk are identified from four general practice registers in the east of England. 1200 participants are randomized by households to receive one of two invitations to attend for diabetes screening at their general practices. The intervention invitation is designed to facilitate informed choices, and comprises detailed information and a decision aid. A comparison invitation is based on those currently in use. Screening involves a finger-prick blood glucose test. The primary outcome is attendance for diabetes screening. The secondary outcome is intention to change health related behaviors in those attenders diagnosed with diabetes. A sample size of 1200 ensures 90% power to detect a 10% difference in attendance between arms, and in an estimated 780 attenders, 80% power to detect a 0.2 sd difference in intention between arms. DISCUSSION: The DICISION trial is a rigorous pragmatic denominator based clinical trial of an informed choice invitation to diabetes screening, which addresses some key limitations of previous trials.

Evaluation of an informed choice invitation for type 2 diabetes screening.

OBJECTIVE: To evaluate an innovative invitation designed to facilitate informed choices for undergoing screening for type 2 diabetes. METHODS: Four hundred and seventeen people aged 40-69 years (sex: F 53%/M 47%), without known diabetes, recruited from street locations. Participants were randomised to receive one of two hypothetical invitations for screening for type 2 diabetes; one based on General Medical Council guidelines and combined with a decisional balance sheet, the other a brief traditional invitation. Informed choice was assessed immediately after the invitation and 3 weeks later using measures of knowledge, attitudes and intentions. RESULTS: Two weeks after receipt of the invitation, the proportion of informed choices was significantly higher among participants who received the informed choice invitation compared with those who received the traditional invitation (42.9% versus 11.2%; difference=31.7%, 95% CI: 22.5-40.5%; p<0.001). Mean knowledge scores were significantly higher after the receipt of the invitation designed to facilitate informed choices than after the traditional invitation (5.49 versus 3.90; t(405)=10.106, p<0.001). Intentions to participate in screening were unaffected by receipt of the informed choice invitation. CONCLUSION: Compared with a traditional invitation, receipt of the invitation designed to facilitate informed choices increased the proportion of informed choices about type 2 diabetes screening attendance. PRACTICE IMPLICATIONS: : Although the new invitation was associated with better knowledge of screening it had no differential effect on intention and its effect on attendance still requires evaluation.