Patient and caregiver experiences of living with dementia in Tanzania.

Introduction: Tanzania is a low-income country with an increasing prevalence of dementia, which provides challenges for the existing healthcare system. People with dementia often don't receive a formal diagnosis, and with a lack of formal healthcare, are often predominantly supported by family relatives. There are very few published data relating to lived experiences of people with dementia in Tanzania. This study aimed to understand people with dementia, and their caregivers' experiences of living with dementia in Tanzania and the perceived needs of people with dementia.Methods: Qualitative, semi-structured interviews were conducted with 14 people with dementia and 12 caregivers in Moshi, Tanzania. Interviews were audio-recorded, translated, transcribed and analysed using a Framework Analysis approach.Results: Three sub-themes were identified within data describing the experience of 'Living with Dementia in Tanzania': 'Deteriorations in Health', 'Challenges to living with Dementia in Tanzanian Culture', and 'Lack of Support': people with dementia faced challenges due to social isolation, stigmatisation, and lack of caregiver knowledge on how best to provide support. Collectively, these impacted on both the physical and mental health of people with dementia. Misconceptions about dementia aetiology related to age, stresses of daily life and other co-morbidities. People with dementia were motivated to access treatment, exhibiting pluralistic health-seeking behaviours. There was an overall preference for non-pharmacological interventions over medication, with high levels of trust in medical professional opinions.Conclusions: Living with dementia in Tanzania is influenced by both cultural and religious factors. More work is needed to target supplementary healthcare (with efforts to promote accessibility), support for caregivers and public health education about dementia to overcome existent misconceptions and stigma.

Current practices in studies applying the target trial emulation framework: a protocol for a systematic review.

INTRODUCTION: Observational studies represent an alternative to estimate real-world causal effects in the absence of available randomised controlled trials (RCTs). Target trial emulation is a framework for the application of RCT design principles to emulate a hypothetical open-label RCT (the hypothetical target trial) using existing observational data as the primary data source as opposed to the prospective recruitment and measurement of randomised units. The aim of this systematic review is to investigate the practices of studies applying the target trial emulation framework to evaluate the effectiveness of interventions. METHODS AND ANALYSIS: We will systematically search in Medline (via Ovid), Embase (via Ovid, entries from medRxiv are included), PsycINFO (via Ovid), SCOPUS, Web of Science, Cochrane Library, the ISRCTN registry and ClinicalTrials.gov for all study reports and protocols which used the trial emulation framework (without time restriction). We will extract information concerning study design, data source, analysis, results, interpretation and dissemination. Two reviewers will perform study selection, data extraction and quality assessment. Disagreements between reviewers will be resolved by a third reviewer. A narrative approach will be used to synthesise and report qualitative and quantitative data. Reporting of the review will be informed by Preferred Reporting Items for Systematic Review and Meta-Analysis guidance (PRISMA). ETHICS AND DISSEMINATION: Ethical approval is not required as it is a protocol for a systematic review. Findings will be disseminated through peer-reviewed publications and conference presentations.

Parental perspectives on emergency health service use during the first wave of the COVID-19 pandemic in the United Kingdom: A qualitative study.

UK 'Lockdown' measures introduced in March 2020 aimed to mitigate the spread of COVID-19. Although seeking healthcare was still permitted within restrictions, paediatric emergency department attendances reduced dramatically and led to concern over risks caused by delayed presentation. Our aim was to gain insight into healthcare decisions faced by parents during the first wave of the COVID-19 pandemic and to understand if use of urgent healthcare, self-care, and information needs differed during lockdown as well as how parents perceived risks of COVID-19. We undertook qualitative telephone interviews with a purposive sample of parents living in the North East of England recruited through online advertising. We used a semi-structured interview schedule to explore past and current healthcare use, perceptions of risk and the impact of the pandemic on healthcare decisions. Interviews were transcribed and analysed using Thematic Analysis. Three major themes were identified which concerned (i) how parents made sense of risks posed to, and by their children, (ii) understanding information regarding health services and (iii) attempting to make the right decision. These themes contribute to the understanding of the initial impact of COVID-19 and associated restrictions on parental decisions about urgent healthcare for children. These findings are important to consider when planning for potential future public health emergencies but also in the wider context of encouraging appropriate use of urgent healthcare.

The financial and quality of life impact of urgent dental presentations: A cross-sectional study.

AIM: This study aimed to: (i) calculate personal financial costs associated with urgent dental attendance; and (ii) investigate the pain-related disability and quality of life impact of dental conditions which result in urgent dental attendance. METHODOLOGY: Data were collected from those presenting with urgent dental conditions to an out-of-hours dental service, a dental emergency clinic (DEC) and five primary care general dental practices across North-East England. A pre-operative questionnaire explored the impact of urgent dental conditions on oral health-related quality of life (OHRQoL) using Oral Health Impact Profile-14 (OHIP-14) and a modified Graded Chronic Pain Scale (GCPS). OHIP-14 yields a maximum score of 56, with a higher score indicating a lower OHRQoL. Personal financial costs were summed to provide a total. These included travel, appointment fees, childcare costs, medication use and time away from work. Data were analysed using one-way anova and multivariable modelling. RESULTS: In total, 714 participants were recruited. The mean OHIP-14 score was 25.73; 95% CI [24.67, 26.79], GCPS CPI was 71.69; 95% CI [70.09, 73.28] and GCPS interference was 49.56; 95% CI [47.24, 51.87]. Symptomatic irreversible pulpitis was the most frequently managed dental emergency and was associated with the highest mean OHIP-14 score (31.67; 95% CI [30.20, 33.15]). The mean personal financial cost of urgent dental care (UDC) was £85.81; 95% CI [73.29, 98.33]. Differences in travel time (F[2, 691] = 10.24, p < .001), transport costs (F[2, 698] = 4.92, p = .004), and appointment time (F[2, 74] = 9.40, p < .001) were significant between patients attending an out-of-hours dental service, DEC and dental practices for emergency care, with a DEC being associated with the highest costs and dental practices the lowest. CONCLUSIONS: Diseases of the pulp and associated periapical disease were the most common reason for patients to present for UDC and were the most impactful in terms of OHRQoL and pain in the present sample. Personal financial costs are significant from urgent dental conditions, with centralized services increasing the burden to patients of attending appointments.

Development of patient-centric eating advice for complete denture wearers.

BACKGROUND: Edentulous people eat less healthily, and wearing dentures impairs eating function and enjoyment. OBJECTIVE: To apply a sequential approach to integrate scientific evidence, and patient and professional experience to co-develop intervention to support better eating with dentures. METHODS: Focus groups, two with purposive samples of patients and two with dental professionals, explored experiences and opinions about advice on eating with complete dentures. Findings were distilled with evidence from the literature to underpinned concepts for eating interventions. User engagement informed prioritisation of ideas and led to the development of a leaflet on eating with dentures. RESULTS: Patients receive no advice on what they can realistically expect when eating with dentures, and professionals lacked confidence to provide eating advice. Patients did not think dentists a credible provider of eating advice, feeling peer support more appropriate and offering numerous strategies for eating with dentures. Concepts for eating intervention included a patient leaflet, Web-based eating interventions, patient support blogs, waiting room videos and improved nutrition training for dental professionals. User feedback informed prioritisation of ideas, leading to the development of a leaflet on eating with dentures. Justified by the data, the leaflet focused on patient-generated tips for overcoming the functional limitations of eating with dentures, and unobtrusive healthier eating advice. Face validity with users confirmed acceptability. CONCLUSION: A systematic and rigorous integration of scientific evidence, expert experience and patient input has developed a patient-centric, evidence-based approach to a patent leaflet on eating with dentures that, based on initial face validity, is likely to be well received.

Photodynamic versus white-light-guided resection of first-diagnosis non-muscle-invasive bladder cancer: PHOTO RCT.

BACKGROUND: Around 7500 people are diagnosed with non-muscle-invasive bladder cancer in the UK annually. Recurrence following transurethral resection of bladder tumour is common, and the intensive monitoring schedule required after initial treatment has associated costs for patients and the NHS. In photodynamic diagnosis, before transurethral resection of bladder tumour, a photosensitiser that is preferentially absorbed by tumour cells is instilled intravesically. Transurethral resection of bladder tumour is then conducted under blue light, causing the photosensitiser to fluoresce. Photodynamic diagnosis-guided transurethral resection of bladder tumour offers better diagnostic accuracy than standard white-light-guided transurethral resection of bladder tumour, potentially reducing the chance of subsequent recurrence. OBJECTIVE: The objective was to assess the clinical effectiveness and cost-effectiveness of photodynamic diagnosis-guided transurethral resection of bladder tumour. DESIGN: This was a multicentre, pragmatic, open-label, parallel-group, non-masked, superiority randomised controlled trial. Allocation was by remote web-based service, using a 1 : 1 ratio and a minimisation algorithm balanced by centre and sex. SETTING: The setting was 22 NHS hospitals. PARTICIPANTS: Patients aged ≥ 16 years with a suspected first diagnosis of high-risk non-muscle-invasive bladder cancer, no contraindications to photodynamic diagnosis and written informed consent were eligible. INTERVENTIONS: Photodynamic diagnosis-guided transurethral resection of bladder tumour and standard white-light cystoscopy transurethral resection of bladder tumour. MAIN OUTCOME MEASURES: The primary clinical outcome measure was the time to recurrence from the date of randomisation to the date of pathologically proven first recurrence (or intercurrent bladder cancer death). The primary health economic outcome was the incremental cost per quality-adjusted life-year gained at 3 years. RESULTS: We enrolled 538 participants from 22 UK hospitals between 11 November 2014 and 6 February 2018. Of these, 269 were allocated to photodynamic diagnosis and 269 were allocated to white light. A total of 112 participants were excluded from the analysis because of ineligibility (n = 5), lack of non-muscle-invasive bladder cancer diagnosis following transurethral resection of bladder tumour (n = 89) or early cystectomy (n = 18). In total, 209 photodynamic diagnosis and 217 white-light participants were included in the clinical end-point analysis population. All randomised participants were included in the cost-effectiveness analysis. Over a median follow-up period of 21 months for the photodynamic diagnosis group and 22 months for the white-light group, there were 86 recurrences (3-year recurrence-free survival rate 57.8%, 95% confidence interval 50.7% to 64.2%) in the photodynamic diagnosis group and 84 recurrences (3-year recurrence-free survival rate 61.6%, 95% confidence interval 54.7% to 67.8%) in the white-light group (hazard ratio 0.94, 95% confidence interval 0.69 to 1.28; p = 0.70). Adverse event frequency was low and similar in both groups [12 (5.7%) in the photodynamic diagnosis group vs. 12 (5.5%) in the white-light group]. At 3 years, the total cost was £12,881 for photodynamic diagnosis-guided transurethral resection of bladder tumour and £12,005 for white light. There was no evidence of differences in the use of health services or total cost at 3 years. At 3 years, the quality-adjusted life-years gain was 2.094 in the photodynamic diagnosis transurethral resection of bladder tumour group and 2.087 in the white light group. The probability that photodynamic diagnosis-guided transurethral resection of bladder tumour was cost-effective was never > 30% over the range of society's cost-effectiveness thresholds. LIMITATIONS: Fewer patients than anticipated were correctly diagnosed with intermediate- to high-risk non-muscle-invasive bladder cancer before transurethral resection of bladder tumour and the ratio of intermediate- to high-risk non-muscle-invasive bladder cancer was higher than expected, reducing the number of observed recurrences and the statistical power. CONCLUSIONS: Photodynamic diagnosis-guided transurethral resection of bladder tumour did not reduce recurrences, nor was it likely to be cost-effective compared with white light at 3 years. Photodynamic diagnosis-guided transurethral resection of bladder tumour is not supported in the management of primary intermediate- to high-risk non-muscle-invasive bladder cancer. FUTURE WORK: Further work should include the modelling of appropriate surveillance schedules and exploring predictive and prognostic biomarkers. TRIAL REGISTRATION: This trial is registered as ISRCTN84013636. FUNDING: This project was funded by the National Institute for Health and Care Research ( NIHR ) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 40. See the NIHR Journals Library website for further project information.

Around 7500 people are diagnosed with early-stage bladder cancer in the UK each year. Early bladder cancer is contained within the bladder and has not yet invaded the bladder's muscle wall or spread elsewhere in the body. The cancer will return (recur) in around half of people after initial treatment and they have to attend hospital for regular check-ups, with costs to both them and the NHS. The first step in treating early bladder cancer is surgery to remove the tumour. This surgery is normally performed under white light. Photodynamic diagnosis is a new technique in which a liquid is put into the patient's bladder before surgery and a blue light is used during the operation. This causes the bladder cancer to fluoresce so that it can be seen more easily by the surgeon. The Photodynamic versus white-light-guided resection of first diagnosis non-muscle-invasive bladder cancer ( PHOTO ) trial aimed to find out whether or not using photodynamic diagnosis at initial surgery would reduce how often the cancer recurred and whether or not this could reduce the cost of treating early bladder cancer. A total of 538 people with early bladder cancer who had a medium to high chance of their cancer returning after treatment were enrolled in the PHOTO trial. They were included in one of two treatment groups, at random: 269 had photodynamic surgery and 269 had standard white-light surgery. People in both groups were monitored regularly for any recurrences, with further treatment as appropriate. After 3 years, 4 out of 10 people in each group had a recurrence of their bladder cancer. We found no difference between the treatment groups in the number of people with recurrences. We found no evidence of a benefit to patients, and the total costs of photodynamic surgery were higher than those of standard white light. We therefore recommend that it is no longer used in the treatment of this group of patients.

A systematic review of qualitative literature on antimicrobial stewardship in Sub-Saharan Africa.

BACKGROUND: Antibiotic resistance is a major problem in every region of the globe and Sub-Saharan Africa (SSA) is no exception. Several systematic reviews have addressed the prevalence of resistant organisms but few have examined the underlying causes in this region. This systematic review of qualitative literature aims to highlight barriers and facilitators to antimicrobial stewardship in SSA. METHODS: A literature search of Embase and MEDLINE(R) was carried out. Studies were included if they were in English, conducted in SSA, and reported qualitative data on the barriers and facilitators of antimicrobial stewardship or on attitudes towards resistance promoting behaviours. Studies were screened with a simple critical appraisal tool. Secondary constructs were extracted and coded into concepts, which were then reviewed and grouped into themes in light of the complete dataset. RESULTS: The literature search yielded 169 results, of which 14 studies from 11 countries were included in the final analysis. No studies were excluded as a result of the critical appraisal. Eight concepts emerged from initial coding, which were consolidated into five major themes: ineffective regulation, health system factors, clinical governance, patient factors and lack of resources. The ineffective regulation theme highlighted the balance between tightening drugstore regulation, reducing over-the-counter sale of antibiotics, and maintaining access to medicines for rural communities. Meanwhile, health system factors explored the tension between antimicrobial stewardship and the need of pharmacy workers to maintain profitable businesses. Additionally, a lack of resources, actions by patients and the day-to-day challenges of providing healthcare were shown to directly impede antimicrobial stewardship and exacerbate other factors which promote resistance. CONCLUSION: Antibiotic resistance in SSA is a multi-faceted issue and while limited resources contribute to the problem they should be viewed in the context of other factors. We identify several contextual factors that affect resistance and stewardship that should be considered by policy makers when planning interventions. This literature base is also incomplete, with only 11 nations accounted for and many studies being confined to regions within countries, so more research is needed. Specifically, further studies on implementing stewardship interventions, successful or not, would be beneficial to inform future efforts.

Rationing care by frailty during the COVID-19 pandemic.

The coronavirus disease 2019 (COVID-19) pandemic is disproportionately affecting older people and those with underlying comorbidities. Guidelines are needed to help clinicians make decisions regarding appropriate use of limited NHS critical care resources. In response to the pandemic, the National Institute for Health and Care Excellence published guidance that employs the Clinical Frailty Scale (CFS) in a decision-making flowchart to assist clinicians in assessing older individuals' suitability for critical care. This commentary raises some important limitations to this use of the CFS and cautions against the potential for unintended impacts. The COVID-19 pandemic has allowed the widespread implementation of the CFS with limited training or expert oversight. The CFS is primarily being used to assess older individuals' risk of adverse outcome in critical care, and to ration access to care on this basis. While some form of resource allocation strategy is necessary for emergencies, the implementation of this guideline in the absence of significant pressure on resources may reduce the likelihood of older people with frailty, who wish to be considered for critical care, being appropriately considered, and has the potential to reinforce the socio-economic gradient in health. Our incomplete understanding of this novel disease means that there is a need for research investigating the short-term predictive abilities of the CFS on critical care outcomes in COVID-19. Additionally, a review of the impact of stratifying older people by CFS score as a rationing strategy is necessary in order to assess its acceptability to older people as well as its potential for disparate impacts.

Day case laparoscopic cholecystectomy at Kilimanjaro Christian Medical Centre, Tanzania.

INTRODUCTION: The Lancet Commission on Global Surgery has promoted the case for safe, affordable surgical care in low- and middle-income countries (LMICs). In 2017, Kilimanjaro Christian Medical Centre (KCMC) in Tanzania introduced a day case laparoscopic cholecystectomy (DCLC) service, the first of its kind in Sub-Saharan Africa (SSA). We aimed to evaluate this novel service in terms of safety, feasibility and acceptability by patients and staff. METHODS: This study used mixed methods and was split into two stages. In stage 1, we reviewed records of all laparoscopic cholecystectomies (LCs) comparing day cases and admissions. These patients were followed up with a telephone questionnaire to investigate complication rates and receive service feedback. Stage 2 consisted of semi-structured interviews with staff exploring the challenges KCMC faced in implementing DCLC. RESULTS: 147 laparoscopic cholecystectomies were completed: 109 were planned for DCLC, 82 (75.2%) of which were successful, whilst 27 (24.8%) patients were admitted. No variables significantly predicted unplanned admission, the commonest causes for which were pain and nausea. In the DCLC group there was 1 readmission. 62 patients answered the follow up questionnaire, 60 (97%) of which were satisfied with the service. Stage 2 interviews suggested staff to be motivated for DCLC but revealed poor organisation of the day case pathway. CONCLUSION: High rates of DCLC combined with low rates of complications and readmission suggests DCLC is feasible at KCMC. However, staff interviews alluded to administrative problems preventing KCMC from reaching its full DCLC potential. A dedicated day case surgery unit would address most of these problems.

COVID-19 pandemic in the United Kingdom.

OBJECTIVES: To describe epidemiological data on cases of COVID-19 and the spread of Severe Acute Respiratory Syndrome Coronavirus 2 in the United Kingdom (UK), and the subsequent policy and technological response to the pandemic, including impact on healthcare, business and the economy. METHODS: Epidemiological, business and economic data were extracted from official government sources covering the period 31st January to 13th August 2020; healthcare system data up to end of June 2019. RESULTS: UK-wide COVID-19 cases and deaths were 313,798 and 46,706 respectively (472 cases and 70 deaths per 100,000 population) by 12th August. There were regional variations in England, with London and North West (756 and 666 cases per 100,000 population respectively) disproportionately affected compared with other regions. As of 11th August, 13,618,470 tests had been conducted in the UK. Increased risk of mortality was associated with age (≥60 years), gender (male) and BAME groups. Since onset of the pandemic, emergency department attendance, primary care utilisation and cancer referrals and inpatient/outpatient referrals have declined; emergency ambulance and NHS111 calls increased. Business sectors most impacted are the arts, entertainment and recreation, followed by accommodation and food services. Government interventions aimed at curtailing the business and economic impact have been implemented, but applications for state benefits have increased. CONCLUSIONS: The impact of COVID-19 on the UK population, health system and economy has been profound. More data are needed to implement the optimal policy and technological responses to preventing further spikes in COVID-19 cases, and to inform strategic planning to manage future pandemics.

Health-related quality of life and patient-reported outcome measures in NASH-related cirrhosis.

BACKGROUND & AIMS: Non-alcoholic steatohepatitis (NASH) is known to have a negative impact on patients' health-related quality of life (HRQoL), even before progression to cirrhosis has occurred. The burden of NASH-related cirrhosis from the patient perspective remains poorly understood. Herein, we aimed to identify the burden of disease and HRQoL impairment among patients with NASH-related compensated cirrhosis. METHODS: This targeted literature review sought first to identify the humanistic burden of disease from the perspective of patients with diagnosed NASH-cirrhosis and, secondly, to identify generic or disease-specific patient-reported outcome measures (PROMs) used to assess the impact of NASH-cirrhosis. Searches were conducted in bibliographical databases, grey or unpublished literature, liver disease websites, support group websites and online blogs. A quality assessment of specific PROMs was conducted. RESULTS: Patients with NASH-cirrhosis are reported to suffer from lower HRQoL than patients with non-cirrhotic NASH and the general population with respect to physical health/functioning, emotional health and worry, and mental health. Thirteen PROMs were identified, of which 4 were liver-disease specific: CLDQ, CLDQ-NAFLD, LDQoL and LDSI. The most commonly used measures do not comply with current industry or regulatory standards for PROMs and/or are not validated for use in a cirrhotic NASH population. CONCLUSIONS: Patients with NASH-cirrhosis have lower HRQoL and poorer physical health than patients with non-cirrhotic NASH. However, the literature lacked detail of the everyday impact on patients' lives. Currently, a number of PROMs are available to measure the impact of the disease in patients with chronic liver conditions. The lack of studies that include qualitative insights in this population mandates further exploration and research. LAY SUMMARY: It is not well understood how having non-alcoholic fatty liver disease (NAFLD)-related cirrhosis affects a person's everyday wellbeing and quality of life. Some research has been done with patients who have early stages of liver disease but not people with cirrhosis. We found that patients with NAFLD-related cirrhosis tended to have poorer health than patients without cirrhosis. But there was not very much information from patients themselves and there were no tools or questionnaires just for this group of patients.

Challenges in the clinical implementation of a biopsychosocial model for assessment and management of orofacial pain.

Distress, suffering and care-seeking behaviour are characteristics of pain-related disease and illness. Pain that transitions from an acute to a chronic phase carries with it the potential of further effects: these include a worsening of the disease or illness; high-impact chronic pain; and substantial personal, societal and economic burden. The biopsychosocial model directly addresses these multiple processes, yet clinical frameworks supporting this model are not universally implemented. This paper explores barriers to clinical implementation of a full biopsychosocial framework for temporomandibular disorders (TMD) and other oro-facial pain (OFP) conditions. In June 2016, INfORM invited OFP researchers to a workshop designed to optimise the DC/TMD Axis-II. Workshop groups identified five sources of implementation barriers: (1) cultures and societies, (2) levels-of-care settings, (3) health services, (4) cross-cultural validity of self-report instruments and (5) provider and patient health literacy. Three core problems emerged: (A) mental health aspects are seldom fully considered, thus impairing the recognition of illness, (B) training in use of validated multi-axial assessment protocols is under-rated and insufficiently used, and (C) clinical assessment often fails to recognise that sensory and emotional dimensions are fundamental aspects of pain. To improve patient care, these barriers and problems require action. Most importantly, TMD/OFP educators and researchers need to coordinate globally and (i) be educated in the biopsychosocial model, (ii) implement evidence-based biopsychosocial guidelines for assessment and management of OFP conditions at their institutions, (iii) incorporate this model in undergraduate and postgraduate dental curricula and (iv) be responsive to stakeholders, including regulatory authorities and practitioners.

Using Time Trade-Off Methods to Elicit Short-Term Utilities Associated with Treatments for Bulbar Urethral Stricture.

BACKGROUND: Recurrent urethral stricture is usually treated with either open urethroplasty or endoscopic urethrotomy. Both of the procedures cause short-term utility loss, which may not be captured by standard utility questionnaires due to the challenges of completing a standard instrument at the time of an acute episode of short duration, especially within a clinical trial setting. We propose to use time trade-off (TTO) methods to estimate these short-term utility losses. OBJECTIVE: The aim was to compare the use of two alternative TTO methods to elicit patients' short-term utilities following surgical treatments for recurrent urethral stricture. METHOD: Two variants of TTO (chained and conventional) were used. Six health profiles were developed-three for each procedure. Forty participants took part, with 20 randomly allocated to each TTO method. RESULTS: Thirty-eight participants provided usable data for analysis. Estimated utility values decreased as the severity of the health profiles increased. There was no evidence that utility values differed between elicitation methods or procedures for mild {ranging from 0.79 (standard deviation [SD] 0.17) to 0.83 [SD 0.20]} and moderate (ranging from 0.54 [SD 0.24] to 0.67 [SD 0.21]) health states, although they appeared to differ for severe health states (ranging from 0.29 [SD 0.20] to 0.56 [SD 0.24]). CONCLUSION: The study demonstrates the feasibility and value of eliciting patients' short-term utilities. Given the small sample size, the study findings are tentative. Further research with a larger sample size is needed to determine the appropriate TTO method to use and how the elicited utilities can be used in combination with standard cost-utility assessments to aid decision making.

Adolescent perspectives about their participation in alcohol intervention research in emergency care: A qualitative exploration using ethical principles as an analytical framework.

AIMS: To explore adolescents' experiences of consenting to, and participating in, alcohol intervention trials when attending for emergency care. METHODS: In-depth semi-structured interviews with 27 adolescents (16 males; aged 14-17 years (Mage = 15.7)) who had taken part in one of two linked brief alcohol intervention trials based in 10 accident and emergency departments in England. Interviews were transcribed verbatim and subject to thematic analysis. RESULTS: Research and intervention methods were generally found to be acceptable though confidentiality was important and parental presence could hinder truthful disclosures regarding alcohol use. Participants discussed the importance of being involved in research that was relevant to them and recognised alcohol consumption as a normative part of adolescence, highlighting the importance of having access to appropriate health information. Beyond this, they recognised the benefits and risks of trial participation for themselves and others with the majority showing a degree of altruism in considering longer term implications for others as well as themselves. CONCLUSIONS: Alcohol screening and intervention in emergency care is both acceptable and relevant to adolescents but acceptability is reliant on confidentiality being assured and may be inhibited by parental presence. TRIAL REGISTRATION: ISRCTN Number: 45300218.

Correction to: Conducting a Time Trade-Off Study Alongside a Clinical Trial: A Case Study and Recommendations.

The Open Access license, which previously read.

Exploring the role of competing demands and routines during the implementation of a self-management tool for type 2 diabetes: a theory-based qualitative interview study.

BACKGROUND: The implementation of new medical interventions into routine care involves healthcare professionals adopting new clinical behaviours and changing existing ones. Whilst theory-based approaches can help understand healthcare professionals' behaviours, such approaches often focus on a single behaviour and conceptualise its performance in terms of an underlying reflective process. Such approaches fail to consider the impact of non-reflective influences (e.g. habit and automaticity) and how the myriad of competing demands for their time may influence uptake. The current study aimed to apply a dual process theoretical approach to account for reflective and automatic determinants of healthcare professional behaviour while integrating a multiple behaviour approach to understanding the implementation and use of a new self-management tool by healthcare professionals in the context of diabetes care. METHODS: Following Diabetes UK's national release of the 'Information Prescription' (DUK IP; a self-management tool targeting the management of cholesterol, blood pressure and HbA1c) in January 2015, we conducted semi-structured interviews with 13 healthcare professionals (general practitioners and nurses) who had started to use the DUK IP during consultations to provide self-management advice to people with type 2 diabetes. A theory-based topic guide included pre-specified constructs from a previously developed logic model. We elicited healthcare professionals' views on reflective processes (outcome expectations, self-efficacy, intention, action and coping planning), automatic processes (habit), and multiple behaviour processes (goal priority, goal conflict and goal facilitation). All interviews were audio recorded and transcribed verbatim and all transcripts were independently double coded and analysed using content analysis. RESULTS: The majority of healthcare professionals interviewed reported strong intentions to use the DUK IP and having formed a habit of using them after a minimum of one month continuous use. Pop-up cues in the electronic patient records were perceived to facilitate the use of the tool. Factors that conflicted with the use of the DUK IP included existing pathways of providing self-management advice. CONCLUSION: Data suggests that constructs from dual process and multiple behaviour approaches are useful to provide supplemental understanding of the implementation of new self-management tools such as the DUK IP and may help to advance behavioural approaches to implementation science.

Conducting a Time Trade-Off Study Alongside a Clinical Trial: A Case Study and Recommendations.

Time trade-off (TTO) is an established method in health economics to elicit and value individuals' preferences for different health states. These preferences are expressed in the form of health-state utilities that are typically used to measure health-related quality of life and calculate quality-adjusted life-years in an economic evaluation. The TTO approach to directly elicit health-state utilities is particularly valuable when generic instruments (e.g. EQ-5D) may not fully capture changes in utility in a clinical trial. However, there is limited guidance on how a TTO study should be conducted alongside a clinical trial despite it being a valuable tool. We present an account of the design and development of a TTO study within a clinical trial as a case study. We describe the development of materials needed for the TTO interviews, the piloting of the TTO materials and interview process, and recommendations for future TTO studies. This paper provides a practical guide and reference for future applications of the TTO method alongside a clinical trial.

A web-based intervention (RESTORE) to support self-management of cancer-related fatigue following primary cancer treatment: a multi-centre proof of concept randomised controlled trial.

PURPOSE: Cancer-related fatigue (CRF) is a frequent and distressing symptom experienced after cancer treatment. RESTORE is the first web-based resource designed to enhance self-efficacy to manage CRF following curative-intent treatment. The aim of this study is to test the proof of concept and inform the design of an effectiveness trial. METHODS: A multi-centre parallel-group two-armed (1:1) exploratory randomised controlled trial (RCT) with qualitative process evaluation was employed in the study. Participants (≥18 years; ≤5 years post treatment with moderate to severe fatigue) were recruited and randomly assigned to RESTORE or a leaflet. Feasibility and acceptability were measured by recruitment, attrition, intervention adherence, completion of outcome measures and process evaluation. Change in self-efficacy to manage CRF was also explored. Outcome measures were completed at baseline (T0), 6 weeks (T1) and 12 weeks (T2). Data were analysed using mixed-effects linear regression and directed content analysis. RESULTS: One hundred and sixty-three people participated in the trial and 19 in the process evaluation. The intervention was feasible (39 % of eligible patients consented) and acceptable (attrition rate 36 %). There was evidence of higher fatigue self-efficacy at T1 in the intervention group vs comparator (mean difference 0.51 [-0.08 to 1.11]), though the difference in groups decreased by 12 weeks. Time since diagnosis influenced perceived usefulness of the intervention. Modifications were suggested. CONCLUSION: Proof of concept was achieved. The RESTORE intervention should be subject to a definitive trial with some adjustments. Provision of an effective supportive resource would empower cancer survivors to manage CRF after treatment completion. TRIAL REGISTRATION: ISRCTN67521059.

"I assumed that one was a placebo": exploring the consent process in a sham controlled acupressure trial.

OBJECTIVES: In clinical trials where participants are likely to be able to distinguish between true and sham interventions, informing participants that they may receive a sham intervention increases the likelihood of participants 'breaking the blind' and invalidating trial findings. The present study explored participants' perceptions of the consent process in a sham controlled acupressure trial which did not explicitly indicate participants may receive a sham intervention. DESIGN: Nested qualitative study within a randomised sham controlled trial of acupressure wristbands for chemotherapy-related nausea. Convenience sample of 26 patients participated in semi-structured interviews. Interviews were audio-recorded and transcribed verbatim. Transcripts analysed thematically using framework analysis. SETTING: Study conducted within three geographical sites in the UK: Manchester, Liverpool, and Plymouth. RESULTS: All participants indicated that they believed they were fully informed when providing written consent to participate in the trial. Participants' perceived it was acceptable to employ a sham intervention within the trial of acupressure wristbands without informing potential participants that they may receive a sham treatment. Despite the fact that participants were not informed that one of the treatment arms was a sham intervention the majority indicated they assumed one of the treatment arms would be placebo. CONCLUSIONS: Many trials of acupuncture and acupressure do not inform participants they may receive a sham intervention. The current study indicates patients' perceive this approach to the consent process as acceptable. However, the fact participants assume one treatment may be placebo threatens the methodological basis for utilising this approach to the consent process.