Adapting the EQ-5D-3L for adults with mild to moderate learning disabilities.

BACKGROUND: Approximately 1.5 million adults in the UK have a learning disability. The difference between age at death for this group and the general population is 26 years for females and 22 years for males. The NHS Long Term Plan (January 2019) recognises learning disabilities as a clinical priority area. People with a learning disability are often excluded from research by design or lack of reasonable adjustments, and self-reported health status/health-related quality of life questionnaires such as the EQ-5D are often not appropriate for this population. Here, we systematically examine the EQ-5D-3L (its wording, content, and format) using qualitative methods to inform the adaption of the measure for use with adults with mild to moderate learning disabilities. METHODS: Think-aloud interviews with carers/advocates of learning-disabled adults were undertaken to explore the difficulties with completing the EQ-5D-3L. Alternative wording, language, structure, and images were developed using focus groups, stakeholder reference groups, and an expert panel. Data analysis followed a framework method. RESULTS: The dimensions and levels within the EQ-5D-3L were deemed appropriate for adults with mild to moderate learning disabilities. Consensus on wording, structure, and images was reached through an iterative process, and an adapted version of the EQ-5D-3L was finalised. CONCLUSION: The EQ-5D-3L adapted for adults with mild to moderate intellectual/learning disabilities can facilitate measurement of self-reported health status. Research is underway to assess the potential use of the adaptation for economic evaluation.

The Smarter Safer Homes Solution to Support Older People Living in Their Own Homes Through Enhanced Care Models: Protocol for a Stratified Randomized Controlled Trial.

BACKGROUND: An aging population, accompanied by the prevalence of age-related diseases, presents a significant burden to health systems. This is exacerbated by an increasing shortage of aged care staff due to the existing workforce entering their retirement and fewer young people being attracted to work in aged care. In line with consumer preferences and potential cost-efficiencies, government and aged care providers are increasingly seeking options to move care and support to the community or home as opposed to residential care facilities. However, compared to residential care, home environments may provide limited opportunity for monitoring patients' progression/decline in functioning and therefore limited opportunity to provide timely intervention. To address this, the Smarter Safer Homes (SSH) platform was designed to enable self-monitoring and/or management, and to provide aged care providers with support to deliver their services. The platform uses open Internet of Things communication protocols to easily incorporate commercially available sensors into the system. OBJECTIVE: Our research aims to detail the benefits of utilizing the SSH platform as a service in its own right as well as a complementary service to more traditional/historical service offerings in aged care. This work is anticipated to validate the capacity and benefits of the SSH platform to enable older people to self-manage and aged care service providers to support their clients to live functionally and independently in their own homes for as long as possible. METHODS: This study was designed as a single-blinded, stratified, 12-month randomized controlled trial with participants recruited from three aged care providers in Queensland, Australia. The study aimed to recruit 200 people, including 145 people from metropolitan areas and 55 from regional areas. Participants were randomized to the intervention group (having the SSH platform installed in their homes to assist age care service providers in monitoring and providing timely support) and the control group (receiving their usual aged care services from providers). Data on community care, health and social-related quality of life, health service utilization, caregiver burden, and user experience of both groups were collected at the start, middle (6 months), and end of the trial (12 months). RESULTS: The trial recruited its first participant in April 2019 and data collection of the last participant was completed in November 2020. The trial eventually recruited 195 participants, with 98 participants allocated to the intervention group and 97 participants allocated to the control group. The study also received participants' health service data from government data resources in June 2021. CONCLUSIONS: A crisis is looming to support the aging population. Digital solutions such as the SSH platform have the potential to address this crisis and support aged care in the home and community. The outcomes of this study could improve and support the delivery of aged care services and provide better quality of life to older Australians in various geographical locations. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12618000829213; https://tinyurl.com/2n6a75em. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/31970.

Transforming challenges into opportunities: conducting health preference research during the COVID-19 pandemic and beyond.

The disruptions to health research during the COVID-19 pandemic are being recognized globally, and there is a growing need for understanding the pandemic's impact on the health and health preferences of patients, caregivers, and the general public. Ongoing and planned health preference research (HPR) has been affected due to problems associated with recruitment, data collection, and data interpretation. While there are no "one size fits all" solutions, this commentary summarizes the key challenges in HPR within the context of the pandemic and offers pragmatic solutions and directions for future research. We recommend recruitment of a diverse, typically under-represented population in HPR using online, quota-based crowdsourcing platforms, and community partnerships. We foresee emerging evidence on remote, and telephone-based HPR modes of administration, with further studies on the shifts in preferences related to health and healthcare services as a result of the pandemic. We believe that the recalibration of HPR, due to what one would hope is an impermanent change, will permanently change how we conduct HPR in the future.

An International Comparison of EQ-5D-5L and EQ-5D-3L for Use in Cost-Effectiveness Analysis.

OBJECTIVES: To estimate the impact of using EQ5D-5L (5L) compared with EQ5D-3L (3L) in cost-effectiveness analyses in 6 countries with 3L and 5L values: Germany, Japan, Korea, The Netherlands, China, and Spain. METHODS: Eight cost-effectiveness analyses based on clinical studies with 3L provided 11 pairwise comparisons. We estimated cost-effectiveness by applying the appropriate country values for 3L to observed responses. We re-estimated cost-effectiveness for each country by predicting the 5L tariff score for each respondent, for each country, using a previously published mapping method. We compared results in terms of impact on estimated incremental quality-adjusted life-year (QALY) gain and cost-effectiveness ratios. RESULTS: For most countries the impact of moving from 3L to 5L is to lower the incremental QALY gain in the majority of comparisons. The only exception to this was Japan, where 4 out of 11 cases (37%) saw lower QALYs gained when using 5L. The mean and median reductions in health gain, in those case studies where 5L does lead to lower health gain, are largest in The Netherlands (84% mean reduction, 41% median reduction), Germany (68% and 27%), and Spain (30% and 31%). For most countries, those studies where 5L leads to lower health gain see larger reductions than the gains in studies showing the opposite tendency. CONCLUSIONS: Overall, 3L and 5L are not interchangeable in these countries. Differences between results are large, but the direction of change can be unpredictable. These findings should prompt further investigation into the reasons for differences.

Identifying 'at-risk' critically ill patients who present to the emergency department and require intensive care unit admission: A retrospective observational cohort study.

BACKGROUND: Emergency department (ED) triage is the process of prioritising patients by medical urgency. Delays in intensive care unit (ICU) admission can adversely affect patients. OBJECTIVES: This study aimed to identify characteristics associated with ICU admission for patients triaged as Australasian Triage Scale (ATS) 3 but subsequently admitted to the ICU within 24 h of triage. METHODS: This retrospective, observational cohort study was conducted in a public teaching hospital in Queensland, Australia. Patients older than 18 y triaged with an ATS 3 and admitted to the ICU within 24 h of triage or admitted to the ward between January 1, 2012, and December 31, 2012, were included. The demographic and clinical profiles of ICU admissions vs. all other ward admissions for patients triaged an ATS of 3 were compared. Multivariable regression analysis compared characteristics of patients triaged with an ATS of 3 who did and did not require ICU transfer. Descriptive data are reported as n (%) and median and interquartile range (IQR). Regression analysis is reported as adjusted odds ratios (aORs) with 95% confidence intervals (95% CIs). RESULTS: Of the 27 454 adult ED presentations triaged with an ATS of 3, 22.4% (n = 6138) required hospital admission, comprising 5302 individuals, 2.1% of whom (n = 110) were admitted to the ICU within 24 h of triage. Age- and sex-adjusted predictors of ICU admission for patients triaged with an ATS of 3 included infectious (aOR: 3.7; 95% CI: 2.0-6.9), neurological (aOR: 2.8; 95% CI: 1.6-5.0), and gastrointestinal disorders (aOR: 2.2; 95% CI 1.2-3.5); arriving by ambulance; arriving after hours; or arriving on weekends. Regardless of diagnosis or sex, persons older than 80 y were less likely to be admitted to the ICU (aOR: 0.4; 95% CI: 0.2-0.8). CONCLUSIONS: Patients triaged as ATS 3 presenting on weekends or after hours, and those with infectious, gastrointestinal, or neurological conditions warrant careful attention as these factors were associated with higher odds of ICU admission. Ongoing staff education regarding triage and signs of deterioration are important to prevent avoidable outcomes.

Problem-solving therapy rather than treatment as usual for adults after self-harm: a pragmatic, feasibility, randomised controlled trial (the MIDSHIPS trial).

BACKGROUND: Non-fatal self-harm is one of the commonest reasons for adults' emergency hospital attendance. Although strongly associated with fatal and non-fatal repetition, there is weak evidence about effective interventions-and no clear NICE guidance or clinical consensus concerning aftercare. We examined the practicability of a definitive trial to evaluate problem-solving therapy (PST) to reduce repetition of self-harm; MIDSHIPS is a single-centre, parallel-group, individually randomised controlled feasibility trial comparing treatment-as-usual (TAU) alone to TAU plus up to six sessions of brief problem-solving therapy (PST) with adults who had recently attended hospital because of self-harm. Objectives were to adapt the intervention for a UK setting, train therapists, recruit and randomise patients, deliver PST under supervision, and establish comparative outcomes, assessed blindly. METHODS: We adapted the problem-solving intervention from an earlier trial and trained a mental-health nurse to deliver it. Adult patients attending the general hospital for self-harm were recruited while undergoing psychosocial assessment by the mental health team, and 62 were randomly allocated (32 TAU, 30 PST). The primary outcome assessed repeat hospital attendance due to further self-harm 6 months post-randomisation. Secondary outcomes included participant-reported outcomes and service use at 3 and 6 months post-randomisation. RESULTS: The recruitment period had to be extended and 710 patients screened in order to establish a trial sample of the planned size (N = 62). A quarter of participants allocated to PST did not undertake the therapy offered; those who received PST attended a median of three sessions. Secondary outcomes were established for 49 (79%) participants at 6 months; all participants' hospital records were retrieved. Repetition of self-harm leading to hospital presentation occurred in 19 of the 62 participants (30.6%, 95% CI 19.2%, 42.1%) within 6 months of randomisation. Promising differential rates of self-harm were observed with an event rate of 23.3% (95% CI 8.2%, 38.5%) in the PST arm; and 37.5% (95% CI 20.7%, 54.3%) in TAU. Economic findings were also encouraging, with a small QALY gain (0.0203) in the PST arm together with less reported use of the NHS in the PST arm (average £2120) than with TAU-only (£2878). CONCLUSIONS: The feasibility trial achieved its objectives despite considerable difficulties with recruitment-adapting the PST, training a therapist, recruiting patients who had recently self-harmed, delivering the therapy, and establishing primary and secondary outcomes. These data provide a robust platform for a definitive multicentre randomised controlled trial of brief problem-solving therapy after hospital attendance due to self-harm. TRIAL REGISTRATION: Identification number and URL: ISRCTN54036115 http://www.isrctn.com/search?q=midships. Registered: 13 January 2012.

Patients with mental health conditions in the emergency department: Why so long a wait?

OBJECTIVES: Patients presenting with a mental health disorder (MHD) wait longer in the ED compared to those presenting for other reasons, potentially placing vulnerable patients at further risk for deterioration. The present study identified factors associated with a long ED stay for patients with a MHD. METHODS: Linked ambulance, emergency, pathology, imaging and admission data for an 18-month period were analysed for ED presentations diagnosed with an MHD ICD-10 at a large teaching hospital. Admissions and discharges were considered separately; a long ED stay was defined as the 90th percentile length of stay. Multivariable generalised linear models were built, identifying predictors of a long ED stay for presentations diagnosed with a MHD. RESULTS: The sample comprised 1163 admissions and 2242 discharges. For admissions, significant predictors for long ED stay were investigations (pathology or imaging tests), a triage score of 1 or 2, arrival out-of-hours (18.00-05.59 hours) and arrival by ambulance. For discharges, significant predictors of a long ED stay were investigations (pathology or imaging tests), arrival out-of-hours, arrival by ambulance and increasing age. CONCLUSIONS: Some factors predictive of a long ED stay for patients presenting to the ED and diagnosed with a MHD varied based on their disposition. For admissions, the most urgent presentations were likely to stay longest. Strategies to reduce ED stay for both admissions and discharges should consider addressing modifiable aspects, including the need for certain investigations, and non-modifiable aspects, including the need for further access to after-hours mental health services in hospital and in the community.

Generating high-quality data abstractions from scanned clinical records: text-mining-assisted extraction of endometrial carcinoma pathology features as proof of principle.

OBJECTIVE: Medical research studies often rely on the manual collection of data from scanned typewritten clinical records, which can be laborious, time consuming and error prone because of the need to review individual clinical records. We aimed to use text mining to assist with the extraction of clinical features from complex text-based scanned pathology records for medical research studies. DESIGN: Text mining performance was measured by extracting and annotating three distinct pathological features from scanned photocopies of endometrial carcinoma clinical pathology reports, and comparing results to manually abstracted terms. Inclusion and exclusion keyword trigger terms to capture leiomyomas, endometriosis and adenomyosis were provided based on expert knowledge. Terms were expanded with character variations based on common optical character recognition (OCR) error patterns as well as negation phrases found in sample reports. The approach was evaluated on an unseen test set of 1293 scanned pathology reports originating from laboratories across Australia. SETTING: Scanned typewritten pathology reports for women aged 18-79 years with newly diagnosed endometrial cancer (2005-2007) in Australia. RESULTS: High concordance with final abstracted codes was observed for identifying the presence of three pathology features (94%-98% F-measure). The approach was more consistent and reliable than manual abstractions, identifying 3%-14% additional feature instances. CONCLUSION: Keyword trigger-based automation with OCR error correction and negation handling proved not only to be rapid and convenient, but also providing consistent and reliable data abstractions from scanned clinical records. In conjunction with manual review, it can assist in the generation of high-quality data abstractions for medical research studies.

Transforming discrete choice experiment latent scale values for EQ-5D-3L using the visual analogue scale.

BACKGROUND: Discrete choice experiments (DCEs) are widely used to elicit health state preferences. However, additional information is required to transform values to a scale with dead valued at 0 and full health valued at 1. This paper presents DCE-VAS, an understandable and easy anchoring method with low participant burden based on the visual analogue scale (VAS). METHODS: Responses from 1450 members of the UK general public to a discrete choice experiment (DCE) were analysed using mixed logit models. Latent scale valuations were anchored to a full health = 1, dead = 0 scale using participants' VAS ratings of three states including the dead. The robustness of results was examined. This included a filtering procedure with the influence each individual respondent had on valuation being calculated, and those whose influence was more than two standard deviations away from the mean excluded. RESULTS: Coefficients in all models were in the expected direction and statistically significant. Excluding respondents who self-reported not understanding the VAS task did not significantly influence valuation, but excluding a small number who valued 33333 extremely low did. However, after eight respondents were removed via the filtering procedure, valuations were robust to removing other participants. CONCLUSION: DCE-VAS is a feasible way of anchoring DCE results to a 0-1 anchored scale with low additional respondent burden.

Co-existence of leiomyomas, adenomyosis and endometriosis in women with endometrial cancer.

Leiomyomas, adenomyosis, and endometriosis are reported to be risk factors for endometrial carcinoma (EC), and adenomyosis and endometriosis also for ovarian carcinoma (OC). We aimed to describe the prevalence of these conditions in EC patients with or without an OC diagnosis, and to investigate their relationship with EC risk and prognostic factors in these patients. We evaluated the co-existence of these three conditions in 1399 EC patients, and compared the prevalence of epidemiological risk factors and tumor prognostic features in patients with each condition versus not. Prevalence of conditions was also assessed in the subset of patients with prior/concurrent OC. The observed coexistence of leiomyomas, adenomyosis and endometriosis significantly deviated from that expected (P = 1.2 × 10-8). Patients were more likely to: report a younger age at menarche (PTrend = 0.004) if they had leiomyomas; have used oral contraceptives (P = 6.6 × 10-5) or had ≥2 full-term pregnancies (PTrend = 2.0 × 10-9) if they had adenomyosis; be diagnosed with EC at younger age (P = 5.0 × 10-11) if they had endometriosis. Patients with prior/concurrent OC were more likely to be diagnosed at younger age (P = 5.0 × 10-5), have endometriosis (P = 9.9 × 10-7), and present with higher stage EC (PTrend = 6.6 × 10-5). These findings justify further consideration of these gynecologic conditions as independent risk and prognostic factors for EC.

Predictors of a long length of stay in the emergency department for older people.

BACKGROUND: Dedicated geriatric models of care are becoming more prevalent due to the complexity of, and increase in, acute healthcare presentations for older patients. For older people, a long stay in the emergency department (ED) may reflect the complexity of their presentation, or deficiencies in systems that manage these complexities. AIMS: To identify predictors of a long ED length of stay (LLoS) for patients ≥65 years old. METHODS: Linked hospital information systems data from a large, public Australian ED were analysed in this retrospective cohort study. LLoS was defined as the 75th percentile (617 min). Multivariate regression identified LLoS predictors for admissions and discharges separately. RESULTS: Of 16 791 ED presentations made by older people, 4192 experienced a LLoS; 55% were admitted. Increasing age was associated with an increasing ED LoS. Factors most predictive of LLoS for both admitted and discharged patients included: investigations (both pathology and imaging), less urgent Australasian triage scale categories and after-hours arrival. Ambulance arrival did not increase the risk of a LLoS for patients eventually admitted, but conferred nearly a twofold increased risk for a LLoS for discharged older persons (adjusted odds ratios = 1.9; 95% confidence interval 1.5-2.4). CONCLUSIONS: This study assists clinicians and decision-makers to identify reasons why older persons have a LLoS, whether admitted or discharged. Interventions to streamline care for older patients arriving after-hours and who require imaging and pathology are required. LoS targets should consider age distribution. The use of ED LoS as a quality of care indicator should be assessed for admissions and discharges, separately.

Improving emergency department transfer for patients arriving by ambulance: A retrospective observational study.

OBJECTIVE: Extended delays in the transfer of patients from ambulance to ED can compromise patient flow. The present study aimed to describe the relationship between the use of an Emergency Department Ambulance Off-Load Nurse (EDAOLN) role, ED processes of care and cost effectiveness. METHODS: This was a retrospective observational study over three periods of before (T1), during (T2) and after (T3) the introduction of the EDAOLN role in 2012. Ambulance, ED and cost data were linked and used for analysis. Processes of care measures analysed included: time to be seen by a doctor from ED arrival (primary outcome), ambulance-ED offload compliance, proportion of patients seen within recommended triage timeframe, ED length of stay (LoS), proportion of patients transferred, admitted or discharged from the ED within 4 h and cost effectiveness. RESULTS: A total of 6045 people made 7010 presentations to the ED by ambulance over the study period. Several measures improved significantly between T1 and T2 including offload compliance (T1: 58%; T2: 63%), time to be seen (T1: 31 min; T2: 28 min), ED LoS (T1: 335 min; T2: 306 min), ED LoS <4 h (T1: 31%; T2: 33%). Some measures carried over into T3, albeit to a lesser extent. Post-hoc analyses showed that outcomes improved most for less urgent patients. The annualised net cost of the EDAOLN (if funded from additional resources) of $130 721 could result in an annualised reduction of approximately 3912 h in waiting time to be seen by a doctor. CONCLUSION: With the EDAOLN role in place, slight outcome improvements in several key ambulance and ED efficiency criteria were noted. During times of ED crowding, the EDAOLN role may be one cost-effective strategy to consider.

A Decision Support System for Pathology Test Result Reviews in an Emergency Department to Support Patient Safety and Increase Efficiency.

The review of pathology test results for missed diagnoses in Emergency Departments is time-consuming, laborious, and can be inaccurate. An automated solution, with text mining and clinical terminology semantic capabilities, was developed to provide clinical decision support. The system focused on the review of microbiology test results that contained information on culture strains and their antibiotic sensitivities, both of which can have a significant impact on ongoing patient safety and clinical care. The system was highly effective at identifying abnormal test results, reducing the number of test results for review by 92%. Furthermore, the system reconciled antibiotic sensitivities with documented antibiotic prescriptions in discharge summaries to identify patient follow-ups with a 91% F-measure - allowing for the accurate prioritization of cases for review. The system dramatically increases accuracy, efficiency, and supports patient safety by ensuring important diagnoses are recognized and correct antibiotics are prescribed.

Cost-Effectiveness of Pain Management Strategies in Advanced Cancer.

OBJECTIVES: Uncontrolled pain in advanced cancer is a common problem and has significant impact on individuals' quality of life and use of healthcare resources. Interventions to help manage pain at the end of life are available, but there is limited economic evidence to support their wider implementation. We conducted a case study economic evaluation of two pain self-management interventions (PainCheck and Tackling Cancer Pain Toolkit [TCPT]) compared with usual care. METHODS: We generated a decision-analytic model to facilitate the evaluation. This modelled the survival of individuals at the end of life as they moved through pain severity categories. Intervention effectiveness was based on published meta-analyses results. The evaluation was conducted from the perspective of the U.K. health service provider and reported cost per quality-adjusted life-year (QALY). RESULTS: PainCheck and TCPT were cheaper (respective incremental costs -GBP148 [-EUR168.53] and -GBP474 [-EUR539.74]) and more effective (respective incremental QALYs of 0.010 and 0.013) than usual care. There was a 65 percent and 99.5 percent chance of cost-effectiveness for PainCheck and TCPT, respectively. Results were relatively robust to sensitivity analyses. The most important driver of cost-effectiveness was level of pain reduction (intervention effectiveness). Although cost savings were modest per patient, these were considerable when accounting for the number of potential intervention beneficiaries. CONCLUSIONS: Educational and monitoring/feedback interventions have the potential to be cost-effective. Economic evaluations based on estimates of effectiveness from published meta-analyses and using a decision modeling approach can support commissioning decisions and implementation of pain management strategies.

Patients admitted via the emergency department to the intensive care unit: An observational cohort study.

OBJECTIVE: Timely and appropriate assessment and management within the ED impacts patient outcomes including in-hospital mortality and length of stay (LOS). Within the ED, several processes facilitate timely recognition of the need for intensive care unit (ICU) admission. This study describes characteristics and outcomes for patient presentations admitted to ICU from ED, categorised by Australasian Triage Score (ATS), ICU admission time and ICU admission source. METHODS: A retrospective observational cohort study with linked health data of adult ICU admissions during 2012. Outcomes measured included: ED, ICU and hospital LOS, time to see ED clinician, ICU readmission and ICU and hospital mortality rates. RESULTS: In total, 423 ICU admissions occurred within 24 h of ED arrival; 395 were admitted directly to ICU; 28 were admitted to the ward before ICU admission. ATS 3/4/5 patients comprised 26.7% of ICU admissions and experienced longer waits to be seen, longer total ED LOS, shorter ICU LOS and a lower mortality rate than those triaged ATS 1/2. Compared to ICU admissions during business hours, admissions outside hours did not differ significantly for any outcome measured. Patients admitted to the ward before ICU experienced longer waits to be seen and longer ED LOS. CONCLUSION: Most patients are appropriately identified in ED as requiring ICU admission, although around one in four were triaged ATS 3/4. Patients admitted to the ward first tended to have poorer outcomes than those directly admitted to ICU. Factors predicting the need for ICU admission should be identified to support clinical decision-making.

Extracting tumour prognostic factors from a diverse electronic record dataset in genito-urinary oncology.

OBJECTIVES: To implement a system for unsupervised extraction of tumor stage and prognostic data in patients with genitourinary cancers using clinicopathological and radiology text. METHODS: A corpus of 1054 electronic notes (clinician notes, radiology reports and pathology reports) was annotated for tumor stage, prostate specific antigen (PSA) and Gleason grade. Annotations from five clinicians were reconciled to form a gold standard dataset. A training dataset of 386 documents was sequestered. The Medtex algorithm was adapted using the training dataset. RESULTS: Adapted Medtex equaled or exceeded human performance in most annotations, except for implicit M stage (F-measure of 0.69 vs 0.84) and PSA (0.92 vs 0.96). Overall Medtex performed with an F-measure of 0.86 compared to human annotations of 0.92. There was significant inter-observer variability when comparing human annotators to the gold standard. CONCLUSIONS: The Medtex algorithm performed similarly to human annotators for extracting stage and prognostic data from varied clinical texts.

Managing with Learning Disability and Diabetes: OK-Diabetes - a case-finding study and feasibility randomised controlled trial.

BACKGROUND: Obesity and type 2 diabetes are common in adults with a learning disability. It is not known if the principles of self-management can be applied in this population. OBJECTIVES: To develop and evaluate a case-finding method and undertake an observational study of adults with a learning disability and type 2 diabetes, to develop a standardised supported self-management (SSM) intervention and measure of adherence and to undertake a feasibility randomised controlled trial (RCT) of SSM versus treatment as usual (TAU). DESIGN: Observational study and an individually randomised feasibility RCT. SETTING: Three cities in West Yorkshire, UK. PARTICIPANTS: In the observational study: adults aged > 18 years with a mild or moderate learning disability, who have type 2 diabetes that is not being treated with insulin and who are living in the community. Participants had mental capacity to consent to research and to the intervention. In the RCT participants had glycated haemoglobin (HbA1c) levels of > 6.5% (48 mmol/mol), a body mass index (BMI) of > 25 kg/m2 or self-reported physical activity below national guideline levels. INTERVENTIONS: Standardised SSM. TAU supported by an easy-read booklet. MAIN OUTCOME MEASURES: (1) The number of eligible participants identified and sources of referral; (2) current living and support arrangements; (3) current health state, including level of HbA1c, BMI and waist circumference, blood pressure and lipids; (4) mood, preferences for change; (5) recruitment and retention in RCT; (6) implementation and adherence to the intervention; (7) completeness of data collection and values for candidate primary outcomes; and (8) qualitative data on participant experience of the research process and intervention. RESULTS: In the observational study we identified 147 eligible consenting participants. The mean age was 54.4 years. In total, 130 out of 147 (88%) named a key supporter, with 113 supporters (77%) being involved in diabetes management. The mean HbA1c level was 54.5 mmol/mol [standard deviation (SD) 14.8 mmol/mol; 7.1%, SD 1.4%]. The BMI of 65% of participants was > 30 kg/m2 and of 21% was > 40 kg/m2. Many participants reported low mood, dissatisfaction with lifestyle and diabetes management and an interest in change. Non-response rates were high (45/147, 31%) for medical data requested from the primary care team. In the RCT, 82 participants were randomised. The mean baseline HbA1c level was 56 mmol/mol (SD 16.5 mmol/mol; 7.3%, SD 1.5%) and the mean BMI was 34 kg/m2 (SD 7.6 kg/m2). All SSM sessions were completed by 35 out of 41 participants. The adherence measure was obtained in 37 out of 41 participants. The follow-up HbA1c level and BMI was obtained for 75 out of 82 (91%) and 77 out of 82 (94%) participants, respectively. Most participants reported a positive experience of the intervention. A low response rate and difficulty understanding the EuroQol-5 Dimensions were challenges in obtaining data for an economic analysis. LIMITATIONS: We recruited from only 60% of eligible general practices, and 90% of participants were on a general practice learning disability register, which meant that we did not recruit many participants from the wider population with milder learning disability. CONCLUSIONS: A definitive RCT is feasible and would need to recruit 194 participants per arm. The main barrier is the resource-intensive nature of recruitment. Future research is needed into the effectiveness of obesity treatments in this population, particularly estimating the longer-term outcomes that are important for health benefit. Research is also needed into improving ways of assessing quality of life in adults with a learning disability. TRIAL REGISTRATION: Current Controlled Trials ISRCTN41897033. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 26. See the NIHR Journals Library website for further project information.

Developing and feasibility testing of data collection methods for an economic evaluation of a supported selfmanagement programme for adults with a learning disability and type 2 diabetes.

BACKGROUND: The challenges of conducting research with hard to reach vulnerable groups are particularly pertinent for people with learning disabilities. Data collection methods for previous cost and cost-effectiveness analyses of health and social care interventions targeting people with learning disabilities have relied on health care/health insurance records or data collection forms completed by the service provider rather than by people with learning disabilities themselves. This paper reports on the development and testing of data collection methods for an economic evaluation within a randomised controlled trial (RCT) for a supported self-management programme for people with mild/moderate learning disabilities and type 2 diabetes. METHODS: A case finding study was conducted to identify types of health and social care use and data collection methods employed in previous studies with this population. Based on this evidence, resource use questionnaires for completion by GP staff and interviewer-administered participant questionnaires (covering a wider cost perspective and health-related quality of life) were tested within a feasibility RCT. Interviewer-administered questionnaires included the EQ-5D-3L (the NICE recommended measure for use in economic evaluation). Participants were adults > 18 years with a mild or moderate learning disability and type 2 diabetes, with mental capacity to give consent to research participation. RESULTS: Data collection for questionnaires completed by GP staff requesting data for the last 12 months proved time intensive and difficult. Whilst 82.3% (121/147) of questionnaires were returned, up to 17% of service use items were recorded as unknown. Subsequently, a shorter recall period (4 months) led to a higher return rate but with a higher rate of missing data. Missing data for interviewer-administered participant questionnaires was > 8% but the interviewers reported difficulty with participant recall. Almost 60% (48/80) of participants had difficulty completing the EQ-5D-3L. CONCLUSIONS: Further investigation as to how service use can be recorded is recommended. Concerns about the reliability of identifying service use data directly from participants with a learning disability due to challenges in completion, specifically around recall, remain. The degree of difficulty to complete EQ-5D-3L indicates concerns regarding the appropriateness of using this measure in its current form in research with this population. TRIAL REGISTRATION: Current Controlled Trials ISRCTN41897033 (registered 21 January 2013).

Improving the management of pain from advanced cancer in the community: study protocol for a pragmatic multicentre randomised controlled trial.

INTRODUCTION: For patients with advanced cancer, research shows that pain is frequent, burdensome and undertreated. Evidence-based approaches to support cancer pain management have been developed but have not been implemented within the context of the UK National Health Service. This protocol is for a pragmatic multicentre randomised controlled trial (RCT) to assess feasibility, acceptability, effectiveness and cost-effectiveness for a multicomponent intervention for pain management in patients with advanced cancer. METHODS AND ANALYSIS: This trial will assess the feasibility of implementation and uptake of evidence-based interventions, developed and piloted as part of the Improving the Management of Pain from Advanced Cancer in the Community Programme grant, into routine clinical practice and determine whether there are potential differences with respect to patient-rated pain, patient pain knowledge and experience, healthcare use, quality of life and cost-effectiveness. 160 patients will receive either the intervention (usual care plus supported self-management) delivered within the oncology clinic and palliative care services by locally assigned community palliative care nurses, consisting of a self-management educational intervention and eHealth intervention for routine pain assessment and monitoring; or usual care. The primary outcomes are to assess implementation and uptake of the interventions, and differences in terms of pain severity. Secondary outcomes include pain interference, participant pain knowledge and experience, and cost-effectiveness. Outcome assessment will be blinded and patient-reported outcome measures collected via post at 6 and 12 weeks following randomisation. ETHICS AND DISSEMINATION: This RCT has the potential to significantly influence National Health Service delivery to community-based patients with pain from advanced cancer. We aim to provide definitive evidence of whether two simple interventions delivered by community palliative care nurse in palliative care that support-self-management are clinically effective and cost-effective additions to standard community palliative care. TRIAL REGISTRATION NUMBER: ISRCTN18281271; Pre-results.