Evaluation of a type 2 diabetes prevention program using a commercial weight management provider for non-diabetic hyperglycemic patients referred by primary care in the UK

Objectives: To determine if a diabetes prevention program (DPP) delivered by a commercial weight management provider using a UK primary care referral pathway could reduce the progression to type 2 diabetes (T2D) in those diagnosed with non-diabetic hyperglycemia (NDH—being at high risk of developing T2D). Research design: This is a quasi-experimental translational research study. Methods: 14 primary care practices identified, recruited and referred patients with NDH (fasting plasma glucose ≥5.5 to ≤6.9mmol/L and/or glycated hemoglobin (HbA1c) ≥42 to 47mmol/mol (6.0%–6.4%)) and a body mass index (BMI) ≥30 kg/m2 to a DPP. Eligible patients were asked to contact Weight Watchers to book onto their DPP, an intensive lifestyle intervention which included a 90min activation session followed by the offer of 48 weekly Weight Watchers community group meetings. Patients’ blood tests were repeated by primary care, weight change plus self-reported data was recorded by Weight Watchers. Results: 166 patients were referred to the program and 149 were eligible. 79% of eligible patients attended an activation session (117 eligible patients) and 77% started the weekly sessions. The study sample was primarily female (75%), white (90%), with 5% living in the most deprived quintile in the UK. Using intention to-treat analysis, the DPP resulted in a mean reduction in HbA1c of 2.84 mmol/mol at 12 months (from 43.42±1.28 to 40.58±3.41, p<0.01). 38% of patients returned to normoglycemia and 3% developed T2D at 12 months. There was a mean weight reduction in BMI of 3.2 kg/m2 at 12 months (35.5 kg/m2 ±5.4 to 32.3 kg/ m2 ±5.2, p<0.01). Conclusion: A UK primary care referral route partnered with this commercial weight management provider can deliver an effective DPP. The lifestyle changes and weight loss achieved in the intervention translated into considerable reductions in diabetes risk, with an immediate and significant public health impact

Planning for incapacity by people with bipolar disorder under the Mental Capacity Act 2005

The Mental Capacity Act 2005 provided a variety of legal mechanisms for people to plan for periods of incapacity for decisions relating to personal care, medical treatment, and financial matters. Little research has however been done to determine the degree to which these are actually implemented, and the approach to such advance planning by service users and professionals. This paper looks at the use of advance planning by people with bipolar disorder, using qualitative and quantitative surveys both of people with bipolar disorder and psychiatrists. The study finds that the mechanisms are under-used in this group, despite official policy in support of them, largely because of a lack of knowledge about them among service users, and there is considerable confusion among service users and professionals alike as to how the mechanisms operate. Recording is at best inconsistent, raising questions as to whether the mechanisms will be followed

Use of varenicline for smoking cessation treatment in UK primary care: an association rule mining analysis

BACKGROUND: Varenicline is probably the most effective smoking cessation pharmacotherapy, but is less widely used than nicotine replacement therapy. We therefore set out to identify the characteristics of numerically important groups of patients who typically do, or do not, receive varenicline in the UK. METHODS: We used association rule mining to analyse data on prescribing of smoking cessation pharmacotherapy in relation to age, sex, comorbidity and other variables from 477,620 people aged 16 years and over, registered as patients throughout 2011 with one of 559 UK general practices in The Health Improvement Network (THIN) database, and recorded to be current smokers. RESULTS: 46,685 participants (9.8% of all current smokers) were prescribed any smoking cessation treatment during 2011, and 19,316 of these (4% of current smokers, 41% of those who received any therapy) were prescribed varenicline. Prescription of varenicline was most common among heavy smokers aged 31–60, and in those with a diagnosis of COPD. Varenicline was rarely used among smokers who were otherwise in good health, or were aged over 60, were lighter smokers, or had psychotic disorders or dementia. CONCLUSIONS: Varenicline is being underused in healthy smokers, or in older smokers, and in those with psychotic disorders or dementia. Since varenicline is probably the most effective available single cessation therapy, this study identifies under-treatment of substantial public health significance

Psychoactive prescribing for older people-what difference does 15 years make?

Objective: The objective of the study was to review prescribing of psychoactive medications for older residents of the Tayside region of Scotland. Methods: The analysis used community prescribing data in 1995 and 2010 for all older residents in Tayside. For each psychoactive drug class, the name of the most recently prescribed drug and the date prescribed were extracted. The relative risk (RR) and 95% confidence intervals (CI) for patients receiving psychoactive medication in 2010 were compared with those for patients in 1995. Psychoactive prescribing was analyzed by year, age, gender, and deprivation classification. The chi-squared test was used to calculate statistical significance. Results: Total psychoactive prescribing in people over the age of 65years has increased comparing 1995 with 2010. Antidepressant [RR=2.5 (95% CI 2.41-2.59) p&lt;0.001] and opioid analgesia [RR=1.21 (1.19-1.24) p&lt;0.001] prescriptions increased between 1995 and 2010. Hypnotics/anxiolytic [RR=0.69 (0.66-0.71) p&lt;0.001] and antipsychotic [RR=0.83 (0.77-0.88) p&lt;0.001] prescriptions decreased between 1995 and 2010. An increase in psychoactive prescribing is particularly marked in lower socioeconomic groups. Patients in the least affluent fifth of the population had RR=1.25 (1.20-1.29) [p&lt;0.001] of being prescribed one to two psychoactive medications and RR=1.81 (1.56-2.10) [p&lt;0.001] of being prescribed three or more psychoactive medications in 2010 compared with those in 1995. The RRs for the most affluent fifth were RR=1.14 (1.1-1.19) [p&lt;0.001] and RR=1.2 (1.01-1.42) [p&lt;0.001] for one to two, and three or more medications, respectively. Conclusion: Psychoactive medication prescribing has increased comparing 1995 with 2010, with increases disproportionately affecting patients in lower socioeconomic groups. The availability of new psychoactive drugs, safety concerns, and economic factors may explain these increases.</p

Access to and use of clinical services and disease-modifying therapies by people with progressive multiple sclerosis in the United Kingdom

Background: According to current UK guidelines everyone with progressive MS should have access to an MS Specialist but levels of access and use of clinical services is unknown. Our objective was to investigate access to MS Specialists, use of clinical services and disease-modifying therapies (DMTs) by people with progressive MS in the United Kingdom. Methods: A UK wide, online survey was conducted via the UK MS Register. Inclusion criteria: age over 18 years, primary or secondary progressive MS and a member of the UK MS Register. Participants were asked about access to MS Specialists; recent clinical service use; receipt of regular review and current and previous DMT use. Participant demographics; quality of life and disease impact measures were supplied from the UK MS Register. Results: In total 1298 participants responded: 5% were currently taking DMT; 23% had previously taken DMT; and 95% reported access to an MS Specialist. Most utilised services were: MS Doctor/Nurse (50%), General Practitioner (45%), and Physiotherapist (40%). Seventy-four percent received a regular review although 37% received theirs less than annually. Current DMT use was associated with better quality of life but past DMT use was associated with poorer quality of life and higher impact of disease. Conclusions: Access to, and use of, MS Specialists was high. However a gap in service provision was highlighted in both receiving and frequency of regular reviews

The Men’s Safer Sex project: intervention development and feasibility randomised controlled trial of an interactive digital intervention to increase condom use in men

Background: This report details the development of the Men’s Safer Sex website and the results of a feasibility randomised controlled trial (RCT), health economic assessment and qualitative evaluation. Objectives: (1) Develop the Men’s Safer Sex website to address barriers to condom use; (2) determine the best design for an online RCT; (3) inform the methods for collecting and analysing health economic data; (4) assess the Sexual Quality of Life (SQoL) questionnaire and European Quality of Life-5 Dimensions, three-level version (EQ-5D-3L) to calculate quality-adjusted life-years (QALYs); and (5) explore clinic staff and men’s views of online research methodology. Methods: (1) Website development: we combined evidence from research literature and the views of experts (n = 18) and male clinic users (n = 43); (2) feasibility RCT: 159 heterosexually active men were recruited from three sexual health clinics and were randomised by computer to the Men’s Safer Sex website plus usual care (n = 84) or usual clinic care only (n = 75). Men were invited to complete online questionnaires at 3, 6, 9 and 12 months, and sexually transmitted infection (STI) diagnoses were recorded from clinic notes at 12 months; (3) health economic evaluation: we investigated the impact of using different questionnaires to calculate utilities and QALYs (the EQ-5D-3L and SQoL questionnaire), and compared different methods to collect resource use; and (4) qualitative evaluation: thematic analysis of interviews with 11 male trial participants and nine clinic staff, as well as free-text comments from online outcome questionnaires. Results: (1) Software errors and clinic Wi-Fi access presented significant challenges. Response rates for online questionnaires were poor but improved with larger vouchers (from 36% with £10 to 50% with £30). Clinical records were located for 94% of participants for STI diagnoses. There were no group differences in condomless sex with female partners [incidence rate ratio (IRR) 1.01, 95% confidence interval (CI) 0.52 to 1.96]. New STI diagnoses were recorded for 8.8% (7/80) of the intervention group and 13.0% (9/69) of the control group (IRR 0.75, 95% CI 0.29 to 1.89). (2) Health-care resource data were more complete using patient files than questionnaires. The probability that the intervention is cost-effective is sensitive to the source of data used and whether or not data on intended pregnancies are included. (3) The pilot RCT fitted well around clinical activities but 37% of the intervention group did not see the Men’s Safer Sex website and technical problems were frustrating. Men’s views of the Men’s Safer Sex website and research procedures were largely positive. Conclusions: It would be feasible to conduct a large-scale RCT using clinic STI diagnoses as a primary outcome; however, technical errors and a poor response rate limited the collection of online self-reported outcomes. The next steps are (1) to optimise software for online trials, (2) to find the best ways to integrate digital health promotion with clinical services, (3) to develop more precise methods for collecting resource use data and (4) to work out how to overcome barriers to digital intervention testing and implementation in the NHS. Trial registration: Current Controlled Trials ISRCTN18649610. Funding: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 91. See the NIHR Journals Library website for further project information

Strategies for assessing renal function prior to outpatient contrast-enhanced CT: a UK survey

YesThe purpose of this paper is to identify current UK screening practices prior to contrast-enhanced CT. To determine the patient management strategies to minimize the risk of contrast-induced acute kidney injury (CI-AKI) risk in outpatients. An invitation to complete an electronic survey was distributed to the CT managers of 174 UK adult National Health Service hospital trusts. The survey included questions related to local protocols and national guidance on which these are based. Details of the assessment of renal function prior to imaging and thresholds for contrast contraindication and patient management were also sought. A response rate of 47.1% was received. Almost all sites had a policy in place for contrast administration (n = 80/82; 97.6%). The majority of sites require a blood test on outpatients undergoing a contrast-enhanced CT scan (n = 75/82; 91.5%); however, some (15/75; 20.0%) sites only check the result in patients at high risk and a small number (7/82; 8.5%) of sites indicated that it was a referrer responsibility. The estimated glomerular filtration rate (eGFR) or serum creatinine (SCr) result threshold at which i.v. contrast was contraindicated varied and 19 different threshold levels of eGFR or SCr were identified, each leading to different prophylactic strategies. Inconsistency was noted in the provision of follow-up blood tests after contrast administration. The wide variation in practice reflects inconsistencies in published guidance. Evidence-based consensuses of which patients to test and subsequent risk thresholds will aid clinicians identify those patients in which the risk of CI-AKI is clinically significant but manageable. There is also a need to determine the value of the various prophylactic strategies, follow-up regimen and efficient service delivery pathways. This survey has identified that further work is required to define which patients are high risk, confirm those which require renal function testing prior to contrast administration and how best to manage patients at risk of CI-AKI. The role of new technologies within this service delivery pathway requires further investigation

Self-management toolkit and delivery strategy for end-of-life pain: the mixed-methods feasibility study

Background: Pain affects most people approaching the end of life and can be severe for some. Opioid analgesia is effective, but evidence is needed about how best to support patients in managing these medicines. Objectives: To develop a self-management support toolkit (SMST) and delivery strategy and to test the feasibility of evaluating this intervention in a future definitive trial. Design: Phase I – evidence synthesis and qualitative interviews with patients and carers. Phase II – qualitative semistructured focus groups and interviews with patients, carers and specialist palliative care health professionals. Phase III – multicentre mixed-methods single-arm pre–post observational feasibility study. Participants: Phase I – six patients and carers. Phase II – 15 patients, four carers and 19 professionals. Phase III – 19 patients recruited to intervention that experienced pain, living at home and were treated with strong opioid analgesia. Process evaluation interviews with 13 patients, seven carers and 11 study nurses. Intervention: Self-Management of Analgesia and Related Treatments at the end of life (SMART) intervention comprising a SMST and a four-step educational delivery approach by clinical nurse specialists in palliative care over 6 weeks. Main outcome measures: Recruitment rate, treatment fidelity, treatment acceptability, patient-reported outcomes (such as scores on the Brief Pain Inventory, Self-Efficacy for Managing Chronic Disease Scale, Edmonton Symptom Assessment Scale, EuroQol-5 Dimensions, Satisfaction with Information about Medicines Scale, and feasibility of collecting data on health-care resource use for economic evaluation). Results: Phase I – key themes on supported self-management were identified from evidence synthesis and qualitative interviews. Phase II – the SMST was developed and refined. The delivery approach was nested within a nurse–patient consultation. Phase III – intervention was delivered to 17 (89%) patients, follow-up data at 6 weeks were available on 15 patients. Overall, the intervention was viewed as acceptable and valued. Descriptive analysis of patient-reported outcomes suggested that interference from pain and self-efficacy were likely to be candidates for primary outcomes in a future trial. No adverse events related to the intervention were reported. The health economic analysis suggested that SMART could be cost-effective. We identified key limitations and considerations for a future trial: improve recruitment through widening eligibility criteria, refine the SMST resources content, enhance fidelity of intervention delivery, secure research nurse support at recruiting sites, refine trial procedures (including withdrawal process and data collection frequency), and consider a cluster randomised design with nurse as cluster unit. Limitations: (1) The recruitment rate was lower than anticipated. (2) The content of the intervention was focused on strong opioids only. (3) The fidelity of intervention delivery was limited by the need for ongoing training and support. (4) Recruitment sites where clinical research nurse support was not secured had lower recruitment rates. (5) The process for recording withdrawal was not sufficiently detailed. (6) The number of follow-up visits was considered burdensome for some participants. (7) The feasibility trial did not have a control arm or assess randomisation processes. Conclusions: A future randomised controlled trial is feasible and acceptable

Gaining consensus on family carer needs when caring for someone dying at home to develop the Carers' Alert Thermometer (CAT): a modified Delphi study

Aim To report a multi-phase modified Delphi study conducted with carers and professionals to identify the priority areas for inclusion in an alert screening tool for carers providing support to someone dying at home. Background Internationally, there is a growing emphasis on increasing choice for patients who wish to die at home which relies heavily on care provided by the unpaid family carers. Family carers can have high levels of unmet needs comprising their psychological and physical health and their ability to provide effective care and support. Development of an alert tool to identify carers' needs in everyday practice required identification and consensus of the priority areas of need for inclusion. Design Multi-phase modified Delphi study and instrument development. Method Qualitative and quantitative data collection took place between 2011–2013 with 111 carers and 93 professionals to identify carers' needs and gain consensus on the priority areas for inclusion in the alert tool. An expert panel stage and final evidence review post-Delphi were used. Results The Delphi panels had high levels of agreement and consensus. Ten areas of carer need across two themes of ‘the current caring situation’ and ‘the carer's own health and well-being’ were prioritized for inclusion in the alert tool. An optional end-of-life planning question was included following the final stages. Conclusions The results provide evidence of carers' needs to be assessed, areas for consideration in the education of those who support carers and someone dying at home and targeting of services, while demonstrating the usefulness and adaptability of the Delphi method

Implementing personal health budgets in England: A user-led approach to substance misuse

Personal health budgets (PHBs) in England have been viewed as a vehicle for developing a personalised patient-based strategy within the substance misuse care pathway. In 2009, the Department of Health announced a 3-year pilot programme of PHBs to explore opportunities offered by this new initiative across a number of long-term health conditions, and commissioned an independent evaluation to run alongside as well as a separate study involving two pilot sites that were implementing PHBs within the substance misuse service. The study included a quantitative and qualitative strand. The qualitative strand involved 20 semi-structured interviews among organisational representatives at two time points (10 at each time point) between 2011 and 2012 which are the focus for this current paper. Overall, organisational representatives believed that PHBs had a positive impact on budget-holders with a drug and/or alcohol misuse problem, their families and the health and social care system. However, a number of concerns were discussed, many of which seemed to stem from the initial change management process during the early implementation stage of the pilot programme. This study provides guidance on how to implement and offer PHBs within the substance misuse care pathway: individuals potentially would benefit from receiving their PHB post-detox rather than at a crisis point; PHBs have the potential to improve the link to after-care services, and direct payments can provide greater choice and control, but sufficient protocols are required