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Cost-effectiveness of insulin pumps compared with multiple daily injections both provided with structured education for adults with type 1 diabetes: a health economic analysis of the Relative Effectiveness of Pumps over Structured Education (REPOSE) randomised controlled trial.

ABSTRACT: OBJECTIVES:To assess the long-term cost-effectiveness of insulin pumps and Dose Adjustment for Normal Eating (pumps+DAFNE) compared with multiple daily insulin injections and DAFNE (MDI+DAFNE) for adults with type 1 diabetes mellitus (T1DM) in the UK. METHODS:We undertook a cost-utility analysis using the Sheffield Type 1 Diabetes Policy Model and data from the Relative Effectiveness of Pumps over Structured Education (REPOSE) trial to estimate the lifetime incidence of diabetic complications, intervention-based resource use and associated effects on costs and quality-adjusted life years (QALYs). All economic analyses took a National Health Service and personal social services perspective and discounted costs and QALYs at 3.5% per annum. A probabilistic sensitivity analysis was performed on the base case. Further uncertainties in the cost of pumps and the evidence used to inform the model were explored using scenario analyses. SETTING:Eight diabetes centres in England and Scotland. PARTICIPANTS:Adults with T1DM who were eligible to receive a structured education course and did not have a strong clinical indication or a preference for a pump. INTERVENTION:Pumps+DAFNE. COMPARATOR:MDI+DAFNE. MAIN OUTCOME MEASURES:Incremental costs, incremental QALYs gained and incremental cost-effectiveness ratios (ICERs). RESULTS:Compared with MDI+DAFNE, pumps+DAFNE was associated with an incremental discounted lifetime cost of +£18?853 (95% CI £6175 to £31 645) and a gain in discounted lifetime QALYs of +0.13 (95% CI -0.70 to +0.96). The base case mean ICER was £142?195 per QALY gained. The probability of pump+DAFNE being cost-effective using a cost-effectiveness threshold of £20?000 per QALY gained was 14.0%. All scenario and subgroup analyses examined indicated that the ICER was unlikely to fall below £30?000 per QALY gained. CONCLUSIONS:Our analysis of the REPOSE data suggests that routine use of pumps in adults without an immediate clinical need for a pump, as identified by National Institute for Health and Care Excellence, would not be cost-effective. TRIAL REGISTRATION NUMBER:ISRCTN61215213.

SUBMITTER: Pollard DJ

PROVIDER: S-EPMC5893943 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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Cost-effectiveness of insulin pumps compared with multiple daily injections both provided with structured education for adults with type 1 diabetes: a health economic analysis of the Relative Effectiveness of Pumps over Structured Education (REPOSE) randomised controlled trial.

Pollard Daniel John DJ Brennan Alan A Dixon Simon S Waugh Norman N Elliott Jackie J Heller Simon S Lee Ellen E Campbell Michael M Basarir Hasan H White David D

BMJ open 20180407 4

<h4>Objectives</h4>To assess the long-term cost-effectiveness of insulin pumps and Dose Adjustment for Normal Eating (pumps+DAFNE) compared with multiple daily insulin injections and DAFNE (MDI+DAFNE) for adults with type 1 diabetes mellitus (T1DM) in the UK.<h4>Methods</h4>We undertook a cost-utility analysis using the Sheffield Type 1 Diabetes Policy Model and data from the Relative Effectiveness of Pumps over Structured Education (REPOSE) trial to estimate the lifetime incidence of diabetic c ...[more]

PMID: 29627802

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Project description:IntroductionPeople with type 1 diabetes (T1DM) require insulin therapy to sustain life, and need optimal glycaemic control to prevent diabetic ketoacidosis and serious long-term complications. Insulin is generally administered using multiple daily injections but can also be delivered using an infusion pump (continuous subcutaneous insulin infusion), a more costly option with benefits for some patients. The UK National Institute for Health and Care Excellence (NICE) recommend the use of pumps for patients with the greatest need, citing insufficient evidence to approve extension to a wider population. Far fewer UK adults use pumps than in comparable countries. Previous trials of pump therapy have been small and of short duration and failed to control for training in insulin adjustment. This paper describes the protocol for a large randomised controlled trial comparing pump therapy with multiple daily injections, where both groups are provided with high-quality structured education.Methods and analysisA multicentre, parallel group, cluster randomised controlled trial among 280 adults with T1DM. All participants attended the week-long dose adjustment for normal eating (DAFNE) structured education course, and receive either multiple daily injections or pump therapy for 2?years. The trial incorporates a detailed mixed-methods psychosocial evaluation and cost-effectiveness analysis. The primary outcome will be the change in glycosylated haemoglobin (HbA1c) at 24?months in those participants whose baseline HbA1c is at or above 7.5% (58?mmol/mol). The key secondary outcome will be the proportion of participants reaching the NICE target of an HbA1c of 7.5% (58?mmol/mol) or less at 24?months.Ethics and disseminationThe protocol was approved by the Research Ethics Committee North West, Liverpool East and received Medicines and Healthcare products Regulatory Agency (MHRA) clinical trials authorisation. Each participating centre gave National Health Service R&D approval. We shall disseminate study findings to study participants and through peer reviewed publications and conference presentations, including lay user groups.Trial registration numberISRCTN 61215213.

Project description:BACKGROUND:Adolescence is a critical period of human development, however, limited research on programs to improve health and well-being among younger adolescents living in conflict-affected and humanitarian settings exists. The purpose of this study was to assess the comparative effectiveness of an economic empowerment program on young adolescent outcomes in a complex humanitarian setting. METHODS:This longitudinal, mixed methods study examined the relative effectiveness of an integrated parent (Pigs for Peace, PFP) and young adolescent (Rabbits for Resilience, RFR) animal microfinance/asset transfer program (RFR + PFP) on adolescent outcomes of asset building, school attendance, mental health, experienced stigma, and food security compared to RFR only and PFP only over 24 months. A sub-sample of young adolescents completed in-depth qualitative interviews on the benefits and challenges of participating in RFR. RESULTS:Five hundred forty-two young adolescents (10-15 years) participated in three groups: RFR + PFP (N = 178), RFR only (N = 187), PFP only (N = 177). 501 (92.4%) completed baseline surveys, with 81.7% (n = 442) retention at endline. The group by time interaction (24 months) was significant for adolescent asset building (X2 = 16.54, p = .002), school attendance (X2 = 12.33, p = .015), and prosocial behavior (X2 = 10.56, p = .032). RFR + PFP (ES = 0.31, ES = 0.38) and RFR only (ES-0.39, ES = 0.14) adolescents had greater improvement in asset building and prosocial behavior compared to PFP only, respectively. The odds of missing two or more days of school in the past month were 78.4% lower in RFR only and 45.1% lower in RFR + PFP compared to PFP only. No differences between groups in change over time were found for internalizing behaviors, experienced stigma, or food security. Differences by age and gender were observed in asset building, prosocial behavior, school attendance, experienced stigma, and food security. The voices of young adolescents identified the benefits of the RFR program through their ability to pay for school fees, help their families meet basic needs, and the respect they gained from family and community. Challenges included death of rabbits and potential conflict within the household on how to use the rabbit asset. CONCLUSION:These findings underscore the potential for integrating economic empowerment programs with both parents and young adolescents to improve economic, educational, and health outcomes for young adolescents growing up in rural and complex humanitarian settings. TRIAL REGISTRATION:NCT02008695. Retrospectively registered 11 December 2013.

Project description:ObjectivesTo apply sociological theories to understand public trust in extended services provided by community pharmacists relative to those provided by general practitioners (GPs).DesignQualitative study involving focus groups with members of the public.SettingThe West of Scotland.Participants26 purposively sampled members of the public were involved in one of five focus groups. The groups were composed to represent known groups of users and non-users of community pharmacy, namely mothers with young children, seniors and men.ResultsTrust was seen as being crucial in healthcare settings. Focus group discussions revealed that participants were inclined to draw unfavourable comparisons between pharmacists and GPs. Importantly, participants' trust in GPs was greater than that in pharmacists. Participants considered pharmacists to be primarily involved in medicine supply, and awareness of the pharmacist's extended role was low. Participants were often reluctant to trust pharmacists to deliver unfamiliar services, particularly those perceived to be 'high risk'. Numerous system-based factors were identified, which reinforce patient trust and confidence in GPs, including GP registration and appointment systems, GPs' expert/gatekeeper role and practice environments. Our data indicate that the nature and context of public interactions with GPs fostered familiarity with a specific GP or practice, which allowed interpersonal trust to develop. By contrast, participants' exposure to community pharmacists was limited. Additionally, a good understanding of the GPs' level of training and role promoted confidence.ConclusionCurrent UK initiatives, which aim to implement a range of pharmacist-led services, are undermined by lack of public trust. It seems improbable that the public will trust pharmacists to deliver unfamiliar services, which are perceived to be 'high risk', unless health systems change in a way that promotes trust in pharmacists. This may be achieved by increasing the quality and quantity of patient interactions with pharmacists and gaining GP support for extended pharmacy services.

Project description:BackgroundIn high-resource settings, structured diabetes self-management education is associated with improved outcomes but the evidence from low-resource settings is limited and inconclusive.AimTo compare, structured diabetes self-management education to usual care, in adults with type 2 diabetes, in low-resource settings.Research design and methodsDesignSingle-blind randomised parallel comparator controlled multi-centre trial. Adults (> 18 years) with type 2 diabetes from two hospitals in urban Ghana were randomised 1:1 to usual care only, or usual care plus a structured diabetes self-management education program. Randomisation codes were computer-generated, and allotment concealed in opaque numbered envelopes. The intervention effect was assessed with linear mixed models.Main outcomeChange in HbA1c after 3-month follow-up. Primary analysis involved all participants.Clinicaltrialgov identifier:NCT04780425, retrospectively registered on 03/03/2021.ResultsRecruitment: 22nd until 29th January 2021. We randomised 206 participants (69% female, median age 58 years [IQR: 49-64], baseline HbA1c median 64 mmol/mol [IQR: 45-88 mmol/mol],7.9%[IQR: 6.4-10.2]). Primary outcome data was available for 79 and 80 participants in the intervention and control groups, respectively. Reasons for loss to follow-up were death (n = 1), stroke(n = 1) and unreachable or unavailable (n = 47). A reduction in HbA1c was found in both groups; -9 mmol/mol [95% CI: -13 to -5 mmol/mol], -0·9% [95% CI: -1·2% to -0·51%] in the intervention group and -3 mmol/mol [95% CI -6 to 1 mmol/mol], -0·3% [95% CI: -0·6% to 0.0%] in the control group. The intervention effect was 1 mmol/mol [95%CI:-5 TO 8 p = 0.726]; 0.1% [95% CI: -0.5, 0.7], p = 0·724], adjusted for site, age, and duration of diabetes. No significant harms were observed.ConclusionIn low-resource settings, diabetes self-management education might not be associated with glycaemic control. Clinician's expectations from diabetes self-management education must therefore be guarded.

Dataset Information

Cost-effectiveness of insulin pumps compared with multiple daily injections both provided with structured education for adults with type 1 diabetes: a health economic analysis of the Relative Effectiveness of Pumps over Structured Education (REPOSE) randomised controlled trial.

Publications

Cost-effectiveness of insulin pumps compared with multiple daily injections both provided with structured education for adults with type 1 diabetes: a health economic analysis of the Relative Effectiveness of Pumps over Structured Education (REPOSE) randomised controlled trial.

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