Cost-Effectiveness of Facilitated Access to a Self-Management Website, Compared to Usual Care, for Patients With Type 2 Diabetes (HeLP-Diabetes): Randomized Controlled Trial

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Abstract

Background

Type 2 diabetes mellitus is one of the most common long-term conditions, and costs health services approximately 10% of their total budget. Active self-management by patients improves outcomes and reduces health service costs. While the existing evidence suggested that uptake of self-management education was low, the development of internet-based technology might improve the situation.

Objective

To establish the cost-effectiveness of a Web-based self-management program for people with type 2 diabetes (HeLP-Diabetes) compared to usual care.

Methods

An incremental cost-effectiveness analysis was conducted, from a National Health Service and personal and social services perspective, based on data collected from a multi-center, two-arm individually randomized controlled trial over 12 months. Adults aged 18 or over with a diagnosis of type 2 diabetes and registered with the 21 participating general practices (primary care) in England, UK, were approached. People who were unable to provide informed consent or to use the intervention, terminally ill, or currently participating in a trial of an alternative self-management intervention, were excluded. The participants were then randomized to either usual care plus HeLP-Diabetes, an interactive, theoretically-informed Web-based self-management program, or to usual care plus access to a comparator website containing basic information only. The participants’ intervention costs and wider health care resource use were collected as well as two health-related quality of life measures: the Problem Areas in Diabetes (PAID) Scale and EQ-5D-3L. EQ-5D-3L was then used to calculate quality-adjusted life years (QALYs). The primary analysis was based on intention-to-treat, using multiple imputation to handle the missing data.

Results

In total, 374 participants were randomized, with 185 in the intervention group and 189 in the control group. The primary analysis showed incremental cost-effectiveness ratios of £58 (95% CI –411 to 587) per unit improvement on PAID scale and £5550 (95% CI –21,077 to 52,356) per QALY gained by HeLP-Diabetes, compared to the control. The complete case analysis showed less cost-effectiveness and higher uncertainty with incremental cost-effectiveness ratios of £116 (95% CI –1299 to 1690) per unit improvement on PAID scale and £18,500 (95% CI –203,949 to 190,267) per QALY. The cost-effectiveness acceptability curve showed an 87% probability of cost-effectiveness at £20,000 per QALY willingness-to-pay threshold. The one-way sensitivity analyses estimated 363 users would be needed to use the intervention for it to become less costly than usual care.

Conclusions

Facilitated access to HeLP-Diabetes is cost-effective, compared to usual care, under the recommended threshold of £20,000 to £30,000 per QALY by National Institute of Health and Care Excellence.

Trial Registration

International Standard Randomized Controlled Trial Number (ISRCTN) 02123133; http://www.controlled-trials.com/ISRCTN02123133 (Archived by WebCite at http://www.webcitation.org/6zqjhmn00)

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Most cited references 37

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Worldwide trends in diabetes since 1980: a pooled analysis of 751 population-based studies with 4·4 million participants

Emily Sonestedt (2016)

Summary Background One of the global targets for non-communicable diseases is to halt, by 2025, the rise in the age-standardised adult prevalence of diabetes at its 2010 levels. We aimed to estimate worldwide trends in diabetes, how likely it is for countries to achieve the global target, and how changes in prevalence, together with population growth and ageing, are affecting the number of adults with diabetes. Methods We pooled data from population-based studies that had collected data on diabetes through measurement of its biomarkers. We used a Bayesian hierarchical model to estimate trends in diabetes prevalence—defined as fasting plasma glucose of 7·0 mmol/L or higher, or history of diagnosis with diabetes, or use of insulin or oral hypoglycaemic drugs—in 200 countries and territories in 21 regions, by sex and from 1980 to 2014. We also calculated the posterior probability of meeting the global diabetes target if post-2000 trends continue. Findings We used data from 751 studies including 4 372 000 adults from 146 of the 200 countries we make estimates for. Global age-standardised diabetes prevalence increased from 4·3% (95% credible interval 2·4–7·0) in 1980 to 9·0% (7·2–11·1) in 2014 in men, and from 5·0% (2·9–7·9) to 7·9% (6·4–9·7) in women. The number of adults with diabetes in the world increased from 108 million in 1980 to 422 million in 2014 (28·5% due to the rise in prevalence, 39·7% due to population growth and ageing, and 31·8% due to interaction of these two factors). Age-standardised adult diabetes prevalence in 2014 was lowest in northwestern Europe, and highest in Polynesia and Micronesia, at nearly 25%, followed by Melanesia and the Middle East and north Africa. Between 1980 and 2014 there was little change in age-standardised diabetes prevalence in adult women in continental western Europe, although crude prevalence rose because of ageing of the population. By contrast, age-standardised adult prevalence rose by 15 percentage points in men and women in Polynesia and Micronesia. In 2014, American Samoa had the highest national prevalence of diabetes (>30% in both sexes), with age-standardised adult prevalence also higher than 25% in some other islands in Polynesia and Micronesia. If post-2000 trends continue, the probability of meeting the global target of halting the rise in the prevalence of diabetes by 2025 at the 2010 level worldwide is lower than 1% for men and is 1% for women. Only nine countries for men and 29 countries for women, mostly in western Europe, have a 50% or higher probability of meeting the global target. Interpretation Since 1980, age-standardised diabetes prevalence in adults has increased, or at best remained unchanged, in every country. Together with population growth and ageing, this rise has led to a near quadrupling of the number of adults with diabetes worldwide. The burden of diabetes, both in terms of prevalence and number of adults affected, has increased faster in low-income and middle-income countries than in high-income countries. Funding Wellcome Trust.

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A literature review on the representativeness of randomized controlled trial samples and implications for the external validity of trial results

Tessa Kennedy-Martin, Sarah E Curtis, Douglas E Faries … (2015)

Randomized controlled trials (RCTs) are conducted under idealized and rigorously controlled conditions that may compromise their external validity. A literature review was conducted of published English language articles that reported the findings of studies assessing external validity by a comparison of the patient sample included in RCTs reporting on pharmaceutical interventions with patients from everyday clinical practice. The review focused on publications in the fields of cardiology, mental health, and oncology. A range of databases were interrogated (MEDLINE; EMBASE; Science Citation Index; Cochrane Methodology Register). Double-abstract review and data extraction were performed as per protocol specifications. Out of 5,456 de-duplicated abstracts, 52 studies met the inclusion criteria (cardiology, n = 20; mental health, n = 17; oncology, n = 15). Studies either performed an analysis of the baseline characteristics (demographic, socioeconomic, and clinical parameters) of RCT-enrolled patients compared with a real-world population, or assessed the proportion of real-world patients who would have been eligible for RCT inclusion following the application of RCT inclusion/exclusion criteria. Many of the included studies concluded that RCT samples are highly selected and have a lower risk profile than real-world populations, with the frequent exclusion of elderly patients and patients with co-morbidities. Calculation of ineligibility rates in individual studies showed that a high proportion of the general disease population was often excluded from trials. The majority of studies (n = 37 [71.2 %]) explicitly concluded that RCT samples were not broadly representative of real-world patients and that this may limit the external validity of the RCT. Authors made a number of recommendations to improve external validity. Findings from this review indicate that there is a need to improve the external validity of RCTs such that physicians treating patients in real-world settings have the appropriate evidence on which to base their clinical decisions. This goal could be achieved by trial design modification to include a more representative patient sample and by supplementing RCT evidence with data generated from observational studies. In general, a thoughtful approach to clinical evidence generation is required in which the trade-offs between internal and external validity are considered in a holistic and balanced manner. Electronic supplementary material The online version of this article (doi:10.1186/s13063-015-1023-4) contains supplementary material, which is available to authorized users.

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Assessment of diabetes-related distress.

Ivan Anderson, David C. Schwartz, William H. Polonsky … (1995)

To describe a new measure of psychosocial adjustment specific to diabetes, the Problem Areas in Diabetes Survey (PAID), and to present initial information on its reliability and validity. Before their routine clinic appointments, 451 female patients with type I and type II diabetes, all of whom required insulin, completed a self-report survey. Included in the survey was the PAID, a 20-item questionnaire in which each item represents a unique area of diabetes-related psychosocial distress. Each item is rated on a six-point Likert scale, reflecting the degree to which the item is perceived as currently problematic. A total scale score, hypothesized to reflect the overall level of diabetes-related emotional distress, is computed by summing the total item responses. To examine the concurrent validity of the PAID, the survey also included a series of standardized questionnaires assessing psychosocial functioning (general emotional distress, fear of hypoglycemia, and disordered eating), attitudes toward diabetes, and self-care behaviors. All subjects were assessed for HbA1, within 30 days of survey completion and again approximately 1-2 years later. Finally, long-term diabetic complications were determined through chart review. Internal reliability of the PAID was high, with good item-to-total correlations. Approximately 60% of the subject sample reported at least one serious diabetes-related concern. As expected, the PAID was positively associated with relevant psychosocial measures of distress, including general emotional distress, disordered eating, and fear of hypoglycemia, short- and long-term diabetic complications, and HbA1, and negatively associated with reported self-care behaviors. The PAID accounted for approximately 9% of the variance in HbA1. Diabetes-related emotional distress, as measured by the PAID, was found to be a unique contributor to adherence to self-care behaviors after adjustment for age, diabetes duration, and general emotional distress. In addition, the PAID was associated with HbA1 even after adjustment for age, diabetes duration, general emotional distress, and adherence to self-care behaviors. These findings suggest that the PAID, a brief, easy-to-administer instrument, may be valuable in assessing psychosocial adjustment to diabetes. In addition to high internal reliability, the consistent pattern of correlational findings indicates that the PAID is tapping into relevant aspects of emotional distress and that its particular feature, the measurement of diabetes-related emotional distress, is uniquely associated with diabetes-relevant outcomes. These data are also consistent with the hypothesis that diabetes-related emotional distress, separate from general emotional distress, is an independent and major contributor to poor adherence. Given that the study was limited to female patients using insulin, further examination of the clinical usefulness of the PAID will need to focus on more heterogeneous samples.

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Author and article information

Contributors

Elizabeth Murray:

Research Department of Primary Care and Population HealthUniversity College LondonLondon, NW3 2PFUnited Kingdom44 2077940500 ext 3882644 2077941224elizabeth.murray@ucl.ac.uk

ORCID: http://orcid.org/0000-0002-8932-3695

Journal

Journal ID (nlm-ta): J Med Internet Res

Journal ID (iso-abbrev): J. Med. Internet Res

Journal ID (publisher-id): JMIR

Title: Journal of Medical Internet Research

Publisher: JMIR Publications (Toronto, Canada )

ISSN (Print): 1439-4456

ISSN (Electronic): 1438-8871

Publication date Collection: June 2018

Publication date (Electronic): 08 June 2018

Volume: 20

Issue: 6

Electronic Location Identifier: e201

Affiliations

[1] ¹ Mental Health and Addiction Research Group Department of Health sciences University of York York United Kingdom

[2] ² Cardiovascular Epidemiology Unit Department of Public Health and Primary Care University of Cambridge Cambridge United Kingdom

[3] ³ Nuffield Department of Primary Care Health Sciences University of Oxford Oxford United Kingdom

[4] ⁴ Research Department of Primary Care and Population Health University College London London United Kingdom

[5] ⁵ Department of Psychology University of Bath Bath United Kingdom

[6] ⁶ Department of Psychology University of Southampton Southampton United Kingdom

[7] ⁷ Department of Diabetes & Endocrinology Whittington Health NHS Trust London United Kingdom

[8] ⁸ Population Health Research Institute St. George’s University of London London United Kingdom

[9] ⁹ Community Health Sciences Department College of Applied Medical Sciences King Saud University Riyadh Saudi Arabia

Author notes

Corresponding Author: Elizabeth Murray elizabeth.murray@ 123456ucl.ac.uk

Author information

Jinshuo Li http://orcid.org/0000-0003-1496-7450

Steve Parrott http://orcid.org/0000-0002-0165-1150

Michael Sweeting http://orcid.org/0000-0003-0980-8965

Andrew Farmer http://orcid.org/0000-0002-6170-4402

Jamie Ross http://orcid.org/0000-0001-8720-5911

Charlotte Dack http://orcid.org/0000-0002-5124-094X

Kingshuk Pal http://orcid.org/0000-0001-6630-6684

Lucy Yardley http://orcid.org/0000-0002-3853-883X

Maria Barnard http://orcid.org/0000-0003-1643-2644

Mohammed Hudda http://orcid.org/0000-0001-7894-1159

Ghadah Alkhaldi http://orcid.org/0000-0001-9041-4546

Elizabeth Murray http://orcid.org/0000-0002-8932-3695

Article

Publisher ID: v20i6e201

DOI: 10.2196/jmir.9256

PMC ID: 6015272

PubMed ID: 29884608

SO-VID: aed33548-9b17-46d6-9ef2-9279401ba712

Copyright © ©Jinshuo Li, Steve Parrott, Michael Sweeting, Andrew Farmer, Jamie Ross, Charlotte Dack, Kingshuk Pal, Lucy Yardley, Maria Barnard, Mohammed Hudda, Ghadah Alkhaldi, Elizabeth Murray. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 08.06.2018.

License:

This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in the Journal of Medical Internet Research, is properly cited. The complete bibliographic information, a link to the original publication on http://www.jmir.org/, as well as this copyright and license information must be included.

History

Date received : 25 November 2017

Date revision requested : 1 February 2018

Date revision received : 6 March 2018

Date accepted : 3 April 2018

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