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Ready-made and custom-made eyeglasses in India: a cost-effectiveness analysis of a randomised controlled trial.

ABSTRACT: Objective:Ready-made spectacles have been suggested as a less resource-intensive treatment for the millions of people living with uncorrected refractive error (URE) in low-income environments. In spite of this interest, there have been no published economic evaluations examining the cost-effectiveness of ready-made spectacles. This study aims to determine the relative cost-effectiveness of offering ready-made spectacles (RMS) relative to no intervention as well as the relative cost-effectiveness of custom-made spectacles (CS) relative to RMS to treat URE. Methods and analysis:The relative cost-effectiveness of RMS relative to CS and no intervention was tested through a cost-effectiveness analysis from the health service provider perspective conducted alongside a double-masked randomised controlled trial in an urban hospital in Delhi, India. Participants were adults aged 18-45 years with ?1?dioptre (D) of URE. Results:There was no significant difference between the effectiveness of the CS and RMS interventions in improving visual acuity, but the CS was over four times the price of the RMS per patient (204 INR (US$2.42) and 792 INR (US$11.22)). The cost per unit improvement in logarithm of the minimum angle of resolution (logMAR) relative to baseline with the RMS intervention was 407 INR (US$4.35). Existing estimates of utility resulting from improvements in visual acuity result in incremental cost per quality-adjusted life years gained of between 212 INR and 1137 INR (US$0.44-US$23.74) depending on the source of the utility estimate and assumed expected life of the spectacles. Conclusion:RMS represent a significantly cost-effective option for spectacle provision in low-resource settings. The RMS programme was substantially cheaper than an equivalent CS intervention while being effective in improving visual acuity for the majority of adults with refractive error in this setting. These findings provide further support for including RMS in programmes to address URE. Trial registration number:NCT00657670, Results.

SUBMITTER: Angell B

PROVIDER: S-EPMC5895972 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Ready-made and custom-made eyeglasses in India: a cost-effectiveness analysis of a randomised controlled trial.

Angell Blake B Ali Ferhina F Gandhi Monica M Mathur Umang U Friedman David S DS Jan Stephen S Keay Lisa L

BMJ open ophthalmology 20180209 1

<h4>Objective</h4>Ready-made spectacles have been suggested as a less resource-intensive treatment for the millions of people living with uncorrected refractive error (URE) in low-income environments. In spite of this interest, there have been no published economic evaluations examining the cost-effectiveness of ready-made spectacles. This study aims to determine the relative cost-effectiveness of offering ready-made spectacles (RMS) relative to no intervention as well as the relative cost-effec ...[more]

PMID: 29657979

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Project description:ObjectivesTo evaluate the cost-effectiveness of custom-made insoles compared with general practitioner (GP)-led usual care after 26 weeks of follow-up in individuals with plantar heel pain (PHP) from a societal perspective.DesignCost-effectiveness analysis of a double-blinded randomised controlled trial.SettingGeneral practice in the Netherlands.Participants116 participants with PHP for at least 2 weeks, aged 18-65 years and presenting to the GP.InterventionsParticipants were randomised to GP-led usual care (n=46) or referral to a podiatrist for treatment with a custom-made insole (n=70). Participant randomised to a sham insole (n=69) were excluded from this analysis.Primary and secondary outcomesOutcomes comprised pain during rest and activity, and quality of life. Costs included healthcare and lost productivity costs. Statistical uncertainty was estimated using bootstrapping and presented using cost-effectiveness acceptability curves.ResultsParticipants in the custom-made insole group experienced statistically significant more pain during activity at 26 weeks than participants in the usual care group (overall effect 1.06; 95% CI 0.36 to 1.75). There were no significant differences between groups in other outcomes. Total societal costs in the custom-made insole group were non-significantly higher than in the usual care group (mean difference €376; 95% CI -€1775 to €2038). The intervention with custom-made insoles was dominated by usual care by the GP (ie, more expensive and less effective) for pain during activity and quality of life outcomes. For the outcome pain at rest, the intervention was more expensive and more effective than usual care. However, the maximum probability of cost-effectiveness was only 0.59 at very high ceiling ratios.ConclusionsThese findings show that that custom-made insoles are not cost-effective in comparison with GP-led usual care. Clinicians should be reserved in prescribing custom-made insoles for PHP as a primary intervention.Trial registration numberNTR5346.

Project description:Importance:Uncorrected refractive errors are the most common cause of visual impairment in children despite correction being highly cost-effective. Objective:To determine whether less expensive ready-made spectacles produce rates of spectacle wear at 3 to 4 months comparable to those of more expensive custom-made spectacles among eligible school-aged children. Design, Setting, and Participants:This noninferiority, double-masked, randomized clinical trial recruited children aged 11 to 15 years from January 12 through July 31, 2015, from government schools in urban and periurban areas surrounding Bangalore, India. Follow-up occurred from August 1 through September 31, 2015. Participants met the following eligibility criteria for ready-made spectacles: failed vision screening at the 6/9 level in each eye; refraction was indicated; acuity improved with correction by 2 or more lines in the better-seeing eye; the corrected acuity with the spherical equivalent was not more than 1 line less than with full correction; anisometropia measured less than 1.0 diopter; and an appropriate frame was available. Interventions:Eligible children were randomized to ready-made or custom-made spectacles. Main Outcomes and Measures:Proportion of children wearing their spectacles at unannounced visits 3 to 4 months after the intervention. Results:Of 23?345 children aged 11 to 15 years who underwent screening, 694 had visual acuity of less than 6/9 in both eyes, and 535 underwent assessment for eligibility. A total of 460 children (227 female [49.3%] and 233 male [50.7%]; mean [SD] age, 13.4 [1.3] years) were eligible for ready-made spectacles (2.0% undergoing screening and 86.0% undergoing assessment) and were randomized to ready-made (n?=?232) or custom-made (n?=?228) spectacles. Follow-up rates at 3 to 4 months were similar (184 [79.3%] in the ready-made group and 178 [78.1%] in the custom-made group). Rates of spectacle wear in the 2 arms were similar among 139 of 184 children (75.5%) in the ready-made arm and 131 of 178 children (73.6%) in the custom-made arm (risk difference, 1.8%; 95% CI, -7.1% to 10.8%). Conclusions and Relevance:Most children were eligible for ready-made spectacles, and the proportion wearing ready-made spectacles was not inferior to the proportion wearing custom-made spectacles at 3 to 4 months. These findings suggest that ready-made spectacles could substantially reduce costs for school-based eye health programs in India without compromising spectacle wear, at least in the short term. Trial Registration:isrctn.com Identifier: ISRCTN14715120.

Project description:BackgroundA three-arm parallel group, randomised controlled trial set in general dental practices in England, Scotland, and Wales was undertaken to evaluate three strategies to manage dental caries in primary teeth. Children, with at least one primary molar with caries into dentine, were randomised to receive Conventional with best practice prevention (C?+?P), Biological with best practice prevention (B?+?P), or best practice Prevention Alone (PA).MethodsData on costs were collected via case report forms completed by clinical staff at every visit. The co-primary outcomes were incidence of, and number of episodes of, dental pain and/or infection avoided. The three strategies were ranked in order of mean cost and a more costly strategy was compared with a less costly strategy in terms of incremental cost-effectiveness. Costs and outcomes were discounted at 3.5%.ResultsA total of 1144 children were randomised with data on 1058 children (C?+?P n?=?352, B?+?P n?=?352, PA n?=?354) used in the analysis. On average, it costs £230 to manage dental caries in primary teeth over a period of up to 36?months. Managing children in PA was, on average, £19 (97.5% CI: -£18 to £55) less costly than managing those in B?+?P. In terms of effectiveness, on average, there were fewer incidences of, (-?0.06; 97.5% CI: -?0.14 to 0.02) and fewer episodes of dental pain and/or infection (-?0.14; 97.5% CI: -?0.29 to 0.71) in B?+?P compared to PA. C?+?P was unlikely to be considered cost-effective, as it was more costly and less effective than B?+?P.ConclusionsThe mean cost of a child avoiding any dental pain and/or infection (incidence) was £330 and the mean cost per episode of dental pain and/or infection avoided was £130. At these thresholds B?+?P has the highest probability of being considered cost-effective. Over the willingness to pay thresholds considered, the probability of B?+?P being considered cost-effective never exceeded 75%.Trial registrationThe trial was prospectively registered with the ISRCTN (reference number ISRCTN77044005) on the 26th January 2009 and East of Scotland Research Ethics Committee provided ethical approved (REC reference: 12/ES/0047).

Project description:We sought to evaluate visual performance and satisfaction with ready-made spectacles (RMS) in Chinese school-aged children with uncorrected refractive error.Randomized, double-blind, clinical trial.Junior high school students from urban Guangzhou, China, aged approximately 12 to 15 years with > or =1 diopter (D) of uncorrected spherical equivalent (SE) refractive error. Students were excluded with > or =2.00 D astigmatism, > or =2 D myopic anisometropia, and > or =1 D hyperopic anisometropia and ocular disease affecting vision.Refractive error was determined by cycloplegic subjective refraction. Students were randomly assigned to receive RMS or custom spectacles (CS) and assessed after 1 month of use. We required 175 students to complete in each arm to be able to measure a 15% difference in compliance.Compliance with spectacles lens wear, patterns of use, vision, symptoms, and perceived value.Screening identified 965 of 4607 (20.9%) students with reduced distance vision; 212 of the 965 (22.0%) refused evaluation and 187 of the 965 (20.8%) had <1 D of SE refractive error. Sixty-one (6.3%) were referred for further evaluation and the remaining 495 (51.3%) participated. Social, demographic, and ocular parameters were similar in the 2 groups. Average SE refractive error was -2.57+/-1.31 (mean value +/- standard deviation [SD]). Spectacle vision (Snellen acuity, mean +/- SD) was worse with RMS in the eye with lower SE (20/25(-0.5)+/-0.9 lines vs 20/25(+1)+/-0.7 lines; P = 0.004) and higher SE (20/25(-2)+/-1.2 lines vs 20/25(+1)+/-0.8; P<0.001). There were no differences (P>0.05) in the rate of use (94.3% vs 92.2%), wearing to the 1-month visit (46.9% vs 51.5%), planned use (93.3% vs 93.7%), value (89.5% vs 91.7% "moderate or high value or most valued possession"), or symptoms (blur, 21.1% vs 19.4% [P = 0.8] and other symptoms [P>0.2]).Although visual acuity was better with CS, no difference was found in acceptability in this population of students with predominantly simple myopic refractive error. This study supports the use of RMS in a school-based refractive services program, saving costs and improving the logistics of service delivery.

Project description:Alcoholic hepatitis (AH) is a distinct presentation of alcoholic liver disease arising in patients who have been drinking to excess for prolonged periods, which is characterised by jaundice and liver failure. Severe disease is associated with high short-term mortality. Prednisolone and pentoxifylline (PTX) are recommended in guidelines for treatment of severe AH, but trials supporting their use have given heterogeneous results and controversy persists about their benefit.The aim of the clinical effectiveness and cost-effectiveness of STeroids Or Pentoxifylline for Alcoholic Hepatitis trial was to resolve the clinical dilemma on the use of prednisolone or PTX.The trial was a randomised, double-blind, 2 × 2 factorial, multicentre design.Sixty-five gastroenterology and hepatology inpatient units across the UK.Patients with a clinical diagnosis of AH who had a Maddrey's discriminant function value of ≥ 32 were randomised into four arms: A, placebo/placebo; B, placebo/prednisolone; C, PTX/placebo; and D, PTX/prednisolone. Of the 5234 patients screened for the trial, 1103 were randomised and after withdrawals, 1053 were available for primary end-point analysis.Those allocated to prednisolone were given 40 mg daily for 28 days and those allocated to PTX were given 400 mg three times per day for 28 days.The primary outcome measure was mortality at 28 days. Secondary outcome measures included mortality or liver transplant at 90 days and at 1 year. Rates of recidivism among survivors and the impact of recidivism on mortality were assessed.At 28 days, in arm A, 45 of 269 (16.7%) patients died; in arm B, 38 of 266 (14.3%) died; in arm C, 50 of 258 (19.4%) died; and in arm D, 35 of 260 (13.5%) died. For PTX, the odds ratio for 28-day mortality was 1.07 [95% confidence interval (CI) 0.77 to 1.40; p = 0.686)] and for prednisolone the odds ratio was 0.72 (95% CI 0.52 to 1.01; p = 0.056). In the logistic regression analysis, accounting for indices of disease severity and prognosis, the odds ratio for 28-day mortality in the prednisolone-treated group was 0.61 (95% CI 0.41 to 0.91; p = 0.015). At 90 days and 1 year there were no significant differences in mortality rates between the treatment groups. Serious infections occurred in 13% of patients treated with prednisolone compared with 7% of controls (p = 0.002). At the 90-day follow-up, 45% of patients reported being completely abstinent, 9% reported drinking within safety limits and 33% had an unknown level of alcohol consumption. At 1 year, 37% of patients reported being completely abstinent, 10% reported drinking within safety limits and 39% had an unknown level of alcohol consumption. Only 22% of patients had attended alcohol rehabilitation treatment at 90 days and 1 year.We conclude that prednisolone reduces the risk of mortality at 28 days, but this benefit is not sustained beyond 28 days. PTX had no impact on survival. Future research should focus on interventions to promote abstinence and on treatments that suppress the hepatic inflammation without increasing susceptibility to infection.This trial is registered as EudraCT 2009-013897-42 and Current Controlled Trials ISRCTN88782125.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. 19, No. 102. See the NIHR Journals Library website for further project information. The NIHR Clinical Research Network provided research nurse support and the Imperial College Biomedical Research Centre also provided funding.

Project description:IntroductionRobotic-assisted knee replacement systems have been introduced to healthcare services worldwide in an effort to improve clinical outcomes for people, although high-quality evidence that they are clinically, or cost-effective remains sparse. Robotic-arm systems may improve surgical accuracy and could contribute to reduced pain, improved function and lower overall cost of total knee replacement (TKR) surgery. However, TKR with conventional instruments may be just as effective and may be quicker and cheaper. There is a need for a robust evaluation of this technology, including cost-effectiveness analyses using both within-trial and modelling approaches. This trial will compare robotic-assisted against conventional TKR to provide high-quality evidence on whether robotic-assisted knee replacement is beneficial to patients and cost-effective for healthcare systems.Methods and analysisThe Robotic Arthroplasty Clinical and cost Effectiveness Randomised controlled trial-Knee is a multicentre, participant-assessor blinded, randomised controlled trial to evaluate the clinical and cost-effectiveness of robotic-assisted TKR compared with TKR using conventional instruments. A total of 332 participants will be randomised (1:1) to provide 90% power for a 12-point difference in the primary outcome measure; the Forgotten Joint Score at 12 months postrandomisation. Allocation concealment will be achieved using computer-based randomisation performed on the day of surgery and methods for blinding will include sham incisions for marker clusters and blinded operation notes. The primary analysis will adhere to the intention-to-treat principle. Results will be reported in line with the Consolidated Standards of Reporting Trials statement. A parallel study will collect data on the learning effects associated with robotic-arm systems.Ethics and disseminationThe trial has been approved by an ethics committee for patient participation (East Midlands-Nottingham 2 Research Ethics Committee, 29 July 2020. NRES number: 20/EM/0159). All results from the study will be disseminated using peer-reviewed publications, presentations at international conferences, lay summaries and social media as appropriate.Trial registration numberISRCTN27624068.

Project description:BackgroundIn contrast to evidence for interventions supporting victim/survivors of domestic violence and abuse (DVA), the effectiveness of perpetrator programmes for reduction of abuse is uncertain. This study aims to estimate the effectiveness and cost-effectiveness of a perpetrator programme for men.MethodsPragmatic two-group individually randomised controlled trial (RCT) with embedded process and economic evaluation. Five centres in southwest England and South Wales aim to recruit 316 (reduced from original target of 366) male domestic abuse perpetrators. These will be randomised 2:1 to a community-based domestic abuse perpetrator programme (DAPP) or usual care comparator with 12-month follow-up. Female partners/ex-partners will be invited to join the study. The intervention for men comprises 23 weekly sessions of a group programme delivered in voluntary sector domestic abuse services. The intervention for female partners/ex-partners is one-to-one support from a safety worker. Men allocated to usual care receive no intervention; however, they are free to access other services. Their partners/ex-partners will be signposted to support services. Data is collected at baseline, and 4, 8 and 12 months' follow-up. The primary outcome is men's self-reported abusive behaviour measured by the Abusive Behaviour Inventory (ABI-29) at 12 months. Secondary measures include physical and mental health status and resource use alongside the abuse measure ABI (ABI-R) for partners/ex-partners and criminal justice contact for men. A mixed methods process evaluation and qualitative study will explore mechanisms of effectiveness, judge fidelity to the intervention model using interviews and group observations. The economic evaluation, over a 1-year time horizon from three perspectives (health and social care, public sector and society), will employ a cost-consequences framework reporting costs alongside economic outcomes (Quality-Adjusted Life Years derived from EQ-5D-5L, SF-12 and CHU-9D, and ICECAP-A) as well as the primary and other secondary outcomes.DiscussionThis trial will provide evidence of the (cost)effectiveness of a DAPP. The embedded process evaluation will further insights in the experiences and contexts of participants and their journey through a perpetrator programme, and the study will seek to address the omission in other studies of economic evaluations.Trial registrationISRCTN15804282, April 1, 2019.

Dataset Information

Ready-made and custom-made eyeglasses in India: a cost-effectiveness analysis of a randomised controlled trial.

Publications

Ready-made and custom-made eyeglasses in India: a cost-effectiveness analysis of a randomised controlled trial.

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