Scrutinized Proof of Effectiveness or Cost Effectiveness Regarding Patient Reported Outcomes

2016 ◽  
pp. 295-326
Author(s):  
Thomas Wetter
Keyword(s):  
Cost Effectiveness ◽  
Patient Reported Outcomes ◽  
Patient Reported

scholarly journals The clinical effectiveness and cost-effectiveness of second-eye cataract surgery: a systematic review and economic evaluation

2014 ◽  
Vol 18 (68) ◽  
pp. 1-206 ◽  
Author(s):  
Geoff Frampton ◽  
Petra Harris ◽  
Keith Cooper ◽  
Andrew Lotery ◽  
Jonathan Shepherd
Keyword(s):  
Quality Of Life ◽  
Systematic Review ◽  
Cost Effectiveness ◽  
Cataract Surgery ◽  
Patient Reported Outcomes ◽  
Clinical Effectiveness ◽  
Cost Effective ◽  
Eye Surgery ◽  
Patient Reported

BackgroundElective cataract surgery is the most commonly performed surgical procedure in the NHS. In bilateral cataracts, the eye with greatest vision impairment from cataract is operated on first. First-eye surgery can improve vision and quality of life. However, it is unclear whether or not cataract surgery on the second eye provides enough incremental benefit to be considered clinically effective and cost-effective.ObjectiveTo conduct a systematic review of clinical effectiveness and analysis of cost-effectiveness of second-eye cataract surgery in England and Wales, based on an economic model informed by systematic reviews of cost-effectiveness and quality of life.Data sourcesTwelve electronic bibliographic databases, including MEDLINE, EMBASE, Web of Science, The Cochrane Library and the Centre for Reviews and Dissemination databases were searched from database inception to April 2013, with searches updated in July 2013. Reference lists of relevant publications were also checked and experts consulted.Review methodsTwo reviewers independently screened references, extracted and checked data from the included studies and appraised their risk of bias. Based on the review of cost-effectiveness, a de novo economic model was developed to estimate the cost-effectiveness of second-eye surgery in bilateral cataract patients. The model is based on changes in quality of life following second-eye surgery and includes post-surgical complications.ResultsThree randomised controlled trials (RCTs) of clinical effectiveness, three studies of cost-effectiveness and 10 studies of health-related quality of life (HRQoL) met the inclusion criteria for the systematic reviews and, where possible, were used to inform the economic analysis. Heterogeneity of studies precluded meta-analyses, and instead data were synthesised narratively. The RCTs assessed visual acuity, contrast sensitivity, stereopsis and several measures of HRQoL. Improvements in binocular visual acuity and contrast sensitivity were small and unlikely to be of clinical significance, but stereopsis was improved to a clinically meaningful extent following second-eye surgery. Studies did not provide evidence that second-eye surgery significantly affected HRQoL, apart from an improvement in the mental health component of HRQoL in one RCT. In the model, second-eye surgery generated 0.68 incremental quality-adjusted life-years with an incremental cost-effectiveness ratio of £1964. Model results were most sensitive to changes in the utility gain associated with second-eye surgery, but otherwise robust to changes in parameter values. The probability that second-eye surgery is cost-effective at willingness-to-pay thresholds of £10,000 and £20,000 is 100%.LimitationsClinical effectiveness studies were all conducted more than 9 years ago. Patients had good vision pre surgery which may not represent all patients eligible for second-eye surgery. For some vision-related patient-reported outcomes and HRQoL measures, thresholds for determining important clinical effects are either unclear or have not been determined.ConclusionsSecond-eye cataract surgery is generally cost-effective based on the best available data and under most assumptions. However, more up-to-date data are needed. A well-conducted RCT that reflects current populations and enables the estimation of health state utility values would be appropriate. Guidance is required on which vision-related, patient-reported outcomes are suitable for assessing effects of cataract surgery in the NHS and how these measures should be interpreted clinically.Study registrationThis project is registered as PROSPERO CRD42013004211.FundingThis project was funded by the National Institute for Health Research Health Technology Assessment programme.

scholarly journals Strategies to reduce the use of low-value medical tests in primary care: a systematic review

2020 ◽  
Vol 70 (701) ◽  
pp. e858-e865
Author(s):  
Toshihiko Takada ◽  
Pauline Heus ◽  
Sander van Doorn ◽  
Christiana A Naaktgeboren ◽  
Jan-Willem Weenink ◽  
...  
Keyword(s):  
Systematic Review ◽  
Primary Care ◽  
Cost Effectiveness ◽  
Adverse Events ◽  
Patient Reported Outcomes ◽  
Targeted Interventions ◽  
Primary Care Settings ◽  
Medical Tests ◽  
Patient Reported ◽  
Randomised Controlled

BackgroundIt is recognised that medical tests are overused in primary care; however, it is unclear how best to reduce their use.AimTo identify which strategies are effective in reducing the use of low-value medical tests in primary care settings.Design and settingSystematic review.MethodThe databases MEDLINE, EMBASE, and Rx for Change were searched (January 1990 to November 2019) for randomised controlled trials (RCTs) that evaluated strategies to reduce the use of low-value medical tests in primary care settings. Two reviewers selected eligible RCTs, extracted data, and assessed their risk of bias.ResultsOf the 16 RCTs included in the review, 11 reported a statistically significant reduction in the use of low-value medical tests. The median of the differences between the relative reductions in the intervention and control arms was 17% (interquartile range 12% to 24%). Strategies using reminders or audit/feedback showed larger reduction than those without these components (22% versus 14%, and 22% versus 13%, respectively) and patient-targeted strategies showed larger reductions than those not targeted at patients (51% versus 17%). Very few studies investigated the sustainability of the effect, adverse events, cost-effectiveness, or patient-reported outcomes related to reducing the use of low-value tests.ConclusionThis review indicates that it is possible to reduce the use of low-value medical tests in primary care, especially by using multiple components including reminders, audit/feedback, and patient-targeted interventions. To implement these strategies widely in primary care settings, more research is needed not only to investigate their effectiveness, but also to examine adverse events, cost-effectiveness, and patient-reported outcomes.

Cost-Effectiveness Comparison of Three Methods of Internal Fixation for Arthrodesis of the First Metatarsophalangeal Joint

1998 ◽  
Vol 19 (5) ◽  
pp. 304-310 ◽  
Author(s):  
Anthony D. Watson ◽  
Armen S. Kelikian
Keyword(s):  
Cost Effectiveness ◽  
Average Cost ◽  
Patient Reported Outcomes ◽  
Metatarsophalangeal Joint ◽  
Cost Effective ◽  
Fixation Device ◽  
Union Rate ◽  
First Metatarsophalangeal Joint ◽  
Patient Reported

We used decision-analysis modeling to determine the most cost-effective fixation device among Herbert screws, AO screws, and the Luhr plate for first metatarsophalangeal joint arthrodesis. The model considered patient-reported outcomes at minimum 2-year follow-up, patient charges for the entire course of care, and event and outcome incidences within each fixation group. AO screws had the lowest average cost of utility and, therefore, are the most cost-effective fixation device for first metatarsophalangeal joint arthrodesis even though utility is highest with the Luhr plate. Operating room costs and union rate most strongly influenced cost-effectiveness.

MO812THE COMPARISON OF HIGH-DOSE HAEMODIAFILTRATION WITH HIGH-FLUX HAEMODIALYSIS (CONVINCE) STUDY: BASELINE CHARACTERISTICS AND PROOF OF PRINCIPLE OF THE CONVECTION VOLUME DELIVERED

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
Robin Vernooij ◽  
Mei-Man Lee ◽  
Mark Woodward ◽  
Jörgen Hegbrant ◽  
Bernard Canaud ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Patient Reported Outcomes ◽  
European Countries ◽  
High Dose ◽  
High Flux ◽  
Treatment Characteristics ◽  
Dialysis Vintage ◽  
Patient Reported ◽  
The Mean ◽  
Baseline Characteristics

Abstract Background and Aims Although high-dose haemodiafiltration (HDF) has shown some promising survival advantage compared with high-flux haemodialysis (HD), the evidence remains controversial. In view of these discrepant results, a definitive trial is required to determine whether high-dose HDF is superior to high-flux HD. The comparison of high-dose HDF with high-flux HD (CONVINCE) study will assess the benefits and harms of high-dose HDF versus conventional high-flux HD in adults with end-stage kidney disease (ESKD). Here we provide information on the baseline characteristics of the included patients and evaluate whether the patients randomised to HDF were able to reach a high-dose convection volume. Method This international, prospective, open label, randomised, controlled trial is aiming to recruit 1800 ESKD adults treated with high-flux HD in 9 European countries. Patients will be randomised 1:1 to high-dose HDF versus continuation of conventional high-flux HD. High-dose HDF is defined as a convection volume per session of ≥23 L (range ±1 L). The trial is designed with a follow-up time for each patient of at least 24 months and will assess all-cause mortality, cause-specific mortality, cardiovascular events, hospitalisation, patient-reported outcomes, and cost-effectiveness. For this study we tabulated the baseline characteristics for all randomised participants by treatment groups. For the patients randomised to HDF, we calculated the proportion of the patients reaching a convection volume of ≥ 23L. session on the first visit after baseline (i.e. 3 months) and compared baseline and treatment characteristics with the patients with a convection volume of <23L/session. Results CONVINCE has recruited, until the start of January 2021, 1139 patients in eight European countries. The mean age was 62.4 (SD: 13.2) years and 62% (n=709) patients were men. The mean dialysis vintage was 5.0 (6.1) years. The mean systolic blood pressure (BP) was 141 (22) mmHg, the diastolic BP was 73 (14) mmHg, and the body mass index (BMI) was 27.6 (5.7) kg/m2. Approximately one-third the patients had diabetes mellitus and 21% had a history of coronary heart disease at baseline. Of the patients randomised to HDF, over 85% achieved a convection volume of ≥23L/session. There were no apparent differences in baseline and treatment characteristics between the patients who reached a convective volume of ≥23L/session versus those who did not: the vascular access was, respectively, a fistula (82% vs 81%), catheter (13% vs 14%), and graft (5% vs 5%) access. Conclusion The CONVINCE study will run up to 2023 and addresses the question of benefits and harms, regarding survival, hospitalisation, patient-reported outcomes, and cost-effectiveness of high-dose HDF compared with high-flux HD in patients with ESKD. This first analysis shows that achievement of high-dose HDF is feasible for most patients and, most importantly, could be maintained during the present trial period.

scholarly journals Multicomponent hospital-led interventions to reduce hospital stay for older adults following elective surgery: a systematic review

2019 ◽  
Vol 7 (40) ◽  
pp. 1-178 ◽  
Author(s):  
Michael Nunns ◽  
Liz Shaw ◽  
Simon Briscoe ◽  
Jo Thompson Coon ◽  
Anthony Hemsley ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Colorectal Surgery ◽  
Hospital Stay ◽  
Randomised Controlled Trials ◽  
Patient Reported Outcomes ◽  
Enhanced Recovery ◽  
Controlled Trials ◽  
Patient Reported ◽  
Randomised Controlled ◽  
The Uk

Background Elective older adult inpatient admissions are increasingly common. Older adults are at an elevated risk of adverse events in hospital, potentially increasing with lengthier hospital stay. Hospital-led organisational strategies may optimise hospital stay for elective older adult inpatients. Objectives To evaluate the effectiveness and cost-effectiveness of hospital-led multicomponent interventions to reduce hospital stay for older adults undergoing elective hospital admissions. Data sources Seven bibliographic databases (MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, EMBASE, Health Management Information Consortium, Cochrane Central Register of Controlled Trials, Cumulative Index to Nursing and Allied Health Literature and Allied and Complementary Medicine Database) were searched from inception to date of search (August 2017), alongside carrying out of web searches, citation searching, inspecting relevant reviews, consulting stakeholders and contacting authors. This search was duplicated, with an additional cost-filter, to identify cost-effectiveness evidence. Review methods Comparative studies were sought that evaluated the effectiveness or cost-effectiveness of relevant interventions in elective inpatients with a mean or median age of ≥ 60 years. Study selection, data extraction and quality assessment were completed independently by two reviewers. The main outcome was length of stay, but all outcomes were considered. Studies were sorted by procedure, intervention and outcome categories. Where possible, standardised mean differences or odds ratios were calculated. Meta-analysis was performed when multiple randomised controlled trials had the same intervention, treatment procedure, comparator and outcome. Findings were explored using narrative synthesis. Findings A total of 218 articles were included, with 80 articles from 73 effectiveness studies (n = 26,365 patients) prioritised for synthesis, including 34 randomised controlled trials conducted outside the UK and 39 studies from the UK, of which 12 were randomised controlled trials. Fifteen studies included cost-effectiveness data. The evidence was dominated by enhanced recovery protocols and prehabilitation, implemented to improve recovery from either colorectal surgery or lower limb arthroplasty. Six other surgical categories and four other intervention types were identified. Meta-analysis found that enhanced recovery protocols were associated with 1.5 days’ reduction in hospital stay among patients undergoing colorectal surgery (Cohen’s d = –0.51, 95% confidence interval –0.78 to –0.24; p < 0.001) and with 5 days’ reduction among those undergoing upper abdominal surgery (Cohen’s d = –1.04, 95% confidence interval –1.55 to –0.53; p < 0.001). Evidence from the UK was not pooled (owing to mixed study designs), but it echoed findings from the international literature. Length of stay usually was reduced with intervention or was no different. Other clinical outcomes also improved or were no worse with intervention. Patient-reported outcomes were not frequently reported. Cost and cost-effectiveness evidence came from 15 highly heterogeneous studies and was less conclusive. Limitations Studies were usually of moderate or weak quality. Some intervention or treatment types were under-reported or absent. The reporting of variance data often precluded secondary analysis. Conclusions Enhanced recovery and prehabilitation interventions were associated with reduced hospital stay without detriment to other clinical outcomes, particularly for patients undergoing colorectal surgery, lower limb arthroplasty or upper abdominal surgery. The impacts on patient-reported outcomes, health-care costs or additional service use are not well known. Future work Further studies evaluating of the effectiveness of new enhanced recovery pathways are not required in colorectal surgery or lower limb arthroplasty. However, the applicability of these pathways to other procedures is uncertain. Future studies should evaluate the implementation of interventions to reduce service variation, in-hospital patient-reported outcomes, impacts on health and social care service use, and longer-term patient-reported outcomes. Study registration This study is registered as PROSPERO CRD42017080637. Funding The National Institute for Health Research Health Services and Delivery Research programme.

scholarly journals Protocol for a national cohort study to explore the long-term clinical and patient-reported outcomes and cost-effectiveness of implant-based and autologous breast reconstruction after mastectomy for breast cancer: the brighter study

BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e054055
Author(s):  
Leigh Johnson ◽  
Chris Holcombe ◽  
Joe M O’Donoghue ◽  
Ranjeet Jeevan ◽  
John Browne ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cost Effectiveness ◽  
Patient Reported Outcomes ◽  
Advisory Group ◽  
Autologous Reconstruction ◽  
Economic Modelling ◽  
Long Term Outcomes ◽  
High Quality ◽  
Patient Reported

IntroductionBreast reconstruction (BR) is offered to improve quality of life for women with breast cancer undergoing mastectomy. As most women will be long-term breast cancer survivors, high-quality information regarding the long-term outcomes of different BR procedures is essential to support informed decision-making. As different techniques vary considerably in cost, policymakers also require high-quality cost-effectiveness evidence to inform care. The Brighter study aims to explore the long-term clinical and patient-reported outcomes (PROs) of implant-based and autologous BR and use health economic modelling to compare the long-term cost-effectiveness of different reconstructive techniques.Methods and analysisWomen undergoing mastectomy and/or BR following a diagnosis of breast cancer between 1 January 2008 and 31 March 2009 will be identified from hospital episode statistics (HES). Surviving women will be contacted and invited to complete validated PRO measures including the BREAST-Q, EQ-5D-5L and ICECAP-A, or opt out of having their data included in the HES analysis. Long-term clinical outcomes will be explored using HES data. The primary outcome will be rates of revisional surgery between implant-based and autologous procedures. Secondary outcomes will include rates of secondary reconstruction and reconstruction failure. The long-term PROs of implant-based and autologous reconstruction will be compared using BREAST-Q, EQ-5D-5L and ICECAP-A scores. Multivariable regression will be used to examine the relationship between long-term outcomes, patient comorbidities, sociodemographic and treatment factors. A Markov model will be developed using HES and PRO data and published literature to compare the relative long-term cost-effectiveness of implant-based and autologous BR.Ethics and disseminationThe Brighter study has been approved by the South-West -Central Bristol Research Ethics Committee (20/SW/0020), and the Confidentiality Advisory Group (20/CAG/0021). Results will be published in peer-reviewed journals and presented at national meetings. We will work with the professional associations, charities and patient groups to disseminate the results.

scholarly journals Evaluation of a shared decision-making strategy with online decision aids in surgical and orthopaedic practice: study protocol for the E-valuAID, a multicentre study with a stepped-wedge design

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Floris M. Thunnissen ◽  
Bernhard W. Schreurs ◽  
Carmen S. S. Latenstein ◽  
Marjan J. Meinders ◽  
Eddy M. Adang ◽  
...  
Keyword(s):  
Inguinal Hernia ◽  
Cost Effectiveness ◽  
Patient Reported Outcomes ◽  
Decision Aids ◽  
Hip Osteoarthritis ◽  
Treatment Decision ◽  
Stepped Wedge ◽  
Orthopaedic Practice ◽  
Patient Reported ◽  
Surgery Rates

Abstract Background Inguinal hernia repair, gallbladder removal, and knee- and hip replacements are the most commonly performed surgical procedures, but all are subject to practice variation and variable patient-reported outcomes. Shared decision-making (SDM) has the potential to reduce surgery rates and increase patient satisfaction. This study aims to evaluate the effectiveness of an SDM strategy with online decision aids for surgical and orthopaedic practice in terms of impact on surgery rates, patient-reported outcomes, and cost-effectiveness. Methods The E-valuAID-study is designed as a multicentre, non-randomized stepped-wedge study in patients with an inguinal hernia, gallstones, knee or hip osteoarthritis in six surgical and six orthopaedic departments. The primary outcome is the surgery rate before and after implementation of the SDM strategy. Secondary outcomes are patient-reported outcomes and cost-effectiveness. Patients in the usual care cluster prior to implementation of the SDM strategy will be treated in accordance with the best available clinical evidence, physician’s knowledge and preference and the patient’s preference. The intervention consists of the implementation of the SDM strategy and provision of disease-specific online decision aids. Decision aids will be provided to the patients before the consultation in which treatment decision is made. During this consultation, treatment preferences are discussed, and the final treatment decision is confirmed. Surgery rates will be extracted from hospital files. Secondary outcomes will be evaluated using questionnaires, at baseline, 3 and 6 months. Discussion The E-valuAID-study will examine the cost-effectiveness of an SDM strategy with online decision aids in patients with an inguinal hernia, gallstones, knee or hip osteoarthritis. This study will show whether decision aids reduce operation rates while improving patient-reported outcomes. We hypothesize that the SDM strategy will lead to lower surgery rates, better patient-reported outcomes, and be cost-effective. Trial registration: The Netherlands Trial Register, Trial NL8318, registered 22 January 2020. URL: https://www.trialregister.nl/trial/8318.

scholarly journals The CAST study protocol: a cluster randomized trial assessing the effect of circumferential casting versus plaster splinting on fracture redisplacement in reduced distal radius fractures in adults

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Britt Barvelink ◽  
◽  
Max Reijman ◽  
Niels W. L. Schep ◽  
Vanessa Brown ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Distal Radius ◽  
Closed Reduction ◽  
Patient Reported Outcomes ◽  
Distal Radius Fractures ◽  
Adult Patients ◽  
Primary Study ◽  
Radius Fractures ◽  
Patient Reported ◽  
Cluster Randomized

Abstract Background There is no consensus concerning the optimal casting technique for displaced distal radius fractures (DRFs) following closed reduction. This study evaluates whether a splint or a circumferential cast is most optimal to prevent fracture redisplacement in adult patients with a reduced DRF. Additionally, the cost-effectiveness of both cast types will be calculated. Methods/design This multicenter cluster randomized controlled trial will compare initial immobilization with a circumferential below-elbow cast versus a below-elbow plaster splint in reduced DRFs. Randomization will take place on hospital-level (cluster, n = 10) with a cross-over point halfway the inclusion of the needed number of patients per hospital. Inclusion criteria comprise adult patients (≥ 18 years) with a primary displaced DRF which is treated conservatively after closed reduction. Multiple trauma patients (Injury Severity Score ≥ 16), concomitant ulnar fractures (except styloid process fractures) and patients with concomitant injury on the ipsilateral arm or inability to complete study forms will be excluded. Primary study outcome is fracture redisplacement of the initial reduced DRF. Secondary outcomes are patient-reported outcomes assessed with the Disability Arm Shoulder Hand score (DASH) and Patient-Rated Wrist Evaluation score (PRWE), comfort of the cast, quality of life assessed with the EQ-5D-5L questionnaire, analgesics use, cost-effectiveness and (serious) adverse events occurence. In total, 560 patients will be included and followed for 1 year. The estimated time required for inclusion will be 18 months. Discussion The CAST study will provide evidence whether the type of cast immobilization is of influence on fracture redisplacement in distal radius fractures. Extensive follow-up during one year concerning radiographic, functional and patient reported outcomes will give a broad view on DRF recovery. Trial registration Registered in the Dutch Trial Registry on January 14th 2020. Registration number: NL8311.

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