Dataset Information

Cost-Effectiveness of Haemorrhoidal Artery Ligation versus Rubber Band Ligation for the Treatment of Grade II-III Haemorrhoids: Analysis Using Evidence from the HubBLe Trial.

ABSTRACT: Haemorrhoids are a common condition, with nearly 30,000 procedures carried out in England in 2014/15, and result in a significant quality-of-life burden to patients and a financial burden to the healthcare system. This study examined the cost effectiveness of haemorrhoidal artery ligation (HAL) compared with rubber band ligation (RBL) in the treatment of grade II-III haemorrhoids.This analyses used data from the HubBLe study, a multicentre, open-label, parallel group, randomised controlled trial conducted in 17 acute UK hospitals between September 2012 and August 2015. A full economic evaluation, including long-term cost effectiveness, was conducted from the UK National Health Service (NHS) perspective. Main outcomes included healthcare costs, quality-adjusted life-years (QALYs) and recurrence. Cost-effectiveness results were presented in terms of incremental cost per QALY gained and cost per recurrence avoided. Extrapolation analysis for 3 years beyond the trial follow-up, two subgroup analyses (by grade of haemorrhoids and recurrence following RBL at baseline), and various sensitivity analyses were undertaken.In the primary base-case within-trial analysis, the incremental total mean cost per patient for HAL compared with RBL was £1027 (95% confidence interval [CI] £782-£1272, p < 0.001). The incremental QALYs were 0.01 QALYs (95% CI -0.02 to 0.04, p = 0.49). This generated an incremental cost-effectiveness ratio (ICER) of £104,427 per QALY. In the extrapolation analysis, the estimated probabilistic ICER was £21,798 per QALY. Results from all subgroup and sensitivity analyses did not materially change the base-case result.Under all assessed scenarios, the HAL procedure was not cost effective compared with RBL for the treatment of grade II-III haemorrhoids at a cost-effectiveness threshold of £20,000 per QALY; therefore, economically, its use in the NHS should be questioned.

SUBMITTER: Alshreef A

PROVIDER: S-EPMC5691841 | biostudies-other | 2017 Sep

REPOSITORIES: biostudies-other

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Cost-Effectiveness of Haemorrhoidal Artery Ligation versus Rubber Band Ligation for the Treatment of Grade II-III Haemorrhoids: Analysis Using Evidence from the HubBLe Trial.

Alshreef Abualbishr A Wailoo Allan J AJ Brown Steven R SR Tiernan James P JP Watson Angus J M AJM Biggs Katie K Bradburn Mike M Hind Daniel D

PharmacoEconomics - open 20170901 3

<h4>Aim</h4>Haemorrhoids are a common condition, with nearly 30,000 procedures carried out in England in 2014/15, and result in a significant quality-of-life burden to patients and a financial burden to the healthcare system. This study examined the cost effectiveness of haemorrhoidal artery ligation (HAL) compared with rubber band ligation (RBL) in the treatment of grade II-III haemorrhoids.<h4>Method</h4>This analyses used data from the HubBLe study, a multicentre, open-label, parallel group, ...[more]

PMID: 29441497

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Project description:Introduction Haemorrhoidal disease is one of the most common anorectal disorders, which affects nearly half of the general population. Treatment of grade III haemorrhoids consists initially of conservative measures, followed by rubber band ligation and haemorrhoidectomy when unsuccessful. Given the current guidelines and numerous modalities the obvious question which needs to be answered is which treatment is the best for grade III haemorrhoids. There is a need for evaluating treatment from the patient’s point of view and transparency in surgical and non-surgical treatment outcome. Methods and analysis This multicentre, randomised controlled, non-inferiority trial with cost–utility analysis compares haemorrhoidectomy with rubber band ligation. Patients aged 18 years and older with symptomatic haemorrhoids grade III are recruited. Primary outcome measure is quality of life at 24 months measured with the EQ-5D-5L and in-hospital (in)direct costs and out-of-hospital postoperative costs. A key secondary outcome is recurrence at 1-year postprocedure. Secondary outcomes are complaint reduction with proctology-specific patient-reported outcome measurements (Haemorrhoid Severity Score, ProctoPROM, PROM-HISS, vaizey score), resumption of work, pain and complication rates. Data are collected at seven different time points. Standard postprocedural care is followed. A sample size has been calculated using a one sided alpha of 0.025 and a power of 80% with an SD of 0.15 and a non-inferiority limit of 0.05. With stratification by centre and to adjust for 10% lost to follow-up the total sample size will be 360 patients in total (180 per group). Data will be analysed according to the intention-to-treat and the per-protocol principle. Ethics and dissemination The protocol has been approved by the Medical Ethics Review Committee of the Amsterdam University Medical Centres, location AMC. Findings will be disseminated in peer-reviewed journals and presented at conferences, whether they are positive, negative or inconclusive. Trial registration numbers NCT04621695, NTR8020

Project description:BackgroundOptimum surgical intervention for low-grade haemorrhoids is unknown. Haemorrhoidal artery ligation (HAL) has been proposed as an efficacious, safe therapy while rubber band ligation (RBL) is a commonly used outpatient treatment. We compared recurrence after HAL versus RBL in patients with grade II-III haemorrhoids.MethodsThis multicentre, open-label, parallel group, randomised controlled trial included patients from 17 acute UK NHS trusts. We screened patients aged 18 years or older presenting with grade II-III haemorrhoids. We excluded patients who had previously received any haemorrhoid surgery, more than one injection treatment for haemorrhoids, or more than one RBL procedure within 3 years before recruitment. Eligible patients were randomly assigned (in a 1:1 ratio) to either RBL or HAL with Doppler. Randomisation was computer-generated and stratified by centre with blocks of random sizes. Allocation concealment was achieved using a web-based system. The study was open-label with no masking of participants, clinicians, or research staff. The primary outcome was recurrence at 1 year, derived from the patient's self-reported assessment in combination with resource use from their general practitioner and hospital records. Recurrence was analysed in patients who had undergone one of the interventions and been followed up for at least 1 year. This study is registered with the ISRCTN registry, ISRCTN41394716.FindingsFrom Sept 9, 2012, to May 6, 2014, of 969 patients screened, 185 were randomly assigned to the HAL group and 187 to the RBL group. Of these participants, 337 had primary outcome data (176 in the RBL group and 161 in the HAL group). At 1 year post-procedure, 87 (49%) of 176 patients in the RBL group and 48 (30%) of 161 patients in the HAL group had haemorrhoid recurrence (adjusted odds ratio [aOR] 2·23, 95% CI 1·42-3·51; p=0·0005). The main reason for this difference was the number of extra procedures required to achieve improvement (57 [32%] participants in the RBL group and 23 [14%] participants in the HAL group had a subsequent procedure for haemorrhoids). The mean pain 1 day after procedure was 3·4 (SD 2·8) in the RBL group and 4·6 (2·8) in the HAL group (difference -1·2, 95% CI -1·8 to -0·5; p=0·0002); at day 7 the scores were 1·6 (2·3) in the RBL group and 3·1 (2·4) in the HAL group (difference -1·5, -2·0 to -1·0; p<0·0001). Pain scores did not differ between groups at 21 days and 6 weeks. 15 individuals reported serious adverse events requiring hospital admission. One patient in the RBL group had a pre-existing rectal tumour. Of the remaining 14 serious adverse events, 12 (7%) were among participants treated with HAL and two (1%) were in those treated with RBL. Six patients had pain (one treated with RBL, five treated with HAL), three had bleeding not requiring transfusion (one treated with RBL, two treated with HAL), two in the HAL group had urinary retention, two in the HAL group had vasovagal upset, and one in the HAL group had possible sepsis (treated with antibiotics).InterpretationAlthough recurrence after HAL was lower than a single RBL, HAL was more painful than RBL. The difference in recurrence was due to the need for repeat bandings in the RBL group. Patients (and health commissioners) might prefer such a course of RBL to the more invasive HAL.FundingNIHR Health Technology Assessment programme.

Project description:ObjectiveThe Cardiothoracic Surgical Trials Network reported that left ventricular reverse remodeling at 2 years did not differ between patients with moderate ischemic mitral regurgitation randomized to coronary artery bypass grafting plus mitral valve repair (n = 150) or coronary artery bypass grafting alone (n = 151). To address health resource use implications, we compared costs and quality-adjusted survival.MethodsWe used individual patient data from the Cardiothoracic Surgical Trials Network trial on survival, hospitalizations, quality of life, and US hospitalization costs to estimate cumulative costs and quality-adjusted life years. A microsimulation model was developed to extrapolate to 10 years. Bootstrap and deterministic sensitivity analyses were performed to address uncertainty.ResultsIn-hospital costs were $59,745 for coronary artery bypass grafting plus mitral valve repair versus $51,326 for coronary artery bypass grafting alone (difference $8419; 95% uncertainty interval, 2259-18,757). Two-year costs were $81,263 versus $67,341 (difference 13,922 [2370 to 28,888]), and quality-adjusted life years were 1.35 versus 1.30 (difference 0.05; -0.04 to 0.14), resulting in an incremental cost-effectiveness ratio of $308,343/quality-adjusted life year for coronary artery bypass grafting plus mitral valve repair. At 10 years, its costs remained higher ($107,733 vs $88,583, difference 19,150 [-3866 to 56,826]) and quality-adjusted life years showed no difference (-0.92 to 0.87), with 5.08 versus 5.08. The likelihood that coronary artery bypass grafting plus mitral valve repair would be considered cost-effective at 10 years based on a cost-effectiveness threshold of $100K/quality-adjusted life year did not exceed 37%. Only when this procedure reduces the death rate by a relative 5% will the incremental cost-effectiveness ratio fall below $100K/quality-adjusted life year.ConclusionsThe addition of mitral valve repair to coronary artery bypass grafting for patients with moderate ischemic mitral regurgitation is unlikely to be cost-effective. Only if late mortality benefits can be demonstrated will it meet commonly used cost-effectiveness criteria.

Project description:Fatigue is a common yet difficult to treat condition in primary care. The objective of this study is to evaluate the cost-effectiveness of a brief cognitive behavioral therapy (CBT) based fatigue self-management (FSM) intervention as compared to usual care among patients with chronic fatigue in primary care.An economic evaluation alongside of a parallel randomized controlled study design was used. Computer-generated variable-sized block randomization plan was used to assign patients into treatment groups and data collection staff were blinded to group assignments. Patients aged between 18 and 65 years with at least six months of persistent fatigue and no medical or psychiatric exclusions were enrolled from a large primary care practice in Stony Brook, New York. The FSM group (n = 37) received two sessions of a nurse-delivered, fatigue self-management protocol and a self-help book and the usual care group (n = 36) received regular medical care. The effectiveness measure was the Fatigue Severity Scale and the cost measure was total health care expenditures derived from monthly health services use diaries during follow-up. A societal perspective was adopted and bootstrapped incremental cost-effectiveness ratios (ICERs) and net monetary benefit (NMB) were calculated as measures of cost-effectiveness.The ICER for FSM was -$$2358, indicating that FSM dominates UC and it may generate societal cost savings as compared to usual care. Complete case analysis yielded smaller ICER (-$1199) with greater uncertainties. Net monetary benefit analysis showed that FSM has a probability of 0.833 (95% CI: 0.819, 0.847) to achieve positive NMB and the favorable results were not sensitive to assumptions about informal care or treatment costs.This economic evaluation found initial evidence that a two-session brief CBT-based FSM may be cost-effective as compared to usual care over 12 months. The FSM intervention is potentially a promising intervention for chronic fatigue patients in primary care. Additional research is needed to examine the reproducibility and generalizability of these findings.ClinicalTrials.gov (NCT00997451, March 28, 2009).

Dataset Information

Cost-Effectiveness of Haemorrhoidal Artery Ligation versus Rubber Band Ligation for the Treatment of Grade II-III Haemorrhoids: Analysis Using Evidence from the HubBLe Trial.

Publications

Cost-Effectiveness of Haemorrhoidal Artery Ligation versus Rubber Band Ligation for the Treatment of Grade II-III Haemorrhoids: Analysis Using Evidence from the HubBLe Trial.

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