Publications by authors named "W Hollingworth"

268 Publications

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 08 18;11(8):e054055. Epub 2021 Aug 18.

Bristol Centre for Surgical Research, Population Health Sciences, Bristol Medical School, Bristol, UK

Introduction: Breast 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 Analysis: Women 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 Dissemination: The 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.
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http://dx.doi.org/10.1136/bmjopen-2021-054055DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8375757PMC
August 2021

A semi-Markov model comparing the lifetime cost-effectiveness of mesh prophylaxis to prevent parastomal hernia in patients undergoing end colostomy creation for rectal cancer.

Colorectal Dis 2021 Jul 31. Epub 2021 Jul 31.

Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.

Aim: Parastomal hernia (PSH) is a common problem following colostomy. Using prophylactic mesh during end colostomy creation may reduce PSH incidence, but concerns exist regarding the optimal type of mesh, potential long-term complications, and cost-effectiveness of its use. We evaluated the cost-effectiveness of mesh prophylaxis to prevent PSH in patients undergoing end colostomy creation for rectal cancer.

Methods: We developed a decision-analytical model, stratified by rectal cancer stages I-IV, to estimate the lifetime costs, quality-adjusted life-years (QALYs) and net monetary benefits (NMBs) of synthetic, biologic and no mesh from a UK NHS perspective. We pooled the mesh-related relative risks of PSH from 13 randomised controlled trials (RCTs) and superimposed these on the baseline (no mesh) risk from a population-based cohort. Uncertainty was assessed in sensitivity analyses.

Results: Synthetic mesh was less costly and more effective than biologic and no mesh to prevent PSH for all rectal cancer stages. At the willingness-to-pay threshold of £20,000/QALY, the incremental NMBs (95% CI) ranged between £3,412 (£3,384 to £3,439) (stage I) and £1,305 (£1,293 to £1,316) (stage IV) for synthetic versus no mesh, and £2,449 (£2,371 to £2,526) (stage I) and £1,784 (£1,753 to £1,815) (stage IV) for synthetic versus biologic mesh. Synthetic mesh was more cost-effective than no mesh unless the relative risk of PSH was ≥0.97 for stages I-III and ≥0.94 for stage IV.

Conclusions: Synthetic mesh was the most cost-effective strategy to prevent the formation of PSH in patients after end colostomy for any rectal cancer stage; however, conclusions are dependent on which subset of RCTs are considered to provide the most robust evidence.
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http://dx.doi.org/10.1111/codi.15848DOI Listing
July 2021

Use of prophylactic mesh during initial stoma creation to prevent parastomal herniation: a systematic review and meta-analysis of randomised controlled trials.

Colorectal Dis 2021 Jul 31. Epub 2021 Jul 31.

Royal Devon and Exeter Hospital, Royal Devon and Exeter NHS Foundation Trust, Exeter, UK.

Aim: Parastomal hernia (PSH) is a common complication following stoma creation. Previous reviews found mesh reinforcement during initial stoma creation beneficial in reducing PSH incidence. Since then, several multicentre randomised controlled trials (RCTs) produced widely ranging results rendering previous findings debatable. This current review assessed whether combining the latest larger multicentre RCTs would alter the previous findings.

Methods: The Cochrane Library, MEDLINE and Embase were searched from the respective dates of inception until 15 January 2021. RCTs were included if they compared mesh with no mesh during initial stoma creation in adult patients to prevent PSH. Included RCTs were summarised narratively and meta-analysed to estimate the relative risk (RR) of PSH incidence (primary analysis), peristomal complications and PSH repair (secondary analyses). Several subgroup analyses were performed, including mesh type (synthetic/biologic), surgical technique (open/laparoscopic) and mesh position (sublay/intraperitoneal).

Results: Thirteen RCTs were included in the primary meta-analysis (1070 patients); PSH incidence was reduced in patients with mesh compared with patients without mesh at maximal follow-up (RR = 0.54; 95% CI 0.39-0.77; I  = 67%; P < 0.01). The number of PSH repairs was fewer in patients who had mesh (RR = 0.63; 0.35-1.14; I  = 6%; P = 0.39), with no difference in peristomal complications (RR = 0.96; 0.55-1.70; I  = 0%; P = 0.71), comparing with no mesh. Subgroup analyses suggested that placing synthetic mesh using an open sublay technique might be more beneficial.

Conclusions: Prophylactic mesh reinforcement during initial stoma creation reduces PSH incidence and potentially its repair, without an increase in peristomal complications. However, substantial heterogeneity among included RCTs limits confidence in the results.
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http://dx.doi.org/10.1111/codi.15849DOI Listing
July 2021

Randomised controlled trial to establish the clinical and cost-effectiveness of expectant management versus preoperative imaging with magnetic resonance cholangiopancreatography in patients with symptomatic gallbladder disease undergoing laparoscopic cholecystectomy at low or moderate risk of common bile duct stones (The Sunflower Study): a study protocol.

BMJ Open 2021 06 29;11(6):e044281. Epub 2021 Jun 29.

Department of Hepatobiliary and Transplantation Surgery, Leeds Teaching Hospitals NHS Trust, Leeds, UK.

Introduction: Surgery to remove the gallbladder (laparoscopic cholecystectomy (LC)) is the standard treatment for symptomatic gallbladder disease. One potential complication of gallbladder disease is that gallstones can pass into the common bile duct (CBD) where they may remain dormant, pass spontaneously into the bowel or cause problems such as obstructive jaundice or pancreatitis. Patients requiring LC are assessed preoperatively for their risk of CBD stones using liver function tests and imaging. If the risk is high, guidelines recommend further investigation and treatment. Further investigation of patients at low or moderate risk of CBD stones is not standardised, and the practice of imaging the CBD using magnetic resonance cholangiopancreatography (MRCP) in these patients varies across the UK. The consequences of these decisions may lead to overtreatment or undertreatment of patients.

Methods And Analysis: We are conducting a UK multicentre, pragmatic, open, randomised controlled trial with internal pilot phase to compare the effectiveness and cost-effectiveness of preoperative imaging with MRCP versus expectant management (ie, no preoperative imaging) in adult patients with symptomatic gallbladder disease undergoing urgent or elective LC who are at low or moderate risk of CBD stones. We aim to recruit 13 680 patients over 48 months. The primary outcome is any hospital admission within 18 months of randomisation for a complication of gallstones. This includes complications of endoscopic retrograde cholangiopancreatography for the treatment of gallstones and complications of LC. This will be determined using routine data sources, for example, National Health Service Digital Hospital Episode Statistics for participants in England. Secondary outcomes include cost-effectiveness and patient-reported quality of life, with participants followed up for a median of 18 months.

Ethics And Dissemination: This study received approval from Yorkshire & The Humber - South Yorkshire Research Ethics Committee. Results will be submitted for publication in a peer-reviewed journal.

Trial Registration Number: ISRCTN10378861.
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http://dx.doi.org/10.1136/bmjopen-2020-044281DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8245448PMC
June 2021

Aspects and Challenges of Resource Use Measurement in Health Economics: Towards a Comprehensive Measurement Framework.

Pharmacoeconomics 2021 Sep 25;39(9):983-993. Epub 2021 Jun 25.

Department of Health Services Research, Care and Public Health Research Institute (CAPHRI), Faculty of Health Medicine and Life Sciences, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, Maastricht, The Netherlands.

Background: While the methods for conducting health economics research in general are improving, current guidelines provide limited guidance regarding resource use measurement (RUM). Consequently, a variety of methods exists, yet there is no overview of aspects to consider when deciding on the most appropriate RUM methodology. Therefore, this study aims to (1) identify and categorize existing knowledge regarding aspects of RUM, and (2) develop a framework that provides a comprehensive overview of methodological aspects regarding RUM.

Methods: Relevant articles were identified by enrolling a search string in six databases and handsearching the DIRUM database. Included articles were descriptively reviewed and served as input for a comprehensive framework. Health economics experts were involved during the process to establish the framework's face validity.

Results: Forty articles were included in the scoping review. The RUM framework consists of four methodological RUM domains: 'Whom to measure', addressing whom to ask and whom to measure; 'How to measure', addressing the different approaches of measurement; 'How often to measure', addressing recall period and measurement patterns; and 'Additional considerations', which covers additional aspects that are essential for further refining the methodologies for measurement. Evidence retrieved from the scoping review was categorized according to these domains.

Conclusion: This study clustered the aspects of RUM methodology in health economics into a comprehensive framework. The results may guide health economists in their decision making regarding the selection of appropriate RUM methods and developing instruments for RUM. Furthermore, policy makers may use these findings to review study results from an evidence-based perspective.
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http://dx.doi.org/10.1007/s40273-021-01048-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8352823PMC
September 2021
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