Dataset Information

Comparing the Clinical and Cost-Effectiveness of Abdominal-based Autogenous Tissue and Tissue-Expander Implant: A Feasibility Study.

ABSTRACT: Background: To determine the superiority of autologous abdominal tissue (AAT) or tissue-expander implant (TE/I) reconstruction, a robust comparative cohort study is required. This study sought to determine the feasibility of a future large pragmatic cohort study comparing clinical and cost-effectiveness of AAT and TE/I at 12 months postoperative.

Methods: Potential participants were screened during consultation with their surgeon. Three health-related quality-of-life scales, the Health Utility Index Mark 3, the 12-Item Short Form Health Survey, and the BREAST-Q were used preoperatively, 1, 6, and 12 months postoperatively. Direct medical costs and postoperative patient/caregiver productivity loss were collected using patient diaries. Feasibility was assessed through patient recruitment rates and compliance of patients and study staff to complete required study documentation.

Results: Sixty-three patients consented to participate, 44 completed baseline questionnaires; the feasibility objective of recruiting 80% of eligible patients was not met. A 90% completion rate for patient questionnaires was seen at 1-month follow-up and decreased up to 12 months. Quality-adjusted life years were calculated at 0.77 and 0.89 for the AAT and TE/I group, respectively. Case report form completion by study staff and patient diary completion was moderate and low, respectively. Collaborating with hospital case-costing specialists to identify direct medical costs was reliable and efficient.

Conclusions: A future large-scale study is feasible. However, due to a diminishing rate of questionnaire completion, almost twice as many patients need to be recruited than expected to have adequate power. Cost data collection from hospital sources was reliable. Case report forms need to be tailored more toward a busy hospital setting.

SUBMITTER: Thoma A

PROVIDER: S-EPMC7647508 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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Comparing the Clinical and Cost-Effectiveness of Abdominal-based Autogenous Tissue and Tissue-Expander Implant: A Feasibility Study.

Thoma Achilles A Avram Ronen R Dal Cin Arianna A Murphy Jessica J Duku Eric E Xie Feng F

Plastic and reconstructive surgery. Global open 20200411 10

<h4>Background</h4>To determine the superiority of autologous abdominal tissue (AAT) or tissue-expander implant (TE/I) reconstruction, a robust comparative cohort study is required. This study sought to determine the feasibility of a future large pragmatic cohort study comparing clinical and cost-effectiveness of AAT and TE/I at 12 months postoperative.<h4>Methods</h4>Potential participants were screened during consultation with their surgeon. Three health-related quality-of-life scales, the Hea ...[more]

PMID: 33173691

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Project description:BackgroundA third of deaths in the UK from ruptured abdominal aortic aneurysm (AAA) are in women. In men, national screening programmes reduce deaths from AAA and are cost-effective. The benefits, harms, and cost-effectiveness in offering a similar programme to women have not been formally assessed, and this was the aim of this study.MethodsWe developed a decision model to assess predefined outcomes of death caused by AAA, life years, quality-adjusted life years, costs, and the incremental cost-effectiveness ratio for a population of women invited to AAA screening versus a population who were not invited to screening. A discrete event simulation model was set up for AAA screening, surveillance, and intervention. Relevant women-specific parameters were obtained from sources including systematic literature reviews, national registry or administrative databases, major AAA surgery trials, and UK National Health Service reference costs.FindingsAAA screening for women, as currently offered to UK men (at age 65 years, with an AAA diagnosis at an aortic diameter of ≥3·0 cm, and elective repair considered at ≥5·5cm) gave, over 30 years, an estimated incremental cost-effectiveness ratio of £30 000 (95% CI 12 000-87 000) per quality-adjusted life year gained, with 3900 invitations to screening required to prevent one AAA-related death and an overdiagnosis rate of 33%. A modified option for women (screening at age 70 years, diagnosis at 2·5 cm and repair at 5·0 cm) was estimated to have an incremental cost-effectiveness ratio of £23 000 (9500-71 000) per quality-adjusted life year and 1800 invitations to screening required to prevent one AAA-death, but an overdiagnosis rate of 55%. There was considerable uncertainty in the cost-effectiveness ratio, largely driven by uncertainty about AAA prevalence, the distribution of aortic sizes for women at different ages, and the effect of screening on quality of life.InterpretationBy UK standards, an AAA screening programme for women, designed to be similar to that used to screen men, is unlikely to be cost-effective. Further research on the aortic diameter distribution in women and potential quality of life decrements associated with screening are needed to assess the full benefits and harms of modified options.FundingUK National Institute for Health Research Health Technology Assessment programme.

Project description:ObjectivesTo evaluate the cost effectiveness of soft tissue injury management by emergency nurse practitioners (ENPs) and extended scope physiotherapists (ESPs) compared with the routine care provided by doctors in an emergency department (ED).DesignRandomised, pragmatic trial of equivalence.SettingA single ED in England.Participants372 patients were randomised, 126 to the ESP group, 123 to the ENP group and 123 to the doctor group. Participants were adults (16 years and older) presenting to the ED with a peripheral soft tissue injury eligible for management by any of the three professional groups.InterventionsPatients were randomised to treatment by an ESP, ENP or routine care provided by doctors (of all grades).Main outcome measuresEconomic cost-minimisation evaluation from a funder perspective of the National Health Service, England incorporating analysis of the direct, indirect and tangible costs of care in primary and secondary settings.ResultsFrom a funder perspective in primary and secondary care, ESPs and ENPs are at best equivalent and could not cost less than routine care. Uncertainty in cost arises from ESPs and ENPs incurring greater indirect costs, such as those associated with follow-up appointments and subsequent primary care visits. Comparison from a funder perspective in secondary care, that is, considering those costs incurred in secondary care alone, demonstrates that ENPs are equivalent in cost to routine care, while ESPs are either equivalent or possibly cheaper than routine care.ConclusionsThese results question the notion that training the healthcare workforce to undertake extensions of their role is generally cost effective. While the randomised trial indicated that the three professional groups have equivalent clinical outcomes, this economic analysis suggests that substitution of routine care with a predominantly ESP or ENP workforce could prove more expensive. Further research is required to understand the underlying reasons for this. The trial has been registered with ISRCTN-ISRCTN 70891354.

Dataset Information

Comparing the Clinical and Cost-Effectiveness of Abdominal-based Autogenous Tissue and Tissue-Expander Implant: A Feasibility Study.

Publications

Comparing the Clinical and Cost-Effectiveness of Abdominal-based Autogenous Tissue and Tissue-Expander Implant: A Feasibility Study.

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