Clinical outcomes and cost-effectiveness of three different compression systems in newly-diagnosed venous leg ulcers in the UK

Guest, Julian F.; Fuller, Graham W; Vowden, Peter

doi:10.12968/jowc.2017.26.5.244

Cited by 28 publications

(55 citation statements)

References 18 publications

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“…In clinical trials, subjective assessment may not be the most optimal method to determine wound healing status. Outside of clinical trials, in real‐world patient care settings, the treating clinician may not be a specialist in wound care, and there can be a lack of continuity of care due to patients being examined by different clinicians at different clinic visits . Furthermore, the paucity of data on how wounds were assessed in real‐world studies (Table ) further masks the degree of accuracy of outcome assessments outside a controlled environment.…”

Section: The Need For a Reliable Wound Assessmentmentioning

confidence: 99%

Defining complete wound closure: Closing the gap in clinical trials and practice

Gould

2019

Wound Repair Regeneration

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We investigate how wound closure is determined in recent randomized controlled wound trials and real-world studies, identify solutions to the current limitations of wound assessment, and propose a standard methodology to define and assess wound healing in research. We searched PubMed for randomized clinical trials using the terms "complete wound closure" and "wound healing rate" and for real-world studies using the terms "real-world wound healing," "real-world wound data," and "wound registries" dating from March 2010 through March 2018. We selected studies that had "complete wound closure" or "healed wound" as an endpoint. Sixty-five trial articles and 10 real-world articles met our criteria, from which we extracted the wound type studied, definition of healed wound used, wound assessment method, the number of weeks assessed, the number of wounds, and the percent of healed wounds in the study group(s) and control group. There were 7,194 trial wounds included. The most common definition of healing used by 26 studies (40.6%) was complete/full/100% (re)epithelialization or closure without discharge, drainage/scab, and/or dressing. Fiftytwo studies (81.2%) used blinded wound assessment, and at least 10 studies (15.6%) used blinded adjudication. The real-world studies analyzed more than 901,396 wounds. Only three studies (33.3%) defined a healed/closed wound, two of which used "complete epithelialization." Eight studies (88.9%) did not define the wound assessment method; none indicated a blinded assessment. We support the Food and Drug Administration definition: 100% reepithelialization of the wound surface with no discernable exudate and without drainage or dressing, confirmed at two visits 2 weeks apart, and we recommend blinded adjudication for wound assessment. The widespread adoption of a standard wound healing definition and assessment method in wound care research would allow for stronger comparisons of treatment effects across studies to improve the evidence base and strengthen the treatment decisionmaking process in clinical practice.

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Section: The Need For a Reliable Wound Assessmentmentioning

confidence: 99%

Defining complete wound closure: Closing the gap in clinical trials and practice

Gould

2019

Wound Repair Regeneration

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“…The most common intervention type across the studies was dressings for VLUs, the subject of 11 studies (48%) [24][25][26][27][28][29][30][31][32][33][34]. There were also four studies each focusing on compression bandaging [35][36][37][38] and extracellular matrices [39][40][41][42]. The other interventions included in papers in the review were electric stimulation therapies [43,44], barrier creams [45] and pentoxifylline oral medication [46].…”

Section: Study Characteristicsmentioning

confidence: 99%

“…There were 11 cost effectiveness analyses (CEAs) [26, 28-33, 35, 40-42] and three cost utility analyses (CUAs) [25,36,38], with the remaining nine studies a combination of both CEA and CUA [24,27,34,37,39,[43][44][45][46]. For the CEAs, the most common clinical outcome related to percentage of patients healed (12 outcomes) [26,27,30,32,33,37,39,[41][42][43][44][45], with time taken for the ulcer to heal used as an outcome in ten studies [24, 25, 29, 31, 34-36, 41, 42, 46], and reduction in wound area size used twice [28,29]. It should be noted that whilst these outcome measures may be clinically meaningful within VLUs, they do not have a willingness-to-pay threshold attached to them [such as with the quality-adjusted life-year (QALY)], and they do not facilitate comparison with other economic evaluations conducted within other disease areas.…”

Section: Study Characteristicsmentioning

confidence: 99%

“…For the CUAs, QALYs were the only measurement of utility used. Nine decision-analytic models sourced utilities for their QALY measurements from the 2007 study by Clegg and Guest [25,27,34,36,37,39,[43][44][45]. This paper used standard gamble methodology on a sample of 200 participants, including both the general population and VLU patients, to allow for utilities to be assigned to different VLU states [44].…”

Section: Study Characteristicsmentioning

confidence: 99%

“…Other time horizons varied greatly, from 14 days [28] to 12 years [38]. Decision-tree models were used in five studies [27,30,31,36,45], and the remaining six studies did not explicitly state their model type [25,26,32,33,37,40]. For these six studies, no figure was included to describe the model structure, making it difficult to appreciate the type of model used.…”

Section: Study Characteristicsmentioning

confidence: 99%

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A Systematic Review of Model-Based Economic Evaluations of Treatments for Venous Leg Ulcers

Layer

McManus

Levell

2019

PharmacoEconomics Open

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Objective The aim of this review was to identify, and assess the quality of, published model-based economic evaluations relating to treatments for patients with venous leg ulcers to help inform future decision-analytic models in this clinical area. Methods A systematic literature search was performed on six electronic databases, from database inception until 21 May 2018. Search results were screened against predefined criteria by two independent reviewers. Data was then extracted from the included studies using a standardised form, whilst the decision-analytic model-specific Philips Checklist was used to assess quality and to inform model critique. Results A total of 23 models were identified, 12 studies used a Markov modelling approach, five used decision trees and six studies did not detail the model type. Studies were predominantly from the National Health Service (NHS)/payer perspective, with only two taking a societal perspective. Interventions were wide ranging, but dressing technologies (11/23) were most common. The intervention studied was found to be dominant in 22/23 studies. The reporting quality of papers was mostly low, with evidence behind model structures, time horizons and data selection consistently underreported across the included papers. Conclusions This review has identified a sizeable literature of model-based economic evaluations, evaluating treatments for venous leg ulcers. However, the methods used to conduct such studies were generally poorly reported. In particular, the reporting of evidence surrounding the model structure, justification of the time horizon used and the rationale for selecting data inputs should be focused on in any future models developed.

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Electronic Health Record Databases

Horton

Bhullar

Carty

et al. 2019

Pharmacoepidemiology

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Clinical outcomes and cost-effectiveness of three different compression systems in newly-diagnosed venous leg ulcers in the UK

Cited by 28 publications

References 18 publications

Defining complete wound closure: Closing the gap in clinical trials and practice

Defining complete wound closure: Closing the gap in clinical trials and practice

A Systematic Review of Model-Based Economic Evaluations of Treatments for Venous Leg Ulcers

Electronic Health Record Databases

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