Meta AnalysisID 4013
基于伤口蛋白酶活性升高的'检测与治疗'策略促进下肢静脉溃疡愈合：Cochrane方案
CRD42015027121
To determine the effects on wound healing of a 'test and treat' strategy for diagnosing and treating high levels of wound protease activity in people with venous leg ulcers.
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Record Fields
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- Meta Analysis Id
- 4013
- Evidence Id
- 12571
- Core Evidence Id
- 12571
- Source Meta Analysis Id
- 3972
- Herb2 Meta Analysis Id
- HBMA003972
- Crd Id
- CRD42015027121
- Title
- A 'test and treat' strategy for elevated wound protease activity for healing in venous leg ulcers [Cochrane Protocol]
- Review Question
- To determine the effects on wound healing of a 'test and treat' strategy for diagnosing and treating high levels of wound protease activity in people with venous leg ulcers.
- Study Type Included
- We will include published and unpublished randomised controlled trials (RCTs), including cluster RCTs, irrespective of the language of report. We will exclude quasi-randomised studies. We will only include RCTs reported only as abstracts when available data (either from the abstract itself or from the study authors) are sufficient for reasonable data extraction.
- Condition Being Studied
- The Cochrane Wounds Group
- Participant
- We will include trials recruiting adults described as having venous leg ulcers, managed in any setting. We will accept study authors' definitions of venous leg ulcers and will note the diagnostic methods and criteria used. We will include trials which recruited people with venous leg ulcers and those with other types of complex wounds if the results for people with venous leg ulcers are presented separately or are available from the authors. We will include participants at any stage in their treatment pathway, e.g. participants with or without hard to heal ulcers and with or without clinical infection of ulcers.
- Animal
- Human Disease Modelled
- Intervention
- We will include any RCT which evaluates a test and treat strategy for elevated protease activity in venous leg ulcers. In these studies the use of a specific test and treat strategy will be the only systematic difference between treatment groups. This will include trials in which all participants in the comparison arm received the same protease-modulating treatment but where a test and treat strategy was applied in the intervention arm as well as trials comparing test and treatment combinations versus each other, versus other interventions, or versus standard care. This may include comparisons of different test thresholds for the same test. We will include RCTs whether or not compression therapy is reported as a concurrent treatment as long as the study groups received the same compression protocols. Where possible we will assess the impact of concurrent compression therapy on the treatment effect (see Subgroup analysis and investigation of heterogeneity). We will exclude studies in which the test result is part of the inclusion criteria, i.e. participants with a positive test result were randomised to different protease-modulating treatments or to protease-modulating versus alternative treatments, as these will be included in a concurrent review evaluating protease-modulating matrix treatments for venous leg ulcers (Westby 2014).
- Comparator Control
- We will include any RCT which evaluates a test and treat strategy for elevated protease activity in venous leg ulcers. In these studies the use of a specific test and treat strategy will be the only systematic difference between treatment groups. This will include trials in which all participants in the comparison arm received the same protease-modulating treatment but where a test and treat strategy was applied in the intervention arm as well as trials comparing test and treatment combinations versus each other, versus other interventions, or versus standard care. This may include comparisons of different test thresholds for the same test.
- Main Outcome
- The primary effectiveness outcome for this review is wound healing. Trialists use a range of different methods of measuring and reporting this outcome. We will regard the following as the most relevant and rigorous measures of wound healing: Time to complete wound healing (correctly analysed using survival, time-to-event approaches). Ideally the outcome will be adjusted for appropriate covariates, e.g. baseline ulcer area/duration. Proportion of wounds completely healed during follow-up (frequency of complete healing).</ul> We will use authors’ definitions of complete wound healing; these will be reported. Where both of the outcomes above are reported, we will present all data in a summary outcome table for reference but will focus on reporting time to healing. When time is analysed as a continuous measure, but it is not clear whether all wounds healed, we will document the use of the outcome in the study, but we will not extract, summarise or use the data in any meta-analysis. The primary safety outcome is all reported adverse events. Where reported, we will extract data on all serious adverse events and all non-serious adverse events where a clear methodology for the collection of adverse event data was provided. This methodology should make it clear whether events were reported at the participant level or, where multiple events/person were reported, that an appropriate adjustment has been made for data clustering. We will not extract individual types of adverse events other than pain or infection (see Secondary outcomes). We will note where events are reported as being treatment-related.
- Outcome Measure
- Additional Outcome
- We will include the following secondary outcomes: Health-related quality of life: we will include quality of life where it is reported using a validated scale such as the SF-36 or EQ-5D or a validated disease-specific questionnaire such as the Cardiff Wound Impact Schedule. Ideally reported data will be adjusted for the baseline score. We will not include ad hoc measures of quality of life that are unlikely to be validated and would not be common to multiple trials. Pain scores: we will include pain (including pain at dressing change) only where mean scores with a standard deviation are reported using a scale validated for the assessment of pain levels, such as a visual analogue scale (VAS). Change (and rate of change) in wound size, with adjustment for baseline size (we will contact study authors to request adjusted means when not presented). When change or rate of change in wound size is reported without adjustment for baseline size, use of the outcome in the study will be documented, but data will not be extracted, summarised or used in any meta-analysis. Change in wound infection status (as defined by the study authors): we will include measures of incident cases of infection and cases of existing infections being resolved. We will not extract data on microbiological assays not clearly linked to a diagnosis of infection. We will use authors' definitions of infection. Resource use (when presented as a mean with standard deviation) including measures of resource use such as appointments for undergoing tests and receiving test results, number of dressing changes, number of nurse visits, length of hospital stay, need for other interventions. Costs associated with resource use (including estimates of cost-effectiveness).</ul>
- Study Method
- Keyword
- Humans; Peptide Hydrolases; Treatment Effectiveness; Varicose Ulcer; Wound Healing
- Contact
- Gill Norman [email protected]
- Organisational Affiliation
- The Cochrane Collaboration http://www.cochrane.org/
- Funding Source
- School of Nursing, Midwifery and Social Work, University of Manchester, Department of Health Sciences, University of York, National Institute for Health Research, School of Nursing, Midwifery and Social Work, University of Manchester, Department of Health Sciences, University of York, National Institute for Health Research
- Other Selection Criteria
- Final Publication
- Same Topic Review
- Published Protocol
- Review Type
- Language
- English
- Country
- England
- Review Stage
- Review Ongoing
- First Submission Date
- Registration Date
- 2015-10-14
- Anticipated Start Date
- 2015-06-15
- Anticipated Completion Date
- 2017-06-15
- Title Cn
- 基于伤口蛋白酶活性升高的'检测与治疗'策略促进下肢静脉溃疡愈合：Cochrane方案
- Title En
- A 'test and treat' strategy for elevated wound protease activity for healing in venous leg ulcers [Cochrane Protocol]
- Bilingual Status
- complete