Objective: To assess the comparative effectiveness and temporal changes in quality of life (QoL) outcomes after revascularisation, major lower extremity amputation (MLEA), and conservative management (CM) in chronic limb threatening ischaemia (CLTI).
Data Sources: MEDLINE, Embase, PsycINFO, CINAHL, and Web of Science.
Review Methods: A systematic review and meta-analysis were performed on QoL measured by any QoL instrument in adult patients with CLTI after open surgery (OS), endovascular intervention (EVI), MLEA, or CM. Randomised controlled trials and prospective observational studies published in any language between 1 January 1990 and 21 May 2021 were included. There was a pre-specified measurement time point of six months. Random effects meta-analysis was conducted on total scores for each QoL instrument. Certainty of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluations approach (PROSPERO registration: CRD42021253953).
Results: Fifty-five studies with 8 909 patients were included. There was significant heterogeneity in the methods used to measure QoL, and the study characteristics. In particular, 14 different QoL instruments were used with various combinations of disease specific and generic instruments within each study. A narrative summary is therefore presented. Comparative effectiveness data showed there was reasonable certainty that QoL was similar between OS and EVI at six months. Temporal outcomes suggested small to moderate improvements in QOL six months after OS and EVI compared with baseline. Limited data indicated that QoL can be maintained or slightly improved after MLEA or CM. Treatment effects were overestimated owing to small study effects, selective non-reporting, attrition, and survivorship bias. Conclusion: QoL after OS and EVI appears to be similar. Revascularisation may provide modest QoL benefits, while MLEA or CM can maintain QoL. However, certainty of evidence is generally low or very low, and interpretation is hampered by significant heterogeneity. There is a need for a CLTI specific QoL instrument
and methodological standardisation in QoL studies
The primary aim was to assess the comparative effectiveness of revascularisation (by open surgery [OS] or endovascular intervention [EVI]), major lower extremity amputation (MLEA), and conservative management (CM) on QoL outcomes in patients with CLTI. The secondary aim was to evaluate temporal changes in QoL and their association with ClinROs.
ContributorsLeonard L. Shan, Linda S. Yang, Michelle Tew, Mark J. Westcott, Tim D. Spelman, Peter F. Choong, Alun H. Davies
Disease Category: Heart & circulation
Disease Name: Chronic limb threatening ischaemia
Age Range: Unknown
Sex: Either
Nature of Intervention: Other, Surgery
- Systematic review of outcome measures/measurement instruments
- Systematic review
On 21 May 2021, MEDLINE (Ovid), Embase (Ovid), PsycINFO (Ovid), CINAHL (EBSCOhost), and Web of Science were searched for studies published in any language from 1 January 1990 onwards