ABSTRACT
OBJECTIVE: Chronic limb threatening ischaemia (CLTI) is the most severe form of peripheral arterial disease. International guidelines recommend arterial revascularisation in patients with CLTI. However, these patients are often fragile elderly people with significant comorbidities, whose vascular anatomy is not always suitable for open or endovascular revascularisation. Recent studies have suggested acceptable outcomes of conservative treatment. A systematic review of the available literature was conducted to obtain best estimates of outcomes of conservative treatment in patients with CLTI. DATA SOURCES: MEDLINE, Embase, and Cochrane Central. REVIEW METHODS: A systematic review and meta-analysis was carried out following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. MEDLINE, Embase, and Cochrane Central were searched from inception until September 2019. All studies reporting on outcomes of conservative treatment for CLTI were considered. Study selection, data extraction, and risk of bias assessment were done by two investigators independently. Risk of bias was evaluated with a modified version of the Cochrane tool for observational studies. Outcomes of interest were all cause mortality, major amputation, and amputation free survival (AFS) after at least 12 months of follow up. A random effects model was used for meta-analyses. RESULTS: Twenty-seven publications were included, consisting of 12 observational studies and 15 placebo arms from randomised clinical trials, totalling 1 642 patients. Most studies included patients with non-reconstructable CLTI. Overall study quality was moderate. The pooled 12 month all cause mortality rate in 14 studies comprising 1 003 patients was 18% (95% confidence interval [CI] 13 - 25, I2 = 73%). The pooled major amputation rate from 14 studies comprising 755 patients was 27% (95% CI 20 - 36, I2 = 65%) after one year, and pooled AFS rate after 12 months in 11 studies with 970 patients was 60% (95% CI 52 - 67, I2 = 75%). CONCLUSION: Conservative treatment for patients with CLTI may be considered and does not always result in loss of limb or patient demise. The results of this review can be used to inform patients with CLTI about conservative treatment as part of a shared decision making process.
Subject(s)
Conservative Treatment , Extremities/blood supply , Ischemia/therapy , Peripheral Arterial Disease/therapy , Amputation, Surgical/statistics & numerical data , Chronic Disease , Humans , Ischemia/etiology , Ischemia/surgery , Mortality , Peripheral Arterial Disease/complications , Treatment OutcomeABSTRACT
OBJECTIVE: The 12-item "observing patient involvement" (OPTION(12))-instrument is commonly used to assess the extent to which healthcare providers involve patients in health-related decision-making. The five-item version (OPTION(5)) claims to be a more efficient measure. In this study we compared the Dutch versions of the OPTION-instruments in terms of inter-rater agreement and correlation in outpatient doctor-patient consultations in various settings, to learn if we can safely switch to the shorter OPTION(5)-instrument. METHODS: Two raters coded 60 audiotaped vascular surgery and oncology patient consultations using OPTION(12) and OPTION(5). Unweighted Cohen's kappa was used to compute inter-rater agreement on item-level. The association between the total scores of the two OPTION-instruments was investigated using Pearson's correlation coefficient (r) and a Bland & Altman plot. RESULTS: After fine-tuning the OPTION-manuals, inter-rater agreement for OPTION(12) and OPTION(5) was good to excellent (kappa range 0.69-0.85 and 0.63-0.72, respectively). Mean total scores were 23.7 (OPTION(12); SD=7.8) and 39.3 (OPTION(5); SD=12.7). Correlation between the total scores was high (r=0.71; p=0.01). OPTION(5) scored systematically higher with a wider range than OPTION(12). CONCLUSION: Both OPTION-instruments had a good inter-rater agreement and correlated well. OPTION(5) seems to differentiate better between various levels of patient involvement. PRACTICAL IMPLICATION: The OPTION(5)-instrument is recommended for clinical application.
