A Scoping Review of Decision Support Tools for Patients with Lower Extremity Arterial Disease: Toward Shared Decision-Making.

BACKGROUND: In recent years, decision support tools (DSTs) in various fields of medicine have emerged to aid clinicians and patients in the process of shared decision-making (SDM). This scoping review aims to identify the existing DSTs for selecting treatments in lower extremity arterial disease and to evaluate their effectiveness in facilitating SDM. METHODS: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines for scoping reviews were followed. A literature search was conducted across MEDLINE, EMBASE, and Cochrane databases, along with the Decision Aid Library Inventory, for studies published between January 2000 and June 2023. Articles reporting the development and/or clinical application of a DST specific to lower extremity arterial disease were included. A narrative synthesis of the results was performed and findings were presented in tabular formats. RESULTS: Five studies and 5 unique DSTs were included. Presenting formats included websites, booklets, brochures, and pocket cards. Overall, a high degree of heterogeneity was observed across all DSTs in their format, content, and delivery. A widespread acceptability and satisfaction were reported among patients and clinicians. However, their effect at improving SDM remains uncertain due to the lack of standardized outcome metrics. CONCLUSIONS: The development and implementation of DSTs for lower limb arterial disease treatment discussion remain in the early stages. This review lays the foundation for future studies to continue exploring optimal strategies for DST development and their role in supporting SDM.

A Systematic Review of the Quality of Clinical Practice Guidelines for Chronic Limb-Threatening Ischemia.

BACKGROUND: To assess the quality of clinical practice guidelines (CPGs) for chronic limb-threatening ischemia (CLTI) using the Appraisal of Guidelines for Research and Evaluation II instrument. METHODS: A systematic review of Medline, Embase, and online CPG databases was carried out. Four CPGs on CLTI were identified: Global Vascular Guidelines (GVG), European Society of Cardiology (ESC), American College of Cardiology, and National Institute for Health and Care Excellence guidelines on lower limb peripheral arterial disease. Two independent appraisers analyzed the 4 CPGs using the Appraisal of Guidelines for Research and Evaluation II instrument. CPGs were ranked across 6 domains with 23 items that ranged from 1 (strongly disagree) to 7 (strongly agree). A scaled domain score was calculated as a percentage of the maximum possible score achievable. A domain score of ≥50% and an overall average domain score of ≥80% reflected a CPG of adequate quality recommended for use. RESULTS: GVG had the highest overall score (82.9%), as an average of all domains, and ESC had the lowest score (50.2%). GVG and National Institute for Health and Care Excellence guidelines had all domains scoring >50%, while American College of Cardiology had 5 and ESC had 3. Two domains, rigor of development and applicability, scored the lowest among the CPGs. There was a lack of detail in describing systematic methods used in the literature review, how guidelines were formulated with minimal bias, and the planned procedure for updating the guidelines. Implications of guideline application and monitoring of outcomes after implementations were not explicitly discussed. CONCLUSIONS: The GVG guideline published in 2019 discussing CLTI is assessed to be of high quality and recommended for use. This review helps to improve clinical decision-making and quality of future CPGs for CLTI.

Measuring Quality of Life in Chronic Limb-threatening Ischemia Patients and Informal Carers: A Scoping Review.

OBJECTIVE: To review quality of life (QOL) instruments for chronic limb-threatening ischemia (CLTI) patients and informal carers, and their use in QOL and cost-utility analysis (CUA) studies. BACKGROUND: CLTI is a global health problem with significant morbidity affecting patients and informal carers. QOL is increasingly measured for holistic outcomes assessment and CUA. However, measurement instruments in CLTI are poorly understood. METHODS: MEDLINE, EMBASE, PsycINFO, CINAHL, COSMIN, PROQOLID, CEA registry, and NHS EED databases were searched for all English language studies up to May 2021. Features of instruments, evidence of measurement property appraisal, and trends in use were assessed. Prospective protocol registration (Open Science Framework: https://doi.org/10.17605/OSF.IO/KNG9U ). RESULTS: A total of 146 studies on QOL instruments (n=43), QOL outcomes (n=97), and CUA (n=9) were included. Four disease-specific QOL instruments are available for lower extremity arterial disease (intermittent claudication or CLTI). VascuQoL-25 and VascuQoL-6 have been used in CLTI. There is no CLTI-specific instrument. Of 14 generic instruments, SF-36, EQ-5D-3L, NHP, and WHOQOL-BREF were most common. Studies reporting partial measurement property appraisal favored VascuQoL-25, VascuQoL-6, and SF-36. Feasibility considerations include mode of administration and responder burden. None of 4 available carer-specific instruments have been used in CLTI. Since 1992, the number of QOL studies has increased considerably, but CUA studies are scarce. Informal carers have not been assessed. CONCLUSIONS: This review provides a comprehensive reference for QOL measurement in CLTI that helps end-users with instrument selection, use, and interpretation. However, a CLTI-specific instrument is needed. There is an opportunity to benefit society through future CUA studies and evaluation of QOL in informal carers.

Quality of Life in Chronic Limb Threatening Ischaemia: Systematic Review and Meta-Analysis.

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.

A Systematic Review of Cost-Utility Analyses in Chronic Limb-Threatening Ischemia.

BACKGROUND: To review and describe the available literature on cost-utility analysis of revascularization and non-revascularization treatment approaches in chronic limb-threatening ischemia. METHODS: A systematic review was performed on cost-utility analysis studies evaluating revascularization (open surgery or endovascular), major lower extremity amputation, or conservative management in adult chronic limb-threatening ischemia patients. Six bibliographic databases and online registries were searched for English language articles up to August 2021. The outcome for cost-utility analysis was quality-adjusted in life years. Procedures were compared using incremental cost-effectiveness ratios which were converted to 2021 United States dollars. Study reporting quality was assessed using the 2022 Consolidated Health Economic Evaluation Reporting Standards statement. The study was registered in International Prospective Register of Systematic Reviews (CRD42021273602). RESULTS: Three trial-based and five model-based studies were included for review. Studies met between 14/28 and 20/28 criteria of the Consolidated Health Economic Evaluation Reporting Standards CHEERS statement. Only one study was written according to standardized reporting guidelines. Most studies evaluated infrainguinal disease, and adopted a health care provider perspective. There was a large variation in the incremental cost-effectiveness ratios presented across studies. Open surgical revascularization (incremental cost-effectiveness ratios: $3,678, $58,828, and $72,937), endovascular revascularization (incremental cost-effectiveness ratios: $52,036, $125,329, and $149,123), and mixed open or endovascular revascularization (incremental cost-effectiveness ratio: $8,094) maybe more cost-effective than conservative management. CONCLUSIONS: The application of cost-utility analyses in chronic limb-threatening ischemia is in its infancy. Revascularization in infrainguinal disease may be favored over major lower extremity amputation or conservative management. However, data is inadequate to support recommendations for a specific treatment. This review identifies short and long-term considerations to address the current state of evidence. Cost-utility analysis is an important tool in healthcare policy and should be encouraged amongst the vascular surgical community.

A Review of Illness Perceptions in Chronic Limb-Threatening Ischemia: Current Knowledge Gaps and a Framework for Future Studies.

BACKGROUND: The aim of this study is to review illness perceptions (IPs) in chronic limb-threatening ischemia (CLTI) patients undergoing revascularization (open surgical or endovascular), major lower extremity amputation, or conservative management. METHODS: MEDLINE, EMBASE, PsycINFO, CINAHL, WOS, and Scopus databases were searched from inception to August 20, 2021 for studies evaluating IP in CLTI according to Leventhal's common sense model (CSM). Since only 1 study was identified, a post hoc secondary literature search of MEDLINE was performed for reviews of IP in cardiovascular disease and diabetes to identify potential learning points for future research. All studies underwent narrative synthesis guided by tabulated data. RESULTS: One study and 7 reviews were included from the primary and secondary literature searches, respectively. Timeline and controllability were the main aspects of IP that predict prosthetic use in CLTI patients, more so at 6 months than 1 month. Other reviews in cardiovascular disease and diabetes identified important targets for future research: (1) factors that affect IP and whether IP can be used as an outcome measure, (2) relationship between IP and clinician-reported and patient-reported outcomes, and (3) methods to educate and change maladaptive IP. The importance of using valid and reliable measures of IP that encompass all components of Leventhal's' CSM was stressed. CONCLUSIONS: Knowledge of IP in CLTI patients is severely limited in contrast to other fields in cardiovascular disease and diabetes. This review helps to close this gap by raising awareness of IP and its importance within the vascular surgical community, and by providing a framework for future studies.

Liver transplantation: a systematic review of long-term quality of life.

BACKGROUND & AIMS: Liver transplantation is the only curative intervention for terminal liver disease. Accurate long-term quality of life (QOL) data are required in the context of improved surgical outcomes and increasing post-transplant survival. This study reviews the long-term QOL after primary liver transplantation in adult patients surviving 5 or more years after surgery. METHODS: A literature search was conducted on PubMed for all studies matching the eligibility criteria between January 2000 and October 2013. Bibliographies of included studies were also reviewed. Two authors independently performed screening of titles and abstracts. Consensus for studies included for review was achieved by discussion between authors based on predetermined eligibility criteria. Quality appraisal and data tabulation were performed using predetermined forms. Results were synthesized by narrative review. RESULTS: Twenty-three studies (5402 patients) were included. QOL following liver transplantation remains superior to preoperative status up to 20 years post-operatively. More post-operative complications predicted worse QOL scores especially in physical domains. Benefits in functional domains persist long-term with independence in self-care and mobility. Employment rates recover in the short-term but decline after 5 years, and differ significantly between various aetiologies of liver disease. Overall QOL improves to a similar level as the general population, but physical function remains worse. Participation in post-operative physical activity is associated with superior QOL outcomes in liver transplant recipients compared to the general population. QOL improvements are similar compared to lung, kidney and heart transplantation. Heterogeneity between studies precluded quantitative analysis. CONCLUSIONS: Liver transplantation confers specific long-term QOL and functional benefits when compared to preoperative status. This information can assist in providing a more complete estimate of the overall health of liver transplant recipients and the effectiveness of surgery. Guidelines for future studies are provided.

Patient perspectives of quality of life in chronic limb-threatening ischemia: a qualitative study.

BACKGROUND: Quality of life (QOL) is an outcome that matters to patients with chronic limb-threatening ischemia (CLTI). However, we identified the lack of and need for a CLTI-specific QOL instrument. Our group is developing this instrument which requires a deep understanding of patient perspectives of QOL in CLTI. METHODS: Qualitative inquiry with patient and public involvement was performed in accordance with the Standards for Reporting Qualitative Research. Reflexive thematic analysis of semi-structured interviews was conducted within a constructivist-interpretivist research paradigm. Data were organized and managed in NVivo. Techniques to enhance trustworthiness included maintaining an audit trail, member checking, mentoring, and peer-debriefing. Patient and the public were consulted for feedback on codes, themes, and thematic maps. RESULTS: Thirteen participants (median age: 74 years, range: 43-90 years) with a variety of patient demographics were interviewed. Four themes were developed on QOL in CLTI: (i) 'independence as key to life satisfaction', (ii) 'change in identity when continuity is needed', (iii) 'coping with intractable disease', and (iv) 'not wanting to be alone'. Member checking with patient and public involvement confirmed the relevance and centrality of these themes to the lived experiences of patients with CLTI. CONCLUSIONS: The thematic outputs contribute important insights into what QOL truly means to patients with CLTI and what matters for their QOL. The content validity of the new CLTI-specific QOL instrument is improved by giving patients voice. This study highlights the value of qualitative inquiry and patient and public involvement in vascular surgical research.

A systematic review and meta-analysis of quality of life outcomes after radical cystectomy for bladder cancer.

BACKGROUND: Radical cystectomy and urinary diversion is the treatment of choice for invasive bladder cancer. Quality of life (QOL) is an important outcome of surgery. This review compares the QOL after continent and incontinent urinary diversion in radical cystectomy for patients with primary invasive bladder cancer. METHODS: A systematic review and meta-analysis of clinical studies published after January 2000 was performed according to the PRISMA guidelines. Quality appraisal and data tabulation were performed using pre-determined forms. Data were synthesised by narrative review and random-effects meta-analysis using standardized response means. Heterogeneity and bias was assessed by Tau(2) and I(2) values and Funnel plots. RESULTS: Twenty-nine studies (3754 patients) were included for review. Pooled post-operative FACT and SF-36 scores showed no difference in overall QOL between continent and incontinent diversion (p = 0.31). Subgroup analysis demonstrated greater improvement in physical health for incontinent (p = 0.002) compared to continent diversions, but no differences in mental health (p = 0.35) and social health (p = 0.81). Qualitative analysis showed patients with neobladder had superior emotional function and body image compared to cutaneous diversion. QOL may improve to similar or better levels compared to baseline after 1 year, but data remains scarce. Patients report poor urinary and sexual function after surgery compared the general population. Long-term QOL is unclear. Levels of heterogeneity and bias were low. CONCLUSIONS: QOL after radical cystectomy is comparable after either continent or incontinent urinary diversion. Post-operative QOL may improve, but urinary and sexual dysfunction remains inferior to the general population. Patient choice is key to selection of reconstruction method.

Quality of life after cytoreductive surgery and hyperthermic intra-peritoneal chemotherapy for peritoneal carcinomatosis: A systematic review and meta-analysis.

OBJECTIVE: To review the effect of cytoreductive surgery (CRS) and hyperthermic intra-peritoneal chemotherapy (HIPEC) on health-related quality of life (HRQOL) in patients with peritoneal carcinomatosis. BACKGROUND: CRS and HIPEC is increasingly performed with curative intent for peritoneal carcinomatosis. Significant morbidity rates are reported in the context of limited life-expectancy, necessitating accurate post-operative HRQOL outcome data. METHODS: A systematic review of clinical studies published after January 2000 was performed using strict eligibility criteria. Key outcomes measures were post-operative HRQOL compared to pre-operative levels and reference populations. Quality appraisal and data tabulation were performed using pre-determined forms. Data were synthesised by narrative review and random-effects meta-analysis. Tau2 and I2 values and Funnel plots were analysed for consistency and bias. RESULTS: 15 studies (1583 patients) were included. HRQOL declines at the 3-4 month time-point before becoming similar or better compared to pre-operative levels at 1 year. The pooled-effects of combined post-operative functional assessment of cancer therapy and European organisation for research and treatment quality of life questionnaire scores were significantly improved from baseline on overall health status (p=0.001) and emotional health (p=0.001). Physical health (p=0.83), social health (p=0.48) and functional health (p=0.24) remain similar. HRQOL after 1 year is less clear, but benefits may persist up to 5 years especially on overall and physical health domains. Evidence is conflicted and inconclusive on HRQOL compared to reference populations. Levels of consistency and bias were acceptable. CONCLUSIONS: CRS and HIPEC for peritoneal carcinomatosis can confer small to medium benefits for HRQOL. These results should be interpreted with in caution due to the small studies and absence of more randomised controlled trials.