BEST-CLI: Analysis finds correlation between WIfI stage four CLTI and reports of poorer mental health

Jeffrey Siracuse

The BEST-CLI dataset has revealed a correlation between wounds, ischemia and foot infection (WIfI) stage and poorer quality of life due to mental, rather than physical, health for patients with chronic limb threatening ischemia (CLTI).

Analyzing complete WIfI data from a total of 1,568 enrollees, the prospective randomized BEST-CLI trial compared open and endovascular revascularization strategies for patients with CLTI due to infrainguinal peripheral arterial disease (PAD). The study assessed health-related quality of life (HRQoL), which was the prespecified secondary endpoint of the trial and was used at enrollment and designated follow-up points. This measurement included data from multiple surveys, including the Vascular Quality of Life questionnaire (VascuQoL); 12-item short-form survey (SF-12), including the utility index score (SF6D-R2), mental composite scale (MCS), and physical composite scale (PCS); and EQ-5D.

The results were recently published online in the Journal of Vascular Surgery (JVS).

Jeffrey Siracuse, MD, a professor of surgery and radiology at Boston University School of Medicine in Boston, and colleagues sought to establish a correlation between limb severity and health-related quality of life, including details specifically connected to the affected limb and post-intervention changes in preoperative HRQoL scores.

Distribution between WIfI stages was: 35.5% reporting stage four, 29.6% with stage three, 28.6% with stage two, and 6.3% with stage one. Analyzing these groups further, the authors found that patients presenting with WIfI stage four were more often men (74.9% vs 69.6%), current smokers (25.4% vs. 17.6%), had end-stage renal disease (13.3% vs 8.5%), diabetes (83.6% vs 60.2%), were not independently ambulatory (56.8% vs 38.5%), and had higher median morbidity scores (4 vs 3; p<0.05).

Examining the correlation between WIfI stage and the other assessment modes, the authors found stage four to be associated with worse/lower SF-12 mental component scale scores (estimate, -2.43; 95% confidence interval, -3.73 to -1.13; p<0.001) and SF6D-R2 scores (estimate, -0.02; 95% confidence interval, -0.03 to 0.001; p=0.04).

Siracuse et al stated that patients presenting with an advanced WIfI stage had lower HRQoL assessments related to their mental health, however, the remaining assessments (VascuQoL, SF-12 PCS, and EQ-5D) which focused mainly on physical health, did not show a correlation with advanced WIfI stage. The authors noted that WIfI stage four had VascuQoL scores that were comparable to groups one to three (-0.12; 95% CI, -0.25 to 0.02; p=0.09), though female sex, current smoking and preoperative opioid use were associated with a lower score. These factors were also associated with lower SF6D (-0.02; 95% CI, -0.03 to 0.001; p=0.04) and SF-12 MCS (-2.43; 95% CI, -3.73 to -1.13; p<0.001) and PCS (0.04; 95% CI, -0.89 to 0.97; p=0.93) scores. However they were not found to affect a lower EQ-5D score (-1.85; 95% CI, -4.22 to 0.52; p=0.13).

“The presence of concurrent mental stress is important in patients with CLTI and has most likely been undertreated,” Siracuse concluded. Analysis has been previously carried out on the relationship between mental health and CLTI—The Nottingham Health Profile’s study demonstrated a significant correlation between HRQoL in patients with PAD and difficulties in work, family life and hobbies.

The researchers pointed out that, unlike mental health assessments, the physical assessments did not correlate with advanced WIfI stage, however emphasized that this disparity may be due to scores being low across all stages. Siracuse continues: “The PCS is focused on physical aspects and the VascuQoL and EQ-5D have a high focus on physical health components. One possibility is that the physical impairment associated with all stages of CLTI is advanced, and thus, any differences between stages will be much less pronounced.”

Development of a “CLTI-specific” instrument to evaluate HRQoL is needed, Siracuse determined, noting their study had limitations, including the influence of the site of survey administration (clinic or preoperative area) on patient responses. Patients were also asked to complete the survey after they had been made aware of their limb threatening condition. Furthermore, the measurement instruments have not been individually validated for CLTI which required the use of multiple questionnaires.

Reflecting on the continued research required in this area, Siracuse observed: “An improved understanding of HRQoL considerations could better guide care for this complex and vulnerable patient population and enhance patient engagement for joint decision-making.”


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