Assessment of Minimum Important Difference and Substantial Clinical Benefit with the Vascular Quality of Life Questionnaire-6 when Evaluating Revascularisation Procedures in Peripheral Arterial Disease.

OBJECTIVES: Patient reported outcomes are increasingly used to assess outcomes after peripheral arterial disease (PAD) interventions. VascuQoL-6 (VQ-6) is a PAD specific health-related quality of life (HRQoL) instrument for routine clinical practice and clinical research. This study assessed the minimum important difference for the VQ-6 and determined thresholds for the minimum important difference and substantial clinical benefit following PAD revascularisation. MATERIALS AND METHODS: This was a population-based observational cohort study. VQ-6 data from the Swedvasc Registry (January 2014 to September 2016) was analysed for revascularised PAD patients. The minimum important difference was determined using a combination of a distribution based and an anchor-based method, while receiver operating characteristic curve analysis (ROC) was used to determine optimal thresholds for a substantial clinical benefit following revascularisation. RESULTS: A total of 3194 revascularised PAD patients with complete VQ-6 baseline recordings (intermittent claudication (IC) n = 1622 and critical limb ischaemia (CLI) n = 1572) were studied, of which 2996 had complete VQ-6 recordings 30 days and 1092 a year after the vascular intervention. The minimum important difference 1 year after revascularisation for IC patients ranged from 1.7 to 2.2 scale steps, depending on the method of analysis. Among CLI patients, the minimum important difference after 1 year was 1.9 scale steps. ROC analyses demonstrated that the VQ-6 discriminative properties for a substantial clinical benefit was excellent for IC patients (area under curve (AUC) 0.87, sensitivity 0.81, specificity 0.76) and acceptable in CLI (AUC 0.736, sensitivity 0.63, specificity 0.72). An optimal VQ-6 threshold for a substantial clinical benefit was determined at 3.5 scale steps among IC patients and 4.5 in CLI patients. CONCLUSIONS: The suggested thresholds for minimum important difference and substantial clinical benefit could be used when evaluating VQ-6 outcomes following different interventions in PAD and in the design of clinical trials.

Patient characteristics and surgery-related factors associated with patient-reported recovery at 1 and 6 months after colorectal cancer surgery.

Predictors for postoperative recovery after colorectal cancer surgery are usually investigated in relation to length of stay (LoS), readmission, or 30-day morbidity. This study describes patient characteristics and surgery-related factors associated with patient-reported recovery 1 and 6 months after surgery. In total, 153 consecutively included patients who were recovering from colorectal cancer surgery reported their level of recovery using the Postoperative Recovery Profile. Multiple logistic regression analysis was used to calculate associations with recovery, defined as good or poor, divided into five recovery dimensions: physical symptoms, physical functions, psychological, social and activity. Better preoperative health predicted good recovery regarding three dimensions 1 month after surgery. Regarding all dimensions 1 month after surgery, poor recovery was predicted by a poor recovery on the day of discharge within corresponding dimensions. Higher age was associated with good recovery 6 months after surgery, while chemotherapy showed negative associations. Overall, a majority of factors had a negative impact on recovery, but without any obvious relation to one specific dimension or point in time. Those factors were: high Body Mass Index, comorbidity, abdominoperineal resection, loop ileostomy, colostomy and LoS. This study illustrates the complexity of postoperative recovery and a need for individualised follow-up strategies.