Construct validation and comparison of a novel postoperative quality-of-life metric and the Short Form-36 in colorectal surgery patients.

PURPOSE: Several methods have been used to measure quality of life (QOL) in colorectal patients, but existing QOL assessment tools are often complex, require complicated analysis, lack specificity for colorectal surgery, and are not focused on assessment of perioperative care. The postoperative QOL (PQL) assessment is designed to capture subtle yet important QOL factors in an easy tool validated for the postoperative period. Although internally validated, PQL lacks external validation with a universally accepted QOL metric, such as the Rand Short Form-36 (SF-36). The purpose of this study was to externally validate the PQL metric to the SF-36 for colorectal surgery. METHODS: The PQL was designed using 14 questions ranked on a Likert scale (1-10) with surgeon and patient input. After obtaining institutional review board approval, 100 consecutive colorectal surgery patients at University Hospitals, Case Medical Center were administered baseline and postoperative (2, 4, 8, 12, 30, 60, and 90 days) PQL and SF-36 questionnaires prospectively. Patients undergoing colorectal surgery via an abdominal approach (laparoscopic or open) for benign or malignant disease were included. Factor analysis and Spearman's rank test were performed between each of the 8 SF-36 scales and the 14 PQL questions and summary score. Convergent validity was demonstrated using Spearman's correlation coefficient at the domain and scale levels. The degree of agreement between PQL and SF-36 was assessed through Bland-Altman plots. Pairwise comparisons were made to determine any significant differences between the 2 scales. RESULTS: Eighty-eight patients met all inclusion criteria and had a complete dataset, and were included in the analysis. SF-36 factor analysis confirmed comparability between the study group and the general population. All PQL items correlated with all 8 mental and physical health domains in the SF-36 (P < .0001). Bland-Altman plots demonstrated consistently similar measure for level of agreement between PQL and SF-36 as indicated by the 95% limits of agreement. CONCLUSION: The PQL and SF-36 demonstrated a strong and consistent level of agreement across all 8 domains for pre- and postoperative scores in colorectal surgery patients. PQL is constructually valid in the perioperative period. Based on our analysis, the novel PQL metric represents a simple, point-of-care alternative to SF-36 for rapid QOL assessment, and validates use of the PQL metric in abdominal surgery.

Validation of a novel postoperative quality-of-life scoring system.

BACKGROUND: No specific scoring system exists for the assessment of postoperative quality of life (QOL) after major abdominal surgery. This study prospectively validates PQL, a novel prospective scoring system in patients having laparoscopic or open major abdominal colorectal surgery. METHODS: Six experienced surgeons developed the questionnaire. Twenty patients reviewed and selected the most relevant questions, yielding 14 questions. One hundred patients undergoing a variety of colorectal procedures completed the questionnaire preoperatively, and on postoperative days (POD) 1, 2, 4, 8, 12, 30, and 60. Internal validation was assessed by Cronbach's alpha and factor analysis. RESULTS: Cronbach's alpha revealed excellent internal consistency, ranging from .84 to .94 at all time points, even at POD 1 when Cronbach's alpha was .79, demonstrating that the items in the questionnaire measured the same underlying construct. Factor analysis consistently loaded at each follow-up time on the same 2 factors. CONCLUSIONS: Factor analysis consistently loaded at each follow-up time on the same 2 factors, designated the PQL Symptom Score and the PQL Recover Score.

Prospective assessment of Cleveland Global Quality of Life (CGQL) as a novel marker of quality of life and disease activity in Crohn's disease.

OBJECTIVES: The Short Form 36 (SF-36) questionnaire is the most widely accepted measure of quality of life (QOL); however, it is cumbersome to use and requires complicated analysis. The Cleveland Global Quality of Life (CGQL) is a simpler tool, which has been validated in patients with ulcerative colitis undergoing restorative proctocolectomy. This study validates CGQL in patients with Crohn's disease and determines the correlation of QOL measurement systems with disease activity as measured by the Crohn's Disease Activity Index (CDAI). METHODS: All patients with Crohn's disease presenting to this department between September 2001 and February 2002 were prospectively entered into a database, including demographic data, disease manifestations, Vienna classification, age at diagnosis, and duration of Crohn's disease. SF-36, CGQL, and CDAI scores were entered concurrently. Cronbach's alpha was used to assess the internal consistency among the components of the CGQL score. Correlation among various QOL measures was assessed with Spearman's test. Relationships between QOL measures and various baseline factors were assessed by Wilcoxon rank sum test, Student's t test, Kruskal-Wallis test, and Pearson's test, depending on the type and distribution of data. Change from baseline in the CGQL was assessed with the Wilcoxon signed rank test. RESULTS: One hundred seventy-eight (178) patients were entered into the database, and 169 completed QOL and CDAI data. There was a significant correlation between SF-36 and CGQL. CGQL and SF-36 correlated similarly with CDAI. Neither patient age, gender, or smoking history were associated with CGQL. CONCLUSIONS: CGQL correlates with disease activity and is a simple measure of QOL in Crohn's disease.

Quality of life improves within 30 days of surgery for Crohn's disease.

BACKGROUND: The effect of surgery on quality of life (QOL) in the early postoperative period is important in Crohn's disease because of the multiple surgical procedures that patients undergo and the acute QOL benefits that might occur as a result of modifications of medical treatment. Earlier studies of the effect of surgery on QOL have been retrospective and assessed changes 3 to 24 months after surgery. This study prospectively assesses the effect of surgery on QOL in the early postoperative period. STUDY DESIGN: Patients requiring surgical management of sequelae of Crohn's disease were obtained from a prospectively entered database including data on QOL. Preoperative and 30-day postoperative QOL were determined in 82 patients using Cleveland Global Quality of Life (CGQL) scores (range from 0 [worst] to 10 [best possible] QOL). Preoperative and postoperative scores were compared using a paired t-test to determine the significance of any change in QOL after surgery. The effect of other variables on change in QOL after surgery was assessed using the t-test or analysis of variance. Multifactor analysis of variance was used to assess the effect of several independent variables. RESULTS: Eighty-two patients (41 women) of 142 patients who had had surgery (58%) had complete preoperative and 30-day postoperative scores. The incidence of complications was 23% (11% were major). There was a significant improvement in QOL 30 days after surgery as measured by CGQL (0.6 +/- 0.2 preoperative to 0.7 +/- 0.2 postoperative; mean +/- SD; p < 0.001). The mean preoperative CGQL was 0.56 +/- 0.24 and the mean improvement was 0.11 +/- 0.20 toward a better QOL. Female patients (p < 0.05) and those who did not develop complications within 30 days of surgery (p < 0.05) had a significantly greater improvement in CGQL after surgery than other groups. No other factor was predictive of improved outcomes. CONCLUSIONS: QOL as measured by CGQL improves early after surgery (30 days postoperatively). Improvement in CGQL is greater in female patients and patients who do not develop complications in the postoperative period. It is not affected by other patient characteristics, nature of disease, indication, or procedure performed. Most patients who undergo surgery for Crohn's disease feel that surgery has helped them and would undergo surgery again.