Sensitivity for Change Analyses of the Patient-Reported Outcomes in Obesity (PROS) Questionnaire: A Prospective Cohort Study.

Purpose: Many patients seeking bariatric surgery experience reduced health-related quality of life (HRQOL). A simple clinical tool, the Patient-Reported Outcomes in Obesity (PROS), was developed to address patients' HRQOL concerns during clinical consultations and facilitate meaningful dialogue. The present study aims to explore its sensitivity to change. Patients and Methods: A prospective study of patients undergoing bariatric surgery was conducted. The patients responded to items on the PROS and the Obesity-related Problems Scale (OP) before surgery and three, 12 and 24 months after surgery. Longitudinal mixed-effects models were applied to estimate the change in PROS and OP scores over time. Results: Thirty-eight patients were included. A significant change over time was detected for the PROS with the largest effect size at 24 months (effect size -1.34, p ˂ 0.001), while the corresponding effect size for the OP was -1.32 (p ˂ 0.001). In all items of the PROS, the majority of patients responded not bothered at 24 months. The items physical activity, pain, sleep and self-esteem showed the largest change in the percentage of patients reporting not bothered from baseline to 24 months after surgery. Conclusion: The PROS is sensitive to change over time and may be used as a brief, easy to administer tool to facilitate a conversation about obesity-specific quality of life in clinical consultations.

A novel patient-reported outcome monitoring with clinical feedback system in bariatric surgery care: study protocol, design and plan for evaluation.

BACKGROUND: Consultations before and after bariatric surgery should include structured assessments of patients' health-related quality of life (HRQOL) and mental health. One way to conduct this assessment is to implement patient-reported outcome monitoring with a clinical feedback system (PRO/CFS). AIM: We will explore patients' and healthcare professionals' experiences when a PRO/CFS is an integrated part of bariatric surgery care. METHODS AND ANALYSES: This is a design paper in which a PRO/CFS will be implemented in two bariatric outpatient clinics. All patients who have an appointment with a healthcare professional prior to, and 3 and 12 months after surgery, will be asked to complete six digital questionnaires measuring HRQOL, mental health, bowel symptoms and eating self-efficacy prior to each consultation. A digital summary report generated from the patient's responses will form the basis for the clinical consultation. A team of patient representatives, healthcare professionals and researchers will be involved in all phases of designing the PRO/CFS to ensure its relevance for clinical consultations. The patients' experiences will be explored with a generic 12-item questionnaire, developed for use in outpatient clinics, prior to and 12 months after bariatric surgery. We will conduct focus-group interviews with patients and healthcare professionals to explore their experiences when PRO/CFS is integrated into the consultations. ETHICS AND DISSEMINATION: Written informed consent will be obtained for all participants in the study. The project is approved by the Norwegian Centre for Research Data, Department of Data Protection Services (ref. no. 282738). The project has also undergone Data Protection Impact Assessments, both at Førde Hospital Trust and at St. Olav Hospital (registration no. 2016/3912). Data from the qualitative and quantitative studies will be kept in de-identified form in a secured research database, and the findings will be published in international peer-reviewed journals and presented at scientific conferences.

Overall Treatment Satisfaction 5 Years After Bariatric Surgery.

INTRODUCTION: Up to 30 % of patients undergoing bariatric surgery are dissatisfied with treatment outcomes in the long term. The aim of this study was to examine overall satisfaction with treatment 5 years after bariatric surgery and its association with body mass index (BMI) and health-related quality of life (HRQOL). METHODS: Patients were surveyed 5 years after bariatric surgery; 108 patients had duodenal switch (DS) and 153 patients had laparoscopic sleeve gastrectomy (LSG). The main outcome was overall treatment satisfaction, assessed by a single question, and analyzed by multiple logistic regression. Estimates for continuous independent variables represent the odds ratios (OR) for a 2-standard deviation difference. RESULTS: Five years after surgery, 82.4 % of the patients were very satisfied or satisfied, whereas 17.6 % were unsure or dissatisfied. The following variables assessed at 5 years were associated with being dissatisfied/unsure: a higher BMI (OR = 6.1, 95 % CI = 2.7-14.0, p < 0.001), reduced obesity-specific HRQOL (OR = 3.0, 95 % CI = 1.1-7.8, p = 0.03), and reduced mental HRQOL (OR = 0.3, 95 % CI = 0.1-0.8, p = 0.02). We also found that a higher proportion of patients who underwent LSG, compared to DS, reported being dissatisfied/unsure (OR = 3.3, 95 % CI = 1.3-8.8, p = 0.01). CONCLUSION: Reduced mental HRQOL and obesity-related HRQOL, as well as higher BMI, were associated with less satisfaction with overall treatment outcomes 5 years after bariatric surgery. Differences in overall treatment satisfaction by type of operation warrant further investigation.

Patient-reported quality of life with obesity - development of a new measurement scale. / Pasientrapportert livskvalitet ved fedme ­ utvikling av nytt måleinstrument.

BACKGROUND: Many questionnaires for measuring the quality of life for patients with obesity require comprehensive calculation before they are used. There is a need for questionnaires that permit simple assessment of the responses during a patient consultation. We have developed the questionnaire Patient-Reported Outcomes in Obesity (PROS). The objective of the study was to test the reliability and validity of the questionnaire. MATERIAL AND METHOD: The questionnaire was used to ask patients about the extent to which they perceived their weight or body shape as bothersome. A group of patients with an average body mass index (BMI) of 42 (n = 109) completed the PROS questionnaire and The Impact of Weight Quality of Life questionnaire (IWQOL-Lite) before undergoing obesity surgery. Another group with an average body mass index of 29 (n = 95) completed the PROS questionnaire 1-5 years after having undergone obesity surgery. 67,7 % of the patients were > 40 years and 79 % were women. For the statistical analysis we used Cronbach's alpha, factor analysis, Spearman's rank test and independent t-test. RESULTS: Cronbach's alpha for the total PROS score was 0.90, and the factor analysis showed a significant factor (eigenvalue = 4.7) that explained 58.4 % of the variance. The test-retest correlation was 0.93 (p < 0.001). The correlation coefficients between the PROS score, the total IWQOL-Lite score (rs = -0.91) and body mass index (rs = 0.60) were all significant (p < 0.001). The t-test showed an effect size (difference in standard deviation) between the non-surgery and the surgery groups of 1.9 (95 % CI 1.6-2.5) for the PROS questionnaire and 2.1 (95 % CI 1.7-2.5 for the total IWQOL-Lite score. INTERPRETATION: The PROS questionnaire is a reliable and valid questionnaire for measurement of obesity-specific quality of life.