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

ABSTRACT: 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.

SUBMITTER: Hegland PA

PROVIDER: S-EPMC7311033 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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

Hegland Pål André PA Aasprang Anny A Kolotkin Ronette L RL Moltu Christian C Tell Grethe S GS Andersen John Roger JR

BMJ open 20200622 6

<h4>Background</h4>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).<h4>Aim</h4>We will explore patients' and healthcare professionals' experiences when a PRO/CFS is an integrated part of bariatric surgery care.<h4>Methods and analyses</h4>This is a design paper ...[more]

PMID: 32571865

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Project description:BACKGROUND:Obesity is recognized as a classic risk factor for atherosclerosis and subsequent cardiovascular disease (CVD). Weight loss after bariatric surgery has been associated with reduced CV mortality and total mortality in obese patients. Our aim was to study the impact of bariatric surgery on CV risk profile, cardiac structure, and function postoperatively. RESULTS:This prospective longitudinal study included 100 morbidly obese patients at final analysis. All patients were subjected to full clinical, laboratory, and echocardiographic examination at baseline and 6?months after bariatric surgery. The mean age of study population was 37.2 ± 10.49 with BMI of 47 ± 6.82. Females represented 84%. Sleeve gastrectomy and Roux-en-Y gastric bypass were performed in 79% and 21%, respectively. Surgery-related mortality and morbidity were 0.94% and 4.7%, respectively. After 6?months, there were significant decreases in BMI, heart rate, SBP, DBP, and Framingham risk score (P < 0.0001). The prevalence of risk factors decreased as follows: hypertension 24% vs. 12%, P = 0.0005; DM 21% vs. 11%, P = 0.002; dyslipidemia 32% vs. 7%, P < 0.0001; and metabolic syndrome 54% vs. 26%, P < 0.0001. Highly significant (P < 0.0001) decrease in fasting PG and 2?h PP-PG, HbA1c, ASL, ALT, fasting total cholesterol, LDL, TG, and increase in HDL were observed after bariatric surgery. There were significant shortening in QTc interval (P = 0.009), decrease in LV dimensions and LV mass index (P < 0.0001), and increase in LV EF% (P = 0.0003). BMI at follow-up showed significant positive correlation with age, Framingham risk score, and preoperative BMI (r = 0.289, P = 0.0036; r = 0.37, P = 0.0054; and r = 0.31, P = 0.0081, respectively). CONCLUSION:In addition to enabling patients to achieve a substantial weight loss, bariatric surgery provides a myriad of health benefits. Weight reduction was associated with a favorable improvement in cardiovascular risk profile, cardiac structure, and function.

Project description:BackgroundThe aim of this scoping review is to identify and summarize patient-reported outcome measures (PROMs) that are being used to track long-term patient-reported outcomes (PROs) after injury and can potentially be included in trauma registries.MethodsOnline databases were used to identify studies published between 2013 and 2019, from which we selected 747 articles that involved survivors of acute physical traumatic injury aged 18 years or older at time of injury and used PROMs to evaluate recovery between 6 months and 10 years postinjury. Data were extracted and summarized using descriptive statistics and a narrative synthesis of the results.ResultsMost studies were observational, with relatively small sample sizes, and predominantly on traumatic brain injury or orthopedic patients. The number of PROs assessed per study varied from one to 12, for a total of 2052 PROs extracted, yielding 74 unique constructs (physical health, 25 [34%]; mental health, 27 [37%]; social health, 12 [16%]; cognitive health, 7 [10%]; and quality of life, 3 [4%]). These 74 constructs were assessed using 355 different PROMs. Mental health was the most frequently examined outcome domain followed by physical health. Health-related quality of life, which appeared in more than half of the studies (n = 401), was the most common PRO evaluated, followed by depressive symptoms. Physical health was the domain with the highest number of PROMs used (n = 157), and lower-extremity functionality was the PRO that contributed most PROMs (n = 33).ConclusionWe identified a wide variety of PROMs available to track long-term PROs after injury in five different health domains: physical, mental, social, cognitive, and quality of life. However, efforts to fully understand the health outcomes of trauma patients remain inconsistent and insufficient. Defining PROs that should be prioritized and standardizing the PROMs to measure them will facilitate the incorporation of long-term outcomes in national registries to improve research and quality of care.Level of evidenceSystematic Reviews & Meta-analyses, Level IV.

Project description:BackgroundRobust data on patient-reported outcome measures comparing treatments for clinically localized prostate cancer are lacking. We investigated the effects of active monitoring, radical prostatectomy, and radical radiotherapy with hormones on patient-reported outcomes.MethodsWe compared patient-reported outcomes among 1643 men in the Prostate Testing for Cancer and Treatment (ProtecT) trial who completed questionnaires before diagnosis, at 6 and 12 months after randomization, and annually thereafter. Patients completed validated measures that assessed urinary, bowel, and sexual function and specific effects on quality of life, anxiety and depression, and general health. Cancer-related quality of life was assessed at 5 years. Complete 6-year data were analyzed according to the intention-to-treat principle.ResultsThe rate of questionnaire completion during follow-up was higher than 85% for most measures. Of the three treatments, prostatectomy had the greatest negative effect on sexual function and urinary continence, and although there was some recovery, these outcomes remained worse in the prostatectomy group than in the other groups throughout the trial. The negative effect of radiotherapy on sexual function was greatest at 6 months, but sexual function then recovered somewhat and was stable thereafter; radiotherapy had little effect on urinary continence. Sexual and urinary function declined gradually in the active-monitoring group. Bowel function was worse in the radiotherapy group at 6 months than in the other groups but then recovered somewhat, except for the increasing frequency of bloody stools; bowel function was unchanged in the other groups. Urinary voiding and nocturia were worse in the radiotherapy group at 6 months but then mostly recovered and were similar to the other groups after 12 months. Effects on quality of life mirrored the reported changes in function. No significant differences were observed among the groups in measures of anxiety, depression, or general health-related or cancer-related quality of life.ConclusionsIn this analysis of patient-reported outcomes after treatment for localized prostate cancer, patterns of severity, recovery, and decline in urinary, bowel, and sexual function and associated quality of life differed among the three groups. (Funded by the U.K. National Institute for Health Research Health Technology Assessment Program; ProtecT Current Controlled Trials number, ISRCTN20141297 ; ClinicalTrials.gov number, NCT02044172 .).

Project description:BACKGROUND:Patients with cystic fibrosis (CF) can struggle with burdensome symptoms and treatment regimens that negatively affect every aspect of their life. As physiological parameters can fail to capture these complications, the assessment of health-related quality of life (HRQOL) has gained prominence. HRQOL can be measured using standardized patient questionnaires called patient-reported outcome measures (PROMs). The Australian Cystic Fibrosis Data Registry (ACFDR) collects clinical data on adult and pediatric patients with CF. The incorporation of PROMs into the ACFDR would enable monitoring of HRQOL trends, benchmarking of HRQOL outcomes, and support of HRQOL research in CF. OBJECTIVE:Prior to incorporation of a PROM in the ACFDR, this systematic review was planned to evaluate whether any suitable PROMs are currently being used for CF. METHODS:This systematic review will be conducted in compliance with the PRISMA-P (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols) guidelines. MEDLINE, EMBASE, Scopus, CINAHL (Cumulative Index of Nursing and Allied Health Literature), PsycINFO, and Cochrane Library databases were searched for articles published between January 2009 and February 2019 on the use of PROMs to measure HRQOL in adult and pediatric patients with CF. Study designs such as observational studies, reviews and validation studies were included. Studies describing randomized controlled trials, dissertations, books, guideline statements, and abstracts were excluded. The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) risk of bias checklist was used to assess the methodological quality of included studies. A descriptive synthesis of the results will be undertaken in line with the outcomes of this study. RESULTS:As of July 2019, the search has been conducted and 4530 records were screened. After two phases of screening, 97 studies were included in the final review and subjected to data extraction. Reviewers are currently in the process of critical appraisal. CONCLUSIONS:This review will identify any PROM(s) that may be used to measure HRQOL in the ACFDR. TRIAL REGISTRATION:PROSPERO International Prospective Register of Systematic Reviews CRD42019126931; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=126931.

Dataset Information

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

Publications

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

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