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A Novel Patient-Reported Outcome-Based Evaluation (PROBE) of Quality of Life in Patients With Inflammatory Bowel Disease.

ABSTRACT: OBJECTIVES:There is increased interest in measuring patient-reported outcomes (PROs) such as quality of life (QoL) among patients with inflammatory bowel disease (IBD). We aimed to create and validate a new measure of QoL to assess the psychosocial burden of IBD using publicly available assessment tools. METHODS:Using the Crohn's & Colitis Foundation's IBD Partners cohort, we performed several cross-sectional and longitudinal analyses to create a new PRO-based evaluation (PROBE) of QoL among patients with Crohn's disease (CD) and ulcerative colitis (UC). We used factor analysis and Pearson correlation test to identify candidate questions for inclusion, Wilcoxon rank-sum test to examine responsiveness of the PROBE to changes in disease activity, and test-retest reliability assessments in patients with stable disease activity. We also compared the PROBE to the Short Inflammatory Bowel Disease Questionnaire to assess construct validity. RESULTS:A total of 4,854 patients (64% CD, 36% UC) completed surveys with 6 items included in the final PROBE. Compared with baseline there was a significant decrease in PROBE scores at follow-up among patients who experienced a flare for UC (25.0 vs 22.2, P = 0.001) and CD (23.1 vs 21.0, P < 0.001). Among patients with stable disease activity, Cronbach alpha was 0.87 in CD and 0.82 in UC. The PROBE correlated well with the Short Inflammatory Bowel Disease Questionnaire in CD (r = 0.88) and UC (r = 0.86). DISCUSSION:We created a novel measure to assess QoL in patients with IBD using publicly available survey items. This new PROBE can be used to facilitate clinical care, clinical and epidemiological research, and quality improvement.

SUBMITTER: Barnes EL

PROVIDER: S-EPMC6450720 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature

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A Novel Patient-Reported Outcome-Based Evaluation (PROBE) of Quality of Life in Patients With Inflammatory Bowel Disease.

Barnes Edward L EL Kappelman Michael D MD Long Millie D MD Evon Donna M DM Martin Christopher F CF Sandler Robert S RS

The American journal of gastroenterology 20190401 4

<h4>Objectives</h4>There is increased interest in measuring patient-reported outcomes (PROs) such as quality of life (QoL) among patients with inflammatory bowel disease (IBD). We aimed to create and validate a new measure of QoL to assess the psychosocial burden of IBD using publicly available assessment tools.<h4>Methods</h4>Using the Crohn's & Colitis Foundation's IBD Partners cohort, we performed several cross-sectional and longitudinal analyses to create a new PRO-based evaluation (PROBE) o ...[more]

PMID: 30848727

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Project description:Background & Aims:Non-alcoholic steatohepatitis (NASH) is known to have a negative impact on patients' health-related quality of life (HRQoL), even before progression to cirrhosis has occurred. The burden of NASH-related cirrhosis from the patient perspective remains poorly understood. Herein, we aimed to identify the burden of disease and HRQoL impairment among patients with NASH-related compensated cirrhosis. Methods:This targeted literature review sought first to identify the humanistic burden of disease from the perspective of patients with diagnosed NASH-cirrhosis and, secondly, to identify generic or disease-specific patient-reported outcome measures (PROMs) used to assess the impact of NASH-cirrhosis. Searches were conducted in bibliographical databases, grey or unpublished literature, liver disease websites, support group websites and online blogs. A quality assessment of specific PROMs was conducted. Results:Patients with NASH-cirrhosis are reported to suffer from lower HRQoL than patients with non-cirrhotic NASH and the general population with respect to physical health/functioning, emotional health and worry, and mental health. Thirteen PROMs were identified, of which 4 were liver-disease specific: CLDQ, CLDQ-NAFLD, LDQoL and LDSI. The most commonly used measures do not comply with current industry or regulatory standards for PROMs and/or are not validated for use in a cirrhotic NASH population. Conclusions:Patients with NASH-cirrhosis have lower HRQoL and poorer physical health than patients with non-cirrhotic NASH. However, the literature lacked detail of the everyday impact on patients' lives. Currently, a number of PROMs are available to measure the impact of the disease in patients with chronic liver conditions. The lack of studies that include qualitative insights in this population mandates further exploration and research. Lay summary:It is not well understood how having non-alcoholic fatty liver disease (NAFLD)-related cirrhosis affects a person's everyday wellbeing and quality of life. Some research has been done with patients who have early stages of liver disease but not people with cirrhosis. We found that patients with NAFLD-related cirrhosis tended to have poorer health than patients without cirrhosis. But there was not very much information from patients themselves and there were no tools or questionnaires just for this group of patients.

Project description:BackgroundInfertility has a negative impact on quality of life (QoL) and well-being of affected individuals and couples. A variety of patient-reported outcome (PRO) measures to assess infertility-related QoL are available; however, there is a concern regarding potential issues with their development methodology, validation and use. This review aimed to i) identify PRO measures used in infertility interventional studies ii) assess validation evidence to identify a reliable, valid PRO measure to assess changes in QoL or treatment satisfaction in clinical studies with female patients following treatment with novel therapies iii) identify potential gaps in evidence for validity.MethodsA structured literature search of Medline, Embase, and the Cochrane Library (accessed in September 2015) was conducted using pre-defined search terms. The identified publications were reviewed applying eligibility criteria to select interventional female infertility studies using PROs. Infertility-specific PRO measures assessing QoL, treatment satisfaction or psychiatric health, and included in studies by ≥2 research groups were selected and critically reviewed in light of scientific and regulatory guidance (e.g. FDA PRO Guidance for Industry) for evidence of content validity, psychometric strength, and patient acceptability.ResultsThe literature search and hand-searching yielded 122 publications; 78 unique PRO measures assessing QoL, treatment satisfaction or psychiatric health were identified. Five PRO measures met the selection criteria for detailed review: Fertility Quality of Life (FertiQoL); Fertility Problem Inventory (FPI); Fertility Problem Stress (FPS); Infertility Questionnaire (IFQ); Illness Cognitions Questionnaire adapted for Infertility (ICQ-I). None of the PRO measures met all validation criteria. The FertiQoL was the most widely used infertility-specific PRO measure to assess QoL in interventional studies, with reasonable evidence for adequate content validity, psychometric strength, and linguistic validation. However, gaps in evidence remain including test-retest reliability and thresholds for interpreting clinically important changes. While the FPI demonstrated reasonable evidence for content and psychometric validity, its utility as an outcome measure is limited by a lack of recall period.ConclusionThe FertiQoL and the FPI are potentially useful measures of infertility-related QoL in interventional studies. Further research is recommended to address gaps in evidence and confirm both PRO measures as reliable assessments of patient outcomes.

Project description:TopicSeveral patient-reported outcome measures (PROMs) are available to measure health-related quality of life (HRQoL) in patients with late-stage clinical diabetic retinal diseases (DRDs). However, an understanding of the psychometric properties of PROMs is needed to assess how they could relate to severity levels of a revised DRD grading system. This narrative review assessed the available generic-, vision-, and DRD-related PROMs used in DRD research and highlights areas for improvement.Clinical relevanceDiabetic retinal disease is a common complication of diabetes and can lead to sight-threatening complications with a devastating effect on HRQoL.MethodsThe Quality of Life working group is one of 6 working groups organized for the DRD Staging System Update Effort, a project of the Juvenile Diabetes Research Foundation Mary Tyler Moore Vision Initiative. PubMed, Cochrane Library, Embase, and Google Scholar databases were searched using core keywords to retrieve ophthalmology-related review articles, randomized clinical trials, and prospective, observational, and cross-sectional studies in the English language. A detailed review of 12 PROMs (4 QoL questionnaires and 8 utilities) that met a minimum level of evidence (LOE) was conducted. The relevance of each PROM to DRD disease stage and Biomarker Qualification guidelines (Biomarkers, EndpointS, and other Tools) categories was also defined.ResultsThe National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25), Impact of vision impairment-computerized adaptive testing, and Diabetic Retinopathy and Macular Edema Computerized Adaptive Testing System had a LOE of II in detecting change due to late-stage DRD (diabetic macular edema), although several areas for improvement (e.g., psychometrics and generalizability) were identified. Other PROMs, particularly the utilities, had a LOE of III due to cross-sectional evidence in late-stage clinical DRD. Although the NEI VFQ-25 has been the most widely used PROM in late-stage DRD, more work is required to improve its multidimensional structure and other psychometric limitations. No PROM was deemed relevant for subclinical or early/mid-DRD.ConclusionThis narrative review found that the most commonly used PROM is NEI VFQ-25, but none meets the ideal psychometric, responsiveness, and clinical setting digital administration requirements that could be included in an updated DRD staging system for diagnosis and monitoring of DRD progression.Financial disclosuresProprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Project description:Objective or purposeTo develop and test a patient-reported outcome measure for assessing health-related quality of life (HRQOL) in surgically amenable epiphora.DesignQuestionnaire development and validation study.Participants201 patients with a cause of epiphora amenable to surgical intervention, recruited across three independent centres.Methods, intervention or testingThe watery eye quality of life (WEQOL) questionnaire was developed and refined according to defined psychometric standards. Both surgical and non-surgical participants completed WEQOL at baseline and follow-up (>3 months), along with the Lacrimal Symptom Questionnaire (Lac-Q), RAND Short Form Health Survey (SF-36) and Glasgow Benefit Inventory (GBI). Convergent validity of WEQOL was evaluated according to correlation (R > 0.40) with each of these additional tests. Responsiveness of WEQOL to intervention was evaluated according to patient-reported success. Test-retest reliability was assessed by the Bland-Altman method and intraclass correlation (ICC) in a subset of 64 participants at baseline.Main outcome measuresWEQOL construct validity, responsiveness and test-retest reliability.ResultsWEQOL was moderately correlated (R > 0.4) with the Lac-Q and several subscales of the SF-36 (physical role limitation, social, emotional role limitation and emotional well-being). A stronger correlation was found between the change in WEQOL at follow-up and GBI (R = 0.61). An appropriate graded response was found with a significant change in WEQOL score being observed in patients reporting successful (-28%, p < 0.0001) and partially successful surgery (-6%, p = 0.04), but not in those reporting unsuccessful surgery (+2%, p = 0.9). High test-retest reliability was observed (ICC = 0.93).ConclusionsThe WEQOL questionnaire has been developed systematically according to modern psychometric standards and has been designed to evaluate the quality of life in patients with epiphora that is of a surgically amenable cause. In this study, it has demonstrated appropriate test-retest reliability, responsiveness and construct validity.

Project description:BackgroundDigital patient reported outcomes are used increasingly in daily care and treatment of inflammatory bowel disease. Their purpose includes increased focus on patient wellbeing, reduction in avoidable follow-up consultations and increased patient self-management. However, implementation issues occur and studies indicate patients may have concerns, particularly regarding having fewer face-to-face consultations. This study aims to explore patients' perspectives of use and non-use of digital patient reported outcomes and to understand the mechanisms underpinning patient reluctance to engage with this health technology.ResultsSixteen patients with inflammatory bowel disease at a regional hospital in Denmark were interviewed about their experiences of, and perspectives on, digital patient reported outcomes. A certain level of eHealth literacy was found to be a fundamental condition for use, while other factors were barriers or facilitators for use of digital PROs. Patients' main concerns were about potential consequences for their care and relationship with the clinic. Most patients in stable remission were satisfied with the hospital being a "life-line" if their symptoms worsened, and perceived digital patient reported outcomes to be an efficient tool to establish that "life-line". Patients with severe symptoms and a high degree of emotional distress related to their disease valued the potential for digital patient reported outcomes to increase their clinicians' focus on mental health and extra-intestinal symptoms.ConclusionThis study found that if patients had sufficient digital literacy, they perceived digital patient reported outcomes to be a useful replacement for face-to-face consultations. However, they were concerned about digital patient reported outcomes' effect on the patient-clinician relationship and its ability to detect worsening of symptoms. These concerns may be mitigated by good patient-clinician relationships, and the option for patients to maintain direct telephone contact with their gastroenterology specialist.

Dataset Information

A Novel Patient-Reported Outcome-Based Evaluation (PROBE) of Quality of Life in Patients With Inflammatory Bowel Disease.

Publications

A Novel Patient-Reported Outcome-Based Evaluation (PROBE) of Quality of Life in Patients With Inflammatory Bowel Disease.

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