scholarly journals Patient-Reported Outcomes for Quality of Life in SLE: Essential in Clinical Trials and Ready for Routine Care

2021 ◽  
Vol 10 (16) ◽  
pp. 3754
Author(s):  
Matthew H. Nguyen ◽  
Frank F. Huang ◽  
Sean G. O’Neill
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Lupus Erythematosus ◽  
Clinical Care ◽  
Routine Care ◽  
Patient Reported Outcome ◽  
Current Evidence ◽  
Patient Reported ◽  
Pro Tools

Patient-reported outcome (PRO) instruments are widely used to assess quality of life in Systemic Lupus Erythematosus (SLE) research, and there is growing evidence for their use in clinical care. In this review, we evaluate the current evidence for their use in assessing quality of life in SLE in both research and clinical settings and examine the different characteristics of the commonly used PRO tools. There are now several well-validated generic and SLE-specific tools that have demonstrated utility in clinical trials and several tools that complement activity and damage measures in the clinical setting. PRO tools may help overcome physician–patient discordance in SLE and are valuable in the assessment of fibromyalgia and type 2 symptoms such as widespread pain and fatigue. Future work will identify optimal PRO tools for different settings but, despite current limitations, they are ready to be incorporated into patient care.

scholarly journals AB0300 LUPUS DISEASE ACTIVITY CORRELATES WITH QUALITY OF LIFE BUT NOT WITH HEALTH LITERACY STATUS

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1176.2-1176
Author(s):  
E. Eraslan ◽  
R. Bilici Salman ◽  
H. Satiş ◽  
A. Avanoglu Guler ◽  
H. Karadeniz ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Health Literacy ◽  
Disease Activity ◽  
Lupus Erythematosus ◽  
Patient Reported Outcome ◽  
The Body ◽  
Limited Health Literacy ◽  
Patient Reported ◽  
Limited Health

Background:Systemic lupus erythematosus (SLE) is a chronic autoimmune disease of unknown etiology that can affect any organ of the body. SLE is associated with adverse effects on both health and non-health-related quality of life (HRQOL and non-HRQOL). Lupus PRO is a patient reported outcome measure that has been validated in many languages. It has 44 items that cover both HRQOL and non-HRQOL (1). Health literacy is defined as the degree to which individuals have the capacity to obtain, process and understand basic health information and services needed to make appropriate health decisions. Multiple studies indicate that people with limited health literacy have worse health status and higher rates of hospitalization (2).Objectives:We aimed to evaluate the relationship between the LLDAS (Lupus Low Disease Activity State) criteria and the Lupus PRO test, as well as the health literacy status of lupus patients.Methods:83 SLE patients (94% women) were included in the study. We performed Lupus PRO and the European Health Literacy Survey tests during the routine follow-up visits of lupus patients to our rheumatology outpatient clinic and admissions to rheumatology inpatient clinic. Available clinical data on medical records were obtained, physician global assessments (PGA) were recorded by the attending physician.Results:LLDAS criteria strongly and inversely correlated with the total score, as well as the mood subunit of the Lupus PRO. Similarly, it also significantly inversely correlated with the body appearence and goals subunits. Health literacy status of the patients did not correlate with their LLDAS scores, ie their disease activities.Conclusion:Our results suggest that lupus disease activity, assessed by LLDAS criteria, significantly correlates with measures of quality of life, spesicifically Lupus PRO test, but not with health literacy status. Further studies are needed to evaluate if health literacy is related with damage, hospitalization or mortality associated with lupus.References:[1]Jolly M, Pickard AS, Block JA, Kumar RB, Mikolaitis RA, Wilke CT, et al., editors. Disease-specific patient reported outcome tools for systemic lupus erythematosus. Seminars in arthritis and rheumatism; 2012: Elsevier.[2]Paasche-Orlow MK, Parker RM, Gazmararian JA, Nielsen-Bohlman LT, Rudd RR. The prevalence of limited health literacy. Journal of general internal medicine. 2005;20(2):175-84.Disclosure of Interests:None declared

scholarly journals Patient-Reported Outcomes in Metastatic Breast Cancer: A Review of Industry-Sponsored Clinical Trials

2016 ◽  
Vol 10 ◽  
pp. BCBCR.S39385 ◽  
Author(s):  
Meaghan Krohe ◽  
Yanni Hao ◽  
Roger E. Lamoureux ◽  
Nina Galipeau ◽  
Denise Globe ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Clinical Trials ◽  
Metastatic Breast Cancer ◽  
Metastatic Breast ◽  
Patient Reported Outcome ◽  
Primary Study ◽  
Successful Implementation ◽  
Patient Reported

Introduction Patient-reported outcome (PRO) measures serve to capture vital patient information not otherwise obtained by primary study endpoints. This paper examines how PROs are utilized as endpoints in industry-sponsored metastatic breast cancer clinical trials. Methods A search was conducted in the clinicaltrials.gov web site for trials involving common treatments for metastatic breast cancer. Thirty-eight clinical trials were identified which included a PRO endpoint in the study, and data were extracted and summarized. Results Overall, 17 unique PRO questionnaires and 14 concepts of measurement were identified as secondary or exploratory endpoints. The Functional Assessment of Cancer Therapy—Breast was the most frequently utilized questionnaire, commonly implemented to assess quality of life. The EORTC QLQ-C30 was also frequently used to measure quality of life or pain. Conclusion This review shares insights into the role of PROs in trials for metastatic breast cancer from which treatment developers and other stakeholders can enhance successful implementation of the patient voice into future trials.

scholarly journals [REiNS] Current Recommendations for Patient-Reported Outcome Measures Assessing Domains of Quality of Life in Neurofibromatosis Clinical Trials

Neurology ◽  
2021 ◽  
pp. 10.1212/WNL.0000000000012421
Author(s):  
Pamela L. Wolters ◽  
Ana-Maria Vranceanu ◽  
Heather L. Thompson ◽  
Staci Martin ◽  
Vanessa Leigh Merker ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Neurofibromatosis Type ◽  
Patient Reported Outcome ◽  
Self Report ◽  
World Health ◽  
World Health Organization Quality ◽  
Patient Reported ◽  
Disease Specific

Objective:To review and recommend patient-reported outcome (PRO) measures assessing multidimensional domains of quality of life (QOL) to use as clinical endpoints in medical and psychosocial trials for children and adults with neurofibromatosis type 1 (NF1), neurofibromatosis type 2 (NF2), and schwannomatosis.Methods:The PRO working group of the Response Evaluation in Neurofibromatosis and Schwannomatosis (REiNS) International Collaboration used systematic methods to review, rate, and recommend existing self-report and parent-report PRO measures of generic and disease-specific QOL for neurofibromatosis (NF) clinical trials. Recommendations were based on four main criteria: patient characteristics, item content, psychometric properties, and feasibility.Results:The highest rated generic measures were 1) the Pediatric Quality of Life Inventory (PedsQL™) Generic Core Scales for NF clinical trials for children or for children through adults, 2) the Functional Assessment of Cancer Therapy-General (FACT-G) for adult medical trials, and 3) the World Health Organization Quality of Life-BREF (WHOQOL-BREF) for adult psychosocial trials. The highest rated disease-specific measures were 1) the PedsQL NF1 Module for NF1 trials, 2) the NF2 Impact on Quality of Life (NFTI-QOL) Scale for NF2 trials, and 3) the Penn Acoustic Neuroma Quality of Life (PANQOL) Scale for NF2 trials targeting vestibular schwannomas. To date, there are no disease-specific tools assessing multidimensional domains of QOL for schwannomatosis.Conclusions:The REiNS Collaboration currently recommends these generic and disease-specific PRO measures to assess multidimensional domains of QOL for NF clinical trials. Additional research is needed to further evaluate the use of these measures in both medical and psychosocial trials.

scholarly journals Moving forward toward standardizing analysis of quality of life data in randomized cancer clinical trials

2018 ◽  
Vol 15 (6) ◽  
pp. 624-630 ◽  
Author(s):  
Andrew Bottomley ◽  
Madeline Pe ◽  
Jeff Sloan ◽  
Ethan Basch ◽  
Franck Bonnetain ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Patient Reported Outcomes ◽  
Patient Reported Outcome ◽  
Outcome Data ◽  
Patient Reported ◽  
Related Quality ◽  
Health Related ◽  
Guidelines And Recommendations

Background There is currently a lack of consensus on how health-related quality of life and other patient-reported outcome measures in cancer randomized clinical trials are analyzed and interpreted. This makes it difficult to compare results across randomized controlled trials (RCTs) synthesize scientific research, and use that evidence to inform product labeling, clinical guidelines, and health policy. The Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data for Cancer Clinical Trials (SISAQOL) Consortium aims to develop guidelines and recommendations to standardize analyses of patient-reported outcome data in cancer RCTs. Methods and Results Members from the SISAQOL Consortium met in January 2017 to discuss relevant issues. Data from systematic reviews of the current state of published research in patient-reported outcomes in cancer RCTs indicated a lack of clear reporting of research hypothesis and analytic strategies, and inconsistency in definitions of terms, including “missing data,”“health-related quality of life,” and “patient-reported outcome.” Based on the meeting proceedings, the Consortium will focus on three key priorities in the coming year: developing a taxonomy of research objectives, identifying appropriate statistical methods to analyze patient-reported outcome data, and determining best practices to evaluate and deal with missing data. Conclusion The quality of the Consortium guidelines and recommendations are informed and enhanced by the broad Consortium membership which includes regulators, patients, clinicians, and academics.

Adaptation and cross-cultural validation of the Spanish version of the Thyroid-Related Quality-of-Life Patient-Reported Outcome (ThyPRO) questionnaire

2018 ◽  
Author(s):  
Lleo Ana Maria Gonzalez ◽  
Mauro Boronat Cortes ◽  
Ulla Feldt-Rasmussen ◽  
Carlos Rodriguez Perez ◽  
AEse Krogh Rasmussen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Patient Reported Outcome ◽  
Cross Cultural ◽  
Spanish Version ◽  
Patient Reported ◽  
Related Quality ◽  
Cultural Validation

scholarly journals An assessment of the use of patient reported outcome measurements (PROMs) in cancers of the pelvic abdominal cavity: identifying oncologic benefit and an evidence-practice gap in routine clinical practice

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Miss Charlotte L. Moss ◽  
Ajay Aggarwal ◽  
Asad Qureshi ◽  
Benjamin Taylor ◽  
Teresa Guerrero-Urbano ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Systematic Review ◽  
Abdominal Cavity ◽  
Patient Reported Outcome ◽  
Oncologic Outcomes ◽  
Review Of The Literature ◽  
Outcome Measurements ◽  
Patient Reported ◽  
Cancer Setting

Abstract Background Patient reported outcome measurements (PROMs) are emerging as an important component of patient management in the cancer setting, providing broad perspectives on patients’ quality of life and experience. The use of PROMs is, however, generally limited to the context of randomised control trials, as healthcare services are challenged to sustain high quality of care whilst facing increasing demand and financial shortfalls. We performed a systematic review of the literature to identify any oncological benefit of using PROMs and investigate the wider impact on patient experience, in cancers of the pelvic abdominal cavity specifically. Methods A systematic review of the literature was conducted using MEDLINE (Pubmed) and Ovid Gateway (Embase and Ovid) until April 2020. Studies investigating the oncological outcomes of PROMs were deemed suitable for inclusion. Results A total of 21 studies were included from 2167 screened articles. Various domains of quality of life (QoL) were identified as potential prognosticators for oncologic outcomes in cancers of the pelvic abdominal cavity, independent of other clinicopathological features of disease: 3 studies identified global QoL as a prognostic factor, 6 studies identified physical and role functioning, and 2 studies highlighted fatigue. In addition to improved outcomes, a number of included studies also reported that the use of PROMs enhanced both patient-clinician communication and patient satisfaction with care in the clinical setting. Conclusions This review highlights the necessity of routine collection of PROMs within the pelvic abdominal cancer setting to improve patient quality of life and outcomes.

scholarly journals Measurement properties of patient-reported outcome measures (PROMs) in hyperhidrosis: a systematic review

2021 ◽  
Author(s):  
Michaela Gabes ◽  
Helge Knüttel ◽  
Gesina Kann ◽  
Christina Tischer ◽  
Christian J. Apfelbacher
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Measurement Properties ◽  
High Quality ◽  
High Quality Evidence ◽  
Patient Reported ◽  
Quality Evidence

Abstract Purpose To critically appraise, compare and summarize the quality of all existing PROMs that have been validated in hyperhidrosis to at least some extend by applying the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology. Thereby, we aim to give a recommendation for the use of PROMs in future clinical trials in hyperhidrosis. Methods We considered studies evaluating, describing or comparing measurement properties of PROMs as eligible. A systematic literature search in three big databases (MEDLINE, EMBASE and Web of Science) was performed. We assessed the methodological quality of each included study using the COSMIN Risk of Bias checklist. Furthermore, we applied predefined quality criteria for good measurement properties and finally, graded the quality of the evidence. Results Twenty-four articles reporting on 13 patient-reported outcome measures were included. Three instruments can be further recommended for use. They showed evidence for sufficient content validity and moderate- to high-quality evidence for sufficient internal consistency. The methodological assessment showed existing evidence gaps for eight other PROMs, which therefore require further validation studies to make an adequate decision on their recommendation. The Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) and the short-form health survey with 36 items (SF-36) were the only questionnaires not recommended for use in patients with hyperhidrosis due to moderate- to high-quality evidence for insufficient measurement properties. Conclusion Three PROMs, the Hyperhidrosis Quality of Life Index (HidroQoL), the Hyperhidrosis Questionnaire (HQ) and the Sweating Cognitions Inventory (SCI), can be recommended for use in future clinical trials in hyperhidrosis. Results obtained with these three instruments can be seen as trustworthy. Nevertheless, further validation of all three PROMs is desirable. Systematic review registration PROSPERO CRD42020170247

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