scholarly journals Comparing the use of patient-reported outcomes in clinical studies in Europe in 2008 and 2018: a literature review

2021 ◽  
Author(s):  
Guro Lindviksmoen Astrup ◽  
Gudrun Rohde ◽  
Stein Arne Rimehaug ◽  
Marit Helen Andersen ◽  
Tomm Bernklev ◽  
...  
Keyword(s):  
Full Text ◽  
Clinical Studies ◽  
Patient Reported Outcomes ◽  
Key Characteristics ◽  
Patient Reported ◽  
Full Text Review ◽  
Patient Groups ◽  
Number Of Publications ◽  
Study Designs ◽  
Pro Instruments

Abstract Purpose Several guidelines for the use of patient-reported outcomes (PROs) in clinical studies have been published in the past decade. This review primarily aimed to compare the number and compliance with selected PRO-specific criteria for reporting of clinical studies in Europe using PROs published in 2008 and 2018. Secondarily, to describe the study designs, PRO instruments used, patient groups studied, and countries where the clinical studies were conducted. Methods A literature search was conducted in MEDLINE to identify eligible publications. To assess the number of publications, all abstracts were screened for eligibility by pairs of reviewers. Compliance with PRO-specific criteria and other key characteristics was assessed in a random sample of 150 eligible full-text publications from each year. Randomized controlled trials (RCTs) were assessed according to the full CONSORT-PRO checklist. Results The search identified 1692 publications in 2008 and 4290 in 2018. After screening of abstracts, 1240 from 2008 and 2869 from 2018 were clinical studies using PROs. By full-text review, the proportion of studies discussing PRO-specific limitations and implications was higher in 2018 than in 2008, but there were no differences in the other selected PRO-specific criteria. In 2018, a higher proportion of studies were longitudinal/cohort studies, included ≥ 300 patients, and used electronic administration of PRO than in 2008. The most common patient groups studied were those with cancer or diseases of the musculoskeletal system or connective tissue. Conclusion The number of clinical studies from Europe using PROs was higher in 2018 than in 2008, but there was little difference in compliance with the PRO-specific criteria. The studies varied in terms of study design and PRO instruments used in both publication years.

scholarly journals LB755 Patient-reported outcomes with sarecycline treatment for Acne Vulgaris: Pooled analysis of phase 3 clinical studies

2021 ◽  
Vol 141 (9) ◽  
pp. B12
Author(s):  
J. Harper ◽  
A. Armstrong ◽  
R. Fried ◽  
E. Rieder ◽  
A. Alvarez-Dieppa ◽  
...  
Keyword(s):  
Clinical Studies ◽  
Patient Reported Outcomes ◽  
Acne Vulgaris ◽  
Pooled Analysis ◽  
Phase 3 ◽  
Patient Reported

scholarly journals Disablement Model and Health-Related Quality of Life Classification for Patient-Reported Outcomes Measurement Information System (PROMIS) Instruments

2018 ◽  
Vol 53 (12) ◽  
pp. 1206-1213 ◽  
Author(s):  
Alison R. Snyder Valier ◽  
Cailee E. Welch Bacon ◽  
Kenneth C. Lam
Keyword(s):  
Patient Reported Outcomes ◽  
Measurement Information ◽  
Health Related Quality ◽  
Outcomes Measurement ◽  
Patient Reported ◽  
Related Quality ◽  
Health Related ◽  
Measurement Information System ◽  
Pro Instruments

ContextThe National Institutes of Health created a medical research road map that included the development of the Patient-Reported Outcomes Measurement Information System (PROMIS). A key feature of PROMIS was the development of patient-reported outcome measures (PROs) addressing various aspects of health. Understanding disablement dimensions and health-related quality-of-life (HRQOL) domains captured through PROMIS measures will help with instrument selection.ObjectiveTo evaluate the pediatric PROMIS PROs and determine the areas of disablement and HRQOL captured within each instrument.DesignDescriptive laboratory study.SettingLaboratory.Patients or Other ParticipantsTwenty-two pediatric PROMIS instruments (19 short forms and 3 profiles).Main Outcome Measure(s)Three raters independently reviewed the PROMIS instruments and categorized each question on each instrument according to the World Health Organization's International Classification of Functioning, Disability, and Health disablement model domains (body functions and structures, activity, participation, environmental factors, personal factors) and HRQOL (psychological, physical, social, spiritual, economic) dimensions. A consensus process determined the final question category. The frequencies of disablement model domains and HRQOL dimensions captured by questions on PROMIS instruments were reported.ResultsThe most frequently reported disablement model domain was body function and structure, which was captured by questions in 16/22 (73%) pediatric PROMIS instruments, followed by activity (13/22 [59%] pediatric PROMIS instruments) and participation (9/22 [41%] pediatric PROMIS instruments). The most frequently captured HRQOL dimensions were physical and psychological health, both evaluated in 13/22 (59%) of the pediatric PROMIS instruments. The social dimension of HRQOL was assessed in 9/22 (41%) of the pediatric PROMIS instruments.ConclusionsPediatric PROMIS fixed-length instruments captured a variety of disablement domains and health dimensions, but, like most PRO instruments, no single PROMIS instrument captured them all. Clinicians and researchers must consider their goals when selecting PRO instruments, which may require implementing multiple instruments and those beyond PROMIS.

scholarly journals Patient-Reported Outcome Measures in Pancreatic Cancer Receiving Radiotherapy

Cancers ◽  
2020 ◽  
Vol 12 (9) ◽  
pp. 2487
Author(s):  
Ramez Kouzy ◽  
Joseph Abi Jaoude ◽  
Daniel Lin ◽  
Nicholas D. Nguyen ◽  
Molly B. El Alam ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Patient Reported Outcomes ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
European Organization ◽  
Patient Reported ◽  
Pro Tools ◽  
Pro Instruments ◽  
Selection Of

Pancreatic cancer and its treatment often dramatically impact patients’ quality of life (QoL). Given this, as well as increased focus on QoL measures in clinical oncology, there has been a rise in the number of instruments that measure patient-reported outcomes (PROs). In this review, we describe the landscape of different PRO instruments pertaining to pancreatic cancer, with specific emphasis on PRO findings related to pancreatic cancer patients receiving radiotherapy (RT). Twenty-five of the most commonly utilized PROs are compared in detail. Notably, most of the PRO tools discussed are not specific to pancreatic cancer but are generic and have been used in various malignancies. Published findings concerning PROs in pancreatic cancer involving RT are also extracted and summarized. Among the measures used, the European Organization for Research and Treatment Cancer QLQ-C30 was the most commonly utilized. We recommend a careful selection of PRO measures in clinical pancreatic cancer research and care and encourage the use of a combination of symptom-specific and global QoL tools to more fully capture patients’ perspectives.

scholarly journals Functional Performance Testing and Patient Reported Outcomes following ACL Reconstruction: A Systematic Scoping Review

2014 ◽  
Vol 2014 ◽  
pp. 1-14 ◽  
Author(s):  
Adel Almangoush ◽  
Lee Herrington
Keyword(s):  
Acl Reconstruction ◽  
Scoping Review ◽  
Full Text ◽  
Patient Reported Outcomes ◽  
Functional Performance ◽  
Performance Testing ◽  
Cochrane Library ◽  
Performance Tests ◽  
Patient Reported

Objective. A systematic scoping review of the literature to identify functional performance tests and patient reported outcomes for patients who undergo anterior cruciate ligament (ACL) reconstruction and rehabilitation that are used in clinical practice and research during the last decade. Methods. A literature search was conducted. Electronic databases used included Medline, PubMed, Cochrane Library, EMBASE, CINAHL, SPORTDiscus, PEDro, and AMED. The inclusion criteria were English language, publication between April 2004 and April 2014, and primary ACL reconstruction with objective and/or subjective outcomes used. Two authors screened the selected papers for title, abstract, and full-text in accordance with predefined inclusion and exclusion criteria. The methodological quality of all papers was assessed by a checklist of the Critical Appraisal Skills Programme (CASP). Results. A total of 16 papers were included with full-text. Different authors used different study designs for functional performance testing which led to different outcomes that could not be compared. All papers used a measurement for quantity of functional performance except one study which used both quantity and quality outcomes. Several functional performance tests and patient reported outcomes were identified in this review. Conclusion. No extensive research has been carried out over the past 10 years to measure the quality of functional performance testing and control stability of patients following ACL reconstruction. However this study found that the measurement of functional performance following ACL reconstruction consisting of a one-leg hop for a set distance or a combination of different hops using limb symmetry index (LSI) was a main outcome parameter of several studies. A more extensive series of tests is suggested to measure both the quantitative and qualitative aspects of functional performance after the ACL reconstruction. The KOOS and the IKDC questionnaires are both measures that are increasingly being used for ACL reconstruction throughout the last decade.

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