Does the quality of patient-reported outcomes (PROs) assessment in randomized controlled trials (RCTs) differ across cancer types and over time? A pooled analysis of 610 RCTs published between 2004 and 2018.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e18218-e18218
Author(s):  
Francesco Sparano ◽  
Neil K Aaronson ◽  
Mirjam A.G. Sprangers ◽  
Peter Fayers ◽  
Andrea Pusic ◽  
...  
Keyword(s):  
Pooled Analysis ◽  
Site Quality ◽  
Cancer Site ◽  
Cancer Type ◽  
Quality Of Reporting ◽  
Quality Of Life Research ◽  
Patient Reported ◽  
Consort Pro ◽  
Over Time

e18218 Background: PRO endpoints are increasingly being used in cancer RCTs. However, the PRO assessment in such trials often suffers from serious methodological shortcomings, and the results seldom impact on clinical policy or practice. Methods: We performed a systematic review to identify RCTs with a PRO endpoint in breast, colorectal, lung, prostate, gynaecological and bladder cancer. A checklist score for quality of PRO reporting (ranging between 0-100), based on that of the International Society for Quality of Life Research (ISOQOL) and the CONSORT PRO extension, was computed for each RCT. Analyses were also conducted by type of PRO endpoint (primary versus secondary) and year of publication (i.e. before and after the publication of the CONSORT PRO extension). Results: We identified 610 RCTs with a total of 323,482 patients. PROs were most frequently used in RCTs of breast (N = 176), followed by lung (N = 123), prostate (N = 108), colorectal (N = 103), gynaecological (N = 83) and bladder (N = 17) cancer. Quality of PRO reporting (mean score: 56.4) was highest in RCTs conducted in prostate cancer (PCa) (Table). Regardless of cancer type, quality of reporting was typically higher in RCTs where PROs were primary endpoints. Quality of reporting was higher for RCTs published after the CONSORT PRO Extension (2013), with the exception of RCTs conducted in PCa, where quality was stable over time. Conclusions: PRO reporting of RCTs conducted in PCa has better quality than in the other cancer sites that were reviewed. Regardless of cancer site, quality of PRO reporting has improved after the publication of the CONSORT PRO Extension. [Table: see text]

Health-related quality of life (HRQOL) in non-small cell lung cancer (NSCLC): An update of a systematic review on methodological issues in randomized controlled trials (RCTs)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 9604-9604
Author(s):  
L. Claassens ◽  
J. van Meerbeeck ◽  
C. Coens ◽  
C. Quinten ◽  
X. S. Wang ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Decision Making ◽  
Clinical Decision ◽  
Clinical Findings ◽  
Cancer Site ◽  
Quality Of Reporting ◽  
Patient Reported ◽  
Related Quality ◽  
Health Related

9604 Background: NSCLC is a prevalent cancer site and RCTs frequently assess patient HRQOL, given the modest survival gains. This study is an update of a systematic review (JCO, 2003) on the HRQOL methodology in NSCLC RCTs. The objective was gaining insight into the evolution of HRQOL methodology over the last decades to help understand if the quality of reporting—and its benefit for clinical-decision making—has improved. Methods: A systematic literature review was undertaken through Medline. RCTs including newly diagnosed NSCLC patients with age ≥ 18, who underwent chemotherapy and/or radiotherapy; comprising patient-reported HRQOL endpoints; and published in English from 2002 to end 2008 were eligible. Two independent reviewers evaluated demographics, trial design, HRQOL measurements and statistical analysis. Results: Forty-five RCTs including 16,382 patients were selected, versus 29 trials between 1980 and 2002. Overall, the quality of HRQOL methodology reported was adequate, although no improvement over time was noticed. Comparisons to the former review led to similar results (p > .05): Of the 45 RCTs, HRQOL end points were primary objectives in 20%. Significant HRQOL between-treatment differences were found in 60% of the RCTs. Adequacy of result presentation was found for a majority (71%). Few studies paid attention to clinically meaningful differences (36%). The EORTC and FACIT tools and the LCSS were most commonly applied in 56%, 18% and 13% respectively. There was sufficient detailing on domains, time points and patient compliance (> 70%), but little on instrument administration methods (18%). However, HRQOL hypothesis (9%); instrument rationale (11%); verification of the cultural validity (29%); and impact of missing data (31%) were addressed to a significantly less extent than before 2002 (p < .05). Conclusions: The number of RCTs incorporating HRQOL assessments in the NSCLC population has increased considerably. Despite the acceptable quality of the HRQOL methodology reporting, certain aspects remain poorly addressed. Our findings suggest the need for international standardization of HRQOL reporting, similar to the CONSORT guidelines for clinical findings. No significant financial relationships to disclose.

scholarly journals Quality of patient-reported outcome reporting according to the CONSORT statement in randomized controlled trials with glioblastoma patients

2020 ◽  
Author(s):  
Louis Garnier ◽  
Emilie Charton ◽  
Antoine Falcoz ◽  
Sophie Paget-Bailly ◽  
Dewi Vernerey ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Consort Statement ◽  
Quality Score ◽  
Controlled Trials ◽  
Quality Of Reporting ◽  
Factors Associated ◽  
Randomized Controlled ◽  
Patient Reported ◽  
Consort Pro

Abstract Background Randomized controlled trials (RCTs) represent the best evidence in oncology research. Glioblastoma is the most frequent and deadly primary brain tumor, affecting health-related quality of life. An important end point is patient-reported outcomes (PROs). There are no data regarding how well publications of glioblastoma RCTs report PROs. A specific PRO extension of the Consolidated Standards of Reporting Trials (CONSORT) statement was created to improve the quality of reporting. The aim of this study was to evaluate adherence to the CONSORT-PRO statement in reporting RCTs addressing the treatment of patients with glioblastoma. PRO analysis methodology was explored and criteria associated with higher quality of reporting were investigated. Methods From PubMed/MEDLINE and the Cochrane Library databases, all phase 2 and 3 RCTs related to glioblastoma published between 1995 and 2018 were reviewed according to the CONSORT-PRO statements. An overall quality score on a 0 to 100 scale was defined based on these criteria and factors associated with this score were identified. Results Forty-four RCTs were identified as relevant according to predefined criteria. The median overall quality score was 26. No difference was observed regarding reporting quality over the years. CONSORT-PRO items concerning data collection and analysis were poorly reported. Thirty-four trials (77%) used longitudinal data. The most frequent statistical method for PROs analysis was the mean change from baseline (63%). Factors associated with improved overall quality score were the presence of a secondary publication dedicated to PROs results, the statement of any targeted dimensions, and when trials reported results using multiple methods. Conclusion Despite the importance of measuring PROs in patients with glioblastoma, employment of the CONSORT-PRO statement is poor in RCTs.

Biopsychosocial Patterning of Multimorbidity and Its Consequences

2018 ◽  
pp. 220-236
Author(s):  
Elliot Friedman ◽  
Beth LeBreton ◽  
Lindsay Fuzzell ◽  
Elizabeth Wehrpsann
Keyword(s):  
Quality Of Life ◽  
Older Adults ◽  
Functional Outcomes ◽  
The United States ◽  
Chronic Medical Conditions ◽  
Quality Of Life Research ◽  
Increased Risk ◽  
Over Time

By many estimates the majority of adults over age 65 have two or more chronic medical conditions (multimorbidity) and are consequently at increased risk of adverse functional outcomes. Nonetheless, many older adults with multimorbidity are able to maintain high levels of function and retain good quality of life. Research presented here is designed to understand the influences that help ensure better functional outcomes in these older adults. This chapter presents findings that draw on data from the Midlife in the United States study. The independent and interactive contributions of diverse factors to multimorbidity and changes in multimorbidity over time are reviewed. The degree that multimorbidity increases risk of cognitive impairment and disability is examined. The role of inflammation as a mediator is considered. Multimorbidity is increasingly the norm for older adults, so better understanding of factors contributing to variability in multimorbidity-related outcomes can lead to improved quality of life.

scholarly journals Quality of life assessments in clinical practice using either the EORTC-QLQ-C30 or the SEIOQL-DW: a randomized study

2021 ◽  
Vol 5 (1) ◽  
Author(s):  
Åsa Kettis ◽  
Hanna Fagerlind ◽  
Jan-Erik Frödin ◽  
Bengt Glimelius ◽  
Lena Ring
Keyword(s):  
Quality Of Life ◽  
Clinical Practice ◽  
Significant Difference ◽  
Patient Reported ◽  
Health Related Qol ◽  
Health Related ◽  
Secondary Outcomes ◽  
The Impact ◽  
Over Time

Abstract Background Effective patient-physician communication can improve patient understanding, agreement on treatment and adherence. This may, in turn, impact on clinical outcomes and patient quality of life (QoL). One way to improve communication is by using patient-reported outcome measures (PROMs). Heretofore, studies of the impact of using PROMs in clinical practice have mostly evaluated the use of standardized PROMs. However, there is reason to believe that individualized instruments may be more appropriate for this purpose. The aim of this study is to compare the effectiveness of the standardized QoL-instrument, the European Organization for Research and Treatment of Cancer Quality of Life C-30 (EORTC-QOL-C30) and the individualized QoL instrument, the Schedule for the Evaluation of Individual Quality of Life-Direct Weighting (SEIQoL-DW), in clinical practice. Methods In a prospective, open-label, controlled intervention study at two hospital out-patient clinics, 390 patients with gastrointestinal cancer were randomly assigned either to complete the EORTC-QOL-C30 or the SEIQoL-DW immediately before the consultation, with their responses being shared with their physician. This was repeated in 3–5 consultations over a period of 4–6 months. The primary outcome measure was patients’ health-related QoL, as measured by FACIT-G. Patients’ satisfaction with the consultation and survival were secondary outcomes. Results There was no significant difference between the groups with regard to study outcomes. Neither intervention instrument resulted in any significant changes in health-related QoL, or in any of the secondary outcomes, over time. This may reflect either a genuine lack of effect or sub-optimization of the intervention. Since there was no comparison to standard care an effect in terms of lack of deterioration over time cannot be excluded. Conclusions Future studies should focus on the implementation process, including the training of physicians to use the instruments and their motivation for doing so. The effects of situational use of standardized or individualized instruments should also be explored. The effectiveness of the different approaches may depend on contextual factors including physician and patient preferences.

scholarly journals CTNI-01. EFFECT OF STEREOTACTIC RADIOSURGERY COMPARED TO WHOLE-BRAIN RADIOTHERAPY FOR LIMITED BRAIN METASTASIS ON LONG TERM COGNITION AND QUALITY OF LIFE: A POOLED ANALYSIS OF RANDOMIZED CLINICAL TRIALS

2020 ◽  
Vol 22 (Supplement_2) ◽  
pp. ii40-ii41
Author(s):  
Joshua Palmer ◽  
Brett Klamer ◽  
Karla Ballman ◽  
Paul Brown ◽  
Jane Cerhan ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Clinical Trials ◽  
Whole Brain Radiotherapy ◽  
Pooled Analysis ◽  
Cognitive Outcomes ◽  
Phase Iii ◽  
Brain Radiotherapy ◽  
Over Time

Abstract PURPOSE We investigated the long term impact of SRS and WBRT in two large prospective phase III trials. METHODS Patients with 1–4 BMs +/- resection were randomized to SRS or WBRT. Cognitive deterioration was a drop of &gt;1 standard deviation from baseline in &gt;2/6 cognitive measures (CM). Quality of life (QOL) scores were scored 0–100 point scale. CM and QOL scores were modeled using baseline adjusted Linear Mixed Models (LMM) with uncorrelated random intercept for subject and random slopes for time. Differences over time between groups and the effect of &gt;2 cognitive scores with &gt;2 SD change from baseline were assessed. RESULTS 88 patients were included with median follow up of 24 months. We observed decreasing CM over time (SRS: 4/6; WBRT: 5/6). Mean CM was significantly higher in SRS for Total recall and Delayed Recall at 3, 6, 9, 12 months. More patients in WBRT arm declined 1 SD in &gt;1 and &gt;2 CM at the 3, 6, 9, and 12 months. A 1 SD decline in &gt;3 CM at 1 year was 21% SRS vs 47% WBRT (p=0.02). SRS had fewer patients with a 2 SD decline in &gt;1 CM at every time point. SRS had fewer patients with a 2 SD decline at &gt;2 and &gt;3 CM. WBRT had lower QOL at 3 months, but switched to SRS having lower QOL at 24 months for PWB, EWB, FWB, FactG, BR, and FactBR (p&lt; 0.05). A 2 SD decline in cognition decreased mean FWB by 6.4 units (95% CI: -11, -1.75; p=0.007) and decreased QOL by 5.1 units (95% CI: -7.7, -2.5; p&lt; 0.001). CONCLUSIONS We report the first pooled prospective study demonstrating the long term outcomes of patients with BMs after cranial radiation. WBRT was associated with worse cognitive outcomes. Impaired cognition is associated with worse QOL.

275 POSTOPERATIVE COMPLICATIONS DO NOT AFFECT QUALITY OF LIFE AFTER ESOPHAGECTOMY

2020 ◽  
Vol 33 (Supplement_1) ◽  
Author(s):  
E Jezerskyte ◽  
H Laarhoven ◽  
M Sprangers ◽  
W Eshuis ◽  
M Hulshof ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Postoperative Complications ◽  
Term Survival ◽  
Radio Therapy ◽  
Significant Difference ◽  
Patient Reported ◽  
Short And Long Term ◽  
Over Time

Abstract   Despite the attempts to reduce postoperative complication incidence after esophageal cancer surgery, up to 60% of patients endure postoperative complications. These patients often have a reduced health related quality of life (HR-QoL) and it may also have a negative effect on long-term survival. The aim of this study is to investigate the difference in short- and long-term HR-QoL in patients with and without a complicated postoperative course. Methods A retrospective comparative cohort study was performed with data from the Dutch Cancer Registry (IKNL) and QoL questionnaires from POCOP, a longitudinal patient reported outcomes study. All patients with esophageal and gastroesophageal junction (GEJ) cancer after an esophagectomy with or without neoadjuvant chemo(radio) therapy in the period of 2015–2018 were included. Exclusion criteria were palliative surgery, patients with a recurrence, reconstruction with a colonic or jejunal interposition, no reconstruction and emergency surgery. HR-QoL was investigated at baseline and at 3, 6, 9, 12, 18 and 24 months postoperatively between patients with and without complications following an esophagectomy. Results A total of 486 patients were included: 270 with and 216 without postoperative complications. The majority of patients were male (79.8%) with a median age of 66 years (IQR 60–70.25). Significantly more patients had comorbidities in the group with postoperative complications (69.6% vs 57.3%, p = 0.001). A significant difference in HR-QoL over time was found between the two groups in “choked when swallowing” score (p = 0.028). Patients that endured postoperative complications reported more problems with choking when swallowing at 9 months follow-up (mean score 12.9 vs 8.4, p = 0.047). This difference was not clinically relevant with a mean score difference of 4.6 points. Conclusion Postoperative complications do not significantly influence the short- and long-term HR-QoL in patients following an esophagectomy. Only one HR-QoL domain showed difference over time, however, this was not clinically relevant.

A Systematic Literature Review on the Application of Rasch Analysis in Musculoskeletal Disease — A Special Interest Group Report of OMERACT 11

2013 ◽  
Vol 41 (1) ◽  
pp. 159-164 ◽  
Author(s):  
Ying-Ying Leung ◽  
May-Ee Png ◽  
Philip Conaghan ◽  
Alan Tennant
Keyword(s):  
Literature Review ◽  
Outcome Measures ◽  
Interest Group ◽  
Systematic Literature Review ◽  
Rasch Model ◽  
Special Interest ◽  
Rasch Analysis ◽  
Quality Of Reporting ◽  
Over Time

Objective.The Rasch measurement model provides robust analysis of the internal construct validity of outcome measures. We reviewed the application of Rasch analysis in musculoskeletal medicine as part of the work leading to discussion in a Special Interest Group in Rasch Analysis at Outcome Measures in Rheumatology 11.Methods.A systematic literature review of SCOPUS and MEDLINE was performed (January 1, 1985, to February 29, 2012. Original research reports in English using “Rasch” or “Item Response Theory” in musculoskeletal diseases were assessed by 2 independent reviewers. The topics of focus and analysis methodology details were recorded.Results.Of 212 articles reviewed, 114 were included. The number of publications rose from 1 in 1991–1992 to 23 in 2011–February 2012. Disease areas included rheumatoid arthritis (28%), osteoarthritis (16.6%), and general musculoskeletal disorders (43%). Sixty-six reports (57.9%) evaluated psychometric properties of existing scales and 35 (30.7%) involved development of new scales. Nine articles (7.9%) were on methodology illustration. Four articles were on item banking and computer adaptive testing. A majority of the articles reported fit statistics, while the basic Rasch model assumption (i.e., unidimensionality) was examined in only 57.2% of the articles. An improvement in reporting qualities with Rasch articles was noted over time. In addition, only 11.4% of the articles provided a transformation table for interval scale measurement in clinical practice.Conclusion.The Rasch model has been increasingly used in rheumatology over the last 2 decades in a wide range of applications. The majority of the articles demonstrated reasonable quality of reporting. Improvements in quality of reporting over time were revealed.

scholarly journals The Quality of Randomized Controlled Trials in High-impact Rheumatology Journals, 1998–2018

2020 ◽  
Vol 47 (9) ◽  
pp. 1446-1449
Author(s):  
Michael S. Putman ◽  
Ashley Harrison Ragle ◽  
Eric M. Ruderman
Keyword(s):  
Randomized Controlled Trials ◽  
Patient Reported Outcome Measures ◽  
High Impact ◽  
Controlled Trials ◽  
Industry Funding ◽  
Primary Analysis ◽  
Randomized Controlled ◽  
Patient Reported ◽  
Over Time

Objective.Well-designed randomized controlled trials (RCT) mitigate bias and confounding, but previous evaluations of rheumatology trials found high rates of methodological flaws. Outside of rheumatoid arthritis, no studies in the modern era have assessed the quality of rheumatology RCT over time or regarding industry funding.Methods.We identified all RCT published in 3 high-impact rheumatology journals from 1998, 2008, and 2018. Quality metrics derived from a modified Jadad scale were analyzed by year of publication and by funding source.Results.Ninety-six publications met inclusion criteria; 82 of these described the primary analysis of an RCT. Over time (1998–2008–2018), trials were less likely to adequately report dropouts and withdrawals (100% vs 82% vs 60%; p < 0.01) or include an active comparator (44% vs 12% vs 13%; p = 0.01). Later trials were more likely to evaluate biologic therapy (11% vs 38% vs 83%; p < 0.01) and report adequate randomization procedures (39% vs 29% vs 60%; p = 0.04). Seventy-nine percent of trials received industry funding. Industry-funded trials were more likely to report double-blinding (86% vs 53%; p < 0.01), patient-reported outcome measures (77% vs 41%; p < 0.01), and intention-to-treat analyses (86% vs 65%; p = 0.04).Conclusion.Industry-funded trials comprise the majority of RCT published in high-impact rheumatology journals and more frequently report metrics associated with RCT quality. RCT assessing active comparators and nonbiologic therapies have become less common in high-impact rheumatology journals.

Change over time in patient-reported symptoms and quality of life in Edmonton interdisciplinary menopause clinics

2019 ◽  
Vol 26 (9) ◽  
pp. 1031-1037
Author(s):  
Beate C. Sydora ◽  
Nese Yuksel ◽  
Vikas Chadha ◽  
Lori Battochio ◽  
Lori Reich-Smith ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Change Over Time ◽  
Patient Reported ◽  
Over Time
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