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

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.

Under-Reporting of Patient-Reported Outcome in Hematological Malignancies Trials

Introduction: Patient-reported outcomes (PRO) provide meaningful insight into patient perspectives on treatment effect. Clinically relevant outcomes such as improvements in overall survival (OS) and quality of life (QOL) should guide clinical decision-making, furthermore, the FDA encourages the implementation of patient-centric PRO measures in clinical trials. Objectives: To evaluate the frequency at which PRO measures included in clinical trials, are made publicly available when trial results are published. Methods: We searched Citeline® Trialtrove database, a registry of clinical trials, for randomized phase 2/3 and 3 clinical trials evaluating patients with hematological malignancies, completing enrollment between the years 2007-2017, for which PRO endpoints were listed. We excluded trials evaluating supportive care. We recorded the following data: indication, treatment and comparator, phase, primary endpoint, type of scale or questionnaire used for PRO endpoint. We then identified all available publications associated with the trial, and recorded type of publication (abstract or full text), year, reported outcomes, and 13 criteria of CONSORT-PRO that reflect the completeness of reporting. Results: We identified 362 trials through our search. 53 trials were listed as including at least one PRO endpoint, of which 8 were never published. Indications are listed in Table. PRO endpoints were assessed utilizing 26 PRO different tools, 7 were disease specific, 2 were treatment specific. PRO was the primary outcome in two trials. EORTC-QLQ-30 was most frequently used tool. Study sponsor was industry-only in 21 trials, industry-academic in six, and academic in 18. Of the 45 trials analyzed, only 19 (42%) published any PRO data. Eleven of all trials (24%) were judged as comprehensively reporting PRO. The median number of CONSORT-PRO quality indicators was eight criteria. Of the 45 trials, 12 provided information about missing PRO data. Of the 15 trials that showed PFS benefit with no OS benefit, 8(53%) did not publish any results the PRO, to support a patient centric outcome. 36 of the trials were published as full-text, and nine as abstract. In considering the 36 full text publications, 17 (47%) did not report any PRO. Nine of the full-text publications, reported PRO as part of the primary publication or within the following 6 months. Conclusions: Despite a growing emphasis on QOL and use of PROs in oncology clinical trials, and despite patient and health provider efforts to record PRO data, most hematologic malignancies randomized trials still do not report the PRO endpoints. In several cases they were published later and in a partial manner, minimizing their impact on treatment decisions. This may indicate a disregard to PRO data collected, incomplete collection or methodological flaws in data analysis. Regardless of the reason, PRO data should be routinely included in study publications to allow for a complete assessment of investigational treatment outcome - including disease related outcomes, as well as those reported by the patients themselves. Disclosures No relevant conflicts of interest to declare.

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.

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]

Systematic Evaluation of Patient-Reported Outcome Protocol Content and Reporting in Cancer Trials

Background Patient-reported outcomes (PROs) are captured within cancer trials to help future patients and their clinicians make more informed treatment decisions. However, variability in standards of PRO trial design and reporting threaten the validity of these endpoints for application in clinical practice. Methods We systematically investigated a cohort of randomized controlled cancer trials that included a primary or secondary PRO. For each trial, an evaluation of protocol and reporting quality was undertaken using standard checklists. General patterns of reporting where also explored. Results Protocols (101 sourced, 44.3%) included a mean (SD) of 10 (4) of 33 (range = 2–19) PRO protocol checklist items. Recommended items frequently omitted included the rationale and objectives underpinning PRO collection and approaches to minimize/address missing PRO data. Of 160 trials with published results, 61 (38.1%, 95% confidence interval = 30.6% to 45.7%) failed to include their PRO findings in any publication (mean 6.43-year follow-up); these trials included 49 568 participants. Although two-thirds of included trials published PRO findings, reporting standards were often inadequate according to international guidelines (mean [SD] inclusion of 3 [3] of 14 [range = 0–11]) CONSORT PRO Extension checklist items). More than one-half of trials publishing PRO results in a secondary publication (12 of 22, 54.5%) took 4 or more years to do so following trial closure, with eight (36.4%) taking 5–8 years and one trial publishing after 14 years. Conclusions PRO protocol content is frequently inadequate, and nonreporting of PRO findings is widespread, meaning patient-important information may not be available to benefit patients, clinicians, and regulators. Even where PRO data are published, there is often considerable delay and reporting quality is suboptimal. This study presents key recommendations to enhance the likelihood of successful delivery of PROs in the future.

Systematic Review Comparing Laparoscopic and Open Appendectomy

Various prospective randomized controlled trials were conducted to compare open and laparoscopic appendectomies. The aim of this systematic review is to compare both the surgical appendectomy interventions and to evaluate the most favored, safe, and effective choice of treatment for appendicitis. In this review, 2462 studies have been retrieved from three major databases: Medline, Scopus, and Cochrane. The inclusion criteria were clinical diagnosis of appendicitis, publication date, and patient’s age. Of these, six studies that met both inclusion and exclusion criteria were chosen. The studies selected were assessed for quality using the CONSORT PRO tool. The data extracted was later analyzed using NCCS 2007 software and Microsoft excel. The means and P values were calculated using the student t test and chi square test provided by the studies. The six studies chosen met the inclusion criteria and achieved an average quality of 15.5 over 25, which is in line with the CONSORT PRO tool. The results indicated that further elaboration on the randomization method should’ve been provided; however, the methodology was the same across the six studies showing a strong correlation and homogeneity in the outcomes. The primary outcomes were all favored in laparoscopic appendectomy (LA) except for intra-abdominal abscesses. The secondary outcomes were all favored by LA except for cost and mortality, which weren’t favored by both the interventions. In conclusion, LA is a safer and more effective surgical procedure than open appendectomy.