Patient-reported outcomes in head and neck and thyroid cancer randomised controlled trials: A systematic review of completeness of reporting and impact on interpretation

2016 ◽  
Vol 56 ◽  
pp. 144-161 ◽  
Author(s):  
Rebecca L. Mercieca-Bebber ◽  
Alessandro Perreca ◽  
Madeleine King ◽  
Andrew Macann ◽  
Katie Whale ◽  
...  
Keyword(s):  
Systematic Review ◽  
Thyroid Cancer ◽  
Head And Neck ◽  
Randomised Controlled Trials ◽  
Patient Reported Outcomes ◽  
Controlled Trials ◽  
Patient Reported ◽  
Randomised Controlled ◽  
Completeness Of Reporting

scholarly journals Inclusion of older patients with cancer in randomised controlled trials with patient-reported outcomes: a systematic review

2019 ◽  
pp. bmjspcare-2019-001902
Author(s):  
Francesco Sparano ◽  
Neil K Aaronson ◽  
Mirjam A G Sprangers ◽  
Peter Fayers ◽  
Andrea Pusic ◽  
...  
Keyword(s):  
Systematic Review ◽  
Older Patients ◽  
Randomised Controlled Trials ◽  
Patient Reported Outcomes ◽  
Controlled Trials ◽  
High Quality ◽  
Quality Of Life Research ◽  
Patient Reported ◽  
Randomised Controlled

ObjectivesInclusion of patient-reported outcomes (PROs) in cancer randomised controlled trials (RCTs) may be particularly important for older patients. The objectives of this systematic review were to quantify the frequency with which older patients are included in RCTs with PROs and to evaluate the quality of PRO reporting in those trials.MethodsAll RCTs with PRO endpoints, published between January 2004 and February 2019, which included a patient sample with a mean/median age ≥70 years, were considered for this systematic review. The following cancer malignancies were considered: breast, colorectal, lung, prostate, gynaecological and bladder cancer.Quality of PRO reporting was evaluated using the International Society for Quality of Life Research–PRO standards. Studies meeting at least two-thirds of these criteria were considered to have high-quality PRO reporting.ResultsOf 649 RCTs identified with a PRO endpoint, only 72 (11.1%) included older patients. Of these, 35 trials (48.6%) were conducted in patients with metastatic/advanced disease. PROs were primary endpoints in 20 RCTs (27.8%). Overall survival was the most frequently reported clinical outcome in studies of patients with metastatic/advanced cancer (n=28, 80%). One-third of the RCTs (n=24, 33.3%) were considered to have high-quality PRO reporting. Overall, the largest prevalence of RCTs with high-quality PRO reporting was observed in prostate and colorectal cancers.ConclusionsOur review indicates not only that PRO–RCT-based studies in oncology rarely include older patients but also that completeness of PRO reporting of many of them is often suboptimal.

scholarly journals Patient-reported outcomes (PROs) in randomised controlled trials in diabetes and pregnancy: protocol for a systematic review

BMJ Open ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. e052506
Author(s):  
Christine Newman ◽  
Oratile Kgosidialwa ◽  
Louise Dervan ◽  
Delia Bogdanet ◽  
Aoife Maria Egan ◽  
...  
Keyword(s):  
Systematic Review ◽  
Systematic Reviews ◽  
Randomised Controlled Trials ◽  
Patient Reported Outcomes ◽  
Secondary Outcome ◽  
Controlled Trials ◽  
Medical Subject Headings ◽  
Metabolic Complication ◽  
Patient Reported ◽  
Randomised Controlled

IntroductionDiabetes mellitus is the most common metabolic complication of pregnancy and its prevalence worldwide is rising. The number of randomised controlled trials (RCTs) being conducted in people with diabetes is also increasing. Many studies preferentially publish findings on clinical endpoints and do not report patient-reported outcomes (PROs). In studies that do include PROs, PRO reporting is often of poor quality.MethodsWe will conduct this systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Using a combination of medical subject headings and keywords (combined using Boolean operators), we will search web-based databases (PubMed, Cochrane and EMBASE) for RCTs published in English between 2013 and 2021. Two reviewers will review titles and abstracts. We will review the full texts of any relevant abstracts and extract the following data: date of publication or recruitment period, journal of publication, country of study, multicentre or single centre, population and number of participants, type of intervention, frequency of PRO assessment and type of PRO (or PRO measurement) used. We will also record if the PRO was a primary, secondary or exploratory outcome. We will exclude reviews, observational studies, unpublished data for example, conference abstracts and trial protocols. Any published RCT that includes data on a PRO as a primary or secondary outcome will then be compared against the Consolidated Standards of Reporting Trials—Patient-Reported Outcome extension checklist, a structured and approved framework for the publication of results of PROs.Ethics and disseminationEthical approval to conduct this study was obtained from the ethics committee at Galway University Hospitals on 24 March 2021 (CA 2592). We aim to publish our findings in a peer-reviewed journal and present our findings at national and international conferences.Systematic review registrationThis systematic review was registered prospectively with the International Prospective Register of Systematic Reviews (PROSPERO). Registration number CRD42021234917.

scholarly journals Correction to: Sample size estimation for randomised controlled trials with repeated assessment of patient-reported outcomes: what correlation between baseline and follow-up outcomes should we assume?

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Stephen J. Walters ◽  
Richard M. Jacques ◽  
Inês Bonacho dos Anjos Henriques-Cadby ◽  
Jane Candlish ◽  
Nikki Totton ◽  
...  
Keyword(s):  
Sample Size ◽  
Randomised Controlled Trials ◽  
Patient Reported Outcomes ◽  
Sample Size Estimation ◽  
Controlled Trials ◽  
Size Estimation ◽  
Patient Reported ◽  
Randomised Controlled ◽  
Repeated Assessment

Following publication of the original article [1], we have been notified that one of an error in the Conclusions section of the Abstract.

scholarly journals The level of patient-reported outcome reporting in randomised controlled trials of brain tumour patients: A systematic review

2014 ◽  
Vol 50 (14) ◽  
pp. 2432-2448 ◽  
Author(s):  
Linda Dirven ◽  
Martin J.B. Taphoorn ◽  
Jaap C. Reijneveld ◽  
Jane Blazeby ◽  
Marc Jacobs ◽  
...  
Keyword(s):  
Systematic Review ◽  
Brain Tumour ◽  
Randomised Controlled Trials ◽  
Patient Reported Outcome ◽  
Controlled Trials ◽  
Outcome Reporting ◽  
Patient Reported ◽  
Randomised Controlled

scholarly journals Completeness of reporting of randomised controlled trials including people with transient ischaemic attack or stroke: A systematic review

2018 ◽  
Vol 3 (4) ◽  
pp. 337-346 ◽  
Author(s):  
Blair Wilson ◽  
Peter Burnett ◽  
David Moher ◽  
Douglas G Altman ◽  
Rustam Al-Shahi Salman
Keyword(s):  
Systematic Review ◽  
Randomised Controlled Trial ◽  
Randomised Controlled Trials ◽  
Controlled Trial ◽  
Reporting Guidelines ◽  
Controlled Trials ◽  
Ischaemic Attack ◽  
Randomised Controlled ◽  
Over Time ◽  
Completeness Of Reporting

Purpose To assess the adherence of stroke randomised controlled trials to Consolidated Standards Of Reporting Trials reporting guidelines and investigate the factors that are associated with completeness of reporting. Method We took a random sample from the Cochrane Stroke Group's Trial Register of transient ischaemic attack or stroke randomised controlled trials, published in English in 1997–2016 inclusive. Two reviewers assessed the published report of the final primary results of stroke randomised controlled trials with a 10-point truncated Consolidated Standards Of Reporting Trials reporting checklist to investigate adherence over time, univariable associations and independent associations with total Consolidated Standards Of Reporting Trials reporting score in a multiple linear regression model. Findings In this random sample of 177 stroke randomised controlled trials, the mean score on the truncated Consolidated Standards Of Reporting Trials checklist was 5.8 (SD 2.2); reporting improved from 1997–2000 (4.9 SD 2.0) to 2001–2009 (5.8 SD 2.1) and to 2010–2016 (6.8 SD 2.1). A higher Consolidated Standards Of Reporting Trials score was independently associated with publication during epochs following a revision of Consolidated Standards Of Reporting Trials reporting guidelines (p < 0.001), journal endorsement of the Consolidated Standards Of Reporting Trials reporting guideline at the time of randomised controlled trial publication (p < 0.001) and modified journal impact factor using median citation distribution (p = 0.012). Discussion Stroke randomised controlled trial reporting to Consolidated Standards Of Reporting Trials standards has improved over time, but could be better. Conclusion Journal endorsement and enforcement of Consolidated Standards Of Reporting Trials reporting guidelines could further improve the reporting of stroke randomised controlled trials. Systematic review registration: Registered with PROSPERO (CRD42017072193).

scholarly journals Reporting quality of surgical randomised controlled trials in head and neck cancer: a systematic review

2021 ◽  
Author(s):  
Netanya Aarabi Canagarajah ◽  
George James Porter ◽  
Kurchi Mitra ◽  
Timothy Shun Man Chu
Keyword(s):  
Systematic Review ◽  
Head And Neck Cancer ◽  
Head And Neck ◽  
Neck Cancer ◽  
Randomised Controlled Trials ◽  
Reporting Quality ◽  
Controlled Trials ◽  
Randomised Controlled ◽  
Full Design

Abstract Purpose Randomised controlled trials (RCTs) are considered the gold standard for evaluating the efficacy of an intervention. However, previous research has shown that RCTs in several surgical specialities are poorly reported, making it difficult to ascertain if various biases have been appropriately minimised. This systematic review assesses the reporting quality of surgical head and neck cancer RCTs. Methods A literature search of PubMed and Embase was performed. Papers were included if they reported RCTs which assessed a surgical technique used to treat or diagnose head and neck cancer published during or after 2011. The CONSORT 2010 checklist was used to evaluate the reporting quality of these trials. Results 41 papers were included. The mean CONSORT score was 16.5/25 (66% adherence) and the scores ranged from 7.5 (30%) to 25. The most common omissions were full trial protocol (found in 14.6%), participant recruitment method (22%) and effect size with a precision estimate for all outcome measures (29.3%). The full design and implementation of the randomisation methods were reported in 6 (14.6%). Papers published in journals which endorsed CONSORT had significantly higher scores (p = 0.02) and the journal impact factor was significantly correlated with CONSORT score (p = 0.01). Conclusion We have identified several pieces of information that are underreported in surgical head and neck cancer RCTs. These omissions make understanding and comparing the methodologies and conclusions of RCTs more difficult. The endorsement of CONSORT by journals improved adherence, suggesting that wider adoption of the checklist may improve reporting.

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