scholarly journals Incorporating patient reported outcomes (PROs) in gastro-intestinal (GI) cancer randomised controlled trials (RCTs): the need for adequate rationale and integrated reporting

Trials ◽  
2011 ◽  
Vol 12 (S1) ◽  
Author(s):  
Rhiannon C Macefield ◽  
Angus GK McNair ◽  
Natalie S Blencowe ◽  
Sara T Brookes ◽  
Jane M Blazeby
Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Stephen J. Walters ◽  
Richard M. Jacques ◽  
Inês Bonacho dos Anjos Henriques-Cadby ◽  
Jane Candlish ◽  
Nikki Totton ◽  
...  

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


2019 ◽  
pp. bmjspcare-2019-001902
Author(s):  
Francesco Sparano ◽  
Neil K Aaronson ◽  
Mirjam A G Sprangers ◽  
Peter Fayers ◽  
Andrea Pusic ◽  
...  

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.


BMJ Open ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. e052506
Author(s):  
Christine Newman ◽  
Oratile Kgosidialwa ◽  
Louise Dervan ◽  
Delia Bogdanet ◽  
Aoife Maria Egan ◽  
...  

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.


2019 ◽  
Vol 7 (40) ◽  
pp. 1-178 ◽  
Author(s):  
Michael Nunns ◽  
Liz Shaw ◽  
Simon Briscoe ◽  
Jo Thompson Coon ◽  
Anthony Hemsley ◽  
...  

Background Elective older adult inpatient admissions are increasingly common. Older adults are at an elevated risk of adverse events in hospital, potentially increasing with lengthier hospital stay. Hospital-led organisational strategies may optimise hospital stay for elective older adult inpatients. Objectives To evaluate the effectiveness and cost-effectiveness of hospital-led multicomponent interventions to reduce hospital stay for older adults undergoing elective hospital admissions. Data sources Seven bibliographic databases (MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, EMBASE, Health Management Information Consortium, Cochrane Central Register of Controlled Trials, Cumulative Index to Nursing and Allied Health Literature and Allied and Complementary Medicine Database) were searched from inception to date of search (August 2017), alongside carrying out of web searches, citation searching, inspecting relevant reviews, consulting stakeholders and contacting authors. This search was duplicated, with an additional cost-filter, to identify cost-effectiveness evidence. Review methods Comparative studies were sought that evaluated the effectiveness or cost-effectiveness of relevant interventions in elective inpatients with a mean or median age of ≥ 60 years. Study selection, data extraction and quality assessment were completed independently by two reviewers. The main outcome was length of stay, but all outcomes were considered. Studies were sorted by procedure, intervention and outcome categories. Where possible, standardised mean differences or odds ratios were calculated. Meta-analysis was performed when multiple randomised controlled trials had the same intervention, treatment procedure, comparator and outcome. Findings were explored using narrative synthesis. Findings A total of 218 articles were included, with 80 articles from 73 effectiveness studies (n = 26,365 patients) prioritised for synthesis, including 34 randomised controlled trials conducted outside the UK and 39 studies from the UK, of which 12 were randomised controlled trials. Fifteen studies included cost-effectiveness data. The evidence was dominated by enhanced recovery protocols and prehabilitation, implemented to improve recovery from either colorectal surgery or lower limb arthroplasty. Six other surgical categories and four other intervention types were identified. Meta-analysis found that enhanced recovery protocols were associated with 1.5 days’ reduction in hospital stay among patients undergoing colorectal surgery (Cohen’s d = –0.51, 95% confidence interval –0.78 to –0.24; p < 0.001) and with 5 days’ reduction among those undergoing upper abdominal surgery (Cohen’s d = –1.04, 95% confidence interval –1.55 to –0.53; p < 0.001). Evidence from the UK was not pooled (owing to mixed study designs), but it echoed findings from the international literature. Length of stay usually was reduced with intervention or was no different. Other clinical outcomes also improved or were no worse with intervention. Patient-reported outcomes were not frequently reported. Cost and cost-effectiveness evidence came from 15 highly heterogeneous studies and was less conclusive. Limitations Studies were usually of moderate or weak quality. Some intervention or treatment types were under-reported or absent. The reporting of variance data often precluded secondary analysis. Conclusions Enhanced recovery and prehabilitation interventions were associated with reduced hospital stay without detriment to other clinical outcomes, particularly for patients undergoing colorectal surgery, lower limb arthroplasty or upper abdominal surgery. The impacts on patient-reported outcomes, health-care costs or additional service use are not well known. Future work Further studies evaluating of the effectiveness of new enhanced recovery pathways are not required in colorectal surgery or lower limb arthroplasty. However, the applicability of these pathways to other procedures is uncertain. Future studies should evaluate the implementation of interventions to reduce service variation, in-hospital patient-reported outcomes, impacts on health and social care service use, and longer-term patient-reported outcomes. Study registration This study is registered as PROSPERO CRD42017080637. Funding The National Institute for Health Research Health Services and Delivery Research programme.


BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e051673
Author(s):  
Yirui Qian ◽  
Stephen J Walters ◽  
Richard Jacques ◽  
Laura Flight

ObjectivesTo identify how frequently patient-reported outcomes (PROs) are used as primary and/or secondary outcomes in randomised controlled trials (RCTs) and to summarise what statistical methods are used for the analysis of PROs.DesignComprehensive review.SettingRCTs funded and published by the United Kingdom’s (UK) National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme.Data sources and eligibilityHTA reports of RCTs published between January 1997 and December 2020 were reviewed.Data extractionInformation relating to PRO use and analysis methods was extracted.Primary and secondary outcome measuresThe frequency of using PROs as primary and/or secondary outcomes; statistical methods that were used for the analysis of PROs as primary outcomes.ResultsIn this review, 37.6% (114/303) of trials used PROs as primary outcomes, and 82.8% (251/303) of trials used PROs as secondary outcomes from 303 NIHR HTA reports of RCTs. In the 114 RCTs where the PRO was the primary outcome, the most used PRO was the Short-Form 36 (8/114); the most popular methods for multivariable analysis were linear mixed model (45/114), linear regression (29/114) and analysis of covariance (13/114); logistic regression was applied for binary and ordinal outcomes in 14/114 trials; and the repeated measures analysis was used in 39/114 trials.ConclusionThe majority of trials used PROs as primary and/or secondary outcomes. Conventional methods such as linear regression are widely used, despite the potential violation of their assumptions. In recent years, there is an increasing trend of using complex models (eg, with mixed effects). Statistical methods developed to address these violations when analysing PROs, such as beta-binomial regression, are not routinely used in practice. Future research will focus on evaluating available statistical methods for the analysis of PROs.


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