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 We will exclude reviews, observational studies, unpublished data for example, conference abstracts and trial protocols.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 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 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 Mindfulness-based interventions for mental well-being among people with multiple sclerosis: a systematic review and meta-analysis of randomised controlled trials

2019 ◽  
Vol 90 (9) ◽  
pp. 1051-1058 ◽  
Author(s):  
Robert Simpson ◽  
Sharon Simpson ◽  
Nitish Ramparsad ◽  
Margaret Lawrence ◽  
Jo Booth ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Systematic Review ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Treatment Options ◽  
Well Being ◽  
Controlled Trials ◽  
Medical Subject Headings ◽  
Randomised Controlled ◽  
Mental Well Being

ObjectiveImpairment of mental well-being (anxiety, depression, stress) is common among people with multiple sclerosis (PwMS). Treatment options are limited, particularly for anxiety. The aim of this study was to update our previous systematic review (2014) and evaluate via meta-analysis the efficacy of mindfulness-based interventions (MBIs) for improving mental well-being in PwMS.MethodsSystematic searches for eligible randomised controlled trials (RCTs) were carried out in seven major databases (November 2017, July 2018), using medical subject headings and key words. Studies were screened, data extracted, quality appraised and analysed by two independent reviewers, using predefined criteria. Study quality was assessed using the Cochrane Collaboration risk of bias tool. Mental well-being was the primary outcome. Random effects model meta-analysis was performed, with effect size reported as standardised mean difference (SMD).ResultsTwelve RCTs including 744 PwMS were eligible for inclusion in the systematic review, eight had data extractable for meta-analysis; n=635. Ethnicity, socioeconomic status, comorbidity and disability were inconsistently reported. MBIs varied from manualised to tailored versions, lasting 6–9 weeks, delivered individually and via groups, both in person and online. Overall SMD for mental well-being (eight studies) was 0.40 (0.28–0.53), p<0.01, I2=28%; against active comparators only (three studies) SMD was 0.17 (0.01–0.32), p<0.05, I2 =0%. Only three adverse events were reported.ConclusionsMBIs are effective at improving mental well-being in PwMS. More research is needed regarding optimal delivery method, cost-effectiveness and comparative-effectiveness.PROSPERO registration numberCRD42018093171.

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 Pharmacotherapeutic Options for Managing Neuropathic Pain: A Systematic Review and Meta-Analysis

2021 ◽  
Vol 2021 ◽  
pp. 1-13
Author(s):  
Giulia Di Stefano ◽  
Andrea Di Lionardo ◽  
Giuseppe Di Pietro ◽  
Giorgio Cruccu ◽  
Andrea Truini
Keyword(s):  
Systematic Review ◽  
Neuropathic Pain ◽  
Systematic Reviews ◽  
Randomised Controlled Trials ◽  
Fatty Acid Amide Hydrolase ◽  
Data Extraction ◽  
Meta Analysis ◽  
Acid Amide ◽  
Controlled Trials ◽  
Randomised Controlled

Despite an increasing number of available therapies, the treatment of neuropathic pain remains a major issue. Systematic reviews and meta-analyses indicate that only a minority of patients with neuropathic pain have an adequate response to pharmacological treatment and that most drugs have dose-limiting side effects. We conducted a systematic review and meta-analysis of randomised controlled trials published in the last five years. We searched for relevant papers within PubMed, EMBASE, the Cochrane Database of Systematic Reviews, and the Clinical Trials database (ClinicalTrials.gov). Two authors independently selected studies for inclusion, data extraction, and bias assessment. We identified 39 randomised controlled trials and included 16 in the meta-analysis. Trial outcomes were generally modest even for first-line drugs such as tricyclic antidepressants, serotonin-noradrenaline reuptake inhibitors, and gabapentinoids. Many drugs acting on new pain targets are currently under development. Clinical data are currently available for sodium channel isoform-specific antagonists, anti-nerve growth factor molecules, and fatty acid amide hydrolase inhibitors.

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