scholarly journals Goal Attainment Scaling as an Outcome Measure for Randomised Controlled Trials: A Systematic Scoping Review

2021 ◽  
Author(s):  
Benignus Logan ◽  
Dev K Jegatheesan ◽  
Andrea K Viecelli ◽  
Elaine Pascoe ◽  
Ruth E Hubbard
Keyword(s):  
Scoping Review ◽  
Randomised Controlled Trials ◽  
Goal Attainment ◽  
Outcome Measure ◽  
Geriatric Medicine ◽  
Goal Attainment Scaling ◽  
Controlled Trials ◽  
Healthcare Settings ◽  
Wide Range ◽  
Randomised Controlled

Abstract BACKGROUND: Goal Attainment Scaling (GAS) is an individualised outcome measure which can be used in research settings to assess achievement of participant-important priorities and goals. METHODS: A systematic scoping review was completed with the objective of: (1) Identifying the healthcare settings in which GAS has been used as an outcome measure. (2) Describing how GAS has been implemented by researchers in those trials. PubMed, CENTRAL, EMBASE and PsycINFO were searched without limits from their inceptions to 1 September 2021 for randomised controlled trials conducted in healthcare settings where GAS was used as an outcome measure for adults. Two reviewers independently completed both the screening and data extraction, with a third adjudicating conflicts. RESULTS: Of 1,764 articles screened, 37 studies were included. Most trials (86%) were solely undertaken in outpatient settings. They were frequently conducted within the disciplines of rehabilitation (57%), geriatric medicine (24%) and neurology (11%). Sample sizes ranged from 8 to 468, with a mean of 84 participants. GAS was a primary outcome measure in 38% of studies. There were inconsistencies between trials in the use of scales and the calculation of GAS scores. Implementation aspects such as the personnel involved, the training provided, and calibration and review mechanisms, were heterogeneously and scarcely reported. CONCLUSIONS: GAS has been used as an outcome measure across a wide range of disciplines and trial settings. However, there are inconsistencies in how it has been applied and implemented. Developing a cross-disciplinary practical guide to support a degree of standardisation in its implementation may be beneficial in increasing the reliability and comparability of trial results.

scholarly journals Rationalisations for women-only randomised controlled trials in conditions that affect both sexes: a scoping review protocol

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e043370
Author(s):  
Ainsley Matthewson ◽  
Olena Bereznyakova ◽  
Brian Dewar ◽  
Alexandra Davis ◽  
Mark Fedyk ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Scoping Review ◽  
Randomised Controlled Trials ◽  
Standard Of Care ◽  
Standards Of Care ◽  
Controlled Trials ◽  
Theory Approach ◽  
Reference Centre ◽  
Cochrane Database ◽  
Randomised Controlled

IntroductionWomen have historically been under-represented in randomised controlled trials (RCTs), including many landmark RCTs that established standards of care. In light of this fact, some modern researchers are calling for replication of earlier landmark trials with women only. This approach is ethically concerning, in that it would require some enrolled women to be deprived of treatments that are currently considered standard of care.ObjectiveIn an attempt to better understand the justification of a women-only approach to designing clinical trials, this study looks to systematically categorise the number of women-only RCTs for conditions that affect both men and women and the reasons given within the medical and philosophical literatures to perform them.MethodologyThis scoping review of the literature will search, screen and select articles based on predetermined inclusion/exclusion criteria, after which a grounded theory approach will be used to synthesise the data. It is expected that there will be a variety of reasons given for why a women-only trial may be justified. Electronic databases that will be searched include MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, Cochrane Clinical Trials Register, Web of Science Proceedings, ClinicalTrials.gov, Philosopher’s Index, Phil Papers, JSTOR, Periodicals Archive Online, Project MUSE and the National Reference Centre for Bioethics.SignificanceThe scope of this study is to determine published rationales used to justify women-only randomised trials, both in the case of new trials and in the repetition of landmark trials.Ethics and disseminationResearch ethics board approval is not required for this study as there is no participant involvement. Results will be published as a stand-alone manuscript and will inform a larger project related to the ethics of a women-only RCT of carotid intervention for women with symptomatic high-grade carotid stenosis.

scholarly journals Effects of self-management education programmes on self-efficacy for osteoarthritis of the knee: a systematic review of randomised controlled trials

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Daisuke Uritani ◽  
Hitoshi Koda ◽  
Sho Sugita
Keyword(s):  
Health Professionals ◽  
Self Efficacy ◽  
Randomised Controlled Trials ◽  
Management Education ◽  
Self Management ◽  
Controlled Trials ◽  
Face To Face ◽  
Knee Oa ◽  
Wide Range ◽  
Randomised Controlled

Abstract Background Enhancing self-efficacy to manage symptoms and functions is an important aspect of self-management for patients with knee osteoarthritis (OA). Many reports have investigated the effects of self-management education programmes for arthritis patients. However, a study that exclusively focuses on patients with OA in the same joints is required to clarify the effects of self-management programmes because individuals with knee OA experience physical and psychological difficulties different from those experienced by individuals with other arthritis diseases. Furthermore, previous studies have reported a wide range of delivery styles of self-management education programmes. This systematic review aimed to evaluate the effects of group-based and face-to-face self-management education programmes conducted by health professionals targeting self-efficacy for knee OA exclusively. Methods The MEDLINE, CENTRAL, EMBASE, CINAHL, Web of Science, and PEDro databases were searched to identify quantitative measures used in randomised controlled trials (RCTs) to assess the effects of self-management education programmes targeting self-efficacy in patients with knee OA. We included studies in which medical professional-delivered self-management education programmes were conducted in a group-based and face-to-face manner in community or outpatient settings. Results Seven RCTs from five countries were included in this review. Our retrieved studies included various types of self-management education programmes such as cognitive behavioural counselling, pain management education, physical education, weight management education, and arthritis self-efficacy management education, and control arms. They assessed various aspects of self-efficacy, including pain, physical function, arthritis symptoms excluding pain, weight management, mobility, and self-regulation. The total score of the Arthritis Self-Efficacy Scale was also measured. Some studies have reported beneficial effects of group-based and face-to-face self-management education programmes on self-efficacy for management of pain and other symptoms and for self-regulatory, knee OA. However, the results of the included studies were varied and inconsistent. Conclusions The current review only included seven studies, and there was a wide range of clinical heterogeneity among these studies. Thus, the effects of group-based and face-to-face self-management education programmes conducted by health professionals on self-efficacy for knee OA exclusively are inconclusive to date. Therefore, high-quality studies are required to provide significant information on clinicians, patients, and healthcare professionals in the future.

scholarly journals Statistical methods for the analysis of adverse event data in randomised controlled trials: a scoping review and taxonomy

2020 ◽  
Author(s):  
Rachel Phillips ◽  
Odile Sauzet ◽  
Victoria Cornelius
Keyword(s):  
Statistical Methods ◽  
Scoping Review ◽  
Randomised Controlled Trials ◽  
Effective Means ◽  
Estimation Methods ◽  
Controlled Trials ◽  
Event Data ◽  
Group Sequential ◽  
Group Sequential Methods ◽  
Randomised Controlled

Abstract BackgroundStatistical methods for the analysis of harm outcomes in randomised controlled trials (RCTs) are rarely used, and there is a reliance on simple approaches to display information such as in frequency tables. We aimed to identify whether any statistical methods had been specifically developed to analyse prespecified secondary harm outcomes and non-specific emerging adverse events (AEs).MethodsA scoping review was undertaken to identify articles that proposed original methods or the original application of existing methods for the analysis of AEs that aimed to detect potential adverse drug reactions (ADRs) in phase II-IV parallel controlled group trials. Methods where harm outcomes were the (co)-primary outcome were excluded.Information was extracted on methodological characteristics such as: whether the method required the event to be prespecified or could be used to screen emerging events; and whether it was applied to individual events or the overall AE profile. Each statistical method was appraised and a taxonomy was developed for classification.ResultsForty-four eligible articles proposing 73 individual methods were included. A taxonomy was developed and articles were categorised as: visual summary methods (8 articles proposing 20 methods); hypothesis testing methods (11 articles proposing 16 methods); estimation methods (15 articles proposing 24 methods); or methods that provide decision-making probabilities (10 articles proposing 13 methods). Methods were further classified according to whether they required a prespecified event (9 articles proposing 12 methods), or could be applied to emerging events (35 articles proposing 61 methods); and if they were (group) sequential methods (10 articles proposing 12 methods) or methods to perform final/one analyses (34 articles proposing 61 methods). ConclusionsThis review highlighted that a broad range of methods exist for AE analysis. Immediate implementation of some of these could lead to improved inference for AE data in RCTs. For example, a well-designed graphic can be an effective means to communicate complex AE data and methods appropriate for counts, time-to-event data and that avoid dichotomising continuous outcomes can improve efficiencies in analysis. Previous research has shown that adoption of such methods in the scientific press is limited and that strategies to support change are needed.

scholarly journals Defining key design elements of registry-based randomised controlled trials: a scoping review

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Bill Karanatsios ◽  
Khic-Houy Prang ◽  
Ebony Verbunt ◽  
Justin M. Yeung ◽  
Margaret Kelaher ◽  
...  
Keyword(s):  
Scoping Review ◽  
Randomised Controlled Trials ◽  
Controlled Trials ◽  
Design Elements ◽  
Randomised Controlled

scholarly journals Protocol for a scoping review of post-trial extensions of randomised controlled trials using individually linked administrative and registry data

BMJ Open ◽  
2017 ◽  
Vol 7 (2) ◽  
pp. e013770 ◽  
Author(s):  
Tiffany Fitzpatrick ◽  
Laure Perrier ◽  
Andrea C Tricco ◽  
Sharon E Straus ◽  
Peter Jüni ◽  
...  
Keyword(s):  
Scoping Review ◽  
Randomised Controlled Trials ◽  
Registry Data ◽  
Controlled Trials ◽  
Post Trial ◽  
Randomised Controlled

scholarly journals Hibiscus Tea and Health: A Scoping Review of Scientific Evidence

2020 ◽  
Vol 6 (1) ◽  
Author(s):  
Etheridge CJ ◽  
Derbyshire EJ
Keyword(s):  
Oxidative Stress ◽  
Risk Factors ◽  
Systematic Review ◽  
Scoping Review ◽  
Randomised Controlled Trials ◽  
Scientific Evidence ◽  
Controlled Trials ◽  
Hibiscus Sabdariffa ◽  
Pubmed Search ◽  
Randomised Controlled

Over the last few decades, health evidence has been building for hibiscus tea (Hibiscus sabdariffa L. Malvaceae). Previous reviews show promise in relation to reducing cardiovascular risk factors, hypertension and hyperlipidaemia, but broader health perspectives have not been widely considered. Therefore, a scoping review was undertaken to examine the overall health effects of hibiscus tea. A PubMed search was undertaken for metaanalysis (MA) and systematic review papers, human randomised controlled trials (RCT) and laboratory publications investigating inter-relationships between hibiscus tea and health. Twenty-two publications were identified (four systematic/MA papers, nine human RCT controlled trials and nine laboratory publications).Strongest evidence exists in relation to cardiovascular disease, suggesting that drinking 2-3 cups daily (each ≈ 240-250 mL) may improve blood pressure and potentially serve as a preventative or adjunctive therapy against such conditions. Emerging evidence exists for favourable effects on lipid profiles, insulin resistance, oxidative stress and inflammation. Further research using larger and longer human studies is warranted.

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