Integrative Medicine and Prospective Research on CAM

Controlled Trials ◽

Pragmatic Clinical Trials ◽

Alternative Approaches ◽

Research Study Design ◽

Prospective Research ◽

Future Direction ◽

There is a link between integrative medicine (IM) and prospective research on complementary and alternative medicine (CAM). IM is the future direction of CAM and research is needed to support clinical practice. Meaning of IM, proposed models of IM, and existing research on IM will be presented. Prospective research on CAM will cover methodologies presenting randomised controlled trials, harms studies of CAM in kidney disease, and a gap of CAM research. Study design and outcome measures are current challenges in CAM/IM research. Several networks of CAM research worldwide are still working on them and have proposed possible alternative approaches, such as pragmatic clinical trials and cohort multiple randomised controlled trials. These approaches would solve some limitations of randomised controlled trials in CAM research.

Integrative Medicine and Prospective Research on CAM

Complementary and Alternative Medicine ◽

10.4018/978-1-5225-7039-4.ch002 ◽

2019 ◽

pp. 17-37

Author(s):

Mayuree Tangkiatkumjai ◽

Annalisa Casarin

Keyword(s):

Clinical Trials ◽

Integrative Medicine ◽

Controlled Trials ◽

Pragmatic Clinical Trials ◽

Alternative Approaches ◽

Research Study Design ◽

Prospective Research ◽

Future Direction ◽

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

BMJ Open ◽

10.1136/bmjopen-2020-043370 ◽

2021 ◽

Vol 11 (2) ◽

pp. e043370

Author(s):

Ainsley Matthewson ◽

Olena Bereznyakova ◽

Brian Dewar ◽

Alexandra Davis ◽

Mark Fedyk ◽

...

Keyword(s):

Clinical Trials ◽

Scoping Review ◽

Standard Of Care ◽

Standards Of Care ◽

Controlled Trials ◽

Theory Approach ◽

Reference Centre ◽

Cochrane Database ◽

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.

Stability of ARDS subphenotypes over time in two randomised controlled trials

Thorax ◽

10.1136/thoraxjnl-2017-211090 ◽

2018 ◽

Vol 73 (5) ◽

pp. 439-445 ◽

Cited By ~ 37

Author(s):

Kevin Delucchi ◽

Katie R Famous ◽

Lorraine B Ware ◽

Polly E Parsons ◽

B Taylor Thompson ◽

...

Keyword(s):

Clinical Trials ◽

Clinical Outcomes ◽

Latent Class ◽

Lung Protective Ventilation ◽

Controlled Trials ◽

Transition Analysis ◽

Class 1 ◽

Randomised Controlled ◽

Over Time

RationaleTwo distinct acute respiratory distress syndrome (ARDS) subphenotypes have been identified using data obtained at time of enrolment in clinical trials; it remains unknown if these subphenotypes are durable over time.ObjectiveTo determine the stability of ARDS subphenotypes over time.MethodsSecondary analysis of data from two randomised controlled trials in ARDS, the ARMA trial of lung protective ventilation (n=473; patients randomised to low tidal volumes only) and the ALVEOLI trial of low versus high positive end-expiratory pressure (n=549). Latent class analysis (LCA) and latent transition analysis (LTA) were applied to data from day 0 and day 3, independent of clinical outcomes.Measurements and main resultsIn ALVEOLI, LCA indicated strong evidence of two ARDS latent classes at days 0 and 3; in ARMA, evidence of two classes was stronger at day 0 than at day 3. The clinical and biological features of these two classes were similar to those in our prior work and were largely stable over time, though class 2 demonstrated evidence of progressive organ failures by day 3, compared with class 1. In both LCA and LTA models, the majority of patients (>94%) stayed in the same class from day 0 to day 3. Clinical outcomes were statistically significantly worse in class 2 than class 1 and were more strongly associated with day 3 class assignment.ConclusionsARDS subphenotypes are largely stable over the first 3 days of enrolment in two ARDS Network trials, suggesting that subphenotype identification may be feasible in the context of clinical trials.

Interventions for oropharyngeal dysphagia in acute and critical care: a protocol for a systematic review and meta-analysis

Systematic Reviews ◽

10.1186/s13643-019-1196-0 ◽

2019 ◽

Vol 8 (1) ◽

Cited By ~ 4

Author(s):

Sallyanne Duncan ◽

Jennifer Mc Gaughey ◽

Richard Fallis ◽

Daniel F. McAuley ◽

Margaret Walshe ◽

...

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Critical Care ◽

Acute Care ◽

Meta Analysis ◽

Oropharyngeal Dysphagia ◽

Length Of Hospital Stay ◽

Controlled Trials ◽

Abstract Background Oropharyngeal dysphagia or swallowing difficulties are common in acute care and critical care, affecting 47% of hospitalised frail elderly, 50% of acute stroke patients and approximately 62% of critically ill patients who have been intubated and mechanically ventilated for prolonged periods. Complications of dysphagia include aspiration leading to chest infection and pneumonia, malnutrition, increased length of hospital stay and re-admission to hospital. To date, most dysphagia interventions in acute care have been tested with acute stroke populations. While intervention studies in critical care have been emerging since 2015, they are limited and so there is much to learn about the type, the delivery and the intensity of treatments in this setting to inform future clinical trials. The aim of this systematic review is to summarise the evidence regarding the relationship between dysphagia interventions and clinically important patient outcomes in acute and critical care settings. Methods We will search MEDLINE, EMBASE, CENTRAL, Web of Science, CINAHL and clinical trial registries from inception to the present. We will include studies conducted with adults in acute care settings such as acute hospital wards or units or intensive care units and critical care settings. Studies will be restricted to randomised controlled trials and quasi-randomised controlled trials comparing a new dysphagia intervention with usual care or another intervention. The main outcomes that will be collected include length of time taken to return to oral intake, change in incidence of aspiration and pneumonia, nutritional status, length of hospital stay and quality of life. Key intervention components such as delivery, intensity, acceptability, fidelity and adverse events associated with such interventions will be collected to inform future clinical trials. Two independent reviewers will assess articles for eligibility, data extraction and quality appraisal. A meta-analysis will be conducted as appropriate. Discussion No systematic review has attempted to summarise the evidence for oropharyngeal dysphagia interventions in acute and critical care. Results of the proposed systematic review will inform practice and the design of future clinical trials. Systematic review registration PROSPERO CRD 42018116849 (http://www.crd.york.ac.uk/PROSPERO/)

Likely country of origin in publications on randomised controlled trials and controlled clinical trials during the last 60 years

Trials ◽

10.1186/1745-6215-8-7 ◽

2007 ◽

Vol 8 (1) ◽

Cited By ~ 21

Author(s):

Christian Gluud ◽

Dimitrinka Nikolova

Keyword(s):

Clinical Trials ◽

Country Of Origin ◽

Controlled Trials ◽

Controlled Clinical Trials ◽

A Review of: “Interpreting and Reporting Clinical Trials: A Guide to the CONSORT Statement and the Principles of Randomised Controlled Trials, by A. Keech, V. Gebski, and R. Pike (eds.)”

Journal of Biopharmaceutical Statistics ◽

10.1080/10543400802071469 ◽

2008 ◽

Vol 18 (4) ◽

pp. 802-804 ◽

Cited By ~ 1

Author(s):

Steve Simon

Keyword(s):

Clinical Trials ◽

Consort Statement ◽

Controlled Trials ◽

The Consort Statement ◽

50 Tips for Clinical Trialists

Brain Impairment ◽

10.1017/brimp.2017.30 ◽

2017 ◽

Vol 19 (1) ◽

pp. 59-69 ◽

Cited By ~ 3

Author(s):

Lisa A. Harvey ◽

Joanne V. Glinsky ◽

Robert D. Herbert

Keyword(s):

Clinical Trials ◽

Controlled Trials ◽

This paper presents ‘Tips’ for researchers of brain impairment who are interested in conducting randomised controlled trials. The paper is intended for researchers who are planning to undertake their first trial, but may also be of interest to more experienced trialists or clinicians who want to further their understandings of clinical trials. The Tips include suggestions for how to design, conduct, analyse and report clinical trials.

Alternative approaches to endoscopic ablation for benign enlargement of the prostate: systematic review of randomised controlled trials

Clinical Governance An International Journal ◽

10.1108/cgij.2009.24814bae.004 ◽

2009 ◽

Vol 14 (2) ◽

Keyword(s):

Systematic Review ◽

Controlled Trials ◽

Endoscopic Ablation ◽

Alternative Approaches ◽

Clinical outcomes and outcome measurement tools reported in randomised controlled trials of treatment for snakebite envenoming: A systematic review

PLoS Neglected Tropical Diseases ◽

10.1371/journal.pntd.0009589 ◽

2021 ◽

Vol 15 (8) ◽

pp. e0009589

Author(s):

Michael Abouyannis ◽

Dinesh Aggarwal ◽

David G. Lalloo ◽

Nicholas R. Casewell ◽

Mainga Hamaluba ◽

...

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Outcome Measures ◽

Core Outcome Set ◽

Controlled Trials ◽

Study Protocols ◽

Outcome Set ◽

Secondary Analyses ◽

Background Snakebite is a priority neglected tropical disease and causes a range of complications that vary depending on the snake species. Randomised clinical trials have used varied outcome measures that do not allow results to be compared or combined. In accordance with the Core Outcomes Measurements in Effectiveness Trials (COMET) initiative, this systematic review aims to support the development of a globally relevant core outcome set for snakebite. Methods All randomised controlled trials, secondary analyses of randomised controlled trials and study protocols investigating the efficacy of therapeutics for human snakebite envenoming were eligible for inclusion. Study screening and data extraction were conducted in duplicate by two independent reviewers. All primary and secondary outcome measures were extracted and compiled, as were adverse event outcome measures. Similar outcome measures were grouped into domains. The study was prospectively registered with PROSPERO: CRD42020196160. Results This systematic review included 43 randomised controlled trials, two secondary analyses and 13 study protocols. A total of 382 outcome measures were extracted and, after duplicates were merged, there were 153 unique outcomes. The most frequently used outcome domain (‘venom antigenaemia’) was included in less than one third of the studies. The unique outcomes were classified into 60 outcome domains. Patient-centred outcomes were used in only three of the studies. Discussion Significant heterogeneity in outcome measures exists in snakebite clinical trials. Consensus is needed to select outcome measures that are valid, reliable, patient-centred and feasible. The results of this systematic review strongly support the development of a core outcome set for use in snakebite clinical trials.

Analysis and reporting of adverse events in randomised controlled trials: a review

BMJ Open ◽

10.1136/bmjopen-2018-024537 ◽

2019 ◽

Vol 9 (2) ◽

pp. e024537 ◽

Cited By ~ 19

Author(s):

Rachel Phillips ◽

Lorna Hazell ◽

Odile Sauzet ◽

Victoria Cornelius

Keyword(s):

Clinical Trials ◽

Adverse Events ◽

Hypothesis Testing ◽

Data Extraction ◽

Safety Data ◽

Multiple Hypothesis Testing ◽

Controlled Trials ◽

Reporting Practices ◽

ObjectiveTo ascertain contemporary approaches to the collection, reporting and analysis of adverse events (AEs) in randomised controlled trials (RCTs) with a primary efficacy outcome.DesignA review of clinical trials of drug interventions from four high impact medical journals.Data sourcesElectronic contents table of the BMJ, the Journal of the American Medical Association (JAMA), the Lancet and the New England Journal of Medicine (NEJM) were searched for reports of original RCTs published between September 2015 and September 2016.MethodsA prepiloted checklist was used and single data extraction was performed by three reviewers with independent check of a randomly sampled subset to verify quality. We extracted data on collection methods, assessment of severity and causality, reporting criteria, analysis methods and presentation of AE data.ResultsWe identified 184 eligible reports (BMJ n=3; JAMA n=38, Lancet n=62 and NEJM n=81). Sixty-two per cent reported some form of spontaneous AE collection but only 29% included details of specific prompts used to ascertain AE data. Numbers that withdrew from the trial were well reported (80%), however only 35% of these reported whether withdrawals were due to AEs. Results presented and analysis performed was predominantly on ‘patients with at least one event’ with 84% of studies ignoring repeated events. Despite a lack of power to undertake formal hypothesis testing, 47% performed such tests for binary outcomes.ConclusionsThis review highlighted that the collection, reporting and analysis of AE data in clinical trials is inconsistent and RCTs as a source of safety data are underused. Areas to improve include reducing information loss when analysing at patient level and inappropriate practice of underpowered multiple hypothesis testing. Implementation of standard reporting practices could enable a more accurate synthesis of safety data and development of guidance for statistical methodology to assess causality of AEs could facilitate better statistical practice.