Conectar
External control arms (ECAs) provide useful comparisons in clinical trials when randomised control arms are limited or not feasible. We conducted a systematic review to summarise applications of ECAs in trials of immune-mediated inflammatory diseases (IMIDs).
Systematic review with an appraisal of ECA source quality rated across five domains (data collection, study populations, outcome definitions, reliability and comprehensiveness of the dataset, and other potential limitations) as high, low or unclear quality.
Embase, Medline and Cochrane Central Register of Controlled Trial were searched through to 12 September 2023.
Eligible studies were single-arm or randomised controlled trials (RCTs) of inflammatory bowel disease, pouchitis, rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis and atopic dermatitis in which an ECA was used as the comparator.
Two authors independently screened the search results in duplicate. The characteristics of included studies, external data source(s), outcomes and statistical methods were recorded, and the quality of the ECA data source was assessed by two independent authors.
Forty-three studies met the inclusion criteria (inflammatory bowel disease: 16, pouchitis: 1, rheumatoid arthritis: 12, juvenile idiopathic arthritis: 1, ankylosing spondylitis: 5, psoriasis: 3, multiple indications: 4). The majority of these trials were single-arm (33/43) and enrolled adult patients (34/43). All included studies used a historical control rather than a contemporaneous ECA. In RCTs, ECAs were most often derived from the placebo arm of another RCT (6/10). In single-arm trials, historical case series were the most common ECA source (19/33). Most studies (31/43) did not employ a statistical approach to generate the ECA from historical data.
Standardised ECA methodology and reporting conventions are lacking for IMIDs trials. The establishment of ECA reporting guidelines may enhance the rigour and transparency of future research.
Nursing interventions in the post-operative time period including psychological and emotional support, adverse event education, and instructions for follow-up care contribute patient satisfaction, safety, and quality of life. However, the time spent in the post-anesthesia care unit (PACU) and hospital continues to shorten around the world to reduce health care spending and improve patient outcomes. Nurses conducting research during the important post-operative recovery period need to utilize unique techniques and emerging technologies to contact, recruit and collect data outside of the hospital setting including the Research Electronic Data Capture (REDCap) platform.
This paper describes the feasibility and acceptability, facilitators and barriers of the software application, REDCap, to complete a repeated-measures, descriptive correlational study in patients undergoing outpatient breast cancer surgeries.
The recruitment, data collection and storage were completed utilizing the secure REDCap Platform. The Institutional Research Board (IRB)-approved study was a repeated-measures, descriptive, correlational study with data collection at three time points. The data points aligned with important transitions and routine visits to improve data collection feasibility and increase relevance to clinical practice.
The sample consisted of women diagnosed with breast cancer undergoing breast conserving surgery between August 15 and October 15, 2020. There were 123 potential participants, of which 76 started the surveys and 75 participated (61%) responded and participated in the study on Post-operative Day 1. Fifty-nine participants (78%) completed the surveys on post-operative Day 14.
As the frequency of outpatient treatment increases, nurses conducting post-operative research will need to collect the data outside of the hospital setting.
Email provides a method of studying new phenomena by recruiting participants, providing information about the study, and collecting results in a non-traditional setting. REDCap provides a method to facilitate nursing research through a securely encrypted integrated process.
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