Journal ArticleDOI
Validation of the phase II feasibility study in a palliative care setting: gastrografin in malignant bowel obstruction.
Cindy Lee,Ryash Vather,Anne O'Callaghan,Jackie Robinson,Briar McLeod,Michael Findlay,Ian P. Bissett +6 more
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TLDR
This study validates the use of the phase II feasibility study to assess protocol viability in a palliative population prior to embarking on a larger trial.Abstract:
Background:Malignant bowel obstruction (MBO) is common in patients with advanced cancer.Aim:To perform a phase II study to assess the feasibility of conducting a phase III trial investigating the therapeutic value of gastrografin in MBO.Methods:Randomized double-blinded placebo-controlled feasibility study. Participants received 100 mL of either gastrografin or placebo.Results:Over 8 months, 57 patients were screened and 9 enrolled (15.8% recruitment rate). Of the 9 enrolled, 4 received gastrografin (with 2 completing assessment) and 5 received placebo (with 4 completing assessment).Conclusions:It is not feasible to conduct a phase III trial using the same study protocol. This study validates the use of the phase II feasibility study to assess protocol viability in a palliative population prior to embarking on a larger trial.read more
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Gastrografin in Prolonged Postoperative Ileus: A Double-blinded Randomized Controlled Trial.
TL;DR: Gastrografin is not clinically useful in shortening an episode of PPOI characterized by upper and lower gastrointestinal symptoms, but may be of therapeutic benefit in the subset of P POI patients who display lower gastrointestinal Symptoms exclusively after surgery.
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Using the 'Social Marketing Mix Framework' to explore recruitment barriers and facilitators in palliative care randomised controlled trials? A narrative synthesis review.
TL;DR: The ‘Social Marketing Mix Framework’ can help guide researchers when planning and implementing their recruitment strategy but suggested strategies need to be tested within embedded clinical trials.
Journal ArticleDOI
Oral water soluble contrast for malignant bowel obstruction.
TL;DR: There is insufficient evidence from RCTs to determine the place of OWSC in predicting which patients with inoperable MBO will respond with conservative treatment alone, and this review found only one RCT meeting the selection criteria for the second objective of this review.
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Feasibility and Pilot Studies in Palliative Care Research: A Systematic Review
TL;DR: A gold standard for feasibility study design in palliative care research that includes both clear criteria for success and testing of the study protocol for participant acceptability and burden is needed.
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Are the MORECare guidelines on reporting of attrition in palliative care research populations appropriate? A systematic review and meta-analysis of randomised controlled trials.
TL;DR: Reporting the cause of attrition is useful in helping to understand trial results, and Prospective reporting using the MORECare classifications should improve the understanding of future trials.
References
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CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials
TL;DR: The Consort 2010 Statement as discussed by the authors has been used worldwide to improve the reporting of randomised controlled trials and has been updated by Schulz et al. in 2010, based on new methodological evidence and accumulating experience.
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How We Design Feasibility Studies
Deborah J. Bowen,Matthew W. Kreuter,Bonnie Spring,Ludmila M Cofta-Woerpel,Laura A. Linnan,Diane Weiner,Suzanne Bakken,Cecilia Patrick Kaplan,Linda Squiers,Cecilia Fabrizio,Maria E. Fernandez +10 more
TL;DR: The diverse types of feasibility studies conducted in the field of cancer prevention, using a group of recently funded grants from the National Cancer Institute are described.
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The Edmonton Symptom Assessment System (ESAS): a simple method for the assessment of palliative care patients.
TL;DR: It is concluded that this is a simple and useful method for the regular assessment of symptom distress in the palliative care setting.
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Validation of the Edmonton Symptom Assessment Scale.
TL;DR: The Edmonton Symptom Assessment Scale (ESAS) is a nine‐item patient‐rated symptom visual analogue scale developed for use in assessing the symptoms of patients receiving palliative care and validated in a different population of patients.
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From margins to centre: a review of the history of palliative care in cancer
TL;DR: Palliative care services have developed in many settings and have often been closely related to oncology as discussed by the authors, and the worldwide need for this type of care remains much greater than the available provision, but there are encouraging signs of recognition by policymakers and influential bodies.