Faculty Opinions recommendation of Placebos without deception: a randomized controlled trial in irritable bowel syndrome.

2011 ◽  
Author(s):  
David Triggle
Keyword(s):  
Randomized Controlled Trial ◽  
Irritable Bowel Syndrome ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Irritable Bowel

Digital instruments for reporting of gastrointestinal symptoms in clinical trials: comparison of end-of-day diaries versus experience sampling method (Preprint)

2021 ◽  
Author(s):  
Abraham B. Beckers ◽  
Johanna T.W. Snijkers ◽  
Zsa Zsa R.M. Weerts ◽  
Lisa Vork ◽  
Tim Klaassen ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Controlled Trial ◽  
Irritable Bowel Syndrome ◽  
Sampling Method ◽  
Sampling Methods ◽  
Controlled Trial ◽  
Smartphone Application ◽  
Randomized Controlled ◽  
Pre Treatment ◽  
Irritable Bowel

BACKGROUND Questionnaires are necessary tools for assessing symptoms of disorders of the brain-gut interaction in clinical trials. We previously reported on the excellent compliance to a smartphone app used as symptom diary in a randomized clinical trial in irritable bowel syndrome (IBS). Other sampling methods, such as the experience sampling method (ESM), are better equipped to measure symptom variability over time, provide useful information regarding possible symptom triggers and are free of ecological and recall bias. The high frequency of measurements, however, could limit the feasibility of ESM in clinical trials. OBJECTIVE This study aimed to compare compliance rates of a smartphone-based end-of-day diary and ESM for symptom assessment in irritable bowel syndrome and functional dyspepsia (FD). METHODS Data from four studies were included. Patients with IBS participated in a randomized controlled trial, which involved a smartphone end-of-day diary of 2+8 weeks (pre-treatment + treatment period), and an observational study, during which patients completed ESM assessments using a smartphone application for one week. Patients with FD participated in a randomized controlled trial, which involved a smartphone end-of-day diary of 2+12 weeks (pre-treatment + treatment period), and an observational study, during which patients completed ESM assessments using a smartphone application for one week. Compliance rates were compared between these two symptom sampling methods. RESULTS Twenty-five patients with IBS and fifteen patients with FD were included. Overall compliance rates for the end-of-day diaries were significantly higher than for ESM (IBS: 92.7% versus 69.8%, FD: 90.1% versus 61.4%, respectively). CONCLUSIONS We here demonstrate excellent compliance rates for smartphone application-based end-of-day diaries as used in two separate clinical trials. Overall compliance rates for ESM were significantly lower, rendering it more suitable for intermittent sampling periods rather than continuously during longer clinical trials.

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