Patients-reported-outcome for Achalasia Symptom Score
Research type
Research Study
Full title
An International Patients-reported-outcome tool for Achalasia Symptom Score
IRAS ID
267141
Contact name
Sheraz Markar
Contact email
Sponsor organisation
Imperial College London
Clinicaltrials.gov Identifier
19SM5619,
Duration of Study in the UK
1 years, 6 months, 2 days
Research summary
Background:
Achalasia is an oesophageal disease characterized by the absence of opening of the cardia at swallowing. Consequently, the food/liquid gets stuck in the gullet and patients experience dysphagia, regurgitation and chest pain. Treatment of achalasia consists of opening the cardia either by dilatation, surgery or paralysis of the muscle with botulinum toxin. Treatment efficacy is evaluated by symptom improvement, however, at present, there is no validated tool to objectively measure symptoms. To fill this gap we have developed a self-administered questionnaire through a Delphi consensus with 17 experts and refined it with cognitive interviews in 10 patients. We have calculated that to determine the threshold to define failure of a treatment as the 95th percentile of the lower score of non treated achalasia patients, we need to recruit 720 achalasia patients. The aims of this pilot study are to establish the acceptance rates of the questionnaire by patients and to capture the time needed to fill in the questionnaires of the study, in order to ultimately design a larger internationally based study.Methods:
The questionnaire will be tested on fifty consecutive achalasia naive patients at Imperial College, UCL, Barts Health and King’s College NHS trusts. Questionnaires will be administered during the final visit before treatment, by a registered nurse that will record the agreement of patients to participate in the study and the time required to fill in the questionnaires- the I-Pass questionnaire, a questionnaire on quality of life (SF-36) and the Eckardt achalasia score (a non-validated, but widely used tool). Physiological data (manometry) and barium swallow results will be retrieved from the patient’s hospital chart.Patients who are neurologically impaired, have psychiatric problems or are not fluent in English will be excluded.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
20/EM/0167
Date of REC Opinion
21 Jul 2020
REC opinion
Further Information Favourable Opinion