Evaluation of the Gastroparesis Cardinal Symptom Index in PD

• Research type

  Research Study

• Full title

  Content Evaluation of the Gastroparesis Cardinal Symptom Index-Daily Diary for Use in Patients Diagnosed with Parkinson’s Disease and Gastroparesis

• IRAS ID

  103722

• Contact name

  Anton Emmanuel

• Contact email

  a.emmanuel@ucl.ac.uk

• Sponsor organisation

  Glaxo Smith Kline

• Research summary

  The purpose of this study is to evaluate the use of the Gastroparesis Cardinal Symptom Index-Daily Diary (GCSI-DD) instrument to assess patient-reported symptoms of gastroparesis in patients diagnosed with Parkinson’s disease (PD) and gastroparesis. Qualitative interviews will be conducted in two phases with PD patients.

  Phase I, will be used to evaluate the comprehensiveness and relevance of items within the GCSI-DD PRO instrument to assess symptoms of gastroparesis in patients with a dual diagnosis of gastroparesis/PD for use in upcoming clinical trials.
  In Phase II, the instrument will be further tested using cognitive interview methodology to evaluate changes made to the instrument. Clinically diagnosed PD patients over 40 years of age with clinically diagnosed gastroparesis (approximately 20 patients will be interivewed as a one time event in Phase I, another 15 patients will be interviewed as a one time event in Phase II for a total of 35 patients overall) will be screened by trained staff from clinics at National Hospital for neurology and neurosurgery. The participants found suitable will be approached to discuss the study and recruited based on the predefined inclusion and exclusion criteria. The partcipants will have qualitative interviews using current GCSI-DD (Phase I) and modified version of the GCSI-DD (Phase II), if necessary. At the end of the interview, all participants will also complete the GCSI measure (2-week recall) and a socio-demographic and clinical questionnaire. All participants will provide written informed consent and will be reimbursed for travel expenses (not to exceed 50 GBP). The interview data (transcribed dialogue) will be analysed using ATLAS.ti version 5.5 using a saturation grid to document emergent concepts from these interviews will be developed.

• REC name

  North West - Greater Manchester East Research Ethics Committee

• REC reference

  13/NW/0798

• Date of REC Opinion

  17 Dec 2013

• REC opinion

  Further Information Favourable Opinion