Abbott Pharma

Development of a Patient-Reported Outcome Measure to Assess Recovery After Abdominal Surgery

Recruitment Status: Recruiting
Study Sponsor:
McGill University Health Center
Responsible Party:
Julio F Fiore Jr

First Submitted Date: Mar 02, 2018
First Posted Date: Mar 12, 2018
Last Update Posted Date: Mar 12, 2018
Estimated Study Start Date: Jul 01, 2016
Estimated Primary Completion Date: Jun 01, 2021

Primary Outcome Measures: Patient-Reported Outcome Measure (PRO)[Time Frame: 3 years]
PRO measure of recovery after abdominal surgery

Secondary Outcome Measures: Not Provided
Other Outcome Measures: Not Provided
Descriptive Information
Brief Title: Development of a Patient-Reported Outcome Measure to Assess Recovery After Abdominal Surgery
Official Title: Value-Based Care in Abdominal Surgery: Measuring Recovery Outcomes That Matter to Patients
Brief Summary: As surgery enters the era of value-based care, it is advocated that postoperative recovery be measured using patient-reported outcomes (PROs) as they provide a mean to incorporate the patient's perspectives and experiences into research and clinical decision-making. In abdominal surgery, this is currently precluded by the lack of PRO measures specifically developed and validated in the context of postoperative recovery. The core goal of this research project is to develop a PRO measure aimed to assess postoperative recovery from the perspective of patients undergoing abdominal surgery. This project complies with the US Food and Drug Administration (FDA) and International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guidelines for PRO development and will be conducted in three phases: Phase 1: Qualitative interviews with patients to develop a conceptual framework and generate relevant items. Phase 2: Use of Rasch Analysis for item-reduction and scale formation. Phase 3: Further assessment of measurement properties based on traditional psychometric methods.
Detailed Description: OBJECTIVE: To develop a comprehensive, conceptually relevant and psychometrically sound PRO measure to assess recovery after abdominal surgery. OUTLINE: - Phase 1(Conceptual framework and item generation): Semi-structured interviews focusing on patient lived experiences after abdominal surgery are currently being conducted to derive the "final conceptual framework of recovery after abdominal surgery". The interviews are guided by the "hypothesized conceptual framework" which is based on previous literature and expert input. This phase has a minimal targeted sample of 30 patients. To account for potential cross-cultural differences in recovery experiences, the study is enrolling patients from 5 international sites: McGill University Health Centre (Montreal, Canada), Hospital Sao Paulo (Sao Paulo, Brazil), Vita-Salute San Raffaele Hospital (Milan, Italy, Hokkaido University Hospital (Sapporo, Japan) and Hospital (TBE, USA). Interview audio recordings are transcribed, translated if required, and coded according to ICF (International Classification of Functioning, Disability and Health) domains. Codes for which saturation is reached will comprise the final conceptual framework of recovery. Items reflecting the essence of each domain will be generated and patient understanding of the items will be assessed through cognitive interviews. Items for which no problems have been identified and those successfully revised will be compiled into an item pool to be 'calibrated' in subsequent stages of PRO development. - Phase 2: (Rasch Analysis): Estimate the extent to which the pool of items generated in Phase 1 fit the Rasch model and, based on this analysis, modify or eliminate items to ensure that the novel PRO measure fits a linear continuum and produces meaningful scores. Phase 2 targets a sample of 300 patients and the preliminary item pool will be administered at one time point either in pen-and-paper format or using an online survey, depending on the patient's preference. Based on the analysis, a computer adaptive testing (CAT) system will be developed to allow accurate measurement of PRO scores using a minimal number of items. - Phase 3: (Validation using traditional psychometric methods ): Use traditional psychometric methods to contribute further evidence regarding the measurement properties of the novel PRO measure of recovery after abdominal surgery. To do so, the final PRO measure in CAT format will be administered to a consecutive cohort of patients undergoing abdominal surgery (target sample size of 200) in two institutions (MUHC and Florida Hospital) preoperatively and at postoperative days 3, 7, 15, 30 and 90.
Study Type: Observational
Study Phase: Not Provided
Study Design: Allocation: Not Provided

Intervention Model: Not Provided

Intervention Model Description: Not Provided

Study Masking: Not Provided

Study Masking Description: Not Provided

Study Primary Purpose: Not Provided
Condition: Abdominal Surgery
Intervention: Not Provided
Study Arms: : Patients Cohort
Patients undergoing abdominal surgery

Recruitment Information
Recruitment Status: Recruiting
Estimated Enrollment: 530
Estimated Study Completion Date: Jun 01, 2021
Eligibility Criteria: The following applies to all phases of the project. Inclusion Criteria: - Age ?18 years old - Abdominal surgery within three days to three months before enrolment - Fluent in the local language - Willing and able to provide written informed consent Exclusion Criteria: - Documented mental impairment - Palliative care - Advanced musculoskeletal, neurological, pulmonary or cardiac disorders - Organ transplantation - Cesarean section
Sex/Gender: All
Ages: 18 Years to N/A
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Contacts: Name: Julio F Fiore Jr, PhD
Phone: 514-934-1934
Listed Location Country: Brazil
NCT Number: NCT03461497
Has Data Monitoring Committee: No
U.S. FDA-regulated Product: Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.:
IPD Sharing Statement: Plan to Share IPD: Undecided
Plan Description: Not Provided
Plan Time Frame: Not Provided
Plan Access Criteria: Not Provided
Responsible Party: Principal Investigator
Study Sponsor: McGill University Health Center
Collaborators: Not Provided
Investigators: Not Provided
PRS Account: McGill University Health Center
Verification Date: Mar 01, 2018