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

Abdominal Surgery Clinical Trial

Official title:

Value-Based Care in Abdominal Surgery: Measuring Recovery Outcomes That Matter to Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03461497
• Other study ID #: VT 57203
• Status: Active, not recruiting
• Start date: July 2016
• Est. completion date: December 2025

Study information

• Verified date: November 2023
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 100 patients (measured at 5 timepoints) 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 530
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Surgery

Locations

Country	Name	City	State
Brazil	Hospital São Paulo	São Paulo
Canada	Montreal General Hospital	Montreal	Quebec
Italy	San Raffaele Hospital	Milano
Japan	Hokkaido University Hospital	Sapporo	Hokkaido

Sponsors (4)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre	Hokkaido University Hospital, Hospital São Paulo, Brazil, San Raffaele University Hospital, Italy

Countries where clinical trial is conducted

Brazil,  Canada,  Italy,  Japan, 

References & Publications (1)

Fiore JF Jr, Figueiredo S, Balvardi S, Lee L, Nauche B, Landry T, Mayo NE, Feldman LS. How Do We Value Postoperative Recovery?: A Systematic Review of the Measurement Properties of Patient-reported Outcomes After Abdominal Surgery. Ann Surg. 2018 Apr;267(4):656-669. doi: 10.1097/SLA.0000000000002415. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient-Reported Outcome Measure (PRO)	PRO measure of recovery after abdominal surgery	3 years