Development of a Patient-Reported Outcome Measure to Assess Recovery After Abdominal Surgery
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| ClinicalTrials.gov Identifier: NCT03461497 |
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Recruitment Status :
Recruiting
First Posted : March 12, 2018
Last Update Posted : September 1, 2020
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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.
| Condition or disease |
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| Abdominal Surgery |
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 |
| Estimated Enrollment : | 530 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Value-Based Care in Abdominal Surgery: Measuring Recovery Outcomes That Matter to Patients |
| Actual Study Start Date : | July 2016 |
| Estimated Primary Completion Date : | December 2021 |
| Estimated Study Completion Date : | December 2021 |
| Group/Cohort |
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Patients Cohort
Patients undergoing abdominal surgery
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- Patient-Reported Outcome Measure (PRO) [ Time Frame: 3 years ]PRO measure of recovery after abdominal surgery
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03461497
| Contact: Julio F Fiore Jr, PhD | 514-934-1934 ext 48475 | julio.fiorejunior@mcgill.ca |
| Brazil | |
| Hospital São Paulo | Completed |
| São Paulo, Brazil, 04024-002 | |
| Canada, Quebec | |
| Montreal General Hospital | Active, not recruiting |
| Montreal, Quebec, Canada, H3G 1A4 | |
| Italy | |
| San Raffaele Hospital | Completed |
| Milano, Italy, 20132 | |
| Japan | |
| Hokkaido University Hospital | Recruiting |
| Sapporo, Hokkaido, Japan, 060-8648 | |
| Contact: Yusuke Watanabe, MD ywatanabe328@gmail.com | |
| Principal Investigator: | Julio F Fiore Jr, PhD | McGill University, Department of Surgery | |
| Principal Investigator: | Liane S Feldman, MD | McGill University, Department of Surgery |
| Responsible Party: | Julio F Fiore Jr, Assistant Professor, McGill University Health Centre/Research Institute of the McGill University Health Centre |
| ClinicalTrials.gov Identifier: | NCT03461497 |
| Other Study ID Numbers: |
VT 57203 |
| First Posted: | March 12, 2018 Key Record Dates |
| Last Update Posted: | September 1, 2020 |
| Last Verified: | August 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Patient-Reported Outcome Patient Outcome Assessment Questionnaire Self-Report Abdominal Surgery |
Postoperative Period Recovery of Function Psychometrics Qualitative Research Patient-Centered |