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

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ClinicalTrials.gov Identifier: NCT03461497
Recruitment Status : Recruiting
First Posted : March 12, 2018
Last Update Posted : August 20, 2019
Sponsor:
Collaborators:
Hospital São Paulo, Brazil
Hokkaido University Hospital
San Raffaele University Hospital, Italy
Information provided by (Responsible Party):
Julio F Fiore Jr, McGill University Health Centre/Research Institute of the McGill University Health Centre

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.


Condition or disease
Abdominal Surgery

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.

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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
Patients Cohort
Patients undergoing abdominal surgery



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



Information from the National Library of Medicine

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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
Study Population
Patient's that have undergone abdominal surgery
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

Information from the National Library of Medicine

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


Contacts
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Contact: Julio F Fiore Jr, PhD 514-934-1934 ext 48475 julio.fiorejunior@mcgill.ca

Locations
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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   
Sponsors and Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre
Hospital São Paulo, Brazil
Hokkaido University Hospital
San Raffaele University Hospital, Italy
Investigators
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Principal Investigator: Julio F Fiore Jr, PhD McGill University, Department of Surgery
Principal Investigator: Liane S Feldman, MD McGill University, Department of Surgery

Publications:
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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: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Julio F Fiore Jr, McGill University Health Centre/Research Institute of the McGill University Health Centre:
Patient-Reported Outcome
Patient Outcome Assessment
Questionnaire
Self-Report
Abdominal Surgery
Postoperative Period
Recovery of Function
Psychometrics
Qualitative Research
Patient-Centered