The South African Collaborative Surgical Outcomes Study (SACSOS) (SACSOS)

A Prospective Observational Cohort Study of Patient-reported Outcomes After Surgery Using a Digital Health Platform

Improving quality of perioperative care depends on reliable measurement of clinically important and patient-centred data, that will allow collaborative decision-making between patient and clinician. The use of digital health tools to share person-centric data with the aim of improving quality of care is encouraged by the World Health Organization Global Strategy on Digital Health. With virtual and online communication becoming a universal feature of modern life, there is a promising opportunity to engage patients and clinicians in perioperative data collection using digital health platforms. The Perioperative Shared Health Record (PSHR), developed by Safe Surgery South Africa, provides the opportunity to capture standardised patient-centric postoperative outcomes measures, like Quality of Recovery (QOR), Health Related Quality of Life (HRQOL), the WHO Disability Assessment Schedule (WHODAS). These are all standardised measures and questionnaires, which have been recommended by working groups focused on the patient's experience after surgery. The PSHR enables sharing of data between the surgical patient and his/her clinical team (surgeons and anaesthetists).

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Complications
• Intervention / Treatment: Other: Public or Private Sector Patients

Detailed Description

SACSOS is a patient-centered prospective observational cohort study.

Initially, clinical teams in the South African private health care sector will be approached. In later phases of the study, recruitment will include eligible patients in the South African public health care sector.

Patient engagement and -participation will be sought during the recruitment process by engaging with the clinical team (surgeon, anaesthetist, hospital clinical manager) for individual patient care (at a micro level); in data collection using a patient-centric platform; and in the follow up after surgery. Data will be collected by patients using a digital platform, the Perioperative Shared Health Record (PSHR). De-identified data will be extracted from the database at predetermined intervals and made available to the principal investigator for analysis.

The PSHR will be updated to optimise health information exchange between the surgical patient and clinical team members during the study.

Participation from health care providers will be in a team-based approach, including surgeon(s) and/or anaesthetist(s) at each specific center. A core group of participating centers will be identified.

The study will focus on patient participation with the web-based platform as the primary recruitment method. This will reduce the need for clinician input, and promote greater patient-centeredness. Patient participation and data capturing require internet access to the web-based platform.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Hyla-Louise Kluyts, DMed; Phone Number: 27836803839; Email: hyla.kluyts@smu.ac.za
• Study Contact Backup: Name: Charle Steyl, FCA; Phone Number: 27848000904; Email: 201710494@swave.smu.ac.za

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

To enable a patient-centred approach, patients will be invited to participate in the study by a member of the clinical team responsible for their care. Initially, clinical teams in the South African private health care sector will be approached. In later phases of the study, recruitment will include eligible patients in the South African public health care sector.

Description

Inclusion Criteria:

• Adult patients presenting for any surgical procedure at South African hospitals during the specified study period.

Exclusion Criteria:

• Patients unable to provide consent to participation.
• Patients whose legal guardian is unable to provide consent to participation (if applicable).
• Patients unable to nominate next-of-kin, guardian of or a person of their choice, as their representative during follow-up.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients within the private healthcare sector; Patients from private sector hospitals in South Africa accommodating the use of the Bespoke Surgical Institute (BSI) Deep Health clinical data platform.	Other: Public or Private Sector Patients; No intervention will be done. Two groups of patients will be recruited: patients receiving surgery in the Private Healthcare Sector, and patients receiving surgery in the Public Healthcare Sector
Patients within the public healthcare sector.; Patients admitted for surgery at Dr George Mukhari Academic Hospital, Gauteng Department of Health.	Other: Public or Private Sector Patients; No intervention will be done. Two groups of patients will be recruited: patients receiving surgery in the Private Healthcare Sector, and patients receiving surgery in the Public Healthcare Sector

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To describe the relationship between preoperative and 6-month postoperative health-related quality of life in South African surgical patients.	Health Related Quality of Life, measured with the EQ-5D-5L score, preoperatively and at 6 months postoperatively	6 Months post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To describe the relationship between patient comorbidities, surgical characteristics and postoperative patient- reported outcomes measures (quality of recovery, health-related quality of life).	Quality of recovery (QoR) preoperatively and at 24-48 hours postoperatively	24-48 hours postoperatively
To assess data quality (accuracy) of the adapted patient-reported POMS by comparison with completed provider POMS.	Amended Postoperative Morbidity Survey (POMS) postoperatively after 5 days	5 days postoperatively
To compare data quality (completeness) for patient-reported outcomes and provider POMS between public and private sector settings.	POMS recorded by surgeon at discharge from hospital after surgical procedure	5-7 days postoperatively

Collaborators and Investigators

• Sponsor: Sefako Makgatho Health Sciences University
• Collaborators: University of Cape Town; Medical Research Council, South Africa
• Investigators: Principal Investigator: BRUCE BICCARD, PhD, University of Cape Town; Principal Investigator: Hyla-Louise Kluyts, DMed, Sefako Makgatho Health Sciences University

Publications and helpful links

Helpful Links

• Website for Safe Surgery South Africa. Surgery South Africa, a non-profit company (NPC) will act as custodian of data captured using the Perioperative Shared Health Record (PSHR) platform.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: September 14, 2021
• First Submitted That Met QC Criteria: September 17, 2021
• First Posted (Actual): September 22, 2021

Study Record Updates

• Last Update Posted (Actual): May 23, 2025
• Last Update Submitted That Met QC Criteria: May 19, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Outcome measures; Patient-centered care; Peri-operative care
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: SMUREC/M/184/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No