The South African Collaborative Surgical Outcomes Study (SACSOS)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Public or Private Sector Patients.
- Who it may be relevant to
- Registry conditions: Postoperative Complications. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective Observational Cohort Study of Patient-reported Outcomes After Surgery Using a Digital Health Platform
Overview
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).
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.
Interventions
- 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
Primary outcome measures
- To describe the relationship between preoperative and 6-month postoperative health-related quality of life in South African surgical patients. [Time frame: 6 Months post-operatively]
Secondary outcome measures (3)
- To describe the relationship between patient comorbidities, surgical characteristics and postoperative patient- reported outcomes measures (quality of recovery, health-related quality of life). [Time frame: 24-48 hours postoperatively]
- To assess data quality (accuracy) of the adapted patient-reported POMS by comparison with completed provider POMS. [Time frame: 5 days postoperatively]
- To compare data quality (completeness) for patient-reported outcomes and provider POMS between public and private sector settings. [Time frame: 5-7 days postoperatively]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT05052021 · SMUREC/M/184/2020