The South African Collaborative Surgical Outcomes Study (SACSOS)
- Conditions
- Postoperative Complications
- Interventions
- Other: Recent or Peri-Operative Covid19 Infection
- Registration Number
- NCT05052021
- Lead Sponsor
- Sefako Makgatho Health Sciences University
- Brief Summary
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 1000
- Adult patients presenting for any surgical procedure at South African hospitals during the specified study period.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Perioperative or Recent Covid19 Infection Recent or Peri-Operative Covid19 Infection Patients will be classified as having Perioperative Covid19 Infection if they test positive for SARS-CoV-2 within 7 days before and 30 days after surgery. Patients will be classified as having Recent Covid19 infection if they tested positive for Covid19 within 1-6 weeks before surgery. These patients will be analysed together as a group, as it is likely that their risk for complications will be similar.
- Primary Outcome Measures
Name Time Method To describe the relationship between preoperative and 6-month postoperative health-related quality of life in South African surgical patients. 6 Months post-operatively Health Related Quality of Life, measured with the EQ-5D-5L score, preoperatively and at 6 months postoperatively
- Secondary Outcome Measures
Name Time Method To describe the relationship between patient comorbidities, surgical characteristics and postoperative patient- reported outcomes measures (quality of recovery, health-related quality of life). 24-48 hours postoperatively Quality of recovery (QoR) preoperatively and at 24-48 hours postoperatively
To assess data quality (accuracy) of the adapted patient-reported POMS by comparison with completed provider POMS. 5 days postoperatively Amended Postoperative Morbidity Survey (POMS) postoperatively after 5 days
To compare data quality (completeness) for patient-reported outcomes and provider POMS between public and private sector settings. 5-7 days postoperatively POMS recorded by surgeon at discharge from hospital after surgical procedure