A Systematic Review and Meta-Analysis (SRMA) was conducted to quantify the pooled level of patient knowledge and perception towards informed consent and determinants among surgical patients in Ethiopia. A preliminary assessment was done to check whether a similar study was performed or not through Prospero, Epistemonikos, Semantic Scholar, and PubMed and there was no similar study. We prepared this systematic review and meta-analysis according to the preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA-2020) follow diagrams (S1 Table 1). The protocol was registered at Prospero with number CRD42023445409 and is available from: https://www.crd.york.ac.uk/PROSPERO/#myprospero.

We searched major databases such as PubMed, Hinary, MEDLINE, Cochrane Library, EMBASE, Scopus, African Journal Online (AJO), Semantic Scholar, Google Scholar, google, and reference lists. Besides this, University databases in the country were also searched from August 20, 2023, until September 30, 2023,. Studies conducted between January 01, 2015 to September 30, 2023, were included.

This systematic review and meta-analysis used PECO (Population, Exposure, Comparison, and outcome) to identify eligible studies. The study population (P) are surgical patients, exposure (E) associated factors, comparison (C) reference of the factors, and outcome (O) level of knowledge and perception towards informed consent. Boolean operators “OR” and “AND” were used to combine search terms. Keywords used to search includes knowledge, perception, patient, client, “informed consent”, consent, factors, determinants, predictors, “surgical patient”, “post operated patient”, “after surgery”, and Ethiopia.

Studies obtained by the reviewers’ search strategy were exported into EndNote for management. All duplicated studies obtained for different database searches were excluded. Studies eligibility was assessed first from the title, then the abstract, and finally, a full-text review was performed.

All observational studies (cross-sectional, case-control, and cohort) on patient knowledge and perception towards informed consent among surgical patients conducted in Ethiopia were included. Both published and unpublished studies reported the prevalence of patient knowledge and perception toward informed consent and its associated factors were included. All studies reported in English were included. Studies conducted between January 01, 2015 to September 30, 2023 were included. Articles that cannot access full text after failing to contact the primary authors were excluded.

This systematic review and meta-analysis measured three main outcomes. The first outcome of the study was to estimate the pooled level of appropriate knowledge towards informed consent. The second outcome was to estimate the pooled level of perception towards informed consent. The third outcome was the associated factors with knowledge of informed consent among surgical patients. The level of knowledge towards informed consent was measured by 12 items and the level of perception by 8 items of questions. Patients who scored less than the mean for knowledge and perception questions had poor knowledge and poor perception respectively.

The selection of studies in all the searched databases was conducted by three authors (YT, NK, and FDB) independently. The primary author, study year, year of publication, regions where the study was done, study design, sample size, prevalence, response rate, method of outcome measurement, all associated factors odds ratio, relative risk, lower confidence interval, and upper confidence interval were extracted by using Microsoft Excel format. The corresponding author was supportive of clarification on the inclusion criteria. Disagreements among data extractors were solved by consensus.

Three reviewers (MMM, NK, and YT) independently screened the articles that fulfilled the inclusion criteria to avoid the risk of bias. The Newcastle-Ottawa Scale (NOS) checklist was used to appraise the quality of the studies. The tool includes three parts. The first part included methodology [5] rate with five stars, the second part was comparability [2] rate with two stars and the third part was outcome with statistical test [3] rate with three stars (S2 Table). Three authors (MMM, NK, and YT) independently assessed the quality of the studies. Disagreements among reviewers were resolved by consensus and a third party (FDB).

Data were extracted by using Microsoft Excel format and imported into STATA version 17 for processing and analysis. The pooled prevalence of patient knowledge and perception towards informed consent was estimated by random effect model meta-analysis. The heterogeneity of the studies was assessed by observing the p-value and I2 statistics test. Factors associated with patient knowledge for informed consent were estimated by a log odds ratio at 95% CI. The potential source of heterogeneity was identified by subgroup analysis. In addition, Egger’s test statics and funnel plot were performed to identify potential publication bias among the included studies. The result of this meta-analysis was presented by tables, funnel plots, forest plots, and narrations.