Browsing by Subject "Informed consent"

Now showing 1 - 4 of 4
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    Does the use of video improve patient satisfaction in the consent process for local-anaesthetic urological procedures?
    (2021) Moore, Allison Louise; Howlett, Justin
    Purpose To assess patient satisfaction with the use of Portable Video Media (PVM) for the purpose of taking informed consent for common urological outpatient procedures performed under local anaesthesia. Methods Patients undergoing the following procedures were approached for recruitment: flexible cystoscopy with or without biopsy, transrectal ultrasound-guided prostate biopsy or flexible cystoscopy with insertion or removal of a ureteric stent. Audio-visual media were developed for each procedure, with each script translated from English into isiXhosa and Afrikaans. The study involved a cross-over for each patient between Standard Verbal Consent (SVC) and PVM consent, with each patient randomised to start with SVC or PVM consent. Each of these consent-arms were assessed via a questionnaire. Results 60 patients completed participation, with PVM as the first exposure for 28 patients and 32 patients receiving SVC as their first arm of the study. When comparing the overall satisfaction between SVC and PVM consent (the total scores out of 18 for the questionnaire), patients scored significantly higher for PVM consent (M = 16.3 ± 2.4) compared to SVC (M = 15.4 ± 2.9) (p = 0.002). 92% of the total patient sample preferred PVM consent. Conclusion PVM proved superior to SVC in improving satisfaction in the consent process for common outpatient urological procedures performed under local anaesthesia.
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    Open Access
    Ethical issues in genomic research on the African continent: experiences and challenges to ethics review committees
    (2014-08-21) Ramsay, Michèle; de Vries, Jantina; Soodyall, Himla; Norris, Shane A; Sankoh, Osman
    Abstract This is a report on a workshop titled ‘Ethics for genomic research across five African countries: Guidelines, experiences and challenges’, University of the Witwatersrand, Johannesburg, South Africa, 10 and 11 December 2012. The workshop was hosted by the Wits-INDEPTH partnership, AWI-Gen, as part of the H3Africa Consortium.
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    “I passed the test!” Evidence of diagnostic misconception in the recruitment of population controls for an H3Africa genomic study in Cape Town, South Africa
    (BioMed Central, 2017-02-15) Masiye, Francis; Mayosi, Bongani; de Vries, Jantina
    Background: Advances in genetic and genomic research have introduced challenges in obtaining informed consent for research in low and middle-income settings. However, there are only few studies that have explored challenges in obtaining informed consent in genetic and genomic research in Africa and none in South Africa. To start filling this gap, we conducted an empirical study to investigate the efficacy of informed consent procedures for an H3Africa genomic study on Rheumatic Heart Disease (RHDGen) at the University of Cape Town in South Africa. The main aim of the study was to understand ethical challenges in obtaining informed consent in the RHDGen study. Methods: We used a qualitative study methodology involving in-depth interviews and participant observations. Our study participants were RHDGen cases (patients), healthy controls and research staff involved in the recruitment of RHDGen cases and controls. In total, we conducted 32 in-depth interviews with RHDGen cases and controls, 2 in-depth interviews with research staff and 57 direct observations of the consent procedures of RHDGen cases and controls. The interviews were conducted in English, audio-recorded and transcribed verbatim. Data were analyzed using thematic content analysis. The study was conducted in 3 sites within Cape Town, South Africa. Results: Most healthy controls joined the RHDGen study in order to be screened for rheumatic heart disease (diagnostic misconception). A majority of RHDGen cases decided to join the RHDGen study because of therapeutic misconception. Conclusion: The ethical challenges that impacted on obtaining informed consent in the RHDGen study were complex. In this study, the main challenges were diagnostic misconception among RHDGen controls and therapeutic misconception among RHDGen cases.
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    Informed consent for peripheral nerve blocks at a tertiary level hospital in South Africa: a quality improvement project
    (2025) Burger, Roxanne; Gibbs, Matthew; Plenge, Ulla
    Background: In South Africa, the doctrine of informed consent (introduced by the South African courts, Cape Provincial Division) dictates that all reasonable patients be told of material risks and alternative options before consenting to medical treatment or procedural interventions. The reasonable patient standard requires that a patient be told of all material risks that would influence a reasonable person in determining whether or not to consent to the treatment. Regional anaesthesia, including peripheral nerve blocks (PNBs), provides a plethora of benefits to patients undergoing surgery but, due to potential risks involved, also requires informed consent. Studies have shown that South African anaesthetists do not regularly obtain adequate informed consent for these procedures. We implemented a quality improvement project to facilitate and enhance documented informed consent in our setting. Methods: A prospective quality improvement project was established at Groote Schuur Hospital, Cape Town, including all PNBs performed in two-week blocks before and after the introduction of a standardised regional anaesthesia informed consent form. The primary outcome, comparing the incidence of documented informed consent between the two groups, was assessed with the McNemar paired-sample test for differences in proportions. Regression analysis was used to explore the effect of prespecified confounders (such as documented consent taken, benefits discussed, alternatives discussed, complications discussed and whether autonomy was documented). Results: In total, 39 and 43 patients were included in the pre- and post-intervention groups, respectively. In our setting, anaesthetists were 4.16 times (95% confidence interval (CI) -6.67 to -2.98, p < 0.001) more likely to take documented informed consent when provided with a standardised form. The incidence of documented informed consent improved from 7.7% to 60.5%. Regression analysis showed that these confounders influenced the recall of the PNB consent and discussed benefits and complications. Overall, recall was mostly influenced when benefits were discussed with patients (95%CI -20.023 to -14.64, p < 0.001). Conclusion: Documentation of informed consent for PNBs in our setting is poor. A standardised consent form can facilitate the documentation of consent significantly. Patient recollection of the consent process also improved, specifically when benefits were discussed.