Dataset Information

Pre-post implementation survey of a multicomponent intervention to improve informed consent for caesarean section in Southern Malawi.

ABSTRACT:

Objective

Surgical informed consent is essential prior to caesarean section, but potentially compromised by insufficient communication. We assessed the association between a multicomponent intervention and women's recollection of information pertaining to informed consent for caesarean section in a low-resource setting, thereby contributing to respectful maternity care.

Design

Pre-post implementation survey, conducted from January to June 2018, surveying women prior to discharge.

Setting

Rural 150-bed mission hospital in Southern Malawi.

Participants

A total of 160 postoperative women were included: 80 preimplementation and 80 postimplementation.

Intervention

Based on observed deficiencies and input from local stakeholders, a multicomponent intervention was developed, consisting of a standardised checklist, wall poster with a six-step guide and on-the-job communication training for health workers.

Primary and secondary outcome measures

Individual components of informed consent were: indication, explanation of procedure, common complications, implications for future pregnancies and verbal enquiry of consent, which were compared preintervention and postintervention using ?² test. Generalised linear models were used to analyse incompleteness scores and recollection of the informed consent process.

Results

The proportion of women who recollected being informed about procedure-related risks increased from 25/80 to 47/80 (OR 3.13 (95% CI 1.64 to 6.00)). Recollection of an explanation of the procedure changed from 44/80 to 55/80 (OR 1.80 (0.94 to 3.44)), implications for future pregnancy from 25/80 to 47/80 (1.69 (0.89 to 3.20)) and of consent enquiry from 67/80 to 73/80 (OR 2.02 (0.73 to 5.37)). After controlling for other variables, incompleteness scores postintervention were 26% lower (Exp(?)=0.74; 95% CI 0.57 to 0.96). Recollection of common complications increased with 0.25 complications (?=0.25; 95% CI 0.01 to 0.49). Recollection of the correct indication did not differ significantly.

Conclusion

Recollection of informed consent for caesarean section changed significantly in the postintervention group. Obtaining informed consent for caesarean section is one of the essential components of respectful maternity care.

SUBMITTER: Zethof S

PROVIDER: S-EPMC6955547 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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Publications

Pre-post implementation survey of a multicomponent intervention to improve informed consent for caesarean section in Southern Malawi.

Zethof Siem S Bakker Wouter W Nansongole Felix F Kilowe Kelvin K van Roosmalen Jos J van den Akker Thomas T

BMJ open 20200106 1

<h4>Objective</h4>Surgical informed consent is essential prior to caesarean section, but potentially compromised by insufficient communication. We assessed the association between a multicomponent intervention and women's recollection of information pertaining to informed consent for caesarean section in a low-resource setting, thereby contributing to respectful maternity care.<h4>Design</h4>Pre-post implementation survey, conducted from January to June 2018, surveying women prior to discharge.< ...[more]

PMID: 31911511

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Project description:BackgroundCaesarean section (CS) is not recommended for PMTCT in Malawi HIV Guidelines, contrary to most high-income countries where CS is indicated if viral suppression is sub-optimal pre-delivery. We describe patterns of CS in HIV-infected and uninfected women in Malawi and explored if insight into the use of Elective CS (ECS) for PMTCT could be obtained.MethodsWe used routinely collected data from individual medical records from 17 large health facilities in the central and southern regions of Malawi, from January 2010 to December 2013. We included data from maternity registers from all HIV-positive women, and randomly selected around every fourth woman with negative or unknown HIV status. We used multivariable logistic regressions and cluster-based robust standard errors to examine independent associations of patient- and facility characteristics with CS and ECS.ResultsWe included 62,033 women in the analysis. The weighted percentage of women who had a spontaneous vaginal delivery was 80.0% (CI 95% 79.5-80.4%); 2.4% (95% CI 2.3-2.6%) had a vacuum extraction; 2.3% (95% CI 2.2-2.5%) had a vaginal breech delivery; 14.0% (95% CI 13.6-14.4%) had a CS while for 1.3% (95% CI 1.2-1.4%) the mode of delivery was not recorded. Prevalence of CS without recorded medical or obstetric indication (ECS) was 5.1%, (n = 3152). Presence of maternal and infant complications and older age were independently associated with CS delivery. HIV-positive women were less likely to have ECS than HIV negative women (aOR 0.65; 95%-CI 0.57-0.74). Among HIV-positive women, those on antiretrovirals (ARV's) for ≥4 weeks prior to delivery were less likely to have ECS than HIV-positive women who had not received ARVs during pregnancy (aOR 0.81; 95% CI 0.68-0.96).ConclusionsThe pattern of CS's in Malawi is largely determined by maternal and infant complications. Positive HIV status was negatively associated with CS delivery, possibly because health care workers were concerned about the risk of occupational HIV transmission and the known increased risk of post-operative complications. Our results leave open the possibility that CS is practiced to prevent MTCT given that ECS was more common among women at high risk of MTCT due to no or short exposure to ARV's.

Project description:IntroductionEarly phase cancer clinical trials have become increasingly complicated in terms of patient selection and trial procedures-this is reflected in the increasing length of participant information sheets (PIS). Informed consent for early phase clinical trials has been contentious due to the potential ethical issues associated with performing experimental research on a terminally ill population which has exhausted standard treatment options. Empirical studies have demonstrated significant gaps in patient understanding regarding the nature and intent of these trials. This study aims to test whether enhanced informed consent for patient education can improve patient scores on a validated questionnaire testing clinical trial comprehension.Methods and analysisThis is a randomised controlled trial that will allocate patients who are eligible to participate in one of four investigator-initiated clinical trials at the Royal Marsden Drug Development Unit to either a standard arm or an experimental arm, stratified by age and educational level. The standard arm will involve the full length trial PIS, followed by electronic or paper administration of the Quality of Informed Consent Questionnaire Parts A and B (QuIC-A and QuIC-B). The experimental arm will involve the full length trial PIS, exposure to a two-page study aid and 10 online educational videos, followed by administration of the QuIC-A and QuIC-B. The primary endpoint will be the difference (using a one-sided two-sample t-test) in the QuIC-A score, which measures objective understanding, between the standard and experimental arm. Accrual target is at least 17 patients per arm to detect an 8 point difference (80% power, alpha 0.05).Ethics and disseminationEthics approval was granted by the National Health Service Health Research Authority on 15 June 2020-IRAS Project ID 277065, Protocol Number CCR5165, REC Reference 20/EE/0155. Results will be disseminated via publication in a relevant journal.Trial registration numberNCT04407676; Pre-results.

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Project description:BackgroundInformed consent is one of the key elements in biomedical research. The introduction of electronic informed consent can be a way to overcome many challenges related to paper-based informed consent; however, its novel opportunities remain largely unfulfilled due to several barriers.ObjectiveWe aimed to provide an overview of the ethical, legal, regulatory, and user interface perspectives of multiple stakeholder groups in order to assist responsible implementation of electronic informed consent in biomedical research.MethodsWe conducted a systematic literature search using Web of Science (Core collection), PubMed, EMBASE, ACM Digital Library, and PsycARTICLES. PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines were used for reporting this work. We included empirical full-text studies focusing on the concept of electronic informed consent in biomedical research covering the ethical, legal, regulatory, and user interface domains. Studies written in English and published from January 2010 onward were selected. We explored perspectives of different stakeholder groups, in particular researchers, research participants, health authorities, and ethics committees. We critically appraised literature included in the systematic review using the Newcastle-Ottawa scale for cohort and cross-sectional studies, Critical Appraisal Skills Programme for qualitative studies, Mixed Methods Appraisal Tool for mixed methods studies, and Jadad tool for randomized controlled trials.ResultsA total of 40 studies met our inclusion criteria. Overall, the studies were heterogeneous in the type of study design, population, intervention, research context, and the tools used. Most of the studies' populations were research participants (ie, patients and healthy volunteers). The majority of studies addressed barriers to achieving adequate understanding when using electronic informed consent. Concerns shared by multiple stakeholder groups were related to the security and legal validity of an electronic informed consent platform and usability for specific groups of research participants.ConclusionsElectronic informed consent has the potential to improve the informed consent process in biomedical research compared to the current paper-based consent. The ethical, legal, regulatory, and user interface perspectives outlined in this review might serve to enhance the future implementation of electronic informed consent.Trial registrationPROSPERO International Prospective Register of Systematic Reviews CRD42020158979; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=158979.

Dataset Information

Pre-post implementation survey of a multicomponent intervention to improve informed consent for caesarean section in Southern Malawi.

Objective

Design

Setting

Participants

Intervention

Primary and secondary outcome measures

Results

Conclusion

Publications

Pre-post implementation survey of a multicomponent intervention to improve informed consent for caesarean section in Southern Malawi.

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