Information bias of vaccine effectiveness estimation due to informed consent for national registration of COVID-19 vaccination
C.H. (Henri) van Werkhoven, Brechje de Gier, Scott McDonald, Hester E. de Melker, Susan J.M. Hahné, Susan van den Hof, Mirjam J. Knol
medRxiv, 20 February 2024
Abstract
Background
Registration in the Dutch national COVID-19 vaccination register requires consent from the vaccinee. This causes misclassification of non-consenting vaccinated persons as being unvaccinated. We quantified and corrected the resulting information bias in the estimation of vaccine effectiveness (VE).
Methods
National data were used for the period dominated by the SARS-CoV-2 Delta variant (11 July to 15 November 2021). VE ((1-relative risk)*100 %) against COVID-19 hospitalization and ICU admission was estimated for individuals 12-49, 50-69, and ≥70 years of age using negative binomial regression. Anonymous data on vaccinations administered by the Municipal Health Services were used to determine informed consent percentages and estimate corrected VEs by iteratively imputing corrected vaccination status. Absolute bias was calculated as the absolute change in VE; relative bias as uncorrected / corrected relative risk.
Results
A total of 8,804 COVID-19 hospitalizations and 1,692 COVID-19 ICU admissions were observed. The bias was largest in the 70+ age group where the non-consent proportion was 7.0% and observed vaccination coverage was 87%: VE of primary vaccination against hospitalization changed from 75.5% (95% CI 73.5-77.4) before to 85.9% (95% CI 84.7-87.1) after correction (absolute bias -10.4 percentage point, relative bias 1.74). VE against ICU admission in this group was 88.7% (95% CI 86.2-90.8) before and 93.7% (95% CI 92.2-94.9) after correction (absolute bias -5.0 percentage point, relative bias 1.79).
Conclusions
VE estimates can be substantially biased with modest non-consent percentages for registration of vaccination. Data on covariate specific non-consent percentages should be available to correct this bias.

Practices and attitudes of herbalists regarding informed consent in Uganda: A qualitative study
Sumayiya Nalubega, Paul Kutyabami, Adeline Twimukye, David. K. Mafigiri, Nelson. K. Sewankambo
Research Square, 8 February 2024
Abstract
Background
Informed consent (IC) is a fundamental principle in medical ethics that upholds respect for patient autonomy. Although widely applied in healthcare, its feasibility and implementation in herbal medicine have been underexplored. This study therefore aimed to explore the practices and attitudes of herbalists regarding informed consent.
Methods
To achieve these objectives, a qualitative cross-sectional study was conducted from June to December 2020. Twenty-one in-depth interviews with herbalists and four key informant interviews with leaders of the different traditional medicine organizations were also conducted. The data were analyzed thematically using NVivo version 12 software.
Results
Sixteen of the twenty-one participants acquired oral herbal medicine knowledge from their relatives. Although a positive inclination toward obtaining IC was evident, the focus was on disclosing basic information. Discussions of alternative treatments and herbal specifics less frequent. Disease management decisions often involve shared responsibility within families or societies. Documented IC procedures are rare among herbalists, who deem consent forms unnecessary, although they recognize the potential benefits of IC in fostering trust and professionalism. Challenges hindering IC implementation included regulatory gaps, inadequate skills, and the absence of mechanisms to protect the intellectual property rights of herbal medicine.
Conclusion
This study illuminates how educational, cultural, familial, and regulatory factors influence herbalists’ practices and attitudes toward informed consent.

Consent in Canadian-Led Critical Care Research During the COVID-19 Pandemic: A Scoping Review
Karla Krewulak, Lisa Albrecht, Saoirse Cameron, Jessica Gibson, Dori-Ann Martin, Rebecca Porteous, Margaret Sampson, Katie O’Hearn
medRxiv, 3 February 2024
Abstract
Introduction
Despite the importance of critical care research during the SARS-CoV-2 pandemic, several pandemic-related factors made the process of obtaining prior written informed consent for research infeasible. To overcome these challenges, research studies utilized alternate informed consent models suggested by available guidance.
Objective
To describe the consent models used in Canadian intensive care unit (ICU) and pediatric ICU (PICU) studies during the COVID-19 pandemic.
Data Sources
We searched MEDLINE, EMBASE, CENTRAL, clinicaltrials.gov, and medRxiv from 01-Jan2020 to 28-Apr-2023 using Medical Subject Headings and keywords related to the setting (ICU, PICU), study design (e.g., RCT) and study region (i.e., Canada). We included Canadian-led studies that were enrolling during the SARS-CoV-2 and reported on consent. Two independent reviewers reviewed titles/abstracts and full text articles for inclusion.
Results
We included 13 studies from adult (n=12, 92.3%) and pediatric (n=1, 7.7%) populations. Some study authors reported that informed (n=3/13, 23.1%) or a priori (n=2/13, 15.4%) consent was obtained, without further details. Study authors also reported using written informed (n=4/13, 30.8%), deferred (n=3/13, 23.1%), verbal/waived/assent (each n=2/13, 15.4%), or that ethics approval was not necessary which means consent was not required (n=1/13, 7.7%). Five studies (n=5/13, 38.5%) used multiple consent models: a priori/deferred (n=2/5, 40%), written/verbal (n=2/5, 40%), or waived/assent (n=1/5, 20%).
Conclusion
This scoping review underscores the importance of transparent reporting of or modifications to trial procedures during crises, such as the COVID-19 pandemic. Improved reporting practices and exploration of alternate consent models, including electronic consent, are crucial for advancing critical care trials beyond the pandemic and preparing for future health emergencies.

Use of abbreviations in consent forms for orthopaedic patients: A quality improvement project
Khan MN, Anjum S, Shafique H
Authorea Preprints, 30 January 2024
Abstract
Consent is a process of communication and the consent form is an important legal document of the evidence of discussion between doctor and patients. We observed frequent use of abbreviations in the consent forms in our department that can result in misunderstanding and miscommunication when consenting patients for orthopaedic procedures. We completed an audit cycle starting by reviewing a total of 350 consent forms retrospectively in level one trauma centres in October-November of 2019 for different orthopaedic trauma procedures. The standards for the project were guidelines published by the general medical council (GMC), The royal college of surgeons (RCS) Glasgow, and the British orthopaedic association (BOA). The results were presented at our mortality and morbidity meeting. Written Feedback was obtained from the attending members on how a change can be implemented to increase ccompliance in filling consent forms. A generic email was sent to all medical professionals to avoid the use of abbreviations on the document and encourage colleagues to point out errors if they spot them. The use of full medical terms and to avoid abbreviations in consent form was well advertised, The re-audit was performed for the period of January & February 2020 that included 400 consent forms. The results were analysed and compared with our original audit results. The use of abbreviations declined from 54% in first audit to 22% in the re-audit. DVT and PE were the most common abbreviations. This audit cycle has shown the importance of education and reminders to the health professionals in achieving better adherence to the guidelines and improves patient care.

Experiences Of Patients Undergoing Emergency Surgery And Next Of Kin On Decision Making During The Informed Consent Process In Two Tertiary Teaching Hospitals Of A Low-Income African Country: A Qualitative Study
Olivia Kituuka, Erisa Mwaka, Ian Munabi, Nelson Sewankambo, Moses Galukande
Advance, 29 January 2024
Abstract
Background
In emergency situations, patients and their next of kin must make complex medical and ethical decisions in a quick and timely way.
Methods
In-depth interviews were conducted among 22 patients and 17 next of kin of patients who had undergone emergency surgery within 24 -72hrs at two tertiary teaching hospitals. Responses about decision-making were coded into four themes; decision makers, people consulted, documentation of the consent, and factors influencing decision making.
Results
Most patients and next of kin made decisions on their own and personally documented the consent for themselves or their patient for the next of kin. Other family members and doctors were consulted during the decision-making process. Decision making was influenced by assurance of good outcomes of surgery and disclosure by the doctors.
Conclusion
Decisions were made collaboratively with the patient at the centre but with input from health personnel, the next of kin, and other family members.

Editor’s note: Advance is a preprint server in the Sage community.