Capacity to consent to research among adolescent-parent dyads in Rakai, Uganda
Philip Kreniske, Susie Hoffman, William Ddaaki, Neema Nakyanjo, Esther Spindler, Charles Ssekyewa, Dauda Isabirye, Rosette Nakubulwa, Nabakka Proscovia, Lee Daniel, Nao Haba, Mahlet Maru, Julia Thompson, Ivy S. Chen, Fred Nalugoda, Robert Ssekubugu, Tom Lutalo, Mary A. Ott, John S. Santelli
The Journal of Pediatrics, 17 November 2022
Abstract
Objectives
To assess the cognitive capacity of early, middle, and late adolescents, and their parents or guardians to provide informed consent to a population-based cohort study.
Study design
Adolescent-parent/guardian dyads including 40 early (N = 80; 10-14 years), 20 middle (15-17 years), and 20 late (18-19 years) adolescents were recruited from the Rakai Community Cohort Study (RCCS), an open demographic cohort in Uganda. Participants were administered the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR), a structured open-ended assessment; interviews were recorded and transcribed. Twenty transcripts were scored independently by two coders; the intraclass correlation coefficient (ICC) was 0.89. The remaining interviews were scored individually. We compared mean scores for early and middle/late adolescents using a one-sided t-test and score differences between parent/guardian and adolescent dyads using two-sided paired t-tests.
Results
Early adolescents (mean score, 95% confidence interval (CI)) (28.8, 27.1-30.5) scored significantly lower (p<.01) than middle/late adolescents (32.4, 31.6-33.1). In paired dyad comparisons, we observed no statistically significant difference in scores between parents/guardians and middle/late adolescents (difference=-0.2, 95% CI=-1.0-0.6). We found a statistically significant difference in scores between parents/guardians and early adolescents (difference=3.0, 95% CI=1.2-4.8).
Conclusions
The capacity of adolescents of different ages and in diverse settings to comprehend risks, benefits, and other elements of informed consent is a critical but understudied area in research ethics. Our findings support the practice of having middle and late adolescents provide independent informed consent for sexual and reproductive health studies. Early adolescents may benefit from supported decision-making approaches.
Status of medical information and patient consent in orthopedic surgery and traumatology at the University Hospital of Burgos (period 2017-2018)
Status of medical information and patient consent in orthopedic surgery and traumatology at the University Hospital of Burgos (period 2017-2018)
Original Article
Jacobo Salvat Dávila, Juan Salvat Puig, Jesús María Gonçalves Estella, Secundino Vicente González
Spanish Journal of Legal Medicine, 17 November 2022
Abstract
Introduction
The principle of autonomy is the basis of the informed consent concept. Informed consent is a patient´s right consisting in prior to the medical intervention being carried out on his body, he must express his agreement that it must be preceded by the proper information that allows him to decide according to his interests. In this work, our objective was to know the status of medical information and informed consent of the patient in the Traumatology and Orthopedic Surgery Service of the University Hospital of Burgos.
Material and methods
An anonymous questionnaire was prepared and distributed among 647 orthopedic surgery and trauma patients at the University Hospital of Burgos. Subsequently, a descriptive, cross-sectional, observational quantitative study was carried out. The association of sociodemographic variables with the responses to the questionnaire items was studied.
Results
Only 28.9% of the patients know that information is a right, but the majority (97.3%) expressed the need to receive information on risks and complications of the treatment and consider that the information does not increase fear or anxiety (63.4%). The majority stated that they were informed about the care performance (98.1%), understanding the explanations received (98.0%). The time used was sufficient (73.7%). In general, the information received was rated as sufficient (89.8).
Conclusions
Most of the patients felt informed and considered that the time that the doctor had had for this was sufficient.
A qualitative exploration of obtaining informed consent in medical consultations with Burma-born women
A qualitative exploration of obtaining informed consent in medical consultations with Burma-born women
Anna Power, Amita Tuteja, Lester Mascarenhas, Meredith Temple-Smith
Australian Journal of Primary Health, 7 November 2022
Abstract
Background
Conciliatory attitudes, respect for medical professionals and avoidance of being direct can make health consultations with Burma-born patients difficult to navigate. Coupled with linguistic barriers, this may make the sensitive nature of many women’s health consultations challenging. Little is known about current practices for obtaining informed consent in this context. The objectives of this study were to explore current practices, barriers and strategies to obtaining informed consent in medical consultations with women born in Burma.
Methods
Purposive and snowball sampling was used to recruit health practitioners (n=15, 2 male, 13 female) of different ages, years of professional experience, and country of origin, from clinics in Victoria that see a high volume of Burma-born patients. Thirty to sixty minute semi-structured interviews were conducted with 4 general practitioners, 8 nurses and 3 interpreters, and deidentified audio recordings were transcribed for inductive thematic analysis.
Results
Five key themes were generated (i) cultural cognisance; (ii) influence of community (iii) skilful navigation of communication; (iv) favourable consultation attributes; and (v) individual tailoring of consent conversations. Differing cultural expectations, and linguistic and educational barriers, were highlighted as challenges to obtaining informed consent, while thoughtful utilisation of non-verbal communication, and intentional customisation of consent conversations were identified as facilitators.
Conclusion
The findings of this study provide practical ways to optimise the informed consent process within the Australian primary healthcare context, and reinforce that accepted Western-based practices for obtaining informed consent are not a ‘one-size-fits-all’.
Patient satisfaction with surgical informed consent at Jimma Medical Center, Ethiopia
Patient satisfaction with surgical informed consent at Jimma Medical Center, Ethiopia
Research article
Tsegaw Biyazin, Ayanos Taye & Yeshitila Belay
BMC Medical Ethics, 25 October 2022; 23(103)
Open Access
Abstract
Background
Informed consent is a process in which a healthcare provider obtains permission from an individual prior to surgery. Patient satisfaction with the informed consent process is one of the main indicators of healthcare service quality. This study aimed to assess patient satisfaction with surgical informed consent at Jimma Medical Center, Ethiopia, in 2020.
Methods
A facility-based cross-sectional study was conducted from April 1 to June 30, 2020, at Jimma Medical Center. Face-to-face interviews were conducted using structured questionnaires. A systematic sampling technique was used to select the study participants. The collected data were coded, entered into Epi data version 3.1, and analyzed using SPSS version 25. Bivariate and multivariate regression analyses were performed to determine the association between patient satisfaction and socio-demographic and facility-related factors. In multivariate regression, predictors with a P-value of < 0.05 were considered statistically significant.
Results
Totally 372 study participants were interviewed with a response rate of 97.8%. Nearly two-fifths (43%) of patients were satisfied with surgical informed consent. Living in an urban area (AOR: 2.279, 95% CI 1.257–4.131), having current referred history (AOR: 1.856, 95% CI 1.033–3.337), consent form version (AOR: 2.076, 95% CI 1.143–3.773), time spent on the provision of informed consent (AOR: 5.227, 95% CI 2.499–10.936) and having better patient-health providers relationship (AOR: 5.419, 95% CI 3.103–9.464) predictors were positively associated with patient satisfaction.
Conclusion
Patient satisfaction with the surgical informed consent process was relatively low. Therefore, Health care professionals need to emphasize a way of delivering informed consent, patients’ needs and obey a standard informed consent to improve patient satisfaction.
Making Removals Part of Informed Choice: A Mixed-Method Study of Client Experiences With Removal of Long-Acting Reversible Contraceptives in Senegal
Making Removals Part of Informed Choice: A Mixed-Method Study of Client Experiences With Removal of Long-Acting Reversible Contraceptives in Senegal
Aurélie Brunie, Fatou Ndiaté Rachel Sarr Aw, Salif Ndiaye, Etienne Dioh, Elena Lebetkin, Megan M. Lydon, Elizabeth Knippler, Sarah Brittingham, Marème Dabo, Marème Mady Dia Ndiaye
Global Health: Science and Practice, October 2022; 10(5)
Open Access
Abstract
Background
Ensuring access to removal services for implants and intrauterine devices (IUDs) is essential to realize informed choice and voluntary family planning. We document removal desires and experiences among women who received an implant or IUD from the public sector in 3 districts of Senegal.
Methods
We conducted a phone survey of 1,868 implant and IUD users, 598 follow-up surveys with those who had ever asked a provider for a removal, and 24 in-depth interviews (IDIs) with women who had ever wanted an implant removal. We analyzed survey data descriptively and IDI data thematically.
Results
Fifty-eight percent of implant users and 54% of IUD users reported having wanted a removal. Desired pregnancy and contraceptive-induced menstrual changes (CIMCs) were the main reasons for removal desires. Fifty-four percent of implant users and 55% of IUD users who asked a provider for a removal reported challenges accessing services, with over two-thirds noting long lines or wait times. Sixty-three percent of implant users and 73% of IUD users who saw a provider were satisfied with the outcome of their first interaction. Over 90% of participants had not been told about the removal cost at insertion. Almost all participants who had their method removed obtained a complete removal during their first clinical procedure. Around two-thirds of participants who obtained a removal did not take up another method at that time. IDIs confirmed the influence of CIMCs on removal desires and show some partner influence is common in removal decision making. Barriers include lack of available qualified providers and supplies. Provider interactions play an important role in satisfaction with removal services.
Conclusion
Participants’ experiences accessing removal services were generally positive. Areas of potential improvement include client flow, counseling messages at insertion, and when advising clients to keep their method, pricing, and post-removal reinsertion or method switching.
The effects of modifying elements of written informed consent forms for elective surgical or invasive procedures: A systematic review
The effects of modifying elements of written informed consent forms for elective surgical or invasive procedures: A systematic review
Stefanie Bühn, Elen Huppertz, Alina Weise, Julia Lühnen, Anke Steckelberg, Roland Brian Büchter, Simone Hess, Kyung-Eun (Anna) Choi, Tim Mathes
Patient Education and Counseling, February 2023; 107
Abstract
Objective
To study the effect of modifying content and design elements within written informed-consent-forms (ICF) for patients undergoing elective surgical or invasive procedures.
Methods
We included (quasi-)randomized trials in which a modified written ICF (e.g. visual aids) was compared to a standard written ICF. We searched PubMed, Web-of-Science and PsycINFO until 08/2021. Risk of Bias was assessed. The complexity of intervention was assessed using the Intervention Complexity Assessment Tool for Systematic Reviews.
Results
Eleven trials with 1091 participants were eligible. Effect sizes and levels of evidence varied from trivial to moderate and there were contradictory findings for some outcomes. Providing patients with more information in general or specific information on risks and complications mostly increased anxiety. The use of verbal risk presentation decreased anxiety and increased satisfaction. A lower readability level decreased anxiety and improved comprehension and knowledge.
Conclusion
Our results suggest that providing more information and addressing certain types of risks have differential effects. While more information improved knowledge, it also increased anxiety. We did not find any or only insufficient evidence for many other possible ICF modifications.
Practice implications
When developing ICFs the differential impact of different elements on patient important outcomes should be carefully considered.
An evaluation of the efficacy of a supplemental computer-based tutorial to enhance the informed consent process for cataract surgery: an exploratory randomized clinical study
An evaluation of the efficacy of a supplemental computer-based tutorial to enhance the informed consent process for cataract surgery: an exploratory randomized clinical study
Research
Marlies Ullrich, Oliver Findl, Katharina Kefer, Birgit Döller, Ralph Varsits, Julius Hienert, Nino Hirnschall
BMC Ophthalmology, 11 November 2022; 22(430)
Open Access
Abstract
Background
To assess whether informing patients with a computer-based tutorial in addition to standard informed consent influences the patient’s attitude towards surgery and increases patient’s knowledge.
Methods
In this prospective, exploratory, randomized clinical study, patients scheduled for their first eye cataract surgery were randomly allocated to two groups, receiving standard face-to-face informed consent (control group) or additionally using an interactive computer-based tool (CatInfo) containing an audiovisual presentation about cataract and its treatment (study group). Cataract-related knowledge and decisional confidence (decisional conflict scale (DCS)) were assessed as well as one-month postoperatively decisional regret (decision regret scale (DRS)) and willingness to exchange face-to-face discussion time for the use of such a tool.
Results
The study comprised 134 patients, 64 patients in the study group and 70 in the control group. Patients in the study group answered more questions correctly, 16.3 ± 2.0 (median 16.5, 11.0–19.0) versus 15.5 ± 1.9 (median 16.0, 8.0–19.0; p = 0.01). Patients showed a high decisional confidence with a study group mean DCS score of 92.4 ± 9.8 (median 96.9, 65.6–100) and control group score of 91.6 ± 10.9 (median 95.3, 43.3–100; p = 0.52). Mean DRS score in the study group was 2.5 ± 8.0 (median 0, 0–40) and 4.3 ± 12.5 (median 0, 0–75) in the control group (p = 0.14). Of study group patients 23 (67.6%) were willing to trade time, on average 158 ± 180 s (median 120 s, 45–900). Satisfaction with the tool was high with a mean of 9.1 ± 1.3 out of 10 (median 9.7, 5.0–10).
Conclusions
Cataract-related knowledge was generally good, with slightly higher scores in the study group. In both groups, decisional confidence was high and regret after surgery was low. A tendency towards slightly higher decisional confidence and lower regret was found in the study group, although these differences were not statistically significant. Additional use of an interactive computer-based tool may prove useful in the informed consent process in a high-volume cataract outpatient setting.
The role of knowledge and medical involvement in the context of informed consent: a course or a blessing?
The role of knowledge and medical involvement in the context of informed consent: a course or a blessing?
Caterina Milo
Medicine, Health Care and Philosophy, 1 November 2022
Open Access
Abstract
Informed consent (IC) is a key patients’ right. It gives patients the opportunity to access relevant information/knowledge and to support their decision-making role in partnership with clinicians. Despite this promising account of IC, the relationship between ‘knowledge’, as derived from IC, and the role of clinicians is often misunderstood. I offer two examples of this: (1) the prenatal testing and screening for disabilities; (2) the consent process in the abortion context. In the first example, IC is often over-medicalized, that is to say the disclosure of information appears to be strongly in the clinicians’ hands. In this context, knowledge has often been a curse on prospective parents. Framing information in a doctor-centred and often negative way has hindered upon prospective parents’ decision-making role and also portrayed wrong assumptions upon disabled people more widely. In the second context, information is more often than not dismissed and, in a de-medicalized scenario, medical contribution often underplayed. The latter leads to an understanding of the dialogue with clinicians as a mere hinderance to the timely access to an abortion. Ultimately, I claim that it is important that knowledge, as derived from IC, is neither altogether dismissed via a process of de-medicalization, nor used as a curse on patients via a process of over-medicalization. None of the two gives justice to IC. Only when a better balance between medical and patients’ contribution is sought, knowledge can aspire to be a blessing (i.e. an opportunity for them), not a curse on patients in the IC context.
The “teach-back” method improves surgical informed consent and shared decision-making: a proof of concept study
The “teach-back” method improves surgical informed consent and shared decision-making: a proof of concept study
Research
Kevin D. Seely, Jordan A. Higgs, Lindsey Butts, Jason M. Roe, Colton B. Merrill, Isain Zapata, Andrew Nigh
Patient Safety in Surgery, 28 October 2022; 16(33)
Open Access
Abstract
Introduction
The teach-back method is a communication tool that can improve patient safety and shared decision-making. Its utility in patient care has been studied extensively in many areas of clinical medicine. However, the literature on teach-back in surgical patient education and informed consent is limited, and few studies have been conducted to test its impact on perioperative patient interactions. The objective of this study was to evaluate if the teach-back method can improve informed consent and surgeon trust. An assessment of the time required to be implemented was also evaluated.
Methods
A standardized interaction role-playing a pre-operative informed consent discussion was designed. Laparoscopic cholecystectomy was selected as the proposed procedure. Standardized patients were split into two groups: teach-back and a control group. The control group was delivered a script that discloses the risks and benefits of laparoscopic cholecystectomy followed by a concluding prompt for any questions. The teach-back group was presented the same script followed by the teach-back method. Interactions were timed and patients completed a quiz assessing their knowledge of the risks and benefits and a survey assessing subjective perceptions about the interaction. Statistical analysis through Generalized Linear Models (GLMs) was used to compare visit length, performance on the comprehension quiz, and subjective surgeon trust perceptions.
Results
34 participants completed the scenario, the comprehension quiz, and the survey (n = 34). Analysis of the subjective evaluation of the physician and encounter was significant for increased physician trust (p = 0.0457). The intervention group performed higher on the knowledge check by an average of one point when compared to the control group (p = 0.0479). The visits with intervention took an average of 2.45 min longer than the control group visits (p = 0.0014). People who had the actual procedure in the past (evaluated as a confounder) were not significantly more likely to display the same effect as the teach-back method, suggesting that the knowledge and trust gained were not based on previous experiences with the procedure.
Conclusion
When employed correctly by surgeons in the perioperative setting, the teach-back method enhances shared decision-making, comprehension, and surgeon trust. Incorporating the teach-back method into risk and benefit disclosures effectively informs and more fully engages patients in the informed consent process. Notably, the added benefits from using teach-back can be obtained without a burdensome increase in the length of visit.
Explanation before Adoption: Revealing Methods Used to Support Informed Consent for Complex Platforms
Explanation before Adoption: Revealing Methods Used to Support Informed Consent for Complex Platforms
Rachel Eardley, Emma L. Tonkin, Ewan Soubutts, Amid Ayobi, Gregory J. L. Tourte, Rachael Gooberman-Hill, Ian J Craddock, Aisling Ann O’Kane
Proceedings of the ACM on Human-Computer Interaction [Bristol, UK], April 2023
Abstract
Explaining health technology platforms to non-technical members of the public is an important part of the process of informed consent. Complex technology platforms that deal with safety-critical areas are particularly challenging, often operating within private domains (eg health services within the home) and used by individuals with various understandings of hardware, software, and algorithmic design. Through two studies, the first an interview and the second an observational study, we questioned how experts (eg those who designed, built, and installed a technology platform) supported provision of informed consent by participants. We identify a wide range of tools, techniques, and adaptations used by experts to explain the complex SPHERE sensor-based home health platform, provide implications for the design of tools to aid explanations, suggest opportunities for interactive explanations, present the range of information needed, and indicate future research possibilities in communicating technology platforms.
Center for Informed Consent Integrity 