Prevalence of different variations of non-consented care during the childbirth process in Mexico by geographical regions: comparing ENDIREH survey data from 2016 to 2021.

INTRODUCTION: Non-consented care, a form of obstetric violence involving the lack of informed consent for procedures, is a common but little-understood phenomenon in the global public health arena. The aim of this secondary analysis was to measure the prevalence and assess change over time of non-consented care during childbirth in Mexico in 2016 and 2021, as well as to examine the association of sociodemographic, pregnancy-, and childbirth-factors with this type of violence. METHODS: We measured the prevalence of non-consented care and three of its variations, forced sterilization or contraception, forced cesarean section, and forced consent on paperwork, during childbirth in Mexico for 2016 (N = 24,036) and 2021 (N = 19,322) using data from Mexico's cross-sectional National Survey on the Dynamics of Household Relationships (ENDIREH). Weighted data were stratified by geographical regions. We performed adjusted logistic regression analyses to explore associations. RESULTS: The national prevalence of non-consented care and one of its variations, pressure to get a contraceptive method, increased from 2016 to 2021. A decrease in the prevalence was observed for forced contraception or sterilization without knowledge, forcing women to sign paperwork, and non-consented cesarean sections nationally and in most regions. Women between the ages of 26 and 35 years, married, cohabiting with partner, living in urban settings, who do not identify as Indigenous, and who received prenatal services or gave birth at the Mexican Institute of Social Security (IMSS) facilities experienced a higher prevalence of non-consented care. Being 26 years of age and older, living in a rural setting, experiencing stillbirths in the last five years, having a vaginal delivery, receiving prenatal services at IMSS, or delivering at a private facility were significantly associated with higher odds of reporting non-consented care. CONCLUSION: While a decrease in most of the variations of non-consented care was found, the overall prevalence of non-consented care and, in one of its variations, pressure to get contraceptives, increased at a national and regional level. Our findings suggest the need to enforce current laws and strengthen health systems, paying special attention to the geographical regions and populations that have experienced higher reported cases of this structural problem.

Surgical Informed Consent in Clinical Practice: Patients' Perspective Undergoing Cesarean Section at Three Teaching Hospitals in Addis Ababa, Ethiopia.

Background: Informed consent is a communication process of providing the patient/parents/guardians with relevant information regarding the diagnosis and the treatment so that they can make informed decisions. This study was to assess the practice of surgical informed consent in Addis Ababa. Methods: An institution-based cross-sectional study was undertaken in Addis Ababa in 2021. A total of 312 women who underwent cesarean section were interviewed immediately after their hospital discharge. Thirteen components of SIC were used based on international recommendations, including the Royal College of Surgeons' standards of informed consent practices for surgical procedures. Results: Almost all (100 %) of the respondents were asked to provide written consent, and 96.2 % of them signed the consent form. Most women (89.4%) received information about the indication(s). Few (18.6%) respondents were informed about the type of anesthesia to be administered while only 9 %( n= 28) of them were given an opportunity to choose the option of anesthesia. Only 44.9% of the respondents have received at least six of the 13 components of SIC suggested by the investigators. In this, the most secured data was the signature of the patient which is 96 %. The least documented element of SIC was alternative treatment. Conclusion: A majority of women who underwent both elective and emergency cesarean section did not receive comprehensive information during the Surgical Informed Consent process in the study hospitals. There is a need that patients need to be counseled during antenatal visits, specifically when patients visit near term for antenatal checkups.

Symptomatic Features and Factors Associated With Do-Not-Resuscitate Consent in Advanced Cancer Patients Admitted to Palliative Care Ward.

This study aimed to conduct a retrospective cross-sectional study to investigate the prevalence of symptoms and symptom clusters on sociodemographic and disease characteristics, as well as factors associated with Do-Not-Resuscitate (DNR) consent. Advanced cancer patients were enrolled between 2018 and 2020 with available data. Demographic and clinical data were obtained for analysis from Hospital Information System (HIS) in China. Symptom clusters were extracted by hierarchical cluster analysis. Chi-square test and multiple logistic regression were conducted to investigate the prevalence characteristics of symptoms and influencing factors of DNR consent, respectively. 798 advanced cancer patients were enrolled. The most prevalent symptoms were pain (93%), anorexia (36.5%), and sleep disorders (34.2%). High heart rate was associated with poor performance status and more symptoms. Three clusters were extracted: fatigue-related, respiratory-circulatory system, and digestive system symptom clusters. The incidence of symptoms was statistically significant in age, gender, education level, residence, BMI, performance status, distress score, ADL, and primary pain level. The DNR signature rate was 15.5%. Female, distant metastasis, in-ward rescue, and appearance of dyspnea were independent influencing factors of DNR signature.Chinese hospitalized cancer patients had more symptoms burden that were influenced by various demographic characteristics, especially pain and fatigue-related symptoms. Concerning the trajectory of vital signs is important among advanced cancer patients. The DNR signature rate was lower and our finding indicating an urgency to accurately assess the prognosis and give more palliative care education to enhance DNR rates and early signing in Chinese context.

Comparing Routine HIV and Hepatitis C Virus Screening to Estimate the Effect of Required Consent on HIV Screening Rates Among Hospitalized Patients.

OBJECTIVES: Routine screening for HIV and hepatitis C virus (HCV) among specified age cohorts is recommended. New York State requires consent before screening for HIV but not HCV. We sought to estimate the effect of the consent requirement on screening rates for HIV. METHODS: We performed a retrospective study of patients hospitalized in 2015-2016 at a tertiary care hospital in the Bronx, New York, during a period when prompts in the electronic health record facilitated screening for HIV and HCV among specified age cohorts. We compared proportions of patients eligible for screening for HIV and/or HCV who underwent screening and used generalized estimating equations and a meta-analytic weighted average to estimate an adjusted risk difference between undergoing HIV screening and undergoing HCV screening. RESULTS: Among 11 938 hospitalized patients eligible for HIV and/or HCV screening, 38.5% underwent screening for HIV and 59.1% underwent screening for HCV. The difference in screening rates persisted after adjusting for patient and admission characteristics (adjusted risk difference = 22.0%; 95% CI, 20.6%-23.4%). CONCLUSIONS: Whereas the requirement for consent was the only difference in the processes of screening for HIV compared with screening for HCV, differences in how the 2 viruses are perceived may also have contributed to the difference in screening rates. Nevertheless, our findings suggest that requiring consent continues to impede progress toward the public health goal of routine HIV screening.

Outcome measures in solid organ donor management research: a systematic review.

AIM: We systematically reviewed published outcome measures across randomised controlled trials (RCTs) of donor management interventions. METHODS: The systematic review was conducted in accordance with recommendations by the Cochrane Handbook and Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. We searched MEDLINE, Embase, CENTRAL, Web of Science, and trial databases from 1980 to February 2021 for RCTs of donor management interventions. RESULTS: Twenty-two RCTs (n=3432 donors) were included in our analysis. Fourteen RCTs (63.6%) reported a primary outcome relating to a single organ only. Eight RCTs primarily focused on aspects of donor optimisation in critical care. Thyroid hormones and methylprednisolone were the most commonly evaluated interventions (five and four studies, respectively). Only two studies, focusing on single organs (e.g. kidney), evaluated outcomes relating to other organs. The majority of studies evaluated physiological or biomarker-related outcomes. No study evaluated recipient health-related quality of life. Only one study sought consent from potential organ recipients. CONCLUSIONS: The majority of RCTs evaluating donor management interventions only assessed single-organ outcomes or effects on donor stability in critical care. There is a need for an evaluation of patient-centred recipient outcomes and standardisation and reporting of outcome measures for future donor management RCTs.

Prevalence and quality of informed consent for patients undergoing cosmetic procedures: a cross sectional study / Prevalencia y calidad del consentimiento informado de los pacientes sometidos a procedimientos estéticos: un estudio transversa / Prevalência e qualidade de consentimento informado para pacientes submetendo-se a procedimentos cosméticos: um estudo transversal

Abstract: Background: Failure of the physician to disclose potential risks and benefits associated with cosmetic procedures is one of the main causes of legal disputes over informed consent. The objective was to assess the prevalence and quality of the informed consent given by patients who undergone cosmetic procedures and its association with post-procedure adverse events. Methods: It was a cross-sectional, online, questionnaire-based study conducted during September and October 2020. Eligible adult male and female patients who were attending a governmental dermatology clinic at Al-Kharj city (Saudi Arabia) were invited to join the study. Results: A total of 246 patients were included in the study. Out of 246, 111 (45.1%) patients performed at least one cosmetic procedure before, and 89 (80.2%) of them signed an informed consent. 62 (69.7%) of them signed a consent before the procedure, 17 (19.1%) reported post-procedure adverse events, 16 (18.0%) reported dissatisfactions, and 27 (30.3%) reported either. None of the consent characteristics were significantly associated with higher prevalence of post-procedure adverse events or non-satisfactions. Conclusions: The prevalence and the quality of informed consent before cosmetic procedures are inadequate. Urgent corrections are required to protect the patient's rights and to legally protect the treating physician.

Resumen: Antecedentes: El hecho de que el médico no revele los posibles riesgos y beneficios asociados a los procedimientos estéticos es una de las principales causas de las disputas legales sobre el consentimiento informado. El objetivo fue evaluar la prevalencia y la calidad del consentimiento informado dado por los pacientes sometidos a procedimientos estéticos y su asociación con los eventos adversos posteriores al procedimiento. Métodos: Fue un estudio transversal, online, basado en un cuestionario, realizado durante septiembre y octubre de 2020. Se invitó a participar en el estudio a pacientes adultos de ambos sexos que acudían a una clínica dermatológica gubernamental en la ciudad de Al-Kharj (Arabia Saudí). Resultados: Un total de 246 pacientes fueron incluidos en el estudio. De los 246, 111 (45,1%) pacientes se habían sometido al menos a un procedimiento cosmético antes, y 89 (80,2%) de ellos firmaron un consentimiento informado. 62 (69,7%) de ellos firmaron un consentimiento antes del procedimiento, 17 (19,1%) informaron de acontecimientos adversos posteriores al procedimiento, 16 (18,0%) informaron de insatisfacciones y 27 (30,3%) informaron de cualquiera de los dos. Ninguna de las características del consentimiento se asoció significativamente con una mayor prevalencia de acontecimientos adversos posteriores al procedimiento o insatisfacciones. Conclusiones: La prevalencia y la calidad del consentimiento informado antes de los procedimientos cosméticos son inadecuadas. Se requieren correcciones urgentes para proteger los derechos del paciente y proteger legalmente al médico tratante.

Resumo: Contexto: A falha do médico em comunicar os potenciais riscos e benefícios associados a procedimentos cosméticos é uma das principais causas de disputas legais sobre consentimento informado. O objetivo foi avaliar a prevalência e qualidade do consentimento informado dado a pacientes que sofreram procedimentos cosméticos e sua associação com eventos adversos pós-procedimento. Métodos: Estudo transversal, online, baseado em questionário, realizado durante setembro e outubro de 2020. Pacientes homens e mulheres, adultos elegíveis, de uma clínica dermatológica governamental da cidade de Al-Kharj (Arábia Saudita) foram convidados a participar do estudo. Resultados: Um total de 246 pacientes foram incluídos no estudo. Dos 246, 111 (45.1%) pacientes realizaram pelo menos um procedimento cosmético anterior e 89 (80.2%) deles assinaram um consentimento informado. 62 (69.7%) deles assinaram um consentimento antes do procedimento, 17 (19.1%) relataram eventos adversos pós-procedimento, 16 (18.0%) relataram insatisfações e 27 (30.3%) relataram ambos. Nenhuma das características do consentimento foram significativamente associadas com mais alta prevalência de eventos adversos pós-procedimento ou não satisfação. Conclusões: A prevalência e a qualidade do consentimento informado antes de procedimentos cosméticos são inadequados. Correções urgentes são requeridas para proteger os direitos dos pacientes e para legalmente proteger o médico responsável.

Donor Factors Associated with Familial Consent for Organ Donation among Trauma Casualties: a 10-Year Retrospective Study.

BACKGROUND: Consent rates for organ donation remain one of the most important factors determining the number of organs available for transplantation. Trauma casualties constitute a substantial part of the deceased organ donor pool and have unique characteristics that distinguish them from the general donor population. However, this group has not been extensively studied. OBJECTIVES: To identify donor factors associated with positive familial consent for solid organ donation among trauma casualties. METHODS: This retrospective study included all trauma casualties who were admitted to the Rabin Medical Center, Beilinson hospital, during the period from January 2008 to December 2017, who were potential organ donors. Data collected included demographic features, the nature of the injury, surgical interventions, and which organs were donated. Data was collected from the Rabin Medical Center Trauma Registry. RESULTS: During the study period 24,504 trauma patients were admitted and 556 died over their hospital course. Of these 76 were potential donors, of whom 32 became actual donors and donated their organs. Two factors showed a statistically significant correlation to donation, namely female gender (P = 0.018) and Jewish religion of the deceased (P = 0.032). CONCLUSIONS: Only a small group of in hospital trauma deaths were potential solid organ donors (13.7%) and less than half of these became actual donors. Consent rates were higher when the deceased was female or Jewish.

Validation of the factors influencing family consent for organ donation in the UK.

Between 2013 and 2019, there was an increase in the consent rate for organ donation in the UK from 61% to 67%, but this remains lower than many European countries. Data on all family approaches (16,896) for donation in UK intensive care units or emergency departments between April 2014 and March 2019 were extracted from the referral records and the national potential donor audit held by NHS Blood and Transplant. Complete data were available for 15,465 approaches. Consent for donation after brain death was significantly higher than for donation after circulatory death, 70% (4260/6060) vs. 60% (5645/9405), (OR 1.58, 95%CI 1.47-1.69). Patient ethnicity, religious beliefs, sex and socio-economic status, and knowledge of a patient's donation decision were strongly associated with consent (p < 0.001). These factors should be addressed by medium- to long-term strategies to increase community interventions, encouraging family discussions regarding donation decisions and increasing registration on the organ donor register. The most readily modifiable factor was the involvement of an organ donation specialist nurse at all stages leading up to the approach and the approach itself. If no organ donation specialist nurse was present, the consent rates were significantly lower for donation after brain death (OR 0.31, 95%CI 0.23-0.42) and donation after cardiac death (OR 0.26, 95%CI 0.22-0.31) compared with if a collaborative approach was employed. Other modifiable factors that significantly improved consent rates included less than six relatives present during the formal approach; the time from intensive care unit admission to the approach (less for donation after brain death, more for donation after cardiac death); family not witnessing neurological death tests; and the relationship of the primary consenter to the patient. These modifiable factors should be taken into consideration when planning the best bespoke approach to an individual family to discuss the option of organ donation as an end-of-life care choice for the patient.

Patient Reported Experience on Consenting for Surgery - Elective Versus Emergency Patients.

INTRODUCTION: Informed consent for surgery is a medical and legal requirement, but completing these does not necessarily translate to high patient satisfaction. This patient-reported experience study aimed to examine the surgical consent process, comparing the patients' experience in elective and emergency settings. METHODS: Over a 6-mo period, postoperative patients at The Alfred Hospital Breast and Endocrine Surgical Unit were invited to participate in a survey on the surgical consent process - including perceived priorities, information provided and overall experience. Standard statistical techniques were used, with a significant P-value of < 0.05. RESULTS: A total of 412 patients were invited, with 130 (32%) responses. More patients underwent elective surgery (N= 90, 69%) than emergency surgery (N = 40, 31%). Emergency patients were more likely to sign the consent form regardless of its contents (93% versus 39%, P < 0.001) and more likely to be influenced by external pressures (63% versus 1%, P < 0.001). Elective patients were more likely to want to discuss their surgery with a senior surgeon (74% versus 23%, P < 0.001) and more likely to seek advice from external sources (83% versus 10%, P < 0.001). Both groups highly valued the opportunity to ask questions (67% versus 63%, P = 0.65). CONCLUSION: This study shows patients have a range of different priorities in preparation for surgery. Therefore, each consent process should be patient-specific, and focus on providing the patient with quality resources that inform decision-making.

From informed consent to adherence: factors influencing involvement in mass drug administration with ivermectin for malaria elimination in The Gambia.

BACKGROUND: The World Health Organization (WHO) recommends consideration of mass drug administration (MDA) for malaria control in low-endemic settings approaching elimination. However, MDA remains a controversial strategy, as multiple individual, social, and operational factors have shown to affect its acceptability at local levels. This is further complicated by inconsistent definitions of key indicators derived from individual and community involvement-coverage, adherence, and compliance-that cast doubts about the actual and potential epidemiological impact of MDA on disease control and elimination. This study aimed to identify limitations and enabling factors impacting involvement at different stages of a large cluster-randomized trial assessing the effect of combining dihydroartemisinin-piperaquine (DP) and ivermectin (IVM) in malaria transmission in The Gambia. METHODS: This social science study used a mixed-methods approach. Qualitative data were collected in intervention and control villages through ethnographic methods, including in-depth interviews (IDIs), focus group discussions (FGDs), and participant observation conducted with trial participants and decliners, community leaders, and field staff. A cross-sectional survey was conducted in the intervention villages after the first year of MDA. Both strands of the study explored malaria knowledge and opinions, social dynamics influencing decision-making, as well as perceived risks, burdens, and benefits associated with this MDA. RESULTS: 157 IDIs and 11 FGDs were conducted, and 864 respondents were included in the survey. Barriers and enabling factors to involvement were differentially influential at the various stages of the MDA. Issues of social influence, concerns regarding secondary effects of the medication, costs associated with malaria, and acceptability of the implementing organization, among other factors, differently affected the decision-making processes throughout the trial. Rather than a linear trajectory, involvement in this MDA trial was subjected to multiple revaluations from enrolment and consent to medicine intake and adherence to treatment. CONCLUSIONS: This study went beyond the individual factors often associated with coverage and adherence, and found that nuanced social dynamics greatly influence the decision-making process at all phases of the trial. These issues need to be consider for MDA implementation strategies and inform discussions about more accurate ways of reporting on critical effectiveness indicators.

Informed consent rates for neonatal randomized controlled trials in low- and lower middle-income versus high-income countries: A systematic review.

OBJECTIVE: Legal, ethical, and regulatory requirements of medical research uniformly call for informed consent. We aimed to characterize and compare consent rates for neonatal randomized controlled trials in low- and lower middle-income countries versus high-income countries, and to evaluate the influence of study characteristics on consent rates. METHODS: In this systematic review, we searched MEDLINE, EMBASE and Cochrane for randomized controlled trials of neonatal interventions in low- and lower middle-income countries or high-income countries published 01/01/2013 to 01/04/2018. Our primary outcome was consent rate, the proportion of eligible participants who consented amongst those approached, extracted from the article or email with the author. Using a generalised linear model for fractional dependent variables, we analysed the odds of consenting in low- and lower middle-income countries versus high-income countries across control types and interventions. FINDINGS: We screened 3523 articles, yielding 300 eligible randomized controlled trials with consent rates available for 135 low- and lower middle-income country trials and 65 high-income country trials. Median consent rates were higher for low- and lower middle-income countries (95.6%; interquartile range (IQR) 88.2-98.9) than high-income countries (82.7%; IQR 68.6-93.0; p<0.001). In adjusted regression analysis comparing low- and lower middle-income countries to high-income countries, the odds of consent for no placebo-drug/nutrition trials was 3.67 (95% Confidence Interval (CI) 1.87-7.19; p = 0.0002) and 6.40 (95%CI 3.32-12.34; p<0.0001) for placebo-drug/nutrition trials. CONCLUSION: Neonatal randomized controlled trials in low- and lower middle-income countries report consistently higher consent rates compared to high-income country trials. Our study is limited by the overrepresentation of India among randomized controlled trials in low- and lower middle-income countries. This study raises serious concerns about the adequacy of protections for highly vulnerable populations recruited to clinical trials in low- and lower middle-income countries.

Evaluating the Patient and Setting-Specific Factors That Influenced the Quality of Informed Consent in a Retrospective Cohort of Subtotal Cholecystectomy Patients.

Introduction: Cholecystectomy is the most frequently performed procedure in general surgery. The consent procedure for cholecystectomy needs to inform patients about the possibility of subtotal cholecystectomy (STC) as an alternative procedure used for "difficult gallbladders" as it is associated with increased postoperative morbidity. We sought to determine the quality of informed consent for patients who were scheduled for cholecystectomy but underwent STC, and evaluate whether patient or procedural factors influenced the information discussed in consenting. Materials and Methods: We classified 57 components of information necessary for a patient to give informed consent for cholecystectomy. We retrospectively reviewed the consent forms of patients scheduled for conventional cholecystecomy but instead undergoing STC between 2011 and 2017. Consent quality was measured as the percentage of components completed. Subgroup analyses were conducted to determine whether age, gender, American Society of Anesthesiologists grade, setting (elective/nonelective), operation mode (open/laparoscopic), or the responsible surgeon affected consent quality. Results: Across 174 patients, just 9 (5.2%) had been informed about the possibility of undergoing STC, whereas the overall quality of consent was 37.5%. Patient and setting-specific factors affected the completion of specific consent components. Patients were more likely to receive a patient information leaflet if they were female (relative risk [RR] 2.76; 95% confidence interval [CI] 1.09-7.00), <60 years (RR 3.32; 95% CI 1.39-7.90) or undergoing laparoscopic surgery (RR 8.04; 95% CI 2.50-25.88). Conclusion: The suboptimal quality of consent and multiple inconsistencies in the information disclosed to different patient cohorts emphasize the need for a more transparent and consistent consenting process.

Reflections on dynamic consent in biomedical research: the story so far.

Dynamic consent (DC) was originally developed in response to challenges to the informed consent process presented by participants agreeing to 'future research' in biobanking. In the past 12 years, it has been trialled in a number of different projects, and examined as a new approach for consent and to support patient engagement over time. There have been significant societal shifts during this time, namely in our reliance on digital tools and the use of social media, as well as a greater appreciation of the integral role of patients in biomedical research. This paper reflects on the development of DC to understand its importance in an age where digital health is becoming the norm and patients require greater oversight and control of how their data may be used in a range of settings. As well as looking back, it looks forwards to consider how DC could be further utilised to enhance the patient experience and address some of the inequalities caused by the digital divide in society.

A Century in Review: Medicolegal Implications of Facial Nerve Paralysis.

Importance: It is important to recognize factors that may mitigate the risk of a potential lawsuit and increase knowledge and awareness of physicians. Objective: To evaluate and characterize facial nerve paralysis litigation claims and related potential causes. Design, Setting, and Participants: These data were extracted from the two main computerized legal databases: WestLaw and LexisNexis. The data were queried on April 2, 2020. The records from 1919 to 2020 were obtained from a population-based setting. A total of 186 cases were included. Data were gathered for all alleged cases of facial nerve paralysis. Main Outcomes and Measures: There was a continuous rise in the amount of malpractice payments with the highest mean amount being in the past decade. Results: From 1919 to 2020, a total of 186 malpractice cases for facial nerve damage were identified. A total amount of $89,178,857.99 was rewarded to plaintiffs in 66 cases. The mean amount of paid malpractice claim was $1,351,194.80. Improper performance/treatment was the most common reason for alleged litigation (n = 97). This was followed by misdiagnosis/delayed diagnosis (n = 47), and failure of informed consent (n = 34). The highest number of malpractice claims with a total of 53 cases was from 1991 to 2000. The highest mean amount per payment was in the past decade (2011-2020) with a mean of $3,841,052.68. Conclusions and Relevance: Over the past century, improper performance/procedure, delayed/misdiagnosis, and failure of informed consent were the most common reasons for litigations related to facial nerve paralysis.

Resurrecting the Hospital Autopsy: Impact of an Office of Decedent Affairs on Consent Rates, Providers, and Next-of-Kin.

CONTEXT.­: Autopsy rates have decreased dramatically despite providing important clinical information to medical practices and social benefits to decedents' families. OBJECTIVE.­: To assess the impact of an institutional Office of Decedent Affairs (ODA), a direct communication link between pathology and decedents' families, on hospital autopsy consent rates, autopsy-related communication, practitioner views, and next-of-kin experiences. DESIGN.­: A before and after study involving all hospital decedents whose deaths did not fall within the jurisdiction of the medical examiner's office from 2013 to 2018. A pathology-run ODA launched in May 2016 to guide next-of-kin through the hospital death process (including autopsy-related decisions) and serve as the next-of-kin's contact for any subsequent autopsy-related communication. Critical care and hematology/oncology practitioners were assessed for their autopsy-related views and decedents' next-of-kin were assessed for their autopsy-related experiences. Autopsy consent rates for non-medical examiner hospital deaths, autopsy-related communication rates, practitioner views on the role and value of autopsy, and next-of-kin autopsy experiences and decisions factors were compared prior to and after ODA launch. RESULTS.­: Autopsy consent rates significantly increased from 13.2% to 17.3% (480 of 3647 deaths versus 544 of 3148 deaths; P < .001). There were significant increases in the rate of autopsy-related discussions and bereavement counseling provided to decedents' families. Practitioner views on the positive role of autopsy for any hospital death and those with advanced stage cancer also significantly increased. Next-of-kin indicated more consistent autopsy-related discussions with the potential benefits of autopsy discussed becoming key decision factors. CONCLUSIONS.­: An ODA improves hospital autopsy consent rates, autopsy-related communication, providers' autopsy-related views, and next-of-kins autopsy experiences.

Differences in demographics and outcomes based on method of consent for a randomised controlled trial on heat loss prevention in the delivery room.

OBJECTIVE: Informed consent is standard in research. International guidelines allow for research without prior consent in emergent situations, such as neonatal resuscitation. Research without prior consent was incorporated in the Vermont Oxford Network Heat Loss Prevention Trial. We evaluated whether significant differences in outcomes exist based on the consent method. DESIGN: Subgroup analysis of infants enrolled in a randomised controlled trial conducted from 2004 to 2010. SETTING: A multicentre trial with 38 participating centres. PARTICIPANTS: Infants born 24-27 weeks of gestation. 3048 infants assessed, 2231 excluded due to fetal congenital anomalies, failure to obtain consent or gestation less than 24 weeks. 817 randomised, 4 withdrew consent, total of 813 analysed. MAIN OUTCOME MEASURE: The difference in mortality between consent groups. RESULTS: No significant differences were found in mortality at 36 weeks (80.2%, 77.4%, p=0.492) or 6 months corrected gestational age (80.7%, 79.7%, p=0.765). Infants enrolled after informed consent were more likely to have mothers who had received antenatal steroids (95.2%, 84.0%, p<0.0001). They also had significantly higher Apgar scores at 1 (5.0, 4.4, p=0.019), 5 (7.3, 6.7, p=0.025) and 10 min (7.5, 6.3, p=0.0003). CONCLUSIONS AND RELEVANCE: Research without prior consent resulted in the inclusion of infants with different baseline characteristics than those enrolled after informed consent. There were no significant differences in mortality. Significantly higher Apgar scores in the informed consent group suggest that some of the sicker infants would have been excluded from enrolment under informed consent. Research without prior consent should be considered in neonatal resuscitation research.

Attitudes of Dilated Cardiomyopathy Patients and Investigators Toward Genomic Study Enrollment, Consent Process, and Return of Genetic Results.

Precision medicine genetics study design requires large, diverse cohorts and thoughtful use of electronic technologies. Involving patients in research design may increase enrollment and engagement, thereby enabling a means to relevant patient outcomes in clinical practice. Few data, however, illustrate attitudes of patients with dilated cardiomyopathy (DCM) and their family members toward genetic study design. This study assessed attitudes of 16 enrolled patients and their family members (P/FM), and 18 investigators or researchers (I/R) of the ongoing DCM Precision Medicine Study during a conjoint patient and investigator meeting using structured, self-administered surveys examining direct-to-participant enrollment and web-based consent, return of genetic results, and other aspects of genetic study design. Survey respondents were half women and largely identified as white. Web-based consent was supported by 93% of P/FM and 88% of I/R. Most respondents believed that return of genetic results would motivate study enrollment, but also indicated a desire to opt out. Ideal study design preferences included a 1-hour visit per year, along with the ability to complete study aspects by telephone or web and possibility of prophylactic medication. This study supports partnership of patients and clinical researchers to inform research priorities and study design to attain the promise of precision medicine for DCM.