A systematic review and narrative synthesis of the research provisions under the Mental Capacity Act (2005) in England and Wales: Recruitment of adults with capacity and communication difficulties.

BACKGROUND: The Mental Capacity Act (MCA, 2005) and its accompanying Code of Practice (2007), govern research participation for adults with capacity and communication difficulties in England and Wales. We conducted a systematic review and narrative synthesis to investigate the application of these provisions from 2007 to 2019. METHODS AND FINDINGS: We included studies with mental capacity in their criteria, involving participants aged 16 years and above, with capacity-affecting conditions and conducted in England and Wales after the implementation of the MCA. Clinical trials of medicines were excluded. We searched seven databases: Academic Search Complete, ASSIA, MEDLINE, CINAHL, PsycArticles, PsycINFO and Science Direct. We used narrative synthesis to report our results. Our review follows Preferred Reporting Items for Systematic Reviews and is registered on PROSPERO, CRD42020195652. 28 studies of various research designs met our eligibility criteria: 14 (50.0%) were quantitative, 12 (42.9%) qualitative and 2 (7.1%) mixed methods. Included participants were adults with intellectual disabilities (n = 12), dementia (n = 9), mental health disorders (n = 2), autism (n = 3) and aphasia after stroke (n = 2). We found no studies involving adults with acquired brain injury. Diverse strategies were used in the recruitment of adults with capacity and communication difficulties with seven studies excluding individuals deemed to lack capacity. CONCLUSIONS: We found relatively few studies including adults with capacity and communication difficulties with existing regulations interpreted variably. Limited use of consultees and exclusions on the basis of capacity and communication difficulties indicate that this group continue to be under-represented in research. If health and social interventions are to be effective for this population, they need to be included in primary research. The use of strategic adaptations and accommodations during the recruitment process, may serve to support their inclusion.

"It is what I tell her that she will do": a mixed methods study of married men's knowledge and attitude towards supporting their wives' cervical cancer screening in rural South-East Nigeria.

INTRODUCTION: cervical cancer is a leading cause of death among Nigerian women. Women often require spousal support before attending cervical cancer screening services. This study assessed married men´s knowledge and attitude towards male involvement in cervical cancer screening of their wives. METHODS: a cross-sectional study using a mixed methods approach was conducted among 245 married men in Izzi, Local Government Area of Ebonyi State, South-East Nigeria. Quantitative data collected using structured, interviewer-administered questionnaires and qualitative data from focus group discussions were triangulated. Data analysis was done using IBM SPSS version 20. Qualitative findings were analysed using thematic analysis. RESULTS: the mean knowledge of cervical cancer was 2.06±0.55. Only 2.9% of the respondents had adequate knowledge of risk factors for cervical cancer. Up to 89.8% were willing to approve screening for their spouses. Majority (76.3%) considered screening important in cervical cancer prevention, while 91.4% were willing to pay for the screening test. Most of them exhibited patriarchal tendencies and insisted that their wives must obtain their consent before screening as depicted by the statement "It is what I tell her that she will do". Previous spousal screening was a predictor of good knowledge (OR = 10.94, 95% CI = 2.44-48.93; P=0.002). CONCLUSION: married men in this study had poor knowledge of cervical cancer. However, they were willing to support cervical cancer screening conditional on their pre-information and consent. Awareness creation activities on cervical cancer screening should incorporate active engagement of husbands in order to promote screening uptake by their wives.

Bundled Consent in US Intensive Care Units.

BACKGROUND: Bundled consent, the practice of obtaining anticipatory consent for a predefined set of intensive care unit procedures, increases the rate of informed consent conversations and incorporation of patients' wishes into medical decision-making without sacrificing patients' or surrogates' understanding. However, the adoption rate for this practice in academic and nonacademic centers in the United States is unknown. OBJECTIVE: To determine the national prevalence of use of bundled consent in adult intensive care units and opinions related to bundled consent. METHODS: A random sample of US hospitals with medical/surgical intensive care units was selected from the AHA [American Hospital Association] Guide. One intensive care unit provider (bedside nurse, nurse manager, or physician) from each hospital was asked to self-reportuse of per-procedure consent versus bundled consent, consent rate for intensive care unit procedures, and opinions about bundled consent. RESULTS: Of the 238 hospitals contacted, respondents from 100 (42%) completed the survey; 94% of respondents were nurses. The prevalence of bundled consent use was 15% (95% CI, 9%-24%). Respondents using per-procedure consent were more likely than those using bundled consent to self-report performing invasive procedures without consent. Users of bundled consent unanimously recommended the practice, and 49% of respondents using per-procedure consent reported interest in implementing bundled consent. RESULTS: Bundled consent use is uncommon in academic and nonacademic intensive care units, most likely because of conflicting evidence about the effect on patients and surrogate decision makers. Future work is needed to determine if patients, family members, and providers prefer bundled consent over per-procedure consent.

Factors associated with organ donation by trauma patients in Nova Scotia.

BACKGROUND: Trauma patients represent a significant pool of potential organ donors (PODs), and previous research suggests that this population is underutilized for organ donation (OD). Our objective was to assess factors associated with OD in the trauma population. METHODS: We retrospectively analyzed OD in Nova Scotia over a 7-year period (2009-2016) using data from the Nova Scotia Trauma Registry and Nova Scotia Legacy of Life Donor Registry. All trauma patients who died in the hospital were included. Multiple logistic regression was used to assess factors associated with donation. We also evaluated characteristics, donation types, and reasons for nondonation among trauma PODs. RESULTS: There were 689 trauma-related deaths in all hospitals in NS during the study period, of which 39.8% (274 of 689) met the Nova Scotia Trauma Registry definition of a POD. Data on OD were available for 108 of these patients who were referred to the Legacy of Life Program. The conversion rate was 84%. Compared with nondonors, organ donors were significantly younger, had a higher Abbreviated Injury Scale head score and a lower scene Glasgow Coma Scale score, were more likely to suffer ischemia from drowning or asphyxia and to require air transport, and were less likely to have comorbidities. Regression analysis showed that donation was associated with younger age (odds ratio [OR], 0.97; 95% confidence interval [CI], 0.95-0.99) and lower Glasgow Coma Scale score at the scene (OR, 0.76; 95% CI, 0.66-0.88). Odds of donation were increased with air transport compared with land ambulance (OR, 8.27; 95% CI, 2.07-33.08) and injury within Halifax Regional Municipality compared with injury outside Halifax Regional Municipality (OR, 4.64; 95% CI, 1.42-15.10). Among the 60 referred PODs who did not donate, family refusal of consent was the most common reason (28 [46.7%] of 60). CONCLUSION: Younger age, greater severity of injury, and shorter time to tertiary care were associated with OD in trauma patients. LEVEL OF EVIDENCE: Prognostic and Epidemiological, Level III.

Electroconvulsive Therapy in Incapable Patients Refusing Treatment: Prevalence, Effectiveness, and Associated Factors.

OBJECTIVES: Severe psychiatric disorders may be accompanied by life-threatening conditions, lack of insight, and treatment refusal. Involuntary treatment may be indicated in patients who lack capacity to consent and refuse treatment. In this context, there is a lack of systematic data regarding the use of electroconvulsive therapy (ECT) in Germany. METHODS: A questionnaire with 25 items comprising quantitative and qualitative data was sent to all psychiatric hospitals in Germany that perform ECT. Cases of ECT treatment in incapable patients refusing therapy were identified retrospectively in a 12-month period. RESULTS: Fifty-three hospitals completed the questionnaire, and 15 cases of ECT in incapable and refusing patients were reported. A marked clinical response was observed in 14 patients. Capacity to consent was restored in 11 patients. In contrast to this particularly good effectiveness, psychiatrists' attitudes revealed a widespread lack of experience as well as reservations and uncertainties regarding the use of ECT against the patient's wishes. CONCLUSIONS: In line with other recent publications, our data suggest a very good benefit-to-risk ratio for ECT in incapable patients refusing the treatment, while at the same time the provision of ECT in such patients is rare in Germany. In light of the scarcity of treatment alternatives and the possible consequences of a refusal to perform ECT in life-threatening conditions, a general rejection of involuntary ECT does not seem ethically appropriate.

A positive deviance approach to improve familial authorization for organ donation.

The current study evaluates the Positive Deviance Donation Collaborative, a communication training program designed to identify and disseminate behaviors of requesters with above-average rates of familial authorization to organ donation. The program initiated with a cohort of 99 requesters from 11 OPOs. Requesters' quarterly authorization rates were monitored for 33 months, and their pre-/post-intervention skills in active-empathic listening and self-efficacy to request donation were assessed. Overall, requesters' mean quarterly authorization rate was 53.69% (SD = 4.54). Multilevel models were used to examine change in authorization rates and communication skills, as well as associations between skills and authorization. Low intraclass correlation coefficients for authorization rates established that most variance was due to within-requester variation, rather than OPOs (ρ = 0.0129) or requesters within OPOs (ρ = 0.0221). Models indicated that authorization rates and communication skills failed to improve following intervention and did not identify an association between post-intervention communication skills and authorization. Results provide a framework to discuss programmatic challenges including extensive requester turnover (ie, ~60%), management of data collection across multi-site interventions, and program content.

Bereaved relatives' decision about deceased organ donation: An integrated psycho-social study conducted in Spain.

RATIONALE: Family refusal to organ donation of a deceased relative represents one of the most important barriers to organ transplantation. Although a large literature about family decisions has amassed, the existing evidence needs further integration and structuring. OBJECTIVE: This study seeks to analyse relationships between bereaved relatives' decisions and a wide range of factors that converge in the family decision process, including interactions and complex relationship patterns, and taking psychosocial theoretical frameworks as reference to conceptualize empirical findings. METHOD: This observational study examined 16 Spanish hospitals during a 36-month period. Transplant coordination teams collected data of 421 cases of family decision processes about donation (338 donations/83 refusals) through a previously validated instrument. Indicators of the following factors were collected: deceased's characteristics; circumstances of death; bereaved relatives' characteristics, beliefs, and expressions; behaviour of health and coordination staff; and family's emotional responses. Three global hypotheses related to bivariate and multivariate relations of factors with family decisions and relationships/interactions among factors were tested. RESULTS: Relatives' beliefs about the deceased's wishes concerning donation are the strongest predictor of family decisions. However, family decisions are also related to the deceased's characteristics, relatives' characteristics, satisfaction with medical attention, satisfaction with personal treatment and relatives' emotional responses, and other factors. Relatives' emotional reactions are related to satisfaction with health-staff interventions and condition family decision, even if deceased's will concerning donation is known and positive. Relatives' beliefs about deceased's wishes concerning donation vary as a function of deceased's characteristics and according to relatives' characteristics. CONCLUSIONS: Understanding of family decisions underlying organ donation may greatly benefit from a more complex, integrated, and theoretically based approach. Educational efforts should stress the need to register or simply communicate own willingness to donate organs. However, an adequate training and performance of the health-staff involved in the organ donation process may generate substantive differences in consent rates.

Going it Alone: A Scoping Review of Unbefriended Older Adults.

Older adults who have reduced decision-making capacity and no family or friends to compensate for these deficiencies are known as unbefriended and require a public guardian. The purpose of this study was to review the peer-reviewed and grey literature to determine the scope of available research on unbefriended older adults in Canada and the United States. We found limited research examining unbefriended older adults. No Canadian studies or reports were located. Unbefriended older adults were childless or had fewer children, were more cognitively impaired, and were older than older adults who were not unbefriended. These findings demonstrate a stark scarcity of studies on unbefriended older adults. Research is urgently needed using standardized data collection of guardianship status in order to enable studies of the prevalence of public guardianship in Canada.

Advance care planning for haemodialysis patients.

BACKGROUND: End-stage kidney disease (ESKD) is a chronic, debilitative and progressive illness that may need interventions such as dialysis, transplantation, dietary and fluid restrictions. Most patients with ESKD will require renal replacement therapy, such as kidney transplantation or maintenance dialysis. Advance care planning traditionally encompass instructions via living wills, and concern patient preferences about interventions such as cardiopulmonary resuscitation and feeding tubes, or circumstances around assigning surrogate decision makers. Most people undergoing haemodialysis are not aware of advance care planning and few patients formalise their wishes as advance directives and of those who do, many do not discuss their decisions with a physician. Advance care planning involves planning for future healthcare decisions and preferences of the patient in advance while comprehension is intact. It is an essential part of good palliative care that likely improves the lives and deaths of haemodialysis patients. OBJECTIVES: The objective of this review was to determine whether advance care planning in haemodialysis patients, compared with no or less structured forms of advance care planning, can result in fewer hospital admissions or less use of treatments with life-prolonging or curative intent, and if patient's wishes were followed at end-of-life. SEARCH METHODS: We searched the Cochrane Kidney and Transplant Specialised Register to 27 June 2016 through contact with the Information Specialist using search terms relevant to this review. We also searched the Cumulative Index of Nursing and Allied Health Literature (CINAHL), and Social Work Abstracts (OvidSP). SELECTION CRITERIA: All randomised controlled trials (RCTs) and quasi-RCTs (RCTs in which allocation to treatment was obtained by alternation, use of alternate medical records, date of birth or other predictable methods) looking at advance care planning versus no form of advance care planning in haemodialysis patients was considered for inclusion without language restriction. DATA COLLECTION AND ANALYSIS: Data extraction was carried out independently by two authors using standard data extraction forms. Studies reported in non-English language journals were translated before assessment. Where more than one publication of one study exists, reports were grouped together and the publication with the most complete data was used in the analyses. Where relevant outcomes are only published in earlier versions these data were used. Any discrepancies between published versions were highlighted. Non-randomised controlled studies were excluded. MAIN RESULTS: We included two studies (three reports) that involved 337 participants which investigated advance care planning for people with ESKD. Neither of the included studies reported outcomes relevant to this review. Study quality was assessed as suboptimal. AUTHORS' CONCLUSIONS: We found sparse data that were assessed at suboptimal quality and therefore we were unable to formulate conclusions about whether advance care planning can influence numbers of hospital admissions and treatment required by people with ESKD, or if patients' advance care directives were followed at end-of-life. Further well designed and adequately powered RCTs are needed to better inform patient and clinical decision-making about advance care planning and advance directives among people with ESKD who are undergoing dialysis.

Guardianship and End-of-Life Decision Making.

As the population ages, more adults will develop impaired decision-making capacity and have no family members or friends available to make medical decisions on their behalf. In such situations, a professional guardian is often appointed by the court. This official has no preexisting relationship with the impaired individual but is paid to serve as a surrogate decision maker. When a professional guardian is faced with decisions concerning life-sustaining treatment, substituted judgment may be impossible, and reports have repeatedly suggested that guardians are reluctant to make the decision to limit care. Physicians are well positioned to assist guardians with these decisions and safeguard the rights of the vulnerable persons they represent. Doing so effectively requires knowledge of the laws governing end-of-life decisions by guardians. However, physicians are often uncertain about whether guardians are empowered to withhold treatment and when their decisions require judicial review. To address this issue, we analyzed state guardianship statutes and reviewed recent legal cases to characterize the authority of a guardian over choices about end-of-life treatment. We found that most state guardianship statutes have no language about end-of-life decisions. We identified 5 legal cases during the past decade that addressed a guardian's authority over these decisions, and only 1 case provided a broad framework applicable to clinical practice. Work to improve end-of-life decision making by guardians may benefit from a multidisciplinary effort to develop comprehensive standards to guide clinicians and guardians when treatment decisions need to be made.

The association of health status and providing consent to continued participation in an out-of-hospital cardiac arrest trial performed under exception from informed consent.

OBJECTIVES: Emergency medical research performed under federal regulation 21 § CFR 50.24 provides a means to protect human subjects and investigate novel time-sensitive treatments. Although prospective individual consent is not required for studies conducted under this regulation, consent from a legally authorized representative (LAR) or the patient at the earliest feasible opportunity is required to obtain short- and long-term outcome data. The objective of this study was to determine which demographic, cardiac arrest, and patient outcome characteristics predicted the likelihood of obtaining informed consent following enrollment under exception from informed consent in a multicenter cardiac arrest study. METHODS: This investigation was an analysis of data collected during a multisite, randomized, controlled, out-of-hospital cardiac arrest clinical trial performed under 21 § CFR 50.24. Research personnel attempted to obtain informed consent from LARs and subjects for medical records review of primary outcome data, as well as consent for neurologic outcome assessments up to 1 year post-cardiac arrest. Hospital discharge and neurologic status were obtained from public records and/or medical records up until the time consent was formally denied, in accordance with federal regulations and guidance. Local institutional review boards also allowed medical records review for cases where consent was neither obtained nor declined despite multiple consent attempts. Patient demographic, cardiac arrest, and clinical outcome characteristics were analyzed in univariate multinomial regression models, with consent status (obtained, denied, neither obtained nor denied) as the dependent variable. A multivariate multinomial logistic regression was then performed. An exploratory secondary analysis following the same process was performed after assigning patients who neither consented nor declined to the declined consent group. RESULTS: Among a total study population of 1,655 cardiac arrest subjects, 457 were transported and had consent attempted (27.6%). The survival status and neurologic function at the time of hospital discharge were known in 440 of 457 (96%) subjects. In the multivariate analysis, initial rhythm of ventricular fibrillation/ventricular tachycardia (VF/VT) and survival with good neurologic outcome were strong predictors of obtaining consent (odds ratio [OR] = 3.15, 95% confidence interval [CI] = 1.73 to 5.75; OR = 7.64, 95% CI = 2.28 to 25.63, respectively). The exploratory secondary analysis also showed initial rhythm of VF/VT and survival with good neurologic outcome as strong predictors of obtaining consent (OR = 1.86, 95% CI = 1.17 to 2.95; OR = 4.52, 95% CI = 2.21 to 9.26, respectively). CONCLUSIONS: Initial arrest rhythm and survival with good neurologic outcome were highly predictive of obtaining consent in this cardiac arrest trial. This phenomenon could result in underrepresentation of outcome data in the study arm with the worse outcome and represents a significant potential confounder in studies performed under 21 § CFR 50.24. Future revisions to the exception from informed consent regulations should allow access to critical survival data recorded as part of standard documentation, regardless of patient consent status.

Comparative analysis of family consent to tissue donation according to two different donation form structures.

OBJECTIVE: To define donors' profile of an Organ and Tissue Procurement Center and compare the family consent for tissue donation before and after modification of the Donation Term. METHODS: A descriptive, documentary and quantitative study performed in an Organ and Tissue Procurement Center, analyzed 111 feasible donors' charts in the period from March 13 to September 13, 2010 (1st period), and from September 14, 2010 to March 14, 2011 (2nd period), based on the modification date. RESULTS: The mean age of donors was 45.2 years, being 52.3% female. The causes of death included cerebral vascular accident (stroke) (64%), head trauma (27%), anoxic encephalopathy (2.7%), firearm injuries (2.7%) and others (3.6%). The notifications were predominantly of spontaneous origin (91%). Comparing the periods before and after the modification of the Donation Term, the donation consent for cornea increased by 17.2% and the consent for skin, bones, tendons and muscles had a discreet increase by 3.1%, 9.9% and 0.4%, respectively. On the other hand, there was decrease in consent for blood vessel (0.8%) and heart valves (4.1%) between the two periods. CONCLUSION: There was increase in family consent for donation of most tissues, but it was statistically significant only for cornea donation.

Voluntary participation and comprehension of informed consent in a genetic epidemiological study of breast cancer in Nigeria.

BACKGROUND: Studies on informed consent to medical research conducted in low or middle-income settings have increased, including empirical investigations of consent to genetic research. We investigated voluntary participation and comprehension of informed consent among women involved in a genetic epidemiological study on breast cancer in an urban setting of Nigeria comparing women in the case and control groups. METHODS: Surveys were administered in face-to-face interviews with 215 participants following their enrollment in the genetic study (106 patients, 109 controls). Audio-taped in-depth interviews were conducted with a sub-sample of 17 (8%) women who completed the survey. RESULTS: The majority of all participants reported being told that participation in the genetic study was voluntary (97%), that they did not feel pressured to participate in the study (99%), and that they could withdraw from the study (81%). The majority of the breast cancer patients (83%) compared to 58% of women in the control group reported that the study purpose was to learn about the genetic inheritance of breast cancer (OR 3.44; 95% CI =1.66, 7.14, p value = 0.001). Most participants reported being told about study procedures (95%) and study benefits (98%). Sixty-eight percent of the patients, compared to 47% of the control group reported being told about study risks (p-value <0.001). Of the 165 married women, 19% reported asking permission from their husbands to enroll in the breast cancer study; no one sought permission from local elders. In-depth interviews highlight the use of persuasion and negotiation between a wife and her husband regarding study participation. CONCLUSIONS: The global expansion of genetic and genomic research highlights our need to understand informed consent practices for studies in ethnically diverse cultural environments such as Africa. Quantitative and qualitative empirical investigations of the informed consent process for genetic and genomic research will further our knowledge of complex issues associated with communication of information, comprehension, decisional authority and voluntary participation. In the future, the development and testing of innovative strategies to promote voluntary participation and comprehension of the goals of genomic research will contribute to our understanding of strategies that enhance the consent process.

Comparative analysis of family consent to tissue donation according to two different donation form structures / Análise comparativa do consentimento familiar para doação de tecidos em função da mudança estrutural do termo de doação

Objective To define donors’ profile of an Organ and Tissue Procurement Center and compare the family consent for tissue donation before and after modification of the Donation Term. Methods A descriptive, documentary and quantitative study performed in an Organ and Tissue Procurement Center, analyzed 111 feasible donors’ charts in the period from March 13 to September 13, 2010 (1st period), and from September 14, 2010 to March 14, 2011 (2nd period), based on the modification date. Results The mean age of donors was 45.2 years, being 52.3% female. The causes of death included cerebral vascular accident (stroke) (64%), head trauma (27%), anoxic encephalopathy (2.7%), firearm injuries (2.7%) and others (3.6%). The notifications were predominantly of spontaneous origin (91%). Comparing the periods before and after the modification of the Donation Term, the donation consent for cornea increased by 17.2% and the consent for skin, bones, tendons and muscles had a discreet increase by 3.1%, 9.9% and 0.4%, respectively. On the other hand, there was decrease in consent for blood vessel (0.8%) and heart valves (4.1%) between the two periods. Conclusion There was increase in family consent for donation of most tissues, but it was statistically significant only for cornea donation. .

Objetivo Traçar o perfil dos doadores viabilizados por um Serviço de Procura de Órgãos e Tecidos e comparar o consentimento familiar para doação de tecidos antes e após esta modificação do Termo de Doação. Método Estudo descritivo, documental, quantitativo, realizado em um Serviço de Procura de Órgãos e Tecidos, analisou 111 prontuários de doadores viabilizados nos períodos de 13 de março a 13 de setembro de 2010 (1o Período) e de 14 de Setembro de 2010 a 14 de Março de 2011 (2o período), selecionados com base na data desta modificação. Resultado Foi encontrada média de idade de 45,2 anos entre os doadores, sendo 52,3% do sexo feminino. As causas de morte incluem acidente vascular encefálico (64%), traumatismos cranioencefálicos (27%), encefalopatias anóxicas (2,7%), ferimentos por arma de fogo (2,7%) e outras (3,6%). As notificações foram predominantemente de origem espontânea (91%). Comparando os períodos antes e após a modificação do Termo de Doação, o consentimento para doação de córneas apresentou aumento de 17,2% e para doação de pele, ossos, tendões e músculos, discreto aumento de 3,1%, 9,9% e 0,4% respectivamente. Por sua vez, apresentou discreta diminuição o consentimento de vasos sanguíneos, de 0,8%, e valvas cardíacas de 4,1%, entre os períodos. Conclusão Obteve-se um aumento do consentimento familiar para a doação da maioria dos tecidos, porém com significância estatística apenas para doação de córneas. .

Substitute consent practices in the face of uncertainty: a survey of Canadian researchers in aging.

BACKGROUND: In Canada and elsewhere, research policies require researchers to secure consent from a legally authorized representative (LAR) for prospective participants unable to consent. Few jurisdictions, however, offer a clear legislative basis for LAR identification. We investigated Canadian researchers' practices regarding the involvement of decisionally incapacitated participants and tested whether reported practices were associated with (1) researchers' understanding of the law on third-party authorization of research and (2) their comfort with allowing a family member to consent on behalf of an incapacitated relative. METHODS: We surveyed researchers in aging from four Canadian provinces about their practices with prospective participants deemed incapable of consent, their understanding of relevant law, and comfort with family consent for research purposes. Understanding and comfort were measured with research vignettes that briefly described hypothetical studies in which an adult who lacks the capacity to consent was invited to participate. RESULTS: Many respondents reported soliciting consent from a family member (45.7% for low-risk studies and 10.7% for serious risks studies), even in jurisdictions where such authority is uncertain at law. Researchers' tendency to solicit family consent was associated with their comfort in doing so, but not with their understanding of the law on substitute consent for research. CONCLUSIONS: Findings underscore the need to clarify who may authorize an incapacitated adult's participation in research. Meanwhile, people should inform their relatives of their desire to participate or not in research in the event of incapacity, given researchers' tendency to turn to family for consent, even where not supported by law.

Providing social support in a persuasive context: forms of social support reported by organ procurement coordinators.

Eighty-five organ procurement coordinators (OPCs) completed face-to-face interviews designed to elicit the emotional and instrumental social support strategies communicated to potential donor families throughout the request for deceased organ donation. OPCs identified six forms of emotional support and eight forms of instrumental support, with greater reported use of instrumental support strategies. In terms of instrumental support, OPCs most frequently ensured in-hospital comfort (61.2%) or met the nutritional needs of family members (51.8%). With respect to emotional support, OPCs most often expressed sympathy (31.8%) to families and provided support in the form of physical contact (27.1%) with family members. Identifying the forms of social support used by OPCs is a first step toward understanding the strategies that are more (or less) effective in achieving persuasive and support goals.

Obtaining surrogate consent for a minimal-risk research study in the intensive care unit setting.

BACKGROUND: Obtaining surrogate consent for clinical research studies conducted in the intensive care unit (ICU) setting is logistically challenging. PURPOSE: To determine whether differences in proportions consenting to trial enrollment existed among patients eligible to consent directly versus those requiring surrogate decision makers in a minimal-risk study to evaluate the accuracy of continuous glucose monitoring in the ICU setting. METHODS: Low initial enrollment rates prompted a detailed tracking of the screening and consent process. We analyzed the subset of eligible patients identified during a single year to document whether they were approached about trial enrollment, whether they consented or declined, the reasons for declining, and the method of consent (self or surrogate). The proportion of participants who consented and the reasons for declining were compared for self-consenting and surrogate-consenting participants. RESULTS: Of the 3041 patients screened, one-third (n = 982) were eligible; 119 of the 982 were approached regarding enrollment. Absence of a surrogate accounted for the majority of eligible patients (726; 84%) not approached. The most common reasons for refusal in the self versus surrogate groups included feeling overwhelmed (13% vs 24%), fear of discomfort (22% vs 12%), and fear of risk (7% vs 4%). Of the 57 eligible patients capable of consenting directly, 11 (19%) enrolled versus 12 (19%) of the 62 who required surrogate consent. When recruitment hours were expanded to include evening time, more eligible patients or their surrogates could be approached than during the day-shift hours alone. Consent was obtained for a larger proportion of potential participants with a history of diabetes (40%) than for those without a history of diabetes (14%). LIMITATIONS: The findings are from a subset of the entire study sample; data were available only for participants who could be approached, who may have differed from those who could not be approached. CONCLUSIONS: Surrogate and self-consent rates were similar. Surrogate unavailability was a major barrier to enrollment; overlap of staffing with usual visiting hours should be considered when planning trials in the ICU.

Consent for organ donation.

Improving the consent rate for solid organ donation from deceased donors is a key component of strategies in the UK and other countries to increase the availability of organs for transplantation. In the UK, the law is currently clear on what forms consent may take, with the views of the individual expressed previously in life taking priority. Such views may have been expressed prospectively, via membership of the Organ Donor Register or by talking to family members. The factors determining such actions include both positive altruistic motives and negative psychological responses. Studies have examined why some families of potential donors refuse consent, while others have demonstrated a key set of 'modifiable' factors relating to the family approach. These include ensuring the right timing of a request in an appropriate setting, providing emotional support, and imparting specific information, particularly concerning the nature of brain death. If these are optimized and the right personnel with adequate training are involved in a planned process, then consent rates may be improved as reported in other countries with organized donation systems.

Remarkable changes in the choice of timing to discuss organ donation with the relatives of a patient: a study in 228 organ donations in 20 years.

INTRODUCTION: We studied whether the choice of timing of discussing organ donation for the first time with the relatives of a patient with catastrophic brain injury in The Netherlands has changed over time and explored its possible consequences. Second, we investigated how thorough the process of brain death determination was over time by studying the number of medical specialists involved. And we studied the possible influence of the Donor Register on the consent rate. METHODS: We performed a retrospective chart review of all effectuated brain dead organ donors between 1987 and 2009 in one Dutch university hospital with a large neurosurgical serving area. RESULTS: A total of 271 medical charts were collected, of which 228 brain dead patients were included. In the first period, organ donation was discussed for the first time after brain death determination (87%). In 13% of the cases, the issue of organ donation was raised before the first EEG. After 1998, we observed a shift in this practice. Discussing organ donation for the first time after brain death determination occurred in only 18% of the cases. In 58% of the cases, the issue of organ donation was discussed before the first EEG but after confirming the absence of all brain stem reflexes, and in 24% of the cases, the issue of organ donation was discussed after the prognosis was deemed catastrophic but before a neurologist or neurosurgeon assessed and determined the absence of all brain stem reflexes as required by the Dutch brain death determination protocol. CONCLUSIONS: The phases in the process of brain death determination and the time at which organ donation is first discussed with relatives have changed over time. Possible causes of this change are the introduction of the Donor Register, the reintroduction of donation after circulatory death and other logistical factors. It is unclear whether the observed shift contributed to the high refusal rate in The Netherlands and the increase in family refusal in our hospital in the second studied period. Taking published literature on this subject into account, it is possible that this may have a counterproductive effect.