Search

Background Scientific researchers who wish to reuse health data pertaining to individuals can obtain consent through an opt-in procedure or opt-out procedure. The choice of procedure may have consequences for the consent rate and representativeness of the study sample and the quality of the research, but these consequences are not well known. Objective This review aimed to provide insight into the consequences for the consent rate and consent bias of the study sample of opt-in procedures versus opt-out procedures for the reuse of routinely recorded health data for scientific research purposes. Methods A systematic review was performed based on searches in PubMed, Embase, CINAHL, PsycINFO, Web of Science Core Collection, and the Cochrane Library. Two reviewers independently included studies based on predefined eligibility criteria and assessed whether the statistical methods used in the reviewed literature were appropriate for describing the differences between consenters and nonconsenters. Statistical pooling was conducted, and a description of the results was provided. Results A total of 15 studies were included in this meta-analysis. Of the 15 studies, 13 (87%) implemented an opt-in procedure, 1 (7%) implemented an opt-out procedure, and 1 (7%) implemented both the procedures. The average weighted consent rate was 84% (60,800/72,418 among the studies that used an opt-in procedure and 96.8% (2384/2463) in the single study that used an opt-out procedure. In the single study that described both procedures, the consent rate was 21% in the opt-in group and 95.6% in the opt-out group. Opt-in procedures resulted in more consent bias compared with opt-out procedures. In studies with an opt-in procedure, consenting individuals were more likely to be males, had a higher level of education, higher income, and higher socioeconomic status. Conclusions Consent rates are generally lower when using an opt-in procedure compared with using an opt-out procedure. Furthermore, in studies with an opt-in procedure, participants are less representative of the study population. However, both the study populations and the way in which opt-in or opt-out procedures were organized varied widely between the studies, which makes it difficult to draw general conclusions regarding the desired balance between patient control over data and learning from health data. The reuse of routinely recorded health data for scientific research purposes may be hampered by administrative burdens and the risk of bias.

To determine the average reported consent rate for published pediatric randomized controlled trials (RCTs) and whether this rate varies by trial characteristics.A review of pediatric RCTs published in Medline in 2009, 2010, or 2015 was performed. Secondary analyses of prior trials, trials including adults, trials not requiring consent, or trials with missing or unclear consent data were excluded. Consent rate was defined as the number of patients enrolled divided by number of eligible patients where families were approached. Random effects meta-regression was conducted to determine the weighted average consent rate.Of 2347 trials identified, 1651 were excluded. An additional 418 of 696 (60%) were excluded because the consent rate was missing or unclear. The average consent rate for 278 included RCTs was 82.6% (95% CI, 80.3%-84.8%) and was higher for vaccination compared with behavioral trials and for industry-funded compared with National Institutes of Health-funded or other government-funded trials. The average consent rate was70% for 26% of included trials. Of these trials, US trials (28/77 [36.4%]) had a higher probability of a consent rate of70% than non-US studies (35/64 [21.3%]) and multinational (9/37 [24.3%]) studies. There was slight variation by funding category.Although the average consent rate for published trials was reasonably high, approximately one-quarter of trials had consent rates of70%. Consent rates reporting has improved over time, but remains suboptimal. Our findings should assist with the planning of future pediatric RCTs, although consent data from unpublished trials are also needed.

Background Aortic stiffness is an important marker of cardiovascular risk and is elevated in children and adolescents with congenital heart disease (CHD) compared with healthy children; however, in children with CHD, little is known about the interaction between aortic stiffness and physical activity—a key determinant of aortic stiffness. Methods For this cross-sectional cohort study, we recruited children and adolescents aged 9-16 years with moderate-to-complex CHD from British Columbia Children's Hospital and travelling partnership clinics across the province of British Columbia and the Yukon territory. Mean daily minutes of moderate-to-vigorous physical activity were objectively assessed using an ActiGraph accelerometer worn over the right hip during waking hours for 7 days. Aortic pulse wave velocity (cm/s) was measured using standard 2-dimensional echocardiography and Doppler ultrasound. Results Participants (n = 104, 61% male; 85% consent rate) had a mean (standard deviation) age of 12.4 (2.4) years. Daily moderate-to-vigorous physical activity was 46.7 (20.0) minutes/d, with 25% meeting guidelines of ≥ 60 minutes of moderate-to-vigorous physical activity per day. Mean (standard deviation) aortic pulse wave velocity was 490.5 (161.9) cm/s, which was not significantly different between cardiac diagnoses. Higher levels of moderate-to-vigorous physical activity were associated with lower aortic pulse wave velocity (r = −0.226, P = 0.021). Conclusion In children and adolescents with CHD, higher levels of physical activity are associated with better vascular function. Given this association, promoting physical activity should be a high priority in the care of children and adolescents with CHD.

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.

Chatbots are software applications to simulate a conversation with a person. The effectiveness of chatbots in facilitating the recruitment of study participants in research, specifically among racial and ethnic minorities, is unknown. The objective of this study is to compare a chatbot versus telephone-based recruitment in enrolling research participants from a predominantly minority patient population at an urban institution. We randomly allocated adults to receive either chatbot or telephone-based outreach regarding a study about vaccine hesitancy. The primary outcome was the proportion of participants who provided consent to participate in the study. In 935 participants, the proportion who answered contact attempts was significantly lower in the chatbot versus telephone group (absolute difference −21.8%; 95% confidence interval [CI] −27.0%, −16.5%; P

This study aimed to compare the consent rate for deceased organ donation in Israel over two time periods, namely 2004-2009 (2004/9) and 2016-July 2020 (2016/20). Donor and family data were collected from the Israel National Transplantation Center Registry and included donor characteristics, reasons for family consent and refusal, and a subjective assessment of donor coordinator-family interactions. The consent rate increased from 41.6% over the period 2004/9 to 61.8% for the period 2016/20 (P < 0.0001). A significant increase in the proportion of Jewish donors was noted (49.8% in 2004/9 vs. 67.5% in 2016/20, P < 0.0001), while no increase in the consent rate for the Muslim population was noted. Religious objections as a reason for refusal decreased significantly (37.6% vs. 27.3%; P = 0.02), while the proportion of families citing donating as the "right thing to do" increased significantly (7% vs. 26.6%; P < 0.0001). Finally, a significant increase in the proportion of very positive DC-family interactions (59% to 78.3%, P < 0.0001) was noted. In conclusion, the increased consent rate in 2016/20 was associated with changes in expressed decision-making and donor coordinator-donor family interactions. Additional interventions tailored to all different populations groups need to be developed and further investigated.

Background The last decade, there have been many initiatives worldwide to increase the number of organ donors. However, it is not clear which initiatives are most effective. The aim of this study is to provide an overview of interventions aimed at healthcare professionals in order to increase the number of organ donors. Methods We systematically searched PubMed, EMBASE, CINAHL, PsycINFO, and the Cochrane Library for English language studies published until April 24, 2019. We included studies describing interventions in hospitals aimed at healthcare professionals who are involved in the identification, referral, and care of a family of potential organ donors. After the title abstract and full-text selection, two reviewers independently assessed each study’s quality and extracted data. Results From the 18,854 records initially extracted from five databases, we included 22 studies in our review. Of these 22 studies, 14 showed statistically significant effects on identification rate, family consent rate, and/or donation rate. Interventions that positively influenced one or more of these outcomes were training of emergency personnel in organ donation, an electronic support system to identify and/or refer potential donors, a collaborative care pathway, donation request by a trained professional, and additional family support in the ICU by a trained nurse. The methodological quality of the studies was relatively low, mainly because of the study designs. Conclusions Although there is paucity of data, collaborative care pathways, training of healthcare professionals and additional support for relatives of potential donors seem to be promising interventions to increase the number of organ donors. Trial registration PROSPERO, CRD42018068185 Electronic supplementary material The online version of this article (10.1186/s13054-019-2509-3) contains supplementary material, which is available to authorized users.

We conducted a consented pilot newborn screening (NBS) for Pompe, Gaucher, Niemann–Pick A/B, Fabry, and MPS 1 to assess the suitability of these lysosomal storage disorders (LSDs) for public health mandated screening. At five participating high–birth rate, ethnically diverse New York City hospitals, recruiters discussed the study with postpartum parents and documented verbal consent. Screening on consented samples was performed using multiplexed tandem mass spectrometry. Screen-positive infants underwent confirmatory enzymology, DNA testing, and biomarker quantitation when available. Affected infants are being followed for clinical management and long-term outcome. Over 4 years, 65,605 infants participated, representing an overall consent rate of 73%. Sixty-nine infants were screen-positive. Twenty-three were confirmed true positives, all of whom were predicted to have late-onset phenotypes. Six of the 69 currently have undetermined disease status. Our results suggest that NBS for LSDs is much more likely to detect individuals at risk for late-onset disease, similar to results from other NBS programs. This work has demonstrated the feasibility of using a novel consented pilot NBS study design that can be modified to include other disorders under consideration for public health implementation as a means to gather critical evidence for evidence-based NBS practices.

In Korea, 2-4% of brain-dead organ donations are from donors

Contains fulltext : 225441.pdf (Publisher’s version ) (Open Access) BACKGROUND: One of the most important bottlenecks in the organ donation process worldwide is the high family refusal rate. AIMS AND OBJECTIVES: The main aim of this study was to examine whether family guidance by trained donation practitioners increased the family consent rate for organ donation. DESIGN: This was a prospective intervention study. METHODS: Intensive and coronary care unit nurses were trained in communication about donation (ie, trained donation practitioners) in two hospitals. The trained donation practitioners were appointed to guide the families of patients with a poor medical prognosis. When the patient became a potential donor, the trained donation practitioner was there to guide the family in making a well-considered decision about donation. We compared the family consent rate for donation with and without the guidance of a trained donation practitioner. RESULTS: The consent rate for donation with guidance by a trained donation practitioner was 58.8% (20/34), while the consent rate without guidance by a trained donation practitioner was 41.4% (41/99, P = 0.110) in those patients where the family had to decide on organ donation. CONCLUSIONS: Our data suggest that family guidance by a trained donation practitioner could benefit consent rates for organ donation. RELEVANCE TO CLINICAL PRACTICE: Trained nurses play an important role in supporting the families of patients who became potential donors to guide them through the decision-making process after organ donation request.

We know that reporting guidelines work, 8 so the logical next step would be to address the issues surrounding consent in the next revision of CONSORT in general and for pediatric trials specifically. It is up to all involved in pediatric trials—researchers, both those directly involved in trials and those producing evidence synthesis, regulatory and ethics bodies, granting organizations, patients, and journal editors—to resolve the issue of full transparency of the consenting process, to increase the accountability and quality of pediatric trials.

After significant improvement of the family consent rate to organ donation (OD) in recent years, owing to an increase in cultural activities and social awareness, a plateau has been reached. This study was performed to detect the causes for this plateau.We reviewed exact causes of family refusal after providing a list of failed potential donors from July 2015 to December 2016. The expert coordinators responsible for handling the failed cases chose the cause of refusal from the previously prepared list. The list was rechecked by contacting the nondonating families by phone. The results were compared with those obtained from a similar group of families in 2009.In an 18-month period of OD practice, 353 potential brain dead organ donors were referred to our organ procurement unit. The mean age of the cases was 42.6, and 62% were male. The main causes of brain death were cerebrovascular accident and trauma (41.2% and 32.6%, respectively). The family consent rate was 84.4%, and 55 families rejected the request for OD. The leading cause for family refusal was religious beliefs, mainly from Sunni families (43.6% vs 8.6% in 2009). Brain death denial reduced significantly from 44.4% in 2009 to 12.7% in 2015 and 2016 (P .001 for both causes). Opposite donor wishes, unstable family mood, the belief in body integrity, and expectation of a miracle were the other causes of no reportable changes.After massive social activities in the media designed to enhance social awareness regarding brain death and OD, people currently do not doubt the irreversibility of death, as in the past. However, the noticeable increase in the consent rate has made the religious cause of family refusal prominent. Therefore, this cause seems to be the next barrier to fight against, requiring a careful approach to religious leaders and societies.

Background: Fecal microbiota transplantation is a promising therapeutic alternative for refractory Clostridium difficile infection. Self-stool donation can overcome challenges with donor screening and eliminate risks of blood borne pathogen exposure. We assessed the feasibility of a fecal banking protocol. A secondary objective was to identify perceptions around fecal banking. Methods: Admitted medicine patients were screened over 15 months. Patients with gastrointestinal comorbidities or factors affecting intestinal microbiota were excluded. Participants completed a survey and could opt to bank a sample. Processing occurred during defined lab hours. Feasibility was assessed on process and resource indicators. Success was defined as 50% consent rate. Results: A total of 4,675 patients were screened; 60% were excluded, primarily because of antibiotic exposure (1,343, 48%). A total of 537 patients were surveyed, of whom 73% consented to fecal banking. The primary reason for declining was that fecal banking was considered ‘too gross’ (34%). Of 72 samples provided, 27 were successfully banked. Lack of a bowel movement was the primary reason for not banking (54%), and inadequate quantity was the top reason for rejecting a collected sample (63%). Average processing time was 58 minutes (range 22–640 min). The majority of participants reported a preference for using their own stool (82%), and 87.5% (n=64) were willing to bank again. Conclusion: A self-donor fecal banking protocol is feasible. Scalability of this process is addressed through dedicated resources for collecting and processing samples from larger cohorts. Formal evaluation of the efficacy and microbiome integrity of samples is required.

Background: A research register (Reach West) has been established to facilitate recruitment of people and patients to health-related research. We conducted a prospective feasibility study to investigate the practicality of recruiting through outpatient clinics.Methods: Patients over 18 years of age attending dental, eye or oncology outpatient clinics in an acute hospital in the West of England were provided with the opportunity to participate in Reach West. In Phase I, recruitment packs were handed to clinic attendees who could place completed consent forms in secure drop-box or return them later on-line or by post. In Phase II, recruitment packs were posted directly to patients with consent forms to be returned by post or on-line. Response rates by age, sex, postcode (for level of deprivation), and clinic type were recorded for those agreeing to participate on paper or on-line.Results: In Phase I, 2,314 of 4,500 (51.4%) of recruitment packs were handed out to clinic attendees, and 114 (5%)consented to join Reach West. In Phase II, 7,173 of 9000 packs were posted (79.7%), and 387 (5.4%) consented to participate. The overall consent rate was 6% (580), with the majority doing so on paper (87%) rather than on-line.The sample was balanced by sex, but mostly comprised people over 50 years located in less deprived postcodes.Non-staff costs for postal recruitment were lower than hand-outs in clinic (£6.84 compared with £8.05 per participant).Conclusions: Recruiting participants to the Reach West register was feasible among those with oncology, dental or eye outpatient appointments by post or with packs given out in the clinic. Response rates were similar to those achieved for other registers. Recruitment of participants can be achieved through outpatient clinics but other strategies will also be required to attract large numbers of participants and more diverse populations.Keywords: Research participation, Prospective consent, Research registers, Research database, Research governance, Data linkage

Background There has been little research to investigate whether the appearance of paper patient information leaflets (PILs) used to describe research studies to potential participants influences their decision to take part. Embedding a study within a trial (SWAT) is an efficient way of answering this type of methodological question. We included a randomised SWAT within a large cohort study, Outcome Monitoring after Cardiac Surgery (OMACS), to address this question. Methods Potential participants for the OMACS study were randomised to receive one of three PILs, which were identical in content but with varying formatting and use of colour: PIL A (enhanced format), PIL B (hybrid format) and PIL C (standard format). Consent to OMACS was the primary outcome. Consent rates using the three different PIL formats were collected and compared. Qualitative feedback on the different formats was obtained from a public and patient involvement (PPI) group. Results For the SWAT, 1517 PILs were sent to potential participants, of whom 640 (42%) consented to take part in OMACS. PIL B had the highest recruitment rate, with 45% of patients consenting to participation; 40% and 41% of patients consented to participation after receiving PILs A and C, respectively. Compared to PIL C, the consent rate was 4% higher with PIL B (45% versus 41%, 95% confidence interval (CI) -2% to + 10%, p = 0.16) and 1% lower with PIL A (40% versus 41%, 95% CI − 7% to + 5%, p = 0.72). Conclusions Consent rates were similar for all three PIL formats. PIL B is being used for the remainder of the host study and will be used to inform the design of PILs for other research studies, as it was the preferred format of the PPI group. Trial registration International Clinical Trials Registry, ISRCTN90204321. Registered on 21 January 2015.

In 2016, deceased-donor organ procurement at Wits Transplant, based at Wits Donald Gordon Medical Centre in Johannesburg, South Africa (SA), was in a state of crisis. As it is the largest-volume solid-organ transplant unit in SA, and as we aspire to provide transplant services of an international standard, the time to address our procurement practice had come. The number of deceased donors consented through our centre was very low, and we needed a radical change to improve our performance. This article describes the Wits Transplant Procurement Model - the result of our work to improve procurement at our centre. The model has two core phases, one to increase referrals and the other to improve our consent rates. Within these phases there are several initiatives. To improve referrals, the threefold approach of procurement management, acknowledgement and resource utilisation was developed. In order to 'convert' referrals into consents, we established the Wits Transplant 'Family Approach to Consent for Transplant Strategy' (FACTS). Since initiation of the Wits Transplant Procurement Model, both our referral numbers from targeted hospitals and our conversion rates have increased. Referrals from targeted hospitals increased by 54% (from 31 to 57). Our consent rate increased from 25% (n=6) to 73% (n=35) after the initiation of Wits Transplant FACTS. We hope that other transplant centres in SA and further afield in the region will find this article helpful, and to this end we have created a handbook on the Wits Transplant Procurement Model that is freely available for download (http://www.dgmc.co.za/docs/Wits-Transplant-Procurement-Handbook.pdf).

Background Internal pilots provide useful information which can help to optimise the running of the main trial. Although some recommendations exist in the literature for the design of internal pilots, little is known about current practice in terms of the specification and also the assessment of progression criteria. The aim of the review is to provide an overview of current practice. Methods A cohort of clinical trials with an internal pilot, funded by the National Institute for Health Research (NIHR), Health Technology Assessment programme (HTA), extracted in 2017 was reviewed. Data were extracted from: project descriptions; summary of changes from the first stage; feedback about the full application; monitoring notes; progress report history and protocols, for information about the design and assessment of internal pilots. Results Fifty-seven studies were reviewed. An internal pilot was first proposed in the early stages of the trial in the majority of cases. Target number for recruitment, rate of randomisation, retention/primary outcome ascertainment rate, rate of treatment adherence and consent rate were included as progression criteria. All but one study was permitted to continue to the main trial; however, 25% did not strictly meet the progression criteria. Changes were made to the design of the main trial for 25% of studies, mainly in terms of conduct of recruitment. Conclusions This review provides insight into the process of designing and assessing internal pilots. Progression criteria are sometimes not met; however, committees involved in the reviewing process will recommend continuation to the main trial, usually accompanied by a second review or close monitoring. Recommendations are made to optimise the process.

Numerous surveys link interview data to administrative records, conditional on respondent consent, in order to explore new and innovative research questions. Optimizing the linkage consent rate is a critical step toward realizing the scientific advantages of record linkage and minimizing the risk of linkage consent bias. Linkage consent rates have been shown to be particularly sensitive to certain design features, such as where the consent question is placed in the questionnaire and how the question is framed. However, the interaction of these design features and their relative contributions to the linkage consent rate have never been jointly studied, raising the practical question of which design feature (or combination of features) should be prioritized from a consent rate perspective. We address this knowledge gap by reporting the results of a placement and framing experiment embedded within separate telephone and Web surveys. We find a significant interaction between placement and framing of the linkage consent question on the consent rate. The effect of placement was larger than the effect of framing in both surveys, and the effect of framing was only evident in the Web survey when the consent question was placed at the end of the questionnaire. Both design features had negligible impact on linkage consent bias for a series of administrative variables available for consenters and non-consenters. We conclude this research note with guidance on the optimal administration of the linkage consent question.

The Whole Genome Sequencing Project initiated by The Hospital for Sick Children of Toronto intents to enroll patients between one to eighteen years of age with congenital heart disease to test the efficiency of such a method for potential personalized diagnoses and treatments. Twenty-five randomly approached patients were chosen to be observed of their consent rate to the project based on factors of age, gender, ethnicity, presence of heart diseases in the patient’s family, and type of congenital heart disease represented. Females and ethnicities not of European descent are considered to be a part of the minority groups, generally being under represented thus having a lower consent rate. There were no significant correlations between consent rates and familial history of heart disease, type of heart disease and age groups. All these findings can aid in future studies of the SickKids Hospital; which patients should be approached for higher consent rates, and the inclusivity of minority groups to alleviate bias in medical studies.

Background Various actions have been taken during the last decade to increase the number of organs from deceased donors available for transplantation in Switzerland. This study provides an overview on key figures of the Swiss deceased organ donation and transplant activity between 2008 and 2017. In addition, it puts the evolution of the Swiss donation program’s efficiency in relation to the situation in the neighboring countries. Methods This study is an analysis of prospective registry data, covering the period from 1 January 2008 to 31 December 2017. It includes all actual deceased organ donors (ADD) in Switzerland. Donor data were extracted from the Swiss Organ Allocation System. The “donor conversion index” (DCI) methodology and data was used for the comparison of donation program efficiency in Switzerland, Germany, Austria, Italy and France. Results During the study period there were 1116 ADD in Switzerland. The number of ADD per year increased from 91 in 2008 to 145 in 2017 (+ 59%). The reintroduction of the donation after cardiocirculatory death (DCD) program in 2011 resulted in the growth of annual percentages of DCD donors, reaching a maximum of 27% in 2017. The total number of organs transplanted from ADD was 3763 (3.4 ± 1.5 transplants per donor on average). Of these, 48% were kidneys (n = 1814), 24% livers (n = 903), 12% lungs (n = 445), 9% hearts (n = 352) and 7% pancreata or pancreatic islets (n = 249). The donation program efficiency assessment showed an increase of the Swiss DCI from 1.6% in 2008 to 2.7% in 2017 (+ 69%). The most prominent efficiency growth was observed between 2012 and 2017. Even though Swiss donation efficiency increased during the study period, it remained below the DCI of the French and Austrian donation programs. Conclusion Swiss donation activity and efficiency grew during the last decade. The increased donation efficiency suggests that measures implemented so far were effective. The lower efficiency of the Swiss donation program, compared to the French and Austrian programs, may likely be explained by the lower consent rate in Switzerland. This issue should be addressed in order to achieve the goal of more organs available for transplantation.

Background: The number of deceased donors that have increased annually until 2016 has started to decline in the last three years. This study therefore intends to analyze the trend of potential brain death reported to Korea Organ Donation Agency (KODA) and use the analysis results as a basic data for the activation of organ donation. Methods: A comparative analysis was performed for the first period (P1: 2014 to 2016) where the number of donations continued to increase and the second period (P2: 2017 to 2019) that showed decline in donations compared to 2016. Results: The cases of potential brain death reported to KODA was 5,548 in P1 and 7,126 in P2, a 28.4% increase from the previous period. Among these, the cases of medically suitable for organ donation increased by 36.5%, from 4,053 in P1 to 5,534 in P2. Decreased the consent rate from 52.9% in P1 to 37.2% in P2. The discontinuation of donation process even after family consent increased by 17.6% (from 74 cases in P1 to 87 cases in P2), mostly due to legal issues and death before the judgment of brain death. Conclusions: The decrease in families’ consent for organ donation turned out to be the biggest cause of declining donation. The major reasons for refusal to donation such as can be attributed to the lack of understanding of the medical state of brain death, a negative image of sharing and donation that is pervasive in Korean society, and the distrust between community members. Therefore, there is a need for education and promotion at a national level to enhance the awareness of the value of life and to en courage the public to practice the value of sharing.

Summary The refusal rate for organ donation in the UK is 42%, among the highest in Europe. We extracted data on every family approach for donation in UK ICUs or Emergency Departments between 1st April 2012 and 30th September 2013, and performed multiple logistic regression to identify modifiable factors associated with consent. Complete data were available for 4703 of 4899 approaches during the study period. Consent for donation after brain death was 68.9%, and for donation after circulatory death 56.5% (p

Background: According to the statistics of the National Agency for Management of Life-Sustaining Treatment, 85,000 end of life care patients have been withdrawn life sustaining treatment over two years since the implementation of law in February 2018. However, according to annual report of Korea Organ Donation Agency (KODA), there were a considerable number of patients who requested to withdraw life sustaining treatment among the referred potential brain death to the call center of KODA. Their family consent rate was lower than the group that didn’t mentioned about interrupting the end of life care. Methods: The study was designed using the referred cases of potential brain death to KODA during 2018 and 2019. Demographic findings of requesting withdrawn life sustaining treatment among the referred cases and their result of donation progress in each step were evaluated. Results: Within the research period, there were a total of 4,910 cases (2,426 in 2018, 2,484 in 2019) of brain death, and among them, 569 (193 in 2018 and 376 in 2019) cases requested to withdraw life sustaining treatment. This means a 94.8% increase in requesting family compared to the previous year. In terms of gender, 63% of the cases were male, and the most common age group was the fifties (23.4%). Among 569 requested donors, 475 (83.5%) were appropriate for organ donation, out of which, 394 (82.9%) families were interviewed about organ donation, and accepted organ donation in 45 cases (9.5%). Only 29 cases (6.1%) were succeeded in organ procurement. Conclusions: It is estimated that there will be more families who wish to withdraw life sustaining treatment among potential brain death referred to KODA for organ donation in the future. Therefore, in order to activate organ donations, we need a system revision about end of life care process, first to the donor coordinator and then explain all the options by that coordinator.

Privacy literature in recent years has emphasized the role of context and situation in individuals' privacy regulation. While most research is focused on understanding situational effects on self-disclosure, the role of situational factors in users’ decision to consent for third-party access to information, a common practice with significant privacy implications, has been barely investigated. The current study bridges this gap by adopting the framework of situational privacy to examine the effect of the purpose for information collection on participants' consent. An online experiment examined users' consent to allow access to their Facebook profile to an unknown entity, with requests distinguished by the framing of the purpose for collecting information as related to security, commercial or academic research. Contrary to the study’s hypothesis, consent rate was similar between groups and purpose was non-significant in explaining participants’ decisions. Furthermore, in all three groups- compensation amount and general willingness to disclose information explain user consent, regardless of purpose. However, some specific factors significantly correlate with consent in each group separately. The study concludes that due to blurring boundaries and uncertainties regarding real uses of information, when it comes to consent for third-party access, predetermined attitudes and preferences are main factors influencing users’ decisions, thus a situational framework is partly adequate for explaining variations in user consent decisions.

Supplemental Digital Content is Available in the Text., Introduction: Multimodal characterisation with questionnaires, Quantitative Sensory Testing (QST), and neuroimaging will improve understanding of neuropathic pain (NeuP) in adolescents. Magnetic resonance imaging (MRI) data in adolescents with NeuP are limited, and the perceived practical or ethical burden of scanning may represent a barrier to research. Objective: To determine the feasibility of MRI scanning in adolescents with moderate–severe NeuP, with respect to consent rate, postscan acceptability, and data quality. Methods: This prospective cohort study evaluating questionnaires and QST recruited adolescents aged 10 to 18 years with clinically diagnosed NeuP from a tertiary clinic. Eligible adolescents aged 11 years and older could additionally agree/decline an MRI scan. After the scan, families rated discomfort, perceived risk, and acceptability of current and future MRI scans (0–10 numerical rating scales). Head motion during scanning was compared with healthy controls to assess data quality. Results: Thirty-four families agreed to MRI (72% recruitment), and 21 adolescents with moderate–severe pain (average last week 6.7 ± 1.7; mean ± SD) and with neuropathic QST profiles were scanned. Three adolescents reported positional or noise-related discomfort during scanning. Perceived risk was low, and acceptability of the current scan was high for parents (range [median]: 7 to 10/10 [10]) and adolescents (8–10/10 [10]). Willingness to undergo a future research scan was high for parents (7–10/10 [10]) and adolescents (5–10/10 [10]) and did not differ from future scans for clinical purposes. Mean head motion during resting state functional MRI did not differ from control adolescents. Conclusion: Research MRI is feasible and acceptable for many adolescents with moderate–severe NeuP.

ObjectiveThe present study examined food and beverage distributors’ sourcing, placement and promotion of obesogenic (energy-dense, nutrient-poor) product categories from the perspective of small food store owners/managers. The obesogenic product categories of interest were savoury snacks, sugary beverages, sweet snacks, confectionery and frozen treats. Specifically, we examined how frequently distributors sourced these products, and the types of agreements and expectations they had for their placement and promotion. Differences were explored by store size and ethnicity. Fresh produce was used as a comparison when examining differences in frequency of sourcing only, with implications for healthy food access.DesignSurvey research involving in-person interviews.SettingFour urban areas in the USA: Baltimore, MD; Durham, NC; Minneapolis/St. Paul, MN; and San Diego, CA.SubjectsSeventy-two small food store owners/managers, 65 % consent rate.ResultsMost distributors sourced obesogenic products weekly. Agreements to place products were predominantly informal (e.g. handshake) with sweet snack, confectionery and frozen treat distributors, and formal (e.g. contract) with savoury snack and sugary beverage distributors. Free-standing displays were the most common incentive provided by distributors and they expected some control over their placement and pricing. Free/discounted products and signage were also common incentives but slotting fees were not. Smaller stores and ethnic stores were less likely to receive various incentives, but among sweet snack distributors, they were more likely to control the price in ethnicv. non-ethnic stores.ConclusionsObesogenic products are ubiquitous. Influencing what is made available to consumers in the retail food environment needs to consider the distributor.

Objective The aim of this study was to explore how and why Australian men with cancer practice complementary therapies (CTs) and how their significant others (SOs) contribute to the regular uptake of CTs. Methods This qualitative study employed semi-structured interviews with 26 male cancer patients and 24 SOs. Participants were purposefully sampled from a preceding Australian survey investigating the use of CTs in men with cancer (94% response rate and 86% consent rate for follow-up interview). Interviews were conducted in a metropolitan location, and the 43 interview transcripts were analyzed thematically. Results Three core themes were identified: men used CTs as (a) problem-focused coping (e.g., diet modification), (b) emotion-focused coping (e.g., meditation), and (c) meaning-based coping (e.g., prayer). Practicing CTs helped men to cope with physical, emotional, and spiritual concerns, although some men spoke of difficulties with practicing meditation to regulate their emotions. SOs were supportive of men's coping strategies but were only rarely involved in men's emotion-focused coping. Conclusions Complementary therapies have the potential to facilitate coping with cancer, independent of any measurable physiological benefit. Our findings suggest that when clinicians engage in conversations about CTs use, they should consider the type of coping strategy employed by their patient. Such information may enhance the efficacy of some interventions (e.g., meditation) and also provide for an opportunity to discuss patients' expectations concerning CTs. Copyright © 2014 John Wiley & Sons, Ltd.

Aims School-based research involves a multi-level process to ensure recruitment of an adequate and reliable sample. The aim of this study is to present the experience of school recruitment of the DEMOCOPHES study in Cyprus. Moreover, methods and strategies to improve recruitment rates are described. Methods The target population of the DEMOCOPHES study was children aged 6-11 years old and their mothers. Cyprus was required to recruit 60 children and their mothers. Random selection of the schools was followed. The information material was provided to the teacher of the selected classes who subsequently distributed it to the children. Personal follow-up contact via telephone call was made with the parents living in the rural areas only. Results Twenty one percent eligibility and consent rate for participation was reached. In schools where parents were followed-up by telephone calls, the response rate was significantly higher compared to those not followed-up by reminders (58% vs 42%, p< 0.05). Conclusions Despite the limitations of applicability and representativity, school-based recruitment has been shown to be a feasible and reliable strategy. It is an attractive approach of enrolling young populations into epidemiological studies. Follow-up reminders via telephone calls significantly increased the response rate.

Background The Organ Donation Breakthrough Collaborative (ODBC) was established in 2003 to increase the number of transplantable organs in the United States. However, recent publications have suggested that the ODBC has not impacted donation conversion rates at local organ procurement organizations (OPOs). We sought to determine the impact, if any, of our becoming part of the ODBC on organ donation rates in our OPO or in our institution (Carolinas Medical Center [CMC]), particularly among minority donors. Methods This is a retrospective review of data entered concurrently into a patient referral database maintained by our local OPO. Donation approach and consent rates were calculated. They were then analyzed by race and institution, and trends were analyzed over the study period of 2002 to 2010. Statistical differences between the various patient groups were determined by the chi-square test or the Fisher exact test. Statistical differences over time were determined by the Cochran-Armitage trend test. Results From 2002 to 2010, 10,855 patients were screened by our OPO for potential organ donation. The overall approach rate was 13.4%, and the consent rate was 57.6%. An increase in approach and consent rates was noted beginning in 2004, but this increase was not sustained. Consent rates in general were higher for white patients than for black and Hispanic patients. Consent rates for CMC did increase significantly (P = .02), but they did not increase for the non-CMC hospitals. When analyzed by race, no significant changes were noted in consent rates over time. When analyzed by race and institution, the only statistically significant increase in consent rates occurred for white patients at CMC. Conclusions Since joining the ODBC, we have noted an increase in consent rates at a single institution (CMC), but no other significant changes. Greater emphasis should be placed on methods to increase and sustain consent rates for all racial groups in general, with a special emphasis on increasing consent rates in minority patients.

Aims To present our experience of prospective telephone consenting for post-mortem CT angiography (PMCT-A) research using HM coroners’ cases. Methods Local ethics committee, research and development office, and local HM coroners gave their permission for the families of the deceased, in cases where a ‘routine’ coroner9s autopsy had been authorised, to be approached for their consent to PMCT-A research before the autopsy examination. A forensic pathologist or trial consenter telephoned the next of kin, discussed the nature of the study and obtained verbal informed consent for post-mortem imaging, angiography, case-dependent histological and toxicology sampling and for the use of the images for teaching and training. Thematic analyses of the reasons for giving or refusing consent are provided. Results Of the 207 cases approached, seven relatives refused to enter their next of kin into the study (96.6% consent rate). Conclusions This study shows that prospective consenting for HM coroners’ cases to be used for autopsy research is feasible in adults, and can be done ethically, and in the limited time available, by obtaining the consent of the next of kin by telephone before autopsy.

As brain death is a difficult concept for the lay public to understand, we hypothesized that allowing relatives of the patient to be present during brain death determination would improve their understanding of this condition and would eventually lead to an increased consent rate for organ donation.A prospective multicenter trial was conducted in five Dutch hospitals. Relatives were given the opportunity to be present during brain death testing. The family consent rate for organ donation was the primary endpoint examined, and the degree of the relatives' understanding of brain death was the secondary endpoint.Between April 2010 and July 2011, we included the relatives of 8 patients in this study. The relatives witnessed brain death testing during this time. This sample size was too small to draw valid statistical conclusions. However, we have documented some noteworthy experiences of the relatives.Although, the hypothesis behind this study had promise, we were unable to reach our predefined goal. The possible causes for this shortcoming included the rarity of patients with brain death, the common practice in the Netherlands of obtaining consent for organ donation before brain death testing and the uneasiness of the staff in the presence of the patients' relatives during brain death determination. Although, we cannot draw a conclusion from statistical evidence, we would recommend that relatives be given the opportunity to be present during brain death testing and, specifically, during the apnea test.

Objective: We present the operational organization and daily workflow of our Hamburg model and the results of the years 2007–2011 concerning donation of corneas, musculoskeletal and, since 2010, cardiovascular tissues. Methods: Each of the about 3,600 deceased every year undergoes an evaluation process by two coordinators on duty, the tissue coordinator and the family coordinator. All donation connected issues are carried out within the standardized protocols of a quality management system and documented in a special data base. Two catamnestic surveys evaluated the satisfaction of donor families retrospectively. The inclusion rate for cornea donation was 23% and for musculoskeletal donation 10%, with a decrease after the 75 years age restriction of musculoskeletal donors in 2011 defined by the contracting tissue bank German Institute for Cell and Tissue Replacement gGmbH (DIZG), Berlin. Results: Since 2007 1,268 corneas were explanted altogether, reflecting an increasing explantation rate from 156 (University Medical Center Hamburg-Eppendorf (UMC: 9) in 2007 up to 304 (UMC: 52) in 2011. Overall 173 musculoskeletal donors (5 years) and 11 cardiovascular donors (2 years) spent tissues. The consent rate was much higher. The evaluation of the families reflected a positive feedback for the guiding of the donation process. Conclusion: Forensic institutes can act as an interface between donors and recipients without neglecting forensic investigations. They are uniquely positioned to recognize potential donors. In addition, the contact with a physician of the forensic institute may help families during the mourning phase.