Promoting deceased organ and tissue donation registration in family physician waiting rooms (RegisterNow-1): a pragmatic stepped-wedge, cluster randomized controlled registry trial.

BACKGROUND: The shortage of available organs for life-saving transplants persists worldwide. While a majority support donating their organs or tissue when they die, many have not registered their wish to do so. When registered, next of kin are much more likely to follow-through with the decision to donate. In many countries, most people visit their family physician office each year and this setting is a promising, yet underused, site where more people could register for deceased organ donation. Our primary aim was to evaluate the effectiveness of an intervention to promote organ donation registration in family physician's offices. METHODS: We developed an intervention to address barriers and enablers to organ donation registration that involved physician office reception staff inviting patients to register on a tablet in the waiting room while they waited for their appointment. We conducted a cross-sectional stepped-wedge cluster randomized controlled registry trial to evaluate the intervention. We recruited six family physician offices in Canada. All offices began with usual care and then every two weeks, one office (randomly assigned) started the intervention until all offices delivered the intervention. The primary outcome was registration for deceased organ donation in the provincial organ registration registry, assessed within the 7 days of the physician visit. At the end of the trial, we also conducted interviews with clinic staff to assess any barriers and enablers to delivering the intervention. RESULTS: The trial involved 24,616 patient visits by 13,562 unique patients: 12,484 visits in the intervention period and 12,132 in the control period. There was no statistically significant difference in the percentage of patients registered for deceased organ donation in the intervention versus control period (48.0% vs 46.2%; absolute difference after accounting for the secular trend: 0.12%; 95% CI: - 2.30, 2.54; p=0.92). Interviews with clinic staff indicated location of the tablet within a waiting room, patient rapport, existing registration, confidence and motivation to deliver the intervention and competing priorities as barriers and enablers to delivery. CONCLUSIONS: Our intervention did not increase donor registration. Nonetheless, family physician offices may still remain a promising setting to develop and evaluate better interventions to increase organ donation registration. TRIAL REGISTRATION: NCT03213171.

Effects of quality-based procedure hospital funding reform in Ontario, Canada: An interrupted time series study.

BACKGROUND: The Government of Ontario, Canada, announced hospital funding reforms in 2011, including Quality-based Procedures (QBPs) involving pre-set funds for managing patients with specific diagnoses/procedures. A key goal was to improve quality of care across the jurisdiction. METHODS: Interrupted time series evaluated the policy change, focusing on four QBPs (congestive heart failure, hip fracture surgery, pneumonia, prostate cancer surgery), on patients hospitalized 2010-2017. Outcomes included return to hospital or death within 30 days, acute length of stay (LOS), volume of admissions, and patient characteristics. RESULTS: At 2 years post-QBPs, the percentage of hip fracture patients who returned to hospital or died was 3.13% higher in absolute terms (95% CI: 0.37% to 5.89%) than if QBPs had not been introduced. There were no other statistically significant changes for return to hospital or death. For LOS, the only statistically significant change was an increase for prostate cancer surgery of 0.33 days (95% CI: 0.07 to 0.59). Volume increased for congestive heart failure admissions by 80 patients (95% CI: 2 to 159) and decreased for hip fracture surgery by 138 patients (95% CI: -183 to -93) but did not change for pneumonia or prostate cancer surgery. The percentage of patients who lived in the lowest neighborhood income quintile increased slightly for those diagnosed with congestive heart failure (1.89%; 95% CI: 0.51% to 3.27%) and decreased for those who underwent prostate cancer surgery (-2.08%; 95% CI: -3.74% to -0.43%). INTERPRETATION: This policy initiative involving a change to hospital funding for certain conditions was not associated with substantial, jurisdictional-level changes in access or quality.

Exploring the experiences and perspectives of substitute decision-makers involved in decisions about deceased organ donation: a qualitative study protocol.

INTRODUCTION: In Canada, deceased organ donation provides over 80% of transplanted organs. At the time of death, families, friends or others assume responsibility as substitute decision-makers (SDMs) to consent to organ donation. Despite their central role in this process, little is known about what barriers, enablers and beliefs influence decision-making among SDMs. This study aims to explore the experiences and perspectives of SDMs involved in making decisions around the withdrawal of life-sustaining therapies, end-of-life care and deceased organ donation. METHODS AND ANALYSIS: SDMs of 60 patients admitted to intensive care units will be enrolled for this study. Ten hospitals across five provinces in Canada in a prospective multicentre qualitative cohort study. We will conduct semistructured telephone interviews in English or French with SDMs between 6 and 8 weeks after the patient's death. Our sampling frame will stratify SDMs into three groups: SDMs who were not approached for organ donation; SDMs who were approached and consented to donate and SDMs who were approached but did not consent to donate. We will use two complementary theoretical frameworks-the Common-Sense Self-Regulation Model and the Theoretical Domains Framework- to inform our interview guide. Interview data will be analysed using deductive directed content analysis and inductive thematic analysis. ETHICS AND DISSEMINATION: This study has been approved by the Centre Hospitalier de l'Université de Montréal Research Ethics Board. The findings from this study will help identify key factors affecting substitute decision-making in deceased organ donation, reasons for non-consent and barriers to achieve congruency between SDM and patient wishes. Ultimately, these data will contribute to the development and evaluation of tools and training for healthcare providers to support SDMs in making decisions about organ donation. TRIAL REGISTRATION NUMBER: NCT03850847.

Familial Consent for Deceased Organ Donation Among Immigrants and Long-term Residents in Ontario, Canada: A Population-Based Retrospective Cohort Study.

BACKGROUND: Many families choose not to consent to organ donation at the time of their loved one's death. In Ontario, Canada, whether these decisions vary by ethnicity remains unclear. OBJECTIVE: To compare the proportion of families of immigrants who consented for deceased organ donation with families of long-term residents. DESIGN: Population-based retrospective cohort study. SETTING: Potential donors in Ontario, Canada, between November 2008 and March 2013. METHODS: We used linked administrative databases to study the proportion of families who consented for deceased organ donation. RESULTS: Overall, of the 2873 families of potential donors approached, 1912 (67%) provided consent for deceased organ donation. Families of immigrants were less likely to provide consent compared with families of long-term residents (46% [135 of 291] vs 69% [1777 of 2582]; adjusted rate ratio (RR): 0.72; 95% confidence interval [CI]: 0.63-0.81). When examined by the country of birth, families of immigrants from the following regions were less likely to consent to organ donation compared with long-term residents: South Asia (RR: 0.71; 95% CI: 0.55-0.91), East Asia and Pacific (RR: 0.68; 95% CI: 0.53-0.88) and Middle East, North Africa, and sub-Saharan Africa (RR: 0.58; 95% CI: 0.37-0.91). LIMITATIONS: We could not determine why consent was not obtained. We had a small sample of immigrants. We only had access to the potential donors' information and not the family member who was approached for consent. Many characteristics that we examined were nonmodifiable (eg, age, sex). CONCLUSIONS: In Ontario, families of immigrants are less likely to consent to deceased organ donation. There is an opportunity to better understand the reasons for lower consent among certain immigrant groups.

CONTEXTE: À la mort d'un être cher, plusieurs familles refusent de consentir au don d'organes. Au Canada, particulièrement dans la province de l'Ontario, il demeure difficile d'établir si une telle décision varie selon l'origine ethnique des personnes concernées. OBJECTIF DE L'ÉTUDE: L'étude visait à comparer la proportion de familles issues de l'immigration ayant consenti au don d'organe après le décès d'un proche à celle de familles résidant au pays depuis longtemps. TYPE D'ÉTUDE: Il s'agit d'une étude de cohorte rétrospective basée sur une population. CADRE DE L'ÉTUDE: On a ciblé les familles résidant en Ontario, au Canada, qui avaient été abordées entre septembre 2008 et mars 2013 en vue de faire don des organes et des tissus d'un proche décédé. MÉTHODOLOGIE: Nous avons utilisé les bases de données couplées du système de santé pour établir la proportion de familles ayant consenti au don d'organes d'un proche décédé. RÉSULTAT: Dans l'ensemble, la majorité des 2 873 familles abordées, soit 1 912 (67 %), a consenti au don d'organes de leur proche décédé. Nous avons toutefois constaté que les familles issues de l'immigration se sont montrées plus réticentes à consentir au don d'organes que les familles de résidents de longue date (46 % [135 of 291] contre 69 % [1777 of 2582]; RR à 0,72 %; IC 95 % : 0,63 à 0,81). La comparaison sur la base du pays d'origine a permis d'établir que les personnes en provenance des régions suivantes étaient plus susceptibles de refuser de donner leur consentement : Asie du Sud (RR à 0,71; IC 95 % : 0,55 à 0,91), Asie de l'Est et du Pacifique (RR à 0,68; IC 95 % : 0,53 to 0,88), Moyen-Orient, Afrique du Nord et Afrique subsaharienne (RR à 0,58; IC 95 % : 0,37 to 0,91). LIMITES: La portée des résultats de cette étude pourrait être limitée par plusieurs facteurs : notamment, nous n'avons pas pu obtenir d'information sur les raisons du refus de consentement, nous n'avions accès qu'aux renseignements du donneur potentiel et non à ceux des membres de la famille abordés pour la demande de consentement. Ajoutons à cela la taille restreinte de l'échantillon des familles issues de l'immigration et le fait que plusieurs des caractéristiques examinées n'étaient pas modifiables (l'âge ou le sexe, par exemple). CONCLUSION: Cette étude conclut qu'en Ontario, les familles issues de l'immigration sont plus réticentes à consentir au don d'organes et de tissus d'un proche décédé. Dès lors, une occasion nous est offerte pour tenter de mieux comprendre les raisons qui expliquent cette faible proportion de consentement chez certains groupes d'immigrants.

Improving safety culture in hospitals: Facilitators and barriers to implementation of Systemic Falls Investigative Method (SFIM).

OBJECTIVE: The purpose of this study was to assess the facilitators and barriers to implementation of the Systemic Falls Investigative Method (SFIM) on selected hospital units. DESIGN: A cross-sectional explanatory mixed methods design was used to converge results from a standardized safety culture survey with themes that emerged from interviews and focus groups. Findings were organized by six elements of the Ottawa Model of Research Use framework. SETTING: A geriatric rehabilitation unit of an acute care hospital and a neurological unit of a rehabilitation hospital were selected purposefully due to the high frequency of falls. PARTICIPANTS: Hospital staff who took part in: surveys (n = 39), interviews (n = 10) and focus groups (n = 12), and 38 people who were interviewed during falls investigations: fallers, family, unit staff and hospital management. INTERVENTION: Implementation of the SFIM to investigate fall occurrences. MAIN OUTCOME MEASURE(S): Percent of positive responses on the Modified Stanford Patient Safety Culture Survey Instrument converged with qualitative themes on facilitators and barriers for intervention implementation. RESULTS: Both hospital units had an overall poor safety culture which hindered intervention implementation. Facilitators were hospital accreditation, strong emphasis on patient safety, infrastructure and dedicated champions. Barriers included heavy workloads, lack of time, lack of resources and poor communication. CONCLUSIONS: Successful implementation of SFIM requires regulatory and organizational support, committed frontline staff and allocation of resources to identify active causes and latent contributing factors to falls. System-wide adjustments show promise for promotion of safety culture in hospitals where falls happen regularly.

Evolution of Reporting P Values in the Biomedical Literature, 1990-2015.

IMPORTANCE: The use and misuse of P values has generated extensive debates. OBJECTIVE: To evaluate in large scale the P values reported in the abstracts and full text of biomedical research articles over the past 25 years and determine how frequently statistical information is presented in ways other than P values. DESIGN: Automated text-mining analysis was performed to extract data on P values reported in 12,821,790 MEDLINE abstracts and in 843,884 abstracts and full-text articles in PubMed Central (PMC) from 1990 to 2015. Reporting of P values in 151 English-language core clinical journals and specific article types as classified by PubMed also was evaluated. A random sample of 1000 MEDLINE abstracts was manually assessed for reporting of P values and other types of statistical information; of those abstracts reporting empirical data, 100 articles were also assessed in full text. MAIN OUTCOMES AND MEASURES: P values reported. RESULTS: Text mining identified 4,572,043 P values in 1,608,736 MEDLINE abstracts and 3,438,299 P values in 385,393 PMC full-text articles. Reporting of P values in abstracts increased from 7.3% in 1990 to 15.6% in 2014. In 2014, P values were reported in 33.0% of abstracts from the 151 core clinical journals (n = 29,725 abstracts), 35.7% of meta-analyses (n = 5620), 38.9% of clinical trials (n = 4624), 54.8% of randomized controlled trials (n = 13,544), and 2.4% of reviews (n = 71,529). The distribution of reported P values in abstracts and in full text showed strong clustering at P values of .05 and of .001 or smaller. Over time, the "best" (most statistically significant) reported P values were modestly smaller and the "worst" (least statistically significant) reported P values became modestly less significant. Among the MEDLINE abstracts and PMC full-text articles with P values, 96% reported at least 1 P value of .05 or lower, with the proportion remaining steady over time in PMC full-text articles. In 1000 abstracts that were manually reviewed, 796 were from articles reporting empirical data; P values were reported in 15.7% (125/796 [95% CI, 13.2%-18.4%]) of abstracts, confidence intervals in 2.3% (18/796 [95% CI, 1.3%-3.6%]), Bayes factors in 0% (0/796 [95% CI, 0%-0.5%]), effect sizes in 13.9% (111/796 [95% CI, 11.6%-16.5%]), other information that could lead to estimation of P values in 12.4% (99/796 [95% CI, 10.2%-14.9%]), and qualitative statements about significance in 18.1% (181/1000 [95% CI, 15.8%-20.6%]); only 1.8% (14/796 [95% CI, 1.0%-2.9%]) of abstracts reported at least 1 effect size and at least 1 confidence interval. Among 99 manually extracted full-text articles with data, 55 reported P values, 4 presented confidence intervals for all reported effect sizes, none used Bayesian methods, 1 used false-discovery rates, 3 used sample size/power calculations, and 5 specified the primary outcome. CONCLUSIONS AND RELEVANCE: In this analysis of P values reported in MEDLINE abstracts and in PMC articles from 1990-2015, more MEDLINE abstracts and articles reported P values over time, almost all abstracts and articles with P values reported statistically significant results, and, in a subgroup analysis, few articles included confidence intervals, Bayes factors, or effect sizes. Rather than reporting isolated P values, articles should include effect sizes and uncertainty metrics.

Early Hospital Readmissions After Transplantation: Burden, Causes, and Consequences.

BACKGROUND: Solid organ transplantation is the preferred treatment for patients with end-stage organ failure. Although much progress has been made over the past decade, some patients still require early readmission after their initial hospital discharge. Early hospital readmission is an important metric for health care quality. It is often measured in nontransplant medical and surgical conditions but has only recently been applied to organ transplantation. METHODS: We performed a structured MEDLINE search to retrieve, review, and summarize original studies on the incidence, risk factors, outcomes, and prevention of early hospital readmissions after kidney, liver, and kidney-pancreas transplantation. Early hospital readmission was defined as readmission to hospital within 30 days of discharge from the transplant hospitalization. RESULTS: The risk of early readmission varies by organ type, (highest in liver transplants and lowest in kidney transplants). Causes for early hospital readmission are most commonly due to surgical, immunologic, or infectious complications. Risk factors associated with early hospital readmission often reflect pretransplant comorbidity, and many of these factors may not be modifiable. Early hospital readmission is also associated with decreased graft and patient survival. CONCLUSIONS: Early hospital readmission after transplantation is common and associated with adverse outcomes. The potential for preventing early hospital readmissions and the impact on patient outcomes remain unclear. Current evidence suggests that some, but not all, early hospital readmissions after transplantation may be prevented.

Registration for deceased organ and tissue donation among Ontario immigrants: a population-based cross-sectional study.

BACKGROUND: Canada has low rates of deceased organ and tissue donation. Immigrants to Canada may differ in their registered support for deceased organ donation based on their country of origin. METHODS: We used linked administrative databases in Ontario (about 11 million residents aged ≥ 16 yr) to study the proportion of immigrants and long-term residents registered for deceased organ and tissue donation as of October 2013. We used modified Poisson regression to identify and quantify predictors of donor registration. RESULTS: Compared with long-term residents (n = 9 244 570), immigrants (n = 1 947 646) were much less likely to register for deceased organ and tissue donation (11.9% v. 26.5%). Immigrants from the United States, Australia and New Zealand had the highest registration rate (40.0%), whereas immigrants with the lowest registration rates were from Eastern Europe and Central Asia (9.4%), East Asia and Pacific (8.4%) and sub-Saharan Africa (7.9%). The largest numbers of unregistered immigrants were from India (n = 202 548), China (n = 186 678) and the Philippines (n = 125 686). Characteristics among the immigrant population associated with a higher likelihood of registration included economic immigrant status, living in a rural area (population < 10 000), living in an area with a lower ethnic concentration, less material deprivation, a higher education, ability to speak English and French, and more years residing in Canada. INTERPRETATION: Immigrants in Ontario were less likely to register for deceased organ and tissue donation than long-term residents. There is a need to better understand reasons for lower registration rates among Canadian immigrants and to create culture-sensitive materials to build support for deceased organ and tissue donation.

Deceased Organ Donation Registration and Familial Consent among Chinese and South Asians in Ontario, Canada.

OBJECTIVE: For various reasons, people of Chinese (China, Hong Kong or Taiwan) and South Asian (Indian subcontinent) ancestry (the two largest ethnic minority groups in Ontario, Canada) may be less likely to register for deceased organ donation than the general public, and their families may be less likely to consent for deceased organ donation at the time of death. METHODS: We conducted two population-based studies: (1) a cross-sectional study of deceased organ donor registration as of May 2013, and (2) a cohort study of the steps in proceeding with deceased organ donation for patients who died in hospital from October 2008 to December 2012. RESULTS: A total of 49 938 of 559 714 Chinese individuals (8.9%) and 47 774 of 374 291 South Asians (12.8%) were registered for deceased organ donation, proportions lower than the general public (2 676 260 of 10 548 249 (25.4%). Among the 168 703 Ontarians who died in a hospital, the families of 33 of 81 Chinese (40.1%; 95% CI: 30.7%-51.6%) and 39 of 72 South Asian individuals (54.2%; 95% CI: 42.7-65.2%) consented for deceased organ donation, proportions lower than the general public (68.3%; 95% CI: 66.4%-70.0%). CONCLUSIONS: In Ontario, Canada Chinese and South Asian individuals are less likely to register and their families are less likely to consent to deceased organ donation compared to the remaining general public. There is an opportunity to build support for organ and tissue donation in these two large ethnic communities in Canada.

Quality of survey reporting in nephrology journals: a methodologic review.

BACKGROUND AND OBJECTIVES: Survey research is an important research method used to determine individuals' attitudes, knowledge, and behaviors; however, as with other research methods, inadequate reporting threatens the validity of results. This study aimed to describe the quality of reporting of surveys published between 2001 and 2011 in the field of nephrology. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: The top nephrology journals were systematically reviewed (2001-2011: American Journal of Kidney Diseases, Nephrology Dialysis Transplantation, and Kidney International; 2006-2011: Clinical Journal of the American Society of Nephrology) for studies whose primary objective was to collect and report survey results. Included were nephrology journals with a heavy focus on clinical research and high impact factors. All titles and abstracts were screened in duplicate. Surveys were excluded if they were part of a multimethod study, evaluated only psychometric characteristics, or used semi-structured interviews. Information was collected on survey and respondent characteristics, questionnaire development (e.g., pilot testing), psychometric characteristics (e.g., validity and reliability), survey methods used to optimize response rate (e.g., system of multiple contacts), and response rate. RESULTS: After a screening of 19,970 citations, 216 full-text articles were reviewed and 102 surveys were included. Approximately 85% of studies reported a response rate. Almost half of studies (46%) discussed how they developed their questionnaire and only a quarter of studies (28%) mentioned the validity or reliability of the questionnaire. The only characteristic that improved over the years was the proportion of articles reporting missing data (2001-2004: 46.4%; 2005-2008: 61.9%; and 2009-2011: 84.8%; respectively) (P<0.01). CONCLUSIONS: The quality of survey reporting in nephrology journals remains suboptimal. In particular, reporting of the validity and reliability of the questionnaire must be improved. Guidelines to improve survey reporting and increase transparency are clearly needed.

Validity of physician billing claims to identify deceased organ donors in large healthcare databases.

OBJECTIVE: We evaluated the validity of physician billing claims to identify deceased organ donors in large provincial healthcare databases. METHODS: We conducted a population-based retrospective validation study of all deceased donors in Ontario, Canada from 2006 to 2011 (n = 988). We included all registered deaths during the same period (n = 458,074). Our main outcome measures included sensitivity, specificity, positive predictive value, and negative predictive value of various algorithms consisting of physician billing claims to identify deceased organ donors and organ-specific donors compared to a reference standard of medical chart abstraction. RESULTS: The best performing algorithm consisted of any one of 10 different physician billing claims. This algorithm had a sensitivity of 75.4% (95% CI: 72.6% to 78.0%) and a positive predictive value of 77.4% (95% CI: 74.7% to 80.0%) for the identification of deceased organ donors. As expected, specificity and negative predictive value were near 100%. The number of organ donors identified by the algorithm each year was similar to the expected value, and this included the pre-validation period (1991 to 2005). Algorithms to identify organ-specific donors performed poorly (e.g. sensitivity ranged from 0% for small intestine to 67% for heart; positive predictive values ranged from 0% for small intestine to 37% for heart). INTERPRETATION: Primary data abstraction to identify deceased organ donors should be used whenever possible, particularly for the detection of organ-specific donations. The limitations of physician billing claims should be considered whenever they are used.

Adolescent classroom education on knowledge and attitudes about deceased organ donation: a systematic review.

In many countries, adolescents can choose to register a deceased organ donation wish when they apply for a driver's license. They often receive education about deceased organ donation in order to make an informed choice. The objective of this review was to describe the effectiveness of school-based educational programs on deceased organ donation among adolescents. We reviewed any study of adolescent students receiving a school-based educational program on deceased organ donation. The outcomes were knowledge, attitudes, intent to register a preference toward deceased organ donation, and whether such education fostered family discussions about organ donation. Fifteen studies were summarized from nine countries, of which six were randomized controlled trials. Most educational programs consisted of one or two classroom sessions. The methods employed in five studies received a high-quality rating. Educational programs increased knowledge in 10 studies, and attitudes in five studies, with variable effects on intent to affirmative registration. Seven studies reported success in promoting family discussions. Adolescent classroom education is a promising strategy to improve knowledge about deceased organ donation and appears to increase public support for donation. Subjecting these programs to additional evaluation will clarify their impact on affirmative donor registration and realized donations.

Worldwide variability in deceased organ donation registries.

The variability in deceased organ donation registries worldwide has received little attention. We considered all operating registries, where individual wishes about organ donation were recorded in a computerized database. We included registries which recorded an individual's decision to be a donor (donor registry), and registries which only recorded an individual's objection (non-donor registry). We collected information on 15 characteristics including history, design, use and number of registrants for 27 registries (68%). Most registries are nationally operated and government-owned. Registrations in five nations expire and require renewal. Some registries provide the option to make specific organ selections in the donation decision. Just over half of donor registries provide legally binding authorization to donation. In all national donor registries, except one, the proportion of adults (15+) registered is modest (<40%). These proportions can be even lower when only affirmative decisions are considered. One nation provides priority status on the transplant waiting list as an incentive to affirmative registration, while another nation makes registering a donation decision mandatory to obtain a driver's license. Registered objections in non-donor registries are rare (<0.5%). The variation in organ donor registries worldwide necessitates public discourse and quality improvement initiatives, to identify and support leading practices in registry use.