Dataset Information

Statistical analysis plan for a cluster-randomised trial assessing the effectiveness of implementation of a bedside evidence-based checklist for clinical management of brain-dead potential organ donors in intensive care units: DONORS (Donation Network to Optimise Organ Recovery Study).

ABSTRACT:

Background

The quality of clinical care of brain-dead potential organ donors may help reduce donor losses caused by irreversible or unreversed cardiac arrest and increase the number of organs donated. We sought to determine whether an evidence-based, goal-directed checklist for donor management in intensive care units (ICUs) can reduce donor losses to cardiac arrest.

Methods/design

The DONORS study is a multicentre, cluster-randomised controlled trial with a 1:1 allocation ratio designed to compare an intervention group (goal-directed checklist for brain-dead potential organ donor management) with a control group (standard ICU care). The primary outcome is loss of potential donors due to cardiac arrest. Secondary outcomes are the number of actual organ donors and the number of solid organs recovered per actual donor. Exploratory outcomes include the achievement of relevant clinical goals during the management of brain-dead potential organ donors. The present statistical analysis plan (SAP) describes all primary statistical procedures that will be used to evaluate the results and perform exploratory and sensitivity analyses of the trial.

Discussion

The SAP of the DONORS study aims to describe its analytic procedures, enhancing the transparency of the study. At the moment of SAP subsmission, 63 institutions have been randomised and were enrolling study participants. Thus, the analyses reported herein have been defined before the end of the study recruitment and database locking.

Trial registration

ClinicalTrials.gov, NCT03179020. Registered on 7 June 2017.

SUBMITTER: Giordani NE

PROVIDER: S-EPMC7298918 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Statistical analysis plan for a cluster-randomised trial assessing the effectiveness of implementation of a bedside evidence-based checklist for clinical management of brain-dead potential organ donors in intensive care units: DONORS (Donation Network to Optimise Organ Recovery Study).

Giordani Natalia Elis NE Robinson Caroline Cabral CC Westphal Glauco Adrieno GA Rosa Regis Goulart RG Sganzerla Daniel D Cavalcanti Alexandre Biasi AB Machado Flávia Ribeiro FR Azevedo Luciano Cesar Pontes LCP Bozza Fernando Augusto FA Teixeira Cassiano C de Andrade Joel J Franke Cristiano Augusto CA Guterres Cátia Moreira CM Madalena Itiana Cardoso IC Rohden Adriane Isabel AI da Silva Sabrina Souza SS Andrighetto Luiza Vitelo LV Rech Gabriela Soares GS Gimenes Bruna Dos Passos BDP Hammes Luciano Serpa LS Pontes Daniela Ferreira Salomão DFS Meade Maureen O MO Falavigna Maicon M

Trials 20200617 1

<h4>Background</h4>The quality of clinical care of brain-dead potential organ donors may help reduce donor losses caused by irreversible or unreversed cardiac arrest and increase the number of organs donated. We sought to determine whether an evidence-based, goal-directed checklist for donor management in intensive care units (ICUs) can reduce donor losses to cardiac arrest.<h4>Methods/design</h4>The DONORS study is a multicentre, cluster-randomised controlled trial with a 1:1 allocation ratio d ...[more]

PMID: 32552839

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Project description:ImportanceThe effectiveness of goal-directed care to reduce loss of brain-dead potential donors to cardiac arrest is unclear.ObjectiveTo evaluate the effectiveness of an evidence-based, goal-directed checklist in the clinical management of brain-dead potential donors in the intensive care unit (ICU).Design, setting, and participantsThe Donation Network to Optimize Organ Recovery Study (DONORS) was an open-label, parallel-group cluster randomized clinical trial in Brazil. Enrollment and follow-up were conducted from June 20, 2017, to November 30, 2019. Hospital ICUs that reported 10 or more brain deaths in the previous 2 years were included. Consecutive brain-dead potential donors in the ICU aged 14 to 90 years with a condition consistent with brain death after the first clinical examination were enrolled. Participants were randomized to either the intervention group or the control group. The intention-to-treat data analysis was conducted from June 15 to August 30, 2020.InterventionsHospital staff in the intervention group were instructed to administer to brain-dead potential donors in the intervention group an evidence-based checklist with 13 clinical goals and 14 corresponding actions to guide care, every 6 hours, from study enrollment to organ retrieval. The control group provided or received usual care.Main outcomes and measuresThe primary outcome was loss of brain-dead potential donors to cardiac arrest at the individual level. A prespecified sensitivity analysis assessed the effect of adherence to the checklist in the intervention group.ResultsAmong the 1771 brain-dead potential donors screened in 63 hospitals, 1535 were included. These patients included 673 males (59.2%) and had a median (IQR) age of 51 (36.3-62.0) years. The main cause of brain injury was stroke (877 [57.1%]), followed by trauma (485 [31.6%]). Of the 63 hospitals, 31 (49.2%) were assigned to the intervention group (743 [48.4%] brain-dead potential donors) and 32 (50.8%) to the control group (792 [51.6%] brain-dead potential donors). Seventy potential donors (9.4%) at intervention hospitals and 117 (14.8%) at control hospitals met the primary outcome (risk ratio [RR], 0.70; 95% CI, 0.46-1.08; P = .11). The primary outcome rate was lower in those with adherence higher than 79.0% than in the control group (5.3% vs 14.8%; RR, 0.41; 95% CI, 0.22-0.78; P = .006).Conclusions and relevanceThis cluster randomized clinical trial was inconclusive in determining whether the overall use of an evidence-based, goal-directed checklist reduced brain-dead potential donor loss to cardiac arrest. The findings suggest that use of such a checklist has limited effectiveness without adherence to the actions recommended in this checklist.Trial registrationClinicalTrials.gov Identifier: NCT03179020.

Project description:ObjectivesIn the United Kingdom, three people die every day awaiting an organ transplant. To address this, Scotland and England plan to follow Wales and introduce opt-out donor consent. However, emotional barriers, myths, and misconceptions may deter potential registrants. Our objectives were to estimate the number of people who plan to opt-out of the donor register and to test whether emotional barriers (e.g., medical mistrust) differentiated participants within this group. Finally, in an experimental manipulation, we tested whether intention to donate decreased by making emotional barriers more salient and increased following a widely used myth-busting intervention.DesignMixed between-within design.MethodsUK residents (n = 1,202) were asked whether they would choose opt-in, deemed consent, or opt-out/not sure if legislation changes to opt-out. Participants also completed measures of donor intentions at baseline, following a 12-item emotional barriers questionnaire and again, following a 9-item myth-busting intervention.ResultsFindings indicate that 66.1% of participants selected to opt-in to the donor register, 24.3% selected deemed consent, and 9.4% selected opt-out/not sure. Emotional barriers, notably fears surrounding bodily integrity, were significantly elevated in participants who selected opt-out/not sure. Increasing the salience of emotional barriers reduced donor intentions in the opt-out/not sure group. However, dispelling organ donation myths did not increase intention within this group.ConclusionsIf opt-out legislation is introduced in Scotland and England, approximately 10% of participants plan to opt-out or are not sure. Dispelling organ donation myths with facts may not be the best method of overcoming emotional barriers and increasing donor intentions for those planning to opt-out. Statement of contribution What is already known about this subject? In the United Kingdom, three people die every day waiting for an organ transplant. Although 90% of the UK population support organ donation, only 38% are registered donors. To address this, Scotland and England have recently proposed to introduce an opt-out system of donor consent. To date, limited research has investigated public attitudes and intentions regarding opt-out consent laws in Scotland and England. Emotional barriers (e.g., medical mistrust) are key factors that may deter potential registrants. However, no research has examined these barriers in relation to proposed opt-out consent laws. Myth-busting is widely used around the world as part of campaigns promoting organ donation. The NHS currently use a myth-busting feature on their webpage to dispel harmful myths about organ donation; however, there is limited evidence of the impact this has on intentions to become an organ donor. What does this study add? Approximately 10% of UK participants plan to opt-out or are unsure of their decision, if the law changes to opt-out. Emotional barriers, notably, bodily integrity fears, are significantly elevated in people who plan to opt-out. Increasing the salience of emotional barriers reduced donor intentions for people who plan to opt-out. A myth-busting intervention had no effect on donor intentions for people who plan to opt-out of the donor register.

Project description:Background and objectivesComprehensive evaluations are required to safeguard voluntarism and minimize harm to living kidney donors. This process is lengthy, invasive, and emotionally challenging, with up to one fifth of potential donors opting out. We aimed to describe donors' experiences of the evaluation process.Design, setting, participants, & measurementsWe conducted 14 focus groups involving 123 kidney donors who completed donation from three transplant centers (Australia and Canada). Transcripts were analyzed thematically.ResultsWe identified six themes reflecting donors' experiences of evaluation. The themes that related to perseverance included emotional investment (prioritizing the recipient's health, desperation for a normal life, protecting eligibility, shame of disappointing others, and overcoming opposition), undeterred by low risks (medical confidence and protection, worthwhile gamble, inherent invincibility, and normalizing risks), and mental preparation (avoiding regret, resolving decisional ambivalence, and managing expectations of recovery). The challenges included underlying fears for health (processing alarming information, unsettling uncertainty, and preoperative panic), system shortfalls (self-advocacy in driving the process, stressful urgency, inconsistent framing of safety, unnerving bodily scrutiny, questioning risk information, and draining finances); and lifestyle interference (living in limbo, onerous lifestyle disruption, and valuing flexibility).ConclusionsPrevious donors described an emotional investment in donating and determination to protect their eligibility, despite having concerns for their health, financial and lifestyle disruption, and opposition from their family or community. Our findings suggest the need to prepare donors for surgery and recovery, minimize anxiety and lifestyle burdens, ensure that donors feel comfortable expressing their fears and concerns, reduce unnecessary delays, and make explicit the responsibilities of donors in their assessment process.

Dataset Information

Statistical analysis plan for a cluster-randomised trial assessing the effectiveness of implementation of a bedside evidence-based checklist for clinical management of brain-dead potential organ donors in intensive care units: DONORS (Donation Network to Optimise Organ Recovery Study).

Background

Methods/design

Discussion

Trial registration

Publications

Statistical analysis plan for a cluster-randomised trial assessing the effectiveness of implementation of a bedside evidence-based checklist for clinical management of brain-dead potential organ donors in intensive care units: DONORS (Donation Network to Optimise Organ Recovery Study).

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