Public perception of participation in low-risk clinical trials in critical care using waived consent: a Canadian national survey.

PURPOSE: The acceptability of waiver of consent for participation in clinical research in intensive care unit (ICU) settings is uncertain. We sought to survey the Canadian public to assess levels of support, comfort, and acceptability for waived consent for low-risk clinical trials. METHODS: We performed a prospective cross-sectional survey of the Canadian public aged 18 yr or older. The survey was conducted by Ipsos between 19 and 23 November 2020. The survey content was derived from a literature review and in consultation with a patient and family partnership committee. The survey focused on attitudes and beliefs on waived consent for participation in low-risk clinical trials in ICU settings. The survey contained 35 items focused on sociodemographics, general health status, participation in medical research, and levels of support and comfort with research and with waived consent. The survey used a case study of a low-risk clinical trial intervention in ICU patients. Analysis was descriptive. RESULTS: We included 2,000 participants, 38% of whom reported experience with ICU and 16% with medical research. Participation in medical research was more common among those with postsecondary education, those with chronic disease, and those who were employed in health care. Most (80%) would support a model of waived consent for low-risk clinical trials, citing medical benefits (36%) and low perceived risk (34%). Most (77%) were comfortable with personally participating in a low-risk clinical trial. Most (80%) believed waived consent approaches were acceptable. Half (52%) believed the waived consent process should provide information about the research and include the option of opting out. When asked whether participants should always give full informed consent, regardless of the practicality or level of risk, 74% and 72% agreed, respectively. CONCLUSIONS: There is public support for models of waived consent for participation in low-risk pragmatic clinical trials in ICU settings in Canada; however, this is not universal. This information can inform and guide education, ethics, policy, and legal discussion on consent models.

RéSUMé: OBJECTIF: L'acceptabilité de la renonciation au consentement pour la participation à la recherche clinique à l'unité de soins intensifs (USI) est incertaine. Nous avons cherché à sonder la population canadienne afin d'évaluer les niveaux de soutien, de confort et d'acceptabilité de la renonciation au consentement pour les études cliniques à faible risque. MéTHODE: Nous avons réalisé un sondage transversal prospectif auprès de la population canadienne âgée de 18 ans et plus. Le sondage a été réalisé par Ipsos entre le 19 et le 23 novembre 2020. Le contenu du sondage a été élaboré à partir d'une revue de la littérature et en consultation avec un comité de partenariat composé de patient·es et de familles. Le sondage portait sur les attitudes et les croyances à l'égard de la renonciation au consentement pour participer à des études cliniques à faible risque dans les unités de soins intensifs. Le sondage comportait 35 questions axées sur les données sociodémographiques, l'état de santé général, la participation à la recherche médicale et les niveaux de soutien et de confort à l'égard de la recherche et de la renonciation au consentement. Le sondage s'est appuyé sur une étude de cas d'une intervention d'étude clinique à faible risque chez des patient·es des soins intensifs. L'analyse était descriptive. RéSULTATS: Nous avons inclus 2000 personnes, dont 38 % ont déclaré avoir eu des expériences en soins intensifs et 16 % en recherche médicale. La participation à la recherche médicale était plus fréquente chez les personnes ayant fait des études postsecondaires, celles atteintes de maladies chroniques et celles qui travaillaient dans le domaine des soins de santé. La plupart d'entre elles (80 %) appuieraient un modèle de renonciation au consentement pour les études cliniques à faible risque, citant les avantages médicaux (36 %) et le faible risque perçu (34 %). La majorité des personnes répondantes (77 %) étaient à l'aise à l'idée de participer personnellement à une étude clinique à faible risque. La plupart d'entre elles (80 %) croyaient que les approches fondées sur la renonciation au consentement étaient acceptables. La moitié (52 %) estimaient que le processus de renonciation au consentement devrait fournir des renseignements sur la recherche et inclure la possibilité de se retirer. Lorsqu'on leur a demandé si les participant·es devraient toujours donner un consentement éclairé complet, quel que soit l'aspect pratique ou le niveau de risque, 74 % et 72 % ont répondu par l'affirmative, respectivement. CONCLUSION: Il y a un appui public pour les modèles de renonciation au consentement quant à la participation à des études cliniques pragmatiques à faible risque dans les unités de soins intensifs au Canada; cet appui n'est toutefois pas universel. Ces renseignements peuvent éclairer et orienter l'éducation, l'éthique, les politiques et les discussions juridiques sur les modèles de consentement.

"I think there has to be a mutual respect for there to be value": Evaluating patient engagement in a national clinical trial on de-implementation of low value care.

BACKGROUND: The evaluation of patient engagement in research is understudied and under-reported, making it difficult to know what engagement strategies work best and when. We provide the results of an evaluation of patient engagement in a large Canadian research program focused on the de-implementation of low-value care. We aimed to evaluate the experience and impact of patient engagement in the study. METHODS: An online cross-sectional survey was administered using Microsoft Forms to (1) researchers and study staff and (2) patient partners. The survey was developed following iterative reviews by the project's patient partnership council and evaluation committee. Survey content areas included opinions on patient engagement to date, including challenges to engagement and suggestions for improvement. Patient partners also evaluated the partnership council. Descriptive statistics including counts and percentages described Likert scale survey items, while open comments were analyzed using descriptive content analysis. RESULTS: The survey response rate was 46% (17/37). There were positive attitudes about the value of patient engagement in this project. There was also a high degree of willingness to be involved with patient engagement in future projects, whether as a patient partner or as a researcher including patients on the research team. Most patient partners felt their contributions to the project were valued by researchers and study research staff. Open comments revealed that a co-design approach and full inclusion on the research team were integral to demonstrating the value of patient partner input. Areas for improvement included more frequent and ongoing communication among all team members, as well as earlier training about patient engagement, particularly addressing role expectations and role clarity. CONCLUSIONS: Our data revealed that despite some challenges, team members recognized the value of patient engagement in research and agreed project decisions had been impacted by patient partner input. Ongoing communication was highlighted as an area for improvement, as well as earlier training and ongoing support for all team members, but particularly researchers and study staff. In response to evaluation data, the team has reinstated a quarterly newsletter and plans to use specific patient engagement planning templates across study sites for all project activities. These tools should help make expectations clear for all team members and contribute to a positive patient engagement experience. Findings can inform patient engagement planning and evaluation for other health research projects.

Evaluating patient engagement in research is often not done or not reported, making it hard to know what engagement strategies work best and when. Here, we provide the results of an evaluation of patient engagement in a Canadian Institutes for Health Research (CIHR) Strategy for Patient Oriented Research (SPOR) Innovative Clinical Trial Multi-Year Grant. The project focuses on strategies to reduce two low-value care practices (pre-operative testing in low-risk day surgery and imaging for low back pain). An online survey was sent to project researchers, study staff and patient partners to get their opinions on the patient engagement in the project. Generally, there were positive attitudes about the value of patient engagement in the project. Both patient partners and research study staff were very willing to be involved with patient engagement in future projects. Most patient partners felt their contributions to the project were valued by researchers and study research staff. An important part of showing the value of patient partners was working together to design the project and making sure that the patient partners were considered full members of the research team. Areas for improvement included better communication among all team members and earlier training about patient engagement with a focus on patient roles and expectations. The results from this survey will be used to improve the patient engagement in this project but will also help patient engagement planning and evaluation for other health research projects.

Beyond guideline knowledge: a theory-based qualitative study of low-value preoperative testing.

BACKGROUND: Choosing Wisely Canada and most major anesthesia and preoperative guidelines recommend against obtaining preoperative tests before low-risk procedures. However, these recommendations alone have not reduced low-value test ordering. In this study, the theoretical domains framework (TDF) was used to understand the drivers of preoperative electrocardiogram (ECG) and chest X-ray (CXR) ordering for patients undergoing low-risk surgery ('low-value preoperative testing') among anesthesiologists, internal medicine specialists, nurses, and surgeons. METHODS: Using snowball sampling, preoperative clinicians working in a single health system in Canada were recruited for semi-structured interviews about low-value preoperative testing. The interview guide was developed using the TDF to identify the factors that influence preoperative ECG and CXR ordering. Interview content was deductively coded using TDF domains and specific beliefs were identified by grouping similar utterances. Domain relevance was established based on belief statement frequency, presence of conflicting beliefs, and perceived influence over preoperative test ordering practices. RESULTS: Sixteen clinicians (7 anesthesiologists, 4 internists, 1 nurse, and 4 surgeons) participated. Eight of the 12 TDF domains were identified as the drivers of preoperative test ordering. While most participants agreed that the guidelines were helpful, they also expressed distrust in the evidence behind them (knowledge). Both a lack of clarity about the responsibilities of the specialties involved in the preoperative process and the ease by which any clinician could order, but not cancel tests, were drivers of low-value preoperative test ordering (social/professional role and identity, social influences, belief about capabilities). Additionally, low-value tests could also be ordered by nurses or the surgeon and may be completed before the anesthesia or internal medicine preoperative assessment appointment (environmental context and resources, beliefs about capabilities). Finally, while participants agreed that they did not intend to routinely order low-value tests and understood that these would not benefit patient outcomes, they also reported ordering tests to prevent surgery cancellations and problems during surgery (motivation and goals, beliefs about consequences, social influences). CONCLUSIONS: We identified key factors that anesthesiologists, internists, nurses, and surgeons believe influence preoperative test ordering for patients undergoing low-risk surgeries. These beliefs highlight the need to shift away from knowledge-based interventions and focus instead on understanding local drivers of behaviour and target change at the individual, team, and institutional levels.

Patient-identified priorities for successful partnerships in patient-oriented research.

Albertans4HealthResearch, supported by the Alberta Strategy for Patient-Oriented Research Patient Engagement Team, hosted a virtual round table discussion to develop a list of considerations for successful partnerships in patient-oriented research. The group, which consists of active patient partners across the Canadian province of Alberta and some research staff engaged in patient-oriented research, considered advice for academic researchers on how to best partner with patients and community members on health research projects. The group identified four main themes, aligned with the national strategy for patient-oriented research (SPOR) patient engagement framework, highlighting important considerations for researchers from the patient perspective, providing practical ways to implement SPOR's key principles: inclusiveness, support, mutual respect, and co-building. This commentary considers the process behind this engagement exercise and offers advice directly from active patient research partners on how to fulfill the operational patient engagement mandate. Academic research teams can use this guidance when considering how to work together with patient partners and community members.

Albertans4HealthResearch, supported by the Alberta Strategy for Patient-Oriented Research (AbSPORU) Patient Engagement Team, hosted a virtual round table discussion to develop a list of considerations for successful partnerships in patient-oriented research. The group, which consists of active patient partners across the Canadian province of Alberta and some research staff engaged in patient-oriented research, considered advice for academic researchers on how to best partner with patients and community members on health research projects. The group identified four main themes, aligned with the national Strategy for Patient-Oriented Research (SPOR) Patient Engagement Framework, highlighting important considerations for researchers from the patient perspective, providing practical ways to implement SPOR's key principles: inclusiveness, support, mutual respect, and co-building. This commentary considers the process behind this engagement exercise and offers advice directly from active patient research partners on how to fulfill the operational patient engagement mandate. Academic research teams can use this guidance when considering how to work together with patient partners and community members.