Testing the Feasibility of Sensor-Based Home Health Monitoring (TEC4Home) to Support the Convalescence of Patients With Heart Failure: Pre-Post Study.

BACKGROUND: Patients with heart failure (HF) can be affected by disabling symptoms and low quality of life. Furthermore, they may frequently need to visit the emergency department or be hospitalized due to their condition deteriorating. Home telemonitoring can play a role in tracking symptoms, reducing hospital visits, and improving quality of life. OBJECTIVE: Our objective was to conduct a feasibility study of a home health monitoring (HHM) solution for patients with HF in British Columbia, Canada, to prepare for conducting a randomized controlled trial. METHODS: Patients with HF were recruited from 3 urban hospitals and provided with HHM technology for 60 days of monitoring postdischarge. Participants were asked to monitor their weight, blood pressure, and heart rate and to answer symptomology questions via Bluetooth sensors and a tablet computer each day. A monitoring nurse received this data and monitored the patient's condition. In our evaluation, the primary outcome was the combination of unscheduled emergency department revisits of discharged participants or death within 90 days. Secondary outcomes included 90-day hospital readmissions, patient quality of life (as measured by Veterans Rand 12-Item Health Survey and Kansas City Cardiomyopathy Scale), self-efficacy (as measured by European Heart Failure Self-Care Behaviour Scale 9), end-user experience, and health system cost-effectiveness including cost reduction and hospital bed capacity. In this feasibility study, we also tested the recruitment strategy, clinical protocols, evaluation framework, and data collection methods. RESULTS: Seventy participants were enrolled into this trial. Participant engagement to monitoring was measured at 94% (N=70; ie, data submitted 56/60 days on average). Our evaluation framework allowed us to collect sound data, which also showed encouraging trends: a 79% reduction of emergency department revisits post monitoring, an 87% reduction in hospital readmissions, and a 60% reduction in the median hospital length of stay (n=36). Cost of hospitalization for participants decreased by 71%, and emergency department visit costs decreased by 58% (n=30). Overall health system costs for our participants showed a 56% reduction post monitoring (n=30). HF-specific quality of life (Kansas City Cardiomyopathy Scale) scores showed a significant increase of 101% (n=35) post monitoring (P<.001). General quality of life (Veterans Rand 12-Item Health Survey) improved by 19% (n=35) on the mental component score (P<.001) and 19% (n=35) on the physical component score (P=.02). Self-efficacy improved by 6% (n=35). Interviews with participants revealed that they were satisfied overall with the monitoring program and its usability, and participants reported being more engaged, educated, and involved in their self-management. CONCLUSIONS: Results from this small-sample feasibility study suggested that our HHM intervention can be beneficial in supporting patients post discharge. Additionally, key insights from the trial allowed us to refine our methods and procedures, such as shifting our recruitment methods to in-patient wards and increasing our scope of data collection. Although these findings are promising, a more rigorous trial design is required to test the true efficacy of the intervention. The results from this feasibility trial will inform our next step as we proceed with a randomized controlled trial across British Columbia. TRIAL REGISTRATION: ClinicalTrials.gov NCT03439384; https://clinicaltrials.gov/ct2/show/NCT03439384.

Development of the Canadian COVID-19 Emergency Department Rapid Response Network population-based registry: a methodology study.

BACKGROUND: Emergency physicians lack high-quality evidence for many diagnostic and treatment decisions made for patients with suspected or confirmed coronavirus disease 2019 (COVID-19). Our objective is to describe the methods used to collect and ensure the data quality of a multicentre registry of patients presenting to the emergency department with suspected or confirmed COVID-19. METHODS: This methodology study describes a population-based registry that has been enrolling consecutive patients presenting to the emergency department with suspected or confirmed COVID-19 since Mar. 1, 2020. Most data are collected from retrospective chart review. Phone follow-up with patients at 30 days captures the World Health Organization clinical improvement scale and contextual, social and cultural variables. Phone follow-up also captures patient-reported quality of life using the Veterans Rand 12-Item Health Survey at 30 days, 60 days, 6 months and 12 months. Fifty participating emergency departments from 8 provinces in Canada currently enrol patients into the registry. INTERPRETATION: Data from the registry of the Canadian COVID-19 Emergency Department Rapid Response Network will be used to derive and validate clinical decision rules to inform clinical decision-making, describe the natural history of the disease, evaluate COVID-19 diagnostic tests and establish the real-world effectiveness of treatments and vaccines, including in populations that are excluded or underrepresented in clinical trials. This registry has the potential to generate scientific evidence to inform our pandemic response, and to serve as a model for the rapid implementation of population-based data collection protocols for future public health emergencies. TRIAL REGISTRATION: Clinicaltrials.gov, no. NCT04702945.

Top ten priorities for anesthesia and perioperative research: a report from the Canadian Anesthesia Research Priority Setting Partnership.

PURPOSE: The purpose of the Canadian Anesthesia Research Priority Setting Partnership (CAR PSP) was to identify a top ten list of shared priorities for research in anesthesia and perioperative care in Canada. METHODS: We used the methods of the James Lind Alliance to involve patients, caregivers, healthcare professionals, and researchers in determining the research priorities in Canada. In a first survey, participants submitted questions that they want research to answer about anesthesia and perioperative care. We summarized those responses into a longlist of questions. We reviewed the literature to see if any of those questions were already answered. In a second survey, participants chose up to ten questions from the longlist that they thought were most important to be answered with research. From that list, the highest ranking questions were discussed and assigned a final rank at an in-person workshop. RESULTS: A total of 254 participants submitted 574 research suggestions that were then summarized into 49 questions. Those questions were checked against the literature to be sure they were not already adequately addressed, and in a second survey of those 49 questions, participants chose up to 10 that they thought were most important. A total of 233 participants submitted their priorities, which were then used to choose 24 questions for discussion at the final workshop. At the final workshop, 22 participants agreed on a top ten list of priorities. CONCLUSION: The CAR PSP top ten priorities reflect a wide variety of priorities captured by a broad spectrum of Canadians who receive and provide anesthesia care. The priorities are a tool to initiate and guide patient-oriented research in anesthesia and perioperative care.

RéSUMé: OBJECTIF: L'objectif du Partenariat canadien pour l'établissement des priorités de la recherche en anesthésie (CAR-PSP) était d'établir une liste des dix principales priorités pour la recherche sur les soins anesthésiques et périopératoires au Canada. MéTHODES: Nous avons utilisé la méthodologie de la James Lind Alliance pour impliquer des patients, des aidants, des professionnels de la santé et des chercheurs afin de déterminer quelles étaient les priorités en matière de recherche au Canada. Dans une première enquête, les participants ont envoyé des questions sur les soins anesthésiques et périopératoires auxquelles ils voulaient que la recherche réponde. Nous avons résumé ces envois par une liste exhaustive de questions. Nous avons passé en revue les publications pour voir s'il existait déjà des réponses à ces questions. Dans une deuxième étude, les participants ont choisi dans la liste jusqu'à dix questions qui leur semblaient les plus importantes et pour lesquelles la recherche devrait fournir des réponses. À partir de cette liste, les questions les mieux classées ont été discutées et un classement définitif leur a été attribué au cours d'un atelier où tous les participants étaient présents en personne. RéSULTATS: Au total, 254 participants ont envoyé 574 suggestions de recherche qui ont été résumées en 49 questions. La littérature a été examinée pour s'assurer que ces questions n'avaient pas déjà reçu des réponses adéquates, et dans une seconde étude, les participants ont choisi jusqu'à 10 questions qu'ils jugeaient les plus importantes parmi ces 49 questions. Au total, 233 participants ont communiqué leurs priorités qui ont alors servi à choisir 24 questions ouvertes pour la discussion dans un atelier final. Dans cet atelier, 22 participants se sont mis d'accord sur une liste des dix principales priorités. CONCLUSION: Les dix principales priorités du CAR-PSP sont le reflet d'un grand éventail de priorités venant de Canadiens de tous horizons qui reçoivent ou fournissent des soins d'anesthésie. Ces priorités sont un outil permettant d'entamer et de guider une recherche axée sur le patient dans le domaine des soins anesthésiques et périopératoires.

What matters most to patients about primary healthcare: mixed-methods patient priority setting exercises within the PREFeR (PRioritiEs For Research) project.

OBJECTIVES: To identify patient-generated priority topics for future primary care research in British Columbia (BC), Canada within a diverse patient population. DESIGN: Mixed-methods priority setting exercises framed by the dialogue model, using the nominal group technique (rank-ordered scoring) and province-wide online surveys capturing importance ratings of the top 10 primary healthcare topics from patients and primary care providers. SETTING: BC, Canada. PARTICIPANTS: Topic identification was completed by 10 patient partners (7 female, 3 male) from the BC Primary Health Care Research Network Patient Advisory; online surveys were completed by 464 patients and 173 primary care providers. RESULTS: The 10 members recruited to the patient advisory provided over 80 experiences of what stood out for them in BC primary care, which were grouped thematically into 18 topics, 10 of which were retained in province-wide surveys. Top-rated survey topics for both patients (n=464) and providers (n=173) included being unable to find a regular family doctor/other primary healthcare provider, support for living with chronic conditions, mental health resources and information sharing, including electronic medical records. However, all 10 topics were rated important, on average, by both groups. CONCLUSIONS: The current project activities demonstrate the feasibility of including patients in priority setting exercises for primary healthcare in general, rather than focusing on a condition-specific population or disease area. There was considerable overlap between patient-generated topics and topics previously identified by other stakeholders, but patients identified two additional topics (mental health resources, improve and strengthen patient-provider communication). More similarities than differences in topic importance between patients and providers emerged in the online surveys. The project activities that follow (rapid literature reviews, multistakeholder dialogue) will highlight under-researched topics and inform the development of specific research questions.

Co-building a patient-oriented research curriculum in Canada.

PLAIN ENGLISH SUMMARY: Foundations in Patient-Oriented Research is a course designed and piloted in Canada to help patients, researchers, health care professionals and health system decision-makers gain an introductory understanding of patient-oriented research, the research enterprise, and how to work in a team. The course curriculum was co-developed by a diverse group of people with different lived experiences and relevant expertise. The course is meant to be delivered in a 'co-learning format' with classes comprised of all the above stakeholder groups learning together. The purpose of this study was to explore the experiences of the project leaders, developers, facilitators and patient co-facilitators who were involved in the process of co-developing, piloting and revising the curriculum.Our findings suggest that co-developing a patient-oriented research curriculum increases its quality, uptake and credibility. The co-development process not only resulted in training that benefited the target learners, but it provided valuable learning experiences about patient-oriented research for the project leaders, developers, facilitators and patient co-facilitators. These findings and the resulting recommendations may provide guidance for other learning and development groups wishing to undertake a similar project. ABSTRACT: Background Foundations in Patient-Oriented Research is a course designed and piloted in Canada to build mutually beneficial relationships for conducting patient-oriented research by ensuring that relevant stakeholders - patients, researchers, health care professionals and health system decision-makers - have a common foundational understanding of patient-oriented research, the research enterprise, and team dynamics. The curriculum was co-developed by a group of patients, researchers, patient engagement experts and curriculum development experts and involved consultations with broader groups of the relevant stakeholders mentioned above. It was designed to be delivered in a 'co-learning format' with classes comprised of all stakeholder groups learning together. The purpose of this study was to explore the experiences of individuals involved in the process of co-developing, piloting and revising Foundations in Patient-Oriented Research. Methods An embedded case study was conducted with individuals who were involved in the co-development, pilot and revision of Foundations in Patient-Oriented Research. These individuals took on different roles during the curriculum development process, including project co-lead, developer, facilitator, and patient co-facilitator. The constant comparison method was used to inductively develop themes from the two focus group sessions. Results Discussions from the focus groups revealed the value of co-building the content, co-facilitating the course sessions, and the importance of the co-learning format. The training itself was perceived as valuable and the systematic approach to co-development was perceived as a success. Several barriers were identified, including the amount of resources, time and commitment required to complete the project. There was a notable tension between maintaining the integrity of the content and having the freedom to adapt it to local contexts. Over the course of the project, the project co-leads, developers and facilitators found that their own understanding of patient-oriented research deepened. Conclusions The findings of this study suggest that co-developing a patient-oriented research curriculum increases its quality, uptake and credibility. The co-development process not only resulted in training that benefited the target learners, but also built capacity for patient-oriented research within the project co-leads, developers, facilitators and patient co-facilitators. Our findings and recommendations may provide guidance for other learning and development groups wishing to undertake a similar project.

Recommendations for patient engagement in patient-oriented emergency medicine research.

OBJECTIVE: To make pragmatic recommendations on best practices for the engagement of patients in emergency medicine (EM) research. METHODS: We created a panel of expert Canadian EM researchers, physicians, and a patient partner to develop our recommendations. We used mixed methods consisting of 1) a literature review; 2) a survey of Canadian EM researchers; 3) qualitative interviews with key informants; and 4) feedback during the 2017 Canadian Association of Emergency Physicians (CAEP) Academic Symposium. RESULTS: We synthesized our literature review into categories including identification and engagement, patients' roles, perceived benefits, harms, and barriers to patient engagement; 40/75 (53% response rate) invited researchers completed our survey. Among respondents, 58% had engaged patients in research, and 83% intended to engage patients in future research. However, 95% stated that they need further guidance to engage patients. Our qualitative interviews revealed barriers to patient engagement, including the need for training and patient partner recruitment.Our panel recommends 1) an overarching positive recommendation to support patient engagement in EM research; 2) seven policy-level recommendations for CAEP to support the creation of a national patient council, to develop, adopt and adapt training material, guidelines, and tools for patient engagement, and to support increased patient engagement in EM research; and 3) nine pragmatic recommendations about engaging patients in the preparatory, execution, and translational phases of EM research. CONCLUSION: Patient engagement can improve EM research by helping researchers select meaningful outcomes, increase social acceptability of studies, and design knowledge translation strategies that target patients' needs.

Engaging patients as partners in health research: Lessons from BC, Canada.

Canada is seeing increased interest in engaging patients in health research, recognizing the potential to improve its relevance and quality. The momentum is promising, but there may be a tendency to ignore the challenges inherent when lay people and professionals collaborate. We address some of these challenges as they relate to recruitment, training, and support for patients at the British Columbia (BC) Support for People and Patient-Oriented Research Unit, part of Canada's Strategy for Patient-Oriented Research. A retrospective review of a telehealth project demonstrates that, as well as the practical elements of recruitment, training, and support, attention must be paid to issues of credibility, legitimacy, and power when engaging patients. We propose that all patient-oriented research projects would benefit from using a similar framework to guide patient engagement planning and implementation, helping to anticipate and mitigate challenges from the outset. Projects would ideally also include the study of patient engagement methods, to add to this important body of knowledge.

Colleen's story: reflections on the concept of "patient and family centered care".

As a patient who has also been a family caregiver, I would like to offer my reflections on the concept of "patient and family centered care." How is it defined from a patient perspective? Why is it important? In what circumstances is it evident? And where is it lacking? I would like to leave the reader with a list of relatively small but, in my experience, powerful things that health care workers can do today to improve the patient and family experience.

Results of phase II levetiracetam trial following acute head injury in children at risk for posttraumatic epilepsy.

Posttraumatic seizures develop in up to 20% of children following severe traumatic brain injury (TBI). Children ages 6-17 years with one or more risk factors for the development of posttraumatic epilepsy, including presence of intracranial hemorrhage, depressed skull fracture, penetrating injury, or occurrence of posttraumatic seizure were recruited into this phase II study. Treatment subjects received levetiracetam 55 mg/kg/day, b.i.d., for 30 days, starting within 8 h postinjury. The recruitment goal was 20 treated patients. Twenty patients who presented within 8-24 h post-TBI and otherwise met eligibility criteria were recruited for observation. Follow-up was for 2 years. Forty-five patients screened within 8 h of head injury met eligibility criteria and 20 were recruited into the treatment arm. The most common risk factor present for pediatric inclusion following TBI was an immediate seizure. Medication compliance was 95%. No patients died; 19 of 20 treatment patients were retained and one observation patient was lost to follow-up. The most common severe adverse events in treatment subjects were headache, fatigue, drowsiness, and irritability. There was no higher incidence of infection, mood changes, or behavior problems among treatment subjects compared to observation subjects. Only 1 (2.5%) of 40 subjects developed posttraumatic epilepsy (defined as seizures >7 days after trauma). This study demonstrates the feasibility of a pediatric posttraumatic epilepsy prevention study in an at-risk traumatic brain injury population. Levetiracetam was safe and well tolerated in this population. This study sets the stage for implementation of a prospective study to prevent posttraumatic epilepsy in an at-risk population.

Partial Pyridoxine Responsiveness in PNPO Deficiency.

OBJECTIVE: Autosomal-recessive pyridox(am)ine phosphate oxidase (PNPO) deficiency causes pyridoxal-5-phosphate (PLP)-dependent epilepsy. We describe partial PNPO deficiency with a transient response to pyridoxine (B6). METHODS: CSF neurotransmitter metabolites, PLP, and amino acids were analyzed while the patient was receiving pyridoxine. PNPO gene sequencing was performed by standard techniques. RESULTS: A full-term 3,220 g male with refractory neonatal seizures became seizure free for 6 weeks on pyridoxine (B6). Breakthrough seizures followed. These stopped upon the first dose of PLP although episodes occurred as a dose became due. An unidentified peak was detected on the chromatographic system used to measure CSF PLP. PNPO gene sequencing identified a homozygous mutation in a highly conserved area in exon 3: c.352G>A p.G118R, predicting substitution of arginine for glycine. At age 28 months the child has hypotonia and developmental delay, both mild in severity. CONCLUSIONS: Transient pyridoxine responsiveness may be seen in partial PNPO deficiency. A CSF metabolite peak, likely pyridoxine phosphate, is identifiable in patients with PNPO deficiency who are taking supplemental pyridoxine. Partial B6 responsiveness is an indication for possible PNPO deficiency and trial of PLP.