scholarly journals Pragmatic trial evaluating the effectiveness of a patient navigator to decrease emergency room utilisation in transition age youth with chronic conditions: the Transition Navigator Trial protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e034309
Author(s):  
Susan Samuel ◽  
Gina Dimitropoulos ◽  
Kyleigh Schraeder ◽  
Scott Klarenbach ◽  
Alberto Nettel-Aguirre ◽  
...  
Keyword(s):  
Cost Analysis ◽  
Emergency Room ◽  
Research Ethics ◽  
Health Research ◽  
Urgent Care ◽  
Patient Navigator ◽  
Adult Care ◽  
Healthcare Needs ◽  
Research Ethics Board ◽  
The University

IntroductionTransition to adult care is a challenging and complex process for youth with special healthcare needs. We aim to compare effectiveness of a patient navigator service in reducing emergency room (ER) use among adolescents with chronic health conditions transitioning to adult care.Methods and analysisPragmatic randomised controlled trial parallel group design comparing ER visit rates between patients with access to a personalised navigator intervention compared with usual care. Unit of randomisation is the patient. Treatment assignment will not be blinded. Embedded qualitative study to understand navigator’s role and cost analysis attributable to the intervention will be performed. Patients aged 16–21 years, followed within a chronic disease clinic, expected to be transferred to adult care within 12 months and residing in Alberta during study period will be recruited from three tertiary care paediatric hospitals. Sample size will be 300 in each arm. Navigator intervention over 24 months is designed to assist participants in four domains: transition preparation, health system brokering, socioeconomic determinants of health and self-management. Primary outcome is ER visit rate during observation period. Secondary outcomes are ambulatory and inpatient care utilisation measures, as well as Transition Readiness Assessment Questionnaire score, and Short-Form Health Survey 12 (SF-12) score at 6 and 18 months post-randomisation. Poisson regression will compare rates of ER/urgent care visits between navigator and control participants, using intention to treat principle. Cost analysis of the intervention will be conducted. Thematic analysis will be used to identify perceptions of stakeholders regarding the role of navigators.Ethics and disseminationEthics approval was obtained from the University of Calgary Conjoint Health Research Ethics Board (REB #162561) and the University of Alberta Health Research Ethics Board (Pro00077325). Our team is composed of diverse stakeholders who are committed to improving transition of care who will assist with dissemination of results.Trial registration numberNCT03342495.

scholarly journals Problems in Coordinating and Accessing Primary Care for Attached and Unattached Patients Exacerbated During the COVID-19 Pandemic Year (the PUPPY Study): Protocol for a Longitudinal Mixed Methods Study (Preprint)

2021 ◽  
Author(s):  
Emily Gard Marshall ◽  
Mylaine Breton ◽  
Benoit Cossette ◽  
Jennifer Isenor ◽  
Maria Mathews ◽  
...  
Keyword(s):  
Primary Care ◽  
Mixed Methods ◽  
Nova Scotia ◽  
Research Ethics ◽  
Health Research ◽  
Health Sciences ◽  
Mixed Methods Study ◽  
Care Practice ◽  
Research Ethics Board ◽  
Unattached Patients

BACKGROUND The COVID-19 pandemic has significantly disrupted primary care in Canada, with many walk-in clinics and family practices initially closing or being perceived as inaccessible; pharmacies remaining open with restrictions on patient interactions; rapid uptake of virtual care; and reduced referrals for lab tests, diagnostics, and specialist care. OBJECTIVE The PUPPY Study (Problems in Coordinating and Accessing Primary Care for Attached and Unattached Patients Exacerbated During the COVID-19 Pandemic Year) seeks to understand the impact of the COVID-19 pandemic across the quadruple aims of primary care, with particular focus on the effects on patients without attachment to a regular provider and those with chronic health conditions. METHODS The PUPPY study builds on an existing research program exploring patients’ access and attachment to a primary care practice, pivoted to adapt to the emerging COVID-19 context. We intend to undertake a longitudinal mixed methods study to understand critical gaps in primary care access and coordination, as well as compare prepandemic and postpandemic data across 3 Canadian provinces (Quebec, Ontario, and Nova Scotia). Multiple data sources will be used such as a policy review; qualitative interviews with primary care policymakers, providers (ie, family physicians, nurse practitioners, and pharmacists), and patients (N=120); and medication prescriptions and health care billing data. RESULTS This study has received funding by the Canadian Institutes of Health Research COVID-19 Rapid Funding Opportunity Grant. Ethical approval to conduct this study was granted in Ontario (Queens Health Sciences & Affiliated Teaching Hospitals Research Ethics Board, file 6028052; Western University Health Sciences Research Ethics Board, project 116591; University of Toronto Health Sciences Research Ethics Board, protocol 40335) in November 2020, Québec (Centre intégré universitaire de santé et de services sociaux de l'Estrie, project 2020-3446) in December 2020, and Nova Scotia (Nova Scotia Health Research Ethics Board, file 1024979) in August 2020. CONCLUSIONS To our knowledge, this is the first study of its kind to explore the effects of the COVID-19 pandemic on primary care systems, with particular focus on the issues of patient’s attachment and access to primary care. Through a multistakeholder, cross-jurisdictional approach, the findings of the PUPPY study will inform the strengthening of primary care during and beyond the COVID-19 pandemic, as well as have implications for future policy and practice. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/29984

scholarly journals Assessing training needs in health research ethics: a case study from the University of Zambia School of Medicine

2020 ◽  
Vol 31 (1) ◽  
pp. 155-163
Author(s):  
Gershom Chongwe ◽  
Bornwell Sikateyo ◽  
Linda Kampata ◽  
Joseph Ali ◽  
Kristina Hallez ◽  
...  
Keyword(s):  
Research Ethics ◽  
Health Research ◽  
Training Needs ◽  
School Of Medicine ◽  
The University

scholarly journals Study protocol for a multicentre, prospective cohort study of the association of angiotensin II type 1 receptor blockers on outcomes of coronavirus infection

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e040768
Author(s):  
James A. Russell ◽  
John C Marshall ◽  
Arthur Slutsky ◽  
Srinivas Murthy ◽  
Dave Sweet ◽  
...  
Keyword(s):  
Cohort Study ◽  
Angiotensin Ii ◽  
Research Ethics ◽  
Health Research ◽  
Primary Outcome ◽  
Health Sciences ◽  
Ordinal Scale ◽  
Receptor Blockers ◽  
Research Ethics Board

IntroductionThe COVID-19 epidemic grows and there are clinical trials of antivirals. There is an opportunity to complement these trials with investigation of angiotensin II type 1 receptor blockers (ARBs) because an ARB (losartan) was effective in murine influenza pneumonia.Methods and analysisOur innovative design includes: ARBs; alignment with the WHO Ordinal Scale (primary endpoint) to align with other COVID-19 trials; joint longitudinal analysis; and predictive biomarkers (angiotensins I, 1–7, II and ACE1 and ACE2). Our hypothesis is: ARBs decrease the need for hospitalisation, severity (need for ventilation, vasopressors, extracorporeal membrane oxygenation or renal replacement therapy) or mortality of hospitalised COVID-19 infected adults. Our two-pronged multicentre pragmatic observational cohort study examines safety and effectiveness of ARBs in (1) hospitalised adult patients with COVID-19 and (2) out-patients already on or not on ARBs. The primary outcome will be evaluated by ordinal logistic regression and main secondary outcomes by both joint longitudinal modelling analyses. We will compare rates of hospitalisation of ARB-exposed versus not ARB-exposed patients. We will also determine whether continuing ARBs or not decreases the primary outcome. Based on published COVID-19 cohorts, assuming 15% of patients are ARB-exposed, a total sample size of 497 patients can detect a proportional OR of 0.5 (alpha=0.05, 80% power) comparing WHO scale of ARB-exposed versus non-ARB-exposed patients.Ethics and disseminationThis study has core institution approval (UBC Providence Healthcare Research Ethics Board) and site institution approvals (Health Research Ethics Board, University of Alberta; Comite d’etique de la recerche, CHU Sainte Justine (for McGill University and University of Sherbrook); Conjoint Health Research Ethics Board, University of Calgary; Queen’s University Health Sciences & Affiliated Hospitals Research Ethics Board; Research Ethics Board, Sunnybrook Health Sciences Centre; Veritas Independent Research Board (for Humber River Hospital); Mount Sinai Hospital Research Ethics Board; Unity Health Toronto Research Ethics Board, St. Michael’s Hospital). Results will be disseminated by peer-review publication and social media releases.Trial registration numberNCT04510623

scholarly journals 545 A phase 2 study of retifanlimab in patients with advanced or metastatic merkel cell carcinoma (MCC) (POD1UM-201)

2021 ◽  
Vol 9 (Suppl 3) ◽  
pp. A574-A575
Author(s):  
Giovanni Grignani ◽  
Piotr Rutkowski ◽  
Celeste Lebbe ◽  
Natalie Prinzi ◽  
Jean-jaques Grob ◽  
...  
Keyword(s):  
Cell Carcinoma ◽  
Research Ethics ◽  
Health Research ◽  
Institutional Review Board ◽  
Phase 2 ◽  
Merkel Cell ◽  
Institutional Review ◽  
Phase 2 Study ◽  
Research Ethics Board ◽  
Grade 3

BackgroundRetifanlimab (INCMGA00012) is a humanized, hinge-stabilized immunoglobulin G4 kappa (IgG4κ), anti-programmed cell death protein (PD)-1 monoclonal antibody with safety and clinical pharmacology that are characteristic for the class. Evaluation of retifanlimab in solid tumors is under investigation in phase 2 and 3 studies. POD1UM-201 is an open-label, single-arm, multicenter, phase 2 study evaluating the efficacy and safety of retifanlimab in patients with chemotherapy-naïve or chemotherapy-refractory advanced/metastatic Merkel cell carcinoma (MCC). Updated results from the chemotherapy-naïve cohort are reported here.MethodsEligible patients were ≥18 years of age, had metastatic or recurrent unresectable loco-regional MCC, Eastern Cooperative Oncology Group performance status ≤1, measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, and had not received prior systemic treatment for MCC. Retifanlimab 500 mg IV every 4 weeks (Q4W) was administered for up to 2 years. The primary endpoint was overall response rate (ORR) assessed by independent central review per RECIST v1.1. Secondary endpoints included duration of response, disease control rate (DCR; defined as proportion of patients with either an objective response or stable disease lasting at least 6 months), progression-free survival, overall survival, safety, and pharmacokinetics.ResultsAs of April 16, 2021, 87 patients with chemotherapy-naïve advanced/metastatic MCC had received retifanlimab. Per protocol, the primary efficacy analyses are based on the first 65 patients assessed. At the data cutoff, 34 of these 65 patients (52.3%) were on treatment; 4 (6.2%) had completed treatment; and 27 (41.5%) had discontinued treatment for reasons including disease progression (18 [27.7%]), adverse event (AE; 7 [10.8%]), death (1 [1.5%]), and physician decision (1 [1.5%]). The ORR in these patients was 46.2% (n=30: complete response, 8 [12.3%]; partial response, 22 [33.8%]). The DCR was 53.8% (n=35). Other secondary efficacy results are not yet mature. Among all treated patients (n=87), 66 (75.9%) had a treatment-emergent AE (TEAE), 25 (28.7%) had a grade ≥3 TEAE, and 12 (13.8%) had a grade ≥3 treatment-related AE. Twenty-three patients (26.4%) had an immune-related AE (irAE), and 8 (9.2%) had a grade ≥3 irAE. Four patients (4.6%) discontinued treatment due to irAEs (peripheral sensorimotor neuropathy, pancreatitis, eosinophilic fasciitis, and polyarthritis [each n=1]). One patient (1.1%) had a grade 3 infusion reaction.ConclusionsThese data from the POD1UM-201 trial show that retifanlimab monotherapy at 500 mg Q4W continues to demonstrate promising clinical activity and safety in patients with advanced/metastatic chemotherapy-naïve MCC. Updated results will be presented at the meeting.AcknowledgementsThe study is sponsored by Incyte Corporation (Wilmington, DE). Statistical support was provided by Xiaohan Xu of Incyte Corporation. Editorial assistance was provided by Matthew Bidgood of Envision Pharma Group (Philadelphia, PA, USA).Trial RegistrationClinicaltrials.gov NCT03599713; EudraCT 2018-001627-39Ethics ApprovalThe study was approved by institutional review boards or independent ethics committees in Canada (McGill University Health Center-Research Ethics Board [MP-37-2019-5103, MEO-37-2019-1616]; Ontario Cancer Research Ethics Board [1728]; Health Research Ethics Board of Alberta – Cancer Committee [HREBA.CC-19-0004, HREBA.CC-19-0020]); Czech Republic (Eticka komise Fakultni nemocnice Kralovske Vinohrady, Eticka komise IKEM a FTNsP, Eticka komise Nemocnice Na Bulovce, Statni ustav pro kontrolu leciv, Eticka komise FN a LF UP Olomouc [169/18MEK24, LEK/04/07/2018, (L-18-85) 8522/23.3.2021, 22.3.2021/9965/EK-Z]); France (Comité de Protection des Personnes Ile de France X [CNRIPH : 18.11.19.49212/Id. 2043]; Agence Nationale de Sécurité du Médicament et des Produits de Santé); Germany (Ethik-Kommission der Medizinischen Fakultaet der Universitaet Duisburg-Essen [18-8371-AF]; Bundesamt fuer Strahlenschutz; Paul-Ehrlich Institute); Hungary (Egeszsegugyi Tudomanyos Tanacs Klinikai Farmakologiai Etikai Bizottsaga [IV/2407-0/2021-EKL, OGYÉI/11697-2/2021]; Orszagos Gyogyszereszeti es Elelmezes-egeszsegugyi Intezet); Italy (Comitato Etico IRCCS Pascale Napoli [116/21 E - 87/18]; Comitato Etico IRCCS di Candiolo [232/2021]; Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari [736/CE]; Comitato Etico Locale per la Sperim. Clin. dei Medicinali dell’Az. Osp.ra Univ.ria Senese di Siena [14107]; Comitato Etico dell’IRCCS Istituto Nazionale per la Ricerca sul Cancro di Genova [389/2018 - 24/05/2021]; Comitato etico degli IRCCS Istituto Europeo di Oncologia e Centro Cardiologico Monzino [IEO 948 - RE3065/IB Edition 7 dated 10Nov2020 (SA7)]; Comitato Etico, Fondazione IRCCS Istituto Nazionale dei Tumori, .c. Medicina Oncologica 1 – Fondazio [INT 01/19]; Comitato Etico IRCCS Istituto Oncologico Veneto di Padova [EM 109/2021]; Comitato Etico dell’IRCCS Istituto Dermopatico dell’Immacolata Ospedale Generale S. Carlo di Roma [550/7]; AIFA – Agenzia Italiana del Farmaco [0040152-01/04/2021-AIFA-AIFA_USC-P]; Comitatao Etico Policlinico di Modena [1017/2018/FARM/AOUMO - EMENDAMENTO SOSTANZIALE IB EDIZIONE 7 DEL 10/11/20 (201800162739-010) (p. 9869/21)]); Poland (Komisja Bioetyczna przy Centrum Onkologii [no. 55/2019]; Office for Registration of Medicinal Products, Medical Devices and Biocidal Products [UR/DBL/D/328/2019]); Spain (CEIC Hospital General Universitario Gregorio Marañon [280/18]; Agencia Española del Medicamento y Productos Sanitarios); Switzerland (Kantonale Ethikkommission Zürich (KEK-Zürich) [2019-00200]; Swissmedic [2019DR2035]); United Kingdom (North East – York Research Ethics Committee [248465]; Medicines and Healthcare products Regulatory Agency; Health Research Authority); United States (Copernicus Group IRB; Western Institutional Review Board [20181738, Work order number -– IQV1-18-309]; Roswell Park Cancer Institute IRB [STUDY00000802/P 75918]; Inova Institutional Review Board, Human Research Protection Program; Stanford IRB Research Compliance Office [48198]; Rush University Medical Center [18072304-IRB01]; University of Miami IRB; Mayo Clinic IRB – Rochester).

scholarly journals Evaluating the efficacy of intranasal oxytocin on pain and function among individuals who experience chronic pain: a protocol for a multisite, placebo-controlled, blinded, sequential, within-subjects crossover trial

BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e055039
Author(s):  
Joshua A. Rash ◽  
Tavis S. Campbell ◽  
Lynn Cooper ◽  
David Flusk ◽  
Aaron MacInnes ◽  
...  
Keyword(s):  
Chronic Pain ◽  
British Columbia ◽  
Side Effects ◽  
Research Ethics ◽  
Health Research ◽  
Newfoundland And Labrador ◽  
Crossover Trial ◽  
Adverse Side Effects ◽  
Research Ethics Board ◽  
And Function

IntroductionCurrent treatments for chronic pain (eg, opioids) can have adverse side effects and rarely result in resolution of pain. As such, there is a need for adjuvant analgesics that are non-addictive, have few adverse side effects and are effective for pain management across several chronic pain conditions. Oxytocin is a naturally occurring hormone that has gained attention for its potential analgesic properties. The objective of this trial is to evaluate the efficacy of intranasal oxytocin on pain and function among adults with chronic pain.Methods and analysisThis is a placebo-controlled, triple-blind, sequential, within-subject crossover trial. Adults with chronic neuropathic, pelvic and musculoskeletal pain will be recruited from three Canadian provinces (British Columbia, Alberta and Newfoundland and Labrador, respectively). Enrolled patients will provide one saliva sample pretreatment to evaluate basal oxytocin levels and polymorphisms of the oxytocin receptor gene before being randomised to one of two trial arms. Patients will self-administer three different oxytocin nasal sprays twice daily for a period of 2 weeks (ie, 24 IU, 48 IU and placebo). Patients will complete daily diaries, including standardised measures on day 1, day 7 and day 14. Primary outcomes include pain and pain-related interference. Secondary outcomes include emotional function, sleep disturbance and global impression of change. Intention-to-treat analyses will be performed to evaluate whether improvement in pain and physical function will be observed posttreatment.Ethics and disseminationTrial protocols were approved by the Newfoundland and Labrador Health Research Ethics Board (HREB #20227), University of British Columbia Clinical Research Ethics Board (CREB #H20-00729), University of Calgary Conjoint Health Research Ethics Board (REB20 #0359) and Health Canada (Control # 252780). Results will be disseminated through publication in peer-reviewed journals and presentations at scientific conferences.Trial registration numberNCT04903002; Pre-results.

scholarly journals Prenatal Exposure And Child brain and mental Health (PEACH) study: protocol for a cohort study of children and youth with prenatal alcohol exposure

BMJ Open ◽  
2021 ◽  
Vol 11 (5) ◽  
pp. e051660
Author(s):  
Catherine A Lebel ◽  
W. Ben Gibbard ◽  
Christina Tortorelli ◽  
Jacqueline Pei ◽  
Christian Beaulieu ◽  
...  
Keyword(s):  
Mental Health ◽  
Prenatal Exposure ◽  
Health Research ◽  
Prenatal Alcohol Exposure ◽  
Alcohol Exposure ◽  
Anxiety And Depression ◽  
Depression Symptoms ◽  
Research Ethics Board ◽  
Prenatal Alcohol ◽  
The University

IntroductionFetal alcohol spectrum disorder (FASD), which is caused by prenatal alcohol exposure (PAE), affects an estimated 4% of North Americans, and is the most common preventable cause of intellectual disability. Mental health problems, including anxiety and depression, are experienced by nearly all individuals with FASD. However, there is very limited knowledge about effective mental health treatments for individuals with FASD; effective treatments are hindered in part due to a lack of understanding of the basic neurobiology underlying internalising disorders in youth with FASD.Methods and analysisThe Prenatal Exposure And Child brain and mental Health (PEACH) study includes children aged 7–18 years. We will use longitudinal neuroimaging (anatomical T1-weighted, diffusion and passive viewing function MRI) and mental health assessments (Behaviour Assessment Scale for Children, Multi-dimensional Anxiety Scale for Children, Children’s Depression Inventory (CDI-2), Kiddie Scale of Affective Disorders) to: (1) characterise brain development trajectories in youth with FASD, (2) determine whether brain alterations mediate increased anxiety and depression in youth with FASD and (3) identify baseline brain features that predict changes of anxiety and depression symptoms over the next 2 years. All of this will be done while considering sex and adverse postnatal experiences, which can significantly impact mental health and brain outcomes. This project will forge new understanding of FASD and mental health from a neurobiological perspective, highlighting key time periods (ie, sensitive windows) and brain regions (ie, that may be susceptible to neurostimulation), while identifying factors that predict individual trajectories of anxiety and depression symptoms.Ethics and disseminationThis study was approved by the University of Calgary Conjoint Health Research Ethics Board and the University of Alberta Health Research Ethics Board. Study results will be disseminated in peer-reviewed journals, at relevant conferences and in conjunction with our knowledge mobilisation partners.

International Health Research Ethics

2020 ◽  
Author(s):  
Bridget Pratt
Keyword(s):  
Research Ethics ◽  
Health Research ◽  
International Research ◽  
International Health ◽  
Middle Income Country ◽  
Income Country ◽  
Benefit Sharing ◽  
Middle Income ◽  
Ethical Concerns ◽  
Low And Middle Income

Health research funded by organizations from HICs and conducted in low- and middle-income countries has grown significantly since 1990. Power imbalances and inequities frequently (but not always) exist at each stage of the international research process. Unsurprisingly then, a variety of ethical concerns commonly arise in the context of international health research, such as inequities in funding, the semi-colonial nature of international research models, the brain drain of low- and middle-income country researchers, and inequities in partnerships between HIC and low- and middle-income country researchers. In this chapter, these (and other) ethical concerns are introduced and the following ethical concepts to address the concerns are then discussed: responsiveness, standard of care, benefit sharing, community engagement, and social value. Existing guidance and remaining debates about how to specify each of the concepts are summarized. The chapter concludes by highlighting the existence of epistemic injustices within the field of international research ethics.

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