Voyage vers l’inconnu : le point de vue des diplômés internationaux en médecine sur le chemin de la résidence au Canada pendant la pandémie de la COVID-19

The COVID-19 pandemic has had a tremendous effect on education programs worldwide, including medical education. Particularly, International Medical Graduates (IMGs) planning to pursue residency training in Canada have been profoundly impacted. Cancellation of away electives, as well as changes to the format, timeline, and requirements of mandatory medical licensing exams has left IMG residency applicants in uncharted territory. Given that IMGs comprise up to 25% of the Canadian healthcare force, and often are based in underserviced areas, the licensure and eligibility of IMGs to continue to enter the Canadian healthcare force is of the utmost importance in the midst of the COVID-19 pandemic. As the pandemic evolves, it is imperative that key decision makers and stakeholders continue to consider the downstream effect for IMGs and their eligibility to practice in Canada.La pandémie de la COVID-19 a fortement affecté les programmes d'éducation dans le monde entier, y compris l’éducation médicale. En particulier, les diplômés internationaux en médecine (DIM) qui prévoyaient s’inscrire à un programme de résidence au Canada ont été profondément touchés. L'annulation des stages à l’étranger, ainsi que les changements apportés au format, au calendrier et aux exigences des examens requis pour l'obtention du permis d'exercice de la médecine ont laissé en territoire inconnu les candidats internationaux aux programmes de résidence. Étant donné que les DIM représentent jusqu'à 25 % des professionnels de la santé au Canada et qu'ils exercent souvent dans les régions mal desservies, l’octroi de permis d’exercice et le recrutement de DIM dans le réseau de la santé canadien revêtent une importance capitale en contexte de pandémie de la COVID-19. À mesure que la pandémie évolue, il est impératif que les principaux décideurs et intervenants continuent de tenir compte des effets néfastes qu’elle peut avoir pour les DIM et leur admissibilité à l’exercice de la profession au Canada

Range and variability of outcomes reported in randomized trials conducted in patients with polycystic kidney disease: A systematic review

Rationale & Objective: Trials in autosomal dominant polycystic kidney disease (ADPKD) have increased, but their impact on decision making has been limited. Because heterogeneity in reported outcomes may be responsible, we assessed their range and variability in ADPKD trials. Study Design: Systematic review. Setting & Study Population: Adult participants in clinical trials in ADPKD. Selection Criteria for Studies: We included trials that studied adults and were published in English. For trials that enrolled patients without ADPKD, only those enrolling ≥50% of participants with ADPKD were included. Data Extraction: We extracted information on all discrete outcome measures, grouped them into 97 domains, and classified them into clinical, surrogate, and patient-reported categories. For each category, we choose the 3 most frequently reported domains and performed a detailed analysis of outcome measures. Analytical Approach: Frequencies and characteristics of outcome measures were described. Results: Among 68 trials, 1,413 different outcome measures were reported. 97 domains were identified; 41 (42%) were surrogate, 30 (31%) were clinical, and 26 (27%) were patient reported. The 3 most frequently reported domains were in the surrogate category: kidney function (54; 79% of trials; using 46 measures), kidney and cyst volumes (43; 63% of trials; 52 measures), and blood pressure (27; 40% of trials, 30 measures); in the clinical category: infection (10; 15%; 21 measures), cardiovascular events (9; 13%; 6 measures), and kidney failure requiring kidney replacement therapy (8; 12%; 5 measures); and in the patient-reported category: pain related to ADPKD (16; 24%; 26 measures), pain for other reasons (11; 16%; 11 measures), and diarrhea/constipation/gas (10; 15%; 9 measures). Limitations: Outcome measures were assessed for only the top 3 domains in each category. Conclusions: The outcomes in ADPKD trials are broad in scope and highly variable. Surrogate outcomes were most frequently reported. Patient-reported outcomes were uncommon. A consensus-based set of core outcomes meaningful to patients and clinicians is needed for future ADPKD trials

Standardised Outcomes in Nephrology-Polycystic Kidney Disease (SONG-PKD): study protocol for establishing a core outcome set in polycystic kidney disease

BACKGROUND: Autosomal dominant polycystic kidney disease (ADPKD) is the most common potentially life threatening inherited kidney disease and is responsible for 5-10% of cases of end-stage kidney disease (ESKD). Cystic kidneys may enlarge up to 20 times the weight of a normal kidney due to the growth of renal cysts, and patients with ADPKD have an increased risk of morbidity, premature mortality, and other life-time complications including renal and hepatic cyst and urinary tract infection, intracranial aneurysm, diverticulosis, and kidney pain which impair quality of life. Despite some therapeutic advances and the growing number of clinical trials in ADPKD, the outcomes that are relevant to patients and clinicians, such as symptoms and quality of life, are infrequently and inconsistently reported. This potentially limits the contribution of trials to inform evidence-based decision-making. The Standardised Outcomes in Nephrology-Polycystic Kidney Disease (SONG-PKD) project aims to establish a consensus-based set of core outcomes for trials in PKD (with an initial focus on ADPKD but inclusive of all stages) that patients and health professionals identify as critically important. METHODS: The five phases of SONG-PKD are: a systematic review to identify outcomes that have been reported in existing PKD trials; focus groups with nominal group technique with patients and caregivers to identify, rank, and describe reasons for their choices; qualitative stakeholder interviews with health professionals to elicit individual values and perspectives on outcomes for trials involving patients with PKD; an international three-round Delphi survey with all stakeholder groups (including patients, caregivers, healthcare providers, policy makers, researchers, and industry) to gain consensus on critically important core outcome domains; and a consensus workshop to review and establish a set of core outcome domains and measures for trials in PKD. DISCUSSION: The SONG-PKD core outcome set is aimed at improving the consistency and completeness of outcome reporting across ADPKD trials, leading to improvements in the reliability and relevance of trial-based evidence to inform decisions about treatment and ultimately improve the care and outcomes for people with ADPKD

Core outcome domains for trials in autosomal dominant polycystic kidney disease: An international Delphi survey

Rationale & Objective Outcomes reported in trials involving patients with autosomal dominant polycystic kidney disease (ADPKD) are heterogeneous and rarely include patient-reported outcomes. We aimed to identify critically important consensus-based core outcome domains to be reported in trials in ADPKD. Study Design An international 2-round online Delphi survey was conducted in English, French, and Korean languages. Setting & Participants Patients/caregivers and health professionals completed a 9-point Likert scale (7-9 indicating critical importance) and a Best-Worst Scale. Analytical Approach The absolute and relative importance of outcomes were assessed. Comments were analyzed thematically. Results 1,014 participants (603 [60%] patients/caregivers, 411 [40%] health professionals) from 56 countries completed round 1, and 713 (70%) completed round 2. The prioritized outcomes were kidney function (importance score, 8.6), end-stage kidney disease (8.6), death (7.9), blood pressure (7.9), kidney cyst size/growth (7.8), and cerebral aneurysm (7.7). Kidney cyst–related pain was the highest rated patient-reported outcome by both stakeholder groups. Seven themes explained the prioritization of outcomes: protecting life and health, directly encountering life-threatening and debilitating consequences, specificity to ADPKD, optimizing and extending quality of life, hidden suffering, destroying self-confidence, and lost opportunities. Limitations Study design precluded involvement from those without access to internet or limited computer literacy. Conclusions Kidney function, end-stage kidney disease, and death were the most important outcomes to patients, caregivers, and health professionals. Kidney cyst–related pain was the highest rated patient-reported outcome. Consistent reporting of these top prioritized outcomes may strengthen the value of trials in ADPKD for decision making

Journey into the unknown: considering the international medical graduate perspective on the road to Canadian residency during the COVID-19 pandemic

The COVID-19 pandemic has had a tremendous effect on education programs worldwide, including medical education. Particularly, International Medical Graduates (IMGs) planning to pursue residency training in Canada have been profoundly impacted. Cancellation of away electives, as well as changes to the format, timeline, and requirements of mandatory medical licensing exams has left IMG residency applicants in uncharted territory. Given that IMGs comprise up to 25% of the Canadian healthcare force, and often are based in underserviced areas, the licensure and eligibility of IMGs to continue to enter the Canadian healthcare force is of the utmost importance in the midst of the COVID-19 pandemic. As the pandemic evolves, it is imperative that key decision makers and stakeholders continue to consider the downstream effect for IMGs and their eligibility to practice in Canada.La pandémie de la COVID-19 a fortement affecté les programmes d'éducation dans le monde entier, y compris l’éducation médicale. En particulier, les diplômés internationaux en médecine (DIM) qui prévoyaient s’inscrire à un programme de résidence au Canada ont été profondément touchés. L'annulation des stages à l’étranger, ainsi que les changements apportés au format, au calendrier et aux exigences des examens requis pour l'obtention du permis d'exercice de la médecine ont laissé en territoire inconnu les candidats internationaux aux programmes de résidence. Étant donné que les DIM représentent jusqu'à 25 % des professionnels de la santé au Canada et qu'ils exercent souvent dans les régions mal desservies, l’octroi de permis d’exercice et le recrutement de DIM dans le réseau de la santé canadien revêtent une importance capitale en contexte de pandémie de la COVID-19. À mesure que la pandémie évolue, il est impératif que les principaux décideurs et intervenants continuent de tenir compte des effets néfastes qu’elle peut avoir pour les DIM et leur admissibilité à l’exercice de la profession au Canada

Establishing a core outcome set for autosomal dominant polycystic kidney disease: Report of the Standardized Outcomes in Nephrology–Polycystic Kidney Disease (SONG-PKD) consensus workshop

The omission of outcomes that are of relevance to patients, clinicians, and regulators across trials in autosomal dominant polycystic kidney disease (ADPKD) limits shared decision making. The Standardized Outcomes in Nephrology–Polycystic Kidney Disease (SONG-PKD) Initiative convened an international consensus workshop on October 25, 2018, to discuss the identification and implementation of a potential core outcome set for all ADPKD trials. This article summarizes the discussion from the workshops and the SONG-PKD core outcome set. Key stakeholders including 11 patients/caregivers and 47 health professionals (nephrologists, policy makers, industry, and researchers) attended the workshop. Four themes emerged: “Relevance of trajectory and impact of kidney function” included concerns about a patient's prognosis and uncertainty of when they may need to commence kidney replacement therapy and the lack of an early prognostic marker to inform long-term decisions; “Discerning and defining pain specific to ADPKD” highlighted the challenges in determining the origin of pain, adapting to the chronicity and repeated episodes of pain, the need to place emphasis on pain management, and to have a validated measure for pain; “Highlighting ADPKD consequences” encompassed cyst-related complications and reflected patient's knowledge because of family history and the hereditary nature of ADPKD; and “Risk for life-threatening but rare consequences” such as cerebral aneurysm meant considering both frequency and severity of the outcome. Kidney function, mortality, cardiovascular disease, and pain were established as the core outcomes for ADPKD

Implementing core outcomes in kidney disease: report of the Standardized Outcomes in Nephrology (SONG) implementation workshop

There are an estimated 14,000 randomized trials published in chronic kidney disease. The most frequently reported outcomes are biochemical endpoints, rather than clinical and patient-reported outcomes including cardiovascular disease, mortality, and quality of life. While many trials have focused on optimizing kidney health, the heterogeneity and uncertain relevance of outcomes reported across trials may limit their policy and practice impact. The international Standardized Outcomes in Nephrology (SONG) Initiative was formed to identify core outcomes that are critically important to patients and health professionals, to be reported consistently across trials. We convened a SONG Implementation Workshop to discuss the implementation of core outcomes. Eighty-two patients/caregivers and health professionals participated in plenary and breakout discussions. In this report, we summarize the findings of the workshop in two main themes: socializing the concept of core outcomes, and demonstrating feasibility and usability. We outline implementation strategies and pathways to be established through partnership with stakeholders, which may bolster acceptance and reporting of core outcomes in trials, and encourage their use by end-users such as guideline producers and policymakers to help improve patient-important outcomes