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Background: Heart failure (HF) affects many patients who are older and frail, presenting multiple physical barriers to accessing specialty care in a traditional ambulatory clinic model. Here, we present an assisted virtual care model in which a home visiting nurse facilitated video visits with a HF cardiologist to follow homebound, frail, and older patients with HF. Methods: This is a pragmatic, quasi-experimental, pre–post, single-centre study. It included homebound, frail, and older patients with HF from 2015 to 2019 who were followed for 1 year; in-person clinic visits were completely replaced by nurse-facilitated virtual video visits. Outcomes evaluated included annualized hospitalization rate, number of hospitalization days, and number of emergency department visits. Results: A total of 49 patients were included, with a median age of 86 (83-93) years, and were followed for 1 year after enrollment. Among patients enrolled, HF with preserved ejection fraction was the most common subtype (57%). Compared to the year prior to enrollment, patients had a lower mortality-adjusted all-cause annualized hospitalization rate in the year following enrollment (2.57 vs 1.78, P < 0.0001). Compared to the year prior, the number of mortality-adjusted all-cause hospitalization days was significantly lower in the year following enrollment (27.2 vs 21.4, P < 0.0001). There was a reduction in the number of all-cause annualized emergency department visits (3.10 vs 2.27, P = 0.003). Conclusions: Nurse-assisted virtual visits may be a preferable strategy for homebound, frail, and older patients with HF to receive longitudinal care. This approach may represent a plausible strategy to care for other patients with significant barriers to accessing specialized cardiac care. Résumé: Contexte: L’insuffisance cardiaque (IC) touche de nombreux patients âgés et fragiles, et dresse maints obstacles physiques à l’accès aux soins spécialisés au sein d’un modèle classique de soins cliniques ambulatoires. Dans le présent article, nous exposons un modèle de soins virtuels assistés où une infirmière visiteuse assure par vidéoconsultation, avec un cardiologue, le suivi de patients âgés et fragiles atteints d’IC confinés à la maison. Méthodologie: Une étude monocentrique et pragmatique, quasi expérimentale de type « avant-après », a été menée de 2015 à 2019 auprès de patients âgés et fragiles atteints d’IC confinés à la maison. Les patients ont été suivis durant un an; les consultations en personne ont été entièrement remplacées par des vidéoconsultations effectuées par une infirmière. Les paramètres évalués comprenaient le taux annualisé d’hospitalisation, le nombre de jours d’hospitalisation et le nombre de consultations aux urgences. Résultats: Au total, 49 patients dont l’âge médian était de 86 ans (83-93 ans) ont été suivis durant un an à compter de leur admission à l’étude. L’IC à fraction d’éjection préservée était le sous-type d’IC le plus fréquent (57 %) chez les patients participant à l’étude. Par comparaison à l’année précédente, le taux annualisé d’hospitalisation toutes causes confondues ajusté en fonction de la mortalité a été plus faible chez les patients au cours de l’année où ils ont été suivis dans le cadre de l’étude (2,57 vs 1,78, P < 0,0001). Toujours par comparaison à l’année précédente, le nombre de jours d’hospitalisation toutes causes confondues ajusté en fonction de la mortalité a été significativement inférieur chez les patients au cours de l’année où ils ont été suivis dans le cadre de l’étude (27,2 vs 21,4, P < 0,0001). Le nombre annualisé de consultations aux urgences toutes causes confondues a quant à lui diminué (3,10 vs 2,27, P = 0,003). Conclusions: Les consultations virtuelles assistées par une infirmière peuvent constituer une stratégie à privilégier dans la prestation de soins longitudinaux à des patients âgés et fragiles atteints d’IC qui sont confinés à la maison. Cette approche pourrait représenter une stratégie plausible pour prodiguer des soins à d’autres patients qui sont confrontés à d’importants obstacles limitant leur accès à des soins spécialisés en cardiologie.

Background Antibiotic overprescribing in long-term care settings is driven by prescriber preferences and is associated with preventable harms for residents. We aimed to determine whether peer comparison audit and feedback reporting for physicians reduces antibiotic overprescribing among residents. Methods We employed a province wide, difference-in-differences study of antibiotic prescribing audit and feedback, with an embedded pragmatic randomized controlled trial (RCT) across all long-term care facilities in Ontario, Canada, in 2019. The study year included 1238 physicians caring for 96 185 residents. In total, 895 (72%) physicians received no feedback; 343 (28%) were enrolled to receive audit and feedback and randomized 1:1 to static or dynamic reports. The primary outcomes were proportion of residents initiated on an antibiotic and proportion of antibiotics prolonged beyond 7 days per quarter. Results Among all residents, between the first quarter of 2018 and last quarter of 2019, there were temporal declines in antibiotic initiation (28.4% to 21.3%) and prolonged duration (34.4% to 29.0%). Difference-in-differences analysis confirmed that feedback was associated with a greater decline in prolonged antibiotics (adjusted difference −2.65%, 95% confidence interval [CI]: −4.93 to −.28%, P = .026), but there was no significant difference in antibiotic initiation. The reduction in antibiotic durations was associated with 335 912 fewer days of treatment. The embedded RCT detected no differences in outcomes between the dynamic and static reports. Conclusions Peer comparison audit and feedback is a pragmatic intervention that can generate small relative reductions in the use of antibiotics for prolonged durations that translate to large reductions in antibiotic days of treatment across populations. Clinical Trials Registration. NCT03807466.

Background Patients admitted to the hospital with COPD are commonly managed with inhaled short-acting bronchodilators, sometimes in lieu of the long-acting bronchodilators they take as outpatients. If held on admission, these long-acting inhalers should be re-initiated upon discharge; however, health-care transitions sometimes result in unintentional discontinuation. Research Question What is the risk of unintentional discontinuation of long-acting muscarinic antagonist (LAMA) and long-acting beta-agonist and inhaled corticosteroid (LABA-ICS) combination medications following hospital discharge in older adults with COPD? Study Design and Methods A retrospective cohort study was conducted by using health administrative data from 2004 to 2016 from Ontario, Canada. Adults with COPD aged ≥ 66 years who had filled prescriptions for a LAMA or LABA-ICS continuously for ≥ 1 year were included. Log-binomial regression models were used to determine risk of medication discontinuation following hospitalization in each medication cohort. Results Of the 27,613 hospitalization discharges included in this study, medications were discontinued 1,466 times. Among 78,953 patients with COPD continuously taking a LAMA or LABA-ICS, those hospitalized had a higher risk of having medications being discontinued than those who remained in the community (adjusted risk ratios of 1.50 [95% CI, 1.34-1.67; P Interpretation In an observational study of highly compliant patients with COPD, hospitalization was associated with an increased risk of long-acting inhaler discontinuation. These Results suggest a likely larger discontinuation problem among less adherent patients and should be confirmed and quantified in a prospective cohort of patients with COPD and average compliance. Quality improvement efforts should focus on safe transitions and patient medication reconciliation following discharge.

Background It is important to understand clinical features of bacteremic urinary tract infection (bUTI), because bUTI is a serious infection that requires prompt diagnosis and antibiotic therapy. Escherichia coli is the most common and important uropathogen. The objective of our study was to characterize the clinical presentation of E coli bUTI. Methods Retrospective cohort study of consecutive adult patients admitted for community acquired E. coli bacteremia from January 1, 2015 to December 31, 2016 was conducted at 4 acute care academic and community hospitals in Toronto, Ontario, Canada. Logistic regression models were developed to identify E coli bUTI cases without urinary symptoms. Results Of 462 patients with E. coli bacteremia, 284 (61.5%) patients had a urinary source. Of these 284 patients, 161 (56.7%) had urinary symptoms. In a multivariable model, bUTI without urinary symptoms were associated with older age (age p = 0.0523; age 75–84 years had OR of 1.80 95% CI 0.91–3.57 p = 0.0914; age > =85 years had OR of 2.95 95% CI 1.44–6.18 p = 0.0036) and delirium (OR of 2.12 95% CI 1.13–4.03 p = 0.0207). Sepsis by SIRS criteria was present in 274 (96.5%) of all bUTI cases and 119 (96.8%) of bUTI cases without urinary symptoms. Conclusion The majority of patients with E. coli bacteremia had a urinary source. A significant proportion of bUTI cases had no urinary symptoms elicited on history. Elderly and delirious patients were more likely to have bUTI without urinary symptoms. In elderly and delirious patients with sepsis by SIRS criteria but without a clear infectious source, clinicians should suspect, investigate, and treat for bUTI.

An important potential unintended consequence of the growth of surgical subspecialization is the narrowing of surgical practice among comprehensive ophthalmologists. We investigated trends in the narrowing of surgical practice and the exclusive provision of cataract surgery.Population-based, retrospective study.All ophthalmologists and all ophthalmologic surgical patients in Ontario from 1994 to 2016.We linked several health care databases to evaluate the proportion of ophthalmologists who exclusively provided cataract surgery (and no other ophthalmologic surgery) and the proportion who provided other types of ophthalmologic surgical care. To further investigate surgical focus, we evaluated the proportion of surgical cases within each surgical area for each ophthalmologist.Between 1994 and 2016, the proportion of ophthalmologists who exclusively provided cataract surgery rose from 10.0% to 34.9% (p0.0001). In contrast, the proportions of ophthalmologists providing other types of subspecialized surgical care were stable over the study period. Cataract surgeons showed high degrees of focus with a median percentage of surgical cases approaching 100% in all years. Among exclusive cataract surgeons, the median annual cataract case volume increased from 138 (interquartile range: 87-214) to 529 (interquartile range: 346-643) between 1994 and 2009 (p0.0001) and then plateaued.Between 1994 and 2016, exclusive cataract surgical focus among ophthalmologists in Ontario rose dramatically from 1 in 10 to 1 in 3 surgeons. This evolution was similar among recent graduates and established ophthalmologists. Our data may have important implications for policies regarding surgeon human resources as well as residency and fellowship training programs.

Background: In-hospital transfers such as from the intensive care unit (ICU) to the general internal medicine (GIM) ward place patients at risk of adverse events. A structured handover tool may improve transitions from the ICU to the GIM ward. Objective: To develop, implement, and evaluate a customized user-designed transfer tool to improve transitions from the ICU to the GIM ward. Methods: This was a pre–post intervention study at a tertiary academic hospital. We developed and implemented a user-designed, structured, handwritten ICU-to-GIM transfer tool. The tool included active medical issues, functional status, medications and medication changes, consulting services, code status, and emergency contact information. Transfer tool users included GIM physicians, ICU physicians, and critical care rapid response team nurses. An implementation audit and mixed qualitative and quantitative analysis of pre–post survey responses was used to evaluate clinician satisfaction and the perceived quality of patient transfers. Results: The pre–post survey response rate was 51.8% (99/191). Respondents included GIM residents (58.5%), ICU rapid response team physicians and nurses (24.2%), and GIM attending physicians (17.2%). Less than half of clinicians (48.8%) reported that the preintervention transfer process was adequate. Clinicians who used the transfer tool reported that the transfer process was improved (93.3% vs. 48.8%, P = 0.03). Clinician-reported understanding of medication changes in the ICU increased (69.2% vs. 29.1%, P = 0.004), as did their ability to plan for a safe hospital discharge (69.2% vs. 31.0%, P = 0.01). However, only 64.2% of audited transfers used the tool. Frequently omitted sections included home medications (missing in 83.4% of audits), new medications (33.3%), and secondary diagnosis (33.3%). Thematic analysis of free-text responses identified areas for improvement including clarifying the course of ICU events and enhancing tool usability. Conclusion: A user-designed, structured, handwritten transfer tool may improve the perceived quality of patient transfers from the ICU to the GIM wards.

Background:Antibiotic use in nursing homes is often inappropriate, in terms of overuse and misuse, and it can be linked to adverse events and antimicrobial resistance. Antimicrobial stewardship programs (ASPs) can optimize antibiotic use by minimizing unnecessary prescriptions, treatment cost, and the overall spread of antimicrobial resistance. Nursing home providers and residents are candidates for ASP implementation, yet guidelines for implementation are limited.Objective:To support nursing home providers with the selection and adoption of ASP interventions.Design and Setting:A multiphase modified Delphi method to assess 15 ASP interventions across criteria addressing scientific merit, feasibility, impact, accountability, and importance. This study included surveys supplemented with a 1-day consensus meeting.Participants:A 16-member multidisciplinary panel of experts and resident representatives.Results:From highest to lowest, 6 interventions were prioritized by the panel: (1) guidelines for empiric prescribing, (2) audit and feedback, (3) communication tools, (4) short-course antibiotic therapy, (5) scheduled antibiotic reassessment, and (6) clinical decision support systems. Several interventions were not endorsed: antibiograms, educational interventions, formulary review, and automatic substitution. A lack of nursing home resources was noted, which could impede multifaceted interventions.Conclusions:Nursing home providers should consider 6 key interventions for ASPs. Such interventions may be feasible for nursing home settings and impactful for improving antibiotic use; however, scientific merit supporting each is variable. A multifaceted approach may be necessary for long-term improvement but difficult to implement.

Background More than 50% of Canadian adult patients wait longer than four weeks to see a specialist after referral from primary care. Access to accurate wait time information may help primary care physicians choose the timeliest specialist to address a patient’s specific needs. We conducted a mixed-methods study to assess if primary to specialist care wait times can be extracted from electronic medical records (EMR), analyzed the wait time information, and used focus groups and interviews to assess the potential clinical utility of the wait time information. Methods Two family practices were recruited to examine primary care physician to specialist wait times between January 2016 and December 2017, using EMR data. The primary outcome was the median wait time from physician referral to specialist appointment for each specialty service. Secondary outcomes included the physician and patient characteristics associated with wait times as well as qualitative analyses of physician interviews about the resulting wait time reports. Results Wait time data can be extracted from the primary care EMR and converted to a report format for family physicians and specialists to review. After data cleaning, there were 7141 referrals included from 4967 unique patients. The 5 most common specialties referred to were Dermatology, Gastroenterology, Ear Nose and Throat, Obstetrics and Gynecology and Urology. Half of the patients were seen by a specialist within 42 days, 75% seen within 80 days and all patients within 760 days. There were significant differences in wait times by specialty, for younger patients, and those with urgently labelled medical situations. Overall, wait time reports were perceived by clinicians to be important since they could help family physicians decide how to triage referrals and might lead to system improvements. Conclusions Wait time information from primary to specialist care can aid in decision-making around specialist referrals, identify bottlenecks, and help with system planning. This mixed method study is a starting point to review the importance of providing wait time data for both family physicians, specialists and local health systems. Future work can be directed towards developing wait time reporting functionality and evaluating if wait time information will help increase system efficiency and/or improve provider and patient satisfaction.

Background and objectives Survivors of AKI are at higher risk of CKD and death, but few patients see a nephrologist after hospital discharge. Our objectives during this 2-year vanguard phase trial were to determine the feasibility of randomizing survivors of AKI to early follow-up with a nephrologist or usual care, and to collect data on care processes and outcomes. Design, setting, participants, & measurements We performed a randomized controlled trial in patients hospitalized with Kidney Disease Improving Global Outcomes (KDIGO) stage 2–3 AKI at four hospitals in Toronto, Canada. We randomized patients to early nephrologist follow-up (standardized basket of care that emphasized BP control, cardiovascular risk reduction, and medication safety) or usual care from July 2015 to June 2017. Feasibility outcomes included the proportion of eligible patients enrolled, seen by a nephrologist, and followed to 1 year. The primary clinical outcome was a major adverse kidney event at 1 year, defined as death, maintenance dialysis, or incident/progressive CKD. Results We screened 3687 participants from July 2015 to June 2017, of whom 269 were eligible. We randomized 71 (26%) patients (34 to nephrology follow-up and 37 to usual care). The primary reason stated for declining enrollment included hospitalization-related fatigue (n=65), reluctance to add more doctors to the health care team (n=59), and long travel times (n=40). Nephrologist visits occurred in 24 of 34 (71%) intervention participants, compared with three of 37 (8%) participants randomized to usual care. The primary clinical outcome occurred in 15 of 34 (44%) patients in the nephrologist follow-up arm, and 16 of 37 (43%) patients in the usual care arm (relative risk, 1.02; 95% confidence interval, 0.60 to 1.73). Conclusions Major adverse kidney events are common in AKI survivors, but we found the in-person model of follow-up posed a variety of barriers that was not acceptable to many patients. Clinical Trial registry name and registration number: Nephrologist Follow-up versus Usual Care after an Acute Kidney Injury Hospitalization (FUSION), NCT02483039 CJASN 16: 1005–1014, 2021. doi: https://doi.org/10.2215/CJN.17331120

OBJECTIVES Cost-effectiveness analyses are increasingly used to aid decisions about resource allocation in healthcare; this practice is slow to translate into critical care. We sought to identify and summarize original cost-effectiveness studies presenting cost per quality-adjusted life year, incremental cost-effectiveness ratios, or cost per life-year ratios for treatments used in ICUs. DESIGN We conducted a systematic search of the English-language literature for cost-effectiveness analyses published from 1993 to 2018 in critical care. Study quality was assessed using the Drummond checklist. SETTING Critical care units. PATIENTS OR SUBJECTS Critical care patients. INTERVENTIONS Identified studies with cost-effectiveness analyses. MEASUREMENTS AND MAIN RESULTS We identified 97 studies published through 2018 with 156 cost-effectiveness ratios. Reported incremental cost-effectiveness ratios ranged from -$119,635 (hypothetical cohort of patients requiring either intermittent or continuous renal replacement therapy) to $876,539 (data from an acute renal failure study in which continuous renal replacement therapy was the most expensive therapy). Many studies reported favorable cost-effectiveness profiles (i.e., below $50,000 per life year or quality-adjusted life year). However, several therapies have since been proven harmful. Over 2 decades, relatively few cost-effectiveness studies in critical care have been published (average 4.6 studies per year). There has been a more recent trend toward using hypothetical cohorts and modeling scenarios without proven clinical data (2014-2018: 19/33 [58%]). CONCLUSIONS Despite critical care being a significant healthcare cost burden there remains a paucity of studies in the literature evaluating its cost effectiveness.

We implemented twice-weekly academic detailing rounds in 2015 as an antimicrobial stewardship (AMS) intervention in solid organ transplant (SOT) patients, led by an AMS pharmacist and a transplant infectious diseases physician. They reviewed SOT patients’ antimicrobials and made recommendations to prescribers on antimicrobial regimens, diagnostics investigations, and appropriate referrals for transplant infectious diseases consultation. To determine the impact of the intervention, we adjudicated antimicrobials prescriptions using established AMS principles, and compared the proportion of AMS-concordance regimens pre-intervention (2013) with post-intervention (2016) via 4-point-prevalence surveys conducted in each period. All admitted SOT patients who were receiving antimicrobial treatment on survey days were included. Primary outcome was the percentage of antimicrobial regimen adjudicated as AMS concordant. Secondary outcomes were percentage of AMS concordance in patients consulted by transplant infectious diseases; categories of AMS discordance; antimicrobial consumption in defined daily dose/100 patient-days (DDD/100PD); antimicrobial cost in CAD$/PD; and C. difficile infections. Balancing measures were length of stay, 30-day readmission, and in-hospital mortality. We compared outcomes using χ2 test or t-test; significant difference was defined as p

Background and objectivesRecent years have seen increasing calls for more proactive use of patient complaints to develop effective system-wide changes, analogous to the intended functions of incident reporting and root cause analysis (RCA) to improve patient safety. Given recent questions regarding the impact of RCAs on patient safety, we sought to explore the degree to which current patient complaints processes generate solutions to recurring quality problems.Design/settingQualitative analysis of semistructured interviews with 21 patient relations personnel (PRP), nursing and physician leaders at three teaching hospitals (Toronto, Canada).ResultsChallenges to using the patient complaints process to drive hospital-wide improvement included: (1) Complaints often reflect recalcitrant system-wide issues (eg, wait times) or well-known problems which require intensive efforts to address (eg, poor communication). (2) The use of weak change strategies (eg, one-off educational sessions). (3) The handling of complaints by unit managers so they never reach the patient relations office. PRP identified giving patients a voice as their primary goal. Yet their daily work, which they described as ‘putting out fires’, focused primarily on placating patients in order to resolve complaints as quickly as possible, which may in effect suppress the patient voice.ConclusionsUsing patient complaints to drive improvement faces many of the challenges affecting incident reporting and RCA. The emphasis on ‘putting out fires’ may further detract from efforts to improve care for future patients. Systemically incorporating patients’ voices in clinical operations, as with co-design and other forms of authentic patient engagement, may hold greater promise for meaningful improvements in the patient experience than do RCA-like analyses of patient complaints.

Purpose Tamsulosin is associated with intraoperative floppy iris syndrome (IFIS), an important risk factor for complications during cataract surgery. Significant efforts have been made to increase awareness of the risks associated with tamsulosin, and educational initiatives have fostered the uptake of technical adjustments to decrease adverse event rates among tamsulosin-exposed patients. However, the effectiveness of these efforts at the population level has not been studied. Design Population-based study to evaluate cataract surgical adverse event rates over time among patients exposed to tamsulosin and those not exposed to this drug. Participants All male patients 66 years of age and older undergoing cataract surgery in Ontario, Canada, between January 1, 2003, and December 31, 2013, were included in the study. Methods Linked healthcare databases were used to study the evolution in the risk of cataract surgical adverse events over time among tamsulosin-exposed and non–tamsulosin-exposed patients adjusting for patient-, surgeon-, and institution-level covariates. The study timeframe incorporated periods before and after the first reports of tamsulosin-associated IFIS. Main Outcome Measures Four important cataract surgical adverse events were evaluated: posterior capsule rupture, dropped lens fragments, retinal detachment, and suspected endophthalmitis. Results Among patients exposed to tamsulosin, the risk of surgical adverse events decreased over time (odds ratio, 0.95 per year; 95% confidence interval, 0.91–0.99 per year). This trend was observed across patient age strata. Among patients not recently exposed to tamsulosin, the risk of surgical adverse events also decreased over time (odds ratio, 0.96 per year; 95% confidence interval, 0.95–0.98 per year). Conclusions The risk of cataract surgical complications among both tamsulosin-exposed and non–tamsulosin-exposed patients declined between 2003 and 2013. Tamsulosin remains an important risk factor for cataract surgical adverse events, and ongoing efforts will be needed to develop and disseminate surgical approaches that mitigate the risks posed by tamsulosin.

OBJECTIVES Antimicrobial stewardship is advocated to reduce antimicrobial resistance in ICUs by reducing unnecessary antimicrobial consumption. Evidence has been limited to short, single-center studies. We evaluated whether antimicrobial stewardship in ICUs could reduce antimicrobial consumption and costs. DESIGN We conducted a phased, multisite cohort study of a quality improvement initiative. SETTING Antimicrobial stewardship was implemented in four academic ICUs in Toronto, Canada beginning in February 2009 and ending in July 2012. PATIENTS All patients admitted to each ICU from January 1, 2007, to December 31, 2015, were included. INTERVENTIONS Antimicrobial stewardship was delivered using in-person coaching by pharmacists and physicians three to five times weekly, and supplemented with unit-based performance reports. Total monthly antimicrobial consumption (measured by defined daily doses/100 patient-days) and costs (Canadian dollars/100 patient-days) before and after antimicrobial stewardship implementation were measured. MEASUREMENTS AND MAIN RESULTS A total of 239,123 patient-days (57,195 patients) were analyzed, with 148,832 patient-days following introduction of antimicrobial stewardship. Antibacterial use decreased from 120.90 to 110.50 defined daily dose/100 patient-days following introduction of antimicrobial stewardship (adjusted intervention effect -12.12 defined daily dose/100 patient-days; 95% CI, -16.75 to -7.49; p < 0.001) and total antifungal use decreased from 30.53 to 27.37 defined daily doses/100 patient-days (adjusted intervention effect -3.16 defined daily dose/100 patient-days; 95% CI, -8.33 to 0.04; p = 0.05). Monthly antimicrobial costs decreased from $3195.56 to $1998.59 (adjusted intervention effect -$642.35; 95% CI, -$905.85 to -$378.84; p < 0.001) and total antifungal costs were unchanged from $1771.86 to $2027.54 (adjusted intervention effect -$355.27; 95% CI, -$837.88 to $127.33; p = 0.15). Mortality remained unchanged, with no consistent effects on antimicrobial resistance and candidemia. CONCLUSIONS Antimicrobial stewardship in ICUs with coaching plus audit and feedback is associated with sustained improvements in antimicrobial consumption and cost. ICUs with high antimicrobial consumption or expenditure should consider implementing antimicrobial stewardship programs.

BACKGROUND: Guidance from randomized clinical trials about the ongoing benefits of statin therapies in residents of long-term care facilities is lacking. We sought to examine the effect of statin dose on 1-year survival and admission to hospital for cardiovascular events in this setting. METHODS: We conducted a retrospective cohort study using population-based administrative data from Ontario, Canada. We identified 21 808 residents in long-term care facilities who were 76 years of age and older and were prevalent statin users on the date of a full clinical assessment between April 2013 and March 2014, and categorized residents as intensive- or moderate-dose users. Treatment groups were matched on age, sex, admission to hospital for atherosclerotic cardiovascular disease, resident frailty and propensity score. Differences in 1-year survival and admission to hospital for cardiovascular events were measured using Cox proportional and subdistribution hazard models, respectively. RESULTS: Using propensity-score matching, we included 4577 well-balanced pairs of residents who were taking intensive- and moderate-dose statins. After 1 year, there were 1210 (26.4%) deaths and 524 (11.5%) admissions to hospital for cardiovascular events among residents using moderate-dose statins compared with 1173 (25.6%) deaths and 522 (11.4%) admissions to hospital for cardiovascular events among those taking intensive-dose statins. We found no significant association between prevalent use of intensive-dose statins and 1-year survival (hazard ratio [HR] 0.97, 95% confidence interval [CI] 0.90 to 1.05) or 1-year admission to hospital for cardiovascular events (HR 0.99, 95% CI 0.88 to 1.12) compared with use of moderate-dose statins. INTERPRETATION: The rates of mortality and admission to hospital for cardiovascular events at 1 year were similar between residents in long-term care taking intensive-dose statins compared with those taking moderate-dose statins. This lack of benefit should be considered when prescribing statins to vulnerable residents of long-term care facilities who are at potentially increased risk of statin-related adverse events.

Background Patients who receive palliative care are less likely to die in hospital. Objective To measure the association between physician rates of referral to palliative care and location of death in hospitalized adults with serious illness. Research design Population-based decedent cohort study using linked health administrative data in Ontario, Canada. Subjects A total of 7866 physicians paired with 130,862 hospitalized adults in their last year of life who died of serious illness between 2010 and 2016. Exposure Physician annual rate of referral to palliative care (high, average, low). Measures Odds of death in hospital versus home, adjusted for patient characteristics. Results There was nearly 4-fold variation in the proportion of patients receiving palliative care during follow-up based on attending physician referral rates: high 42.4% (n=24,433), average 24.7% (n=10,772), low 10.7% (n=6721). Referral to palliative care was also associated with being referred by palliative care specialists and in urban teaching hospitals. The proportion of patients who died in hospital according to physician referral rate were 47.7% (high), 50.1% (average), and 52.8% (low). Hospitalized patients cared for by a physician who referred to palliative care at a high rate had lower risk of dying in hospital than at home compared with patients who were referred by a physician with an average rate of referral [adjusted odds ratio 0.91; 95% confidence interval, 0.86-0.95; number needed to treat=57 (interquartile range 41-92)] and by a physician with a low rate of referral [adjusted odds ratio 0.81; 95% confidence interval, 0.77-0.84; number needed to treat =28 patients (interquartile range 23-44)]. Conclusions and relevance An attending physicians' rates of referral to palliative care is associated with a lower risk of dying in hospital. Therefore, patients who are cared for by physicians with higher rates of referral to palliative care are less likely to die in hospital and more likely to die at home. Standardizing referral to palliative care may help reduce physician-level variation as a barrier to access.

Objective: To estimate the bias associated with specific nonrandomized study attributes among studies comparing transcatheter aortic valve implantation with surgical aortic valve replacement for the treatment of severe aortic stenosis.Data sources and study selection: We searched 7 databases from inception to June 2017: Medline, Medline In-Process/ePubs, Embase, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Scopus, and Web of Science. We included all RCTs and nonrandomized studies that reported outcomes of interest.Data extraction and synthesis: We categorized studies according to study design, and evaluated 41 nonrandomized study attributes as potential sources of bias. We calculated odds ratios (OR) and other effect measures with 95% confidence intervals (CI) using random effects models.Main outcomes: One month postoperative mortality, and length of stay. Bias was defined as the difference in estimates of treatment effects between nonrandomized studies and high quality (low risk of bias) RCTs, which were considered to provide “gold standard” estimates.Results: We included 6 RCTs and 87 nonrandomized studies. Surgical risk scores were similar for comparison groups in RCTs, but were higher for patients having transcatheter aortic valve implantation in nonrandomized studies. Nonrandomized studies underestimated the benefit of transcatheter aortic valve implantation compared with RCTs. For example, nonrandomized studies without adjustment estimated a higher risk of postoperative mortality for transcatheter aortic valve implantation compared with surgical aortic valve replacement (OR 1.43 [95% CI, 1.26 to 1.62]) than high quality RCTs (OR 0.78 [95% CI, 0.54 to 1.11). Nonrandomized studies using propensity score matching (OR 1.13 [95% CI, 0.85 to 1.52]) and regression modelling (OR 0.68 [95% CI, 0.57 to 0.81]) to adjust results estimated treatment effects closer to high quality RCTs. Nonrandomized studies describing losses to follow-up estimated treatment effects that were significantly closer to high quality RCT than nonrandomized studies that did not.Conclusion: Studies with different attributes produce different estimates of treatment effects. Study design attributes related to the completeness of follow-up may explain biased treatment estimates in nonrandomized studies, as in the case of aortic valve replacement where high-risk patients were preferentially selected for the newer (transcatheter) procedure.

INTRODUCTION Several differences have been reported between male and female patients with stroke in clinical and sociodemographic features, treatment, and outcomes. Potential effects in the inpatient rehabilitation population are unclear. OBJECTIVE To evaluate the differences between male and female patients in discharge functional status, length of stay, and discharge home after inpatient rehabilitation for stroke. DESIGN Retrospective, population-based cohort study. SETTING Inpatient rehabilitation centers in Ontario, Canada. PARTICIPANTS Male (N = 10,684) and female (N = 9459) patients discharged from acute care between September 1, 2012 and August 31, 2017, with a diagnosis of stroke and subsequently admitted to inpatient rehabilitation. EXPOSURE VARIABLE Female sex. MAIN OUTCOME MEASURES Discharge Functional Independence Measure (FIM) score, length of stay, and discharge home. RESULTS Female patients had a lower functional status at discharge (mean FIM score 94.1 vs. 97.8, p

Key Points Question How is palliative care being delivered to patients with noncancer illness (ie, chronic organ failure and dementia), and is it being delivered differently than for patients with cancer? Findings In this cohort study, among 145 709 adults who died of cancer or terminal noncancer illness and received palliative care in their last year of life, palliative care was more likely to be initiated earlier, initiated in the hospital setting, and delivered across multiple care settings in patients with cancer than in those with organ failure or dementia. Patients with cancer were more likely to receive care using a consultative or specialist model instead of a generalist model and received palliative care more often from general practitioners and physicians with subspecialty training compared with patients with chronic organ failure or dementia. Meaning Differences in the delivery of palliative care across distinct types of serious illness have important implications for the organization and scaled implementation of palliative care programs, including enhancement of practitioner education and training and improvements in equitable access to care across all settings., Importance Palliative care improves health outcomes, but studies of the differences in the delivery of palliative care to patients with different types of serious illness are lacking. Objective To examine the delivery of palliative care among adults in their last year of life who died of terminal noncancer illness compared with those who died of cancer. Design, Setting, and Participants This population-based cohort study used linked health administrative data of adults who received palliative care in their last year of life and died between January 1, 2010, and December 31, 2017, in Ontario, Canada. Exposures Cause of death (chronic organ failure, dementia, or cancer). Main Outcomes and Measures Components of palliative care delivery, including timing and location of initiation, model of care, physician mix, care settings, and location of death. Results A total of 145 709 adults received palliative care (median age, 78 years; interquartile range, 67-86 years; 50.7% female); 21 054 died of chronic organ failure (4704 of heart failure, 5715 of chronic obstructive pulmonary disease, 3785 of end-stage kidney disease, 579 of cirrhosis, and 6271 of stroke), 14 033 died of dementia, and 110 622 died of cancer. Palliative care was initiated earlier (>90 days before death) in patients with cancer (32 010 [28.9%]) than in those with organ failure (3349 [15.9%]; absolute difference, 13.0%) or dementia (2148 [15.3%]; absolute difference, 13.6%). A lower proportion of patients with cancer had palliative care initiated in the home (16 088 [14.5%]) compared with patients with chronic organ failure (6904 [32.8%]; absolute difference, −18.3%) or dementia (3922 [27.9%]; absolute difference, −13.4%). Patients with cancer received palliative care across multiple care settings (92 107 [83.3%]) more often than patients with chronic organ failure (12 061 [57.3%]; absolute difference, 26.0%) or dementia (7553 [53.8%]; absolute difference, 29.5%). Palliative care was more often delivered to patients with cancer (80 615 [72.9%]) using a consultative or specialist instead of a generalist model compared with patients with chronic organ failure (9114 [43.3%]; absolute difference, 29.6%) or dementia (5634 [40.1%]; absolute difference, 32.8%). Patients with cancer (42 718 [38.6%]) received shared palliative care more often from general practitioners and physicians with subspecialty training, compared with patients with chronic organ failure (3599 [17.1%]; absolute difference, 21.5%) or dementia (1989 [14.2%]; absolute difference, 24.4%). Conclusions and Relevance In this cohort study, there were substantial patient- and practitioner-level differences in the delivery of palliative care across distinct types of serious illness. These patient- and practitioner-level differences have important implications for the organization and scaled implementation of palliative care programs, including enhancement of practitioner education and training and improvements in equitable access to care across all settings., This cohort study examines the delivery of palliative care among adults in their last year of life who died of terminal noncancer illness compared with those who died of cancer.

BACKGROUND: Neonatal intensive care is expensive and prolonged. Extremely preterm infants are routinely supported. The costs for this practice at the age of borderline viability are of interest to clinicians and policymakers. METHODS: We analyzed data from the Canadian national administrative database on total cost and length of hospital care from a public payor perspective for 23–28-week premature infants from 2011 to 2015. We also compared total and daily costs for 23–25-week newborns. Each comparison evaluated the total cohort and infants who lived more than 3 days. We used non-parametric tests, correlation tests, and generalized linear models for cost difference analysis, adjusting for survival, length of stay, and year. RESULTS: We analyzed 6,932 infants’ cost records. For all infants, median length of hospital stay was 41 days (IQR, 1–77 days). For infants who survived the first 3 days, median length of stay was 61 days (IQR, 34–90 days). The median total cost was $66,669 (IQR, $4,920–$125,550). For infants who survived the first 3 days, median total cost was $91,137 (IQR, $56,596–$188,757). For infants who survived the first 3 days, median total costs were $147,835 (IQR, $44,711–$233,847) for 23-week infants, $154,736 (IQR, $61,160–$248,290) for 24-week infants, and $130,317 (IQR, $79,737–$229,058) for 25-week infants. These amounts did not differ (P>0.7). CONCLUSIONS: Total and daily costs of neonatal intensive care are high. Total cost was not different between surviving 23–25-week infants. These findings highlight the need for a funding strategy for the routine support of these fragile infants.

IMPORTANCE: The evidence for palliative care exists predominantly for patients with cancer. The effect of palliative care on important end-of-life outcomes in patients with noncancer illness is unclear. OBJECTIVE: To measure the association between palliative care and acute health care use, quality of life (QOL), and symptom burden in adults with chronic noncancer illnesses. DATA SOURCES: MEDLINE, Embase, CINAHL, PsycINFO, and PubMed from inception to April 18, 2020. STUDY SELECTION: Randomized clinical trials of palliative care interventions in adults with chronic noncancer illness. Studies involving at least 50% of patients with cancer were excluded. DATA EXTRACTION AND SYNTHESIS: Two reviewers independently screened, selected, and extracted data from studies. Narrative synthesis was conducted for all trials. All outcomes were analyzed using random-effects meta-analysis. MAIN OUTCOMES AND MEASURES: Acute health care use (hospitalizations and emergency department use), disease-generic and disease-specific quality of life (QOL), and symptoms, with estimates of QOL translated to units of the Functional Assessment of Chronic Illness Therapy-Palliative Care scale (range, 0 [worst] to 184 [best]; minimal clinically important difference, 9 points) and symptoms translated to units of the Edmonton Symptom Assessment Scale global distress score (range, 0 [best] to 90 [worst]; minimal clinically important difference, 5.7 points). RESULTS: Twenty-eight trials provided data on 13 664 patients (mean age, 74 years; 46% were women). Ten trials were of heart failure (n = 4068 patients), 11 of mixed disease (n = 8119), 4 of dementia (n = 1036), and 3 of chronic obstructive pulmonary disease (n = 441). Palliative care, compared with usual care, was statistically significantly associated with less emergency department use (9 trials [n = 2712]; 20% vs 24%; odds ratio, 0.82 [95% CI, 0.68-1.00]; I(2) = 3%), less hospitalization (14 trials [n = 3706]; 38% vs 42%; odds ratio, 0.80 [95% CI, 0.65-0.99]; I(2) = 41%), and modestly lower symptom burden (11 trials [n = 2598]; pooled standardized mean difference (SMD), −0.12; [95% CI, −0.20 to −0.03]; I(2) = 0%; Edmonton Symptom Assessment Scale score mean difference, −1.6 [95% CI, −2.6 to −0.4]). Palliative care was not significantly associated with disease-generic QOL (6 trials [n = 1334]; SMD, 0.18 [95% CI, −0.24 to 0.61]; I(2) = 87%; Functional Assessment of Chronic Illness Therapy-Palliative Care score mean difference, 4.7 [95% CI, −6.3 to 15.9]) or disease-specific measures of QOL (11 trials [n = 2204]; SMD, 0.07 [95% CI, −0.09 to 0.23]; I(2) = 68%). CONCLUSIONS AND RELEVANCE: In this systematic review and meta-analysis of randomized clinical trials of patients with primarily noncancer illness, palliative care, compared with usual care, was statistically significantly associated with less acute health care use and modestly lower symptom burden, but there was no significant difference in quality of life. Analyses for some outcomes were based predominantly on studies of patients with heart failure, which may limit generalizability to other chronic illnesses.

BackgroundRegional variation in cost of neonatal intensive care for extremely preterm infant is not documented. We sought to evaluate regional variation that may lead to benchmarking and cost saving.MethodsAn analysis of a Canadian national costing data from the payor perspective. We included all liveborn 23–28-week preterm infants in 2011–2015. We calculated variation in costs between provinces using non-parametric tests and a generalized linear model to evaluate cost variation after adjustment for gestational age, survival, and length of stay.ResultsWe analysed 6932 infant records. The median total cost for all infants was $66,668 (Inter-Quartile Range (IQR): $4920–$125,551). Medians for the regions varied more than two-fold and ranged from $48,144 in Ontario to $122,526 in Saskatchewan. Median cost for infants who survived the first 3 days of life was $91,000 (IQR: $56,500–$188,757). Median daily cost for all infants was $1940 (IQR: $1518–$2619). Regional variation was significant after adjusting for survival more than 3 days, length of stay, gestational age, and year (pseudo-R2 = 0.9,p ConclusionCosts of neonatal intensive care are high. There is large regional variation that persists after adjustment for length of stay and survival. Our results can be used for benchmarking and as a target for focused cost optimization, savings, and investment in healthcare.

Background Traditional discharge processes lack a patient-centred focus. This project studied the implementation and effectiveness of an individualized discharge tool across Ontario hospitals. The Patient Oriented Discharge Summary (PODS) is an individualized discharge tool with guidelines that was co-designed with patients and families to enable a patient-centred process. Methods Twenty one acute-care and rehabilitation hospitals in Ontario, Canada engaged in a community of practice and worked over a period of 18 months to implement PODS. An effectiveness-implementation hybrid design using a triangulation approach was used with hospital-collected data, patient and provider surveys, and interviews of project teams. Key outcomes included: penetration and fidelity of the intervention, change in patient-centred processes, patient and provider satisfaction and experience, and healthcare utilization. Statistical methods included linear mixed effects models and generalized estimating equations. Results Of 65,221 discharges across hospitals, 41,884 patients (64%) received a PODS. There was variation in reach and implementation pattern between sites, though none of the between site covariates was significantly associated with implementation success. Both high participation in the community of practice and high fidelity were associated with higher penetration. PODS improved family involvement during discharge teaching (7% increase, p = 0.026), use of teach-back (11% increase, p p = 0.041). Although unscheduled healthcare utilization decreased with PODS implementation, it was not statistically significant. Conclusions This project highlighted the system-wide adaptability and ease of implementing PODS across multiple patient groups and hospital settings. PODS demonstrated an improvement in patient-centred discharge processes linked to quality standards and health outcomes. A community of practice and high quality content may be needed for successful implementation.

Objectives:Antibiotics are commonly used in intensive care units (ICUs), yet differences in antibiotic use across ICUs are unknown. Herein, we studied antibiotic use across ICUs and examined factors that contributed to variation.Methods:We conducted a retrospective cohort study using data from Ontario’s Critical Care Information System (CCIS), which included 201 adult ICUs and 2,013,397 patient days from January 2012 to June 2016. Antibiotic use was measured in days of therapy (DOT) per 1,000 patient days. ICU factors included ability to provide ventilator support (level 3) or not (level 2), ICU type (medical-surgical or other), and academic status. Patient factors included severity of illness using multiple-organ dysfunction score (MODS), ventilatory support, and central venous catheter (CVC) use. We analyzed the effect of these factors on variation in antibiotic use.Results:Overall, 269,351 patients (56%) received antibiotics during their ICU stay. The mean antibiotic use was 624 (range 3–1460) DOT per 1,000 patient days. Antibiotic use was significantly higher in medical-surgical ICUs compared to other ICUs (697 vs 410 DOT per 1,000 patient days; P < .0001) and in level 3 ICUs compared to level 2 ICUs (751 vs 513 DOT per 1,000 patient days; P < .0001). Higher antibiotic use was associated with higher severity of illness and intensity of treatment. ICU and patient factors explained 47% of the variation in antibiotic use across ICUs.Conclusions:Antibiotic use varies widely across ICUs, which is partially associated with ICUs and patient characteristics. These differences highlight the importance of antimicrobial stewardship to ensure appropriate use of antibiotics in ICU patients.

Background Palliative care is associated with improved symptom control and quality of life in people with heart failure. There is conflicting evidence as to whether it is associated with a greater likelihood of death at home in this population. The objective of this study was to describe the delivery of newly initiated palliative care services in adults who die with heart failure and measure the association between receipt of palliative care and death at home compared with those who did not receive palliative care. Methods and Results We performed a population‐based cohort study using linked health administrative data in Ontario, Canada of 74 986 community‐dwelling adults with heart failure who died between 2010 and 2015. Seventy‐five percent of community‐dwelling adults with heart failure died in a hospital. Patients who received any palliative care were twice as likely to die at home compared with those who did not receive it (adjusted odds ratio 2.12 [95% CI , 2.03–2.20]; P CI , 9.34–15.11]; P CI , 6.41–10.27]; P Conclusions Most adults with heart failure die in a hospital. Providing palliative care near the end‐of‐life was associated with an increased likelihood of dying at home. These findings suggest that scaling existing palliative care programs to increase access may improve end‐of‐life care in people dying with chronic noncancer illness.

The overuse of antimicrobials in primary care can be linked to an increased risk of antimicrobial-resistant bacteria for individual patients. Although there are promising signs of the benefits associated with Antimicrobial Stewardship Programs (ASPs) in hospitals and long-term care settings, there is limited knowledge in primary care settings and how to implement ASPs in these settings is unclear. In this context, a qualitative study was undertaken to explore the perceptions of primary care prescribers of the usefulness, feasibility, and experiences associated with the implementation of a pilot community-focused ASP intervention in three primary care clinics. Qualitative interviews were conducted with primary care clinicians, including local ASP champions, prescribers, and other primary health care team members, while they participated in an ASP initiative within one of three primary care clinics. An iterative conventional content analyses approach was used to analyze the transcribed interviews. Themes emerged around the key enablers and barriers associated with ASP implementation. Study findings point to key insights relevant to the scalability of community ASP activities with primary care providers.

Background Most dementia care occurs in the community with support from informal caregivers who are often distressed. Dementia caregiver distress is known to be hazardous to the caregiver's health, but the impact on the dementia care recipient is not well known. Methods We searched the Medline, Embase, PsycINFO, CINAHL, and Cochrane databases from inception until June 2017 for studies investigating the association of informal caregiver distress with health outcomes of community-dwelling dementia care recipients. The search results were screened and then data abstracted, and the risk of bias was appraised independently by pairs of reviewers. Results We included 81 original investigations (n = 43 761 caregivers and dementia care recipients). Sixty-six studies (81.5%) were observational or cross-sectional in design, and 47 studies (58%) had a low risk of bias. There was considerable clinical and methodological heterogeneity precluding quantitative synthesis. Dementia care recipients (n = 21 881) had a mean age of 78.2 years (SD ± 3.8 y), half (50.0%) were women, and two-thirds (66.1%) had Alzheimer's disease. The dementia caregivers (n = 21 880) had a mean age of 62.5 years (SD ± 23.3), three-quarters (74.1%) were women, and one-half (50.5%) were spouses of the dementia care recipient. Twenty-two unique dementia care recipient outcomes were studied including cognition, mood, quality of life, function, healthcare utilization, and costs. Overall, informal caregiver distress is commonly associated with the institutionalization of the dementia care recipient, worsening behavioral and psychological symptoms of dementia, and experiencing elder abuse. Conclusion Informal caregiving is a cornerstone of dementia care, and distress related to this role is associated with worsening of several dementia care recipient health outcomes. It is important that clinicians and researchers worldwide consider the broader consequences of caregiver distress. J Am Geriatr Soc 67:609-617, 2019.

Background: Staphylococcus aureus bacteremia (SAB) results in high morbidity and mortality. Infectious diseases (ID) consultation for SAB has been associated with improved process measures and outcomes in SAB. Recent guidelines have been implemented to include ID consultation in the management of positive SAB culture. We sought to determine whether a policy of mandatory ID consultation for SAB would improve management and mortality. Methods: We conducted a retrospective quasi-experimental study of patients with SAB at three academic hospitals comparing adherence to process measures, and mortality as a secondary measure, before and after implementation of a hospital policy of mandatory ID consultation for all cases of SAB. Results: ID consultation was performed in 239/411 (58%) patients in the pre-intervention period and 196/205 (96%) patients in the post-intervention period (p < 0.0001). Compared with pre-intervention, mandatory consultation was associated with better adherence to quality process measures including echocardiography (319/411 (78%) versus 186/205 (91%) p < 0.0001), subsequent blood culture within 2–4 days (174/411 (42%) versus 143/205 (70%) p < 0.0001) and avoidance of vancomycin as definitive antibiotic therapy for methicillin-susceptible S. aureus (MSSA) (54/347 (16%) versus 13/177 (7%) p = 0.0082). In-hospital mortality rate was 94/411 (23%) in the pre-intervention group and 33/205 (16%) in the post-intervention group. The unadjusted sub-distribution hazard ratio (sHR) for in-hospital mortality in the postintervention period was 0.67 (95% CI 0.45 to 0.99, p = 0.0447). After adjusting for significant prognostic factors, post-intervention in-hospital mortality had an sHR of 0.79 (95% CI 0.52 to 1.20, p = 0.2686). Conclusions: A policy of mandatory ID consultation for patients with SAB was easily implemented leading to consultation in nearly all SAB patients and improved adherence to standard of care process measures. In-hospital mortality did not improve significantly after adjusting for patient characteristics. Our study provides the framework to support this easily implemented institutional policy in academic hospitals.

Purpose To determine whether patients with severe acute kidney injury who receive dialysis (AKI-D) experience better outcomes at centres that care for more patients with AKI-D. Materials and methods Linked administrative datasets where used to perform a retrospective cohort study of all critically ill patients in Ontario, Canada, who had a first episode of AKI-D between 2002 and 2011. Centre volume for a given year, was designated by calculating the mean number of patients treated with acute dialysis at that centre during that year and the one preceding it. Patients treated at that centre were then assigned to a centre volume quartile for that year. Results We identified 19,658 critically ill patients with AKI-D treated at 54 Ontario hospitals. Mortality and dialysis dependence at 90-days were 46% and 31%, respectively. Centre volume was not associated with mortality at 90 days (with quartile 1 as the reference, adjusted odds ratio (aOR) 1.16 (95% CI, 0.87 - 1.54) in quartile 2, aOR 1.17 (95% CI, 0.91 - 1.50) in quartile 3, and aOR 1.06 (95% CI, 0.81 - 1.41) in quartile 4). Conclusions There are no Centre volume survival associations in the management of AKI-D despite high mortality and dependence rate.

Background Mediation analysis tests whether the relationship between two variables is explained by a third intermediate variable. We sought to describe the usage and reporting of mediation analysis with time-to-event outcomes in published healthcare research. Methods A systematic search of Medline, Embase, and Web of Science was executed in December 2016 to identify applications of mediation analysis to healthcare research involving a clinically relevant time-to-event outcome. We summarized usage over time and reporting of important methodological characteristics. Results We included 149 primary studies, published from 1997 to 2016. Most studies were published after 2011 (n = 110, 74%), and the annual number of studies nearly doubled in the last year (from n = 21 to n = 40). A traditional approach (causal steps or change in coefficient) was most commonly taken (n = 87, 58%), and the majority of studies (n = 114, 77%) used a Cox Proportional Hazards regression for the outcome. Few studies (n = 52, 35%) mentioned any of the assumptions or limitations fundamental to a causal interpretation of mediation analysis. Conclusion There is increasing use of mediation analysis with time-to-event outcomes. Current usage is limited by reliance on traditional methods and the Cox Proportional Hazards model, as well as low rates of reporting of underlying assumptions. There is a need for formal criteria to aid authors, reviewers, and readers reporting or appraising such studies. Electronic supplementary material The online version of this article (10.1186/s12874-018-0578-7) contains supplementary material, which is available to authorized users.

Objectives To evaluate whether risk of fall‐related injuries differs between nursing home (NH) residents newly dispensed low‐dose trazodone and those newly dispensed benzodiazepines. Design Retrospective, matched cohort study in linked, population‐based administrative data. Matching was based on propensity score ( ± 0.2 standard deviations of the score as a caliper), age ( ± 1 year), sex, frailty status, and history of dementia. The derived propensity score included demographic characteristics, clinical comorbidities, cognitive and functional status, and risk factors for falls. Setting All NHs in Ontario, Canada. Participants Propensity score–matched pairs of residents aged 66 and older who received a full clinical assessment between April 1, 2010, and March 31, 2015 (N=7,791). Measurements Hospitalization (emergency department visit or acute care admission) for a fall‐related injury within 90 days of exposure. Subdistribution hazard functions accounted for competing risk of death. Sensitivity analyses were used to examine falls resulting in hip or wrist fracture only, as well as different lengths of follow‐up at 30, 60, and 180 days. Results Cumulative incidence of a fall‐related injury in the 90 days after index was 5.7% for low‐dose trazodone users and 6.0% for benzodiazepine users (between‐group change=–0.29, 95% confidence interval (CI)=–1.02–0.44]; hazard ratio=0.94, 95% CI=0.83–1.08). Findings were consistent across sensitivity analyses. Conclusion New use of low‐dose trazodone was no safer with respect to a risk of a fall‐related injury than new use of benzodiazepines. Additional studies to compare the effectiveness and risks of low‐dose trazodone with those of a variety of psychotropic drug therapies are required in light of increasing trends in the use of trazodone in NHs.

Objectives To examine dose‐related prescribing and short‐term serious events associated with initiation of cholinesterase inhibitor (ChEI) therapy. Design Retrospective, population‐based cohort study. Setting Ontario, Canada. Participants Women (n=47,829) and men (n=32,503) aged 66 and older who initiated a ChEI between April 1, 2010, and June 30, 2016. Measurements All‐cause serious events (emergency department (ED) visits, inpatient hospitalizations, death) within 30 days of ChEI initiation. Multivariable Cox proportional hazards models were used to estimate adjusted rates of serious events. Results Overall, 4.8% of older adults were dispensed a lower‐than‐recommended ChEI starting dose, 87.9% a recommended dose, and 7.3% a higher‐than‐recommended starting dose. Eight thousand six hundred seventy‐one (10.8%) individuals experienced a serious event within 30 days of initiating therapy, primarily ED visits (8,540, 10.6%). Relative to those initiated on a recommended starting dose, those initiated on a higher dose had a significantly increased rate of serious events (women adjusted hazard ratio (aHR) 1.50, 95% confidence interval (CI) =1.38–1.63; men aHR 1.31, 95% CI=1.19–1.45). Similar patterns were found for ED visits and inpatient hospitalizations but not death. The relative effect of higher‐than‐recommended starting dose dispensed vs. recommended starting dose dispensed was greater in women than it was in men: the number needed to harm was 22 (95% confidence interval (CI)=18–29) for women and 36 (95% CI= 26–61) for men. Conclusion Serious events immediately after initiation of ChEIs were associated with starting ChEI dose. This association was stronger in women.

Laparoscopic adjustable gastric band (LAGB) placement remains a common bariatric procedure. While LAGB procedure is performed within private clinics in most Canadian provinces, public health care is often utilized for LAGB-related reoperations. We identified 642 gastric band removal procedures performed in Ontario from 2011 to 2014 using population-level administrative data. The number of procedures performed increased annually from 101 in 2011 to 220 in 2014. Notably, 54.7% of the patients required laparotomy, and 17.6% of patients underwent a subsequent bariatric surgery. Our findings demonstrated that LAGB placement in private clinics resulted in a large number of band removal procedures performed within the public system. This represents a significant public health concern that may result in significant health care utilization and patient morbidity.

Purpose A mapping review to quantify representation of vulnerable populations, who suffer from disparity and often inequitable healthcare, in quality improvement (QI) research. Data sources Studies published in 2004-2014 inclusive from Medline, Embase and Cochrane databases for English language research with the terms 'quality improvement' or 'quality control' or 'QI' and 'plan-do-study-act' or 'PDSA' in the years 2004-2014 inclusively. Study selection Published clinical research that was a QI-themed, as identified by its declared search terms, MESH terms, abstract or title. Data extraction Three reviewers identified the eligible studies independently. Excluded were publications that were not trials, evaluations or analyses. Results of data synthesis Of 2039 results, 1660 were eligible for inclusion. There were 586 (33.5%) publications that targeted a specific vulnerable population: children (184, 10.54%), mental health patients (125, 7.16%), the elderly (100, 5.73%), women (57, 3.27%), the poor (30, 1.72%), rural residents (29, 1.66%), visible minorities (27, 1.55%), the terminally ill (17, 0.97%), adolescents (16, 0.92%) and prisoners (1 study). Seventy-four articles targeted two or more vulnerable populations, and 11 targeted three population categories. On average, there were 158 QI research studies published per year, increasing from 69 in 2004 to 396 in 2014 (R2 = 0.7, P < 0.001). The relative representation of vulnerable populations had a mean of 33.58% and was stable over the time period (standard deviation (SD) = 5.9%, R2 = 0.001). Seven countries contributed to over 85% of the publications targeting vulnerable populations, with the USA contributing 62% of the studies. Conclusions Over 11 years, there has been a marked increase in QI publications. Roughly one-third of all published QI research is on vulnerable populations, a stable proportion over time. Nevertheless, some vulnerable populations are under-represented. Increased education, resources and attention are encouraged to improve the health of vulnerable populations through focused QI initiatives.

Objectives We conducted a meta-analysis to summarize diagnostic properties of risk factors and clinical prediction rules for diagnosing infective endocarditis (IE) in Staphylococcus aureus bacteraemia (SAB). Methods We searched MEDLINE, Embase, and the Cochrane Database from inception to 6 January 2016 to identify studies evaluating risk factors and clinical prediction rules for IE in SAB patients. Pooled estimates of diagnostic properties for main risk factors were calculated using a bivariate random effects model. Results Of 962 articles identified, 30 studies were included. These involved 16 538 SAB patients including 1572 IE cases. Risk factors with positive likelihood ratio (PLR) greater than 5 included embolic events (PLR 12.7, 95% CI 9.2–17.7), pacemakers (PLR 9.7, 95% CI 3.7–21.2), history of previous IE (PLR 8.2, 95% CI 3.1–22.0), prosthetic valves (PLR 5.7, 95% CI 3.2–9.5), and intravenous drug use (PLR 5.2, 95% CI 3.8–6.9). The only clinical factor with negative likelihood ratio (NLR) less than 0.5 was documented clearance of bacteraemia within 72 hours (NLR range 0.32–0.35). Of the nine published clinical prediction rules for ruling out IE, five had an NLR below 0.1. Conclusions SAB patients with high-risk features (embolic events, pacemakers, prosthetic valves, previous IE, or intravenous drug use) should undergo a trans-esophageal echocardiography (TEE) for IE. Clinical prediction rules show promise in safely ruling out endocarditis, but require validation in future studies.

ObjectiveTo compare inhospital mortality of general internal medicine (GIM) patients bedspaced to off-service wards with GIM inpatients admitted to assigned GIM wards.MethodA retrospective cohort study of consecutive GIM admissions between 1 January 2015 and 1 January 2016 was conducted at a large tertiary care hospital in Canada.Inhospital mortality was compared between patients admitted to off-service wards (bedspaced) and assigned GIM wards using a Cox proportional hazards model and a competing risk model. Sensitivity analyses included propensity score and pair matching based on GIM service team, workload, demographics, time of admission, reasons for admission and comorbidities.ResultsAmong 3243 consecutive GIM admissions, more than a third (1125, 35%) were bedspaced to off-service wards with the rest (2118, 65%) admitted to assigned GIM wards. In hospital, 176 (5%) patients died: 88/1125 (8%) bedspaced patients and 88/2118 (4%) assigned GIM ward patients. Compared with assigned GIM wards patients, bedspaced patients had an HR of 3.42 (95% CI 2.23 to 5.26; PConclusionsBedspaced patients had significantly higher inhospital mortality than patients admitted to assigned GIM wards. The risk was highest at admission and subsequently declined. The results of this single centre study may not be generalisable to other hospitals and may be influenced by residual confounding. Despite these limitations, the relationship between bedspacing and patient outcomes requires investigation at other institutions to determine if this common practice represents a modifiable patient safety indicator.

Background Polypharmacy in hemodialysis patients can result in adverse patient outcomes. Deprescribing tools can reduce polypharmacy, yet no method exists for an outpatient hemodialysis population. Design Quality improvement study. Setting & Participants 240 patients in a tertiary-care outpatient hemodialysis unit. Quality Improvement Plan We aimed to: (1) develop a deprescribing tool for target medications with poor evidence for efficacy and safety, (2) determine its effectiveness in decreasing polypharmacy, and (3) monitor patient safety and satisfaction. Outcomes The primary outcome was the proportion of target medications completely deprescribed after 4 weeks. Secondary outcomes were the proportion of target medications completely deprescribed after 6 months, average number of medications per patient before and after deprescription, and proportion of successful deprescriptions for each target medication. Measurements Number of medications deprescribed at 4 weeks and 6 months. Patient safety and satisfaction were monitored using drug-specific monitoring parameters. Results A deprescribing tool for specific medications was developed and implemented in the hemodialysis unit. 5 medication classes were selected: quinine, diuretics, α 1 -blockers, proton pump inhibitors, and 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors (statins). All 240 patients in the unit were screened using the deprescribing tool. There were 171 of 240 (71%) patients prescribed at least 1 of the 5 target medications, and after applying the tool, 35 of 40 (88%) eligible patients had the medications deprescribed. There were 31 of 40 (78%) target medications completely deprescribed. 6 months after the study, only 5 of 31 (16%) medications discontinued were represcribed. At the end of the study, 57% of patients were taking fewer medications than at baseline. No adverse events were observed. Limitations Single-center study that relied on patient self-reporting of medication use and adherence to our recommendations. Conclusions Deprescribing tools can be applied successfully in an outpatient hemodialysis unit to reduce polypharmacy while maintaining patient safety and satisfaction.

BACKGROUND: Timely follow-up after hospital discharge may decrease readmission to hospital. Financial incentives to improve follow-up have been introduced in the United States and Canada, but it is unknown whether they are effective. Our objective was to evaluate the impact of an incentive program on timely physician follow-up after hospital discharge. METHODS: We conducted an interventional time series analysis of all medical and surgical patients who were discharged home from hospital between Apr. 1, 2002, and Jan. 30, 2015, in Ontario, Canada. The intervention was a supplemental billing code for physician follow-up within 14 days of discharge from hospital, introduced in 2006. The primary outcome was an outpatient visit within 14 days of discharge. Secondary outcomes were 7-day follow-up and a composite of emergency department visits, nonelective hospital readmission and death within 14 days. RESULTS: We included 8 008 934 patient discharge records. The incentive code was claimed in 31% of eligible visits by 51% of eligible physicians, and cost $17.5 million over the study period. There was no change in the average monthly rate of outcomes in the year before the incentive was introduced compared with the year following introduction: 14-day follow-up (66.5% v. 67.0%, overall p = 0.5), 7-day follow-up (44.9% v. 44.9%, overall p = 0.5) and composite outcome (16.7% v. 16.9%, overall p = 0.2). INTERPRETATION: Despite uptake by physicians, a financial incentive did not alter follow-up after hospital discharge. This lack of effect may be explained by features of the incentive or by extra-physician barriers to follow-up. These barriers should be considered by policymakers before introducing similar initiatives.

Background Antimicrobial prescribing is frequently reported as appropriate or inappropriate, particularly in the ICU. However, the definitions used are non-standardized and lack validity and reliability. Objectives To develop standardized definitions of appropriateness for antimicrobial prescribing in the critical care setting. Methods We used consensus-based modified Delphi and RAND appropriateness methodology to develop criteria to define appropriateness of antimicrobial prescribing. A multiphased approach with an online questionnaire followed by a facilitated in-person meeting was utilized and included clinicians from a variety of practice areas (e.g. surgeons, infectious diseases specialists, intensivists, transplant specialists and pharmacists). Results There were a total of 23 criteria agreed upon to define the following categories of antimicrobial prescribing: appropriate; effective but unnecessary; inappropriate; and under-treatment. Conclusions These standardized criteria for appropriateness may be generalizable to other patient populations and utilized with other tools to adjudicate prescribing practices.

Background and objectives Quality improvement interventions have enhanced care for other chronic illnesses, but their effectiveness for patients with CKD is unknown. We sought to determine the effects of quality improvement strategies on clinical outcomes in adult patients with nondialysis-requiring CKD. Design, setting, participants, & measurements We conducted a systematic review of randomized trials, searching Medline and the Cochrane Effective Practice and Organization of Care database from January of 2003 to April of 2015. Eligible studies evaluated one or more of 11 prespecified quality improvement strategies, and prespecified study outcomes included at least one process of care measure, surrogate outcome, or hard clinical outcome. We used a random effects model to estimate the pooled risk ratio (RR; dichotomous data) or the mean difference (continuous data). Results We reviewed 15 patient-level randomized trials (n=3298 patients), and six cluster-randomized trials (n=30,042 patients). Quality improvement strategies reduced dialysis incidence (seven trials; RR, 0.85; 95% confidence interval [95% CI], 0.74 to 0.97) and LDL cholesterol concentrations (four trials; mean difference, −17.6 mg/dl; 95% CI, −28.7 to −6.5), and increased the likelihood that patients received renin-angiotensin-aldosterone system inhibitors (nine trials; RR, 1.16; 95% CI, 1.06 to 1.27). We did not observe statistically significant effects on mortality, cardiovascular events, eGFR, glycated hemoglobin, and systolic or diastolic BP. Conclusions Quality improvement interventions yielded significant beneficial effects on three elements of CKD care. Estimates of the effectiveness of quality improvement strategies were limited by study number and adherence to quality improvement principles. Podcast This article contains a podcast at https://www.asn-online.org/media/podcast/CJASN/2017_09_06_CJASNPodcast_17_10.mp3

Objectives To examine the variability of statin use among nursing home residents and prescribing physicians, and to assess statin use by resident frailty. Design Population-based, cross-sectional analysis. Setting All nursing home facilities (N = 631) in Ontario, Canada between April 1, 2013 and March 31, 2014. Participants All adults aged 66 years and older who received a full clinical assessment while residing in a nursing home facility and their assigned, most responsible, physician. Measurements Statin use on date of clinical assessment. Resident- and physician-level characteristics ascertained through clinical assessment and health administrative data. Resident frailty was derived using a previously validated index. Results Among 76,226 nursing home residents assigned to 1,919 physicians, 25,648 (33.6%) were statin users. There were 13,331 (30.1%) statin users among the 44,290 residents categorized as frail. In an adjusted mixed-effects logistic regression model, frail residents (adjusted odds ratio = 0.62, 95% confidence interval 0.58–0.65) were significantly less likely to be statin users compared with non-frail residents. After adjustment for resident characteristics, the intraclass correlation coefficient indicated that between-physician variability accounted for 9.1% of the residual unexplained variation in statin use (P < .001). Among the 894 physicians assigned 20 or more residents, funnel plots confirmed there were more low-outlying (17.4%) and high-outlying (12.0%) prescribers of statins than expected by chance. Physicians who were high-outlying prescribers had higher historical rates of statin prescribing. Conclusions and Relevance Statin prescribing was substantial within nursing homes, even among frail residents. After controlling for resident characteristics, the likelihood of statin prescribing varied significantly across physicians. Further studies are required to evaluate the risks and benefits of statin use, and discontinuation, among nursing home residents to better inform clinical practice in this setting.

BackgroundPostmarket surveillance of medical devices is reliant on physician reporting of adverse medical device events (AMDEs). Little is known about factors that influence whether and how physicians report AMDEs, an essential step in developing behaviour change interventions. This study explored factors that influence AMDE reporting.MethodsQualitative interviews were conducted with physicians who differed by specialties that implant cardiovascular and orthopaedic devices prone to AMDEs, geography and years in practice. Participants were asked if and how they reported AMDEs, and the influencing factors. Themes were identified inductively using constant comparative technique, and reviewed and discussed by the research team on four occasions.ResultsTwenty-two physicians of varying specialty, region, organisation and career stage perceived AMDE reporting as unnecessary, not possible or futile due to multiple factors. Physicians viewed AMDEs as an expected part of practice that they could manage by switching to different devices or developing work-around strategies for problematic devices. Physician beliefs and behaviour were reinforced by limited healthcare system capacity and industry responsiveness. The healthcare system lacked processes and infrastructure to detect, capture, share and act on information about AMDEs, and constrained device choice through purchasing contracts. The device industry did not respond to reports of AMDEs from physicians or improve their products based on such reports. As a result, participants said they used devices that were less than ideal for a given patient, leading to suboptimal patient outcomes.ConclusionsThere may be little point in solely educating or incentivising individual physicians to report AMDEs unless environmental conditions are conducive to doing so. Future research should explore policies that govern AMDEs and investigate how to design and implement postmarket surveillance systems.

Objective To examine associations between baseline frailty measures, antipsychotic use, and hospitalization over 1 year and whether hospitalization risk associated with antipsychotic use varies by frailty level. Methods In this prospective cohort study of 1,066 residents (mean age: 85 years; 77% women) from the Alberta Continuing Care Epidemiological Studies, trained research nurses conducted comprehensive resident assessments at baseline (2006–2007) for sociodemographic characteristics, health conditions, frailty status, behavioral problems, and all medications consumed during the past 3 days. Two separate measures of frailty were assessed, the Cardiovascular Health Study (CHS) phenotype and an 86-item Frailty Index (FI). Time to first hospitalization during follow-up was determined via linkage with the Alberta Inpatient Discharge Abstract Database. Results Baseline frailty status (both measures), but not antipsychotic use, was significantly associated with hospitalization over 1 year. When stratified by frailty, FI-defined frail residents using antipsychotics showed a significantly increased risk for hospitalization (adjusted HR: 1.54; 95% CI: 1.01–2.36) compared with frail nonusers. CHS-defined frail antipsychotic users versus frail nonusers also showed an elevated risk (adjusted HR: 1.67; 95% CI: 0.96–2.88). Nonfrail residents using antipsychotics were significantly less likely to be hospitalized compared with nonfrail nonusers whether defined by the FI (adjusted HR: 0.62; 95% CI: 0.39–0.99) or CHS criteria (adjusted HR: 0.62; 95% CI: 0.40–0.96). Conclusion Frailty measures may be helpful in identifying those who are particularly vulnerable to adverse effects and those who may experience benefit with treatment.

BACKGROUND: Understanding the extent to which current antibiotic prescribing behaviour is influenced by clinicians’ historical patterns of practice will help target interventions to optimize antibiotic use in long-term care. Our objective was to evaluate whether clinicians’ historical prescribing behaviours influence the start, prolongation and class selection for treatment with antibiotics in residents of long-term care facilities. METHODS: We conducted a retrospective cohort study of all physicians who prescribed to residents in long-term care facilities in Ontario between Jan. 1 and Dec. 31, 2014. We examined variability in antibiotic prescribing among physicians for 3 measures: start of treatment with antibiotics, use of prolonged durations exceeding 7 days and selection of fluoroquinolones. Funnel plots with control limits were used to determine the extent of variation and characterize physicians as extreme low, low, average, high and extreme high prescribers for each tendency. Multivariable logistic regression was used to assess whether a clinician’s prescribing tendency in the previous year predicted current prescribing patterns, after accounting for residents’ demographics, comorbidity, functional status and indwelling devices. RESULTS: Among 1695 long-term care physicians, who prescribed for 93 132 residents, there was wide variability in the start of antibiotic treatment (median 45% of patients, interquartile range [IQR] 32%–55%), use of prolonged treatment durations (median 30% of antibiotic prescriptions, IQR 19%–46%) and selection of fluoroquinolones (median 27% of antibiotic prescriptions, IQR 18%–37%). Prescribing tendencies for antibiotics by physicians in 2014 correlated strongly with tendencies in the previous year. After controlling for individual resident characteristics, prior prescribing tendency was a significant predictor of current practice. INTERPRETATION: Physicians prescribing antibiotics exhibited individual, measurable and historical tendencies toward start of antibiotic treatment, use of prolonged treatment duration and class selection. Prescriber audit and feedback may be a promising tool to optimize antibiotic use in long-term care facilities.

Purpose Reports have questioned the technical proficiency of newly graduating surgeons. However, objective data supporting these concerns are limited. Surgical outcomes among recent graduates are an important indicator of residency programs' ability to graduate surgeons who are ready to meet the needs of their patients. This study aimed to investigate the association between a surgeon's number of years of independent practice and the risk of surgical adverse events. Design Population-based cohort study. Participants All patients 66 years of age or older undergoing isolated cataract operations in Ontario, Canada, between January 1, 1997, and December 31, 2013. Methods Cataract surgical outcomes for all operations performed by surgeons commencing practice in the study period were evaluated using linked health care databases. Main Outcome Measures Four serious complications were evaluated: posterior capsule rupture, dropped lens fragments, retinal detachment, and suspected endophthalmitis. Analyses controlled for patient-, surgeon-, and institution-level covariates. Results The study evaluated 1 431 320 cataract operations. Surgeons in their first year of independent practice were more than 9 times more likely to have high complication rates (≥2%) than surgeons in their tenth year (odds ratio [OR], 9.3; 95% confidence interval [CI], 2.7–31.9). Each additional year of independent practice was associated with a 10% decrease in the risk of patients experiencing an adverse surgical event (OR, 0.90 per year of surgeon independent practice; 95% CI, 0.87–0.94). Conclusions In this population-based study, surgical complications were significantly more likely early in surgeons' careers. Interventions may be needed in postgraduate surgical training and early independent career monitoring and mentoring processes to ensure patient safety while continually renewing the surgical workforce.

Staphylococcus aureus bacteremia (SAB) causes significant morbidity and mortality. We assessed the disease severity and clinical outcomes of SAB in patients with pre-existing immunosuppression, compared with immunocompetent patients. A retrospective cohort investigation studied consecutive patients with SAB hospitalized across six hospitals in Toronto, Canada from 2007 to 2010. Patients were divided into immunosuppressed (IS) and immunocompetent (IC) cohorts; the IS cohort was subdivided into presence of one and two or more immunosuppressive conditions. Clinical parameters were compared between cohorts and between IS subgroups. A competing risk model compared in-hospital mortality and time to discharge. A total of 907 patients were included, 716 (79%) were IC and 191 (21%) were IS. Within the IS cohort, 111 (58%) had one immunosuppressive condition and 80 (42%) had two or more conditions. The overall in-hospital mortality was 29%, with no differences between groups (IS 32%, IC 28%, p = 0.4211). There were no differences in in-hospital mortality (sub-distribution hazard ratio [sHR] 1.17, 95% confidence interval [CI] 0.88–1.56, p = 0.2827) or time to discharge (sHR 0.94, 95% CI 0.78–1.15, p = 0.5570). Independent mortality predictors for both cohorts included hypotension at 72 h (IS: p

Objective Patient engagement (PE) is warranted when treatment risks and outcomes are uncertain, as is the case for higher risk medical devices. Previous research found that patients were not engaged in discussions or decisions about implantable medical devices. This study explored physician views about engaging patients in such discussions. Design Qualitative interviews using a basic descriptive approach. Setting Canada. Participants Practicing cardiovascular and orthopaedic physicians. Main outcome measures Level, processes and determinants of PE in medical device discussions and decisions. Results Views were largely similar among 10 cardiovascular and 12 orthopaedic physicians interviewed. Most said that it was feasible to inform and sometimes involve patients in discussions, but not to partner with them in medical device decision-making. PE was constrained by patient (comfort with PE, technical understanding, physiologic/demographic characteristics, prognosis), physician (device preferences, time), health system (purchasing contracts) and device factors (number of devices on market, comparative advantage). A framework was generated to help physicians engage patients in discussions about medical devices, even when decisions may not be preference sensitive due to multiple constraints on choice. Conclusions This study identified that patients are not engaged in discussions or decisions about implantable medical devices. This may be due to multiple constraints. Further research should establish the legitimacy, prevalence and impact of constraining factors, and examine whether and how different levels and forms of PE are needed and feasible.