Social determinants of access to timely elective surgery in Ontario, Canada: a cross-sectional population level study.

BACKGROUND: Equitable access to surgical care has clinical and policy implications. We assess the association between social disadvantage and wait times for elective surgical procedures in Ontario. METHODS: We conducted a cross-sectional analysis using administrative data sets of adults receiving nonurgent inguinal hernia repair, cholecystectomy, hip arthroplasty, knee arthroplasty, arthroscopy, benign uterine surgery and cataract surgery from April 2013 to December 2019. We assessed the relation between exceeding target wait times and the highest versus lowest quintile of marginalization dimensions by use of generalized estimating equations logistic regression. RESULTS: Of the 1 385 673 procedures included, 174 633 (12.6%) exceeded the target wait time. Adjusted analysis for cataract surgery found significantly increased odds of exceeding wait times for residential instability (adjusted odd ratio [OR] 1.16, 95% confidence interval [CI] 1.11-1.21) and recent immigration (adjusted OR 1.12, 95% CI 1.07-1.18). The highest deprivation quintile was associated with 18% (adjusted OR 1.18, 95% CI 1.12-1.24) and 20% (adjusted OR 1.20, 95% CI 1.12-1.28) increased odds of exceeding wait times for knee and hip arthroplasty, respectively. Residence in areas where higher proportions of residents self-identify as being part of a visible minority group was independently associated with reduced odds of exceeding target wait times for hip arthroplasty (adjusted OR 0.82, 95% CI 0.75-0.91), cholecystectomy (adjusted OR 0.68, 95% CI 0.59-0.79) and hernia repair (adjusted OR 0.65, 95% CI 0.56-0.77) with an opposite effect in benign uterine surgery (adjusted OR 1.28, 95% CI 1.17-1.40). INTERPRETATION: Social disadvantage had a small and inconsistent impact on receiving care within wait time targets. Future research should consider these differences as they relate to resource distribution and the organization of clinical service delivery.

Same-day discharge for laparoscopic Heller myotomy.

BACKGROUND: Laparoscopic Heller myotomy is an effective treatment for achalasia. There are little data on the safety and feasibility of same-day discharge after laparoscopic Heller myotomy. OBJECTIVE: This study aimed to describe the experience with same-day discharge after laparoscopic Heller myotomy at one hospital. METHODS: A retrospective cohort study including all patients who underwent laparoscopic Heller myotomy between 2007 and 2016 at University Health Network (UHN), Toronto, Canada. There was no consent required as the study was retrospective study. This study was approved by the UHN IRB. Planned same-day discharge patients were compared to planned inpatient with respect to post-op complications, length of stay, and number of emergency visits. RESULTS: A total of 209 patients were identified. Same-day discharge was planned in 67 (33.5%) cases compared to 133 (66.5%) cases that were planned for inpatient. The study population was 49% male. On average, inpatients had 2.3 pre-operative comorbidities and same-day discharge patients had 1.6 pre-operative comorbidities. The average length of stay for the inpatient group was 3.5 days. Among the same-day surgery group, 15 had an unplanned admission following surgery (22%). Of those who were admitted, the average length of stay was 1.27 days. Only 1 same-day discharge was readmitted after hospital discharge, while 4 in inpatient group were readmitted. The post-operative complication rate was (15%) 20 of inpatient compared to four (6.0%) of same-day discharge. Number of emergency visits for inpatient group were 7 (5.3%) compared to 3 (4.5%) for same-day discharge group. There was one mortality case in inpatient group due to post-op complication. CONCLUSION: Same-day surgery is feasible for laparoscopic Heller myotomy, with a similar complication and readmission rate as inpatient surgery.

Bias estimation in study design: a meta-epidemiological analysis of transcatheter versus surgical aortic valve replacement.

BACKGROUND: Paucity of RCTs of non-drug technologies lead to widespread dependence on non-randomized studies. Relationship between nonrandomized study design attributes and biased estimates of treatment effects are poorly understood. Our purpose was 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. 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.

Wait-time reporting systems for elective surgery in Canada: a content analysis of provincial and territorial initiatives.

BACKGROUND: In Canada, a substantial barrier to the accessibility of surgical procedures is wait times. The objective of this study was to develop and describe an inventory of wait-time reporting systems for elective surgical procedures. METHODS: Between June and August 2019, we searched all Canadian provincial and territorial ministry of health websites to identify the wait-time reporting systems in place. We conducted content analysis and used a qualitative descriptive approach to compare the variables of interest across the provinces and territories. RESULTS: There were websites available for assessment in all 13 provinces and territories. Seven provinces have comprehensive, centralized wait-time reporting systems. The rest of the provinces have highly decentralized wait-time reporting, and the territories do not have wait-time reporting systems in place. There is substantial variation in the comprehensiveness, purpose, data sources and data collection methods among the wait-time reporting systems across the provinces and territories. INTERPRETATION: Wait-time reporting for elective surgery in Canada is diverse, and it varies in comprehensiveness across the provinces and territories. The present findings can help direct future investigations of Canadian reporting systems, which would provide useful information for policy-makers and those interested in reducing wait times in Canada.

Elective surgery wait time reduction in Canada: A synthesis of provincial initiatives.

In an effort to reduce wait times, Canadian provincial governments have introduced numerous wait time reduction programs and policies. The objective of this study was to provide an overview of elective surgery wait time reduction initiatives across the Canadian provinces from 2000 to 2018. Each of the 10 provincial government web sites were searched. A theoretical framework for elective surgery wait time reduction policies was developed. The final framework is broadly organized into a supply-demand-performance management model. The majority were categorized as supply-oriented initiatives, which have been implemented by all the provinces in some form. Demand-oriented initiatives have been implemented the least. Our conceptual framework may be used to categorize wait time reduction initiatives for the purpose of policy development and evaluation.

MEDICAL DEVICE RECALLS IN CANADA FROM 2005 TO 2015.

OBJECTIVES: Medical devices are ubiquitous in modern medical care. However, little is known about the epidemiology of medical devices in the healthcare marketplace, including the rate at which medical devices are subject to recalls or other advisories. We sought to study the epidemiology of medical devices in Canada, focusing on device recalls. In Canada, a recall may signify a variety of events, ranging from relatively minor field safety notifications, to removal of a product from the marketplace. METHODS: We used data from Health Canada to study medical device recalls in Canada from 2005 to 2015. We analyzed the risks of medical device recalls according to the risk class of the device (I lowest; IV highest) and the hazard priority of the recall (Type I highest potential harm; Type III lowest potential harm). RESULTS: During a 10-year period, there were 7,226 medical device recalls. Most recalls were for intermediate risk class (Class II, 40.1 percent; Class III, 38.7 percent) medical devices. Among recalled devices, 5.0 percent were judged to have a reasonable probability of serious adverse health consequences or death (Type I recall Hazard Priority classification). While the number of medical devices marketed in Canada is not known, over a similar 10-year period, 24,849 new Class II, II, and IV medical device licenses were issued by Health Canada. CONCLUSIONS: Several hundred medical device recalls occur in Canada each year. Further research is needed to characterize the nature of medical device recalls, and to explore how consumers use information about recalls.

Factors constraining patient engagement in implantable medical device discussions and decisions: interviews with physicians.

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.

Meta-Review of the Quantity and Quality of Evidence for Knee Arthroplasty Devices.

INTRODUCTION: Some cardiovascular devices are licensed based on limited evidence, potentially exposing patients to devices that are not safe or effective. Research is needed to ascertain if the same is true of other types of medical devices. Knee arthroplasty is a widely-used surgical procedure yet implant failures are not uncommon. The purpose of this study was to characterize available evidence on the safety and effectiveness of knee implants. METHODS: A review of primary studies included in health technology assessments (HTA) on total (TKA) and unicompartmental knee arthroplasty (UKA) was conducted. MEDLINE, EMBASE, CINAHL, Cochrane Library and Biotechnology & BioEngineering Abstracts were searched from 2005 to 2014, plus journal tables of contents and 32 HTA web sites. Patients were aged 18 and older who underwent primary TKA or UKA assessed in cohort or randomized controlled studies. Summary statistics were used to report study characteristics. RESULTS: A total of 265 eligible primary studies published between 1986 and 2014 involving 59,217 patients were identified in 10 HTAs (2 low, 7 moderate, 1 high risk of bias). Most evaluated TKA (198, 74.5%). The quality of evidence in primary studies was limited. Most studies were industry-funded (23.8%) or offered no declaration of funding or conflict of interest (44.9%); based on uncontrolled single cohorts (58.5%), enrolled fewer than 100 patients (66.4%), and followed patients for 2 years or less (UKA: single cohort 29.8%, comparative cohort 16.7%, randomized trial 25.0%; TKA: single cohort 25.0%, comparative cohort 31.4%, randomized trial 48.6%). Furthermore, most devices were evaluated in only one study (55.3% TKA implants, 61.1% UKA implants). CONCLUSIONS: Patients, physicians, hospitals and payers rely on poor-quality evidence to support decisions about knee implants. Further research is needed to explore how decisions about the use of devices are currently made, and how the evidence base for device safety and effectiveness can be strengthened.

Achalasia-Specific Quality of Life After Pneumatic Dilation or Laparoscopic Heller Myotomy With Partial Fundoplication: A Multicenter, Randomized Clinical Trial.

OBJECTIVES: Achalasia is a chronic, progressive, and incurable esophageal motility disease. There is clinical uncertainty about which treatment should be recommended as first-line therapy. Our objective was to evaluate the effectiveness of pneumatic dilation compared with laparoscopic Heller myotomy with partial fundoplication in improving achalasia-specific quality of life. METHODS: This was a prospective, multicenter, randomized trial at five academic hospitals in Canada. Fifty previously untreated adults with a clinical diagnosis of primary achalasia, confirmed by manometric testing, were enrolled between November 2005 and March 2010, and followed for 5 years after treatment. Randomization was stratified by site, in random blocks of size four and with balanced allocation. Patients were treated with pneumatic dilation or laparoscopic Heller myotomy with partial fundoplication. The primary outcome was the difference between the treatments in the mean improvement of the achalasia severity questionnaire (ASQ) score at 1 year from baseline. Prespecified secondary outcomes included general and gastrointestinal quality of life, symptoms, esophageal physiology measures (lower esophageal sphincter relaxation and pressure, esophageal emptying, abnormal esophageal acid exposure), complications, and incidence of retreatment. Functional and imaging studies were performed blinded and all outcome assessors were blinded. RESULTS: There were no significant differences between treatments in the improvement of ASQ score at 1 year from baseline (27.5 points in the Heller myotomy arm vs. 20.2 points in the pneumatic dilation arm; difference 7.3 points, 95% confidence interval -4.7 to 19.3; P=0.23). There were no differences between treatments in improvement of symptoms, general and gastrointestinal quality of life, or measures of esophageal physiology. Improvements in ASQ score diminished over time for both interventions. At 5 years, there were no differences between treatments in improvement of ASQ score, symptoms, and general or gastrointestinal quality of life. There were no serious adverse events. No patient who received Heller myotomy required retreatment, whereas five patients treated initially with pneumatic dilation required retreatment. CONCLUSIONS: Treatment with pneumatic dilation or laparoscopic Heller myotomy similarly improves achalasia-specific disease severity at 1 year. Either of the therapeutic approaches can be used as first-line therapy for previously untreated adults with achalasia.

Quality of narrative operative reports in pancreatic surgery.

BACKGROUND: Quality in health care can be evaluated using quality indicators (QIs). Elements contained in the surgical operative report are potential sources for QI data, but little is known about the completeness of the narrative operative report (NR). We evaluated the completeness of the NR for patients undergoing a pancreaticoduodenectomy. METHODS: We reviewed NRs for patients undergoing a pancreaticoduodenectomy over a 1-year period. We extracted 79 variables related to patient and narrator characteristics, process of care measures, surgical technique and oncology-related outcomes by document analysis. Data were coded and evaluated for completeness. RESULTS: We analyzed 74 NRs. The median number of variables reported was 43.5 (range 13-54). Variables related to surgical technique were most complete. Process of care and oncology-related variables were often omitted. Completeness of the NR was associated with longer operative duration. CONCLUSION: The NRs were often incomplete and of poor quality. Important elements, including process of care and oncology-related data, were frequently missing. Thus, the NR is an inadequate data source for QI. Development and use of alternative reporting methods, including standardized synoptic operative reports, should be encouraged to improve documentation of care and serve as a measure of quality of surgical care.

CONTEXTE: Il est possible d'évaluer la qualité des soins de santé au moyen d'indicateurs de qualité (IQ). Les éléments contenus dans les notes opératoires (NO) sont une source potentielle de renseignements pouvant servir d'IQ, mais on en sait peu sur leur exhaustivité. Nous avons voulu évaluer l'exhaustivité des NO dans les dossiers de patients soumis à une pancréatoduodénectomie. MÉTHODES: Nous avons passé en revue les NO dans les dossiers de patients soumisà une pancréatoduodénectomie sur une période d'un an. Par analyse des documents, nous avons extrait 79 variables liées aux caractéristiques des patients et aux rédacteurs des NO, aux mesures des protocoles opératoires, à la technique chirurgicale et aux résultats oncologiques. Nous avons encodé et évalué ces données en fonction de leur exhaustivité. RÉSULTATS: Nous avons analysé les NO pour 74 interventions. Le nombre médian de variables relevées était de 43,5 (entre 13 et 54). Les variables liées au protocole de soins et les variables oncologiques étaient souvent omises. L'exhaustivité des NO était proportionnelle à la durée de l'intervention. CONCLUSION: Les NO sont souvent incomplètes et leur qualité laisse à désirer. Des éléments importants, dont le protocole opératoire et les données oncologiques, étaient souvent manquants. Ainsi, les NO constituent une source inadéquate de données en ce qui concerne les IQ. Il faudra encourager la mise au point et l'utilisation d'autres types de rapports, dont des synopsis opératoires standardisés, pour mieux documenter les soins chirurgicaux prodigués et pour en évaluer la qualité.

The cost of achalasia: quantifying the effect of symptomatic disease on patient cost burden, treatment time, and work productivity.

INTRODUCTION: Although the incidence of achalasia is low, the burden of suffering is high because it is a chronic incurable disease that predominantly affects young persons. This article aims to describe the impact of achalasia on health-related quality of life, patient cost burden, time dedicated to treatment, and work productivity. METHODS: Consecutive patients enrolled in a clinical trial comparing laparoscopic myotomy with pneumatic dilatation from 4 sites across Canada (whose clinical and manometric diagnosis was confirmed) were studied using standardized patient-reported outcomes instruments, including the Achalasia Severity Questionnaire (ASQ), the Medical Outcomes Study 36-item Short Form Questionnaire (SF-36), and the Gastrointestinal Disease-Specific Quality of Life (GIQLI) questionnaire. The authors also measured health care utilization. RESULTS: Questionnaires were completed by 54 patients (median age = 53.5 years; range = 25-78 years; 50.0% male). Patients had been experiencing symptoms for a mean of 4.5 years (standard deviation = 6.1), and 42.6% were on medication for symptom relief. Among them, 74.1% reported that their disease limited their lifestyle. Patients spent an average of CAD$30.70 a month on medication; 37.0% reported that their disease interfered with their work, and patients missed an average of 10.2 days per 6 months. Patients also spent an average of CAD$24.30 on transportation to and from each clinical appointment. CONCLUSION: Achalasia substantially limits the lifestyle of patients with the disease. It also implies a financial burden of care for patients and leads to decreased work productivity.