Publications by authors named "Kednapa Thavorn"

197 Publications

Trends in all-cause mortality and inpatient and outpatient visits for ambulatory care sensitive conditions during the first year of the COVID-19 pandemic: A population-based study.

J Hosp Med 2022 Aug 5. Epub 2022 Aug 5.

ICES, Ontario, Canada.

Background: The impact of the COVID-19 pandemic on the management of ambulatory care sensitive conditions (ACSCs) remains unknown.

Objectives: To compare observed and expected (projected based on previous years) trends in all-cause mortality and healthcare use for ACSCs in the first year of the pandemic (March 2020 to March 2021).

Design, Setting And Participants: We conducted a population-based study using provincial health administrative data on general adul population (Ontario, Canada).

Outcomes And Measures: Monthly all-cause mortality, and hospitalizations, emergency department (ED) and outpatient visit rates (per 100,000 people at-risk) for seven combined ACSCs (asthma, chronic obstructive pulmonary disease, angina, congestive heart failure, hypertension, diabetes, and epilepsy) during the first year were compared with similar periods in previous years (2016-2019) by fitting monthly time series autoregressive integrated moving-average models.

Results: Compared to previous years, all-cause mortality rates increased at the beginning of the pandemic (observed rate in March to May 2020 of 79.98 vs. projected of 71.24 [66.35-76.50]) and then returned to expected in June 2020-except among immigrants and people with mental health conditions where they remained elevated. Hospitalization and ED visit rates for ACSCs remained lower than projected throughout the first year: observed hospitalization rate of 37.29 versus projected of 52.07 (47.84-56.68); observed ED visit rate of 92.55 versus projected of 134.72 (124.89-145.33). ACSC outpatient visit rates decreased initially (observed rate of 4299.57 vs. projected of 5060.23 [4712.64-5433.46]) and then returned to expected in June 2020.
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http://dx.doi.org/10.1002/jhm.12920DOI Listing
August 2022

Costs of Next-Generation Sequencing Assays in Non-Small Cell Lung Cancer: A Micro-Costing Study.

Curr Oncol 2022 Jul 23;29(8):5238-5246. Epub 2022 Jul 23.

Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON K1H 8L6, Canada.

Next-generation sequencing (NGS) of tumor genomes has changed and improved cancer treatment over the past few decades. It can inform clinicians on the optimal therapeutic approach in many of the solid and hematologic cancers, including non-small lung cancer (NSCLC). Our study aimed to determine the costs of NGS assays for NSCLC diagnostics. We performed a micro-costing study of four NGS assays (Trusight Tumor 170 Kit (Illumina), Oncomine Focus (Thermo Fisher), QIAseq Targeted DNA Custom Panel and QIASeq Targeted RNAscan Custom Panel (Qiagen), and KAPA HyperPlus/SeqCap EZ (Roche)) at the StemCore Laboratories, the Ottawa Hospital, Canada. We used a time-and-motion approach to measure personnel time and a pre-defined questionnaire to collect resource utilization. The unit costs were based on market prices. The cost data were reported in 2019 Canadian dollars. Based on a case throughput of 500 cases per year, the per-sample cost for TruSight Tumor 170 Kit, QIASeq Targeted DNA Custom Panel and QIASeq Targeted RNAscan Custom Panel, Oncomine Focus, and HyperPlus/SeqCap EZ were CAD 1778, CAD 599, CAD 1100 and CAD 1270, respectively. The key cost drivers were library preparation (34-60%) and sequencing (31-51%), followed by data analysis (6-13%) and administrative support (2-7%). Trusight Tumor 170 Kit was the most expensive NGS assay for NSCLC diagnostics; however, an economic evaluation is required to identify the most cost-effective NGS assay. Our study results could help inform decisions to select a robust platform for NSCLC diagnostics from fine needle aspirates, and future economic evaluations of the NGS platforms to guide treatment selections for NSCLC patients.
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http://dx.doi.org/10.3390/curroncol29080416DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9330154PMC
July 2022

Economic feasibility of a novel tool to assist extubation decision-making: an early health economic modeling.

Int J Technol Assess Health Care 2022 Jul 11;38(1):e66. Epub 2022 Jul 11.

Clinical Epidemiology Program, Ottawa Hospital Research Institute, The Ottawa Hospital, Ottawa, ON, Canada.

Objectives: To estimate the minimum percent change in failed extubation to make a tool designed to reduce extubation failure (Extubation Advisor [EA]) economically viable.

Methods: We conducted an early return on investment (ROI) analysis using data from intubated intensive care unit (ICU) patients at a large Canadian tertiary care hospital. We obtained input parameters from the hospital database and published literature. We ran generalized linear models to estimate the attributable length of stay, total hospital cost, and time to subsequent extubation attempt following failure. We developed a Markov model to estimate the expected ROI and performed probabilistic sensitivity analyses to assess the robustness of findings. Costs were presented in 2020 Canadian dollars (C$).

Results: The model estimated a 1 percent reduction in failed extubation could save the hospital C$289 per intubated patient (95 percent CI: 197, 459). A large center seeing 2,500 intubated ICU patients per year could save C$723,124/year/percent reduction in failed extubation. At the current annual price of C$164,221, the EA tool must reduce extubation failure by at least 0.24 percent (95 percent CI: .14, .41) to make the tool cost-effective at our site.

Conclusions: Clinical decision-support tools like the EA may play an important role in reducing healthcare costs by reducing the rate of extubation failure, a costly event in the ICU.
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http://dx.doi.org/10.1017/S0266462322000472DOI Listing
July 2022

Length of initial prescription at hospital discharge and long-term medication adherence for elderly, post-myocardial infarction patients: a population-based interrupted time series study.

BMC Med 2022 06 21;20(1):213. Epub 2022 Jun 21.

Clinical Epidemiology Program, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, ON, Canada.

Background: Preliminary evidence suggests that providing longer duration prescriptions at discharge may improve long-term adherence to secondary preventative cardiac medications among post-myocardial infarction (MI) patients. We implemented and assessed the effects of two hospital-based interventions-(1) standardized prolonged discharge prescription forms (90-day supply with 3 repeats for recommended cardiac medications) plus education and (2) education only-on long-term cardiac medication adherence among elderly patients post-MI.

Methods: We conducted an interrupted time series study of all post-MI patients aged 65-104 years in Ontario, Canada, discharged from hospital between September 2015 and August 2018 with ≥ 1 dispensation(s) for a statin, beta blocker, angiotensin system inhibitor, and/or secondary antiplatelet within 7 days post-discharge. The standardized prolonged discharge prescription forms plus education and education-only interventions were implemented at 2 (1,414 patients) and 4 (926 patients) non-randomly selected hospitals in September 2017 for 12 months, with all other Ontario hospitals (n = 143; 18,556 patients) comprising an external control group. The primary outcome, long-term cardiac medication adherence, was defined at the patient-level as an average proportion of days covered (over 1-year post-discharge) ≥ 80% across cardiac medication classes dispensed at their index fill. Primary outcome data were aggregated within hospital groups (intervention 1, 2, or control) to monthly proportions and independently analyzed using segmented regression to evaluate intervention effects. A process evaluation was conducted to assess intervention fidelity.

Results: At 12 months post-implementation, there was no statistically significant effect on long-term cardiac medication adherence for either intervention-standardized prolonged discharge prescription forms plus education (5.4%; 95% CI - 6.4%, 17.2%) or education only (1.0%; 95% CI - 28.6%, 30.6%)-over and above the counterfactual trend; similarly, no change was observed in the control group (- 0.3%; 95% CI - 3.6%, 3.1%). During the intervention period, only 10.8% of patients in the intervention groups received ≥ 90 days, on average, for cardiac medications at their index fill.

Conclusions: Recognizing intervention fidelity was low at the pharmacy level, and no statistically significant post-implementation differences in adherence were found, the trends in this study-coupled with other published retrospective analyses of administrative data-support further evaluation of this simple intervention to improve long-term adherence to cardiac medications.

Trial Registration: ClinicalTrials.gov : NCT03257579 , registered June 16, 2017 Protocol available at: https://pubmed.ncbi.nlm.nih.gov/33146624/ .
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http://dx.doi.org/10.1186/s12916-022-02401-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9210591PMC
June 2022

Protocol for a scoping review of sepsis epidemiology.

Syst Rev 2022 Jun 19;11(1):125. Epub 2022 Jun 19.

Li Ka Shing Knowledge Institute, St. Michael's Hospital, Unity Health Toronto, Toronto, ON, Canada.

Introduction: Sepsis is a common, life-threatening syndrome of physiologic, pathologic, and biochemical abnormalities that are caused by infection and propagated by a dysregulated immune response. In 2017, the estimated annual incidence of sepsis around the world was 508 cases per 100,000 (95% confidence interval [CI], 422-612 cases per 100,000), however, reported incidence rates vary significantly by country. A scoping review will identify knowledge gaps by systematically investigating the incidence of sepsis.

Methods And Analysis: This scoping review will be guided by the updated JBI (formerly Joanna Briggs Institute) methodology. We will search the following electronic databases: MEDLINE, EMBASE, CINAHL, and Cochrane Database of Systematic Reviews/Central Register of Controlled Trials. In addition, we will search websites of trial and study registries. We will review titles and abstracts of potentially eligible studies and then full-texts by two independent reviewers. We will include any study that is focused on the incidence of sepsis or septic shock in any population. Data will be abstracted independently using pre-piloted data extraction forms, and we will present results according to the Preferred Reporting Items for Systematic Reviews and Meta-analysis Protocols Extension for Scoping Reviews.

Ethics And Dissemination: The results of this review will be used to create a publicly available indexed and searchable electronic registry of existing sepsis research relating to incidence in neonates, children, and adults. With input from stakeholders, we will identify the implications of study findings for policy, practice, and research. Ethics approval was not required given this study reports on existing literature.
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http://dx.doi.org/10.1186/s13643-022-02002-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9208121PMC
June 2022

Disparities and Factors Associated with Coronavirus Disease-2019-Related Public Stigma: A Cross-Sectional Study in Thailand.

Int J Environ Res Public Health 2022 05 25;19(11). Epub 2022 May 25.

Department of Pharmaceutical Care, Faculty of Pharmacy, Chiang Mai University, Chiang Mai 50200, Thailand.

Coronavirus disease 2019 (COVID-19)-related public stigma is a major challenge, with scarce available evidence. This study aimed to determine the disparities and factors associated with COVID-19-related public stigma in the Thai population. We conducted a cross-sectional study involving a voluntary online survey in Thailand from 21 April 2020 to 4 May 2020. We invited 4004 participants to complete a series of questionnaires, including the validated COVID-19 public stigma scale and questions on relevant COVID-19-related psychosocial issues. Multinomial logistic regression was performed to investigate the factors associated with COVID-19-related public stigma. The prevalence of COVID-19-related public stigma was 24.2% (95% confidence interval [CI], 22.2-26.2) for no/minimal, 35.5% (95% CI, 33.4-37.6) for moderate, and 40.3% (95% CI, 38.2-42.4) for high. We observed disparities in the prevalence of COVID-19-related public stigma according to participant characteristics and psychosocial factors. Using the no/minimal group as a reference group, the six predominant risk factors significantly associated with a moderate and high degree of COVID-19-related public stigma were middle-aged or older adults, male, divorced/widowed/separated, current quarantine status, moderate/severe fear of COVID-19, and medium/high perceived risk of COVID-19. Additional risk factors significantly related to a high degree of COVID-19-related public stigma were religion (Buddhist), region of residence (non-capital city), and exposure to COVID-19-related information. Disparities in COVID-19-related public stigma due to sociodemographic and psychosocial issues are frequent in the Thai population. To reduce public stigmatization, early identification of vulnerable groups and the development of tailored mitigation strategies should be implemented during the pandemic.
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http://dx.doi.org/10.3390/ijerph19116436DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9180735PMC
May 2022

Outpatient parenteral antibiotic therapy (OPAT) and inpatient treatment strategies for emergency department patients with cellulitis: a cost analysis.

CJEM 2022 Aug 8;24(5):520-528. Epub 2022 Jun 8.

Clinical Epidemiology Program, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, ON, Canada.

Objectives: Emergency department (ED) patients with cellulitis requiring intravenous antibiotics may be treated via outpatient parenteral antibiotic therapy (OPAT) as opposed to hospitalization. The primary objective was to compare healthcare costs for the following strategies: community intravenous antibiotics with referral to an OPAT clinic operated by infectious disease specialists ('OPAT clinic' strategy); community intravenous antibiotics with return to ED if necessary ('return to ED' strategy); and hospital admission.

Methods: Using a hospital administrative database, we conducted a cost analysis using patient-level data of adult cellulitis patients presenting to two tertiary care EDs and were treated with intravenous antibiotics in one of three ways: OPAT clinic strategy; return to ED strategy; and hospital admission. Costs were estimated from Canada's publicly funded health system perspective. The primary outcome was the mean total cost (2015 CAD) per patient for each treatment strategy. A generalized linear model was performed to adjust for baseline characteristics, including age, sex and comorbidities.

Results: A total of 808 patients met inclusion criteria: OPAT clinic strategy (N = 341); return to ED strategy (N = 228) and hospital admission (N = 239). The mean total cost of care for the treatment strategies were: OPAT clinic: $2170 (95% CI $1905-$2436); return to ED: $1493 (95 %CI $1264-$1722); and hospital admission: $10,145 (95% CI $8668-$11,622). Results from the regression analysis suggested that the OPAT clinic strategy was associated with a cost-saving of $7394 (95% CI $6154-$8633, p < 0.001) compared to hospital admission and an increased cost of $651 (95% CI $367-$935, p < 0.001) when compared to the return to ED approach.

Conclusions: This is the first Canadian study that compares the cost of different OPAT strategies for cellulitis patients. While both OPAT strategies are safe and far less costly than hospital admission, our findings suggest that a dedicated OPAT clinic for patients with cellulitis is more expensive than the return to ED strategy.
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http://dx.doi.org/10.1007/s43678-022-00320-1DOI Listing
August 2022

Benefits and Harms of Treatment and Preventive Interventions for Hereditary Angioedema: Protocol for a Systematic Review and Network Meta-Analysis of Randomized Controlled Trials.

Genes (Basel) 2022 05 22;13(5). Epub 2022 May 22.

Pharmacoepidemiology and Statistics Research Center (PESRC), Chiang Mai University, Chiang Mai 50200, Thailand.

Background: Hereditary angioedema (HAE) is a rare genetic disease that can lead to potentially life-threatening airway attacks. Although novel therapies for HAE treatment have become available over the past decades, a comparison of all available treatments has not yet been conducted. As such, we will perform a systematic review and network meta-analysis to identify the best evidence-based treatments for the management of acute attacks and prophylaxis of HAE.

Methods: This study will include both parallel and crossover randomized controlled trials that have investigated prevention or treatment strategies for HAE attacks. We will search electronic databases, including Medline, Embase, PubMed, Cochrane Library, Scopus, and CINAHL, from inception with no language restrictions. Potential trials will be supplemented through a gray literature search. The process of study screening, selection, data extraction, risk-of-bias assessment, certainty assessment and classification of treatments will be performed independently by a pair of reviewers. Any discrepancy will be addressed through team discussion. A two-step approach of pairwise and network meta-analysis will be performed. The summarized effect estimates of direct and indirect treatment comparisons will be pooled using DerSimonion-Laird random-effects models. The incoherence assumption, in terms of the consistency of direct and indirect effects, will be assessed. An evidence-based synthesis will be performed, based on the magnitudes of effect size, evidence certainty, and ranking of treatment effects, with respect to treatment benefits and harms.

Discussion: This systematic review and network meta-analysis will summarize evidence-based conclusions with respect to the ratio of benefits and harms arising from interventions for the treatment of acute attacks and prophylaxis of HAE. Evidence from this network estimate could promote the rational use of interventions among people living with HAE in clinical practice settings. PROSPERO registration number: CRD42021251367.
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http://dx.doi.org/10.3390/genes13050924DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9141233PMC
May 2022

Use of Thiazide Diuretics and Risk of All Types of Skin Cancers: An Updated Systematic Review and Meta-Analysis.

Cancers (Basel) 2022 May 23;14(10). Epub 2022 May 23.

Department of Medicine, Division of Nephrology, University of Ottawa, Ottawa, ON K1H 8L6, Canada.

Background: The use of thiazide diuretics is associated with skin cancer risk; however, whether this applies to all skin cancer types is unclear.

Methods: In this meta-analysis, we searched multiple electronic databases and gray literature up to 10 April 2022, with no language restrictions, to identify relevant randomized controlled trials (RCTs) and non-randomized studies (cohort, case-control) that investigated the association between thiazide diuretics and skin cancer. The primary outcomes of interest were malignant melanoma and non-melanoma skin cancer (basal cell carcinoma [BCC], squamous cell carcinoma [SCC]). Secondary outcomes included other skin cancers (lip cancer, Merkel cell carcinoma, malignant adnexal skin tumors, oral cavity cancer, and precursors of skin cancer). We used a random-effects meta-analysis to estimate pooled adjusted odds ratios (ORs) and 95% confidence intervals (CIs).

Results: Thirty non-randomized studies (17 case-control, 13 cohort, no RCTs) were included. Thiazide diuretic users had a higher risk of malignant melanoma (17 studies; = 10,129,196; pooled adjusted OR, 1.10; 95% CI, 1.04-1.15; < 0.001; strength of evidence, very low; very small harmful effect), BCC (14 studies; = 19,780,476; pooled adjusted OR, 1.05; 95% CI, 1.02-1.09; = 0.003; strength of evidence, very low; very small harmful effect), and SCC (16 studies; = 16,387,862; pooled adjusted OR, 1.35; 95% CI, 1.22-1.48; < 0.001; strength of evidence, very low; very small harmful effect) than non-users. Thiazide diuretic use was also associated with a higher risk of lip cancer (5 studies; = 161,491; pooled adjusted OR, 1.92; 95% CI, 1.52-2.42; < 0.001; strength of evidence, very low; small harmful effect), whereas other secondary outcomes were inconclusive.

Conclusions: Thiazide diuretics are associated with the risk of all skin cancer types, including malignant melanoma; thus, they should be used with caution in clinical practice.
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http://dx.doi.org/10.3390/cancers14102566DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9140049PMC
May 2022

Recommendations for the Design and Delivery of Transitions-Focused Digital Health Interventions: Rapid Review.

JMIR Aging 2022 May 19;5(2):e35929. Epub 2022 May 19.

March of Dimes Canada, Toronto, ON, Canada.

Background: Older adults experience a high risk of adverse events during hospital-to-home transitions. Implementation barriers have prevented widespread clinical uptake of the various digital health technologies that aim to support hospital-to-home transitions.

Objective: To guide the development of a digital health intervention to support transitions from hospital to home (the Digital Bridge intervention), the specific objectives of this review were to describe the various roles and functions of health care providers supporting hospital-to-home transitions for older adults, allowing future technologies to be more targeted to support their work; describe the types of digital health interventions used to facilitate the transition from hospital to home for older adults and elucidate how these interventions support the roles and functions of providers; describe the lessons learned from the design and implementation of these interventions; and identify opportunities to improve the fit between technology and provider functions within the Digital Bridge intervention and other transition-focused digital health interventions.

Methods: This 2-phase rapid review involved a selective review of providers' roles and their functions during hospital-to-home transitions (phase 1) and a structured literature review on digital health interventions used to support older adults' hospital-to-home transitions (phase 2). During the analysis, the technology functions identified in phase 2 were linked to the provider roles and functions identified in phase 1.

Results: In phase 1, various provider roles were identified that facilitated hospital-to-home transitions, including navigation-specific roles and the roles of nurses and physicians. The key transition functions performed by providers were related to the 3 categories of continuity of care (ie, informational, management, and relational continuity). Phase 2, included articles (n=142) that reported digital health interventions targeting various medical conditions or groups. Most digital health interventions supported management continuity (eg, follow-up, assessment, and monitoring of patients' status after hospital discharge), whereas informational and relational continuity were the least supported. The lessons learned from the interventions were categorized into technology- and research-related challenges and opportunities and informed several recommendations to guide the design of transition-focused digital health interventions.

Conclusions: This review highlights the need for Digital Bridge and other digital health interventions to align the design and delivery of digital health interventions with provider functions, design and test interventions with older adults, and examine multilevel outcomes.

International Registered Report Identifier (irrid): RR2-10.1136/bmjopen-2020-045596.
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http://dx.doi.org/10.2196/35929DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9164100PMC
May 2022

Leveraging financial incentives and behavioural economics to engage physicians in achieving quality-improvement process measures.

Can J Surg 2022 Mar-Apr;65(2):E290-E295. Epub 2022 Apr 27.

From the Division of General Surgery, Department of Surgery, University of Ottawa, The Ottawa Hospital, Ottawa, Ont. (Moloo, Lamb, Walsh, Musselman); the The Ottawa Hospital Research Institute, Ottawa, Ont. (Moloo, Thavorn, Musselman, Forster); the School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, Ottawa, Ont. (Lamb, Thavorn); the Division of Thoracic Surgery, Department of Surgery, University of Ottawa, The Ottawa Hospital, Ottawa, Ont. (Sundaresan); and the Department of Medicine, University of Ottawa, The Ottawa Hospital, Ottawa, Ont. (Forster).

Background: Dedicated quality-improvement (QI) initiatives within health care systems are of clear benefit, and physicians respond to financial incentivization. The Canadian health care system often lacks this lever, and many financially incentivized QI programs rely on traditional economic principles. We describe our evaluation of financial incentivization for the implementation of QI process metrics in a department of surgery at a Canadian academic hospital system and its impact over a 4-year period.

Methods: Quality-improvement processes informed by extant QI incentivization literature and guided by the principles of behavioural economics were implemented within our institution's Department of Surgery. Disbursement of supplemental government funding was modified to be contingent on the ability of divisions within the department to meet predefined QI metrics, including regular multidisciplinary meetings, morbidity and mortality rounds with documented feedback of systemic issues to division members, reviews of adverse events, and implementation of annual patient experience projects. We evaluated the effect of the QI processes from 2015/16 to 2018/19.

Results: There was a significant increase in the number of divisions that satisfied all the QI metrics over the study period, from 2 (28%) in 2015/16, to 5 (71%) in 2016/17, to 7 (100.0%) in 2017/18 and 2018/19 ( < 0.01). The application of behavioural economics principles, such as reward versus penalty payoff, loss aversion, payment separation, aligning of values, and relative social ranking, was important to the outcome of the study.

Conclusion: Incentivizing QI activities in the Canadian health care system is possible and led to improvement in QI processes as a whole in our department. This paper lays out a method of financial reimbursement to facilitate engagement of physicians and establishment of a foundation of important QI processes and measures within a department.
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http://dx.doi.org/10.1503/cjs.017320DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9188803PMC
April 2022

Inclusion of Older Adults in Digital Health Technologies to Support Hospital-to-Home Transitions: Secondary Analysis of a Rapid Review and Equity-Informed Recommendations.

JMIR Aging 2022 Apr 27;5(2):e35925. Epub 2022 Apr 27.

March of Dimes Canada, Toronto, ON, Canada.

Background: Digital health technologies have been proposed to support hospital-to-home transition for older adults. The COVID-19 pandemic and the associated physical distancing guidelines have propelled a shift toward digital health technologies. However, the characteristics of older adults who participated in digital health research interventions to support hospital-to-home transitions remain unclear. This information is needed to assess whether current digital health interventions are generalizable to the needs of the broader older adult population.

Objective: This rapid review of the existing literature aimed to identify the characteristics of the populations targeted by studies testing the implementation of digital health interventions designed to support hospital-to-home transitions, identify the characteristics of the samples included in studies testing digital health interventions used to support hospital-to-home transitions, and create recommendations for enhancing the diversity of samples within future hospital-to-home digital health interventions.

Methods: A rapid review methodology based on scoping review guidelines by Arksey and O'Malley was developed. A search for peer-reviewed literature published between 2010 and 2021 on digital health solutions that support hospital-to-home transitions for older adults was conducted using MEDLINE, Embase, and CINAHL databases. The data were analyzed using descriptive statistics and qualitative content analysis. The Sex- and Gender-Based Analysis Plus lens theoretically guided the study design, analysis, and interpretation.

Results: A total of 34 studies met the inclusion criteria. Our findings indicate that many groups of older adults were excluded from these interventions and remain understudied. Specifically, the oldest old and those living with cognitive impairments were excluded from the studies included in this review. In addition, very few studies have described the characteristics related to gender diversity, education, race, ethnicity, and culture. None of the studies commented on the sexual orientation of the participants.

Conclusions: This is the first review, to our knowledge, that has mapped the literature focusing on the inclusion of older adults in digital hospital-to-home interventions. The findings suggest that the literature on digital health interventions tends to operationalize older adults as a homogenous group, ignoring the heterogeneity in older age definitions. Inconsistency in the literature surrounding the characteristics of the included participants suggests a need for further study to better understand how digital technologies to support hospital-to-home transitions can be inclusive.
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http://dx.doi.org/10.2196/35925DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9096639PMC
April 2022

An Electronic Patient-Reported Outcomes Tool for Older Adults With Complex Chronic Conditions: Cost-Utility Analysis.

JMIR Aging 2022 Apr 20;5(2):e35075. Epub 2022 Apr 20.

Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.

Background: eHealth technologies for self-management can improve quality of life, but little is known about whether the benefits gained outweigh their costs. The electronic patient-reported outcome (ePRO) mobile app and portal system supports patients with multiple chronic conditions to collaborate with primary health care providers to set and monitor health-related goals.

Objective: This study aims to estimate the cost of ePRO and the cost utility of the ePRO intervention compared with usual care provided to patients with multiple chronic conditions and complex needs living in the community, from the perspective of the publicly funded health care payer in Ontario, Canada.

Methods: We developed a decision tree model to estimate the incremental cost per quality-adjusted life year (QALY) gained for the ePRO tool versus usual care over a time horizon of 15 months. Resource utilization and effectiveness of the ePRO tool were drawn from a randomized clinical trial with 6 family health teams involving 45 participants. Unit costs associated with health care utilization (adjusted to 2020 Canadian dollars) were drawn from literature and publicly available sources. A series of sensitivity analyses were conducted to assess the robustness of the findings.

Results: The total cost of the ePRO tool was CAD $79,467 (~US $ 63,581; CAD $1733 [~US $1386] per person). Compared with standard care, the ePRO intervention was associated with higher costs (CAD $1710 [~US $1368]) and fewer QALYs (-0.03). The findings were consistent with the clinical evidence, suggesting no statistical difference in health-related quality of life between ePRO and usual care groups. However, the tool would be considered a cost-effective option if it could improve by at least 0.03 QALYs. The probability that the ePRO is cost-effective was 17.3% at a willingness-to-pay (WTP) threshold of CAD $50,000 (~US $40,000)/QALY.

Conclusions: The ePRO tool is not a cost-effective technology at the commonly used WTP value of CAD $50,000 (~US $40,000)/QALY, but long-term and the societal impacts of ePRO were not included in this analysis. Further research is needed to better understand its impact on long-term outcomes and in real-world settings. The present findings add to the growing evidence about eHealth interventions' capacity to respond to complex aging populations within finite-resourced health systems.

Trial Registration: ClinicalTrials.gov NCT02917954; https://clinicaltrials.gov/ct2/show/NCT02917954.
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http://dx.doi.org/10.2196/35075DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9069297PMC
April 2022

Network meta-analysis of therapies for cluster headache: Effects of acute therapies for episodic and chronic cluster.

Headache 2022 04 28;62(4):482-511. Epub 2022 Mar 28.

University of Ottawa, Ottawa, Ontario, Canada.

Objective: We used network meta-analysis (NMA) to characterize the relative effectiveness and harms of acute treatment options for cluster headache.

Background: There are few evidence-based acute treatments available for cluster headache. As most treatments were compared only against placebos in clinical trials, few head-to-head comparisons of treatments are available.

Methods: An a priori registered scoping review was performed to identify randomized controlled trials evaluating treatments in adult patients (>18 years old) with cluster headache per accepted diagnostic criteria. Bayesian NMAs were performed to compare treatments in terms of headache relief at 15 or 30 min, and also the occurrence of adverse events. We report odds ratios (ORs) of relative treatment effects along with corresponding 95% credible intervals (CrIs), as well as measures of treatment ranking.

Results: A total of 13 randomized controlled trials informed NMAs. We found high flow oxygen to be the most effective therapy for headache response at 15 and 30 min (OR 9.0, 95% CrI 5.3 to 15.9 vs. placebo), with injectable sumatriptan demonstrating the next highest effect (OR 6.4, 95% CrI 3.75 to 11.1 vs. placebo). High flow oxygen was also more effective than low flow oxygen (OR 2.55, 95% CrI 1.13 to 5.8), nasal spray zolmitriptan (OR 3.75, 95% CrI 1.72 to 8.4), octreotide (OR 4.5, 95% CrI 1.64 to 12.5), and non-invasive vagal nerve stimulation (nVNS; OR 5.2, 95% CrI 2.29 to 11.9). Sumatriptan injectable was also effective for headache relief and was found to be better than nasal spray zolmitriptan (OR 2.67, 95% CrI 1.21 to 5.9), octreotide (OR 3.20, 95% CrI 1.17 to 8.8), and nVNS (OR 3.69, 95% CrI 1.63 to 8.4). Octreotide (OR 4.1, 95% CrI 1.71 to 10.5) and sumatriptan (OR 2.40, 95% CrI 1.39 to 4.2) were associated with greater risk of adverse events compared to placebo, while other treatments did not demonstrate increased risk. When focusing on patients with episodic cluster headache, nVNS was significantly better than placebo (OR 4.9, 95% CrI 1.89 to 14.1).

Conclusions: Our findings suggest that high flow oxygen is more efficacious when compared to low flow oxygen for headache relief. When low flow oxygen fails in patients who can tolerate oxygen, increased flow rates should be tried. Additionally, high flow oxygen is likely more effective than zolmitriptan nasal spray, nVNS, and octreotide. Sumatriptan injectable is more likely to be effective when compared to zolmitriptan nasal spray, octreotide, and nVNS.
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http://dx.doi.org/10.1111/head.14283DOI Listing
April 2022

Effects of acute and preventive therapies for episodic and chronic cluster headache: A scoping review of the literature.

Headache 2022 Mar;62(3):329-362

University of Ottawa, Ottawa, Ontario, Canada.

Background: Cluster headache is the most common primary headache disorder of the trigeminal autonomic cephalalgias, and it is highly disabling.

Objective: We undertake a scoping review to characterize therapies to prevent and acutely treat cluster headache, characterize trial methodology utilized in studies, and recommend future trial "good practices." We also assess homogeneity of studies and feasibility for future network meta-analyses (NMAs) to compare acute and preventive treatments for cluster headache.

Methods: A priori protocol for this scoping review was registered and available on Open Science Forum. We sought studies that enrolled adult patients with cluster headache as identified by accepted diagnostic criteria. Both randomized controlled trials (RCTs) and observational studies (with a control group) were included. The interventions of interest were medications, procedures, devices, surgeries, and behavioral/psychological interventions, whereas comparators of interest were placebo, sham, or other active treatments. Outcomes were predefined; however, we did not exclude studies lacking these outcomes. A systemic search was conducted in Ovid Medline, Embase, and Cochrane. We performed a targeted search for conference abstracts from journals prominent in the field.

Results: We identified 56 studies: 45 RCTs, four studies only available in clinical trial registries, and seven observational studies. Of the 45 RCTs, 20 focused on acute therapies and 25 on preventive therapies. Overall, we determined that it is feasible to pursue a NMA for acute therapy focusing on 15 or 30-min headache reduction for acute trials, as we identified 11 trials in the combined population of patients with either episodic or chronic cluster headache (2 trials in populations with chronic cluster headache were also found). For preventive therapy of cluster headache, we identified trials with common outcomes that may be considered for NMA, however, as these trials had differences in treatment effect modifiers that could not be corrected, NMAs appear infeasible for this indication. We identified new studies looking at noninvasive vagal nerve stimulation, sphenopalatine ganglion stimulation, prednisone, and oxygen published since the most recent systematic review in the field, although these acute treatments were previously identified as effective. However, for calcitonin gene-related peptide (CGRP) monoclonal antibodies, galcanezumab demonstrated effectiveness in episodic cluster headache, but a lack of effectiveness in chronic cluster headache, and fremanezumab was not effective for episodic nor chronic cluster headache. This finding highlights that CGRP monoclonal antibodies may not show a class effect in cluster headache prevention and need to be considered individually.

Conclusions: We describe the treatment landscape of cluster headache for both acute and preventive treatments. Last, we present the NMAs we will undertake in acute therapies of cluster headache.
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http://dx.doi.org/10.1111/head.14284DOI Listing
March 2022

Correction to: Economic evaluation of advanced practice physiotherapy models of care: a systematic review with meta-analyses.

BMC Health Serv Res 2022 Mar 10;22(1):324. Epub 2022 Mar 10.

School of Rehabilitation, Faculty of Medicine, Université de Montréal, Montreal, Quebec, Canada.

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http://dx.doi.org/10.1186/s12913-021-07406-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8915506PMC
March 2022

Optimal Timing of Allogeneic Stem Cell Transplantation for Primary Myelofibrosis.

Transplant Cell Ther 2022 04 22;28(4):189-194. Epub 2022 Jan 22.

Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada; Ottawa Hospital Research Institute, Ottawa, Ontario, Canada; Department of Medicine, The Ottawa Hospital, Ottawa, Ontario, Canada. Electronic address:

Primary myelofibrosis (PMF) is a chronic myeloproliferative neoplasm characterized by cytopenias, splenomegaly, and risk of leukemic transformation. In light of newer therapies, such as ruxolitinib, that are not curative but improve quality of life, the timing of transplantation needs more in-depth analysis to determine which patients would benefit from an early versus a delayed transplantation strategy. Because prospective clinical trials are impractical for diseases with only one curative option, such as PMF, we developed a Markov cohort model to simulate the long-term disease trajectory in patients with PMF and predict the optimal timing of transplantation stratified by Dynamic International Prognostic Scoring System (DIPSS) risk. In this decision model, a hypothetical cohort of patients begins in the alive with PMF state and can transition monthly to other health states. Transition probabilities were acquired from published literature. We performed probabilistic analyses by jointly varying all model parameters over 1000 simulations. Irrespective of DIPSS risk, all patients with PMF benefited from transplantation with respect to life expectancy gained. Life expectancy gains from transplantation peaked at 9.7 months (95% confidence interval [CI], 9.5 to 9.9 months) from diagnosis in patients with high-risk disease and at 16.6 months (95% CI, 16.4 to 16.8 months) from diagnosis in patients with intermediate-2 disease. Patients with intermediate-1 risk had a delayed peak in net gain in life expectancy at 20.5 months (95% CI, 20.2 to 20.7 months). Patients with low-risk disease had a greater net gain in life expectancy the longer that transplantation was delayed; this trend plateaued at 29 to 45 months. Our modeling suggests that preparation for transplantation is indicated upfront for patients diagnosed with intermediate-2 risk and high-risk PMF, whereas this can be delayed for low-risk or intermediate-1 risk disease.
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http://dx.doi.org/10.1016/j.jtct.2022.01.018DOI Listing
April 2022

Cost-utility analysis of apixaban compared with usual care for primary thromboprophylaxis in ambulatory patients with cancer.

CMAJ 2021 10;193(40):E1551-E1560

Department of Medicine and the Ottawa Hospital Research Institute (Kimpton, Kumar, Wells, Carrier, Thavorn), and School of Epidemiology and Public Health (Coyle, Thavorn), University of Ottawa, Ottawa, Ont.

Background: Apixaban (2.5 mg) taken twice daily has been shown to substantially reduce the risk of venous thromboembolism (VTE) compared with placebo for the primary thromboprophylaxis of ambulatory patients with cancer who are starting chemotherapy and are at intermediate-to-high risk of VTE. We aimed to compare the health system costs and health benefits associated with primary thromboprophylaxis using apixaban with those associated with the current standard of care (where no primary thromboprophylaxis is given), from the perspective of Canada's publicly funded health care system in this subpopulation of patients with cancer over a lifetime horizon.

Methods: We performed a cost-utility analysis to estimate the incremental cost per quality-adjusted life-year (QALY) gained with primary thromboprophylaxis using apixaban. We obtained baseline event rates and the efficacy of apixaban from the Apixaban for the Prevention of Venous Thromboembolism in High-Risk Ambulatory Cancer Patients (AVERT) trial on apixaban prophylaxis. We estimated relative risk for bleeding, risk of complications associated with VTE treatment, mortality rates, costs and utilities from other published sources.

Results: Over a lifetime horizon, apixaban resulted in lower costs to the health system (Can$7902.98 v. Can$14 875.82) and an improvement in QALYs (9.089 v. 9.006). The key driver of cost-effectiveness results was the relative risk of VTE as a result of apixaban. Results from the probabilistic analysis showed that at a willingness to pay of Can$50 000 per QALY, the strategy with the highest probability of being most cost-effective was apixaban, with a probability of 99.87%.

Interpretation: We found that apixaban is a cost-saving option for the primary thromboprophylaxis of ambulatory patients with cancer who are starting chemotherapy and are at intermediate-to-high risk of VTE.
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http://dx.doi.org/10.1503/cmaj.210523DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8568073PMC
October 2021

Impact of the COVID-19 pandemic on transplantation by income level and cumulative COVID-19 incidence: a multinational survey study.

BMJ Open 2022 01 12;12(1):e055367. Epub 2022 Jan 12.

Department of Medicine, Division of Nephrology, Multi-organ Transplant Program, Montreal, Québec, Canada

Objectives: The COVID-19 pandemic significantly affected the provisions of health services to necessary but deprioritised fields, such as transplantation. Many programmes had to ramp-down their activity, which may significantly affect transplant volumes. We aimed to pragmatically analyse measures of transplant activity and compare them by a country's income level and cumulative COVID-19 incidence (CCI).

Design, Setting And Participants: From June to September 2020, we surveyed transplant physicians identified as key informants in their programmes. Of the 1267 eligible physicians, 40.5% from 71 countries participated.

Outcome: Four pragmatic measures of transplant activity.

Results: Overall, 46.5% of the programmes from high-income countries anticipate being able to maintain >75% of their transplant volume compared with 31.6% of the programmes from upper-middle-income countries, and with 21.7% from low/lower-middle-income countries (p<0.001). This could be because more programmes in high-income countries reported being able to perform transplantation/s (86.8%%-58.5%-67.9%, p<0.001), maintain prepandemic deceased donor offers (31.0%%-14.2%-26.4%, p<0.01) and avoid a ramp down phase (30.9%%-19.7%-8.3%, p<0.001), respectively. In a multivariable analysis that adjusted for CCI, programmes in upper-middle-income countries (adjusted OR, aOR=0.47, 95% CI 0.27 to 0.81) and low/lower-middle-income countries (aOR 0.33, 95% CI 0.16 to 0.67) had lower odds of being able to maintain >75% of their transplant volume, compared with programmes in high-income countries. Again, this could be attributed to lower-income being associated with 3.3-3.9 higher odds of performing no transplantation/s, 66%-68% lower odds of maintaining prepandemic donor offers and 37%-76% lower odds of avoiding ramp-down of transplantation. Overall, CCI was not associated with these measures.

Conclusions: The impact of the pandemic on transplantation was more in lower-income countries, independent of the COVID-19 burden. Given the lag of 1-2 years in objective data being reported by global registries, our findings may inform practice and policy. Transplant programmes in lower-income countries may need more effort to rebuild disrupted services and recuperate from the pandemic even if their COVID-19 burden was low.
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http://dx.doi.org/10.1136/bmjopen-2021-055367DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8756076PMC
January 2022

Exploring the perspectives of primary care providers on use of the electronic Patient Reported Outcomes tool to support goal-oriented care: a qualitative study.

BMC Med Inform Decis Mak 2021 12 29;21(1):366. Epub 2021 Dec 29.

Bridgepoint Collaboratory for Research and Innovation, Lunenfeld-Tanenbaum Research Institute, Sinai Health, Toronto, ON, Canada.

Background: Digital health technologies can support primary care delivery, but clinical uptake in primary care is limited. This study explores enablers and barriers experienced by primary care providers when adopting new digital health technologies, using the example of the electronic Patient Reported Outcome (ePRO) tool; a mobile application and web portal designed to support goal-oriented care. To better understand implementation drivers and barriers primary care providers' usage behaviours are compared to their perspectives on ePRO utility and fit to support care for patients with complex care needs.

Methods: This qualitative sub-analysis was part of a larger trial evaluating the use of the ePRO tool in primary care. Qualitative interviews were conducted with providers at the midpoint (i.e. 4.5-6 months after ePRO implementation) and end-point (i.e. 9-12 months after ePRO implementation) of the trial. Interviews explored providers' experiences and perceptions of integrating the tool within their clinical practice. Interview data were analyzed using a hybrid thematic analysis and guided by the Technology Acceptance Model. Data from thirteen providers from three distinct primary care sites were included in the presented study.

Results: Three core themes were identified: (1) Perceived usefulness: perceptions of the tool's alignment with providers' typical approach to care, impact and value and fit with existing workflows influenced providers' intention to use the tool and usage behaviour; (2) Behavioural intention: providers had a high or low behavioural intention, and for some, it changed over time; and (3) Improving usage behaviour: enabling external factors and enhancing the tool's perceived ease of use may improve usage behaviour.

Conclusions: Multiple refinements/iterations of the ePRO tool (e.g. enhancing the tool's alignment with provider workflows and functions) may be needed to enhance providers' usage behaviour, perceived usefulness and behavioural intention. Enabling external factors, such as organizational and IT support, are also necessary to increase providers' usage behaviour. Lessons from this study advance knowledge of technology implementation in primary care.

Trial Registration: Clinicaltrials.gov Identified NCT02917954. Registered September 2016, https://www.clinicaltrials.gov/ct2/show/study/NCT02917954.
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http://dx.doi.org/10.1186/s12911-021-01734-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8714873PMC
December 2021

Use of serotonin reuptake inhibitor antidepressants and the risk of bleeding complications in patients on anticoagulant or antiplatelet agents: a systematic review and meta-analysis.

Ann Med 2022 Dec;54(1):80-97

Pharmacoepidemiology and Statistics Research Center (PESRC), Faculty of Pharmacy, Chiang Mai University, Chiang Mai, Thailand.

Background: Serotonin reuptake inhibitor (SRI) antidepressants are implicated in increasing the risk of bleeding among users; however, the comparative increase in bleeding risk with concurrent antithrombotic therapy (anticoagulant or antiplatelet) remains unclear. As such, we performed a systematic review and meta-analysis of all available evidence to evaluate the effects of SRI and the risk of bleeding complications among patients receiving antithrombotic therapy.

Methods: We searched Medline, Embase, PubMed, PsycINFO, Cochrane Library, Web of Science, Scopus, CINAHL, and grey literature (Google Scholar and preprint reports) up to 26 November, 2020, with no language restrictions (updated on 31 July 2021). The primary outcome of interest was major bleeding. Secondary outcomes included intracranial haemorrhage, gastrointestinal bleeding, and any bleeding events. We used a random-effects model meta-analysis to estimate the odds ratios (ORs) and 95% confidence intervals (CIs).

Results: We did not identify any randomised studies but found 32 non-randomized studies (cohort or case-control) with 1,848,285 patients that fulfilled the study selection criteria and were included in the meta-analysis. Among individuals receiving anticoagulants (13 studies), SRI users experienced a statistically higher risk of major bleeding compared to non-SRI users: pooled OR was 1.39 (95% CI, 1.23-1.58;  < .001; moderate heterogeneity). Among individuals receiving antiplatelet therapy (2 studies), SRI users were associated with an increased risk of major bleeding: pooled OR was 1.45 (95% CI, 1.17-1.80;  = .001; low heterogeneity). For secondary outcomes, the use of SRI among individuals treated with antithrombotic therapy revealed a higher risk of gastrointestinal bleeding or any bleeding events, whereas only anticoagulant use was illustrated an increased risk of intracranial haemorrhage.

Conclusions: The use of SRI antidepressants among patients treated with antithrombotic therapy (either anticoagulant or antiplatelet) is associated with a higher risk of bleeding complications, suggesting that caution is warranted in co-prescription.

Prospero Registration: CRD42018083917KEY MESSAGESIn this meta-analysis of 32 non-randomized studies, SRI users were associated with the risk of bleeding complications compared to non-SRI users, with concurrent antithrombotic use (either anticoagulant or antiplatelet).The risk was consistently elevated across types of bleeding events (major bleeding, gastrointestinal bleeding, or any bleeding events), whereas only anticoagulant use was associated with intracranial haemorrhage.To promote the rational use of medicines, our findings suggest that the risk-benefit ratio must account for the clear efficacy of SRI against safety concerns in terms of bleeding risks.
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http://dx.doi.org/10.1080/07853890.2021.2017474DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8725830PMC
December 2022

A Randomized Double-Blind Placebo-Control Feasibility Trial of Immunoglobulin Treatment for Prevention of Recurrent Acute Exacerbations of COPD.

Int J Chron Obstruct Pulmon Dis 2021;16:3275-3284. Epub 2021 Dec 3.

Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.

Background: Observational studies suggest that immunoglobulin treatment may reduce the frequency of acute exacerbations of COPD (AECOPD).

Objective: To inform the design of a future randomised control trial (RCT) of intravenous immunoglobulin (IVIG) treatment efficacy for AECOPD prevention.

Methods: A pilot RCT was conducted. We recruited patients with COPD hospitalized for AECOPD, or from ambulatory clinics with one severe, or two moderate AECOPD in the previous year regardless of their serum IgG level. Patients were allocated in a 1:1 ratio with balanced randomisation to monthly IVIG or normal saline for 1 year. The primary outcome was feasibility defined as pre-specified accrual, adherence, and follow-up rates. Secondary outcomes included safety, tolerance, AECOPD rates, time to first AECOPD, quality of life, and healthcare costs.

Results: Seventy patients were randomized (37 female; mean age 67.7; mean FEV1 35.1%). Recruitment averaged 4.5±0.9 patients per month (range 0-8), 34 (49%) adhered to at least 80% of planned treatments, and four (5.7%) were lost to follow-up. There were 35 serious adverse events including seven deaths and one thromboembolism. None was related to IVIG. There were 56 and 48 moderate and severe AECOPD in the IVIG vs control groups. In patients with at least 80% treatment adherence, median time to first moderate or severe AECOPD was 275 vs 114 days, favoring the IVIG group (HR 0.76, 95% CI 0.3-1.92).

Conclusion: The study met feasibility criteria for recruitment and retention, but adherence was low. A trend toward more robust treatment efficacy in adherent patients supports further study, but future trials must address treatment adherence.

Trial Registration Number: NCT0290038, registered 24 February 2016, https://clinicaltrials.gov/ct2/show/NCT02690038 and NCT03018652, registered January 12, 2017, https://clinicaltrials.gov/ct2/show/NCT03018652.
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http://dx.doi.org/10.2147/COPD.S338849DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8650772PMC
March 2022

Exploring the relationship between the usability of a goal-oriented mobile health application and non-usage attrition in patients with multimorbidity: A blended data analysis approach.

Digit Health 2021 Jan-Dec;7:20552076211045579. Epub 2021 Oct 5.

Institute of Health Policy, Management, and Evaluation, University of Toronto, Canada.

Background: Mobile health applications are increasingly used to support the delivery of health care services to a variety of patients. Based on data obtained from a pragmatic trial of the electronic Patient Reported Outcome (ePRO) app designed to support goal-oriented care primary care, this study aims to (1) examine how patient-reported usability changed over the one-year intervention period, and (2) explore participant attrition rate of the electronic Patient Reported Outcome app over one year study period.

Methods: We performed a secondary analysis of 44 older adults with complex chronic needs enrolled in the electronic Patient Reported Outcome-digital health intervention. App usage and attrition were measured using device-generated usage logs; usability was measured using the patient-reported post-study system usability questionnaire collected at 3, 6, 9, and 12 months. Research memos were used to interpret potential contextual contributing factors to patients' overall usage and usability score pattern. A data triangulation method of both quantitative and qualitative data was used to analyze and interpret study findings.

Results: While there was gradual attrition in the use of the ePRO app, patients' usability scores remained consistent throughout the study period. Qualitative memos suggested patients' encounters with technical difficulties and relationship dynamics with primary providers influenced patients' adherence to the ePRO app.

Conclusion: This study highlights that the patient-provider relationship is a key determining factor that influences complex patients' continued engagement with a Mobile health app. The finding calls attention to the measurement of usability of a Mobile health app, its impact on attrition, and contributing factors that influence patients' attrition. Trial registration: Clinicaltrials.gov Identified NCT02917954.
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http://dx.doi.org/10.1177/20552076211045579DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8642112PMC
October 2021

Assessing the Implementation and Effectiveness of the Electronic Patient-Reported Outcome Tool for Older Adults With Complex Care Needs: Mixed Methods Study.

J Med Internet Res 2021 12 2;23(12):e29071. Epub 2021 Dec 2.

Institute of Health Policy, Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.

Background: Goal-oriented care is being adopted to deliver person-centered primary care to older adults with multimorbidity and complex care needs. Although this model holds promise, its implementation remains a challenge. Digital health solutions may enable processes to improve adoption; however, they require evaluation to determine feasibility and impact.

Objective: This study aims to evaluate the implementation and effectiveness of the electronic Patient-Reported Outcome (ePRO) mobile app and portal system, designed to enable goal-oriented care delivery in interprofessional primary care practices. The research questions driving this study are as follows: Does ePRO improve quality of life and self-management in older adults with complex needs? What mechanisms are likely driving observed outcomes?

Methods: A multimethod, pragmatic randomized controlled trial using a stepped-wedge design and ethnographic case studies was conducted over a 15-month period in 6 comprehensive primary care practices across Ontario with a target enrollment of 176 patients. The 6 practices were randomized into either early (3-month control period; 12-month intervention) or late (6-month control period; 9-month intervention) groups. The primary outcome measure of interest was the Assessment of Quality of Life-4D (AQoL-4D). Data were collected at baseline and at 3 monthly intervals for the duration of the trial. Ethnographic data included observations and interviews with patients and providers at the midpoint and end of the intervention. Outcome data were analyzed using linear models conducted at the individual level, accounting for cluster effects at the practice level, and ethnographic data were analyzed using qualitative description and framework analysis methods.

Results: Recruitment challenges resulted in fewer sites and participants than expected; of the 176 target, only 142 (80.6%) patients were identified as eligible to participate because of lower-than-expected provider participation and fewer-than-expected patients willing to participate or perceived as ready to engage in goal-setting. Of the 142 patients approached, 45 (32%) participated. Patients set a variety of goals related to self-management, mental health, social health, and overall well-being. Owing to underpowering, the impact of ePRO on quality of life could not be definitively assessed; however, the intervention group, ePRO plus usual care (mean 15.28, SD 18.60) demonstrated a nonsignificant decrease in quality of life (t=-1.20; P=.24) when compared with usual care only (mean 21.76, SD 2.17). The ethnographic data reveal a complex implementation process in which the meaningfulness (or coherence) of the technology to individuals' lives and work acted as a key driver of adoption and tool appraisal.

Conclusions: This trial experienced many unexpected and significant implementation challenges related to recruitment and engagement. Future studies could be improved through better alignment of the research methods and intervention to the complex and diverse clinical settings, dynamic goal-oriented care process, and readiness of provider and patient participants.

Trial Registration: ClinicalTrials.gov NCT02917954; https://clinicaltrials.gov/ct2/show/NCT02917954.
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http://dx.doi.org/10.2196/29071DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8726765PMC
December 2021

Economic evaluation of advanced practice physiotherapy models of care: a systematic review with meta-analyses.

BMC Health Serv Res 2021 Nov 9;21(1):1214. Epub 2021 Nov 9.

School of Rehabilitation, Faculty of Medicine, Université de Montréal, Montreal, Quebec, Canada.

Background: The objective of this systematic review is to appraise evidence on the economic evaluations of advanced practice physiotherapy (APP) care compared to usual medical care.

Methods: Systematic searches were conducted up to September 2021 in selected electronic bibliographical databases. Economic evaluation studies on an APP model of care were included. Economic data such as health care costs, patient costs, productivity losses were extracted. Methodological quality of included studies was assessed with the Effective Public Health Practice Project tool and the Critical Appraisal Skills Programme checklist. Meta-analyses were performed and mean differences (MD) in costs per patient were calculated using random-effect inverse variance models. Certainty of the evidence was assessed with the GRADE Approach.

Results: Twelve studies (n = 14,649 participants) including four randomized controlled trials, seven analytical cohort studies and one economic modeling study were included. The clinical settings of APP models of care included primary, emergency and specialized secondary care such as orthopaedics, paediatrics and gynaecology. The majority of the included participants were adults with musculoskeletal disorders (n = 12,915). Based on low quality evidence, health system costs including salaries, diagnostic tests, medications, and follow-up visits were significantly lower with APP care than with usual medical care, at 2 to 12-month follow-up (MD: - 145.02 €/patient; 95%CI: - 251.89 to - 38.14; n = 7648). Based on low quality evidence, patient costs including travel and paid medication prescriptions, or treatments were significantly higher with APP care compared to usual medical care, at 2 to 6-month follow-up (MD: 22.18 €/patient; 95%CI: 0.40 to 43.96; n = 1485). Based on very low quality evidence, no significant differences in productivity losses per patient were reported between both types of care (MD: 450 €/patient; 95%CI: - 80 to 970; n = 819).

Conclusions: This is the first systematic review and meta-analysis on the economic evaluation of APP models of care. Low quality evidence suggests that APP care might result in lower health care costs, but higher patient costs compared to usual medical care. Costs differences may vary depending on various factors such as the cost methodology used and on the clinical setting. More evidence is needed to evaluate cost benefits of APP models of care.
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http://dx.doi.org/10.1186/s12913-021-07221-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8579553PMC
November 2021

Long-Term Risk of Major Bleeding after Discontinuing Anticoagulation for Unprovoked Venous Thromboembolism: A Systematic Review and Meta-analysis.

Thromb Haemost 2021 Nov 9. Epub 2021 Nov 9.

School of Epidemiology and Public Health, University of Ottawa, Ottawa, Canada.

Background:  The long-term risk of major bleeding after discontinuing anticoagulant therapy for a first unprovoked venous thromboembolism (VTE) is uncertain.

Objectives:  To determine the incidence of major bleeding up to 5 years after discontinuing anticoagulation for a first unprovoked VTE.

Methods:  We searched MEDLINE, EMBASE, and Cochrane CENTRAL (from inception to January 2021) to identify relevant randomized controlled trials (RCTs) and prospective cohort studies reporting major bleeding after discontinuing anticoagulation in patients with a first unprovoked or weakly provoked VTE who had completed (IMAGE_)3 months of initial treatment. Unpublished data on major bleeding events and person-years were obtained from authors of included studies to calculate study-level incidence rates. Random-effects meta-analysis was used to pool results across studies.

Results:  Of 1,123 records identified by the search, 20 studies (17 RCTs) and 8,740 patients were included in the analysis. During 13,011 person-years of follow-up after discontinuing anticoagulation, the pooled incidence of major bleeding ( = 41) and fatal bleeding ( = 7) per 100 person-years was 0.35 (95% confidence interval [CI]: 0.20-0.54) and 0.09 (95% CI: 0.05-0.15). The 5-year cumulative incidence of major bleeding was of 1.0% (95% CI: 0.4-2.4%). The case-fatality rate of major bleeding after discontinuing anticoagulation was 19.9% (95% CI: 10.6-31.1%).

Conclusion:  The risk of major bleeding once anticoagulants are discontinued in patients with a first unprovoked VTE is not zero. Estimates from this study can help clinicians counsel patients about the incremental risk of major bleeding with extended anticoagulation to guide decision making about treatment duration for unprovoked VTE.
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http://dx.doi.org/10.1055/a-1690-8728DOI Listing
November 2021

COVID-19 Public Stigma Scale (COVID-PSS): development, validation, psychometric analysis and interpretation.

BMJ Open 2021 11 2;11(11):e048241. Epub 2021 Nov 2.

Department of Psychiatry, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.

Objective: Amid the COVID-19 pandemic, social stigma towards COVID-19 infection has become a major component of public discourse and social phenomena. As such, we aimed to develop and validate the COVID-19 Public Stigma Scale (COVID-PSS).

Design And Setting: National-based survey cross-sectional study during the lockdown in Thailand.

Participants: We invited the 4004 adult public to complete a set of measurement tools, including the COVID-PSS, global fear of COVID-19, perceived risk of COVID-19 infection, Bogardus Social Distance Scale, Pain Intensity Scale and Insomnia Severity Index.

Methods: Factor structure dimensionality was constructed and reaffirmed with model fit by exploratory and confirmatory factor analyses and non-parametric item response theory (IRT) analysis. Psychometric properties for validity and reliability were tested. An anchor-based approach was performed for classifying the proper cut-off scores.

Results: After factor analysis, IRT analysis and test for model fit, we created the final 10-item COVID-PSS with a three-factor structure: stereotype, prejudice and fear. Face and content validity were established through the public and experts' perspectives. The COVID-PSS was significantly correlated (Spearman rank, 95% CI) with the global fear of COVID-19 (0.68, 95% CI 0.66 to 0.70), perceived risk of COVID-19 infection (0.79, 95% CI 0.77 to 0.80) and the Bogardus Social Distance Scale (0.50, 95% CI 0.48 to 0.53), indicating good convergent validity. The correlation statistics between the COVID-PSS and the Pain Intensity Scale and Insomnia Severity Index were <0.2, supporting the discriminant validity. The reliability of the COVID-PSS was satisfactory, with good internal consistency (Cronbach's α of 0.85, 95% CI 0.84 to 0.86) and test-retest reproducibility (intraclass correlation of 0.94, 95% CI 0.86 to 0.96). The proposed cut-off scores were as follows: no/minimal (≤18), moderate (19-25) and high (≥26) public stigma towards COVID-19 infection.

Conclusions: The COVID-PSS is practical and suitable for measuring stigma towards COVID-19 in a public health survey. However, cross-cultural adaptation may be needed.
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http://dx.doi.org/10.1136/bmjopen-2020-048241DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8568532PMC
November 2021

Audit feedback interventions to address high-risk prescriptions in long-term care homes: a costing study and return on investment analysis.

Implement Sci Commun 2021 Oct 28;2(1):125. Epub 2021 Oct 28.

ICES, Toronto, Ontario, Canada.

Background: Audit and feedback is a common implementation strategy, but few studies describe its costs. 'MyPractice' is a province-wide audit and feedback initiative to improve prescribing in nursing homes. This study sought to estimate the costs of 'MyPractice' and assess whether the financial benefit of 'MyPractice' offsets those costs.

Methods: We conducted a costing study from the perspective of the Ontario government. Total cost of 'MyPractice' was calculated as the sum of the costs of producing and disseminating the reports (covering three report releases) which were obtained from Ontario Health staff interviews and document reviews. Return on investment (ROI) was calculated as the ratio of net cost-savings and the intervention cost. Cost savings were based on the effectiveness of 'MyPractice' derived from a published cohort study. Cost-savings attributable to 'MyPractice' were estimated from the changes in the rates of antipsychotics over time between physicians who signed up and viewed the reports and those who did not sign up to the reports.

Results: Total intervention costs were C$223,691 (C$838 per physician and C$74,564 per release). Costs incurred during the development phase accounted for 74% of the total cost (C$166,117), while implementation costs for three report releases were responsible for 26% of the total costs (C$57,575). The ROI for every C$1 spent on the 'MyPractice' intervention was 1.02 (95% CI 0.51, 1.93) for three report releases.

Conclusion: 'MyPractice' report offers a good return on investment and the value for money could improve with greater number of report releases.
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http://dx.doi.org/10.1186/s43058-021-00225-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8554856PMC
October 2021

Primary Bankart Repair Versus Arthroscopic Anatomic Glenoid Reconstruction in Patients with Subcritical Bone Loss: A Cost-Utility Analysis.

JB JS Open Access 2021 Oct-Dec;6(4). Epub 2021 Oct 21.

Department of Surgery, Dalhousie University, Halifax, Nova Scotia, Canada.

Anterior shoulder instability and its treatment is a quickly evolving field of interest in orthopaedics, both for patients and for health-care systems. In this study, we aimed to evaluate the cost-effectiveness of arthroscopic anatomic glenoid reconstruction (AAGR) compared with Bankart repair in the treatment of anterior shoulder instability in patients with subcritical glenoid bone loss.

Methods: A cost-utility analysis was performed from the perspective of Canada's publicly funded health-care system. A decision-tree model was created to simulate the progression of patients undergoing either a primary Bankart repair or AAGR. Recently published data were used to determine the recurrence rate and level of glenoid bone loss for the AAGR procedure; the recurrence rate was 1.4% in a cohort with a mean glenoid bone loss of 25.3%. A literature review on the primary Bankart procedure in patients with at least subcritical levels of glenoid bone loss yielded a recurrence rate of 22.9% in patients with a mean glenoid bone loss of 17.5%. AAGR served as the revision surgery for both primary procedures. Health utility scores for anterior shoulder instability were obtained from published literature. Total procedure costs, including costs of operating-room consumables, anesthesia, diagnostic imaging, and rehabilitation, were sourced from a hospital database. A probabilistic sensitivity analysis using 5,000 Monte Carlo simulations was performed, and results were used to create a cost-effectiveness acceptability curve.

Results: The AAGR procedure was less costly and led to an improvement in quality-adjusted life years (QALYs) when compared with the arthroscopic Bankart repair in the treatment of patients with anterior shoulder instability with subcritical glenoid bone loss (AAGR, cost = $16,682.77 [Canadian dollars] and QALYs = 5.76; Bankart, cost = $16,720.29 and QALYs = 5.46), suggesting that the AAGR is dominant, i.e., lower costs with higher QALYs. Applying a commonly used willingness-to-pay threshold of $50,000 per QALY gained, the probability that the primary AAGR was more cost-effective was 85.8%.

Conclusions: This study showed that, from the perspective of a publicly funded health-care system, AAGR was the economical treatment option when compared with Bankart repair in anterior shoulder instability with subcritical glenoid bone loss.

Level Of Evidence: Economic and Decision Analysis Level III. See Instructions for Authors for a complete description of levels of evidence.
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http://dx.doi.org/10.2106/JBJS.OA.21.00067DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8542168PMC
October 2021

Impact of Pharmacological Treatments for Chronic Spontaneous Urticaria with an Inadequate Response to H1-Antihistamines on Health-Related Quality of Life: A Systematic Review and Network Meta-Analysis.

J Allergy Clin Immunol Pract 2022 01 22;10(1):297-308. Epub 2021 Oct 22.

Pharmacoepidemiology and Statistics Research Center (PESRC), Faculty of Pharmacy, Chiang Mai University, Chiang Mai, Thailand; Ottawa Hospital Research Institute, Ottawa Hospital, Ottawa, ON, Canada; Institute of Clinical and Evaluative Sciences, ICES uOttawa, Ottawa, ON, Canada; School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada.

Background: Recently, pharmacological treatment options for H1-antihistamine-refractory chronic spontaneous urticaria have increased dramatically; however, their effects on patient-reported outcomes, including health-related quality of life (HRQOL), remain unclear.

Objective: To compare the impact of these treatments on HRQOL among H1-antihistamine-refractory patients with chronic spontaneous urticaria.

Methods: We completed a comprehensive search of the available literature in the electronic databases, gray literature, and preprint reports up to April 19, 2021, with no language restrictions. The primary outcome for evaluation was a change in HRQOL from the baseline, and secondary outcomes included patient unacceptability and other patient-reported outcomes. We used a random-effects network meta-analysis and estimated differences in standardized mean differences (SMDs) and odds ratios with 95% CIs. Evidence-based synthesis was based on magnitudes of effect size, evidence certainty, ranking of treatment effects, and clinically meaningful improvement.

Results: Twelve randomized controlled trials encompassing 1866 adolescent and adult patients were included. Our evidence synthesis analyses revealed that hydroxychloroquine (SMD, -1.00 [-1.61 to -0.39]), 72 mg ligelizumab (SMD, -0.66 [-0.96 to -0.35]), 240 mg ligelizumab (SMD, -0.67 [-0.98 to -0.37]), and 300 mg omalizumab (SMD, -0.53 [-0.67 to -0.39]) significantly improved HRQOL with a moderate beneficial effect. However, the use of hydroxychloroquine seems to be limited by a higher risk of patient unacceptability of treatment. Other secondary outcomes remain inconclusive based on the available evidence.

Conclusions: Both ligelizumab (72 or 240 mg) and 300 mg omalizumab appeared to be effective treatments for H1-antihistamine-refractory chronic spontaneous urticaria, because they were closely associated with improved HRQOL.
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http://dx.doi.org/10.1016/j.jaip.2021.10.022DOI Listing
January 2022
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