Browsing by Author "James, Matthew T"

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    Challenges and potential solutions to the evaluation, monitoring, and regulation of surgical innovations
    (2019-08-27) Roberts, Derek J; Zygun, David A; Ball, Chad G; Kirkpatrick, Andrew W; Faris, Peter D; James, Matthew T; Mrklas, Kelly J; Hemmelgarn, Brenda D; Manns, Braden; Stelfox, Henry T
    Abstract Background As it may be argued that many surgical interventions provide obvious patient benefits, formal, staged assessment of the efficacy and safety of surgical procedures has historically been and remains uncommon. The majority of innovative surgical procedures have therefore often been developed based on anatomical and pathophysiological principles in an attempt to better manage clinical problems. Main Body In this manuscript, we sought to review and contrast the models for pharmaceutical and surgical innovation in North America, including their stages of development and methods of evaluation, monitoring, and regulation. We also aimed to review the present structure of academic surgery, the role of methodological experts and funding in conducting surgical research, and the current system of regulation of innovative surgical procedures. Finally, we highlight the influence that evidence and surgical history, education, training, and culture have on elective and emergency surgical decision-making. The above discussion is used to support the argument that the model used for assessment of innovative pharmaceuticals cannot be applied to that for evaluating surgical innovations. It is also used to support our position that although the evaluation and monitoring of innovative surgical procedures requires a rigorous, fit-for-purpose, and formal system of assessment to protect patient safety and prevent unexpected adverse health outcomes, it will only succeed if it is supported and championed by surgical practice leaders and respects surgical history, education, training, and culture. Conclusion We conclude the above debate by providing a recommended approach to the evaluation, monitoring, and regulation of surgical innovations, which we hope may be used as a guide for all stakeholders involved in interpreting and/or conducting future surgical research.
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    Correction to: Methods for identifying 30 chronic conditions: application to administrative data
    (2019-09-04) Tonelli, Marcello; Wiebe, Natasha; Fortin, Martin; Guthrie, Bruce; Hemmelgarn, Brenda R; James, Matthew T; Klarenbach, Scott W; Lewanczuk, Richard; Manns, Braden J; Ronksley, Paul; Sargious, Peter; Straus, Sharon; Quan, Hude
    Following publication of the original manuscript [1], the authors noted several errors in Table 1. Details of the requested corrections are shown below:
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    Development and initial implementation of electronic clinical decision supports for recognition and management of hospital-acquired acute kidney injury
    (2020-11-04) Howarth, Megan; Bhatt, Meha; Benterud, Eleanor; Wolska, Anna; Minty, Evan; Choi, Kyoo-Yoon; Devrome, Andrea; Harrison, Tyrone G; Baylis, Barry; Dixon, Elijah; Datta, Indraneel; Pannu, Neesh; James, Matthew T
    Abstract Background Acute kidney injury (AKI) is common in hospitalized patients and is associated with poor patient outcomes and high costs of care. The implementation of clinical decision support tools within electronic medical record (EMR) could improve AKI care and outcomes. While clinical decision support tools have the potential to enhance recognition and management of AKI, there is limited description in the literature of how these tools were developed and whether they meet end-user expectations. Methods We developed and evaluated the content, acceptability, and usability of electronic clinical decision support tools for AKI care. Multi-component tools were developed within a hospital EMR (Sunrise Clinical Manager™, Allscripts Healthcare Solutions Inc.) currently deployed in Calgary, Alberta, and included: AKI stage alerts, AKI adverse medication warnings, AKI clinical summary dashboard, and an AKI order set. The clinical decision support was developed for use by multiple healthcare providers at the time and point of care on general medical and surgical units. Functional and usability testing for the alerts and clinical summary dashboard was conducted via in-person evaluation sessions, interviews, and surveys of care providers. Formal user acceptance testing with clinical end-users, including physicians and nursing staff, was conducted to evaluate the AKI order set. Results Considerations for appropriate deployment of both non-disruptive and interruptive functions was important to gain acceptability by clinicians. Functional testing and usability surveys for the alerts and clinical summary dashboard indicated that the tools were operating as desired and 74% (17/23) of surveyed healthcare providers reported that these tools were easy to use and could be learned quickly. Over three-quarters of providers (18/23) reported that they would utilize the tools in their practice. Three-quarters of the participants (13/17) in user acceptance testing agreed that recommendations within the order set were useful. Overall, 88% (15/17) believed that the order set would improve the care and management of AKI patients. Conclusions Development and testing of EMR-based decision support tools for AKI with clinicians led to high acceptance by clinical end-users. Subsequent implementation within clinical environments will require end-user education and engagement in system-level initiatives to use the tools to improve care.
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    Joint associations of obesity and estimated GFR with clinical outcomes: a population-based cohort study
    (2019-06-06) Tonelli, Marcello; Wiebe, Natasha; Kovesdy, Csaba P; James, Matthew T; Klarenbach, Scott W; Manns, Braden J; Hemmelgarn, Brenda R
    Abstract Background Despite the interrelationships between obesity, eGFR and albuminuria, few large studies examine how obesity modifies the association between these markers of kidney function and adverse clinical outcomes. Methods We examined the joint associations between obesity, eGFR and albuminuria on four clinical outcomes (death, end-stage renal disease [ESRD], myocardial infarction [MI], and placement in a long-term care facility) using a population-based cohort with procedures from Alberta. Obesity was defined by body mass index ≥35 kg/m2 as defined by a fee modifier applied to an eligible procedure. Results We studied 1,293,362 participants, of whom 171,650 (13.3%) had documented obesity (BMI ≥ 35 kg/m2 based on claims data) and 1,121,712 (86.7%) did not. The association between eGFR and death was J-shaped for participants with and without documented obesity. After full adjustment, obesity tended to be associated with slightly lower odds of mortality (OR range 0.71–1.02; p for interaction between obesity and eGFR 0.008). For participants with and without obesity, the adjusted odds of ESRD were lowest for participants with eGFR > 90 mL/min*1.73m2 and increased with lower eGFR, with no evidence of an interaction with obesity (p = 0.37). Although albuminuria and obesity were both associated with higher odds of ESRD, the excess risk associated with obesity was substantially attenuated at higher levels of albuminuria (p for interaction 0.0006). The excess risk of MI associated with obesity was observed at eGFR > 60 mL/min*1.73m2 but not at lower eGFR (p for interaction < 0.0001). Participants with obesity had a higher adjusted likelihood of placement in long-term care than those without, and the likelihood of such placement was higher at lower eGFR for those with and without obesity (p for interaction = 0.57). Conclusions We found significant interactions between obesity and eGFR and/or albuminuria on the likelihood of adverse outcomes including death and ESRD. Since obesity is common, risk prediction tools for people with CKD might be improved by adding information on BMI or other proxies for body size in addition to eGFR and albuminuria.
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    Patient perspectives on engagement in decision-making in early management of non-ST elevation acute coronary syndrome: a qualitative study
    (2017-11-28) Wilson, Todd; Miller, Jean; Teare, Sylvia; Penman, Colin; Pearson, Winnie; Marlett, Nancy J; Shklarov, Svetlana; Diane Galbraith, P.; Southern, Danielle A; Knudtson, Merril L; Norris, Colleen M; James, Matthew T; Wilton, Stephen B
    Abstract Background Surveys of patients suggest many want to be actively involved in treatment decisions for acute coronary syndromes. However, patient experiences of their engagement and participation in early phase decision-making have not been well described. Methods We performed a patient led qualitative study to explore patient experiences with decision-making processes when admitted to hospital with non-ST elevation acute coronary syndrome. Trained patient-researchers conducted the study via a three-phase approach using focus groups and semi-structured interviews and employing grounded theory methodology. Results Twenty patients discharged within one year of a non-ST elevation acute coronary syndrome participated in the study. Several common themes emerged. First, patients characterized the admission and early treatment of ACS as a rapidly unfolding process where they had little control. Participants felt they played a passive role in early phase decision-making. Furthermore, participants described feeling reduced capacity for decision-making owing to fear and mental stress from acute illness, and therefore most but not all participants were relieved that expert clinicians made decisions for them. Finally, once past the emergent phase of care, participants wanted to retake a more active role in their treatment and follow-up plans. Conclusions Patients admitted with ACS often do not take an active role in initial clinical decisions, and are satisfied to allow the medical team to direct early phase care. These results provide important insight relevant to designing patient-centered interventions in ACS and other urgent care situations.
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    Psychometric evaluation of a Canadian version of the Seattle Angina Questionnaire (SAQ-CAN)
    (2020-12-01) Lawal, Oluwaseyi A; Awosoga, Oluwagbohunmi; Santana, Maria J; James, Matthew T; Southern, Danielle A; Wilton, Stephen B; Graham, Michelle M; Knudtson, Merrill; Lu, Mingshan; Quan, Hude; Ghali, William A; Norris, Colleen M; Sajobi, Tolulope
    Abstract Background The Seattle Angina Questionnaire (SAQ) is a widely-used patient-reported outcomes measure in patients with heart disease. This study assesses the validity and reliability of the SAQ in a Canadian cohort of individuals with stable angina. Methods and results Data are from the Alberta Provincial Project for Outcome Assessment in Coronary Heart Disease (APPROACH) registry, a population-based registry of patients who received cardiac catheterization in Alberta, Canada. The cohort consists of 4052 patients undergoing cardiac catheterization for stable angina and completed the SAQ within 2 weeks. Exploratory factor analysis and confirmatory factor analysis (CFA) were used to assess the factorial structure of the SAQ. Internal and test–retest reliabilities of a new measure (i.e., SAQ-CAN) was measured using Cronbach α and intraclass correlation coefficient, respectively. CFA model fit was assessed using the root mean square error of approximation (RMSEA) and comparative fit index (CFI). Construct validity of the SAQ-CAN was assessed in relation to Hospital Anxiety and Depression Scales (HADS), Euro Quality of life 5 dimension (EQ5D), and original SAQ. Of the 4052 patients included in this analysis, 3281 (80.97%) were younger than 75 years old, while 3239 (79.94%) were male. Both exploratory and confirmatory factor analyses revealed a four-factorial structure consisting of 16 items that provided a better fit to the data (RMSEA = 0.049 [90% CI = (0.047, 0.052)]; CFI = 0.975). The 16-item SAQ demonstrated good to excellent internal reliability (Cronbach’s α range from 0.77 to 0.90), moderate to strong correlation with the Original SAQ and EQ5D but negligible correlations with HADS. Conclusion The SAQ-CAN has acceptable psychometric properties that are comparable to the original SAQ. We recommend its use for assessing coronary health outcomes in Canadian patients with Coronary Artery Disease.
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    Statin use and the risk of acute kidney injury in older adults
    (2019-03-25) Tonelli, Marcello; Lloyd, Anita M; Bello, Aminu K; James, Matthew T; Klarenbach, Scott W; McAlister, Finlay A; Manns, Braden J; Tsuyuki, Ross T; Hemmelgarn, Brenda R
    Abstract Background As more patients at lower cardiovascular (CV) risk are treated with statins, the balance between cardiovascular benefits and the risk of adverse events becomes increasingly important. Methods We did a population-based cohort study (May 1, 2002 to March 30, 2013) using province-wide laboratory and administrative data in Alberta. We studied new statin users aged 66 years of age and older who were not receiving renal replacement therapy at baseline. We assessed statin use at 30-day intervals to allow time-varying assessment of statin exposure in Cox proportional hazards models that examined the relation between statin use and hospitalization with acute kidney injury (AKI). Results Of the 128,140 new statin users, 47 and 46% were prescribed high- and medium-intensity regimens at the index date. During median follow-up of 4.6 years (interquartile range 2.2, 7.4), 9118 individuals were hospitalized for AKI. Compared to non-use, the use of high- and medium-intensity statin regimens was associated with significant increases in the adjusted risks of hospitalization with AKI: hazard ratios 1.16 [95% confidence interval (CI) 1.10, 1.23] and 1.07 (95% CI 1.01, 1.13), respectively. Risks of AKI were higher among women than men, and among users of angiotensin converting enzyme inhibitors/angiotensin receptor blockers than non-users, and among diuretic users (p for interaction 0.002, 0.01, and 0.04 respectively). Conclusions We found a graded, independent association between the intensity of statin use and the risk of hospitalization with AKI, although the absolute magnitude of the excess risk was small.
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    The effect and safety of postmenopausal hormone therapy and selective estrogen receptor modulators on kidney outcomes in women: a protocol for systematic review and meta-analysis
    (2017-07-07) Dumanski, Sandra M; Ramesh, Sharanya; James, Matthew T; Metcalfe, Amy; Nerenberg, Kara; Seely, Ellen W; Robertson, Helen L; Ahmed, Sofia B
    Abstract Background The prevalence of menopause in women with or at risk of chronic kidney disease is increasing globally. Although international guidelines on menopause recommend the use of postmenopausal hormone therapy with or without selective estrogen receptor modulators for control of vasomotor symptoms, the effects of these treatments on kidney function and albuminuria are unclear. Furthermore, women with chronic kidney disease are at significantly increased risk of venous thromboembolism and malignancy, well-documented adverse effects of postmenopausal hormone therapy. Our study aims to establish the effect of these treatments on kidney function and albuminuria in women, as well as determine the safety of these treatments in the chronic kidney disease population. Methods We will conduct a systematic review and meta-analysis addressing the effect and safety of postmenopausal hormone therapy and selective estrogen receptor modulators on kidney outcomes in women. We plan to search for published (MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), tables of contents of relevant journals) and unpublished (ongoing studies, conference proceedings) studies in all languages examining the effect of postmenopausal hormone therapy, including selective estrogen receptor modulators, on kidney function and albuminuria, as well as the risk of adverse outcomes of these treatments in women with chronic kidney disease. Two independent investigators will screen identified abstracts and select studies that examine the effect of postmenopausal hormone therapy and selective estrogen receptor modulators on kidney outcomes in the general population or adverse outcomes in the chronic kidney disease population. Data on study population, intervention, outcomes, as well as study quality and risk of bias will be independently extracted from each eligible study. Along with descriptive presentation of data, outcome measures will be presented as meta-analyses using a random effects model. Planned subgroup analyses will be completed, and meta-regression will be performed if significant heterogeneity is noted. Discussion By examining the effects of postmenopausal hormone therapy and selective estrogen receptor modulators on kidney function and albuminuria, the results of this systematic review and meta-analysis will inform management of postmenopausal women in the general population. Furthermore, it will evaluate the safety, including the risks of known adverse outcomes of postmenopausal hormone therapy and selective estrogen receptor modulators, in the already vulnerable chronic kidney disease population. Systematic review registration PROSPERO CRD42016050651
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    Validation of a case definition to define chronic dialysis using outpatient administrative data
    (BioMed Central, 2011-03-01) Clement, Fiona M.; James, Matthew T; Chin, Rick; Klarenbach, Scott W.; Manns, Braden J.; Quinn, Robert R.; Ravani, Pietro; Tonelli, Marcello; Hemmelgarn, Brenda R.; Alberta Kidney Disease Network