PRISM :: Browsing by Author "Manns, Braden"

Browsing by Author "Manns, Braden"

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Open Access
6-STEPPs: A Modular Tool to Facilitate Clinician Participation in Fair Decisions for Funding New Cancer Drugs
(2008) Sinclair, Shane; Browman, George P.; Manns, Braden; Hagen, Neil; Chambers, Carole R.; Simon, Anita
To design a tool to assist clinician participation with cancer drug funding decisions. Public policy-makers and insurers are struggling with funding decisions regarding increasingly expensive new cancer drugs. Increasingly, oncologists are contributing to the process of review that leads to such decisions. We were asked to design a system for ranking new cancer drugs for priority-based funding decisions.
Open Access
A cluster randomized controlled trial for the Evaluation of routinely Measured PATient reported outcomes in HemodialYsis care (EMPATHY): a study protocol
(2020-08-10) Johnson, Jeffrey A; Al Sayah, Fatima; Buzinski, Robert; Corradetti, Bonnie; Davison, Sara N; Elliott, Meghan J; Klarenbach, Scott; Manns, Braden; Schick-Makaroff, Kara; Short, Hilary; Thomas, Chandra; Walsh, Michael
Abstract Background Kidney failure requiring dialysis is associated with poor health outcomes and health-related quality of life (HRQL). Patient-reported outcome measures (PROMs) capture symptom burden, level of functioning and other outcomes from a patient perspective, and can support clinicians to monitor disease progression, address symptoms, and facilitate patient-centered care. While evidence suggests the use of PROMs in clinical practice can lead to improved patient experience in some settings, the impact on patients’ health outcomes and experiences is not fully understood, and their cost-effectiveness in clinical settings is unknown. This study aims to fill these gaps by evaluating the effectiveness and cost-effectiveness of routinely measuring PROMs on patient-reported experience, clinical outcomes, HRQL, and healthcare utilization. Methods The EMPATHY trial is a pragmatic multi-centre cluster randomized controlled trial that will implement and evaluate the use of disease-specific and generic PROMs in three kidney care programs in Canada. In-centre hemodialysis units will be randomized into four groups, whereby patients: 1) complete a disease-specific PROM; 2) complete a generic PROM; 3) complete both types of PROMs; 4) receive usual care and do not complete any PROMs. While clinical care pathways are available to all hemodialysis units in the study, for the three active intervention groups, the results of the PROMs will be linked to treatment aids for clinicians and patients. The primary outcome of this study is patient-provider communication, assessed by the Communication Assessment Tool (CAT). Secondary outcomes include patient management and symptoms, use of healthcare services, and the costs of implementing this intervention will also be estimated. The present protocol fulfilled the Standard Protocol Items: Recommendations for Intervention Trials (SPIRIT) checklist. Discussion While using PROMs in clinical practice is supported by theory and rationale, and may engage patients and enhance their role in decisions regarding their care and outcomes, the best approach of their use is still uncertain. It is important to rigorously evaluate such interventions and investments to ensure they provide value for patients and health systems. Trial registration Protocol version (1.0) and trial registration data are available on www.clinicaltrials.gov , identifier: NCT03535922 , registered May 24, 2018.
Open Access
A cost-effectiveness analysis of mupirocin and chlorhexidine gluconate for Staphylococcus aureus decolonization prior to hip and knee arthroplasty in Alberta, Canada compared to standard of care
(2019-07-11) Rennert-May, Elissa; Conly, John; Smith, Stephanie; Puloski, Shannon; Henderson, Elizabeth; Au, Flora; Manns, Braden
Abstract Background While decolonization of Staphylococcus aureus reduces surgical site infection (SSI) rates following hip and knee arthroplasty, its cost-effectiveness is uncertain. We sought to examine the cost-effectiveness of a decolonization protocol for Staphylococcus aureus prior to hip and knee replacement in Alberta compared to standard care – no decolonization. Methods Decision analytic models and a probabilistic sensitivity analysis were used for a cost-effectiveness analysis, with the effectiveness of decolonization based on a large published pre- and post- intervention trial. The primary outcomes of the models were infections prevented and health care costs. We modelled the cost-effectiveness of decolonization in a hypothetical cohort of adult patients undergoing hip and knee replacement in Alberta, Canada. Information on the incidence of complex surgical site infections (SSIs), as well as the cost of care for patients with and without SSIs was taken from a provincial infection control database, and health administrative data. Results Use of the decolonization bundle was cost saving compared to usual care ($153/person), and resulted in 16 complex Staphylococcus aureus SSIs annually as opposed to 32 (with approximately 8000 hip or knee arthroplasties performed). The probabilistic sensitivity analysis demonstrated that the majority (84%) of the time the decolonization bundle was cost saving. The model was robust to one-way sensitivity analyses conducted within plausible ranges. There were small upfront costs associated with using a decolonization protocol, however, this model demonstrated cost savings over one year. In a Markov model that considered the impact of a decolonization bundle over a lifetime as it pertained to the need for subsequent joint replacements and patient quality of life, the bundle still resulted in cost savings ($161/person). Conclusions Decolonization for Staphylococcus aureus prior to hip and knee replacements resulted in cost savings and fewer SSIs, and should be considered prior to these procedures.
Open Access
A cost-utility analysis of decompressive hemicraniectomy in patients with malignant middle cerebral artery (mca) infarction
(2009) Berthiaume, Luc Roger; Doig, Christopher J.; Manns, Braden
Decompressive hemicraniectomy improves survival in patients with large hemispheric strokes and cerebral edema, but a significant proportion of these survivors have moderate to severe disability. Given that decompressive hemicraniectomy is a very resource intensive therapy, whether it offers good value for money is an important question that has not been addressed previously. Our objective was to determine the costs and benefits of decompressive hemicraniectomy in adults with hemispheric strokes associated with cerebral edema and compare these with medical therapy as an alternative treatment strategy. Cost-utility and cost-effectiveness analyses were performed. The performance of decompressive hemicraniectomy in patients with malignant MCA infarction was associated a gain of 2.77 quality adjusted life years (QAL Ys) compared to 0.84 QAL Ys for standard care. The expected cost of a surgical strategy was CAN$ 225 931 compared to CAN$ 101 826 for standard care. The incremental cost per QAL Y gained (ICER) of treating patients with decompressive hemicraniectomy was CAN$ 64 220. When the measure of effectiveness was life years gained, the incremental cost per life year gained was CAN$ 32,180. ii Sensitivity and scenario suggest a likely ICER range of 50,000 to 100,000 dollars per QAL Y gained in appropriately selected patients. Sensitivity analyses suggest that delayed surgery (beyond 48 hours) and surgery performed in older patients could be associated with a much higher ICER. We feel that decompressive hemicraniectomy should be offered to patients with large strokes complicated by cerebral edema as it is a potentially life-saving procedure in a young patient population and it has a similar ICER when compared to therapies that are already funded within the Canadian health care system. Our study results suggest that directing this surgery towards younger patients who can be operated in within 48 hours might optimize use of resources. However, it is associated with an incremental cost and decision makers will need to weight its costs and benefits with other therapies being considered for funding. iii
Open Access
Accelerated care vs standard care of transient ischemic attack: a preliminary analysis of effectiveness and cost
(2005) Wu, Caren Marie; Manns, Braden; Buchan, Alastair M.
Open Access
An economic evaluation of sirolimus-eluting stents with expanded consideration of inputs and outputs
(2006) Shrive, Fiona; Ghali, William; Manns, Braden
Open Access
Assessing the Impact of Financial Barriers on Care and Outcomes for Patients with Cardiovascular-Related Chronic Diseases
(2017) Campbell, David John Thomas; Manns, Braden; King-Shier, Kathryn; Hemmelgarn, Brenda; Sanmartin, Claudia
Patients with cardiovascular-related chronic diseases, such as coronary artery disease and diabetes may face numerous barriers to accessing the complex care that they require. Even in Canada, which has a universal healthcare system, some patients may face financial barriers to accessing important goods and services. Our objective was to enhance the understanding of financial barriers and their impact on clinical outcomes. This thesis is comprised of four reports of three independent studies that form an overarching sequential mixed methods program of research. The first study was a population-weighted survey of Western Canadians with cardiovascular-related chronic conditions in which we found that 1 in 10 respondents perceived having financial barriers to accessing goods and services required for their chronic disease. Those who reported having a financial barrier self-reported being 70% more likely to require hospital or emergency department care than those who did not perceive having financial barriers. In the second study, we built on this by linking data for patients self-reporting financial barriers within a series of national health surveys to outcomes available within administrative data sources. Those who perceived having a financial barrier to any aspect of their care had a hospitalization rate and mortality rate that was 36% and 24% higher, respectively, than those who denied having financial barriers. In the third study, we explored patients’ experiences with financial barriers using grounded theory methodology. We developed a conceptual framework for understanding how financial barriers impact patients’ lives. We outlined protective, predisposing, and modifying factors that ultimately determine how resilient an individual can be in the face of financial barriers. Finally, we undertook a qualitative descriptive analysis to describe the aspects of care to which patients most commonly experience financial barriers. These include: non-insured goods and services, items required to support self-management and incidental expenses associated with insured services. Many Canadians with chronic diseases face financial barriers to care, which are associated with adverse health outcomes. Interventions to address the prevalence and impact of financial barriers are possible but have never been tested in rigorous trials. Such studies would inform important policy reform at all levels of government.
Open Access
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.
Open Access
Chronic kidney disease among First Nations people in Alberta: prevalence, health services utilization and access to quality care
(2006) Gao, Song; Manns, Braden; Hemmelgarn, Brenda
Open Access
Clinical activity score an an endpoint in randomized clinical trials of immunosuppressive medications in anti-neutrophil cytoplasm antibody associated vasculitis: a validation study
(2009) Walsh, Michael; Manns, Braden
Open Access
Closed Or Open after Source Control Laparotomy for Severe Complicated Intra-Abdominal Sepsis (the COOL trial): study protocol for a randomized controlled trial
(2018-06-22) Kirkpatrick, Andrew W; Coccolini, Federico; Ansaloni, Luca; Roberts, Derek J; Tolonen, Matti; McKee, Jessica L; Leppaniemi, Ari; Faris, Peter; Doig, Christopher J; Catena, Fausto; Fabian, Timothy; Jenne, Craig N; Chiara, Osvaldo; Kubes, Paul; Manns, Braden; Kluger, Yoram; Fraga, Gustavo P; Pereira, Bruno M; Diaz, Jose J; Sugrue, Michael; Moore, Ernest E; Ren, Jianan; Ball, Chad G; Coimbra, Raul; Balogh, Zsolt J; Abu-Zidan, Fikri M; Dixon, Elijah; Biffl, Walter; MacLean, Anthony; Ball, Ian; Drover, John; McBeth, Paul B; Posadas-Calleja, Juan G; Parry, Neil G; Di Saverio, Salomone; Ordonez, Carlos A; Xiao, Jimmy; Sartelli, Massimo
Abstract Background Severe complicated intra-abdominal sepsis (SCIAS) has an increasing incidence with mortality rates over 80% in some settings. Mortality typically results from disruption of the gastrointestinal tract, progressive and self-perpetuating bio-mediator generation, systemic inflammation, and multiple organ failure. Principles of treatment include early antibiotic administration and operative source control. A further therapeutic option may be open abdomen (OA) management with active negative peritoneal pressure therapy (ANPPT) to remove inflammatory ascites and ameliorate the systemic damage from SCIAS. Although there is now a biologic rationale for such an intervention as well as non-standardized and erratic clinical utilization, this remains a novel therapy with potential side effects and clinical equipoise. Methods The Closed Or Open after Laparotomy (COOL) study will constitute a prospective randomized controlled trial that will randomly allocate eligible surgical patients intra-operatively to either formal closure of the fascia or use of the OA with application of an ANPTT dressing. Patients will be eligible if they have free uncontained intra-peritoneal contamination and physiologic derangements exemplified by septic shock OR a Predisposition-Infection-Response-Organ Dysfunction Score ≥ 3 or a World-Society-of-Emergency-Surgery-Sepsis-Severity-Score ≥ 8. The primary outcome will be 90-day survival. Secondary outcomes will be logistical, physiologic, safety, bio-mediators, microbiological, quality of life, and health-care costs. Secondary outcomes will include days free of ICU, ventilation, renal replacement therapy, and hospital at 30 days from the index laparotomy. Physiologic secondary outcomes will include changes in intensive care unit illness severity scores after laparotomy. Bio-mediator outcomes for participating centers will involve measurement of interleukin (IL)-6 and IL-10, procalcitonin, activated protein C (APC), high-mobility group box protein-1, complement factors, and mitochondrial DNA. Economic outcomes will comprise standard costing for utilization of health-care resources. Discussion Although facial closure after SCIAS is considered the current standard of care, many reports are suggesting that OA management may improve outcomes in these patients. This trial will be powered to demonstrate a mortality difference in this highly lethal and morbid condition to ensure critically ill patients are receiving the best care possible and not being harmed by inappropriate therapies based on opinion only. Trial registration ClinicalTrials.gov , NCT03163095 .
Open Access
Correction to: Patient-reported outcome measures in the care of in-centre hemodialysis patients
(2021-11-03) Davison, Sara N.; Klarenbach, Scott; Manns, Braden; Schick-Makaroff, Kara; Buzinski, Robert; Corradetti, Bonnie; Short, Hilary; Johnson, Jefrey A.
Open Access
The Cost-Effectiveness of a Prevention Strategy for Clostridioides difficile Infections in Alberta Health Services
(2019-04-30) Leal, Jenine Rocha; Manns, Braden; Henderson, Elizabeth Ann; Conly, John M.; Ronksley, Paul Everett; Loeb, Mark; Noseworthy, Tom W.
The clinical and economic burden of hospital-acquired Clostridioides difficile infection (HA-CDI) is significant, however there is uncertainty in the cost-effectiveness of implementing probiotics for the primary prevention of HA-CDI among hospitalized patients prescribed antibiotics. In this thesis we examined the predictors of mortality and length of stay among this patient population in Alberta. We determined the attributable cost of HA-CDI and applied these estimates in a cost-effectiveness analysis of probiotics for the primary prevention of HA-CDI in Alberta from the perspective of a publicly-funded healthcare system. We conducted three studies: a population-based, retrospective cohort study using clinical surveillance, administrative and laboratory databases to determine the predictors of 30-day all-cause and attributable mortality and length of stay; a propensity score-matched study to compare patients with HA-CDI to patients without CDI to determine the attributable cost of HA-CDI in Alberta; and a cost-effectiveness analysis using decision analytic modelling to evaluate the costs and consequences related to probiotic use for the primary prevention of CDI. We found that the incidence and mortality rates of HA-CDI are declining, though the latter was not statistically significant. Advancing age was associated with all outcomes after adjusting for a number of baseline factors. Increased baseline white blood cell counts were associated with a lower risk of mortality. Hospital-acquired CDI total adjusted costs were 27% higher and length of stay was 13% higher than non-cases of CDI. Oral probiotics as a preventive strategy for CDI resulted in a lower risk of CDI and cost-savings. Previous studies on the burden of HA-CDI have been limited in their size and scope. Our first study was the largest population-based cohort study evaluating predictors of mortality; while our second study was the first to use propensity score-matching and a micro-costing approach for the estimation of costs associated with HA-CDI. We were the first to conduct an economic evaluation of probiotics for the primary prevention of CDI. This work will be presented to Alberta Health Services to support the evaluation of probiotics as a preventive strategy against CDI and whether to scale up probiotics to all provincial hospitals.
Open Access
Economic evaluation of colerectal cancer screening for average risk individuals
(2012) Heitman, Steven James; Manns, Braden; Hilsden, Robert
Background: Colorectal cancer (CRC) is a common deadly cancer. Screening for CRC saves lives and is cost-effective, but it is unclear if one or more of the screening options are preferred. Methods: A Markov model was developed and validated and then used to conduct an economic evaluation of CRC screening for average risk individuals. All current CRC screening modalities and up to date CRC treatment costs were considered. A systematic review and meta-analysis of CRC and adenomatous polyp prevalence was also performed to inform the model. Results: The prevalence of non-advanced adenomas, advanced adenomas and CRC in 50-64 and 65-75 year olds was 17.1%, 3.8% and 0.1% and 17.3%, 8.2% and 0.7%, respectively. In the base case analysis CRC screening with annual FIT reduced the risk of CRC and CRC-related deaths and was associated with lower health care costs compared to no screening and the other screening options. Conclusion: Health policy decision makers should prioritize funding for CRC screening using FIT.
Open Access
Economic evaluations and their use in infection prevention and control: a narrative review
(2018-02-27) Rennert-May, Elissa; Conly, John; Leal, Jenine; Smith, Stephanie; Manns, Braden
Abstract Background The objective of this review is to provide a comprehensive overview of the different types of economic evaluations that can be utilized by Infection Prevention and Control practitioners with a particular focus on the use of the quality adjusted life year, and its associated challenges. We also highlight existing economic evaluations published within Infection Prevention and Control, research gaps and future directions. Design Narrative Review. Conclusions To date the majority of economic evaluations within Infection Prevention and Control are considered partial economic evaluations. Acknowledging the challenges, which include variable utilities within infection prevention and control, a lack of randomized controlled trials, and difficulty in modelling infectious diseases in general, future economic evaluation studies should strive to be consistent with published guidelines for economic evaluations. This includes the use of quality adjusted life years. Further research is required to estimate utility scores of relevance within Infection Prevention and Control.
Open Access
Patient-reported outcome measures in the care of in-centre hemodialysis patients
(2021-10-12) Davison, Sara N.; Klarenbach, Scott; Manns, Braden; Schnick-Makaroff, Kara; Buzinski, Robert; Corradetti, Bonnie; Short, Hilary; Johnson, Jeffrey A.
Abstract Kidney failure requiring dialysis is associated with high symptom burden and low health-related quality of life (HRQL). Patient-reported outcome measures (PROMs) are standardized instruments that capture patients’ symptom burden, level of functioning, and HRQL. The routine use of PROMs can be used to monitor aspects of patients’ health that may otherwise be overlooked, inform care planning, and facilitate the introduction of treatments. Incorporating PROMs into clinical practice is an appropriate strategy to engage patients and enhance their role in decisions regarding their care and outcomes. However, the implementation of PROMs measurement and associated interventions can be challenging given the nature of clinical practice in busy hemodialysis units, the variations in organization and clinical workflow across units, as well as regional programs. Implementing PROMs and linking these with actionable treatment aids to alleviate bothersome symptoms and improve patients’ wellbeing is key to improving patients’ health. Other considerations in implementing PROMs within a hemodialysis setting include integration into electronic medical records, purchase and configuration of electronic tools (i.e., tablets), storage and disinfection of such tools, and ongoing IT resources. It is important to train clinicians on the practical elements of using PROMs, however there is also a need to engage clinicians to use PROMs on an ongoing basis. This article describes how PROMs have been implemented at in-centre hemodialysis units in Alberta, Canada, addressing each of these elements.
Open Access
Protocol for a parallel economic evaluation of a trial comparing two surgical strategies in severe complicated intra-abdominal sepsis: the COOL-cost study
(2020-02-21) Ng-Kamstra, Joshua S; Rennert-May, Elissa; McKee, Jessica; Lundgren, Skyla; Manns, Braden; Kirkpatrick, Andrew W
Abstract Background The risk of death in severe complicated intra-abdominal sepsis (SCIAS) remains high despite decades of surgical and antimicrobial research. New management strategies are required to improve outcomes. The Closed Or Open after Laparotomy (COOL) trial investigates an open-abdomen (OA) approach with active negative pressure peritoneal therapy. This therapy is hypothesized to better manage peritoneal bacterial contamination, drain inflammatory ascites, and reduce the risk of intra-abdominal hypertension leading to improved survival and decreased complications. The total costs and cost-effectiveness of this therapy (as compared with standard fascial closure) are unknown. Methods We propose a parallel cost-utility analysis of this intervention to be conducted alongside the 1-year trial, extrapolating beyond that using decision analysis. Using resource use metrics (e.g., length of stay, re-admissions) from patients at all study sites and microcosting data from patients enrolled in Calgary, Alberta, the mean cost difference between treatment arms will be established from a publicly-funded health care payer perspective. Quality of life will be measured at 6 months and 1 year postoperatively with the Euroqol EQ-5D-5 L and SF-36 surveys. A within-trial analysis will establish cost and utility at 1 year, using a bootstrapping approach to provide confidence intervals around an estimated incremental cost-effectiveness ratio. If neither operative strategy is economically dominant, Markov modeling will be used to extrapolate the cost per quality-adjusted life years gained to 2-, 5-, 10-year, and lifetime horizons. Future costs and benefits will be discounted at 1.5% per annum. A cost-effectiveness acceptability curve will be generated using Monte Carlo simulation. If all trial outcomes are similar, the primary analysis will default to a cost-minimization approach. Subgroup analysis will be carried out for patients with and without septic shock at presentation, and for patients whose initial APACHE II scores are > 20 versus ≤ 20. Discussion In addition to an estimate of the clinical effectiveness of an OA approach for SCIAS, an understanding of its cost effectiveness will be required prior to its adoption in any resource-constrained environment. We will estimate this key parameter for use by clinicians and policymakers. Trial Registration ClinicalTrials.gov, NCT03163095, registered May 22, 2017.
Open Access
Psoriatic Arthritis Screening: A Systematic Review, Meta-Analysis, and Economic Evaluation
(2018-09-13) Iragorri Amaya, Nicolas; Spackman, Eldon; Manns, Braden; Hazlewood, Glen S.
Psoriatic arthritis (PsA) is an autoimmune disease that affects the skin and the musculoskeletal system. It causes joint damage and psoriasis of the skin. Untreated disease is usually related to a delayed diagnosis and has been associated with physical disability and high treatment costs later on. Although expensive biologic therapy has proven to slow disease progression and improve health outcomes, rheumatologists have suggested initiating treatment with less expensive Disease Modifying Anti-Rheumatic Drugs (DMARDs). Identifying early PsA is expected to improve health outcomes through early treatment with DMARDs. It is also expected to reduce the proportion of severe disease and biologic treatment. Given that the prevalence of PsA among psoriasis patients is relatively high, dermatologists are well-positioned to screen for arthritis symptoms with already validated self-administered screening questionnaires for patients with psoriasis. The goal of this thesis is to systematically review the characteristics and accuracy estimates of the validated PsA screening tools (chapter 2). It also seeks to evaluate the cost-effectiveness of implementing a PsA screening program in Canada relative to the current practice where psoriasis patients are not systematically screened (chapter 3). The National Institute of Health Research is currently developing a randomized controlled trial for PsA screening in the United Kingdom that will inform the cost-effectiveness model presented in this thesis.
Open Access
Re-Purposing the Ordering of Routine Laboratory Tests in Hospitalized Medical Patients (RePORT): protocol for a multicenter stepped-wedge cluster randomised trial to evaluate the impact of a multicomponent intervention bundle to reduce laboratory test over-utilization
(2024-07-02) Ambasta, Anshula; Holroyd-Leduc, Jayna M.; Pokharel, Surakshya; Mathura, Pamela; Shih, Andrew W.; Stelfox, Henry T.; Ma, Irene; Harrison, Mark; Manns, Braden; Faris, Peter; Williamson, Tyler; Shukalek, Caley; Santana, Maria; Omodon, Onyebuchi; McCaughey, Deirdre; Kassam, Narmin; Naugler, Chris
Abstract Background Laboratory test overuse in hospitals is a form of healthcare waste that also harms patients. Developing and evaluating interventions to reduce this form of healthcare waste is critical. We detail the protocol for our study which aims to implement and evaluate the impact of an evidence-based, multicomponent intervention bundle on repetitive use of routine laboratory testing in hospitalized medical patients across adult hospitals in the province of British Columbia, Canada. Methods We have designed a stepped-wedge cluster randomized trial to assess the impact of a multicomponent intervention bundle across 16 hospitals in the province of British Columbia in Canada. We will use the Knowledge to Action cycle to guide implementation and the RE-AIM framework to guide evaluation of the intervention bundle. The primary outcome will be the number of routine laboratory tests ordered per patient-day in the intervention versus control periods. Secondary outcome measures will assess implementation fidelity, number of all common laboratory tests used, impact on healthcare costs, and safety outcomes. The study will include patients admitted to adult medical wards (internal medicine or family medicine) and healthcare providers working in these wards within the participating hospitals. After a baseline period of 24 weeks, we will conduct a 16-week pilot at one hospital site. A new cluster (containing approximately 2–3 hospitals) will receive the intervention every 12 weeks. We will evaluate the sustainability of implementation at 24 weeks post implementation of the final cluster. Using intention to treat, we will use generalized linear mixed models for analysis to evaluate the impact of the intervention on outcomes. Discussion The study builds upon a multicomponent intervention bundle that has previously demonstrated effectiveness. The elements of the intervention bundle are easily adaptable to other settings, facilitating future adoption in wider contexts. The study outputs are expected to have a positive impact as they will reduce usage of repetitive laboratory tests and provide empirically supported measures and tools for accomplishing this work. Trial Registration This study was prospectively registered on April 8, 2024, via ClinicalTrials.gov Protocols Registration and Results System (NCT06359587). https://classic.clinicaltrials.gov/ct2/show/NCT06359587?term=NCT06359587&recrs=ab&draw=2&rank=1
Open Access
The Steroids In the Maintenance of remission of Proliferative Lupus nephritis (SIMPL) pilot trial
(Canadian Journal of Kidney Health and Disease, 2014-11-28) Galbraith, Lauren; Manns, Braden; Hemmelgarn, Brenda; Walsh, Michael
Background Patients with proliferative lupus nephritis are at risk of frequent relapses. Whether low- dose prednisone prevents relapses is uncertain. Objectives We undertook a pilot RCT to determine the feasibility of a larger trial. Design Pilot randomized controlled trial. Setting Single center Canadian outpatient nephrology clinic. Patients Participants with systemic lupus erythematosus (SLE) and a history of class III or IV lupus nephritis that achieved at least partial remission and remained on prednisone were eligible. Measurements Feasibility: proportion of eligible patients randomized and adherence to tapering regimen. Clinical: occurrence of renal or major non-renal flare of SLE. Methods We conducted a blinded, two-parallel-group randomized controlled trial of prednisone 7.5 mg/day (continuation) compared to a matching placebo (withdrawal). Results Of nineteen eligible patients screened, 15 (79%) were recruited and randomized; 8 to prednisone continuation and seven to withdrawal. All participants adhered to the tapering protocol to their assigned withdrawal or low-dose maintenance target. Over 36 months, the primary outcome occurred in four (50%) patients in the continuation group (three renal and one major non-renal flare), compared with one patient (14%) in the withdrawal group (one renal flare). Three participants (38%) in the continuation group had minor flares, while no patients in the withdrawal group did. Limitations This pilot RCT was small and not designed to assess the efficacy or safety of maintenance with low-dose prednisone. Conclusions The high proportion of eligible patients recruited, and success of protocol adherence suggest a large trial of prednisone maintenance therapy compared to withdrawal is feasible. Trial registration Current Controlled Trials ISRCTN31327267.