[Show abstract][Hide abstract] ABSTRACT: Individuals with chronic diseases may have difficulty optimizing their health and getting the care they need due to a combination of patient, provider, and health system level barriers. Patient navigator programs, in which trained personnel assess and assist patients in overcoming barriers to care, may improve care and outcomes for patients with chronic disease by providing an alternative approach to conventional information and support resources.
This systematic review will evaluate the evidence for patient navigator programs, compared to usual care, in patients with chronic disease. We will include RCTs, cluster RCTs, and quasi-randomized RCTs that study the effects of patient navigator programs on clinical outcomes, patient experience, and markers of adherence to care. Studies will be identified by searching MEDLINE, Embase, the Cochrane Central Register of Controlled Trials (CENTRAL), CINAHL, PsycINFO, Social Work Abstracts, and the references of included studies. Two authors will screen titles and abstracts independently. Full texts will be reviewed for relevance and data extraction will be done independently by two authors. Studies will be included if they assess patients of any age with one or more chronic diseases. Outcomes will be categorized into groups characterized by their proximity to mechanism of action of the intervention: patient-level outcomes, intermediate outcomes, and process outcomes. Descriptive data about the elements of the patient navigator intervention will also be collected for potential subgroup analyses. Risk of bias will be assessed using the Effective Practice and Organisation of Care Group (EPOC) risk of bias tool. Data will be analyzed using random effects meta-analysis (relative risk for dichotomous data and mean difference for continuous data), if appropriate.
A comprehensive review of patient navigator programs, including a summary of the elements of programs that are associated with a successful intervention, does not yet exist. This systematic review will synthesize the evidence of the effect of patient navigator interventions on clinical and patient-oriented outcomes in populations across a comprehensive set of chronic diseases.
PROSPERO CRD42013005857 .
[Show abstract][Hide abstract] ABSTRACT: The outcomes of acute kidney injury (AKI) are well appreciated. However, valid indicators of high quality processes of care for AKI after major surgery are lacking.
To identify indicators of high quality processes of care related to AKI prevention, identification, and management after major surgery.
A three stage modified Delphi process.
The study was conducted in Alberta, Canada using an online format.
A panel of care providers from surgery, critical care, and nephrology.
The degree of validity of candidate indicators were rated by panelists on a 7-point Likert scale that ranged from "strongly disagree" to "strongly agree".
A focused literature review was performed to identify candidate indicators. A modified Delphi process, with three rounds, was used to obtain expert consensus on the validity of potential process of care quality indicators.
Thirty-three physicians participated (6 from surgery, 10 from critical care, and 17 from nephrology). A list of 58 potential process of care quality indicators for AKI after surgery was generated including 28 indicators from the initial literature review and 30 indicators suggested by panelists. Following the third round of questioning, 40 process of care indicators were identified with a high level of agreement for face validity; 16 of these reached high consensus among all panelists.
The consensus of panelists from Alberta, Canada may not be generalizable to other settings. The modified Delphi process did not focus on the feasibility of measuring these process indicators.
These indicators can be used to measure and improve the quality of care for AKI after major surgery.
[Show abstract][Hide abstract] ABSTRACT: Knowledge generation through randomized controlled trials (RCTs) is critical to advance the medical evidence base, inform decision-making, and improve care and outcomes. Unfortunately, nephrology has typically lagged behind other medical specialties in this regard. The establishment of formal clinical trial networks can facilitate the successful conduct of RCTs and has significantly increased the number of RCTs performed worldwide in other medical specialties. No such formal network of nephrology trialists exists in Canada. On April 24, 2014, the Canadian Kidney Knowledge Translation and Generation Network (CANN-NET) Clinical Trials Committee held a stakeholder engagement meeting to address this gap and improve the nephrology clinical trial landscape in Canada. The meeting was held in Vancouver in association with the 2014 Canadian Society of Nephrology Annual General Meeting and was co-sponsored by the Kidney Foundation of Canada and CANN-NET. Attendees included nephrologists from university- and non-university-affiliated nephrology practices, administrators, and representatives from the Kidney Foundation of Canada. Through structured presentations and facilitated group discussions, the group explored the extent to which nephrology trials are currently happening in Canada, barriers to leading or participating in larger investigator-initiated trials, and strategies to improve clinical trial output in nephrology in Canada. The themes and action items arising from this meeting are discussed.
Electronic supplementary material
The online version of this article (doi:10.1186/s40697-015-0080-7) contains supplementary material, which is available to authorized users.
[Show abstract][Hide abstract] ABSTRACT: Aims:
People with diabetes and poor glycaemic control are at higher risk of diabetes-related complications and incur higher healthcare costs. An understanding of the sociodemographic and clinical characteristics associated with poor glycaemic control is needed to overcome the barriers to achieving care goals in this population.
We used linked administrative and laboratory data to create a provincial cohort of adults with prevalent diabetes, and a measure of HbA1c that occurred at least 1 year following the date of diagnosis. The primary outcome was poor glycaemic control, defined as at least two consecutive HbA1c measurements ≥ 86 mmol/mol (10%), not including the index measurement, spanning a minimum of 90 days. We used multivariable Cox proportional hazards models to evaluate the association between baseline sociodemographic and clinical factors and poor glycaemic control.
In this population-based cohort of 169 890 people, younger age was significantly associated with sustained poor glycaemic control, with a hazard ratio (HR) of 3.08, 95% CI (2.79-3.39) for age 18-39 years compared with age ≥ 75 years. Longer duration of diabetes, First Nations status, lower neighbourhood income quintile, history of substance abuse, mood disorder, cardiovascular disease, albuminuria and high LDL cholesterol were also associated with poor glycaemic control.
Although our results may be limited by the observational nature of the study, the large geographically defined sample size, longitudinal design and robust definition of poor glycaemic control are important strengths. These findings demonstrate the complexity associated with poor glycaemic control and indicate a need for tailored interventions. This article is protected by copyright. All rights reserved.
Diabetic Medicine 11/2015; DOI:10.1111/dme.13023 · 3.12 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Purpose of review
There is growing acknowledgement that engaging patients to identify their research priorities is important. Using a case study of patients on or nearing dialysis, we sought to assess the extent to which recently completed and ongoing clinical research was consistent with priorities identified by patients, caregivers, and clinicians.
Sources of information
Over a 4-year sampling frame (January 2010 to December 2013), we systematically searched the medical literature (top 5 nephrology and top 10 general medicine journals accessed through MEDLINE via Ovid), international randomized controlled trial (RCT) registries, and national government and kidney research funding organizations (Canada, U.S., Australia, and U.K.) for published clinical studies, registered RCTs, and funded clinical studies, respectively. Published clinical studies, registered RCTs, and funded clinical studies were categorized as to whether or not they were consistent with the top 10 research priorities identified by patients, their caregivers, and clinicians in a recent comprehensive research priority setting exercise.
The search yielded 4293 published articles, 688 RCTs, and 70 funded studies, of which 1116 articles, 315 RCTs, and 70 funded studies were eligible for inclusion. Overall 194 published studies (17.4 %), 71 RCTs (22.5 %), and 15 funded studies (21.4 %) included topics consistent with the top 10 research priorities identified by patients. Four of the top 10 research priorities, including strategies to improve the management of itching, increase access to kidney transplantation, assess the psychosocial impact of kidney failure, and determine the effects of dietary restriction received virtually no attention.
The top 10 priorities we used to categorize included studies were identified by Canadian patients, caregivers, and clinicians. The top research priorities may vary across different countries. The proportion of published studies that are consistent with the top 10 priorities could be different in nephrology journals with lower impact factors. Studies related to kidney transplantation and the psychosocial impact of kidney failure may have been published in journals not included in our search strategy.
The majority of recently completed or ongoing clinical studies in patients on or nearing dialysis do not address the top research priorities of patients, raising concerns that current clinical research may not be meeting the needs of the ultimate consumer, in this case, patients on or nearing dialysis. Greater involvement of patients in research is required to bridge the gap between research and patients’ needs.
[Show abstract][Hide abstract] ABSTRACT: Background:
Using a community-based cohort we sought to investigate the association between change in estimated glomerular filtration rate (eGFR) and risk of incident cardiovascular disease including congestive heart failure (CHF), acute myocardial infarction (AMI), and stroke.
We identified 479,126 adults without a history of cardiovascular disease who had at least 3 outpatient eGFR measurements over a 4year period in Alberta, Canada. Change in eGFR was estimated as the absolute annual rate of change (categorized as ≤-5, -4, -3, -2, -1, 0, 1, 2, 3, 4, and ≥5mL/min/1.73m(2)/year). In a sensitivity analysis we also estimated change as the annual percentage change (categorized as ≤-7, -6 to -5, -4 to -3, -2 to -1, 0, 1 to 2, 3 to 4, 5 to 6, and ≥7%/year). The adjusted risk of incident CHF, AMI, and stroke associated with each category of change in eGFR was estimated, using no change in eGFR as the reference, RESULTS: There were 2622 (0.6%) CHF, 3463 (0.7%) AMI, and 2768 (0.6%) stroke events over a median follow-up of 2.5years. Compared to participants with stable eGFR, those with the greatest decline (≤-5mL/min/1.73m(2)/year) had more than a two-fold increased risk of CHF (HR 2.57; 95% CI: 2.28 to 2.89). Risk for AMI and stroke was increased by 31% and 29%, respectively. After adjusting for the last eGFR at the end of the accrual period, the observed association remained significantly higher for CHF but diminished for AMI and stroke. A similar pattern was observed when change in eGFR was quantified as annual percentage change.
In this large community-based cohort, we observed that a declining eGFR was associated with an increased risk of CHF, AMI, and stroke. However, when the risk of CVD events was adjusted for the last eGFR measurement, decline in eGFR per se was no longer associated with increased risk of AMI or stroke, and the association with CHF remained significant but was attenuated. These results demonstrate the importance of monitoring change in eGFR over time to improve cardiovascular risk prognostication.
International Journal of Cardiology 09/2015; 202. DOI:10.1016/j.ijcard.2015.09.090 · 4.04 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Chronic kidney disease is a significant contributor to mortality and morbidity worldwide, and the number of people who require dialysis or transplantation continues to increase. People on dialysis are 15 times more likely to die than the general population. Dialysis is also costly, intrusive, and time-consuming and imposes an enormous burden on patients and their families. This escalating problem has spurred a proliferation of trials in dialysis, yet health and quality of life remain poor. The reasons for this are complex and varied but are attributable in part to problems in the design and reporting of studies, particularly outcome selection. Problems related to outcomes include use of unvalidated surrogates, outcomes of little or no relevance to patients, highly variable outcome selection limiting comparability across studies, and bias in reporting outcomes. The aim of the Standardised Outcomes in Nephrology-Haemodialysis (SONG-HD) study is to establish a core outcome set for haemodialysis trials, to improve the quality of reporting, and the relevance of trials conducted in people on haemodialysis.
SONG-HD is a five-phase project that includes the following: a systematic review to identify outcomes that have been reported in haemodialysis systematic reviews and trials; nominal group technique with patients and caregivers to identify, rank, and describe reasons for their choices; qualitative stakeholder interviews with patients, caregivers, clinicians, researchers, and policy makers to elicit individual values and perspectives on outcomes for haemodialysis trials; a three-round Delphi survey with stakeholder groups to distil and generate a prioritised list of core outcomes; and a consensus workshop to establish a core outcome set for haemodialysis trials.
Establishing a core outcome set to be consistently measured and reported in haemodialysis trials will improve the integrity, transparency, usability, and contribution of research relevant to patients requiring haemodialysis; ensure that outcomes of relevance to all stakeholders are consistently reported across trials; and mitigate against outcome reporting bias. Ultimately, patients will be more protected from potential harm, patients and clinicians will be better able to make informed decisions about treatment, and researchers and policy makers will be more able to maximise the value of research to the public.
[Show abstract][Hide abstract] ABSTRACT: Chronic kidney disease (CKD) is associated with poor outcomes, perhaps due to a high burden of comorbidity. Most studies of CKD populations focus on concordant comorbidities, which cause CKD (such as hypertension and diabetes) or often accompany CKD (such as heart failure or coronary disease). Less is known about the burden of mental health conditions and discordant conditions (those not concordant but still clinically relevant, like dementia or cancer). Here we did a retrospective population-based cohort study of 530,771 adults with CKD residing in Alberta, Canada between 2003 and 2011. Validated algorithms were applied to data from the provincial health ministry to assess the presence/absence of 29 chronic comorbidities. Linkage between comorbidity burden and adverse clinical outcomes (mortality, hospitalization or myocardial infarction) was examined over median follow-up of 48 months. Comorbidities were classified into three categories: concordant, mental health/chronic pain, and discordant. The median number of comorbidities was 1 (range 0-15) but a substantial proportion of participants had 3 and more, or 5 and more comorbidities (25 and 7%, respectively). Concordant comorbidities were associated with excess risk of hospitalization, but so were discordant comorbidities and mental health conditions. Thus, discordant comorbidities and mental health conditions as well as concordant comorbidities are important independent drivers of the adverse outcomes associated with CKD.Kidney International advance online publication, 29 July 2015; doi:10.1038/ki.2015.228.
Kidney International 07/2015; 88(4). DOI:10.1038/ki.2015.228 · 8.56 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: BACKGROUND AND OBJECTIVES:
Mineralocorticoid receptor antagonism reduces morbidity and mortality in patients with heart failure, but the safety of these drugs in patients receiving dialysis is unclear. This study evaluated whether hyperkalemia and/or hypotension limited the use of eplerenone, a selective mineralocorticoid receptor antagonist, in hemodialysis patients.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS:
This was a randomized controlled trial of prevalent patients receiving hemodialysis at five Canadian centers. Participants were randomly allocated to 13 weeks of eplerenone titrated to 50 mg daily (n=77) or a matching placebo (n=77). The primary outcome was permanent discontinuation of the drug because of hyperkalemia or hypotension. Secondary outcomes included hyperkalemia, hypotension, and cardiovascular events.
Seventy-five eplerenone-treated patients and 71 placebo-treated patients were included in the per protocol population. The primary outcome occurred in three patients (4.0%) in the eplerenone group and two (2.8%) in the placebo group, for an absolute risk difference of 1.2 percentage points (95% confidence interval, -4.7 to 7.1 percentage points). Eplerenone was interpreted as noninferior to placebo with respect to the primary outcome (i.e., a discontinuation rate for these reasons >10% was excluded). In the eplerenone group, nine patients (11.7%) developed hyperkalemia (potassium level >6.5 mEq/L), compared with two patients (2.6%) in the placebo group (relative risk, 4.5; 95% confidence interval, 1.0 to 20.2). There was no significant effect on predialysis or postdialysis BP.
Eplerenone increased the risk of hyperkalemia but did not result in an excess need to permanently discontinue the drug. Further trials are required to determine whether mineralocorticoid receptor antagonism improves cardiovascular outcomes in patients receiving long-term dialysis.
Clinical Journal of the American Society of Nephrology 07/2015; 10(9). DOI:10.2215/CJN.12371214 · 4.61 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Electronic personal health records (ePHRs) provide patients with access to their personal health information, aiming to inform them about their health, enhance self-management, and improve outcomes. Although they have been associated with improved health outcomes in several chronic diseases, the potential impact of ePHR use in chronic kidney disease (CKD) is unknown.
We sought to understand perceptions of CKD patients about ePHRs, and describe characteristics associated with their expressed intent to use an ePHR.
Self-administered paper based survey.
The study was conducted in Calgary, Alberta, Canada at a multidisciplinary CKD clinic from November 2013 to January 2014.
Patients with non-dialysis-dependent CKD.
Demographics, perceived benefits, and drawbacks of ePHRs were obtained. A univariate analysis was used to assess for an association with the expressed intention to use an ePHR.
A patient survey was used to determine perceptions of ePHRs, and to identify factors that were associated with intention to use an ePHR.
Overall 63 patients with CKD (76.2 % male, 55.6 % ≥65 years old) completed the survey. The majority (69.8 %) expressed their intent to use an ePHR. CKD patients over the age of 65 were less likely to intend to use an ePHR as compared to those aged <65 years (OR 0.22, 95 % CI: [0.06, 0.78]). Those with post-secondary education (OR 3.31, 95 % CI: [1.06, 10.41]) and Internet access (OR 5.70, 95 % CI: [1.64, 19.81]) were more likely to express their intent to use an ePHR. Perceived benefits of ePHR use included greater involvement in their own care (50.0 % indicated this), better access to lab results (75.8 %), and access to health information (56.5 %). Although 41.9 % reported concerns about privacy of health information, there was no association between these concerns and the intent to use an ePHR.
Our results are limited by small study size and single centre location.
We found that patients with CKD expressed their intention to use ePHRs, and perceive benefits such as personal involvement in their health care and better access to lab results. Studies of CKD patients using ePHRs are needed to determine whether ePHR use improves patient outcomes.
[Show abstract][Hide abstract] ABSTRACT: Multimorbidity is common and associated with poor clinical outcomes and high health care costs. Administrative data are a promising tool for studying the epidemiology of multimorbidity. Our goal was to derive and apply a new scheme for using administrative data to identify the presence of chronic conditions and multimorbidity.
We identified validated algorithms that use ICD-9 CM/ICD-10 data to ascertain the presence or absence of 40 morbidities. Algorithms with both positive predictive value and sensitivity ≥70% were graded as "high validity"; those with positive predictive value ≥70% and sensitivity <70% were graded as "moderate validity". To show proof of concept, we applied identified algorithms with high to moderate validity to inpatient and outpatient claims and utilization data from 574,409 people residing in Edmonton, Canada during the 2008/2009 fiscal year.
Of the 40 morbidities, we identified 30 that could be identified with high to moderate validity. Approximately one quarter of participants had identified multimorbidity (2 or more conditions), one quarter had a single identified morbidity and the remaining participants were not identified as having any of the 30 morbidities.
We identified a panel of 30 chronic conditions that can be identified from administrative data using validated algorithms, facilitating the study and surveillance of multimorbidity. We encourage other groups to use this scheme, to facilitate comparisons between settings and jurisdictions.
BMC Medical Informatics and Decision Making 04/2015; 15(1):31. DOI:10.1186/s12911-015-0155-5 · 1.83 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: People with kidney failure are often deficient in zinc and selenium, but little is known about the optimal way to correct such deficiency.
We did a double-blind randomized trial evaluating the effects of zinc (Zn), selenium (Se) and vitamin E added to the standard oral renal vitamin supplement (B and C vitamins) among hemodialysis patients in Alberta, Canada. We evaluated the effect of two daily doses of the new supplement (medium dose: 50 mg Zn, 75 mcg Se, 250 IU vitamin E; low dose: 25 mg Zn, 50 mcg Se, 250 IU vitamin E) compared to the standard supplement on blood concentrations of Se and Zn at 90 days (primary outcome) and 180 days (secondary outcome) as well as safety outcomes.
We enrolled 150 participants. The proportion of participants with low zinc status (blood level <815 ug/L) did not differ between the control group and the two intervention groups at 90 days (control 23.9% vs combined intervention groups 23.9%, P > 0.99) or 180 days (18.6% vs 28.2%, P = 0.24). The proportion with low selenium status (blood level <121 ug/L) was similar for controls and the combined intervention groups at 90 days (32.6 vs 19.6%, P = 0.09) and 180 days (34.9% vs 23.5%, P = 0.17). There were no significant differences in the risk of adverse events between the groups.
Supplementation with low or medium doses of zinc and selenium did not correct low zinc or selenium status in hemodialysis patients. Future studies should consider higher doses of zinc (≥75 mg/d) and selenium (≥100 mcg/d) with the standard supplement.
Registered with ClinicalTrials.gov ( NCT01473914 ).
[Show abstract][Hide abstract] ABSTRACT: The pressure for health care systems to provide more resource intensive health care and newer, more costly, therapies is significant, despite limited health care budgets. As such, demonstration that a new therapy is effective is no longer sufficient to ensure that it is funded within publicly funded health care systems. The impact of a therapy on health care costs is also an important consideration for decision-makers who must allocate scarce resources. The clinical benefits and costs of a new therapy can be estimated simultaneously using economic evaluation, the strengths and limitations of which are discussed herein. In addition, this chapter includes discussion of the important economic outcomes that can be collected within a clinical trial (alongside the clinical outcome data) enabling consideration of the impact of the therapy on overall resource use, thus enabling performance of an economic evaluation, if the therapy is shown to be effective.
[Show abstract][Hide abstract] ABSTRACT: There is a significant gap between what is known and what is implemented by key stakeholders in practice (the evidence to practice gap). The primary purpose of knowledge translation is to address this gap, bridging evidence to clinical practice. The knowledge to action cycle is one framework for knowledge translation that integrates policy-makers throughout the research cycle. The knowledge to action cycle begins with the identification of a problem (usually a gap in care provision). After identification of the problem, knowledge creation is undertaken, depicted at the center of the cycle as a funnel. Knowledge inquiry is at the wide end of the funnel, and moving down the funnel, the primary data is synthesized into knowledge products in the form of educational materials, guidelines, decision aids, or clinical pathways. The remaining components of the knowledge to action cycle refer to the action of applying the knowledge that has been created. This includes adapting knowledge to local context, assessing barriers to knowledge use, selecting, tailoring implementing interventions, monitoring knowledge use, evaluating outcomes, and sustaining knowledge use. Each of these steps is connected by bidirectional arrows and ideally involves healthcare decision-makers and key stakeholders at each transition.