People with HIV are living longer and their care has shifted towards the prevention and management of comorbidities. However, little is known about who is providing their care. Our objective was to characterize the provision of HIV care in Ontario by physician specialty.
We conducted a retrospective population-based observational study using linked administrative databases in Ontario, Canada, a single payer health care system. All Ontarians with HIV were identified using a validated case ascertainment algorithm. We examined office-based health care visits for this cohort between April 1, 2009 and March 31, 2012. Physician characteristics were compared between specialty groups. We stratified the frequency and distribution of physician care into three categories: (a) care by physician specialty (family physicians, internal medicine specialists, infectious disease specialists, and other specialists), (b) care based on physician caseload (low, medium or high categorized as ≤5, 6-49 or ≥50 HIV patients per physician), and (c) care that is related to HIV versus unrelated to HIV.
Family physicians were older, graduated earlier, were more often female, and were the only group practicing in rural settings. Unlike other specialists, most family physicians (76.8%) had low-volume caseloads. There were 406,411 outpatient visits made by individuals with HIV; one-third were for HIV care. Family physicians provided the majority of care (53.6% of all visits and 53.9% of HIV visits). Internal medicine specialists provided 4.9% of all visits and 9.6% of HIV visits. Infectious disease specialists provided 12.5% of all visits and 32.7% of HIV visits. Other specialties provided 29.0% of visits; most of these (33.0%) were to psychiatrists.
The distribution of visits to physicians caring for HIV patients reveals different patterns of health care delivery by specialty and HIV caseload. Further research should delineate how specialties share care for this population and how different patterns relate to quality of care.
Human immunodeficiency syndrome; Primary health care; Chronic disease; Comorbidity; Multimorbidity; Health services delivery
Recent publications have called for substantial improvements in the design, conduct, analysis and reporting of prediction models. Publication of study protocols, with prespecification of key aspects of the analysis plan, can help to improve transparency, increase quality and protect against increased type I error. Valid population-based risk algorithms are essential for population health planning and policy decision-making. The purpose of this study is to develop, evaluate and apply cardiovascular disease (CVD) risk algorithms for the population setting.
Methods and analysis
The Ontario sample of the Canadian Community Health Survey (2001, 2003, 2005; 77 251 respondents) will be used to assess risk factors focusing on health behaviours (physical activity, diet, smoking and alcohol use). Incident CVD outcomes will be assessed through linkage to administrative healthcare databases (619 886 person-years of follow-up until 31 December 2011). Sociodemographic factors (age, sex, immigrant status, education) and mediating factors such as presence of diabetes and hypertension will be included as predictors. Algorithms will be developed using competing risks survival analysis. The analysis plan adheres to published recommendations for the development of valid prediction models to limit the risk of overfitting and improve the quality of predictions. Key considerations are fully prespecifying the predictor variables; appropriate handling of missing data; use of flexible functions for continuous predictors; and avoiding data-driven variable selection procedures. The 2007 and 2009 surveys (approximately 50 000 respondents) will be used for validation. Calibration will be assessed overall and in predefined subgroups of importance to clinicians and policymakers.
Ethics and dissemination
This study has been approved by the Ottawa Health Science Network Research Ethics Board. The findings will be disseminated through professional and scientific conferences, and in peer-reviewed journals. The algorithm will be accessible electronically for population and individual uses.
Trial registration number
PUBLIC HEALTH; STATISTICS & RESEARCH METHODS; EPIDEMIOLOGY
Clinical decision rules (CDRs) can be an effective tool for knowledge translation in emergency medicine, but their implementation is often a challenge. This study examined whether the Theory of Planned Behaviour (TPB) could help explain the inconsistent results between the successful Canadian C-Spine Rule (CCR) implementation study and unsuccessful Canadian CT Head Rule (CCHR) implementation study. Both rules are aimed at improving the accuracy and efficiency of emergency department radiography use in clinical contexts that exhibit enormous inefficiency at the present time. The rules were prospectively derived and validated using the same methodology demonstrating high sensitivity and reliability. The rules subsequently underwent parallel implementations at 12 Canadian hospitals, yet only the CCR was observed to significantly reduce radiography ordering rates, while the CCHR failed to have any significant impact at all. The drastically different results are unlikely to be the result of differences in implementation strategies or the decision rules.
Physicians at the 12 participating Canadian hospitals were randomized to CCR or CCHR TPB surveys that were administered during the baseline phases of the implementation studies, before any intervention had taken place. The collected baseline survey data were linked to concurrent baseline physician and patient-specific imaging data, and subsequently analyzed using mixed effects linear and logistic models.
A total of 223 of the 378 eligible physicians randomized to a TPB survey completed their assigned baseline survey (CCR: 122 of 181; CCHR: 101 of 197). Attitudes were significantly associated with intention in both settings (CCR: ß = 0.40; CCHR: ß = 0.30), as were subjective norms (CCR: ß = 0.26; CCHR: ß = 0.73). Intention was significantly associated with actual image ordering for CCR (OR = 1.79), but not CCHR.
The TPB can be used to better understand processes underlying use of CDRs. TPB constructs were significantly associated with intention to perform both imaging behaviours, but intention was only associated with actual behaviour for CCR, suggesting that constructs outside of the TPB framework may need to be considered when seeking to understand use of CDRs.
Electronic supplementary material
The online version of this article (doi:10.1186/s13012-014-0088-x) contains supplementary material, which is available to authorized users.
Clinical decision rules; Canadian C-Spine Rule; Canadian CT-Head Rule; Theory of planned behaviour; Emergency physicians; Implementation study
A shortage of transplantable organs is a global problem. There are two types of organ donation: living and deceased. Deceased organ donation can occur following neurological determination of death (NDD) or cardiocirculatory death. Donation after cardiocirculatory death (DCD) accounts for the largest increments in deceased organ donation worldwide. Variations in the use of DCD exist, however, within Canada and worldwide. Reasons for these discrepancies are largely unknown. The purpose of this study is to develop, implement, and evaluate a theory-based knowledge translation intervention to provide practical guidance about how to increase the numbers of DCD organ donors without reducing the numbers of standard NDD donors.
We will use a mixed method three-step approach. In step one, we will conduct semi-structured interviews, informed by the Theoretical Domains Framework, to identify and describe stakeholders’ beliefs and attitudes about DCD and their perceptions of the multi-level factors that influence DCD. We will identify: determinants of the evidence-practice gap; specific behavioural changes and/or process changes needed to increase DCD; specific group(s) of clinicians or organizations (e.g., provincial donor organizations) in need of behaviour change; and specific targets for interventions. In step two, using the principles of intervention mapping, we will develop a theory-based knowledge translation intervention that encompasses behavior change techniques to overcome the identified barriers and enhance the enablers to DCD. In step three, we will roll out the intervention in hospitals across the 10 Canadian provinces and evaluate its effectiveness using a multiple interrupted time series design.
We will adopt a behavioural approach to define and test novel, theory-based, and ethically-acceptable knowledge translation strategies to increase the numbers of available DCD organ donors in Canada. If successful, this study will ultimately lead to more transplantations, reducing patient morbidity and mortality at a population-level.
An interrupted time series design is a powerful quasi-experimental approach for evaluating effects of interventions introduced at a specific point in time. To utilize the strength of this design, a modification to standard regression analysis, such as segmented regression, is required. In segmented regression analysis, the change in intercept and/or slope from pre- to post-intervention is estimated and used to test causal hypotheses about the intervention. We illustrate segmented regression using data from a previously published study that evaluated the effectiveness of a collaborative intervention to improve quality in pre-hospital ambulance care for acute myocardial infarction (AMI) and stroke. In the original analysis, a standard regression model was used with time as a continuous variable. We contrast the results from this standard regression analysis with those from segmented regression analysis. We discuss the limitations of the former and advantages of the latter, as well as the challenges of using segmented regression in analysing complex quality improvement interventions.
Based on the estimated change in intercept and slope from pre- to post-intervention using segmented regression, we found insufficient evidence of a statistically significant effect on quality of care for stroke, although potential clinically important effects for AMI cannot be ruled out.
Segmented regression analysis is the recommended approach for analysing data from an interrupted time series study. Several modifications to the basic segmented regression analysis approach are available to deal with challenges arising in the evaluation of complex quality improvement interventions.
Interrupted time series design; Segmented regression analysis; Quality improvement collaborative
Women are disproportionately affected by cardiovascular disease, often experiencing poorer outcomes following a cardiovascular event. Evidence points to inequities in processes of care as a potential contributing factor. This study sought to determine whether any sex differences exist in adherence to process of care guidelines for cardiovascular disease within primary care practices in Ontario, Canada.
This is a secondary analysis of pooled cross-sectional baseline data collected through a larger quality improvement initiative known as the Improved Delivery of Cardiovascular Care (IDOCC). Chart abstraction was performed for 4,931 patients from 84 primary care practices in Eastern Ontario who had, or were at high risk of, cardiovascular disease. Measures examining adherence to guidelines associated with nine areas of cardiovascular care (coronary artery disease, peripheral vascular disease (PVD), stroke/transient ischemic attack, chronic kidney disease, diabetes, dyslipidemia, hypertension, smoking cessation, and weight management) were collected. Multivariable logistic regression analysis was performed to evaluate sex differences, adjusting for age, physician remuneration, and rurality.
Women were significantly less likely to have their lipid profiles taken (OR = 1.17, 95% CI 1.03-1.33), be prescribed lipid lowering medication for dyslipidemia (OR = 1.54, 95% CI 1.20-1.97), and to be prescribed ASA following stroke (OR = 1.56, 95% CI 1.39-1.75). Women with PVD were significantly less likely to be prescribed ACE inhibitors and/or angiotensin receptor blockers (OR = 1.74, 95% CI 1.25-2.41) and lipid lowering medications (OR = 1.95, 95% CI 1.46-2.62) or ASA (OR = 1.59, 95% CI 1.43-1.78). However, women were more likely to have two blood pressure measurements taken and to be referred to a dietician or weight loss program. Male patients with diabetes were less likely to be prescribed glycemic control medication (OR = 0.84, 95% CI 0.74-0.86).
Sex disparities exist in the quality of cardiovascular care in Canadian primary care practices, which tend to favour men. Women with PVD have a particularly high risk of not receiving appropriate medications. Our findings indicate that improvements in care delivery should be made to address these issues, particularly with regard to the prescribing of recommended medications for women, and preventive measures for men.
Sex equity; Primary care; Cardiovascular disease; Guideline adherence
Infant feeding categories, often referred to as breastfeeding definitions, form the basis to describe infant feeding patterns; especially, breastfeeding duration and degree of breastfeeding exclusivity. Researchers use a variety of algorithms and no validated tool exists to measure feeding patterns for research purposes. The goal of this research project was to develop and test a tool to measure patterns of infant feeding for breastfeeding and lactation research.
We used a literature review, survey methods, and statistical analysis to develop and test this health measurement tool. The work was completed in three phases: 1) development of the tool; 2) assessment of content validity with a panel of experts; and 3) testing for inter-rater reliability by comparing the conclusions of 2 independent research assistants (RAs) and by comparing mothers’ feeding diaries with the RAs’ findings. For the third phase, an a priori analysis determined we needed to recruit 75 participants. Inclusion criteria were women who had given birth to a single healthy newborn, planned to breastfeed and were able to breastfeed freely, were able to read and write in English or French, were willing and able to maintain a weekly feeding diary for 6 weeks and to answer 6 English telephone questionnaires (twice within 24 hrs x 3 times over 6 months. To measure inter-rater reliability, we used intraclass correlation coefficient.
The final tool, The FeedCat Tool, contains two parts: 1) questions asked to determine what and how the baby was fed and 2) a chart to indicate the feeding category for each time point and recall period. We recruited 75 breastfeeding mothers to measure inter-rater reliability. Inter-rater reliability for classification of feeding categories by the two RAs and for agreement between the RAs’ findings at 1 month and mothers’ diaries at 4 weeks indicated excellent agreement.
We produced a feeding categories tool that can be used by researchers to describe the type, amount, and mode of feeding, and we tested the tool for content validity and reliability. Researchers should consider The FeedCat Tool for lactation and research projects requiring data about infant feeding patterns.
To evaluate feasibility and potential effectiveness of a patient decision aid (PtDA) for patients and a preference report for surgeons to reduce wait times and improve decision quality in patients with osteoarthritis considering total knee replacement.
A prospective two-arm pilot randomized controlled trial. Patients with osteoarthritis were eligible if they understood English and were referred for surgical consultation about an initial total knee arthroplasty at a Canadian orthopaedic joint assessment clinic. Patients were randomized to the PtDA intervention or usual education. The intervention was an osteoarthritis PtDA for patients and a one-page preference report summarizing patients’ clinical and decisional data for their surgeon. The main feasibility outcomes were rates of recruitment and questionnaire completion; the preliminary effectiveness outcomes were wait times and decision quality.
Of 180 patients eligible for surgical consultation, 142 (79%) were recruited and randomized to the PtDA intervention (n = 71) or usual education (n = 71). Data collection yielded a 93% questionnaire completion rate with less than 1% missing items. After one year, 13% of patients remained on the surgical wait list. The median time from referral to being off the wait list (censored using survival analysis techniques) was 33.4 weeks for the PtDA group (n = 69, 95% CI: 26.0, 41.4) and 33.0 weeks for usual education (n = 71, 95% CI: 26.1, 39.9). Patients exposed to the PtDA had higher decision quality based on knowledge (71% versus 47%; p < 0.0001) and quality decision being an informed choice that is consistent with their values for option outcomes (56.4% versus 25.0%; p < 0.001).
Recruitment of patients with osteoarthritis considering surgery and data collection were feasible. As some patients remained on the surgical waiting list after one year, follow-up should be extended to two years. Patients exposed to the PtDA achieved higher decision quality compared to those receiving usual education but there was no difference in wait for surgery.
Patient decision aids; Patient preferences; Osteoarthritis; Joint arthroplasty; Wait times; Decision quality
As people diagnosed with HIV and receiving combination antiretroviral therapy are now living longer, they are likely to acquire chronic conditions related to normal ageing and the effects of HIV and its treatment. Comordidities for people with HIV have not previously been described from a representative population perspective.
We used linked health administrative data from Ontario, Canada. We applied a validated algorithm to identify people with HIV among all residents aged 18 years or older between April 1, 1992 and March 31, 2009. We randomly selected 5 Ontario adults who were not identified with HIV for each person with HIV for comparison. Previously validated case definitions were used to identify persons with mental health disorders and any of the following physical chronic diseases: diabetes, congestive heart failure, acute myocardial infarction, stroke, hypertension, asthma, chronic obstructive lung disease, peripheral vascular disease and end-stage renal failure. We examined multimorbidity prevalence as the presence of at least two physical chronic conditions, or as combined physical-mental health multimorbidity. Direct age-sex standardized rates were calculated for both cohorts for comparison.
34.4% (95% confidence interval (CI) 33.6% to 35.2%) of people with HIV had at least one other physical condition. Prevalence was especially high for mental health conditions (38.6%), hypertension (14.9%) and asthma (12.7%). After accounting for age and sex differences, people with HIV had significantly higher prevalence of all chronic conditions except myocardial infarction and hypertension, as well as substantially higher multimorbidity (prevalence ratio 1.30, 95% CI 1.18 to 1.44) and combined physical-mental health multimorbidity (1.79, 95% CI 1.65 to 1.94). Prevalence of multimorbidity among people with HIV increased with age. The difference in prevalence of multimorbidity between the two cohorts was more pronounced among women.
People living with HIV in Ontario, especially women, had higher prevalence of comorbidity and multimorbidity than the general population. Quantifying this morbidity at the population level can help inform healthcare delivery requirements for this complex population.
Human immunodeficiency syndrome; Primary health care; Chronic disease; Comorbidity; Multimorbidity
Cluster randomized trials (CRTs) present unique ethical challenges. In the absence of a uniform standard for their ethical design and conduct, problems such as variability in procedures and requirements by different research ethics committees will persist. We aimed to assess the need for ethics guidelines for CRTs among research ethics chairs internationally, investigate variability in procedures for research ethics review of CRTs within and among countries, and elicit research ethics chairs’ perspectives on specific ethical issues in CRTs, including the identification of research subjects. The proper identification of research subjects is a necessary requirement in the research ethics review process, to help ensure, on the one hand, that subjects are protected from harm and exploitation, and on the other, that reviews of CRTs are completed efficiently.
A web-based survey with closed- and open-ended questions was administered to research ethics chairs in Canada, the United States, and the United Kingdom. The survey presented three scenarios of CRTs involving cluster-level, professional-level, and individual-level interventions. For each scenario, a series of questions was posed with respect to the type of review required (full, expedited, or no review) and the identification of research subjects at cluster and individual levels.
A total of 189 (35%) of 542 chairs responded. Overall, 144 (84%, 95% CI 79 to 90%) agreed or strongly agreed that there is a need for ethics guidelines for CRTs and 158 (92%, 95% CI 88 to 96%) agreed or strongly agreed that research ethics committees could be better informed about distinct ethical issues surrounding CRTs. There was considerable variability among research ethics chairs with respect to the type of review required, as well as the identification of research subjects. The cluster-cluster and professional-cluster scenarios produced the most disagreement.
Research ethics committees identified a clear need for ethics guidelines for CRTs and education about distinct ethical issues in CRTs. There is disagreement among committees, even within the same countries, with respect to key questions in the ethics review of CRTs. This disagreement reflects variability of opinion and practices pointing toward possible gaps in knowledge, and supports the need for explicit guidelines for the ethical conduct and review of CRTs.
Cluster randomized trials; Informed consent; Research ethics guidelines; Research ethics review; Web-based survey
Several new primary care models have been implemented in Ontario, Canada over the past two decades. These practice models differ in team structure, physician remuneration, and group size. Few studies have examined the impact of these models on specialist referrals. We compared specialist referral rates amongst three primary care models: 1) Enhanced Fee-for-service, 2) Capitation- Non-Interdisciplinary (CAP-NI), 3) Capitation – Interdisciplinary (CAP-I).
We conducted a cross-sectional study using health administrative data from primary care practices in Ontario from April 1st, 2008 to March 31st, 2010. The analysis included all family physicians providing comprehensive care in one of the three models, had at least 100 patients, and did not have a prolonged absence (eight consecutive weeks). The primary outcome was referral rate (# of referrals to all medical specialties/1000 patients/year). A multivariable clustered Poisson regression analysis was used to compare referral rates between models while adjusting for provider (sex, years since graduation, foreign trained, time in current model) and patient (age, sex, income, rurality, health status) characteristics.
Fee-for-service had a significantly lower adjusted referral rate (676, 95% CI: 666-687) than the CAP-NI (719, 95% confidence interval (CI): 705-734) and CAP-I (694, 95% CI: 681-707) models and the interdisciplinary CAP-I group had a 3.5% lower referral rate than the CAP-NI group (RR = 0.965, 95% CI: 0.943-0.987, p = 0.002). Female and Canadian-trained physicians referred more often, while female, older, sicker and urban patients were more likely to be referred.
Primary care model is significantly associated with referral rate. On a study population level, these differences equate to 111,059 and 37,391 fewer referrals by fee-for-service versus CAP-NI and CAP-I, respectively – a difference of $22.3 million in initial referral appointment costs. Whether a lower rate of referral is more appropriate or not is not known and requires further investigation. Physician remuneration and team structure likely account for the differences; however, further investigation is also required to better understand whether other organizational factors associated with primary care model also impact referral.
Primary care; Specialist referral; Capitation; Primary care model
To determine whether models of primary care service delivery differ in their provision of family-centred care (FCC) and to identify practice characteristics associated with FCC.
Primary care practices in Ontario (ie, 35 salaried community health centres, 35 fee-for-service practices, 32 capitation-based health service organizations, and 35 blended remuneration family health networks) that belong to 4 models of primary care service delivery.
A total of 137 practices, 363 providers, and 5144 patients.
Main outcome measures
Measures of FCC in patient and provider surveys were based on the Primary Care Assessment Tool. Statistical analyses were conducted using linear mixed regression models and generalized estimating equations.
Patient-reported FCC scores were high and did not vary significantly by primary care model. Larger panel size in a practice was associated with lower odds of patients reporting FCC. Provider-reported FCC scores were significantly higher in community health centres than in family health networks (P = .035). A larger number of nurse practitioners and clinical services on-site were both associated with higher FCC scores, while scores decreased as the number of family physicians in a practice increased and if practices were more rural.
Based on provider and patient reports, primary care reform strategies that encourage larger practices and more patients per family physician might compromise the provision of FCC, while strategies that encourage multidisciplinary practices and a range of services might increase FCC.
The objective of this study was to compare the effect of thoracic paravertebral block (TPVB) and local anesthetic (LA) on persistent postoperative pain (PPP) 1 year following breast cancer surgery. Secondary objectives were to compare the effect on arm morbidity and quality of life.
Women scheduled for elective breast cancer surgery were randomly assigned to either TPVB or LA followed by general anesthesia. An NRS value of >3 at rest or with movement 1 year following surgery defined PPP. Blinded interim analysis suggested rates of PPP much lower than anticipated, making detection of the specified 20 % absolute reduction in the primary outcome impossible. Recruitment was stopped, and all enrolled patients were followed to 1 year.
A total of 145 participants were recruited; 65 were randomized to TPVB and 64 to LA. Groups were similar with respect to demographic and treatment characteristics. Only 9 patients (8 %; 95 % CI 4–14 %) met criteria for PPP 1 year following surgery; 5 were in the TPVB and 4 in the LA group. Brief Pain Inventory severity and interference scores were low in both groups. Arm morbidity and quality of life were similar in both groups. The 9 patients with PPP reported shoulder-arm morbidity and reduced quality of life.
This study reports a low incidence of chronic pain 1 year following major breast cancer surgery. Although PPP was uncommon at 1 year, it had a large impact on the affected patients’ arm morbidity and quality of life.
Continuity of care is essential for good quality diabetes management. We recently found that 46% of patients defaulted from care (had no contact with the clinic for 18 months after a follow-up appointment was ordered) in a Canadian multidisciplinary tertiary care diabetes clinic. The primary aim was to compare characteristics, diabetes processes of care, and outcomes from referral to within 1 year after leaving clinic or to the end of the follow-up period among those patients who defaulted, were discharged or were retained in the clinic.
Retrospective cohort study of 193 patients referred to the Foustanellas Endocrine and Diabetes Center (FEDC) for type 2 diabetes from January 1, 2005 to June 30, 2005. The FEDC is the primary academic referral centre for the Ottawa Region and provides multidisciplinary diabetes management. Defaulters (mean age 58.5 ± 12.5 year, 60% M) were compared to patients who were retained in the clinic (mean age 61.4 ± 10.47 years, 49% M) and those who were formally discharged (mean age 61.5 ± 13.2 years, 53.3% M). The chart audit population was then individually linked on an individual patient basis for laboratory testing, physician visits billed through OHIP, hospitalizations and emergency room visits using Ontario health card numbers to health administrative data from the Ministry of Health and Long-Term Care at the Institute for Clinical and Evaluative Sciences (ICES).
Retained and defaulted patients had significantly longer duration of diabetes, more microvascular complications, were more likely to be on insulin and less likely to have a HbA1c < 7.0% than patients discharged from clinic. A significantly lower proportion of patients who defaulted from tertiary care received recommended monitoring for their diabetes (HbA1c measurements, lipid measurements, and periodic eye examinations), despite no difference in median number of visits to a primary care provider (PCP). Emergency room visits were numerically higher in the defaulters group.
Patients defaulting from a tertiary care diabetes hospital do not receive the recommended monitoring for their diabetes management despite attending PCP appointments. Efforts should be made to minimize defaulting in this group of individuals.
The clinical pathway is a tool that operationalizes best evidence recommendations and clinical practice guidelines in an accessible format for ‘point of care’ management by multidisciplinary health teams in hospital settings. While high-quality, expert-developed clinical pathways have many potential benefits, their impact has been limited by variable implementation strategies and suboptimal research designs. Best strategies for implementing pathways into hospital settings remain unknown. This study will seek to develop and comprehensively evaluate best strategies for effective local implementation of externally developed expert clinical pathways.
We will develop a theory-based and knowledge user-informed intervention strategy to implement two pediatric clinical pathways: asthma and gastroenteritis. Using a balanced incomplete block design, we will randomize 16 community emergency departments to receive the intervention for one clinical pathway and serve as control for the alternate clinical pathway, thus conducting two cluster randomized controlled trials to evaluate this implementation intervention. A minimization procedure will be used to randomize sites. Intervention sites will receive a tailored strategy to support full clinical pathway implementation. We will evaluate implementation strategy effectiveness through measurement of relevant process and clinical outcomes. The primary process outcome will be the presence of an appropriately completed clinical pathway on the chart for relevant patients. Primary clinical outcomes for each clinical pathway include the following: Asthma—the proportion of asthmatic patients treated appropriately with corticosteroids in the emergency department and at discharge; and Gastroenteritis—the proportion of relevant patients appropriately treated with oral rehydration therapy. Data sources include chart audits, administrative databases, environmental scans, and qualitative interviews. We will also conduct an overall process evaluation to assess the implementation strategy and an economic analysis to evaluate implementation costs and benefits.
This study will contribute to the body of evidence supporting effective strategies for clinical pathway implementation, and ultimately reducing the research to practice gaps by operationalizing best evidence care recommendations through effective use of clinical pathways.
Clinical pathways; Key interventions; Intervention strategy; Pediatric emergency care; Theory-based strategy; Process outcomes; Clinical outcomes
Cluster randomized trials (CRTs) pose ethical challenges for investigators and ethics committees. This study describes the views and experiences of CRT researchers with respect to: (1) ethical challenges in CRTs; (2) the ethics review process for CRTs; and (3) the need for comprehensive ethics guidelines for CRTs.
Descriptive qualitative analysis of interviews conducted with a purposive sample of 20 experienced CRT researchers.
Informants expressed concern over the potential for bias that may result from requirements to obtain informed consent from research participants in CRTs. Informants suggested that the need for informed consent ought to be related to the type of intervention under study in a CRT. Informants rarely expressed concern regarding risks to research participants in CRTs, other than risks to privacy. Important issues identified in the research ethics literature, including fair subject selection and other justice issues, were not mentioned by informants. The ethics review process has had positive and negative impacts on CRT conduct. Informants stated that variability in ethics review between jurisdictions, and increasingly stringent ethics review in recent years, have hampered their ability to conduct CRTs. Many informants said that comprehensive ethics guidelines for CRTs would be helpful to researchers and research ethics committees.
Informants identified key ethical challenges in the conduct of CRTs, specifically relating to identifying subjects, seeking informed consent, and the use of gatekeepers. These data have since been used to identify topics for in-depth ethical analysis and to guide the development of comprehensive ethics guidelines for CRTs.
Cluster randomized trials; Research ethics; Informed consent; Clinical trials; Bioethics; Knowledge translation; Quality improvement; Implementation research
Food insecurity is a significant public health problem in North America and elsewhere. The prevalence of food insecurity varies by country of residence; within countries, it is strongly associated with household socioeconomic status, but the local environment may also play an important role. In this study, we analyzed secondary data from a population-based survey conducted in Québec, Canada, to determine if five local environmental factors: material and social deprivation, social cohesion, disorder, and living location were associated with changes in household food insecurity over a period of 6 years, while adjusting for household socioeconomic status (SES) and other factors.
Data from the Québec Longitudinal Study of Child Development, following same-aged children from 4–10 y of age, were analyzed using generalized estimating equations, to determine the longitudinal association between these environmental factors and food insecurity over a period of 6 years.
Of the 2120 children originally included in the cohort, 1746 (82%) were included in the present analysis. The prevalence of food insecurity was 9.2% when children were 4 y of age (95% CI: 7.8 – 10.6%) but no significant changes were observed over time. On average over the 6 year period, three environmental factors were positively related to food insecurity: high social deprivation (OR 1.62, 95%CI: 1.16 – 2.26), low social cohesion (OR 1.45 95%CI: 1.10 – 1.92), and high disorder (OR 1.76, 95%CI: 1.37 – 2.27), while living location and material deprivation were not related to food insecurity. These associations were independent of household SES and other social variables.
These results highlight the potential role of the local social environment in preventing and ameliorating food insecurity at the household level. Stakeholders providing food security interventions at the community level should consider interactions with local social characteristics and perhaps changing the social environment itself. Further intervention research also examining interactions with household-level factors could lead to the development of interventions that increase both household and community-level food security.
Food insecurity; Social capital; Social cohesion; Disorder; Deprivation; Neighbourhood; Longitudinal study; Environment; Context
The Ottawa Ethics of Cluster Trials Consensus Group sets out 15 recommendations for the ethical design and conduct of cluster randomized trials.
To determine the association between local environmental factors with child weight status in a longitudinal study, using a semi-parametric, group-based method, while also considering social and early life factors.
Standardized, directly measured BMI from 4–10 y of age, and group-based trajectory modeling (PROC TRAJ) were used to estimate developmental trajectories of weight change in a Québec birth cohort (n = 1,566). Associations between the weight trajectories and living location, social cohesion, disorder, and material and social deprivation were estimated after controlling for social and early life factors.
Four weight trajectory groups were estimated: low-increasing (9.7%); low-medium, accelerating (36.2%); medium-high, increasing (43.0%); and high-stable (11.1%). In the low-increasing and medium-high trajectory groups, living in a semi-urban area was inversely related to weight, while living in a rural area was positively related to weight in the high-stable group. Disorder was inversely related to weight in the low-increasing group only. Other important risk factors for high-stable weight included obesity status of the mother, smoking during pregnancy, and overeating behaviors.
In this study, associations between local environment factors and weight differed by trajectory group. Early life factors appear to play a more consistent role in weight status. Further work is needed to determine the influence of place on child weight.
Primary care plays a key role in the prevention and management of cardiovascular disease (CVD). We examined primary care practice adherence to recommended care guidelines associated with the prevention and management of CVD for high risk patients.
We conducted a secondary analysis of cross-sectional baseline data collected from 84 primary care practices participating in a large quality improvement initiative in Eastern Ontario from 2008 to 2010. We collected medical chart data from 4,931 patients who either had, or were at high risk of developing CVD to study adherence rates to recommended guidelines for CVD care and to examine the proportion of patients at target for clinical markers such as blood pressure, lipid levels and hemoglobin A1c.
Adherence to preventive care recommendations was poor. Less than 10% of high risk patients received a waistline measurement, half of the smokers received cessation advice, and 7.7% were referred to a smoking cessation program. Gaps in care exist for diabetes and kidney disease as 54.9% of patients with diabetes received recommended hemoglobin-A1c screenings, and only 55.8% received an albumin excretion test. Adherence rates to recommended guidelines for coronary artery disease, hypertension, and dyslipidemia were high (>75%); however <50% of patients were at target for blood pressure or LDL-cholesterol levels (37.1% and 49.7% respectively), and only 59.3% of patients with diabetes were at target for hemoglobin-A1c.
There remain significant opportunities for primary care providers to engage high risk patients in prevention activities such as weight management and smoking cessation. Despite high adherence rates for hypertension, dyslipidemia, and coronary artery disease, a significant proportion of patients failed to meet treatment targets, highlighting the complexity of caring for people with multiple chronic conditions.
Cardiovascular disease; Primary care; Diabetes; Evidence-based care; Preventive care; Quality of care
This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, we set out six areas of inquiry that must be addressed if the CRT is to be set on a firm ethical foundation. This paper addresses the sixth of the questions posed, namely, what is the role and authority of gatekeepers in CRTs in health research? ‘Gatekeepers’ are individuals or bodies that represent the interests of cluster members, clusters, or organizations. The need for gatekeepers arose in response to the difficulties in obtaining informed consent because of cluster randomization, cluster-level interventions, and cluster size. In this paper, we call for a more restrictive understanding of the role and authority of gatekeepers.
Previous papers in this series have provided solutions to the challenges posed by informed consent in CRTs without the need to invoke gatekeepers. We considered that consent to randomization is not required when cluster members are approached for consent at the earliest opportunity and before any study interventions or data-collection procedures have started. Further, when cluster-level interventions or cluster size means that obtaining informed consent is not possible, a waiver of consent may be appropriate. In this paper, we suggest that the role of gatekeepers in protecting individual interests in CRTs should be limited. Generally, gatekeepers do not have the authority to provide proxy consent for cluster members. When a municipality or other community has a legitimate political authority that is empowered to make such decisions, cluster permission may be appropriate; however, gatekeepers may usefully protect cluster interests in other ways. Cluster consultation may ensure that the CRT addresses local health needs, and is conducted in accord with local values and customs. Gatekeepers may also play an important role in protecting the interests of organizations, such as hospitals, nursing homes, general practices, and schools. In these settings, permission to access the organization relies on resource implications and adherence to institutional policies.
The objective of this paper was to determine the influence of place factors on weight gain in a contemporary cohort of children while also adjusting for early life and individual/family social factors. Participants from the Québec Longitudinal Study of Child Development comprised the sample for analysis (n = 1,580). A mixed-effects regression analysis was conducted to determine the longitudinal relationship between these place factors and standardized BMI, from age 4 to 10 years. The average relationship with time was found to be quadratic (rate of weight gain increased over time). Neighborhood material deprivation was found to be positively related to weight gain. Social deprivation, social disorder, and living in a medium density area were inversely related, while no association was found for social cohesion. Early life factors and genetic proxies appeared to be important in explaining weight gain in this sample. This study suggests that residential environments may play a role in childhood weight change; however, pathways are likely to be complex and interacting and perhaps not as important as early life factors and genetic proxies. Further work is required to clarify these relationships.
Children; Neighborhood; Residential characteristics; Environment; Body weight; Body mass index; Longitudinal study; Mixed-models; Social factors
Despite evidence-based recommendations supporting long-term use of cardiac medications in patients post ST-elevation myocardial infarction, adherence is known to decline over time. Discontinuation of cardiac medications in such patients is associated with increased mortality.
This is a pragmatic, cluster-randomized controlled trial with blinded outcome assessment and embedded qualitative process evaluation. Patients from one health region in Ontario, Canada who undergo a coronary angiogram during their admission for ST-elevation myocardial infarction and who survive their initial hospitalization will be included. Allocation of eligible patients to intervention or usual care will take place within one week after the angiogram using a computer-generated random sequence. To avoid treatment contamination, patients treated by the same family physician will be allocated to the same study arm. The intervention consists of recurrent, personalized, paper-based educational messages and reminders sent via post on behalf of the interventional cardiologist to the patient, family physician, and pharmacist urging long-term adherence to secondary prevention medications. The primary outcome is the proportion of patients who report in a phone interview taking all relevant classes of cardiac medications at twelve months. Secondary outcomes to be measured at three and twelve months include proportions of patients who report: actively taking each cardiac medication class of interest (item-by-item); stopping medications due to side effects; taking one or two or three medication classes concurrently; a perfect Morisky Medication Adherence Score for cardiac medication compliance; and having a discussion with their family physician about long-term adherence to cardiac medications. Self-reported measures of adherence will be validated using administrative data for prescriptions filled.
This intervention is designed to be easily generalizable. If effective, it could be implemented broadly. If it does not change medication utilization, the process evaluation will offer insights regarding how such an intervention could be optimized in future.
Randomized trial; Medication adherence; Reminders
The effect of hospital-acquired infection with Clostridium difficile on length of stay in hospital is not yet fully understood. We determined the independent impact of hospital-acquired infection with C. difficile on length of stay in hospital.
We conducted a retrospective observational cohort study of admissions to hospital between July 1, 2002, and Mar. 31, 2009, at a single academic hospital. We measured the association between infection with hospital-acquired C. difficile and time to discharge from hospital using Kaplan–Meier methods and a Cox multivariable proportional hazards regression model. We controlled for baseline risk of death and accounted for C. difficile as a time-varying effect.
Hospital-acquired infection with C. difficile was identified in 1393 of 136 877 admissions to hospital (overall risk 1.02%, 95% confidence interval [CI] 0.97%–1.06%). The crude median length of stay in hospital was greater for patients with hospital-acquired C. difficile (34 d) than for those without C. difficile (8 d). Survival analysis showed that hospital-acquired infection with C. difficile increased the median length of stay in hospital by six days. In adjusted analyses, hospital-acquired C. difficile was significantly associated with time to discharge, modified by baseline risk of death and time to acquisition of C. difficile. The hazard ratio for discharge by day 7 among patients with hospital-acquired C. difficile was 0.55 (95% CI 0.39–0.70) for patients in the lowest decile of baseline risk of death and 0.45 (95% CI 0.32–0.58) for those in the highest decile; for discharge by day 28, the corresponding hazard ratios were 0.74 (95% CI 0.60–0.87) and 0.61 (95% CI 0.53–0.68).
Hospital-acquired infection with C. difficile significantly prolonged length of stay in hospital independent of baseline risk of death.