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.
Primary care providers play an important role in preventing and managing cardiovascular disease. This study compared the quality of preventive cardiovascular care delivery amongst different primary care models.
This is a secondary analysis of a larger randomized control trial, known as the Improved Delivery of Cardiovascular Care (IDOCC) through Outreach Facilitation. Using baseline data collected through IDOCC, we conducted a cross-sectional study of 82 primary care practices from three delivery models in Eastern Ontario, Canada: 43 fee-for-service, 27 blended-capitation and 12 community health centres with salary-based physicians. Medical chart audits from 4,808 patients with or at high risk of developing cardiovascular disease were used to examine each practice's adherence to ten evidence-based processes of care for diabetes, chronic kidney disease, dyslipidemia, hypertension, weight management, and smoking cessation care. Generalized estimating equation models adjusting for age, sex, rurality, number of cardiovascular-related comorbidities, and year of data collection were used to compare guideline adherence amongst the three models.
The percentage of patients with diabetes that received two hemoglobin A1c tests during the study year was significantly higher in community health centres (69%) than in fee-for-service (45%) practices (Adjusted Odds Ratio (AOR) = 2.4 [95% CI 1.4-4.2], p = 0.001). Blended capitation practices had a significantly higher percentage of patients who had their waistlines monitored than in fee-for-service practices (19% vs. 5%, AOR = 3.7 [1.8-7.8], p = 0.0006), and who were recommended a smoking cessation drug when compared to community health centres (33% vs. 16%, AOR = 2.4 [1.3-4.6], p = 0.007). Overall, quality of diabetes care was higher in community health centres, while smoking cessation care and weight management was higher in the blended-capitation models. Fee-for-service practices had the greatest gaps in care, most noticeably in diabetes care and weight management.
This study adds to the evidence suggesting that primary care delivery model impacts quality of care. These findings support current Ontario reforms to move away from the traditional fee-for-service practice.
Urgent, unplanned hospital readmissions are increasingly being used to gauge the quality of care. We reviewed urgent readmissions to determine which were potentially avoidable and compared rates of all-cause and avoidable readmissions.
In a multicentre, prospective cohort study, we reviewed all urgent readmissions that occurred within six months among patients discharged to the community from 11 teaching and community hospitals between October 2002 and July 2006. Summaries of the readmissions were reviewed by at least four practising physicians using standardized methods to judge whether the readmission was an adverse event (poor clinical outcome due to medical care) and whether the adverse event could have been avoided. We used a latent class model to determine whether the probability that each readmission was truly avoidable exceeded 50%.
Of the 4812 patients included in the study, 649 (13.5%, 95% confidence interval [CI] 12.5%–14.5%) had an urgent readmission within six months after discharge. We considered 104 of them (16.0% of those readmitted, 95% CI 13.3%–19.1%; 2.2% of those discharged, 95% CI 1.8%–2.6%) to have had a potentially avoidable readmission. The proportion of patients who had an urgent readmission varied significantly by hospital (range 7.5%–22.5%; χ2 = 92.9, p < 0.001); the proportion of readmissions deemed avoidable did not show significant variation by hospital (range 1.2%–3.7%; χ2 = 12.5, p < 0.25). We found no association between the proportion of patients who had an urgent readmission and the proportion of patients who had an avoidable readmission (Pearson correlation 0.294; p = 0.38). In addition, we found no association between hospital rankings by proportion of patients readmitted and rankings by proportion of patients with an avoidable readmission (Spearman correlation coefficient 0.28, p = 0.41).
Urgent readmissions deemed potentially avoidable were relatively uncommon, comprising less than 20% of all urgent readmissions following hospital discharge. Hospital-specific proportions of patients who were readmitted were not related to proportions with a potentially avoidable readmission.
There is a need to find innovative approaches for translating best practices for chronic disease care into daily primary care practice routines. Primary care plays a crucial role in the prevention and management of cardiovascular disease. There is, however, a substantive care gap, and many challenges exist in implementing evidence-based care. The Improved Delivery of Cardiovascular Care (IDOCC) project is a pragmatic trial designed to improve the delivery of evidence-based care for the prevention and management of cardiovascular disease in primary care practices using practice outreach facilitation.
The IDOCC project is a stepped-wedge cluster randomized control trial in which Practice Outreach Facilitators work with primary care practices to improve cardiovascular disease prevention and management for patients at highest risk. Primary care practices in a large health region in Eastern Ontario, Canada, were eligible to participate. The intervention consists of regular monthly meetings with the Practice Outreach Facilitator over a one- to two-year period. Starting with audit and feedback, consensus building, and goal setting, the practices are supported in changing practice behavior by incorporating chronic care model elements. These elements include (a) evidence-based decision support for providers, (b) delivery system redesign for practices, (c) enhanced self-management support tools provided to practices to help them engage patients, and (d) increased community resource linkages for practices to enhance referral of patients. The primary outcome is a composite score measured at the level of the patient to represent each practice's adherence to evidence-based guidelines for cardiovascular care. Qualitative analysis of the Practice Outreach Facilitators' written narratives of their ongoing practice interactions will be done. These textual analyses will add further insight into understanding critical factors impacting project implementation.
This pragmatic, stepped-wedge randomized controlled trial with both quantitative and process evaluations demonstrates innovative methods of implementing large-scale quality improvement and evidence-based approaches to care delivery. This is the first Canadian study to examine the impact of a large-scale multifaceted cardiovascular quality-improvement program in primary care. It is anticipated that through the evaluation of IDOCC, we will demonstrate an effective, practical, and sustainable means of improving the cardiovascular health of patients across Canada.
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 cluster trial is to be set on a firm ethical foundation. This paper addresses the second of the questions posed, namely, from whom, when, and how must informed consent be obtained in CRTs in health research? The ethical principle of respect for persons implies that researchers are generally obligated to obtain the informed consent of research subjects. Aspects of CRT design, including cluster randomization, cluster level interventions, and cluster size, present challenges to obtaining informed consent. Here we address five questions related to consent and CRTs: How can a study proceed if informed consent is not possible? Is consent to randomization always required? What information must be disclosed to potential subjects if their cluster has already been randomized? Is passive consent a valid substitute for informed consent? Do health professionals have a moral obligation to participate as subjects in CRTs designed to improve professional practice?
We set out a framework based on the moral foundations of informed consent and international regulatory provisions to address each of these questions. First, when informed consent is not possible, a study may proceed if a research ethics committee is satisfied that conditions for a waiver of consent are satisfied. Second, informed consent to randomization may not be required if it is not possible to approach subjects at the time of randomization. Third, when potential subjects are approached after cluster randomization, they must be provided with a detailed description of the interventions in the trial arm to which their cluster has been randomized; detailed information on interventions in other trial arms need not be provided. Fourth, while passive consent may serve a variety of practical ends, it is not a substitute for valid informed consent. Fifth, while health professionals may have a moral obligation to participate as subjects in research, this does not diminish the necessity of informed consent to study participation.
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 first of the questions posed, namely, who is the research subject in a CRT in health research? The identification of human research subjects is logically prior to the application of protections as set out in research ethics and regulation. Aspects of CRT design, including the fact that in a single study the units of randomization, experimentation, and observation may differ, complicate the identification of human research subjects. But the proper identification of human research subjects is important if they are to be protected from harm and exploitation, and if research ethics committees are to review CRTs efficiently.
We examine the research ethics literature and international regulations to identify the core features of human research subjects, and then unify these features under a single, comprehensive definition of human research subject. We define a human research subject as any person whose interests may be compromised as a result of interventions in a research study. Individuals are only human research subjects in CRTs if: (1) they are directly intervened upon by investigators; (2) they interact with investigators; (3) they are deliberately intervened upon via a manipulation of their environment that may compromise their interests; or (4) their identifiable private information is used to generate data. Individuals who are indirectly affected by CRT study interventions, including patients of healthcare providers participating in knowledge translation CRTs, are not human research subjects unless at least one of these conditions is met.
Clinicians informally assess changes in patients' status over time to prognosticate their outcomes. The incorporation of trends in patient status into regression models could improve their ability to predict outcomes. In this study, we used a unique approach to measure trends in patient hospital death risk and determined whether the incorporation of these trend measures into a survival model improved the accuracy of its risk predictions.
We included all adult inpatient hospitalizations between 1 April 2004 and 31 March 2009 at our institution. We used the daily mortality risk scores from an existing time-dependent survival model to create five trend indicators: absolute and relative percent change in the risk score from the previous day; absolute and relative percent change in the risk score from the start of the trend; and number of days with a trend in the risk score. In the derivation set, we determined which trend indicators were associated with time to death in hospital, independent of the existing covariates. In the validation set, we compared the predictive performance of the existing model with and without the trend indicators.
Three trend indicators were independently associated with time to hospital mortality: the absolute change in the risk score from the previous day; the absolute change in the risk score from the start of the trend; and the number of consecutive days with a trend in the risk score. However, adding these trend indicators to the existing model resulted in only small improvements in model discrimination and calibration.
We produced several indicators of trend in patient risk that were significantly associated with time to hospital death independent of the model used to create them. In other survival models, our approach of incorporating risk trends could be explored to improve their performance without the collection of additional data.
A high quality decision requires that patients who meet clinical criteria for surgery are informed about the options (including non-surgical alternatives) and receive treatments that match their goals. The aim of this study was to evaluate the psychometric properties and clinical sensibility of a patient self report instrument, to measure the quality of decisions about total joint replacement for knee or hip osteoarthritis.
The performance of the Hip/Knee Osteoarthritis Decision Quality Instrument (HK-DQI) was evaluated in two samples: (1) a cross-sectional mail survey with 489 patients and 77 providers (study 1); and (2) a randomized controlled trial of a patient decision aid with 138 osteoarthritis patients considering total joint replacement (study 2). The HK-DQI results in two scores. Knowledge items are summed to create a total knowledge score, and a set of goals and concerns are used in a logistic regression model to develop a concordance score. The concordance score measures the proportion of patients whose treatment matched their goals. Hypotheses related to acceptability, feasibility, reliability and validity of the knowledge and concordance scores were examined.
In study 1, the HK-DQI was completed by 382 patients (79%) and 45 providers (58%), and in study 2 by 127 patients (92%), with low rates of missing data. The DQI-knowledge score was reproducible (ICC = 0.81) and demonstrated discriminant validity (68% decision aid vs. 54% control, and 78% providers vs. 61% patients) and content validity. The concordance score demonstrated predictive validity, as patients whose treatments were concordant with their goals had more confidence and less regret with their decision compared to those who did not.
The HK-DQI is feasible and acceptable to patients. It can be used to assess whether patients with osteoarthritis are making informed decisions about surgery that are concordant with their goals.
shared decision making; patient centered care; quality measurement; osteoarthritis; total joint replacement; decision quality
Objectives To investigate the extent to which authors of cluster randomised trials adhered to two basic requirements of the World Medical Association’s Declaration of Helsinki and the International Committee of Medical Journal Editors’ uniform requirements for manuscripts (namely, reporting of research ethics review and informed consent), to determine whether the adequacy of reporting has improved over time, and to identify characteristics of cluster randomised trials associated with reporting of ethics practices.
Design Review of a random sample of published cluster randomised trials from an electronic search in Medline.
Setting Cluster randomised trials in health research published in English language journals from 2000 to 2008.
Study sample 300 cluster randomised trials published in 150 journals.
Results 77 (26%, 95% confidence interval 21% to 31%) trials failed to report ethics review. The proportion reporting ethics review increased significantly over time (P<0.001). Trials with data collection interventions at the individual level were more likely to report ethics review than were trials that used routine data sources only (79% (n=151) v 55% (23); P=0.008). Trials that accounted for clustering in the design and analysis were more likely to report ethics review. The median impact factor of the journal of publication was higher for trials that reported ethics review (3.4 v 2.3; P<0.001). 93 (31%, 26% to 36%) trials failed to report consent. Reporting of consent increased significantly over time (P<0.001). Trials with interventions targeting participants at the individual level were more likely to report consent than were trials with interventions targeting the cluster level (87% (90) v 48% (41); P<0.001). Trials with data collection interventions at the individual level were more likely to report consent than were those that used routine data sources only (78% (146) v 29% (11); P<0.001).
Conclusions Reporting of research ethics protections in cluster randomised trials is inadequate. In addition to research ethics approval, authors should report whether informed consent was sought, from whom consent was sought, and what consent was for.