Structure, processes, and initial outcomes of The Ottawa Hospital Multi-Specialist Limb-Preservation Clinic and Programme: A unique-in-Canada quality improvement initiative.

In 2017, The Ottawa Hospital initiated a unique-in-Canada quality improvement initiative by opening a novel, multi-specialist limb-preservation clinic. We sought to describe the structure, processes, and initial outcomes of the clinic and evaluate whether it is achieving its mandate of providing high-quality wound clinical care, education, and research. We conducted a descriptive prospective cohort study alongside a nested study of 162 clinic patients requiring serial assessments. There have been 1623 visits, mostly (72.2%) from outpatients. During 17.8% of visits, patients were evaluated by >1 specialist. Therapies provided most often included negative-pressure wound therapy (32.7%), biological wound dressings (21.6%), and total contact casting (18.5%). Furthermore, 1.2% underwent toe/ray amputations or skin grafting in clinic and 22.8% were initiated on antimicrobials. Mixed-effects models suggested that mean wound volumes for those requiring serial assessments decreased by 1.6 (95% confidence interval = -0.86 to -2.27) cm3 between visits. The clinic provided seven rotations to vascular surgery, infectious diseases, dermatology, and palliative care physicians; three nursing preceptorships; and two educational workshops. It also initiated provincial and national vascular health and wound care research initiatives. This study may be used to guide development of other limb-preservation clinics and programmes. Findings support that our programme is achieving its mandate.

Development and evaluation of a quality improvement framework for healthcare.

OBJECTIVE: Develop and evaluate a framework for quality improvement which will provide a common approach, terminology and greater likelihood of success in achieving demonstrable and sustained improvement. DESIGN: Descriptive with mixed methods evaluation. SETTING: Tertiary care academic hospital in Ottawa, Canada. PARTICIPANTS: Students enrolled in the Quality and Patient Safety Leadership Executive Program at the local university. METHODS: The quality improvement (QI) framework was developed though comparison and coding of key strengths across four commonly applied quality improvement frameworks. Effectiveness of the framework was evaluated through a satisfaction survey of students who were taught the framework, and independent assessment of student improvement initiatives that followed the QI Framework versus initiatives from a prior year who did not. MAIN OUTCOME MEASURES: Acceptability and effectiveness of the QI Framework. RESULTS: All participants found the QI Framework to be useful and easy to follow. Independent evaluation of improvement initiatives following the QI Framework, as compared to those that did not, scored higher (95% CI: 3.0 ± 0.49) than the projects completed without the QI Framework (95% CI: 2.2 ± 0.30), P value < 0.01. Scores were higher for cohort 2017/18 in all criteria except scaling and spreading, in which there was no change (2015/16 95% CI: 1.2 ± 0.24, 2017/18 95% CI: 1.2 ± 0.38). CONCLUSIONS: The method we have developed is acceptable and helpful to users, and overall application resulted in higher quality initiatives. We believe this method, which we have branded as The Ottawa Hospital Innovation Framework, can be beneficial in healthcare settings for a variety of change initiatives.

Potential harms associated with routine collection of patient sociodemographic information: A rapid review.

BACKGROUND: Health systems are recommended to capture routine patient sociodemographic data as a key step in providing equitable person-centred care. However, collection of this information has the potential to cause harm, especially for vulnerable or potentially disadvantaged patients. OBJECTIVE: To identify harms perceived or experienced by patients, their families, or health-care providers from collection of sociodemographic information during routine health-care visits and to identify best practices for when, by whom and how to collect this information. SEARCH STRATEGY: We searched OVID MEDLINE, PubMed "related articles" via NLM and healthevidence.org to the end of January 2018 and assessed reference lists and related citations of included studies. INCLUSION CRITERIA: We included studies reporting on harms of collecting patient sociodemographic information in health-care settings. DATA EXTRACTION AND SYNTHESIS: Data on study characteristics and types of harms were extracted and summarized narratively. MAIN RESULTS: Eighteen studies were included; 13 provided patient perceptions or experiences with the collection of these data and seven studies reported on provider perceptions. Five reported on patient recommendations for collecting sociodemographic information. Patients and providers reported similar potential harms which were grouped into the following themes: altered behaviour which may affect care-seeking, data misuse or privacy concerns, discomfort, discrimination, offence or negative reactions, and quality of care. Patients suggested that sociodemographic information be collected face to face by a physician. DISCUSSION AND CONCLUSIONS: Overall, patients support the collection of sociodemographic information. However, harms are possible, especially for some population subgroups. Harms may be mitigated by providing a rationale for the collection of this information.

A pre and post intervention study to reduce unnecessary urinary catheter use on general internal medicine wards of a large academic health science center.

BACKGROUND: Urinary catheters are a common medical intervention, yet they can also be associated with harmful adverse events such as infection, urinary tract trauma, delirium and patient discomfort. The purpose of this study was to describe the use of the SafetyLEAP program to drive improvement efforts, and specifically to reduce the use of urinary catheters on general internal medicine wards. METHODS: A pre and post intervention study using the SafetyLEAP program was performed with urinary catheter prevalence as the primary outcome on two general internal medicine wards in a large academic health sciences center. RESULTS: A total of n = 534 patients (n = 283 from ward #1; and n = 252 from ward #2) were included in the initial audit and feedback portion of the study and 1601 patients (n = 824 pre-intervention and n = 777 post-intervention were included in the planned quality improvement portion of the study). A total of 379 patients during the quality improvement intervention had a urinary catheter. Overall, the adherence to the SafetyLEAP program was 97.4% on both general internal medicine wards. The daily catheter point prevalence decreased from 22 to 13%. After the implementation of the program, the urinary catheter utilization ratio (defined as urinary catheter days/patient days) declined from 0.14 to 0.12. Catheter-associated urinary tract infections (CAUTI) were unchanged. CONCLUSION: The SafetyLEAP program can help provide a systematic approach to the detection, and reduction of safety incidents. Future studies should aim at refining and implementing this intervention broadly.

Implementation of a multimodal patient safety improvement program "SafetyLEAP" in intensive care units.

Purpose Patient safety remains a top priority in healthcare. Many organizations have developed systems to monitor and prevent harm, and have invested in different approaches to quality improvement. Despite these organizational efforts to better detect adverse events, efficient resolution of safety problems remains a significant challenge. The authors developed and implemented a comprehensive multimodal patient safety improvement program called SafetyLEAP. The term "LEAP" is an acronym that highlights the three facets of the program including: a Leadership and Engagement approach; Audit and feedback; and a Planned improvement intervention. The purpose of this paper is to evaluate the implementation of the SafetyLEAP program in the intensive care units (ICUs) of three large hospitals. Design/methodology/approach A comparative case study approach was used to compare and contrast the adherence to each component of the SafetyLEAP program. The study was conducted using a convenience sample of three ( n=3) ICUs from two provinces. Two reviewers independently evaluated major adherence metrics of the SafetyLEAP program for their completeness. Analysis was performed for each individual case, and across cases. Findings A total of 257 patients were included in the study. Overall, the proportion of the SafetyLEAP tasks completed was 64.47, 100, and 26.32 percent, respectively. ICU nos 1 and 2 were able to identify opportunities for improvement, follow a quality improvement process and demonstrate positive changes in patient safety. The main factors influencing adherence were the engagement of a local champion, competing priorities, and the identification of appropriate resources. Practical implications The SafetyLEAP program allowed for the identification of processes that could result in patient harm in the ICUs. However, the success in improving patient safety was dependent on the engagement of the care teams. Originality/value The authors developed an evidence-based approach to systematically and prospectively detect, improve, and evaluate actions related to patient safety.

The influence of incidental abdominal aortic aneurysm monitoring on patient outcomes.

BACKGROUND: Incidental abdominal aortic aneurysms (AAAs) are identified when the abdomen is imaged for other reasons. These are common, and many undergo incomplete radiological monitoring. The association between monitoring completeness and population-based outcomes has not been studied. METHODS: A cohort of incidental AAAs (defined as previously unidentified aortic enlargement exceeding 3 cm found on an imaging study done for another reason) was linked to population-based data. Patients were followed to elective AAA repair, AAA rupture, death, or March 31, 2009. Monitoring completeness was gauged as the sequential number of months without a recommended abdominal scan. Its association with time to elective AAA repair and time to death was measured using a multivariable Cox regression model adjusting for other important covariates. RESULTS: We identified 191 incidental AAAs between 1996 and 2004 (median diameter of 3.5 cm [range, 3.0-5.3 cm], median follow up of 4.4 years [range, 0.6-12.7 years]). During the study, patients spent a median of 19.4% of their time with incomplete AAA monitoring (interquartile range [IQR] 0.3%-44%); 56 patients (29.3%) had no follow-up imaging of their aneurysm. Nineteen patients (10.0%; 2.0% per year) underwent elective AAA repair, and 79 patients (37.7%; 7.6% per year) died. Independent of important covariates, people were significantly less likely to undergo elective repair (hazard ratio [HR], 0.03) and significantly more likely to die (HR, 2.99) if their AAA went without radiological monitoring for 1 year. CONCLUSIONS: Incomplete incidental AAA radiological monitoring was significantly associated with a decreased risk of elective AAA repair and an increased risk of death. While uncontrolled confounding might explain part of these associations, clinicians should ensure that radiological monitoring of AAAs is complete in appropriate patients.

Proportion of hospital readmissions deemed avoidable: a systematic review.

BACKGROUND: Readmissions to hospital are increasingly being used as an indicator of quality of care. However, this approach is valid only when we know what proportion of readmissions are avoidable. We conducted a systematic review of studies that measured the proportion of readmissions deemed avoidable. We examined how such readmissions were measured and estimated their prevalence. METHODS: We searched the MEDLINE and EMBASE databases to identify all studies published from 1966 to July 2010 that reviewed hospital readmissions and that specified how many were classified as avoidable. RESULTS: Our search strategy identified 34 studies. Three of the studies used combinations of administrative diagnostic codes to determine whether readmissions were avoidable. Criteria used in the remaining studies were subjective. Most of the studies were conducted at single teaching hospitals, did not consider information from the community or treating physicians, and used only one reviewer to decide whether readmissions were avoidable. The median proportion of readmissions deemed avoidable was 27.1% but varied from 5% to 79%. Three study-level factors (teaching status of hospital, whether all diagnoses or only some were considered, and length of follow-up) were significantly associated with the proportion of admissions deemed to be avoidable and explained some, but not all, of the heterogeneity between the studies. INTERPRETATION: All but three of the studies used subjective criteria to determine whether readmissions were avoidable. Study methods had notable deficits and varied extensively, as did the proportion of readmissions deemed avoidable. The true proportion of hospital readmissions that are potentially avoidable remains unclear.

Incidence of potentially avoidable urgent readmissions and their relation to all-cause urgent readmissions.

BACKGROUND: 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. METHODS: 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%. RESULTS: 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%; χ(2) = 92.9, p < 0.001); the proportion of readmissions deemed avoidable did not show significant variation by hospital (range 1.2%-3.7%; χ(2) = 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). INTERPRETATION: 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.

Disability, pain, and wound-specific concerns self-reported by adults at risk of limb loss: A cross-sectional study using the World Health Organization Disability Assessment Schedule 2.0.

INTRODUCTION: There has been limited study of patient-reported outcomes (PROs) in patients at risk of limb loss. Our primary objective was to estimate the prevalence of disability in this patient population using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0). MATERIALS AND METHODS: We recruited patients referred to a limb-preservation clinic. Patients self-reported their disability status using the 12-domain WHODAS 2.0. Severity of disability in each domain was scored from 1 = none to 5 = extreme and the total normalized to a 100-point scale (total score ≥25 = clinically significant disability). We also asked patients about wound-specific concerns and wound-related discomfort or distress. RESULTS: We included 162 patients. Reasons for clinic referral included arterial-insufficient (37.4%), postoperative (25.9%), and mixed etiology (10.8%) wounds. The mean WHODAS 2.0 disability score was 35.0 (standard deviation = 16.0). One-hundred-and-nineteen (73.5%) patients had clinically significant disability. Patients reported they had the greatest difficulty walking a long distance (mean score = 4.2), standing for long periods of time (mean score = 3.6), taking care of household responsibilities (mean score = 2.7), and dealing with the emotional impact of their health problems (mean score = 2.5). In the two-weeks prior to presentation, 87 (52.7%) patients expressed concern over their wound(s) and 90 (55.6%) suffered a moderate amount or great deal of wound-related discomfort or distress. In adjusted ordinary least squares regression models, although WHODAS 2.0 disability scores varied with changes in wound volume (p = 0.03) and total revised photographic wound assessment tool scores (p<0.001), the largest decrease in disability severity was seen in patients with less wound-specific concerns and wound-related discomfort and distress. DISCUSSION: The majority of people at risk of limb loss report suffering a substantial burden of disability, pain, and wound-specific concerns. Research is needed to further evaluate the WHODAS 2.0 in a multicenter fashion among these patients and determine whether care and interventions may improve their PROs.

Quantification of oligodendrocyte progenitor cells in human and cat optic nerve: implications for endogenous repair in multiple sclerosis.

In multiple sclerosis (MS), one strategy to reduce disability is enhancement of endogenous repair by remyelinating oligodendrocytes derived from oligodendrocyte progenitor cells (OP). An important prerequisite is determining the abundance of OP relative to oligodendrocytes in normal human central nervous system (CNS), which, in turn, requires reliable OP identification. To achieve this, cat and human optic nerves (ON) were subjected to varied preparation protocols, and the resultant neuroglial staining profiles correlated to generate an antigenic phenotype for OP applicable to human autopsy specimens. OP, interchangeably called NG2cells due to universal NG2 expression, were shown to comprise a separate class of neuroglial cells, related to oligodendrocytes by expression of the oligodendrocyte lineage transcription factors, Olig1 and Olig2. Despite their morphological complexity, including contact with axons and other neuroglia, NG2cells all appear capable of responding as OP to counter local oligodendrocyte loss. However, quantification revealed that NG2cells comprised less than 5% of the neuroglia and had a ratio to oligodendrocytes of about 1:10, not only in human and cat ON but also in white and gray-matter regions of cat spinal cord. The finding that NG2cells are not abundant, particularly relative to oligodendrocytes, may have implications for efforts to enhance endogenous repair in MS.

Incidence, follow-up, and outcomes of incidental abdominal aortic aneurysms.

BACKGROUND: Incidental abdominal aortic aneurysms (AAAs) are identified during imaging for other reasons. Incidental AAAs are important findings because they require monitoring and surgical treatment, when indicated, to prevent rupture. The prevalence of incidental AAAs and their management has not been extensively studied. METHODS: We electronically screened a 25% simple random sample of abdominal computed tomography (CT), ultrasound (US), and magnetic resonance imaging (MRI) studies conducted between 1996 and 2008 at one academic medical center. Screen-positive reports were manually reviewed to determine if they showed an incidental AAA. We reviewed the medical records of all in-patients to determine whether the incidental AAA was documented, a treatment plan was identified, and whether it was communicated to the patient's family physician through the discharge summary. We used evidence-based recommended schedules to determine the adequacy of AAA monitoring for each person. RESULTS: In 79,121 abdominal images, we identified 812 incidental AAAs (1.0% of all studies) or 364 incidental AAAs annually (95% confidence interval [CI], 349-379). Patients were elderly (mean age, 74 years), and AAAs were a mean diameter of 4.0 cm. For 174 inpatients, AAAs were noted in only 51 patients (29%) and only 25 (15%) were communicated to the family physician. Of 329 patients who were observed beyond their first recommended follow-up scan, only 51 (16%) were monitored appropriately throughout their entire follow-up; the median proportion of follow-up time with recommended monitoring was 56% (interquartile range, 32%-82%). Elective AAA repair was done in 98 patients (13%), the probability of which was significantly increased when AAA monitoring frequency was compliant with that recommended in practice guidelines. Six patients (0.8%) were admitted with aortic rupture, the probability of which was independent of AAA monitoring. CONCLUSION: Incidental AAAs are common and appear to be poorly monitored. Our data suggested that improved monitoring of incidental AAAs was independently associated with elective AAA repair. Population-based analyses are required to determine the influence that monitoring has on incidental AAA rupture and patient mortality.

Effect of point-of-care computer reminders on physician behaviour: a systematic review.

BACKGROUND: The opportunity to improve care using computer reminders is one of the main incentives for implementing sophisticated clinical information systems. We conducted a systematic review to quantify the expected magnitude of improvements in processes of care from computer reminders delivered to clinicians during their routine activities. METHODS: We searched the MEDLINE, Embase and CINAHL databases (to July 2008) and scanned the bibliographies of retrieved articles. We included studies in our review if they used a randomized or quasi-randomized design to evaluate improvements in processes or outcomes of care from computer reminders delivered to physicians during routine electronic ordering or charting activities. RESULTS: Among the 28 trials (reporting 32 comparisons) included in our study, we found that computer reminders improved adherence to processes of care by a median of 4.2% (interquartile range [IQR] 0.8%-18.8%). Using the best outcome from each study, we found that the median improvement was 5.6% (IQR 2.0%-19.2%). A minority of studies reported larger effects; however, no study characteristic or reminder feature significantly predicted the magnitude of effect except in one institution, where a well-developed, "homegrown" clinical information system achieved larger improvements than in all other studies (median 16.8% [IQR 8.7%-26.0%] v. 3.0% [IQR 0.5%-11.5%]; p = 0.04). A trend toward larger improvements was seen for reminders that required users to enter a response (median 12.9% [IQR 2.7%-22.8%] v. 2.7% [IQR 0.6%-5.6%]; p = 0.09). INTERPRETATION: Computer reminders produced much smaller improvements than those generally expected from the implementation of computerized order entry and electronic medical record systems. Further research is required to identify features of reminder systems consistently associated with clinically worthwhile improvements.

Study of a multisite prospective adverse event surveillance system.

BACKGROUND: We have designed a prospective adverse event (AE) surveillance method. We performed this study to evaluate this method's performance in several hospitals simultaneously. OBJECTIVES: To compare AE rates obtained by prospective AE surveillance in different hospitals and to evaluate measurement factors explaining observed variation. METHODS: We conducted a multicentre prospective observational study. Prospective AE surveillance was implemented for 8 weeks on the general medicine wards of five hospitals. To determine if population factors may have influenced results, we performed mixed-effects logistic regression. To determine if surveillance factors may have influenced results, we reassigned observers to different hospitals midway through surveillance period and reallocated a random sample of events to different expert review teams. RESULTS: During 3560 patient days of observation of 1159 patient encounters, we identified 356 AEs (AE risk per encounter=22%). AE risk varied between hospitals ranging from 9.9% of encounters in Hospital D to 35.8% of encounters in Hospital A. AE types and severity were similar between hospitals-the most common types were related to clinical procedures (45%), hospital-acquired infections (21%) and medications (19%). Adjusting for age and comorbid status, we observed an association between hospital and AE risk. We observed variation in observer behaviour and moderate agreement between clinical reviewers, which could have influenced the observed rate difference. CONCLUSION: This study demonstrated that it is possible to implement prospective surveillance in different settings. Such surveillance appears to be better suited to evaluating hospital safety concerns within rather than between hospitals as we could not definitively rule out whether the observed variation in AE risk was due to population or surveillance factors.

A modification of the Elixhauser comorbidity measures into a point system for hospital death using administrative data.

BACKGROUND: Comorbidity measures are necessary to describe patient populations and adjust for confounding. In direct comparisons, studies have found the Elixhauser comorbidity system to be statistically slightly superior to the Charlson comorbidity system at adjusting for comorbidity. However, the Elixhauser classification system requires 30 binary variables, making its use for reporting and analysis of comorbidity cumbersome. OBJECTIVE: Modify the Elixhauser classification system into a single numeric score for administrative data. METHODS: For all hospitalizations at the Ottawa Hospital, Canada, between 1996 and 2008, we determined if International Classification of Disease codes for chronic diagnoses were in any of the 30 Elixhauser comorbidity groups. We then used backward stepwise multivariate logistic regression to determine the independent association of each comorbidity group with death in hospital. Regression coefficients were modified into a scoring system that reflected the strength of each comorbidity group's independent association with hospital death. RESULTS: Hospitalizations that were included were 345,795 (derivation: 228,565; validation 117,230). Twenty-one of the 30 groups were independently associated with hospital mortality. The resulting comorbidity score had an equivalent discrimination in the derivation and validation groups (overall c-statistic 0.763, 95% CI: 0.759-0.766). This was similar to models having all Elixhauser groups (0.760, 95% CI: 0.756-0.764) or significant groups only (0.759, 95% CI: 0.754-0.762), but significantly exceeded discrimination when comorbidity was expressed using the Charlson score (0.745, 95% CI: 0.742-0.749). CONCLUSION: When analyzing administrative data, the Elixhauser comorbidity system can be condensed to a single numeric score that summarizes disease burden and is adequately discriminative for death in hospital.

The effects of on-screen, point of care computer reminders on processes and outcomes of care.

BACKGROUND: The opportunity to improve care by delivering decision support to clinicians at the point of care represents one of the main incentives for implementing sophisticated clinical information systems. Previous reviews of computer reminder and decision support systems have reported mixed effects, possibly because they did not distinguish point of care computer reminders from e-mail alerts, computer-generated paper reminders, and other modes of delivering 'computer reminders'. OBJECTIVES: To evaluate the effects on processes and outcomes of care attributable to on-screen computer reminders delivered to clinicians at the point of care. SEARCH STRATEGY: We searched the Cochrane EPOC Group Trials register, MEDLINE, EMBASE and CINAHL and CENTRAL to July 2008, and scanned bibliographies from key articles. SELECTION CRITERIA: Studies of a reminder delivered via a computer system routinely used by clinicians, with a randomised or quasi-randomised design and reporting at least one outcome involving a clinical endpoint or adherence to a recommended process of care. DATA COLLECTION AND ANALYSIS: Two authors independently screened studies for eligibility and abstracted data. For each study, we calculated the median improvement in adherence to target processes of care and also identified the outcome with the largest such improvement. We then calculated the median absolute improvement in process adherence across all studies using both the median outcome from each study and the best outcome. MAIN RESULTS: Twenty-eight studies (reporting a total of thirty-two comparisons) were included. Computer reminders achieved a median improvement in process adherence of 4.2% (interquartile range (IQR): 0.8% to 18.8%) across all reported process outcomes, 3.3% (IQR: 0.5% to 10.6%) for medication ordering, 3.8% (IQR: 0.5% to 6.6%) for vaccinations, and 3.8% (IQR: 0.4% to 16.3%) for test ordering. In a sensitivity analysis using the best outcome from each study, the median improvement was 5.6% (IQR: 2.0% to 19.2%) across all process measures and 6.2% (IQR: 3.0% to 28.0%) across measures of medication ordering. In the eight comparisons that reported dichotomous clinical endpoints, intervention patients experienced a median absolute improvement of 2.5% (IQR: 1.3% to 4.2%). Blood pressure was the most commonly reported clinical endpoint, with intervention patients experiencing a median reduction in their systolic blood pressure of 1.0 mmHg (IQR: 2.3 mmHg reduction to 2.0 mmHg increase). AUTHORS' CONCLUSIONS: Point of care computer reminders generally achieve small to modest improvements in provider behaviour. A minority of interventions showed larger effects, but no specific reminder or contextual features were significantly associated with effect magnitude. Further research must identify design features and contextual factors consistently associated with larger improvements in provider behaviour if computer reminders are to succeed on more than a trial and error basis.

Anticoagulation intensity and outcomes among patients prescribed oral anticoagulant therapy: a systematic review and meta-analysis.

BACKGROUND: Patients taking oral anticoagulant therapy balance the risks of hemorrhage and thromboembolism. We sought to determine the association between anticoagulation intensity and the risk of hemorrhagic and thromboembolic events. We also sought to determine how under-or overanticoagulation would influence patient outcomes. METHODS: We reviewed the MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials and CINAHL databases to identify studies involving patients taking anticoagulants that reported person-years of observation and the number of hemorrhages or thromboemboli in 3 or more discrete ranges of international normalized ratios. We estimated the overall relative and absolute risks of events specific to anticoagulation intensity. RESULTS: We included 19 studies. The risk of hemorrhage increased significantly at high international normalized ratios. Compared with the therapeutic ratio of 2-3, the relative risk (RR) of hemorrhage (and 95% confidence intervals [CIs]) were 2.7 (1.8-3.9; p < 0.01) at a ratio of 3-5 and 21.8 (12.1-39.4; p < 0.01) at a ratio greater than 5. The risk of thromboemboli increased significantly at ratios less than 2, with a relative risk of 3.5 (95% CI 2.8-4.4; p < 0.01). The risk of hemorrhagic or thromboembolic events was lower at ratios of 3-5 (RR 1.8, 95% CI 1.2-2.6) than at ratios of less than 2 (RR 2.4, 95% CI 1.9-3.1; p = 0.10). We found that a ratio of 2-3 had the lowest absolute risk (AR) of events (AR 4.3%/yr, 95% CI 3.0%-6.3%). CONCLUSIONS: The risks of hemorrhage and thromboemboli are minimized at international normalized ratios of 2-3. Ratios that are moderately higher than this therapeutic range appear safe and more effective than subtherapeutic ratios.

Effects of aerobic training, resistance training, or both on glycemic control in type 2 diabetes: a randomized trial.

BACKGROUND: Previous trials have evaluated the effects of aerobic training alone and of resistance training alone on glycemic control in type 2 diabetes, as assessed by hemoglobin A1c values. However, none could assess incremental effects of combined aerobic and resistance training compared with either type of exercise alone. OBJECTIVE: To determine the effects of aerobic training alone, resistance training alone, and combined exercise training on hemoglobin A1c values in patients with type 2 diabetes. DESIGN: Randomized, controlled trial. SETTING: 8 community-based facilities. PATIENTS: 251 adults age 39 to 70 years with type 2 diabetes. A negative result on a stress test or clearance by a cardiologist, and adherence to exercise during a 4-week run-in period, were required before randomization. INTERVENTIONS: Aerobic training, resistance training, or both types of exercise (combined exercise training). A sedentary control group was included. Exercise training was performed 3 times weekly for 22 weeks (weeks 5 to 26 of the study). MEASUREMENTS: The primary outcome was the change in hemoglobin A1c value at 6 months. Secondary outcomes were changes in body composition, plasma lipid values, and blood pressure. RESULTS: The absolute change in the hemoglobin A1c value in the combined exercise training group compared with the control group was -0.51 percentage point (95% CI, -0.87 to -0.14) in the aerobic training group and -0.38 percentage point (CI, -0.72 to -0.22) in the resistance training group. Combined exercise training resulted in an additional change in the hemoglobin A1c value of -0.46 percentage point (CI, -0.83 to -0.09) compared with aerobic training alone and -0.59 percentage point (CI, -0.95 to -0.23) compared with resistance training alone. Changes in blood pressure and lipid values did not statistically significantly differ among groups. Adverse events were more common in the exercise groups. LIMITATIONS: The generalizability of the results to patients who are less adherent to exercise programs is uncertain. The participants were not blinded, and the total duration of exercise was greater in the combined exercise training group than in the aerobic and resistance training groups. CONCLUSION: Either aerobic or resistance training alone improves glycemic control in type 2 diabetes, but the improvements are greatest with combined aerobic and resistance training. ClinicalTrials.gov registration number: NCT00195884.

Effect of study setting on anticoagulation control: a systematic review and metaregression.

BACKGROUND: For patients receiving therapy with oral anticoagulants (OACs), the proportion of time spent in the therapeutic range (ie, anticoagulation control) is strongly associated with bleeding and thromboembolic risk. The effect of study-level factors, especially study setting, on anticoagulation control is unknown. OBJECTIVES: Describe anticoagulation control achieved in the published literature. We also used metaregressive techniques to determine which study-level factors significantly influenced anticoagulation control. STUDIES: All published randomized or cohort studies that measured international normalized ratios (INRs) serially in anticoagulated patients and reported the proportion of time between INRs ranging from 1.8 to 2.0 and 3.0 to 3.5. RESULTS: We identified 67 studies with 123 patient groups having 50,208 patients followed for a total of 57,154.7 patient-years. A total of 68.3% of groups were from anticoagulation clinics, 7.3% were from clinical trials, and 24.4% were from community practices. Overall, patients were therapeutic 63.6% of time (95% confidence interval [CI], 61.6 to 65.6). In the metaregression model, study setting had the greatest effect on anticoagulation control with studies in community practices having significantly lower control than either anticoagulation clinics or clinical trials (-12.2%; 95% CI, -19.5 to -4.8; p < 0.0001). Self-management was associated with a significant improvement of time spent in the therapeutic range (+7.0%; 95% CI, 0.7 to 13.3; p = 0.03). CONCLUSIONS: Patients who have received anticoagulation therapy spend a significant proportion of their time with an INR out of the therapeutic range. Patients from community practices showed significantly worse anticoagulation control than those from anticoagulation clinics or clinical trials. This should be considered when interpreting the results of, and generalizing from, studies involving OACs.

Oligodendrocyte Lineage Cells in Chronic Demyelination of Multiple Sclerosis Optic Nerve.

Reports that chronically demyelinated multiple sclerosis brain and spinal cord lesions contained immature oligodendrocyte lineage cells have generated major interest aimed at the potential for promotion of endogenous repair. Despite the prominence of the optic nerve as a lesion site and its importance in clinical disease assessment, no detailed studies of multiple sclerosis-affected optic nerve exist. This study aims to provide insight into the cellular pathology of chronic demyelination in multiple sclerosis through direct morphological and immunohistochemical analysis of optic nerve in conjunction with observations from an experimental cat optic nerve model of successful remyelination. Myelin staining was followed by immunohistochemistry to differentially label neuroglia. Digitally immortalized sections were then analyzed to generate quantification data and antigenic phenotypes including maturational stages within the oligodendrocyte lineage. It was found that some chronically demyelinated multiple sclerosis optic nerve lesions contained oligodendroglial cells and that heterogeneity existed in the presence of myelin sheaths, oligodendrocyte maturational stages and extent of axonal investment. The findings advance our understanding of oligodendrocyte activity in chronically demyelinated human optic nerve and may have implications for studies aimed at enhancement of endogenous repair in multiple sclerosis.

Effectiveness of a computerized drug-monitoring program to detect and prevent adverse drug events and medication non-adherence in outpatient ambulatory care: study protocol of a randomized controlled trial.

BACKGROUND: Medications are an effective intervention for managing and preventing health problems but their benefit can be undermined by non-adherence or adverse drug events (ADEs). Since these issues may be interconnected, efforts to improve non-adherence should also include reduction of ADEs. We have developed the ISTOP-ADE system (Information Systems-enabled Outreach for Preventing Adverse Drug Events), which enables timely monitoring and managing of ADEs. The objectives of this study are to determine whether the ISTOP-ADE system, compared to routine care, will reduce: a) the probability of discontinuing the use of prognosis-altering medications; b) the probability of a patient experiencing a severe ADE; c) the proportion of patients experiencing ADEs, preventable ADEs and ameliorable ADEs; and d) health services utilization. METHODS/DESIGN: We will randomly assign 2,200 adult ambulatory patients in the province of Québec who have been prescribed an incident medication for the management or prevention of a chronic health condition, to routine care or the ISTOP-ADE system. The ISTOP-ADE system consists of an interactive voice response system (IVRS) paired with pharmacist support. The IVRS will call patients at 3 and 17 days post-prescription to determine if they are experiencing any problems and connect them with a pharmacist when required or desired by the patient. We will evaluate medication persistence at 180 days and health-care utilization using provincial administrative data. Two blinded physicians will ascertain ADE status through a case review. DISCUSSION: We expect the ISTOP-ADE intervention to be feasible and to improve the quality of patient care through improved medication adherence, reduced ADE duration and reduced number of ADEs resulting in an emergency department or inpatient encounter. This in turn could lower health-care utilization, saving costs and lowering the burden on emergency departments and family practices. The success of ISTOP-ADE would present opportunities to implement this intervention through health systems, health insurance agents and commercial pharmacies. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02059044. Date registered: 10 January 2014.