Person: Normand, Sharon-Lise
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Publication Evaluation of an Automated Safety Surveillance System Using Risk Adjusted Sequential Probability Ratio Testing
(BioMed Central, 2011) Matheny, Michael E; Normand, Sharon-Lise; Gross, Thomas; Marinac-Dabic, Danica; Loyo-Berrios, Nilsa; Vidi, Venkatesan D; Donnelly, Sharon; Resnic, Frederic S.Background: Automated adverse outcome surveillance tools and methods have potential utility in quality improvement and medical product surveillance activities. Their use for assessing hospital performance on the basis of patient outcomes has received little attention. We compared risk-adjusted sequential probability ratio testing (RA-SPRT) implemented in an automated tool to Massachusetts public reports of 30-day mortality after isolated coronary artery bypass graft surgery. Methods A total of 23,020 isolated adult coronary artery bypass surgery admissions performed in Massachusetts hospitals between January 1, 2002 and September 30, 2007 were retrospectively re-evaluated. The RA-SPRT method was implemented within an automated surveillance tool to identify hospital outliers in yearly increments. We used an overall type I error rate of 0.05, an overall type II error rate of 0.10, and a threshold that signaled if the odds of dying 30-days after surgery was at least twice than expected. Annual hospital outlier status, based on the state-reported classification, was considered the gold standard. An event was defined as at least one occurrence of a higher-than-expected hospital mortality rate during a given year. Results: We examined a total of 83 hospital-year observations. The RA-SPRT method alerted 6 events among three hospitals for 30-day mortality compared with 5 events among two hospitals using the state public reports, yielding a sensitivity of 100% (5/5) and specificity of 98.8% (79/80). Conclusions: The automated RA-SPRT method performed well, detecting all of the true institutional outliers with a small false positive alerting rate. Such a system could provide confidential automated notification to local institutions in advance of public reporting providing opportunities for earlier quality improvement interventions.
Publication Protocol for the China PEACE (Patient-centered Evaluative Assessment of Cardiac Events) retrospective study of coronary catheterisation and percutaneous coronary intervention
(BMJ Publishing Group, 2014) Li, Jing; Dharmarajan, Kumar; Li, Xi; Lin, Zhenqiu; Normand, Sharon-Lise; Krumholz, Harlan M; Jiang, LixinIntroduction: During the past decade, the volume of percutaneous coronary intervention (PCI) in China has risen by more than 20-fold. Yet little is known about patterns of care and outcomes across hospitals, regions and time during this period of rising cardiovascular disease and dynamic change in the Chinese healthcare system. Methods and analysis Using the China PEACE (Patient-centered Evaluative Assessment of Cardiac Events) research network, the Retrospective Study of Coronary Catheterisation and Percutaneous Coronary Intervention (China PEACE-Retrospective CathPCI Study) will examine a nationally representative sample of 11 900 patients who underwent coronary catheterisation or PCI at 55 Chinese hospitals during 2001, 2006 and 2011. We selected patients and study sites using a two-stage cluster sampling design with simple random sampling stratified within economical-geographical strata. A central coordinating centre will monitor data quality at the stages of case ascertainment, medical record abstraction and data management. We will examine patient characteristics, diagnostic testing patterns, procedural treatments and in-hospital outcomes, including death, complications of treatment and costs of hospitalisation. We will additionally characterise variation in treatments and outcomes by patient characteristics, hospital, region and study year. Ethics and dissemination The China PEACE collaboration is designed to translate research into improved care for patients. The study protocol was approved by the central ethics committee at the China National Center for Cardiovascular Diseases (NCCD) and collaborating hospitals. Findings will be shared with participating hospitals, policymakers and the academic community to promote quality monitoring, quality improvement and the efficient allocation and use of coronary catheterisation and PCI in China. Registration details http://www.clinicaltrials.gov (NCT01624896).
Publication Impact of adverse events on prescribing warfarin in patients with atrial fibrillation: matched pair analysis
(BMJ, 2006) Choudhry, Niteesh; Anderson, Geoffrey M.; Laupacis, Andreas; Ross-Degnan, Dennis; Normand, Sharon-Lise; Soumerai, StephenObjectives To quantify the influence of physicians' experiences of adverse events in patients with atrial fibrillation who were taking warfarin.
Design Population based, matched pair before and after analysis.
Setting Database study in Ontario, Canada.
Participants The physicians of patients with atrial fibrillation admitted to hospital for adverse events (major haemorrhage while taking warfarin and thromboembolic strokes while not taking warfarin). Pairs of other patients with atrial fibrillation treated by the same physicians were selected.
Main outcome measures Odds of receiving warfarin by matched pairs of a given physician's patients (one treated after and one treated before the event) were compared, with adjustment for stroke and bleeding risk factors that might also influence warfarin use. The odds of prescriptions for angiotensin converting enzyme (ACE) inhibitor before and after the event was assessed as a neutral control.
Results For the 530 physicians who had a patient with an adverse bleeding event (exposure) and who treated other patients with atrial fibrillation during the 90 days before and the 90 days after the exposure, the odds of prescribing warfarin was 21% lower for patients after the exposure (adjusted odds ratio 0.79, 95% confidence interval 0.62 to 1.00). Greater reductions in warfarin prescribing were found in analyses with patients for whom more time had elapsed between the physician's exposure and the patient's treatment. There were no significant changes in warfarin prescribing after a physician had a patient who had a stroke while not on warfarin or in the prescribing of ACE inhibitors by physicians who had patients with either bleeding events or strokes.
Conclusions A physician's experience with bleeding events associated with warfarin can influence prescribing warfarin. Adverse events that are possibly associated with underuse of warfarin may not affect subsequent prescribing.
Publication Socioeconomic Background and Commercial Health Plan Spending
(American Academy of Pediatrics (AAP), 2017) Chien, Alyna; Newhouse, Joseph; Iezzoni, Lisa; Petty, Carter R.; Normand, Sharon-Lise; Schuster, MarkBACKGROUND: Risk-adjustment algorithms typically incorporate demographic and clinical variables to equalize compensation to insurers for enrollees who vary in expected cost, but including information about enrollees’ socioeconomic background is controversial.
METHODS: We studied 1 182 847 continuously insured 0 to 19-year-olds using 2008–2012 Blue Cross Blue Shield of Massachusetts and American Community Survey data. We characterized enrollees’ socioeconomic background using the validated area-based socioeconomic measure and calculated annual plan payments using paid claims. We evaluated the relationship between annual plan payments and geocoded socioeconomic background using generalized estimating equations (γ distribution and log link). We expressed outcomes as the percentage difference in spending and utilization between enrollees with high and low socioeconomic backgrounds.
RESULTS: Geocoded socioeconomic background had a significant, positive association with annual plan payments after applying standard adjusters. Every 1 SD increase in socioeconomic background was associated with a 7.8% (95% confidence interval, 7.2% to 8.3%; P < .001) increase in spending. High socioeconomic background enrollees used higher-priced outpatient and pharmacy services more frequently than their counterparts from low socioeconomic backgrounds (eg, 25% more outpatient encounters annually; 8% higher price per encounter; P < .001), which outweighed greater emergency department spending among low socioeconomic background enrollees.
CONCLUSIONS: Higher socioeconomic background is associated with greater levels of pediatric health care spending in commercially insured children. Including socioeconomic information in risk-adjustment algorithms may address concerns about adverse selection from an economic perspective, but it would direct funds away from those caring for children and adolescents from lower socioeconomic backgrounds who are at greater risk of poor health.
Publication Hospice Use Following Implantable Cardioverter-Defibrillator Implantation in Older Patients: Results From the National Cardiovascular Data Registry
(Lippincott Williams & Wilkins, 2016) Kramer, Daniel; Reynolds, Matthew R.; Normand, Sharon-Lise; Parzynski, Craig S.; Spertus, John A.; Mor, Vincent; Mitchell, SusanBackground— Older recipients of implantable cardioverter-defibrillators (ICDs) are at increased risk for short-term mortality in comparison with younger patients. Although hospice use is common among decedents aged >65, its use among older ICD recipients is unknown. Methods and Results— Medicare patients aged >65 matched to data in the National Cardiovascular Data Registry – ICD Registry from January 1, 2006 to March 31, 2010 were eligible for analysis (N=194 969). The proportion of ICD recipients enrolled in hospice, cumulative incidence of hospice admission, and factors associated with time to hospice enrollment were evaluated. Five years after device implantation, 50.9% of patients were either deceased or in hospice. Among decedents, 36.8% received hospice services. The cumulative incidence of hospice enrollment, accounting for the competing risk of death, was 4.7% (95% confidence interval [CI], 4.6%–4.8%) within 1 year and 21.3% (95% CI, 20.7%–21.8%) at 5 years. Factors most strongly associated with shorter time to hospice enrollment were older age (adjusted hazard ratio, 1.77; 95% CI, 1.73–1.81), class IV heart failure (versus class I; adjusted hazard ratio, 1.79; 95% CI, 1.66–1.94); ejection fraction <20 (adjusted hazard ratio, 1.57; 95% CI, 1.48–1.67), and greater hospice use among decedents in the patients’ health referral region. Conclusions— More than one-third of older patients dying with ICDs receive hospice care. Five years after implantation, half of older ICD recipients are either dead or in hospice. Hospice providers should be prepared for ICD patients, whose clinical trajectories and broader palliative care needs require greater focus.
Publication Developing an African youth psychosocial assessment: an application of item response theory
(Wiley-Blackwell, 2014) Betancourt, Theresa; Yang, Frances Margaret; Bolton, Paul; Normand, Sharon-LiseThis study aimed to refine a dimensional scale for measuring psychosocial adjustment in African youth using item response theory (IRT). A 60-item scale derived from qualitative data was administered to 667 war-affected adolescents (55% female). Exploratory factor analysis (EFA) determined the dimensionality of items based on goodness-of-fit indices. Items with loadings less than 0.4 were dropped. Confirmatory factor analysis (CFA) was used to confirm the scale's dimensionality found under the EFA. Item discrimination and difficulty were estimated using a graded response model for each subscale using weighted least squares means and variances. Predictive validity was examined through correlations between IRT scores (θ) for each subscale and ratings of functional impairment. All models were assessed using goodness-of-fit and comparative fit indices. Fisher's Information curves examined item precision at different underlying ranges of each trait. Original scale items were optimized and reconfigured into an empirically-robust 41-item scale, the African Youth Psychosocial Assessment (AYPA). Refined subscales assess internalizing and externalizing problems, prosocial attitudes/behaviors and somatic complaints without medical cause. The AYPA is a refined dimensional assessment of emotional and behavioral problems in African youth with good psychometric properties. Validation studies in other cultures are recommended.
Publication Patient Activity and Survival Following Implantable Cardioverter-Defibrillator Implantation: The ALTITUDE Activity Study
(John Wiley & Sons, Ltd, 2015) Kramer, Daniel; Mitchell, Susan; Monteiro, Joao; Jones, Paul W; Normand, Sharon-Lise; Hayes, David L; Reynolds, Matthew RBackground: Physical activity data are collected automatically by implantable cardioverter-defibrillators (ICDs). Though these data potentially provide a quantifiable and easily accessible measure of functional status, its relationship with survival has not been well studied. Methods and Results: Patients enrolled in the Boston Scientific LATITUDE remote monitoring system from 2008 to 2012 with ICDs were eligible. Remote monitoring data were used to calculate mean daily activity at baseline (30 to 60 days after implantation), and longitudinally. Cox regression was used to examine the association between survival and increments of 30 minutes/day in both (1) mean baseline activity and (2) time-varying activity, with both adjusted for demographic and device characteristics. A total of 98 437 patients were followed for a median of 2.2 years (mean age of 67.7±13.1 years; 71.7% male). Mean baseline daily activity was 107.5±66.2 minutes/day. The proportion of patients surviving after 4 years was significantly higher among those in the most versus least active quintile of mean baseline activity (90.5% vs. 50.0%; log-rank P value, <0.001). Lower mean baseline activity (i.e., incremental difference of 30-minutes/day) was independently associated with a higher risk of death (adjusted hazard ratio [AHR], 1.44; 95% confidence interval [CI], 1.427 to 1.462). Time-varying activity was similarly associated with a higher risk of death (AHR, 1.48; 95% CI, 1.451 to 1.508), indicating that a patient having 30 minutes per day less activity in a given month has a 48% increased hazard for death when compared to a similar patient in the same month. Conclusions: Patient activity measured by ICDs strongly correlates with survival following ICD implantation.
Publication Study protocol for a cluster randomised controlled trial to assess the effectiveness of user-driven intervention to prevent aggressive events in psychiatric services
(BioMed Central, 2017) Välimäki, Maritta; Yang, Min; Normand, Sharon-Lise; Lorig, Kate R.; Anttila, Minna; Lantta, Tella; Pekurinen, Virve; Adams, Clive E.Background: People admitted to psychiatric hospitals with a diagnosis of schizophrenia may display behavioural problems. These may require management approaches such as use of coercive practices, which impact the well-being of staff members, visiting families and friends, peers, as well as patients themselves. Studies have proposed that not only patients’ conditions, but also treatment environment and ward culture may affect patients’ behaviour. Seclusion and restraint could possibly be prevented with staff education about user-centred, more humane approaches. Staff education could also increase collaboration between patients, family members and staff, which may further positively affect treatment culture and lower the need for using coercive treatment methods. Methods: This is a single-blind, two-arm cluster randomised controlled trial involving 28 psychiatric hospital wards across Finland. Units will be randomised to receive either a staff educational programme delivered by the team of researchers, or standard care. The primary outcome is the incidence of use of patient seclusion rooms, assessed from the local/national health registers. Secondary outcomes include use of other coercive methods (limb restraint, forced injection, and physical restraint), service use, treatment satisfaction, general functioning among patients, and team climate and employee turn-over (nursing staff). Discussion The study, designed in close collaboration with staff members, patients and their relatives, will provide evidence for a co-operative and user-centred educational intervention aiming to decrease the prevalence of coercive methods and service use in the units, increase the functional status of patients and improve team climate in the units. We have identified no similar trials. Trial registration ClinicalTrials.gov NCT02724748. Registered on 25th of April 2016.
Publication Identifying Medicare beneficiaries with dementia
(Wiley, 2021-04-26) Moura, Lidia M. V. R.; Festa, Natalia; Price, Mary; Volya, Margarita; Benson, Nicole M.; Zafar, Sahar; Weiss, Max; Blacker, Deborah; Normand, Sharon-Lise; Newhouse, Joseph; Hsu, JohnBACKGROUND/OBJECTIVES: No data exist regarding the validity of International Classification of Disease (ICD)-10 dementia diagnoses within Medicare claims data. We examined the accuracy of claims-based diagnoses with respect to expert clinician adjudication using a novel database with individual-level linkages between electronic health record (EHR) and claims. DESIGN: In this retrospective observational study, two neurologists and two psychiatrists performed a standardized review of patients’ medical records from January-2016 to December-2018, and adjudicated dementia status. We measured the accuracy of three claims-based definitions of dementia against the reference standard. SETTING: Mass-General-Brigham Healthcare (MGB), Massachusetts, USA. PARTICIPANTS: From an eligible population of 40,690 fee-for-service (FFS) Medicare beneficiaries, aged 65-years and older, within the MGB Accountable Care Organization (ACO), we generated a random sample of 1,002 patients, stratified by the pretest likelihood of dementia using administrative surrogates. INTERVENTION: None. MEASUREMENTS: We evaluated the accuracy (area-under-receiver-operating-curve [AUROC]) and calibration (calibration-in-the-large [CITL] and calibration slope) of three ICD-10 claims-based definitions of dementia against clinician-adjudicated standards. We applied inverse probability weighting to reconstruct the eligible population and reported the mean and 95% confidence interval (95% CI) for all performance characteristics, using 10-fold cross-validation (CV). RESULTS: Beneficiaries had an average age of 75.3-years and were predominately female (59%) and non-Hispanic white (93%). The adjudicated prevalence of dementia in the eligible population was 7%. The best performing definition demonstrated excellent accuracy (CV-AUC 0.94; 95% CI 0.92-0.96) and was well-calibrated to the reference standard of clinician-adjudicated dementia (CV-CITL <0.001, CV-slope 0.97). CONCLUSION: This study is the first to validate ICD-10 diagnostic codes against a robust and replicable approach to dementia ascertainment using a real-world clinical reference standard. The best performing definition includes diagnostic codes with strong face validity and outperforms an updated version of a previously validated ICD-9 definition of dementia.
Publication Trajectories of risk after hospitalization for heart failure, acute myocardial infarction, or pneumonia: retrospective cohort study
(BMJ Publishing Group Ltd., 2015) Dharmarajan, Kumar; Hsieh, Angela F; Kulkarni, Vivek T; Lin, Zhenqiu; Ross, Joseph S; Horwitz, Leora I; Kim, Nancy; Suter, Lisa G; Lin, Haiqun; Normand, Sharon-Lise; Krumholz, Harlan MObjective: To characterize the absolute risks for older patients of readmission to hospital and death in the year after hospitalization for heart failure, acute myocardial infarction, or pneumonia. Design: Retrospective cohort study. Setting: 4767 hospitals caring for Medicare fee for service beneficiaries in the United States, 2008-10. Participants: More than 3 million Medicare fee for service beneficiaries, aged 65 years or more, surviving hospitalization for heart failure, acute myocardial infarction, or pneumonia. Main outcome measures Daily absolute risks of first readmission to hospital and death for one year after discharge. To illustrate risk trajectories, we identified the time required for risks of readmission to hospital and death to decline 50% from maximum values after discharge; the time required for risks to approach plateau periods of minimal day to day change, defined as 95% reductions in daily changes in risk from maximum daily declines after discharge; and the extent to which risks are higher among patients recently discharged from hospital compared with the general elderly population. Results: Within one year of hospital discharge, readmission to hospital and death, respectively, occurred following 67.4% and 35.8% of hospitalizations for heart failure, 49.9% and 25.1% for acute myocardial infarction, and 55.6% and 31.1% for pneumonia. Risk of first readmission had declined 50% by day 38 after hospitalization for heart failure, day 13 after hospitalization for acute myocardial infarction, and day 25 after hospitalization for pneumonia; risk of death declined 50% by day 11, 6, and 10, respectively. Daily change in risk of first readmission to hospital declined 95% by day 45, 38, and 45; daily change in risk of death declined 95% by day 21, 19, and 21. After hospitalization for heart failure, acute myocardial infarction, or pneumonia, the magnitude of the relative risk for hospital admission over the first 90 days was 8, 6, and 6 times greater than that of the general older population; the relative risk of death was 11, 8, and 10 times greater. Conclusions: Risk declines slowly for older patients after hospitalization for heart failure, acute myocardial infarction, or pneumonia and is increased for months. Specific risk trajectories vary by discharge diagnosis and outcome. Patients should remain vigilant for deterioration in health for an extended time after discharge. Health providers can use knowledge of absolute risks and their changes over time to better align interventions designed to reduce adverse outcomes after discharge with the highest risk periods for patients.