Cost-utility analysis of community-based interventions for hypertension control in Vietnam.

Between 2010 and 2011, stakeholders implemented a multi-faceted community-based intervention in response to the escalating issue of uncontrolled hypertension in Hung Yen province, Vietnam. This initiative integrated expanded community health worker services, home blood pressure self-monitoring, and a unique "storytelling intervention" into routine clinical care. From the limited societal perspective, our study evaluates the cost-effectiveness of this intervention using a Markov model with a one-year cycle over a lifetime horizon. The analysis, based on a cohort of 671 patients, reveals a lifetime incremental cost of approximately VND 90.37 million (USD 3,930) per quality-adjusted life year (QALY) gained. With a willingness to pay at three times GDP (VND 259.2 million per QALY), the intervention proves cost-effective 80% of the time. This research underscores the potential of the community-based approach to effectively control hypertension, offering valuable insights into its broader implications for public health.

Understanding US Physician and Pharmacist Attitudes Toward Biosimilar Products: A Qualitative Study.

BACKGROUND: Biosimilars account for 30-40% of biologic medications dispensed in the United States (US), yet healthcare providers in relevant medical specialties have limited awareness of biosimilars and their characteristics. Likewise, many providers perceive biosimilars as less safe and effective than original biologics and are more comfortable prescribing original biologics to patients. METHODS: We conducted in-person focus groups at three clinical sites in California and Texas (n = 49) to explore the reasons behind US healthcare providers' limited understanding of, cautious attitudes toward, and reluctance to prescribe biosimilars. We conducted thematic analysis by having three researchers independently analyze verbatim transcripts and identify patterns in provider responses. RESULTS: Providers' limited knowledge of and cautious attitudes toward biosimilars are driven by uncertainty about how biosimilarity is defined and operationalized as well as negative past experiences with generic drugs that did not perform as well as branded counterparts. Additionally, healthcare providers are unfamiliar with the Food and Drug Administration's (FDA's) approval pathway for biosimilars and are skeptical that an abbreviated approval process is rigorous enough to ensure biosimilars deliver the same efficacy and have the same side effect profiles as original biologics. Physicians also expressed concerns about pharmacy substitution of biosimilars and interchangeables, explaining they would be unaware of which medication was ultimately given to their patients. CONCLUSIONS: Educating physicians and pharmacists about biosimilars-including how biosimilarity is defined and operationalized, the structure of the biosimilar approval process, and how analytical data can ensure biosimilar safety and efficacy-will be important for reducing healthcare providers' concerns and increasing biosimilar adoption in the US.

How much can we trust electronic health record data?

Trust in EHR data is becoming increasingly important as a greater share of clinical and health services research use EHR data. We discuss reasons for distrust and acknowledge limitations. Researchers continue to use EHR data because of strengths including greater clinical detail than sources like administrative billing claims. Further, many limitations are addressable with existing methods including data quality checks and common data frameworks. We discuss how to build greater trust in the use of EHR data for research, including additional transparency and research priority areas that will both enhance existing strengths of the EHR and mitigate its limitations.

Offsetting Patient-Centered Medical Homes Investment Costs Through Per-Member-Per-Month or Medicare Merit-based Incentive Payment System Incentive Payments.

Primary care practices become patient-centered medical homes (PCMHs) to improve care. However, investment costs and opportunities to offset those costs are critical to the decision. We examined potential offsets through commercial payer per-member-per-month (PMPM) payments and the Medicare Merit-based Incentive Payment System (MIPS) for a network that spent $4 818 260 over 4 years obtaining and renewing PCMH recognition for 57 practices. With PMPM payments of $3.37 to $8.98, "breakeven" requires that 2.4% to 6.4% of the network's 1645 commercially insured patients per physician be covered, while applying MIPS incentive payments of half the maximum available each year to the network's average 2016 Medicare reimbursement of $196 812 per physician showed they would exceed PCMH costs by 2022.

Costs of Transforming Established Primary Care Practices to Patient-Centered Medical Homes (PCMHs).

BACKGROUND: The patient-centered medical home (PCMH) shows promise for improving care and reducing costs. We sought to reduce the uncertainty regarding the time and cost of PCMH transformation by quantifying the direct costs of transforming 57 practices in a medical group to National Committee for Quality Assurance (NCQA)-recognized Level III PCMHs. METHODS: We conducted structured interviews with corporate leaders, and with physicians, practice administrators, and office managers from a representative sample of practices regarding time spent on PCMH transformation and NCQA application, and related purchases. We then developed and sent a survey to all primary care practices (practice-level response rate: initial recognition-44.6%, renewal-35.7%). Direct costs were estimated as time spent multiplied by average hourly wage for the relevant job category, plus observed expenditures. RESULTS: We estimated HealthTexas' corporate costs for initial NCQA recognition (2010-2012) at $1,508,503; for renewal (2014-2016), $346,617; the Care Coordination resource costs an additional ongoing $390,790/year. A hypothetical 5-physician HealthTexas practice spent another estimated 239.5 hours ($10,669) obtaining, and 110.5 hours ($4,957) renewing, recognition. CONCLUSION: Centralized PCMH support reduces the burden on practices; however, overall time and cost remains substantial, and should be weighed against the mixed evidence regarding PCMH's impact on quality and costs of care.

Improving diabetes care and outcomes with community health workers.

BACKGROUND: Type II diabetes continues to be a major health problem in USA, particularly in minority populations. The Diabetes Equity Project (DEP), a clinic-based diabetes self-management and education program led by community health workers (CHWs), was designed to reduce observed disparities in diabetes care and outcomes in medically underserved, predominantly Hispanic communities. OBJECTIVE: The purpose of this study was to evaluate the impact of the DEP on patients' clinical outcomes, diabetes knowledge, self-management skills, and quality of life. METHODS: The DEP was implemented in five community clinics from 2009 to 2013 and 885 patients completed at least two visits with the CHW. Student's paired t-tests were used to compare baseline clinical indicators with indicators obtained from patients' last recorded visit with the CHW and to assess differences in diabetes knowledge, perceived competence in managing diabetes, and quality of life. A mixed-effects model for repeated measures was used to examine the effect of DEP visits on blood glucose (HbA1c), controlling for patient demographics, clinic and enrolment date. RESULTS: DEP patients experienced significant (P < 0.0001) improvements in HbA1c control, blood pressure, diabetes knowledge, perceived competence in managing diabetes, and quality of life. Mean HbA1c for all DEP patients decreased from 8.3% to 7.4%. CONCLUSION: Given the increasing prevalence of diabetes in USA and documented disparities in diabetes care and outcomes for minorities, particularly Hispanic patients, new models of care such as the DEP are needed to expand access to and improve the delivery of diabetes care and help patients achieve improved outcomes.

The impact of electronic health records on workflow and financial measures in primary care practices.

OBJECTIVE: To estimate a commercially available ambulatory electronic health record's (EHR's) impact on workflow and financial measures. DATA SOURCES/STUDY SETTING: Administrative, payroll, and billing data were collected for 26 primary care practices in a fee-for-service network that rolled out an EHR on a staggered schedule from June 2006 through December 2008. STUDY DESIGN: An interrupted time series design was used. Staffing, visit intensity, productivity, volume, practice expense, payments received, and net income data were collected monthly for 2004-2009. Changes were evaluated 1-6, 7-12, and >12 months postimplementation. DATA COLLECTION/EXTRACTION METHODS: Data were accessed through a SQLserver database, transformed into SAS®, and aggregated by practice. Practice-level data were divided by full-time physician equivalents for comparisons across practices by month. PRINCIPAL FINDINGS: Staffing and practice expenses increased following EHR implementation (3 and 6 percent after 12 months). Productivity, volume, and net income decreased initially but recovered to/close to preimplementation levels after 12 months. Visit intensity did not change significantly, and a secular trend offset the decrease in payments received. CONCLUSIONS: Expenses increased and productivity decreased following EHR implementation, but not as much or as persistently as might be expected. Longer term effects still need to be examined.

Analysis of the direct cost of surgery for four diagnostic categories of adult spinal deformity.

BACKGROUND CONTEXT: Existing literature on adult spinal deformity (ASD) offers little guidance regarding an evidence-based approach to care. To optimize the value of medical treatment, a thorough understanding of the cost of surgical treatment for ASD is required. PURPOSE: To evaluate four clinically and radiographically distinct groups of ASD and identify and compare the cost of surgical treatment among the groups. STUDY DESIGN/SETTING: Multicenter retrospective study of consecutive surgeries for ASD. PATIENT SAMPLE: Three hundred twenty-five consecutive ASD patients treated between 2008 and 2010. OUTCOME MEASURES: Cost data were collected from hospital administrative records on the direct costs (DCs) incurred for the episode of surgical care, excluding overhead. METHODS: Based on preoperative radiographs and history, patients were categorized into one of four diagnostic categories of deformity: primary idiopathic scoliosis (PIS), primary degenerative scoliosis (PDS), primary sagittal plane deformity (PSPD), and revision (R). Analysis of variance and generalized linear model regressions were used to analyze the DCs of surgery and to assess differences in costs across the four diagnostic categories considered. RESULTS: Significant differences were observed in DC of surgery for different categories of ASD, with surgical treatment for PDS the most expensive followed in decreasing order by PSPD, PIS, and R (p<.01). Results further revealed a significant positive relationship between age and DC (p<.01) and a significant positive relationship between length of stay and DC (p<.01). Among PIS patients, for every incremental increase in levels fused, the expected DC increased by $3,997 (p=.00). Fusion to pelvis also significantly increased the DC of surgery for patients aged 18 to 29 years (p<.01) and 30 to 59 years (p<.01) but not for 60 years or more (p=.86). CONCLUSIONS: There is an increasing DC of surgery with increasing age, length of hospital stay, length of fusion, and fusions to the pelvis. Revision surgery is the least expensive surgery on average and should therefore not preclude its consideration from a pure cost perspective.

Challenges in using electronic health record data for CER: experience of 4 learning organizations and solutions applied.

OBJECTIVE: To document the strengths and challenges of using electronic health records (EHRs) for comparative effectiveness research (CER). METHODS: A replicated case study of comparative effectiveness in hypertension treatment was conducted across 4 health systems, with instructions to extract data and document problems encountered using a specified list of required data elements. Researchers at each health system documented successes and challenges, and suggested solutions for addressing challenges. RESULTS: Data challenges fell into 5 categories: missing data, erroneous data, uninterpretable data, inconsistencies among providers and over time, and data stored in noncoded text notes. Suggested strategies to address these issues include data validation steps, use of surrogate markers, natural language processing, and statistical techniques. DISCUSSION: A number of EHR issues can hamper the extraction of valid data for cross-health system comparative effectiveness studies. Our case example cautions against a blind reliance on EHR data as a single definitive data source. Nevertheless, EHR data are superior to administrative or claims data alone, and are cheaper and timelier than clinical trials or manual chart reviews. All 4 participating health systems are pursuing pathways to more effectively use EHR data for CER.A partnership between clinicians, researchers, and information technology specialists is encouraged as a way to capitalize on the wealth of information contained in the EHR. Future developments in both technology and care delivery hold promise for improvement in the ability to use EHR data for CER.

Comparative effectiveness research using electronic health records: impacts of oral antidiabetic drugs on the development of chronic kidney disease.

PURPOSE: Little is known about the comparative effects of common oral antidiabetic drugs ([OADs] metformin, sulfonylureas, or thiazolidinediones [THZs]) on chronic kidney disease (CKD) outcomes in patients newly diagnosed with type 2 diabetes (T2DM) and followed in community primary care practices. Electronic health records (EHRs) were used to evaluate the relationships between OAD class use and incident proteinuria and prevention of glomerular filtration rate decline. METHODS: A retrospective cohort study on newly diagnosed T2D cases requiring OADs documented in the EHRs of two primary care networks between 1998 and 2009 was conducted. CKD outcomes were new-onset proteinuria and estimated GFR (eGFR) falling below 60 ml/min/1.73 m(2). OAD exposures defined cohorts. Hazard ratios represent differential CKD outcome risk per year of OAD class use. RESULTS: A total of 798 and 977 patients qualified for proteinuria and eGFR outcome analyses, respectively. With metformin as the reference group, sulfonylurea exposure trended toward association with an increased risk of developing proteinuria ([adjusted hazard ratio; 95% CI] 1.27; 0.93, 1.74); proteinuria risk associated with THZ exposure (1.00; 0.70, 1.42) was similar to metformin. Compared with metformin, sulfonylurea exposure was associated with an increased risk of eGFR reduction to <60 ml/min/1.73 m(2) (1.41; 1.05, 1.91). THZ exposure (1.04; 0.71, 1.50) was not associated with change in the risk of eGFR decline. CONCLUSIONS: In a primary care population, metformin appeared to decrease the risk of CKD development compared with sulfonlyureas; risks of CKD development between metformin and THZs were similar. EHR use in pharmacotherapy comparative effectiveness research creates specific challenges and study limitations.

The incident user design in comparative effectiveness research.

Comparative effectiveness research includes cohort studies and registries of interventions. When investigators design such studies, how important is it to follow patients from the day they initiated treatment with the study interventions? Our article considers this question and related issues to start a dialogue on the value of the incident user design in comparative effectiveness research. By incident user design, we mean a study that sets the cohort's inception date according to patients' new use of an intervention. In contrast, most epidemiologic studies enroll patients who were currently or recently using an intervention when follow-up began. We take the incident user design as a reasonable default strategy because it reduces biases that can impact non-randomized studies, especially when investigators use healthcare databases. We review case studies where investigators have explored the consequences of designing a cohort study by restricting to incident users, but most of the discussion has been informed by expert opinion, not by systematic evidence.

Effective strategies to improve the management of diabetes: case illustration from the diabetes health and wellness institute.

Many patients with diabetes do not have access to clinical care or medications, resulting in cases of undiagnosed diabetes or uncontrolled diabetes, especially in patients of low socioeconomic status. Given these considerations, new strategies are needed to control the rampant growth of diabetes and prevent new cases. This article discusses effective strategies for improving the management of diabetes in underserved populations, with special reference to the Juanita J. Craft Diabetes Health and Wellness Institute, a unique partnership between a large, urban integrated health care system, the City of Dallas, and a South Dallas community.

The effectiveness of implementing an electronic health record on diabetes care and outcomes.

OBJECTIVE: To assess the impact of electronic health record (EHR) implementation on primary care diabetes care. DATA SOURCES: Charts were abstracted semi-annually for 14,051 diabetes patients seen in 34 primary care practices in a large, fee-for-service network from January 1, 2005 to December 31, 2010. The study sample was limited to patients aged 40 years or older. STUDY DESIGN: A naturalistic experiment in which GE Centricity Physician Office-EMR 2005 was rolled out over a staggered 3-year schedule. DATA COLLECTION: Chart audits were conducted using the AMA/Physician Consortium Adult Diabetes Measure set. The primary outcome was the HealthPartners' "optimal care" measure: HbA1c ≤ 8 percent; LDL cholesterol < 100 mg/dl; blood pressure < 130/80 mmHg; not smoking; and documented aspirin use in patients ≥ 40 years of age. PRINCIPAL FINDINGS: After adjusting for patient age, sex, and insulin use, patients exposed to the EHR were significantly more likely to receive "optimal care" when compared with unexposed patients (p < .001), with an estimated difference of 9.20 percent (95% CI: 6.08, 12.33) in the final year between exposed patients and patients never exposed. Components of the optimal care bundle showing positive improvement after adjustment were systolic blood pressure <80 mmHg, diastolic blood pressure <130 mmHg, aspirin prescription, and smoking cessation. Among patients exposed to EHR, all process and outcome measures except HbA1c and lipid control showed significant improvement. CONCLUSION: Implementation of a commercially available EHR in primary care practice may improve diabetes care and clinical outcomes.

Initial and subsequent therapy for newly diagnosed type 2 diabetes patients treated in primary care using data from a vendor-based electronic health record.

BACKGROUND: Diabetes is a leading cause of death and disability, and its prevalence is increasing. When diet fails, patients with type 2 diabetes mellitus (T2DM) are prescribed oral hypoglycemics for glycemic control. Few studies have explored initial use or change from initial oral hypoglycemic therapy in the primary care setting. We aimed to describe the utilization of initial oral hypoglycemics among newly diagnosed patients with diabetes from 1998-2009 and changes from initial to subsequent therapy among patients prescribed older oral hypoglycemic agents using electronic health records. METHODS: This observational cohort study used electronic health records from newly diagnosed patients with T2DM between 1 January 1998 and 31 March 2009 at two large health systems in the USA. Oral hypoglycemics included older (biguanide, sulfonylurea, and thiazolidinedione) and newer agents (incretin mimetic agents, alpha-glucosidase inhibitors, and D-phenylalanine derivatives). Multinomial regression models were fit to evaluate initial older oral hypoglycemic medication. We used incidence density sampling and conditional logistic regression models to evaluate predictors of regimen change. RESULTS: Most patients were treated from the biguanide class of oral hypoglycemics (67%), but there were differences in initial prescribing by age and race. HbA1c (Odds Ratio for HbA1c 7.0-8.9 vs < 7.0, 5.87 [95% Confidence Interval: 3.62-9.52]; Odds Ratio for HbA1c ≥ 9 vs < 7.0, 20.25 [95% Confidence Interval: 8.32-49.29] and Black people (Odds Ratio, 0.29 [95% Confidence Interval: 0.14, 0.60]) versus White people were associated with regimen change in the adjusted analysis. CONCLUSIONS: Clinical and demographic characteristics influence choice and duration of initial oral hypoglycemic treatment as well as regimen changes.

The financial and nonfinancial costs of implementing electronic health records in primary care practices.

The incentives in the American Recovery and Reinvestment Act to expand the "meaningful use" of electronic health record systems have many health care professionals searching for information about the cost and staff resources that such systems require. We report the cost of implementing an electronic health record system in twenty-six primary care practices in a physician network in north Texas, taking into account hardware and software costs, as well as the time and effort invested in implementation. For an average five-physician practice, implementation cost an estimated $162,000, with $85,500 in maintenance expenses during the first year. We also estimate that the HealthTexas network implementation team and the practice implementation team needed 611 hours, on average, to prepare for and implement the electronic health record system, and that "end users"-physicians, other clinical staff, and nonclinical staff-needed 134 hours per physician, on average, to prepare for use of the record system in clinical encounters.

Impact of a standardized heart failure order set on mortality, readmission, and quality and costs of care.

OBJECTIVE: To determine the impact of a standardized heart failure order set on mortality, readmission, and quality and costs of care. DESIGN: Observational study. SETTING: Eight acute care hospitals and two specialty heart hospitals. PARTICIPANTS: All adults (>18 years) discharged from one of the included hospitals between December 2007 and March 2009 with a diagnosis of heart failure, who had not undergone heart transplant, did not have a left ventricular assistive device, and with a length of stay of 120 or less days. INTERVENTIONS: A standardized heart failure order set was developed internally, with content driven by the prevailing American College of Cardiology/American Heart Association clinical practice guidelines, and deployed systemwide via an intranet physician portal. MAIN OUTCOME MEASURES: Publicly reported process of care measures, in-patient mortality, 30-day mortality, 30-day readmission, length of stay, and direct cost of care were compared for heart failure patients treated with and without the order set. RESULTS: Order set used reached 73.1% in March 2009. After propensity score adjustment, order set use was associated with significantly increased core measures compliance [odds ratio (95% confidence interval) = 1.51(1.08; 2.12)] and reduced in-patient mortality [odds ratio (95% confidence interval) = 0.49(0.28; 0.88)]. Reductions in 30-day mortality and readmission approached significance. Direct cost for initial admissions alone and in combination with readmissions were significantly lower with order set use. CONCLUSIONS: Implementing an evidence-based standardized order set may help improve outcomes, reduce costs of care and increase adherence to evidence-based processes of care.

Implementing a standardized order set for community-acquired pneumonia: impact on mortality and cost.

BACKGROUND: Order sets have shown some success in improving compliance with clinical guidelines, as well as patient and financial outcomes. Baylor Health Care System (BHCS) deployed a standardized adult pneumonia order set throughout its eight acute care hospitals in 2006. METHODS: All non-comfort care adult patients admitted with community-acquired pneumonia who met The Joint Commission definition of pneumonia and were discharged from an acute care BHCS hospital for a 30-month period (March 1, 2006-August 31, 2008) were included. Mortality, core measures compliance, and direct cost were compared for patients who did and did not receive the order set. RESULTS: Some 4,454 patients met study inclusion criteria. Significant variation in use between hospitals, however, persisted. Unadjusted analysis showed significant reductions in inhospital mortality, 30-day mortality, and direct cost and a significant increase in core measures compliance. Following risk adjustment, the difference in core measures compliance was retained (relative risk [95% confidence interval (C.I.)] 1.08 [1.03, 1.12]). Inhospital mortality and 30-day mortality reductions both approached significance (hazard ratios [95% C.I.] of 0.73 [0.51,1.02] and 0.79 [0.62, 1.00], respectively). Mean (standard error) benefits of order set use in in-hospital mortality and costs were estimated at 1.67 (0.62)% and $383 (207). The incremental cost-effectiveness ratio point estimate was -$22,882 per life saved, with an upper 95% confidence limit of$1,278 per life saved. DISCUSSION: Widespread adoption of the order set was achieved, with use consistently at or above 75% across all BHCS acute care hospitals since February 2007. The reductions in mortality observed with order set use, in combination with the favorable estimate of cost-effectiveness, make standardized evidence-based order sets an attractive improvement methodology for improving quality of pneumonia care.

Financial performance of primary care physician practices prior to electronic health record implementation.

While electronic health records (EHRs) are being widely implemented across the nation, few empirical data are currently available regarding their potential impact on financial performance and resource use. HealthTexas Provider Network is implementing a networkwide EHR, providing a unique opportunity to describe and evaluate fiscal effects. We conducted a retrospective, longitudinal observational study of financial performance related to inputs and income- and productivity-related outputs for the 33 primary care practices (July 2002-April 2006). Models for each outcome were constructed to test for a linear trend over time, adjusted for practice characteristics. F tests based on these models were used to determine the effect of each adjustor and to determine existence of a trend in each outcome. The observed staff per physician full-time equivalent (FTE) (3.6) was similar to staffing ratios reported for other primary care-only practices, while observation of 4692 work relative value units per physician FTE annually was higher than reported nationally. Significant monthly trends were identified for three of the outcome measures. During the pre-EHR baseline period, staffing ratios were equivalent to and physician productivity greater than reports available for these measures nationally or in other settings. Identification of time trends in three measures will allow these to be accounted for in the model used to evaluate the financial performance impact of EHR implementation.