Cost-effectiveness and impact on infections and associated antimicrobial resistance of 20-valent pneumococcal conjugate vaccine in US children previously immunized with PCV13.

AIM: The US Food and Drug Administration approved the 20-valent pneumococcal conjugate vaccine (PCV20) to prevent pneumococcal disease. In the context of routine PCV20 vaccination, we evaluated the cost-effectiveness and public health and economic impact of a PCV20 catch-up program and estimated the number of antibiotic prescriptions and antibiotic-resistant infections averted. MATERIALS AND METHODS: A population-based, multi-cohort, decision-analytic Markov model was developed using parameters consistent with previous PCV20 cost-effectiveness analyses. In the intervention arm, children aged 14-59 months who previously completed PCV13 vaccination received a supplemental dose of PCV20. In the comparator arm, no catch-up PCV20 dose was given. The direct and indirect benefits of vaccination were captured over a 10-year time horizon. RESULTS: A PCV20 catch-up program would prevent 5,469 invasive pneumococcal disease cases, 50,286 hospitalized pneumonia cases, 218,240 outpatient pneumonia cases, 582,302 otitis media cases, and 1,800 deaths, representing a net gain of 30,014 life years and 55,583 quality-adjusted life years. Furthermore, 720,938 antibiotic prescriptions and 256,889 antibiotic-resistant infections would be averted. A catch-up program would result in cost savings of $800 million. These results were robust to sensitivity and scenario analyses. CONCLUSIONS: A PCV20 catch-up program could prevent pneumococcal infections, antibiotic prescriptions, and antimicrobial-resistant infections and would be cost-saving in the US.

Cost-Effectiveness of 20-Valent Pneumococcal Conjugate Vaccine Among US Children with Underlying Medical Conditions.

INTRODUCTION: A 20-valent pneumococcal conjugate vaccine (PCV20) was recently recommended for use among US children. We evaluated the cost-effectiveness of PCV20 among children aged 6 years with chronic medical conditions (CMC+) and children aged 6 years with immunocompromising conditions (IC) versus one and two doses of 23-valent pneumococcal polysaccharide vaccine (PPSV23), respectively. METHODS: A probabilistic model was employed to depict 10-year risk of clinical outcomes and economic costs of pneumococcal disease, reduction in life years from premature death, and expected impact of vaccination among one cohort of children with CMC+ and IC aged 6 years. Vaccine uptake was assumed to be 20% for both PCV20 and PPSV23. Cost per quality-adjusted life year (QALY) gained was evaluated from the US societal and healthcare system perspectives; deterministic and probabilistic sensitivity analyses (DSA/PSA) were also conducted. RESULTS: Among the 226,817 children with CMC+ aged 6 years in the US, use of PCV20 (in lieu of PPSV23) was projected to reduce the number cases of pneumococcal disease by 5203 cases, medical costs by US$8.7 million, and nonmedical costs by US$6.2 million. PCV20 was the dominant strategy versus PPSV23 from both the healthcare and societal perspectives. In the PSA, 99.9% of the 1000 simulations yielded a finding of dominance for PCV20. Findings in analyses of children with IC aged 6 years in the USA were comparable (i.e., PCV20 was the dominant vaccination strategy). Scenario analyses showed that increasing PCV20 uptake to 100% could potentially prevent > 22,000 additional cases of pneumococcal disease and further reduce medical and nonmedical costs by US$70.0 million among children with CMC+ and IC. CONCLUSIONS: Use of PCV20 among young children with CMC+ and IC in the USA would reduce the clinical burden of pneumococcal disease and yield overall cost savings from both the US healthcare system and societal perspectives. Higher PCV20 uptake could further reduce the number of pneumococcal disease cases in this population.

Cost-effectiveness of 20-valent pneumococcal conjugate vaccine in US infants.

BACKGROUND: As of June 2023, two pneumococcal conjugate vaccines, 20- (PCV20) and 15- (PCV15) valent formulations, are recommended for US infants under a 3 + 1 schedule. This study evaluated the health and economic impact of vaccinating US infants with a new expanded valency PCV20 formulation. METHODS: A population-based, multi cohort, decision-analytic Markov model was developed to estimate the public health impact and cost-effectiveness of PCV20 from both societal and healthcare system perspectives over 10 years. Epidemiological data were based on published studies and unpublished Active Bacterial Core Surveillance System (ABCs) data. Vaccine effectiveness was based on PCV13 effectiveness and PCV7 efficacy studies. Indirect impact was based on observational studies. Costs and disutilities were based on published data. PCV20 was compared to both PCV13 and PCV15 in separate scenarios. RESULTS: Replacing PCV13 with PCV20 in infants has the potential to avert over 55,000 invasive pneumococcal disease (IPD) cases, 2.5 million pneumonia cases, 5.4 million otitis media (OM) cases, and 19,000 deaths across all ages over a 10-year time horizon, corresponding to net gains of 515,000 life years and 271,000 QALYs. Acquisition costs of PCV20 were offset by monetary savings from averted cases resulting in net savings of $20.6 billion. The same trend was observed when comparing PCV20 versus PCV15, with a net gain of 146,000 QALYs and $9.9 billion in net savings. A large proportion of the avoided costs and cases were attributable to indirect effects in unvaccinated adults and elderly. From a health-care perspective, PCV20 was also the dominant strategy compared to both PCV13 and PCV15. CONCLUSIONS: Infant vaccination with PCV20 is estimated to further reduce pneumococcal disease and associated healthcare system and societal costs compared to both PCV13 and PCV15.

Burden of pneumococcal disease due to serotypes covered by the 13-valent and new higher-valent pneumococcal conjugate vaccines in the United States.

The addition of pneumococcal conjugate vaccines (PCVs) to the United States (US) national immunization program led to significant reductions in incidence, mortality, and associated sequelae caused by pneumococcal disease (PD) in children and adults through direct and indirect protection. However, there remains clinical and economic burden due to PD caused by serotypes not included in the current 13-valent PCV (PCV13) formulation. To address this unmet need, 15-valent PCV (PCV15) and 20-valent PCV (PCV20), containing additional serotypes to PCV13, were recently approved in the US for adults and are anticipated for pediatrics in the near future. The study objective was to estimate the annual number of cases, deaths, and economic burden of PD due to serotypes included in PCV13, PCV15, and PCV20 for both US pediatric and adult populations. An Excel-based model was developed to calculate clinical and economic outcomes using published age-group specific serotype coverage; incidence of invasive PD, community-acquired pneumonia, and acute otitis media; case fatality rates; and disease-related costs. The results showed that across all age groups, the estimated annual PD cases and associated deaths covered by PCV13 serotypes were 914,199 and 4320, respectively. Compared with PCV13 serotypes, the additional 2 and 7 serotypes covered by PCV15 and PCV20 were attributed with 550,475 and 991,220 annual PD cases, as well as 1425 and 3226 annual deaths, respectively. This clinical burden translates into considerable economic costs ranging from $903 to $1,928 million USD that could be potentially addressed by PCV15 and PCV20. The additional serotypes included in PCV20 contribute substantially to the clinical and economic PD burden in the US pediatric and adult populations. Despite the success of the PCV13 pediatric national immunization program and increased adult uptake of PCV13 and 23-valent polysaccharide vaccine, broader PCV serotype coverage is needed across all ages to further reduce pneumococcal disease burden.

Twenty-Year Public Health Impact of 7- and 13-Valent Pneumococcal Conjugate Vaccines in US Children.

Pneumococcal conjugate vaccines (PCVs) have been used in the United States since 2000. To assess the cumulative 20-year effect of PCVs on invasive pneumococcal disease (IPD) incidence among children <5 years of age, we analyzed Active Bacterial Core Surveillance data, conducted a literature review, and modeled expected and observed disease. We found that PCVs have averted >282,000 cases of IPD, including ≈16,000 meningitis, ≈172,000 bacteremia, and ≈55,000 bacteremic pneumonia cases. In addition, vaccination has prevented 97 million healthcare visits for otitis media, 438,914-706,345 hospitalizations for pneumonia, and 2,780 total deaths. IPD cases declined 91%, from 15,707 in 1997 to 1,382 in 2019. Average annual visits for otitis media declined 41%, from 78 visits/100 children before PCV introduction to 46 visits/100 children after PCV13 introduction. Annual pneumonia hospitalizations declined 66%-79%, from 110,000-175,000 in 1997 to 37,000 in 2019. These findings confirm the substantial benefits of PCVs for preventing IPD in children.

The rationale for use of clinically defined outcomes in assessing the impact of pneumococcal conjugate vaccines against pneumonia.

Introduction: When evaluating the public health value of adult pneumococcal conjugate vaccine (PCV) for pneumonia, regulatory agencies and vaccine technical committees (VTCs) emphasize vaccine serotype (VT), radiologically confirmed community-acquired pneumonia (CAP) to the exclusion of clinically defined pneumonia and thus may underestimate PCV's public health value.Areas covered: We review the critiques that have been raised to using clinically defined pneumonia as a complement to VT-CAP in evaluating the public health value of adult PCVs.Expert opinion: PCV13 efficacies for preventing hospitalized CAP ranged from 6% to 11% and for a combination of primary and secondary care from 4% to 12%, with relatively high associated rate reductions. These efficacy values are larger than estimated from multiplying PCV13 efficacy against vaccine-type CAP by the proportion of CAP identified as vaccine-type through tests, such as a serotype-specific urinary antigen detection assay. Current understanding of pneumococcal epidemiology and limitations of diagnostic tests suggest the efficacy values for clinically defined outcomes are plausible and potentially generalizable. Regulatory agencies and VTCs have accepted clinically defined outcomes for assessing pediatric vaccines and - while additional studies assessing adult clinical CAP VE are needed - they might consider existing data when evaluating adult PCV use.

A review of the immunogenicity, safety and current recommendations for the meningococcal serogroup B vaccine, MenB-FHbp.

WHAT IS KNOWN AND OBJECTIVE: This review describes invasive meningococcal disease (IMD) epidemiology in the United States, provides a brief overview of available meningococcal vaccines and discusses meningococcal serogroup B (MenB) vaccine development. Particular focus is given to the recombinant protein MenB vaccine, MenB-FHbp (Trumenba® , bivalent rLP2086) in light of recent publication of phase 3 data; the other MenB vaccine (Bexsero® , MenB-4C) has been recently reviewed. Current recommendations of the US Advisory Committee on Immunization Practices (ACIP) for MenB vaccination and potential barriers to immunization are also discussed. METHODS: Using the published literature, this article reviews the development and use of MenB-FHbp to date, with a focus on the United States. RESULTS AND DISCUSSION: Despite the availability of medical treatment, IMD is associated with significant mortality and frequently occurring serious permanent sequelae in surviving individuals. Worldwide, most IMD is caused by six serogroups (A, B, C, W, X and Y). MenB is the most common disease-causing meningococcal serogroup in the United States and has caused several recent university-based IMD outbreaks. MenB vaccines, including MenB-FHbp, are available in the United States. ACIP recommends that all individuals ≥10 years of age at increased risk for meningococcal disease receive MenB vaccination; healthy individuals 16-23 years of age are recommended MenB vaccines based on individual clinical decision-making. MenB-FHbp is used on a 2-dose schedule (0, 6 months) when vaccinating healthy individuals and on a tailored 3-dose schedule (0, 1-2, 6 months) in cases of increased risk. WHAT IS NEW AND CONCLUSION: Because vaccination provides the most effective protection against IMD, pharmacists are in an excellent position to offer evidence-based vaccine information, as well as to encourage and provide meningococcal immunizations to adolescents and young adults.

Preferences for Adult Pneumococcal Vaccine Recommendations Among United States Health Care Providers.

INTRODUCTION: In 2014, the Advisory Committee on Immunization Practices (ACIP) of the US Centers for Disease Control and Prevention (CDC) recommended 13-valent pneumococcal conjugate vaccine (PCV13) followed by 23-valent pneumococcal polysaccharide vaccine (PPSV23) for all adults aged ≥ 65 years, with a commitment to revisit the recommendation for PCV13 because of declining vaccine-type disease. The Evidence-to-Recommendation framework used by the ACIP includes review of evidence regarding feasibility and stakeholder acceptability, but no surveys of vaccinator preferences have been published in the literature. METHODS: Physicians (N = 700), physician assistants (N = 100), pharmacists (N = 100), and nurse practitioners (N = 100) who recently prescribed, administered, or recommended adult pneumococcal vaccine were surveyed in March 2018. Object-case best-worst scaling was used to assess preferences among potential recommendation scenarios: retaining the then-current 2014 recommendation without a scheduled re-evaluation, retaining with a scheduled re-evaluation, revising PCV13 to Category B (retaining PPSV23 as Category A), removing PCV13 (retaining PPSV23 as Category A), and removing both PCV13 and PPSV23. RESULTS: Providers' most preferred recommendations were retaining the 2014 recommendation with another planned re-evaluation (52.6%) and retaining the then-current recommendation without planned re-evaluation (40.0%). Few preferred changing PCV13 to Category B (3.2%), removing PCV13 (3.7%), or removing both pneumococcal vaccines (0.5%). CONCLUSIONS: The majority of vaccinators surveyed preferred to retain the 2014 recommendation, either with another scheduled reassessment or indefinitely. FUNDING: Pfizer, Inc.

Disparities in uptake of 13-valent pneumococcal conjugate vaccine among older adults in the United States.

BACKGROUND: In September 2014, 13-valent pneumococcal conjugate vaccine (PCV13) was universally recommended for all US adults aged ≥65 years. Adult PCV13 coverage, including whether disparities in uptake exist, however, is not well-described. METHODS: We used a monthly series of cross-sectional analyses of administrative medical and prescription claims data collected by IQVIA and linked to sociodemographic data collected by Experian to estimate overall and subpopulation-level uptake of PCV13 among US adults aged ≥65 years. RESULTS: Among adults aged ≥65 years, 43.3% received PCV13 by the end of November 2017. Race/ethnicity, annual household income, education status, and neighborhood urbanicity were strongly related to PCV13 uptake among adults aged ≥65 years. Lower uptake of PCV13 was observed for non-Hispanic black (36.3%) and Hispanic (30.0%) adults (vs 45.6% for non-Hispanic whites, P < .01), the poor (30.7% vs 54.2% among lowest vs highest income deciles, P < .01), adults with low educational status (33.0% vs 49.0% among those without high school education vs college educated, P < .01), and those living in rural communities (22.9%) or urban/inner-city (33.8%) areas (vs 45.8% in suburban areas, P < .01). CONCLUSIONS: PCV13 uptake among adults aged ≥65 occurred rapidly in the three years after universal recommendation in September 2014. Yet, poor and minority communities, rural and urban/inner-city areas, and communities with low educational attainment had substantially lower PCV13 coverage. These same populations are at increased risk of pneumococcal disease. In order to maximize the benefits of pneumococcal vaccination, further targeted and tailored interventions to increase PCV13 uptake in these underserved populations are still necessary.

Pneumococcal conjugate vaccine use for the prevention of pneumococcal disease in adults <50 years of age.

INTRODUCTION: Adults, particularly those with underlying chronic conditions, eg, cardiovascular, liver, and pulmonary diseases and diabetes mellitus, have a persistent pneumococcal disease burden. Thirteen-valent pneumococcal conjugate vaccine (PCV13) is recommended in the United States for all adults aged ≥65 years and immunocompromised adults aged <65 years to protect against vaccine-serotype (VT) invasive pneumococcal disease (IPD) and pneumonia. PCV13 is not recommended for immunocompetent adults aged ≥18 years with comorbidities associated with increased pneumococcal disease risk. AREAS COVERED: This US-focused review summarizes PCV13-type IPD and community-acquired pneumonia burden in adults aged <50 years, PCV13 immunogenicity and safety in this population, and adult pneumococcal vaccination recommendations. EXPERT COMMENTARY: Considering (i) PCV13 has demonstrated efficacy against VT-IPD and pneumonia in adults aged ≥65 years (with or without underlying chronic conditions), and (ii) immune responses to PCV13 in younger adults are comparable or better than in older adults, PCV13 would likely have similar efficacy in adults aged <50 years. Recommending PCV13 for at-risk adults aged <50 years would provide direct immunologic benefit of a conjugate vaccine and could address an important unmet medical need for pneumococcal pneumonia prevention. Although not directly addressed here, this benefit would likely extend to at-risk adults aged 50-64 years.

Risk of underlying chronic medical conditions for invasive pneumococcal disease in adults.

PURPOSE: In the United States, the 13-valent pneumococcal conjugate vaccine is recommended in persons ⩾65years of age, and persons ⩽65years of age with immunocompromising (IC) conditions. For invasive pneumococcal disease (IPD) prevention in those ⩽65 with non-IC medical conditions, the 23-valent polysaccharide vaccine is recommended. This group is at higher risk of IPD than the general population, but the level of risk is not well-quantified. We estimated IPD risk by individual underlying medical conditions, and by total number of conditions, for persons ⩾18years of age. We calculated the relative risks (RR) of various medical conditions, comparing the incident IPD cases to the general study population, and used Poisson regression models to estimate an IPD RR, adjusting for other conditions. We also examined IPD incidence by number of conditions diagnosed in each calendar year, using a risk-stacking model. RESULTS: Underlying medical conditions with the highest adjusted RR for IPD were chronic liver disease (RR 2.1, 95% CI 1.5-2.8) and chronic obstructive pulmonary disease (COPD; RR 2.1, 95% CI 1.8-2.5). IPD risk increased with increasing number of medical conditions: adjusted RR, 2.2 (95% CI 1.9-2.5) 1 condition, 2.9 (2.5-3.5) for 2 conditions, and 5.2 (4.4-6.1) for 3 conditions. CONCLUSIONS: For persons with a single, non-IC medical condition, IPD risk was twice that for the general KPNC population. Persons with multiple, non-IC chronic conditions exhibited increased IPD risk with each additional condition. Such information may inform discussions on recommendations for adult pneumococcal immunization and prevention.

Safety of Perflutren Ultrasound Contrast Agents: A Disproportionality Analysis of the US FAERS Database.

INTRODUCTION: Perflutren microbubble/microsphere ultrasound contrast agents have a black-box warning based on case reports of serious cardiopulmonary events. There have been several subsequent observational safety studies. Large spontaneous reporting databases may help detect/refine signals of rare adverse events that elude other data sources/study designs. OBJECTIVE: The objective of this study was to supplement existing knowledge of the reported safety of perflutren using statistical analysis of spontaneous reports. METHODS: We analyzed information from the US Food and Drug Administration Adverse Event Reporting System using a disproportionality analysis. Analysis of overall reporting for perflutren was supplemented by subset (age, indication) analysis. A signal of disproportionate reporting (SDR) was defined as EB05 >2. RESULTS: Overall, 18/380 Preferred Terms and 1/83 Standardized Medical Queries had SDRs. Most were small (EB05 = 2-4). Back pain and flank pain were the largest SDRs followed by events compatible with signs/symptoms of hypersensitivity. The general pattern of SDRs in the subset analysis was consistent with the overall analysis. Almost all events with SDRs were literally or conceptually labeled. Except for chest pain (higher in the age <65 years subgroup) and back pain (higher in the age ≥65 years subgroup), there were no statistically significant differences between age subsets. Except for the Preferred Terms Pruritus and Urticaria and the narrow Standardized Medical Queries Ventricular tachyarrhythmia, Angioedema, Oropharyngeal allergic conditions, and Hypersensitivity (higher in the stress test subgroup), there were no statistically significant reporting differences between indication subsets. There were no SDRs associated with the major cardiovascular events of death, myocardial infarction/ischemia, angina, arrhythmias, or convulsions in any analysis. CONCLUSIONS: Our combined signal detection/evaluation analysis did not identify SDRs of novel adverse events or major cardiovascular events associated with perflutren ultrasound contrast agents. The negative results for major cardiovascular events extend previous signal evaluation exercises supporting the relative cardiovascular safety of these agents.

Improving adult immunization practices using a team approach in the primary care setting.

OBJECTIVES: The objective of this study was to improve the immunization rates of primary care practices using a team approach. METHODS: Practices performed 35 random chart abstractions at 2 time points and completed a survey about immunizations at baseline and 12 months after intervention. Data were collected for the following immunizations: influenza, pneumococcal, tetanus diphtheria (Td)/tetanus diphtheria pertussis (Tdap), hepatitis A, hepatitis B, meningococcal, varicella, herpes zoster, and human papilloma virus. Between baseline and after intervention, practice teams were given feedback reports and access to an online educational tool, and attended quality improvement coaching conference calls. RESULTS: Statistically significant improvements were seen for Td/Tdap (45.6% pre-intervention, 55.0% post-intervention; P ≤ .01), herpes zoster (12.3% pre-intervention, 19.3% post-intervention; P ≤ .01), and pneumococcal (52.2% pre-intervention, 74.5% post-intervention; P ≤ .01) immunizations. Data also revealed an increase in the number of physicians who discussed herpes zoster and pneumococcal vaccinations with their patients (23.2% pre-intervention, 43.3% post-intervention; P ≤ .01 and 19.9% pre-intervention, 43.0% post-intervention; P ≤ .01, respectively) as well as an increase in physicians using the Centers for Disease Control and Prevention immunization schedule (52.9% pre-intervention, 88.2% post-intervention; P ≤ .02). CONCLUSIONS: The immunization rates of the primary care practices involved in this study improved.

Raising achievement: educating physicians to address effects of at-risk drinking on common diseases.

BACKGROUND: Despite a high prevalence, internists rarely screen for at-risk drinking. A contributing factor is likely to be physicians' limited understanding of the negative effects that at-risk drinking can have on common clinical conditions managed on a daily basis. OBJECTIVE: To develop and conduct a pre-post pilot evaluation of a web-based educational programme to educate and support physicians to assess alcohol use in patients with sleep disorders, depression and hypertension. METHODS: An expert panel developed a programme that addressed: 1) screening for alcohol use; 2) evidence on effect of alcohol on hypertension, sleep disorders and depression; 3) brief interventions for at-risk drinking with patient education materials; and 4) codes for payment of brief alcohol interventions. From an internist network, 17 physicians were recruited for a pilot test of the web-based educational programme. All participants were surveyed at baseline and at an end point three months after the intervention about attitudes, knowledge and beliefs about at-risk drinkers and effects of alcohol on hypertension, sleep disorders and depression. RESULTS: Among the 17 study physicians: 1) most believed that at-risk drinking affected their ability to treat hypertension, sleep disorders and depression (77% at baseline and 65% at end point); 2) nearly all were aware that at-risk drinking affects hypertension, sleep disorders and depression (94% at baseline and 94% at end point); and 3) 94% rated the educational programme positively at the end point. Frustration with managing at-risk alcohol use decreased (from 71% at baseline to 53% at end point) and study physicians' self-reported screening for at-risk drinking increased for new patients (from 47% at baseline to 71% at end point) and established patients (from 35% at baseline to 47% at end point). CONCLUSION: This pilot of a web-based educational programme for internists was well received by study physicians. The programme increased screening for at-risk drinking while reducing frustration in dealing with this condition. Future work needs to evaluate this highly accessible programme in diverse practices and assess patient-related outcomes.

Use of intensive insulin therapy for the management of glycemic control in hospitalized patients: a clinical practice guideline from the American College of Physicians.

DESCRIPTION: The American College of Physicians (ACP) developed this guideline to present the evidence for the link between the use of intensive insulin therapy to achieve different glycemic targets and health outcomes in hospitalized patients with or without diabetes mellitus. METHODS: Published literature on this topic was identified by using MEDLINE and the Cochrane Library. Additional articles were obtained from systematic reviews and the reference lists of pertinent studies, reviews, and editorials, as well as by consulting experts; unpublished studies on ClinicalTrials.gov were also identified. The literature search included studies published from 1950 through March 2009. Searches were limited to English-language publications. The primary outcomes of interest were short-term mortality and hypoglycemia. This guideline grades the evidence and recommendations by using the ACP clinical practice guidelines grading system. RECOMMENDATION 1: ACP recommends not using intensive insulin therapy to strictly control blood glucose in non-surgical intensive care unit (SICU)/medical intensive care unit (MICU) patients with or without diabetes mellitus (Grade: strong recommendation, moderate-quality evidence). RECOMMENDATION 2: ACP recommends not using intensive insulin therapy to normalize blood glucose in SICU/MICU patients with or without diabetes mellitus (Grade: strong recommendation, high-quality evidence). RECOMMENDATION 3: ACP recommends a target blood glucose level of 7.8 to 11.1 mmol/L (140 to 200 mg/dL) if insulin therapy is used in SICU/MICU patients (Grade: weak recommendation, moderate-quality evidence).

Using online learning collaboratives to facilitate practice improvement for COPD: an ACPNet pilot study.

The purpose of this pilot study was to (1) understand the attitudes, knowledge, and beliefs of internists who manage patients with chronic obstructive pulmonary disease (COPD) and (2) evaluate the impact of a multifaceted approach to quality improvement (QI) work involving the management of COPD patients. This pilot study used a pre-post intervention design. The intervention included an online educational toolkit, QI coaching calls led by faculty, and the use of individual physician feedback reports to act as motivators for change. Data were collected using a practice pattern survey and a chart abstraction tool to identify discrepancies between perceived and actual care. Results from the pilot study showed a statistically significant improvement in quality indicators postintervention, suggesting a causal relationship with the multifaceted intervention. Discrepancies were identified between perceived and actual care in the areas of spirometry, pulse oximetry (exertion and resting), influenza and pneumococcal vaccinations, peak flow assessment, and inhaler use instruction.

Pain management and the primary care encounter: opportunities for quality improvement.

PURPOSE: The purpose of this pilot study was to create a comprehensive pain management educational toolkit for the primary care physician that offers guidance on current standards of care and quality improvement techniques to help curb educational and quality gaps in managing patients with pain. SCOPE: Pain often goes undetected in the primary care encounter, and when acknowledged, is often undertreated. METHODS: This pilot study utilized a pre-/postintervention design. Data were collected using a unique survey developed for this project. The intervention consisted of an online educational toolkit designed to improve the quality of care primary care physicians offer their patients with pain. RESULTS: Results demonstrated statistically significant improvements from pre- to postintervention for various measures including the following: (1) reported comfort in managing patients with cancer and fibromyalgia; (2) number of physicians who set functional goals for patients with pain; (3) screening for depression, substance abuse, and alcoholism; (4) documentation of efficacy of nonpharmacologic modalities; and (5) knowledge scores. CONCLUSION: The improvements seen from pre- to postintervention suggest the online toolkit had a positive impact on physician knowledge, practice patterns, and behavior toward pain management.

Practice redesign to improve care for falls and urinary incontinence: primary care intervention for older patients.

BACKGROUND: In primary care, medical care for age-associated conditions, such as falls and urinary incontinence (UI), is inadequate. In collaboration with the American College of Physicians, we augmented the Assessing Care of Vulnerable Elders practice redesign intervention to improve falls and UI care. METHODS: We performed a controlled trial in 5 nonrandomly selected primary care intervention (26 physicians across sites) and control (18 physicians) practices from diverse communities. Patients 75 years and older who screened positive for falls or fear of falling and UI were included in the study. We conducted a multicomponent intervention between October 30, 2006, and December 31, 2007, that included efficient collection of data, medical record prompts, patient education materials, and physician decision support. Main outcome measures were quality of care for falls and UI comparing intervention and control sites. RESULTS: Of 6051 patients screened, 2847 (47.1%) screened positive for falls or UI (46.1% in the intervention group and 48.8% in the control group). Across the 5 practices, 1211 patient medical records were evaluated after stratified random selection. Intervention patients received 60.0% of recommended care for falls vs 37.6% provided by control health care professionals (P < .001). Similarly, intervention health care professionals provided more recommended care for UI (47.2% vs 27.8%, P < .001). Intervention health care professionals more often performed a falls history, orthostatic blood pressure measurement, gait and balance examination, and UI history and tried UI behavioral treatments first. Knowledge about falls and UI increased more among intervention than control group health care professionals. CONCLUSIONS: Practice redesign can improve the care that community-based primary care physicians provide for older patients with falls and UI. Outcomes of such care improvements require further evaluation.

The development of clinical practice guidelines and guidance statements of the American College of Physicians: summary of methods.

The American College of Physicians (ACP) established its evidence-based clinical practice guidelines program in 1981. The ACP's Guidelines Committee and the staff of the Clinical Programs and Quality of Care Department develop the clinical recommendations. The ACP develops 2 different types of clinical recommendations: clinical practice guidelines and clinical guidance statements. The ACP clinical practice guidelines and guidance statements follow a multistep development process that includes a systematic review of the evidence, deliberation of the evidence by the committee, summary recommendations, and evidence and recommendation grading. All ACP clinical practice guidelines and clinical guidance statements, if not updated, are considered automatically withdrawn or invalid 5 years after publication or once an update has been issued.

Closing the gap-cardiovascular risk and primary prevention: results from the American College of Physicians quality improvement program.

The objective was to study the impact of a practice-based quality improvement program on practice teams' care for patients who have increased risk of cardiovascular disease. A total of 54 team members from 18 internal medicine practices participated in an educational program that used a pre-post intervention study design and focused on measures related to cardiovascular risk factors. The program involved live instruction, faculty-led conference calls, practice data collection, and progress reports detailing practices' improvement strategies. Data on 817 patients were reported. Practices showed significant improvement in counseling for diet (70% to 78%), exercise (67% to 74%), and weight loss (64% to 72%). Use of aspirin (53% to 64%) and statins (83% to 89%) also showed significant improvement. Administration of flu vaccine increased significantly from 51% to 54%. Improvements in patient counseling and medication management, if sustained, should lead to fewer cardiovascular events. However, program duration did not allow the capture of outcomes measures improvement.