Cost-effectiveness of an Adjuvanted Recombinant Zoster Vaccine in older adults in the United States.

In the United States, herpes zoster (HZ) and related complications are estimated to result in approximately $1.3 billion in medical care costs and $1.7 billion in indirect costs annually. In this study, we compared the cost-effectiveness of a new Adjuvanted Recombinant Zoster Vaccine (RZV), containing recombinant varicella-zoster virus glycoprotein E and the AS01B Adjuvant System, versus No Vaccine, as well as versus the live attenuated HZ vaccine (Zoster Vaccine Live (ZVL)) in subjects aged 60+ years of age (YOA) and other age cohorts aged 50+ YOA. A multi-cohort Markov model was developed which follows 1 million individuals over their remaining lifetimes from the year of vaccination with annual cycle lengths. Second dose compliance for RZV was assumed to be 69%. Efficacy and waning parameters were derived from clinical trials for both vaccines. Epidemiological parameters, costs and utility model inputs were derived from US-specific population-based data. Costs and outcomes were discounted at 3% per year. Deterministic and probabilistic sensitivity analysis, along with scenario and threshold analysis were carried out to explore the overall uncertainty in the model. The model estimated that, compared to No Vaccine against HZ, RZV would prevent 103,603 HZ cases, 11,197 postherpetic neuralgia (PHN) cases, and 14,455 other complications, at an incremental cost of $11,863 per quality-adjusted life-year saved from a societal perspective. Compared to ZVL, the model estimated that, RZV would prevent 71,638 additional HZ cases, 6403 PHN cases, and over 10,582 other complications, resulting in net total societal cost savings of over $96 million. The results were robust to a wide range of sensitivity analyses. Vaccination against HZ with RZV is cost-effective compared to No Vaccine and cost-saving compared to ZVL, in the US population aged 60+ YOA. Clinicaltrial.gov. registered#: NA.

Development and validation of the chronic hepatitis C virus treatment satisfaction (HCVTSat) instrument.

BACKGROUND: While current medications used to treat patients with chronic hepatitis C virus (HCV) effectively produce sustained viral response (SVR), postponement of therapy is often times attributed to patient perceptions of unfavourable outcomes. However, an instrument to assess patient perceptions of therapy (i.e. treatment satisfaction) has not been developed. AIM: To describe the development and validation the chronic Hepatitis C Virus Treatment Satisfaction (HCVTSat) instrument. METHODS: Focus groups, expert review and cognitive debriefing were used to develop a draft 37-item instrument (scale: 1 = not important at all; 5 = extremely important). The preliminary instrument was administered to a pre-test sample of 145 patients through Mayo Clinic, Rochester, MN. A refined HCVTSat was administered to a main sample of 333 participants with a chronic HCV diagnosis through Harris Interactive. RESULTS: The HCVTSat was completed by 333 participants with an average age of 51 (s.d. = 12.1) years, 55% male, current or previous HCV treatment experience, and a diagnosis of HCV for approximately 12 (s.d. = 8.9) years. Twelve items for the 3 dimensions, Treatment Experience (TE), Side Effects (SE) and Social Aspects (SA), were internally consistent (Cronbach's α range: 0.70-0.90), responsive and valid. Confirmatory factor analysis (goodness-of-fit indexes: χ(2) = 20.9, df = 23, P = 0.59; CFI = 1.00, GFI = 0.99, TFI = 1.00, RMSEA = 0.001) revealed a better fit with 9 items. All path coefficients were significant (P < 0.05). SE and SA were strong predictors of TE, while TE was positively associated with the 1-item global measure of TS (path coefficient = 0.12). CONCLUSIONS: The 10-item HCVTSat demonstrated valid psychometric properties and assessed patient satisfaction with HCV therapies. However, additional studies are needed to validate the HCVTSat in conjunction with SVR and in patients in underrepresented populations.

Long-term trends in carpal tunnel syndrome.

OBJECTIVE: To assess temporal trends in carpal tunnel syndrome (CTS) incidence, surgical treatment, and work-related lost time. METHODS: Incident CTS and first-time carpal tunnel release among Olmsted County, Minnesota, residents were identified using the medical records linkage system of the Rochester Epidemiology Project; 80% of a sample were confirmed by medical record review. Work-related CTS was identified from the Minnesota Department of Labor and Industry. RESULTS: Altogether, 10,069 Olmsted County residents were initially diagnosed with CTS in 1981-2005. Overall incidence (adjusted to the 2000 US population) was 491 and 258 per 100,000 person-years for women vs men (p < 0.0001) and 376 per 100,000 for both sexes combined. Adjusted annual rates increased from 258 per 100,000 in 1981-1985 to 424 in 2000-2005 (p < 0.0001). The average annual incidence of carpal tunnel release surgery was 109 per 100,000, while that for work-related CTS was 11 per 100,000. An increase in young, working-age individuals seeking medical attention for symptoms of less severe CTS in the early to mid-1980s was followed in the 1990s by an increasing incidence in elderly people. CONCLUSIONS: The incidence of medically diagnosed carpal tunnel syndrome (CTS) accelerated in the 1980s. The cause of the increase is unclear, but it corresponds to an epidemic of CTS cases resulting in lost work days that began in the mid-1980s and lasted through the mid-1990s. The elderly present with more severe disease and are more likely to have carpal tunnel surgery, which may have significant health policy implications given the aging population.

von Willebrand disease (VWD): evidence-based diagnosis and management guidelines, the National Heart, Lung, and Blood Institute (NHLBI) Expert Panel report (USA).

von Willebrand disease (VWD) is a commonly encountered inherited bleeding disorder affecting both males and females, causing mucous membrane and skin bleeding symptoms, and bleeding with surgical or other haemostatic challenges. VWD may be disproportionately symptomatic in women of child-bearing age. It may also occur less frequently as an acquired disorder (acquired von Willebrand syndrome). VWD is caused by deficiency or dysfunction of von Willebrand factor (VWF), a plasma protein that mediates platelet haemostatic function and stabilizes blood coagulation factor VIII. The pathophysiology, classification, diagnosis and management of VWD are relatively complex, but understanding them is important for proper diagnosis and management of patients with VWD. These evidence-based guidelines for diagnosis and management of VWD from the National Heart, Lung, and Blood Institute (NHLBI) Expert Panel (USA) review relevant publications, summarize current understanding of VWD pathophysiology and classification, and present consensus diagnostic and management recommendations based on analysis of the literature and expert opinion. They also suggest an approach for clinical and laboratory evaluation of individuals with bleeding symptoms, history of bleeding or conditions associated with increased bleeding risk. This document summarizes needs for further research in VWF, VWD and bleeding disorders, including clinical research to obtain more objective information about bleeding symptoms, advancements in diagnostic and therapeutic tools, and enhancement in the education and training of clinicians and scientists in bleeding and thrombotic disorders. The NHLBI Web site (http://www.nhlbi.nih.gov/guidelines/vwd) has a more detailed document, a synopsis of these recommendations, and patient education information.

Pharmacologic and anti-IgE treatment of allergic rhinitis ARIA update (in collaboration with GA2LEN).

The pharmacologic treatment of allergic rhinitis proposed by ARIA is an evidence-based and step-wise approach based on the classification of the symptoms. The ARIA workshop, held in December 1999, published a report in 2001 and new information has subsequently been published. The initial ARIA document lacked some important information on several issues. This document updates the ARIA sections on the pharmacologic and anti-IgE treatments of allergic rhinitis. Literature published between January 2000 and December 2004 has been included. Only a few studies assessing nasal and non-nasal symptoms are presented as these will be discussed in a separate document.

Dyspepsia consulters and patterns of management: a population-based study.

BACKGROUND: Although dyspepsia is common, management patterns in the United States are unknown. AIM: To determine the pattern of dyspepsia evaluation and treatment over 20 years in a population-based cohort, and test the hypothesis that the management was influenced by dyspepsia subgroup and gender. METHODS: The validated Bowel Disease Questionnaire was mailed to a random sample of Olmsted County, Minnesota residents (1988-1990). Of the 835 survey respondents, 213 subjects were identified as having dyspepsia according to Rome I Criteria. The medical chart of each dyspeptic subject who had not denied research authorization (n = 206) was reviewed to identify all episodes of care for dyspepsia symptoms 10 years before and 10 years after the date the Bowel Disease Questionnaire was completed. Of these 206 subjects (mean age 47 years, 48% female), 34% had ulcer-like dyspepsia, 32% had dysmotility-like dyspepsia, and 37% had reflux-like dyspepsia. RESULTS: Nearly half (n = 98, 48%) had episodes of care for dyspepsia symptoms over 20 years. Of these 98 subjects, 49% had upper gastrointestinal endoscopy, 4% motility studies and 12% were tested for Helicobacter pylori. At the first visit of the episode of care closest to Bowel Disease Questionnaire completion, 72% were seen in primary care, 16% in emergency medicine and 2% in gastroenterology. In addition, 13% were referred to gastroenterology clinic within this episode. During the study period, 70% were given an 'acid' diagnosis, 7% a 'motility' diagnosis and 54% a 'functional' diagnosis; 78% received acid suppression agents (28% proton pump inhibitors), 18% psychotropic agents and 7% prokinetic agents. No significant association was found between gender and test usage, specialty referral or type of treatment, although women were three times less likely to receive proton pump inhibitors (odds ratio 3.3, 95% CI: 1.2-9.1). Symptom severity, frequency and pattern were risk factors for health care seeking in dyspepsia. CONCLUSIONS: Delivery of care for dyspepsia was similar among dyspepsia subgroups and in men and women.

Incidence of a clinical diagnosis of the irritable bowel syndrome in a United States population.

BACKGROUND: The incidence of irritable bowel syndrome is uncertain. We aimed to determine the incidence of clinically diagnosed irritable bowel syndrome in the community. METHODS: Using the Rochester Epidemiology Project, all diagnoses of irritable bowel syndrome made among adult residents of Olmsted County, Minnesota, over a 3-year period were identified. The complete medical records of a random sample of the potential subjects were reviewed for the 10 years prior to the irritable bowel syndrome diagnosis and any patient who had received a previous diagnosis of irritable bowel syndrome was excluded (prevalent cases). RESULTS: The diagnostic index listed 1245 possible irritable bowel syndrome patients; 416 patient charts were reviewed and, of these, 149 were physician diagnosed incident cases of irritable bowel syndrome. The age- and sex-adjusted incidence rate was 196 per 100,000 person-years and increased with age (P = 0.006). The age-adjusted annual incidence per 100,000 in women was higher than in men: 238 vs. 141 (ratio 3:2; P = 0.005). The overall symptom frequency at the time of diagnosis was abdominal pain (73%), diarrhoea (41%) and constipation (16%). CONCLUSIONS: The incidence of a clinical diagnosis of irritable bowel syndrome in adults was estimated to be two per 1000 per year, increased with age and was higher in women than men. As many people with irritable bowel syndrome do not seek care, the true incidence of irritable bowel syndrome is likely to be higher.

Do published guidelines for evaluation of irritable bowel syndrome reflect practice?

BACKGROUND: The only US guidelines listed in the National Guideline Warehouse for the diagnosis of Irritable Bowel Syndrome (IBS) are the expert opinion guidelines published by The American Gastroenterology Association. Although the listed target audience of these guidelines includes family physicians and general internists, the care recommended in the guidelines has not been compared to actual primary care practice. This study was designed to compare expert opinion guidelines with the actual primary care provided and to assess outcomes in the 3 years following the IBS diagnosis. METHODS: This is a retrospective medical record review study using a random sample of incident IBS cases from all Olmsted County, Minnesota providers diagnosed between January 1, 1993 and December 31, 1995. Data was collected on all care and testing provided to the subjects as well as 3-year outcomes related to the IBS diagnosis. RESULTS: Of the 149 IBS patients, 99 were women and the mean age was 47.6 years. No patient had all of the diagnostic tests recommended in the guidelines. 42% had the basic blood tests of CBC and a chemistry panel. Sedimentation rate (2%) and serum thyroxine level (3%) were uncommon. Colon imaging studies were done in 41% including 74% of those over the age of 50. In the 3 years following the diagnosis, only one person had a change in diagnosis and no diagnoses of gastro-intestinal malignancies were made in the cohort. CONCLUSIONS: Primary care practice based diagnostic evaluations for IBS differ significantly from the specialty expert opinion-based guidelines. Implementation of the specialty guidelines in primary care practice would increase utilization with apparent limited improvement in diagnostic outcomes.

Tocolytic therapy for preterm labour: assessing its potential for reducing preterm delivery.

Preterm labour (PTL) is a major contributor to preterm delivery (PTD) but delivery is often not preventable by current therapies. We conducted this study to determine the proportion of women with PTL who were and who were not candidates for tocolytic therapy. The cohort comprised residents of Olmsted County, Minnesota who delivered at >20 weeks' gestation in 1985--94 and who experienced PTL. Medical records were abstracted to identify episodes of PTL, its treatment and outcome. We developed an algorithm that accounted for gestation at delivery and pregnancy complications to determine the proportion of pregnancies complicated by PTL that were candidates for tocolytic therapy. Of 651 pregnancies complicated by PTL, a 50% probability sample, stratified by delivery year, were selected and abstracted. The cumulative incidence of PTL ranged from 3.6 to 6.4 per 100 deliveries of live or stillborn infants. Tocolysis was not contraindicated for 49.4% of all women with PTL and for a third of women with only one PTL episode. Delivery was delayed to >35 weeks in 53.8% of candidates for tocolysis. Only an additional 11.7% of women with one or more PTL episodes could have had their PTD delayed beyond 35 weeks if a perfect tocolytic therapy had been available. Many pregnancies complicated by PTL occurred at > or =35 weeks or involved maternal or obstetric factors that contraindicated tocolytic medications. The maximum incremental benefit that could be expected of a new safe and efficacious tocolytic therapy would be to reduce current PTD rates resulting from PTL by about 12%.

Is diabetes treated as an acute or chronic illness in community family practice?

OBJECTIVE: Poor quality of diabetes care has been ascribed to the acute care focus of primary care practice. A better understanding of how time is spent during outpatient visits for diabetes compared with visits for acute conditions and other chronic diseases may facilitate the design of programs to enhance diabetes care. RESEARCH DESIGN AND METHODS: Research nurses directly observed consecutive outpatient visits during two separate days in 138 community family physician offices. Time use was categorized into 20 different behaviors using the Davis Observation Code (DOC). Time use was compared for visits for diabetes, other chronic conditions, and acute illnesses during 1,867 visits by patients > or =40 years of age. RESULTS: Of 20 DOC behavioral categories, 10 exhibited differences among the three groups. Discriminant analysis identified two distinct factors that distinguished visits for chronic disease from visits for acute illness and visits for diabetes from those for other chronic diseases. Compared with visits for other chronic diseases, visits for diabetes devoted a greater proportion of time to nutrition counseling, health education, and feedback on results and less time to chatting. Compared with visits for acute illness, visits for diabetes were longer and involved a higher proportion of dietary advice, negotiation, and assessment of compliance. CONCLUSIONS: Visits for diabetes are distinct from visits for other chronic diseases and acute illnesses in ways that may facilitate patient self-management. Novel quality-improvement interventions could support and expand existing differences between family physicians' current approaches to care of diabetes and other chronic and acute illnesses.

The Southeast Minnesota Fetal and Infant Mortality Reduction Project.

Using linked birth and death certificates, researchers collected information on the events surrounding and potentially contributing to all fetal and infant deaths in an 11-county southeast Minnesota area May 1, 1996, through May 31, 1998. Data were collected from medical record reviews and maternal interviews. Information was collated and presented to county review teams consisting of health, human services, and education personnel. These teams identified factors associated with potentially preventable deaths and gaps in services for women, infants, and families. A regional team then grouped and prioritized the factors.

Diagnosis and care of irritable bowel syndrome in a community-based population.

OBJECTIVE: To identify the healthcare utilization and evaluation in a community-based population with an incident diagnosis of irritable bowel syndrome (IBS). STUDY DESIGN: Retrospective cohort. PATIENTS: A randomly selected cohort of 149 Olmsted County, MN, adults with an incident diagnosis of IBS between June 1, 1992, and December 31, 1994. METHODS: Retrospective medical record review of each medical encounter for the 10 years before and the 3 years after the incident IBS diagnosis. Specific attention was given to healthcare visits, tests, and treatment associated with documented gastrointestinal (GI) tract symptoms and diagnosis of IBS. RESULTS: Of 149 patients, 98 (66%) were women, and the mean patient age was 46.6 years. Patients averaged 4.7 healthcare visits annually, including 0.5 related to GI tract symptoms. Two thirds of patients had GI tract symptom-related visits at least 2 years before IBS diagnosis. Only 5% of IBS diagnoses were made by a gastroenterologist. Colon examinations (colonoscopy or barium enema) were performed on 47% of patients and were more common in those aged > or = 55 years (58% vs 36%; P = .02). One third of patients had no GI tract testing proximal to the IBS diagnosis. Following the IBS diagnosis, only about half the patients made any IBS or GI tract symptom-related visits per year. CONCLUSION: The path to diagnosis of IBS is through the primary care physician and includes minimal testing and limited follow-up care.

The patient's perspective of irritable bowel syndrome.

OBJECTIVE: The researchers wanted to understand how irritable bowel syndrome (IBS) affects patients' lives and their interactions with physicians and the health care system. STUDY DESIGN: A qualitative study was performed using focus groups of people with physician-diagnosed IBS. Immersion/crystallization was used to identify overriding themes. POPULATION: Adult volunteers with a previous physician diagnosis of IBS were included. OUTCOMES MEASURED: The outcomes were patient-reported symptoms, episode triggers, treatments, lifestyle changes, and interactions with their physicians that were related to IBS, and overriding themes identified from the focus groups. RESULTS: The subjects described IBS as a chronic episodic illness that affects their daily lives. Interaction with the medical community seldom clarified understanding of the condition or improved its management. Three overriding themes emerged from the groups: a sense of frustration, a sense of isolation, and a search for a niche in the health/sick role continuum. Frustration was evident in the perceived inability to control symptoms, prevent episodes, identify episode triggers, and obtain medical validation of the condition. The constant anticipation of the next IBS episode, the need for immediate access to toilet facilities, and the nature of the bowel symptoms often required withdrawal from social activities and resultant isolation. CONCLUSIONS: IBS is perceived as a chronic condition resulting in frustration and social isolation, and physicians are perceived to be providing inadequate medical information or support to patients with IBS.

Do rural and urban children have comparable asthma care utilization?

This study compares asthma-related health care visits and drug therapy for rural and nonrural Kentucky children with Medicaid health insurance in 1995. The 8,634 children with asthma had a mean age of 5.7 years. Ninety-two percent made at least one asthma office visit, and 13 percent were hospitalized. The urban and rural patterns of care for childhood asthma varied in some potentially important ways. Urban children were twice as likely as rural children to see an asthma specialist (5 percent vs. 2.5 percent, P < 0.05), 2.7 times as likely to receive asthma care in an emergency department (19 percent vs. 7 percent, P < 0.01) and 1.4 times as likely to receive oral steroids (16 percent vs. 12 percent, P = 0.04). If given inhaled anti-inflammatory medication, rural children were more likely to receive inhaled steroids while urban children were more likely to receive cromoglycates.

Temporal changes in rates and reasons for medical induction of term labor, 1980-1996.

OBJECTIVE: This study was undertaken to assess temporal changes in rates and reasons for medical induction of term labor. STUDY DESIGN: A retrospective medical record review was conducted on a population-based cohort of 1293 women with term deliveries. RESULTS: The rate of medical labor induction increased from 12.9% in 1980 to 25.8% in 1995. Stated indications also changed, with a 2-fold increase in induction for postdate gestation, a 23-fold increase in induction for macrosomia, a 15-fold increase in elective induction, and a 22-fold decline in induction for premature rupture of membranes. The average gestational age at delivery of postdate pregnancies declined from 41.9 weeks in 1980 to 41.0 weeks in 1995. By 1995, the average maternal length of stay and the percentage of cesarean deliveries were higher among women with induced labor at term than among those with spontaneous labor at term. CONCLUSION: Induction of term labor has almost doubled in prevalence during the past 15 years. The most common indications are elective induction and postdate pregnancy, often applied to gestations of 40 to 41 weeks' duration.

Risk factors for deep vein thrombosis and pulmonary embolism during pregnancy or post partum: a population-based, case-control study.

OBJECTIVE: We sought to determine risk factors for deep vein thrombosis and pulmonary embolism during pregnancy or post partum. STUDY DESIGN: We performed a population-based case-control study. All Olmsted County, Minnesota, residents with a first lifetime deep vein thrombosis or pulmonary embolism during pregnancy or post partum from 1966 to 1990 were identified (N = 90). Where possible, a resident without deep vein thrombosis or pulmonary embolism was matched to each patient by date of the first live birth after the patient's child. The medical records of all remaining patients and all control subjects were reviewed for >25 baseline characteristics, which were tested as risk factors for deep vein thrombosis or pulmonary embolism. RESULTS: In multivariate analysis smoking (odds ratio, 2.4) and prior superficial vein thrombosis (odds ratio, 9.4) were independent risk factors for deep vein thrombosis or pulmonary thrombosis during pregnancy or post partum. CONCLUSION: Venous thromboembolism prophylaxis may be warranted for pregnant women with prior superficial vein thrombosis. Smoking cessation should be recommended, especially during pregnancy and the postpartum period.

Ovarian carcinoma: care and survival in a community-based population.

BACKGROUND: Previous studies of the management and costs of ovarian cancer have been based on data from oncology practices. Such studies may exclude patients who are not candidates for treatment and may not account for costs incurred during diagnosis or primary treatment. OBJECTIVE: The purpose of this study was to describe the epidemiology, management, and costs of care of ovarian cancer in a geographically defined population to better reflect the total spectrum of the disease and its care. METHODS: We conducted a retrospective review of the medical records of all residents of Olmsted County, Minnesota, who received a first diagnosis of epithelial ovarian carcinoma (including postmortem diagnoses) between 1985 and 1997. RESULTS: Of the 107 women with a new diagnosis of ovarian cacinoma, 42 (39%) had stage I or II tumors at the time of diagnosis. The mean age of the patients at the time of diagnosis was 64.7 years, and 20% were nulliparous. The diagnostic assessment for ovarian carcinoma was initiated by a family physician or internist in 50% of cases and by an obstetrician or gynecologist in 16% of cases. One hundred two patients (95%) underwent surgical treatment, and 80 (75%) received primary chemotherapy. The 5-year survival rate was 88% in those with stage I or II tumors and 17% in those with stage III or IV tumors. The mean charges for secondary care were higher than those for primary care ($36,110 vs $32,367; P < 0.05) in those receiving both types of therapy. Fifty percent of those dying of ovarian cancer received hospice care for a mean of 39.0 days before death. CONCLUSIONS: Most assessments leading to a diagnosis of ovarian carcinoma were initiated by primary care physicians. In this community-based population, early-stage and low-grade tumors were common (> or = 30%) and were associated with lower costs of care and higher 5-year survival rates. Total treatment costs for those requiring secondary therapy were approximately twice the costs for those requiring primary treatment only, with approximately 50% of costs associated with inpatient care.

Routine screening for postpartum depression.

BACKGROUND: Postpartum depression (PPD) is a common and often overlooked condition. Validated screening tools for PPD exist but are not commonly used. We present the 1-year outcome of a project to implement universal PPD screening at the 6-week postpartum visit. METHODS: Universal screening with the Edinburgh Postnatal Depression Scale (EPDS) was implemented in all community postnatal care sites. One-year outcome assessments (diagnosis and treatment of PPD) were completed for a sample of the women screened using medical record review of all care they received during the first year postpartum. RESULTS: Sixty-eight (20%) of the 342 women whose medical records were reviewed had been given a documented diagnosis of postpartum depression, resulting in an estimated population rate of 10.7%. Depression was diagnosed in 35% of the women with elevated EPDS scores (> or =10) compared with 5% of the women with low EPDS scores (<10) in the first year postpartum. Treatment was provided for all women diagnosed with depression, including drug therapy for 49% and counseling for 78%. Four women were hospitalized for depression. Some degree of suicidal ideation was noted on the EPDS by 48 women but acknowledged in the chart of only 10 women, including 1 with an immediate hospitalization. The rate of diagnosis of postpartum depression in this community increased from 3.7% before the routine use of EPDS screening to 10.7% following screening. CONCLUSIONS: A high EPDS score was predictive of a diagnosis of postpartum depression, and the implementation of routine EPDS screening at 6 weeks postpartum was associated with an increase in the rate of diagnosed postpartum depression in this community.