The Burden of Work Productivity and Activity Impairment in Patients with Psoriasis, Psoriatic Arthritis, Ulcerative Colitis, and Crohn's Disease.

BACKGROUND: Comparisons among autoimmune diseases enable understanding of the burden and factors associated with work productivity loss and impairment. AIMS: The objective was to compare work productivity and activity and associated factors among patients with inflammatory bowel diseases and other autoimmune conditions. METHODS: This cross-sectional study included employed, adult patients (age 20-64 years) in the CorEvitas Inflammatory Bowel Disease, Psoriasis, and Psoriatic Arthritis/Spondyloarthritis Registries between 5/2017 and 6/2020. Any patient-reported impairment on four domains of the Work Productivity and Activity Index (WPAI) was collected across registries. Prevalence for each autoimmune disease was reported and stratified by disease activity using direct age-sex-standardization. Factors associated with the presence of any WPAI were identified in logistic regression models. RESULTS: A total of 7,169 patients with psoriasis (n = 4,768, 67%), psoriatic arthritis (n = 1,208, 17%), Crohn's disease (CD, n = 621, 9%), and ulcerative colitis (UC, n = 572, 8%) met inclusion criteria. Among patients not in remission across all disease cohorts, the age-sex-standardized prevalence of any presenteeism, work productivity loss, and activity impairment ranged from 54 to 97%. Patients with CD in remission had higher standardized prevalence of presenteeism (53% [48-57%]) and work productivity loss (54% [49-59%]), compared to those from other cohorts (presenteeism [range: 33-39%] and work productivity loss [range: 37-41%]). For all WPAI domains, the strongest adjusted associations were for moderate to severe disease activity and psychosocial symptoms. CONCLUSIONS: Patients with moderate to severe disease activity reported the highest WPAI burden. However, patients in remission or mild disease activity also report some WPAI burden, emphasizing a multidisciplinary treatment approach to improve work productivity loss and impairment.

Method used to identify adenomyosis and potentially undiagnosed adenomyosis in a large, U.S. electronic health record database.

BACKGROUND: The prevalence of adenomyosis is underestimated due to lack of a specific diagnostic code and diagnostic delays given most diagnoses occur at hysterectomy. OBJECTIVES: To identify women with adenomyosis using indicators derived from natural language processing (NLP) of clinical notes in the Optum Electronic Health Record database (2014-2018), and to estimate the prevalence of potentially undiagnosed adenomyosis. METHODS: An NLP algorithm identified mentions of adenomyosis in clinical notes that were highly likely to represent a diagnosis. The anchor date was date of first affirmed adenomyosis mention; baseline characteristics were assessed in the 12 months prior to this date. Characteristics common to adenomyosis cases were used to select a suitable pool of women from the underlying population, among whom undiagnosed adenomyosis might exist. A random sample of this pool was selected to form the comparator cohort. Logistic regression was used to compare adenomyosis cases to comparators; the predictive probability (PP) of being an adenomyosis case was assessed. Comparators having a PP ≥ 0.1 were considered potentially undiagnosed adenomyosis and were used to calculate the prevalence of potentially undiagnosed adenomyosis in the underlying population. RESULTS: Among 11 456 347 women aged 18-55 years in the underlying population, 19 503 were adenomyosis cases. Among 332 583 comparators, 22 696 women were potentially undiagnosed adenomyosis cases. The prevalence of adenomyosis and potentially undiagnosed adenomyosis was 1.70 and 19.1 per 1000 women aged 18-55 years, respectively. CONCLUSIONS: Considering potentially undiagnosed adenomyosis, the prevalence of adenomyosis may be 10x higher than prior estimates based on histologically confirmed adenomyosis cases only.

Using RWE research to extend clinical trials in diabetes: An example with implications for the future.

BACKGROUND: Although randomized, controlled trials (RCTs) are seen as the gold standard for evidence in clinical medicine, a number of considerations are increasing the use of real-world data (RWD) to generate evidence. A series of methodological challenges must be overcome in order for such real-world evidence (RWE) to gain acceptance. In diabetes, RWE faces some particular issues that have limited its development. As the natural history of diabetes progresses, patients' disease changes over time and treatments will be modified as a result. This evolving disease and treatment pattern requires application of methods that account for such changes over time. Research developing RWE in diabetes and other conditions has sometimes been subject to important biases, and researchers should be aware of, and take steps to mitigate potential for bias in order to enhance the evidence produced. RESULTS: We review a RWE study that replicated and extended evidence provided by a RCT regarding the effects of weekly exenatide relative to basal insulin (glargine or detemir) to illustrate a potential application of RWE. This study observed a 0.7% decrease in HbA1C for weekly exenatide relative to a 0.5% decrease in HbA1C for the comparator along with a 2 kg weight loss for weekly exenatide relative to a 0.25 kg weight gain, effects that were close to those from the RCT. Further, the RWE study was able to extend results to patient populations that were not well represented in the RCT. CONCLUSION: Despite numerous challenges, RWE can be used to complement evidence from RCTs.

Effectiveness and tolerability of therapy with exenatide once weekly vs basal insulin among injectable-drug-naïve elderly or renal impaired patients with type 2 diabetes in the United States.

AIM: To evaluate the effectiveness and tolerability of exenatide once weekly (EQW) compared with basal insulin (BI) among injectable-drug-naïve patients with type 2 diabetes mellitus (T2DM) who are elderly or have renal impairment (RI). MATERIALS AND METHODS: Initiators of EQW and BI with T2DM were identified for the period 2012 to 2015 within a US electronic health record database and matched by propensity score. Matched EQW and BI initiators aged ≥65 years or who had RI were compared. Data on weight, glycated haemoglobin (HbA1c), estimated glomerular filtration rate (eGFR), blood pressure and lipids were obtained at baseline and quarterly (Q1-Q4) or semi-annually for 1 year after drug initiation. Hypoglycaemia and gastrointestinal symptoms were identified using diagnosis codes and data abstracted from clinical notes. RESULTS: Among patients aged ≥65 years, HbA1c changed by -0.50 and -0.31 percentage points from baseline to Q4 for EQW and BI initiators, respectively. Weight changed by -1.6 kg among EQW initiators compared with 0.2 kg among BI initiators. Compared with BI initiators, EQW initiators had a 1.45-fold increased risk of nausea and vomiting. Among patients with RI, HbA1c changed by -0.58 and -0.33 percentage points from baseline to Q4 for EQW and BI initiators, respectively. Weight changed by -1.9 kg for EQW initiators while BI initiators had no change in weight. EQW initiators had a 1.28-fold increased risk of constipation and diarrhoea compared with BI initiators. CONCLUSION: Regardless of age or renal function, the benefits of EQW relative to BI treatment are improved glycaemic control and increased weight loss, which should be weighed against the increased risk of gastrointestinal symptoms.

Effectiveness and Tolerability of Therapy With Once-Weekly Exenatide Versus Basal Insulin Among Injectable-Naive Patients With Type 2 Diabetes in a Real-World Setting in the United States.

A propensity-matched cohort study compared injectable-naive patients with type 2 diabetes initiating exenatide once weekly (EQW) or basal insulin (BI), from 2012 through 2015, within a U.S. electronic health record database. A1C and weight were obtained as observed or multiply imputed values at baseline and quarterly for 1 year (Q1-Q4). Hypoglycemia and gastrointestinal symptoms were identified using diagnostic codes and clinical notes. EQW (n = 2,008) and BI (n = 4,016) cohorts were comparable at baseline (mean A1C and weight: EQW, 8.3% and 107.5 kg, respectively; BI, 8.5% and 107.9 kg, respectively). A1C declined in Q2: -0.69 and -0.50 percentage points for EQW and BI, respectively, with little further change in year 1. The EQW cohort lost 0.9 kg in Q1 and 1.9 kg by the end of the year; no weight change was observed in the BI cohort. Among EQW and BI cohorts, 25.9% and 14.3% achieved both glycemic control and weight loss, respectively. In the EQW and BI cohorts, the incidence of hypoglycemia per 1,000 person-years was 52.5 and 65.7, respectively. The incidence of nausea was greater among EQW relative to BI initiators (relative rate 1.18). EQW offers an advantage compared to BI in achieving glycemic control and weight loss and a lower incidence of hypoglycemia, but is associated with greater risk of gastrointestinal symptoms.

Tardive dyskinesia among patients using antipsychotic medications in customary clinical care in the United States.

BACKGROUND: Tardive dyskinesia (TD) is a movement disorder resulting from treatment with typical and atypical antipsychotics. An estimated 16-50% of patients treated with antipsychotics have TD, but this number may be underestimated. The objectives of this study were to build an algorithm for use in electronic health records (EHRs) for the detection and characterization of TD patients, and to estimate the prevalence of TD in a population of patients exposed to antipsychotic medications. METHODS: This retrospective observational study included patients identified in the Optum EHR Database who received a new or refill prescription for an antipsychotic medication between January 2011 and December 2015 (follow-up through June 2016). TD mentions were identified in the natural language-processed clinical notes, and an algorithm was built to classify the likelihood that the mention represented documentation of a TD diagnosis as probable, possible, unlikely, or negative. The final TD population comprised a subgroup identified using this algorithm, with ≥1 probable TD mention (highly likely TD). RESULTS: 164,417 patients were identified for the antipsychotic population, with1,314 comprising the final TD population. Conservatively, the estimated average annual prevalence of TD in patients receiving antipsychotics was 0.8% of the antipsychotic user population. The average annual prevalence may be as high as 1.9% per antipsychotic user per year, allowing for a more-inclusive algorithm using both probable and possible TD. Most TD patients were prescribed atypical antipsychotics (1049/1314, 79.8%). Schizophrenia (601/1314, 45.7%), and paranoid and schizophrenia-like disorders (277/1314, 21.1%) were more prevalent in the TD population compared with the entire antipsychotic drug cohort (13,308/164,417; 8.1% and 19,359/164,417; 11.8%, respectively). CONCLUSIONS: Despite a lower TD prevalence than previously estimated and the predominant use of atypical antipsychotics, identified TD patients appear to have a substantial comorbidity burden that requires special treatment and management consideration.

Implications for registry-based vaccine effectiveness studies from an evaluation of an immunization registry: a cross-sectional study.

BACKGROUND: Population-based electronic immunization registries create the possibility of using registry data to conduct vaccine effectiveness studies which could have methodological advantages over traditional observational studies. For study validity, the base population would have to be clearly defined and the immunization status of members of the population accurately recorded in the registry. We evaluated a city-wide immunization registry, focusing on its potential as a tool to study pertussis vaccine effectiveness, especially in adolescents. METHODS: We conducted two evaluations - one in sites that were active registry participants and one in sites that had implemented an electronic medical record with plans for future direct data transfer to the registry - of the ability to match patients' medical records to registry records and the accuracy of immunization records in the registry. For each site, records from current pediatric patients were chosen randomly. Data regarding pertussis-related immunizations, clinic usage, and demographic and identifying information were recorded; for 11-17-year-old subjects, information on MMR, hepatitis B, and varicella immunizations was also collected. Records were then matched, when possible, to registry records. For records with a registry match, immunization data were compared. RESULTS: Among 350 subjects from sites that were current registry users, 307 (87.7%) matched a registry record. Discrepancies in pertussis-related data were common for up-to-date status (22.6%), number of immunizations (34.7%), dates (10.2%), and formulation (34.4%). Among 442 subjects from sites that planned direct electronic transfer of immunization data to the registry, 393 (88.9%) would have matched a registry record; discrepancies occurred frequently in number of immunizations (11.9%), formulation (29.1%), manufacturer (94.4%), and lot number (95.1%.) Inability to match and immunization discrepancies were both more common in subjects who were older at their first visit to the provider site. For 11-17-year-old subjects, discrepancies were also common for MMR, hepatitis B, and varicella vaccination data. CONCLUSION: Provider records frequently could not be matched to registry records or had discrepancies in key immunization data. These issues were more common for older children and were present even with electronic data transfer. These results highlight general challenges that may face investigators wishing to use registry-based immunization data for vaccine effectiveness studies, especially in adolescents.

Psychological and behavioral correlates of entering care for HIV infection: the Antiretroviral Treatment Access Study (ARTAS).

The present study sought to examine psychological and behavioral variables as predictors of attending an HIV medical care provider among person's recently diagnosed with HIV. The study, carried out between 2001 and 2003, was a two-arm randomized intervention trial with participants recruited from public HIV testing centers, sexually transmitted disease (STD) clinics, hospitals, and community-based organizations in Atlanta, Georgia; Baltimore, Maryland; Miami, Florida; and Los Angeles, California. Eighty-six percent of those enrolled (273) had complete baseline and 12-month follow-up data. Measures of number of months since HIV diagnosis, readiness to enter care (based on stages of change), barriers and facilitators to entering care, drug use, and intervention arm (case managed versus simple referral) were examined as predictors of attending an HIV care provider, defined as being in care at least once in each of two consecutive 6-month follow-up periods. In logistic regression, seeing a care provider was significantly more likely among participants diagnosed with HIV within 6 months of enrollment (odds ratio [OR] = 2.52, 95% confidence interval [CI], 1.25, 5.06), those in the preparation versus precontemplation stages at baseline (OR = 2.87, 95% CI, 1.21, 6.81), those who reported at baseline that someone (friend, family member, social worker, other) was helping them get into care (OR = 2.13, 95% CI, 1.02, 4.44), and those who received a case manager intervention (OR = 2.16, 95% CI, 1.23, 3.78). The findings indicate a need to reach HIV-positive person's soon after diagnosis and assist them in getting into medical care. Knowing a person's stages of readiness to enter care and their support networks can help case managers formulate optimal client plans.

Tolerability and Effectiveness of Exenatide Once Weekly Relative to Basal Insulin Among Type 2 Diabetes Patients of Different Races in Routine Care.

INTRODUCTION: Analyses of efficacy and tolerability of pharmacologic interventions are based on clinical trials that often include predominately white populations, in part because of challenges associated with recruitment and retention of racial/ethnically diverse study populations. Using real-world electronic health record (EHR) data, we sought to evaluate the tolerability and effectiveness of exenatide once weekly (EQW), overall and relative to basal insulin (BI), according to race. METHODS: Patients with type 2 diabetes initiating EQW or BI between 2012 and 2015 were selected from the Optum EHR Research Database, a system pooling data from dozens of hospitals throughout the US. Measures of HbA1c, weight, and body mass index (BMI) were summarized at initiation and quarterly in the first year afterwards. Occurrences of gastrointestinal (GI) symptoms and hypoglycemia were identified by diagnostic codes and clinical notes, and incidence rates (IR) and relative rates (RR) were calculated. RESULTS: Overall, 4907 white patients (mean age = 57 years) and 454 African American patients (mean age = 53 years) were included. The percent change in HbA1c from initiation through 9-12 months was similar for white and African American patients [EQW-White: -6.89 (95% CI: -8.29, -5.50), EQW-African American: -5.99 (95% CI: -10.33, -1.65), BI-White: -4.68 (95% CI: -5.51, -3.86), BI-African American: -3.11 (95% CI: -5.37, -0.85)]. For EQW, percent change in weight was -1.73 (95% CI: -2.45, -1.02) for white patients and -1.11 (95% CI: -3.02, -0.81) for African American patients. No weight loss was observed among BI initiators. Relative to BI initiators, EQW initiators had lower rates of hypoglycemia [White RR: 0.82 (95% CI: 0.66, 1.01), African American RR: 0.59 (95% CI: 0.26, 1.34)]. GI symptoms were increased in white EQW initiators. CONCLUSIONS: Treatment with EQW, relative to BI, was associated with larger reductions in HbA1c and weight and reduced risk of hypoglycemia, effects that were not different for white and African American patients. FUNDING: AstraZeneca, Gothenburg, Sweden.

System and patient barriers to appropriate HIV care for disadvantaged populations: the HIV medical care provider perspective.

Little is known about the perception of system and patient barriers to adequate HIV care by an essential resource in the provision of HIV care, HIV medical care providers. To evaluate such perceptions, between November 2000 and June 2001 a survey was mailed to 526 HIV medical care providers who cared for HIV-infected individuals in Atlanta, Baltimore, Los Angeles, and Miami. Logistic regression analysis of survey results revealed significant differences in perceptions of system barriers between Black and Hispanic providers versus White providers and non-medical doctor providers versus medical doctor providers. Female providers differed significantly from male providers in assessing the importance of certain system and patient barriers. The authors observed that there are seeming disparities in perceptions of system and patient barriers to HIV medical care by providers of different race/ethnic groups, genders, and professions. More research needs to be conducted to determine if these disparities reflect differences in the provision of adequate HIV care for disadvantaged individuals.

Faster entry into HIV care among HIV-infected drug users who had been in drug-use treatment programs.

OBJECTIVE: We evaluated whether being in drug use treatment improves linkage to HIV medical care for HIV-infected drug users. We assessed whether an evidence-based intervention for linkage to care ['ARTAS'] works better for HIV-infected drug users who had been in drug use treatment than those who had not. DESIGN: Randomized trial. METHODS: 295 Participants in the Antiretroviral Treatment Access Study ['ARTAS'] trial were followed for time to first HIV medical care. Drug use (injected and non-injected drugs) in the last 30days and being in drug treatment in the last 12 months were assessed by audio-CASI. We used a proportional hazards model of time to care in drug users with and without drug treatment, adjusting for barriers to care, AIDS symptoms, and demographic factors. We tested whether drug treatment modified the intervention effect by using a drug use/drug treatment*intervention interaction term. RESULTS: Ninety-nine participants (30%) reported drug use in the 30days before enrollment. Fifty-three (18%) reported being in a drug treatment program in the last 12 months. Drug users reporting methadone maintenance became engaged in care in less than half the time of drug users without a treatment history [HR 2.97 (1.20, 6.21)]. The ARTAS intervention effect was significantly larger for drug users with a treatment history compared to drug users without a treatment history (AHR 5.40, [95% CI, 2.03-14.38]). CONCLUSIONS: Having been in drug treatment programs facilitated earlier entry into care among drug users diagnosed with HIV infection, and improved their response to the ARTAS linkage intervention.

Efficacy of a brief case management intervention to link recently diagnosed HIV-infected persons to care.

OBJECTIVE: The Antiretroviral Treatment Access Study (ARTAS) assessed a case management intervention to improve linkage to care for persons recently receiving an HIV diagnosis. METHODS: Participants were recently diagnosed HIV-infected persons in Atlanta, Baltimore, Los Angeles and Miami. They were randomized to either standard of care (SOC) passive referral or case management (CM) for linkage to nearby HIV clinics. The SOC arm received information about HIV and local care resources; the CM intervention arm included up to five contacts with a case manager over a 90-day period. The outcome measure was self-reported attendance at an HIV care clinic at least twice over a 12-month period. RESULTS: A higher proportion of the 136 case-managed participants than the 137 SOC participants visited an HIV clinician at least once within 6 months [78 versus 60%; adjusted relative risk (RR(adj)), 1.36; P = 0.0005) and at least twice within 12 months (64 versus 49%; RR(adj), 1.41; P = 0.006). Individuals older than 40 years, Hispanic participants, individuals enrolled within 6 months of an HIV-seropositive test result and participants without recent crack cocaine use were all significantly more likely to have made two visits to an HIV care provider. We estimate the cost of such case management to be 600-1200 US dollars per client. CONCLUSION: A brief intervention by a case manager was associated with a significantly higher rate of successful linkage to HIV care. Brief case management is an affordable and effective resource that can be offered to HIV-infected clients soon after their HIV diagnosis.

Seven valent pneumococcal conjugate vaccine immunization in two Boston communities: changes in serotypes and antimicrobial susceptibility among Streptococcus pneumoniae isolates.

BACKGROUND: Seven valent pneumococcal conjugate vaccine (PCV7) was licensed and introduced in 2000 for universal administration of children younger than 2 years of age and for selective immunization of children 2-5 years of age. SPECIFIC AIMS: To identify changes in colonization and antimicrobial susceptibility among Streptococcus pneumoniae organisms after introduction of PCV7. METHODS: Infants and children ages 2-24 months were enrolled in surveillance study of nasopharyngeal carriage of S. pneumoniae. Nasopharyngeal cultures for S. pneumoniae were performed at all well child visits and illness visits of children with acute otitis media. S. pneumoniae organisms were serotyped, and antimicrobial susceptibilities to penicillin, amoxicillin, trimethoprim-sulfamethoxazole and azithromycin were performed. RESULTS: During the 3-year period (October 2000 through September 2003), nasopharyngeal colonization with vaccine serotypes declined from 22% to 2%, and nonvaccine serotypes increased from 7% to 16%. Rates of antibiotic resistance of S. pneumoniae isolates to penicillin, amoxicillin, azithromycin and trimethoprim-sulfamethoxazole were 29.3, 2.2, 26.5 and 28.1%, respectively. CONCLUSIONS: PCV7 immunization produces a marked decline in vaccine serotypes carried in the nasopharynx of young children, with a coincident rise in the prevalence of nonvaccine serotypes. Important shifts in antimicrobial susceptibility have not been observed to date.

Direct and indirect effects of PCV13 on nasopharyngeal carriage of PCV13 unique pneumococcal serotypes in Massachusetts' children.

BACKGROUND: The direct impact of 13-valent pneumococcal conjugate vaccine (PCV13) on colonization with unique PCV13 serotypes and the uptake of vaccine necessary to create indirect protection in nonimmunized children were assessed. METHODS: Carriage surveillance among children <60 months began in July 2010 at a pediatric practice in Boston, MA. Children had nasopharyngeal cultures and parents completed questionnaires detailing demographics and health status. Concurrently, we monitored uptake of PCV13 in children in the community. Children were classified as "presumed immune" or "presumed nonimmune" based on age and PCV13 immunizations received. We assessed trends using adjusted prevalence rates calculated within rolling, 25-week, consecutive intervals. RESULTS: Between July 2010 and June 2012, 1050 S. pneumoniae isolates were recovered from 1042 children. Eighty-nine isolates (8.5%) were 1 of 6 unique PCV13 serotypes. The expected fall/winter peak in PCV13 carriage was observed in nonimmune children, but was blunted in immune children. There was a 74% reduction in PCV13 colonization in immune compared with nonimmune children. We document a 50% or more decline in the PCV13 carriage in nonimmune children, at the time when the approximately 75% or more of the community children had received PCV13 and were considered immune. During the study, the difference in PCV13 serotype colonization prevalence in nonimmune and immune children disappeared. No evidence of replacement has been observed to date. CONCLUSIONS: The direct impact of PCV13 on colonization was demonstrated. Evidence of indirect protection in unimmunized (nonimmune) children was observed as vaccine uptake reached 75% in the target community.

Prevalence and genetic diversity of nontypeable haemophilus influenzae in the respiratory tract of infants and primary caregivers.

BACKGROUND: Nontypeable Haemophilus influenzae (NTHi) causes otitis media, sinusitis, and likely lower respiratory tract infections in children. Colonization, strain diversity, transmission, and antimicrobial susceptibility have implications for both children and their caregivers. METHODS: For 13 months, we conducted a cross-sectional study of NTHi colonization. Upper respiratory tract cultures were performed in 273 infants and children 2 to 26 months of age and their primary caregivers. NTHi isolates were characterized by multilocus sequence typing (MLST), and antibiotic resistance was examined. RESULTS: Of the 273 infants, 44 (16.1%) were colonized with NTHi. Prevalence of NTHi varied from 14% in infants less than 6 months of age to 32% in infants between 19 and 26 months of age (P = 0.003). NTHi-colonized infants were more likely to attend day care (30% vs. 12%), have a recent respiratory infection (68% vs. 38%), have recently taken an antibiotic (27% vs. 9%), and have a primary caregiver who reported asthma (11% vs. 1%), compared with other infants (P < 0.01). In the 44 infants colonized with NTHi, we identified 33 different MLSTs. Of the 44 infant-primary caregiver dyads, 9 (20.5%) were colonized with NTHi, and 7 of these 9 shared identical NTHi strains. We also found beta-lactamase-negative NTHi with minimum inhibitory concentrations >2 µg/mL for amoxicillin and beta-lactamase-positive NTHi with minimum inhibitory concentrations >2 µg/mL for amoxicillin clavulanate. CONCLUSIONS: We found substantial diversity by MLST analysis among NTHi isolates from this community. Infant-primary caregiver dyads usually carried the same strain of NTHi, suggesting that infant-primary caregiver transmission is occurring.

Causality assessment of adverse events reported to the Vaccine Adverse Event Reporting System (VAERS).

UNLABELLED: Adverse events following immunization (AEFI) reported to the national Vaccine Adverse Event Reporting System (VAERS) represent true causally related events, as well as events that are temporally, but not necessarily causally related to vaccine. OBJECTIVE: We sought to determine if the causal relationships between the vaccine and the AEFI reported to VAERS could be assessed through expert review. DESIGN: A stratified random sample of 100 VAERS reports received in 2004 contained 13 fatal cases, 19 cases with non-fatal disabilities, 39 other serious non-fatal cases and 29 non-serious cases. Experts knowledgeable about vaccines and clinical outcomes, reviewed each VAERS report and available medical records. MAIN OUTCOME MEASURES: Modified World Health Organization criteria were used to classify the causal relationship between vaccines and AEFI as definite, probable, possible, unlikely or unrelated. Five independent reviewers evaluated each report. If they did not reach a majority agreement on causality after initial review, the report was discussed on a telephone conference to achieve agreement. RESULTS: 108 AEFIs were identified in the selected 100 VAERS reports. After initial review majority agreement was achieved for 83% of the AEFI and 17% required further discussion. In the end, only 3 (3%) of the AEFI were classified as definitely causally related to vaccine received. Of the remaining AEFI 22 (20%) were classified as probably and 22 (20%) were classified as possibly related to vaccine received; a majority (53%) were classified as either unlikely or unrelated to a vaccine received. CONCLUSIONS: Using VAERS reports and additional documentation, causality could be assessed by expert review in the majority of VAERS reports. Assessment of VAERS reports identified that causality was thought to be probable or definite in less than one quarter of reports, and these were dominated by local reactions, allergic reactions, or symptoms known to be associated with the vaccine administered.

Evaluation of a rapid qualitative enzyme chromatographic test for glucose-6-phosphate dehydrogenase deficiency.

Rapid determination of glucose-6-phosphate dehydrogenase (G6PD) status is desirable when it is necessary to use a drug contraindicated in G6PD-deficient persons, such as use of primaquine for malaria prevention or treatment. The purpose of this study was to compare a new, rapid, qualitative enzyme chromatographic test for deficiency of G6PD to a standard reference method. Samples from 196 G6PD-normal persons and 50 G6PD-deficient persons were evaluated. The sensitivity of the experimental rapid test was 0.98 and the specificity was 0.98 using specimens preserved in heparin, and 0.98 and 0.97, respectively, for specimens preserved in EDTA. Positive and negative predictive values were 0.72 and 1.00, respectively, for the test for heparinized specimens and 0.65 and 1.00, respectively, for the EDTA-preserved samples. This rapid test for G6PD deficiency is a sensitive method for screening of G6PD deficiency that requires minimal training and equipment and enables rapid identification of G6PD-deficient persons.

Perceptions of human immunodeficiency virus (HIV) testing services among HIV-positive persons not in medical care.

BACKGROUND AND OBJECTIVES: Human immunodeficiency virus (HIV) counseling, testing, and referral (CTR) are provided in a wide variety of settings. GOAL: To compare, by test setting, the perceptions of the testing experience among HIV-positive persons who were not receiving medical care. DESIGN: A baseline questionnaire was administered at enrollment into the Antiretroviral Treatment Access Study by the use of audio computer-assisted self-interview. RESULTS: Of 316 respondents, 27% reported that the counselor did not spend enough time with them and 22% that the counselor did not answer all questions. The odds were higher that persons in the following settings, compared with those at HIV test sites, would report that the counselor did not spend enough time with them: office of private physician or health maintenance organization (HMO) (adjusted odds ratio [AOR], 5.24; 95% confidence interval, 1.26-21.7), jail (AOR, 5.10; 95% CI, 1.06-24.6), and emergency room (ER) or hospital overnight visit (AOR, 2.93; 95% CI, 1.15-7.44). Similarly, the odds were higher that persons in the following settings compared with those at HIV test sites would report that the counselor did not answer all questions: office of private physician or HMO (AOR, 9.62; 95% CI, 2.22-41.7), jail (AOR, 7.87; 95% CI, 1.50-41.4), and ER or hospital overnight visit (AOR, 3.32; 95% CI, 1.11-9.90). CONCLUSION: Further training and quality assurance in HIV CTR may be needed in some test settings.

Test-retest reliability of a complex human immunodeficiency virus research questionnaire administered by an Audio Computer-assisted Self-interviewing system.

OBJECTIVES: To evaluate the test-retest reliability of a complex questionnaire administered by Audio Computer-assisted Self-interviewing to recently diagnosed human immunodeficiency virus-positive patients. METHODS: Thirty-seven English-speaking and 32 Spanish-speaking participants completed both test and retest interviews. Pearson correlation coefficients (r) and kappa (kappa) and weighted kappa (kappa) statistics were obtained for individual questions. From these, overall kappa and Pearson correlation coefficients were calculated across all variables and for groups of questions. RESULTS: Overall measures of reliability were kappa = 0.767, r = 0.728. Some variation in reliability existed for different response formats, question content groups, and languages of the participants. Differences in overall reliability by Spanish compared with English participants were small and not statistically significant. CONCLUSIONS: Audio Computer-assisted Self-interviewing provides reliable measures for items assessed in the Antiretroviral Treatment and Access Study baseline questionnaire. Some differences exist as a result of question content, interview language, and response format, requiring assessment in future studies and consideration in designing Audio Computer-assisted Self-interviewing systems and questionnaires.