Protocol for a national probability survey using home specimen collection methods to assess prevalence and incidence of SARS-CoV-2 infection and antibody response.

PURPOSE: The U.S. response to the SARS-CoV-2 epidemic has been hampered by early and ongoing delays in testing for infection; without data on where infections were occurring and the magnitude of the epidemic, early public health responses were not data-driven. Understanding the prevalence of SARS-CoV-2 infections and immune response is critical to developing and implementing effective public health responses. Most serological surveys have been limited to localities that opted to conduct them and/or were based on convenience samples. Moreover, results of antibody testing might be subject to high false positive rates in the setting of low prevalence of immune response and imperfect test specificity. METHODS: We will conduct a national serosurvey for SARS-CoV-2 PCR positivity and immune experience. A probability sample of U.S. addresses will be mailed invitations and kits for the self-collection of anterior nares swab and finger prick dried blood spot specimens. Within each sampled household, one adult 18 years or older will be randomly selected and asked to complete a questionnaire and to collect and return biological specimens to a central laboratory. Nasal swab specimens will be tested for SARS-CoV-2 RNA by RNA PCR; dried blood spot specimens will be tested for antibodies to SARS-CoV-2 (i.e., immune experience) by enzyme-linked immunoassays. Positive screening tests for antibodies will be confirmed by a second antibody test with different antigenic basis to improve predictive value of positive (PPV) antibody test results. All persons returning specimens in the baseline phase will be enrolled into a follow-up cohort and mailed additional specimen collection kits 3 months after baseline. A subset of 10% of selected households will be invited to participate in full household testing, with tests offered for all household members aged ≥3 years. The main study outcomes will be period prevalence of infection with SARS-CoV-2 and immune experience, and incidence of SARS-CoV-2 infection and antibody responses. RESULTS: Power calculations indicate that a national sample of 4000 households will facilitate estimation of national SARS-CoV-2 infection and antibody prevalence with acceptably narrow 95% confidence intervals across several possible scenarios of prevalence levels. Oversampling in up to seven populous states will allow for prevalence estimation among subpopulations. Our 2-stage algorithm for antibody testing produces acceptable PPV at prevalence levels ≥1.0%. Including oversamples in states, we expect to receive data from as many as 9156 participants in 7495 U.S. households. CONCLUSIONS: In addition to providing robust estimates of prevalence of SARS-CoV-2 infection and immune experience, we anticipate this study will establish a replicable methodology for home-based SARS-CoV-2 testing surveys, address concerns about selection bias, and improve positive predictive value of serology results. Prevalence estimates of SARS-CoV-2 infection and immune experience produced by this study will greatly improve our understanding of the spectrum of COVID-19 disease, its current penetration in various demographic, geographic, and occupational groups, and inform the range of symptoms associated with infection. These data will inform resource needs for control of the ongoing epidemic and facilitate data-driven decisions for epidemic mitigation strategies.

Predictors of Adverse Events and Medical Errors Among Adult Inpatients of Psychiatric Units of Acute Care General Hospitals.

OBJECTIVE: The aim of this study was to identify factors associated with the occurrence of adverse events (AEs) or medical errors (MEs) during inpatient psychiatric hospitalizations. METHODS: A full-probability random sample of 4,371 charts from 14 inpatient psychiatric units at acute care general hospitals in Pennsylvania were reviewed in a two-stage process that comprised screening and flagging by nurses followed by review by psychiatrists. AE and ME rates were calculated overall and then stratified by patient and hospital factors. Unadjusted and adjusted logistic regression models examined predictors of AEs and MEs. RESULTS: An AE was identified in 14.5% of hospitalizations (95% confidence interval [CI]=11.7-17.9), and an ME was identified in 9.0% (CI=7.5-11.0). In adjusted analyses, patients with a longer length of stay and older patients had higher odds of experiencing an AE or an ME. Patients ages 31-42 (compared with ages 18-30), with commercial insurance (compared with Medicare or Medicaid or uninsured), or treated at high-volume hospitals (compared with low, medium, or very high) had lower odds of an AE. Patients age 54 or older (compared with ages 18-30), admitted during the weekend, admitted to rural hospitals (compared with urban), or treated at very-high-volume hospitals (compared with high) were more likely to experience an ME. CONCLUSIONS: This study provides insight into factors that put patients and hospitals at increased risk of patient safety events. This information can be used to tailor improvement strategies that enhance the safety of patients treated on general hospital psychiatric units.

Safety of Psychiatric Inpatients at the Veterans Health Administration.

OBJECTIVE: Although reducing adverse events and medical errors has become a central focus of the U.S. health care system over the past two decades both within and outside the Veterans Health Administration (VHA) hospital systems, patients treated in psychiatric units of acute care general hospitals have been excluded from major research in this field. METHODS: The study included a random sample of 40 psychiatric units from medical centers in the national VHA system. Standardized abstraction tools were used to assess the electronic health records from 8,005 hospitalizations. Medical record administrators screened the records for the presence of ten specific types of patient safety events, which, when present, were evaluated by physician reviewers to assess whether the event was the result of an error, whether it caused harm, and whether it was preventable. RESULTS: Approximately one in five patients experienced a patient safety event. The most frequently occurring events were medication errors (which include delayed and missed doses) (17.2%), followed by adverse drug events (4.1%), falls (2.8%), and assault (1.0%). Most patient safety events (94.9%) resulted in little harm or no harm, and more than half (56.6%) of the events were deemed preventable. CONCLUSIONS: Although patient safety events in VHA psychiatric inpatient units were relatively common, a great majority of these events resulted in little or no patient harm. Nevertheless, many were preventable, and the study provides data with which to target future initiatives that may improve the safety of this vulnerable patient population.

Rationale, design and respondent characteristics of the 2013-2014 New York City Health and Nutrition Examination Survey (NYC HANES 2013-2014).

PURPOSE: Capacity to monitor non-communicable diseases (NCDs) at state or local levels is limited. Emerging approaches include using biomeasures and electronic health record (EHR) data. In 2004, New York City (NYC) performed a population-based health study on adult residents using biomeasures (NYC Health and Nutrition Examination Study, or NYC HANES), modeled after NHANES. A second NYC HANES was launched in 2013 to examine change over time, evaluate municipal policies, and validate a proposed EHR-based surveillance system. We describe the rationale and methods of NYC HANES 2013-2014. METHODS: NYC HANES was a population-based, cross-sectional survey of NYC adults using three-stage cluster sampling. Between August 2013 and June 2014, selected participants completed a health interview and physical exam (blood pressure, body mass index, and waist circumference). Fasting biomeasures included diabetes, lipid profiles, kidney function, environmental biomarkers, and select infectious diseases. RESULTS: Of the 3065 households approached, 2742 were eligible and 1827 were successfully screened (67%). A total of 1524 of eligible participants completed the survey (54%), for an overall response rate of 36%. CONCLUSION: Completing a second NYC HANES a decade after the first study affords an opportunity to understand changes in prevalence, awareness and control of NCDs and evaluate municipal efforts to manage them.

A probability sample for monitoring the HIV-infected population in care in the U.S. and in selected states.

Epidemiologic and clinical changes in the HIV epidemic over time have presented a challenge to public health surveillance to monitor behavioral and clinical factors that affect disease progression and HIV transmission. The Medical Monitoring Project (MMP) is a supplemental surveillance project designed to provide representative, population-based data on clinical status, care, outcomes, and behaviors of HIV-infected persons receiving care at the national level. We describe a three-stage probability sampling method that provides both nationally and state-level representative estimates.In stage-I, 20 states, which included 6 separately funded cities/counties, were selected using probability proportional to size (PPS) sampling. PPS sampling was also used in stage-II to select facilities for participation in each of the 26 funded areas. In stage-III, patients were randomly selected from sampled facilities in a manner that maximized the possibility of having overall equal selection probabilities for every patient in the state or city/county. The sampling methods for MMP could be adapted to other research projects at national or sub-national levels to monitor populations of interest or evaluate outcomes and care for a range of specific diseases or conditions.

When data are not missing at random: implications for measuring health conditions in the Behavioral Risk Factor Surveillance System.

OBJECTIVES: To examine the effect on estimated levels of health conditions produced from large-scale surveys, when either list-wise respondent deletion or standard demographic item-level imputation is employed. To assess the degree to which further bias reduction results from the inclusion of correlated ancillary variables in the item imputation process. DESIGN: Large cross-sectional (US level) household survey. PARTICIPANTS: 218 726 US adults (18 years and older) in the 2006 Behavioral Risk Factor Surveillance System Survey. This survey is the largest US telephone survey conducted by the Centers for Disease Control and Prevention. PRIMARY AND SECONDARY OUTCOME MEASURES: Estimated rates of severe depression among US adults. RESULTS: The use of list-wise respondent deletion and/or demographic imputation results in the underestimation of severe depression among adults in the USA. List-wise deletion produces underestimates of 9% (8.7% vs 9.5%). Demographic imputation produces underestimates of 7% (8.9% vs 9.5%). Both of these differences are significant at the 0.05 level. CONCLUSION: The use of list-wise deletion and/or demographic-only imputation may produce significant distortion in estimating national levels of certain health conditions.

Time to first annual HIV care visit and associated factors for patients in care for HIV infection in 10 US cities.

BACKGROUND: Visiting a medical provider less frequently than clinical circumstances would suggest is appropriate has been reported to be associated with worse clinical outcomes for patients living with HIV infection. Patients with less frequent attendance to HIV care also may be systematically underrepresented in research or surveillance studies that enroll patients sequentially over a specified enrollment period - for example several months. For both reasons, understanding factors associated with time to care visit is important. METHODS: We used data from the Adult and Adolescent Spectrum of HIV Disease (ASD) project, a multi-site clinical outcomes surveillance system that enrolled and followed patients in care for HIV prospectively from 1990 to 2004. For this analysis, we used data from all patients observed in ASD at least one time before 1 January 2003, and who had at least one HIV care visit in 2003. We documented time to first annual HIV care visit for each patient, and used Kaplan-Meier plots and proportional hazards regression to describe factors associated with longer time to care visit. RESULTS: A total of 12,135 patients had ≥1 care visit during 2003 and were included in the analysis. Of these, 81%, 88%, and 95% had their first visit within three, four, and six months, respectively. In multivariate analysis, having a delayed (later) care visit was associated with not ever having had an AIDS diagnosis, having an HIV RNA concentration ≥10,000 copies/mL, having a current CD4 count <100 cells/µL, having no health insurance, and not being currently prescribed antiretroviral therapy. Having a delayed care visit was not associated with race/ethnicity or age. CONCLUSIONS: Having a delayed first annual HIV care visit was associated with higher viremia, lower CD4 cell count, and lack of health insurance. Interventions to address these factors are likely to ameliorate some of the consequences of HIV. For studies enrolling patients in care for HIV over a finite time period, an enrollment period of four-six months should sufficiently reflect the patient population seen in a one-year period, including those attending care infrequently.

Improving public health surveillance using a dual-frame survey of landline and cell phone numbers.

To meet challenges arising from increasing rates of noncoverage in US landline-based telephone samples due to cell-phone-only households, the Behavioral Risk Factor Surveillance System (BRFSS) expanded a traditional landline-based random digit dialing survey to a dual-frame survey of landline and cell phone numbers. In 2008, a survey of adults with cell phones only was conducted in parallel with an ongoing landline-based health survey in 18 states. The authors used the optimal approach to allocate samples into landline and cell-phone-only strata and used a new approach to weighting state-level landline and cell phone samples. They developed logistic models for each of 16 health indicators to examine whether exclusion of adults with cell phones only affected estimates after adjustment for demographic characteristics. The extents of the potential biases in landline telephone surveys that exclude cell phones were estimated. Biases resulting from exclusion of adults with cell phones only from the landline-based survey were found for 9 out of the 16 health indicators. Because landline noncoverage rates for adults with cell phones only continue to increase, these biases are likely to increase. Use of a dual-frame survey of landline and cell phone numbers assisted the BRFSS efforts in obtaining valid, reliable, and representative data.

Design and operation of the National Asthma Survey.

OBJECTIVES: This report presents detailed information on the National Asthma Survey (NAS), a module of the State and Local Area Integrated Survey program conducted by the Centers for Disease Control and Prevention's (CDC) National Center for Health Statistics. NAS, sponsored by the CDC's National Center for Environmental Health, was designed to produce national prevalence estimates of adults and children with asthma; to describe the health, socioeconomic, behavioral, and environmental predictors that relate to controlling asthma better; and to characterize the content of care and limitations of persons with asthma. National prevalence estimates were constructed to be consistent with those produced from the CDC's National Health Interview Survey (NHIS), although prevalence estimates for subpopulations may or may not be consistent with NHIS. METHODS: Two separate random-digit-dial telephone studies were fielded: a national study and a four-state study in Alabama, California, Illinois, and Texas. Children aged 0-17 years and adults aged 18 years and over were included in both studies. The screening procedure differed between the studies. Percentages can be generated for the four states combined or for each state separately. A substudy was conducted in the national study to examine the accuracy of proxy reports of asthma. RESULTS: Data were collected from February 2003 to March 2004. A total of 955 detailed asthma interviews were completed in the national study and 5,741 in the four-state study. A data file has been released for each study that contains asthma, health, and demographic data, as well as sampling weights. The weighted overall response rates were 47.2% for the national sample and 48.5% for the four-state sample.

Address-based versus random-digit-dial surveys: comparison of key health and risk indicators.

Use of random-digit dialing (RDD) for conducting health surveys is increasingly problematic because of declining participation rates and eroding frame coverage. Alternative survey modes and sampling frames may improve response rates and increase the validity of survey estimates. In a 2005 pilot study conducted in six states as part of the Behavioral Risk Factor Surveillance System, the authors administered a mail survey to selected household members sampled from addresses in a US Postal Service database. The authors compared estimates based on data from the completed mail surveys (n = 3,010) with those from the Behavioral Risk Factor Surveillance System telephone surveys (n = 18,780). The mail survey data appeared reasonably complete, and estimates based on data from the two survey modes were largely equivalent. Differences found, such as differences in the estimated prevalences of binge drinking (mail = 20.3%, telephone = 13.1%) or behaviors linked to human immunodeficiency virus transmission (mail = 7.1%, telephone = 4.2%), were consistent with previous research showing that, for questions about sensitive behaviors, self-administered surveys generally produce higher estimates than interviewer-administered surveys. The mail survey also provided access to cell-phone-only households and households without telephones, which cannot be reached by means of standard RDD surveys.

Adult tobacco use levels after intensive tobacco control measures: New York City, 2002-2003.

OBJECTIVES: We sought to determine the impact of comprehensive tobacco control measures in New York City. METHODS: In 2002, New York City implemented a tobacco control strategy of (1) increased cigarette excise taxes; (2) legal action that made virtually all work-places, including bars and restaurants, smoke free; (3) increased cessation services, including a large-scale free nicotine-patch program; (4) education; and (5) evaluation. The health department also began annual surveys on a broad array of health measures, including smoking. RESULTS: From 2002 to 2003, smoking prevalence among New York City adults decreased by 11% (from 21.6% to 19.2%, approximately 140000 fewer smokers). Smoking declined among all age groups, race/ethnicities, and education levels; in both genders; among both US-born and foreign-born persons; and in all 5 boroughs. Increased taxation appeared to account for the largest proportion of the decrease; however, between 2002 and 2003 the proportion of cigarettes purchased outside New York City doubled, reducing the effective price increase by a third. CONCLUSIONS: Concerted local action can sharply reduce smoking prevalence. However, further progress will require national action, particularly to increase cigarette taxes, reduce cigarette tax evasion, expand education and cessation services, and limit tobacco marketing.

Design and Operation of the National Survey of Children's Health, 2003.

Objectives-This report presents the development, plan, and operation of the National Survey of Children's Health(NSCH), a module of the State and Local Area Integrated Telephone Survey, conducted by the Centers for Disease Control and Prevention's(CDC) National Center for Health Statistics. This survey was designed to produce national and State-specific prevalence estimates for a variety of physical, emotional, and behavioral health indicators and measures of children's experiences with the health care system. The survey also includes questions about the family (e.g., parents' health status, stress and coping behaviors, family activities) and about respondents' perceptions of the neighborhoods where their children live. Primary funding for this survey was provided by the Maternal and Child Health Bureau, Health Resources and Services Administration. Additional support was received from the CDC's National Center for Infectious Diseases, using funds provided by the National Vaccine Program Office. Methods-A random-digit-dial sample of households with children under 18 years of age was selected from each of the 50 States and the District of Columbia. One child was randomly selected from all children in each identified household to be the subject of the survey. The respondent was the parent or guardian who knew the most about the child's health and health care. Results-A total of 102,353 interviews were completed from January 2003 to July 2004. The weighted overall response rate was 55.3%. A data file has been released that contains demographic information on the selected child, substantive health and well-being data for the child and his/her family, and sampling weights. Estimates based on the sampling weights generalize to the noninstitutionalized population of children in each State and nationwide.

Estimating the prevalence of uninsured children: an evaluation of data from the National Survey of Children with Special Health Care Needs, 2001. Data evaluation and methods research.

UNLABELLED: The National Survey of Children with Special Health Care Needs revealed that 8.3% of children under 18 years of age were uninsured, a rate lower than the rate estimated by other national surveys. This report presents the results of an evaluation of the quality of this estimate, based on analyses of non-response, question design, interviewer and respondent effects, and the weighing and estimation process. National and State-level statistics on health insurance coverage for children with special health care needs (CSHCN) and for children without special needs are included in an appendix. SOURCE OF DATA: The National Survey of CSHCN is a survey module of the State and Local Area Integrated Telephone Survey. This survey of parents and guardians collected health insurance coverage information for a national sample of 215, 162 children. Data were collected from October 2000 through April 2002. RESULTS: Compared with other surveys, weighted data from the National Survey of CSHCN describe a population with a slightly larger proportion of Hispanic children and children from households with higher incomes. The National Survey of CSHCN was also the only survey to use a child-level design: A randomized experiment that varied the health insurance questions found that repeating the coverage questions for each child produced lower unisurance rates than household-level questions that first asked if anyone in the househol was insured. CONCLUSION: Question design differences explain much of the discrepancy between survey estimates of the uninsurance rate, but a definitive conclusion regarding the relative accuracy of the uninsurance rates is not possible.

Design and operation of the National Survey of Children with Special Health Care Needs, 2001.

OBJECTIVES: This report presents the development, plan, and operation of the National Survey of Children with Special Health Care Needs (CSHCN), a module of the State and Local Area Integrated Telephone Survey, conducted by the National Center for Health Statistics, Centers for Disease Control and Prevention. This survey was designed to produce national and State-specific prevalence estimates of CSHCN, describe the types of services that they need and use, and assess aspects of the system of care for CSHCN. This study included two additional modules to provide health care coverage estimates for all children and to collect data on the reasons that low-income uninsured children lack health care coverage. Primary funding for this survey was provided by the Maternal and Child Health Bureau, Health Resources and Services Administration. METHODS: A random-digit-dial sample of households with children under 18 years of age was selected from each of the 50 States and the District of Columbia. Depending on the health care needs of the children in each household, a detailed interview was conducted for one randomly selected child with special needs and a brief health insurance interview was conducted for one randomly selected child without special needs. The respondent was the parent or guardian who knew the most about the child's health and health care. RESULTS: A total of 196,888 household screening interviews were completed from October 2000 to April 2002. This resulted in 38,866 completed special-needs interviews and 176,296 completed health insurance interviews for children without special needs. The weighted overall response rate for special-needs interviews was 61.0%.

Adjustments for non-telephone bias in random-digit-dialling surveys.

Telephone surveys are widely used in the U.S.A. for the study of health-related topics. They are subject to 'coverage bias' because they cannot sample households that do not have telephones. Although only around 5 per cent of households do not have a telephone, rates of telephone coverage show substantial variation by geography, demographic factors and socio-economic factors. In particular, lack of telephone service is more common among households that contain ethnic and racial minorities or that have lower socio-economic status with fewer opportunities for access to medical care and poorer health outcomes. Thus, failure to adequately account for households without telephones in health surveys may yield estimates of health outcomes that are misleading, particularly in states with at least moderate telephone non-coverage. The dynamic nature of the population of households without telephones offers a way of accounting for such households in telephone surveys. At any given time the population of telephone households includes households that have had a break or interruption in telephone service. Empirical results strongly suggest that these households are very similar to households that have never had telephone service. Thus, sampled households that report having had an interruption in telephone service may be used also to represent the portion of the population that has never had telephone service. This strategy can lead to a reduction in non-coverage bias in random-digit-dialling surveys. This paper presents two methods of adjusting for non-coverage of non-telephone households. The effectiveness of these methods is examined using data from the National Health Interview Survey. The interruption-in-telephone-service methods reduce non-coverage bias and can also result in a lower mean squared error. The application of the interruption-in-telephone-service methods to the National Immunization Survey is also discussed. This survey produces estimates for the 50 states and 28 urban areas. The interruption-in-telephone-service estimates tend be slightly lower than estimates resulting from poststratification and from another non-coverage adjustment method. The results suggest that the reduction in bias is greatest for variables that are highly correlated with the presence or absence of telephone service.