Centers for Disease Control and Prevention National Center for Health Statistics

The National Center for Health Statistics (NCHS) is responsible for administering various surveys at the national level. Some of these surveys are examined here.

National Health Interview Survey (NHIS)

This national survey provides information on the health of the US civilian population [65]. It is a cross-sectional survey with a multistage area probability design to achieve a representative sample of housholds. The questionnaire consists of basic health questions, demographics and current health questions. The CDRH used the 1988 Medical Device Supplement to the to the NHIS to provide prevalence of various implanted devices [66], such as artificial knees [67], internal orthopedic fixation devices [68], intraocular lenses [69], heart valves [70], pacemakers [71], aortic valves [72], breast implants [73], and tympanostomy tubes [74].

National Mortality Followback Survey (1993)

The Mortality Followback Program began in 1961 and was administered by the NCHS. The National Mortality Followback Survey (NMFS) collects additional information from a sample of US residents who die in a given year to supplement the death certificate with information from the next of kin or another person familiar with the decedent's personal history. The acquired information (from telephone or personal interviews conducted by trained field representatives of the US Bureau of the Census) provides an opportunity to study the etiology of disease, demographic trends, or other health issues [75,76]. In 1993, the NMFS included specific questions on the use of several medical devices. As part of the data collection, a study was conducted to evaluate the characteristics of persons aged 65 years or more who received an initial cardiac pacemaker during their final year of life. The goal of the study was to determine how prudently pacemakers were being utilized in this group. This analysis of NMFS data suggested that older persons who had initial pacemakers implanted during their final year of life were not terminally ill, inactive pacemaker candidates, in general, but relatively independent, physically functional candidates who frequently died abruptly. It appeared that the physical, mental, and life expectancy factors recommended for consideration by expert guidelines for the implantation of cardiac pacemakers were generally applied to persons in this group [76].

1988 NMIHS Survey

The 1988 National Maternal and Infant Health Survey (NMIHS) offered a unique opportunity to explore the relationship between birth outcomes and medical device use on a population-based nationally representative sample of births that occurred in 1988. It was unique because it contained extensive self-reported information about a woman's behaviors, her medical and obstetric history and child outcome linked to both the infant's birth certificate information and the medical and hospital records of her pregnancy and the post-partum period [77].

The 1988 NMIHS was conducted to study factors related to poor pregnancy outcomes in the USA. It drew stratified random samples from infant birth and death certificates and fetal death certificates in 48 states, the District of Columbia, and New York City that occurred in 1988. The final sample included three components: 9953 women who had live births; 5332 women who had infant deaths; and 3308 women who had late fetal deaths. Blacks were oversampled in all three components. Low-and very low-birthweight infants were oversampled in the birth component. An additional component included a Hispanics oversample from Texas, since a third of 1988 Texas births were to Hispanics. In 1988 there were 3 898 922 resident live births that were included in the sampling frame, 38 910 infant deaths, and approximately 15 000 late fetal deaths of 28 weeks or more gestation. Therefore, the overall probability of survey selection was 1 in every 354 live births, 1 in every 6 infant deaths and 1 in every 4 late fetal deaths. Data from the NMIHS were weighted to reflect national estimates. Content included in the 35-page questionnaire included: prenatal care and health habits; delivery; hospitalizations before and after delivery; previous and subsequent pregnancies; mother's and father's characteristics; family income; and baby's health. Questionnaires were also sent to up to seven prenatal care providers, the hospital of delivery, and three hospitals to which mother and baby were admitted before or after delivery. Data collected from hospital and provider questionnaires included all prenatal procedures (including an extensive list of medical device use), hospitalization for delivery, maternal hospitalization before and after delivery, and health status of infant, as well as infant rehospitalization after delivery. The completed NMIHS data link information from four sources: vital records (birth certificate, report of fetal death, infant death certificate); mothers' questionnaires; prenatal care providers' questionnaires; and hospital questionnaires. The CDRH used the NMIHS data to study the utilization of home pregnancy tests [78], electronic fetal monitoring and diagnostic ultrasound during pregnancy [79,80], and possible adverse events related to prenatal ultrasound [81].

National Healthcare Survey

The National Healthcare Survey (NHCS) is a combination of several healthcare provider surveys that collect information on healthcare services and characteristics of the patients served [82]. The following surveys are routinely administered: National Hospital Discharge Survey (NHDS) and National Survey of Ambulatory Surgery (NSAS) (the only medical device-related data are procedure codes) [83]; National Ambulatory Medical Care Survey (NAMCS) and National Hospital Ambulatory Medical Care Survey (NHAMCS) (the only medical device-related data are procedure codes) [84]; National Nursing Home Survey (NNHS) (includes data on assistive devices) [85]; and the National Home and Hospice Care Survey (NHHCS) (includes data on assistive devices) [86]. These surveys are based on a multistage sampling design that includes healthcare facilities or providers and patient records. Because the data are collected directly from providers, they provide more accurate and detailed data on diagnosis and treatment, as well as on the characteristics of the institutions. These surveys offer data for studying the impact of new medical technologies (including medical devices) changes and to monitor specific diseases/conditions and overall use of healthcare resources, within the tight limits of data available on medical device use.

The National Home and Hospice Care Survey (NHHCS)

A national probability sample survey of home health and hospice care agencies, this survey was first conducted by NHCS in 1992 and repeated in 1993 and 1994. The survey was fielded again in 1996, 1998, and most recently in 2000. The NHHCS was implemented as a result of changing trends in alternative sources of care for individuals and families facing long-term and end-of-life healthcare needs. In 2000, the sample consisted of about 1800 home health and hospice agencies and a sample of six current patient records and six discharged patient records from those agencies. The survey includes all types of agencies that provided home health and hospice care, regardless of whether they were Medicare or Medicaid. The data collected depict both the characteristics of these healthcare providers and the people they serve. Agency and patient items include, for example: type of ownership and affiliation; Medicare and Medicaid certification; patient demographics and functional status; diagnoses; services received; types of service providers; patient living arrangements and caregiver; expected sources of payment; and reason for discharge. Data are obtained through personal interviews with agency administrators and staff primarily responsible for the sampled patients' care. Respondents also refer to patient medical and other records, as necessary. In the past, CDRH has added questions to this survey to look at certain traditional medical devices that are being used in the home, such as ventilators, oxygenators, nebulizers, catheters, infusionpumps, blood glucose monitors, and restraints [86,87].

The general strength of the surveys is that they are population-based, which allows for national estimates of various health issues simultaneously. Another advantage of the surveys is that they can be linked with each other [87]. The major weaknesses of the surveys include high cost, length of the planning stage, and time lag. The use of the surveys to study medical devices is still limited to the most commonly used devices and those mentioned in the data.

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