CaliforniaHealthInterviewSurvey2007_2-7-07_sectA[1]

California Health Interview Survey 2007

Cancer Control Module

Supporting Statement

Nancy Breen,

Project Officer

Applied Research Program

Division of Cancer Control and Population Sciences

National Cancer Institute

6103 Executive Blvd.

Bethesda, MD 20892

breenn@mail.nih.gov

Phone: 301-496-8500

FAX: 301-435-3710

Section A

Introduction

A: JUSTIFICATION

A.1. Circumstances Requiring the Collection of Data

              

 The Applied Research Program (ARP), Division of Cancer Control and Population Sciences (DCCPS), National Cancer Institute (NCI), has contracted with the Center for Health Policy Research, University of California Los Angeles (UCLA), for a 2-year period to conduct a statewide health survey entitled the California Health Interview Survey (CHIS) 2007 Cancer Control Module (CCM). The CCM module will be a component of the CHIS, which is a public-private collaborative effort of the UCLA Center for Health Policy Research (UCLA CHPR), the private non-profit California Public Health Institute (PHI), and the California Department of Health Service (CDHS).

The CHIS 2007 CCM is the fourth biennial CHIS survey sponsored by the ARP. The first survey was the 2000 CHIS CCM (2000 CHIS CCM, OMB No. 0925-0478, Federal Register, May 8, 2000, Vol. 65, No. 89, p. 26620). Because the majority of the data collection for the 2000 CHIS-CCM actually took place in 2001, the 2000 CHIS-CCM will henceforth be referred to as CHIS 2001 CCM, The second survey took place in 2003 (2003 CHIS CCM, OMB No. 0925-0518, Federal Register: October 3, 2002, Volume 67, Number 192, pp. 62067-62068) and the third in 2005 (2005 CHIS CCM, OMB No. 0925-0000, Federal Register, Vol. 69, 150, Aug. 5, 2004, pp. 47450-47451, and Federal Register, Vol. 70, No. 1, Jan. 3, 2005, pp. 93-94). 

The CHIS, a Random Digit Dial (RDD) telephone survey that provides standardized health-related data for California's population, is modeled after the National Health Interview Survey (NHIS). In 2000, NCI together with Centers for Disease Control (CDC) sponsored a CCM to be part of the 2000 NHIS (OMB No. 0920-0214, Federal Register, August 24, 2000, Vol. 65, No. 165, p. 51621). These agencies also sponsored a similar CCM in the CHIS.

The mission of NCI is described in the Public Health Service Act. Title 42 USC 285a states:

The National Cancer Program shall consist of (1) an expanded, intensified, and coordinated cancer research program encompassing the research programs conducted and supported by the Institute and the related research programs of the other national research institutes, including an expanded and intensified research program for the prevention of cancer caused by occupational or environmental exposure to carcinogens, and (2) the other programs and activities of the Institute.

Title 42 USC 285a-1 further directs that:

The Director of the Institute shall establish and support demonstration, education, and other programs for the detection, diagnosis, prevention, and treatment of cancer and for rehabilitation and counseling respecting cancer.

Attachment 1 contains the full text of the authorizing legislation, Title 42 USC 285. 

The DCPPS conducts and supports an integrated program of genetic, epidemiological, behavioral, social, and surveillance research in support of NCI's mission. The ARP plans, conducts, and supports research and development activities designed to monitor progress against cancer, including researchthat: (1) evaluates patterns and trends in cancer-associated risk factors, health behaviors, practices, outcomes, and services; and (2) investigates the influence of individual, societal, and system level factors on patterns, trends, and burden associated with cancer, including incidence, morbidity, mortality, and survival. To achieve its research objectives, the ARP targets: (1) identification, improvement, and development of databases and systems for research on cancer surveillance and outcomes; (2) maintenance and dissemination of these data and methods; and (3) promotion and facilitation of use of these systems by investigators in the extramural research community and federal agencies.

The CHIS 2007 CCM has been specifically designed to fulfill ARP's research objectives. CHIS will collect data on health- and disease-related topics such as patterns and trends in cancer screening, disease risk factors, disease outcomes, family history of disease, and social factors such as discrimination.  

 The large CHIS sample size, combined with the diversity of California's population, permits NCI and other federal agencies to obtain estimates for ethnic subgroups in the population for which NHIS has insufficient numbers for robust analysis. CHIS can provide detailed data on the following subpopulations of interest not currently available in national surveys: Asian subpopulations (Chinese, Filipino, Korean, and Vietnamese), Native Hawaiians and Other Pacific Islanders, American Indian and Alaska Natives, and Latino/Hispanic subgroups such as Mexican, and Mexican-American. CHIS data have been used in national reports to provide information on health disparities among Asian and Hispanic populations.

The NCI also has been advised to improve its capacity to perform cancer-related ecologic analysis using geographic information systems (GIS) and other spatial sampling and analytic methods. The CHIS data files include latitude and longitude variables, which can be linked with other data sources to perform geographic analyses.

Furthermore, the CHIS provides an opportunity for the NCI to collaborate with the CDC, CDHS, UCLA CHPR, PHI, and several major national and California foundations to enhance a health-related surveillance system for use in planning comprehensive cancer prevention and control efforts. Funding by the State of California supports the use of CHIS data by state and local health departments, community-based organizations, and health care providers in conducting cancer surveillance, needs assessment, planning, and targeting and evaluating intervention efforts at the local level and in underserved and minority populations.

A.2. Purposes and Uses of the Data

NCI's primary objectives for supporting the CHIS 2007 CCM are to:

         Collect and analyze data on racial/ethnic populations that have insufficient numbers for analysis in the NHIS;

         Increase NCI's capability to conduct ecologic analysis at the county level (or sub-county level in the case of heavily populated areas);

         Collect data for evidence-based programs and policy;

         Use modeling techniques to compare NHIS estimates for small population subgroups with CHIS data for the same groups; and

         Provide data that can be used in hierarchical analyses for small populations at risk of health disparities.

The data collected in CHIS 2007 will fill gaps in existing data collection systems. Like the NHIS survey (OMB No. 0920-0214), the CHIS 2007 CCM will assist NCI in tracking progress for Healthy People 2010. NCI is using the CHIS 2001, CHIS 2003, and CHIS 2005 data to: (1) better estimate health-related behaviors and cancer risk factors for smaller racial/ethnic populations, (2) track emerging trends in cancer prevention and control in small areas, and (3) identify and understand factors related to cancer prevention and control in small areas. Such information might ultimately have significance for broader national studies. Attachment 2 contains the specific questions in the CHIS 2007 CCM and the Demographic Core.

As was done in 2003, the CDC is using the NCI contract to sponsor questions on: (1) epilepsy and seizure disorders, and (2) family history of coronary heart disease, stroke, and diabetes in the CHIS 2007 adult questionnaire (see Attachment 2). The 2005 epilepsy questions will provide the first estimates of trends of epilepsy in a diverse population. The family history module will provide a population-based data to calculate prevalence and explore individual and family-level contributors to coronary heart disease, stroke, and diabetes. Given the large and diverse CHIS sample, the inclusion of epilepsy and family history questions will allow not only a precise general population estimate, but also sufficient sample to produce estimates for a number of subgroups—geographic and racial/ethnic. As in previous cycles of CHIS, the questions are included in the CCM module and the burden estimate.

CHIS data are broadly disseminated via Public Use Files (PUFs), an online data query system called AskCHIS, and reports and publications. These data are widely used by federal and California state government agencies, researchers, policymakers, and communities. California local health departments, community-based organizations, and health care providers use these data for surveillance, needs assessment, intervention, and program planning for disease prevention and control. More than 500 researchers have downloaded PUFs, and 20,000 users have accessed CHIS data through AskCHIS. NCI research studies, as well as more than 150 other projects, are listed in the CHIS Research Clearinghouse at the UCLA CHPR web site for CHIS. The Clearinghouse also lists approximately 50 peer-reviewed publications based on CHIS data. Moreover, the Agency for Health Research and Quality reported CHIS data in its annual Healthcare Disparities Report (http://www.arhq.gov/qual/nhdr02/nhdrprelim.htm). Attachment 7I describes in more detail how CHIS data have made an impact and lists key users of CHIS data.

A.3. Use of Information Technology To Reduce Burden

 

 The survey contractor will use Computer Assisted Telephone Interviewing (CATI) technology in the implementation of this telephone survey.

 

A.4. Efforts To Identify Duplication

Three previous cycles of CHIS have been approved by the Office of Management and Budget (OMB): 2000 CHIS CCM, OMB No. 0925-0478, Exp. 6/30/2003; CHIS CCM, OMB No. 0925-0518, Exp. 5/31/2004; 2005 CHIS CCM, OMB No. 0925-0000, Exp. 5/13/2006. There is no similar information that is readily available. Prior to providing support for CHIS, NCI evaluated the other two CDC-sponsored surveys that provide publicly-available population-based health data in California--the Behavioral Risk Factor Surveillance System, the State and Local Area Integrated Telephone Survey [(SLAITS), OMB No. 0920-0406, Federal Register, June 1, 2000, Vol. 65, No. 106, pp. 35094-35095].  However, neither survey had adequate sample size for local-level analysis or ecological analysis. Neither collected latitude or longitude variables that can be linked with other data sources to perform geographic analysis. Neither instrument collected the range of covariates needed to analyze cancer control outcomes that would meet the objectives of NCI.

A.5. Small Business

No small businesses will be involved with this study.

A.6. Consequences of Not Collecting the Information

This request for clearance is for CHIS 2007 only. The periodic data collection throughout the state will take 6 - 9 months. For subsequent biennial CHIS surveys, individual clearance requests will be submitted to the OMB.

The CHIS is conducted biennially. Collecting the data biennially reduces the burden on the California population while providing robust estimates of the health and health care utilization of the California population at reasonable cost. This is the minimum frequency of data collection consistent with the objectives and study design. Accurate and current information at these time points are necessary to track progress in meeting Healthy People 2010 objectives and to analyze emerging trends in cancer prevalence and control.

A.7. Special Circumstances Justifying Inconsistencies with Guidelines in 5 CFR 1320.6

There are no special circumstances.

A.8. Consultation Outside the Agency

Outside agencies are consulted extensively on the CHIS design and implementation. More than 150 persons serve on formal advisory bodies: the CHIS Advisory Board (AB), CHIS Advisory Committees, and CHIS Working Groups. These groups are comprised of experts from federal and state government, academic, and health organizations.

Attachments 7A-E contains rosters for the CHIS AB and the CHIS Adult Technical Advisory Committee (TAC), Multicultural TAC, Sampling and Methodology TAC, and Data Disclosure Advisory Committee (DDAC). 

The CHIS AB provides ongoing advice on policy and procedures related to survey content, sampling strategy, and dissemination. It provided recommendations on CHIS 2007 at its April 18 and November 14, 2006 meetings. The Multicultural TAC advises CHIS staff on content and survey methodology issues related to the state's ethnic and racial groups. It met on March 7, 2006 and advised on which populations require in-language questionnaires due to linguistic isolation and the cultural appropriateness of the instrument for the various languages and cultures. The Adult TAC met on Feb. 10, 2006 and provided expert input on questionnaire content, measurement issues, and policy relevance for adults age 18 and over. The Adolescent TAC met on February 28, 2006 to address questionnaire content for adolescents age 12 – 17.  The Sampling Design and Survey Methodology TAC consults on sampling options, weighting issues, response rate strategies, and survey implementation protocols. The DDAC advises CHIS on confidentiality and data release policies for CHIS data dissemination. In addition, Working Groups advise on specific content areas of the survey, including diet, nutrition, and physical activity; women's health; and acculturation, access, and discrimination.

A.9. Payments or Gifts to Respondents

The CHIS 2007 plans to include a pre-paid financial incentive of $2.00 (a two-dollar bill) for the Random Digit Dial (RDD) sample with the advance letter sent to all households that have an available address (see Attachment 4). For respondents for whom no address is available, the $2.00 financial incentive will be offered to the selected adult respondent upon initial telephone contact. The amount of these small payments and the methods for distributing them to potential respondents are consistent with the practices of comparable national telephone surveys with federal sponsorship. The use of small financial incentives has been shown to significantly increase response rates for telephone surveys[1] and their use in CHIS 2005 increased the CHIS response rate by about three percent. Cell phone respondents are paid $5 for completion of the screener and $25 for completion of the extended interview to cover their costs for use of cell phone minutes.

[1] Singer, E., Van Hoewyk, J. and M.P. Maher. 2000. “Experiments with Incentives on Telephone Surveys.” Public Opinion Quarterly, 64: 171-188.

A.10. Assurance of Confidentiality

The information to be collected by CHIS constitutes a system of records under the Privacy Act, System No. 09-25-0200 (see Attachment 7J). The Federal Register Notice for this system of records (Federal Register, April 7, 1997, Vol. 62, No. 66, pp. 16596-16602) is incorporated in NCI’s contract with UCLA CHPR to conduct CHIS, N02-PC--54400. The CHIS data are designated as limited rights data under this same contract.

All CHIS 2007 respondents will be assured of the voluntary nature of the survey, both in writing, via the Advance Letter, and verbally, at the time of telephone contact (Attachment 4). They will also be assured that their responses will be kept confidential and used only for purposes of the survey. The statutory authority is cited in the Advance Letter (see Attachment 4). 

The CHIS 2007 CCM complies with 45 CFR46 (Protection of Human Subjects). Attachment 6 contains documentation of review and approval by UCLA’s Office for the Protection of Human Subjects (FWA No. 00004642). CHIS 2007 has also applied for a Certificate of Confidentiality from the National Institutes of Health to protect these research data from forced disclosure.

The following confidentiality and security measures will be taken to protect respondent confidentiality. Once data are collected, the CHIS 2007 data collection subcontractor will separate the contact data (first name, address, telephone numbers, and birth date) from the analytical data and store it in separate ID files. Contact data will be destroyed upon completion of the study. Only the analysis files will be delivered to the UCLA CHPR. 

No identifying information will be included in any publicly released data file, report, publication, or presentation. Direct identifiers and highly sensitive information that might result in legal jeopardy to respondents are redacted from the analysis files prior to delivery to CHIS 2007 funders with contractual rights to the data. CHIS results are disseminated by UCLA CHPR through: (1) an on-line data query system called AskCHIS, which provides population estimates and uses suppression criteria that prevent the release of identifying information, (2) electronic public use microdata files in which data disclosure limitation techniques have been carefully implemented to protect respondent confidentiality, and (3) a Data Access Center where researchers can access microdata in a secure and supervised environment.

A.11. Questions of a Sensitive Nature

The federal Department of Health and Human Services (DHHS) defines sensitive information as information about:  (1) a subject's psychological well-being or mental health, (2) illegal conduct/behaviors, (3) sexual attitudes, preferences, or behaviors, (4) alcohol or illegal drug use, or (5) genetic information. The CHIS 2007 CCM collects data on cancer screening, cancer diagnosis, common medications, sun exposure, discrimination, epilepsy, and family history of heart disease, stroke, and diabetes. None of these data constitute sensitive data as defined by DHHS.

A.12 Estimates of Response Burden

 Table A.12.1 provides estimates of the annual hour burden for the CHIS 2007 CCM and the federally funded portion of the demographic core. Less than 30 minutes will be required to administer the entire adult questionnaire for the CHIS 2007 survey; timed tests (n=9) indicate that the CHIS 2007 CCM and the federally sponsored portion of the Demographic Core can be administered to adults in an average of .12 hours to adolescents in an average of .0134 hours. Because not all questions apply to each person and the survey instrument automatically skips over questions that do not apply, no respondent is ever asked all of the questions. The hour burden is calculated by multiplying the number of respondents by the frequency of response by the average hour burden per response. Table A.12.2 breaks out the hour burden estimates by each form. Table A.12.3 reports the respondent costs associated with the CHIS 2007 CCM and the federally funded portion of the Demographic Core. The median wage rate for California is estimated at $17.00 per hour for adults. For adolescents, the California minimum wage of $7.50 per hour is used. 

A.12.1. Number of Respondents, Frequency of Response, and Annual Hour Burden

A.12.1 Estimates of Hour Burden
Type of Respondent	Number of Respondents	Frequency of Response	Average Time Per Response	Annual Hour Burden
Adults	48,150	1	.1200	5778.0
Adolescents	4,015	1	.0134	53.8
Total				5831.8

A.12.2. Hour Burden Estimates by Each Form and Aggregate Hour Burdens

A.12.2.Hour Burdens by Form and Total Hour Burdens
Form Type	Number of Respondents	Frequency of Response	Average Time Per Response	Annual Hour Burden
Adult Pilot	150	1	.1200	18.0
Adult Survey	48,000	1	.1200	5760.0
Adolescent Pilot	15	1	.0134	.2
Adolescent Survey	4,000	1	.0134	53.6
Total	52,165			5831.8

A.12.3. Estimates of Annualized Cost to Respondents for the Hour Burdens

 

A.12.3 Annualized Cost to Respondents
Respondent Type	Number of Respondents	Annual Hour Burden	Hourly Wage Rate	Respondent Cost
Adult	48,150	.1200	$17.00	$98,226.00
Adolescent	4,015	.0134	$7.50	$403.51
Total				$98,629.51

A.13. Estimate of Total Capital and Startup Costs/Operation and Maintenance Costs to Respondents or Record Keepers

There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

A.14. Estimates of Costs to the Federal Government

 The NCI staff time allocated to participating in CHIS 2007 planning and design activities, monitoring the study, and preparing analyses and publications is estimated at .50 FTE over the 2-year contract period. NCI costs associated with staffing CHIS equal $133,693 over two years, or $66,846.50 per year. The 2-year contractual cost to the federal government for the CHIS 2007 data collection is $2,660,300; the annualized contractual cost is $1,330,150. The total annualized federal cost (NCI staff plus contractual cost) equals $1,396,996.50.

A.15. Changes in Burden

     

The 2007 CHIS CCM is being submitted to OMB as a new collection of information. The burden for the 2007 CHIS CCM is comparable with that of the CHIS 2001 CCM, CHIS 2003 CCM, and CHIS 2005 CCM, each of which was approved by OMB as a separate, new information collection.

A.16. Plans for Publication, Analysis, and Schedule

The 2007 CCM will be conducted as part of the large, statewide CHIS, which is funded in part by California state agencies, county agencies, and private, non-profit foundations. The data collection will conform to the timeline for key activities summarized in Table A.16.

Table A.16    Project Timeline

Activity	Start Date
Pre-test	Completed
Pilot test CHIS for CATI administration	One month after OMB approval
Field CHIS questionnaire	Two months after OMB approval
Prepare preliminary frequency output file	15 months after OMB approval
Finalize CHIS data files (without identifiers)	20 months after OMB approval
Complete final CHIS report	24 months after OMB approval

 

The CHIS 2007 CCM data will be disseminated as widely as possible; results are routinely disseminated to both national and California audiences so that the data can be used by as large a number of stakeholders as possible. Results will be disseminated through reports and policy briefs, in-person presentations, and on the Internet. CHIS data will be made available to the public through public use data files (disseminated via the Internet) and an online query system called AskCHIS, where county-level data estimates may be obtained. Researchers can access confidential microdata through the secure Data Access Center at the UCLA CHPR.  

A.17. Approval to Not Display Expiration Date

All questionnaires will display the OMB number, expiration date, and burden statement.

A.18 Exceptions to Item 19 of OMB Form 83-I

No exceptions to Certification for Paperwork Reduction Act Submissions are requested.