Colorectal Cancer Control Program Indirect/Non-Medical Cost Study
OMB Supporting Statement
Part B: Collection of Information Employing Statistical Methods
Contact:
Florence Tangka, PhD
Division of Cancer Prevention and Control
National Center for Chronic Disease Prevention and Health Promotion
Centers for Disease Control and Prevention
Atlanta, Georgia
Telephone: 770-488-1183
Electronic Mail: [email protected]
March 1, 2013
TABLE OF CONTENTS
Section Page
B. Collection of Information Employing Statistical Methods 1
B.1 Respondent Universe and Sampling Methods 1
B.2 Procedures for the Collection of Information 1
B.3 Methods to Maximize Response Rates and Deal with Nonresponse 2
B.4 Test of Procedures or Methods to be Undertaken 2
B.5 Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data 2
LIST OF ATTACHMENTS
A Authorizing Legislation
B 60-day Federal Register Notice
C Colonoscopy questionnaire
D Colonoscopy questionnaire protocol instructions
E FIT questionnaire
F FIT questionnaire protocol instructions
G Colonoscopy Web-based Questionnaire Screens (English and Spanish)
H FIT Web-based Questionnaire Screens (English and Spanish)
I Summary of Analysis Plan
The respondents are patients screened for colorectal cancer (CRC) by a provider contracted by participating CRCCP programs. CDC has reached out to several programs to assess willingness and ability to partner for this study. Programs in five states have agreed to collaborate with CDC: Alabama, Arizona, Colorado, New York, and Pennsylvania. The geographic diversity will ensure variation in respondent characteristics. Providers associated with each program serve patients in tribal organizations, patients with a variety of primary languages, and patients of various ethnicities. CDC expects that the variation in respondent characteristics will yield meaningful results from the targeted sample size.
Convenience sampling will be employed. At the participating sites each patient screened will be asked to participate until a total of 75 to 150 questionnaires have been completed. This approach ensures that the entire population of patients screened at each site (in the timeframe required to reach the target number of completed questionnaires) has the opportunity to participate in the study, which reduces any impact from non-random sampling.
Because the program (and at a more specific level, each site) targets a particular population for screening provision, it is reasonable to assume that the sample used for this study is representative of the population served by the screening program. The sample surveyed will be representative of the population that have the lowest rates of screening compliance, and for whom indirect and non-medical costs are likely to be a substantial barrier to screening.
Additional information about the analysis plan is provided in Attachment I.
The programs will be responsible for collecting completed paper surveys from participants as well as for recording completion of online surveys. In addition the programs will distribute the incentive (gift card) to participants who complete the survey. Each program will maintain a record of participants and their assigned (de-identified) number. The completed questionnaires will only contain the de-identified number and not any personal information. RTI will receive the completed paper questionnaires and the online survey data. RTI and CDC will not have access to personal information that could identify participants.
The programs and their contracted providers will be responsible for collecting completed surveys from and distributing the incentive (gift card) to participants who complete the survey. Programs will store all of the completed questionnaires until the target number of surveys has been completed for that site. Each site will maintain a record of participants and their assigned (de-identified) number. The patient identifier will be formatted as: XX-YY-ZZZZZ, where XX is the two-character state abbreviation, YY is a two-digit code to identify the site where the survey was completed (as some programs will collect data through providers at multiple sites, each program will assign a site code to each provider site), ZZZZZ is the five-digit number used to identify the patient, the survey format, and the assistance of a patient navigator (the first three digits are assigned to the patient screened (using consecutive numbers based on the order of survey completion), the fourth digit is a code used to distinguish the format of the questionnaire (surveys with be completed on paper (P) or online (W) and the fifth digit denotes whether the patient completed the survey with (N) or without (S) assistance from a patient navigator). The completed questionnaires will only contain the de-identified number (XX-YY-ZZZZZ) and not any personal information. The economic evaluation contractor, RTI, will receive the completed questionnaires and will not have access to personal information that could identify participants.
Each grantee has made arrangements to make patient navigators (who work with the patient throughout the screening process) available to assist participants as needed. Patient navigators will be available to walk participants through the survey and record answers to questions, or to answer questions about the survey as needed.
Professional training in the administration of the survey will be available to all patient navigators prior to beginning the study. Programs and their contractors will also receive Colonoscopy Questionnaire Protocol Instructions or the FIT Questionnaire Protocol Instructions, which provide complete written instruction regarding administering the survey. Small incentives in the form of gift cards will be made available to participants who complete the survey.
Each questionnaire (colonoscopy and FIT) was pilot tested with patients screened by participating providers to test for survey quality and usability and as a tool to estimate time burden associated with completing the questionnaire. Feedback from pilot testing was incorporated into the final version questionnaires. The estimates of time burden presented in Part A of the Supporting Statement were generated from pilot testing results.
Florence Tangka, Ph.D., of the Division of Cancer Prevention and Control, is the Principal Investigator and Technical Monitor for the study, and has overall responsibility for overseeing the design, conduct, and analysis of the study. She will approve and receive all contract deliverables. Telephone: 770-488-1183.
The survey instrument, sampling and data collection procedures, and analysis plan were designed in collaboration with researchers at Research Triangle Institute (RTI) International. RTI will conduct data collection and will perform data analysis, in consultation with the CDC investigators.
Sujha Subramanian, Ph.D. [781-434-1749] has overall technical and financial responsibility for the study at RTI and led the RTI effort to design this protocol. Dr. Subramanian will direct the overall data collection and analysis effort.
Other personnel involved in design of the protocol and data collection instruments are:
Maggie Cole Beebe, Ph.D. RTI International Research Economist [survey instrument design, data analysis] 781-434-1728
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Gerald F. Riley, Ph.D. Division of Research on Health Plans & Drugs, CMMI/CMS Sr. Researcher [survey instrument design, data analysis and interpretation] |
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Cai SR, Zhang SZ, Zhu HH, Zheng S. Barriers to colorectal screening: A case control study. World J Gastroenerol. 2009;15(20):2531-2536.
Centers for Disease Control and Prevention. Vital Signs: Colorectal Cancer Screening Among Adults Aged 50-75 Years—United States, 2008. Morbidity and Mortality Weekly Report. 2010;59:1-5.
Heitman SJ, Au F, Manns BJ, et al. Nonmedical costs of colorectal cancer screening with the fecal occult blood test and colonoscopy. Clin Gastroenterol Hepatol. 2008; 6(8): 912-917.
James AS, Hall S, Greiner KA, et al. The impact of socioeconomic status on perceived barriers to colorectal cancer testing. Am J Health Promot. 2008;23(2):97-100.
Jonas D E, Russell LB, Sandler RS, et al. Patient time requirements for screening colonoscopy. Am J Gastroenterol. 2007;102(11): 2401-2410.
Joseph DA, DeGroff AS, Hayes NS, et al. The Colorectal Cancer Control Program: partnering to increase population screening. Gastrointest Endosc. 2011; 73(3):429-34.
Mandel JS, Church TR, Ederer F, Bond JH. Colorectal Cancer Mortality: Effectiveness of biennial screening for fecal occult blood. J Natl Cancer Inst. 1999;91(5):434-437.
Mandel JS, Church TR, Bond JH, et al. The effect of fecal occult-blood screening on the incidence of colorectal cancer. N Eng J Med. 2000;343:1603-1607.
Natale-Pereira A, Marks J, Vega M, et al. Barriers and facilitators for colorectal cancer screening practices in the Latino community: perspectives from community leaders. Cancer Control. 2008;15(2): 157-165.
O’Malley AS, Beaton BA, Yabroff KR, et al. Patient and provider barriers to colorectal cancer screening in the primary care safety-net. Preventive Medicine. 2004;39:56-63.
Pignone MP, Flitcroft KL, Howard K, et al. Costs and cost-effectiveness of full implementation of a biennial faecal occult blood test screening program for bowel cancer in Australia. Med J Aust. 2011;194(4):180-185.
Seeff LC, Nadel MR, Klabunde CN, et al. Patterns and predictors of colorectal cancer test use in the adult US population. Cancer. 2004;100:2093–2103.
Stock C, Knudsen AB, Lansdorp-Vogelaar I, et al. Colorectal cancer mortality prevented by use and attributable to nonuse of colonoscopy. Gastrointest Endosc. 2011;73(3):435-443 e5.
Subramanian S, Amonkar MM, Hunt TL. Use of colonoscopy for colorectal cancer screening: evidence from the 2000 National Health Interview Survey. Cancer Epidemiol Biomarkers Prev. 2005;14:409–416.
U.S. Cancer Statistics Working Group. United States Cancer Statistics: 1999–2007 Incidence and Mortality Web-based Report. Atlanta: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention and National Cancer Institute; 2010. Available at: www.cdc.gov/uscs.
Von Wagner C, Baio G, Raine R, et al. Inequalities in participation in an organized national colorectal cancer screening programme: results from the first 2.6 million invitations in England. Int J Epidemiol.2011; Feb 17 (epub ahead of print).
Whitaker KL, Good A, Miles A, et al. Socioeconomic inequalities in colorectal cancer screening uptake: Does time perspective play a role? Health Psychol. 2011;May 30 (epub ahead of print).
Yang H, Ge Z, Dai J, Li X, Gao Y. Effectiveness of the immunofecal occult blood test for colorectal cancer screening in a large population. Dig Dis Sci. 2011;56(1):203-207.
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| Author | Maggie Cole Beebe |
| File Modified | 0000-00-00 |
| File Created | 2021-01-30 |