OMB disapproves this study of barriers to participant compliance in a flexible sigmoidoscopy screening program. CDC has failed to demonstrate that the study has practical utility, as required by 5 CFR 1320.5(d)(1)(iii) of the rules implementing the Paperwork Reduction Act. First, CDC's sample selection is flawed, excluding all HMO members that have had a sigmoidoscopy in the last ten years or have a history of specifically identified medical conditions. By failing to include these groups in the study, CDC has no means to determine whether the knowledge and attitudes of members not having had a sigmoidoscopy (included) differ from those members having had a sigmoidoscopy (excluded). Similarly, CDC would only interview partipants with negative examinations, and thus will not be able to whether their attitudes differ from participants with positive examinations. Second, CDC's anticipated 60 precent response rate is too low, exacerbating inherent weaknesses in the representativeness of the sample. At best, CDC's proposed study population is only representative of California HMO members. At worst, the population is only representative of the members in the contractor's HMO. In either case, the proposed study population does not necessarily represent individuals in non-HMO health insurance alternatives (e.g., fee-for-service) in California or across the U.S. In addition, the 519 HMO member pilot study, which only received a 56.4 percent response rate, was not approved by OMB and, therefore, a violation of the Paperwork Reduction Act. Third, the principal beneficiary of the study's findings appears to be the contractor and not the Federal government. OMB bases this concern on several elements in the study, including the contractor's focus on adding promotional materials (that clearly benefit the contractor) as a result of the pilot study instead of addressing the low response rate. Furthermore, the invitation letter and questionnaire are also promotional for the primary benefit of the contractor. Fourth, the survey instrument includes a large number of questions that are duplicative, unnecessary, or unlikely to elicit an objective response. CDC may resubmit the survey request, along with revisions to resolve the concerns outlined above, consistent with the requirements of 5 CFR 1320.10.
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The proposed study will examine determinants of compliance with an ongoing screening flexible sigmoidoscopy program among the members of an HMO. Of particular interest are differences in knowledge, attitudes, and screening behavior; the role of anxiety over discomfort or embarrassment; and the role of practical barriers.
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Examination of Barriers to Participant Compliance in a Flexible Sigmoidoscopy Screening Program