Assessing Problem Areas in Referrals for Chronic Hematologic Malignancies and
Developing Interventions to Address Them
Supporting Statement
Part A
August 27, 2009
Revised December 9, 2009
Contact:
Katherine M. Wilson, PhD, MPH, CHES
Telephone: (770) 488-3079
Fax: (770) 488-4639
Email: kxw1@cdc.gov
Division of Cancer Prevention and Control
National Center for Chronic Disease Prevention and Health Promotion
Centers for Disease Control and Prevention
4770 Buford Highway, NE, MS K-55
Atlanta, Georgia 30341
Part A. Justification
1. Circumstances Making the Collection of Information Necessary
2. Purpose and Use of the Information Collection
3. Use of Information Technology and Burden Reduction
4. Efforts to Identify Duplication and Use of Similar Information
5. Impact on Small Businesses or Other Small Entities
6. Consequences of Collecting the Information Less Frequently
7. Special Circumstances Relating to Guidelines of 5 CFR 1320.5
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency
9. Explanation of Any Payment or Gift to Respondents
10. Assurance of Confidentiality Provided to Respondents
11. Justification for Sensitive Questions
12. Estimates of Annualized Burden Hours and Costs
13. Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers
14. Annualized Cost to the Federal Government
15. Explanation for Program Changes or Adjustments
16. Plans for Tabulation and Publication and Project Time Schedule
17. Reason(s) Display of OMB Expiration Date is Inappropriate
18. Exceptions to Certification for Paperwork Reduction Act Submissions
References
List of Attachments
Attachment 1 Section 301 of the Public Health Service Act [42 USC 241]
Attachment 2a 60 Day Federal Register Notice
Attachment 2b Summary of Public Comments
Attachment 3 Community Oncologists and Hematologists Interview Phone Recruitment
Script
Attachment 4 Community Oncologists and Hematologists Interview Guide
Attachment 4A Informed Consent for Physicians (includes Oncologists and Hematologists)
Attachment 5 Patient Interview Phone Recruitment Script
Attachment 6 Patient Interview Guide
Attachment 6A Consent for Patient Interview
Attachment 7 PCP Survey Cover Letter including consent information
Attachment 8 PCP Survey
Attachment 9 PCP Survey Opt-Out Card
Attachment 10 PCP Survey Reminder Letter
Attachment 11 PCP Interview Phone Recruitment Script
Attachment 12 PCP Interview Guide
Attachment 4A Informed Consent for Physicians (includes PCPs)
Attachment 13 PCP Focus Group Phone Recruitment Script
Attachment 14 PCP Focus Group Guide
Attachment 14A PCP Focus Group Consent
Attachment 15 IRB Approval Letters
Dana Farber Cancer Institute
MD Anderson Cancer Center
University of Texas Houston
Attachment 16 Short Descriptions of other CDC- funded Hematology Projects
Attachment 17 Overall Study Plan with Publications
A1. Circumstances Making the Collection of Information Necessary
The Centers for Disease Control and Prevention (CDC) requests approval by the Office of Management and Budget (OMB) for a new, one-year data collection request to conduct a formative research project that will inform the development of an intervention prototype for increasing referrals from primary health care providers to hematologic specialists. Qualitative and quantitative information will be collected using three different methods: in-depth interviews, focus groups and survey. The data collection for which approval is sought is in accordance with CDC's mission to conduct, support, and promote efforts to prevent cancer and to increase early detection of cancer, authorized by Section 301 of the Public Health Service Act [42 USC 241] (Attachment 1). The proposed project is central to the prevention research agenda of the Division of Cancer Prevention and Control, CDC.
The quality and timeliness of health care in the United States is critical to the health of the population. Numerous efforts to assess and improve the quality of health care are supported through the Insitute of Medicine (IOM) Health Care Quality Initiative (http://www.iom.edu/CMS/8089.aspx). One of the reports produced through the initiative, Crossing the Chasm,1 described significant delays in all aspects of care delivery, including access to appointment, waits in offices and facilities, prolonged response to diagnostic findings and overdue implementation of therapeutic interventions. The IOM panel concluded that delays in diagnosis can result in emotional distress, physical harm, and lack of respect to patients, and thus identified improving timeliness of patient care as one of six aims. A separate report produced through the IOM initiative, To Err is Human, identified mistakes and delay in diagnosis as a key diagnostic error for quality improvement efforts.2
Research conducted in the United Kingdom provides additional insight into the issues. Analysis of National Health Service Data3 revealed that delays in diagnosis and specialty referral are common and that patients who saw primary care providers were more likely to experience delays.4 Several other patient characteristics were implicated in excess delay, including age, socioeconomic status, race/ethnicity, and marital status.5 Additional data from Europe and Canada, as well as single-site studies in the United States, specifically allude to a problem of timely referral and diagnosis for patients with cancer.
Despite the advent of new diagnostics and therapeutics for patients with chronic hematological malignancies, the size and scope of a potential problem regarding their referral from primary care providers to specialists is not well-defined in the current literature.6 The most salient papers come from the United Kingdom, where studies of lymphoma7 and myeloma8 patients identified female gender and heavier symptom burden as additional contributors to delay. For lymphoma alone, the calculation of delays ranges dramatically, from 103 days (UK, lymphoma)3 to 240 days (UK, lymphoma chart review),9 to 137 days (Canada, lymphoma).7 To our knowledge, however, no study has specifically assessed primary care physicians’ attitudes and practices regarding the screening and diagnosis of hematological malignancies in the United States.6 The complex, time-sensitive nature of the health care system makes delays in any aspect of the care process problematic and difficult to remedy.
To address this gap in knowledge, the Centers for Disease Control and Prevention (CDC) requests OMB approval to conduct research that will elucidate current practice patterns for the referral of patients with chronic hematological malignancies. The principal information collection will engage primary care physicians (PCPs) since they are most often the first point of contact in the medical system for cancer patients, and as such, serve a critical role in facilitating cancer diagnosis and treatment. The PCP has long been expected to expedite the referral of patients with suspected malignancy to hematologists or oncologists. While clear guidelines exist for screening and detecting the more common malignancies such as breast, colon, and cervical cancer, the hematologic malignancies pose a special problem for the primary care physician because they often present with subtle signs and symptoms. This is especially true of the chronic hematologic malignancies such as chronic lymphocyte leukemia (CLL), (CML), myelodysplastic syndrome (MDS), multiple myeloma (MM) and certain indolent types of non-Hodgkin’s lymphoma (NHL). Moreover, until the last decade, patients had few treatment options and primary care providers may not have felt that referrals to specialists would impact the long term outcome of the patient. Information will also be collected from patients and from community hematologists and oncologists.
The specific aims of the project are to (1) document the specific problem(s) with respect to early recognition of chronic hematologic malignancies and referral pathways of these cases; (2) identify factors that contribute to the problem(s); (3) using an intervention mapping approach,10 develop a prototype of an intervention based on findings from Aims 1 and 2 to address the identified problem(s) and factors for full development at a later time; and (4) develop a protocol to evaluate the intervention in an efficacy trial.
Privacy Impact Assessment
As required for privacy impact assessment, the following items are described below: 1) an overview of the data collection system, 2) a delineation of the items of information to be collected and 3) an indication of whether the system hosts a website.
Overview of the Data Collection System
Three different collection methods will be used to collect data. In-depth interviews and focus groups will be conducted by University of Texas Houston (UTH) and MD Anderson Cancer Center (MDACC) in Texas. Dana Farber Cancer Institute (DCFI) will conduct the PCP survey in Massachusetts. The information collection from PCPs will involve a postal survey, in-person or telephone interviews and in-person focus group discussions. The information collection from oncologists and hematologists will involve in-depth interviews conducted by telephone. The information collection from patients will consist of in-depth interviews. Data will be kept for one year after publication.
Items of Information to be Collected
We propose administering a one-time postal survey to primary care providers (physicians) in Massachusetts with the purpose of understanding their knowledge of and ability to recognize hematologic conditions, and their patterns of referral for patients with suspected chronic hematological malignancies to hematologists, oncologists and other specialists. In addition, we propose conducting in-depth interviews with hematologists and hematologic cancer patients in Texas to identify the factors related to delays in referrals. Lastly, we propose focus groups of primary care providers in Texas to better understand their perceptions of factors that facilitate or inhibit timely referrals. Name and address from existing lists will be used only to recurit participants. REspnses data are de-identified (see Section A.10 for further description of process for de-identifying data). The exploratory nature of this proposed work fits the budget and strengths of each site.Together, these qualitative and quantitative data will be used to develop an intervention protoype which aims to reduce the time between diagnosis and referral of hematologic malignancies. The intervention prototype will be piloted at a later time.
Identification of Website(s) and Website Content Directed at Children Under 13 Years of Age
The proposed data collection does not involve the collection of information from websites or website content directed at children less than 13 years of age.
A2. Purpose and Use of the Information Collection
This is a one-time data collection for formative research on general practitioners’ and hematologists’ attitudes and practices regarding referral of patients for chronic hematological diseases. Since no existing database contains this information, not collecting it would thwart the efforts to develop a behavioral intervention relevant to improving providers’ referral behaviors.
Findings of this study will be shared for inclusion in a curriculum being developed elsewhere which actively seeks to educate primary care physicians to improve the diagnosis and referral of hematologic cancer patients. Not sharing it will mean incurring cost twice to find the same information.
Privacy Impact Assessment Information
The purpose of the project is to gain insight into the patterns of referral of patients with chronic hematologic malignancies and to develop prototypes of interventions focusing on PCPs. The ultimate goal is to develop tools that will improve the awareness, diagnosis, and early referral of persons with chronic hematologic cancers by PCPs. Data collected in this formative phase will be interpreted as a collective to provide insights to how providers and patients become aware of need for referral to a hematologic specialist. Using the Intervention Mapping protocol with these insights,10 an intervention prototype will be developed for piloting and an efficacy trial in future phases. Overall, the aim is to improve the timeliness of care for chronic hematologic disease.
Pre-existing records will be used to establish eligibility. Potential respondents will be identified from these pre-existing records and queried as to their interest in participating in the study. PCPs and community oncologists who agree to participate will provide information about professional practices and referral patterns. Patients who participate will provide information about their experiences as patients. Information from all perspectives (PCP, oncologist, patient) is necessary to identify system-wide strengths, weaknesses, and communication issues. The information is necessary to design an intervention that is responsive to the needs of both patients and health care providers, and facilitates improved care and referral for patients.
Information in identifiable form will be collected. A coded identifier will be assigned to each respondent and all questionnaires and opt-out cards will be identified with the coded identifier. The IIF will be collected by a contractor and maintained in linkable format for two years. After publications, the linkage information will be destroyed. We do not intend to share linkage information. It is maintained for quality assurance purposes only. The proposed data collection will have little or no impact on the respondent’s privacy.
3. Use of Improved Information Technology and Burden Reduction
Interviews and focus groups by their nature are not amenable to electronic information collection techniques, and therefore, have no electronic data collection mechanisms. To further reduce response time, the provider survey provides an option for completion via a web-based survey tool as well as the traditional paper survey. The web-based option is estimated to be used 50% of the time. No other data collection components of the project involve the use of automated, electronic or mechanical collection methods.
4. Efforts to Identify Duplication and Use of Similar Information
Despite the advent of new diagnostics and therapeutics for patients with chronic hematological malignancies, the size and scope of a potential problem regarding their referral from primary care providers to specialists is not well-defined in the current literature. To our knowledge, no study has specifically assessed primary care physicians’ attitudes and practices regarding the screening and diagnosis of hematological malignancies in the United States.6
The CDC has established an integrated initiative focusing on hematologic cancers. Twelve projects are funded to raise awareness about hematologic cancers (leukemia, lymphoma, and myeloma), including symptoms and treatments, to improve survivors' quality of life. See Attachment 16 for a brief synopsis of each of the initiative. Although these projects do share a focus on hematologic cancers, these aims of these projects do not overlap with our proposed work. As mentioned earlier, no similar data were found in our search of the literature.
5. Impact on Small Businesses or Other Small Entities
Physicians in private offices could possibly be respondents. Since the questions are to identify individual physician feelings and behaviors, it is not feasible to create a short form for doctors employed in small businesses. Every effort has been made to keep the survey and interviews focused on the key issues identified in the data collection instruments. We will not exceed the burden estimate for each component of the project.
6. Consequences of Collecting the Information Less Frequently
This is a one-time data collection for formative research on general practitioners’ and hematologists’ attitudes and practices regarding referral of patients for chronic hematological diseases. Since no existing database contains this information, not collecting it would thwart the efforts to develop a behavioral intervention relevant to improving providers’ referral behaviors. There are no legal obstacles to reduce the burden.
7. Special Circumstances Relating to the Guidelines of 5CFR 1320.5
All guidelines are met and the request fully complies with the regulation.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency
A. A 60-day Notice was published in the Federal Register on April 13, 2009, Vol. 74, No. 69, pp.16873-16874 (see Attachment 2a). The American Society of Hematology (ASH) requested and received additional information about the project, which included draft data collection instruments and an outline of study methodology. Based on the information provided, the American Society of Hematology submitted a letter of support with further recommendations concerning study design. This letter is included as Attachment 2b.
B. Efforts to consult outside the agency.
Since the aim of this project is to increase referrals by primary care physicians, it necessitates expertise both in hematology and in changing provider behavior. Hematologic experts at MD Anderson Cancer Center (MDACC) and the Dana Farber Cancer Institute (DFCI) were consulted for study design, survey sampling, and survey development several times during 2007 and 2008. Experts in developing interventions to change provider behavior at the University of Texas, Houston (UTH) were also consulted during the same time period for study design, survey content, and formative research activities, which would inform the process of intervention development and included the focus groups and interviews. Their names and contact information are listed below.
DANA FARBER CANCER INSTITUTE
Craig Earle |
617-632-5564 |
617-632-2270 |
|
44 Binney Street/Smith 271 Boston, MA 02115-6084 |
Gregory Abel |
617-632-2304 |
617-632-2270 |
|
|
Christopher Friese |
617-632-4939 |
617-344-0427 |
Christopher_Friese@dfci.harvard.edu
|
|
Lysa Magazu |
617-582-7935 |
617-632-2270 |
MD ANDERSON CANCER CENTER
Louis Foxhall |
713-792-2202 |
713-745-2646 |
|
Office of Physician Relations - Unit 220 1515 Holcombe Blvd Houston, TX 77030-4009 |
Carla Strom |
713-563-9517 |
713-745-2646 |
|
UNIVERSITY OF TEXAS HOUSTON
Maria Fernandez |
713-500-9626 |
713-500-9750 |
|
7000
Fannin, UCT Suite 2522 |
Pat Mullen |
713-500-9658 |
713-500-9750 |
|
|
Kay Bartholomew |
713-500-9630 |
713-500-9750 |
Leona.K.Bartholomew@uth.tmc.edu
|
We expect to share the findings with the project officer for the contract with the Institute of Continuing Medical Education (formerly Vox Medica) with the intention of including relevant findings in their curriculum for physician education.
9. Explanation of any Payment or Gift to Respondents
Primary care providers who participate in the survey will be offered an incentive of $100, PCPs in the interviews offered $50, and PCPs in the focus groups will be offered a light meal in advance to encourage participants to arrive on time. Hematologists participating in the interviews will receive $50. Patients participating in the interviews will be offered $30. The incentive for the survey was determined as part of the survey pilot test. The other incentives were based upon previous experiences in using these methods. Physicians are difficult to reach and there are many demands on their time. The incentives are needed to promote efficient recruitment of respondents into the study.
10. Assurance of Confidentiality Provided to Respondents
CDC’s collaborators will have access to information in identifiable form (IIF) to facilitate screening for study eligibility as well as recruitment and scheduling. The consent processes advise prospective respondents that only study staff will have access to the information being collected, and describe the privacy safeguards that will be implemented. Respondents will be informed that data will be treated in a confidential manner and will not be disclosed unless otherwise required by law. Safeguards such as the separation of IIF from response data are described in more detail below. CDC will receive a de-identified data set.
Letters of approval for the project from the Institutional Review Boards of Dana Farber Cancer Institute, MD Anderson Cancer Center and the University of Texas at Houston are included in Attachment 15.
A. Privacy Act Determination. This submission has been reviewed by ICRO, who has determined that the Privacy Act does apply. The applicable System of Records Notice (SORN) is 09-20-0136, Epidemiologic Studies and Surveillance of Disease Problems. After data has been collected, information is primarily retrieved by unique participant identifier codes, not by IIF. Access to the files that link IIF to coded identifiers is strictly limited. No IIF will be transmitted to CDC.
All respondents will be recruited from pre-existing record systems. The American Medical Association master file will be used to identify potential respondents for the PCP survey. The MDACC Involved Provider Database will be used to identify potential respondents for the interviews with PCPs and community oncologists/hematologists. The MDACC data warehouse will be used to identify potential respondents for the patient component of the study.
A minimum amount of demographic information will be collected for descriptive analysis of physician respondents.
Potential respondents for the patient component of the study will also be identified from a pre-existing record system at MDACC. The recruitment data file contacting IIF (contact information) will not contain information from the patient record. Information to be collected from patients during interviews will describe their personal experiences with diagnosis, referral, and treatment.
B. Safeguards. A coded identifier will be assigned to each respondent, and all questionnaires and opt-out cards will be identified with the coded identifier.
When the data are entered into the study response database, each record will be identified only by this coded identifier. A separate computer file that links the study identifier to the subject’s name will be maintained for one year past publication of findings. The cover letter for this study will describe the procedures used to safeguard privacy (Attachment 7).
For the focus groups, a set of appropriate codes will be developed for use in the qualitative analysis of the data. Qualitative analysis will be conducted using Atlas.ti.
For the interviews, MDACC staff will audio record, de-identify, and transcribe tapes of interviews, and provide them to UTH for analysis. No personal identifiers will be included in transcripts. Tapes and transcripts will be kept in a locked file, only accessible by the Principal Investigator and Project Director. Tapes will be destroyed after they are transcribed. A set of appropriate codes will be developed for use in the qualitative analysis of the data. Qualitative analysis will be conducted using Atlas.ti.
For the PCP survey, DFCI study staff will enter the responses submitted on paper into a password-protected Microsoft Access or MySQL database designed for this study. Participants choosing to respond electronically will submit responses via a secure web survey using the Illume Survey design and management system. Paper copies of questionnaires and other study materials will be kept in a locked file cabinet to which only the study staff will have access and destroyed one year after manuscript publication.
For the focus groups, MDACC staff will audio record, de-indentify and transcribe tapes of focus groups, and provide them to UTH for analysis. No personal identifiers will be included in transcripts, and only the research team will have access to the transcripts. Tapes and transcripts will be kept in a locked file, only accessible by the Principal Investigator and Project Director. Tapes will be destroyed after they are transcribed.
C. Consent. The procedures for obtaining consent have been approved by the appropriate IRBs. The appropriate consent-related information for PCPs is included in the survey cover letter (Attachment 7). PCPs who do not wish to participate in the PCP survey have the option of returning an opt-out card (see Attachment 9) to the study coordinator. For other study components, informed consent will be obtained at the time of the interview or focus group (see consent information in Attachments 4A, 6A, 12A, and 14A).
D. Voluntary Nature of Participation. Participation in the study is voluntary for all respondents (PCPs, community oncologists/hematologists, patients). The cover letter for PCPs (see Attachment 7) informs them that participation is voluntary. The voluntary nature of participation is also described in the informed consent process.
11. Justification for Sensitive Questions
Questions that may be deemed to be sensitive may be those that pertain to knowledge that is relevant to professional competence. These questions are essential for the identification of behaviors that may need to be altered to improve referrals. Race/ethnicity questions may also be considered sensitive by a portion of respondents; however, these questions are necessary for the interpretation of results of the information collection. All data will be de-identified and shared only in aggregate so that the behavior of individual PCPs or other providers is not singled out.
12. Estimates of Annualized Burden Hours and Costs
A. Estimates of the hour burden are presented below in Table 12A. They were derived from pilot tests of the instruments with nine or fewer individuals for each instrument. Scripts for asking if interested in the study were timed with other staff members. The community oncologists and hematologists interview phone recruitment script can be found in Attachment 3 and the interview guide in Attachment 4. The patient interview phone recruitment script can be found in Attachment 5 and the interview guide in Attachment 6. The PCP survey cover letter can be found in Attachment 7, the PCP survey in Attachment 8, the PCP Opt-Out card in Attachment 9, and the PCP reminder letter in Attachment 10. The PCP interview phone recruitment script can be found in Attachment 11 and the interview guide in Attachment 12. The PCP focus group phone recruitment script can be found in Attachment 13 and the focus group guide in Attachment 14. Data will be collected over a one-year period. A total of 198 burden hours is estimated.
A.12A Estimated Annualized Burden to Respondents |
|||||
Type of Respondents |
Form Name |
No. of Respondents |
No. of Responses per Respondent |
Average Burden per Response (in hours) |
Total Burden (in hours) |
Community Hematologists /Oncologists |
Community Hematologists and Oncologists Interview Phone Recruitment Script |
100 |
1 |
2/60 |
3 |
Community Hematologists and Oncologists Interview Guide
|
18 |
1 |
1.5 |
27 |
|
Patients |
Patient Interview Phone Recruitment Script
|
50 |
1 |
2/60 |
2 |
Patient Interview Guide |
18 |
1 |
1.5 |
27 |
|
Primary Care Providers |
Primary Care Provider Survey Cover Letter |
250 |
1 |
2/60 |
8 |
Primary Care Provider Survey
|
150 |
1 |
20/60 |
50 |
|
Primary Care Provider Opt-Out Card |
100 |
1 |
2/60 |
3 |
|
PCP Survey Reminder Letter |
200 |
1 |
2/60 |
7 |
|
Primary Care Provider Interview Phone Recruitment Script |
100 |
1 |
3/60 |
5 |
|
Primary Care Providers Interview Guide |
18 |
1 |
1.5 |
27 |
|
Primary Care Provider Focus Group Phone Recruitment Script |
50 |
1 |
3/60 |
3 |
|
Primary Care Providers Focus Group Guide |
18 |
1 |
2 |
36 |
|
Total |
198 |
||||
B. Annualized estimates of the costs to the respondents are presented below in Table A.12B. The source of wage-per-hour figures was the Department of Labor website (www.dol.gov). Specifically, the http://www.bls.gov/oes/current/oes_ma.htm website was accessed for Massachusetts provider wages and the website http://www.bls.gov/oes/current/oessrcst.htm was accessed for Texas provider and patient wage information. Both were accessed on August 12, 2008. The total estimated annualized cost to respondents is $13,827.
A.12B Estimated Annualized Cost to Respondents |
|||||||
Type of Respondents |
Form Name |
No. of Respondents |
No. of Responses per Respondent |
Average Burden per Response (in hours) |
Average Hourly Wage Rate |
Total Cost |
|
Community Hematologists /Oncologists |
Community Hematologists and Oncologists Interview Phone Recruitment Script |
100 |
1 |
2/60 |
$82.57 (TX) |
$275 |
|
Community Hematologists and Oncologists Interview Guide |
18 |
1 |
1.5 |
$82.57 (TX) |
$2,229 |
||
Patients |
Patient Interview Phone Recruitment Script |
50 |
1 |
2/60 |
$18.21 (TX) |
$30 |
|
Patient Interview Guide |
18 |
1 |
1.5 |
$18.21 (TX) |
$492 |
||
Primary Care Providers |
Primary Care Provider Survey Cover Letter |
250 |
1 |
2/60 |
$92.40 (MA) |
$770 |
|
Primary Care Provider Survey |
150 |
1 |
20/60 |
$92.40 (MA) |
$4,620 |
||
Primary Care Provider Opt-Out Card |
100 |
1 |
2/60 |
$92.40 (MA) |
$308 |
||
PCP Survey Reminder Letter |
200 |
1 |
2/60 |
$66.25 (TX) |
$442 |
||
Primary Care Provider Interview Phone Recruitment Script |
100 |
1 |
3/60 |
$66.25 (TX) |
$331 |
||
Primary Care Providers Interview Guide |
18 |
1 |
1.5 |
$66.25 (TX) |
$1,789 |
||
Primary Care Provider Focus Group Phone Recruitment Script |
50 |
1 |
3/60 |
$66.25 (TX) |
$166 |
||
Primary Care Providers Focus Group Guide |
18 |
1 |
2 |
$66.25 (TX) |
$2,385 |
||
|
Total |
$13,837 |
|||||
13. Estimate of Other Total Annual Cost Burden to Respondents or Record Keepers
There are no other record-keeping requirements associated with this information collection.
14. Annualized Cost to the Government
The annualized cost to the government of this one-year data collection is presented in Table A14 below. It includes the costs of the data collection contract and costs of CDC staff who oversee the project. Research Triangle Institute (RTI) of North Carolina is the primary contractor, and as such, receives the funds directly from the government. RTI distributes funds to the subcontractors (DFCI, MDACC, and UTH).
A. 14 Estimates of Annualized Cost to the Government |
|
Item |
Annualized Cost |
Lead Technical Monitor @ 2.5% FTE Oversees project and monitors scientific procedures and ethics of data collection. |
$2,500 |
Contractor - RTI Issues subcontracts for data collection; provides guidance on procedures and documentation to establish subcontracts; coordinates and participates in conference calls among contractor, CDC and subcontractors; and provides guidance subcontractors to develop work plans and budgets. |
$450,000
|
Total |
$452,500 |
15. Explanation for Program Changes or Adjustments
This is a new, one-time data collection.
16. Plans for Tabulation and Publication and Project Time Schedule
The overall project plan with publications indicated can be found in Attachment 17.
Project schedules for the survey, interviews, and focus groups are presented below in Tables A.16-1, A.16-2, and A.16-3, respectively.
A.16-1 Survey Time Schedule – Harvard/DCFI |
|
Activity |
Time Schedule |
Introductory letters and surveys sent by FedEx to potential respondents |
2 weeks after OMB approval |
Follow-up post card sent to non-responders |
4 weeks after OMB approval |
FedEx 2nd copy of cover letter and questionnaire to non-responders |
6 weeks after OMB approval |
Telephone non-respondents |
8 weeks after OMB approval |
Data entry and cleaning |
10-16 weeks after OMB approval |
Data analysis |
16–24 weeks after OMB approval |
Publication |
20-40 weeks after OMB approval |
Final Report |
42 weeks after OMB approval |
A.16-2 Interview Time Schedule – UTH/MDACC |
|
Activity |
Time Schedule |
Generate list of potential respondents |
1-2 weeks after OMB approval |
Contact potential respondent by phone to invite to participate in study(includes multiple attempts) |
2-4 weeks after OMB approval |
Interview respondents |
4-10 weeks after OMB approval |
Data entry and coding |
10-18 weeks after OMB approval |
Data analysis |
18–28 weeks after OMB approval |
Publications |
28-40 weeks after OMB approval |
Final Report |
42 weeks after OMB approval |
A.16-3 Focus Group Time Schedule – UTH/MDACC |
|
Activity |
Time Schedule |
Generate list of potential respondents |
1-2 weeks after OMB approval |
Contact potential respondent by phone to invite to participate in study(includes multiple attempts) |
2-4 weeks after OMB approval |
Hold focus groups |
4-8 weeks after OMB approval |
Data entry and coding |
8-14 weeks after OMB approval |
Data analysis |
14–24 weeks after OMB approval |
Publication |
28-36 weeks after OMB approval |
Final Report |
42 weeks after OMB approval |
17. Reason(s) Display of OMB Expiration Date is Inappropriate
The expiration date of OMB approval will be displayed. There is no requested exception.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
No exceptions to the certification are requested.
References
1. Committee on Quality of Health Care in America, Institute Of Medicine: Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, D.C., National Academy Press, 2001.
2. Kohn LT, Corrigan JM, Donaldson MS: To Err is Human: Building a Safer Health System. Washington, D.C., National Academy Press, 2000.
3. Allgar VL, Neal RD: Delays in the diagnosis of six cancers: analysis of data from the National Survey of NHS Patients: Cancer. Br J Cancer 92:1959-70, 2005.
4. Allgar VL, Neal RD: General practitioners' management of cancer in England: secondary analysis of data from the National Survey of NHS Patients-Cancer. Eur J Cancer Care (Engl) 14:409-16, 2005.
5. Neal RD, Allgar VL: Sociodemographic factors and delays in the diagnosis of six cancers: analysis of data from the "National Survey of NHS Patients: Cancer". Br J Cancer 92:1971-5, 2005.
6. Abel, G.A., Friese, C.R., Magazu, L.S., Richardson, L.C., Fernandez, M.E., De Zengotita, JJ, Earle, CC. Delays in referral and diagnosis for chronic hematologic malignancies: A literature review. Leukemia and Lymphoma. 2008;49(7): 1352 – 1359.
7. Nassur R, Mangel J, Chin-Yee I: Delays in the Cancer Pathway from Symptom Onset to Initiation of Treatment - A Retrospective Study in Patients with Non-Hodgkin's Lymphoma. Blood 108, 2006.
8. Kyle RA, Gertz MA, Witzig TE, et al: Review of 1027 patients with newly diagnosed multiple myeloma. Mayo Clin Proc 78:21-33, 2003.
9. Summerfield GP, Carey PJ, Galloway MJ, et al: An audit of delays in diagnosis and treatment of lymphoma in district hospitals in the northern region of the United Kingdom. Clin Lab Haematol 22:157-60, 2000.
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Part A, Page
| File Type | application/msword |
| Author | kathi Wilson |
| Last Modified By | arp5 |
| File Modified | 2009-12-09 |
| File Created | 2009-12-09 |