Request for Approval

Request for genIC Approval

CDC/ATSDR Formative Research and Tool Development

0920-1154

CIO: CDC/NIOSH/RHD

PROJECT TITLE: Development of an updated B Reader Certification Examination

PURPOSE AND USE OF COLLECTION: NIOSH has maintained and administered a training and certification program for licensed physicians to demonstrate competence in the International Labour Office (ILO) system to classify chest radiographs for dust-related diseases (the pneumoconioses) since the 1970s. The medical imaging field has evolved from analog film radiography to digital radiography over the past 15 years. In response to this shift, NIOSH has recently developed a draft of an updated B Reader Training Syllabus and Certification Examination (2019 Digital B Reader Exam) based upon digitally-acquired chest radiographic images. In order to ensure that the draft 2019 Digital B Reader Exam performs in a similar manner to the existing examination (Analog-based B Reader Exam) that has been in existence for the last 40 years, NIOSH is proposing to administer the 2019 Digital B Reader Exam among physicians who are scheduled to take the Analog-based B Reader Exam. This will allow for a back-to-back comparison of performance and scoring to ensure the 2019 Digital B Reader Exam is comparable to the Analog-based B Reader Exam. Taking the 2019 Digital B Reader Exam will be completely voluntary and results of the 2019 Digital B Reader Exam, among those who participate, will not impact their overall certification outcome. Certification will be based solely on the physician’s performance on the Analog-based B Reader Exam.

DESCRIPTION OF RESPONDENTS:

Respondents will be licensed physicians who are interested in becoming NIOSH-Certified B Readers and have contract NIOSH to schedule a time to sit for the Analog-based B Reader Exam. Typically, this includes U.S.-licensed physicians with a clinical specialties in radiology, internal medicine/pulmonary and critical care, or occupational medicine, however physicians with other clinical specialties as well as physicians licensed in other countries frequently take the examination.

CERTIFICATION:

I certify the following to be true:

1. The collection is voluntary.

2. The collection is low-burden for respondents and low-cost for the Federal Government.

3. The collection is non-controversial and does not raise issues of concern to other federal agencies.

4. Information gathered will not be used to substantially inform influential policy decisions.

5. The study is not intended to produce results that can be generalized beyond its scope.

Name: _Cara N. Halldin___________________

To assist review, please answer the following questions:

Personally Identifiable Information:

1. Is personally identifiable information (PII) collected? [ X ] Yes [ ] No

2. If Yes, is the information that will be collected included in records that are subject to the Privacy Act of 1974? [ X ] Yes [ ] No

3. If Applicable, has a System or Records Notice been published? [ X ] Yes [ ] No

Gifts or Payments:

Is an incentive (e.g., money or reimbursement of expenses, token of appreciation) provided to participants? [X ] Yes [ ] No

BURDEN HOURS

Category of Respondent	Form Name	No. of Respondents	Participation Time (minutes)	Burden in Hours
Physician test takers traveling to the NIOSH facility to take the exam	2019 Digital B Reader Exam	25	240	100
Physician test takers that NIOSH staff will travel to an academic or medical institution near their home and provide the exam	2019 Digital B Reader Exam	25	240	100
Totals		50	240	200

FEDERAL COST: The estimated annual cost to the Federal government is $52,075

If you are conducting a focus group, survey, or plan to employ statistical methods, please provide answers to the following questions:

The selection of your targeted respondents

1. Do you have a customer list or something similar that defines the universe of potential respondents and do you have a sampling plan for selecting from this universe? [ ] Yes [X] No

If the answer is yes, please provide a description of both below (or attach the sampling plan)? If the answer is no, please provide a description of how you plan to identify your potential group of respondents and how you will select them?

NIOSH currently administers the B Reader Examination at their facility in Morgantown and through various off-site courses and examination opportunities. The attendees of these courses as well as those who contact NIOSH and schedule an examination over the next 6-12 months will be the potential group of respondents. Physicians attending offsite course/examinations as well as physicians traveling to Morgantown will be invited to take the draft 2019 Digital B Reader Exam after they complete the Analog-based B Reader Exam.

Administration of the Instrument

1. How will you collect the information? (Check all that apply)

[ ] Web-based or other forms of Social Media

[ ] Telephone

[X] In-person

[ ] Mail

[X] Other, Explain

The B Reader Examination consists of no more than 80 chest radiographs that the physician must classify using the ILO standards for classifying pneumoconiosis. Viewing of radiographs and input of classification answers is completed electronically using a software called BViewer© that is designed and maintained by NIOSH and aligns with CDC/NIOSH (M) 2.8 form which is used to classify chest radiographs for pneumoconiosis (included in this packet. BViewer© software mimics this form in electornic format and is used to collect the chest radiograph classifications during the examination. Finally, a set of 25 multiple choice questions, testing the physicians knowledge of pneumoconiosis and the ILO system, will be completed by the physician at the end of the examination.

2. Will interviewers or facilitators be used? [ X ] Yes [ ] No

A facilitator is used to escort the physician to the testing computer lab and make sure there are no technical difficulties during the examination.

Please make sure all instruments, instructions, and scripts are submitted with the request.

Enclosed:

1. Attachment 1: Screen shots of the BViewer© computer software used for testing

2. Attachment 2: CDC/NIOSH (M) 2.8: Radiograph interpretation form

3. Attachment 3: Script inviting participation via phone or email

4. Attachment 4: Example of multiple choice test questions

5. Attachment 5: CDC/NIOSH (M) 2.12 CWHSP Physician Certification Form

6. Attachment 6: Non-research determination

Instructions for completing genIC Request for Approval for

CDC/ATSDR Formative Research and Tool Development

TITLE OF INFORMATION COLLECTION: Provide the name of the collection that is requested.

PURPOSE and USE: Provide a brief description of the purpose of this collection and how it will be used. If this is part of a larger study or effort, please include this in your explanation.

DESCRIPTION OF RESPONDENTS: Briefly describe the targeted group/groups for this collection.

CERTIFICATION: Please read the certification carefully. If you incorrectly certify, the collection will be returned as improperly submitted or it will be disapproved.

Personally Identifiable Information: Provide answers to the questions.

Gifts or Payments: If you answer yes to the question, please describe the incentive and provide a justification for the amount.

BURDEN HOURS:

Category of Respondents: Identify who you expect the respondents to be in terms of the following categories: (1) Individuals or Households; (2) Private Sector; (3) State, local, or tribal governments; or (4) Federal Government. Only one type of respondent can be selected.

Form: Provide the title of the information collection form.

No. of Respondents: Provide an estimate of the Number of respondents.

Participation Time: Provide an estimate of the amount of time required for a respondent to participate (e.g. fill out a survey or participate in a focus group).

Burden in Minutes: Multiply the Number of responses and the participation time and divide by 60.

FEDERAL COST: Estimate the annual cost to the Federal government for this collection.

If you are conducting a focus group, survey, or plan to employ statistical methods, please provide answers to the following questions:

The selection of your targeted respondents. Please provide a description of how you plan to identify your potential group of respondents and how you will select them. If the answer is yes, to the first question, you may provide the sampling plan in an attachment.

Administration of the Instrument: Identify how the information will be collected. More than one box may be checked. Indicate whether there will be interviewers (e.g. for surveys) or facilitators (e.g., for focus groups) used.

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