Ss.b Cc

Supporting Statement B for

Impact of Clinical Research Training and Medical Education at the Clinical Center on Physician Careers in Academia and Clinical Research

Name: Linda Wisniewski

Address: 10 Center Drive, Room: 1 N252B

Bethesda, MD 20892

Telephone: 301-496-9425

Fax: 301-435-5275

Email: WisniewskiL@cc.nih.gov

Table of contents

B. COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS 1

B.1 Respondent Universe and Sampling Methods 1

B.2 Procedures for the Collection of Information

B.3 Methods to Maximize Response Rates and Deal with Non-response

B.4 Test of Procedures or Methods to be Undertaken

B.5 Individuals Consulted on Statistical Aspects and Individuals Collecting

and/or Analyzing Data

B.1 Respondent Universe and Sampling Methods

# of total entities (persons)	# in sample	Expected response rate for entity
Physicians	130	90%
Medical Students	60	90%
Dental Students	1	100%
Other	N/A	N/A

Expected response rate for collection as a whole:

Ninety (90)%

B.2 Procedures for the Collection of Information

The sample is the entire cohort of trainees enrolled annually in education programs administered by the Office of Clinical Research Training and Medical Education. This cohort includes clinical fellows, medical students and dental students. This approach is justified by: 1) external accreditation mandates requiring that all participants be surveyed; and 2) the relatively small number of total participants which allows complete sampling. Because the cohort consists of clinical fellows, medical students and dental students, the annual sampling will be done within each of these strata. Because the dental student numbers are small, however, this stratum may be combined with the medical student stratum for the purpose of data analysis as a category entitled “students”. No logistical or statistical problems related to sampling are anticipated with this approach and no specialized approach to sampling is required. No sampling intervals of less than one year duration are needed.

The data collection method is a survey containing questions allowing dichotomous responses or categorical responses arranged on likert scales. These questions would be subjected to simple quantitative analysis (percentages, means, standard deviation). Some questions will allow input of free text and would be subjected to qualitative analysis.

The survey will be administered and the information will be collected on-line. An e-mail with a link to the survey will be sent to participants. Non-participants will be sent reminder e-mails. The survey software will permit data analysis and summary reports. The Office of Clinical Research Training and Medical Education will be responsible for this process. Quality control will be the responsibility of the software’s vendor (Advanced Informatics, LLC, Minneapolis, Minnesota.

B.3 Methods to Maximize Response Rates and Deal with Nonresponse

Non-responders will be contacted by e-mail with reminders to complete the survey. These reminders will be sent monthly for a total of three months. Non-responders after three months will be categorized as non-participants and excluded from data analysis. The response rate for the survey will include all participants in the numerator and all eligible to participate in the denominator. Quantitative analysis of individual questions in the survey will be based on actual respondents, not potential respondents.

Based on our prior experience with similar on-line surveys administered to eligible physician participants at NIH by the Accreditation Council on Graduate Medical Education (ACGME), located in Chicago, IL, the aggregate response rate over three years has been 90%. The individual response rates are as follows: 94%, 94%, and 89%. In our experience, medical students are more likely to respond to similar surveys when compared with physicians. As such, we estimate that the medical student response rate will be at least 90%, and anticipate that it will be higher.

B.4 Test of Procedures or Methods to be Undertaken

No testing is proposed or planned for this survey.

B.5 Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data

Robert Lembo, MD, Office of Clinical Research Training and Medical Education, NIH Clinical Center, NIH. 301-496-2636.

Advanced Informatics, LLC, 10 Second Street NE, STE 300, Minneapolis, MN 55413 612‐253‐0130.

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