0341_SS_Part B_2017

B. Statistical Methods (used for collection of information employing statistical methods)

1. Respondent Universe and Sampling Methods, and

2. Procedures for the Collection of Information

The organizations and individuals to whom Safety Communications are directed depend upon the subject of the Safety Communication. Thus, the population of interest is variable and the Safety Communication is sent electronically.

Sample size will be determined by the number of volunteer respondents. In the case of the questionnaire survey proposed, the desired precision can be expressed as being confident that, in 95 out of 100 cases where the sample is drawn in the same manner as was the current sample, the obtained response in a replicative survey (e.g., a percentage of the sample asserting a particular perception about a Safety Communication) would be within the range of 10 percentage points above or below (i.e., +- 10%) the response (the percentage) obtained in the present survey.

Following completion of data collection, frequencies and percent distributions will be calculated for questionnaire items, and open-ended items will be categorized by content. The following estimates will be calculated using standard descriptive measures such as frequency tables and cross-tabulations:

1. Estimate of prevalence of use of Safety Communication information by health care providers and patients

2. Estimate of various actions taken by health care providers and patients as a result of information contained in Safety Communications

3. Evaluation of respondent suggestions for improving the Safety Communication

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

Explaining the importance of the study and value to the respondent is designed to maximize response rates. Since the survey will be conducted electronically on a volunteer basis, there is no plan for dealing with nonresponse.

4. Test of Procedures or Methods to be Undertaken

The proposed questionnaire was shown to several personnel in two national health care organizations, along with FDA staff knowledgeable in areas of survey design, questionnaire development, and writing/editing. All of these inputs contributed to the phrasing, format and topical items included in the final version of the questionnaire.

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

The data will be collected and analyzed by the FDA. When this survey was originally proposed, employees in CDRH’s Office of Surveillance and Biometrics were consulted with regard to statistical methods. CDRH/OCE will collect the surveys and arrange for analysis.

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