## MS Project: New Statistical Methods

The typical length of a MS project will be 10 or more double-spaced pages.

1. ABSTRACT: A brief summary (150 words) should state the purpose of the methods and the main approach.
2. INTRODUCTION: This section should describe the purpose of research, and possibly the previous work the research builds on including:
1. Justify why the research is needed.
2. Briefly summary of the literature on previous work in this area.
3. Present the objectives of the study.
3. STATISTICAL METHODOLOGY: This section should describe the statistical approaches. The section should clarify the extent to which the proposed method has theoretical justification, and why it is superior to current methods.
4. IMPLEMENTATION: This section describes the methods (usually software) used for implementation. Preferably, the programs used are attached as an Appendix.
5. APPLICATION: At least one application of the method should be presented. Some details should be given on the particular setting, source of data, etc. first. The new methods should then be applied and compared to application of current approaches, if any exist.
6. DISCUSSION: Discuss potential implications of the new methods. Describe and limitations and areas for further research.
7. TABLES: If the new methods generate statistical thresholds for tests or measures of size / power, present some tables of representative values.
8. FIGURES [May or may not be Helpful for a Masters Projects]
9. CITED REFERENCES

## MS Project: Study Protocol for a Clinical Trial

The typical length of a MS project is 10 pages double-spaced, with the following elements.

1. ABSTRACT: A brief summary (100 - 250 words ) of the design appears at the front. This should state the purpose of research and its main design elements.
2. BACKGROUND OF STUDY: Contains scientific information on why disease is important and why the treatment might work
3. OBJECTIVES: Documents what the study proponents hope to achieve. Detail includes:
1. PRIMARY QUESTION/RESPONSE VARIABLE
2. SECONDARY QUESTION/RESPONSE VARIABLES
3. SUBGROUP HYPOTHESES
4. STUDY POPULATION: Describe the individuals to whom the treatment will be given in practice. Details should include:
1. INCLUSION/EXCLUSION CRITERIA
2. SAMPLE SIZE / POWER ESTIMATES This Section Required for a MS project.
5. ENROLLMENT OF SUBJECTS: Describe how subjects will be identified, screened and enrolled. Include descriptions of
1. INFORMED CONSENT
2. ASSESSMENT OF ELIGIBILITY
3. BASELINE INFORMATION
4. RANDOMIZATION SCHEME This Section Required for a MS project.
6. INTERVENTION: Describe the intervention and delivery as it will be given in practice, including the following elements:
1. DESCRIPTION AND SCHEDULE
2. MEASURES OF COMPLIANCE
7. FOLLOW-UP VISIT DESCRIPTION AND SCHEDULE - Describe how all needed information will be obtained and how loss to follow up will be minimized.
8. ASCERTAINMENT OF RESPONSE VARIABLES: Please provide details on the following areas:
1. TRAINING
2. DATA COLLECTION
3. DATA MONITORING AND QUALITY CONTROL
4. DATA ANALYSIS: Give the specific approaches that will be used for adjusted and unadjusted analysis of data, and in particular for the primary outcome of interest. This Section Required for a MS project.
5. TERMINATION POLICY
9. ORGANIZATION: This section is very important, since a great deal of the success of a protocol depends on management. Please include these elements:
1. PARTICIPATING INVESTIGATORS: Verify that the appropriate people are doing the appropriate things.
2. STUDY ADMINISTRATION, with committees and subcommittees, including the policy and data monitoring committee.
3. CITED REFERENCES: Cite all articles and sources where background and other information was obtained.

NOTE: Protocols for studies that are not clinical trials may have slightly different formats.

## MS Project

### Statistics MS Project

The Statistics MS project is designed to demonstrated the ability to undertake planning and conducting statistical research, and communicating plans and results in writing.

The Masters project should be completed in one of the classes the student takes. Several core Statistics and Biostatistics MS classes give data analysis or study planning assignments which require writing a report that (depending on how well the student does) fulfills the Masters project requirements. Student should check with teachers of the course on whether a particular assignment of that class meets these requirements.

The format of a report depends on the type of statistical research, design, or analysis that is done for the project. Most Masters projects will fall into one of the following three categories.

1. Statistical Analysis of Data Using statistical methods to analyze data for a focused problem of interest and communicating findings in a manner to advance the substantive field. The student is also expected to also write the programs used to analyze the data.

LINK TO TYPICAL FORMAT FOR STATISTICAL ANALYSIS OF DATA

2. Protocols for Statistical Research (Typically Clinical Trials) Development of study plans or draft study designs to be used to obtain approval or funding or to undertake applied statistical research. The student is also expected to use statistical software (or otherwise) to obtain power / sample size estimates.

LINK TO TYPICAL FORMAT FOR STUDY PROTOCOL

3. Development of Statistical Methods or New Applications Development of new statistical methods or application of current statistical methods to a new area. The student is expected to contribute substantially to the development and/or the application. [As this may be more challenging than the other two types of projects, it is not expected that many Masters Projects would involve this].

LINK TO TYPICAL FORMAT FOR NEW STATISTICAL METHOD/APPLICATION

The formats described above for each of these Types of Masters projects are suggestions, not strict requirements. The teacher of a class (in consultation with other faculty) has discretion on whether a written report fulfills the Masters Report requirement and Masters Projects that do not fall exactly into the above formats are possible. Still, any Masters Project should require students to undertake statistical research or planning and written communication at equivalent levels to these formats.

## MS Project: Statistical Analysis of Data

The typical length of a MS project is 10 pages double-spaced, with the following elements.

1. ABSTRACT: A brief summary (100 - 250 words ) of research appears at the front. This should state the purpose of research and its main findings.
2. INTRODUCTION: Describe the purpose of research, and possibly the previous work the research builds on, including:
1. justifying why the research needed.
2. summarizing the literature on previous work in this area.
3. listing the objectives of the study.
3. METHODS: Describe the conduct of the study, including how the data were collected, analyzed, etc, including:
1. General study design (was it an experiment, a case-control, or cohort study, etc.)
2. Description of the Study Participants or Objects: the study population, sampling frame, criteria for inclusion and exclusion, and the method for selecting study subjects.
4. DATA COLLECTION: Describe variables, measurement techniques, and validity/reliability of instruments. One could also describe quality control procedures and/or methods used to minimize loss of information.
5. STATISTICAL METHODS: A brief description of the statistical tests and software used to do the analysis.
6. RESULTS: For studies involving people the results are often presented in the following order.
1. Descriptive data: study population described according to demographic/socio-economic variables such as age, income, education, health status, etc.
2. Crude (unadjusted) measures of Association: Relative risks from 2x2 tables, coefficients from univariate models, comparisons of group means by t-tests, etc.
3. Stratified analyses and Simple Methods of Adjustment: For example, separate relative risks, t-tests, etc. by racial group.
4. More complicated analyses with multivariate models: linear regression, logistic regression, proportional hazards, etc.

Analogous presentations of results would be made for other types of studies.
7. DISCUSSION This section interprets the results and explains the implications and limitations. Often (but not always) this involves the following in this order:
1. A brief summary of the findings.
2. A short review of the literature, contrasting with the study findings [May not be Necessary for Most Masters Projects]
3. Discussion of strengths and limitations of the study.
4. Implications for policy. What impact could these findings have on the way things are done now? [May not be Necessary for Most Masters Projects]
5. Suggestions for future studies. Could shortcomings of this study be improved on in future research. [May not be Necessary for Most Masters Projects]
8. CITED REFERENCES
9. TABLES [Usually any Masters Report of Data Analysis will have at least one table of important results]
10. FIGURES [May or may not be Helpful for a Masters]
11. APPENDIX [OPTIONAL] Students may want to attach a copy of the computer program used to do the data analysis.

## Schedule and Book List for the Upcoming Semester

The Registrar's office makes available specific course schedules for specific terms. Our department maintains a list with instructors for the current semester and expected instructors for the upcoming semester.

Books for our courses are generally ordered through the Ferren Mall bookstore . From this link, choose the Ferren Mall bookstore, and then choose books and then textbooks, and request books for our department, coded as 960.