Developing a Biostatistical Collaboration Course in a Health Science Research Methodology Program

Figures & data

Figure 1: Educational model for Health Research Methodology (HRM) Program

Table 1: Course Outline: Session Objectives and Key References

Session Topic	Objectives	Key References
Introduction to Statistical Consulting	To discuss •         The ethical norms of statistician profession •         The role of statistics in science •         The role of statistician in research ethics	•         American Statistical Association. Ethical standards for statistical practice: Report of the ad hoc committee on professional ethics. The American Statistician 1983; 37: 5–6. •         Engeman RM, Shumake SA. Animal welfare and the statistical consultant. American Statistician 1983; 47: 229–33. •         Hooke R. Getting people to use statistics properly. The American Statistician 1980; 34: 102–7. •         American Statistical Association. Ethical Guidelines for Statistical Practice. 1999. http://ww2.amstat.org/profession/index.cfm?fuseaction=ethicalstatistics (accessed July 14, 2004)
Statistical Consulting Environment	To discuss •         The role of the statistician within a scientific environment •         Communicating with researchers from other disciplines	•         Boen JR. A self-supporting University statistical consulting center. American Statistician 1982; 36: 321–5. •         Cameron JM. The statistical consultant in a scientific laboratory. Technometrics 1969; 11: 247–4. •         Daniel C. Some general remarks on consulting in statistics. Technometrics 1969; 11: 241–5. •         Kirk RE. Statistical consulting in a university: dealing with people and other challenges. The American Statistician 1991; 45: 28–33. •         Meier P. Damned liars and expert witnesses. Journal of the American Statistical Association (JAMA) 1986; 71: 269–76.
Communication Skills	To discuss how •         How to write statistical reports •         How to make effective presentations •         PowerPoint presentations •         Effective verbal and non-verbal communication	•         Ehrenberg ASC. Writing technical papers or reports. The American Statistician 1982; 36: 326–9. •         Zahn DA, Isenberg DJ. Nonstatistical Aspects of Statistical Consulting, The American Statistician 1983; 37: 297–302. •         Day RA. How to Write and Publish a Scientific Paper. Oryx: Phoenix, 1994 •         Ehrenberg ASC. Rudiments of numeracy. Journal of the Royal Statistical Society 1977; A140: 277–97. •         Hoadley RB, Kettenring JR. Communication between statisticians and engineers/physical scientists’, Technometrics 1990; 32: 243–74. •         McDonald GC. Communicating with managers. Chance 1988; 1: 42–4.
Statistics and Ethics: Case Studies	This session covers the role of a statistician and techniques used in •         Clarifying research questions/ hypotheses •         Determining study designs ◯  use of Placebo controls in RCTs •         Determination of outcomes ◯  surrogate Outcomes versus Clinical outcomes ◯  composite Outcomes versus individual outcomes	•         Feemantle N, Calvert M, Wood J, Eastaugh J, Griffin C. Composite Outcomes in Randomized Trials: Greater precision but with greater uncertainty. JAMA 2003; 289(19): 2554–9 •         Cannon CP. Clinical perspectives on the use of composite endpoints. Controlled Clinical Trials 1997; 18(6): 517–29 •         Lubsen J, Kirwan B-A. Combined end points: can we use them? Statistics in Medicine2002; 21: 2959–70 •         CBC News Investigation: The Secret Life of Dr Chandra. Parts 1, 2 and 3. http://www.cbc.ca/national/news/chandra/ (date of last access: January 1, 2007)
Methodological Issues I: Reporting of Scientific Publications	This session will cover •         Issues of how to report results of scientific studies. In particular, we focus on the role of a statistical collaborator in ensuring appropriate reporting standards on design methods, analysis and results •         Discussions of authorship issues.	•         The CONSORT Statement. Lancet 2001; 357: 1191–4. •         The STARD Statement. Annals of Internal Medicine 2003; 138: 40–5. •         The TREND Statement. American Journal of Public Health 2004;94(3):361–6. •         The MOOSE Statement. JAMA 2000; 283: 2008–12 •         The QUOROM Statement. Lancet 1999; 354:1998–1900. •         Lang TA, Secic M. How to report Statistics in Medicine. American College of Physician Medical Writing and Communication. American College of Physician. Philadelphia, PA: 2003. (2^nd edition was published in 2006) •         Rennie D, Yank V, Emanuel LL. When authorship fails: A proposal to make contributors accountable. JAMA 1997; 278:779–85.
Methodological Issues II: Sample Size Issues	This session covers techniques for •         Eliciting information from clinician collaborators to calculate sample size •         Reporting of the results of the calculation in a ◯  protocol for granting agency or Research Ethics Submission, ◯  abstract for a scientific meeting ◯  manuscript for publication.	Bland JM, Altman DG. One and two sided tests of significance. British Medical Journal 1994; 309: 248. •         Dubey SD. Some Thoughts on the One-sided and Two-sided Tests. Journal of Biopharmaceutical Statistics 1991; 1:139–50. •         Chow S-C, Shao J, Wang H. Sample Size Calculations in Clinical Research. Marcel Dekker: New York, NY 2003. •         Day RA. How to Write and Publish a Scientific Paper. Oryx: Phoenix, AZ, 1994.
Video Practice Session I	This session will involve video-taping of a practice session with a clinician researcher with discussion on the experience. •         The objective is to allow the students to put some skills into practice while others learn by observing. The video-tapes will form the basis for discussion of the experiences afterwards.	•         Derr J. Statistical Consulting: A Guide to Effective Communication. Duxbury Press: New York, NY 2000.
Computational Aspects	This session will involve a lab and discussions of •         Different features of common and special statistical software such as ◯  SAS, STATA, SPSS, MINITAB and others such as StatXact, LogXact ◯  Special Software for sample size calculation, meta-analysis, ◯  WinBUGS •         Different features of database design/management software ◯  ACCESS ◯  Teleform	Respective Software Manuals
Video Practice Session II	This session will be a second video-taping of a practice session with a clinician researcher with discussion on the experience; •         The objective is to allow the students a second opportunity to put some skills into practice while others learn by observing. The video-tapes will form the basis for discussion of the experiences afterwards.	•         Derr J. Statistical Consulting: A Guide to Effective Communication. Duxbury Press: New York, NY 2000.
Consulting Experience/Project (3 weeks)	The weeks corresponding to these sessions are dedicated to formal internship for experiential learning	None Assigned
Career Development	•         How to create and maintain a curriculum vitae (CV); •         Aspects considered in evaluation of CVs for promotion, career awards, research awards and so on; •         How to create and maintain a teaching dossier (TD); •         Aspects considered in evaluation of one's contributions to education through a TD; and •         Strategies for career development; •         Strategies for improving publication record.	•         Thabane L, Thabane M, Goldsmith CH. Mentoring Young Statisticians: Facilitating the Acquisition of Important Survival Skills African Journal of Statistics 2006;2:31–42 •         Hemenway D: Authors and authorship (Letter). American Journal of Public Health 2998;88(5):826–7 •         Goldsmith CH. Strategies for Making your Curriculum Vita Numerical and Graphical for Promotion, Tenure and Career Awards (unpublished paper presented at the Joint Statistical Meeting in Seattle, Washington USA: Session 210, 2006-Aug-07, Biopharmaceutical Section Abstract Number: 307578)
Project Presentations	This session will be used for presentations of projects that students were part of during the internship. •         NOTE: The projects can be based on design of new studies or data analysis.	None Assigned

Table

1	Ability to translate research questions into statistical questions	1     2     3     4     5     6     7
2	Ability to assist with study design issues	1     2     3     4     5     6     7
3	Ability to assist with statistical analysis issues	1     2     3     4     5     6     7
4	Ability to assist with interpretation and reporting of results	1     2     3     4     5     6     7
5	Ability to adapt existing statistical methods to solve research questions	1     2     3     4     5     6     7
6	Ability to develop or contribute to the development of grant proposal	1     2     3     4     5     6     7
7	Ability to communicate biostatistical concepts effectively to non-statisticians	1     2     3     4     5     6     7

Table

	Overall Rating	Specific Strengths	Areas for Improvement
1	Listening skills •        Commendable •        Fine •        Needs improvement
2	Organization •        Commendable •        Fine •        Needs improvement
3	Clarify of communicating advice •        Commendable •        Fine •        Needs improvement
4	Timeliness •        Commendable •        Fine •        Needs improvement
5	Effectiveness as a biostatistical collaborator •        Commendable •        Fine •        Needs improvement

Table

1	Ability to translate research questions into statistical questions	1     2     3     4     5     6     7
2	Ability to assist with study design issues	1     2     3     4     5     6     7
3	Ability to assist with statistical analysis issues	1     2     3     4     5     6     7
4	Ability to assist with interpretation and reporting of results	1     2     3     4     5     6     7
5	Ability to adapt existing statistical methods to solve research questions	1     2     3     4     5     6     7
6	Ability to develop or contribute to the development of grant proposal	1     2     3     4     5     6     7
7	Ability to communicate biostatistical concepts effectively to non-statisticians	1     2     3     4     5     6     7