. 2021 Jul 22;22:478. doi: 10.1186/s13063-021-05427-x

Table 2.

Lecture topics and practice, contents, and references for the Module

Topic/practice	Contents	Key references
Biostatistical collaboration in health research	• Understanding the role of a statistician in health research collaborations • Negotiating your role in collaborations • How to balance service versus leadership roles • Dealing with difficult ethical dilemmas	• 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://www.amstat.org/profession/index.cfm?fuseaction=ethicalstatistics
Communication (verbal, written and presentations)	• The art of asking questions in collaborations • The do’s and don’ts of communication in collaborative research • Understanding the clinical environment and culture of your collaborators • Getting your collaborators to understand your statistical and social culture • How to give a technical talk to a non-statistician audience	• 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.
How to frame researchable questions	• Discussing the importance of framing research questions appropriately • Helping your collaborators to frame researchable questions	• Thabane L, Thomas T, Ye C, Paul J. Posing the research question: not so simple. Canadian Journal of Anesthesia 2009; 56: 71-9 • Rios LP, Ye C, Thabane L. Association between framing of the research question using the PICOT format and reporting quality of randomized controlled trials. BMC Medical Research Methodology 2010: 10: 11 • Sackett DL, Wennberg JE. Choosing the best research design for each question. BMJ. 1997; 315(7123): 1636.
Determinants of a successful career development in collaborative research	• Understanding the importance of key determinants of career development success in collaborative research: mentorship, time-management, stress-management, conflict-resolution, managing meetings, etc. • Understanding why, and how to choose a mentor • Discussing co-authorship with collaborators • How to stay abreast with developments in the field	• Sackett DL. On the determinants of academic success as a clinician-scientist. Clin Invest Med 2001;24:94-100. • Sackett DL. Clinician-trialist rounds: 3. Priority setting for academic success. Clinical Trials. 2011; 8: 235-7. • Oxman AD, Sackett DL. Clinician-trialist rounds: 14. Ways to advance your career by saying ‘no’–part 2: When to say ‘no’, and why. Clinical Trials 2013;10:181-187. • Oxman AD, Sackett DL. Clinician-trialist rounds: 15. Ways to advance your career by saying ‘no’–part 3: how to say ‘no’, nicely. Clinical Trials 2013;10:340-343. • Odueyungbo A, Thabane L. Mentoring in biostatistics: some suggestions for reform. Journal of multidisciplinary healthcare 2012;5:265. • Sambunjak D, Straus SE, Marušić A. Mentoring in academic medicine: a systematic review. JAMA 2006;296:1103-1115.
Writing protocols, sample size justification, statistical analysis plans, book reviews, manuscript and grant reviews.	• Understanding how to review and write statistical sections of study protocols • Understanding how to write a statistical analysis plan (SAP) • Understanding how to write a book review • Understanding how to review manuscripts, protocols, grants, and SAPs	• EQUATOR network. London: the Centre for Statistics in Medicine, NDORMS, University of Oxford; 2016. Available from http://www.equator-network.org/. • Chan AW, Tetzlaff JM, Gøtzsche PC et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ 2013;346:e7586. • Gamble C, Krishan A, Stocken D et al. Guidelines for the content of statistical analysis plans in clinical trials. JAMA 2017;318:2337-2343. • Thabane L, Ma J, Chu R et al. A tutorial on pilot studies: the what, why and how. BMC medical research methodology 2010;10:1.
Reporting of studies	• Understanding the importance of good reporting in science • Understanding how to report studies of different designs including observational studies, RCTs, pilot trials, pragmatic trials	• Nicholls SG, Langan SM, Benchimol EI, Moher D. Reporting transparency: making the ethical mandate explicit. BMC medicine 2016;14:44. • Li G, Bhatt M, Wang M, Mbuagbaw L, Samaan Z, Thabane L. Enhancing primary reports of randomized controlled trials: Three most common challenges and suggested solutions. Proceedings of the National Academy of Sciences 2018;115:2595-2599. • Li G, Abbade LP, Nwosu I et al. A scoping review of comparisons between abstracts and full reports in primary biomedical research. BMC medical research methodology 2017;17:181. • Li G, Abbade LP, Nwosu I et al. A systematic review of comparisons between protocols or registrations and full reports in primary biomedical research. BMC medical research methodology 2018;18:9. • Glasziou P, Altman DG, Bossuyt P et al. Reducing waste from incomplete or unusable reports of biomedical research. The Lancet 2014;383:267-276. • EQUATOR network. London: the Centre for Statistics in Medicine, NDORMS, University of Oxford; 2016. Available from http://www.equator-network.org/.
Special topics in trials	• How to generate a randomization schedule • Dealing with multiplicity issues in trials • Subgroup analyses in trials • Missing data in trials • Data safety monitoring boards • Common errors in study proposals or protocols	• Haynes BR, Sackett DL, Guyatt GH, Tugwell P. Clinical Epidemiology: How to do clinical practice research (3rd Edtion). Lippincott Williams & Wilkins, 2006 • Li G, Taljaard M, Van den Heuvel ER et al. An introduction to multiplicity issues in clinical trials: the what, why, when and how. International journal of epidemiology 2016;46:746-755. • Sun X, Ioannidis JP, Agoritsas T, Alba AC, Guyatt G. How to use a subgroup analysis: users’ guide to the medical literature. JAMA 2014;311:405-411. • Little RJ, D'agostino R, Cohen ML et al. The prevention and treatment of missing data in clinical trials. NEJM 2012;367:1355-1360. • Morse MA, Califf RM, Sugarman J. Monitoring and ensuring safety during clinical research. JAMA 2001;285:1201-1205.
Video sessions (live consultation sessions with collaborators)	• Understanding the importance of good communication skills in discussing research problems with collaborators	None

Topic/practice

Contents

Key references

Biostatistical collaboration in health research

• Understanding the role of a statistician in health research collaborations

• Negotiating your role in collaborations

• How to balance service versus leadership roles

• Dealing with difficult ethical dilemmas

• 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://www.amstat.org/profession/index.cfm?fuseaction=ethicalstatistics

Communication (verbal, written and presentations)

• The art of asking questions in collaborations

• The do’s and don’ts of communication in collaborative research

• Understanding the clinical environment and culture of your collaborators

• Getting your collaborators to understand your statistical and social culture

• How to give a technical talk to a non-statistician audience

• 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.

How to frame researchable questions

• Discussing the importance of framing research questions appropriately

• Helping your collaborators to frame researchable questions

• Thabane L, Thomas T, Ye C, Paul J. Posing the research question: not so simple. Canadian Journal of Anesthesia 2009; 56: 71-9

• Rios LP, Ye C, Thabane L. Association between framing of the research question using the PICOT format and reporting quality of randomized controlled trials. BMC Medical Research Methodology 2010: 10: 11

• Sackett DL, Wennberg JE. Choosing the best research design for each question. BMJ. 1997; 315(7123): 1636.

Determinants of a successful career development in collaborative research

• Understanding the importance of key determinants of career development success in collaborative research: mentorship, time-management, stress-management, conflict-resolution, managing meetings, etc.

• Understanding why, and how to choose a mentor

• Discussing co-authorship with collaborators

• How to stay abreast with developments in the field

• Sackett DL. On the determinants of academic success as a clinician-scientist. Clin Invest Med 2001;24:94-100.

• Sackett DL. Clinician-trialist rounds: 3. Priority setting for academic success. Clinical Trials. 2011; 8: 235-7.

• Oxman AD, Sackett DL. Clinician-trialist rounds: 14. Ways to advance your career by saying ‘no’–part 2: When to say ‘no’, and why. Clinical Trials 2013;10:181-187.

• Oxman AD, Sackett DL. Clinician-trialist rounds: 15. Ways to advance your career by saying ‘no’–part 3: how to say ‘no’, nicely. Clinical Trials 2013;10:340-343.

• Odueyungbo A, Thabane L. Mentoring in biostatistics: some suggestions for reform. Journal of multidisciplinary healthcare 2012;5:265.

• Sambunjak D, Straus SE, Marušić A. Mentoring in academic medicine: a systematic review. JAMA 2006;296:1103-1115.

Writing protocols, sample size justification, statistical analysis plans, book reviews, manuscript and grant reviews.

• Understanding how to review and write statistical sections of study protocols

• Understanding how to write a statistical analysis plan (SAP)

• Understanding how to write a book review

• Understanding how to review manuscripts, protocols, grants, and SAPs

• EQUATOR network. London: the Centre for Statistics in Medicine, NDORMS, University of Oxford; 2016. Available from http://www.equator-network.org/.

• Chan AW, Tetzlaff JM, Gøtzsche PC et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ 2013;346:e7586.

• Gamble C, Krishan A, Stocken D et al. Guidelines for the content of statistical analysis plans in clinical trials. JAMA 2017;318:2337-2343.

• Thabane L, Ma J, Chu R et al. A tutorial on pilot studies: the what, why and how. BMC medical research methodology 2010;10:1.

Reporting of studies

• Understanding the importance of good reporting in science

• Understanding how to report studies of different designs including observational studies, RCTs, pilot trials, pragmatic trials

• Nicholls SG, Langan SM, Benchimol EI, Moher D. Reporting transparency: making the ethical mandate explicit. BMC medicine 2016;14:44.

• Li G, Bhatt M, Wang M, Mbuagbaw L, Samaan Z, Thabane L. Enhancing primary reports of randomized controlled trials: Three most common challenges and suggested solutions. Proceedings of the National Academy of Sciences 2018;115:2595-2599.

• Li G, Abbade LP, Nwosu I et al. A scoping review of comparisons between abstracts and full reports in primary biomedical research. BMC medical research methodology 2017;17:181.

• Li G, Abbade LP, Nwosu I et al. A systematic review of comparisons between protocols or registrations and full reports in primary biomedical research. BMC medical research methodology 2018;18:9.

• Glasziou P, Altman DG, Bossuyt P et al. Reducing waste from incomplete or unusable reports of biomedical research. The Lancet 2014;383:267-276.

• EQUATOR network. London: the Centre for Statistics in Medicine, NDORMS, University of Oxford; 2016. Available from http://www.equator-network.org/.

Special topics in trials

• How to generate a randomization schedule

• Dealing with multiplicity issues in trials

• Subgroup analyses in trials

• Missing data in trials

• Data safety monitoring boards

• Common errors in study proposals or protocols

• Haynes BR, Sackett DL, Guyatt GH, Tugwell P. Clinical Epidemiology: How to do clinical practice research (3rd Edtion). Lippincott Williams & Wilkins, 2006

• Li G, Taljaard M, Van den Heuvel ER et al. An introduction to multiplicity issues in clinical trials: the what, why, when and how. International journal of epidemiology 2016;46:746-755.

• Sun X, Ioannidis JP, Agoritsas T, Alba AC, Guyatt G. How to use a subgroup analysis: users’ guide to the medical literature. JAMA 2014;311:405-411.

• Little RJ, D'agostino R, Cohen ML et al. The prevention and treatment of missing data in clinical trials. NEJM 2012;367:1355-1360.

• Morse MA, Califf RM, Sugarman J. Monitoring and ensuring safety during clinical research. JAMA 2001;285:1201-1205.

Video sessions (live consultation sessions with collaborators)

• Understanding the importance of good communication skills in discussing research problems with collaborators

None