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"Publication of the results of an original scientific study entails producing a manuscript with content that reflects a well-designed, well-executed research question. It is a well-written description of the process, the results, and the wide implications."

—Andrew S. Wechsler, MD, Editor, The Journal of Thoracic and Cardiovascular Surgery

Background information
Study design
Statistics

Background information

http://www.facs.org/oebs/src/clintrialbib.html
Comprehensive bibliography that covers all of the topics you could possibly need to consider

Study design

Birkmeyer JD. Outcomes research and surgeons. Surgery 1998; 124:477-483.
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Browner WS. Publishing and Presenting Clinical Research. Philadelphia. Lippincott Williams & Wilkins. 1999
Clinical Study Design and Methods Terminology: http://www.vetmed.wsu.edu/courses-jmgay/GlossClinStudy.htm
Cummings SR, Browner WS, Hulley SB. Conceiving the research question. In: Hulley SB, Cummings SR, editors.
Designing Clinical Research. Baltimore: Williams and Wilkins, 1988:12-17.
Hall GM. The structure of a scientific paper. 1997; London. British Medical Journal.
Hulley SB (Ed). Designing Clinical Research: An Epidemiologic Approach. Philadelphia. Lippincott Williams & Wilkins Publishers 2001.
Norton, JA et al. Surgery, Basic Science and Clinical Evidence. Springer-Verlag 2000.
Souba WW, Wilmore DW. Surgical Research. ? Academic Press. 2001. ( http://www.harcourt-international.com/catalogue/title.cfm?ISBN=0126553300 )
Statistics at Square One: http://bmj.bmjjournals.com/collections/statsbk/13.shtml

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Statistics

Altman DG. Practical Statistics for Medical Research. CRC Press 1990
Altman DG, Dore CJ. Randomisation and baseline comparisons in clinical trials. Lancet 1990;335:149-53.[ Medline ]
Bailar JC III, Mosteller F. Guidelines for statistical reporting in articles for medical journals. Ann Intern Med 1988;108:266-73.[ Medline ]
Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, et al. Improving the quality of reporting of randomized controlled trials: the CONSORT statement. JAMA 1996;276:637-9.[ Medline ]
Berger VW, Exner DV. Detecting selection bias in randomized clinical trials. Controlled Clin Trials 1999; 20:319-327.[ Medline ]
Bland JM, Altman DG. Multiple significance tests: the Bonferroni method. BMJ 1995;310:170.[ Free Full Text ]
Braitman LE. Confidence intervals extract clinically useful information from data. Ann Intern Med 1988;108:296-8.[ Medline ]
Braitman LE. Confidence intervals assess both clinical significance and statistical significance. Ann Intern Med 1991;114:515-7.[ Medline ]
Braitman LE, Davidoff F. Predicting clinical states in individual patients. Ann Intern Med 1996;125:406-12.[ Medline ]
Brown BW, Jr. Statistical controversies in the design of clinical trials. Cont Clin Trials 1980; 1:13-27.
Concato J, Feinstein AR, Holford TR. The risk of determining risk with multivariable models. Ann Intern Med 1993;118:201-10.[ Medline ]
Davis CE. Secondary endpoints can be validly analyzed, even if the primary endpoint does not provide clear statistical significance. Controlled Clinical Trials 1997;18:557-560.[ Medline ]
Everitt BS. The Cambridge dictionary of statistics in the medical sciences. Cambridge, UK: Cambridge University Press; 1995.
Gardner MJ, Altman DG. Confidence intervals rather than P values: estimation rather than hypothesis testing. BMJ 1986;292:746-50.[ Medline ]
Gardner MJ, Machin D, Campbell MJ. Use of check lists in assessing the statistical content of medical studies. BMJ 1986;292:810-2.[ Medline ]
Goodman SN, Berlin JA. The use of predicted confidence intervals when planning experiments and the misuse of power when interpreting results. Ann Intern Med. 1994;121:200-206.[ Medline ]
Johnson AG. Removing bias in surgical trials. BMJ 1997; 314:916-917.[ Medline ]
Kleinbaum DG, Kupper LL, Morgenstern H. Epidemiologic research: principles and quantitative methods. New York: John Wiley & Sons; 1982.
Lang T, Secic M. How to report statistics in medicine. A Guide for Authors, Editors, and Reviewers. 1997; Philadelphia: American College of Physicians. http://www.statsoftinc.com/textbook/esc1.html
Meinert CL. Clinical trials dictionary: terminology and usage recommendations. Baltimore: Johns Hopkins University; 1996.
Piantadosi S. Clinical trials: a methodologic perspective. New York: John Wiley & Sons; 1997.
Sackett DL, Haynes RB, Tugwell P. Clinical epidemiology: a basic science for clinical medicine. 2nd ed. Philadelphia: Lippincott-Raven: 1991.
Salsburg DS. The religion of statistics as practiced in medical journals. Am Stat 1985;39:220-3.
Simon R. Confidence intervals for reporting results of clinical trials. Ann Intern Med 1986;105:429-35.[ Medline ]
Wilkinson L. Graphical displays. Stat Methods Med Res 1992;1:3-25.[ Medline ]
Yusuf S, Wittes J, Probstfield J, Tyroler HA. Analysis and interpretation of treatment effects in subgroups of patients in randomized clinical trials. JAMA 1991;266:93-98.[ Abstract ]