130515P - THE ROLE OF RESEARCH IN CLINICAL CARE

Presentation at the Research Day of the Women Specialist Hospital on Wednesday 15^th May 2013 by Professor Omar Hasan Kasule Sr. MB ChB (MUK), MPH (Harvard), DrPH (Harvard) omarkasule@yahoo.com

THE SCIENTIFIC METHOD & SCIENTIFIC RESEARCH

·         Clinical observations or problems generate hypotheses

·         Hypothesis: null hypothesis (H₀) and alternate hypothesis (H_A)

·         Study design, data collection, and data analysis

·         Reject (H₀) OR not Reject (H₀) – p value = chances that I reached conclusion in error

·         Generate and test new hypotheses

INTERPRETATION OF THE STATISTICALLY SIGNIFICANT TEST (p < 0.05)

·         H₀ is false

·         H₀ is rejected

·         Observations are not compatible with H₀

·         Observations are not due to sampling variation

·         Observations are real/true biological phenomena.

INTERPRETATION OF THE STATISTICALLY SIGNIFICANT TEST (p > 0.05)

·         H₀ is not false (we do not say true)

·         H₀ is not rejected

·         Observations are compatible with H₀

·         Observations are due to sampling variation or random errors of measurement

·         Observations are artificial, apparent and not real biological phenomena.

STATISTICAL vs CLINICAL SIGNIFICANCE

·         Statistical significance may have no clinical/practical significance/importance. This is due to other factors being involved but is not studied. It may also be due to invalid measurements.

·         Clinically important differences may not reach statistical significance due to small sample size or due to measurement that are not discriminating enough.

SCIENTIFIC GENERALIZATIONS

·         Science is inductive: several observations lead to a theory

·         Internal validity: each study is done well. External validity: findings can be generalized

·         The aim is internal validity; generalization occurs when many studies concur

·         It takes time for clinical findings to become part of the practice guidelines

·         Malpractice/negligence is deviating from established guidelines resulting in patient harm

·         Boolam case: can deviate from established practice of you follow another one elsewhere

2 ROLES OF RESEARCH

·         Immediate: alive, interested scientific mind eager to get new knowledge and to treat patients according to the most recent knowledge

·         Long term: changes in clinical protocols

TRANSLATIONAL RESEARCH

·         TR bridges the gap between knowledge produced in the lab bench and its use at the bedside and enables society to benefit from its investment in research[1]

·         Transition from physician to researcher and from clinical practice to clinical research[2]

·         Discovery of ovarian cancer biomarkers[3]

·         Stem cell therapy[4]

·         Genetic and molecular basis of pelvic organ prolapse[5]

·         HIV immune activation[6]

·         Animal models of headache[7]

·         Lab clues to treatment of lupus in pregnancy[8]

PHYSICIAN INVESTIGATORS / PHYSICIAN SCIENTIST

·         Physician scientist bridges the gap between the bench and the bedside[9] Physician scientist bridges the gap between basic and clinic[10]

·         we are experiencing a shortage / lack of physician scientists[11] [12]. The vanishing physician scientist[13] Physician scientist attrition[14]. Stimulating interest in physician-investigator career path[15]

·         Physician scientist training programs such as the MD/PhD[16] [17] [18] [19] [20]

·         Biggest hindrance to research is lack of time[21]

REFERENCES

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[1] Health Care Anal. 2012 Dec 18

[2] J Med Pract Manage. 2008 Jul-Aug;24(1):9-12.

[3] Biomark Med. 2012 Oct;6(5):613-25

[4] Clin Transl Sci. 2011 Oct;4(5):380-6.

[5] Int Urogynecol J. 2011 Oct;22(10):1211-9.

[6] AIDS Res Hum Retroviruses. 2011 Apr;27(4):355-64.

[7] Expert Rev Neurother. 2010 Mar;10(3):389-411..

[8] Eur J Clin Invest. 2011 Jun;41(6):672-8..

[9] Curr Opin Endocrinol Diabetes Obes. 2010 Apr;17(2):131-42.

[10] Curr Opin Endocrinol Diabetes Obes. 2010 Apr;17(2):131-42.

[11] Account Res. 2012;19(2):89-113..

[12] Acad Med. 2011 Sep;86(9):1071-2.

[13] Account Res. 2012;19(2):89-113..

[14] Acad Med. 2011 Sep;86(9):1071-2.

[15] J Cancer Educ. 2009;24(3):200-3..

[16] Acad Med. 2009 Apr;84(4):468-71..

[17] Hematology Am Soc Hematol Educ Program. 2008:16-22.

[18] Acad Med. 2008 Oct;83(10):969-75.

[19] J Clin Invest. 2008 Apr;118(4):1233-5.

[20] Acad Med. 2009 Apr;84(4):468-71.

[21] J Formos Med Assoc. 2008 Jul;107(7):519-26..