3. Type of study
• Qualitative ‐ community’s perception involves data collection tools
• Quantitative
Type of study
Quantitative
– Descriptive ‐ drug standardization methodologies
– Analytical ‐ Hypothesis tested with comparison
– Experimental – Clinical intervention
– Diagnostic Accuracy Studies‐ Disease diagnostic study
• Literary Study• Literary Study
– Conceptual study /Fundamental study
– Manuscriptology
• Animal Experiments ‐ for Toxicity, dose regulation etc
• Mixed methods ‐ quantitative & qualitative using Lab and Patients
d l tand evaluate
•
Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ 2
4. TitleTitle
• I) Clear & briefI) Clear & brief
• II) Patient / Participant / Samhita / Books
) fl S d d i• III) Reflects Study design
• IV) Reflects primary objectives
– Appropriateness.
– Justification of the topic.
Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ 3
5. IntroductionIntroduction
• Justifies the Rationale of the studyJustifies the Rationale of the study
– Purpose of study.
Mention of lacunae in current knowledge– Mention of lacunae in current knowledge.
– Hypothesis, if any.
Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ 4
8. Review of LiteratureReview of Literature
I) Clearly statedI) Clearly stated
II) Reflects relation between two or more
variablesvariables
III) Related to primary Research Question
– Relevance.
– Completeness.
– Is it current and up‐to‐date?
– Citation of reference is properly done or not?
Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ 7
9. Review of LiteratureReview of Literature
XII) Additional points for Research in AYUSH) p
a. Reference of drug / procedure
b. Reference of disease
D /F l ti d t ilc. Drug/Formulation details
d. Treatment details
1 Included recent /ongoing research relevant to1. Included recent /ongoing research relevant to
present study
2. Presents knowledge gap for the stated problem
3. Minimum 15 references to be placed in concern
section
Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ 8
10. ObjectivesObjectives
Primary Objectives
Other objectives 1 & 2Other objectives 1 & 2
In SMART criteria?
• Specific – target a specific area for improvement.
• Measurable – quantify or at least suggest an indicator of
progress.progress.
• Achievable – Whether the investigator can achieve with the
available resources.
• Realistic state what results can realistically be achieved• Realistic – state what results can realistically be achieved,
given available resources.
• Time‐related – specify when the result(s) can be achieved
Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ 9
11. MethodologyMethodology
I) Appropriate study design) pp op ate study des g
– Type of Trial: Observational / Interventional
– Type of Study:Cross sectional/ Follow up study/
Cohart Study / Case control study / Other (Specify)
– Study design: Single arm / Non Randomized Placebo
control / Non Randomized Active controlled / Noncontrol / Non Randomized Active controlled / Non
Randomized multiple arm /Randomized parallel
Placebo control/ Randomized parallel Active control /
R d i d ll l M lti l / d i dRandomized parallel Multiple arm/ randomized
crossover / Cluster randomized / Randomized factorial
/ Other Trial (Specify)
Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ 10
12. MethodologyMethodology
II) Mentioned study setting (Intervention / Comparator Agent)
– Type: Intervention / Comparator
– Inclusion Age / Gender / Details
– Exclusion Details
Methods Adaptive randomization (minimization)/Coin toss– Methods Adaptive randomization (minimization)/Coin toss,
lottery, toss of tide, shuffling cards/computer generated
randomization/ permuted block randomization(Fixed)/
permuted block randomization(Variable)/ random number
tables / stratified block randomization/ stratified
– Blinding/Masking: Double blind double dummy / investigator– Blinding/Masking: Double blind double dummy / investigator
blinded/ open label/ outcome assessor blinded/ participant
and investigator blinded/ participant and outcome assessor
bl d d/ bl d d/blinded/participant blinded/ participant, investigator, outcome
and date‐entry operator blinded/ not applicable
Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ 11
13. Sample sizeSample size
III) Mentioned Study population / Books – population of the
areaarea
IV) Sample size
a. Correctly calculated sample size for the primary objectivea. Correctly calculated sample size for the primary objective
based on previous study
b. Adequate for primary objective
c. If not adequate, acceptable justification provided
V) Appropriate sampling technique
Statistical methods employed, level of significance
considered and sampling technique applied
Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ 12
14. Method of selectionMethod of selection
VI) Method of selection of study subjects.
• a Appropriate Inclusion criteria Ages & Gender• a. Appropriate Inclusion criteria – Ages & Gender,
condition (ICD‐10 criteria), conditionings, etc
• b. Appropriate Exclusion Criteria – Ages & Gender, pp p g ,
specify the conditions,
• c. Appropriate Subject withdrawal Criteria – define
VII) Operational definitions provided / Coining of terms –
especially used Sanskrit terms
VIII) Appropriate Methods of measurements Details ofVIII) Appropriate Methods of measurements ‐ Details of
materials (for e.g., apparatus used, laboratory tests,
etc,)
Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ 13
15. DataData
IX) Appropriate Study instrument / Data Collection
tools – Parameters (Subjective / Objective) ( j / j )
X) Methods of Data Collection relevant to objective
Questionnaire
CCases
Records
Field study
XI) Appropriate data Analysis plan and methods –
statistical methods applied – t test, anova, chi
square etcsquare, etc
Statement of limitations.
Mention of ethical issues involved if anyMention of ethical issues involved if any
Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ 14
16. AdditionalAdditional
XIII) Additional points for RCTXIII) Additional points for RCT
• a. Randomization proposed
b ll i l ( i )• b. Allocation concealment (Prevention)
proposed
• c. Blinding proposed
XIV) Additional points for all Experimental) p p
Studies
• a Explained intervention in required detailsa. Explained intervention in required details
Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ 15
17. Reference StyleReference Style
VANCOUVER style BIBLIOGRAPHIC REFERENCES
• Book:Book:
– Neal MJ. Medical pharmacology at a glance. Oxford: Blackwell Scientific;
1987.
Ri i MK B d D G l d l d hi kill f 2 d– Rinsgiven MK, Bond D. Gerontology and leadership skills for nurses. 2nd
ed. Albany (NY): Delmar Publishers; 1996.
• Journal article
– You CH, Lee KY, Chey YW, Menguy R. Electrogastrographic study of patients
with unexplained nausea, bloating and vomiting. Gastroenterology
1980;79:311‐4. ;
– Vega KJ, Pina I, Krevsky B. Heart transplantation is associated with an
increased risk for pancreatobiliary disease. Ann Intern Med 1996 Jun 1;124
(11):980‐3. ( )
Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ 16
18. Reference StyleReference Style
VANCOUVER style BIBLIOGRAPHIC REFERENCES
C t Fil• Computer File
– Hemodynamics III: the ups and downs of hemodynamics
[computer program] Version 2 2 Orlando (FL): Computerized[computer program]. Version 2.2. Orlando (FL): Computerized
Educational Systems; 1993.
• Website (Including the access date)( g )
– Michael Dick, THE ANCIENT AYURVEDIC WRITINGS,
https://www.ayurveda.com/resources/articles/the‐ancient‐
/ayurvedic‐writings, 1/1 frames, dated 1‐1‐2019 at 10.38PM
Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ 17
19. AnnexureAnnexure
Annexures (should not reveal any identity):‐Annexures (should not reveal any identity):
• I) Case Record Form / Questionnaire /
Proforma / any other study instrument to beProforma / any other study instrument to be
used in study.
II) I f d C f (I l di i i• II) Informed Consent form (Including version in
vernacular language)
• III) Timeline/Gantt Chart
Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ 18
20. Last minute
• Don’t forget to add –
Last minute
– Letter of proper channel
– Report of ethics committee
– Concluding remarks by assessor and subject
expert.
Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ 0