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Dr KSR Prasad
Dr GD Pol Foundation YMT Ayurvedic Medical College
18th January 2019
SynopsisSynopsis 
• Synopsis is a brief summary or general survey of 
hsomething.
• Each and every organization even though have 
ll i i f ll i ll IMRADsmall variations, follows universally IMRAD
pattern. 
• MUHS offered synopsis format for PG scholars• MUHS offered synopsis format for PG scholars 
needs few areas explanation for well narration.
Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ 1
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
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
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
Research QuestionResearch Question
Primary Research Questiony Q
Secondary Research Question 1
Secondary Research Question 2
I) Population /Patient /Samhita /Books
II) Intervention /Exposure
III) Comparison group
IV) OIV) Outcome
V) Related to primary objective
Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ 5
HypothesisHypothesis
Primary HypothesisPrimary Hypothesis 
Other Hypothesis 1
Other Hypothesis 2Other Hypothesis 2
I) Cl l t t dI) Clearly stated
II) Reflects relation between two or more 
i blvariables
III) Related to primary Research Question
Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ 6
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
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
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
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
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
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
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
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
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
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
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
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
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

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19 01-18 synopsis-best methods

  • 1. Dr KSR Prasad Dr GD Pol Foundation YMT Ayurvedic Medical College 18th January 2019
  • 2. SynopsisSynopsis  • Synopsis is a brief summary or general survey of  hsomething. • Each and every organization even though have  ll i i f ll i ll IMRADsmall variations, follows universally IMRAD pattern.  • MUHS offered synopsis format for PG scholars• MUHS offered synopsis format for PG scholars  needs few areas explanation for well narration. Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ 1
  • 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
  • 6. Research QuestionResearch Question Primary Research Questiony Q Secondary Research Question 1 Secondary Research Question 2 I) Population /Patient /Samhita /Books II) Intervention /Exposure III) Comparison group IV) OIV) Outcome V) Related to primary objective Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ 5
  • 7. HypothesisHypothesis Primary HypothesisPrimary Hypothesis  Other Hypothesis 1 Other Hypothesis 2Other Hypothesis 2 I) Cl l t t dI) Clearly stated II) Reflects relation between two or more  i blvariables III) Related to primary Research Question Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ 6
  • 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