Clinical case studies and SPSS

1. Writing and reporting clinical case studies:
How and what to compose
AMIT SHARMA
ASSOCIATE PROFESSOR
DEPT. OF PHARMACY PRACTICE
I.S.F. COLLEGE OF PHARMACY
GHAL KALAN, FEROZPUR G.T. ROAD
MOGA, 142001, PUNJAB

2. Things to learn
• Clinical case report /Clinical case study.
• Principles of a case study.
• Structure of CCR and CCS.
• How to write your case study.
• Data collection form.
• Sample size.
• Analytical tools for more effective research.
• Use of software's in developing CCS and CCR.

3. Clinical case study- CCS
 Clinical means - relating to the observation and treatment of actual patients rather than
theoretical.
 The Case is the “real life” situation.
 The Case “Study” is the analysis of this situation.
 A case study is a report about a person, group, or situation that has been studied.
 In medicine, a case study is a detailed report of the symptoms, signs, diagnosis,
treatment, and follow-up of an group of patients suffering from same disease, disorder
or condition.

4. Clinical case study- CCS
 There are two different approaches to case studies
Type 1: The Analytical Approach
The case study is examined in order to try and understand what has happened
and why. It is not necessary to identify problems or suggest solutions.
Type 2: The Problem-Oriented Method
The case study is analysed to identify the major problems that exist and to
suggest solutions to these problems.

5. Clinical case study- CCS
 A successful case study analyses a real life situation where existing problems
need to be solved. It should:
 Identify the problems.
 Select the major problems in the case .
 Suggest solutions to these major problems.
 Recommend the best solution to be implemented.
 Detail how this solution should be implemented.
 The reports of case studies should be in the form thesis, dissertation, project
report and research articles. Therefore, you will need to write in details.

6. Clinical case study- CCS
 A case study convey an educational message through explanation to other
healthcare professionals.
Pharmacist
Clinicians
Nurses

7. Clinical case report- CCR
 In medicine, a case report is a report of the symptoms, signs, diagnosis,
treatment, and follow-up of an individual patient.
 Case report should be only 500 to 1,000 words in length. Therefore, you will need
to write carefully and avoid unnecessarily language.

8. During the preparation phase for writing your case study the following processes
need to be undertaken:
Identify
• Identify the patient and problems associated. (through literature
search)
Message
• Determine the educational message that is to be conveyed in the
case study
Target
• Identify your target audience and therefore your target journal.
(Clinicians, Pharmacist, Nurses, etc.)
How to write your case study

9. Once you have identified your target audience
Journal
• thoroughly read the instructions for authors.
Review
• Review several issues of the journal if you are not familiar with
the usual content.
Checkli
-st
• Check the format, the recommended length of the manuscript
and any other specific guidelines.
How to write your case study

10. Process of writing the case study:
Title Page
•The title page will contain the full title of the article.
Remember that many people may find your article by searching on the
internet.
1. Affiliation: Author’s Name, Designation, Working Place, Contact etc.
2. Abstract: Introduction, Case presentation, Management and Outcome,
Discussion.
3. Key words: Usually 4-5, (e.g. Case study, Case report, Hypertension etc.)

11. Process of writing the case study:
Introduction – (2-3 sentence, History, Discuss objectives of the case)
Case presentation- (Introduce raw data, Describe
complaints, and imp. Information which you have collected) like
abnormal values etc.
Discussion- try to
find out the questions
which can arise in your
studies. Than start writing
discussion, compare your
study with other authors.
Acknowledgment
Management and
Outcome- Define the plan
for care and discuss the care
which is already provided – find
out gap
References

12. Sample size
 Number of parameters in date collection
form X 10= Sample size.
 Epiinfo Statcalc- can be used to calculate
sample size for study.

13. Sample size

14. Data collection form
 Should contain all the information and parameter to be recorded as per study
inclusion criteria.
 Should be evaluated and validated by at least two physicians.
 Define IV and DV in data collection form.
 Give codes to each parameter as per variables i.e. Numerical, Categorical, Ordinal,
Scale.
 INFORMED CONSENT FORM
 ETHICAL APPROVALS – a) IEC- for observation studies.
b) HEC- for therapeutics interventions studies.

15. Data collection form
DRUG UTILIZATION STUDY IN HYPERTENSION AND DIABETES MELLITUS PATIENTS AT TERTIARY CARE HOSPITAL
Name of Patient/Code DOA-
Age :
Weight in kg :
Pulse Rate: /bPm
Blood Pressure: /mmHg
Gender Male Female
Literacy status Illiterate 10th 12th Grad. PG Others
Employment Status Heavy Worker Moderate Worker
Marital status Married Unmarried Widow Divorced
Family history of
DM and HTN
Yes No

16. Data collection form
Duration of
(DM and HTN)
<5yrs
6-10yrs
>10yrs
Diabetes complications:
Hypertensive complications:
Sign / Symptoms Past Medication History(ADR, If any)
Alcoholic/Smoker/Drug Abuse :
Dialysis frequency
Once in a week
> Twice in a week
< Once in 2 weeks

17. Data collection form
Parameter Observed value Normal range
FBS 70-99mg/dl
SGOT 0-35IU/L
SGPT 0-35IU/L
Serum Creatinine 0.7 to 1.3 mg/dL for men
0.6 to 1.1 mg/dL for women
BUN 6 to 20 mg/dL
Hb 12-16 gm/dl (F) 14-18(M) gm/dl
Urine Albumin (24hr) <80 mg
Blood Pressure 120/80mmHg
Hemoglobin A1c - past 3 months > 6.5 (past 3 months average)
Lipid profile
HDL
LDL
VLDL
40 to 60 mg/dL)
190 mg/dL (70 and 189 mg/dL)
2 to 30 mg/dL
Routine Biochemical Investigations

18. Data collection form
Drug Therapy
S. No. Drugs Generic name Category Dose Frequency Remarks

19. Data collection form
Outpatients follow up: Improved/ Not improved
Inpatient: 1) Admitted from emergency ward: OPD
2) Duration of Stay:
3) Recovered / Partially Recovered / Death
4) Remarks at Discharge:
Date of Discharge:
No. of Drugs & Medications Cost:

20. Variables and coding in SPSS
Independent Variables
• An independent variable,
sometimes called
an experimental or predict
or variable
Dependent variables
• Variables:
an outcome variable.
Dependent Variable: Blood Pressure/ body weight/ pulse rate/ other lab values etc.
Independent Variables: Drug A/B/C

21. Variables and coding in SPSS
 THINGS TO KEEP IN MIND WITH SPSS:
 Variable names
Variable names are limited to 8 characters. But you need to make sure that the
8 characters are meaningful enough to eyeball.
(This is important if you import data from Excel and have a header row of
variable names – it will truncate or delete variable names that are too long.)
 File names: Data files are given an “.CSV” extension.

22. Spread sheet in SPSS

23. Coding in SPSS- open SPSS and click on the "variable view"
tab in the bottom left corner of the screen.

24. Coding in SPSS
Name :
• The name of each SPSS variable in a given file must be unique; it must start with a
letter; it may have up to 8 characters (including letters, numbers).
Type
• The two basic types of variables that you will use are numeric and string.
• Numeric variables may only have numbers assigned.
• String variables may contain letters or numbers, but even if a string variable
happens to contain only numbers, numeric operations on that variable will not be
allowed (e.g., finding the mean, variance, standard deviation, etc...)

25. Coding in SPSS
Measurement e.g. km/cm/kg/ time, were Metrix is involved. (0) means nothingScale
• Age
• Income
• Distance
Which are in increasing or decreasing order. e.g.- value/ score. (0) means
something.
Ordinal
• Temp.
Related to some category. Where we give some options to choose something/Nominal/ Categorical
• Region, Gender.
• Zip code
• Religion
Measures

26. Coding in SPSS
Numeric, Date, StringType
• String will be used for both alphabets as well as numbers.
Numbers of character's that can be addedWidth
• 2,3,4 etc.
Description of the variablesLabels
• Age of the respondents.
• Gender of the respondents.

27. Coding in SPSS
Labels that explain the value, numeric is preferred.Value
• Male=1
• Female=2
Optional- if we declare that a value is missing SPSS will omit the value
from analysisMissing
• Missing value will be 9, 99, 999.
Width of the column in data viewColumn
• You can keep 6-8.

28. Analytical tools for more effective research.
Data Collected
Data filled in
SPSS
Ready for
analysis ???
Check
Normality
distribution
Test for
Normal
distribution
Data
Normally distributed
Apply
Parametric
test
Data not normally distributed
apply
Non- Parametric
test

29. Testing for Normality using SPSS-
It will help you to determine whether your data is normal or not.
 Click Analyze > Descriptive Statistics > Explore... on the top

30. Testing for Normality using SPSS
Leave the above options unchanged or Fill
Confidence interval as per your study.

31. Testing for Normality using SPSS
 Click Plot the button. Change the options so that you are presented with the following screen:
Click the Continue button.
Click OK the button.
Output:
SPSS outputs many table and graphs with this procedure.
One of the reasons for this is that the Explore... command is not
used only for the testing of normality but in describing data in
many different ways.

32. Results of Normality using SPSS
 Shapiro-Wilk Test of Normality
• The above table presents the results from two well-known tests of normality.
• Shapiro-Wilk Test is more appropriate for small sample sizes (more than 50 samples) but can
also handle sample sizes as large as 2000.
DVIV

33. Results of Normality using SPSS
 If the Sig. value of the Shapiro-Wilk Test is greater the 0.05 then the data
is normal.
 Other method is Normal Q-Q Plot

34. Other tests for analysis
Normality distribution
Normal
Proceed with
analysis
•Correlation
•Regression
•Paired Samples t-test
•Independent Samples t-test
•ANOVA
Normality distribution
Not Normal
Proceed with analysis
(time bound studies)
Chi Square

35. Other tests for analysis- Correlation
 A correlation and regression tells you how and to what extent two variables are
related.
 We will use this test to find out relation between two variables.
 E.g. Time VS Growth of microganism.
 Time is IV VS Growth of microganism is DV
 SPSS commands- GraphsScatterSimpleDefine.
 (P-value labelled with Sig. on the Output sheet) is below 0.05.

36. References
 MLA Handbook for writers of research papers (7th edition).
 What is MLA?
MLA is a reference tool used in subject areas for the Humanities. It provides
extensive guidelines on how to formulate a topic, format a research paper, cite texts
and compile a list of works cited in English as well as other foreign languages.
 Use a citation when referencing works of others.
 Use- Mendeley or Endnote

37. Avoiding Plagiarism
 When writing a research paper, lab report case study or any other type of
academic assignment. We use other sources for information.
 However, when using someone else’s information, you must indicate
where that information came from.
 If you fail to acknowledge your sources, you are guilty of plagiarism.
 Plagiarism is a serious offence.