This document discusses utilizing patient care data from clinical settings for clinical research purposes. It describes the types of data available, common barriers faced, and the need to obtain proper permissions. A variety of research study designs are possible using this data, including descriptive studies, interventional studies, qualitative research, and quality improvement projects. Case studies, case series, surveys and collaboration are recommended approaches. Addressing barriers like permissions and developing research skills can help facilitate use of this valuable data source.

1. Utilisation of patient care
data in clinical research
Prof Dr. Smriti Arora
Principal, CENER, AIIMS Rishikesh
For National Institute of Tuberculosis and Respiratory
Diseases(NITRD), NEW Delhi
1.09.2023

2. What is Clinical research ?
• Clinical research is a branch of healthcare science that
determines the safety and effectiveness of
• medications
• devices - thermometers
• diagnostic product/tests - X ray , Blood test, sputum test
• treatment regimens intended for human use.
• It may be used for prevention, treatment, diagnosis or for
relieving symptoms of a disease

3. Patient care data available in clinical
settings
• Registers, files
• Online records

4. Barriers
• Delayed Institutional Permissions
• Permissions from patients
• Confidentiality of data
• Lack of knowledge about methodology, protocols
• Data is not correct
• Missing data

5. Do we need permission to use data ?
• Yes
• Institutional Ethics committee - approval is must
• Follow institutional protocols

6. What types of research
can be done ?
• Descriptive-
case control
study, case
study,
• Interventional-
experimental,
QI

9. • PRISMA - Preferred
Reporting Items for
Systematic Reviews and
Meta-Analyses.
• It is an evidence-based
minimum set of items
for reporting in
systematic reviews and
meta-analyses.

12. Where to use case study approach ?
• Describe in detail a patient's episode of care
• Explore professional attitudes
• Understand experiences of a new policy initiative or service development
• Identifying an unexpected association between diseases or symptoms.
• An unexpected event in the course of observing or treating a patient.
• Report findings that shed new light on the possible pathogenesis of a disease or
an adverse effect. Eg thalidomide and birth defects/ Unique or rare features of a
disease /Unique therapeutic approaches.

13. Which clinical questions does Case Study / Case
Report / Case Series best answer?
• Emerging conditions, adverse reactions to treatments,
atypical / abnormal behaviour, new programs or methods of
treatment – all of these can be answered with case studies
/case reports / case series.
• They are generally descriptive studies based on qualitative
data e.g. observations, interviews, questionnaires, diaries,
personal notes or clinical notes.

14. • A case report is a detailed report of the
diagnosis, treatment, response to
treatment, and follow-up after treatment
of an individual patient.
• A case series is group of case reports
involving patients who were given similar
treatment.

15. Single case study vs multiple case study
Single case study Multiple case study
• If a researcher wants to study a specific
phenomenon arising from a particular
entity, then a single-case study is
warranted.
• It allows for a in-depth understanding of
the single phenomenon and, would
involve collecting several different types
of data.
• Using a multiple-case research study
allows for a more in-depth
understanding of the cases as a unit,
through comparison of similarities and
differences of the individual cases
embedded within the quintain.
• Evidence arising from multiple-case
studies is often stronger and more
reliable than from single-case research.
• Multiple-case studies allow for more
comprehensive exploration of research
questions and theory development.

16. How are case studies conducted?
• Familiarize yourself with the case study type, style as well as the
design
1. Selecting the case
• Case should illustrate an important point regarding case
management- examination, evaluation, intervention or outcome.

17. How are case studies conducted?
2. Collecting data
• Choose the right candidate, inclusion criteria
• Observation – participant observation
• Records, diaries, Logbooks , field notes, charts
• Interview- structured, semi structured, open ended questions . You must have a
proper interview questions list to ensure you are not going to miss even a single
query.
• Case studies of individual patients often involve in-depth interviews with
participants and key informants, review of the medical records, observation,
and excerpts from patients' personal writings and diaries.
• Steps taken to address the problem
• Describe intervention ( when, by whom, duration, protocol followed ?)

18. How are case studies conducted?
3. Analyzing and interpreting the data
•Results: anything unique or significant
•Challenges you faced and how you overcome them
•Lessons learnt
4. Reporting the findings

19. How to report case studies ?
• Good case reporting demands a clear focus, to make explicit to
the audience why a particular observation is important in the
context of existing knowledge.
• The CARE guidelines (for CAse REports) were developed by an
international group of experts to support an increase in the
accuracy, transparency, and usefulness of case reports.

20. 2013 CARE Checklist
1.Title – The diagnosis or intervention of primary focus followed
by the words “case report”.
2.Key Words – 2 to 5 key words that identify diagnoses or
interventions in this case report (including "case report").
3.Abstract – (structured or unstructured)
1.Introduction – What is unique about this case and what does it add to
the scientific literature?
2.The patient’s main concerns and important clinical findings.
3.The primary diagnoses, interventions, and outcomes.
4.Conclusion – What are one or more “take-away” lessons from this case
report?

21. 4. Introduction – Briefly summarizes why this case is unique
and may include medical literature references.
5. Patient Information
1.De-identified patient specific information.
2.Primary concerns and symptoms of the patient.
3.Medical, family, and psychosocial history including relevant
genetic information.
4.Relevant past interventions and their outcomes.
6. Clinical Findings – Describe significant physical
examination (PE) and important clinical findings.

22. 7. Timeline – Historical and current information from this episode
of care organized as a timeline (figure or table).
8. Diagnostic Assessment
1.Diagnostic methods (PE, laboratory testing, imaging, surveys).
2.Diagnostic challenges.
3.Diagnosis (including other diagnoses considered).
4.Prognostic characteristics when applicable.
9. Therapeutic Intervention
1.Types of therapeutic intervention (pharmacologic, surgical, preventive).
2.Administration of therapeutic intervention (dosage, strength, duration).
3.Changes in therapeutic interventions with explanations.

23. 10. Follow-up and Outcomes
1.Clinician- and patient-assessed outcomes if available.
2.Important follow-up diagnostic and other test results.
3.Intervention adherence and tolerability. (How was this assessed?)
4.Adverse and unanticipated events.
11. Discussion
1.Strengths and limitations in your approach to this case.
2.Discussion of the relevant medical literature.
3.The rationale for your conclusions.
4.The primary “take-away” lessons from this case report (without
references) in a one paragraph conclusion.

24. 13. Patient Perspective – The patient should share their
perspective on the treatment(s) they received.
14. Informed Consent – The patient should give informed
consent. (Provide if requested.)

25. Examples
1. Intraoperative Rupture of an Intracranial, Extradural Hydatid
Cyst: Case Report and Treatment Options
• https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8699760/
2. Case Study: Transition to a Vegan Diet in an Elite Male Gaelic
Football Player
• https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7824752/
3. Extensive deep vein thrombosis following prolonged gaming
(‘gamer’s thrombosis’): a case report
• https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3851187/

26. Limitation of case studies
• Can't always be generalised to the broader population
• Difficult to replicate
• Lacks rigor , not systematic in data collection
• Allows bias in findings, may include researcher bias

27. Methodological study
Tool development
• Develop and psychometrically test the COVID-19 prevention,
detection, and home-management self-efficacy scale (COVID-19-SES)
to assess people’s self-efficacy in preventing, detecting symptoms,
and home-managing COVID-19.
• Psychometric Evaluation of Nurses’ Intention to Care Scale (P-NICS)
for Patients with HIV

28. Diagnostic study
➢Nasal swab
➢Throat swab
➢Lower respiratory tract aspirate
➢Saliva/stool sample
➢Physical symptoms
➢CT Scan
• PPEs, masks, sanitizers and
novel disinfecting systems

29. QI studies
• Step 1- Identify a problem, Formulate a team,
Aim
• Step 2- Analyse the problem
• Process flow chart, fish bone
• Develop indicators
• Step 3- Develop and test Changes, PDSA –
Plan Do Study Act
• Step 4- Sustain the improvement

31. QI topics
• Virtual clinics vs face to face OPD consultations
Processes Outcomes
Handwashing
Standard precautions –
mask, PPE
Donning doffing
BMW mx
Prevalence of Infection
Increased absenteeism
Stress
Burnout

32. Qualitative studies
• Experiences of people with Cancer
• Experiences of caregivers- stress and burn out
• Experiences of health care personnels – staff nurses/doctors/paramedics
• Stress – PPE, Infection, salary, job, ethics
• Nursing perspectives on care delivery during the early stages of the covid-19
pandemic: A qualitative study
• The Lived Experience of Nurses Caring for Patients with COVID-19: A
Phenomenological Study
• Data collection method- In-depth exploration, collect data through telephone

33. Collaboration is a good idea
• Interdepartmental collaborations- Nutrition, physiotherapy,
biostatistics etc.
• State or National collaborations
• International collaborations with foreign institures/universities

34. Overcoming barriers
• Good professional relationship with all members of heath team
• The research must be of benefit to patients and institute
• Good networking within and outside departments
• Find a mentor/guide/expert
• Build a team
• Start with small projects first, show results and then take up
challenging projects
• Look out for funding agencies

35. Funding opportunities
• Dept of Science and Technology
• UGC- major / minor research projects
• ICMR
• UCOAST
• DAAD (Indo-German)
• All India Council for Technical Education (AICTE)
• Council of Scientific and Industrial Research (CSIR)
• Grants from corporates for social projects
• Federation of Indian Chambers of Commerce and Industry (FICCI/CII)
• INC, TNAI
• ICSSR, USAID, UNICEF

36. Preparing a proposal for funding
• Objectives – SMART
• Prepare according to guidelines
• Benefit to society
• Budget justified
• Credibility of PI

37. Summary
Reuse of health care data directly for research purposes has the
potential to bring significant value and accelerate learning in several
key areas:
• streamlining clinical research processes at health institutions
• improving data quality by reducing the number of transcription errors
• evaluating the feasibility of research protocols and the availability of
patients to participate in research
• providing real world evidence
• enhancing drug safety and early identification of safety events.

38. THANK YOU

39. References
• https://ebn.bmj.com/content/21/1/7
• https://static1.squarespace.com/static/5db7b349364ff063a6c58ab8/
t/5db7bf175f869e5812fd4293/1572323098501/CARE-checklist-
English-2013.pdf
• https://www.care-statement.org/
• https://deakin.libguides.com/quantitative-study-designs/casestudy