1. Patient centred outcomes research and Clinical research in Individual patients* Introduction to a blended offline-online course BOOC Rakesh Biswas, Professor Medicine, LNMC,Bhopal, Deputy Editor, BMJ Case Reports, UK

2. Patient Centred Outcomes Research: An emerging area since 2010 sourced from :http://www.nejm.org/doi/full/10.1056/NEJMp1207437

3. Helps people and their caregivers communicate and make informed health care decisions, allowing their voices to be heard in assessing the value of health care options. This research answers patient-centered questions such as: Expectations “Given my personal characteristics, conditions and preferences, what should I expect will happen to me?” “What are my options and what are the potential benefits and harms of those options?” “What can I do to improve the outcomes that are most important to me?” “How can clinicians and the care delivery systems help me make the best decisions about my health and healthcare?” OptionsOutcomes Decisions Defining Patient-Centered Outcomes Research (PCOR) 3 PCOR Definition

4. National Priorities for Research and Research Agenda 4 Assessment of Options for Prevention, Diagnosis, and Treatment Comparisons of alternative clinical options to support personalized decision-making and self-care Identifying patient differences in response to therapy Studies of patient preferences for various outcomes Improving Healthcare Systems Improving support of patient self-management Focusing on coordination of care for complex conditions and improving access to care Comparing alternative strategies for workforce deployment Communication & Dissemination Research Understanding and enhancing shared decision-making Alternative strategies for dissemination of evidence Exploring opportunities to improve patient health literacy Addressing Disparities Understanding differences in effectiveness across groups Understanding differences in preferences across groups Reducing disparities through use of findings from PCOR Accelerating PCOR and Methodological Research Improving study designs and analytic methods of PCOR Building and improving clinical data networks Methods for training researchers, patients to participate in PCOR Establishing methodology for the study of rare diseases....

5. PCORI Board Member Harlan Krumholz, MD National Patient and Stakeholder Dialogue National Press Club, Washington, DC February 27,2012 “ This is going to be research done differently!”

6. Research Classification and where does all this fit in? Qualitative Research Naturalistic study designs Case Study CS research method MIXED Quantitative Research Empirical or interventional study design Randomized Controlled trials RCTs METHODS?

7. Limitations of RCT Clinical trial data Clinical trialsClinical practice Number of PatientsHundreds(rarely thousands)Thousands to millions DurationWeeksYears PopulationPregnant, children and elderly excluded All Concomitant medication and illness AvoidedUsually present DoseFixedVariable ConditionsRigorous More information Flexible: Less information

9. Two different research paradigms? Population based Very structured Explanatory Highly transferable, explicitly Does not retain context. Generalizable i e Easily applicable to generic problems Patient centred Less structured Exploratory and explanatory Transferable in both implicit and explicit form. Retains context. Individualizable: i e Well applicable to specific problem instances BMC Medical Informatics and Decision Making 2004, 4:19 http://www.biomedcentral.com/1472-6947/4/19

10. A Different Methodology for Patient Centred Research?

11. Introduction to an IMRAD abstract for Patient centred Research Introductory Assumptions: Every patient is a separate research project and deserves special attention. It begins with a patient encounter but may not necessarily end solely with that patient. It can fit into an IMRAD structure in spite of these assumptions.

12. IMRAD Abstract template for Patient centred Research? Introduction: For all our projects our broad research questions are: What ails this patient and how can we help find better options? Method: An informational intervention can help answer the above questions? A platform that thrives on online-offline multidisciplinary inputs? Results: Answers to what ails and what options does the patient have and what new innovations were developed through multidisciplinary inputs. Discussion: How does it fit in with what other researchers have found in similar patients? What are the perspectives for future research (especially testing new innovations )?

13. Our patient centred research intervention: Utilizing Multidisciplinary inputs to the Patient Centred Online Health Record PCOHR to drive patient care

14. We don’t need to set up a clinical trial We don’t need to enrol a single research subject Source: http://www.nytimes.com/2013/01/15/health/mining-electronic-records-for-revealing-health- data.html?pagewanted=all&_r=0http://www.nytimes.com/2013/01/15/health/mining-electronic-records-for-revealing-health- data.html?pagewanted=all&_r=0 Mining Patient Data from PCOHRs

15. Data mining : tools and techniques Descriptive models Identifies similar patterns Uses: Classification, Association rules and Visualization. Predictive models Identifies current impact from past data Uses: Classification, Regression and Time series analysis Sourced from https://fedcsis.org/proceedings/2011/pliks/142.pdf

16. The data of current case experiences are compared to similar solutions that were successful in past cases Past solutions are the starting point for solving the new case Useful for including co-occurrence of multiple diseases, time series features and overlapping diagnostic categories Sourced from https://fedcsis.org/proceedings/2011/pliks/142.pdf Data mining : The Case Based Reasoning technique

17. The Case Based Reasoning cycle Sourced from: http://www.idi.ntnu.no/~agnar/publications/esrel98.pdf

18. Data mining u sing Case Based Reasoning: A Case Study

19. Patient Centred Research: An Illustration

23. Another patient with enlarging hands and Feet uploaded to our PCOHR intervention

24. Patient Centred Inter Institutional Collaboration

25. What is the diagnosis and what are his best options toward cure?

26. Potential workflow for LN Medical College Patient centred case study research:

28. Results? Did we answer the most important research question for this patient? What ails this patient and how can I help find better options?

29. Who else in interested in Patient centred research?

31. Patient Centred Inter Institutional Collaboration

34. Join us BMJ Case Reports Medical Elective: http://promotions.bmj.com/jnl/bmj-case-reports-student-electives/ Phd program in Health Informatics in collaboration with Monash University, Malaysia: https://sites.google.com/site/niknailah/Home/call-for-phd- candidate-scholarship

35. More here July 2014, French student experience: http://userdrivenhealthcare.blogspot.in/2014/09/positive- role-of-medical-electives-in.html Feb 2015, US and Indian student experience: http://userdrivenhealthcare.blogspot.in/2015/02/medical- elective-learning-points-from.html October 2013 Bhopal student feedback:http://likethechickenscratch.blogspot.in/?m=1, July 2014 CMC Vellore presentation on Bhopal Medical Elective:https://www.youtube.com/watch?v=Xm2LpqAmqjo