Sunday, January 21, 2024

Thesis protocol : Clinical Profile, Comorbidities and Outcomes in patients with Cardiac Arrhythmias

Title


Clinical Profile, Comorbidities and Outcomes in patients with Cardiac Arrhythmias

Problem statement :

The impact of a given arrhythmia in a given situation depends on the patient’s cardiac physiology and function. 

Similarly, urgency and type of treatment are determined by the physiological impact of the arrhythmia as well as by underlying cardiac status.(ref) 

All the above "events" suggesting diagnostic and therapeutic urgency and uncertainty are dependent on "patient event factors" that influence the comorbidities in patients with cardiac arrhythmias and there are very few studies that have addressed this in the past (ref) and our study aims to bridge this gap.



Aim

To Learn About  Factors Influencing Clinical Profile and Comorbidities in the Development of Cardiac Arrhythmias and It's outcomes and correlating team  learning outcomes with patient improvement outcomes 

Objectives :


1) To collect and document arrhythmia patient illness event data reflecting their morbidities and comorbidities in their individual historical timeline.

2)To match collected individual particular patient event data with past  generalizable data around cardiac arrhythmias 

3)To evaluate each thematic category of arrhythmia patient event data into diagnostically labeled morbidities as well as comorbidities and establish a relation between their intervention outcomes over time

4) To synthesise new learning outcomes over what is currently available and documented globally for patients with cardiac arrhythmia and establish the relationship, if any, between the newly synthesized learning outcomes from each cardiac arrhythmia patient participant and their or their subsequent patient's healing outcomes.


MATERIALS AND METHODS :

STUDY DESIGN :

Qualitative, Prospective and Observational study that evaluates each thematic category of patient illness event data into diagnostically labeled morbidities as well as comorbidities and establishes a relation between their intervention outcomes over time

METHODOLOGY : 

Patients having irregular pulse and irregularities in ECG are selected from CASUALTY, OPD, IPD  in ... Institute of Medical Sciences

Consent is taken for study participantion as well as deidentified data sharing from the patient and their advocates/relatives after explaining the potential harms and benefits along with need for further follow up. 

Sample informed Consent forms:

1) For deidentified case reporting 


2) Patient information sheet :

English:


Telugu:



Template of this "patient information sheet" is borrowed from👇


And modified according to the thesis topic.

CONSENT FORMS




Sample case report form to demonstrate thesis objectives:



For thesis "Clinical Profile, Comorbidities and Outcomes in patients with Cardiac Arrhythmias"




Please see this sample case report form/proforma (collected and suitably archived albeit semistructured case data):




Demonstration of thematic analysis and objectively structured clinical evaluation(OSCE) data extraction process from the above single case report proforma in line with the objectives below :



1) To collect and document arrhythmia patient illness event data reflecting their morbidities and comorbidities in their individual historical timeline.


Morbidities : Cough, SOB (COPD ac ex)  since 5 days


Comorbidities :


CAD  since 2 yrs not using any medication since 2 months 


Heart failure current admission 


Years of Significant Alcohol intake, stopped 7 months back. 


Years of significant Smoking stopped 1 year back.


Interventions :


For arrhythmia : Inj adenosine 6mg iv stat followed by 

Inj Adenosine 6mg iv stat 

 Tab digoxin 0.5 mg stat followed by 0.25 mg 


For COPD : Neb with ipravent 6 th hrly , budecort 12 th hrly, Tab pulmoclear BD 

Inj Monocef 1 gm IV BD 


For CAD : Tab ecospirin  AV 75/10 po hs 


For CCF : Inj Lasix 20 mg IV TID if bp is less than 110 mmhg.


2)To match collected individual particular patient event data with past  generalizable data around cardiac arrhythmias and associated comorbidities and their outcomes 


The above patient data was matched to past available data around similar clinical scenarios with similar arrhythmias and comorbidities and following learning themes emerged that needed to be pursued further:


Diagnostic uncertainties:


COPD and it's associated arrhythmias due to particular structural involvements in the pulmonary hypertensive right heart or simply due to metabolic and blood gas factors (data absent in this sample case report proforma).  


CAD CCF and associated arrhythmias due to particular structural involvements in the left heart (this patient had significant left heart structural involvement in chambers, contractility and valve function but Echo data was incomplete due to it's not reporting the right ventricular parameters).


Therapeutic uncertainties :


Absence of afterload reducing agents for his left heart failure management 


Role of indiscriminate antibiotics in  absence of microbiological drivers 


 Role of CAD prophylactic agents and their stopping in indirectly precipitating the current outcomes of arrhythmias 


 Role of mucolytics and mucokinetics in COPD acute exacerbations 



3)To evaluate each thematic category of arrhythmia patient event data into diagnostically labeled morbidities as well as comorbidities and establish a relation between their intervention outcomes over time


The patient timeline that is usually displayed daywise in a single fever chart along with soap notes is currently missing from the above sample case report proforma and hence this third objective is not met at this point of time  


4) To synthesise new learning outcomes over what is currently available and documented globally for patients with cardiac arrhythmia and establish the relationship, if any, between the newly synthesized learning outcomes from each cardiac arrhythmia patient participant and their or their subsequent patient's healing outcomes.


From the above diagnostic and therapeutic uncertainty themes extracted from the single sample case report form and on review of literature of existing knowledge around these, it's clear that  more research using similar clinically complex patient data is needed to synthesize information over what is currently available. In this given individual patient the cardiac arrhythmia appears to have multiple influences, namely the blood gas changes from COPD and or heart failure as well as due to structural changes due to CAD and his outcomes needs to be gathered meticulously over time using currently available "medical cognition" tools. 



No comments:

Post a Comment