Friday, August 5, 2022

Thesis draft "Clinical complexity in Diabetes: Qualitative evaluation of patients, interventions and outcomes."

Problem statement/Background:


Among patients with diabetes, clinical complexity and treatment burden have increased over time." (1)

"Piette and Kerr created a framework dividing multiple chronic conditions into three categories: (a) concordant (illnesses which share similar pathogenesis and management as diabetes such as cardiovascular disease), (b) discordant (where the illness is unrelated, yet whose management may be at odds with diabetes care, such as musculoskeletal disease or mental illness), and (c) dominant illnesses, whose severity overshadows diabetes care (such as end-stage renal failure or metastatic cancer)."(2) 


"The ADA/AGS consensus breaks diabetes treatment goals into three strata based on the following patient characteristics: for patients with few co-existing chronic illnesses and good physical and cognitive functional status, they suggest a target A1c of under 7.5%, given their longer remaining life expectancy. Patients with multiple chronic conditions, two or more functional deficits in activities of daily living (ADLs), and/or mild cognitive impairment may be targeted to 8% or lower given their treatment burden, increased vulnerability to adverse effects from hypoglycemia, and intermediate life expectancy. Finally, a complex patient with poor health, greater than two deficits in ADLs, and dementia or other dominant illness, would be allowed a target A1c of 8.5% or lower." (3)



AIM: 

To navigate clinical complexity in patients with diabetes and optimize their management toward reducing diagnostic and therapeutic uncertainty along with improvement in their anemia outcomes. 

OBJECTIVES:

• To assess various clinical and investigational characteristics of patients with diabetes in relation to their clinical complexity and outcomes.

• To analyse patient outcomes based on morbidity (physical, social & psychological limitations)


PATIENTS AND METHODS:

PLACE OF STUDY: Department of General medicine 

STUDY PERIOD: November 2022- October 2024

STUDY DESIGN : Non experimental (Observational) qualitative Study 

SAMPLE SIZE: 50 patients 

Methodology.and objectives :

To be detailed after going through the sample cases linked below (and more). 

INCLUSION CRITERIA:

• Complex Diabetes patients of any gender above or equal to 18yrs of age at the time of presentation.

Complex needs of the Diabetic patients would be assessed using the COmplex NEeds Case-finding Tool – 6 (CONECT-6), which evaluates the following variables: low perceived health; limitations due to pain; unmet needs; high self-perceived complexity; low income; and poor social support. With a threshold of two or more positive answers, the sensitivity was 90% and specificity 66%. The positive and negative predictive values were 49 and 95% respectively. (4)




EXCLUSION CRITERIA:

1.Patients below 18 yrs of age (minors)

2.Patients not capable of giving consent (mentally-ill patients)

3.Patients not willing to participate in study (non-consenting patients) kp

4. Non complex diabetes 


PROFORMA (data to be captured) 


Demographics

Patient event data reflected in a narrative history of the  sequence of events leading to the current presentation and outcomes

Body data from clinical general and systemic examination 

Pallor 

Lymphadenpathy 

Nails 

Organomegaly 

Skin 

Muscle mass 

Mid arm circumference 

Visceral fat 

Body data from laboratory investigation :

  • CBP with peripheral smear 
  • Iron profile with serum ferritin 
  • Serum albumin 
  • Serum creatinine
  • Special tests on indication :
  • Thyroid function tests 
  • Chest X-ray -PA view
  • ECG
  • 2D ECHO
  • Bone marrow if indicated 
Data from treatment instituted :

Data from Patient reported outcomes :

Daily functionality (in terms of routine activities)

Daily diet in the form of meal images captured before consumption 

Daily intake output where relevant such as complex anemias with renal failure and nutritional deficiency or anemia and chronic diarrhoea 

Sample diabetes with Clinical complexities case report forms linked below :



https://tejasridevaruppala36.blogspot.com/2022/08/diabetic-foot-ulcer-with-ckd.html?m=1 (complex diabetes, problems yet to be listed and resolved) 


(complex diabetes with renal pain and failure) 



https://didyalasushmitha37.blogspot.com/2022/07/dm-2.html?m=1(complex uncontrolled diabetes with alcoholism) 

Clinical complexity consists of a few defining characteristics such as uncertainty, non linearity, unpredictability and yet an overall pattern leading to resolution through attractor states over time. (5) As physician attractors we are uniquely privileged to "be" with our patients regardless of the diagnosis and that is the only way we may know our patient's outcomes where our "being" with them is the most significant (and often overlooked) intervention. 


Sample MASTER CHART WITH LINKS TO PATIENTS E-LOGs

Link To Master Chart:

https://drive.google.com/file/d/1qEvnrKR8DNYWp4TMdwPmMeORyFTWkcYT/view?usp=drivesdk


PATIENT INFORMATION SHEET

English:

https://drive.google.com/file/d/12LLDgFBVfnTxDdNv5K715uSyLYPUEgrY/view?usp=drivesdk

Telugu:

https://drive.google.com/file/d/13Df9wCu9zhjECpPxcHEULSAphv6-tDHl/view?usp=drivesdk


Template of this "patient information sheet" is borrowed from this website:

https://www.ncbi.nlm.nih.gov/books/NBK261334/

And modified accordingly to my thesis topic.

References :

1) Benning TJ, Heien HC, McCoy RG. Evolution of Clinical Complexity, Treatment Burden, Health Care Use, and Diabetes-Related Outcomes Among Commercial and Medicare Advantage Plan Beneficiaries With Diabetes in the U.S., 2006-2018. Diabetes Care. 2022 Aug 4:dc212623. https://pubmed.ncbi.nlm.nih.gov/35926104/

2) Piette JD, Kerr EA. The impact of comorbid chronic conditions on diabetes care. Diabetes Care. 2006;29(3):725–31.

3)Hackel JM: Patient-centered care for complex patients with type 2 diabetes mellitus—analysis of two casesClin Med Insights Endocrinol Diabetes 2013;6:47–61

4)Hudon, C., Bisson, M., Dubois, MF. et al. CONECT-6: a case-finding tool to identify patients with complex health needs. BMC Health Serv Res 21, 157 (2021).


5) Plsek PE, Greenhalgh T. Complexity science: the challenge of complexity in health care. BMJ. 2001 Sep 15;323(7313):625–8. doi: 10.1136/bmj.323.7313.625.




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