GM Assignment July

CRITICAL APPRAISAL INPUTS

~ Rishitha, 3rd Sem

I peer reviewed a research paper on:
“Clinical outcomes in vaccinated individuals hospitalized with Delta variant of SARS-CoV-2”. [Click here]. 

Critical appraisal of scientific literature is a necessary skill for healthcare students. There  are eight critical appraisal tools are designed to be used when reading research. 

CASP has appraisal checklists designed for use with 

1. Systematic Reviews, 
2. Randomised Controlled Trials, 
3. Cohort Studies, 
4. Case Control Studies, 
5. Economic Evaluations, 
6. Diagnostic Studies,
7. Qualitative studies and 
8. Clinical Prediction Rule. 

Critical appraisal is not :

• a negative dismissal of a piece of research 
• assessment of results alone 
• based entirely on details statistical analysis 
• to be undertaken by expert researchers only

SYSTEMIC REVIEW.

1. The results of the review are valid. Because,the review addressed a Clearly focused question. 

This can be explained in terms of -

•  Population studied (total of 1161 SARS-CoV-2 infected patients),
•  the intervention given (patients received treatment as per standard protocols)

• outcome considered (both COVISHIELD and COVAXIN offer protection and have comparable efficacies against the Delta variant)

2.  Cant tell whether the authors looked for the right type of papers. Meaning, I couldn’t critically evaluate their RCT.

3. Its worth continuing Because all the relevant studies were included. Relevant studies cover the bibliography databases that were used, the follow-up from the reference list and personal contact with experts and also unpublished as well as published studies. 

4. Can’t tell whether the author has considered the record of the studies they have identified.

5. It was reasonable to combine the results of the review because the results of all included studies are clearly displayed and the results of different studies are similar and also the reasons for any variations in some results are also discussed.

6. Overall results: Preliminary results indicate that both COVISHIELD and COVAXIN offer protection and have comparable efficacies against the Delta variant resulting in reduction of the disease severity and mortality among the hospitalized patients with two doses of vaccination. Also the results were Numerically appropriate and were expressed in odds ratio.

7. Results can be precise enough if numerically appropriate.

8. The results can help locally. Because the population studied majorly aged >45 years. 

9. All the important outcomes were considered, pointing out at Pfizer-BioNTech vaccine (BNT162b2) and the Oxford-AstraZeneca vaccine (ChAdOx1) outcomes. 

10. Cant tell whether the benefits worth the harm (if any). Because all that matters is to get vaccinated, but its good to know which vaccine would do better.

RANDOMISED CONTROLLED TRIALS.

1. Can’t tell whether the study addressed a clearly focused research question because the study wasn't designed to assist the outcomes of an intervention.

2. The research displays the Progress of patients till the end of the study/protocol. So all participants who entered the study are accounted for at its conclusion.

3. The study wasn't methodologically sound. Because the study groups weren’t divided based on baseline characteristics or weren't there any differences between study groups, and there wasn't any clearly defined study protocol.

4.  Cant tell whether the results would help as such, but can carry great informative value.

COHORT STUDIES

1. The study clearly focused on the issue of clinical outcomes of vaccinated people infected with delta variant of SARS COVID.

2. Cohort was recruited in an acceptable way because everybody was included who should have been and the cohort was a representative for their defined population, elaborating people who took COVISHIELD and not or COVAXIN or not.

3.  The exposure was accurately measured to minimise bias because they they used both subjective (grouping based on vaccine taken)and objective (testing antibody levels and inflammatory markers) methods.

4. Yes, the authors have identified all the important cofounding factors and labelling patients as hypertensive when on antihypertensive drugs, Chronic kidney disease when patients on haemodialysis or eGFR <60 for more than three months and grouped under thromboembolic complications when patient develops thrombotic complications and transient ischemic attack.

5. No, that authors haven’t taken account of the cofounding factors in the design or for analysis because they didn’t deal by matching or restriction methods. 

6. Results of this cohort study can be summarised as within the vaccinated, the neutralising antibody response and total leucocyte counts were higher and serum ferritin levels were significantly lower for those who received COVISHIELD than those who received COVAXIN, however no significant difference was seen in severity or mortality between both the groups. 

7.  Results were precise enough based on the clinical profiles, inflammatory markers and outcomes of vaccinated and unvaccinated COVID positive patients as mentioned in the research.