This document contains a list of 13 group members and their student IDs. It then provides a proposed question based on a clinical scenario using the PICO framework. The question is about a 60-year-old female diagnosed with peripheral arterial disease and type 2 diabetes. The document concludes with a critical appraisal of a study based on the Critical Appraisal tool, answering 12 questions about the study methodology, results, and applicability.

1. Group 9

2. Group 9
 Puveraj Gunasekaran 130110132026
 Nor Adira Eliany Binti Alias 130110113053
 Michelle Ann Sheridan Daniel 130110132017
 Visalakshi Ramanathan 130110132042
 Muhammad Ikhlas Abdian Putra 130110130126
 Raka Ghufran Wibowo 130110130170
 Ahsani Rahma Rudibianti 130110130073
 Muhammad Nuur Fauzi 130110130049
 Renita Dewi Supiyana 130110130115
 Amalia Ahsani 130110130061
 Evi Anugrah Arumningsih 130110130074
 Fatimah Amalia 130110130140
 Nabila Nauli Asriputri 130110130155
 Jasmine Maulinda Utami 130110130195

3. Answerable question based on the scenario
above according to PICO scheme.
 Patient or problem : 60-year old female
newly diagnosed with peripheral arterial
disease
 Intervention : type 2 diabetes
 Comparison : -
 Outcome : peripheral arterial disease.

4. Critical Appraisal based on Tool
Kit
1. Did the study address a clearly
focused issue?
 Yes, The population studied were clearly
described and the risk factors were also
mentioned. Besides that, the outcomes
were considered in two ways where there
was a primary outcome and a secondary
outcome. It’s clear that the study tried to
detect a beneficial effect.

5. Critical Appraisal based on Tool
Kit
2. Did the authors use an appropriate method to
answer their question?
 Is a cohort study a good way of answering the
question under the circumstances? Yes
 Did it address the study question? We have
addressed these gaps in knowledge by establishing
a large prospective cohort using linked electronic
health records,8,9 which combine information about
diabetes diagnosis, risk factors, and medication use
with future cardiovascular events. Our objective was
to investigate and compare associations between
type 2 diabetes and future risk of 12 of the most
common initial cardiovascular presentations in men
and women.

6. Critical Appraisal based on Tool
Kit
3. Were the cohort recruited in an acceptable way?
 No, because not all subjects are classified into expose
group using the same procedure this study used
multivariable cox regression they also used multiple
imputation to account missing covariate data

7. Critical Appraisal based on Tool
Kit
4. Was the exposure accurately measured to minimize bias?
Yes
HINT: We are looking for measurement or classification bias:
- Did they use subjective or objective measurements?
Objective. We defined individuals as having diabetes at
baseline (type 1, type 2, or uncertain type) on the basis of
coded diagnoses recorded in CPRD or hospital episode
statistics at or before study entry (appendix).
- Do the measures truly reflect what you want them to (have
they been validated)? : Cant tell.
- Were all the subjects classified into exposure groups using
the same procedure? : Yes
We defined individuals as having diabetes at baseline (type
1, type 2, or uncertain type) on the basis of coded diagnoses
recorded in CPRD or hospital episode statistics at or before
study entry (appendix).

8. Critical Appraisal based on Tool
Kit5. Was the outcome accurately measured to minimize bias?
 Yes
- Did they use subjective or objective measurements? objective
measurement
- Do the measures truly reflect what you want them to (have they been
validated)? they have been validated
- Has a reliable system been established for detecting all the cases
(for measuring disease occurrence)? reliable system has been
established for detecting all the case
- Were the measurement methods similar in the different groups?
measurement were similar in different group
- Were the subjects and/or the outcome assessor blinded to exposure
(does this matter)? no blinded to exposure

9. Critical Appraisal based on Tool
Kit
6. A. Have the authors identified all important confounding factors?
Yes
List the ones you think might be important, that the authors missed.
B. Have they taken account of the confounding factors in the design
and/or analysis? Yes
 Modeling :
Social deprivation was included in models as quintiles of the index of
multiple deprivation, a score calculated for each participant’s
neighbourhood on the basis of social indices such as income, education,
and employment
 Stratified :
Data recorded before study entry were used to classify participants as
never smokers, ex-smokers, or current smokers at baseline. The baseline
hazard function of each model was stratifi ed by general practice and sex,
and we used multiple imputation to account for missing covariate data
(appendix). We also did analyses adjusted for age and sex only, and
analyses adjusted for age, sex, and cardiovascular risk factors. We
assessed interactions with age and sex.

10. Critical Appraisal based on Tool
Kit
 Regression :
We used multivariable Cox regression to calculate cause-
specific hazards for associations between type 2 diabetes
and initial presentations of cardiovascular disease.
 Sensitivity :
We did a sensitivity analysis comparing individuals with any
diabetes diagnosis to those without diabetes (most patients
with diabetes in a cohort of this age would have type 2
diabetes). We did sensitivity analyses ignoring endpoints
recorded only in primary care (CPRD), restricted to fatal
endpoints, or restricted to individuals who entered the study
after 2004. We did analyses using R 2.15. This trial is
registered with ClinicalTrials.gov, number NCT01804439.

11. Critical Appraisal based on Tool
Kit
7. A. Was the follow up of subjects
complete enough? Yes
B. Was the follow up of subjects long
enough? Yes
Because the long of the interval is 5,5
years

12. Critical Appraisal based on Tool
Kit
8. What are the results of this study?
-This study includes 1921260 individuals whereby
1887062 did not have diabetes and 34198 had DM Type
2.
-There were 113638 cardiovascular events over
11.6million person-years of follow up.
-6137 were DM Type 2 individuals, where 992 individual
with peripheral arterial disease and 866 individual with
heart failure was the first presentation.
-107501 were individual without DM Type 2, where 10074
with peripheral arterial disease and 13072 individual with
heart failure was the first presentation.

13. Critical Appraisal based on Tool
Kit
-For individual aged 40 years without cardiovascular disease,
risk of getting CD by 80years old :-
-No other statistically significant differences between sexes.
-In DM Type2 individual, risk of cardiovascular disease was
highest for those with HbA1c concentration of 58 mmol/mol or
higher.
-Individual with DM Type2 and HbA1c concentration less than
48mmol/mol had an increased risk of peripheral arterial disease
and ischaemic stroke, but no greater risk of any of the other 12
cardiovascular diseases.

14. Critical Appraisal based on Tool
Kit
9. How precise are the results?
 How precise is the estimate of the risk?
By looking at the value of confidence interval
HINT:
- Size of the confidence intervals
The prevalence of any type of diabetes in all
individuals in CALIBER aged 40–50 years (with
or without previous cardiovascular disease) was
1·52% (95% CI 1·47–1·57) in women and 2·25%
(2·19–2·32) in men (appendix).

15. Critical Appraisal based on Tool
Kit
10. Do you believe the results?
 HINT:
-Big effect is hard to ignore! (???)
-Can it be due to bias, chance or confounding? No
-Are the design and methods of this study sufficiently flawed to make the
results unreliable? No. This study used records from the CALIBER
programme, which links data for people in England recorded in four
electronic health data sources. They define individuals as having diabetes
using CPRD record and also check the HbA measurements for diabetic
patients. And also they use cumulative incidence curves for comparing the
initial presentation of cardiovascular disease and used Cox models to
estimate cause-specific hazard ratios. And overall, the result were robust to
a range of modifications explored in sensitivity analyses, which is type 2
diabetes was strongly associated with composite cardiovascular mortality
and all-cause mortality.
-Consider Bradford-Hills criteria!

16. Critical Appraisal based on Tool
Kit
 11. Can the results be applied to the local population? YES
 HINT:
consider whether:
1. the subjects covered in the study could be sufficiently different
from your population to cause concern
2. your local setting is likely to differ much from that of the study
3. can you quantify local benefit and harm?
benefit: because this research take subjects from wide range of
population in UK, obviously it can represent local population there.
so, the benefit for local people are they can prevent cardiovascular
disease if they have DM type 2
harm: wide range of cardiovascular disease that might occur could
confusing us, it could lead us to wrong preventive action with
harmful effect.

17. Critical Appraisal based on Tool
Kit
 12. Do the results of this study fit
with other available evidence? Yes

18. Thank You