Assignment EPIDEMIOLOGY

Prognostic Research
Medical programme, year 2
Block 2.5 – Thinking and Doing 2 Brains moving further on

Scenario and Perspective: CVA – patient.

Tutorial group nr:

We hereby declare that:

- all group members have significantly contributed to the realization of the paper
belonging to the assignment “Prognostic research”

Number of group members: 4 Date: Wednesday, April 29, 2020

Name of student: Name of Student: Name of Student:

Sagda kamal Bushra Mohandes Enas Bassam Taha

Student number: Student number: Student number:

181210136
181210121 171210008

Signature Signature Signature

Name of student: Name of Student: Name of Student:

Leena Yousif Mohamed Ibrahim

Student number: Student number: Student number:

181210135

Signature Signature Signature

 Assessment (P, S, G)

Assessment form
Assignment Prognostic Research (Epidemiology)
Block 2.5: Thinking and Doing II

Student Name / ID 1: Leena Yousif Mohamed Ibrahim / 181210135

Student Name / ID 2: Enas Bassam Taha / 171210008
Student Name / ID 3: Bushra Mohandes / 181210121
Student Name / ID 4: Sagda Kamal / 181210136

Scenario: Cerebral Vascular Accident

Perspective: Patient

PAPER
1. Research question - - / - / +- / + / ++
2. Setting (incl. perspective) - - / - / +- / + / ++
3. Study design (incl. motivation for choice) - - / - / +- / + / ++
4. In- and exclusion criteria - - / - / +- / + / ++
5. Moment in course of disease - - / - / +- / + / ++
6. Outcome(s) (primary/secondary) - - / - / +- / + / ++
7. Measurement instrument(s) (incl. motivation) - - / - / +- / + / ++
8. Follow-Up (duration / frequency) - - / - / +- / + / ++
9. Strategies for preventing loss-to-follow-up - - / - / +- / + / ++
10. Prognostic factors - - / - / +- / + / ++
11. Flowchart / scheme - - / - / +- / + / ++
12. Literature references - - / - / +- / + / ++

13. Structure (logical?) - - / - / +- / + / ++

14. Creativity/originality - - / - / +- / + / ++
15. Argumentation (incl. presentation) - - / - / +- / + / ++
16. Appearance (lay-out, phrasing, etc.) - - / - / +- / + / ++

SUGGESTIONS FOR IMPROVEMENT

INTRODUCTION
Prognostic research is essential to allow doctors to predict the general outline of
illnesses and decide treatments. Also, it informs patients about the future course of their
illness. In this research on patients with CVA, the study design is determined. Then, the
criteria of patients are precisely chosen, optimizing the external and internal validity of
the study. Also, it measures all outcomes with relative prognostic factors taken into
consideration, and follow-up volunteers over intervals of time with proper measures to
prevent loss-to follow-up and thereby improve the accuracy.
RESEARCH QUESTION
What is the 5-year risk of progression of CVA in patients of 65 years and older, who
were diagnosed with stroke for the first time by a neurologist, starting from the time of
diagnosis?

SETTING
Worldwide, 17.9 million people die annually from CVA. The incidence is approximately
40.000 per year, and prevalence in 2007 was 200.000.
The incidence in people aged 65 or older is 14/1000 annually. In Saudi Arabia, the
prevalence of CVA was estimated 43.8/100.000/year.
We chose King Khalid University Hospital, the Neurology Unit in it is the largest in the
kingdom with 24-hour emergency service. We will evaluate patients admitted with
diagnosis of a first-time-stroke and above age 65.

STUDY DESIGN
Prognosis describes the probability of an outcome. The standard prognostic design is a
longitudinal observational prospective cohort study in which a group of people with a
particular condition are followed over a period of time.
Motivation of design choice:
• Cohort study provides the best information about causation and risk factors of
diseases. Also, you can examine a range of outcomes. And with data from the
cohort studies, you can calculate the cumulative incidences which are the most
direct measurements of the risk of a developing disease
• Patients must be followed up for long enough so that most outcomes have
occurred
 • Cohort study would typically follow up one or more groups of individuals with the
disease but have not yet suffered an adverse event, and monitor the number of
outcome events over time..

CRITERIA
Inclusion and exclusion criteria together determine who is eligible to participate in the
study. This is important to prevent loss-to-follow-up and we do these criteria at the time
of diagnosis.
Inclusion Criteria:
• Age of 65 and above:
Stroke occurs at any age, but the risk of having a stroke doubles each decade
after the age of 55.
• Both sexes:
The incidence of stroke is higher in men until advanced age. Then, a higher
incidence of stroke is seen in women after age 85 years.
• Diagnosed with stroke for the first time:
In about half of patients who survive from stroke, there is increased risk of having
another stroke after 2 years.

Exclusion Criteria:
• Age below of 65:
Stroke can occur below age of 65. In 2009, 34% of people hospitalized for stroke
were younger than 65 years.
• Patients with prior stroke:
They have higher risk for stroke recurrence and are not related to age or
pathological stroke. Also, Patients with prior incidence have higher risk of
mortality.
• Patients with transient ischemic attack (TIA):
TIA patients are at higher risk for recurrent stroke within a few days.
OUTCOMES:
Primary outcome:
The main result is recovery, observed through follow-up and physical examinations
(i.e., normal reflexes). The patient is expected to have complete, partial, or no recovery.
The primary outcome measurements assess the patients’ overall health after the
accident.
Secondary outcomes:
Firstly, cranial bleeding; diagnosed by CT/MRI where lesions appear hyper-dense on
contrast, and the scale is dichotomous.
Moreover, stroke victims may die, which are reported in civil registrations with a
dichotomous scale. Also, sensorimotor defects are detected through physical
examination and scaled as none, mild, moderate, or severe.
Also, speech problems are detected by physical practitioner interviews, in which
assessment includes having pronunciation problems (Broca’s aphasia), interpretation
problems (Wernicke’s aphasia), both (global aphasia), or none.
Furthermore, swallowing disorders are observed in swallow studies, in which
assessment is on a scale of normal, solid foods, soft foods, liquids, or none.
A related outcome to swallowing is enduring limitations in which patients’ daily activities
(i.e., working) are affected. Measured through interviews carried by social workers.
Then, patients receive a score of none, mild, moderate, or severe.
Not only that, but also cognition disorders are diagnosed through MMSE, in which
normal is (25-30), mild (21-24), moderate (10-20), and severe (<10).
Besides, depression may be observed by the family members; here, the investigation is
through the DSM-5 criteria, with a dichotomous scale.
Lastly, both behavioral and emotional changes are observed in follow-ups; the order is
dichotomous as well.
All of the previous outcomes are regarding the Doctor’s perspective.
*dichotomous: yes/no

PATIENT/FAMILY PERSPECTIVE
The patient’s quality of life, as well as their employment, may be significantly affected by
accident; because of chronic disability.
The family will be emotionally affected as the patient experiences changes in character,
or financially affected in case the survivor was the breadwinner.
FOLLOW-UP:
Patients are followed up prospectively in 1 month, 6 months, 12 months, 3 years, and 5
years. During every follow-up, tests must be performed, including physical examination,
neurological assessment, and radiological screening (CT/MRI).
A 5-year period is suitable to collect sufficient data and analyze it accurately. From the
patients’ aspect, a 5-year period is possible if they are compliant. The frequency of
follow up helps specify the stage of progression in each patient.

PROGNOSTIC FACTORS:
A prognostic factor is any characteristic of a prospective patient that determines the
outcome of a disease. It classifies into several sub-groups: Disease-specific features are
the most pertinent; elevated cholesterol levels and increased blood pressure comprise
the most adverse prognostic factors for progression of CVA, as well as presenting with a
late stage of the disease. Demographic factors, including female gender or black race,
are fixed elements to individual patients and result in higher susceptibility. Social factors,
such as low social support / low income, do not play a significant role in the prognosis.

LOSS-TO-FOLLOW-UP
Prevent the loss-to-follow-up by collecting information that enhances tracking subjects,
e.g., address, telephone number, and email, for the cases and their contacts such as
friends, family members, or neighbors. Maintain regular contact via personal information.
Send participants newsletter intermittently to keep them updated on how the study
progresses. Subjects may disappear due to death, relocation, or loss of interest.
 Study Question
What is the 5-year risk of progression of CVA in patients of 65
years and older, who were diagnosed with stroke for the first
time by a neurologist, starting from the time of diagnosis?

Inclusion and Exclusion criteria

Study Population and Setting •Inclusion Criteria :
•Patients that admitted to King Khalid •Age of 65 and above.
University Hospital in Ryadh with clinical •Both sexes, Women and men.
diagnosis of first ever stroke with 65 yrears •Diagnosed with stroke for the first
old. time.
•Exclusion Criteria :
•Age below of 65.
•Patients with prior stroke.
•Patients with transient ischemic
attack.

Outcome
•Primary outcome: Recovery
Study Design
•Measurement instrument follow-up+physical • longitudinal observation prospective
examinations cohort study.
•Scale: Complete/partial/none • Cohort study provide the best
•SECONDARY OUTCOMES information about causation and risk
• cranial bleeding factors of a particular disease.
•Measurement instrument: CT/MRI • Follow patients with long period to
•Scale; dichotomous (yes/no) define the prognosis properly.
• Death • Most Cohort studies are ethically safe
•Measurement instrument: civil registrations because you can follow up one or more
(death registers) groups to define prognostic factors.
•Scale: dichotomous (yes/no)

Prognostic Factor
•Demographic factors
Follow-up
• increased age •1 month, 6 months, 12 months, 3 years,
•gender (female) and 5 years to do the essential tests and
•race (black) determine the stage of progression of
•Disease-specific the disease
•elevated cholesterol levels
•high blood pressure
•Social factors
•low income
•low social support
REFERENCES
[1] Moons, K., Royston, P., Vergouwe, Y., Grobbee, D., & Altman, D. (2009). Prognosis
and prognostic research: what, why, and how?. BMJ, 338(feb23 1), b375-b375. doi:
10.1136/bmj.b375

[2] Who.int. 2020. Cardiovascular Diseases. [online] Available at: https://www.who.int/health-

topics/cardiovascular-diseases/#tab=tab_1

[3] The Analysis Factor. 2020. Cohort And Case-Control Studies: Pro's And Con's - The Analysis
Factor. [online] Available at: https://www.theanalysisfactor.com/cohort-and-case-control-studies-
pros-and-cons/

[4] Health Knowledge. 2020. Studies Of Disease Prognosis. [online] Available at:
https://www.healthknowledge.org.uk/public-health-textbook/research-methods/1a-
epidemiology/sudies-disease-prognosis

[5] Medicalnewstoday.com. 2020. Cohort Study: Finding Causes, Examples, And Limitations.
[online] Available at: https://www.medicalnewstoday.com/articles/281703

[6] Burn, J., Dennis, M., Bamford, J., Sandercock, P., Wade, D. and Warlow, C., 1994. Long-term
risk of recurrent stroke after a first-ever stroke. The Oxfordshire Community Stroke Project.
Stroke, 25(2), pp.333-337.

[7] Appelros, P., Stegmayr, B. and Terént, A., 2009. Sex Differences in Stroke Epidemiology.
Stroke, 40(4), pp.1082-1090.

[8] Oza, R., Rundell, K. and Garcellano, M., 2020. Recurrent Ischemic Stroke: Strategies For
Prevention. [online] Aafp.org. Available at: https://www.aafp.org/afp/2017/1001/p436.html

[9] Mental State Examination, Dr. Amal. Block 2.5 April 2020.

[10] Riley, R., Moons, K., Hayden, J., Sauerbrei, W., & Altman, D. (2020). Prognostic factor
research. from https://oxfordmedicine.com/view/10.1093/med/9780198796619.001.0001/med-
9780198796619-chapter-7

[11] Mohammadbeigi, A., Faraji, F., Ghasami, K., & Talaie-Zanjani, A. (2013). Prognostic factors
in acute stroke, regarding to stroke severity by Canadian Neurological Stroke Scale: A hospital-
based study. Asian Journal Of Neurosurgery, 8(2), 78. doi: 10.4103/1793-5482.116378

[12] (COVID-19), C., Health, E., Disease, H., Disease, L., Management, P., & Conditions, S. et al.
(2020). How a Stroke Is Diagnosed and Treated. From
https://www.webmd.com/stroke/guide/understanding-stroke-treatment#1