THE PROFILE OF STROKE

 

THE PROFILE OF STROKE IN JOS UNIVERSITY TEACHING HOSPITAL (JUTH), JOS

 

DR OSAIGBOVO GODWIN OSAWARU

DEPARTMENT OF INTERNAL MEDICINE,

JOS UNIVERSITY TEACHING HOSPITAL,

JOS

                                                    

ABSTRACT

Cerebrovascular disease (majorly stroke) is the third leading cause of death worldwide. Stroke mortality has been shown to be higher in blacks in multiracial studies; it is also a very important cause of disability with its attendant deterioration in the quality of life in survivors

Objectives; To determine the risk factors associated with stroke, assess the case fatality rate 3 months post stroke, determine the bad prognostic factors and assess the sensitivity and specificity of clinical subtyping of stroke using the WHO and Siriraj stroke scoring system.

Method

A comparative cross sectional study that will be carried out at Jos University teaching Hospital over a period of two years. Stroke patients admitted into the neurology unit within the period will be assessed.

Demographic data will be recorded, subjects examined and investigated. Risk factors will be assessed as well as deaths and the factors associated with death. Clinical subtyping of stroke will be done using the WHO and Siriraj stroke score, these will be correlated with neuroimaging findings. A further assessment of the survivors will be carried out with the modified Rankin scale and Barthel index at 3months post stroke.

A Control population who meets the inclusion and matching criteria will also be made, the controls subjects will be matched for age and sex on a one on one basis

Data will be analyzed with the statistical package for social sciences version 20 (SPSS inc.), frequency tables will be generated for the variables of interest. Means and standard deviation will be determined. Means will be compared using analysis of variance while categorical variables will be compared using chi square test. A multivariate logistic regression analysis will be done to determine the independent predictors of stroke. A p value of < 0.05 will be taken as a measure of statistical significance.

 

BREAKDOWN OF BUDGET FOR THE STUDY

1. Laboratory Tests/ CT Brain scan – 1,669,400 NAIRA
2. Data Collection / Analysis – 60,000 NAIRA
3. Personnel  – 60,000 NAIRA
4. Total – 1,789,400

 

BREAKDOWN OF THE BUDGET FOR THE TESTS

 

Serial No.	Item/Test	Unit Cost (Naira)	Quantity	Total Cost (Naira)
1	Fasting Plasma Lipid	1300	492	639,600
2	Fasting Plasma Glucose	400	492	196,800
3	Electrocardiography	500	492	246,000
	Consumables
4	SST	2000	8	16,000
5	Cryovast	20	1000	20,000
6	Pastuer pipette	20	700	14,000
7	Vacutainer needles	20	1000	20,000
8	Gloves	1000	8 packs	8,000
9	Cotton wool	1500	2 packs	3000
10	Spirit	1500	2bottles	3000
11	5mls Syringe	1500	2 packs	3000
12	CT Brain scan	25000	20	500,000
Total				1,669,400

 

BUDGET JUSTIFICATION

1.  Data collection and analysis

• Printing of Questionnaire
• Data analysis

2. Personnel

• Doctors – would be involved in educating participants, administering the questionnaire, and examination of patients
• Radiologist- who will carry out the CT-Scans and report the findings
• Nurses – would be involved in educating participants and taking anthropometric measurements
• Statistician – data analysis

3. Laboratory Physician – Will carry out the specialized biochemical tests.

 

PROJECT NARRATIVE

This award will help fund the documentation of the profile of stroke in a Nigerian hospital setting.

Data from this initial study will help source for funding for future research work that will focus on the prevalence of repeat stroke with the aim of identifying those at risk of repeat stroke, so interventions including prevention, timely treatment and control of risk factors can be addressed aggressively.

 

RESEARCH PLAN

GENERAL AIM

To determine the profile of stroke in Jos University Teaching Hospital, Jos

SPECIFIC AIMS

1. To determine independent risk factors of stroke
2. Determine the significant predictors to stroke
3. Assess the specificity, sensitivity and accuracy of clinical subtyping of stroke using Siriraj stroke score and WHO staging system with CT Brain scan as gold standard
4. Assess the case fatality rate at 3 months post stroke

 

BACKGROUND AND SIGNIFICANCE

According to the latest WHO statistics,^1,2 cerebrovascular disease (majorly stroke) is responsible for 10.8% of total deaths and 3.1% of the burden of disease worldwide. Age-adjusted stroke mortality rates and disability-adjusted life-years loss rates are higher in low-income countries.³  With the epidemiologic transition in many developing countries, increased prevalence of risk factors for stroke are anticipated, including hypertension, tobacco use, obesity, unhealthy diets, physical inactivity, and diabetes. A recent systematic review of worldwide stroke incidence showed that stroke incidence has declined by 42% in high-income countries over the 4 decades from 1970–1979 to 2000–2008.⁴ During the same period, stroke incidence rose more than 100% in low- to middle-income countries, these statistics further compound the problems caused by HIV/AIDS, malaria and tuberculosis and other infectious diseases in these regions.

In Nigeria, the projected cumulative gross domestic product (GDP) loss due to stroke, heart disease, and diabetes from 2006–15 is $1.17 billion.⁵ The estimated mortality from stroke in Nigeria for the year 2005 was 126 per 100 000.⁶ Data from hospital-based studies show that stroke is responsible for 45% of neurological admission and 5–17% of neurological death with a 30-day case fatality rate of between 28% to 40%.⁶ The dominant modifiable risk factor for stroke in Nigeria is systemic hypertension which is present in almost all cases with a great majority of the victims not knowing their blood pressure status before having a stroke. Diabetes mellitus is another important risk factor among Nigerians and is present in up to 11% of cases.⁶ With HIV/AIDS pandemic, increasing numbers of apparently cryptogenic cases of stroke are being discovered in HIV positive patients.⁶  Dyslipidimia is another risk factor and the prevalence of dyslipidermia has also increasesd in recent years as revealed in a study on healthy workers in Nigeria that showed that 5% of the population had hypercholesterolemia, 23% had elevated total cholesterol, 51% had elevated LDL AND 60% had low HDL with females having better profiles⁷. Obesity and lifestyle factors such as poor diet, sedentary lifestyle and smoking contribute to the increasing rates of stroke in Africa. In a meta-analysis among West African populations, the prevalence of obesity was 10.0%.⁸  Obesity is also a predominant risk factor for women compared to men, but smoking is mostly a risk factor for men.⁷

The management of stroke patients involves timely presentation, emergency room care, neuro-intensive care and stroke unit management. The sub acute phase management is mainly supportive and takes place in the stroke care ward and physiotherapy unit. The chronic phase takes place in the community and outpatient clinic.⁹ Thrombolytic therapy which is the main stay in the management of ischemic stroke cannot be instituted until a diagnosis of an ischemic stroke is made. The hitherto non availability of CT scan in most hospitals in this country hampered the institution of immediate and appropriate treatment of stroke patients but despite the availability of neuroimaging in recent years in most tertiary health centres stroke patients present late to such facilities and are thus not candidates for thrombolytic therapy where available. Mortality in stroke is still high, most especially in haemorrhagic stroke. A study done in Benin reported acute phase mortality of 66.78% and a 3 months mortality rate of 79%.¹⁰ A lot of factors have been studied as predictive factors for mortality in stroke patients. These factors include neurological state of the patients at the time of admission, (using the Glasgow coma Scale), the volume of haematoma, cerebral edema, and the presence of intra ventricular or sub arachnoids extension. Rehabilitation therapy is the corner stone in the management of stroke patients. Stroke disability is devastating to the patient and the family. In rehabilitating a stroke patient, physical therapy, occupational therapy, speech and language therapy are instituted. Many stroke patients require psychological or psychiatric help after a stroke because psychological problems such as depression, anxiety, frustration and anger are common post stroke disabilities.^11-18

There has been very few studies on this subject matter in the past and the few studies done were in the era of the dearth of neuroimaging facilities in a resource limited setting like ours and no study has been done in the North Central zone of Nigeria to test the sensitivity and specificity of tools for the clinical subtyping of stroke. In view of this, this study  aims to  provide baseline data on stroke in this environment as well as to determine the risk factors associated with stroke, assess the case fatality rate 3 months post stroke and assess the sensitivity and specificity of clinical subtyping of stroke using the WHO and Siriraj stroke scoring systems.

 

EXPERIMENTAL DESIGN AND METHODS 

This is a comparative cross sectional study of the profile of stroke in JUTH with a 3  month follow up phase among stroke patients . All the patients will be assessed shortly after admission.

SAMPLE SIZE DETERMINATION

The sample size was determined by the formula for cross-sectional study

 

                 n =             Z² pq

                                    ∂²     

Where:

n = the desired sample size

Z = the standard normal deviation corresponding to 95% level of confidence. The value obtained from a standard normal distribution is 1.96.

p = the prevalence of hypertension (the commonest modifiable risk factor for stroke) in a previous study in the middle belt of Nigeria was 82.4%.¹⁹ so a p value of 0.8 is used

q = 1 – p (1 - 0.8) = 0.2

∂ = degree of accuracy desired is set at 5% (0.05)

The sample size,          n      =         (1.96)² x 0.8 x 0.2

                                                                   (0.05)²      

n =  246  per group (246 stroke patients and 246 control)

 

SAMPLING METHOD

All consecutive patients with stroke who satisfy the inclusion criteria will be included in the study. These patients will be admitted through the accident and emergency units, MOPD and referrals from other departments until the sample size is met.

The controls will be recruited from the general out-patient clinic and other patients who present in the hospital for conditions unrelated to stroke as well as patients’ care givers. They will be recruited weekly from the list of all matched eligible controls for age and sex using simple random sampling technique by balloting until the sample size is met. 

 

SUBJECTS

These will be patients with a diagnosis of stroke. The diagnosis will be made clinically. The ‘WHO criteria’ and the Siriraj stroke score will be used to subtype the stroke. All patients, will have a brain CT scan done to confirm the diagnosis.

 Inclusion Criteria

1. All patients aged > 18 years with a diagnosis of stroke.
2. Patients who gives an informed consent or consent obtained from a valid surrogate in case of unconscious patients and those with speech difficulties

 Exclusion Criteria

1. All patients with prior neurological disease and consequent neurologic deficit.
2. All patients with transient ischemic attacks.
3. All patients with head trauma.
4. All patients who refuse to give consent.
5. All patients who present one week or more after the stroke.

 

CONTROLS

These will be hospital based controls with no clinical evidence of stroke or TIA. The controls will be matched for age (±3yrs) and sex on a ratio of one for one.

 

INCLUSION CRITERIA

1. No clinical evidence of stroke

 

EXCLUSION CRITERIA

1. A Previous history of stroke
2. Current admission for ischemic heart disease or myocardial infarction
3. Unable to provide consent.

 

 

STUDY PROTOCOL

All consecutive patients who satisfy the inclusion criteria and gives consent will be recruited into the study and those not willing to participate in the study will be excluded. A predesigned anonymous questionnaire will be completed by each participant during the interview. This interviewer administered questionnaire consist of different sections namely; socio-demographic data, time of presentation after a stroke, past history of hypertension and diabetes mellitus and whether on treatment or not and compliance on medication. Assessment by WHO and Siriraj staging will be used to stratify the stroke subtype. A general examination, cardiovascular and neurological examination is then carried out and a baseline NIHSS assessment will be done to prognosticate the outcome of stroke, and further assessment of the survivors will be carried out with the modified Rankin scale and Barthel index assessment at 3months after the stroke. A pilot study will be conducted with 20 participants and ambiguous items will be modified accordingly. A CT scan of the brain will be done on all patients who can afford it and some fund from this grant will be used to procure a brain CT scan for at least 20 indigent subjects who will not be able to afford neuroimaging based on socio-economic class of the subjects and their care givers as well as well as provide fund for other ancillary investigations

Ethical approval will be obtained from the ethical committee of the hospital. An informed consent will be obtained from the patients and where not possible, from a responsible care giver and controls. Anonymity and confidentiality of the information obtained from the participants in this study will be assured and maintained.

STATISTICAL ANALYSIS

Data will be processed and analyzed with the statistical package for social sciences version 20 (SPSS inc.). Frequency tables will be generated for qualitative variables such as sex, age group, ethnicity and other characteristics of the study subjects. Means and standard deviation will be determined for age, Fasting blood sugar e.t.c. Unpaired students t-test will be used to determine the difference in means of variables such as FBS, age, systolic BP, BMI, waist hip ratio between the stroke patients and the controls. Analysis of variance will be used to determine variation of variables between and within the two groups. Chi square test will also be used to establish relationship characteristics of the stroke patients and the fatality as well as in comparing the risk factors for stroke in both groups.  Scores will be generated from both the Siriraj and WHO staging system tool. Positive Predictive Value (PPV), Negative Predictive Value (NPV), Sensitivity, Specificity and overall accuracy of the Siriraj assessment tool and the WHO staging system tool will be calculated using Brain CT scan as reference tool (Gold Standard). Kappa ratio will be used to determine the level of agreement of the stroke diagnostic tools.  Multivariate logistic regression analysis will be done to determine the independent predictors of stroke. A 95% confidence interval will be used in this study with a  p value of < 0.05 considered statistically significant.

 

REFFERENCES

1. World Health Organization. Mortality estimates by cause, age, and sex for the  year 2008. Geneva: WHO. Available at: www.who.int/healthinfo/global_burden_disease/en/. Accessed October 7, 2011.
2. World Health Organization. The global burden of disease—2004 update. Geneva: WHO; 2008.
3. Johnston SC, Mendis S, Mathers CD. Global variation in stroke burden and mortality: estimates from monitoring, surveillance, and modelling. Lancet Neurol 2009; 8: 345– 354. 
4. Barker-Collo SL,   Feigin V, Lawes CMM,  Parag V,  Bennett DA.  Worldwide stroke incidence and early case fatality reported in 56 population-based studies: a systematic review. Lancet Neurol 2009; 8: 355– 369. 
5. Abegunde DO, Mathers CD, Adam T, Ortegon M, Strong K. The burden and costs of chronic diseases in low-income and middle-income countries. Lancet 2007; 370: 1929–38.
6. Wahab KW. The burden of stroke in Nigeria. Int J Stroke 2008; 3: 290–2.
7. BeLue R, Okoror TA, Iwelunmor J, Taylor KD, Degboe AN, Agyemang C et al. An overview of cardiovascular risk factor burden in Sub-Saharan African countries: a socio-cultural perspective. Global Health 2009; 5: 10.
8. Abubakari AR, Lauder W, Agyemang C, Jones M, Kirk A, Bhopal RS. Prevalence and time trends in obesity among adult West African populations: a meta-analysis. Obes Rev. 2008 Jul;9(4):297-311.
9. Oyejide C O. Health Research Methods for Developing Country Scientists. ISBN 978-195-044-2 pp 59-63.
10. Adeyekun AA, Ogunrin AO, Irabor PF. Computed tomography predictors of mortality in haemorrhogic stroke. Tropical Journal of Health Science, 2007; 14(20):13-18.
11. Njoku CH, Aduloju AB. Stroke in Sokoto, Nigeria. A five years retrospective study. Ann African med,
12. 2004; 3: 73-6.
13. Odusote K. Management of stroke Nigeria med pract, 1996; 32:56-62.
14. Onwuchewa A, Bellgam H, Asekomeh G. Stoke at the University of Port Harcourt teaching hospital,
15. River state, Nigeria. Trop Doc, 2009; 39:150-2.
16. Al Rejeh S, Awada A, Niazi G, Larbi E. Stroke in a Saudi Arabian National Guard Community: Analysis of 500 consecutive cases from a population Based Hospital. Stroke, 1993;24; 1635-9.
17. Osuntokwu BO. Stroke in Africans. Afr J med Sci, 1997;6:39-55
18. Walker R. Hypertension and stroke in sub-Saharan African. Trans R Soc trop med Hyg, 1994;85: 609-11.
19. Sanya EO, Desalu OO, Adepoju F, Aderibigbe SA, Shittu A, Olaosebikan O. Prevalence of stroke in three semi-urban communities in the middle belt region of Nigeria: a door to door survey. The pan African Medical Journal, 2015;20:33.

 

 

QUESTIONNAIRE ON STROKE STUDY IN JUTH

1. DEMOGRAPHIC CHARACTERISTICS

1.  Serial No
2.   Initials
3.  Phone number of next of kin:
4.  Address:
5.  Hospital No:
6.  Date of admission.
7.  Sex:                      Male                Female
8.  Age in years:………………

9     Religion    (a) Christianity             (b) Islam          (c) Others

         10   Occupational           (a) Civil Servant          (b) Self Employed      

    (c) Pensioner          (d) None

        11   Educational Status (a) Primary      (b) Secondary (c) Tertiary (d) Informal  (e) None

    12   Married Status       (a) Single         (b) Married      (c) Widowed   

   (d) Divorced (e) Separated

13. Time Lapsed before Presentaion

 

14. Cigarette (Pack year)

          15 Alcohol consumption (Units/week)

 

CLINICAL HISTORY

WHO CRITIERIA

FEATURES	YES	NO
Loss of Consciousness
Vomiting
Transient
Gradual Onset
Activity
High Blood Pressure
Headaches

 

FROM WHO STAGING  [] Ischeamic          [] haemorhagic

SIRIRAJ STROKE SCORE

2.5(LOC) + 2(Vomiting) +2( headache) + 0.1(DBP) – 3(Atheroma factors) -12

SCORE=

PAST MEDICAL HISTORY 

HTN     [] Yes              [] No   

Duration of diagnosis of HTN

on Drugs?  [] Yes                    [] No

Compliance. Grade from 1 to 10       

D.M

Duration of diagnosis of DM

On Drugs?  [] Yes                   [] No

Compliance Grade from 1 to 10        

Last FPG before stroke in mmol/L

How long ago was your last FPL done?

Previous stroke [] Yes             [] No   

SCD                   [] Yes                        [] No   

Cardiac Disease     [] Yes                   [] No   

 

EXAMINATION

1. GENERAL

a waist circumference

b hip circumference

c waist hip ratio

d BMI

 

2. CARDIOVASCULAR  EXAMINATION

            (a)Admission Blood Pressure

3         NEUROLOGICAL EXAMINATION

a.        Glasgow coma score

c.         Cranial nerve deficit?

f.          NIHSS Score

4         ANCILLARY INVESTIGATIONS

1. FBS + 2hrs PP

 

2. HbA1c

c.         Serum Lipids : Total chol [      ]           LDL[      ]      Tg [       ]          Hdl[       ]                        

d.         ECG AF

e.         CT Scan

f.        HIV status

ASSESSMENT TOOLS

1).        NATIONAL INSTITUTE OF HEALTH STROKE SCALE (NIHSS)

 

Level of Consciousness

O         =          Alert, Keenly responsive.

1          =          Drowsy, Arousable by minor stimulation of Obey,

answer, or respond.

2.         =          Responds only with reflex motor or atomic effects, or totally

                        unresponsive.

 

Level of Consciousness Question: Patient are asked the month and their age.

O         =          Both Correct or language barrier

1          =          One Correct

2          =          Both incorrect or unable to response

 

Level of Consciousness Question: the patient is asked to close the eye and the hand.

O         =          Both Correct or Language barrier

1          =          One Correct

2          =          Both incorrect or unable to respond

 

Best Visual: Test vision in each field to finger movement simultaneously.

O         =          Normal or Old Blindness

1          =          Asymmetry or partial hemianopia

2          =          complete hemianopia

3          =          Bilateral hamianopia or coma

 

Best weakness

O         =          Full range

1          =          Partial gaze palsy or isolated nerve palsy

2          =          Forced deviation or total gaze paresis not overcome by

Doll’s eye maneuver.

Facial weakness

O         =          none or sedated

1          =          minor (just loss of naso-labial fold)

2          =          partial (lower half of the face)

3          =          Complete (all half involved) or coma

 

Best Motor Left arm: The patients hold the outstretched at 90 degrees.

O         =          limp hold degrees for full 10 seconds, effusion or

                        Amputation.

1          =          limp hold 90 degrees position, but drifts before full

10 seconds

2          =          Limp cannot hold 90 degree position for full 10 seconds,

                        some effort against gravity

3          =          Limp falls, no fall effort against gravity.

4          =          No movement.

 

Best Motor Right Arm: The patient holds the arm outstretched at 90 degrees

O         =          Limp hold 90 degrees for full 10 seconds, effusion or

Amputation

1          =          Limp hold 90 degrees position, but drift before full 10 seconds

2          =          Limp cannot hold 90 degrees position for full 10 seconds,

some limp movement.

3          =          Limp falls, no fall effort against gravity

4          =          No movement

 

Best Motor Left Leg: the patient elevates the leg at 30 degree for 5 seconds

O         =          Leg holds 30-degree positions for 5 seconds, effusion or amputation

1          =          Leg falls to intermediate positions for 5 seconds

2          =          Leg falls to bed by 5 second, some effort against gravity

3          =          leg falls to bed immediately, no resistance against gravity

4          =          No movement

 

Best Motor Right Leg: The patient elevates the leg at 30 degree for 5 seconds.

O         =          leg holds 30-degrees position for 5 seconds, effusion or

                        amputation

1          =          Leg falls intermediate position by end of 5 second

2          =          Leg falls to bed by 5 second, some effort against gravity

3          =          Leg falls to bed immediately, no resistance against gravity

4          =          no movement

 

Limp Ataxia: Finger-to-nose and heel to shin test

O         =          Absent (no movement of limp), cannot be examined

1          =          Ataxia present in one limb

2          =          Ataxia present in two limbs

 

Sensory: Pin prick: If level of consciousness is impaired, score only if a grimace pr asymmetric withdrawal is present.

O         =          Normal, sedated or amputation

1          =          mild to Moderate. Patient feels pin prick less sharp, but is

                        aware of being touched.

 

Neglect

O         =          No Neglect or selected

1          =          Visual, tactile or auditory hemi-inatention

2          =          Profound hemi-inattention to more than one modality

Dysarthria

O         =          Normal

1          =          Mild to moderate slurring of words, can be understood

2          =          Speech slurred, unintelligible

 

Best Language: Standard picture are named

O         =          Normal

1          =          Mild to moderate errors, word-finding errors, or paraphasias

                        Impairment of communication by their comprehension or

expression.

2          =          Severe: Fully developed Broca’s (expensive) or Wernicke’s

(receptive) aphasia.

3          =          Mute or global aphasia or coma

 

BARTHEL INDEX

Feeding

O         =          Unable

5          =          Needs help cutting, spreading butter etc or requires

                        modified Diet

10        =          Independent

 

Bathing

O         =          Dependent

5          =          Independent (or shower)

 

Grooming

O         =          Needs help with personal care

5          =          Independent face/hair/teeth/shaving (implements provided)

 

Dressing

O         =          Dependent

5          =          Needs help but can do but half unaided

10        =          Independent (including buttons, zips, lace etc)

 

Bowels

O         =          Incontinent (or needs to be given enemas)

5          =          Occasional accident

10        =          Continent

 

Bladder

O         =          incontinent, or catheterized and unable to manage alone

5          =          Occasional accident

10        =          Continent

 

Toilet Use

O         =          Dependent

5          =          needs some help, but can do something alone

10        =          independent (on and off, dressing, wiping)

 

Transfers (Bed to Chair and Back)

O         =          unable, no sitting balance

5          =          Major help (one or two people, physical) can sit

10        =          Minor help (verbal or physical)

15        =          Independent

 

Mobility (on level surface)

0          =          Immobile or <50 yards

5          =          wheelchair independent, including corners, .50 yards

10        =          Walks with help of one person (verbal or physical) > 50 yards

10        =          Independent (but may use any aid; for example, stick)

 > 50) yards

 

Stairs                

O         =          Unable

5          =          needs help (verbal, physical, carrying aid)

10        =          Independent

Total (0 – 100):

 

 

 

3. MODIFIED RANKIN SCALE

Score              Description

O                     No symptoms

1                      No significant disability despite symptoms, able to carry out                                                           all usual duties and activities.

2                      Slight disability, unable to carry out all previous activities but to look   after own affairs without assistance.

3.             Moderate disability, requiring some help, but able to walk     without

                        assistance

4                      Moderately severe disability, unable to walk without assistance and unable attend to own bodily needs without assistance.

5.                    Severe disability bedridden, incontinent and requiring constant nursing care and attention

 6.                    Dead

Total (0 -6).

 

CONSENT FORM

THE PROFILE OF STROKE IN JOS UNIVERSITY TEACHING HOSPITAL

(To be explained to the patient or relative in the language they understand best)

I am Dr Osaigbovo Godwin Osawaru, a consultant physician/Neurologist in the department of internal Medicine. I will like you to take part in the study titled, “The profile of stroke in Jos university teaching hospital”. The result of this study will give us a better understanding of how to take care of stroke patients. I will examine you fully while on admission. You will also undergo some blood test and a brain CT scan which is an imaging of your brain and is very important for anybody with stroke. When you come for follow-up at 6 weeks and 3 months, I will reexamine you to compare with your present state. This once again will cause you no discomfort. Your failure to participate, or withdraw from the study at any point, will not in any way hinder your management. Every information and finding about your condition will be treated with utmost confidentiality.

 

Signature………………………………………

Date………………………………………………