sex differences in clinical characteristics and outcomes after intracerebral haemorrhage: results...

Sex Differences in Clinical Characteristics and Outcomes after Intracerebral Haemorrhage: Results from a 12-month Prospective Stroke Registry in Nanjing, China

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Vita Kusuma Rahmawati

Zhou et al. BMC Neurology 2014, 14:172

Journal Reading

Background

This study aimed to investigate the sex differences in clinical characteristics, severity and outcomes of Chinese ICH patients.

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Growing studies worldwide

Most studies focus on ischemic stroke

Study results are conflicting

Most of previous studies are

retrospective

Most of previous studies are in short term follow up

There is uncertainty surrounding the differences in outcomes after intracerebralhaemorrhage (ICH) between men and women.

Method Subjects

All consecutive patients, admitted to the neurology department of Nanjing First Hospital with acute stroke (ischemic stroke, intracerebral haemorrhage, or subarachnoid haemorrhage); between August 2004 and August 2008.

Inclusion criteria:◦ Patients with acute ICH within 14 days of symptom onset who had a complete 12-month follow up

◦ Intraventricular haemorrhage secondary to ICH

Exclusion criteria: primary intraventricular haemorrhage.

Clinical diagnosis of stroke was made according to the WHO criteria and was confirmed by brain CT or MRI scans.

Nanjing First Hospital Stroke Registry (NFHSR), 1 year prospective follow up.

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Method Data Collection

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Characteristic Definition

Risk factor Risk factors included smoking and alcohol consumption status, presence of hypertension, diabetes and hypercholesterolemia, history of stroke, ischemic heart disease (including myocardial infarction and angina pectoris) and atrial fibrillation

Current smoker Patients who had smoked >1 cigarette/day for more than one year

Current drinker Patients who had consumed alcohol >50 ml/day for at least one year

Hypertension systolic blood pressure (SBP) >140 mm Hg and/ or diastolic blood pressure (DBP) >90 mm Hg or current use of antihypertensive agents

Diabetes fasting serum glucose level >7.0 mmol/L or current use of antidiabetic drugs

Hypercholesterolemia fasting serum cholesterol level >5.72 mmol/L or current use of lipid-lowering medicines

pre-stroke dependency a modified Rankin Scale (mRS) score of 3–5

Stroke severity evaluated using the Glasgow Coma Scale (GCS) and the National Institutes of Health Stroke Scale (NIHSS)

Location of bleeding deep cerebral (periventricular white matter, caudate, globus pallidus, putamen, internal capsule, and thalamus), lobar, cerebellar and brain stem

Baseline characteristic: patient demographics (age and gender), risk factors, pre-stroke dependency, onset-to-door time (ODT), stroke severity, laboratory tests, and brain imaging data

Method Outcomes followed up at 3, 6 and 12 months after ICH by telephone interview or questionnaire

Statistycal Analysis SPSS version 16; p<0.05

Chi-square test for categorical variables and the Student t-test or Wilcoxon test for continuous variables.

The gender differences in outcomes were ascertained by logistic regression models.

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Characteristic Definition

Death The cumulative all-cause death

Dependency a mRS score of 3–5

Result Gender specific clinical characteristic

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Gender specific clinical characteristic

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Women:• Lower proportion of current smokers and current drinkers• Higher NIHSS score


Result Gender specific outcomes at 3, 6, and 12 months after ICH

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Result

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Discussion Clinical characteristic women had more serious forms of ICH.

Women had an increased risk of death or dependency at 3 month after ICH, which may be driven by differences in dependency between the gender groups.

Women had a higher risk of dependency at 3 and 6 months after ICH.

The worse outcome in female is likely to be in part attributable to more severe ICH at baseline.

There was no significant sex difference in death at 3, 6 and 12 months after ICH.

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Strength and LimitationStrength Limitation

Prospective design, 12-month follow up Single-centre, urban setting, teaching hospital

High follow up rate (94,5%) Not all ICH patients in the study area and in the hospital were covered

Relatively large sample size Missing data or lost to follow up excluded from analysis

Selection bias in stroke registry

No information in ICH hematoma volume in this registry

Paucity data on the management and care of ICH patients may influenced the gender differences in ICH outcome

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Journal Critical Appraisal

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Journal Search

P •Patients with intracerebral haemorrhage

I •Sex differences women

c •Men

o •Clinical characteristic and outcome

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Design, Focus, and Worksheet

•Prospective cohortDesign

•PrognosisFocus

•Prognosis Worksheet

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RAMMBO Validity Answer

Recruitment Was a defined representative

sample of patients assembled

at a common (usually early)

point in the course of their

disease?

Yes, the Method section

describes the stage at which patients entered the study and provides informationabout patient recruitment.


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Adjustment How were patients treated? If subgroups with different prognoses are identified, did adjustment for important prognostic factors take place?

Yes, method clearly shows detailed

information of baseline characteristics and

outcomes; and their definitions.

There were adjustments in the analysis data,

they are showed in table 2.

Maintenance Was the comparable status of the study

groups maintained through equal

management?

Yes, the method section shows information on the management of the study groups during the follow-up period (12-months)

Was the follow up has been done in

enough and adequate time?

Yes, during 12-months follow up period, the result section say 615 subjects were allocated to each group (table 1) and 615 subjects were actually included in the analysis.


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MeasurementBlindingOutcome

Were the subjects and assessors kept ‘blind’ to which treatment was being received and/or were the measures objective?

Yes, the outcomes are measured based on Nanjing First Hospital Stroke Registry (NFHSR) death was defined as the cumulative all-cause death, dependency was measured by a mRSscore of 3-5.The outcomes death and dependency were objective.

Journal Critical AppraisalImportancy Answer

Were the statistical and clinical meaning from this research can be known well?

Yes

What kind of measurement that was used and how much the effect of the indicator can related to the outcome of the subject?

OR measurement, with adjustment for confounding factors.

Could the outcome of this research were merely accident?p-value?Confidence interval (CI)?

p-value: 0.05, with 95% CI,So the outcome were not happen accidentally.

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OR =195%CI melewati angka 1

OR >195%CI di atas angka 1

Journal Critical AppraisalNo Applicability Answer

1 Were the patient quite similar to the patients in the study? Yes

2 Were the indicator in this study can be applied to the management of

patients in your neighborhood?

No

3 Were the outcomes of this research important for your patient? Yes

4 Will the potential benefit is greater than the potential harm when this

indicator is applied to your patients ?

Yes

5 Will the results of this research can be integrated with the values and

expectations of your patients ?

Yes

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Riskesdas 2013

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Yudiarto, Fenny et al. 2014. Indonesian Stroke Registry (S12.003). Neurology 8 April 2014 Vol 82 No. 10 Suplement S12.003

Journal Critical AppraisalCONCLUSION

This journal can be classifed as a VALID journal

IMPORTANCY in this journal were described well

Result from the research in this journal is not APPLICABLE in Indonesia

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sex differences in clinical characteristics and outcomes after intracerebral haemorrhage: results...

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