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Sharma M, Clark H, Armour T, et al. Acute Stroke: Evaluation and Treatment. Rockville (MD): Agency for Healthcare Research and Quality (US); 2005 Jul. (Evidence Reports/Technology Assessments, No. 127.)

  • This publication is provided for historical reference only and the information may be out of date.

This publication is provided for historical reference only and the information may be out of date.

Cover of Acute Stroke: Evaluation and Treatment

Acute Stroke: Evaluation and Treatment.

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Appendix C. Data Assessment and Data Abstraction Forms

Relevance Assessment Forms

Level 1 Screening of Titles and Abstracts—Eligibility Criteria

Inclusion Criteria

1. Does this report describe a study involving human participants?

  • Yes
  • No
  • Can't tell

2. Does this study include adults (>16 years old) with Acute Stroke (i.e., intracerebral hemorrhage [ICH] or ischemic stroke [IS])?

  • Yes
  • No
  • Can't tell

3. Is the purpose of the study to investigate the effect (e.g., efficacy, effectiveness, mortality, adverse events) of the following interventions:

a)

surgery for ICH, or

b)

antihypertensive therapy for ICH, or

c)

intra-arterial thrombolytic therapy for IS, or

d)

normalization of blood glucose levels for IS, or

e)

mechanical clot disruption for IS, or

f)

timing of thrombolytic therapy in IS, or

g)

pretreatment CT scoring system for IS, or

h)

pretreatment MRI scoring system for IS, or

i)

CT perfusion/angiography for IS, or

j)

community education programs for acute stroke, or

k)

use of designated centers for acute stroke, or

l)

use of ER protocols for management of acute stroke?

  • Yes
  • No
  • Can't tell

Exclusion Criteria

4. If this is a narrative or systematic review opinion piece or editorial, letter, guideline or policy paper, etc., does it exclusively describe studies already reported elsewhere (i.e., it does not present any empirical evidence published for the first time)?

  • Yes
  • No
  • Can't tell

5. Is this study reported in English?

  • Yes
  • No
  • Can't tell

6. Comments:

Level 2 Screening of Full Articles—Eligibility Criteria

Inclusion Criteria

1. Is this study reported in English?

  • Yes
  • No

2. Does this report describe a study involving human participants?

  • Yes
  • No
  • Can't tell

3. Does this study include adults (>16 years old) with Acute Stroke (i.e., intracerebral hemorrhage [ICH] or ischemic stroke [IS])?

  • Yes
  • No
  • Can't tell

4. Is the purpose of the study to investigate the effect (e.g., efficacy, effectiveness, mortality, adverse events) of the following interventions:

a)

Surgery for ICH, or

b)

Antihypertensive therapy for ICH, or

c)

Intra-arterial thrombolytic therapy for IS, or

d)

Normalization of blood glucose levels for IS, or

e)

Mechanical clot disruption for IS, or

f)

Timing of thrombolytic therapy in IS, or

g)

Pretreatment CT scoring system for IS, or

h)

Pretreatment MRI scoring system for IS, or

i)

CT perfusion/angiography for IS, or

j)

Community education programs for acute stroke, or

k)

Use of designated centers for acute stroke, or

l)

Use of ER protocols for management of acute stroke?

  • Yes
  • No
  • Can't tell

5. To which of the following topics does this study belong?

(Check all that apply)

  • a) Surgery for ICH
  • b) Antihypertensive therapy for ICH
  • c) Intra-arterial thrombolytic therapy for IS
  • d) Normalization of blood glucose levels for IS
  • e) Mechanical clot disruption for IS
  • f) Timing of thrombolytic therapy in IS
  • g) Pretreatment CT scoring system for IS
  • h) Pretreatment MRI scoring system for IS
  • i) CT perfusion/angiography for IS
  • j) Community education programs for acute stroke
  • k) Use of designated centers for acute stroke
  • l) Use of ER protocols for management of acute stroke

Exclusion Criteria

6. Is this study one of the following?

  • Narrative review, or
  • Systematic review, or
  • Opinion piece, or
  • Editorial, or
  • Letter, or
  • Guideline, or
  • Policy paper etc.
    • Yes
    • No
    • Can't tell

7. If answer to the above question is YES, does this article report original research data? (i.e., presents any empirical evidence published for the first time)

  • Yes
  • No
  • Can't tell

8. Was this full reference available by the stop date for relevance assessment at Level II?

  • unable to obtain for review by inclusion deadline
  • able to obtain for review by inclusion deadline

9. Comments

Study Type Classification

1. Does this report belong to the following Levels of Evidence (see below)?

  • yes
  • no

2. Level of Evidence of this report (select one)

  • RCT parallel design
  • RCT crossover design
  • RCT factorial design
  • Controlled clinical trial (non-RCT)
  • Multiple prospective cohorts
  • At least one prospective cohort & one retrospective cohort
  • Case-control
  • Cross-sectional
  • Before-after (pre-post)
  • Single prospective cohort
  • Single retrospective cohort
  • Case series (noncomparative)
  • Case study
  • Sequential
  • Cross-national ecological analysis
  • Other:

Data Abstraction Forms

General Stroke Data Extraction

1.

Initials of reviewer:

2.

Reference identification # (Refid):

3.

Author, Year, Location [number of sites]:

4.

Number of unique studies that this report describes:

5.

If other included reports refer to this same study, provide the Refid(s):

6.

Publication status (select one):

  • Journal publication
  • Grey Literature (e.g., conference paper/abstract, internet document, Book chapter, thesis, etc)
  • Other
7.

Funding source type (select all that apply):

  • Government (Specify)
  • Industry (Specify)
  • Private (non-industry) (Specify)
  • Hospital (Specify)
  • Other (Specify)
  • Not reported
8.

Total # of individuals screened:

9.

Full sample size (enrolled in study):

10.

Full sample size (completing study):

11.

Full sample's percentage of male participants:

12.

Comments, including notable differences between study arms / cohorts re ‘% male participants’:

13.

Mean age (SD/SE; range) of all study participants:

14.

Comments, including notable differences between study arms/cohorts re age:

15.

From which racial groups were participants drawn (select all that apply)?

  • Black/African ancestry
  • Native North American
  • Hispanic
  • Asian
  • Caucasian/European
  • Other (specify)
  • Not reported
  • Can't tell
16.

Specify each racial group's percentage/proportion of full sample:

17.

Comments, including notable differences between study arms/cohorts re racial composition:

18.

Specify each socioeconomic status (i.e., employment status, insurance, income, education, married) group's percentage/proportion of full sample:

19.

Comments, including notable differences between study arms/cohorts re socioeconomic status:

20.

Eligibility criteria (select all):

  • List of study's inclusion criteria:
  • List of study's exclusion criteria:
21.

Type of setting where study was conducted (e.g., Emergency room, Teaching Hospital, etc):

22.

Adverse events/ side effects reported in the present, per study arm/cohort:

23.

Number of drop outs/withdrawals, per study arm/cohort:

24.

Study duration, including units (includes run-in period duration, washout duration, intervention length, etc.):

25.

Comment box (optional):

Specific Acute Stroke Data Extraction

1.

Initials of reviewer:

2.

Reference identification # (Refid):

3.

Author, Year, Location [number of sites]:

4.

Number of unique studies that this report describes:

5.

If other included reports refer to this same study, provide the Refid(s):

6.

How was acute stroke defined?

7.

How was acute stroke diagnosed?

8.

How was Acute Stroke classified (e.g. Ischemic, Hemorrhagic)?

9.

How was the severity of Acute Stroke defined?

10.

Describe the full sample's baseline level of Acute Stroke symptoms and/or signs severity:

11.

Comments, including notable differences between arms/cohorts re participants' baseline level of Acute Stroke symptoms and/or signs severity:

12.

Time since Stroke onset to intervention (specify: mean; range):

13.

Comments, including notable differences between arms/cohorts re participants' baseline disease duration:

14.

Pre-study medication(s) or treatments for Acute Stroke, including dose/ frequency:

15.

Concurrent/antecedent conditions (select all that apply)

  • Arterial Hypertension
  • Diabetes Mellitus
  • Dyslipidemia
  • Smoking
  • Other
  • Not Reported
16.

Specify the percentage/proportion of the whole sample re each type of each concurrent/antecedent condition:

17.

Comments, including notable differences between study arms/cohorts re concurrent/antecedent conditions:

18.

Specify pre-study medications or treatments for each concurrent/antecedent condition, with dose/frequency:

19.

Comments, including notable differences between study arms/cohorts re pre-study medications/treatments:

20.

Which question(s) this study answer (select all that apply):

  • (A) Surgery for ICH
  • (B) Antihypertensive therapy for ICH
  • (C) Intra-arterial thrombolytic therapy for IS
  • (D) Normalization of blood glucose levels for IS
  • (E) Mechanical clot disruption for IS
  • (F) Timing of Thrombolytic therapy for IS
  • (G) Pretreatment CT scoring system for IS
  • (H) Pretreatment MRI scoring system for IS
  • (I) CT perfusion/angiography for IS
  • (J) Community education programs for acute stroke
  • (K) Use of designated centres for acute stroke
  • (L) Use of ER protocols for management of acute stroke
21.

Participants were enrolled according to which criterion (select one)?

  • Intention-to-treat (all randomized/enrolled)
  • Those receiving at least one dose
  • Those completing the study (i.e., with follow-up data)
  • Can't tell
  • Not applicable
  • Other:
22.

Cointerventions: Medications and/or treatments allowed or permitted during the study period:

23.

Comments, including notable differences between study arms/cohorts re on-study medications/treatments:

24.

Type of intervention (Select one if applicable)

Answer for Interventions

(B) Antihypertensive Therapy for ICH &/or

(D) Normalization of blood glucose levels for IS

  • Drug (see below)
  • Target (give target i.e., blood pressure, glucose level)
  • Not applicable
25.

Imaging tests performed on-study: (check all that apply)

Answer for Interventions

(G) Pretreatment CT scoring system for IS,

(H) Pretreatment MRI scoring system for IS, &/or

(I) CT perfusion/angiography for IS

  • CT
  • CT perfusion
  • CT angio
  • MRI (other than DWI/PWI)
  • MRI DWI/PWI
  • Other
  • Not reported
  • Not applicable
26.

Describe listed characteristics of imaging tests (see above question) used to make the intervention decision.

Answer for Interventions

(G) Pretreatment CT scoring system for IS,

(H) Pretreatment MRI scoring system for IS, &/or

(I) CT perfusion/angiography for IS

27.

‘Centre’ definition used: (select all that apply)

Answer for Intervention

(K) Use of designated centres for acute stroke

  • Brain Attack Coalition (BAC) (definition at bottom)
  • Other (describe)
28.

Intervention components (check all that apply)

Answer for Intervention

(L) Use of ER protocols for management of acute stroke

  • Stroke team
  • 24 hour CT
  • Written protocol orders
  • Professional education
  • Drug storage in ER
  • Other
29.

Study GROUP 1: Intervention of interest (e.g., Surgery for ICH): (Select all)

  • Define study group (e.g., by time window since stroke onset):
  • Intervention/ exposure/ procedure type:
  • Dose/ frequency/ timing (if apply):
  • Intervention Length:
  • N enrolled/completed:
30.

Study GROUP 2: first comparator (e.g., placebo, other type of intervention): (Select all):

  • Define study group (e.g., by time window since stroke onset):
  • Intervention/ exposure/ procedure type:
  • Dose/ frequency/ timing (if apply):
  • Intervention Length:
  • N enrolled/completed:
31.

Study GROUP 3: (if applicable)

  • Define study group (e.g., by time window since stroke onset):
  • Intervention/ exposure/ procedure type:
  • Dose/ frequency/ timing (if apply):
  • Intervention Length:
  • N enrolled/completed:
32.

Study GROUP 4: (if applicable)

  • Define study group (e.g., by time window since stroke onset):
  • Intervention/ exposure/ procedure type:
  • Dose/ frequency/ timing (if apply):
  • Intervention Length:
  • N enrolled/completed:
33.

Outcome measures with significance (e.g., Surgery S better than no surgery) (select all that apply)

  • NIHSS
  • mRS (Modified Rankin Scale)
  • Barthel
  • FIM
  • Time to treatment
  • Time to presentation to ER (arrival)
  • Other (describe all the outcomes assessed not mentioned above)
34.

Identify any problems with the research design (e.g., definition of placebo/control(s); inappropriateness of run-in and washout periods), or its implementation:

35.

Comment box (optional):

Quality Assessment Forms—RCTs

Jadad Scale

DescriptorYesNo
Was the study described as randomized (this includes the use of words such as randomly, random, and randomization)?
The method used to generate the sequence of randomization was described and it was appropriate (table of random numbers, computer generated, etc)
Was the report of allocation concealment:Adequate □Inadequate □Unclear □
Was the study described as double blind?
The method of double blinding was described and it was appropriate (identical placebo, active placebo, dummy, etc)?
Was there a description of withdrawals and dropouts?

Note: Clinical controlled trials were assessed out of a possible score of 3 according to a modified Jadad scale

Allocation Concealment - Refers to the technique used to implement the randomization sequence, not to generate it.

Adequate
  • Sequentially numbered, opaque, sealed envelopes (SNOSE)
  • Pharmacy controlled
  • Numbered or ordered containers
  • Central randomization - for example by telephone to a trials office or other method whose description contained elements convincing of concealment - for example a secure computer assisted method.
Inadequate
  • Alternation
  • Reference to case record numbers or to dates of birth
Unclear
  • No mention of an allocation concealment approach at all
  • An approach that does not fall into either adequate or inadequate allocation concealment

Quality Assessment Forms—Case-Control and Cohort Studies

Newcastle-Ottawa Scale (NOS)

DescriptorYesNoCan't tell
Was the therapeutic intervention reported?
Were the inclusion/exclusion criteria reported?
Was follow-up reported as an inclusion criterion?
Was the sample size determination reported (cases accrued consecutively or non consecutively over a specified time period)?
Were the sample size calculations (and any assumptions) reported?
Was the time period for accrual of cases and whether they were accumulated prospectively or retrospectively reported?
Were the sources of participants (same or different clinicians, one or more center) reported?
Were how the outcome assessments made and who made them reported?
Was blinding reported?
Were the primary and secondary measures reported?
Was the timing of the outcome measures reported?
Was a follow-up schedule reported?
Were efforts used to maintain follow-up with participants reported?
Did the authors report on compliance with follow-up?
Was the method of data collection reported?
Were any participant exclusions from data analysis reported?
Was the statistical approach for analyzing the data reported?
Did the authors report any missing data and how it was handled in the data analysis?
Did the authors report any adverse events?

Quality Assessment Forms—Noncomparative Case-Series Studies

Quality assessment YesPartialNoN/A
1. Question / objective sufficiently described?
2. Design evident and appropriate to answer study question?
3. Subject characteristics sufficiently described?
4. Subjects appropriate to the study question?
5. Controls used and appropriate? (if no control, check no)
6. Method of subject selection described and appropriate?
7. If random allocation to treatment groups was possible, is it described? (if not possible, check n/a)
8. If blinding of investigators to intervention was possible, is it reported? (If not possible, n/a)
9. If blinding of subjects to intervention was possible, is it reported? (If not possible, n/a)1
10. Outcome measure well defined and robust to measurement bias? Means of assessment reported?
11. Confounding accounted for?
12. Sample size adequate?
13. Post hoc power calculations or confidence intervals reported for statistically non-significant results?
14. Statistical analyses appropriate?
15. Statistical tests stated?
16. Exact p-values or confidence intervalls stated?
17. Attrition of subjects and reason for attrition recorded?
18. Results reported in sufficient detail?
19. Do the results support the conclusions?
Sum (items 1–19)

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