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WORKSHEET for PROPOSED Evidence-Based GUIDELINE RECOMMENDATIONS
NOTE: Save worksheet using the following filename format: Taskforce.Topic.Author.Date.Doc where Taskforce is a=ACLS,
b=BLS, p=Pediatric, n=neonatal and i=Interdisciplinary. Use 2 or 3 letter abbreviation for author’s name and 30Jul03 as
sample date format.
Worksheet Author:
Taskforce/Subcommittee: __BLS __ACLS __PEDS ID __PROAD
David Markenson, MD and Peter T. Pons, MD
X__Other: First Aid
Author’s Home Resuscitation Council:
__AHA __ANZCOR __CLAR __ERC __HSFC
__HSFC __RCSA
___IAHF
Date Submitted to Subcommittee: 10 June 2004
__X_Other: American Red
Cross
STEP 1: STATE THE PROPOSAL. State if this is a proposed new guideline; revision to current guideline; or deletion of current guideline.
Existing guideline, practice or training activity, or new guideline:
No existing guideline.
Proposed new guideline:
What is the safety and feasibility of assisting the victim in the administration of the victim’s own selfadministered albuterol in first aid management of a breathing difficulty in the asthmatic patient?
Step 1A: Refine the question; state the question as a positive (or negative) hypothesis. State proposed guideline recommendation as a specific,
positive hypothesis. Use single sentence if possible. Include type of patients; setting (in- /out-of-hospital); specific interventions (dose, route); specific
outcomes (ROSC vs. hospital discharge).
It is feasible, safe and effective to train the lay rescuer to assist a patient having an asthma attack to use their
prescribed inhaler (bronchodilator).
Step 1B: Gather the Evidence; define your search strategy
“Asthma OR breathing difficulty OR shortness of breath” AND “first aid OR lay responders OR lay
persons” were used in combination as keywords to search the available abstracts
List electronic databases searched
Cochrane database (no hits), Medline (314 hits), Embase (no hits), AHA EndNote 7 Master Library (no
hits)
• State major criteria you used to limit your search; state inclusion or exclusion criteria (e.g., only human studies with control group? no animal studies? N subjects
> minimal number? type of methodology? peer-reviewed manuscripts only? no abstract-only studies?)
Search was limited to include studies which involved lay persons and for treatment via inhalation with a
bronchodilator.
• Number of articles/sources meeting criteria for further review:
.
4 studies were identified for further review.
STEP 2: ASSESS THE QUALITY OF EACH STUDY
Step 2A: Determine the Level of Evidence. For each article/source from step 1, assign a level of evidence—based on
study design and methodology.
Level of
Definitions
Evidence
(See manuscript for full details)
Randomized clinical trials or meta-analyses of multiple clinical trials with substantial treatment effects
Level 1
Randomized clinical trials with smaller or less significant treatment effects
Level 2
Prospective, controlled, non-randomized, cohort studies
Level 3
Historic, non-randomized, cohort or case-control studies
Level 4
Case series: patients compiled in serial fashion, lacking a control group
Level 5
Animal studies or mechanical model studies
Level 6
Extrapolations from existing data collected for other purposes, theoretical analyses
Level 7
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Level 8
Rational conjecture (common sense); common practices accepted before evidence-based guidelines
Step 2B: Critically assess each article/source in terms of research design and methods.
Was the study well executed? Suggested criteria appear in the table below. Assess design and methods and provide an overall
rating. Ratings apply within each Level; a Level 1 study can be excellent or poor as a clinical trial, just as a Level 6 study could be
excellent or poor as an animal study. Where applicable, please use a superscripted code (shown below) to categorize the primary
endpoint of each study. For more detailed explanations please see attached assessment form.
Component of
Study and Rating
Design &
Methods
Excellent
Highly appropriate
sample or model,
randomized, proper
controls
AND
Outstanding
accuracy,
precision, and data
collection in its
class
A = Return of spontaneous circulation
B = Survival of event
Good
Highly appropriate
sample or model,
randomized, proper
controls
OR
Outstanding accuracy,
precision, and data
collection in its class
Fair
Adequate,
design, but
possibly biased
Poor
Small or clearly
biased population or
model
Unsatisfactory
Anecdotal, no
controls, off
target end-points
OR
Adequate under
the
circumstances
OR
Weakly defensible in
its class, limited
data or measures
OR
Not defensible in
its class,
insufficient data
or measures
C = Survival to hospital discharge
D = Intact neurological survival
E = Other endpoint
Step 2C: Determine the direction of the results and the statistics: supportive? neutral? opposed?
DIRECTION of study
by results & statistics:
Results
SUPPORT the proposal
Outcome of proposed guideline
superior, to a clinically important
degree, to current approaches
NEUTRAL
Outcome of proposed guideline
no different from current
approach
OPPOSE the proposal
Outcome of proposed guideline
inferior to current approach
Step 2D: Cross-tabulate assessed studies by a) level, b) quality and c) direction (ie, supporting or neutral/
opposing); combine and summarize. Exclude the Poor and Unsatisfactory studies. Sort the Excellent, Good, and Fair quality
studies by both Level and Quality of evidence, and Direction of support in the summary grids below. Use citation marker (e.g. author/
date/source). In the Neutral or Opposing grid use bold font for Opposing studies to distinguish them from merely neutral studies.
Where applicable, please use a superscripted code (shown below) to categorize the primary endpoint of each study.
Supporting Evidence
Quality of Evidence
It is feasible, safe and effective to train the lay rescuer to assist a patient having an asthma attack use their
prescribed inhaler (bronchodilator).
Excellent
Good
Hamid
(1998) e
Simon
(1999) e
Connelan
(1979) e
O’Driscoll
(1992) e
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Fair
1
2
3
4
5
6
7
8
Level of Evidence
A = Return of spontaneous circulation
layperson)
C = Survival to hospital discharge
B = Survival of event
D = Intact neurological survival
E = Other endpoint (effective use by
Neutral or Opposing Evidence
It is feasible, safe and effective to train the lay rescuer to assist a patient having an asthma attack use their prescribed inhaler
(bronchodilator).
Quality of Evidence
Excellent
Good
Fair
1
2
3
4
5
6
7
8
Level of Evidence
A = Return of spontaneous circulation
layperson)
B = Survival of event
C = Survival to hospital discharge
E = Other endpoint (effective use by
D = Intact neurological survival
STEP 3. DETERMINE THE CLASS OF RECOMMENDATION. Select from these summary
definitions.
CLASS
Class I
Definitely recommended. Definitive,
excellent evidence provides support.
Class II:
Acceptable and useful
• Class IIa: Acceptable and useful
Good evidence provides support
• Class IIb: Acceptable and useful
Fair evidence provides support
CLINICAL DEFINITION
• Always acceptable, safe
• Definitely useful
• Proven in both efficacy & effectiveness
• Must be used in the intended manner for
proper clinical indications.
• Safe, acceptable
• Clinically useful
• Not yet confirmed definitively
• Safe, acceptable
• Clinically useful
• Considered treatments of choice
• Safe, acceptable
• Clinically useful
• Considered optional or alternative
REQUIRED LEVEL OF EVIDENCE
• One or more Level 1 studies are present (with rare
exceptions)
• Study results consistently positive and compelling
• Most evidence is positive
• Level 1 studies are absent, or inconsistent, or lack
power
• No evidence of harm
• Generally higher levels of evidence
• Results are consistently positive
• Generally lower or intermediate levels of evidence
• Generally, but not consistently, positive results
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Class III:
Not acceptable, not useful, may be
harmful
Indeterminate
treatments
• Unacceptable
• Not useful clinically
• May be harmful.
• Research just getting started.
• Continuing area of research
• No recommendations until
further research
• No positive high level data
• Some studies suggest or confirm harm.
• Minimal evidence is available
• Higher studies in progress
• Results inconsistent, contradictory
• Results not compelling
STEP 3: DETERMINE THE CLASS OF RECOMMENDATION. State a Class of Recommendation for the Guideline Proposal.
State either a) the intervention, and then the conditions under which the intervention is either Class I, Class IIA, IIB, etc.; or b) the condition, and then whether
the intervention is Class I, Class IIA, IIB, etc.
Indicate if this is a __Condition or _XX_Intervention
It is feasible, safe and effective to train the lay rescuer to assist a patient having an asthma attack use
their prescribed inhaler (bronchodilator).
Final Class of recommendation: __Class I-Definitely Recommended __Class IIa-Acceptable & Useful;
good evidence
_XX_Class IIb-Acceptable & Useful; fair evidence
__Class III – Not Useful; may be harmful
___Indeterminate-minimal evidence or inconsistent
REVIEWER’S PERSPECTIVE AND POTENTIAL CONFLICTS OF INTEREST:
Markenson – Pediatric Critical Care and Emergency Physician, member Advisory Council for First Aid and
Safety of the American Red Cross, no conflicts of interest, no funding from any source relevant to this
worksheet.
Pons - Emergency Physician, member Advisory Council for First Aid and Safety of the American Red Cross,
no conflicts of interest, no funding from any source.
REVIEWER’S FINAL COMMENTS AND ASSESSMENT OF BENEFIT / RISK: Summarize your final evidence integration and the rationale for
the class of recommendation. Describe any mismatches between the evidence and your final Class of Recommendation. “Mismatches” refer to selection of a class
of recommendation that is heavily influenced by other factors than just the evidence. For example, the evidence is strong, but implementation is difficult or
expensive; evidence weak, but future definitive evidence is unlikely to be obtained. Comment on contribution of animal or mechanical model studies to your final
recommendation. Are results within animal studies homogeneous? Are animal results consistent with results from human studies? What is the frequency of
adverse events? What is the possibility of harm? Describe any value or utility judgments you may have made, separate from the evidence. For example, you
believe evidence-supported interventions should be limited to in-hospital use because you think proper use is too difficult for pre-hospital providers. Please include
relevant key figures or tables to support your assessment.
There are no studies which have specifically looked at the ability of lay rescuers to assist patients with asthma
and breathing difficulty to use their medication inhalers. Although there are studies looking at training family
members to assist their children which would be a lay rescuer assisting with administration and old studies of
patient’s ability to detect when to use their inhaler.
However, since the inhaler is designed for use by the lay public (patient) without direct, concurrent, and
professional medical oversight (at the time of use) and delay of administration can be fatal or lead to
prolonged hospitalization, combined with several studies of lay persons such as parents and caregivers
assisting patients with their administration, common sense suggests that training lay rescuers and other
specific groups to recognize the signs and symptoms of asthma and on the techniques of assisting an
individual with administration of an inhaled bronchodilator should that individual not be able to administer it
himself is appropriate and likely beneficial (Class IIb).
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Preliminary draft/outline/bullet points of Guidelines revision: Include points you think are important for inclusion by the person assigned to
write this section. Use extra pages if necessary.
Publication:
Chapter:
Pages:
Topic and subheading:
If the lay rescuer is going to assist a patient with the use of their inhaler, the following steps and precautions
are appropriate:
The patient should complete as many steps as possible themselves. The lay rescuer should assist only
as needed when:
1. The patient relates a history of asthma
2. The patient states he or she is having asthma symptoms or an asthma attack
3. The patient advises they need assistance to use their quick-relief or rescue inhaler
4. The patient provides the quick-relief inhaler
If the above criteria are met, the lay rescuer should then perform the following actions:
1.
Call 9-1-1 and activate EMS for any asthma patient requiring assistance with an inhaler.
2.
Ensure the prescription is in the patient’s name and is prescribed for “quick relief” or “acute”
attacks. (Note: some inhalers contain long-acting, preventive medication that should NOT be used in the event
of an emergency.)
3.
Ensure that the expiration date of the medication has not been passed.
After completion of these three steps, the lay rescuer may proceed to assist the patient with the
administration of the medication.
CoSTR Statement:
Evidence from 4 studies in adults and children which include 3 cohort studies one of which is
prospective and 2 of which are retrospective combined with extrapolation from another study document the
ability of lay individuals to correctly determine the indications and assist with administration of a
bronchodilator to patients with respiratory distress secondary to bronchoconstriction in the prehospital setting.
Treatment recommendation:
Therefore, lay rescuer assistance with patient administration of bronchodilator therapy for patients
with respiratory distress secondary to bronchoconstriction is recommended (LOE 3,4,7)
Attachments:

Bibliography in electronic form using the Endnote Master Library. It is recommended that the bibliography be provided in annotated
format. This will include the article abstract (if available) and any notes you would like to make providing specific comments on the
quality, methodology and/or conclusions of the study.
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Citation List
Citation Marker
Connellan (1979)
Hamid (1998)
Full Citation*
Connellan, S. J. and R. S. Wilson (1979). "The use of domiciliary nebulised
salbutamol in the treatment of severe emphysema." British Journal of
Clinical Practice 33(5): 135-6.
LOE 4, Good, Supportive Cohort study of home usage which showed that
individuals were able to properly administer and understand the indications
for home nebulized usage of salbutamol. ,)
Hamid, S., J. Kumaradevan, et al. (1998). "Single centre open study to
compare patient recording of PRN salbutamol use on a daily diary card
with actual use as recorded by the MDI compliance monitor." Respiratory
Medicine 92(10): 1188-90.
The aim of this study was to assess the patients' use of inhaled
short acting bronchodilators as rescue therapy during a 4-week study
period. In this study an electronic metered-dose inhaler compliance monitor
(MDI-CM) was used to measure the time and date of actuations of the
device and this information was then compared with the patients' self
reporting diary card (DC). Salbutamol canisters were used in the
compliance monitor. The study was approved by the local ethics
committee, and written informed consent was obtained from all patients.
Patients aged 18 years and over who were either receiving, or in the
investigators opinion required, inhaled salbutamol on a PRN basis were
enrolled for a 4-week monitoring phase during which all rescue salbutamol
used was obtained from the MDI-CM. Patients were recording their use of
salbutamol in the DC each morning and evening. There was a 2-week
follow-up period following completion of the monitoring phase or withdrawal
from the study. Forty-four patients were enrolled and 35 patients completed
the study. The mean age (range) was 43 (20-76) years and mean FEV1
2.32 (0.7-4.0) 1, with male:female ratio of 19:25. Comparison of MDI-CM
and DC recordings showed patients fell into three categories: (1) patients
who used rescue salbutamol appropriately and whose MDI-CM and DC
recordings matched closely; (2) patients who used rescue salbutamol for
acute relief but whose MDI-CM and DC recordings did not correlate and (3)
patients whose use of rescue salbutamol was inappropriate or erratic
according to the MDI-CM but whose DC indicated good compliance. This
category of patients include those who 'dumped' all their salbutamol before
attending clinic appointments. There was no significant difference in the
demographic details or the severity of disease in the three groups.
Recorded use of 'rescue' bronchodilator is frequently used as an indicator
of efficacy for new anti-asthma therapies. This study comparing electronic
data monitoring and remembered rescue salbutamol highlights the
potential errors that can occur without accurate recording systems.
LOE 3, Good, Supportive. This study was designed to determine whether
patient recording of salbutamol usage was accurate. A side finding of this
study was that the majority of patients correctly followed usage indications
with the exception of “dumping” the inhaler prior to clinic visits to obtain
additional prescriptions.
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O’Driscoll (1992)
Simon (1999)
O'Driscoll, B. R., E. A. Kay, et al. (1992). "A long-term prospective
assessment of home nebulizer treatment." Respiratory Medicine 86(4):
317-25.
Forty-nine patients (15 asthma, mean FEV1/FVC 1.3/2.1; 34 COPD,
mean FEV1/FVC 0.7/1.8) were referred for consideration of home
nebulizer treatment. All were monitored for 2 weeks while using their usual
inhaled treatment followed by 2 weeks using a 'Nebuhaler' spacer to
deliver 1 mg of terbutaline and 80 micrograms of ipratoropium bromide (IB)
four times daily. They then borrowed a System 22 nebulizer to selfadminister salbutamol nebulizer solution (5 mg), IB unit dose vials (0.5 mg)
or a mixture of these drugs four times daily for 1 month each. Both
asthmatic and bronchitic patients had a significant rise in their mean daily
peak flow rate (PFR) during home nebulizer treatment (P < 0.03) and the
COPD patients also had a significant PFR rise during Nebuhaler treatment
(P = 0.0004). The mean daily peak flow rates (PFR 1 min-1 were: baseline
179, Nebuhaler 195, salbutamol nebulizer 200, IB nebulizer 198, mixed
nebulizer 216). Four patients failed to respond subjectively or objectively to
either Nebuhaler or nebulizer treatment. Five patients responded well to
Nebuhaler treatment and did not proceed to a home nebulizer trial. Eight
further patients preferred Nebuhaler to nebulizer treatment or could not
tolerate nebulizer treatment (two cases). Thirty-two patients requested
home nebulizer treatment for long-term use (nine salbutamol, five IB, 18
mixture). Twenty-seven of these patients had an increased mean daily
PFR (compared to their usual therapy) while using their chosen nebulized
treatment. The mean increase in PFR for all 32 patients was 191 min-1
(11%).
LOE 7, Good, Supportive. – This study was performed to determine two
different methods of administration but the study did show that the patients
could correctly follow indications for administration,
Simon, H. K. (1999). "Caregiver knowledge and delivery of a commonly
prescribed medication (albuterol) for children." Archives of Pediatrics &
Adolescent Medicine 153(6): 615-8.
OBJECTIVE: To evaluate caregiver knowledge and delivery of a
prescription medication (albuterol) for children. DESIGN: Prospective
convenience sample. PARTICIPANTS: Caregivers listing albuterol as one
of their child's medications. SETTING: Two urban, university-affiliated
pediatric emergency departments. INTERVENTIONS: Caregivers were
asked about their knowledge of the medication, the child's dose, frequency,
duration of use, and where it was prescribed. In a mock scenario, they
measured and demonstrated medication delivery to their child. Common
measuring devices and formulations were offered. RESULTS: Forty-one
caregivers were enrolled. Thirty-six (88%) were high school educated and
39 (95%) had a primary care provider. Twenty-six (63%) were out of
medication, 7 (17%) stated an incorrect dose, 18 (44%) reported an
incorrect frequency, and 10 (24%) stated an inadequate duration of use.
Formulations chosen were liquid (n = 15, 37%), nebulizers (n= 15, 37%),
and inhalers (n = 11, 27%). Metered dosing (metered-dosing inhaler or
premixed solution) were chosen by 22 caregivers (54%), calibrated
measuring tools (droppers, syringes) by 15 (37%), and noncalibrated
delivery devices (teaspoon) by 4 (10%). An improper dose was measured
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by 9 (22%), and the dose intended was inaccurately measured by 7 (17%).
All caregivers using a teaspoon inaccurately measured their intended dose
of the liquid formulation. CONCLUSIONS: Metered dosing and calibrated
measuring devices aided in the accurate delivery of this prescription
medication. However, considerable concern exists with the use of
noncalibrated measuring devices (teaspoons), improper frequency, and
duration of use. Refilling of medication was also a concern since 63% were
out of albuterol. Caregiver education on use, delivery, and refilling of
medications must be stressed and assessed at all emergency department
and primary care visits. In addition, metered dosing and the use of
calibrated measuring devices should be encouraged.
LOE 3 Good, Supportive. – This study evaluated several administration
methods. In this study the MDI were used correctly.
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