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565313071 Page 1 of 8 REMEMBER TO SAVE THE BLANK WORKSHEET TEMPLATE USING THE FILENAME FORMAT 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 565313071 Page 2 of 8 REMEMBER TO SAVE THE BLANK WORKSHEET TEMPLATE USING THE FILENAME FORMAT 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 565313071 Page 3 of 8 REMEMBER TO SAVE THE BLANK WORKSHEET TEMPLATE USING THE FILENAME FORMAT 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 565313071 Page 4 of 8 REMEMBER TO SAVE THE BLANK WORKSHEET TEMPLATE USING THE FILENAME FORMAT 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). 565313071 Page 5 of 8 REMEMBER TO SAVE THE BLANK WORKSHEET TEMPLATE USING THE FILENAME FORMAT 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. 565313071 Page 6 of 8 REMEMBER TO SAVE THE BLANK WORKSHEET TEMPLATE USING THE FILENAME FORMAT 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. 565313071 Page 7 of 8 REMEMBER TO SAVE THE BLANK WORKSHEET TEMPLATE USING THE FILENAME FORMAT 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 565313071 Page 8 of 8 REMEMBER TO SAVE THE BLANK WORKSHEET TEMPLATE USING THE FILENAME FORMAT 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. *Type the citation marker in the first field and then paste the full citation into the second field. You can copy the full citation from EndNote by selecting the citation, then copying the FORMATTED citation using the short cut, Ctrl-K. After you copy the citation, go back to this document and position the cursor in the field, then paste the citation into the document (use Ctrl-V). For each new citation press Tab to move down to start a new field.