Research Critique Work Sheet Quantitative Research Prepared by Polly Ryan Title of Study Comparison of Inhaled Isopropyl Alcohol and Intravenous Ondansetron for Treatment of Postoperative Nausea Year of Publication 2003 Authors (list first two) Winston, A. Rinehart, R. Riley, G. __X___ Clinical experience _____ Research expertise _____ Prior publications __X___ Funding _____ Non-federal funding __X___ Federal funding _____ Non US governmental funding Purpose Compare the efficacy of inhaled isopropyl alcohol and IV ondansetron for the treatment and control of PON in groups of women undergoing outpatient gynecological laparoscopic procedures. Review of Literature __X___ Logical _X____ Clarity __X___ Current and comprehensive references _____ Pros/Cons presented _____ Gaps in knowledge identified _____ Importance of study Comments: The review of literature focused on why PONV happens, the physiological mechanisms. The authors barely touched on previous research done. Overviewed the IV antiemetic chosen. Did mention cost of POSN, time spent in the PACU. How it could be beneficial to investigate this but it was brief and non specific. References were from 1987 to 2002. All references looked specifically at nausea and vomiting. Very brief introduction before the study was introduced. Research Question/Hypothesis Is the use of inhaled isopropyl alcohol more beneficial in reducing PONV than IV ondansetron. Study Design __X_ _____ _____ _____ _____ ____ Experimental/Randomized Clinical Trial Quasi-Experimental Correlation Descriptive Program Evaluation Other Sample and Setting General description of participants (age, gender, etc.) 100 women older than 18, ASA status I or II, undergoing a diagnostic laparoscopic, operative laparoscopy, or laparoscopic bilateral tubal occlusion. Important Inclusion and Exclusion Criteria: Exclusion: sensitivity to IPA or ondansetron, inability to breathe through nose, pregnant, using disulfiram, preexisting nausea, alcoholism. Groups _____ True control group _____ Usual care group ___X__ Intervention group(s) Name or brief description of group: Control: received 4mg IV ondansetron, maybe be repeated times one. Name or brief description of group: Intervention: use of an alcohol prep pad, 3 consecutive deep breaths through the nose. May be repeated times one. Type of Sample Probability ___X_ Simple Random Sampling _____ Stratified Random Sampling _____ Cluster _____ Systematic _____ _____ _____ _____ Non-Probability Convenience Quota Purposive Snowball Instruments Measurement Tool What did it measure? Information about the measure: # or type questions; reliability or validity; inter-rater reliability; other Numeric rating scale Degree of nausea experienced on a 1 to 10 scale Not mentioned. Most commonly used scale for self report. Relies on self report. Detailed Description of the Intervention Specific Steps of the intervention Either put in ondansetron group or alcohol group when first reporting nausea in the PACU. Intervention was standardized in both groups. Knowledge and skills needed to deliver intervention (education, licensure, etc) Giving IV medications require a MD, RN. Inhalation treatment does not require any specific skills. Time to deliver/use the intervention Time was that spent in the PACU. How frequently does it need to be delivered and what is the time interval in between delivery? Alcohol: 3 consecutive deep breaths, up to two treatments Ondansetron: 4mg IV every 15 minutes for up to two doses. IRB Approval __X___ Yes _____ Does not mention Threats to Validity Threats to Internal Validity _____ History _____ Maturation ___X__ Testing _____ Instrumentation _____ Mortality _____ Selection Bias Threats to External Validity __X___ Novelty effects _____ Interaction of history and treatment _____ Experimenter effect _____ Measurement effect Results Demographic characteristics were similar in both groups, equal number of surgical procedures between groups. 41 of 100 experienced nausea. 29 in alcohol, 12 in control. No statistically significant differences in mean verbal NRS scores except at 5, 10 and 15 min mark. Time of reduced nausea of 6.3(alcohol) vs. 27.7(ondansetron). Did not influence total time spent in PACU. Alcohol group did report more episodes of nausea at home during first 24 hours. 8 of inhalation and 2 of ondansetron did not receive any relief from their intervention, other means were used. Major Findings Decrease in nausea faster in inhalation group. Not better long term effects. No impact on PACU stay. Strengths and Weaknesses of Study Strength Specific surgical population Randomized Consistent and regular interventions Practical day to day setting Weakness Small sample size No blinded study intervention Self reported data Ranking of Scientific Merit Agency for Health Care and Research Evaluate each study – Assign a quality number to the study Evaluate all articles within the collection of studies reviewed – Assign a Letter •Types of Evidence ____ Level 1 = meta-analysis __X__ Level II = experimental studies ____ Level III = well-designed, quasi-experimental studies ____ Level IV = well designed, non-experimental studies ____ Level V = case reports and clinical examples