Date: December 13th, 2019
Reference: Belisle et al. Video discharge instructions for acute otitis media in children: a randomized controlled open-label trial. AEM December 2019
Guest Skeptic: Dr. Chris Bond is an emergency medicine physician and assistant Professor at the University of Calgary. He is also an avid FOAM supporter/producer through various online outlets including TheSGEM.
Case: An 18-month-old, previously healthy female presents to the emergency department with 24 hours of fever. The past few days the parents note there has been some rhinorrhea and cough. She looks well, immunizations are up to date and her examination reveals right sided acute otitis media (AOM). When discussing discharge instructions for her AOM, you wonder whether having the parents watch a video will be more beneficial for the child’s symptoms, rather than giving the parents oral instructions with a paper handout.
Background: AOM is the second most commonly diagnosed illness in children and the most common indication for antibiotic prescription [1-2]. There are significant costs associated with AOM and parents often bring their children to health care providers for evaluation of pain and fever [3-4]. More than one third of children experience pain, fever or both three to seven days following treatment, and nearly seventy-five percent of parents identify pain and disturbed sleep as the most important sources of AOM related burden [5-6].
There is significant parental uncertainty regarding treatment of AOM and less than 30% of US parents receive instructions on appropriate analgesia for their children [7-8]. Discharge instruction complexity and inadequate comprehension is associated with medication errors, suboptimal post-discharge care and unnecessary recidivism [9-12]. Medication errors can be reduced using standardized discharge instructions, and parents prefer these to verbal summaries [13-15].
Video discharge instructions have been shown to be preferred over paper instructions in many pediatric presentations, however no study has explored the effectiveness of video instructions for AOM [16-17].
Clinical Question: Are video discharge instructions superior to a paper handout with respect to the Acute Otitis Media – Symptom Severity Score (AOM-SOS)?
Reference: Belisle et al. Video discharge instructions for acute otitis media in children: a randomized controlled open-label trial. AEM December 2019
- Population: Parents of children age 6 months to 17 years with a chief complaint of otalgia in the setting of URTI and where the treating physician was at least 50% certain of a clinical diagnosis if AOM. Diagnostic certainty was on a 100mm visual analog scale based on the physicians’ rate of color photos of AOM.
- Excluded: Parents who were not the primary care provider, had poor English proficiency, lacked internet or telephone access, and whose children had: a pre-existing diagnosis of AOM (<72 hours old); other concomitant diagnoses (pneumonia, urinary tract infection, gastroenteritis, sinusitis, or any other condition requiring antibiotics and/or hospital admission); tympanostomy tubes; acute tympanic membrane perforation.
- Intervention: Video discharge instructions
- Comparison: Paper-based discharge instructions identical to the video discharge instructions
- Primary Outcome: AOM Severity of Symptom (AOM-SOS) score on day three post-discharge.
- Secondary Outcomes: Knowledge questionnaire scores, parental satisfaction with the intervention, number of days of missed school or daycare (child) and work (parent), proportion of children with at least one return visit to a healthcare provider, and proportion of children who received analgesia.
This is an SGEMHOP episode which means we have the lead author on the show. Dr. Naveen Poonai is a Paediatric Emergency Medicine physician at the Children’s Hospital, London Health Sciences Centre, Associate Professor of Paediatrics and Internal Medicineat Western University, Canadian Association of Paediatric Health Centres (CAPHC) project lead for Paediatric Pain Assessment, and has a cross-appointment with the Department of Epidemiology and Biostatistics. He was previously on SGEM#177 discussing POCUS for diagnosing pediatric fractures.
This episode we are going to be talking about acute otitis media. There are a number of different guidelines out there for acute otitis media (Canadian Pediatric Society, American Academy of Pediatrics, American Association of Family Physicians, United Kingdom, and Australia) Naveen prefers the Canadian Pediatric Society guidelines.
Authors’ Conclusions: “Children of parents with AOM who watched a five-minute video in the ED detailing the identification and management of pain and fever experienced a clinically important and statistically significant decrease in symptomatology compared to a paper handout.”
Quality Checklist for Randomized Clinical Trials:
- The study population included or focused on those in the emergency department. Yes
- The study participants were adequately randomized. Yes
- The randomization process was concealed. Yes
- The participants were analyzed in the groups to which they were randomized. Yes
- The study participants were recruited consecutively (i.e. no selection bias). No
- The participants in both groups were similar with respect to prognostic factors. Unsure
- All participants were unaware of group allocation. No
- All groups were treated equally except for the intervention. Yes
- Follow-up was complete (i.e. at least 80% for both groups). No
- All patient-important outcomes were considered. Yes
- The treatment effect was large enough and precise enough to be clinically significant. Yes
Key Results: Overall, 5334 parents were screened for eligibility, 219 were randomized and analyzed and 149 completed the primary outcome (77 video; 72 paper instructions). Children included 107/219 (49%) females with an overall mean age of 2.9 years and 41/219 (18.7%) were not offered analgesia prior to arrival. There were no crossovers in the trial.
AOM-SOS score was significantly lower on day 3 in the video group
- Primary Outcome: AOM-SOS score on day three (0 to 14 with higher scores indicative of greater symptom severity)
- 1 video group vs. 3 paper group (p=0.004) even after adjusting for pre-intervention AOM-SOS and medication use (analgesics and antibiotics)
- Secondary Outcomes:
- There were no significant differences in secondary outcomes, including knowledge gain, functional outcomes or the number of children receiving antibiotics or analgesics following discharge.
1. Children:You included children age 6 months to 17 years of age. There is a big difference between an infant and a teenage. Why not just limit it to children under 5 years old? The mean age was 2.9 years with a SD of 2.8 years.
It is true that a young child is quite different from a teenager. We decided to cast a wide net to be more instead of less inclusive. Older children suffer from AOM as well and inclusion of these individuals extends the generalizability of our findings.
2. Diagnosis of AOM: The diagnosis of AOM can be a bit tricky. You included patients that the physician was 50% certain of a clinical diagnosis of AOM using a 100mm visual analog scale. That was based on color photos of AOM from published diagnostic criteria. Why not use a more objective criteria like tympanometry or acoustic reflectometry to increase diagnostic certainty?
In an ideal world we would have been able to use tympanometry or acoustic reflectometry, however these tools are unfortunately not available in our emergency department.
3. Convenience Sample: Recruitment was done seven days a week from 10am to 10pm. We understand the realities of conducting research and having someone available 24 hours a day. However, do you think parents that present overnight with sick children a different than those who present during the day?
It is possible that children that present in the middle of the night are experiencing more pain than those that present during daytime or evening hours. But is more likely that the pain they are experiencing is disruptive to their sleep and perhaps more so, their parents’ sleep. Parents that present with their child overnight may process discharge information quite differently from daytime hours.
4. Single Tertiary Pediatric Centre:This was a single centre study done at a pediatric emergency department. Do you think this data can be extrapolated to other pediatric emergency departments in Canada or internationally?
I think that this data can certainly be extrapolated to other Canadian pediatric emergency departments as other tertiary care pediatric centres are likely to have populations similar to ours. However further study would have to be undertaken to determine if the data would be applicable to international populations of differing languages and cultures. We excluded non-English speaking populations for feasibility purposes and so this study would have to be repeated including those speaking other languages to be able to confidently say the data apply more broadly.
In addition, I work in a rural community emergency department. We see adults and children. Do you think these results would apply to non-pediatric emergency departments?
I think these results would definitely apply to rural community emergency department pediatric patients of English speaking families.
5. Education Level: The parents in your study were well educated. More than 70% had at least a college education. How do think this could have impacted your results?
I think this may have contributed to the reason we saw no difference in knowledge acquisition between groups. If we had demonstrated greater knowledge acquisition in the video group, we may have postulated that the significant difference in symptomatology between groups could be related to great knowledge acquisition and therefore more appropriate care of the children randomized to the video group.
6. Health Literacy: You used a grade 8 level for literacy. Less than 5% of your population reported elementary school only. I conducted some research looking at rural populations and found 40% of adults attending a number of rural emergency departments had limited health literacy defined as below Grade 9 level. This has me concerned that the video and paper discharge instructions may not be understandable to a significant part of rural emergency department patients.
This is a valid concern. I would wonder what is provided for discharge instructions in these rural emergency departments. It may be possible that much like many emergency departments almost 30% of patients with AOM are not provided any instruction on pain management and potentially providing a video even if it is slightly above the educational level of individual, it may be better than what is currently done. The best-case scenario would be to develop a video targeting caregiver with minimal or no education.
7. Exclusion of Non-English: You screened over 5,300 patients and almost 5,000 did not meet inclusion criteria. How many were because of non-English speaking parents? Did they have different demographics than the English-speaking parents? If they had lower health literacy, this cohort could be the group to benefit more from improved discharge instructions than English speaking highly educated parents.
The vast majority of patients screened were excluded because they did not have a diagnosis of AOM. A small percentage were excluded because of non-English speaking parents. However, we didn’t collect demographic data on non-eligible patients.
8. AOM-SOS Score: Could you explain this score to the SGEMers? You state that it has been validated and provide a reference (Hoberman et al NEJM 2011). This study was done in children under the age of two years. Your mean age was 2.9 years. Has the AOM-SOS score been validated in children over the age of two years?
The acute otitis media severity of symptoms score is a 7-question survey that assesses the child’s symptoms over the last 24 hours as reported by the caregiver, thereby reflecting their perception of the child’s symptomatology. A score of 0 reflects no symptoms and a score of 13 reflects maximal symptoms. The questions enquire about things such as crying, ability to sleep, appetite, activity level.
The AOM SOS has been validated for use in children two years and under. So, a noteworthy limitation of our study is that we extrapolated the use of this tool to older children. However, the AOM-SOS was the best tool we had given there is no tool validated for use in older children.
You state in the conclusions that this is both a statistically significant and a clinically significant change in AOM-SOS scores on day three. However, if patients were just eating a less on day three, the scores would be one versus two in the groups. Would this really be a clinically significant impact?
I would argue that a difference in any one of the AOM-SOS survey questions is a clinically significant change given the impact these of these behavioural changes on the family, the level of stress experienced by the caregiver and the comfort of the child.
You had the parents complete the AOM-SOS Score only on the first three days with the primary outcome being the score at day three. Why did you pick day three and why not score for the duration of the suggested length of treatment, five to ten days?
We chose day three as our primary outcome because the AOM symptomatology generally undergoes the greatest change over the first three days of illness.
Additionally, one of the biggest challenges with conducting studies such as this is loss to follow up – we anticipated loss to follow up would be too great if we attempted to follow participants for longer than three days.
9. Loss to Follow-up. We typically like to see at least 80% of patients included in the analysis. In other words, less than 20% loss to follow-up. You anticipated a high loss to follow-up in your power calculation and were correct with only 68% of patients in the trial completed the primary outcome (follow-up at 3 days). How do you think losing 1/3 of patients could impact the results and their interpretation?
Well it’s entirely possible that parents who followed up were more satisfied with their care and may have been more likely to report lower symptoms scores, biasing us away from the null hypothesis.
10. Gift Card: You offered parents a $5 gift card as compensation for study participation. Both Chris and I were wondering if this was a Tim Horton’s Card?
They were actually Starbucks (greater flexibility of emailing gift cards).
Is there anything else you want to say about your HOP publication?
Sure. The findings of this study indirectly speak to the need to address children’s pain both in the ED and post-discharge. We’ve done our best to translate what is already known about the distress of AOM into what we hope is practice-changing discharge instructions.
Comment on Authors’ Conclusion Compared to SGEM Conclusion: We generally agree with the authors’ conclusions and would add in this single tertiary pediatric emergency department.
SGEM Bottom Line: Consider using video discharge instructions for parents of children with acute otitis media.
Case Resolution: After a brief discussion with the parent, you have them watch a video of discharge instructions for their child. You then return and answer their questions prior to discharge.
Clinical Application: This study provides support for use of video discharge instructions for AOM.
What Do I Tell the Parents? Your child has an ear infection. It has been shown that your child’s pain and symptoms will be better managed 3 days after discharge if we have you watch a 5-minute video about ear infection treatment before you leave. We’ll also give the video link so you can watch it again at home and I’ll answer any questions you have after watching prior to your discharge.
Keener Kontest: We had two questions from the live show at Kawartha Emergency Medicine Conference (KEMC) in Peterborough. Many people knew the answer and I gave some prizes out at the conference. The answer is the radiation dose from a CTPA to the maternal breast can increase the risk of breast cancer for a 25-year-old woman by 1.5%.
The other question was mcuh harder. The question, who is the most famous Peterborough Pete to go on and have the most NHL success? The key to getting this question correct is that it did not need to be a player. Rachel Vanderheyden got the answer correct, Scotty Bowman. “He has the most wins in NHL history (1,244 in the regular season, 223 in the playoffs) and has 13 Stanley Cup rings (nine of which as coach).”
Listen to the podcast to hear this weeks’ trivia question. If you know the answer, send an email to TheSGEM@gmail.com with “keener” in the subject line. The first correct answer will receive a cool skeptical prize.
SGEMHOP: Now it is your turn SGEMers. What do you think of this episode on video discharge instructions for AOM? Tweet your comments using #SGEMHOP. What questions do you have for Sheena, Naveen and their team? Ask them on the SGEM blog. The best social media feedback will be published in AEM.
Also, don’t forget those of you who are subscribers to Academic Emergency Medicine can head over to the AEM home page to get CME credit for this podcast and article. We will put the process on the SGEM blog:
- Go to the Wiley Health Learning website
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- Search for Academic Emergency Medicine – “December”
- Complete the five questions and submit your answers
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Remember to be skeptical of anything you learn, even if you heard it on the Skeptics’ Guide to Emergency Medicine.
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