Article, Otolaryngology

Comparison of traditional otoscope to iPhone otoscope in the pediatric ED

a b s t r a c t

Objective: acute otitis media (AOM) isa common diagnosis under age5 years. The primary objective was to deter- mine if the CellScope Oto (CSO) improves tympanic membrane (TM) visualization and diagnostic precision compared to traditional otoscope. The secondary objective was to determine physician, patient, and parent device preference. Methods: This is a prospective cross-sectional study of patients younger than 18 years presenting with ear pain, fever, or upper respiratory infection symptoms. Patients were examined by a resident then attending physician with a tra- ditional wall-mounted otoscope followed by CSO. Each was blinded to the other’s findings. Intrarater and interrater diagnostic agreement was compared. Physicians, parents, and patients were surveyed regarding their experience. Results: A total of 51 patients completed the study. There was substantial intrarater agreement between traditional otoscope and CSO for residents: right ear (? = 0.74) and left ear (? = 0.74); CSO use changed reported view for 16 of 102 TM examinations (16%), of which 7 (7%) had clinically relevant change in diagnosis to/from AOM. There was substantial to almost-perfect agreement for attending physicians: right: (? = 0.86) and left (? = 0.79); CSO use changed reported view for 12 (12%), with 6 (6%) clinically relevant. Resident/attending physician interrater agree- ment was moderate for both traditional otoscope (? = 0.40) and CSO (? = 0.47). Physicians agreed CSO was easy to use, enhanced TM visualization and diagnostic precision, and was a good teaching tool. Patients and parents also found the CSO images very helpful.

Conclusion: CellScope Oto was preferred by physicians, patients, and parents. Use of the CSO changed final diagnosis a significant number of times, including clinically relevant changes to/from AOM.

(C) 2015

Introduction

Background

It is estimated that most children in the United States and worldwide will experience acute otitis media (AOM) at least once before the age of 2 years [1]. Acute otitis media is the most common presentation for medical therapy under the age of 5 years and represents the most common reason that antibiotics are prescribed [2]. However, in an era of increasing antibiotic resistance, accurate diagnosis of AOM is essen- tial. The total Financial burden to society is significant when considering the number of diagnoses of AOM per year, antibiotic and over-the- counter medication costs, clinic visits, and missed work. A recent study reported annual costs of $314 per child with a total of $2.88 billion in the United States alone [3]. There is also the inconvenience of lost school and work hours, as both children and their parents often must stay at home.

? Presented at the Society for Academic Medicine Annual Meeting, San Diego, CA, May 15, 2015.

* Corresponding author at: Department of Emergency Medicine, PSSB 2100, UC Davis Medical Center, 2315 Stockton Boulevard, Sacramento, CA 95817. Tel.: +1 916 734

1537; fax: +1 916 734 7950.

E-mail address: [email protected] (J.R. Richards).

Importance

The diagnosis of AOM is entirely visual. Any device that can improve the visualization of the tympanic membrane (TM) and provide magnifi- cation and storage of images would certainly impact diagnostic preci- sion. Being able to show parent and patient the images would likely improve satisfaction. The potential for parental home use and transmis- sion of images to the patient’s physician for further review is yet another advantage [4]. This method of patient care may also aid physicians in discussing treatment, such as “watch-and-wait” vs antibiotics, as most uncomplicated AOM are self-resolving [5]. Excessive prescriptions for antibiotics increase costs, risk Adverse drug reactions, and promote rel- ative and absolute resistance to antibiotics. Such a tool could also be helpful for teaching medical students and residents.

Goals of this investigation

The goal of this prospective study was to determine if an iPhone at- tachment, the CellScope Oto (CSO) (Cellscope, Inc, San Francisco, CA), improves visualization of the TM and precision in the diagnosis of pedi- atric otologic disease when compared to the traditional otoscope. We also aimed to determine if physicians, patients, and parents preferred the CSO due to its ease of use, enhanced Image quality, ability to capture video, and use as a teaching tool.

http://dx.doi.org/10.1016/j.ajem.2015.04.063

0735-6757/(C) 2015

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Inter-rater

Intra-rater

Figure. Data collection form (physician 1: resident), (physician 2: attending physician), and agreement analysis.

Methods

Study design and setting

This was a prospective cross-sectional study conducted from August to November 2014 in an academic pediatric emergency department (ED) serving an urban community of 2 million. A convenience sample of eligible patients was identified when a research associate was present (7 days a week from 5 AM to 12 AM). Verbal consent was obtained from the child if age appropriate, and written informed consent was obtained from the parent or guardian. This study was approved by the hospital’s institutional review board.

Selection of participants

Participating study physicians were residents and attending fac- ulty members who routinely performed ear examinations using the traditional wall-mounted otoscope and who had never used the CSO before commencement of the study. Participation in the study was voluntary. Pediatric Patients 17 years or younger presenting to the ED complaining of ear pain, fever, or upper respiratory symp- toms were eligible for enrollment.

Interventions

There was no specific training given to the physician participants on use of the CSO. A dedicated iPhone and CSO attachment was available for purposes of the study. Patients were examined by a resident then by an attending physician. Both physicians performed the ear examina- tion first with a traditional wall-mounted otoscope, followed by the CSO. No verbal diagnostic impressions were shared between resident, attending physician, and patient until all examinations were completed. Recorded images from the CSO examination were then shown to the parent and patient.

Methods and measurements

The resident and attending physicians’ examination findings for both the traditional otoscope and then CSO were recorded sequentially on separate data cards (Figure). “Other not listed” represented

conditions not defined by “erythema” or “effusion,” such as foreign body, myringitis, cholesteotoma, or tympanosclerosis. Parents or pa- tients were surveyed after both the resident and attending physician ex- aminations. Each physician was blinded to the other’s findings until all examinations were completed and data were recorded. The visual diag- nostic impressions were then shared and discussed between the resi- dent and attending participants to determine appropriate therapy and disposition. This information was then shared with the parent and child (if age appropriate). Patient demographics and physicians’ years of experience were also recorded. The physicians then completed a sur- vey regarding their experience with both devices.

Outcomes

The ear examination findings were grouped as normal; abnormal with effusion, abnormal with erythema of TM, abnormal (other not listed); cerumen impaction; and unable to visualize. For the parental (or patient) survey, a 5-point Likert scale was used with 1, not helpful at all; 2, not very helpful; 3, undecided; 4, helpful; and 5, very helpful. This survey had 1 question: “How helpful were the images from the CellScope exam to you?” The physician survey had 4 questions and also used a 5-point Likert scale with 1, strongly disagree; 2, disagree; 3, undecided; 4, agree; and 5, strongly agree. There were 4 questions: “I found the CellScope very easy to use,” “I believe the CellScope will help me more precisely diagnose AOM,” “I found the CellScope images to be very good,” and “I think CellScope would be a good teaching tool.”

Analysis

Using ? statistics, we compared intrarater and interrater diagnostic agreement with 95% confidence intervals (CIs). ? values between 0 and 0.2 corresponded to slight agreement; between 0.21 and 0.40, fair agreement; between 0.41 and 0.60, moderate agreement; between

0.61 and 0.80, substantial agreement; and between 0.81 and 1.0, almost perfect agreement. For the survey questions, paired nonparametric re- sults were reported as median with interquartile range (IQR) and ana- lyzed with Wilcoxon Signed Rank Test. Significance was assumed at a level of P b .05. Data were analyzed with InStat (GraphPad, La Jolla, CA).

J.R. Richards et al. / American Journal of Emergency Medicine 33 (2015) 10891092 1091

Table 2

Resident and attending physician responses and comparison regarding use of the CSO

?Wilcoxon rank sum test.

Results

Characteristics of study subjects

A total of 54 patients were enrolled, and 51 completed the study. Two patients did not complete the study because they would not re- main still for both physicians’ examinations, and 1 patient had incom- plete data. Average age was 5.1 +- 3.7 years with 47% females and 53% males. Resident physicians had a mean and SD of 2.0 +- 0.9 years of ex- perience, and attending physicians had 10.5 +- 7.1 years.

Main results

There was substantial intrarater agreement between traditional oto- scope and CSO for resident physicians: 43 (84%) of 51 for the right ear (?

= 0.74; 95% CI, 0.58-0.89) and 43 (84%) of 51 for the left ear (? = 0.74; 95% CI, 0.58-0.89). The residents’ use of the CSO after traditional oto- scope changed the reported view of the TM for 16 (16%) of 102 exami- nations, of which 7 (7%) had a clinically relevant change in diagnosis (Table 1). For residents, the TM was unable to be visualized in 8 exam- inations (8%). Clinical relevance was defined as any change in diagnosis

Table 1

Change in visualization of the TM after CSO use

Residents Attending physicians

Normal to unable to visualize 7 5

Normal to erythemaa 3 0

Normal to cerumen impaction 1 0

Effusion to normala 2 0

Erythema to normala 0 1

Erythema to effusiona 0 1

Other to unable to visualize 1 1

Unable to visualize to erythemaa 0 3

Unable to visualize to othera 2 1

Total 16 12

a Clinically significant change in diagnosis.

that could potentially lead to inclusion or exclusion of antibiotics in the patient’s treatment plan.

There was substantial to almost-perfect intrarater agreement for at- tending physicians: 47 (92%) of 51 for the right ear (? = 0.86; 95% CI,

0.72-0.98) and 45 of 51 for the left ear (? = 0.79; 95% CI, 0.65-0.94). The attending physicians’ use of the CSO changed the reported view of the TM for 12 (12%) of 102 examinations, of which 6 (6%) were clinically relevant (Table 1). For attending physicians, the TM was unable to be vi- sualized in 6 examinations (6%). Interrater agreement between resident and attending physicians for both ears was moderate: 68 (67%) of 102 for the traditional otoscope (? = 0.40; 95% CI, 0.25-0.55) and 69 (68%) of 102 for the CSO (? = 0.47; 95% CI, 0.33-0.61).

Both resident and attending physicians overwhelmingly agreed that CSO was easy to use, enabled more precise diagnosis, enhanced TM vi- sualization, and was a good teaching tool (Table 2). Patients and parents also found the CSO images very helpful, with 47 parents (92%) and 4 children (8%) responding. For the resident physician examination, me- dian score was 5 with an IQR of 4 to 5. For the attending physician exam- ination, median score was 5 with an IQR of 4 to 5.

Limitations

There are several potential limitations with our study. The first is that the subjects were a convenience sample enrolled during a certain period of the day. There was no randomization of patients, and blinding of the physician, parent, and child to the instrument being used would have been difficult to impossible. To avoid bias from past experience with the CSO, no physicians had experience with the CSO before the study. To keep the experience with the CSO as uniform as possible, there was no formal training in its use. Some physicians provided feed- back to the authors that the CSO was awkward to hold and capture im- ages simultaneously and that they were unsure of how to adjust the light intensity. This may explain several instances of reported “unable to visualize” the TM with the CSO in our study. With formal prior train- ing, physicians’ failure to visualize the TM, agreement, and satisfaction may have been affected, most likely in a positive manner.

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Another potential limitation is that the diagnosis of AOM is visual and subjective. The initial examination with the traditional otoscope may have influenced the subsequent CSO examination from anchoring bias. This could lead to a falsely elevated intrarater agreement. Finally, we did not include the change in diagnosis from “normal” or “other” to “unable to visualize” as clinically relevant. We designated erythema as a diagnostic choice but did not include the finding of concomitant ef- fusion. Erythema without effusion may not justify the prescription of antibiotics for many clinicians and thus may not uniformly be consid- ered clinically relevant for the purpose of this study.

Discussion

As of time of writing, we believe that this study represents the first prospective clinical trial of a smartphone attachment available to clini- cians and parents to enhance visualization of the TM. Prior studies have evaluated specialized equipment for improving TM visualization: otomicroscopes, video pneumatic otoscopes, acoustic reflectometers, optoelectronic holographic otoscopes, fiberoptic teleotoscopes, sound- generating otoscopes, interferometric otoscopes, and multiwavelength fluorescence otoscopes [6-9]. This equipment is expensive, requires technical expertise, and is not readily available in the primary care clin- ic, ED, or home. The CSO is currently available for purchase by physi- cians and patients. We anticipate that mobile-enhanced technologies such as CSO will continue to be developed for clinical applications and widespread use.

The criterion standard for AOM diagnosis remains direct visualiza- tion of the TM. The traditional otoscope enables a brief view of the TM in pediatric patients unable to hold still. The CSO represents an advan- tage in this patient population, as it enables video and/or images to be taken and reviewed using magnification if desired. These patients may not cooperate with the examining clinician but may for the parent. Thus, the ability of the parent to use this device represents another ad- vantage. These digital recordings may be sent electronically for further clinical review, either by the parent or Primary care clinician to the spe- cialist. In our study, there were 13 examinations in which the TM was unable to be visualized with the CSO by clinicians. We believe that this emphasizes the need for Training and practice with a new device and for having a back-up traditional otoscope.

Assuming responsible home use by informed parents and patients, these devices may improve patient-physician communication, under- standing of disease and treatment options, and ultimately satisfaction. These devices may also decrease unnecessary and costly trips to the clinic or ED. Diagnosis through teleotology has been shown to be accu- rate [10]. Parents are becoming more aware that common antibiotics are less effective in the treatment of AOM from the rise in antibiotic re- sistance. The implementation of a watch-and-wait strategy before giv- ing antibiotics to children with AOM remains challenging in all but a few countries [5]. However, home use of the CSO with or without phy- sician input may help change parents’ attitude toward watch-and-wait and prescribing of unnecessary antibiotics.

In our study, the physician participants agreed that the CSO was a useful teaching tool. Several studies have identified deficiencies in otoscopic diagnostic skills in residents and medical students [6]. The au- thors of a study of interrater agreement between pediatric residents and

pediatric otolaryngologists reported a ? = 0.30 or fair agreement [11]. In our study, there was moderate agreement between residents and at- tending physicians for both the traditional otoscope and CSO (? =

.0.40 and 0.47, respectively). These skills have been taught primarily by repetitive examinations accompanied by didactic sessions and referencing still images of TMs. The replacement or supplementation of the traditional otoscope with a smartphone-enabled Digital otoscope should theoretically improve medical education of otoscopy skill and in- terpretation. These improved diagnostic skills will undoubtedly lead to reduced future prescribing of unnecessary antibiotics. Further studies are needed to assess this technology, such as comparing the interrater reliability of residents to attending physicians using traditional otoscopy, then comparing residents using CSO to attending physicians using the traditional method. The inclusion of parents as examiners rep- resents another potential future study.

In summary, CSO was preferred by resident and attending physi- cians for ease of use, improving view of the TM, enabling a more precise diagnosis, and utility as a teaching aid. Parents and patients felt that the CSO was very helpful, especially the ability to see real-time images of the TM examination. Use of the CSO changed final diagnosis a significant number of times, including clinically relevant changes to/from AOM, which may have directly influenced the decision to prescribe antibiotics. There were instances of physicians being unable to visualize the TM with the CSO. As with any new medical device, training, familiarization, and repetitive use of the CSO would likely ameliorate this. We believe that further prospective studies of this device are warranted, including comparison to other existing devices and telemedicine diagnosis of AOM from parental use at home.

The authors (JRR, KAG, and AJP) certify that they have no affiliations with or involvement in any organization or entity with any financial in- terest (such as honoraria; educational grants; participation in speakers’ bureaus; membership, employment, consultancies, stock ownership, or other equity interest; and expert testimony or patent licensing arrange- ments) or nonfinancial interest (such as personal or professional rela- tionships, affiliations, knowledge, or beliefs) in the subject matter or materials discussed in this article.

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