Abstract
Chronic Otitis Media (COM) is a major indication for tympanoplasty. It is important to predict the outcome of surgery and give proper counselling for the patient. This avoids untoward expectations. To measure the outcome of patients who underwent tympanoplasty for mucosal type of chronic otitis media (COM) using Middle ear risk index (MERI) score. Any possible correlation of MERI score with outcomes? Assess quality-of-life. Prospective analytical comparative cohort study. Sample size was 75. All patients underwent tympanoplasty for mucosal type of COM with hearing loss. The patients were categorised into mild, moderate and severe groups based on the MERI score. The hearing benefit was calculated from the pre- and post-op difference in PTA. The graft uptake status was graded. The relation between MERI score, graft status and hearing benefit were analysed and compared. QOL was assessed by COMOT-15 questionnaire. Patients with a high MERI score had lower rate of graft uptake, whereas, patients with mild MERI had greater hearing benefit and those with severe MERI had lesser hearing benefit postoperative. MERI score is a prognostic tool to predict the outcome of tympanoplasty. It has an inverse relation with graft uptake and hearing benefit. Based on MERI score, the chances for surgical success and hearing benefit could be explained to the patient to give them realistic expectations.
Keywords: Middle Ear Risk Index (MERI) score, Tympanoplasty, Hearing benefit, Graft uptake, Pure-tone audiometry (PTA), Chronic otitis media (COM), Tubo-tympanic, Quality-of-life, Questionnaire, COMOT-15
Introduction
Chronic Otitis Media (COM) is defined as a long standing irreversible inflammation of mucoperiostial lining of the middle ear cleft resulting in changes in the tympanic membrane [1]. It is prevalent in about 65–330 million people around the world with 60% of them suffering from significant hearing loss [2]. Adoga et al. [3] stated that of all the complications associated with COM, hearing loss is nearly always significant. The Prevalence of hearing loss complicating COM has been reported to be 9–83% [3–5]. Tympanic membrane perforation associated with COM has been considered as the major indication for tympanoplasty [6–14].
Bellucci suggested four discrete stages of prognosis based on the status of the ear discharge at presentation [15]. Black introduced the Surgical, Prosthetic, Infection, Tissues, and Eustachian tube (SPITE) system [16]. Wullstein [17] and Austin [18] developed a system that included the residual ossicular remnants. Kartush had divided these into intrinsic/extrinsic factors [18]. The Middle Ear Risk Index (MERI) was developed by Becvarovski and Kartush [19]. It was used to assess the severity of the disease by assigning specific value to each risk factor and the total sum (max score = 12) gives the MERI score, revised in 2001 [12, 19].
Becvarovski and Kartush summarised their results based on otoscopic findings only i.e., uptake or rejection of graft. But in our study, we additionally evaluated the functional outcome (hearing benefit) by preoperative and postoperative Puretone Audiometry(PTA) findings. It was important to predict the outcome of surgery and give proper counselling for the patient. This likely avoids unrealistic expectations from the patient’s perspective.
Aims and Objectives
To measure the outcome of patients who underwent tympanoplasty for mucosal type of chronic otitis media (COM) using Middle ear risk index (MERI) score. Any possible correlation of MERI score? Assess quality-of-life.
Materials and Methods
This prospective cohort comparative study was conducted in the Department of Otorhinolaryngology, at a tertiary health care centre from March 2018 to December 2019. We observed the outcomes of tympanoplasty ± cortical mastoidectomy in terms of graft uptake and improvement of hearing with the MERI score. The study was approved by the Institutional Review Board and Ethics Committee–SMC/IEC/2018/03/026. All patients were explained about the study and written informed consent was obtained prior to participation.
Inclusion Criteria
Unilateral COM—mucosal type, inactive stage.
Aged between 20 and 50 years.
Adequate cochlear reserve.
Exclusion Criteria
Sensorineural hearing loss and mixed hearing loss.
Uncontrolled co-morbidities.
Squamous type ear disease/other active septic foci.
No previous surgery/Complications of COM.
Patients who met the criteria (82) underwent pre-operative oto-microscopic examination, High-resolution Computed Tomography (HRCT) of temporal bones and PTA recorded at 500, 1000, 2000 and 4000 Hz. MERI score was calculated and patients were grouped as MERI I/II/III. A power calculation showed that a sample size of 82 patients would achieve a power of 90%. Medical and general anesthesia(GA) fitness was obtained. Patients who enrolled were requested to fill the quality-of-life(QOL) questionnaire Chronic Otitis Media Outcome test-15 (COMOT-15) [20] pre-operatively and at 6 months post-operatively(with vernacular support/translator/fill by proxy). It was administered according to the original procedure recommended by Baumann et al. [20]. Those patients who were lost on follow-up (at 6 months) were contacted over telephone and response recorded by the secretary.
All surgeries were done under GA by the same surgeon to avoid skill bias. Type of procedure was decided pre-operatively. Modification was done based on the intra-operative findings. Temporalis fascia graft by underlay technique was done for all patients. Post-operative period was uneventful. Patients were on parenteral cefotaxime and diclofenac for 3 days, followed by oral antibiotics and anti–inflammatory analgesic for 4 days. All the patients were on similar daily post-operative care and diet. Patients were discharged after suture removal on 7th post-operative day.
All patients had otomicroscopic examination at the end of 1 month post-operatively for analysis of neo-tympanum. PTA was repeated post-operatively at the end of 1, 3 and 6 months. Otomicroscopic findings were graded as good neotympanum, presence of retraction or reperforation [21]. IBM-SPSS v22[SPSS Inc., Chicago, Illinois] was used. p value < 0.05 was considered statistically significant. Data were represented as mean ± standard deviation (continuous data); numbers, percentage (categorical data); paired t-test; unpaired t test; Pearson correlation were worked out.
Results and Discussion
Demographic data and MERI score-graft status are represented in Tables 1 and 2. 75(n) patients complied with the study protocol, tolerated the surgical procedure and completed 3 follow-ups. Drop-outs (7, 8.5%) at 1 month post-op were excluded from the study. The overall graft uptake rate was 92% (n = 69) with 8% (n = 6) having re-perforation (failure rate). All reperforations were small central perforation in anterior segment noted by 2–3 weeks post-operatively in MERI III category—the upside being that the patients were counselled prior with this outcome and forthcoming for further treatment. With nasal decongestion, they were planned for chemical cauterisation. Further recovery was uneventful.
Table 1.
MERI score and graft status
| Parameters | TM uptake grade | Total | ||
|---|---|---|---|---|
| MERI grade | I (take up well) | II (retraction) | III (reperforation) | |
| 1–3 Mild | 28 | 1 | 0 | 29 |
| 4–6 Moderate | 12 | 5 | 0 | 17 |
| 7–12 Severe | 16 | 7 | 6 | 29 |
| Total | 56 | 13 | 6 | 75 |
Table 2.
Demographic data
| Parameter | Values |
|---|---|
| Male: female | 1: 1.68 |
| Age range (years) | 20–50 |
| Mean age (years) | 33.12 ± 8.1 |
| Age distribution (years) | |
| 21–30 | 21 (28%) |
| 31–40 | 34 (45%) |
| 41–50 | 20 (27%) |
| Middle Ear Risk Index (MERI)—n (%) | |
| Mild (1–3) | 29 (38.7%) |
| Moderate (4–6) | 17 (22.6%) |
| Severe (7–12) | 29 (38.7%) |
| Tympanoplasty type ± cortical mastoidectomy | |
| Type 1 | 27 (36%) |
| Type 2 | 39 (52%) |
| Type 3 | 9 (12%) |
| Drop-out rate | 8.5% (n = 7) |
| Overall graft uptake | 92% (n = 69) |
| Failure rate | 8% (n = 6) |
| Mean duration of disease (COM) | 6.07 ± 4.83 |
6 month post-op PTA values of all MERI groups were analysed by unpaired t-test to check for statistical significance (Table 3). Individual mean PTA values at 0 month (pre-op), 1, 3 and 6 month for MERI I were denoted as i0, i1, i3 and i6; for MERI II—ii0, ii1, ii3 and ii6; for MERI III—iii0, iii1, iii3 and iii6; Overall mean PTA values for the MERI groups were denoted as a0, a1, a3 and a6 respectively. Pair comparisons were depicted likewise for ease of statistical tabulation (Table 4).
Table 3.
MERI groups unpaired t test
| Parameter | n | Post-op PTA 6 month | p value |
|---|---|---|---|
| Unpaired sample t test values | |||
| MERI I/II | 29/17 | 18.86 ± 4.23 versus 31.03 ± 2.94 | 0.001 |
| MERI II/III | 17/29 | 31.03 ± 2.94 versus 49.05 ± 6.73 | |
| MERI I/III | 29/29 | 18.86 ± 4.23 versus 49.05 ± 6.73 | |
Bold vaue represents the statistical significance
Table 4.
Individual MERI Group and overall statistics
| Parameter | MERI I n | Pre-op PTA (i0) | Post-op PTA 1 month (i1) | Post-op PTA 3 month (i3) | Post-op PTA 6 month (i6) | |
|---|---|---|---|---|---|---|
| Paired sample t test values—paired differences | ||||||
| MERI I | 29 | 30.48 ± 3.24 | 29.52 ± 3.81 | 20.45 ± 4.17 | 18.86 ± 4.23 | |
| Pairs | i0–i1 | i0–i3 | i0–i6 | i1–i3 | i1–i6 | i3–i6 |
| p value | 0.001 | 0.001 | 0.001 | 0.001 | 0.001 | 0.001 |
| Parameter | MERI II n | Pre-op PTA (ii0) | Post-op PTA 1 month (ii1) | Post-op PTA 3 month (ii3) | Post-op PTA 6 month (ii6) | |
|---|---|---|---|---|---|---|
| MERI II | 17 | 38.47 ± 2.62 | 35.94 ± 1.85 | 33.35 ± 1.80 | 31.03 ± 2.94 | |
| Pairs | ii0–ii1 | ii0–ii3 | ii0–ii6 | ii1–ii3 | ii1–ii6 | ii3–ii6 |
| p value | 0.001 | 0.001 | 0.001 | 0.001 | 0.001 | 0.001 |
| Parameter | MERI III n | Pre-op PTA (iii0) | Post-op PTA 1 month (iii1) | Post-op PTA 3 month (iii3) | Post-op PTA 6 month (iii6) | |
|---|---|---|---|---|---|---|
| MERI III | 29 | 49.31 ± 7.16 | 49.07 ± 6.76 | 49.03 ± 6.78 | 49.05 ± 6.73 | |
| Pairs | iii0–iii1 | iii0–iii3 | iii0–iii6 | iii1–iii6 | iii3–iii6 | |
| p value | 0.047 | 0.047 | 0.043 | – | 0.326 | 0.331 |
| Parameter | Total n | Pre-op PTA (a0) | Post-op PTA 1 month (a1) | Post-op PTA 3 month (a3) | Post-op PTA 6 month (a6) | |
|---|---|---|---|---|---|---|
| MERI I-III | 75 | 39.57 ± 9.73 | 37.81 ± 9.53 | 33.03 ± 4.25 | 31.06 ± 6.91 | |
| Pairs | a0–a1 | a0–a3 | a0–a6 | a1–a3 | a1–a6 | a3–a6 |
| p value | 0.001 | 0.001 | 0.001 | 0.001 | 0.001 | 0.001 |
COM is a very common Otorhinolaryngeal problem worldwide. Around 7.8% of the Indians suffer from this infection according to WHO report, 2004 [2]. Inspite of the availability of wide range of antibiotics, better surgical techniques and newly developed prosthetic materials we are still not able to reach 100% successful outcomes in tympanoplasty in terms of graft uptake and hearing benefit. The extent of pathology in the middle ear and mastoid may affect the outcome. It was preferable to make the ear dry preoperatively to achieve best results [22–24].
MERI was scored and candidates were grouped into MERI I/II/III (Table 1). Age range was 20–50 years, with mean age at 33.12 ± 8.1 years. Shrikrishna et al. [25] showed that mucosal type of COM was common in the age group of 10–40 years. This was in comparison with our study with the most common age group affected being 31–40 years (45%) followed by 21–30 years (28%). 73% of our study group belonged to 20–40 years of age. Mean duration of disease was 6.07 ± 4.83 years (Table 2, Fig. 1).
Fig. 1.
Duration of disease (COM)
In our study, female preponderance was noted as also in a study by Bijan Basak et al. [26]. However, Abhinav et al. [27] studied that the disease was more common in males. High volume industrial and immigrant labour in and around our hospital, possible lack of proper nutrition and reduced literacy rate (and hence poor hygienic practices) among females might contribute to higher incidence. Dropout rate was 8.5% (n = 7).
According to Mohammadi et al. [28], incus was the most commonly eroded ossicle. In our study, ossicular erosion was documented to be the long process of the incus(48.64%), malleus handle(21.28%) and stapes suprastructure(9.12%) according to which type of tympanoplasty was done (Table 2).
Studies by Veysel et al. [29], Ars et al. [30] and Da Costa et al. [31] documented factors which adversely affected outcome. Studies [19] also documented that smoking either resulted in delayed failure/reduced graft uptake or higher frequency of failure. In our study, 4 of 6 who had initial graft failure were smokers(66.7%-MERI III, Table 1, 2). Temporalis fascia graft was used for all candidates but other studies give varying opinion [32–34].
Success rate with reference to graft uptake status was 92% (n = 69, Table 1, 2). Graft uptake rate was 76% in patients who underwent tympanoplasty and 88% in tympanoplasty with cortical mastoidectomy [35]. But Andersen et al. [36] showed that graft uptake rate after type 1 tympanoplasty was 86.6%.
Success rate with reference to hearing benefit was depicted in Tables 3,4. Unpaired t test (Table 3) between the MERI groups also showed statistical significance (Table 3). Lower MERI score definitely fared better than higher MERI scores. Viktor Chrobok et al. [37] showed that patients with a generally lower MERI had better pre-op and post-op air and bone conduction than patients with a higher MERI score. They concluded that cholesteatoma, tympanic membrane perforation, status of the ossicular chain, history of previous surgery and the overall sum of the MERI were highly significant pre-operative negative prognostic factors influencing the outcome of tympanoplasty. In this study, similar outcomes were recorded; patients with higher MERI scores had higher graft rejection rates.
Paired sample t test (Table 4) on mean PTA showed good statistical significance (p < 0.001) for individual MERI I, MERI II groups as well as overall pre-op and post-op values and comparable to study by Siddharth et al. [38]. However, the values for MERI III group were just significant at 0.047 (1 m), 0.047 (3 m) and 0.043 (6 m) when compared to pre-op (0 m). This showed that all categories definitely benefit from the procedure but MERI III was statistically lagging.
Harikrishnan et al. [39] concluded that preoperative audiological evaluation was necessary to assess the prognosis and also for medicolegal point of view along with regular follow-up. We followed up the patients for a maximum period of 1 year.
Pearson’s correlation co-efficient values between Pre-op PTA and MERI category were 0.896 (MERI I), 0.808 (MERI II), 0.936 (MERI III) and overall category was 0.969 showing positive correlation (Fig. 2). This showed positive correlation between MERI score and PTA values hinting at use of MERI as a tool to predict severity of hearing loss.
Fig. 2.
Correlation between overall MERI-PTA
The mean COMOT-15 values (Table 5) for all MERI groups suggested deterioration of health-related QOL in patients with COM. The mean subscale values further highlighted that hearing function was an important determinant of QOL across MERI groups. The overall 6 month values showed a statistical significance (p < 0.05). In MERI I & II all subscales were good. However, in MERI III, hearing function p value was 0.79 (not statistically significant) and mental health p value was 0.04 which was weak compared to other groups. It could also be seen from the table that mean values were higher for higher grade of MERI. The improvement in QOL definitely can be judged as MERI I > MERI II > MERI III. Similar consensus was arrived at another study [21].
Table 5.
Chronic otitis media outcome test—15 scale
| Parameter | Pre-op score | Post-op 6 month score | p value |
|---|---|---|---|
| Chronic otitis media outcome test—15 (COMOT-15) scale | |||
| MERI I | |||
| Ear symptoms (ES) | 34.1 ± 16.9 | 26.5 ± 15.6 | 0.01 |
| Hearing Function (HF) | 59.2 ± 19.4 | 48.7 ± 18.5 | |
| Mental Health (MH) | 45.8 ± 18.6 | 38.4 ± 18.6 | |
| Overall score (OS) | 45.3 ± 16.7 | 37.2 ± 17.4 | |
| MERI II | |||
| Ear symptoms (ES) | 37.2 ± 17.3 | 29.1 ± 17.8 | 0.01 |
| Hearing Function (HF) | 64.3 ± 20.5 | 57.7 ± 21.2 | 0.03 |
| Mental Health (MH) | 46.9 ± 22.3 | 35.4 ± 19.9 | 0.01 |
| Overall score (OS) | 48.2 ± 17.8 | 39.5 ± 19.6 | 0.01 |
| MERI III | |||
| Ear symptoms (ES) | 38.9 ± 17.2 | 30.5 ± 15.6 | 0.01 |
| Hearing Function (HF) | 65.2 ± 19.4 | 64.9 ± 18.5 | 0.79 |
| Mental Health (MH) | 44.5 ± 19.1 | 39.4 ± 18.6 | 0.04 |
| Overall score (OS) | 49.7 ± 19.2 | 40.2 ± 16.8 | 0.01 |
Bold values are represent the statistical significance
Conclusion
To conclude, higher the MERI score, higher is the disease extent, lower is the rate of graft uptake, higher is the level of hearing loss and poorer the QOL. Patients with lower MERI have higher rate of graft uptake. MERI is a good prognostic factor for graft uptake and hearing benefit after surgery. Based on the MERI score, the extent to which surgical success and hearing benefit can be obtained should be explained to the patient to psychologically prepare them for a better/intermediate QOL. Attempts should be made to reduce the middle ear disease whenever possible (otorrhoea and granulation) preoperatively to improve the success rate of tympanoplasty.
Appendix: Middle ear risk index chart
| Risk factor | Value-assigned risk |
|---|---|
| Otorrhea (Bellucci) | |
| I—Dry | 0 |
| II—Occasionally wet | 1 |
| III—Persistently wet | 2 |
| IV—Wet, cleft palate | 3 |
| Perforation | |
| None | 0 |
| Present | 1 |
| Cholesteatoma | |
| None | 0 |
| Present | 2 |
| Ossicular status (Austin/Kartush) | |
| (0) M_I_S_ | 0 |
| (A) M_S_ | 1 |
| (B) M_S_ | 2 |
| (C) M_S_ | 3 |
| (D) M_S_ | 4 |
| (E) Ossicular head fixation | 2 |
| (F) Stapes fixation | 3 |
| Middle ear: granular or effusion | |
| No | 0 |
| Yes | 2 |
| Previous surgery | |
| None | 0 |
| Staged | 1 |
| Revision | 2 |
| Smoker | |
| No | 0 |
| Yes | 2 |
Compliance with Ethical Standards
Conflict of interest
The author declares that they have no conflict of interest.
Ethical Standards
Research involving human participants with institutional ethical committee clearance.
Informed Consent
Written informed consent obtained from participants before enrolling for the study.
Footnotes
Publisher's Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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