Abstract
Objective
This study evaluated outcomes of stapes surgery in otosclerosis patients by assessing audiometric results and health‐related quality of life (HRQOL) using the Dutch Stapesplasty Outcome Test‐25 (SPOT‐25) questionnaire. Additionally, the role of SPOT‐25 in preoperative decision‐making and as a follow‐up tool was explored.
Study Design
A prospective, multicenter cohort study.
Setting
One tertiary academic medical center and 3 secondary referral centers.
Methods
Data from 115 adult patients undergoing primary stapes surgery was analyzed. Audiometric outcomes were measured using pure‐tone audiometry results and word recognition score (WRS). HRQOL was assessed using SPOT‐25, Glasgow Health Status Questionnaire, and Glasgow Benefit Inventory. Pre‐ and postoperative outcomes were compared, and correlations between pure‐tone audiometry results, WRS, and HRQOL were analyzed. Outcomes were compared between patients receiving 0.4 and 0.6 mm diameter pistons, and the impact of preoperative pure‐tone audiometry results was analyzed.
Results
Significant postoperative improvements were observed in all audiometric measures (mean air conduction gain of 22 dB and air–bone gap (ABG) improvement of 18 dB). HRQOL also improved significantly (mean SPOT‐25 score improved from 48 to 27). The 0.6 mm piston group had a significantly smaller postoperative ABG than the 0.4 mm group. Patients with a preoperative ABG ≤ 15 dB had a mean SPOT‐25 gain of 19 (SD 22), whereas those with a preoperative ABG > 15 dB had a gain of 21 (SD 18).
Conclusion
Stapes surgery significantly improves hearing and HRQOL. The SPOT‐25 is a valuable tool for evaluating HRQOL and may assist in preoperative decision‐making in patients with varying hearing impairments.
Level of Evidence
III.
Keywords: HRQOL, PROMs, SPOT‐25, stapes surgery
Otosclerosis is a pathological condition characterized by abnormal bone formation predominantly in the region of the oval window, consequently resulting in various degrees of fixation of the stapes footplate. 1 Typical symptoms include conductive or mixed hearing loss, vertigo, and tinnitus. 2 Surgical intervention might be indicated, depending on the level of conductive hearing loss, patient's wishes, and shared decision‐making.
Evaluation of hearing outcomes usually is related to the hearing gain measured on standardized postoperative pure‐tone audiometry. In 1995, the American Academy of Otolaryngology–Head and Neck Surgery (AAO‐HNS) established minimal reporting standards to guide the assessment of postoperative results. 3 Additionally, Gurgel et al published a new format in 2012 to integrate the evaluation of pure‐tone audiometry results with speech perception and the contralateral ear. 4 These comprehensive reporting standards provide a more accurate evaluation of postoperative hearing outcomes and the possibility to compare findings between different clinics.
Several studies have evaluated possible correlations between pure‐tone audiometry outcomes and patients' subjective perceptions of their hearing performance. 5 , 6 This reported disparity between these 2 parameters emphasizes the importance of incorporating and standardizing the patient's perspective when assessing the surgical success of otosclerosis surgery. Patient‐reported outcome measures (PROMs), which use standardized questionnaires to assess patient satisfaction and treatment efficacy, have become essential in both clinical decision‐making and study groups evaluating treatment efficacy. 7 Including PROMs provides a more comprehensive understanding of treatment outcomes by incorporating the patient's subjective experience, which ultimately is the primary goal of medical treatment.
Lailach et al developed the first scientifically validated tool specifically designed to assess health‐related quality of life (HRQOL) in patients with otosclerosis. 8 This tool, known as the Stapesplasty Outcome Test‐25 (SPOT‐25), is a 25‐item questionnaire originally developed in the German language, designed to evaluate the impact of hearing loss due to otosclerosis on various aspects of HRQOL. The SPOT‐25 was translated and culturally adapted to the Dutch language and subsequently validated in a Dutch population of otosclerosis patients undergoing primary stapes surgery by our study group. 9
Our study aims to evaluate the effectiveness of surgical intervention by assessing both objective audiometric measures and HRQOL. 8 Furthermore, we will investigate the potential utility of the SPOT‐25 in preoperative and postoperative assessments.
Methods
Study Design and Population
A prospective, multicenter cohort study was conducted across 4 medical centers in the Netherlands: 1 tertiary referral center and 3 secondary referral centers, all with decades of experience in otosclerosis surgery. Adult otosclerosis patients scheduled for primary stapes surgery were included between November 2018 and April 2024. The diagnosis otosclerosis was based on a clinical history of progressive hearing loss, normal otomicroscopy and pure‐tone audiometry showing a conductive or combined hearing loss in the range of 500, 1000, 2000, and 4000 Hz. Exclusion criteria were patients who underwent prior middle ear surgery, indications for surgery other than otosclerosis (ie, congenital middle ear anomalies, fixation of the incus or malleus head), or concomitant ear diseases (eg, suppurative otitis media or cholesteatoma). The protocol for this study was approved by the Institutional Review Board of the University Medical Center Utrecht (protocol 18‐768/C; V.1, November 2018).
Intervention
An endaural procedure under general anesthesia, with or without an intercartilaginous incision, was performed in each case. The endomeatal flap was raised using Rosen's incision, and it was lifted once the annulus fibrosis was found. The surgeon identified the facial nerve, chorda tympani nerve, and ossicles. The surgeon checked to see if the stapes was fixed and sclerotic. If this was the case, the stapes superstructure was removed by cleaving the incudostapedial joint, transecting the stapedius muscle and the posterior crus of the stapes, and breaching the anterior crus of the stapes. A KTP laser (Lumenis, Inc.), a Skeeter microdrill (Medtronic Xomed Inc.), micro‐instruments, or a combination of these were used to fenestrate the stapes footplate. A Teflon wire piston, a Kurz titanium piston, or a Causse loop Teflon piston was positioned between the incus and the fenestration in the stapes footplate. The oval window was sealed using blood clots and/or allogeneic tissue (Gelfoam, Pfizer).
Outcomes
Pure‐Tone Audiometry
Preoperative and postoperative pure‐tone audiometry results were collected. According to the 1995 American Academy of Otolaryngology Head and Neck Surgery Committee on Hearing and Equilibrium guidelines, air conduction (AC) and bone conduction (BC) thresholds at frequencies of 0.5, 1, 2, and 3 kHz were included. 3 To obtain the threshold at 3 kHz, we averaged the thresholds at 2 and 4 kHz. The pre‐ and postoperative AC and BC thresholds at 0.5, 1, 2, and 3 kHz and corresponding air–bone gaps (ABGs) were calculated based on the averages of the mentioned pure‐tone audiometry results.
Speech Audiometry
Speech audiometry was performed to measure the word recognition score (WRS), which represents the percentage of monosyllabic words correctly repeated at 60 or 65 dB.
PROMs
The patient‐reported outcome was evaluated using the following 3 questionnaires:
The SPOT‐25 is a translated 25‐item questionnaire that assesses the HRQOL in otosclerosis patients, covering domains such as hearing function, tinnitus, mental condition, and social restrictions. A 5‐point Likert scale was utilized to quantify the overall impact. The total score ranges from 0 (indicating the least restriction in HRQOL) to 100 points (representing the greatest restriction in HRQOL). The complete questionnaire can be found in Supplemental Material 1.
The Glasgow Health Status Questionnaire (GHSQ), which is an 18‐item questionnaire validated for measuring influence of otologic pathology on quality of life. It encompasses 3 domains: general, social support, and physical health based on a 5‐point Likert scale. The total score ranges from 0 (indicating low health status) to 100 points (indicating high health status). The complete questionnaire can be found in Supplemental Material 2.
The Glasgow Benefit Inventory (GBI), which is an 18‐item questionnaire assessing alterations in health status after surgical interventions. A specific version of the GBI for otorhinolaryngological procedures was applied. It consists of similar domains as in the previously mentioned GHSQ, employing the same 5‐point Likert scale. The total score ranges from −100 (indicating maximal negative impact) through 0 (indicating no impact) to +100 points (indicating maximal positive impact). The complete questionnaire can be found in Supplemental Material 3.
The questionnaires were completed before the procedure (SPOT‐25 and GHSQ) and 6 to 8 weeks postoperatively (SPOT‐25, GHSQ and GBI).
The potential integration of the SPOT‐25 questionnaire for consultations and determining indications for stapes surgery was evaluated by analyzing the effect of preoperative ABG, AC, and SPOT‐25 score on the improvement in the SPOT‐25 total score following surgery. Preoperative ABG, AC, and SPOT‐25 total score were dichotomized using various thresholds. For ABG, comparisons were made between patients with preoperative ABG as follows: ≤15 dB and >15 dB, ≤25 dB and >25 dB, and ≤35 dB and >35 dB. For AC, comparisons were made between preoperative AC as follows: ≤40 dB and >40 dB, ≤60 dB and >60 dB, and ≤80 dB and >80 dB. For SPOT‐25 total score, comparisons were made between preoperative AC as follows: ≤80 dB and >80 dB, ≤60 dB and >60 dB, ≤40 dB and >40 dB, and ≤20 dB and >20 dB. These thresholds were used to assess whether different degrees of preoperative hearing impairment, objectively or subjectively, impacted the improvement in SPOT‐25 scores.
Additionally, audiometric and HRQOL outcomes were compared between patients who underwent stapes surgery using a 0.4 mm piston diameter and those who received a 0.6 mm piston diameter.
Statistical Analysis
Missing data were handled using multiple imputation. The percentage of missing data never exceeded 15% within the independent questionnaire items. Ten imputed datasets were generated, and analyses were conducted using pooled estimates derived from these datasets. In cases where pooled estimates were unavailable, the results were obtained by averaging the values across all 10 imputed datasets. Means and standard deviations (SD) were calculated for continuous variables. Frequencies and percentages were calculated for categorical variables. A test for normality, the Shapiro–Wilk test, was used to assess whether variables were normally distributed. Variables were normally distributed and therefore parametric tests were used. Between‐group differences in continuous variables were tested using the independent samples t‐test. The paired samples t‐test was used to evaluate difference between pre‐ and postoperative pure‐tone audiometry results, WRS, and questionnaire scores. Pearson's correlation coefficients were used to evaluate the correlation between the continuous variables. Pearson's correlation coefficient was calculated; strong, good, moderate, and weak correlations were defined as correlation coefficients of more than 0.70, between 0.50 and 0.70, between 0.30 and 0.50, and less than 0.30, respectively. Mean differences and 95% confidence intervals were calculated when 2 groups were compared. The statistical analyses were performed using IBM SPSS Statistics version 26.0 (IBM Corp.).
Results
A total of 115 otosclerosis patients completed the pre‐ and postoperative questionnaire. Fifteen patients did not complete the postoperative questionnaire that was sent to them and these 15 patients were excluded from the study for that reason. The mean age of the participants was 48 years (SD 11), with 64% being female. The mean time interval between surgery and the completion of postoperative questionnaires was 8 weeks. Postoperative statistically significant improvements were observed across all audiometric measurements. The mean gain in AC was 22 dB (SD 14), mean ABG improvement was 18 dB (SD 11), and closure of ABG within 10 dB was 64.3%. See Table 1 for audiometric outcomes.
Table 1.
Pure‐Tone Audiometry Results
| Preoperative | Postoperative | Gain | |
|---|---|---|---|
| Air conduction | |||
| Mean (SD), dB | 56 (15) | 35 (17) | 22 (14)* |
| Bone conduction | |||
| Mean (SD), dB | 28 (12) | 25 (15) | 3 (8)* |
| Air–bone gap | |||
| Mean (SD), dB | 28 (9) | 10 (7) | 18 (11)* |
| ABG closure ≤ 10 dB | |||
| n (%) | n/a | 74 (64) | n/a |
| ABG closure ≤ 20 dB | |||
| n (%) | n/a | 107 (93) | n/a |
| WRS 60 dB | |||
| Mean (SD), % | 11 (21) | 63 (33) | 52 (34)* |
| WRS 65 dB | |||
| Mean (SD), % | 19 (28) | 72 (29) | 53 (32)* |
Data from 115 patients were included.
Abbreviations: ABG, air–bone gap; n, number of patients; SD, standard deviation; WRS, word recognition score.
Difference is statistically significant (P < .05).
The scores from the HRQOL questionnaires are presented in Tables 2 and 3. The total score and all subscores of the SPOT‐25 showed significant improvement, meaning HRQOL improved across all domains. The preoperative total score was 48 (SD 15), while the mean postoperative score was 27 (SD 19). The GHSQ shows an improvement in health status, particularly in the general subscore, with a preoperative score of 49 (SD 15) and a postoperative score of 66 (SD 19). The changes in both GHSQ and SPOT‐25 scores after surgery were statistically significant (P < .05). The GBI also demonstrates an overall positive improvement in HRQOL after stapes surgery, with the greatest improvement in the general subscore (32 [SD 25]). A total of 103 patients reported a postoperative GBI score greater than 0, while 59 patients had a score exceeding 20.
Table 2.
SPOT‐25 Scores
| Total | Hearing function | Tinnitus | Mental condition | Social restriction | |
|---|---|---|---|---|---|
| SPOT‐25 preoperative | |||||
| Mean (SD) | 48 (15) | 59 (14) | 41 (30) | 41 (18) | 37 (22) |
| SPOT‐25 postoperative | |||||
| Mean (SD) | 27 (19) | 32 (23) | 29 (25) | 23 (20) | 19 (19) |
| SPOT‐25 gain | 21 (19)* | 27 (24)* | 12 (27)* | 18 (20)* | 17 (21)* |
| Mean (SD) |
Data from 115 patients were included.
Abbreviations: SD, standard deviation; SPOT‐25, Stapesplasty Outcome Test‐25.
Difference is statistically significant (P < .05).
Table 3.
GHSQ and GBI Scores
| Total | General | Social support | Mental health | |
|---|---|---|---|---|
| GHSQ preoperative | ||||
| Mean (SD) | 56 (12) | 49 (15) | 80 (15) | 58 (20) |
| GHSQ postoperative | ||||
| Mean (SD) | 67 (15) | 66 (19) | 81 (17) | 58 (20) |
| GHSQ gain | ||||
| Mean (SD) | 11* (11) | 17* (16) | 1 (15) | 0 (15) |
| GBI postoperative | ||||
| Mean (SD) | 22 (18) | 32 (25) | 3 (14) | −1 (15) |
Data from 115 patients were included.
Abbreviations: GBI, Glasgow Benefit Inventory; GHSQ, Glasgow Health Status Questionnaire; SD, standard deviation.
Difference is statistically significant (P < .05).
When evaluating the correlations between the HRQOL questionnaires and pure‐tone audiometry results, no strong correlations were found (Table 4). However, we did find moderate correlations between postoperative AC and WRS and HRQOL.
Table 4.
Correlations for Audiometric Results and Questionnaires
| Spot‐25 postoperative | SPOT‐25 gain | GHSQ postoperative | GHSQ gain | GBI postoperative | |
|---|---|---|---|---|---|
| Postoperative AC | 0.502* | −0.418* | −0.480* | −0.364* | −0.292* |
| Postoperative ABG | 0.225* | −0.263* | −0.218* | −0.181 | −0.238* |
| Postoperative WRS (60 dB) | −0.510* | 0.419* | 0.479* | 0.341* | 0.238* |
| Postoperative WRS (65 dB) | −0.457* | 0.396* | 0.430* | 0.328* | 0.279* |
Abbreviations: ABG, air–bone gap; AC, air conduction; BC, bone conduction; WRS, word recognition score.
Correlation is statistically significant (P < .05).
Of the 115 patients, 90 received either a 0.4‐ or 0.6‐mm piston. The remaining patients either received a piston of a different diameter, or the size was not specified in the surgical report. Table 5 provides an overview of the pure‐tone audiometry results and HRQOL for these 2 groups. The mean gain in total SPOT‐25 score was 20 (SD 19) in the 0.4 mm group and 23 (SD 19) in the 0.6 mm group, with no statistically significant difference observed. Only the postoperative ABG showed a statistically significantly difference (P < .001), with a mean difference of 4 dB in favor of the 0.6 mm group.
Table 5.
Comparison of 0.4 mm and 0.6 mm Pistons
| 0.4 mm piston (n = 50) | 0.6 mm piston (n = 40) | Mean difference (95% CI) | |
|---|---|---|---|
| Gain total score SPOT‐25 | |||
| Mean (SD) | 20 (19) | 23 (19) | −2.86 [−10.58, 4.87] |
| Gain total score GHSQ | |||
| Mean (SD) | 11 (10) | 12 (15) | −0.52 [−5.65, 4.62] |
| Postoperative AC, dB | |||
| Mean (SD) | 33 (16) | 34 (17) | −0.25 [−7.01, 6.51] |
| Gain AC, dB | |||
| Mean (SD) | 22 (11) | 24 (14) | −1.85 [−6.99, 3.29] |
| Postoperative ABG, dB | |||
| Mean (SD) | 11 (6) | 7 (4) | −3.98* [1.78, 6.19] |
| Gain ABG, dB | |||
| Mean (SD) | 17 (9) | 21 (10) | −3.55 [−7.44, 0.35] |
| ABG closure ≤ 10 dB | |||
| n (%) | 27 (54) | 31 (78) | n/a |
| Gain WRS 60 dB, % | |||
| Mean (SD) | 52 (33) | 56 (34) | −4.04 [−17.85, 9.77] |
| Gain WRS 65 dB, % | |||
| Mean (SD) | 53 (34) | 58 (35) | −4.90 [−19.27, 9.47] |
Abbreviations: 95% CI, 95% confidence interval; ABG, air–bone gap; AC, air conduction; BC, bone conduction; IQR, interquartile range; n, number of patients; SD, standard deviation; WRS, word recognition score.
Difference is statistically significant (P < .05).
Table 6 summarizes the relation between preoperative ABG and postoperative gain in SPOT‐25 score. Patients with a preoperative ABG of 15 dB or less experienced a mean SPOT‐25 gain of 19 (SD 22), while those with a preoperative ABG greater than 15 dB had a mean gain of 21 (SD 18). Notably, patients with a preoperative ABG of 25 dB or less demonstrated a significantly higher mean SPOT‐25 gain of 25 (SD 18), compared to those with a preoperative ABG greater than 25 dB, who had a mean gain of 18 (SD 18) (P = .033). For further details, see Table 6.
Table 6.
The Effect of Preoperative ABG on Gain in SPOT‐25 Score
| Preoperative ABG | Preoperative ABG | Preoperative ABG | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Mean (SD) | Mean (SD) | Mean (SD) | |||||||
| ≤15 dB (n = 10) | >15 dB (n = 105) | Mean difference (95% CI) | ≤25 dB (n = 49) | >25 dB (n = 66) | Mean difference (95% CI) | ≤35 dB (n = 91) | >35 dB (n = 24) | Mean difference (95% CI) | |
| Gain Total SPOT‐25 | 19 (22) | 21 (18) | 2.38 [−9.83, 14.58] | 25 (18) | 18 (18) | −7.45* [−14.29, −0.61] | 21 (19) | 20 (19) | −0.81 [−9.28, 7.66] |
Abbreviations: ABG, air–bone gap; n, number of patients; SD, standard deviation; 95% CI, 95% confidence interval.
Difference is statistically significant (P < .05).
Table 7 illustrates the association between preoperative AC thresholds and postoperative SPOT‐25 score improvements. Patients with a preoperative AC of 80 dB or less showed a significantly greater mean SPOT‐25 gain of 22 (SD 19) compared to those with a preoperative AC above 80 dB, who had a mean gain of 7 (SD 13) (P = .009). In patients with a preoperative AC over 80 dB, the mean preoperative BC was 56 dB (SD 9), and the ABG was 36 dB (SD 9). These patients had a mean gain in AC of 28 dB (SD 10), a BC gain of 1 dB (SD 8), and an ABG gain of 27 dB (SD 14), resulting in a postoperative BC of 55 dB (SD 7). Additional information can be found in Table 7.
Table 7.
The Effect of Preoperative AC on Gain in SPOT‐25 Score
| Preoperative AC | Preoperative AC | Preoperative AC | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Mean (SD) | Mean (SD) | Mean (SD) | |||||||
| ≤40 dB (n = 11) | >40 dB (n = 104) | Mean difference (95% CI) | ≤60 dB (n = 78) | >60 dB (n = 37) | Mean difference (95% CI) | ≤80 dB (n = 105) | >80 dB (n = 10) | Mean difference (95% CI) | |
| Gain Total SPOT‐25 | 22 (14) | 21 (19) | −0.79 [−12.50, 10.92] | 23 (18) | 17 (20) | −5.35 [−12.67, 1.97] | 22 (19) | 7 (13) | −15.90* [−27.75, −4.04] |
Abbreviations: AC, air conduction; n, number of patients; SD, standard deviation; 95% CI, 95% confidence interval.
Difference is statistically significant (P < .05).
Table 8 presents the preoperative SPOT‐25 in relation to postoperative gains in SPOT‐25 score. Patients with a preoperative SPOT‐25 score greater than 60 had a significantly larger mean gain of 32 (SD 20), compared to those with a score 60 or less (18 (SD 17) (P = .001). Similarly, patients with a preoperative SPOT‐25 score above 40 had a mean gain of 24 (SD 20), while those with a score of 40 or less had a mean gain of 12 (SD 10) (P = .001). See Table 8 for further details.
Table 8.
The Effect of Preoperative SPOT‐25 on Gain in SPOT‐25 Score
| Preoperative SPOT‐25 | Preoperative SPOT‐25 | Preoperative SPOT‐25 | Preoperative SPOT‐25 | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mean (SD) | Mean (SD) | Mean (SD) | Mean (SD) | |||||||||
| ≤80 (n = 114) | >80 (n = 1) | Mean difference (95% CI) | ≤60 (n = 92) | >60 (n = 23) | Mean difference (95% CI) | ≤40 (n = 31) | >40 (n = 84) | Mean difference (95% CI) | ≤20 (n = 3) | >20 (n = 112) | Mean difference (95% CI) | |
| Gain total SPOT‐25 | 21 (19) | 27 (0) | 6.04 [−30.8, 42.82] | 18 (17) | 32 (20) | 13.62* [5.41, 21.82] | 12 (10) | 24 (20) | 12.18* [4.75, 19.61] | 13 (5) | 21 (19) | 8.71 [−12.80, 30.22] |
Abbreviations: AC, air conduction; n, number of patients; SD, standard deviation; 95% CI, 95% confidence interval.
Difference is statistically significant (P < .05).
Discussion
In this study, we evaluated the objective and subjective outcomes of stapes surgery in 115 adult patients, and assessed the correlation between PROMs and pure‐tone audiometry results. We also explored the potential role of the SPOT‐25 questionnaire in preoperative decision‐making and as a tool for monitoring surgical outcomes. Lastly, we focused on the effectiveness of 0.4 mm versus 0.6 mm pistons to provide further insights into the impact of piston size on postoperative outcomes, as discussed in our previously published article. 10 Our findings demonstrated statistically significant improvement in objective hearing measures and HRQOL following stapes surgery. Notably, the 0.6 mm piston resulted in lower postoperative mean ABG compared to the 0.4 mm piston. Other pure‐tone audiometry results and HRQOL were not statistically significant. Weak to moderate, yet statistically significant, correlations were observed between various pure‐tone audiometry results and PROMs.
Previous studies have investigated the impact of stapes surgery on pure‐tone audiometry results and HRQOL. A study using the Danish SPOT‐25 questionnaire reported significant improvements in pure‐tone audiometry results and all SPOT‐25 subscores, except for the tinnitus subscore, which showed only modest improvement. 11 This is in line with the results of the article of Weiss et al. 12 Lailach et al found significant improvements across all pure‐tone audiometry measurements and SPOT‐25 domains. 12 , 13 Our findings are consistent with these results, showing significant improvements in both pure‐tone audiometry results and all SPOT‐25 domains, underscoring the role of stapes surgery in improving both HRQOL and objective hearing outcomes. Indeed, hearing improvement, to a certain extent, enhances the quality of life for our patients across various domains.
In addition, the Danish study found a moderate correlation (r = 0.37) between total postoperative SPOT‐25 scores and postoperative AC. Similarly, a validation study on the French version of the SPOT‐25 reported no statistically significant correlation between pure‐tone audiometry and SPOT‐25 scores. 13 The original SPOT‐25 developers found a similar correlation of 0.37 14 In our study, we observed a higher, though still not strong, correlation (r = 0.502), emphasizing the need to integrate PROMs, particularly the SPOT‐25, into the evaluation of HRQOL after stapes surgery.
The SPOT‐25 questionnaire was originally designed as a postoperative follow‐up tool, and the weak to moderate correlations with pure‐tone audiometry results highlight its value in assessing the subjective outcomes of surgery. These findings underscore the importance of incorporating patient‐perceived HRQOL into clinical assessments alongside objective audiometric data.
Moreover, the SPOT‐25 questionnaire has the potential to refine surgical indications. For instance, in patients with preoperative AC levels above 80 dB, we observed significantly less improvement in HRQOL after surgery. This group also had higher preoperative BC thresholds, which did not improve significantly after stapes surgery. Despite notable improvement in ABG, residual hearing impairment continued to significantly affect HRQOL. These factors should be carefully considered in preoperative decision‐making.
The SPOT‐25 questionnaire may also assist in determining optimal surgical indication for patients with small ABGs. In otosclerosis cases with large ABGs, stapedotomy is typically the preferred treatment. However, for patients with smaller ABGs (ie, less than 20 dB nHL), both patients and surgeons may refrain from surgery and postpone a possible procedure. There is considerable variation in the literature regarding the preoperative ABG thresholds considered appropriate for stapes surgery, with recommendations ranging from 15 to 30 dB. 15 Nevertheless, our findings suggest that patients with a small preoperative ABG (<15 dB) experienced similar improvements in HRQOL as those with larger ABGs. Therefore, a small ABG should not be considered an absolute contraindication for surgery. In such cases, the SPOT‐25 questionnaire can help predict the expected HRQOL improvement, assisting in the decision‐making process.
A key strength of our study is that it is the first to evaluate HRQOL before and after stapes surgery using the Dutch version of the SPOT‐25 questionnaire. The amount of missing data was minimal, with no more than 15% missing per questionnaire item, and we used imputation techniques to preserve the integrity of the dataset, rather than excluding patients with incomplete responses. Furthermore, the prospective study design and high response rate minimized the risk of selection bias. However, a limitation is the relatively short follow‐up period (6‐8 weeks), which may not have captured the full extent of postoperative improvements in pure‐tone audiometry results and HRQOL that could occur over a longer period.
Future research should investigate the impact of revision stapes surgery on HRQOL, which is another group of patients with otosclerosis. This might provide valuable insights for optimizing patient consultation and decision‐making regarding revision surgery procedures.
Conclusion
This study demonstrates significant improvements in hearing outcomes and HRQOL following stapes surgery, with the 0.6 mm piston yielding superior postoperative mean ABG compared to the 0.4 mm piston. Given the weak‐to‐moderate correlations between pure‐tone audiometry results and PROMs, the SPOT‐25 questionnaire proves to be particularly valuable in assessing HRQOL postoperatively. Moreover, our findings suggest that this tool may assist in preoperative decision‐making, particularly for patients with mild or severe hearing impairment.
Author Contributions
Maaike Jellema, design, conduct, analysis, presentation research; Esther. E. Blijleven, design, conduct, analysis, presentation research; Joeri Buwalda, conduct, presentation research; Raphael J.B. Hemler, conduct, presentation research; Huib F. van Waegeningh, conduct, presentation research; Robert J. Stokroos, presentation research; Inge Wegner, design, analysis, presentation research; Henricus G.X.M. Thomeer, design, conduct, analysis, presentation research.
Disclosures
Competing interests
None.
Funding source
None.
Supporting information
Supporting Information.
References
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