Skip to main content
SpringerLink
Log in

Development and validation of the Zurich chronic middle ear inventory (ZCMEI-21): an electronic questionnaire for assessing quality of life in patients with chronic otitis media

  • Otology
  • Published:
European Archives of Oto-Rhino-Laryngology Aims and scope Submit manuscript

Abstract

Because existing patient-reported outcome measures (PROMs) specific for chronic otitis media (COM) are lacking certain relevant symptoms and dimensions of health-related quality of life (HRQoL), we aimed to develop and validate a new questionnaire for comprehensively measuring HRQoL in adult patients with COM. An expert panel and patients were involved in developing the first version of the Zurich chronic middle ear inventory, containing 33 items (ZCMEI-33). An electronic application was chosen not only to provide maximal data quality, but also to facilitate and accelerate data analysis. Item reduction was performed by testing the questionnaire in a first cohort (n = 85). Using sequential statistical analysis, the ZCMEI-33 was reduced to 21 items (ZCMEI-21). Subsequently, the ZCMEI-21 was validated in a second cohort (n = 76). Validation revealed a Cronbach’s α of 0.91, indicating excellent internal consistency. Moreover, the ZCMEI-21 was able to discriminate between patients with COM and healthy participants (p < 0.0001), thus possessing good discrimination validity. Assessing criterion validity, the ZCMEI-21 total score was compared to a question directly addressing HRQoL and the EQ-5D descriptive system score, a generic measure of HRQoL. Whereas the ZCMEI-21 total score and the EQ-5D descriptive system score were only moderately correlated (r = 0.60, p < 0.0001), the ZCMEI-21 total score and the question directly addressing HRQoL showed a strong correlation (r = 0.74, p < 0.0001). In conclusion, sufficient information on reliability and validity was obtained to propagate the application of the ZCMEI-21 to quantify HRQoL in patients with COM.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2

Similar content being viewed by others

Abbreviations

BYOD:

Bring your own device

CES:

Chronic ear survey

COM:

Chronic otitis media

COMOT-15:

Chronic otitis media outcome test

COMQ-12:

Chronic otitis media questionnaire

EORTC QLQ-C30:

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire

ePROM:

Electronic patient-reported outcome measure

EQ-5D:

European quality of life-5 dimensions questionnaire

HRQoL:

Health-related quality of life

ITC:

Item total correlation

max:

Highest value

min:

Lowest value

OMCC:

Chronic otitis media with cholesteatoma

OMCS:

Otitis media chronica simplex

PCA:

Principal component analysis

PRO:

Patient-reported outcome

PROM:

Patient-reported outcome measure

Q:

Question (“item”)

SD:

Standard deviation

SNOT-20:

Sinonasal outcome test

ZCMEI-21:

Zurich chronic middle ear inventory, final version containing 21 questions

ZCMEI-33:

Zurich chronic middle ear inventory, first version containing 33 questions

References

  1. Epstein RS, Sherwood LM (1996) From outcomes research to disease management: a guide for the perplexed. Ann Intern Med 124:832–837

    Article  CAS  PubMed  Google Scholar 

  2. Black N (2013) Patient reported outcome measures may transform healthcare. Br Med J 346:19–21

    Article  Google Scholar 

  3. Guyatt GH, Feeny DH, Patrick DL (1993) Measuring health-related quality of life. Ann Intern Med 118:622–629

    Article  CAS  PubMed  Google Scholar 

  4. Bhattacharyya N (2004) Outcomes research in otology. ORL 66:214–220

    Article  PubMed  Google Scholar 

  5. Coons SJ, Eremenco S, Lundy JJ et al (2014) Capturing patient-reported outcome (PRO) data electronically: the past, present, and promise of ePRO measurement in clinical trials. Patient 8:301–309

    Article  PubMed Central  Google Scholar 

  6. Guyatt GH, Bombardier C, Tugwell PX (1986) Measuring disease-specific quality of life in clinical trials. Can Med Assoc J 134:889–895

    CAS  Google Scholar 

  7. Alakärppä A, Alho O-P (2012) Patient-recorded outcomes and quality of life in evidence-based medicine databases on most common ear, throat and nose procedures: a systematic review. Clin Otolaryngol 37:436–445

    Article  PubMed  Google Scholar 

  8. Piccirillo JF, Merritt MG, Richards ML (2002) Psychometric and clinimetric validity of the 20-item Sino-Nasal Outcome Test (SNOT-20). Otolaryngol Head Neck Surg 126:41–47

    Article  PubMed  Google Scholar 

  9. Bjordal K, Hammerlid E, Ahlner-Elmqvist M et al (1999) Quality of life in head and neck cancer patients: validation of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-H&N35. J Clin Oncol 17:1008–1019

    CAS  PubMed  Google Scholar 

  10. Nadol JB Jr, Staecker H, Gliklich RE (2000) Outcomes assessment for chronic otitis media: the chronic ear survey. Laryngoscope 110:32–35

    Article  PubMed  Google Scholar 

  11. Baumann I, Kurpiers B, Plinkert PK, Praetorius M (2009) Development and validation of the Chronic Otitis Media Outcome Test 15 (COMOT-15). Measurement of health-related quality of life in patients with chronic otitis media. HNO 57:889–895

    Article  CAS  PubMed  Google Scholar 

  12. Phillips JS, Haggard M, Yung M (2014) A new health-related quality of life measure for active chronic otitis media (COMQ-12): development and initial validation. Otol Neurotol 35:454–458

    Article  PubMed  Google Scholar 

  13. Hallberg LRM, Hallberg U, Kramer SE (2008) Self-reported hearing difficulties, communication strategies and psychological general well-being (quality of life) in patients with acquired hearing impairment. Disabil Rehabil 30:203–212

    Article  PubMed  Google Scholar 

  14. Bakir S, Kinis V, Bez Y et al (2012) Mental health and quality of life in patients with chronic otitis media. Eur Arch Otorhinolaryngol 270:521–526

    Article  PubMed  Google Scholar 

  15. Choi SY, Cho Y-SS, Lee NJ et al (2012) Factors associated with quality of life after ear surgery in patients with chronic otitis media. Arch Otolaryngol Head Neck Surg 138:840–845

    Article  PubMed  Google Scholar 

  16. Mulrow CD, Aguilar C, Endicott JE et al (1990) Quality-of-life changes and hearing impairment: a randomized trial. Ann Intern Med 113:188–194

    Article  CAS  PubMed  Google Scholar 

  17. Carabellese C, Appollonio I, Rozzini R et al (1993) Sensory impairment and quality of life in a community elderly population. J Am Geriatr Soc 41:401–407

    Article  CAS  PubMed  Google Scholar 

  18. Cronbach LJ (1951) Coefficient alpha and the internal structure of tests. Psychometrika 16:297–334

    Article  Google Scholar 

  19. Rabin R, de Charro F (2001) EQ-5D: a measure of health status from the EuroQol Group. Ann Med 33:337–343

    Article  CAS  PubMed  Google Scholar 

  20. Stull DE, Leidy NK, Parasuraman B, Chassany O (2009) Optimal recall periods for patient-reported outcomes: challenges and potential solutions. Curr Med Res Opin 25:929–942

    Article  PubMed  Google Scholar 

  21. Gwaltney CJ, Shields AL, Shiffman S (2008) Equivalence of electronic and paper-and-pencil administration of patient-reported outcome measures: a meta-analytic review. Value Heal 11:322–333

    Article  Google Scholar 

  22. Phillips JS, Yung MW (2015) A systematic review of patient-reported outcome measures for chronic suppurative otitis media. Laryngoscope. doi:10.1002/lary.25657

    Google Scholar 

  23. Bess FH (2000) The role of generic health-related quality of life measures in establishing audiological rehabilitation outcomes. Ear Hear 21:74S–79S

    Article  CAS  PubMed  Google Scholar 

  24. Smyth GD, Patterson CC (1985) Results of middle ear reconstruction: do patients and surgeons agree? Am J Otol 6:276–279

    CAS  PubMed  Google Scholar 

Download references

Acknowledgments

The authors would like to acknowledge René Holzreuter and Daniel Zürrer for their advice and support.

Author information

Authors and Affiliations

  1. Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Zurich, Zurich, Switzerland

    David Bächinger, Christof Röösli & Alexander M. Huber

  2. University of Zurich, Zurich, Switzerland

    David Bächinger, Christof Röösli & Alexander M. Huber

  3. Institute of Medical Psychology, University Hospital Heidelberg, Heidelberg, Germany

    Beate Ditzen

Authors
  1. David Bächinger
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Christof Röösli
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Beate Ditzen
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Alexander M. Huber
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to David Bächinger.

Ethics declarations

Conflict of interest

David Bächinger declares that he has no conflict of interest. Christof Röösli declares that he has no conflict of interest. Beate Ditzen declares that she has no conflict of interest. Alexander M. Huber declares that he has no conflict of interest.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional, cantonal and national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the study.

Electronic supplementary material

Below is the link to the electronic supplementary material.

Supplementary material 1 (PDF 72 kb)

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Bächinger, D., Röösli, C., Ditzen, B. et al. Development and validation of the Zurich chronic middle ear inventory (ZCMEI-21): an electronic questionnaire for assessing quality of life in patients with chronic otitis media. Eur Arch Otorhinolaryngol 273, 3073–3081 (2016). https://doi.org/10.1007/s00405-016-3915-7

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00405-016-3915-7

Keywords

Search

Navigation