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How can we increase the quality and value of clinical research?

Clinical research is research that answers or attempts to answer a clinical question. Is this surgery effective for laryngeal cancer? What is the best way to treat snoring? Clinical research is valuable because it can aid in improving patient care.

Clinical research differs from basic science research in many fundamental ways. The most obvious difference is that real-life, clinical practice and research, unlike basic science research, involve multitudes of variables, including diagnostic methods, stage of disease, age, sex, different surgeons, different procedures, and differences in perioperative care. A "bench" research project can be designed to measure only one variable, such as the dose of chemotherapy needed to kill 50% of cancer cells in vitro. Even a "simple," carefully controlled clinical trial--for example, one comparing an antihistamine with placebo for the treatment of allergic rhinitis--involves fewer variables and is more likely to provide clear-cut results. The results, however, may not be applicable to the "usual" patient population seen in practice and treated in a standard fashion; the study population may have more severe disease than the patients you see or may be younger or older, etc. One way to make clinical research findings more relevant to the practicing clinician is to measure the outcomes as practiced in routine daily patient care.

The science of "outcomes research" was developed to evaluate the impact of healthcare on the health of patients and populations. This impact may include the cost-effectiveness of an intervention or its ability to affect the patient's quality of life. "Quality of life" (QOL) is a measure of the patient's perception of functioning, pain, or other outcomes measures relative to either general health or disease-specific measures. Standardized, statistically validated surveys completed by patients (or parents) can be used to assess these outcomes.

Many clinicians/scientists mistakenly think that surveys do not provide "objective" data and prefer to use "objective" results, such as air-bone gaps, survival curves, recurrence rates, etc. Outcomes surveys, although based on the patient's subjective experience, are in fact statistically validated objective measurements. As an analogy, a standard hearing test does not directly measure the "true" hearing level but indirectly measures the patient's subjective perception of what he/she hears as the tones are generated by the audiometer.

Another important difference for outcomes research is that it gives added "value"; i.e., it can assess not only whether the therapy works, but also whether this matters to the patient or whether the treatment is worth the cost. Clinical research using validated outcomes measures can be a powerful tool to assess patient care in an objective, scientific way.

Otolaryngology research has begun to adapt the use of validated instruments (surveys) to answer clinical questions. Outcomes research instruments may measure general health (Short Form-36 [SF-36]) or specific diseases (e.g., cancer), or they may be specialty-specific (e.g., head and neck cancer) or treatment-specific. (1)

Many editorials and subspecialty guidelines have now been written regarding the relevance and importance of the use of these tools for clinical research, including Meniere's disease, (2) surgical treatment of head and neck cancer, (3,4) rhinology, (5,6) pediatric otolaryngology, (7) otology, (8) aesthetic surgery, (9,10) and laryngology. (11)

Outcomes tools available by subspecialty for head and neck diseases include general health measures, such as the SF-36, (12) and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ). (13) Disease-specific measures for head and neck cancer include the EORTC-HN35(14) and the University of Michigan Head and Neck Quality of Life Survey (HNQOL). (15)

Otology has long used audiometric results, such as improvement in air-bone gaps, or speech reception thresholds. These assess the patient's perception of what is heard but fail to evaluate the impact of that change on the patient's life. How much of an improvement in speech recognition threshold is "worth it"? Validated survey instruments can help assess the value of an intervention, such as cochlear implantation, to the patient's functioning in daily life. Otologic instruments for hearing loss include the Hearing Handicap Inventory for the Elderly (HHIE)16 and the Hearing Handicap Inventory for Adults (HHIA). (17) Tinnitus can be assessed with the Tinnitus Handicap Inventory (THI) (18) and dizziness with the Dizziness Handicap Inventory (DHI). (19) The Chronic Ear Survey (CES) assesses chronic ear disease. (20) Health-related QOL for cochlear implants can be assessed with the following Health-Related Quality of Life (HRQOL) instruments:Assessment of Quality of Life (AQOL), and Hearing Participation Scale (HPS). (21)

For a long time investigators had a difficult time finding relevant objective testing measures for rhinologic disorders. Sinus x-rays, CT scans, and rhinomanometry have not been shown to correlate with patient symptoms. Fortunately, several QOL measures have been developed for rhinitis. Some of the more commonly used instruments include the Sino-Nasal Outcome Test (SNOT-20), (22) the Rhinosinusitis Disability Index (RSDI), (23) the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), (24) and the Nasal Health Survey (NHS), formerly designated the Chronic Sinusitis Survey (CSS). (25) Aesthetic rhinoplasty can be assessed with the Glasgow Benefit Inventory (GBI) and Nasal Symptom Questionnaire (NSQ). (26)

The Voice Handicap Index-10 (VHI-10) and VHI-30 (27) and the Voice Symptom Scale (VoiSS) (28) can be used for voice assessments.

Pediatric disorders form a special challenge. Since the patient may not be able to complete the questionnaire, the assessments often use the parent/caregiver as a proxy for the child. Otitis Media may be assessed with the Otitis Media-6 (OM-6) (29) or the expanded OM-22, (30) as well as the Otitis Media Clinical Severity Index (OM-CSI), the Otitis Media Functional Status Questionnaire (OM-FSQ), and the Otitis Media Diary (OMD). (31,32) Sleep-disordered breathing in children has been studied with the Obstructive Sleep Apnea 18 (OSA- 18) (33) and the Obstructive Sleep Disorders 6 (OSD-6). (34) Pediatric tracheotomy functioning can be measured with the Pediatric Tracheotomy Health Status Instrument (PTHSI). (35) Versions of the rhinologic surveys, such as the Sino-Nasal 5 (SN-5), (36) and voice surveys, such as the Pediatric Voice Outcome Survey (PVOS), (37,38) are available. General health assessments of children may employ the 28-item Child Health Questionnaire (CHQ). (39)

By utilizing the validated outcomes measures that are available, it is possible to improve the quality and value of clinical research (and clinical care). Atypical format for an abstract protocol report may include the following:

* Introduction/Rationale

* Hypothesis

* Study Group

* Materials and Methods

* Outcomes Measures

* Results

* Clinical Utility

We can make a difference in our patients' lives by performing clinical research that incorporates these standardized instruments to evaluate the impact of the care provided.


(1.) Fung K, Terrell JE. Outcomes research in head and neck cancer. ORL J Otorhinolaryngol Relat Spec 2004;66:207-13.

(2.) Pearson BW, Brackmann DE. Committee on Hearing and Equilibrinm guidelines for reporting treatment results in Meniere's disease. Otolaryngol Head Neck Surg 1985;93:579-81.

(3.) Jones E, Lund VJ, Howard DJ, et al. Quality of life of patients treated surgically for head and neck cancer. J Laryngol Otol 1992;106: 238-42.

(4.) Gliklich RE, Goldsmith TA, Funk GF. Are head and neck specific quality of life measures necessary? Head Neck 1997;19:474-80.

(5.) Lund VJ. Health related quality of life in sinonasal disease. Rhinology 2001;39:182-6.

(6.) Durr DG, Desrosiers MY, Dassa C. Impact of rhinosinusitis in health care delivery: The Quebec experience. J Otolaryngol 2001;30:93-7.

(7.) Johnson RF, Stewart MG. Outcomes research in pediatric otolaryngology. ORL J Otorhinolaryngol Relat Spec 2004;66:221-6.

(8.) Bhattacharyya N. Outcomes research in otology. ORL J Otorhinolaryngol Relat Spec 2004;66:214-20.

(9.) Sharp HR, Rowe-Jones JM. Assessing outcome in aesthetic rhinoplasty. Clin Otolaryngol 2003;28:430-5.

(10.) Alsarraf R. Outcomes instruments in facial plastic surgery. Facial Plast Surg 2002;18:77-86.

(11.) Schulze SL, Rhee JS, Smith TL. Outcomes research in laryngology. Curt Opin Otolaryngol Head Neck Surg 2001;9:405-10.

(12.) Ware JE, Jr., Snow KK, Kosinski M, Gandek B. SF-36 Health Survey: Manual and Interpretation Guide. Boston: The Health Institute, New England Medical Center, 1993.

(13.) Bjordal K, Ahlner-Elmqvist M, Tollesson E, et al. Development of a European Organization for Research and Treatment of Cancer (EORTC) questionnaire module to be used in quality of life assessments in head and neck cancer patients. EORTC Quality of Life Study Group. Aeta Oncol 1994;33:879-85.

(14.) Bjordal K, de Graeff A, Fayers PM, et al. A 12 country field study of the EORTC QLQ-C30 (version 3.0) and the head and neck cancer specific module (EORTC QLQ-H&N35) in head and neck patients. EORTC Quality of Life Group. Eur J Cancer 2000;36: 1796-1807.

(15.) Terrell JE, Nanavati KA, Esclamado RM, et al. Head and neck cancer-specific quality of life: Instrument validation. Arch Otolaryngol Head Neck Surg 1997; 123:1125-32.

(16.) Ventry IM, Weinstein BE. The hearing handicap inventory for the elderly: A new tool. Ear Hear 1982;3:128-34.

(17.) Newman CW, Jacobson GP, Hug GA, Sandridge SA. Perceived hearing handicap of patients with unilateral or mild hearing loss. Ann Otol Rhinol Laryngol 1997;106:210-14.

(18.) Newman CW, Jacobson GP, Spitzer JB. Development of the Tinnitus Handicap Inventory. Arch Otolaryngol Head Neck Surg 1996; 122: 143-8.

(19.) Jacobson GP, Newman CW. The development of the Dizziness Handicap Inventory. Arch Otolaryngol Head Neck Surg 1990; 116: 424-7.

(20.) Wang PC, Nadol JB, Jr., Merchant S, et al. Validation of outcomes survey for adults with chronic suppurative otitis media. Ann Otol Rhinol Laryngol 2000; 109:249-54.

(21.) Hawthorne G, Hogan A, Giles E, et al. Evaluating the health-related quality of life effects of cochlear implants: A prospective study of an adult cochlear implant program. Int J Audiol 2004;43:183-92.

(22.) Piccirillo JF, Merritt MG, Jr., Richards ML. Psychometric and clinimetric validity of the 20-Item Sino-Nasal Outcome Test (SNOT-20). Otolaryngol Head Neck Surg 2002; 126:41-7.

(23.) Benninger MS, Senior BA. The development of the Rhinosinusitis Disability Index. Arch Otolaryngol Head Neck Surg 1997;123: 1175-9.

(24.) Juniper EF. Measuring health-related quality of life in rhinitis. J Allergy Clin Immunol 1997;99:S742-9.

(25.) Metson RB, Gliklich RE. Clinical outcomes in patients with chronic sinusitis. Laryngoscope 2000; 110:24-8.

(26.) Konstantinidis I, Triaridis S, Printza A, et al. Assessment of patient benefit from septo-rhinoplasty with the use of Glasgow Benefit Inventory (GBI) and Nasal Symptom Questionnaire (NSQ). Acta Otorhinolaryngol Belg 2003;57:123-9.

(27.) Rosen CA, Lee AS, Osborne J, et al. Development and validation of the voice handicap index-10. Laryngoscope 2004; 114:1549-56.

(28.) Wilson JA, Webb A, Carding PN, et al. The Voice Symptom Scale (VoiSS) and the Vocal Handicap Index (VHI): A comparison of structure and content. Clin Otolaryngol 2004;29:169-74.

(29.) Rosenfeld RM, Goldsmith AJ, Tetlus L, Balzano A. Quality of life for children with otitis media. Arch Otolaryngol Head Neck Surg 1997;123:1049-54.

(30.) Richards M, Giannoni C. Quality-of-life outcomes after surgical intervention for otitis media. Arch Otolaryngol Head Neck Surg 2002;128:776-82.

(31.) Alsarraf R, Jung CJ, Perkins J, et al. Otitis media health status evaluation: Apilot study for the investigation of cost-effective outcomes of recurrent acute otitis media treatment. Ann Otol Rhinol Laryngol 1998;107:120-8.

(32.) Alsarraf R, Jung CJ, Perkins J, et al. Measuring the indirect and direct costs of acute otitis media. Arch Otolaryngol Head Neck Surg 1999;125:12-18.

(33.) Franco RA, Jr., Rosenfeld RM, Rao M. First place--resident clinical science award 1999. Quality of life for children with obstructive sleep apnea. Otolaryngol Head Neck Surg 2000;123:9-16.

(34.) de Serres LM, Derkay C, Astley S, et al. Measuring quality of life in children with obstructive sleep disorders. Arch Otolaryngol Head Neck Surg 2000; 126:1423-9.

(35.) Hartnick C J, Giambra BK, Bissell C, et al. Final validation of the Pediatric Tracheotomy Health Status Instrument (PTHSI). Otolaryngol Head Neck Surg 2002; 126:228-33.

(36.) Kay DJ, Rosenfeld RM. Quality of life for children with persistent sinonasal symptoms. Otolaryngol Head Neck Surg 2003; 128:17-26.

(37.) Hartnick CJ. Validation of a pediatric voice quality-of-life instrument: The pediatric voice outcome survey. Arch Otolaryngol Head Neck Surg 2002; 128:919-22.

(38.) Hartnick CJ, Volk M, Cunningham M. Establishing normative voice-related quality of life scores within the pediatric otolaryngology population. Arch Otolaryngol Head Neck Surg 2003;129:1090-3.

(39.) Stewart MG, Friedman EM, Sulek M, et al. Quality of life and health status in pediatric tonsil and adenoid disease. Arch Otolaryngol Head Neck Surg 2000; 126:45-8.



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Title Annotation:Guest Editorial
Author:Reidy, Patrick M.
Publication:Ear, Nose and Throat Journal
Geographic Code:1USA
Date:Dec 1, 2004
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