Development and validation of a laryngopharyngeal reflux questionnaire, the Pharyngeal Reflux Symptom Questionnaire.

OBJECTIVE: To develop and validate the Pharyngeal Reflux Symptom Questionnaire (PRSQ), a comprehensive, disease-specific, self-administered questionnaire for laryngopharyngeal reflux (LPR) disease. MATERIAL AND METHODS: The PRSQ was developed based on empirical evidence from a literature review and expert input from physicians and patients and tested in a pilot study. In this validation study, a total of 228 patients were included and classified according to the Reflux Symptom Index (RSI) cut-off score. Patients with an RSI score > 13 were defined as abnormal, i.e. having LPR disease (n = 102), and those with a score between 0 and 13 were defined as normal controls (n = 126). Psychometric properties of the PRSQ were evaluated by exploring the factor structure and by evaluating internal consistency and item convergent and discriminant validity. Convergent and discriminant validity were determined by using the Laryngopharyngeal Reflux-Health Related Quality of Life questionnaire (LPR-HRQL), the RSI and the Short Form-36. RESULTS: The PRSQ was well accepted by the patients. Compliance was satisfactory and missing item rates were low. After item reduction, due to items not being conceptually relevant or scaling errors and/or low factor loadings, a construct was achieved with no scaling errors and high internal consistency (Cronbach's alpha 0.79-0.93). The correlations between the PRSQ and similar dimensions in the RSI and LPR-HRQL were generally strong. Discriminant validity was satisfactory as the questionnaire discriminated between patients with and without LPR disease. CONCLUSION: The PRSQ showed good psychometric properties and may become a valuable instrument for assessing LPR disease.

Effects of total laryngectomy on olfactory function, health-related quality of life, and communication: a 3-year follow-up study.

BACKGROUND: As total laryngectomy results in loss of airflow through the nose, one of the adverse effects for a majority of patients is the reduced or complete loss of olfactory function. However, with the introduction of a new method, the Nasal Airflow-Inducing Maneuver (NAIM), an important technique is available for laryngectomized patients to regain the ability to smell. The purpose of the present study was to assess changes in olfaction, health-related quality of life (HRQL) and communication 3 years after NAIM rehabilitation. METHODS: 18 patients (15 men and 3 women; mean age, 71 years) who had undergone laryngectomy and NAIM rehabilitation were followed longitudinally for 3 years. For comparison an age and gender matched control group with laryngeal cancer treated with radical radiotherapy was included. Olfactory function was assessed using the Questionnaire on Odor, Taste and Appetite and the Scandinavian Odor Identification Test. HRQL was assessed by: 1) the European Organization for Research and Treatment for cancer quality of life questionnaires; and 2) the Hospital Anxiety and Depression Scale. Communication was assessed by the Swedish Self-Evaluation of Communication Experiences after Laryngeal Cancer. Descriptive statistics with 95% confidence interval were calculated according to standard procedure. Changes over time as well as tests between pairs of study patients and control patients were analyzed with the Fisher nonparametric permutation test for matched pairs. RESULTS: Thirty-six months after rehabilitation 14 of 18 laryngectomized patients (78%) were smellers. There were, with one exception (sleep disturbances), no clinically or statistically significant differences between the study and the control group considering HRQL and mental distress. However, statistical differences (p < 0.001) were found between the study and the control group concerning changes in communication. CONCLUSION: Olfactory training with NAIM should be integrated into the multidisciplinary rehabilitation program after total laryngectomy. Our study shows that patients who were successfully rehabilitated concerning olfaction and communication had an overall good HRQL and no mental distress. Moreover, the EORTC questionnaires should be complemented with more specific questionnaires when evaluating olfaction and communication in laryngectomized patients.

Development of a clinical instrument improving rehabilitation of olfaction with the Nasal Airflow-Inducing Maneuver in Swedish laryngectomized patients.

CONCLUSION: The protocol is a useful and reliable tool for evaluating the use of the Nasal Airflow-Inducing Maneuver (NAIM) in patients who have undergone total laryngectomy. It facilitates the optimization and improvement of olfactory treatment with NAIM and is sensitive to changes over time. However, further modification of the protocol is needed before a broad implementation into routine clinical practice can be recommended. OBJECTIVES: To develop and assess whether a protocol evaluating NAIM variables is sensitive and reliable to study olfactory function after total laryngectomy. SUBJECTS AND METHODS: Video documentation from 21 laryngectomized patients receiving olfactory rehabilitation during the study period 2002-2005 was used. The patients' execution of NAIM was evaluated using a protocol with identified NAIM variables. Olfactory acuity was tested with the Scandinavian Olfactory Identification Test (SOIT). Data from the first (baseline) and third (after treatment) intervention sessions and from follow-up at 6 and 12 months are reported. RESULTS: According to the NAIM evaluation protocol patients significantly improved their execution of the NAIM technique over time and these improvements were associated with improvements in olfactory acuity (SOIT). Using the protocol important key variables for improvement of the NAIM technique were identified. The inter- and intra-rater reliability for the NAIM evaluation protocol was moderate to good.

A more than 10-year prospective, follow-up study of esophageal and pharyngeal acid exposure, symptoms and laryngeal findings in healthy, asymptomatic volunteers.

OBJECTIVE: To evaluate the development of pharyngeal and esophageal acid exposure, symptoms, and laryngeal findings in previously healthy subjects. MATERIAL AND METHODS: Thirty-three subjects, previously included in a normative pH monitoring study, completed symptom questionnaires, a video laryngoscopic examination, and ambulatory 24-h pharyngeal and esophageal pH monitoring after a mean follow-up of 14 years. RESULTS: Twenty-four subjects (15 F, 9 M, mean age 57 years) completed the study. The number of subjects with pathological esophageal reflux increased from 5 (21%) at baseline to 8 (33%) at follow-up (p=0.23), whereas the proportion with pharyngeal acid exposure of at least 0.1% decreased from 42% to 13% (p=0.04). Heartburn and/or regurgitation developed in 11 of the 24 (46%) subjects and airway symptoms in 10 (42%) subjects. Laryngeal pathology was found in 9 of 23 subjects (39%). Airway symptoms were equally common among subjects with and those without laryngeal findings or with and without pharyngeal reflux. CONCLUSIONS: Esophageal acid exposure increases over time in previously symptom-free, healthy subjects. The increase in airway symptoms or laryngeal abnormalities is not directly related to increased acid exposure.

Effectiveness of olfactory rehabilitation with the nasal airflow-inducing maneuver after total laryngectomy: one-year follow-up study.

OBJECTIVE: To assess the long-term results of the nasal airflow-inducing maneuver in olfaction rehabilitation in patients who had undergone laryngectomy. DESIGN: Prospective interventional study. SETTING: University hospital. PATIENTS: Twenty-four patients who had undergone laryngectomy (21 men and 3 women; mean age, 68 years) who received olfactory rehabilitation with the nasal airflow-inducing maneuver were reevaluated 6 and 12 months after primary treatment. MAIN OUTCOME MEASURE: Olfactory function was tested by means of a semistructured interview; the Questionnaire on Olfaction, Taste and Appetite; and the Scandinavian Odor-Identification Test. Quality of life was measured with the European Organization for Research and Treatment of Cancer QLQ-C30 and QLQ-H&N35 questionnaires. Patients were categorized as smellers or nonsmellers based on results of the Scandinavian Odor-Identification Test. RESULTS: Before treatment, 10 of 24 patients (42%) were smellers and 14 (58%) were nonsmellers. At 6-month follow-up, 20 of 23 patients (87%) were smellers, whereas after 12 months, 21 of 24 patients (88%) were smellers. Long-term olfaction rehabilitation was achieved in 11 of 14 patients (79%) with anosmia, and 15 of all 24 patients (63%) could be classified as having normal olfactory capacity at the end of the study. CONCLUSION: The nasal airflow-inducing maneuver is a patient-friendly, inexpensive, and effective method for restoring the sense of smell in patients after laryngectomy, and the results persist in the long term.