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Objective: The aims of this study were to adapt the Swedish version of the International Outcome Inventory for Hearing Aids (IOI-HA) to the International Outcome Inventory for Alternative Interventions (IOI-AI) in the context of ear surgery (IOI-AI op ) and to test the psychometric properties., Design: The validated Swedish questionnaire IOI-HA was adapted to the IOI-AI op by omitting the question about hearing aid use and changing the term "hearing aid" to "surgery" in the remaining items. The validity, component structure and reliability of the IOI-AI op were assessed., Study Sample: Subjects diagnosed with otosclerosis and undergoing stapedotomy were included in the study (n = 162)., Results: High mean scores were noted for all items. Ceiling effects were noted, most pronounced for the satisfaction item. Principal component analysis (PCA) yielded a two-component structure explaining 77.5% of the variance. The test-retest reliability measured by intra class correlation coefficient was >0.9, and the internal consistency coefficient measured by Cronbach's alfa was >0.8., Conclusion: The IOI-AI op showed good psychometric properties. However, ceiling effects were observed. The two-component solution was in line with previous factor analyses of the IOI-HA and the IOI-AI. The comprehensive IOI-AI op is recommended as a useful tool to evaluate patient perspectives after ear surgery.

Objectives: This study aims to report on the effectiveness of voice rehabilitation following radiotherapy for laryngeal cancer in a long-term perspective, i.e., up to three years after completion of radiotherapy., Methods: The study included a total of 74 patients that were randomised into an intervention group ( n  = 37) or a control group ( n  = 37). Voice recordings with blinded assessment of voice quality with the GRBAS protocol (Grade, Roughness, Breathiness, Asthenia, Strain) and acoustic analysis was performed at baseline, 12 and 36 months following radiotherapy. Voice rehabilitation was performed in 10 sessions immediately following completion of radiotherapy. Patients also filled out the Swedish Self-Evaluation of Communication Experiences after Laryngeal cancer., Results: The S-SECEL demonstrated statistically significant improvements in the intervention group when comparing baseline and 36 months, and no changes in the control group. Acoustic measures did not reveal any significant changes. The perceptual analysis demonstrated that when comparing the changes within the groups between baseline and 36 months there were statistically significant differences between the intervention and control group regarding the voice qualities Roughness, Breathiness and Strain. In the control group, 50% demonstrated deterioration in roughness, while in the intervention group only 7% deteriorated during this time. In Breathiness and Strain, 57 and 50%, respectively, improved in the intervention group, while only 32% and 23% improved, respectively, in the control group., Conclusion: Voice rehabilitation following radiotherapy for laryngeal cancer demonstrate positive effects in patient reported outcomes and perceptual measures of voice quality, and the effects remain up to three years following radiotherapy.

Background: Symptoms are essential in the clinical diagnosis of gastro-esophageal reflux disease (GERD). Questionnaires such as GerdQ have been developed as diagnostic aids. GerdQ has been thoroughly validated in well-characterized GERD patients, but has not yet been fully evaluated in a population that includes subjects with atypical symptoms., Aim: To evaluate GerdQ in a population with typical and/or atypical symptoms of GERD, defined by 24-h pH monitoring. The secondary aim was to investigate the outcome of GerdQ depending on the response to proton pump inhibitor (PPI) treatment., Methods: The study included 646 subjects referred for 24-h pH monitoring due to a clinical suspicion of GERD. All subjects completed GerdQ before performing a 24-h pH monitoring., Results: In total, 377 (58%) subjects were diagnosed with GERD based on symptoms and 24-h pH monitoring (GERD pH ). Of these, 46% had atypical main symptoms. Overall, GerdQ (at cut-off 8) predicted GERD pH with a sensitivity and specificity of 62% and 74%, respectively. A high specificity but poor sensitivity for diagnosis of GERD pH was found for atypical main symptoms such as cough, dysphagia and globus. GerdQ had a relatively high sensitivity and specificity in predicting PPI response and a PPV of 99% at cut-off 8., Conclusions: GerdQ has a diagnostic value in an unselected population presenting with typical and/or atypical symptoms of GERD, but a low sensitivity for diagnosis of GERD pH was found in subjects with predominant symptoms such as cough, dysphagia and globus.

Objectives: The study aimed to investigate the effects of voice rehabilitation on health-related quality of life (HRQL) and voice function in patients treated for laryngeal cancer six months post-rehabilitation completion. A secondary aim was to identify factors that predict significant communication improvement., Study Design: Longitudinal follow-up of randomised controlled trial., Methods: In total, 33 patients received voice rehabilitation post-radiotherapy and 32 patients constituted the control group. Outcome measures included patient-reported HRQL, communication and voice function (acoustic measures and perceptual analysis). Outcome measures were analysed one (baseline), six and 12 months post-radiotherapy, where voice rehabilitation was conducted between the first two time-points., Results: Patients improved after voice rehabilitation with regard to communication function and HRQL and remained unchanged after 12 months post-radiotherapy. A significant roughness deterioration in the control group occurred between six and 12 months post-radiotherapy, yet remained unchanged in the intervention group. A factors increasing odds of significant communication improvement 12 months post-radiotherapy was voice rehabilitation. Smoking affected communication negatively., Conclusion: Voice rehabilitation appears to have positive effect on voice function and HRQL, which persist up to 12 months of follow-up and appears to prevent deterioration of perceived roughness. Patients who experience voice and communication problems at baseline are most likely to benefit from voice rehabilitation.

Background This study aims to investigate the long-term effects of structured trismus intervention in patients with head and neck cancer (HNC) and trismus in terms of mouth opening, trismus-related symptoms and health-related quality of life (HRQL). Material and methods Fifty patients with HNC to receive radiotherapy ± chemotherapy were included in this prospective study along with a matched control group. The intervention group received a 10-week structured exercise with a jaw mobilizing device (TheraBite® jaw device or Engström device). Patients were assessed before and after trismus exercise intervention and at a two-year follow-up. Primary endpoint was maximum interincisal opening (MIO) and secondary endpoints included trismus-related symptoms and HRQL assessed with patient-reported outcome (PRO)-instruments [Gothenburg Trismus Questionnaire (GTQ), European Organization for Research and Treatment of Cancer Core Questionnaire (EORTC QLQ-C30) and the related HNC-specific module the EORTC Head & Neck Questionnaire (EORTC QLQ-H&N35)]. Results The intervention group had a higher MIO at the two-year follow-up compared to the control group (40.5 mm and 34.3 mm, respectively), which was statistically significant. The intervention group also reported less jaw-related problems according to the GTQ and higher functioning as measured by EORTC QLQ-C30 and QLQ-H&N35 compared to the control group. Conclusion A positive persistent effect of exercise intervention for trismus in HNC patients was found with regard to MIO, trismus-related symptoms and HRQL. Exercise intervention is important in long-term treatment of radiation-induced trismus in HNC patients. The trismus-specific questionnaire, GTQ, is a valuable tool for observing and evaluating trismus over time.

Background To investigate potential changes in perceptual, acoustic and patient-reported outcomes over 12 months for laryngeal cancer patients treated with radiotherapy. Material and methods A total of 40 patients with Tis-T3 laryngeal cancer treated with curative intent by radiotherapy were included in this prospective longitudinal descriptive study. Patients were followed pre-radiotherapy, one month, six months and 12 months post-radiotherapy, where voice recordings and patient-reported outcome instruments (European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core30, Head and Neck35, Swedish Self-Evaluation of Communication Experiences after Laryngeal Cancer) were completed at each appointment. Perceptual analysis, using the Grade-Roughness-Breathiness-Asthenia-Strain scale and vocal fry parameters, and acoustic measures including harmonics-to-noise ratio (HNR), jitter, shimmer and mean spoken fundamental frequency (MSFF) were produced from voice recordings. Results All patients presented with dysphonic voices pre-radiotherapy, where 95% demonstrated some degree of vocal roughness. This variable improved significantly immediately post-radiotherapy, however, then deteriorated again between six and 12 months. Vocal fry also increased significantly at 12 months. Acoustic measures were abnormal pre- and post-treatment with no significant change noted except for MSFF, which lowered significantly by 12 months. Health-related quality of life (HRQL) deteriorated post-radiotherapy but returned to pretreatment levels by 12 months. Conclusion By 12 months, most perceptual, acoustic, patient-reported voice and HRQL outcomes for laryngeal cancer patients treated by radiotherapy had showed no significant improvements compared to pretreatment function. Further studies are required to investigate potential benefits of voice rehabilitation following radiotherapy.

Objective: This study aims to assess the effect of voice rehabilitation on health-related quality of life (HRQL) and communication experience for laryngeal cancer patients treated with radiotherapy., Method: This prospective randomised controlled trial included 74 patients with Tis-T4 laryngeal cancer treated curatively by radiotherapy, of which 37 constituted the intervention group receiving voice rehabilitation and 37 patients as a control group. Patients were followed at one and six months post-radiotherapy, with voice rehabilitation conducted between these time-points. Endpoints included patient reported outcomes, including HRQL as measured by European Organisation for Research and Treatment of Cancer (EORTC) Core30 (C30) and Head & Neck35 (H&N35) as well as communication function as measured by Swedish Self-Evaluation of Communication Experiences after Laryngeal cancer (S-SECEL)., Results: The intervention group reported statistically significant improvements in communication experience as measured by S-SECEL environmental, attitudinal and total score domains compared to the control group. Similar improvements were seen in EORTC H&N35 Speech domain and the EORTC C30 domain Global quality of life. Moderate correlations were noted (r = 0.51-0.59) between three of four S-SECEL domains and the EORTC domains Speech and Global quality of life., Conclusion: Laryngeal cancer patients treated with radiotherapy who receive voice rehabilitation appear to experience beneficial effects on communication function and selected HRQL domains. Voice rehabilitation following radiotherapy is recommended but further research investigating potential target groups and long-term effects is required.

Background: To provide further information about short-term effects on voice quality and health-related quality of life (HRQL) following radiotherapy for laryngeal cancer, comparing glottic and supraglottic tumours., Material and Methods: Sixty-seven male patients who received radiotherapy for glottic and supraglottic tumours were included. Voice recordings were performed and patient reported outcome questionnaires filled in before radiotherapy and one-month post-completion. Acoustic and temporal measures were produced from the recordings and compared to an age-matched, vocally healthy control group (n = 23)., Results: Deterioration of HRQL post-radiotherapy was noted for both the glottic and supraglottic cohort. Pre- radiotherapy the glottic cohort demonstrated acoustic and temporal measures that were statistically different from healthy controls, with improvements post-radiotherapy where several measures showed no statistically significant differences compared to healthy controls. The supraglottic cohort revealed voice measures comparable to the healthy controls but demonstrated statistically significant impairments in HRQL compared to the glottic cohort following radiotherapy., Conclusion: Patients with supraglottic tumours may experience more eating and swallowing related problems prior to radiotherapy compared to glottic tumours and demonstrate a more significant reduction in HRQL following treatment. However, in terms of voice measurements, subjective measures correlate poorly with objective acoustic parameters, thereby emphasising the importance of patient-reported outcomes as part of treatment evaluation.

Background: The aim of this study was to investigate the impact of structured exercise with jaw mobilizing devices on trismus and its effect on trismus symptomatology and health-related quality of life (HRQL) in head and neck (H&N) cancer patients., Material and Methods: Fifty patients with H&N cancer and trismus, i.e. maximum interincisal opening (MIO) ≤ 35 mm participated in a structured intervention program with jaw exercise. The patients in the intervention group underwent a 10-week exercise program with regular follow-up. A control group comprising of 50 patients with trismus and H&N cancer were matched to the intervention group according to gender, tumor location, tumor stage, comorbidity and age. HRQL and trismus-related symptoms were assessed., Results: The mean MIO improvement was 6.4 mm (4.8-8.0) and 0.7 (-0.3-1.7) mm in the intervention group and control group respectively, three months post-intervention commencement (p < 0.001). The intervention group demonstrated a statistically significant improvement in Role functioning, Social functioning and Global quality of life (EORTC QLQ C30) and in all Gothenburg Trismus Questionnaire (GTQ) domains, i.e. jaw-related problems (p < 0.001), eating limitation (p < 0.05) and muscular tension (p < 0.001)., Conclusion: We found that a structured jaw exercise program was effective and improved the mouth opening capacity significantly. The objective effect on trismus (MIO) was also reflected in the patient-reported outcome questionnaires where the patients who underwent the structured exercise program after cancer treatment reported improvements in HRQL and less trismus-related symptoms compared to the control group.

Background: Trismus is a common symptom related to the treatment of head and neck (H&N) cancer. To date there are few prospective studies regarding the incidence of trismus and the patients' experience of trismus in daily life activities. The aim of the study was to assess the incidence of trismus in H&N cancer patients and the impact on health-related quality of life (HRQL), by evaluating the patients before and after oncological treatment., Material and Methods: We used the criteria for trismus of maximum interincisal opening (MIO) ≤ 35 mm and measured the patients at several occasions before and after treatment during one year. The patients answered the HRQL questionnaires EORTC QLQ C30, EORTC QLQ H&N 35, Gothenburg Trismus Questionnaire (GTQ) and the Hospital Anxiety and Depression Scale (HADS)., Results: The incidence of trismus was 9% pre-treatment and 28% at the one-year follow-up post-treatment. The highest incidence, 38%, was found six months post-treatment. Patients with tumours of the tonsils were most prone to develop trismus. Patients with trismus reported greater HRQL impairments with regard to the GTQ domains; mouth opening (p < 0.001), jaw-related problems (p < 0.05), eating limitations (p < 0.05) and muscular tension (p < 0.001) six months post-treatment. EORTC QLQ H&N 35 scores indicated clinically significantly more problems with dry mouth, swallowing and pain for patients with trismus, 6-12 months post-treatment. Furthermore, all patients reported pain, anxiety and depression pre- and post-treatment., Conclusion: The incidence of trismus in patients with H&N cancer is non-negligible. Trismus severely impairs HRQL and negatively affects daily life activities in patients with H&N cancer. Further studies regarding symptomatic treatment of patients with trismus are highly warranted. The symptom-specific questionnaire GTQ is useful to identify the problems in this group of patients given it is responsive to showing change over time.

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.

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.

Objective: The clinically used cut-off limit in reflux disease is pH 4. Yet, earlier studies have shown a poor correlation between pharyngeal reflux episodes and symptoms or laryngeal findings, and treatment results have been suboptimal. Moreover, recent data suggest that pepsin is still active at pH 5. The aim of this study was to evaluate the occurrence of pharyngeal pH 5 reflux episodes in healthy controls and to correlate these to the pH monitoring results with a cut-off limit of pH 4., Material and Methods: The results of double-probe 24-h pH monitoring from 35 healthy controls were reanalysed concerning the occurrence of pH decreases to pH 5., Results: Pharyngeal pH 5 reflux episodes occurred in 32 healthy controls (91%). The median number of pharyngeal reflux episodes at pH 5 was 4.0. The vast majority of these reflux episodes (92%) occurred in the upright position, especially in the postprandial period. The median time pH < 5 in the pharynx was 0.1% while the upper limit of normality was 1.5%. Pharyngeal pH 5 reflux episodes were 5 times more common than pH 4 reflux episodes. There was a significant positive correlation between hypopharyngeal and oesophageal acid exposure time at both pH 4 and 5 (p<0.01)., Conclusions: Pharyngeal pH 5 reflux episodes are present in most healthy adults, mainly in upright position and in the postprandial period. The importance of these episodes for the occurrence of laryngeal symptoms and signs and for treatment response needs to be prospectively assessed.

Objective: To evaluate the occurrence and changes over time of upper gastrointestinal symptoms in adult subjects randomly recruited from the general population., Material and Methods: A questionnaire recording of upper gastrointestinal symptoms with a 10-year follow-up was carried out in a random sample of the adult population of Göteborg. The original sample, from 1986, comprised 441 subjects within the age span of 20-79 years. In total, 337 subjects participated in the index assessment, of which 197 (95 F) subsequently answered the second questionnaire 10 years later., Results: A majority of the responders (159/197, 83%) reported no change in their global assessment of symptoms. Neither the point prevalence nor the severity for any symptom changed significantly over time. The prevalence of heartburn and acid regurgitation was 25 and 22%, respectively, and the corresponding yearly incidence was estimated to be 1.8 and 1.2%. The main predictor for the occurrence of symptoms of moderate to severe degree at follow-up was the presence of the same symptom 10 years previously. Age or gender per se did not significantly influence the occurrence of symptoms. Changes in body mass index and anti-reflux medication co-varied with the severity of the symptoms heartburn and acid regurgitation., Conclusions: Oesophageal symptoms are common in the adult Swedish population and seem to be fairly stable over time.

A prospective longitudinal study was performed to investigate the sensitivity to change over time of the Swedish Self-Evaluation of Communication Experiences after Laryngeal Cancer questionnaire (S-SECEL), addressing communication dysfunction in patients with laryngeal cancer. Twenty-six consecutive patients attending a weekly tumour conference over a period of one year at Sahlgrenska University Hospital were included in the study prior to start of treatment. The patients answered four questionnaire repeatedly in the course of one year: the S-SECEL, the European Organization for Research and Treatment of Cancer (EORTC), the Core Quality of Life Core Questionnaire (QLQ-C30) supplemented by the Head and Neck cancer questionnaire module (QLQ-H&N35), and the Hospital Anxiety and Depression (HAD) scale. In addition, performance status was assessed. The S-SECEL questionnaire was well accepted by the patients, and compliance was satisfactory with a cumulative response rate of 88% at one year, supporting its feasibility in clinical settings. Repeated measures with the S-SECEL over one year demonstrated a significant decrease in voice and speech dysfunction. The correlation pattern over time between the S-SECEL and the EORTC and HAD questionnaires lent support to the construct validity of the S-SECEL and indicated that the questionnaire was sensitive to clinical change. The changes in S-SECEL correlated most strongly with changes in the EORTC QLQ-H&N35 speech scale, moderately with changes in the QLQ-C30 role and emotional functioning and global QoL scales, while the weakest correlations were with changes in physical functioning. The S-SECEL was sensitive to changes in communication dysfunction, with convergent and discriminant validity of longitudinal assessments, and with relevance for the quality of life of patients with laryngeal cancer receiving different treatment modalities.

A psychometric evaluation of the questionnaire 'Self-Evaluation of Communication Experiences after Laryngeal Cancer' (S-SECEL) addressing communication dysfunction in patients with laryngeal cancer was carried out. Ninety-three patients with laryngeal cancer were studied. For comparison of response patterns and external validation, 21 patients with non-small cell lung cancer (NSCLC) and 26 patients with hoarseness, caused by benign laryngeal disease, were included in the analysis. The patients completed three questionnaires; the S-SECEL, the Sickness Impact Profile (SIP) and the Hospital Anxiety and Depression scale (HAD). The S-SECEL questionnaire was well-accepted by the patients, compliance was satisfactory, and missing value rates were low. The reliability of the S-SECEL was satisfactory for the Environment and Attitude subscales, whereas the General subscale did not reach the reliability levels recommended for group comparisons. In general, the response pattern in the three diagnostic groups and the pattern of correlations between the S-SECEL scores and the SIP- and HAD-subscales and dimensions lent support to the construct validity of the S-SECEL.