Validation of the Swedish Dynamic Imaging Grade of Swallowing Toxicity for Flexible Endoscopic Evaluation of Swallowing (DIGEST-FEES).

In the head and neck cancer (HNC) population around 45% suffer from chronic swallowing difficulties after cancer treatment. Previously a measure for flexible endoscopic evaluation of swallowing (FEES) where swallowing efficiency, safety and overall ability is evaluated within the same framework has been lacking. The Dynamic Imaging Grade of Swallowing Toxicity for FEES (DIGEST-FEES) was developed in 2021 and provides such a measure for patients with HNC. The aim of this study was to translate and validate the DIGEST-FEES into Swedish (Sw-DIGEST-FEES). A translation of the protocol to Swedish was done through forward-backward translation. Two raters rated eighty-nine FEES recordings according to the Sw-DIGEST-FEES and five reference measures of swallowing ability: Yale Pharyngeal Residue Severity Rating Scale, Swallowing Performance Scale, Murray Secretion Scale, MD Anderson Dysphagia Inventory and Penetration Aspiration Scale. Intra- and interrater reliability was analyzed. Construct validity was evaluated by correlating the Sw-DIGEST-FEES ratings to the reference measures. A priori hypothesis was that the correlations would correspond to those of the reference measures included in the original English version. The Sw-DIGEST-FEES demonstrated retained psychometric properties. Construct validity was good. 79% of correlations to the reference measures were equal to or stronger than those in the original development. Inter-rater agreement of the Sw-DIGEST-FEES ranged from substantial to almost perfect (0.76-0.81). Intra-rater reliability was in general almost perfect (0.8-1). The Sw-DIGEST-FEES can be considered a valid and reliable protocol for use in evaluation of swallowing function in HNC patients.

Prevalence of Dysphagia and Risk of Malnutrition in Elderly Living in Nursing Homes.

Swallowing difficulties commonly co-occur with malnutrition in the elderly. However, there is no consensus on which assessment tools to use, and thus reported prevalence varies. The aim of this study was to survey the prevalence of dysphagia and risk of malnutrition in elderly people in nursing homes, evaluate the possible associations between swallowing function and malnutrition and survey whether there were associations between self-perceived function and the results of a screening of dysphagia. A total of 35 residents (aged 67-100 years old) without serious cognitive impairment in the general wards of two nursing homes in Gothenburg were investigated. Swallowing ability was assessed with the Gugging Swallowing Screen (GUSS) test, self-rated swallowing ability with the 4QT and the Swedish Eating Assessment Tool-10 (S-EAT-10) and risk of malnutrition with the Minimal Eating Observation and Nutrition Form-Version 2 (MEONF-II). Eleven participants (31.4%) exhibited dysphagia according to the GUSS and 10 participants (29.4%) showed moderate or high risk of malnutrition. In total 16 (46%) participants reported abnormal swallowing on 4QT and 14 (40%) participants reported abnormal swallowing on S-EAT-10. However, less than half of these had dysphagia according to the GUSS. No association was found between swallowing ability measured by the GUSS and risk of malnutrition, although a tendency towards a weak association was noted, or self-rated swallowing ability measured by the 4QT and S-EAT-10. The study found that approximately one-third of the tested participants presented with signs of dysphagia as measured with the screening instrument GUSS, even though only a few were known to have any difficulties prior to testing. This highlights that dysphagia is probably more prevalent than patients themselves and caregivers are aware of, thus, screening is of importance, to enable safer nutritional intake.

Long-term effects on swallowing and laryngeal function after treatment for severe COVID-19 disease in intensive care.

PURPOSE: This study aimed to assess swallowing and laryngeal function at long-term follow-up in patients treated for severe COVID-19 in the ICU. METHODS: Thirty-six patients with severe COVID-19 were prospectively examined with fiberendoscopic evaluation of swallowing (FEES) about 6 and 12 months after ICU discharge. Comparison with initial FEES examinations during the time in hospital was performed in 17 patients. Analysis of swallowing function and laryngeal features was performed from video recordings. Twenty-five participants responded to Eating Assessment Tool, Voice Handicap Index, and the Hospital Anxiety and Depression Scale at follow-up. RESULTS: Penetration to the laryngeal vestibule (PAS ≥ 3) was seen in 22% and silent aspiration (PAS = 8) in 11% of patients on at least one swallow at follow-up. Fourteen percent had obvious residue in the vallecula and/or pyriform sinuses after swallowing thick liquid or biscuits. Self-reported eating and swallowing difficulties were found in 40% of patients. Abnormal findings in the larynx were present in 53% at follow-up. Thirty-three percent had reduced or impaired vocal fold movement, of whom 22% had bilateral impaired abduction of the vocal folds. Possible anxiety and depression were found in 36% and 24% of responders, respectively. CONCLUSION: Although a majority of patients appear to regain normal swallowing function by 1 year after treatment for severe COVID-19, our results indicate that dysphagia, abnormal laryngeal function, and anxiety/depression may remain in a substantial proportion of patients. This suggests that swallowing and laryngeal function, and emotional symptoms, should be followed up systematically over time in this patient group.

Postradiation trismus in head and neck cancer survivors: a qualitative study of effects on life, rehabilitation, used coping strategies and support from the healthcare system.

PURPOSE: This study aimed to explore the experiences of head and neck cancer (HNC) survivors with postradiation trismus, specifically how oncological treatment affected their lives, rehabilitation, use of coping strategies, and healthcare experiences. METHODS: A qualitative descriptive approach was used and semi-structured interviews of 10 HNC survivors with postradiation trismus were conducted 6-30 months after completing oncological treatment. The interviews were transcribed verbatim and analyzed by qualitative content analysis. RESULTS: The analysis of interviews yielded four main categories: Bodily symptoms, Effects on life, Support from the healthcare system, and Strategies to handle life and symptoms. Participants reported ongoing problems with xerostomia, dysgeusia, eating, and limited physical fitness. Pain related to trismus was not a major issue in this cohort. Participants expressed limitations in their social lives due to their eating difficulties, yet a sense of thankfulness for life and overall satisfaction with the healthcare they received. Psychological and practical coping strategies developed by the participants were also revealed. CONCLUSION: The results highlight areas of unmet need among HNC survivors that healthcare providers can target by establishing multi-professional teams dedicated to individualizing post-cancer rehabilitation care.

Trismus in head and neck cancer: translation and validation of the Chinese version of the Gothenburg Trismus Questionnaire-2 (C-GTQ-2).

OBJECTIVES: Trismus, marked by restricted mouth opening, significantly affects patients with temporomandibular disorder (TMD) and head and neck cancer (HNC). Despite its prevalence, specialized questionnaires for trismus assessment are scarce. This study aims to fill this gap by translating and validating the Gothenburg Trismus Questionnaire version 2 (GTQ-2) into Chinese (C-GTQ-2), enhancing the evaluation of trismus in HNC and TMD patients. MATERIALS AND METHODS: The study involved 78 HNC patients, 75 TMD patients, and a control group of 150 individuals without trismus symptoms. Participants were asked to complete the C-GTQ-2 and other health-related quality of life (HRQL) instruments. A subset of 30 individuals retook the questionnaire within two weeks to assess test-retest reliability. RESULTS: The C-GTQ-2 demonstrated remarkable reliability, with Cronbach's alpha values exceeding 0.70 in three of the four domains, indicating high internal consistency. The instrument also showcased high intra-class correlations in the test-retest, affirming its reliability. Furthermore, it exhibited strong convergent validity, aligning well with other HRQL instruments, and effectively discriminated between patients with and without trismus, establishing its discriminant validity. CONCLUSIONS: The C-GTQ-2 emerges as a valid and reliable tool for assessing trismus in HNC and TMD patients, promising to significantly enhance both clinical and research approaches to managing trismus-related complications in the Chinese-speaking demographic. CLINICAL RELEVANCE: C-GTQ-2 proves effective for trismus assessment in head and neck cancer and temporomandibular disorder patients, offering enhanced clinical and research utility.

A translation and validation of the French version of the Gothenburg Trismus Questionnaire 2 (F-GTQ-2).

BACKGROUND: Limitation of mouth opening, widely known as trismus, is a major symptom altering quality of life in individuals presenting from temporomandibular joint disorder or head and neck cancer. A French-language instrument addressing jaw opening limitation following treatment for head and neck cancer (HNC) or temporomandibular joint disorder (TMD) is lacking. OBJECTIVE: The aim of this study was to translate and validate the Gothenburg Trismus Questionnaire-2 (GTQ-2) into French. METHODS: A French translation of the GTQ-2 was performed according to established international guidelines, leading to the French-GTQ-2 (F-GTQ-2). The validation study included 154 participants with trismus (minimum interincisal opening of ≤35 mm) following treatment for TMD or HNC and 149 age-matched participants without trismus. All participants completed the F-GTQ-2 and participants with trismus completed additional health-related quality of life questionnaires to allow for analysis of convergent validity. RESULTS: The F-GTQ-2 demonstrated retained psychometric properties with Cronbach's alpha values above 0.70 for the domains, jaw-related problems, eating limitations, facial pain and somewhat lower for muscular tension (0.60). Mainly moderate correlations were found when comparing the F-GTQ-2 to other instruments, which was in line with the pre-specified hypotheses, indicating satisfactory convergent validity. Discriminant validity was found with statistically significant differences in all domains of the F-GTQ-2 between trismus and non-trismus participants. CONCLUSION: The F-GTQ-2 can be considered a reliable and valid instrument to assess jaw-related difficulties in individuals with trismus due to HNC or TMD.

Trismus, health-related quality of life, and trismus-related symptoms up to 5 years post-radiotherapy for head and neck cancer treated between 2007 and 2012.

PURPOSE: Radiotherapy-induced trismus is present in up to 40% of patients treated radiotherapeutically for head and neck cancer (HNC) and impacts health-related quality of life (HRQL) negatively. This prospective study aimed to investigate the development of trismus and its influence on HRQL and trismus-related symptoms in HNC patients for up to 5 years post-radiotherapy completion as no such follow-up studies exist. METHODS: Patients (n = 211) were followed prospectively from pre-radiotherapy to 12 and 60 months post-radiotherapy. At each follow-up, maximum interincisal opening (MIO) was measured, and patients filled in the European Organization for Treatment of Cancer Quality-of-Life Questionnaire Core-30 (EORTC QLQ-C30), Head and Neck-35 (EORTC QLQ-HN35), and Gothenburg Trismus Questionnaire (GTQ). Trismus was defined as an MIO ≤ 35 mm. RESULTS: At 1 year post-radiotherapy, a total of 27% met the trismus criterion, and at 5 years post-radiotherapy, the corresponding figure was 28%. Patients in the trismus group scored significantly worse compared to the patients without trismus on 8/15 domains at 1 year post-radiotherapy on EORTC QLQ-C30, further worsening in 11/15 domains at 5 years post-radiotherapy. Similar results were found for EORTC QLQ-HN35. Patients with trismus reported more trismus-related symptoms according to the GTQ at both timepoints compared to those without trismus. CONCLUSION: This study highlights that HNC patients suffering from radiotherapy-induced trismus report poorer HRQL and more trismus-specific symptoms compared to patients without trismus. These differences persist and increase up to at least 5 years following treatment completion. Hence, our results highlight that radiotherapy-induced trismus affects long-term HRQL, jaw symptoms, and pain, further stressing the need for early and structured intervention.

Facial pain, health-related quality of life and trismus-related symptoms up to 5 years post-radiotherapy for head and neck cancer.

PURPOSE: Pain is a frequent symptom of head and neck cancer (HNC) but longitudinal studies investigating facial pain are scarce. We aimed to investigate prevalence of facial pain, its effect on health-related quality of life (HRQL) and trismus-related symptoms in a HNC cohort. METHODS: Patients (n = 194) were prospectively followed post completion of radiotherapy (RT). Outcome measures included facial pain, HRQL, trismus-specific symptoms, and maximal interincisal opening (MIO). RESULTS: Facial pain was reported by 50% at baseline. Corresponding figures for 3-, 12-, and 60 months post-RT were 70%, 54% and 41%. Moderate to severe pain was reported in 29-44% of patients reporting pain during the study period. Patients reporting pain scored significantly worse on more HRQL variables and trismus symptoms, as well as had significantly smaller MIO at all follow-up time points. CONCLUSIONS: Facial pain was common in HNC patients pre- and post-RT and remained prevalent up to 5 years after completion of RT. Reductions in MIO were associated with more facial pain. Pain was also associated with worse HRQL.

A 5-year prospective study of health-related quality of life in irradiated head and neck cancer patients: three trends of HRQL over time.

PURPOSE: Head and neck cancer (HNC) is one of the fastest increasing cancer-types, where both disease and oncologic treatment have severe impact on health-related quality of life (HRQL). This study aimed to report HRQL prospectively up to 5-years following radiotherapy-treatment in HNC and to, if possible, identify trends in HRQL over time. METHODS: This prospective study followed 211 patients receiving curatively intended radiotherapy pre-diagnosis, 3-, 6-, 12- and 60-months post-radiotherapy completion. HRQL was measured using EORTC QLQ-C30 and EORTC QLQ-HN35. RESULTS: A deterioration three months post-radiotherapy was reported in 14/15 domains of EORTC QLQ-C30. Eight out of 12 domains had recovered to baseline-values at 12 months post-radiotherapy and remained unchanged up to study endpoint. Corresponding figures for EORTC QLQ-HN35 were deteriorations in 15/16 domains at three months post-radiotherapy, with recovery of 5 domain at 12-months, whereas the other 11 domains remained significantly worse at 5-years post-RT compared to baseline. CONCLUSION: Following the deterioration in HRQL seen immediately following radiotherapy, the continued course of HRQL can be divided into three trends: short-term deterioration, long-term deterioration and long-term improvements. The combination of disease- and diagnosis-specific questionnaires is crucial when assessing HRQL in the HNC population.

A randomized controlled study evaluating the head-lift exercise in head and neck cancer patients with radiation-induced dysphagia: effect on swallowing function and health-related quality of life over 12 months.

PURPOSE: Dysphagia is common after radiotherapy for head and neck cancer (HNC) and can affect health-related quality of life (HRQL). This randomized controlled trial aimed to evaluate the effect of the head-lift exercise (HLE) over 12 months in HNC patients with radiation-induced dysphagia. METHODS: Sixty-one patients with dysphagia were randomized to intervention group (n = 30) and control group (n = 31) at 6-36 months after completion of radiotherapy for HNC. Dysphagia-specific HRQL was measured with the MD Anderson Dysphagia Inventory (MDADI); general and HNC-specific HRQL was measured with the European Organization for Research and Treatment of Cancer Quality of Life questionnaire Core 30 (EORTC QLQ-C30) and QLQ-H&N35. Measurements were made at baseline, and at 8 weeks and 12 months after start of intervention. RESULTS: Adherence to the intervention was good throughout the year. When comparing change from baseline reports to each follow-up no statistically significant differences between the groups were found in any of the HRQL instruments. There were some statistically significant changes within groups compared to baseline. The intervention group improved self-rated swallowing function on the MDADI at 8 weeks (emotional domain, p = 0.03; functional domain, p = 0.007; total score, p = 0.01) and the control at twelve months (emotional domain, p = 0.03; functional domain, p = 0.02; physical domain, p = 0.004; total score, p = 0.002). CONCLUSION: In this randomized control study, no effect was observed short term or at 12 months on HRQL after use of the HLE as rehabilitation for radiation-induced dysphagia.

Effect of voice rehabilitation following radiotherapy for laryngeal cancer - a 3-year follow-up of a randomised controlled trial.

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.

Treatment with head-lift exercise in head and neck cancer patients with dysphagia: results from a randomized, controlled trial with flexible endoscopic evaluation of swallowing (FEES).

BACKGROUND: This randomized study aimed to evaluate the effects of the Shaker head-lift exercise (HLE) to improve dysphagia following oncologic treatment for head and neck cancer (HNC). METHODS: Patients with dysphagia following oncologic treatment for HNC were randomly assigned to intervention (n = 23) or control (standard dysphagia management, n = 24) groups. Swallowing was evaluated at baseline and at 8-week follow-up using flexible endoscopic evaluation of swallowing (FEES) and self-perceived swallowing with the Eating Assessment Tool (EAT-10). Analysis was performed regarding secretion, initiation of swallow, residue after swallowing, and penetration/aspiration. RESULTS: Few statistically significant differences were found in the FEES analysis. Some improvement of self-perceived swallowing function was found in both groups. Adherence to training was high. CONCLUSIONS: This randomized study regarding the effect of the HLE demonstrated that swallowing outcome measures used in assessment of FEES did not improve in patients treated with radiotherapy for patients with dysphagia following HNC.

Validation of the Swedish Watson Dysphagia Scale for adult patients with eosinophilic esophagitis.

BACKGROUND: The Swedish Watson Dysphagia Scale (S-WDS) has been used to assess dysphagia in patients with eosinophilic esophagitis (EoE) but has not been validated for this patient group. The aim of this study was to validate the S-WDS for adult patients with EoE. METHODS: Ninety-seven Swedish adult patients with EoE and 97 controls without dysphagia filled out the S-WDS, the Swedish Eosinophilic Esophagitis Activity Index (S-EEsAI) and a set of supplementary questions. The reliability of the S-WDS was evaluated using Cronbach's alpha, Pearson correlation of items and total score, and test-retest analysis (n = 29). Validity was investigated using Spearman correlations of the S-WDS items, S-EEsAI domains and a self-assessment score, and by investigating floor and ceiling effects. RESULTS: The Cronbach's alpha of the S-WDS was 0.77 and all items demonstrated moderate to strong correlation to the S-WDS score (r = 0.40-0.81) indicative of sufficient reliability of the instrument. In addition, the test-retest results reflected excellent reliability with an intraclass correlation coefficient of 0.85 for the S-WDS score. Adequate validity of the instrument was demonstrated, the S-WDS score correlated moderately with the self-assessment score and with 4/6 S-EEsAI domains, and strongly with the remaining two domains. Floor effects were more common for liquids and soft-textured foods and ceiling effects increased with increasing food consistency. The S-WDS scores of the patient group were significantly different from those of the nondysphagia control group (P < 0.001). CONCLUSION: The S-WDS instrument is an appropriate and valid instrument for assessment of dysphagia in patients with EoE.

Patient-Reported Dysphagia in Adults with Eosinophilic Esophagitis: Translation and Validation of the Swedish Eosinophilic Esophagitis Activity Index.

The lack of a Swedish patient-reported outcome instrument for eosinophilic esophagitis (EoE) has limited the assessment of the disease. The aims of the study were to translate and validate the Eosinophilic Esophagitis Activity Index (EEsAI) to Swedish and to assess the symptom severity of patients with EoE compared to a nondysphagia control group. The EEsAI was translated and adapted to a Swedish cultural context (S-EEsAI) based on international guidelines. The S-EEsAI was validated using adult Swedish patients with EoE (n = 97) and an age- and sex-matched nondysphagia control group (n = 97). All participants completed the S-EEsAI, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Oesophageal Module 18 (EORTC QLQ-OES18), and supplementary questions regarding feasibility and demographics. Reliability and validity of the S-EEsAI were evaluated by Cronbach's alpha and Spearman correlation coefficients between the domains of the S-EEsAI and the EORTC QLQ-OES18. A test-retest analysis of 29 patients was evaluated through intraclass correlation coefficients. The S-EEsAI had sufficient reliability with Cronbach's alpha values of 0.83 and 0.85 for the "visual dysphagia question" and the "avoidance, modification and slow eating score" domains, respectively. The test-retest reliability was sufficient, with good to excellent intraclass correlation coefficients (0.60-0.89). The S-EEsAI domains showed moderate correlation to 6/10 EORTC QLQ-OES18 domains, indicating adequate validity. The patient S-EEsAI results differed significantly from those of the nondysphagia controls (p < 0.001). The S-EEsAI appears to be a valid and reliable instrument for monitoring adult patients with EoE in Sweden.

The prevalence and symptoms of temporomandibular disorders in head and neck cancer patients.

OBJECTIVES: This retrospective patient survey aimed to assess the prevalence of temporomandibular disorders (TMD) before and after curative oncological treatment and to identify possible risk factors. MATERIALS AND METHODS: Patients with squamous cell carcinoma in the tonsil or base of the tongue were included (n = 217). Medical records were collected to assess TMD prevalence before oncological treatment and at 6- and 12-month follow-up. Fisher's test and Pitman's test were used. RESULTS: Significantly reduced mouth opening was observed after oncological treatment at 6- and 12-month follow-up (p < .001). Symptoms from the temporomandibular joint and jaw muscles plus pain upon palpation (p = .0083, p < .001, respectively) and self-reported pain upon chewing (<0.001) and opening the mouth (<0.001) increased 12 months following radiotherapy. Pain and degree of mouth opening prior to treatment, self-reported depression, overall health status, brachytherapy and jaw exercise during radiotherapy were factors affecting the increase of TMD symptoms. CONCLUSION: All TMD symptoms escalated significantly one year after radiotherapy except self-reported sounds from the temporomandibular joint. Reduction in the degree of mouth opening and pain in the jaw muscles and the temporomandibular joint when opening the mouth and upon chewing were commonly reported symptoms following radiotherapy. Several potential risk factors were identified.

Quality of care in dysphagia patients: adaptation and validation of the Swedish SWAL-CARE questionnaire.

BACKGROUND: The aim of this study was to adapt the instrument and evaluate the psychometric properties of the Swedish version of the Swallowing Quality of Care questionnaire (S-SWAL-CARE) in patients with oropharyngeal dysphagia. METHODS: Translation and adaptation of the original SWAL-CARE into Swedish was performed according to established international guidelines. Field testing was performed using 100 patients with oropharyngeal dysphagia due to multiple reasons such as head and neck cancer and neurologic/neuromuscular disease, who had undergone swallowing evaluation within 6 months prior to the study. The patients answered the S-SWAL-CARE, the Quality from the Patient's Perspective (QPP) and the Swallowing Quality of Life (SWAL-QOL). Test-retest was performed in 20% of the participants. The reliability and validity of the S-SWAL-CARE were assessed by Pearson correlation coefficient and Cronbach's alpha as well as convergent and discriminative validity, respectively. RESULTS: The field testing of the S-SWAL-CARE resulted in sufficient reliability, with Cronbach's alpha values exceeding 0.90 for all domains. All items correlated strongly to their own domain, with weaker correlations to the other domains, indicating proper scale structure. Results also indicate sufficient convergent and discriminant validity when tested for association to the QPP domains and the SWAL-QOL Total score. The test-retest reliability of the S-SWAL-CARE demonstrated sufficient intraclass correlation coefficient (ICC) for the General advice domain (0.73) and Clinical advice domain (0.82). The ICC for the Patient satisfaction domain was lower (0.44). CONCLUSION: The S-SWAL-CARE can be considered a reliable and valid tool to assess the dysphagia-related quality of care in a mixed Swedish dysphagia patient population.

Cost-effectiveness analysis of voice rehabilitation for patients with laryngeal cancer: a randomized controlled study.

INTRODUCTION: Voice problems are common following radiotherapy for laryngeal cancer. Few studies exist covering the effect of voice rehabilitation, and no previous studies exist regarding the cost of said rehabilitation. This randomized controlled study aimed to analyze the cost-effectiveness of voice rehabilitation after radiotherapy for patients with laryngeal cancer. MATERIAL AND METHODS: A total of 66 patients with laryngeal cancer with follow-up data 12 months post-radiotherapy were included. Patients were randomized into receiving either voice rehabilitation (n = 32) or no voice rehabilitation (n = 34). The patient outcome was measured as quality-adjusted life years (QALYs). The index range between 0 and 1, where 0 equals death and 1 represents perfect health. The QALYs were assessed with the European Organization for Research and Treatment of Cancer questionnaire QLQ-C30 mapped to EuroQoL 5 Dimension values. The cost of rehabilitation and other healthcare visits was derived from hospital systems. The patients reported the total amount of sick leave days during the first 12 months following radiotherapy. The cost-effectiveness of the voice rehabilitation was compared with no rehabilitation intervention based on the incremental cost-effectiveness ratio. RESULTS: The cost per gained QALY with voice rehabilitation compared to no rehabilitation from a societal perspective was - 27,594 € (SEK - 250,852) which indicates that the voice rehabilitation is a cost-saving alternative compared to no rehabilitation due to lower costs and a slightly better health outcome. From a healthcare perspective, the voice rehabilitation indicates a cost 60,800 € (SEK 552,725) per gained QALY. CONCLUSION: From a societal perspective, i.e., including the costs of production loss, voice rehabilitation compared to no voice rehabilitation following radiotherapy for laryngeal cancer seems to be cost-saving. When analyzing only the healthcare costs in relation to health outcomes, voice rehabilitation indicates an incremental cost of 60,800 € per gained QALY, which is just above the threshold of the maximum willingness to pay level.

Macular Atrophy in the HARBOR Study for Neovascular Age-Related Macular Degeneration.

PURPOSE: To evaluate macular atrophy (MA) presence in the 24-month HARBOR study (NCT00891735) for neovascular age-related macular degeneration (AMD). DESIGN: Post hoc analysis of a phase 3 multicenter, prospective, randomized, double-masked, active treatment-controlled clinical trial. PARTICIPANTS: Evaluable subjects (N = 1095) with subfoveal choroidal neovascularization (CNV) secondary to neovascular AMD treated with ranibizumab 0.5 mg or 2.0 mg monthly or pro re nata (PRN). METHODS: Fluorescein angiograms (FAs) and color fundus photographs at baseline and months 3, 12, and 24 were retrospectively graded by masked graders for MA: well-defined areas of depigmentation with increased choroidal vessel visibility, diameter ≥250 µm, corresponding to flat areas of well-demarcated staining on FA, excluding atrophy associated with retinal pigment epithelium tears. Atrophy immediately within, adjacent, and nonadjacent to CNV lesions was included. MAIN OUTCOME MEASURES: Macular atrophy incidence, best-corrected visual acuity (BCVA). RESULTS: At baseline, MA was detected in 11.2% (123/1095) of study eyes. At month 24, 29.4% (229/778) of eyes without baseline atrophy had detectable MA. Eyes with and without baseline MA had significant mean BCVA gains from baseline at month 24 (letters [95% confidence interval]: +6.7 [4.1-9.3]; +9.1 [8.0-10.2], respectively). Among eyes with and without MA at month 24, mean month 24 BCVA was 62.0 [60.3-63.7] and 64.7 [63.2-66.3] letters, respectively. Baseline risk factors for month 24 MA presence included intraretinal cysts (hazard ratio [HR], 2.45 [1.76-3.42]) and fellow eye atrophy (HR, 2.02 [1.42-2.87]); subretinal fluid was associated with a lower MA risk (HR, 0.50 [0.33-0.74]). Ranibizumab dose was not associated with MA development. Monthly versus PRN treatment trended toward an association with MA (HR, 1.29 [0.99-1.68]), but was not statistically significant. CONCLUSIONS: New MA was detected in 29% of study eyes after 24 months of treatment. Clinically significant BCVA gains were achieved with MA present over 24 months. Baseline subretinal fluid absence, intraretinal cyst presence, and fellow eye atrophy presence were associated with month 24 MA presence. With existing data, the benefits of ranibizumab for neovascular AMD outweighed the risk of MA development over 24 months in HARBOR, although outcomes >2 years were not evaluated.