Development and Validation of a Remote Monitoring Tool for Assessment of Mild, Moderate, and Severe Infections in Inflammatory Bowel Disease.

BACKGROUND: Immunomodulators and biologics are cornerstones in the management of inflammatory bowel disease [IBD], but are associated with increased risk of infections. Post-marketing surveillance registries are pivotal to assess this risk, yet mainly focus on severe infections. Data on the prevalence of mild and moderate infections are scarce. We developed and validated a remote monitoring tool for real-world assessment of infections in IBD patients. METHODS: A 7-item Patient-Reported Infections Questionnaire [PRIQ] covering 15 infection categories was developed with a 3-month recall period. Infection severity was defined as mild [self-limiting or topical treatment], moderate [oral antibiotics, antivirals, or antifungals], or severe [hospitalisation or intravenous treatment]. Comprehensiveness and comprehensibility were ascertained through cognitive interviewing of 36 IBD outpatients. After implementation in the telemedicine platform myIBDcoach, a prospective, multicentre cohort study was performed between June 2020 and June 2021 in 584 patients, to assess diagnostic accuracy. Events were cross-checked with general practitioner and pharmacy data [gold standard]. Agreement was evaluated using linear-weighted kappa with cluster-bootstrapping to account for within-patient level correlation. RESULTS: Patient understanding was good and interviews did not result in reduction of PRIQ items. During validation, 584 IBD patients {57.8% female, mean age 48.6 (standard deviaton [SD]: 14.8), disease duration 12.6 years [SD: 10.9]} completed 1386 periodic assessments, reporting 1626 events. Linear-weighted kappa for agreement between PRIQ and gold standard was 0.92 (95% confidence interval [CI] 0.89-0.94). Sensitivity and specificity for infection [yes/no] were 93.9% [95% CI 91.8-96.0] and 98.5% [95% CI 97.5-99.4], respectively. CONCLUSIONS: The PRIQ is a valid and accurate remote monitoring tool to assess infections in IBD patients, providing means to personalise medicine based on adequate benefit-risk assessments.

Symptom Experience and Content Validity of the Psoriasis Symptom Scale (PSS) in Patients with Generalized Pustular Psoriasis (GPP).

INTRODUCTION: We sought to understand key symptoms of generalized pustular psoriasis (GPP) and to confirm the relevance to patients and content validity of the Psoriasis Symptom Scale (PSS) in GPP. METHODS: A targeted literature review and clinical expert interviews were conducted as background research. Patients were interviewed individually (involving concept elicitation and cognitive interviews), and a separate patient workshop was conducted to determine disease-specific symptoms of importance. RESULTS: Seven participants with moderate (n = 4), severe (n = 2), and mild (n = 1) GPP and clinician diagnosis were interviewed. During concept elicitation, all participants indicated that pustules may underlie other symptoms. Symptoms reported by all patients were pain, redness, itch, burning, and discomfort. The PSS symptoms of pain, itching, burning, and redness were reported by ≥ 86% of patients as most frequently experienced. Upon debriefing, the PSS was well understood. Relevance and importance of these symptoms was confirmed in the GPP patient workshop. CONCLUSION: Participant feedback found the PSS measure to be relevant and easy to understand. The symptoms included in the instrument, pain, redness, itch, and burning, were most frequently reported, important, and well understood by patients. Study results provided support for the content validity of the PSS for use as endpoints in GPP clinical trials.

Generalized pustular psoriasis (GPP) is a severe rare disease, including redness and boils that sometimes come with fever and other general symptoms. This study asked patients with GPP about their key symptoms, and whether the Psoriasis Symptom Scale (PSS) is relevant to them as patients. The PSS is a questionnaire with the symptoms pain, itching, burning, and redness. We searched the literature and interviewed clinical experts to guide the patient interviews. Patients were recruited through clinical sites and the National Psoriasis Foundation (NPF). The interviews discussed GPP symptoms and the PSS questionnaire. Patients with GPP were also asked about commonly experienced symptoms in a workshop. Most patients had moderate to severe GPP. Patients in both the interviews and workshop described experiencing pain, redness, itch, burning, and discomfort with their boils. During interviews, the patients said the PSS questionnaire was easy to understand. Patients in the workshop also found the PSS to be relevant and easy to understand. Patients agreed the symptoms in the PSS, pain, redness, itch, and burning, were common and important. Study results support the PSS for use with patients in clinical trials.

Patients with non-idiopathic sudden sensorineural hearing loss show hearing improvement more often than patients with idiopathic sudden sensorineural hearing loss.

INTRODUCTION: To compare inpatient treated patients with idiopathic (ISSNHL) and non-idiopathic sudden sensorineural hearing loss (NISSNHL) regarding frequency, hearing loss, treatment and outcome. METHODS: All 574 inpatient patients (51% male, median age: 60 years) with ISSNHL and NISSNHL, who were treated in federal state Thuringia in 2011 and 2012, were included retrospectively. Univariate and multivariate statistical analyses were performed. RESULTS: ISSNHL was diagnosed in 490 patients (85%), NISSNHL in 84 patients (15%). 49% of these cases had hearing loss due to acute otitis media, 37% through varicella-zoster infection or Lyme disease, 10% through Menière disease and 7% due to other reasons. Patients with ISSNHL and NISSNHL showed no difference between age, gender, side of hearing loss, presence of tinnitus or vertigo and their comorbidities. 45% of patients with ISSNHL and 62% with NISSNHL had an outpatient treatment prior to inpatient treatment (p < 0.001). The mean interval between onset of hearing loss to inpatient treatment was shorter in ISSNHL (7.7 days) than in NISSNHL (8.9 days; p = 0.02). The initial hearing loss of the three most affected frequencies in pure-tone average (3PTAmax) scaled 72.9 dBHL ± 31.3 dBHL in ISSNHL and 67.4 dBHL ± 30.5 dBHL in NISSNHL. In the case of acute otitis media, 3PTAmax (59.7 dBHL ± 24.6 dBHL) was lower than in the case of varicella-zoster infection or Lyme disease (80.11 dBHL ± 34.19 dBHL; p = 0.015). Mean absolute hearing gain (Δ3PTAmaxabs) was 8.1 dB ± 18.8 dB in patients with ISSNHL, and not different in NISSNHL patients with 10.2 dB ± 17.6 dB. A Δ3PTAmaxabs ≥ 10 dB was reached in 34.3% of the patients with ISSNHL and to a significantly higher rate of 48.8% in NISSNHL patients (p = 0.011). CONCLUSIONS: ISSNHL and NISSNHL show no relevant baseline differences. ISSNHL tends to have a higher initial hearing loss. NISSHNL shows a better outcome than ISSNHL.

The clinical, humanistic, and economic burden of palmoplantar pustulosis: a structured review.

Introduction: Palmoplantar pustulosis (PPP) is a chronic, relapsing and refractory disease characterized by sterile pustules appearing on the palms and/or soles, accompanied by erythema, blistering, scales and/or keratinization. The overall burden of PPP in terms of its clinical impact, effect on patients and families, and economic consequences has not previously been investigated in a structured manner.Areas covered: A structured search focused on identification of studies in PPP using specific search terms in PubMed and EMBASE® from 2005 onwards, with additional back-referencing and pragmatic searches. Outcomes of interest included clinical burden, humanistic burden, and economic burden.Expert opinion: In cross-sectional studies, approximately 75% of all PPP patients suffer from active disease, with risk of relapse remaining constant over time. Patients' health-related quality of life is significantly impaired, as expected for a disease affecting hands and feet. Tools have been described that assess the clinical as well as patient-reported burden of PPP; their performance in larger cohorts and/or clinical trials remains to be investigated. The key data limitations identified include inconsistent definitions for characterizing remission/relapse, and limited humanistic and economic burden data; future studies are required to address these evidence gaps.

The clinical, humanistic, and economic burden of generalized pustular psoriasis: a structured review.

Introduction: Generalized pustular psoriasis (GPP) is characterized by widespread erythema and edema, superficial sterile coalescing pustules, and lakes of pus. Although the impact of GPP is thought to be substantial, emerging literature on its clinical, humanistic, and economic burden has not previously been described in a structured way.Areas covered: A structured search focused on the identification of studies in GPP using specific search terms in PubMed and EMBASE® from 2005 onwards, with additional back-referencing and pragmatic searches. Outcomes of interest included clinical, humanistic, and economic burden.Expert opinion: Despite its significant clinical, humanistic, and economic burden, GPP is poorly classified and inadequately studied. A recent European (ERASPEN) consensus classifies GPP into relapsing and persistent disease and classifies patients on the presence or absence of psoriasis vulgaris. Classification of GPP lesions involving >30% body surface area or use of hospitalization as a surrogate may be a way to identify significant flares. Given the frequency of flares, the impaired quality of life during the post-flare period, and safety/tolerability issues, it is clear that current treatment options are not sufficient. Long-term studies utilizing the European consensus statement with subclassifiers are required to supplement our current understanding of the burden of GPP.

Reliability, validity, and the ability to detect change of the Psoriasis Symptom Scale (PSS) in patients with plaque psoriasis.

Introduction: The primary objective of the study was to evaluate the measurement properties of the patient-reported four-item Psoriasis Symptom Scale (PSS).Methods: Analysis of phase-III data on the efficacy of risankizumab to assess psychometric characteristics of the PSS in patients with moderate-to-severe psoriasis.Results: PSS items had a good range of symptom severity coverage. The PSS had good test-retest reliability (ICCs >0.90). Convergent and discriminant validity was indicated by moderate-to-strong correlations between the PSS and Dermatology Life Quality Index (DLQI), PSS pain item and EQ-5D pain/discomfort item at week 12 (0.63), and moderate negative correlation with EQ-Visual Analog Scale score at week 12 (-0.37). Known groups validity demonstrated as mean PSS total scores varied by Psoriasis Area and Severity Index (PASI) and Static Physician's Global Assessment (sPGA) defined groups (p < .0001). PSS total scores were responsive to changes in PASI score (p < .0001) and sPGA (p < .0001). PSS minimal, clinical, and meaningful change is estimated to be 1 to 2 points; a preliminary responder definition is a total change score of 3 to 4 points.Conclusions: The PSS is a short, valid unidimensional measure of psoriasis symptom severity, well suited for use in clinical trials.

Influence of Idiopathic Pulmonary Fibrosis Progression on Healthcare Resource Use.

BACKGROUND: Disease progression and acute exacerbations in patients with idiopathic pulmonary fibrosis (IPF) are associated with high morbidity and mortality. They usually require a visit to a specialist or a general practitioner (GP) in less severe cases or hospitalisation in more severe cases. OBJECTIVE: The objective of this study was to identify factors that influence resource use in IPF. METHODS: Clinical and healthcare resource use data were collected in two large, international, multi-centre, randomised controlled trials (RCTs) that studied nintedanib for the treatment of IPF (INPULSIS-1 and -2). The pooled data of nintedanib and placebo included 1014 patients followed for 12 months. The trial data were analysed in 3-month intervals. We studied two dependent variables: the occurrence of all-cause hospitalisation and visits to a physician (GP or specialist). The independent variables included the change in forced vital capacity percent predicted (FVC%pred), investigator-reported acute exacerbation events, age, time since diagnosis, smoking status, and sex. RESULTS: Hospitalisation during a 3-month interval was significantly associated with a drop of at least 5 or 10 points in FVC%pred (odds ratios [ORs] 1.58 [p = 0.009] and 2.62 [p < 0.001]) and associated with the occurrence of at least one acute exacerbation (OR 14.44; p < 0.001) during the same interval. The above factors remained significant when repeating the analysis for hospitalisation based on change in FVC%pred or events occurring during the previous 3 months interval. Smoker status and a unit change in FVC%pred during the previous interval were added to the significant factors. Physician visits during a 3-month interval were significantly associated with a lower FVC%pred at the start of the interval (per 10-point decrement, OR 1.05; p = 0.040) and with the change in FVC%pred during the same interval (per 10-point loss, OR 1.13; p = 0.042). Visits were also associated with a 5-point drop in FVC%pred (OR 1.23; p = 0.020), age (per 5-year increments OR 1.07; p = 0.028), and female sex (OR 1.32; p = 0.017). Nevertheless, the predictive power of the models was considered poor for both outcomes (hospitalisation and physician visits). CONCLUSIONS: Disease progression and acute exacerbation events are significantly associated with hospitalisation of patients with IPF. Outpatient visits to physicians are associated with disease progression, baseline FVC%pred, age and sex.

[Management of vestibular schwannomas]. / Management des Vestibularisschwannoms.

Vestibular schwannomas are benign neoplasms originating from the Schwann cells of the vestibular vestibular nerve of the vestibulocochlear nerve, and rarely from the pars cochlearis. These are tumors that are in contact with the nerve but do not bind the fibers. Benign neoplasms of the Schwann cells of the auditory and equilibrium nerves can also occur primarily in the inner ear and are referred to as intralabyrinthine schwannomas (ILS). Vestibular schwannomas represent 6-7 % of all intracranial and 90 % of cerebellopontine angle tumors. Bilateral occurrence occurs in < 5 % of cases, and then corresponds to type 2 neurofibromatosis. The first symptom is often a unilateral hearing loss. It may then lead to balance disorders, tinnitus, facial paralysis and other impairments. Diagnosis is audiological, vestibular and imaging. Magnetic resonance imaging currently represents the gold standard. Management chooses between an observational strategy and surgery, depending on tumor size, age, and other factors. The possible access routes offer different advantages and disadvantages; the potential complications include the liquorrhoea. Radiation therapy is possible in special cases, and drug therapies are also being tested. In the rehabilitation of the hearing function, in addition to a CROS or BICROS restoration, the cochlear implant has been used with good success. The impact on quality of life is largely determined by hearing impairment, balance disorders, tinnitus, and possibly headache, which must be considered in patient consultation and long-term care.

Psychometric properties of the St George's Respiratory Questionnaire in patients with idiopathic pulmonary fibrosis: insights from the INPULSIS trials.

INTRODUCTION: We evaluated the psychometric properties of the St George's Respiratory Questionnaire (SGRQ) in patients with idiopathic pulmonary fibrosis (IPF) using data from the two INPULSIS trials. METHODS: Data from 1061 patients treated with nintedanib or placebo were pooled. Internal consistency, test-retest reliability, construct validity, known-groups validity, responsiveness and responder thresholds were examined. RESULTS: Cronbach's α was 0.93 for SGRQ total score and >0.75 for domain scores. In patients with stable disease based on change in forced vital capacity (FVC) ≤5% predicted or 'no change' on Patient's Global Impression of Change, intraclass correlation coefficients for the SGRQ total score were 0.72 or 0.76, respectively. Moderate to strong correlations were observed between SGRQ total and domain scores and the Cough and Sputum Assessment Questionnaire cough domains (-0.34 to -0.65), University of California San Diego Shortness of Breath Questionnaire (0.56 to 0.83) and EuroQol 5-Dimensional Quality of Life Questionnaire Visual Analogue Scale (-0.41 to -0.55); correlations with FVC % predicted were weak (-0.24 to -0.30). Longitudinal correlations between changes in SGRQ total score and these patient-reported outcomes over 52 weeks were moderate. Changes in SGRQ total, impact and activity scores were sensitive to detecting improvement or deterioration in FVC >10% predicted at week 52. Collectively, distribution-based and anchor-based approaches suggested using a change of 4-5 points in SGRQ total score as a starting point for responder analyses. CONCLUSIONS: The psychometric properties of the SGRQ support its use as a measure of health-related quality of life in patients with IPF.

Inpatient treatment of patients with idiopathic sudden sensorineural hearing loss: a population-based healthcare research study.

PURPOSE: The aim was to determine inpatient treatment rates of idiopathic sudden sensorineural hearing loss (ISSNHL) with focus on diagnostics, treatment, and outcome. METHODS: A retrospective population-based study in the federal state Thuringia in 2011 and 2012 was performed on all 490 inpatients (51% females, median age: 60 years) treated for ISSNHL (Median duration: 7 days). The association between analyzed parameters and the probability of recovery was tested using univariable and multivariable statistics. RESULTS: The inpatient treatment rate for ISSNHL was 11.23 per 100,000. 172 patients (35%) had an outpatient treatment prior to inpatient treatment. For pure-tone audiometry of the three most affected frequencies (3PTAmax), the initial median hearing loss was 66.67 dB, the median absolute hearing gain ΔPTAabs was 10.0 dB, and the median relative hearing gain in relation with the contralateral side ΔPTArel contral was 30.86%. 51% of the patients reached a ΔPTAabs of ≥ 10 dB. About 2 of 5 patients recovered to a ΔPTArel contral ≥ 50% or reached ≤ 10 dB of contralateral ear. The multivariate analysis revealed that an ISSNHL on the left side [Hazard ratio (HR) = 1.6.88; confidence interval (CI) = 1.161-2.454], no down-sloping audiogram type (HR = 2.016; CI = 1.391-2.921), and no prior outpatient prednisolone treatment (HR = 2.374; CI = 1.505-3.745) were independent factors associated with better recovery (ΔPTAabs ≥ 10 dB). CONCLUSION: Inpatient treatment of ISSNHL is variable in daily practice. The population-based recovery rate was worse than reported in clinical trials. More standardization and clearer criteria for outpatient, inpatient, and salvage therapy are needed.

Humanistic and cost burden of systemic sclerosis: A review of the literature.

BACKGROUND: Systemic sclerosis (SSc), or systemic scleroderma, is a chronic multisystem autoimmune disease characterised by widespread vascular injury and progressive fibrosis of the skin and internal organs. Patients with SSc have decreased survival, with pulmonary involvement as the main cause of death. Current treatments for SSc manage a range of symptoms but not the cause of the disease. Our review describes the humanistic and cost burden of SSc. METHODS: A structured review of the literature was conducted, using predefined search strategies to search PubMed, Embase, and the Cochrane Library. Grey literature searches also were conducted. RESULTS: In total, 2226 articles were identified in the databases and 52 were included; an additional 10 sources were included from the grey literature. The review identified six studies reporting relevant cost estimates conducted in five different countries and four studies that assessed the humanistic burden of SSc. Total direct annual medical costs per patient for Europe varied from €3544 to €8452. For Canada, these costs were reported to be from Can$5038 to Can$10,673. In the United States, the total direct health care costs were reported to be US$17,365 to US$18,396. Different key drivers of direct costs were reported, including hospitalisations, outpatients, and medication. The total annual costs per patient were reported at Can$18,453 in Canada and varied from €11,074 to €22,459 in Europe. Indirect costs represented the largest component of the total costs. EQ-5D utility scores were lower for patients with SSc than those observed in the general population, with reported mean values of 0.49 and 0.68, respectively. The average value of the Health Assessment Questionnaire for patients with SSc was significantly higher than the control population (0.94), and the average value of the SF-36 was significantly lower than the control population: 49.99 for the physical dimension and 58.42 for the mental dimension. CONCLUSIONS: Overall, there is a paucity of information on the burden of SSc. Nonetheless, our review indicates that the quality of life of patients with SSc is considerably lower than that of the general population. In addition, SSc places a considerable economic burden on health care systems and society as a whole.

Inpatient Treatment of Patients Admitted for Dizziness: A Population-Based Healthcare Research Study on Epidemiology, Diagnosis, Treatment, and Outcome.

OBJECTIVE: To determine inpatient treatment rates of patients with dizziness with focus on diagnostics, treatment and outcome. STUDY DESIGN: Retrospective population-based study. SETTING: Inpatients in the federal state Thuringia in 2014. PATIENTS: All 1,262 inpatients (62% females, median age: 61 yr) treated for inpatient dizziness were included. MAIN OUTCOME MEASURES: The association between analyzed parameters and probability of improvement and recovery was tested using univariable and multivariable statistics. RESULTS: Final diagnosis at demission was peripheral vestibular disorder (PVD), central vestibular disorder (CVD), cardiovascular syndrome, somatoform syndrome, and unclassified disease in 75, 9, 3, 0.6, and 13%, respectively. The most frequent diseases were acute vestibular neuritis (28%) and benign paroxysmal positional vertigo (22%). The follow-up time was 38 ±â€Š98 days. 88.5% of patients showed at least an improvement of complaints and 31.4% a complete recovery. The probability for no improvement from inpatient dizziness was higher if the patient had a history of ear/vestibular disease (hazard ratio [HR] = 1.506; 95% confidence interval [CI] = 1.301-1.742), and was taking more than two drugs for comorbidity (HR = 1.163; CI = 1.032-1.310). Compared with final diagnosis of cardiovascular syndrome, patients with PVD (HR = 1.715; CI = 1.219-2.415) and CVD (HR = 1.587; CI = 1.076-2.341) had a worse outcome. CONCLUSIONS: Inpatient treatment of dizziness was highly variable in daily practice. The population-based recovery rate was worse than reported in clinical trials. We need better ways to implement clinical trial findings for inpatients with dizziness.

Using one filter stage of unsaturated/saturated vertical flow filters for nitrogen removal and footprint reduction of constructed wetlands.

French vertical flow constructed wetlands (VFCW) treating raw wastewater have been developed successfully over the last 30 years. Nevertheless, the two-stage VFCWs require a total filtration area of 2-2.5 m2/P.E. Therefore, implementing a one-stage system in which treatment performances reach standard requirements is of interest. Biho-Filter® is one of the solutions developed in France by Epur Nature. Biho-Filter® is a vertical flow system with an unsaturated layer at the top and a saturated layer at the bottom. The aim of this study was to assess this new configuration and to optimize its design and operating conditions. The hydraulic functioning and pollutant removal efficiency of three different Biho-Filter® plants commissioned between 2011 and 2012 were studied. Outlet concentrations of the most efficient Biho-Filter® configuration are 70 mg/L, 15 mg/L, 15 mg/L and 25 mg/L for chemical oxygen demand (COD), 5-day biological oxygen demand (BOD5), total suspended solids (TSS) and total Kjeldahl nitrogen (TKN), respectively. Up to 60% of total nitrogen is removed. Nitrification efficiency is mainly influenced by the height of the unsaturated zone and the recirculation rate. The optimum recirculation rate was found to be 100%. Denitrification in the saturated zone works at best with an influent COD/NO3-N ratio at the inflet of this zone larger than 2 and a hydraulic retention time longer than 0.75 days.

The accuracy of objective threshold determination at low frequencies: comparison of different auditory brainstem response (ABR) and auditory steady state response (ASSR) methods.

OBJECTIVE: The hearing threshold at 500 Hz was estimated using five methods which are suitable for the low frequency range: Low-Chirp BERA (LCBERA), Notched-noise BERA (NNBERA), Narrow band CE-Chirp BERA (NBCBERA) and Narrow band CE-Chirp ASSR (NBCASSR) (40/90 Hz). The slope of the discrimination function of each method was used for determination of the most efficient method. The threshold values were compared and the corresponding odds ratios (OR) were calculated. DESIGN: All methods were applied to each subject. Stimulus levels were arranged individually. Response detection was carried out by visual inspection of the records in case of BERA and automatically in case of ASSR. Each individual series of recordings was converted to a dichotomous function indicating whether or not a response was discernible and a continuous method-specific discrimination function was constructed. This function was realised by a Boltzmann function whose slope in the inflection point serves as quality measure. Additionally, an OR evaluation was carried out in order to validate the significance of results. STUDY SAMPLE: Twenty five normal hearing adults (aged 18-30 years) were tested. RESULTS: LCBERA proved to have the highest reliability according to the slope of the Boltzmann function, the comparison of threshold values and OR. CONCLUSIONS: The LCBERA is recommended for use in routine clinical practice.

[Direct Microlaryngoscopy: A Population-Based Analysis on Outcome, Complications and Surgery Rates]. / Mikrolaryngoskopie: Eine populationsbezogene Analyse zu Outcome, Komplikationen und Operationsraten.

Although microlaryngoscopy is an integral part of surgical routine of otorhinolaryngologists, there is no population-based data published on surgery rates and efficiency of microlaryngoscopy country-wide or nation-wide. All 616 patients who underwent microlaryngoscopy 2011 in one of the eight ENT departments in Thuringia were analyzed according to patients' characteristics, therapy, complications and follow-up. The majority of admissions were performed because of a benign disease (60%) of the larynx, and in 33% related to a malignant disease or suspicion of a malignant disease. When a benign disease was suspected, it was confirmed 98% of cases. When a malignant tumor was suspected, it was confirmed in 51% of cases, i. e. ruled out in 49% of cases. Transient laryngeal edema (22%) and bleeding needing revision surgery (1%) were the most frequent or serve observed postoperative sequelae. Teeth damage occurred only in 2 cases (0.2%). A recurrence of the primary disease was observed in 14%. Longer surgery time was an independent predictor for postoperative bleeding and for postoperative laryngeal edema (p=0.050 and p=0.013, respectively). Revision surgery (p<0.0001) and a final diagnosis of a malignant disease (p=0.017) were independent predictors for recurrence of the primary disease. The overall incidence of microlaryngoscopy was 22.98/100000 population. The highest incidence was seen for patients 50-59 years of age with 39.76/100000. Benign diseases were the most frequent indication with 19.33/100000. This population-based analysis is showing that microlaryngoscopy is performed effectively and with low postoperative risks in daily routine of otorhinolaryngologists.

Evaluation of optimal masking levels in place-specific low-frequency chirp-evoked auditory brainstem responses.

The aim of the study is the experimental determination of the optimal required masking level for a given stimulus level when using a band limited "low-frequency chirp" in order to improve frequency and place specificity of auditory brainstem responses (ABRs). A low-frequency chirp (100-850 Hz) at stimulation levels between 40 and 80 dB normalized hearing level was presented to 12 normal hearing subjects. During presentation of each stimulus, the level of a high-pass noise with a low cutoff frequency of 1100 Hz was varied between 0 and 25 dB signal-to-noise ratio (SNR) by using 5 dB steps (at 0 dB SNR the same level of both the chirp and the masker in dB sound pressure level was presented). Measurements without masking were used as a reference. In all masking conditions, the latency of wave V was significantly increased compared to unmasked ABRs. The amplitude of wave V decreased when reaching the effective and therefore optimal masking level. Accordingly, in order to ensure place specificity of the ABR, ipsilateral masking is essential. At lower stimulus levels the SNR can be substantially increased (i.e., the masker level decreased) without loss of place specificity.

Psychometric properties of the St George's Respiratory Questionnaire in patients with idiopathic pulmonary fibrosis.

The St George's Respiratory Questionnaire (SGRQ) has been used to measure health-related quality of life (HRQoL) in patients with idiopathic pulmonary fibrosis (IPF).This analysis evaluated the psychometric properties of the SGRQ using data from 428 patients with IPF who participated in a 12-month, randomised, placebo-controlled phase II trial of nintedanib.Internal consistency (Cronbach's α) was 0.91 for SGRQ total and >0.70 for domain scores. Test-retest reliability (intraclass correlation coefficients) was 0.77, 0.77, 0.69 and 0.66 for SGRQ total, activity, impact and symptoms scores, respectively. Construct validity of SGRQ total and domain scores was supported by weak to moderate cross-sectional correlations with the Medical Research Council dyspnoea scale (0.32-0.55), 6-min walk test distance (-0.25- -0.34), percentage predicted forced vital capacity (-0.11- -0.15) and measures of gas exchange (-0.26-0.03). There was some evidence that the SGRQ total score was sensitive to detecting change.The reliability, construct validity and responsiveness of the SGRQ in patients with IPF suggest that this is an acceptable measure of HRQoL in patients with IPF.

Role of comorbidity on outcome of head and neck cancer: a population-based study in Thuringia, Germany.

To examine the impact of comorbidity on overall survival (OS) in a population-based study of patients with head and neck cancer who were treated between 2009 and 2011. Data of 1094 patients with primary head and neck carcinomas without distant metastasis from the Thuringian cancer registries were evaluated concerning the influence of patient's characteristics and comorbidity on OS. Data on comorbidity prior to head and neck cancer diagnosis was adapted to the Charlson Comorbidity (CCI), age-adjusted CCI (ACCI), head and neck CCI (HNCCI), simplified comorbidity score (SCS), and to the Adult Comorbidity Evaluation-27 (ACE-27). Most patients were male (80%; median age: 60 years; 50% stage IV tumors). Smoking, alcohol abuse, and anemia were registered for 38%, 33%, and 23% of the patients, respectively. Predominant therapy was surgery + radiochemotherapy (30%), surgery (29%), and surgery + radiotherapy (21%). Mean CCI, ACCI, HNCCI, SCS and ACE-27 were 1.0 ± 1.5, 2.6 ± 2.1, 0.6 ± 0.8, 4.4 ± 4.2, and 0.9 ± 0.9, respectively. Median follow-up was 25.7 months. Multivariable analyses showed that higher age, higher UICC stage, no therapy, including surgery or radiotherapy, alcohol abuse, and anemia, higher comorbidity were independent risk factors for worse OS (all P < 0.05). According to the discriminatory power analysis none of the five comorbidity scores was superior to the other scores to prognosticate OS. This population-based study showed that comorbidity is frequent in German patients with head and neck cancer and is an important risk factor for poor OS. Comorbidity should be routinely assessed and taken into account in prospective clinical trials.