Using Lower Amplitudes to Maintain Effective High Dose Spinal Cord Stimulation Therapy (SCS Dosing Pilot Study).

BACKGROUND: Spinal cord stimulation is an effective therapy for chronic back and/or leg pain. Amplitude dose-response studies are lacking; therefore, little guidance exists regarding the minimum amplitude requirements with specific high dose parameters. This study characterized the minimum amplitude level that maintained SCS therapy satisfaction and pain relief when stimulating at 1000 Hz and 90 µsec. MATERIALS AND METHODS: Qualified patients had back and leg pain, an implanted neurostimulator programmed to 1000 Hz and 90 µsec, and were very or somewhat satisfied with the therapy, and an average overall VAS pain score ≤ 4 from a daily diary. Patients received four blinded amplitudes (titrated from 80%, 60%, 40%, and 20% of baseline perception threshold), approximately two weeks each, with 1000 Hz and 90 µsec and position-adaptive stimulation enabled. Patients' satisfaction and overall VAS pain scores were collected for each period. All patients continued through the study, even after reporting lack of therapy satisfaction or pain relief. RESULTS: The minimum amplitude, which maintained therapy satisfaction, was 80% of perception threshold for two patients, 60% for one patient, and 20% for 21 patients. Additionally, six patients lost satisfaction changing from their baseline amplitude to 80% perception threshold. The minimum amplitude level, which maintained overall pain relief, was 80% perception threshold for three patients, 60% perception threshold for one patient, 40% perception threshold for two patients, and 20% perception threshold for 19 patients. Five patients required the setting they were programmed to during the baseline period. CONCLUSION: The qualified study patients defined an implanted population reporting good pain relief and satisfaction using HD SCS therapy at baseline. The majority of these patients were able to maintain therapy satisfaction and pain relief (70% and 63.3%, respectively) with 20% perception threshold amplitude. Amplitudes below perception threshold could potentially maintain effective SCS therapy with HD stimulation in a subset of patients.

Effect of continuous positive airway pressure on maximal exercise capacity in patients with obstructive sleep apnea: a systematic review and meta-analysis.

STUDY OBJECTIVES: Exercise capacity is impaired in obstructive sleep apnea (OSA). There are conflicting reports on the effect of continuous positive airway pressure (CPAP) on maximal exercise capacity. The objective of this review was to determine if there is a change in exercise capacity and anaerobic threshold following CPAP treatment in OSA patients. METHODS: We conducted a systematic review and meta-analyses to summarize the changes in peak rate of oxygen uptake (V̇O2 peak) or maximum rate of oxygen uptake (V̇O2 max) and anaerobic threshold (AT) during cardiopulmonary exercise testing following CPAP intervention in patients with OSA. A systematic literature review was conducted to identify published literature on markers of V̇O2 peak, V̇O2 max, and AT pre- vs post-CPAP using a web-based literature search of PubMed/MEDLINE, Embase, CINAHL, and Cochrane review (CENTRAL) databases. Two independent reviewers screened the articles for data extraction and analysis. RESULTS: The total search of all the databases returned 470 relevant citations. Following application of eligibility criteria, 6 studies were included in the final meta-analysis for V̇O2 peak, 2 studies for V̇O2 max, and five studies for AT. The meta-analysis showed a mean net difference in V̇O2 peak between pre- and post-CPAP of 2.69 mL·kg-1·min-1, P = .02, favoring treatment with CPAP. There was no difference in V̇O2 max or AT with CPAP treatment (mean net difference 0.66 mL·kg-1·min-1 [P = .78] and -144.98 mL·min-1 [P = .20] respectively). CONCLUSIONS: There is a paucity of high-quality studies investigating the effect of CPAP on exercise capacity. Our meta-analysis shows that V̇O2 peak increases following CPAP treatment in patients with OSA, but we did not observe any change in V̇O2 max or AT. Our findings should be considered preliminary and we recommend further randomized controlled trials to confirm our findings and to clarify the peak and maximum rates of oxygen uptake adaptations with CPAP therapy.

Preemptive pharmacogenetic testing: exploring the knowledge and perspectives of US payers.

PURPOSE: Preemptive pharmacogenetic testing aims to optimize medication use by having genetic information at the point of prescribing. Payers' decisions influence implementation of this technology. We investigated US payers' knowledge, awareness, and perspectives on preemptive pharmacogenetic testing. METHODS: A qualitative study was conducted using semistructured interviews. Participants were screened for eligibility through an online survey. A blended inductive and deductive approach was used to analyze the transcripts. Two authors conducted an iterative reading process to code and categorize the data. RESULTS: Medical or pharmacy directors from 14 payer organizations covering 122 million US lives were interviewed. Three concept domains and ten dimensions were developed. Key findings include clinical utility concerns and limited exposure to preemptive germ-line testing, continued preference for outcomes from randomized controlled trials, interest in guideline development, importance of demonstrating an impact on clinical decision making, concerns of downstream costs and benefit predictability, and the impact of public stakeholders such as the Food and Drug Administration and Centers for Medicare and Medicaid Services. CONCLUSION: Both barriers and potential facilitators exist to developing cohesive reimbursement policy for pharmacogenetics, and there are unique challenges for the preemptive testing model. Prospective outcome studies, more precisely defining target populations, and predictive economic models are important considerations for future research.

Differences in the Intended Meaning of Congestion Between Patients and Clinicians.

Importance: Disagreement in the presumed meaning of common medical terms may impair communication between patients and caregivers. Objective: To clarify the intended meaning of the term congestion among otolaryngology clinic patients and to identify discrepancies in definitions between patients and otolaryngologists. Design, Setting, and Participants: In this cross-sectional survey study from an otolaryngology clinic at an academic center, a semantics-based questionnaire was provided to consecutive new patients during intake for a clinical encounter from December 2016 through February 2017, and to 31 otolaryngologists and 28 nonotolaryngologist physicians in February 2018. Respondent definitions for congestion were selected from a list of 16 proposed terms covering 4 general categories. Main Outcome and Measures: Symptom categories for term used to describe congestion by patients and clinicians. Results: Among 226 patient respondents (133 female [58.8%]; mean [SD] age, 54 [15.6] years), the most commonly selected definitions for congestion were from the obstructive (199; 88.1%) and mucus-related (196; 86.7%) symptom categories. More than 1 general category was selected by 208 patients (92.0%), whereas 11 patients (4.9%) described congestion only in terms of mucus-related symptoms. Definitions were limited to upper respiratory tract symptoms by 83 (36.7%) patients and lower respiratory tract symptoms by 2 (0.9%) patients. Among 31 otolaryngologists, congestion was most frequently defined in terms of obstructive symptoms (difference, 11.9%; 95% CI, 7.4%-16.5%). In contrast, patients more often described congestion in terms of pressure-related (difference, 38.8%; 95% CI, 7.5%-70.1%) or mucus-related (difference, 51.2%; 95% CI, 22.6%-79.9%) symptoms. A total of 22 otolaryngologists (71.0%) defined congestion using 1 to 4 symptoms, compared with only 69 patients (30.5%). Conclusions and Relevance: The definition of congestion appears to be highly variable and ambiguous for many patients. Moreover, the findings suggest that patients and otolaryngologists generally do not describe congestion using the same terms.

An evaluation of the psychometric properties of the sf-12v2 health survey among adults with hemophilia.

BACKGROUND: This study examined the psychometric properties of version 2 of the SF-12 Health Survey (SF-12v2) among adults with hemophilia in the United States. METHODS: This study employed a cross-sectional design using web-based and paper-based self-administered surveys. Hemophilia patients were recruited using an online panel and at a hemophilia treatment clinic. The psychometric properties of the SF-12v2 were assessed in terms of construct validity, internal consistency reliability, and presence of floor and ceiling effects. RESULTS: A total of 218 adults with hemophilia completed the survey, with most recruited via the online panel (78%). Confirmatory factor analysis using the WLSMV estimator in Mplus supported a two-factor model for the SF-12v2 where the physical functioning, role physical, bodily pain, and general health items loaded onto a latent physical factor (LPF) and the role emotional, mental health, social functioning, and vitality items loaded onto a latent mental factor (LMF). Model fit statistics for the two-factor model were: Chi-square [df] = 172.778 [48]; CFI = 0.972; TLI = 0.962; RMSEA [90% CI] = 0.109 [0.092-0.127]; WRMR = 0.947. Correlated residuals for items belonging to similar domains were estimated and there was a significant correlation between LPF and LMF. All standardized factor loadings were strong and statistically significant, indicating adequate convergent validity. Item-to-other scale correlations were lower than item-to-hypothesized scale correlations suggesting good item discriminant validity. Model testing revealed that LPF and LMF were not perfectly correlated, suggesting adequate construct discriminant validity. Increasing levels of symptom severity were associated with significant decreases in physical component summary (PCS) and mental component summary (MCS) scores, supporting known-groups validity. Internal consistency reliability was satisfactory, with Cronbach's alpha of 0.848 for the LPF and 0.785 for the LMF items. Finally, none of the participants received the least or maximum possible PCS or MCS score, indicating the absence of floor and ceiling effects. CONCLUSIONS: Overall, the SF-12v2 was found to have adequate psychometric validity in our sample of adults with hemophilia. These results add to the growing evidence of psychometric validity of the SF-12v2 in different patient populations including hemophilia.

Eagle Syndrome Secondary to Osteoradionecrosis of the Styloid Process.

BACKGROUND: Eagle syndrome is a rare condition caused by elongation of the styloid process or ossification of the stylohyoid ligament. The symptomatology can be vague but may include dysphagia, odynophagia, otalgia, foreign body sensation, facial pain, trismus, headache, tinnitus, increased salivation, and/or voice changes. CASE REPORT: We present the case of a 58-year-old male believed to have acquired Eagle syndrome secondary to osteoradionecrosis of the styloid process following radiation therapy used as adjuvant treatment for a surgically resected pT2N1M0 squamous cell carcinoma of the right tonsil. CONCLUSION: Radiation is a common component of treatment for head and neck cancers. The diagnosis of Eagle syndrome secondary to osteoradionecrosis of the styloid process is an elusive, but important, diagnosis to consider because the condition can be treated successfully.

The development and validation of the Bronchiectasis Health Questionnaire.

Health-related quality of life or health status is significantly impaired in bronchiectasis. There is a paucity of brief, simple-to-use, disease-specific health status measures. The aim of this study was to develop and validate the Bronchiectasis Health Questionnaire (BHQ), a new health status measure that is brief and generates a single overall score.Patients with bronchiectasis were recruited from two outpatient clinics, during a clinically stable stage. The development of the questionnaire followed three phases: item generation and item reduction using Rasch analysis, validation, and repeatability testing. The BHQ was translated into 11 languages using standardised methodology.206 patients with bronchiectasis completed a preliminary 65-item questionnaire. 55 items were removed due to redundancy or poor fit to the Rasch model. The final version of the BHQ consisted of 10 items. Internal consistency was good (Cronbach's α=0.85). Convergent validity of the BHQ with the St George's Respiratory Questionnaire was high (r= -0.82; p<0.001) and moderate with lung function (forced expiratory volume in 1 s % predicted r= -0.27; p=0.001). There was a significant association between BHQ scores and number of exacerbations of bronchiectasis in the last 12 months (p<0.001), hospital admissions (p=0.001) and computed tomography scan bronchiectasis pulmonary lobe counts (p<0.001). BHQ scores were significantly worse in patients with sputum bacterial colonisation versus no colonisation (p=0.048). The BHQ was highly repeatable after 2 weeks (intraclass correlation coefficient 0.89).The BHQ is a brief, valid and repeatable, self-completed health status questionnaire for bronchiectasis that generates a single total score. It can be used in the clinic to assess bronchiectasis from the patient's perspective.

Translation and validation of the King's Brief Interstitial Lung Disease (K-BILD) questionnaire in French, Italian, Swedish, and Dutch.

No disease-specific instruments exist in Dutch, French, Italian, and Swedish to measure health status in idiopathic pulmonary fibrosis (IPF) and other interstitial lung diseases (ILDs). The King's Brief Interstitial Lung Disease (K-BILD) is a 15-item validated questionnaire assessing health status in patients with ILD. The aim of this study was to translate and validate the K-BILD to French, Italian, Swedish, and Dutch versions. The K-BILD was translated following a forward-backward multistep procedure and tested in structured patient interviews. Subsequently, 195 outpatients with ILD were asked to complete K-BILD, St. George's Respiratory Questionnaire (SGRQ), and Euroqol EQ-5D-5L (EQ5D), twice, 2 weeks apart. Internal consistency, concurrent validity, and repeatability were determined. No major difficulties occurred in the translation processes. The K-BILD was considered comprehensible and relevant by patients. One hundred seventy-six patients (108 IPF and 68 other ILDs) completed the translated K-BILD. Internal consistency was good for all K-BILD modules (Cronbach's α 0.70-0.93). Concurrent validity of K-BILD was strong compared with SGRQ ( r = -0.86) and EQ5D ( r = 0.68), low with transfer capacity of the lung for carbon monoxide corrected for hemoglobin ( r = 0.33) and with forced vital capacity ( r = 0.35). The K-BILD and its domains were repeatable over 2 weeks; intraclass correlation coefficients were 0.86-0.93 ( n = 159). Known groups validity showed K-BILD was able to discriminate between patients based on severity of disease. K-BILD's validity and reliability for patients with IPF was similar to that of other ILDs. The French, Italian, Swedish, and Dutch translated K-BILD questionnaires were well-received by patients and demonstrated excellent validity comparable to the original English K-BILD.

Paranasal sinus opacification-to-pneumatization ratio applied as a rapid and validated clinician assessment.

BACKGROUND: The utility of clinician-applied instruments, particularly the Lund-Mackay score, in the assessment of paranasal sinus computed tomography (CT) in chronic rhinosinusitis (CRS) remains incompletely defined. The purpose of this study was to determine if a new approach to the evaluation of sinus CT could accurately predict the extent of opacification while remaining simple for clinician use. METHODS: Twenty-four sinus CT scans were measured for the percent of sinus opacification using three-dimensional (3D) volumetric analyses. The same scans were also evaluated using the Lund-Mackay score to measure opacification and the Assessment of Pneumatization of the Paranasal Sinuses (APPS) score to measure total sinus volume (TSV). Correlation analysis was performed for the Lund-Mackay to APPS score ratio as a predictor of percent opacification. Validation analysis was also performed to determine the optimal orientation for Lund-Mackay scoring, which has not previously been described. RESULTS: The Lund-Mackay to APPS score ratio was very strongly correlated with the percentage of sinus opacification measured by 3D volumetric analysis (r = 0.862, r2 = 0.743, p < 0.001). Lund-Mackay scoring was not statistically different between axial-only, coronal-only, or triplanar groups for interrater (p = 0.379) and intrarater reliability (p = 0.312). CONCLUSION: The Lund-Mackay score is validated for rater reliability in multiple orientations. Using the APPS score as a measure of TSV, the Lund-Mackay-to-APPS ratio very strongly correlates with the percentage of sinus opacification by 3D volumetric analysis. Further study will be required to determine if this ratio is predictive of symptom severity.

Factors Influencing the Use of Second-Generation Antipsychotics in Children with Psychosis.

BACKGROUND: In 2011, the U.S. Department of Health and Human Services sent a letter to state Medicaid directors explaining the need for oversight of psychiatric prescriptions for children with mental health disorders. The National Committee for Quality Alliance proposed 3 quality measures for rating managed care organizations (MCOs) that involve use of second-generation or atypical antipsychotics in children. In order to ensure appropriate use and to effectively manage the use of second-generation antipsychotics in children, MCOs need to better understand the factors that influence medication treatment decisions for children. OBJECTIVES: To (a) determine how patient-level and physician-level factors influence decisions to prescribe second-generation antipsychotics to children (aged under 18 years) diagnosed with psychosis and (b) evaluate how the influence of these factors may differ between primary care providers and psychiatrists. METHODS: This study employed a cross-sectional survey of 193 primary care providers and psychiatrists. A web-based patient simulation survey using a fractional factorial design was administered via a commercial vendor. Respondents were presented with simulated patient profiles described by various levels of factors considered to be essential to decision making. Respondents were asked to make treatment recommendations for each profile evaluated. In addition to treatment recommendations, demographics and beliefs about products were measured. Modified Poisson regression accounting for multilevel data was used to identify the factors that significantly affect treatment recommendations. RESULTS: Psychiatrists were more likely to recommend second-generation antipsychotics than primary care practitioners (unadjusted RR = 1.36, 95% CI = 1.23-1.51). Social factors such as foster status or parental concern were not found to be significant predictors of prescribing second-generation antipsychotics. The percentage of a provider's patients using second-generation antipsychotics (RR = 1.002, 95% CI = 1.0002-1.003), patient age (aged 4 years: RR = 0.75, 95% CI = 0.68-0.84; aged 10 years: RR = 0.94, 95% CI = 0.91-0.99; reference group: aged 15 years), and patient disease severity (severe: RR = 1.11, 95% CI = 1.04-1.18; moderate: RR = 1.10, 95% CI = 1.05-1.17; reference group: mild) significantly predicted prescription behavior among primary care providers and psychiatrists. Primary care providers were about twice as likely to recommend antipsychotics if they believed the use of antipsychotics was a labeled indication (RR = 2.16, 95% CI = 1.56-2.98) or a medically accepted use (RR = 1.88, 95% CI = 1.33-2.67), when compared with physicians who believed there was no evidence available. This effect was not significant among psychiatrists. Primary care providers, but not psychiatrists, were also significantly influenced by patient white blood cell (WBC) count. Patients with healthy WBC counts were 1.11 times as likely (95% CI = 1.05-1.17) to receive antipsychotics from primary care providers compared with those with low WBC count. Patient body mass index (BMI) was not found to significantly influence prescribing behavior. Nearly 50% of patients did not receive recommendations for psychosocial care. Primary care providers recommended antipsychotic polypharmacy in 23% of the patient profiles, while psychiatrists did so in 42% of the profiles. CONCLUSIONS: This study provides valuable insight into physician-prescribing practices for antipsychotics. The lack of significance of foster status and parental concern, after controlling for other factors, shows that physicians base their decisions on clinical factors more than social factors. Results for patient BMI and frequency of recommendations of polypharmacy are concerning. The general lack of awareness of evidence supporting use of antipsychotics is also highly concerning. The effects of patient BMI, beliefs about evidence supporting use, and prescribing practices with regard to psychosocial care and antipsychotic polypharmacy provide actionable results for managed care programs looking to improve their quality metrics. The results of this study further demonstrate the need for the immediate implementation of the various proposed quality metrics in this area and for new practice guidelines to raise the current standard of care. DISCLOSURES: No outside funding supported this research. Bentley reports the receipt of grants from PQA and the NACDS Foundation. Patel is employed by Medical Marketing Economics. The authors report no other conflicting interests, potential or otherwise. Study concept and design were contributed by Ramachandran, Banahan, West-Strum, and Bentley. Ramachandran, Banahan, and Patel collected data; data interpretation was performed primarily by Ramachandran, Banahan, and Patel, along with Bentley and West-Strum. The manuscript was primarily written by Ramachandran, along with Banahan and Bentley, and revised by Banahan, Bentley, West-Strum, and Patel.

Validation of the King's Sarcoidosis Questionnaire (KSQ) in a Dutch sarcoidosis population.

BACKGROUND: The King's Sarcoidosis Questionnaire (KSQ) is a brief questionnaire assessing health status using five modules (General Health Status, Lung, Eyes, Skin, Medication) in patients with sarcoidosis. The KSQ was only validated in one English sarcoidosis cohort. OBJECTIVE: The aim of this study was to validate the KSQ in a Dutch sarcoidosis population. METHODS: The KSQ was translated according to international guidelines and tested in interviews with patients. Consecutive outpatients completed multiple questionnaires twice, two weeks apart. Construct validity, internal consistency and repeatability were determined. RESULTS: Of the 98 patients included 85 had lung, 22 skin and 24 eye disease. There was good construct validity of the KSQ General Health Status module against the World Health Organization Quality of Life-BREF questionnaire. The Medication module correlated weak to moderate with most questionnaires. The correlations with organ-specific questionnaires varied from strong for Eyes (r=0.75), Skin (r=-0.62) to moderate for Lung (r=-0.45 with MRC breathlessness scale). Internal consistency was good for all KSQ modules (Cronbach's α 0.72-0.93). Intraclass correlation coefficients (0.70-0.90) and Bland-Altman plots showed good repeatability of the KSQ. CONCLUSION: The Dutch KSQ is the first translation of the English KSQ, validated in a Dutch sarcoidosis population.

Intranasal cross-sectional area and quality of life changes following endoscopic transsphenoidal skull base surgery.

BACKGROUND: Endoscopic transsphenoidal surgical approaches to the skull base may produce alteration of intranasal architecture. Acoustic rhinometry (AR) can provide quantitative data on the nasal airway, which has not been previously applied to skull base surgery. We sought to employ AR to quantify the changes in nasal patency following endoscopic transsphenoidal surgery and identify the relationship between these changes and septal deviation, nasoseptal flap harvest, and sinonasal quality of life (QOL). METHODS: Consecutive patients undergoing endoscopic transsphenoidal resection of a sellar or suprasellar tumor were prospectively enrolled. All subjects were adults who completed AR and the 22-item Sino-Nasal Outcome Test (SNOT-22) preoperatively and postoperatively. Cross-sectional area (CSA) was recorded at the internal nasal valve (CSA1), middle turbinate head (CSA2), and middle turbinate body (CSA3). Normative data were also collected from a larger cohort. RESULTS: Forty patients met study criteria. Significant increases occurred postoperatively in mean CSA2 (1.08 cm(2)) and CSA3 (2.47 cm(2)) (p < 0.001), whereas CSA1 remained unchanged. Nasoseptal flap harvest and correction of septal deviation did not significantly alter mean postoperative AR values. Mean SNOT-22 scores were comparable despite septal pathology, whereas strong correlation was not found with change in AR values. Preoperative and postoperative QOL scores were not significantly affected by the presence of nasal septal deviation. CONCLUSION: The endoscopic transsphenoidal approach to the skull base can result in increased intranasal area without a detrimental effect on sinonasal QOL. These effects are independent of nasoseptal flap harvest and correction of nasal septal deviation.

Palliative care for patients with advanced fibrotic lung disease: a randomised controlled phase II and feasibility trial of a community case conference intervention.

BACKGROUND: Those affected by advanced fibrotic interstitial lung diseases (ILDs) have considerable unmet symptom and psychological needs. Case conferencing has been proposed to address these issues, but requires evaluation. AIM: To obtain preliminary information on the impact of a case conference intervention delivered in the home (Hospital2Home) on palliative care concerns of patients and their carers, and to evaluate feasibility and acceptability. METHODS: Hospital2Home was trialled at a specialist centre using a Phase II fast-track randomised controlled trial with qualitative interviews. The primary outcome for effect was mean change from baseline of Palliative Care Outcome Scale (POS) (a measure of symptoms and concerns) at 4 weeks. Secondary outcomes included symptom control, quality of life, consent and recruitment rates and percentage of patients in the fast-track group receiving case conferences within 14 days. RESULTS: 53 patients were recruited (26 fast-track, 27 controls). Mean (SD) POS scores at 4 weeks were -5.7 (7.5) fast-track vs -0.4 (8.0) control, (mean change difference between the two arms was -5.3 (95% CI -9.8 to -0.7) independent t test p=0.02); effect size (95% CI) -0.7 (-1.2 to -0.1). The secondary outcomes of quality of life, anxiety and depression were superior in the fast-track arm, and none were worse. Qualitative findings corroborate these data. Recruitment was successful and 53/67 (79%) of eligible patients consented. 6/25 (24%) had case conferences within 14 days. CONCLUSIONS: Community case conferences improve palliative symptoms and quality of life after 4 weeks. Hospital2Home for the most part is both feasible and acceptable. It now requires further testing in multicentre trials. TRIAL REGISTRATION NUMBER: NCT01450644.

Rasch analysis and impact factor methods both yield valid and comparable measures of health status in interstitial lung disease.

OBJECTIVES: Rasch analysis has largely replaced impact factor methodology for developing health status measures. The aim of this study was to develop a health status questionnaire for patients with interstitial lung disease (ILD) using impact factor methodology and to compare its validity with that of another version developed using Rasch analysis. STUDY DESIGN AND SETTING: A preliminary 71-item questionnaire was developed and evaluated in 173 patients with ILD. Items were reduced by the impact factor method (King's Brief ILD questionnaire, KBILD-I) and Rasch analysis (KBILD-R). Both questionnaires were validated by assessing their relationship with forced vital capacity (FVC) and St Georges Respiratory Questionnaire (SGRQ) and by evaluating internal reliability, repeatability, and longitudinal responsiveness. RESULTS: The KBILD-R and KBILD-I comprised 15 items each. The content of eight items differed between the KBILD-R and KBILD-I. Internal and test-retest reliability was good for total scores of both questionnaires. There was a good relationship with SGRQ and moderate relationship with FVC for both questionnaires. Effect sizes were comparable. Both questionnaires discriminated patients with differing disease severity. CONCLUSION: Despite considerable differences in the content of retained items, both KBILD-R and KBILD-I questionnaires demonstrated acceptable measurement properties and performed comparably in a clinical setting.

Brachial plexus compression: a rare sequelae of malignant papillary thyroid carcinoma.

Invasive papillary thyroid carcinoma (PTC) can rarely invade adjacent vital structures. There has been one report on secondary brachial plexopathy associated with locally invasive PTC. Here we report a patient with a large locally invasive PTC associated with secondary neoplastic brachial plexopathy. The case exhibits an extremely rare occurrence that has substantial impact on surgical planning and management.

The minimal important difference of the King's Brief Interstitial Lung Disease Questionnaire (K-BILD) and forced vital capacity in interstitial lung disease.

Health status and forced vital capacity (FVC) are widely used outcome measures of interstitial lung disease (ILD) but there is a paucity of studies reporting the minimal clinically meaningful change in these parameters. A study was undertaken to assess the minimal important difference (MID) of an ILD specific health status questionnaire, the King's Brief ILD questionnaire (K-BILD) and that of FVC in a range of ILDs. 57 patients with ILD (17 idiopathic pulmonary fibrosis; IPF) completed the K-BILD (score range 0-100) at 2 separate clinic visits. Patients underwent spirometry at both visits. The MID was determined by a range of distribution methods (Standard error of mean: SEM and 0.3× Effect size: ES) and anchor based methods (objective: FVC and subjective: global rating of change questionnaires, GRCQ). The MID was derived by calculating an average of all methods. Health status was reduced at baseline in all patients, mean (SD) K-BILD total score 62(23). The average MID for K-BILD total score incorporating all methods was an 8 unit change (range 6-10). The average MID for FVC was a 6% change of baseline (range 4-7%). The K-BILD is a responsive patient reported outcome measure for patients with ILD. It can potentially be used to assess patients in the clinic and evaluate the response to therapy. The MID of the K-BILD total score is 8 units. The MID for FVC for a range of ILDs was 6%, similar to that reported recently for patients with IPF. Our findings will facilitate the clinical interpretation of health status and FVC data in ILD.

The development and validation of the King's Brief Interstitial Lung Disease (K-BILD) health status questionnaire.

RATIONALE: Health status is impaired in patients with interstitial lung disease (ILD). There is a paucity of tools that assess health status in ILD. The objective of this study was to develop and validate the King's Brief Interstitial Lung Disease questionnaire (K-BILD), a new health status measure for patients with ILD. METHODS: Patients with ILD were recruited from outpatient clinics. The development of the questionnaire consisted of three phases: item generation; item reduction, allocation to domains by factor analysis, Rasch analysis to create unidimensional scales and validation; and repeatability testing. RESULTS: 173 patients with ILD (49 with idiopathic pulmonary fibrosis) completed a preliminary 71-item questionnaire. 56 items were removed due to redundancy, low factor loadings or poor fit to the Rasch model. The final version of the K-BILD questionnaire consisted of 15 items and three domains (breathlessness and activities, chest symptoms and psychological). Internal consistency assessed with Cronbach's α coefficient was 0.94 for the K-BILD total score. Concurrent validity of the K-BILD questionnaire was high compared with St George's Respiratory Questionnaire (r=0.90) and moderate with lung function (vital capacity, r=0.50). The K-BILD questionnaire was repeatable over 2 weeks (n=44), with intraclass correlation coefficients for domains and total score 0.86-0.94. The K-BILD construct validity for patients with idiopathic pulmonary fibrosis was similar to that of other ILDs. CONCLUSION: The K-BILD questionnaire is a brief, valid, self-completed health status measure for ILD. It could be used in the clinic to assess ILD from the patients' perspective.