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Importance - Patient-reported outcome (PRO) measures address the need for patient-centered data and are now used in diverse clinical, research, and policy pursuits. They are important in conditions causing upper airway-related dyspnea in which the patient's reported experience and physiological data can be discrepant.
Objectives - To perform a systematic review of the literature on upper airway dyspnea-related PRO measures and to rigorously evaluate each measure's developmental properties, validation, and applicability.
Evidence Review - This study strictly adhered to Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) guidelines. MEDLINE via the PubMed interface, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), and the Health and Psychosocial Instruments (HaPI) database were searched using relevant vocabulary terms and key terms related to PRO measures and upper airway-related dyspnea. Three investigators performed abstract review, and 2 investigators independently performed full-text review by applying an established checklist to evaluate the conceptual model, content validity, reliability, construct validity, scoring and interpretability, and respondent burden and presentation of each identified instrument. The initial literature search was conducted in November 2014 and was updated in April 2016.
Findings - Of 1269 studies reviewed, 3 upper airway-related dyspnea PRO measures met criteria for inclusion. One PRO measure was designed de novo to assess upper airway-related dyspnea symptoms and monitor treatment outcomes, while 2 were adapted from established instruments designed for lower airway disease. Measurement properties and psychometric characteristics differed, and none met all checklist criteria. Two met a criterion in each of 7 domains evaluated. Two demonstrated test-retest and internal consistency reliability, and 2 showed that their scores were responsive to change. Thematic deficiencies in current upper airway-related dyspnea PRO measures are lack of patient involvement in item development (content validity), plan for interpretation, and literacy level assessments.
Conclusions and Relevance - PRO measures are critical in the assessment of patients with upper airway-related dyspnea. Three instruments with disparate developmental rigor have been designed or adapted to assess this construct. Care must be taken to understand the measurement characteristics and contextual relevance before applying these PRO measures for clinical, research, or quality initiatives.
This retrospective analysis aimed to establish the overall cardiac safety profile of bortezomib using patient-level data from one phase 2 and seven phase 3 studies in previously untreated and relapsed/refractory multiple myeloma (MM). Seven clinically relevant primary [congestive heart failure (CHF), arrhythmias, ischaemic heart disease (IHD), cardiac death] and secondary (hypertension, dyspnoea, oedema) cardiac endpoints were defined based on MedDRA v16.0 preferred terms. 2509 bortezomib-treated patients and 1445 patients in non-bortezomib-based control arms were included. The incidence of grade ≥3 CHF was 1·3-4·0% in studies in relapsed/refractory MM and 1·2-4·7% in previously untreated MM (2·0-7·6% all grades), with no significant differences between bortezomib- and non-bortezomib-based arms in comparative studies. Incidences of arrhythmias (1·3-5·9% grade ≥2; 0·6-4·1% grade ≥3), IHD (1·2-2·9% all grades; 0·4-2·7% grade ≥3) and cardiac death (0-1·4%) were low, with no differences between bortezomib-based and non-bortezomib-based arms. Higher rates of oedema (mostly grade 1/2) were seen in bortezomib-based versus non-bortezomib-based arms in one study and a pooled transplant study analysis. Logistic regression analyses of comparative studies showed no impact on cardiac risk with bortezomib-based versus non-bortezomib-based treatment. Bortezomib-based treatment was associated with low incidences of cardiac events.
© 2017 John Wiley & Sons Ltd.
BACKGROUND - Routine manometry is recommended to prevent complications during therapeutic thoracentesis, but has not definitively been shown to prevent pneumothorax or reexpansion pulmonary edema. As chest discomfort correlates with negative pleural pressures, we aimed to determine whether the use of manometry could anticipate the development of chest discomfort during therapeutic thoracentesis.
METHODS - A retrospective chart review of 214 consecutive adults who underwent outpatient therapeutic thoracentesis at our institution between January 1, 2011 and June 30, 2013 was performed. We compared preprocedural to postprocedural discomfort (using a linear analog scale from 0 to 10) in patients undergoing thoracentesis with or without manometry. We used a multivariate model to adjust for possible confounders. Changes of dyspnea scores were also analyzed.
RESULTS - Manometry was performed in 82/214 patients (38%). On univariate and multivariate analyses, neither the change in chest discomfort nor dyspnea scores was significantly different in the manometry versus the control group (P=0.12 and 0.24, respectively). Similar results were also found in the subgroup of large-volume thoracentesis (P=0.32 for discomfort, P=1.0 for dyspnea).
CONCLUSIONS - In our retrospective study, the use of manometry did not appear to anticipate the development of chest discomfort during therapeutic thoracentesis. Prospective studies are needed to confirm these findings.
While a doctor-diagnosis of asthma is associated with an increased risk of pain and acute chest syndrome (ACS) in children with sickle cell anemia (SCA), little is known about the relationship between specific asthma characteristics and clinical factors and future morbidity in children with SCA. We evaluated the relationship between (i) asthma risk factors at the time of a clinical visit (respiratory symptoms, maternal history of asthma, allergy skin tests, spirometry results) and (ii) the known risk factor of ACS early in life, on prospective pain and ACS episodes in a cohort of 159 children with SCA followed from birth to a median of 14.7 years. An ACS episode prior to 4 years of age, (incidence rate ratio [IRR] = 2.84; P < 0.001], female gender (IRR = 1.80; P = 0.009), and wheezing causing shortness of breath (IRR = 1.68; P = 0.042) were associated with future ACS rates. We subsequently added spirometry results (obstruction defined as FEV1 /FVC less than the lower limits of normal; and bronchodilator response, FEV1 ≥ 12%) and prick skin test responses to the model. Only ≥ 2 positive skin tests had a significant effect (IRR 1.87; P = 0.01). Thus, early in life ACS events, wheezing causing shortness of breath, and ≥ 2 positive skin tests predict future ACS events.
© 2014 Wiley Periodicals, Inc.
The physiologic basis for relief from dyspnea after therapeutic thoracentesis remains poorly understood. Here, we describe the case of a 46-year-old man with large recurrent pleural effusion with absent perfusion to the affected lung who experienced dramatic dyspnea relief after large-volume thoracentesis. This patient's improvement in breathlessness cannot be attributed to improved gas exchange and suggests the primary physiologic basis for the relief in dyspnea is a change in respiratory system mechanics or work of breathing.
OBJECTIVES/HYPOTHESIS - Patients with extraesophageal symptoms are often suspected of having gastroesophageal reflux disease (GERD). However, the true prevalence and severity of reflux disease is not well studied. In this group of patients, the objectives of our study were to determine the prevalence and severity of esophageal acid exposure and classify the endoscopic findings.
STUDY DESIGN - Prospective cohort study.
METHODS - One hundred twenty-eight patients with extraesophageal symptoms underwent 48 hours of Bravo pH monitoring. Percent of time that pH was <4 (total upright and supine) was measured. Severity of reflux was categorized by the percent of total time pH was <4, with mild = >4.2% but <10%, moderate = 10% to 20%, and severe>20%. Endoscopic signs of esophagitis and Barrett's esophagus were determined.
RESULTS - There were 104/128 (81%) patients who had abnormal esophageal acid exposure, 44% in the upright and supine position, 38% in the upright position only, and 18% in the supine position only. There were 59/128 (46%) patients with mild reflux, 40/128 (31%) with moderate, and only 5/128 (4%) patients with severe reflux. 23/128 (18%) patients had evidence of esophagitis. Only 1/128 (0.8%) patients had pathologic Barrett's esophagus. Prevalence of abnormal esophageal acid exposure was similar in those with (75%) or without (66%) concomitant heartburn and/or regurgitation (P = .3).
CONCLUSIONS - Abnormal esophageal pH is common in patients with extraesophageal symptoms. Most have only mild (46%) to moderate (31%) reflux with a low prevalence of esophagitis (18%) or Barrett's esophagus (0.8%). The degree of esophageal acid reflux cannot be predicted from baseline presence or absence of typical GERD symptoms.
Copyright © 2011 The American Laryngological, Rhinological, and Otological Society, Inc.
BACKGROUND - Z4032 was a randomized study conducted by the American College of Surgeons Oncology Group comparing sublobar resection alone versus sublobar resection with brachytherapy for high-risk operable patients with non-small cell lung cancer (NSCLC). This evaluates early impact of adjuvant brachytherapy on pulmonary function tests, dyspnea, and perioperative (30-day) respiratory complications in this impaired patient population.
METHODS - Eligible patients with stage I NSCLC tumors 3 cm or smaller were randomly allocated to undergo sublobar resection with (SRB group) or without (SR group) brachytherapy. Outcomes measured included the percentage predicted forced expiratory volume in 1 second (FEV1%), percentage predicted carbon monoxide diffusion capacity (DLCO%), and dyspnea score per the University of California San Diego Shortness of Breath Questionnaire. Pulmonary morbidity was assessed per the Common Terminology Criteria for Adverse Events version 3.0. Outcomes were measured at baseline and 3 months. A 10% change in pulmonary function test or 10-point change in dyspnea score was deemed clinically meaningful.
RESULTS - Z4032 permanently closed to patient accrual in January 2010 at 224 patients. At 3-month follow-up, pulmonary function data are currently available for 148 (74 SR and 74 SRB) patients described in this report. There were no differences in baseline characteristics between arms. In the SR arm, 9 patients (12%) reported grade 3 respiratory adverse events, compared with 12 (16%) in the SRB arm (P = .49). There was no significant change in percentage change in DLCO% or dyspnea score from baseline to 3 months within either arm. In the case of FEV1%, percentage change from baseline to 3 months was significant within the SR arm (P = .03), with patients reporting improvement in FEV1% at month 3. Multivariable regression analysis (adjusted for baseline values) showed no significant impact of treatment arm, tumor location (upper vs other lobe), or surgical approach (video-assisted thoracoscopic surgery vs thoracotomy) on 3-month FEV1%, DLCO%, and dyspnea score. There was no significant difference in incidence of clinically meaningful (10% pulmonary function or 10-point dyspnea score change) change between arms. Twenty-two percent of patients with lower-lobe tumors and 9% with upper-lobe tumors demonstrated 10% decline in FEV1% (odds ratio, 2.79; 95 confidence interval, 1.07-7.25; P = .04).
CONCLUSIONS - Adjuvant intraoperative brachytherapy in conjunction with sublobar resection did not significantly worsen pulmonary function or dyspnea at 3 months in a high-risk population with NSCLC, nor was it associated with increased perioperative pulmonary adverse events. Lower-lobe resection was the only factor significantly associated with clinically meaningful decline in FEV1%.
Copyright © 2011 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.