Incidence of acute kidney injury (AKI) and its impact on patient outcomes among adult hospitalized patients with carbapenem-resistant Gram-negative infections who received targeted treatment with a newer ß-lactam or ß-lactam/ß-lactamase inhibitor-, polymyxin- or aminoglycoside-containing regimen.

BACKGROUND: Limited comparative data exist on acute kidney injury (AKI) risk and AKI-associated outcomes in hospitalized patients with carbapenem-resistant Gram-negative infections (CR-GNIs) treated with a newer ß-lactam/ß-lactam-ß-lactamase inhibitor (BL/BL-BLI)-, polymyxin (PB)- or aminoglycoside (AG)-containing regimen. This study quantified the risk of AKI and AKI-related outcomes among patients with CR-GNIs treated with a newer BL/BL-BLI-, PB- or AG-containing regimen. METHODS: A multicentre, retrospective, observational study was performed (2016-20). The study included adult hospitalized patients with (i) baseline estimated glomerular filtration rates ≥30 mL/min/1.73 m2; (ii) CR-GN pneumonia, complicated urinary tract infection or bloodstream infection; and (iii) receipt of newer BL/BL-BLI, PG or AG within 7 days of index CR-GN culture for ≥3 days. Outcomes included AKI, in-hospital mortality and hospital costs. RESULTS: The study included 750 patients and most (48%) received a newer BL/BL-BLI. The median (IQR) treatment duration was 8 (5-11), 5 (4-8) and 7 (4-8) days in the newer BL/BL-BLI group, AG group and PB group, respectively. The PB group had the highest adjusted AKI incidence (95% CI) (PB: 25.1% (15.6%-34.6%) versus AG: 8.9% (5.7%-12.2%) versus newer BL/BL-BLI: 11.9% (8.1%-15.7%); P = 0.001). Patients with AKI had significantly higher in-hospital mortality (AKI: 18.5% versus 'No AKI': 5.6%; P = 0.001) and mean hospital costs (AKI: $49 192 versus 'No AKI': $38,763; P = 0.043). CONCLUSIONS: The AKI incidence was highest among PB patients and patients with AKI had worse outcomes. Healthcare systems should consider minimizing the use of antibiotics that augment AKI risk as a measure to improve outcomes in patients with CR-GNIs.

The use of proxies and proxy-reported measures: a report of the international society for quality of life research (ISOQOL) proxy task force.

AIMS: Proxy reports are often used when patients are unable to self-report. It is unclear how proxy measures are currently in use in adult health care and research settings. We aimed to describe how proxy reports are used in these settings, including the use of measures developed specifically for proxy reporting in adult health populations. METHODS: We systematically searched Medline, PsycINFO, PsycTESTS, CINAHL and EMBASE from database inception to February 2018. Search terms included a combination of terms for quality of life and health outcomes, proxy-reporters, and health condition terms. The data extracted included clinical context, the name of the proxy measure(s) used and other descriptive data. We determined whether the measures were developed specifically for proxy use or were existing measures adapted for proxy use. RESULTS: The database search identified 17,677 possible articles, from which 14,098 abstracts were reviewed. Of these, 11,763 were excluded and 2335 articles were reviewed in full, with 880 included for data extraction. The most common clinical settings were dementia (30%), geriatrics (15%) and cancer (13%). A majority of articles (51%) were paired studies with proxy and patient responses for the same person on the same measure. Most paired studies (77%) were concordance studies comparing patient and proxy responses on these measures. DISCUSSION: Most published research using proxies has focused on proxy-patient concordance. Relatively few measures used in research with proxies were specifically developed for proxy use. Future work is needed to examine the performance of measures specifically developed for proxies. SYSTEMATIC REVIEW REGISTRATION: PROSPERO No. CRD42018103179.

Estimation of minimally important differences and responder definitions for EORTC QLQ-MY20 scores in multiple myeloma patients.

OBJECTIVES: Thresholds for the minimally important difference (MID) or responder definition (RD) in health-related quality-of-life (HRQoL) scores are required to interpret the impact of an intervention or change in the trajectory of the condition which is meaningful to patients. This study aimed to establish MID and RD for the European Organisation for Research and Treatment of Cancer Quality of Life Multiple Myeloma questionnaire (EORTC QLQ-MY20). METHODS: A novel mixed-methods approach was applied by utilizing both existing clinical trial data and prospective patient interviews. Anchor-based, distribution-based, and qualitative-based estimates of meaningful change were triangulated to form recommended RDs for each scale of the EORTC QLQ-MY20. Anchor-based MIDs were summarized using weighted correlation. RESULTS: Recommended MIDs were as follows: Disease Symptoms (DS 10 points), Side Effects of Treatment (SE 10 points), Body Image (BI 13 points), and Future Perspective (FP 9 points). Recommended RDs were as follows: DS (16 improvement; 11 worsening), SE (6 improvement; 9 worsening), BI (33 improvement; 33 worsening), and FP (11 improvement; 11 worsening). CONCLUSIONS: The study generated estimates of the MID and RD for each scale of the EORTC QLQ-MY20. Published estimates will enable investigators and clinicians to adopt these as standard for interpretation and for hypothesis testing. Consequently, analyses from trials of different interventions can be more comparable.

The symptom burden of treatment-naive patients with head and neck cancer.

BACKGROUND: The treatment of head and neck cancer (HNC) may cause substantial local and systemic symptomatic morbidities, but many patients have high symptom levels before treatment begins. Knowledge of disease-related (treatment-naive) symptom status would aid in the evaluation of the symptomatic benefit or burden of HNC therapies. METHODS: The authors retrospectively examined symptoms, quality of life, and health status reported by patients with HNC who were naive to any treatment. Symptoms were explored by anatomical site and disease factors were correlated with symptom severity and interference. A clustering algorithm was used to identify a subset of highly symptomatic patients, and the effects of disease site, tumor stage, and demographic variables on membership in this high-symptom group were examined. RESULTS: A total of 748 treatment-naive patients with mucosal (434 patients), nonmucosal (272 patients), or skull base (42 patients) tumors were identified who had rated their symptoms using the MD Anderson Symptom Inventory. The majority of patients were white non-Hispanic (82%) and male (68%), with a median age of 59 years. Approximately one-third the patients had a high pretreatment symptom burden. Pain, fatigue, distress, and disturbed sleep were the most severe symptoms reported, regardless of tumor stage or site. Symptom burden was found to be higher among patients with more advanced disease. Predictors of a high symptom burden included having a mucosal tumor and being female. CONCLUSIONS: The high prevalence of moderate to severe symptoms found in the current study demonstrates the importance of assessing patient-reported symptoms routinely before treatment is initiated and emphasizes the need for symptom management in parallel with disease treatment. Baseline characterization of symptom status should be incorporated into clinical trials that may affect symptom burden.

Real-world evaluation of imipenem/cilastatin/relebactam across US medical centres.

We assessed 160 patients who received imipenem/cilastatin/relebactam for ≥2 days. At treatment initiation, the median Charlson Comorbidity Index was 5, 45% were in the intensive care unit, and 19% required vasopressor support. The in-hospital mortality rate was 24%. These data advance our understanding of real-world indications and outcomes of imipenem/cilastatin/relebactam use.

Characterizing Antibiotic Regimen Modification Behavior, Patient Characteristics, and Outcomes for Patients with Gram-Negative Bacterial Infections, A Retrospective Single-Center Study.

Few studies describe the frequency of antibiotic regimen modification behaviors in the acute care setting. We sought to ascertain patient and treatment characteristics, details of regimen modification, and clinical outcomes with antibiotic modifications. This retrospective study included patients admitted to Hoag Memorial Hospital from 1 January 2019-31 March 2021 with a complicated infection caused by a Gram-negative organism resistant to extended-spectrum cephalosporins or with the potential for resistance (AmpC producers). A total of 400 patients were included. The predominant sources were bloodstream (33%), urine (26%), and respiratory (24%), including patients with multiple sources. The most isolated organisms were Pseudomonas spp. and ESBL-producing organisms, 38% and 34%, respectively. A total of 72% of patients had antibiotic regimen modifications to their inpatient antibiotic regimens. In patients where modifications occurred, the number ranged from one to six modifications. The most common reasons for modifications included a lack of patient response (14%), additional history reviewed (9%), and decompensation (7%). No difference in clinical outcomes was observed based on antibiotic modifications. The numerous changes in therapy observed may reflect the limitations in identifying patients with resistant organisms early on in admission. This highlights the need for more novel antibiotics and the importance of identifying patients at risk for resistant organisms.

Health-Related and Economic Burden Among Family Caregivers of Patients with Acute Myeloid Leukemia or Hematological Malignancies.

INTRODUCTION: Acute myeloid leukemia (AML) is associated with lower survival and greater unmet need compared with some other hematologic malignancies (HMs). Despite differences in acuteness between AML and other HMs, the burden of family caregivers (FCs) of patients with these malignancies offer similar patient experiences. A targeted literature review was conducted to explore FC burden of patients with AML and HM with and without hematopoietic stem cell transplant (HSCT). Instruments to measure and interventions to address FC burden were identified. METHODS: Studies on economic burden and compromised health-related quality of life (HRQoL) associated with FC burden, family affairs, and childcare from 1 January 2010 to 30  June 2019 were identified through database and hand searches. Published English articles on randomized controlled trials or standardized qualitative or quantitative observational studies were included. FCs were those in close familial proximity to the patient (i.e., spouse, parents, children, relatives, other family members, significant others). RESULTS: Seventy-one publications were identified (AML, n = 3; HM, n = 29; HSCT, n = 39). Predominant burden categories included humanistic (n = 33), economic (n = 17), and interventions (n = 22); one study was classified as humanistic and economic. FCs lack sufficient resources to manage stressors and experience negative psychological, behavioral, and physiological effects. FCs of patients with HMs reported post-traumatic stress disorder, significant sleep problems, moderate-to-poor HRQoL, and negative impacts on family relationships. Instruments designed to measure caregiver burden were generic and symptom-specific. Educational, expressional, and self-adjustment interventions were used to improve FC burden. CONCLUSION: Findings indicate a need for additional research, public health approaches to support FCs, and effective interventions to address FC burden. Minimizing FC burden and improving quality of life may reduce the overall healthcare service use and allow FCs to more effectively fulfill caregiver tasks. Support systems to alleviate caregiver burden may create reinforced integrators, thus positively affecting quality of life and possibly the outcomes of patients.

Development and content validation of the Satisfaction and Experience Questionnaire for Granulocyte Colony-Stimulating Factor (SEQ-G-CSF).

BACKGROUND: Several options for granulocyte colony-stimulating factor (G-CSF) prophylaxis of chemotherapy-induced febrile neutropenia are available to patients worldwide. We have developed a novel patient-reported outcome measure, the Satisfaction and Experience Questionnaire for G-CSF (SEQ-G-CSF), to help understand patients' perspectives of and satisfaction with different G-CSF options. RESULTS: Three oncology nurses and 40 adult oncology patients in the United States were enrolled and participated in focus group discussions to develop and refine the SEQ-G-CSF. Nurses had ≥ 5 years of experience treating oncology patients and were currently involved in the management of oncology patients receiving G-CSF prophylaxis. The patients had breast cancer, lung cancer, non-Hodgkin lymphoma, or prostate cancer (10 patients in each group) and were receiving G-CSF prophylaxis via injection or the on-body injector (OBI) device. The preliminary SEQ-G-CSF contained an item relevance questionnaire and three SEQ modules (sociodemographic, medical history, and G-CSF-related healthcare characteristics questionnaires). Twenty-one patients (53% of total sample size) discussed their experience and satisfaction with G-CSF. Their most common experiences were G-CSF effectiveness, convenience and benefits of the OBI, and relationships with healthcare providers. Side effects and having to undergo additional treatment were also reported. Satisfaction with aspects of G-CSF included the OBI and effectiveness of G-CSF treatment; dissatisfaction included inconvenience (having to return to the clinic the next day and administration of the injection) and the insurance approval process. The SEQ-G-CSF was finalized after three rounds of cognitive interviews and includes five domains related to general satisfaction (one item), treatment burden (four items), travel burden (two items), time burden (four items), and treatment compliance (two items). CONCLUSIONS: The SEQ-G-CSF is a novel instrument that quantifies a patient's experience and satisfaction with different G-CSF options using 13 easy-to-understand items. This study provides evidence for the content validity of SEQ-G-CSF. Although further psychometric testing is required, the SEQ-G-CSF may be a useful addition to clinical trials, observational studies, and clinical practice.

Economic burden of disease progression among multiple myeloma patients who have received transplant and at least one line of therapy in the US.

Effects of disease progression on healthcare resource utilization (HRU) and costs among multiple myeloma (MM) patients with ≥1 line of therapy (LOT) who received their first stem cell transplant (SCT) within 1 year of initial MM diagnosis were estimated using a large US claims database. Disease progression was defined as advancement to the next LOT, bone metastasis, hypercalcemia, soft tissue plasmacytoma, skeletal related events, acute kidney disease, or death within 12 months of LOT initiation. Annual HRU and costs in the first three LOTs (L1-L3) were compared for patients with versus without disease progression using inverse probability of treatment weighting to adjust for differences between groups in baseline characteristics. In all LOTs, mean annual hospitalizations and healthcare costs were greater for patients with versus without progression. Total incremental annual costs among patients with versus without progression in L1-L3 were $18,359, $87,055, and $71,917, respectively, among LOTs initiated between 2006 and 2018. In LOTs initiated between 2013 and 2018, the figures were $46,024, $100,329, and $101,942 in L1-L3, respectively. The economic burden of disease progression is substantial in this population of MM patients who underwent SCT and received systemic anti-myeloma therapy.

Burden of disease progression in patients with multiple myeloma in the US.

Effects of disease progression on healthcare resource utilization (HRU) and costs among multiple myeloma (MM) patients with ≥1 line of therapy (LOT) and without receipt of stem cell transplant were estimated using large US claims database. Disease progression was defined as advancement to the next LOT, bone metastasis, hypercalcemia, soft tissue plasmacytoma, skeletal related events, acute kidney failure, or death within 12 months of LOT initiation. Annual HRU and costs in the first four LOTs were compared for patients with versus without progression using inverse probability of treatment weighting to adjust for differences between groups in baseline characteristics. In all LOTs, mean annual hospitalizations and healthcare costs were greater for patients with versus without progression. Total incremental annual costs among patients with versus without progression in 1LOT to 4LOT were $25,920, $30,632, $47,320, and $19,769, respectively. For MM patients receiving drug therapy, the economic burden of disease progression is substantial.

Retraction notice to "Association between low-testosterone and kidney stones in US men: The national health and nutrition examination survey 2011-2012" [Prev. Med. Rep. 10C (2018) 248-253].

[This retracts the article DOI: 10.1016/j.pmedr.2018.04.002.].

Adaptation and Evaluation of a Symptom-Monitoring Digital Health Intervention for Patients With Relapsed and Refractory Multiple Myeloma: Pilot Mixed-Methods Implementation Study.

BACKGROUND: Relapsed and refractory multiple myeloma (RRMM) is a bone marrow cancer that requires systemic treatment, which often results in severe symptom burden. Recent studies have found that electronic patient-reported outcome (ePRO) interventions implemented in the clinic setting have had positive outcomes for other oncology populations. Evidence of the efficacy of a similar approach is lacking for patients with RRMM. OBJECTIVE: Recent recommendations for digital health interventions call for the publication of descriptions of iterative development processes in order to improve reproducibility and comparability. This study is an implementation pilot aiming to evaluate the acceptability and appropriateness of an ePRO intervention for patients with RRMM and to explore its impact on clinic workflow. METHODS: A total of 11 patients with RRMM were recruited from the John Theurer Cancer Center in Hackensack, New Jersey. Patients used a mobile app to report on 17 symptoms at 4 sessions, each a week apart. Patients could also report symptoms ad hoc. When reports met predefined thresholds, the clinic was alerted and patients received automated guidance. Study end points were assessed using qualitative and quantitative methods. RESULTS: A total of 9 patients (mean age 69.7 years) completed the study. Overall, 83% (30/36) of weekly sessions were completed. Patients found the frequency and time required to complete reporting acceptable. All patients agreed that the app was easy to use and understand. Providers felt the alerts they received required refinement. Patients and providers agreed it would be beneficial for patients to report for longer than 4 weeks. Patients felt that the training they received was adequate but contained too much information for a single session. All patients found the symptoms tracked to be appropriate; providers suggested shortening the list. All patients understood how to use the app for weekly reporting but had confusion about using it ad hoc. Providers felt the ad hoc feature could be removed. Neither patients nor providers viewed the in-app data reports but agreed on their potential value. Patients reported benefitting from symptom reporting through increased awareness of their symptoms. Clinic staff reported that app alerts were too numerous and redundant. They had difficulty responding to alerts within their existing workflow, partially because the data were not integrated into the electronic medical record system. CONCLUSIONS: Overall, the intervention was found to be acceptable and appropriate for patients with RRMM. Points of friction integrating the intervention into the clinic workflow were identified. Clinic staff provided recommendations for addressing these issues. Once such modifications are implemented, ePRO data from patients with RRMM could be used to inform and improve clinical research and care. This study underlines the importance of an iterative approach to implementation that includes all stakeholders in order to ensure successful adoption.

Convenience, satisfaction, health-related quality of life of once-weekly 70 mg/m2 vs. twice-weekly 27 mg/m2 carfilzomib (randomized A.R.R.O.W. study).

We compared patient-reported outcomes (PROs) with once-weekly carfilzomib 70 mg/m2 (Kd70 mg/m2) vs. twice-weekly carfilzomib 27 mg/m2 (Kd27 mg/m2) plus dexamethasone in relapsed or refractory multiple myeloma (RRMM). Patient-reported convenience/satisfaction collected at Cycle 2, Day 1 was compared between groups using logistic regression. European Organization for Research and Treatment of Cancer QOL Questionnaire (QLQ-C30), MM-module (QLQ-MY20), and EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L) questionnaires were administered at baseline, then every other cycle. PROs were compared between groups using mixed models for repeated measures. Times from randomization to first deterioration (TTD) in scores were analyzed using Cox regression. PRO analyses included 469 patients. Once-weekly Kd70 mg/m2 patients reported greater convenience (odds ratio [OR], 4.98; p < 0.001) and satisfaction (OR, 2.41; p = 0.059) vs. twice-weekly Kd27 mg/m2. The mixed models for repeated measures demonstrated no clinically meaningful differences in scores between treatment arms. Clinically meaningful deterioration in QLQ-C30 Global Health Status/QOL rates were 34.2% (once-weekly Kd70 mg/m2) vs. 40.3% (twice-weekly Kd27 mg/m2). TTD was longer for once-weekly Kd70 mg/m2 vs. twice-weekly Kd27 mg/m2 for QLQ-C30 fatigue (HR, 0.79; p = 0.035), QLQ-MY20 disease symptoms (HR, 0.67; p = 0.008), EQ-5D-5L index score (HR, 0.58; p = 0.002), and EQ-5D-5L Visual Analog Scale (HR, 0.75, p = 0.031). Once-weekly Kd70 mg/m2 improved convenience/satisfaction, and reduced HRQOL deterioration vs. twice-weekly Kd27 mg/m2, supporting convenient, once-weekly Kd70 mg/m2 dosing in RRMM.

Association between low-testosterone and kidney stones in US men: The national health and nutrition examination survey 2011-2012.

The purpose of this study was to determine the association between low-testosterone (total testosterone ≤3 ng/mL) and prevalence of kidney stones (KS) in men 20 years and older, and whether this varies by comorbidities, and race/ethnicity, and age. This was a cross-sectional study with data from the National Health and Nutrition Examination Survey (NHANES) 2011-2012 cycle. We found that men with low-testosterone had 41% lower odds of KS as compared to men without low-testosterone after multivariable adjustment (OR: 0.59, 95% CI 0.40-0.86). When stratified by obesity, obese men with low-testosterone had 59% lower odds of KS. When stratified by HDL, men with HDL ≥ 40 mg/dL and with low-testosterone had 40% lower odds of KS. When stratified by diabetes, men without diabetes with low-testosterone had 39% lower odds of KS, but the association was not significant in diabetic men with low-testosterone and other comorbidities. There were significant differences when stratified by race/ethnicity. Finally, when stratified by age, only the subgroup of men ≥40-<60 years old with low-testosterone had 68% lower odds of KS (OR: 0.32, 95% CI: 0.16-0.67). The association between low-testosterone and KS was inversed. Similar associations were identified when stratified by obesity, diabetes, dyslipidemia, race/ethnicity and age.

Adverse drug reactions due to drug-drug interactions with proton pump inhibitors: assessment of systematic reviews with AMSTAR method.

INTRODUCTION: Many systematic reviews resulted in claims on drug-drug interactions (DDIs) with proton pump inhibitors (PPIs). Such a large number begs for consensus on the clinical significance of findings. AREAS COVERED: We critically evaluated the safety of PPI use with respect to DDIs with a meta-review of systematic reviews published between 1978 and 2015. We assessed the evidence by their reliability, repeatability, transparency, and objectivity according to the Assessment of Multiple Systematic Reviews (AMSTAR) criteria. EXPERT OPINION: Clinicians must assess risks for each PPI for certain comorbid conditions. DDIs don't substantiate class effect for PPIs; each PPI could induce unique DDIs. Concomitant use of PPIs with thienopyridines (e.g. clopidogrel) could be justified in patients without strong affinity to cytochrome CYP2C19 and with high risk of bleeding (e.g. patients with prior upper gastrointestinal bleeding, Helicobacter pylori infection, advanced age, steroid treatment, and nonsteroidal anti-inflammatory drug use). DDIs could occur in an AIDS subpopulation treated with highly active antiretroviral therapy (HAART). DDIs exist for cancer patients undergoing targeted therapy. Hypomagnesemia could increase in the setting of advanced age and polypharmacy. Omeprazole poses high risks owing to its pharmacokinetic DDI profile. Future systematic reviews should incorporate these additional risks for better clinical guidance.

Validation of the Turkish version of medication regimen complexity index among elderly patients.

OBJECTIVE: The aim of this study was to validate the Turkish version of the 'Medication Regimen Complexity Index' (MRCI). METHODS: This validation study has been conducted in prescriptions of the first 100 elderly patients who had visited the pharmacy for their prescription refill to evaluate convergent and divergent validity of the Turkish version. The reliability of the Turkish version was assessed with inter-rater and test-retest analysis after its translation and cultural adaptation. RESULTS: The mean age of the 100 patients (53 women) was 74.9 years (SD = 7.58, 65-95). The scale showed high inter-rater reliability and test-retest reliability for the total and subscale scores (p < 0.05). A strong and positive correlation between the number of medications in a prescription and the total Medication Regimen Complexity Index scores (r = 0.930, p < 0.001) was determined. There were no statistically significant differences between age, gender and MRCI scores (p > 0.05). CONCLUSION: These results show that the Turkish version of MRCI is a reliable and valid tool in elderly patients.

Assessment of shoulder impairment after functional neck dissection: long term results.

OBJECTIVE: In this prospective study, we attempted to use objective techniques to measure shoulder disability and evaluate patients who underwent functional neck dissection (FND) procedure. Patients were compared on the basis of preoperative and postoperative range of motion (ROM) measurements, pain and stiffness domains. At the final visit, a Neck Dissection Impairment Index (NDII) questionnaire was applied to all patients. METHOD: Twenty-five patients treated with head and neck cancer who underwent bilateral FND simultaneously with the resection of primary tumor enrolled in this study from April 2001 to July 2004. Flexion, extension, abduction, internal and external rotations of the shoulder have been measured with electronic incliometer preoperatively, and at the 1st, 3rd, 6th, and 18th months postoperatively. A questionnaire modified from neck dissection impairment index was applied to all patients to measure neck and shoulder disability at final visit. Pain and stiffness domains were also assessed preoperatively and at postoperative 18th month. RESULTS: Measurements of abduction at the first and third months were found to be decreased in comparison with preoperative measurements. These differences were statistically significant (p<0.05). The pain and stiffness scores of all patients at the final visit were significantly worse than the preoperative scores (p<0.005). At the final visit NDII of patients who underwent total laryngectomy were significantly worse than of the patients who underwent partial laryngectomy and glossectomy (p=0.002 and 0.043, respectively). All these results did not correlate with age, radiation therapy (RT), operation side, T stage. CONCLUSION: FND is oncologicaly safe procedure and gives rise to less shoulder morbidity. Although, ROM improved after 18 months from surgery, pain and stiffness were found to be worse than preoperative values. The patients with total laryngectomy had lower NDII scores regarding to other patients. Therefore, shoulder disability can be attributed not only to neck dissection but also to primary surgery.

Measuring Therapy-Induced Peripheral Neuropathy: Preliminary Development and Validation of the Treatment-Induced Neuropathy Assessment Scale.

UNLABELLED: Various sensory and motor effects are associated with cancer treatment-induced peripheral neuropathy. The current method for capturing the multifaceted nature of neuropathy includes a combination of objective tests, clinician evaluation, and subjective patient report, an approach that is often not logistically feasible, especially for multisite trials. We report the performance of a brief yet comprehensive, easily administered measure, the Treatment-Induced Neuropathy Assessment Scale (TNAS), for assessing the severity and course of neuropathy across various cancer treatments. Data were derived from 4 longitudinal or cross-sectional patient cohorts (N = 573). Patients with multiple myeloma treated primarily with bortezomib and patients with colorectal cancer receiving oxaliplatin evaluated candidate items. Cognitive debriefing showed that all items were easy to understand, and this preliminary TNAS demonstrated reliability, validity, and sensitivity. Numbness/tingling was the most severe item, regardless of therapeutic agent. Although numbness and general pain were moderately correlated, patients perceived them as distinct. Most TNAS items were more severe at follow-up, demonstrating the sensitivity of the instrument to accumulating dose. The TNAS will be refined with further patient input, with final psychometric evaluation conducted in a new patient sample receiving treatments known to be associated with peripheral neuropathy. The nonpainful component of neuropathy may be more disabling than the pain component. PERSPECTIVE: Our data suggest that the nonpainful components of neuropathy may be more disabling than the pain component during cancer treatment. Here we report data on sensory and motor symptoms reported by patients receiving neurotoxic cancer therapy, and we detail the development of a neuropathy assessment scale that follows regulatory guidance for patient-reported outcomes.

Body position and obstructive sleep apnea syndrome.

In adults, influence of body position on the occurrence of respiratory events during sleep is recognized, and increased numbers of respiratory events occur when the supine position is assumed.1-4 In 1985, Orr et al. showed that body position did not influence respiratory events during sleep in children.5 Recently, Fernandes do Prado et al. showed that children had a lower obstructive apnea hypopnea index (AHI) in supine position.6 Results of these two studies are different from others performed on adults. Moreover, upper airway abnormalities were not considered in these studies. The aim of the present study was to evaluate the effect of body position on obstructive respiratory events in children with different upper airway findings.

Bilateral oroantral fistulas following devitalization of teeth by arsenic trioxide: a case report.

Although it is well known that prolonged application or leakage of arsenic trioxide can cause severe damage to the periodontal tissues, the substance is still used by some dentists. This paper describes a case of arsenical necrosis of the jaws affecting the right and the left side of the maxilla. As a result of leakage into the tissues of an arsenical paste from the pulp chamber of endodontically treated teeth, bilateral oroantral fistula (OAF) occurred. It is concluded that there is no justification, whatsoever, for the use of arsenic in modern dental practice. In the following case, buccal advancement flap and submucosal palatal island flap techniques were used for to close the OAF. The submucosal palatal island flap technique resulted in successful closure of the OAF.