Health-related quality of life in patients given ciltacabtagene autoleucel for relapsed or refractory multiple myeloma (CARTITUDE-1): a phase 1b-2, open-label study.

Background: CARTITUDE-1 is a phase 1b-2 study evaluating ciltacabtagene autoleucel (cilta-cel), a chimeric antigen receptor T cell therapy with two B-cell maturation antigen-targeting single-domain antibodies, in patients with relapsed or refractory multiple myeloma. Primary efficacy outcomes have previously been reported. Here, we report health-related quality of life (HRQOL) secondary outcomes evaluated using patient-reported outcomes.

Health-related Quality of Life at the SPARTAN Final Analysis of Apalutamide for Nonmetastatic Castration-resistant Prostate Cancer Patients Receiving Androgen Deprivation Therapy.

Background: In SPARTAN, apalutamide improved metastasis-free and overall survival for patients with nonmetastatic castration-resistant prostate cancer (nmCRPC) with a prostate-specific antigen doubling time of ≤10 mo.

Objective: We evaluated health-related quality of life (HRQoL) at the final analysis of the SPARTAN study.

Intervention: Patients received apalutamide (240 mg/d) or placebo in 28-d cycles.

Patient-reported symptom burden of chronic graft versus host disease: a systematic literature review.

Introduction: Chronic graft-versus-host disease (GVHD) is a life-threating complication of allogeneic hematopoietic stem cell transplantation (HSCT) leading to high morbidity and quality of life issues. We conducted a systematic literature review on the patient reported symptom burden of chronic GVHD.

Areas Covered: English-language articles published between 2005 and November 2018 were searched using CENTRAL, EMBASE and MEDLINE.

Content validity of patient-reported outcomes for use in lower-risk myelodysplastic syndromes.

Background: The lower-risk (low and intermediate-1 risk based on IPSS) myelodysplastic syndrome (MDS) has a negative impact on patients' health-related quality of life (HRQoL). Patient Reported Outcomes (PROs) instruments, which are used to collect patients' HRQoL data, should have established content validity in the target population to ensure that the instrument is comprehensive and comprehensible. The present study was conducted to evaluate the content validity of the Quality of Life in Myelodysplasia Scale (QUALMS) and the Functional Assessment of Cancer Therapy-Anemia (FACT-An) PRO instruments in patients with lower-risk MDS.

Response scale selection in adult pain measures: results from a literature review.

Background: The purpose of this literature review was to examine the existing patient-reported outcome measurement literature to understand the empirical evidence supporting response scale selection in pain measurement for the adult population.

Methods: The search strategy involved a comprehensive, structured, literature review with multiple search objectives and search terms.

Results: The searched yielded 6918 abstracts which were reviewed against study criteria for eligibility across the adult pain objective.

Quantifying the importance of inhaler attributes corresponding to items in the patient satisfaction and preference questionnaire in patients using Combivent Respimat.

Background: Physicians consider ease of use, satisfaction, and preferences when prescribing an inhaler device. These factors may impact appropriate usage and compliance.

Methods: The objectives were to quantify the relative importance of inhaler attributes in patients currently using Combivent Respimat by eliciting preferences for performance and convenience attributes assessed by items in the Patient Satisfaction and Preference Questionnaire (PASAPQ).

A randomized study to evaluate the analgesic efficacy of a single dose of the TRPV1 antagonist mavatrep in patients with osteoarthritis.

Background/aims: Transient receptor potential vanilloid type 1 (TRPV1) receptor antagonists have been evaluated in clinical studies for their analgesic effects. Mavatrep, a potent, selective, competitive TRPV1 receptor antagonist has demonstrated pharmacodynamic effects consistent with target engagement at the TRPV1 receptor in a previous single-dose clinical study. The current study was conducted to evaluate the analgesic effects of a single dose of mavatrep.

Initial development of a patient-reported outcome measure of experience with cognitive impairment associated with schizophrenia.

Cognitive impairment is a serious, often distressing aspect of schizophrenia that affects patients' day-to-day lives. Although several interview-based instruments exist to assess cognitive functioning, a reliable measure developed based on the experiences of patients facing cognitive difficulties is needed to complement the objective performance-based assessments. The present article describes the initial development of a patient-reported outcome (PRO) measure to assess the subjective experience of cognitive impairment among patients with schizophrenia, the Patient-Reported Experience of Cognitive Impairment in Schizophrenia (PRECIS).

Measures That Identify Prescription Medication Misuse, Abuse, and Related Events in Clinical Trials: ACTTION Critique and Recommended Considerations.

Unlabelled: Accurate assessment of inappropriate medication use events (ie, misuse, abuse, and related events) occurring in clinical trials is an important component in evaluating a medication's abuse potential. A meeting was convened to review all instruments measuring such events in clinical trials according to previously published standardized terminology and definitions. Only 2 approaches have been reported that are specifically designed to identify and classify misuse, abuse, and related events occurring in clinical trials, rather than to measure an individual's risk of using a medication inappropriately: the Self-Reported Misuse, Abuse, and Diversion (SR-MAD) instrument and the Misuse, Abuse, and Diversion Drug Event Reporting System (MADDERS).

Development and preliminary validation of the focused analgesia selection test to identify accurate pain reporters.

Clinical trials of analgesics have been plagued with poor assay sensitivity due, in part, to variability in subjects' pain reporting. Herein, we develop and evaluate the focused analgesia selection test (FAST), a method to measure patients' pain reporting skills. Subjects with osteoarthritis of the hip, knee, and/or ankle with pain intensity of ≥3/10 on a 0-10 numerical rating scale were enrolled.

Development and feasibility of the misuse, abuse, and diversion drug event reporting system (MADDERS®).

Background And Objectives: Inappropriate use of analgesic drugs has become increasingly pervasive over the past decade. Currently, drug abuse potential is primarily assessed post-marketing; no validated tools are available to assess this potential in phase II and III clinical trials. This paper describes the development and feasibility testing of a Misuse, Abuse, and Diversion Drug Event Reporting System (MADDERS), which aims to identify potentially abuse-related events and classify them according to a recently developed classification scheme, allowing the quantification of these events in clinical trials.

Social Influence on Adolescent Polysubstance Use: The Escalation to Opioid Use.

Background: Fewer than 9% of 12-17 year olds in need (∼146,000 of 1.7 million) receive inpatient or outpatient substance abuse recovery services or other mental health services (SAMHSA, 2012). The literature on adolescent addiction is sparse, however, as most published addiction recovery efforts involve adult populations-often college students.

Validation of the Hospital Anxiety and Depression Scale in Patients With Acute Low Back Pain.

Unlabelled: The Hospital Anxiety and Depression Scale (HADS) is a self-report instrument used to evaluate depression and anxiety in clinical research. The HADS has advantages over other assessments of anxiety and depression; it is efficient in assessing both anxiety and depression with a total of 14 items, and it was originally developed on a general medical rather than psychiatric sample. However, the HADS has not been evaluated specifically for use in clinical trials of acute pain.

Predicting Response to Subacromial Injections and Lidocaine/Tetracaine Patch from Pretreatment Pain Quality in Patients with Shoulder Impingement Syndrome.

Objectives: No existing pain treatment is effective for all pain problems, and response to pain treatment is highly variable. Knowledge regarding the patient factors that predict response to different treatments could benefit patients by providing an empirical foundation for patient-treatment matching. This study sought to test the hypothesis that improvements following two treatments thought to operate via similar mechanisms would be predicted by similar baseline pain qualities.

Root cause analysis of prescription opioid overdoses.

Unlabelled: Overdoses (ODs) of prescription opioids (RxOs) have become a major public health issue in the United States.

Objective: To determine the root causes of accidental prescription opioid overdoses (RxO-OD).

Design/setting/participants/intervention: The authors conducted a root cause analysis using the Antecedent Target-Measurement method, interviewing three types of key informants: survivors of RxO-ODs, family members, and clinical experts.

Validation of the Short-form McGill Pain Questionnaire-2 (SF-MPQ-2) in acute low back pain.

Unlabelled: The Short-form McGill Pain Questionnaire (SF-MPQ-2) assesses the major symptoms of both neuropathic and nonneuropathic pain and can be used in studies of epidemiology, natural history, pathophysiologic mechanisms, and treatment response. Previous research has demonstrated its reliability, validity, and responsiveness in diverse samples of patients with chronic pain. However, the SF-MPQ-2 has not been evaluated for use in patients with acute pain.

Development of a bedside pain assessment kit for the classification of patients with osteoarthritis.

There are no standardized bedside assessments for subtyping patients with osteoarthritis (OA) based on pain mechanisms. Thus, we developed a bedside sensory testing kit (BSTK) to classify OA patients based on sensory profiles potentially indicative of pain mechanism. After usability and informal reliability testing (n = 22), the kit was tested in a formal reliability study (n = 20).

The pain quality response profile of a corticosteroid injections and heated lidocaine/tetracaine patch in the treatment of shoulder impingement syndrome.

Objectives: To describe the effects of 2 pain treatments for shoulder impingement syndrome (SIS), and illustrate how investigators can use pain quality information to understand treatment response differences.

Materials And Methods: This study presents pain quality data from a randomized open-label study comparing the effects of an injection of triamcinolone and up to twice daily application of a heated lidocaine/tetracaine (Trilexis) patch in individuals with SIS. Study participants completed a measure of pain quality at baseline and again on study days 14, 28, and 42 following initiation of 2 treatments for SIS.

A brief survey to characterize oxycodone abuse patterns in adolescents enrolled in two substance abuse recovery high schools.

Background: Although oxycodone is one of the most widely available and abused opioids, little published information exists on the abuse of immediate-release oxycodone.

Objective: To obtain information on abuse of oxycodone and the effectiveness of abuse-deterrent strategies, especially for immediate-release oxycodone, we surveyed oxycodone abuse patterns in a population of experienced opioid abusers.

Methods: Students or recent graduates of two substance abuse recovery high schools in Massachusetts were surveyed on abuse behaviors with short-acting single-entity oxycodone (e.

Determining the clinically important difference in visual analog scale scores in abuse liability studies evaluating novel opioid formulations.

Purpose: This study determined how the magnitude of change in positive subjective responses predicts clinical outcome in a treatment setting. Specifically, we attempted to define what constitutes a clinically important difference (CID) in subjective responses.

Methods: A 100-mm visual analog scale (VAS) measured subjective ratings of drug "high," calculated via an anchor-based method with published data from participants receiving sustained-release naltrexone (NTX) and heroin in a laboratory setting.

Embodiment and abstraction: actions create relational representations.

Theories of embodied, modal representation propose that concepts are grounded in the sensorimotor system. According to these theories, action (or the potential for action) creates meaning. An apparent challenge for these theories is the fact that higher-order relations (i.