Explore the vast range of titles available.

Background Patient-reported physical function (PF) is a key endpoint in cancer clinical trials. Using complex statistical methods, common metrics have been developed to compare scores from different patient-reported outcome (PRO) measures, but such methods do not account for possible differences in questionnaire content. Therefore, the aim of our study was a content comparison of frequently used PRO measures for PF in cancer patients. Methods Relying on the framework of the International Classification of Functioning, Disability and Health (ICF) we categorized the item content of the physical domains of the following measures: EORTC CAT Core, EORTC QLQ-C30, SF-36, PROMIS Cancer Item Bank for Physical Function, PROMIS Short Form for Physical Function 20a, and the FACT-G. Item content was linked to ICF categories by two independent reviewers. Results The 118 items investigated were assigned to 3 components (‘d – Activities and Participation’, ‘b – Body Functions’, and ‘e – Environmental Factors’) and 11 first-level ICF categories. All PF items of the EORTC measures but one were assigned to the first-level ICF categories ‘d4 – Mobility’ and ‘d5 – Self-care’, all within the component ‘d – Activities and Participation’. The SF-36 additionally included item content related to ‘d9 – Community, social and civic life’ and the PROMIS Short Form for Physical Function 20a also included content related to ‘d6 – domestic life’. The PROMIS Cancer Item Bank (v1.1) covered, in addition, two first-level categories within the component ‘b – Body Functions’. The FACT-G Physical Well-being scale was found to be the most diverse scale with item content partly not covered by the ICF framework. Discussion Our results provide information about conceptual differences between common PRO measures for the assessment of PF in cancer patients. Our results complement quantitative information on psychometric characteristics of these measures and provide a better understanding of the possibilities of establishing common metrics.

To evaluate the effectiveness of the Genomics ADvISER (www.genomicsadviser.com) decision aid (DA) for selection of secondary findings (SF), compared with genetic counseling alone. A randomized controlled trial (RCT) was conducted to evaluate whether the Genomics ADvISER is superior to genetic counseling when hypothetically selecting SF. Participants were randomized to use the DA followed by discussion with a genetic counselor, or to genetic counseling alone. Surveys were administered at baseline and post-intervention. Primary outcome was decisional conflict. Secondary outcomes were knowledge, preparation for, and satisfaction with decision-making, anxiety, and length of counseling session. Participants (n = 133) were predominantly White/European (74%), female (90%), and ≥50 years old (60%). Decisional conflict (mean difference 0.05; P = 0.60), preparation for decision-making (0.17; P = 0.95), satisfaction with decision (–2.18; P = 0.06), anxiety (0.72; P = 0.56), and knowledge of sequencing limitations (0.14; P = 0.70) did not significantly differ between groups. However, intervention participants had significantly higher knowledge of SF (0.39; P < 0.001) and sequencing benefits (0.97; P = 0.01), and significantly shorter counseling time (24.40 minutes less; P < 0.001) The Genomics ADvISER did not decrease decisional conflict but reduced counseling time and improved knowledge. This decision aid could serve as an educational tool, reducing in-clinic time and potentially health care costs.

Neuropathological and neuroimaging studies in Huntington disease (HD) have suggested a role for the cerebellum. Our goal was to perform a detailed evaluation of cerebellar morphology. We performed the Unified HD rating scale (UHDRS) and Montreal cognitive assessment (MOCA) in 26 HD patients and 26 healthy controls. We created a two-sample test to analyze cerebellar gray matter (GM) differences between groups and another to correlate GM alterations with UHDRS and MOCA, corrected for age, expanded cytosine-adenine-guanine repeats, and disease duration using the spatially unbiased atlas template (SUIT)-SPM-toolbox which preserves anatomical detailing. We found increased GM density in the anterior cerebellum compared to controls. Higher GM density in the postero-superior lobe correlated with mood symptoms. Worse motor function and better cognitive function correlated with GM changes in the posterior cerebellum (false discovery rate (FDR) correction p  < 0.05 and k  > 100 voxels). In this detailed study of the in vivo cerebellar morphology in HD, we observed GM changes in regions involved in sensorimotor integration, motor planning, and emotional processing, supporting cerebellar involvement in the neuropathological process of HD.

Purpose The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life-Core Questionnaire (QLQ-C30) is a widely used generic self-report measure of health-related quality of life (HRQOL) for cancer patients. However, no validated voice script for interviewer-led telephone administration was previously available. The aim of this study was to develop a voice script for interviewer administration via telephone. Methods Following guidelines from the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) PRO Mixed Modes Good Research Practices Task Force, a randomised cross-over equivalence study, including cognitive debriefing, was conducted to assess equivalence between paper and telephone administration modes. Assuming an expected intraclass correlation coefficient (ICC) of 0.70 and a minimally acceptable level of 0.50, a sample size of 63 was required. Results Cognitive interviews with five cancer patients found the voice script to be clear and understandable. Due to a protocol deviation in the first wave of testing, only 26 patients were available for analyses. A second wave of recruitment was conducted, adding 37 patients ( n  = 63; mean age 55.48; 65.1% female). Total ICCs for mode comparison ranged from 0.72 (nausea and vomiting, 95% CI 0.48–0.86) to 0.90 (global health status/QoL, 95% CI 0.80–0.95; pain, 95% CI 0.79–0.95; constipation, 95% CI 0.80–0.95). For paper first administration, all ICCs were above 0.70, except nausea and vomiting (ICC 0.55; 95% CI 0.24–0.76) and financial difficulties (ICC 0.60; 95% CI 0.31–0.79). For phone first administration, all ICCs were above 0.70. Conclusions The equivalence testing results support the voice script’s validity for administration of the QLQ-C30 via telephone.

Guidelines recommend that providers engage patients in shared decision-making about receiving incidental results (IR) prior to genomic sequencing (GS), but this can be time-consuming, given the myriad of IR and variation in patients’ preferences. We aimed to develop patient profiles to inform pre-test counseling for IR. We conducted semi-structured interviews with participants as a part of a randomized trial of the GenomicsADvISER.com, a decision aid for selecting IR. Interviews explored factors participants considered when deliberating over learning IR. Interviews were analyzed by thematic analysis and constant comparison. Participants were mostly female (28/31) and about half of them were over the age of 50 (16/31). We identified five patient profiles that reflect common contextual factors, attitudes, concerns, and perceived utility of IR. Information Enthusiasts self-identified as “planners” and valued learning most or all IR to enable planning and disease prevention because “knowledge is power”. Concerned Individuals defined themselves as “anxious,” and were reluctant to learn IR, anticipating negative psychological impacts from IR. Contemplators were discerning about the value and limitations of IR, weighing health benefits with the impacts of not being able to “un-know” information. Individuals of Advanced Life Stage did not consider IR relevant for themselves and primarily considered their implications for family members. Reassurance Seekers were reassured by previous negative genetic test results which shaped their expectations for receiving no IR: “hopefully [GS will] be negative, too. And then I can rest easy”. These profiles could inform targeted counseling for IR by providing a framework to address common values, concerns. and misconceptions.

BackgroundObesity causes secondary hypogonadism (HG) in men. Standard testosterone (T) replacement therapy improves metabolic parameters but leads to infertility.ObjectiveTo evaluate clomiphene citrate (CC) treatment of adult men with male obesity-associated secondary hypogonadism (MOSH).DesignSingle-center, randomized, double-blind, placebo-controlled trial.ParticipantsSeventy-eight men aged 36.5 ± 7.8 years with a body mass index (BMI) > 30 kg/m2, total testosterone (TT) ≤ 300 ng/dL, and symptoms in the ADAM questionnaire.InterventionRandom allocation to receive 50 mg CC or placebo (PLB) for 12 weeks.Outcomes(1) Clinical features: ADAM and sexual behavior questionnaires; (2) hormonal profile: serum TT, free T, estradiol (E2), luteinizing hormone (LH), follicle-stimulating hormone (FSH), and sex hormone-binding globulin (SHBG); (3) body composition: BMI, waist circumference, and bioelectric impedance analysis; (4) metabolic profile: blood pressure, fasting blood glucose, HbA1c, insulin, HOMA-IR, and lipid profile; (5) endothelial function: flow-mediated dilation of the brachial artery, quantitative assessment of endothelial progenitor cells and serum sICAM-1, sVCAM-1, and selectin-sE levels; (6) safety aspects: hematocrit, serum prostate-specific antigen, International Prostate Symptom Score, and self-reported adverse effects.ResultsThere was an improvement in one sexual complaint (weaker erections; P < 0.001); increases (P < 0.001) in TT, free T, E2, LH, FSH, and SHBG; and improvements in lean mass (P < 0.001), fat-free mass (P = 0.004), and muscle mass (P < 0.001) in the CC group. CC reduced HDL (P < 0.001). No statistically significant differences were seen in endothelial function.ConclusionsCC appeared to effectively improve the hormonal profile and body composition. CC may be an alternative treatment for MOSH in adult men.

The use of item libraries for patient-reported outcome (PRO) measurement in oncology allows for the customisation of PRO assessment to measure key health-related quality of life concepts of relevance to the target population and intervention. However, no high-level recommendations exist to guide users on the design and implementation of these customised PRO measures (item lists) across different PRO measurement systems. To address this issue, a working group was set up, including international stakeholders (academic, independent, industry, health technology assessment, regulatory, and patient advocacy), with the goal of creating recommendations for the use of item libraries in oncology trials. A scoping review was carried out to identify relevant publications and highlight any gaps. Stakeholders commented on the available guidance for each research question, proposed recommendations on how to address gaps in the literature, and came to an agreement using discussion-based methods. Nine primary research questions were identified that formed the scope and structure of the recommendations on how to select items and implement item lists created from item libraries. These recommendations address methods to drive item selection, plan the structure and analysis of item lists, and facilitate their use in conjunction with other measures. The findings resulted in high-level, instrument-agnostic recommendations on the use of item-library-derived item lists in oncology trials.

Earthquake-induced damage to concrete shear walls will manifest in the form of cracks and spalled regions. This damage will naturally influence the performance of anchors installed in the wall face. Conversely, anchors could affect the crack pattern developing in walls. To study the relationship between anchors and shear walls subjected to seismic-induced damage, two identical full-scale reinforced concrete shear walls with low aspect ratios were designed and tested under equivalent seismic loads. One of the walls was tested absent axial load to investigate the effect of compression on wall damage. Both walls exhibited appreciable deformation capacity and significant energy dissipation. Buckling and rupture of the longitudinal reinforcing bars after diagonal cracking and concrete crushing resulted in mixed shear-fexure failure modes. Results from these tests are compared with prior tests on a fexure-dominated wall, with particular attention given to the attained displacement ductility. Finally, the strut-and-tie and shearstrength models used to estimate wall strength and failure mode demonstrate consistent comparison with the experimental results. Keywords: anchor; concrete damage; crack pattern; crack width; full-scale shear wall; performance limit state; strut and tie.

Cracks and damage occurring in concrete members as a result of earthquake-induced ground motion may impact the performance of anchors installed in those members. To investigate this issue, an earlier experimental study examined the response of tension-loaded anchors installed in a slender full-scale reinforced concrete shear wall subjected to cyclic loading. The present efort extends that investigation to anchors installed in full-scale low-aspect-ratio concrete shear walls. The test walls, described in a companion paper, were detailed with minimum horizontal reinforcement to ensure a range of crack types with appreciable distribution throughout the wall. The load and displacement histories of the anchors are analyzed to characterize their performance under a variety of concrete damage states. The anchor axial strength reduction is estimated at key performance limit states typical of concrete shear walls to provide a link between structural performance and anchor response. Finally, the residual tension capacity of the anchors is assessed in contrast with the concrete damage distribution in the wall. Keywords: anchor testing; anchors; concrete damage; crack pattern; crack width; performance limit state; reinforced concrete shear wall.

Robust numerical representation of the behavior of reinforced concrete (RC) shear walls under simulated earthquake action is critical to support an accurate evaluation of the performance of concrete buildings. Reliable damage predictions of concrete shear walls are also essential to understand the response of components attached to walls via anchors. Previous studies have shown that anchor load capacity is reduced in the presence of concrete damage. Accordingly, current U.S. building code requirements prohibit anchor installation in sections of walls where yielding of the reinforcement is expected. The aim of this requirement is to minimize the potential for anchorage failure during a seismic event. Identification of concrete damage in shear walls of varying characteristics is therefore relevant to anchor performance. In this regard, the present paper describes a parametric study performed using a multiple vertical-line element model able to couple shear-flexure interaction. The aim of the study is to qualitatively identify regions of severe damage in concrete shear walls of varied geometric and detailing characteristics and thus better assist engineers in adhering with current code requirements. Results show that the regions where large damage is expected define a plastic hinge length and include the boundary elements in slender walls and the diagonal compression struts in squat walls. This information is used to suggest anchor installation locations to assure their robust performance when attaching nonstructural components and systems to RC shear walls subject to seismic loading.