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Starburst amacrine cells are a prominent neuron type in the mammalian retina that has been well-studied for its role in direction-selective information processing. One specific property of these cells is that their dendrites tightly stratify at specific depths within the inner plexiform layer (IPL), which, together with their unique expression of choline acetyltransferase (ChAT), has made them the most common depth marker for studying other retinal neurons in the IPL. This stratifying property makes it unexpected that they could routinely have dendrites reaching into the nuclear layer or that they could have somatic contact specializations, which is exactly what we have found in this study. Specifically, an electron microscopic image volume of sufficient size from a mouse retina provided us with the opportunity to anatomically observe both microscopic details and collective patterns, and our detailed cell reconstructions revealed interesting cell-cell contacts between starburst amacrine neurons. The contact characteristics differ between the respective On and Off starburst amacrine subpopulations, but both occur within the soma layers, as opposed to their regular contact laminae within the inner plexiform layer.

The concept o f health-related quality of life has a long history in the field o f oncology treatment and research. We present a brief history o f how the concept has evolved in oncology and the sentinel events in that process. We then focus on advances in measurement science as applied to health-related quality o f life measures and argue that a compelling new set of measurement tools is now available, including brief, generic measures with good psychometric qualities (exemplified by the new PROMIS measures and the possibility of a common metric spanning all diseases). The last section of the paper turns to emerging opportunities for these measures, including in clinical trials, healthcare reform, and regulatory deliberations. Our conclusion is that health-related quality of life is more important today than it has ever been, and that the time has come for an even wider adoption of the new measures. [ABSTRACT FROM AUTHOR]

Background The National Cancer Institute's Symptom Management and Health-Related Quality of Life Steering Committee held a clinical trials planning meeting (September 2011) to identify a core symptom set to be assessed across oncology trials for the purposes of better understanding treatment efficacy and toxicity and to facilitate cross-study comparisons. We report the results of an evidence-synthesis and consensus-building effort that culminated in recommendations for core symptoms to be measured in adult cancer clinical trials that include a patient-reported outcome (PRO). Methods We used a data-driven, consensus-building process. A panel of experts, including patient representatives, conducted a systematic review of the literature (2001-2011) and analyzed six large datasets. Results were reviewed at a multistakeholder meeting, and a final set was derived emphasizing symptom prevalence across diverse cancer populations, impact on health outcomes and quality of life, and attribution to either disease or anticancer treatment. Results We recommend that a core set of 12 symptoms--specifically fatigue, insomnia, pain, anorexia (appetite loss), dyspnea, cognitive problems, anxiety (includes worry), nausea, depression (includes sadness), sensory neuropathy, constipation, and diarrhea --be considered for inclusion in clinical trials where a PRO is measured. Inclusion of symptoms and other patient-reported endpoints should be well justified, hypothesis driven, and meaningful to patients. Conclusions This core set will promote consistent assessment of common and clinically relevant disease- and treatment-related symptoms across cancer trials. As such, it provides a foundation to support data harmonization and continued efforts to enhance measurement of patient-centered outcomes in cancer clinical trials and observational studies. [ABSTRACT FROM AUTHOR]

There is no consensus as to what symptoms or quality-of-life (QOL) domains should be measured as patient-reported outcomes (PROs) in ovarian cancer clinical trials. A panel of experts convened by the National Cancer Institute reviewed studies published between January 2000 and August 2011. The results were included in and combined with an expert consensus-building process to identify the most salient PROs for ovarian cancer clinical trials. We identified a set of PROs specific to ovarian cancer: abdominal pain, bloating, cramping, fear of recurrence/disease progression, indigestion, sexual dysfunction, vomiting, weight gain, and weight loss. Additional PROs identified in parallel with a group charged with identifying the most important PROs across cancer types were anorexia, cognitive problems, constipation, diarrhea, dyspnea, fatigue, nausea, neuropathy, pain, and insomnia. Physical and emotional domains were considered to be the most salient domains of QOL. Findings of the review and consensus process provide good support for use of these ovarian cancer-specific PROs in ovarian cancer clinical trials. [ABSTRACT FROM AUTHOR]

Objective: The quality of our daily social interactions—including perceptions of support, feelings of loneliness, and distress stemming from negative social exchanges—influence physical health and well-being. Despite the importance of social relationships, brief yet precise unidimensional scales that assess key aspects of social relationship quality are lacking. As part of the National Institute of Health (NIH) Toolbox for the Assessment of Neurological and Behavioral Function, we developed brief self-report scales designed to assess aspects of social support, companionship, and social distress across age cohorts. This article details the development and psychometric testing of the adult NIH Toolbox Social Relationship scales. Methods: Social relationship concepts were selected, and item sets were developed and revised based on expert feedback and literature review. Items were then tested across a community-dwelling U.S. Internet panel sample of adults aged 18 and above (N = 692) using traditional (classic) psychometric methods and item response theory approaches to identify items for inclusion in 5-8 item unidimensional scales. Finally, concurrent validity of the newly developed scales was evaluated with respect to their interrelationships with classic social relationship validation instruments. Results: Results provide support for the internal reliability and concurrent validity of resulting self-report scales assessing Emotional Support, Instrumental Support, Friendship, Loneliness, Perceived Rejection, and Perceived Hostility. Conclusion: These brief social relationship scales provide the pragmatic utility and enhanced precision needed to promote future epidemiological and social neuroscience research on the impact of social relationships on physical and emotional health outcomes. [ABSTRACT FROM AUTHOR]

The Patient-Reported Outcomes Measurement Information System (PROMIS) was developed as one of the first projects funded by the NIH Roadmap for Medical Research Initiative to re-engineer the clinical research enterprise. The primary goal of PROMIS is to build item banks and short forms that measure key health outcome domains that are manifested in a variety of chronic diseases which could be used as a "common currency" across research projects. To date, item banks, short forms and computerized adaptive tests (CAT) have been developed for 13 domains with relevance to pediatric and adult subjects. To enable easy delivery of these new instruments, PROMIS built a web-based resource (Assessment Center) for administering CATs and other self-report data, tracking item and instrument development, monitoring accrual, managing data, and storing statistical analysis results. Assessment Center can also be used to deliver custom researcher developed content, and has numerous features that support both simple and complicated accrual designs (branching, multiple arms, multiple time points, etc.). This paper provides an overview of the development of the PROMIS item banks and details Assessment Center functionality. [ABSTRACT FROM AUTHOR]

The article discusses a study on the agreement of reports from pediatric brain tumor patients and their parents as examined using the Pediatric Functional Assessment of Cancer Therapy-Childhood Brain Tumor Survivors (pedsFACT-BrS). A multicenter project to acquire statistically adequate populations of child and adolescent brain tumor (BT) patients was conducted. The study cited that child and adolescent BT patients' parent proxy reports provide clinicians with valid information on the overall quality of life in relation to general health.

The article discusses the quality-of-life (QOL) line items on the functional assessment of cancer therapy-ovarian (FACT-O) which were associated with low QOL in women who were receiving chemotherapy for ovarian cancer. QOL assessment is the key factor in assessing cancer burden and the effect of treatment. A survey with patients of stage III or IV ovarian cancer was conducted and it was concluded that a large proportion of women reported problems that were amenable to clinical interventions.

Ovarian germ cell cancer is a rare tumor. Approximately 1000 to 2000 women in the United States will be diagnosed with ovarian germ cell cancer in 2007. When it occurs, it is usually diagnosed before age 20 and is highly responsive to therapy. Most patients live a full life span. The 5-year relative survival rate is 95%. This article describes differences in quality of life issues between ovarian germ cell cancer survivors and young women who have not experienced cancer and were matched to survivors on age, education, and race (by the acquaintance control method). Survivors and controls completed mail and phone surveys. A multivariable logistic regression model was adjusted for age, education, household income, marital status, and perception of fertility. Compared to controls, germ cell cancer survivors expressed more reproductive concerns and reported worse sexual functioning, but they also experienced greater appreciation of life and more affective (i.e., emotional) social support. Future research is suggested to test interventions to enhance quality of life for ovarian germ cell cancer survivors in the areas of sexual functioning and reproductive concerns, but only for survivors who are in distress or in need of the support. Potential screening questions are offered for clinicians, but further research is needed to assess their validity as screening tools. [ABSTRACT FROM AUTHOR]

We expanded an existing 33-item physical function (PF) item bank with a sufficient number of items to enable computerized adaptive testing (CAT). Ten items were written to expand the bank and the new item pool was administered to 295 people with cancer. For this analysis of the new pool, seven poorly performing items were identified for further examination. This resulted in a bank with items that define an essentially unidimensional PF construct, cover a wide range of that construct, reliably measure the PF of persons with cancer, and distinguish differences in self-reported functional performance levels. We also developed a 5-item (static) assessment form (‘BriefPF’) that can be used in clinical research to express scores on the same metric as the overall bank. The BriefPF was compared to the PF-10 from the Medical Outcomes Study SF-36. Both short forms significantly differentiated persons across functional performance levels. While the entire bank was more precise across the PF continuum than either short form, there were differences in the area of the continuum in which each short form was more precise: the BriefPF was more precise than the PF-10 at the lower functional levels and the PF-10 was more precise than the BriefPF at the higher levels. Future research on this bank will include the development of a CAT version, the PF-CAT. [ABSTRACT FROM AUTHOR]

This study investigated whether the opportunity to obtain Continuing Medical Education (CME) credit together with a five-dollar bill increased response rates and questionnaire completion rates in a physician survey involving mailed questionnaires. One thousand, three hundred and fourteen cardiologists, family practitioners, general internists (non-surgeons) and 264 vascular surgeons randomly identified from the American Medical Association database participated. After two, of up to four, questionnaire mailings, the opportunity to obtain CME credit and a five-dollar bill were included with questionnaire mailings. Among non-surgeons, 26.5% responded to pre-incentive mailings and 30.2% of those initially unresponsive replied after the interventions. Among surgeons, 39% responded to pre-incentive mailings and 32.7% of those initially unresponsive replied after the interventions. In conclusion, the opportunity to receive CME credit combined with a small monetary incentive is an effective motivation for physicians participating in a study involving mailed questionnaires. [ABSTRACT FROM AUTHOR]

Social functioning is an essential but poorly understood component of health-related quality of life (HRQOL) for people with Huntington disease (HD). We report on the psychometric properties of 2 Neuro-QoL patient-reported outcome measures to assess social functioning in HD. Persons with prodromal (n = 198) or manifest HD (n = 195 early and n = 117 late) completed Neuro-QoL Ability to Participate in Social Roles and Activities, and Satisfaction with Social Roles and Activities. Items from 2 generic HRQOL patient-reported outcome measures were used to create a social functioning composite score; items from the Unified Huntington's Disease Rating Scale and Problem Behaviors Assessment Scale were used to create a clinician-rated composite score of social function. Internal consistencies for the scores on the Neuro-QoL measures were excellent (> .88). Computer adaptive test administration had some advantages over computer-administered static Short Forms. Validity was supported by significant associations between the scores on the Neuro-QoL measures and other self- and clinician-reports of social function. Individuals with prodromal HD had better social functioning than the manifest HD groups; individuals with late-HD had less satisfaction and ability to participate in social roles and activities than the other 2 groups. Neuro-QoL provides brief, reliable scores of social functioning that measure ability to participate in, and satisfaction with, social roles and activities in persons with prodromal and manifest HD. In addition, test score interpretations of these measures support their validity in people with prodromal and manifest HD. These measurement tools add breadth to treatment outcome measures in HD and can increase understanding of the social implications of living with HD. (PsycINFO Database Record [ABSTRACT FROM AUTHOR]

The article presents a randomized phase three trial on the effectiveness of sorafenib and axitinib in patients with metastatic renal cell carcinoma (AXIS). The clinical test used sorafenib and axitinib, and participants were assessed by masked, analysed by intention of treating, and independent radiology review. The study treatment was stopped due to toxic effects in 14 patients or four percent patients treated with axitinib and 29 or eight percent patients treated with sorafenib.

Background: To develop and validate a quality of life subscale for patients with esophageal cancer to be used with the Functional Assessment of Cancer Therapy-General (FACT-G)., Methods: Prospective cohort study of patients with esophageal cancer treated with surgery alone or neoadjuvant chemoradiotherapy and surgery evaluating the validity, internal consistency, and responsiveness to change of the FACT-Esophageal (FACT-E) when comparing it with the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ 30) and esophageal (OES 24) as well as clinical factors., Results: The FACT-E demonstrated very good convergent and divergent validity when compared with the EORTC QLQ30 and OES 24 and clinical variables. Internal consistency was also good with coefficient alpha > 0.70 for all subscales and individual items. Stability coefficients were > 0.80. Changes in clinical status were reflected in changes in FACT-E scores demonstrating responsiveness to change, particularly in patients receiving neoadjuvant chemoradiotherapy before surgery., Conclusions: The FACT-E met or exceeded all standards for validity, providing an option to measure health-related quality of life for different treatment strategies for esophageal cancer.