Item Library Research Articles

Validation of the German patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE™)

Integrating the patient's perspective has become an increasingly important component of adverse event reporting. The National Cancer Institute has developed a Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™). This instrument has been translated into German and linguistically validated; however, its quantitative measurement properties have not been evaluated. A German language survey that included 31 PRO-CTCAE items, as well as the EORTC QLQ-C30 and the Oral Mucositis Daily Questionnaire (OMDQ), was distributed at 10 cancer treatment settings in Germany and Austria. Item quality was assessed by analysis of acceptability and comprehensibility. Reliability was evaluated by using Cronbach's' alpha and validity by principal components analysis (PCA), multitrait-multimethod matrix (MTMM) and known groups validity techniques. Of 660 surveys distributed to the study centres, 271 were returned (return rate 41%), and data from 262 were available for analysis. Participants' median age was 59.7 years, and 69.5% of the patients were female. Analysis of item quality supported the comprehensibility of the 31 PRO-CTCAE items. Reliability was very good; Cronbach's' alpha correlation coefficients were >0.9 for almost all item clusters. Construct validity of the PRO-CTCAE core item set was shown by identifying 10 conceptually meaningful item clusters via PCA. Moreover, construct validity was confirmed by the MTMM: monotrait-heteromethod comparison showed 100% high correlation, whereas heterotrait-monomethod comparison indicated 0% high correlation. Known groups validity was supported; PRO-CTCAE scores were significantly lower for those with impaired versus preserved health-related quality of life. A set of 31 items drawn from the German PRO-CTCAE item library demonstrated favourable measurement properties. These findings add to the body of evidence that PRO-CTCAE provides a rigorous method to capture patient self-reports of symptomatic toxicity for use in cancer clinical trials.

Mode equivalence and acceptability of tablet computer-, interactive voice response system-, and paper-based administration of the U.S. National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

BackgroundPRO-CTCAE is a library of items that measure cancer treatment-related symptomatic adverse events (NCI Contracts: HHSN261201000043C and HHSN 261201000063C). The objective of this study is to examine the equivalence and acceptability of the three data collection modes (Web-enabled touchscreen tablet computer, Interactive voice response system [IVRS], and paper) available within the US National Cancer Institute (NCI) Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) measurement system.MethodsParticipants (n = 112; median age 56.5; 24 % high school or less) receiving treatment for cancer at seven US sites completed 28 PRO-CTCAE items (scoring range 0–4) by three modes (order randomized) at a single study visit. Subjects completed one page (approx. 15 items) of the EORTC QLQ-C30 between each mode as a distractor. Item scores by mode were compared using intraclass correlation coefficients (ICC); differences in scores within the 3-mode crossover design were evaluated with mixed-effects models. Difficulties with each mode experienced by participants were also assessed.Results103 (92 %) completed questionnaires by all three modes. The median ICC comparing tablet vs IVRS was 0.78 (range 0.55–0.90); tablet vs paper: 0.81 (0.62–0.96); IVRS vs paper: 0.78 (0.60–0.91); 89 % of ICCs were ≥0.70. Item-level mean differences by mode were small (medians [ranges] for tablet vs. IVRS = −0.04 [−0.16–0.22]; tablet vs paper = −0.02 [−0.11–0.14]; IVRS vs paper = 0.02 [−0.07–0.19]), and 57/81 (70 %) items had bootstrapped 95 % CI around the effect sizes within +/−0.20. The median time to complete the questionnaire by tablet was 3.4 min; IVRS: 5.8; paper: 4.0. The proportion of participants by mode who reported “no problems” responding to the questionnaire was 86 % tablet, 72 % IVRS, and 98 % paper.ConclusionsMode equivalence of items was moderate to high, and comparable to test-retest reliability (median ICC = 0.80). Each mode was acceptable to a majority of respondents. Although the study was powered to detect moderate or larger discrepancies between modes, the observed ICCs and very small mean differences between modes provide evidence to support study designs that are responsive to patient or investigator preference for mode of administration, and justify comparison of results and pooled analyses across studies that employ different PRO-CTCAE modes of administration.Trial registrationNCT Clinicaltrials.gov identifier: NCT02158637

Linguistic validation of the Spanish version of the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

The U.S. NCI's PRO-CTCAE is a library of self-report items for assessing symptomatic adverse events in cancer clinical trials from the patient perspective. The aim of this study was to translate and linguistically validate a Spanish version. PRO-CTCAE's 124 items were translated from English into Spanish using multiple forward and back translations. Native Spanish speakers undergoing cancer treatment were enrolled at six cancer treatment sites. Participants each completed approximately 50 items and were then interviewed using cognitive probes. The interviews were analyzed at the item level by linguistic themes, and responses were examined for evidence of equivalence to English. Items for which ≥20% of participants experienced difficulties were reviewed, and phrasing was revised and then retested in subsequent interviews. Items where <20% of respondents experienced difficulties were also reviewed and were considered for rephrasing and retesting. One hundred nine participants from diverse Spanish-speaking countries were enrolled (77 in Round 1 and 32 in Round 2). A majority of items were well comprehended in Round 1. Two items presented difficulties in ≥20% of participants and were revised/retested without further difficulties. Two items presented difficulties in <20%, and when retested exhibited no further difficulties. Two items presented difficulties in <20%, but were not revised due to lack of alternatives. Sixteen items presented difficulties in ≤12% and were not revised because difficulties were minor. The Spanish PRO-CTCAE has been developed and refined for use in Spanish-speaking populations, with high levels of comprehension and equivalence to the English PRO-CTCAE. ClinicalTrials.gov:NCT01436240.

Formative research on patient experiences with cancer care.

274 Background: The objectives of the formative research were to identify key themes of patient-centered cancer care and determine the best method to collect data to develop the CAHPS Survey for Cancer Care Prototype. This survey seeks to measure aspects of care most important to patients and allow comparisons of those aspects across treatment centers and treatment modalities. Methods: We developed a library of 1,781 items from CAHPS and cancer care surveys. We conducted 14 focus groups with patients (including 2 conducted in Spanish) who had received cancer care in the past 12 months, and 2 focus groups involving family members of cancer patients. We met with 10 experts representing patients and survivors, or who had expertise in quality improvement, oncology, shared decision-making and patient safety to obtain feedback on the development of the survey, potential markets for the instrument, and to assist with overall strategy. Finally, we conducted separate interviews with 5 stakeholder groups representing oncology associations to obtain feedback on focal provider, attribution and sampling. Results: While the focus group results validated findings from the item library, new concepts also emerged, such as the need for having a plan of care. Patients most readily identified with a team of providers, rather than a single provider. The two most important domains to patients were (1) how well the cancer care team communicates with patients and (2) whether the cancer care team keeps patients informed about cancer treatment. Patients were also interested in care coordination, access to information, providers who are up-to-date, and shared decision-making. Stakeholder interviews noted that survey results would be most valuable if presented by treatment modality: medical, radiation, and surgical oncology. Conclusions: These findings suggest that cancer care is best for the patient when providers are knowledgeable and straightforward with medical information, yet can demonstrate empathy and compassion.

Linguistic and content validation of a German-language PRO-CTCAE-based patient-reported outcomes instrument to evaluate the late effect symptom experience after allogeneic hematopoietic stem cell transplantation

PurposeThe aim of this sequential mixed methods study was to develop a PRO-CTCAE (Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events)-based measure of the symptom experience of late effects in German speaking long-term survivors of allogeneic stem cell transplantation (SCT), and to examine its content validity. MethodsThe US National Cancer Institute's PRO-CTAE item library was translated into German and linguistically validated. PRO-CTCAE symptoms prevalent in ≥50% of survivors (n = 15) and recognized in its importance by SCT experts (n = 9) were identified. Additional concepts relevant to the symptom experience and its consequences were elicited. Content validity of the PROVIVO (Patient-Reported Outcomes of long-term survivors after allogeneic SCT) instrument was assessed through an additional round of cognitive debriefing in 15 patients, and item and scale content validity indices by 9 experts. ResultsPROVIVO is comprised of a total of 49 items capturing the experience of physical, emotional and cognitive symptoms. To improve the instrument's utility for clinical decision-making, questions soliciting limitations in activities of daily living, frequent infections, and overall well-being were added. Cognitive debriefings demonstrated that items were well understood and relevant to the SCT survivor experience. Scale Content Validity Index (CVI) (0.94) and item CVI (median = 1; range 0.75–1) were very high. ConclusionsQualitative and quantitative data provide preliminary evidence supporting the content validity of PROVIVO and identify a PRO-CTCAE item bundle for use in SCT survivors. A study to evaluate the measurement properties of PROVIVO and to examine its capacity to improve survivorship care planning is underway.

Математична модель напівпровідникового формувача розрядних імпульсів у високочастотній електротехнологічній системі

A mathematical model of electromagnetic processes in thyristor conditioners that use circuit charge, discharge and overcharge additional storage capacitor for electric- load. The possibility to adjust the output voltage of these generators by making use of the charger choke and change the time interval between inclusions thyristors for overcharging condenser and his next charge. It was also found that computer simulations of electromagnetic processes in electric circuits , links which have a large number of independent reactive elements , distributed usage clearing system with Matlab software package Simulink and Expansion package SimPowerSystems, which, in addition to an extensive library of electrical items and blocks with blocks for simulation of semiconductor switches and algorithms management.

Cognitive interviewing of the US National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

The National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) is a library of question items that enables patient reporting of adverse events (AEs) in clinical trials. This study contributes content validity evidence of the PRO-CTCAE by incorporating cancer patient input of the relevance and comprehensiveness of the item library. Cognitive interviews were conducted among patients undergoing chemotherapy or radiation therapy at multiple sites to evaluate comprehension, memory retrieval, judgment, and response mapping related to AE terms (e.g., nausea), attribute terms (regarding frequency, severity, or interference), response options, and recall period. Three interview rounds were conducted with ≥20 patients completing each item per round. Items were modified and retested if ≥3 patients exhibited cognitive difficulties or if experienced by ≤25% patients. One hundred and twenty-seven patients participated (35% ≤high school, 28% non-white, and 59% female). Most AE terms (63/80) generated no cognitive difficulties. The remaining 17 were modified without further difficulties by Round 3. Terms were comprehended regardless of education level. Attribute terms and response options required no modifications. Patient adherence to recall period (7 days) was improved when the reference period was incorporated. This study provides evidence confirming comprehension of the US English language versions of items in the PRO-CTCAE library for measuring symptomatic AEs from the patient perspective within the context of cancer treatment. Several minor changes were made to the items to improve item clarity, comprehension, and ease of response judgment. This study helps to establish the content validity of PRO-CTCAE items for patient reporting of AEs during cancer treatment.

Individualized behavior management program for Alzheimer's/dementia residents using behavior-based ergonomic therapies.

Person-centered, nonpharmacological interventions for managing Alzheimer's/dementia-related behavioral disturbances have received significant attention. However, such interventions are quite often of a single type limiting their benefits. We develop a comprehensive nonpharmacological intervention, the Behavior-Based Ergonomic Therapy (BBET), which consists of multiple therapies. This low-cost, 24/7 program uses learning, personality, and behavioral profiles and cognitive function of each resident to develop a set of individualized therapies. These therapies are made available through an accessible resource library of music and video items, games and puzzles, and memory props to provide comfort or stimulation depending on an individual resident's assessment. The quantitative and qualitative benefits of the BBET were evaluated at the dementia care unit in a not-for-profit continuing care retirement community in west central Ohio. The 6-month pilot study reduced falls by 32.5% and markedly reduced agitation through increased resident engagement.

Stakeholder perspectives on implementing the National Cancer Institute’s patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

The National Cancer Institute (NCI) is developing a patient-reported version of its Common Terminology Criteria for Adverse Events, called the "PRO-CTCAE." The PRO-CTCAE consists of a library of patient-reported items which can be administered in clinical trials to directly capture the patient experience of adverse events during cancer treatment, as well as a software platform for administering these items via computer or telephone. In order to better understand the impressions of stakeholders involved in cancer clinical research about the potential value of the PRO-CTCAE approach to capturing adverse event information in clinical research, as well as their perspectives about barriers and strategies for implementing the PRO-CTCAE in NCI-sponsored cancer trials, a survey was conducted. A survey including structured and open-ended questions was developed to elicit perceptions about the use of patient-reported outcomes (PROs) for adverse event reporting, and to explore logistical considerations for implementing the PRO-CTCAE in cancer trials. The survey was distributed electronically and by paper to a convenience sample of leadership and committee members in the NCI's cooperative group network, including principal investigators, clinical investigators, research nurses, data managers, patient advocates, and representatives of the NCI and Food and Drug Administration. Between October, 2008 through February, 2009, 727 surveys were collected. Most respondents (93%) agreed that patient reporting of adverse symptoms would be useful for improving understanding of the patient experience with treatment in cancer trials, and 88%, 80%, and 76%, respectively, endorsed that administration of PRO-CTCAE items in clinical trials would improve the completeness, accuracy, and efficiency of symptom data collection. More than three fourths believed that patient reports would be useful for informing treatment dose modifications and towards FDA regulatory evaluation of drugs. Eighty-eight percent felt that patients in clinical trials would be willing to self-report adverse symptoms at clinic visits via computer, and 68% felt patients would self-report weekly from home via the internet or an automated telephone system. Lack of computers and limited space and personnel were seen as potential barriers to in-clinic self-reporting, but these were judged to be surmountable with adequate funding. The PRO-CTCAE items and software are viewed by a majority of survey respondents as a means to improve adverse event data quality and comprehensiveness, enhance clinical decision-making, and foster patient-clinician communication. Research is ongoing to assess the measurement properties and feasibility of implementing this measure in cancer clinical trials.

The Patient-Reported Outcomes Measurement Information System (PROMIS)

The National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) Roadmap initiative (www.nihpromis.org) is a 5-year cooperative group program of research designed to develop, validate, and standardize item banks to measure patient-reported outcomes (PROs) relevant across common medical conditions. In this article, we will summarize the organization and scientific activity of the PROMIS network during its first 2 years. The network consists of 6 primary research sites (PRSs), a statistical coordinating center (SCC), and NIH research scientists. Governed by a steering committee, the network is organized into functional subcommittees and working groups. In the first year, we created an item library and activated 3 interacting protocols: Domain Mapping, Archival Data Analysis, and Qualitative Item Review (QIR). In the second year, we developed and initiated testing of item banks covering 5 broad domains of self-reported health. The domain mapping process is built on the World Health Organization (WHO) framework of physical, mental, and social health. From this framework, pain, fatigue, emotional distress, physical functioning, social role participation, and global health perceptions were selected for the first wave of testing. Item response theory (IRT)-based analysis of 11 large datasets supplemented and informed item-level qualitative review of nearly 7000 items from available PRO measures in the item library. Items were selected for rewriting or creation with further detailed review before the first round of testing in the general population and target patient populations. The NIH PROMIS network derived a consensus-based framework for self-reported health, systematically reviewed available instruments and datasets that address the initial PROMIS domains. Qualitative item research led to the first wave of network testing which began in the second year.

Discrimination and classification of buried unexploded ordnance using magnetometry

Magnetic surveys are quite successful at locating buried steel objects, including unexploded ordnance (UXO). However, many of the anomalies apparent in a magnetic image of a contaminated area are from metallic debris, shrapnel, and geological variations in ferromagnetic concentration. Observations are usually made in the far-field of the object so that, in most cases, we can only recover the dipole moment of a buried item. Due to self-demagnetization effects, the magnitude and direction of induced magnetism varies significantly with ordnance orientation. This results in an infinite number of ordnance-like objects that can reproduce a given dipole moment. To discriminate, we define a library of ordnance items expected to occur in the area and find how closely each recovered moment matches one of the UXOs in this library. We define the size of this mismatch as the remanent magnetization and produce a prioritized dig-list on the assumption that items with lower remanence are more likely to be UXO. Such a ranking scheme proves to be very effective when implemented at two sites in Montana. The analysis reveals that live-site and emplaced UXO have significantly different remanence and implies that previous tests of magnetic discrimination performance on seeded sites have been overly pessimistic.

Noam Chomsky and the Manufacture of Consent for American Foreign Policy

Few names of academic scholars are so well recognized all around the world as that of Noam Chomsky. He is listed as the author or coauthor of well over 1,000 items in the online database of the Library of Congress. The range of topics covered in these books, videos, and audiotapes reveals at least three different Chomskys: the linguistic scholar internationally recognized for his theory of transformational grammar and generative syntax, the political activist inspired by the writings of Mikhail Bakunin and Anton Pannekoek, and the analyst of media performance who (together with Edward S. Herman) promulgated a “propaganda model” as an alternative to the conception of the media as “adversarial,” the one to which journalists, jurists, and communication scholars typically subscribe. It is this third role, which accounts for roughly 80% of the Library of Congress items, that apparently moved the editor of this journal to suggest a review of work by or about Chomsky. Having dutifully absorbed the contents of what looms as an unceasing, still continuing, flood of books, pamphlets, articles, and interviews—including some on C-Span, public radio, and the Internet—we refrain from reviewing each individually. This becomes unnecessary inasmuch as, at least on the subjects of greatest concern to communication scholars, almost all make use of the same materials and dwell on the same themes with surprisingly little variation. Endlessly repetitive, they do, however, when considered in their entirety, confirm Chomsky’s contention that despite his academic preoccupation with language, he completely separates his role as linguistics scholar from those of media critic and political activist. It is in the two latter roles that he has expressed his anarchist creed and developed, in conformity with it, a communication model that concedes no legitimacy to state authority and certainly none to any kind of violence even when used to counter something far worse. The connection to ideology does not, of course, invalidate the model. Social science inquiry generally and the study of mass communication, in particular, have often been driven by meliorative impulses. They are not separated by an impenetrable wall. Be this as it may, Chomsky’s model, like any model, still has to be judged not just, or even primarily, on its suitability as a club for beating up on the media but rather on its theoretical adequacy, which is to say, on how closely it approximates how they actually function.

Using the OCLC GOVDOC service

Reports on the implementation and use of the OCLC GOVDOC, the online service providing cataloguing for federal government documents, and finding cost‐efficient and productive means by which to use the records. Describes matching the GOVDOC records with Library of Congress collection items and Superintendent of Documents (SuDoc) items. Details the procedure for cataloguing the new depository titles and to transform the cataloguing for individual slip laws.

ESTIMATION OF LATENT ABILITY USING A RESPONSE PATTERN OF GRADED SCORES1

ABSTRACTEstimation of latent ability using the entire response pattern of free‐response items is discussed, first in the general case and then in the case where the items are scored in a graded way, especially when the thinking process required for solving each item is assumed to be homogeneous.The maximum likelihood estimator, the Bayes modal estimator, and the Bayes estimator obtained by using the mean‐square error multiplied by the density function of the latent variate as the loss function are taken as our estimators. Sufficient conditions for the existence of a unique maximum likelihood estimator and a unique Bayes modal estimator are formulated with respect to an individual item rather than with respect to a whole set of items, which are useful especially in the situation where we are free to choose optimal items for a particular examinee out of the item library in which a sufficient number of items are stored with reliable quality controls.Advantages of the present methods are investigated by comparing them with those which make use of conventional dichotomous items or test scores, theoretically as well as empirically, in terms of the amounts of information, the standard errors of estimators, and the mean‐square errors of estimators. The utility of the Bayes modal estimator as a computational compromise for the Bayes estimator is also discussed and observed. The relationship between the formula for the item characteristic function and the philosophy of scoring is observed with respect to dichotomous items.

The Museo Del Patriarca of Valencia

Spain is probably second to no country in Europe in the possession of splendid ecclesiastical collections and museums. In the field of conservation and restoration, much valuable work has been done within the past decade so that these treasures are now more readily available to the scholarly public for study and enjoyment.The so-called Museo del Patriarca is a part of the Real Colegio y Seminario de Corpus Christi de Valencia, to give it its proper name. An oasis of peace and the pleasures of the spirit in the heart of the city, it looks out across the square to the University which in a sense it complements. The library, archives, and musical collection of rare and early items alone would constitute a valid claim to fame. The church with its numerous chapels, also endowed by the founder and richly decorated, is important in the world of Catholicism for its special cult of the Eucharist, in rites which are solemnized with the utmost pomp and splendor. The organ is superb and the music famous.