Search

Background This study compares classical test theory and item response theory frameworks to determine reliable change. Reliable change followed by anchoring to the change in categorically distinct responses on a criterion measure is a useful method to detect meaningful change on a target measure. Methods Adult cancer patients were recruited from five cancer centers. Baseline and follow-up assessments at 6 weeks were administered. We investigated short forms derived from PROMIS® item banks on anxiety, depression, fatigue, pain intensity, pain interference, and sleep disturbance. We detected reliable change using reliable change index (RCI). We derived the T-scores corresponding to the RCI calculated under IRT and CTT frameworks using PROMIS® short forms. For changes that were reliable, meaningful change was identified using patient-reported change in PRO-CTCAE by at least one level. For both CTT and IRT approaches, we applied one-sided tests to detect reliable improvement or worsening using RCI. We compared the percentages of patients with reliable change and reliable/meaningful change. Results The amount of change in T score corresponding to RCICTT of 1.65 ranged from 5.1 to 9.2 depending on domains. The amount of change corresponding to RCIIRT of 1.65 varied across the score range, and the minimum change ranged from 3.0 to 8.2 depending on domains. Across domains, the RCICTT and RCIIRT classified 80% to 98% of the patients consistently. When there was disagreement, the RCIIRT tended to identify more patients as having reliably changed compared to RCICTT if scores at both timepoints were in the range of 43 to 78 in anxiety, 45 to 70 in depression, 38 to 80 in fatigue, 35 to 78 in sleep disturbance, and 48 to 74 in pain interference, due to smaller standard errors in these ranges using the IRT method. The CTT method found more changes compared to IRT for the pain intensity domain that was shorter in length. Using RCICTT, 22% to 66% had reliable change in either direction depending on domains, and among these patients, 62% to 83% had meaningful change. Using RCIIRT, 37% to 68% had reliable change in either direction, and among these patients, 62% to 81% had meaningful change. Conclusion Applying the two-step criteria demonstrated in this study, we determined how much change is needed to declare reliable change at different levels of baseline scores. We offer reference values for percentage of patients who meaningfully change for investigators using the PROMIS instruments in oncology.

Purpose The standard recall period for the patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE®) is the past 7 days, but there are contexts where a 24-hour recall may be desirable. The purpose of this analysis was to investigate the reliability and validity of a subset of PRO-CTCAE items captured using a 24-hour recall. Methods 27 PRO-CTCAE items representing 14 symptomatic adverse events (AEs) were collected using both a 24-hour recall (24 h) and the standard 7 day recall (7d) in a sample of patients receiving active cancer treatment (n = 113). Using data captured with a PRO-CTCAE-24h on days 6 and 7, and 20 and 21, we computed intra-class correlation coefficients (ICC); an ICC ≥ 0.70 was interpreted as demonstrating high test–retest reliability. Correlations between PRO-CTCAE-24h items on day 7 and conceptually relevant EORTC QLQ-C30 domains were examined. In responsiveness analysis, patients were deemed changed if they had a one-point or greater change in the corresponding PRO-CTCAE-7d item (from week 0 to week 1). Results PRO-CTCAE-24h captured on two consecutive days demonstrated that 21 of 27 items (78%) had ICCs ≥ 0.70 (day 6/7 median ICC 0.76), (day 20/21 median ICC 0.84). Median correlation between attributes within a common AE was 0.75, and the median correlation between conceptually relevant EORTC QLQ-C30 domains and PRO-CTCAE-24 h items captured on day 7 was 0.44. In the analysis of responsiveness to change, the median standardized response mean (SRM) for patients with improvement was − 0.52 and that for patients with worsening was 0.71. Conclusion A 24-hour recall period for PRO-CTCAE items has acceptable measurement properties and can inform day-to-day variations in symptomatic AEs when daily PRO-CTCAE administration is implemented in a clinical trial.

Purpose Missing scores complicate analysis of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) because patients with and without missing scores may systematically differ. We focus on optimal analysis methods for incomplete PRO-CTCAE items, with application to two randomized, double-blind, placebo-controlled, phase III trials. Methods In Alliance A091105 and COMET-2, patients completed PRO-CTCAE items before randomization and several times post-randomization (N = 64 and 107, respectively). For each trial, we conducted between-arm comparisons on the PRO-CTCAE via complete-case two-sample t-tests, mixed modeling with contrast, and multiple imputation followed by two-sample t-tests. Because interest lies in whether CTCAE grades can inform missing PRO-CTCAE scores, we performed multiple imputation with and without CTCAE grades as auxiliary variables to assess the added benefit of including them in the imputation model relative to only including PRO-CTCAE scores across all cycles. Results PRO-CTCAE completion rates ranged from 100.0 to 71.4% and 100.0 to 77.1% across time in A091105 and COMET-2, respectively. In both trials, mixed modeling and multiple imputation provided the most similar estimates of the average treatment effects. Including CTCAE grades in the imputation model did not consistently narrow confidence intervals of the average treatment effects because correlations for the same PRO-CTCAE item between different cycles were generally stronger than correlations between each PRO-CTCAE item and its corresponding CTCAE grade at the same cycle. Conclusion For between-arm comparisons, mixed modeling and multiple imputation are informative techniques for handling missing PRO-CTCAE scores. CTCAE grades do not provide added benefit for informing missing PRO-CTCAE scores. ClinicalTrials.gov Identifiers: NCT02066181 (Alliance A091105); NCT01522443 (COMET-2).

Introduction Alliance for Clinical Trials in Oncology (Alliance) coordinated trials utilize Medidata Rave® (Rave) as the primary clinical data capture system. A growing number of innovative and complex cancer care delivery research (CCDR) trials are being conducted within the Alliance with the aims of studying and improving cancer-related care. Because these trials encompass patients, providers, practices, and their interactions, a defining characteristic of CCDR trials is multilevel data collection in pragmatic settings. Consequently, CCDR trials necessitated innovative strategies for database development, centralized data management, and data monitoring in the presence of these real-world multilevel relationships. Having real trial experience in working with community and academic centers, and having recently implemented five CCDR trials in Rave, we are committed to sharing our strategies and lessons learned in implementing such pragmatic trials in oncology. Methods Five Alliance CCDR trials are used to describe our approach to analyzing the database development needs and the novel strategies applied to overcome the unanticipated challenges we encountered. The strategies applied are organized into 3 categories: multilevel (clinic, clinic stakeholder, patient) enrollment, multilevel quantitative and qualitative data capture, including nontraditional data capture mechanisms being applied, and multilevel data monitoring. Results A notable lesson learned in each category was (1) to seek long-term solutions when developing the functionality to push patient and non-patient enrollments to their respective Rave study database that affords flexibility if new participant types are later added; (2) to be open to different data collection modalities, particularly if such modalities remove barriers to participation, recognizing that additional resources are needed to develop the infrastructure to exchange data between that modality and Rave; and (3) to facilitate multilevel data monitoring, orient site coordinators to the their trial’s multiple study databases, each corresponding to a level in the hierarchy, and remind them to establish the link between patient and non-patient participants in the site-facing NCI web-based enrollment system. Conclusion Although the challenges due to multilevel data collection in pragmatic settings were surmountable, our shared experience can inform and foster collaborations to collectively build on our past successes and improve on our past failures to address the gaps.

Expectancy Value Theory (EVT) is a prominent theory on student motivation. To add to the growing research in this area, we investigated students within a large, mandatory course outside of the STEM areas, to examine perceptions of success utilizing an EVT lens. The aim of our study was twofold. First, to examine students' open-ended responses about what makes them feel successful. Second, to determine if students’ indorsement of expectancy, value, and control could predict their feelings of success. The study consisted of 210 students who completed an online questionnaire with items related to demographics, EVT components, and questions about their success in the course. Deductive coding was utilized to examine their feelings of success based on the EVT components. Regression analysis was utilized to predict perceptions of success. Students identified several components of their course that were associated with expectancy, value, and cost. Students' perceptions of success were positively predicted by expectancy and negatively predicted by cost while value was not a significant predictor. Our results speak to the importance of expectancy, value, and cost when designing large, mandatory courses. We provided several recommendations for instructors when designing courses, and also highlight limitations and future research directions.

Background The study tests the effects of data collection modes on patient responses associated with the multi-item measures such as Patient-Reported Outcomes Measurement System (PROMIS®), and single-item measures such as Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), and Numerical Rating Scale (NRS) measures. Methods Adult cancer patients were recruited from five cancer centers and administered measures of anxiety, depression, fatigue, sleep disturbance, pain intensity, pain interference, ability to participate in social roles and activities, global mental and physical health, and physical function. Patients were randomized to complete the measures on paper (595), interactive voice response (IVR, 596) system, or tablet computer (589). We evaluated differential item functioning (DIF) by method of data collection using the R software package, lordif. For constructs that showed no DIF, we concluded equivalence across modes if the equivalence margin, defined as ± 0.20 × pooled SD, completely surrounds 95% confidence intervals (CI's) for difference in mean score. If the 95% CI fell totally outside the equivalence margin, we concluded systematic score difference by modes. If the 95% CI partly overlaps the equivalence margin, we concluded neither equivalence nor difference. Results For all constructs, no DIF of any kind was found for the three modes. The scores on paper and tablet were more comparable than between IVR and other modes but none of the 95% CI’s were completely outside the equivalence margins, in which we established neither equivalence nor difference. Percentages of missing values were comparable for paper and tablet modes. Percentages of missing values were higher for IVR (2.3% to 6.5% depending on measures) compared to paper and tablet modes (0.7% to 3.3% depending on measures and modes), which was attributed to random technical difficulties experienced in some centers. Conclusion Across all mode comparisons, there were some measures with CI’s not completely contained within the margin of small effect. Two visual modes agreed more than visual-auditory pairs. IVR may induce differences in scores unrelated to constructs being measured in comparison with paper and tablet. The users of the surveys should consider using IVR only when paper and computer administration is not feasible.

Immer noch wird „Digitalisierung“ wie eine unangenehme Anpassung an die jeweils neue Lage empfunden. Die fast erzwungenen Masnahmen wirken wie eine neue Oberflache, unter der eigentlich alles bei Alten bleibt. Echten Problemen wird ausgewichen, man versucht es mit Workaround. Statt einer digitalen Neuerfindung migriert man auf neuere Technologien, immer wieder – was nur Geld kostet, aber im Sinne des Business nichts bringt. Es geht kein Ruck durch die IT und schon gar nicht durch die Vorstandsetagen. Viele Unternehmen zucken nur nch mit den Achseln, wenn Kunden eine moderne IT anmahnen. Eine solche Haltung konnte man „Einigeln“ nennen – das ist die Unternehmensphase vor dem Tod. Was muss geschehen? Ausigeln, ganz klar.

Essential thrombocythemia (ET) and polycythemia vera (PV) are myeloproliferative neoplasms (MPNs) characterized by an increased risk of developing venous and arterial thromboses and of evolution to myelofibrosis or acute leukemia (1). MPNs are recognized as a major cause of splanchnic vein thromboses (SVT), which include hepatic, splenic, portal and mesenteric vein thromboses (2). Patients with SVT are at an increased risk of developing bleeding events and arterial thrombotic events (3), as well as recurrent SVT and the use of anticoagulation and cytoreduction do not clearly modify this risk (3–5). Management of SVT in MPN patients remains a challenge and most therapeutic recommendations are based on retrospective analyses (6). Recently, De Stefano reported that hydroxyurea failed to prevent recurrent thromboses in the splanchnic vasculature in patients with a prior SVT (7). We conducted a prospective, open-label, multi-center phase II clinical trial of Pegylated Interferon Alfa-2a (PEG) in 20 subjects with SVT and an MPN, who represented a cohort of patients who participated in the Myeloproliferative Disorders - Research Consortium (MPD-RC) 111 trial (). MPD-RC 111 was a prospective study of patients with high-risk ET/PV who were resistant or intolerant to hydroxyurea (HU), but prior HU therapy was not a requirement for patients to enter the SVT cohort. Here we report the outcomes of the 20 SVT patients who were treated with PEG.

Tobacco use presents a tremendous burden on population health and remains the leading preventable cause of morbidity and mortality worldwide. Building on tobacco control successes to date, public health agencies are increasingly aligning with the international “Tobacco Endgame” initiative targeting decreases in tobacco use to less than 5% by the year 2025. The local implementation of this initiative follows a decade of work at Region of Peel-Public Health (RoP-PH), a local health department in Ontario, Canada, which made “Living Tobacco-Free” (LTF) a strategic priority in 2009 with a tactical framework encompassing Research, Protection, Prevention, and Cessation. This commentary provides an overview of the results observed by this local health department’s decision to make LTF a strategic priority and discusses the department’s next steps in developing a Theory of Change to systematically align continuing efforts to the call for a “Tobacco Endgame”.

Microsatellitosis (mS) in melanoma has been considered a marker of unfavorable tumor biology, leading to the current American Joint Committee on Cancer staging of IIIB/C/D disease, despite few investigative studies of this entity limited by the small sample sizes and incomplete nodal microstaging. We sought to better characterize outcomes and prognostic factors in a multi-institutional cohort of patients with mS and nodal microstaging. The Sentinel Lymph Node Working Group cohort included 414 mS patients who underwent sentinel lymph node (SLN) biopsy. Cox regression analysis was used to evaluate the prognostic significance of established clinicopathologic characteristics. Melanoma-specific survival (MSS) of patients with mS was compared with 3002 similarly staged patients from the Surveillance, Epidemiology, and End Results (SEER) Program registry. The median age of the mS cohort was 64.9 years; 39.6% were female. Median thickness was 3 mm, 40.6% of cases were ulcerated, and the SLN positivity rate was 46.7%. Increasing thickness, male sex, and SLN positivity were significantly associated with poorer MSS. Stage IIIB/C/D 5-year MSS rates were 86.3% (95% confidence interval [CI] 79.4–93.3%), 54.1% (95% CI 45.4–59.7%), and 44.2% (95% CI 25.4–63.0%), respectively. MSS survival for the stage IIIB mS cohort was significantly better than a similarly staged SEER cohort (5-year MSS of 70.1%, 95% CI 66.0–74.2%), while no significant difference was observed for the stage IIIC or D cohorts. SLN metastases are common and are a significant prognostic factor in patients with mS. Survival in stage IIIB patients with mS was considerably more favorable than their stage would otherwise suggest, which has important implications for decisions regarding adjuvant therapy for patients with mS.

SETTING: During a period of regulatory uncertainty, a local public health unit in Ontario was notified of an exhibition for electronic nicotine delivery systems (ENDS) and novel tobacco delivery products (NTDs), specifically e-cigarettes and waterpipes, which have seen increasing use particularly among youth. Relevant statutes creating regulatory uncertainty included a new provincial Electronic Cigarettes Act (ECA) with certain sections awaiting proclamation, and a local waterpipe bylaw awaiting approval, which would have prohibited the use of these products in public spaces if they entered into force ahead of the exhibition date. Public health staff had concerns the event would normalize use of ENDS/NTDs, particularly among youth, and also planned to enforce already proclaimed ECA sections, as well as the existing Smoke-Free Ontario Act (SFOA) with regulations applicable to use of tobacco shisha in waterpipes. INTERVENTION: Public health staff contacted event organizers and proprietors to communicate obligations under the SFOA and ECA, as well as share hypothetical implications from pending regulatory changes, including risk of charges for regulatory non-compliance if regulations came into force ahead of the planned event. OUTCOMES: Following discussion with health unit staff and legal consultation, the exhibition was cancelled. IMPLICATIONS: By directly communicating regulatory uncertainty, a public health unit was able to achieve local health goals. In this situation, public health advised exhibition proprietors of potential event disruption implicated by forthcoming regulatory changes. Subsequent cancellation of the event prevented potential adverse health impacts for at-risk groups. A similar communications approach could be used to achieve public health goals during a period of regulatory uncertainty.

Over the past century, the dominant model for addressing mental illness has been the treatment of individuals, largely by individual therapists who assume the availability of individual psychological resources. That form of therapy is a scarce commodity in capitalist societies, and social models of healing have been largely marginalized and forgotten. From the point of view of an indigenous psychology of religion, this essay (1) reports on local cultural and community models of healing that honor the common good, draw on local, communal narratives, and involve a given community in the process of healing. However, because it is not simply community in itself that is therapeutic, the authors argue (2) that healing cultures have communities that are guided by their moral vision and are committed to justice, moral integrity, and the sharing of resources. They draw on intergenerational studies that detail the effects in Inuit communities where a moral vision and a sense of community was present but then was eroded. Therapists whose interventions draw on the moral resources of the community may facilitate healing, as demonstrated by the use of allocentric imaging in more communal traditions. Finally, it is not simply communities with moral ideals that are therapeutic but (3) indigenous communities whose structures and whose role models embody their ethic that is critical for healing. The authors examine ecological communities in China committed to Confucian values and protection of the earth. The L’Arche communities begun in France by Jean Vanier and Alcoholics Anonymous groups around the world serve as examples of embodied moral communities.

Alle zwei Jahre schreibe ich eine Kolumne „zum Buch“. Dies erscheint gerade unter dem Titel Flachsinn – Ich habe Hirn, ich will hier raus. Es geht darin um viele Themen rund um die Aufmerksamkeit, die heute so wichtig geworden ist. Aufmerksamkeit wird derzeit schon als neue Wahrung „des Jahrhunderts“ angesehen. Na, jedenfalls hat sie einen eigenen hohen Stellenwert gewonnen.

A cancer diagnosis requires significant information to facilitate health care decision making, understand management options, and health care system navigation. Patient knowledge deficit can decrease quality of life and health care compliance. Surveys were distributed to attendees of the Mayo Clinic "Living with and Surviving Cancer" patient symposium January 2015. Follow-up survey was sent to participants 3 months after the symposium. Surveys included demographic data and patient-reported disease comprehension, symptom burden, desired information, and quality-of-life assessment. Demographics: 113 patients completed the pre-intervention survey. Average age was 64.7 years. Disease types included hematologic (N = 50) and solid malignancies (N = 77). Most patients self-reported adequate baseline understanding of their disease (80 %), screening tests (74 %), and monitoring tools (72 %). Lowest knowledge topics were legal issues (13 %) and pain management (35 %). Pre- and post-analysis: 79 of the initial 113 participants completed both surveys. In the post-symposium setting, durable knowledge impact was noted in disease understanding (pre 80 % vs post 92 %), treatment options (pre 60 % vs post 76 %), nutrition (pre 68 % vs post 84 %), and legal issues (pre 15 % vs post 32 %). Most patients desired increased understanding regarding disease, screening tests, nutrition, and stress and fatigue management. The level of desired information for these topics decreased in the post-symposium setting, statistically significant decrease noted in 4 of 5 topics assessed. Knowledge needs and deficit in cancer care range from disease-specific topics, social stressors, and health care navigation. A cancer patient-centered symposium can improve patient-reported knowledge deficit, with durable responses at 3 months, but patient needs persist.

Umdenken! Neumachen! Radikal verandern! Das horen wir jeden Tag. Es passiert aber wenig; das argert eigentlich alle; sie brechen deswegen aber nicht auf – aus verschiedenen Grunden. Ich will heute daruber philosophieren, dass sich die verschiedenen Denkweisen in Management und Engineering nicht so gerne in Abenteuer begeben wollen. Keiner will so recht, aber sie fauchen uber alle, die mutig vorangehen und ihnen am Ende das Geschaft wegnehmen, mindestens aber die Butter vom Brot. Wenn heute Industrie 4.0 angesagt ist, wenn also IT und Engineering zusammen einen neuen Weg gehen wollen und bald eben mussen – wie geht das aus?

This essay is an extended reflection on Belzen’s (2010) groundbreaking book Towards Cultural Psychology of Religion: Principles, Approaches, Applications. We will critically examine the terms culture, psychology, and religion separately and in relation to each other. The question we address is whether unconsciously Western understandings underlie these concepts and then are exported into non-Western cultures. The concept of ‘culture’ may reflect a Western bias and may be injurious when exported if culture means de facto becoming self-consciously modern, remains an abstract idea, reinforces “othering,” and serves to colonize the other. It is proposed that we listen to voices of non-Western scholars as they reflect on what ‘culture’ means to them rather than assuming that the meaning of the word ‘culture’ is universally the same. Second, we examine briefly the ways in which our understanding of religion reflects our Western biases in terms of the presumption of secularization, the meaning of religiousness, the Christian influence on defining religion, the use of religion in Western colonization, and the degree to which religion is defined abstractly. Third, we are concerned that the psychology utilized in the emerging discipline of psychology of religion is Western in that it reflects a capitalist, industrialized, individualistic, and pluralistic culture that may be less present in other cultures and perhaps even eschewed. Further, we think that in various cultures of the world, psychological knowledge emerges less from scientific observation but from the local religious/cultural traditions themselves. Finally, we examine how cultural psychology intersects with religion. We propose a model in which the specific religious cultures nurture the attitudes, emotions, behaviors, and relationships that reflect their critical values.