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OBJECTIVE: To identify the perspectives of patients with rheumatoid arthritis (RA) on electronic recording of between-visit disease activity and other patient-reported outcomes (PROs), and sharing this information with health care providers or peers. METHODS: Patients with RA were recruited to participate in focus groups from December 2014 to April 2015. The topic guide and analysis were based on Andersen and Newman’s framework. Sessions were audio recorded, transcribed, independently coded, and analyzed for themes. RESULTS: Thirty-one patients participated in seven focus groups. Their mean age was 51 (SD 13.1); 94% were female, 52% were African Americans, 11% were Hispanics, and 37% were Caucasians. Three themes emerged: 1) provider communication, 2) information seeking about RA, and 3) social and peer support. Participants expressed willingness to track disease activity data to share with health care providers electronically if providers would act on the information. Participants envisioned symptom tracking and information sharing as a mechanism to relay and obtain reliable information about RA. Participants were also interested in electronic communication between visits if it facilitated learning about symptom management and enhanced opportunities for social support among persons with RA. CONCLUSION: Patients with RA may be amenable to electronic collection and sharing of PRO-type data between clinical encounters if it facilitates communication with health care providers, and provides access to reliable information about RA. Providing patients with social support was important for enhancing PROs collection by helping them overcome barriers with using electronic devices and patients’ reservations about the value of this data.

Purpose: Preclinical data indicate that DNA methyltransferase inhibition will circumvent cisplatin resistance in various cancers. Patient and Methods: SPIRE comprised a dose-escalation phase for incurable metastatic solid cancers, followed by a randomized dose expansion phase for neoadjuvant treatment of T2–4a N0 M0 bladder urothelial carcinoma. The primary objective was a recommended phase II dose (RP2D) for guadecitabine combined with gemcitabine and cisplatin. Treatment comprised 21-day gemcitabine and cisplatin cycles (cisplatin 70 mg/m2, i.v., day 8 and gemcitabine 1,000 mg/m2, i.v., days 8 + 15). Guadecitabine was injected subcutaneously on days 1–5, within escalation phase cohorts, and to half of 20 patients in the expansion phase. Registration ID: ISRCTN 16332228. Results: Within the escalation phase, dose-limiting toxicities related predominantly to myelosuppression requiring G-CSF prophylaxis from cohort 2 (guadecitabine 20 mg/m2, days 1–5). The most common grade ≥3 adverse events in 17 patients in the dose-escalation phase were neutropenia (76.5%), thrombocytopenia (64.7%), leukopenia (29.4%), and anemia (29.4%). Addition of guadecitabine to gemcitabine and cisplatin in the expansion phase resulted in similar rates of severe hematologic adverse events, similar cisplatin dose intensity, but modestly reduced gemcitabine dose intensity. Radical treatment options after chemotherapy were not compromised. Pharmacodynamics evaluations indicated guadecitabine maximal target effect at the point of cisplatin administration. Pharmacokinetics were consistent with prior data. No treatment-related deaths occurred. Conclusions: The guadecitabine RP2D was 20 mg/m2, days 1–5, in combination with gemcitabine and cisplatin and required GCSF prophylaxis. Gene promoter methylation pharmacodynamics are optimal with this schedule. Addition of guadecitabine to gemcitabine and cisplatin was tolerable, despite some additional myelosuppression, and warrants further investigation to assess efficacy.

Resilience may help people living with HIV (PLWH) overcome adversities to disease management. This study identifies multilevel resilience resources among African American/Black (AA/B) PLWH and examines whether resilience resources differ by demographics and neighborhood risk environments. We recruited participants and conducted concept mapping at two clinics in the southeastern United States. Concept Mapping incorporates qualitative and quantitative methods to represent participant-generated concepts via two-dimensional maps. Eligible participants had to attend ≥75% of their scheduled clinic appointments and did not have ≥2 consecutive detectable HIV-1 viral load measurements in the past two years. Of the 85 AA/B PLWH who were invited, forty-eight participated. Twelve resilience resource clusters emerged - five individual, two interpersonal, two organizational/policy and three neighborhood level clusters. There were strong correlations in cluster ratings for demographic and neighborhood risk environment comparison groups (r ≥ 0.89). These findings could inform development of theories, measures and interventions for AA/B PLWH.

Background Patients with inflammatory arthritis (IA), defined as rheumatoid arthritis (RA) and psoriatic arthritis (PsA), are at increased risk for cardiovascular disease (CVD). The frequency of screening and treatment of hyperlipidemia, a modifiable CVD risk factor, is low in these patients. The reasons for low screening and treatment rates in this population are poorly understood. Our objective was to elicit the barriers and facilitators for screening and treatment of hyperlipidemia from the perspective of patients with IA. Methods We conducted a qualitative study using focus groups of patients with IA, guided by Bandura’s Social Cognitive Theory. We recruited patients with IA aged 40 years and older from a single academic center. Data were analyzed thematically. Results We conducted three focus groups with 17 participants whose mean age was 56 (range 45–81) years; 15 were women. Four themes emerged as barriers: 1) need for more information about arthritis, prognosis, and IA medications prior to discussing additional topics like CVD risk; 2) lack of knowledge about how IA increases CVD risk; 3) lifestyle changes to reduce overall CVD risk rather than medications; and 4) the need to improve doctor-patient communication about IA, medications, and CVD risk. One theme emerged as a facilitator: 5) potential for peer coaches (patients with IA who are trained about concepts of CVD risk and IA) to help overcome barriers to screening and treatment of hyperlipidemia to lower CVD risk. Conclusion Patients with IA identified educational needs about IA, increased CVD risk in IA and the need for improved doctor-patient communication about screening for hyperlipidemia and its treatment. Patients were receptive to working with peer coaches to facilitate achievement of these goals.

Background Patient-reported outcomes (PROs) aid in rheumatoid arthritis (RA) management, but it is not well understood which measures would be most relevant to the rheumatologists for making treatment decisions. Methods We recruited rheumatologists nationally to participate in moderated structured group teleconference discussions using the nominal group technique. Participants in each group generated lists of the elements from patient’s history and signs that they use to make treatment recommendations for RA. Each participant then selected the three most important elements from the generated list. The results of each group were then combined and summarized. Results Twenty-five rheumatologists participated in 4 groups (group size ranged from 4 to 8) and 150 available ranking votes across all groups. The statements generated across the 4 groups were categorized into 13 topics (including symptoms, physical function, comorbidities, social aspects, physical findings, response to treatment, treatment adherence, pain management, side effects, tests, access to care, contraception, and organ involvement), 10 of which received ranking votes. Symptoms received the highest ranking (46% of votes), followed by physical function (16%), and physical findings (13%). Among the unranked topics, social aspects had the highest number of statements (8 statements). Conclusion Rheumatologists highly valued patient-reported RA symptoms and physical function to inform their treatment decisions, even above objective data such as physical findings and test results. These results can guide the selection of validated PRO measures to assess these domains to inform the clinical care of patients with rheumatoid arthritis. Electronic supplementary material The online version of this article (10.1186/s41927-019-0087-2) contains supplementary material, which is available to authorized users.

PURPOSE: To investigate the role of patient-specific dosimetry as a predictive marker of survival and as a potential tool for individualised molecular radiotherapy treatment planning of bone metastases from castration-resistant prostate cancer, and to assess whether higher administered levels of activity are associated with a survival benefit.METHODS: Clinical data from 57 patients who received 2.5-5.1 GBq of (186)Re-HEDP as part of NIH-funded phase I/II clinical trials were analysed. Whole-body and SPECT-based absorbed doses to the whole body and bone lesions were calculated for 22 patients receiving 5 GBq. The patient mean absorbed dose was defined as the mean of all bone lesion-absorbed doses in any given patient. Kaplan-Meier curves, log-rank tests, Cox's proportional hazards model and Pearson's correlation coefficients were used for overall survival (OS) and correlation analyses.RESULTS: A statistically significantly longer OS was associated with administered activities above 3.5 GBq in the 57 patients (20.1 vs 7.1 months, hazard ratio: 0.39, 95 % CI: 0.10-0.58, P = 0.002). A total of 379 bone lesions were identified in 22 patients. The mean of the patient mean absorbed dose was 19 (±6) Gy and the mean of the whole-body absorbed dose was 0.33 (±0.11) Gy for the 22 patients. The patient mean absorbed dose (r = 0.65, P = 0.001) and the whole-body absorbed dose (r = 0.63, P = 0.002) showed a positive correlation with disease volume. Significant differences in OS were observed for the univariate group analyses according to disease volume as measured from SPECT imaging of (186)Re-HEDP (P = 0.03) and patient mean absorbed dose (P = 0.01), whilst only the disease volume remained significant in a multivariable analysis (P = 0.004).CONCLUSION: This study demonstrated that higher administered activities led to prolonged survival and that for a fixed administered activity, the whole-body and patient mean absorbed doses correlated with the extent of disease, which, in turn, correlated with survival. This study shows the importance of patient stratification to establish absorbed dose-response correlations and indicates the potential to individualise treatment of bone metastases with radiopharmaceuticals according to patient-specific imaging and dosimetry.

This study was supported by Cancer Research UK, AstraZeneca and Pfizer UK. Introduction: Phase I of the Cancer Research UK Stratified Medicine Programme (SMP1) was designed to roll out molecular pathology testing nationwide at the point of cancer diagnosis, as well as facilitate an infrastructure where surplus cancer tissue could be used for research. It offered a non-trial setting to examine common UK cancer genetics in a real-world context. Methods: A total of 26 sites in England, Wales and Scotland, recruited samples from 7814 patients for genetic examination between 2011 and 2013. Tumour types involved were breast, colorectal, lung, prostate, ovarian cancer and malignant melanoma. Centralised molecular testing of surplus material from resections or biopsies of primary/metastatic tissue was performed, with samples examined for 3-5 genetic alterations deemed to be of key interest in site-specific cancers by the National Cancer Research Institute Clinical Study groups. Results: 10 754 patients (98% of those approached) consented to participate, from which 7814 tumour samples were genetically analysed. In total, 53% had at least one genetic aberration detected. From 1885 patients with lung cancer, KRAS mutation was noted to be highly prevalent in adenocarcinoma (37%). In breast cancer (1873 patients), there was a striking contrast in TP53 mutation incidence between patients with ductal cancer (27.3%) and lobular cancer (3.4%). Vast inter-tumour heterogeneity of colorectal cancer (1550 patients) was observed, including myriad double and triple combinations of genetic aberrations. Significant losses of important clinical information included smoking status in lung cancer and loss of distinction between low-grade and high-grade serous ovarian cancers. Conclusion: Nationwide molecular pathology testing in a non-trial setting is feasible. The experience with SMP1 has been used to inform ongoing CRUK flagship programmes such as the CRUK National Lung MATRIX trial and TRACERx. Publisher PDF

OBJECTIVE:The aim of this study was to calculate the range of absorbed doses that could potentially be delivered by a variety of radiopharmaceuticals and typical fixed administered activities used for bone pain palliation in a cohort of patients with metastatic castration-resistant prostate cancer (mCRPC). The methodology for the extrapolation of the biodistribution, pharmacokinetics and absorbed doses from a given to an alternative radiopharmaceutical is presented.METHODS:Sequential single photon emission CT images from 22 patients treated with 5 GBq of 186Re-HEDP were used to extrapolate the time–activity curves for various radiopharmaceuticals. Cumulated activity distributions for the delivered and extrapolated treatment plans were converted into absorbed dose distributions using the convolution dosimetry method. The lesion absorbed doses obtained for the different treatments were compared using the patient population distributions and cumulative dose–volume histograms.RESULTS:The median lesion absorbed doses across the patient cohort ranged from 2.7 Gy (range: 0.6–11.8 Gy) for 1100 MBq of 166Ho-DOTMP to 21.8 Gy (range: 4.5–117.6 Gy) for 150 MBq of 89Sr-dichloride. 32P-Na3PO4, 153Sm-EDTMP, 166Ho-DOTMP, 177Lu-EDTMP and 188Re-HEDP would have delivered 41, 32, 85, 20 and 64% lower absorbed doses, for the typical administered activities as compared to 186Re-HEDP, respectively, whilst 89Sr-dichloride would have delivered 25% higher absorbed doses.CONCLUSION:For the patient cohort studied, a wide range of absorbed doses would have been delivered for typical administration protocols in mCRPC. The methodology presented has potential use for emerging theragnostic agents.ADVANCES IN KNOWLEDGE:The same patient cohort can receive a range of lesion absorbed doses from typical molecular radiotherapy treatments for patients with metastatic prostate cancer, highlighting the need to establish absorbed dose response relationships and to treat patients according to absorbed dose instead of using fixed administered activities.

Background Data capture of patient reported outcomes (PROs) is gradually shifting from data collection on paper in medical office settings to use of computer or mobile based technologies between doctor visits. Concerns have been raised that patients may have limited interest in contributing data over time or that they may only record new data when there has been a change in their clinical status. Objectives The objective of this study was to evaluate the patterns and factors associated with longitudinal PRO data capture among participants in the PCORI-funded Patient Powered Research Network for adult rheumatologic conditions, ArthritisPower. Methods Patients in the registry were asked to voluntarily complete PROs including the RAPID3 and 4 PROMIS instruments plus disease-specific information via a mobile application (App) on their smartphone or computer. We evaluated the average time it took the patient to record each of the instruments and the total number of unique days that patients recorded PROs on the smartphone. Given the newness of the registry (launched late 2015), longitudinal data was defined as contributing at least 2 sets of PROs on unique calendar days. We tested the hypothesis that patients would contribute longitudinal data only when at least one of their scores exceeded a minimally important difference (MID) of any of the 5 PROs examined (generally 2–3 units for PROMIS instruments; 3.6 units for RAPID3). Demographic factors associated with multiple PRO reports were identified using logistic regression among patients who had been enrolled in the registry for at least 3 months. Results At the time of analysis, ArthritisPower had recruited 2,103 patients, most (approximately 68%) had RA, and 20% provided their Twitter handle. Average (SD) age was 50 (12); 87% were women. The mean assessment time for each of the PROMIS instruments ranged from a low of 16 seconds (Sleep Disturbance) to a high of 105 seconds (RAPID3). The average score for Pain Interference was 64.3 (SD: 6.3), Physical Function 37.5 (6.5), Sleep Disturbance 59.3 (8.4), Fatigue 64.2 (8.4), and RAPID3 15.7 (5.3). Of 1,946 patients who registered the Smartphone App more than 3 months prior to analysis, 20.6% never contributed any PRO information, 53.3% answered once, and 26.1% answered at least twice. Among patients with longitudinal data (≥2 assessments), the mean change score of PROs between pairwise PRO assessments was Conclusions Multiple factors were associated with patients contributing longitudinal PRO data. Patients were willing to contribute longitudinal PRO data even in the absence of a change in their health state exceeding any MID. Additional efforts are needed to engage patients to contribute PRO data over time. Disclosure of Interest None declared

Background: The neutrophil to lymphocyte ratio (NLR) has been shown to be highly prognostic across many tumor types, and predictive of treatment outcome in advanced prostate cancer, and has been postulated to be an indirect measure of tumor inflammation. We evaluated the effect of low-dose steroids on NLR in men suffering from castrationresistant prostate cancer (CRPC). Patients and Methods: The NLR was evaluated in a prospective randomized phase II trial that compared prednisolone 5 mg twice daily and dexamethasone 0.5 mg daily administered to 75 chemotherapy and abiraterone/enzalutamide-naive CRPC patients. NLR was examined at baseline (BL), after 6 and 12 weeks of corticosteroid treatment; associations with > 50% prostate-specific antigen (PSA) response, duration of response (PSA progression-free interval), and overall survival (OS) were tested using logistic regression and Cox regression analysis. Results: The median NLR for all evaluable patients was 2.6 at BL; 2.9 at 6 weeks; and 4.0 at 12 weeks. After low-dose corticosteroid initiation, 46 patients had a decline in PSA with 24 confirmed responders. BL NLR (log10) associated with a PSA response (odds ratio,.029, 95% confidence interval [CI],.002-. 493; P = .014), and with the extent of the PSA decline (P = .009). A favorable BL NLR (less than median) associated with a 5.5-fold higher odds of a PSA > 50% response (95% CI, 1.3-23.9; P = .02). Higher BL NLR (log10) associated with a shorter time to PSA progression (hazard ratio [HR], 9.5; 95% CI, 2.3-39.9; P = .002). In multivariate analysis BL NLR as a discrete variable was independently associated with PSA progression (HR, 3.5; 95% CI, 1.5-8.1; P = .003). NLR at 6 weeks was also associated with duration of benefit; in the favorable NLR category time to PSA progression was 10.8 months, for those who converted to an unfavorable (greater than median) category 4.5 months, and for those remaining in a unfavorable category only 1.5 months (95% CI, 0.5-2.5; P = .003). OS was 33.1 months (95% CI, 24.2-42.0) and 21.9 months (95% CI, 19.3-24.4) for those with an favorable and unfavorable BL NLR, respectively. Conclusion: Treatment-naive CRPC patients with a high BL or during-treatment NLR appear not to benefit from low-dose corticosteroids. The immunological implications of an unfavorable NLR, and whether corticosteroids might drive prostate cancer progression in patients harboring a high NLR, warrant further study. (C) 2017 Elsevier Inc. All rights reserved.

Independence in activities of daily living, self-advocacy and peer support are important aspects of adolescent development. These skills are potentially affected by chronic rheumatic diseases and are worthy of attention by occupational therapists and other members of the multidisciplinary team. An innovative 4-day residential programme for young people diagnosed with chronic rheumatic disease, known as the ‘Independence Break’, was evaluated in order to determine its perceived benefits. The participants were invited to complete a brief evaluation form immediately after the trip to determine the benefits of participation in the programme. The levels of continuing social contact within the group were established 4 months later during a subsequent telephone call. Thirty young people (median age 14 years) attended the 4-day programme and reported friendship and improved performance in activities of daily living as the major benefits. The majority stayed in touch with at least one other person, with more girls staying in touch than boys. The preferred method of communication was text messaging. Overall, the programme was perceived to be a valuable experience and offered the young people an opportunity to develop informal peer support networks. The potential of text messaging within adolescent rheumatology is also highlighted.

Background While healthcare provider priorities often coalesce around clinical concerns, little has been done to explore the most pressing educational concerns among rheumatic disease patients. Objectives To identify healthcare education topics most important to patients with inflammatory arthritis and other rheumatic conditions. Methods Participants were recruited from within the membership registry of the rheumatology patient community, CreakyJoints, to participate in one of six nominal groups held in June 2015. Each of the six groups generated a set of educational topics or questions (“items”), and then rank-ordered them within each focus group. Items were aggregated into common topic groups, redundant items de-duplicated, and then categorized into common topic groups and themes. Based on the qualitative work, a survey describing items from all nominal groups was created and deployed more widely to the CreakyJoints membership. Demographics and other disease-related features were captured. Results From the nominal groups, 8 educational themes emerged that were related to 28 unique educational topics (see Table 1). Overall, “Lifestyle changes and patient environment modifications” was the most valued theme, receiving 14% of votes. Medication data (drug dosing, interactions, performance, etc.), physician selection, and knowledge of disease/disease progression were also strongly emphasized at 12%, 11%, and 10%, respectively. Themes of least interest included friend/family/community support, financial concerns (including insurance), and social interactions, with nominal group vote percentages of 3%, 2%, and 1%, respectively. Among 400 participants who completed the survey, mean (SD) age was 55 (11.5) years with 86% being women and 82% being white. Participant health conditions (not mutually exclusive) included rheumatoid arthritis (74%), osteoarthritis (45%), fibromyalgia (26%), osteoporosis (18%), psoriatic arthritis (8%), lupus (5%), and ankylosing spondylitis (5%). The top 10 items rated as “Extremely Important” by a majority of patients were: How arthritis affects more than just your joints (86%); What are the signs that the medication is not working (84%); Importance of knowing about how the disease will progress, even if the news is bad (83%); What are the side effects of available drugs, and how do the drugs interact with each other (82%); What are the available medications and treatments for your case (80%); How to understand the results of tests used to monitor your condition (79%); How to find the right rheumatologist (76%); How to take an active role in decisions about your care (76%); How your life will change as your disease progresses (74%); and How to speak up and help manage your care when your perspective is different from your doctor9s (73%). Conclusions Patients with rheumatic diseases are concerned about a variety of topics, which include lifestyle changes/patient environment modifications, medication data, and physician choice. Patient-centered research should maximally respond to addressing questions of importance to patients, and this survey is a first step in identifying and prioritizing the topics that matter most to patients. Acknowledgement This work was supported by educational grants from Bristol-Myers Squibb and Pfizer. Disclosure of Interest None declared