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BackgroundMobile health devices are increasingly available, presenting exciting opportunities to remotely collect high-frequency, electronic patient-generated health data (ePGHD). This novel data type may provide detailed insights into disease activity outside usual clinical settings. Assessing treatment responses, which can be hampered by the infrequency of appointments and recall bias, is a promising, novel application of ePGHD. Drugs with short treatment effects, such as intramuscular steroid injections, illustrate the challenge, as patients are unlikely to accurately recall treatment responses at follow-ups, which often occur several months later. Retrospective assessment means that responses may be over- or underestimated. High-frequency ePGHD, such as daily, app-collected, patient-reported symptoms between clinic appointments, may bridge this gap. However, the potential of ePGHD remains untapped due to the absence of established definitions for treatment response using ePGHD or established methodological approaches for analyzing this type of data. ObjectiveThis study aims to explore the feasibility of evaluating treatment responses to intramuscular steroid therapy in a case series of patients with rheumatoid arthritis tracking daily symptoms using a smartphone app. MethodsWe report a case series of patients who collected ePGHD through the REmote Monitoring Of Rheumatoid Arthritis (REMORA) smartphone app for daily remote symptom tracking. Symptoms were tracked on a 0-10 scale. We described the patients’ longitudinal pain scores before and after intramuscular steroid injections. The baseline pain score was calculated as the mean pain score in the 10 days prior to the injection. This was compared to the pain scores in the days following the injection. “Response” was defined as any improvement from the baseline score on the first day following the injection. The response end time was defined as the first date when the pain score exceeded the pre-steroid baseline. ResultsWe included 6 patients who, between them, received 9 steroid injections. Average pre-injection pain scores ranged from 3.3 to 9.3. Using our definitions, 7 injections demonstrated a response. Among the responders, the duration of response ranged from 1 to 54 days (median 9, IQR 7-41), average pain score improvement ranged from 0.1 to 5.3 (median 3.3, IQR 2.2-4.0), and maximum pain score improvement ranged from 0.1 to 7.0 (median 4.3, IQR 1.7 to 6.0). ConclusionsThis case series demonstrates the feasibility of using ePGHD to evaluate treatment response and is an important exploratory step toward developing more robust methodological approaches for analysis of this novel data type. Issues highlighted by our analysis include the importance of accounting for one-off data points, varying response start times, and confounders such as other medications. Future analysis of ePGHD across a larger population is required to address issues highlighted by our analysis and to develop meaningful consensus definitions for treatment response in time-series data.

Morten Høyer1,2, Rune Erichsen1, Per Gandrup3, Mette Nørgaard1, Jacob Bonde Jacobsen11Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark; 2Department of Oncology, Aarhus University Hospital, Aarhus, Denmark; 3Department of Gastrointestinal Surgery, Aarhus University Hospital, Aalborg, DenmarkObjective: In Denmark, the strategy for treatment of cancer with metastases to the liver has changed dramatically during the period 1998 to 2009, when multidisciplinary care and a number of new treatments were introduced. We therefore examined the changes in survival in Danish patients with colorectal carcinoma (CRC) or other solid tumors (non-CRC) who had liver metastases at time of diagnosis.Study design and methods: We included patients diagnosed with liver metastases synchronous with a primary cancer (ie, a solid cancer diagnosed at the same date or within 60 days after liver metastasis diagnosis) during the period 1998 to 2009 identified through the Danish National Registry of Patients. We followed those who survived for more than 60 days in a survival analysis (n = 1021). Survival and mortality rate ratio (MRR) at 1, 3, and 5 years stratified by year of diagnosis were estimated using Cox proportional hazards regression analysis.Results: In the total study population of 1021 patients, 541 patients had a primary CRC and 480 patients non-CRC. Overall, the 5-year survival improved from 3% (95% confidence interval [CI]: 1%–6%) in 1998–2000 to 10% (95% CI: 6%–14%) in 2007 to 2009 (predicted value). The 5-year survival for CRC-patients improved from 1% (95% CI: 0%–5%) to 11% (95% CI: 6%–18%) whereas survival for non-CRC patients only increased from 5% (95% CI: 1%–10%) to 8% (95% CI: 4%–14%).Conclusion: We observed improved survival in patients with liver metastases in a time period characterized by introduction of a structured multidisciplinary care and improved treatment options. The survival gain was most prominent for CRC-patients.Keywords: liver metastases, colorectal cancer, noncolorectal cancer, survival improvement

Eva B Ostenfeld1, Rune Erichsen1, Lene H Iversen1,2, Per Gandrup3, Mette Nørgaard1, Jacob Jacobsen11Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark; 2Department of Surgery P, Aarhus University Hospital, Aarhus, Denmark; 3Department of Surgery A, Aarhus University Hospital, Aalborg, DenmarkObjective: The prognosis for colon and rectal cancer has improved in Denmark over the past decades but is still poor compared with that in our neighboring countries. We conducted this population-based study to monitor recent trends in colon and rectal cancer survival in the central and northern regions of Denmark.Material and methods: Using the Danish National Registry of Patients, we identified 9412 patients with an incident diagnosis of colon cancer and 5685 patients diagnosed with rectal cancer between 1998 and 2009. We determined survival, and used Cox proportional hazard regression analysis to compare mortality over time, adjusting for age and gender. Among surgically treated patients, we computed 30-day mortality and corresponding mortality rate ratios (MRRs).Results: The annual numbers of colon and rectal cancer increased from 1998 through 2009. For colon cancer, 1-year survival improved from 65% to 70%, and 5-year survival improved from 37% to 43%. For rectal cancer, 1-year survival improved from 73% to 78%, and 5-year survival improved from 39% to 47%. Men aged 80+ showed most pronounced improvements. The 1- and 5-year adjusted MRRs decreased: for colon cancer 0.83 (95% confidence interval CI: 0.76–0.92) and 0.84 (95% CI: 0.78–0.90) respectively; for rectal cancer 0.79 (95% CI: 0.68–0.91) and 0.81 (95% CI: 0.73–0.89) respectively. The 30-day postoperative mortality after resection also declined over the study period. Compared with 1998–2000 the 30-day MRRs in 2007–2009 were 0.68 (95% CI: 0.53–0.87) for colon cancer and 0.59 (95% CI: 0.37–0.96) for rectal cancer.Conclusion: The survival after colon and rectal cancer has improved in central and northern Denmark during the 1998–2009 period, as well as the 30-day postoperative mortality.Keywords: neoplasms, survival, epidemiology, colorectal cancer

BackgroundThe ability to predict rheumatoid arthritis (RA) flares between clinic visits based on real-time, longitudinal patient-generated data could potentially allow for timely interventions to avoid disease worsening. ObjectiveThis exploratory study aims to investigate the feasibility of using machine learning methods to classify self-reported RA flares based on a small data set of daily symptom data collected on a smartphone app. MethodsDaily symptoms and weekly flares reported on the Remote Monitoring of Rheumatoid Arthritis (REMORA) smartphone app from 20 patients with RA over 3 months were used. Predictors were several summary features of the daily symptom scores (eg, pain and fatigue) collected in the week leading up to the flare question. We fitted 3 binary classifiers: logistic regression with and without elastic net regularization, a random forest, and naive Bayes. Performance was evaluated according to the area under the curve (AUC) of the receiver operating characteristic curve. For the best-performing model, we considered sensitivity and specificity for different thresholds in order to illustrate different ways in which the predictive model could behave in a clinical setting. ResultsThe data comprised an average of 60.6 daily reports and 10.5 weekly reports per participant. Participants reported a median of 2 (IQR 0.75-4.25) flares each over a median follow-up time of 81 (IQR 79-82) days. AUCs were broadly similar between models, but logistic regression with elastic net regularization had the highest AUC of 0.82. At a cutoff requiring specificity to be 0.80, the corresponding sensitivity to detect flares was 0.60 for this model. The positive predictive value (PPV) in this population was 53%, and the negative predictive value (NPV) was 85%. Given the prevalence of flares, the best PPV achieved meant only around 2 of every 3 positive predictions were correct (PPV 0.65). By prioritizing a higher NPV, the model correctly predicted over 9 in every 10 non-flare weeks, but the accuracy of predicted flares fell to only 1 in 2 being correct (NPV and PPV of 0.92 and 0.51, respectively). ConclusionsPredicting self-reported flares based on daily symptom scorings in the preceding week using machine learning methods was feasible. The observed predictive accuracy might improve as we obtain more data, and these exploratory results need to be validated in an external cohort. In the future, analysis of frequently collected patient-generated data may allow us to predict flares before they unfold, opening opportunities for just-in-time adaptative interventions. Depending on the nature and implication of an intervention, different cutoff values for an intervention decision need to be considered, as well as the level of predictive certainty required.

Background In Ethiopia, childhood pneumonia is diagnosed in primary healthcare settings by measuring respiratory rate (RR) along with the presence of cough, chest indrawing, difficulty breathing, and fast breathing. Our aim was to identify health system-level lessons from implementing two automated RR counters, Children’s Automated Respiration Monitor (ChARM) by Phillips® and Rad-G by Masimo®, to provide considerations for integrating such devices into child health programmes and health systems. This study was part of an initiative called the Acute Respiratory Infection Diagnostic Aids (ARIDA).Methods Key informant interviews (KIIs) were conducted with 57 participants (health workers in communities and facilities, trainers of health workers, district management, and key decision-makers) in five regions of Ethiopia. Data were analyzed in ATLAS.ti using thematic content analysis and themes were categorized using the Tanahashi bottleneck analysis.Results All participants recommended scaling up the ARIDA initiative nationally as part of Integrated Management of Newborn and Childhood Illness (IMNCI) in primary healthcare. Health workers perceived the devices as: time saving, acceptable by parents and children, and facilitating diagnosis and referrals. Health workers perceived an increased demand for services and reduced numbers of sick children not seeking care. Participants recommended increasing the number of devices distributed and health workers trained. Strengthening drug supply chains, improving oxygen gas availability, and strengthening referral networks would maximize perceived benefits. While training improved knowledge, more supportive supervision, integration with current guidelines and more guidance related to community engagement was recommended.Conclusion Automatic RR counters for the decentralized diagnosis of childhood pneumonia could have positive impact on improving the quality of diagnosis and management of pneumonia in children. However, the study has shown that a health system approach is required to ensure all steps along the pneumonia pathway are adequate, including drug and oxygen supply, community engagement, health worker training and support, and referral pathways.

ObjectiveApplying treat-to-target strategies in the care of patients with rheumatoid arthritis (RA) is critical for improving outcomes, yet electronic health records (EHRs) have few features to facilitate this goal. We undertook this study to evaluate the effect of 3 health information technology (health-IT) initiatives on the performance of RA disease activity measures and outcomes in an academic rheumatology clinic.MethodsWe implemented the 3 following initiatives designed to facilitate performance of the Clinical Disease Activity Index (CDAI): an EHR flowsheet to input scores, peer performance reports, and an EHR SmartForm including a CDAI calculator. We performed an interrupted time-series trial to assess effects on the proportion of RA visits with a documented CDAI. Mean CDAI scores before and after the last initiative were compared using t-tests. Additionally, we measured physician satisfaction with the initiatives.ResultsWe included data from 995 patients with 8,040 encounters between 2012 and 2017. Over this period, electronic capture of CDAI scores increased from 0% to 64%. Performance remained stable after peer reporting and the SmartForm were introduced. We observed no meaningful changes in disease activity levels. However, physician satisfaction increased after SmartForm implementation.ConclusionModifications to the EHR, provider culture, and clinical workflows effectively improved capture of RA disease activity scores and physician satisfaction, but parallel gains in disease activity levels were missing. This study illustrates how a series of health-IT initiatives can evolve to enable sustained changes in practice. However, capture of RA outcomes alone may not be sufficient to improve levels of disease activity without a comprehensive treat-to-target program.

Abstract Background Many patients do not fully regain motor function after ischemic stroke. Transcranial direct current stimulation (TDCS) targeting the motor cortex may improve motor outcome as an add-on intervention to physical rehabilitation. However, beneficial effects on motor function vary largely among patients within and across TDCS trials. In addition to a large heterogeneity of study designs, this variability may be caused by the fact that TDCS was given as a one-size-fits-all protocol without accounting for anatomical differences between subjects. The efficacy and consistency of TDCS might be improved by a patient-tailored design that ensures precise targeting of a physiologically relevant area with an appropriate current strength. Methods In a randomized, double-blinded, sham-controlled trial, patients with subacute ischemic stroke and residual upper-extremity paresis will receive two times 20 min of focal TDCS of ipsilesional primary motor hand area (M1-HAND) during supervised rehabilitation training three times weekly for 4 weeks. Anticipated 60 patients will be randomly assigned to active or sham TDCS of ipsilesional M1-HAND, using a central anode and four equidistant cathodes. The placement of the electrode grid on the scalp and current strength at each cathode will be personalized based on individual electrical field models to induce an electrical current of 0.2 V/m in the cortical target region resulting in current strengths between 1 and 4 mA. Primary endpoint will be the difference in change of Fugl-Meyer Assessment of Upper Extremity (FMA-UE) score between active TDCS and sham at the end of the intervention. Exploratory endpoints will include UE-FMA at 12 weeks. Effects of TDCS on motor network connectivity and interhemispheric inhibition will be assessed with functional MRI and transcranial magnetic stimulation. Discussion The study will show the feasibility and test the efficacy of personalized, multi-electrode anodal TDCS of M1-HAND in patients with subacute stroke patients with upper-extremity paresis. Concurrent multimodal brain mapping will shed light into the mechanisms of action of therapeutic personalized TDCS of M1-HAND. Together, the results from this trial may inform future personalized TDCS studies in patients with focal neurological deficits after stroke.

ObjectiveMost studies that have evaluated patient-reported outcomes, such as those utilizing the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 10a (PF10a) in rheumatoid arthritis (RA), have been performed in white and English-speaking populations. The aim of our study was to assess the measurement properties of the PF10a in a racially/ethnically diverse population with RA and to determine the effect of non-English language proficiency, insurance status, and race/ethnicity on the validity and responsiveness of the PF10a.MethodsData were abstracted from electronic health records for all RA patients seen in a university-based rheumatology clinic between 2013 and 2017. We evaluated the use of the PF10a, floor and ceiling effects, and construct validity across categories of language preference, insurance, and race/ethnicity. We used standardized response means and linear mixed-effects models to evaluate the responsiveness of the PF10a to longitudinal changes in the Clinical Disease Activity Index (CDAI) across population subgroups.ResultsWe included 595 patients in a cross-sectional analysis of validity and 341 patients in longitudinal responsiveness analyses of the PF10a. The PF10a had acceptable floor and ceiling effects and was successfully implemented. We observed good construct validity and responsiveness to changes in CDAI among white subjects, English speakers, and privately insured patients. However, constructs evaluated by the PF10a were less correlated with clinical measures among Chinese speakers and Hispanic subjects, and less sensitive to clinical improvements among Medicaid patients and Spanish speakers.ConclusionWhile the PF10a has good measurement properties and is both practical and acceptable for implementation in routine clinical practice, we also found important differences across racial/ethnic groups and those with limited English proficiency that warrant further investigation.

Technology can help health care providers understand their patients' experience of illness in a way that was previously impossible. Experience in using health information technology (IT) to capture this information through PROs within rheumatology suggests that careful attention to human centered design, including detailed workflow planning, consideration of patient and physician burden, integration into the health IT ecosystem, and delivering information to the right person at the right time are all important. Technology applications must be tested in diverse health systems and populations to ensure they are simple to interpret, useful for clinical decision making and effective in impacting outcomes.

ObjectiveUse of patient reported outcomes (PROs) in the routine care of rheumatoid arthritis (RA) has been shown to improve health outcomes, However, integration of PROs into the clinical visit is inconsistent. We aimed to develop a "dashboard" for RA patients to display relevant PRO measures for discussion during a routine RA clinical visit.MethodsPatients (N = 45) and providers (N = 12) were recruited from rheumatology clinics at a university center and a safety net hospital. Using a human-centered design process involving patients, clinicians, designers, and health-IT experts, we performed interviews, clinic observations, and focus groups, which subsequently guided an iterative phase of prototype testing.ResultsRA patients and their providers shared the goals of assessing wellbeing and developing a personalized treatment plan. We found conflicting views of which data were most important for guiding decision-making and for answering the patient's overarching question of "Am I OK?"ConclusionThe final dashboard simplified the display of PRO data and correlated it longitudinally to the patient's medication regimen. It also included laboratory values relevant for RA care.Practice implicationsBy presenting data graphically, the dashboard may provide a platform for patients and providers to communicate around PROs and shared goals.

Inclusion of patient-reported outcomes is important in SLE clinical trials as they allow capture of the benefits of a proposed intervention in areas deemed pertinent by patients. We aimed to compare the measurement properties of health-related quality of life (HRQoL) measures used in adults with SLE and to evaluate their responsiveness to interventions in randomised controlled trials (RCTs). A systematic review was undertaken using full original papers in English identified from three databases: MEDLINE, EMBASE and PubMed. Studies describing the validation of HRQoL measures in English-speaking adult patients with SLE and SLE drug RCTs that used an HRQoL measure were retrieved. Twenty-five validation papers and 26 RCTs were included in the indepth review evaluating the measurement properties of 4 generic (Medical Outcomes Study Short-Form 36 (SF36), Patient Reported Outcomes Measurement Information System (PROMIS) item-bank, EuroQol-5D, and Functional Assessment of Chronic Illness Therapy-Fatigue) and 3 disease-specific (Lupus Quality of Life (LupusQoL), Lupus Patient Reported Outcomes, Lupus Impact Tracker (LIT)) instruments. All measures had good convergent and discriminant validity. PROMIS provided the strongest evidence for known-group validity and reliability among generic instruments; however, data on its responsiveness have not been published. Across measures, standardised response means were generally indicative of poor-moderate sensitivity to longitudinal change. In RCTs, clinically important improvements were reported in SF36 scores from baseline; however, between-arm differences were frequently non-significant and non-important. SF36, PROMIS, LupusQoL and LIT had the strongest evidence for acceptable measurement properties, but few measures aside from the SF36 have been incorporated into clinical trials. This review highlights the importance of incorporating a broader range of SLE-specific HRQoL measures in RCTs and warrants further research that focuses on longitudinal responsiveness of newer instruments.

Background: Consistent evidence suggests a relationship between lower educational attainment and total obesity defined using body mass index (BMI); however, a comparison of the relationships between educational attainment and total obesity (BMI ≥30 kg/m2) and central obesity (waist circumference (WC) > 102 cm for men and WC > 88 cm for women) has yet to be carried out. This systematic literature review (SLR) and meta-analyses aimed to understand whether i) the associations between education and obesity are different depending on the measures of obesity used (BMI and WC), and ii) to explore whether these relationships differ by gender and region. Methods: Medline, Embase and Web of Science were searched to identify studies investigating the associations between education and total and central obesity among adults in the general population of countries in the Organisation for Economic Co-operation and Development (OECD). Meta-analyses and meta-regression were performed in a subset of comparable studies (n=36 studies; 724,992 participants). Results: 86 eligible studies (78 cross-sectional and eight longitudinal) were identified. Among women, most studies reported an association between a lower education and total and central obesity. Among men, there was a weaker association between lower education and central than total obesity (OR central vs total obesity in men 0.79 (95% CI 0.60, 1.03)). The association between lower education and obesity was stronger in women compared with men (OR women vs men 1.66 (95% CI 1.32, 2.08)). The relationship between lower education and obesity was less strong in women from Northern than Southern Europe (OR Northern vs Southern Europe in women 0.37 (95% CI 0.27, 0.51)), but not among men. Conclusions: Associations between education and obesity differ depending on whether total or central obesity is used among men, but not in women. These associations are stronger among women than men, particularly in Southern European countries.

El medidor de clorofila (Minolta SPAD 502) es una herramientapromisoria para monitorear el status de nitrógeno (N) del cultivo, a tra-vés del índice de verdor (IV) y del índice de suficiencia de N (ISN) en hoja.Los objetivos fueron describir la evolución del IV y el ISN durante la esta-ción de crecimiento del cultivo de trigo, y establecer la relación entre elIV y el ISN con el rendimiento y el contenido de proteína en grano. Laexperiencia se realizó en 1997/98, en Balcarce (Buenos Aires), en doslotes que tenían 5 y más de 20 años de agricultura. El P disponible no fuelimitante. Los tratamientos fueron dosis de N (0, 30, 60, 90, 120 y 180 kgN ha-1). El diseño experimental fue en bloques completos aleatorizados(DCBA). El IV permitió monitorear el status de N del cultivo de trigo, yaque presentó valores más altos en el sitio de mayor fertilidad nitrogenaday disminuyó a medida que avanzó el ciclo del cultivo, siendo esta disminución más pronunciada para N0 y más atenuada para180. El ISN se com-portó de manera similar al IV, debido a que se empleó la misma variedadde trigo y prácticas de manejo de cultivo similares. Se determinó una bajarelación entre IV e ISN al macollaje con el rendimiento en grano. A partirde encañazón, se alcanzaron aceptables ajustes entre dichas variables (R2=0.68 a 0.84 para IV; R2= 0.70 a 0.84 para ISN), lo que pone de manifiestosu valor predictivo. En grano lechoso temprano, se determinaron buenosajustes entre IV e ISN y el contenido de proteína en grano (R2= 0.82 paraIV; R2= 0.61 para ISN), indicando que ambos son buenos predictores deeste parámetro

Background: A growing population is living with ischemic heart disease (IHD). Patient-reported outcomes (PROs) are reliable prognostic tools. Studies exploring PROs are needed to identify vulnerable patients and guide targeted healthcare strategies. Objectives: The aims of this study were to (i) describe PROs at hospital discharge across 3 diagnostic subgroups: (1) chronic IHD/stable angina, (2) non-ST-elevation myocardial infarction (non-STEMI)/unstable angina, and (3) ST-elevation myocardial infarction (STEMI), and (ii) examine determinants for PROs at hospital discharge in patients with IHD. Methods: This study included a national cohort with register-data linkage including 14 115 adults with IHD discharged from Danish heart centers. Eligible patients (n = 13 476) were invited to complete a questionnaire, and 7 167 (53%) responded. Questionnaires included the Medical Outcome Study Short-Form 12, the Hospital Anxiety and Depression Scale, EuroQoL, HeartQoL, the Edmonton Symptom Assessment Scale, and ancillary questions. Sociodemographic and clinical characteristics were obtained fromnational registers. Student t test, χ² test, and adjusted linear and logistic regression analyses were conducted to investigate subgroup differences, and adjusted linear and logistic regression analyses were conducted to explore determinants for PROs. Results: Statistically significant subgroup differences were found, with groups reporting worst to best scores for most of PROs being as follows: chronic IHD/stable angina, non-STEMI/unstable angina, and STEMI. Symptoms of anxiety were highly prevalent in the non-STEMI/unstable angina group, with 33.8% exceeding a Hospital Anxiety and Depression Scale--Anxiety cutoff score indicating a possible anxiety disorder. Determinants for worse PROs included female sex, lower educational level, obesity, and poor physical fitness. Conclusions: Significant differences in PROs across IHD subgroups were observed and determinants for poor outcomes suggested. Results may guide differentiated care initiatives and resource allocation for preventative strategies. [ABSTRACT FROM AUTHOR]

Case managers are increasingly used to optimize trajectories for patients. This study is based on a questionnaire among case managers in cancer care, aiming at the clarification of the func­tion and its impact on especially patient safety, when handing over the responsibility. The results show a major variation in how the function is organized, the level of competence and the task to be handled. The responsibility has in general been nar­rowed to department level. Overall, the case managers believe that the function has optimized pathways for cancer patients and improved safety, but barriers persist.