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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.

Background Brucellosis, as a serious zoonotic infectious disease, has been recognized as a re-emerging disease in the developing countries worldwide. In china, the incidence of brucellosis is increasing each year, seriously threatening the health of humans as well as animal populations. Despite a quite number of diagnostic methods currently being used for brucellosis, innovative technologies are still needed for its rapid and accurate diagnosis, especially in area where traditional diagnostic is unavailable. Methodology/Principal findings In this study, a total of 22 B cell linear epitopes were predicted from five Brucella outer membrane proteins (OMPs) using an immunoinformatic approach. These epitopes were then chemically synthesized, and with the method of indirect ELISA (iELISA), each of them displayed a certain degree of capability in identifying human brucellosis positive sera. Subsequently, a fusion protein consisting of the 22 predicted epitopes was prokaryotically expressed and used as diagnostic antigen in a newly established brucellosis testing method, nano-ZnO modified paper-based ELISA (nano-p-ELISA). According to the verifying test using a collection of sera collected from brucellosis and non-brucellosis patients, the sensitivity and specificity of multiepitope based nano-p-ELISA were 92.38% and 98.35% respectively. The positive predictive value was 98.26% and the negative predictive value was 91.67%. The multiepitope based fusion protein also displayed significantly higher specificity than Brucella lipopolysaccharide (LPS) antigen. Conclusions B cell epitopes are important candidates for serologically testing brucellosis. Multiepitope fusion protein based nano-p-ELISA displayed significantly sensitivity and specificity compared to Brucella LPS antigen. The strategy applied in this study will be helpful to develop rapid and accurate diagnostic method for brucellosis in human as well as animal populations., Author summary Brucellosis is one of the most important zoonosis in the world and has caused tremendous economic losses in agriculture and animal husbandry in many countries. Developing rapid, sensitive and specific diagnostic methods is very important for early detection and treatment of brucellosis patients. In this study, a novel diagnostic technique, nano-ZnO modified paper ELISA, was established. The antigen used in this technique was a fusion protein containing multiple B cell epitopes, which were predicted from Brucella major outer membrane proteins such as Bp26, Omp31, Omp16, Omp2b and Omp25. Comparing to traditional LPS antigen, this multiepitope based antigen displayed considerably higher sensitivity and higher specificity in laboratory. With the strategy described in this paper, more efficient epitopes and protein antigen can be identified in the future. Currently, LPS antigen is only prepared from live Brucella, while protein antigen can be produced in large quantities in prokaryotic expression system. In addition to nano-p-ELISA, this protein antigen can also be used for development other methods such as fluorescent polarization assay (FPA) and immunochromatographic assay (ICA) to meet the varied demand for brucellosis testing.

Background Mobile health (mHealth) tools may be useful platforms for dietary monitoring and assessment. Objective This study aims to evaluate the effectiveness of a mobile dietary self-monitoring app for weight loss versus a paper-based diary among adults with a BMI of 23 kg/m2 or above. Methods A total of 33 men and 17 women aged 18-39 years participated in a 6-week randomized controlled trial. We randomly assigned participants to one of two groups: (1) a smartphone app group (n=25) or (2) a paper-based diary group (n=25). The smartphone app group recorded foods and dietary supplements that they consumed and received immediate dietary feedback using Well-D, a dietary self-monitoring app developed by our team. The paper-based diary group was instructed to record foods or supplements that they consumed using a self-recorded diary. The primary outcomes were weight, BMI, waist circumference, body fat mass, and skeletal muscle mass. We also examined changes in nutrient intake, including energy, carbohydrate, protein, fat, dietary fiber, vitamins, and minerals, using 3-day 24-hour recalls. Differences in changes between the two groups were analyzed using independent t tests or Wilcoxon Mann-Whitney tests. All of the data were analyzed using intent-to-treat analysis. Results The mean number of days recorded was 18.5 (SD 14.1) for the app group and 15.5 (SD 10.1) for the paper-based diary group. The differences in changes in weight, BMI, and waist circumference were not significantly different between the app group and paper-based diary group (P=.33, .34, and .70, respectively). Similarly, changes in body fat mass or skeletal muscle mass did not differ between the two groups (P=.71 and .054, respectively). Although energy intake was reduced in both groups, there was no significant difference in changes in energy intake between the two groups (P=.98). Conclusions There were no differences in changes in anthropometric measures and nutrient intake between the app group and the paper-based diary group. Both mobile dietary self-monitoring app and paper-based diary may be useful for improving anthropometric measures. Trial Registration Clinical Research Information Service KCT0003170; https://cris.nih.go.kr/cris/search/search_result_st01_en.jsp?seq=11642&ltype=&rtype=

Background The Syria crisis has forced more than 4 million people to leave their homeland. As a result, in 2016, an overwhelming number of refugees reached Germany. In response to this, it was of utmost importance to set up refugee camps and to provide humanitarian aid, but a health surveillance system was also implemented in order to obtain rapid information about emerging diseases. Objective The present study describes the effects of using digital paper and pen (DPP) technology on the speed, sequence, and behavior of epidemiological documentation in a refugee camp. Methods DPP technology was used to examine documentation speed, sequence, and behavior. The data log of the digital pens used to fill in the documentation was analyzed, and each pen stroke in a field was recorded using a timestamp. Documentation time was the difference between first and last stroke on the paper, which includes clinical examination and translation. Results For three months, 495 data sets were recorded. After corrections had been made, 421 data sets were considered valid and subjected to further analysis. The median documentation time was 41:41 min (interquartile range 29:54 min; mean 45:02 min; SD 22:28 min). The documentation of vital signs ended up having the strongest effect on the overall time of documentation. Furthermore, filling in the free-text field clinical findings or therapy or measures required the most time (mean 16:49 min; SD 20:32 min). Analysis of the documentation sequence revealed that the final step of coding the diagnosis was a time-consuming step that took place once the form had been completed. Conclusions We concluded that medical documentation using DPP technology leads to both an increase in documentation speed and data quality through the compliance of the data recorders who regard the tool to be convenient in everyday routine. Further analysis of more data sets will allow optimization of the documentation form used. Thus, DPP technology is an effective tool for the medical documentation process in refugee camps.

Background Global estimates for cholera annually approximate 4 million cases worldwide with 95,000 deaths. Recent outbreaks, including Haiti and Yemen, are reminders that cholera is still a global health concern. Cholera outbreaks can rapidly induce high death tolls by overwhelming the capacity of health facilities, especially in remote areas or areas of civil unrest. Recent studies demonstrated that stool specimens preserved on filter paper facilitate molecular analysis of Vibrio cholerae in resource limited settings. Specimens preserved in a rapid, low-cost, safe and sustainable manner for sequencing provides previously unavailable data about circulating cholera strains. This may ultimately contribute new information to shape public policy response on cholera control and elimination. Methodology/Principal findings Whole genome sequencing (WGS) recovered close to a complete sequence of the V. cholerae O1 genome with satisfactory genome coverage from stool specimens enriched in alkaline peptone water (APW) and V. cholerae culture isolates, both spotted on filter paper. The minimum concentration of V. cholerae DNA sufficient to produce quality genomic information was 0.02 ng/μL. The genomic data confirmed the presence or absence of genes of epidemiological interest, including cholera toxin and pilus loci. WGS identified a variety of diarrheal pathogens from APW-enriched specimen spotted filter paper, highlighting the potential for this technique to explore the gut microbiome, potentially identifying co-infections, which may impact the severity of disease. WGS demonstrated that these specimens fit within the current global cholera phylogenetic tree, identifying the strains as the 7th pandemic El Tor. Conclusions WGS results allowed for mapping of short reads from APW-enriched specimen and culture isolate spotted filter papers. This provided valuable molecular epidemiological sequence information on V. cholerae strains from remote, low-resource settings. These results identified the presence of co-infecting pathogens while providing rare insight into the specific V. cholerae strains causing outbreaks in cholera-endemic areas., Author summary Cholera affects more than 4 million people globally every year; people predominantly living in poverty or in resource-constrained conditions including political crises or natural disasters. Cholera’s typical presentation is characterized by rapid onset of acute watery diarrhea and vomiting which can progress from watery stool to shock in as little as four hours. Laboratory conditions needed for culture confirmation and strain preservation are rarely to never present in these affected areas. In fact, many cholera endemic areas in Sub-Saharan African are so remote that even treatment response alone is often challenging. Here we present the genomic analysis of DNA extracted from dried filter paper, which is a low-cost, low-tech and sustainable method. Previously this method has facilitated cholera confirmation by PCR, but we demonstrate that this method is also suitable for whole genome sequencing and subsequent strain characterization by presenting the analysis of samples from an outbreak in a remote area of Cameroon. This method will facilitate the understanding of the molecular epidemiology in cholera-prone areas, which were previously too challenging to attempt. It also introduces a method that can be used on a broader scale for diarrheal disease surveillance, including providing a window into co-infection and microbiome analyses.

Background Many of the 70,000 graduating US medical students [per year] have reported participating in a global health activity at some stage of medical school. This case study design provided a method for understanding the student's experience that included student’s learning about culture, health disparities, exposure and reaction to a range of diseases actually encountered. The broad diversity of themes among students indicated that the GCE provided a flexible, personalized experience. We need to understand the student’s experience in order to help design appropriate curricular experiences [and valid student assessment]. Objective Our research aim was to analyze medical student reflection papers to understand how they viewed their Global Clinical Experience (GCE). Methods A qualitative case study design was used to analyze student reflection papers. All 28 students who participated in a GCE from 2008-2010 and in 2014-2015 and submitted a reflection paper on completion of the GCE were eligible to participate in the study. One student did not submit a reflection paper and was not included in the study. Findings All 27 papers were coded by paragraph for reflection and for themes. System of Care/Range of Care was mentioned most often, Aids to Adjustment Process was mentioned least. The theme, “Diseases,” referred to any mention of a disease in the reflection papers, and 44 diseases were mentioned in the papers. The analysis for depth of reflection yielded the following data: Observation, 81/248 paragraphs; Observation and Interpretation, 130/248 paragraphs; and Observation, Interpretation, and Suggestions for change, 36/248 paragraphs; 9 reflection papers contained 27 separate accounts of a transformational experience. Conclusions This study provided a method for understanding the student's experience that included student’s learning about culture, health disparities, and exposure and reaction to a range of diseases actually encountered. The broad diversity of themes among students indicated that the GCE provided a flexible, personalized experience. How we might design a curriculum to facilitate transformational learning experiences needs further research.

Background Many patients with chronic obstructive pulmonary disease (COPD) suffer from exacerbations, a worsening of their respiratory symptoms that warrants medical treatment. Exacerbations are often poorly recognized or managed by patients, leading to increased disease burden and health care costs. Objective This study aimed to examine the effects of a smart mobile health (mHealth) tool that supports COPD patients in the self-management of exacerbations by providing predictions of early exacerbation onset and timely treatment advice without the interference of health care professionals. Methods In a multicenter, 2-arm randomized controlled trial with 12-months follow-up, patients with COPD used the smart mHealth tool (intervention group) or a paper action plan (control group) when they experienced worsening of respiratory symptoms. For our primary outcome exacerbation-free time, expressed as weeks without exacerbation, we used an automated telephone questionnaire system to measure weekly respiratory symptoms and treatment actions. Secondary outcomes were health status, self-efficacy, self-management behavior, health care utilization, and usability. For our analyses, we used negative binomial regression, multilevel logistic regression, and generalized estimating equation regression models. Results Of the 87 patients with COPD recruited from primary and secondary care centers, 43 were randomized to the intervention group. We found no statistically significant differences between the intervention group and the control group in exacerbation-free weeks (mean 30.6, SD 13.3 vs mean 28.0, SD 14.8 weeks, respectively; rate ratio 1.21; 95% CI 0.77-1.91) or in health status, self-efficacy, self-management behavior, and health care utilization. Patients using the mHealth tool valued it as a more supportive tool than patients using the paper action plan. Patients considered the usability of the mHealth tool as good. Conclusions This study did not show beneficial effects of a smart mHealth tool on exacerbation-free time, health status, self-efficacy, self-management behavior, and health care utilization in patients with COPD compared with the use of a paper action plan. Participants were positive about the supportive function and the usability of the mHealth tool. mHealth may be a valuable alternative for COPD patients who prefer a digital tool instead of a paper action plan. Trial Registration ClinicalTrials.gov NCT02553096; https://clinicaltrials.gov/ct2/show/NCT02553096.

Background Virtual reality (VR) and augmented reality (AR) interventions are emerging as promising tools in the treatment of pediatric chronic pain conditions. However, in this young field, there is little consensus to guide the process of engaging in the development and evaluation of targeted VR-based interventions. Objective The INOVATE-Pain (Interdisciplinary Network on Virtual and Augmented Technologies for Pain management) consortium aims to advance the field of VR for pediatric chronic pain rehabilitation by providing guidance for best practices in the design, evaluation, and dissemination of VR-based interventions targeting this population. Methods An interdisciplinary meeting of 16 academics, clinicians, industry partners, and philanthropy partners was held in January 2020. Results Reviewing the state of the field, the consortium identified important directions for research-driven innovation in VR and AR clinical care, highlighted key opportunities and challenges facing the field, and established a consensus on best methodological practices to adopt in future efforts to advance the research and practice of VR and AR in pediatric pain. The consortium also identified important next steps to undertake to continue to advance the work in this promising new area of digital health pain interventions. Conclusions To realize the promise of this realm of innovation, key ingredients for success include productive partnerships among industry, academic, and clinical stakeholders; a uniform set of outcome domains and measures for standardized evaluation; and widespread access to the latest opportunities, tools, and resources. The INOVATE-Pain collaborative hopes to promote the creation, rigorous yet efficient evaluation, and dissemination of innovative VR-based interventions to reduce pain and improve quality of life for children.

BackgroundHealth information systems are crucial to provide data for decision-making and demand for data is constantly growing. However, the link between data and decisions is not always rational or linear and the management of data ends up overloading frontline health workers, which may compromise quality of healthcare delivery. Despite limited evidence, there is an increasing push for the digitalization of health information systems, which poses enormous challenges, particularly in remote, rural settings in low- and middle-income countries. Paper-based tools will continue to be used in combination with digital solutions and this calls for efforts to make them more responsive to local needs. Paper-based Health Information Systems in Comprehensive Care (PHISICC) is a transdisciplinary, multi-country research initiative to create and test innovative paper-based health information systems in three sub-Saharan African countries.Methods/DesignThe PHISICC initiative is being carried out in remote, rural settings in Côte d’Ivoire, Mozambique and Nigeria through partnership with ministries of health and research institutions. We began with research syntheses to acquire the most up-to-date knowledge on health information systems. These were coupled with fieldwork in the three countries to understand the current design, patterns and contexts of use, and healthcare worker perspectives. Frontline health workers, with designers and researchers, used co-creation methods to produce the new PHISICC tools. This suite of tools is being tested in the three countries in three cluster-randomized controlled trials. Throughout the project, we have engaged with a wide range of stakeholders and have maintained the highest scientific standards to ensure that results are relevant to the realities in the three countries.DiscussionWe have deployed a comprehensive research approach to ensure the robustness and future policy uptake of findings. Besides the innovative PHISICC paper-based tools, our process is in itself innovative. Rather than emphasizing the technical dimensions of data management, we focused instead on frontline health workers’ data use and decision-making. By tackling the whole scope of primary healthcare areas rather than a subset of them, we have developed an entirely new design and visual language for a suite of tools across healthcare areas. The initiative is being tested in remote, rural areas where the most vulnerable live.

BackgroundThere is increasing recognition that personalized approaches may be more effective in helping people establish healthier eating patterns and exercise more, and that this approach may be particularly effective in adolescents. ObjectiveThe objective of this study was to investigate the use of a smartphone app (FoodWiz2) in supporting healthy lifestyle choices in adolescence. MethodsParticipants (N=34: 11 male, 23 female) aged 16-19 years in full- or part-time education were recruited from sixth form colleges, schools, and other further education establishments in Norfolk and Suffolk, United Kingdom, between February and May 2015. Participants recorded food intake and exercise using a paper diary for 4-5 weeks and then used the app for the same duration. Initial nutrition education and general support were provided during the paper diary use, but the app included personalized messages sent in response to app activity. At the end of each study phase, participants completed an online questionnaire to describe their experience of using the paper diary and app. ResultsRecord completion declined throughout the study, possibly affected by examination pressure. Food intake data showed increased fruit consumption and significantly reduced consumption of chocolate snacks (P=.01) and fizzy drinks (P=.002) among participants using the app. Questionnaire responses indicated that the app was generally preferred to the paper diary, in particular, the app was seen as less boring to use (P=.03) and more acceptable in social settings (P

Roma populations' low health status and limited access to health services, including primary care, has been documented in many European countries, and warrants specific health policies and practices. A variety of experiences shows how primary care can adjust its practices to reduce the barriers to primary care for Roma populations. At local level, establishing collaboration with Roma organisations helps primary care to improve mutual relations and quality of care. Mediation has proved to be an effective tool. Skills training of primary care practitioners may enhance their individual competences. Research and international sharing of experiences are further tools to improve primary care for the Roma people.Slabo zdravstveno stanje romskega prebivalstva ter omejen dostop do zdravstvenih storitev, kar vključuje tudi osnovno zdravstveno stanje, je zabeleženo v več evropskih državah in potrjuje določena zdravstvena načela in dejavnosti.Različne izkušnje prikazujejo načine, kako se lahko osnovno zdravstveno varstvo prilagodi dejavnostim za zmanjšanje ovir med osnovnim zdravstvenim varstvom in romskim prebiovalstvom. Vzpostavljanje sodelovanja z romskimi organizacijami na lokalni ravni lahko pripromore k skupnim povezavam in kakovostni oskrbi na področju osnovnega zdravstvenega varstva. Posredovanje se je izkazalo za učinkovito orodje.Usposabljanje izvajalcev osnovnega zdravstvenega varstva lahko izboljša zmožnosti posameznika. Orodja za izboljšanje osnovnega zdravstvenega varstva za romsko prebivalstvo so nadaljnje raziskave in primerjanje izkušenj na mednarodni ravni.

This discussion paper addresses the safety of HIV cure studies, particularly those involving stopping antiretroviral therapy, known as an analytic treatment interruption (ATI) in the context of the SARS-CoV-2 pandemic. More than 30 studies listed on ClinicalTrials.gov include an ATI and many others were planned to begin over the next 12 months but most were halted due to the COVID-19 pandemic. We consider the ethics, risks and practical considerations to be taken into account before re-opening HIV cure clinical trials, noting the specific risks of ATI in the context of circulating SARS-CoV-2.

The Coronavirus Disease 2019 (COVID-19) has had a continuous and robust impact on world health. The resulting COVID-19 pandemic has had a devastating physical, mental and fiscal impact on the millions of people living with noncommunicable diseases (NCDs). In addition to older age, people living with CVD, stroke, obesity, diabetes, kidney disease, and hypertension are at a particularly greater risk for severe forms of COVID-19 and its consequences. Meta-analysis indicates that hypertension, diabetes, chronic kidney disease, and thrombotic complications have been observed as both the most prevalent and most dangerous co-morbidities in COVID-19 patients. And despite the nearly incalculable physical, mental, emotional, and economic toll of this pandemic, forthcoming public health figures continue to place cardiovascular disease as the number one cause of death across the globe in the year 2020. The world simply cannot wait for the next pandemic to invest in NCDs. Social determinants of health cannot be addressed only through the healthcare system, but a more holistic multisectoral approach with at its basis the Sustainable Development Goals (SDGs) is needed to truly address social and economic inequalities and build more resilient systems. Yet there is reason for hope: the 2019 UN Political Declaration on UHC provides a strong framework for building more resilient health systems, with explicit calls for investment in NCDs and references to fiscal policies that put such investment firmly within reach. By further cementing the importance of addressing circulatory health in a future Framework Convention on Emergency Preparedness, WHO Member States can take concrete steps towards a pandemic-free future. As the chief representatives of the global circulatory health community and patients, the Global Coalition for Circulatory Health calls for increased support for the healthcare workforce, global vaccine equity, embracing new models of care and digital health solutions, as well as fiscal policies on unhealthy commodities to support these investments.

Background Traditional data collection methods using paper and email are increasingly being replaced by data collection using mobile phones, although there is limited evidence evaluating the impact of mobile phone technology as part of an automated research management system on data collection and health outcomes. Objective The aim of this study is to compare a web-based mobile phone automated system (MPAS) with a more traditional delivery and data collection system combining paper and email data collection (PEDC) in a cohort of breastfeeding women. Methods We conducted a substudy of a randomized controlled trial in Sydney, Australia, which included women with uncomplicated term births who intended to breastfeed. Women were recruited within 72 hours of giving birth. A quasi-randomized number of women were recruited using the PEDC system, and the remainder were recruited using the MPAS. The outcomes assessed included the effectiveness of data collection, impact on study outcomes, response rate, acceptability, and cost analysis between the MPAS and PEDC methods. Results Women were recruited between April 2015 and December 2016. The analysis included 555 women: 471 using the MPAS and 84 using the PEDC. There were no differences in clinical outcomes between the 2 groups. At the end of the 8-week treatment phase, the MPAS group showed an increased response rate compared with the PEDC group (56% vs 37%; P Conclusions MPAS is an effective and acceptable method for improving the overall management, treatment compliance, and methodological quality of clinical research to ensure the validity and reliability of findings.