Improving Diagnosis and Care for Patients With Sarcoma: Do Real-World General Practitioners Data and Prospective Data Collections Have a Place Next to Clinical Trials?

There has been growing interest in the use of real-world data (RWD) to address clinically and policy-relevant (research) questions that cannot be answered with data from randomized controlled trials (RCTs) alone. This is, for example, the case in rare malignancies such as sarcomas as limited patient numbers pose challenges in conducting RCTs within feasible timeliness, a manageable number of collaborators, and statistical power. This narrative review explores the potential of RWD to generate real-world evidence (RWE) in sarcoma research, elucidating its application across different phases of the patient journey, from prediagnosis to the follow-up/survivorship phase. For instance, examining electronic health records (EHRs) from general practitioners (GPs) enables the exploration of consultation frequency and presenting symptoms in primary care before a sarcoma diagnosis. In addition, alternative study designs that integrate RWD with well-designed observational RCTs may offer relevant information on the effectiveness of clinical treatments. As, especially in cases of ultrarare sarcomas, it can be an extreme challenge to perform well-powered randomized prospective studies. Therefore, it is crucial to support the adaptation of novel study designs. Regarding the follow-up/survivorship phase, examining EHR from primary and secondary care can provide valuable insights into identifying the short- and long-term effects of treatment over an extended follow-up period. The utilization of RWD also comes with several challenges, including issues related to data quality and privacy, as described in this study. Notwithstanding these challenges, this study underscores the potential of RWD to bridge, at least partially, gaps between evidence and practice and holds promise in contributing to the improvement of sarcoma care.

Support tool to strengthen health information systems: guidance for health information system assessment and strategy development

It is essential for policy-makers to have a reliable and clear picture of how health is distributed in a given population, and what indicators contribute to or reduce opportunities to be healthy. Therefore, the surveillance of population health and well-being is the first of ten essential public health operations defined by WHO. WHO has a long tradition of providing support to Member States to strengthen their health information systems (HISs). Support tool to strengthen health information systems, is only one of WHO tools which provides guidance for HIS assessment and strategy development.The tool was first published in 2015, and an updated version was published in 2021. Current edition contains refined assessment methodology for the core module and four new add-on modules – Emergency response information management system, Geographic information system, Long-term care, and Migration health data - complementing the add-on modules included in the 2021 update (Health data governance, Health information for the Thirteenth General Programme of Work and the European Programme of Work 2020–2025, Human resources for health, Infectious disease surveillance, and Noncommunicable diseases monitoring).The tool has two main parts: guidance for performing an assessment of a full HIS and guidance for the subsequent development of an HIS strategy. The assessment methodology aims to achieve a good balance between data collection and actual data use and reflects the growing importance of electronic health records and other digital solutions. Add-on modules provide support for a more in-depth assessment of specific functions of HISs. Based on the outcomes of the assessment, the tool describes a stepwise and practical approach for HIS strategy development. The HIS assessment item sheets that are part of the assessment methodology are also available in the form of an excel sheet and published as a separate Web Annex.

Exploring the research needs, barriers and facilitators to the collection of biological data in adolescence for mental health research: a scoping review protocol paper.

INTRODUCTION: While research into adolescent mental health has developed a considerable understanding of environmental and psychosocial risk factors, equivalent biological evidence is lacking and is not representative of economic, social and ethnic diversity in the adolescent population. It is important to understand the possible barriers and facilitators to conduct this research. This will then allow us to improve our understanding of how biology interacts with environmental and psychosocial risk factors during adolescence. The objective of this scoping review is to identify and understand the needs, barriers and facilitators related to the collection of biological data in adolescent mental health research. METHODS AND ANALYSIS: Reviewers will conduct a systematic search of PubMed, Medline, Scopus, Cochrane, ERIC, EMBASE, ProQuest, EBSCO Global Health electronic databases, relevant publications and reference lists to identify studies published in the English language at any time. This scoping review will identify published studies exploring mental health/psychopathology outcomes, with biological measures, in participants between the ages of 11 and 18 and examine the reported methodology used for data collection. Data will be summarised in tabular form with narrative synthesis and will use the methodology of Levac et al, supplemented by subsequent recommendations from the Joanna Briggs Institute Scoping Review Methodology. ETHICS AND DISSEMINATION: Ethical approval is not required for this scoping review. The scoping review will be conducted with input from patient and public involvement, specifically including young people involved in our study ('Co-producing a framework of guiding principles for Engaging representative and diverse cohorts of young peopLE in Biological ReseArch in menTal hEalth'-www.celebrateproject.co.uk) Youth Expert Working Group. Dissemination will include publication in peer-reviewed journals, academic presentations and on the project website.

Development and Utility of an Interactive Online Dashboard for Monitoring Data Collection and Data Processing During a School-Based Health Survey.

We built an interactive online dashboard using Google Looker Studio to monitor data collection and data processing activities during the Adolescent Health Survey (AHS) 2022, a large-scale nationwide survey conducted among school-going adolescents in Malaysia. Through user testing and training, refinements were made to the initial dashboard, resulting in a more streamlined and concise dashboard design. The dashboard comprised 2 pages that provided key metrics on the progress of data collection and data processing, respectively. The introduction of the dashboard enhanced the quality and ease of weekly progress reporting during meetings of the survey's central coordinating team, while its drill-down and filtering functionalities helped us detect arising issues early and supported collaborative problem-solving. Research teams coordinating comparable school-based health surveys are invited to duplicate the dashboard using Looker Studio's built-in "Make a copy" function and customize it further based on their country- or survey-specific requirements.

Why and how to collect representative study samples in educational neuroscience research.

BACKGROUND: Educational neuroscience research, which investigates the neurobiological mechanisms of learning, has historically incorporated samples drawn mostly from white, middle-class, and/or suburban populations. However, sampling in research without attending to representation can lead to biased interpretations and results that are less generalizable to an intended target population. Prior research revealing differences in neurocognitive outcomes both within- and across-groups further suggests that such practices may obscure significant effects with practical implications. BARRIERS: Negative attitudes among historically marginalized communities, stemming from historical mistreatment, biased research outcomes, and implicit or explicit attitudes among research teams, can hinder diverse participation. Qualities of the research process including language requirements, study locations, and time demands create additional barriers. SOLUTIONS: Flexible data collection approaches, community engaugement, and transparent reporting could build trust and enhance sampling diversity. Longer-term solutions include prioritizing research questions relevant to marginalized communities, increasing workforce diversity, and detailed reporting of sample demographics. Such concerted efforts are essential for robust educational neuroscience research to maximize positive impacts broadly across learners.

Precious Information: Getting Interpretable, Actionable Health Communications Data.

Doing high-quality health communications requires high-quality data, both to describe information environments and diets and as outcomes for program evaluations that seek to change them and the behaviors they foster. When we understand where people gather information, what they learn there, and how it encourages them to act, we can better diagnose where to focus energy and resources-for example, whether to amplify high-quality sources, address low-quality information, or fill information voids with actionable ideas. Too often, however, researchers collect data in ways that conflate the sources of information, the channels through which information is communicated, and the content of that information. This thwarts opportunities to identify specific problems and opportunities. We call for conceptual precision to make good use of respondents' time, to be good stewards of funders' money, and to effectively address the large challenges we face in encouraging protective, pro-social health behaviors.

Routine Collection of Patient-Reported Data to Support the Needs of Primary Care Within an Integrated Healthcare System.

Ontario Health Teams (OHTs), models of integrated care, are responsible for measuring and improving patient experience. However, routine collection of patient-reported data has not been fully realized, presenting a significant system-wide gap. We conducted a pilot study to implement routine collection of patient-reported data in the Frontenac, Lennox and Addington (FLA) OHT. Each clinic integrated the survey, which captured encounter experience, health and well-being and demographics into their workflow. During the five-month pilot, over 1,200 patients shared their experiences. Clinics reported that the data were valuable for ongoing quality improvement, boosting staff morale and providing a voice to patients. Each site needed flexibility for deployment and to ensure that they captured data relevant to their practice needs. A balance is needed to meet differing needs at each level of the system, requiring cross-sectoral commitment for integrated care systems to truly understand the patient experience and health of the population.

Effectiveness of remote risk-based monitoring and potential benefits for combination with direct data capture.

BACKGROUND: In recent years, alternative monitoring approaches, such as risk-based and remote monitoring techniques, have been recommended instead of traditional on-site monitoring to achieve more efficient monitoring. Remote risk-based monitoring (R2BM) is a monitoring technique that combines risk-based and remote monitoring and focuses on the detection of critical data and process errors. Direct data capture (DDC), which directly collects electronic source data, can facilitate R2BM by minimizing the extent of source documents that must be reviewed and reducing the additional workload on R2BM. In this study, we evaluated the effectiveness of R2BM and the synergistic effect of combining R2BM with DDC. METHODS: R2BM was prospectively conducted with eight participants in a randomized clinical trial using a remote monitoring system that uploaded photographs of source documents to a cloud location. Critical data and processes were verified by R2BM, and later, all were confirmed by on-site monitoring to evaluate the ability of R2BM to detect critical data and process errors and the workload of uploading photographs for clinical trial staff. In addition, the reduction of the number of uploaded photographs was evaluated by assuming that the DDC was introduced for data collection. RESULTS: Of the 4645 data points, 20.9% (n = 973, 95% confidence interval = 19.8-22.2) were identified as critical. All critical data errors corresponding to 5.4% (n = 53/973, 95% confidence interval = 4.1-7.1) of the critical data and critical process errors were detectable by R2BM. The mean number of uploaded photographs and the mean time to upload them per visit per participant were 34.4 ± 11.9 and 26.5 ± 11.8 min (mean ± standard deviation), respectively. When assuming that DDC was introduced for data collection, 45.0% (95% confidence interval = 42.2-47.9) of uploaded photographs for R2BM were reduced. CONCLUSIONS: R2BM can detect 100% of the critical data and process errors without on-site monitoring. Combining R2BM with DDC reduces the workload of R2BM and further improves its efficiency.

Data Collection in Dental Research: A Practitioner's Guide.

Data collection is a fundamental process in any scientific investigation. This article outlines best practices for three general elements of the data-collection process: (1) determining the specific aim, (2) design, and (3) documentation. We discuss these elements in the style of a tutorial, using extended examples specific to dental research. Each section of the tutorial concludes with a bullet-point summary for ease of reference to the readers. The supplemental material for this article includes templates designed to assist dental researchers in initiating the data-collection process in their respective research efforts, and selected references are organized by topic. Although written for an audience of clinical scientists in dentistry, the principles outlined here could be generalized to other health science research contexts.

The Advanced BRain Imaging on ageing and Memory (ABRIM) data collection: Study design, data processing, and rationale.

To understand the neurocognitive mechanisms that underlie heterogeneity in cognitive ageing, recent scientific efforts have led to a growing public availability of imaging cohort data. The Advanced BRain Imaging on ageing and Memory (ABRIM) project aims to add to these existing datasets by taking an adult lifespan approach to provide a cross-sectional, normative database with a particular focus on connectivity, myelinization and iron content of the brain in concurrence with cognitive functioning, mechanisms of reserve, and sleep-wake rhythms. ABRIM freely shares MRI and behavioural data from 295 participants between 18-80 years, stratified by age decade and sex (median age 52, IQR 36-66, 53.20% females). The ABRIM MRI collection consists of both the raw and pre-processed structural and functional MRI data to facilitate data usage among both expert and non-expert users. The ABRIM behavioural collection includes measures of cognitive functioning (i.e., global cognition, processing speed, executive functions, and memory), proxy measures of cognitive reserve (e.g., educational attainment, verbal intelligence, and occupational complexity), and various self-reported questionnaires (e.g., on depressive symptoms, pain, and the use of memory strategies in daily life and during a memory task). In a sub-sample (n = 120), we recorded sleep-wake rhythms using an actigraphy device (Actiwatch 2, Philips Respironics) for a period of 7 consecutive days. Here, we provide an in-depth description of our study protocol, pre-processing pipelines, and data availability. ABRIM provides a cross-sectional database on healthy participants throughout the adult lifespan, including numerous parameters relevant to improve our understanding of cognitive ageing. Therefore, ABRIM enables researchers to model the advanced imaging parameters and cognitive topologies as a function of age, identify the normal range of values of such parameters, and to further investigate the diverse mechanisms of reserve and resilience.

A dataset on survey designs and quality of social and behavioral science surveys during the COVID-19 pandemic.

In the social and behavioral sciences, surveys are frequently used to collect data. During the COVID-19 pandemic, surveys provided political actors and public health professionals with timely insights on the attitudes and behaviors of the general population. These insights were key in guiding actions to fight the pandemic. However, the data quality of these surveys remains unclear because systematic knowledge about how the survey data were collected during the COVID-19 pandemic is lacking. This is unfortunate, since decades of survey research have shown that survey design impacts data. Our Survey Data Collection and the COVID-19 Pandemic (SDCCP) project deals with this research gap. We collected rich metadata on survey design for 717 social and behavioral science surveys carried out in Germany during the first two years of the COVID-19 pandemic. In this data descriptor, we present a unique resource for a systematic assessment of the survey data collection practices and quality of surveys conducted in Germany during the COVID-19 pandemic.

Protocol for the Evaluation of Data-Related Processes and Challenges at Level 1-4 Trauma Centers in Arkansas: A Mixed-Methods Case Study.

Background: In the following manuscript, we describe the detailed protocol for a mixed-methods, observational case study conducted to identify and evaluate existing data-related processes and challenges currently faced by trauma centers in a rural state. The data will be utilized to assess the impact of these challenges on registry data collection. Methods: The study relies on a series of interviews and observations to collect data from trauma registry staff at level 1-4 trauma centers across the state of Arkansas. A think-aloud protocol will be used to facilitate observations to gather keystroke-level modeling data and insight into site processes and workflows for collecting and submitting data to the Arkansas Trauma Registry. Informal, semi-structured interviews will follow the observation period to assess the participant's perspective on current processes, potential barriers to data collection or submission to the registry, and recommendations for improvement. Each session will be recorded, and de-identified transcripts and session notes will be used for analysis. Keystroke level modeling data derived from observations will be extracted and analyzed quantitatively to determine time spent performing end-to-end registry-related activities. Qualitative data from interviews will be reviewed and coded by 2 independent reviewers following a thematic analysis methodology. Each set of codes will then be adjudicated by the reviewers using a consensus-driven approach to extrapolate the final set of themes. Discussion: We will utilize a mixed methods approach to understand existing processes and barriers to data collection for the Arkansas Trauma Registry. Anticipated results will provide a baseline measure of the data collection and submission processes at various trauma centers across the state. We aim to assess strengths and limitations of existing processes and identify existing barriers to interoperability. These results will provide first-hand knowledge on existing practices for the trauma registry use case and will provide quantifiable data that can be utilized in future research to measure outcomes of future process improvement efforts. The potential implications of this study can form the basis for identifying potential solutions for streamlining data collection, exchange, and utilization of trauma registry data for clinical practice, public health, and clinical and translational research.

Recruitment, data collection, participation rate, and representativeness of the international cross-sectional PRICOV-19 study across 38 countries.

BACKGROUND: Recruitment for surveys has been a great challenge, especially in general practice. METHODS: Here, we reported recruitment strategies, data collection, participation rates (PR) and representativeness of the PRICOV-19 study, an international comparative, cross-sectional, online survey among general practices (GP practices) in 37 European countries and Israel. RESULTS: Nine (24%) countries reported a published invitation; 19 (50%) had direct contact with all GPs/GP practices; 19 (50%) contacted a sample of GPs /GP practices; and 7 (18%) used another invitation strategy. The median participation rate was 22% (IQR = 10%, 28%). Multiple invitation strategies (P-value 0.93) and multiple strategies to increase PR (P-value 0.64) were not correlated with the PR. GP practices in (semi-) rural areas, GP practices serving more than 10,000 patients, and group practices were over-represented (P-value < 0.001). There was no significant correlation between the PR and strength of the primary care (PC) system [Spearman's r 0.13, 95% CI (-0.24, 0.46); P-value 0.49]; the COVID-19 morbidity [Spearman's r 0.19, 95% CI (-0.14, 0.49); P-value 0.24], or COVID-19 mortality [Spearman's r 0.19, 95% CI (-0.02, 0.58); P-value 0.06] during the three months before country-specific study commencement. CONCLUSION: Our main contribution here was to describe the survey recruitment and representativeness of PRICOV-19, an important and novel study.

Collecting routine and timely cancer stage at diagnosis by implementing a cancer staging tiered framework: the Western Australian Cancer Registry experience.

BACKGROUND: Current processes collecting cancer stage data in population-based cancer registries (PBCRs) lack standardisation, resulting in difficulty utilising diverse data sources and incomplete, low-quality data. Implementing a cancer staging tiered framework aims to improve stage collection and facilitate inter-PBCR benchmarking. OBJECTIVE: Demonstrate the application of a cancer staging tiered framework in the Western Australian Cancer Staging Project to establish a standardised method for collecting cancer stage at diagnosis data in PBCRs. METHODS: The tiered framework, developed in collaboration with a Project Advisory Group and applied to breast, colorectal, and melanoma cancers, provides business rules - procedures for stage collection. Tier 1 represents the highest staging level, involving complete American Joint Committee on Cancer (AJCC) tumour-node-metastasis (TNM) data collection and other critical staging information. Tier 2 (registry-derived stage) relies on supplementary data, including hospital admission data, to make assumptions based on data availability. Tier 3 (pathology stage) solely uses pathology reports. FINDINGS: The tiered framework promotes flexible utilisation of staging data, recognising various levels of data completeness. Tier 1 is suitable for all purposes, including clinical and epidemiological applications. Tiers 2 and 3 are recommended for epidemiological analysis alone. Lower tiers provide valuable insights into disease patterns, risk factors, and overall disease burden for public health planning and policy decisions. Capture of staging at each tier depends on data availability, with potential shifts to higher tiers as new data sources are acquired. CONCLUSIONS: The tiered framework offers a dynamic approach for PBCRs to record stage at diagnosis, promoting consistency in population-level staging data and enabling practical use for benchmarking across jurisdictions, public health planning, policy development, epidemiological analyses, and assessing cancer outcomes. Evolution with staging classifications and data variable changes will futureproof the tiered framework. Its adaptability fosters continuous refinement of data collection processes and encourages improvements in data quality.

Reflections on co-managing investigative praxis in the context of a health emergency. / Reflexões sobre práxis investigativa cogestora em contexto de emergência sanitária.

This article deals with the interest of the scientific field in systematizing the co-management investigative praxis, in a health emergency scenario, based on the analysis of a research with a multicentric qualitative approach, using the framework of the Support Research and the analysis of critical hermeneutics. As a result, it was identified that the creation of a map guide contributed as a guiding document, aiming at organizing different techniques for the organization and formation of field researchers, as well as an instrument of data analysis. The training of researchers for the theoretical framework of Support Research, as well as their co-management and involvement in the different stages of research, proved to be a differential for the production of subjects and collectives with investigative praxis, allowing a dialogic exchange between coordinators and researchers and regular sharing of the results. It is concluded that the way in which the methodology was proposed, allowed the expansion of the reflective capacity and understanding of reality, contributing to the formation of researchers as active and critical subjects in the process of data collection, analysis and discussion, encouraging sensitive and attentive actions while seeking to identify the particularities of each context.

O artigo trata do interesse do campo científico em sistematizar a práxis investigativa cogestora em cenário de emergência sanitária a partir da análise de uma pesquisa de abordagem qualitativa multicêntrica, valendo-se do referencial da pesquisa-apoio e da análise da hermenêutica critica. Como resultados, identificou-se que a elaboração de um guia-mapa contribuiu como documento norteador, com o objetivo de organizar diferentes técnicas para a preparação e formação dos pesquisadores de campo, também como instrumento de análise dos dados. A formação de pesquisadores para o referencial teórico da pesquisa-apoio, assim como a cogestão e a implicação deles nas diferentes etapas da pesquisa, mostrou-se como diferencial para produção de sujeitos e coletivos com a práxis investigativa, permitindo a troca dialógica dentre coordenadores e pesquisadores e o compartilhamento regular dos resultados. Conclui-se que a forma como a metodologia foi proposta possibilitou a ampliação da capacidade reflexiva e de compreensão sobre a realidade, contribuindo para a formação de pesquisadores como sujeitos ativos e críticos no processo de coleta, análise e discussão dos dados, incentivando a atuação sensível e atenta ao mesmo tempo em que buscou identificar as particularidades de cada contexto.

Improving quality of care by standardising patient data collection in electronic medical records in an oncology department in Spain.

BACKGROUND: Evaluation of quality of care in oncology is key in ensuring patients receive adequate treatment. American Society of Clinical Oncology's (ASCO) Quality Oncology Practice Initiative (QOPI) Certification Program (QCP) is an international initiative that evaluates quality of care in outpatient oncology practices. METHODS: We retrospectively reviewed free-text electronic medical records from patients with breast cancer (BR), colorectal cancer (CRC) or non-small cell lung cancer (NSCLC). In a baseline measurement, high scores were obtained for the nine disease-specific measures of QCP Track (2021 version had 26 measures); thus, they were not further analysed. We evaluated two sets of measures: the remaining 17 QCP Track measures, as well as these plus other 17 measures selected by us (combined measures). Review of data from 58 patients (26 BR; 18 CRC; 14 NSCLC) seen in June 2021 revealed low overall quality scores (OQS)-below ASCO's 75% threshold-for QCP Track measures (46%) and combined measures (58%). We developed a plan to improve OQS and monitored the impact of the intervention by abstracting data at subsequent time points. RESULTS: We evaluated potential causes for the low OQS and developed a plan to improve it over time by educating oncologists at our hospital on the importance of improving collection of measures and highlighting the goal of applying for QOPI certification. We conducted seven plan-do-study-act cycles and evaluated the scores at seven subsequent data abstraction time points from November 2021 to December 2022, reviewing 404 patients (199 BR; 114 CRC; 91 NSCLC). All measures were improved. Four months after the intervention, OQS surpassed the quality threshold and was maintained for 10 months until the end of the study (range, 78-87% for QCP Track measures; 78-86% for combined measures). CONCLUSIONS: We developed an easy-to-implement intervention that achieved a fast improvement in OQS, enabling our Medical Oncology Department to aim for QOPI certification.

Standardizing data collection in adjuvant colon cancer trials: A consensus project from the IDEA and ACCENT international consortia and national experts.

BACKGROUND: Despite contributions provided by the recent clinical trials, several issues and challenges still remain unsolved in adjuvant colon cancer (CC). Hence, further studies should be planned to better refine risk assessment as well as to establish the optimal treatment strategy in the adjuvant setting. However, it is necessary to request adequate, contemporary and relevant variables and report them homogeneously in order to bring maximal information when analyzing their prognostic value. MATERIAL AND METHODS: The project was devised to gain a consensus from experts engaged in the planning, accrual and analyses of stage II and III CC clinical trials, to identify mandatory and recommended baseline variables in order to i) harmonize future data collection worldwide in clinical trials dedicated to adjuvant treatment of CC; ii) propose guidance for Case Report Forms to be used for clinical trials in this setting. A total of 72 questions related to variables that should be reported and how to report them in adjuvant clinical trials were approved and then voted to reach a final consensus from panelists. RESULTS: Data items on patient-related factors, histopathological features, molecular profile, circulating biomarkers and blood analyses were analyzed and discussed by the whole expert panel. For each item, we report data supporting the acquired consensus and the relevant issues that were discussed. Nineteen items were deemed to be mandatory for resected stage III patients and 24 for resected stage II disease. In addition, 9 and 4 items were judged as recommended for stage III and II, respectively. CONCLUSION: In our opinion, these 28 variables should be used and uniformly reported in more comprehensive CRFs as research groups design future clinical trials in the field of adjuvant colon cancer.