Clinical Research and Data Collection During the Investigation: Influence of a Dedicated Staff

2019 ◽  
Author(s):  
Keyword(s):  
Data Collection ◽  
Clinical Research

scholarly journals Collecting clinical data in primary ciliary dyskinesia- challenges and opportunities

F1000Research ◽  
2016 ◽  
Vol 5 ◽  
pp. 2031 ◽  
Author(s):  
Israel Amirav ◽  
Mary Roduta Roberts ◽  
Huda Mussaffi ◽  
Avigdor Mandelberg ◽  
Yehudah Roth ◽  
...  
Keyword(s):  
Data Collection ◽  
Clinical Research ◽  
Clinical Data ◽  
Primary Ciliary Dyskinesia ◽  
Completion Rates ◽  
End User ◽  
Revision Process ◽  
Data Collection And Analysis ◽  
Challenges And Opportunities ◽  
Ciliary Dyskinesia

Rationale: Primary ciliary dyskinesia (PCD) is under diagnosed and underestimated. Most clinical research has used some form of questionnaires to capture data but none has been critically evaluated particularly with respect to its end-user feasibility and utility. Objective: To critically appraise a clinical data collection questionnaire for PCD used in a large national PCD consortium in order to apply conclusions in future PCD research. Methods: We describe the development, validation and revision process of a clinical questionnaire for PCD and its evaluation during a national clinical PCD study with respect to data collection and analysis, initial completion rates and user feedback. Results: 14 centers participating in the consortium successfully completed the revised version of the questionnaire for 173 patients with various completion rates for various items. While content and internal consistency analysis demonstrated validity, there were methodological deficiencies impacting completion rates and end-user utility. These deficiencies were addressed resulting in a more valid questionnaire. Conclusions: Our experience may be useful for future clinical research in PCD. Based on the feedback collected on the questionnaire through analysis of completion rates, judgmental analysis of the content, and feedback from experts and end users, we suggest a practicable framework for development of similar tools for various future PCD research.

The Esophageal Online Patient Reported Outcomes (EsO-PRO) Questionnaire: Formal implementation and assessment of a combined clinical and research data collection tool.

2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 37-37
Author(s):  
Shirley Xue Jiang ◽  
Shubhangi Shah ◽  
Elliot Charles Smith ◽  
Justine Baek ◽  
Mindy Liang ◽  
...  
Keyword(s):  
Esophageal Cancer ◽  
Data Collection ◽  
Clinical Research ◽  
Demographic Data ◽  
Qualitative Assessment ◽  
Data Collection Tool ◽  
Implementation Barriers ◽  
Survey Tool ◽  
Research Survey ◽  
Patient Reported

37 Background: Systematic symptom monitoring improves quality of life, and possibly overall survival in cancer outpatients receiving chemotherapy. To reduce patient, staff, and resource burden, combining research surveys with electronic PRO assessments in a multidisciplinary academic esophageal cancer clinic may allow dual clinical-research goals to be met. Methods: EsO-PRO is a data collection tool directed at esophageal cancer outpatients created through expert feedback. Using the Canadian Institutes of Health research (CIHR) Knowledge-to-Action (KTA) framework, clinic flow and stakeholder maps were constructed. Facilitators and barriers were then identified, and responses were generated to address implementation barriers. Multiple iterations of the questionnaire were implemented; patient and clinic staff feedback was collected through key informant interviews, and major themes were described. Results: Creation of EsO-PRO included multiple validated tools: the FACT-E, modified Cancer Research UK esophageal cancer risk questionnaire, EQ5D-5L, PRO-CTCAE for common esophageal symptoms, and baseline clinico-demographic data. Four iterations of the KTA cycle for pilot implementation identified specific key facilitators (clinician champions, staff engagement, resource-integration, and clinician-researcher synergy) and barriers (familiarity with technology, survey length, and communication barriers). Qualitative assessment also identified perceived importance of questions as key to patient completion, and role delegation, staff burden, clinic flow interruption as critical issues to address. Splitting EsO-PRO into two separate visits for completion, allowing completion at home, and changing fill-in-the-blanks to check-off boxes were identified as potential solutions. Conclusions: The CIHR-KTA framework identified concrete methods for improved integration of a combined clinical-research survey tool for routine use in a multidisciplinary esophageal cancer outpatient clinic. Our process serves as an effective model for integration of innovations in multidisciplinary esophageal cancer clinics.

scholarly journals Electronic Data Management for Vaccine Trials in Low Resource Settings: Upgrades, Scalability, and Impact of ODK

2021 ◽  
Vol 9 ◽  
Author(s):  
Michael Marks ◽  
Sham Lal ◽  
Hannah Brindle ◽  
Pierre-Stéphane Gsell ◽  
Matthew MacGregor ◽  
...  
Keyword(s):  
Data Collection ◽  
Clinical Research ◽  
Data Management ◽  
Open Source ◽  
Large Scale ◽  
Democratic Republic Of Congo ◽  
World Health ◽  
Electronic Data ◽  
Diverse Range ◽  
Electronic Data Collection

Background: ODK provides software and standards that are popular solutions for off-grid electronic data collection and has substantial code overlap and interoperability with a number of related software products including CommCare, Enketo, Ona, SurveyCTO, and KoBoToolbox. These tools provide open-source options for off-grid use in public health data collection, management, analysis, and reporting. During the 2018–2020 Ebola epidemic in the North Kivu and Ituri regions of Democratic Republic of Congo, we used these tools to support the DRC Ministère de la Santé RDC and World Health Organization in their efforts to administer an experimental vaccine (VSV-Zebov-GP) as part of their strategy to control the transmission of infection.Method: New functions were developed to facilitate the use of ODK, Enketo and R in large scale data collection, aggregation, monitoring, and near-real-time analysis during clinical research in health emergencies. We present enhancements to ODK that include a built-in audit-trail, a framework and companion app for biometric registration of ISO/IEC 19794-2 fingerprint templates, enhanced performance features, better scalability for studies featuring millions of data form submissions, increased options for parallelization of research projects, and pipelines for automated management and analysis of data. We also developed novel encryption protocols for enhanced web-form security in Enketo.Results: Against the backdrop of a complex and challenging epidemic response, our enhanced platform of open tools was used to collect and manage data from more than 280,000 eligible study participants who received VSV-Zebov-GP under informed consent. These data were used to determine whether the VSV-Zebov-GP was safe and effective and to guide daily field operations.Conclusions: We present open-source developments that make electronic data management during clinical research and health emergencies more viable and robust. These developments will also enhance and expand the functionality of a diverse range of data collection platforms that are based on the ODK software and standards.

scholarly journals Methodological description of clinical research data collection through electronic medical records in a center participating in an international multicenter study

2019 ◽  
Vol 17 (4) ◽  
Author(s):  
Veronica Neves Fialho Queiroz ◽  
Andrea da Costa Moreira de Oliveira ◽  
Renato Carneiro de Freitas Chaves ◽  
Lucas Araújo de Borges Moura ◽  
Daniel Sousa César ◽  
...  
Keyword(s):  
Data Collection ◽  
Clinical Research ◽  
Electronic Medical Records ◽  
Multicenter Study ◽  
Medical Records ◽  
Research Data ◽  
International Multicenter Study ◽  
International Multicenter ◽  
Clinical Research Data

PARE0029 THE JOURNEY FROM PATIENT AND PUBLIC ENGAGEMENT (PPE) TO INVOLVEMENT: FACILITATING PATIENT PARTNER RESEARCH WORKSHOPS WITH A FOCUS ON FIBROFOG IN FIBROMYALGIA

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1300.1-1301
Author(s):  
S. Derham ◽  
M. Brooke
Keyword(s):  
Data Collection ◽  
Clinical Research ◽  
Rheumatic Diseases ◽  
Public Engagement ◽  
Health Care Professionals ◽  
Health Research ◽  
Healthcare Professionals ◽  
Local Networks ◽  
Patient And Public Engagement ◽  
Research Questions

Background:The Bath Institute for Rheumatic Diseases (BIRD), a registered charity in the United Kingdom (UK), supports research, education and patient engagement for the benefit of people with rheumatic diseases. Event feedback from two Fibromyalgia Information Days showed patients valued the sessions and were keen to be involved in research. Fibrofog in fibromyalgia was identified by patients as one topic of interest.Objectives:To facilitate Patient Research Partner Workshops to generate research questions and inform the design of clinical research into fibrofog in fibromyalgia.Methods:Three Patient Research Partner Workshops, focusing on fibrofog in fibromyalgia, were run between January 2018 and April 2019. All were co-facilitated by a clinician, SD, and BIRD Patient and Public Engagement (PPE) lead,MB. Ethical approval was not required1. Patients were invited to participate by email. A Patient Partner Information Sheet accompanied the workshop invitation. Audio recordings of the discussions were made to aid data capture, following informed written consent by all workshop participants. Travel expenses were offered to all participants.Results:25 (n=25) women with fibromyalgia attended the workshops. Workshop 1 (n= 5) explored, ‘What areas do you think we should research around fibrofog in fibromyalgia’? Patient partners felt research into fibrofog in fibromyalgia was needed to identify and validate symptoms, and to inform discussions with healthcare professionals. They also called for research into coping strategies to help with fibrofog symptoms. This reflected similar patient calls for research into fibrofog in fibromyalgia2.Workshop 2 (n=10) and Workshop 3 (n=9) explored ‘How do you think we should research fibrofog in fibromyalgia’? Both workshops identified a broad range of research questions and designs, reflecting individual experiences, knowledge and symptom severity. Suggested research questions included: How severe is fibrofog for each person? What triggers fibrofog? How does fibrofog affect daily tasks? How does fibrofog affect work? What do people with fibromyalgia, their partners, family members and healthcare professionals understand about fibrofog?Suggested data collection methods included interviews, focus groups and questionnaires. Use of online surveys or interviews had mixed responses. This reflected computer literacy skills and access to hardware. Discussions around recruitment of participants to future studies revealed a wealth of local knowledge including access to community venues and healthcare facilities, support groups and local networks.Participants were very satisfied with the workshops, finding them helpful, informative and thought provoking. All wanted to continue their involvement in research.Conclusion:Patient Research Partner Workshops are integral to the generation and delivery of clinical research into fibrofog in fibromyalgia. Research designs need to offer multiple methods of data collection to be as inclusive as possible. Next steps will be to formally recruit Patient Research Partners to co-develop a research grant application to explore fibrofog in fibromyalgia.References:[1]INVOLVE. Public involvement in research and research ethics committee review V.2 Southampton: INVOLVE/Health Research Authority; 2016 [Available from:https://www.invo.org.uk/wp-content/uploads/2016/05/HRA-INVOLVE-updated-statement-2016.pdf.[2]Fitzcharles, M.-A., Brachaniec, M., Cooper, L., Dubin, R., Flynn, T., Gerhold, K., Häuser, W., Cowan, K., Laupacis, A., Marleau, R., Milot, M., Szajcz-Keller, N., Sumpton, J., Walsh, Z. & El-Gabalawy, H. 2017. A paradigm change to inform fibromyalgia research priorities by engaging patients and health care professionals.Canadian Journal of Pain,1, 137-147.Acknowledgments:This work was supported by the National Institute for Health research [ICA-PCAF-2018-01-078 to SD]Disclosure of Interests:Sandra Derham: None declared, Mel Brooke Grant/research support from: Sponsorship from Lilly to BIRD for the Patient and Public Engagement Programme, Sponsorship from Sanofi to BIRD for the Healthcare Professionals Education Programme.

Abstract WP203: National Institute of Neurological Disorders and Stroke Common Data Elements: Public Review and Updates to the Stroke Recommendations

Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Katelyn Gay ◽  
Damon Collie ◽  
Muniza Sheikh ◽  
Joy Esterlitz ◽  
Jeffrey Saver ◽  
...  
Keyword(s):  
Data Collection ◽  
Clinical Research ◽  
Neurological Disorders ◽  
Vital Signs ◽  
Cerebral Aneurysms ◽  
Research Data ◽  
Common Data Element ◽  
Common Data Elements ◽  
Stroke Research ◽  
Data Elements

Objective: The National Institute of Neurological Disorders and Stroke (NINDS) initiated the Common Data Element (CDE) project to provide standardized clinical research data collection formats that increase the efficiency and effectiveness of studies and reduce start-up time, as well as improve data quality and facilitate and accelerate data sharing. In 2010, Stroke-specific CDEs were posted on the NINDS CDE website. The Stroke Oversight Committee (OC) reviewed Core CDEs in 2015; and in 2018, recommended that Stroke CDEs undergo a comprehensive review and update to Version 2.0. Background: In August 2018, a Stroke V2.0 Working Group (WG) consisting of over 50 worldwide subject matter experts was convened by NINDS. The WG was asked to review all current Stroke CDEs and subarachnoid hemorrhage and unruptured cerebral aneurysms (SAH) CDEs (developed in 2017) for harmonization and inclusion within Stroke V2.0. Methods: The Stroke V2.0 WG divided into eight domain-specific subgroups: Biospecimens, Biomarkers, and Laboratory Tests; Hospital Course and Acute Therapies; Imaging; Long Term Therapies; Medical History and Prior Health Status; Outcomes and Endpoints; Stroke Presentation and Vital Signs; and Stroke Types and Subtypes. Subgroups met regularly to review, revise and add to the existing Stroke CDEs based on developments in stroke research. Following an internal WG review, a public review of the draft updates will be held. The WG will consider public feedback before V2.0 is finalized. The Stroke OC plans to review the project status at the 2020 International Stroke Conference. Results: The Stroke V2.0 CDE recommendations will include updated and new template case report forms, data dictionaries, instrument informational documents and guideline documents. The updates will reflect the current state of science, streamline CDE recommendations, and incorporate SAH CDEs. Stroke V2.0 CDEs will be available on the NINDS CDE website in 2020. Conclusions: The NINDS CDEs are periodically revised as research progresses. Through the update of the Stroke CDEs to V2.0, the initiative strives to maintain the utility of CDEs as a valuable clinical research resource. NINDS encourages use of CDEs to standardize research data collection across studies.

Fundamentals of Data Collection in Clinical Studies: Simple Steps to Avoid “Garbage In, Garbage Out”

2020 ◽  
pp. 153473462093823
Author(s):  
José G. B. Derraik ◽  
Wason Parklak ◽  
Benjamin B. Albert ◽  
Kongsak Boonyapranai ◽  
Kittipan Rerkasem
Keyword(s):  
Data Collection ◽  
Clinical Research ◽  
Clinical Studies ◽  
Poor Quality ◽  
Early Career ◽  
High Quality ◽  
Quality Research ◽  
Early Career Researchers ◽  
Key Aspects ◽  
Collection And Management

Many fundamental steps underpin the delivery of high-quality clinical research. In this article, we provide a brief commentary on some important aspects associated with the collection and management of data during clinical studies, which, if overlooked, will lead to poor-quality research. In particular, we discuss the key aspects that should help early career researchers maximize the relevance and impact of their clinical research.

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