scholarly journals 2507

2017 ◽  
Vol 1 (S1) ◽  
pp. 20-20
Author(s):  
Ram Gouripeddi ◽  
Elizabeth Lane ◽  
Randy Madsen ◽  
Ryan Butcher ◽  
Bernie LaSalle ◽  
...  
Keyword(s):  
Back Pain ◽  
Clinical Research ◽  
Patient Record ◽  
Patient Records ◽  
User Centered Design ◽  
Clinical Workflow ◽  
Eligibility Criteria ◽  
Study Population ◽  
Data Elements ◽  
Research Studies

OBJECTIVES/SPECIFIC AIMS: Issues with recruiting the targeted number of participants in a timely manner often results in underpowered studies, with more than 60% of clinical studies failing to complete or requiring extensions due to enrollment issues. The objective of this study is to develop and implement a scalable, organization wide platform to enhance accrual into clinical research studies. METHODS/STUDY POPULATION: We are developing and evaluating an informatics platform called Utah Utility for Research Recruitment (U2R2). U2R2 consists of 2 components: (i) Semantic Matcher: an automated trial criterion to patient matching component that also reports uncertainty associated with the match, and (ii) Match Delivery: mechanisms to deliver the list of matched patients for different research and clinical settings. As a first step, we limited the Semantic Matcher to utilize only structured data elements from the patient record and trial criteria. We are now including distributional semantic methods to match complete patient records and trial criteria as documents. We evaluated the first phase of U2R2 based on a randomized trial with a target enrollment of 220 participants that compares 2 treatment strategies for managing back pain (physical therapy and usual care) for individuals consulting a nonsurgical provider and symptomatic <90 days. RESULTS/ANTICIPATED RESULTS: U2R2 identified 9370 patients from the University of Utah Hospitals and Clinics as potential matches. Of these 9370, 1145 responded to the Back Pain study research team’s email or phone communications, and were further screened by phone. In total, 250 participants completed a screening visit, resulting in the current study enrollment of 130 participants. Forty-three of 1145 patients refused to participate, and 50 participants no-showed their screening visit. DISCUSSION/SIGNIFICANCE OF IMPACT: A recruitment platform can enhance potential participant identification, but requires attention to multiple issues involved with clinical research studies. Clinical eligibility criteria are usually unstructured and require human mediation and abstraction into discrete data elements for matching against patient records. In addition, key eligibility data are often embedded within text in the patient record. Distributional semantic approaches, by leveraging this content, can identify potential participants for screening with more specificity. The delivery of the list of matched patient results should consider characteristics of the research study, population, and targeted enrollment (eg, back pain being a common disorder and the possibility of the patient visiting different types of clinics), as well as organizational and socio-technical issues surrounding clinical practice and research. Embedding the delivery of match results into the clinical workflow by utilizing user-centered design approaches and involving the clinician, the clinic, and the patient in the recruitment process, could yield higher accrual indices.

User-centered design principles in the development of clinical research tools

2020 ◽  
Vol 17 (6) ◽  
pp. 703-711
Author(s):  
Anita Walden ◽  
Lynsi Garvin ◽  
Michelle Smerek ◽  
Constance Johnson
Keyword(s):  
Clinical Research ◽  
Design Principles ◽  
Acceptance Testing ◽  
Small Scale ◽  
User Centered Design ◽  
Evaluation Phase ◽  
Patient Reported ◽  
Study Participants ◽  
User Centered ◽  
Research Studies

Background: Increasing and sustaining the engagement of participants in clinical research studies is a goal for clinical investigators, especially for studies that require long-term or frequent involvement of participants. Technology can be used to reduce barriers to participation by providing multiple options for clinical data entry and form submission. However, electronic systems used in clinical research studies should be user-friendly while also ensuring data quality. Directly involving study participants in evaluating the effectiveness and usability of electronic tools may promote wider adoption, maintain involvement, and increase user satisfaction of the technology. While developers of healthcare applications have incorporated user-centered designs, these methods remain uncommon in the design of clinical study tools such as patient-reported outcome surveys or electronic data capture digital health tools. Methods: Our study evaluated whether the clinical research setting may benefit from implementing user-centered design principles. Study participants were recruited to test the web-based form for the Measurement to Understand the Reclassification of Disease of Cabarrus/Kannapolis (MURDOCK) Study Community Translational Population Health Registry and Biorepository that would enable them to complete their study forms electronically. The study enrollment form collects disease history, conditions, smoking status, medications, and other information. The system was initially evaluated by the data management team through traditional user-acceptance testing methods. During the tool evaluation phase, a decision was made to incorporate a small-scale usability study to directly test the system. Results: Results showed that a majority of participants found the system easy to use. Of the eight required tasks, 75% were completed successfully. Of the 72 heuristics violated, language was the most frequent violation. Conclusion: Our study showed that user-centered usability methods can identify important issues and capture information that can enhance the participant’s experience and may improve the quality of study tools.

scholarly journals Analysis of Requirements for the Medication Profile to Be Used in Clinical Research: Protocol Feasibility Studies and Patient Recruitment

2015 ◽  
Vol 2015 ◽  
pp. 1-10
Author(s):  
Julie M. James ◽  
Dipak Kalra ◽  
Jane Portlock
Keyword(s):  
Clinical Research ◽  
Feasibility Studies ◽  
Patient Recruitment ◽  
Eligibility Criteria ◽  
Related Data ◽  
Electronic Health ◽  
Data Elements ◽  
Electronic Health Information ◽  
Core Part ◽  
Research Domain

A “Medication Profile,” the information about the medicines a person is using and has used, is a core part of many electronic health record systems and summaries. However, there is little objective research into the data elements that the profile should contain to support the uses it must serve. With the increasing emphasis on secondary uses of electronic health information, as well as supporting the requirements to support direct to patient care, the Medication Profile should also support the requirements from clinical research. However, there is little, if any, description of these available. This paper describes an analysis of a set of study eligibility criteria that was undertaken to investigate which medication-related data elements would be required to support two clinical research use cases: the parameters to query a patient’s Medication Profile to assess their suitability for entry into a trial (patient recruitment) and the parameters to query a set of Medication Profiles in a data warehouse to assess whether the eligibility criteria as described would yield a reasonable cohort of patients as potential subjects (protocol feasibility). These medication-related data elements then become information requirements that a Medication Profile should ideally meet, in order to be able to support these two uses in the clinical research domain.

Frequency Analysis of Medical Concepts in Clinical Trials and their Coverage in MeSH and SNOMED-CT

2015 ◽  
Vol 54 (01) ◽  
pp. 83-92 ◽  
Author(s):  
M. Dugas ◽  
J. Varghese
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Significance Test ◽  
University Hospital ◽  
Free Text ◽  
Snomed Ct ◽  
Eligibility Criteria ◽  
Unified Medical Language System ◽  
Data Elements ◽  
Medical Concepts

Summary Background: Eligibility criteria (EC) of clinical trials play a key role in selecting appropriate study candidates and the validity of the outcome of a clinical trial. However, in most cases EC are provided in unstandardised ways such as free text, which raises significant challenges for machine-readability. Objectives: To establish a list of most frequent medical concepts in clinical trials with semantic annotations. This concept list contributes to standardisation of EC and identifies relevant data items in electronic health records (EHRs) for clinical research. The coverage of the list in two major clinical vocabularies, MeSH and SNOMED-CT, will be assessed. Methods: Four hundred and twenty-fivec linical trials conducted between 2000 and 2011 at a German university hospital were analysed. 6671 EC were manually annotated by a medical coder using Concept Unique Identifiers (CUIs) provided by the Unified Medical Language System. Two physicians performed a semi-automatic CUI code revision. Concept frequency was analysed and clusters of concepts were manually identified.A binomial significance test was applied to quantify coverage differences of the most frequent concepts in MeSH and SNOMED-CT. Results: Based on manual medical coding of 425 clinical trials, 7588 concepts were identified, of which 5236 were distinct. A top 100 list containing 101 most frequent medical concepts was established. The concepts of this list cover 25 % of all concept occur-rences in all analysed clinical trials. This list reveals six missing entries in SNOMED-CT, 12 in MeSH. The median of EC frequency per trial has increased throughout the trial years (2000 –2005: 8 EC/trial, 2011: 14 EC/ trial). Conclusions: Relatively few concepts cover one quarter of concept occurrences that represent EC in recent studies. Therefore, these concepts can serve as candidate data elements for integration into EHRs to optimise patient recruitment in clinical research.

scholarly journals Does Altruism Affect Participation in Cancer Research? A Systematic Review

2021 ◽  
Author(s):  
Danny HJ Heo ◽  
M. Juanita Rodriguez ◽  
Megan McNichol ◽  
A. James Moser
Keyword(s):  
Systematic Review ◽  
Cancer Research ◽  
Clinical Research ◽  
Cancer Patients ◽  
Social Exchange ◽  
Published Data ◽  
Structured Interviews ◽  
Eligibility Criteria ◽  
The Impact ◽  
Research Studies

Abstract Background: The impact of altruism on enrollment and longitudinal follow-up among cancer patients participating in clinical research studies remains poorly understood. This systematic review assesses published data reporting altruism as a motivator in cancer research and derives objective definitions of the four subtypes of altruism to permit future investigation in prospective therapeutic and non-therapeutic studies.Method: A qualitative systematic review of altruism and cancer was conducted according PRISMA after a literature search of PubMed, Embase, Cochrane, and PsychINFO databases. Study aims, methodology, outcomes, and conclusions were extracted to perform qualitative analysis of altruistic motivations among cancer research participants. Quality and risk of bias were assessed using the Joanna Briggs Institute (JBI) Critical Appraisal tool for Systematic Reviews Checklist for Qualitative Research. Results: Of 78 full-text manuscripts, fourteen met eligibility criteria for analysis, all of which used semi-structured interviews or questionnaires to study subsets of cancer patients participating in therapeutic clinical trials or non-therapeutic biobanking. Four distinct subtypes of altruism were demonstrated and defined according to an association map having the following four domains: personal benefit, benefit to family (kinship), benefit to others, and social exchange. Conclusion: Different types of altruism among cancer patients were observed both in therapeutic and non-therapeutic studies. Altruism remains as an underrecognized factor that affects clinical research studies.

The Separation of Reviewing Knowledge from Medical Knowledge

1995 ◽  
Vol 34 (01/02) ◽  
pp. 131-139 ◽  
Author(s):  
M. A. Musen ◽  
J. van der Lei
Keyword(s):  
Medical Knowledge ◽  
Patient Record ◽  
Patient Records ◽  
Computer Based ◽  
New Challenges ◽  
Arden Syntax

Abstract:The developers of reviewing systems that rely on computer-based patient-record systems as a source of data need to model reviewing knowledge and medical knowledge. We simulate how the same medical knowledge could be entered in four different systems: CARE, the Arden syntax, Essential-attending and HyperCritic. We subsequently analyze how the original knowledge is represented in the symbols or syntax used by these systems. We conclude that these systems provide different alternatives in dealing with the vocabulary provided by the computer-based patient records. In addition, the use of computer-based patient records for review poses new challenges for the content of that record: to facilitate review, the reasoning of the physician needs to be captured in addition to the actions of the physician.

scholarly journals A systematic review of criteria used to report complications in soft tissue and oncologic surgical clinical research studies in dogs and cats

2019 ◽  
Vol 49 (1) ◽  
pp. 61-69 ◽  
Author(s):  
Christelle M. Follette ◽  
Michelle A. Giuffrida ◽  
Ingrid M. Balsa ◽  
William T. N. Culp ◽  
Philipp D. Mayhew ◽  
...  
Keyword(s):  
Systematic Review ◽  
Soft Tissue ◽  
Clinical Research ◽  
Research Studies

scholarly journals THU0528 NAILFOLD VIDEOCAPILLAROSCOPY REPORTING IN CLINICAL RESEARCH: INTERNATIONAL DELPHI BASED CONSENSUS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 503.1-504
Author(s):  
F. Ingegnoli ◽  
T. Schioppo ◽  
A. Herrick ◽  
A. Sulli ◽  
F. Bartoli ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Research ◽  
Rheumatic Diseases ◽  
Unmet Need ◽  
Future Research ◽  
Invasive Technique ◽  
Delphi Consensus ◽  
Research Support ◽  
The Impact ◽  
Research Studies

Background:Nailfold capillaroscopy (NVC), a non-invasive technique to assess microcirculation, is increasingly being incorporated into rheumatology routine clinical practice. Currently, the degree of description of NVC methods varies amongst research studies, making interpretation and comparison between studies challenging. In this field, an unmet need is the standardization of items to be reported in research studies using NVC.Objectives:To perform a Delphi consensus on minimum reporting standards in methodology for clinical research, based on the items derived from a systematic review focused on this topic.Methods:The systematic review of the literature on NVC methodology relating to rheumatic diseases was performed according to PRISMA guidelines (PROSPERO CRD42018104660) to July 22nd2018 using MEDLINE, Embase, Scopus. Then, a three-step web-based Delphi consensus was performed in between members of the EULAR study group on microcirculation in rheumatic diseases and the Scleroderma Clinical Trials Consortium. Participants were asked to rate each item from 1 (not appropriate) to 9 (completely appropriate).Results:In total, 3491 references were retrieved in the initial search strategy, 2862 were excluded as duplicates or after title/abstract screening. 632 articles were retrieved for full paper review of which 319 fulfilled the inclusion criteria. Regarding patient preparation before the exam, data were scarce: 38% reported acclimatization, 5% to avoid caffeine and smoking, 3% to wash hands and 2% to avoid manicure. Concerning the device description: 90% reported type of instrument, 77% brand/model, 72% magnification, 46% oil use, 40% room temperature and 35% software for image analysis. As regards to examination details: 76% which fingers examined, 75% number of fingers examined, 15% operator experience, 13% reason for finger exclusion, 9% number of images, 8% quality check of the images and 3% time spent for the exam. Then, a three-round Delphi consensus on the selected items was completed by 80 participants internationally, from 31 countries located in Australia, Asia, Europe, North and South America. Some items reached the agreement at the second round (85 participants), and other items were suggested as important to consider in a future research agenda (e.g. temperature for acclimatization, the impact of smoking, allergies at the application of the oil to the nailbed, significance of pericapillary edema, methods of reporting hemorrhages, ramified and giant capillaries). The final agreement results are reported below:Conclusion:On the basis of the available literature the description of NVC methods was highly heterogeneous and individual published studies differed markedly. These practical suggestions developed using a Delphi process among international participants provide a guidance to improve and to standardize the NVC methodology in future clinical research studies.Disclosure of Interests:Francesca Ingegnoli: None declared, Tommaso Schioppo: None declared, Ariane Herrick: None declared, Alberto Sulli Grant/research support from: Laboratori Baldacci, Francesca Bartoli: None declared, Nicola Ughi: None declared, John Pauling: None declared, Maurizio Cutolo Grant/research support from: Bristol-Myers Squibb, Actelion, Celgene, Consultant of: Bristol-Myers Squibb, Speakers bureau: Sigma-Alpha, Vanessa Smith Grant/research support from: The affiliated company received grants from Research Foundation - Flanders (FWO), Belgian Fund for Scientific Research in Rheumatic diseases (FWRO), Boehringer Ingelheim Pharma GmbH & Co and Janssen-Cilag NV, Consultant of: Boehringer-Ingelheim Pharma GmbH & Co, Speakers bureau: Actelion Pharmaceuticals Ltd, Boehringer-Ingelheim Pharma GmbH & Co and UCB Biopharma Sprl

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