scholarly journals Design, Implementation and Management of an International Medical Device Registry

2021 ◽  
Author(s):  
Herbert Mauch ◽  
Jasmin Kaur ◽  
Colin Irwin ◽  
Josie Wyss
Keyword(s):  
Data Quality ◽  
Medical Device ◽  
Data Entry ◽  
Easy Access ◽  
Clinical Routine ◽  
International Registry ◽  
Site Monitoring ◽  
Patient Reported ◽  
Measurement Tools ◽  
The Cost

Abstract Background Registries are powerful clinical investigational tools. More challenging, however, is an international registry conducted by industry. That requires considerable planning, clear objectives and endpoints, resources and appropriate measurement tools. Methods This paper aims to summarize our learning from ten years of running a medical device registry monitoring patient-reported benefits from hearing implants. Results We enlisted 113 participating clinics globally, resulting in a total enrolment of more than 1500 hearing-implant users. We identify the stages in developing a registry specific to a sensory handicap such as hearing loss, its challenges and successes in design and implementation, and recommendations for future registries. Conclusions Data collection infrastructure needs to be maintained up to date throughout the defined registry lifetime and provide adequate oversight of data quality and completeness. Compliance at registry sites is important for data quality and needs to be weighed against the cost of site monitoring. To motivate sites to provide accurate and timely data entry we facilitated easy access to their own data which helped to support their clinical routine. Trial registration: ClinicalTrials.gov NCT02004353

scholarly journals Design, implementation, and management of an international medical device registry

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Herbert Mauch ◽  
Jasmin Kaur ◽  
Colin Irwin ◽  
Josie Wyss
Keyword(s):  
Data Quality ◽  
Medical Device ◽  
Easy Access ◽  
Clinical Routine ◽  
Design And Implementation ◽  
Site Monitoring ◽  
Patient Reported ◽  
Measurement Tools ◽  
The Cost

Abstract Background Registries are powerful clinical investigational tools. Although in hospitals registries may be mandated, industry-sponsored, international registries are voluntary and therefore can require clearer objectives and more planning. The registry also needs sufficient resources and appropriate measurement tools to motivate long-term participation and ensure success. Methods We summarize our learnings from 10 years of running a medical device registry that surveys patient-reported benefits of hearing implants. Results We enlisted 77 participating clinics globally, who actively recruited a total of more than 1500 hearing implant users. We identified the stages in developing a registry specific to hearing loss. Furthermore, we report the challenges and successes in design and implementation and make recommendations for future registries. Conclusions Data collection infrastructure needs to be kept up to date throughout the defined registry lifetime, and it is essential to oversee data quality and completeness. Compliance at registry sites is important for data quality and needs to be weighed against the cost of site monitoring. To motivate sites to enter data accurately and expeditiously, we facilitated easy access to their own data which helped to support their clinical routine. Trial registration ClinicalTrials.gov NCT02004353. 9th December 2013.

scholarly journals Data Quality – Whose Responsibility is it?

2018 ◽  
Vol 2 ◽  
Author(s):  
Arthur Chapman
Keyword(s):  
Data Quality ◽  
Data Entry ◽  
Improve Quality ◽  
Museum Collections ◽  
Biodiversity Data ◽  
Quality Principles ◽  
General Data ◽  
The Cost ◽  
Level Of Importance

The quality of biodiversity data is an on-going issue. Early efforts to improve quality go back at least 4 decades, but it has never risen to the level of importance that it should have. For far too long the push to database more and more data regardless of its quality has taken priority. So I pose the question - what is the use of having lots of data if 1) we don’t know what its quality is, and 2) if much of it is not fit for use? When data-basing of herbarium and museum collections began in the 1970s many taxonomists saw the only use of the data as being for taxonomic purposes. But as more and more data has become digitally available, so too the uses to which the data can be put. It has also become increasingly important that the data we have in our herbaria and museums be put to more uses to justify on-going support and funding. But whose responsibility is data quality? To answer that I take you to general data quality principles – i.e. that the difficulty and the cost of improving the quality of the data increases the further you move from its source. Responsibility for data quality rests with everyone. Collectors of the specimens Database designers and builders Data entry operators Data curators and managers Those responsible for exchanging/exporting the data Data aggregators Data publishers Data users Collectors of the specimens Database designers and builders Data entry operators Data curators and managers Those responsible for exchanging/exporting the data Data aggregators Data publishers Data users We all have responsibilities. So, what can we each do to play our part? We need to work together at all levels of the data chain. We need to develop systems whereby feedback on quality from wherever it comes can be documented and fed back. It is no use continually making corrections to the data down the line if those corrections never get back to the data curators and data custodians. It is also of little use if the information fed back goes nowhere and nothing is done with it. The TDWG Data Quality Interest Group is working on setting up standards and tools to help make this possible. We have developed a Framework for Data Quality, we have developed a set of core tests for data quality, and assertions for feeding information back to custodians and forward to users and is beginning a process to deal with vocabularies of value for biodiversity data.

Data Quality Associated with Handwritten Laboratory Test Requests: Classification and Frequency of Data-Entry Errors for Outpatient Serology Tests

2015 ◽  
Vol 44 (3) ◽  
pp. 7-12 ◽  
Author(s):  
Elia Vecellio ◽  
Michael W. Maley ◽  
George Toouli ◽  
Andrew Georgiou ◽  
Johanna Westbrook
Keyword(s):  
Laboratory Test ◽  
Data Quality ◽  
Data Entry

scholarly journals Implementation and Feasibility of Electronic Patient-Reported Outcome (ePRO) Data Entry in the PRAEGNANT Real-Time Advanced and Metastatic Breast Cancer Registry

2017 ◽  
Vol 77 (08) ◽  
pp. 870-878 ◽  
Author(s):  
Markus Wallwiener ◽  
Felix Heindl ◽  
Sara Brucker ◽  
Florin-Andrei Taran ◽  
Andreas Hartkopf ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Advanced Breast Cancer ◽  
Cancer Registry ◽  
Data Entry ◽  
Metastatic Breast ◽  
Advanced Breast ◽  
Patient Reported ◽  
Trial Staff ◽  
Breast Cancer Registry

Abstract Purpose Patient-reported outcomes (PROs) have been incorporated into clinical trials for many symptoms and medical conditions. A transition from paper-based capture of PROs to electronic PROs (ePROs) has recently started. This study reports on the feasibility of ePRO assessment in a prospective registry including molecular data for patients with advanced breast cancer. Methods As part of the PRAEGNANT network, patients were invited by clinical trial staff, physicians, and nurses to complete three standardized Internet-based questionnaires (EQ 5D 5 L, CES-D and IPAQ). Feasibility was assessed by the staff members who assigned the user accounts by the patients. The completeness of the questionnaires was also assessed. Results Fifteen of 17 patients who were asked agreed to participate to complete the PRO questionnaires (EQ-5D-5L and CES-D). However, the IPAQ (physical activity) questionnaire was only validly completed by 9 patients. Feasibility was ranked better by the physicians and dedicated clinical trial staff than by the nursing staff. Conclusions Incorporating ePRO questionnaires into an advanced breast cancer registry is feasible, and no major hurdles were reported. Involving stakeholders from the start, the application is tailored to the capacities and abilities of both patients and clinical staff. The patientsʼ compliance was better with some questionnaires, but others may present difficulties.

How Did a Multi-Institutional Trial Show Feasibility of Electronic Data Capture in Older Patients With Cancer? Results From a Multi-Institutional Qualitative Study (Alliance A171902)

2021 ◽  
pp. 442-449
Author(s):  
Nichole A. Martin ◽  
Elizabeth S. Harlos ◽  
Kathryn D. Cook ◽  
Jennifer M. O'Connor ◽  
Andrew Dodge ◽  
...  
Keyword(s):  
Older Patients ◽  
Electronic Devices ◽  
Data Entry ◽  
Data Capture ◽  
Data Availability ◽  
Electronic Data Capture ◽  
Wireless Internet ◽  
Electronic Data ◽  
Patients With Cancer ◽  
Patient Reported

PURPOSE New technology might pose problems for older patients with cancer. This study sought to understand how a trial in older patients with cancer (Alliance A171603) was successful in capturing electronic patient-reported data. METHODS Study personnel were invited via e-mail to participate in semistructured phone interviews, which were audio-recorded and qualitatively analyzed. RESULTS Twenty-four study personnel from the 10 sites were interviewed; three themes emerged. The first was that successful patient-reported electronic data capture shifted work toward patients and toward study personnel at the beginning of the study. One interviewee explained, “I mean it kind of lost all advantages…by being extremely laborious.” Study personnel described how they ensured electronic devices were charged, wireless internet access was up and running, and login codes were available. The second theme was related to the first and dealt with data filtering. Study personnel described high involvement in data gathering; for example, one interviewee described, “I answered on the iPad, whatever they said. They didn't even want to use it at all.” A third theme dealt with advantages of electronic data entry, such as prompt data availability at study completion. Surprisingly, some remarks described how electronic devices brought people together, “Some of the patients, you know, it just gave them a chance to kinda talk about, you know, what was going on.” CONCLUSION High rates of capture of patient-reported electronic data were viewed favorably but occurred in exchange for increased effort from patients and study personnel and in exchange for data that were not always patient-reported in the strictest sense.

Data Quality of Longitudinally Collected Patient-Reported Outcomes (PROs) after Thoracic Surgery: A Comparison of Paper- and Web-Based Assessments (Preprint)

2021 ◽  
Author(s):  
Hongfan Yu ◽  
Qingsong Yu ◽  
Yuxian Nie ◽  
Wei Xu ◽  
Yang Pu ◽  
...  
Keyword(s):  
Risk Factors ◽  
Thoracic Surgery ◽  
Data Quality ◽  
Severe Disease ◽  
Sampling Bias ◽  
Patient Reported Outcome ◽  
Web Based ◽  
Quality Of Life Scale ◽  
Patient Reported

BACKGROUND High-frequent patient-reported outcome (PRO) assessments are used to measure patients’ symptoms after surgery for surgical research; however, quality of those longitudinal PRO data has seldom been discussed. OBJECTIVE To describe errors, to identify factors influencing the data quality, and to profile error trajectories of data longitudinally collected via paper-and-pencil (P&P) or web-based-assessment (ePRO) after thoracic surgery. METHODS We extracted longitudinal PRO data from two prospective clinical studies. PROs were assessed by the MD Anderson Symptom Inventory Lung Cancer Module and single-item Quality of Life Scale before surgery and then daily after surgery until discharge or up to 14 days of hospitalization. Patient compliance and data error were identified and compared between P&P and ePRO. Generalized estimating equations models and two-piecewise models were used to describe trajectories of error incidence over time and to identify the risk factors. RESULTS Among 629 patients with at least 2 PRO assessments, 440 completed 3347 P&P assessments and 189 completed 1291 ePRO assessments. In total, 49.44% of patients had at least 1 error, including 1) missing items (64.69%), 2) modifications without signatures (27.99%), 3) selection of multiple options (3.02%), 4) missing patient signatures (2.54%), 5) missing researcher signatures (1.45%) and 6) missing completion dates (0.3%). ePRO patients had fewer errors than P&P patients (30.16% vs. 57.73%, p <0.0001). Compared with ePRO patients, those using P&P were older, less educated and sicker. Common risk factors of having errors were with a lower education level (P&P, OR=1.39, 95%CL=1.20-1.62, p<.0001; ePRO, OR=1.82, 95%CI=1.22-2.72, p=0.0032), treated in a provincial hospital (P&P, OR=3.34, 95%CI=2.10-5.33, p<.0001; ePRO, OR=4.73, 95%CI=2.18-10.25, p<.0001) and with severe disease (P&P, OR=1.63, 95%CI=1.33-1.99, p<.0001; ePRO, OR=2.70, 95%CI=1.53-4.75, p=0.0006). Errors peaked on postoperative day (POD) 1 for P&P, and on POD 2 for ePRO. CONCLUSIONS ePRO might be superior to P&P in terms of data quality. However, sampling bias needs to be considered for studies using longitudinal PROs as major outcomes.

scholarly journals Patient-Reported Outcomes Measures: An Introduction for Clinicians

2019 ◽  
Vol 4 (1) ◽  
pp. 8-15 ◽  
Author(s):  
Kathryn Yorkston ◽  
Carolyn Baylor
Keyword(s):  
Instrument Development ◽  
Patient Reported Outcomes ◽  
Outcome Measurement ◽  
Communication Disorders ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Patient Centered ◽  
Outcomes Measures ◽  
Patient Reported ◽  
Measurement Tools

Patient-reported outcome measures contain information that comes directly from the patient without interpretation by anyone else. These measures are an important part of a clinicians' arsenal of assessment approaches and are critical in the development of patient-centered approaches to intervention. In this introduction to patient-reported outcome measurement tools, a history is provided of this approach to measurement and its place within the context of clinical research and practice. The process of instrument development and application will be reviewed, along with examples of measurement tools from the field of neurological communication disorders. This introduction is supplemented by references that provide interested readers with more detailed information.

scholarly journals Benefits and Disadvantages of Electronic Patient-reported Outcome Measures: Systematic Review

10.2196/15588 ◽  
2020 ◽  
Vol 3 (1) ◽  
pp. e15588 ◽  
Author(s):  
Jill Meirte ◽  
Nick Hellemans ◽  
Mieke Anthonissen ◽  
Lenie Denteneer ◽  
Koen Maertens ◽  
...  
Keyword(s):  
Systematic Review ◽  
Data Quality ◽  
Outcome Measures ◽  
Symptom Management ◽  
Completion Time ◽  
Clinical Decision Making ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Health Technologies ◽  
Patient Reported

Background Patient-reported outcome measures (PROMs) are important in clinical practice and research. The growth of electronic health technologies provides unprecedented opportunities to systematically collect information via PROMs. Objective The aim of this study was to provide an objective and comprehensive overview of the benefits, barriers, and disadvantages of the digital collection of qualitative electronic patient-reported outcome measures (ePROMs). Methods We performed a systematic review of articles retrieved from PubMED and Web of Science. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed during all stages. The search strategy yielded a total of 2333 records, from which 32 met the predefined inclusion and exclusion criteria. The relevant ePROM-related information was extracted from each study. Results Results were clustered as benefits and disadvantages. Reported benefits of ePROMs were greater patient preference and acceptability, lower costs, similar or faster completion time, higher data quality and response rates, and facilitated symptom management and patient-clinician communication. Tablets were the most used ePROM modality (14/32, 44%), and, as a platform, Web-based systems were used the most (26/32, 81%). Potential disadvantages of ePROMs include privacy protection, a possible large initial financial investment, and exclusion of certain populations or the “digital divide.” Conclusions In conclusion, ePROMs offer many advantages over paper-based collection of patient-reported outcomes. Overall, ePROMs are preferred over paper-based methods, improve data quality, result in similar or faster completion time, decrease costs, and facilitate clinical decision making and symptom management. Disadvantages regarding ePROMs have been outlined, and suggestions are provided to overcome the barriers. We provide a path forward for researchers and clinicians interested in implementing ePROMs. Trial Registration PROSPERO CRD42018094795; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=94795

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