Feasibility of a healthcare system-based tetralogy of Fallot patient registry

2017 ◽  
Vol 28 (2) ◽  
pp. 269-275
Author(s):  
Audrey L. Khoury ◽  
Eric G. Jernigan ◽  
Muntasir H. Chowdhury ◽  
Laura R. Loehr ◽  
Jennifer S. Nelson
Keyword(s):  
Tetralogy Of Fallot ◽  
Patient Reported Outcomes ◽  
Online Survey ◽  
Data Entry ◽  
Epidemiological Studies ◽  
Adult Patients ◽  
Birth Mother ◽  
Information Privacy Concerns ◽  
Recruitment Challenges ◽  
Patient Reported

AbstractBackgroundPatient-reported outcomes and epidemiological studies in adults with tetralogy of Fallot are lacking. Recruitment and longitudinal follow-up investigation across institutions is particularly challenging. Objectives of this study were to assess the feasibility of recruiting adult patients with tetralogy of Fallot for a patient-reported outcomes study, describe challenges for recruitment, and create an interactive, online tetralogy of Fallot registry.MethodsAdult patients living with tetralogy of Fallot, aged 18–58 years, at the University of North Carolina were identified using diagnosis code query. A survey was designed to collect demographics, symptoms, history, and birth mother information. Recruitment was attempted by phone (Part I, n=20) or by email (Part II, n=20). Data analysis included thematic grouping of recruitment challenges and descriptive statistics. Feasibility threshold was 75% for recruitment and for data fields completed per patient.ResultsIn Part I, 60% (12/20) were successfully contacted and eight (40%) were enrolled. Demographics and birth mother information were obtained for all enrolled patients. In Part II, 70% (14/20) were successfully contacted; 30% (6/20) enrolled and completed all data fields linked to REDCap database; the median time for survey completion was 8 minutes. Half of the patients had cardiac operations/procedures performed at more than one hospital. Automatic electronic data entry from the online survey was uncomplicated.ConclusionsAlthough recruitment (54%) fell below our feasibility threshold, enrolled individuals were willing to complete phone or online surveys. Incorrect contact information, privacy concerns, and patient-reported time constraints were challenges for recruitment. Creating an online survey and linked database is technically feasible and efficient for patient-reported outcomes research.

The Development and Initial Findings of A Study of a Prospective Adult Research Cohort with Inflammatory Bowel Disease (SPARC IBD)

2021 ◽  
Author(s):  
Laura E Raffals ◽  
Sumona Saha ◽  
Meenakshi Bewtra ◽  
Cecile Norris ◽  
Angela Dobes ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Clinical Data ◽  
Bowel Disease ◽  
Patient Reported Outcomes ◽  
Data Entry ◽  
The United States ◽  
Predictors Of Response ◽  
Patient Reported ◽  
Inflammatory Bowel ◽  
Reported Data

Abstract Background Clinical and molecular subcategories of inflammatory bowel disease (IBD) are needed to discover mechanisms of disease and predictors of response and disease relapse. We aimed to develop a study of a prospective adult research cohort with IBD (SPARC IBD) including longitudinal clinical and patient-reported data and biosamples. Methods We established a cohort of adults with IBD from a geographically diverse sample of patients across the United States with standardized data and biosample collection methods and sample processing techniques. At enrollment and at time of lower endoscopy, patient-reported outcomes (PRO), clinical data, and endoscopy scoring indices are captured. Patient-reported outcomes are collected quarterly. The quality of clinical data entry after the first year of the study was assessed. Results Through January 2020, 3029 patients were enrolled in SPARC, of whom 66.1% have Crohn’s disease (CD), 32.2% have ulcerative colitis (UC), and 1.7% have IBD-unclassified. Among patients enrolled, 990 underwent colonoscopy. Remission rates were 63.9% in the CD group and 80.6% in the UC group. In the quality study of the cohort, there was 96% agreement on year of diagnosis and 97% agreement on IBD subtype. There was 91% overall agreement describing UC extent as left-sided vs extensive or pancolitis. The overall agreement for CD behavior was 83%. Conclusion The SPARC IBD is an ongoing large prospective cohort with longitudinal standardized collection of clinical data, biosamples, and PROs representing a unique resource aimed to drive discovery of clinical and molecular markers that will meet the needs of precision medicine in IBD.

scholarly journals Non- or Minimally Displaced Distal Radial Fractures in Adult Patients: Three Weeks versus Five Weeks of Cast Immobilization—A Randomized Controlled Trial

2018 ◽  
Vol 08 (01) ◽  
pp. 043-048 ◽  
Author(s):  
A. Bentohami ◽  
J. Vermeulen ◽  
N. L. Sosef ◽  
N. de Korte ◽  
T. S. Bijlsma ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Patient Reported Outcomes ◽  
Controlled Trial ◽  
Adult Patients ◽  
Cast Immobilization ◽  
Distal Radial Fractures ◽  
Randomized Controlled ◽  
Patient Reported ◽  
Secondary Displacement

Background Patients with non- or minimally displaced distal radial fractures, that do not need repositioning, are mostly treated by a short-arm cast for a period of 4 to 6 weeks. A shorter period of immobilization may lead to a better functional outcome. Purpose We conducted a randomized controlled trial to evaluate whether the duration of cast immobilization for patients with non- or minimally displaced distal radial fractures can be safely shortened toward 3 weeks. Materials and Methods The primary outcomes were patient-reported outcomes measured by the Patient-Related Wrist Evaluation (PRWE) and Quick Disability of Arm, Shoulder and Hand (QuickDASH) score after 1-year follow-up. Secondary outcome measures were: PRWE and QuickDASH earlier in follow-up, pain (Visual Analog Scale), and complications like secondary displacement. Results Seventy-two patients (male/female, 23/49; median age, 55 years) were included and randomized. Sixty-five patients completed the 1-year follow-up. After 1-year follow up, patients in the 3 weeks immobilization group had significantly better PRWE (5.0 vs. 8.8 points, p = 0.045) and QuickDASH scores (0.0 vs. 12.5, p = 0.026). Secondary displacement occurred once in each group. Pain did not differ between groups (p = 0.46). Conclusion Shortening the period of immobilization in adult patients with a non- or minimally displaced distal radial fractures seems to lead to equal patient-reported outcomes for both the cast immobilization groups. Also, there are no negative side effects of a shorter period of cast immobilization. Therefore, we recommend a period of 3 weeks of immobilization in patients with distal radial fractures that do not need repositioning.

scholarly journals Issues and Challenges With Integrating Patient-Reported Outcomes in Clinical Trials Supported by the National Cancer Institute–Sponsored Clinical Trials Networks

2007 ◽  
Vol 25 (32) ◽  
pp. 5051-5057 ◽  
Author(s):  
Deborah Watkins Bruner ◽  
Charlene J. Bryan ◽  
Neil Aaronson ◽  
C. Craig Blackmore ◽  
Michael Brundage ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Patient Reported Outcomes ◽  
Online Survey ◽  
Cancer Control ◽  
The United States ◽  
Cancer Clinical Trials ◽  
Cooperative Group ◽  
Cooperative Groups ◽  
End Points ◽  
Patient Reported

Purpose The objective of this report is to provide a historical overview of and the issues and challenges inherent in the incorporation of patient-reported outcomes (PROs) into multinational cancer clinical trials in the cancer cooperative groups. Methods An online survey of 12 cancer cooperative groups from the United States, Canada, and Europe was conducted between June and August of 2006. Each of the cooperative groups designated one respondent, who was a member of one of the PRO committees within the cooperative group. Results There was a 100% response rate, and all of the cancer clinical trial cooperative groups reported conducting PRO research. PRO research has been conducted in the cancer cooperative groups for an average of 15 years (range, 6 to 30 years), and all groups had multidisciplinary committees focused on the design of PRO end points and the choice of appropriate PRO measures for cancer clinical trials. The cooperative groups reported that 5% to 50% of cancer treatment trials and an estimated 50% to 75% of cancer control trials contained PRO primary and secondary end points. There was considerable heterogeneity among the cooperative groups with respect to the formal and informal policies and procedures or cooperative group culture towards PROs, investigator training/mentorship, and resource availability for the measurement and conduct of PRO research within the individual cooperatives. Conclusion The challenges faced by the cooperative groups to the incorporation of PROs into cancer clinical trials are varied. Some common opportunities for improvement include the adoption of standardized training/mentorship mechanisms for investigators for the conduct of PRO assessments and data collection and the development of minimal criteria for PRO measure acceptability. A positive cultural shift has occurred in most of the cooperative groups related to the incorporation of PROs in clinical trials; however, financial and other resource barriers remain and need to be addressed.

scholarly journals Continuous digital collection of patient-reported outcomes during inpatient treatment for affective disorders - implementation and feasibility

2020 ◽  
Author(s):  
Maike Richter ◽  
Michael Storck ◽  
Rogerio Blitz ◽  
Janik Goltermann ◽  
Juliana Seipp ◽  
...  
Keyword(s):  
Affective Disorders ◽  
Inpatient Treatment ◽  
Patient Reported Outcomes ◽  
Data Entry ◽  
Machine Learning Algorithms ◽  
Individual Risk ◽  
Depression Severity ◽  
Patient Reported ◽  
Longitudinal Data Collection ◽  
Digital Collection

Multivariate predictive models have revealed promising results for the individual prediction of treatment response, relapse risk as well as for the differential diagnosis in affective disorders. Yet, in order to translate personalized predictive modelling from the research context to psychiatric clinical routine, standardized collection of information of sufficient detail and temporal resolution in day-to-day clinical care is needed, based on which machine learning algorithms can be trained. Digital collection of patient-reported outcomes (PROs) is a time- and cost-efficient approach to gain such data throughout the treatment course. However, it remains unclear whether patients with severe affective disorders are willing and able to participate in such efforts, whether the feasibility of such systems might vary depending on individual patient characteristics and if digitally acquired patient-reported outcomes are of sufficient diagnostic validity. To address these questions, we implemented a system for continuous digital collection of patient-reported outcomes via tablet computers throughout inpatient treatment for affective disorders at the Department of Psychiatry at the University of Muenster. 364 affective disorder patients were approached, 66.5% of which could be recruited to participate in the study. An average of four assessments were completed during the treatment course, none of the participants dropped out of the study prematurely. 89.3% of participants did not require additional support during data entry. Need of support with tablet handling and slower data entry pace was predicted by older age, whereas depression severity at baseline did not influence these measures. Patient-reported outcomes of depression severity showed high agreement with standardized external assessments by a clinical interviewer. Our results indicate that continuous digital collection of patient-reported outcomes is a feasible, accessible and valid method for longitudinal data collection in psychiatric routine, which will eventually facilitate the identification of individual risk and resilience factors for affective disorders and pave the way towards personalized psychiatric care.

scholarly journals Acceptance, Usage, and Barriers of Electronic Patient-Reported Outcomes Among German Rheumatologists: Survey Study (Preprint)

2020 ◽  
Author(s):  
Martin Krusche ◽  
Philipp Klemm ◽  
Manuel Grahammer ◽  
Johanna Mucke ◽  
Diana Vossen ◽  
...  
Keyword(s):  
Patient Reported Outcomes ◽  
Online Survey ◽  
Data Transfer ◽  
German Society ◽  
Survey Study ◽  
Routine Practice ◽  
Full Potential ◽  
Patient Centered ◽  
Seamless Integration ◽  
Patient Reported

BACKGROUND The use of patient-reported outcomes (PROs) allows for patient-centered, measurable, and transparent care. Electronic PROs (ePROs) have many benefits and hold great potential to improve current usage of PROs, yet limited evidence exists regarding their acceptance, usage, and barriers among rheumatologists. OBJECTIVE This study aims to evaluate the current level of acceptance, usage, and barriers among German rheumatologists regarding the use of ePROs. The importance of different ePRO features for rheumatologists was investigated. Additionally, the most frequently used PROs for patients with rheumatoid arthritis (RA) were identified. METHODS Data were collected via an online survey consisting of 18 questions. The survey was completed by members of the Working Group Young Rheumatology of the German Society for Rheumatology (Arbeitsgemeinschaft Junge Rheumatologie der Deutschen Gesellschaft für Rheumatologie [DGRh]) at the 2019 annual DGRh conference. Only members currently working in clinical adult rheumatology were eligible to complete the survey. RESULTS A total of 119 rheumatologists completed the survey, of which 107 (89.9%) reported collecting PROs in routine practice and 28 (25.5%) already used ePROs. Additionally, 44% (43/97) were planning to switch to ePROs in the near future. The most commonly cited reason for not switching was the unawareness of suitable software solutions. Respondents were asked to rate the features of ePROs on a scale of 0 to 100 (0=unimportant, 100=important). The most important features were automatic score calculation and display (mean 77.50) and simple data transfer to medical reports (mean 76.90). When asked about PROs in RA, the respondents listed pain, morning stiffness, and patient global assessment as the most frequently used PROs. CONCLUSIONS The potential of ePROs is widely seen and there is great interest in them. Despite this, only a minority of physicians use ePROs, and the main reason for not implementing them was cited as the unawareness of suitable software solutions. Developers, patients, and rheumatologists should work closely together to help realize the full potential of ePROs and ensure a seamless integration into clinical practice.

Using mobile app technology for patient data capture and implementation.

2012 ◽  
Vol 30 (34_suppl) ◽  
pp. 317-317
Author(s):  
Steven J. Nurkin ◽  
Stephen B. Edge ◽  
Venkata R. Kakarla ◽  
Nikhil I. Khushalani
Keyword(s):  
Cancer Registry ◽  
Patient Reported Outcomes ◽  
Breast Surgery ◽  
Point Of Care ◽  
Data Entry ◽  
Patient Data ◽  
Care Plan ◽  
Patient Treatment ◽  
Patient Reported ◽  
Treatment Summary

317 Background: Mobile application technology has quickly become an integral part of clinical cancer care. While this technology is most commonly used as a point of care reference or educational tool, it may also be an effective method to capture patient data. The purpose of this project was to create a mobile solution for fast, point-of-care data capture and implementation, patient reported outcomes, to generate a patient treatment summary and provide data for cancer registry and clinical trials. Methods: Using the “MedDB app” (Bitwise Analytics) on an iPad2 (Apple) device, an application was developed to collect patient data following breast surgery for cancer. Collected data included elements required for pathologic staging using the American Joint Committee on Cancer TNM system (7th Edition) with the application deriving pathologic TNM and Stage Group. In addition, the type of breast surgery, lymph node surgery, and the expected next steps in treatment are coded for collection. Data are entered into the App in the clinic and transferred using a blinded code number to a web-based database. This database is then used to generate a patient surgical treatment summary and care plan, and is available for uploading into a research database. We then developed an individual patient App for their own personal mobile device. The purpose was to collect patient reported outcomes through their adjuvant care and surviorship. Results: The initial pilot included data entry on 20 breast cancer patients who had surgery prior to adjuvant therapy. The time to complete data entry was less than 60 seconds per case. Conclusions: Mobile communication devices are increasingly becoming key tools for clinicians. They are primarily used to search for medical resource information and the review of medical records. This pilot demonstrates the potential for use of mobile computer devices for collecting key data for clinical trials, the cancer registry, generating a patient treatment summary and care plan at the point of service as well as patient reported outcomes through personalized patient apps. Future development will include studies of integration with the electronic health record, the cancer registry systems, and expansion to a complete survivorship care plan system.

scholarly journals Oncology patient preferences in reporting on symptoms

2020 ◽  
Vol 7 (1) ◽  
pp. 11
Author(s):  
Alyssa L. Peechatka ◽  
Millie Gerzon ◽  
Jenny J. Ly ◽  
Susan M. Dallabrida
Keyword(s):  
Clinical Trials ◽  
Cancer Diagnosis ◽  
Patient Reported Outcomes ◽  
Online Survey ◽  
Data Capture ◽  
Oncology Patient ◽  
Patient Reported ◽  
Oncology Clinical Trials ◽  
Preliminary Study ◽  
Patient Burden

<p><strong>Background:</strong> Collecting patient reported outcomes (PROs) in oncology clinical trials is becoming increasingly important. However, there is limited consensus on the most appropriate frequency of PRO administration in oncology trials.  The aim of this preliminary study is to examine the perspective of participants with a cancer diagnosis on the importance of completing PROs and to identify at what frequency participants prefer to report on their cancer-related symptoms.</p><p class="abstract"><strong>Methods:</strong> 166 participants with a self-reported cancer diagnosis completed a multiple-choice online survey regarding perceptions of symptom importance and reporting preferences.</p><p class="abstract"><strong>Results:</strong> When asked about the benefit of reporting oncology-related symptoms daily, 44% of participants indicated there would be “very much” a benefit, 29% indicated there would be “quite a bit” of benefit, and 17% indicated there would be “somewhat” of a benefit. When asked about how frequently they would prefer to report symptoms, 41% of participants preferred “as they occur,” 36% preferred “once a day,” 18% preferred “once a week,” 4% preferred “twice a day,” and 1% preferred “every 4 hours”.</p><p class="abstract"><strong>Conclusions: </strong>PROs in oncology clinical research are most often collected at weekly, monthly, or longer intervals; however, meaningful fluctuations in cancer-related symptoms can occur more frequently. While concerns regarding patient burden are often raised to support infrequent reporting, these data suggest that participants would like to report symptoms with greater frequency, as episodic and daily reporting options were most popular. Based on these data, more frequent PRO data capture is not only feasible but perceived as important by individuals with cancer.</p>

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