MP12-16 THE IMPACT OF A DEDICATED DEPARTMENT CLINICAL RESEARCH TEAM AND FORMAL RESIDENCY RESEARCH CURRICULUM

ObjectiveTo explore the impact of the death of a patient in the haemodialysis unit on fellow patients.MethodsWe interviewed patients on dialysis in a tertiary dialysis centre using semistructured interviews. We purposively sampled patients who had experienced the death of a fellow patient. After interviews were transcribed, they were thematically analysed by independent members of the research team using inductive analysis. Input from the team during analysis ensured the rigour and quality of the findings.Results10 participants completed the interviews (6 females and 4 males with an age range of 42–88 years). The four core themes that emerged from the interviews included: (1) patients’ relationship to haemodialysis, (2) how patients define the haemodialysis community, (3) patients’ views on death and bereavement and (4) patients’ expectations around death in the dialysis community. Patients noticed avoidance behaviour by staff in relation to discussing death in the unit and would prefer a culture of open acknowledgement.ConclusionStaff acknowledgement of death is of central importance to patients on haemodialysis who feel that the staff are part of their community. This should guide the development of appropriate bereavement support services and a framework that promotes the provision of guidance for staff and patients in this unique clinical setting. However, the authors acknowledge the homogenous sample recruited in a single setting may limit the transferability of the study. Further work is needed to understand diverse patient and nurse experiences and perceptions when sharing the knowledge of a patient’s death and how they react to loss.

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

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.2415 ◽

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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MCR: Open-Source Software to Automate Compilation of Health Study Report-Back

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18116104 ◽

2021 ◽

Vol 18 (11) ◽

pp. 6104

Author(s):

Erin Polka ◽

Ellen Childs ◽

Alexa Friedman ◽

Kathryn S. Tomsho ◽

Birgit Claus Henn ◽

...

Keyword(s):

Quality Control ◽

Open Source ◽

Open Source Software ◽

Research Team ◽

Self Determination ◽

Health Study ◽

Equitable Access ◽

Team Members ◽

Study Participants ◽

The Impact

Sharing individualized results with health study participants, a practice we and others refer to as “report-back,” ensures participant access to exposure and health information and may promote health equity. However, the practice of report-back and the content shared is often limited by the time-intensive process of personalizing reports. Software tools that automate creation of individualized reports have been built for specific studies, but are largely not open-source or broadly modifiable. We created an open-source and generalizable tool, called the Macro for the Compilation of Report-backs (MCR), to automate compilation of health study reports. We piloted MCR in two environmental exposure studies in Massachusetts, USA, and interviewed research team members (n = 7) about the impact of MCR on the report-back process. Researchers using MCR created more detailed reports than during manual report-back, including more individualized numerical, text, and graphical results. Using MCR, researchers saved time producing draft and final reports. Researchers also reported feeling more creative in the design process and more confident in report-back quality control. While MCR does not expedite the entire report-back process, we hope that this open-source tool reduces the barriers to personalizing health study reports, promotes more equitable access to individualized data, and advances self-determination among participants.

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Raising standards in clinical research – The impact of the ECRIN data centre certification programme, 2011–2016

Contemporary Clinical Trials Communications ◽

10.1016/j.conctc.2017.02.005 ◽

2017 ◽

Vol 5 ◽

pp. 153-159 ◽

Cited By ~ 5

Author(s):

C. Ohmann ◽

S. Canham ◽

J. Demotes ◽

G. Chêne ◽

J. Lauritsen ◽

...

Keyword(s):

Clinical Research ◽

Data Centre ◽

Certification Programme ◽

The Impact

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Cancer patients’ awareness about clinical research in the era of social media and “fake news”: Preliminary results from ELPIS Study.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.e24121 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. e24121-e24121

Author(s):

Celeste Cagnazzo ◽

Veronica Franchina ◽

Giuseppe Toscano ◽

Franca Fagioli ◽

Tindara Franchina ◽

...

Keyword(s):

Informed Consent ◽

Clinical Research ◽

Cancer Patients ◽

Experimental Therapy ◽

Average Score ◽

Trial Participation ◽

Primary Role ◽

Fake News ◽

Patient Awareness ◽

The Impact

e24121 Background: Barriers for low recruitment in clinical trials have been classified based on three main sources: physician, patient, system. A primary role is played by a low patient awareness, which often leads to a lack of confidence in science and a substantial inability to estimate the benefits deriving from trial participation, aggravated by the spread of fake news. A prospective observational study was conducted to investigate the views of cancer patients on aspects of clinical research, their expectations, the level of comprehensibility of informed consent and the impact of the fake news phenomenon. Methods: From January 2018, after Ethics Committees approval, the ELPIS study was initiated in 9 Italian Medical Oncology Units. After signing the informed consent, patients were asked to complete a questionnaire, consisting of a set of multiple choice and Likert-score questions. Results: As of January 2021, 115 patients were enrolled, with a balanced sex distribution and a prevalence of subjects older than 55-years (79.8%). Regarding the previous knowledge about clinical research, the average score was 3.9 (range 1-5). The vast majority of respondents (91.3%) had already started experimental therapy and many of them constantly used internet (65.2%) and social networks (34.8%). More than half (53.9%) stated the interview with the physician was sufficient for a full understanding of informed consent. In case of doubt, the majority seeked support in the clinician (39.1%) while very few (1.7%) relied on the web. The average score attributed to doctor-patient relationship was equal to 8.89 (range 1-10). Respondents were quite confident in their ability to independently search for information on their disease, discriminate fake news and identify reliable sites (average score 3.26, 3.27, 3.09 respectively, over a range of 1-5). The scores related to the presumed ability to understand the results of a clinical study and to actively collaborate to produce research were high (average score 4.72 and 4.39 over a range of 1-5). Conclusions: Preliminary data from our research show a good level of patient awareness and a fine ability to understand information, discerning real from fake news. Continuing and implementing the training initiatives of the population in the health sector will certainly contribute to further improvement, hopefully obtaining an even greater involvement of patients in the early phases of research.

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Abstract TP292: Effect of Improved Management Strategies on Study Retention Rates

Stroke ◽

10.1161/str.51.suppl_1.tp292 ◽

2020 ◽

Vol 51 (Suppl_1) ◽

Author(s):

Michael Dela Cruz ◽

Kinga Aitken ◽

Ka-Ho Wong ◽

Theodore Rock ◽

Jennifer J Majersik

Keyword(s):

Clinical Research ◽

Research Team ◽

Retention Rate ◽

Management Strategies ◽

Retention Rates ◽

Stroke Patients ◽

Trial Duration ◽

Implementation Period ◽

Stroke Center ◽

Stroke Trial

Introduction: Average national dropout rates of participants enrolled in a research trial are reported to be 30%. Factors contributing to loss of stroke patient retention include the lack of understanding of study expectations, lack of relationship building between patient and clinical research team, and inefficient management processes. There has been little research into interventions to improve retention. Focusing on these 3 factors may increase the likelihood of stroke patients adhering to and completing participation in stroke trials. The University of Utah Stroke Center became a StrokeNet regional coordinating center in October 2013. As study trials increased, we recognized the need to implement new trial management strategies and did so in January 2016. Methods: Stroke trial metrics were compared between the pre-implementation period (7/1/2012 - 12/31/2015) and a post-implementation period (1/7/2016 - 7/1/2019). The size of clinical research team personnel remained the same across the two periods: 4 coordinators and 9 physicians. Standardization of enrollment processes in stroke trials occurred during the post-implementation period. Three key aspects addressed in the post-implementation period were building rapport, setting realistic expectations, and properly educating patient and family members. The clinical research team incorporated these factors when approaching patients regardless of type of stroke trial (acute, subacute, or observational). Results: During the pre-implementation period, the Stroke Center research team managed 8 stroke studies with 52 patients consented with average trial duration of 23 months (SD); in the post-implementation period, there were 15 studies with 99 patients consented, with average trial duration of 22 months (SD). Retention improved after the intervention from a mean (SD) retention rate of 79.5 (29.7) %. to 90.8 (17.2) %. Although this difference was not significant, it represented meaningful change to the research staff and helped us achieve StrokeNet retention goals. Conclusion: Implementation of effective management strategies leads to higher retention rates of stroke patients despite no change in the size of the clinical research team.

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