scholarly journals iConsent an Electronic Consent Platform with the MS Register

2017 ◽  
Vol 1 (1) ◽  
Author(s):  
Rod Middleton ◽  
David Ford ◽  
Daniel Naeh
Keyword(s):  
Informed Consent ◽  
Large Scale ◽  
Routine Data ◽  
Ethics Committee ◽  
Ease Of Use ◽  
Consent Form ◽  
Observational Research ◽  
Number Of Patients ◽  
Patient Consent ◽  
Patient Reported

ABSTRACT ObjectivesThe UK MS Register is a large scale observational research platform, capturing data from patients, NHS and carries out linkage with routine data from the SAIL databank. We have 14,000 People with MS (PwMS) submitting Patient Reported Outcome Measures (PRoMS) quarterly and over 3000 patients consenting at NHS Sites around the UK A differentiating factor between Register and previous attempts to capture PRoMS and clinical data was the goal that it be paperless. One area, where paper had to be used, was obtaining informed consent. Clinical participants are consented using a triplicate consent form, one copy for the patient, one for medical notes and one for the Register It’s desirable for patients to be able to electronically consent, providing the following benefits: Tablet computers already in use to collect PRoMS Printing costs Participant expectations Improved content and user experience: improved feedback, of multimedia elements about informed consent Increased familiarity with tablets ApproachChanging consent methodology is complex, all documentation, processes and changes are reviewed by the ethics committee. A privacy protecting, secure software package (iConsent) was developed by modifying an existing package from Welsh Cancer Bank. The software is server based, running on a Secured MS SQLServer 2014 and developed in .net to iOS/Android tablets The practitioner taking consent explains the process, participants then see the approved documentation and materials. Finally they fill in their email address and name, and are presented with the consent form, the participant uses a stylus to sign. The practitioner then countersigns. Once completed a digitally signed, secure pdf is generated on the server. Links are sent by email to the participant, the Register and unit administrator. The pdf is functionally identical to the paper. ResultsThe South West Central Bristol ethics committee approved the software following guidance on security and documentation design. Staff were trained in system usage. A number of patients were successfully e-consented, Of note was a potential issue with some patients and how MS impacts their ability to sign without resting a hand on the screen. ConclusionPatients who have been e-consented have expressed satisfaction in the ease of use and security of the software. Patients being unable to rest their hands on the screen is being examined. Newer tablets can ignore inputs other than the stylus. The MS Register intends to use the software in additional centres to capture patient consent.

scholarly journals Mat Pilates and aquatic aerobic exercises for women with fibromyalgia: a protocol for a randomised controlled blind study

BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e022306 ◽  
Author(s):  
Hugo Jario de Almeida Silva ◽  
Caio Alano de Almeida Lins ◽  
Thaiza Teixeira Xavier Nobre ◽  
Vanessa Patrícia Soares de Sousa ◽  
Renata Trajano Jorge Caldas ◽  
...  
Keyword(s):  
Informed Consent ◽  
Visual Analogue Scale ◽  
Analogue Scale ◽  
Ethics Committee ◽  
Consent Form ◽  
Controlled Study ◽  
Human Beings ◽  
Informed Consent Form ◽  
Health Council ◽  
Randomised Controlled

IntroductionPhysical exercises have been recommended to improve the overall well-being of patients with fibromyalgia, with the main objective of repairing the effects of lack of physical conditioning and of improving the symptoms, especially pain and fatigue. Although widely recommended and widely known, few studies support the use of Pilates as an effective method in improving the symptoms of the disease, comparing it with other well-founded exercise modalities. This protocol was developed to describe the design of a randomised controlled study with a blind evaluator that evaluates the effectiveness of mat Pilates, comparing it with aquatic aerobic exercises, in improving pain in women with fibromyalgia.MethodsSixty women aged 18–60 years with a diagnosis of fibromyalgia, with a score of between 3 and 8 points on the Visual Analogue Scale for pain, and who sign the clear and informed consent form will be recruited according to the inclusion criteria. They will be randomised into one of the two intervention groups: (1) Pilates, to perform an exercise programme based on mat Pilates; and (2) aquatic exercise, to participate in a programme of aerobic exercises in the swimming pool. The protocol will correspond to 12 weeks of treatment, with both groups performing the exercises with supervision twice a week. The primary outcome will be pain (Visual Analogue Scale for pain). The secondary outcomes are to include impact related to the disease, functional capacity, sleep quality and overall quality of life. The evaluations will be performed at three points: at baseline and after 6 weeks and 12 weeks of treatment.Ethics and disseminationThis protocol has been approved by the Ethics Committee of FACISA/UFRN (number: 2.116.314). Data collection will begin after approval by the ethics committee. There will be prior contact with the women, at which time all the information about the study and the objectives will be presented, as well as resolution no 466/2012 of the National Health Council of Brazil for the year 2012, which provides guidelines and regulatory standards for research involving human beings. Participants must sign the informed consent form before the study begins.Trial registration numberNCT03149198.

User experience testing of my ePRO app in a diabetes mellitus type 2 focus group (Preprint)

2021 ◽  
Author(s):  
Christian Mueller ◽  
Isabel Schauerte ◽  
Stephan Martin
Keyword(s):  
Diabetes Mellitus ◽  
Informed Consent ◽  
Focus Group ◽  
User Experience ◽  
Patient Reported Outcomes ◽  
Consent Form ◽  
Qualitative And Quantitative ◽  
Informed Consent Form ◽  
Patient Reported

BACKGROUND Type 2 Diabetes Mellitus affects patients’ quality of life which easily can be assessed directly with patients using standardized and validated instruments. The my ePRO app was constructed as an innovative mobile application to collect patient-reported outcomes in an investigator free study (Digital collected Patient Reported Outcomes in a Diabetes population - DePRO study). OBJECTIVE We aimed to describe the qualitative and quantitative feedback received during user experience testing in a diabetes mellitus type 2 focus group. METHODS The DePRO user experience study was conducted in a qualitative and quantitative research design with focus group methodology to test the my ePRO app. Metformin containing drug taking patients aged 18 years or older completed a 37-item qualitative questionnaire as the quantitative 6 scales and 26 items containing User Experience Questionnaire (UEQ) in a single focus group interview. The qualitative interview required next to the completion of the entire study workflow feedback on user experience to 1) the download of the app, 2) scanning the 2D matrix code, 3) accepting the informed consent form, 4) completing the demographic questionnaire and the 3 PRO instruments EQ-5D-5L, SDSCA and DTSQ, 5). Furthermore, feedback on finding the informed consent form, the withdrawl button and data protection information within the app was requested. RESULTS Nine T2DM patients, 3 female and 6 male, aged 55-88 years were interviewed for 45 to 65 minutes. Patients missed lay language within the app, criticized the length of the patient information informed consent form, the completeness of health information which was requested, missed pictures of the drugs they scanned and judged the questions to income and education as too indiscreet. As positive feedback patient reported that everything was fine, the answering of the questions was self-explaining and could be read without glasses. The UEC scales (mean; variances) Perspicuity (0.722; 1.73), Efficiency (0.5; 0.89) and Novelty (0.25; 1.13) were rated neutral, Attractiveness (0.854: 0.63), Dependability (1.031; 0.1) and Stimulation (1.094; 0.39) represent a positive evaluation. CONCLUSIONS The qualitative feedback of T2DM patients increased the awareness to test study applications like the my ePRO app in an indication and age specific user group. User experiences were captured, analyzed and implemented in the final app version which was used to run the DePRO study. The quantitative feedback was compared to a benchmark data set, to which the my ePRO app means were below average in all scales. The user experience testing provided insight into usage, challenges and areas of improvement of my ePRO app in a type 2 Diabetes Mellitus focus group. Understanding the different views, experiences and expectations can lead to a better design of health apps and a successful study conduct. CLINICALTRIAL ClinicalTrials.gov: NCT04383041

scholarly journals CARPEM-LYNCH: a program linking hospital and NutriNet-Santé e-cohort data to test dynamic consent

2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
G Wendeu-Foyet ◽  
P Fassier ◽  
G Perrod ◽  
G Perkins ◽  
E Coffin ◽  
...  
Keyword(s):  
Informed Consent ◽  
Translational Research ◽  
Clinical Data ◽  
Large Scale ◽  
Health Impact ◽  
Nutritional Risk ◽  
Sustainable Solutions ◽  
Cohort Data ◽  
Dynamic Consent ◽  
Patient Consent

Abstract Background Technological innovations have contributed to rapid changes in translational research, allowing greater amounts of shared data on an unprecedented scale. However, methods for involving patients in research have not kept pace with changes in research capacity. Modern tools offering more flexibility in the management of patient consent are needed. The CARPEM-LYNCH program aims to explore the acceptance and feasibility of the concept of dynamic informed consent. It is a pilot program to test a research platform at the interface between hospital follow-up clinical data and data provided by patients through the NutriNet-Santé e-cohort platform. Methods Patients diagnosed with Lynch Syndrome followed at the European hospital Georges Pompidou (HEGP) are recruited and followed-up within the NutriNet-Santé online platform. In addition to generic NutriNet questionnaires (very detailed data on diet, physical activity, lifestyle, etc.), participants receive specific questionnaires related to their syndrome, perception of nutritional risk factors, and quality of life. Clinical data collected during standard hospital care will be linked to NutriNet data for participants who provide a dynamic consent. This dispositive will allow to investigate multiple dimensions of dietary behaviors and their health impact in these at-risk patients. Results The pilot phase has started. The first 20 patients have been included, showing good acceptance of the dynamic consent. Qualitative analysis of their responses is ongoing to optimize tools before large-scale deployment and extension to other hospital centers. Conclusions This experience of merging hospital and e-cohort data through dynamic consent to advance knowledge on health impact of diet and lifestyle in Lynch patients opens up a multitude of perspectives. Key messages Dynamic informed consent offers opportunities for data sharing between clinicians, researchers and patients with a promising impact on translational research. Dynamic informed consent can provide practical and sustainable solutions to the challenges of recruiting and retaining participants, managing consent and it can also be a source of economic efficiency.

scholarly journals Applying Best Practice to Converting Blood Collection Tube Suppliers: Overcoming Laboratory Supply Shortages

2021 ◽  
Vol 156 (Supplement_1) ◽  
pp. S148-S149
Author(s):  
P C Tsang ◽  
S F Absar ◽  
D Gingrich
Keyword(s):  
Large Scale ◽  
Best Practice ◽  
Cost Savings ◽  
Ease Of Use ◽  
Blood Collection ◽  
Testing Methodology ◽  
Patient Consent ◽  
Collection Tube ◽  
Allowable Error ◽  
Supply Costs

Abstract Introduction/Objective Changing blood tube suppliers is a complex process that requires systematic validation. It can serve to expand a laboratory’s options during a supply shortage, and can lead to cost savings. Just prior to the pandemic, our laboratory underwent a large-scale conversion of blood tube suppliers after successful validation of serum, plasma, and whole blood tubes for blood bank, chemistry, immunology, hematology, coagulation, molecular diagnostics, and flow cytometry. Methods/Case Report First, we designed a patient consent form for collecting extra blood samples. Per CLSI standards, validation of blood tubes is needed for each testing methodology but not for each analyte. Hence, we selected high-impact assays to represent each testing methodology used by our instrument platforms. We designed comparison studies to test the new blood tubes for result accuracy, precision and specimen stability that covered an assay’s reportable range. Allowable error limits were set based on Westgard and CAP guidelines. Spiked specimens were used when positive patient samples were not feasible. We also took the opportunity to optimize the blood tube sizes, e.g., converting the lavender-top tubes from 2 ml (vendor A) to 3 ml (vendor B). We then confirmed with our reference labs the acceptability of the new vendor’s products, and administered an electronic survey to solicit staff feedback. Finally, we coordinated supply chain, formulary changes and test catalog updates. Results (if a Case Study enter NA) Data analyses showed 100% acceptable performance of the new supplier’s blood tubes. The survey showed that our phlebotomists supported the new products, citing their ease of use and good vacuum. Our hematology technologists provided favorable feedback on the larger lavender-top tubes that reduced the number of insufficient samples. On the economic front, this supplier conversion has yielded a 26% cost savings. Conclusion To our knowledge, our study is the most comprehensive of all blood collection device comparison analyses published. Our validation strategies that were designed to comply with best practice standards have led to our confidence in the interchangeability of the new and old blood tube products. This initiative serves to elucidate a protocol to add vendor options that can be replicated by other laboratories to mitigate blood tube supply shortages and backorders. It has helped us control supply costs without compromising quality.

scholarly journals Participants' Comprehension of the Informed Consent in an Epidemiological Study on Dementia Prevalence: A Qualitative Study

2021 ◽  
Vol 12 ◽  
Author(s):  
Ilaria Falvo ◽  
Maddalena Fiordelli ◽  
Rebecca Amati ◽  
Aliaa Ibnidris ◽  
Emiliano Albanese ◽  
...  
Keyword(s):  
Informed Consent ◽  
Qualitative Study ◽  
Epidemiological Study ◽  
Large Scale ◽  
Consent Form ◽  
Dementia Prevalence ◽  
Informed Consent Form ◽  
Dementia Research ◽  
Age Appropriate ◽  
Informed Consent Document

Aim: In the absence of an effective treatment, informed participation in dementia research can hardly be underestimated. However, although informed consent is key in biomedical research, it may become a barrier to participation. Whether informed consent may cause confusion and contribute to unfair participant selection in dementia research is not known. In preparation of a future epidemiological study on the prevalence and impact of dementia in Switzerland, we aimed to conduct a qualitative study to explore participants' comprehension of the purpose of informed consent form and process shortly after participation in the pilot and validation study that preceded the large scale survey.Methods: We conducted a qualitative study with 22 participants of the validation phase of an epidemiological study on the prevalence and impact of dementia in Switzerland to capture their understanding of both the nature and the content of the informed consent form and process. Participants were older adults (65 years or more) eligible for a dementia epidemiological study and their informant (a person who could provide information on their health and cognition). None of the participants reported to be suffering from dementia at the time of the interview.Results: We found that participants held inaccurate and potentially trust-threatening beliefs regarding the scope of the informed consent. Participants identified contradictory contextual, formal and content needs that are difficult to be fulfilled, and misperceived the clinical and research settings in terms of informed consent procedures.Conclusions: Participants and their proxies should be informed about both the scope of the informed consent process, and the content of the informed consent document in a focused, age-appropriate manner, while dispelling confusion about the purpose of research.

scholarly journals Patient Experience in Home Respiratory Therapies: Where We Are and Where to Go

2019 ◽  
Vol 8 (4) ◽  
pp. 555 ◽  
Author(s):  
Cátia Caneiras ◽  
Cristina Jácome ◽  
Sagrario Mayoralas-Alises ◽  
José Ramon Calvo ◽  
João Almeida Fonseca ◽  
...  
Keyword(s):  
Clinical Research ◽  
Patient Experience ◽  
Clinical Care ◽  
Research Priorities ◽  
Specific Patient ◽  
Quality Healthcare ◽  
Body Of Knowledge ◽  
Number Of Patients ◽  
Patient Reported ◽  
System Sustainability

The increasing number of patients receiving home respiratory therapy (HRT) is imposing a major impact on routine clinical care and healthcare system sustainability. The current challenge is to continue to guarantee access to HRT while maintaining the quality of care. The patient experience is a cornerstone of high-quality healthcare and an emergent area of clinical research. This review approaches the assessment of the patient experience in the context of HRT while highlighting the European contribution to this body of knowledge. This review demonstrates that research in this area is still limited, with no example of a prescription model that incorporates the patient experience as an outcome and no specific patient-reported experience measures (PREMs) available. This work also shows that Europe is leading the research on HRT provision. The development of a specific PREM and the integration of PREMs into the assessment of prescription models should be clinical research priorities in the next several years.

scholarly journals Is Biofeedback through an Intra-Aural Device an Effective Method to Treat Bruxism? Case Series and Initial Experience

2020 ◽  
Vol 18 (1) ◽  
pp. 51
Author(s):  
Kira Pfeiffer ◽  
Thaqif El Khassawna ◽  
Deeksha Malhan ◽  
Christine Langer ◽  
Barbara Sommer ◽  
...  
Keyword(s):  
Clinical Evidence ◽  
Positive Impact ◽  
Case Series ◽  
Physiological Status ◽  
Initial Experience ◽  
Ear Canal ◽  
Number Of Patients ◽  
Patient Reported ◽  
Unpleasant Feeling ◽  
Ear Canals

Biofeedback was reported as an effective concept for bruxism treatment, through increasing patient’s awareness of the habit. During bruxing both ear canals become tighter, therefore, an in-ear device can provide biofeedback. The in-ear device is fitted to the ear canal in physiological status, during bruxing the ear-canal tightens resulting in stress on the canal walls and unpleasant feeling. Subsequently, patients stop their bruxing habit. The aim of this study is to provide first clinical evidence that in-ear devices have a positive impact on relieving bruxism in patients. Despite the low number of patients, this early study was designed as a controlled prospective study. The trial included seven female patients with a median age of 47.3 years (23–64 years). Only two patients implemented their devices for eight and seven months, respectively. One patient reported a relief in her symptoms, like headaches and pain intensity during the night, by 50% after three month and 80% after six months. Despite the limited number of participants, the study reflects a potential of Intra-aural devices as effective biofeedback devices in treating bruxism.

scholarly journals Durable Continuous-Flow Mechanical Circulatory Support: State of the Art

Hearts ◽  
2021 ◽  
Vol 2 (1) ◽  
pp. 127-138
Author(s):  
Antonio Loforte ◽  
Luca Botta ◽  
Silvia Boschi ◽  
Gregorio Gliozzi ◽  
Giulio Giovanni Cavalli ◽  
...  
Keyword(s):  
Heart Transplantation ◽  
Continuous Flow ◽  
Mechanical Circulatory Support ◽  
State Of The Art ◽  
Ease Of Use ◽  
Circulatory Support ◽  
Pulse Modulation ◽  
Ventricular Assist ◽  
Old Patients ◽  
Number Of Patients

Implantable mechanical circulatory support (MCS) systems for ventricular assist device (VAD) therapy have emerged as an important strategy due to a shortage of donor organs for heart transplantation. A growing number of patients are receiving permanent assist devices, while fewer are undergoing heart transplantation (Htx). Continuous-flow (CF) pumps, as devices that can be permanently implanted, show promise for the treatment of both young and old patients with heart failure (HF). Further improvement of these devices will decrease adverse events, enable pulse modulation of continuous blood flow, and improve automatic remote monitoring. Ease of use for patients could also be improved. We herein report on the current state of the art regarding implantable CF pumps for use as MCS systems in the treatment of advanced refractory HF.

scholarly journals P051 Symptoms of COVID-19 and anxiety levels in adult patients receiving b-and ts-DMARDS using an online reporting system

Rheumatology ◽  
2021 ◽  
Vol 60 (Supplement_1) ◽  
Author(s):  
May Nwe Lwin ◽  
Christopher Holroyd ◽  
Dinny Wallis ◽  
Saul Faust ◽  
Hans De Graaf ◽  
...  
Keyword(s):  
Lupus Erythematosus ◽  
Joint Pain ◽  
Connective Tissue Diseases ◽  
Anxiety Score ◽  
Online Portal ◽  
Inflammatory Conditions ◽  
Advanced Therapy ◽  
Number Of Patients ◽  
Patient Reported ◽  
Anxiety Levels

Abstract Background/Aims  The coronavirus disease-2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) is responsible for over 120,000 UK deaths. Those with chronic inflammatory conditions or receiving immunosuppressive medications are at higher risk of COVID-19 than the general population. As a result, rheumatology patients taking b- or ts-DMARDs were advised to shield. We planned to observe COVID-19 related symptoms and anxiety levels reported by rheumatology patients during the pandemic. Methods  From April 2020, 1,004 rheumatology patients from an advanced therapy database were invited to participate in the adult ImmunoCOVID study to collect daily symptoms (fever, cough, shortness of breath (SOB), sore throat, blocked nose, red-eye, headache, fatigue, joint pain, muscle pain, chills, nausea, diarrhoea and vomiting, loss of senses) and anxiety level using an online portal. Loss of senses were not recorded until week 7 as these were not officially recognized at the pandemic onset. Results  153 patients (rheumatoid arthritis, n = 75, psoriatic arthritis, n = 28, Axial spondyloarthropathy, n = 24, systemic lupus erythematosus, n = 2 and other connective tissue diseases, n = 24) consented and participated. By week 25, 142 patients remained. Among those, 36.57% (±6.09%) (average (±SD)) reported no symptoms over the 25 week period. The main symptoms reported were joint pain (mean=47.94%) followed by fatigue (27.17%). Few patients reported fever (0.94%), cough (8.34%), SOB (4.53%), or loss of senses (1.11%) with more symptoms reported during the first 8 weeks (April/May 2020) and another increase in September/October 2020. The anxiety score (pragmatic 10-point scale) mean (±SD) was 5.60 (±0.34) and remained elevated throughout the study though higher when lockdown began. Conclusion  During the first peak of SARS-CoV-2, the number of patients reporting COVID-19 symptoms appeared high and was associated with high levels of anxiety. As only a small number have been swab-tested, this may suggest that larger numbers of untested individuals have had COVID-19 with mild symptoms. Features of inflammatory rheumatic illnesses may mimic COVID-19 symptoms and create diagnostic difficulty (joint pain and fatigue) whilst anxiety may lead to over-reporting of symptoms in the absence of infection. The key symptoms of fever, cough and SOB were less common and may be most reliable. Disclosure  M. Lwin: None. C. Holroyd: None. D. Wallis: None. S. Faust: None. H. De Graaf: None. C.J. Edwards: Honoraria; Abbvie, Biogen, BMS, Celgene, Fresenius, GSK, Janssen, Lilly, Mundipharma, Pfizer, Roche, Sanofi, UCB. Member of speakers’ bureau; Abbvie, Biogen, BMS, Celgene, Janssen, Lilly, Sanofi, Pfizer, Roche. Grants/research support; Abbvie, Biogen, Pfizer. P051 Table 1:patient reported symptoms and anxiety score from immunoCOVID studyWeek & (number of participants)Fever (%)Cough (%)SOB (%)Joint pain (%)Fatigue (%)Loss of senses (%)No symptoms (%)Tested (n)Test positive (n)Anxiety score1 (26)3.857.6911.5446.1530.77NA30.77006.312 (42)2.3311.639.3052.3834.88NA28.57005.833 (69)1.4514.494.3552.1737.68NA23.19415.884 (92)1.0911.966.5254.3531.52NA27.17206.225 (110)0.0011.716.3145.9533.33NA30.00006.156 (108)0.0010.193.7050.0026.85NA34.26205.747 (119)0.8410.084.2049.5828.57NA34.45205.938 (120)0.007.505.0051.6734.170.8329.17305.629 (124)0.817.263.2352.4229.840.8136.29405.6410 (118)0.008.473.3948.3129.660.8534.75205.2811 (116)0.858.476.7849.1529.661.6933.62305.6512 (131)0.006.114.5856.4926.720.7635.11205.4513 (110)0.916.362.7350.0029.091.8242.73105.4414 (121)0.837.442.4847.1125.620.8339.67805.2815 (100)1.007.003.0046.0023.001.0041.00405.4816 (114)0.887.893.5139.4725.441.7542.98905.2717 (105)0.008.573.8144.7622.860.9543.81425.1018 (107)0.006.543.7443.9319.630.9343.93405.3019 (99)0.005.052.0240.4019.191.0145.45505.0820 (110)0.914.552.7350.9124.550.9139.09NA0Missing data21 (106)0.946.602.8350.0020.750.9439.62405.2822 (104)2.889.626.7349.0430.770.9635.58305.5023 (106)1.897.553.7742.4526.420.9436.79805.8924 (108)0.938.332.7844.4422.220.9341.67605.6125 (94)1.067.454.2641.4915.962.1344.68605.49Average0.948.344.5347.9427.171.1136.575.60SD0.972.312.254.395.350.426.090.34Weekly data are the average of daily reported symptoms and anxiety levels.

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