Most patients reported positively or neutrally of having served as controls in the trials within cohorts design

Objectives: To evaluate patients’ experience of having served as controls without a notification at the time of randomization in the context of the trial within cohorts (TwiCs) design. Methods: Patients were asked for their opinion on having served as controls in TwiCs, before and after having been provided the trial results. Patients had provided broad consent to randomization at cohort entry and had served as controls in one of two TwiCs (an exercise program after breast cancer treatment or radiotherapy dose-escalation for rectal cancer). Results: Two to 6 years after cohort entry, 15% (n = 16) of all patients remembered having provided broad consent to randomization. Before disclosure of trial results, 47% (n = 52) of patients thought positively, 45% (n = 50) neutrally, and 2% (n = 2) negatively of having served as controls in one of the two trials. Seventeen percent (n = 18) of patients were positive, 65% (n = 71) neutral, and 11% (n = 12) negative about not having been notified when serving as controls. The survey results were comparable after disclosure of trial results. Conclusions: These results support the use of the TwiCs design with the staged-informed consent procedure. Keeping patients engaged and aware of the consents provided might further improve patients’ experience of serving as controls in TwiCs

The National Dutch Breast Implant Registry: user-reported experiences and importance

Background: Robust (inter-)national breast implant registries are important. For some, registries are an administrative burden, for others they represent a solution for the discussions involving breast implants. The DBIR is one of the first national, opt-out, clinical registries of breast implants, providing information for clinical auditing and product recall. Four years after its introduction, it is time to address users’ comments in order to keep improving quality of registration, and patient safety. This study assesses users’ feedback focusing on importance of registration, logistics and user experience, and areas of improvement. Methods: In May 2018, a standardized online study–specific questionnaire was sent out to all members of the Netherlands Society of Plastic Surgery. Descriptive statistics were reported in absolute frequencies and/or percentages. Results: A total of 102 members responded to the questionnaire (response rate, 24.2%). Of all respondents, 97.1% were actively registering in DBIR. Respondents rated the importance of registration in DBIR as 8.1 out of 10 points. Ninety-one respondents suggested improvements for the DBIR. All comments were related to registration convenience and provision of automatically generated data. Conclusions: Respondents believe that registration is highly important and worth the administrative burden. However, we should collectively keep improving accuracy, usability and sustainability of breast

Oncology patients were found to understand and accept the Trials within Cohorts design

Background and Objective: The Trials within Cohorts design aims to reduce recruitment difficulties and disappointment bias in pragmatic trials. On cohort enrollment, broad informed consent for randomization is asked, after which cohort participants can be randomized to interventions or serve as controls without further notification. We evaluated patients' recollection, understanding, and acceptance of broad consent in a clinical oncology setting. Methods: We surveyed 610 patients with cancer participating in ongoing TwiCs; 482 patients (79%) responded, of which 312 patients shortly after cohort enrollment, 108 patients after randomization to an intervention (12-18 months after cohort enrollment), and a random sample of 62 cohort participants who had not been selected for interventions (1-6 months after cohort enrollment). Results: Shortly after providing cohort consent, 76% of patients (238/312) adequately remembered whether they had given broad consent for randomization. Of patients randomly offered interventions, 76% (82/108) remembered giving broad consent for randomization; 41% (44/108) understood they were randomly selected, 44% (48/108) were not interested in selection procedures, and 10% (11/108) did not understand selection was random. Among patients not selected for interventions, 42% (26/62) understood selection was random; 89% felt neutral regarding the scenario of "not being selected for an intervention while your data were being used in comparison with patients receiving interventions,"10% felt reassured (6/62) and 2% scared/insecure (2/62). Conclusion: Patients adequately remember giving broad consent for randomization shortly after cohort enrollment and after being offered an intervention, but recollection is lower in those never selected for interventions. Patients are acceptant of serving as control without further notifications. (c) 2020 The Author(s). Published by Elsevier Inc. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/)

The ethics of ‘Trials within Cohorts’ (TwiCs): 2nd international symposium - London, UK. 7-8 November 2016

On 7-8 th November 2016, 60 people with an interest in the ‘ Trials within Cohorts ’ (TwiCs) approach for randomised controlled trial design met in London. The purpose of this 2 nd TwiCs international symposium was to share perspectives and experiences on ethical aspects of the TwiCs design, discuss how TwiCs relate to the current ethical frame- work, provide a forum in which to discuss and debate ethical issues and identify future directions for conceptual and empirical research. The symposium was supported by the Wellcome Trust and the NIHR CLAHRC Yorkshire and Humber and organised by members of the TwiCs network led by Clare Relton and attended by people from the UK, the Netherlands, Norway, Canada and USA. The two-day sympo- sium enabled an international group to meet and share experiences of the TwiCs design (also known as the ‘ cohort multiple RCT design ’ ), and to discuss plans for future research. Over the two days, invited plenary talks were interspersed by discussions, posters and mini pre- sentations from bioethicists, triallists and health research regulators. Key findings of the symposium were: (1) It is possible to make a compelling case to ethics committees that TwiCs designs are ap- propriate and ethical; (2) The importance of wider considerations around the ethics of inefficient trial designs; and (3) some questions about the ethical requirements for content and timing of informed consent for a study using the TwiCs design need to be decided on a case-by-case basis

Automatic coronary artery calcium scoring on radiotherapy planning CT Scans of breast cancer patients: Reproducibility and association with traditional cardiovascular risk factors

Objectives Coronary artery calcium (CAC) is a strong and independent predictor of cardiovascular disease (CVD) risk. This study assesses reproducibility of automatic CAC scoring on radiotherapy planning computed tomography (CT) scans of breast cancer patients, and examines its association with traditional cardiovascular risk factors. Methods This study included 561 breast cancer patients undergoing radiotherapy between 2013 and 2015. CAC was automatically scored with an algorithm using supervised pattern recognition, expressed as Agatston scores and categorized into five categories (0, 1-10, 11-100, 101-400, >400). Reproducibility between automatic and manual expert scoring was assessed in 79 patients with automatically determined CAC above zero and 84 randomly selected patients without automatically determined CAC. Interscan reproducibility of automatic scoring was assessed in 294 patients having received two scans (82% on the same day). Association between CAC and CVD risk factors was assessed in 36 patients with CAC scores >100, 72 randomly selected patients with scores 1-100, and 72 randomly selected patients without CAC. Reliability was assessed with linearly weighted kappa and agreement with proportional agreement. Results 134 out of 561 (24%) patients had a CAC score above zero. Reliability of CVD risk categorization between automatic and manual scoring was 0.80 (95% Confidence Interval (CI): 0.74-0.87), and slightly higher for scans with breath-hold. Agreement was 0.79 (95% CI: 0.72-0.85). Interscan reliability was 0.61 (95% CI: 0.50-0.72) with an agreement of 0.84 (95% CI: 0.80-0.89). Ten out of 36 (27.8%) patients with CAC scores above 100 did not have other cardiovascular risk factors. Conclusions Automatic CAC scoring on radiotherapy planning CT scans is a reliable method to assess CVD risk based on Agatston scores. One in four breast cancer patients planned for radiotherapy have elevated CAC score. One in three patients with high CAC scores don't have other CVD risk factors and wouldn't have been identified as high risk

Fishing-Injury-Related Flexor Tenosynovitis of the Hand: A Case Report and Review

Hand infections occurring after fishing and other marine-related activities may involve uncommon bacteria that are not susceptible to the conventional or empiric antibiotic therapy used to treat soft tissue infections. Therefore appropriate treatment is often delayed and could lead to severe hand damage. An illustrative case of fishing-related injury leading to complicated tenosynovitis and horseshoe abscess caused by Mycobacterium marinum and its treatment course is outlined. Laceration of the skin during boating is fairly common. Because of the rarity of some of the bacteria, referrals to the appropriate specialist including hand surgeons and infectious disease specialists should occur in early stages. M. marinum infections should always be considered in injuries related to seawater and fishing as this may lead to early appropriate treatment and prevent severe damage

Patients’ and Healthcare Professionals’ Perspectives on Better Use of Patient-Reported Outcome Measures in Head and Neck Cancer

Objectives: Patients with head and neck cancer (HNC) are often highly affected by disease and treatment, resulting in impaired physical functioning and quality of life. Therefore, evaluation of patients’ psychosocial and functional outcomes can be facilitated by patient-reported outcome measures (PROMs). By providing the patients’ own perspectives, PROMs are crucial to improving patient-centered care. This study aimed to improve understanding of the perceived value of PROMs in HNC care and how to optimize their clinical value based on patients’ and multidisciplinary healthcare professionals’ (HCPs) perspectives.Methods: Population-based surveys among patients with HNC through their patient association and among HCPs nationwide through the Dutch Head and Neck Audit.Results: A total of 54 patients and 40 multidisciplinary HCPs from all 14 nationwide HNC centers (100%) responded. For patients, the most important element of patient-reported outcome collection systems was including a call to action for those with worse-than-average scores (28%), whereas clinicians found discussing scores during clinical visits the most important (39%). Although 16% of clinicians found short completion time the most important element, none of the patients selected completion time as most important. Additionally, 17% of patients stated completion time was not an issue, provided clinicians would use the outcomes for clinical purposes.Conclusions: Although patients and clinicians acknowledged the value of patient-reported outcomes, patients would like to be more involved in the clinical implications of their outcomes. Enhancing patients’ involvement by a call to action and providing feedback on their scores during outpatient clinic visits may improve the clinical value of PROMs.</p

Fishing-Injury-Related Flexor Tenosynovitis of the Hand: A Case Report and Review

Hand infections occurring after fishing and other marine-related activities may involve uncommon bacteria that are not susceptible to the conventional or empiric antibiotic therapy used to treat soft tissue infections. Therefore appropriate treatment is often delayed and could lead to severe hand damage. An illustrative case of fishing-related injury leading to complicated tenosynovitis and horseshoe abscess caused by Mycobacterium marinum and its treatment course is outlined. Laceration of the skin during boating is fairly common. Because of the rarity of some of the bacteria, referrals to the appropriate specialist including hand surgeons and infectious disease specialists should occur in early stages. M. marinum infections should always be considered in injuries related to seawater and fishing as this may lead to early appropriate treatment and prevent severe damage

Fishing-Injury-Related Flexor Tenosynovitis of the Hand: A Case Report and Review

Hand infections occurring after fishing and other marine-related activities may involve uncommon bacteria that are not susceptible to the conventional or empiric antibiotic therapy used to treat soft tissue infections. Therefore appropriate treatment is often delayed and could lead to severe hand damage. An illustrative case of fishing-related injury leading to complicated tenosynovitis and horseshoe abscess caused by Mycobacterium marinum and its treatment course is outlined. Laceration of the skin during boating is fairly common. Because of the rarity of some of the bacteria, referrals to the appropriate specialist including hand surgeons and infectious disease specialists should occur in early stages. M. marinum infections should always be considered in injuries related to seawater and fishing as this may lead to early appropriate treatment and prevent severe damage