Perspectives on involvement in the peer-review process : surveys of patient and public reviewers at two journals

Objective In 2014/2015, The BMJ and Research Involvement and Engagement (RIE) became the first journals to routinely include patients and the public in the peer review process of journal articles. This survey explores the perspectives and early experiences of these reviewers. Design A cross-sectional survey. Setting and participants Patient and public reviewers for The BMJ and RIE who have been invited to review. Results The response rate was 69% (157/227) for those who had previously reviewed and 31% (67/217) for those who had not yet reviewed. Reviewers described being motivated to review by the opportunity to include the patient voice in the research process, influence the quality of the biomedical literature and ensure it meets the needs of patients. Of the 157 who had reviewed, 127 (81%) would recommend being a reviewer to other patients and carers. 144 (92%) thought more journals should adopt patient and public review. Few reviewers (16/224, 7%) reported concerns about doing open review. Annual acknowledgement on the journals’ websites was welcomed as was free access to journal information. Participants were keen to have access to more online resources and training to improve their reviewing skills. Suggestions on how to improve the reviewing experience included: allowing more time to review; better and more frequent communication; a more user-friendly process; improving guidance on how to review including videos; improving the matching of papers to reviewers’ experience; providing more varied sample reviews and brief feedback on the usefulness of reviews; developing a sense of community among reviewers; and publicising of the contribution that patient and public review brings. Conclusions Patient and public reviewers shared practical ideas to improve the reviewing experience and these will be reviewed to enhance the guidance and support given to them

Trial Forge Guidance 1 : what is a Study Within A Trial (SWAT)?

Randomised trials are a central component of all evidence-informed health care systems and the evidence coming from them helps to support health care users, health professionals and others to make more informed decisions about treatment. The evidence available to trialists to support decisions on design, conduct and reporting of randomised trials is, however, sparse. Trial Forge is an initiative that aims to increase the evidence base for trial decision-making and in doing so, to improve trial efficiency.One way to fill gaps in evidence is to run Studies Within A Trial, or SWATs. This guidance document provides a brief definition of SWATs, an explanation of why they are important and some practical 'top tips' that come from existing experience of doing SWATs. We hope the guidance will be useful to trialists, methodologists, funders, approvals agencies and others in making clear what a SWAT is, as well as what is involved in doing one

International Survey to Establish Prioritized Outcomes for Trials in People With Coronavirus Disease 2019.

OBJECTIVES: There are over 4,000 trials conducted in people with coronavirus disease 2019. However, the variability of outcomes and the omission of patient-centered outcomes may diminish the impact of these trials on decision-making. The aim of this study was to generate a consensus-based, prioritized list of outcomes for coronavirus disease 2019 trials. DESIGN: In an online survey conducted in English, Chinese, Italian, Portuguese, and Spanish languages, adults with coronavirus disease 2019, their family members, health professionals, and the general public rated the importance of outcomes using a 9-point Likert scale (7-9, critical importance) and completed a Best-Worst Scale to estimate relative importance. Participant comments were analyzed thematically. SETTING: International. SUBJECTS: Adults 18 years old and over with confirmed or suspected coronavirus disease 2019, their family members, members of the general public, and health professionals (including clinicians, policy makers, regulators, funders, and researchers). INTERVENTIONS: None. MEASUREMENTS: None. MAIN RESULTS: In total, 9,289 participants from 111 countries (776 people with coronavirus disease 2019 or family members, 4,882 health professionals, and 3,631 members of the public) completed the survey. The four outcomes of highest priority for all three groups were: mortality, respiratory failure, pneumonia, and organ failure. Lung function, lung scarring, sepsis, shortness of breath, and oxygen level in the blood were common to the top 10 outcomes across all three groups (mean > 7.5, median ≥ 8, and > 70% of respondents rated the outcome as critically important). Patients/family members rated fatigue, anxiety, chest pain, muscle pain, gastrointestinal problems, and cardiovascular disease higher than health professionals. Four themes underpinned prioritization: fear of life-threatening, debilitating, and permanent consequences; addressing knowledge gaps; enabling preparedness and planning; and tolerable or infrequent outcomes. CONCLUSIONS: Life-threatening respiratory and other organ outcomes were consistently highly prioritized by all stakeholder groups. Patients/family members gave higher priority to many patient-reported outcomes compared with health professionals.The project is funded by the Flinders University and the National COVID-19 Clinical Evidence Taskforce, convened by the Australian Living Evidence Consortium, hosted by Cochrane Australia, School of Public Health and Preventive Medicine, Monash University supported by the Australian Government, Victorian Department of Health and Human Services, Ian Potter Foundation, Walter Cottman Endowment Fund (managed by Equity Trustees) and the Lord Mayor's Charitable Foundation). AT is supported by The University of Sydney Robinson Fellowship. ACM is supported by a Clinical Research Career Development Fellowship from the Wellcome Trust (WT 2055214/Z/16/Z

Core Outcomes Set for Trials in People With Coronavirus Disease 2019.

OBJECTIVES: The outcomes reported in trials in coronavirus disease 2019 are extremely heterogeneous and of uncertain patient relevance, limiting their applicability for clinical decision-making. The aim of this workshop was to establish a core outcomes set for trials in people with suspected or confirmed coronavirus disease 2019. DESIGN: Four international online multistakeholder consensus workshops were convened to discuss proposed core outcomes for trials in people with suspected or confirmed coronavirus disease 2019, informed by a survey involving 9,289 respondents from 111 countries. The transcripts were analyzed thematically. The workshop recommendations were used to finalize the core outcomes set. SETTING: International. SUBJECTS: Adults 18 years old and over with confirmed or suspected coronavirus disease 2019, their family members, members of the general public and health professionals (including clinicians, policy makers, regulators, funders, researchers). INTERVENTIONS: None. MEASUREMENTS: None. MAIN RESULTS: Six themes were identified. "Responding to the critical and acute health crisis" reflected the immediate focus on saving lives and preventing life-threatening complications that underpinned the high prioritization of mortality, respiratory failure, and multiple organ failure. "Capturing different settings of care" highlighted the need to minimize the burden on hospitals and to acknowledge outcomes in community settings. "Encompassing the full trajectory and severity of disease" was addressing longer term impacts and the full spectrum of illness (e.g. shortness of breath and recovery). "Distinguishing overlap, correlation and collinearity" meant recognizing that symptoms such as shortness of breath had distinct value and minimizing overlap (e.g. lung function and pneumonia were on the continuum toward respiratory failure). "Recognizing adverse events" refers to the potential harms of new and evolving interventions. "Being cognizant of family and psychosocial wellbeing" reflected the pervasive impacts of coronavirus disease 2019. CONCLUSIONS: Mortality, respiratory failure, multiple organ failure, shortness of breath, and recovery are critically important outcomes to be consistently reported in coronavirus disease 2019 trials

Abstracts from the NIHR INVOLVE Conference 2017

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Digital contact tracing technologies in epidemics: a rapid review

Why is this question important? The global COVID‐19 pandemic highlights the importance of accurate and timely contact tracing. Contact tracing tells people that they may have been near someone with ‐ or showing symptoms of ‐ an infectious disease, allowing them to self‐isolate and helping to stop the spread of infection. Traditionally, contact tracing begins with notification that someone has an infectious disease. They are asked to recall their contacts, going back two to three days before symptom onset. This is time‐consuming and may not always give a complete picture, so digital aids could help contact tracers. Digital contact tracing uses technology to track and trace contacts. Individuals download an app onto their smartphones and record location and symptom information, or their devices might use location‐finding technology, like Bluetooth or GPS (global positioning system). If the user is infected, the technology identifies close contacts and/or secondary infections (people to whom they passed the disease), and informs people whom they have been near. The technology identifies where the infection was passed on and its duration (the context). However, problems may occur where access to technology is limited, in low‐income settings or for elderly people, for example. Also, some people see it as an invasion of privacy and are suspicious of how their data will be used. We wanted to know whether digital contact tracing, compared to manual contact tracing, is effective in reducing the spread of infection, as measured by secondary infections, identifying close contacts, tracing a complete set of contacts, and identifying the context of infection. What did we do? We searched medical databases for studies that assessed digital contact tracing. We preferred studies set during infectious disease outbreaks, which assessed real people in real time, but we included studies in any setting and of any design. To answer our question quickly, we shortened some steps of the Cochrane review process, however, we are confident in our conclusions. What we found We found 12 relevant studies. Six assessed the effectiveness of digital contact tracing on specific groups (cohorts) of people: three during an outbreak (Ebola in Sierra Leone; tuberculosis in Botswana; and whooping cough (pertussis) in USA); and three replicated an outbreak in schools to assess systems for identifying close contacts of participants. The remaining six were modelling studies, which simulated digital contact tracing. Main results Digital contact tracing with self‐isolation probably reduces the number of secondary infections, but not as much as manual contact tracing with self‐isolation (2 modelling studies). Digital contact tracing found more close contacts in two outbreaks than manual (2 studies in USA and Sierra Leone). Devices in non‐outbreak settings can identify more close contacts than self‐reported diaries or surveys. An app may reduce the time to complete a set of close contacts (1 study). Digital systems were faster to use than paper systems for recording new contacts and monitoring known contacts, and possibly less prone to data loss. Problems with system access (2 studies) included patchy network coverage, lack of data, technical problems and higher staff training needs. Contact tracers' personal expenses increased (1 study) due to travel and recharging phone batteries. Devices all appeared to protect diagnosed users from contacts, snoopers and authorities but one app's users were members of public health agencies. Studies recorded stolen hardware (second‐hand mobile phones); reported that paper forms were "often lost", and that digital data were password protected (2 studies) and encrypted (1 study). We found no evidence on contextual information and acceptability. What this means It is unlikely that digital technologies would be the sole method of contact tracing during an outbreak; they would probably be used alongside manual methods. Unfortunately, the technology is largely unproven in real‐world outbreak settings and none of our included studies assessed digital plus manual contact tracing with digital contact tracing alone. Our included studies assessed different technologies and used different methods from each other, so we are uncertain about their evidence. Governments that implement digital contact tracing should ensure that at‐risk populations are not disadvantaged and take privacy concerns into account. This review is up to date to May 2020

Core outcomes set for trials in people with coronavirus disease 2019

Objectives: The outcomes reported in trials in coronavirus disease 2019 are extremely heterogeneous and of uncertain patient relevance, limiting their applicability for clinical decision-making. The aim of this workshop was to establish a core outcomes set for trials in people with suspected or confirmed coronavirus disease 2019. Design: Four international online multistakeholder consensus workshops were convened to discuss proposed core outcomes for trials in people with suspected or confirmed coronavirus disease 2019, informed by a survey involving 9,289 respondents from 111 countries. The transcripts were analyzed thematically. The workshop recommendations were used to finalize the core outcomes set. Setting: International. Subjects: Adults 18 years old and over with confirmed or suspected coronavirus disease 2019, their family members, members of the general public and health professionals (including clinicians, policy makers, regulators, funders, researchers). Interventions: None. Measurements: None. Main Results: Six themes were identified. "Responding to the critical and acute health crisis"reflected the immediate focus on saving lives and preventing life-threatening complications that underpinned the high prioritization of mortality, respiratory failure, and multiple organ failure. "Capturing different settings of care"highlighted the need to minimize the burden on hospitals and to acknowledge outcomes in community settings. "Encompassing the full trajectory and severity of disease"was addressing longer term impacts and the full spectrum of illness (e.g. shortness of breath and recovery). "Distinguishing overlap, correlation and collinearity"meant recognizing that symptoms such as shortness of breath had distinct value and minimizing overlap (e.g. lung function and pneumonia were on the continuum toward respiratory failure). "Recognizing adverse events"refers to the potential harms of new and evolving interventions. "Being cognizant of family and psychosocial wellbeing"reflected the pervasive impacts of coronavirus disease 2019. Conclusions: Mortality, respiratory failure, multiple organ failure, shortness of breath, and recovery are critically important outcomes to be consistently reported in coronavirus disease 2019 trials