Consumer perspectives on simplified, layered consent for a low risk, but complex pragmatic trial.

BACKGROUND: For decades, the research community has called for participant information sheets/consent forms (PICFs) to be improved. Recommendations include simplifying content, reducing length, presenting information in layers and using multimedia. However, there are relatively few studies that have evaluated health consumers' (patients/carers) perspectives on the type and organisation of information, and the level of detail to be included in a PICF to optimise an informed decision to enter a trial. We aimed to elicit consumers' views on a layered approach to consent that provides the key information for decision-making in a short PICF (layer 1) with additional optional information that is accessed separately (layer 2). We also elicited consumers' views on the optimal content and layout of the layered consent materials for a large and complex Bayesian adaptive platform trial (the SNAP trial). METHODS: We conducted a qualitative multicentre study (4 focus groups and 2 semi-structured interviews) involving adolescent and adult survivors of Staphylococcus aureus bloodstream infection (22) and their carers (2). Interview transcripts were examined using inductive thematic analysis. RESULTS: Consumers supported a layered approach to consent. The primary theme that emerged was the value of agency; the ability to exert some control over the amount of information read before the consent form is signed. Three other themes emerged; the need to prioritise participants' information needs; the importance of health literacy; the importance of information about a trial's benefits (over its risks) for decision-making and the interplay between the two. CONCLUSIONS: Our findings suggest that consumers may challenge the one-size-fits-all approach currently applied to the development of PICFs in countries like Australia. Consumers supported a layered approach to consent that offers choice in the amount of information to be read before deciding whether to enter a trial. A 3-page PICF was considered sufficient for decision-making for the SNAP trial, provided that further information was available and accessible.

COVID-19 in the pre-pandemic period: a survey of the time commitment and perceptions of infectious diseases physicians in Australia and New Zealand.

BACKGROUND: Infectious diseases (ID) physicians perform a pivotal role in directing the response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). AIM: To assess the impact of SARS-CoV-2 on workload and the perceptions of ID physicians regarding the national response in Australia and New Zealand in the pre-pandemic. METHODS: A survey of ID physicians in Australia and New Zealand was undertaken from 3 to 10 March 2020. Respondents were asked to estimate time spent on SARS-CoV-2-related activities in February and report their agreement with statements on a 5-point Likert scale ranging from 'strongly agree' to 'strongly disagree'. We also asked about the intended use of investigational agents. RESULTS: There were 214 respondents (36% of 600 eligible participants). The median workload due to SARS-CoV-2-related activities was 34% of one full-time equivalent (interquartile range 18-68%). Less than a quarter (50, 23%) of respondents had experience managing cases, while 33% (70) had experience preparing during similar pandemics. Nevertheless, 88% (188/213) believed they were well informed when giving testing and management advice, and 45% (95/212) believed their national response was well coordinated. Additionally, 41% (88/214) were worried about becoming infected through occupational exposure. Over half (116, 54%) the respondents intended to use lopinavir/ritonavir in confirmed cases of COVID-19 with severe disease. CONCLUSIONS: ID physicians spent a large proportion of time on SARS-CoV-2-related activities. Increased staffing is required to avoid burnout. Importantly, ID physicians feel well informed when giving advice. A national body should be established to co-ordinate response. Treatment efficacy trials are needed to clarify the utility of unproven treatments.

Clinical trials for the prevention and treatment of COVID-19: current state of play.

Since coronavirus disease 2019 (COVID-19) emerged in Wuhan, China in December 2019 and spread around the world, over 1100 clinical studies have been registered globally on clinical trials registries, including over 500 randomised controlled trials. Such rapid development and launch of clinical trials is impressive but presents challenges, including the potential for duplication and competition. There is currently no known effective treatment for COVID-19. In order to focus on those studies most likely to influence clinical practice, we summarise the 31 currently registered randomised trials with a target sample size of at least 1000 participants. We have grouped these trials into four categories: prophylaxis; treatment of outpatients with mild COVID-19; treatment of hospitalised patients with moderate COVID-19; and treatment of hospitalised patients with moderate or severe disease. The most common therapeutic agent being trialled currently is hydroxychloroquine (24 trials with potential sample size of over 25 000 participants), followed by lopinavir-ritonavir (seven trials) and remdesevir (five trials) There are many candidate drugs in pre-clinical and early phase development, and these form a pipeline for future large clinical trials if current candidate therapies prove ineffective or unsafe.

COVID-19 and paediatric health services: A survey of paediatric physicians in Australia and New Zealand.

AIMS: COVID-19 is now a global pandemic. At the time of survey, fewer than 150 children in Australia and New Zealand had documented infection. The aim of this study was to assess attitudes, readiness and confidence in the early stages of the COVID-19 pandemic through an online survey of paediatric physicians and sub-specialists across Australia and New Zealand. METHODS: Multiple email list groups were used to contact paediatric physicians to undertake an online Likert scale survey between 17 and 24 March. Respondents' specialty, experience and work setting were recorded. Ordinal logistic regression was used to determine respondent factors. RESULTS: There were 542 respondents from across Australia and New Zealand: an estimated 11% of the paediatric physician workforce. A minority (36.6%) agreed that their national response had been well coordinated; the majority (92.7%) agreed that senior-level hospital administrators were taking the situation seriously. Most reported a good understanding of the natural history of COVID-19 in children, and knowledge of where to find local information. A large proportion of physicians (86.1%) were worried about becoming infected through their work; few (5.8%) reported that they would not come to work to avoid infection. Closure of school and childcares would reduce the ability to continue work at current capacity for 23.6% of respondents. CONCLUSION: Despite limited experience in pandemics, most paediatric physicians felt informed. Concern about exposure at work is common; most were willing to work regardless. The closure of schools and daycares may have an impact on staffing. Coordination and leadership will be critical.