Clinical trials and their impact on policy during COVID-19: a review.

Background: Of over 8,000 recorded randomised trials addressing COVID-19, around 80% were of treatments, and 17% have reported results. Approximately 1% were adaptive or platform trials, with 25 having results available, across 29 journal articles and 10 preprint articles. Methods: We conducted an extensive literature review to address four questions about COVID-19 trials, particularly the role and impact of platform/adaptive trials and lessons learned. Results: The key findings were: Q1. Social value in conducting trials and uptake into policy? COVID-19 drug treatments varied substantially and changed considerably, with drugs found effective in definitive clinical trials replacing unproven drugs. Dexamethasone has likely saved ½-2 million lives, and was cost effective across a range of countries and populations, whereas the cost effectiveness of remdesivir is uncertain. Published economic and health system impacts of COVID-19 treatments were infrequent. Q2. Issues with adaptive trial designs. Of the 77 platform trials registered, 6 major platform trials, with approximately 50 treatment arms, recruited ~135,000 participants with funding over $100 million. Q3. Models of good practice. Streamlined set-up processes such as flexible and fast-track funding, ethics, and governance approvals are vital. To facilitate recruitment, simple and streamlined research processes, and pre-existing research networks to coordinate trial planning, design, conduct and practice change are crucial to success. Q4. Potential conflicts to avoid? When treating patients through trials, balancing individual and collective rights and allocating scarce resources between healthcare and research are challenging. Tensions occur between commercial and non-commercial sectors, and academic and public health interests, such as publication and funding driven indicators and the public good. Conclusion: There is a need to (i) reduce small, repetitive, single centre trials, (ii) increase coordination to ensure robust research conducted for treatments, and (iii) a wider adoption of adaptive/platform trial designs to respond to fast-evolving evidence landscape.

Evaluating the use of clinical decision aids in an Australian emergency department: A cross-sectional survey.

OBJECTIVE: To identify healthcare professionals' knowledge, self-reported use, and documentation of clinical decision aids (CDAs) in a large ED in Australia, to identify behavioural determinants influencing the use of CDAs, and healthcare professionals preferences for integrating CDAs into the electronic medical record (EMR) system. METHODS: Healthcare professionals (doctors, nurses and physiotherapists) working in the ED at the Gold Coast Hospital, Queensland were invited to complete an online survey. Quantitative data were analysed using descriptive statistics, and where appropriate, mapped to the theoretical domains framework to identify potential barriers to the use of CDAs. Qualitative data were analysed using content analysis. RESULTS: Seventy-four healthcare professionals (34 medical officers, 31 nurses and nine physiotherapists) completed the survey. Healthcare professionals' knowledge and self-reported use of 21 validated CDAs was low but differed considerably across CDAs. Only 4 out of 21 CDAs were reported to be used 'sometimes' or 'always' by the majority of respondents (Ottawa Ankle Rule for ankle injury, Wells' criteria for pulmonary embolism, Wells' criteria for deep vein thrombosis and PERC rule for pulmonary embolism). Most respondents wanted to increase their use of valid and reliable CDAs and supported the integration of CDAs into the EMR to facilitate their use and support documentation. Potential barriers impacting the use of CDAs represented three theoretical domains of knowledge, social/professional role and identity, and social influences. CONCLUSIONS: CDAs are used variably by healthcare professionals and are inconsistently applied in the clinical encounter. Preferences of healthcare professionals need to be considered to allow the successful integration of CDAs into the EMR.

Perceptions of gender equity among critical care and other health professionals: A cross-sectional survey.

OBJECTIVE: The objective of this study was to determine the association between gender and perceived gender equity in the critical care workforce and other health specialties. DESIGN AND SETTING: We conducted an online cross-sectional survey between September and November 2020. Data on demographics and perceptions of equity including the representation of women across departments and in leadership roles, knowledge of and access to flexible work practices and carers leave, and opportunities for promotion were collected. PARTICIPANTS: The study population included health professionals from critical care (defined as intensive care and emergency) and other specialties. We conducted a descriptive gender-disaggregated analysis. RESULTS: A total of 478 respondents (70% women) completed the survey. The mean age of respondents was 43.9 ± 11.2 years. Approximately half of respondents were medical practitioners (n = 235, 54%), followed by nurses (n = 135, 36%)-the remainder were from other professions. The critical care workforce accounted for 280 (64%) of responder practice settings. Statistically significant differences were reported between genders on issues such as having confidence that their department would resolve equity issues (87 [70.7%] men vs. 146 [48.2%] women; p = 0.007), access to flexible work practices (5/124 [4.0%] men vs. 20/305 [6.6%] women p = 0.001), and taking unpaid leave for carer responsibilities (91 [30.3%] women vs 9 [7.4%] men, p < 0.001). CONCLUSIONS: This work highlights differences in how men and women perceive gender equity, particularly in the critical care workforce. These findings are important to understand health care practitioners' perceptions of gender equity, as these perceptions inform behaviour.

Evaluating the use of the ABCD2 score as a clinical decision aid in the emergency department: Retrospective observational study.

OBJECTIVE: Clinical decision aids (CDAs) can help clinicians with patient risk assessment. However, there is little data on CDA calculation, interpretation and documentation in real-world ED settings. The ABCD2 score (range 0-7) is a CDA used for patients with transient ischaemic attack (TIA) and assesses risk of stroke, with a score of 0-3 being low risk. The aim of this study was to describe ABCD2 score documentation in patients with an ED diagnosis of TIA. METHODS: Retrospective observational study of patients with a working diagnosis of a TIA in two Australian EDs. Data were gathered using routinely collected data from health informatics sources and medical records reviewed by a trained data abstractor. ABCD2 scores were calculated and compared with what was documented by the treating clinician. Data were presented using descriptive analysis and scatter plots. RESULTS: Among the 367 patients with an ED diagnosis of TIA, clinicians documented an ABCD2 score in 45% (95% CI 40-50%, n = 165). Overall, there was very good agreement between calculated and documented scores (Cohen's kappa 0.90). The mean documented and calculated ABCD2 score were similar (3.8, SD = 1.5, n = 165 vs 3.7, SD = 1.8, n = 367). Documented scores on the threshold of low and high risk were more likely to be discordant with calculated scores. CONCLUSIONS: The ABCD2 score was documented in less than half of eligible patients. When documented, clinicians were generally accurate with their calculation and application of the ABCD2. No independent predictors of ABCD2 documentation were identified.

Delivering Prognostic News to Older People with Chronic Disease: What Format Preference and Level of Involvement in Decision Making? A Hospital Survey.

Shared decision making near end of life is a balancing act of communicating prognosis to patients and their surrogates/families and engaging them in considering value-concordant management choices. This cross-sectional survey aimed to determine the format in which older patients with chronic illnesses would prefer to receive prognostic information on their treatment options and disease progression, and their desired level of engagement in decision making. With a 60% participation rate, 139 inpatients in two hospitals and five surrogates were presented with six hypothetical scenarios with a randomly assigned sequence: verbal and written summary, graph, table, photo, video, and pamphlet. The majority (76%) of respondents chose the traditional verbal communication of prognosis by their doctor with a written summary as a reference and to share with family; the second choice was a condition-specific pamphlet (63%). Many found the graph and photo to be distressing (36% and 42%, respectively). Most (71%) wanted to know everything about their condition trajectory, and 63% chose shared decision making rather than completely autonomous or full delegation to clinicians or family. There were no gender differentials between wanting to know it all, supporting shared decision making or the preferred format for breaking news (p > 0.05). Older hospitalized patients with chronic conditions are willing to discuss end-of-life issues, learn about their prognosis, and be involved in shared decision making. Innovative formats such as graphs, videos, or photos were not welcome as part of the prognostic discussion.