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BackgroundAutoinflation balloons are used to treat patients with otitis media with effusion (OME) to help avoid surgery.AimTo compare the ability of party balloons with Otovent balloons to produce sufficient pressure for a Valsalva manoeuvre.Design & settingPressure testing was used to determine the number of times each balloon could produce pressures sufficient for a Valsalva manoeuvre. Subsequently, Otovent balloons were compared with spherical party balloons in a pilot clinical trial of 12 healthy adults.MethodEach balloon was inflated 20 times and the maximum pressure was recorded. Three balloons of each type were tested to 50 inflations to assess pressures over persistent use.ResultsOtovent balloons’ mean inflation pressure was 93 mmHg (95% confidence interval [CI] = 89 to 97 mmHg) on first inflation, dropping to 83 mmHg (95% CI = 80 to 86 mmHg) after 20 inflations. Two types of spherical party balloon required mean inflation pressures of 84 mmHg (95% CI = 77 to 90 mmHg) and 108 mmHg (95% CI = 97 to 119 mmHg) on first inflation, dropping to 74 mmHg (95% CI = 68 to 81 mmHg) and 83 mmHg (95% CI = 77 to 88 mmHg) after 20 inflations. In the pilot trial, there was no difference between the ability of Otovent and spherical balloons (χ2 = 0.24, P = 0.89) to produce the sensation of a Valsalva manoeuvre.ConclusionOtovent balloons can be used more than the 20 times quoted by the manufacturer. The two spherical balloons produced similar pressures to Otovent balloons, indicating potentially the same clinical effect. The pilot study suggests a potential use of spherical party balloons instead of Otovent balloons as a cost-efficient treatment.

Many randomized controlled trials (RCTs) are biased and difficult to reproduce due to methodological flaws and poor reporting. There is increasing attention for responsible research practices and implementation of reporting guidelines, but whether these efforts have improved the methodological quality of RCTs (e.g., lower risk of bias) is unknown. We, therefore, mapped risk-of-bias trends over time in RCT publications in relation to journal and author characteristics. Meta-information of 176,620 RCTs published between 1966 and 2018 was extracted. The risk-of-bias probability (random sequence generation, allocation concealment, blinding of patients/personnel, and blinding of outcome assessment) was assessed using a risk-of-bias machine learning tool. This tool was simultaneously validated using 63,327 human risk-of-bias assessments obtained from 17,394 RCTs evaluated in the Cochrane Database of Systematic Reviews (CDSR). Moreover, RCT registration and CONSORT Statement reporting were assessed using automated searches. Publication characteristics included the number of authors, journal impact factor (JIF), and medical discipline. The annual number of published RCTs substantially increased over 4 decades, accompanied by increases in authors (5.2 to 7.8) and institutions (2.9 to 4.8). The risk of bias remained present in most RCTs but decreased over time for allocation concealment (63% to 51%), random sequence generation (57% to 36%), and blinding of outcome assessment (58% to 52%). Trial registration (37% to 47%) and the use of the CONSORT Statement (1% to 20%) also rapidly increased. In journals with a higher impact factor (>10), the risk of bias was consistently lower with higher levels of RCT registration and the use of the CONSORT Statement. Automated risk-of-bias predictions had accuracies above 70% for allocation concealment (70.7%), random sequence generation (72.1%), and blinding of patients/personnel (79.8%), but not for blinding of outcome assessment (62.7%). In conclusion, the likelihood of bias in RCTs has generally decreased over the last decades. This optimistic trend may be driven by increased knowledge augmented by mandatory trial registration and more stringent reporting guidelines and journal requirements. Nevertheless, relatively high probabilities of bias remain, particularly in journals with lower impact factors. This emphasizes that further improvement of RCT registration, conduct, and reporting is still urgently needed., Many randomized controlled trials (RCTs) are biased and difficult to reproduce due to methodological flaws and poor reporting. Analysis of 176,620 RCTs published between 1966 and 2018 reveals that the risk of bias in RCTs generally decreased. Nevertheless, relatively high probabilities of bias remain, showing that further improvement of RCT registration, conduct, and reporting is still urgently needed.

© 2021 Elsevier B.V. The prevalence of multimorbidity and polypharmacy increases significantly with age and are associated with negative health consequences. However, most current interventions to optimize medication have failed to show significant effects on patient-relevant outcomes. This may be due to ineffectiveness of interventions themselves but may also reflect other factors: insufficient sample sizes, heterogeneity of population. To address this issue, the international PROPERmed collaboration was set up to obtain/synthesize individual participant data (IPD) from five cluster-randomized trials. The trials took place in Germany and The Netherlands and aimed to optimize medication in older general practice patients with chronic illness. PROPERmed is the first database of IPD to be drawn from multiple trials in this patient population and setting. It offers the opportunity to derive prognostic models with increased statistical power for prediction of patient-relevant outcomes resulting from the interplay of multimorbidity and polypharmacy. This may help patients from this heterogeneous group to be stratified according to risk and enable clinicians to identify patients that are likely to benefit most from resource/time-intensive interventions. The aim of this manuscript is to describe the rationale behind PROPERmed collaboration, characteristics of the included studies/participants, development of the harmonized IPD database and challenges faced during this process.

Herzog and colleagues raise the thorny issue of allocating scarce vaccines, comparing the proportional allocation model with a fair priority model.1 Regardless of what is used for prioritisation between and within countries, there will be a long period of rollout before most of the world’s population are offered vaccination. For groups of equivalent priority, a fair and equitable way to decide on the order of rollout is to use a lottery, or system of random choice.2 Such randomised …

Background and objectives Evidence supports some beneficial effects of antibiotics prescribed to patients with a sore throat and proven presence of group A streptococci (GAS). Methods A total of 283 patients were included from North and North-West Queensland, Australia, at their first presentation for uncomplicated acute sore throat. Patterns of antibiotic prescribing were explored before and after testing for GAS using a rapid point-of-care polymerase chain reaction (PCR) test. Results The results of the study showed the Australian Therapeutic Guidelines were often not adhered to. The PCR test reduced the proportion of patients prescribed antibiotics from 46% to 40%. The decision to prescribe antibiotics was changed in 30% of patients (P

BackgroundWe conducted a survey to identify what types of health research could be exempted from research ethics reviews in Australia.MethodsWe surveyed active Australian health researchers and members of Human Research Ethics Committees (HREC). We presented the respondents with eight hypothetical research scenarios, involving: N of 1 trials, no treatment studies, linked data sets, surplus samples, audits, surveys, interviews with patients, and professional opinion. We asked whether these scenarios should or should not be exempt from ethics review, and to provide (optional) explanations. We analysed the reasons thematically, to identify Top 3 reasons underlying the decisions.ResultsMost frequent reasons for requiring ethics reviews, included: the need for independent oversight, privacy/confidentiality issues, review of scientific rigour, and publishing considerations. Most frequent reasons for exempting scenarios from reviews, included: level of risk, study design, privacy/confidentiality issues, and standard clinical practice. Four research scenarios listed the same Top 3 reasons for requiring ethics reviews: need for independent oversight, review of scientific rigour, privacy/confidentiality. Reasons for exempting were less uniform, but low risk was a Top 3 reason for 7 scenarios, and study design for 4 scenarios. Privacy/confidentiality was given as a Top 3 reason for both requiring and exempting from ethics the same two scenarios.ConclusionsThe most frequently offered reasons in support of requiring ethics reviews for research scenarios are more uniform than those for exempting them. However, considerable disagreement exists about when the risks of research are so minimal that the exemption is appropriate.

PURPOSE: To determine whether acute respiratory infection (ARI) decision aids and a general practitioner (GP) training package reduces antibiotic dispensing rate and improves GPs’ knowledge of antibiotic benefit-harm evidence. METHODS: A cluster randomized trial of 27 Australian general practices (13 intervention, 14 control) involving 122 GPs. Intervention group GPs were given brief decision aids for 3 ARIs (acute otitis media, acute sore throat, acute bronchitis) and video-delivered training. Primary outcome was dispensing rate of target antibiotic classes (routinely used for ARIs), extracted for 12 months before, and following, randomization. Secondary outcomes were GPs’ knowledge of antibiotic benefit-harm evidence; prescribing influences; acceptability, usefulness, and self-reported resource use; and dispensing rate of all antibiotics. RESULTS: The baseline mean dispensing rate of ARI-related antibiotics was 3.5% (intervention GPs) and 3.2% (control GPs) of consultations. After 12 months, mean rates decreased (to 2.9% intervention; 2.6% control): an 18% relative reduction from baseline but similar in both groups (rate ratio 1.01; 95% CI, 0.89-1.15). Greater increases in knowledge were seen in the intervention group than control; a significant increase (average 3.6; 95% CI, 2.4-4.7, P

BackgroundWe conducted a survey to identify what types of health/medical research could be exempt from research ethics reviews in Australia.MethodsWe surveyed Australian health/medical researchers and Human Research Ethics Committee (HREC) members. The survey asked whether respondents had previously changed or abandoned a project anticipating difficulties obtaining ethics approval, and presented eight research scenarios, asking whether these scenarios should or should not be exempt from ethics review, and to provide (optional) comments. Qualitative data were analysed thematically; quantitative data in R.ResultsWe received 514 responses. Forty-three per cent of respondents to whom the question applied, reported changing projects in anticipation of obstacles from the ethics review process; 25% reported abandoning projects for this reason. Research scenarios asking professional staff to provide views in their area of expertise were most commonly exempted from ethics review (to prioritise systematic review topics 84%, on software strengths/weaknesses 85%); scenarios involving surplus samples (82%) and N-of-1 (single case) studies (76%) were most commonly required to undergo ethics review. HREC members were 26% more likely than researchers to require ethics review. Need for independent oversight, and low risk, were most frequently cited in support of decisions to require or exempt from ethics review, respectively.ConclusionsConsiderable differences exist between researchers and HREC members, about when to exempt from review the research that ultimately serves the interests of patients and the public. It is widely accepted that evaluative research should be used to reduce clinical uncertainties—the same principle should apply to ethics reviews.

BackgroundAntibiotics are overused for non-pneumonia acute respiratory tract infections (ARTIs).AimTo establish prevalence and explore associations of delayed and immediate antibiotic prescribing strategies of Australian early-career GPs (specialist GP vocational trainees, also known as GP registrars) for non-pneumonia ARTIs.Design and settingCross-sectional analysis of data collected between September 2016 and December 2017 from the Registrar Clinical Encounters in Training cohort (ReCEnT) study, an ongoing cohort study of GP registrars’ in-practice clinical experiences in four Australian states and territories.MethodMultinomial logistic regression with outcome antibiotic prescribing (no prescribing, immediate prescribing, and delayed prescribing).ResultsOf 7156 new ARTI diagnoses, no antibiotics were prescribed for 4892 (68%); antibiotics were prescribed for immediate use for 1614 diagnoses (23%) and delayed antibiotics were used for 650 diagnoses (9%). Delayed prescribing was used in 22% of otitis media, 16% of sinusitis, 13% of sore throat, 11% of acute bronchitis/bronchiolitis, and 5% of upper respiratory tract infection (URTI) diagnoses. Delayed prescribing was used for 29% of all prescriptions written. Delayed prescribing and immediate prescribing were associated with markers of clinical concern. Delayed prescribing was associated with longer duration of consultation and with fewer diagnoses/problems dealt with in the consultation.ConclusionAustralian early-career GPs use no prescribing for ARTIs substantially more than established GPs; however, except where URTIs are concerned, they still prescribe antibiotics in excess of validated benchmarks. Australian early-career GPs may use delayed prescribing more often than European established GPs, and may use it to manage diagnostic uncertainty and, possibly, conflicting influences on prescribing behaviour. The use of delayed prescribing may enable a transition to an environment of more-rational antibiotic prescribing for ARTIs.

Item does not contain fulltext PURPOSE: To assess opportunities to improve reporting of primary care (PC) research to better meet the needs of its varied users. METHODS: International, interprofessional online survey of PC researchers and users, 2018 to 2019. Respondents used Likert scales to rate frequency of difficulties in interpreting, synthesizing, and applying PC research reports. Free-text short answers were categorized by template analysis to record experiences, concerns, and suggestions. Areas of need were checked across existing reporting guidelines. RESULTS: Survey yielded 255 respondents across 24 nations, including 138 women (54.1%), 169 physicians (60%), 32 scientists (11%), 20 educators (7%), and 18 public health professionals (6%). Overall, 37.4% indicated difficulties using PC research reports "50% or more of the time." The most common problems were synthesizing findings (58%) and assessing generalizability (42%). Difficulty was reported by 49% for qualitative, 46% for mixed methods, and 38% for observational research. Most users wanted richer reporting of theoretical foundation (53.7%); teams, roles, and organization of care (53.4%); and patient involvement in the research process (52.7%). Few reported difficulties with ethics or disclosure of funding or conflicts. Free-text answers described special challenges in reporting PC research: context of clinical care and setting; practical details of interventions; patient-clinician and team relationships; and generalizability, applicability and impact in the great variety of PC settings. Cross-check showed that few current reporting guidelines focus on these needs. CONCLUSIONS: Opportunities exist to improve the reporting of PC research to make it more useful for its many users, suggesting a role for a PC research reporting guideline.

Item does not contain fulltext PURPOSE: To assess how primary care practitioners use reports of general health care (GHC) and primary care (PC) research and how well reports deliver what they need to inform clinical practice. METHODS: International, interprofessional online survey, 2019, of primary care clinicians who see patients at least half time. Respondents used frequency scales to report how often they access both GHC and PC research and how frequently reports meet needs. Free-text short comments recorded comments and suggestions. RESULTS: Survey yielded 252 respondents across 29 nations, 55% (121) women, including 88% (195) physicians, nurses 5% (11), and physician assistants 3% (7). Practitioners read research reports frequently but find they usually fail to meet their needs. For PC research, 33% (77) accessed original reports in academic journals weekly or daily, and 36% found reports meet needs "frequently" or "always." They access reports of GHC research slightly more often but find them somewhat less useful. CONCLUSIONS: PC practitioners access original research in academic journals frequently but find reports meet information needs less than half the time. PC research reflects the unique PC setting and so reporting has distinct focus, needs, and challenges. Practitioners desire improved reporting of study context, interventions, relationships, generalizability, and implementation.

BACKGROUND Timely and effective contact tracing is an essential public health measure for curbing the transmission of COVID-19. App-based contact tracing has the potential to optimize the resources of overstretched public health departments. However, its efficiency is dependent on widespread adoption. OBJECTIVE This study aimed to investigate the uptake of the Australian Government’s COVIDSafe app among Australians and examine the reasons why some Australians have not downloaded the app. METHODS An online national survey, with representative quotas for age and gender, was conducted between May 8 and May 11, 2020. Participants were excluded if they were a health care professional or had been tested for COVID-19. RESULTS Of the 1802 potential participants contacted, 289 (16.0%) were excluded prior to completing the survey, 13 (0.7%) declined, and 1500 (83.2%) participated in the survey. Of the 1500 survey participants, 37.3% (n=560) had downloaded the COVIDSafe app, 18.7% (n=280) intended to do so, 27.7% (n=416) refused to do so, and 16.3% (n=244) were undecided. Equally proportioned reasons for not downloading the app included privacy (165/660, 25.0%) and technical concerns (159/660, 24.1%). Other reasons included the belief that social distancing was sufficient and the app was unnecessary (111/660, 16.8%), distrust in the government (73/660, 11.1%), and other miscellaneous responses (eg, apathy and following the decisions of others) (73/660, 11.1%). In addition, knowledge about COVIDSafe varied among participants, as some were confused about its purpose and capabilities. CONCLUSIONS For the COVIDSafe app to be accepted by the public and used correctly, public health messages need to address the concerns of citizens, specifically privacy, data storage, and technical capabilities. Understanding the specific barriers preventing the uptake of contact tracing apps provides the opportunity to design targeted communication strategies aimed at strengthening public health initiatives, such as downloading and correctly using contact tracing apps.

ObjectiveTo compare the effectiveness of hand hygiene using alcohol-based hand sanitiser to soap and water for preventing the transmission of acute respiratory infections (ARIs), and assess the relationship between the dose of hand hygiene and the number of ARI, influenza-like illness (ILI), or influenza events.MethodsSystematic review of randomised trials that compared a community-based hand hygiene intervention (soap and water, or sanitiser) with a control, or trials that compared sanitiser with soap and water, and measured outcomes of ARI, ILI, or laboratory-confirmed influenza or related consequences. Searches were conducted in CENTRAL, PubMed, Embase, CINAHL and trial registries (April 2020) and data extraction completed by independent pairs of reviewers.ResultsEighteen trials were included. When meta-analysed, three trials of soap and water versus control found a non-significant increase in ARI events (Risk Ratio (RR) 1.23, 95%CI 0.78-1.93); six trials of sanitiser versus control found a significant reduction in ARI events (RR 0.80, 95%CI 0.71-0.89). When hand hygiene dose was plotted against ARI relative risk, no clear dose-response relationship was observable. Four trials were head-to-head comparisons of sanitiser and soap and water but too heterogeneous to pool: two found a significantly greater reduction in the sanitiser group compared to the soap group; two found no significant difference between the intervention arms.ConclusionAdequately performed hand hygiene, with either soap or sanitiser, reduces the risk of ARI virus transmission, however direct and indirect evidence suggest sanitiser might be more effective in practice.

ObjectivesTo identify what types of health and medical research could be exempted from a requirement to undergo research ethics reviews in Australia.DesignA web-based survey.SettingAustralian-based participants completed the survey online between 10 September and 1 November 2019.ParticipantsActive human health and medical researchers and members of Human Research Ethics Committees (HREC).Main outcome measuresParticipants were asked whether they self-identify as a researcher, a member of an Australian human research ethics committee, or both. They were asked whether they had previously changed or abandoned a research project in anticipation of difficulty in obtaining ethics approval; and were presented with 4 hypothetical research scenarios, asking whether they should or should not be exempt from ethics review in Australia. All but the demographic question allowed the respondent to provide a comment clarifying their response. Qualitative data were analysed thematically; quantitative data were analysed in R.ResultsWe received 514 survey responses: 153 from researchers, 196 from HREC members, and 163 from individuals who identified as both. 27% of researchers reported they had changed their projects because they anticipated obstacles resulting from the ethics review process, and 16% abandoned projects for this reason. The most commonly exempted research scenarios involved professional staff providing their views on their area of expertise (84%, 85%); scenarios involving surplus samples and N-of-1 studies in clinical practice were most commonly required to undergo ethics review (82%, 76% respectively). Probability of answering that ethics review was required was the highest for HREC members and nearly identical for respondents who were both HREC members and researchers; it was the lowest for researchers. HREC members were overall 26% more likely to answer that ethics review was required than researchers.ConclusionsOur survey shows considerable differences between the researchers and members of ethics committees, about how best to serve the interests of patients and the public. Those interests are best served by evaluative research to reduce or resolve the uncertainties in the clinical context – the same general principle should be applied to ethics review.

Para que o conhecimento beneficie a pesquisa e a sociedade, ele deve ser confiável. A pesquisa confiável é robusta, rigorosa e transparente em todos as etapas relativas ao desenho, execução e relato. Apesar desse avanço, a inclusão de considerações relacionadas à confiabilidade, ao rigor e à transparência continua sendo rara. Os Princípios de Hong Kong (HKPs) foram desenvolvidos como parte da 6a Conferência Mundial sobre Integridade em Pesquisa, com foco sobre a necessidade de impulsionar o aprimoramento da pesquisa, garantindo que os pesquisadores sejam explicitamente reconhecidos e recompensados por atitudes que fortalecem a integridade. Apresentamos cinco princípios: práticas de pesquisa responsáveis; relato transparente; ciência aberta (pesquisa aberta); valorização da diversidade de tipos de pesquisa; reconhecimento de todas as contribuições para a pesquisa e atividade acadêmica. Para cada princípio, oferecemos uma justificativa, com exemplos que ilustram onde esses princípios já estão sendo adotados.

For knowledge to benefit research and society, it must be trustworthy. Trustworthy research is robust, rigorous, and transparent at all stages of design, execution, and reporting. Assessment of researchers still rarely includes considerations related to trustworthiness, rigor, and transparency. We have developed the Hong Kong Principles (HKPs) as part of the 6th World Conference on Research Integrity with a specific focus on the need to drive research improvement through ensuring that researchers are explicitly recognized and rewarded for behaviors that strengthen research integrity. We present five principles: responsible research practices; transparent reporting; open science (open research); valuing a diversity of types of research; and recognizing all contributions to research and scholarly activity. For each principle, we provide a rationale for its inclusion and provide examples where these principles are already being adopted., Assessment of researchers still rarely includes considerations related to trustworthiness, rigor, and transparency. This Essay presents the Hong Kong Principles (HKPs), developed as part of the 6th World Conference on Research Integrity, with a specific focus on the need to drive research improvement by ensuring that researchers are explicitly recognized and rewarded for behavior that leads to trustworthy research.

Objectives Healthcare expenditure is growing at an unsustainable rate in developed countries. A recent scoping review identified several alternative healthcare delivery models with the potential to improve health system sustainability. Our objective was to obtain input and consensus from an expert Delphi panel about which alternative models they considered most promising for increasing value in healthcare delivery in Australia and to contribute to shaping a research agenda in the field. Methods The panel first reviewed a list of 84 models obtained through the preceding scoping review and contributed additional ideas in an open round. In a subsequent scoring round, the panel rated the priority of each model in terms of its potential to improve health care sustainability in Australia. Consensus was assumed when ≥50% of the panel rated a model as (very) high priority (consensus on high priority) or as not a priority or low priority (consensus on low priority). Results Eighty-two of 149 invited participants (55%) representing all Australian states/territories and wide expertise completed round one; 71 completed round two. Consensus on high priority was achieved for 59 alternative models; 14 were rated as (very) high priority by ≥70% of the panel. Top priorities included improving medical service provision in aged care facilities, providing single-point-access multidisciplinary care for people with chronic conditions and providing tailored early discharge and hospital at home instead of in-patient care. No consensus was reached on 47 models, but no model was deemed low priority. Conclusions Input from an expert stakeholder panel identified healthcare delivery models not previously synthesised in systematic reviews that are a priority to investigate. Strong consensus exists among stakeholders regarding which models require the most urgent attention in terms of (cost-)effectiveness research. These findings contribute to shaping a research agenda on healthcare delivery models and where stakeholder engagement in Australia is likely to be high. What is known about the topic? Healthcare expenditure is growing at an unsustainable rate in high-income countries worldwide. A recent scoping review of systematic reviews identified a substantial body of evidence about the effects of a wide range of models of healthcare service delivery that can inform health system improvements. Given the large number of systematic reviews available on numerous models of care, a method for gaining consensus on the models of highest priority for implementation (where evidence demonstrates this will lead to beneficial effects and resource savings) or for further research (where evidence about effects is uncertain) in the Australian context is warranted. What does this paper add? This paper describes a method for reaching consensus on high-priority alternative models of service delivery in Australia. Stakeholders with leadership roles in health policy and government organisations, hospital and primary care networks, academic institutions and consumer advocacy organisations were asked to identify and rate alternative models based on their knowledge of the healthcare system. We reached consensus among ≥70% of stakeholders that improving medical care in residential aged care facilities, providing single-point-access multidisciplinary care for patients with a range of chronic conditions and providing early discharge and hospital at home instead of in-patient stay for people with a range of conditions are of highest priority for further investigation. What are the implications for practitioners? Decision makers seeking to optimise the efficiency and sustainability of healthcare service delivery in Australia could consider the alternative models rated as high priority by the expert stakeholder panel in this Delphi study. These models reflect the most promising alternatives for increasing value in the delivery of health care in Australia based on stakeholders’ knowledge of the health system. Although they indicate areas where stakeholder engagement is likely to be high, further research is needed to demonstrate the effectiveness and cost-effectiveness of some of these models.

BackgroundTimely and effective contact tracing is an essential public health role to curb the transmission of COVID-19. App-based contact tracing has the potential to optimise the resources of overstretched public health departments. However, it’s efficiency is dependent on wide-spread adoption. We aimed to identify the proportion of people who had downloaded the Australian Government COVIDSafe app and examine the reasons why some did not.MethodAn online national survey with representative quotas for age and gender was conducted between May 8 and May 11 2020. Participants were excluded if they were a healthcare professional or had been tested for COVID-19.ResultsOf the 1802 potential participants contacted, 289 were excluded, 13 declined, and 1500 participated in the survey (response rate 83%). Of survey participants, 37% had downloaded the COVIDSafe app, 19% intended to, 28% refused, and 16% were undecided. Equally proportioned reasons for not downloading the app included privacy (25%) and technical concerns (24%). Other reasons included a belief that social distancing was sufficient and the app is unnecessary (16%), distrust in the Government (11%), and apathy (11%). In addition, COVIDSafe knowledge varied with confusion about its purpose and capabilities.ConclusionFor the COVIDSafe app to be accepted by the public and used correctly, public health messages need to address the concerns of its citizens, specifically in regards to privacy, data storage, and technical capabilities. Understanding the specific barriers preventing the uptake of tracing apps provides the opportunity to design targeted communication strategies aimed at strengthening public health initiatives such as download and correct use.

Background Evidence of effectiveness of mobile health (mHealth) apps as well as their usability as non-drug interventions in primary care are emerging around the globe. Objective This study aimed to explore the feasibility of mHealth app prescription by general practitioners (GPs) and to evaluate the effectiveness of an implementation intervention to increase app prescription. Methods A single-group, before-and-after study was conducted in Australian general practice. GPs were given prescription pads for 6 mHealth apps and reported the number of prescriptions dispensed for 4 months. After the reporting of month 2, a 2-minute video of one of the apps was randomly selected and sent to each GP. Data were collected through a prestudy questionnaire, monthly electronic reporting, and end-of-study interviews. The primary outcome was the number of app prescriptions (total, monthly, per GP, and per GP per fortnight). Secondary outcomes included confidence in prescribing apps (0-5 scale), the impact of the intervention video on subsequent prescription numbers, and acceptability of the interventions. Results Of 40 GPs recruited, 39 commenced, and 36 completed the study. In total, 1324 app prescriptions were dispensed over 4 months. The median number of apps prescribed per GP was 30 (range 6-111 apps). The median number of apps prescribed per GP per fortnight increased from the pre-study level of 1.7 to 4.1. Confidence about prescribing apps doubled from a mean of 2 (not so confident) to 4 (very confident). App videos did not affect subsequent prescription rates substantially. Post-study interviews revealed that the intervention was highly acceptable. Conclusions mHealth app prescription in general practice is feasible, and our implementation intervention was effective in increasing app prescription. GPs need more tailored education and training on the value of mHealth apps and knowledge of prescribable apps to be able to successfully change their prescribing habits to include apps. The future of sustainable and scalable app prescription requires a trustworthy electronic app repository of prescribable mHealth apps for GPs.

BackgroundHealthcare acquired infections (HAIs) cause substantial morbidity and mortality. Copper appears to have strong viricidal properties under laboratory conditions.AimWe conducted a systematic review to examine the potential effect of copper treating of commonly touched surfaces in healthcare facilities.MethodsWe included controlled trials comparing the effect of copper-treated surfaces (furniture or bed linens) in hospital rooms versus standard rooms on hospital acquired infections (HAIs). Two reviewers independently screened retrieved articles, extracted data, and assessed the risk of bias of included studies. The primary outcome was the occurrence of healthcare acquired infections.FindingsWe screened 638 records; 7 studies comprising 12362 patients were included. All of included studies were judged to be at high risk in ≥2 of the 7 domains of bias. All 7 included studies reported the effect of copper-treated surfaces HAIs. Overall, we found low quality evidence of a potential clinical importance that copper-treated hard surfaces and/or bed linens and clothes reduced healthcare acquired infections by 27% (RR 0.73; 95% CI 0.57 to 0.94).ConclusionGiven the clinical and economic costs of healthcare acquired infections, the potentially protective effect of copper-treated surfaces appears important. The current evidence is insufficient to make a strong positive recommendation. However, it would appear worthwhile and urgent to conduct larger-scale publicly funded clinical trials of the impact of copper coating.

BackgroundMany randomized controlled trials (RCTs) are biased and difficult to reproduce due to methodological flaws and poor reporting. There is increasing attention for responsible research practices including reporting guidelines, but it is unknown whether these efforts have improved RCT quality (i.e. reduced risk of bias). We therefore mapped trends over time in trial publication, trial registration, reporting according to CONSORT, and characteristics of publication and authors.MethodsMeta-information of 176,620 RCTs published between 1966 and 2018 was extracted. Risk of bias probability (four domains: random sequence generation, allocation concealment, blinding of patients/personnel, and blinding of outcome assessment) was assessed using validated risk-of-bias machine learning tools. In addition, trial registration and reporting according to CONSORT were assessed with automated searches. Characteristics were extracted related to publication (number of authors, journal impact factor, medical discipline) and authors (gender and Hirsch-index).FindingsThe annual number of published RCTs substantially increased over four decades, accompanied by increases in the number of authors (5.2 to 7.8), institutions (2.9 to 4.8), female authors (20 to 42%, first authorship; 17 to 29%, last authorship), and Hirsch-indices (10 to 14, first authorship; 16 to 28, last authorship). Risk of bias remained present in most RCTs but decreased over time for the domains allocation concealment (63 to 51%), random sequence generation (57 to 36%), and blinding of outcome assessment (58 to 52%). Trial registration (37 to 47%) and CONSORT (1 to 20%) rapidly increased in the latest period. In journals with higher impact factor (>10), risk of bias was consistently lower, higher levels of trial registration more frequent, and mentioning CONSORT.InterpretationThe likelihood of bias in RCTs has generally decreased over the last decades. This may be driven by increased knowledge and improved education, augmented by mandatory trial registration, and more stringent reporting guidelines and journal requirements. Nevertheless, relatively high probabilities of bias remain, particularly in journals with lower impact factors. This emphasizes that further improvement of RCT registration, conduct, and reporting is still urgently needed.FundingThis study was funded by The Netherlands Organisation for Health Research and Development (445001002).

OBJECTIVETo assess the effectiveness of hand hygiene, surface disinfecting, and other hygiene interventions in preventing or reducing the spread of illnesses from respiratory viruses.DESIGNUpdate of a systematic review and meta-analysis focussing on randomised controlled trials (RCTs) and cluster-RCTs (c-RCTs) evidence only.DATA SOURCESEligible trials from the previous Cochrane review, search of the Cochrane Central Register of Controlled Trials, PubMed, Embase and CINAHL from 01 October 2010 to 01 April 2020, and forward and backward citation analysis of included studies.DATA SELECTIONRCTs and c-RCTs involving people of any age, testing the use of hand hygiene methods, surface disinfection or cleaning, and other miscellaneous barrier interventions. Face masks, eye protection, and person distancing are covered in Part 1 of our systematic review. Outcomes included acute respiratory illness (ARI), influenza-like illness (ILI) or laboratory-confirmed influenza (influenza) and/or related consequences (e.g. death, absenteeism from school or work).DATA EXTRACTION AND ANALYSISSix authors working in pairs independently assessed risk of bias using the Cochrane tool and extracted data. The generalised inverse variance method was used for pooling by using the random-effects model, and results reported with risk ratios (RR) and 95% confidence intervals (CIs).RESULTSWe identified 51 eligible trials. We included 25 randomised trials comparing hand hygiene interventions with a control; 15 of these could be included in meta-analyses. We pooled 8 trials for the outcome of ARI. Hand hygiene showed a 16% relative reduction in the number of participants with ARI (RR 0.84, 95% CI 0.82 to 0.86) in the intervention group. When we considered the more strictly defined outcomes of ILI and influenza, the RR for ILI was 0.98 (95% CI 0.85 to 1.14), and for influenza the RR was 0.91 (95% CI 0.61 to 1.34). Three trials measured absenteeism. We found a 36% relative reduction in absentee numbers in the hand hygiene group (RR 0.64, 95% CI 0.58 to 0.71). Comparison of different hand hygiene interventions did not favour one intervention type over another. We found no incremental effects of combining hand hygiene with using face masks or disinfecting surfaces or objects.CONCLUSIONSDespite the lack of evidence for the impact of hand hygiene in reducing ILI and influenza, the modest evidence for reducing the burden of ARIs, and related absenteeism, justifies reinforcing the standard recommendation for hand hygiene measures to reduce the spread of respiratory viruses. Funding for relevant trials with an emphasis on adherence and compliance with such a measure is crucial to inform policy and global pandemic preparedness with confidence and precision.

ObjectivesPatients do better in research-intense environments. The importance of research is reflected in the accreditation requirements of Australian clinical specialist colleges. The nature of college-mandated research training has not been systematically explored. We examined the intended research curricula of Australian trainee doctors described by specialist colleges, their constructive alignment and the nature of scholarly project requirements.DesignWe undertook content analysis of publicly available documents to characterise college research training curricula.SettingWe reviewed all publicly accessible information from the websites of Australian specialist colleges and their subspecialty divisions. We retrieved curricula, handbooks and assessment-related documents.ParticipantsFifty-eight Australian specialist colleges and their subspecialty divisions.Primary and secondary outcome measuresTwo reviewers extracted and coded research-related activities as learning outcomes, activities or assessments, by research stage (using, participating in or leading research) and competency based on Bloom’s taxonomy (remembering, understanding, applying, analysing, evaluating, creating). We coded learning and assessment activities by type (eg, formal research training, publication) and whether it was linked to a scholarly project. Requirements related to project supervisors’ research experience were noted.ResultsFifty-five of 58 Australian college subspecialty divisions had a scholarly project requirement. Only 11 required formal research training; two required an experienced research supervisor. Colleges emphasised a role for trainees in leading research in their learning outcomes and assessments, but not learning activities. Less emphasis was placed on using research, and almost no emphasis on participation. Most learning activities and assessments mapped to the ‘creating’ domain of Bloom’s taxonomy, whereas most learning outcomes mapped to the ‘evaluating’ domain. Overall, most research learning and assessment activities were related to leading a scholarly project.ConclusionsAustralian specialist college research curricula appear to emphasise a role for trainees in leading research and producing research deliverables, but do not mandate formal research training and supervision by experienced researchers.

BackgroundPopulation trends in PSA screening and prostate cancer incidence do not perfectly correspond. We aimed to better understand relationships between trends in PSA screening, prostate cancer incidence and mortality in Australia.MethodsDescription of age standardised time trends in PSA tests, prostate biopsies, cancer incidence and mortality within Australia for the age groups: 45-74, 75-84, and 85+ years.ResultsPSA testing increased from its introduction in 1989 to a peak in 2008. It then declined in men aged 45-84 years. Prostate biopsies and cancer incidence declined from 1995 to 2000, in parallel with decrease in trans-urethral resections of prostate (TURP). After 2000, changes in biopsies and cancer incidence paralleled PSA screening in men 45-84 years, while in men ≥85 years, biopsies stabilised and incidence declined. More recently a reduction in TURP correlated with increased Dutasteride and Tamsulosin usage. Prostate cancer mortality in men aged 45-74 years remained low throughout. Mortality in men 75-84 years gradually increased until the mid 1990s, then gradually decreased. Mortality in men ≥85 years increased until the mid 1990s, then stabilised.ConclusionsAge specific prostate cancer incidence largely mirrors PSA screening rates. Most deviation may be explained by changes in management of benign prostatic disease and incidental cancer detection. The timing of the small mortality reduction in men 75-84 years is more consistent with benefits from advances in treatment than with early detection through PSA. The large increases in prostate cancer incidence with minimal changes in mortality suggest overdiagnosis.

This Viewpoint discusses the potential harms that can emerge from changing disease classifications, generally to broaden criteria for diagnosing greater numbers of patients, and calls for a balanced and systematic evaluation of the benefits and risks of shifting illness thresholds before formalizing changes.

PURPOSE Lower urinary tract symptoms are very common in older men. We conducted a systematic review and meta-analysis to evaluate the effects of self-management interventions on these symptoms. METHODS We included randomized controlled trials comparing the effect of self-management interventions (alone or combined with drug therapy) with usual care or drug therapy alone in men with lower urinary tract symptoms. Two independent reviewers screened retrieved articles, extracted data, and assessed the risk of bias of included studies. The primary outcome was lower urinary tract symptom severity. Where data were available, we calculated mean differences (MDs) between the interventions. RESULTS Analyses were based on 8 studies among 1,006 adult men. Seven of these studies were judged to be at high risk in 2 of the 7 domains of bias. The nature of the self-management interventions varied across studies. There was a clinically important reduction in the 35-point International Prostate Symptom Score at 6 months favoring self-management interventions compared with usual care (MD = –7.4; 95% CI, –8.8 to –6.1; 2 studies). The reduction in score with self-management was similar to that achieved with drug therapy at 6 to 12 weeks (MD = 0.0; 95% CI, –2.0 to 2.0; 3 studies). Self-management had a smaller, additional benefit at 6 weeks when added to drug therapy (MD = –2.3; 95% CI, –4.1 to –0.5; 1 study). CONCLUSIONS We found moderate-quality evidence (suggesting reasonable certainty in estimates) for the effectiveness of self-management for treating lower urinary tract symptoms in men. We therefore recommend the use of self-management interventions for this patient population.

Background Gestational diabetes mellitus (GDM) - a transitory form of diabetes induced by pregnancy - has potentially important short and long-term health consequences for both the mother and her baby. There is no globally agreed definition of GDM, but definition changes have increased the incidence in some countries in recent years, with some research suggesting minimal clinical improvement in outcomes. The aim of this qualitative systematic review was to identify the psychosocial experiences a diagnosis of GDM has on women during pregnancy and the postpartum period. Methods We searched CINAHL, EMBASE, MEDLINE and PsycINFO databases for studies that provided qualitative data on the psychosocial experiences of a diagnosis of GDM on women across any stage of pregnancy and/or the postpartum period. We appraised the methodological quality of the included studies using the Critical Appraisal Skills Programme Checklist for Qualitative Studies and used thematic analysis to synthesis the data. Results Of 840 studies identified, 41 studies of diverse populations met the selection criteria. The synthesis revealed eight key themes: initial psychological impact; communicating the diagnosis; knowledge of GDM; risk perception; management of GDM; burden of GDM; social support; and gaining control. The identified benefits of a GDM diagnosis were largely behavioural and included an opportunity to make healthy eating changes. The identified harms were emotional, financial and cultural. Women commented about the added responsibility (eating regimens, appointments), financial constraints (expensive food, medical bills) and conflicts with their cultural practices (alternative eating, lack of information about traditional food). Some women reported living in fear of risking the health of their baby and conducted extreme behaviours such as purging and starving themselves. Conclusion A diagnosis of GDM has wide reaching consequences that are common to a diverse group of women. Threshold cut-offs for blood glucose levels have been determined using the risk of physiological harms to mother and baby. It may also be advantageous to consider the harms and benefits from a psychosocial and a physiological perspective. This may avoid unnecessary burden to an already vulnerable population.

Background Large quantities of antimicrobials are given to food animals, particularly in feed, potentially increasing antimicrobial resistance in humans. However, the magnitude of this effect is unclear. Methods We searched PubMed, Embase and Web of Science for studies on interventions that limited antimicrobial use in food animals, in any setting and context, to reduce antimicrobial resistance 1) in those food animals; and 2) in humans. We validated our strategy by testing whether it identified known relevant studies. Data from included studies were extracted into pre-designed and pilot-tested forms. Results We included 104 articles containing 93 studies. Heterogeneity (different animal species, environs, antimicrobial classes, interventions, administration routes, sampling, and methods), was considerable, precluding meta-analysis. The evidence was therefore synthesised narratively. A total of 89 studies (3 directly, 86 indirectly) addressed whether limiting antimicrobial exposure in food animals led to decreased antimicrobial resistance in those animals. The evidence was adequate to conclude this, although the magnitude of the effect could not be quantified. Four studies (1 directly, 3 indirectly) examined whether withdrawal of antibiotics changed resistance of potential pathogens in retail food for human consumption, and in bacteria of humans themselves. The direct (observational) study of broiler hatchery in ovo antimicrobial injection found a credible effect in terms of size reduction and time sequences. Interpretation Limiting antimicrobial use in food animals reduces antimicrobial resistance in food animals, and probably reduces antimicrobial resistance in humans. The magnitude of the effect cannot be quantified.

Background Failure to sustain knowledge translation (KT) interventions impacts patients and health systems, diminishing confidence in future implementation. Sustaining KT interventions used to implement chronic disease management (CDM) interventions is of critical importance given the proportion of older adults with chronic diseases and their need for ongoing care. Our objectives are to (1) complete a systematic review and network meta-analysis of the effectiveness and cost-effectiveness of sustainability of KT interventions that target CDM for end-users including older patients, clinicians, public health officials, health services managers and policy-makers on health care outcomes beyond 1 year after implementation or the termination of initial project funding and (2) use the results of this review to complete an economic analysis of the interventions identified to be effective. Methods For objective 1, comprehensive searches of relevant electronic databases (e.g. MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials), websites of health care provider organisations and funding agencies will be conducted. We will include randomised controlled trials (RCTs) examining the impact of a KT intervention targeting CDM in adults aged 65 years and older. To examine cost, economic studies (e.g. cost, cost-effectiveness analyses) will be included. Our primary outcome will be the sustainability of the delivery of the KT intervention beyond 1 year after implementation or termination of study funding. Secondary outcomes will include behaviour changes at the level of the patient (e.g. symptom management) and clinician (e.g. physician test ordering) and health system (e.g. cost, hospital admissions). Article screening, data abstraction and risk of bias assessment will be completed independently by two reviewers. Using established methods, if the assumption of transitivity is valid and the evidence forms a connected network, Bayesian random-effects pairwise and network meta-analysis will be conducted. For objective 2, we will build a decision analytic model comparing effective interventions to estimate an incremental cost-effectiveness ratio. Discussion Our results will inform knowledge users (e.g. patients, clinicians, policy-makers) regarding the sustainability of KT interventions for CDM. Dissemination plan of our results will be tailored to end-users and include passive (e.g. publications, website posting) and interactive (e.g. knowledge exchange events with stakeholders) strategies. Systematic review registration PROSPERO CRD42018084810

Background The ubiquity of smartphones and health apps make them a potential self-management tool for patients that could be prescribed by medical professionals. However, little is known about how Australian general practitioners and their patients view the possibility of prescribing mobile health (mHealth) apps as a nondrug intervention. Objective This study aimed to determine barriers and facilitators to prescribing mHealth apps in Australian general practice from the perspective of general practitioners and their patients. Methods We conducted semistructured interviews in Australian general practice settings with purposively sampled general practitioners and patients. The audio-recorded interviews were transcribed, coded, and thematically analyzed by two researchers. Results Interview participants included 20 general practitioners and 15 adult patients. General practitioners’ perceived barriers to prescribing apps included a generational difference in the digital propensity for providers and patients; lack of knowledge of prescribable apps and trustworthy sources to access them; the time commitment required of providers and patients to learn and use the apps; and concerns about privacy, safety, and trustworthiness of health apps. General practitioners perceived facilitators as trustworthy sources to access prescribable apps and information, and younger generation and widespread smartphone ownership. For patients, the main barriers were older age and usability of mHealth apps. Patients were not concerned about privacy and data safety issues regarding health app use. Facilitators for patients included the ubiquity of smartphones and apps, especially for the younger generation and recommendation of apps by doctors. We identified evidence of effectiveness as an independent theme from both the provider and patient perspectives. Conclusions mHealth app prescription appears to be feasible in general practice. The barriers and facilitators identified by the providers and patients overlapped, though privacy was of less concern to patients. The involvement of health professionals and patients is vital for the successful integration of effective, evidence-based mHealth apps with clinical practice.

BACKGROUND The ubiquity of smartphones and health apps make them a potential self-management tool for patients that could be prescribed by medical professionals. However, little is known about how Australian general practitioners and their patients view the possibility of prescribing mobile health (mHealth) apps as a nondrug intervention. OBJECTIVE This study aimed to determine barriers and facilitators to prescribing mHealth apps in Australian general practice from the perspective of general practitioners and their patients. METHODS We conducted semistructured interviews in Australian general practice settings with purposively sampled general practitioners and patients. The audio-recorded interviews were transcribed, coded, and thematically analyzed by two researchers. RESULTS Interview participants included 20 general practitioners and 15 adult patients. General practitioners’ perceived barriers to prescribing apps included a generational difference in the digital propensity for providers and patients; lack of knowledge of prescribable apps and trustworthy sources to access them; the time commitment required of providers and patients to learn and use the apps; and concerns about privacy, safety, and trustworthiness of health apps. General practitioners perceived facilitators as trustworthy sources to access prescribable apps and information, and younger generation and widespread smartphone ownership. For patients, the main barriers were older age and usability of mHealth apps. Patients were not concerned about privacy and data safety issues regarding health app use. Facilitators for patients included the ubiquity of smartphones and apps, especially for the younger generation and recommendation of apps by doctors. We identified evidence of effectiveness as an independent theme from both the provider and patient perspectives. CONCLUSIONS mHealth app prescription appears to be feasible in general practice. The barriers and facilitators identified by the providers and patients overlapped, though privacy was of less concern to patients. The involvement of health professionals and patients is vital for the successful integration of effective, evidence-based mHealth apps with clinical practice. CLINICALTRIAL

Background Low-value arthroscopic surgery continues to be used to treat people with degenerative knee conditions (osteoarthritis, degenerative meniscal tears, loose bodies) despite consistent evidence from placebo-controlled trials and guidelines recommending against its use. Patients and some clinicians continue to harbour misconceptions about the value of this treatment modality and clinicians identify patient expectation as one key driver of arthroscopies. There is a substantial evidence base that indicates that patient decision aids increase knowledge and accuracy of perceptions about the benefits and harms of treatment options. They have been used to reduce the number of people choosing surgery in favour of more conservative options without adversely impacting on health outcomes but no decision aid focussing specifically on knee arthroscopy has been evaluated to date. Objective This study aims to evaluate the effectiveness and implementation potential of a patient decision aid for knee arthroscopy. Specifically our objectives are (i) to estimate the effectiveness and safety of a patient decision aid aimed at reducing referral for consideration of arthroscopy in people with degenerative knee disease compared with usual care; and (ii) to explore barriers and facilitators to wider implementation using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework, in order to promote future successful implementation of the decision aid in Australia. Methods We will conduct a two-arm RCT using an effectiveness-implementation hybrid trial design. This design evaluates the effects of a clinical intervention while also gathering information about its delivery and implementation. Restricted randomisation will be used to allocate participants with degenerative knee disease to intervention or control. Participants in the intervention group will receive a decision aid containing estimates of benefits and harms from our Cochrane review of knee arthroscopy and content consumers/patients have reported that they want included. The decision aid was refined after user testing with both patients and clinicians. Participants in both the intervention and control (‘usual care’) groups will receive an Arthritis Australia information sheet about osteoarthritis to control for the effect of receipt of information and enable participant blinding. Primary outcome is rate of referral for consideration of knee arthroscopy at 6 months post intervention. Outcome assessors will be blinded to group allocation. We will conduct surveys and semi-structured interviews with participants and organisations/practices involved in recruitment to explore factors perceived to influence wider implementation and sustainability. The trial will be registered in the Australian New Zealand Clinical Trials Registry (ANZCTR) before enrolment of participants and has been endorsed by the ANZMUSC Clinical Trial Network indicating its high priority and quality, importance to stakeholders, and potential to improve patient outcomes. Conclusion No decision aid focussing on knee arthroscopy has been evaluated to date. Use of a patient decision aid to address this problem is anticipated to enhance patients’ knowledge and informed choice about the benefits and harms of arthroscopy and reduce referrals for and use of arthroscopic surgery. If successful, the tool could be successfully implemented in other settings and adapted for other low-value interventions.

Objectives Current chronic kidney disease (CKD) management guidelines use absolute estimated glomerular filtration rate (eGFR) values to define stages of disease, which may lead to both overdiagnosis and underdiagnosis. An alternative is a percentile chart of kidney function (measured as eGFR) compared to age. This study examined the usefulness of this chart in General Practice to appropriately diagnose patients with declining kidney function. Methods This was a randomized controlled scenario study. A survey with questions about management of CKD was sent to a stratified, random sample of Australian General Practitioners (GPs). GPs were asked how they would diagnose and manage 2 patient cases. GPs were randomized to receive the cases either with a ‘kidney trajectory chart’ to aid in the decision making process, or initially without the chart, and then subsequently with the chart. Case 1 was an elderly woman with mild reduction in her kidney function, in the ‘3a CKD’ stage, who was in the 50th percentile for her age. Case 2 was a younger Aboriginal man who would not be considered to have kidney disease by the standard definitions, but who had kidney function in the 5th percentile for his age. Results Four hundred and seventy-two GPs participated in the study. Without the chart, GPs were unclear as to whether the case of the elderly woman with mild reduction in kidney function had a clinical problem with her kidneys (45% thought it likely, 12% were unsure, and 42% thought it unlikely), and they were similarly unclear as to whether she met the definition for disease. After viewing the kidney trajectory chart, 13% of GPs changed their opinion to indicate the patient was unlikely to have a clinical problem with her kidneys. The factor that influenced this the most was whether they could read the chart correctly. Other factors (age, length of practice, rurality, number of GPs at the practice, qualifications), did not influence this result. For case 2 (younger Aboriginal man with eGFR within the normal reference range,) without the chart, 67% of GPs thought he did not meet the definition for disease, and they were unclear about whether he had a clinical problem with his kidneys (44% thought it likely, 12% were unsure, and 44% thought it unlikely). However after viewing the chart, 39% of GPs changed their opinion to indicate he was likely to have a clinical problem with his kidneys. Again the factor that influenced this the most, was the correct interpretation of the graph. Conclusions The use of a ‘kidney trajectory chart’ in this study has shown the potential to correctly classify a patient who may have been otherwise underdiagnosed for kidney disease. It also shows the potential for preventing overdiagnosis in the case of an elderly patient with mild decline of kidney function. Further exploration of why GPs might think this type of patient doesn’t have a clinical problem with their kidneys needs to be explored.

Objective: The objective of this study was to identify key features to be addressed in the reporting of deprescribing trials and to elab-orate and explain CONSORT items in this regard.Study Design and Setting: As a first step in a multistage process and based on a systematic review of deprescribing trials, we elab-orated variation in design, intervention, and reporting of the included trials of the review. We identified items that were missed or insufficiently described, using the CONSORT and TIDieR checklists. The resulting list of items, which we considered relevant to be reported in deprescribing trials, were discussed in a single-round Delphi exercise and subsequently in a full-day face-to-face meeting with an international panel of 14 experts. We agreed on CONSORT items for further elaboration with regard to design and reporting of deprescribing trials.Results: We identified seven CONSORT items on trial design, participants, intervention, outcomes, flowchart, and harms, where the investigators of deprescribing trials should take into consideration specific aspects, such as whether or not to use placebo or how to inform participants.Conclusion: This article presents an elaboration to the CONSORT statement for the reporting of deprescribing trials. It may also support investigators in motivated design choices. (c) 2020 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

Objectives Women diagnosed with gestational diabetes mellitus (GDM) are potentially at increased risk for physical complications such as increased rates of caesarean sections, large babies, and babies with shoulder dystocia and low blood sugar. Diagnosis may offer opportunities to change behaviours yet emotional harms such as high levels of anxiety and social exclusion are widely reported by women. There is no international agreement about the testing process or the appropriate threshold of blood glucose for GDM diagnosis. In 2015, Australia adopted a new, recommended definition and testing procedure for GDM, in the absence of national consensus. Significant increases in the number of women diagnosed with GDM have been reported but with little difference in health outcomes. We explored the values and preferences of the women who may be impacted by a GDM diagnosis. Method We aimed to recruit 15 women from the Gold Coast region (Australia) and rural areas within driving distance to the Gold Coast. Eligible women were between 30 and 45 years old, had had at least one pregnancy, and no previous diagnosis of GDM. The CJ was conducted over two weekend days, 2nd and 3rd February 2019, at Bond University. Four expert presentations were conducted using voice-over powerpoint. Topics were: what is GDM, its diagnosis and treatment options; a brief history of definition changes: the Australian context; and potential consequences of GDM. Opportunity to question the experts was provided on both days. The jurors were asked to provide recommendations to two questions. In the jury’s view, which important consequences of a diagnosis of GDM should be considered by the consensus panel when discussing the Australian definition of GDM? What should Australian health practitioners call the health condition currently known as GDM? Results 116 women were contacted for 15 women to consent. Of those, 8 attended from urban and a rural setting: 3 failed to confirm and didn’t attend; 3 confirmed participants failed to attend, 1 didn’t attend due to illness. Participants’ recommendations were a consensus. Women were surprised that the level of risk for physical harms was low but emotional harms were high. Despite initially prioritising the baby’s needs, after an improved understanding of risks, women changed their preferences. The final ranking of important consequences in order of high to low importance was: negative emotions experience by women; the burden of managing GDM; over-medicalised pregnancy; opportunity to minimise the risks to the baby; opportunity to improve lifestyle; and macrosomia. To describe the four different clinical states of GDM, and to minimise the potential harms of the GDM diagnostic label, the jurors chose three different labels. Only one was GDM. Conclusions Clinicians report that anecdotally, women diagnosed with GDM will always put their babies needs before their own. Although smaller than anticipated, this CJ demonstrated that a group of women informed about the evidence of likelihood of the potential consequences of GDM, recognised the negative emotional consequences to themselves was of greatest concern. The current glucose threshold for GDM in Australia is set at a cut-point for an adverse risks including macrosomia and neonatal hyperinsulemia. When informed about the level of risk to women and babies, the CJ participants ranked macrosomia as the last priority. Only one of the eight women identified macrosomia as an important risk. It is essential we reconsider how new definitions of diseases are made, as clinicians do not attribute women’s priorities accurately, nor do they ask informed women. It is time for community voices impacted by these decisions to be embedded in the decision-making.

Changing disease or health risk definitions and labels where there is a case for no or little net benefit and significant harm, has the potential to affect millions of people worldwide. It appears, on the surface, to be a comparatively sustainable intervention to mitigate overdiagnosis and overtreatment, requiring only a one-off policy change. In practice however, changing disease definitions is an intensely complex, personal and political process requiring buy-in from clinical groups, patients and citizens. This symposium examines how changing disease/health risk definitions and labels might mitigate overdiagnosis and overtreatment. Taking a multidisciplinary perspective we consider how Psychology, Epidemiology, Deliberative engagement, Bioethics and History and Philosophy of science can contribute to our understanding of the impact of disease/risk definitions and labels on citizens, the health system and society in general. We identify possible solutions for this growing problem, including examining how this might be implemented by decision-makers responsible for defining conditions. We will have a series of brief 5 minute presentations followed by general discussion to collectively identify and further develop strategies to achieve change where it is warranted. Program of speakers (45 minutes) Introduction – Professor Kirsten McCaffery, University of Sydney. The Consumer’s view – TBC The problem The impacts of names on the named - a historical and philosophical perspective on disease definitions and labels – Dr Chris Degeling, University of Wollongong. Using Psychological methods to understand the impact of disease or disease risk labels and the effect of changing labels: Evidence from cancer labelling studies – Dr Brooke Nickel, University of Sydney Evidence from non-cancer labelling studies – Tessa Copp, University of Sydney Possible solutions Engaging patients and public about the definition of conditions– Professor Stacy Carter, University of Wollongong. Re-labelling Gestational Diabetes: what do consumers want? A/Prof Rae Thomas, University of Bond. Defining the thresholds and boundaries for disease through expert committees. A proposed model for reform – Dr Ray Moynihan, Bond University. Changing practice in setting disease definitions through the Guidelines International Network – Professors Jenny Doust/Paul Glasziou, Bond University.

Objectives Heart age calculators are increasingly popular around the world as a way to promote and communicate cardiovascular disease (CVD) risk assessment to patients/consumers. While they have intuitive appeal, the implicit assumptions behind heart age calculator algorithms have important implications for informed decision making and screening programs. This presentation compares the use of heart age in three countries to illustrate potential problems for disease mongering and inadvertently expanding screening programs, and how to avoid these problems. Methods Analysis of the use of heart age calculators to promote CVD prevention guidelines in the UK, New Zealand and Australia; including content analysis of social media reactions amongst the general public and health professional communities to demonstrate potential problems. Results The different approaches to heart age in different countries illustrates how some design decisions and message targeting can lead to inadvertent harm, in terms of scaring/medicalising low risk people and expanding screening. A recent heart age campaign in the UK caused a backlash from GPs for encouraging cholesterol testing in young people, and led to confusion amongst the 80% of users who received older heart age results and medication recommendations. Apart from being a test for an ‘important health problem’, the Heart Age calculator met none of Public Health England’s own assessment criteria for a potentially useful screening test. In contrast, New Zealand’s heart age calculator has been aimed at GPs with clear explanations of absolute risk that reduce the chance of harm; while Australia is currently trialling a consumer-driven approach that may encourage more testing but avoids explicit medication recommendations. Conclusions This analysis shows how some features of heart age calculators may lead to harms, and how to avoid them. We recommend that the results of heart age calculators should explicitly explain how they relate to the absolute risk of a CVD event, and avoid making recommendations for medication or tests for age groups beyond existing screening programs. When used to encourage younger people to seek unnecessary cholesterol and blood pressure tests, or recommend medication to people at low risk of a heart attack or stroke based on older heart age, they may cause more harm than benefit.

Objectives The aim of this study was to evaluate how often the European Medicines Agency (EMA) has authorized drugs based on nonrandomized studies and whether there is an association between treatment effects and EMA preference for further testing in randomized clinical trials (RCTs). Study Design and Setting We reviewed all initial marketing authorizations in the EMA database on human medicines between 1995 and 2015 and included authorizations granted without randomized data. We extracted data on treatment effects and EMA preference for further testing in RCTs. Results Of 723 drugs, 51 were authorized based on nonrandomized data. These 51 drugs were licensed for 71 indications. In the 51 drug-indication pairs with no preference for further RCT testing, effect estimates were large [odds ratio (OR): 12.0 (95% confidence interval {CI}: 8.1–17.9)] compared to effect estimates in the 20 drug-indication pairs for which future RCTs were preferred [OR: 4.3 (95% CI 2.8–6.6)], with a significant difference between effects (P = 0.0005). Conclusion Nonrandomized data were used for 7% of EMA drug approvals. Larger effect sizes were associated with greater likelihood of approval based on nonrandomized data alone. We did not find a clear treatment effect threshold for drug approval without RCT evidence.

The objective of this study was to determine whether habit-based interventions are clinically beneficial in achieving long-term (12-month) weight loss maintenance and explore whether making new habits or breaking old habits is more effective. Volunteer community members aged 18–75 years who had overweight or obesity (BMI ≥ 25 kg/m2) were randomized in a single-blind, three-arm, randomized controlled trial. Ten Top Tips (TTT), Do Something Different (DSD), and the attention-only waitlist (WL) control groups were conducted for 12 weeks from July to October 2015. Participants were followed up post-intervention (all groups) and at 6 and 12-month post-intervention (Ten Top Tips and Do Something Different only). The primary outcome was weight-loss maintenance at 12-month follow-up. Secondary outcomes included weight loss at all time points, fruit and vegetable consumption, exercise, wellbeing, depression, anxiety, habit strength, and openness to change. Of the 130 participants assessed for eligibility, 75 adults (mean BMI 34.5 kg/m2 [SD 6.2]), with a mean age of 51 years were recruited. Assessments were completed post-intervention by 66/75 (88%) of participants and by 43/50 (86%) at 12 months. At post-intervention, participants in the Ten Top Tips (−3.3 kg; 95% CI −5.2, −1.4) and Do Something Different (−2.9 kg; 95% CI −4.3, −1.4) interventions lost significantly more weight (P =

Objectives The objective of the study was to identify the critical factors that determine recommendations and other decisions about healthcare-related tests and diagnostic strategies (HCTDS). Methods We used a qualitative descriptive approach and conducted semi-structured in-depth interviews with 24 international experts (informants) in evidence and decisions about HCTDS. Results Although test accuracy (TA) was the factor most commonly considered by organizations when developing recommendations about HCTDS, informants agreed that TA is necessary but rarely, if ever, sufficient and may be misleading when solely considered. The informants identified factors that are important for developing recommendations about HCTDS. Informants largely agreed that laying out the potential care pathways based on the test result is an essential early step but is rarely done in developing recommendations about HCTDS. Most informants also agreed that decision analysis could be useful for organizing the clinical, cost, and preference data relevant to the use of tests in the absence of direct evidence. However, they noted that using models is limited by the lack of resources and expertise required. Conclusion Developing guidelines about HCTDS requires consideration of factors beyond TA, but implementing this may be challenging. Further development and testing of “frameworks” that can guide this process is a priority for decision makers.

Context Complete reporting of intervention details in trials of evidence-based practice (EBP) educational interventions is essential to enable clinical educators to translate research evidence about interventions that have been shown to be effective into practice. In turn, this will improve the quality of EBP education. Objectives This study was designed to examine the completeness of reporting of EBP educational interventions in published studies and to assess whether missing details of educational interventions could be retrieved by searching additional sources and contacting study authors. Methods A systematic review of controlled trials that had evaluated EBP educational interventions was conducted using a citation analysis technique. Forward and backward citations of the index articles were tracked until March 2016. The TIDieR (template for intervention description and replication) checklist was used to assess the completeness of intervention reporting. Missing details were sought from: (i) the original publication; (ii) additional publicly available sources, and (iii) the study authors. Results Eighty-three articles were included; 45 (54%) were randomised controlled trials (RCTs) and 38 (46%) were non-RCTs. The majority of trials (n = 62, 75%) involved medical professionals. None of the studies completely reported all of the main items of the educational intervention within the original publication or in additional sources. However, details became complete for 17 (20%) interventions after contact with the respective authors. The item most frequently missing was ‘intervention materials’, which was missing in 80 (96%) of the original publications, in additional sources for 77 (93%) interventions, and in 59 (71%) studies after contact with the authors. Authors of 69 studies were contacted; 33 provided the details requested. Conclusions The reporting of EBP educational interventions is incomplete and remained so for the majority of studies, even after study authors had been contacted for missing information. Collaborative efforts involving authors and editors are required to improve the completeness of reporting of EBP educational interventions.

New approaches to evidence synthesis, which use human effort and machine automation in mutually reinforcing ways, can enhance the feasibility and sustainability of living systematic reviews. Human effort is a scarce and valuable resource, required when automation is impossible or undesirable, and includes contributions from online communities (“crowds”) as well as more conventional contributions from review authors and information specialists. Automation can assist with some systematic review tasks, including searching, eligibility assessment, identification and retrieval of full-text reports, extraction of data, and risk of bias assessment. Workflows can be developed in which human effort and machine automation can each enable the other to operate in more effective and efficient ways, offering substantial enhancement to the productivity of systematic reviews. This paper describes and discusses the potential—and limitations—of new ways of undertaking specific tasks in living systematic reviews, identifying areas where these human/machine “technologies” are already in use, and where further research and development is needed. While the context is living systematic reviews, many of these enabling technologies apply equally to standard approaches to systematic reviewing.

Overuse, which is defined as the provision of medical services that are more likely to cause harm than good, is a pervasive problem. Direct measurement of overuse through documentation of delivery of inappropriate services is challenging given the difficulty of defining appropriate care for patients with individual preferences and needs; overuse can also be measured indirectly through examination of unwarranted geographical variations in prevalence of procedures and care intensity. Despite the challenges, the high prevalence of overuse is well documented in high-income countries across a wide range of services and is increasingly recognised in low-income countries. Overuse of unneeded services can harm patients physically and psychologically, and can harm health systems by wasting resources and deflecting investments in both public health and social spending, which is known to contribute to health. Although harms from overuse have not been well quantified and trends have not been well described, overuse is likely to be increasing worldwide.

Background Clinicians are encouraged to use guidelines to assist in providing evidence-based secondary prevention to patients with coronary heart disease. However, the expanding number of publications providing guidance about exercise training may confuse cardiac rehabilitation clinicians. We therefore sought to explore the number, scope, publication characteristics, methodological quality, and clinical usefulness of published exercise-based cardiac rehabilitation guidance. Methods We included publications recommending physical activity, exercise or cardiac rehabilitation for patients with coronary heart disease. These included systematically developed clinical practice guidelines, as well as other publications intended to support clinician decision making, such as position papers or consensus statements. Publications were obtained via electronic searches of preventive cardiology societies, guideline databases and PubMed, to November 2016. Publication characteristics were extracted, and two independent assessors evaluated quality using the 23-item Appraisal of Guidelines Research and Evaluation II (AGREE) tool. Results Fifty-four international publications from 1994 to 2016 were identified. Most were found on preventive cardiology association websites (n = 35; 65%) and were freely accessible (n = 50; 93%). Thirty (56%) publications contained only broad recommendations for physical activity and cardiac rehabilitation referral, while 24 (44%) contained the necessary detailed exercise training recommendations. Many were labelled as “guidelines”, however publications with other titles (e.g. scientific statements) were common (n = 24; 44%). This latter group of publications contained a significantly greater proportion of detailed exercise training recommendations than clinical guidelines (p = 0.017). Wide variation in quality also existed, with ‘applicability’ the worst scoring AGREE II domain for clinical guidelines (mean score 53%) and ‘rigour of development’ rated lowest for other guidance types (mean score 33%). Conclusions While a large number of guidance documents provide recommendations for exercise-based cardiac rehabilitation, most have limitations in either methodological quality or clinical usefulness. The lack of rigorously developed guidelines which also contain necessary detail about exercise training remains a substantial problem for clinicians. Electronic supplementary material The online version of this article (doi:10.1186/s12872-017-0589-z) contains supplementary material, which is available to authorized users.

Our primary purpose was to assess the clinical (predictive) validity of central retinal thickness (CRT) and best corrected visual acuity (BCVA) at 1 week and 1 month after starting treatment with ranibizumab for central retinal vein occlusion. The authors also assessed detectability of response to treatment.The authors used data from 325 participants in the CRUISE study, which included measurement of time-domain CRT and BCVA at baseline, 1 week, 1 month, and 6 months postrandomization. Analysis of covariance models were fitted to assess clinical validity, and distributions of change were constructed to assess detectability of response.There was no evidence that 1-week CRT, and very strong evidence that 1-week BCVA were associated with baseline-adjusted BCVA at 6 months (P = 0.17 and P < 0.001, respectively). There was strong evidence that both 1-month CRT and 1-month BCVA were associated with baseline-adjusted 6-month BCVA (P = 0.005 and P < 0.001, respectively), but simultaneous adjustment found evidence of independent association only for BCVA (P = 0.71 and P < 0.001 for CRT and BCVA, respectively). Detectability of response tended to be higher for CRT than BCVA at 1 week and 1 month but by 6 months these were equivalent for CRT and BCVA.In this study, BCVA monitoring of treated central retinal vein occlusion patients seemed more informative than time-domain optical coherence tomography monitoring.