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Abstract Background Chronic kidney disease (CKD) is commonly managed in general practice, with established guidelines for diagnosis and management. CKD is more prevalent in the older population, and is associated with lifestyle diseases as well as social deprivation. Older patients also commonly experience multimorbidity. Current CKD guidelines do not take age into account, with the same diagnostic and management recommendations for patients regardless of their age. We sought to investigate general practitioners’ (GPs’) approach to older patients with CKD, and whether their assessment and management differed from guideline recommendations. We explored the reasons for variation from guideline recommendations. Methods This was a mixed methods study of Australian GPs. An online anonymous survey about the use of CKD guidelines, and assessment and management of CKD was sent to 9500 GPs. Four hundred and sixty-nine (5%) of GPs responded, and the survey was completed by 399 GPs. Subsequently, 27 GPs were interviewed in detail about their diagnostic and management approach to older patients with declining kidney function. Results In the survey, 48% of GPs who responded found the CKD guidelines useful for diagnosis and management. Four themes arose from our interviews: age-related decline in kidney function; whole person care; patient-centred care; and process of care that highlighted the importance of continuity of care. GPs recognised that older patients have an inherently high risk of lower kidney function. The GPs reported management of that higher risk focused on managing the whole person (not just a single disease focus) and being patient-centred. Patient-centred care expressed the importance of quality of life, shared decision making and being symptom focused. There was also a recognition that there is a difference between a sudden decline in kidney function and a stable but low kidney function and GPs would manage these situations differently. Conclusions GPs apply guidelines in the management of CKD in older patients using a patient-centred and whole person approach to care. Older patients have a high prevalence of multimorbidity, which GPs carefully considered when applying existing CKD-specific guidelines. Future iterations of CKD Guidelines need to give due consideration to multimorbidity in older patients that can adversely impact on kidney function in addition to the expected age-related functional decline.

Introduction Many types of prostate cancer present minimal risk to a man’s lifespan or well-being, but existing terminology makes it difficult for men to distinguish these from high-risk prostate cancers. This study aims to explore whether using an alternative label for low-risk prostate cancer influences management choice and anxiety levels among Australian men and their partners.Methods and analysis We will run two separate studies for Australian men and Australian women with a male partner. Both studies are between-subjects factorial (3×2) randomised online hypothetical experiments. Following consent, eligible participants will be randomised 1:1:1 to three labels: ‘low-risk prostate cancer, Gleason Group 1’, ‘low-risk prostate neoplasm’ or ‘low-risk prostate lesion’. Participants will then undergo a second randomisation step with 1:1 allocation to the provision of detailed information on the benefits and harms of different management choices versus the provision of less detailed information about management choices. The required sample sizes are 1290 men and 1410 women. The primary outcome is the participant choice of their preferred management strategy: no immediate treatment (prostate-specific antigen (PSA)-based monitoring or active surveillance using PSA, MRI, biopsy with delayed treatment for disease progression) versus immediate treatment (prostatectomy or radiation therapy). Secondary outcomes include preferred management choice (from the four options listed above), diagnosis anxiety, management choice anxiety and management choice at a later time point (for participants who initially choose a monitoring strategy).Ethics and dissemination Ethics approval has been received from The University of Sydney Human Research Ethics Committee (2023/572). The results of the study will be published in a peer-reviewed medical journal and a plain language summary of the findings will be shared on the Wiser Healthcare publications page http://www.wiserhealthcare.org.au/category/publications/Trial registration numbers Australian New Zealand Clinical Trials Registry (ID 386701 and 386889).

Background: The stages of chronic kidney disease (CKD) and estimated glomerular filtration rate (eGFR) reference ranges are currently determined without considering age. Aim: To determine whether a chart that graphs age with eGFR helps GPs make better decisions about managing patients with declining eGFR. Design & setting: A randomised controlled vignette study among Australian GPs using a percentile chart plotting the trajectory of eGFR by age. Method: Three hundred and seventy-three GPs received two case studies of patients with declining renal function. They were randomised to receive the cases with the chart or without the chart, and asked a series of questions about how they would manage the cases. Results: In an older female patient with stable but reduced kidney function, use of the chart was associated with GPs in the study recommending a longer follow-up period, and longer time until repeat pathology testing. In a younger male First Nations patient with normal but decreasing kidney function, use of the chart was associated with GPs in the study recommending a shorter follow-up period, shorter time to repeat pathology testing, increased management of blood pressure and lifestyle, and avoidance of nephrotoxic medications. This represents more appropriate care in both cases. Conclusion: Having access to a chart of percentile eGFR by age was associated with more appropriate management review periods of patients with reduced kidney function, either by greater compliance with current guidelines or greater awareness of a clinically relevant kidney problem.

ObjectivesChronic kidney disease (CKD) affects up to 11% of the population. General practice is at the forefront of the identification of patients with declining kidney function, and appropriate monitoring and management of patients with CKD. An individualized and patient-centred approach is currently recommended in guidelines, but would be enhanced by more detailed guidance on how this should be applied to different age groups, such as use of a kidney trajectory chart. We explored the opinion of general practitioners (GPs) about the potential utility of kidney trajectory charts.MethodsQualitative study interviewing 27 Australian GPs about their management of chronic kidney disease. GPs were presented with charts that plotted percentiles of kidney function (eGFR) with age and discussed how they would use the charts manage to patients with declining kidney function. GPs' opinion was sought as to how useful these charts might be in clinical practice.ResultsMost GPs were positive about the use of kidney trajectory charts to assist them with recognition and management of declining kidney function in general practice: e.g, comments included a "valuable tool", "a bit of an eye opener"," will help me explain to the patients", "I'll stick it on my wall.". GPs responded that the charts could help monitor patients, trigger early recognition of a younger patient at risk, and assist with older patients to determine when treatment may not be warranted. GPs also thought that charts could also be useful to motivate patients and help them monitor their own condition.ConclusionsUse of percentile charts in conjunction with the current CKD guidelines help support a patient-centred model of care. Kidney trajectory charts can help patients to understand their risk of further kidney damage or decline. Research on the use of these charts in clinical practice should be undertaken to further develop their use.

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.

Background Many guidelines recommend non-drug interventions (NDIs) for managing common conditions in primary care. However, compared with drug interventions, NDIs are less widely known, promoted and used. We aim to (1) examine general practitioners’ (GPs’) knowledge, attitudes and practices for NDIs, including their use of the Royal Australian College of General Practitioners (RACGP) Handbook of Non-Drug Interventions (HANDI), and (2) identify factors influencing their use of NDIs and HANDI.Methods We conducted a web-based cross-sectional survey of practicing GP members in Australia during October–November 2022. The survey contained five sections: characteristics of GP; knowledge and use of NDIs; attitudes towards NDIs; barriers and enablers to using HANDI; and suggestions of NDIs and ideas to improve the uptake of NDIs in primary care.Results Of the 366 GPs who completed the survey, 242 (66%) were female, and 248 (74%) were ≥45 years old. One in three GPs reported that they regularly (‘always’) recommend NDIs to their patients when appropriate (34%), whereas one-third of GPs were unaware of HANDI (39%). GPs identified several factors that improve the uptake of HANDI, including ‘access and integration of HANDI in clinical practice’, ‘content and support to use in practice’ and ‘awareness and training’.Conclusions While many GPs are aware of the effectiveness of NDIs and often endorse their use, obstacles still prevent widespread adoption in primary care. The results of this survey can serve as a foundation for developing implementation strategies to improve the uptake of effective evidence-based NDIs in primary care.

BackgroundTelehealth has been used for health care delivery for decades, but the COVID-19 pandemic greatly accelerated the uptake of telehealth in many care settings globally. However, few studies have carried out a direct comparison among different telehealth modalities, with very few studies having compared the effectiveness of telephone and video telehealth modalities. ObjectiveThis study aimed to identify and synthesize randomized controlled trials (RCTs) comparing synchronous telehealth consultations delivered by telephone and those conducted by video with outcomes such as clinical effectiveness, patient safety, cost-effectiveness, and patient and clinician satisfaction with care. MethodsPubMed (MEDLINE), Embase, and CENTRAL were searched via the Cochrane Library from inception until February 10, 2023, for RCTs without any language restriction. Forward and backward citation searches were conducted on included RCTs. The Cochrane Risk of Bias 2 tool was used to assess the quality of the studies. We included studies carried out in any health setting—involving all types of outpatient cohorts and all types of health care providers—that compared synchronous video consultations directly with telephone consultations and reported outcomes specified in the objective. We excluded studies of clinician-to-clinician telehealth consults, hospitalized patients, and asynchronous consultations. ResultsSixteen RCTs—10 in the United States, 3 in the United Kingdom, 2 in Canada, and 1 in Australia involving 1719 participants—were included in the qualitative and quantitative analyses. Most of the telehealth interventions were for hospital-based outpatient follow-ups, monitoring, and rehabilitation (n=13). The 3 studies that were conducted in the community all focused on smoking cessation. In half of the studies, nurses delivered the care (n=8). Almost all included studies had high or unclear risk of bias, mainly due to bias in the randomization process and selection of reported results. The trials found no substantial differences between telephone and video telehealth consultations with regard to clinical effectiveness, patient satisfaction, and health care use (cost-effectiveness) outcomes. None of the studies reported on patient safety or adverse events. We did not find any study on telehealth interventions for diagnosis, initiating new treatment, or those conducted in a primary care setting. ConclusionsBased on a small set of diverse trials, we found no notable differences between telephone and video consultations for the management of patients with an established diagnosis. There is also a significant lack of telehealth research in primary care settings despite its high uptake.

Abstract Background Prioritisation of clinical trials ensures that the research conducted meets the needs of stakeholders, makes the best use of resources and avoids duplication. The aim of this review was to identify and critically appraise approaches to research prioritisation applicable to clinical trials, to inform best practice guidelines for clinical trial networks and funders. Methods A scoping review of English-language published literature and research organisation websites (January 2000 to January 2020) was undertaken to identify primary studies, approaches and criteria for research prioritisation. Data were extracted and tabulated, and a narrative synthesis was employed. Results Seventy-eight primary studies and 18 websites were included. The majority of research prioritisation occurred in oncology and neurology disciplines. The main reasons for prioritisation were to address a knowledge gap (51 of 78 studies [65%]) and to define patient-important topics (28 studies, [35%]). In addition, research organisations prioritised in order to support their institution’s mission, invest strategically, and identify best return on investment. Fifty-seven of 78 (73%) studies used interpretative prioritisation approaches (including Delphi surveys, James Lind Alliance and consensus workshops); six studies used quantitative approaches (8%) such as prospective payback or value of information (VOI) analyses; and 14 studies used blended approaches (18%) such as nominal group technique and Child Health Nutritional Research Initiative. Main criteria for prioritisation included relevance, appropriateness, significance, feasibility and cost-effectiveness. Conclusion Current research prioritisation approaches for groups conducting and funding clinical trials are largely interpretative. There is an opportunity to improve the transparency of prioritisation through the inclusion of quantitative approaches.

Objective To determine the effect of covid-19 vaccination, given before and after acute infection with the SARS-CoV-2 virus, or after a diagnosis of long covid, on the rates and symptoms of long covid.Design Systematic review.Data sources PubMed, Embase, and Cochrane covid-19 trials, and Europe PubMed Central (Europe PMC) for preprints, from 1 January 2020 to 3 August 2022.Eligibility criteria for selecting studies Trials, cohort studies, and case-control studies reporting on patients with long covid and symptoms of long covid, with vaccination before and after infection with the SARS-CoV-2 virus, or after a diagnosis of long covid. Risk of bias was assessed with the ROBINS-I tool.Results 1645 articles were screened but no randomised controlled trials were found. 16 observational studies from five countries (USA, UK, France, Italy, and the Netherlands) were identified that reported on 614 392 patients. The most common symptoms of long covid that were studied were fatigue, cough, loss of sense of smell, shortness of breath, loss of taste, headache, muscle ache, difficulty sleeping, difficulty concentrating, worry or anxiety, and memory loss or confusion. 12 studies reported data on vaccination before infection with the SARS-CoV-2 virus, and 10 showed a significant reduction in the incidence of long covid: the odds ratio of developing long covid with one dose of vaccine ranged from 0.22 to 1.03; with two doses, odds ratios were 0.25-1; with three doses, 0.16; and with any dose, 0.48-1.01. Five studies reported on vaccination after infection, with odds ratios of 0.38-0.91. The high heterogeneity between studies precluded any meaningful meta-analysis. The studies failed to adjust for potential confounders, such as other protective behaviours and missing data, thus increasing the risk of bias and decreasing the certainty of evidence to low.Conclusions Current studies suggest that covid-19 vaccines might have protective and therapeutic effects on long covid. More robust comparative observational studies and trials are needed, however, to clearly determine the effectiveness of vaccines in preventing and treating long covid.Protocol registration Open Science Framework https://osf.io/e8jdy.

Introduction Consistent evidence shows pathology services are overused worldwide and that about one-third of testing is unnecessary. Audit and feedback (AF) is effective for improving care but few trials evaluating AF to reduce pathology test requesting in primary care have been conducted. The aim of this trial is to estimate the effectiveness of AF for reducing requests for commonly overused pathology test combinations by high-requesting Australian general practitioners (GPs) compared with no intervention control. A secondary aim is to evaluate which forms of AF are most effective.Methods and analysis This is a factorial cluster randomised trial conducted in Australian general practice. It uses routinely collected Medicare Benefits Schedule data to identify the study population, apply eligibility criteria, generate the interventions and analyse outcomes. On 12 May 2022, all eligible GPs were simultaneously randomised to either no intervention control or to one of eight intervention groups. GPs allocated to an intervention group received individualised AF on their rate of requesting of pathology test combinations compared with their GP peers. Three separate elements of the AF intervention will be evaluated when outcome data become available on 11 August 2023: (1) invitation to participate in continuing professional development-accredited education on appropriate pathology requesting, (2) provision of cost information on pathology test combinations and (3) format of feedback. The primary outcome is the overall rate of requesting of any of the displayed combinations of pathology tests of GPs over 6 months following intervention delivery. With 3371 clusters, assuming no interaction and similar effects for each intervention, we anticipate over 95% power to detect a difference of 4.4 requests in the mean rate of pathology test combination requests between the control and intervention groups.Ethics and dissemination Ethics approval was received from the Bond University Human Research Ethics Committee (#JH03507; approved 30 November 2021). The results of this study will be published in a peer-reviewed journal and presented at conferences. Reporting will adhere to Consolidated Standards of Reporting Trials.Trial registration number ACTRN12622000566730.

Background and aimsHigh quality clinical research that addresses important questions requires significant resources. In resource-constrained environments, projects will therefore need to be prioritized. The Australia and New Zealand Musculoskeletal (ANZMUSC) Clinical Trials Network aimed to develop a stakeholder-based, transparent, easily implementable tool that provides a score for the 'importance' of a research question which could be used to rank research projects in order of importance.MethodsUsing a mixed-methods, multi-stage approach that included a Delphi survey, consensus workshop, inter-rater reliability testing, validity testing and calibration using a discrete-choice methodology, the Research Question Importance Tool (ANZMUSC-RQIT) was developed. The tool incorporated broad stakeholder opinion, including consumers, at each stage and is designed for scoring by committee consensus.ResultsThe ANZMUSC-RQIT tool consists of 5 dimensions (compared to 6 dimensions for an earlier version of RQIT): (1) extent of stakeholder consensus, (2) social burden of health condition, (3) patient burden of health condition, (4) anticipated effectiveness of proposed intervention, and (5) extent to which health equity is addressed by the research. Each dimension is assessed by defining ordered levels of a relevant attribute and by assigning a score to each level. The scores for the dimensions are then summed to obtain an overall ANZMUSC-RQIT score, which represents the importance of the research question. The result is a score on an interval scale with an arbitrary unit, ranging from 0 (minimal importance) to 1000. The ANZMUSC-RQIT dimensions can be reliably ordered by committee consensus (ICC 0.73-0.93) and the overall score is positively associated with citation count (standardised regression coefficient 0.33, pConclusionWe propose that the ANZMUSC-RQIT is a useful tool for prioritising the importance of a research question.

Objective Reporting guidelines can improve dissemination and application of findings and help avoid research waste. Recent studies reveal opportunities to improve primary care (PC) reporting. Despite increasing numbers of guidelines, none exists for PC research. This study aims to prioritise candidate reporting items to inform a reporting guideline for PC research.Design Delphi study conducted by the Consensus Reporting Items for Studies in Primary Care (CRISP) Working Group.Setting International online survey.Participants Interdisciplinary PC researchers and research users.Main outcome measures We drew potential reporting items from literature review and a series of international, interdisciplinary surveys. Using an anonymous, online survey, we asked participants to vote on and whether each candidate item should be included, required or recommended in a PC research reporting guideline. Items advanced to the next Delphi round if they received>50% votes to include. Analysis used descriptive statistics plus synthesis of free-text responses.Results 98/116 respondents completed round 1 (84% response rate) and 89/98 completed round 2 (91%). Respondents included a variety of healthcare professions, research roles, levels of experience and all five world regions. Round 1 presented 29 potential items, and 25 moved into round 2 after rewording and combining items and adding 2 new items. A majority of round 2 respondents voted to include 23 items (90%–100% for 11 items, 80%–89% for 3 items, 70%–79% for 3 items, 60%–69% for 3 items and 50%–59% for 3 items).Conclusion Our Delphi study identified items to guide the reporting of PC research that has broad endorsement from the community of producers and users of PC research. We will now use these results to inform the final development of the CRISP guidance for reporting PC research.

Abstract Background The effect of eye protection to prevent SARS-CoV-2 infection in the real-world remains uncertain. We aimed to synthesize all available research on the potential impact of eye protection on transmission of SARS-CoV-2. Methods We searched PROSPERO, PubMed, Embase, The Cochrane Library for clinical trials and comparative observational studies in CENTRAL, and Europe PMC for pre-prints. We included studies that reported sufficient data to estimate the effect of any form of eye protection including face shields and variants, goggles, and glasses, on subsequent confirmed infection with SARS-CoV-2. Results We screened 898 articles and included 6 reports of 5 observational studies from 4 countries (USA, India, Columbia, and United Kingdom) that tested face shields, goggles, and wraparound eyewear on 7567 healthcare workers. The three before-and-after and one retrospective cohort studies showed statistically significant and substantial reductions in SARS-CoV-2 infections favouring eye protection with odds ratios ranging from 0.04 to 0.6, corresponding to relative risk reductions of 96% to 40%. These reductions were not explained by changes in the community rates. However, the one case–control study reported odds ratio favouring no eye protection (OR 1.7, 95% CI 0.99, 3.0). The high heterogeneity between studies precluded any meaningful meta-analysis. None of the studies adjusted for potential confounders such as other protective behaviours, thus increasing the risk of bias, and decreasing the certainty of evidence to very low. Conclusions Current studies suggest that eye protection may play a role in prevention of SARS-CoV-2 infection in healthcare workers. However, robust comparative trials are needed to clearly determine effectiveness of eye protections and wearability issues in both healthcare and general populations.

Background. Overdiagnosis is an accepted harm of cancer screening, but studies of prostate cancer screening decision aids have not examined provision of information important in communicating the risk of overdiagnosis, including overdiagnosis frequency, competing mortality risk, and the high prevalence of indolent cancers in the population. Methods. We undertook a comprehensive review of all publicly available decision aids for prostate cancer screening, published in (or translated to) the English language, without date restrictions. We included all decision aids from a recent systematic review and screened excluded studies to identify further relevant decision aids. We used a Google search to identify further decision aids not published in peer reviewed medical literature. Two reviewers independently screened the decision aids and extracted information on communication of overdiagnosis. Disagreements were resolved through discussion or by consulting a third author. Results. Forty-one decision aids were included out of the 80 records identified through the search. Most decision aids ( n = 32, 79%) did not use the term overdiagnosis but included a description of it ( n = 38, 92%). Few ( n = 7, 17%) reported the frequency of overdiagnosis. Little more than half presented the benefits of prostate cancer screening before the harms ( n = 22, 54%) and only 16, (39%) presented information on competing risks of mortality. Only 2 ( n = 2, 5%) reported the prevalence of undiagnosed prostate cancer in the general population. Conclusion. Most patient decision aids for prostate cancer screening lacked important information on overdiagnosis. Specific guidance is needed on how to communicate the risks of overdiagnosis in decision aids, including appropriate content, terminology and graphical display. Highlights Most patient decision aids for prostate cancer screening lacks important information on overdiagnosis. Specific guidance is needed on how to communicate the risks of overdiagnosis.

Abstract Background Current guidelines recommend that patients attending general practice should be screened for excess weight, and provided with weight management advice. Objective This study sought to elicit the views of people with overweight and obesity about the role of GPs in initiating conversations about weight management. Methods Participants with a body mass index ≥25 were recruited from a region in Australia to take part in a Community Jury. Over 2 days, participants (n = 11) deliberated on two interconnected questions: ‘Should GPs initiate discussions about weight management?’ And ‘if so, when: (a) opportunistically, (b) in the context of disease prevention, (c) in the context of disease management or (d) other?’ The jury deliberations were analysed qualitatively to elicit their views and recommendations. Results The jury concluded GPs should be discussing weight management, but within the broader context of general health. The jury were divided about the utility of screening. Jurors felt GPs should initiate the conversation if directly relevant for disease prevention or management, otherwise GPs should provide opportunities for patients to consent to the issue being raised. Conclusion The jury's verdict suggests informed people affected by overweight and obesity believe GPs should discuss weight management with their patients. GPs should feel reassured that discussions are likely to be welcomed by patients, particularly if embedded within a more holistic focus on person‐centred care. Public contribution Members of the public took part in the conduct of this study as jurors, but were not involved in the design, analysis or write‐up.

Thromboembolic events are a common risk in adults with atrial fibrillation, those with previous cerebrovascular accidents and undergoing emergency or elective surgeries. The widespread availability of antithrombotic agents and differing guidelines contribute to practice variations and increased risk of complications and deaths. The objective of this review was to investigate the extent of overuse and underuse of antithrombotics for primary or secondary prevention as measured by deviation from prescribing guideline recommendations. We conducted a systematic review of Medline and EMBASE for quantitative articles published between 2000 and 2021 and used a modified version of the Hoy’s risk of bias assessment tool. Here we report evidence from the past decade about wide practice variations in hospitals and primary care, and discuss clinician and patient-driven determinants of non-adherence to guidelines. Finally, we summarise implications for practice, identify enhanced ways of measuring overuse and underuse, and propose potential solutions to the measurement challenges.

Abstract Purpose of this letter was to explore the trends regarding methodological flaws of systematic review and meta-analyses (SRMAs) based on retraction notes in the past decades, and the categories of reasons for the retractions. Content analysis with descriptive statistics, Cochran Q test, and multinomial logistic regression were used. Based on 187 records of retracted SRMAs, retraction announcements can be categorized into academic ethical violation, methodological flaw, and writing or reporting problem. The numbers of academic ethical violation were significantly higher than those with methodological flaw (z = 3.51; p < 0.01) or writing problem (z = 8.58; p < 0.001). The numbers of methodological flaw were also higher than that with writing problem (z = 6.47; p < 0.001). Moreover, an increased proportion of methodological flaw was observed since 2006, and the retraction year was significantly associated with increased proportion of methodological flaw when academic ethical violation as the reference group.

BackgroundMental disorders are a leading cause of distress and disability worldwide. To meet patient demand, there is a need for increased access to high-quality, evidence-based mental health care. Telehealth has become well established in the treatment of illnesses, including mental health conditions. ObjectiveThis study aims to conduct a robust evidence synthesis to assess whether there is evidence of differences between telehealth and face-to-face care for the management of less common mental and physical health conditions requiring psychotherapy. MethodsIn this systematic review, we included randomized controlled trials comparing telehealth (telephone, video, or both) versus the face-to-face delivery of psychotherapy for less common mental health conditions and physical health conditions requiring psychotherapy. The psychotherapy delivered had to be comparable between the telehealth and face-to-face groups, and it had to be delivered by general practitioners, primary care nurses, or allied health staff (such as psychologists and counselors). Patient (symptom severity, overall improvement in psychological symptoms, and function), process (working alliance and client satisfaction), and financial (cost) outcomes were included. ResultsA total of 12 randomized controlled trials were included, with 931 patients in aggregate; therapies included cognitive behavioral and family therapies delivered in populations encompassing addiction disorders, eating disorders, childhood mental health problems, and chronic conditions. Telehealth was delivered by video in 7 trials, by telephone in 3 trials, and by both in 1 trial, and the delivery mode was unclear in 1 trial. The risk of bias for the 12 trials was low or unclear for most domains, except for the lack of the blinding of participants, owing to the nature of the comparison. There were no significant differences in symptom severity between telehealth and face-to-face therapy immediately after treatment (standardized mean difference [SMD] 0.05, 95% CI −0.17 to 0.27) or at any other follow-up time point. Similarly, there were no significant differences immediately after treatment between telehealth and face-to-face care delivery on any of the other outcomes meta-analyzed, including overall improvement (SMD 0.00, 95% CI −0.40 to 0.39), function (SMD 0.13, 95% CI −0.16 to 0.42), working alliance client (SMD 0.11, 95% CI −0.34 to 0.57), working alliance therapist (SMD −0.16, 95% CI −0.91 to 0.59), and client satisfaction (SMD 0.12, 95% CI −0.30 to 0.53), or at any other time point (3, 6, and 12 months). ConclusionsWith regard to effectively treating less common mental health conditions and physical conditions requiring psychological support, there is insufficient evidence of a difference between psychotherapy delivered via telehealth and the same therapy delivered face-to-face. However, there was no includable evidence in this review for some serious mental health conditions, such as schizophrenia and bipolar disorders, and further high-quality research is needed to determine whether telehealth is a viable, equivalent treatment option for these conditions.

Abstract Background There is no international diagnostic agreement for gestational diabetes mellitus (GDM). In 2014, Australia adopted a new definition and testing procedure. Since then, significantly more women have been diagnosed with GDM but with little difference in health outcomes. We explored the priorities and preferences of women potentially impacted by a GDM diagnosis. Method We recruited 15 women from the Gold Coast, Australia, to participate in a pilot community jury (CJ). Over two days, the women deliberated on the following: (a) which important consequences of a diagnosis of GDM should be considered when defining GDM?; (b) what should Australian health practitioners call the condition known as GDM? Results Eight women attended the pilot CJ, and their recommendations were a consensus. Women were surprised that the level of risk for physical harms was low but emotional harms were high. The final ranking of important consequences (high to low) was as follows: women's negative emotions; management burden of GDM; overmedicalized pregnancy; minimizing infant risks; improving lifestyle; and macrosomia. To describe the four different clinical states of GDM, the women chose three different labels. One was GDM. Conclusions The women from this pilot CJ prioritized the consequences of a diagnosis of GDM differently from clinicians. The current glucose threshold for GDM in Australia is set at a cut‐point for adverse risks including macrosomia and neonatal hyperinsulinaemia. Definitions and guideline panels often fail to ask the affected public about their values and preferences. Community voices impacted by health policies should be embedded in the decision‐making process.

Abstract Background Healthcare represents a paradox. While change is everywhere, performance has flatlined: 60% of care on average is in line with evidence- or consensus-based guidelines, 30% is some form of waste or of low value, and 10% is harm. The 60-30-10 Challenge has persisted for three decades. Main body Current top-down or chain-logic strategies to address this problem, based essentially on linear models of change and relying on policies, hierarchies, and standardisation, have proven insufficient. Instead, we need to marry ideas drawn from complexity science and continuous improvement with proposals for creating a deep learning health system. This dynamic learning model has the potential to assemble relevant information including patients’ histories, and clinical, patient, laboratory, and cost data for improved decision-making in real time, or close to real time. If we get it right, the learning health system will contribute to care being more evidence-based and less wasteful and harmful. It will need a purpose-designed digital backbone and infrastructure, apply artificial intelligence to support diagnosis and treatment options, harness genomic and other new data types, and create informed discussions of options between patients, families, and clinicians. While there will be many variants of the model, learning health systems will need to spread, and be encouraged to do so, principally through diffusion of innovation models and local adaptations. Conclusion Deep learning systems can enable us to better exploit expanding health datasets including traditional and newer forms of big and smaller-scale data, e.g. genomics and cost information, and incorporate patient preferences into decision-making. As we envisage it, a deep learning system will support healthcare’s desire to continually improve, and make gains on the 60-30-10 dimensions. All modern health systems are awash with data, but it is only recently that we have been able to bring this together, operationalised, and turned into useful information by which to make more intelligent, timely decisions than in the past.

Abstract The fourth meeting of the International Collaboration for Automation of Systematic Reviews (ICASR) was held 5–6 November 2019 in The Hague, the Netherlands. ICASR is an interdisciplinary group whose goal is to maximize the use of technology for conducting rapid, accurate, and efficient systematic reviews of scientific evidence. The group seeks to facilitate the development and acceptance of automated techniques for systematic reviews. In 2018, the major themes discussed were the transferability of automation tools (i.e., tools developed for other purposes that might be used by systematic reviewers), the automated recognition of study design in multiple disciplines and applications, and approaches for the evaluation of automation tools.

Abstract 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.

Abstract Background Disproportionate regulation of health and medical research contributes to research waste. Better understanding of exemptions of research from ethics review in different jurisdictions may help to guide modification of review processes and reduce research waste. Our aim was to identify examples of low-risk human health and medical research exempt from ethics reviews in Australia, the United Kingdom, the United States and the Netherlands. Methods We examined documents providing national guidance on research ethics in each country, including those authored by the National Health and Medical Research Council (Australia), National Health Service (United Kingdom), the Office for Human Research Protections (United States) and the Central Committee on Research Involving Humans (the Netherlands). Examples and types of research projects exempt from ethics reviews were identified, and similar examples and types were grouped together. Results Nine categories of research were exempt from ethics reviews across the four countries; these were existing data or specimen, questionnaire or survey, interview, post-marketing study, evaluation of public benefit or service programme, randomised controlled trials, research with staff in their professional role, audit and service evaluation, and other exemptions. Existing non-identifiable data and specimens were exempt in all countries. Four categories – evaluation of public benefit or service programme, randomised controlled trials, research with staff in their professional role, and audit and service evaluation – were exempted by one country each. The remaining categories were exempted by two or three countries. Conclusions Examples and types of research exempt from research ethics reviews varied considerably. Given the considerable costs and burdens on researchers and ethics committees, it would be worthwhile to develop and provide clearer guidance on exemptions, illustrated with examples, with transparent underpinning rationales.

Objectives: To develop a thematic framework for the range of consequences arising from a diagnostic label from an individual, family/caregiver, healthcare professional, and community perspective.Design: Systematic scoping review of qualitative studies.Search Strategy: We searched PubMed, Embase, PsycINFO, Cochrane, and CINAHL for primary studies and syntheses of primary studies that explore the consequences of labelling non-cancer diagnoses. Reference lists of included studies were screened, and forward citation searches undertaken.Study Selection: We included peer reviewed publications describing the perceived consequences for individuals labelled with a non-cancer diagnostic label from four perspectives: that of the individual, their family/caregiver, healthcare professional and/or community members. We excluded studies using hypothetical scenarios.Data Extraction and Synthesis: Data extraction used a three-staged process: one third was used to develop a preliminary framework, the next third for framework validation, and the final third coded if thematic saturation was not achieved. Author themes and supporting quotes were extracted, and analysed from the perspective of individual, family/caregiver, healthcare professional, or community member.Results: After deduplication, searches identified 7,379 unique articles. Following screening, 146 articles, consisting of 128 primary studies and 18 reviews, were included. The developed framework consisted of five overarching themes relevant to the four perspectives: psychosocial impact (e.g., positive/negative psychological impact, social- and self-identity, stigma), support (e.g., increased, decreased, relationship changes, professional interactions), future planning (e.g., action and uncertainty), behaviour (e.g., beneficial or detrimental modifications), and treatment expectations (e.g., positive/negative experiences). Perspectives of individuals were most frequently reported.Conclusions: This review developed and validated a framework of five domains of consequences following diagnostic labelling. Further research is required to test the external validity and acceptability of the framework for individuals and their family/caregiver, healthcare professionals, and community.

Background: Antibiotic overprescribing is a major concern that contributes to the problem of antibiotic resistance. Aim: To assess the effect on antibiotic prescribing in primary care of telehealth (TH) consultations compared with face-to-face (F2F). Design & setting: Systematic review and meta-analysis of adult or paediatric patients with a history of a community-acquired acute infection (respiratory, urinary, or skin and soft tissue). Studies were included that compared synchronous TH consultations (phone or video-based) to F2F consultations in primary care. Method: PubMed, Embase, Cochrane CENTRAL (inception–2021), clinical trial registries and citing–cited references of included studies were searched. Two review authors independently screened the studies and extracted the data. Results: Thirteen studies were identified. The one small randomised controlled trial (RCT) found a non-significant 25% relative increase in antibiotic prescribing in the TH group. The remaining 10 were observational studies but did not control well for confounding and, therefore, were at high risk of bias. When pooled by specific infections, there was no consistent pattern. The six studies of sinusitis — including one before–after study — showed significantly less prescribing for acute rhinosinusitis in TH consultations, whereas the two studies of acute otitis media showed a significant increase. Pharyngitis, conjunctivitis, and urinary tract infections showed non-significant higher prescribing in the TH group. Bronchitis showed no change in prescribing. Conclusion: The impact of TH on prescribing appears to vary between conditions, with more increases than reductions. There is insufficient evidence to draw strong conclusions, however, and higher quality research is urgently needed.

Introduction Clinically complex patients often require multiple medications. Polypharmacy is associated with inappropriate prescriptions, which may lead to negative outcomes. Few effective tools are available to help physicians optimise patient medication. This study assesses whether an electronic medication management support system (eMMa) reduces hospitalisation and mortality and improves prescription quality/safety in patients with polypharmacy.Methods and analysis Planned design: pragmatic, parallel cluster-randomised controlled trial; general practices as randomisation unit; patients as analysis unit. As practice recruitment was poor, we included additional data to our primary endpoint analysis for practices and quarters from October 2017 to March 2021. Since randomisation was performed in waves, final study design corresponds to a stepped-wedge design with open cohort and step-length of one quarter. Scope: general practices, Westphalia-Lippe (Germany), caring for BARMER health fund-covered patients. Population: patients (≥18 years) with polypharmacy (≥5 prescriptions). Sample size: initially, 32 patients from each of 539 practices were required for each study arm (17 200 patients/arm), but only 688 practices were randomised after 2 years of recruitment. Design change ensures that 80% power is nonetheless achieved. Intervention: complex intervention eMMa. Follow-up: at least five quarters/cluster (practice). recruitment: practices recruited/randomised at different times; after follow-up, control group practices may access eMMa. Outcomes: primary endpoint is all-cause mortality and hospitalisation; secondary endpoints are number of potentially inappropriate medications, cause-specific hospitalisation preceded by high-risk prescribing and medication underuse. Statistical analysis: primary and secondary outcomes are measured quarterly at patient level. A generalised linear mixed-effect model and repeated patient measurements are used to consider patient clusters within practices. Time and intervention group are considered fixed factors; variation between practices and patients is fitted as random effects. Intention-to-treat principle is used to analyse primary and key secondary endpoints.Ethics and dissemination Trial approved by Ethics Commission of North-Rhine Medical Association. Results will be disseminated through workshops, peer-reviewed publications, local and international conferences.Trial registration NCT03430336. ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT03430336).

Objective To explore factors that potentially impact external validation performance while developing and validating a prognostic model for hospital admissions (HAs) in complex older general practice patients.Study design and setting Using individual participant data from four cluster-randomised trials conducted in the Netherlands and Germany, we used logistic regression to develop a prognostic model to predict all-cause HAs within a 6-month follow-up period. A stratified intercept was used to account for heterogeneity in baseline risk between the studies. The model was validated both internally and by using internal-external cross-validation (IECV).Results Prior HAs, physical components of the health-related quality of life comorbidity index, and medication-related variables were used in the final model. While achieving moderate discriminatory performance, internal bootstrap validation revealed a pronounced risk of overfitting. The results of the IECV, in which calibration was highly variable even after accounting for between-study heterogeneity, agreed with this finding. Heterogeneity was equally reflected in differing baseline risk, predictor effects and absolute risk predictions.Conclusions Predictor effect heterogeneity and differing baseline risk can explain the limited external performance of HA prediction models. With such drivers known, model adjustments in external validation settings (eg, intercept recalibration, complete updating) can be applied more purposefully.Trial registration number PROSPERO id: CRD42018088129.

Background: Long-term monitoring is important in chronic condition management. Despite considerable costs of monitoring, there is no or poor evidence on how, what and when to monitor. The aim of this study was to improve understanding, methods, evidence base and practice of clinical monitoring in primary care, focusing on two areas: chronic kidney disease and chronic heart failure. Objectives: The research questions were as follows: does the choice of test affect better care while being affordable to the NHS? Can the number of tests used to manage individuals with early-stage kidney disease, and hence the costs, be reduced? Is it possible to monitor heart failure using a simple blood test? Can this be done using a rapid test in a general practitioner consultation? Would changes in the management of these conditions be acceptable to patients and carers? Design: Various study designs were employed, including cohort, feasibility study, Clinical Practice Research Datalink analysis, seven systematic reviews, two qualitative studies, one cost-effectiveness analysis and one cost recommendation. Setting: This study was set in UK primary care. Data sources: Data were collected from study participants and sourced from UK general practice and hospital electronic health records, and worldwide literature. Participants: The participants were NHS patients (Clinical Practice Research Datalink: 4.5 million patients), chronic kidney disease and chronic heart failure patients managed in primary care (including 750 participants in the cohort study) and primary care health professionals. Interventions: The interventions were monitoring with blood and urine tests (for chronic kidney disease) and monitoring with blood tests and weight measurement (for chronic heart failure). Main outcome measures: The main outcomes were the frequency, accuracy, utility, acceptability, costs and cost-effectiveness of monitoring. Results: Chronic kidney disease: serum creatinine testing has increased steadily since 1997, with most results being normal (83% in 2013). Increases in tests of creatinine and proteinuria correspond to their introduction as indicators in the Quality and Outcomes Framework. The Chronic Kidney Disease Epidemiology Collaboration equation had 2.7% greater accuracy (95% confidence interval 1.6% to 3.8%) than the Modification of Diet in Renal Disease equation for estimating glomerular filtration rate. Estimated annual transition rates to the next chronic kidney disease stage are ≈ 2% for people with normal urine albumin, 3–5% for people with microalbuminuria (3–30 mg/mmol) and 3–12% for people with macroalbuminuria (> 30 mg/mmol). Variability in estimated glomerular filtration rate-creatinine leads to misclassification of chronic kidney disease stage in 12–15% of tests in primary care. Glycaemic-control and lipid-modifying drugs are associated with a 6% (95% confidence interval 2% to 10%) and 4% (95% confidence interval 0% to 8%) improvement in renal function, respectively. Neither estimated glomerular filtration rate-creatinine nor estimated glomerular filtration rate-Cystatin C have utility in predicting rate of kidney function change. Patients viewed phrases such as ‘kidney damage’ or ‘kidney failure’ as frightening, and the term ‘chronic’ was misinterpreted as serious. Diagnosis of asymptomatic conditions (chronic kidney disease) was difficult to understand, and primary care professionals often did not use ‘chronic kidney disease’ when managing patients at early stages. General practitioners relied on Clinical Commissioning Group or Quality and Outcomes Framework alerts rather than National Institute for Health and Care Excellence guidance for information. Cost-effectiveness modelling did not demonstrate a tangible benefit of monitoring kidney function to guide preventative treatments, except for individuals with an estimated glomerular filtration rate of 60–90 ml/minute/1.73 m2, aged < 70 years and without cardiovascular disease, where monitoring every 3–4 years to guide cardiovascular prevention may be cost-effective. Chronic heart failure: natriuretic peptide-guided treatment could reduce all-cause mortality by 13% and heart failure admission by 20%. Implementing natriuretic peptide-guided treatment is likely to require predefined protocols, stringent natriuretic peptide targets, relative targets and being located in a specialist heart failure setting. Remote monitoring can reduce all-cause mortality and heart failure hospitalisation, and could improve quality of life. Diagnostic accuracy of point-of-care N-terminal prohormone of B-type natriuretic peptide (sensitivity, 0.99; specificity, 0.60) was better than point-of-care B-type natriuretic peptide (sensitivity, 0.95; specificity, 0.57). Within-person variation estimates for B-type natriuretic peptide and weight were as follows: coefficient of variation, 46% and coefficient of variation, 1.2%, respectively. Point-of-care N-terminal prohormone of B-type natriuretic peptide within-person variability over 12 months was 881 pg/ml (95% confidence interval 380 to 1382 pg/ml), whereas between-person variability was 1972 pg/ml (95% confidence interval 1525 to 2791 pg/ml). For individuals, monitoring provided reassurance; future changes, such as increased testing, would be acceptable. Point-of-care testing in general practice surgeries was perceived positively, reducing waiting time and anxiety. Community heart failure nurses had greater knowledge of National Institute for Health and Care Excellence guidance than general practitioners and practice nurses. Health-care professionals believed that the cost of natriuretic peptide tests in routine monitoring would outweigh potential benefits. The review of cost-effectiveness studies suggests that natriuretic peptide-guided treatment is cost-effective in specialist settings, but with no evidence for its value in primary care settings. Limitations: No randomised controlled trial evidence was generated. The pathways to the benefit of monitoring chronic kidney disease were unclear. Conclusions: It is difficult to ascribe quantifiable benefits to monitoring chronic kidney disease, because monitoring is unlikely to change treatment, especially in chronic kidney disease stages G3 and G4. New approaches to monitoring chronic heart failure, such as point-of-care natriuretic peptide tests in general practice, show promise if high within-test variability can be overcome. Future work: The following future work is recommended: improve general practitioner–patient communication of early-stage renal function decline, and identify strategies to reduce the variability of natriuretic peptide. Study registration: This study is registered as PROSPERO CRD42015017501, CRD42019134922 and CRD42016046902. Funding: This project was funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 9, No. 10. See the NIHR Journals Library website for further project information.

Objective: The decisions and processes that may compose a systematic search strategy have not been formally identified and categorized. This study aimed to (1) identify all decisions that could be made and processes that could be used in a systematic search strategy and (2) create a hierarchical framework of those decisions and processes. Methods: The literature was searched for documents or guides on conducting a literature search for a systematic review or other evidence synthesis. The decisions or processes for locating studies were extracted from eligible documents and categorized into a structured hierarchical framework. Feedback from experts was sought to revise the framework. The framework was revised iteratively and tested using recently published literature on systematic searching. Results: Guidance documents were identified from expert organizations and a search of the literature and Internet. Data were extracted from 74 eligible documents to form the initial framework. The framework was revised based on feedback from 9 search experts and further review and testing by the authors. The hierarchical framework consists of 119 decisions or processes sorted into 17 categories and arranged under 5 topics. These topics are “Skill of the searcher,” “Selecting information to identify,” “Searching the literature electronically,” “Other ways to identify studies,” and “Updating the systematic review.” Conclusions:The work identifies and classifies the decisions and processes used in systematic searching. Future work can now focus on assessing and prioritizing research on the best methods for successfully identifying all eligible studies for a systematic review.

Abstract Background Widening definitions of health conditions have the potential to affect millions of people and should only occur when there is strong evidence of benefit. In the last version of the Diagnostic and Statistical Manual of Mental Disorders (DSM), the DSM-5 Committee changed the Attention Deficit Hyperactivity Disorder (ADHD) age of onset criterion in two ways: raising the age of symptom onset and removing the requirement for symptoms to cause impairment. Given concerns about ADHD prevalence and treatment rates, we aimed to evaluate the evidence available to support these changes using a recently developed Checklist for Modifying Disease Definitions. Methods We identified and analysed research informing changes to the DSM-IV-TR ADHD age of onset criterion. We compared this evidence to the evidence recommended in the Checklist for Modifying Disease Definitions. Results The changes to the DSM-IV-TR age of onset criterion were based on a literature review (publicly available as a 2 page document with online table of included studies), which we appraised as at high risk of bias. Estimates of the change in ADHD prevalence resulting from change to the age of onset criterion were based on a single study that included only a small number of children with ADHD (n = 68) and only assessed the impact of change to the age component of the criterion. No evidence was used by, or available to the Committee regarding the impact on prevalence of removal of the requirement for impairment, or the effect of the criterion changes on diagnostic precision, the prognosis of, or the potential benefits or harms for individuals diagnosed by the new, but not old criterion. Conclusions The changes to the age of onset criterion were based on minimal research evidence that suffered from either high risk of bias or poor applicability. The minimal documentation available makes it difficult to judge the rigor of the process behind the criterion changes. Use of the Checklist for Modifying Disease Definitions would assist future proposed modifications of the DSM ADHD criteria, provide guidance on the studies needed to inform potential changes and would improve the transparency and documentation of the process.

Abstract Poor recruitment to, and retention in, clinical trials is a source of research waste that could be reduced by more informed choices about participation. Barriers to effective recruitment and retention can be wide-ranging but relevance of the questions being addressed by trials and the outcomes that they are assessing are key for potential participants. Decisions about trial participation should be informed by general and trial-specific information and by considering broader assessments of ‘informedness’ and how they impact on both recruitment and retention. We suggest that more informed decisions about trial participation should encourage personally appropriate decisions, increase recruitment and retention, and reduce research waste and increase its value.

Abstract Background Although many aspects of systematic reviews use computational tools, systematic reviewers have been reluctant to adopt machine learning tools. Discussion We discuss that the potential reason for the slow adoption of machine learning tools into systematic reviews is multifactorial. We focus on the current absence of trust in automation and set-up challenges as major barriers to adoption. It is important that reviews produced using automation tools are considered non-inferior or superior to current practice. However, this standard will likely not be sufficient to lead to widespread adoption. As with many technologies, it is important that reviewers see “others” in the review community using automation tools. Adoption will also be slow if the automation tools are not compatible with workflows and tasks currently used to produce reviews. Many automation tools being developed for systematic reviews mimic classification problems. Therefore, the evidence that these automation tools are non-inferior or superior can be presented using methods similar to diagnostic test evaluations, i.e., precision and recall compared to a human reviewer. However, the assessment of automation tools does present unique challenges for investigators and systematic reviewers, including the need to clarify which metrics are of interest to the systematic review community and the unique documentation challenges for reproducible software experiments. Conclusion We discuss adoption barriers with the goal of providing tool developers with guidance as to how to design and report such evaluations and for end users to assess their validity. Further, we discuss approaches to formatting and announcing publicly available datasets suitable for assessment of automation technologies and tools. Making these resources available will increase trust that tools are non-inferior or superior to current practice. Finally, we identify that, even with evidence that automation tools are non-inferior or superior to current practice, substantial set-up challenges remain for main stream integration of automation into the systematic review process.

Abstract Background Case‐finding for dementia is practised by general practitioners (GPs) in Australia but without an awareness of community preferences. We explored the values and preferences of informed community members around case‐finding for dementia in Australian general practice. Design, setting and participants A before and after, mixed‐methods study in Gold Coast, Australia, with ten community members aged 50‐70. Intervention A 2‐day citizen/community jury. Participants were informed by experts about dementia, the potential harms and benefits of case‐finding, and ethical considerations. Primary and secondary outcomes We asked participants, “Should the health system encourage GPs to practice ‘case‐finding’ of dementia in people older than 50?” Case‐finding was defined as a GP initiating testing for dementia when the patient is unaware of symptoms. We also assessed changes in participant comprehension/knowledge, attitudes towards dementia and participants’ own intentions to undergo case‐finding for dementia if it were suggested. Results Participants voted unanimously against case‐finding for dementia, citing a lack of effective treatments, potential for harm to patients and potential financial incentives. However, they recognized that case‐finding was currently practised by Australian GPs and recommended specific changes to the guidelines. Participants increased their comprehension/knowledge of dementia, their attitude towards case‐finding became less positive, and their intentions to be tested themselves decreased. Conclusion Once informed, community jury participants did not agree case‐finding for dementia should be conducted by GPs. Yet their personal intentions to accept case‐finding varied. If case‐finding for dementia is recommended in the guidelines, then shared decision making is essential.

Abstract Background Clinicians frequently have questions about patient care. However, for more than half of the generated questions, answers are never pursued, and if they are, often not answered satisfactorily. We aimed to characterise the clinical questions asked and answers provided by general practitioners (GP) through posts to a popular professional social media network. Methods In this cross-sectional study, we analysed clinical questions and answers posted between January 20th and February 10th 2018 on a popular GP-restricted (Australia, New Zealand) Facebook group. Each clinical question was categorised according to ‘background’ or ‘foreground’ question; type (e.g. treatment, diagnosis); and the clinical topic (e.g. cardiovascular). Each answer provided in response to included questions was categorised into: (i) short answer (e.g. agree/disagree); (ii) provided an explanation to justify the answer; and (iii) referred to a published relevant evidence resource. Results Of 1060 new posts during the study period, 204 (19%) included a clinical question. GPs most commonly asked about treatment (n = 87; 43%) and diagnosis (n = 59; 29%). Five major topics (23% skin, 10% psychology, 9% cardiovascular, 8% female genital, and 7% musculoskeletal) accounted for 118 (58%) questions. Each question received on average 10 (SD = 9) answers: 42% were short; 51% provided an explanation; and only 6% referred to relevant research evidence. Only 3 answers referred to systematic reviews. Conclusions In this sample of Australian and New Zealand GPs, who were members of a GP social media group, GPs asked clinical questions that can be organised into a limited number of question types and topics. This might help guide the development of GP learning programs.

Abstract The third meeting of the International Collaboration for Automation of Systematic Reviews (ICASR) was held 17–18 October 2017 in London, England. ICASR is an interdisciplinary group whose goal is to maximize the use of technology for conducting rapid, accurate, and efficient systematic reviews of scientific evidence. The group seeks to facilitate the development and widespread acceptance of automated techniques for systematic reviews. The meeting’s conclusion was that the most pressing needs at present are to develop approaches for validating currently available tools and to provide increased access to curated corpora that can be used for validation. To that end, ICASR’s short-term goals in 2018–2019 are to propose and publish protocols for key tasks in systematic reviews and to develop an approach for sharing curated corpora for validating the automation of the key tasks.

Abstract Background The James Lind Initiative (JLI) was a work programme inaugurated by Iain Chalmers and Patricia Atkinson to press for better research for better health care. It ran between 2003 and 2018, when Iain Chalmers retired. During the 15 years of its existence, the JLI developed three strands of work in collaboration with the authors of this paper, and with others. Work themes The first work strand involved developing a process for use by patients, carers and clinicians to identify shared priorities for research – the James Lind Alliance. The second strand was a series of articles, meetings, prizes and other developments to raise awareness of the massive amounts of avoidable waste in research, and of ways of reducing it. The third strand involved using a variety of approaches to promote better public and professional understanding of the importance of research in clinical practice and public health. JLI work on the first two themes has been addressed in previously published reports. This paper summarises JLI involvement during the 15 years of its existence in giving talks, convening workshops, writing books, and creating websites and databases to promote critical thinking about treatment claims. Conclusion During its 15-year life, the James Lind Initiative worked collaboratively with others to create free teaching and learning resources to help children and adults learn how to recognise untrustworthy claims about the effects of treatments. These resources have been translated in more than twenty languages, but much more could be done to support their uptake and wider use.

Background: The impact of school holidays on influenza rates has been sparsely documented in Australia. In 2019, the early winter influenza season coincided with mid-year school breaks, enabling us the unusual opportunity to examine how influenza incidence changed during school holiday closure dates. Methods: The weekly influenza data from five Australian state and one territory health departments for the period of week 19 (mid-May) to week 39 (early October) 2019 were compared to each state’s public-school holiday closure dates. We used segmented regression to model the weekly counts and a negative binomial distribution to account for overdispersion due to autocorrelation. The models’ goodness-of-fit was assessed by plots of observed versus expected counts, plots of residuals versus predicted values, and Pearson’s Chi-square test. The main exposure was the July two-week school holiday period, using a lag of one week. The effect is estimated as a percent change in incidence level, and in slope. Results: School holidays were associated with significant declines in influenza incidence in three states and one territory by between 41% and 65%. Two states did not show evidence of declines although one of those states had already passed its peak by the time of the school holidays. The models showed acceptable goodness-of-fit. The first decline during school holidays is seen in the school aged (5-19 years) population, with the declines in the adult and infant populations being smaller and following a week later. Conclusions: Given the significant and rapid reductions in incidence, these results have important public health implications. Closure or extension of holiday periods could be an emergency option for state governments.

Background: Autoinflation balloons are used to treat patients with otitis media with effusion (OME) to help avoid surgery. Aim: To compare the ability of party balloons with Otovent balloons to produce sufficient pressure for a Valsalva manoeuvre. Design & setting: Pressure 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. Method: Each 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. Results: Otovent 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. Conclusion: Otovent 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.

Objective To identify, appraise and synthesise studies evaluating the downsides of wearing face masks in any setting. We also discuss potential strategies to mitigate these downsides.Design Systematic review and meta-analysis.Data sources PubMed, Embase, CENTRAL and EuropePMC were searched (inception–18 May 2020), and clinical registries were searched via CENTRAL. We also did a forward–backward citation search of the included studies.Inclusion criteria We included randomised controlled trials and observational studies comparing face mask use to any active intervention or to control.Data extraction and analysis Two author pairs independently screened articles for inclusion, extracted data and assessed the quality of included studies. The primary outcomes were compliance, discomforts, harms and adverse events of wearing face masks.Results We screened 5471 articles, including 37 (40 references); 11 were meta-analysed. For mask wear adherence, 47% (95% CI 25% to 68%, p

Objective Public cooperation to practise preventive health behaviours is essential to manage the transmission of infectious diseases such as COVID-19. We aimed to investigate beliefs about COVID-19 diagnosis, transmission and prevention that have the potential to impact the uptake of recommended public health strategies.Design An online cross-sectional survey.Participants A national sample of 1500 Australian adults with representative quotas for age and gender provided by an online panel provider.Main outcome measure Proportion of participants with correct/incorrect knowledge of COVID-19 preventive behaviours and reasons for misconceptions.Results Of the 1802 potential participants contacted, 289 did not qualify, 13 declined and 1500 participated in the survey (response rate 83%). Most participants correctly identified ‘washing your hands regularly with soap and water’ (92%) and ‘staying at least 1.5 m away from others’ (90%) could help prevent COVID-19. Over 40% (incorrectly) considered wearing gloves outside of the home would prevent them from contracting COVID-19. Views about face masks were divided. Only 66% of participants correctly identified that ‘regular use of antibiotics’ would not prevent COVID-19.Most participants (90%) identified ‘fever, fatigue and cough’ as indicators of COVID-19. However, 42% of participants thought that being unable to ‘hold your breath for 10 s without coughing’ was an indicator of having the virus. The most frequently reported sources of COVID-19 information were commercial television channels (56%), the Australian Broadcasting Corporation (43%) and the Australian Government COVID-19 information app (31%).Conclusions Public messaging about hand hygiene and physical distancing to prevent transmission appears to have been effective. However, there are clear, identified barriers for many individuals that have the potential to impede uptake or maintenance of these behaviours in the long term. We need to develop public health messages that harness these barriers to improve future cooperation. Ensuring adherence to these interventions is critical.

BackgroundAccurate seroprevalence estimates of SARS-CoV-2 in different populations could clarify the extent to which current testing strategies are identifying all active infection, and hence the true magnitude and spread of the infection. Our primary objective was to identify valid seroprevalence studies of SARS-CoV-2 infection and compare their estimates with the reported, and imputed, COVID-19 case rates within the same population at the same time point.MethodsWe searched PubMed, Embase, the Cochrane COVID-19 trials, and Europe-PMC for published studies and pre-prints that reported anti-SARS-CoV-2 IgG, IgM and/or IgA antibodies for serosurveys of the general community from 1 Jan to 12 Aug 2020.ResultsOf the 2199 studies identified, 170 were assessed for full text and 17 studies representing 15 regions and 118,297 subjects were includable. The seroprevalence proportions in 8 studies ranged between 1%-10%, with 5 studies under 1%, and 4 over 10%-from the notably hard-hit regions of Gangelt, Germany; Northwest Iran; Buenos Aires, Argentina; and Stockholm, Sweden. For seropositive cases who were not previously identified as COVID-19 cases, the majority had prior COVID-like symptoms. The estimated seroprevalences ranged from 0.56-717 times greater than the number of reported cumulative cases-half of the studies reported greater than 10 times more SARS-CoV-2 infections than the cumulative number of cases.ConclusionsThe findings show SARS-CoV-2 seroprevalence is well below "herd immunity" in all countries studied. The estimated number of infections, however, were much greater than the number of reported cases and deaths in almost all locations. The majority of seropositive people reported prior COVID-like symptoms, suggesting that undertesting of symptomatic people may be causing a substantial under-ascertainment of SARS-CoV-2 infections.

Background Polypharmacy interventions are resource-intensive and should be targeted to those at risk of negative health outcomes. Our aim was to develop and internally validate prognostic models to predict health-related quality of life (HRQoL) and the combined outcome of falls, hospitalisation, institutionalisation and nursing care needs, in older patients with multimorbidity and polypharmacy in general practices.Methods Design: two independent data sets, one comprising health insurance claims data (n=592 456), the other data from the PRIoritising MUltimedication in Multimorbidity (PRIMUM) cluster randomised controlled trial (n=502). Population: ≥60 years, ≥5 drugs, ≥3 chronic diseases, excluding dementia. Outcomes: combined outcome of falls, hospitalisation, institutionalisation and nursing care needs (after 6, 9 and 24 months) (claims data); and HRQoL (after 6 and 9 months) (trial data). Predictor variables in both data sets: age, sex, morbidity-related variables (disease count), medication-related variables (European Union-Potentially Inappropriate Medication list (EU-PIM list)) and health service utilisation. Predictor variables exclusively in trial data: additional socio-demographics, morbidity-related variables (Cumulative Illness Rating Scale, depression), Medication Appropriateness Index (MAI), lifestyle, functional status and HRQoL (EuroQol EQ-5D-3L). Analysis: mixed regression models, combined with stepwise variable selection, 10-fold cross validation and sensitivity analyses.Results Most important predictors of EQ-5D-3L at 6 months in best model (Nagelkerke’s R² 0.507) were depressive symptoms (−2.73 (95% CI: −3.56 to −1.91)), MAI (−0.39 (95% CI: −0.7 to −0.08)), baseline EQ-5D-3L (0.55 (95% CI: 0.47 to 0.64)). Models based on claims data and those predicting long-term outcomes based on both data sets produced low R² values. In claims data-based model with highest explanatory power (R²=0.16), previous falls/fall-related injuries, previous hospitalisations, age, number of involved physicians and disease count were most important predictor variables.Conclusions Best trial data-based model predicted HRQoL after 6 months well and included parameters of well-being not found in claims. Performance of claims data-based models and models predicting long-term outcomes was relatively weak. For generalisability, future studies should refit models by considering parameters representing well-being and functional status.

Introduction When health conditions are labelled it is often to classify and communicate a set of symptoms. While diagnostic labelling can provide explanation for an individual’s symptoms, it can also impact how individuals and others view those symptoms. Despite existing research regarding the effects of labelling health conditions, a synthesis of these effects has not occurred. We will conduct a systematic scoping review to synthesise the reported consequences and impact of being given a label for a health condition from an individual, societal and health practitioner perspective and explore in what context labelling of health conditions is considered important.Methods and analysis The review will adhere to the Joanna Briggs Methodology for Scoping Reviews. Searches will be conducted in five electronic databases (PubMed, Embase, PsycINFO, Cochrane, CINAHL). Reference lists of included studies will be screened and forward and backward citation searching of included articles will be conducted. We will include reviews and original studies which describe the consequences for individuals labelled with a non-cancer health condition. We will exclude hypothetical research designs and studies focused on the consequences of labelling cancer conditions, intellectual disabilities and/or social attributes. We will conduct thematic analyses for qualitative data and descriptive or meta-analyses for quantitative data where appropriate.Ethics and dissemination Ethical approval is not required for a scoping review. Results will be disseminated via publication in a peer-reviewed journal, conference presentations and lay-person summaries on various online platforms. Findings from this systematic scoping review will identify gaps in current understanding of how, when, why and for whom a diagnostic label is important and inform future research.

Background: The impact of school holidays on influenza rates has been sparsely documented in Australia. In 2019, the early winter influenza season coincided with mid-year school breaks, enabling us the unusual opportunity to examine how influenza incidence changed during school holiday closure dates. Methods: The weekly influenza data from five Australian state and one territory health departments for the period of week 19 (mid-May) to week 39 (early October) 2019 were compared to each state’s public-school holiday closure dates. We used segmented regression to model the weekly counts and a negative binomial distribution to account for overdispersion due to autocorrelation. The models’ goodness-of-fit was assessed by plots of observed versus expected counts, plots of residuals versus predicted values, and Pearson’s Chi-square test. The main exposure was the July two-week school holiday period, using a lag of one week. The effect is estimated as a percent change in incidence level, and in slope. Results: School holidays were associated with significant declines in influenza incidence in three states and one territory by between 41% and 65%. Two states did not show evidence of declines although one of those states had already passed its peak by the time of the school holidays. The models showed acceptable goodness-of-fit. The first decline during school holidays is seen in the school aged (5-19 years) population, with the declines in the adult and infant populations being smaller and following a week later. Conclusions: Given the significant and rapid reductions in incidence, these results have important public health implications. Closure or extension of holiday periods could be an emergency option for state governments.

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.

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.

Abstract Background Despite the established interest in evidence-based practice (EBP) as a core competence for clinicians, evidence for how best to teach and evaluate EBP remains weak. We sought to systematically assess coverage of the five EBP steps, review the outcome domains measured, and assess the properties of the instruments used in studies evaluating EBP educational interventions. Methods We conducted a systematic review of controlled studies (i.e. studies with a separate control group) which had investigated the effect of EBP educational interventions. We used citation analysis technique and tracked the forward and backward citations of the index articles (i.e. the systematic reviews and primary studies included in an overview of the effect of EBP teaching) using Web of Science until May 2017. We extracted information on intervention content (grouped into the five EBP steps), and the outcome domains assessed. We also searched the literature for published reliability and validity data of the EBP instruments used. Results Of 1831 records identified, 302 full-text articles were screened, and 85 included. Of these, 46 (54%) studies were randomised trials, 51 (60%) included postgraduate level participants, and 63 (75%) taught medical professionals. EBP Step 3 (critical appraisal) was the most frequently taught step (63 studies; 74%). Only 10 (12%) of the studies taught content which addressed all five EBP steps. Of the 85 studies, 52 (61%) evaluated EBP skills, 39 (46%) knowledge, 35 (41%) attitudes, 19 (22%) behaviours, 15 (18%) self-efficacy, and 7 (8%) measured reactions to EBP teaching delivery. Of the 24 instruments used in the included studies, 6 were high-quality (achieved ≥3 types of established validity evidence) and these were used in 14 (29%) of the 52 studies that measured EBP skills; 14 (41%) of the 39 studies that measured EBP knowledge; and 8 (26%) of the 35 studies that measured EBP attitude. Conclusions Most EBP educational interventions which have been evaluated in controlled studies focus on teaching only some of the EBP steps (predominantly critically appraisal of evidence) and did not use high-quality instruments to measure outcomes. Educational packages and instruments which address all EBP steps are needed to improve EBP teaching.

Abstract Mobile health apps aimed towards patients are an emerging field of mHealth. Their potential for improving self-management of chronic conditions is significant. Here, we propose a concept of “prescribable” mHealth apps, defined as apps that are currently available, proven effective, and preferably stand-alone, i.e., that do not require dedicated central servers and continuous monitoring by medical professionals. Our objectives were to conduct an overview of systematic reviews to identify such apps, assess the evidence of their effectiveness, and to determine the gaps and limitations in mHealth app research. We searched four databases from 2008 onwards and the Journal of Medical Internet Research for systematic reviews of randomized controlled trials (RCTs) of stand-alone health apps. We identified 6 systematic reviews including 23 RCTs evaluating 22 available apps that mostly addressed diabetes, mental health and obesity. Most trials were pilots with small sample size and of short duration. Risk of bias of the included reviews and trials was high. Eleven of the 23 trials showed a meaningful effect on health or surrogate outcomes attributable to apps. In conclusion, we identified only a small number of currently available stand-alone apps that have been evaluated in RCTs. The overall low quality of the evidence of effectiveness greatly limits the prescribability of health apps. mHealth apps need to be evaluated by more robust RCTs that report between-group differences before becoming prescribable. Systematic reviews should incorporate sensitivity analysis of trials with high risk of bias to better summarize the evidence, and should adhere to the relevant reporting guideline.