Kidney trajectory charts improve GP management of patients with reduced kidney function: a randomised controlled vignette study.

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.

Consensus Statement for Protocols of Factorial Randomized Trials: Extension of the SPIRIT 2013 Statement.

Importance: Trial protocols outline a trial's objectives as well as the methods (design, conduct, and analysis) that will be used to meet those objectives, and transparent reporting of trial protocols ensures objectives are clear and facilitates appraisal regarding the suitability of study methods. Factorial trials, in which 2 or more interventions are assessed in the same set of participants, have unique methodological considerations. However, no extension of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 Statement, which provides guidance on reporting of trial protocols, for factorial trials is available. Objective: To develop a consensus-based extension to the SPIRIT 2013 Statement for factorial trials. Evidence Review: The SPIRIT extension for factorial trials was developed using the Enhancing the Quality and Transparency of Health Research (EQUATOR) methodological framework. First, a list of reporting recommendations was generated using a scoping review of methodological articles identified using a MEDLINE search (inception to May 2019), which was supplemented with relevant articles from the personal collections of the authors. Second, a 3-round Delphi survey (January to June 2022, completed by 104 panelists from 14 countries) was conducted to assess the importance of items and identify additional recommendations. Third, a hybrid consensus meeting was held, attended by 15 panelists to finalize selection and wording of the checklist. Findings: This SPIRIT extension for factorial trials modified 9 of the 33 items in the SPIRIT 2013 checklist. Key reporting recommendations were that the rationale for using a factorial design should be provided, including whether an interaction is hypothesized; the treatment groups that will form the main comparisons should be identified; and statistical methods for each main comparison should be provided, including how interactions will be assessed. Conclusions and Relevance: In this consensus statement, 9 factorial-specific items were provided that should be addressed in all protocols of factorial trials to increase the trial's utility and transparency.

Reporting of Factorial Randomized Trials: Extension of the CONSORT 2010 Statement.

Importance: Transparent reporting of randomized trials is essential to facilitate critical appraisal and interpretation of results. Factorial trials, in which 2 or more interventions are assessed in the same set of participants, have unique methodological considerations. However, reporting of factorial trials is suboptimal. Objective: To develop a consensus-based extension to the Consolidated Standards of Reporting Trials (CONSORT) 2010 Statement for factorial trials. Design: Using the Enhancing the Quality and Transparency of Health Research (EQUATOR) methodological framework, the CONSORT extension for factorial trials was developed by (1) generating a list of reporting recommendations for factorial trials using a scoping review of methodological articles identified using a MEDLINE search (from inception to May 2019) and supplemented with relevant articles from the personal collections of the authors; (2) a 3-round Delphi survey between January and June 2022 to identify additional items and assess the importance of each item, completed by 104 panelists from 14 countries; and (3) a hybrid consensus meeting attended by 15 panelists to finalize the selection and wording of items for the checklist. Findings: This CONSORT extension for factorial trials modifies 16 of the 37 items in the CONSORT 2010 checklist and adds 1 new item. The rationale for the importance of each item is provided. Key recommendations are (1) the reason for using a factorial design should be reported, including whether an interaction is hypothesized, (2) the treatment groups that form the main comparisons should be clearly identified, and (3) for each main comparison, the estimated interaction effect and its precision should be reported. Conclusions and Relevance: This extension of the CONSORT 2010 Statement provides guidance on the reporting of factorial randomized trials and should facilitate greater understanding of and transparency in their reporting.

Physical interventions to interrupt or reduce the spread of respiratory viruses.

BACKGROUND: Viral epidemics or pandemics of acute respiratory infections (ARIs) pose a global threat. Examples are influenza (H1N1) caused by the H1N1pdm09 virus in 2009, severe acute respiratory syndrome (SARS) in 2003, and coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 in 2019. Antiviral drugs and vaccines may be insufficient to prevent their spread. This is an update of a Cochrane Review last published in 2020. We include results from studies from the current COVID-19 pandemic. OBJECTIVES: To assess the effectiveness of physical interventions to interrupt or reduce the spread of acute respiratory viruses. SEARCH METHODS: We searched CENTRAL, PubMed, Embase, CINAHL, and two trials registers in October 2022, with backwards and forwards citation analysis on the new studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and cluster-RCTs investigating physical interventions (screening at entry ports, isolation, quarantine, physical distancing, personal protection, hand hygiene, face masks, glasses, and gargling) to prevent respiratory virus transmission.  DATA COLLECTION AND ANALYSIS: We used standard Cochrane methodological procedures. MAIN RESULTS: We included 11 new RCTs and cluster-RCTs (610,872 participants) in this update, bringing the total number of RCTs to 78. Six of the new trials were conducted during the COVID-19 pandemic; two from Mexico, and one each from Denmark, Bangladesh, England, and Norway. We identified four ongoing studies, of which one is completed, but unreported, evaluating masks concurrent with the COVID-19 pandemic. Many studies were conducted during non-epidemic influenza periods. Several were conducted during the 2009 H1N1 influenza pandemic, and others in epidemic influenza seasons up to 2016. Therefore, many studies were conducted in the context of lower respiratory viral circulation and transmission compared to COVID-19. The included studies were conducted in heterogeneous settings, ranging from suburban schools to hospital wards in high-income countries; crowded inner city settings in low-income countries; and an immigrant neighbourhood in a high-income country. Adherence with interventions was low in many studies. The risk of bias for the RCTs and cluster-RCTs was mostly high or unclear. Medical/surgical masks compared to no masks We included 12 trials (10 cluster-RCTs) comparing medical/surgical masks versus no masks to prevent the spread of viral respiratory illness (two trials with healthcare workers and 10 in the community). Wearing masks in the community probably makes little or no difference to the outcome of influenza-like illness (ILI)/COVID-19 like illness compared to not wearing masks (risk ratio (RR) 0.95, 95% confidence interval (CI) 0.84 to 1.09; 9 trials, 276,917 participants; moderate-certainty evidence. Wearing masks in the community probably makes little or no difference to the outcome of laboratory-confirmed influenza/SARS-CoV-2 compared to not wearing masks (RR 1.01, 95% CI 0.72 to 1.42; 6 trials, 13,919 participants; moderate-certainty evidence). Harms were rarely measured and poorly reported (very low-certainty evidence). N95/P2 respirators compared to medical/surgical masks We pooled trials comparing N95/P2 respirators with medical/surgical masks (four in healthcare settings and one in a household setting). We are very uncertain on the effects of N95/P2 respirators compared with medical/surgical masks on the outcome of clinical respiratory illness (RR 0.70, 95% CI 0.45 to 1.10; 3 trials, 7779 participants; very low-certainty evidence). N95/P2 respirators compared with medical/surgical masks may be effective for ILI (RR 0.82, 95% CI 0.66 to 1.03; 5 trials, 8407 participants; low-certainty evidence). Evidence is limited by imprecision and heterogeneity for these subjective outcomes. The use of a N95/P2 respirators compared to medical/surgical masks probably makes little or no difference for the objective and more precise outcome of laboratory-confirmed influenza infection (RR 1.10, 95% CI 0.90 to 1.34; 5 trials, 8407 participants; moderate-certainty evidence). Restricting pooling to healthcare workers made no difference to the overall findings. Harms were poorly measured and reported, but discomfort wearing medical/surgical masks or N95/P2 respirators was mentioned in several studies (very low-certainty evidence).  One previously reported ongoing RCT has now been published and observed that medical/surgical masks were non-inferior to N95 respirators in a large study of 1009 healthcare workers in four countries providing direct care to COVID-19 patients.  Hand hygiene compared to control Nineteen trials compared hand hygiene interventions with controls with sufficient data to include in meta-analyses. Settings included schools, childcare centres and homes. Comparing hand hygiene interventions with controls (i.e. no intervention), there was a 14% relative reduction in the number of people with ARIs in the hand hygiene group (RR 0.86, 95% CI 0.81 to 0.90; 9 trials, 52,105 participants; moderate-certainty evidence), suggesting a probable benefit. In absolute terms this benefit would result in a reduction from 380 events per 1000 people to 327 per 1000 people (95% CI 308 to 342). When considering the more strictly defined outcomes of ILI and laboratory-confirmed influenza, the estimates of effect for ILI (RR 0.94, 95% CI 0.81 to 1.09; 11 trials, 34,503 participants; low-certainty evidence), and laboratory-confirmed influenza (RR 0.91, 95% CI 0.63 to 1.30; 8 trials, 8332 participants; low-certainty evidence), suggest the intervention made little or no difference. We pooled 19 trials (71, 210 participants) for the composite outcome of ARI or ILI or influenza, with each study only contributing once and the most comprehensive outcome reported. Pooled data showed that hand hygiene may be beneficial with an 11% relative reduction of respiratory illness (RR 0.89, 95% CI 0.83 to 0.94; low-certainty evidence), but with high heterogeneity. In absolute terms this benefit would result in a reduction from 200 events per 1000 people to 178 per 1000 people (95% CI 166 to 188). Few trials measured and reported harms (very low-certainty evidence). We found no RCTs on gowns and gloves, face shields, or screening at entry ports. AUTHORS' CONCLUSIONS: The high risk of bias in the trials, variation in outcome measurement, and relatively low adherence with the interventions during the studies hampers drawing firm conclusions. There were additional RCTs during the pandemic related to physical interventions but a relative paucity given the importance of the question of masking and its relative effectiveness and the concomitant measures of mask adherence which would be highly relevant to the measurement of effectiveness, especially in the elderly and in young children. There is uncertainty about the effects of face masks. The low to moderate certainty of evidence means our confidence in the effect estimate is limited, and that the true effect may be different from the observed estimate of the effect. The pooled results of RCTs did not show a clear reduction in respiratory viral infection with the use of medical/surgical masks. There were no clear differences between the use of medical/surgical masks compared with N95/P2 respirators in healthcare workers when used in routine care to reduce respiratory viral infection. Hand hygiene is likely to modestly reduce the burden of respiratory illness, and although this effect was also present when ILI and laboratory-confirmed influenza were analysed separately, it was not found to be a significant difference for the latter two outcomes. Harms associated with physical interventions were under-investigated. There is a need for large, well-designed RCTs addressing the effectiveness of many of these interventions in multiple settings and populations, as well as the impact of adherence on effectiveness, especially in those most at risk of ARIs.

The femoral intercondylar notch is an accurate landmark for the resection depth of the distal femur in total knee arthroplasty.

INTRODUCTION: Conventionally, the depth of distal femoral resection in total knee arthroplasty is referenced from the most prominent distal femoral condyle. This surgical technique does not consider pathological alterations of articular surfaces or severity of knee deformity. It has been hypothesized that the femoral intercondylar notch is a clinically reliable and more accurate alternative landmark for the resection depth of the distal femur in primary total knee arthroplasty. METHODS: The resection depths of the distal femur at the medial and lateral femoral condyles and intercondylar notch were measured using computer navigation in 406 total knee arthroplasties. Variability between the bone resection depths was analyzed by standard deviation, 95% confidence interval and variance. Clinical follow-up of outcome to a minimum of 12 months was performed to further inform and validate the analysis. RESULTS: Mean resection depth of the medial condyle was 10.7 mm, of the lateral condyle 7.9 mm and of the femoral intercondylar notch 1.9 mm. The femoral intercondylar notch had the lowest variance in resection depth among the three landmarks assessed, with a variance of 1.7 mm2 compared to 2.8 mm2 for the medial femoral condyle and 5.1 mm2 for the lateral femoral condyle. The intercondylar notch reference had the lowest standard deviation and 95% confidence interval. The resection depth referencing the notch was not sensitive to the degree of flexion contracture pre-operatively, whereas the medial and lateral condyles were. For varus deformed knees, distal femoral resection depth at the notch averaged 2 mm, which corresponds to the femoral prosthesis thickness at the intercondylar region, while for valgus deformed knees, the resection was flush with the intercondylar notch. CONCLUSIONS: The femoral intercondylar notch is a clinically practical and reproducible landmark for appropriate and accurate resection depth of the distal femur in primary total knee arthroplasty. LEVEL OF EVIDENCE: Level III: Retrospective cohort study.

A Brief Shared Decision-Making Intervention for Acute Respiratory Infections on Antibiotic Dispensing Rates in Primary Care: A Cluster Randomized Trial.

PURPOSE: To determine whether acute respiratory infection (ARI) decision aids and a general practitioner (GP) training package reduces antibiotic dispensing rate and improves GPs' knowledge of antibiotic benefit-harm evidence. METHODS: A cluster randomized trial of 27 Australian general practices (13 intervention, 14 control) involving 122 GPs. Intervention group GPs were given brief decision aids for 3 ARIs (acute otitis media, acute sore throat, acute bronchitis) and video-delivered training. Primary outcome was dispensing rate of target antibiotic classes (routinely used for ARIs), extracted for 12 months before, and following, randomization. Secondary outcomes were GPs' knowledge of antibiotic benefit-harm evidence; prescribing influences; acceptability, usefulness, and self-reported resource use; and dispensing rate of all antibiotics. RESULTS: The baseline mean dispensing rate of ARI-related antibiotics was 3.5% (intervention GPs) and 3.2% (control GPs) of consultations. After 12 months, mean rates decreased (to 2.9% intervention; 2.6% control): an 18% relative reduction from baseline but similar in both groups (rate ratio 1.01; 95% CI, 0.89-1.15). Greater increases in knowledge were seen in the intervention group than control; a significant increase (average 3.6; 95% CI, 2.4-4.7, P <.001) in the number of correct responses to the 22 knowledge questions. There were no between-group differences for other secondary outcomes. The intervention was well received, perceived as useful, and reported as used by about two-thirds of intervention GPs. CONCLUSIONS: A brief shared decision-making intervention provided to GPs did not reduce antibiotic dispensing more than usual care, although GPs' knowledge of relevant benefit-harm evidence increased significantly.

Kidney trajectory charts to assist general practitioners in the assessment of patients with reduced kidney function: a randomised vignette study.

OBJECTIVE: To investigate the decisional impact of an age-based chart of kidney function decline to support general practitioners (GPs) to appropriately interpret estimated glomerular filtration rate (eGFR) and identify patients with a clinically relevant kidney problem. DESIGN AND SETTING: Randomised vignette study PARTICIPANTS: 372 Australian GPs from August 2018 to November 2018. INTERVENTION: GPs were given two patient case scenarios: (1) an older woman with reduced but stable renal function and (2) a younger Aboriginal man with declining kidney function still in the normal range. One group was given an age-based chart of kidney function to assist their assessment of the patient (initial chart group); the second group was asked to assess the patients without the chart, and then again using the chart (delayed chart group). MAIN OUTCOME MEASURES: GPs' assessment of the likelihood-on a Likert scale-that the patients had chronic kidney disease (CKD) according to the usual definition or a clinical problem with their kidneys. RESULTS: Prior to viewing the age-based chart GPs were evenly distributed as to whether they thought case 1-the older woman-had CKD or a clinically relevant kidney problem. GPs who had initial access to the chart were less likely to think that the older woman had CKD, and less likely to think she had a clinically relevant problem with her kidneys than GPs who had not viewed the chart. After subsequently viewing the chart, 14% of GPs in the delayed chart group changed their opinion, to indicate she was unlikely to have a clinically relevant problem with her kidneys.Prior to viewing the chart, the majority of GPs (66%) thought case 2-the younger man-did not have CKD, and were evenly distributed as to whether they thought he had a clinically relevant kidney problem. In contrast, GPs who had initial access to the chart were more likely to think he had CKD and the majority (72%) thought he had a clinically relevant kidney problem. After subsequently viewing the chart, 37% of GPs in the delayed chart group changed their opinion to indicate he likely had a clinically relevant problem with his kidneys. CONCLUSIONS: Use of the chart changed GPs interpretation of eGFR, with increased recognition of the younger male patient's clinically relevant kidney problem, and increased numbers classifying the older female patient's kidney function as normal for her age. This study has shown the potential of an age-based kidney function chart to reduce both overdiagnosis and underdiagnosis.

The effect of eye protection on SARS-CoV-2 transmission: a systematic review.

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.

The decisions and processes involved in a systematic search strategy: a hierarchical framework.

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.

Physical interventions to interrupt or reduce the spread of respiratory viruses.

BACKGROUND: Viral epidemics or pandemics of acute respiratory infections (ARIs) pose a global threat. Examples are influenza (H1N1) caused by the H1N1pdm09 virus in 2009, severe acute respiratory syndrome (SARS) in 2003, and coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 in 2019. Antiviral drugs and vaccines may be insufficient to prevent their spread. This is an update of a Cochrane Review published in 2007, 2009, 2010, and 2011. The evidence summarised in this review does not include results from studies from the current COVID-19 pandemic. OBJECTIVES: To assess the effectiveness of physical interventions to interrupt or reduce the spread of acute respiratory viruses. SEARCH METHODS: We searched CENTRAL, PubMed, Embase, CINAHL on 1 April 2020. We searched ClinicalTrials.gov, and the WHO ICTRP on 16 March 2020. We conducted a backwards and forwards citation analysis on the newly included studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and cluster-RCTs of trials investigating physical interventions (screening at entry ports, isolation, quarantine, physical distancing, personal protection, hand hygiene, face masks, and gargling) to prevent respiratory virus transmission. In previous versions of this review we also included observational studies. However, for this update, there were sufficient RCTs to address our study aims.   DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. We used GRADE to assess the certainty of the evidence. Three pairs of review authors independently extracted data using a standard template applied in previous versions of this review, but which was revised to reflect our focus on RCTs and cluster-RCTs for this update. We did not contact trialists for missing data due to the urgency in completing the review. We extracted data on adverse events (harms) associated with the interventions. MAIN RESULTS: We included 44 new RCTs and cluster-RCTs in this update, bringing the total number of randomised trials to 67. There were no included studies conducted during the COVID-19 pandemic. Six ongoing studies were identified, of which three evaluating masks are being conducted concurrent with the COVID pandemic, and one is completed. Many studies were conducted during non-epidemic influenza periods, but several studies were conducted during the global H1N1 influenza pandemic in 2009, and others in epidemic influenza seasons up to 2016. Thus, studies were conducted in the context of lower respiratory viral circulation and transmission compared to COVID-19. The included studies were conducted in heterogeneous settings, ranging from suburban schools to hospital wards in high-income countries; crowded inner city settings in low-income countries; and an immigrant neighbourhood in a high-income country. Compliance with interventions was low in many studies. The risk of bias for the RCTs and cluster-RCTs was mostly high or unclear. Medical/surgical masks compared to no masks We included nine trials (of which eight were cluster-RCTs) comparing medical/surgical masks versus no masks to prevent the spread of viral respiratory illness (two trials with healthcare workers and seven in the community). There is low certainty evidence from nine trials (3507 participants) that wearing a mask may make little or no difference to the outcome of influenza-like illness (ILI) compared to not wearing a mask (risk ratio (RR) 0.99, 95% confidence interval (CI) 0.82 to 1.18. There is moderate certainty evidence that wearing a mask probably makes little or no difference to the outcome of laboratory-confirmed influenza compared to not wearing a mask (RR 0.91, 95% CI 0.66 to 1.26; 6 trials; 3005 participants). Harms were rarely measured and poorly reported. Two studies during COVID-19 plan to recruit a total of 72,000 people. One evaluates medical/surgical masks (N = 6000) (published Annals of Internal Medicine, 18 Nov 2020), and one evaluates cloth masks (N = 66,000). N95/P2 respirators compared to medical/surgical masks We pooled trials comparing N95/P2 respirators with medical/surgical masks (four in healthcare settings and one in a household setting). There is uncertainty over the effects of N95/P2 respirators when compared with medical/surgical masks on the outcomes of clinical respiratory illness (RR 0.70, 95% CI 0.45 to 1.10; very low-certainty evidence; 3 trials; 7779 participants) and ILI (RR 0.82, 95% CI 0.66 to 1.03; low-certainty evidence; 5 trials; 8407 participants). The evidence is limited by imprecision and heterogeneity for these subjective outcomes. The use of a N95/P2 respirator compared to a medical/surgical mask probably makes little or no difference for the objective and more precise outcome of laboratory-confirmed influenza infection (RR 1.10, 95% CI 0.90 to 1.34; moderate-certainty evidence; 5 trials; 8407 participants). Restricting the pooling to healthcare workers made no difference to the overall findings. Harms were poorly measured and reported, but discomfort wearing medical/surgical masks or N95/P2 respirators was mentioned in several studies. One ongoing study recruiting 576 people compares N95/P2 respirators with medical surgical masks for healthcare workers during COVID-19. Hand hygiene compared to control Settings included schools, childcare centres, homes, and offices. In a comparison of hand hygiene interventions with control (no intervention), there was a 16% relative reduction in the number of people with ARIs in the hand hygiene group (RR 0.84, 95% CI 0.82 to 0.86; 7 trials; 44,129 participants; moderate-certainty evidence), suggesting a probable benefit. When considering the more strictly defined outcomes of ILI and laboratory-confirmed influenza, the estimates of effect for ILI (RR 0.98, 95% CI 0.85 to 1.13; 10 trials; 32,641 participants; low-certainty evidence) and laboratory-confirmed influenza (RR 0.91, 95% CI 0.63 to 1.30; 8 trials; 8332 participants; low-certainty evidence) suggest the intervention made little or no difference. We pooled all 16 trials (61,372 participants) for the composite outcome of ARI or ILI or influenza, with each study only contributing once and the most comprehensive outcome reported. The pooled data showed that hand hygiene may offer a benefit with an 11% relative reduction of respiratory illness (RR 0.89, 95% CI 0.84 to 0.95; low-certainty evidence), but with high heterogeneity. Few trials measured and reported harms. There are two ongoing studies of handwashing interventions in 395 children outside of COVID-19. We identified one RCT on quarantine/physical distancing. Company employees in Japan were asked to stay at home if household members had ILI symptoms. Overall fewer people in the intervention group contracted influenza compared with workers in the control group (2.75% versus 3.18%; hazard ratio 0.80, 95% CI 0.66 to 0.97). However, those who stayed at home with their infected family members were 2.17 times more likely to be infected. We found no RCTs on eye protection, gowns and gloves, or screening at entry ports. AUTHORS' CONCLUSIONS: The high risk of bias in the trials, variation in outcome measurement, and relatively low compliance with the interventions during the studies hamper drawing firm conclusions and generalising the findings to the current COVID-19 pandemic. There is uncertainty about the effects of face masks. The low-moderate certainty of the evidence means our confidence in the effect estimate is limited, and that the true effect may be different from the observed estimate of the effect. The pooled results of randomised trials did not show a clear reduction in respiratory viral infection with the use of medical/surgical masks during seasonal influenza. There were no clear differences between the use of medical/surgical masks compared with N95/P2 respirators in healthcare workers when used in routine care to reduce respiratory viral infection. Hand hygiene is likely to modestly reduce the burden of respiratory illness. Harms associated with physical interventions were under-investigated. There is a need for large, well-designed RCTs addressing the effectiveness of many of these interventions in multiple settings and populations, especially in those most at risk of ARIs.

A randomised on-line survey exploring how health condition labels affect behavioural intentions.

OBJECTIVES: We examined the effect of 'labels' versus 'descriptions' across four asymptomatic health conditions: pre-diabetes, pre-hypertension, mild hyperlipidaemia, and chronic kidney disease stage 3A, on participants' intentions to pursue further tests. There were four secondary objectives: 1) assessing confidence and satisfaction in their intention to test further; 2) revealing psychological drivers affecting intentions; 3) exploring whether intentions, confidence and satisfaction differ by label vs. description and health condition; and 4) producing a perceptual map of illnesses by label condition. METHODS: Practitioner validated health-related scenarios were used. Two variants of each condition were developed. Participants were recruited through Qualtrics from Australia, Ireland and Canada and randomly assigned two 'labelled' or two 'descriptive' scenarios. RESULTS: There was no significant difference in intentions to test between label and description conditions (95% CI -0.76 to 0.33 points, p = 0.4). Confidence and satisfaction were both positively associated with intentions: regression coefficient (ß) for confidence ß = 0.58 points (95% CI 0.49 to 0.68, p < .001) and for satisfaction 0.67 points (95% CI 0.57 to 0.77, p < .001). Predisposition to seek healthcare (ß = 0.72; 95% CI 0.47 to 0.98), attributing illness to bad luck (ß = -0.16 points; 95% CI -0.3 to -0.02), and concern about the health condition (ß = 0.51; 95% CI 0.38 to 0.65) also significantly predicted intentions. CONCLUSIONS: Unlike studies investigating symptomatic illnesses, the disease label effect on behavioural intentions was not supported suggesting that reducing demand for medical services for borderline cases cannot be achieved by labelling. The average intention to test score was higher in this sample than previous symptomatic health-related studies and there was a positive relationship between increased intentions and confidence/satisfaction in one's decision. Exploratory insights suggested perceptions of the four labelled asymptomatic illnesses all shifted toward greater levels of dread and concern compared to their respective description condition. TRIAL REGISTRATION: ACTRN12618000392268.

Oral prednisolone for acute otitis media in children: a pilot, pragmatic, randomised, open-label, controlled study (OPAL study).

BACKGROUND: Acute otitis media (AOM) is associated with high antibiotic prescribing rates. Antibiotics are somewhat effective in improving pain and middle ear effusion (MEE); however, they have unfavourable effects. Alternative treatments, such as corticosteroids as anti-inflammatory agents, are needed. Evidence for the efficacy of these remains inconclusive. We conducted a pilot study to test feasibility of a proposed large-scale randomised controlled trial (RCT) to assess the efficacy of corticosteroids for AOM. METHODS: We conducted a pilot, pragmatic, parallel, open-label RCT of oral corticosteroids for paediatric AOM in primary and secondary/tertiary care centres in Indonesia. Children aged 6 months-12 years with AOM were randomised to either prednisolone or control (1:1). Physicians were blinded to allocation. Our objectives were to test the feasibility of our full RCT procedures and design, and assess the mechanistic effect of corticosteroids, using tympanometry, in suppressing middle ear inflammation by reducing MEE. RESULTS: We screened 512 children; 62 (38%) of 161 eligible children were randomised and 60 were analysed for the primary clinical outcome. All study procedures were completed successfully by healthcare personnel and parents/caregivers, despite time constraints and high workload. All eligible, consenting children were appropriately randomised. One child did not take the medication and four received additional oral corticosteroids. Our revised sample size calculation verified 444 children are needed for the full RCT. Oral corticosteroids did not have any discernible effects on MEE resolution and duration. There was no correlation between pain or other symptoms and MEE change. However, prednisolone may reduce pain intensity at day 3 (Visual Analogue Scale mean difference - 7.4 mm, 95% confidence interval (CI) - 13.4 to - 1.3, p = 0.018), but cause drowsiness (relative risk (RR) 1.8, 95% CI 1.1 to 2.8, p = 0.016). Tympanometry curves at day 7 may be improved (RR 1.8, 95% CI 1.0 to 2.9). We cannot yet confirm these as effects of corticosteroids due to insufficient sample size in this pilot study. CONCLUSIONS: It is feasible to conduct a large, pragmatic RCT of corticosteroids for paediatric AOM in Indonesia. Although oral corticosteroids may reduce pain and improve tympanometry curves, it requires an adequately powered clinical trial to confirm this. TRIAL REGISTRATION: Study registry number: ACTRN12618000049279. Name of registry: the Australian New Zealand Clinical Trials Registry (ANZCTR). Date of registration: 16 January 2018.

Barriers to and Facilitators of the Prescription of mHealth Apps in Australian General Practice: Qualitative Study.

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

mHealth App Prescription in Australian General Practice: Pre-Post Study.

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

Improving the translation of search strategies using the Polyglot Search Translator: a randomized controlled trial.

BACKGROUND: Searching for studies to include in a systematic review (SR) is a time- and labor-intensive process with searches of multiple databases recommended. To reduce the time spent translating search strings across databases, a tool called the Polyglot Search Translator (PST) was developed. The authors evaluated whether using the PST as a search translation aid reduces the time required to translate search strings without increasing errors. METHODS: In a randomized trial, twenty participants were randomly allocated ten database search strings and then randomly assigned to translate five with the assistance of the PST (PST-A method) and five without the assistance of the PST (manual method). We compared the time taken to translate search strings, the number of errors made, and how close the number of references retrieved by a translated search was to the number retrieved by a reference standard translation. RESULTS: Sixteen participants performed 174 translations using the PST-A method and 192 translations using the manual method. The mean time taken to translate a search string with the PST-A method was 31 minutes versus 45 minutes by the manual method (mean difference: 14 minutes). The mean number of errors made per translation by the PST-A method was 8.6 versus 14.6 by the manual method. Large variation in the number of references retrieved makes results for this outcome inconclusive, although the number of references retrieved by the PST-A method was closer to the reference standard translation than the manual method. CONCLUSION: When used to assist with translating search strings across databases, the PST can increase the speed of translation without increasing errors. Errors in search translations can still be a problem, and search specialists should be aware of this.

Efficacy of habit-based weight loss interventions: a systematic review and meta-analysis.

Habit-based interventions are a novel and emerging strategy to help reduce excess weight in individuals with overweight or obesity. This systematic review and meta-analysis aims to determine the efficacy of habit-based interventions on weight loss. We identified potential studies through electronic searches in February 2019. Included studies were randomized/quasi randomized controlled trials comparing weight loss interventions founded on habit-theory with a control (active or non-active) and enrolled adults with overweight or obesity (body mass index ≥ 25 kg/m2). Five trials (630 participants) met our inclusion criteria. After the intervention period (range 8-14 weeks), weight loss was modest but statistically different between groups (1.4 kg [95% confidence interval 0.5, 2.3; P = 0.004]) favoring habit-based interventions. Intervention groups averaged 2.5 kg weight loss (range 1.7 to 6.7 kg) compared with control 1.5 kg (range 0.4 to 5.8 kg) and were 2.4 times more likely to achieve clinically beneficial weight loss (≥ 5% weight reduction). Average weight losses in adults with overweight and obesity using habit-based interventions appear to be of clinical benefit. There were statistically significant differences in weight loss between habit-based interventions and controls, post-intervention. Longer studies powered to examine at least 12-month follow-up are required to more accurately determine the role of habit-based interventions on long-term weight loss maintenance.Trial registration Prospero ID: CRD42017065589. Available from https://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42017065589 .

Reporting of randomized factorial trials was frequently inadequate.

OBJECTIVES: Factorial designs can allow efficient evaluation of multiple treatments within a single trial. We evaluated the design, analysis, and reporting in a sample of factorial trials. STUDY DESIGN AND SETTING: Review of 2 × 2 factorial trials evaluating health-related interventions and outcomes in humans. Using Medline, we identified articles published between January 2015 and March 2018. We randomly selected 100 articles for inclusion. RESULTS: Most trials (78%) did not provide a rationale for using a factorial design. Only 63 trials (63%) assessed the interaction for the primary outcome, and 39/63 (62%) made a further assessment for at least one secondary outcome. 12/63 trials (19%) identified a significant interaction for the primary outcome and 16/39 trials (41%) for at least one secondary outcome. Inappropriate methods of analysis to protect against potential negative effects from interactions were common, with 18 trials (18%) choosing the analysis method based on a preliminary test for interaction, and 13% (n = 10/75) of those conducting a factorial analysis including an interaction term in the model. CONCLUSION: Reporting of factorial trials was often suboptimal, and assessment of interactions was poor. Investigators often used inappropriate methods of analysis to try to protect against adverse effects of interactions.

Current Knowledge and Adoption of Mobile Health Apps Among Australian General Practitioners: Survey Study.

BACKGROUND: Mobile health (mHealth) apps can be prescribed as an effective self-management tool for patients. However, it is challenging for doctors to navigate 350,000 mHealth apps to find the right ones to recommend. Although medical professionals from many countries are using mHealth apps to varying degrees, current mHealth app use by Australian general practitioners (GPs) and the barriers and facilitators they encounter when integrating mHealth apps in their clinical practice have not been reported comprehensively. OBJECTIVE: The objectives of this study were to (1) evaluate current knowledge and use of mHealth apps by GPs in Australia, (2) determine the barriers and facilitators to their use of mHealth apps in consultations, and (3) explore potential solutions to the barriers. METHODS: We helped the Royal Australian College of General Practitioners (RACGP) to expand the mHealth section of their annual technology survey for 2017 based on the findings of our semistructured interviews with GPs to further explore barriers to using mHealth apps in clinical practice. The survey was distributed to the RACGP members nationwide between October 26 and December 3, 2017 using Qualtrics Web-based survey tool. RESULTS: A total of 1014 RACGP members responded (response rate 4.6% [1014/21,884], completion rate 61.2% [621/1014]). The median years practiced was 20.7 years. Two-thirds of the GPs used apps professionally in the forms of medical calculators and point-of-care references. A little over half of the GPs recommended apps for patients either daily (12.9%, 80/621), weekly (25.9%, 161/621), or monthly (13.4%, 83/621). Mindfulness and mental health apps were recommended most often (32.5%, 337/1036), followed by diet and nutrition (13.9%, 144/1036), exercise and fitness (12.7%, 132/1036), and women's health (10%, 104/1036) related apps. Knowledge and usage of evidence-based apps from the Handbook of Non-Drug Interventions were low. The prevailing barriers to app prescription were the lack of knowledge of effective apps (59.9%, 372/621) and the lack of trustworthy source to access them (15.5%, 96/621). GPs expressed their need for a list of safe and effective apps from a trustworthy source, such as the RACGP, to overcome these barriers. They reported a preference for online video training material or webinar to learn more about mHealth apps. CONCLUSIONS: Most GPs are using apps professionally but recommending apps to patients sparingly. The main barriers to app prescription were the lack of knowledge of effective apps and the lack of trustworthy source to access them. A curated compilation of effective mHealth apps or an app library specifically aimed at GPs and health professionals would help solve both barriers.

Usability and acceptability of four systematic review automation software packages: a mixed method design.

AIM: New software packages help to improve the efficiency of conducting a systematic review through automation of key steps in the systematic review. The aim of this study was to gather qualitative data on the usability and acceptability of four systematic review automation software packages (Covidence, SRA-Helper for EndNote, Rayyan and RobotAnalyst) for the citation screening step of a systematic review. METHODS: We recruited three volunteer systematic reviewers and asked them to use allocated software packages during citation screening. They then completed a 12-item online questionnaire which was tailored to capture data for the software packages used. FINDINGS: All four software packages were reported to be easy or very easy to learn and use. SRA-Helper for EndNote was most favoured by participants for screening citations and Covidence for resolving conflicts. Overall, participants reported that SRA-Helper for EndNote would be their software package of choice, primarily due to its efficiency. CONCLUSION: This study identified a number of considerations which systematic reviewers can use as a basis of their decision which software to use when performing the citation screening and dispute resolution steps of a systematic review.

Undisclosed financial ties between guideline writers and pharmaceutical companies: a cross-sectional study across 10 disease categories.

OBJECTIVES: To investigate the proportion of potentially relevant undisclosed financial ties between clinical practice guideline writers and pharmaceutical companies. DESIGN: Cross-sectional study of a stratified random sample of Australian guidelines and writers. SETTING: Guidelines available from Australia's National Health and Medical Research Council guideline database, 2012-2014, stratified across 10 health priority areas. POPULATION: 402 authors of 33 guidelines, including up to four from each area, dependent on availability: arthritis/musculoskeletal (3); asthma (4); cancer (4); cardiovascular (4); diabetes (4); injury (3); kidney/urogenital (4); mental health (4); neurological (1); obesity (1). For guideline writers with no disclosures, or who disclosed no ties, a search of disclosures in the medical literature in the 5 years prior to guideline publication identified potentially relevant ties, undisclosed in guidelines. Guidelines were included if they contained recommendations of medicines, and writers included if developing or writing guidelines. MAIN OUTCOME MEASURES: Proportions of guideline writers with potentially relevant undisclosed financial ties to pharmaceutical companies active in the therapeutic area; proportion of guidelines including at least one writer with a potentially relevant undisclosed tie. RESULTS: 344 of 402 writers (86%; 95% CI 82% to 89%) either had no published disclosures (228) or disclosed they had no ties (116). Of the 344 with no disclosed ties, 83 (24%; 95% CI 20% to 29%) had potentially relevant undisclosed ties. Of 33 guidelines, 23 (70%; 95% CI 51% to 84%) included at least one writer with a potentially relevant undisclosed tie. Writers of guidelines developed and funded by governments were less likely to have undisclosed financial ties (8.1%vs30.6%; risk ratio 0.26; 95% CI 0.13 to 0.53; p<0.001). CONCLUSIONS: Almost one in four guideline writers with no disclosed ties may have potentially relevant undisclosed ties to pharmaceutical companies. These data confirm the need for strategies to ensure greater transparency and more independence in relationships between guidelines and industry.