Publications by authors named "Britta Tendal"

39 Publications

Awareness, Value and Use of the Australian living guidelines for the clinical care of people with COVID-19: An Impact Evaluation.

J Clin Epidemiol 2021 Nov 28. Epub 2021 Nov 28.

School of Public Health and Preventive Medicine, Monash University, Melbourne, Australi. Electronic address:

Introduction: The Australian National COVID-19 Clinical Evidence Taskforce is developing living, evidence-based, national guidelines for treatment of people with COVID-19. These living guidelines are updated each week. We undertook an impact evaluation to understand the extent to which health professionals providing treatment to people with COVID 19 were aware of, valued and used the guidelines, and the factors that enabled or hampered this.

Methods: A mixed methods approach was used for the evaluation. Surveys were conducted to collect both quantitative and qualitative data and were supplemented with qualitative interviews. Australian healthcare practitioners potentially providing care to individuals with suspected or confirmed COVID-19 were invited to participate. Data were collected on guideline awareness, relevance, ease of use, trustworthiness, value, importance of updating, use, and strengths and opportunities for improvement.

Results: A total of 287 people completed the surveys and 10 interviews were conducted during November 2020. Awareness of the work of the Taskforce was high and the vast majority of respondents reported that the guidelines were very or extremely relevant, easy to use, trustworthy and valuable. More than 50% of respondents had used the guidelines to support their own clinical decision-making; and 30% were aware of other examples of the guidelines being used. Qualitative data revealed that amongst an overwhelming morass of evidence and opinions during the COVID-19 pandemic, the guidelines have been a reliable, united source of evidence-based advice; participants felt the guidelines built confidence and provided reassurance in clinical decision-making. Opportunities to improve awareness and accessibility to the guidelines were also explored.

Conclusions: As of June 2021, the guidelines have been published and updated more than 40 times, include more than 140 recommendations and are being used to inform clinical decisions. The findings of this impact evaluation will be used to improve processes and outputs of the Taskforce and guidelines project, and to inform future living guideline projects.
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http://dx.doi.org/10.1016/j.jclinepi.2021.11.035DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8627590PMC
November 2021

Clinical care of children and adolescents with COVID-19: recommendations from the National COVID-19 Clinical Evidence Taskforce.

Med J Aust 2021 Oct 24. Epub 2021 Oct 24.

Sydney Children's Hospital, Randwick, Sydney, NSW.

Introduction: The epidemiology and clinical manifestations of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection are different in children and adolescents compared with adults. Although coronavirus disease 2019 (COVID-19) appears to be less common in children, with milder disease overall, severe complications may occur, including paediatric inflammatory multisystem syndrome (PIMS-TS). Recognising the distinct needs of this population, the National COVID-19 Clinical Evidence Taskforce formed a Paediatric and Adolescent Care Panel to provide living guidelines for Australian clinicians to manage children and adolescents with COVID-19 and COVID-19 complications. Living guidelines mean that these evidence-based recommendations are updated in near real time to give reliable, contemporaneous advice to Australian clinicians providing paediatric care.

Main Recommendations: To date, the Taskforce has made 20 specific recommendations for children and adolescents, including definitions of disease severity, recommendations for therapy, respiratory support, and venous thromboembolism prophylaxis for COVID-19 and for the management of PIMS-TS.

Changes In Management As A Result Of The Guidelines: The Taskforce currently recommends corticosteroids as first line treatment for acute COVID-19 in children and adolescents who require oxygen. Tocilizumab could be considered, and remdesivir should not be administered routinely in this population. Non-invasive ventilation or high flow nasal cannulae should be considered in children and adolescents with hypoxaemia or respiratory distress unresponsive to low flow oxygen if appropriate infection control measures can be used. Children and adolescents with PIMS-TS should be managed by a multidisciplinary team. Intravenous immunoglobulin and corticosteroids, with concomitant aspirin and thromboprophylaxis, should be considered for the treatment of PIMS-TS. The latest updates and full recommendations are available at www.covid19evidence.net.au.
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http://dx.doi.org/10.5694/mja2.51305DOI Listing
October 2021

Efficacy and Safety of Polyunsaturated Fatty Acids Supplementation in the Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Children and Adolescents: A Systematic Review and Meta-Analysis of Clinical Trials.

Nutrients 2021 Apr 8;13(4). Epub 2021 Apr 8.

The Danish Health Authority, 2300 Copenhagen, Denmark.

Based on epidemiological and animal studies, the rationale for using polyunsaturated fatty acids (PUFAs) as a treatment for Attention Deficit Hyperactivity Disorder (ADHD) seems promising. Here, the objective was to systematically identify and critically assess the evidence from clinical trials. The primary outcome was ADHD core symptoms. The secondary outcomes were behavioral difficulties, quality of life, and side effects. We performed a systematic search in Medline, Embase, Cinahl, PsycInfo, and the Cochrane Library up to June 2020. The overall certainty of evidence was evaluated using Grades of Recommendation, Assessment, Development, and Evaluation (GRADE). We identified 31 relevant randomized controlled trials including 1755 patients. The results showed no effect on ADHD core symptoms rated by parents (k = 23; SMD: -0.17; 95% CI: -0.32, -0.02) or teachers (k = 10; SMD: -0.06; 95% CI: -0.31, 0.19). There was no effect on behavioral difficulties, rated by parents (k = 7; SMD: -0.02; 95% CI: -0.17, 0.14) or teachers (k = 5; SMD: -0.04; 95% CI: -0.35, 0.26). There was no effect on quality of life (SMD: 0.01; 95% CI: -0.29, 0.31). PUFA did not increase the occurrence of side effects. For now, there seems to be no benefit of PUFA in ADHD treatment; however, the certainty of evidence is questionable, and thus no conclusive guidance can be made. The protocol is registered in PROSPERO ID: CRD42020158453.
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http://dx.doi.org/10.3390/nu13041226DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8068201PMC
April 2021

Prophylaxis against covid-19: living systematic review and network meta-analysis.

BMJ 2021 04 26;373:n949. Epub 2021 Apr 26.

Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.

Objective: To determine and compare the effects of drug prophylaxis on SARS-CoV-2 infection and covid-19.

Design: Living systematic review and network meta-analysis.

Data Sources: World Health Organization covid-19 database, a comprehensive multilingual source of global covid-19 literature to 25 March 2021, and six additional Chinese databases to 20 February 2021.

Study Selection: Randomised trials of people at risk of covid-19 who were assigned to receive prophylaxis or no prophylaxis (standard care or placebo). Pairs of reviewers independently screened potentially eligible articles.

Methods: Random effects bayesian network meta-analysis was performed after duplicate data abstraction. Included studies were assessed for risk of bias using a modification of the Cochrane risk of bias 2.0 tool, and certainty of evidence was assessed using the grading of recommendations assessment, development, and evaluation (GRADE) approach.

Results: The first iteration of this living network meta-analysis includes nine randomised trials-six of hydroxychloroquine (n=6059 participants), one of ivermectin combined with iota-carrageenan (n=234), and two of ivermectin alone (n=540), all compared with standard care or placebo. Two trials (one of ramipril and one of bromhexine hydrochloride) did not meet the sample size requirements for network meta-analysis. Hydroxychloroquine has trivial to no effect on admission to hospital (risk difference 1 fewer per 1000 participants, 95% credible interval 3 fewer to 4 more; high certainty evidence) or mortality (1 fewer per 1000, 2 fewer to 3 more; high certainty). Hydroxychloroquine probably does not reduce the risk of laboratory confirmed SARS-CoV-2 infection (2 more per 1000, 18 fewer to 28 more; moderate certainty), probably increases adverse effects leading to drug discontinuation (19 more per 1000, 1 fewer to 70 more; moderate certainty), and may have trivial to no effect on suspected, probable, or laboratory confirmed SARS-CoV-2 infection (15 fewer per 1000, 64 fewer to 41 more; low certainty). Owing to serious risk of bias and very serious imprecision, and thus very low certainty of evidence, the effects of ivermectin combined with iota-carrageenan on laboratory confirmed covid-19 (52 fewer per 1000, 58 fewer to 37 fewer), ivermectin alone on laboratory confirmed infection (50 fewer per 1000, 59 fewer to 16 fewer) and suspected, probable, or laboratory confirmed infection (159 fewer per 1000, 165 fewer to 144 fewer) remain very uncertain.

Conclusions: Hydroxychloroquine prophylaxis has trivial to no effect on hospital admission and mortality, probably increases adverse effects, and probably does not reduce the risk of SARS-CoV-2 infection. Because of serious risk of bias and very serious imprecision, it is highly uncertain whether ivermectin combined with iota-carrageenan and ivermectin alone reduce the risk of SARS-CoV-2 infection.

Systematic Review Registration: This review was not registered. The protocol established a priori is included as a supplement.

Readers' Note: This article is a living systematic review that will be updated to reflect emerging evidence. Updates may occur for up to two years from the date of original publication.
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http://dx.doi.org/10.1136/bmj.n949DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8073806PMC
April 2021

Prophylactic anticoagulants for people hospitalised with COVID-19.

Cochrane Database Syst Rev 2020 10 2;10:CD013739. Epub 2020 Oct 2.

Department of Surgery, Division of Vascular and Endovascular Surgery, Universidade Federal de São Paulo, São Paulo, Brazil.

Background: Coronavirus disease 2019 (COVID-19) is a serious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The primary manifestation is respiratory insufficiency that can also be related to diffuse pulmonary microthrombosis in people with COVID-19. This disease also causes thromboembolic events, such as pulmonary embolism, deep venous thrombosis, arterial thrombosis, catheter thrombosis, and disseminated intravascular coagulopathy. Recent studies have indicated a worse prognosis for people with COVID-19 who developed thromboembolism. Anticoagulants are medications used in the prevention and treatment of venous or arterial thromboembolic events. Several drugs are used in the prophylaxis and treatment of thromboembolic events, such as heparinoids (heparins or pentasaccharides), vitamin K antagonists and direct anticoagulants. Besides their anticoagulant properties, heparinoids have an additional anti-inflammatory potential, that may affect the clinical evolution of people with COVID-19. Some practical guidelines address the use of anticoagulants for thromboprophylaxis in people with COVID-19, however, the benefit of anticoagulants for people with COVID-19 is still under debate.

Objectives: To assess the effects of prophylactic anticoagulants versus active comparator, placebo or no intervention, on mortality and the need for respiratory support in people hospitalised with COVID-19.

Search Methods: We searched CENTRAL, MEDLINE, Embase, LILACS and IBECS databases, the Cochrane COVID-19 Study Register and medRxiv preprint database from their inception to 20 June 2020. We also checked reference lists of any relevant systematic reviews identified and contacted specialists in the field for additional references to trials.

Selection Criteria: Randomised controlled trials (RCTs), quasi-RCTs, cluster-RCTs and cohort studies that compared prophylactic anticoagulants (heparin, vitamin K antagonists, direct anticoagulants, and pentasaccharides) versus active comparator, placebo or no intervention for the management of people hospitalised with COVID-19. We excluded studies without a comparator group. Primary outcomes were all-cause mortality and need for additional respiratory support. Secondary outcomes were mortality related to COVID-19, deep vein thrombosis (DVT), pulmonary embolism, major bleeding, adverse events, length of hospital stay and quality of life.

Data Collection And Analysis: We used standard Cochrane methodological procedures. We used ROBINS-I to assess risk of bias for non-randomised studies (NRS) and GRADE to assess the certainty of evidence. We reported results narratively.

Main Results: We identified no RCTs or quasi-RCTs that met the inclusion criteria. We included seven retrospective NRS (5929 participants), three of which were available as preprints. Studies were conducted in China, Italy, Spain and the USA. All of the studies included people hospitalised with COVID-19, in either intensive care units, hospital wards or emergency departments. The mean age of participants (reported in 6 studies) ranged from 59 to 72 years. Only three included studies reported the follow-up period, which varied from 8 to 35 days. The studies did not report on most of our outcomes of interest: need for additional respiratory support, mortality related to COVID-19, DVT, pulmonary embolism, adverse events, and quality of life. Anticoagulants (all types) versus no treatment (6 retrospective NRS, 5685 participants) One study reported a reduction in all-cause mortality (adjusted odds ratio (OR) 0.42, 95% confidence interval (CI) 0.26 to 0.66; 2075 participants). One study reported a reduction in mortality only in a subgroup of 395 people who required mechanical ventilation (hazard ratio (HR) 0.86, 95% CI 0.82 to 0.89). Three studies reported no differences in mortality (adjusted OR 1.64, 95% CI 0.92 to 2.92; 449 participants; unadjusted OR 1.66, 95% CI 0.76 to 3.64; 154 participants and adjusted risk ratio (RR) 1.15, 95% CI 0.29 to 2.57; 192 participants). One study reported zero events in both intervention groups (42 participants). The overall risk of bias for all-cause mortality was critical and the certainty of the evidence was very low. One NRS reported bleeding events in 3% of the intervention group and 1.9% of the control group (OR 1.62, 95% CI 0.96 to 2.71; 2773 participants; low-certainty evidence). Therapeutic-dose anticoagulants versus prophylactic-dose anticoagulants (1 retrospective NRS, 244 participants) The study reported a reduction in all-cause mortality (adjusted HR 0.21, 95% CI 0.10 to 0.46) and a lower absolute rate of death in the therapeutic group (34.2% versus 53%). The overall risk of bias for all-cause mortality was serious and the certainty of the evidence was low. The study also reported bleeding events in 31.7% of the intervention group and 20.5% of the control group (OR 1.8, 95% CI 0.96 to 3.37; low-certainty evidence). Ongoing studies We found 22 ongoing studies in hospital settings (20 RCTs, 14,730 participants; 2 NRS, 997 participants) in 10 different countries (Australia (1), Brazil (1), Canada (2), China (3), France (2), Germany (1), Italy (4), Switzerland (1), UK (1) and USA (6)). Twelve ongoing studies plan to report mortality and six plan to report additional respiratory support. Thirteen studies are expected to be completed in December 2020 (6959 participants), eight in July 2021 (8512 participants), and one in December 2021 (256 participants). Four of the studies plan to include 1000 participants or more.

Authors' Conclusions: There is currently insufficient evidence to determine the risks and benefits of prophylactic anticoagulants for people hospitalised with COVID-19. Since there are 22 ongoing studies that plan to evaluate more than 15,000 participants in this setting, we will add more robust evidence to this review in future updates.
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http://dx.doi.org/10.1002/14651858.CD013739DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8166900PMC
October 2020

Sodium-glucose cotransporter protein-2 (SGLT-2) inhibitors and glucagon-like peptide-1 (GLP-1) receptor agonists for type 2 diabetes: systematic review and network meta-analysis of randomised controlled trials.

BMJ 2021 01 13;372:m4573. Epub 2021 Jan 13.

School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.

Objective: To evaluate sodium-glucose cotransporter-2 (SGLT-2) inhibitors and glucagon-like peptide-1 (GLP-1) receptor agonists in patients with type 2 diabetes at varying cardiovascular and renal risk.

Design: Network meta-analysis.

Data Sources: Medline, Embase, and Cochrane CENTRAL up to 11 August 2020.

Eligibility Criteria For Selecting Studies: Randomised controlled trials comparing SGLT-2 inhibitors or GLP-1 receptor agonists with placebo, standard care, or other glucose lowering treatment in adults with type 2 diabetes with follow up of 24 weeks or longer. Studies were screened independently by two reviewers for eligibility, extracted data, and assessed risk of bias.

Main Outcome Measures: Frequentist random effects network meta-analysis was carried out and GRADE (grading of recommendations assessment, development, and evaluation) used to assess evidence certainty. Results included estimated absolute effects of treatment per 1000 patients treated for five years for patients at very low risk (no cardiovascular risk factors), low risk (three or more cardiovascular risk factors), moderate risk (cardiovascular disease), high risk (chronic kidney disease), and very high risk (cardiovascular disease and kidney disease). A guideline panel provided oversight of the systematic review.

Results: 764 trials including 421 346 patients proved eligible. All results refer to the addition of SGLT-2 inhibitors and GLP-1 receptor agonists to existing diabetes treatment. Both classes of drugs lowered all cause mortality, cardiovascular mortality, non-fatal myocardial infarction, and kidney failure (high certainty evidence). Notable differences were found between the two agents: SGLT-2 inhibitors reduced mortality and admission to hospital for heart failure more than GLP-1 receptor agonists, and GLP-1 receptor agonists reduced non-fatal stroke more than SGLT-2 inhibitors (which appeared to have no effect). SGLT-2 inhibitors caused genital infection (high certainty), whereas GLP-1 receptor agonists might cause severe gastrointestinal events (low certainty). Low certainty evidence suggested that SGLT-2 inhibitors and GLP-1 receptor agonists might lower body weight. Little or no evidence was found for the effect of SGLT-2 inhibitors or GLP-1 receptor agonists on limb amputation, blindness, eye disease, neuropathic pain, or health related quality of life. The absolute benefits of these drugs vary substantially across patients from low to very high risk of cardiovascular and renal outcomes (eg, SGLT-2 inhibitors resulted in 5 to 48 fewer deaths in 1000 patients over five years; see interactive decision support tool (https://magicevidence.org/match-it/200820dist/#!/) for all outcomes.

Conclusions: In patients with type 2 diabetes, SGLT-2 inhibitors and GLP-1 receptor agonists reduced cardiovascular and renal outcomes, with notable differences in benefits and harms. Absolute benefits are determined by individual risk profiles of patients, with clear implications for clinical practice, as reflected in the Rapid Recommendations directly informed by this systematic review.

Systematic Review Registration: PROSPERO CRD42019153180.
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http://dx.doi.org/10.1136/bmj.m4573DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7804890PMC
January 2021

Weekly updates of national living evidence-based guidelines: methods for the Australian living guidelines for care of people with COVID-19.

J Clin Epidemiol 2021 03 11;131:11-21. Epub 2020 Nov 11.

School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia. Electronic address:

Background And Objectives: The Australian National COVID-19 Clinical Evidence Taskforce is a consortium of 31 Australian health professional organisations developing living, evidence-based guidelines for care of people with COVID-19, which are updated weekly. This article describes the methods used to develop and maintain the guidelines.

Methods: The guidelines use the GRADE methods and are designed to meet Australian NHMRC standards. Each week, new evidence is reviewed, current recommendations are revised, and new recommendations made. These are published in MAGIC and disseminated through traditional and social media. Relevant new questions to be addressed are continually sought from stakeholders and practitioners. For prioritized questions, the evidence is actively monitored and updated. Evidence surveillance combines horizon scans and targeted searches. An evidence team appraises and synthesizes evidence and prepares evidence-to-decision frameworks to inform development of recommendations. A guidelines leadership group oversees the development of recommendations by multidisciplinary guidelines panels and is advised by a consumer panel.

Results: The Taskforce formed in March 2020, and the first recommendations were published 2 weeks later. The guidelines have been revised and republished on a weekly basis for 24 weeks, and as of October 2020, contain over 90 treatment recommendations, suggesting that living methods are feasible in this context.

Conclusions: The Australian guidelines for care of people with COVID-19 provide an example of the feasibility of living guidelines and an opportunity to test and improve living evidence methods.
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http://dx.doi.org/10.1016/j.jclinepi.2020.11.005DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7657075PMC
March 2021

Clinical care of pregnant and postpartum women with COVID-19: Living recommendations from the National COVID-19 Clinical Evidence Taskforce.

Aust N Z J Obstet Gynaecol 2020 12 29;60(6):840-851. Epub 2020 Oct 29.

Maternal, Child and Adolescent Health Program, Burnet Institute, Melbourne, Victoria, Australia.

To date, 18 living recommendations for the clinical care of pregnant and postpartum women with COVID-19 have been issued by the National COVID-19 Clinical Evidence Taskforce. This includes recommendations on mode of birth, delayed umbilical cord clamping, skin-to-skin contact, breastfeeding, rooming-in, antenatal corticosteroids, angiotensin-converting enzyme inhibitors, disease-modifying treatments (including dexamethasone, remdesivir and hydroxychloroquine), venous thromboembolism prophylaxis and advanced respiratory support interventions (prone positioning and extracorporeal membrane oxygenation). Through continuous evidence surveillance, these living recommendations are updated in near real-time to ensure clinicians in Australia have reliable, evidence-based guidelines for clinical decision-making. Please visit https://covid19evidence.net.au/ for the latest recommendation updates.
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http://dx.doi.org/10.1111/ajo.13270DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7820999PMC
December 2020

Drug treatments for covid-19: living systematic review and network meta-analysis.

BMJ 2020 07 30;370:m2980. Epub 2020 Jul 30.

Department of Health Research Methods, Evidence, and Impact, McMaster University, 1280 Main St W, Hamilton, ON L8S 4L8, Canada.

Objective: To compare the effects of treatments for coronavirus disease 2019 (covid-19).

Design: Living systematic review and network meta-analysis.

Data Sources: WHO covid-19 database, a comprehensive multilingual source of global covid-19 literature, up to 1 March 2021 and six additional Chinese databases up to 20 February 2021. Studies identified as of 12 February 2021 were included in the analysis.

Study Selection: Randomised clinical trials in which people with suspected, probable, or confirmed covid-19 were randomised to drug treatment or to standard care or placebo. Pairs of reviewers independently screened potentially eligible articles.

Methods: After duplicate data abstraction, a bayesian network meta-analysis was conducted. Risk of bias of the included studies was assessed using a modification of the Cochrane risk of bias 2.0 tool, and the certainty of the evidence using the grading of recommendations assessment, development, and evaluation (GRADE) approach. For each outcome, interventions were classified in groups from the most to the least beneficial or harmful following GRADE guidance.

Results: 196 trials enrolling 76 767 patients were included; 111 (56.6%) trials and 35 098 (45.72%) patients are new from the previous iteration; 113 (57.7%) trials evaluating treatments with at least 100 patients or 20 events met the threshold for inclusion in the analyses. Compared with standard care, corticosteroids probably reduce death (risk difference 20 fewer per 1000 patients, 95% credible interval 36 fewer to 3 fewer, moderate certainty), mechanical ventilation (25 fewer per 1000, 44 fewer to 1 fewer, moderate certainty), and increase the number of days free from mechanical ventilation (2.6 more, 0.3 more to 5.0 more, moderate certainty). Interleukin-6 inhibitors probably reduce mechanical ventilation (30 fewer per 1000, 46 fewer to 10 fewer, moderate certainty) and may reduce length of hospital stay (4.3 days fewer, 8.1 fewer to 0.5 fewer, low certainty), but whether or not they reduce mortality is uncertain (15 fewer per 1000, 30 fewer to 6 more, low certainty). Janus kinase inhibitors may reduce mortality (50 fewer per 1000, 84 fewer to no difference, low certainty), mechanical ventilation (46 fewer per 1000, 74 fewer to 5 fewer, low certainty), and duration of mechanical ventilation (3.8 days fewer, 7.5 fewer to 0.1 fewer, moderate certainty). The impact of remdesivir on mortality and most other outcomes is uncertain. The effects of ivermectin were rated as very low certainty for all critical outcomes, including mortality. In patients with non-severe disease, colchicine may reduce mortality (78 fewer per 1000, 110 fewer to 9 fewer, low certainty) and mechanical ventilation (57 fewer per 1000, 90 fewer to 3 more, low certainty). Azithromycin, hydroxychloroquine, lopinavir-ritonavir, and interferon-beta do not appear to reduce risk of death or have an effect on any other patient-important outcome. The certainty in effects for all other interventions was low or very low.

Conclusion: Corticosteroids and interleukin-6 inhibitors probably confer important benefits in patients with severe covid-19. Janus kinase inhibitors appear to have promising benefits, but certainty is low. Azithromycin, hydroxychloroquine, lopinavir-ritonavir, and interferon-beta do not appear to have any important benefits. Whether or not remdesivir, ivermectin, and other drugs confer any patient-important benefit remains uncertain.

Systematic Review Registration: This review was not registered. The protocol is publicly available in the supplementary material.

Readers' Note: This article is a living systematic review that will be updated to reflect emerging evidence. Updates may occur for up to two years from the date of original publication. This is the fourth version of the original article published on 30 July 2020 (BMJ 2020;370:m2980), and previous versions can be found as data supplements. When citing this paper please consider adding the version number and date of access for clarity.
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http://dx.doi.org/10.1136/bmj.m2980DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7390912PMC
July 2020

Breathing life into Australian diabetes clinical guidelines.

Med J Aust 2020 04 14;212(6):250-251.e1. Epub 2020 Feb 14.

Monash University, Melbourne, VIC.

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http://dx.doi.org/10.5694/mja2.50509DOI Listing
April 2020

Social skills training for attention deficit hyperactivity disorder (ADHD) in children aged 5 to 18 years.

Cochrane Database Syst Rev 2019 06 21;6:CD008223. Epub 2019 Jun 21.

Child and Adolescent Psychiatric Department, Region Zealand, Birkevaenget 3, Roskilde, Denmark, 4300.

Background: Attention deficit hyperactivity disorder (ADHD) in children is associated with hyperactivity and impulsivity, attention problems, and difficulties with social interactions. Pharmacological treatment may alleviate the symptoms of ADHD but this rarely solves difficulties with social interactions. Children with ADHD may benefit from interventions designed to improve their social skills. We examined the benefits and harms of social skills training on social skills, emotional competencies, general behaviour, ADHD symptoms, performance in school of children with ADHD, and adverse events.

Objectives: To assess the beneficial and harmful effects of social skills training in children and adolescents with ADHD.

Search Methods: In July 2018, we searched CENTRAL, MEDLINE, Embase, PsycINFO, 4 other databases and two trials registers.We also searched online conference abstracts, and contacted experts in the field for information about unpublished or ongoing randomised clinical trials. We did not limit our searches by language, year of publication, or type or status of publication, and we sought translation of the relevant sections of non-English language articles.

Selection Criteria: Randomised clinical trials investigating social skills training versus either no intervention or waiting-list control, with or without pharmacological treatment of both comparison groups of children and adolescents with ADHD.

Data Collection And Analysis: We conducted the review in accordance with the Cochrane Handbook for Systematic Reviews of Intervention. We performed the analyses using Review Manager 5 software and Trial Sequential Analysis. We assessed bias according to domains for systematic errors. We assessed the certainty of the evidence with the GRADE approach.

Main Results: We included 25 randomised clinical trials described in 45 reports. The trials included a total of 2690 participants aged between five and 17 years. In 17 trials, participants were also diagnosed with various comorbidities.The social skills interventions were described as: 1) social skills training, 2) cognitive behavioural therapy, 3) multimodal behavioural/psychosocial therapy, 4) child life and attention skills treatment, 5) life skills training, 6) the "challenging horizon programme", 7) verbal self-instruction, 8) meta-cognitive training, 9) behavioural therapy, 10) behavioural and social skills treatment, and 11) psychosocial treatment. The control interventions were no intervention or waiting list.The duration of the interventions ranged from five weeks to two years. We considered the content of the social skills interventions to be comparable and based on a cognitive-behavioural model. Most of the trials compared child social skills training or parent training combined with medication versus medication alone. Some of the experimental interventions also included teacher consultations.More than half of the trials were at high risk of bias for generation of the allocation sequence and allocation concealment. No trial reported on blinding of participants and personnel. Most of the trials did not report on differences between groups in medication for comorbid disorders. We used all eligible trials in the meta-analyses, but downgraded the certainty of the evidence to low or very low.We found no clinically relevant treatment effect of social skills interventions on the primary outcome measures: teacher-rated social skills at end of treatment (standardised mean difference (SMD) 0.11, 95% confidence interval (CI) 0.00 to 0.22; 11 trials, 1271 participants; I = 0%; P = 0.05); teacher-rated emotional competencies at end of treatment (SMD -0.02, 95% CI -0.72 to 0.68; two trials, 129 participants; I = 74%; P = 0.96); or on teacher-rated general behaviour (SMD -0.06 (negative value better), 95% CI -0.19 to 0.06; eight trials, 1002 participants; I = 0%; P = 0.33). The effect on the primary outcome, teacher-rated social skills at end of treatment, corresponds to a MD of 1.22 points on the social skills rating system (SSRS) scale (95% CI 0.09 to 2.36). The minimal clinical relevant difference (10%) on the SSRS is 10.0 points (range 0 to 102 points on SSRS).We found evidence in favour of social skills training on teacher-rated core ADHD symptoms at end of treatment for all eligible trials (SMD -0.26, 95% CI -0.47 to -0.05; 14 trials, 1379 participants; I= 69%; P = 0.02), but the finding is questionable due to lack of support from sensitivity analyses, high risk of bias, lack of clinical significance, high heterogeneity, and low certainty.The studies did not report any serious or non-serious adverse events.

Authors' Conclusions: The review suggests that there is little evidence to support or refute social skills training for children and adolescents with ADHD. We may need more trials that are at low risk of bias and a sufficient number of participants to determine the efficacy of social skills training versus no training for ADHD. The evidence base regarding adolescents is especially weak.
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http://dx.doi.org/10.1002/14651858.CD008223.pub3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6587063PMC
June 2019

Lower mortality after early supervised pulmonary rehabilitation following COPD-exacerbations: a systematic review and meta-analysis.

BMC Pulm Med 2018 Sep 15;18(1):154. Epub 2018 Sep 15.

The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, DK-2100, Copenhagen, Denmark.

Background: Pulmonary rehabilitation (PR), delivered as a supervised multidisciplinary program including exercise training, is one of the cornerstones in the chronic obstructive pulmonary disease (COPD) management. We performed a systematic review and meta-analysis to assess the effect on mortality of a supervised early PR program, initiated during or within 4 weeks after hospitalization with an acute exacerbation of COPD compared with usual post-exacerbation care or no PR program. Secondary outcomes were days in hospital, COPD related readmissions, health-related quality of life (HRQoL), exercise capacity (walking distance), activities of daily living (ADL), fall risk and drop-out rate.

Methods: We identified randomized trials through a systematic search using MEDLINE, EMBASE and Cocharne Library and other sources through October 2017. Risk of bias was assessed regarding randomization, allocation sequence concealment, blinding, incomplete outcome data, selective outcome reporting, and other biases using the Cochrane Risk of Bias tool.

Results: We included 13 randomized trials (801 participants). Our meta-analyses showed a clinically relevant reduction in mortality after early PR (4 trials, 319 patients; RR = 0.58 (95% CI: [0.35 to 0.98])) and at the longest follow-up (3 trials, 127 patients; RR = 0.55 (95% CI: [0.12 to 2.57])). Early PR reduced number of days in hospital by 4.27 days (1 trial, 180 patients; 95% CI: [- 6.85 to - 1.69]) and hospital readmissions (6 trials, 319 patients; RR = 0.47 (95% CI: [0.29 to 0.75])). Moreover, early PR improved HRQoL and walking distance, and did not affect drop-out rate. Several of the trials had unclear risk of bias in regard to the randomization and blinding, for some outcome there was also a lack of power.

Conclusion: Moderate quality of evidence showed reductions in mortality, number of days in hospital and number of readmissions after early PR in patients hospitalized with a COPD exacerbation. Long-term effects on mortality were not statistically significant, but improvements in HRQoL and exercise capacity appeared to be maintained for at least 12 months. Therefore, we recommend early supervised PR to patients with COPD-related exacerbations. PR should be initiated during hospital admission or within 4 weeks after hospital discharge.
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http://dx.doi.org/10.1186/s12890-018-0718-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6139159PMC
September 2018

Minimum clinically important differences in chronic pain vary considerably by baseline pain and methodological factors: systematic review of empirical studies.

J Clin Epidemiol 2018 09 21;101:87-106.e2. Epub 2018 May 21.

Center for Evidence-Based Medicine, University of Southern Denmark & Odense University Hospital, Sdr. Boulevard 29, Gate 50 (Videncenteret), 5000 Odense C, Denmark; Odense Patient Data Explorative Network (OPEN), Odense, Denmark.

Background: The minimum clinically important difference (MCID) is used to interpret the relevance of treatment effects, e.g., when developing clinical guidelines, evaluating trial results or planning sample sizes. There is currently no agreement on an appropriate MCID in chronic pain and little is known about which contextual factors cause variation.

Methods: This is a systematic review. We searched PubMed, EMBASE, and Cochrane Library. Eligible studies determined MCID for chronic pain based on a one-dimensional pain scale, a patient-reported transition scale of perceived improvement, and either a mean change analysis (mean difference in pain among minimally improved patients) or a threshold analysis (pain reduction associated with best sensitivity and specificity for identifying minimally improved patients). Main results were descriptively summarized due to considerable heterogeneity, which were quantified using meta-analyses and explored using subgroup analyses and metaregression.

Results: We included 66 studies (31.254 patients). Median absolute MCID was 23 mm on a 0-100 mm scale (interquartile range [IQR] 12-39) and median relative MCID was 34% (IQR 22-45) among studies using the mean change approach. In both cases, heterogeneity was very high: absolute MCID I = 99% and relative MCID I = 96%. High variation was also seen among studies using the threshold approach: median absolute MCID was 20 mm (IQR 15-30) and relative MCID was 32% (IQR 15-41). Absolute MCID was strongly associated with baseline pain, explaining approximately two-thirds of the variation, and to a lesser degree with the operational definition of minimum pain relief and clinical condition. A total of 15 clinical and methodological factors were assessed as possible causes for variation in MCID.

Conclusions: MCID for chronic pain relief vary considerably. Baseline pain is strongly associated with absolute, but not relative, measures. To a much lesser degree, MCID is also influenced by the operational definition of relevant pain relief and possibly by clinical condition. Explicit and conscientious reflections on the choice of an MCID are required when classifying effect sizes as clinically important or trivial.
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http://dx.doi.org/10.1016/j.jclinepi.2018.05.007DOI Listing
September 2018

Pain relief that matters to patients: systematic review of empirical studies assessing the minimum clinically important difference in acute pain.

BMC Med 2017 Feb 20;15(1):35. Epub 2017 Feb 20.

Centre for Evidence-Based Medicine, University of Southern Denmark & Odense University Hospital, Sdr. Boulevard 29, Gate 50 (Videncenteret), 5000, Odense C, Denmark.

Background: The minimum clinically important difference (MCID) is used to interpret the clinical relevance of results reported by trials and meta-analyses as well as to plan sample sizes in new studies. However, there is a lack of consensus about the size of MCID in acute pain, which is a core symptom affecting patients across many clinical conditions.

Methods: We identified and systematically reviewed empirical studies of MCID in acute pain. We searched PubMed, EMBASE and Cochrane Library, and included prospective studies determining MCID using a patient-reported anchor and a one-dimensional pain scale (e.g. 100 mm visual analogue scale). We summarised results and explored reasons for heterogeneity applying meta-regression, subgroup analyses and individual patient data meta-analyses.

Results: We included 37 studies (8479 patients). Thirty-five studies used a mean change approach, i.e. MCID was assessed as the mean difference in pain score among patients who reported a minimum degree of improvement, while seven studies used a threshold approach, i.e. MCID was assessed as the threshold in pain reduction associated with the best accuracy (sensitivity and specificity) for identifying improved patients. Meta-analyses found considerable heterogeneity between studies (absolute MCID: I = 93%, relative MCID: I = 75%) and results were therefore presented qualitatively, while analyses focused on exploring reasons for heterogeneity. The reported absolute MCID values ranged widely from 8 to 40 mm (standardised to a 100 mm scale) and the relative MCID values from 13% to 85%. From analyses of individual patient data (seven studies, 918 patients), we found baseline pain strongly associated with absolute, but not relative, MCID as patients with higher baseline pain needed larger pain reduction to perceive relief. Subgroup analyses showed that the definition of improved patients (one or several categories improvement or meaningful change) and the design of studies (single or multiple measurements) also influenced MCID values.

Conclusions: The MCID in acute pain varied greatly between studies and was influenced by baseline pain, definitions of improved patients and study design. MCID is context-specific and potentially misguiding if determined, applied or interpreted inappropriately. Explicit and conscientious reflections on the choice of a reference value are required when using MCID to classify research results as clinically important or trivial.
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http://dx.doi.org/10.1186/s12916-016-0775-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5317055PMC
February 2017

Nonnucleoside Reverse-transcriptase Inhibitor- vs Ritonavir-boosted Protease Inhibitor-based Regimens for Initial Treatment of HIV Infection: A Systematic Review and Metaanalysis of Randomized Trials.

Clin Infect Dis 2016 07 18;63(2):268-80. Epub 2016 Apr 18.

Centre for Health & Infectious Diseases Research, Department of Infectious Diseases, Rigshospitalet, University of Copenhagen.

Background: Previous studies suggest that nonnucleoside reverse-transcriptase inhibitors (NNRTIs) cause faster virologic suppression, while ritonavir-boosted protease inhibitors (PI/r) recover more CD4 cells. However, individual trials have not been powered to compare clinical outcomes.

Methods: We searched databases to identify randomized trials that compared NNRTI- vs PI/r-based initial therapy. A metaanalysis calculated risk ratios (RRs) or mean differences (MDs), as appropriate. Primary outcome was death or progression to AIDS. Secondary outcomes were death, progression to AIDS, and treatment discontinuation. We calculated RR of virologic suppression and MD for an increase in CD4 cells at week 48.

Results: We included 29 trials with 9047 participants. Death or progression to AIDS occurred in 226 participants in the NNRTI arm and in 221 in the PI/r arm (RR, 1.03; 95% confidence interval, .87-1.22; 12 trials; n = 3825), death in 205 participants in the NNRTI arm vs 198 in the PI/r arm (1.04; 0.86-1.25; 22 trials; n = 8311), and progression to AIDS in 140 participants in the NNRTI arm vs 144 in the PI/r arm (1.00; 0.80-1.25; 13 trials; n = 4740). Overall treatment discontinuation (1.12; 0.93-1.35; 24 trials; n = 8249) and from toxicity (1.21; 0.87-1.68; 21 trials; n = 6195) were comparable, but discontinuation due to virologic failure was more common with NNRTI (1.58; 0.91-2.74; 17 trials; n = 5371). At week 48, there was no difference between NNRTI and PI/r in virologic suppression (RR, 1.03; 0.98-1.09) or CD4(+) recovery (MD, -4.7 cells; -14.2 to 4.8).

Conclusions: We found no difference in clinical and viro-immunologic outcomes between NNRTI- and PI/r-based therapy.
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http://dx.doi.org/10.1093/cid/ciw236DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6276924PMC
July 2016

Safety of deferring review after uneventful cataract surgery until 2 weeks postoperatively.

J Cataract Refract Surg 2015 Dec;41(12):2755-64

From the Department of Ophthalmology (Kessel), Copenhagen University Hospital Glostrup, Glostrup, the Danish Health and Medicines Authorities (Kessel, Tendal) and the Nordic Cochrane Center (Tendal), Rigshospitalet, Copenhagen, the Skanderborg Eye Clinic (Andresen), Skanderborg, the Department of Ophthalmology (Erngaard), Næstved Hospital, Næstved, the Odense Eye Clinic (Flesner), Odense, and the Department of Ophthalmology (Hjortdal), Aarhus University Hospital NBG, Aarhus, Denmark.

Unlabelled: We conducted a systematic review and metaanalysis to provide evidence-based recommendations on the value of early postoperative review. We identified 3 randomized controlled trials (RCTs) that compared patients seen on the first postoperative day with those reviewed at 2 weeks; the 3 studies comprised 886 patients. The risk for postoperative complications was lower when review was deferred 2 weeks because of early transient pressure spikes. There was no difference in the number of unscheduled visits during the first 2 weeks postoperatively or the visual acuity at follow-up. No safety was gained by reviewing patients on the first postoperative day, and we recommend that routine early postoperative control can be omitted in nonglaucomatous patients after uneventful surgery if symptomatic patients are seen by an ophthalmologist as needed.

Financial Disclosure: No author has a financial or proprietary interest in any material or method mentioned.
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http://dx.doi.org/10.1016/j.jcrs.2015.11.010DOI Listing
December 2015

Toric Intraocular Lenses in the Correction of Astigmatism During Cataract Surgery: A Systematic Review and Meta-analysis.

Ophthalmology 2016 Feb 18;123(2):275-286. Epub 2015 Nov 18.

Department of Ophthalmology, Aarhus University Hospital NBG, Aarhus, Denmark.

Topic: We performed a systematic review and meta-analysis to evaluate the benefit and harms associated with implantation of toric intraocular lenses (IOLs) during cataract surgery. Outcomes were postoperative uncorrected distance visual acuity (UCDVA) and distance spectacle independence. Harms were evaluated as surgical complications and residual astigmatism.

Clinical Relevance: Postoperative astigmatism is an important cause of suboptimal UCDVA and need for distance spectacles. Toric IOLs may correct for preexisting corneal astigmatism at the time of surgery.

Methods: We performed a systematic literature search in the Embase, PubMed, and CENTRAL databases within the Cochrane Library. We included randomized clinical trials (RCTs) if they compared toric with non-toric IOL implantation (± relaxing incision) in patients with regular corneal astigmatism and age-related cataracts. We assessed the risk of bias using the Cochrane Risk of Bias tool. We assessed the quality of evidence across studies using the GRADE profiler software (available at: www.gradeworkinggroup.org).

Results: We included 13 RCTs with 707 eyes randomized to toric IOLs and 706 eyes randomized to non-toric IOLs; 225 eyes had a relaxing incision. We found high-quality evidence that UCDVA was better in the toric IOL group (logarithm of the minimum angle of resolution [logMAR] mean difference, -0.07; 95% confidence interval [CI], -0.10 to -0.04) and provided greater spectacle independence (risk ratio [RR], 0.51; 95% CI, 0.36-0.71) and moderate quality evidence that toric IOL implantation was not associated with an increased risk of complications (RR, 1.73; 95% CI, 0.60-5.04). Residual astigmatism was lower in the toric IOL group than in the non-toric IOL plus relaxing incision group (mean difference, 0.37 diopter [D]; 95% CI, -0.55 to -0.19).

Conclusions: We found that toric IOLs provided better UCDVA, greater spectacle independence, and lower amounts of residual astigmatism than non-toric IOLs even when relaxing incisions were used.
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http://dx.doi.org/10.1016/j.ophtha.2015.10.002DOI Listing
February 2016

Immediate Sequential Bilateral Cataract Surgery: A Systematic Review and Meta-Analysis.

J Ophthalmol 2015 17;2015:912481. Epub 2015 Aug 17.

Department of Ophthalmology, Aarhus University Hospital NBG, 8000 Aarhus, Denmark.

The aim of the present systematic review was to examine the benefits and harms associated with immediate sequential bilateral cataract surgery (ISBCS) with specific emphasis on the rate of complications, postoperative anisometropia, and subjective visual function in order to formulate evidence-based national Danish guidelines for cataract surgery. A systematic literature review in PubMed, Embase, and Cochrane central databases identified three randomized controlled trials that compared outcome in patients randomized to ISBCS or bilateral cataract surgery on two different dates. Meta-analyses were performed using the Cochrane Review Manager software. The quality of the evidence was assessed using the GRADE method (Grading of Recommendation, Assessment, Development, and Evaluation). We did not find any difference in the risk of complications or visual outcome in patients randomized to ISBCS or surgery on two different dates. The quality of evidence was rated as low to very low. None of the studies reported the prevalence of postoperative anisometropia. In conclusion, we cannot provide evidence-based recommendations on the use of ISBCS due to the lack of high quality evidence. Therefore, the decision to perform ISBCS should be taken after careful discussion between the surgeon and the patient.
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http://dx.doi.org/10.1155/2015/912481DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4553313PMC
September 2015

Indication for cataract surgery. Do we have evidence of who will benefit from surgery? A systematic review and meta-analysis.

Acta Ophthalmol 2016 Feb 3;94(1):10-20. Epub 2015 Jun 3.

Department of Ophthalmology, Aarhus University Hospital NBG, Aarhus, Denmark.

The need for cataract surgery is expected to rise dramatically in the future due to the increasing proportion of elderly citizens and increasing demands for optimum visual function. The aim of this study was to provide an evidence-based recommendation for the indication of cataract surgery based on which group of patients are most likely to benefit from surgery. A systematic literature search was performed in the MEDLINE, CINAHL, EMBASE and COCHRANE LIBRARY databases. Studies evaluating the outcome after cataract surgery according to preoperative visual acuity and visual complaints were included in a meta-analysis. We identified eight observational studies comparing outcome after cataract surgery in patients with poor (<20/40) and fair (>20/40) preoperative visual acuity. We could not find any studies that compared outcome after cataract surgery in patients with few or many preoperative visual complaints. A meta-analysis showed that the outcome of cataract surgery, evaluated as objective and subjective visual improvement, was independent on preoperative visual acuity. There is a lack of scientific evidence to guide the clinician in deciding which patients are most likely to benefit from surgery. To overcome this shortage of evidence, many systems have been developed internationally to prioritize patients on waiting lists for cataract surgery, but the Swedish NIKE (Nationell Indikationsmodell för Katarakt Ekstraktion) is the only system where an association to the preoperative scoring of a patient has been related to outcome of cataract surgery. We advise that clinicians are inspired by the NIKE system when they decide which patients to operate to ensure that surgery is only offered to patients who are expected to benefit from cataract surgery.
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http://dx.doi.org/10.1111/aos.12758DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4744664PMC
February 2016

Author reply: To PMID 24935281.

Ophthalmology 2015 Jun;122(6):e35-6

Department of Ophthalmology, Århus University Hospital, Århus, Denmark.

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http://dx.doi.org/10.1016/j.ophtha.2014.11.028DOI Listing
June 2015

Antibiotic prevention of postcataract endophthalmitis: a systematic review and meta-analysis.

Acta Ophthalmol 2015 Jun 16;93(4):303-17. Epub 2015 Mar 16.

Department of Ophthalmology, Aarhus University Hospital NBG, Aarhus, Denmark.

Endophthalmitis is one of the most feared complications after cataract surgery. The aim of this systematic review was to evaluate the effect of intracameral and topical antibiotics on the prevention of endophthalmitis after cataract surgery. A systematic literature review in the MEDLINE, CINAHL, Cochrane Library and EMBASE databases revealed one randomized trial and 17 observational studies concerning the prophylactic effect of intracameral antibiotic administration on the rate of endophthalmitis after cataract surgery. The effect of topical antibiotics on endophthalmitis rate was reported by one randomized trial and one observational study. The quality and design of the included studies were analysed using the Cochrane risk of bias tool. The quality of the evidence was evaluated using the GRADE approach. We found high-to-moderate quality evidence for a marked reduction in the risk of endophthalmitis with the use of intracameral antibiotic administration of cefazolin, cefuroxime and moxifloxacin, whereas no effect was found with the use of topical antibiotics or intracameral vancomycin. Endophthalmitis occurred on average in one of 2855 surgeries when intracameral antibiotics were used compared to one of 485 surgeries when intracameral antibiotics were not used. The relative risk (95% CI) of endophthalmitis was reduced to 0.12 (0.08; 0.18) when intracameral antibiotics were used. The difference was highly significant (p < 0.00001). Intracameral antibiotic therapy is the best choice for preventing endophthalmitis after cataract surgery. We did not find evidence to conclude that topical antibiotic therapy prevents endophthalmitis.
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http://dx.doi.org/10.1111/aos.12684DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6680152PMC
June 2015

Author reply: To PMID 24935281.

Ophthalmology 2015 Feb;122(2):e17

Department of Ophthalmology, Aarhus University Hospital NBG, Aarhus, Denmark.

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http://dx.doi.org/10.1016/j.ophtha.2014.08.004DOI Listing
February 2015

Cataract surgery and age-related macular degeneration. An evidence-based update.

Acta Ophthalmol 2015 Nov 20;93(7):593-600. Epub 2015 Jan 20.

Department of Ophthalmology, Aarhus University Hospital NBG, Aarhus, Denmark.

Purpose: Age-related macular degeneration (AMD) and cataract often coexist in patients and concerns that cataract surgery is associated with an increased risk of incidence or progression of existing AMD has been raised. This systematic review and meta-analysis is focused on presenting the evidence concerning progression of AMD in patients undergoing cataract surgery.

Methods: We performed a systematic literature search in the PubMed, Medline, Cochrane Library and CINAHL databases. Two randomized trials and two case-control trials were identified. Quality of the studies was assessed using the Cochrane risk of bias tool, data were extracted, and meta-analyses were performed. Quality of the available evidence was evaluated using the GRADE system.

Results: We found that visual acuity at 6-12 months follow-up was significantly better (6.5-7.5 letters) in eyes that had undergone cataract surgery than in unoperated eyes, but the included number of subjects was small, and hence, the quality of evidence was downgraded to moderate. We did not find an increased risk of progression to exudative AMD 6-12 months after cataract surgery [RR 3.21 (0.14-75.68)], but the included number of subjects was small, and thus, the quality of the evidence was moderate.

Conclusion: Cataract surgery increases visual acuity without an increased risk of progression to exudative AMD, but further research with longer follow-up is encouraged.
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http://dx.doi.org/10.1111/aos.12665DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6680180PMC
November 2015

On the evidence for intrapartum fetal monitoring with ECG-ST analysis.

Acta Obstet Gynecol Scand 2015 Jan 13;94(1):117-8. Epub 2014 Nov 13.

Department of Obstetrics and Gynecology, Medical College of Georgia, Georgia Regents University, Augusta, GA, USA.

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http://dx.doi.org/10.1111/aogs.12531DOI Listing
January 2015

Post-cataract prevention of inflammation and macular edema by steroid and nonsteroidal anti-inflammatory eye drops: a systematic review.

Ophthalmology 2014 Oct 14;121(10):1915-24. Epub 2014 Jun 14.

Department of Ophthalmology, Aarhus University Hospital NBG, Aarhus, Denmark.

Purpose: Favorable outcome after cataract surgery depends on proper control of the inflammatory response induced by cataract surgery. Pseudophakic cystoid macular edema is an important cause of visual decline after uncomplicated cataract surgery.

Design: We compared the efficacy of topical steroids with topical nonsteroidal anti-inflammatory drugs (NSAIDs) in controlling inflammation and preventing pseudophakic cystoid macular edema (PCME) after uncomplicated cataract surgery.

Participants: Patients undergoing uncomplicated surgery for age-related cataract.

Methods: We performed a systematic literature search in Medline, CINAHL, Cochrane, and EMBASE databases to identify randomized trials published from 1996 onward comparing topical steroids with topical NSAIDs in controlling inflammation and preventing PCME in patients undergoing phacoemulsification with posterior chamber intraocular lens implantation for age-related cataract.

Main Outcome Measures: Postoperative inflammation and pseudophakic cystoid macular edema.

Results: Fifteen randomized trials were identified. Postoperative inflammation was less in patients randomized to NSAIDs. The prevalence of PCME was significantly higher in the steroid group than in the NSAID group: 3.8% versus 25.3% of patients, risk ratio 5.35 (95% confidence interval, 2.94-9.76). There was no statistically significant difference in the number of adverse events in the 2 treatment groups.

Conclusions: We found low to moderate quality of evidence that topical NSAIDs are more effective in controlling postoperative inflammation after cataract surgery. We found high-quality evidence that topical NSAIDs are more effective than topical steroids in preventing PCME. The use of topical NSAIDs was not associated with an increased events. We recommend using topical NSAIDs to prevent inflammation and PCME after routine cataract surgery.
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http://dx.doi.org/10.1016/j.ophtha.2014.04.035DOI Listing
October 2014

Post-cataract prevention of inflammation and macular edema by steroid and nonsteroidal anti-inflammatory eye drops: a systematic review.

Ophthalmology 2014 Oct 14;121(10):1915-24. Epub 2014 Jun 14.

Department of Ophthalmology, Aarhus University Hospital NBG, Aarhus, Denmark.

Purpose: Favorable outcome after cataract surgery depends on proper control of the inflammatory response induced by cataract surgery. Pseudophakic cystoid macular edema is an important cause of visual decline after uncomplicated cataract surgery.

Design: We compared the efficacy of topical steroids with topical nonsteroidal anti-inflammatory drugs (NSAIDs) in controlling inflammation and preventing pseudophakic cystoid macular edema (PCME) after uncomplicated cataract surgery.

Participants: Patients undergoing uncomplicated surgery for age-related cataract.

Methods: We performed a systematic literature search in Medline, CINAHL, Cochrane, and EMBASE databases to identify randomized trials published from 1996 onward comparing topical steroids with topical NSAIDs in controlling inflammation and preventing PCME in patients undergoing phacoemulsification with posterior chamber intraocular lens implantation for age-related cataract.

Main Outcome Measures: Postoperative inflammation and pseudophakic cystoid macular edema.

Results: Fifteen randomized trials were identified. Postoperative inflammation was less in patients randomized to NSAIDs. The prevalence of PCME was significantly higher in the steroid group than in the NSAID group: 3.8% versus 25.3% of patients, risk ratio 5.35 (95% confidence interval, 2.94-9.76). There was no statistically significant difference in the number of adverse events in the 2 treatment groups.

Conclusions: We found low to moderate quality of evidence that topical NSAIDs are more effective in controlling postoperative inflammation after cataract surgery. We found high-quality evidence that topical NSAIDs are more effective than topical steroids in preventing PCME. The use of topical NSAIDs was not associated with an increased events. We recommend using topical NSAIDs to prevent inflammation and PCME after routine cataract surgery.
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http://dx.doi.org/10.1016/j.ophtha.2014.04.035DOI Listing
October 2014

Benefits and harms in clinical trials of duloxetine for treatment of major depressive disorder: comparison of clinical study reports, trial registries, and publications.

BMJ 2014 Jun 4;348:g3510. Epub 2014 Jun 4.

Nordic Cochrane Centre, Rigshospitalet Dept 7811, Copenhagen, Denmark.

Objective: To determine, using research on duloxetine for major depressive disorder as an example, if there are inconsistencies between protocols, clinical study reports, and main publicly available sources (journal articles and trial registries), and within clinical study reports themselves, with respect to benefits and major harms.

Design: Data on primary efficacy analysis and major harms extracted from each data source and compared.

Setting: Nine randomised placebo controlled trials of duloxetine (total 2878 patients) submitted to the European Medicines Agency (EMA) for marketing approval for major depressive disorder.

Data Sources: Clinical study reports, including protocols as appendices (total 13,729 pages), were obtained from the EMA in May 2011. Journal articles were identified through relevant literature databases and contacting the manufacturer, Eli Lilly. Clinicaltrials.gov and the manufacturer's online clinical trial registry were searched for trial results.

Results: Clinical study reports fully described the primary efficacy analysis and major harms (deaths (including suicides), suicide attempts, serious adverse events, and discontinuations because of adverse events). There were minor inconsistencies in the population in the primary efficacy analysis between the protocol and clinical study report and within the clinical study report for one trial. Furthermore, we found contradictory information within the reports for seven serious adverse events and eight adverse events that led to discontinuation but with no apparent bias. In each trial, a median of 406 (range 177-645) and 166 (100-241) treatment emergent adverse events (adverse events that emerged or worsened after study drug was started) in the randomised phase were not reported in journal articles and Lilly trial registry reports, respectively. We also found publication bias in relation to beneficial effects.

Conclusion: Clinical study reports contained extensive data on major harms that were unavailable in journal articles and in trial registry reports. There were inconsistencies between protocols and clinical study reports and within clinical study reports. Clinical study reports should be used as the data source for systematic reviews of drugs, but they should first be checked against protocols and within themselves for accuracy and consistency.
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http://dx.doi.org/10.1136/bmj.g3510DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4045316PMC
June 2014

A critical appraisal of the evidence for using cardiotocography plus ECG ST interval analysis for fetal surveillance in labor. Part I: the randomized controlled trials.

Acta Obstet Gynecol Scand 2014 Jun;93(6):556-68; discussion 568-9

Department of Obstetrics and Gynecology, Institution of Clinical Sciences, Skåne University Hospital, Lund University, Malmö, Sweden.

We reappraised the five randomized controlled trials that compared cardiotocography plus ECG ST interval analysis (CTG+ST) vs. cardiotocography. The numbers enrolled ranged from 5681 (Dutch randomized controlled trial) to 799 (French randomized controlled trial). The Swedish randomized controlled trial (n = 5049) was the only trial adequately powered to show a difference in metabolic acidosis, and the Plymouth randomized controlled trial (n = 2434) was only powered to show a difference in operative delivery for fetal distress. There were considerable differences in study design: the French randomized controlled trial used different inclusion criteria, and the Finnish randomized controlled trial (n = 1483) used a different metabolic acidosis definition. In the CTG+ST study arms, the larger Plymouth, Swedish and Dutch trials showed lower operative delivery and metabolic acidosis rates, whereas the smaller Finnish and French trials showed minor differences in operative delivery and higher metabolic acidosis rates. We conclude that the differences in outcomes are likely due to the considerable differences in study design and size. This will enhance heterogeneity effects in any subsequent meta-analysis.
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http://dx.doi.org/10.1111/aogs.12413DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4670694PMC
June 2014

A critical appraisal of the evidence for using cardiotocography plus ECG ST interval analysis for fetal surveillance in labor. Part II: the meta-analyses.

Acta Obstet Gynecol Scand 2014 Jun;93(6):571-86; discussion 587-8

Department of Obstetrics and Gynecology, Institution of Clinical Sciences, Skåne University Hospital, Lund University, Malmö, Sweden.

We appraised the methodology, execution and quality of the five published meta-analyses that are based on the five randomized controlled trials which compared cardiotocography (CTG)+ST analysis to cardiotocography. The meta-analyses contained errors, either created de novo in handling of original data or from a failure to recognize essential differences among the randomized controlled trials, particularly in their inclusion criteria and outcome parameters. No meta-analysis contained complete and relevant data from all five randomized controlled trials. We believe that one randomized controlled trial excluded in two of the meta-analyses should have been included, whereas one randomized controlled trial that was included in all meta-analyses, should have been excluded. After correction of the uncovered errors and exclusion of the randomized controlled trial that we deemed inappropriate, our new meta-analysis showed that CTG+ST monitoring significantly reduces the fetal scalp blood sampling usage (risk ratio 0.64; 95% confidence interval 0.47-0.88), total operative delivery rate (0.93; 0.88-0.99) and metabolic acidosis rate (0.61; 0.41-0.91).
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http://dx.doi.org/10.1111/aogs.12412DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4670718PMC
June 2014
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