ERS/ESTS/ESTRO/ESR/ESTI/EFOMP statement on management of incidental findings from low dose CT screening for lung cancer.

BACKGROUND: Screening for lung cancer with low radiation dose computed tomography has a strong evidence base, is being introduced in several European countries and is recommended as a new targeted cancer screening programme. The imperative now is to ensure that implementation follows an evidence-based process that will ensure clinical and cost effectiveness. This European Respiratory Society (ERS) task force was formed to provide an expert consensus for the management of incidental findings which can be adapted and followed during implementation. METHODS: A multi-European society collaborative group was convened. 23 topics were identified, primarily from an ERS statement on lung cancer screening, and a systematic review of the literature was conducted according to ERS standards. Initial review of abstracts was completed and full text was provided to members of the group for each topic. Sections were edited and the final document approved by all members and the ERS Science Council. RESULTS: Nine topics considered most important and frequent were reviewed as standalone topics (interstitial lung abnormalities, emphysema, bronchiectasis, consolidation, coronary calcification, aortic valve disease, mediastinal mass, mediastinal lymph nodes and thyroid abnormalities). Other topics considered of lower importance or infrequent were grouped into generic categories, suitable for general statements. CONCLUSIONS: This European collaborative group has produced an incidental findings statement that can be followed during lung cancer screening. It will ensure that an evidence-based approach is used for reporting and managing incidental findings, which will mean that harms are minimised and any programme is as cost-effective as possible.

ERS/ESTS/ESTRO/ESR/ESTI/EFOMP statement on management of incidental findings from low dose CT screening for lung cancer.

BACKGROUND: Screening for lung cancer with low radiation dose computed tomography has a strong evidence base, is being introduced in several European countries and is recommended as a new targeted cancer screening programme. The imperative now is to ensure that implementation follows an evidence-based process that will ensure clinical and cost effectiveness. This European Respiratory Society (ERS) task force was formed to provide an expert consensus for the management of incidental findings which can be adapted and followed during implementation. METHODS: A multi-European society collaborative group was convened. 23 topics were identified, primarily from an ERS statement on lung cancer screening, and a systematic review of the literature was conducted according to ERS standards. Initial review of abstracts was completed and full text was provided to members of the group for each topic. Sections were edited and the final document approved by all members and the ERS Science Council. RESULTS: Nine topics considered most important and frequent were reviewed as standalone topics (interstitial lung abnormalities, emphysema, bronchiectasis, consolidation, coronary calcification, aortic valve disease, mediastinal mass, mediastinal lymph nodes and thyroid abnormalities). Other topics considered of lower importance or infrequent were grouped into generic categories, suitable for general statements. CONCLUSIONS: This European collaborative group has produced an incidental findings statement that can be followed during lung cancer screening. It will ensure that an evidence-based approach is used for reporting and managing incidental findings, which will mean that harms are minimised and any programme is as cost-effective as possible.

Developing a Pan-European Technical Standard for a Comprehensive High-quality Lung Cancer CT Screening Program. An ERS Technical Standard.

Screening for lung cancer with low radiation dose computed tomography (LDCT) has a strong evidence base. The European Council adopted a recommendation in November 2022 that lung cancer screening be implemented using a stepwise approach. The imperative now is to ensure that implementation follows an evidence-based process that delivers clinical and cost effectiveness. This ERS Taskforce was formed to provide a technical standard for a high-quality lung cancer screening program. METHOD: A collaborative group was convened to include members of multiple European societies (see below). Topics were identified during a scoping review and a systematic review of the literature was conducted. Full text was provided to members of the group for each topic. The final document was approved by all members and the ERS Scientific Advisory Committee. RESULTS: Ten topics were identified representing key components of a screening program. The action on findings from the LDCT were not included as they are addressed by separate international guidelines (nodule management and clinical management of lung cancer) and by a linked taskforce (incidental findings). Other than smoking cessation, other interventions that are not part of the core screening process were not included (e.g. pulmonary function measurement). Fifty-three statements were produced and areas for further research identified. CONCLUSION: This European collaborative group has produced a technical standard that is a timely contribution to implementation of LCS. It will serve as a standard that can be used, as recommended by the European Council, to ensure a high quality and effective program.

ERS/ESICM/ESCMID/ALAT guidelines for the management of severe community-acquired pneumonia.

BACKGROUND: Severe community-acquired pneumonia (sCAP) is associated with high morbidity and mortality, and while European and non-European guidelines are available for community-acquired pneumonia, there are no specific guidelines for sCAP. MATERIALS AND METHODOLOGY: The European Respiratory Society (ERS), European Society of Intensive Care Medicine (ESICM), European Society of Clinical Microbiology and Infectious Diseases (ESCMID) and Latin American Thoracic Association (ALAT) launched a task force to develop the first international guidelines for sCAP. The panel comprised a total of 18 European and four non-European experts, as well as two methodologists. Eight clinical questions for sCAP diagnosis and treatment were chosen to be addressed. Systematic literature searches were performed in several databases. Meta-analyses were performed for evidence synthesis, whenever possible. The quality of evidence was assessed with GRADE (Grading of Recommendations, Assessment, Development and Evaluation). Evidence to Decision frameworks were used to decide on the direction and strength of recommendations. RESULTS: Recommendations issued were related to diagnosis, antibiotics, organ support, biomarkers and co-adjuvant therapy. After considering the confidence in effect estimates, the importance of outcomes studied, desirable and undesirable consequences of treatment, cost, feasibility, acceptability of the intervention and implications to health equity, recommendations were made for or against specific treatment interventions. CONCLUSIONS: In these international guidelines, ERS, ESICM, ESCMID and ALAT provide evidence-based clinical practice recommendations for diagnosis, empirical treatment and antibiotic therapy for sCAP, following the GRADE approach. Furthermore, current knowledge gaps have been highlighted and recommendations for future research have been made.

ERS/ESICM/ESCMID/ALAT guidelines for the management of severe community-acquired pneumonia.

PURPOSE: Severe community-acquired pneumonia (sCAP) is associated with high morbidity and mortality, and whilst European and non-European guidelines are available for community-acquired pneumonia, there are no specific guidelines for sCAP. METHODS: The European Respiratory Society (ERS), European Society of Intensive Care Medicine (ESICM), European Society of Clinical Microbiology and Infectious Diseases (ESCMID), and Latin American Thoracic Association (ALAT) launched a task force to develop the first international guidelines for sCAP. The panel comprised a total of 18 European and four non-European experts, as well as two methodologists. Eight clinical questions for sCAP diagnosis and treatment were chosen to be addressed. Systematic literature searches were performed in several databases. Meta-analyses were performed for evidence synthesis, whenever possible. The quality of evidence was assessed with GRADE (Grading of Recommendations, Assessment, Development and Evaluation). Evidence to Decision frameworks were used to decide on the direction and strength of recommendations. RESULTS: Recommendations issued were related to diagnosis, antibiotics, organ support, biomarkers and co-adjuvant therapy. After considering the confidence in effect estimates, the importance of outcomes studied, desirable and undesirable consequences of treatment, cost, feasibility, acceptability of the intervention and implications to health equity, recommendations were made for or against specific treatment interventions. CONCLUSIONS: In these international guidelines, ERS, ESICM, ESCMID, and ALAT provide evidence-based clinical practice recommendations for diagnosis, empirical treatment, and antibiotic therapy for sCAP, following the GRADE approach. Furthermore, current knowledge gaps have been highlighted and recommendations for future research have been made.

Evidence-based guidelines for hypertension and diabetes in sub-Saharan Africa: a scoping review.

OBJECTIVE: The Collaboration for Evidence-Based Healthcare and Public Health in sub-Saharan Africa (CEBHA+), a research network, aims to build capacities for evidence-based healthcare. Hypertension (HTN) and diabetes mellitus (DM) are two priority areas of the network, both are major causes of burden of disease in this region. This review aimed to: (1) identify existing evidence-based guidelines for HTN and DM, (2) map their recommendations and (3) assess their quality. SETTING: Sub-Saharan Africa. DESIGN: Scoping review. METHODS: Systematic searches for evidence-based guidelines, developed with systematic review of evidence and certainty of evidence assessment, were undertaken in electronic databases and grey literature, and ministries of health of all countries in this region were contacted. Included guidelines were assessed with the Appraisal of Guidelines for research and evaluation II (AGREE-II) tool. Searches were conducted between 7 December 2021 and 14 January 2022. Results are presented descriptively. RESULTS: 66 potentially relevant guidelines were identified, developed in 23, out of 49 sub-Saharan African countries. Of these, only two guidelines (on DM) reported the use of systematic review of evidence and certainty of evidence assessment. Their quality appraisal showed that both have relatively similar scores on domains of AGREE-II, with higher scores on Scope and Purpose and Clarity and Presentation domains, and lower on Stakeholder Involvement, Applicability, Rigour of Development and Editorial independence domains. The overall scores of both guidelines were 50% and 58%, respectively. CONCLUSIONS: Less than half of the countries in sub-Saharan Africa developed and published their own guidelines for HTN or DM. The quality appraisal showed that the two included guidelines scored relatively low in several crucial domains of AGREE-II. Countries in this region could consider adopting or adapting already published high-quality recommendations, in order to facilitate a more efficient and faster development of much needed trustworthy evidence-based guidance.

Using GRADE Evidence to Decision frameworks to support the process of health policy-making: an example application regarding taxation of sugar-sweetened beverages.

BACKGROUND: Grading of Recommendations, Assessment, Development and Evaluation (GRADE) Evidence to Decision (EtD) frameworks are well-known tools that enable guideline panels to structure the process of developing recommendations and making decisions in healthcare and public health. To date, they have not regularly been used for health policy-making. This article aims to illustrate the application of the GRADE EtD frameworks in the process of nutrition-related policy-making for a European country. METHODS: Based on methodological guidance by the GRADE Working Group and the findings of our recently published scoping review, we illustrate the process of moving from evidence to recommendations, by applying the EtD frameworks to a fictitious example. Sugar-sweetened beverage (SSB) taxation based on energy density was chosen as an example application. RESULTS: A fictitious guideline panel was convened by a national nutrition association to develop a population-level recommendation on SSB taxation aiming to reduce the burden of overweight and obesity. Exemplary evidence was summarized for each EtD criterion and conclusions were drawn based on all judgements made in relation to each criterion. As a result of the high priority to reduce the burden of obesity and because of the moderate desirable effects on health outcomes, but considering scarce or varying research evidence for other EtD criteria, the panel made a conditional recommendation for SSB taxation. Decision-makers may opt for conducting a pilot study prior to implementing the policy on a national level. CONCLUSIONS: GRADE EtD frameworks can be used by guideline panels to make the process of developing recommendations in the field of health policy more systematic, transparent and comprehensible.

Pooling of cohort studies and RCTs affects GRADE certainty of evidence in nutrition research.

BACKGROUND: There is a little empirical evidence of the impact of pooling randomized controlled trials (RCTs) and cohort studies (CSs) on the certainty-of-evidence. To evaluate the hypothetical-scenario of pooling bodies-of-evidence from RCTs with matched bodies-of-evidence from CSs on the certainty-of-evidence. METHODS: We extracted GRADE ratings of bodies-of-evidence from RCTs in Cochrane reviews, and rated the certainty-of-evidence from matched bodies-of-evidence from CSs. We then evaluated the impact of pooling both bodies-of-evidence on the overall certainty-of-evidence, and on individual GRADE domains. RESULTS: Fourty-two pooled bodies-of-evidence were rated, ranging from very-low (bodies-of-evidenceRCTs: 9.5%; bodies-of-evidenceCSs: 40.5%; pooled-bodies-of-evidence: 0%) to low (bodies-of-evidenceRCTs: 38.1%; bodies-of-evidenceCSs: 45.2%; pooled-bodies-of-evidence: 19.1%), moderate (bodies-of-evidenceRCTs: 33.4%; bodies-of-evidenceCSs: 14.3%; pooled-bodies-of-evidence: 57.1%), and high (bodies-of-evidenceRCTs: 19%; bodies-of-evidenceCSs: 0%; pooled-bodies-of-evidence: 23.8%). Certainty-of-evidence was downgraded mostly for imprecision and risk of bias for bodies-of-evidence from RCTs, and for risk of bias and inconsistency for bodies-of-evidence from CSs. Pooling both bodies-of-evidence mitigates rating down for imprecision compared to bodies-of-evidence from RCTs and inconsistency compared to bodies-of-evidence from CSs. CONCLUSION: Our hypothetical study suggests that pooling both bodies-of-evidence would reduce the amount of very-low and low certainty-of-evidence ratings, but how to integrate RCTs and CSs and whether or not to pool these bodies-of-evidence requires proper guidance before systematic review authors or guideline developers should consider this approach.

European Respiratory Society clinical practice guidelines: methodological guidance.

ERS has published official methodological guidance for clinical practice guidelines. ERS recommends this to ensure that state-of-the-art guidelines are developed. https://bit.ly/3xP5SSr.

Effects of nutritional intervention strategies in the primary prevention of overweight and obesity in school settings: systematic review and network meta-analysis.

Objective: To examine the effects of different nutritional intervention strategies in the school setting on anthropometric and quality of diet outcomes by comparing and ranking outcomes in a network meta-analysis. Design: Systematic review and network meta-analysis. Data sources: PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), Web of Science, Education Resources Information Centre (ERIC), PsycInfo, CAB Abstracts, Campbell Library, Evidence for Policy and Practice Information and Co-ordinating Centre (EPPI-Centre) BiblioMap, Australian Education Index, Joanna Briggs Institute Evidence-Based Practice (JBI EBP) database, Practice-based Evidence in Nutrition (PEN) database, ClinicalTrials.gov, Current Controlled Trials, and World Health Organization International Clinical Trials Registry Platform. Eligibility criteria for selecting studies: A systematic literature search was performed from inception to 2 May 2022. Cluster randomised controlled trials meeting these study criteria were included: generally healthy school students aged 4-18 years; intervention with ≥1 nutritional components in a school setting; and studies that assessed anthropometric measures (eg, body mass index, body fat) or measures related to the quality of diet (eg, intake of fruit and vegetables), or both. Random effects pairwise meta-analyses and network meta-analyses were performed with a frequentist approach. P scores, a frequentist analogue to surface under the cumulative ranking curve, ranging from 0 to 1 (indicating worst and best ranked interventions, respectively) were calculated. Risk of bias was assessed with Cochrane's RoB 2 tool. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework was used to rate the certainty of evidence. Results: 51 cluster randomised controlled trials involving 75 954 participants and seven intervention nodes were included. Inconsistency could not be assessed (except for intake of fruit and vegetables) because the network meta-analyses were based mainly on star shaped networks with no direct evidence for specific pairs of nutritional interventions. Overall, little or no evidence was found to support a difference in body mass index, body weight, body fat, or waist circumference and moderate improvements in intake of fruit and vegetables with nutritional interventions in a school setting. Low to moderate certainty of evidence further suggested that multicomponent nutritional interventions likely reduced the prevalence (odds ratio 0.66, 95% confidence interval 0.55 to 0.80) and incidence (0.67, 0.47 to 0.96) of overweight compared with a control group. Based on low certainty of evidence, nutrition education and multicomponent interventions may be more effective than a control group (ie, usual practice) for increasing intake of fruit and vegetables. Multicomponent nutritional interventions were ranked the most effective for reducing body mass index (P score 0.76) and intake of fat (0.82). Nutrition education was ranked as best for body mass index z score (0.99), intake of fruit and vegetables (0.82), intake of fruit (0.92), and intake of vegetables (0.88). Conclusions: The findings suggest that nutritional interventions in school settings may improve anthropometric and quality of diet measures, potentially contributing to the prevention of overweight and obesity in childhood and adolescence. The findings should be interpreted with caution because the certainty of evidence was often rated as low. The results of the network meta-analysis could be used by policy makers in developing and implementing effective, evidence based nutritional intervention strategies in the school setting. Systematic review registration: PROSPERO CRD42020220451.

Efficacy and safety of strong opioids for chronic noncancer pain and chronic low back pain: a systematic review and meta-analyses.

ABSTRACT: In recent years, long-term prescribing and use of strong opioids for chronic noncancer pain (CNCP) has increased in high-income countries. Yet existing uncertainties, controversies, and differing recommendations make the rationale for prolonged opioid use in CNCP unclear. This systematic review and meta-analyses compared the efficacy, safety, and tolerability of strong opioids with placebo or nonopioid therapy in CNCP, with a special focus on chronic low back pain (CLBP). Systematic literature searches were performed in 4 electronic databases (MEDLINE, Web of Science, Cochrane Library, and CINAHL) in July 2019 and updated by regular alerts until December 2020. We included 16 placebo-controlled randomized controlled trials for CLBP and 5 studies (2 randomized controlled trials and 3 nonrandomized studies) of opioids vs nonopioids for CNCP in the quantitative and qualitative synthesis. Random effects pairwise meta-analyses were performed for efficacy, safety, and tolerability outcomes and subgroup analyses for treatment duration, study design, and opioid experience status. Very low to low certainty findings suggest that 4 to 15 weeks (short or intermediate term) opioid therapy in CLBP (compared with placebo) may cause clinically relevant reductions in pain but also more gastrointestinal and nervous system adverse events, with likely no effect on disability. By contrast, long-term opioid therapy (≥6 months) in CNCP may not be superior to nonopioids in improving pain or disability or pain-related function but seems to be associated with more adverse events, opioid abuse or dependence, and possibly an increase in all-cause mortality. Our findings also underline the importance and need for well-designed trials assessing long-term efficacy and safety of opioids for CNCP and CLBP.

Treatment Regimens for Immunocompetent Elderly Patients with Primary Central Nervous System Lymphoma: A Scoping Review.

BACKGROUND: Most patients diagnosed with primary central nervous system lymphoma (PCNSL) are older than 60 years. Despite promising treatment options for younger patients, prognosis for the elderly remains poor and efficacy of available treatment options is limited. MATERIALS AND METHODS: We conducted a scoping review to identify and summarize the current study pool available evaluating different types and combinations of (immuno) chemotherapy with a special focus on HCT-ASCT in elderly PCNSL. Relevant studies were identified through systematic searches in the bibliographic databases Medline, Web of Science, Cochrane Library and ScienceDirect (last search conducted in September 2020). For ongoing studies, we searched ClinicalTrials.gov, the German study register and the WHO registry. RESULTS: In total, we identified six randomized controlled trials (RCT) with 1.346 patients, 26 prospective (with 1.366 patients) and 24 retrospective studies (with 2.629 patients). Of these, only six studies (one completed and one ongoing RCT (with 447 patients), one completed and one ongoing prospective single arm study (with 65 patients), and two retrospective single arm studies (with 122 patients)) evaluated HCT-ASCT. Patient relevant outcomes such as progression-free and overall survival and (neuro-)toxicity were adequately considered across almost all studies. The current study pool is, however, not conclusive in terms of the most effective treatment options for elderly. Main limitations were (very) small sample sizes and heterogeneous patient populations in terms of age ranges (particularly in RCTs) limiting the applicability of the results to the target population (elderly). CONCLUSIONS: Although it has been shown that HCT-ASCT is probably a feasible and effective treatment option, this approach has never been investigated within a RCT including a wide range of elderly patients. A RCT comparing conventional (immuno) chemotherapy with HCT-ASCT is crucial to evaluate benefit and harms in an un-biased manner to eventually provide older PCNSL patients with the most effective treatment.

Evaluating agreement between bodies of evidence from randomised controlled trials and cohort studies in nutrition research: meta-epidemiological study.

OBJECTIVE: To evaluate the agreement between diet-disease effect estimates of bodies of evidence from randomised controlled trials and those from cohort studies in nutrition research, and to investigate potential factors for disagreement. DESIGN: Meta-epidemiological study. DATA SOURCES: Cochrane Database of Systematic Reviews, and Medline. REVIEW METHODS: Population, intervention or exposure, comparator, outcome (PI/ECO) elements from a body of evidence from cohort studies (BoE(CS)) were matched with corresponding elements of a body of evidence from randomised controlled trials (BoE(RCT)). Pooled ratio of risk ratios or difference of mean differences across all diet-disease outcome pairs were calculated. Subgroup analyses were conducted to explore factors for disagreement. Heterogeneity was assessed through I2 and τ2. Prediction intervals were calculated to assess the range of possible values for the difference in the results between evidence from randomised controlled trials and evidence from cohort studies in future comparisons. RESULTS: 97 diet-disease outcome pairs (that is, matched BoE(RCT) and BoE(CS)) were identified overall. For binary outcomes, the pooled ratio of risk ratios comparing estimates from BoE(RCT) with BoE(CS) was 1.09 (95% confidence interval 1.04 to 1.14; I2=68%; τ2=0.021; 95% prediction interval 0.81 to 1.46). The prediction interval indicated that the difference could be much more substantial, in either direction. We further explored heterogeneity and found that PI/ECO dissimilarities, especially for the comparisons of dietary supplements in randomised controlled trials and nutrient status in cohort studies, explained most of the differences. When the type of intake or exposure between both types of evidence was identical, the estimates were similar. For continuous outcomes, small differences were observed between randomised controlled trials and cohort studies. CONCLUSION: On average, the difference in pooled results between estimates from BoE(RCT) and BoE(CS) was small. But wide prediction intervals and some substantial statistical heterogeneity in cohort studies indicate that important differences or potential bias in individual comparisons or studies cannot be excluded. Observed differences were mainly driven by dissimilarities in population, intervention or exposure, comparator, and outcome. These findings could help researchers further understand the integration of such evidence into prospective nutrition evidence syntheses and improve evidence based dietary guidelines.