Publications by authors named "Rebecca L Morgan"

93 Publications

Applying evidence-based methods to the development and use of adverse outcome pathways.

ALTEX 2021 Apr 8. Epub 2021 Apr 8.

Evidence-Based Toxicology Collaboration (EBTC) at Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.

The workshop "Application of evidence-based methods to construct mechanistic frameworks for the development and use of non-animal toxicity tests" was organized by the Evidence-based Toxicology Collaboration and hosted by the Grading of Recommendations Assessment, Development and Evaluation Working Group on June 12, 2019. The purpose of the workshop was to bring together international regulatory bodies, risk assessors, academic scientists, and industry to explore how systematic review methods and the adverse outcome pathway framework could be combined to develop and use mechanistic test methods for predicting the toxicity of chemical substances in an evidence-based manner. The meeting covered the history of biological frameworks, the way adverse outcome pathways are currently developed, the basic principles of systematic methodology, including systematic reviews and evidence maps, and assessment of certainty in models, and adverse outcome pathways in particular. Specific topics were discussed via case studies in small break-out groups. The group concluded that adverse outcome pathways provide an important framework to support mechanism-based assessment in environmental health. The process of their development has a few challenges that could be addressed with systematic methods and automation tools. Addressing these challenges will increase the transparency of the evidence behind adverse outcome pathways and the consistency with which they are defined; this in turn will increase their value for supporting public health decisions. It was suggested to explore the details of applying systematic methods to adverse outcome pathway development in a series of case studies and workshops.
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http://dx.doi.org/10.14573/altex.2101211DOI Listing
April 2021

Reply to Letters to the Editor on Probiotic Guidelines.

Gastroenterology 2021 Feb 24. Epub 2021 Feb 24.

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

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http://dx.doi.org/10.1053/j.gastro.2021.02.046DOI Listing
February 2021

Standardisation of Clinical Assessment, Management and Follow-Up of Acute Hospitalised Exacerbation of COPD: A Europe-Wide Consensus.

Int J Chron Obstruct Pulmon Dis 2021 16;16:321-332. Epub 2021 Feb 16.

Respiratory Medicine Unit, Nuffield Department of Medicine - Experimental Medicine, University of Oxford, Oxford, UK.

Background: Despite hospitalization for exacerbation being a high-risk event for morbidity and mortality, there is little consensus globally regarding the assessment and management of hospitalised exacerbations of COPD. We aimed to establish a consensus list of symptoms, physiological measures, clinical scores, patient questionnaires and investigations to be obtained at time of hospitalised COPD exacerbation and follow-up.

Methods: A modified Delphi online survey with pre-defined consensus of importance, feasibility and frequency of measures at hospitalisation and follow-up of a COPD exacerbation was undertaken.

Findings: A total of 25 COPD experts from 18 countries contributed to all 3 rounds of the survey. Experts agreed that a detailed history and examination were needed. Experts also agreed on which treatments are needed and how soon these should be delivered. Experts recommended that a full blood count, renal function, C-reactive protein and cardiac blood biomarkers (BNP and troponin) should be measured within 4 hours of admission and that the modified Medical Research Council dyspnoea scale (mMRC) and COPD assessment test (CAT) should be performed at time of exacerbation and follow-up. Experts encouraged COPD clinicians to strongly consider discussing palliative care, if indicated, at time of hospitalisation.

Interpretation: This Europe-wide consensus document is the first attempt to standardise the assessment and care of patients hospitalised for COPD exacerbations. This should be regarded as the starting point to build knowledge and evidence on patients hospitalised for COPD exacerbations.
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http://dx.doi.org/10.2147/COPD.S287705DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7896731PMC
February 2021

American Society of Hematology 2021 guidelines for management of venous thromboembolism: prevention and treatment in patients with cancer.

Blood Adv 2021 Feb;5(4):927-974

Cochrane Iberoamérica, Biomedical Research Institute Sant Pau-CIBERESP, Barcelona, Spain.

Background: Venous thromboembolism (VTE) is a common complication among patients with cancer. Patients with cancer and VTE are at a markedly increased risk for morbidity and mortality.

Objective: These evidence-based guidelines of the American Society of Hematology (ASH) are intended to support patients, clinicians, and other health care professionals in their decisions about the prevention and treatment of VTE in patients with cancer.

Methods: ASH formed a multidisciplinary guideline panel balanced to minimize potential bias from conflicts of interest. The guideline development process was supported by updated or new systematic evidence reviews. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach was used to assess evidence and make recommendations.

Results: Recommendations address mechanical and pharmacological prophylaxis in hospitalized medical patients with cancer, those undergoing a surgical procedure, and ambulatory patients receiving cancer chemotherapy. The recommendations also address the use of anticoagulation for the initial, short-term, and long-term treatment of VTE in patients with cancer.

Conclusions: Strong recommendations include not using thromboprophylaxis in ambulatory patients receiving cancer chemotherapy at low risk of VTE and to use low-molecular-weight heparin (LMWH) for initial treatment of VTE in patients with cancer. Conditional recommendations include using thromboprophylaxis in hospitalized medical patients with cancer, LMWH or fondaparinux for surgical patients with cancer, LMWH or direct oral anticoagulants (DOAC) in ambulatory patients with cancer receiving systemic therapy at high risk of VTE and LMWH or DOAC for initial treatment of VTE, DOAC for the short-term treatment of VTE, and LMWH or DOAC for the long-term treatment of VTE in patients with cancer.
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http://dx.doi.org/10.1182/bloodadvances.2020003442DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7903232PMC
February 2021

The Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19: Molecular Diagnostic Testing.

Clin Infect Dis 2021 Jan 22. Epub 2021 Jan 22.

Division of Nephrology and Hypertension, Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.

Background: Accurate molecular diagnostic tests are necessary for confirming a diagnosis of coronavirus disease 2019 (COVID-19). Direct detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acids in respiratory tract specimens informs patient, healthcare institution and public health level decision-making. The numbers of available SARS-CoV-2 nucleic acid detection tests are rapidly increasing, as is the COVID-19 diagnostic literature. Thus, the Infectious Diseases Society of America (IDSA) recognized a significant need for frequently updated systematic reviews of the literature to inform evidence-based best practice guidance.

Objective: The IDSA's goal was to develop an evidence-based diagnostic guideline to assist clinicians, clinical laboratorians, patients and policymakers in decisions related to the optimal use of SARS-CoV-2 nucleic acid amplification tests. In addition, we provide a conceptual framework for understanding molecular diagnostic test performance, discuss the nuance of test result interpretation in a variety of practice settings and highlight important unmet research needs in the COVID-19 diagnostic testing space.

Methods: IDSA convened a multidisciplinary panel of infectious diseases clinicians, clinical microbiologists, and experts in systematic literature review to identify and prioritize clinical questions and outcomes related to the use of SARS-CoV-2 molecular diagnostics. Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology was used to assess the certainty of evidence and make testing recommendations.

Results: The panel agreed on 17 diagnostic recommendations.

Conclusions: Universal access to accurate SARS-CoV-2 nucleic acid testing is critical for patient care, hospital infection prevention and the public response to the COVID-19 pandemic. Information on the clinical performance of available tests is rapidly emerging, but the quality of evidence of the current literature is considered moderate to very low. Recognizing these limitations, the IDSA panel weighed available diagnostic evidence and recommends nucleic acid testing for all symptomatic individuals suspected of having COVID-19. In addition, testing is recommended for asymptomatic individuals with known or suspected contact with a COVID-19 case. Testing asymptomatic individuals without known exposure is suggested when the results will impact isolation/quarantine/personal protective equipment (PPE) usage decisions, dictate eligibility for surgery, or inform solid organ or hematopoietic stem cell transplantation timing. Ultimately, prioritization of testing will depend on institutional-specific resources and the needs of different patient populations.
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http://dx.doi.org/10.1093/cid/ciab048DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7929045PMC
January 2021

Challenges in applying the GRADE approach in public health guidelines and systematic reviews: a concept article from the GRADE Public Health Group.

J Clin Epidemiol 2021 Jan 18;135:42-53. Epub 2021 Jan 18.

MRC/CSO Social and Public Health Sciences Unit, Berkeley Square, 99 Berkeley Street, University of Glasgow, Glasgow G3 7HR, UK.

Background And Objective: This article explores the need for conceptual advances and practical guidance in the application of the GRADE approach within public health contexts.

Methods: We convened an expert workshop and conducted a scoping review to identify challenges experienced by GRADE users in public health contexts. We developed this concept article through thematic analysis and an iterative process of consultation and discussion conducted with members electronically and at three GRADE Working Group meetings.

Results: Five priority issues can pose challenges for public health guideline developers and systematic reviewers when applying GRADE: (1) incorporating the perspectives of diverse stakeholders; (2) selecting and prioritizing health and "nonhealth" outcomes; (3) interpreting outcomes and identifying a threshold for decision-making; (4) assessing certainty of evidence from diverse sources, including nonrandomized studies; and (5) addressing implications for decision makers, including concerns about conditional recommendations. We illustrate these challenges with examples from public health guidelines and systematic reviews, identifying gaps where conceptual advances may facilitate the consistent application or further development of the methodology and provide solutions.

Conclusion: The GRADE Public Health Group will respond to these challenges with solutions that are coherent with existing guidance and can be consistently implemented across public health decision-making contexts.
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http://dx.doi.org/10.1016/j.jclinepi.2021.01.001DOI Listing
January 2021

Use of Ebola Vaccine: Recommendations of the Advisory Committee on Immunization Practices, United States, 2020.

MMWR Recomm Rep 2021 01 8;70(1):1-12. Epub 2021 Jan 8.

This report summarizes the recommendations of the Advisory Committee on Immunization Practices (ACIP) for use of the rVSVΔG-ZEBOV-GP Ebola vaccine (Ervebo) in the United States. The vaccine contains rice-derived recombinant human serum albumin and live attenuated recombinant vesicular stomatitis virus (VSV) in which the gene encoding the glycoprotein of VSV was replaced with the gene encoding the glycoprotein of Ebola virus species Zaire ebolavirus. Persons with a history of severe allergic reaction (e.g., anaphylaxis) to rice protein should not receive Ervebo. This is the first and only vaccine currently licensed by the Food and Drug Administration for the prevention of Ebola virus disease (EVD). These guidelines will be updated based on availability of new data or as new vaccines are licensed to protect against EVD.ACIP recommends preexposure vaccination with Ervebo for adults aged ≥18 years in the U.S. population who are at highest risk for potential occupational exposure to Ebola virus species Zaire ebolavirus because they are responding to an outbreak of EVD, work as health care personnel at federally designated Ebola treatment centers in the United States, or work as laboratorians or other staff at biosafety level 4 facilities in the United States. Recommendations for use of Ervebo in additional populations at risk for exposure and other settings will be considered and discussed by ACIP in the future.
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http://dx.doi.org/10.15585/mmwr.rr7001a1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7802368PMC
January 2021

The prevalence of occupational exposure to ergonomic risk factors: A systematic review and meta-analysis from the WHO/ILO Joint Estimates of the Work-related Burden of Disease and Injury.

Environ Int 2021 Jan 14;146:106157. Epub 2020 Dec 14.

Amsterdam UMC, University of Amsterdam, Department Public and Occupational Health, Coronel Institute of Occupational Health, Amsterdam Public Health Research Institute, Amsterdam, the Netherlands. Electronic address:

Background: The World Health Organization (WHO) and the International Labour Organization (ILO) are developing joint estimates of the work-related burden of disease and injury (WHO/ILO Joint Estimates), with contributions from a large network of experts. Evidence from mechanistic and human data suggests that occupational exposure to ergonomic (or physical) risk factors may cause osteoarthritis and other musculoskeletal diseases (excluding rheumatoid arthritis, gout, and back and neck pain). In this paper, we present a systematic review and meta-analysis of the prevalence of occupational exposure to physical ergonomic risk factors for estimating the number of disability-adjusted life years from these diseases that are attributable to exposure to this risk factor, for the development of the WHO/ILO Joint Estimates.

Objectives: We aimed to systematically review and meta-analyse estimates of the prevalence of occupational exposure to ergonomic risk factors for osteoarthritis and other musculoskeletal diseases.

Data Sources: We searched electronic bibliographic databases for potentially relevant records from published and unpublished studies, including Ovid Medline, EMBASE, and CISDOC. We also searched electronic grey literature databases, Internet search engines and organizational websites; hand-searched reference list of previous systematic reviews and included study records; and consulted additional experts.

Study Eligibility And Criteria: We included working-age (≥15 years) workers in the formal and informal economy in any WHO and/or ILO Member State but excluded children (<15 years) and unpaid domestic workers. The exposure was defined as any occupational exposure to one or more of: force exertion, demanding posture, repetitive movement, hand-arm vibration, kneeling or squatting, lifting, and/or climbing. We included all study types with an estimate of the prevalence of occupational exposure to ergonomic risk factors.

Study Appraisal And Synthesis Methods: At least two review authors independently screened titles and abstracts against the eligibility criteria at a first stage and full texts of potentially eligible records at a second stage, followed by extraction of data from qualifying studies. We combined prevalence estimates using random-effect meta-analysis. Two or more review authors assessed the risk of bias and the quality of evidence, using the ROB-SPEO tool and QoE-SPEO approach developed specifically for the WHO/ILO Joint Estimates.

Results: Five studies (three cross-sectional studies and two cohort studies) met the inclusion criteria, comprising 150,895 participants (81,613 females) in 36 countries in two WHO regions (Africa, Europe). The exposure was generally assessed with questionnaire data about self-reported exposure. Estimates of the prevalence of occupational exposure to ergonomic risk factors are presented for all five included studies, disaggregated by country, sex, 5-year age group, industrial sector or occupational group where feasible. The pooled prevalence of any occupational exposure to ergonomic risk factors was 0.76 (95% confidence interval 0.69 to 0.84, 3 studies, 148,433 participants, 35 countries in the WHO Europe region, I 100%, low quality of evidence). Subgroup analyses found no statistically significant differences in exposure by sex but differences by age group, occupation and country. No evidence was found for publication bias. We assessed this body evidence to be of low quality, based on serious concerns for risk of bias due to exposure assessment only being based on self-report and for indirectness due to evidence from two WHO regions only.

Conclusions: Our systematic review and meta-analysis found that occupational exposure to ergonomic risk factors is highly prevalent. The current body of evidence is, however, limited, especially by risk of bias and indirectness. Producing estimates for the burden of disease attributable to occupational exposure to ergonomic risk factors appears evidence-based, and the pooled effect estimates presented in this systematic review may perhaps be used as input data for the WHO/ILO Joint Estimates. Protocol identifier:https://doi.org/10.1016/j.envint.2018.09.053. PROSPERO registration number: CRD42018102631.
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http://dx.doi.org/10.1016/j.envint.2020.106157DOI Listing
January 2021

The Advisory Committee on Immunization Practices' Interim Recommendation for Use of Moderna COVID-19 Vaccine - United States, December 2020.

MMWR Morb Mortal Wkly Rep 2021 Jan 1;69(5152):1653-1656. Epub 2021 Jan 1.

On December 18, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Moderna COVID-19 (mRNA-1273) vaccine (ModernaTX, Inc; Cambridge, Massachusetts), a lipid nanoparticle-encapsulated, nucleoside-modified mRNA vaccine encoding the stabilized prefusion spike glycoprotein of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19) (1). This vaccine is the second COVID-19 vaccine authorized under an EUA for the prevention of COVID-19 in the United States (2). Vaccination with the Moderna COVID-19 vaccine consists of 2 doses (100 μg, 0.5 mL each) administered intramuscularly, 1 month (4 weeks) apart. On December 19, 2020, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation* for use of the Moderna COVID-19 vaccine in persons aged ≥18 years for the prevention of COVID-19. To guide its deliberations regarding the vaccine, ACIP employed the Evidence to Recommendation (EtR) Framework, using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Use of all COVID-19 vaccines authorized under an EUA, including the Moderna COVID-19 vaccine, should be implemented in conjunction with ACIP's interim recommendations for allocating initial supplies of COVID-19 vaccines (3). The ACIP recommendation for the use of the Moderna COVID-19 vaccine under EUA is interim and will be updated as additional information becomes available.
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http://dx.doi.org/10.15585/mmwr.mm695152e1DOI Listing
January 2021

Preparation of a User-Defined Peptide Gel for Controlled 3D Culture Models of Cancer and Disease.

J Vis Exp 2020 12 3(166). Epub 2020 Dec 3.

Division of Cancer & Stem Cells, School of Medicine, Nottingham Biodiscovery Institute, University of Nottingham;

There is a growing awareness that cells grown in 3D better model in vivo behavior than those grown in 2D. In this protocol, we describe a simple and tunable 3D hydrogel, suitable for culturing cells and tissue in a setting that matches their native environment. This is particularly important for researchers investigating the initiation, growth, and treatment of cancer where the interaction between cells and their local extracellular matrix is a fundamental part of the model. Moving to 3D culture can be challenging and is often associated with a lack of reproducibility due to high batch-to-batch variation in animal-derived 3D culture matrices. Similarly, handling issues can limit the usefulness of synthetic hydrogels. In response to this need, we have optimized a simple self-assembling peptide gel, to enable the culture of relevant cell line models of cancer and disease, as well as patient-derived tissue/cells. The gel itself is free from matrix components, apart from those added during encapsulation or deposited into the gel by the encapsulated cells. The mechanical properties of the hydrogels can also be altered independent of matrix addition. It, therefore, acts as a 'blank slate' allowing researchers to build a 3D culture environment that reflects the target tissue of interest and to dissect the influences of mechanical forces and/or biochemical control of cell behavior independently.
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http://dx.doi.org/10.3791/61710DOI Listing
December 2020

The Advisory Committee on Immunization Practices' Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine - United States, December 2020.

MMWR Morb Mortal Wkly Rep 2020 Dec 18;69(50):1922-1924. Epub 2020 Dec 18.

On December 11, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 (BNT162b2) vaccine (Pfizer, Inc; Philadelphia, Pennsylvania), a lipid nanoparticle-formulated, nucleoside-modified mRNA vaccine encoding the prefusion spike glycoprotein of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19) (1). Vaccination with the Pfizer-BioNTech COVID-19 vaccine consists of 2 doses (30 μg, 0.3 mL each) administered intramuscularly, 3 weeks apart. On December 12, 2020, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation* for use of the Pfizer-BioNTech COVID-19 vaccine in persons aged ≥16 years for the prevention of COVID-19. To guide its deliberations regarding the vaccine, ACIP employed the Evidence to Recommendation (EtR) Framework, using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. The recommendation for the Pfizer-BioNTech COVID-19 vaccine should be implemented in conjunction with ACIP's interim recommendation for allocating initial supplies of COVID-19 vaccines (2). The ACIP recommendation for the use of the Pfizer-BioNTech COVID-19 vaccine under EUA is interim and will be updated as additional information becomes available.
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http://dx.doi.org/10.15585/mmwr.mm6950e2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7745957PMC
December 2020

Management of heparin-induced thrombocytopenia: systematic reviews and meta-analyses.

Blood Adv 2020 10;4(20):5184-5193

Department of Health Research Methods, Evidence and Impact, and.

Heparin-induced thrombocytopenia (HIT) is a prothrombotic adverse drug reaction occurring in <0.1% to 7% of patients receiving heparin products depending on the patient population and type of heparin. Management of HIT is highly dependent on a sequence of tests for which clinicians may or may not have the results when care decisions need to be made. We conducted systematic reviews of the effects of management strategies in persons with acute HIT, subacute HIT A or B, and remote HIT. We searched Medline, EMBASE, and the Cochrane Database through July 2019 for previously published systematic reviews and primary studies. Two investigators independently screened and extracted data and assessed the certainty of the evidence using the Grading of Recommendations Assessment, Development and Evaluation approach. We found primarily noncomparative studies and case series assessing effects of treatments, which led to low to very low certainty evidence. There may be little to no difference in the effects between nonheparin parenteral anticoagulants and direct oral anticoagulants in acute HIT. The benefits of therapeutic-intensity may be greater than prophylactic-intensity anticoagulation. Using inferior vena cava filters or platelet transfusion may result in greater harm than not using these approaches. Evidence for management in special situations, such as for patients undergoing cardiovascular interventions or renal replacement therapy, was also low to very low certainty. Additional research to evaluate nonheparin anticoagulants is urgently needed, and the development of novel treatments that reduce thrombosis without increasing hemorrhage should be a priority.
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http://dx.doi.org/10.1182/bloodadvances.2020002963DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7594379PMC
October 2020

ONS Guidelines™ for Opioid-Induced and Non-Opioid-Related Cancer Constipation.

Oncol Nurs Forum 2020 11;47(6):671-691

McMaster University.

Purpose: This evidence-based guideline intends to support clinicians, patients, and others in decisions regarding the treatment of constipation in patients with cancer.

Methodologic Approach: An interprofessional panel of healthcare professionals with patient representation prioritized clinical questions and patient outcomes for the management of cancer-related constipation. Systematic reviews of the literature were conducted. The GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach was used to assess the evidence and make recommendations.

Findings: The panel agreed on 13 recommendations for the management of opioid-induced and non-opioid-related constipation in patients with cancer.

Implications For Nursing: The panel conditionally recommended a bowel regimen in addition to lifestyle education as first-line treatment for constipation. For patients starting opioids, the panel suggests a bowel regimen as prophylaxis. Pharmaceutical interventions are available and recommended if a bowel regimen has failed. Acupuncture and electroacupuncture for non-opioid-related constipation are recommended in the context of a clinical trial.

Supplementary Material Can Be Found At https: //bit.ly/30y29sI.
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http://dx.doi.org/10.1188/20.ONF.671-691DOI Listing
November 2020

ONS Guidelines™ for Cancer Treatment-Related Radiodermatitis.

Oncol Nurs Forum 2020 11;47(6):654-670

McMaster University.

Purpose: Radiodermatitis is a side effect of radiation therapy. Evidence-based interventions to minimize severity or delay progression are important for clinical care. This guideline intends to support individuals with cancer, clinicians, and others in decisions regarding radiodermatitis treatment.

Methodologic Approach: A panel of healthcare professionals with patient representation was convened to develop a national clinical practice guideline for the management of radiodermatitis. GRADE (Grading of Recommendations Assessment, Development and Evaluation) methodology and the National Academies of Sciences, Engineering, and Medicine criteria for trustworthy guidelines were followed. The Cochrane Collaboration risk-of-bias tool was used, and certainty of the evidence was assessed using the GRADE approach. A quantitative and narrative synthesis of the evidence was completed.

Findings: The panel agreed on eight recommendations and made a conditional recommendation for deodorant/antiperspirant. Aloe vera and oral curcumin had knowledge gaps and were recommended only in the context of a clinical trial. The panel suggested against emu oil, calendula, and nonsteroidal interventions.

Implications For Nursing: This guideline summarizes evidence-based interventions for the management of radiodermatitis to guide clinical care.

Supplementary Material Can Be Found At https: //bit.ly/2GEwJtT.
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http://dx.doi.org/10.1188/20.ONF.654-670DOI Listing
November 2020

Radiodermatitis in Patients With Cancer: Systematic Review and Meta-Analysis.

Oncol Nurs Forum 2020 11;47(6):E225-E236

McMaster University.

Problem Identification: A systematic review and meta-analysis was conducted to inform the development of guidelines on the management of radiodermatitis among patients with cancer.

Literature Search: The authors updated a systematic review to include available literature published through September 30, 2019.

Data Evaluation: Two investigators assessed risk of bias using the Cochrane Collaboration risk-of-bias tool and certainty of the evidence using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach.

Synthesis: The use of deodorant/antiperspirant had no effect on development of radiodermatitis. Aloe vera and emu oil were equivalent or less effective than standard care. Oral curcumin had a minimal beneficial effect. Nonsteroidal topical interventions had a minimal beneficial effect on the development of moist desquamation and relief of itching while causing a small increase for grade 2 radiodermatitis. Topical calendula increased risk for the development of radiodermatitis. Topical steroids and dressings each showed benefits to minimize the development of radiodermatitis and moist desquamation while lowering rates of patient-reported symptoms, such as pain and pruritus.

Implications For Research: Symptom management strategies for radiodermatitis among patients with cancer that are likely to be effective include topical nonsteroidals, topical steroids, and dressings.

Supplemental Material Can Be Found At https: //bit.ly/2FWj3Kp.
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http://dx.doi.org/10.1188/20.ONF.E225-E236DOI Listing
November 2020

Management of Opioid-Induced and Non-Opioid-Related Constipation in Patients With Cancer: Systematic Review and Meta-Analysis.

Oncol Nurs Forum 2020 11;47(6):E211-E224

McMaster University.

Problem Identification: A systematic review and meta-analysis was conducted to inform the development of national clinical practice guidelines on the management of cancer constipation.

Literature Search: PubMed®, Wiley Cochrane Library, and CINAHL® were searched for studies published from May 2009 to May 2019.

Data Evaluation: Two investigators independently reviewed and extracted data from eligible studies. The Cochrane Collaboration risk-of-bias tool was used, and the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach was used to assess the certainty of the evidence.

Synthesis: For patients with cancer and opioid-induced constipation, moderate benefit was found for osmotic or stimulant laxatives; small benefit was found for methylnaltrexone, naldemedine, and electroacupuncture. For patients with cancer and non-opioid-related constipation, moderate benefit was found for naloxegol, prucalopride, lubiprostone, and linaclotide; trivial benefit was found for acupuncture.

Implications For Practice: Effective strategies for managing opioid-induced and non-opioid-related constipation in patients with cancer include lifestyle, pharmacologic, and complementary approaches.

Supplemental Material Can Be Found At https: //bit.ly/3c4yewT.
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http://dx.doi.org/10.1188/20.ONF.E211-E224DOI Listing
November 2020

Systematic review and meta-analysis on exposure to long working hours and risk of ischaemic heart disease - Conclusions are supported by the evidence.

Environ Int 2020 11 10;144:106118. Epub 2020 Oct 10.

Life Science Centre, University of Düsseldorf, Merowingerplatz 1a, Düsseldorf 40225, Germany. Electronic address:

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http://dx.doi.org/10.1016/j.envint.2020.106118DOI Listing
November 2020

Assessing the process and outcome of the development of practice guidelines and recommendations: PANELVIEW instrument development.

CMAJ 2020 Oct;192(40):E1138-E1145

Department of Health Research Methods, Evidence, and Impact (Wiercioch, Akl, Santesso, Zhang, Morgan, Baldeh, Mustafa, Etxeandia-Ikobaltzeta, Carrasco-Labra, Ventresca, Brignardello-Petersen, Morgano, Brożek, Schünemann), McMaster University, Hamilton, Ont.; Department of Internal Medicine (Akl), American University of Beirut, Beirut, Lebanon; School of Medicine (Yepes-Nuñez), Universidad de los Andes, Bogotá, Colombia; Department of Internal Medicine (Kowalski), Federal University of Paraná, Curitiba, Brazil; Division of Nephrology and Hypertension (Mustafa), Department of Medicine, University of Kansas Medical Center, Kansas City, Kan.; Guideline Development Group (Laisaar), Faculty of Medicine, Institute of Family Medicine and Public Health, University of Tartu, Tartu, Estonia; Ministry of Social Affairs (Raid), Tallinn, Estonia; Department of Internal Medicine (Neumann), Pontificia Universidad Católica de Chile, Santiago, Chile; Federal University of Rio Grande do Sul (Falavigna), Institute for Health Technology Assessment, Porto Alegre, Brazil; Department of Medicine (Brożek, Schünemann), McMaster University, Hamilton, Ont.; Department of Innovation in Medical Education (McConnell), University of Ottawa, Ottawa, Ont.

Background: Guideline recommendations may be affected by flaws in the process, inappropriate panel member selection or conduct, conflicts of interest and other factors. To our knowledge, no validated tool exists to evaluate guideline development from the perspective of those directly involved in the process. Our objective was to develop and validate a universal tool, the PANELVIEW instrument, to assess guideline processes, methods and outcomes from the perspective of the participating guideline panellists and group members.

Methods: We performed a systematic literature search and surveys of guideline groups (identified through contacting international organizations and convenience sampling of working panels) to inform item generation. Subsequent groups of guideline methodologists and panellists reviewed items for face validity and missing items. We used surveys, interviews and expert review for item reduction and phrasing. For reliability assessment and feedback, we tested the PANELVIEW tool in 8 international guideline groups.

Results: We surveyed 62 members from 13 guideline panels, contacted 19 organizations and reviewed 20 source documents to generate items. Fifty-three additional key informants provided feedback about phrasing of the items and response options. We reduced the number of items from 95 to 34 across domains that included administration, training, conflict of interest, group dynamics, chairing, evidence synthesis, formulating recommendations and publication. The tool takes about 10 minutes to complete and showed acceptable measurement properties.

Interpretation: The PANELVIEW instrument fills a gap by enabling guideline organizations to involve clinicians, patients and other participants in evaluating their guideline processes. The tool can inform quality improvement of existing or new guideline programs, focusing on insight into and transparency of the guideline development process, methods and outcomes.
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http://dx.doi.org/10.1503/cmaj.200193DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7546748PMC
October 2020

Developing trustworthy recommendations as part of an urgent response (1-2 weeks): a GRADE concept paper.

J Clin Epidemiol 2021 Jan 30;129:1-11. Epub 2020 Sep 30.

Department of Health Research Methods, Evidence, and Impact, McMaster University, McMaster University Medical Centre, 1280 Main Street West, Hamilton, Ontario L8S 4K1, Canada.

Objectives: The aim of this study is to propose an approach for developing trustworthy recommendations as part of urgent responses (1-2 week) in the clinical, public health, and health systems fields.

Study Design And Setting: We conducted a review of the literature, outlined a draft approach, refined the concept through iterative discussions, a workshop by the Grading of Recommendations Assessment, Development and Evaluation Rapid Guidelines project group, and obtained feedback from the larger Grading of Recommendations Assessment, Development and Evaluation working group.

Results: A request for developing recommendations within 2 week is the usual trigger for an urgent response. Although the approach builds on the general principles of trustworthy guideline development, we highlight the following steps: (1) assess the level of urgency; (2) assess feasibility; (3) set up the organizational logistics; (4) specify the question(s); (5) collect the information needed; (6) assess the adequacy of identified information; (7) develop the recommendations using one of the 4 potential approaches: adopt existing recommendations, adapt existing recommendations, develop new recommendations using existing adequate systematic review, or develop new recommendations using expert panel input; and (8) consider an updating plan.

Conclusion: An urgent response for developing recommendations requires building a cohesive, skilled, and highly motivated multidisciplinary team with the necessary clinical, scientific, and methodological expertise; adapting to shifting needs; complying with the principles of transparency; and properly managing conflicts of interest.
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http://dx.doi.org/10.1016/j.jclinepi.2020.09.037DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7526592PMC
January 2021

The quality of physical activity guidelines, but not the specificity of their recommendations, has improved over time: a systematic review and critical appraisal.

Appl Physiol Nutr Metab 2021 Jan 29;46(1):34-45. Epub 2020 Sep 29.

Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON L8S 4K1, Canada.

While numerous guidelines for the prescription of physical activity are released each year, the quality and practicability of these guidelines is unknown. We assessed the quality of 95 guidance documents published since 2000 that included recommendations about physical activity for the promotion of general health and prevention of cardiometabolic disease. We used 3 tools: Appraisal of Guidelines for Research and Evaluation (AGREE II), the National Academy of Medicine's (NAM) Standards for Trustworthy Clinical Practice Guidelines, and the Frequency, Intensity, Time, and Type (FITT) score. Average AGREE II domain scores ranged from 38%-84%, and the portion of criteria fulfilled per NAM domain ranged from 7%-39%. The average FITT score for all recommendations was 2.48 out of 4. While guidelines improved according to both AGREE II and the NAM standards over time, their practicability as assessed by FITT score did not improve. Guidelines produced by governmental agencies or other nonprofit organizations, using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach, or fulfilling a higher number of NAM criteria tended to be of higher quality. Organizations producing physical activity guidelines can improve their quality by establishing and reporting processes for public representation, external review, and conflict of interest (COI) management. Future recommendations about physical activity should be more specific and include strategies to improve implementation. Registration no.: PROSPERO CRD42019126364. Most physical activity recommendations are not sufficiently specific to be practically implemented. The overall quality of guidelines has improved over time, but the specificity of recommendations has not. Improved public representation, external review, and COI disclosure and management processes would improve guideline quality.
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http://dx.doi.org/10.1139/apnm-2020-0378DOI Listing
January 2021

The effect of occupational exposure to welding fumes on trachea, bronchus and lung cancer: A protocol for a systematic review and meta-analysis from the WHO/ILO Joint Estimates of the Work-related Burden of Disease and Injury.

Environ Int 2020 12 17;145:106089. Epub 2020 Sep 17.

School of Community Health Sciences, University of Nevada, Reno, Reno, NV, United States.

Background: The World Health Organization (WHO) and the International Labour Organization (ILO) are developing joint estimates of the work-related burden of disease and injury (WHO/ILO Joint Estimates), with contributions from a large network of experts. Welding fumes have been classified as carcinogenic to humans (Group 1) by the International Agency for Research on Cancer (IARC); this assessment found sufficient evidence from studies in humans that welding fumes are a cause of lung cancer. In this article, we present the protocol for a systematic review of parameters for estimating the number of deaths and disability-adjusted life years from trachea, bronchus and lung cancer attributable to occupational exposure to welding fumes, to inform the development of the WHO/ILO Joint Estimates.

Objectives: We aim to systematically review and meta-analyse estimates of the effect of occupational exposure to welding fumes on trachea, bronchus and lung cancer, applying the Navigation Guide systematic review methodology as an organizing framework.

Data Sources: We will search electronic bibliographic databases for potentially relevant records from published and unpublished studies, including Medline, EMBASE, Web of Science, and CISDOC. We will also search electronic grey literature databases, Internet search engines and organizational websites; hand search reference list of previous systematic reviews and included study records; and consult additional experts.

Study Eligibility And Criteria: We will include working-age (≥15 years) workers in the formal and informal economy in any Member State of WHO and/or ILO but exclude children (<15 years) and unpaid domestic workers. The eligible risk factor will be occupational exposure to welding fumes, measured directly or indirectly (i.e., through proxy of relevant occupation, work task, job-exposure matrix, expert judgment or self-report). The eligible outcomes will be trachea, bronchus and lung cancer. We will include randomized controlled trials, cohort studies, case-control studies and other non-randomized intervention studies with an estimate of the relative effect of any occupational exposure to welding fumes on the prevalence of, incidence of or mortality from trachea, bronchus and lung cancer, compared with the theoretical minimum risk exposure level of no occupational exposure to welding fumes.

Study Appraisal And Synthesis Methods: At least two review authors will independently screen titles and abstracts against the eligibility criteria at a first stage and full texts of potentially eligible records at a second stage, followed by extraction of data from qualifying studies. Two or more review authors will assess risk of bias and the quality of evidence, using the Navigation Guide tool or approach. If feasible, we will combine relative risks using meta-analysis. We will report results using the preferred reporting items for systematic reviews and meta-analyses guidelines (PRISMA).
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http://dx.doi.org/10.1016/j.envint.2020.106089DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7569600PMC
December 2020

Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19:Serologic Testing.

Clin Infect Dis 2020 Sep 12. Epub 2020 Sep 12.

Division of Nephrology and Hypertension, Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.

Background: The availability of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serologic testing has rapidly increased. Current assays use a variety of technologies, measure different classes of immunoglobulin or immunoglobulin combinations and detect antibodies directed against different portions of the virus. The overall accuracy of these tests, however, has not been well-defined. The Infectious Diseases Society of America (IDSA) convened an expert panel to perform a systematic review of the coronavirus disease 2019 (COVID-19) serology literature and construct best practice guidance related to SARS-CoV-2 serologic testing. This guideline is the fourth in a series of rapid, frequently updated COVID-19 guidelines developed by IDSA.

Objective: IDSA's goal was to develop evidence-based recommendations that assist clinicians, clinical laboratories, patients and policymakers in decisions related to the optimal use of SARS-CoV-2 serologic tests in a variety of settings. We also highlight important unmet research needs pertaining to the use of anti-SARS-CoV-2 antibody tests for diagnosis, public health surveillance, vaccine development and the selection of convalescent plasma donors.

Methods: A multidisciplinary panel of infectious diseases clinicians, clinical microbiologists and experts in systematic literature review identified and prioritized clinical questions related to the use of SARS-CoV-2 serologic tests. Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology was used to assess the certainty of evidence and make testing recommendations.

Results: The panel agreed on eight diagnostic recommendations.

Conclusions: Information on the clinical performance and utility of SARS-CoV-2 serologic tests are rapidly emerging. Based on available evidence, detection of anti-SARS-CoV-2 antibodies may be useful for confirming the presence of current or past infection in selected situations. The panel identified three potential indications for serologic testing including: 1) evaluation of patients with a high clinical suspicion for COVID-19 when molecular diagnostic testing is negative and at least two weeks have passed since symptom onset; 2) assessment of multisystem inflammatory syndrome in children; and 3) for conducting serosurveillance studies. The certainty of available evidence supporting the use of serology for either diagnosis or epidemiology was, however, graded as very low to moderate.
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http://dx.doi.org/10.1093/cid/ciaa1343DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7543294PMC
September 2020

ONS Guidelines™ for Cancer Treatment-Related Skin Toxicity.

Oncol Nurs Forum 2020 09;47(5):539-556

McMaster University.

Background: Management of cancer treatment-related skin toxicities can minimize treatment disruptions and improve patient well-being.

Objectives: This guideline aims to support patients and clinicians in decisions regarding management of cancer treatment-related skin toxicities.

Methods: A panel developed a guideline for management of cancer treatment-related skin toxicities using GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) for certainty of evidence and the National Academies of Sciences, Engineering, and Medicine criteria for trustworthy guidelines. The Cochrane risk-of-bias tool assessed risk of bias. A quantitative or narrative synthesis of the evidence was completed.

Results: The panel issued seven conditional recommendations for epidermal growth factor receptor inhibitor rash, hand-foot skin reaction, hand-foot syndrome, and chemotherapy-induced alopecia. The panel suggested strategies for prevention and treatment for all toxicities except hand-foot syndrome, which only has a prevention recommendation.

Implications For Nursing: Cancer treatment-related skin toxicities can significantly affect quality of life. Incorporation of these interventions into clinical care can improve patient outcomes.

Supplementary Material Can Be Found At https: //onf.ons.org/supplementary-material-ons-guidelines-cancer-treatment-related-skin-toxicity.
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http://dx.doi.org/10.1188/20.ONF.539-556DOI Listing
September 2020

Conservative Intervention Strategies for Adult Cancer-Related Lymphedema: A Systematic Review and Network Meta-Analysis.

Oncol Nurs Forum 2020 09;47(5):E171-E189

McMaster University.

Problem Identification: The comparative effectiveness of available management options for cancer-related secondary lymphedema is unknown.

Literature Search: CINAHL®, Embase®, and MEDLINE® were searched for randomized trials comparing conservative treatment strategies.

Data Evaluation: A network meta-analysis was conducted for lymphedema volume, along with pairwise meta-analyses for remaining outcomes. Evidence certainty was assessed using the GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) approach.

Synthesis: Overall, 36 studies with a total of 1,651 participants were included. Compared to standard care, conservative treatments did not significantly reduce lymphedema volume. There was low to very low certainty evidence of benefit for several treatments on secondary outcomes.

Implications For Practice: There is insufficient evidence to suggest important differences between standard care and conservative treatment strategies for reducing lymphedema volume and improving lymphedema-related symptoms.

Supplemental Material Can Be Found At https: //onf.ons.org/supplementary-material-conservative-intervention-strategies-adult-cancer-related-lymphedema.
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http://dx.doi.org/10.1188/20.ONF.E171-E189DOI Listing
September 2020

Targeted Therapy- and Chemotherapy-Associated Skin Toxicities: Systematic Review and Meta-Analysis.

Oncol Nurs Forum 2020 09;47(5):E149-E160

Mayo Clinic.

Problem Identification: Preventing and managing skin toxicities can minimize treatment disruptions and improve well-being. This systematic review aimed to evaluate the effectiveness of interventions for the prevention and management of cancer treatment-related skin toxicities.

Literature Search: The authors systematically searched for comparative studies published before April 1, 2019. Study selection and appraisal were conducted by pairs of independent reviewers.

Data Evaluation: The random-effects model was used to conduct meta-analysis when appropriate.

Synthesis: 39 studies (6,006 patients) were included; 16 of those provided data for meta-analysis. Prophylactic minocycline reduced the development of all-grade and grade 1 acneform rash in patients who received erlotinib. Prophylaxis with pyridoxine 400 mg in capecitabine-treated patients lowered the risk of grade 2 or 3 hand-foot syndrome. Several treatments for hand-foot skin reaction suggested benefit in heterogeneous studies. Scalp cooling significantly reduced the risk for severe hair loss or total alopecia associated with chemotherapy.

Implications For Research: Certainty in the available evidence was limited for several interventions, suggesting the need for future research.

Supplemental Material Can Be Found At https: //onf.ons.org/supplementary-material-targeted-therapy-and-chemotherapy-associated-skin-toxicity-systematic-review.
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http://dx.doi.org/10.1188/20.ONF.E149-E160DOI Listing
September 2020

Prospective Surveillance and Risk Reduction of Cancer Treatment-Related Lymphedema: Systematic Review and Meta-Analysis.

Oncol Nurs Forum 2020 09;47(5):E161-E170

Mayo Clinic.

Problem Identification: Secondary lymphedema is a chronic condition that may result from cancer-related treatments. Evidence is emerging on prospective surveillance and risk reduction.

Literature Search: Databases were systematically searched through April 1, 2019, for comparative studies evaluating interventions aiming to prevent lymphedema in patients with cancer.

Data Evaluation: A random-effects model was used to perform meta-analysis, when appropriate.

Synthesis: A total of 26 studies (4,095 patients) were included, with 23 providing data sufficient for meta-analysis. Surveillance programs increased the likelihood of detecting lymphedema. Physiotherapy, exercise programs, and delayed exercise reduced the incidence of lymphedema.

Implications For Research: Future research should standardize (a) evidence-based interventions to reduce the development of lymphedema and increase the likelihood of early detection and (b) outcome measures to build a body of evidence that leads to practice change.

Supplemental Material Can Be Found At https: //onf.ons.org/supplementary-material-systematic-review-cancer-treatment-related-lymphedema.
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http://dx.doi.org/10.1188/20.ONF.E161-E170DOI Listing
September 2020

ONS Guidelines™ for Cancer Treatment-Related Lymphedema.

Oncol Nurs Forum 2020 09;47(5):518-538

McMaster University.

Purpose: Lymphedema is a chronic condition that may result from cancer-related surgery. The incidence of lymphedema varies greatly; however, patients remain at risk for life and may experience decreased quality of life and functional capacity. Providing recommendations for an evidence-based guideline for care of cancer treatment-related lymphedema will help to improve outcomes for patients with this chronic condition.

Methodologic Approach: A panel of healthcare professionals with patient representation convened to develop a national clinical practice guideline on prospective surveillance, risk reduction, and conservative treatment of lymphedema. Systematic reviews of the literature were conducted and the GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) methodology approach was used to assess the evidence.

Findings: The panel made multiple recommendations for patients who are at risk for or experiencing lymphedema.

Implications For Nursing: Early diagnosis and treatment of lymphedema may mitigate symptoms. This evidence-based guideline supports patients, clinicians, and other healthcare professionals in clinical decision making.

Supplementary Material Can Be Found At https: //onf.ons.org/supplementary-material-ons-guidelines-cancer-treatment-related-lymphedema.
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http://dx.doi.org/10.1188/20.ONF.518-538DOI Listing
September 2020

Management of Acute Pain From Non-Low Back, Musculoskeletal Injuries : A Systematic Review and Network Meta-analysis of Randomized Trials.

Ann Intern Med 2020 11 18;173(9):730-738. Epub 2020 Aug 18.

McMaster University, Hamilton, Ontario, Canada (B.S., Y.O., E.C., S.A.R., P.E., S.T.N., W.Y., A.L., S.H.A., S.C., R.C., R.L.M., K.A., A.P., Y.S., A.D., G.H.G.).

Background: Patients and clinicians can choose from several treatment options to address acute pain from non-low back, musculoskeletal injuries.

Purpose: To assess the comparative effectiveness of outpatient treatments for acute pain from non-low back, musculoskeletal injuries by performing a network meta-analysis of randomized clinical trials (RCTs).

Data Sources: MEDLINE, EMBASE, CINAHL, PEDro (Physiotherapy Evidence Database), and Cochrane Central Register of Controlled Trials to 2 January 2020.

Study Selection: Pairs of reviewers independently identified interventional RCTs that enrolled patients presenting with pain of up to 4 weeks' duration from non-low back, musculoskeletal injuries.

Data Extraction: Pairs of reviewers independently extracted data. Certainty of evidence was evaluated by using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach.

Data Synthesis: The 207 eligible studies included 32 959 participants and evaluated 45 therapies. Ninety-nine trials (48%) enrolled populations with diverse musculoskeletal injuries, 59 (29%) included patients with sprains, 13 (6%) with whiplash, and 11 (5%) with muscle strains; the remaining trials included various injuries ranging from nonsurgical fractures to contusions. Topical nonsteroidal anti-inflammatory agents (NSAIDs) proved to have the greatest net benefit, followed by oral NSAIDs and acetaminophen with or without diclofenac. Effects of these agents on pain were modest (around 1 cm on a 10-cm visual analogue scale, approximating the minimal important difference). Regarding opioids, compared with placebo, acetaminophen plus an opioid improved intermediate pain (1 to 7 days) but not immediate pain (≤2 hours), tramadol was ineffective, and opioids increased the risk for gastrointestinal and neurologic harms (all moderate-certainty evidence).

Limitations: Only English-language studies were included. The number of head-to-head comparisons was limited.

Conclusion: Topical NSAIDs, followed by oral NSAIDs and acetaminophen with or without diclofenac, showed the most convincing and attractive benefit-harm ratio for patients with acute pain from non-low back, musculoskeletal injuries. No opioid achieved benefit greater than that of NSAIDs, and opioids caused the most harms.

Primary Funding Source: National Safety Council. (PROSPERO: CRD42018094412).
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http://dx.doi.org/10.7326/M19-3601DOI Listing
November 2020

Spotlight: Probiotics Guidelines.

Gastroenterology 2020 08 22;159(2):707. Epub 2020 Jul 22.

Section of Gastroenterology, Hepatology & Nutrition, Department of Pediatrics, Baylor College of, Medicine and Texas Children's Hospital, Houston, TX.

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http://dx.doi.org/10.1053/j.gastro.2020.07.025DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8046260PMC
August 2020