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Article ; Online: Validity of observational evidence on putative risk and protective factors

Perrine Janiaud / Arnav Agarwal / Ioanna Tzoulaki / Evropi Theodoratou / Konstantinos K. Tsilidis / Evangelos Evangelou / John P. A. Ioannidis

BMC Medicine, Vol 19, Iss 1, Pp 1-

appraisal of 3744 meta-analyses on 57 topics

2021 Volume 17

Abstract: Abstract Background The validity of observational studies and their meta-analyses is contested. Here, we aimed to appraise thousands of meta-analyses of observational studies using a pre-specified set of quantitative criteria that assess the significance, ...

Abstract	Abstract Background The validity of observational studies and their meta-analyses is contested. Here, we aimed to appraise thousands of meta-analyses of observational studies using a pre-specified set of quantitative criteria that assess the significance, amount, consistency, and bias of the evidence. We also aimed to compare results from meta-analyses of observational studies against meta-analyses of randomized controlled trials (RCTs) and Mendelian randomization (MR) studies. Methods We retrieved from PubMed (last update, November 19, 2020) umbrella reviews including meta-analyses of observational studies assessing putative risk or protective factors, regardless of the nature of the exposure and health outcome. We extracted information on 7 quantitative criteria that reflect the level of statistical support, the amount of data, the consistency across different studies, and hints pointing to potential bias. These criteria were level of statistical significance (pre-categorized according to 10−6, 0.001, and 0.05 p-value thresholds), sample size, statistical significance for the largest study, 95% prediction intervals, between-study heterogeneity, and the results of tests for small study effects and for excess significance. Results 3744 associations (in 57 umbrella reviews) assessed by a median number of 7 (interquartile range 4 to 11) observational studies were eligible. Most associations were statistically significant at P < 0.05 (61.1%, 2289/3744). Only 2.6% of associations had P < 10−6, ≥1000 cases (or ≥20,000 participants for continuous factors), P < 0.05 in the largest study, 95% prediction interval excluding the null, and no large between-study heterogeneity, small study effects, or excess significance. Across the 57 topics, large heterogeneity was observed in the proportion of associations fulfilling various quantitative criteria. The quantitative criteria were mostly independent from one another. Across 62 associations assessed in both RCTs and in observational studies, 37.1% had effect ...
Keywords	Umbrella review ; Observation studies ; Randomized clinical trials ; Mendelian randomization ; Medicine ; R
Subject code	310
Language	English
Publishing date	2021-07-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Treatment of critical bleeding events in patients with immune thrombocytopenia

Systematic Reviews, Vol 13, Iss 1, Pp 1-

a protocol for a systematic review and meta-analysis

2024 Volume 6

Abstract: Abstract Background Critical bleeding events in adults and children with ITP are medical emergencies; however, evidence-based treatment protocols are lacking. Due to the severe thrombocytopenia, (typically platelet count less than 20 × 109/L), a critical ...

Abstract	Abstract Background Critical bleeding events in adults and children with ITP are medical emergencies; however, evidence-based treatment protocols are lacking. Due to the severe thrombocytopenia, (typically platelet count less than 20 × 109/L), a critical bleed portends a high risk of death or disability. We plan to perform a systematic review and meta-analysis of treatments for critical bleeding in patients with ITP that will inform evidence-based recommendations. Methods Literature searches will be conducted in four electronic databases: Ovid MEDLINE, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), and PubMed. Eligible studies will be randomized controlled trials or observational studies that enrolled patients with ITP describing one or more interventions for the management of critical bleeding. Title and abstract screening, full-text screening, data extraction, and risk of bias evaluation will be conducted independently and in duplicate using Covidence and Excel. Outcomes will be pooled for meta-analysis where appropriate or summarized descriptively. Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology will be used to evaluate the certainty of the evidence. Primary outcomes of interest will include frequency of critical bleeds, mortality and bleeding-related mortality, bleeding resolution, platelet count, and disability. Discussion Evidence-based treatments for critical bleeding in patients with ITP are needed to improve patient outcomes and standardize care in the emergency setting. Systematic review registration CRD42020161206.
Keywords	Immune thrombocytopenia ; Thrombocytopenia ; Emergency management ; Critical bleeding ; Medicine ; R
Subject code	610
Language	English
Publishing date	2024-01-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Less intensive antileukemic therapies (monotherapy and/or combination) for older adults with acute myeloid leukemia who are not candidates for intensive antileukemic therapy

Luis Enrique Colunga-Lozano / Fernando Kenji Nampo / Arnav Agarwal / Pinkal Desai / Mark Litzow / Mikkael A Sekeres / Gordon H Guyatt / Romina Brignardello-Petersen

PLoS ONE, Vol 17, Iss 2, p e

A systematic review and meta-analysis.

2022 Volume 0263240

Abstract: Introduction Elderly patients with acute myeloid leukemia not eligible for intensive antileukemic therapy are treated with less intensive therapies, uncertainty remains regarding their relative merits. Objectives To compare the effectiveness and safety ... ...

Abstract	Introduction Elderly patients with acute myeloid leukemia not eligible for intensive antileukemic therapy are treated with less intensive therapies, uncertainty remains regarding their relative merits. Objectives To compare the effectiveness and safety of less intensive antileukemic therapies for older adults with newly diagnosed AML not candidates for intensive therapies. Methods We included randomized controlled trials (RCTs) and non-randomized studies (NRS) comparing less intensive therapies in adults over 55 years with newly diagnosed AML. We searched MEDLINE and EMBASE from inception to August 2021. We assessed risk of bias of RCTs with a modified Cochrane Risk of Bias tool, and NRS with the Non-Randomized Studies of Interventions tool (ROBINS-I). We calculated pooled hazard ratios (HRs), risk ratios (RRs), mean differences (MD) and their 95% confidence intervals (CIs) using a random-effects pairwise meta-analyses and assessed the certainty of evidence using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. Results We included 27 studies (17 RCTs, 10 NRS; n = 5,698), which reported 9 comparisons. Patients were treated with azacitidine, decitabine, and low-dose cytarabine (LDAC), as monotherapies or in combination with other agents. Moderate certainty of evidence suggests no convincing difference in overall survival of patients who receive azacitidine monotherapy compared to LDAC monotherapy (HR 0.69; 95% CI, 0.31-1.53), fewer febrile neutropenia events occurred between azacitidine monotherapy to azacitidine combination (RR 0.45; 95% CI, 0.31-0.65), and, fewer neutropenia events occurred between LDAC monotherapy to decitabine monotherapy (RR 0.62; 95% CI 0.44-0.86). All other comparisons and outcomes had low or very low certainty of evidence. Conclusion There is no convincing superiority in OS when comparing less intensive therapies. Azacitidine monotherapy is likely to have fewer adverse events than azacitidine combination (febrile neutropenia), and LDAC monotherapy is ...
Keywords	Medicine ; R ; Science ; Q
Subject code	610
Language	English
Publishing date	2022-01-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Shorter versus longer durations of antibiotic treatment for patients with community-acquired pneumonia

Gordon Guyatt / Arnav Agarwal / Mark Loeb / John Basmaji / Ya Gao / Maryam Ghadimi / Layla Bakaa / Luis Enrique Colunga Lozano / Saad Asif / Aninditee Das

BMJ Open, Vol 12, Iss

a protocol for a systematic review and meta-analysis

2022 Volume 6

Keywords	Medicine ; R
Language	English
Publishing date	2022-06-01T00:00:00Z
Publisher	BMJ Publishing Group
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Long-term and serious harms of medical cannabis and cannabinoids for chronic pain

Arnav Agarwal / Jason W Busse / Rachel Couban / Patrick Hong / Dena Zeraatkar / Thomas Agoritsas / Robin W M Vernooij / Brian Y Hong / Muhammad Muneeb Ahmed / Jared E Dookie / Matthew Adam Cooper / Gareth Leung / Kevin Loniewski / Chris Hong

BMJ Open, Vol 12, Iss

a systematic review of non-randomised studies

2022 Volume 8

Abstract: Objective To establish the prevalence of long-term and serious harms of medical cannabis for chronic pain.Design Systematic review and meta-analysis.Data sources MEDLINE, EMBASE, PsycINFO and CENTRAL from inception to 1 April 2020.Study selection Non- ... ...

Abstract	Objective To establish the prevalence of long-term and serious harms of medical cannabis for chronic pain.Design Systematic review and meta-analysis.Data sources MEDLINE, EMBASE, PsycINFO and CENTRAL from inception to 1 April 2020.Study selection Non-randomised studies reporting on harms of medical cannabis or cannabinoids in adults or children living with chronic pain with ≥4 weeks of follow-up.Data extraction and synthesis A parallel guideline panel provided input on the design and interpretation of the systematic review, including selection of adverse events for consideration. Two reviewers, working independently and in duplicate, screened the search results, extracted data and assessed risk of bias. We used random-effects models for all meta-analyses and the Grades of Recommendations, Assessment, Development and Evaluation approach to evaluate the certainty of evidence.Results We identified 39 eligible studies that enrolled 12 143 adult patients with chronic pain. Very low certainty evidence suggests that adverse events are common (prevalence: 26.0%; 95% CI 13.2% to 41.2%) among users of medical cannabis for chronic pain, particularly any psychiatric adverse events (prevalence: 13.5%; 95% CI 2.6% to 30.6%). Very low certainty evidence, however, indicates serious adverse events, adverse events leading to discontinuation, cognitive adverse events, accidents and injuries, and dependence and withdrawal syndrome are less common and each typically occur in fewer than 1 in 20 patients. We compared studies with <24 weeks and ≥24 weeks of cannabis use and found more adverse events reported among studies with longer follow-up (test for interaction p<0.01). Palmitoylethanolamide was usually associated with few to no adverse events. We found insufficient evidence addressing the harms of medical cannabis compared with other pain management options, such as opioids.Conclusions There is very low certainty evidence that adverse events are common among people living with chronic pain who use medical cannabis or ...
Keywords	Medicine ; R
Subject code	616
Language	English
Publishing date	2022-08-01T00:00:00Z
Publisher	BMJ Publishing Group
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Reporting of conflicts of interest by authors of primary studies on health policy and systems research

Gordon Guyatt / Arnav Agarwal / Elie A Akl / Assem M Khamis / Maram B Hakoum / Lama Bou-Karroum / Mounir Al-Gibbawi / Abdul Sattar Raslan / Sanaa Badour / Fadel Alturki / Fadi El-Jardali

BMJ Open, Vol 10, Iss

a cross-sectional survey

2020 Volume 7

Abstract: Objectives The objective of this study was to assess the frequency and types of conflict of interest (COI) disclosed by authors of primary studies of health policy and systems research (HPSR).Design We conducted a cross-sectional survey using standard ... ...

Abstract	Objectives The objective of this study was to assess the frequency and types of conflict of interest (COI) disclosed by authors of primary studies of health policy and systems research (HPSR).Design We conducted a cross-sectional survey using standard systematic review methodology for study selection and data extraction. We conducted descriptive analyses.Setting We collected data from papers published in 2016 in ‘health policy and service journals’ category in Web of Science database.Participants We included primary studies (eg, randomised controlled trials, cohort studies, qualitative studies) of HPSR published in English in 2016 peer-reviewed health policy and services journals.Outcome measures Reported COI disclosures including whether authors reported COI or not, form in which COI disclosures were provided, number of authors per paper who report any type of COI, number of authors per paper who report specific types and subtypes of COI.Results We included 200 eligible primary studies of which 132 (66%) included COI disclosure statements of authors. Of the 132 studies, 19 (14%) had at least one author reporting at least one type of COI and the most frequently reported type was individual financial COI (n=15, 11%). None of the authors reported individual intellectual COIs or personal COIs. Financial and individual COIs were reported more frequently compared with non-financial and institutional COIs.Conclusion A low percentage of HPSR primary studies included authors reporting COI. Non-financial or institutional COIs were the least reported types of COI.
Keywords	Medicine ; R
Subject code	001
Language	English
Publishing date	2020-07-01T00:00:00Z
Publisher	BMJ Publishing Group
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Non-COVID outcomes associated with the coronavirus disease-2019 (COVID-19) pandemic effects study (COPES)

Vincent Issac Lau / Sumeet Dhanoa / Harleen Cheema / Kimberley Lewis / Patrick Geeraert / David Lu / Benjamin Merrick / Aaron Vander Leek / Meghan Sebastianski / Brittany Kula / Dipayan Chaudhuri / Arnav Agarwal / Daniel J Niven / Kirsten M Fiest / Henry T Stelfox / Danny J Zuege / Oleksa G Rewa / Sean M Bagshaw

PLoS ONE, Vol 17, Iss 6, p e

A systematic review and meta-analysis.

2022 Volume 0269871

Abstract: Background As the Coronavirus Disease-2019 (COVID-19) pandemic continues, healthcare providers struggle to manage both COVID-19 and non-COVID patients while still providing high-quality care. We conducted a systematic review/meta-analysis to describe the ...

Abstract	Background As the Coronavirus Disease-2019 (COVID-19) pandemic continues, healthcare providers struggle to manage both COVID-19 and non-COVID patients while still providing high-quality care. We conducted a systematic review/meta-analysis to describe the effects of the COVID-19 pandemic on patients with non-COVID illness and on healthcare systems compared to non-pandemic epochs. Methods We searched Ovid MEDLINE/EMBASE/Cochrane Database of Systematic Reviews/CENTRAL/CINAHL (inception to December 31, 2020). All study types with COVID-pandemic time period (after December 31, 2019) with comparative non-pandemic time periods (prior to December 31, 2019). Data regarding study characteristics/case-mix/interventions/comparators/ outcomes (primary: mortality; secondary: morbidity/hospitalizations/disruptions-to-care. Paired reviewers conducted screening and abstraction, with conflicts resolved by discussion. Effect sizes for specific therapies were pooled using random-effects models. Risk of bias was assessed by Newcastle-Ottawa Scale, with evidence rating using GRADE methodology. Results Of 11,581 citations, 167 studies met eligibility. Our meta-analysis showed an increased mortality of 16% during the COVID pandemic for non-COVID illness compared with 11% mortality during the pre-pandemic period (RR 1.38, 95% CI: 1.28-1.50; absolute risk difference: 5% [95% CI: 4-6%], p<0.00001, very low certainty evidence). Twenty-eight studies (17%) reported significant changes in morbidity (where 93% reported increases), while 30 studies (18%) reported no significant change (very low certainty). Thirty-nine studies (23%) reported significant changes in hospitalizations (97% reporting decreases), while 111 studies (66%) reported no significant change (very low certainty). Sixty-two studies (37%) reported significant disruptions in standards-to-care (73% reporting increases), while 62 studies (37%) reported no significant change (very low certainty). Conclusions There was a significant increase in mortality during the COVID pandemic ...
Keywords	Medicine ; R ; Science ; Q
Subject code	310
Language	English
Publishing date	2022-01-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Ku-gaa-gii pimitizi-win, the COVID-19 cohort study of people experiencing homelessness in Toronto, Canada

BMJ Open, Vol 12, Iss

a study protocol

2022 Volume 8

Abstract: Introduction Initial reports suggest people experiencing homelessness (PEH) are at high risk for SARS-CoV-2 infection and associated morbidity and mortality. However, there have been few longitudinal evaluations of the spread and impact of COVID-19 among ...

Abstract	Introduction Initial reports suggest people experiencing homelessness (PEH) are at high risk for SARS-CoV-2 infection and associated morbidity and mortality. However, there have been few longitudinal evaluations of the spread and impact of COVID-19 among PEH. This study will estimate the prevalence and incidence of COVID-19 infections in a cohort of PEH followed prospectively in Toronto, Canada. It will also examine associations between individual-level and shelter-level characteristics with COVID-19 infection, adverse health outcomes related to infection and vaccination. Finally, the data will be used to develop and parameterise a mathematical model to characterise SARS-CoV-2 transmission dynamics, and the transmission impact of interventions serving PEH.Design, methods and analysis Ku-gaa-gii pimitizi-win will follow a random sample of PEH from across Toronto (Canada) for 12 months. 736 participants were enrolled between June and September 2021, and will be followed up at 3-month intervals. At each interval, specimens (saliva, capillary blood) will be collected to determine active SARS-CoV-2 infection and serologic evidence of past infection and/or vaccination, and a detailed survey will gather self-reported information, including a detailed housing history. To examine the association between individual-level and shelter-level characteristics on COVID-19-related infection, adverse outcomes, and vaccination, shelter and healthcare administrative data will be linked to participant study data. Healthcare administrative data will also be used to examine long-term (up to 5 years) COVID-19-related outcomes among participants.Ethics and dissemination Ethical approval was obtained from the Unity Health Toronto and University of Toronto Health Sciences Research Ethics Boards (# 20-272). Ku-gaa-gii pimitizi-win was designed in collaboration with community and service provider partners and people having lived experience of homelessness. Findings will be reported to groups supporting Ku-gaa-gii pimitizi-win, Indigenous ...
Keywords	Medicine ; R
Subject code	170 ; 360
Language	English
Publishing date	2022-08-01T00:00:00Z
Publisher	BMJ Publishing Group
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Prognostic factors for severity and mortality in patients infected with COVID-19

Ariel Izcovich / Martín Alberto Ragusa / Fernando Tortosa / María Andrea Lavena Marzio / Camila Agnoletti / Agustín Bengolea / Agustina Ceirano / Federico Espinosa / Ezequiel Saavedra / Verónica Sanguine / Alfredo Tassara / Candelaria Cid / Hugo Norberto Catalano / Arnav Agarwal / Farid Foroutan / Gabriel Rada

PLoS ONE, Vol 15, Iss 11, p e

A systematic review.

2020 Volume 0241955

Abstract: Background and purpose The objective of our systematic review is to identify prognostic factors that may be used in decision-making related to the care of patients infected with COVID-19. Data sources We conducted highly sensitive searches in PubMed/ ... ...

Abstract	Background and purpose The objective of our systematic review is to identify prognostic factors that may be used in decision-making related to the care of patients infected with COVID-19. Data sources We conducted highly sensitive searches in PubMed/MEDLINE, the Cochrane Central Register of Controlled Trials (CENTRAL) and Embase. The searches covered the period from the inception date of each database until April 28, 2020. No study design, publication status or language restriction were applied. Study selection and data extraction We included studies that assessed patients with confirmed or suspected SARS-CoV-2 infectious disease and examined one or more prognostic factors for mortality or disease severity. Reviewers working in pairs independently screened studies for eligibility, extracted data and assessed the risk of bias. We performed meta-analyses and used GRADE to assess the certainty of the evidence for each prognostic factor and outcome. Results We included 207 studies and found high or moderate certainty that the following 49 variables provide valuable prognostic information on mortality and/or severe disease in patients with COVID-19 infectious disease: Demographic factors (age, male sex, smoking), patient history factors (comorbidities, cerebrovascular disease, chronic obstructive pulmonary disease, chronic kidney disease, cardiovascular disease, cardiac arrhythmia, arterial hypertension, diabetes, dementia, cancer and dyslipidemia), physical examination factors (respiratory failure, low blood pressure, hypoxemia, tachycardia, dyspnea, anorexia, tachypnea, haemoptysis, abdominal pain, fatigue, fever and myalgia or arthralgia), laboratory factors (high blood procalcitonin, myocardial injury markers, high blood White Blood Cell count (WBC), high blood lactate, low blood platelet count, plasma creatinine increase, high blood D-dimer, high blood lactate dehydrogenase (LDH), high blood C-reactive protein (CRP), decrease in lymphocyte count, high blood aspartate aminotransferase (AST), decrease in blood ...
Keywords	Medicine ; R ; Science ; Q
Subject code	610 ; 630
Language	English
Publishing date	2020-01-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: The effect of a monetary incentive for administrative assistants on the survey response rate

Arnav Agarwal / Dany Raad / Victor Kairouz / John Fudyma / Anne B. Curtis / Holger J. Schünemann / Elie A. Akl

BMC Medical Research Methodology, Vol 16, Iss 1, Pp 1-

a randomized controlled trial

2016 Volume 5

Abstract: Abstract Background There is sufficient evidence that monetary incentives are effective in increasing survey response rates in the general population as well as with physicians. The objective of this study was to assess the impact of a monetary incentive ...

Abstract	Abstract Background There is sufficient evidence that monetary incentives are effective in increasing survey response rates in the general population as well as with physicians. The objective of this study was to assess the impact of a monetary incentive intended for administrative assistants on the survey response rate of physicians in leadership positions. Methods This was an ancillary study to a national survey of chairs of academic Departments of Medicine in the United States about measuring faculty productivity. We randomized survey participants to receive or not receive a $5 gift card enclosed in the survey package. The cover letter explained that the gift card was intended for the administrative assistants as a “thank you for their time.” We compared the response rates between the 2 study arms using the Chi-square test. Results Out of 152 participants to whom survey packages were mailed to, a total of 78 responses were received (51 % response rate). The response rates were 59 % in the incentive arm and 46 % in the no incentive arm. The relative effect of the incentive compared to no monetary incentive was borderline statistically significant (relative risk (RR) = 1.36, 95 % confidence interval (CI) 0.99 to 1.87; p = 0.055). Conclusion Monetary incentives intended for administrative assistants likely increase the response rate of physicians in leadership positions.
Keywords	Medicine (General) ; R5-920
Subject code	310
Language	English
Publishing date	2016-08-01T00:00:00Z
Publisher	BioMed Central
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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