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"Saldanha, Ian J."
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How should systematic reviewers handle conference abstracts? A view from the trenches
2019
Background
While identifying and cataloging unpublished studies from conference proceedings is generally recognized as a good practice during systematic reviews, controversy remains whether to include study results that are reported in conference abstracts. Existing guidelines provide conflicting recommendations.
Main body
The main argument for including conference abstracts in systematic reviews is that abstracts with positive results are preferentially published, and published sooner, as full-length articles compared with other abstracts. Arguments against including conference abstracts are that (1) searching for abstracts is resource-intensive, (2) abstracts may not contain adequate information, and (3) the information in abstracts may not be dependable. However, studies comparing conference abstracts and fully published articles of the same study find only minor differences, usually with conference abstracts presenting preliminary results. Other studies that have examined differences in treatment estimates of meta-analyses with and without conference abstracts report changes in precision, but usually not in the treatment effect estimate. However, in some cases, including conference abstracts has made a difference in the estimate of the treatment effect, not just its precision. Instead of arbitrarily deciding to include or exclude conference abstracts in systematic reviews, we suggest that systematic reviewers should consider the availability of evidence informing the review. If available evidence is sparse or conflicting, it may be worthwhile to search for conference abstracts. Further, attempts to contact authors of abstracts or search for protocols or trial registers to supplement the information presented in conference abstracts is prudent. If unique information from conference abstracts is included in a meta-analysis, a sensitivity analysis with and without the unique results should be conducted.
Conclusions
Under given circumstances, it is worthwhile to search for and include results from conference abstracts in systematic reviews.
Journal Article
Review finds core outcome set uptake in new studies and systematic reviews needs improvement
by
Tunis, Sean
,
Saldanha, Ian J.
,
Barrington, Heather
in
Clinical trials
,
Core outcome set
,
Coronaviruses
2022
To review evidence about the uptake of core outcome sets (COS). A COS is an agreed standardized set of outcomes that should be measured and reported, as a minimum, in all clinical trials in a specific area of health or healthcare.
This article provides an analysis of what is known about the uptake of COS in research. Similarities between COS and outcomes recommended by stakeholders in the evidence ecosystem is reviewed and actions taken by them to facilitate COS uptake described.
COS uptake is low in most research areas. Common facilitators relate to trialist awareness and understanding. Common barriers were not including in the development process all specialties that might use the COS and the lack of recommendations for how to measure the outcomes. Increasingly, COS developers are considering strategies for promoting uptake earlier in the process, including actions beyond traditional dissemination approaches. An overlap between COS and outcomes in regulatory documents and health technology assessments is good. An increasing number and variety of organizations are recommending COS be considered.
We suggest actions for various stakeholders for improving COS uptake. Research is needed to assess the impact of these actions to identify effective evidence-based strategies.
Journal Article
Evaluating the quality of evidence for gaming disorder: A summary of systematic reviews of associations between gaming disorder and depression or anxiety
2020
Gaming disorder has been described as an urgent public health problem and has garnered many systematic reviews of its associations with other health conditions. However, review methodology can contribute to bias in the conclusions, leading to research, policy, and patient care that are not truly evidence-based. This study followed a pre-registered protocol (PROSPERO 2018 CRD42018090651) with the objective of identifying reliable and methodologically-rigorous systematic reviews that examine the associations between gaming disorder and depression or anxiety in any population. We searched PubMed and PsycInfo for published systematic reviews and the gray literature for unpublished systematic reviews as of June 24, 2020. Reviews were classified as reliable according to several quality criteria, such as whether they conducted a risk of bias assessment of studies and whether they clearly described how outcomes from each study were selected. We assessed possible selective outcome reporting among the reviews. Seven reviews that included a total of 196 studies met inclusion criteria. The overall number of participants was not calculable because not all reviews reported these data. All reviews specified eligibility criteria for studies, but not for outcomes within studies. Only one review assessed risk of bias. Evidence of selective outcome reporting was found in all reviews-only one review incorporated any of the null findings from studies it included. Thus, none were classified as reliable according to prespecified quality criteria. Systematic reviews related to gaming disorder do not meet methodological standards. As clinical and policy decisions are heavily reliant on reliable, accurate, and unbiased evidence synthesis; researchers, clinicians, and policymakers should consider the implications of selective outcome reporting. Limitations of the current summary include using counts of associations and restricting to systematic reviews published in English. Systematic reviewers should follow established guidelines for review conduct and transparent reporting to ensure evidence about technology use disorders is reliable.
Journal Article
Oropharyngeal cancer risk groups in the United States: a meta-analysis and SEER analysis
by
Saldanha, Ian J.
,
Bandala-Jacques, Antonio
,
D’Souza, Gypsyamber
in
African Americans
,
Aged
,
Anal cancer
2025
Background
Incidence of oropharyngeal cancer (OPC) in the United States (US) has increased significantly due to human papillomavirus infections. This study characterized OPC incidence rates (IRs) by subgroups to identify high-risk populations for future screening efforts.
Methods
We conducted a comprehensive analysis comprising a systematic review and meta-analysis of studies published since 2000 reporting OPC IRs in the US, supplemented by a primary analysis of data from the Surveillance, Epidemiology, and End Results (SEER) program. From each source, we extracted cases and person-years to calculate IRs per 100,000 person-years (PY). Data from 11 studies selected for meta-analysis were analyzed using random-effects models. We stratified analyses by sex, age, race/ethnicity, and HIV status, as available.
Results
The meta-analysis found an overall OPC IR of 8.2 per 100,000 PY. Men had four times the incidence of OPC than women (13.4 and 3.6 per 100,000 PY, respectively). People living with HIV (PLWH) had the highest IR (27.6 per 100,000 PY), particularly men LWH (35.2 per 100,000 PY, compared to 12.4 in women LWH). SEER data confirmed sex differences, with low incidence in men < 50 years and in women of all ages, and a peak IR among men 60–79 years (32.4 per 100,000 PY). Among men aged 60–79, IRs were higher among White, Black, and American Indian/Alaskan Native (25.7–39.6 per 100,000 PY) than Hispanic/Latino or Asian American/Pacific Islander men (8.8–16.7 per 100,000 PY).
Conclusions
Men aged 50–79 years and PLWH are at highest risk for OPC, with IRs comparable with or exceeding those of other HPV-associated cancers in the US. Any future screening efforts should prioritize these groups while excluding low-risk populations, such as women and individuals < 50 years.
Registration:
PROSPERO CRD42024588671.
Journal Article
Outcomes in Cochrane Systematic Reviews Addressing Four Common Eye Conditions: An Evaluation of Completeness and Comparability
2014
Choice of outcomes is critical for clinical trialists and systematic reviewers. It is currently unclear how systematic reviewers choose and pre-specify outcomes for systematic reviews. Our objective was to assess the completeness of pre-specification and comparability of outcomes in all Cochrane reviews addressing four common eye conditions.
We examined protocols for all Cochrane reviews as of June 2013 that addressed glaucoma, cataract, age-related macular degeneration (AMD), and diabetic retinopathy (DR). We assessed completeness and comparability for each outcome that was named in ≥ 25% of protocols on those topics. We defined a completely-specified outcome as including information about five elements: domain, specific measurement, specific metric, method of aggregation, and time-points. For each domain, we assessed comparability in how individual elements were specified across protocols.
We identified 57 protocols addressing glaucoma (22), cataract (16), AMD (15), and DR (4). We assessed completeness and comparability for five outcome domains: quality-of-life, visual acuity, intraocular pressure, disease progression, and contrast sensitivity. Overall, these five outcome domains appeared 145 times (instances). Only 15/145 instances (10.3%) were completely specified (all five elements) (median = three elements per outcome). Primary outcomes were more completely specified than non-primary (median = four versus two elements). Quality-of-life was least completely specified (median = one element). Due to largely incomplete outcome pre-specification, conclusive assessment of comparability in outcome usage across the various protocols per condition was not possible.
Outcome pre-specification was largely incomplete; we encourage systematic reviewers to consider all five elements. This will indicate the importance of complete specification to clinical trialists, on whose work systematic reviewers depend, and will indirectly encourage comparable outcome choice to reviewers undertaking related research questions. Complete pre-specification could improve efficiency and reduce bias in data abstraction and analysis during a systematic review. Ultimately, more completely specified and comparable outcomes could make systematic reviews more useful to decision-makers.
Journal Article
Use of core outcome sets was low in clinical trials published in major medical journals
by
Gorst, Sarah L
,
Dodd, Susanna
,
Young, Amber E
in
Clinical trials
,
Cohort Studies
,
Core outcome sets
2022
To examine current practices in late-phase trials published in major medical journals and examine trialists’ views about core outcome set (COS) use.
A sequential multi-methods study was conducted. We examined late-phase trials published between October 2019 and March 2020 in JAMA, NEJM, The Lancet, BMJ, and Annals of Internal Medicine. The COMET database was searched for COS potentially relevant to trials not reporting using a COS; overlap of trial and COS outcomes was examined. An online survey examined awareness of, and decisions to search for and use a COS.
Ninety-five trials were examined; 93 (98%) did not report using a COS. Relevant COS were identified for 31 trials (33%). Core outcomes were measured in 9 (23%) studies; all trials measured at least one core outcome. Thirty-one trialists (33%) completed our survey. The most common barrier to COS use was trialist's own outcome preferences and choice (68%). The most common perceived facilitator was awareness and knowledge about COS (90%).
COS use in this cohort of trials was low, even when relevant COS were available. Increased use of COS in clinical trials can improve evaluation of intervention effects and evidence synthesis and reduce research waste.
Journal Article
Development and validation of a predictive model for critical illness in adult patients requiring hospitalization for COVID-19
2021
Identifying factors that can predict severe disease in patients needing hospitalization for COVID-19 is crucial for early recognition of patients at greatest risk.
(1) Identify factors predicting intensive care unit (ICU) transfer and (2) develop a simple calculator for clinicians managing patients hospitalized with COVID-19.
A total of 2,685 patients with laboratory-confirmed COVID-19 admitted to a large metropolitan health system in Georgia, USA between March and July 2020 were included in the study. Seventy-five percent of patients were included in the training dataset (admitted March 1 to July 10). Through multivariable logistic regression, we developed a prediction model (probability score) for ICU transfer. Then, we validated the model by estimating its performance accuracy (area under the curve [AUC]) using data from the remaining 25% of patients (admitted July 11 to July 31).
We included 2,014 and 671 patients in the training and validation datasets, respectively. Diabetes mellitus, coronary artery disease, chronic kidney disease, serum C-reactive protein, and serum lactate dehydrogenase were identified as significant risk factors for ICU transfer, and a prediction model was developed. The AUC was 0.752 for the training dataset and 0.769 for the validation dataset. We developed a free, web-based calculator to facilitate use of the prediction model (https://icucovid19.shinyapps.io/ICUCOVID19/).
Our validated, simple, and accessible prediction model and web-based calculator for ICU transfer may be useful in assisting healthcare providers in identifying hospitalized patients with COVID-19 who are at high risk for clinical deterioration. Triage of such patients for early aggressive treatment can impact clinical outcomes for this potentially deadly disease.
Journal Article
Study found increasing use of core outcome sets in Cochrane systematic reviews and identified facilitators and barriers
by
Kirkham, Jamie J.
,
Lucas, Samuel W.
,
Saldanha, Ian J.
in
Barriers
,
Clinical outcomes
,
Core outcome sets
2024
In 2019, only 7% of Cochrane systematic reviews (SRs) cited a core outcome set (COS) in relation to choosing outcomes, even though a relevant COS existed but was not mentioned (or cited) for a further 29% of SRs. Our objectives for the current work were to (1) examine the extent to which authors are currently considering COS to inform outcome choice in Cochrane protocols and completed SRs, and (2) understand author facilitators and barriers to using COS.
We examined all completed Cochrane SRs published in the last 3 months of 2022 and all Cochrane protocols published in 2022 for the extent to which they: (a) cited a COS, (b) searched for COS, (c) used outcomes from existing COS, and (d) reported outcome inconsistency among included studies and/or noted the need for COS. One investigator extracted information; a second extractor verified all information, discussing discrepancies to achieve consensus. We then conducted an online survey of authors of the included SRs to assess awareness of COS and identify facilitators and barriers to using COS to inform outcome choice.
Objective 1: We included 294 SRs of interventions (84 completed SRs and 210 published SR protocols), of which 13% cited specific COS and 5% did not cite but mentioned searching for COS. A median of 83% of core outcomes from cited COS (interquartile range [IQR] 57%–100%) were included in the corresponding SR. We identified a relevant COS for 39% of SRs that did not cite a COS. A median of 50% of core outcomes from noncited COS (IQR 35%–72%) were included in the corresponding SR. Objective 2: Authors of 236 (80%) of the 294 eligible SRs completed our survey. Seventy-seven percent of authors noted being aware of COS before the survey. Fifty-five percent of authors who did not cite COS but were aware of them reported searching for a COS. The most reported facilitators of using COS were author awareness of the existence of COS (59%), author positive perceptions of COS (52%), and recommendation in the Cochrane Handbook regarding COS use (48%). The most reported barriers related to matching of the scope of the COS and the SR: the COS target population was too narrow/broad relative to the SR population (29%) or the COS target intervention was too narrow/broad relative to the SR intervention (21%). Most authors (87%) mentioned that they would consider incorporating missing core outcomes in the SR/update.
Since 2019, there is increasing consideration and awareness of COS when choosing outcomes for Cochrane SRs of interventions, but uptake remains low and can be improved further. Use of COS in SRs is important to improve outcome standardization, reduce research waste, and improve evidence syntheses of the relevant effects of interventions across health research.
Journal Article
Assessing the relevance and uptake of core outcome sets (an agreed minimum collection of outcomes to measure in research studies) in Cochrane systematic reviews: a review
by
Gorst, Sarah L
,
Hughes, Karen
,
Schmitt, Jochen
in
Clinical decision making
,
Clinical trials
,
Decision making
2020
ObjectivesA core outcome set (COS) is an agreed standardised minimum collection of outcomes that should be measured and reported in research in a specific area of health. Cochrane systematic reviews (‘reviews’) are rigorous reviews on health-related topics conducted under the auspices of Cochrane. This study examines the use of existing COS to inform the choice of outcomes in Cochrane systematic reviews (‘reviews’) and investigates the views of the coordinating editors of Cochrane Review Groups (CRGs) on this topic.MethodsA cohort of 100 recently published or updated Cochrane reviews were assessed for reference to a COS being used to inform the choice of outcomes for the review. Existing COS, published 2 or more years before the review publication, were then identified to assess how often a reviewer could have used a relevant COS if it was available. We asked 52 CRG coordinating editors about their involvement in COS development, how outcomes are selected for reviews in their CRG and their views of the advantages and challenges surrounding the standardisation of outcomes within their CRG.ResultsIn the cohort of reviews from 2019, 40% (40/100) of reviewers noted problems due to outcome inconsistency across the included studies. In 7% (7/100) of reviews, a COS was referenced in relation to the choice of outcomes for the review. Relevant existing COS could be considered for a review update in 35% of the others (33/93). Most editors who responded (31/36, 86%) thought that COS should definitely or possibly be used to inform the choice of outcomes in a review.ConclusionsSystematic reviewers are continuing to note outcome heterogeneity but are starting to use COS to inform their reviews. There is potential for greater uptake of COS in Cochrane reviews.
Journal Article
Outcome choice and definition in systematic reviews leads to few eligible studies included in meta-analyses: a case study
by
Saldanha, Ian J.
,
Dickersin, Kay
,
Lindsley, Kristina B.
in
Algorithms
,
Anxiety
,
Clinical decision making
2020
Background
There is broad recognition of the importance of evidence in informing clinical decisions. When information from all studies included in a systematic review (“review”) does not contribute to a meta-analysis, decision-makers can be frustrated. Our objectives were to use the field of eyes and vision as a case study and examine the extent to which authors of Cochrane reviews conducted meta-analyses for their review’s pre-specified main outcome domain and the reasons that some otherwise eligible studies were not incorporated into meta-analyses.
Methods
We examined all completed systematic reviews published by Cochrane Eyes and Vision, as of August 11, 2017. We extracted information about each review’s outcomes and, using an algorithm, categorized one outcome as its “main” outcome. We calculated the percentage of included studies incorporated into meta-analyses for any outcome and for the main outcome. We examined reasons for non-inclusion of studies into the meta-analysis for the main outcome.
Results
We identified 175 completed reviews, of which 125 reviews included two or more studies. Across these 125 reviews, the median proportions of studies incorporated into at least one meta-analysis for any outcome and for the main outcome were 74% (interquartile range [IQR] 0–100%) and 28% (IQR 0–71%), respectively. Fifty-one reviews (41%) could not conduct a meta-analysis for the main outcome, mostly because fewer than two included studies measured the outcome (21/51 reviews) or the specific measurements for the outcome were inconsistent (16/51 reviews).
Conclusions
Outcome choice during systematic reviews can lead to few eligible studies included in meta-analyses. Core outcome sets and improved reporting of outcomes can help solve some of these problems.
Journal Article