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Article ; Online: Conducting separate reviews of benefits and harms could improve systematic reviews and meta-analyses.

Mayo-Wilson, Evan / Qureshi, Riaz / Li, Tianjing

2023 Volume 12, Issue 1, Page(s) 67

Abstract: Guidance for systematic reviews of interventions recommends both benefits and harms be included. Systematic reviews may reach conclusions about harms (or lack of harms) that are not true when reviews include only some relevant studies, rely on incomplete ...

Abstract	Guidance for systematic reviews of interventions recommends both benefits and harms be included. Systematic reviews may reach conclusions about harms (or lack of harms) that are not true when reviews include only some relevant studies, rely on incomplete data from eligible studies, use inappropriate methods for synthesizing data, and report results selectively. Separate reviews about harms could address some of these problems, and we argue that conducting separate reviews of harms is a feasible alternative to current standards and practices. Systematic reviews of potential benefits could be organized around the use of interventions for specific health problems. Systematic reviews of potential harms could be broader, including more diverse study designs and including all people at risk of harms (who might use the same intervention to treat different health problems). Multiple reviews about benefits could refer to a single review of harms. This approach could improve the reliability, completeness, and efficiency of systematic reviews.
MeSH term(s)	Humans ; Meta-Analysis as Topic ; Reproducibility of Results ; Research Design ; Research Report ; Systematic Reviews as Topic
Language	English
Publishing date	2023-04-15
Publishing country	England
Document type	Letter
ZDB-ID	2662257-9
ISSN	2046-4053 ; 2046-4053
ISSN (online)	2046-4053
ISSN	2046-4053
DOI	10.1186/s13643-023-02234-0
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Article ; Online: The SPIRIT Checklist-lessons from the experience of SPIRIT protocol editors.

Qureshi, Riaz / Gough, Alexander / Loudon, Kirsty

Trials

2022 Volume 23, Issue 1, Page(s) 359

Abstract: Crystal clear RCT protocols are of paramount importance. The reader needs to easily understand the trial methodology and know what is pre-planned. They need to know there are procedures in place if there are, for instance, protocol breaches and protocol ... ...

Abstract	Crystal clear RCT protocols are of paramount importance. The reader needs to easily understand the trial methodology and know what is pre-planned. They need to know there are procedures in place if there are, for instance, protocol breaches and protocol amendments are required, there is loss to follow-up and missing data, and how solicited and spontaneous reported adverse events are dealt with. This plan is important for the trial and for the results that will be published when the data is analysed. After all, individuals have consented to participate in these trials, and their time and their well-being matter. The Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) provides guidance to structure RCT protocols and ensures all essential information is included. But sadly, not all trialists follow the guidance, and sometimes, the information is misunderstood. Using experience peer-reviewing for Trials over the last 2 years, we have prepared information to assist authors, peer reviewers, editors, and other current and future SPIRIT protocol editors to use the SPIRIT guidance and understand its importance.
MeSH term(s)	Checklist ; Humans ; Publications
Language	English
Publishing date	2022-04-27
Publishing country	England
Document type	Letter
ZDB-ID	2040523-6
ISSN	1745-6215 ; 1468-6694 ; 1745-6215
ISSN (online)	1745-6215
ISSN	1468-6694 ; 1745-6215
DOI	10.1186/s13063-022-06316-7
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Article ; Online: Effectiveness of interventions for dry eye: a protocol for an overview of systematic reviews.

McCann, Paul / Kruoch, Zanna / Qureshi, Riaz / Li, Tianjing

BMJ open

2022 Volume 12, Issue 6, Page(s) e058708

Abstract: Introduction: Dry eye is a leading cause of ocular morbidity and economic and societal burden for patients and healthcare systems. There are several treatment options available for dry eye and high-quality systematic reviews synthesise the evidence for ... ...

Abstract	Introduction: Dry eye is a leading cause of ocular morbidity and economic and societal burden for patients and healthcare systems. There are several treatment options available for dry eye and high-quality systematic reviews synthesise the evidence for their effectiveness and potential harms. Methods and analysis: We will search the Cochrane Eyes and Vision US satellite (CEV@US) database of eyes and vision systematic reviews for systematic reviews on interventions for dry eye. CEV@US conducted an initial search of PubMed and Embase to populate the CEV@US database of eyes and vision systematic reviews in 2007, which was updated most recently in August 2021. We will search the database for systematic reviews published since 1 January 2016 because systematic reviews more than 5 years are unlikely to be up to date. We will consider Cochrane and non-Cochrane systematic reviews eligible for inclusion. Two authors will independently screen articles. We will include studies that evaluate interventions for dry eye and/or meibomian gland dysfunction with no restriction on types of participants or review language. We will select reliable systematic reviews (ie, those meeting pre-established methodological criteria) for inclusion, assessed by one investigator and verified by a second investigator. We will extract ratings of the certainty of evidence from within each review. We will report the degree of overlap for systematic reviews that answer similar questions and include overlapping primary studies. We will present results of the overview in alignment with guidelines in the Cochrane Handbook of Systematic Reviews of Interventions (Online Chapter 5: Overviews of Reviews), the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement, and an overview of reviews quality and transparency checklist. The anticipated start and completion dates for this overview are 1 May 2021 and 30 April 2022, respectively. Ethics and dissemination: This overview will not require the approval of an Ethics Committee because it will use published studies. We will publish results in a peer-reviewed journal. Prospero registration number: CRD42021279880.
MeSH term(s)	Databases, Factual ; Dry Eye Syndromes/etiology ; Dry Eye Syndromes/therapy ; Humans ; Research Design
Language	English
Publishing date	2022-06-07
Publishing country	England
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	2599832-8
ISSN	2044-6055 ; 2044-6055
ISSN (online)	2044-6055
ISSN	2044-6055
DOI	10.1136/bmjopen-2021-058708
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Article ; Online: Risk Factors for Vision Loss among Nursing Home Residents: A Cross-Sectional Analysis.

Monaco, William / Qureshi, Riaz / Arif, Areeb / Aggarwal, Sulbh / Meng, Hongdao

Journal of the American Medical Directors Association

2022 Volume 24, Issue 1, Page(s) 105–112.e1

Abstract: Objective: Approximately 2% of older adults currently live in nursing homes. It is important that the risks for vision loss be characterized to ensure appropriate vision care is provided for nursing home patients. Our objective was to evaluate the ... ...

Abstract	Objective: Approximately 2% of older adults currently live in nursing homes. It is important that the risks for vision loss be characterized to ensure appropriate vision care is provided for nursing home patients. Our objective was to evaluate the association of age-related eye diseases (AREDs) and multimorbidities with vision loss. Design: Cross-sectional study. Setting and participants: This is a cross-sectional analysis of comprehensive eye examination records for 7753 residents of 74 North Carolina nursing homes who were ≥65 years of age at time of the initial patient visit. Methods: Complete data on vision and associated factors were included from the standardized Centers for Medicare and Medicaid Services eye examination. We defined vision impairment and blindness respectively as best-corrected visual acuity between 20/40 and 20/200, and 20/200 or worse. Clinical diagnoses of AREDs were defined by the attending clinician. Data were extracted from electronic health records, and all analyses were conducted in SAS v 9.4. We used descriptive statistics to summarize the resident characteristics and AREDs and logistic regression analysis to examine independent risk factors for vision impairment. Results: A total of 7753 initial eye examination records with complete data were included in the analysis. Overall, 34% of the residents had normal vision, 43% had vision impairment, and 23% were blind. Among participants with various AREDs, the prevalence of vision impaired/blind ranged from 63% to 76%, while blindness ranged from 23% to 53%. We found correction of refractive error alone served to reduce vision impairment or blindness. Conclusions and implications: Comprehensive eye examinations showed vision impairment and blindness affected 66% of nursing home residents, overall. This study substantiates the positive impact of comprehensive eye examinations to promote visual, systemic, and cognitive health and well-being and the need that eye care service be used to inform policy and practice to improve patient functioning and independence.
MeSH term(s)	United States/epidemiology ; Humans ; Aged ; Cross-Sectional Studies ; Visual Acuity ; Medicare ; Vision Disorders/epidemiology ; Vision Disorders/complications ; Blindness/epidemiology ; Blindness/etiology ; Blindness/psychology ; Risk Factors ; Nursing Homes ; Prevalence
Language	English
Publishing date	2022-11-25
Publishing country	United States
Document type	Journal Article
ZDB-ID	2171030-2
ISSN	1538-9375 ; 1525-8610
ISSN (online)	1538-9375
ISSN	1525-8610
DOI	10.1016/j.jamda.2022.10.018
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Article ; Online: Predictors of citation count for systematic reviews in ophthalmology.

Lee, Matthew J / Lin, John C / Qureshi, Riaz / Greenberg, Paul B

Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie

2022 Volume 261, Issue 1, Page(s) 281–282

MeSH term(s)	Humans ; Ophthalmology ; Systematic Reviews as Topic ; Bibliometrics
Language	English
Publishing date	2022-08-09
Publishing country	Germany
Document type	Letter ; Comment
ZDB-ID	8435-9
ISSN	1435-702X ; 0721-832X
ISSN (online)	1435-702X
ISSN	0721-832X
DOI	10.1007/s00417-022-05790-8
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Article ; Online: Harms in Systematic Reviews Paper 1: An introduction to research on harms.

Qureshi, Riaz / Mayo-Wilson, Evan / Li, Tianjing

Journal of clinical epidemiology

2021 Volume 143, Page(s) 186–196

Abstract: Objective: Most systematic reviews of interventions focus on potential benefits. Common methods and assumptions that are appropriate for assessing benefits can be inappropriate for harms. This paper provides a primer on researching harms, particularly ... ...

Abstract	Objective: Most systematic reviews of interventions focus on potential benefits. Common methods and assumptions that are appropriate for assessing benefits can be inappropriate for harms. This paper provides a primer on researching harms, particularly in systematic reviews. Study design and setting: Commentary describing challenges with assessing harm. Results: Investigators should be familiar with various terminologies used to describe, classify, and group harms. Published reports of clinical trials include limited information about harms, so systematic reviewers should not depend on these studies and journal articles to reach conclusions about harms. Visualizations might improve communication of multiple dimensions of harms such as severity, relatedness, and timing. Conclusion: The terminology, classification, detection, collection, and reporting of harms create unique challenges that take time, expertise, and resources to navigate in both primary studies and evidence syntheses. Systematic reviewers might reach incorrect conclusions if they focus on evidence about harms found in published reports of randomized trials of a particular health problem. Systematic reviews could be improved through better identification and reporting of harms in primary studies and through better training and uptake of appropriate methods for synthesizing evidence about harms.
MeSH term(s)	Humans ; Research Personnel ; Research Report ; Systematic Reviews as Topic
Language	English
Publishing date	2021-11-03
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	639306-8
ISSN	1878-5921 ; 0895-4356
ISSN (online)	1878-5921
ISSN	0895-4356
DOI	10.1016/j.jclinepi.2021.10.023
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Article ; Online: Are ChatGPT and large language models "the answer" to bringing us closer to systematic review automation?

Qureshi, Riaz / Shaughnessy, Daniel / Gill, Kayden A R / Robinson, Karen A / Li, Tianjing / Agai, Eitan

Systematic reviews

2023 Volume 12, Issue 1, Page(s) 72

Abstract: In this commentary, we discuss ChatGPT and our perspectives on its utility to systematic reviews (SRs) through the appropriateness and applicability of its responses to SR related prompts. The advancement of artificial intelligence (AI)-assisted ... ...

Abstract	In this commentary, we discuss ChatGPT and our perspectives on its utility to systematic reviews (SRs) through the appropriateness and applicability of its responses to SR related prompts. The advancement of artificial intelligence (AI)-assisted technologies leave many wondering about the current capabilities, limitations, and opportunities for integration AI into scientific endeavors. Large language models (LLM)-such as ChatGPT, designed by OpenAI-have recently gained widespread attention with their ability to respond to various prompts in a natural-sounding way. Systematic reviews (SRs) utilize secondary data and often require many months and substantial financial resources to complete, making them attractive grounds for developing AI-assistive technologies. On February 6, 2023, PICO Portal developers hosted a webinar to explore ChatGPT's responses to tasks related to SR methodology. Our experience from exploring the responses of ChatGPT suggest that while ChatGPT and LLMs show some promise for aiding in SR-related tasks, the technology is in its infancy and needs much development for such applications. Furthermore, we advise that great caution should be taken by non-content experts in using these tools due to much of the output appearing, at a high level, to be valid, while much is erroneous and in need of active vetting.
MeSH term(s)	Humans ; Artificial Intelligence ; Automation ; Language ; Self-Help Devices ; Technology ; Systematic Reviews as Topic
Language	English
Publishing date	2023-04-29
Publishing country	England
Document type	Journal Article
ZDB-ID	2662257-9
ISSN	2046-4053 ; 2046-4053
ISSN (online)	2046-4053
ISSN	2046-4053
DOI	10.1186/s13643-023-02243-z
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Article ; Online: Interventions for Dry Eye: An Overview of Systematic Reviews.

McCann, Paul / Kruoch, Zanna / Lopez, Sarah / Malli, Shreya / Qureshi, Riaz / Li, Tianjing

JAMA ophthalmology

2023 Volume 142, Issue 1, Page(s) 58–74

Abstract: Importance: Dry eye is a common ocular disease that can have substantial morbidity. Systematic reviews provide evidence for dry eye interventions and can be useful for patients, clinicians, and clinical guideline developers. Overviews of reviews use ... ...

Abstract	Importance: Dry eye is a common ocular disease that can have substantial morbidity. Systematic reviews provide evidence for dry eye interventions and can be useful for patients, clinicians, and clinical guideline developers. Overviews of reviews use explicit and systematic methods to synthesize findings from multiple systematic reviews, but currently, there are no overviews of systematic reviews investigating interventions for dry eye. Objective: To summarize the results of reliable systematic reviews of dry eye interventions and to highlight the evidence gaps identified. Evidence review: We searched the Cochrane Eyes and Vision US satellite database and included reliable systematic reviews evaluating dry eye interventions published from 2016 to 2022. We reported the proportion of systematic reviews that were reliable with reasons for unreliability. Critical and important outcomes from reliable systematic reviews were extracted and verified. Critical outcomes included dry eye-related patient-reported outcome measures. Results were synthesized from reliable systematic reviews to provide summaries of evidence for each intervention. Evidence for each intervention was defined as conclusive or inconclusive depending on whether high-certainty evidence across systematic reviews was available according to Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) criteria and whether findings reached statistical or clinical significance. Recommendations were made for further research. Findings: Within the Cochrane Eyes and Vision US satellite database, 138 potentially relevant systematic reviews were identified, 71 were considered eligible, and 26 (37%) were assessed as reliable. Among reliable systematic reviews, no conclusive evidence was identified for any dry eye intervention. Inconclusive evidence suggested that environmental modifications, dietary modifications, artificial tears and lubricants, punctal occlusion, intense pulsed light therapy, vectored thermal pulsation therapy (Lipiflow), topical corticosteroids, topical cyclosporine A, topical secretagogues, and autologous serum may be effective. Only unreliable systematic reviews evaluated lifitegrast, oral antibiotics, and moisture chamber devices. Conclusions and relevance: This overview of systematic reviews found some evidence that dry eye interventions may be effective, but no conclusive evidence was available. The conduct and reporting of most systematic reviews for dry eye interventions warrant improvement, and reliable systematic reviews are needed to evaluate lifitegrast, oral antibiotics, and moisture chamber devices.
MeSH term(s)	Humans ; Systematic Reviews as Topic ; Dry Eye Syndromes/diagnosis ; Dry Eye Syndromes/therapy ; Sulfones ; Anti-Bacterial Agents/therapeutic use ; Phenylalanine/analogs & derivatives
Chemical Substances	lifitegrast (038E5L962W) ; Sulfones ; Anti-Bacterial Agents ; Phenylalanine (47E5O17Y3R)
Language	English
Publishing date	2023-12-21
Publishing country	United States
Document type	Journal Article ; Comment
ZDB-ID	2701705-9
ISSN	2168-6173 ; 2168-6165
ISSN (online)	2168-6173
ISSN	2168-6165
DOI	10.1001/jamaophthalmol.2023.5751
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Article ; Online: Harms were detected but not reported in six clinical trials of gabapentin.

Mayo-Wilson, Evan / Qureshi, Riaz / Hong, Hwanhee / Chen, Xiwei / Li, Tianjing

Journal of clinical epidemiology

2023 Volume 164, Page(s) 76–87

Abstract: Objectives: We sought to assess and report harms that were observed but not disclosed previously in clinical trials of gabapentin.: Study design and setting: We reanalyzed individual participant data from six randomized parallel trials of gabapentin ... ...

Abstract	Objectives: We sought to assess and report harms that were observed but not disclosed previously in clinical trials of gabapentin. Study design and setting: We reanalyzed individual participant data from six randomized parallel trials of gabapentin for neuropathic pain, and we conducted meta-analyses. Between 1996 and 2003, adult participants were assigned to gabapentin (600 mg-3,600 mg per day) or placebo for 7-14 weeks. We calculated the proportion of participants with: one or more adverse events (AEs), one or more serious AEs, discontinued, discontinued because AEs. We also estimated effects on AEs at three levels of aggregation using COSTART, a hierarchical system for classifying AEs: body system, midlevel system, preferred term. Results: We found evidence of important harms that were neither included in published trial reports nor included in systematic reviews. Aggregating related harms led to greater confidence that gabapentin might harm the nervous system and possibly the digestive, metabolic and nutritional, respiratory, sensory, and urogenital body systems. Nervous system harms were more common than previous reports suggest. Conclusion: Clinical trials identified harms that were not reported publicly, and journal articles overstated uncertainty about harms. Relying on journal articles to evaluate gabapentin's harms could contribute to incomplete and misleading conclusions in systematic reviews and guidelines. To prevent bias arising from the selective nonreporting of results, journal articles should describe how to access data for all harms observed in clinical trials (e.g., by sharing individual participant data).
MeSH term(s)	Adult ; Humans ; Gabapentin/adverse effects ; Neuralgia/drug therapy ; Randomized Controlled Trials as Topic
Chemical Substances	Gabapentin (6CW7F3G59X)
Language	English
Publishing date	2023-10-21
Publishing country	United States
Document type	Journal Article ; Meta-Analysis
ZDB-ID	639306-8
ISSN	1878-5921 ; 0895-4356
ISSN (online)	1878-5921
ISSN	0895-4356
DOI	10.1016/j.jclinepi.2023.10.014
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Article ; Online: Author, study, and publication metrics of brief reports and full-length research articles in ophthalmology journals.

Kang, Chaerim / Lin, John C / Qureshi, Riaz / Scherer, Roberta / Greenberg, Paul B

Clinical & experimental ophthalmology

2023 Volume 51, Issue 2, Page(s) 172–177

MeSH term(s)	Humans ; Ophthalmology ; Benchmarking ; Periodicals as Topic ; Publishing
Language	English
Publishing date	2023-01-09
Publishing country	Australia
Document type	Letter
ZDB-ID	2014008-3
ISSN	1442-9071 ; 1442-6404
ISSN (online)	1442-9071
ISSN	1442-6404
DOI	10.1111/ceo.14196
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