Development and Evaluation of a Framework for Identifying and Addressing Spin for Harms in Systematic Reviews of Interventions.

"Spin" refers to misleading reporting, interpretation, and extrapolation of findings in primary and secondary research (such as in systematic reviews). The study of spin primarily focuses on beneficial outcomes. The objectives of this research were threefold: first, to develop a framework for identifying spin associated with harms in systematic reviews of interventions; second, to apply the framework to a set of reviews, thereby pinpointing instances where spin may be present; and finally, to revise the spin examples, offering guidance on how spin can be rectified.The authors developed their framework through an iterative process that engaged an international group of researchers specializing in spin and reporting bias. The framework comprises 12 specific types of spin for harms, grouped by 7 categories across the 3 domains (reporting, interpretation, and extrapolation). The authors subsequently gathered instances of spin from a random sample of 100 systematic reviews of interventions. Of the 58 reviews that assessed harm and the 42 that did not, they found that 28 (48%) and 6 (14%), respectively, had at least 1 of the 12 types of spin for harms. Inappropriate extrapolation of the results and conclusions for harms to populations, interventions, outcomes, or settings not assessed in a review was the most common category of spin in 17 of 100 reviews.The authors revised the examples to remove spin, taking into consideration the context (for example, medical discipline, source population), findings for harms, and methodological limitations of the original reviews. They provide guidance for authors, peer reviewers, and editors in recognizing and rectifying or (preferably) avoiding spin, ultimately enhancing the clarity and accuracy of harms reporting in systematic review publications.

Studying harms of interventions with an equity lens in randomized trials.

Equity and health equity are fundamental pillars in fostering a just and inclusive society. While equity underscores fairness in resource allocation and opportunity, health equity aims to eradicate avoidable health disparities among social groups. The concept of harms in interventions-undesirable consequences associated with the use of interventions-often varies across populations due to biological and social factors, necessitating a nuanced understanding. An equity lens reveals disparities in harm distribution, urging researchers and policymakers to address these differences in their decision-making processes. Furthermore, interventions, even well-intentioned ones, can inadvertently exacerbate disparities, emphasizing the need for comprehensive harm assessment. Integrating equity considerations in research practices and trial methodologies, through study design or through practices such as inclusive participant recruitment, is pivotal in advancing health equity. By prioritizing interventions that address disparities and ensuring inclusivity in research, we can foster a more equitable healthcare system.

Patient barriers and facilitators for making environmental and behavioral modifications for dry eye in the United States.

BACKGROUND: Managing dry eye disease (DED) is expensive. Often, prescribed treatments improve clinical signs but not patient-reported symptoms. In large surveys, clinicians and patients ranked environmental and behavioral modifications among the most important DED-related research priorities. Our purpose was to investigate the barriers to and facilitators of use of these modifications by patients with DED in the United States and how their use may be impacted by socioeconomic status (SES). METHODS: Using Qualtrics, we conducted an anonymous online survey of adults with DED living in the United States in August to September 2022. Patients were identified through the Dry Eye Foundation, Sjögren's Foundation, and a DED clinic in Colorado. We used an established index for classifying respondent SES based on education, household income, and employment. Outcomes included use of environmental and behavioral modifications and barriers to and facilitators of their use. RESULTS: We included 754 respondents (SES: 382 low, 275 high, and 97 unclear). Most were aged 18 to 49 years (67%), female (68%), and White (76%) and reported dealing with DED for ≤5 years (67%). The most frequent modifications were taking breaks to rest eyes (68%), increasing water intake (68%), and using hot/cold compresses (52%). For these three, the biggest facilitators were as follows: belief that the modification works (27 to 37%), being recommended it (24 to 26%), and ease of use/performance (21 to 32%). Across modifications, the biggest barriers were difficulty of use (55%), lack of family/employer/social/community support (33%), and lack of awareness (32%). The data do not suggest discernible patterns of differences in barriers or facilitators by SES. CONCLUSIONS: Greater emphasis should be placed on explaining to patients how environmental and behavioral modifications might mitigate DED. Employers and members of patients' support systems should be guided regarding how best to support patients in managing DED symptoms.

Social Determinants of Dry Eye in the United States: A Systematic Review.

PURPOSE: To conduct a systematic review to summarize current evidence on associations between social determinants of health (SDOH) indicators and dry eye in the United States. DESIGN: Systematic review. METHODS: We followed a protocol registered on Open Science Framework to include studies that examined associations between SDOH indicators and dry eye. We mapped SDOH indicators to 1 of the 5 domains following the Healthy People 2030 framework and categorized dry eye measures into "dry eye diagnosis and care," "dry eye symptoms," or "ocular surface parameters." We summarized the direction of association between SDOH indicators and dry eye as worsening, beneficial, or null. We used items from the Newcastle Ottawa Scale to assess risk of bias. RESULTS: Eighteen studies reporting 51 SDOH indicators, mostly mapped to the neighborhood and built environment domain, were included. Thirteen studies were judged at high risk of bias. Fifteen of 19 (79%) associations revealed an increase in the diagnosis of dry eye or delayed specialty care for it. Thirty-four of 56 (61%) associations unveiled exacerbated dry eye symptoms. Fifteen of 23 (65%) found null associations with corneal fluorescein staining. Ten of 22 (45%) associations revealed an increased tear break up time (45%) whereas another 10 (45%) showed null associations. CONCLUSIONS: Most SDOH indicators studied were associated with unfavorable dry eye measures, such as a higher disease burden, worse symptoms, or delayed referral, in the United States. Future investigations between SDOH and dry eye should use standardized instruments and address the domains in which there is an evidence gap.

Prevalence of dry eye and Meibomian gland dysfunction in Central and South America: a systematic review and meta-analysis.

BACKGROUND: Dry eye is one of the most common ophthalmic conditions and can significantly impact quality of life. Meibomian gland dysfunction (MGD) is a major cause of evaporative dry eye. We sought to conduct a systematic review and meta-analysis to estimate the prevalence and incidence of dry eye and MGD in Central and South America and to identify factors associated with disease burden. METHODS: Data sources Ovid MEDLINE and Embase. STUDY SELECTION: A search conducted on August 16, 2021, identified studies published between January 1, 2010, and August 16, 2021, with no restrictions regarding participant age or language of publication. Case reports, case series, case-control studies, and interventional studies were excluded. DATA EXTRACTION AND SYNTHESIS: The review was based on a protocol registered on PROSPERO (CRD42021256934). Risk of bias was assessed in duplicate using a risk of bias tool designed for the purposes of descriptive epidemiological studies. Data were extracted by one investigator and verified by another for accuracy. Prevalence of dry eye and MGD were grouped based on study participant characteristics. MAIN OUTCOMES AND MEASURES: Prevalence and incidence of dry eye and MGD in Central and South America. Summary estimates from meta-analysis with 95% confidence intervals (CI). RESULTS: Fourteen studies (11,594 total participants) were included. The population prevalence of dry eye was 13% (95% CI, 12%-14%) in Brazil and 41% (95% CI, 39%-44%) in Mexico based on one study each. Meta-analyses suggested that dry eye prevalence was 70% among indoor workers (95% CI, 56%-80%; I2, 82%; 3 studies), 71% among students (95% CI, 65%-77%; I2, 92%; 3 studies), and 83% in general ophthalmology clinics (95% CI, 77%-88%; I2, 88%; 2 studies). MGD prevalence ranged from 23% among indoor workers (95% CI, 16%-31%; 1 study) to 68% in general ophthalmology clinics (95% CI, 62%-72%; 1 study). No studies reported incidence of dry eye or MGD. CONCLUSIONS: This systematic review and meta-analysis demonstrated considerable variation in the published prevalence of dry eye and MGD among the general population and subpopulations in Central and South America. Local and subpopulation estimates of dry eye disease burden may be valuable to assist needs assessments and implementation of measures to mitigate the condition.

Interventions for Dry Eye: An Overview of Systematic Reviews.

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.

Prolonged facemask wearing among hospital workers and dry eye - a mixed-methods study.

BACKGROUND: Prolonged facemask wearing may have negatively affected essential workers with dry eye. We conducted a mixed-methods study to examine and understand the associations of the ocular surface, periocular environment, and dry eye-related symptoms among hospital workers across the job spectrum with prolonged facemask use. METHODS: We recruited clinical and non-clinical hospital workers with self-reported symptoms of dry eye and prolonged facemask use. We measured symptoms using the 5-item Dry Eye Questionnaire and the Ocular Surface Disease Index (OSDI). Objective ocular signs included corneal and conjunctival staining, fluorescein tear break up time (TBUT), meibography, tear film interferometry, and periocular humidity. We compared symptoms and signs across levels of periocular humidity, dry eye severity, facemask type, and job type. Participants with moderate or severe dry eye symptoms (OSDI > = 23) were invited for a semi-structured, one-on-one interview. RESULTS: We enrolled 20 clinical and 21 non-clinical hospital workers: 27% were 40 years or older, 76% were female, 29% reported a race other than White, and 20% were Hispanic. Seventeen individuals participated in the semi-structured interviews. From the quantitative analyses, we found that 90% of participants reported worsened severity of dry eye at work due to facemasks. Although wearing facemasks resulted in higher periocular humidity levels compared with not wearing facemasks, 66% participants reported increased airflow over their eyes. Findings from the qualitative interviews supported the finding that use of facemasks worsened dry eye symptoms, especially when facemasks were not fitted around the nose. The data did not suggest that non-clinical hospital workers experienced a greater impact of dry eye than clinical workers. CONCLUSIONS: Healthcare providers and patients with dry eye should be educated about the discomfort and the ocular surface health risks associated with inadequately fitted facemasks. Wearing a fitted facemask with a pliable nose wire appears to mitigate the upward airflow.

Harms were detected but not reported in six clinical trials of gabapentin.

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).

Diagnostic performance of deep learning in infectious keratitis: a systematic review and meta-analysis protocol.

INTRODUCTION: Infectious keratitis (IK) represents the fifth-leading cause of blindness worldwide. A delay in diagnosis is often a major factor in progression to irreversible visual impairment and/or blindness from IK. The diagnostic challenge is further compounded by low microbiological culture yield, long turnaround time, poorly differentiated clinical features and polymicrobial infections. In recent years, deep learning (DL), a subfield of artificial intelligence, has rapidly emerged as a promising tool in assisting automated medical diagnosis, clinical triage and decision-making, and improving workflow efficiency in healthcare services. Recent studies have demonstrated the potential of using DL in assisting the diagnosis of IK, though the accuracy remains to be elucidated. This systematic review and meta-analysis aims to critically examine and compare the performance of various DL models with clinical experts and/or microbiological results (the current 'gold standard') in diagnosing IK, with an aim to inform practice on the clinical applicability and deployment of DL-assisted diagnostic models. METHODS AND ANALYSIS: This review will consider studies that included application of any DL models to diagnose patients with suspected IK, encompassing bacterial, fungal, protozoal and/or viral origins. We will search various electronic databases, including EMBASE and MEDLINE, and trial registries. There will be no restriction to the language and publication date. Two independent reviewers will assess the titles, abstracts and full-text articles. Extracted data will include details of each primary studies, including title, year of publication, authors, types of DL models used, populations, sample size, decision threshold and diagnostic performance. We will perform meta-analyses for the included primary studies when there are sufficient similarities in outcome reporting. ETHICS AND DISSEMINATION: No ethical approval is required for this systematic review. We plan to disseminate our findings via presentation/publication in a peer-reviewed journal. PROSPERO REGISTRATION NUMBER: CRD42022348596.

Are ChatGPT and large language models "the answer" to bringing us closer to systematic review automation?

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.

TFOS Lifestyle - Evidence quality report: Advancing the evaluation and synthesis of research evidence.

Evidence-based practice is a dominant paradigm in healthcare that emphasizes the importance of ensuring the translation of the best available, relevant research evidence into practice. An Evidence Quality Subcommittee was established to provide specialized methodological support and expertise to promote rigorous and evidence-based approaches for the Tear Film and Ocular Surface Society (TFOS) Lifestyle Epidemic reports. The present report describes the purpose, scope, and activity of the Evidence Quality Subcommittee in the undertaking of high-quality narrative-style literature reviews, and leading prospectively registered, reliable systematic reviews of high priority research questions, using standardized methods for each topic area report. Identification of predominantly low or very low certainty evidence across the eight systematic reviews highlights a need for further research to define the efficacy and/or safety of specific lifestyle interventions on the ocular surface, and to clarify relationships between certain lifestyle factors and ocular surface disease. To support the citation of reliable systematic review evidence in the narrative review sections of each report, the Evidence Quality Subcommittee curated topic-specific systematic review databases and relevant systematic reviews underwent standardized reliability assessment. Inconsistent methodological rigor was noted in the published systematic review literature, emphasizing the importance of internal validity assessment. Based on the experience of implementing the Evidence Quality Subcommittee, this report makes suggestions for incorporation of such initiatives in future international taskforces and working groups. Content areas broadly relevant to the activity of the Evidence Quality Subcommittee, including the critical appraisal of research, clinical evidence hierarchies (levels of evidence), and risk of bias assessment, are also outlined.

Conducting separate reviews of benefits and harms could improve systematic reviews and meta-analyses.

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.

TFOS lifestyle: Impact of societal challenges on the ocular surface.

Societal factors associated with ocular surface diseases were mapped using a framework to characterize the relationship between the individual, their health and environment. The impact of the COVID-19 pandemic and mitigating factors on ocular surface diseases were considered in a systematic review. Age and sex effects were generally well-characterized for inflammatory, infectious, autoimmune and trauma-related conditions. Sex and gender, through biological, socio-economic, and cultural factors impact the prevalence and severity of disease, access to, and use of, care. Genetic factors, race, smoking and co-morbidities are generally well characterized, with interdependencies with geographical, employment and socioeconomic factors. Living and working conditions include employment, education, water and sanitation, poverty and socioeconomic class. Employment type and hobbies are associated with eye trauma and burns. Regional, global socio-economic, cultural and environmental conditions, include remoteness, geography, seasonality, availability of and access to services. Violence associated with war, acid attacks and domestic violence are associated with traumatic injuries. The impacts of conflict, pandemic and climate are exacerbated by decreased food security, access to health services and workers. Digital technology can impact diseases through physical and mental health effects and access to health information and services. The COVID-19 pandemic and related mitigating strategies are mostly associated with an increased risk of developing new or worsening existing ocular surface diseases. Societal factors impact the type and severity of ocular surface diseases, although there is considerable interdependence between factors. The overlay of the digital environment, natural disasters, conflict and the pandemic have modified access to services in some regions.

Predictors of Citations for Original Research in Ophthalmology.

There is a dearth of literature on factors associated with citation of publications in ophthalmology. We investigated predictors of citations for original ophthalmologic research articles based on author, study, and journal characteristics. In accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines (PRISMA), we extracted articles that studied the leading cause of vision impairment in the United States (cataract, diabetic retinopathy, age-related macular degeneration, and glaucoma) and were published in the top fifteen ophthalmology journals with the highest impact factors that accepted original research. Descriptive statistics, one-way analysis of variance (ANOVA) tests, and negative binomial regression were used to compare citation counts based on author, study, and journal characteristics. In this study, author research productivity, journal impact factor, study funding, and location in high-income countries were predictors of increased citation in ophthalmology.

Risk Factors for Vision Loss among Nursing Home Residents: A Cross-Sectional Analysis.

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.

Prevalence and Incidence of Dry Eye and Meibomian Gland Dysfunction in the United States: A Systematic Review and Meta-analysis.

Importance: Dry eye is a common clinical manifestation, a leading cause of eye clinic visits, and a significant societal and personal economic burden in the United States. Meibomian gland dysfunction (MGD) is a major cause of evaporative dry eye. Objective: To conduct a systematic review and meta-analysis to obtain updated estimates of the prevalence and incidence of dry eye and MGD in the United States. Data Sources: Ovid MEDLINE and Embase. Study Selection: A search conducted on August 16, 2021, identified studies published between January 1, 2010, and August 16, 2021, with no restrictions regarding participant age or language of publication. Case reports, case series, case-control studies, and interventional studies were excluded. Data Extraction and Synthesis: The conduct of review followed a protocol registered on PROSPERO (CRD42021256934). PRISMA guidelines were followed for reporting. Joanna Briggs Institute and Newcastle Ottawa Scale tools were used to assess risk of bias. Data extraction was conducted by 1 reviewer and verified by another for accuracy. Prevalence of dry eye and MGD were combined in separate meta-analyses using random-effects models. Main Outcomes and Measures: Prevalence and incidence of dry eye and MGD in the United States. Summary estimates from meta-analysis of dry eye and MGD prevalence with 95% CI and 95% prediction intervals (95% PI). Results: Thirteen studies were included in the systematic review. Dry eye prevalence was reported by 10 studies, dry eye incidence by 2 studies, and MGD prevalence by 3 studies. Meta-analysis estimated a dry eye prevalence of 8.1% (95% CI, 4.9%-13.1%; 95% PI, 0%-98.9%; 3 studies; 9 808 758 participants) and MGD prevalence of 21.2% (95% CI, 7.2%-48.3%; 95% PI, 0%-100%; 3 studies; 19 648 participants). Dry eye incidence was 3.5% in a population 18 years and older and 7.8% in a population aged 68 years and older. No studies reported MGD incidence. Conclusions and Relevance: This systematic review and meta-analysis demonstrated uncertainty about the prevalence and incidence of dry eye and MGD in the United States. Population-based epidemiological studies that use consistent and validated definitions of dry eye and MGD are needed for higher-certainty estimates of dry eye and MGD prevalence and incidence in the United States.

Comparing the Value of Data Visualization Methods for Communicating Harms in Clinical Trials.

In clinical trials, harms (i.e., adverse events) are often reported by simply counting the number of people who experienced each event. Reporting only frequencies ignores other dimensions of the data that are important for stakeholders, including severity, seriousness, rate (recurrence), timing, and groups of related harms. Additionally, application of selection criteria to harms prevents most from being reported. Visualization of data could improve communication of multidimensional data. We replicated and compared the characteristics of 6 different approaches for visualizing harms: dot plot, stacked bar chart, volcano plot, heat map, treemap, and tendril plot. We considered binary events using individual participant data from a randomized trial of gabapentin for neuropathic pain. We assessed their value using a heuristic approach and a group of content experts. We produced all figures using R and share the open-source code on GitHub. Most original visualizations propose presenting individual harms (e.g., dizziness, somnolence) alone or alongside higher level (e.g., by body systems) summaries of harms, although they could be applied at either level. Visualizations can present different dimensions of all harms observed in trials. Except for the tendril plot, all other plots do not require individual participant data. The dot plot and volcano plot are favored as visualization approaches to present an overall summary of harms data. Our value assessment found the dot plot and volcano plot were favored by content experts. Using visualizations to report harms could improve communication. Trialists can use our provided code to easily implement these approaches.

Effectiveness of interventions for dry eye: a protocol for an overview of systematic reviews.

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.