Association of serum levels of inflammatory cytokines with retinopathy of prematurity in preterm infants.

Introduction: Retinopathy of prematurity (ROP) is a retinal vascular developmental disease associated with risks factors such as supplementary oxygen use or low birth weight/early gestational age. Multiple studies have reported associations between ROP and systemic inflammation. In this study, we investigated serum cytokines associated with ROP development and severity and assessed their applicability as potential biomarkers of ROP. Methods: This prospective study was conducted at an institutional referral center between 2019 and 2021. To measure the serum levels of 40 inflammatory cytokines in eligible premature patients, we collected their serum samples during the enrollment of patients or the intravitreal injection of anti-vascular endothelial growth factor (VEGF) agents and after 2 and 4 weeks. Results: Fifty patients were enrolled. In patients with type 1 ROP who received anti-VEGF agents (n = 22), the levels of serum intercellular adhesion molecule-1 decreased significantly (p < 0.05) at 4 weeks compared with the baseline level, whereas those of serum granulocyte-macrophage colony-stimulating factor increased significantly (p < 0.05). In patients with ROP who did not require any treatment (n = 14), no significant change was noted in the level of any of the 40 inflammatory cytokines. In control infants without ROP (n = 14), the serum levels of tumor necrosis factor-α, interleukin (IL)-15, and IL-12p40 increased significantly (p < 0.05) at 4 weeks. The changes in the levels of serum inflammatory cytokines did not vary significantly among the aforementioned three groups. A generalized estimating equation indicated that zone 1 ROP, stage 3 ROP, older postmenstrual age, respiratory distress syndrome, necrotizing enterocolitis, and sepsis were associated with the changes in serum cytokine levels. Conclusions: Although significant changes (compared with baseline) were observed in the serum levels of certain inflammatory cytokines in patients with type 1 ROP and infants without ROP, no significant difference in cytokine level fluctuations were noted among the three groups. Changes in serum inflammatory cytokine levels may not predict ROP development or severity. Additional comprehensive studies are warranted to establish their definitive role and significance in ROP, emphasizing the need for continued research in this area.

IFITM3 promotes malignant progression, cancer stemness and chemoresistance of gastric cancer by targeting MET/AKT/FOXO3/c-MYC axis.

BACKGROUND: Targeting the HGF/MET signaling pathway has been a viable therapeutic strategy for various cancer types due to hyperactivation of HGF/MET axis occurs frequently that leads to detrimental cancer progression and recurrence. Deciphering novel molecule mechanisms underlying complex HGF/MET signaling network is therefore critical to development of effective therapeutics for treating MET-dependent malignancies. RESULTS: Using isobaric mass tag-based quantitative proteomics approach, we identified IFITM3, an interferon-induced transmembrane protein that was highly expressed in micro-dissected gastric cancer (GC) tumor regions relative to adjacent non-tumor epithelia. Analyses of GC clinical specimens revealed that expression IFITM3 was closely correlated to advanced pathological stages. IFITM3 has been reported as a PIP3 scaffold protein that promotes PI3K signaling. In present study, we unprecedentedly unraveled that IFITM3 associated with MET and AKT to facilitate HGF/MET mediated AKT signaling crosstalk in suppressing FOXO3, consequently leading to c-MYC mediated GC progression. In addition, gene ontology analyses of the clinical GC cohort revealed significant correlation between IFITM3-associated genes and targets of c-MYC, which is a crucial downstream effector of HGF/MET pathway in cancer progression. Moreover, we demonstrated ectopic expression of IFITM3 suppressed FOXO3 expression, consequently led to c-MYC induction to promote tumor growth, cell metastasis, cancer stemness as well as chemoresistance. Conversely, depletion of IFITM3 resulted in suppression of HGF triggered cellular growth and migration via inhibition of AKT/c-MYC signaling in GC. CONCLUSIONS: In summary, our present study unveiled a novel regulatory mechanism for c-MYC-driven oncogenesis underlined by IFITM3-mediated signaling crosstalk between MET associated AKT signaling cascade.

Predicting human papillomavirus vaccine uptake in men who have sex with men the influence of vaccine price and receiving an HPV diagnosis.

BACKGROUND: To understand how human papillomavirus (HPV) screening results, HPV-related knowledge and attitudes are related to vaccination intention in three cost ranges and the actual vaccination behavior in a community sample of men who have sex with men (MSM). METHODS: MSM aged 20 years of age or older were recruited between October 2015 and May 2016 from community health centers that provide HIV testing and consultation services in Southern Taiwan and on social media. MSM were seen at baseline and again at 6 months after baseline in a cohort study. The baseline study included 253 individuals; 182 of them returned for the 6th-month follow-up. At each visit, MSM were asked to receive HPV screening and filled out a questionnaire. Structural equation modeling was used to test whether attitudinal factors and HPV screening results from the baseline affect their self-reported actual vaccine uptake at the in 6th-month follow-up. RESULTS: Our research included 171 participants from the cohort because they had full information of the study variables (mean ± SD age = 29.21 ± 6.18). Our model showed good model fit using indices such as the comparative fit index (value = 0.998) and root mean square error of approximation (value = 0.013). HPV knowledge can predict those who have intention to take up HPV vaccine no matter what the price (p = .02), and then predict vaccine uptake at the follow-up (p < .001). A positive HPV screening result can predict vaccine uptake at the follow-up (p = .004). CONCLUSION: Our findings highlight the impact of vaccine price and HPV screening results on the intention and uptake of HPV vaccine. It is important to raise awareness of HPV in male populations. Clinicians and health educators should establish a safe and private environment for male patients for inquiring about HPV vaccine and HPV-related cancers.

Outdoor walking better? environmental elements of cardiorespiratory fitness training trails.

In metropolitan areas where land resources are scarce, trails are a more suitable environment for cardiorespiratory fitness training for modern people. Previous studies have demonstrated that cardiorespiratory fitness is an important factor in assessing individual health and have focused on individual training performance, but the relationship between environment and cardiorespiratory fitness training participants has rarely been investigated. The purpose of this study was to investigate the demands for outdoor cardiorespiratory fitness training and a favorable trail environment by comparing the differences in exercise intensity and perceptions between outdoor and indoor environments. In this study, information on physical data, psychological feedback, and visual atmosphere was collected from nine participants during each phase of moderate intensity cardiorespiratory fitness training in indoor and outdoor environments. The results revealed that outdoor cardiorespiratory fitness training provided participants with lower training intensity during the active exercise phase and higher heart rate during the stretching phase compared to indoor training. The participants paid more attention to the slope, length, pavement, Spaciousness, and width of the trails and the circuitous route. The change of the visual atmosphere and the scenery for the environmental factors were the important factors to motivate the participants to train. The results of the study could assist participants to understand a favorable cardiorespiratory training environment and design a suitable training program, as well as provide a model for trail planning and design for government.

Dream Big: Effects of Capitals, Socioeconomic Status, Negative Culture, and Educational Aspirations Among the Senior High School Student Athletes.

To understand the impact of social, financial, cultural capitals, negative culture, and socioeconomic status of families on educational aspiration in the senior high school student athletes, it will be beneficial to promote their career developments. The purpose of this study is to explore the influence of ethnicity, year of sport experience family income, the educational expectations of significant others, and the three aforementioned types of capital on educational aspiration among the senior high school student athletes. This study was conducted with a sample of 262 U-18 male baseball student athletes. Of the participants, 20.20% had attained the qualifications to play on the national team. The results showed that monthly family income positively affected social capital and positively indirectly affected educational aspirations through social capital, whereas monthly family income negatively affected negative culture and positively affected educational aspirations through negative culture. Moreover, social capital positively affected educational aspirations compared with negative culture negatively affected educational aspirations. The results serve as a reference for the formulation of educational policy as it relates to student athletes.

Art and Cultural Participation and Life Satisfaction in Adults: The Role of Physical Health, Mental Health, and Interpersonal Relationships.

Many different forms of art and cultural participation, for example, visiting museums and galleries, have received increasing attention as an important new focus for public health. While a growing body of evidence suggests that art and cultural participation enhance human health and well-being in the West, the research is just in the infancy in the East. The purpose of this study was to explore the effects of art and cultural participation of museums and galleries on life satisfaction intervened and controlled by physical and mental health and interpersonal relationships and individual's background. This study adopted large-sample data from the seventh period of the Taiwan Social Change Survey. The sample population comprised 2,034 adult participants, involving 1,042 males and 992 females. The average age of the respondents was 47.67 ± 17.48 years. The results showed that individuals aged 30-64 years with an average monthly income between NT$20,000-NT$40,000 had a higher frequency of art and cultural participation of museums and galleries. Women under 29 years reported better life satisfaction. Individuals with a higher frequency of art and cultural participation of museums and galleries affected life satisfaction not only directly but also indirectly through interpersonal relationships, particularly among women and the elderly. Individuals who visited museums and galleries more frequently had greater life satisfaction and higher frequency of interpersonal contact. This was particularly evident in older females. Art and cultural participation of museums and galleries directly affected individual's life satisfaction and indirectly affected it via interpersonal relationships after controlling for gender, age, and monthly income. These findings indicate that visiting museums and galleries can enhance the frequency of interpersonal interactions and life satisfaction.

Prevalence and risk factors of anogenital human papillomavirus infection in a community sample of men who have sex with men in Taiwan: baseline findings from a cohort study.

OBJECTIVES: Men who have sex with men (MSM) are a highly neglected population in the current recommendation of girls-only human papillomavirus (HPV) vaccination programmes in many countries. To better assess the cost effectiveness of HPV vaccination among men requires data on the prevalence of HPV infection in MSM using a community sample, which is still sparse in several regions. We examined the prevalence of and factors associated with anogenital HPV infection among MSM in Taiwan. METHODS: MSM 20 years of age and older were recruited from the community and social media in Taiwan in 2015-2016 and screened for HPV infection to detect 37 genotypes. MSM were seen at baseline and were/will be seen at 6, 12, 24 and 36 months. Men completed a questionnaire regarding their sexual experiences. Multivariable regression analyses were conducted to identify associated behavioural risk factors using the baseline data. RESULTS: A total of 253 MSM were recruited; 87 % were below 35 years of age. Diagnosis of HIV was reported in 4% of men; just over 20% had three or more anal sex partners in the past year. The prevalence of any tested HPV type was 29.4% at the anal site and 11% at the penile site. One quarter of MSM were infected with any of the 9-valent vaccine HPV types. Anal HPV detection was associated with having three or more receptive anal sex partners in the past year (adjusted odds ratio (aOR)=2.92, 95% CI 1.29 to 6.61) and having older sex partners (aOR=2.51, 95% CI 1.07 to 5.90). CONCLUSIONS: Our data provide the base to calculate the reproductive rate for HPV transmission in a low-risk community sample and cost-effectiveness to include men in HPV vaccination policies. Adding evidence from a community sample adds comprehensiveness for future estimates of disease transmission and vaccine effectiveness.

The Process of Constructing a Health Tourism Destination Index.

The purpose of the study is to identify a set of key indicators with weightings for health tourism destinations by using an advanced analytic hierarchy process (AHP) method, derived from the official, academic, and professional opinions of the experts. The AHP method allocated weightings to the evaluation criteria selected by the fifteen experts. After expert evaluations were conducted, the three dimensions and eleven sub-dimensions of the initial health tourism destination were obtained as follows: (1) special demands and indications-medical care, health promotion, and tourism and leisure; (2) natural environment-climate, air, water, and light; (3) leisure activities and general demands-sports, therapeutic activities, interactions with animals and plants, and diet. The results revealed that the dimensions of special demands and indications were given the most attention and that the sub-dimensions of sports promotion were the highest ranked by expert groups. The official and academic opinions suggested that health tourism destinations should focus on special demands and indications, while professionals tended to consider the natural environment as a primary concern. In particular, they considered that good air quality can help people release pressure, relax, activate lymphocytes, improve immune function, and enhance disease immunity. The health tourism destination index can contribute to the overall strategic planning process by identifying improvements in activities and enhancing competitiveness in health tourism management by using benchmarking to further improve tourists' experience and satisfaction.

Sexual network and detection of anogenital human papillomavirus in a community cohort of men who have sex with men in Taiwan.

OBJECTIVES: We examined the association between anogenital human papillomavirus (HPV) infection and sexual networks in men who have sex with men (MSM). METHODS: A total of 253 MSM, 20 years of age and older, were recruited from the community in Southern Taiwan in 2015-2016. At baseline and at each follow-up visit, MSM were screened for HPV to identify 37 HPV genotypes. At the six-month follow-up, MSM were asked to fill out an egocentric network assessment and to report the last five persons with whom they had sex regarding the characteristics of sexual behavior with each network member. RESULTS: A total of 182 participants (71.9%) returned for the follow-up and one third had at least one HPV type detected. A higher level of bridging network position calculated by the level of constraints in the network was significantly less likely to have HPV detection at the anal site. A high level of concurrency was associated with penile HPV detection (AOR = 3.16, 95% CI = 1.01-9.86). CONCLUSIONS: Identifying network-related characteristics can advance our understanding of high-risk populations and for prioritizing HPV vaccine recommendations.

Generation of Osteosarcomas from a Combination of Rb Silencing and c-Myc Overexpression in Human Mesenchymal Stem Cells.

Osteosarcoma (OS) was a malignant tumor occurring with unknown etiology that made prevention and early diagnosis difficult. Mesenchymal stem cells (MSCs), which were found in bone marrow, were claimed to be a possible origin of OS but with little direct evidence. We aimed to characterize OS cells transformed from human MSCs (hMSCs) and identify their association with human primary OS cells and patient survival. Genetic modification with p53 or retinoblastoma (Rb) knockdown and c-Myc or Ras overexpression was applied for hMSC transformation. Transformed cells were assayed for proliferation, differentiation, tumorigenecity, and gene expression profile. Only the combination of Rb knockdown and c-Myc overexpression successfully transformed hMSCs derived from four individual donors, with increasing cell proliferation, decreasing cell senescence rate, and increasing ability to form colonies and spheres in serum-free medium. These transformed cells lost the expression of certain surface markers, increased in osteogenic potential, and decreased in adipogenic potential. After injection in immunodeficient mice, these cells formed OS-like tumors, as evidenced by radiographic analyses and immunohistochemistry of various OS markers. Microarray with cluster analysis revealed that these transformed cells have gene profiles more similar to patient-derived primary OS cells than their normal MSC counterparts. Most importantly, comparison of OS patient tumor samples revealed that a combination of Rb loss and c-Myc overexpression correlated with a decrease in patient survival. This study successfully transformed human MSCs to OS-like cells by Rb knockdown and c-Myc overexpression that may be a useful platform for further investigation of preventive and target therapy for human OS. Stem Cells Translational Medicine 2017;6:512-526.

A Social Media-Based Mindful Yoga Program for Pregnant Women in Taiwan.

Social media, a communication tool, is increasingly used to facilitate the engagement of experts (such as a health provider) and other participants in a wide range of programs. However, social media requires study to elucidate its applications under women health-related conditions. This work develops a social media-based mindful yoga program for pregnant women, and delivers media content by ways of Facebook platform and DVD. The results of pilot testing revealed users' preference of using Facebook platform. Developing experience and uses' responses can provide valuable information for further implement socialmedia based interventions.

Smoking Cessation Intervention Preferences Among Urban African Americans: A Mixed Methods Approach.

African Americans suffer disproportionately from smoking-related morbidity and mortality and make more quit attempts but report less success in quitting. Smokers tend to identify more strongly with African American culture. Qualitative interviews were conducted to elicit perceptions toward smoking and intervention content. Seventy-one African American smokers recruited from community locations participated. The majority stated they would not use any cessation aids if trying to quit smoking, despite the availability of free nicotine replacement. Acculturative stress scores were significantly higher in younger participants and those with higher income. Higher African American acculturation did not predict smoking cessation intervention preference. Family and social relationships were cited as both reasons for wanting to quit and reasons for continuing to smoke. Based on these findings, interventions for urban African Americans should address household members continuing to smoke, social/family connections, stress management, and cultural identification in urban areas.

Relationship between ethnic backgrounds, family socioeconomic status, leisure participation, and psychological well-being.

Relations between ethnic backgrounds, family socioeconomic status, leisure participation, and psychological well-being were explored. Participants returned 827 valid pencil-and-paper surveys. An increase in student-athlete leisure participation was associated with better psychological well-being and sense of accomplishment. Compared with Aboriginal student-athletes, Han student-athletes had higher passive leisure participation; there was no correlation between their families' socioeconomic status and the student-athletes' leisure participation or psychological well-being.

The effect of CCND1 +870A>G and VEGF +936C>T polymorphisms on oral cancer development and disease-free survival in a Taiwan population.

The association between polymorphisms in vascular endothelial growth factor (VEGF) +936C>T and cyclin D1 (CCND1) +870A>G genes, oral cancer risk, and disease-free survival remains controversial. We found no association between polymorphisms in the CCND1 and VEGF genes and oral cancer development using multivariate logistic regression analysis. Clinical data indicated that the VEGF +936C>T polymorphisms were associated with larger tumor size and advanced cancer stage, but the χ(2) test did not show that CCND1 polymorphisms were associated with larger tumor size and advanced cancer stage. However, Cox proportional hazards model analysis showed no correlation between the VEGF +936C>T polymorphisms and poor disease-free survival. The CCND1 +870A>G polymorphisms (hazard ratio (HR)=1.62, 95% CI=1.10-2.46; adjusted HR=1.63, 95% CI=1.08-2.54) and larger tumor size were associated with poor 5-year disease-free survival by the log rank test and multivariate Cox proportional hazards model analysis. We hypothesized that polymorphisms in CCND1 +870A>G and VEGF +936C>T genes are not correlated with the development of oral cancer. We found the CCND1 +870G allele to be an independent risk factor for poor 5-year disease-free survival in oral cancer patients. VEGF +936C>T polymorphisms were not directly correlated with poor survival, but they might be associated with increased tumor size, which affected our disease-free survival results.

Polymorphisms in the apoptosis-associated genes FAS and FASL and risk of oral cancer and malignant potential of oral premalignant lesions in a Taiwanese population.

BACKGROUND: Our aim was to measure the relationship of FAS (-1377G>A and -670A>G), FASL (-844C>T) gene variants and risk of oral cancer. METHODS: Polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP) analysis was used to determine the FAS and FASL polymorphisms in 294 oral squamous cell carcinoma (OSCC), 53 oral submucous fibrosis (OSF), and 84 oral leukoplakia (OL) patients, as well as in 333 healthy controls. A standardized questionnaire was applied to collect demographic data, and potential confounding factors. JMP statistical software was used to analyze the association. RESULTS: FAS and FASL polymorphisms were not correlated with OSCC development or the malignant potential of OL by simple and multivariate logistic regression. However, a two- to fourfold difference in the risks of betel quid chewing, alcohol consumption, and smoking on OSCC development were observed between participants with different FAS polymorphisms. FAS polymorphisms were significantly correlated with the malignant potential of OSF. Multivariate logistic regression analysis indicated that FAS A(-1377)-G(-670) vs. G(-1377)-A(-670) haplotype (OR = 2.26, 95% CI = 1.16-4.41) was correlated with the malignant potential of OSF. CONCLUSIONS: We suggest that FAS and FASL polymorphisms are not significantly correlated with OSCC development or malignant potential of OL. The impact of substance usage on OSCC development could be differentiated by FAS polymorphisms. FAS A(-1377)-G(-670) haplotype may play a role in the malignant potential of OSF.

Rapid determination of aristolochic acids I and II in herbal products and biological samples by ultra-high-pressure liquid chromatography-tandem mass spectrometry.

Aristolochic acids (AAs) are a mixture of structural-related compounds, in which aristolochic acid I (AA I) and aristolochic acid II (AA II) are reported to be correlated with Aristolochic acid nephropathy (AAN). In this work, a rapid and sensitive ultra-high-pressure liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS) method was developed to determine AA I and AA II in herbal products and biological fluids. By using gradient elution with a mobile phase composed of a mixture of 10mM ammonium formate buffer (pH 3.0) and acetonitrile, AAs could be determined within 10 min. Under optimum UHPLC-MS/MS conditions, the limit of detections was 0.14 and 0.26 ng mL(-1) for AA I and AA II, respectively. Run-to-run repeatability and intermediate precision of peak area for AA I and AA II were less than 5.74% relative standard deviation (RSD). Accuracy was tested by spiking 10, 100 and 1000 ng mL(-1) in rat serum and the recoveries were within 76.5-92.9%. Matrix effects were within 78.8-127.7%. The developed method was successfully applied to determine AA I and AA II in several herbal products and to investigate their pharmacokinetic behavior in female Wister rats. The result shows that the developed UHPLC-MS/MS method is efficient, sensitive, and accurate for the determination of AA I and AA II in herbal products and biological samples.

Efficacy and safety of prostaglandin analogues in patients with predominantly primary open-angle glaucoma or ocular hypertension: a meta-analysis.

BACKGROUND: First-line therapy for primary open-angle glaucoma and ocular hypertension generally involves prostaglandin analogue therapy. The relative efficacy of differing prostaglandin therapy is disputed. METHODS: A meta-analysis was conducted of head-to-head randomized trials of prostaglandin therapies. We included randomized trials assessing head-to-head evaluations of prostaglandin analogues travoprost, latanoprost and bimatoprost in patients with predominantly primary open-angle glaucoma or ocular hypertension. Findings were interpreted in light of equivalence margins. RESULTS: Our search identified 16 eligible trials, of which 15 were included in the meta-analysis. Trials were, in general, poorly reported. We pooled 9 trials assessing IOP-lowering effects of travoprost vs latanoprost (total n = 1098, weighted mean difference [WMD], -0.24 mmHg, 95% CI, -0.87 to 0.38, P = 0.45, I2 = 56%, 95% CI, 0 to 0.77, heterogeneity P = 0.01). Eight trials assessed travoprost vs bimatoprost (total n = 714, WMD, 0.88 mmHg, 95% CI, 0.13 to 1.63, P = 0.02, I2 = 56%, 95% CI, 0% to 78%, heterogeneity P = 0.02). And 8 trials assessed latanoprost vs bimatoprost (total n = 943, WMD, 0.73 mmHg, 95% CI, 0.10 to 1.37, P = 0.02, I2 = 47%, 95% CI, 0% to 74%, heterogeneity P = 0.06). Travoprost was associated with greater incidence of conjunctival hyperemia than latanoprost (RR 5.71, 95% CI, 1.81 to 18.02, P

Safety of topical corticosteroids in pregnancy.

BACKGROUND: Topical corticosteroids are the most frequently prescribed dermatological treatment and are frequently used by pregnant women with skin conditions. However, little is known about their safety in pregnancy. OBJECTIVES: To assess the effects of topical corticosteroids on pregnancy outcomes. SEARCH STRATEGY: On 5th May 2009 we searched the Cochrane Skin Group Specialised Register, the Cochrane Pregnancy and Childbirth Group Specialised Register, CENTRAL (The Cochrane Library 2009, Issue 2), MEDLINE (from 2003), and EMBASE (from 2005). We searched LILACS, CINAHL, British Nursing Index, SCI-EXPANDED, BIOSIS Previews, Conference Papers Index, and Conference Proceedings Citation Index-Science from inception to May 2009. We scanned the bibliographies of the included studies, published reviews, and articles that had cited the included studies. Pharmaceutical companies that have introduced an original topical corticosteroid product were contacted. SELECTION CRITERIA: Randomised controlled trials and cohort studies of topical corticosteroids in pregnant women, and case-control studies comparing maternal exposure to topical corticosteroids between cases and controls were included where outcomes were those we had pre-specified. Outcomes included mode of delivery, congenital abnormality, birthweight, preterm delivery, stillbirth, and low Apgar score. DATA COLLECTION AND ANALYSIS: Two authors independently applied selection criteria, extracted data, and assessed the quality of the included studies. A third author was available for resolving differences of opinion. MAIN RESULTS: Seven studies, including 2 cohort and 5 case-control studies, of 659,675 participants were included. We did not undertake a meta-analysis due to considerable methodological heterogeneity. The available data was limited and mainly on orofacial cleft. Most studies did not find significant associations between topical corticosteroids and pregnancy outcomes including mode of delivery, congenital abnormality, preterm delivery, and stillbirth. One study found a significant association between first trimester topical corticosteroid use and orofacial cleft, and another found a significant association between very potent topical corticosteroids and low birthweight. Nevertheless, all the studies had drawbacks, and the quality of evidence was low to very low. AUTHORS' CONCLUSIONS: Currently limited and inconclusive data are unable to detect an association between topical corticosteroids and congenital abnormality, preterm delivery, or stillbirth. The current evidence shows no statistically significant difference between pregnant women who use and those who do not use topical corticosteroids. However, there does appear to be an association of very potent topical corticosteroids with low birthweight. Cohort studies with comprehensive outcome measures, assessment of effects of corticosteroid potency and dose, application methods, and reasons for giving them, and a very large sample size are needed.

Reporting of noninferiority and equivalence randomized trials for major prostaglandins: a systematic survey of the ophthalmology literature.

BACKGROUND: Standards for reporting clinical trials have improved the transparency of patient-important research. The Consolidated Standards of Reporting Trials (CONSORT) published an extension to address noninferiority and equivalence trials. We aimed to determine the reporting quality of prostaglandin noninferiority and equivalence trials in the treatment of glaucoma. METHODS: We searched, independently and in duplicate, 6 electronic databases for eligible trials evaluating prostaglandins. We abstracted data on reporting of methodological criteria, including reporting of per-protocol [PP] and intention-to-treat [ITT] analysis, sample size estimation with margins, type of statistical analysis conducted, efficacy summaries, and use of hyperemia measures. RESULTS: Trials involving the four major prostaglandin groups (latanoprost, travoprost, bimatoprost, unoprostone) were analyzed. We included 36 noninferiority and 11 equivalence trials. Seventeen out of the included 47 trials (36%, 95% Confidence Intervals [CI]: 24-51) were crossover designs. Only 3 studies (6%, 95% CI: 2-17) reported a presented results of both ITT and PP populations. Twelve studies (26%, 95% CI: 15-39) presented only ITT results but mentioned that PP population had similar results. Thirteen trials (28%, 95% CI: 17-42) presented only PP results with no mention of ITT population results while 17 studies (36%, 95% CI: 24-51) presented only ITT results with no mention of PP population results. Thirty-four (72%, 95% CI: 58-83) of studies adequately described their margin of noninferiority/equivalence. Sequence generation was reported in 22/47 trials (47%, 95% CI: 33-61). Allocation concealment was reported in only 10/47 (21%, 95% CI: 12-35) of the trials. Thirty-five studies (74%, 95% CI: 60-85) employed masking of at least two groups, 4/47 (9%, 95% CI: 3-20) masked only patients and 8/47 (17%, 95% CI: 9-30) were open label studies. Eight (17%, 95% CI: 9-30) of the 47 trials employed a combined test of noninferiority and superiority. We also found 6 differing methods of evaluating hyperemia. CONCLUSION: The quality of reporting noninferiority/equivalency trials in the field of glaucoma is markedly heterogeneous. The adoption of the extended CONSORT statement by journals will potentially improve the transparency of this field.