Risk of bias analysis in diabetic retinopathy randomized clinical trials evaluated by RoB-1 tool from Cochrane systematic reviews

The objective of clinical trials is to answer about intervention in the real-world, for which they must be properly designed and executed by presenting the results reliably with the findings and in a clear way. OBJECTIVES: To identify the risk of bias in clinical trials about interventions for diabetic retinopathy and/or diabetic macular edema from Cochrane systematic reviews. METHODS: A sensitive search strategy was designed to search Cochrane systematic reviews of interventions in diabetic retinopathy and diabetic macular edema. The assessment of the risk of bias was captured as presented by the author. FINDINGS: We found eight SR and one meta-analysis network totaling 116 randomized clinical trials. Our sample revealed that among the domains randomization, allocation secret, masking of participants and personnel, incomplete outcomes, selective outcomes and others, the risk of bias assessed as low ranged from 30.4 to 49.1%; unclear risk between 22 to 56% and high risk from 1 to 21.7%. CONCLUSIONS: The risk of bias in diabetic retinopathy randomized clinical trials exists in high frequency and the reader must be aware of it

A warning to readers about the term metanalysis in non-systematic reviews about diabetic retinopathy: documental study

BACKGROUND: Meta-analysis is a very seductive term in scientific papers because it summarizes a compilation of quantitative results; however its interpretation must be done carefully. OBJECTIVE: Search the diabetic retinopathy intervention literature for the occurrence of the term meta-analysis in non-systematic reviews, showing the reader the frequency that they occur and alert to the dangers that inadequate interpretation can cause. METHODS AND MATERIALS: An extensive search in Pubmed was performed for works with the term meta-analysis in the title, abstract and keywords (ti, abs, kw) without date or language restriction. The selected papers were read fully in search of characteristics of systematic review (SR) or not. The results are presented objectively with a critical analysis of each analysed term. RESULTS: We found 39 papers with the term meta-analysis on (ti, abs, kw). 12 (30.8%) of them did not write the study design in the abstract. 14 (35.9%) did not present the search strategy, 15(38.5%) did not mention having a language or date restriction. 23 (59%) did not mention the SR model that was followed and only five (12.8%) registered the protocol. Only two articles fulfilled the RS requirements. CONCLUSION: We found in the literature reviews of selected studies with meta-analysis, not configuring an SR that can induce the reader to interpret it as an SR. The term meta-analysis cannot be interpreted as the panacea for the solution of all doubts

Bias and unclear outcomes in clinical trials of diabetic retinopathy: a cross-sectional analysis of literature

BACKGROUND: Clinical trials are well-designed papers that aim to answer questions in the real world. However, sometimes they present missing, dubious and unclear outcomes that make it difficult to apply in practice. OBJECTIVE: The objective of this work is to evaluate the way and the frequency with which the outcomes in randomized clinical trials of intervention in diabetic retinopathy can be presented in an unclear way to readers. Make an analysis of how these dubious presentations can lead to misinterpretations, why this happens and how they can be remedied. METHODS AND MATERIALS: We conducted a search for RCT about DR intervention in PubMed published over the past five years. RESULTS: Seventy RCT were included, 27 in peripheral diabetic retinopathy (PDR) and 43 in diabetic macular edema (DME). In the DME group we found 25.6% reporting and publication bias; 34.9% subjective outcomes, 44.1% presented a lack of presentation of the baseline and 51.1% underreporting adverse events. In the PDR group we found 29.6% reporting and publication bias; 44.4% subjective outcomes, 14.8% presented a lack of presentation of the baseline and 62.9% underreporting adverse events. CONCLUSION: In addition to the result bias, we found other forms of publication of unclear outcomes in RCT on DR. Most of them occurred due to disrespect for CONSORT parameters. The reader must be attentive to recognize them and know how they can influence the interpretation of the data

Microangiopathic complications in type 1 diabetes mellitus: differences in severity when isolated or associated with autoimmune polyendocrinopathies

CONTEXT: The development and evolution of different chronic diabetic complications may present variations among the different types and conditions of this disease. OBJECTIVE: To evaluate the degree of microangiopathy in Type 1 diabetes mellitus (DM1) associated with autoimmune polyendocrinopathies (OSAD) or isolated DM1 (iDM1). PATIENTS: OSAD (n=17) and iDM1 (n=13) were over 15 years old at diagnosis of DM and were matched for diabetes duration (13.9 ± 8.2 and 13.2 ± 5.9 years, respectively) and metabolic control (HbA1c: 6.4 ± 1.9 and 6.8 ± 1.4%). MAIN OUTCOME MEASURES: Urinary albumin excretion (UAE; ELISA), the inversion of serum creatinine (1/C) level and indirect ophthalmoscopy. RESULTS: Although the prevalence of hypertension was similar in both groups, the OSAD had inferior levels of UAE (7.4 ± 2.5 vs. 17.3 ± 9.2 µg/min; p< 0.05). Nephropathy was detected in 12% of the OSAD (none of them macroproteinuric) and in 39% of the iDM1 . The UAE in the iDM1 correlated negatively with 1/C values (r= -0.7, p< 0.005), but the same did not occur in the OSAD (r= 0.2, ns). Among patients with retinopathy, the severe form was found in 29% of the OSAD and in 46% of the iDM1. CONCLUSIONS: OSAD was associated with a lower degree of microangiopathy, in spite of age at diagnosis, duration of diabetes and the metabolic control. In contrast with the iDM1 , the increase in UAE of OSAD was not associated with reductions in GFR

FREQUENCY OF OPHTHALMOLOGICAL POSTERIOR SEGMENT FINDINGS IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE

ABSTRACT BACKGROUND: Inflammatory bowel disease is a systemic inflammatory disease classified as Crohn disease or ulcerative colitis. It could present extra intestinal findings, such as fever, weight loss, arthralgia, mucocutaneous lesions, hepatic, renal and ophthalmological involvement. Among ophthalmological findings, posterior segment findings are present in less than 1% of patients with inflammatory bowel disease, however, these findings could bring definitive visual impairment. OBJECTIVE: Our study objective was to evaluate ocular posterior segment findings is patients with inflammatory bowel disease, through retinal mapping, color fundus retinography, optical coherence tomography (OCT) and OCT angiography, and compare our results to literature. METHODS: We evaluated eighty patients with inflammatory bowel disease through complete ophthalmological examination and posterior segment assessment. Color fundus retinography, OCT and OCT angiography was performed with Topcon Triton (Topcon ® , Tokyo, Japan). Macula and posterior pole were evaluated with binocular indirect ophthalmoscopy and fundus biomicroscopy. RESULTS: Participants mean age was 44.16 years (18.08-68.58), 28 (35%) male patients and 52 (65%) female patients. Thirty-five (44%) with diagnosis of Crohn disease, 41 (52%) patients with diagnosis of ulcerative colitis and 3 (4%) had non-conclusive Crohn disease or ulcerative colitis classification. We found abnormal exams in 21 (26.25%) patients. CONCLUSION: Our study found similar prevalence of ophthalmological posterior segment commitment compared to previous literature prevalence. The findings were predominantly unrelated to inflammatory bowel disease, rather than primarily related to it. The most prevalent, and non-previous reported, finding was increased arteriolar tortuosity, probably occurs due to systemic vascular impairment in inflammatory bowel disease