Reporting quality and adherence of randomized controlled trials about statins and/or fibrates for diabetic retinopathy to the CONSORT checklist

Chen

Journal of Clinical Epidemiology

et al. 2021

Objectives : To assess the reporting quality of abstracts for published randomized controlled trials (RCTs) of interventions for coronavirus disease 2019 (COVID-19), including the use of spin strategies and the level of spin for RCTs with statistically non-significant primary outcomes, and to explore potential predictors for reporting quality and the severity of spin. Study Design and Setting : PubMed was searched to find RCTs that tested interventions for COVID-19, and the reporting quality and spin in the abstracts were assessed. Linear regression analyses were used to identify potential predictors. Results : Forty RCT abstracts were included in our assessment of reporting quality, and a higher word count in the abstract was significantly correlated with higher reporting scores (95% CI 0.044 to 0.658, P=0.026). Multiple spin strategies were identified. Our multivariate analyses showed that geographical origin was associated with severity of spin, with research from non-Asian regions containing fewer spin strategies (95% CI -0.760 to -0.099, P=0.013). Conclusions : The reporting quality of abstracts of RCTs of interventions for COVID-19 is far from satisfactory. A relatively high proportion of the abstracts contained spin, and the findings reported in the results and conclusion sections of these abstracts need to be interpreted with caution.

Section: Discussionmentioning

confidence: 87%

Abstracts for reports of randomized trials of COVID-19 interventions had low quality and high spin

Chen

Journal of Clinical Epidemiology

et al. 2021

“…A search for a safer systemic approach to preventing or delaying development of complications has re-examined the benefits of the lipid-lowering drug fenofibrate ( 223 , 224 ), but the, albeit uncommon, side-effects have also prevented its widespread use. Experience with the liberally prescribed statins has also been examined as a possible means of eliminating the hyperlipidemic risk factor for DR, and there is some evidence from RCT’s ( 225 – 227 ) but a critical analysis of published data suggests that the quality and reporting of the data may be flawed ( 228 ). Experimentally, rosuvastatin has been shown to inhibit leukostasis in which the effect appeared to act on the endothelium rather than the leukocytes, thus pointing to a primary metabolic defect in the endothelium initiating leukostasis ( 145 ).…”

Section: Preventing and Treating The Microvasculopathy Of Obesity/thementioning

confidence: 99%

The Role of Inflammation in Diabetic Retinopathy

2020

Inflammation is central to pathogenic processes in diabetes mellitus and the metabolic syndrome and particularly implicates innate immunity in the development of complications. Inflammation is a primary event in Type 1 diabetes where infectious (viral) and/or autoimmune processes initiate disease; in contrast, chronic inflammation is typical in Type 2 diabetes and is considered a sequel to increasing insulin resistance and disturbed glucose metabolism. Diabetic retinopathy (DR) is perceived as a vascular and neurodegenerative disease which occurs after some years of poorly controlled diabetes. However, many of the clinical features of DR are late events and reflect the nature of the retinal architecture and its cellular composition. Retinal microvascular disease is, in fact, an early event pathogenetically, induced by low grade, persistent leukocyte activation which causes repeated episodes of capillary occlusion and, progressive, attritional retinal ischemia. The later, overt clinical signs of DR are a consequence of the retinal ischemia. Metabolic dysregulation involving both lipid and glucose metabolism may lead to leukocyte activation. On a molecular level, we have shown that macrophage-restricted protein tyrosine phosphatase 1B (PTP1B) is a key regulator of inflammation in the metabolic syndrome involving insulin resistance and it is possible that PTP1B dysregulation may underlie retinal microvascular disease. We have also shown that adherent CCR5 + CD11b + monocyte macrophages appear to be selectively involved in retinal microvascular occlusion. In this review, we discuss the relationship between early leukocyte activation and the later features of DR, common pathogenetic processes between diabetic microvascular disease and other vascular retinopathies, the mechanisms whereby leukocyte activation is induced in hyperglycemia and dyslipidemia, the signaling mechanisms involved in diabetic microvascular disease, and possible interventions which may prevent these retinopathies. We also address a possible role for adaptive immunity in DR. Although significant improvements in treatment of DR have been made with intravitreal anti-VEGF therapy, a sizeable proportion of patients, particularly with sight-threatening macular edema, fail to respond. Alternative therapies targeting inflammatory processes may offer an advantage.

“…This study aimed to show how the resulting bias and other dubious presentations of outcomes can appear in RCT on DR and alert readers to read the articles with more criteria. Many of these biases have already been reported in the literature 32 and could be corrected with strict compliance with CONSORT rules. 17 We observed the persistence of a lack of standardization in assessing outcomes, which makes it challenging to carry out systematic reviews.…”

Section: Lack Of Relevance To Patients and Decision-makers Occurs When The Laboratory Markers Do Not Presentmentioning

confidence: 90%

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

Mozetic

Denadai

Cruz³

et al. 2022

Evidence

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.