scholarly journals Transepithelial versus epithelium-off corneal collagen cross-linking for corneal ectasia: protocol for a systematic review, meta-analysis and trial sequential analysis of randomised controlled trials

BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e025728 ◽  
Author(s):  
Siddharth Nath ◽  
Carl Shen ◽  
Alex Koziarz ◽  
Laura Banfield ◽  
Mark A Fava ◽  
...  

IntroductionCorneal ectasias are progressive, degenerative ocular diseases defined by abnormal structural changes in the cornea, leading to distortion of vision and substantial reduction in quality of life. Corneal collagen cross-linking (CXL) increases the biomechanical rigidity of the cornea and has been shown to halt ectatic processes. The established CXL protocol requires removal of the corneal epithelium. However, some surgeons have proposed transepithelial approaches to enhance patient recovery and minimise adverse events. Whether novel transepithelial approaches are as effective in arresting ectasia as the established epithelium-off protocol remains unclear. This study will systematically review the evidence on transepithelial CXL approaches and compare it to the epithelium-off protocol.Methods and analysisWe will include randomised controlled trials (RCTs) comparing transepithelial and epithelium-off CXL for any corneal ectasia. We will search 16 electronic databases including MEDLINE and Embase, as well as the grey literature. Two reviewers will independently screen search results to identify eligible studies, complete data abstraction and conduct quality assessment. We will assess the quality of individual RCTs using the Cochrane risk of bias assessment tool. Our primary outcome will be the change in maximal keratometry at 12 months after treatment, and we will examine 11 additional outcomes. We will summarise our analyses by measures of association (relative risk or odds ratio) and corresponding 95% confidence intervals (CIs) for dichotomous outcomes and weighted mean differences with 95% CIs for continuous outcomes. Prespecified subgroup analyses will be conducted to explore heterogeneity. The overall quality of evidence will be rated using the Grading of Recommendations Assessment, Development and Evaluation approach.Ethics and disseminationEthics approval is not required for this systematic review as it draws from previously published data. Results of the study will be submitted to a peer-reviewed journal for publication and discussed at conferences and seminars.PROSPERO registration numberCRD42018102069

BMJ Open ◽  
2018 ◽  
Vol 8 (1) ◽  
pp. e019291 ◽  
Author(s):  
Shenghan Lou ◽  
Houchen Lv ◽  
Zhirui Li ◽  
Peifu Tang ◽  
Yansong Wang

IntroductionFracture healing is a complex physiological process. Impaired healing will increase the need for care and cause serious complications. Thus, identifying strategies to accelerate the rate of healing, preventing delayed unions and non-unions, is essential. Parathyroid hormone (PTH) is a key systemic regulator of calcium and phosphate metabolism. It has been determined that intermittent administration of PTH and its analogue can exert anabolic effect on bone, increase bone mass and reduce bone loss, leading to an increase in bone formation. Owing to their anabolic effect, there is an increasing interest in its potential in promoting the process of fracture healing. However, in clinical studies, the results are in conflict. This objective of this study is to determine the role of PTH analogues for fracture healing in adults.Methods and analysisMEDLINE, EMBASE and Cochrane databases will be searched to identify all randomised controlled trials (RCTs) and quasi-RCTs that compare the different effects between PTH analogues and any other treatments in adults with any type of fracture. The primary outcome is the functional recovery. And the secondary outcomes are fracture union and adverse events. The meta-analysis will be performed using a random effects model. Heterogeneity will be assessed by the P values and I² statistic. And subgroup analyses and sensitivity analyses will be used to explore the heterogeneity. Risk of bias will be assessed using the Cochrane tool and the quality of evidence will be assessed using the Grading of Recommendations Assessment, Development and Evaluation approach.Ethics and disseminationEthical approval is not required because this proposed systematic review and meta-analysis is based on published data, without including confidential personal data or data on interventions on patients. The findings of this study will be published in a peer-reviewed journaland presented at a relevant conference.PROSPERO registration numberCRD42017062093.


Burns ◽  
2009 ◽  
Vol 35 (7) ◽  
pp. 956-961 ◽  
Author(s):  
Stefan Danilla ◽  
Jason Wasiak ◽  
Susana Searle ◽  
Cristian Arriagada ◽  
Cesar Pedreros ◽  
...  

2013 ◽  
Vol 22 (4) ◽  
pp. 417-424 ◽  
Author(s):  
Chara Ntala ◽  
Panagiota Birmpili ◽  
Allison Worth ◽  
Niall H Anderson ◽  
Aziz Sheikh

2019 ◽  
pp. bmjspcare-2019-001902
Author(s):  
Francesco Sparano ◽  
Neil K Aaronson ◽  
Mirjam A G Sprangers ◽  
Peter Fayers ◽  
Andrea Pusic ◽  
...  

ObjectivesInclusion of patient-reported outcomes (PROs) in cancer randomised controlled trials (RCTs) may be particularly important for older patients. The objectives of this systematic review were to quantify the frequency with which older patients are included in RCTs with PROs and to evaluate the quality of PRO reporting in those trials.MethodsAll RCTs with PRO endpoints, published between January 2004 and February 2019, which included a patient sample with a mean/median age ≥70 years, were considered for this systematic review. The following cancer malignancies were considered: breast, colorectal, lung, prostate, gynaecological and bladder cancer.Quality of PRO reporting was evaluated using the International Society for Quality of Life Research–PRO standards. Studies meeting at least two-thirds of these criteria were considered to have high-quality PRO reporting.ResultsOf 649 RCTs identified with a PRO endpoint, only 72 (11.1%) included older patients. Of these, 35 trials (48.6%) were conducted in patients with metastatic/advanced disease. PROs were primary endpoints in 20 RCTs (27.8%). Overall survival was the most frequently reported clinical outcome in studies of patients with metastatic/advanced cancer (n=28, 80%). One-third of the RCTs (n=24, 33.3%) were considered to have high-quality PRO reporting. Overall, the largest prevalence of RCTs with high-quality PRO reporting was observed in prostate and colorectal cancers.ConclusionsOur review indicates not only that PRO–RCT-based studies in oncology rarely include older patients but also that completeness of PRO reporting of many of them is often suboptimal.


Sign in / Sign up

Export Citation Format

Share Document