E-nergEYEze, a vision-specific eHealth intervention based on cognitive behavioral therapy and self-management to reduce fatigue in adults with visual impairment: study protocol for a randomized controlled trial.

BACKGROUND: More than half of the adults with visual impairment experience severe symptoms of fatigue, with a negative impact on daily life. Since there is no evidence-based treatment to reduce fatigue in adults with visual impairment, we developed E-nergEYEze, an eHealth intervention based on cognitive behavioral therapy and self-management tailored to the needs of visually impaired adults. The aim is to describe the study protocol of a randomized controlled trial testing E-nergEYEze. METHODS: A randomized controlled trial will be conducted to investigate the cost-effectiveness and cost-utility of E-nergEYEze to reduce fatigue severity compared to care as usual from a healthcare and societal perspective. A total of 172 severely fatigued adults with visual impairment will be recruited and randomized to either the E-nergEYEze intervention plus care as usual or to care as usual only (ratio 1:1). Inclusion criteria are having a visual impairment, experiencing severe fatigue (Checklist Individual Strength - subscale Fatigue Severity: CIS-FS > 35), being 18 years or older, understanding the Dutch language, and having access to the internet. The intervention consists of one face-to-face session and a computer training followed by internet-based modules with information and assignments on coping with fatigue. During this 5-month intervention, participants will be digitally supported by a social worker. All measurements will be administered at baseline, after 6 and 12 months, and additionally, those related to cost-effectiveness at 3 and 9 months. The primary outcome is fatigue severity (CIS-FS). DISCUSSION: Severe fatigue on top of visual impairment compromises quality of life and is associated with incremental societal costs that largely determine the economic burden of low vision or blindness. E-nergEYEze contributes to the evidence base of potentially feasible interventions to reduce the important health-related consequences of vision loss and could fulfill the gap in knowledge, skills and treatment options for low vision services. TRIAL REGISTRATION: Dutch Trial Register NTR7764 . Registered on 28 May 2019.

Real-World Outcomes of DMEK: A Prospective Dutch registry study.

PURPOSE: This study analyzed real-world practice patterns, graft survival, and outcomes of Descemet membrane endothelial keratoplasty (DMEK) in the Netherlands. DESIGN: Population-based interventional clinical study. METHODS: In this prospective registry study, all consecutive primary DMEK procedures registered in the Netherlands Organ Transplant Registry were identified. Short-term graft survival and outcomes of primary transplants for Fuchs' endothelial dystrophy (FED) were analyzed using Kaplan-Meier survival curves with log-rank test and Cox regression. Linear mixed model analyses were used for best spectacle-corrected visual acuity (BSCVA), spherical equivalent, hyperopic shift, and endothelial cell density. RESULTS: 752 DMEKs were identified between 2011 and 2018. In 90% of cases, the indication for DMEK was FED. Graft survival measured 87% at 3 months, 85% at 6 months, 85% at 1 year, and 78% at 2 years. DMEK procedures after 2015 showed better survival compared to previous years (Hazard ratio = 0.4; P < .001). Baseline BSCVA in primary transplants with FED measured on average 0.45 logarithm of the minimum angle of resolution (logMAR) (95% confidence interval [CI], 0.41-0.49), and significantly improved (overall P < .001) to 0.17 logMAR (95% CI, 0.14-0.21) at 3 months, 0.15 logMAR (95% CI, 0.11-0.18) at 6 months, 0.12 logMAR (95% CI, 0.08-0.16) at 1 year, and 0.08 (95% CI, 0.05-0.12) at 2 years. At 3 months, a hyperopic shift of +0.36 diopters (P < .001) was observed and endothelial cell loss measured 33%. CONCLUSION: Our findings provide real-world support that DMEK is an effective treatment for FED with respect to vision restoration, inducing a small hyperopic shift with an acceptable endothelial cell loss. Graft survival improved over time, suggesting a learning curve on a national level.

Endoscopic subtypes of colorectal laterally spreading tumors (LSTs) and the risk of submucosal invasion: a meta-analysis.

BACKGROUND AND STUDY AIMS: Many studies have reported on laterally spreading tumors (LSTs), but systematic reviews of the data to determine their risk of containing submucosal invasion (SMI) are lacking. We systematically screened and analyzed the available literature to provide a more solid basis for evidence-based treatment. METHODS: We conducted a systematic search in PubMed, Embase, the Cochrane Library, and Scopus for published articles until July 2017. We estimated pooled prevalence or odds ratios (ORs) with 95 % confidence intervals (CIs), using random-effects models. We classified endoscopic subtypes into granular LST, which comprises the homogeneous and nodular mixed subtypes, and non-granular LST, which comprises the flat elevated and pseudodepressed subtypes. RESULTS: We identified 2949 studies, of which 48 were included. Overall, 8.5 % (95 %CI 6.5 % - 10.5 %) of LSTs contained SMI. The risk of SMI differed among the LST subtypes: 31.6 % in non-granular pseudodepressed LSTs (95 %CI 19.8 % - 43.4 %), 10.5 % in granular nodular mixed LSTs (95 %CI 5.9 % - 15.1 %), 4.9 % in non-granular flat elevated LSTs (95 %CI 2.1 % - 7.8 %), and 0.5 % in granular homogenous LSTs (95 %CI 0.1 % - 1.0 %). SMI was more common in distally rather than in proximally located LSTs (OR 2.50, 95 %CI 1.24 - 5.02). The proportion of SMI increased with lesion size (10 - 19 mm, 4.6 %; 20 - 29 mm, 9.2 %; ≥ 30 mm, 16.5 %). The pooled prevalence of patients with one or more LSTs in the general colonoscopy population was 0.8 % (95 %CI 0.6 % - 1.1 %). CONCLUSION: The majority of LSTs are non-invasive at the time of colonoscopic detection and can be treated with (piecemeal) endoscopic mucosal resection. Pretreatment diagnosis of endoscopic subtype, specifying areas of concern (nodule or depression), determines those LSTs at highest risk of containing SMI, where en bloc resection is the preferred therapy.