Protocol for an economic evaluation of a tele-neurologic intervention alongside a stepped wedge randomised controlled trial (NeTKoH).

BACKGROUND: A significant and growing portion of the global burden of diseases is caused by neurological disorders. Tele-neurology has the potential to improve access to health care services and the quality of care, particularly in rural and underserved areas. The economic evaluation of the stepped wedge randomised controlled trial NeTKoH aims to ascertain the cost-effectiveness and cost-utility regarding the effects of a tele-neurologic intervention in primary care in a rural area in Germany. METHODS: This protocol outlines the methods used when conducting the trial-based economic evaluation of NeTKoH. The outcomes used in our economic analysis are all prespecified endpoints of the NeTKoH trial. Outcomes considered for the cost-utility and cost-effectiveness analyses will be quality-adjusted life years (QALYs) derived from the EQ-5D-5L, proportion of neurologic problems being solved at the GP's office (primary outcome), hospital length-of-stay and number of hospital stays. Costs will be prospectively collected during the trial by the participating statutory health insurances, and will be analysed from a statutory health insurance perspective within the German health care system. This economic evaluation will be reported complying with the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist. DISCUSSION: This within-trial economic evaluation relaying the costs and outcomes of an interdisciplinary tele-consulting intervention will provide high-quality evidence for cost-effectiveness and policy implications of a tele-neurological programme, including the potential for application in other rural areas in Germany or other jurisdictions with a comparable health system. TRIAL REGISTRATION: German Clinical Trials Register (DRKS00024492), date registered: September 28, 2021.

Effect evaluation of a tele-neurologic intervention in primary care in a rural area in Germany-the NeTKoH study protocol of a stepped-wedge cluster randomized trial.

BACKGROUND: Neurological disorders account for a large and increasing proportion of the global burden of disease. Therefore, it is important to strengthen the management of neurologic care, particularly in rural areas. The use of tele-neurology in primary care in rural areas is internationally considered to have the potential to increase access to health care services and improve the quality of care in these underserved areas. NeTKoH aims to address the existing knowledge gap regarding the effects of a tele-neurologic intervention in primary care under real-world conditions in a rural area in Germany. METHODS: NeTKoH is a cluster-randomized controlled trial with a stepped-wedge design involving 33 outpatient general practitioner's (GP) offices (clusters) in a rural area in Northeast Germany. During 11 predetermined steps, all clusters are randomized before they cross over into groups from the control to the intervention arm. The targeted sample size is 1,089 patients with neurologic symptoms that are continuously being recruited. In the intervention arm, tele-neurologic consultations will be provided via a face-to-face video conferencing system with a neurologic expert at a university hospital. The control arm will receive usual care. The primary outcome is the proportion of neurologic problems being solved at the GP's office. Secondary outcomes will comprise hospital stays and days, time until neurologic specialist appointments and diagnostics, patients' health status and quality of life, outpatient and inpatient referrals. A concurrent observational study, together with a process, implementation, and health economic evaluation, will also be conducted. DISCUSSION: Using a stepped-wedge cluster design in a real-life situation can help with logistic challenges and enhance the motivation of the participating GPs, as all, at some point, will be in the intervention phase. With the additional implementation evaluation pertaining to external validity, an observational study, and a health economic evaluation, NeTKoH will be able to provide an extensive evaluation for health policy decision-makers regarding the uptake into standard care. TRIAL REGISTRATION: German Clinical Trials Register (DRKS00024492). Date registered: September 28, 2021. Date and protocol version: June 2023, version 1.

Clinical Outcomes of Micropulse Transscleral Cyclophotocoagulation: 2 Years of Experience in Portuguese Eyes.

Aim: This study evaluates the safety and efficacy of micropulse transscleral cyclophotocoagulation (MPTSCPC) in glaucoma patients, with standard parameters, over a 24-month period. Methods: Retrospective analysis of 61 eyes undergoing MPTSCPC from January 2018 to December 2020 was carried out. Patients received 160 seconds of laser, with settings of 2000 mW/cm2 and a duty cycle of 31.3%. Results: A total of 61 eyes were included, arranged in an age distribution of 73.9 ± 10.8 years. The most frequent diagnosis was primary open-angle glaucoma (POAG), with a mean best-corrected visual acuity (BCVA) of 5/10 in the Snellen Visual chart. Around 37.7% of the eyes had undergone at least one glaucoma filtration surgery prior to MPTSCPC. The mean pretreatment intraocular pressure (IOP) was 24.9 ± 8.6 mm Hg. Except for the contrast at 24 months, at every other follow-up visit, there was a significant reduction (p ≤ 0.001) in IOP and in the number of topical drugs required to control IOP, from four (baseline) to three, with oral acetazolamide suspension in most cases. The total success rate (absolute and clinical successes combined) was 81.9% after 1 year of the treatment. There was no drop in visual acuity or cases of serious complications. There is a positive and significant correlation between prior glaucoma surgery and the need for reinterventions (p = 0.028). Conclusions: Micropulse transscleral cyclophotocoagulation (MPTSCPC) is an effective and safe procedure for reducing IOP within a broad spectrum of glaucoma patients. Additional studies are needed to confirm the current indications, widen their scope, and determine the optimal treatment settings on an individual basis. How to cite this article: Basto RC, Almeida J, Roque JN, et al. Clinical Outcomes of Micropulse Transscleral Cyclophotocoagulation: 2 Years of Experience in Portuguese Eyes. J Curr Glaucoma Pract 2023;17(1):30-36.