Evidence mapPaperPMID 35867146Full record

ArticleGraefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie2022

SALUS-a non-inferiority trial to compare self-tonometry in glaucoma patients with regular inpatient intraocular pressure controls: study design and set-up.

Kristina Oldiges, Maren Steinmann, Juliane Andrea Duevel, Sebastian Gruhn, Raphael Diener, Martin Dominik Leclaire, Sami Al-Nawaiseh, Nicole Eter, SALUS study group

Registry-linked trialOpen access · hybridAbstract readClinical Trial Protocol
In one paragraph

Article in Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04698876 (SALUS - Selbsttonometrie Und Datentransfer Bei Glaukompatienten Zur Verbesserung Der Versorgungssituation), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.6field-weighted citation impact, top 36% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04698876 nacompletednot on this map

SALUS - Selbsttonometrie Und Datentransfer Bei Glaukompatienten Zur Verbesserung Der Versorgungssituation

TypeinterventionalSponsorUniversity Hospital MuensterRan2021 to 2023Enrolled267ConditionsGlaucoma, Intraocular Pressure, Patient Empowerment, TelemedicineArmsSelf-tonometry by means of ICareHOME, Intraocular measurement by means of rebound tonometry or Goldmann applanation tonometry, Blood pressure
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 2 institutions in 1 country.

Kristina OldigesDepartment of Ophthalmology, University of Muenster Medical Center, Albert-Schweitzer-Campus 1, Building D15, 48149, Muenster, Germany.ORCID http://orcid.org/0000-0001-8538-1276
Maren SteinmannDepartment for Health Economics and Health Care Management, School of Public Health, Bielefeld University, Universitaetsstrasse 25, 33615, Bielefeld, Germany.ORCID http://orcid.org/0000-0003-0350-360X
Juliane Andrea DuevelDepartment for Health Economics and Health Care Management, School of Public Health, Bielefeld University, Universitaetsstrasse 25, 33615, Bielefeld, Germany.ORCID http://orcid.org/0000-0001-5700-4852
Sebastian GruhnDepartment for Health Economics and Health Care Management, School of Public Health, Bielefeld University, Universitaetsstrasse 25, 33615, Bielefeld, Germany.ORCID http://orcid.org/0000-0002-5291-650X
Raphael DienerDepartment of Ophthalmology, University of Muenster Medical Center, Albert-Schweitzer-Campus 1, Building D15, 48149, Muenster, Germany.ORCID http://orcid.org/0000-0002-6778-9857
Martin Dominik LeclaireDepartment of Ophthalmology, University of Muenster Medical Center, Albert-Schweitzer-Campus 1, Building D15, 48149, Muenster, Germany.ORCID http://orcid.org/0000-0001-6571-4117
Sami Al-NawaisehDepartment of Ophthalmology, University of Muenster Medical Center, Albert-Schweitzer-Campus 1, Building D15, 48149, Muenster, Germany.ORCID http://orcid.org/0000-0003-2129-6675
Nicole EterDepartment of Ophthalmology, University of Muenster Medical Center, Albert-Schweitzer-Campus 1, Building D15, 48149, Muenster, Germany. nicole.eter@ukmuenster.de.ORCID http://orcid.org/0000-0001-5617-346X
SALUS study group
Bielefeld University · DEUniversity Hospital Münster · DE

Funding

German Federal Joint Committee (G-BA) 01NVF18002
6 · The paper itself

Abstract

purposeThe SALUS study aims to improve the healthcare situation for glaucoma patients in Germany. In order to detect diurnal intraocular pressure (IOP) fluctuations, inpatient monitoring of IOP in an eye hospital for a minimum of 24 h is the current standard. SALUS assesses the benefits of a new form of outpatient care, where IOP can be measured by the patients themselves at home using a self-tonometer. This approach should promote the patient's health competence and empowerment within the healthcare system while reducing treatment costs.

methodsThe SALUS study is a randomized controlled, open non-inferiority trial, alongside an economic analysis, determining whether outpatient monitoring of IOP with self-tonometry is at least as effective as current standard care and would reduce treatment costs. Participants (n = 1980) will be recruited by local ophthalmologists in the area of Westphalia-Lippe, Germany, and randomized to receive 7-day outpatient or 24-h inpatient monitoring. Participants in both study arms will also receive 24-h blood pressure monitoring. Furthermore, patient data from both study groups will be collected in an electronic case file (ECF), accessible to practitioners, hospitals, and the study participants. The primary endpoint is the percentage of patients with IOP peaks, defined as levels 30% above the patient-specific target pressure. Data will also be collected during initial and final examinations, and at 3, 6, and 9 months after the initial examination.

resultsThe study implementation and trial management are represented below.

conclusionSALUS is a pioneering prospective clinical trial focused on the care of glaucoma patients in Germany. If SALUS is successful, it could improve the healthcare situation and health literacy of the patients through the introduction of various telemedical components. Furthermore, the approach would almost certainly reduce the treatment costs of glaucoma care.

trial registrationClinicalTrials.gov ID: NCT04698876, registration date: 11/25/2020. DRKS-ID: DRKS00023676, registration date: 11/26/2020.

Indexed as

GlaucomaIntraocular PressureEquivalence Trials as TopicHumansInpatientsManometryProspective StudiesRandomized Controlled Trials as TopicReproducibility of ResultsTonometry, OcularData transferGlaucomaIntraocular pressureNon-inferiority trialReading centerSelf-tonometry

Identifiers

PMID35867146
PMCPMC9666328
OpenAlexW4286447752

What Socratic holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.