Validity of sample sizes in publications of randomised controlled trials on the treatment of age-related macular degeneration: cross-sectional evaluation.

Objective: The aim of this cross-sectional study was to examine the completeness and accuracy of the reporting of sample size calculations in randomised controlled trial (RCT) publications on the treatment of age-related macular degeneration (AMD).

Methods: A sample of 97 RCTs published between 2004 and 2014 was reviewed for the calculation of their sample size. It was examined whether a (complete) description of the sample size calculation was presented.

Meta-analysis of the concordance of Icare PRO-based rebound and Goldmann applanation tonometry in glaucoma patients.

Background: The Icare PRO rebound tonometer is being promoted as a patient-friendly device for glaucoma detection and monitoring, allowing rapid and accurate intraocular pressure measurement avoiding anaesthesia. The aim of this systematic review was to examine the concordance of Icare PRO and Goldmann applanation tonometry in glaucoma patients.

Methods: The German and English literature research was carried out using PubMed and Cochrane Library between January 2010 and March 2018.

[Multi-disciplinary anonymous survey on a university hospital's medical doctors' knowledge of established terms and parameters in evidence-based medicine].

Background: Patient care according to the principles of evidence-based medicine (EbM) is defined by the Social Code (SGB, inter alia § 137f SGB V). As part of quality assurance in medicine, a mandatory further education for doctors is demanded. The aim of this investigation was to evaluate how familiar medical practitioners are with common terms and parameters of EbM.

[Do Clinical Trial Publications in AMD Healthcare Provide Sufficient Information on the Underlying Samples' Baseline Characteristics to Enable Generalizability Considerations on the Trial Design?].

Background: Results of RCTs must enable readers to assess applicability of the presented information into clinical routine. Therefore, the CONSORT statement's item 15 recommends explicit information on (baseline) characteristics for RCT samples. We sought to quantify the adherence to this CONSORT item by evaluation of RCTs on "age-related macular degeneration" (AMD).

Rotation of a toric intraocular lens with and without capsular tension ring: data from a multicenter non-inferiority randomized clinical trial (RCT).

Background: Evaluation of clinical outcome in cohorts with versus without simultaneous implantation of a capsular tension ring (CTR) and a toric lens (Tecnis Toric). Main parameter was rotation referring - in contrast to misalignment - to the IOL axis change from immediately after implantation to the final postoperative position.

Methods: Lens position was measured at baseline with the patient still in recumbent position, postoperative rotation was calculated by software.

[An Illustrated Guidance for the Implementation of Methodological CONSORT Criteria in the Transparent Publication of RCTs in Ophthalmology].

The CONSORT Statement (Consolidated Standards of Reporting Trials) recommends an evidence-based, minimum set of recommendations for the standardised and transparent reporting of randomised clinical trials. This statement includes a checklist of 25 items on regulatory and methodological, as well as characteristics of editorial clinical trial design and results. The recommendations help authors of RCT reports to ensure the complete and transparent reporting of design and result determinants with regard to the standards of evidence-based medicine; furthermore, it seeks to enable readers to critically assess and interpret the presented information and possible limitations of the underlying study data.

[Influence of impact factor on reporting sample size calculations in publications on studies exemplified by AMD treatment : Cross-sectional investigation on the presence of sample size calculations in publications of RCTs on AMD treatment in journals with low and high impact factors].

Background: For scientific and ethical reasons randomized controlled clinical trials (RCTs) should be based on a sample size calculation. The CONSORT statement, an established publication guideline for transparent study reporting, requires a sample size calculation in every study publication.

Objective: The availability of sample size calculations in RCT publications on treatment of age-related macular degeneration (AMD) was investigated.

[Introduction of a User-oriented Application for Biometrical Sample Size Calculation in Clinical and Epidemiological Trials].

Background: Clinical journals strongly recommend the use of confidence intervals to present study results, since these comprise both the statistical significance and the clinical relevance of a study's outcome. However, the mandatory sample size calculations performed during a study's planning stage are mostly reported via significance test-based approaches, as there are currently only a few methods available for planning approaches via confidence intervals. As a result, many articles show a mismatch between the planning (based on significance tests) and result presentation (based on confidence intervals).

Correction to: Visual impairment and blindness in institutionalized elderly in Germany.

The original version of this article inadvertently contained a mistake. Authors incorrectly listed in PDF version while correctly presented in the html version.

Visual impairment and blindness in institutionalized elderly in Germany.

Purpose: To determine the prevalence of and identify factors associated with visual impairment and blindness in institutionalized elderly in Germany.

Methods: In this prospective multicenter cross-sectional study, ophthalmic health care need and provision were investigated in institutionalized elderly in 32 nursing homes in Germany. All participants underwent a standardized examination including medical and ocular history, refraction, visual acuity testing, tonometry, biomicroscopy, and dilated funduscopy.

Multiple endpoints in clinical trials – severe adverse event potentials from the medical biometrician’s perspective.

The clinical evaluation of medicinal drugs follows strict guidelines both concerning the clinical as well as the pharmaceutical implementation perspective. Furthermore, it underlies similarly rigid implementation guidelines from the medical biometry perspective, pertaining from the choice of minimum necessary patient numbers to the primary statistical evaluation concept. The latter, however, require the explicit parameterization of clinical endpoints, alongside which efficacy and effectiveness of the drug under investigation will then be tested for the trial at hand.

Reporting quality of randomised controlled trial abstracts on age-related macular degeneration health care: a cross-sectional quantification of the adherence to CONSORT abstract reporting recommendations.

Objective: To assess the reporting quality of randomised controlled trial (RCT) abstracts on age-related macular degeneration (AMD) healthcare, to evaluate the adherence to the Consolidated Standards of Reporting Trials (CONSORT) statement's recommendations on minimum abstract information and to identify journal characteristics associated with abstract reporting quality.

Design: Cross-sectional evaluation of RCT abstracts on AMD healthcare.

Methods: A PubMed search was implemented to identify RCT abstracts on AMD healthcare published in the English language between January 2004 and December 2013.

23G pars plana vitrectomy for vitreal floaters: prospective assessment of subjective self-reported visual impairment and surgery-related risks during the course of treatment.

Purpose: Quantifying the subjective impairment due to floaters based on an indication-specific questionnaire and setting its change between prior to and 3/12 months after elective vitrectomy in relation to surgical risks.

Methods: Single-arm longitudinal observational multicenter study. Sixty-four floater patients underwent 23G pars plana vitrectomy; simultaneous phacoemulsification was excluded.

Using the Oxford Foot Model to determine the association between objective measures of foot function and results of the AOFAS Ankle-Hindfoot Scale and the Foot Function Index: a prospective gait analysis study in Germany.

Objective: After cross-cultural adaption for the German translation of the Ankle-Hindfoot Scale of the American Orthopaedic Foot and Ankle Society (AOFAS-AHS) and agreement analysis with the Foot Function Index (FFI-D), the following gait analysis study using the Oxford Foot Model (OFM) was carried out to show which of the two scores better correlates with objective gait dysfunction.

Design And Participants: Results of the AOFAS-AHS and FFI-D, as well as data from three-dimensional gait analysis were collected from 20 patients with mild to severe ankle and hindfoot pathologies.Kinematic and kinetic gait data were correlated with the results of the total AOFAS scale and FFI-D as well as the results of those items representing hindfoot function in the AOFAS-AHS assessment.

[Ophthalmological health care of the institutionalized elderly : The OVIS study].

Background: Due to demographic change and societal transformation the number of elderly persons living in retirement homes is growing in Germany. Access to health care is more complicated in the setting of nursing homes. Different regional studies suggest unmet ophthalmological health care needs in institutionalized elderly people.

Results and methodology of cost-utility evaluation of cataract surgery in developed countries: Quality-adjusted life years and cataract.

This review surveyed the results and methods of cost-utility analyses of cataract surgery. Thirteen studies were included. Based on decision-theoretic time trade-off, utilities ranged from 0.

[Evaluation of methodological quality in published RCTs on cataract surgery : Pilot study on the degree of adherence to CONSORT statement requirements and their qualitative validity].

Background: The CONSORT statement can be considered as a guideline to ensure transparency in the reporting of randomized clinical trials (RCT), in addition to specific author instructions and requirements of journals. It provides a total of 25 criteria and 12 additional subcriteria on methodological and regulatorical determinants of clinical trials. The availability of the CONSORT recommendations, however, does not necessarily imply adherence to their obligations and correct realisation of the latter from a methodological perspective, so that even in ophthalmology a lack of transparency in trial reporting cannot be excluded.

[Evaluation of the German Research Foundation's (GRF) »Clinical Trials Academy for Junior Researchers« - publications and funding profiles].

The »Clinical Trials Academy for Junior Researchers« is a strategic funding instrument of the German Research Foundation (GRF). In clinical research, this program responds to an increasing lack of qualified clinician scientists. Application for participation in the workshop is based on a self-proposed academy project; participants can furthermore apply for a GRF grant to implement this academy project.

[Systematic Review of the Application of Complementary and Alternative Medicine and their Potential Therapeutic Benefits in the Treatment of Ophthalmology Patients].

A systematic review was carried out of the reported therapeutic effects of complementary and alternative medicine methods as supplementary or primary treatments for patients suffering from glaucoma, cataract or age-related macular degeneration (AMD). For the years 1990 to 2013, the following databases were screened for reports of the application of complementary and alternative treatments: PubMed, Cochrane Library, EMBASE, CAMbase and AMED. Both randomised and prospective non-randomised patient trials were included in the review; results were evaluated in the following classes: "phytotherapy", "acupuncture/acupressure", "biofeedback" and "other alternative treatments".

Impact of public reporting on the quality of hospital care in Germany: A controlled before-after analysis based on secondary data.

Background: Since 2005 all German hospitals are obliged to publish structured quality reports (QR). International studies suggest that mandatory reporting motivates hospitals to improve the quality of care. We examine whether such an effect can be demonstrated for hospitals in Germany and whether differences exist between for-profit and non-profit hospitals.

[Conception and Content Validation of a Questionnaire Relating to the Potential Need for Information of Visually Impaired Persons with Regard to Services and Contact Persons].

A questionnaire was drafted to identify the needs of visually impaired persons and to optimize their access to non-medical support and services. Subjects had to rate a list of 15 everyday activities that are typically affected by visual impairment (for example, being able to orient themselves in the home environment), by indicating the degree to which they perceive each activity to be affected, using a four-stage scale. They had to evaluate these aspects by means of a relevance assessment.

[Is There Really Agreement between Rebound and Goldmann Applanation Tonometry Methods? Results of a Systematic Review of the Period 01/2005 to 08/2014].

Background: After its introduction in 2003 the iCare® rebound tonometry has gained wide acceptance, mostly as a result of immediate method comparison trials showing high concordance with the Goldmann applanation tonometry (GAT) as a reference method. The objective of this systemic review was the synopsis of the current literature as a rationale of a concordance evaluation between the iCare® rebound and the Goldmann applanation tonometry methods.

Methods: The PubMed database was searched for Anglo-American and German publications comparing intraindividually the two tonometry methods and having been published during the period 01/2005 to 08/2014.

Clinical outcome and cost effectiveness of inpatient rehabilitation after total hip and knee arthroplasty. A multi-centre cohort benchmarking study between nine rehabilitation departments in Rhineland-Palatinate (Western Germany).

Background: Rehabilitation after hip and knee replacement surgery is effective, but cost intensive. To ensure consistent cost-effectiveness across different providers prospective cohort studies on its clinical and economic outcome are recommended. Comparisons alongside suitable outcome quality indicators enable to contrast different providers and--in case of clinically or economically relevant differences--reveal constructive approaches to quality improvement.

[Prospective Reliability Trial to Assess Inter and Intra Observer Reliability of Rebound Tonometry in the Eyes of Healthy Probands].

Purpose: A prospective reliability trial was implemented to estimate the inter- and intraobserver reproducibility of iCare® rebound tonometry in healthy proband eyes.

Material And Methods: Three independent observers performed three replicate measurements, respectively, by means of the iCare®PRO rebound tonometry device in 20 eyes of 20 healthy probands. Two of these observers were medical doctors with an at least two years experience in ophthalmological patient care, the third observer was a study nurse with several years practice in applying ophthalmological diagnostic procedures.

[Doctoral thesis projects for medical students? Retrospective estimation of the fraction of successfully completed medical doctoral thesis projects at Witten/Herdecke University].

Background: The German "Dr med" plays a specific role in doctoral thesis settings since students may start the underlying doctoral project during their studies at medical school. If a Medical Faculty principally encourages this approach, then it should support the students in performing the respective projects as efficiently as possible. Consequently, it must be ensured that students are able to implement and complete a doctoral project in parallel to their studies.