[Introduction of a User-oriented Application for Biometrical Sample Size Calculation in Clinical and Epidemiological Trials]. / Vorstellung eines benutzerfreundlichen Programmes zur biometrischen Fallzahlplanung in klinischen und epidemiologischen Studien.

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). To overcome this gap, a user interface will be illustrated that offers the opportunity of sample size calculation both by means of significance tests and confidence intervals, with intuitive access for clinical researchers. MATERIALS AND METHODS: Estimating sample sizes via confidence intervals requires the predetermination of the interval's maximum width, whereas the calculation of sample sizes via significance test has the minimum requirement of the test's statistical power. The resulting sample size formulas are compatible for all practically relevant cases and mainly differ in the specification of the parameters "width" and "power". For the choice of a suitable statistical power, there are established reference values (usually 80 or 90%), while the calculation of sample size by means of confidence intervals is still difficult for clinical researchers, due to the unavailability of guidelines for the choice of the interval width. The application of both approaches is demonstrated by planning a clinical trial on the rotational stability of toric intraocular lenses with or without an implemented capsular tension ring. RESULTS: A user interface was developed to implement both of the publicly accessible approaches for sample size calculation. The interface allows comparison of the approaches based on significance test and confidence interval and their interchangeability for a two-armed clinical trial design. The operator firstly chooses one of the approaches; then the necessary planning information is inputted and the calculated sample size per trial as well as the corresponding planning information for the other approach are provided. CONCLUSION: The presented sample size tool enables an intuitively accessible way to calculate sample sizes both via significance tests and via confidence intervals for two-armed study designs.

[Do Clinical Trial Publications in AMD Healthcare Provide Sufficient Information on the Underlying Samples' Baseline Characteristics to Enable Generalizability Considerations on the Trial Design?] / Berichten RCT-Publikationen zur Versorgung von AMD-Patienten Baseline-Daten zum eingebrachten Patientengut mit Blick auf die Generalisierbarkeit des Studiendesigns?

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). MATERIALS AND METHODS: A full survey comprised of 132 RCTs (01/2004 - 12/2013). Two parallel independent readers evaluated, and then consented, whether baseline characteristics as recommended were provided in the publication, and whether this information was formally and correctly presented. The evaluation was performed hierarchically in accordance to the sub-criteria of the CONSORT-statement. In the case of formally correct documentation, characteristics for age, gender, the primary clinical endpoint outcome, and the stage of AMD were checked, as well as for systemic or ophthalmological pre-existing conditions. RESULTS: 129 of 132 (98%) publications provided the documentation of baseline data, but only 67 (51%) showed a correct implementation. 77 (58%) RCT reports presented baseline data at study initiation, among which n = 67 (87%) publications presented the data stratified for samples. CONCLUSION: The implementation rate of the CONSORT criterion "baseline data" in publications appeared high. On closer inspection, publications often provided incomplete or even misleading baseline data. As a consequence, everybody in the publication process should be aware of the conditions for publishing.

[An Illustrated Guidance for the Implementation of Methodological CONSORT Criteria in the Transparent Publication of RCTs in Ophthalmology]. / Umsetzungshilfe zu methodischen Kriterien des CONSORT-Statements zur transparenten Publikation von RCTs in der Augenheilkunde.

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. However, it has repeatedly been shown that the implementation of, in particular, the adherence to methodological criteria is a challenge to RCT authors. Therefore, the following overview summarises an illustrated guidance to the minimum necessary information to take into account key methodological items in the CONSORT statement.

[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]. / Einfluss des Impact-Faktors auf das Berichten einer Fallzahlplanung in Publikationen zu Studien am Beispiel der AMD-Therapie : Querschnittuntersuchung zum Vorliegen von Fallzahlplanungen in Publikationen von RCTs zur AMD-Therapie in Zeitschriften mit hohem und niedrigem Impact-Faktor.

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. The primary hypothesis of this investigation compared the prevalence of reported sample size calculations between journals with higher (≥5) versus lower (<5) impact factors (IF). MATERIAL AND METHODS: It was examined whether information on sample size calculation was available in a series of 97 publications of RTCs on AMD treatment published between 2004 and 2014. RESULTS: Only 46 out of 97 (47%) study publications provided information on the reason for the number of patients enrolled. The comparison of publications from journals with an IF ≥ 5 (63%, 30) and from journals with an IF < 5 (40%, 67) showed a statistically significant difference of 23% in the frequencies of available sample size calculations (95% confidence interval, CI 2%; 44%). Of the publications published before 2010, 43% reported a sample size calculation versus 51% of the publications afterwards. CONCLUSION: Publications in journals with higher IF more frequently reported a sample size calculation. More than 50% of the publications did not report any sample size calculation. Authors and reviewers of publications should pay more attention to the explicit reporting of sample size calculations.

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. Method comparison trials in a paired sample study design were identified. Search criteria were 'Icare PRO', 'Rebound', 'Goldmann' and 'Applanation'. Adult patients with glaucoma of any aetiology were included. The intraindividual intraocular pressure deviation between Icare® PRO and Goldmann applanation tonometry (mm Hg) served as primary endpoint, parameterized by the reported mean differences. For each study, an asymptotic 95% confidence interval was derived. The overall intraocular pressure meta-difference (Icare® PRO-Goldmann applanation tonometry) and 95% confidence interval were estimated using the random effect model. RESULT: Of 147 publications, 6 studies (672 eyes) were included after reviewing. Four studies showed an intraocular pressure underestimation by the Icare® PRO, two an overestimation. The meta-difference (Icare® PRO-Goldmann applanation tonometry = -0.14 mm Hg; 95% confidence interval: (-0.43 mm Hg; 0.15 mm Hg)) indicated a non-significant, clinically irrelevant mean deviation (p = 0.335). The devices showed good agreement, but there was a strong heterogeneity between the studies (I² = 77%): two studies presented a significant difference (Icare® PRO-Goldmann applanation tonometry), however, with deviations in opposite directions. CONCLUSION: Although the manufacturer advertises the Icare® PRO as a 'tonometer with superior accuracy', the present review could neither confirm nor deny considerable agreement between Goldmann applanation tonometry and Icare® PRO in glaucomatous patients.

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. Furthermore, the sample size was recalculated, whenever possible based on the published details, in order to verify the reported number of patients. PRIMARY OUTCOME MEASURE: The primary endpoint of this cross-sectional investigation was a described sample size calculation that was reproducible, complete and correct (maximum tolerated deviation between reported and replicated sample size ±2 participants per trial arm). RESULTS: A total of 50 publications (52%) did not provide any information on the justification of the number of patients included. Only 17 publications (18%) provided all the necessary parameters for recalculation; 8 of 97 (8%, 95%-CI: 4% to 16%) publications achieved the primary endpoint. The median relative deviation between reported and recalculated sample sizes was 1%, with a range from -43% to +66%. CONCLUSION: Although a transparent sample size legitimation is a crucial determinant of an RCT's methodological validity, more than half of the RCT publications considered failed to report them. Furthermore, reported sample size legitimations were often incomplete or incorrect. In summary, clinical authors should pay more attention to the transparent reporting of sample size calculation, and clinical journal reviewers may opt to reproduce reported sample size calculations. SYNOPSIS: More than half of the analysed RCT publications on the treatment of AMD did not report a transparent sample size calculation. Only 8% reported a complete and correct sample size calculation.

[Multi-disciplinary anonymous survey on a university hospital's medical doctors' knowledge of established terms and parameters in evidence-based medicine]. / Multidisziplinärer anonymer Survey zur Vertrautheit von Ärztinnen und Ärzten eines Universitätsklinikums mit gängigen Termini und Kenngrößen der evidenzbasierten Medizin.

BACKGROUND: Patient care according to the principles of evidence-based medicine (EbM) is defined by the Social Code (SGB, inter alia §â€Š137f 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. Another question was, at which point of the medical training a possible postgraduate training on EbM methods should take place. MATERIAL AND METHODS: In February 2017, an anonymous survey (paper questionnaire) was conducted at four clinics of the Witten/Herdecke University. The questionnaire offered 12 application scenarios for EbM methods; all items could be clearly answered with "right" or "wrong"; the refusal of an answer to single items was allowed. The investigation's primary endpoint was the individual proportion [%] of correctly among all available answers for each survey participant. The primary analysis sought to estimate this proportion of correct answers by means of a two-sided 95 % confidence interval.Results A total of 70 evaluable questionnaires could be evaluated (15-19 per clinic). The median individual proportion of correct answers was 47 % (95 % CI 40 %; 50 %). The four clinics did not differ significantly with respect to this proportion of correct answers (Kruskal/Wallis p = 0.388) and showed median proportions between 40 % and 50 %. DISCUSSION: Medical practitioners at university hospitals can be expected to have certain knowledge on common methods of clinical research. However, less than 50 % of the answer were correct and a need for further training in EbM-specific methods appears to be indicated. The survey did not provide information on the optimal timing of such offers during medical training.

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. Postoperative evaluation included measurement three months after surgery or prior to an indicated revision surgery. Explorative re-evaluation of the underlying RCT's intent-to-treat population was performed for the entire sample and stratified for cohorts by 95% confidence intervals for binary endpoints' incidences (primary endpoint: absolute postoperative rotation ≤5 degrees; secondary endpoints: absolute deviation between achieved cylinder and target cylinder ≤0.5 dpt, postoperative corrected distance visual acuity (CDVA) ≥ 0.8). Data exploration was based on medians and quartiles. SETTING: Outpatient study sites. DESIGN: Re-evaluation based on data from a multicenter non-inferiority randomized clinical trial (RCT). RESULTS: Sub cohorts (without CTR 89, with CTR 90 patients) did not present clinically relevant differences in preoperative characteristics: revision surgery was performed in 7 cases (3 without and 4 with CTR). Primary endpoint incidences for the total sample, without and with CTR were 90%/89%/90%; cylinder endpoint incidences were 46%/45%/46% and CDVA endpoint incidences 90%/92%/88%. Median absolute rotations were 1.74°/1.79°/1.72°, median absolute cylinder deviations 0.55/0.52/0.55 dpt and median visual acuity 1.0/1.0/1.0. CONCLUSION: No clinically relevant differences between CTR subgroups were found; a satisfying three months rotational stability was achieved. TRIAL REGISTRATION: The trial was registered retrospectively in the trial registry DRKS, trial registration number DRKS00015316 , date of registration 27. August 2018.

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. A standardized questionnaire was used to identify factors associated with eye healthcare utilization, visual impairment and/or blindness. RESULTS: Visual acuity of 566 (94.3%; 413 women and 153 men) of a total of 600 institutionalized elderly was determined. Mean age of the included patients was 82.9 years (± 9.8). Of all participants, 30 (5.3%; 95% CI 3.4-7.2%) were blind and 106 (18.7%; 95% CI 15.5-21.9%) were moderately or severely visually impaired according to the World Health Organization definition. The 136 blind and moderately or severely visually impaired participants were older (OR, Odds Ratio = 1.1, 95% CI 1.0-1.1; p < 0.001), and more likely to have reduced mobility (OR = 12.6, 95% CI 2.8-57.6; p = 0.001). CONCLUSION: A high proportion of blindness and visual impairment was found amongst nursing home residents. Age and reduced mobility were factors associated with an increased likelihood of blindness and visual impairment. Any surveys of blindness and visual impairment excluding nursing homes may considerably underestimate the prevalence of visual impairment and blindness.

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. Data extraction was performed by two parallel readers independently by means of a documentation format in accordance with the 16 items of the CONSORT checklist for abstracts. The total number of criteria fulfilled by an abstract was derived as primary endpoint of the investigation; incidence rate ratios (IRRs) with unadjusted 95% CI were estimated by means of multiple Poisson regression to identify journal and article characteristics (publication year, multicentre design, structured abstract recommendations, effective sample size, effective abstract word counts and journal impact factor) possibly associated with the total number of fulfilled items. STUDY CHARACTERISTICS: 136 of 673 identified abstracts (published in 36 different journals) fulfilled all eligibility criteria. RESULTS: The median number of fulfilled items was 7 (95% CI 7 to 8). No abstract reported all 16 recommended items; the maximum total number was 14, the minimum 3 of 16 items. Multivariate analysis only demonstrated the abstracts' word counts as being significantly associated with a better reporting of abstracts (Poisson regression-based IRR 1.002, 95% CI 1.001 to 1.003). CONCLUSIONS: Reporting quality of RCT abstracts on AMD investigations showed a considerable potential for improvement to meet the CONSORT abstract reporting recommendations. Furthermore, word counts of abstracts were identified as significantly associated with the overall abstract reporting quality.

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. An overall self-rated impairment index (SRI) and sub-indices SRI were calculated on the basis of a modified Visual Quality of Life questionnaire (VQoL), which addresses general vision, glare, near-sight problems and mobility of floaters. SRI ranged from 0 to 100% (maximum impairment). Secondary endpoints included corrected visual acuity and complications. RESULTS: Data were collected prior to and 3 (n = 64) and 12 (n = 62) months after surgery. The median overall SRI improved (44, 12, 11%) with a statistically significant median reduction of 69% (95% confidence interval 50-89%) 3 months postop. The median sub-SRIs improved for glare (50, 17, 17%), near sight problems (50, 17, 8%), and mobility of floaters (43, 5, 0%). Sixteen eyes needed cataract surgery during follow-up (10 showed cataract already prior to vitrectomy). Eight complications were reported (6 intra-operative retinal holes, 2 post-operative retinal detachments). CONCLUSION: For the majority of floater patients, subjective impairment was profoundly reduced by vitrectomy. Benefits of surgery prevailed despite complications.

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. With respect to the foot disorders in our patients (osteoarthritis and prearthritic conditions), we correlated the total range of motion (ROM) in the ankle and subtalar joints as identified by the OFM with values identified during clinical examination 'translated' into score values. Furthermore, reduced walking speed, reduced step length and reduced maximum ankle power generation during push-off were taken into account and correlated to gait abnormalities described in the scores. An analysis of correlations with CIs between the FFI-D and the AOFAS-AHS items and the gait parameters was performed by means of the Jonckheere-Terpstra test; furthermore, exploratory factor analysis was applied to identify common information structures and thereby redundancy in the FFI-D and the AOFAS-AHS items. RESULTS: Objective findings for hindfoot disorders, namely a reduced ROM, in the ankle and subtalar joints, respectively, as well as reduced ankle power generation during push-off, showed a better correlation with the AOFAS-AHS total score-as well as AOFAS-AHS items representing ROM in the ankle, subtalar joints and gait function-compared with the FFI-D score.Factor analysis, however, could not identify FFI-D items consistently related to these three indicator parameters (pain, disability and function) found in the AOFAS-AHS. Furthermore, factor analysis did not support stratification of the FFI-D into two subscales. CONCLUSIONS: The AOFAS-AHS showed a good agreement with objective gait parameters and is therefore better suited to evaluate disability and functional limitations of patients suffering from foot and ankle pathologies compared with the FFI-D.

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 0.148 to 0.8 and quality-adjusted life years (QALY) ranged from 1.424 to 2.43. Based on psychometric instruments such as Euroqol 5 dimensions, utilities ranged from 0.017 to 0.056 and QALY ranged from 0.141 to 0.547. Reported costs per QALY were between $1307 and $14 302. Although the review found consistent favorable cost QALY ratios for cataract surgery according to the British National Institute for Care and Health Excellence threshold, the findings raise doubts about the general applicability of existing studies as a tool for allocation decision. The observed large heterogeneity of the approaches and outcomes for all parameters reflected the complexity of the various evaluation methods and medical care processes and, in some cases, inadequate data.

Multiple endpoints in clinical trials ­ severe adverse event potentials from the medical biometrician's perspective. / Multiple Endpunkte in klinischen Prüfungen Risiken und Nebenwirkungen aus Sicht der Medizinischen Biometrie

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. In most settings, the choice of these endpoints directly arises from the clinical rationale of the investigation, but is then complemented with a rather rigid recommendation from the trial statistician's perspective, that is the restriction to only one primary clinical endpoint. The use of several parallel clinical endpoints cannot only end up in inconsistent or even contradictory clinical decision rules, but can also have crucial impact on the overall number of patients necessary in the statistical analysis of the clinical trial under consideration. Although the combination of multiple parallel endpoints may provide a solution in some clinical trial settings, the most effective recommendation can be seen in specifying only one primary clinical endpoint of maximum clinical relevance for the therapeutic intention at hand.

[Evaluation of the German Research Foundation's (GRF) ¼Clinical Trials Academy for Junior Researchers« - publications and funding profiles]. / Evaluation der DFG-Nachwuchsakademie "Klinische Studien" ­ Publikationen und Folgeförderungen.

Background | The ¼Clinical 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. This evaluation should quantify publication and third-party-funding profiles after participation in one of the previous GRF junior researchers workshops on clinical trials. Methods | Participants of all four GRF workshops were addressed by a standardized questionnaire to consider the project related number of publications and the cumulative impact factor, as well as the cumulative project-related consequential third-party-funding. Results | 64 of 92 former participants took part in the survey. From 41 implemented projects, 32 were granted with initial financial support by the GRF. 27 publications with a cumulative impact factor of 130 impact factor points (IP) were published by 13 authors. Of the 21 persons who submitted a grant application for subsequent third-party-funding a cumulative total grant volume of 5 223 000 € was reported by 13 participants. Conclusion | Although only 13 out of 64 participants reported impact publications or third-party-funding, respectively, these junior researchers' output can be considered encouraging.

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. METHOD: The study was designed as a controlled pre-post intervention study, whereby the intervention consisted in the first notification of the obligation to publish values for clinical quality indicators (QI). The data basis consisted of those QI reported in identical manner from 2006 to 2012 and multivariable statistical analyses were performed. QI from the same clinical area but without reporting obligation in 2006, served as control group. RESULTS: Six QI were included in the intervention group and demonstrated significant quality improvement. The major part of improvements occurred immediately after the intervention. 31 QI were included in the control group, with about 60% showing improvement trends. In comparison, the biggest proportional improvements were registered for publicly reported QI. No significant differences in relation to profit orientation were found. CONCLUSION: Results indicate a positive effect of public reporting on hospital care, independent of a hospital's profit orientation. Improvements in the quality of care were registered for all observed QI over time, but public reporting stimulated an accelerated QI improvement.

[Doctoral thesis projects for medical students? Retrospective estimation of the fraction of successfully completed medical doctoral thesis projects at Witten/Herdecke University]. / Initiierung von Promotionsvorhaben während des Medizinstudiums? Retrospektive Erhebung zum Anteil zeitnah nach Studienende abgeschlossener Promotionsvorhaben zum "Dr. med." an der Universität Witten/Herdecke.

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. As a characteristic efficiency feature of these "Dr med" initiatives, the proportion of doctoral projects successfully completed shortly after graduating from medical school is proposed and illustrated. METHODS: The proposed characteristic can be estimated by the time period between the state examination (date of completion of the qualifying medical examination) and the doctoral examination. Completion of the doctoral project "during their medical studies" was then characterised by a doctoral examination no later than 12 months after the qualifying medical state examination. To illustrate the estimation and interpretation of this characteristic, it was retrospectively estimated on the basis of the full sample of all doctorates successfully completed between July 2009 and June 2012 at the Department of Human Medicine at the Faculty of Health of the University of Witten/Herdecke. RESULTS: During the period of investigation defined, a total number of 56 doctoral examinations were documented, 30 % of which were completed within 12 months after the qualifying medical state examination (95% confidence interval 19 to 44 %). The median duration between state and doctoral examination was 27 months. The proportion of doctoral projects completed parallel to the medical studies increased during the investigation period from 14 % in the first year (July 2009 till June 2010) to 40 % in the third year (July 2011 till June 2012). CONCLUSION: Only about a third of all "Dr med" projects at the Witten/Herdecke Faculty of Health were completed during or close to the qualifying medical studies. This proportion, however, increased after the introduction of a curriculum on research methodology and practice in 2010; prospective longitudinal studies will have to clarify whether this is causal or mere chronological coincidence. In summary, the proposed method for determining the process efficiency of a medical faculty's "Dr med" programme has proven to be both feasible and informative.

Analysis of agreement between the German translation of the American Foot and Ankle Society's Ankle and Hindfoot Scale (AOFAS-AHS) and the Foot Function Index in its validated German translation by Naal et al. (FFI-D).

BACKGROUND: Despite its wide use in clinical outcome measurement, there is yet no validated German language version of the AOFAS-AHS available. After finishing cross-cultural adaption of the AOFAS-AHS according to the AAOS guidelines, an analysis of agreement was carried out. METHODS: This was done by means of the 18-item Foot Function Index in its validated German translation by Naal et al. (FFI-D). The results of 91 orthopedic patients as well as healthy persons in both scores were then compared intraindividually. The cohort consisted of 46 individuals with hindfoot disorders and 45 persons without any hindfoot complaints. The FFI-D-Score was linearly transformed in the range 0-100 points of the AOFAS. RESULTS: Encouraging correlation was then found for the patients with hindfoot disorders (Spearman's correlation 0.73 (95% CI 0.52-0.85); a median deviation of -2 points (interquartile range -13 points; +13 points) in patients with hindfoot disorders implied good median intraindividual score concordance. However, with 30 of these 46 patients showing score deviations beyond or below a pre-specified ±10 points range of clinically tolerable deviations, the scores cannot be considered exchangeable. CONCLUSION: Although the agreement analysis was performed for the German translation of the two questionnaires, analogous results can be expected also for other languages. It should be noted that the results do not allow for judging which of the scores is better suited to give a valid statement on patient outcome in treatment of hindfoot disorders. To verify which of these two scores is better suited to represent hindfoot-dysfunction a subsequent study using instrumental gait analysis and surface EMG is being carried out.

A methodological approach to identify external factors for indicator-based risk adjustment illustrated by a cataract surgery register.

BACKGROUND: Risk adjustment is crucial for comparison of outcome in medical care. Knowledge of the external factors that impact measured outcome but that cannot be influenced by the physician is a prerequisite for this adjustment. To date, a universal and reproducible method for identification of the relevant external factors has not been published. The selection of external factors in current quality assurance programmes is mainly based on expert opinion. We propose and demonstrate a methodology for identification of external factors requiring risk adjustment of outcome indicators and we apply it to a cataract surgery register. METHODS: Defined test criteria to determine the relevance for risk adjustment are "clinical relevance" and "statistical significance". Clinical relevance of the association is presumed when observed success rates of the indicator in the presence and absence of the external factor exceed a pre-specified range of 10%. Statistical significance of the association between the external factor and outcome indicators is assessed by univariate stratification and multivariate logistic regression adjustment.The cataract surgery register was set up as part of a German multi-centre register trial for out-patient cataract surgery in three high-volume surgical sites. A total of 14,924 patient follow-ups have been documented since 2005. Eight external factors potentially relevant for risk adjustment were related to the outcome indicators "refractive accuracy" and "visual rehabilitation" 2-5 weeks after surgery. RESULTS: The clinical relevance criterion confirmed 2 ("refractive accuracy") and 5 ("visual rehabilitation") external factors. The significance criterion was verified in two ways. Univariate and multivariate analyses revealed almost identical external factors: 4 were related to "refractive accuracy" and 7 (6) to "visual rehabilitation". Two ("refractive accuracy") and 5 ("visual rehabilitation") factors conformed to both criteria and were therefore relevant for risk adjustment. CONCLUSION: In a practical application, the proposed method to identify relevant external factors for risk adjustment for comparison of outcome in healthcare proved to be feasible and comprehensive. The method can also be adapted to other quality assurance programmes. However, the cut-off score for clinical relevance needs to be individually assessed when applying the proposed method to other indications or indicators.