[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]. / Bewertung der methodischen Qualität publizierter RCTs in der Kataraktchirurgie : Pilotstudie zur quantitativen Zielerfüllung bestehender Anforderungen laut CONSORT-Statement und deren qualitative Validierung.

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. OBJECTIVE: The question was whether a consistent consideration of the CONSORT checklist criteria by authors actually implied transparent reporting of underlying study results. MATERIALS AND METHODS: This pilot study was based on a random sample of six published RCTs on cataract surgery extracted from an existing trial publication register. Compliance with each of the 25 CONSORT criteria and its 12 subcriteria and the content accuracy of the latter were independently assessed by two parallel raters for the six trial publications. RESULTS: The median compliance with the 37 CONSORT criteria and subcriteria was 62% [min-max 48-81%]; the median fraction of their correct implementation was 47% [min-max 34-69%]. CONCLUSIONS: Promotion of transparent reporting by means of the CONSORT statement appears to be problematic in implementation. There is a discrepancy between information as required by CONSORT and the content accuracy of its actual presentation. Thus, in particular, reviewers of clinical trial publications should not only check for the presence of data to be provided according to CONSORT, but also verify the meaningfulness in the respective context, at least on a random basis.

[Ophthalmological health care of the institutionalized elderly : The OVIS study]. / Ophthalmologische Versorgung in Seniorenheimen : Die OVIS-Studie.

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. This study assessed the current ophthalmological health care structure and supply status in nursing homes in Germany. METHODS: This prospective, multicenter cross-sectional study was conducted by 14 study centers in Germany. Elderly people living in 32 nursing homes were included after approval by the local institutional review boards. A standardized examination was performed which included a detailed medical and ocular history, refraction, visual acuity testing, tonometry, biomicroscopy and dilated funduscopy. Unmet ophthalmological health care needs were documented and the data were analyzed descriptively and via logistic regression modelling. RESULTS: A total of 600 participants (434 women and 166 men) aged 50-104 years were examined of which 368 (61%) had ophthalmological conditions requiring treatment. The most prevalent findings were cataracts (315; 53%), disorders of the eyelids (127; 21%), dry eye disease (57; 10%) and posterior capsule opacification (43; 7%). In 63 (11%) of the participants glaucoma was suspected and 55 (9%) of the examined population had a known diagnosis of glaucoma, of whom one third was not on any or on insufficient anti-glaucomatous therapy. 236 (39%) showed signs of age-related macular degeneration (AMD). Only 52% of the examined cohort had been examined by an ophthalmologist within the last 5 years and 39% stated that they would currently not be able to consult an ophthalmologist. Reported barriers were mainly transport and lack of support. CONCLUSION: This study demonstrates considerable unmet ophthalmological health care needs of the institutionalized elderly in Germany. Novel and reformed models of specialist care provision have to be developed.

[Systematic Review of the Application of Complementary and Alternative Medicine and their Potential Therapeutic Benefits in the Treatment of Ophthalmology Patients]. / Ergebnisse eines systematischen Reviews zu Einsatz und berichtetem therapeutischem Nutzen komplementärmedizinischer Methoden in der Augenheilkunde.

Purpose 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). Material and Methods 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". The studies were evaluated by measures of clinical effect, statistical significance (p value and/or confidence interval) and the underlying trial design. Results 30 clinical trials were included, including 13 on glaucoma, 5 on cataract and 12 on AMD patients. These trials were based on patient numbers of 6 - 332, 27 - 157 and 6 - 328 patients, respectively. Phytotherapy was applied in 14 trials, including 6 on glaucoma patients (all 6 with a controlled design, and 3 of which reporting statistically significant results); 5 trials were on cataract patients (3 with a controlled design and 2 with a significant result) and 3 on AMD patients (only 1 with a controlled design, with a significant result). Acupuncture/acupressure was investigated in 9 trials, 5 on glaucoma patients (3 with a controlled design, 1 with a significant result); no acupuncture/acupressure trial was found in cataract patients, but 4 trials in AMD patients (none with a controlled design). Biofeedback was studied in 4 trials, all on AMD patients (only one with a controlled design, without statistically significant findings). Conclusion Despite its rigorous inclusion criteria, this review identified several clinical trials on complementary and alternative medicine in ophthalmological patients. Phytotherapeutic methods gave significant results in half of the reported controlled trials, whereas there were few significant benefits with acupuncture or acupressure.

[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]. / Konzeption und Inhaltsvalidierung eines Fragebogens zu Informationsbedürfnissen bezüglich Dienstleistungen und Ansprechpartnern von sehbehinderten Menschen (FIDAS).

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. The needs profile derived from this is then correlated with individualized information for assistance and support. The questionnaire shall be made available for use by subjects through advisers in some ophthalmic practices and via the internet. The validity of the content of the proposed tool was evaluated on the basis of a survey of 59 experts in the fields of medical, optical and psychological care and of persons involved in training initiatives. The experts were asked to rate the activities by relevance and clarity of the wording and to propose methods to further develop and optimize the content. The validity of the content was quantified according to a process adopted in the literature, based on the parameters Interrater Agreement (IRA) and Content Validity Index (CVI). The results of all responses (n = 19) and the sub-group analysis suggest that the questionnaire adequately reflects the potential needs profile of visually impaired persons. Overall, there was at least 80% agreement among the 19 experts for 93% of the proposed parameterisation of the activities relating to the relevance and clarity of the wording. Individual proposals for optimization of the design of the questionnaire were adopted.

[Is There Really Agreement between Rebound and Goldmann Applanation Tonometry Methods? Results of a Systematic Review of the Period 01/2005 to 08/2014]. / Wirklich gute Übereinstimmung zwischen Rebound- und Goldmann-Applanationstonometrie? Ergebnisse eines Systematic Review zum Zeitraum 01/2005 bis 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. The primary endpoint of the review was the reported IOD deviation [mmHg] between the two devices; for each trial, this primary endpoint was parameterised in terms of the "mean deviation" as well as the "relative frequency [%] of measurements with an intraindividual deviation of ≥ ±â€Š3 mmHg". A total of 33 published method comparison studies concerning the iCare TA01i device were included, 17 of them being published between 01/2009 and 08/2014. The number of analysed eyes ranged between 28 and 445; 17 of the 33 studies reported more than 100 examined eyes. 7 of the 33 studies included only healthy eyes. RESULTS: Only 10 out of the 33 studies reported a mean deviation of more than ± 1.5 mmHg, 7 of these were published between 01/2009 and 08/2014. Only 12 of the 33 studies reported the relative frequency of intraindividual deviations ≥ ±â€Š3 mmHg, 7 of them reporting a frequency > 20 % (with a maximum of 51 %), with higher frequencies being derived from samples showing higher IOD levels according to the GAT reference. CONCLUSION: As concluded from the current literature the iCare® rebound and the Goldmann applanation tonometry methods cannot be considered exchangable.

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. AIM: Therefore an external benchmarking for posthospital curative treatment after hip and knee arthroplasty between nine inpatient rehabilitation departments in the German Federal Land Rhineland-Palatinate was implemented based on data acquired between 01/2007 and 12/2009. DESIGN: Multi-centre retrospective cohort benchmarking study. SETTING: Inpatient rehabilitation in nine rehabilitation departments POPULATION: A total of 8672 patients after unilateral hip arthroplasty (THA) and 8180 patients after unilateral knee replacement (TKA) surgery were investigated. The median age of the patients after hip arthroplasty varied between 71 and 75 years, after knee arthroplasty between 72 and 75 years. The department-wise proportions of female patients ranged from 62% to 77% (THA) and from 70% to 81% (TKA). METHODS: Data on clinical outcome of inpatient rehabilitation after THA and TKA were documented using the EVAReha® software. As primary indicator of clinical outcome quality the intra-individual pre-post change in the total Staffelstein Index was determined [%], as primary economic indicator the cost-normalized effect estimate (CNEE) was estimated [%/€] relating the individual Staffelstein Index change to a patient's respective direct costs [€] paid by the statutory health insurance. RESULTS: In the nine departments the median Staffelstein index increase after THA ranged between 18% to 31% corresponding to median CNEEs ranging from 9% to 15% Staffelstein increase per €1000 investment of the statutory health (Kruskal/Wallis P<0.001). After TKA the median Staffelstein index increase ranged between 19% to 34% corresponding to median CNEEs ranging from 9% to 16% Staffelstein increase per 1,000 € investment of the statutory health (Kruskal / Wallis P<0.001). CONCLUSION: Inpatient follow-up treatment after hip and after knee replacement surgery demonstrated a statistically significant and both clinically and economically relevant heterogeneity between the departments. Additional exploratory analyses by means of adjustment with further predictors could not resolve these heterogeneities. CLINICAL REHABILITATION IMPACT: Benchmark information on cost effectiveness would enable departments to learn from the "best" and to implement corresponding peer cooperation, to then identify own shortcomings and potentials, and thereby to analyze and optimize local processes.

[Prospective Reliability Trial to Assess Inter and Intra Observer Reliability of Rebound Tonometry in the Eyes of Healthy Probands]. / Prospektive Reproduzierbarkeitsstudie zur Inter- und Intraobserver-Reliabilität der Rebound-Tonometrie an augengesunden Probanden.

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. Each observer's replicate measurements were averaged and then compared by means of a global Friedman test for interobserver bias in the parallel rebound tonometry measurements at the 5 % significance level. In addition, variance component analysis was performed on the overall repeated measurement design to estimate the iCare® reliability coefficient [%] (100 % indicating total reproducibility in absence of any inter or intra observer bias). RESULTS: The respective observers' median average measurements were 15.9 mmHg (interquartile range 15.1 to 17.5 mmHg) and 15.1 mmHg (14.3 to 15.6 mmHg) for the medical doctors, furthermore 16.8 mmHg (14.2 to 18.9 mmHg) for the study nurse; the averaged measurement series showed a significant interobserver bias (Friedman p = 0.006). Variance component analysis revealed an overall iCare® reliability of 35 % (95 % confidence interval 26 to 44 %). CONCLUSION: In this repeated measurement design iCare® rebound tonometry measurements showed significant interobserver bias and thereby notably reduced overall reliability. In particular, the intraindividual measurement profiles showed a gradient towards smaller values during the 9 replicates' series; furthermore the study nurses' measurements showed notably increased variability. As a consequence the routine use of iCare® rebound tonometry must be critically discussed at least when being delegated to less experienced staff.

[Case control trial on putative factors antagonising the successful project course of MD thesis projects]. / Fall-Kontroll-Studie zur Identifikation von Mechanismen mit der Konsequenz des Abbruchs eines Promotionsvorhabens zum "Dr. med."

INTRODUCTION: Award of the degree MD has special relevance in Germany since the underlying research project can be started during the qualification for admission to doctoral training. This leads to a large number of thesis projects with a not always sufficiently pronounced enthusiasm and thus poor chances of success. Accordingly a case control study was undertaken in the Department of Human Medicine, Witten/Herdecke University to investigate reported drop-outs of thesis projects. MATERIAL AND METHOD: In autumn 2012 all students in the clinical phases of human medicine education were surveyed using a self-conceived questionnaire on previously initiated or terminated thesis projects, "terminated" is defined as the unsuccessful ending of a project after working for at least 3 months. Individually reported thesis terminations were evaluated using defined items in a 4-stage Likert scale regarding thesis plan and project, subsequently, graduate students who successfully completed a project received the same questionnaire. The items possibly corresponding to process determinants were averaged to a total of 7 dimensions prior to the analysis; the resulting scores were normalised in value ranges 0.0 to 1.0 (1.0 = optimal project situation) whereby individual items could be included in several scores. By means of 5 items a primary endpoint from the faculty's perspective on "compliance with formal procedures" was aggregated; by means of a two-sided Wilcoxon test at the 5 % level students with unsuccessful and successful courses were compared along the corresponding scores. RESULTS: 181 of 276 students from 7 study semesters participated in the screening; details of 17 terminations and 23 currently successful courses could be evaluated in the case control study. For significant differences (p < 0.001) between unsuccessful and successful courses in the primary endpoint, median scores of 0.17 (0.07-0.50) versus 0.73 (0.53-0.83) were estimated. CONCLUSION: There were differences between unsuccessful and (as yet) successful courses, especially with regard to the aspects "compliance with formal procedures". Thus a recommendation can be derived in the sense of a stricter and, if necessary, sanctioning demand for formal procedures such as early reporting of thesis projects to the responsible committees. A weakness is the low number of evaluable self-reported drop-outs as well as the overall moderate response rate.

[Case numbers and revenues of main and affiliated ophthalmological departments: Developments since 2005]. / Fallzahlen und Erlöse in ophthalmologischen Haupt- und Belegabteilungen : Entwicklungen seit 2005.

BACKGROUND: Currently, very little data exist on the development of healthcare-related and financial parameters of both types of inpatient treatment: clinical units run by affiliated physicians and those run by hospital physicians. AIM: This study used a methodology based on published secondary data to estimate the annual number of cases and revenues for in inpatient ophthalmological treatment differentiated into clinical units run by affiliated physicians and those run by hospital physicians. MATERIAL AND METHODS: The case-based flat-rate catalogs and accompanying research data published annually by the Institute for the Hospital Remuneration System (Institut für Entgeltsysteme im Krankenhaus, InEK) served as a data source. The numbers of annual cases according to major diagnostic categories (MDC) and diagnosis-related groups (DRG), stratified by the unit type are reported for the period 2005-2012. The cumulative total revenues were calculated based on the number of ophthalmological cases, the effective DRG cost weighting, the length of stay and the national basic case values. RESULTS: Between 2005 and 2012 the units run by affiliated physicians showed a contrasting trend to those run by hospital physicians: the number of cases in units run by hospital physicians increased by 14 %, while those in units run by affiliated physicians decreased by 6 %. Up to 2012 the effective cost weighting for cases in units run by hospital physicians decreased to 0.60 (- 3 %) and increased to 0.43 (+ 5 %) for units run by affiliated physicians. In 2012 the corresponding effective case revenue accounted for 1767 euros and 1271 euros, respectively. Total revenue estimates for all inpatient ophthalmological treatment increased from 549 million euros in 2005 to 630 million euros in 2012, while the share of units run by affiliated physicians amounted to 10.6 % and 9.7 %, respectively. CONCLUSION: According to the indicators "number of cases" and "total revenue", the affiliated ophthalmologists lost ground compared with inpatient units run by hospital physicians over the period from 2005-2012.

[German Total Ankle Replacement Register of the German Foot and Ankle Society (D. A. F.) - presentation of design and reliability of the data as well as first results]. / Deutsches Register für Endoprothesen des oberen Sprunggelenks der Deutschen Assoziation für Fuß und Sprunggelenk e. V. - Design, Datenbelastbarkeit sowie Darstellung der 2½-Jahres-Ergebnisse.

INTRODUCTION: Even though arthroplasty of the ankle joint is considered to be an established procedure, only about 1,300 endoprostheses are implanted in Germany annually. Arthrodeses of the ankle joint are performed almost three times more often. This may be due to the availability of the procedure - more than twice as many providers perform arthrodesis - as well as the postulated high frequency of revision procedures of arthroplasties in the literature. In those publications, however, there is often no clear differentiation between revision surgery with exchange of components, subsequent interventions due to complications and subsequent surgery not associated with complications. The German Orthopaedic Foot and Ankle Association's (D. A. F.) registry for total ankle replacement collects data pertaining to perioperative complications as well as cause, nature and extent of the subsequent interventions, and postoperative patient satisfaction. MATERIAL AND METHODS: The D. A. F.'s total ankle replacement register is a nation-wide, voluntary registry. After giving written informed consent, the patients can be added to the database by participating providers. Data are collected during hospital stay for surgical treatment, during routine follow-up inspections and in the context of revision surgery. The information can be submitted in paper-based or online formats. The survey instruments are available as minimum data sets or scientific questionnaires which include patient-reported outcome measures (PROMs). The pseudonymous clinical data are collected and evaluated at the Institute for Evaluative Research in Medicine, University of Bern/Switzerland (IEFM). The patient-related data remain on the register's module server in North Rhine-Westphalia, Germany. The registry's methodology as well as the results of the revisions and patient satisfaction for 115 patients with a two year follow-up period are presented. Statistical analyses are performed with SAS™ (Version 9.4, SAS Institute, Inc., Cary, NC, USA). RESULTS: About 2½ years after the register was launched there are 621 datasets on primary implantations, 1,427 on follow-ups and 121 records on re-operation available. 49 % of the patients received their implants due to post-traumatic osteoarthritis, 27 % because of a primary osteoarthritis and 15 % of patients suffered from a rheumatic disease. More than 90 % of the primary interventions proceeded without complications. Subsequent interventions were recorded for 84 patients, which corresponds to a rate of 13.5 % with respect to the primary implantations. It should be noted that these secondary procedures also include two-stage procedures not due to a complication. "True revisions" are interventions with exchange of components due to mechanical complications and/or infection and were present in 7.6 % of patients. 415 of the patients commented on their satisfaction with the operative result during the last follow-up: 89.9 % of patients evaluate their outcome as excellent or good, 9.4 % as moderate and only 0.7 % (3 patients) as poor. In these three cases a component loosening or symptomatic USG osteoarthritis was present. Two-year follow-up data using the American Orthopedic Foot and Ankle Society Ankle and Hindfoot Scale (AOFAS-AHS) are already available for 115 patients. The median AOFAS-AHS score increased from 33 points preoperatively to more than 80 points three to six months postoperatively. This increase remained nearly constant over the entire two-year follow-up period. CONCLUSION: Covering less than 10 % of the approximately 240 providers in Germany and approximately 12 % of the annually implanted total ankle-replacements, the D. A. F.-register is still far from being seen as a national registry. Nevertheless, geographical coverage and inclusion of "high-" (more than 100 total ankle replacements a year) and "low-volume surgeons" (less than 5 total ankle replacements a year) make the register representative for Germany. The registry data show that the number of subsequent interventions and in particular the "true revision" procedures are markedly lower than the 20 % often postulated in the literature. In addition, a high level of patient satisfaction over the short and medium term is recorded. From the perspective of the authors, these results indicate that total ankle arthroplasty - given a correct indication and appropriate selection of patients - is not inferior to an ankle arthrodesis concerning patients' satisfaction and function. First valid survival rates can be expected about 10 years after the register's start.

[Randomised pilot study for quantification of benefit from the patient's point of view of deep oscillation treatment in primary wound healing]. / Randomisierte Pilotstudie zur Quantifizierung des patientenseitigen Nutzens der Beeinflussung primärer Wundheilungsprozesse durch Tiefenoszillation.

UNLABELLED: BACKGROUND AND AIM OF THE INVESTIGATION: Deep oscillation refers to an electromechanical therapy method in which electrostatic attraction and friction, produced by the use of a hand-held applicator, create resonance vibrations in treated tissue. In a pilot clinical trial the impact of deep oscillation has been examined in relation to the physiological parameters of wound healing on postoperative wounds. MATERIAL AND METHODS: Following osteosynthesis operations (extremities and spinal column), 40 patients were stratified by operation localisation and randomised into two samples (intervention [n = 20], control [n = 20]). Aside from primary care of the operation wound, finding-oriented deep oscillation was applied for at least one week following the operation in the intervention sample. The intra-individual reduction in postoperative pain occurrence between day 2 and day 7 of the postsurgical period was quantified by means of a visual analogue scale (VAS) serving as primary clinical end point from the patient's point of view. Confirmatory analysis of this primary endpoint was based on a two-sample Wilcoxon test at the 5 % level of significance. RESULTS: According to VAS pain occurrence declined in the intervention group from day 2 to day 7 in the postoperative period by a median of 3 points (P) (quartile range -4-0.25 P) and a mean of -2.3 P, the control group remained (almost) unaltered with a median difference of 0 P (-2-0 P) and a mean difference of -0.85 P; the treatment groups differed significantly in the postoperative profile of VAS-based pain sensation (Wilcoxon p = 0.006). None of the secondary endpoints showed any locally significant sample differences. DISCUSSION: These results demonstrate a significant pain-alleviating effect of deep oscillation. However, the exact physiological effects underpinning the impact of deep oscillation are still not completely understood.

[Metaanalysis to estimate the expected drop out-rates reported in clinical trials on cataract surgery]. / Metaanalyse zur Schätzung der in klinischen Studien zur Kataraktchirurgie zu erwartenden drop out-Rate.

BACKGROUND: A realistic sample size calculation is crucial to achieve significant results in clinical trials. As an expected drop out-rate has to be included in the sample size calculation, current practice consists in the presumption of drop out-rates published in previous similar investigations. This approach may, however, result in severely over- or under-estimated sample sizes. Therefore this meta-analysis sought to aggregate the drop out-rates from published clinical trial reports on cataract surgery to derive a quantitative suggestion for the planning of future clinical trials. METHODS: The data collection was a complete review of all prospective and retrospective studies in five journals of the years 2002-2012; trial-wise recall rates of subjects at follow-up 3, 6, 12, and 24 months after recruitment were documented. The primary endpoint of the meta-analysis was the reported drop out-rates after 6 months. 95 % confidence intervals were calculated for each trial, respectively; a median drop out-rate was estimated including its 95 % confidence interval. The drop-out-rate estimates were furthermore stratified by design characteristics of the reported studies. RESULTS: For randomised clinical trials on cataract surgery, the median drop out-rate increased during the follow-up period of 24 months from 4 % at three months to 17 % at 24 months after recruitment; for the six-month drop out-rate a median drop-out rate of 3 % (95 % CI 0 %; 14 %) was estimated. CONCLUSION: Drop out-rates in sample size calculations for clinical trials on cataract surgery were found to be over-estimated in general, ending up in the calculation of overly large patient numbers and thereby in both ethical and economic consequences. For randomised clinical trials on cataract surgery the median drop out-rate can be expected to be 5 % during a six-month follow-up and may rise up to 15 % during a 12-month trial period.

[Mild whole body hyperthermia in combination with inpatient multimodal oriented pain therapy: evaluation in patients with chronic unspecific lumbar back pain]. / Milde Ganzkörperhyperthermie in Kombination mit stationärer multimodal orientierter Schmerztherapie: Evaluation bei Patienten mit chronischem unspezifischem lumbalem Rückenschmerz.

PURPOSE: A randomized controlled clinical trial was implemented to evaluate the effectiveness of combined mild hyperthermia therapy (body core temperature 38.4 °C) and multimodal inpatient rehabilitation for patients suffering from chronic low back pain when compared to multimodal pain therapy alone. PATIENTS AND METHODS: A total of 88 patients were randomly assigned to the combined or single therapeutic schemes according to a block randomization scheme. According to the trial inclusion criteria all patients suffered from chronic low back pain and showed morphological degeneration. All patients underwent a 12-day inpatient multimodal pain therapy, which was complemented with a 6-session schedule of mild hyperthermia therapy for the intervention group (1 h at 38.6 °C). On admission and 3 months after treatment the study patients were asked to complete an interview assessment with the Oswestry low back pain disability questionnaire (Oswestry disability index). The change in the Oswestry disability index total score (%) 3 months after versus before therapy was defined as the primary clinical endpoint of the investigation. The patients in the control group and in the intervention group had a median age of 50 years. In the intervention group 70 % of the patients were female and 55 % reported having half to full time employment compared to 55 % and 43 % in the control group, respectively. RESULTS: On admission the control patients reported a median Oswestry disability index of 64 % and on recall the same of 64 %. The intervention group showed median Oswestry disability index estimates of 60 % and 66 %, respectively. The changes in the overall Oswestry disability index after 3 months differed significantly with an estimated 6 % for the intervention group versus 0 % for the control group (Wilcoxon p = 0.050). CONCLUSION: When combined with a multimodal inpatient lower back pain functional therapy in patients showing morphological degeneration, the mild hyperthermia therapy demonstrated statistically significant, although not clinically relevant benefits in comparison to the multimodal treatment alone. However, regarding the moderate overall patient-related benefits as measured in terms of the Oswestry disability index, the benefit of the underlying multimodal therapy concept implementation must be critically discussed irrespective of its combination with mild hyperthermia therapy.

[How is ophthalmic undersupply demonstrated in socially disadvantaged people? Cross-sectional pilot investigation on the parametrisation of endpoints for patient-centred care research]. / Worin manifestiert sich eine eventuelle augenärztliche Unterversorgung sozial schlechter gestellter Menschen? Pilotstudie zur Wahl versorgungswissenschaftlicher Endpunkte.

BACKGROUND: Many people depend on additional help to maintain their daily needs. In these circumstances preventive medical check-ups are frequently not attended, so that disease development may remain undetected until advanced stages or correctable disorders may not be treated. A fully anonymised cross-sectional study was set up to assess feasibility of parametrisation and to quantify sensitive indicators for screening for possible ophthalmic undersupply in socially disadvantaged people. METHODS: In 2011 a free, voluntary and anonymous ophthalmic examination was offered to attendees of the "Oberhausener Tafel" social project. The visual acuity was checked with adjustment of the objective refractional error via autorefractor, without or with glasses (if available). In addition, an examination of the anterior and posterior segments of the eye was done in miosis. As primary endpoint a corrected visual acuity of > 0.5 combined with a presenting visual acuity ≤ 0.5 on the same eye in at least one eye was considered. A key secondary endpoint was defined as the absolute deviation of at least 1 D in at least one eye between the spherical equivalent measurement of the corrective values of the glasses and the autorefractor readings. The primary intention of this pilot investigation was to assess the feasibility of this endpoint parametrisation and to quantify the corresponding endpoint prevalences. RESULTS: Data of 37 participants could be evaluated, 28 of whom brought their glasses. The best available visual acuity ranged from 0.12 to 1.3 with a median per eye of 0.63. In comparison, the corrected visual acuity per eye was 0.8 (range 0.32-1.0). In 54 % the presenting visual acuity was one- or both-eyed ≤ 0.5, but could be reduced to 30 % (one- or both-eyed) after correction of the objective refractional error. In summary, presenting visual acuity in comparison to corrected visual acuity showed potential for an at least one-eyed improvement for at least two lines in 46 % of the participants. Furthermore, 19 participants showed disorders concerning the anterior or posterior eye segment. CONCLUSION: In the examined population the visual acuity could be improved by two lines in merely 50 % of the participants by adjusting refractive errors. The results indicate the need for discussion on how to lower the threshold for attending preventive ophthalmic examinations.

[Potentials and limitations of the planned compulsory quality assurance program for cataract surgery (Qesü)]. / Potenziale und Grenzen der geplanten obligatorischen Qualitätssicherung für Kataraktoperation (Qesü).

Cataract surgery is scheduled for a federal program for quality improvement across the different sectors of care (outpatient care and hospitals). In case of implementation not only ophthalmic surgeons but all ophthalmologists would have to contribute to the documentation. Urgency, potential benefits and limitations of a compulsory compared to a voluntary quality assessment system are analyzed.

[Result-related success rates of cataract operations. Results of a systematic literature review]. / Ergebnisbezogene Erfolgsraten der Kataraktoperation. Ergebnisse einer systematischen Literaturübersicht.

This systematic literature review, including 7 publications released since 2000, provides references for outcome indicators of cataract surgery for quality management initiatives. The reported relative numbers of cases achieving visual rehabilitation and refractive accuracy were determined and compared. With one exception the success rates did not represent benchmarks defined as best possible outcome but describe the results of data collected in a population during routine clinical practice. A best corrected visual acuity (BCVA) of ≥ 0.5 was achieved in 84-93% of all patients and in 95-99% of patients without preoperative visually impairing comorbidities. A refractive accuracy (absolute deviation of target refraction from spherical equivalent) of ≤ 1 D was reported in 72-97% of the patients. The success rates of these well established outcome indicator levels were high. Differences between operators were more distinguishable and the clinical relevance higher with less liberal indicator levels. A BCVA ≥ 1 was realized in 30-47% of all patients and in 52-62% of patients without visually impairing comorbidities. A total of 45-80% of the patients showed a refractive accuracy of ≤ 0.5 D. Exogenous factors not influencable by the surgeon have a relevant impact on the success rates. The literature review confirms the strong association of visually impairing comorbidities and BCVA outcome. Based on literature methodological problems of quality management systems for cataract surgery are discussed. While voluntary initiatives have the ability to solve these difficulties appropriate concepts for mandatory procedures are currently lacking.

[Evaluation of possible prognostic factors for the course of visual acuity after intravitreal ttriamconolone acetonide]. / Evaluation möglicher prognostischer Merkmale für den Visusverlauf nach intravitrealer Triamzinoloninjektion.

BACKGROUND: Intrvitreal injections are increasingly applied in the treatment of macular oedema of different origins. So far no clear preoperative prognostic factors are known. This investigation was implemented to quantify the predictive value of preoperative retinal sensitivity assessments by means of microperimetry with regard to the short-term course of visual acuity. METHODS: 42 patients with macular oedema due different ocular diseases (such as diabetic maculopathy, retinal vein occlusion, Irvine Gass syndrome) were examined pre- and postoperatively by means of microperimetry, fixation, optical coherence tomography and fluorescein angiography. Their medical history, treatment to date, visual acuity, central retinal thickness and retinal sensitivity were recorded before and six weeks after intravitreal injection of triamcinolone acetonide. RESULTS: The data from 38 injections could be evaluated; 21 eyes showed an improvement in visual acuity of more than one line. However, statistically significant prognostic factors could not be identified: patients with a visual acuity increase of at least one line showed a median total retinal sensitivity of 8.5 dB (5.0-11.0 dB) versus 8.3 dB (3.6-12.8 dB) in patients with unchanged or decreasing visual acuity (Wilcoxon p = 0.706). The same tendency was observed in retinal thickness with medians of 618 µm (483-689 µm) versus 558 µm (447-621 µm; Wilcoxon p = 0.220). However, a moderate association of the visual outcome with the 6 weeks change in total retinal sensitivity was observed. Patients with visual improvement of at least one line showed a significant sensitivity increase of 1.7 dB in median versus a median decrease of 0.8 dB in patients with stable or worsened visual acuity (sign test p = 0.003 and p = 0.629, respectively). CONCLUSION: The presented data did not reveal statistically significant predictors of the short-term visual outcome after triamzinolone injection by means preoperative microperimetry assessment.

[Clinical risk management in german hospitals - does size really matter?]. / Strukturiertes Risikomanagement in Krankenhäusern - kommt es doch auf die Größe an?

PURPOSE: In the last years, German hospitals have implemented different measures to increase patient safety. Special importance has been attached to near miss reporting systems (critical incident reporting system, CIRS) as instruments for risk identification in health care, instruments that promise high potential for organisational learning. To gain insight into the current status of critical incident reporting systems and other instruments for clinical risk management, a survey among 341 hospitals was carried out in 2009. Questions covered a process of six steps: from risk strategy to methods for risk identification, to risk analysis and risk assessment, to risk controlling and risk monitoring. MATERIAL AND METHODS: Structured telephone interviews were conducted with 341 German hospitals, featuring in their statutory quality reports certain predefined key terms that indicated the concluded or planned implementation of clinical risk management. The main objective of those interviews was to check the relation between status/organisation of self-reported risk management and both operator (private, public, NPO) and size of hospital. RESULTS: The implementation of near miss reporting systems (CIRS) in German hospitals has been constantly rising since 2004: in 2009, 54 % of the interviewed hospitals reported an implemented CIRS; of these, 72 % reported the system to be hospital-wide. An association between CIRS and private, public or NPO-operator could not be detected (Fisher p = 1.000); however, the degree of CIRS implementation was significantly increasing with the size of the hospital, i.e., the number of beds (Fisher p = 0.008): only 38 % of the hospitals with less than 100 beds reported CIRS implementation against 52 % of those between 100 to 500 beds, and 67 % of those with more than 500 beds. While 62 % of the hospitals interviewed reported the maintenance of a risk management committee, only 14 % reported the implementation of risk analysing techniques. As to clinical risk management, 92 % of the hospitals see potential for internal improvement; 44 % have already communicated with external consultants. CONCLUSION: While identification of clinical risks with near miss and other incident reporting systems meets increasing acceptance, the learning potential based on incident reporting is not yet appropriately being used. There is a deficit regarding systematic and comprehensive risk assessment and controlling; this will have to be met by improving the organisational framework for clinical risk management.

[Long-term results in total knee arthroplasty. A meta-analysis of revision rates and functional outcome]. / Langzeitergebnisse in der Knieendoprothetik : Metaanalyse zu Revisionsrate und funktionellem Ergebnis.

BACKGROUND: Total knee arthroplasty (TKA) is one of the most common procedures in orthopedic surgery and clinical success can be characterized by the revision rate and improvement of function. To quantify both characteristics two independent meta-analyses have been performed. MATERIALS AND METHODS: A search in Medline provided a total of 96 studies on revision rates and 63 studies with functional results with a minimum follow-up of 5 years. RESULTS: A total of 911 revisions among 20,873 TKAs were identified corresponding to a meta-revision rate of 4.4% after a mean follow-up of 10.7 years. Most common causes for revision were aseptic loosening (31%), infection (23%), polyethylene wear (16%) and patellar problems (14%). Revision rates were higher in younger patients (7.0% <60 years at time of operation, 5.0% between 60 to 70 years and 2.2% >70 years), after cementless TKA (8.3% cementless versus 3.6% cemented) and in studies with a higher rate of patients with rheumatoid arthritis. The second meta-analysis revealed a meta-improvement based on the Knee Society Knee Score of 51.3%, for the Knee Society Function Score of 30.6%, for the Hospital for Special Surgery Score of 36.1% and for the New Jersey Orthopedic Hospital Knee Evaluation System of 33.6%. CONCLUSION: TKA is a successful treatment for osteoarthritis of the knee with an expectable revision rate of less than 5% within 10 years and a long-lasting functional improvement of more than 30% in any assessment score.

[Clinical pathway for total knee arthroplasty (EGON). II. The impact of enhanced patient information]. / Klinischer Behandlungspfad zur Implantation einer Oberflächenknieendoprothese (EGON). II: Effekt einer intensivierten Patienteninformation.

PURPOSE: The effects of the introduction of a clinical pathway and enhanced patient information on patients' satisfaction were investigated in the current study. MATERIAL AND METHODS: In a prospective cohort study patients were systematically interviewed about the preparation and the clinical course during implantation of a total knee arthroplasty. The study included 132 patients before (cohort I) and 128 after (cohort II) introduction of a clinical pathway. All patients of cohort II were offered the opportunity to attend an enhanced patient information lecture. The collected data were analysed in a descriptive manner. Items with more than 10% negative answers constituted the need for improvement. RESULTS: Regarding preparation of the operation there was a need for improvement of 11 items in cohort I and 4 in cohort II. With respect to the clinical course there was a slight increase from 6 to 7 items that required improvement. The enhanced information about the treatment and the clinical course were assessed positively. Patients were unsatisfied with the individual explanation of the X-rays. Of 128 patients from cohort II, 58 decided to participate in the information session for patients. The patients who had attended were more interested in receiving additional information. The success of the operation (gain in WOMAC score of at least 20%) showed a substantial effect on patient satisfaction. CONCLUSION: With increased patient information the knowledge and patient satisfaction within clinical pathways can be improved.