[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.

[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.

[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.

[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.

[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.

[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.

[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.

[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.

[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.

Social, educational, and occupational predictors of total hip replacement outcome.

OBJECTIVE: There is limited evidence on social, educational, and occupational factors as predictors of response to total hip replacement (THR). We aimed to analyze these factors in a large population-based setting. METHOD: Patients of the Dresden Hip Surgery Registry were recruited and the pre and post (6 months) operative functional status was assessed using the global Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) score (0-100 points). Non-response was defined a gain of <20 points in WOMAC score over a 6 months period and was analyzed with respect to six socioeconomic parameters. Multiple logistic regression modeling was applied to adjust for age, sex, BMI, co-morbidity, and preoperative functional status. RESULTS: Data from 1007 patients (mean age 61 years, STD 13; 55% women) were included. The average preoperative WOMAC score was 45.8 which increased to 84.4 after surgery. 38.2%, 36.6%, and 25.3% of the patients attended school for 8, 9, and 12 years, respectively. 54.1% were retired, 26.9% worked full time, and 6.7% received a disability pension. A 14.8% of the patients did not achieve a gain of > or =20 points in WOMAC score and were classified as non-responders. After control for confounders, significantly increased risks of non-response were found for widowed patients compared to singles [odds ratio (OR) 4.30, 1.45-12.71], those who lived alone (OR 1.70, 1.02-2.85), and patients with a disability pension compared to those who worked full time (OR 5.81, 2.33-14.46). The risk of non-response decreased with increasing length of school education (12 vs 8 years: OR 0.49, 0.27-0.89). Compared to workers, employees (OR 0.55, 0.33-0.90) and self-employed patients (OR 0.41, 0.18-0.94) showed significantly decreased risks of non-response. CONCLUSION: Socioeconomic parameters are independent predictors of response to THR. This can help to improve the health service by identifying subgroups which need special attention in order to increase the response rate.

[Effectiveness of microcurrent therapy as a constituent of post-hospital rehabilitative treatment in patients after total knee alloarthroplasty - a randomized clinical trial]. / Der Nutzen der während einer stationären Anschlussheilbehandlung applizierten Mikrostromtherapie bei Patienten nach Implantation einer Knie-Totalendoprothese - eine randomisierte, klinische Studie.

PURPOSE: This trial compared the clinical effectiveness of a combination of microcurrent therapy (M) with conventional postoperative physiotherapy treatment versus the combination of the latter with a sham (S) treatment after total knee arthroplasty (TKA) in terms of patient-related functional outcome parameters. METHODS: A total of 78 inpatients after TKA was randomized into the active versus the sham treatment samples; all patients received ten applications of their respective therapy assignment. The primary clinical endpoint of the investigation was defined as the three-months intraindividual change (%) in a patient's OSWESTRY total function score after start of treatment. Secondary endpoints were the WOMAC osteoarthritis index as well as a patient's pain profile as assessed by a visual analogue scale before start of treatment, after five and ten therapeutic applications, and three months after discharge from hospital. RESULTS: The M sample showed a median increase of 31% (22-38%) in the OSWESTRY total score from 53% before start of treatment to 91% three months afterwards; the control sample showed an increase of 18% (3-31%) in median from 56 % to 78%; the samples differed significantly in this three-months increase (p<0,001) but not in the baseline OSWESTRY score before start of treatment (p=0,841). CONCLUSION: This randomized trial could demonstrate statistically significant superiority of microcurrent therapy embedded in conventional postoperative rehabilitation treatment after TKA versus the combination with a sham treatment. The results indicate an early introduction of microcurrent therapy concepts into postoperative treatment.

[Clinical pathway for total knee arthroplasty. I: Pathway conception and effect on functional quality of results]. / Klinischer Behandlungspfad zur Implantation einer Oberflächenknieendoprothese (EGON). I: Pfadkonzeption und Effekt auf funktionelle Ergebnisqualität.

PURPOSE: The aim of the current study was to evaluate patient-centred and economic outcomes after introduction of a clinical pathway for total knee arthroplasty. METHODS: In a prospective trial two sequential cohorts of patients undergoing total knee arthroplasty were recruited. Baseline treatment was surveyed in cohort I and the clinical pathway was developed and evaluated in cohort II. Data from WOMAC, EQ-5D as well as partial cost data were collected. The study design was ratified by the local Independent Ethics Committee. RESULTS: There was an increase in WOMAC score of 39% for cohort I and 35% for cohort II in 3 months follow-up. Similar results were found for ED-5D with an increase of 30% for cohort I and 25% for cohort II. Partial cost rates could be lowered from 4303 EUR to 419 EUR. Despite this significant cost saving we were not able to improve the ratio of improvement in quality of life to costs. CONCLUSION: With the aid of a clinical pathway the process for implementation of a total knee arthroplasty was improved and treatment quality assured.

[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.

Hyperpolarised 3He MRI versus HRCT in COPD and normal volunteers: PHIL trial.

The aim of the present study was to apply hyperpolarised (HP) (3)He magnetic resonance imaging (MRI) to identify patients with chronic obstructive pulmonary disease (COPD) and alpha(1)-antitrypsin deficiency (alpha(1)-ATD) from healthy volunteers and compare HP (3)He MRI findings with high-resolution computed tomography (HRCT) in a multicentre study. Quantitative measurements of HP (3)He MRI (apparent diffusion coefficient (ADC)) and HRCT (mean lung density (MLD)) were correlated with pulmonary function tests. A prospective three centre study enrolled 122 subjects with COPD (either acquired or genetic) and age-matched never-smokers. All diagnostic studies were completed in 94 subjects (52 with COPD; 13 with alpha(1)-ATD; 29 healthy subjects; 63 males; and 31 females; median age 62 yrs). The consensus assessment of radiologists, blinded for other test results, estimated nonventilated lung volume (HP (3)He MRI) and percentage diseased lung (HRCT). Quantitative evaluation of all data for each centre consisted of ADC (HP (3)He MRI) and MLD measurements (HRCT), and correlation with forced expiratory volume in 1 s (FEV(1))/forced vital capacity (FVC) indicating airway obstruction, and the diffusing capacity of the lung for carbon monoxide (D(L,CO)) indicating alveolar destruction. Using lung function tests as a reference, regional analysis of HP (3)He MRI and HRCT correctly categorised normal volunteers in 100% and 97%, COPD in 42% and 69% and alpha(1)-ATD in 69% and 85% of cases, respectively. Direct comparison of HP (3)He MRI and CT revealed 23% of subjects with moderate/severe structural abnormalities had only mild ventilation defects. In comparison with lung function tests, ADC was more effective in separating COPD patients from healthy subjects than MLD (p<0.001 versus 0.038). ADC measurements showed better correlation with D(L,CO) than MLD (r = 0.59 versus 0.29). Hyperpolarised (3)He MRI correctly categorised patients with COPD and normal volunteers. It offers additional functional information, without the use of ionising radiation whereas HRCT gives better morphological information. We showed the feasibility of a multicentre study using different magnetic resonance systems.

Clinical and microbiological efficacy of moxifloxacin versus amoxicillin/clavulanic acid in severe odontogenic abscesses: a pilot study.

The aim of this study targeted the evaluation of the in vivo effect of moxifloxacin in the treatment of patients with severe odontogenic abscesses. This was a prospective, two-armed, randomised, unblinded, monocentric pilot study, which enrolled 21 hospitalized patients with severe odontogenic abscesses. After extraoral incision, patients were either treated with moxifloxacin 400 mg i.v. once daily or amoxicillin/clavulanic acid 2.2 g i.v. three times daily. Primary clinical endpoint was the time until clinical remission, represented by simultaneous assertion of the following criteria: body temperature <38.5 degrees C, no pain at palpation, and mouth opening similar or better than preoperatively. White blood cell count, C-reactive protein, pain, health related quality of life (HR-QoL) and length of hospital stay were recorded as secondary outcome criteria. The mean duration until reaching the primary end point was 6.6 (range, 4.3-8.8) days in the moxifloxacin group and 6.0 (range, 3.8-8.2) days in the amoxicillin/clavulanic acid group. Median days of in-house treatment ranged between five and six days for both groups. HR-QoL was highly impaired in both groups preoperatively and reached near normal on days three and four in both samples. In this pilot investigation, moxifloxacin showed promising results as compared to amoxicillin/clavulanic acid. Therefore, a larger prospective clinical trial using moxifloxacin in severe odontogenic abscesses appears encouraging. We suggest a combination of body temperature, palpatory pain, and subjective pain as a parameter for successful intervention; however, both findings need prospective validation by means of a phase III evaluation.

Short-term outcome after posterior versus lateral surgical approach for total hip arthroplasty - A randomized clinical trial.

PURPOSE: Currently, total hip replacement (THR) is most commonly performed via a posterior or a direct lateral approach, but the impact of the latter on the invention's outcome has yet not been quantified. METHODS: We compared the short-term outcome of cementless THR using the both approaches in a prospective, randomized controlled trial. 60 patients with unilateral osteoarthritis were included. Outcome assessment was performed one day before surgery and one week, four weeks, six weeks and 12 weeks after surgery, respectively, using the Harris Hip score as primary objective. RESULTS: We found no significant difference in the intraindividual Harris Hip Score improvement at the pre- and three months post-operative assessments between both treatment groups (p = 0.115). However, Harris Hip scores and most functional and psychometric secondary endpoints showed a consistent tendency of a slightly better three months result in patients implanted via the posterior approach. In contrast a significant shorter operating time of the direct lateral approach was recorded (67 minutes versus 76 minutes, p<0.001). CONCLUSION: In our opinion this slightly better short-term functional outcome after posterior approach is not clinical relevant. However, to make definitive conclusions all clinical relevant factors (i.e. mid- to long-term function, satisfaction, complication rates and long-term survival) have to be taken into account. LEVEL OF EVIDENCE: I - therapeutic.

Fuctional outcome after open and arthroscopic bankart repair for traumatic shoulder instability.

PURPOSE: Both open and arthroscopic Bankart repair are established procedures in the treatment of anterior shoulder instability. While the open procedure is still considered as the "golden standard" functional outcome is supposed to be better in the arthroscopic procedure. The aim of this retrospective study was to compare the functional outcome between open and arthroscopic Bankart repair. MATERIAL AND METHODS: In 199 patients a Bankart procedure with suture anchors was performed, either arthroscopically in presence of an detached, but not elongated capsulolabral complex (40) or open (159). After a median time of 31 months (12 to 67 months) 174 patients were contacted and agreed to follow-up, 135 after open and 39 after arthroscopic Bankart procedure. RESULTS: Re-dislocations occurred in 8% after open and 15% after arthroscopic Bankart procedure. After open surgery 4 of the 11 re-dislocations occurred after a new adequate trauma and 1 of the 6 re-dislocations after arthroscopic surgery. Re-dislocations after arthroscopic procedure occurred earlier than after open Bankart repair. An external rotation lag of 20 degrees or more was observed more often (16%) after open than after arthroscopic surgery (3%). The Rowe score demonstrated "good" or "excellent" functional results in 87% after open and in 80% patients after arthroscopic treatment. CONCLUSION: In this retrospective investigation the open Bankart procedure demonstrated good functional results. The arthroscopic treatment without capsular shift resulted in a better range of motion, but showed a tendency towards more frequently and earlier recurrence of instability. Sensitive patient selection for arthroscopic Bankart repair is recommended especially in patients with more than five dislocations.

Birmingham Hip Resurfacing arthroplasty: short-term clinical and radiographic outcome.

BACKGROUND: Aim of our study was to evaluate the clinical and radiographic outcome of the first 300 consecutively implanted Birmingham Hip Resurfacing arthroplasties (BHR) in our department. METHODS: 300 BHR arthroplasties were performed in 263 patients until May 2003. Primary clinical endpoints of the investigation were the implant survival and the total Harris hip score, assessed at the last examination. RESULTS: At a median follow-up time of 24 months the Kaplan/Meier survivor estimate was 98%. 6 implant revisions were performed due to infection (2), malposition (1), femoral neck fracture (1), primary unstable cup (1) and chronic pain (1), respectively. The median Harris hip score improved from 51 points to 96 points at last follow-up. No hip showed radiographic signs of aseptic implant loosening. CONCLUSIONS: The preliminary experience with the BHR for the younger adult requiring hip arthroplasty is encouraging, but has to be reproduced in the long-term.

[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.

Turned, machined versus double-etched dental implants in vivo.

BACKGROUND: Positive effects on the clinical outcome of moderately rough implant surfaces are described. Intercomparison of clinical data, however, is rarely found. PURPOSE: The aim of this study was to compare the clinical results of two macroscopically identical implants, the one with a turned, machined and the other with an etched surface. MATERIALS AND METHODS: In a retrospective cohort study, the included implants followed the criteria: standard surgical protocol, >12 months in situ; minimally rough self-threading implants with a turned, machined surface (Mk II Nobel Biocare AB, Göteborg, Sweden], n=210); etched implants of the same macrodesign (3i Implant Innovations Inc., Palm Beach Gardens, FL, USA], n=151), length > or = 10 mm. Clinical data and implant success were rated. Resonance frequency analysis (RFA) and Periotest (Siemens AG, Bensheim, Germany) were measured and related to the corresponding implant survival rate in the respective group. RESULTS: The total number of implants was 361, of which 264 (73%) were subject to clinical reexamination. RFA and Periotest could be recorded in 25% of the implants. Neither clinically relevant nor statistically significant differences between the surface designs were found in the RFA (64 +/- 8.6 vs 63 +/- 9.7), in Periotest (-2 +/- 3.3 vs -1 +/- 5.1), and in mean survival periods (49 months, 95% confidence interval CI]: 46-51 months, for the turned vs 46 months, 95% CI: 43-49 months, for the double-etched implant). After osteoplastic procedures, a significantly higher rate of implant losses in the turned, machined implant group was observed (17 vs 1) with a mean survival period of 43 (40-46) months for the turned and 46 (45-48) months for the double-etched implants. CONCLUSION: No difference between implants with two different minimally rough surfaces was found. A positive effect of surface roughness is observed in poor quality bone, but the pivotal proof of this effect is still lacking.