A 12-week DBPC dose-finding study with sublingual monomeric allergoid tablets in house dust mite-allergic patients.

BACKGROUND: In sublingual immunotherapy, optimal doses are a key factor for therapeutic outcomes. The aim of this study with tablets containing carbamylated monomeric house dust mite allergoids was to determine the most effective and safe dose. METHODS: In this double-blind, placebo-controlled dose-finding study, 131 patients with house dust mite-induced allergic rhinoconjunctivitis were randomized to 12-week treatments with 300 UA/day, 1000 UA/day, 2000 UA/day, 3000 UA/day or placebo. Conjunctival provocation tests (CPT) were performed before, during and after treatment. The change in mean allergic severity (primary endpoint), calculated from the severity of the CPT reaction, and the proportion of patients with an improved CPT threshold (secondary endpoint) determined the treatment effect. RESULTS: The mean allergic severity decreased in all groups, including the placebo group. It was lower in all active treatment groups (300 UA/day: 0.14, 1000 UA/day: 0.15, 2000 UA/day: 0.10, 3000 UA/day: 0.15) than in the placebo group (0.30). However, this difference was not statistically significant (P < 0.1). The percentage of patients with an improved CPT threshold was higher in the active treatment groups (300 UA/day: 73.9%; 1000 UA/day: 76.0%; 2000 UA/day: 88.5%; 3000 UA/day: 76.0%) than in the placebo group (64.3%). The difference between placebo and 2000 UA/day was statistically significant (P = 0.04). In 13 (10%) exposed patients, a total of 20 treatment-related adverse events of mild severity were observed. CONCLUSIONS: The 12-week daily treatment using 2000 UA/day monomeric allergoid sublingual tablets is well tolerated and reduces the CPT reaction in house dust mite-allergic patients.

Propofol sedation for colonoscopy with a new ultrathin or a standard endoscope: a prospective randomized controlled study.

BACKGROUND AND STUDY AIMS: The majority of colonoscopies in Germany are performed under conscious sedation. Previous studies reported that pediatric colonoscopes reduce the demand for sedative drugs and may improve cecal intubation. The aim of this study was to compare a new ultrathin and a standard colonoscope in terms of propofol demand during colonoscopy. PATIENTS AND METHODS: A total of 203 patients were prospectively randomized to undergo colonoscopy with either a 9.5-mm ultrathin (UTC) colonoscope or a standard colonoscope of variable stiffness. Initially, 40 or 60 mg of propofol were administered according to body weight, followed by bolus injections of 20 mg as deemed necessary. Propofol was administered by a separate physician who was blinded to the endoscope used. Sedation levels were defined according to guidelines; pain and complaints were recorded on a numeric rating scale. RESULTS: Significantly less propofol was required to reach the cecum with the UTC (adjusted mean 94.9 mg [95 % confidence interval (CI) 85.7 - 105.0] vs. 115.3 mg [95 %CI 105.8 - 124.7]; P = 0.003). The level of sedation and pain score were lower with the UTC (sedation level 1 76 % vs. 61 %; P = 0.003; pain score adjusted mean 2.0 [95 %CI 1.7 - 2.4] vs. 2.8 [95 %CI 2.5 - 3.1]; P = 0.001). The rate of ileal and cecal intubation, time to reach the cecum, number of external compressions, withdrawal time, polyp and adenoma detection rate, and patient satisfaction were not different between the two colonoscopes. The time to intubate the ileum was longer with the UTC (1.73 minutes [95 %CI 1.42 - 2.04] vs. 1.22 minutes [95 %CI 0.91 - 1.52]; P = 0.020). CONCLUSIONS: Use of a new ultrathin colonoscope was associated with reduced propofol consumption, lower patient sedation levels, and less pain than the standard colonoscope, but ileal intubation time was longer.

[Sound levels in nursery schools]. / Lärm in Kindertagesstätten.

INTRODUCTION: Children and teenagers often suffer from hearing loss because of exposure to sound levels above 100 dB generated by toys, portable music players and stereo equipment in discotheques. Even in nursery schools and schools, considerable noise levels are produced by children's voices. METHODS: Sound levels were measured in a nursery school in Cologne in four different rooms, each with 22 children aged between 3 and 6 years and two teachers. Sound dosimeters detected sound levels in each room for 5 days of the week. These were positioned in the room above the playing children as well as near the teachers' ears. The same measurements were repeated after the children had been instructed about noise and possible noise damage. In addition, the children were now able watch the "noise lights", an instrument resembling traffic lights which translated the sound levels actually measured in their room into optical signals. A questionnaire containing 13 questions about noise and sensitivity to noise was distributed to 35 teachers at nursery schools in the Cologne municipal area. RESULTS: Mean sound levels of an 8-h/day measuring period (L(eq)) were 80.1 ± 2.3 dB(A) near the ear of the teacher and 70.87 ± 2.5 dB(A) measured in the room. The maximal sound level for 1 s, L(max) dB(A), was 112.55 ± 2.3 dB(A) near the ear and 103.77 ± 8.1 dB(A) in the room. After the children had learned about noise and were able to check the sound level they produced with the help of the "noise lights", a tendency towards a reduction of sound levels in the room and near the teachers' ears could be seen. An evaluation of the questionnaire revealed the high physical strain and emotional stress the teachers were subjected to due to noise. CONCLUSIONS: Children and teachers in nursery schools are subjected to high sound levels. Therefore, the education and early sensitization of children to noise in order to prevent prospective hearing damage, e.g. using the "noise light", should be set as a goal. Soundproofing measures are also possible. Further investigations to assess the effects of these measures are planned.

Skin sclerosis is only of limited value to identify SSc patients with severe manifestations--an analysis of a distinct patient subgroup of the German Systemic Sclerosis Network (DNSS) Register.

OBJECTIVES: In SSc, diagnosis and classification is based mainly on skin sclerosis. Herein, we investigated in a large multicentre cohort, to what extent skin sclerosis reflects organ involvement and additional clinical symptoms. METHODS: A total of 1200 SSc patients from the register of the German Systemic Sclerosis Network (DNSS), classified as either lcSSc or dcSSc, were analysed for their serological characteristics, clinical symptoms and organ manifestations in relation to skin involvement measured by the modified Rodnan skin score (mRSS). RESULTS: SSc patients with different mRSS did not differ significantly in their disease duration and in most of the clinical symptoms. They showed a similar distribution of most organ manifestations such as pulmonary arterial hypertension as well as cardiac, renal and nervous system involvement. More severe skin thickening was found to be associated with pulmonary fibrosis and gastrointestinal symptoms, as well as with digital ulcers and musculoskeletal involvement. CONCLUSIONS: In patients with SSc, potentially life-threatening complications and clinical symptoms with high impact on the quality of life occur independently from the extent of skin sclerosis. The diagnosis in SSc patients with a low mRSS could be missed or they could be insufficiently treated.

[Should all patients with thyroid nodules > or = 1 cm undergo fine-needle aspiration biopsy?]. / Soll man alle Schilddrüsenknoten > or = 1 cm punktieren?

The prevalence of thyroid nodules > or = 1 cm is high in a previously iodine-deficient area. Under the hypothesis, that all patients with such nodules undergo fine-needle aspiration biopsy (FNAB) and that sensitivity and specificity of cytology are calculated with 85%, the positive predictive value of pathologic cytologic finding will reach 1.5% only according to Bayes-theorem. This is clinically unacceptable, as resection will be the consequence in all cases with suspect cytology. Even implementation of a second, independent test (e. g. moleculargenetic testing of thyreocytes, sensitivity to detect mutation 50%, specificity 95%) and application of sequential Bayes-theorem the positive predictive value of combined pathologic findings will increase to 13% only. Nevertheless, 58% out of all thyroid cancer remain undetected by such a sequential algorithm. As a consequence , pre-selection of thyroid nodules for FNAB is required to increase the pretest-probability to at least 5-10%. A combination of sonographic criteria and scintigraphy, even in patients with normal TSH-levels, is suited to selected thyroid nodules for FNAB.

The registry of the German Network for Systemic Scleroderma: frequency of disease subsets and patterns of organ involvement.

OBJECTIVE: Systemic sclerosis (SSc) is a rare, heterogeneous disease, which affects different organs and therefore requires interdisciplinary diagnostic and therapeutic management. To improve the detection and follow-up of patients presenting with different disease manifestations, an interdisciplinary registry was founded with contributions from different subspecialties involved in the care of patients with SSc. METHODS: A questionnaire was developed to collect a core set of clinical data to determine the current disease status. Patients were grouped into five descriptive disease subsets, i.e. lcSSc, dcSSc, SSc sine scleroderma, overlap-syndrome and UCTD with scleroderma features. RESULTS: Of the 1483 patients, 45.5% of patients had lcSSc and 32.7% dcSSc. Overlap syndrome was diagnosed in 10.9% of patients, while 8.8% had an undifferentiated form. SSc sine scleroderma was present in 1.5% of patients. Organ involvement was markedly different between subsets; pulmonary fibrosis for instance was significantly more frequent in dcSSc (56.1%) than in overlap syndrome (30.6%) or lcSSc (20.8%). Pulmonary hypertension was more common in dcSSc (18.5%) compared with lcSSc (14.9%), overlap syndrome (8.2%) and undifferentiated disease (4.1%). Musculoskeletal involvement was typical for overlap syndromes (67.6%). A family history of rheumatic disease was reported in 17.2% of patients and was associated with early disease onset (P < 0.005). CONCLUSION: In this nationwide register, a descriptive classification of patients with disease manifestations characteristic of SSc in five groups allows to include a broader spectrum of patients with features of SSc.

Pharmacokinetics of ibuprofen sodium dihydrate and gastrointestinal tolerability of short-term treatment with a novel, rapidly absorbed formulation.

OBJECTIVE: This paper describes four studies investigating the dissolution, plasma pharmacokinetics and safety of a novel, fast-acting ibuprofen formulation, ibuprofen sodium dihydrate. MATERIAL AND METHOD: Four separate studies investigated: the in vitro dissolution rates of ibuprofen sodium dihydrate (at pH 1.2, 3.5 and 7.2); the bioavailability of ibuprofen sodium dihydrate (in two pharmacokinetic studies; combined n = 38) compared with conventional ibuprofen, ibuprofen lysinate, ibuprofen arginate and ibuprofen liquagels (all 2 x 200 mg ibuprofen); and the gastroduodenal tolerance of ibuprofen sodium dihydrate and ibuprofen arginate (both 2 x 200 mg ibuprofen t.i.d.) in an endoscopy safety study, where endoscopy was performed at baseline and at the end of each treatment period using a five-point scale to assess the integrity of the gastric and duodenal mucosa. RESULTS: Ibuprofen sodium dihydrate dissolved significantly more rapidly at pH 1.2, 3.5 and 7.2 than conventional ibuprofen, ibuprofen lysinate and ibuprofen liquagels. Ibuprofen sodium dihydrate had similar C(max) to ibuprofen lysinate and ibuprofen liquagels and significantly higher Cmax than conventional ibuprofen (p = 0.002). The mean plasma concentration for ibuprofen sodium dihydrate was significantly higher than for conventional ibuprofen (p = 0.028) 10 minutes post-dose and the t(max) for ibuprofen sodium dihydrate was reached significantly earlier than for conventional ibuprofen (p = 0.018). All three formulations were bioequivalent according to the acceptable boundaries (90% confidence intervals). No statistically significant difference was observed between the ibuprofen formulations in terms of adverse events and specifically with respect to hemorrhagic scores; 41 (46.0%) adverse events (AEs) occurred after administration of ibuprofen sodium dihydrate, and 46 (52.9%) after ibuprofen arginate. One occurrence of an invasive ulcer was observed after administration of ibuprofen arginate. CONCLUSIONS: The new formulation of ibuprofen sodium dihydrate dissolves quickly in vitro, has the same extent of absorption as other fast-acting ibuprofen formulations, and is absorbed into plasma more rapidly than conventional ibuprofen. In addition, the present studies suggest that the tolerability and safety profile of ibuprofen sodium dihydrate is comparable to existing ibuprofen formulations.

A ruler for interpreting diagnostic test results.

OBJECTIVES: Bayes' rule formalizes how the pre-test probability of having a condition of interest is changed by a diagnostic test result to yield the post-test probability of having the condition. To simplify this calculation a geometric solution in form of a ruler is presented. METHODS: Using odds and the likelihood ratio of a test result in favor of having the condition of interest, Bayes' rule can succinctly be expressed as "the posttest odds equals the pre-test odds times the likelihood ratio". Taking logarithms of both sides yields an additive equation. RESULTS: The additive log odds equation can easily be solved geometrically. We propose a ruler made of two scales to be adjusted laterally. A different, widely used solution in form of a nomogram was published by Fagan. CONCLUSIONS: Whilst use of the nomogram seems more obvious, the ruler may be easier to operate in clinical practice since no straight edge is needed for precise reading. Moreover, the ruler yields more intuitive results because it shows the change in probability due to a given test result on the same scale.

Treatment of acute bronchitis in adults with a pelargonium sidoides preparation (EPs 7630): a randomized, double-blind, placebo-controlled trial.

BACKGROUND: Acute bronchitis is a widespread medical problem, and, although predominantly caused by viruses, antibiotics are still prescribed unnecessarily. Therefore, it is of utmost importance to evaluate the use of alternative treatments for acute bronchitis. OBJECTIVE: To evaluate the efficacy and safety of a Pelargonium sidoides preparation (EPs 7630 is a registered trademark of Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany) compared with placebo in patients with acute bronchitis. DESIGN: Randomized, double-blind, placebo-controlled trial using a design with planned interim analyses. SETTING: Six outpatient clinics. PATIENTS: One hundred twenty-four adults with acute bronchitis present /=five points, and informed consent. INTERVENTION: EPs 7630 or placebo (30 drops three times daily) for seven days. MEASUREMENTS: The primary outcome criterion was the change of BSS on day seven. RESULTS: The decrease of BSS from baseline to day seven was 7.2 +/- 3.1 points with EPs 7630 (n = 64) and 4.9 +/- 2.7 points with placebo (n = 60). The 95% confidence interval for the difference of effects between the two treatment groups (EPs 7630 minus placebo) was calculated as (1.21, 3.56) showing a significant improvement of EPs 7630 compared with placebo on day seven (P < .0001). For each of the five individual symptoms, rates of complete recovery were considerably higher in the EPs 7630 group. Within the first four days, onset of treatment effect was recognized in 68.8% of patients in the EPs 7630 group compared with 33.3% of patients in the placebo group (P < .0001). Health-related quality of life improved more in patients treated with EPs 7630 compared with placebo-treated patients. Adverse events occurred in 25 of 124 patients (EPs 7630: 15/64 patients, placebo: 10/60 patients). All adverse events were assessed as nonserious. CONCLUSIONS: EPs 7630 was superior in efficacy compared with placebo in the treatment of adults with acute bronchitis. It may therefore offer an effective alternative for acute bronchitis unless antibiotics are clearly indicated.

Drop the Likelihood Ratio. A Novel Non-electronic Tool for Interpreting Diagnostic Test Results.

OBJECTIVE: To present a geometric ruler to determine predictive values of binary diagnostic test results from prevalence, sensitivity and specificity without calculation. METHODS: On logarithmic scale the relationships between pre-/post-test odds and the likelihood ratio as well as sensitivity, specificity and the likelihood ratio appear as simple linear (additive) equations. RESULTS: Each of these additive equations can be solved geometrically in form of a ruler with three scales. By amalgamation we devise a novel non-electronic tool which omits the intermediate step of likelihood ratio determination. CONCLUSIONS: We propose a simple geometric method to aid in interpretation of diagnostic test results for both practical and educational purposes.

Diaplacental carcinogenic effects of 5-azacytidine in NMRI-mice.

5-Azacytidine was applied to NMRI-mice (1-2 mg/kg) either on gestation day 12, 14, or 16. In the first case it mainly induced leukemias, while in the latter experiments leukemias, lung adenomas and soft tissue sarcomas represent the main effects. The experiments performed on gestation day 14 led to tumor rates below the spontaneously occurring tumor frequencies in NMRI-mice. There is a clear-cut inverse dose-response relationship in leukemia induction, as the higher dose principally shows a lower degree of effectiveness. This, as well as a reduction of tumor frequency below control levels after application of this drug on day 14, can be explained by an "overkill" effect. The cytotoxic and embryolethal efficacy of the agent thus surpasses the transformation effects at the cellular genome. While a negative correlation between the general embryotoxicity of azacytidine and the simultaneous tumor inducibility is to be observed, there is no correlation at the target organ level between the embryotoxic and the carcinogenic effects.

Tumor promotion in a breast cancer model by exposure to a weak alternating magnetic field.

In view of the methodological problems of epidemiological studies on associations between exposures to 50/60 Hz magnetic fields (MF) and increased incidence of cancers, laboratory studies are necessary to determine if 50/60 Hz MF are cancer promoters or can progress cancers. The objective of the present study was to determine if an alternating MF of low flux density exerts tumor-promoting or co-promoting effects in a model of breast cancer in female rats. Mammary tumors were induced by the chemical carcinogen 7,12-dimethylbenz(a)anthracene (DMBA). A group of 99 rats was exposed to a homogeneous MF of 50 Hz, 100 microT (microtesla), for 24 h/day 7 day/week for a period of 91 days; another group of 99 rats was sham-exposed under the same environmental conditions as the MF-exposed rats. The exposure chambers were identical for MF-exposed and sham-exposed animals. DMBA was administered orally at a dose of 5 mg/kg at the first day of exposure and at weekly intervals thereafter up to a total dose of 20 mg per rat. The animals were palpated once weekly to assess the development of mammary tumors. In controls, DMBA induced tumors in about 40% of the animals within three months of first application. Eight weeks after DMBA application the MF-exposed rats exhibited significantly more tumors than sham-exposed animals. This difference in the rate of tumor development was observed throughout the period of exposure. At the end of the three-month period of MF exposure the tumor incidence in MF-exposed rats was 50% higher than in sham-exposed rats, the difference being statistically significant. Furthermore, the size of tumors as estimated by palpation was significantly larger in the MF-exposed compared to sham-exposed rats. The data demonstrates that long-term exposure of DMBA-treated female rats to an alternating MF of low flux density promotes the growth and increases the incidence of mammary tumors, thus strongly indicating that MF exposure exerts tumor-promoting and/or copromoting effects.

Dose rate and fractionation of total body irradiation in dogs: short and long term effects.

Variations of regimens of total body irradiation (TBI) were investigated in the dog as a preclinical model for bone marrow transplantation. Inactivation of hemopoietic precursor cells (CFU-GM) was studied following irradiation of marrow in vitro, following TBI at sublethal doses in vivo and following autologous transplantation of marrow obtained after sublethal TBI. Inactivation and recovery of CFU-GM as well as restoration of hemopoiesis following autologous transplantation was independent of the dose rate, but nadirs of blood counts were lower following sublethal TBI with the higher dose rate. Acute non-hemopoietic toxicity of TBI depended on the dose, the dose rate and the total treatment time and not on the fractionation regimen. At a total dose of 25 Gy acute mortality was prevented by prophylactic administration of oral, non-absorbable antibiotics. Late mortality was due to degenerative and autoimmune-like disorders with or without infections and to malignant tumors. Evaluation of long-term survival is still preliminary, since surviving dogs of two groups (10 Gy as single dose, 25 Gy as hyperfractionated TBI) have not yet reached the median survival time of their group. So far, long-term survival depended on the total dose (p = 0.05) and, possibly, the fractionation regimen (p = 0.12). The latency period until development of malignant tumors was influenced by the total doses given in the same treatment time (p = 0.05) and by the total treatment time for equal doses (p = 0.04). It was concluded that TBI at a low dose rate may give the best therapeutic ratio of inactivation of hemopoietic precursor cells to acute toxicity.(ABSTRACT TRUNCATED AT 250 WORDS)

The standardised mistletoe extract PS76A2 improves QoL in patients with breast cancer receiving adjuvant CMF chemotherapy: a randomised, placebo-controlled, double-blind, multicentre clinical trial.

Patients with breast cancer receiving adjuvant chemotherapy frequently suffer from a restricted quality of life (QoL) due to the side-effects of chemotherapy and the consequences of coping with the diagnosis. Therefore, the objective of this clinical study was to investigate the impact of PS76A2, an aqueous mistletoe extract standardised to the galactoside-specific mistletoe lectin, on QoL by performing a placebo-controlled trial. Overall, 272 patients with breast cancer receiving adjuvant CMF chemotherapy (cyclophosphamide-methotrexate-fluorouracil) were enrolled and randomised to groups receiving placebo or PS76A2 at concentrations of 10, 30 or 70 ng mistletoe lectin (ML) per ml. The patients received 0.5 ml study medication twice weekly subcutaneously for 15 consecutive weeks (4 CMF cycles). Primary variables were the self-assessment QoL scores GLQ-8 (Global Life Quality) and Spitzer's uniscale. As a result, statistically significant effects on QoL were obtained with the medium dose (15 ng ML/0.5 ml). The treatment difference between the medium dose and placebo with regard to the GLQ-8 sum was 60.8 mm (95% confidence interval: 19.3 to 102.0 mm). The treatment effect for Spitzer's uniscale between the medium dose and placebo was 16.4 mm (95% confidence interval: 6.3 to 26.6 mm). The results on QoL were supported by an increase of T helper lymphocytes (CD4+) and the CD4+/CD8+ ratio (p<0.05). Overall, PS76A2 was well tolerated. Local reactions at the injection sites occurred dose-dependently, but were mild at the low and medium dose levels.

Factors which provoke post-infarction depression: results from the post-infarction late potential study (PILP).

Symptoms of depression in the majority of patients immediately following acute myocardial infarctions (AMI) resolve rapidly; they are an adjustment reaction. However, in a group of 552 male patients there were 80 (14.5%) patients with persistent major depressive symptoms during a finite period after AMI. Infarction size was assessed by maximum creatine kinase levels, the QRS-complex and the occurrence of late potentials. These measures did not correlate with the degree of depressed moods in these groups. An arrhythmic event in the early hospitalization phase, a recurrent infarction, dyspnoea, and persistent angina pectoris before the AMI were significantly related to more profound degrees of depression. Patients who reported serious life-events in the last 2 yr before AMI, or who suffered from exhaustion and fatigue in the prehospital phase were subject to significantly higher levels of depression. A prodromal phase prior to hospitalization free of bodily symptoms and the use of denial were related to low levels of depression. The logistic regression model incorporating all univariate significant variables revealed that symptoms of exhaustion and fatigue prior to AMI had the strongest independent correlation with post AMI depression.

The mutagenic effect of caprolactam in the spot test with (T x HT) F1 mouse embryos.

The mouse spot test was used to investigate the in vivo mutagenicity of caprolactam. Among offspring treated with 500 mg/kg, the frequency of spots was increased over controls in 4 separate experiments, leading to the conclusion that caprolactam is mutagenic in the spot test.

Mutagenicity testing of vincristine sulfate in germ cells of male mice.

Vincristine sulfate (VCR) affects the fertilization ability of all germ-cell stages in male mice. The reduced fertilization ability leads to a pseudo-dominant-lethal effect and sterile matings. The frequency of these effects is dose-dependent. The frequency of specific-locus mutations was not increased by VCR in male mice following 2 mg/kg bw treatment.

[Quality control of outpatient imaging examinations in North Rhine-Westphalia, Part II]. / Qualitätskontrolle der ambulanten bildgebenden Diagnostik in Nordrhein-Westfalen, Teil II.

PURPOSE: In the state of North Rhine-Westphalia (NRW), Germany, a survey was conducted on radiologic examinations ordered by general practitioners (GPs). Part II of this study aims to determine the quality of the process and outcome. The reference standard is the assessment of both radiologists and physicians without board certification in radiology working at a university hospital and in outpatient facilities. MATERIALS AND METHODS: AllGPs in NRW were asked to cooperate. Participating GPs filled out a questionnaire for each patient. The patients recorded the symptoms prompting the imaging examinations. The radiologists or other physicians performing the examinations were asked to provide the images and written reports and to complete a questionnaire. A file was created for each of the 394 patients with image documentation of at least one examination. Each file, which included medical history, physical findings, imaging documentation and written report, was sequentially forwarded to a board-certified radiologist and to a physician without board certification in radiology working in a university hospital and in an outpatient facility. All physicians were requested to complete a structured questionnaire for each file. RESULTS: The referral diagnoses were rated as medically plausible in 81%, the indications for imaging found correct in 76%, the examination techniques considered appropriate in 69%, the clinical question answered in 63%, the interpretation judged medically correct in 50% and all incidental findings documented in 49%. In retrospect, 32 % of the examinations were judged superfluous. The sequence of multiple examinations performed on a particular patient was rated as appropriate in 51%. The interpretation revealed specialty-related differences. The plausibility of the referral diagnoses had a significant impact on the appropriateness of subsequent diagnostic investigations. Marked deficits showed sonography, performance by non-radiologists, self-referrals by GPs, gastroenterologic radiology and the ICD-10 coding (suspicion of cardiovascular disease). CONCLUSION: In the "best-case" scenario, the process quality proved to have moderate deficiencies and the outcome quality severe deficiencies. In consequence, GPs and radiologists should be more communicative by sharing information and exchanging opinions. GP self-referrals should be restricted. Sonography and examinations performed by physicians without board certification in radiology should undergo stricter quality controls. A more intensive interdisciplinary collaboration is needed to determine the optimum implementation of diagnostic imaging of gastroenterologic and cardiovascular diseases.