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Biomedical subjects

Peter Bauer

Publications and source records attributed to Peter Bauer.

At least 19 recordsLinked to original sources

Elucidating the clinical and genetic spectrum of inositol polyphosphate phosphatase INPP4A-related neurodevelopmental disorder.

PURPOSE: Biallelic INPP4A variants have recently been associated with severe neurodevelopmental disease in single-case reports. Here, we expand and elucidate the clinical-genetic spectrum and provide a pathomechanistic explanation for genotype-phenotype correlations. METHODS: Clinical and genomic investigations of 30 individuals were undertaken alongside molecular and in silico modelling and translation reinitiation studies. RESULTS: We characterize a clinically variable disorder with cardinal features, including global developmental delay, severe-profound intellectual disability, microcephaly, limb weakness, cerebellar signs, and short stature. A more severe presentation associated with biallelic INPP4A variants downstream of exon 4 has additional features of (ponto)cerebellar hypoplasia, reduced cerebral volume, peripheral spasticity, contractures, intractable seizures, and cortical visual impairment. Our studies identify the likely pathomechanism of this genotype-phenotype correlation entailing translational reinitiation in exon 4 resulting in an N-terminal truncated INPP4A protein retaining partial functionality, associated with less severe disease. We also identified identical reinitiation site conservation in Inpp4a-/- mouse models displaying similar genotype-phenotype correlation. Additionally, we show fibroblasts from a single affected individual exhibit disrupted endocytic trafficking pathways, indicating the potential biological basis of the condition. CONCLUSION: Our studies comprehensively characterize INPP4A-related neurodevelopmental disorder and suggest genotype-specific clinical assessment guidelines. We propose that the potential mechanistic basis of observed genotype-phenotype correlations entails exon 4 translation reinitiation.

Humans↗

Clinical and genetic delineation of autosomal recessive and dominant ACTL6B-related developmental brain disorders.

PURPOSE: This study aims to comprehensively delineate the phenotypic spectrum of ACTL6B-related disorders, previously associated with both autosomal recessive and autosomal dominant neurodevelopmental disorders. Molecularly, the role of the nucleolar protein ACTL6B in contributing to the disease has remained unclear. METHODS: We identified 105 affected individuals, including 39 previously reported cases, and systematically analyzed detailed clinical and genetic data for all individuals. Additionally, we conducted knockdown experiments in neuronal cells to investigate the role of ACTL6B in ribosome biogenesis. RESULTS: Biallelic variants in ACTL6B are associated with severe-to-profound global developmental delay/intellectual disability, infantile intractable seizures, absent speech, autistic features, dystonia, and increased lethality. De novo monoallelic variants result in moderate-to-severe global developmental delay/intellectual disability, absent speech, and autistic features, whereas seizures and dystonia were less frequently observed. Dysmorphic facial features and brain abnormalities, including hypoplastic corpus callosum, and parenchymal volume loss/atrophy, are common findings in both groups. We reveal that in the nucleolus, ACTL6B plays a crucial role in ribosome biogenesis, particularly in pre-rRNA processing. CONCLUSION: This study provides a comprehensive characterization of the clinical spectrum of both autosomal recessive and dominant forms of ACTL6B-associated disorders. It offers a comparative analysis of their respective phenotypes provides a plausible molecular explanation and suggests their inclusion within the expanding category of "ribosomopathies."

Humans↗

Estimation in flexible two stage designs.

Adaptive test designs for clinical trials allow for a wide range of data driven design adaptations using all information gathered until an interim analysis. The basic principle is to use a test statistics which is invariant with respect to the design adaptations under the null hypothesis. This allows for a control of the type I error rate for the primary hypothesis even for adaptations not specified a priori in the study protocol. Estimation is usually another important part of a clinical trial, however, is more difficult in adaptive designs. In this research paper we give an overview of point and interval estimates for flexible designs and compare methods for typical sample size rules. We also make some proposals for confidence intervals which have nominal coverage probability also after an unforeseen design adaptation and which contain the maximum likelihood estimate and the usual unadjusted confidence interval.

Clinical Trials as Topic↗

Repeat expansion in spinocerebellar ataxia type 17 alleles of the TATA-box binding protein gene: an evolutionary approach.

The variability and mutational changes of the CAG microsatellite in the TATA-box binding protein gene (TBP) were studied. We sequenced the microsatellite of the TBP gene of 25 unrelated individuals from northern Germany (10 SCA17 patients and 15 unaffected control individuals). In addition, the microsatellites were sequenced from individuals of 10 northern German families with at least one family member affected by SCA17. To study also the evolutionary history of this CAG/CAA microsatellite in nonhuman primates, the homologous regions were analysed from Pan troglodytes, Gorilla gorilla, Pongo pygmaeus, P. abellii, Hylobates lar, Nomascus leucogenys, Symphalangus syndactylus, Macaca mulatta, Papio hamadryas, Colobus polykomos and Callithrix jacchus. Three major conclusions were drawn: (i) Patterns of synonymous CAA interruptions in the microsatellite are characteristic and likely to result from selection for stabilizing the repetitive region; (ii) Interspecific comparisons indicate that SCA17 is likely to be a human trait. The most common allele in humans (37 repeats) is close to the threshold value upon which neurodegenerative changes can occur and may act as a repository for expanded, pathogenic alleles; (iii) The cassette-like structure of five out of 17 expanded alleles can be attributed to unequal crossing over. This can explain the rare and sporadic de novo generation of SCA17 alleles.

Animals↗

Screening for mutations of the HFE gene in Parkinson's disease patients with hyperechogenicity of the substantia nigra.

Iron mediated oxidative stress is known to contribute to the neurodegenerative process in Parkinson's disease (PD). Although there are hints that genes involved in brain iron metabolism might be involved in the pathogenesis of PD in some instances, it is still not known whether the increase in brain iron content constitutes a primary or secondary event in the disease cascade. Recent studies on the role of hemochromatosis gene (HFE) mutations in PD vary from a protective effect of C282Y heterozygosity, no effect of the C282Y or H63D mutation to an increased risk for PD in C282Y mutation carriers. In this study, analyzing the whole coding region of the HFE gene by dHPLC in 278 PD patients, priorly characterized by transcranial sonography for increased iron content of the substantia nigra (SN), we did not find an association of the common HFE mutations and PD. However, we identified two novel variants (K92N and I217T) each in a single PD patient. These variations were not found in any of the controls. Future studies are necessary to reveal a possible functional relevance of these mutations for PD. Our results indicate that mutations in the HFE gene are not a common cause for PD with increased iron levels of the SN.

Aged↗

Predictors of early recovery of health status after intensive care.

OBJECTIVE: To identify factors predictive of good or poor recovery of health status and health-related quality of life (HRQOL) 90 days after admission to an intensive care unit (ICU). DESIGN AND SETTING: Prospective international multicentre study in 19 ICUs participating in the HRQOL substudy of the SAPS 3 project. INTERVENTION: The EuroQol questionnaire (EQ) was administered to discharged ICU patients 90 days after admission. A question to compare present health status with that 3 months before ICU admission (same/better/worse) was added. PATIENTS: Six hundred and eighteen patients who spent >24h in an ICU and survived for 90 days. EQ data and health comparison were available in 559 (90.5%) of them. MEASUREMENTS AND RESULTS: Patients reported their general level of health to be better (33.8%), the same (31.1%), or worse (35.1%) in comparison with baseline. Recovery was considered to be good for answers "better" or "the same". Regression analysis showed that transplantation surgery [odds ratio (OR) 0.07, 95% confidence interval (CI) 0.01-0.63], coronary artery bypass surgery without valvular repair (OR 0.39, 95% CI 0.17-0.92) and being admitted to the ICU from a ward or other location (OR 0.55, 95% CI 0.31-0.95) predicted good recovery of health. Predictors of poor recovery (all present at the time of ICU admission) were unplanned ICU admission, hypothermia, serum creatinine level >or=2mg/dl, pH<or=7.25 and metastatic cancer. CONCLUSIONS: More than 60% of ICU patients report good recovery of their health 90 days after ICU admission, depending on their illness and circumstances of ICU admission.

Argentina↗

Patient safety in intensive care: results from the multinational Sentinel Events Evaluation (SEE) study.

OBJECTIVE: To assess on a multinational level the prevalence and corresponding factors of selected unintended events that compromise patient safety (sentinel events) in intensive care units (ICUs). DESIGN: An observational, 24-h cross-sectional study of incidents in five representative categories. SETTING: 205 ICUs worldwide MEASUREMENTS: Events were reported by intensive care unit staff members with the use of a structured questionnaire. Both ICU- and patient-related factors were assessed. RESULTS: In 1,913 adult patients a total of 584 events affecting 391 patients were reported. During 24 h multiple errors related to medication occurred in 136 patients; unplanned dislodgement or inappropriate disconnection of lines, catheters, and drains in 158; equipment failure in 112; loss, obstruction or leakage of artificial airway in 47; and inappropriate turn-off of alarms in 17. Per 100 patient days, 38.8 (95% confidence interval 34.7-42.9) events were observed. In a multiple logistic regression with ICU as a random component, the following were associated with elevated odds for experiencing a sentinel event: any organ failure (odds ratio 1.13, 95% confidence interval 1.00-1.28), a higher intensity in level of care (odds ratio 1.62, 95% confidence interval 1.18-2.22), and time of exposure (odds ratio 1.06, 95% confidence interval 1.04-1.08). CONCLUSIONS: Sentinel events related to medication, indwelling lines, airway, and equipment failure in ICUs occur with considerable frequency. Although patient safety is recognised as a serious issue in many ICUs, there is an urgent need for development and implementation of strategies for prevention and early detection of errors.

Adolescent↗

Genetic analysis of candidate genes modifying the age-at-onset in Huntington's disease.

The expansion of a polymorphic CAG repeat in the HD gene encoding huntingtin has been identified as the major cause of Huntington's disease (HD) and determines 42-73% of the variance in the age-at-onset of the disease. Polymorphisms in huntingtin interacting or associated genes are thought to modify the course of the disease. To identify genetic modifiers influencing the age at disease onset, we searched for polymorphic markers in the GRIK2, TBP, BDNF, HIP1 and ZDHHC17 genes and analysed seven of them by association studies in 980 independent European HD patients. Screening for unknown sequence variations we found besides several silent variations three polymorphisms in the ZDHHC17 gene. These and polymorphisms in the GRIK2, TBP and BDNF genes were analysed with respect to their association with the HD age-at-onset. Although some of the factors have been defined as genetic modifier factors in previous studies, none of the genes encoding GRIK2, TBP, BDNF and ZDHHC17 could be identified as a genetic modifier for HD.

Acyltransferases↗

The German hospital malnutrition study.

BACKGROUND & AIMS: Malnutrition is frequently observed in chronic and severe diseases and associated with impaired outcome. In Germany general data on prevalence and impact of hospital malnutrition are missing. METHODS: Nutritional state was assessed by subjective global assessment (SGA) and by anthropometric measurements in 1,886 consecutively admitted patients in 13 hospitals (n=1,073, university hospitals; n=813, community or teaching hospitals). Risk factors for malnutrition and the impact of nutritional status on length of hospital stay were analyzed. RESULTS: Malnutrition was diagnosed in 27.4% of patients according to SGA. A low arm muscle area and arm fat area were observed in 11.3% and 17.1%, respectively. Forty-three % of patients 70 years old were malnourished compared to only 7.8% of patients <30 years. The highest prevalence of malnutrition was observed in geriatric (56.2%), oncology (37.6%), and gastroenterology (32.6%) departments. Multivariate analysis revealed three independent risk factors: higher age, polypharmacy, and malignant disease (all P<0.01). Malnutrition was associated with an 43% increase of hospital stay (P<0.001). CONCLUSIONS: In German hospitals every fourth patient is malnourished. Malnutrition is associated with increased length of hospital stay. Higher age, malignant disease and major comorbidity were found to be the main contributors to malnutrition. Adequate nutritional support should be initiated in order to optimize the clinical outcome of these patients.

Adolescent↗

The end of submacular surgery for age-related macular degeneration? A meta-analysis.

BACKGROUND: The aim of this meta-analysis was to summarize and to discuss the results of the four main submacular surgical procedures for age-related macular degeneration (AMD) as reported in the literature through 2004 and to compare them to the Submacular Surgery Trials (SST) data. METHODS: The existing data in the literature on submacular surgery for AMD from 1992 to 2004 were evaluated. The main outcomes were proportion of patients with two or more lines of improvement in visual acuity (VA) and proportion with two or more lines of deterioration in VA after surgery. RESULTS: Eighty-eight studies including 1,915 cases met the inclusion criteria. Estimates for the treatment outcome within the four groups of treatment based on a logistic regression model gave comparable results for removal of choroidal neovascularization (CNV) (improvement of VA 28%, deterioration of VA 25%), macular translocation (improvement of VA 31%, deterioration of VA 27%), and for transplantation of pigment epithelium (improvement of VA 22%, deterioration of VA 21%). Estimates for removal of subretinal hemorrhage were significantly different (improvement of VA 62%, deterioration of VA 13%). CONCLUSIONS: Selected case series showed superior results of VA compared to the SST. The question of whether this is due to selection bias that seems inevitable when dealing with medium-sized nonrandomized case series or due to better results in single centers cannot be answered. In our opinion there still seem to be indications for submacular surgery such as in patients with AMD with low preoperative VA due to large hemorrhagic or fibrotic membranes or nonresponders to photodynamic therapy (PDT).

Humans↗

CAG repeats in Restless Legs syndrome.

Recent reports established an association of restless legs syndrome (RLS) and spinocerebellar ataxia (SCA) type 1, 2, and 3. To evaluate the contribution of SCA alleles to idiopathic RLS we investigated the CAG repeat length at the SCA1, SCA2, SCA3, SCA6, SCA7, and SCA17 loci in 215 patients who fulfilled the clinical criteria of RLS and presented periodic leg movements in sleep (PLMS) in polysomnographic recording. Fifty percent of patients had a positive family history of RLS. We found one intermediate (CAG)(43) allele for SCA17 in a 44-year-old female with RLS starting at the age of 43. Neurologic examination and family history were unremarkable in this patient. Otherwise, allele distribution did not differ between RLS patients and healthy controls. Stratification for age, age of onset, sex, peripheral neuropathy, and sporadic or familial RLS revealed no effect. Thus, CAG repeat length in the investigated genes is not a major determinant of idiopathic or familial RLS.

Adult↗

The reassessment of trial perspectives from interim data--a critical view.

If an interim analysis is performed during a trial it is tempting to determine the conditional power to reach a rejection in the trial given the observed results in the interim analysis. Since the true effect size is unknown the conditional power may be calculated by using the effect size, which the study has been powered for in the planning phase or by using an interim estimate of the true size (or a combination of both). In either case the conditional power is a random variable and its density is investigated depending on the analysis time and the true effect size. Under the null hypothesis, in early interim analyses after a small proportion of sample units, the conditional power typically will be close to the overall power when the effect size from the planning stage is used for calculation. In this case the majority of observations must still be made and the small first-stage sample in general will be dominated by the hypothetical second-stage chance based on the wrong parameter value. It is shown that the conditional power in moderately underpowered studies can have a distribution symmetric around 0.5. When using the interim estimate for calculating the conditional power the density in general will be u-shaped. The impact of using conditional power to reassess the sample size using flexible two-stage combination tests is shown for a specific example in terms of overall power and average sample size as compared to the corresponding group sequential design. For small true effect sizes mid-trial sample size recalculation based on an interim estimate may lead to an overly large price to be paid in average sample size in relation to the gain in overall power. Finally, the problem is discussed in terms of estimating the true conditional power.

Clinical Trials as Topic↗

Spectrin mutations in spinocerebellar ataxia (SCA).

Recently, betaIII spectrins have been recognized as ataxia disease genes, with the identification by Ikeda and co-workers of pathogenic mutations in the SPTBN2 gene in three large (and mapped) SCA5 families of American and European origin.((1)) With their discovery, the large "Lincoln" family has been traced back to the underlying genetic defect for the slowly progressive cerebellar ataxia. In addition, the involvement of this component of the cytoskeleton directs attention towards the possible role of organelle stability during neurodegeneration. The findings suggest that the mechanical properties of neurons and their dynamics may be as important as altered Ca(2+) homeostasis, transcriptional dysregulation, and impaired protein degradation in neurodegeneration conditions.

Humans↗

An adaptive hierarchical test procedure for selecting safe and efficient treatments.

We consider the situation where during a multiple treatment (dose) control comparison high doses are truncated because of lack of safety and low doses are truncated because of lack of efficacy, e.g., by decisions of a data safety monitoring committee in multiple interim looks. We investigate the properties of a hierarchical test procedure for the efficacy outcome in the set of doses carried on until the end of the trial, starting with the highest selected dose group to be compared with the placebo at the full level alpha. Left truncation, i.e., dropping doses in a sequence starting with the lowest dose, does not inflate the type I error rate. It is shown that right truncation does not inflate the type I error if efficacy and toxicity are positively related and dose selection is based on monotone functions of the safety data. A positive relation is given e.g. in the case where the efficacy and toxicity data are normally distributed with a positive pairwise correlation. A positive relation also applies if the probability for an adverse event is increasing with a normally distributed efficacy outcome. The properties of such truncation procedures are investigated by simulations. There is a conflict between achieving a small number of unsafely treated patients and a high power to detect safe and efficient doses. We also investigated a procedure to increase power where a reallocation of the sample size to the truncated treatments and the control remaining at the following stages is performed.

Biometry↗

Methodological developments vs. regulatory requirements.

This is a discussion of the following three papers appearing in this special issue on adaptive designs: 'FDA's critical path initiative: A perspective on contributions of biostatistics' by Robert T. O'Neill, 'A regulatory view on adaptive/flexible clinical trial design' by H. M. James Hung, Robert T. O'Neill, Sue-Jane Wang and John Lawrence; and 'Confirmatory clinical trials with an adaptive design' by Armin Koch.

Biometry↗

Survival endpoints and adaptive designs.

This is a discussion of the paper 'Planning and analyzing adaptive group sequential survival trials' by Gernot Wassmer, appearing in this special issue on adaptive designs.

Biometry↗

Mutations in TITF1 are not relevant to sporadic and familial chorea of unknown cause.

Benign hereditary chorea (BHC; OMIM 118700) is an autosomal dominant movement disorder. Mutations in the thyroid transcription factor 1 (TITF1) gene have been linked with BHC. The phenotype for BHC is highly variable and may include atypical features such as dystonia, slow saccades, and even cognitive deficits. Although BHC is commonly transmitted in a dominant manner, assessment of TITF1 mutations in familial or sporadic patients with late-onset nonprogressive or early-onset progressive chorea is of practical relevance in order to evaluate diagnostic strategies in single patients. In this study, 18 patients with chorea of unknown cause including index patients of three families with autosomal dominantly inherited nonprogressive chorea have been screened for TITF1 mutations by means of denaturating high-pressure liquid chromatography (dHPLC). No sequence variations were detected for the complete open reading frame, suggesting that TITF1 mutations are not a common cause of sporadic or familial chorea of unknown cause. Additionally, linkage analysis excluded TITF1 mutations in a large family with benign hereditary chorea.

Adolescent↗