Prognostic risk factors for apical root resorption in orthodontic patients - Are the Kjær's morphologic characteristics of clinical relevance?

BACKGROUND: Patients undergoing orthodontic treatment (OT) face an increased risk of developing external apical root resorption (EARR). A prognostic risk assessment prior to OT can potentially be conducted through anatomical features in panoramic radiography. This retrospective study aimed to assess the significance of Kjær's morphological characteristics in analyzing the risk of EARR. METHODS: Panoramic radiographs of 1,156 patients (624 females, 532 males) were retrospectively analyzed. Anamnestic and treatment-related data were extracted from patient records. The mean age at the start of OT was 12.8 ± 2.2 years (min. 6.4 years, max. 22.3 years) and at the end of OT 15.9 years (min. 8.5 years, max. 24.1 years). The mean treatment duration was 3.1 ± 1.6 years. Panoramic radiographs with a minimum of two per patient were examined for the presence of Kjær's characteristics. The degree of EARR was registered defining resorption in four degrees of severity. Bivariate analysis and multivariate Poisson regression were performed to assess the association between Kjær's characteristics and EARR patient- and tooth- related (α = 0.05). RESULTS: In total, 72.8% of the patients showed EARR at the end of OT with lateral maxillary incisors most frequently affected. Short roots (p < 0.001) were significantly associated with EARR in patients. Tooth-related microdontia (#12, #22, lower second premolars), narrow crowns (#11, #21, lower incisors), short roots (upper incisors, lower first molars) and ectopia (#11, #21, #13), such as shorter distal roots of the mandibular first molar showed a significant association with EARR depending on severity degree. The type of orthodontic appliance (fixed: p < 0.001, fixed and removeable: p = 0.008), as well as treatment duration (p < 0.001) were also identified as risk factors for EARR. CONCLUSIONS: Although the risk assessment for EARR development through panoramic radiography analysis is limited, predisposition appears to be present in specific dental characteristics and treatment-related factors.

A volunteer-supported walking programme to improve physical function in older people with restricted mobility (the POWER Study): a randomised controlled trial.

BACKGROUND: Regular physical activity has multiple health benefits, especially in older people. Therefore, the World Health Organization recommends at least 2.5 h of moderate physical activity per week. The aim of the POWER Study was to investigate whether volunteer-assisted walking improves the physical performance and health of older people. METHODS: We approached people aged 65 years and older with restricted mobility due to physical limitations and asked them to participate in this multicentre randomised controlled trial. The recruitment took place in nursing homes and the community setting. Participants randomly assigned to the intervention group were accompanied by volunteer companions for a 30-50 min walk up to three times a week for 6 months. Participants in the control group received two lectures that included health-related topics. The primary endpoint was physical function as measured with the Short Physical Performance Battery (SPPB) at baseline and 6 and 12 months. The secondary and safety endpoints were quality of life (EQ-5D-5L), fear of falling (Falls Efficacy Scale), cognitive executive function (the Clock Drawing Test), falls, hospitalisations and death. RESULTS: The sample comprised 224 participants (79% female). We failed to show superiority of the intervention with regard to physical function (SPPB) or other health outcomes in the intention-to-treat analyses. However, additional exploratory analyses suggest benefits in those who undertook regular walks. The intervention appears to be safe regarding falls. CONCLUSIONS: Regular physical activity is essential to preserve function and to improve health and quality of life. Against the background of a smaller-than-planned sample size, resulting in low power, and the interference of the COVID-19 pandemic, we suggest that community based low-threshold interventions deserve further exploration. TRIAL REGISTRATION: The trial was registered with the German Clinical Trials Register ( www.germanctr.de ), with number DRKS00015188 on 31/08/2018.

Remineralizing potential of the biomimetic P11-4 self-assembling peptide on noncavitated caries lesions: A retrospective cohort study evaluating semistandardized before-and-after radiographs.

BACKGROUND: Self-assembling peptide (SAP) P11-4 was introduced to treat initial caries lesions by means of guiding hydroxyapatite regeneration within the lesion. The objective of this study was to assess its effectiveness in a practical clinical setting. METHODS: Caries lesions in permanent teeth treated with monomeric and polymeric SAP P11-4 from May 2015 through October 2020 were retrospectively analyzed at lesion and child levels by means of bite-wing radiography for changes in stage and cavitation and restoration. RESULTS: Two hundred and nineteen children aged 10 through 19 years with a total of 405 proximal lesions in posterior teeth were followed from 0.4 through 5.5 years (median, 7 months; interquartile range, 6-19 months). Regression occurred in 37% of stage RA1 (radiolucency in the outer one-half of enamel) (95% CI, 31% to 44%), 38% of stage RA2 (radiolucency in the inner one-half of enamel plus or minus the enamel-dentin junction) (95% CI, 30% to 45%), and 40% of stage RA3 (radiolucency limited to the outer one-third of dentin) (95% CI, 16% to 68%) lesions. The proportion of lesions with no cavitation was 0.96 (95% CI, 0.94 to 0.98) after 1 year and 0.91 (95% CI, 0.88 to 0.95) after 2 years. CONCLUSIONS: Real-world clinical data indicate that SAP P11-4 can lead to recovery and a healthier tooth stage. PRACTICAL IMPLICATIONS: SAP P11-4 is a safe treatment for initial caries lesions in permanent teeth that remineralizes in the deepest zone of the lesion and can be introduced easily into routine dental practice.

Metabolic Signature of Atypical Fibroxanthoma and Pleomorphic Dermal Sarcoma: Expression of Hypoxia-inducible Factor-1α and Several of Its Downstream Targets.

Metabolic reprogramming mediated by hypoxia-inducible factors play a crucial role in many human cancers. HIF-1α is activated under hypoxic conditions and is considered a key regulator of oxygen homoeostasis during tumor proliferation under hypoxia. Aim of this research was to analyze the immunohistochemical expression of HIF-1α, VEGF-A, Glut-1, MCT4, and CAIX in atypical fibroxanthoma (AFX) and pleomorphic dermal sarcoma (PDS). 21 paraffin-embedded AFX and 22 PDS were analysed by immunohistochemistry, namely HIF-1α, VEGF-A (referred to as VEGF throughout the manuscript), Glut-1, MCT4, and CAIX. To quantify the protein expression, we considered the percentage of positive tumor cells (0: 0%, 1: up to 1%, 2: 2-10%, 3: 11-50%, 4: >50%) in relation to the staining intensity (0: negative, 1: low, 2: medium, 3: strong). HIF-1α expression (mean ± SD) in AFX (9.33±2.92) was significantly stronger than that in PDS (5.90±4.38; P= 0.007), whereas the expression of VEGF, Glut-1, MCT4, and CAIX did not show differences between AFX and PDS. When comparing all tumors without subgroup stratification, the expression of HIF-1α (P= 0.044) and MCT4 (P= 0.036) was significantly stronger in ulcerated tumors than in tumors without ulceration. Our findings provide the first evidence that HIF-1α-induced metabolic reprogramming may contribute to the pathogenesis of AFX and PDS. HIF-1α expression seems to be higher in AFX than in PDS, and ulcerated tumors show higher expression levels of HIF-1α and MCT4 irrespective of the diagnosis.

Dying in the ICU : Changes in end of life decisions from 2011 to 2018 in the ICU of a communal tertiary hospital in Germany.

BACKGROUND: With modern intensive care medicine, even older patients and those with pre-existing conditions can survive critical illnesses and major operations; however, unreflected application of intensive care treatment might lead to a state called chronic critical illness. Today, withholding treatment and/or treatment withdrawal precede many deaths in the intensice care unit (ICU). We looked at changes in measures at the end of life and withholding or withdrawal of treatment in the ICU of a German tertiary hospital in 2017/2018 compared to 2011/2012. METHODS: In this retrospective explorative study, we analyzed end of life practices in adult patients who died in an intermediate care unit (IMC)/ICU of Klinikum Hanau in 2017/2018. We compared these data with data from the same hospital in 2011/2012 RESULTS: Of the 1246 adult patients who died in Klinikum Hanau in 2017/2018, 433 (35%) died in an ICU or IMC unit. Deceased ICU patients were 74.0 ± 12.5 years and 86.6% were older than 60 years. At least one life-sustaining measure was withheld in 278 (76.2%) and withdrawn in 159 (46.3%) of patients. More than three quarters of patients (n = 276, 75.6%) had a do not resuscitate (DNR) order and in about half of the patients invasive ventilation (n = 175, 49.9%) or renal replacement therapy (n = 191, 52.3%) was limited. In 113 patients (31.0%) catecholamine treatment was withdrawn, in 72 (19.7%) patients invasive ventilation and in 49 (13.4%) patients renal replacement therapy. Compared to 2011/2012, we saw an increase by ~15% (absolute increase) in withholding and withdrawal of treatment and observed an effect of documents like advance directive or healthcare proxy. CONCLUSION: In 76.2% of deceased ICU patients withholding treatment and in 43.6% treatment withdrawal preceded death. Compared to 2011/2012 treatment was withheld or withdrawn more often. Compared to 2011/2012, we saw an increase (~15% absolute) in withholding and withdrawal of treatment. After withholding or withdrawal of treatment, most patients died within 3 and 2 days, respectively.

[Psychological Stress and its Consequences for the Cost of Illness: a Longitudinal Study in Germany]. / Psychische Belastung und ihre Folgen für die Krankheitskosten ­ eine Längsschnittstudie in Deutschland.

OBJECTIVE: The aim of this study was to examine the effects of mental illness on the level and composition of medical costs (outpatient costs, hospital costs, rehabilitation costs, drug costs) over time. METHOD: In a longitudinal design, we examined the psychological distress of 3,287 study participants from the adult general population using the Hospital Anxiety and Depression Scale (HADS) and its effect on the level and composition of medical costs resulting from mental illness in the year of survey t0 and the two subsequent years [t1] {t2}. RESULTS: Compared to the reference group with no mental distress, the cost of illness was significantly increased by a factor of 2.0 [2.2] {1.5} in the low mental distress group, by a factor of 3.7 [4.2] {3.1} in those with moderate mental distress, and by a factor of 7.5 [9.0] {5.2} in those with severe mental distress. Over time, significant effects on illness costs appeared only at the two outer edges of psychological distress levels (no and severe distress levels). As the level of mental distress increased, hospital costs dominated total costs due to mental distress and the proportion of outpatient medical costs in total costs decreased. CONCLUSIONS: The costs of illness rise steeply with the degree of mental stress. Preventing the progression of mental illness is therefore important not only from an individual but also from a health economic perspective.

Caries Experience and Increment in Children Attending Kindergartens with an Early Childhood Caries Preventive Program Compared to Basic Prophylaxis Measures-A Retrospective Cohort Study.

Dental caries constitutes a public health challenge. As preventive strategies are desirable, this retrospective cohort study aimed to assess the caries experience and increment in children attending kindergartens with an early childhood caries (ECC) preventive program (intervention group, IG) compared to basic prophylaxis measures (control group, CG) located in areas of different socioeconomic status (SES) within Marburg (Germany). The long-term caries experience (2009−2019) of these 3−5-year-old kindergarten children was evaluated. For the caries increment, dental records of 2019 were screened for the availability of a minimum of two dental examinations at least 8 months apart. Caries was scored according to the WHO criteria (dmf−t). The data were split by observation period (300−550 and >550 days). Overall, 135 children (Ø 3.7 years) attended IG, and 132 children (Ø 3.6 years) attended CG. After 300−550 days, no significant differences were found between both groups regarding mean caries increment and experience (p > 0.05). After >550 days, IG with low SES exhibited a high caries experience. Fluoride varnish applications could not reduce the caries increment compared to CG in the short-term but slightly decreased the long-term caries experience. Comprehensive ECC prevention measures actively involving parents are needed to overcome the caries burden.

Children's and Parents' Marburg Sugar Index (MSI) Values: Are They Comparable?

Studies on children's nutritional behaviour (CNB) rarely compare children's answers regarding the frequency of their sugar intake with the respective statements of their parents. Therefore, data from a prevention study were used to analyse this aspect, as well as a potential correlation between Marburg Sugar Index (MSI) values and caries experience of children. The present study based its questionnaire data on CNB and caries data. Pairs of questionnaires filled in separately by children and parents of the participating families were dichotomised by either having completed the diet section entirely (Group A) or in part (Group B). The MSI scores were calculated separately for children and parents. The statistical confidence level was set at α = 0.05 (two-sided). Furthermore, the Pearson correlation coefficient was calculated and tested for "r = 0". Additionally, a test for equality of the correlations was applied. The number of available questionnaire pairs was 429 in Group A and 400 in Group B. In both groups, significant correlations between children's and parents' MSI scores (A: r = 0.301, p < 0.001; B: r = 0.226, p < 0.001) were found. Using Spearman's Rho, a significant correlation between MSI scores and children's caries experiences was observed in Group A. MSI scores based on dietary questionnaires can be used to obtain consistent information on children's CNB provided by the children themselves or their parents. This is true even when the MSI score has to be calculated on the basis of incomplete questionnaires. Questionnaire-based CNB information can improve the effectiveness of individual or group preventive measures supplemented by individually adapted nutritional counselling.

Knowledge of undergraduate dental students regarding management of caries lesions.

OBJECTIVES: Understanding of lifelong control of disease processes associated with caries and its management is an essential part of dental education. This study evaluated the dental students' knowledge of caries diagnosis and management using the International Caries Classification and Management System (ICCMS). METHODS: A survey was conducted among undergraduate dental students at two dental schools, attending the sixth (centre 1) and seventh semester (centre 2), respectively. Medical histories, clinical images and radiographs of 12 patients were compiled as anonymous cases. For each case, a specific lesion was to be assessed. In addition, the students should determine the patient's caries risk and select a treatment option. An expert report (consensus decision) was used as the reference standard. For statistical analysis, kappa statistics and binomial tests were used. RESULTS: A total of 46 students participated in this study. The percentage of agreement of responses to the reference was: centre 1: 40.7-51.3%, centre 2: 57.9-67.9%. The corresponding Kappa values were: centre 1: 0.073-0.175, centre 2: 0.315-0.432. Overall, students tended to underestimate the codes compared to the reference standard (p < 0.001). CONCLUSION: Introducing systematic content about caries diagnosis and management such as ICDAS and ICCMS in the learning objectives of undergraduate dental students can be proposed. However, in order to improve diagnosis and enable a more reliable choice of treatment options, attention should also be given to the way they are didactically taught.

Media use in gynecological and obstetric care and women's perceived level of education received of lifestyle-related risks: A cross-sectional study.

OBJECTIVE: The application of media on lifestyle-related risk factors (LRRFs) by healthcare providers to educate women may improve women's adherence, health literacy, and awareness of LRRFs, as well as offspring's health outcomes. This study investigated whether exposure to media-based education in gynecological and obstetric care is associated with LRRFs perceived levels of education received during pregnancy and lactation. METHODS: We conducted a cross-sectional, observational study across 14 randomly generated sample points in the 12 most populated cities in Baden-Württemberg, southwest Germany. Women were recruited from gynecological and obstetric institutions. Participants were 219 women who met our inclusion criteria and completed the quantitative questionnaire. We applied ordinal logistic regression analyses to calculate odds ratios (ORs) and 95% confidence intervals (CIs) of women's perceived level of education received related to healthcare providers' exposure to media-based education. RESULTS: Media-based education on LRRFs during pregnancy through gynecologists and/or midwives were significantly associated with women's perceived level of education received (gynecologists: OR = 4.26 (95% CI: 2.04, 8.90; p < .001); midwives: OR = 3.86 (95% CI: 1.66, 8.98; p = .002)). Similar results were found for media-based education through gynecologists and/or midwives on LRRFs during lactation and its association with women's self-assessed level of perceived level of education received (gynecologists: OR = 4.76 (95% CI: 2.15, 10.56; p < .001); midwives: OR = 7.61 (95% CI: 3.13, 18.53; p < .001)). CONCLUSIONS: This study suggests that the exposure to media-based education in gynecological and obstetric care increases women's perceived level of education received of LRRFs during pregnancy and lactation. Therefore, it is recommendable to apply media in gynecological and obstetric care settings.

Agreement of Bioluminescence Measurements and Visual Assessment in Monitoring Occlusal Surfaces of Permanent Teeth.

BACKGROUND: Caries lesion activity is typically assessed by visual-tactile criteria. Regular monitoring is required to detect the transition of lesions and to ensure that the initial assessment was valid. This clinical study aimed to evaluate the agreement of bioluminescence measurements (Calcivis imaging system, Cis) with visual examination to assess caries lesion activity and to monitor occlusal surfaces. METHODS: The occlusal surfaces of ninety-one permanent posterior teeth were assessed for the presence or absence of active caries lesions with ICCMS criteria and Cis measurements at three visit times: baseline (t1) and six months (t2) and 12 months (t3) after baseline. RESULTS: At the baseline visit, 70% of the included occlusal sites were assessed visually as active lesions (ICCMS codes 1 and 2). At t3, 64.8% of the sites showed signs of an active lesion. The percentage agreements between the visual and Cis methods were 87.8% (t1), 89.9% (t2) and 88.6% (t3). The corresponding κ-values were 0.71 (95% CI 0.52;0.87), 0.75 (95% CI 0.59;0.89) and 0.77 (95% CI 0.61;0.90), respectively. No significant difference between the visual and bioluminescence systems was found at any visit (p > 0.05). The results based on cluster randomization (generalized estimation equations) showed no significant differences between the visual and Cis findings for all visits (p = 0.108, Wald Χ2 with 1 df = 2.587). CONCLUSION: The bioluminescence system demonstrated substantial agreement for the activity assessment of occlusal lesions compared to the findings obtained by visual assessment over twelve months.

[Immunohistochemical analysis of a hypoxia-associated signature in melanomas with positive and negative sentinel lymph nodes : Hypoxia-associated signature of primary cutaneous melanomas]. / Immunhistochemische Analyse einer Hypoxie-assoziierten Signatur in Melanomen mit positivem und negativem Schildwächterlymphknoten : Hypoxie-assoziierte Signatur primär kutaner Melanome.

Metabolic reprogramming mediated by hypoxia-inducible factors and its downstream targets plays a crucial role in many human malignancies. Excessive proliferation of tumor cells under hypoxic conditions leads to metabolic reprogramming and altered gene expression enabling tumors to adapt to their hypoxic environment. Here we analyzed the metabolic signatures of primary cutaneous melanomas with positive and negative sentinel node status in order to evaluate potential differences in their metabolic signature. We found a positive correlation of the expression of glucose transporter 1 (GLUT-1) with tumor thickness and ulceration in all melanomas with subgroup analyses as well as in the subgroup with a negative sentinel node. Furthermore, the expression of vascular endothelial growth factor (VEGF) was positively correlated with the presence of ulceration in melanomas with positive sentinel node.

Relevant prognostic factors in patients with stage IV small intestine neuroendocrine neoplasms.

There are few, but controversial data on the prognostic role of upfront primary tumour resection and mesenteric lymph node dissection (PTR) in patients with diffuse metastatic small intestinal neuroendocrine neoplasia (SI-NEN). Therefore, the prognostic role of PTR and other factors was determined in this setting. This retrospective cohort study included patients with stage IV SI-NETs with unresectable distant metastases without clinical and radiological signs of acute bowel obstruction or ischaemia. Patients diagnosed from January 2002 to May 2020 were retrieved from a prospective SI-NEN database. Disease specific overall survival (OS) was analysed with regard to upfront PTR and a variety of other clinical (e.g., gender, age, Hedinger disease, carcinoid syndrome, diarrhoea, laboratory parameters, metastatic liver burden, extrahepatic and extra-abdominal metastasis) and pathological (e.g., grading, mesenteric gathering) parameters by uni- and multivariate analysis. A total of 138 patients (60 females, 43.5%) with a median age of 60 years, of whom 101 (73%) underwent PTR and 37 (27%) did not, were included in the analysis. Median OS was 106 (95% CI: 72.52-139.48) months in the PTR group and 52 (95% CI: 30.55-73.46) in the non-PTR group (p = 0.024), but the non-PTR group had more advanced metastatic disease (metastatic liver burden ≥50% 32.4% vs. 13.9%). There was no significant difference between groups regarding the rate of surgery for bowel complications during a median follow-up of 51 months (PTR group 10.9% and non-PTR group 16.2%, p = 0.403). Multivariate analysis revealed age < 60 years, normal C-reactive protein (CRP) at baseline, absence of diarrhoea, less than 50% of metastatic liver burden, and treatment with PRRT as independent positive prognostic factors, whereas PTR showed a strong tendency towards better OS, but level of significance was missed (p = 0.067). However, patients who underwent both, PTR and peptide radioreceptor therapy (PRRT) had the best survival compared to the rest (137 vs. 73 months, p = 0.013). PTR in combination with PRRT significantly prolongs survival in patients with stage IV SI-NEN. Prophylactic PTR does also not result in a lower reoperation rate compared to the non-PTR approach regarding bowel complications.

Assessment of the quality of routine ambulatory healthcare for common disorders in children and adolescents in Germany: study protocol for a retrospective medical record review (QualiPäd).

INTRODUCTION: The quality of healthcare in childhood and adolescence is of key importance, in order to foster a healthy development and to avoid chronic health problems. Yet, data for Germany regarding the quality of healthcare for this patient group are lacking. The QualiPäd research project aims to estimate the quality of outpatient healthcare for children and adolescents in Germany, focusing on common psychiatric and physical disorders. METHODS AND ANALYSIS: Quality indicators for seven common physical and mental childhood and adolescent clinical conditions (attention deficit/hyperactivity disorder, asthma, atopic dermatitis, depression, otitis media, conduct disorder/oppositional defiant disorder, tonsillitis) will be developed and ratified by experts, using the RAND/UCLA Appropriateness Method.Initially, 1400 medical records of children and adolescents with one of the aforementioned clinical conditions will then be randomly drawn from 40 outpatient practices in the German federal state of Hessen. The records will then be assessed regarding their adherence to the respective quality indicators. Based on this, the percentage of appropriate and inappropriate (eg, wasteful) healthcare of all clinical conditions (primary endpoint) will be estimated. Additionally, possible factors influencing the quality of care (eg, patient characteristics, type of condition, type of practice) will be identified using generalised estimation equation models. ETHICS AND DISSEMINATION: This study will show for which of the studied clinical conditions and/or patients improvement of quality of care is necessary within the German health system. Also, the quality indicators designed for the study can afterwards be implemented in regular care and thus enable regular reporting of the outpatient care of this target group. The authors plan to disseminate their findings through international, peer-reviewed scientific publications, and through presentations at national and international paediatric and child psychiatric conferences. TRIAL REGISTRATION NUMBER: DRKS00022408.

Women's Media Use and Preferences of Media-Based Interventions on Lifestyle-Related Risk Factors in Gynecological and Obstetric Care: A Cross-Sectional Multi-Center Study in Germany.

This study aimed to investigate factors affecting (1) women's media use regarding health-related behaviors during pregnancy and lactation, (2) women's preferences for media format, and (3) the content of media-based interventions on lifestyle-related risk factors during pregnancy and lactation. A cross-sectional observational multi-center study of pregnant and lactating women and women of childbearing age was carried out in 14 randomly selected obstetric and gynecologic care settings in the 12 most populated cities in Baden-Wuerttemberg, South-West Germany. Data from 219 surveyed women showed that older women, pregnant women, and lactating women have a higher probability of using media during pregnancy and lactation, respectively. The majority of women preferred a combination of analog and digital media-based interventions in gynecological (46.9%) and obstetric (47.1%) care settings and at home (73.0%). Women would like to see information brochures and flyers on health-related behaviors during pregnancy and lactation for use in gynecological and obstetric care settings, and for media use at home, they would like to have books. The probability of preferring the favored media formats in gynecological and obstetric care settings and at home were associated with pregnancy status, relationship status, socioeconomic status (SES), ethnicity, and health insurance status. About 80% of the surveyed women preferred media content regarding recommendations for a healthy lifestyle and healthy behavior during pregnancy and lactation. All of the independent variables were associated with the probability of preferring a specific media content. The SES was found to play a major role in the probability of preferring a specific media content, followed by pregnancy status, ethnicity, and health insurance status. The results from our study provide a basis for tailored preventive interventions in gynecological and obstetric care settings and for use at home. The results imply that a woman can be reached before conception, during pregnancy, or during lactation with preventive measures tailored to their requirements; however, acceptance may vary across personal attributes, such as SES, ethnicity, and others.

[Control group formation using propensity score matching: The role of primary and secondary data - Results of prevention studies]. / Kontrollgruppenbildung durch Propensity-Score-Matching: Die Rolle von Primär- und Sekundärdaten − Ergebnisse aus Präventionsstudien.

BACKGROUND: The creation of control groups in the evaluation of statutory health insurances is a key issue. Randomization represents both an ethical and a legal problem with legally guaranteed services. Matching procedures are relevant alternatives in the construction of control groups. Matchings are mostly based on secondary data from statutory health insurances (for example age, gender, cost of illness, days of incapacity to work). In this study, we examined whether matching based on secondary data alone can cause selection bias. METHODS: We used data from three large prevention studies and applied sensitivity analyses to compare the results of propensity score matchings used to create control groups on the basis of secondary data, with those obtained on the basis of both primary and secondary data. Analysis of covariance was used to investigate the impact of potential selection bias on cost effects. RESULTS: Matchings based on secondary data alone lead to control groups with similar characteristics captured by secondary data. However, the control group participants are significantly healthier (they have, for example, lower levels of pain, lower levels of psychological stress, a higher degree of quality of life) than the patients in intervention groups. This selection bias would lead to a systematic underestimation of the cost reduction produced by preventive interventions. DISCUSSION: Prevention course participants seem to have characteristics that differ from the average population (higher health orientation level, preference for prevention over medical treatment services, etc.) and cannot be captured by secondary data; therefore, matchings based on secondary data alone cause selection bias. CONCLUSIONS: Including both primary and secondary data reduces the risk of selection bias in matching procedures for prevention studies. The E-value can be used to evaluate the robustness of results with regard to selection bias.

Vascular Endothelial Growth Factor Receptor-3 Expression Predicts Sentinel Node Status in Primary Cutaneous Melanoma.

This study analysed the expression of vascular endothelial growth factor-A (VEGF), VEGFR-2, and VEGFR-3 in primary cutaneous melanomas with positive and negative sentinel node status (SLN) (a total of 58 specimens divided into 2 groups of 29 for each status). The specimens were collected from the pathological archive of the department of Dermatology, Venereology and Allergology of the University Medical Center Heidelberg. A quantification score was developed for protein expression, by considering the percentage of positive melanoma cells (0: 0%, 1: up to 1%, 2: 2-10%, 3: 11-50%, and 4: > 50%) in relation to the intensity of staining (0: negative, 1: low, 2: medium, 3: strong). Tumoural VEGFR-3 expression (mean ± standard deviation) in SLN+ tumours (9.62 ± 3.09) was significantly stronger than in SLN- tumours (6.13 ± 3.87; p < 0.001). A binary logistic regression model proved VEGFR-3 expression and tumour thickness to be significant independent predictors of SLN. These data provide evidence that VEGFR-3 expression may play a critical role in the pathogenesis of malignant melanoma and that its investigation may help to improve the selection of patients with primary cutaneous melanoma for sentinel node biopsy.

How effective and efficient are different exercise patterns in reducing back pain?

BACKGROUND: Exercise is considered an effective intervention to relieve chronic back pain. However, it is still unknown whether specific exercise patterns vary in terms of their efficiency and effectiveness. AIM: To investigate the differential health and economic effects of intensity, specificity and degree of subjective perceived physical exertion across five exercise patterns (endurance, gymnastics, fitness, back gymnastics, multimodal back exercise) in adults with back pain. DESIGN: Longitudinal observational cohort study over a period of 24 months. SETTING: Various non-therapeutic exercise facilities (e.g. outdoor, fitness centers, health insurance programs, sports clubs) across one federal state of Germany (Baden-Wuerttemberg). POPULATION: Adults with back pain (N.=2,542, Mean =46.9 years, 66% females, graded chronic back pain [GCPS] 1=40.5%, GCPS 2=27.3%, GCPS 3=20.7%, GCPS 4=11.5%). METHODS: Self-reported back pain (functional restrictions and pain = back pain function score, [BPFS]) and characteristics of exercising behavior (frequency, duration, type, physical exertion) were assessed at baseline and at 6, 12, 18 and 24 months. Direct medical costs for back disorders (international classification of diseases, dorsopathies: M40-M54) were compiled from health insurance records. RESULTS: Moderate- to high-intensity exercise patterns were effective in reducing back pain, particularly at lower levels of subjective perceived physical exertion. At these intensity levels, multimodal back exercise (i.e. exercising the spine-stabilizing muscles specifically, ergonomic training) was 14.5 times more effective than non-back specific fitness exercise in reducing BPFS. The beneficial effects of both exercise types increased with the initial severity of back pain. However, only multimodal back exercise (moderate- to high-intensity/high back specificity) was associated with a significant decrease in direct medical costs for back pain. CONCLUSIONS: Targeted exercise of the spine-stabilizing musculature at moderate to high intensities without maximum perceived exertion is effective and efficient in reducing back pain. CLINICAL REHABILITATION IMPACT: The combination of high-intensity and high-specificity exercises yielded a significant reduction in medical costs. However, the intensities in terms of muscular load in endurance training and gymnastics may not be sufficient to reduce back pain effectively.

Randomized Clinical Trial investigating Self-Assembling Peptide P11-4 for Treatment of Early Occlusal Caries.

Non-invasive caries treatment is a major focus in modern dentistry. The present study was designed to evaluate the effectiveness of monomeric self-assembling peptide P11-4 (SAP P11-4) in combination with fluoride varnish or polymeric self-assembling peptide matrix (SAPM) in treatment of non-cavitated occlusal caries. Ninety children and adolescents were included in this randomized, gold-standard-controlled clinical trial. Test Group 1 received SAP P11-4 and twice fluoride varnish at baseline and Day 180, Test Group 2 received SAP P11-4 on baseline and twice weekly SAPM (home-application), and Control Group received fluoride varnish on baseline and Day 180. Caries progression was measured by laser fluorescence, Nyvad Caries Activity, ICDAS-II-codes, and investigator assessments. Laser fluorescence changes demonstrated superior results for Test Group 1 and 2, as values decreased compared to an increase for the Control Group (p < 0.0005). ICDAS-II codes at Day 360 showed partial regression for Test Group 1 (6.7%) and Test Group 2 (20.0%) and partial progression for Control Group (23.3%) (p < 0.01). Nyvad Caries Activity yielded superior caries inactivation for Test Groups, compared to Control Group (p = 0.002). This trial showed that SAP P11-4, applied either in combination with fluoride varnish or twice weekly SAPM, was a superior treatment for early caries compared to fluoride varnish alone.

Comparing large pore lightweight mesh versus small pore heavyweight mesh in open mesh plug repair of primary and recurrent unilateral inguinal hernia - A questionnaire study for a retrospective analysis of a cohort of elective groin hernia patients using propensity score matching.

PURPOSE: For surgical treatment of inguinal hernia, large-pore, lightweight mesh has been shown to offer advantages over small-pore, heavyweight options in terms of chronic post-operative inguinal pain, but without the disadvantage of having to deal with an increased recurrence rate. Limited data are available for the mesh plug repair technique. Therefore, the primary aim of this study is to compare large-pore, lightweight mesh versus small-pore, heavyweight mesh for mesh plug repair with regard to chronic pain and recurrences in elective primary unilateral hernias. In addition, we report our experience in repairing recurrent hernias. METHODS: Using a modified version of the questionnaire from the Danish Hernia Registry, two groups were surveyed: elective primary unilateral hernias and recurrent unilateral hernias. In both groups small-pore, heavyweight mesh (HWM) and lightweight, large-pore mesh (LWM) were compared with respect to chronic pain and recurrences. Propensity score matching (PS) was carried out on a pool of 1,782 patients. Effect sizes were assessed by using Cohen's d and Cramer's V. RESULTS: If the questionnaire item 'lump/swelling' is considered as a surrogate for recurrence (clinically verified in our study), the results in primary hernias after HWM show a 6.0% recurrence rate and 7.3% after LWM (p = 0.487) with a mean follow up of 31,3 months in HWM and 29,2 months in LWM respectively. The questionnaire item 'pain impacting on work/leisure activities' was answered with Yes in 11.5% following HWM and in 10.5% following LWM (p = 0.665). After the evaluation of the overall surgical results, we did not find differences. Comparing primary and recurrent hernia repair we found below small effect size differences with respect to the items of the questionnaire. CONCLUSIONS: The use of LWM in repairing elective unilateral primary hernias by the mesh plug technique does not result in less chronic pain and more recurrences when compared with HWM. Recurrent hernias repaired by the mesh plug technique may have same outcomes like in primary hernia repair when considering the magnitude of effect sizes.