The Kinetics of COVID-19 Vaccine Response in a Community-Vaccinated Population.

We used a noninvasive electrochemical quantitative assay for IgG Abs to SARS-CoV-2 S1 Ag in saliva to investigate the kinetics of Ab response in a community-based population that had received either the Pfizer or Moderna mRNA-based vaccine. Samples were received from a total of 97 individuals, including a subset of 42 individuals who collected samples twice weekly for 3 mo or longer. In all, >840 samples were collected and analyzed. In all individuals, salivary SARS-CoV-2 S1 IgG Ab levels rose sharply in the 2-wk period after their second vaccination, with peak Ab levels seen at 10-20 d after vaccination. We observed that 20%, 10%, and 2.4% of individuals providing serial samples had a 90%, 95%, and 99% drop, respectively, from peak levels during the duration of monitoring, and in two patients, Abs fell to prevaccination levels (5%). The use of noninvasive quantitative salivary Ab measurement can allow widespread, cost-effective monitoring of vaccine response.

Is there a difference in student physical activity between a field school and a traditional classroom setting?

OBJECTIVES: We compared the physical activity of nine students participating in an anthropological field school to their activity expenditures in traditional classrooms. We predicted that the students would exhibit higher physical activity during the field school due to the substantial physical requirements associated with the program compared to traditional classroom environments which are frequently more sedentary. METHODS: Participants (n = 9) wore wrist accelerometers for ~23 h each day for 6 days during an anthropological field school and also in a traditional classroom environment. Accelerometers were programed with participant height, weight, age, and sex. Each accelerometer recorded total energy expenditure in kilocalories (kcal), step counts, and time in four physical activity levels (vigorous, moderate, easy, and very easy) between the field school and traditional classroom settings. RESULTS: During the field school portion of the study, participants burned more calories (p < .01), took more steps (p < .0001), and engaged in more moderate and easy exercise (p < .0001). CONCLUSIONS: This study provides insights into the physical benefits of study abroad programs and field schools. Our multi-day accelerometer data revealed significant differences in even relatively low intensities of physical activity. This is particularly pertinent in the United States where sedentary lifestyles are increasing among college students. Taken together, the results underscore the importance of study abroad programs, field schools, and other applied learning opportunities beyond the educational, professional, and social benefits.

Shift in body fat distribution from lower body to upper body among urban Colombian women, 1988-1989 to 2007-2008.

OBJECTIVE: Body fat distribution may be a stronger predictor of metabolic risk than BMI. Yet, few studies have investigated secular changes in body fat distribution in middle-income countries or how those changes vary by socioeconomic status (SES). This study evaluated changes in body fat distribution by SES in Colombia, a middle-income country where BMI is increasing rapidly. DESIGN: We applied factor analysis to previously published data to assess secular changes in adiposity and body fat distribution in cross-sectional samples of urban Colombian women. Anthropometry was used to assess weight, height and skinfolds (biceps, triceps, subscapular, suprailiac, thigh, calf). SETTING: Cali, Colombia. PARTICIPANTS: Women (18-44 years) in 1988-1989 (n 1533) and 2007-2009 (n 577) from three SES groups. RESULTS: We identified an overall adiposity factor, which increased between 1988-1989 and 2007-2008 in all SES groups, particularly in the middle SES group. We also identified arm, leg and trunk adiposity factors. In all SES groups, leg adiposity decreased, while trunk and arm adiposity increased. CONCLUSIONS: Factor analysis highlighted three trends that were not readily visible in BMI data and variable-by-variable analysis of skinfolds: (i) overall adiposity increased between time periods in all SES groups; (ii) the adiposity increase was driven by a shift from lower body to upper body; (iii) the adiposity increase was greatest in the middle SES group. Factor analysis provided novel insights into secular changes and socioeconomic variation in body fat distribution during a period of rapid economic development in a middle-income country.

A Multigene Test Could Cost-Effectively Help Extend Life Expectancy for Women at Risk of Hereditary Breast Cancer.

BACKGROUND: The National Comprehensive Cancer Network recommends that women who carry gene variants that confer substantial risk for breast cancer consider risk-reduction strategies, that is, enhanced surveillance (breast magnetic resonance imaging and mammography) or prophylactic surgery. Pathogenic variants can be detected in women with a family history of breast or ovarian cancer syndromes by multigene panel testing. OBJECTIVES: To investigate whether using a seven-gene test to identify women who should consider risk-reduction strategies could cost-effectively increase life expectancy. METHODS: We estimated effectiveness and lifetime costs from a payer perspective for two strategies in two hypothetical cohorts of women (40-year-old and 50-year-old cohorts) who meet the National Comprehensive Cancer Network-defined family history criteria for multigene testing. The two strategies were the usual test strategy for variants in BRCA1 and BRCA2 and the seven-gene test strategy for variants in BRCA1, BRCA2, TP53, PTEN, CDH1, STK11, and PALB2. Women found to have a pathogenic variant were assumed to undergo either prophylactic surgery or enhanced surveillance. RESULTS: The incremental cost-effectiveness ratio for the seven-gene test strategy compared with the BRCA1/2 test strategy was $42,067 per life-year gained or $69,920 per quality-adjusted life-year gained for the 50-year-old cohort and $23,734 per life-year gained or $48,328 per quality-adjusted life-year gained for the 40-year-old cohort. In probabilistic sensitivity analysis, the seven-gene test strategy cost less than $100,000 per life-year gained in 95.7% of the trials for the 50-year-old cohort. CONCLUSIONS: Testing seven breast cancer-associated genes, followed by risk-reduction management, could cost-effectively improve life expectancy for women at risk of hereditary breast cancer.

No change in energy efficiency in lactation: Insights from a longitudinal study.

OBJECTIVES: Lactation is the most energy-demanding phase of reproduction for human females, but it is still unclear how women in different environments are able to meet this additional energy demand. Previous studies have investigated whether changes in metabolism could have an energy-sparing effect in lactation, with conflicting results. Here, we asked whether increased energy efficiency in physical activity serves as an energy-sparing mechanism in lactation. METHODS: We used a longitudinal design with a control group. Participants were 33 well-nourished, exclusively breastfeeding women and 29 non-pregnant, non-lactating (NPNL) controls aged 32 ± 4 years. Lactating women were measured at peak- and post-lactation. NPNL controls completed a baseline measurement and a follow-up visit. Energy efficiency in physical activity was assessed using a graded submaximal exercise test and calculated as delta efficiency (change in work accomplished over change in energy expended) and gross efficiency (work accomplished over energy expended). RESULTS: There was no significant change in either delta efficiency or gross efficiency from peak to post lactation in lactating women, and no significant difference in delta efficiency between lactating women and NPNL controls at any time period. However, lactating women showed greater between-visit variation in delta efficiency than the NPNL controls. Additionally, 79% of lactating participants lost weight between visits (mean weight loss -3.6 ± 2.3kg), consistent with a mobilization of body tissues to support lactation. CONCLUSION: We found no support for the idea that lactating women undergo an increase in energy efficiency to support the energy costs of lactation.

Local trends in diet in urban Colombia, 1990-1995 to 2008: little evidence of a nutrition transition among low-income women.

OBJECTIVES: To quantify changes in the diets of low-income women in Cali, Colombia between 1990-1995 and 2008, a period of increases in body size, and to situate these changes within national-level trends in food availability, as well as to compare these changes with those expected in countries undergoing a nutrition transition. METHODS: Individual dietary intake was assessed via 24-hour recalls in both 1990-1995 (n = 85) and 2008 (n = 88). Dietary data were analyzed for intake of energy, macronutrients, and specific food items. National-level trends in food availability were evaluated using data from the Food and Agriculture Organization. RESULTS: Total energy and protein intake did not change over time, but in 2008 women consumed proportionally more fat (23.0 vs. 19.1% of calories; P = 0.002) and less carbohydrate (66.5 vs. 71.0% of calories; P < 0.001) than in 1990-1995. The increased fat consumption is attributable to vegetable oils. This increase in vegetable oil consumption, and a decrease in starchy vegetable consumption, fit with both national-level trends in food supply, and the expectations of a nutrition transition. On the other hand, the increased consumption of non-starchy vegetables, and the stability in consumption of added sugars and animal-source proteins was contrary to the expectations of a nutrition transition. CONCLUSIONS: The changes in diet among low-income women in Cali, Colombia between 1990-1995 and 2008 partially match national-level trends in food supply and the theoretical expectations of a nutrition transition, but are nonetheless a localized phenomenon. They do not help explain concurrent changes in body size.

Stable isotopes (carbon, nitrogen, sulfur), diet, and anthropometry in urban Colombian women: investigating socioeconomic differences.

OBJECTIVES: We conducted stable isotope and dietary analyses of women from higher and lower socioeconomic status (SES) groups in Cali, Colombia. The objectives were to test between-group differences in stable isotope, dietary, and anthropometric characteristics, and to evaluate relationships between diet and stable isotope values. METHODS: Hair samples from 38 women (mean age 33.4) from higher and lower SES groups were analyzed for δ(13) C, δ(15) N, and δ(34) S values. Dietary intake was assessed via 24-h recalls. Anthropometric variables measured were body mass index, five body circumferences, and six skinfold thicknesses. RESULTS: Mean δ(13) C and δ(15) N values of the higher SES group (-16.4 and 10.3‰) were significantly greater than those of the lower SES group (-17.2 and 9.6‰; P < 0.01), but mean δ(34) S values did not differ significantly between groups (higher SES: 4.6‰; lower SES: 5.1‰). The higher SES group consumed a greater percentage of protein than the lower SES group (14% vs. 12% of energy; P = 0.03), but the groups did not differ in other dietary characteristics or in anthropometric characteristics. δ(13) C, δ(15) N, and δ(34) S values were not correlated with intake of the dietary items predicted (sugars, animal-source protein, and marine foods, respectively). The lower SES group was more variable in all three stable isotope values (P < 0.05), mirroring a trend toward greater dietary variability in this group. CONCLUSIONS: Stable isotope values revealed a difference between SES groups that was not explained by the dietary data. The relationship between diet and stable isotope composition is complex.

A diagnostic gene profile for molecular subtyping of breast cancer associated with treatment response.

Classification of breast cancer into molecular subtypes maybe important for the proper selection of therapy, as tumors with seemingly similar histopathological features can have strikingly different clinical outcomes. Herein, we report the development of a molecular subtyping profile (BluePrint), that enables rationalization in patient selection for either chemotherapy or endocrine therapy prescription. An 80-Gene Molecular Subtyping Profile (BluePrint) was developed using 200 breast cancer patient specimens and confirmed on four independent validation cohorts (n = 784). Additionally, the profile was tested as a predictor of chemotherapy response in 133 breast cancer patients, treated with T/FAC neoadjuvant chemotherapy. BluePrint classification of a patient cohort that was treated with neoadjuvant chemotherapy (n = 133) shows improved distribution of pathological Complete Response (pCR), among molecular subgroups compared with local pathology: 56% of the patients had a pCR in the Basal-type subgroup, 3% in the MammaPrint Low-risk, Luminal-type subgroup, 11% in the MammaPrint High-risk, Luminal-type subgroup, and 50% in the HER2-type subgroup. The group of genes identifying Luminal-type breast cancer is highly enriched for genes having an Estrogen Receptor binding site proximal to the promoter-region, suggesting that these genes are direct targets of the Estrogen Receptor. Implementation of this profile may improve the clinical management of breast cancer patients, by enabling the selection of patients who are most likely to benefit from either chemotherapy or from endocrine therapy.

Socioeconomic status, stature, and obesity in women: 20-year trends in urban Colombia.

OBJECTIVES: Ongoing social and economic changes in developing countries are associated with increases in body size, and most notably increases in the prevalence of obesity. The social patterning of these changes in terms of socioeconomic status (SES) is not well documented. The aim of this study was to assess the changes in stature, body mass index (BMI) and fatness in adult women in urban Cali, Colombia between 1988-1989 and 2007-2008. METHODS: We compared the results of anthropometric surveys completed in 1988-1989 and 2007-2008 of nonpregnant, nonlactating women, 18-44 years of age. Samples in both studies were stratified by SES. We calculated age-standardized prevalence rates to assess time trends in obesity. Body fatness was assessed by skinfold thicknesses. RESULTS: Stature increased in all SES groups and remained positively associated with SES. BMI increased only in the lower SES group, from 24.4 to 25.9 kg/m(2) and remained negatively associated with SES. The age-standardized prevalence of obesity increased from 7.9 to 17.0% in the lower SES group, but only from 4.5 to 8.2% in the middle SES group, and was unchanged in the upper SES group. Body fatness increased in all SES groups, but only in the upper body. CONCLUSION: The increased stature in all SES groups is indicative of general improvements in socioeconomic conditions. The increased prevalence of obesity in the lower SES groups is in keeping with the findings in other middle-income developing countries.

Evaluation of Quality of Life (BREAST-Q) and Scar Quality (POSAS) after Breast Augmentation.

This study examines the effects of breast augmentation on women who underwent surgery in Germany regarding their quality of life (QOL) and scar quality using patient-reported surveys. The purpose of this study was to determine if there is an increase in women's QOL after surgery compared with preoperative, and to evaluate their postoperative scar quality. Methods: A prospective monocentric study was conducted on 50 women who underwent breast augmentation with nanotextured silicone-filled implants between October 2018 and December 2020. Of these women, 21 (42%) participated in the preoperative survey (BREAST-Q), and 50 (100%) participated in the postoperative survey (BREAST-Q and POSAS). We used the BREAST-Q questionnaire to measure patients' QOL and the Patient and Observer Scar Assessment Scale to determine the scar quality. Results: Psychosocial well-being increased by 34.3 points according to the Q-score, sexual well-being increased by 35.7, and satisfaction with breasts increased by 48.8. Physical well-being decreased by 12 points. The Patient and Observer Scar Assessment Scale mean scores, according to the patient/observer, are 3.8/2.5 for inframammary scars and 4.4/3.1 for periareolar scars. Conclusions: In this study, we discovered that aesthetic breast augmentation with nanotextured silicone-filled breast implants is associated with significantly higher scores for patient satisfaction, which indicates an improvement in women's QOL.

Accumulation of fluorescent advanced glycation end products and carboxymethyl-lysine in human cortical and trabecular bone.

Chemical crosslinks known as advanced glycation end-products (AGEs) are associated with increased bone fracture risk and deteriorated bone mechanical properties. However, measurement of bone AGEs via ex vivo and in vitro methods has been limited to quantification of bulk fluorescent AGEs (fAGEs) and pentosidine only, which is a crosslinking fluorescent AGE. However, a non-crosslinking and non-fluorescent AGE such as carboxymethyl-lysine (CML) is found to be 40-100 times higher in quantity than pentosidine, but only one previous study has reported it in cortical bone, and one study reported it in trabecular bone. In our study, we wanted to investigate if accumulation of CML differs in cortical and trabecular compartments and if they are more strongly associated with bone mechanical properties than with fAGEs. We hypothesized that CML and fAGEs level would be higher in the trabecular compartment and show negative correlations to mechanical properties in cortical and trabecular bone. We obtained human cadaveric cortical and trabecular bone specimens, induced the formation of AGEs via the established in vitro ribosylation method, imaged specimens by microcomputed tomography to assess specimen geometry and microarchitecture, and mechanically tested cortical specimens by cyclic reference point indentation and fracture toughness tests and trabecular specimens by compression tests, followed by measurement of fAGEs and CML. fAGEs were 22 % higher in cortical bone (687 ± 44.8 ng Q/mg collagen) compared to trabecular bone (859 ± 317.1 ng Q/mg collagen), whereas CML levels were found to be 148 % higher in trabecular bone (6189.9 ± 866 ng/mg of protein) compared to cortical bone (924.6 ± 576.3 ng/mg of protein). Pooling the specimens from both the control and ribose groups, Spearman correlation analysis indicated that CML levels, but not fAGEs, are moderately associated with cortical porosity (r = +0.505, p ≤ 0.05) and mechanical properties such indentation depth (r = +0.460, p ≤ 0.05), total indentation depth (r = +0.440, p ≤ 0.05), and average energy dissipated (r = +0.465, p ≤ 0.05) in cortical bone. fAGEs showed a trend towards negative association with crack propagation toughness in cortical bone (r = -0.365, p = 0.055). No significant correlations were observed between CML and microarchitecture or mechanical properties in trabecular bone. CML levels were also associated with fAGEs in cortical bone (r = +0.596, p ≤ 0.05) but not in trabecular bone. Our preliminary findings indicate that CML, a non-crosslinking AGE, may affect bone material and mechanical properties differently than bulk fluorescent AGEs, given the higher accumulation of CML in each bone compartment. This study provides direction to future studies to quantify crosslinking and non-crosslinking AGEs separately as their effect on material and mechanical properties may be different and it would help identify better biomarkers for bone strength prediction.

[Bilateral pedicled gracilis muscle flap and bilateral gluteus muscle flap for multiple-stage reconstruction of vagina, pelvis and perineal region]. / Bilaterale gestielte M. gracilis-Lappenplastik und bilaterale M. gluteus-Rotationslappenplastik zur mehrzeitigen Rekonstruktion der Vagina, des kleinen Beckens sowie der Perinealregion.

Plastic reconstructions of oncological anorectal defects often prove to be very difficult and lead to prolonged hospitalisation due to severe bacterial contamination, neoadjuvant radiotherapy and chemotherapy and difficult anatomical conditions. There is no common standard for plastic reconstruction in such cases. We present a patient diagnosed with distal rectal cancer with infiltration of the anus and vagina, who underwent radical tumour resection of the rectum and anus as well as partial resection of the vagina. A severe necrotising infection occurred post-surgery, which resulted in an extensive defect of the pelvis and perineal region. This article provides a retrospective clinical evaluation and photographic documentation of the reconstruction of the vagina, pelvis and perineal region with a bilateral gracilis and gluteus muscle flap.

The Kinetics of COVID-19 Vaccine Response in a Community Vaccinated Population.

We used a noninvasive electrochemical quantitative assay for IgG antibodies to SARS-CoV-2 S1 in saliva to investigate the kinetics of antibody response in a community-based population who had received either the Pfizer or Moderna mRNA-based vaccines. Samples were received from a total of 97 individuals including a subset of 42 individuals who collected samples twice-weekly for 3 months or longer. In all, 840 samples were collected and analyzed. In all individuals, salivary antibody levels rose sharply in the 2-week period following their second vaccination, with peak antibody levels being at 10-20 days post-vaccination. We observed that 20%, 10% and 2.4% of individuals providing serial samples had a 90%, 95%, and 99% drop respectively from peak levels during the duration of monitoring and two patients fell to pre-vaccination levels (5%). The use of non-invasive quantitative salivary antibody measurement can allow widespread, cost-effective monitoring of vaccine response. ARTICLE SUMMARY LINE: COVID-19 antibodies were measured in saliva and 20% of vaccinated subjects experienced a 90% drop in peak antibody levels over the course of monitoring.

Development and validation of a quantitative, non-invasive, highly sensitive and specific, electrochemical assay for anti-SARS-CoV-2 IgG antibodies in saliva.

Amperial™ is a novel assay platform that uses immobilized antigen in a conducting polymer gel followed by detection via electrochemical measurement of oxidation-reduction reaction between H2O2/Tetrametylbenzidine and peroxidase enzyme in a completed assay complex. A highly specific and sensitive assay was developed to quantify levels of IgG antibodies to SARS-CoV-2 in saliva. After establishing linearity and limit of detection we established a reference range of 5 standard deviations above the mean. There were no false positives in 667 consecutive saliva samples obtained prior to 2019. Saliva was obtained from 34 patients who had recovered from documented COVID-19 or had documented positive serologies. All of the patients with symptoms severe enough to seek medical attention had positive antibody tests and 88% overall had positive results. We obtained blinded paired saliva and plasma samples from 14 individuals. The plasma was analyzed using an EUA-FDA cleared ELISA kit and the saliva was analyzed by our Amperial™ assay. All 5 samples with negative plasma titers were negative in saliva testing. Eight of the 9 positive plasma samples were positive in saliva and 1 had borderline results. A CLIA validation was performed as a laboratory developed test in a high complexity laboratory. A quantitative non-invasive saliva based SARS-CoV-2 antibody test was developed and validated with sufficient specificity to be useful for population-based monitoring and monitoring of individuals following vaccination.

The predictive value of the 70-gene signature for adjuvant chemotherapy in early breast cancer.

Multigene assays have been developed and validated to determine the prognosis of breast cancer. In this study, we assessed the additional predictive value of the 70-gene MammaPrint signature for chemotherapy (CT) benefit in addition to endocrine therapy (ET) from pooled study series. For 541 patients who received either ET (n = 315) or ET + CT (n = 226), breast cancer-specific survival (BCSS) and distant disease-free survival (DDFS) at 5 years were assessed separately for the 70-gene high and low risk groups. The 70-gene signature classified 252 patients (47%) as low risk and 289 (53%) as high risk. Within the 70-gene low risk group, BCSS was 97% for the ET group and 99% for the ET + CT group at 5 years with a non-significant univariate hazard ratio (HR) of 0.58 (95% CI 0.07-4.98; P = 0.62). In the 70-gene high risk group, BCSS was 81% (ET group) and 94% (ET + CT group) at 5 years with a significant HR of 0.21 (95% CI 0.07-0.59; P < 0.01). DDFS was 93% (ET) versus 99% (ET + CT), respectively, in the 70-gene low risk group, HR 0.26 (95% CI 0.03-2.02; P = 0.20). In the high risk group DDFS was 76 versus 88%, HR of 0.35 (95% CI 0.17-0.71; P < 0.01). Results were similar in multivariate analysis, showing significant survival benefit by adding CT in the 70-gene high risk group. A significant and clinically meaningful benefit was observed by adding chemotherapy to endocrine treatment in 70-gene high risk patients. This benefit was not significant in low risk patients, who were at such low risk for recurrence and cancer-related death, that adding CT does not appear to be clinically meaningful.

Development and validation of a highly sensitive and specific electrochemical assay to quantify anti-SARS-CoV-2 IgG antibodies to facilitate pandemic surveillance and monitoring of vaccine response.

Amperial™ is a novel assay platform that uses immobilized antigen in a conductive polymer gel followed by an electrochemical detection. A highly specific and sensitive assay was developed to quantify levels of IgG antibodies to SARS-CoV-2 in saliva. After establishing linearity and limit of detection we established a reference range of 5 standard deviations above the mean. There were no false positives in 667 consecutive saliva samples obtained prior to 2019. Saliva was obtained from 34 patients who had recovered from documented COVID-19 or had documented positive serologies. All of the patients with symptoms severe enough to seek medical attention had positive antibody tests and 88% overall had positive results. We obtained blinded paired saliva and plasma samples from 14 individuals. The plasma was analyzed using an EUA-FDA cleared ELISA kit and the saliva was analyzed by our Amperial™ assay. All 5 samples with negative plasma titers were negative in saliva testing. Eight of the 9 positive plasma samples were positive in saliva and 1 had borderline results. A CLIA validation was performed as a laboratory developed test in a high complexity laboratory. A quantitative non-invasive saliva based SARSCoV-2 antibody test was developed and validated with sufficient specificity to be useful for population-based monitoring and monitoring of individuals following vaccination.

Molecular classification of unknown primary cancer.

The diagnosis of unknown primary carcinoma is often the result of the failure of light microscopy and immunohistochemistry to elucidate the origin of adenocarcinoma or poorly differentiated carcinoma. Recent advances in gene expression profiling using either reverse transcription polymerase chain reaction (RT-PCR) or microarray have enabled researchers to develop expression profiles unique to a wide variety of well-characterized primary cancers and to compare these unique signatures with those from unknown primary cancers. As the gene expression profile is frequently conserved when the tumor metastasizes, it is often possible to analyze a biopsy specimen and genomically identify its tissue of origin. In fact, the overall accuracy of genomic cancer classification in patients with known primary cancers is 80% to 90%. This new system of molecular classification might be considered as "genomic taxonomy." The genomic classification is then available to the pathologist and clinician to aid in both the patient's diagnosis and treatment planning. The impact of this new technology on patient outcomes is currently under study.

[Medical Needling: effect on skin tension and elasticity of hypertrophic burn scars]. / Medical Needling ­ Effekt auf hypertrophe Verbrennungsnarben hinsichtlich der Hautspannung und -elastizität.

BACKGROUND: Burn scars are a serious psychological and physiological problem for affected individuals. Clinical studies and scientific research have shown that Medical Needling improves scar quality in terms of skin elasticity, moisture, transepidermal water loss and erythema. At the same time, patients are confronted with a comparatively low-risk therapy without any postoperative complications. OBJECTIVE: The goal of our study was to examine the influence of Medical Needling on mature hypertrophic scars with regard to skin elasticity and tension. A total of 20 patients with an average age of 34.6 years and second or third-degree burn scars were treated. Scars that were at least 2 years old and had healed by secondary intention met the criteria for inclusion in the study. METHODS: Medical Needling is performed using a roller covered with needles of 3 mm length. The needling device is rolled over the scar in three directions: vertically, horizontally and diagonally. The procedure of puncture leads to multiple micro wounds and intradermal bleeding, which induces the post needling regeneration cascade. The patients were followed up for 12 months postoperatively. The results were evaluated by means of objective and subjective measurement methods. RESULTS: Objective measurements show that Medical Needling improves pathological values of skin tension and elasticity. Depending on the scarring, a reduction in tension or an increased tightness of overstrained and lax skin was recorded. Rigid scars gained vital features and profited from a physiological degree of elasticity. CONCLUSION: Medical Needling proves to be a promising approach for the treatment of mature hypertrophic scars with pathological changes of skin elasticity and tension.

Cost Effectiveness of Sequencing 34 Cancer-Associated Genes as an Aid for Treatment Selection in Patients with Metastatic Melanoma.

OBJECTIVE: To determine whether a next-generation sequencing (NGS) panel of 34 cancer-associated genes would cost-effectively aid in the treatment selection for patients with metastatic melanoma, compared with a single-site BRAF V600 mutation test. METHODS: A decision model was developed to estimate the costs and health outcomes of the two test strategies. The cost effectiveness of these two strategies was analyzed from a payer perspective over a 2-year time horizon with model parameters taken from the literature. RESULTS: In the base case, the gene sequencing panel strategy resulted in a cost of US$120,022 and 0.721 quality-adjusted life years (QALYs) per patient, whereas the single-site mutation test strategy resulted in a cost of US$128,965 and 0.704 QALYs. Thus, the gene sequencing panel strategy cost US$8943 less per patient and increased QALYs by 0.0174 per patient. Sensitivity analyses showed that, compared with the single-site mutation test strategy, the gene sequencing panel strategy had a 90.9% chance of having reduced costs and increased QALYs, with the cost of the gene sequencing panel test having minimal effect on the incremental cost. CONCLUSION: Compared with the single-site mutation test, the use of an NGS panel of 34 cancer-associated genes as an aid in selecting therapy for patients with metastatic melanoma reduced costs and increased QALYs. If the base-case results were applied to the 8900 patients diagnosed with metastatic melanoma in the USA each year, the gene sequencing panel strategy could result in an annual savings of US$79.6 million and a gain of 155 QALYs.