Longitudinal Serum Protein Analysis of Women with a High Risk of Developing Breast Cancer Reveals Large Interpatient Versus Small Intrapatient Variations: First Results from the TESTBREAST Study.

The prospective, multicenter TESTBREAST study was initiated with the aim of identifying a novel panel of blood-based protein biomarkers to enable early breast cancer detection for moderate-to-high-risk women. Serum samples were collected every (half) year up until diagnosis. Protein levels were longitudinally measured to determine intrapatient and interpatient variabilities. To this end, protein cluster patterns were evaluated to form a conceptual basis for further clinical analyses. Using a mass spectrometry-based bottom-up proteomics strategy, the protein abundance of 30 samples was analyzed: five sequential serum samples from six high-risk women; three who developed a breast malignancy (cases) and three who did not (controls). Serum samples were chromatographically fractionated and an in-depth serum proteome was acquired. Cluster analyses were applied to indicate differences between and within protein levels in serum samples of individuals. Statistical analyses were performed using ANOVA to select proteins with a high level of clustering. Cluster analyses on 30 serum samples revealed unique patterns of protein clustering for each patient, indicating a greater interpatient than intrapatient variability in protein levels of the longitudinally acquired samples. Moreover, the most distinctive proteins in the cluster analysis were identified. Strong clustering patterns within longitudinal intrapatient samples have demonstrated the importance of identifying small changes in protein levels for individuals over time. This underlines the significance of longitudinal serum measurements, that patients can serve as their own controls, and the relevance of the current study set-up for early detection. The TESTBREAST study will continue its pursuit toward establishing a protein panel for early breast cancer detection.

Acute pain measured with the modified Bernese Pain Scale for Neonates is influenced by individual contextual factors.

BACKGROUND: Individual contextual factors like gestational age (GA) or previous painful experiences have an influence on neonates' pain responses and may lead to inaccurate pain assessment when not appropriately considered. OBJECTIVES: We set out to determine the influence of individual contextual factors on variability in pain response in neonates, measured with the modified Bernese Pain Scale for Neonates (BPSN), and, if necessary, to incorporate relevant individual factors into a revised version of the BPSN. METHODS: We videotaped 154 full-term and preterm neonates of different GAs during 1-5 capillary heel sticks in their first 14 days of life. For each heel stick, we produced three video sequences: baseline, heel stick, and recovery. The randomized sequences were rated on the BPSN by five blinded nurses. Individual contextual factors were retrospectively extracted from patient charts and from the video recordings. We analysed the data in single and multiple linear mixed models. RESULTS: Premature birth (b = -0.721), caffeine (b = -0.302), and the behavioural states quiet and awake (b = -0.283), active and asleep (b = -0.158), and quiet and asleep (b = -0.498) were associated with changes in behavioural pain scores. Premature birth (b = -0.232), mechanical ventilation (b = -0.196), and duration of the heel stick procedure (b = 0.0004) were associated with changes in physiological pain scores. Premature birth (b = -0.907), Caffeine (b = -0.402), the behavioural states quiet and awake (b = -0.274), and quiet and asleep (b = -0.459), and duration of the heel stick procedure (b = 0.001) were associated with changes in the modified BPSN total scores. CONCLUSIONS: Postmenstrual age, behavioural state, caffeine, and ventilation status have an influence on neonates' pain response and should be incorporated in the revised BPSN to enhance clinical pain assessment in neonates with different GAs. SIGNIFICANCE: We identified individual contextual factors associated with dampened pain response in neonates and will incorporate them into a revised version of the Bernese Pain Scale for Neonates to provide clinicians with a tool they can use to more accurately assess and manage pain in this vulnerable population.

Perinatal mental health care from the user and provider perspective: protocol for a qualitative study in Switzerland.

BACKGROUND: Mental disorders in the perinatal period (PMD) can severely harm women and their children if not detected early and treated appropriately. Even though mental health care is covered by health insurance and is used widely by women in the perinatal period in Switzerland, it is not known if the care provided is meeting the needs of the patients and is efficient in the view of health care professionals. The aim of this study is to identify strengths, gaps and requirements for adequate mental health care in the perinatal period from the perspectives of patients and care providers for a wide range of relevant mental disorders. METHODS: In the qualitative study we conduct (1) semi-structured single interviews with former PMD patients to obtain narratives about their experiences and needs for health care for their condition. Women are included who have been treated for PMD but are mentally stable at the time of the interview (n = 24). We will stratify the sample by 4 clusters of relevant ICD-10 F-diagnoses, covering the most frequent and the most severe mental disorders. We will further stratify the sample based on whether the women already had experience with psychiatric or psychological health care or not before their last episode of PMD. We will also conduct (2) three interprofessional focus groups with health and social care professionals involved in perinatal care, and a health insurance representative. The focus groups will consist of 5-8 professionals. Data collection and thematic analysis will consider Levesque's et al. (2013) conceptual model on access to health care. DISCUSSION: The study will provide fundamental data on the experiences and perspectives about perinatal mental health care from user and provider perspectives. The study will generate the evidence base needed to develop models of integrated, coordinated, patient- and family-centred care that is accessed by women with various types of PMD. TRIAL REGISTRATION: The study was registered on ClinicalTrials.gov in November 2019 under the identifier NCT04185896.

The influence of gestational age in the psychometric testing of the Bernese Pain Scale for Neonates.

BACKGROUND: Assessing pain in neonates is challenging because full-term and preterm neonates of different gestational ages (GAs) have widely varied reactions to pain. We validated the Bernese Pain Scale for Neonates (BPSN) by testing its use among a large sample of neonates that represented all GAs. METHODS: In this prospective multisite validation study, we assessed 154 neonates between 24 2/7 and 41 4/7 weeks GA, based on the results of 1-5 capillary heel sticks in their first 14 days of life. From each heel stick, we produced three video sequences: baseline; heel stick; and, recovery. Five blinded nurses rated neonates' pain responses according to the BPSN. The underlying factor structure of the BPSN, interrater reliability, concurrent validity with the Premature Infant Pain Profile-Revised (PIPP-R), construct validity, sensitivity and specificity, and the relationship between behavioural and physiological indicators were explored. We considered GA and gender as individual contextual factors. RESULTS: The factor analyses resulted in a model where the following behaviours best fit the data: crying; facial expression; and, posture. Pain scores for these behavioural items increased on average more than 1 point during the heel stick phases compared to the baseline and recovery phases (p < 0.001). Among physiological items, heart rate was more sensitive to pain than oxygen saturation. Heart rate averaged 0.646 points higher during the heel stick than the recovery phases (p < 0.001). GA increased along with pain scores: for every additional week of gestation, the average increase of behavioural pain score was 0.063 points (SE = 0.01, t = 5.49); average heart rate increased 0.042 points (SE = 0.01, t = 6.15). Sensitivity and specificity analyses indicated that the cut-off should increase with GA. Modified BPSN showed good concurrent validity with the PIPP-R (r = 0.600-0.758, p < 0.001). Correlations between the modified behavioural subscale and the item heart rate were low (r = 0.102-0.379). CONCLUSIONS: The modified BPSN that includes facial expression, crying, posture, and heart rate is a reliable and valid tool for assessing acute pain in full-term and preterm neonates, but our results suggest that adding different cut-off points for different GA-groups will improve the BPSN's clinical usefulness. TRIAL REGISTRATION: The study was retrospectively registered in the database of Clinical Trial gov. Study ID-number: NCT 02749461 . Registration date: 12 April 2016.

Cosmetic Consequences of Breast-Conserving Treatment for Breast Cancer: Something Worth Talking About.

BACKGROUND: Breast-conserving treatment (BCT) for breast cancer can lead to deformation of the treated breast, resulting in patient dissatisfaction with the final cosmetic outcome. Currently, literature on the specific information needs of patients concerning the cosmetic effects of BCT is lacking. The aim of the present study was to investigate the information needs of breast cancer patients regarding the long-term cosmetic outcome after BCT. SUBJECTS, MATERIALS, AND METHODS: The data from 115 women who had undergone BCT in a general teaching hospital breast cancer unit in The Netherlands were studied. Structured questionnaires and semi-structured interviews were conducted between October 2012 and April 2013. A mixed model of quantitative and qualitative research was used to explore patient-reported information needs. A phenomenological approach was used to analyze the qualitative data. RESULTS: This study shows that women undergoing BCT want to discuss long-term cosmetic effects. Most patients appreciate such information immediately after the diagnosis. Patients indicated that it is also important to pay attention to the cosmetic effects during the follow-up visits, because deformation of the breast can also occur at a later stage. Furthermore, half the patients indicated that they would not likely raise the subject of cosmetic effects of the treatment themselves. CONCLUSION: Breast cancer patients have a need for long-term attention for cosmetic outcome of BCT, which should be tailored during the treatment and follow-up process. IMPLICATIONS FOR PRACTICE: Currently, no literature exists concerning patients' needs for information regarding the cosmetic effects of breast-conserving therapy (BCT). Bringing up the cosmetic effects of BCT by health care professionals does not appear to be a standard part of treatment and follow-up. It is expected that the quality of care and life will be improved by providing information and guidance regarding the cosmetic outcome of BCT within the existing structure of the breast cancer pathway. Discussion and visualization of the cosmetic effects prior to treatment will lead to more realistic expectations, and as a result, secondary interventions, such as partial prostheses and plastic surgery, may be easier to discuss and accept.

Individual contextual factors in the validation of the Bernese pain scale for neonates: protocol for a prospective observational study.

BACKGROUND: The Bernese Pain Scale for Neonates (BPSN) is a multidimensional pain assessment tool that is already widely used in clinical settings in the German speaking areas of Europe. Recent findings indicate that pain responses in preterm neonates are influenced by individual contextual factors, such as gestational age (GA), gender and the number of painful procedures experienced. Currently, the BPSN does not consider individual contextual factors. Therefore, the aim of this study is the validation of the BPSN using a large sample of neonates with different GAs. Furthermore, the influence of individual contextual factors on the variability in pain reactions across GA groups will be explored. The results will be used for a modification of the BPSN to account for individual contextual factors in future clinical pain assessment in neonates. METHODS AND DESIGN: This prospective multisite validation study with a repeated measures design will take place in three university hospital neonatal intensive care units (NICUs) in Switzerland (Bern, Basel and Zurich). To examine the impact of GA on pain responses and their variability, the infants will be stratified into six GA groups ranging from 24 0/7 to 42 0/7. Among preterm infants, 2-5 routine capillary heel sticks within the first 14 days of life, and among full-term infants, two heel sticks during the first days of life will be documented. For each heel stick, measurements will be video recorded for each of three phases: baseline, heel stick, and recovery. The infants' pain responses will be rated according to the BPSN by five nurses who are blinded as to the number of each heel stick and as to the measurement phases. Individual contextual factors of interest will be extracted from patient charts. DISCUSSION: Understanding and considering the influence of individual contextual factors on pain responses in a revised version of the BPSN will help the clinical staff to more appropriately assess pain in neonates, particularly preterm neonates hospitalized in NICUs. Pain assessment is a first step toward appropriate and efficient pain management, which itself is an important factor in later motor and cognitive development in this vulnerable patient population. TRIAL REGISTRATION: The study is registered in the database of Clinical Trial gov. Study ID-number: NCT 02749461 . Registration date: 12 April 2016.

Evaluation of multi-resolution satellite sensors for assessing water quality and bottom depth of Lake Garda.

In this study we evaluate the capabilities of three satellite sensors for assessing water composition and bottom depth in Lake Garda, Italy. A consistent physics-based processing chain was applied to Moderate Resolution Imaging Spectroradiometer (MODIS), Landsat-8 Operational Land Imager (OLI) and RapidEye. Images gathered on 10 June 2014 were corrected for the atmospheric effects with the 6SV code. The computed remote sensing reflectance (Rrs) from MODIS and OLI were converted into water quality parameters by adopting a spectral inversion procedure based on a bio-optical model calibrated with optical properties of the lake. The same spectral inversion procedure was applied to RapidEye and to OLI data to map bottom depth. In situ measurements of Rrs and of concentrations of water quality parameters collected in five locations were used to evaluate the models. The bottom depth maps from OLI and RapidEye showed similar gradients up to 7 m (r = 0.72). The results indicate that: (1) the spatial and radiometric resolutions of OLI enabled mapping water constituents and bottom properties; (2) MODIS was appropriate for assessing water quality in the pelagic areas at a coarser spatial resolution; and (3) RapidEye had the capability to retrieve bottom depth at high spatial resolution. Future work should evaluate the performance of the three sensors in different bio-optical conditions.