BackgroundAssessing 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.MethodsIn 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.ResultsThe 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).ConclusionsThe 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 registrationThe study was retrospectively registered in the database of Clinical Trial gov. Study ID-number: NCT 02749461. Registration date: 12 April 2016.
BackgroundThe 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 designThis 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.DiscussionUnderstanding 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 registrationThe study is registered in the database of Clinical Trial gov. Study ID-number: NCT 02749461. Registration date: 12 April 2016.
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.
Background In the present study, we set out to compare patient reported outcomes with professional judgment about cosmesis after breast-conserving therapy (bct) and to evaluate which items (position of the nipple, color, scar, size, shape, and firmness) correlate best with subjective outcome.Methods Dutch patients treated with bct between 2008 and 2009 were analyzed. Exclusion criteria were prior amputation or bct of the contralateral breast, metastatic disease, local recurrence, or any prior cosmetic breast surgery. Structured questionnaires and standardized six-view photographs were obtained with a minimum of 3 years’ follow-up. Cosmetic outcome was judged by the patients and, based on photographs, by 5 different medical professionals using 3 different scoring systems: the Harvard scale, the Sneeuw questionnaire, and a numeric rating scale. Agreement was scored using the intraclass correlation coefficient (icc). The association between items of the Sneeuw questionnaire and a fair–poor Harvard score was estimated using logistic regression analysis.Results The study included 108 female patients (age: 40–91 years). Based on the Harvard scale, agreement on cosmetic outcome between the professionals was good (icc: 0.78). In contrast, agreement between professionals as a group compared with the patients was found to be fair to moderate (icc range: 0.38–0.50). The items “size” and “shape” were identified as the strongest determinants of cosmetic outcome.Conclusions Cosmetic outcome was scored differently by patients and professionals. Agreement was greater between the professionals than between the patients and the professionals as a group. In general, size and shape were the most prominent items on which cosmetic outcome was judged by patients and professionals alike.
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.
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