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

ABSTRACT: 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.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.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.The study is registered in the database of Clinical Trial gov. Study ID-number: NCT 02749461 . Registration date: 12 April 2016.

SUBMITTER: Cignacco E

PROVIDER: S-EPMC5518104 | biostudies-other | 2017 Jul

REPOSITORIES: biostudies-other

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Project description:BackgroundAntimicrobial resistance is a worldwide challenge for health services and systems alike. To reduce the overuse of antibiotics, multifaceted interventions are often used to achieve sustainable effects. It can be assumed that these effects are influenced by contextual factors. Embedded in the cluster randomized trial ARena (Sustainable reduction of antibiotic-induced antimicrobial resistance), the aim of this present study was to identify contextual factors associated with practitioners' perceptions of antibiotic prescribing in German primary health care.MethodsIn a prospective observational study, data were generated in a three-wave survey study between January 2018 and July 2019. Analysis was performed using logistic regression models. The outcome of interest was the physician perceived impact of participating in the ARena project on decision-making regarding antibiotic prescribing, the independent variables of interest included individual characteristics, intervention arm allocation, primary care network (PCN) environment and characteristics of the medical practice.ResultsForty Six point eight percent (n = 126) of participants indicated to have perceived an impact on their decision-making regarding antibiotic prescribing by participating in the ARena project. Bivariate logistic regression analyses indicated that work experience (odds ratio (OR) 1.05, 95% confidence interval (CI) 1.006-1.103), PCN environment (OR 2.06, 95% CI 1.256-3.363), structural conditions (OR 1.66, 95% CI 1.161-2.371), environment of existing processes (OR 1.46, 95% CI 1.011-2.094), and externally defined general conditions (OR 1.57, 95% CI 1.035-2.378) were associated with physicians' perceived impact of participating in the ARena project on decision-making regarding antibiotic prescribing. In the multivariable logistic regression analysis, only work experience OR 1.05 (95% CI 1.001-1.104) continuously showed a significant influence.ConclusionsThis study indicates that contextual factors at individual, practice, and system level influence physicians' perceptions of antibiotic prescribing. Longer work experience appeared to be a significant influencing factor to be considered in antimicrobial stewardship programs.Trial registrationISRCTN, ISRCTN58150046 (registered 13.09.2017).

Project description:BackgroundPain and fatigue are persistent problems in people with rheumatoid arthritis. Central sensitisation (CS) may contribute to pain and fatigue, even when treatment has controlled inflammatory disease. This study aims to validate a self-report 8-item questionnaire, the Central Aspects of Pain in Rheumatoid Arthritis (CAP-RA) questionnaire, developed to measure central pain mechanisms in RA, and to predict patient outcomes and response to treatment. A secondary objective is to explore mechanisms linking CS, pain and fatigue in people with RA.Methods/designThis is a prospective observational cohort study recruiting 250 adults with active RA in secondary care. The CAP-RA questionnaire, demographic data, medical history, and patient reported outcome measures (PROMs) of traits associated with central sensitization will be collected using validated questionnaires. Quantitative sensory testing modalities of pressure pain detection thresholds, temporal summation and conditioned pain modulation will be indices of central sensitization, and blood markers, swollen joints and ultrasound scans will be indices of inflammation. Primary data collection will be at baseline and 12 weeks. The test-retest reliability of CAP-RA questionnaire will be determined 1 week after the baseline visit. Pain and fatigue data will be collected weekly via text messages for 12 weeks. CAP-RA psychometric properties, and predictive validity for outcomes at 3 months will be evaluated.DiscussionThis study will validate a simple self-report questionnaire against psychophysical indices of central sensitization and patient reported outcome measures of traits associated with CS in a population of individuals with active RA. The application of this instrument in the clinical environment could provide a mechanism-based stratification tool to facilitate the provision of targeted therapy to individuals with pain and fatigue in RA, alongside treatments that target joint inflammation.Trial registrationClinicaltrials.gov NCT04515589 . Date of registration 17 August 2020.

Project description:BACKGROUND:Critically ill patients admitted to intensive care unit (ICU) may suffer from different painful stimuli, but the assessment of pain is difficult because most of them are almost sedated and unable to self-report. Thus, it is important to optimize evaluation of pain in these patients. The main aim of this study was to compare two commonly used scales for pain evaluation: Critical Care Pain Observation Tool (CPOT) and Behavioral Pain Scale (BPS), in both conscious and unconscious patients. Secondary aims were (1) to identifying the most relevant parameters to determine pain scales changes during nursing procedures, (2) to compare both pain scales with visual analog scale (VAS), and (3) to identify the best combination of scales for evaluation of pain in patients unable to communicate. METHODS:In this observational study, 101 patients were evaluated for a total of 303 consecutive observations during 3 days after ICU admission. Measurements with both scales were obtained 1 min before, during, and 20 min after nursing procedures in both conscious (n.41) and unconscious (n.60) patients; furthermore, VAS was recorded when possible in conscious patients only. We calculated criterion and discriminant validity to both scales (Wilcoxon, Spearman rank correlation coefficients). The accuracy of individual scales was evaluated. The sensitivity and the specificity of CPOT and BPS scores were assessed. Kappa coefficients with the quadratic weight were used to reflect agreement between the two scales, and we calculated the effect size to identify the strength of a phenomenon. RESULTS:CPOT and BPS showed a good criterion and discriminant validity (p?<?0.0001). BPS was found to be more specific (91.7 %) than CPOT (70.8 %), but less sensitive (BPS 62.7 %, CPOT 76.5 %). COPT and BPS scores were significantly correlated with VAS (p?<?0.0001). The combination of BPS and CPOT resulted in better sensitivity 80.4 %. Facial expression was the main parameter to determine pain scales changes effect size?=?1.4. CONCLUSIONS:In critically ill mechanically ventilated patients, both CPOT and BPS can be used for assessment of pain intensity with different sensitivity and specificity. The combination of both BPS and CPOT might result in improved accuracy to detect pain compared to scales alone. TRIAL REGISTRATION:NCT01669486.

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

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