Prognostic model for psychological outcomes in ambulatory surgery patients: A prospective study using a structural equation modeling framework.

INTRODUCTION: Surgical procedures are increasingly carried out in a day-case setting. Along with this increase, psychological outcomes have become prominent. The objective was to evaluate prospectively the prognostic effects of sociodemographic, medical, and psychological variables assessed before day-case surgery on psychological outcomes after surgery. METHODS: The study was carried out between October 2010 and September 2011. We analyzed 398 mixed patients, from a randomized controlled trial, undergoing day-case surgery at a university medical center. Structural equation modeling was used to jointly study presurgical prognostic variables relating to sociodemographics (age, sex, nationality, marital status, having children, religion, educational level, employment), medical status (BMI, heart rate), and psychological status associated with anxiety (State-Trait Anxiety Inventory (STAI), Hospital Anxiety and Depression Scale (HADS-A)), fatigue (Multidimensional Fatigue Inventory (MFI)), aggression (State-Trait Anger Scale (STAS)), depressive moods (HADS-D), self-esteem, and self-efficacy. We studied psychological outcomes on day 7 after surgery, including anxiety, fatigue, depressive moods, and aggression regulation. RESULTS: The final prognostic model comprised the following variables: anxiety (STAI, HADS-A), fatigue (MFI), depression (HADS-D), aggression (STAS), self-efficacy, sex, and having children. The corresponding psychological variables as assessed at baseline were prominent (i.e. standardized regression coefficients ≥ 0.20), with STAI-Trait score being the strongest predictor overall. STAI-State (adjusted R2 = 0.44), STAI-Trait (0.66), HADS-A (0.45) and STAS-Trait (0.54) were best predicted. CONCLUSION: We provide a prognostic model that adequately predicts multiple postoperative outcomes in day-case surgery. Consequently, this enables timely identification of vulnerable patients who may require additional medical or psychological preventive treatment or-in a worst-case scenario-could be unselected for day-case surgery.

Motivation, treatment engagement and psychosocial outcomes in outpatients with severe mental illness: a test of Self-Determination Theory.

Currently, it is unclear whether Self-Determination Theory (SDT) applies to the mental health care of patients with severe mental illness (SMI). Therefore, the current study tested the process model of SDT in a sample of outpatients with SMI. Participants were 294 adult outpatients with a primary diagnosis of a psychotic disorder or a personality disorder and their clinicians (n = 57). Structural equation modelling was used to test the hypothesized relationships between autonomy support, perceived competence, types of motivation, treatment engagement, psychosocial functioning and quality of life at two time points and across the two diagnostic groups. The expected relations among the SDT variables were found, but additional direct paths between perceived competence and clinical outcomes were needed to obtain good model fit. The obtained process model was found to be stable across time and different diagnostic patient groups, and was able to explain 18% to 36% of variance in treatment engagement, psychosocial functioning and quality of life. It is concluded that SDT can be a useful basis for interventions in the mental health care for outpatients with SMI. Additional experimental research is needed to confirm the causality of the relations between the SDT constructs and their ability to influence treatment outcomes.

Do determinants of burden and emotional distress in dementia caregivers change over time?

OBJECTIVES: Caring for a patient with dementia is a real challenge and can have considerable psychological consequences in the long run. Many caregivers, mostly relatives, feel highly burdened. To develop effective caregiver support to prevent caregivers from getting overburdened, insight is needed into the determinants of burden. The objective of this study is to explore which patient and caregiver characteristics determine the different kinds of caregiver burden over time, both in the short and in the long run. METHOD: The study was longitudinal. Data on patients and caregivers, general burden and emotional distress were collected at three times: at baseline, at the end of treatment and at nine months. The study was conducted in a psychiatric skilled nursing home with a unit for integrative reactivation and rehabilitation (IRR) and at different sites of home-/day care, assisted living arrangements and nursing home wards (usual care). RESULTS: General burden is shown to be determined by severity of patient's neuropsychiatric symptoms, caregiver's sense of competence, health-related quality of life. Emotional distress is determined by severity of patient's neuropsychiatric symptoms, caregiver's sense of competence, high affiliation and patient gender. CONCLUSION: In preventing or treating caregiver burden, professional interventions need to aim specifically at diminishing the neuropsychiatric symptoms in dementia patients and improving the sense of competence in caregivers.

Implication of UGT2B15 Genotype Polymorphism on Postoperative Anxiety Levels in Patients Receiving Lorazepam Premedication.

BACKGROUND: Lorazepam is used as premedication for its anxiolytic properties. The UGT2B15 genotype is of importance for the metabolism of lorazepam. The clinical effect of genetic polymorphisms in UGT2B15 genotype on the treatment of anxiety levels in same-day surgery patients receiving lorazepam, however, is unknown. METHODS: Three hundred ninety-eight same-day surgery patients of mixed sex (from a previous double-blinded randomized controlled trial who were assigned to either lorazepam [n = 198] or placebo [n = 200]) were assessed for the UGT2B15*2 variant allele. Anxiety was measured preoperatively and postoperatively by the State part of the State-Trait Anxiety Inventory. The difference between these 2 measurements served as outcome of the study. Analysis of variance was used to assess the State part of the State-Trait Anxiety Inventory difference for interactions among the following factors: UGT2B15 genotype status, treatment condition (lorazepam or placebo), patient sex, and preoperative anxiety score. RESULTS: The anxiety difference was complex in that the interaction of lorazepam and UGT2B15 genotype status also was dependent on the joint effect of patient sex and preoperative anxiety score (F = 7.15, P = .008). Further exploration showed clinical relevant results in patients with high preoperative anxiety scores. Striking was that females with high preoperative anxiety scores and genetically reduced lorazepam glucuronidation (UGT2B15*2 homozygotes) showed more postoperative anxiety reduction than males with the same genotype. CONCLUSIONS: UGT2B15 genotype contributes to postoperative anxiety reduction after lorazepam premedication. Future research that focuses on patients with high preoperative anxiety scores could help to gain a deeper understanding in the clinical relevance of the interaction between lorazepam and UGT2B15 genotype on postoperative anxiety levels.

Clinical prediction model to identify vulnerable patients in ambulatory surgery: towards optimal medical decision-making.

BACKGROUND: Ambulatory surgery patients are at risk of adverse psychological outcomes such as anxiety, aggression, fatigue, and depression. We developed and validated a clinical prediction model to identify patients who were vulnerable to these psychological outcome parameters. METHODS: We prospectively assessed 383 mixed ambulatory surgery patients for psychological vulnerability, defined as the presence of anxiety (state/trait), aggression (state/trait), fatigue, and depression seven days after surgery. Three psychological vulnerability categories were considered-i.e., none, one, or multiple poor scores, defined as a score exceeding one standard deviation above the mean for each single outcome according to normative data. The following determinants were assessed preoperatively: sociodemographic (age, sex, level of education, employment status, marital status, having children, religion, nationality), medical (heart rate and body mass index), and psychological variables (self-esteem and self-efficacy), in addition to anxiety, aggression, fatigue, and depression. A prediction model was constructed using ordinal polytomous logistic regression analysis, and bootstrapping was applied for internal validation. The ordinal c-index (ORC) quantified the discriminative ability of the model, in addition to measures for overall model performance (Nagelkerke's R (2) ). RESULTS: In this population, 137 (36%) patients were identified as being psychologically vulnerable after surgery for at least one of the psychological outcomes. The most parsimonious and optimal prediction model combined sociodemographic variables (level of education, having children, and nationality) with psychological variables (trait anxiety, state/trait aggression, fatigue, and depression). Model performance was promising: R (2)  = 30% and ORC = 0.76 after correction for optimism. CONCLUSION: This study identified a substantial group of vulnerable patients in ambulatory surgery. The proposed clinical prediction model could allow healthcare professionals the opportunity to identify vulnerable patients in ambulatory surgery, although additional modification and validation are needed. (ClinicalTrials.gov number, NCT01441843).

Effectiveness of benzodiazepine premedication on recovery in day-case surgery: a systematic review with meta-analysis.

INTRODUCTION: Benzodiazepines are frequently used as a premedication. In day-case surgery, anesthetists are reluctant to administer benzodiazepines preoperatively for reasons of delayed recovery. However, premedication with benzodiazepines might be beneficial regarding postoperative somatic symptoms/complaints (i.e. time to recovery and postoperative side effects) and psychological phenomena. EVIDENCE ACQUISITION: A systematic review with meta-analysis was performed using all important search engines. Study methodological quality was assessed using risk of bias tables. Mean differences (MD) and odds ratios (OR) were used for continuous data (time to recovery and psychological phenomena) and categorical data (postoperative somatic symptoms) respectively. Random effects modelling was applied. Nineteen studies were included. Overall time to recovery was significantly delayed in patients receiving benzodiazepines (MD 1.75; 95% CI 0.82 to 2.69) although time to discharge was not significantly affected. Postoperative side effects were significantly reduced in patients receiving benzodiazepines (OR 0.47; 95% CI 0.36 to 0.63). Regarding psychological outcome, only anxiety could be statistically analyzed showing no statistical difference (MD 1.47; 95% CI -1.01 to 3.96). EVIDENCE SYNTHESIS: Although overall time to recovery was significantly prolonged by benzodiazepine premedication, withholding premedication in day-case surgery patients is not justified for such reason, as time to discharge was not negatively affected. Furthermore, benzodiazepines show to have beneficial effects on postoperative side effects. CONCLUSIONS: For a firm conclusion regarding psychological phenomena, more research is needed. Anaesthetists should take into account this new evidence when they apply their premedication regime in day-case surgery.

Different Perspectives of Clinicians and Patients with Severe Mental Illness on Motivation for Treatment.

The present study assessed motivation for engaging in treatment as rated by clinicians (n = 57) and patients with severe mental illness (SMI, n = 294) using measures based on three different motivation theories. Questionnaires were derived from self-determination theory, the transtheoretical model and the integral model of treatment motivation. It was investigated to which extent clinicians of patients with SMI were able to estimate their patient's perspective on motivation for engaging in treatment, to which extent they agreed on the patient's motivation and which factors were associated with estimation and agreement on treatment motivation. It was found that clinicians were poorly to moderately capable of estimating their patient's type of motivation and readiness for change. Further, agreement on the level of motivation between patients and clinicians was moderate. These findings were consistent across diagnostic groups (psychotic and personality disorders). A higher quality therapeutic relationship was generally associated with higher clinician-rated motivation. The patient's ethnicity and socially desirable responding were factors that differentiated between scales of different motivation theories. It is concluded that patients with SMI and their clinicians have different perceptions on the patient's motivation for engaging in psychiatric treatment, regardless of the theoretical framework that is used to measure motivation. The findings imply that a negotiated approach is needed where both perceptions of clinicians and patients on motivation for treatment are considered to ensure effective mental health interventions. Copyright © 2015 John Wiley & Sons, Ltd. KEY PRACTITIONER MESSAGE: Clinicians show poor to moderate capability in estimating how patients perceive their motivation for engaging in treatment, especially so when the patient's motives revolve around feelings of shame and guilt. Clinicians generally give higher motivation ratings for patients where they experience a higher quality therapeutic relationships with, whereas-depending on the scale that is used to measure motivation-they give lower ratings to patients who respond in socially desirable ways and to ethnic minority patients. As patients with SMI and their clinicians have different perceptions on the patient's motivation for engaging in psychiatric treatment (regardless of the theoretical framework that is used to assess motivation), this implies that a negotiated approach is needed where both perceptions of clinicians and patients on motivation for treatment are considered to ensure effective mental health interventions.

The effects of motivation feedback in patients with severe mental illness: a cluster randomized controlled trial.

OBJECTIVE: To evaluate the effectiveness of providing clinicians with regular feedback on the patient's motivation for treatment in increasing treatment engagement in patients with severe mental illness. DESIGN: cluster randomized controlled trial (Dutch Trials Registry NTR2968). PARTICIPANTS: adult outpatients with a primary diagnosis of a psychotic disorder or a personality disorder and their clinicians, treated in 12 community mental health teams (the clusters) of two mental health institutions in the Netherlands. INTERVENTIONS: monthly motivation feedback (MF) generated by clinicians additional to treatment as usual (TAU) and TAU by the community mental health teams. PRIMARY OUTCOME: treatment engagement at patient level, assessed at 12 months by clinicians. RANDOMIZATION: teams were allocated to MF or TAU by a computerized randomization program that randomized each team to a single treatment by blocks of varying size. All participants within these teams received similar treatment. Clinicians and patients were not blind to treatment allocation at the 12-month assessment. RESULTS: The 294 randomized patients (148 MF, 146 TAU) and 57 clinicians (29 MF, 28 TAU) of 12 teams (6 MF, 6 TAU) were analyzed according to the intention-to-treat principle. No statistically significant differences between treatment groups on treatment engagement were found (adjusted mean difference =0.1, 95% confidence interval =-2.2 to 2.3, P=0.96, d=0). Preplanned ancillary analyses showed statistically significant interaction effects between treatment group and primary diagnosis on treatment motivation and quality of life (secondary outcomes), which were beneficial for patients with a primary diagnosis of a personality disorder but not for those with a psychotic disorder. There were no reports of adverse events. CONCLUSION: The current findings imply that monitoring and discussing the patient's motivation is insufficient to improve motivation and treatment engagement, and suggests that more elaborate interventions for severe mental illness patients are needed.

Long-term survival after resection for non-pancreatic periampullary cancer followed by adjuvant intra-arterial chemotherapy and concomitant radiotherapy.

BACKGROUND: There is no consensus regarding the optimal adjuvant treatment after resection of non-pancreatic periampullary adenocarcinoma (NPPC; distal common bile duct, ampulla, duodenum). OBJECTIVES: The present study was conducted to evaluate the impacts on longterm survival and recurrence of adjuvant intra-arterial chemotherapy (IAC) and concomitant radiotherapy (RT) in patients submitted to resection for NPPC or pancreatic ductal adenocarcinoma (PDAC) in a randomized controlled trial. METHODS: A total of 120 patients with PDAC (n = 62) or NPPC (n = 58) were prestratified at a ratio of 1:1 for tumour origin and randomized. Half of these patients were treated with adjuvant IAC/RT and the other half were treated with surgery alone. Follow-up was completed for all patients up to 5 years after resection or until death. RESULTS: There was no survival benefit in either the whole group (primary endpoint) or the PDAC group after IAC/RT. In the NPPC group, longterm survival was observed in 10 patients in the IAC/RT group and five patients in the control group: median survival was 37 months and 28 months, respectively. The occurrence of liver metastases was reduced by IAC/RT from 57% to 29% (P = 0.038). Cox regression analysis revealed a substantial effect of IAC/RT on survival (hazard ratio: 0.44, 95% confidence interval 0.23-0.83; P = 0.011). CONCLUSIONS: This longterm analysis shows that median and longterm survival were improved after IAC/RT in patients with NPPC, probably because of the effective and sustained reduction of liver metastases. The present results illustrate that NPPC requires an adjuvant approach distinct from that in pancreatic cancer and indicate that further investigation of this issue is warranted.

Minor impact of multiple psychiatric symptoms on quality of life (EQ5D) in psychogeriatric patients: a clinical-empirical structural modeling approach.

BACKGROUND: The relationship of clinical variables for cognitive functioning and other variables such as multiple neuropsychiatric symptoms and quality of life are usually analyzed bivariately and multivariately. In randomized controlled trials analyses are mostly performed on individual outcome variables. To unravel interdependencies of determinants and outcome variables, Structural Equation Modeling (SEM) was applied. METHODS: Using SEM, we explored interdependencies of clinical determinants (MMSE, BI, and NPI-sum severity) and quality of life (EQ5D) in psychogeriatric patients (including dementia) suffering from cognitive problems and multiple neuropsychiatric symptoms. RESULTS: MMSE and BI showed direct and indirect impact on EQ5D, but the association with NPI-sum severity was minor. The identified model showed that R(2) of EQ5D varied from 0.21 to 0.48. DISCUSSION: This clinical-empirical study showed that SEM could be utilized to unravel and identify a model of complex direct and indirect effects of MMSE and BI on EQ5D. In relation to NPI-sum severity, however, the validity of EQ5D seemed insufficient in psychogeriatric patients. Consequently, the cost-benefit analyses and cost-effectiveness analyses using quality-adjusted life-year measures of an intervention in psychogeriatric patients with multiple neuropsychiatric symptoms, based on EQ5D, are considered questionable. Construction of a quality of life instrument that is more sensitive with regard to multiple neuropsychiatric symptoms in psychogeriatric patients is highly recommended.

Multivariate models of subjective caregiver burden in dementia: a systematic review.

BACKGROUND: Burden in dementia caregivers is a complex and multidimensional construct. Several models of burden and other representations of burden like depression or mental health are described in literature. To clarify the state of science, we systematically reviewed complex models that include both patient and caregiver determinants of caregiver burden. OBJECTIVE: A review of determinant models of caregiver burden. DESIGN: Systematic review. DATA SOURCES: Electronic databases PubMed, PsycInfo and EMbase were searched in December 2013. STUDY SELECTION AND ANALYSIS: Research studies with quantitative outcome measures of caregiver burden or burden-related concepts, including both patient and caregiver functional characteristics as determinants. We categorized the determinant variables in the models and calculated the percentages of proven determinants within each category. RESULTS: We found 32 studies with burden models and 24 depression and mental health models. Patient behavioral problems, caregiver coping and personality traits and competence are most consistent determinants of caregiver burden, depression and mental health. Behavioral problems are more significant than cognitive disorders or lack of self-care. Of all measured caregiver personality traits, neuroticism has the strongest impact on caregiver burden. Regarding caregiver competences, feeling competent or enjoying higher self-efficacy in general diminish caregiver burden and promote caregiver mental health.

Measures of motivation for psychiatric treatment based on self-determination theory: psychometric properties in Dutch psychiatric outpatients.

Self-determination theory is potentially useful for understanding reasons why individuals with mental illness do or do not engage in psychiatric treatment. The current study examined the psychometric properties of three questionnaires based on self-determination theory-The Treatment Entry Questionnaire (TEQ), Health Care Climate Questionnaire (HCCQ), and the Short Motivation Feedback List (SMFL)-in a sample of 348 Dutch adult outpatients with primary diagnoses of mood, anxiety, psychotic, and personality disorders. Structural equation modeling showed that the empirical factor structures of the TEQ and SMFL were adequately represented by a model with three intercorrelated factors. These were interpreted as identified, introjected, and external motivation. The reliabilities of the Dutch TEQ, HCCQ, and SMFL were found to be acceptable but can be improved on; congeneric estimates ranged from 0.66 to 0.94 depending on the measure and patient subsample. Preliminary support for the construct validities of the questionnaires was found in the form of theoretically expected associations with other scales, including therapist-rated motivation and treatment engagement and with legally mandated treatment. Additionally, the study provides insights into the relations between measures of motivation based on self-determination theory, the transtheoretical model and the integral model of treatment motivation in psychiatric outpatients with severe mental illness.

Economic evaluation alongside a single RCT of an integrative psychotherapeutic nursing home programme.

BACKGROUND: There is an 80% prevalence of two or more psychiatric symptoms in psychogeriatric patients. Multiple psychiatric symptoms (MPS) have many negative effects on quality of life of the patient as well as on caregiver burden and competence. Irrespective of the effectiveness of an intervention programme, it is important to take into account its economic aspects. METHODS: The economic evaluation was performed alongside a single open RCT and conducted between 2001 and 2006. The patients who met the selection criteria were asked to participate in the RCT. After the patient or his caregiver signed a written informed consent form, he was then randomly assigned to either IRR or UC.The costs and effects of IRR were compared to those of UC. We assessed the cost-utility of IRR as well as the cost-effectiveness of both conditions. Primary outcome variable: severity of MPS (NPI) of patients; secondary outcome variables: general caregiver burden (CB) and caregiver competence (CCL), quality of life (EQ5D) of the patient, and total medical costs per patient (TiC-P). Cost-utility was evaluated on the basis of differences in total medical costs). Cost-effectiveness was evaluated by comparing differences of total medical costs and effects on NPI, CB and CCL (Incremental Cost-Effectiveness Ratio: ICER). CEAC-analyses were performed for QALY and NPI-severity. All significant testing was fixed at p<0.05 (two-tailed). The data were analyzed according to the intention-to-treat (ITT)-principle. A complete cases approach (CC) was used. RESULTS: IRR turned out to be non-significantly, 10.5% more expensive than UC (€ 36 per day). The number of QALYs was 0.01 higher (non-significant) in IRR, resulting in € 276,290 per QALY. According to the ICER-method, IRR was significantly more cost-effective on NPI-sum-severity of the patient (up to 34%), CB and CCL (up to 50%), with ICERs varying from € 130 to € 540 per additional point of improvement. CONCLUSIONS: No significant differences were found on QALYs. In IRR patients improved significantly more on severity of MPS, and caregivers on general burden and competence, with incremental costs varying from € 130 to € 540 per additional point of improvement. The surplus costs of IRR are considered acceptable, taking into account the high societal costs of suffering from MPS of psychogeriatric patients and the high burden of caregivers. The large discrepancy in economic evaluation between QALYs (based on EQ5D) and ICERs (based on clinically relevant outcomes) demands further research on the validity of EQ5D in psychogeriatric cost-utility studies. (Trial registration nr.: ISRCTN 38916563; December 2004).

Psychometric evaluation of the Sophia Observation withdrawal symptoms scale in critically ill children.

OBJECTIVE: The Sophia Observation withdrawal Symptoms scale is an instrument for screening benzodiazepine and opioid withdrawal syndrome in pediatric critical care patients. The objectives of this study were to establish cutoff scores and to test sensitivity to change. Second, risk factors for withdrawal syndrome were explored. DESIGN: Prospective observational study with repeated measures. SETTING: Level IV ICU at a university children's hospital. PATIENTS: A total of 154 children with median age 5 months (interquartile range, 0-42 mo) who received continuous infusion of benzodiazepines and/or opioids for 5 or more days. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Nurses repeatedly applied the Sophia Observation withdrawal Symptoms scale and the Numeric Rating Scale withdrawal when children were weaned off benzodiazepines and opioids. The latter represents the nurse's expert opinion. We analyzed 3,754 paired assessments; the median number per child was 15 (interquartile range, 7-31) over a median of 5 days (interquartile range, 3-11 d). Sensitivity and specificity were 0.83 and 0.93, respectively, for the Sophia Observation withdrawal Symptoms scale cutoff score of 4 or higher against a Numeric Rating Scale-withdrawal score of 4 or higher. Sensitivity to change was determined by comparing 156 Sophia Observation withdrawal Symptoms scale assessments (n = 51 patients) before and after additional sedatives or opioids. Multilevel regression analysis showed a mean decline of 1.5 points (at score range 0-15) after intervention (p < 0.0001). Logistic regression analysis identified duration of preweaning of midazolam, duration of weaning of midazolam, duration of preweaning of morphine, duration of weaning of morphine, and number of additional sedatives/opioids as statistically significant risk factors for withdrawal syndrome in these children. CONCLUSIONS: The Sophia Observation withdrawal Symptoms scale is a valid tool with good psychometric properties to assess withdrawal symptoms in PICU patients.

The shortened EMpowerment of PArents in THe Intensive Care 30 questionnaire adequately measured parent satisfaction in pediatric intensive care units.

OBJECTIVE: To shorten and validate the EMpowerment of PArents in THe Intensive Care (EMPATHIC) questionnaire of optimal length to measure satisfaction of parents whose child has been admitted to pediatric intensive care units (PICUs). STUDY DESIGN AND SETTING: A total of 3,354 (55.4%) parents in eight PICUs completed the 65-item EMPATHIC questionnaire. Multiple regression analysis was applied to evaluate the statistical performances. The reduced domains were intercorrelated by the Pearson's product moment correlation coefficient. The robustness of the findings was evaluated by adjusted R(2) for internal cross-validations. Reliability was assessed by internal consistency. RESULTS: Multiple regression analysis based on statistical redundancy established the optimal length at 30 items over five different domains: information (5 items), care and cure (8 items), organization (5 items), parental participation (6 items), and professional attitude (6 items). The explained variances of the domains ranged from 85% to 93%. The domains of the full and optimal version showed strong correlations (r = 0.92-0.97). Cross-validation among eight centers and across time provided adjusted R(2) values on domain level between 85% and 95%. The reliability estimates of the domains, assessed by Cronbach's α, varied between 0.73 and 0.93. CONCLUSION: By statistically eliminating the redundant items, the EMPATHIC questionnaire could be reduced from 65 to 30 items.

Lorazepam does not improve the quality of recovery in day-case surgery patients: a randomised placebo-controlled clinical trial.

BACKGROUND: In day-case surgery, the effects of the anxiolytic lorazepam as premedication on the quality of postoperative recovery are unknown. OBJECTIVE: To evaluate whether lorazepam as a premedication beneficially affects quality of recovery (primary outcome) and psychological manifestations (secondary outcome) after day-case surgery. DESIGN: A randomised, double-blind, placebo-controlled clinical trial. SETTING: Single tertiary centre. INCLUSION CRITERIA: day-case surgery; age at least 18 years. EXCLUSION CRITERIA: insufficient knowledge of the Dutch language; intellectual disability; ophthalmology surgery; extracorporeal shock wave lithotripsy; endoscopy; botulinum toxin A treatment; abortion; chronic pain treatment; preceding use of psychopharmaceuticals; contraindication to lorazepam. INTERVENTION: Lorazepam (1 to 1.5 mg) intravenously vs. NaCl 0.9% as a premedication prior to surgery. MAIN OUTCOME MEASURE: Quality of Recovery-40 (QoR-40) score. SECONDARY OUTCOMES: State-Trait Anxiety Inventory (STAI-State/Trait); State-Trait Anger Scale (STAS-State/Trait); Multidimensional Fatigue Inventory (MFI); Hospital Anxiety and Depression Scale (HADS). Timing of evaluation: T0: preoperatively (all scales); T1: before discharge (STAI-State/Trait); T2: first postoperative working day (QoR-40); T3: 7th day after surgery (all scales). Robust regression analysis was applied. Statistical analyses were adjusted for the corresponding baseline value and sex. RESULTS: Four hundred patients were randomised; 398 patients were analysed. Postoperative mean QoR-40 scores were similar in both groups at T2 (174.5 vs. 176.4, P = 0.34) and T3 (172.8 vs.176.3, P = 0.38). Postoperative mean STAI-State/Trait scores decreased less in the group with lorazepam at T1 (32.3 vs. 29.3, P < 0.0001; 32.7 vs. 30.8, P = 0.0002). STAI-Trait and HADS-Anxiety decreased less in the group with lorazepam at T3 (31.1 vs. 30.0; P = 0.03, 3.3 vs. 2.5, P = 0.003). STAS-State increased in the group with lorazepam at T3 (10.8 vs. 10.3, P = 0.04). CONCLUSION: In day-case surgery, lorazepam as a premedication did not improve quality of recovery. Furthermore, this premedication may delay the decrease in postoperative anxiety and aggression. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01441843.

Executive function and IQ predict mathematical and attention problems in very preterm children.

Objective of this study was to examine the impact of executive function (EF) on mathematical and attention problems in very preterm (gestational age ≤ 30 weeks) children. Participants were 200 very preterm (mean age 8.2 ± 2.5 years) and 230 term children (mean age 8.3 ± 2.3 years) without severe disabilities, born between 1996 and 2004. EFs assessed included verbal fluency, verbal working memory, visuospatial span, planning, and impulse control. Mathematics was assessed with the Dutch Pupil Monitoring System and parents and teachers rated attention problems using standardized behavior questionnaires. The impact of EF was calculated over and above processing speed indices and IQ. Interactions with group (very preterm versus term birth status) were examined. Analyses were conducted separately for two subsamples: children in preschool and children in primary school. Very preterm children performed poorer on tests for mathematics and had more parent and teacher rated attention problems than term controls (ß(s)>.11, P(s)<.01). IQ contributed unique variance to mathematics in preschool and in primary school (ß(s)>.16, P(s)<.007). A significant interaction of group with IQ (ß = -. 24, P = .02) showed that IQ contributed unique variance to attention problems as rated by teachers, but that effects were stronger for very preterm than for term infants. Over and above IQ, EF contributed unique variance to mathematics in primary school (ß = .13, P<.001), to parent rated inattention in preschool and in primary school (ß(s)>-.16, P(s)<.04), and to teacher rated inattention in primary school (ß = -.19; ß = .19, P(s)<.009). In conclusion, impaired EF is, over and above impaired IQ, an important predictor for poor mathematics and attention problems following very preterm birth.

Effect of intravenous paracetamol on postoperative morphine requirements in neonates and infants undergoing major noncardiac surgery: a randomized controlled trial.

IMPORTANCE: Continuous morphine infusion as standard postoperative analgesic therapy in young infants is associated with unwanted adverse effects such as respiratory depression. OBJECTIVE: To determine whether intravenous paracetamol (acetaminophen) would significantly (>30%) reduce morphine requirements in neonates and infants after major surgery. DESIGN, SETTING, AND PATIENTS: Single-center, randomized, double-blind study conducted in a level 3 pediatric intensive care unit in Rotterdam, The Netherlands. Patients were 71 neonates or infants younger than 1 year undergoing major thoracic (noncardiac) or abdominal surgery between March 2008 and July 2010, with follow-up of 48 hours. INTERVENTIONS: All patients received a loading dose of morphine 30 minutes before the end of surgery, followed by continuous morphine or intermittent intravenous paracetamol up to 48 hours postsurgery. Infants in both study groups received morphine (boluses and/or continuous infusion) as rescue medication on the guidance of the validated pain assessment instruments. MAIN OUTCOME MEASURES: Primary outcome was cumulative morphine dose (study and rescue dose). Secondary outcomes were pain scores and morphine-related adverse effects. RESULTS: The cumulative median morphine dose in the first 48 hours postoperatively was 121 (interquartile range, 99-264) µg/kg in the paracetamol group (n = 33) and 357 (interquartile range, 220-605) µg/kg in the morphine group (n = 38), P < .001, with a between-group difference that was 66% (95% CI, 34%-109%) lower in the paracetamol group. Pain scores and adverse effects were not significantly different between groups. CONCLUSION AND RELEVANCE: Among infants undergoing major surgery, postoperative use of intermittent intravenous paracetamol compared with continuous morphine resulted in a lower cumulative morphine dose over 48 hours. TRIAL REGISTRATION: trialregister.nl Identifier: NTR1438.

Impact of bronchiectasis and trapped air on quality of life and exacerbations in cystic fibrosis.

Cystic fibrosis (CF) is primarily characterised by bronchiectasis and trapped air on chest computed tomography (CT). The revised Cystic Fibrosis Questionnaire respiratory symptoms scale (CFQ-R RSS) measures health-related quality of life. To validate bronchiectasis, trapped air and CFQ-R RSS as outcome measures, we investigated correlations and predictive values for pulmonary exacerbations. CF patients (aged 6-20 years) underwent CT, CFQ-R RSS and 1-year follow-up. Bronchiectasis and trapped air were scored using the CF-CT scoring system. Correlation coefficients and backward multivariate modelling were used to identify predictors of pulmonary exacerbations. 40 children and 32 adolescents were included. CF-CT bronchiectasis (r = -0.38, p<0.001) and CF-CT trapped air (r = -0.35, p = 0.003) correlated with CFQ-R RSS. Pulmonary exacerbations were associated with: bronchiectasis (rate ratio 1.10, 95% CI 1.02-1.19; p = 0.009), trapped air (rate ratio 1.02, 95% CI 1.00-1.05; p = 0.034) and CFQ-R RSS (rate ratio 0.95, 95% CI 0.91-0.98; p = 0.002). The CFQ-R RSS was an independent predictor of pulmonary exacerbations (rate ratio 0.96, 95% CI 0.94-0.97; p<0.001). Bronchiectasis, trapped air and CFQ-R RSS were associated with pulmonary exacerbations. The CFQ-R RSS was an independent predictor. This study further validated bronchiectasis, trapped air and CFQ-R RSS as outcome measures in CF.

Long-term psychological distress in women at risk for hereditary breast cancer adhering to regular surveillance: a risk profile.

BACKGROUND: Some women at risk for hereditary breast cancer are at increased risk of psychological distress. In order to tailor support for individual women, the availability of a tool enabling the identification of psychologically vulnerable women at an early stage is warranted. The objectives of this study were (1) to explore long-term psychological distress in women at risk for hereditary breast cancer adhering to regular surveillance, and (2) to identify women being vulnerable for long-term psychological distress, defined in terms of a multifactorial risk profile. METHODS: General distress and cancer-related distress were assessed at baseline (T0) and after 5-8 years (T1) in 197 high-risk women adhering to breast cancer surveillance. Coping styles, occurrence of breast cancer in the family of origin, breast cancer risk perception, and frequency of breast self-examination, as assessed at T0, were examined as predictor variables for long-term distress (T1). RESULTS: Across time, women reported a significant reduction in intrusion and avoidance. Intrusion levels were increased among women who had lost a first-degree relative to breast cancer. Predictors of increased long-term distress were passive and palliative coping styles, excessive breast self-examination, and overestimation of breast cancer risk. On the other hand, coping through fostering reassuring thoughts was predictive for decreased long-term distress. CONCLUSION: On the basis of the identified risk profile, it is possible to identify vulnerable women at an early stage, who then may be offered additional and individually tailored support.