Possible alleviation of symptoms and side effects through clinicians' nocebo information and empathy in an experimental video vignette study.

To alleviate anti-cancer treatment burden in advanced breast cancer, patient-clinician communication strategies based on nocebo-effect mechanisms are promising. We assessed distinct/combined effects on psychological outcomes (e.g. anxiety; main outcome) and side-effect expectations of (1) nocebo information about the (non)pharmacological origin of side effects, and (2) clinician-expressed empathy through reassurance of continuing support. Furthermore, we explored whether information and empathy effects on side-effect expectations were mediated by decreased anxiety. In a two-by-two experimental video-vignette design, 160 cancer patients/survivors and healthy women watched one of four videos differing in level of nocebo information (±) and empathy (±). Regression and mediation analysis were used to determine effects of information/empathy and explore anxiety's mediating role. Anxiety was not influenced by empathy or information (Stai-state: p = 0.295; p = 0.390, VAS p = 0.399; p = 0.823). Information improved (specific) side-effect coping expectations (p < 0.01). Empathy improved side-effect intensity expectations (p < 0.01 = specific; p < 0.05 = non-specific/partial) and specific side-effect probability expectations (p < 0.01), and increased satisfaction, trust, and self-efficacy (p < 0.001). No mediating effects were found of anxiety on expectations. Mainly empathy, but also nocebo information improved psychological outcomes and-mainly specific-side-effect expectations. Exploring the power of these communication elements in clinical practice is essential to diminish the anti-cancer treatment burden in advanced breast cancer.

Development of the Leiden Independence Questionnaire for Support Staff: a measure of staff behaviour regarding promoting independence of people with intellectual disabilities.

BACKGROUND: Support staff of adults with intellectual disability (ID) play an important role in promoting independence in home and community settings. However, little is known about the types of behaviours staff should use to promote independence and instruments that assess such behaviour do not yet exist. The aim of this study was therefore to develop and initially validate a reliable questionnaire that measures the degree to which support staff display behaviours that promote independence in people with ID. METHOD: The Leiden Independence Questionnaire for Support Staff (LIQSS) was constructed to measure the extent to which support staff promote independence in people with ID. The LIQSS was completed by 142 staff members working with people with ID. For the psychometric evaluation of the LIQSS, a principal component analysis was performed with an oblique rotation in all items. Next, the principal component analysis was performed with a forced three-component extraction, and three sub-scales were computed. To assess internal consistency, Cronbach's α was calculated for each of the sub-scales. RESULTS: The LIQSS was found to consist of three internally consistent (Cronbach's α was respectively 0.92, 0.79 and 0.76) and meaningful components: (1) communication, agreements and coordination; (2) positive encouragement and tailoring; and (3) supporting independent performance. The final 22 items had factor loadings between 0.44 and 0.91 on their corresponding component and a minimal difference in loading to the other factors of 0.20. CONCLUSIONS: The LIQSS appears to be an instrument with positive face validity and reliability (internal consistency) that assesses the degree to which support staff promote independence in people with ID. To increase the instrument's value for both scientific research and clinical practice, studies should focus on the further validation of the LIQSS.

Laying-up of sterile instruments in the operating theatre: equal or superior protection by using a horizontal unidirectional air flow system.

BACKGROUND: A system for the preparation of sterilized instruments with unidirectional horizontal air flow (UDHF) has several advantages over a unidirectional down flow system (UDDF). The advantages are based on the installation of the system being more flexible and easier to use, no cooling of the air flow being necessary and less air being needed for circulation, resulting in reduced energy use. OBJECTIVES: The objective of this study was to determine whether a system with UDHF performs equal or superior to a system with UDDF in terms of prevention of contamination of the air (the presence of particles and micro-organisms) during the laying-up process. METHODS: The degree of protection (DP) offered by two UDHF system variants and two UDDF system variants was determined for several static set-ups and a dynamic simulation of the process. In addition to determining the level of protection for several categories of particle size, colony-forming units (CFU) were also measured during process simulations. FINDINGS: When maximum protection (no particles present) is considered, the UDHF systems performed significantly better than the UDDF systems for particles ≥2.5µm. When particles were present, there was no significant difference between systems for particles ≥0.3 and ≥0.5µm. However, the performance of the UDHF system was superior to that of the UDDF system (DP) for particles ≥1.0µm representing the bacteria-carrying particles. During the process measurements, no CFU were found with the UDDF system in 64% of the measurements, compared with 90% for the UDHF system (P = 0.012). CONCLUSIONS: The UDHF system offers equal or superior protection to the UDDF system against contamination of the clean area within which the laying up takes place. Despite our finding that the differences did not always reach statistical significance (due to low background concentrations), there is a clear trend, from the small-sized particles (≥1.0µm) up to the largest sizes considered, including bacteria-carrying particles, that demonstrates the superiority of the horizontal flow system. The UDHF system offers a more robust solution than the UDDF system, provided that good work instructions are given and the height of the table and height of the plenum are properly adjusted.

Impact of the physical environment of psychiatric wards on the use of seclusion.

BACKGROUND: The physical environment is presumed to have an effect on aggression and also on the use of seclusion on psychiatric wards. Multicentre studies that include a broad variety of design features found on psychiatric wards and that control for patient, staff and general ward characteristics are scarce. AIMS: To explore the effect of design features on the risk of being secluded, the number of seclusion incidents and the time in seclusion, for patients admitted to locked wards for intensive psychiatric care. METHOD: Data on the building quality and safety of psychiatric as well as forensic wards (n = 199) were combined with data on the frequency and type of coercive measures per admission (n = 23 868 admissions of n = 14 834 patients) on these wards, over a 12-month period. We used non-linear principal components analysis (CATPCA) to reduce the observed design features into a smaller number of uncorrelated principal components. Two-level multilevel (logistic) regression analyses were used to explore the relationship with seclusion. Admission was the first level in the analyses and ward was the second level. RESULTS: Overall, 14 design features had a significant effect on the risk of being secluded during admission. The 'presence of an outdoor space', 'special safety measures' and a large 'number of patients in the building' increased the risk of being secluded. Design features such as more 'total private space per patient', a higher 'level of comfort' and greater 'visibility on the ward', decreased the risk of being secluded. CONCLUSIONS: A number of design features had an effect on the use of seclusion and restraint. The study highlighted the need for a greater focus on the impact of the physical environment on patients, as, along with other interventions, this can reduce the need for seclusion and restraint.

Significant impact of recurrent respiratory tract infections in children with Down syndrome.

OBJECTIVE: Parents and health professionals believe that recurrent respiratory tract infections (RRTI) have a large impact on children with Down syndrome (DS). We studied the relation between parent-reported RRTI and development, behaviour and health-related quality of life (HRQoL) in 8-year-old children with DS. METHOD: During a 3-year period, 325 children with DS were recruited for inclusion in this observational study. Parents were asked to fill in the Child Behavior Checklist and TNO-AZL Children's Quality of Life Parent Form. A psychological assistant administrated the McCarthy Scales of Children's Abilities. The children were divided into a group with presence of RRTI (RRTI (+) ) and a group without RRTI (RRTI (-) ), on the basis of parental report. Linear regression analyses were performed to assess the effect of RRTI, while correcting for the influence of confounders. RESULTS: Compared with RRTI (-) children (n = 176), RRTI (+) children (n = 149, 46%) showed decreased mental and motor development (mean developmental age 3.67 vs. 4.08 years), more behavioural problems and lower scores on most HRQoL scales (P < 0.05). Moreover, school enrolment is less favourable in RRTI (+) children. CONCLUSION: In 8-year-olds with DS, the children with parent-reported RRTI show more delayed development, more behavioural problems and lower HRQoL compared with the children without RRTI. Although this association does not prove a causal relationship, further studies should focus on this, because RRTI are potentially preventable.

Survival of patients with nonseminomatous germ cell cancer: a review of the IGCC classification by Cox regression and recursive partitioning.

The International Germ Cell Consensus (IGCC) classification identifies good, intermediate and poor prognosis groups among patients with metastatic nonseminomatous germ cell tumours (NSGCT). It uses the risk factors primary site, presence of nonpulmonary visceral metastases and tumour markers alpha-fetoprotein (AFP), human chorionic gonadotrophin (HCG) and lactic dehydrogenase (LDH). The IGCC classification is easy to use and remember, but lacks flexibility. We aimed to examine the extent of any loss in discrimination within the IGCC classification in comparison with alternative modelling by formal weighing of the risk factors. We analysed survival of 3048 NSGCT patients with Cox regression and recursive partitioning for alternative classifications. Good, intermediate and poor prognosis groups were based on predicted 5-year survival. Classifications were further refined by subgrouping within the poor prognosis group. Performance was measured primarily by a bootstrap corrected c-statistic to indicate discriminative ability for future patients. The weights of the risk factors in the alternative classifications differed slightly from the implicit weights in the IGCC classification. Discriminative ability, however, did not increase clearly (IGCC classification, c=0.732; Cox classification, c=0.730; Recursive partitioning classification, c=0.709). Three subgroups could be identified within the poor prognosis groups, resulting in classifications with five prognostic groups and slightly better discriminative ability (c=0.740). In conclusion, the IGCC classification in three prognostic groups is largely supported by Cox regression and recursive partitioning. Cox regression was the most promising tool to define a more refined classification. British Journal of Cancer (2004) 90, 1176-1183. doi:10.1038/sj.bjc.6601665 www.bjcancer.com Published online 24 February 2004

Condom use self-efficacy: effect on intended and actual condom use in adolescents.

PURPOSE: To investigate aspects of adolescents' condom use self-efficacy that affect their intended and actual condom use. METHODS: Four hundred twenty-four male and female sexually experienced and inexperienced adolescents with a mean age of 17.0 years filled out a questionnaire concerning condom use self-efficacy and intended and actual condom use. Specific condom use self-efficacy scales were constructed from 37 items on the basis of a principal component analysis. The effect of self-efficacy, both as a global measure and in terms of specific scales, on condom use intention and consistency was assessed using multiple hierarchic regression analyses. RESULTS: Six specific self-efficacy scales were constructed: Technical Skills, Image Confidence, Emotion Control, Purchase, Assertiveness, and Sexual Control. In sexually inexperienced adolescents, global self-efficacy explained 48%, the six self-efficacy scales 30%, and both together 51% of the variance in intention, after statistical control for gender, age, and education level. In the sexually experienced sample, this was 40%, 50%, and 57% for intention, and 23%, 29%, and 33% for consistency of condom use. Significant predictors of intention in the final model were gender, age, global self-efficacy and purchasing skills in the inexperienced sample, and global self-efficacy, emotion control, assertiveness, image confidence, and sexual control in the experienced sample, whereas gender, age, global self-efficacy, emotion control, assertiveness, and purchase predicted consistency of condom use in the experienced sample. CONCLUSIONS: Condom use self-efficacy is a multidimensional construct. Intended and actual condom use in adolescents are best predicted by self-efficacy measures that include both global and relevant specific aspects of condom use.

Prediction in medicine by integrating regression trees into regression analysis with optimal scaling.

OBJECTIVES: A new data-analysis strategy is proposed to solve the problems of selecting interaction terms in linear regression on the one hand, and of statistically testing the significance of regression trees on the other hand. METHODS: The proposed strategy combines two data mining techniques: regression trees and regression analysis with optimal scaling (CATREG). The method traces small regression trees using the bootstrap and integrates the results as interaction variables (called "trunk variables") into CATREG. RESULTS: An application to data from cardiac patients shows a relative increase of 19% variance accounted for (16% cross-validated variance), by the CATREG model including the trunk variables compared to the model excluding these variables. CONCLUSIONS: This study indicates that trunk variables can be useful to model interaction effects in prediction problems.

Coping with coronary heart disease: a longitudinal study.

This longitudinal study evaluated the effects of two types of coping strategies, approach and avoidance, on anxiety, depression, and well-being in patients with coronary heart disease. Measurements were made at three timepoints: 1 month, 3 months, and 12 months after the cardiac event. Both cross-sectional and longitudinal relations were explored. At all three measurement points significant negative cross-sectional relations were found between approach and well-being, and significant positive cross-sectional relations were found between approach, on the one hand, and anxiety and depression, on the other. At the first measurement point, avoidance showed a positive association with well-being, and a negative association with anxiety. Longitudinal analyses, however, revealed a negative relationship between approach at the first measurement points and anxiety and depression at later measurement points. Likewise, there was a positive association between approach at the first two measurement points and well-being at later measurement points. The results of this study demonstrate the importance of facing and working through the trauma of the coronary event. Although unfavorable in the short term, working through the trauma can attenuate long-term emotional distress. These results suggest that assessment of the psychological consequences of coronary heart disease and development of interventions should not be based only on cross-sectional data, but should take into account longitudinal relations between coping and psychosocial outcome measures.

A meta-analysis of psychoeduational programs for coronary heart disease patients.

In a meta-analysis of 37 studies, the effects of psychoeducational (health education and stress management) programs for coronary heart disease patients were examined. The results suggest that these programs yielded a 34% reduction in cardiac mortality; a 29% reduction in recurrence of myocardial infarction (MI); and significant (p < .025) positive effects on blood pressure, cholesterol, body weight, smoking behavior, physical exercise, and eating habits. No effects of psychoeducational programs were found in regard to coronary bypass surgery, anxiety, or depression. The results also suggest that cardiac rehabilitation programs that were successful on proximal targets (systolic blood pressure, smoking behavior, physical exercise, emotional distress) were more effective on distal targets (cardiac mortality and MI recurrences) than programs without success on proximal targets.

Measuring transitions through stages of exercise: application of latent transition analysis.

In this longitudinal study of 504 nursing staff members from seven Dutch nursing homes, which transitions in exercise behaviour had occurred over a 12-mo. period were investigated. For this purpose, latent transition analyses were employed. Latent transition analysis is an extension of Markov chain modelling and of Latent class analysis and has been especially developed to study dynamic latent variables. The data supported the notion that natural change in exercise occurs through various stages and that these are sequential in nature. Latent transition analysis was an effective method for the comparison of various models describing possible transitions over time and for estimation of the likelihood of the occurrence of such transitions.

Gender differences in psychosocial profile at entry into cardiac rehabilitation.

PURPOSE: To find out in a sample of coronary patients at entry into a cardiac rehabilitation program, whether women report a lower level of physical functioning and a higher degree of psychosocial impairment than men. METHODS: One hundred and nine male and 122 female patients matched for age with a diagnosis of myocardial infarction, coronary artery bypass grafting, or coronary angioplasty were assessed at entry into a multidisciplinary outpatient rehabilitation program. Information was retrieved from hospital records, a semistructured interview, and several psychological questionnaires. Variables of physical functioning included perceived exercise tolerance, functional complaints, psychosomatic complaints, and sleeping disturbances. Variables of psychosocial impairment included anxiety, depression, vital exhaustion, well-being, feelings of being disabled, displeasure, and social inhibition. RESULTS: At program entry, there were no significant differences in age, coronary risk factors, coronary incident, or medication between genders. However, women reported significantly lower perceived exercise tolerance and significantly more functional and psychosomatic complaints. Moreover, women were significantly more anxious and scored significantly higher on social inhibition and vital exhaustion than men. CONCLUSIONS: At entry into rehabilitation, women in this sample report a higher degree of psychosocial impairment and a lower level of physical functioning than men. Women's significantly higher scores on social inhibition and vital exhaustion might partly explain their reported higher drop-out and lower adherence rates in cardiac rehabilitation.

Continuation of antiarrhythmic drugs, or arrhythmia surgery after multiple drug failures. A randomized trial in the treatment of postinfarction ventricular tachycardia.

BACKGROUND: In patients with postinfarction sustained ventricular tachycardia showing one or more antiarrhythmic drug failures, the question is how long to proceed with new drug trials before deciding to perform map-guided arrhythmia surgery. Although the techniques of this surgery developed rapidly in the early 1980s, this therapy may be offset by damage to residual left ventricular function. However, surgery has been shown to be very effective in selected groups of patients. METHODS: A randomized study was carried out in patients with postinfarction ventricular tachycardia and eligible for arrhythmia surgery based on residual left ventricular function. Therapy failure was defined by the occurrence of the following events: spontaneous recurrence of ventricular tachycardia or ventricular fibrillation, sudden cardiac death, inducibility of sustained ventricular tachycardia or ventricular fibrillation with programmed stimulation of the heart, symptomatic non-sustained ventricular tachycardia requiring therapy or side-effects of antiarrhythmic drugs requiring withdrawal. In the drug limb, failure of the first antiarrhythmic drug was accepted but failure of a second and different drug was regarded as true therapy failure. RESULTS: After randomization, antiarrhythmic drug therapy was administered in 33 patients, and 30 patients underwent surgery. Neither group differed in baseline characteristics, and the mean number of drug failures before randomization was 2.7. The Kaplan-Meier therapeutic failure of antiarrhythmic drugs was 39 +/- 11%, 42 +/- 11% and 51 +/- 18% at 0.5-, 1- and 4-year follow-up, respectively, whereas the therapeutic failure of cardiac surgery was 37 +/- 11%, 37 +/- 11% and 50 +/- 20% at 0.5, 1 and 4 years, respectively, showing no statistical difference. The 1- and 4-year Kaplan-Meier survival of the antiarrhythmic drug-treated group was 91 +/- 6% and 78 +/- 15%, respectively, and of the surgical group 92 +/- 6% and 59 +/- 20%, respectively, and did not differ between either group. However, the relative risk for total cardiac death was higher in the surgical limb than in the drug limb (relative risk 2.2, CI 0.68-7.48). CONCLUSION: This study demonstrated no difference between the therapeutic result of continuation of two different antiarrhythmic drugs and that of arrhythmia surgery. Despite the small number of patients studied, it is recommended that drug therapy should continue as long as this regimen is tolerated by the patient. When true drug refractoriness or side-effects of drugs arise, arrhythmia surgery offers a valuable alternative. However, when additional reasons for cardiac surgery exist, arrhythmia surgery should be undertaken earlier and may become the first choice of treatment of postinfarction ventricular tachycardia.