The size of the treatment effect: do patients and proxies agree?

BACKGROUND: This study examined whether MS patients and proxy respondents agreed on change in disease impact, which was induced by treatment. This may be of interest in situations when patients suffer from limitations that interfere with reliable self-assessment, such as cognitive impairment. METHODS: MS patients and proxies completed the Multiple Sclerosis Impact Scale (MSIS-29) before and after intravenous steroid treatment. Analyses focused on patient-proxy agreement between MSIS-29 change scores. Transition ratings were used to measure the patient's judgement of change and whether this change was reflected in the MSIS-29 change of patients and proxies. Receiver operating characteristic (ROC) analyses were also performed to examine the diagnostic properties of the MSIS-29 when completed by patients and proxies. RESULTS: 42 patients and proxy respondents completed the MSIS-29 at baseline and follow-up. Patient-proxy differences between change scores on the physical and psychological MSIS-29 subscale were quite small, although large variability was found. The direction of mean change was in concordance with the transition ratings of the patients. Results of the ROC analyses of the MSIS-29 were similar when completed by patients (physical scale: AUC = 0.79, 95% CI: 0.65-0.93 and 0.66, 95% CI: 0.48-0.84 for the psychological scale) and proxies (physical scale: 0.80, 95% CI: 0.72-0.96 and 0.71, 95% CI: 0.56-0.87 for the psychological scale) CONCLUSION: Although the results need to be further explored in larger samples, these results do point towards possible use of proxy respondents to assess patient perceived treatment change at the group level.

Longitudinal proxy measurements in multiple sclerosis: patient-proxy agreement on the impact of MS on daily life over a period of two years.

BACKGROUND: The use of self-report measurements in clinical settings is increasing. However, in patients with limitations that interfere with reliable self-assessment such as cognitive impairment or mood disturbances, as may be the case in multiple sclerosis (MS), data collection might be problematic. In these situations, information obtained from proxy respondents (e.g. partners) may replace self-ratings. The aim of this study was to examine the value of proxy ratings at separate points in time and to assess patient-proxy agreement on possible changes in disease impact of MS. METHODS: Fifty-six MS patients and their partners completed the Multiple Sclerosis Impact Scale (MSIS-29) at baseline and follow-up, two years later. Patient-proxy agreement was assessed at both time points by calculating intraclass correlation coefficients (ICCs), exact and global agreement and the mean directional differences between groups. Agreement of change over time was assessed by calculating ICCs between change scores. In parallel, global ratings of both patients and proxy respondents of the extent to which the patient had improved or deteriorated over the past two years were collected to validate possible changes on the MSIS-29. RESULTS: At both time points, agreement on the physical scale was higher than agreement on the psychological scale (ICCs at baseline were 0.81 for the physical scale and 0.72 for the psychological scale; at follow-up, the ICC values were 0.86 and 0.65 respectively). At follow-up, statistically significant mean differences between patients and proxies were noted for the physical scale (-4.8 +/- 12.7, p = 0.006) and the psychological scale (-8.9 +/- 18.8, p = 0.001). Agreement between change scores on the MSIS-29 was fair (ICC < 0.60). Our analyses suggest that the validity of measuring changes over time might be better for proxy respondents compared to patients. CONCLUSION: Proxy respondents could act as a reliable source of information in cross-sectional studies. Moreover, results suggested that agreement on change over time might be better for proxy respondents compared to patients. Although this remarkable finding should be interpreted cautiously because of several limitations of the study, it does plead for further investigation of this important topic.

The course of neurocognitive functioning in high-grade glioma patients.

We evaluated the course of neurocognitive functioning in newly diagnosed high-grade glioma patients and specifically the effect of tumor recurrence. Following baseline assessment (after surgery and before radiotherapy), neurocognitive functioning was evaluated at 8 and 16 months. Neurocognitive summary measures were calculated to detect possible deficits in the domains of (1) information processing, (2) psychomotor function, (3) attention, (4) verbal memory, (5) working memory, and (6) executive functioning. Repeated-measures analyses of covariance were used to evaluate changes over time. Thirty-six patients were tested at baseline only. Follow-up data were obtained for 32 patients: 14 had a follow-up at 8 months, and 18 had an additional follow-up at 16 months. Between baseline and eight months, patients deteriorated in information-processing capacity, psychomotor speed, and attentional functioning. Further deterioration was observed between 8 and 16 months. Of 32 patients, 15 suffered from tumor recurrence before the eight-month follow-up. Compared with recurrence-free patients, not only did patients with recurrence have lower information-processing capacity, psychomotor speed, and executive functioning, but they also exhibited a more pronounced deterioration between baseline and eight-month follow-up. This difference could be attributed to the use of antiepileptic drugs in the patient group with recurrence. This study showed a marked decline in neurocognitive functioning in HGG patients in the course of their disease. Patients with tumor progression performed worse on neurocognitive tests than did patients without progression, which could be attributed to the use of antiepileptic drugs. The possibility of deleterious effects is important to consider when prescribing antiepileptic drug treatment.

Dimensionality of the posttraumatic stress response among police officers and fire fighters: an evaluation of two self-report scales.

Confirmatory factor analyses were done to assess the dimensionality of the stress response in a sample of police officers and fire fighters (n = 1,168) involved in the 1992 air disaster in Amsterdam. The confirmatory factor analyses were applied to the responses on two psychometrically different instruments, i.e., the Self-Rating Inventory for Posttraumatic Stress Disorder (SRIP) and the Impact of Event Scale (IES). The previously found distinction between (active) avoidance and numbing in samples highly affected by posttraumatic stress disorder appears to be applicable to the stress response of a less affected sample. For the SRIP, a five-factor structure (i.e., intrusion, avoidance, hyperarousal, emotional numbing and sleep disturbance) appeared to fit slightly better than the four-factor structures from previous findings. For the IES, our results replicated findings of a four-dimensional structure (i.e., intrusion, avoidance, numbing and sleep disturbance) underlying the posttraumatic stress response. The factors of the best-fitting structure of both instruments proved reliable. Due to the psychometric properties of the two instruments, the relationship between similar factors in both instruments was only low to moderate. Compared with the IES, factors of the SRIP were, however, less discriminative from other symptoms of psychopathology. Replication in different traumatized or community samples is recommended.

Cosmic transcendence and framework of meaning in life: patterns among older adults in the Netherlands.

OBJECTIVES: Gerotranscendence has been conceptualized as a potential development accompanying normal aging. Gerotranscendence is defined as a shift in metaperspective from a materialistic and pragmatic world view to a more cosmic and transcendent one. In the past decade, population-based studies have tested Tornstam's Gerotranscendence Scale. Its Cosmic Transcendence subscale, in particular, emerged as consistent. The aim of the present study was to examine (a) how cosmic transcendence relates to having a framework of meaning in life and (b) whether religiousness and demographic characteristics influence possible relationships. METHODS: Participants were 928 older Dutch adults who responded to a questionnaire that included the Cosmic Transcendence scale, aspects of religiousness, and the Framework of Meaning in Life subscale of the Life Regard Index. RESULTS: A substantial, positive association between cosmic transcendence and framework of meaning in life was observed. This association was much more pronounced among participants who were less involved in religion, who were women, who were age 75 or older, or who were widowed. DISCUSSION: The current study indicates that the personal relevance of cosmic transcendence depends on cultural factors such as secularization. Furthermore, cosmic transcendence seems to unfold as an important domain in the life view of women, the older old, and the widowed.

Cognitive behavioural group training (CBGT) for patients with type 1 diabetes in persistent poor glycaemic control: who do we reach?

Approximately a quarter of adults with type 1 diabetes do not succeed in achieving satisfactory glycaemic control, partly due to problems with the demanding self-management regimen. To improve glycaemic control, interventions with a cognitive behavioural approach, aimed at modifying dysfunctional beliefs, reducing negative emotions and enhancing self-care practices are a potentially successful tool. Little is known about the reach of such an approach. This article describes characteristics of participants in a randomized, controlled trial of cognitive behavioural group training for patients with type 1 diabetes in poor glycaemic control. Results show that outpatients from seven hospitals in the area of Amsterdam, selected on long-standing high HbA1c and volunteering to participate, report high levels of psychological distress and depressive symptoms. Furthermore, self-care behaviours were perceived as important, but burdensome. Diabetes-specific self-efficacy was relatively low. It is concluded that this selected group of adults with type 1 diabetes would potentially benefit from a cognitive-behavioural intervention in order to reduce negative emotions, enhance diabetes self-efficacy, self-care behaviour and glycaemic outcomes.

Epidemiological study air disaster in Amsterdam (ESADA): study design.

BACKGROUND: In 1992, a cargo aircraft crashed into apartment buildings in Amsterdam, killing 43 victims and destroying 266 apartments. In the aftermath there were speculations about the cause of the crash, potential exposures to hazardous materials due to the disaster and the health consequences. Starting in 2000, the Epidemiological Study Air Disaster in Amsterdam (ESADA) aimed to assess the long-term health effects of occupational exposure to this disaster on professional assistance workers. METHODS/DESIGN: Epidemiological study among all the exposed professional fire-fighters and police officers who performed disaster-related task(s), and hangar workers who sorted the wreckage of the aircraft, as well as reference groups of their non-exposed colleagues who did not perform any disaster-related tasks. The study took place, on average, 8.5 years after the disaster. Questionnaires were used to assess details on occupational exposure to the disaster. Health measures comprised laboratory assessments in urine, blood and saliva, as well as self-reported current health measures, including health-related quality of life, and various physical and psychological symptoms. DISCUSSION: In this paper we describe and discuss the design of the ESADA. The ESADA will provide additional scientific knowledge on the long-term health effects of technological disasters on professional workers.

Secondary traumatization in partners and parents of Dutch peacekeeping soldiers.

This study examines secondary traumatization among 708 partners and 332 parents of Dutch peacekeepers (i.e., personnel who participated in military actions implemented by international organizations such as the United Nations). Partners or parents of peacekeepers with 4 levels of posttraumatic stress symptoms were compared on posttraumatic stress, health problems, the quality of the marital relationship, and social support. In comparison with partners of peacekeepers without posttraumatic stress disorder (PTSD) symptoms, partners of peacekeepers with PTSD symptoms reported more sleeping and somatic problems, reported more negative social support, and judged the marital relationship as less favorable. No significant differences were found for parents. Thus, peacekeepers' stress reactions were related to various problems of their partners. A systemic approach to the treatment of persons with PTSD appears appropriate.

The confidence in diabetes self-care scale: psychometric properties of a new measure of diabetes-specific self-efficacy in Dutch and US patients with type 1 diabetes.

OBJECTIVE: To examine psychometric properties of the Confidence in Diabetes Self-Care (CIDS) scale, a newly developed instrument assessing diabetes-specific self-efficacy in Dutch and U.S. patients with type 1 diabetes. RESEARCH DESIGN AND METHODS: Reliability and validity of the CIDS scale were evaluated in Dutch (n = 151) and U.S. (n = 190) outpatients with type 1 diabetes. In addition to the CIDS scale, assessment included HbA(1c), emotional distress, fear of hypoglycemia, self-esteem, anxiety, depression, and self-care behavior. The Dutch sample completed additional measures on perceived burden and importance of self-care. Test-retest reliability was established in a second Dutch sample (n = 62). RESULTS: Internal consistency (Cronbach's alpha = 0.86 for Dutch patients and 0.90 U.S. patients) and test-retest reliability (Spearman's r = 0.85, P < 0.0001) of the CIDS scale were high. Exploratory factor analysis showed one strong general factor. Spearman's correlations between the CIDS scale and other measures were moderate and in the expected directions, and high HbA(1c) levels were associated with low CIDS scores in the U.S. sample only. Low CIDS scores were positively associated with self-care but not with glycemic control in the original samples. CIDS scores in the U.S. and Dutch samples did not show any statistically significant differences. U.S. men had higher CIDS scores than U.S. women. CONCLUSIONS: The CIDS scale is a reliable and valid measure of diabetes-specific self-efficacy for use in patients with type 1 diabetes. High psychometric similarity allows for cross-cultural comparisons.

Utility of the impact of event scale in screening for posttraumatic stress disorder.

This study assesses the optimal cut-off point for the Impact of Event Scale and compares its screening properties with those of the Self-rating Inventory for Posttraumatic Stress Disorder among war-related trauma victims. 74 patients with war-related trauma were administered the Impact of Event Scale and the Self-rating Inventory for Posttraumatic Stress Disorder, followed 1 wk. later by the Clinician-administered PTSD Scale. Receiver operating characteristic analysis indicated for the Impact of Event Scale a sensitivity of .77 and a specificity of .51 at a cut-off value of 36. For the Self-rating Inventory for Posttraumatic Stress Disorder a sensitivity of .86 and a specificity of .69 were found at a cut-off value of 52. The authors conclude that careful use of the Impact of Event Scale as a screening measure for Posttraumatic Stress Disorder is warranted.

Cognition and health-related quality of life in a well-defined subgroup of patients with partial epilepsy.

To investigate the extent and nature of the objective and subjective cognitive deficits and health-related quality of life (HRQOL) in adult outpatients with relatively well-controlled partial epilepsy without symptomatic aetiology, who were on carbamazepine (CBZ) monotherapy. Furthermore, we studied the influence of the epilepsy history and medication on various cognitive functions and the HRQOL. 56 outpatients (29 male, 27 female, mean age 41.3 years) with partial epilepsy were compared with 56 age-, gender-, and education-matched healthy controls. Patients were tested on attention, memory, speed of information processing, and executive functioning. Questionnaires aimed at measuring self-perceived cognitive functioning (CFQ) and HRQOL (SF-36) were administered. Mann Whitney-U tests were used to compare the two groups. Linear regression analysis was performed to identify the epilepsy and medication-related factors that are associated with cognitive functioning and HRQOL. Patients scored lower on measures of attention (P = 0.03), learning (P = 0.02) and speed of information processing (P = 0.00). Mental aspects of HRQOL such as fatigue were lower (P = 0.00), whereas physical functioning was unaffected. These patients also expressed reductions in mental functioning as indicated by a low self-perceived cognitive functioning (P = 0.01). Age at onset, duration of epilepsy, seizure type, seizure frequency, localisation, years on CBZ, and CBZ dosage were not related to cognitive functioning or HRQOL. Patients with partial epilepsy, even when able to maintain regular jobs, have impaired cognition and HRQOL that cannot be attributed to their epilepsy history or CBZ dosage or years of CBZ intake. Therefore, physicians should be more aware of their cognition and HRQOL, in addition to the antiepileptic drug regime.

Secondary traumatization in Dutch couples of World War II survivors.

This study examined whether signs of secondary traumatic stress were present in a community sample of couples who experienced World War II. The authors hypothesized that symptoms of posttraumatic stress disorder (PTSD) in either spouse may be predicted not only by his or her own war experiences but also by the war experiences and posttraumatic symptoms of the partner. Approximately 50 years after the end of World War II, 444 couples from a community sample of elderly Dutch citizens answered a questionnaire. A multilevel regression analysis was performed with symptoms of PTSD as the dependent variable. The most important predictors of PTSD symptoms were the number of war events reported by the participant and the current level of PTSD symptoms of his or her spouse. The results lend empirical support to the notion that posttraumatic stress reactions of both members of a couple are not independent from each other. Several explanations of the findings are discussed.

The effectiveness of psychological interventions for patients with relatively well-controlled epilepsy.

Previous reviews about psychological interventions focused on refractory epilepsy patients and were inconclusive; this review investigates what the contribution of the psychologist can be for the large group of patients with relatively well-controlled epilepsy. This review was restricted to the literature reporting on adult patients with relatively well-controlled epilepsy. A literature search on the effect of psychological interventions was conducted using Medline and PsychInfo, including those studies published through March 2002. Applying strict inclusion criteria, a total of seven studies were identified. Four studies incorporated a waiting-list control group. Of these, one study addressing cognitive rehabilitation reported positive results on psychological outcome and one intervention based on comprehensive care led to seizure reduction, whereas all other studies were plagued too much by methodological inadequacies to allow firm conclusions to be drawn. Recommendations for future intervention studies, such as standardized interventions, controlling for positive attention, outcome measures without overlap with the intervention, and a follow-up measurement, are given. It is concluded that a concerted effort to assemble larger patient groups in randomized-controlled studies is a prerequisite to acquiring well-founded knowledge about psychological interventions in patients with relatively well-controlled epilepsy.

Cognition and health-related quality of life in chronic well-controlled patients with partial epilepsy on carbamazepine monotherapy.

As a group, patients with epilepsy have reduced neuropsychological functioning and health-related quality of life (HRQOL), but the status of these factors is uncertain in seizure-free patients with seizure onset in adulthood on monotherapy. Nevertheless, some of these patients report neuropsychological problems. We hypothesized that subtle impairments in neuropsychological functioning and HRQOL may be underdiagnosed and related to these problems. Sixteen patients with localization-related epilepsy on monotherapy carbamazepine were compared with 16 age-, gender-, and education-matched healthy controls by means of a standardized neuropsychological screening battery, questionnaires about HRQOL (Short-Form Health Survey, SF-36), self-perceived neuropsychological functioning (Cognitive Failure Questionnaire), and mood (Profile of Mood States). No objective impairments in selective attention, memory, and executive functioning were found. However, a lower speed of information processing affecting everyday life functioning was found. Lower levels of self-perceived neuropsychological functioning were reported, whereas HRQOL was unimpaired relative to healthy controls. Physicians should not be reassured when patients receive adequate medication that prevents seizures; careful follow-up of speed of information processing and self-perceived neuropsychological functioning is needed.

Health and health care utilisation among asylum seekers and refugees in the Netherlands: design of a study.

BACKGROUND: This article discusses the design of a study on the prevalence of health problems (both physical and mental) and the utilisation of health care services among asylum seekers and refugees in the Netherlands, including factors that may be related to their health and their utilisation of these services. METHODS/DESIGN: The study will include random samples of adult asylum seekers and refugees from Afghanistan, Iran and Somali (total planned sample of 600), as these are among the largest groups within the reception centres and municipalities in the Netherlands. The questionnaire that will be used will include questions on physical health (chronic and acute diseases and somatization), mental health (Hopkins Symptoms Checklist-25 and Harvard Trauma Questionnaire), utilisation of health care services, pre- and post-migratory traumatic experiences, life-style, acculturation, social support and socio-demographic background. The questionnaire has gone through a translation process (translation and back-translation, several checks and a pilot-study) and cross-cultural adaptation. Respondents will be interviewed by bilingual and bicultural interviewers who will be specifically trained for this purpose. This article discusses the selection of the study population, the chosen outcome measures, the translation and cross-cultural adaptation of the measurement instrument, the training of the interviewers and the practical execution of the study. The information provided may be useful for other researchers in this relatively new field of epidemiological research among various groups of asylum seekers and refugees.

Development of a cognitive behavioral group intervention programme for patients with multiple sclerosis: an exploratory study.

A substantial group of patients with multiple sclerosis (MS) has difficulty coping with their disease. Cognitive behavioral group interventions may help these patients cope more effectively with MS. We developed an 8-session group intervention programme for patients recently diagnosed with MS to help them cope more effectively with MS and to overcome negative thoughts and beliefs about the disease to improve health-related quality of life. We tested the feasibility of the group intervention programme and health-related quality of life in a sample of 11 patients recently diagnosed with MS [mean age: 38 (+/-7.9) yr.; 8 women and 3 men]. All patients were recruited through direct referral by their neurologist or by an MS nurse specialist. The programme was conducted in two small groups of 7 patients each, and each group was led by two psychologists. Cognitive behavioral therapy was an important ingredient in each group session as well as sharing of personal experiences and discussing homework assignments. Each session was formatted the same way but addressed a different MS-specific theme, for example, 'coping with physical impairments' or 'communication with medical staff'. Participants experienced a significant improvement in the health-related quality of life domains of psychological status and vitality, as measured by subscales of Disability and Impact Profile and the Short Form-36 Health Survey. Although further studies are warranted, it appears that a short group intervention programme based on cognitive behavioral techniques for patients with MS might have a positive influence on health-related quality of life.

Associations of cortisol with posttraumatic stress symptoms and negative life events: a study of police officers and firefighters.

Given the inconsistent associations of cortisol with posttraumatic stress disorder (PTSD), analysis of basal functioning of the hypothalamic-pituitary-adrenal (HPA) axis in subjects frequently exposed to trauma and critical incidents with a range of PTSD symptomatology, may be valuable. In an epidemiological sample of 1880 police officers and firefighters, associations of salivary cortisol with PTSD, negative life events (NLE) and exposure to a major air disaster more than 8 years earlier, was explored. Probable PTSD was unrelated to cortisol level while past (>8 years earlier) and more recently experienced NLE were associated with lower cortisol levels even after adjustment for confounders. Disaster exposure interacted significantly with PTSD symptoms on cortisol level. In the disaster-exposed subgroup, PTSD symptomclusters of intrusion and hyperarousal (in particular sleep disturbances), were associated with lower and higher cortisol levels, respectively. A final model using backward elimination strategy, retained time of saliva sampling, smoking, gender, and NLE>8 years earlier in the total sample, and additionally symptomclusters of intrusion and hyperarousal in the disaster-exposed subgroup. The final model explained 10% of the variance in cortisol. The findings are discussed in relation to literature on posttraumatic stress and basal functioning of the HPA-axis.

Personality factors and breast cancer risk: a 13-year follow-up.

Consistent scientific evidence on the possible relationship between psychologic variables and breast cancer development is lacking. In 1996, our group first reported on the present prospective, longitudinal study. We found a weak association between a high score on the antiemotionality scale (indicating an absence of emotional behavior or a lack of trust in one's own feelings) and the development of breast cancer. No associations were found between any of the other 10 studied personality traits and breast cancer development. However, the study had a relatively short follow-up and did not investigate interaction effects between various personality traits. Therefore, the current follow-up study was conducted with the same cohort, which included the 9705 women who attended a biennial population surveillance program for breast cancer and completed a self-report personality questionnaire between January 1, 1989, and December 31, 1990. Women who developed breast cancer during the period from May 17, 1995, through January 1, 2003, formed the case group (n = 217) and were compared with age-matched women without breast cancer who formed the control group (n = 868) with regard to personality traits and medical risk factors for breast cancer. None of the personality factors were statistically significantly associated with an increased risk of breast cancer, with or without adjusting for the medical risk factors. Also, the occurrence of a combination of various personality traits (eg, a so-called cancer-prone personality) was not related to breast cancer development.

Psychological distress of rescue workers eight and one-half years after professional involvement in the Amsterdam air disaster.

This study examined specific and general psychological distress 8.5 years following the 1992 cargo aircraft crash in Amsterdam. Participants included 334 occupationally exposed fire fighters and 834 occupationally exposed police officers compared with reference groups of 194 fire fighters and 634 police officers who were exposed to duty-related stressors other than the disaster. On the standardized instruments of psychological distress, exposed fire fighters reported more somatic complaints and fatigue, while exposed police officers reported higher psychological distress on all aspects. The degree and type of exposure at the disaster site and other background factors were associated with several outcomes of psychological distress levels of exposed rescue workers. The disasters' aftermath of rumors about potential health consequences due to toxic exposure likely contributed to the long-lasting psychological distress of some of the rescue workers as well.

Posttraumatic stress in aging World War II survivors after a fireworks disaster: a controlled prospective study.

Little is known about the effects of cumulative trauma and whether traumatized individuals are more vulnerable. In 2000, a fireworks disaster created the possibility to examine this issue among World War II survivors who were part of an ongoing longitudinal study. Between 1998 and 2000 posttraumatic stress increased in disaster exposed respondents as opposed to the control group. War-related reexperiencing and avoidance also increased. The strongest increase occurred in disaster-exposed respondents who had low levels of wartime stress and a slight decrease occurred in those who had high wartime exposure. This unique controlled observation suggests that disasters do increase the levels of posttraumatic stress, and that reactivation of previous traumatic events generally occurs. However, the vulnerability hypothesis was not supported.