The effectiveness of a training for patients with unexplained physical symptoms: protocol of a cognitive behavioral group training and randomized controlled trial

Abstract: BACKGROUND: In primary care, up to 74% of physical symptoms is classified as unexplained. These symptoms can cause high levels of distress and healthcare utilization. Cognitive behavioral therapy has shown to be effective, but does not seem to be attractive to patients. An exception herein is a therapy based on the consequences model, which distinguishes itself by its labeling of psychosocial distress in terms of consequences rather than as causes of physical symptoms. In secondary care, 81% of the patients accepts this therapy, but in primary care the outcome is poor. We assume that positive outcome can also be reached in primary care, when the consequences model is modified and used bottom-up in an easily accessible group training, in which patients are relieved of being blamed for their symptoms. Our aim is to investigate the (cost-)effectiveness of this training. METHODS AND DESIGN: A randomized controlled trial is designed. One hundred patients are randomized to either the group training or the waiting list. Physicians in general practices and outpatients clinics of general hospitals refer patients. Referral leads to inclusion if patients are between 18 and 65 years old, understand Dutch, have no handicaps impeding participation and the principal DSM-IV-TR classification is undifferentiated somatoform disorder or chronic pain disorder. In contrast to other treatment effect studies, the co-morbidity of a personality disorder does not lead to exclusion. By this, we optimize the comparability between the study population and patients in daily practice enlarging the generalization possibilities. Also in contrast to other effect studies, we chose quality of life (SF-36) instead of physical symptoms as the primary outcome measure. The SF-6D is used to estimate Quality Adjusted Life Years (QALYs). Costs are measured with the Trimbos/iMTA Questionnaire for Costs associated with Psychiatric Illness. Measurements are scheduled at baseline, after the training or waiting list, three and twelve months after the training. The differences between measurements are analyzed according to the intention-to-treat principle. The cost-effectiveness is expressed as costs per QALY, using multiple sensitivity analyses on the basis of a probabilistic model of the trial. DISCUSSION: If we show that our group training is (cost-)effective, more patients could be served, their quality of life could be improved while costs might be reduced. As the training is investigated in a heterogeneous patient group i

Shortening the State-Trait Anxiety Inventory

Abstract Questionnaires that are used in studies with severely ill patients should be as short as possible. Abridged versions of existing inventories are very practical in these instances. The answers of 444 subjects in three samples (cancer patients, medical students, surgical patients) were used to investigate the possibility of constructing short and reliable versions of the scales of the State and Trait Anxiety Inventory. A stepwise regression procedure showed the possibility to reliably predict the total score of the unabridged versions by means of weighted sums of eight items for each scale. Omission of weights did not lead to substantial loss of information. Cronbach's α of the State-scale decreased from 0.93 to about 0.85 for different combinations of items and from 0.91 to about 0.82 for combinations of eight items of the Trait-scale. The relationship between both scales was only slightly modified by the shortening procedure

Child development and quality of parenting in lesbian families: no psychosocial indications for a-priori withholding of infertility treatment. A systematic review

Among fertility centres, much discussion focuses on whether to withhold infertility treatment from special patient groups (lesbians, prospective single parent(s), prospective parent(s) of relatively advanced age, or with severe diseases) because it is assumed that this is in the best interest of the child. The present study aimed to establish whether there is any empirical evidence for this assumption. A literature search was made in PubMed/Medline and PsycINFO to identify studies that had assessed psychological outcomes of children and quality of parenting after infertility treatment. Eight studies met the following inclusion criteria: published in an English-language peer-reviewed journal between 1978 and 2002, and focused on psychosocial child development and quality of parenting after infer

Quality of life and maladjustment associated with hair loss in women with alopecia androgenetica

Quality of life and maladjustment related to hair loss were studied by means of a standardized interview in a group of 58 women with alopecia androgenetica who applied for treatment at the Department of Dermatology. The hair loss was found to have a negative influence on the quality of life on the majority of them. In 88%, hair loss had negative effects on their daily life; in about 75%, the hair problems were manifested in negative self-esteem and about 50% experienced social problems. General psychosocial maladjustment in relation to hair loss was indicated in almost one-third of the women

The development of the DISCO-RC for measuring children's discomfort during research procedures

Background: There is a need for data on children's self-reported discomfort in clinical research, helping ethics committees to make their evaluation of discomfort described in study protocols evidence-based. Since there is no appropriate instrument to measure children's discomfort during medical research procedures, we aimed to develop a generic, short and child-friendly instrument: the DISCO-RC questionnaire (DISCOmfort in Research with Children). Methods: This article describes the six steps of the development of the DISCO-RC. First, we updated a literature search on children's self-reported discomfort in clinical research to get insight in what words are used to measure discomfort (step 1). Subsequently, we interviewed 46 children (6-18years) participating in research to get insight into important forms of discomfort for children (step 2), and asked them about their preferred response option for measuring discomfort (step 3). Next, we consulted nine paediatric research professionals from various backgrounds for input on the content and feasibility of the DISCO-RC (step 4). Based on the previous steps, we developed a draft version of the DISCO-RC, which we discussed with the professionals. The DISCO-RC was then pretested in 25 children to ensure face-validity from the child's perspective and feasibility (step 5). Finally, validity, reliability and internal consistency were tested (step 6). Results: The search-update revealed several words used for measuring discomfort in research (e.g. 'worries', 'unpleasantness'). The interviews gave insight into important forms of discomfort for children in research (e.g. 'pain', 'boredom'). Children preferred a 5-point Likert scale as response option for the DISCO-RC. The experts recommended a short, digital instrument involving different forms of discomfort, and measuring discomfort of individual research procedures. Pretesting of the DISCO-RC resulted in a few layout changes, and feedback from the children confirmed the feasibility of the DISCO-RC. Convergent validity and test-retest reliability were acceptable. Internal consistency based on item-rest correlations and Cronbach's alpha were low, as expected. Conclusions: The DISCO-RC is a generic, practical and psychometrically sound instrument for measuring children's discomfort during research procedures. It contributes to make the evaluation of discomfort in paediatric research evidence-based. Therefore, we recommend including the DISCO-RC as standard component of paediatric research studies

Mens (dood of levend) of dier? Attitudes over en morele implicaties van orgaanverwerving

Dit rapport is het verslag van een verkennende studie naar attitudes met betrekking tot orgaandonatie, en de morele implicaties hiervan. Psychologisch en ethisch onderzoek vullen elkaar in dit rapport aan. Er wordt aandacht geschonken aan twee ontwikkelingen op het gebied van orgaanverwerving: de toename van orgaandonaties bij leven, met name bij donatie van nieren en de verminderde interesse in de ontwikkeling van xenotransplantatie. Het psychologische deel van het rapport valt uiteen in literatuurstudie en eigen empirisch onderzoek. In dit deel wordt zowel de attitude van patiënten als de psychosociale belasting beschreven voor xenotransplantatie en voor nierdonatie bij leven. Patiënten zien nierdonatie bij leven in het algemeen als een wenselijk alternatief voor de wachtlijstsituatie, terwijl men in dit opzicht een stuk terughoudender is ten aanzien van xenotransplantatie. Om te bepalen welke rol van overheid, zorgverleners en onderzoekers gepast is, is het van belang te begrijpen hoe persoonlijke overtuigingen worden gevormd en kunnen veranderen. In het ethische, tweede deel van het rapport wordt dan ook meer aandacht besteed aan de verschillende motivaties voor orgaandonatie. Bij postmortale donatie worden vooral waarden als vrijwilligheid, anonimiteit en altruïsme genoemd. Bij familiedonatie doen begrippen als vanzelfsprekende solidariteit, morele plicht en lotsverbondenheid hun intrede, maar ook begrippen als eigenbelang, afhankelijkheid en wederkerigheid. Onderzocht wordt hoe de verschillende donatievormen zich tot elkaar verhouden, teneinde te bepalen op welke motivaties voor orgaandonatie we als maatschappij een beroep willen doen. Op dit punt wordt expliciet ingegaan op de rol van de overheid. Tevens is er een meer losstaand hoofdstuk gewijd aan commerciële orgaandonatie

Hearing the voices of children: self-reported information on children's experiences during research procedures

__Introduction:__ In paediatric research, there is a tension between what you can ask from a child and what is needed for the development of evidence-based treatments. To find an optimal balance in conducting clinical research and protecting the child, it is necessary to have empirical data on children's experiences. Until now, there are scarce empirical data on the experiences from the perspective of the child. In this manuscript, we describe the protocol of a twophase study measuring children's self-reported experiences during research procedures. __Methods and analysis:__ In the first phase of our study, we aim to interview approximately 40 children (6-18 years) about their self-reported experiences during research procedures. In the second phase, we will develop a questionnaire to measure children's experiences during research procedures in a quantitative way. We will use the interview outcomes for the development of this questionnaire. Next, we will measure the experiences of children during seven research procedures with this questionnaire. A one-month followup is conducted to investigate the emotional impact of the research procedures on the children. Children will be recruited from different research studies in three academic children's hospitals in the Netherlands. __Ethics and dissemination:__ The ethics committee of the VU University medical center evaluated both studies and indicated that there was no risk/discomfort associated, stating that both phases are exempt from getting