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

Avoiding or reversing Hartmann's procedure provides improved quality of life after perforated diverticulitis

INTRODUCTION: The existing literature regarding acute perforated diverticulitis only reports about short-term outcome; long-term following outcomes have not been assessed before. The aim of this study was to assess long-term quality of life (QOL) after emergency surgery for perforated diverticulitis. PATIENTS AND METHODS: Validated QOL questionnaires (EQ-VAS, EQ-5D index, QLQ-C30, and QLQ-CR38) were sent to all eligible patients who had undergone emergency surgery for perforated diverticulitis in five teaching hospitals between 1990 and 2005. Differences were compared between patients that had undergone Hartmann's procedure (HP) or resection with primary anastomosis (PA) and also compared to a sex- and age-matched sample of healthy subjects. RESULTS: Of a total of 340 patients, only 150 patients (44%) were found still alive in July 2007 (median follow-up 71 months). The response rate was 87%. In patients with PA, QOL was similar to the general population, whereas QOL after HP was significantly lower. The presence of a stoma was found to be an independent factor related to worse QOL. The deterioration in QOL was mainly due to problems in physical function and body image. CONCLUSIONS: Survivors after perforated diverticulitis had a worse QOL than the general population, which was mainly due to the presence of an end colostomy. QOL may improve if these stomas are reversed or not be performed in the first place

Living Kidney Donation: Psychological and Ethical Aspects

DOELSTELLING Nierdonatie bij leven levert medisch en maatschappelijk gezien veel voordelen op, maar toch willen of kunnen niet alle nierpatiënten op de wachtlijst en/of hun naasten zich opgeven voor het nierdonatie bij leven programma. De doelstelling van het project ‘Nierdonatie bij leven: psychologische en ethische aspecten’ is het verkrijgen van meer inzicht in de kennis en acceptatie van nierdonatie bij leven. Het gaat hierbij om kennis en acceptatie onder proefpersonen die daadwerkelijk in aanmerking komen voor nierdonatie/ transplantatie bij leven, dat wil zeggen (1) patiënten met eindfase nierfalen op de wachtlijst voor een niertransplantatie en (2) de mensen uit hun omgeving; de potentiële donoren. Het benaderen van deze groepen is de strategie om uit te vinden of, en onder welke voorwaarden, uitbreiding van het nierdonatie bij leven programma praktisch haalbaar en ethisch verdedigbaar is. VRAAGSTELLINGEN Het project omvat twee vraagstellingen. De eerste vraagstelling is: wat zijn de psychologische barrières voor nierdonatie bij leven voor patiënten op de wachtlijst, en de mensen uit hun omgeving? De tweede vraagstelling luidt: wat zijn de morele argumenten om de patiënt en de mensen uit de omgeving van de patiënt (de potentiële donoren) al dan niet actief te benaderen over nierdonatie bij leven? In andere woorden; in hoeverre zijn interventies ethisch verdedigbaar? OPZET PATIËNTEN EN (POTENTIËLE) DONOREN Wij hebben allereerst de groep patiënten die op de wachtlijst voor niertransplantatie staat benaderd (regio Erasmus MC). Aan de patiënt vragen wij toestemming om ook de potentiële donoren uit zijn of haar omgeving te benaderen. Indien beiden hiermee instemmen, vindt het interview met deze potentiële donor plaats. Voor deze studie hebben we tevens een controlegroep benaderd. In de controlegroep zitten patiënten en donoren die nog geen familietransplantatie hebben ondergaan, maar die wel al hebben besloten door te gaan met de donatie bij leven procedure en dit met hun artsen hebben overlegd. INTERVIEW Alle deelnemers aan ons onderzoek zijn geïnterviewd middels een semi-gestructureerd interview. Voorafgaand onderzoek heeft aangetoond dat een aantal factoren een rol kan spelen bij het niet kunnen of willen ondergaan van nierdonatie bij leven. Deze factoren komen terug in de interviews: · Demografische en medische variabelen · Kennis en informatie · Standpunten en argumenten ten aanzien van nierdonatie bij leven, · Communicatie met de arts en de omgeving · Risicoperceptie · Verwachtingen ten aanzien van de gevolgen voor de persoonlijke relatie tussen donor en ontvanger. ETHISCHE ANALYSE De resultaten van de empirische gedeelte van deze studie dienen als basis voor de ethische analyse. Argumenten zoals gevonden in het empirische gedeelte van de studie worden getoetst op houdbaarheid met behulp van ethische theorieën over de structuur van argumenten.,Wij hebben met name gebruik gemaakt van de theorien zoals die geformuleerd zijn door Toulmin, Rawls en Nagel. BEREIKTE RESULTATEN/NIEUWE INZICHTEN De bereidheid om een nier van iemand in de naaste omgeving te accepteren is zeer hoog voor de patiënten in de onderzoeksgroep: slecht 19% is negatief over donatie bij leven. Het is dus niet zo dat de patiënt in het algemeen niet zou willen. Voor een aantal variabelen vonden we verschillen tussen de onderzoeksgroep en de controlegroep. Een opvallende uitkomst is dat in vrijwel àlle gevallen in de controle groep de communicatie over de donatie gestart wordt vanuit de donor: het al dan niet aangeboden krijgen van een nier lijkt bepalend voor het doorgaan van de (levende donor) transplantatie. Patiënten vinden het erg moeilijk om uit zichzelf over het onderwerp te beginnen. Ethische analyse laat zien dat de argumenten en bezwaren tegen nierdonatie bij leven zoals gevonden in de onderzoeksgroep weerlegbaar zijn. Dit gegeven draagt bij aan de rechtvaardiging van interventies in de situatie van paPURPOSE Living kidney donation offers many advantages, both from a medical and societal point of view. However, there is a group of patients that cannot or will not make use of the living kidney donation program. The purpose of the study ‘Living Kidney donation: psychological and ethical aspects’ is to gain insight into the knowledge and acceptance of this form of kidney transplantation. The group we investigate is the group that actually is eligible for living kidney donation / transplantation, namely (1) patients with end stage renal disease on the transplantation waiting list and (2) the persons in their close environment, the potential donors. Investigating these groups is the strategy to find out if, and under what circumstances, expansion of the living kidney donation program is feasible and ethically acceptable. RESEARCH QUESTIONS The project comprises two research questions. The first research question is: what are the psychological barriers for living kidney donation for the patients and the people in their close environment? The second research question is: what are the moral arguments to deal or actively or passively with the persons in the close environment of the patients who are the potential donors? In other words, to what extent are interventions morally acceptable? DESIGN PATIENTS We have approached the group of patients on the waiting list for a kidney transplant (region of the Erasmus University Medical Center). We asked the patients for permission to approach individuals in their personal environment, the potential donors. If both (patient and relative of patient) agreed on this, we interviewed these potential donors as well. We also included a control group in our study. This group consists of patients and their actual donors who have planned to undergo living kidney donation/transplantation in the near future and had already made arrangements together with their clinicians. INTERVIEW All participants in our study were interviewed by means of a semi-structured interview. Former research has shown various variables that influence willingness to undergo living kidney donation / transplantation. These variables are included in the interview: · Sociodemographic and medical variables · Knowledge and information · Acceptance of, and argument about of living kidney donation · Communication with the specialist and the personal environment · Risk perception · Expectations regarding the personal relationship between patient and donor. ETHICAL ANALYSIS Ethical analysis is based on the results of the empirical part of the study. Reasoning as found in the empirical part of the study is tested for ethical justification, using ethical theory on the structure of argumentation especially the theories as formulated by Toulmin, Rawls and Nagel. BEREIKTE RESULTATEN/NIEUWE INZICHTEN The willingness to accept the offer of a living kidney donor is very high for patients in the group of interest: only 19% has a negative attitude towards ling donation. Thus, it is not a matter of unwillingness of the patients to accept a living kidney donor. We found a number of differences between the group of interest and the control group. A notable finding is that the communication about kidney donation in the control group is almost always initiated by the donor : being offered a kidney (or not) seems to be decisive for either or not pursuing living kidney donation. Patients find it very difficult to bring up the topic them selves. Ethical analysis shows that the arguments or objections against living kidney donation as raised by the group of interest can be refuted. This adds to the moral acceptability of interventions in the situation of patients on the waiting list for transplantation who do not enter the living kidney donation program initially

De Behoefte aan Psychosociale Steun bij Deelnemers aan het Nederlandse Cross-over Transplantatie Programma

Final technical report of the project.The Dutch kidney exchange donation program started in January 2004. A literature review has shown that several factors of the exchange program could influence the psychological well being of participants, such as the loss of the possibility of a “medical excuse” for unwilling donors and the issue of anonymity. However, these factors have not been the subject of empirical study yet. We therefore studied these factors to determine whether additional psychosocial support is necessary for donors and recipients in the Dutch kidney exchange program. We used structured interviews for all 48 donors and recipients that had undergone exchange donation/ transplantation in 2004. A psychologist interviewed the participants before and 3 months after transplantation. We included a comparison group of 48 donors and recipients participating in the regular living kidney donation program. Donors did not experience additional pressure to donate due to the exchange donation. Most participants preferred anonymity between the couples. We found few needs for additional emotional support. In this respect the exchange group did not differ from the comparison group. We conclude that the psychosocial support offered to exchange couples can be comparable to the support normally offered to participants in the regular living kidney donation program

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

Employing quality control and feedback to the EQ-5D-5L valuation protocol to improve the quality of data collection

Objectives: In valuing health states using generic questionnaires such as EQ-5D, there are unrevealed issues with the quality of the data collection. The aims were to describe the problems encountered during valuation and to evaluate a quality control report and subsequent retraining of interviewers in improving this valuation. Methods: Data from the first 266 respondents in an EQ-5D-5L valuation study were used. Interviewers were trained and answered questions regarding problems during these initial interviews. Thematic analysis was used, and individual feedback was provided. After completion of 98 interviews, a first quantitative quality control (QC) report was generated, followed by a 1-day retraining program. Subsequently individual feedback was also given on the basis of follow-up QCs. The Wilcoxon signed-rank test was used to assess improvements based on 7 indicators of quality as identified in the first QC and the QC conducted after a further 168 interviews. Results: Interviewers encountered problems in recruiting respondents. Solutions provided were: optimization of the time of interview, the use of broader networks and the use of different scripts to explain the project’s goals to respondents. For problems in interviewing process, solutions applied were: developing the technical and personal skills of the interviewers and stimulating the respondents’ thought processes. There were also technical problems related to hardware, software and internet connections. There was an improvement in all 7 indicators of quality after the second QC. Conclusion: Training before and during a study, and individual feedback on the basis of a quantitative QC, can increase the validity of values obtained from generic questionnaires

The implementation of mentalization-based treatment for adolescents: a case study from an organizational, team and therapist perspective

Background: Reports on problems encountered in the implementation of complex interventions are scarce in psychotherapy literature. This is remarkable given the inherent difficulties of such enterprises and the associated safety risks for patients involved.Case description: A case study of the problematic implementation process of Mentalization- Based Treatment for Adolescents (MBT-A), a new therapy for 14 to 18 year old youngsters with severe personality disorders, is presented. The implementation process is described and analyzed at an organizational, team and therapist level.Discussion and evaluation: Our analysis shows that problems at all three levels contributed and interacted to make the implementation cumbersome and hazardous.Conclusion: The implementation of complex psychotherapeutic programs for difficult patients could benefit from a structured attention to processes at multiple levels. We therefore propose a new comprehensive heuristic model of treatment integrity. This new model includes organisational, team and therapist adherence to the treatment model as necessary components of treatment integrity in the implementation of complex interventions. The application of this new model of treatment integrity potentially increases the chance of successful implementations and reduces safety risks for first patients enrolling in a new program