Comparative Effect of Collaborative Care, Pain Medication, and Duloxetine in the Treatment of Major Depressive Disorder and Comorbid (Sub)Chronic Pain: Results of an Exploratory Randomized, Placebo-Controlled, Multicenter Trial (CC:PAINDIP).

OBJECTIVE: Evidence exists for the efficacy of collaborative care (CC) for major depressive disorder (MDD), for the efficacy of the consequent use of pain medication against pain, and for the efficacy of duloxetine against both MDD and neuropathic pain. Their relative effectiveness in comorbid MDD and pain has never been established so far. This study explores the effectiveness of CC with pain medication and duloxetine, and CC with pain medication and placebo, compared with duloxetine alone, on depressive and pain symptoms. This study was prematurely terminated because of massive reorganizations and reimbursement changes in mental health care in the Netherlands during the study period and is therefore of exploratory nature. METHODS: Three-armed, randomized, multicenter, placebo-controlled trial at three specialized mental health outpatient clinics with patients who screened positive for MDD. Interventions lasted 12 weeks. Pain medication was administered according to an algorithm that avoids opiate prescription as much as possible, where paracetamol, COX inhibitors, and pregabalin are offered as steps before opiates are considered. Patients who did not show up for three or more sessions were registered as non-compliant. Explorative, intention-to-treat and per protocol, multilevel regression analyses were performed. The trial is listed in the trial registration (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1089; NTR number: NTR1089). RESULTS: Sixty patients completed the study. Patients in all treatment groups reported significantly less depressive and pain symptoms after 12 weeks. CC with placebo condition showed the fastest decrease in depressive symptoms compared with the duloxetine alone group (b = -0.78; p = 0.01). Non-compliant patients (n = 31) did not improve over the 12-week period, in contrast to compliant patients (n = 29). Pain outcomes did not differ between the three groups. CONCLUSION: In MDD and pain, patient's compliance and placebo effects are more important in attaining effect than choice of one of the treatments. Active pain management with COX inhibitors and pregabalin as alternatives to tramadol or other opiates might provide an attractive alternative to the current WHO pain ladder as it avoids opiate prescription as much as possible. The generalizability is limited due to the small sample size. Larger studies are needed.

The ELPAT living organ donor Psychosocial Assessment Tool (EPAT): from 'what' to 'how' of psychosocial screening - a pilot study.

Thorough psychosocial screening of donor candidates is required in order to minimize potential negative consequences and to strive for optimal safety within living donation programmes. We aimed to develop an evidence-based tool to standardize the psychosocial screening process. Key concepts of psychosocial screening were used to structure our tool: motivation and decision-making, personal resources, psychopathology, social resources, ethical and legal factors and information and risk processing. We (i) discussed how each item per concept could be measured, (ii) reviewed and rated available validated tools, (iii) where necessary developed new items, (iv) assessed content validity and (v) pilot-tested the new items. The resulting ELPAT living organ donor Psychosocial Assessment Tool (EPAT) consists of a selection of validated questionnaires (28 items in total), a semi-structured interview (43 questions) and a Red Flag Checklist. We outline optimal procedures and conditions for implementing this tool. The EPAT and user manual are available from the authors. Use of this tool will standardize the psychosocial screening procedure ensuring that no psychosocial issues are overlooked and ensure that comparable selection criteria are used and facilitate generation of comparable psychosocial data on living donor candidates.

The impact of the donors' and recipients' medical complications on living kidney donors' mental health.

A minority of living kidney donors (between 5-25%) have poor psychological outcomes after donation. There is mixed evidence on the influence of medical complications on these outcomes. We examined whether medical complications among donors and recipients predicted changes in donors' mental health (psychological symptoms and well-being) between predonation and 1 year postdonation. One-hundred and forty-five donors completed questionnaires on mental health predonation and 3 and 12 months postdonation. Number of recipient rehospitalizations and donor complications (none; minor; or severe) were obtained from medical records at 3 and 12 months after surgery. Multilevel regression analyses were used to examine the association between medical complications and changes in donors' mental health over time after controlling for sociodemographic characteristics. We found that donor complications (P = 0.003) and recipient rehospitalizations (P = 0.001) predicted an increase in donors' psychological symptoms over time. Recipient rehospitalizations also predicted a decrease in well-being (P = 0.005) over time; however, this relationship became weaker over time. We conclude that medical complications experienced by either the donor or recipient is a risk factor for deterioration in donors' mental health after living kidney donation. Professionals should monitor donors who experience medical complications and offer additional psychological support when needed.

Predicting mental health after living kidney donation: The importance of psychological factors.

OBJECTIVES: Living donor kidney transplantation offers advantages to the patient, however involves risks to the donor. To optimize donors' mental health after donation, we studied the influence of psychological factors on this outcome. Potential predictors were based on models of Lazarus () and Ursin and Eriksen () that describe predictors of mental health mediated by stress. DESIGN: Prospective design. METHODS: Living kidney donors (n = 151) were interviewed before donation and completed questionnaires 2.5 months before and 3 and 12 months post-donation. Using multilevel regression models, we examined whether appraisals, expectations, knowledge, social support, coping, life events, and sociodemographic characteristics predicted psychological symptoms and well-being and whether these relationships were mediated by stress. RESULTS: A greater increase in psychological symptoms over time was found among donors without a partner. Younger age, lack of social support, expectations of interpersonal benefit, lower appraisals of manageability, and an avoidant coping style were related to more psychological symptoms at all time points. The latter three were mediated by stress. No religious affiliation, unemployment, history of psychological problems, less social support, expectations of negative health consequences, and less positive appraisals were related to lower well-being at all time points. CONCLUSIONS: This study identified indicators of a lower mental health status among living kidney donors. Professionals should examine this profile before donation and the need for extra psychological support in relation to the number and magnitude of the identified indicators. Interventions should be focused on the changeable factors (e.g., expectations), decreasing stress/psychological symptoms, and/or increasing well-being. Statement of contribution What is already known on this subject? Until now, research on psychological outcomes after living kidney donation revealed that mental health remained the same for the majority of living kidney donors, while mental health improved or deteriorated for a minority after donation. In reaction to these findings, many psychosocial screening guidelines have been developed for potential donors; however, the components of these guidelines are based on professional opinions and experience rather than on longitudinal empirical data. There is a lack of research that identifies pre-donation donor characteristics that are related to a lower mental health among donors. Such studies are essential in order to tailor psychosocial support during the donation process. What does this study add? Components that are mostly included in psychosocial screening guidelines for potential living kidney donors are not predictive of deterioration, nor increase, in mental health after donation, except for the lack of a partner. Therefore, there is little evidence on the necessity of rejecting potential donors based on these psychological criteria. The following psychological risk factors are predictive of the absolute level of donors' mental health during the donation process: A history of psychological problems, expectations of interpersonal benefit and negative health outcomes, an avoidant coping style, lack of social support, appraisals of the donation process as an unmanageable and/or negative event, a younger age, no religious affiliation, and unemployment. We argue that potential donors should not be rejected for donation based on these factors, but the indicators should be used to identify donors who might be in need for more psychological support.

Exploring Knowledge About Dialysis, Transplantation, and Living Donation Among Patients and Their Living Kidney Donors.

BACKGROUND: In order to make a well-considered decision and give informed consent about renal replacement therapy, potential living kidney donors and recipients should have sufficient understanding of the options and risks. PURPOSE: We aimed to explore knowledge about Dialysis & Transplantation (DT) and Living Donation (LD) among prospective living kidney donors and recipients. METHODS: Eighty-five donors and 81 recipients completed the Rotterdam Renal Replacement Knowledge-Test (R3K-T) 1 day before surgery. The questionnaire was available in various languages. RESULTS: Recipients knew significantly more about DT than donors (p < 0.001); donors knew more about LD than recipients (p < 0.001). A minority of donors (15 %) and recipients (17 %) had a score that was comparable to the knowledge level of the naïve general population. Recipients and donors knew less about DT and LD if their native language was not Dutch. In addition, recipients knew less about DT if they were undergoing pre-emptive transplantation. CONCLUSIONS: We conclude that recipients and donors retain different information. The decision to undergo living donation appears to be not always based on full knowledge of the risks. We recommend that professionals assess knowledge of prospective donors and recipients during the education process using the R3K-T, and extra attention is required for non-native speakers.

Toward a Conceptualization of the Content of Psychosocial Screening in Living Organ Donors: An Ethical Legal Psychological Aspects of Transplantation Consensus.

BACKGROUND: Across Europe, transplant centers vary in the content of the psychosocial evaluation for eligible living organ donors. To identify whether a common framework underlies this variation in this evaluation, we studied which psychosocial screening items are most commonly used and considered as most important in current psychosocial screening programs of living organ donors. METHODS: A multivariate analytic method, concept mapping, was used to generate a visual representation of the "psychosocial" screening items of living kidney and liver donors. A list of 75 potential screening items was derived from a systematic literature review and sorted and rated for their importance and commonness by multidisciplinary affiliated health care professionals from across Europe. Results were discussed and fine-tuned during a consensus meeting. RESULTS: The analyses resulted in a 6-cluster solution. The following clusters on psychosocial screening items were identified, listed from most to least important: (1) personal resources, (2) motivation and decision making, (3) psychopathology, (4) social resources, (5) ethical and legal factors, and (6) information and risk processing. CONCLUSIONS: We provided a conceptual framework of the essential elements in psychosocial evaluation of living donors which can serve as a uniform basis for the selection of relevant psychosocial evaluation tools, which can be further tested in prospective studies.

Predonation psychosocial evaluation of living kidney and liver donor candidates: a systematic literature review.

Evaluating a person's suitability for living organ donation is crucial, consisting not only of a medical but also of a thorough psychosocial screening. We performed a systematic literature review of guidelines, consensus statements, and protocols on the content and process of psychosocial screening of living kidney and liver donor candidates. We searched PubMed, Embase, CINAHL, and PsycINFO until June 22, 2011, following the PRISMA guidelines, complemented by scrutinizing guidelines databases and references of identified publications. Thirty-four publications were identified, including seven guidelines, six consensus statements, and 21 protocols or programs. Guidelines and consensus statements were inconsistent and lacked concreteness for both their content and process, possibly explaining the observed variability in center-specific evaluation protocols and programs. Overall, recommended screening criteria are not evidence-based and an operational definition of the concept "psychosocial" is missing, causing heterogeneity in terminology. Variation also exists on methods used to psychosocially evaluate potential donors. The scientific basis of predonation psychosocial evaluation needs to be strengthened. There is a need for high-quality prospective psychosocial outcome studies in living donors, a uniform terminology to label psychosocial screening criteria, and validated instruments to identify risk factors.

A psychometric analysis of the Rotterdam Renal Replacement Knowledge-Test (R3K-T) using item response theory.

Knowledge is a prerequisite for promoting well-informed decision-making. Nevertheless, there is no validated and standardized test to assess the level of knowledge among renal patients regarding kidney disease and all treatment options. Therefore, the objective of this study was to investigate the psychometric properties of such a questionnaire for use in research and practice. A 30-item list was validated in four groups: (1) 187 patients on dialysis, (2) 82 patients who were undergoing living donor kidney transplantation the following day, (3) the general population of Dutch residents (n = 515) and (4) North American residents (n = 550). The psychometric properties of the questionnaire were examined using multidimensional item response theory (MIRT). Norm references were also calculated. Five items were found to distort ability estimates (Differential item functioning; DIF). MIRT analyses were subsequently carried out for the remaining 25 items. Almost all items showed good discrimination and difficulty parameters based on the fitted model. Two stable dimensions with 21 items were retrieved for which norm references for the Dutch and North American, dialysis and transplantation groups were calculated. This study resulted in a thorough questionnaire, the Rotterdam renal replacement knowledge-test, which enables reliable testing of patient's knowledge on kidney disease and treatment options in clinic and research.

Psychologic functioning of unspecified anonymous living kidney donors before and after donation.

BACKGROUND: There has been discussion regarding the psychologic functioning of living donors who donate their kidney to an unrelated and unknown patient ("unspecified living donors"). This is the first prospective study to investigate group- and individual-level changes in psychologic functioning among a large group of unspecified donors. METHODS: Forty-nine medically and psychologically screened unspecified living kidney donors completed the Symptom Checklist before and after donation. RESULTS: Group-level analysis showed that overall psychologic symptoms increased after donation (P=0.007); the means remained within the average range of the normal population. Individual-level analysis showed that 33 donors showed no statistically significant change, 3 donors showed a statistically significant decrease, and 13 donors showed a statistically significant increase in psychologic symptoms. Two of the latter donors showed a clinically significant increase. CONCLUSIONS: We found more increases in psychologic symptoms than decreases, particularly if follow-up time was longer. However, for almost all donors, these increases were not clinically significant and the clinically significant changes found are comparable with natural fluctuations in psychologic symptoms in the general population. Possibly, the donors underreported their psychologic symptoms before donation to pass the screening. Due to the low level of predonation symptoms reported, regression to the mean could also explain the results. Although we found that changes were not associated with donation-related factors, it is possible that other donation-related factors or other life events not measured have an influence on psychologic functioning. Therefore, further research is needed to investigate whether the fluctuations are related to the donation process.