Improving quality of life in patients with rare autoimmune liver diseases by structured peer-delivered support (Q.RARE.LI): study protocol for a transnational effectiveness-implementation hybrid trial.

BACKGROUND: Psychosocial support is a crucial component of adequate rare disease care, but to date psychosocial support needs of this patient population are insufficiently met. Within Q.RARE.LI, we strive to evaluate the effectiveness of a structured, transdiagnostic, and location-independent psychosocial support intervention in routine care of patients with rare autoimmune liver diseases in five countries and prepare its implementation. METHODS: Within an effectiveness-implementation hybrid trial, we aim to a) investigate the effectiveness of the intervention in routine care in five diverse healthcare systems and b) assess implementation outcomes, examine and prepare the implementation context, and develop country-specific implementation strategies. To assess effectiveness, we will include N = 240 patients with rare autoimmune liver diseases. Within a two-armed randomized controlled trial (allocation ratio 1:1), we will compare structured and peer-delivered psychosocial support in addition to care-as-usual (CAU) with CAU alone. Outcomes will be assessed via electronic database entry prior to intervention, directly after, and at a three-month follow-up. Our primary effectiveness outcome will be mental health-related quality of life at post-assessment. Secondary outcomes include depression and anxiety severity, perceived social support, helplessness, and disease acceptance. Implementation outcomes will be assessed within a mixed-methods process evaluation. In a quantitative cross-sectional survey, we will examine perceived acceptability and feasibility in patients, peer-counselors, and healthcare providers involved in delivery of the intervention. In qualitative focus groups, we will analyze the implementation context and determine barriers and facilitators for implementation with different stakeholders (patients and/or representatives, peer-counselors, healthcare providers, health insurers). Based on these results, we will derive country-specific implementation strategies and develop a concrete implementation plan for each country. DISCUSSION: The intervention is expected to help patients adjust to their disease and improve their mental quality of life. The transdiagnostic and location-independent program has the potential to reach patients for psychosocial support who are usually hard to reach. By preparing the implementation in five countries, the project can help to make low-threshold psychosocial support available to many patients with rare diseases and improve comprehensive healthcare for an often neglected group. TRIAL REGISTRATION: ISRCTN15030282.

Illness cognitions and health-related quality of life in liver transplant patients related to length of stay, comorbidities and complications.

PURPOSE: Illness cognitions regarding helplessness and acceptance are known to play a role in health-related quality of life (HRQoL). Our study examined the evolution of these illness cognitions and the physical (PQoL) and mental QoL (MQoL) in liver transplantation (LT) patients over time in relation to pre- and postoperative clinical factors. METHODS: We performed an analytical cross-sectional study using self-report questionnaires at 4 timeframes: preLT, postLT0-3 m, postLT1y, and postLT2y. T-test was used to identify the influence of different clinical factors related to the LT on postLT2y QoL and illness cognition. Linear mixed models were used to determine evolution. RESULTS: PostLT patients showed significant less helplessness and more acceptance cognitions. PQoL and MQoL decreased postLT0-3 m, then started to increase and are highest at postLT1y. Patients with preLT ascites showed significantly less helplessness postLT2y, while patients with a low preLT MELD score < 20 showed a significant better MQoL postLT2y. Biliary complications and re-transplantation were associated with more helplessness and a worse PQoL postLT1y-2y. Length of stay in ICU and hospital was negatively correlated with illness cognitions and PQoL and MQoL postLT1y. CONCLUSIONS: Our findings confirm that liver transplant patients have improvement of illness cognitions and mental and physical HRQoL at 1 and 2 years after liver transplantation. A postoperative period without complications and with short stay in ICU and in hospital, is important to achieve PQoL and feeling less helpless, while the MQoL is influenced by acceptance and preLT PQoL. Multidisciplinary approach preLT and postLT should be standard care.

Evaluation of the quality of the communication and emotional support during the donation procedure: The use of the donor family questionnaire (DFQ).

PURPOSE: A multi-centric study in Intensive Care units (ICU) and Emergency departments (ED) was designed to evaluate whether the provided communication and emotional support to the family in the context of organ donation met the international recommendations of the European Donor Hospital Education Program (EDHEP). MATERIALS AND METHODS: Using a participatory approach and focus groups, a questionnaire was constructed: Donor Family questionnaire (DFQ). The questionnaire was distributed to 203 families. The data were analysed on item level. RESULTS: Sixty-four families participated, and 89% considered the communication as tactful. Only 24.1% had a separate conversation about passing and donation, which is the recommendation. 88.5% reported they could count on emotional support in the first phase on the ICU/ED. This dropped during the parting phase and the aftercare. The physician is perceived as the most active caregiver in the emotional support during the entire procedure. CONCLUSIONS: The DFQ is a useful instrument to evaluate the donor procedure. The physician is important in the first phases of the donor procedure for the medical explanation. Other disciplines could be more involved in the following phases to assure enough emotional support, but this issue requires further exploration.

Quality of life after liver transplantation: State of the art.

Quality of life (QoL) after deceased donor liver transplantation is increasingly recognized as a major outcome parameter. We reviewed recent publications in this rapidly evolving field in order to summarize recent achievements in the field and to define opportunities and perspectives for research and improvement of patient care. QoL does improve after liver transplantation according to a typical pattern. During the first year, there is a significant improvement in QoL. After one year, the improvement does stabilise and tends to decline slightly. In addition to the physical condition, different psychological parameters (such as depression, anxiety, sexual function) and sociodemographic elements (professional state, sex, marital state) seem to impact QoL. Opportunities for further research are the use of dedicated questionnaires and identification of influencing factors for QoL.

Facial transplantation in a blind patient: psychologic, marital, and family outcomes at 15 months follow-up.

BACKGROUND: Quality of life has frequently been reported to improve after vascularized composite allotransplantation of the face. However, psychosocial functioning of the partner or of particular patient groups such as blind patients are until now less well investigated. OBJECTIVE: The aim of this study is to investigate psychologic, marital, and family functioning of a blind 54-year-old patient, Mr. A, and his partner after facial transplantation. METHODS: Depressive and anxiety symptoms, hopelessness, personality, coping, resilience, illness cognitions, marital support, dyadic adjustment, family functioning, and quality of life of Mr. A and his partner were assessed before and after facial transplantation and at 15 months follow-up. Reliable change index (RCI) was further calculated to evaluate the magnitude of change. RESULTS: Most psychologic, marital, and family scores of both Mr. A and his partner were within a normative and healthy range before and after transplant and at 15 months follow-up. Resilience (RCI: 3.6), affective responsiveness (RCI: -3.6), and disease benefits (RCI: 2.6) of Mr. A further improved at 15 months follow-up whereas the physical quality of life (RCI: -14.8) strongly decreased. Only marital support (RCI: -2.1) and depth (RCI: -2.0) of the partner decreased at 15 months. CONCLUSIONS: The results of this study point to positive psychosocial outcomes in a blind patient after facial transplantation. Further, they may underscore the importance of good psychosocial functioning before transplantation of both partners and of their involvement in psychologic and psychiatric treatment. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, V.

Cognitive behavior therapy in patients with chronic fatigue syndrome: the role of illness acceptance and neuroticism.

OBJECTIVE: Increasing the quality of life (QoL) of patients with chronic fatigue is challenging because recovery is seldom achieved. Therefore, it is important to identify processes that improve QoL. This study examined the extent of improvement related to cognitive behavior group therapy (CBT), and whether improvement is affected by initial levels of acceptance and neuroticism. METHODS: Eighty CFS patients followed CBT, and self-reported (pre-post design) on mental and physical QoL (MQoL and PQoL), fatigue, acceptance, and neuroticism. The extent of improvement was analyzed using t-tests, effect sizes, and clinically significant change criteria. Whether acceptance and neuroticism at baseline predicted changes was analyzed by means of correlation and regression analyses. RESULTS: Significant improvement was found for all variables. The effect size for MQoL and PQoL was small; for acceptance and fatigue, effect size was moderate. About 20% (MQoL) to 40% (fatigue) of the participants clinically improved. Pre-treatment level of acceptance was negatively correlated with changes in MQoL, not with PQoL changes. Neuroticism pre-treatment was positively related with MQoL changes. Regression analysis showed an effect of acceptance on changes in MQoL beyond the effect of neuroticism. CONCLUSIONS: Although CBT is an evidence-based treatment, the sizes of the effects are often small regarding QoL. Our study also revealed small effect sizes. Our study showed that patient characteristics at baseline were significantly associated with MQoL outcome; indicating that CFS patients with high neuroticism or with a low acceptance show more improvement in MQoL. We propose to specifically target acceptance and neuroticism before treatment in order to maximize clinical relevance.

Improving quality of life in patients with chronic kidney disease: influence of acceptance and personality.

BACKGROUND: A low health-related quality of life (HQL) is associated with the evolution of chronic kidney disease (CKD) and mortality in patients in end-stage of the disease. Therefore research on psychological determinants of HQL is emerging. We investigate whether acceptance of the disease contributes to a better physical and mental health-related quality of life (PHQL and MHQL). We also examine the impact of personality characteristics on acceptance, PHQL and MHQL. METHODS: In this cross-sectional study, patients from an outpatient clinic of nephrology completed self-report questionnaires on quality of life, acceptance and personality characteristics. We performed correlations, regression analyses and a path analysis. RESULTS: Our sample of 99 patients had a mean duration of CKD of 10.81 years and a mean estimated Glomerular Filtration Rate (eGFR) by Modification of Diet in Renal Disease (MDRD)-formula of 34.49 ml/min (SD 21.66). Regression analyses revealed that acceptance had a significant positive contribution to the prediction of PHQL and MHQL. Neuroticism was negatively associated with acceptance and MHQL. Path analysis showed that 37% of the total effect of neuroticism on MHQL was mediated by acceptance. CONCLUSIONS: Acceptance is an important positive variable in accounting for HQL, however, clinicians must be aware that if patients have a high level of neuroticism they are likely to have more difficulties with this coping strategy. These results provide a better understanding of psychological determinants of HQL in CKD, which can initiate another approach of these patients by nephrologists, specific psychological interventions, or other supporting public health services.

Mental quality of life in chronic fatigue is associated with an accommodative coping style and neuroticism: a path analysis.

PURPOSE: An accommodative coping style (e.g. acceptance) is related to a better mental health-related quality of life (MHQL) in patients with chronic fatigue syndrome (CFS). We want to explore whether neuroticism is predictive for this coping style and MHQL. Secondly we want to explore the relation between acceptance and physical health-related quality of life (PHQL) and expect that illness-related variables such as fatigue severity and duration are related to PHQL. METHOD: In this cross-sectional study, 117 patients with chronic fatigue syndrome from an outpatient internal medicine clinic completed self-report questionnaires on quality of life (SF-36), acceptance (ICQ), personality traits (NEO-FFI) and fatigue severity (CIS). RESULTS: Regression analyses showed that neuroticism and acceptance are predictors of MHQL (38% of the variance was explained). The path analysis showed that acceptance mediates between neuroticism and MHQL and that PHQL is related to MHQL. PHQL is related to fatigue severity and duration, but not to neuroticism and acceptance. CONCLUSION: Stimulating an 'accepting accommodative coping style' within the treatment for CFS is important in improving mental quality of life. Our results suggest that neuroticism may be negatively related to acceptance and MHQL. This findings support the idea that a psychological diagnostic workout with special attention to personality traits in relation to their coping style is recommended in order to choose the most appropriate therapeutic approach in this population.

Acceptance of pain is an independent predictor of mental well-being in patients with chronic pain: empirical evidence and reappraisal.

This paper reports upon: (1) the value of acceptance of pain in predicting well-being in patients suffering from chronic pain and (2) the construct validity of acceptance by comparing two questionnaires designed to measure acceptance (the Chronic Pain Acceptance Questionnaire, CPAQ, unpublished doctoral dissertation, University of Nevada, Reno, NV, 1992 and the Illness Cognitions Questionnaire, ICQ, J Consult Clin Psychol 69 (2001) 1026). The results of two independent cross-sectional studies are reported. Study 1 included 120 patients seeking help in tertiary care settings. In Study 2, 66 patients were recruited from a self-support group for fibromyalgia patients and from a pain clinic. Both studies revealed that acceptance of pain predicted mental well-being beyond pain severity and pain catastrophizing, but did not account for physical functioning. In both instruments, it was found that acceptance of pain was strongly related to engagement in normal life activities and the recognition that pain may not change. Acceptance in both instruments was strongly related to a cognitive control over pain. Study 2 further revealed that the correlation between the CPAQ and the ICQ is moderate, indicating that both instruments measured different aspects of acceptance. It is concluded that acceptance of chronic pain is best conceived of as the shift away from pain to non-pain aspects of life, and the shift away from a search for a cure with an acknowledgement that pain may not change.