Predictors of falls and hospital admissions in people with cognitive impairment in day-care: role of multimorbidity, polypharmacy, and potentially inappropriate medication.

BACKGROUND: Multimorbidity, polypharmacy, and potentially inappropriate medication (PIM) pose challenges for the care of people with cognitive impairment. The aim of the present study is to explore whether multimorbidity, polypharmacy, and PIM predict falls and hospital admissions in a sample of people with cognitive impairment in day-care centers in Germany. METHODS: We used data from the German day-care study (multicenter longitudinal study, n = 433). Multimorbidity was defined as ≥ 2 chronic diseases. Polypharmacy was defined as prescriptions to ≥ 5 drugs. Potentially inappropriate medication was defined as scoring on the PRISCUS list. Binary logistic regression analyses were computed to determine whether multimorbidity, polypharmacy, and potentially inappropriate medication at t0 predicted falls and hospital admissions as outcomes at t1 (six months later). RESULTS: The rate of multimorbidity and polypharmacy was 87.8% and 60.3%, respectively. 15.9% of the people with cognitive impairment received PIM / PRISCUS-listed drugs, 43.6% ACB-listed drugs, and 52.7% CNS depressant drugs. Falls and hospital admissions during follow-up were prevalent in 19.4% and 24.7% of the people with cognitive impairment. Both were significantly predicted by the total number of drugs (falls: OR = 1.152, p = 0.001, overall model: p < 0.001; hospital admissions: OR = 1.103, p = 0.020, overall model: p = 0.001), even if regression analyses were controlled for the number of comorbidities. CONCLUSIONS: Polypharmacy and potentially inappropriate medication are highly prevalent in people with cognitive impairment in German day-care centers. The number of drugs and appropriateness of medication seem to be crucial for the risk of falls and hospital admissions. Polypharmacy and PIM should be critically reviewed by healthcare providers and avoided as much as and whenever possible. TRIAL REGISTRATION: ISRCTN16412551, 30 July 2014, registered partly retrospectively.

Predictors of institutionalization in users of day care facilities with mild cognitive impairment to moderate dementia.

BACKGROUND: Most people with dementia wish to remain at home for as long as possible. Therefore, it is important to know the predictors of institutionalization, especially those that can be influenced. The aim of the present study is to identify predictors of the institutionalization of people with mild cognitive impairment (MCI) to moderate dementia who attend day care facilities (DCFs) throughout Germany. METHODS: This study is a secondary analysis of longitudinal data from 371 dyads comprising a cognitively impaired care receiver (CR) and a caregiver (CG). The data were collected in DCFs and via telephone interviews at three measurement points. To investigate the extent to which 16 variables could predict the institutionalization of the CRs between the 6- and 12-month follow-up, in the first step bivariate Cox regressions were calculated. In the second step, significant predictors were included in a model using multivariate Cox regression. RESULTS: Between the 6- and 12-month evaluations, 39 CRs moved into an institution. The risk of institutionalization of people with MCI to moderate dementia attending a DCF increased significantly (p < .05) when the CRs showed more neuropsychiatric symptoms (Hazard ratio (HR) = 1.237), when the CRs and their CGs did not live together in the same house (HR = 2.560), or when the care level of the CRs is low (HR = 2.241). CONCLUSIONS: Neuropsychiatric symptoms could be a possible starting point for therapeutic interventions that are designed to delay or prevent institutionalization. CG who do not live with their CR in the same house and CG who care for a CR with impairment in performing daily routine tasks care are particularly likely to make the decision to institutionalize the CR. For this group, advice and support are particularly important. TRAIL REGISTRATION: ISRCTN16412551 .

The DemWG study: reducing the risk of hospitalisation through a complex intervention for people with dementia and mild cognitive impairment (MCI) in German shared-housing arrangements: study protocol of a prospective, mixed-methods, multicentre, cluster-randomised controlled trial.

INTRODUCTION: Shared-housing arrangements (SHAs) are small, home-like care environments in Germany. Residents are predominantly people with dementia. The risk for all-cause hospitalisation is consistently higher for people with dementia compared with people without dementia and there is currently no evidence-based intervention to reduce the risk of hospitalisation. Thus, the DemWG study investigates whether a complex intervention is effective in reducing hospitalisation (primary outcome), behavioural and psychological symptoms of dementia and falls and for stabilising cognitive functioning and quality of life in people with dementia and mild cognitive impairment (MCI) in German SHAs. METHODS AND ANALYSIS: Based on the UK Medical Research Council framework 'Developing and evaluating complex interventions', a prospective, mixed-methods, multicentre, cluster-randomised controlled trial combining primary and secondary data analyses as well as quantitative and qualitative research methods is being conducted. The intervention consists of three parts: (A) education of nursing staff in SHAs; (B) awareness raising and continuing medical education (CME) of general practitioners; (C) multicomponent non-pharmacological group intervention MAKS-mk+ ('m'=motor training; 'k'=cognitive training; '+'=fall prevention) for people with dementia and MCI. Randomisation is stratified by the German federal states and type of setting (rural vs urban). Neither the trained professionals nor the participants are blinded. Data are collected at baseline and after 6, 12 and 18 months with standardised instruments. Quantitative data will be analysed by multivariate analyses according to the general linear model, qualitative data using qualitative content analysis. Recruitment is still ongoing until 31 December 2020. ETHICS AND DISSEMINATION: All procedures were approved by the Ethics Committee of the University of Bremen (Ref. 2019-18-06-3). Informed consent will be obtained before enrolment of participants. Due to findings of previous randomised controlled trials, serious adverse events are not expected. Results will be disseminated in peer-reviewed journal publications and conference presentations. TRIAL REGISTRATION NUMBER: ISRCTN89825211.

Psychosocial impact of prognostic genetic testing in uveal melanoma patients: a controlled prospective clinical observational study.

BACKGROUND: The risk of metastases in uveal melanoma can accurately be estimated through genetic analysis of the tumor. A growing number of patients decide to receive information on their prognosis, although this can be extremely burdensome. Studies on the psychosocial impact of testing are sparse. The objective of this study was to examine traits of patients opting for prognostication, to investigate its psychosocial impact and the use of psycho-oncological services over time. We further examined characteristics of patients utilizing these services and risk factors of prolonged psychological distress. DESIGN AND METHODS: This study is a non-randomized controlled prospective clinical observational trial. Patients availing for prognostication formed the test group, while those who opted out constituted the observational group. The psychosocial impact of genetic testing was assessed with the following variables: resilience, social support, fear of tumor progression, depression, general distress, health-related quality of life, estimation of the perceived risk, and the utilization of psycho-oncological interventions. Data were assessed at five different time points over a period of 12 months. We applied binary logistic regression analysis, multiple linear regressions and a mixed model. RESULTS: Of 175 patients, 63 decided to obtain prognostic information. Treatment method (enucleation > brachytherapy), lower social support and higher general distress could significantly predict patient's choice for prognostic testing. After result announcement, perceived risk of metastases was significantly increased in patients with poor prognosis, while it decreased in those with good prognosis. Overall, a significant decrease over time appeared concerning fear of progression, general distress, depression and anxiety. Mental quality of life increased over time. The utilization of psycho-oncological interventions increased significantly after prognostication; however, this was equivalent in the test and observational groups. Female sex, higher general distress and higher anxiety predicted greater use of psycho-oncological interventions. DISCUSSION: Availing of prognostic testing is not associated with poorer subsequent psychological well-being. It rather may help to alleviate distress and promote a more realistic risk perception. However, psychological support should be available to all patients, independent of prognosis and treatment, especially considering that patients with low social support and high distress increasingly opt for prognostication.

Responder Analysis of a Multicomponent Non-Pharmacological Intervention (MAKS) for People With Cognitive Impairment in the German Day-Care Study (DeTaMAKS).

Background: Multicomponent non-pharmacological therapies have been shown to be effective at reducing cognitive symptoms and slowing deterioration in abilities to perform activities of daily living (ADL) in individuals with cognitive impairment. However, little is known about response rates and predictors of response. Methods: We used data from the German day-care study (DeTaMAKS; De = dementia, Ta = Tagespflege/day-care, M = motor stimulation, A = activities of daily living stimulation, K = k/cognitive stimulation, S = social stimulation; n = 362), which was based on a cluster-randomized trial of the non-pharmacological, multicomponent, anti-dementia MAKS therapy for people with cognitive impairment in day-care centers. We investigated response (defined as improvement or no deterioration) for three different response criteria: cognition via Mini-Mental State Examination (MMSE) score, ADL via Erlangen Test of Activities of Daily Living in Persons with Mild Dementia or Mild Cognitive Impairment (ETAM) score, and behavioral and psychological symptoms of dementia (BPSD) via Neuropsychiatric Inventory Questionnaire (NPI-Q) score. In addition, we calculated the number needed to treat (NTT) and response rates according to net gain analyses. Results: For all three criteria, the response rates were higher in the intervention group than in the control group (chi2 test: p = 0.058 to p = 0.003). Compared with non-responders, responders according to cognition had higher ETAM scores (= better ADL abilities) at baseline; responders according to ADL had lower ETAM scores (= poorer ADL abilities) at baseline; and responders according to BPSD had higher NPI-Q scores (= more BPSD) at baseline. Classification rates based on these predictors ranged from 60.6 to 68.3%. Discussion: The response rates to the non-pharmacological MAKS therapy were greater than those reported for anti-dementia drugs. There were only a few differences between responders and non-responders. Because of the low classification rates, these variables had only a small impact on response predictions. Therefore, there are no empirically substantiated selection criteria for the application of MAKS therapy in facilities. Clinical Trial Registration: www.ClinicalTrials.gov, identifier ISRCTN16412551.

Can brief telephone interventions reduce caregiver burden and depression in caregivers of people with cognitive impairment? - long-term results of the German day-care study (RCT).

BACKGROUND: Day-care and telephone counseling have been discussed as effective support measures for caregivers of people with cognitive impairment. METHODS: In a two-arm cluster-randomized trial involving multicomponent therapy for cognitively impaired persons in day-care centers and telephone counseling for their caregivers versus treatment as usual (TAU), we investigated long-term effects on caregivers' burden and depressiveness. Person-caregiver dyads involving home-dwelling persons with MCI, mild dementia, or moderate dementia were eligible. Day-care centers were randomized into an intervention group (IG) or a control group (CG). Outcome assessors were blinded. Out of 359 caregivers who had completed a 6-month intervention phase (nIG = 205, nCG = 154), a total of 304 of them were available at the 12-month follow-up (nIG = 173, nCG = 131). Instruments for assessing were the Burden Scale for Family Caregivers - short version (BSFC-s) (caregiver burden) and the Well-Being Index Score (WHO-5) (depressiveness). Mixed ANOVAs were used for the main analyses; descriptive statistics and subgroup analyses were additionally performed; secondary analyses involved multiple linear regressions for the main outcomes that were significant in the unadjusted main analysis. RESULTS: At follow-up, crude mean differences showed a nonsignificant advantage for the IG in caregiver burden [IG: -.20 (SD = 5.39) vs. CG: .76 (SD = 5.49), p = .126, d = .177] and depressiveness (reverse scored) [IG: -.05 (SD = 5.17) vs. CG: -.98 (SD = 5.65), p = .136, d = .173]. For caregiver burden, a mixed ANOVA resulted in significant main effects of group (F (1, 302) = 4.40; p = .037) and time (F (1.88, 568.96) = 3.56; p = .032) but not a significant interaction. The largest effects were found for the "mild dementia" subgroup (d = .443 for caregiver burden and d = .520 for depressiveness). DISCUSSION: Positive long-term effects of a combined intervention involving telephone counseling for caregivers and multicomponent activation for patients were observed especially for mild dementia. However, the treatment effects washed out after the intervention ended. TRIAL REGISTRATION: ISRCTN16412551 (date: 30 July 2014, retrospectively).

Psychological processing of a kidney transplantation, perceived quality of life, and immunosuppressant medication adherence.

Introduction: Though psychosocial well-being and quality of life generally improve after transplantation, a relevant proportion of patients suffers from psychosocial problems. Further analysis of the psychological coping after kidney transplantation is needed to identify patients at risk. The aim of this study was to examine the psychological response after kidney transplantation and its associations with health-related quality of life and immunosuppressant medication adherence. Materials and methods: The coping process after kidney transplantation was investigated with the Transplant Effects Questionnaire (TxEQ; subscales: worry, guilt, disclosure, adherence, responsibility) in 267 adult kidney transplant recipients ≥12 months post-transplantation. Furthermore, perceived health-related quality of life, self-reported immunosuppressant medication adherence, and sub-therapeutic immunosuppressant trough levels as biological markers of adherence were assessed. Results: Patients showed moderate scores concerning the subscales "worry", "guilt", and "responsibility" as well as high scores concerning "disclosure". Except for "adherence", all TxEQ subscales were associated with mental, but not with physical health-related quality of life and self-reported adherence. Sub-therapeutic immunosuppressant trough levels were significantly associated only with the TxEQ subscale "worry". Conclusions: The present results suggest a conditional structure in which mental health-related quality of life is negatively associated with worries, guilt, and responsibility and positively with disclosure. Adherence seems to be a complex behavior, which is not necessarily directly associated with the psychological processing of organ transplantations. As mental health-related quality of life is related to this psychological processing, the TxEQ could be used as a screening tool for problematic psychological processing after kidney transplantation.

Psychosocial Variables Associated with Immunosuppressive Medication Non-Adherence after Renal Transplantation.

INTRODUCTION: Non-adherence to immunosuppressive medication is regarded as an important factor for graft rejection and loss after successful renal transplantation. Yet, results on prevalence and relationship with psychosocial parameters are heterogeneous. The main aim of this study was to investigate the association of immunosuppressive medication non-adherence and psychosocial factors. METHODS: In 330 adult renal transplant recipients (≥12 months posttransplantation), health-related quality of life, depression, anxiety, social support, and subjective medication experiences were assessed, and their associations with patient-reported non-adherence was evaluated. RESULTS: 33.6% of the patients admitted to be partially non-adherent. Non-adherence was associated with younger age, poorer social support, lower mental, but higher physical health-related quality of life. There was no association with depression and anxiety. However, high proportions of clinically relevant depression and anxiety symptoms were apparent in both adherent and non-adherent patients. CONCLUSION: In the posttransplant follow-up, kidney recipients with lower perceived social support, lower mental and higher physical health-related quality of life, and younger age can be regarded as a risk group for immunosuppressive medication non-adherence. In follow-up contacts with kidney transplant patients, physicians may pay attention to these factors. Furthermore, psychosocial interventions to optimize immunosuppressive medication adherence can be designed on the basis of this information, especially including subjectively perceived physical health-related quality of life and fostering social support seems to be of importance.

Patient-reported non-adherence and immunosuppressant trough levels are associated with rejection after renal transplantation.

BACKGROUND: Different measures of non-adherence to immunosuppressant (IS) medication have been found to be associated with rejection episodes after successful transplantation. The aim of the current study was to investigate whether graft rejection after renal transplantation is associated with patient-reported IS medication non-adherence and IS trough level variables (IS trough level variability and percentage of sub-therapeutic IS trough levels). METHODS: Patient-reported non-adherence, IS trough level variability, percentage of sub-therapeutic IS trough levels, and acute biopsy-proven late allograft rejections were assessed in 267 adult renal transplant recipients who were ≥12 months post-transplantation. RESULTS: The rate of rejection was 13.5%. IS trough level variability, percentage of sub-therapeutic IS trough levels as well as patient-reported non-adherence were all significantly and positively associated with rejection, but not with each other. Logistic regression analyses revealed that only the percentage of sub-therapeutic IS trough levels and age at transplantation remained significantly associated with rejection. CONCLUSIONS: Particularly, the percentage of sub-therapeutic IS trough levels is associated with acute rejections after kidney transplantation whereas IS trough level variability and patient-reported non-adherence seem to be of subordinate importance. Patient-reported non-adherence and IS trough level variables were not correlated; thus, non-adherence should always be measured in a multi-methodological approach. Further research concerning the best combination of non-adherence measures is needed.

Standardized Evaluation of Candidates Before Liver Transplantation With the Transplant Evaluation Rating Scale.

BACKGROUND: The Transplant Evaluation Rating Scale (TERS) was developed to provide a standardized evaluation of the psychosocial functioning of patients, before transplantation. Yet, the first 2 items of the TERS are based on psychiatric diagnoses referring to Diagnostic and Statistical Manual (DSM)-III-R, which leads to a duplication of disorder-specific and symptom-specific contents, that makes it complex to rate. Moreover, the TERS has not been updated to DSM revisions and DSM is not used for the official clinical routine documentation in several European countries. OBJECTIVE: The objective of this study was, therefore, to investigate the psychometric properties of a diagnoses-corrected version of the TERS (items 1 and 2 omitted). METHODS: In 85 patients awaiting liver transplantation, the discrimination capacities, predictive value, convergent validity, and interrater reliability of the original version (TERS10) and the diagnoses-corrected version (TERS8) were analyzed. RESULTS: In both versions, patients with psychiatric diagnoses (69.4%) exhibited significantly higher TERS mean values than patients without psychiatric disorders. This also held for patients who were temporarily not found eligible for transplantation in the psychosocial evaluation (25.9%) compared with patients who were eligible for listing for transplantation. Furthermore, the area under the curve was >0.90 for both versions and a cutoff of 32.25 is suggested for TERS8 (sensitivity of 90.9% and specificity of 87.3%). CONCLUSIONS: Our results substantiate good psychometric properties of the revised (diagnoses corrected) TERS, which is of great benefit for standardized psychosocial evaluation before liver transplantation. Further, validation of TERS8 and its cutoff in other samples of (liver) transplantation patients is needed.

Age changes in pain perception: A systematic-review and meta-analysis of age effects on pain and tolerance thresholds.

Demographic changes, with substantial increase in life expectancy, ask for solid knowledge about how pain perception might be altered by aging. Although psychophysical studies on age-related changes in pain perception have been conducted over more than 70 years, meta-analyses are still missing. The present meta-analysis aimed to quantify evidence on age-related changes in pain perception, indexed by pain thresholds and pain tolerance thresholds in young and older healthy adults. After searching PubMed, Google Scholar and PsycINFO using state-of-art screening (PRISMA-criteria), 31 studies on pain threshold and 9 studies assessing pain tolerance threshold were identified. Pain threshold increases with age, which is indicated by a large effect size. This age-related change increases the wider the age-gap between groups; and is especially prominent when heat is used and when stimuli are applied to the head. In contrast, pain tolerance thresholds did not show substantial age-related changes. Thus, after many years of investigating age-related changes in pain perception, we only have firm evidence that aging reduces pain sensitivity for lower pain intensities.

Psychological Predictors of Acute Postoperative Pain After Hysterectomy for Benign Causes.

OBJECTIVES: Psychological parameters have been shown to contribute significantly to the development of acute postoperative pain (APOP). For the prediction of APOP in chest malformation patients and cancer patients, we found pain-specific psychological predictors to be of higher relevance than general psychological predictors. The current study aims to further substantiate these findings. MATERIALS AND METHODS: In a sample of 73 middle-aged hysterectomy patients, 3 predictor sets were assessed 1 day before surgery: attentional biases (toward pain-related, social threat, and positive words in a dot-probe task), pain-related emotions and cognitions (pain anxiety, pain catastrophizing, and pain hypervigilance), and affective state variables (depression and somatization). APOP intensity rated 2 to 3 days after surgery and analgesic consumption during the first 48 postoperative hours were used as outcome measures. RESULTS: APOP intensity ratings were significantly explained by their best single predictors in a multiple regression analysis: social threat words of the dot-probe task, pain anxiety, and somatization (14.7% of explained variance). When comparing standardized ß coefficients, pain-specific psychological predictors appeared to be of higher explanatory relevance than general psychological predictors. In contrast, analgesic consumption could not be significantly predicted by the psychological variables. DISCUSSION: Hysterectomy patients at risk for high APOP intensity could be characterized by the psychological variables used, whereas their predictive value for analgesic consumption was limited. The high predictive potency of pain-specific psychological variables should be considered for further improvement of pain management and prevention, because pain-specific variables such as pain anxiety can be the target of focal psychological interventions when preparing for surgery.

Psychosocial impact of prognostic genetic testing in the care of uveal melanoma patients: protocol of a controlled prospective clinical observational study.

BACKGROUND: Uveal melanoma patients with a poor prognosis can be detected through genetic analysis of the tumor, which has a very high sensitivity. A large number of patients with uveal melanoma decide to receive information about their individual risk and therefore routine prognostic genetic testing is being carried out on a growing number of patients. It is obvious that a positive prediction for recidivism in the future will emotionally burden the respective patients, but research on the psychosocial impact of this innovative method is lacking. The aim of the current study is therefore to investigate the psychosocial impact (psychological distress and quality of life) of prognostic genetic testing in patients with uveal melanoma. DESIGN AND METHODS: This study is a non-randomized controlled prospective clinical observational trial. Subjects are patients with uveal melanoma, in whom genetic testing is possible. Patients who consent to genetic testing are allocated to the intervention group and patients who refuse genetic testing form the observational group. Both groups receive cancer therapy and psycho-oncological intervention when needed. The psychosocial impact of prognostic testing is investigated with the following variables: resilience, social support, fear of tumor progression, depression, general distress, cancer-specific and general health-related quality of life, attitude towards genetic testing, estimation of the perceived risk of metastasis, utilization and satisfaction with psycho-oncological crisis intervention, and sociodemographic data. Data are assessed preoperatively (at initial admission in the clinic) and postoperatively (at discharge from hospital after surgery, 6-12 weeks, 6 and 12 months after initial admission). Genetic test results are communicated 6-12 weeks after initial admission to the clinic. DISCUSSION: We created optimal conditions for investigation of the psychosocial impact of prognostic genetic testing. This study will provide information on the course of disease and psychosocial outcomes after prognostic genetic testing. We expect that empirical data from our study will give a scientific basis for medico-ethical considerations.