The Mental Health Quality of Life Questionnaire (MHQoL): development and first psychometric evaluation of a new measure to assess quality of life in people with mental health problems.

PURPOSE: The purpose of this study was to develop and psychometrically evaluate a new quality of life measure for use in people with mental health problems-the Mental Health Quality of Life questionnaire (MHQoL). METHODS: The MHQoL dimensions were based on prior research by Connell and colleagues, highlighting the seven most important quality of life dimensions in the context of mental health. Items were generated following a systematic review we performed and through inviting expert opinion. A focus group and an online qualitative study (N = 120) were carried out to assess the face and content validity of the MHQoL. The MHQoL was further tested for its internal consistency, convergent validity, known-group validity and test-retest reliability among mental healthcare service users (N = 479) and members of the general population (N = 110). RESULTS: The MHQoL consists of a descriptive system (MHQoL-7D), including s items covering seven dimensions (self-image, independence, mood, relationships, daily activities, physical health, future) and a visual analogue scale of general psychological well-being (MHQoL-VAS). Internal consistency was high (Cronbach's ∝ = 0.85) and correlations between MHQoL-7D scores and related measures (EQ-5D-5L, MANSA, ICECAP-A, and BSI) supported convergent validity. The intraclass correlation coefficient of the MHQoL-7D sum score for test-retest reliability was 0.85. Known-group validity was supported by the ability to detect significant differences in MHQoL-7D levels between service users and the general population, and between groups with different levels of psychological distress. CONCLUSION: The MHQoL demonstrated favourable psychometric properties and showed promise as a simple and effective measure to assess quality of life in people with mental health problems.

Instruments to assess quality of life in people with mental health problems: a systematic review and dimension analysis of generic, domain- and disease-specific instruments.

OBJECTIVES: The importance of economic evaluations of mental healthcare interventions is increasingly recognized. Despite the multitude of available quality of life instruments, concerns have been raised regarding the content validity of these instruments, and hence suitability for use in mental health. The aim of this paper, therefore, was to assess the content validity and the suitability of existing quality of life instruments for use in economic evaluations in mental health problems. METHODS: In order to identify available quality of life instruments used in people with mental health problems, a systematic review was performed using the Embase, Medline and PsycINFO databases (time period January 2012 to January 2018). Two reviewers independently assessed study eligibility and executed data extraction. The evaluation framework of Connell and colleagues was used to assess whether the identified quality of life instruments cover the dimensions valued highly by people with mental health problems. Two reviewers independently mapped the content of each identified instrument onto the evaluation framework and indicated the extent to which the instrument covered each of the dimensions of the evaluation framework. RESULTS: Searches of databases yielded a total of 5727 references. Following duplicate removal and double-independent screening, 949 studies were included in the qualitative synthesis. A total of 44 unique quality of life instruments were identified, of which 12 were adapted versions of original instruments. The best coverage of the dimensions of the evaluation framework of Connell and colleagues was by the WHOQOL-100, S-QoL, SQLS, EDQoL, QLI and the IMHQOL, but none fully covered all dimensions of the evaluation framework. CONCLUSIONS: The results of this study highlight the multitude of available quality of life instruments used in people with mental health problems and indicate that none of the available quality of life instruments fully cover the dimensions previously found to be important in people with mental health problems. Future research should explore the possibilities of refining or expanding existing instruments as well as the development and testing of new quality of life instruments to ensure that all relevant quality of life dimensions for people with mental health problems are covered in evaluations.

Interventions that Facilitate Shared Decision-Making in Cancers with Active Surveillance as Treatment Option: a Systematic Review of Literature.

PURPOSE OF REVIEW: Medical decisions concerning active surveillance are complex, especially when evidence on superiority of one of the treatments is lacking. Decision aids have been developed to facilitate shared decision-making on whether to pursue an active surveillance strategy. However, it is unclear how these decision aids are designed and which outcomes are considered relevant. The purpose of this study is to systematically review all decision aids in the field of oncological active surveillance strategies and outcomes used by authors to assess their efficacy. RECENT FINDINGS: A search was performed in Embase, Medline, Web of Science, Cochrane, PsycINFO Ovid and Google Scholar until June 2019. Eligible studies concerned interventions aiming to facilitate shared decision-making for patients confronted with several treatment alternatives, with active surveillance being one of the treatment alternatives. Twenty-three eligible articles were included. Twenty-one articles included patients with prostate cancer, one with thyroid cancer and one with ovarian cancer. Interventions mostly consisted of an interactive web-based decision aid format. After categorization of outcomes, seven main groups were identified: knowledge, involvement in decision-making, decisional conflict, treatment preference, decision regret, anxiety and health-related outcomes. Although active surveillance has been implemented for several malignancies, interventions that facilitate shared decision-making between active surveillance and other equally effective treatment alternatives are scarce. Future research should focus on developing interventions for malignancies like rectal cancer and oesophageal cancer as well. The efficacy of interventions is mostly assessed using short-term outcomes.

Randomized Controlled Trial of a Spectacle Lens for Macular Degeneration.

SIGNIFICANCE: E-Scoop, a spectacle lens, provides no clinically relevant improvements on quality of life, visual acuity, and contrast sensitivity for patients with AMD. Because patients' burden is high and therapeutic options are scarce, the incentive to develop effective vision rehabilitation interventions remains. PURPOSE: Patients with AMD experience low quality of life due to vision loss, despite angiogenesis inhibitor interventions that slow down progression for some patients. E-Scoop, which includes low-power prisms, 6% magnification, yellow tint, and antireflection coating, might aid in daily activities by improving distance viewing. Separately, these features have little proven effectiveness. E-Scoop has not been formally tested. This study aimed to determine the impact of E-Scoop on quality of life and the effect on visual acuity and contrast sensitivity. METHODS: In this randomized controlled, open-label trial, 190 of 226 eligible patients were included. The primary outcome was quality of life measured with the 25-item National Eye Institute Visual Function Questionnaire. Secondary outcomes were visual acuity and contrast sensitivity. The follow-up for quality of life was after 6 weeks for controls and after 3 weeks of use for E-Scoop wearers. The visual measures were repeated after 6 weeks, with optimal refractive correction, with and without E-Scoop. RESULTS: Randomization resulted in 99 E-Scoop and 86 control group patients for intention-to-treat analysis. No differential change was found between the E-Scoop and control groups on the 25-item National Eye Institute Visual Function Questionnaire using Rasch analysis (Cohen d = -0.07, P = .53). Statistically significant but small effects were found in favor of E-Scoop on binocular visual acuity (mean difference, 0.05 logMAR [2.5 letters, P < .001]) and contrast sensitivity (mean difference, 0.10 logCS [2 letters, P < .001]). CONCLUSIONS: No effect of E-Scoop on quality of life was found. E-Scoop showed effects that were statistically significant, although not clinically meaningful and within typical variability, on visual measures.

Need analysis for a new high acuity medical psychiatry unit: which patients are considered for admission?

BACKGROUND: The study aims were: to estimate the proportion of patients with an indication for admission to a new high acuity Medical Psychiatric Unit (MPU), to explore the reasons for MPU-admission according to different health disciplines, and to check for differences in patient characteristics. The results of this study are to be utilized in the proposed establishment of a high-acuity MPU in a University Medical Center. Such a unit currently does not exist at Erasmus MC. METHODS: Hospital in-patients were included if they received psychiatric consultation from the Psychiatric Consultative Service (PCS). As part of the study protocol, psychiatrists, other medical specialists, and nurses determined the need for admission to the proposed MPU. Patient groups were compared with respect to diagnoses, socio-demographic characteristics and patient routing. RESULTS: One hundred and fifty-one patients were included, 43% had an indication for MPU-admission, for the other patients PCS involvement was sufficient. There was agreement on suicide attempts as a reason for MPU-admission. For psychiatrists, the need for further diagnostic evaluation was a common reason for MPU admission, while other medical specialists more often emphasized the need for safety measures. Patients with an unplanned hospital admission had a higher chance of MPU eligibility (OR = 2.72, 95% CI 1.10-6.70). The main psychiatric diagnoses of MPU-eligible patients were organic disorders (including delirium), mood disorders, and disorders related to substance abuse. The most common diagnoses found were similar to those in previous research on MPU populations. CONCLUSION: Different medical disciplines have different views on the advantages of MPUs, while all see the need for such facilities. The proposed MPU should be able to accommodate patients directly from the Emergency Unit, and the MPU should provide specialized diagnostic care in an extra safe environment.

A prospective randomized controlled trial comparing infliximab and etanercept in patients with moderate-to-severe chronic plaque-type psoriasis: the Psoriasis Infliximab vs. Etanercept Comparison Evaluation (PIECE) study.

BACKGROUND: There are currently no independent data available comparing infliximab and etanercept for the treatment of psoriasis. OBJECTIVES: To compare these biologics without funding from pharmaceutical companies. METHODS: Overall, 50 patients were randomized to etanercept (n = 23) 50 mg subcutaneously twice weekly or infliximab (n = 25) 5 mg kg-1 intravenously at week 0, 2, 6, 14 and 22. After 24 weeks, 19 patients stopped and 22 continued treatment and were followed up to week 48. The primary outcome was ≥ 75% improvement of Psoriasis Area and Severity Index (PASI 75) at week 24. The secondary outcomes included PASI 75 at week 6 (onset of action) and week 12, Investigator's Global Assessment (IGA), Patient Global Assessment, impact on quality of life (Skindex-17 and SF-36), Treatment Satisfaction Questionnaire of Medication, duration of remission, maintenance treatment and safety. RESULTS: At week 24, PASI 75 was achieved in 72% (infliximab) vs. 35% (etanercept) (P = 0·01). The onset of action was achieved in 52% (infliximab) and 4% (etanercept). At week 12, 76% (infliximab) and 22% (etanercept) achieved PASI 75 (P < 0·001). At week 24, IGA 'clear or almost clear' was observed in 76% (infliximab) and 30% (etanercept) (P = 0·01). Skindex-17 symptom score was significantly better for infliximab. Maintenance treatment achieved PASI 75 for 67% (n = 6) infliximab vs. 50% (n = 5) etanercept, at week 48 (P = 0·65). Mild adverse events were reported in 76% (infliximab) vs. 66% (etanercept). CONCLUSIONS: Infliximab showed a rapid and significant higher level of efficacy until week 24 compared with etanercept. Long-term data showed no significant differences between both groups at week 48. Safety parameters were comparable.

Developing a decision tool to identify patients with personality disorders in need of highly specialized care.

BACKGROUND: Current guidelines recommend referral to highly specialized care for patients with severe personality disorders. However, criteria for allocation to highly specialized care are not clearly defined. The aim of the present study was to develop a decision tool that can support clinicians to identify patients with a personality disorder in need of highly specialized care. METHODS: Steps taken to develop a decision tool were a literature search, concept mapping, a meeting with experts and a validation study. RESULTS: The concept mapping method resulted in six criteria for the decision tool. The model used in concept mapping provided a good fit (stress value = 0.30) and reasonable reliability (ρ = 0.49). The bridging values were low, indicating homogeneity. The decision tool was subsequently validated by enrolling 368 patients from seven centers. A multilevel model with a Receiver Operating Characteristic Curve (ROC) was applied. In this way, an easily implementable decision tool with relatively high sensitivity (0.74) and specificity (0.69) was developed. CONCLUSIONS: A decision tool to identify patients with personality disorders for highly specialized care was developed using advanced methods to combine the input of experts with currently available scientific knowledge. The tool appeared to be able to accurately identify this group of patients. Clinicians can use this decision tool to identify patients who are in need of highly specialized treatment.

A three-component cognitive behavioural lifestyle program for preconceptional weight-loss in women with polycystic ovary syndrome (PCOS): a protocol for a randomized controlled trial.

BACKGROUND: Obesity in women with polycystic ovary syndrome (PCOS) negatively affects all clinical features, and a 5 to 10% weight loss has shown promising results on reproductive, metabolic and psychological level. Incorporating a healthy diet, increasing physical activity and changing dysfunctional thought patterns in women with PCOS are key points in losing weight. The biggest challenge in weight management programs is to achieve a reasonable and sustainable weight loss. The aim of this study is to explore whether Cognitive Behavioural Therapy (CBT) by a mental health professional, working in a multidisciplinary team with a dietician and a physical therapist (a three-component intervention), is more effective for weight loss in the long term, within 12 months. We will also explore whether mobile phone applications are effective in supporting behavioural change and sustainable weight loss. METHODS: The present study is a longitudinal randomized controlled trial (RCT) to study the effectiveness of a three-component 1-year cognitive-behavioural lifestyle intervention in overweight/obese women with PCOS. A total of 210 participants are randomly assigned to three groups: 1) CBT provided by the multidisciplinary team or; 2) CBT provided by the multidisciplinary team and Short Message Service (SMS) or; 3) usual care: encourage weight loss through publicly available services (control group). The primary aim of the 12-month intervention is to explore whether a three-component 1-year cognitive-behavioural lifestyle intervention is effective to decrease weight, when compared to usual care. Secondary outcomes include: the effect of the intervention on the PCOS phenotype, waist circumference, waist to hip ratio, ovulation rates, total testosterone, SHBG, free androgen index (FAI), AMH, hirsutism, acne, fasting glucose, blood pressure and all psychological parameters. Additionally, we assessed time to pregnancy, ongoing pregnancies, clinical pregnancies, miscarriages and birth weight. All outcome variables are measured at the start of the study, and again at 3 months, 6 months, nine months and 12 months. DISCUSSION: We expect that CBT provided by a multidisciplinary team, especially combined with SMS, is effective in developing a healthy lifestyle and achieving a long-term weight loss in women with PCOS. Losing 5- 10% body weight improves various PCOS characteristics. Consequently, we expect to show that CBT provided by a multidisciplinary team improves reproductive and metabolic outcomes, as well as quality of life, while at the same time being cost-effective. TRIAL REGISTRATION: Registered at the Netherlands National Trial Register with number NTR2450 on August 2nd, 2010.

Mental health among living kidney donors: a prospective comparison with matched controls from the general population.

The impact of living kidney donation on donors' mental health has not been sufficiently nor comprehensively studied. Earlier studies demonstrated that mental health did not change in the majority of donors, however they often lacked a suitable control group and/or had other methodological limitations. Consequently, it remains unclear whether changes in mental health found among a minority of donors reflect normal fluctuations. In this study we matched 135 donors with individuals from the general Dutch population on gender and baseline mental health and compared changes in mental health over time. Mental health was measured using the Brief Symptom Inventory and Mental Health Continuum Short Form. Primary analyses compared baseline and 6 months follow-up. Secondary analyses compared baseline and 9 (controls) or 15 months (donors) follow-up. Primary multilevel regression analyses showed that there was no change in psychological complaints (p = 0.20) and wellbeing (p = 0.10) over time and donors and controls did not differ from one another in changes in psychological complaints (p = 0.48) and wellbeing (p = 0.85). Secondary analyses also revealed no difference in changes between the groups. We concluded that changes in mental health in the short term after donation do not significantly differ from normal fluctuations found in the Dutch general population.

Home-based family intervention increases knowledge, communication and living donation rates: a randomized controlled trial.

Our aim was to develop and test an educational program to support well-informed decision making among patients and their social network regarding living donor kidney transplantation (LDKT). One hundred sixty-three patients who were unable to find a living donor were randomized to standard care or standard care plus home-based education. In the education condition, patients and members of their social network participated in home-based educational meetings and discussed renal replacement therapy options. Patients and invitees completed pre-post self-report questionnaires measuring knowledge, risk perception, communication, self-efficacy and subjective norm. LDKT activities were observed for 6 months postintervention. Patients in the experimental group showed significantly more improvements in knowledge (p < 0.001) and communication (p = 0.012) compared with the control group. The invitees showed pre-post increases in knowledge (p < 0.001), attitude toward discussing renal replacement therapies (p = 0.020), attitude toward donating a kidney (p = 0.023) and willingness to donate a kidney (p = 0.039) and a decrease in risk perception (p = 0.003). Finally, there were significantly more inquiries (29/39 vs. 13/41, p < 0.001), evaluations (25/39 vs. 7/41, p < 0.001) and actual LDKTs (17/39 vs. 4/41, p = 0.003) in the experimental group compared with the control group. Home-based family education supports well-informed decision making and promotes access to LDKT.

Thirty down, only ten to go?! Awareness and influence of a 10-year time frame in TTO.

BACKGROUND: Time trade-off (TTO) exercises typically present respondents with a limited time horizon, for example 10 years, thus implicitly considerably reducing remaining life expectancy for the average respondent. It is unclear how this affects health state valuations. AIM: The aim of the study is to investigate how awareness of the reduced life span implied by a 10-year TTO affects health state valuations, using an experimental design. METHODS: Two Web-based questionnaires (Q1 and Q2) were administered in a sample representative of the Dutch population. Both questionnaires contained three 10-year TTO exercises valuing three distinct health states, specified using the EQ-5D. Q1 used a TTO instruction not explicitly emphasizing the fact that remaining life expectancy was reduced to 10 years, while in Q2 respondents were explicitly made aware of this fact by emphasizing their implied age of death. Respondents answering Q1 were asked retrospectively whether they had been aware of their reduced life span due to the 10-year TTO. RESULTS: In total, 656 respondents completed the questionnaires (Q1: 339 and Q2: 317). The average age of the respondents was 43 years and 51 % of respondents were male. The average numbers of years traded off for the respondents of Q1 were for TTO1 0.443, TTO2 0.552, and TTO3 2.083 years. For the respondents of Q2, these averages were lower, i.e., TTO1 0.401 (p = 0.085 vs. Q1), TTO2: 0.546 (p = 0.036 vs. Q1), and TTO3: 1.467 years (p = 0.000 vs. Q1). Fifty-seven percent of respondents in Q1 confirmed that they were aware of the reduced life span. This spontaneous awareness had a limited and mixed influence on results. The generalized negative binomial regression analysis, explaining the time traded off showed that age, subjective life expectancy, and questionnaire Q2 (vs. Q1) were negatively associated with the years traded off, whereas education and worse health states in the TTO exercise had a significant positive impact on the years traded off. The probit model investigating the impact on the willingness to trade showed that age (-), education (+), subjective life expectancy (-), questionnaire Q2 versus Q1 (-), the interaction between Q2 and male gender (+), and worse health states in the TTO exercise (+) had a significant impact on the willingness to trade. CONCLUSION: These findings emphasize the importance of expected and implied life expectancy in TTOs.

Assessment of patient-reported outcomes in vitreomacular interface disorders: A systematic literature review.

Patient-reported outcome measures (PROMs) assess the impact of disease on quality of life from the patient's perspective. Our purpose was to provide an overview of current PROMs used for vitreomacular interface disorders: macular hole, epiretinal membrane, and vitreomacular traction. We review the content coverage of all identified PROMs, assess them against quality-of-life issues as identified from earlier qualitative studies, and assess their psychometric quality (measurement properties). We identified 86 studies that used a PROM and 2 qualitative studies on quality of life of patients with a vitreomacular interface disorder. Current PROMs used in vitreomacular interface disorders have a limited content coverage and unknown psychometric quality. The National Eye Institute Visual Functioning Questionnaire was used most. None of the condition-specific PROMs used patient consultation during content development, and there is only a small overlap between the content of PROMs and quality-of-life issues in qualitative studies. Reporting of psychometric quality was sparse, and mostly limited to concurrent validity and responsiveness. There is a need for properly developed and validated PROMs in vitreomacular interface disorders.

Anxiety and depressive symptoms before and after total hip and knee arthroplasty: a prospective multicentre study.

BACKGROUND: A subset of patients with total hip arthroplasty (THA) or total knee arthroplasty (TKA) has suboptimal postoperative results in terms of Patient Reported Outcomes (PROs), and psychological factors could contribute to these suboptimal results. OBJECTIVES: To examine the prevalence of anxiety and depressive symptoms in patients undergoing primary THA or TKA preoperatively and postoperatively, and the relationship between preoperative anxiety and depressive symptoms on PROs of THA and TKA. DESIGN: In this prospective study patients were measured preoperatively, and 3 and 12 months postoperatively. Patients filled in the Hospital Anxiety and Depression Scale, Knee injury and Osteoarthritis Outcome Score (KOOS) or Hip disability and Osteoarthritis Outcome Score (HOOS) and a satisfaction questionnaire. RESULTS: Data were obtained from 149 hip and 133 knee patients. The prevalence of anxiety symptoms decreased significantly from 27.9% to 10.8% 12 months postoperatively in hip patients, and from 20.3% to 14.8% in knee patients. Depressive symptoms decreased significantly from 33.6% to 12.1% 12 months postoperatively in hip patients, and from 22.7% to 11.7% in knee patients. In hip and knee patients, preoperative depressive symptoms predicted smaller changes in different HOOS or KOOS subscales and patients were less satisfied 12 months postoperatively. CONCLUSIONS: Preoperatively, the prevalence of anxiety and depressive symptoms was high. At 3 and 12 months postoperatively, the prevalence of anxiety and depressive symptoms was decreased in both hip and knee patients. However, patients with preoperative anxiety and depressive symptoms had worse PROs 3 and 12 months after THA and TKA and were less satisfied than patients without anxiety or depressive symptoms.

The effect of aortic valve replacement on quality of life in symptomatic patients with severe aortic stenosis.

BACKGROUND: Although symptomatic patients with severe aortic stenosis have a high disease burden and guidelines recommend aortic valve replacement, many are treated conservatively. This study describes to what extent quality of life is changed by aortic valve replacement relative to conservative treatment. METHODS: This observational study followed 132 symptomatic patients with severe aortic stenosis who were subjected to an SF-36v2TM Health Survey. RESULTS: At baseline 84 patients were treated conservatively, 48 were referred for aortic valve replacement. In the conservatively treated group 15 patients died during a mean follow-up of 18 months (Kaplan-Meier survival was 85 % and 72 % at one and 2 years respectively) and 22 patients crossed over to the surgical group. Of the resulting 70 patients in the surgical group 3 patients died during a mean follow-up of 11 months (survival 95 % at 1 year). Physical functioning, vitality and general health improved significantly 1 year after aortic valve replacement. In conservatively treated patients physical quality of life deteriorated over time while general health, vitality and social functioning showed a declining trend. Mental health remained stable in both groups. CONCLUSIONS: Aortic valve replacement improves physical quality of life, general health and vitality in patients with symptomatic severe aortic stenosis. Besides having a low life expectancy, conservatively treated patients experience deterioration of physical quality of life. Health surveys such as the SF-36v2TM can be valuable tools in monitoring the burden of disease for an individual patient and offer additional help in treatment decisions.

Quality of life among patients with severe aortic stenosis.

BACKGROUND: The disease burden of patients with severe aortic stenosis is not often explored, while the incidence is increasing and many patients who have an indication for aortic valve replacement are not referred for surgery. We studied the quality of life of 191 patients with severe aortic stenosis, hypothesising that symptomatic patients have a far worse quality of life than the general population, which could enforce the indication for surgery. METHODS: The SF-36v2 Health Survey was completed by 191 consecutive patients with symptomatic or asymptomatic severe aortic stenosis. RESULTS: Asymptomatic patients (n = 59) had health scores comparable with the general Dutch population but symptomatic patients (n = 132) scored significantly lower across different age categories. Physical functioning, general health and vitality were impaired, as well as social functioning and emotional well-being. There was no relation between degree of stenosis and physical or mental health scores. CONCLUSIONS: Both physical and emotional problems have a major impact on normal daily life and social functioning of symptomatic patients with severe aortic stenosis, regardless of age. If the aortic stenosis is above the 'severe' threshold, the degree of stenosis does not predict disease burden. These results encourage to reconsider a conservative approach in symptomatic patients with severe aortic stenosis. Using the SF-36v2 Health Survey together with this study, an individual patient's quality of life profile can be assessed and compared with the patient group or with the general population. This can assist in decision making for the individual patient.

Pregnancy and liver adenoma management: PALM-study.

BACKGROUND: Hepatocellular adenoma (HCA) in pregnant women requires special considerations because of the risk of hormone induced growth and spontaneous rupture, which may threaten the life of both mother and child. Due to scarcity of cases there is no evidence-based algorithm for the evaluation and management of HCA during pregnancy. Most experts advocate that women with HCA should not get pregnant or advise surgical resection before pregnancy. Whether it is justified to deny a young woman a pregnancy, as the biological behavior may be less threatening than presumed depends on the incidence of HCA growth and the subsequent clinical events during pregnancy.We aim to investigate the management and outcome of HCA during pregnancy and labor based on a prospectively acquired online database in the Netherlands. METHODS/DESIGN: The Pregnancy And Liver adenoma Management (PALM) - study is a multicentre prospective study in three cohorts of pregnant patients. In total 50 pregnant patients, ≥ 18 years of age with a radiologically and/or histologically proven diagnosis of HCA will be included in the study. Radiological diagnosis of HCA will be based on contrast enhanced MRI. Lesions at inclusion must not exceed 5 cm. The study group will be compared to a healthy control group of 63 pregnant patients and a group of 63 pregnant patients with diabetes mellitus without HCA. During their pregnancy HCA patients will be closely monitored by means of repetitive ultrasound (US) at 14, 20, 26, 32 and 38 weeks of gestation and 6 and 12 weeks postpartum. Both control groups will undergo US of the liver at 14 weeks of gestation to exclude HCA lesions in the liver. All groups will be asked to fill out quality of life related questionnaires. DISCUSSION: The study will obtain information about the behaviour of HCA during pregnancy, the clinical consequences for mother and child and the impact of having a HCA during pregnancy on the health related quality of life of these young women. As a result of this study we will propose a decision-making model for the management of HCA during pregnancy. TRIAL REGISTRATION: Dutch trial register: NTR3034.

Moving Beyond the Status Quo of Integrated Inpatient Medical and Psychiatric Care Units: The Path to Real-World Evaluation.

Integrated inpatient medical and psychiatric care units (IMPUs) are hospital wards that care for inpatients with both acute general medical and psychiatric disorders. IMPU development has stalled, and wide variation in IMPU designs may reflect the fact that IMPUs are still in an early evolutionary stage. High-quality evidence concerning the costs and effectiveness of IMPUs is sparse, because IMPUs do not lend themselves well to traditional evidence-based medicine methods. As a result, most studies of IMPUs have been only observational. Therefore, it is time for a different approach, in which goals for IMPUs are explicitly formulated and IMPU research is incorporated into evidence-based practice (EBP) instead of evidence-based medicine. EBP can be viewed as integrating best available evidence into organizational practices by using four pillars of evidence: organizational, experiential, stakeholder, and scientific. Such types of evidence require an investment in describing the field more precisely. When pragmatic reasoning, where clinical expertise and organizational needs determine IMPU designs, is replaced with EBP, researchers can more effectively perform studies that may convince health care policy makers that IMPUs represent a cost-effective way to improve patients' health and that they increase the well-being of both patients and hospital staff.

Encouraging psychological outcomes after altruistic donation to a stranger.

In a growing number of transplant centers worldwide, altruistic donors are accepted to anonymously donate a kidney to a stranger. An important hesitation to expand these transplantation programs is the fear of evoking psychological distress in the altruistic donor after donation. To what extent this fear is justified has not yet been systematically investigated. In this study, 24 altruistic donors were interviewed on average 2 years after donation. Lifetime mental health history, current psychological complaints, satisfaction with and impact of the donation on well-being, motives for donation, communication with recipient and donation experience were assessed. Altruistic donors report a considerable positive impact of donation on psychological well-being, whereas negative impact was limited. Satisfaction with donation was very high. Although a history of a psychiatric diagnosis was ascertained in almost half of the donors, psychological complaints before and after donation were comparable to national average norm scores. Motives for donation were genuine and the experience of donation generally conformed to their expectations. In conclusion, living kidney donation to a stranger does not appear to exacerbate psychological complaints. Moreover, altruistic donors report considerable satisfaction and personal benefit. The exceptional gift of altruistic donors can contribute toward solving the current organ shortage issue.

Large-scale screening and subsequent effects of migraine treatment on the work floor in the Netherlands.

In a large retail business group the ID Migraine Screening Test was sent to employees with three or more absences from work in the past year (n = 2893). Employees with positive results were invited for a neurological consultation and migraine patients were randomly assigned to: first attack 'treated as usual' and the second attack treated with 40 mg eletriptan, or reversed order. Of the 2893 employees, 799 responded (28%), 260 were positively screened for migraine (33%), 84 patients were diagnosed by a neurologist and 41 of the 75 included patients completed the protocol. Eletriptan induced pain-free response in 33.3% of the patients at 4 h compared with 0% after 'non-specific' treatment (P = 0.03). Eletriptan also significantly improved quality of life, but differences in absence from work and productivity loss could not be detected. In conclusion, in-company screening can be beneficial for undertreated employees, but implementation obstacles can reduce the effectiveness of screening.

Metamemory and memory test performance in stroke patients.

Memory Self-Efficacy (MSE) has been shown to be related to memory performance and social participation in a healthy elderly population. This relation is unclear in stroke. As about 30% of all stroke survivors report memory complaints, there is an urgent need for effective treatment strategies. Before implementing MSE as a potential target in memory training, it should be examined whether the association between MSE and memory performance demonstrated in healthy elderly people also applies in stroke patients. This study therefore explored the predictive value of MSE on two kinds of memory tests in stroke patients; adjusted and unadjusted for age, gender, education and location of stroke. In 57 stroke patients, the Metamemory in Adulthood Questionnaire (MIA), an everyday memory test (RBMT) and a more traditional memory test (AVLT) were completed. The results show that MSE significantly predicts memory test performance on both memory tests (RBMT: beta = .34; p = .01 AVLT: beta = .28; p = .04). When adjusted for gender, age, education and location of stroke, the predictive value of MSE remained significant for the AVLT (RBMT: beta = .23; p = .07; AVLT: beta = .23; p = .05). The results support the hypothesis that MSE predicts test performance in stroke patients and, by consequence, enables improving memory performance in post-acute memory rehabilitation after stroke.