Retromuscular drain output at removal does not influence adverse outcome rate in open ventral hernia repairs.

BACKGROUND: Retromuscular drains are commonly placed during retromuscular hernia repair (RHR) to decrease postoperative wound complications and help mesh in-growth. Drains are traditionally removed when output is low but the relationship between drain output at the time of removal and postoperative complications has yet to be delineated. This study aimed to investigate outcomes of RHR patients with drain removal at either high or low output volume. METHODS: An institutional review board-approved retrospective chart review evaluated adult patients undergoing open RHR with retromuscular drain placement between 2013 and 2022 at a single academic medical center. Patients were stratified into low output drainage (LOD, < 50 mL/day) or high output drainage (HOD, ≥ 50 mL/day) groups based on volume on the day of drain removal. RESULTS: We identified 336 patients meeting inclusion criteria: 58% LOD (n = 195) and 42% HOD (n = 141). Demographics and risk factors pertaining to hernia complexity were similar between cohorts. Low-drain output at the time of removal was associated with a significantly longer drain duration (6.3 ± 4.5 vs. 4.4 ± 1.6 days, p < 0.001) and postoperative hospital stay (5.9 ± 3.6 vs. 4.8 ± 2.8 days, p < 0.001). With a 97% 30-day follow-up, incidence of surgical site occurrence (SSO) was not statistically different between groups (29.2% LOD, 26.2% HOD, p = 0.63). Surgical site infection and SSO requiring procedural intervention was also not statistically significant between cohort. At 1-year follow-up, hernia recurrence rates were the same between groups (4.2% LOD, 1.4% HOD, p = 0.25). CONCLUSION: Following open ventral hernia repair with retromuscular mesh placement, the rate of postoperative wound complications was not statistically different based on volume of drain output day of removal. These results suggest that removing drains earlier despite higher output is safe and has no effect on short- or long-term hernia outcomes.

How mood is affected by environment and upsetting events: The moderating role of psychological flexibility.

OBJECTIVE: Patients suffering from psychological disorders report decreased quality of life and low mood. The relationship of these symptoms to daily upsetting events or environments, and in the context of active coping mechanisms is poorly understood. The present study thus investigates the association between mood, psychological flexibility, upsetting events, and environment in the daily life of outpatients. METHOD: We investigated 80 outpatients at the beginning of treatment, using event sampling methodology (ESM). Patients' mood, occurrence of upsetting events, current environment, and psychological flexibility were sampled six times per day during a one-week intensive longitudinal examination. Data were analyzed using linear mixed models (LMMs). RESULTS: Participants reported worse mood the more upsetting events they experienced. Further, participants reported better mood when in private environments (e.g., with friends), and worse mood when at the hospital, compared to being at home. Higher levels of psychological flexibility, however, were associated with better mood, irrespective of the occurrence of upsetting events or current environment. CONCLUSION: Results suggest that mood is positively associated with psychological flexibility, not despite, but especially during the dynamic and context-specific challenges of daily life. Psychological flexibility may thus potentially act as a buffer against distress-provoking situations as patients go about their daily lives. TRIAL REGISTRATION: ISRCTN.org identifier: ISRCTN11209732.

Psychotherapy for Chronic In- and Outpatients with Common Mental Disorders: The "Choose Change" Effectiveness Trial.

INTRODUCTION: Treatment non-response occurs regularly, but psychotherapy is seldom examined for such patients. Existing studies targeted single diagnoses, were relatively small, and paid little attention to treatment under real-world conditions. OBJECTIVE: The Choose Change trial tested whether psychotherapy was effective in treating chronic patients with treatment non-response in a transdiagnostic sample of common mental disorders across two variants of treatment delivery (inpatient and outpatient). METHODS: The controlled nonrandomized effectiveness trial was conducted between May 2016 and May 2021. The study took place in two psychiatric clinics with N = 200 patients (n = 108 inpatients and n = 92 outpatients). Treatment variants were integrated inpatient care versus outpatient care based on acceptance and commitment therapy (ACT) for approximately 12 weeks. Therapists delivered individualized and non-manualized ACT. Main outcome measures were symptoms (Brief Symptom Checklist [BSCL]); well-being (Mental Health Continuum-Short Form [MHC-SF]), and functioning (WHO Disability Assessment Schedule [WHO-DAS]). RESULTS: Both inpatients and outpatients showed decreases in symptomatology (i.e., BSCL: d = 0.68) and increases in well-being and functioning (MHC-SF: d = 0.60 and WHO-DAS: d = 0.70), with more improvement in the inpatients during treatment. Both groups maintained gains 1 year following treatment, and the groups did not significantly differ from each other at this timepoint. Psychological flexibility moderated impact of stress on outcomes. CONCLUSIONS: Psychotherapy as practiced under routine conditions is effective for a sample of patients with common mental disorders, a long history of treatment experience and burden of disease, in both inpatient and outpatient settings. TRIAL REGISTRATION: This study was registered in the ISRCTN registry on May 20, 2016, with the registration number ISRCTN11209732.

[Implementation of a Pilot Project Supporting Parents Suffering from Cancer with Underage Children]. / Implementierung eines Modellprojektes zur phasenübergreifenden Unterstützung von krebskranken Eltern mit minderjährigen Kindern.

OBJECTIVE: Families with one parent suffering from cancer are exposed to extraordinary emotional and organizational burdens, affecting underaged children. To help coordinated access to social and logistic support options and thus reduce the stress on family members, the project Brückenschlag was founded. The aim of this paper was to evaluate the implementation of this pilot project following the healthcare utilization model by Andersen. METHODS: A cross-sectional observational study was conducted using a mixed-method approach. Semi-structured written expert surveys (n=10) and secondary analysis of routine data of the care model (n=171 families) were combined. RESULTS: Quantitative secondary analysis: The participating families had 1-7 children (median (m) 2, range (s) 6). In 66% of the cases, the mother was affected by cancer, in 20% the diseased parent was in a single parent household. The communication structure in these families was rated "limited" to "rather open". Of the total of 171 contacts (study period 9/14 to 11/17), 133 families made use of Brückenschlag; 59.2% of the contacts were made by psycho-oncologists and the social services department of the hospital. If the contact was initiated by the patients themselves or by psycho-oncologists, a guidance was established significantly more frequently (significance of chi-squared test 0.047). Qualitative analysis: There was a lack of awareness and coordination of existing support services and a lack of family resources to use existing support offers. Both the desired and the established support fell primarily in the area of organizational support. Brückenschlag improved networking and took on a navigating function for the families. CONCLUSION: The data collected indicate that in families, matching the German average in their socio-demographic characteristics, a great need for organizational support develops as soon as one parent becomes sick with cancer. The model project Brückenschlag creates an access to support services for families with one parent suffering from cancer.

["It's Left a Bitter Taste" Psychotherapists' Perspectives on the Abolition of the German Assessment Procedure for Outpatient Psychotherapy]. / "Es hat so einen etwas bitteren Beigeschmack" Die Abschaffung des Antrags- und Gutachterverfahrens aus Sicht von Psychotherapeut*innen in der ambulanten Versorgung.

BACKGROUND AND RESEARCH QUESTION: In 2019, the abolition and replacement of the present German assessment procedure for outpatient psychotherapy was resolved and adopted into law. This study examined what psychotherapists think about the new plan. METHODS: We conducted semi-guided interviews with psychotherapists about their experience and opinion of the current psychotherapeutic care situation in Germany. Statements about the assessment procedure were evaluated using qualitative text analyses. We compared the psychotherapists' opinion on the assessment procedure with the psychotherapeutic approach as well as the age group. RESULTS: Of 41 psychotherapists 27 reported their thoughts about the assessment procedure. The following themes could be drawn from their statements: Appreciation as well as criticism of quality control of the procedure, worries about a future loss of economic and treatment certainty, perception that the assessment procedure questions one's competence, disapproval of the low remuneration of the reports, the connection between individual attitudes towards the assessment report and conscientiousness in writing the reports, and the lack of transparency of the legislative initiative. Psychodynamic psychotherapists wanted to keep the assessment procedure slightly more often compared to behavioural psychotherapists; child and youth psychotherapists wanted to keep it more often than psychotherapists for adults. DISCUSSION: Psychotherapists perceive the reform of the assessment procedure as a process with a substantial impact on their current clinical practice as well as their psychotherapeutical identity. To improve the quality and acceptance of the future quality assurance procedure, psychotherapists should be an active part of the development process.

A Randomized Trial Comparing the Specific Carbohydrate Diet to a Mediterranean Diet in Adults With Crohn's Disease.

BACKGROUND & AIMS: This study compared the effectiveness of the Specific Carbohydrate Diet (SCD) to the Mediterranean diet (MD) as treatment for Crohn's disease (CD) with mild to moderate symptoms. METHODS: Adult patients with CD and with mild-to-moderate symptoms were randomly assigned 1:1 to consume the MD or SCD for 12 weeks. For the first 6 weeks, participants received prepared meals and snacks according to their assigned diet. After 6 weeks, participants were instructed to follow the diet independently. The primary outcome was symptomatic remission at week 6. Key secondary outcomes at week 6 included fecal calprotectin (FC) response (FC <250 µg/g and reduction by >50% among those with baseline FC >250 µg/g) and C-reactive protein (CRP) response (high-sensitivity CRP <5 mg/L and >50% reduction from baseline among those with high-sensitivity CRP >5 mg/L). RESULTS: The study randomized 194 patients, and 191 were included in the efficacy analyses. The percentage of participants who achieved symptomatic remission at week 6 was not superior with the SCD (SCD, 46.5%; MD, 43.5%; P = .77). FC response was achieved in 8 of 23 participants (34.8%) with the SCD and in 4 of 13 participants (30.8%) with the MD (P = .83). CRP response was achieved in 2 of 37 participants (5.4%) with the SCD and in 1 of 28 participants (3.6%) with the MD (P = .68). CONCLUSIONS: The SCD was not superior to the MD to achieve symptomatic remission, FC response, and CRP response. CRP response was uncommon. Given these results, the greater ease of following the MD and other health benefits associated with the MD, the MD may be preferred to the SCD for most patients with CD with mild to moderate symptoms. ClinicalTrials.gov Identifier: NCT03058679.

Participative development and evaluation of a communication skills-training program for oncologists-patient perspectives on training content and teaching methods.

BACKGROUND: Using the 6-step approach to curriculum development for medical education, we developed a communication skills training (CST) curriculum for oncology and evaluated this curriculum from the perspective of cancer patients. METHODS: We conducted a qualitative interview study with cancer patients, collecting data using semi-structured face-to-face or telephone interviews with a short standardized survey. We fully transcribed the audiotaped interviews and conducted the content analysis using MAXQDA 2020. We analyzed the quantitative sociodemographic data descriptively. RESULTS: A total of 22 cancer patients participated, having a mean age of 60.6 (SD, 13.2) years and being predominantly female (55%). The patients believed that the CST curriculum addressed important aspects of patient-centered communication in cancer care. They emphasized the importance of physicians acquiring communication skills to establish a trusting relationship between doctor and patient, show empathy, inform patients, and involve them in treatment decisions. The patients had some doubts concerning the usefulness of strict protocols or checklists (e.g., they feared that protocol adherence might disturb the conversation flow). DISCUSSION: Although it was a challenge for some participants to take the perspective of a trainer and comment on the CST content and teaching methods, the patients provided a valuable perspective that can help overcome blind spots in CST concepts.

How Response Styles Moderate the Relationship between Daily Stress and Social Interactions in Depression, Social Phobia, and Controls.

INTRODUCTION: Stress and social isolation are potent predictors of negative health outcomes and are impacted in mood and anxiety disorders. Difficulties in social interactions have been particularly noted in people diagnosed with major depression disorder (MDD) and social phobia (SP). It remains poorly understood, however, how these variables interact on a moment-to-moment basis and which variables moderate this relationship. Psychological flexibility, or the ability to be open to experiences while maintaining engagement in valued activities, may help moderate the relationship between stress and social interaction. OBJECTIVE: This study examined these variables in participants diagnosed with MDD and SP and compared them to a control group. METHODS: Participants were diagnosed with a mental disorder (n = 118 MDD; n = 47 SP) or were in the control group consisting of participants without MDD or SP (n = 119). Using the event sampling methodology (ESM), participants were queried six times per day for 7 days about stress, social interactions, and emotional response (rigid vs. flexible). RESULTS: Higher current stress levels were related to more social interactions. This relationship was even stronger in situations when response flexibility was increased, especially in the clinical groups. CONCLUSIONS: Data suggest that a healthy psychological process (flexible emotional responding) buffers the relationship between stress and social interactions. We discuss how these variables interact and whether these patterns may paradoxically contribute to the maintenance of psychopathology.

The spatiotemporal movement of patients in and out of a psychiatric hospital: an observational GPS study.

BACKGROUND: Movement is a basic component of health. Little is known about the spatiotemporal movement of patients with mental disorders. The aim of this study was to determine how spatiotemporal movement of patients related to their symptoms and wellbeing. METHOD: A total of 106 patients (inpatients (n = 69) and outpatients (n = 37)) treated for a wide range of mental disorders (transdiagnostic sample) carried a GPS-enabled smartphone for one week at the beginning of treatment. Algorithms were applied to establish spatiotemporal clusters and subsequently related to known characteristics of these groups (i.e., at the hospital, at home). Symptomatology, Wellbeing, and Psychological flexibility were also assessed. RESULTS: Spatiotemporal patterns of inpatients and outpatients showed differences consistent with predictions (e.g., outpatients showed higher active areas). These patterns were largely unassociated with symptoms (except for agoraphobic symptoms). Greater movement and variety of movement were more predictive of wellbeing, however, in both inpatients and outpatients. CONCLUSION: Measuring spatiotemporal patterns is feasible, predictive of wellbeing, and may be a marker of patient functioning. Ethical issues of collecting GPS data are discussed.

Walking onset: a poor predictor for motor and cognitive skills in healthy preschool children.

BACKGROUND: The onset of walking is thought to be an indicator of early development. However, evidence is mixed and clear data on this relationship at preschool age is missing. The study aimed at investigating if walking onset and motor and cognitive development in preschool children are related. METHODS: A total of 555 children (mean age 3.86 years) of the Swiss Preschoolers' Health Study SPLASHY were tested twice at their childcare center (at baseline and one year later). Motor skills and cognitive skills were assessed by standardized testing procedures and parents were asked to provide information on walking onset of their child. RESULTS: Late onset of walking was related to poorer motor skills (fine motor skills, static and dynamic balance (all p < 0.003)) and poorer cognitive skills (selective attention and visual perception (p = 0.02; p = 0.001) in late preschool age. CONCLUSIONS: For children with late walking onset a close monitoring of their development in the regular pediatric child health visits may be reasonable. TRIAL REGISTRATION: ISRCTN41045021 .

Impact of Leptin on Periodontal Ligament Fibroblasts during Mechanical Strain.

Orthodontic treatment to correct dental malocclusions leads to the formation of pressure zones in the periodontal ligament resulting in a sterile inflammatory reaction, which is mediated by periodontal ligament fibroblasts (PDLF). Leptin levels are elevated in obesity and chronic inflammatory responses. In view of the increasing number of orthodontic patients with these conditions, insights into effects on orthodontic treatment are of distinct clinical relevance. A possible influence of leptin on the expression profile of PDLF during simulated orthodontic mechanical strain, however, has not yet been investigated. In this study, PDLF were exposed to mechanical strain with or without different leptin concentrations. The gene and protein expression of proinflammatory and bone-remodelling factors were analysed with RT-qPCR, Western-blot and ELISA. The functional analysis of PDLF-induced osteoclastogenesis was analysed by TRAP (tartrate-resistant acid phosphatase) staining in coculture with human macrophages. Pressure-induced increase of proinflammatory factors was additionally elevated with leptin treatment. PDLF significantly increased RANKL (receptor activator of NF-kB ligand) expression after compression, while osteoprotegerin was downregulated. An additional leptin effect was demonstrated for RANKL as well as for subsequent osteoclastogenesis in coculture after TRAP staining. Our results suggest that increased leptin concentrations, as present in obese patients, may influence orthodontic tooth movement. In particular, the increased expression of proinflammatory factors and RANKL as well as increased osteoclastogenesis can be assumed to accelerate bone resorption and thus the velocity of orthodontic tooth movement in the orthodontic treatment of obese patients.

BED-online: Acceptance and efficacy of an internet-based treatment for binge-eating disorder: A randomized clinical trial including waitlist conditions.

OBJECTIVE: Internet-based guided self-help (GSH) programs increase accessibility and utilization of evidence-based treatments in binge-eating disorder (BED). We evaluated acceptance and short as well as long-term efficacy of our 8-session internet-based GSH program in a randomized clinical trial with an immediate treatment group, and two waitlist control groups, which differed with respect to whether patients received positive expectation induction during waiting or not. METHOD: Sixty-three patients (87% female, mean age 37.2 years) followed the eight-session guided cognitive-behavioural internet-based program and three booster sessions in a randomized clinical trial design including an immediate treatment and two waitlist control conditions. Outcomes were treatment acceptance, number of weekly binge-eating episodes, eating disorder pathology, depressiveness, and level of psychosocial functioning. RESULTS: Treatment satisfaction was high, even though 27% of all patients dropped out during the active treatment and 9.5% during the follow-up period of 6 months. The treatment, in contrast to the waiting conditions, led to a significant reduction of weekly binge-eating episodes from 3.4 to 1.7 with no apparent rebound effect during follow-up. All other outcomes improved as well during active treatment. Email-based positive expectation induction during waiting period prior to the treatment did not have an additional beneficial effect on the temporal course and thus treatment success, of binge episodes in this study. CONCLUSION: This short internet-based program was clearly accepted and highly effective regarding core features of BED. Dropout rates were higher in the active and lower in the follow-up period. Positive expectations did not have an impact on treatment effects.

Vulnerable narcissism as beneficial factor for the therapeutic alliance in borderline personality disorder.

Evidence suggests that narcissism and borderline personality disorder are associated with each other. This naturalistic study investigated the predictive value of grandiose and vulnerable narcissism on the development of the therapeutic alliance in short-term psychodynamic treatment across 12 weeks. The sample consisted of 99 patients with borderline personality disorder. Narcissism was assessed with the Pathological Narcissism Inventory at treatment onset. The therapeutic alliance was rated with the Scale to Assess Therapeutic Relationships by both patient and therapist at four time points during treatment. Results showed a significant predictive value of vulnerable narcissism on the therapeutic alliance, revealing a more beneficial progression for patients with higher vulnerable narcissism. Grandiose narcissism had no predictive value on the therapeutic alliance. The study strengthens the clinical utility of the concept of vulnerable narcissism towards the evaluation of treatment processes in borderline personality disorder.

Impulsiveness in borderline personality disorder predicts the long-term outcome of a psychodynamic treatment programme.

Despite the preponderance of treatment outcome predictors in patients with borderline personality disorder (BPD), the predictive value of measures of impulsiveness is inconclusive. This naturalistic study consecutively included hospitalized patients with BPD (N = 99) who underwent a standardized and structured 12-week inpatient treatment programme, which integrated cognitive-behavioural and psychodynamic elements. The Brief Symptom Checklist (BSCL) was applied as outcome measure over four time points: pretreatment, posttreatment, first follow-up at 6 to 8 weeks and second follow-up at 1 year after discharge. Impulsiveness was measured using the Barratt Impulsiveness Scale (BIS) at the pretreatment time point. The BSCL significantly decreased between pretreatment and posttreatment, followed by an increase after posttreatment without reaching pretreatment extent. The temporal course of the BSCL significantly varied with pretreatment BIS in that patients with higher impulsiveness revealed a stronger re-increase of symptom severity from posttreatment to end of follow-up than those with lower impulsiveness. The least impulsive patients thereby showed no rebound effect. The robustness of the results was examined by cross-validation. The results indicate that irrespective of the level of impulsiveness, patients with BPD profit from a structured inpatient treatment. However, long-term treatment success was impaired in patients with high level of impulsiveness at pretreatment. Thus, self-ratings of impulsiveness in BPD patients can be utilized for treatment planning. After discontinuation of interventions, relapse prevention should be implemented early in high impulsive patients as symptoms recrudesce in the course after discharge.

[Psycho-oncological care in private practices: a survey among psychotherapists with and without licence for reimbursement with public health insurance]. / Psychoonkologische Versorgung bei niedergelassenen Psychotherapeuten: eine Befragung von Therapeuten mit und ohne Kassensitz.

Psycho-oncological care in private practices: a survey among psychotherapists with and without licence for reimbursement with public health insurance Objective: This study examined how certified psychotherapist working in an outpatient setting organise their practice to be able to treat cancer patients and what specific problems they encounter. We differentiated between therapists with and without licence. Methods: Out of the list of psychotherapists held by the German Cancer Information Service, a random sample of practices was selected. They received a mailed questionnaire. Per practice, only one therapist was selected. The questionnaire was developed by a group of psychotherapists from two psycho-oncological associations in Germany. Practices with and without licence were compared using chi-square, ranksum tests and multivariate regression analyses (adjusting for professional qualification and school of therapy). Results: Of 257 contacted practices, 160 therapists participated, and 144 were certified and could be included (62 without and 82 with licence). Waiting times for a first consultation for cancer patients were on average 10 days in practices of therapists without licence and 18 days with licence (p < 0.01). Crisis intervention within 3 days was possible for 62 % of the therapists without and for 44 % with licence (p = 0.08). There was no evidence for differences in what treatment options both types of therapists offered. Both groups reported that more than half of the cancer patients (60 % without and 58 % with licence) had to cancel their appointments at least once every 3 months, and 64 % of the therapists did not ask a fee for that. Financing of the treatment happened most frequently via compensation from health insurance companies via their licence in therapists with licence and via private payment or so called "Kostenerstattung" in therapists without licence. Discussion: In psycho-oncological practices, waiting times for a first consultation for cancer patients are on average 4 weeks shorter than in general, especially short in practices without licence. Cancellation of appointments by patients are relatively frequent in both groups of therapists, which bears financial risks for them. Special methods of compensation for services such as selective contracts are infrequently used..

The effect of anticipatory stress and openness and engagement on subsequently perceived sleep quality-An Experience Sampling Method study.

High stress levels can influence sleep quality negatively. If this also applies to anticipatory stress is poorly documented, however. Across insomnia severity levels, this study examined participants' evening levels of (a) anticipatory stress and (b) their skills hypothesized to downregulate the impact of stress, namely openness to internal experiences and continuous engagement in meaningful activities (openness and engagement) and their association with the quality of the subsequent night's sleep. The moderating role of insomnia severity was also tested. We used a quasi-experimental longitudinal design with Experience Sampling Method using smartphones over the course of 1 week (3,976 assessments; 93.2% of prompted queries). Participants recorded their sleep quality, anticipatory stress, and openness and engagement within their daily context. Participants included in the study were diagnosed with major depressive disorder (n = 118), social phobia (n = 47) or belonged to the control group (n = 119). Both anticipatory stress and openness and engagement predicted subsequent sleep quality. Diagnostic group was associated with overall sleep quality, but did not interact with the predictors. These findings were invariant across levels of self-reported insomnia severity. Furthermore, openness and engagement and anticipatory stress did not interact in their effect on sleep quality. The results suggest that both stress reduction and increased openness and engagement are associated with improved subjective sleep quality on a day to day basis, regardless of insomnia severity. Targeting these variables may help improve sleep quality. Future research should disentangle the effects of openness and engagement on anticipatory stress.

Specific traumatic events elevate the risk of a suicide attempt in a 10-year longitudinal community study on adolescents and young adults.

Traumatic events (TEs) have been associated with suicide attempts (SAs). However, the empirical status of some TEs is inconclusive. This also concerns community adolescents and young adults, known to be a high-risk group for SAs. We examined associations between (a) a range of prior TEs (physical attack, rape/sexual abuse, serious accident, and witnessing somebody else experiencing a TE) and a subsequent SA, and (b) the number of prior TEs and an SA, and (c) we estimated attributable proportions of SAs, in relation to each TE. Over a 10-year period, the Early Developmental Stages of Psychopathology (EDSP) study prospectively assessed community members, aged 14-24 years at baseline. Starting with 3021 subjects, each individual was assessed up to four times. Assessment was based on the Munich-Composite International Diagnostic Interview. Temporal associations were estimated using the Cox model with time-dependent covariates. Attributable proportions were based on the results of the Cox models. All four TEs elevated the risk for a subsequent SA, adjusting for confounders. Highest risk was found for the combined TE rape/sexual abuse. Results showed that 56-90% of SAs could be attributed to TEs in the exposed group; on the population level, attributable proportions ranged between 6.9% and 23.5%. Different TEs have been shown to elevate the risk of an SA in a young community sample. Our results suggest that both health professionals and health policy decision-makers consider specific TEs and the number of prior TEs as risk factors for SAs.

Design and development of a disease-specific quality of life tool for patients with aplastic anaemia and/or paroxysmal nocturnal haemoglobinuria (QLQ-AA/PNH)-a report on phase III.

To date, instruments to measure quality of life (QoL) specifically for patients with acquired aplastic anaemia (AA) and paroxysmal nocturnal haemoglobinuria (PNH) are lacking altogether. As a consequence, this issue is either underevaluated or alternatively, instruments originally designed for cancer patients are being used. We therefore started to systematically develop a AA/PNH-specific QoL (QLQ-AA/PNH) instrument in these ultra-rare diseases according to European Organisation for Research and Treatment of Cancer (EORTC) guidelines. While phases I and II of the process have previously been published, we now report on the resulting instrument (phase III of this process). As part of the phase III of the evaluation process, we approached patients through physicians, patient support groups, and patient conferences. After participants completed the preliminary questionnaire and reported socio-demographic data, they were interviewed in person or via phone with a debriefing interview to find out whether the items were relevant, easy to understand, and acceptable to patients and whether there was anything missing in the questionnaire. We hypothesised what items could be combined into a scale and calculated Cronbach's alpha to define its preliminary internal consistency. After definition of a priori criteria to keep or delete items, a group of six experts met in person, discussed the results, and decided on in- or exclusion. A total of 48 patients were enrolled, 21 of those suffered from AA (44%), 13 from PNH (27%), and 14 from AA/PNH syndrome (29%). The median time to complete the 69 items was 10 min (range 5-20), mean time 11 min. The compliance criterion (> 95% completion) was fulfilled by 57 items. Twenty-three items were mentioned as especially relevant by ≥ 2% of the patients. Cronbach's alpha of the hypothesised scales ranged from 0.63 (social support) to 0.92 (fear of progression and illness intrusiveness). Finally, 47 items were kept; 16 were deleted, and 5 were changed, while 1 item expanded. This resulted in 54 items in total. As no issues were mentioned to lacking by a minimum of five patients, no items were added to the questionnaire. After completion, the AA/PNH-QoL tool (QLQ-AA/PNH) was translated according to EORTC guidelines into English, French, and Italian. For patients with PNH and AA until now, the standard assessment for QoL was to use the EORTC Quality of Life Questionnaire (QLQ-C30) or the Functional Assessment of Chronic Illness Therapy Fatigue Instrument (FACIT-Fatigue). We herewith present a new instrument aimed to be better tailored to the needs of PNH and AA patients. The anticipated fourth development phase will be performed for psychometric validation; however, we already explored the internal consistency of the hypothesised scales and found the results to be very good. Hence, the new QLQ-AA/PNH with 54 items can be used in trials and clinical studies from now on, according to EORTC strategy even if the scoring algorithm at this point is preliminary and the QLQ-AA/PNH might change slightly after phase IV. This is important, as there are no other disease-specific instruments available for AA/PNH patients right now.

"Choose change": design and methods of an acceptance and commitment therapy effectiveness trial for transdiagnostic treatment-resistant patients.

BACKGROUND: Acceptance and Commitment Therapy (ACT) has been successfully established in hundreds of efficacy trials. It is less understood, however, how ACT works in real-world settings. Furthermore, little is known about how contextual variables such as treatment setting (inpatient vs. outpatient), social network and environment of the patient impact outcome. METHODS: This paper describes the methods of the Choose Change study that compares transdiagnostic inpatients (n = 85) and outpatients (n = 85) with varying degrees of treatment experience and treatment success (i.e., no previous treatment vs. previous remission vs. treatment-resistant). Patients received ACT during an intensive treatment phase lasting approximately twelve treatment sessions, and were accompanied up to twelve months following intensive treatment. Main outcomes include symptoms, functioning, and well-being. Multiple levels of data are investigated, including treatment context, weekly assessments, a behavioral approach test, multiple follow-up phases, and ambulatory assessment using Event Sampling Methodology, to examine patients' daily context. DISCUSSION: We aim to investigate antecedents, consequences, and inherent processes that contribute to the maintenance or fluctuations of psychological disorders and the efficacy of ACT treatment. Furthermore, this study intends to increase understanding of how accurately participants can report on their own experiences, in order to expand our knowledge of how to probe for such information in the future. The results of Choose Change will provide basic clinical theory and clinical care with important and meaningful insights into the effectiveness of ACT, trans diagnostically, in in- and outpatients, and in a naturalistic setting. TRIAL REGISTRATION: This study was retrospectively registered in the ISRCTN Registry (registration number ISRCTN11209732 ) on May 20th 2016.

Outcome comparison of integrated psycho-oncological care versus unstructured care-Results of a non-randomised open-label two-arm trial.

OBJECTIVE: To compare patients' experiences with a systematic, integrated psycho-oncological care (IC) model to experiences with "care as usual" (CAU). METHODS: To improve patients' knowledge about psychosocial support options and to facilitate use, an IC model was developed by psycho-oncologists and a health insurance company and implemented in one German cancer care facility. Using a parallel, non-randomised design, these patients' experiences were compared to CAU patients. In 2015, both patient groups received questionnaires 6-12 months post-inpatient treatment. Main outcomes were awareness, use and opinion of psycho-oncological care (PC) and anxiety level (Generalized Anxiety Disorder Scale (GAD-7)). RESULTS: 228 patients (IC = 90; CAU = 138) participated (response rate 24%). More IC patients felt adequately informed about PC (63% vs. 46%, ORadj : 2.5 (CI: 1.3-4.8); p = 0.008). More IC patients recalled being offered various support options and had had at least one PC discussion (44% vs. 33%, ORadj of IC patient saying "yes" instead of "No, didn't want to" compared to a CAU patient: 0.4 (CI: 0.2-0.8); p = 0.01). More IC patients rated their care as good/excellent (49% vs. 38%, ORadj : 1.8 (CI: 0.7-4.1; p = 0.2)). Anxiety levels were similar (GAD-7 score>=10: IC 34% vs. CAU 28%; p = 0.4). CONCLUSION: Structured psycho-oncological care had some positive results on the outcomes, but anxiety levels did not differ.