Pediatric Patients with Eosinophilic Esophagitis and Their Parents Identify Symptoms as the Most Important Treatment Outcome.

INTRODUCTION: Given the lack of data, we aimed to explore which therapeutic endpoints pediatric patients with eosinophilic esophagitis (EoE) and their parents consider to be relevant. METHODS: We created an educational brochure on EoE and a questionnaire, both of which were content-validated by pediatric patients and parents. Validated documents were sent to 112 patients and parents. They ranked the importance (5 levels) of short (during next 3 months) and long-term (≥1 year) treatment effect on symptoms, quality of life, endoscopic inflammation, stricture formation, histological inflammation, and fibrosis. RESULTS: A total of 45 parents and 30 pediatric patients ≥11 years completed the questionnaires. Pediatric patients identified improvement in the following domains as most important in the short- and long-term, respectively: symptoms (73% vs. 77%), QoL (53% vs. 57%), histologic inflammation (47% vs. 50%), histologic fibrosis (40% vs. 33%), endoscopic inflammation (47% vs. 40%), and strictures (33% vs. 40%). Parents of children ≥11 years old classified improvement in the following domains as most important in the short- and long-term, respectively: symptoms (70% vs. 83%), QoL (63% vs. 80%), histologic inflammation (67% vs. 77%), histologic fibrosis (47% vs. 63%), endoscopic inflammation (77% vs. 80%), and strictures (40% vs. 53%). Agreement between caregiver and children on the short-term importance of treatment outcomes was as follows: symptoms (77%), QoL (40%), histologic inflammation and fibrosis (47% and 43%), endoscopic inflammation and strictures (50% and 40%). CONCLUSION: Pediatric patients and parents attributed most importance to improvement in symptoms and QoL. Agreement between parents and patients regarding therapy goals is limited.

Regional differences in physicians' behavior and factors influencing the intensity of PCSK9 inhibitor therapy with alirocumab: a subanalysis of the ODYSSEY APPRISE study.

Background: Despite better accessibility of the effective lipid-lowering therapies, only about 20% of patients at very high cardiovascular risk achieve the low-density lipoprotein cholesterol (LDL-C) goals. There is a large disparity between European countries with worse results observed for the Central and Eastern Europe (CEE) patients. One of the main reasons for this ineffectiveness is therapeutic inertia related to the limited access to appropriate therapy and suitable dosage intensity. Thus, we aimed to compare the differences in physicians' therapeutic decisions on alirocumab dose selection, and factors affecting these in CEE countries vs. other countries included in the ODYSSEY APPRISE study. Methods: ODYSSEY APPRISE was a prospective, single-arm, phase 3b open-label (≥12 weeks to ≤30 months) study with alirocumab. Patients received 75 or 150 mg of alirocumab every 2 weeks, with dose adjustment during the study based on physician's judgment. The CEE group in the study included Czechia, Greece, Hungary, Poland, Romania, Slovakia, and Slovenia, which we compared with the other nine European countries (Austria, Belgium, Denmark, Finland, France, Germany, Italy, Spain, and Switzerland) plus Canada. Results: A total of 921 patients on alirocumab were involved [modified intention-to-treat (mITT) analysis], including 114 (12.4%) subjects from CEE countries. Therapy in CEE vs. other countries was numerically more frequently started with lower alirocumab dose (75 mg) at the first visit (74.6 vs. 68%, p = 0.16). Since week 36, the higher dose was predominantly used in CEE patients (150 mg dose in 51.6% patients), which was maintained by the end of the study. Altogether, alirocumab dose was significantly more often increased by CEE physicians (54.1 vs. 39.9%, p = 0.013). Therefore, more patients achieved LDL-C goal at the end of the study (<55 mg/dl/1.4 mmol/L and 50% reduction of LDL-C: 32.5% vs. 28.8%). The only factor significantly influencing the decision on dose of alirocumab was LDL-C level for both countries' groups (CEE: 199.2 vs. 175.3 mg/dl; p = 0.019; other: 205.9 vs. 171.6 mg/dl; p < 0.001, for 150 and 75 mg of alirocumab, respectively) which was also confirmed in multivariable analysis (OR = 1.10; 95% CI: 1.07-1.13). Conclusions: Despite larger unmet needs and regional disparities in LDL-C targets achievement in CEE countries, more physicians in this region tend to use the higher dose of alirocumab, they are more prone to increase the dose, which is associated with a higher proportion of patients reaching LDL-C goals. The only factor that significantly influences decision whether to increase or decrease the dose of alirocumab is LDL-C level.

The Therapeutic Goals Set by University Students in an Anonymous Web-Based Therapy and Support Setting.

The interest in student mental health and wellbeing has increased in recent years. Additionally, there is a rising volume of students seeking support. Numerous online resources have been developed to meet this need, including anonymous web-based therapy. To date, there has been little focus upon how students may utilise such a service, and this study examines routine evaluation data (solicited from a Goal-based Outcome Measure) from a United Kingdom based service provider. Over the course of one academic year (2018-2019), 211 students articulated therapeutic goals within Kooth Student, a web-based therapy and support service for individuals in higher education. These goals were examined for key trends. The students identified a total of 625 goals to work on in therapy, with individuals setting an average of three goals each. The most common goals focused upon obtaining additional support within the service and exploring their emotions. The results suggested that female students were more likely to move towards achieving their goals, with goals that did move shifting an average of 7.74 on a 10-point scale. Practical goals that focused upon getting more help, both inside and outside the service, were most likely to be achieved. In contrast, self-help/self-care goals were less likely to be achieved. These results provide a helpful insight into how students made use of therapy and highlight the importance of the interaction that web-based services have with other provision (web-based and in-person). They also demonstrate the challenge of capturing meaningful outcome data in anonymous services.

Treatment of Metastatic Colorectal Carcinoma with Bevacizumab in First-Line and beyond First Progression: The KORALLE Non-Interventional Cohort Study.

INTRODUCTION: The non-interventional study (NIS) KORALLE evaluated the effectiveness and safety of bevacizumab in patients with metastatic colorectal carcinoma (mCRC) treated with bevacizumab in combination with fluoropyrimidine-based chemotherapy in the first-line setting and beyond first progression in routine clinical practice. METHODS: This prospective, multicenter NIS observed adult patients with mCRC who started first-line bevacizumab therapy. The planned maximum duration of observation per patient was 21 months. The primary effectiveness variable was progression-free survival in the first-line therapy setting (PFS-1). Secondary effectiveness variables included PFS after first progression as well as overall survival and overall response rate. All analyses were carried out descriptively for the full analysis population set (FAS). Effectiveness analyses were also assessed for predefined subgroups based on therapy goals. RESULTS: Between December 2012 and July 2016, 2,429 eligible patients were observed at 314 sites in Germany. In the first-line setting in the FAS, the median PFS-1 was 10.3 months (95% CI: 9.9; 10.8), the median overall survival was 16.9 months (95% CI: 16.3; 17.5), and the overall response rate (ORR-1) was 44.2% (95% CI: 41.6%; 46.8%). Effectiveness results of all subgroups were similar to the FAS. Overall, 80.9% of patients experienced any adverse events, 36.6% of patients experienced serious adverse events, and 8.8% of patients experienced fatal adverse events. CONCLUSION: The NIS KORALLE provided broad real-world evidence on effectiveness and safety of bevacizumab. Despite different treatment intentions, the combination of bevacizumab plus fluoropyrimidine-based chemotherapy was similarly effective in all subgroups in routine clinical practice. The safety information reported in this study is consistent with the known safety profile of bevacizumab.

[Obesity is rarely curable: individual concepts and therapy programs for children and adolescents]. / Adipositas ist nur selten heilbar: Individuelle Konzepte und Therapieprogramme für Kinder und Jugendliche.

Obesity in children has an increased risk to persist in adulthood. In most cases, obesity starts to develop in children at school age. Lower social economic status and migration background are severe risk factors for obesity. Additionally, genetic predisposition for the development of obesity plays an especially important role in children and adolescents. However, the individual cause for obesity is heterogeneous and complex. This is the reason why only a systematic analysis of individually existing problems is necessary for a differentiated and realistic planning of the treatment. Long-lasting therapy concepts need to be based on current available evidence.The treatment of childhood obesity should rely on multiprofessional lifestyle programs. An exception might be rare monogenic or syndromic forms of obesity, because defects within the central regulatory pathways of body weight regulation could be present. In general, a key component of the treatment strategy should include an improvement of nutrition, physical exercise and self-esteem combined with a reduction of stress. Moreover, the inclusion of parents into the treatment strategy has shown to be beneficial and necessary. Long-term follow-up studies on the development of associated comorbidities are rare. Unfortunately, patient groups at risk are currently not necessarily reached with available treatment programs.A multiprofessional analysis of individual problems and differentiated treatment planning with a participative approach (acknowledging the cultural background and involving members of the family) should lead to long-lasting improvement of the therapeutic outcome. The individual main treatment aim should also include - apart from the reduction of body weight - the improvement of associated comorbidities and quality of life, especially by avoiding any stigmatization. A health-promoting environment is desirable for this salutogenetic approach.

Goals of gout treatment: a patient perspective.

To assess the goals of gout treatment from a patient perspective, a convenience sample of consecutive patients with doctor-diagnosed gout seen at a community-based outpatient clinic were invited. Sex-stratified nominal groups were conducted until saturation was achieved. Responses were collected verbatim, discussed, and rank-ordered by each participant. Thirty-six patients with doctor-diagnosed gout participated in 12 nominal groups: 6 male only, 5 female only, and 1 group with both. Mean age was 61.9 years (SD, 12.3); mean gout duration was 13.3 years (SD, 12.5); 53% were men, 64% African-American, 42% retired, 47% currently married, 87% were using either allopurinol and/or febuxostat, and 40% had had no gout flares in the last 6 months. The top 5 treatment goals accounted for 91% of all votes and included the following: (1) prevent and better manage flare-ups and improve function (25%), (2) eliminate flare-ups/disease remission (30%), (3) diet and activity modification/lifestyle change (13%), (4) patient education and public awareness (12%), and (5) medication management and minimization of side effects (11%). When examining the top-rated concern for each nominal group, the first two goals were nominated by four groups each, diet/activity modification and medication management by 1 group each, and patient education by 3 groups. There were no differences evident by sex in top-ranked treatment goal. People with gout identified and rank-ordered treatment goals relevant to them. Providers of gout care need to be cognizant of these goals. Disease management concordant with these treatment goals might lead to a more satisfied, informed patient.

Relevance of therapy goals in outpatient cognitive-behavioral and psychodynamic psychotherapy.

OBJECTIVE: Against a background of sparse research and contradictory findings, the present study investigates determinants of psychotherapy goals and predictive value for therapy success in outpatient psychotherapy. METHOD: The sample consisted of 473 patients from a university-based polyclinic and their corresponding 103 therapists. Goals were coded with the Bern Inventory of Treatment Goals (BIT-T). RESULTS: The results show that goal congruence between therapists and patients is relatively small. Theoretical orientation had a significant influence on the complexity of goal structure and goal preferences. With regard to the prognostic validity, only patients' problem- and symptom-focused goals enabled the prediction of treatment success independent of basic therapeutic variables. CONCLUSIONS: These findings underline the importance of consideration of patients' individual treatment goals in clinical practice and underpin the relevance of therapy goals for future psychotherapy research.

What should we expect from psychotherapy?

In addressing the very general question of what we should expect from psychotherapy, this article begins by discussing what constitutes relevant evidence on which to base the efficacy and effectiveness of psychotherapy. In this context, an important distinction is made between empirically supported treatments and evidence-based practice. Although there is evidence that psychotherapy does indeed work, there are also findings that there are times when our patients are harmed by our interventions. It is noted that the therapeutic alliance plays an extremely important role in the change process, and that ruptures in the alliance can contribute to our therapeutic failures. In pointing to directions for the future, modifications of how we investigate the outcome of treatment, as well as how to close the gap between research and practice, are offered.