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1.
BMJ Open ; 12(6): e056973, 2022 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-35649607

RESUMO

INTRODUCTION: Many patients with cancer experience severe psychological distress, but as a result of various barriers, few of them receive psycho-oncological support. E-mental health interventions try to overcome some of these barriers and the limitation of healthcare offers, enabling patients with cancer to better cope with psychological distress. In the proposed trial, we aim to assess the efficacy and cost-effectiveness of the manualised e-mental health intervention Make It Training- Mindfulness-Based and Skills-Based Distress Reduction in Oncology. Make It Training is a self-guided and web-based psycho-oncological intervention, which includes elements of cognitive behavioural therapy, mindfulness-based stress reduction and acceptance and commitment therapy. The training supports the patients over a period of 4 months. We expect the Make It Training to be superior to treatment as usual optimised (TAU-O) in terms of reducing distress after completing the intervention (T1, primary endpoint). METHODS AND ANALYSIS: The study comprises a multicentre, prospective, randomised controlled confirmatory interventional trial with two parallel arms. The proposed trial incorporates four distinct measurement time points: the baseline assessment before randomisation, a post-treatment assessment and 3 and 6 month follow-up assessments. We will include patients who have received a cancer diagnosis in the past 12 months, are in a curative treatment setting, are 18-65 years old, have given informed consent and experience high perceived psychological distress (Hospital Anxiety and Depression Scale ≥13) for at least 1 week. Patients will be randomised into two groups (Make It vs TAU-O). The aim is to allocate 600 patients with cancer and include 556 into the intention to treat analysis. The primary endpoint, distress, will be analysed using a baseline-adjusted ANCOVA for distress measurement once the intervention (T1) has been completed, with study arm as a binary factor, baseline as continuous measurement and study centre as an additional categorical covariate. ETHICS AND DISSEMINATION: The Ethics Committee of the Medical Faculty Essen has approved the study (21-10076-BO). Results will be published in peer-reviewed journals, conference presentations, the project website, and among self-help organisations. TRIAL REGISTRATION NUMBER: German Clinical Trial Register (DRKS); DRKS-ID: DRKS00025213.


Assuntos
Terapia de Aceitação e Compromisso , Intervenção Baseada em Internet , Atenção Plena , Neoplasias , Adolescente , Adulto , Idoso , Humanos , Pessoa de Meia-Idade , Atenção Plena/métodos , Estudos Multicêntricos como Assunto , Neoplasias/terapia , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto , Adulto Jovem
2.
Clin Exp Allergy ; 52(12): 1422-1431, 2022 12.
Artigo em Inglês | MEDLINE | ID: mdl-35524545

RESUMO

BACKGROUND: Allergen immunotherapy (AIT) represents the only possibility of causal therapy for allergic respiratory diseases. Although the prevailing high prevalence of allergic diseases and restrictions in the daily lives of patients, AIT is offered to a suboptimal number of patients in Germany. METHODS: Insured patients with documented allergic respiratory disease of one of the largest statutory health insurances in Germany, 'DAK-Gesundheit', were contacted by postal mail and asked to participate in the study. In case of written consent, primary and secondary data of patients were collected and analysed. Patient characteristics, predictors of being offered AIT, predictors of performing AIT and guideline-compliant care were analysed. RESULTS: 2505 subjects were included in the VerSITA study. Allergy to tree pollen and native speaking were identified as predictors, which increase the probability of being offered AIT. The probability was significantly decreased by the characteristics allergic rhinitis only, allergic asthma only, age in years, non-German citizenship, no graduation and lower secondary qualification. Significant positive predictors for an AIT to be actually performed were: Allergy to tree pollen and male sex. Predictors that decrease the likelihood that AIT is performed were: only allergic asthma, current smoker, former smoker, age and non-German citizenship. Furthermore, it was possible to identify characteristics in which guideline-compliant patients differed significantly from the rest of the study population. CONCLUSIONS: Based on statutory health insurance data and patient survey data, the VerSITA study provides a broad and in-depth overview of the care situation with regard to AIT in Germany and identifies deficits.


Assuntos
Asma , Rinite Alérgica , Humanos , Dessensibilização Imunológica , Rinite Alérgica/epidemiologia , Rinite Alérgica/terapia , Pólen , Alemanha/epidemiologia , Alérgenos
3.
Eur Arch Psychiatry Clin Neurosci ; 268(6): 611-619, 2018 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-28791485

RESUMO

In Germany, a regional social health insurance fund provides an integrated care program for patients with schizophrenia (IVS). Based on routine data of the social health insurance, this evaluation examined the effectiveness and cost-effectiveness of the IVS compared to the standard care (control group, CG). The primary outcome was the reduction of psychiatric inpatient treatment (days in hospital), and secondary outcomes were schizophrenia-related inpatient treatment, readmission rates, and costs. To reduce selection bias, a propensity score matching was performed. The matched sample included 752 patients. Mean number of psychiatric and schizophrenia-related hospital days of patients receiving IVS (2.3 ± 6.5, 1.7 ± 5.0) per quarter was reduced, but did not differ statistically significantly from CG (2.7 ± 7.6, 1.9 ± 6.2; p = 0.772, p = 0.352). Statistically significant between-group differences were found in costs per quarter per person caused by outpatient treatment by office-based psychiatrists (IVS: €74.18 ± 42.30, CG: €53.20 ± 47.96; p < 0.001), by psychiatric institutional outpatient departments (IVS: €4.83 ± 29.57, CG: €27.35 ± 76.48; p < 0.001), by medication (IVS: €471.75 ± 493.09, CG: €429.45 ± 532.73; p = 0.015), and by psychiatric outpatient nursing (IVS: €3.52 ± 23.83, CG: €12.67 ± 57.86, p = 0.045). Mean total psychiatric costs per quarter per person in IVS (€1117.49 ± 1662.73) were not significantly lower than in CG (€1180.09 ± 1948.24; p = 0.150). No statistically significant differences in total schizophrenia-related costs per quarter per person were detected between IVS (€979.46 ± 1358.79) and CG (€989.45 ± 1611.47; p = 0.084). The cost-effectiveness analysis showed cost savings of €148.59 per reduced psychiatric and €305.40 per reduced schizophrenia-related hospital day. However, limitations, especially non-inclusion of costs related to management of the IVS and additional home treatment within the IVS, restrict the interpretation of the results. Therefore, the long-term impact of this IVS deserves further evaluation.


Assuntos
Assistência Ambulatorial , Análise Custo-Benefício , Prestação Integrada de Cuidados de Saúde , Hospitalização , Hospitais Psiquiátricos , Seguro Saúde , Ambulatório Hospitalar , Esquizofrenia , Adulto , Assistência Ambulatorial/economia , Assistência Ambulatorial/estatística & dados numéricos , Prestação Integrada de Cuidados de Saúde/economia , Prestação Integrada de Cuidados de Saúde/estatística & dados numéricos , Feminino , Alemanha , Hospitalização/economia , Hospitalização/estatística & dados numéricos , Hospitais Psiquiátricos/economia , Hospitais Psiquiátricos/estatística & dados numéricos , Humanos , Seguro Saúde/economia , Seguro Saúde/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Ambulatório Hospitalar/economia , Ambulatório Hospitalar/estatística & dados numéricos , Esquizofrenia/economia , Esquizofrenia/terapia
4.
Rehabilitation (Stuttg) ; 56(5): 305-312, 2017 Oct.
Artigo em Alemão | MEDLINE | ID: mdl-28482369

RESUMO

The aim of the project is a cost analysis of 2 different strategies "train-the-trainer-seminar" (ttt-seminar) and "implementation guideline" (ig) in the implementation of a standardised patient education program in the inpatient rehabilitation of patients with chronic back pain. The implementation strategies were assigned by chance to 10 rehabilitation clinics. Expenditure of time was evaluated by questionnaire. Additionally materials and travel expenses were calculated. The total implementation costs accounted 4 582 € for the ttt-seminar and were about one third (35%) higher than the costs for the ig-strategy. The higher total implementation costs can basically be attributed to higher personnel costs due to the time-consuming seminar. However, in the ig-strategy postprocessing costs were 23.5% higher than in the ttt-strategy.


Assuntos
Dor nas Costas/reabilitação , Implementação de Plano de Saúde/economia , Disseminação de Informação/métodos , Educação de Pacientes como Assunto/economia , Custos e Análise de Custo , Currículo , Alemanha , Fidelidade a Diretrizes/economia , Fidelidade a Diretrizes/organização & administração , Recursos em Saúde/economia , Humanos , Programas Nacionais de Saúde/economia , Equipe de Assistência ao Paciente/economia , Equipe de Assistência ao Paciente/organização & administração , Educação de Pacientes como Assunto/métodos , Capacitação de Professores/economia , Capacitação de Professores/métodos
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