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OBJECTIVE: Eating disorders (EDs) increasingly emerge as a health risk in men, but there is concern that men's symptoms go unnoticed due to stereotypical perceptions and gender-related differences in symptom presentation. Novel assessments focused particularly on attitudes and behaviours towards increasing muscle size and definition. Using network analysis, this study aimed to corroborate and extend previous findings on disordered eating presentation in men by examining the role of muscularity concerns among an extended range of disordered eating symptoms. METHOD: N = 294 adult men (18 years or older) completed muscularity-related and disordered eating assessments, among which we included assessments for orthorexic eating and Avoidant/Restrictive Food Intake Disorder for the first time. We selected symptoms empirically, estimated a regularised network, identified symptom communities, evaluated network loadings and bridge centrality estimates, and compared network structures between different groups of participants. RESULTS: We identified five symptom communities related to muscularity-related concerns, features of core ED psychopathology, and selective eating. Symptoms regarding ruminating about healthy eating, guilt for unhealthy eating, weight overvaluation, concerns about muscularity, and selective eating emerged as highly central. DISCUSSION: The results largely corroborate previous observations but suggest that muscle-building behaviours are part of a broader cluster of male body shaping and rule-based dieting behaviours.
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BACKGROUND: Primary ciliary dyskinesia (PCD) is a rare genetical disease with malfunction of the motile cilia leading to impaired muco-ciliary clearance in the respiratory tract. There is no cure for PCD, only supportive therapy aimed at minimizing the progression of the disease and improving the patient's quality of life (QoL). Physical activity (PA) is one of these recommended supportive therapies for people with PCD (pwPCD). However, there is no scientific evidence to support this recommendation. In addition, regular medical advice to increase PA remains largely ineffective in pwPCD. METHODS: To test the main hypothesis, that an individualized and supported PA program leads to a better QoL 6 months after randomization (QoL-PCD questionnaire) compared to usual recommendation in pwPCD, 158 pwPCD aged 7 to 55 years are to be included in this multi-center randomized controlled trial (RCT). After the screening visit, a 1:1 randomization stratified by age group and FEV1 will be performed. A QoL-PCD questionnaire, motor test, and lung function will be carried out at regular intervals in both groups. PA is recorded in both groups using activity trackers during the study period. The main aim of the trial is to estimate the difference in the change of QoL between the groups after 6 months. Therefore, our full analysis set consists of all randomized patients and analysis is performed using the intention-to-treat principle. Statistical software R ( http://www.r-project.org ) is used. Ethical approvement without any reservations: RUB Bochum Ethics Committee (No. 23-7938; December 4, 2023). Recruitment start: March 2024. DISCUSSION: Limitations result from the rarity of PCD with its broad disease spectrum and the large age range. These are reduced by stratified randomization and the measurement of the individual change in QoL as primary endpoint. In our view, only a PA program tailored to individual needs with close contact to trainers offers the chance to meet personal needs of pwPCD and to establish PA as a pillar of therapy in the long term. The study protocol explains all procedures and methods of recruitment, implementation of the study visits and intervention, measures for patient and data safety, and for minimizing risks and bias. TRIAL REGISTRATION: German Clinical Trials Register (DRKS) 00033030. Registered on December 7, 2023. Update 10 July 2024. STUDY PROTOCOL VERSION 10: Version 1.2; 12 June 2024.
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Estudos Multicêntricos como Assunto , Qualidade de Vida , Humanos , Adolescente , Criança , Adulto Jovem , Adulto , Pessoa de Meia-Idade , Masculino , Feminino , Exercício Físico , Estudos Longitudinais , Terapia por Exercício/métodos , Estudos de Equivalência como Asunto , Resultado do Tratamento , Fatores de Tempo , Ensaios Clínicos Controlados Aleatórios como Assunto , Inquéritos e Questionários , Transtornos da Motilidade Ciliar/terapia , Síndrome de Kartagener/terapia , Síndrome de Kartagener/fisiopatologiaRESUMO
Patients with sepsis experience metabolic and immunologic dysfunction that may be amplified by standard carbohydrate-based nutrition. A ketogenic diet (KD) may offer an immunologically advantageous alternative, although clinical evidence is limited. We conducted a single-center, open-label, randomized controlled trial to assess whether a KD could induce stable ketosis in critically ill patients with sepsis. Secondary outcomes included assessment of feasibility and safety of KD, as well as explorative analysis of clinical and immunological characteristics. Forty critically ill adults were randomized to either a ketogenic or standard high-carbohydrate diet. Stable ketosis was achieved in all KD patients, with significant increases in ß-hydroxybutyrate levels compared with controls [mean difference 1.4 milimoles per liter; 95% confidence interval (CI): 1.0 to 1.8; P < 0.001). No major adverse events or harmful metabolic side effects (acidosis, dysglycemia, or dyslipidemia) were observed. After day 4, none of the patients in the KD group required insulin treatment, whereas in the control group, insulin dependency ranged between 35% and 60% (P = 0.009). There were no differences in 30-day survival, but ventilation-free [incidence rate ratio (IRR) 1.7; 95% CI: 1.5 to 2.1; P < 0.001], vasopressor-free (IRR 1.7; 95% CI: 1.5 to 2.0; P < 0.001), dialysis-free (IRR 1.5; 95% CI: 1.3 to 1.8; P < 0.001), and intensive care unit-free days (IRR 1.7; 95% CI: 1.4 to 2.1; P < 0.001) were higher in the ketogenic group. Next-generation sequencing of CD4+/CD8+ T cells and protein analyses showed reduced immune dysregulation, with decreased gene expression of T-cell activation and signaling markers and lower pro-inflammatory cytokine secretion. This trial demonstrated the safe induction of a stable ketogenic state in sepsis, warranting larger trials to investigate potential benefits in sepsis-related organ dysfunction.
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Estado Terminal , Dieta Cetogênica , Sepse , Humanos , Masculino , Sepse/dietoterapia , Sepse/sangue , Feminino , Pessoa de Meia-Idade , Ácido 3-Hidroxibutírico/sangue , Adulto , Idoso , Cetose , Resultado do TratamentoRESUMO
OBJECTIVE: An effective tool for establishing concordant end-of-life (EOL) care in patients with cancer is advance care planning (ACP). However, various barriers, including psychological obstacles, hamper the access to ACP. Therefore, a new conceptual model combining a psycho-oncological approach with structured ACP was developed. The effectiveness and efficiency of this new concept of collaborative ACP (col-ACP) is evaluated in the present randomised controlled trial in patients with palliative cancer. METHODS: 277 patients with palliative cancer and their relatives were randomised into three groups (1) collaborative ACP (col-ACP) consisting of a psycho-oncological approach addressing barriers to EOL conversations followed by a standardised ACP procedure, (2) supportive intervention (active control) and (3) standard medical care. RESULTS: Patients in the col-ACP group completed advance directives (p<0.01) and healthcare proxies (p<0.01) significantly more often. Additionally, they felt better planned ahead for their future treatment (p<0.01) and were significantly more confident that their relatives were aware of their treatment wishes (p=0.03). In fact, their goals of care were known and highly fulfilled. However, patients' and caregivers' quality of life, patients' stress, depression and peace did not differ between the groups. CONCLUSIONS: The new, well-received, concept of col-ACP improves readiness and access to ACP and results in more consistent EOL care. Further, even if no direct influence on quality of life could be proven, it supports patients in planning their treatment, making autonomous decisions and regaining self-efficacy in the face of life-limiting cancer. Therefore, a closer interlocking and information exchange between psycho-oncological and ACP services seems to be reasonable. TRIAL REGISTRATION NUMBER: NCT03387436.
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OBJECTIVES: To report CD19+ B-cell counts and possible adverse effects on infants of mothers exposed to anti-CD20 mAbs ≤6 months before/during pregnancy or lactation. METHODS: We conducted a retrospective study using data from the German nationwide neuroimmunologic pregnancy registry. Inclusion criteria involved infants whose mothers received anti-CD20 mAbs ≤6 months before/during pregnancy or lactation, with ≥1 postnatal CD19+ B-cell count. Main outcomes were absolute and relative CD19+ B-cell counts. Comparison with reference values was performed conservatively in a subgroup with maternal exposure ≤3 months before/during pregnancy. Additional outcomes included pregnancy results, severe infections, and lymphocyte counts. RESULTS: The cohort comprised 49 infants (F:M 25:24) exposed to anti-CD20 mAbs ≤6 months before/during pregnancy or lactation. CD19+ B-cell and lymphocyte counts in 40 infants with maternal exposure ≤3 months before/during pregnancy were comparable with normative values. Only 2 cases of complete CD19+ B-cell depletion occurred after second-trimester and third-trimester ocrelizumab exposure, with repopulation observed within 2 months. Exclusive lactation exposure had no significant effect on infants' absolute CD19+ B-cell counts. DISCUSSION: Administering anti-CD20 mAbs before or at the pregnancy onset, or during lactation, seems safe without significant impact on infant B-cell development. However, second-trimester or third-trimester exposure can cause CD19+ B-cell depletion due to placental transfer, necessitating monitoring and postponing live vaccines.
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Antígenos CD20 , Linfócitos B , Lactação , Humanos , Feminino , Gravidez , Recém-Nascido , Linfócitos B/imunologia , Linfócitos B/efeitos dos fármacos , Estudos Retrospectivos , Lactação/imunologia , Masculino , Adulto , Antígenos CD20/imunologia , Saúde do Lactente , Efeitos Tardios da Exposição Pré-Natal/imunologia , Efeitos Tardios da Exposição Pré-Natal/induzido quimicamente , Antígenos CD19/imunologia , Contagem de Linfócitos , Rituximab/efeitos adversos , Rituximab/administração & dosagem , Rituximab/farmacologia , Fatores Imunológicos/efeitos adversos , Fatores Imunológicos/administração & dosagem , Fatores Imunológicos/farmacologia , LactenteRESUMO
Background: Intrusive memories form a core symptom of Posttraumatic Stress Disorder (PTSD). Based on concepts of visuospatial interference and memory-updating accounts, technological innovations aim to attenuate such intrusions using visuospatial interventions.Objective: This study aims to test the effect of a visuospatial Tetris-based intervention versus a verbal condition (Wiki) and a never-targeted control (no intervention) on intrusion frequency.Method: A randomized crossover trial was conducted including N = 38 PTSD patients who had at least 3 distinct intrusive memories of trauma. After both 2 weeks (intervention 1) and 4 weeks (intervention 2), one of the three memories was randomly selected and either the visuospatial intervention (memory reminder of a traumatic memory + Tetris) or verbal condition (reading a Wikipedia article + answering questions) was performed on their first memory in randomized order. In the week 4 session, the patient conducted the other intervention condition on their second memory (crossover). The third memory was never targeted (no intervention). Daily occurrence of intrusions over 8 weeks was collected using a diary and analysed using mixed Poisson regression models.Results: Overall, there was no significant reduction in intrusion frequency from either intervention compared to each other, and to no intervention control (relative risk Tetris/Wiki: 0.947; p = .31; relative risk no intervention/Tetris: 1.060; p = .15; relative risk no intervention/Wiki: 1.004; p = .92).Conclusions: There was no effect of either intervention on intrusions when administered in a crossover design where participants received both interventions. Design shortcomings and consequences for future studies are discussed.
Visuospatial interventions, including the computer game Tetris, have been studied as a potential means to decrease intrusive memories, a core feature of Posttraumatic Stress Disorder.In this study, two interventions are tested in a crossover design with patients with intrusive memories after traumatic experiences.There was no effect of either the visuospatial intervention or the verbal condition in this design.
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Transtornos de Estresse Pós-Traumáticos , Jogos de Vídeo , Humanos , Cognição , Transtornos de Estresse Pós-Traumáticos/terapia , Estudos Cross-OverRESUMO
BACKGROUND: Vulnerability to infectious diseases in refugees is dependent on country of origin, flight routes, and conditions. Information on specific medical needs of different groups of refugees is lacking. We assessed the prevalence of infectious diseases, immunity to vaccine-preventable diseases, and chronic medical conditions in children, adolescents, and adult refugees from Ukraine who arrived in Germany in 2022. METHODS: Using different media, we recruited Ukrainian refugees at 13 sites between 9-12/2022. An antigen test for acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) infection, serologies for a range of vaccine-preventable diseases, as well as interferon gamma release assays (IGRAs) for tuberculosis (TB), and SARS-CoV-2 were performed. We assessed personal and family history of chronic medical conditions, infectious diseases, vaccination status, and conditions during migration. RESULTS: Overall, 1793 refugees (1401 adults and 392 children/adolescents) were included. Most participants were females (n = 1307; 72·3%) and from Eastern or Southern Ukraine. TB IGRA was positive in 13% (n = 184) of the adults and in 2% (n = 7) of the children. Serology-based immunological response was insufficient in approximately 21% (360/1793) of the participants for measles, 32% (572/1793) for diphtheria, and 74% (1289/1793) for hepatitis B. CONCLUSIONS: We show evidence of low serological response to vaccine-preventable infections and increased LTBI prevalence in Ukrainian refugees. These findings should be integrated into guidelines for screening and treatment of infectious diseases in migrants and refugees in Germany and Europe. Furthermore, low immunity for vaccine-preventable diseases in Ukrainians independent of their refugee status, calls for tailor-made communication efforts.
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Doenças Transmissíveis , População do Leste Europeu , Refugiados , Tuberculose , Doenças Preveníveis por Vacina , Adolescente , Adulto , Criança , Feminino , Humanos , Masculino , Doenças Transmissíveis/epidemiologia , Estudos Transversais , Alemanha/epidemiologia , Prevalência , Tuberculose/epidemiologia , Tuberculose/prevenção & controle , UniversidadesRESUMO
BACKGROUND: Inappropriate drug prescriptions for patients with polypharmacy can have avoidable adverse consequences. We studied the effects of a clinical decision-support system (CDSS) for medication management on hospitalizations and mortality. METHODS: This stepped-wedge, cluster-randomized, controlled trial involved an open cohort of adult patients with polypharmacy in primary care practices (=clusters) in Westphalia-Lippe, Germany. During the period of the intervention, their medication lists were checked annually using the CDSS. The CDSS warns against inappropriate prescriptions on the basis of patient-related health insurance data. The combined primary endpoint consisted of overall mortality and hospitalization for any reason. The secondary endpoints were mortality, hospitalizations, and high-risk prescription. We analyzed the quarterly health insurance data of the intention- to-treat population with a mixed logistic model taking account of clustering and repeated measurements. Sensitivity analyses addressed effects of the COVID-19 pandemic and other effects. RESULTS: 688 primary care practices were randomized, and data were obtained on 42 700 patients over 391 994 quarter years. No significant reduction was found in either the primary endpoint (odds ratio [OR] 1.00; 95% confidence interval [0.95; 1.04]; p = 0.8716) or the secondary endpoints (hospitalizations: OR 1.00 [0.95; 1.05]; mortality: OR 1.04 [0.92; 1.17]; high-risk prescription: OR 0.98 [0.92; 1.04]). CONCLUSION: The planned analyses did not reveal any significant effect of the intervention. Pandemicadjusted analyses yielded evidence that the mortality of adult patients with polypharmacy might potentially be lowered by the CDSS. Controlled trials with appropriate follow-up are needed to prove that a CDSS has significant effects on mortality in patients with polypharmacy.
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Sistemas de Apoio a Decisões Clínicas , Hospitalização , Polimedicação , Humanos , Alemanha , Feminino , Masculino , Idoso , Sistemas de Apoio a Decisões Clínicas/estatística & dados numéricos , Hospitalização/estatística & dados numéricos , Pessoa de Meia-Idade , Prescrição Inadequada/estatística & dados numéricos , Prescrição Inadequada/prevenção & controle , Atenção Primária à Saúde/estatística & dados numéricos , Idoso de 80 Anos ou mais , COVID-19/mortalidade , Adulto , SARS-CoV-2RESUMO
BACKGROUND: Findings from randomized trials (RCTs) on cervical pessary treatment to prevent spontaneous preterm birth are inconsistent. OBJECTIVES: Our hypothesis suggests that adhering to the European Medical Device Regulation (MDR) and following the instructions for use are essential prerequisites for successful therapy. Conversely, the non-adherence to these guidelines will probably contribute to its failure. SEARCH STRATEGY AND SELECTION CRITERIA: Based on validated criteria from integrity assessments we performed a systematic review identifying 14 RCTs evaluating the effect of cervical pessaries. DATA COLLECTION AND ANALYSIS: We analyzed the implications of 14 criteria each accounting for 0-2 points of a score reflecting the clinical evaluation plan (CEP) as proposed by the MDR to evaluate the risk-benefit ratio of medical devices. MAIN RESULTS: Seven RCTs in each singleton and twin pregnancies (5193 "cases") were included, detecting a high heterogeneity within control groups (I2 = 85% and 87%, respectively, P < 0.01). The CEP score varied from 11 to 26 points for all studies. The most common reasons for low scores and potential data compromise were poor recruitment rates, no (completed) power analysis, and no pre-registration, but mainly non-adherence to technical, biological, and clinical equivalence to the instructions for use as required by the MDR. All trials with score values greater than 20 had applied audit procedures. Within this group we found significantly reduced rates of spontaneous preterm birth at less than 34 weeks within the pessary group in singleton (odds ratio 0.28; 95% confidence interval 0.12-0.65) and twin pregnancies (odds ratio 0.30; 95% confidence interval 0.13-0.67). Similarly, there was a significant reduction in the composite poor neonatal outcome in singleton (odds ratio 0.25; 95% confidence interval 0.10-0.61) and twin pregnancies (odds ratio 0.54; 95% confidence interval 0.35-0.82) after a pessary as compared with controls. CONCLUSION: Non-audited RCTs and meta-analyses mixing studies of different clinical quality as pre-defined by a CEP and the MDR pose the risk for erroneous conclusions.
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Nascimento Prematuro , Gravidez , Recém-Nascido , Feminino , Humanos , Nascimento Prematuro/prevenção & controle , Pessários , Legislação de Dispositivos Médicos , Ensaios Clínicos Controlados Aleatórios como Assunto , Colo do Útero , Gravidez de GêmeosRESUMO
BACKGROUND: Relapse risk after delivery is increased in women with active multiple sclerosis (MS), the best strategy to reduce it is unknown. We aimed to assess the association of four different postpartum strategies with relapses during the first 6 months post partum. METHODS: This cohort study includes data prospectively collected through structured telephone interviews from the German Multiple Sclerosis and Pregnancy Registry. Pregnancies with active MS (fingolimod or natalizumab treatment OR relapse within 1 year before pregnancy) and postpartum follow-up of ≥6 months were included. We compared four strategies: (1) intention to breastfeed exclusively without disease-modifying therapy (DMT) (exclusive breast feeding ≥2 months or switching to non-exclusive/weaning within 2 weeks after a relapse during the first 2 months), (2) early treatment with natalizumab/fingolimod and (3) other DMT initiated within 6 weeks post partum before a relapse. If women did not or only partially breastfed, or started DMT≤6 weeks after delivery after a relapse or later, we assumed (4) no-DMT-no-exclusive- breastfeeding-strategy. Main outcome was time to postpartum MS relapses. RESULTS: In 867 women with 911 pregnancies, most (n=416) intended to breastfeed exclusively or had no-DMT-no-exclusive-breastfeeding-strategy (n=290); fewer started fingolimod (n=38), natalizumab (n=74) or another DMT (n=93) early. Recurrent time-to-event analysis showed a statistically significant reduction in relapse hazard only with the natalizumab/fingolimod-strategy as of months 3-4 post partum compared with intention-to-breastfeed-exclusively-strategy. The very early relapse risk was highest in no-DMT-no-exclusive-breastfeeding-strategy. CONCLUSION: In active MS, an early postpartum treatment strategy should be determined well before delivery. Natalizumab/fingolimod-strategy reduced postpartum relapse hazard from month 3, but none diminished the early postpartum relapse hazard.
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Esclerose Múltipla Recidivante-Remitente , Esclerose Múltipla , Gravidez , Feminino , Humanos , Esclerose Múltipla/tratamento farmacológico , Natalizumab/uso terapêutico , Estudos de Coortes , Cloridrato de Fingolimode/uso terapêutico , Período Pós-Parto , Recidiva , Esclerose Múltipla Recidivante-Remitente/tratamento farmacológico , ImunossupressoresRESUMO
Internet Use Disorders (IUD) have a relevant effect on national economies. In the randomized, controlled, multicenter, prospective, and single-blinded OMPRIS study (pre-registration number DRKS00019925; Innovation Fund of the Joint Federal Committee of Germany, grant number 01VSF18043), a four-week online program to reduce media addiction symptoms, was evaluated for cost-effectiveness. The intervention group (IG) was compared to a waiting control group (WCG) from German statutory health insurance (SHI) and a societal perspective. Resource use, namely indirect and direct (non) medical costs, was assessed by a standardized questionnaire at baseline and after the intervention. Additionally, intervention costs were calculated. Determining the Reliable Change Index (RCI) based on the primary outcome, assessed by the "Scale for the Assessment of Internet and Computer Game Addiction" (AICA-S), individuals with and without reliable change (RC) were distinguished. The incremental cost-effectiveness ratio was calculated using the difference-in-difference approach. There were 169 (IG n = 81, WCG n = 88) persons included in the analysis. The mean age was 31.9 (SD 12.1) years. A total of 75.1% were male, and 1.8% diverse. A total of 65% (IG) and 27% (WCG) had an RC. The cost per person with RC was about EUR 860 (SHI) and EUR 1110 (society). The intervention leads to an improvement of media addiction symptoms at moderate additional costs.
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Transtorno de Adição à Internet , Uso da Internet , Motivação , Adulto , Feminino , Humanos , Masculino , Análise Custo-Benefício , Internet , Estudos Prospectivos , Inquéritos e Questionários , Transtorno de Adição à Internet/economia , Transtorno de Adição à Internet/psicologia , Transtorno de Adição à Internet/terapiaRESUMO
OBJECTIVES: Advance care discussions are a useful communication tools for medical preferences and beneficial for shared decision-making processes in hospital settings. The present study developed the first screening tool for need for advance care planning (ACP). METHODS: In phase 1 (n=92), items were evaluated using feasibility analysis and item reduction. In phase 2 (n=201), reduced screening items were analysed for predictive value of need for ACP. Statistical analysis included receiver-operating characteristics analysis (area under the curve>0.80), optimal cut-off based on sensitivity and specificity, interpretation of OR and construct validity using correlation with death anxiety, communication avoidance within families and trust based on the relationship with the treating physician. RESULTS: Participants in both phases were approximately 60 years old with non-curative prognosis. After item reduction, predictive values of four possible items with good item difficulty and discrimination were compared for mild, moderate and great levels of death anxiety. A two-item combination of I am burdened by thoughts of an unfavourable course of the disease and I am burdened by the feeling of being ill-prepared for the end of life showed best prediction of death anxiety and communication avoidance. Clinical cut-off at sum-score ≥6 was of high sensitivity (95%) and specificity (81%). Previous use of social support and readiness for ACP was related to higher chance of interest in ACP. CONCLUSION: Screening for need of ACP is possible with two objective items and one subjective item. Positive screening therefore indicates when to offer ACP discussions and provides routine estimation of ACP need in clinical practice.
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Delay in diagnosing multidrug-resistant tuberculosis (MDR-pTB) in children prolongs time to effective treatment. Data on risk factors for pediatric MDR from low-incidence countries are scarce. Retrospective nationwide case-control study to analyze MDR-pTB cases in Germany between 2010 and 2020 in comparison to a drug-susceptible (DS)-pTB group. We included 52 MDR cases (24 tuberculosis (TB), 28 TB infection (TBI); mean age 7.3 years) and 56 DS cases (31 TB, 26 TBI; mean age 7.9 years). Groups were similar for sex, household size, and migration background. Compared to the DS group, more children with MDR were born in the Commonwealth of Independent States (CIS) (22% MDR-pTB vs. 13% DS-pTB, n.s.) and had more MDR index cases (94% MDR-pTB, 5% DS-pTB, p < 0.001). The interval between first healthcare contact and initiation of effective therapy was significantly longer in MDR-pTB (47 days) than in DS-pTB (11 days, p < 0.001), correlating with disease progression. Treatment for MDR-pTB was successful in 74%, but 22% experienced long-term adverse effects (e.g., hepatopathy, hearing loss). CONCLUSIONS: Close contact to MDR cases or birth in MDR-TB-high-incidence countries are risk factors for MDR-pTB. Early identification of potential MDR index cases by contact investigation, and susceptibility testing in children from high-burden MDR-TB countries are essential for timely diagnosis and treatment, reducing the severity of disease and treatment side effects. TRIAL REGISTRATION: Deutsches Register Klinischer Studien ( https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00023817 ), DRKS00023817, 2020-09-08. WHAT IS KNOWN: â¢Management of children with MDR-TB remains challenging due to difficulties in diagnosing MDR-TB (lack of information on MDR index case, lack of microbiological confirmation in paucibacillary disease). â¢Choice of treatment regimen and monitoring of side effects. WHAT IS NEW: â¢Children with an MDR-TB index or born in a MDR-TB-high-incidence country are at higher risk of developing MDR-TB in a low incidence country. â¢The time lag to initiate treatment in MDR-TB is longer than in DS-TB and MDR-TB treatment involves a higher risk of adverse effects in longer treatment regimens especially with injectables.
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Tuberculose Resistente a Múltiplos Medicamentos , Tuberculose , Humanos , Criança , Estudos Retrospectivos , Estudos de Casos e Controles , Tuberculose Resistente a Múltiplos Medicamentos/diagnóstico , Tuberculose Resistente a Múltiplos Medicamentos/tratamento farmacológico , Tuberculose Resistente a Múltiplos Medicamentos/epidemiologia , Tuberculose/tratamento farmacológico , Fatores de Risco , Doenças Raras , Antituberculosos/uso terapêuticoRESUMO
Background: Evidence-based treatments for internet use disorders (IUDs) are limited, and online therapy approaches are poorly studied. We investigated the efficacy of a manualised therapist-guided online intervention (OMPRIS) to reduce IUD symptoms and improve psychological well-being. Methods: In this multicentre, two-arm, single-blinded trial, individuals ≥16 years suffering from IUD symptoms were recruited in Germany from August 16, 2020, to March 11, 2022, through media advertisements and healthcare providers. Participants were randomly allocated by sequential balancing randomisation (1:1) to either the manualised webcam-based OMPRIS intervention or a waitlist control (WLC) group. OMPRIS provided strategies from motivational interviewing, behavioural therapy, and social counselling. The primary outcome at the end of treatment was a reduction in IUD symptoms as measured by the Assessment of Internet and Computer Scale (AICA-S). Follow-up assessments were conducted at 6 weeks and 6 months. Analyses were performed in the intention-to-treat population. This trial was registered (German Clinical Trial Register, DRKS00019925) and has been completed. Findings: A total of 180 individuals were randomly assigned to the OMPRIS intervention (n = 89) or WLC (n = 91) arm. After treatment, 81 (91.0%) participants in the OMPRIS intervention group and 88 (96.7%) in the WLC group completed the outcome assessment. The ANCOVA model showed that OMPRIS participants had a significantly greater reduction in AICA-S scores from baseline (mean score 12.1 [SD 4.6]) to post-treatment (6.8 [5.2]) than those in the WLC group (from 12.6 [5.1] to 11.0 [5.4]; estimated mean difference -3.9; [95% CI -5.2 to -2.6]; p < 0.0001; d = 0.92). No adverse events were reported to the trial team. Interpretation: Webcam-based OMPRIS therapy was effective and superior to waiting list conditions in reducing IUD symptoms. Webcam-based, specialised online therapy thus increases IUD treatment options. Funding: German Innovation Fund of Germany's Federal Joint Committee (G-BA), grant number 01VSF18043.
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BACKGROUND: Despite attempts to improve the cross-sectoral flow of information, difficulties remain in routine healthcare. The resulting negative impact on continuity of care is often associated with poor health outcomes, especially in older patients. Our intervention aims to increase information availability with respect to medications and health conditions at the interface between inpatient and outpatient care and to contribute towards improving the quality of care in older patients. This pilot study focuses on feasibility and implementability. METHODS: The idea of the complex intervention has been developed in a previous study. This intervention will be tested in a prospective, multicenter, cluster-randomized (via web tool), controlled pilot trial with two parallel study arms (intervention and control group). The pilot study will be conducted in 20 general practices in Hesse and Saxony (Germany) and include 200 patients (≥ 65 years of age with multimorbidity and polypharmacy) recruited by the practices. Practice staff and patients will be blinded. We will use qualitative and quantitative methods to assess the feasibility and implementability of the intervention and the study design in a process evaluation covering topics ranging from expectations to experiences. In addition, the feasibility of proposed outcome parameters for the future definitive trial will be explored. The composite endpoint will include health-related patient outcomes (hospitalization, falls, and mortality using, e.g., the FIMA questionnaire), and we will assess information on medications (SIMS questionnaire), symptoms and side effects of the medication (pro-CTCAE questionnaire), and health literacy (HLQ questionnaire). Data will be collected at study begin (baseline) and after 6 months. Furthermore, the study will include surveys and interviews with patients, general practitioners, and healthcare assistants. DISCUSSION: The intervention was developed using a participatory approach involving stakeholders and patients. It aims to empower general practice teams as they provide patient-centered care and play a key role in the coordination and continuity of care. We aim to encourage patients to adopt an active role in their health care. Overall, we want to increase the availability of health-related information for patients and healthcare providers. The results of the pilot study will be used in the design and implementation of the future definitive trial. TRIAL REGISTRATION: The study was registered in DRKS-German Clinical Trials Register: registration number DRKS00027649 (date: 19 January 2022). Date and version identifier 10.07.2023; Version 1.3.
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Visualization is a key aspect of communicating the results of any study aiming to estimate causal effects. In studies with time-to-event outcomes, the most popular visualization approach is depicting survival curves stratified by the variable of interest. This approach cannot be used when the variable of interest is continuous. Simple workarounds, such as categorizing the continuous covariate and plotting survival curves for each category, can result in misleading depictions of the main effects. Instead, we propose a new graphic, the survival area plot, to directly depict the survival probability over time and as a function of a continuous covariate simultaneously. This plot utilizes g-computation based on a suitable time-to-event model to obtain the relevant estimates. Through the use of g-computation, those estimates can be adjusted for confounding without additional effort, allowing a causal interpretation under the standard causal identifiability assumptions. If those assumptions are not met, the proposed plot may still be used to depict noncausal associations. We illustrate and compare the proposed graphics to simpler alternatives using data from a large German observational study investigating the effect of the Ankle-Brachial Index on survival. To facilitate the usage of these plots, we additionally developed the contsurvplot R-package, which includes all methods discussed in this paper.
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Probabilidade , HumanosRESUMO
OBJECTIVES: Various measures are used to improve the quality of stroke care. In Germany, these include concentrating treatment in specialized facilities (stroke units), mandatory quality comparisons of hospitals in some German states, and treatment according to prespecified structure and process specifications (neurological complex treatment 8-981 or 8-98b). These measures have previously only been analyzed individually and regarding short-term patient outcomes. This study analyzes these measures in combination, considering patients' comorbidities as well as stroke severity in a longitudinal perspective. MATERIALS/METHODS: Analyses were based on data from 243,415 insurees of Germany's biggest health insurance (AOK) admitted to hospitals between 2007 and 2017 with cerebral infarction. Mortality risk was calculated using Cox regressions adjusted for various covariates. Kaplan-Meier analyses were differentiated by treatment site (stroke unit/external quality assurance/ Federal State Consortium of Quality Assurance Hesse - LAGQH) were performed, followed by log-rank tests and p-value adjustment. Trend analyses were performed for treatment types in combination with treatment sites. RESULTS: All analyses showed significant advantages for patients who received Neurological Complex Treatment, especially when the treatment was performed under external quality assurance conditions and/or in stroke units. There was an increasing frequency of specialized stroke treatment. CONCLUSIONS: Quality-enhancing structures and processes are associated with a lower mortality risk after stroke. There appears to be evidence of a cascading benefit from the implementation of neurological complex treatment, external quality assurance, and ultimately, stroke units. Consecutively, care should be concentrated in hospitals that meet these specifications. However, since measures are often applied in combination, it remains unclear which specific measures are crucial for patient outcome.
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Acidente Vascular Cerebral , Humanos , Resultado do Tratamento , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/terapia , Hospitais , Hospitalização , Comorbidade , AlemanhaRESUMO
BACKGROUND AND OBJECTIVE: Discontinuation of fingolimod ≥2 months before pregnancy is recommended to minimize potential teratogenicity. The magnitude of MS pregnancy relapse risk, particularly severe relapses, after fingolimod cessation is unclear, as is whether this risk is reduced by pregnancy or modifiable factors. METHODS: Pregnancies who stopped fingolimod treatment within 1 year before or during pregnancy were identified from the German MS and Pregnancy Registry. Data were collected through structured telephone-administered questionnaires and neurologists' notes. Severe relapses were defined as a ≥2.0 increase in Expanded Disability Status Scale (EDSS) or new or worsening relapse-related ambulatory impairment. Women who continued to meet this definition 1 year postpartum were classified as reaching the Severe Relapse Disability Composite Score (SRDCS). Multivariable models accounting for measures of disease severity and repeated events were used. RESULTS: Of the 213 pregnancies among 201 women (mean age at pregnancy onset 32 years) identified, 56.81% (n = 121) discontinued fingolimod after conception. Relapses during pregnancy (31.46%) and the postpartum year (44.60%) were common. Nine pregnancies had a severe relapse during pregnancy and additional 3 during the postpartum year. One year postpartum, 11 of these (6.32% of n = 174 with complete EDSS information) reached the SRDCS. Adjusted relapse rates during pregnancy were slightly higher compared with the year before pregnancy (relapse rate ratio = 1.24, 95% CI 0.91-1.68). Neither exclusive breastfeeding nor resuming fingolimod within 4 weeks of delivery were associated with a reduced risk of postpartum relapses. Most pregnancies relapsed during the first 3 months postpartum (n = 55/204, 26.96%). DISCUSSION: Relapses during pregnancy after fingolimod cessation are common. Approximately 6% of women will retain clinically meaningful disability from these pregnancy-related, fingolimod cessation relapses 1 year postpartum. This information should be shared with women on fingolimod desiring pregnancy, and optimizing MS treatment with nonteratogenic approaches should be discussed.
Assuntos
Esclerose Múltipla , Gravidez , Feminino , Humanos , Adulto , Esclerose Múltipla/tratamento farmacológico , Cloridrato de Fingolimode/efeitos adversos , Período Pós-Parto , Recidiva , Sistema de RegistrosRESUMO
BACKGROUND: Cancer-related fatigue (CRF) is defined as a "distressing, persistent, subjective sense of physical, emotional, and/or cognitive tiredness or exhaustion related to cancer or cancer treatment that is not proportional to recent activity and interferes with usual functioning." CRF is frequently observed in cancer patients even before the initiation of tumor therapy. Its cause is not clear, but in addition to primary effects of therapy, a tumor-induced elevated level of inflammatory cytokines may play a role. Transcutaneous auricular vagal nerve stimulation (taVNS) is a noninvasive way to activate central nervous pathways and modulate pain perception and the immune system. It has positive effects on autoimmune conditions and can also improve fatigue associated with Sjogren's syndrome. It is the main purpose of this feasibility study to investigate the feasibility of daily taVNS against CRF. Therefore, the stimulation protocol of the newly introduced smartphone app of the manufacturer is evaluated. Additionally, the effect taVNS on CRF and quality of life (QoL) shall be evaluated. METHODS: Thirty adult patients with gastrointestinal tumors during or after treatment, relevant CRF (Hornheide questionnaire) and life expectancy > 1 year, are enrolled. Patients are randomized to treatment or sham arm and be informed that they will either feel the stimulation or not. Treatment group will receive left-sided tragus above-threshold stimulation with 25 Hz, 250 µs pulse width, and 28-s/32-s on/off paradigm for 4 h throughout the day for 4 weeks. Sham group will receive no stimulation via a nonfunctional electrode. A daily stimulation protocol with time and average intensity is automatically created by a smartphone app connected to the stimulator via Bluetooth®. Multidimensional Fatigue Inventory-20, Short-Form 36 and Beck Depression Inventory questionnaires will be filled out before and after 4 weeks of stimulation. DISCUSSION: Primarily, the patients' daily stimulation time and intensity will be evaluated through the electronic protocol after 4 weeks. Secondarily, the effect of taVNS on cancer-related fatigue and QoL will be measured through the questionnaires. As taVNS seems to modulate inflammatory cytokines, this noninvasive method may - if accepted by the patients - be a promising adjunct in the treatment of cancer-related fatigue. TRIAL REGISTRATION: The study was approved by local ethics committee (21-7395) and registered at the DRKS database (DRKS00027481).