Dataset Information

Treatment-associated network dynamics in patients with globus sensations: a proof-of-concept study.

ABSTRACT: In this proof-of-concept study, we used a systems perspective to conceptualize and investigate treatment-related dynamics (temporal and cross-sectional associations) of symptoms and elements related to the manifestation of a common functional somatic syndrome (FSS), Globus Sensations (GS). We analyzed data from 100 patients (M = 47.1 years, SD = 14.4 years; 64% female) with GS who received eight sessions of group psychotherapy in the context of a randomized controlled trial (RCT). Symptoms and elements were assessed after each treatment session. We applied a multilevel graphical vector-autoregression (ml GVAR) model approach resulting in three separate, complementary networks (temporal, contemporaneous, and between-subject) for an affective, cognitive, and behavioral dimension, respectively. GS were not temporally associated with any affective, cognitive, and behavioral elements. Temporally, catastrophizing cognitions predicted bodily weakness (r = 0.14, p < 0.01, 95% confidence interval (CI) [0.04-0.23]) and GS predicted somatic distress (r = 0.18, p < 0.05, 95% CI [0.04-0.33]). Potential causal pathways between catastrophizing cognitions and bodily weakness as well as GS and somatic distress may reflect treatment-related temporal change processes in patients with GS. Our study illustrates how dynamic NA can be used in the context of outcome research.

SUBMITTER: Imperiale MN

PROVIDER: S-EPMC10511470 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature

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Treatment-associated network dynamics in patients with globus sensations: a proof-of-concept study.

Imperiale Marina N MN Lieb Roselind R Meinlschmidt Gunther G

Scientific reports 20230920 1

In this proof-of-concept study, we used a systems perspective to conceptualize and investigate treatment-related dynamics (temporal and cross-sectional associations) of symptoms and elements related to the manifestation of a common functional somatic syndrome (FSS), Globus Sensations (GS). We analyzed data from 100 patients (M = 47.1 years, SD = 14.4 years; 64% female) with GS who received eight sessions of group psychotherapy in the context of a randomized controlled trial (RCT). Symptoms and e ...[more]

PMID: 37730963

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Project description:BackgroundNetwork meta-analysis (NMA) simultaneously synthesises direct and indirect evidence on the relative efficacy and safety of at least three treatments. A decision maker may use the coherent results of an NMA to determine which treatment is best for a given outcome. However, this evidence must be balanced across multiple outcomes. This study aims to provide a framework that permits the objective integration of the comparative effectiveness and safety of treatments across multiple outcomes.MethodsIn the proposed framework, measures of each treatment's performance are plotted on its own pie chart, superimposed on another pie chart representing the performance of a hypothetical treatment that is the best across all outcomes. This creates a spie chart for each treatment, where the coverage area represents the probability a treatment ranks best overall. The angles of each sector may be adjusted to reflect the importance of each outcome to a decision maker. The framework is illustrated using two published NMA datasets comparing dietary oils and fats and psoriasis treatments. Outcome measures are plotted in terms of the surface under the cumulative ranking curve. The use of the spie chart was contrasted with that of the radar plot.ResultsIn the NMA comparing the effects of dietary oils and fats on four lipid biomarkers, the ease of incorporating the lipids' relative importance on spie charts was demonstrated using coefficients from a published risk prediction model on coronary heart disease. Radar plots produced two sets of areas based on the ordering of the lipids on the axes, while the spie chart only produced one set. In the NMA comparing psoriasis treatments, the areas inside spie charts containing both efficacy and safety outcomes masked critical information on the treatments' comparative safety. Plotting the areas inside spie charts of the efficacy outcomes against measures of the safety outcome facilitated simultaneous comparisons of the treatments' benefits and harms.ConclusionsThe spie chart is more optimal than a radar plot for integrating the comparative effectiveness or safety of a treatment across multiple outcomes. Formal validation in the decision-making context, along with statistical comparisons with other recent approaches are required.

Project description:Patients with HTLV-1-associated myelopathy/tropical spastic paraparesis (HAM/TSP) become progressively impaired, with chronic pain, immobility and bladder, bowel and sexual dysfunction. Tested antiretroviral therapies have not been effective and most patients are offered a short course of corticosteroids or interferon-?, physiotherapy and symptomatic management. Pathogenesis studies implicate activated T-lymphocytes and cytokines in tissue damage. We therefore tested the hypothesis that inhibition of T-cell activation with ciclosporin A would be safe and clinically beneficial in patients with early and/or clinically progressing HAM/TSP.Open label, proof of concept, pilot study of 48 weeks therapy with the calcineurin antagonist, ciclosporin A (CsA), in seven patients with 'early' (<two years) or 'progressive' (>50% deterioration in timed walk during the preceding three months) HAM/TSP. Primary outcomes were incidence of clinical failure at 48 weeks and time to clinical failure.All patients completed 72 weeks study participation and five showed objective evidence of clinical improvement after 3 months treatment with CsA. Two patients exhibited clinical failure over 6.4 person-years of follow-up to week 48. One patient had a >2 point deterioration in IPEC (Insituto de Pesquisa Clinica Evandro Chagas) disability score at weeks 8 and 12, and then stopped treatment. The other stopped treatment at week 4 because of headache and tremor and deterioration in timed walk, which occurred at week 45. Overall pain, mobility, spasticity and bladder function improved by 48 weeks. Two patients recommenced CsA during follow-up due to relapse.These data provide initial evidence that treatment with CsA is safe and may partially reverse the clinical deterioration seen in patients with early/progressive HAM/TSP. This trial supports further investigation of this agent's safety and effectiveness in larger, randomised controlled studies in carefully selected patients with disease progression.

Dataset Information

Treatment-associated network dynamics in patients with globus sensations: a proof-of-concept study.

Publications

Treatment-associated network dynamics in patients with globus sensations: a proof-of-concept study.

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