1,955 research outputs found
Effectiveness and cost-effectiveness of treatment with additional enrollment to a homeopathic integrated care contract in Germany
Background:
A number of German statutory health insurance companies are offering integrated care contracts for homeopathy (ICCHs) that cover the reimbursement of homeopathic treatment. The effectiveness and cost-effectiveness of these contracts are highly debated.
Methods:
To evaluate the effectiveness and cost-effectiveness of treatment after an additional enrollment in an ICCH, a comparative, prospective, observational study was conducted in which participants in the ICCH (HOM group) were compared with matched (on diagnosis, sex and age) insured individuals (CON group) who received usual care alone.
Those insured with either migraine or headache, allergic rhinitis, asthma, atopic dermatitis and depression were included. Primary effectiveness outcomes were the baseline adjusted scores of diagnosis-specific questionnaires (e.g. RQLQ, AQLQ, DLQI, BDI-II) after 6 months. Primary cost-effectiveness endpoints were the baseline adjusted total costs from an insurer perspective in relation to the achieved quality-adjusted life years (QALYs). Costs were derived from health claims data and QALYs were calculated based on SF-12 data.
Results:
Data from 2524 participants (1543 HOM group) were analyzed. The primary effectiveness outcomes after six months were statistically significant in favor of the HOM group for migraine or headache (Δ = difference between groups, days with headache: − 0.9, p = 0.042), asthma (Δ-AQLQ(S): + 0.4, p = 0.014), atopic dermatitis (Δ-DLQI: − 5.6, p ≤ 0.001) and depression (Δ-BDI-II: − 5.6, p ≤ 0.001). BDI-II differences reached the minimal clinically important difference. For all diagnoses, the adjusted mean total costs over 12 months were higher in the HOM group from an insurer perspective, with migraine or headache, atopic dermatitis and depression suggesting cost-effectiveness in terms of additional costs per QALY gained.
Conclusion:
After an additional enrollment in the ICCH, the treatment of participants with depression showed minimally clinically relevant improvements. From an insurer perspective, treatment with an ICCH enrollment resulted in higher costs over all diagnoses but seemed to be cost-effective for migraine or headache, atopic dermatitis and depression according to international used threshold values. Based on the study design and further limitations, our findings should be considered cautiously and no conclusions regarding the effectiveness of specific treatment components can be made. Further research is needed to overcome limitations of this study and to confirm our findings.
Trial registration:
clinicaltrials.gov, NCT01854580. Registered 15 March 2013 – Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT0185458
The effect of osteopathic medicine on pain in musicians with nonspecific chronic neck pain: a randomized controlled trial
Background: Nonspecific chronic neck pain (cNP) is common in adult violinists and violists
and is often treated with osteopathic medicine (OM), although the effectiveness of this
treatment has not been determined to date. This study aimed to evaluate the effectiveness and
safety of OM in adult violinists and violists with cNP.
Methods: In a two-armed randomized controlled single-center open trial, adult violinists
and violists, including music students, with cNP (⩾12 weeks) were randomized to either
five individualized OM sessions (OM group) or to no intervention (control group, CG) in the
outpatient clinic for integrative medicine, Charité - Universitätsmedizin Berlin, Germany.
All patients received a musicians’ medicine consultation and paracetamol on demand. The
primary outcome parameter was the neck pain intensity on a visual analog scale (VAS, 0–
100 mm, 0 = no pain, 100 = worst imaginable pain) after 12 weeks. Secondary outcomes included
neck pain disability (Neck Disability Index, NDI, 0–100%) after 12 weeks. The last follow-up visit
was after 52 weeks. Statistical analysis included analysis of covariance adjusted for respective
baseline value.
Results: Altogether, 62 outpatients were included [OM group (n = 28), CG (n = 34); 81% female;
mean age, 41.6 ± 11.1 years; mean baseline neck pain, 55.9 ± 11.6 mm]. After 12 weeks, OM
was associated with an improvement in the OM group versus the CG in neck pain on the VAS
[14.6 mm (95% confidence interval 8.0; 21.2) versus 40.8 mm (34.7; 46.9), p < 0.001, Cohen’s
d = 1.4], and neck pain disability as determined by the NDI [8.8% (6.7; 10.8) versus 17.2% (15.3;
19.1), p < 0.001]. Some improvements were maintained until 52 weeks of follow-up. No serious
adverse events were observed.
Conclusions: The results of this study suggest that OM might be effective in reducing
pain intensity in adult violinists and violists with nonspecific cNP. Further studies should
investigate the efficacy of OM in comparison with a sham procedure and with other effective
therapy methods in high-quality multicenter trials.
Trial registration: WHO Trial Registration
https://apps.who.int/trialsearch/NoAccess.aspx?aspxerrorpath=/trialsearch/Trial2.aspx by
German Clinical Trials Register DRKS00009258, Universal Trial Number (UTN): U1111-1173-
5943
Utilization and costs of health care and early support services in Germany and the influence of mental health burden during the postnatal period
Limited evidence is available about health care utilization and its determinants in the vulnerable postnatal period for
mothers and their children. Thus, the aim of our analyses was to assess determinants of health care and early support
services utilization regarding mothers and their children and associated costs in the postnatal period in Germany.
Moreover, we aimed to investigate the impact of noticeable mental health and psychosocial burdens on health care
and early support services utilization and costs. Using a two-step assessment process of parents from a randomly
selected sample of 30,000 recently born children in the multicenter observational population-based cohort study of
the SKKIPPI project, we firstly identified mothers who were potentially at risk of mental health and psychosocial
burden. These mothers were then invited to participate in an in-depth assessment, including a detailed self-developed
questionnaire focusing on early support and health care services utilization. A follow-up after 6 months was conducted.
Potential determinants of early support services utilization were analyzed using logistic regression. General
linear models with gamma distribution and log link functions were applied to analyze potential determinants of health
care costs and to estimate mean adjusted costs. Mothers with a noticeable mental health or psychosocial burden and
their children caused mean early support services costs of €1073 and caused total costs of €10,849 in the postnatal
period from a payer’s perspective compared to €349 (early support services) and €9136 (total costs) for mothers
without a noticeable mental health or psychosocial burden and their children. The main determinants of total costs
were facing a chronic disease (child), preterm delivery, bad experiences with doctors and midwives, and single
parenthood. The majority of participants (69 %) utilized some kind of early support services. The most important
determinants of early support service utilization in the postnatal period with respect to the children were facing a
chronic disease, being the first child, and being born as a twin. Our findings highlight the importance of sufficient
appreciation and treatment of mental health problems in the postnatal period from both a societal and payer’s
perspective. Future research should investigate whether these and more specific interventions could be a costeffective
way to support mothers with mental health or psychosocial burden and their children
The geometry of nonlinear least squares with applications to sloppy models and optimization
Parameter estimation by nonlinear least squares minimization is a common
problem with an elegant geometric interpretation: the possible parameter values
of a model induce a manifold in the space of data predictions. The minimization
problem is then to find the point on the manifold closest to the data. We show
that the model manifolds of a large class of models, known as sloppy models,
have many universal features; they are characterized by a geometric series of
widths, extrinsic curvatures, and parameter-effects curvatures. A number of
common difficulties in optimizing least squares problems are due to this common
structure. First, algorithms tend to run into the boundaries of the model
manifold, causing parameters to diverge or become unphysical. We introduce the
model graph as an extension of the model manifold to remedy this problem. We
argue that appropriate priors can remove the boundaries and improve convergence
rates. We show that typical fits will have many evaporated parameters. Second,
bare model parameters are usually ill-suited to describing model behavior; cost
contours in parameter space tend to form hierarchies of plateaus and canyons.
Geometrically, we understand this inconvenient parametrization as an extremely
skewed coordinate basis and show that it induces a large parameter-effects
curvature on the manifold. Using coordinates based on geodesic motion, these
narrow canyons are transformed in many cases into a single quadratic, isotropic
basin. We interpret the modified Gauss-Newton and Levenberg-Marquardt fitting
algorithms as an Euler approximation to geodesic motion in these natural
coordinates on the model manifold and the model graph respectively. By adding a
geodesic acceleration adjustment to these algorithms, we alleviate the
difficulties from parameter-effects curvature, improving both efficiency and
success rates at finding good fits.Comment: 40 pages, 29 Figure
Clinical Trials and Medical Care: Defining the Therapeutic Misconception
A key component of informed consent to participate in medical research includes understanding that research is not the same as treatment
Defining the clonal dynamics leading to mouse skin tumour initiation.
The changes in cell dynamics after oncogenic mutation that lead to the development of tumours are currently unknown. Here, using skin epidermis as a model, we assessed the effect of oncogenic hedgehog signalling in distinct cell populations and their capacity to induce basal cell carcinoma, the most frequent cancer in humans. We found that only stem cells, and not progenitors, initiated tumour formation upon oncogenic hedgehog signalling. This difference was due to the hierarchical organization of tumour growth in oncogene-targeted stem cells, characterized by an increase in symmetric self-renewing divisions and a higher p53-dependent resistance to apoptosis, leading to rapid clonal expansion and progression into invasive tumours. Our work reveals that the capacity of oncogene-targeted cells to induce tumour formation is dependent not only on their long-term survival and expansion, but also on the specific clonal dynamics of the cancer cell of origin.C.B. is an investigator of WELBIO. A.S-D. and JC.L. are supported by a fellowship of the FNRS and FRIA respectively. B.D.S. and E.H. are supported by the Wellcome Trust (grant number 098357/Z/12/Z and 110326/Z/15/Z). EH is supported by a fellowship from Trinity College, Cambridge. This work was supported by the FNRS, the IUAP program, the Fondation contre le Cancer, the ULB fondation, the foundation Bettencourt Schueller, the foundation Baillet Latour, a consolidator grant of the European Research Council.This is the author accepted manuscript. The final version is available from Nature Publishing Group via http://dx.doi.org/10.1038/nature1906
Estimating the evidence of selection and the reliability of inference in unigenic evolution
<p>Abstract</p> <p>Background</p> <p>Unigenic evolution is a large-scale mutagenesis experiment used to identify residues that are potentially important for protein function. Both currently-used methods for the analysis of unigenic evolution data analyze 'windows' of contiguous sites, a strategy that increases statistical power but incorrectly assumes that functionally-critical sites are contiguous. In addition, both methods require the questionable assumption of asymptotically-large sample size due to the presumption of approximate normality.</p> <p>Results</p> <p>We develop a novel approach, termed the Evidence of Selection (EoS), removing the assumption that functionally important sites are adjacent in sequence and and explicitly modelling the effects of limited sample-size. Precise statistical derivations show that the EoS score can be easily interpreted as an expected log-odds-ratio between two competing hypotheses, namely, the hypothetical presence or absence of functional selection for a given site. Using the EoS score, we then develop selection criteria by which functionally-important yet non-adjacent sites can be identified. An approximate power analysis is also developed to estimate the reliability of inference given the data. We validate and demonstrate the the practical utility of our method by analysis of the homing endonuclease <monospace>I-Bmol</monospace>, comparing our predictions with the results of existing methods.</p> <p>Conclusions</p> <p>Our method is able to assess both the evidence of selection at individual amino acid sites and estimate the reliability of those inferences. Experimental validation with <monospace>I-Bmol</monospace> proves its utility to identify functionally-important residues of poorly characterized proteins, demonstrating increased sensitivity over previous methods without loss of specificity. With the ability to guide the selection of precise experimental mutagenesis conditions, our method helps make unigenic analysis a more broadly applicable technique with which to probe protein function.</p> <p>Availability</p> <p>Software to compute, plot, and summarize EoS data is available as an open-source package called 'unigenic' for the 'R' programming language at <url>http://www.fernandes.org/txp/article/13/an-analytical-framework-for-unigenic-evolution</url>.</p
Jet energy measurement with the ATLAS detector in proton-proton collisions at root s=7 TeV
The jet energy scale and its systematic uncertainty are determined for jets measured with the ATLAS detector at the LHC in proton-proton collision data at a centre-of-mass energy of √s = 7TeV corresponding to an integrated luminosity of 38 pb-1. Jets are reconstructed with the anti-kt algorithm with distance parameters R=0. 4 or R=0. 6. Jet energy and angle corrections are determined from Monte Carlo simulations to calibrate jets with transverse momenta pT≥20 GeV and pseudorapidities {pipe}η{pipe}<4. 5. The jet energy systematic uncertainty is estimated using the single isolated hadron response measured in situ and in test-beams, exploiting the transverse momentum balance between central and forward jets in events with dijet topologies and studying systematic variations in Monte Carlo simulations. The jet energy uncertainty is less than 2. 5 % in the central calorimeter region ({pipe}η{pipe}<0. 8) for jets with 60≤pT<800 GeV, and is maximally 14 % for pT<30 GeV in the most forward region 3. 2≤{pipe}η{pipe}<4. 5. The jet energy is validated for jet transverse momenta up to 1 TeV to the level of a few percent using several in situ techniques by comparing a well-known reference such as the recoiling photon pT, the sum of the transverse momenta of tracks associated to the jet, or a system of low-pT jets recoiling against a high-pT jet. More sophisticated jet calibration schemes are presented based on calorimeter cell energy density weighting or hadronic properties of jets, aiming for an improved jet energy resolution and a reduced flavour dependence of the jet response. The systematic uncertainty of the jet energy determined from a combination of in situ techniques is consistent with the one derived from single hadron response measurements over a wide kinematic range. The nominal corrections and uncertainties are derived for isolated jets in an inclusive sample of high-pT jets. Special cases such as event topologies with close-by jets, or selections of samples with an enhanced content of jets originating from light quarks, heavy quarks or gluons are also discussed and the corresponding uncertainties are determined. © 2013 CERN for the benefit of the ATLAS collaboration
Measurement of the inclusive and dijet cross-sections of b-jets in pp collisions at sqrt(s) = 7 TeV with the ATLAS detector
The inclusive and dijet production cross-sections have been measured for jets
containing b-hadrons (b-jets) in proton-proton collisions at a centre-of-mass
energy of sqrt(s) = 7 TeV, using the ATLAS detector at the LHC. The
measurements use data corresponding to an integrated luminosity of 34 pb^-1.
The b-jets are identified using either a lifetime-based method, where secondary
decay vertices of b-hadrons in jets are reconstructed using information from
the tracking detectors, or a muon-based method where the presence of a muon is
used to identify semileptonic decays of b-hadrons inside jets. The inclusive
b-jet cross-section is measured as a function of transverse momentum in the
range 20 < pT < 400 GeV and rapidity in the range |y| < 2.1. The bbbar-dijet
cross-section is measured as a function of the dijet invariant mass in the
range 110 < m_jj < 760 GeV, the azimuthal angle difference between the two jets
and the angular variable chi in two dijet mass regions. The results are
compared with next-to-leading-order QCD predictions. Good agreement is observed
between the measured cross-sections and the predictions obtained using POWHEG +
Pythia. MC@NLO + Herwig shows good agreement with the measured bbbar-dijet
cross-section. However, it does not reproduce the measured inclusive
cross-section well, particularly for central b-jets with large transverse
momenta.Comment: 10 pages plus author list (21 pages total), 8 figures, 1 table, final
version published in European Physical Journal
Measurement of the cross-section and charge asymmetry of bosons produced in proton-proton collisions at TeV with the ATLAS detector
This paper presents measurements of the and cross-sections and the associated charge asymmetry as a
function of the absolute pseudorapidity of the decay muon. The data were
collected in proton--proton collisions at a centre-of-mass energy of 8 TeV with
the ATLAS experiment at the LHC and correspond to a total integrated luminosity
of 20.2~\mbox{fb^{-1}}. The precision of the cross-section measurements
varies between 0.8% to 1.5% as a function of the pseudorapidity, excluding the
1.9% uncertainty on the integrated luminosity. The charge asymmetry is measured
with an uncertainty between 0.002 and 0.003. The results are compared with
predictions based on next-to-next-to-leading-order calculations with various
parton distribution functions and have the sensitivity to discriminate between
them.Comment: 38 pages in total, author list starting page 22, 5 figures, 4 tables,
submitted to EPJC. All figures including auxiliary figures are available at
https://atlas.web.cern.ch/Atlas/GROUPS/PHYSICS/PAPERS/STDM-2017-13
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