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Validation of standard operating procedures in a multicenter retrospective study to identify -omics biomarkers for chronic low back pain.

ABSTRACT: Chronic low back pain (CLBP) is one of the most common medical conditions, ranking as the greatest contributor to global disability and accounting for huge societal costs based on the Global Burden of Disease 2010 study. Large genetic and -omics studies provide a promising avenue for the screening, development and validation of biomarkers useful for personalized diagnosis and treatment (precision medicine). Multicentre studies are needed for such an effort, and a standardized and homogeneous approach is vital for recruitment of large numbers of participants among different centres (clinical and laboratories) to obtain robust and reproducible results. To date, no validated standard operating procedures (SOPs) for genetic/-omics studies in chronic pain have been developed. In this study, we validated an SOP model that will be used in the multicentre (5 centres) retrospective "PainOmics" study, funded by the European Community in the 7th Framework Programme, which aims to develop new biomarkers for CLBP through three different -omics approaches: genomics, glycomics and activomics. The SOPs describe the specific procedures for (1) blood collection, (2) sample processing and storage, (3) shipping details and (4) cross-check testing and validation before assays that all the centres involved in the study have to follow. Multivariate analysis revealed the absolute specificity and homogeneity of the samples collected by the five centres for all genetics, glycomics and activomics analyses. The SOPs used in our multicenter study have been validated. Hence, they could represent an innovative tool for the correct management and collection of reliable samples in other large-omics-based multicenter studies.

SUBMITTER: Dagostino C

PROVIDER: S-EPMC5411039 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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Validation of standard operating procedures in a multicenter retrospective study to identify -omics biomarkers for chronic low back pain.

Dagostino Concetta C De Gregori Manuela M Gieger Christian C Manz Judith J Gudelj Ivan I Lauc Gordan G Divizia Laura L Wang Wei W Sim Moira M Pemberton Iain K IK MacDougall Jane J Williams Frances F Van Zundert Jan J Primorac Dragan D Aulchenko Yurii Y Kapural Leonardo L Allegri Massimo M

PloS one 20170501 5

Chronic low back pain (CLBP) is one of the most common medical conditions, ranking as the greatest contributor to global disability and accounting for huge societal costs based on the Global Burden of Disease 2010 study. Large genetic and -omics studies provide a promising avenue for the screening, development and validation of biomarkers useful for personalized diagnosis and treatment (precision medicine). Multicentre studies are needed for such an effort, and a standardized and homogeneous app ...[more]

PMID: 28459826

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Project description:IntroductionChronic low back pain (CLBP) produces considerable direct costs as well as indirect burdens for society, industry and health systems. CLBP is characterised by heterogeneity, inclusion of several pain syndromes, different underlying molecular pathologies and interaction with psychosocial factors that leads to a range of clinical manifestations. There is still much to understand in the underlying pathological processes and the non-psychosocial factors which account for differences in outcomes. Biomarkers that may be objectively used for diagnosis and personalised, targeted and cost-effective treatment are still lacking. Therefore, any data that may be obtained at the '-omics' level (glycomics, Activomics and genome-wide association studies-GWAS) may be helpful to use as dynamic biomarkers for elucidating CLBP pathogenesis and may ultimately provide prognostic information too. By means of a retrospective, observational, case-cohort, multicentre study, we aim to investigate new promising biomarkers potentially able to solve some of the issues related to CLBP.Methods and analysisThe study follows a two-phase, 1:2 case-control model. A total of 12 000 individuals (4000 cases and 8000 controls) will be enrolled; clinical data will be registered, with particular attention to pain characteristics and outcomes of pain treatments. Blood samples will be collected to perform -omics studies. The primary objective is to recognise genetic variants associated with CLBP; secondary objectives are to study glycomics and Activomics profiles associated with CLBP.Ethics and disseminationThe study is part of the PainOMICS project funded by European Community in the Seventh Framework Programme. The study has been approved from competent ethical bodies and copies of approvals were provided to the European Commission before starting the study. Results of the study will be reviewed by the Scientific Board and Ethical Committee of the PainOMICS Consortium. The scientific results will be disseminated through peer-reviewed journals.Trial registration numberNCT02037789; Pre-results.

Project description:BackgroundInterventions for insomnia that also address autonomic dysfunction are needed.ObjectiveWe evaluate Cereset Research™ Standard Operating Procedures (CR-SOP) in a pilot randomized, controlled trial. CR-SOP is a less operator-dependent, more generalizable innovation of HIRREM®, a noninvasive, closed-loop, allostatic, acoustic stimulation neurotechnology demonstrated to improve insomnia and autonomic function.MethodsAdults with Insomnia Severity Index (ISI) scores of ≥8 were randomized to receive ten sessions of CR-SOP, with tones linked to brainwaves (LB, intervention), or a sham condition of random tones not linked to brainwaves (NL, control). Measures were collected at enrollment and 0-14 days and 4-6 weeks post-allocated intervention. The primary outcome was differential change in ISI from baseline to 4-6 weeks post-intervention. Secondary self-report measures assessed sleep quality65 and behavioral outcomes. Ten-minute recordings of heart rate and blood pressure were collected to analyze autonomic function (heart rate variability [HRV] and baroreflex sensitivity).ResultsOf 22 randomized, 20 participants completed the allocated condition. Intention to treat analysis of change from baseline to the 4-6 week outcome demonstrated mean ISI score reduction of 4.69 points among controls (SE 1.40). In the intervention group, there was an additional 2.58 point reduction in ISI score (SE 2.13; total reduction of 7.27, P = .24). Sleep quality and some measures of autonomic function improved significantly among the intervention group compared to control.ConclusionsThis pilot study compared use of a standardized, allostatic, acoustic neurotechnology intervention with a sham, active control condition. The magnitude of change in insomnia severity was clinically relevant and similar to the findings in a prior, fully powered trial, but the differential improvement observed was not statistically significant. Significant improvements were demonstrated in sleep quality and some autonomic function measures.

Project description:BackgroundPain-related self-efficacy is defined as the beliefs held by people with chronic pain that certain activities can be carried out despite the pain. Poor self-efficacy is an obstacle to the recovery and predicts long-term disability. The aims of this study are to investigate the prevalence of poor pain self-efficacy in Italian subjects with chronic low back pain (LBP), and to inquire the relationships between self-efficacy, disability, pain, and main demographic and clinical characteristics.MethodsA secondary multicenter retrospective analysis was done on 310 outpatients with chronic non-specific LBP. The pain self-efficacy measured with the Pain Self-Efficacy Questionnaire (PSEQ), the disability measured with the Roland & Morris Disability Questionnaire, and the pain intensity measured with the Numerical Rating Scale were considered variables to investigate, whereas demographic and clinical variables were considered predictors or potential confounders. A 40/60 PSEQ score was adopted as cut-off to distinguish between good and poor self-efficacy.Results199 subjects (64.2% of the sample) showed poor self-efficacy. The odds of having poor self-efficacy appeared significantly related to female gender (OR = 1.80, 95%CI [1.12;2.90]; p = 0.015) and drugs use (OR = 1.68, 95%CI [1.06;2.70]; p = 0.029). Significant relationships also emerged between disability and higher age (β = 0.07, 95%CI [0.01; 0.12]; p = 0.02), being female (β = 1.80, 95%CI [0.32;3.29]; p = 0.018), low educational level (β = - 1.68, 95%CI [- 2.59;-3.29]; p < 0.001), higher height (β = - 0.08, 95%CI [- 0.158;-0.002]; p = 0.045), pain duration [mos] (β = 0.01, 95%CI [0.001;0.021]; p = 0.041), and drugs use (β = 2.86, 95%CI [1.44;4.27]; p < 0.001). The amount of pain appeared significantly related to educational level (β = - 0.47, 95%CI [- 0.76;-0.182]; p < 0.001), smoking (β = 0.56, 95%CI [0.09; 1.03]; p = 0.021), height (β = - 0.03, 95%CI [- 0.05; - 0.002]; p = 0.036), and drugs use (β = 0.81, 95%CI [0.399;1.22]; p < 0.001). No significant correlation appeared among weight, body mass index, and referred pain neither in relation to self-efficacy, nor in relation to pain/disability.ConclusionsThe majority of our sample, composed of Italian people complained of chronic LBP, shows poor self-efficacy. Female gender and drugs use are significantly related to poor self-efficacy, low educational level negatively influences the amount of perceived pain and disability, and older age and smoking are related to disability and pain intensity, respectively. The knowledge of these sociodemographic and clinical characteristics potentially influencing chronic LBP may be useful to address more efforts towards the most negatively impacted subjects, among the entire population complained of chronic LBP.

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Validation of standard operating procedures in a multicenter retrospective study to identify -omics biomarkers for chronic low back pain.

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Validation of standard operating procedures in a multicenter retrospective study to identify -omics biomarkers for chronic low back pain.

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