How to Investigate Within-Subject Associations between Physical Activity and Momentary Affective States in Everyday Life: A Position Statement Based on a Literature Overview

Several meta-analyses have investigated the association between physical activity and affective states and have found evidence suggesting that exercise exerts a positive effect on affective state. However, in this field of research, most studies have conducted between-subject analyses. Nonetheless, there is more and more interest in the within-subject associations between physical activity and momentary affective states in everyday life. This position statement pertains to this up-and-coming field of research and provides methodological recommendations for further studies. The paper is divided into three parts:First, we summarise and evaluate three methodological requirements necessary for the proper evaluation of within-subject associations between physical activity and momentary affective states in everyday life. We propose that the following issues should be considered: a) to address the dynamic nature of such relationships, repeated assessments are necessary; b) as activities performed in everyday life are mostly spontaneous and unconscious, an objective assessment of physical activity is useful; c) given that recall of affective states is often affected by systematic distortions, real-time assessment is preferable. In sum, we suggest the use of ambulatory assessment techniques, and more specifically the combination of acceloremeter-assessment of physical activity with an electronic diary assessment of the momentary affective state and additional context information. Second, we summarise 22 empirical studies published between 1980 and 2012 using ambulatory assessment to investigate within-subject associations between momentary affective states and physical activity in everyday life. Generally, the literature overview detects a positive association, which appears stronger among those studies that were of high methodological quality.Third, we propose the use of ambulatory assessment intervention strategies to change people's behaviour (ambulatory assessment in

Identification and Characterization of Human Observational Studies in Nutritional Epidemiology on Gut Microbiomics for Joint Data Analysis

In any research field, data access and data integration are major challenges that even large, well-established consortia face. Although data sharing initiatives are increasing, joint data analyses on nutrition and microbiomics in health and disease are still scarce. We aimed to identify observational studies with data on nutrition and gut microbiome composition from the Intestinal Microbiomics (INTIMIC) Knowledge Platform following the findable, accessible, interoperable, and reusable (FAIR) principles. An adapted template from the European Nutritional Phenotype Assessment and Data Sharing Initiative (ENPADASI) consortium was used to collect microbiome-specific information and other related factors. In total, 23 studies (17 longitudinal and 6 cross-sectional) were identified from Italy (7), Germany (6), Netherlands (3), Spain (2), Belgium (1), and France (1) or multiple countries (3). Of these, 21 studies collected information on both dietary intake (24 h dietary recall, food frequency questionnaire (FFQ), or Food Records) and gut microbiome. All studies collected stool samples. The most often used sequencing platform was Illumina MiSeq, and the preferred hypervariable regions of the 16S rRNA gene were V3-V4 or V4. The combination of datasets will allow for sufficiently powered investigations to increase the knowledge and understanding of the relationship between food and gut microbiome in health and disease

Genome-wide association study of primary sclerosing cholangitis identifies new risk loci and quantifies the genetic relationship with inflammatory bowel disease.

Primary sclerosing cholangitis (PSC) is a rare progressive disorder leading to bile duct destruction; ∼75% of patients have comorbid inflammatory bowel disease (IBD). We undertook the largest genome-wide association study of PSC (4,796 cases and 19,955 population controls) and identified four new genome-wide significant loci. The most associated SNP at one locus affects splicing and expression of UBASH3A, with the protective allele (C) predicted to cause nonstop-mediated mRNA decay and lower expression of UBASH3A. Further analyses based on common variants suggested that the genome-wide genetic correlation (rG) between PSC and ulcerative colitis (UC) (rG = 0.29) was significantly greater than that between PSC and Crohn's disease (CD) (rG = 0.04) (P = 2.55 × 10-15). UC and CD were genetically more similar to each other (rG = 0.56) than either was to PSC (P < 1.0 × 10-15). Our study represents a substantial advance in understanding of the genetics of PSC

Managerial framework for a large multi-centre clinical trial within an EU-funded collaborative project – The “PREVIEW” case study

A multi-centre clinical trial involves the implementation of the same clinical protocol at several independent investigational centres. Multi-centre clinical trials may be preferable to single-centre trials, but their implementation and management is more complex. EU-funded collaborative projects involve several participating organizations and countries and their consortia are typically multidisciplinary. Their coordination requires a joint effort from several actors, and an appropriate managerial structure and procedures need to be defined and established. The management of the Framework Programme 7 (FP7) PREVIEW project, whose core consisted of a clinical trial with 8 intervention centres/sites is presented as case study. PREVIEW was coordinated by the University of Copenhagen. The project management was implemented by a combination of decentralised project management, at the department level, jointly by the Project Coordinator (PC) and Project Manager (PM), and centralised, by a dedicated EU Liaison Officer from the Project Management Office (PMO). The Quality Manager role was undertaken by the PC, with support from selected consortium members. The Exploitation Manager role was assumed by the leader of the dissemination and exploitation work package. The Data Manager (DM) at the University of Copenhagen established and maintained a datahub for all data from the clinical trial. The General Assembly and Steering Committee were key decision bodies with regard to taking and implementing decisions. The Scientific Advisory Board (SAB) was formed by reputed external experts providing guidance and advice. The project website was the main channel to reach the general public. A password protected private section was used as internal repository for the project. Regular meetings at all levels were key to ensure good communication and collaboration among the project team. Appropriate attention to data management was given from the start. The privacy of personal data was ensured in accordance with national and EU regulations. The PC was also the Sponsor of the multi-centre clinical trial, and the PM served as the overall Clinical Trial Administrator. Each centre was led by a Principal Investigator (PI), running the trial together with the local daily responsible. The tasks and responsibilities for the clinical trial of the Coordinating Centre were shared between Copenhagen and Helsinki centres. The trial was overall led by the Clinical Trial Manager (CTM), who was the PI at the Helsinki centre. The local Independent Ethical Committees approved the protocol prior to the start of the intervention. One member of the SAB acted as Ethical Officer. The trial/study had an overall statistician. The Analyst role was shared among different people from the Copenhagen and Helsinki centres. The DM created and maintained database for the intervention and the Clinical Report Forms by using OpenClinica open source software. The staff in the intervention received training in Good Clinical Practices, the protocol and its procedures. The monitoring tasks were jointly undertaken by the Sponsor and the CTM. The documents from the Trial Master File were saved in the Internal Repository. A set of Standard Operation Procedures was defined. Meetings among all PIs, and within the Instructors’ Network were key in the success of the intervention. This case study aims at serving as guidance to coordinating researchers, both during the proposal preparation and project implementation phases, as well as to provide visibility and insight into the multi-faceted role of the project managers and administrators of such projects

Genome-wide association study of primary sclerosing cholangitis identifies new risk loci and quantifies the genetic relationship with inflammatory bowel disease.

Primary sclerosing cholangitis (PSC) is a rare progressive disorder leading to bile duct destruction; ∼75% of patients have comorbid inflammatory bowel disease (IBD). We undertook the largest genome-wide association study of PSC (4,796 cases and 19,955 population controls) and identified four new genome-wide significant loci. The most associated SNP at one locus affects splicing and expression of UBASH3A, with the protective allele (C) predicted to cause nonstop-mediated mRNA decay and lower expression of UBASH3A. Further analyses based on common variants suggested that the genome-wide genetic correlation (rG) between PSC and ulcerative colitis (UC) (rG = 0.29) was significantly greater than that between PSC and Crohn's disease (CD) (rG = 0.04) (P = 2.55 × 10-15). UC and CD were genetically more similar to each other (rG = 0.56) than either was to PSC (P &lt; 1.0 × 10-15). Our study represents a substantial advance in understanding of the genetics of PSC

Genome-wide association study of primary sclerosing cholangitis identifies new risk loci and quantifies the genetic relationship with inflammatory bowel disease

Primary sclerosing cholangitis (PSC) is a rare progressive disorder leading to bile duct destruction; ∼75% of patients have comorbid inflammatory bowel disease (IBD). We undertook the largest genome-wide association study of PSC (4,796 cases and 19,955 population controls) and identified four new genome-wide significant loci. The most associated SNP at one locus affects splicing and expression of UBASH3A, with the protective allele (C) predicted to cause nonstop-mediated mRNA decay and lower expression of UBASH3A. Further analyses based on common variants suggested that the genome-wide genetic correlation (rG) between PSC and ulcerative colitis (UC) (rG = 0.29) was significantly greater than that between PSC and Crohn's disease (CD) (rG = 0.04) (P = 2.55 × 10-15). UC and CD were genetically more similar to each other (rG = 0.56) than either was to PSC (P < 1.0 × 10-15). Our study represents a substantial advance in understanding of the genetics of PSC