The effectiveness and cost-evaluation of manual therapy and physical therapy in patients with sub-acute and chronic non specific neck pain. Rationale and design of a Randomized Controlled Trial (RCT)

Contains fulltext : 88910.pdf (publisher's version ) (Open Access)BACKGROUND: Manual Therapy applied to patients with non specific neck pain has been investigated several times. In the Netherlands, manual therapy as applied according to the Utrecht School of Manual Therapy (MTU) has not been the subject of a randomized controlled trial. MTU differs in diagnoses and treatment from other forms of manual therapy. METHODS/DESIGN: This is a single blind randomized controlled trial in patients with sub-acute and chronic non specific neck pain. Patients with neck complaints existing for two weeks (minimum) till one year (maximum) will participate in the trial. 180 participants will be recruited in thirteen primary health care centres in the Netherlands.The experimental group will be treated with MTU during a six week period. The control group will be treated with physical therapy (standard care, mainly active exercise therapy), also for a period of six weeks.Primary outcomes are Global Perceived Effect (GPE) and functional status (Neck Disability Index (NDI-DV)). Secondary outcomes are neck pain (Numeric Rating Scale (NRS)), Eurocol, costs and quality of life (SF36). DISCUSSION: This paper presents details on the rationale of MTU, design, methods and operational aspects of the trial. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00713843

Vaccination of patients with autoimmune inflammatory rheumatic diseases

Patients with autoimmune inflammatory rheumatic diseases (AIRDs) are at increased risk of infections. This risk has been further increased by the introduction of biologic agents over the past two decades. One of the most effective strategies to prevent infection is vaccination. However, patients with an AIRD have a compromised immune system, which is further impaired by medication. Another important issue is the possibility of triggering a broad nonspecific response by vaccination, potentially resulting in increased activity of the underlying autoimmune disease. In this Review, we provide an analysis of data on vaccination of patients with an AIRD. Both the efficacy and the safety of vaccination are addressed, together with the epidemiology of vaccine-preventable infectious diseases in different subgroups of adults with AIRDs. Special attention is given to vaccination of patients who are treated with biologic agents

Examining reproducibility in psychology:A hybrid method for combining a statistically significant original study and a replication

The unrealistically high rate of positive results within psychology has increased the attention to replication research. However, researchers who conduct a replication and want to statistically combine the results of their replication with a statistically significant original study encounter problems when using traditional meta-analysis techniques. The original study’s effect size is most probably overestimated because it is statistically significant, and this bias is not taken into consideration in traditional meta-analysis. We have developed a hybrid method that does take the statistical significance of an original study into account and enables (a) accurate effect size estimation, (b) estimation of a confidence interval, and (c) testing of the null hypothesis of no effect. We analytically approximate the performance of the hybrid method and describe its statistical properties. By applying the hybrid method to data from the Reproducibility Project: Psychology (Open Science Collaboration, 2015), we demonstrate that the conclusions based on the hybrid method are often in line with those of the replication, suggesting that many published psychological studies have smaller effect sizes than those reported in the original study, and that some effects may even be absent. We offer hands-on guidelines for how to statistically combine an original study and replication, and have developed a Web-based application (https://rvanaert.shinyapps.io/hybrid) for applying the hybrid method

Examining reproducibility in psychology : A hybrid method for combining a statistically significant original study and a replication

The unrealistically high rate of positive results within psychology has increased the attention to replication research. However, researchers who conduct a replication and want to statistically combine the results of their replication with a statistically significant original study encounter problems when using traditional meta-analysis techniques. The original study’s effect size is most probably overestimated because it is statistically significant, and this bias is not taken into consideration in traditional meta-analysis. We have developed a hybrid method that does take the statistical significance of an original study into account and enables (a) accurate effect size estimation, (b) estimation of a confidence interval, and (c) testing of the null hypothesis of no effect. We analytically approximate the performance of the hybrid method and describe its statistical properties. By applying the hybrid method to data from the Reproducibility Project: Psychology (Open Science Collaboration, 2015), we demonstrate that the conclusions based on the hybrid method are often in line with those of the replication, suggesting that many published psychological studies have smaller effect sizes than those reported in the original study, and that some effects may even be absent. We offer hands-on guidelines for how to statistically combine an original study and replication, and have developed a Web-based application (https://rvanaert.shinyapps.io/hybrid) for applying the hybrid method