Bayesian Approach to Three Arm Non-Inferiority Clinical Trial Using Negative Binomial Endpoint

Non inferiority clinical trials have gained immense popularity within the last decades. Such trials are designed to demonstrate that a new experimental drug is not unacceptably worse than an active control by more than a pre-specified margin. The experimental treatment may not be as good as the active control concerning efficacy, however, the former may offer substantial benefits over the later such as less invasive, lower toxicity, cost-effective, etc. Therefore, a slightly less efficacious treatment can still be acceptable as a treatment alternative to certain groups of patients. Three-arm non-inferiority trials, involving an active control along with an experimental treatment and a placebo arm, have been widely acknowledged as the Gold Standard because they can simultaneously establish both non-inferiority and the assay sensitivity of the treatment under same study. Bayesian approach to assess non-inferiority under continuous end-point has been studied in recent past but such models were never investigated using count data. One obvious recommendation will be the choice of Poisson distribution to model the primary end-point, but Poisson distribution is often affected by over-dispersion. Instead, a Poisson and Gamma mixture, which ultimately results in \textit{Negative Binomial Distribution}, can be a suitable alternative to model count data. In this paper, we propose a Bayesian hierarchical model to perform simultaneous testing of non-inferiority and assay sensitivity in a three-arm trial under the situation that the primary endpoints are negative binomially distributed in the presence of placebo-controlled historical trial. The Bayesian approach allows for the inclusion of historical information by constructing appropriate prior to the current trials, which may result in a significant reduction of sample size while preserving high power. Furthermore, we examined the effect of power prior (Ibrahim and Chen, 2000) under the proposed model setup through a simulation study. Finally, the performance of the proposed model is evaluated based on simulated dataset under varying scenario

Commodity Alliance Model – An Option for Advancing Private and Commercial Extension Service Delivery in Nigeria

Despite improved technologies and several extension approaches being tried in Nigeria, arable croppers’ productivity has been consistently low. Moreover farmers are usually not totally enthusiastic about sustained use of proven technologies due to unfavorable economic and policy environment within which they operate. More than ever before, farmers are being careful to produce only what they have been assured market for. Meanwhile, processors and produce-buyers are in short supply of raw materials. The government operated public extension tends to give much attention to production and less to post harvest handling and marketing. To induce farmers to produce optimally, effective innovative approaches to production and marketing that ensure adequate value addition and ultimate remunerative price for farmers’ produce would have to be in place. The presidential initiatives on cassava and rice have expanded the markets such that producers need inducement and special assistance from relevant agri-service providers in marketing their produce. To derive the desired impact of cassava initiative on the national economy, an efficient and well-integrated production and marketing system is necessary to assure a steady supply of cassava products to domestic industries and European markets. It is also in the same vein that rice producers need to be more structured in their production agenda and be assured of their produce markets. One of the innovative approaches being applied to boost cassava and rice production in Nigeria is the use of groups of out-growers. Several lessons have been learnt from two different cases in contract farming. The lessons culminated in an innovative private extension model where independent extension agency brokers an effective production and marketing environment for income yielding commodities. Based on the lessons learnt from selected projects, the Farm and Infrastructure Foundation (FIF) has packaged a strengthened commodity – alliance model for sourcing raw materials for agro-based companies using out-growers in Nigeria. In this innovative model FIF as an independent organization creates a platform for effective linkage of markets and farmers for each commodity, and integrating them in terms of fair price determination, information flow and issues resolution. The FIF model will create an in-road for strengthening private extension practice in Nigeria

Commodity Alliance Model – An Option for Advancing Private and Commercial Extension Service Delivery in Nigeria

Despite improved technologies and several extension approaches being tried in Nigeria, arable croppers’ productivity has been consistently low. Moreover farmers are usually not totally enthusiastic about sustained use of proven technologies due to unfavorable economic and policy environment within which they operate. More than ever before, farmers are being careful to produce only what they have been assured market for. Meanwhile, processors and produce-buyers are in short supply of raw materials. The government operated public extension tends to give much attention to production and less to post harvest handling and marketing. To induce farmers to produce optimally, effective innovative approaches to production and marketing that ensure adequate value addition and ultimate remunerative price for farmers’ produce would have to be in place. The presidential initiatives on cassava and rice have expanded the markets such that producers need inducement and special assistance from relevant agri-service providers in marketing their produce. To derive the desired impact of cassava initiative on the national economy, an efficient and well-integrated production and marketing system is necessary to assure a steady supply of cassava products to domestic industries and European markets. It is also in the same vein that rice producers need to be more structured in their production agenda and be assured of their produce markets. One of the innovative approaches being applied to boost cassava and rice production in Nigeria is the use of groups of out-growers. Several lessons have been learnt from two different cases in contract farming. The lessons culminated in an innovative private extension model where independent extension agency brokers an effective production and marketing environment for income yielding commodities. Based on the lessons learnt from selected projects, the Farm and Infrastructure Foundation (FIF) has packaged a strengthened commodity – alliance model for sourcing raw materials for agro-based companies using out-growers in Nigeria. In this innovative model FIF as an independent organization creates a platform for effective linkage of markets and farmers for each commodity, and integrating them in terms of fair price determination, information flow and issues resolution. The FIF model will create an in-road for strengthening private extension practice in Nigeria

Control Design of an Inverted Pendulum on a Moving Base Using State Feedback

A fascinating and essential control problem for researchers is the inverted pendulum. It remains a generally accepted standard used in control and robotics for validation of emerging control technologies. A mathematical model of the inverted pendulum on a moving base system was derived, an expression of the linearised state space representation of the system was also presented, a controller to achieve specific criterion of the steady state error, rise and settling time, and was obtained, an implementation of this control on MATLAB was carried out together with the simulated animation of the system using Simulink and Simscap

Mismatch between school furniture dimensions and anthropometric parameters is a risk for spinal deformities in secondary school students in Lagos, Nigeria: a cross-sectional study

Abstract Background A mismatch between school furniture dimensions and anthropometric parameters has been well documented in adolescents, but there is a paucity of data on the impact of these mismatches on the students’ spinal health in Nigeria. This study therefore investigated the relationship of spinal deformities with selected anthropometric parameters and furniture dimensions of adolescents in secondary schools. Methods This study involved 540 apparently healthy students between the ages of 10 and 19 years from 9 public and private secondary schools in Lagos state, Nigeria. The furniture dimensions, anthropometric parameters, and spinal curvature disorders were evaluated using standard protocol. Data was analyzed using SPSS version 20.0 with a level of significance set at p < 0.05. Results Two hundred two (37%) of the participants had abnormal spinal curvatures in varying types and degrees. There was a significant association at p ≤ 0.05 between the presence of spinal deformities and popliteal height to seat height mismatch (X 2 = 175.67, p = 0.001), hip breadth to seat width mismatch (X 2 = 293.14, p = 0.00), and shoulder height to backrest height mismatch (X 2 = 788.16, p = 0.001). Conclusion Anthropometric parameters to furniture dimensions mismatch are significantly associated with the presence of spinal deformities among the students. The main cause of mismatch is using a homogeneous size of furniture for all students in addition to non-consideration of the students’ dimensions during furniture manufacturing

Systematic review of economic evaluations investigating education, exercise, and dietary weight management to manage hip and knee osteoarthritis: protocol

Abstract Background International guidelines recommend education, exercise, and dietary weight management as core treatments to manage osteoarthritis (OA) regardless of disease severity or co-morbidity. Evidence supports the clinical effectiveness of OA management programs, but the cost-effectiveness of core treatments remains unclear. We will systematically review, synthesize, and assess the literature in economic evaluations of core treatments (education, exercise, and dietary weight management) for the management of hip and/or knee OA. Methods We will search the following elecftronic databases (from inception onwards): MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), National Health Services Economic Evaluation Database, and EconLit. Economic evaluations alongside randomized or nonrandomized clinical trials investigating OA education, exercise, and dietary weight management interventions will be included. Title, abstract, and full text of relevant publications will be screened independently by two reviewers. A content matter expert will resolve any conflicts between two reviewers. Key information from relevant papers will be extracted and tabulated to provide an overview of the published literature. Methodological quality will be evaluated using the Consensus on Health Economic Criteria list. A narrative synthesis without meta-analysis will be conducted. Subgroup analysis will attempt to find trends between research methods, intervention characteristics, and results. Discussion The findings of this review will evaluate the breadth and quality of economic evaluations conducted alongside clinical trials for core treatments in OA management. Systematic review registration PROSPERO CRD4202015596

PrEvention of posttraumatic contractuRes with Ketotifen 2 (PERK 2) – protocol for a multicenter randomized clinical trial

Abstract Background Injuries and resulting stiffness around joints, especially the elbow, have huge psychological effects by reducing quality of life through interference with normal daily activities such as feeding, dressing, grooming, and reaching for objects. Over the last several years and through numerous research results, the myofibroblast-mast cell-neuropeptide axis of fibrosis had been implicated in post-traumatic joint contractures. Pre-clinical models and a pilot randomized clinical trial (RCT) demonstrated the feasibility and safety of using Ketotifen Fumarate (KF), a mast cell stabilizer to prevent elbow joint contractures. This study aims to evaluate the efficacy of KF in reducing joint contracture severity in adult participants with operately treated elbow fractures and/or dislocations. Methods/design A Phase III randomized, controlled, double-blinded multicentre trial with 3 parallel groups (KF 2 mg or 5 mg or lactose placebo twice daily orally for 6 weeks). The study population consist of adults who are at least 18 years old and within 7 days of injury. The types of injuries are distal humerus (AO/OTA type 13) and/or proximal ulna and/or proximal radius fractures (AO/OTA type 2 U1 and/or 2R1) and/or elbow dislocations (open fractures with or without nerve injury may be included). A stratified randomization scheme by hospital site will be used to assign eligible participants to the groups in a 1:1:1 ratio. The primary outcome is change in elbow flexion-extension range of motion (ROM) arc from baseline to 12 weeks post-randomization. The secondary outcomes are changes in ROM from baseline to 6, 24 & 52 weeks, PROMs at 2, 6, 12, 24 & 52 weeks and impact of KF on safety including serious adverse events and fracture healing. Descriptive analysis for all outcomes will be reported and ANCOVA be used to evaluate the efficacy KF over lactose placebo with respect to the improvement in ROM. Discussion The results of this study will provide evidence for the use of KF in reducing post-traumatic joint contractures and improving quality of life after joint injuries. Trial registration This study was prospectively registered (July 10, 2018) with ClinicalTrials.gov reference: NCT03582176