Patch-augmented rotator cuff surgery (PARCS) study-protocol for a feasibility study

Background: A rotator cuff tear is a common disabling shoulder problem. Symptoms include pain, weakness, lack of shoulder mobility and sleep disturbance. Many patients require surgery to repair the tear; however, there is a high failure rate. There is a pressing need to improve the outcome of rotator cuff surgery and the use of patch augmentation to provide support to the healing process and improve patient outcomes holds new promise. Patches have been made using different materials (e.g. human/animal skin or intestine tissue, and completely synthetic materials) and processes (e.g. woven or a mesh). However, clinical evidence on their use is limited. The aim of the patch-augmented rotator cuff surgery (PARCS) feasibility study is to determine, using a mixed method approach, the design of a definitive randomised trial assessing the effectiveness and cost-effectiveness of a patch to augment surgical repair of the rotator cuff that is both acceptable to stakeholders and feasible. Methods: The objectives of this six-stage mixed methods feasibility study are to determine current practice, evidence and views about patch use; achieve consensus on the design of a randomised trial to evaluate patch-augmented rotator cuff surgery; and assess the acceptability and feasibility of the proposed design. The six stages will involve a systematic review of clinical evidence, two surveys of surgeons, focus groups and interviews with stakeholders, a Delphi study and a consensus meeting. The various stakeholders (including patients, surgeons, and representatives from industry, the NHS and regulatory bodies) will be involved across the six stages. Discussion: The PARCS feasibility study will inform the feasibility and acceptability of a randomised trial of the effectiveness and cost-effectiveness of a patch-augmented rotator cuff surgery. Consensus opinion on the basic design of a randomised trial will be sought. Trial registration: Not applicable

Considerations and methods for placebo controls in surgical trials (ASPIRE guidelines)

Placebo comparisons are increasingly being considered for randomised trials assessing the efficacy of surgical interventions. The aim of this Review is to provide a summary of knowledge on placebo controls in surgical trials. A placebo control is a complex type of comparison group in the surgical setting and, although powerful, presents many challenges. This Review outlines what a placebo control entails and present understanding of this tool in the context of surgery. We consider when placebo controls in surgery are acceptable (and when they are desirable) in terms of ethical arguments and regulatory requirements, how a placebo control should be designed, how to identify and mitigate risk for participants in these trials, and how such trials should be done and interpreted. Use of placebo controls is justified in randomised controlled trials of surgical interventions provided there is a strong scientific and ethical rationale. Surgical placebos might be most appropriate when there is poor evidence for the efficacy of the procedure and a justified concern that results of a trial would be associated with high risk of bias, particularly because of the placebo effect. Feasibility work is recommended to optimise the design and implementation of randomised controlled trials. This Review forms an outline for best practice and provides guidance, in the form of the Applying Surgical Placebo in Randomised Evaluations (known as ASPIRE) checklist, for those considering the use of a placebo control in a surgical randomised controlled trial

Boundary Element Method Numerical Modeling: An Approach for Analyzing the Complex Geometry and Evolution of the San Gorgonio Knot, San Andreas Fault, Southern California

The San Andreas fault forms the right lateral transform boundary between the North American and Pacific tectonic plates. At various locations along the San Andreas fault the geometry of the fault surface is much more complex than a straight, vertical, plane. The San Bernardino Mountain segment of the San Andreas fault, in the San Gorgonio Pass region has one of the most complex active fault geometries in southern California due to a left-stepping restraining bend in the San Andreas fault. The evolution of the actively faulting pass has created an intricate network of active and formerly active, dipping and vertical, three-dimensionally irregular fault surfaces. The purpose of this research is to gain a better understanding of the mechanics of the present day active fault geometry and the evolution in the San Gorgonio pass region, through numerical modeling. We use the three-dimensional Boundary Element Method modeling code Poly3D to simulate different fault configurations. We see that fault geometries that include geologically observed and inferred fault dips match geologic data more accurately than simplified, vertical faults in the San Gorgonio Pass region of the San Andreas fault. The evolution of the San Andreas Fault in the San Gorgonio Pass region over the past million years may follow the principle of work minimization in the Earth’s crust up until the present day configuration

A study of the processes of charging and discharging constant volume tanks with air by C.K. Wagner, F.D. Skinner.

Thesis (B.S.)--Massachusetts Institute of Technology, Dept. of Mechanical Engineering, 1953.B.S

The effects of status differentiation on nonverbal behaviour

An experiment was conducted to investigate relationships between status and nonverbal behavior. Subjects were randomly assigned to a high status position (teacher) or a low status position (student). Status was crossed with gender to produce four treatment conditions: males teaching males, males teaching females, females teaching males, and females teaching females. Statuses were then reversed on a second trial: former students became teachers and former teachers became students with the same partners. Nonverbal behavior from both interactions was recorded and coded from videotape. Findings indicate that status structures nonverbal behavior. In general, high specic status subjects (teachers) claimed more direct space with their bodies, talked more, and attempted more interruptions than their low status counterparts. And, by means of touching and pointing (both to their partner and to the partner's possessions), they symbolically intruded upon their partners noticeably more than their partners intruded upon them. Similarly, gender affected nonverbal behavior: males took more horizontal space, pointed to possessions more often, touched more frequently, and laughed less than females. The set of behaviors organized by specc status differed somewhat from the set of behaviors that showed diffuse status effects

SNP Data Quality Control in a National Beef and Dairy Cattle System and Highly Accurate SNP Based Parentage Verification and Identification

A major use of genetic data is parentage verification and identification as inaccurate pedigrees negatively affect genetic gain. Since 2012 the international standard for single nucleotide polymorphism (SNP) verification in Bos taurus cattle has been the ISAG SNP panels. While these ISAG panels provide an increased level of parentage accuracy over microsatellite markers (MS), they can validate the wrong parent at ≤1% misconcordance rate levels, indicating that more SNP are needed if a more accurate pedigree is required. With rapidly increasing numbers of cattle being genotyped in Ireland that represent 61 B. taurus breeds from a wide range of farm types: beef/dairy, AI/pedigree/commercial, purebred/crossbred, and large to small herd size the Irish Cattle Breeding Federation (ICBF) analyzed different SNP densities to determine that at a minimum ≥500 SNP are needed to consistently predict only one set of parents at a ≤1% misconcordance rate. For parentage validation and prediction ICBF uses 800 SNP (ICBF800) selected based on SNP clustering quality, ISAG200 inclusion, call rate (CR), and minor allele frequency (MAF) in the Irish cattle population. Large datasets require sample and SNP quality control (QC). Most publications only deal with SNP QC via CR, MAF, parent-progeny conflicts, and Hardy-Weinberg deviation, but not sample QC. We report here parentage, SNP QC, and a genomic sample QC pipelines to deal with the unique challenges of >1 million genotypes from a national herd such as SNP genotype errors from mis-tagging of animals, lab errors, farm errors, and multiple other issues that can arise. We divide the pipeline into two parts: a Genotype QC and an Animal QC pipeline. The Genotype QC identifies samples with low call rate, missing or mixed genotype classes (no BB genotype or ABTG alleles present), and low genotype frequencies. The Animal QC handles situations where the genotype might not belong to the listed individual by identifying: >1 non-matching genotypes per animal, SNP duplicates, sex and breed prediction mismatches, parentage and progeny validation results, and other situations. The Animal QC pipeline make use of ICBF800 SNP set where appropriate to identify errors in a computationally efficient yet still highly accurate method