Toward full life cycle control: Adding maintenance measurement to the SEL

Organization-wide measurement of software products and processes is needed to establish full life cycle control over software products. The Software Engineering Laboratory (SEL)--a joint venture between NASA GSFC, the University of Maryland, and Computer Sciences Corporation--started measurement of software development more than 15 years ago. Recently, the measurement of maintenance was added to the scope of the SEL. In this article, the maintenance measurement program is presented as an addition to the already existing and well-established SEL development measurement program and evaluated in terms of its immediate benefits and long-term improvement potential. Immediate benefits of this program for the SEL include an increased understanding of the maintenance domain, the differences and commonalities between development and maintenance, and the cause-effect relationships between development and maintenance. Initial results from a sample maintenance study are presented to substantiate these benefits. The long-term potential of this program includes the use of maintenance baselines to better plan and manage future projects and to improve development and maintenance practices for future projects wherever warranted

Experience Factory.

INTRODUCTION Reuse of products, processes and experience originating from the system life cycle is seen today as a feasible solution to the problem of developing higher quality systems at a lower cost. In fact, quality improvement is very often achieved by reusing and modifying over and over the same elements, learning about them by direct experience. This article presents an infrastructure, called the experience factory, aimed at capitalization and reuse of life cycle experience and products. The experience factory is a logical and physical organization, and its activities are independent from the ones of the development organization. The activities of the development organization and of the experience factory can be outlined in the following way: • The development organization, whose mission is to develop and deliver systems, provides the experience factory with product development and environment characteristics, data, and a diversity of models (resources, quality, product, process) currently used by the projects in order to deliver their capabilities. • The experience factory, through processing this information and other state-ofthe-practice notions, will return direct feedback to each project activity, together with goals and models tailored from previous project increments. It will als

Orientation dependence of thermal and mechanical hysteresis in Ni51Fe18Ga27Co4 single crystals

The orientation dependence of thermal ΔТ and mechanical Δσ hysteresis was investigated in Ni51Fe18Ga27Co4 single crystals as-grown with isobaric (shape memory effect) and isothermal (superelasticity) experiments. Single crystals oriented along the [001]-direction show a high reversible deformation of 001 ЭПФ ε = (4,0 ± 0,2) % for martensitic transformations, small thermal hysteresis ΔТ = (22 ± 2) K and mechanical Δσ001 = (47 ± 2) МПа hysteresis, as compared with to single crystals oriented along the [110]-direction. Such orientation dependence is determined by the contribution of the L10-martensite under the εdetw in deformation of transformation

Core-periphery structure in networks (revisited)

Intermediate-scale (or 'meso-scale') structures in networks have received considerable attention, as the algorithmic detection of such structures makes it possible to discover network features that are not apparent either at the local scale of nodes and edges or at the global scale of summary statistics. Numerous types of meso-scale structures can occur in networks, but investigations of meso-scale network features have focused predominantly on the identification and study of community structure. In this paper, we develop a new method to investigate the meso-scale feature known as coreperiphery structure, which consists of an identification of a network's nodes into a densely connected core and a sparsely connected periphery. In contrast to traditional network communities, the nodes in a core are also reasonably well-connected to those in the periphery. Our new method of computing core-periphery structure can identify multiple cores in a network and takes different possible cores into account, thereby enabling a detailed description of core-periphery structure. We illustrate the differences between our method and existing methods for identifying which nodes belong to a core, and we use it to classify the most important nodes using examples of friendship, collaboration, transportation, and voting networks

Study of Peri-Articular Anaesthetic for Replacement of the Knee (SPAARK): statistical analysis plan for a randomised controlled trial assessing the effectiveness of peri-articular liposomal bupivacaine plus bupivacaine hydrochloride compared with bupivacaine hydrochloride alone

Background Up to three quarters of surgical patients receive inadequate pain relief, with 40% of patients reporting severe pain following knee replacement, which may indicate the current pain relief strategies using opiate-based analgesia cannot achieve patient satisfaction. Liposomal bupivacaine is liposome-encapsulated bupivacaine which has been reported to be effective for up to 72 h. The study of Peri-Articular Anaesthetic for Replacement of the Knee (SPAARK) trial has been designed to assess the effectiveness of peri-articular liposomal bupivacaine and bupivacaine hydrochloride compared with peri-articular bupivacaine hydrochloride alone in the management of post-operative pain following knee replacement. Methods/design The SPAARK trial is a multi-centre, patient-blinded, randomised controlled trial. The co-primary outcomes are post-operative recovery assessed by global QoR-40 scores at 72 h and cumulative pain VAS score from 6 to 72 h following surgery. Longer-term measures of the co-primary outcomes are collected at 6 weeks and 6 and 12 months post randomisation, together with secondary outcomes, i.e. the Oxford Knee Score, and the American Knee Society Score. Cumulative opiate use and fitness for discharge are measured up to 72 h post-surgery. The analysis approaches for the primary and secondary outcomes are described here, as are the descriptive statistics which will be reported. The full SPAARK protocol has already been published. Results The co-primary outcomes will be analysed using multivariate linear regression adjusting for stratification factors and other important prognostic variables, including baseline scores in the case of the QoR-40. The adjusted mean difference between the two groups together with 97.5% confidence intervals will be reported for each of the primary outcomes. Other continuous variables will be assessed using the same method. Binary outcomes will be assessed using chi-squared tests. Discussion The paper provides details of the planned statistical analyses for the SPAARK trial and aims to reduce the risk of outcome reporting bias from prior data knowledge. Any changes or deviations from this statistical analysis plan will be described and justified in the final study report

Cost-effectiveness of adalimumab for early-stage Dupuytren’s disease

Aims: To estimate the potential cost-effectiveness of adalimumab compared with standard care alone for the treatment of early-stage Dupuytren’s disease (DD) and the value of further research from an NHS perspective. Methods: We used data from the Repurposing anti-TNF for Dupuytren’s disease (RIDD) randomized controlled trial of intranodular adalimumab injections in patients with early-stage progressive DD. RIDD found that intranodular adalimumab injections reduced nodule hardness and size in patients with early-stage DD, indicating the potential to control disease progression. A within-trial cost-utility analysis compared four adalimumab injections with no further treatment against standard care alone, taking a 12-month time horizon and using prospective data on EuroQol five-dimension five-level questionnaire (EQ-5D-5L) and resource use from the RIDD trial. We also developed a patient-level simulation model similar to a Markov model to extrapolate trial outcomes over a lifetime using data from the RIDD trial and a literature review. This also evaluated repeated courses of adalimumab each time the nodule reactivated (every three years) in patients who initially responded. Results: The within-trial economic evaluation found that adalimumab plus standard care cost £503,410 per quality-adjusted life year (QALY) gained versus standard care alone over a 12-month time horizon. The model-based extrapolation suggested that, over a lifetime, repeated courses of adalimumab could cost £14,593 (95% confidence interval £7,534 to £42,698) per QALY gained versus standard care alone. If the NHS was willing to pay £20,000/QALY gained, there is a 77% probability that adalimumab with retreatment is the best value for money. Conclusion: Repeated courses of adalimumab are likely to be a cost-effective treatment for progressive early-stage DD. The value of perfect parameter information that would eliminate all uncertainty around the parameters estimated in RIDD and the duration of quiescence was estimated to be £105 per patient or £272 million for all 2,584,411 prevalent cases in the UK

Cost-effectiveness of adalimumab for early-stage Dupuytren's disease : an economic evaluation based on a randomized controlled trial and individual-patient simulation model.

This is the final version. Available from British Editorial Society of Bone & Joint Surgery via the DOI in this record. Data sharing: Aggregate data will be shared at the end of the trial with external researchers who provide a methodologically sound proposal to the trial team (and will be required to sign a data sharing access agreement with the sponsor) and in accordance with the guidelines of the sponsor and funders. Model code may also be available in due course, on request. Study documents including participant consent form can also be made available. Requests for data or study documents should be directed to the corresponding author and will be considered by the chief investigator in conjunction with other members of the trial management group and the trials unit.AIMS: To estimate the potential cost-effectiveness of adalimumab compared with standard care alone for the treatment of early-stage Dupuytren's disease (DD) and the value of further research from an NHS perspective. METHODS: We used data from the Repurposing anti-TNF for Dupuytren's disease (RIDD) randomized controlled trial of intranodular adalimumab injections in patients with early-stage progressive DD. RIDD found that intranodular adalimumab injections reduced nodule hardness and size in patients with early-stage DD, indicating the potential to control disease progression. A within-trial cost-utility analysis compared four adalimumab injections with no further treatment against standard care alone, taking a 12-month time horizon and using prospective data on EuroQol five-dimension five-level questionnaire (EQ-5D-5L) and resource use from the RIDD trial. We also developed a patient-level simulation model similar to a Markov model to extrapolate trial outcomes over a lifetime using data from the RIDD trial and a literature review. This also evaluated repeated courses of adalimumab each time the nodule reactivated (every three years) in patients who initially responded. RESULTS: The within-trial economic evaluation found that adalimumab plus standard care cost £503,410 per quality-adjusted life year (QALY) gained versus standard care alone over a 12-month time horizon. The model-based extrapolation suggested that, over a lifetime, repeated courses of adalimumab could cost £14,593 (95% confidence interval £7,534 to £42,698) per QALY gained versus standard care alone. If the NHS was willing to pay £20,000/QALY gained, there is a 77% probability that adalimumab with retreatment is the best value for money. CONCLUSION: Repeated courses of adalimumab are likely to be a cost-effective treatment for progressive early-stage DD. The value of perfect parameter information that would eliminate all uncertainty around the parameters estimated in RIDD and the duration of quiescence was estimated to be £105 per patient or £272 million for all 2,584,411 prevalent cases in the UK. Cite this article: Bone Jt Open 2022;3(11):898-906.Wellcome TrustDepartment of Health UK180 Therapeutics LPNational Institute for Health and Care Researc

Anti-tumour necrosis factor therapy for early-stage Dupuytren's disease (RIDD): a phase 2b, randomised, double-blind, placebo-controlled trial

Background Dupuytren's disease is a common fibrotic condition that causes the fingers to flex irreversibly into the palm. Treatments for late-stage disease all have limitations, and there is no approved treatment for early-stage disease. We identified tumour necrosis factor as a therapeutic target in Dupuytren's disease, and in a dose ranging trial found 40 mg adalimumab in 0·4 mL to be most efficacious. Here we aimed to assess the effects of intranodular injection of adalimumab in early-stage disease. Methods In this phase 2b, randomised, double-blind, placebo-controlled trial adults with early-stage Dupuytren's disease and an established clinically distinct nodule with a clear history of progression in the preceding 6 months were recruited from two clinical centres in the UK and were randomly assigned 1:1 to receive four injections of adalimumab or saline every 3 months. Participants and assessors were masked. The primary outcome was nodule hardness measured with a durometer at 12 months. Data were analysed by linear mixed effects regression models in the intention-to-treat population with multiple imputation for missing primary outcome data. The trial is registered at the ISRCTN registry, ISRCTN 27786905 and is complete. Findings Between Feb 17, 2017, and Jan 11, 2019, 284 participants were screened in the UK and 140 were enrolled. 47 (34%) participants were female and 93 (66%) were male. Mean age of participants was 59·7 years (SD 10·0). Primary outcome data were available from 113 participants. Nodule hardness was lower (−4·6 AU [95% CI −7·1 to −2·2], p=0·0002) in the adalimumab compared with the saline group at 12 months. There were no related serious adverse events; the most common adverse events were minor injection site reactions. Interpretation Intranodular injections of adalimumab in participants with early-stage Dupuytren's disease resulted in softening and reduction in size of the nodules. Longer follow-up would be required to assess the effect of tumour necrosis factor inhibition on disease progression, extension deficit and hand function. Funding Health Innovation Challenge Fund (Wellcome Trust, Department of Health) and 180 Life Sciences

Alumina nanoparticle interfacial buffer layer for low‐bandgap lead‐tin perovskite solar cells

Mixed lead-tin (Pb:Sn) halide perovskites are promising absorbers with narrow-bandgaps (1.25–1.4 eV) suitable for high-efficiency all-perovskite tandem solar cells. However, solution processing of optimally thick Pb:Sn perovskite films is notoriously difficult in comparison with their neat-Pb counterparts. This is partly due to the rapid crystallization of Sn-based perovskites, resulting in films that have a high degree of roughness. Rougher films are harder to coat conformally with subsequent layers using solution-based processing techniques leading to contact between the absorber and the top metal electrode in completed devices, resulting in a loss of VOC, fill factor, efficiency, and stability. Herein, this study employs a non-continuous layer of alumina nanoparticles distributed on the surface of rough Pb:Sn perovskite films. Using this approach, the conformality of the subsequent electron-transport layer, which is only tens of nanometres in thickness is improved. The overall maximum-power-point-tracked efficiency improves by 65% and the steady-state VOC improves by 28%. Application of the alumina nanoparticles as an interfacial buffer layer also results in highly reproducible Pb:Sn solar cell devices while simultaneously improving device stability at 65 °C under full spectrum simulated solar irradiance. Aged devices show a six-fold improvement in stability over pristine Pb:Sn devices, increasing their lifetime to 120 h