219 research outputs found

    PMH56 A PATIENT PERSPECTIVE ON SIDE EFFECTS OF ANTIPSYCHOTIC THERAPY: THE TOOL INSTRUMENT

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    A Case Study Evaluation of the Guideline-Supported QUPER Model for Elicitation of Quality Requirements

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    [Context & motivation] For market-driven software product developing organizations operating on a competitive open market, it is important to plan the product’s releases so that they can reach the market as early as possible with a competitive level of quality compared to its competitors' products. Hence, quality requirements can be seen as a key competitive advantage. The QUPER model was developed with the aim to support high-level decision-making in release planning of quality requirements. [Question/problem] As a follow up on previous studies on QUPER, this study investigates: What are practitioner's views on the utilities of QUPER extended with guidelines including domain-specific examples? [Principal ideas/results] In the presented case study, a set of detailed guidelines of how to apply QUPER in practice, including how to handle cost dependencies between quality requirements, was evaluated at a case company in the mobile handset domain with 24 professionals using real quality requirements. [Contribution] The results point to the importance of having concrete guidelines combined with instructive examples from real practice, while it is not always obvious for a practitioner to transfer cost-dependency examples into the domains that are different from the example domain. The transferability of guidelines and examples to support methodology adoption is an interesting issue for further research

    Technical debt and waste in non-functional requirements documentation:an exploratory study

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    Background: To adequately attend to non-functional requirements (NFRs), they must be documented; otherwise, developers would not know about their existence. However, the documentation of NFRs may be subject to Technical Debt and Waste, as any other software artefact. Aims: The goal is to explore indicators of potential Technical Debt and Waste in NFRs documentation. Method: Based on a subset of data acquired from the most recent NaPiRE (Naming the Pain in Requirements Engineering) survey, we calculate, for a standard set of NFR types, how often respondents state they document a specific type of NFR when they also state that it is important. This allows us to quantify the occurrence of potential Technical Debt and Waste. Results: Based on 398 survey responses, four NFR types (Maintainability, Reliability, Usability, and Performance) are labelled as important but they are not documented by more than 22% of the respondents. We interpret that these NFR types have a higher risk of Technical Debt than other NFR types. Regarding Waste, 15% of the respondents state they document NFRs related to Security and they do not consider it important. Conclusions: There is a clear indication that there is a risk of Technical Debt for a fixed set of NFRs since there is a lack of documentation of important NFRs. The potential risk of incurring Waste is also present but to a lesser extent

    Trends in multiple recurrent health complaints in 15-year-olds in 35 countries in Europe, North America and Israel from 1994 to 2010

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    Publisher Copyright: © 2015 The Author. Published by Oxford University Press on behalf of the European Public Health Association. All rights reserved.Background: Health complaints are a good indicator of an individual's psychosocial health and well-being. Studies have shown that children and adolescents report health complaints which can cause significant individual burden. Methods: Using data from the international Health Behaviour in School-aged Children study, this article describes trends in multiple recurrent health complaints (MHC) in 35 countries among N = 237 136 fifteen-year-olds from 1994 to 2010. MHC was defined as the presence of two or more health complaints at least once a week. Logistic regression analysis was performed to evaluate trends across the five survey cycles for each country. Results: Lowest prevalence throughout the period 1994-2010 was 16.9% in 1998 in Austria and highest in 2006 in Israel (54.7%). Overall, six different trend patterns could be identified: No linear or quadratic trend (9 countries), linear decrease (7 countries), linear increase (5 countries), U-shape (4 countries), inverted U-shape (6 countries) and unstable (4 countries). Conclusion: Trend analyses are valuable in providing hints about developments in populations as well as for benchmarking and evaluation purposes. The high variation in health complaints between the countries requires further investigation, but may also reflect the subjective nature of health complaints.publishersversionPeer reviewe

    Living with a long-term condition: understanding well-being for individuals with thrombophilia or asthma

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    range of literature has explored the experience of living with a long-term condition (LTC), and frequently treats such experiences and conditions as problematic. In contrast, other research has demonstrated that it may be possible to adapt and achieve well-being, even when living with such a condition. This tends to focus on meaning and the qualitative experience of living with an LTC, and offers alternative perspectives, often of the same or similar conditions. As a result of these conflicting views, this study chose to consider two conditions which, though they may lead to life-threatening illness on occasion, do not appear to impact significantly the lives of all those affected on a daily basis. The aim of this research was to explore and explain how people make sense of two long-term, potentially life-threatening health conditions, namely, thrombophilia and asthma. In doing so, it specifically considered the contribution made by information about the condition. A constructivist grounded theory approach was adopted; this enabled the generation of a theory regarding how people make sense of their LTC, whilst acknowledging the social circumstances in which this was situated. Semi-structured interviews were conducted with 16 participants who had given consent to take part in the research. The findings demonstrate that participants undergo a two-stage process * gaining knowledge and living with a long-term condition . The theory based on these findings indicates that those who are knowledgeable about their condition, making informed decisions in relation to it, and accept their condition are able to live with it, whilst those who do not accept their condition do not fully adapt to it or integrate it into their live

    Autologous stem cell transplantation with low-dose cyclophosphamide to improve mucosal healing in adults with refractory Crohn's disease: the ASTIClite RCT

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    Some text in this abstract has been reproduced from Lindsay J, Din S, Hawkey C, Hind D, Irving P, Lobo A, et al. OFR-9 An RCT of autologous stem-cell transplantation in treatment refractory Crohn’s disease (low-intensity therapy evaluation): ASTIClite. Gut 2021;70(Suppl. 4):A4. Background Treatment-refractory Crohn’s disease is characterised by chronic symptoms, poor quality of life and high costs to the NHS, and through days of work lost by patients. A previous trial of autologous haematopoietic stem cell transplant (HSCT) failed its end point of medication-free clinical remission for 3 months with no evidence of disease activity, and reported high toxicity. Subsequent studies suggest that HSCT achieves complete mucosal healing in 50% of patients, and that toxicity likely relates to the cyclophosphamide dose. Objectives The primary objective was to assess the efficacy of HSCTlite (HSCT with low-dose cyclophosphamide) compared with standard care for inducing regression of intestinal ulceration in patients with refractory Crohn’s disease at week 48. Secondary objectives included the assessment of disease activity, quality of life and regimen safety. Mechanistic objectives included immune reconstitution after HSCTlite. Design Two-arm, parallel-group randomised controlled trial with a 2 : 1 (intervention : control) allocation ratio. Setting Nine NHS trusts (eight trusts were recruitment sites; one trust was a treatment-only site). Participants Adults with treatment-refractory Crohn’s disease, for whom surgery was inappropriate or who had declined surgery. Interventions The intervention treatment was HSCTlite using cyclophosphamide, and the control was any current available treatment for Crohn’s disease, apart from stem cell transplantation. Main outcomes The primary outcome was treatment success at week 48 [mucosal healing (Simple Endoscopic Score for Crohn’s Disease ulcer subscore of 0) without surgery or death], assessed by central readers blinded to allocation and timing of assessment. Key secondary outcomes were clinical remission, Simple Endoscopic Score for Crohn’s Disease scores at week 48, change in Crohn’s Disease Activity Index scores and safety. Results The trial was halted owing to Suspected unexpected serious adverse events that took place after randomising 23 patients (HSCTlite arm, n = 13; usual-care arm, n = 10). Ten out of the 13 patients randomised to the HSCTlite arm received the intervention and nine (one death) reached the 48-week follow-up. In the usual-care arm 9 out of the 10 patients randomised reached the 48-week follow-up (one ineligible). The primary outcome was available for 7 out of 10 HSCTlite patients (including the patient who died) and six out of nine usual-care patients. Absence of endoscopic ulceration without surgery or death was reported in three out of seven (43%) HSCTlite patients, compared with zero out of six (0%) usual-care patients. Centrally read Simple Endoscopic Score for Crohn’s Disease scores [mean (standard deviation)] were 10.8 (6.3) and 10.0 (6.1) at baseline, compared with 2.8 (2.9) and 18.7 (9.1) at week 48, in the HSCT and usual-care arms, respectively. Clinical remission (Crohn’s Disease Activity Index scores of < 150) occurred in 57% and 17% of patients in the HSCTlite and usual-care arms, respectively, at week 48. Serious adverse events were more frequent in the HSCTlite arm [38 in 13 (100%) patients] than in the usual-care arm [16 in 4 (40%) patients]. Nine suspected unexpected serious adverse reactions were reported in six HSCTlite patients, including three cases of delayed renal failure due to proven thrombotic microangiopathy. Two HSCTlite patients died. Conclusions Within the limitations of reduced patient recruitment and numbers of patients assessed, HSCTlite meaningfully reduced endoscopic disease activity, with three patients experiencing resolution of ulceration. Suspected unexpected serious adverse reactions, particularly relating to thrombotic microangiopathy, make this regimen unsuitable for future clinical use. Limitations The early trial closure prevented complete recruitment, and the impact of the coronavirus pandemic prevented completion of some study investigations. Small participant numbers meant analysis could only be descriptive. Future work Owing to undetermined aetiology of thrombotic microangiopathy, further trials of HSCTlite in this population are not considered appropriate. Priorities should be to determine optimal treatment strategies for patients with refractory Crohn’s disease, including those with a stoma or multiple previous resections

    Arctic hydroclimate variability during the last 2000 years : current understanding and research challenges

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    Reanalysis data show an increasing trend in Arctic precipitation over the 20th century, but changes are not homogenous across seasons or space. The observed hydro-climate changes are expected to continue and possibly accelerate in the coming century, not only affecting pan-Arctic natural ecosystems and human activities, but also lower latitudes through the atmospheric and ocean circulations. However, a lack of spatiotemporal observational data makes reliable quantification of Arctic hydroclimate change difficult, especially in a long-term context. To understand Arctic hydroclimate and its variability prior to the instrumental record, climate proxy records are needed. The purpose of this review is to summarise the current understanding of Arctic hydroclimate during the past 2000 years. First, the paper reviews the main natural archives and proxies used to infer past hydroclimate variations in this remote region and outlines the difficulty of disentangling the moisture from the temperature signal in these records. Second, a comparison of two sets of hydroclimate records covering the Common Era from two data-rich regions, North America and Fennoscandia, reveals inter- and intra-regional differences. Third, building on earlier work, this paper shows the potential for providing a high-resolution hydroclimate reconstruction for the Arctic and a comparison with last-millennium simulations from fully coupled climate models. In general, hydroclimate proxies and simulations indicate that the Medieval Climate Anomaly tends to have been wetter than the Little Ice Age (LIA), but there are large regional differences. However, the regional coverage of the proxy data is inadequate, with distinct data gaps in most of Eurasia and parts of North America, making robust assessments for the whole Arctic impossible at present. To fully assess pan-Arctic hydroclimate variability for the last 2 millennia, additional proxy records are required.Peer reviewe

    Characterizing the conformational dynamics of metal-free PsaA using molecular dynamics simulations and electron paramagnetic resonance spectroscopy

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    Prokaryotic metal-ion receptor proteins, or solute-binding proteins, facilitate the acquisition of metal ions from the extracellular environment. Pneumococcal surface antigen A (PsaA) is the primary Mn2+-recruiting protein of the human pathogen Streptococcus pneumoniae and is essential for its in vivo colonization and virulence. The recently reported high-resolution structures of metal- free and metal-bound PsaA have provided the first insights into the mechanism of PsaA-facilitated metal binding. However, the conformational dynamics of metal-free PsaA in solution remain unknown. Here, we use continuous wave electron paramagnetic resonance (EPR) spectroscopy and molecular dynamics (MD) simulations to study the relative flexibility of the structural domains in metal-free PsaA and its distribution of conformations in solution. The results show that the crystal structure of the metal-free PsaA is a good representation of the dominant conformation in solution, but the protein also samples structurally distinct conformations that are not captured by the crystal structure. Further, these results suggest that the metal binding site is larger and more solvent exposed than indicated by the metal-free crystal structure. Collectively, this study provides atomic-resolution insight into the conformational dynamics of PsaA prior to metal binding and lays the groundwork for future EPR and MD based studies of PsaA in solution
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