283 research outputs found
Cost and benefit analysis of quality requirements in competitive software product management: a case study on the QUPER model
In market-driven product development, it is important that the software product is released to the market at the right time, and offers higher quality than the competitors. In release planning, the allocation of development effort in investments into product enhancements, functions are competing with quality requirements for limited resources. In addition, it is important to find the right balance between competing quality requirements. In this paper, we present an industrial evaluation of the benefit and cost views in the QUality PERformance (QUPER) model. The results indicate that the model is relevant in the release planning process, and that the combination of the benefit and cost views provides a clear picture of the current market situation
A Case Study Evaluation of the Guideline-Supported QUPER Model for Elicitation of Quality Requirements
[Context & motivation] For market-driven software product developing organizations operating on a competitive open market, it is important to plan the productâs 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
Expression of Cartilage Oligomeric Matrix Protein in colorectal cancer is an adverse prognostic factor and correlates negatively with infiltrating immune cells and PD-L1 expression
IntroductionCartilage Oligomeric Matrix Protein (COMP) is an oncogenic protein that has been associated with a decrease in infiltrating T-cells in periampullary adenocarcinoma. This study aimed to investigate whether this is also the case for colorectal cancer (CRC) and to evaluate the relationship between COMP expression and clinopathological features.MethodsImmunohistochemistry was used to determine the expression levels of COMP in tumor cells and stroma in primary tumors from a cohort of 537 CRC patients. The expression of immune cell markers, including CD3+, CD8+, FoxP3+, CD68+, CD56+, CD163+, and PD-L1, was evaluated previously. Tumor fibrosis was assessed by Sirius Red staining and evaluation of collagen fiber organization.ResultsCOMP expression correlated positively with TNM-stage and grade of differentiation. Patients with CRC expressing high levels of COMP had significantly shorter OS than those with low COMP expression (p<0.0001), and fewer infiltrating T-cells were detected in tumors with high COMP expression. Additionally, a negative correlation was identified between the expression of COMP and PD-L1 on both tumor cells and immune cells. Cox regression analysis showed that tumors expressing high levels of COMP had significantly shorter OS, independent of all evaluated immune cell markers. Tumor fibrosis was correlated with high expression of COMP in the stroma (p<0.0001), and tumors with high levels of COMP expression and denser fibrosis displayed more sparse immune cell infiltration.DiscussionThe results suggest that COMP expression in CRC may exert an immune regulatory effect by increasing dense fibrosis and decreasing immune cell infiltration. These findings support the notion that COMP is an important factor in the development and progression of CRC
Barriers and facilitators to faecal immunochemical testing in symptomatic populations: a rapid systematic scoping review and gap analysis
Aim
Faecal immunochemical testing (FIT) is used to triage people with signs or symptoms of a colorectal cancer (CRC). Recent guidelines have recommended further research to improve access, uptake and return of FIT. This systematic scoping review aims to understand the barriers and facilitators to FIT testing in symptomatic patients.
Method
Qualitative, quantitative and mixed-methods studies published after September 2013 were included. MEDLINE, EMBASE and PsycINFO databases were searched to identify publications examining barriers and facilitators to FIT. Initially, the data underwent thematic analysis, and subsequently, factors were aligned to components of the Capability, Opportunity, Motivation, Behaviour model. All outcomes are presented in adherence to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.
Results
One thousand two hundred thirty-two papers were identified; 11 met the inclusion criteria. Barriers and facilitators were identified at the patient (e.g., knowledge), provider (e.g., general practitioner awareness) and service level (e.g., method of providing FIT kits). Factors were categorised into the subcomponents of the model: psychological capability (e.g., lack of FIT knowledge), reflective motivation (e.g., beliefs regarding FIT sampling and faeces being unhygienic) and automatic motivation (e.g., embarrassment, scary, anxiety provoking). Gaps in knowledge emerged in three domains: (1) patient experience, (2) FIT pathway and (3) healthcare professionals experience of FIT.
Conclusion
This systematic scoping review provides a summary of the literature on FIT uptake, and identified factors across multiple levels and components. To increase adherence to FIT completion within primary care, a multifaceted theory and evidence-based approach is needed to underpin future behavioural science interventions
Technical debt and waste in non-functional requirements documentation:an exploratory study
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
Living with a long-term condition: understanding well-being for individuals with thrombophilia or asthma
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
Arctic hydroclimate variability during the last 2000 years : current understanding and research challenges
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
Autologous stem cell transplantation with low-dose cyclophosphamide to improve mucosal healing in adults with refractory Crohn's disease: the ASTIClite RCT
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 Crohnâs disease (low-intensity therapy evaluation): ASTIClite. Gut 2021;70(Suppl. 4):A4.
Background
Treatment-refractory Crohnâs 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 Crohnâs 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 2â:â1 (interventionâ:âcontrol) allocation ratio.
Setting
Nine NHS trusts (eight trusts were recruitment sites; one trust was a treatment-only site).
Participants
Adults with treatment-refractory Crohnâs 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 Crohnâs disease, apart from stem cell transplantation.
Main outcomes
The primary outcome was treatment success at week 48 [mucosal healing (Simple Endoscopic Score for Crohnâs 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 Crohnâs Disease scores at week 48, change in Crohnâs 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, nâ=â13; usual-care arm, nâ=â10). 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 Crohnâs 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 (Crohnâs Disease Activity Index scores of <â150) 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 Crohnâs disease, including those with a stoma or multiple previous resections
Flexor Injury Rehabilitation Splint Trial (FIRST): protocol for a pragmatic randomised controlled trial comparing three splints for finger flexor tendon repairs
Background
Without surgical repair, flexor tendon injuries do not heal and patientsâ ability to bend fingers and grip objects is impaired. However, flexor tendon repair surgery also requires optimal rehabilitation. There are currently three custom-made splints used in the rehabilitation of zone I/II flexor tendon repairs, each with different assumed harm/benefit profiles: the dorsal forearm and hand-based splint (long), the Manchester short splint (short), and the relative motion flexion splint (mini). There is, however, no robust evidence as to which splint, if any, is most clinical or cost effective. The Flexor Injury Rehabilitation Splint Trial (FIRST) was designed to address this evidence gap.
Methods
FIRST is a parallel group, superiority, analyst-blind, multi-centre, individual participant-randomised controlled trial. Participants will be assigned 1:1:1 to receive either the long, short, or mini splint. We aim to recruit 429 participants undergoing rehabilitation following zone I/II flexor tendon repair surgery. Potential participants will initially be identified prior to surgery, in NHS hand clinics across the UK, and consented and randomised at their splint fitting appointment post-surgery. The primary outcome will be the mean post-randomisation score on the patient-reported wrist and hand evaluation measure (PRWHE), assessed at 6, 12, 26, and 52 weeks post randomisation. Secondary outcome measures include blinded grip strength and active range of movement (AROM) assessments, adverse events, adherence to the splinting protocol (measured via temperature sensors inserted into the splints), quality of life assessment, and further patient-reported outcomes. An economic evaluation will assess the cost-effectiveness of each splint, and a qualitative sub-study will evaluate participantsâ preferences for, and experiences of wearing, the splints. Furthermore, a mediation analysis will determine the relationship between patient preferences, splint adherence, and splint effectiveness.
Discussion
FIRST will compare the three splints with respect to clinical efficacy, complications, quality of life and cost-effectiveness. FIRST is a pragmatic trial which will recruit from 26 NHS sites to allow findings to be generalisable to current clinical practice in the UK. It will also provide significant insights into patient experiences of splint wear and how adherence to splinting may impact outcomes.
Trial registration
ISRCTN: 1023601
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