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Background Implementation trials aim to test the effects of implementation strategies on the adoption, integration or uptake of an evidence-based intervention within organisations or settings. Feasibility and pilot studies can assist with building and testing effective implementation strategies by helping to address uncertainties around design and methods, assessing potential implementation strategy effects and identifying potential causal mechanisms. This paper aims to provide broad guidance for the conduct of feasibility and pilot studies for implementation trials. Methods We convened a group with a mutual interest in the use of feasibility and pilot trials in implementation science including implementation and behavioural science experts and public health researchers. We conducted a literature review to identify existing recommendations for feasibility and pilot studies, as well as publications describing formative processes for implementation trials. In the absence of previous explicit guidance for the conduct of feasibility or pilot implementation trials specifically, we used the effectiveness-implementation hybrid trial design typology proposed by Curran and colleagues as a framework for conceptualising the application of feasibility and pilot testing of implementation interventions. We discuss and offer guidance regarding the aims, methods, design, measures, progression criteria and reporting for implementation feasibility and pilot studies. Conclusions This paper provides a resource for those undertaking preliminary work to enrich and inform larger scale implementation trials.

Background Cancer cachexia is a prevalent symptom of head and neck neoplasms. The reduction in skeletal muscle mass is one of the main characteristics which can lead to poor physical functioning. The purposes of this pilot randomized controlled trial were to determine the feasibility of progressive resistance training in cachectic head and neck cancer patients during radiotherapy and to explore possible risks and benefits. Methods Twenty cachectic participants with head and neck cancer receiving radiation were randomized to obtain either a machine supported progressive resistance training ( n  = 10) or usual care (n = 10). The training took place 3 times weekly for 30 min. Intervention included 3 exercises for major muscle groups with 8–12 repetition maximum for 3 sets each. Bioelectrical impedance analysis, hand-held dynamometry, Six-Minute Walk Test and standardized questionnaires for fatigue and quality of life were used for evaluating outcomes at baseline before radiotherapy (t1), after 7 weeks of radiotherapy (t2) and 8 weeks after the end of radiotherapy (t3). Results All participants ( n  = 20) completed the trial. No serious adverse events occurred. At the initial assessment the cachectic patients had already lost 7.1 ± 5.2% of their body weight. General fatigue (score 10.7 ± 3.3) and reduced quality of life (score 71.3 ± 20.6) were prevalent in cachectic head and neck cancer patients even before radiotherapy. An average improvement of weight loading for leg press (+ 19.0%), chest press (+ 29.8%) and latissimus pull-down (+ 22.8%) was possible in the intervention group. Participants had at least 13 training sessions. The outcome measures showed nonsignificant changes at t2 and t3, but a trend for a better course of general fatigue and quality of life at t2 in the intervention group. Conclusions Despite advanced tumor stage and burdensome treatment the intervention adherence is excellent. Progressive resistance training in cachectic head and neck cancer patients during radiotherapy seems to be safe and feasible and may have beneficial effects of general fatigue and quality of life. Trial registration ClinicalTrials.gov, NCT03524755 . Registered 15 May 2018 - Retrospectively registered.

Background Perioperative FLOT (5-fluorouracil, oxaliplatin and docetaxel) has recently become the gold standard treatment for fit patients with operable gastric (GC) or gastroesophageal (GEJ) adenocarcinoma, getting a 5-year overall survival (OS) of 45%, over 23% with surgery alone. Methods RealFLOT is an Italian, multicentric, observational trial, collecting data from patients with resectable GC or GEJ adenocarcinoma treated with perioperative FLOT. Aim of the study was to describe feasibility and safety of FLOT, pathological complete response rate (pCR), surgical outcomes and overall response rate (ORR) in an unselected real-world population. Additional analyses evaluated the correlation between pCR and survival and the prognostic role of microsatellite instability (MSI) status. Results Of 206 patients enrolled that received perioperative FLOT at 15 Italian centers, 124 (60.2%) received at least 4 full-dose cycles, 190 (92.2%) underwent surgery, and 142 (68.9%) started the postoperative phase. Among patients who started the postoperative phase, 105 (51.0%) received FLOT, while 37 (18%) received de-intensified regimens, depending on clinical condition or previous toxicities. pCR was achieved in 7.3% of cases. Safety profile was consistent with literature. Neutropenia was the most common G 3–4 adverse event (AE): 19.9% in the preoperative phase and 16.9% in the postoperative phase. No toxic death was observed and 30-day postoperative mortality rate was 1.0%. ORR was 45.6% and disease control rate (DCR) was 94.2%. Disease-free survival (DFS) and OS were significantly longer in case of pCR ( p  = 0.009 and p  = 0.023, respectively). A trend towards better DFS was observed among MSI-H patients. Conclusions These real-world data confirm the feasibility of FLOT in an unselected population, representative of the clinical practice. pCR rate was lower than expected, nevertheless we confirm pCR as a predictive parameter of survival. In addition, MSI-H status seems to be a positive prognostic marker also in patients treated with taxane-containing triplets.

Venous thromboembolism (VTE) diagnosis would greatly benefit from the identification of novel biomarkers to complement D-dimer, a marker limited by low specificity. Neutrophil extracellular traps (NETs) have been shown to promote thrombosis and could hypothetically be used for diagnosis of acute VTE. To assess the levels of specific markers of neutrophil activation and NETs and compare their diagnostic accuracy to D-dimer. We measured plasma levels of neutrophil activation marker neutrophil elastase (NE), the NET marker nucleosomal citrullinated histone H3 (H3Cit-DNA) and cell-free DNA in patients (n = 294) with suspected VTE (pulmonary embolism and deep vein thrombosis) as well as healthy controls (n = 30). A total of 112 VTE positive and 182 VTE negative patients from two prospective cohort studies were included. Higher levels of H3Cit-DNA and NE, but not cell-free DNA, were associated with VTE. Area under receiver operating curves (AUC) were 0.90 and 0.93 for D-dimer, 0.65 and 0.68 for NE and 0.60 and 0.67 for H3Cit-DNA in the respective cohorts. Adding NE and H3Cit-DNA to a D-dimer based risk model did not improve AUC. Our study demonstrates the presence of neutrophil activation and NET formation in VTE using specific markers. However, the addition of NE or H3Cit-DNA to D-dimer did not improve the discrimination compared to D-dimer alone. This study provides information on the feasibility of using markers of NETs as diagnostic tools in acute VTE. Based on our findings, we believe the potential of these markers are limited in this setting.

Successful management of chronic diseases requires a trustful collaboration between health care professionals, patients, and family members. Scalable conversational agents, designed to assist health care professionals, may play a significant role in supporting this collaboration in a scalable way by reaching out to the everyday lives of patients and their family members. However, to date, it remains unclear whether conversational agents, in such a role, would be accepted and whether they can support this multistakeholder collaboration. With asthma in children representing a relevant target of chronic disease management, this study had the following objectives: (1) to describe the design of MAX, a conversational agent-delivered asthma intervention that supports health care professionals targeting child-parent teams in their everyday lives; and (2) to assess the (a) reach of MAX, (b) conversational agent-patient working alliance, (c) acceptance of MAX, (d) intervention completion rate, (e) cognitive and behavioral outcomes, and (f) human effort and responsiveness of health care professionals in primary and secondary care settings. MAX was designed to increase cognitive skills (ie, knowledge about asthma) and behavioral skills (ie, inhalation technique) in 10-15-year-olds with asthma, and enables support by a health professional and a family member. To this end, three design goals guided the development: (1) to build a conversational agent-patient working alliance; (2) to offer hybrid (human- and conversational agent-supported) ubiquitous coaching; and (3) to provide an intervention with high experiential value. An interdisciplinary team of computer scientists, asthma experts, and young patients with their parents developed the intervention collaboratively. The conversational agent communicates with health care professionals via email, with patients via a mobile chat app, and with a family member via SMS text messaging. A single-arm feasibility study in primary and secondary care settings was performed to assess MAX. Results indicated an overall positive evaluation of MAX with respect to its reach (49.5%, 49/99 of recruited and eligible patient-family member teams participated), a strong patient-conversational agent working alliance, and high acceptance by all relevant stakeholders. Moreover, MAX led to improved cognitive and behavioral skills and an intervention completion rate of 75.5%. Family members supported the patients in 269 out of 275 (97.8%) coaching sessions. Most of the conversational turns (99.5%) were conducted between patients and the conversational agent as opposed to between patients and health care professionals, thus indicating the scalability of MAX. In addition, it took health care professionals less than 4 minutes to assess the inhalation technique and 3 days to deliver related feedback to the patients. Several suggestions for improvement were made. This study provides the first evidence that conversational agents, designed as mediating social actors involving health care professionals, patients, and family members, are not only accepted in such a \"team player\" role but also show potential to improve health-relevant outcomes in chronic disease management.

Chemical flooding is a crucial technique in petroleum recovery. Although synthetic polyacrylamides are widely used, they suffer from hard reservoir conditions (high salinity, temperature, and pressure) and high costs. Current efforts focus on eco-friendly and affordable biopolymers like xanthan gum to overcome these issues. This study screens xanthan gum modification to improve its rheological properties and tolerance to high temperature, salinity, and shearing action by copolymerizing it with vinyl silane, vinyl monomers, and silica nanoparticles. The new composite was characterized using Fourier Transform Infrared Spectroscopy (FTIR), Thermal Gravimetric Analysis (TGA), Atomic Force Microscopy (AFM), and proton Nuclear Magnetic Resonance (NMR) tests. Its implementation was evaluated in polymer flooding at 2200 psi pressure, 135,000 ppm salinity, and 196°F temperature. Unlike previous studies that evaluated xanthan gum at 176 °F, 1800 psi, and 30,000 ppm, without combining those three factors in one experiment. The rheological properties of native and composite xanthan were examined at reservoir conditions, as well as their viscoelastic properties (G′ and G″). Flooding runs used actual Bahariya formation cores at the lab scale. Simulation studies were conducted on a lab/field scale using the tNavigator simulator and economic feasibility to calculate the net present value. The most outcoming findings of this research comprise (1) investigating the impact of salinity, temperature, and pressure on the rheological properties of native and composite xanthan. (2) The composite xanthan exhibits more resistant criteria, as it recovered 27% residual oil versus 22% for native xanthan. (3) Modeling and simulation studies exhibit 48% oil recovery for composite versus 39% for native xanthan and 37% for water flooding. (4) Economically, using native and composite xanthan through enhanced oil recovery methods increased net present value to $32 mm and $58 mm versus traditional methods.

Protective factors that build students’ resilience are known. A six-week digital resilience training program was developed on the basis of theory, evidence, and contextual information. The feasibility study sought to evaluate the acceptability, appropriateness, demand, implementation, and limited efficacy of a digital resilience skills enhancement program for undergraduate students. A single group, pre-test, post-test, concurrent mixed methods design among 10 undergraduate students was conducted in one university in Singapore. The content analysis concluded that students accepted and perceived the digital resilience skills enhancement program as appropriate. Students also proposed several improvements, such as the initiation of the program and revisions to the content. The Wilcoxon signed-rank test found significant improvements in resilience (p = 0.02) and meta-cognitive self-regulation (p = 0.01) scores with medium (d = 0.79, 95% CI: −0.15 to 1.74) and very large effect sizes (d = 1.31, 95% CI: 0.30–2.33), respectively. Students found the digital resilience program appropriate and were able to apply their newly acquired skills to promote their resilience and learning. Although, several improvements are proposed to enhance the rigor of the digital resilience program, the findings of this study suggests that digital resilience programs are important for students’ well-being.

PurposePast research recommends integration of social sustainability (SS) considerations in construction project feasibility study for benefitting a larger group of project stakeholders. However, there is a lack of empirical evidence to this effect, especially from the developing economies. The purpose of this study is to address this knowledge gap through a SS-centric analysis of feasibility study reports using a stakeholder salience perspective.Design/methodology/approachFeasibility study reports for 61 projects were obtained from various government organizations in India. The SS considerations were identified in the reports using a combination of quantitative and qualitative assessments. The former was based on content analysis and the latter was conducted using “VOSviewer” text analysis software.FindingsSS considerations related to occupational health and safety, workers' employment practices and proactive involvement of communities and end-users were found to be inadequately addressed in the reports. Based on occurrences of the SS considerations, project-affected community was found to be the most salient stakeholder, followed by the end-users and the construction workers. Statistical analysis revealed significant relationship between the SS considerations and the type of project as well as the type of project delivery system.Originality/valueThis study contributes to better understanding of integrating SS considerations in feasibility study of construction projects. Its results provide useful inputs to decision-makers for orienting construction projects, right from the early phases, towards benefitting the disadvantaged and weaker stakeholders irrespective of their salience attributes. In developing economies, such interventions may improve quality of lives of a large number of project stakeholders and also cultivate a positive societal image of the construction industry as a respectful, ethical and employee friendly industry.

An essential step in any medical research project after identifying the research question is to determine if there are sufficient patients available for a study and where to find them. Pursuing digital feasibility queries on available patient data registries has proven to be an excellent way of reusing existing real-world data sources. To support multicentric research, these feasibility queries should be designed and implemented to run across multiple sites and securely access local data. Working across hospitals usually involves working with different data formats and vocabularies. Recently, the Fast Healthcare Interoperability Resources (FHIR) standard was developed by Health Level Seven to address this concern and describe patient data in a standardized format. The Medical Informatics Initiative in Germany has committed to this standard and created data integration centers, which convert existing data into the FHIR format at each hospital. This partially solves the interoperability problem; however, a distributed feasibility query platform for the FHIR standard is still missing. This study described the design and implementation of the components involved in creating a cross-hospital feasibility query platform for researchers based on FHIR resources. This effort was part of a large COVID-19 data exchange platform and was designed to be scalable for a broad range of patient data. We analyzed and designed the abstract components necessary for a distributed feasibility query. This included a user interface for creating the query, backend with an ontology and terminology service, middleware for query distribution, and FHIR feasibility query execution service. We implemented the components described in the Methods section. The resulting solution was distributed to 33 German university hospitals. The functionality of the comprehensive network infrastructure was demonstrated using a test data set based on the German Corona Consensus Data Set. A performance test using specifically created synthetic data revealed the applicability of our solution to data sets containing millions of FHIR resources. The solution can be easily deployed across hospitals and supports feasibility queries, combining multiple inclusion and exclusion criteria using standard Health Level Seven query languages such as Clinical Quality Language and FHIR Search. Developing a platform based on multiple microservices allowed us to create an extendable platform and support multiple Health Level Seven query languages and middleware components to allow integration with future directions of the Medical Informatics Initiative. We designed and implemented a feasibility platform for distributed feasibility queries, which works directly on FHIR-formatted data and distributed it across 33 university hospitals in Germany. We showed that developing a feasibility platform directly on the FHIR standard is feasible.

In this article, a technical–economic study has been displayed to evaluate the productivity of grid-connected photovoltaic (PV) solar system in a campus of University of Zakho, Iraq. The feasibility of this study is based on performance ratio, capacity factor, cost of energy and yield factor. The analysis of the system has been performed using System Advisor Model (SAM) software and real data of Zakho city that is available in national renewable energy laboratory (NREL). Results show that the system produces 5205 AC MWh during the year with a maximum power generated by the arrays equal to 3.15 AC MW. The yield factor from the proposed PV system for first year is 1554 kWh/kW, whereas the capacity factor nearly equal to 17.7%. Findings indicate that the cost of energy generated by the solar system is 6.3¢/kWh. The payback period to restore the cost of the government electrical energy without using the local electrical generators is 7 years while the payback period becomes 4 years when local electrical generators is used. Finally, results demonstrate that the investment in the technology of PV system is quite favourable in this site and hence, this article has a valuable information for those who wish to invest in PV technology in Iraq.