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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 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.

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.

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.

Transcranial direct current stimulation (tDCS) is a non-invasive form of neurostimulation with potential for development as a self-administered intervention. It has shown promise as a safe and effective treatment for obsessive compulsive disorder (OCD) in a small number of studies. The two most favourable stimulation targets appear to be the left orbitofrontal cortex (L-OFC) and the supplementary motor area (SMA). We report the first study to test these targets head-to-head within a randomised sham-controlled trial. Our aim was to inform the design of future clinical research studies, by focussing on the acceptability and safety of the intervention, feasibility of recruitment, adherence to and tolerability of tDCS, and the size of any treatment-effect. FEATSOCS was a randomised, double-blind, sham-controlled, cross-over, multicentre study. Twenty adults with DSM-5-defined OCD were randomised to treatment, comprising three courses of clinic-based tDCS (SMA, L-OFC, Sham), randomly allocated and delivered in counterbalanced order. Each course comprised four 20-min 2 mA stimulations, delivered over two consecutive days, separated by a ‘washout’ period of at least four weeks. Assessments were carried out by raters who were blind to stimulation-type. Clinical outcomes were assessed before, during, and up to four weeks after stimulation. Patient representatives with lived experience of OCD were actively involved at all stages. Clinicians showed willingness to recruit participants and recruitment to target was achieved. Adherence to treatment and study interventions was generally good, with only two dropouts. There were no serious adverse events, and adverse effects which did occur were transient and mostly mild in intensity. Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) scores were numerically improved from baseline to 24 h after the final stimulation across all intervention groups but tended to worsen thereafter. The greatest effect size was seen in the L-OFC arm, (Cohen's d = −0.5 [95% CI −1.2 to 0.2] versus Sham), suggesting this stimulation site should be pursued in further studies. Additional significant sham referenced improvements in secondary outcomes occurred in the L-OFC arm, and to a lesser extent with SMA stimulation. tDCS was acceptable, practicable to apply, well-tolerated and appears a promising potential treatment for OCD. The L-OFC represents the most promising target based on clinical changes, though the effects on OCD symptoms were not statistically significant compared to sham. SMA stimulation showed lesser signs of promise. Further investigation of tDCS in OCD is warranted, to determine the optimal stimulation protocol (current, frequency, duration), longer-term effectiveness and brain-based mechanisms of effect. If efficacy is substantiated, consideration of home-based approaches represents a rational next step. Trial registration: ISRCTN17937049. https://doi.org/10.1186/ISRCTN17937049 •Transcranial Direct Current Stimulation (tDCS) is acceptable and safe for use by patients with OCD•Active stimulation produced short-lived improvement in OCD symptoms and mood versus sham•tDCS targeting the left orbitofrontal cortex (L-OFC) produced the largest symptom-change

This study aimed to analyze and evaluate the influence of array losses on the financial sustainability and economic viability of wind farm projects with a capacity of 100 MW. The Al-Fajer site has been proposed for a feasibility study to assess the viability of building an onshore wind farm. The assessment of investment costs was conducted using the RETScreen program. The findings demonstrated that alterations in array losses impact the amount of energy exported to the grid, influencing changes in revenue, pre-tax internal rate of return (IRR), and net present value (NPV). When array losses in (case 1) decrease by 2%, that will positively impact financial feasibility factors. Therefore, it will lead to a gain in income for all turbines; the net present value (NPV) and pre-tax internal rate of return (IRR) values experienced an increase, indicating a positive impact on the project’s profitability. When array losses in (case 2) increase by 2%, it will lead to negative results on the wind farm and, thus, reduce the energy exported to the grid; wind turbine revenue will experience a decline. This increase substantially affects the NPV and IRR, leading to decreases. The capacity factor experienced a drop, resulting in significant changes to the project’s financial returns. The levelized cost of energy (LCOE) has increased due to decreased production, leading to higher prices. The simple payback likewise experienced a boost beyond its usual norms.

Background Evaluations of complex interventions in public health are frequently undermined by problems that can be identified before the effectiveness study stage. Exploratory studies, often termed pilot and feasibility studies, are a key step in assessing the feasibility and value of progressing to an effectiveness study. Such studies can provide vital information to support more robust evaluations, thereby reducing costs and minimising potential harms of the intervention. This systematic review forms the first phase of a wider project to address the need for stand-alone guidance for public health researchers on designing and conducting exploratory studies. The review objectives were to identify and examine existing recommendations concerning when such studies should be undertaken, questions they should answer, suitable methods, criteria for deciding whether to progress to an effectiveness study and appropriate reporting. Methods We searched for published and unpublished guidance reported between January 2000 and November 2016 via bibliographic databases, websites, citation tracking and expert recommendations. Included papers were thematically synthesized. Results The search retrieved 4095 unique records. Thirty papers were included, representing 25 unique sources of guidance/recommendations. Eight themes were identified: pre-requisites for conducting an exploratory study, nomenclature, guidance for intervention assessment, guidance surrounding any future evaluation study design, flexible versus fixed design, progression criteria to a future evaluation study, stakeholder involvement and reporting of exploratory studies. Exploratory studies were described as being concerned with the intervention content, the future evaluation design or both. However, the nomenclature and endorsed methods underpinning these aims were inconsistent across papers. There was little guidance on what should precede or follow an exploratory study and decision-making surrounding this. Conclusions Existing recommendations are inconsistent concerning the aims, designs and conduct of exploratory studies, and guidance is lacking on the evidence needed to inform when to proceed to an effectiveness study. Trial registration PROSPERO 2016, CRD42016047843

ObjectiveLittle is known about the lived experiences of patients with metastatic melanoma undergoing checkpoint inhibitor treatment. We conducted a feasibility study of a supportive care intervention for melanoma patients being treated with pembrolizumab. Here, we report a secondary objective of the study, which was to explore the lived experience of being on pembrolizumab treatment for advanced melanoma.MethodsTwenty-eight participants with metastatic melanoma were recruited across two cohorts, all receiving 3-weekly immunotherapy treatment. Semi-structured interviews were conducted with 26 participants once at 9 weeks. Thematic analysis using interpretative phenomenological analysis (IPA) was performed with multiple iterations of data review to achieve consensus.ResultsThree overarching themes were identified; here, we report the first and most dominant theme: how metastatic melanoma patients live within uncertain spaces. Although immunotherapy increases overall survival, metastatic melanoma patients live within an uncertain spectrum. They confront uncertainty related to immunotherapy treatment, their disease trajectory, family relationships, and decision-making. Melanoma patients attempt to normalize their lives, engaging in their usual activities. Uncertainty increases prior to active treatment and intensifies during investigation phases.ConclusionsDespite progress in melanoma patient treatment and outcomes, these patients face sustained uncertainty about their disease trajectory.