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Copia digital. Madrid : Instituto San Isidro de Madrid, 200

Staff perspectives on the feasibility of a clinical pathway for anxiety and depression in cancer care, and mid-implementation adaptations.

BACKGROUND: Clinical pathways (CPs) are intended to standardise and improve care but do not always produce positive outcomes, possibly because they were not adapted to suit the specific context in which they were enacted. This qualitative study aimed to explore staff perspectives of implementation of a CP for routine screening, assessment, referral and management of anxiety and depression (the ADAPT CP) for patients with cancer, focussing on perceived feasibility of the CP and negotiated adaptations made during the implementation phase. METHODS: The ADAPT CP was implemented in 12 urban and regional oncology services in Australia. Services were randomised to receive core versus enhanced implementation strategies. Core sites received support until implementation commencement and could access progress reports. Enhanced sites received proactive, ongoing support during the 12-month implementation. Purposively selected staff were interviewed prior to implementation (n = 88) and 6 months later, half-way through the implementation period (n = 89). Monthly meetings with lead multi-disciplinary teams at the eight enhanced sites were recorded. Data were thematically analysed. RESULTS: Six overarching themes were identified: ADAPT is of high value; timing for introducing the CP and screening is difficult; online screening is challenging; a burden too much; no-one to refer patients to; and micro-logistics are key. While early screening was deemed desirable, diverse barriers meant this was complex, with adaptations made to time and screening location. Online screening prompted by email, seen as time-saving and efficient, also proved unsuccessful in some services, with adaptations made to in-clinic or phone screening, or repeated email reminders. Staff negative attitudes to ADAPT, time constraints, and perceived poor fit of ADAPT to work roles and flows, all impacted implementation, with key tasks often devolving to a few key individuals. Nevertheless, services remained committed to the ADAPT CP, and worked hard to create, review and adapt strategies to address challenges to optimise success. CONCLUSIONS: This study demonstrates the interactive nature of health service change, with staff actively engaging with, forming views on, and problem-solving adaptations of the ADAPT CP to overcome barriers. Obtaining staff feedback is critical to ensure health service change is sustainable, meaningful and achieves its promise of improving patient outcomes. TRIAL REGISTRATION: The study was registered prospectively with the ANZCTR on 22/3/2017. Trial ID ACTRN12617000411347

The value of real-world testing: a qualitative feasibility study to explore staff and organisational barriers and strategies to support implementation of a clinical pathway for the management of anxiety and depression in adult cancer patients.

Background: Effective translation of evidence-based research into clinical practice requires assessment of the many factors that can impact implementation success. Research methods that draw on recognised implementation frameworks, such as the Promoting Action Research in Health Services (PARiHS) framework, and that test feasibility to gain information prior to full-scale roll-out, can support a more structured approach to implementation. Objective: This paper presents qualitative findings from a feasibility study in one cancer service of an online portal to operationalise a clinical pathway for the screening, assessment and management of anxiety and depression in adult cancer patients. The aim of this study was to explore staff perspectives on the feasibility and acceptance of a range of strategies to support implementation in order to inform the full-scale roll-out. Methods: Semi-structured interviews were conducted with fifteen hospital staff holding a range of clinical, administrative and managerial roles, and with differing levels of exposure to the pathway. Qualitative data were analysed thematically, and themes were subsequently organised within the constructs of the PARiHS framework. Results: Barriers and facilitators that affected the feasibility of the online portal and implementation strategies were organised across eight key themes: staff perceptions, culture, external influences, attitudes to psychosocial care, intervention fit, familiarity, burden and engagement. These themes mapped to the PARiHS framework's three domains of evidence, context and facilitation. Conclusions: Implementation success may be threatened by a range of factors related to the real-world context, perceptions of the intervention (evidence) and the process by which it is introduced (facilitation). Feasibility testing of implementation strategies can provide unique insights into issues likely to influence full-scale implementation, allowing for early tailoring and more effective facilitation which may save time, money and effort in the long-term. Use of a determinant implementation framework can assist researchers to synthesise and effectively respond to barriers as they arise. While the current feasibility study related to a specific implementation, strategies such as regular engagement with local stakeholders, and discussion of barriers arising in real-time during early testing is likely to be of benefit to all researchers and clinicians seeking to maximise the likelihood of long-term implementation success

How can we adapt complex population health interventions for new contexts? Progressing debates and research priorities

Introduction The UK Medical Research Council and National Institute for Health Research have funded the ADAPT study (2018–2020), to develop methodological guidance for the adaptation of complex population health interventions for new contexts. While there have been advances in frameworks, there are key theoretical and methodological debates to progress. The ADAPT study convened a panel meeting to identify and enrich these debates. This paper presents the panel’s discussions and suggests directions for future research. Methods Sixteen researchers and one policymaker convened for a 1-day meeting in July 2019. The aim was to reflect on emerging study findings (systematic review of adaptation guidance; scoping review of case examples; and qualitative interviews with funders, journal editors, researchers and policymakers), progress theoretical and methodological debates, and consider where innovation may be required to address research gaps. Discussion Despite the proliferation of adaptation frameworks, questions remain over the definition of basic concepts (eg, adaptation). The rationale for adaptation, which often focuses on differences between contexts, may lead to adaptation hyperactivity. Equal emphasis should be placed on similarities. Decision-making about intervention modification currently privileges the concept of ‘core components’, and work is needed to progress the use and operationalisation of ‘functional fidelity’. Language and methods must advance to ensure meaningful engagement with diverse stakeholders in adaptation processes. Further guidance is required to assess the extent of re-evaluation required in the new context. A better understanding of different theoretical perspectives, notably complex systems thinking, implementation science and realist evaluation may help in enhancing research on adaptation.The ADAPT Panel comprises of Laura Arnold, Julie Bishop, Andrew Booth, Lauren Copeland, Peter Craig, Frances Gardner, Penny Hawe, Pat Hoddinott, Frank Kee, Hannah Littlecott, Laurence Moore, Simon Murphy, Alicia O’ Cathai

El preceptor y su mujer : comedia en tres actos

En port.: "Representada en el Teatro de Variedades la noche del 11 de octubre de 1850"Núm. de serie en port.: "115"En prelim. consta que la obra "es propiedad de don Pablo Avecilla"Port. con viñeta xilH Ca. 104/00

Acceptability and appropriateness of a clinical pathway for managing anxiety and depression in cancer patients: a mixed methods study of staff perspectives.

BACKGROUND: Clinical pathways (CPs) can improve health outcomes, but to be sustainable, must be deemed acceptable and appropriate by staff. A CP for screening and management of anxiety and depression in cancer patients (the ADAPT CP) was implemented in 12 Australian oncology services for 12 months, within a cluster randomised controlled trial of core versus enhanced implementation strategies. This paper compares staff-perceived acceptability and appropriateness of the ADAPT CP across study arms. METHODS: Multi-disciplinary lead teams at each service tailored, planned, championed and implemented the CP. Staff at participating services, purposively selected for diversity, completed a survey and participated in an interview prior to implementation (T0), and at midpoint (6 months: T1) and end (12 months: T2) of implementation. Interviews were recorded, transcribed and thematically analysed. RESULTS: Seven metropolitan and 5 regional services participated. Questionnaires were completed by 106, 58 and 57 staff at T0, T1 and T2 respectively. Eighty-eight staff consented to be interviewed at T0, with 89 and 76 at T1 and T2 (response rates 70%, 66% and 57%, respectively). Acceptability/appropriateness, on the quantitative measure, was high at T0 (mean of 31/35) and remained at that level throughout the study, with no differences between staff from core versus enhanced services. Perceived burden was relatively low (mean of 11/20) with no change over time. Lowest scores and greatest variability pertained to perceived impact on workload, time and cost. Four major themes were identified: 1) Mental health is an important issue which ADAPT addresses; 2) ADAPT helps staff deliver best care, and reduces staff stress; 3) ADAPT is fit for purpose, for both cancer care services and patients; 4) ADAPT: a catalyst for change. Opposing viewpoints are outlined. CONCLUSIONS: This study demonstrated high staff-perceived acceptability and appropriateness of the ADAPT CP with regards to its focus, evidence-base, utility to staff and patients, and ability to create change. However, concerns remained regarding burden on staff and time commitment. Strategies from a policy and managerial level will likely be required to overcome the latter issues. TRIAL REGISTRATION: The study was registered prospectively with the ANZCTR on 22/3/2017. Trial ID ACTRN12617000411347. https://www.anzctr.org.au/

Long-term safety, tolerability, and efficacy of efgartigimod (ADAPT+): interim results from a phase 3 open-label extension study in participants with generalized myasthenia gravis

ObjectiveADAPT+ assessed the long-term safety, tolerability, and efficacy of efgartigimod in adult participants with generalized myasthenia gravis (gMG).MethodsADAPT+ was an open-label, single-arm, multicenter, up to 3-year extension of the pivotal phase 3 ADAPT study. Efgartigimod was administered in treatment cycles of 4 intravenous infusions (one 10 mg/kg infusion per week). Initiation of subsequent treatment cycles was individualized based on clinical evaluation. Safety endpoints included incidence and severity of adverse events. Efficacy endpoints assessed disease severity using Myasthenia Gravis-Activities of Daily Living (MG-ADL) and Quantitative Myasthenia Gravis (QMG) scores.ResultsAs of January 2022, 151 participants had rolled over to ADAPT+ and 145 had received ≥1 dose of efgartigimod, of whom, 111 (76.6%) were AChR-Ab+ and 34 (23.4%) were AChR-Ab−. Mean study duration (treatment plus follow-up) was 548 days, and participants received up to 17 treatment cycles, corresponding to 217.6 participant-years of exposure. In the overall population, 123 (84.8%) participants reported ≥1 treatment-emergent adverse event; most frequent were headache (36 [24.8%]), COVID-19 (22 [15.2%]), and nasopharyngitis (20 [13.8%]). Clinically meaningful improvement (CMI) in mean MG-ADL and QMG scores was seen as early as 1 week following the first infusion across multiple cycles in AChR-Ab+ and AChR-Ab− participants. Maximal MG-ADL and QMG improvements aligned with onset and magnitude of total IgG and AChR-Ab reductions. For AChR-Ab+ participants at any time point in each of the first 10 treatment cycles, more than 90% had a maximum reduction of ≥2 points (CMI) in MG-ADL total score; across the 7 cycles in which QMG was measured, 69.4% to 91.3% of participants demonstrated a maximum reduction of ≥3 points (CMI) in QMG total score. Many participants demonstrated improvements well beyond CMI thresholds. In AChR-Ab+ participants with ≥1 year of combined follow-up between ADAPT and ADAPT+, mean number of annualized cycles was 4.7 per year (median [range] 5.0 [0.5–7.6]).ConclusionResults of ADAPT+ corroborate the substantial clinical improvements seen with efgartigimod in ADAPT and support its long-term safety, tolerability, and efficacy, as well as an individualized dosing regimen for treatment of gMG.Clinical trial registrationhttps://classic.clinicaltrials.gov/ct2/show/NCT03770403, NCT03770403