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Psychology and Psychotherapy Mar 2024This paper outlines the theoretical and empirical basis for compassion focused therapy (CFT) for psychosis, the gaps in the current knowledge and research, as well as... (Review)
Review
PURPOSE
This paper outlines the theoretical and empirical basis for compassion focused therapy (CFT) for psychosis, the gaps in the current knowledge and research, as well as some of the challenges for addressing gaps. It will guide the direction of future work and the steps needed to develop and advance this approach.
METHOD
This paper reviews evidence of how evolutionary models such as social rank theory and attachment theory have greatly contributed to our understanding of psychosis and provide a clear rationale and evidence base for the mechanisms of change in CFT for psychosis. It reviews the evidence for outcomes of compassion training more generally, and early feasibility evaluations of CFT for psychosis.
RESULTS
The process evidence shows that people with psychosis have highly active social rank and threat systems, and the benefits of switching into attachment and care systems, which can support emotion regulation and integrative mind states. The outcomes evidence shows that compassion training impacts not only psychological outcomes, but also physiological outcomes such as neural circuits, immune system, and the autonomic nervous system. Within the psychosis field, outcomes research is still in the early days, but there are good indications of feasibility and a clear path forward for the next steps.
CONCLUSIONS
CFT for psychosis is an approach that integrates biopsychosocial processes, an integration that's evidenced across each aspect of the model, from theoretical foundations (evolution-informed) to interventions (e.g., body/breath training and relational techniques), to evaluation. Future RCTs are required to understand the effects on biopsychosocial outcomes for people with psychosis.
Topics: Humans; Empathy; Psychotic Disorders; Outcome Assessment, Health Care
PubMed: 37578215
DOI: 10.1111/papt.12490 -
International Journal of Environmental... Jan 2024Healthcare systems are transforming from the traditional volume-based model of healthcare to a value-based model of healthcare. Value generation in healthcare is about... (Review)
Review
Healthcare systems are transforming from the traditional volume-based model of healthcare to a value-based model of healthcare. Value generation in healthcare is about emphasising the health outcomes achieved by patients and organisations while maintaining an optimal relationship with costs. This scoping review aimed to identify the key elements and outcomes of implementing value-based healthcare (VBHC). The review process included studies published from 2013 to 2023 in four different databases (SpringerLink, PubMed, ProQuest and Scopus). Of the 2801 articles retrieved from the searches, 12 met the study's inclusion criteria. A total of 11 studies referred to value as the relationship between the outcomes achieved by patients and the costs of achieving those outcomes. Most of the studies highlighted the presence of leadership, the organisation of care into integrated care units, the identification and standardisation of outcome measures that generate value for the patient, and the inclusion of the patient perspective as the most prominent key elements for optimal VBHC implementation. Furthermore, some benefits were identified from VBHC implementation, which could shed light for future implementation actions. Therefore, the VBHC model is a promising approach that may contribute to an improvement in the efficiency and sustainability of healthcare.
Topics: Humans; Value-Based Health Care; Delivery of Health Care; Costs and Cost Analysis; Outcome Assessment, Health Care
PubMed: 38397625
DOI: 10.3390/ijerph21020134 -
Ultrasound in Obstetrics & Gynecology :... Sep 2023To develop a core set of prenatal and neonatal outcomes for clinical studies evaluating perinatal interventions for congenital diaphragmatic hernia, using a validated... (Review)
Review
OBJECTIVE
To develop a core set of prenatal and neonatal outcomes for clinical studies evaluating perinatal interventions for congenital diaphragmatic hernia, using a validated consensus-building method.
METHODS
An international steering group comprising 13 leading maternal-fetal medicine specialists, neonatologists, pediatric surgeons, patient representatives, researchers and methodologists guided the development of this core outcome set. Potential outcomes were collected through a systematic review of the literature and entered into a two-round online Delphi survey. A call was made for stakeholders with experience of congenital diaphragmatic hernia to review the list and score outcomes based on their perceived relevance. Outcomes that fulfilled the consensus criteria defined a priori were discussed subsequently in online breakout meetings. Results were reviewed in a consensus meeting, during which the core outcome set was defined. Finally, the definitions, measurement methods and aspirational outcomes were defined in online and in-person definition meetings by a selection of 45 stakeholders.
RESULTS
Overall, 221 stakeholders participated in the Delphi survey and 198 completed both rounds. Fifty outcomes met the consensus criteria and were discussed and rescored by 78 stakeholders in the breakout meetings. During the consensus meeting, 93 stakeholders agreed eventually on eight outcomes, which constituted the core outcome set. Maternal and obstetric outcomes included maternal morbidity related to the intervention and gestational age at delivery. Fetal outcomes included intrauterine demise, interval between intervention and delivery and change in lung size in utero around the time of the intervention. Neonatal outcomes included neonatal mortality, pulmonary hypertension and use of extracorporeal membrane oxygenation. Definitions and measurement methods were formulated by 45 stakeholders, who also added three aspirational outcomes: duration of invasive ventilation, duration of oxygen supplementation and use of pulmonary vasodilators at discharge.
CONCLUSIONS
We developed with relevant stakeholders a core outcome set for studies evaluating perinatal interventions in congenital diaphragmatic hernia. Its implementation should facilitate the comparison and combination of trial results, enabling future research to better guide clinical practice. © 2023 International Society of Ultrasound in Obstetrics and Gynecology.
Topics: Pregnancy; Female; Infant, Newborn; Child; Humans; Hernias, Diaphragmatic, Congenital; Research Design; Prenatal Care; Obstetrics; Outcome Assessment, Health Care; Delphi Technique; Treatment Outcome
PubMed: 37099763
DOI: 10.1002/uog.26235 -
Supportive Care in Cancer : Official... Jun 2023Patients with multiple myeloma experience severe symptom burden. Patient participation in self-reporting is essential as medical staff's assessment of patient symptom... (Review)
Review
BACKGROUND
Patients with multiple myeloma experience severe symptom burden. Patient participation in self-reporting is essential as medical staff's assessment of patient symptom severity is often lower than patient self-reporting. This article reviews patient-reported outcome (PRO) assessment tools and their application in the field of multiple myeloma.
RESULTS
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) is the universal patient-reported outcome assessment tool most frequently used to evaluate the life quality in people with multiple myeloma. Among the specific patient-reported outcome assessment tools, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Multiple Myeloma Module (EORTC QLQ-MY20), the Functional Assessment of Cancer Therapy-Multiple Myeloma (FACT-MM), and the M.D. Anderson Symptom Inventory-Multiple Myeloma Module (MDASI-MM) are the most widely used, with some scholars using the EORTC QLQ-MY20 as a calibration correlate for scale development. Most current assessment instruments were developed using classical measurement theory methods; future researchers could combine classic theory tests and item response theory to create scientific assessment instruments. In addition, researchers select the appropriate assessment tool based on the purpose of the study. They can translate high-quality assessment tools into different languages and consider applying them more often to assessing multiple myeloma patients. Finally, most existing PROs focus on measuring life quality and symptoms in people with multiple myeloma, with less research on outcomes such as adherence and satisfaction, thus failing to comprehensively evaluate the patient treatment and disease management.
CONCLUSIONS
Research has shown that the field of PROs in multiple myeloma is in an exploratory phase. There is still a need to enrich the content of PROs and develop more high-quality PRO scales for multiple myeloma based on the strengths and weaknesses of existing tools. With the successful advancement of information technology, PROs for people with multiple myeloma could be integrated with electronic information systems, allowing patients to report their health status in real time and doctors to track their condition and adjust their treatment, thereby improving patient outcomes.
Topics: Humans; Multiple Myeloma; Quality of Life; Patient Reported Outcome Measures; Patient Outcome Assessment; Disease Management
PubMed: 37389673
DOI: 10.1007/s00520-023-07902-4 -
Implementation Science : IS Jul 2023Proctor and colleagues' 2011 paper proposed a taxonomy of eight implementation outcomes and challenged the field to address a research agenda focused on... (Review)
Review
BACKGROUND
Proctor and colleagues' 2011 paper proposed a taxonomy of eight implementation outcomes and challenged the field to address a research agenda focused on conceptualization, measurement, and theory building. Ten years later, this paper maps the field's progress in implementation outcomes research. This scoping review describes how each implementation outcome has been studied, research designs and methods used, and the contexts and settings represented in the current literature. We also describe the role of implementation outcomes in relation to implementation strategies and other outcomes.
METHODS
Arksey and O'Malley's framework for conducting scoping reviews guided our methods. Using forward citation tracing, we identified all literature citing the 2011 paper. We conducted our search in the Web of Science (WOS) database and added citation alerts sent to the first author from the publisher for a 6-month period coinciding with the WOS citation search. This produced 1346 titles and abstracts. Initial abstract screening yielded 480 manuscripts, and full-text review yielded 400 manuscripts that met inclusion criteria (empirical assessment of at least one implementation outcome).
RESULTS
Slightly more than half (52.1%) of included manuscripts examined acceptability. Fidelity (39.3%), feasibility (38.6%), adoption (26.5%), and appropriateness (21.8%) were also commonly examined. Penetration (16.0%), sustainability (15.8%), and cost (7.8%) were less frequently examined. Thirty-two manuscripts examined implementation outcomes not included in the original taxonomy. Most studies took place in healthcare (45.8%) or behavioral health (22.5%) organizations. Two-thirds used observational designs. We found little evidence of progress in testing the relationships between implementation strategies and implementation outcomes, leaving us ill-prepared to know how to achieve implementation success. Moreover, few studies tested the impact of implementation outcomes on other important outcome types, such as service systems and improved individual or population health.
CONCLUSIONS
Our review presents a comprehensive snapshot of the research questions being addressed by existing implementation outcomes literature and reveals the need for rigorous, analytic research and tests of strategies for attaining implementation outcomes in the next 10 years of outcomes research.
Topics: Humans; Delivery of Health Care; Outcome Assessment, Health Care
PubMed: 37491242
DOI: 10.1186/s13012-023-01286-z -
Critical Care Clinics Jul 2023Critical care pharmacy has evolved rapidly over the last 50 years to keep pace with the rapid technological and knowledge advances that have characterized critical care... (Review)
Review
Critical care pharmacy has evolved rapidly over the last 50 years to keep pace with the rapid technological and knowledge advances that have characterized critical care medicine. The modern-day critical care pharmacist is a highly trained individual well suited for the interprofessional team-based care that critical illness necessitates. Critical care pharmacists improve patient-centered outcomes and reduce health care costs through three domains: direct patient care, indirect patient care, and professional service. Optimizing workload of critical care pharmacists, similar to the professions of medicine and nursing, is a key next step for using evidence-based medicine to improve patient-centered outcomes.
Topics: Humans; Pharmacists; Critical Care; Outcome Assessment, Health Care; Patient Care Team
PubMed: 37230553
DOI: 10.1016/j.ccc.2023.01.006 -
Air Medical Journal 2023Helicopter emergency medical services (HEMS) literature has been assessed in reviews focusing on various diagnoses, but there are few, if any, summaries of the entire... (Review)
Review
OBJECTIVE
Helicopter emergency medical services (HEMS) literature has been assessed in reviews focusing on various diagnoses, but there are few, if any, summaries of the entire body of HEMS outcomes evidence. Our goal was to summarize the existing research addressing patient-centered outcomes potentially accrued with HEMS.
METHODS
As part of the Critical Care Transport Collaborative Outcomes Research Effort, we generated the HEMS Outcomes Assessment Research Database and executed descriptive analyses of longitudinal trends from 1983 to 2022. Both indexed and gray literature sources were incorporated in the HEMS Outcomes Assessment Research Database. Studies were reviewed by at least 2 authors to select those that addressed a patient-centered outcome. Studies addressing solely HEMS logistics were excluded. Categoric analyses were executed with the Fisher exact test, and continuous variables were evaluated for normality with normal quantile plotting and a comparison of medians and 95% confidence intervals.
RESULTS
We found that HEMS outcomes study sample sizes increased steadily from 1983 to 2012, with the most recent decade demonstrating a marked increase in the rate of publication of HEMS outcomes studies. Most research (70.6%) addressed trauma patient outcomes, but recent decades have seen a significant increase in non-trauma studies. Recent decades have also been characterized by an increase in the production of HEMS outcomes research outside of North America and Europe.
CONCLUSION
This study summarizes the current state of the HEMS outcome literature. We highlight increasing contributions from worldwide researchers and increasing focus on HEMS benefits in non-trauma cases, particularly time-critical cases such as cardiac or stroke diagnoses. This provides a basis for further investigations into patient-oriented benefits potentially accrued with HEMS.
Topics: Humans; Air Ambulances; Aircraft; Emergency Medical Services; Europe; Outcome Assessment, Health Care; Retrospective Studies
PubMed: 37996177
DOI: 10.1016/j.amj.2023.07.003 -
Journal of Plastic, Reconstructive &... Nov 2023Surgical care today is no longer evaluated only on clinical outcomes but also on holistic patient wellbeing. Patient-reported outcomes (PROs) are a representation of the... (Review)
Review
Surgical care today is no longer evaluated only on clinical outcomes but also on holistic patient wellbeing. Patient-reported outcomes (PROs) are a representation of the patient's perspective on their results and wellbeing. The aim of this review is to establish PROs as the center of healthcare and plastic surgery, to delineate important PROs in plastic surgery practice and research, to discuss the future of PROs within our discipline, and to encourage surgeons to incorporate PROs into their practice. PROs are an important parallel of clinical outcomes in that they can use the patient's perspective to 1) support clinical findings, 2) detect differences in care when there are no clear clinical differences, 3) track progress longitudinally, and 4) support systemic improvements in healthcare. Plastic surgery as a field is naturally aligned with PROs because, as a discipline, we focus on patient form and function. The emerging forefronts of plastic surgery such as lymphedema care, gender-affirming care, peripheral nerve surgery, migraine surgery, and breast implant illness are critically dependent on PROs. In the next decade, we predict that there will be a continued proliferation of robust PRO measures and integration into healthcare delivery. Outcomes research in surgery should continue to evolve as surgeons provide increasingly more benefits to improve patient wellbeing. Plastic surgeons must continue to play a prominent role in the future of PROs.
Topics: Humans; Patient Reported Outcome Measures; Outcome Assessment, Health Care; Delivery of Health Care; Surgeons; Plastic Surgery Procedures
PubMed: 37688832
DOI: 10.1016/j.bjps.2023.08.008 -
Lupus Science & Medicine Feb 2024The paradigm of drug approval in SLE currently relies on successful large phase III randomised controlled trials and a set of primary, secondary and additional end... (Review)
Review
The paradigm of drug approval in SLE currently relies on successful large phase III randomised controlled trials and a set of primary, secondary and additional end points. Taken together, these outcomes offer a nuanced understanding of the efficacy and safety of the investigational agent. In this review, we thoroughly examine the main outcomes used in SLE trials and highlight unmet requirements as well as potential venues for future trial design in SLE. Disease activity indices can be broadly categorised into global-specific and organ-specific indices, in particular for skin, joints and kidneys, but there is no universal consensus about their use in clinical trials. Because each of these instruments has its own intrinsic strengths and weaknesses, the assessment of treatment response has progressed from relying solely on one individual disease activity index to using composite responder definitions. Those are typically measured from the trial baseline to the end point assessment date and may be combined with the need to taper and maintain glucocorticoids (GCs) within prespecified ranges. Remission and low disease activity are two critical states in the perspective of 'Treat-to-Target' trials, but are not fully recognised by regulators. While significant progress has been made in clinical trial outcomes for SLE, there is a clear need for continued innovation. Addressing these challenges will require collaboration between researchers, clinicians, patients as well as with regulatory agencies to refine existing outcome measures, incorporate meaningful and ethnically diverse patient perspectives, foster relevant digital opportunities and explore new therapeutic avenues, including early use of investigational agents. By doing so, we can advance our ability to manage SLE effectively and safely and improve the lives of those living with this complex and impactful autoimmune disease.
Topics: Humans; Treatment Outcome; Lupus Erythematosus, Systemic; Outcome Assessment, Health Care; Glucocorticoids
PubMed: 38360028
DOI: 10.1136/lupus-2023-001114 -
The British Journal of Dermatology Nov 2023Core outcome sets (COS) are consensus-driven sets of minimum outcomes that should be measured and reported in all clinical trials. COS aim to reduce heterogeneity in... (Review)
Review
BACKGROUND
Core outcome sets (COS) are consensus-driven sets of minimum outcomes that should be measured and reported in all clinical trials. COS aim to reduce heterogeneity in outcome measurement and reporting, and selective outcome reporting. Implementing COS into clinical trials is challenging. Guidance to improve COS uptake in dermatology is lacking.
OBJECTIVES
To develop a structured practical guide to COS implementation.
METHODS
Members of the Harmonising Outcome Measurement for Eczema (HOME) executive committee developed an expert opinion-based roadmap founded on a combination of a review of the COS implementation literature, the Core Outcome Measures in Effectiveness Trials (COMET) initiative resources, input from HOME members and experience in COS development and clinical trials.
RESULTS
The data review and input from HOME members was synthesized into themes, which guided roadmap development: (a) barriers and facilitators to COS uptake based on stakeholder awareness/engagement and COS features; and (b) key implementation science principles (assessment-driven, data-centred, priority-based and context-sensitive). The HOME implementation roadmap follows three stages. Firstly, the COS uptake scope and goals need to be defined. Secondly, during COS development, preparation for future implementation is supported by establishing the COS as a credible evidence-informed consensus by applying robust COS development methodology, engaging multiple stakeholders, fostering sustained and global engagement, emphasizing COS ease of use and universal applicability, and providing recommendations on COS use. Thirdly, incorporating completed COS into primary (trials) and secondary (reviews) research is an iterative process starting with mapping COS uptake and stakeholders' attitudes, followed by designing and carrying out targeted implementation projects. Main themes for implementation projects identified at HOME are stakeholder awareness/engagement; universal applicability for different populations; and improving ease-of-use by reducing administrative and study burden. Formal implementation frameworks can be used to identify implementation barriers/facilitators and to design implementation strategies. The effect of these strategies on uptake should be evaluated and implementation plans adjusted accordingly.
CONCLUSIONS
COS can improve the quality and applicability of research and, so, clinical practice but can only succeed if used and reported consistently. The HOME implementation roadmap is an extension of the original HOME roadmap for COS development and provides a pragmatic framework to develop COS implementation strategies.
Topics: Humans; Eczema; Outcome Assessment, Health Care; Consensus; Forecasting; Stakeholder Participation; Treatment Outcome; Research Design; Delphi Technique
PubMed: 37548315
DOI: 10.1093/bjd/ljad278