Journal of evaluation in clinical practice最新文献

{"title":"Signal Detection at SFDA: A Comprehensive Analysis of Current Practices and Future Directions","authors":"Mohammed I. Fouda,&nbsp;Abdulaziz Alakeel,&nbsp;Roaa M. Alamri,&nbsp;Mobarak S. Al Shahrani,&nbsp;Ali Y. Al Shahrani","doi":"10.1111/jep.70062","DOIUrl":"https://doi.org/10.1111/jep.70062","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>The Saudi Food and Drug Authority (SFDA) plays a pivotal role in safeguarding public health through robust pharmacovigilance. Since establishing its signal detection section in 2015, SFDA has implemented a comprehensive framework to monitor and evaluate drug safety through proactive data collection, advanced analytical methods, and international collaborations.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>To provide a comprehensive analysis of the current practices in signal detection at SFDA, assess the effectiveness of its regulatory framework, in-house priority system, active surveillance programme, and global collaborations, and to offer recommendations for future enhancements in pharmacovigilance.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>A scientific review was conducted using publicly available literature, official SFDA guidelines, and internal reports. The evaluation focused on the regulatory mandate, data collection methodologies, signal generation processes (including weekly scanning of diverse sources), case validation, and the integration of advanced statistical techniques. Special emphasis was given to the in-house priority algorithm, active surveillance initiatives, and collaborative efforts with international bodies.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>The review highlights that SFDA's robust regulatory framework and innovative in-house priority algorithm have enhanced the efficiency of signal detection. The active surveillance programme has significantly increased the capacity for real-time monitoring, while global collaborations have facilitated knowledge exchange and harmonised methodologies. However, challenges persist regarding data quality, resource allocation, and the need for continuous training and improved communication among stakeholders.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>SFDA's signal detection system effectively contributes to drug safety in Saudi Arabia by combining rigorous regulatory practices with innovative analytical methods and international cooperation. Addressing current challenges through advanced technologies, enhanced resource allocation, and strengthened stakeholder communication is recommended to further improve pharmacovigilance practices and ensure public health protection.</p>\u0000 </section>\u0000 </div>","PeriodicalId":15997,"journal":{"name":"Journal of evaluation in clinical practice","volume":"31 3","pages":""},"PeriodicalIF":2.1,"publicationDate":"2025-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143818772","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Paradigmatic Shift: Telehealth Counselling's Expansion and Challenges in India","authors":"Anganabha Baruah","doi":"10.1111/jep.70089","DOIUrl":"https://doi.org/10.1111/jep.70089","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>This study provides a comprehensive analysis of the rapid expansion and transformative impact of telehealth counselling in India, a trend significantly propelled by the challenges posed by the COVID-19 pandemic.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methodology</h3>\u0000 \u0000 <p>This paper presents a perspective on the current telehealth landscape, synthesizing insights from an extensive literature review. The investigation integrates qualitative insights from health care practitioners and clients, allowing for a multifaceted understanding of the emerging obstacles linked to telehealth implementation. The synthesis is structured around several key concepts identified in the literature, including the efficacy of telehealth counselling services compared to traditional face-to-face interactions, the resilience of mental health services during crises, and the growing acceptance of digital modalities among patients. Additionally, it explores significant challenges such as disparities in technological access, the need for comprehensive regulatory frameworks, varying levels of patient receptivity, infrastructural limitations, and the readiness of health care professionals to adopt telehealth technologies.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>By focusing on these areas, the paper elucidates the complex interplay of technical, regulatory, and cultural factors shaping the telehealth ecosystem in India. It advocates for urgent policy enhancements and the continuous integration of technology to effectively address these barriers.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Discussion</h3>\u0000 \u0000 <p>This perspective underscores the potential for telehealth counselling to evolve into a permanent and essential component of India's mental health service delivery model, ultimately contributing to a more resilient and accessible health care system.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>The conclusions drawn emphasize the necessity for targeted policy interventions and the establishment of robust technological infrastructures to foster a more inclusive and effective telehealth environment, ensuring mental health services reach all segments of the population.</p>\u0000 </section>\u0000 </div>","PeriodicalId":15997,"journal":{"name":"Journal of evaluation in clinical practice","volume":"31 3","pages":""},"PeriodicalIF":2.1,"publicationDate":"2025-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143818656","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Reasons for Downgrading the Certainty of Evidence for Indirectness in Synthesis of Surgical Procedures for Patients With Fractures: A Meta-Research Analysis","authors":"Julia Pozzetti Daou,&nbsp;Rachel Riera,&nbsp;Rafael Leite Pacheco","doi":"10.1111/jep.70091","DOIUrl":"https://doi.org/10.1111/jep.70091","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Rationale</h3>\u0000 \u0000 <p>Indirectness occurs when the synthesized evidence may not be directly applied to the relevant clinical context. A common argument used by surgeons is that evidence that arises from clinical trials is limited due to a lack of fidelity regarding surgery techniques, materials, and surgeon and center experience. Considering that there are many particularities in surgical interventions for the treatment of bone fractures, diverseness is expected among trials that randomized patients to compare surgical procedures. An in-depth analysis of how this expected diverseness is reflected in indirectness judgments on the certainty of synthesized evidence is lacking.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Aims and Objectives</h3>\u0000 \u0000 <p>To analyze the certainty of evidence from all Cochrane reviews of surgical interventions for the treatment of patients with bone fractures and the reasons for indirectness downgrading.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Method</h3>\u0000 \u0000 <p>A meta-research analysis of all Cochrane systematic reviews that compare any surgical interventions in patients with any type of bone fracture. A sensitive search was conducted in the Cochrane Database of Systematic Review from inception to 16 October 2024.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>The certainty of the evidence of all Cochrane reviews of surgical interventions for patients with fractures is very low or low in 66.5% of eligible outcomes. Indirectness contributed to the certainty downgrade in only 12.26% of outcomes (26/212), and of those, the indirectness was related to the intervention in 11.5% (4/26). The results show that although the certainty of evidence of surgical interventions for patients with fractures is usually downgraded, indirectness is not a common cause of concern.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>The certainty of evidence for surgical interventions in patients with fractures is typically downgraded, often to very low. However, indirectness is not a common reason for such downgrading. The anticipated diverseness regarding surgery techniques, materials, and surgeon and center experience was not impactful in the overall certainty of evidence in the Cochrane reviews that were included.</p>\u0000 </section>\u0000 </div>","PeriodicalId":15997,"journal":{"name":"Journal of evaluation in clinical practice","volume":"31 3","pages":""},"PeriodicalIF":2.1,"publicationDate":"2025-04-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/jep.70091","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143786693","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Causes of Burn Injury in Children for Preschool","authors":"Mohammad Qtait","doi":"10.1111/jep.70054","DOIUrl":"https://doi.org/10.1111/jep.70054","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>Burn injuries are prevalent worldwide, especially in developing countries; and there are significant children burn injuries in Palestine. This study was performed to analyse the pattern, cause, of burn injuries in Palestine.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Prospective study, we undertook a prospective study of all patients under 6 years who admitted to burn unit 1 January 2022, and 31 December 2022. In-person interviews with the children's parents determined the burns' genesis and environmental causes. Demographic and clinical data were obtained.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Result</h3>\u0000 \u0000 <p>The population being studied had a mean age of 3.1 years. The majority of the 91 patients who were burned did so because of scalds. Flame 10 sufferers represented 60% of the patients; 60% were residents of urban areas. Five people were living in residence. Most of the children (81 of the total) were with another person at the time of the burn injury, and the kitchen was the location of the burn in 41 cases.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>The patients' crowded environment was a challenge. Even when an adult was close, the caretaker did not watch the child well. Burns are likely in the kitchen, where people cook and eat harmful foods. First, ensure the kitchen is safe, and then apply other safety procedures around the house to decrease the danger of burns to children.</p>\u0000 </section>\u0000 </div>","PeriodicalId":15997,"journal":{"name":"Journal of evaluation in clinical practice","volume":"31 3","pages":""},"PeriodicalIF":2.1,"publicationDate":"2025-04-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143786703","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Exploring the Prevalence and Predictors of Persistently High Primary Care Use Among National Health Insurance Patients in a Nigerian Medical Facility","authors":"Godpower Chinedu Michael,&nbsp;Zainab Abdulazeez Umar,&nbsp;Bukar Alhaji Grema","doi":"10.1111/jep.70081","DOIUrl":"https://doi.org/10.1111/jep.70081","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Rationale</h3>\u0000 \u0000 <p>A small group of healthcare users make frequent hospital visits (≥ 10 annually) and consume a disproportionate amount of healthcare resources. Their characteristics among insured patients in developing countries like Nigeria are poorly understood.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Objectives</h3>\u0000 \u0000 <p>To assess the prevalence and predictors of persistently high primary care (PHPC) use (≥ 10 visits in two consecutive years) among National Health Insurance Authority (NHIA) enrollees.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>This retrospective cross-sectional study analyzed data from 380 randomly selected patients at the NHIA Clinic of a Nigerian tertiary hospital in 2022. Using a standardized proforma, their 2018 and 2019 data were collected, including biodata, clinic visit characteristics, diagnoses, and costs of medicines and investigations.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>The sample population was predominantly females (62.6%) with a mean age of 37.5 years. In 2018/2019, 75% (285/380) of patients visited for infectious diseases and 37.6% (143/380) for cardiovascular diseases (CVD). Only 2.6% (10/380) were PHPC users. The median cost of care was higher among PHPC users than the remaining users in 2018 (₦30,549.00 [US$84.60] vs. ₦10,290.00 [US$28.50]; Mann Whitney test [MWT] = 16.73, <i>p</i> &lt; 0.001) and in 2019 (₦41,238.50[US$114.20] vs. ₦9,523.50 [US$26.40]; MWT = 18.81, <i>p</i> &lt; 0.001). Older age, tribe, and having CVD were significantly associated with PHPC use, with CVD being a strong predictor (OR = 11.38, <i>p</i> = 0.037).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>The prevalence of PHPC users was low, yet they consumed 3 to 4 times more resources in medicines and investigations than the other remaining patients. Patients with CVDs could form targets for interventions to reduce unnecessary visits and lower cost of care.</p>\u0000 </section>\u0000 </div>","PeriodicalId":15997,"journal":{"name":"Journal of evaluation in clinical practice","volume":"31 3","pages":""},"PeriodicalIF":2.1,"publicationDate":"2025-04-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143786705","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"General Practitioners' Perceptions of Patient Involvement—An Interview Study","authors":"Birgitte Nørgaard,&nbsp;Elisa Simonsen,&nbsp;Nanna Aarup Skotte,&nbsp;Michael Marcussen","doi":"10.1111/jep.70077","DOIUrl":"https://doi.org/10.1111/jep.70077","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Rationale and Aim</h3>\u0000 \u0000 <p>General practitioners (GPs) play an increasingly important role in the healthcare system, wherein patient involvement is a key element in delivering individualized and tailored treatment. This study aimed to explore GPs' perceptions of user involvement and their considered challenges and opportunities regarding user involvement.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>A qualitative study with semi-structured interviews was conducted. The approach was inductive and open, and data were analysed thematically. Twelve GPs were recruited through snowball sampling and individually interviewed in March–April 2021.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Six themes were generated: Relation and knowledge; Negotiation; Compliance; Information, communication and dialog; Time and process; and GPs' considerations of involvement. The GPs described a plethora of tools and strategies to shape their relationship with the patient, individually inform the patient, and negotiate their power to achieve compliance and, thus, the best treatment for the patient.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>GPs consider patient involvement equal to information as a means to compliance to some extent, but they also consider information and compliance interdependent. However, patient involvement is challenging for the GPs when the patient is misinformed or when the GP's current status is poor.</p>\u0000 </section>\u0000 </div>","PeriodicalId":15997,"journal":{"name":"Journal of evaluation in clinical practice","volume":"31 3","pages":""},"PeriodicalIF":2.1,"publicationDate":"2025-04-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/jep.70077","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143786704","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Machine Learning and Deep Learning in Detection of Neonatal Seizures: A Systematic Review","authors":"Rüya Naz,&nbsp;Özlem Örsal","doi":"10.1111/jep.70083","DOIUrl":"https://doi.org/10.1111/jep.70083","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Neonatal seizures are one of the most prevalent clinical manifestations of neurological conditions, requiring urgent intervention and detection. Machine learning (ML) and Deep Learning (DL) is an emerging promising tool for detecting and managing such conditions.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Purpose</h3>\u0000 \u0000 <p>This study aimed to investigate the effect of ML and DL on the detection of neonatal seizures.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>In April 2024, previous studies in English were searched in PubMed, ScienceDirect, Cochrane Library, Google Scholar, and Scopus using the search terms “Neonatal,” “seizure,” “machine learning,” and “detection.” A total of 3512 studies were reviewed due to a non-blinded screening by 2 authors. The scoping review included ten previous studies that met the inclusion criteria.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>In this study, the time series of electroencephalogram signals during 1389 seizures with an average of 834 h of a minimum of 17 and a maximum of 258 newborns admitted to the neonatal intensive care unit were reviewed using ML approaches for the mean area under the receiver operating characteristic curve (AUC) in 7 studies, sensitivity and specificity in 4 studies, and both AUC and sensitivity and specificity in 1 study. The AUC for detecting neonatal seizures ranged from 80.7 to 99.3, and sensitivity and specificity ranged between 60.4 and 93.38 on average.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>Models derived from convolutional neural networks have high power to detect neonatal seizures early and distinguish patients with and without true seizures. Thus, it is suggested that further ML and DL models for neonatal seizures should be developed, the number of experimental studies should be increased, and the intensive care units should be integrated.</p>\u0000 </section>\u0000 </div>","PeriodicalId":15997,"journal":{"name":"Journal of evaluation in clinical practice","volume":"31 3","pages":""},"PeriodicalIF":2.1,"publicationDate":"2025-04-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143787306","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Using Real-World Evidence for Clinical Development to Address the Gap Between Marketing Authorisation and Reimbursement in European Countries: Insights From Literature Review","authors":"Antoine Pugeat,&nbsp;Ramon Hernandez,&nbsp;Walid Shouman,&nbsp;Divya Pushkarna,&nbsp;Jean-Paul Collet,&nbsp;Paulo Carita","doi":"10.1111/jep.70090","DOIUrl":"https://doi.org/10.1111/jep.70090","url":null,"abstract":"&lt;div&gt;\u0000 \u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Background&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;Health Technology Assessment (HTA) agencies require evidence relevant to elements like the ‘added value’ of the drug, efficacy and safety in real life, or data regarding the drugs' effects on different subgroups of interest. Using Real-World Evidence (RWE) during drug clinical development can provide the information required for HTA approval.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Objective&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;Two targeted literature reviews (TLRs) were conducted to narratively describe the reasons for the gap between EMA market authorisation and market access in France and Germany; the possible importance of RWE studies to provide relevant clinical evidence for HTA approval and, therefore, their role to support drug clinical development programmes in Europe.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Methods&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;Relevant studies were identified by searching Embase using predefined search strategy via the Ovid platform. Additional studies were included from external keyword searches on Google Scholar and PubMed that address the objective of the review. Further searches were conducted in the Haute Autorité de Santé (HAS) and the Gemeinsamer Bundesausschuss (GBA) websites to identify examples of reimbursement submissions.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Results&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;The average time to access drugs was 128 days in Germany and 508 days in France. Delays in patient access to new drugs resulted in diminished patient benefits. The delays in the approval of new drugs were attributed to several clinical factors, including: (i) lack of safety and efficacy data from the submitted clinical trial; (ii) absence of clinically relevant comparators; (iii) lack of demonstration of added value and (iv) inability to contextualise data to the local population. RWE can be valuable in supporting clinical evidence generation by providing a complementary set of information to address gaps in knowledge regarding the drug's effectiveness and safety. It can also offer an external arm for comparison when randomisation is not feasible. Furthermore, RWE can support the demonstration of a drug's added benefit over existing therapies and help define its role in disease management. However, RWE studies also face several limitations, including variability in data quality, challenges in addressing specific research questions, methodological constraints and concerns about the credibility of analyses.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Conclusion&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;Access to medication is usually delayed due to the HTA agency's requirements for scientifically robust clinical evidence about th","PeriodicalId":15997,"journal":{"name":"Journal of evaluation in clinical practice","volume":"31 3","pages":""},"PeriodicalIF":2.1,"publicationDate":"2025-04-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143787307","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"‘SWell’ Staff Wellbeing Interventions in Paediatric Critical Care: A Feasibility Study","authors":"Rachel L. Shaw,&nbsp;Amy Fox,&nbsp;Shoshana Gander-Zaucker,&nbsp;Karen Maher,&nbsp;Sally Crighton","doi":"10.1111/jep.70092","DOIUrl":"https://doi.org/10.1111/jep.70092","url":null,"abstract":"&lt;div&gt;\u0000 \u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Introduction&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;Paediatric Critical Care (PCC) staff experience high levels of stress, distress and burnout. The objective was to test feasibility of delivering staff wellbeing interventions in UK PCC units.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Materials and Methods&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;The method was a feasibility study of Staff Wellbeing interventions using standardized psychological measures.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Study Design and Participants&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;We conducted a multi-centre feasibility (non-randomised) study at 14 UK PCC units during 2023. Interdisciplinary PCC staff were recruited through principal investigators (PIs) at each site.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Data Collection Instruments&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;The primary outcome measure tested was the Short Warwick Edinburgh Mental Well-Being Scale. Secondary outcome measures tested were: Brief Resilience Scale, Hospital Anxiety and Depression Scale with acceptability and feasibility surveys. All were completed online using Qualtrics.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Procedures&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;Two ‘SWell’ Staff Wellbeing interventions were tested: Mad-Sad-Glad and Wellbeing Images with Appreciative Inquiry. They were low-intensity, group-based, structured reflective discussions delivered by PIs. Baseline measures (&lt;i&gt;t&lt;/i&gt;0) were completed by 596 staff, 264 (43%) completed immediate post-intervention (&lt;i&gt;t&lt;/i&gt;1), with 6% and 5% at 3 (&lt;i&gt;t&lt;/i&gt;2) and 6 (&lt;i&gt;t&lt;/i&gt;3) months post-intervention, respectively.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Results&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;50% (&lt;i&gt;n&lt;/i&gt; = 14) of UK PCC units delivered 104 interventions to 573 staff demonstrating delivery feasibility.&lt;/p&gt;\u0000 \u0000 &lt;p&gt;Wilcoxon signed-rank tests found that wellbeing scores and depression scores were significantly improved in matched pairs (&lt;i&gt;t&lt;/i&gt;0, &lt;i&gt;t&lt;/i&gt;1; &lt;i&gt;n&lt;/i&gt; = 130). Staff ratings indicated high acceptability and feasibility for incorporating interventions into everyday practice.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Discussion&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;‘SWell’ interventions are feasible to deliver. Pre/post data collection is possible but significant attrition prohibited long-term follow-up. Significant improvements in wellbeing demonstrated appropriateness of outcome measures to detect changes in psychological wellbeing. Further evaluat","PeriodicalId":15997,"journal":{"name":"Journal of evaluation in clinical practice","volume":"31 3","pages":""},"PeriodicalIF":2.1,"publicationDate":"2025-04-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/jep.70092","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143786695","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Fractal Geometry and the Complexity of Medical Decision-Making","authors":"Benjamin Doolittle,&nbsp;Andrew Loza","doi":"10.1111/jep.70086","DOIUrl":"https://doi.org/10.1111/jep.70086","url":null,"abstract":"<div>\u0000 \u0000 <p>With advances in technology, medical decision-making has become increasingly complex. Fractal geometry provides a framework to grapple with this daunting complexity. Fractals are defined as, ‘infinitely complex patterns that are self-similar across different scales.’ These patterns have been used to understand the seeming randomness of recurring patterns in nature, financial markets, quantum physics, and even forest fires, war, and the respiratory system. Mandlebrot the mathematician who discovered his eponymous fractal pattern wrote, ‘Beautiful, damn hard, increasingly useful. That's fractals.’ The same could be said about medicine. To understand optimal medical decision making, we need to examine not only performance, but the complexity-cost to obtain that performance. This complexity can be visualized through the fractal tree of potential branches produced by a plan of care. To confront the growing complexity of medical care, we must prune this fractal tree while ensuring favorable outcomes. To do this, we offer three propositions as pruning shears for the complexity of the fractal tree: wisdom, trust, and prevention.</p>\u0000 </div>","PeriodicalId":15997,"journal":{"name":"Journal of evaluation in clinical practice","volume":"31 3","pages":""},"PeriodicalIF":2.1,"publicationDate":"2025-04-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143770252","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}