Clinical Care Research Articles

Perception of normal and treatment level ejaculatory latency times in men with premature ejaculation

Abstract Background Although the normal intravaginal ejaculation latency time (NIELT) as subjectively perceived by patients with premature ejaculation (PE) and expected IELT (EIELT), which represents the individual’s expectations of what treatment for PE would achieve, are critically influential in the treatment of patients with PE, there is a significant dearth of exploratory research on NIELT and EIELT among patients with PE. Aim To explore the NIELT and EIELT of patients with PE, understand why patients with PE perceive such a long IELT as normal, and identify factors associated with EIELT. Methods We recruited both patients with PE and control subjects, and analyzed the parameters related to IELT using detailed interviews and questionnaires. Outcomes Parameters related to IELT. Results A total of 592 individuals (mean age 29.6 ± 6.2) were included in the study, comprising 466 patients with PE (mean age 28.3 ± 5.4) and 126 non-PE individuals (mean age 34.6 ± 6.5). The actual perceived intravaginal ejaculation latency time (PIELT), referring to the patient’s self-assessed IELT at baseline, as well as NIELT, and EIELT of patients with PE, were 1.0 (1.0 − 2.0), 14.0 (10.0 − 15.0), and 15.0 (10.0 − 20.0), respectively. The control group’s PIELT and EIELT were 15.0 (10.0 − 20.0) and 20.0 (15.0 − 24.3), respectively, showing statistical differences compared with the PIELT and EIELT in the PE group. In the PE group and the control group, 31.5% and 57.9% of individuals, respectively, have an EIELT greater than the average actual normal ejaculatory latency time of 15.0 minutes. Among patients with PE, 51.3% expressed a NIELT >10 minutes, identical to the EIELT in a higher percentage (59.4%). The control group’s EIELT is 5 minutes longer than the PE group’s EIELT. Multivariable linear regression analysis showed that age, marital status, education level, BMI, satisfaction evaluation of PIELT, PEDT score, and IIEF-6 score were not associated with EIELT; only NIELT (beta = 0.817, P < 0.001) and PIELT (beta = 0.056, P = 0.044) were related to EIELT. Clinical implications Sexual health care providers should be aware that patients with PE have excessively high expectations for IELT. Strengths and limitation The first study explores why patients with clinically diagnosed PE perceive long IELT as normal and examines factors associated with EIELT. Further validation is needed in different cultural contexts. Conclusion Patients with PE often have excessively high expectations regarding IELT, primarily due to their insufficient understanding of IELT.

Moving beyond barriers: a mixed-method study to develop evidence-based strategies to improve implementation of PROMs in clinical oncology care

Moving beyond barriers: a mixed-method study to develop evidence-based strategies to improve implementation of PROMs in clinical oncology care

The Development of an Electronic Medical Record System to Improve Quality of Care for Individuals With Type 1 Diabetes in Rwanda: Qualitative Study

Background Electronic medical record (EMR) systems have the potential to improve the quality of care and clinical outcomes for individuals with chronic and complex diseases. However, studies on the development and use of EMR systems for type 1 (T1) diabetes management in sub-Saharan Africa are few. Objective The aim of this study is to analyze the need for improvements in the care processes that can be facilitated by an EMR system and to develop an EMR system for increasing quality of care and clinical outcomes for individuals with T1 diabetes in Rwanda. Methods A qualitative, cocreative, and multidisciplinary approach involving local stakeholders, guided by the framework for complex public health interventions, was applied. Participant observation and the patient’s personal experiences were used as case studies to understand the clinical care context. A focus group discussion and workshops were conducted to define the features and content of an EMR. The data were analyzed using thematic analysis. Results The identified themes related to feature requirements were (1) ease of use, (2) automatic report preparation, (3) clinical decision support tool, (4) data validity, (5) patient follow-up, (6) data protection, and (7) training. The identified themes related to content requirements were (1) treatment regimen, (2) mental health, and (3) socioeconomic and demographic conditions. A theory of change was developed based on the defined feature and content requirements to demonstrate how these requirements could strengthen the quality of care and improve clinical outcomes for people with T1 diabetes. Conclusions The EMR system, including its functionalities and content, can be developed through an inclusive and cocreative process, which improves the design phase of the EMR. The development process of the EMR system is replicable, but the solution needs to be customized to the local context.

External quality assessment-based tumor marker harmonization simulation; insights in achievable harmonization for CA 15-3 and CEA

Abstract Objectives CA 15-3 and CEA are tumor markers used in routine clinical care for breast cancer and colorectal cancer, among others. Current measurement procedures (MP) for these tumor markers are considered to be insufficiently harmonized. This study investigated the achievable harmonization for CA 15-3 and CEA by using an in silico simulation of external quality assessment (EQA) data from multiple EQA programs using patient-pool based samples. Methods CA 15-3 and CEA data from SKML (2021), UK NEQAS (2020–2021) and KEQAS (2020–2021) were used. A harmonization protocol was defined in which MPs that were considered equivalent were used to value assign EQA samples, and recalibration was only required if the MP had a bias of >5 % with value assigned EQA. Harmonization status was assessed by determining the mean level of agreement and residual variation by CV (%). Results Only MPs from Abbott, Beckman, Roche and Siemens were available in all EQA programs. For CA 15-3, recalibration was proposed for Beckman MP only and for CEA, recalibration was proposed for Siemens MP only. When the harmonization procedures were applied, for CA 15-3 the pre-harmonization mean bias range per MP was reduced from −29.28 to 9.86 %, into −0.09–0.12 % after harmonization. For CEA, the mean bias range per MP was reduced from −23.78 to 2.00 % pre-harmonization to −3.13–1.42 % post-harmonization. Conclusions The present study suggests that a significant improvement in the harmonization status of CA 15-3 and CEA may be achieved by recalibration of a limited number of MPs.

User-Centered Design and Usability of Voxe as a Pediatric Electronic Patient-Reported Outcome Measure Platform: Mixed Methods Evaluation Study

Background Electronic patient-reported outcome measures (ePROMs) are standardized digital instruments integrated into clinical care to collect subjective data regarding patients’ health-related quality of life, functional status, and symptoms. In documenting patient-reported progress, ePROMs can guide treatment decisions and encourage measurement-based care practices. Voxe is a pediatric and user-centered ePROM platform for patients with chronic health conditions. Objective We aimed to describe the user-centered design approach involving feedback from end users and usability testing of Voxe’s platform features to support implementation in a pediatric health care setting. Methods Purposive sampling was used to recruit patients aged 8-17 years from 2 chronic illness populations in 2 pediatric hospitals in Canada. Patients’ health care team members were also purposively recruited. One-on-one iterative testing sessions were conducted digitally by research team members with participants to obtain feedback on the appearance and functionalities of the Voxe platform prototype. Patients and health care providers (HCPs) completed Voxe-related task-based activities. International Organization for Standardization key performance indicators were tracked during HCP task-based activities. HCPs also completed the System Usability Scale. To test platform usability, the think-aloud technique was used by participants during the completion of structured tasks. After completing all task-based activities, patient participants selected 5 words from the Microsoft Desirability Toolkit to describe their overall impression and experience with the Voxe platform. Qualitative data about likes, dislikes, and ease of use were collected through semistructured interviews. Feedback testing sessions were conducted with patients and HCPs until Voxe was acceptable to participating end users, with no further refinements identified. Quantitative and qualitative data analysis were completed using descriptive statistics and content analysis. Results A total of 49 patients and 38 HCPs were recruited. Patients were positive about Voxe’s child-centered design characteristics and notification settings. HCPs rated Voxe as user-friendly and efficient, with the time to complete tasks decreasing over time. HCPs were satisfied with the Voxe platform functionalities and identified the value of Voxe’s system notifications, summarized display of ePROM results, and its capacity to integrate with electronic medical records. Patients’ and HCPs’ high satisfaction rates with the Voxe prototype highlight the importance of being responsive to user suggestions from the inception of eHealth platform developments to ensure their efficient and effective design. Conclusions This paper describes the user-centered creation and usability testing of Voxe as an ePROM platform for implementation into clinical care for pediatric patients with chronic health conditions. As a patient-facing platform that can be integrated into electronic medical records, Voxe aligns with measurement-based care practices to foster quality patient-centered approaches to care. End users’ positive feedback and evaluation of the platform’s user-friendliness and efficiency suggest that Voxe represents a valuable and promising solution to systematically integrate patient-related outcome (PRO) data into complex and dynamic clinical health care settings. International Registered Report Identifier (IRRID) RR2-10.1136/bmjopen-2021-053119

Definition and diagnosis of Parkinson’s disease: guideline “Parkinson’s disease” of the German Society of Neurology

Abstract Background Accurate definition and operational criteria for diagnosing Parkinson’s disease (PD) are crucial for evidence-based, patient-centered care. Objective To offer evidence-based recommendations for defining and diagnosing PD, incorporating contemporary clinical, imaging, biomarker, and genetic insights. Methods The guideline development began with the steering committee establishing key PICO (patient, intervention, comparison, outcome) questions, which were refined by the coauthors. Systematic literature searches identified relevant studies, reviews, and meta-analyses. Recommendations were drafted, evaluated, optimized, and voted upon by the German Parkinson’s Guideline Group. Results Parkinson’s disease (PD) is now understood to encompass a broader spectrum of etiologies than previously recognized. Advances in molecular pathogenesis, neuroimaging, and early clinical phenotypes suggest that PD is not a uniform disease entity and is often not idiopathic. This necessitates an updated framework for PD definition and diagnosis. The German Society for Neurology now endorses a broader concept of PD, incorporating both idiopathic and hereditary forms, as opposed to the previously narrower concept of “idiopathic Parkinson syndrome.” The revised guidelines recommend using the 2015 Movement Disorders Society diagnostic criteria, emphasize the importance of long-term clinical follow-up for improved diagnostic accuracy, and highlight the significance of non-motor symptoms in clinical diagnosis. Specific recommendations are provided for the use of imaging and fluid biomarkers and genetic testing to support the clinical diagnosis. Conclusion The updated guidelines from the German Society for Neurology enhance diagnostic accuracy for PD, promoting optimized clinical care.

Primary care practitioner and patient perspectives on care following bariatric surgery: A meta-synthesis of qualitative research.

Primary care is central to ongoing health care following bariatric surgery and patients indicate a preference for receiving follow-up support by their primary care practitioner (PCP). This meta-synthesis investigates the perspectives of both PCPs and patients in post-bariatric surgery care provided by PCPs. The aim was to synthesize themes from qualitative research to recommend improvements in post-bariatric surgery clinical care in primary care settings. Systematic searches of Scopus, Medline, EMBASE, PsycINFO, the Cochrane Library, and Google Scholar resulted in the inclusion of eight papers in the meta-synthesis. Papers were critiqued using the Critical Appraisal Skills Program (CASP) and thematically coded in Quirkos Cloud. Seven themes were reached by author consensus including stigma and judgment; clinician barriers and facilitators; patient-related support needs; communication considerations; patient context or determinants; health care setting; and adapting to life after surgery. PCPs reported barriers including poor communication and guidance from bariatric surgery centers, limited knowledge and training in bariatric patient care, and patients who may have unrealistic outcomes and poor health literacy. Patients seek comprehensive care from their PCP, however, barriers hindering the provision of this care include adverse surgical outcomes, a poor relationship with their PCP, and limited and short-term follow-up care from the PCP. Insights from this meta-synthesis offer actionable recommendations for PCPs and bariatric surgery centers to enhance patient care immediately.

What Is Culture Made of? An Exploratory Study of Ethical Cultures and Provider Perspectives on the Care of Periviable Neonates

Objective Studies examining intercenter variation in neonatal intensive care unit practices at the limits of fetal viability have hypothesized that institutional “culture” can be one of many factors that impact patient care. This study aimed to describe institutional culture at a single, large academic center with regard to the antenatal consultation, resuscitation, and postnatal management of periviable neonates. Study Design Members of six clinical groups—attending and fellow maternal–fetal medicine physicians, attending and fellow neonatal–perinatal medicine physicians, neonatal nurses, advanced practiced neonatal nurses, pediatric hospitalist physicians, and neonatal respiratory therapists—were invited to complete qualitative, semi-structured interviews. All audio recordings were transcribed. Dedoose software was used to complete team-based coding and thematic analysis. Results Twenty-two interviews were completed. Thematic analysis revealed three central themes described by participants as contributory to institutional culture: Perception, referring to factors based on individual attitudes and insights, Statements of Information, referring to factors anchored in more objective concepts such as outcomes data and institutional policy, and Dynamic Factors, referring to the relatively fluid factors of institutional culture that interact with both Perception and Statements of Information. Participants were more likely to mention factors in the Perception category (n = 430) compared with factors in the Information category (n = 225), and although the latter were described as critical components of antenatal counseling and perinatal management, the philosophy of our unit appeared to be more heavily rooted in institutional memory and individual belief systems. Conclusion Our data demonstrate a personal undertone to institutional culture at the limits of viability, with an emphasis on individual attitudes and subjective interpretations of fact rather than empirical data. As the landscape of neonatology continues to change, understanding those factors that contribute to culture remains a necessary step toward deconstructing institutional belief systems and optimizing clinical care. Key Points

Strength of Evidence Underlying the CMS-FDA Parallel Review of Comprehensive Genomic Profiling Tests in the Cancer Setting.

Although use of comprehensive genomic profiling (CGP) was approved by a novel CMS/FDA parallel review process, the quality of the supporting evidence is unclear. We evaluated the rigor of the peer-reviewed literature cited in the National Coverage Determination Memorandum for the FoundationOne CDx (F1CDx). We identified studies cited in the memorandum. Two independent researchers evaluated each study and applied a modified version of the Fryback and Thornbury hierarchy[1], an established framework for evaluating the efficacy of diagnostic tests. Studies focused on clinical outcomes were then categorized by study design, guided by recommendations from the Center for Medical Technology Policy. The sample included 113 scientific studies. The majority (n = 60, 53.1%) used CGP outside the course of clinical care, and there was significant heterogeneity in the cancer types assessed and sequencing depth. We found 8 (7.1%) studies that assessed whether clinical care had changed due to CGP testing, and 38 (33.6%) assessed clinical outcomes. After excluding studies that tested for five or fewer genomic alterations, 25 remained in the clinical outcomes sample: Of these, only one included a comparator group that did not receive CGP testing. Only four studies used F1CDx as the primary genomic test, none of which compared the outcomes of patients who did vs did not receive the F1CDx test. The findings indicate gaps in the supporting evidence for broad CGP use in patients with solid tumors. More rigorous studies that assess clinical utility would better inform the approval process for novel diagnostic tests.

Discharge Follow-Up of Patients in Primary Care Does Not Meet Their Care Needs: Results of a Longitudinal Multicentre Study

Adequate coordination between healthcare levels has been proven to improve clinical indicators, care costs, and user satisfaction. This is more relevant to complex or vulnerable patients, who often require increased care. This study aims to evaluate the differences between hospital discharge follow-up indicators, including number of general practitioners’ (GPs) and community nurses’ (CNs) consultations, presentiality of consultations, type of first post-discharge consultation, and time between hospital discharge and first consultation. Vulnerable and non-vulnerable patients were compared. A longitudinal retrospective study was carried out in the north of Tenerife on the post-discharge care of patients discharged from the Canary Islands University Hospital (Spanish acronym HUC) between 1 January 2018 and 31 December 2022. The results obtained show deficiencies in the care provided to patients by primary care (PC) after being discharged from the hospital, including delayed first visits, low presentiality of those visits that were less frequent even with increased patient complexity, scarce first home visits to functionally impaired patients and delays in such visits, and a lack of priority visits to patients with increased follow-up needs. Addressing these deficiencies could help those most in need of care to receive PC, thus reducing inequalities and granting equal access to healthcare services in Spain.

Identifying Facilitators and Barriers to Implementation of AI-Assisted Clinical Decision Support in an Electronic Health Record System.

Recent advancements in computing have led to the development of artificial intelligence (AI) enabled healthcare technologies. AI-assisted clinical decision support (CDS) integrated into electronic health records (EHR) was demonstrated to have a significant potential to improve clinical care. With the rapid proliferation of AI-assisted CDS, came the realization that a lack of careful consideration of socio-technical issues surrounding the implementation and maintenance of these tools can result in unanticipated consequences, missed opportunities, and suboptimal uptake of these potentially useful technologies. The 48-h Discharge Prediction Tool (48DPT) is a new AI-assisted EHR CDS to facilitate discharge planning. This study aimed to methodologically assess the implementation of 48DPT and identify the barriers and facilitators of adoption and maintenance using the validated implementation science frameworks. The major dimensions of RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) and the constructs of the Consolidated Framework for Implementation Research (CFIR) frameworks have been used to analyze interviews of 24 key stakeholders using 48DPT. The systematic assessment of the 48DPT implementation allowed us to describe facilitators and barriers to implementation such as lack of awareness, lack of accuracy and trust, limited accessibility, and transparency. Based on our evaluation, the factors that are crucial for the successful implementation of AI-assisted EHR CDS were identified. Future implementation efforts of AI-assisted EHR CDS should engage the key clinical stakeholders in the AI tool development from the very inception of the project, support transparency and explainability of the AI models, provide ongoing education and onboarding of the clinical users, and obtain continuous input from clinical staff on the CDS performance.

Evaluating video and hybrid group consultations in general practice: mixed-methods, participatory study protocol (TOGETHER 2)

Background General practice is facing an unprecedented challenge in managing the consequences of the pandemic. In the midst of a policy drive to balance remote and in-person service provision, substantial workload pressures remain, together with increasing prevalence of long-term conditions, and declining staff numbers and morale. To address these challenges, some practices in the UK have been delivering video and hybrid group consultations (VHGCs) providing clinical care to multiple patients at the same time. Despite positive initial findings and enthusiasm, there are still gaps in our understanding of the influence VHGCs have on patient experience, healthcare utilisation, quality, safety, equity and affordability. Objectives To generate an in-depth understanding of VHGCs for chronic conditions in general practice, surface assumptions and sociotechnical dynamics, inform practice and extend theorisation. Methods Mixed-methods, multi-site research study using co-design and participatory methods, from qualitative, quantitative and cost-related perspectives. WP1 includes a national, cross-sectional survey on VHGC provision across the UK. In WP2 we will engage patients and general practice staff in co-design workshops to develop VHGC models with emphasis on digital inclusion and equity. In WP3 we will carry out a mixed-methods process evaluation in up to 10 GP practices across England (5 sites already running VHGCs and 5 comparison sites). Qualitative methods will include interviews, focus groups and ethnographic observation to examine the experiences of patients, carers, clinical and non-clinical NHS staff, commissioners and policy-makers. Quantitative methods will examine the impact of VHGCs on healthcare utilisation in primary and secondary care, patient satisfaction, engagement and activation. We will also assess value for money of group and individual care models from a health economics perspective. Conclusions We aim to develop transferable learning on sociotechnical change in healthcare delivery, using VHGCs as an exemplar of technology-supported innovation. Findings will also inform the design of a future study.

Patients carrying pathogenic SCN8A variants with loss‐ and gain‐of‐function effects can be classified into five subgroups exhibiting varying developmental and epileptic components of encephalopathy

AbstractObjectivePhenotypic heterogeneity presents challenges in providing clinical care to patients with pathogenic SCN8A variants, which underly a wide disease spectrum ranging from neurodevelopmental delays without seizures to a continuum of mild to severe developmental and epileptic encephalopathies (DEEs). An important unanswered question is whether there are clinically important subgroups within this wide spectrum. Using both supervised and unsupervised machine learning (ML) approaches, we previously found statistical support for two and three subgroups associated with loss‐ and gain‐ of‐ function vari‐ants, respectively. Here, we test the hypothesis that the unsupervised subgroups (U1–U3) are distinguished by differential contributions of developmental and epileptic components.MethodsWe predicted that patients in the U1 and U2 subgroups would differ in timing of developmental delay and seizure onset, with earlier and concurrent onset of both features for the U3 subgroup. Standard statistical procedures were used to test these predictions, as well as to investigate clinically relevant associations among all five subgroups.ResultsTwo‐population proportion and Kruskal–Wallis tests supported the hypothesis of a reversed order of developmental delay and seizure onset for patients in U1 and U2, and nearly synchronous developmental delay/seizure onset for the U3 (termed DEE) subgroup. Association testing identified subgroup variation in treatment response, frequency of initial seizure type, and comorbidities, as well as different median ages of developmental delay onset for all five subgroups.SignificanceUnsupervised ML approaches discern differential developmental and epileptic components among patients with SCN8A‐related epilepsy. Patients in U1 (termed developmental encephalopathy) typically gain seizure control yet rarely experience improvements in development, whereas those in U2 (termed epileptic encephalopathy) have fewer if any developmental impairments despite difficulty in achieving seizure control. This understanding improves prognosis and clinical management and provides a framework to discover mechanisms underlying variability in clinical outcome of patients with SCN8A‐related disorders.

Artificial Intelligence in the U.S. Military Health System: Forging a New Frontier for Clinical Care and Efficiency

ABSTRACT The Military Health System (MHS) has historically been at the forefront of innovation in medicine and science, but it has also historically struggled to implement battlefield innovations or civilian technologies for wider domestic use. Artificial intelligence (AI) has emerged as a transformative force in health care with civilian health systems and institutions at the forefront of these innovations. While these tools have the potential to support resolution of military health’s most pressing issues, the MHS is behind its civilian counterparts in advancing AI. Adoption of AI could benefit the MHS in such areas as service member and beneficiary access to care; more precise allocation of medical personnel and resources; improved operations of military treatment facilities; early detection of emerging threats to health; and force multiplication of existing telehealth capabilities. This evolving and highly visible technology also presents challenges in the military context above those in the civilian context, such as additional levels of privacy and security, integration with purpose-built secure systems, and additional regulatory obligations. To address these, the MHS should engage in three lines of effort to advance AI: establishing governance, education and training of medical personnel, and engaging in research, development, testing, and piloting of AI applications. This will require dedicated personnel and resources for a substantial initial outlay to be recouped later through more effective administration and care. By leveraging lessons learned from civilian systems, the MHS can design, adopt, and implement AI solutions to improve care for service members in both domestic and operational contexts, and for their beneficiaries.

Reproductive options and genetic testing for patients with an inherited cardiac disease.

In the past decade, genetic testing for cardiac disease has become part of routine clinical care. A genetic diagnosis provides the possibility to clarify risk for relatives. For family planning, a genetic diagnosis provides reproductive options, including prenatal diagnosis and preimplantation genetic testing, that can prevent an affected parent from having a child with the genetic predisposition. Owing to the complex genetic architecture of cardiac diseases, characterized by incomplete disease penetrance and the interplay between monogenic and polygenic variants, the risk reduction that can be achieved using reproductive genetic testing varies among individuals. Globally, disparities, including regulatory and financial barriers, in access to reproductive genetic tests exist. Although reproductive options are gaining a prominent position in the management of patients with inherited cardiac diseases, specific policies and guidance are lacking. Guidelines recommend that prenatal diagnosis and preimplantation genetic testing are options that should be discussed with families. Health-care professionals should, therefore, be aware of the possibilities and feel confident to discuss the benefits and challenges. In this Review, we provide an overview of the reproductive options in the context of inherited cardiac diseases, covering the genetic, technical, psychosocial and equity considerations, to prepare health-care professionals for discussions with their patients.

Alterations in circulating immunoregulatory proteins discriminate poor CD4 T lymphocyte trajectories in people with HIV on suppressive antiretroviral therapy.

It is essential to track immune perturbations related to insufficient CD4 T-cell recovery in PWH on suppressive ART as those with incomplete reconstitution are at a greater risk of non-AIDS-related morbidity and mortality. Several inflammatory soluble mediators have associated with poor immune reconstitution and adverse morbid outcomes in PWH, yet their implementation into routine clinical care to guide management remains inconsistent. Circulating immune checkpoint proteins have been linked to dysregulated immune pathways during suppressive ART and may serve as improved surrogate markers of clinical relevance. Here we investigate soluble lymphocyte-associated immunoregulatory proteins in virally suppressed PWH with no reported co-morbid outcomes and varying CD4 T-cell counts, to reveal underlying pathways that remain perturbed despite ART. This novel signature of immunoregulatory markers pertaining to poor CD4 T-cell trajectories uncover previously overlooked immune checkpoints as important targets for clinical monitoring of PWH in the setting of durable viral suppression by ART.

Considerations for the design and conduct of pediatric obesity pharmacotherapy clinical trials: Proceedings of expert roundtable meetings.

Anti-obesity medications (AOMs) have emerged as one element of comprehensive obesity clinical care intended to improve long-term health outcomes for children and adolescents. The number of pediatric AOM clinical trials has burgeoned in recent years as new pharmacotherapeutics have been developed. Factors related to growth and development in children and adolescents can present unique challenges in terms of designing and conducting clinical trials investigating the safety and efficacy of AOMs. These barriers can delay the AOM development and evaluation process, increase the cost of performing trials, create challenges in the interpretation of results, influence the generalizability of the findings and present ethical dilemmas. In an effort to address these issues and provide guidance to streamline the process of designing and conducting pediatric AOM clinical trials, relevant key stakeholders convened a series of roundtable meetings to discuss, debate and achieve harmonization on design features. Stakeholder participants included a multidisciplinary group of international pediatric obesity experts, patient (parent) representatives and representatives from academic medicine, key regulatory agencies and industry. Topics of discussion included primary efficacy end-points, secondary end-points, eligibility criteria, trial run-in and follow-up phases, use of active comparators and guidelines for down-titration and/or stopping rules for excessive weight reduction. Consensus recommendations were agreed upon. Regarding end-points, emphasis was placed on moving away from BMI z-score as a primary outcome, incorporating multiple alternative BMI-related outcomes and measuring adiposity/body fat as a prominent secondary end-point. Trial eligibility criteria were carefully considered to maximize generalizability while maintaining safety. The limited value of trial run-in phases was discussed. It was also underscored that designing trials with extended follow-up periods after AOM withdrawal should be avoided owing to ethical issues (including possible psychological harm) related to weight regain without providing the opportunity to access other treatments. The panel emphasized the value of the randomized, placebo-controlled trial but recommended the thoughtful consideration of the use of active comparators in addition to, or instead of, placebo to achieve clinical equipoise when appropriate. Finally, the panel recommended that clinical trial protocols should include clear guidance regarding AOM down-titration to avoid excessive weight reduction when applicable.

The relationship between Parkinson's disease and sexual hyperactivity secondary to drug treatment: A systematic review.

This review addresses the prevalence of hypersexual behavior in Parkinson's patients and the underlying neurobiological mechanisms, identifying risk and protective factors, comparing incidence among different treatments, and proposing recommendations for management and prevention. To conduct a review on the relationship between Parkinson's disease and hypersexual behavior as a result of pharmacological treatment. The search strategy, guided by PRISMA and PICOS criteria, focuses on the correlation between Parkinson's disease and hypersexual behavior due to pharmacological treatment. Utilizing databases like PubMed and Proquest, studies from the last 10 years in English or Spanish were selected, emphasizing clinical trials with Parkinson's patients under treatment. Inaccessible, irrelevant, or mixed-sample studies were excluded. The Cochrane Scale assessed the risk of bias. Out of 122 records, 103 remained after eliminating duplicates; 48 were reviewed, and ultimately, 6 studies met the inclusion criteria for analysis. Synthesizing the risk and protective factors linked to hypersexual behavior in Parkinson's patients receiving pharmacological treatment underscores the critical need for early detection and incorporation of these factors into clinical care. The suggested guidelines for managing and preventing hypersexual behavior in these patients carry substantial practical implications.

Building Frontline Capability for Shared Decision-Making (SDM) in a Major Academic Oncology Center Caring for People With Non-Small Cell Lung Cancer: Performance Outcomes of a SDM Simulation Training Program.

There is a growing body of evidence on shared decision-making (SDM) training programs worldwide. However, there is wide variation in program design, duration, effectiveness, and evaluation in both academia (ie, medical school) and the practice setting. SDM training has been slow to integrate in practice settings. A pilot study of 6 multidisciplinary clinicians was conducted using quantitative and qualitative methods to evaluate changes in participant understanding and implementation of SDM in the practice setting. A 2-rater criterion-based evaluation method was used to assess a simulation-based case study role-play program using 7 domains of SDM pre and post training. The authors assessed whether clinicians addressed each of the 7 domains or what fraction of each domain was addressed as part of their simulation case study role-play performance. Focus groups were conducted pre- and postintervention to provide feedback to participants and to understand the clinician experience in greater detail. The increase in improvement in SDM ranged from 17% to 37%, and 7 of 8 domains for which participants were rated showed significant improvement. The areas of greatest improvement were seen in determining a patient's goals/preferences, including risk tolerance regarding treatments (+37%) and values and self-efficacy (+37%). The results of this study reveal a significant shift in clinician awareness of a patient's goals, preferences, and values. Postintervention, clinicians began to understand the value of building a partnership with their patients whereby the patient becomes an active participant in their clinical care.

Stevens-Johnson syndrome and toxic epidermal necrolysis-like eruptions in patients treated with immune checkpoint inhibitors: a systematic review.

Immune checkpoint inhibitors (ICIs) have transformed cancer treatment by targeting immune checkpoints such as PD-1, PDL-1, and CTLA-4, but concerns about severe immune-related adverse events persist. The scarcity of literature on dermatologic implications, especially severe reactions such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), highlights the urgent need for investigation. Our systematic review aims to address the gap in relevant literature by extensively examining the epidemiologic risk factors and management of SJS/TEN-like illnesses in ICI-treated patients to provide insights for risk assessment and clinical care. We identified 158 case reports that detailed the incidence of SJS/TEN in patients being treated with ICIs, examining demographic patterns, type of malignancy, clinical characteristics, and treatments linked to onset. We assessed mortality rates, risk elements, and the effectiveness of interventions to help guide clinical care. Analysis of 158 case reports revealed that SJS/TEN in ICI users is typically seen on average at the age of 63 and is more common in males. PD1 inhibitors such as nivolumab and pembrolizumab are often associated with various mucocutaneous patterns and significant risks with ICI use, especially TEN, which is linked to high morbidity and mortality rates. Our study notes limitations due to the inclusion of case reports or case series, such as potential publication and reporting biases, leading to skewed findings. Additionally, because of the heterogeneous reporting standards, the retrospective nature limits phenotypic precision, control for confounding variables, and data completeness. Our study provides valuable insights into the epidemiology, clinical features, management strategies, and outcomes of ICI-induced SJS/TEN, underscoring the importance of vigilant monitoring and personalized risk assessment in oncology practice. Continued research efforts are essential to optimize patient outcomes and enhance the safety profile of ICIs in cancer therapy.