Healthcare Research Research Articles

Development of a core outcome set for breast cancer-related lymphedema: a Delphi study.

For breast cancer survivors (BCS) living with breast cancer-related lymphedema (BCRL), what outcome domains (OD) should be measured to assess the burden of the disease and efficacy of interventions? A Core Outcome Set (COS) that promotes standardized measurement of outcomes within the constraints of time influenced by work environments is essential for patients and the multidisciplinary professionals that manage and research BCRL. Using Delphi methodology, a multidisciplinary group of BCRL experts (physical and occupational therapists, physicians, researchers, physical therapist assistants, nurses, and massage therapist) completed two waves of online surveys. BCRL expert respondents that completed the first survey (n = 78) had an average of 26.5years in practice, whereas, respondents who completed the second survey (n = 33) had an average of 24.9years. ODs were included in the COS when consensus thresholds, ranging from 70% to 80%, were met. A total of 12 ODs made up the COS. Reaching a minimum consensus of 70%; volume, tissue consistency, pain, patient-reported upper quadrant function, patient-reported health-related quality of life, and upper extremity activity and motor control were recommended at different phases of the BCRL continuum in a time-constrained environment. Joint function, flexibility, strength, sensation, mobility and balance, and fatigue met an 80% consensus to be added when time and resources were not constrained. The COS developed in this study thoroughly captures the burden of BCRL. Using this COS may reduce selective reporting, inconsistency in clinical use, and variability of reporting across interdisciplinary healthcare fields, which manage or research BCRL.

Multimodal risk prediction with physiological signals, medical images and clinical notes

The broad adoption of electronic health record (EHR) systems brings us a tremendous amount of clinical data and thus provides opportunities to conduct data-based healthcare research to solve various clinical problems in the medical domain. Machine learning and deep learning methods are widely used in the medical informatics and healthcare domain due to their power to mine insights from raw data. When adapting deep learning models for EHR data, it is essential to consider its heterogeneous nature: EHR contains patient records from various sources including medical tests (e.g. blood test, microbiology test), medical imaging, diagnosis, medications, procedures, clinical notes, etc. Those modalities together provide a holistic view of patient health status and complement each other. Therefore, combining data from multiple modalities that are intrinsically different is challenging but intuitively promising in deep learning for EHR. To assess the expectations of multimodal data, we introduce a comprehensive fusion framework designed to integrate temporal variables, medical images, and clinical notes in EHR for enhanced performance in clinical risk prediction. Early, joint, and late fusion strategies are employed to combine data from various modalities effectively. We test the model with three predictive tasks: in-hospital mortality, long length of stay, and 30-day readmission. Experimental results show that multimodal models outperform uni-modal models in the tasks involved. Additionally, by training models with different input modality combinations, we calculate the Shapley value for each modality to quantify their contribution to multimodal performance. It is shown that temporal variables tend to be more helpful than CXR images and clinical notes in the three explored predictive tasks.

Healthcare Capacity Building in Northwest Syria: Challenges, Successes, and Lessons Learned

The conflict in Syria has caused significant loss of life and widespread displacement. Northwest Syria (NWS) has been heavily impacted, leading to challenges in providing healthcare services. Attacks on healthcare workers and facilities have worsened the situation. Healthcare students and professionals have been specifically targeted, disrupting their education and resulting in migration and a shortage of skilled healthcare workers. To address these challenges, local and international organizations and institutions have supported long-term projects to improve healthcare facilities and provide a trained healthcare workforce. Collaborations with multiple stakeholders have been established to ensure comprehensive and effective training opportunities, enabling healthcare workers to better serve the population's healthcare needs. A range of undergraduate, postgraduate, and research programs have been developed to enhance healthcare capacity building. These programs aim to strengthen the knowledge and skills of healthcare professionals in NWS. Efforts have been made to strengthen the health system and build the capacity of policy makers in utilizing evidence-based knowledge for informed policy decisions. Global and regional partnerships, along with adequate funding, have played a significant role in the successful enhancement of capacity building activities at all levels.
 Building healthcare and health research capacity in underdeveloped and conflict-affected parts of NWS presents numerous challenges. Underdeveloped infrastructure, inadequate teaching and service delivery tools, gender disparities, and the sustainability of funding create obstacles to effective capacity building. The political context, coupled with security concerns further complicate efforts. The accreditation of education, and the brain drain of skilled healthcare professionals, add to the difficulties in strengthening the healthcare system in NWS. Addressing these challenges requires comprehensive and collaborative approaches that prioritize stability, security, gender equity, sustainable funding, and improved coordination and resources for education and service delivery. The lessons learned from capacity-building efforts in the Syrian conflict have broader implications for other regions facing similar challenges.

Training healthcare professionals to administer Goal Attainment Scaling as an outcome measure

BackgroundGoals generated by Goal Attainment Scaling (GAS) can be used as an outcome measure to promote person-centred research and care. There are no training packages which support its use outside of the rehabilitation discipline. This paper describes the development and evaluation of a training package to support the implementation of GAS as an outcome measure in healthcare research. The training package consisted of classroom teaching, a training manual for self-directed learning, one-on-one simulation and hot reviews. It was developed for the GOAL Trial, a randomised controlled trial assessing a Comprehensive Geriatric Assessment’s effectiveness in enabling frail older people living with chronic kidney disease to attain their goals. Training participants were invited to complete pre- and post-training online evaluation surveys.ResultsForty-two healthcare professionals attended an initial online classroom teaching, with 27 proceeding to administer GAS to GOAL Trial patients. Response rates for the online pre- and post-training surveys were 95% and 72%, respectively. Prior to training, only 15% of participants reported being able to appropriately scale and troubleshoot GAS goals. Post-training this was 92%. There was 100% participant satisfaction for the training manual, one-on-one simulation, and hot reviews.ConclusionsThis training package helps ensure healthcare professionals administering GAS have adequate knowledge and skills. It has the potential for adoption as a guide to support the implementation of GAS by other researchers seeking to embrace persont-centred principles in their work.

Viral DNAemia and DNA Virus Seropositivity and Mortality in Pediatric Sepsis

Sepsis is a leading cause of pediatric mortality. Little attention has been paid to the association between viral DNA and mortality in children and adolescents with sepsis. To assess the association of the presence of viral DNA with sepsis-related mortality in a large multicenter study. This cohort study compares pediatric patients with and without plasma cytomegalovirus (CMV), Epstein-Barr virus (EBV), herpes simplex virus 1 (HSV-1), human herpesvirus 6 (HHV-6), parvovirus B19 (B19V), BK polyomavirus (BKPyV), human adenovirus (HAdV), and torque teno virus (TTV) DNAemia detected by quantitative real-time polymerase chain reaction or plasma IgG antibodies to CMV, EBV, HSV-1, or HHV-6. A total of 401 patients younger than 18 years with severe sepsis were enrolled from 9 pediatric intensive care units (PICUs) in the Eunice Kennedy Shriver National Institute of Child Health and Human Development Collaborative Pediatric Critical Care Research Network. Data were collected from 2015 to 2018. Samples were assayed from 2019 to 2022. Data were analyzed from 2022 to 2023. Death while in the PICU. Among the 401 patients included in the analysis, the median age was 6 (IQR, 1-12) years, and 222 (55.4%) were male. One hundred fifty-four patients (38.4%) were previously healthy, 108 (26.9%) were immunocompromised, and 225 (56.1%) had documented infection(s) at enrollment. Forty-four patients (11.0%) died in the PICU. Viral DNAemia with at least 1 virus (excluding TTV) was detected in 191 patients (47.6%) overall, 63 of 108 patients (58.3%) who were immunocompromised, and 128 of 293 (43.7%) who were not immunocompromised at sepsis onset. After adjustment for age, Pediatric Risk of Mortality score, previously healthy status, and immunocompromised status at sepsis onset, CMV (adjusted odds ratio [AOR], 3.01 [95% CI, 1.36-6.45]; P = .007), HAdV (AOR, 3.50 [95% CI, 1.46-8.09]; P = .006), BKPyV (AOR. 3.02 [95% CI, 1.17-7.34]; P = .02), and HHV-6 (AOR, 2.62 [95% CI, 1.31-5.20]; P = .007) DNAemia were each associated with increased mortality. Two or more viruses were detected in 78 patients (19.5%), with mortality among 12 of 32 (37.5%) who were immunocompromised and 9 of 46 (19.6%) who were not immunocompromised at sepsis onset. Herpesvirus seropositivity was common (HSV-1, 82 of 246 [33.3%]; CMV, 107 of 254 [42.1%]; EBV, 152 of 251 [60.6%]; HHV-6, 253 if 257 [98.4%]). After additional adjustment for receipt of blood products in the PICU, EBV seropositivity was associated with increased mortality (AOR, 6.10 [95% CI, 1.00-118.61]; P = .049). The findings of this cohort study suggest that DNAemia for CMV, HAdV, BKPyV, and HHV-6 and EBV seropositivity were independently associated with increased sepsis mortality. Further investigation of the underlying biology of these viral DNA infections in children with sepsis is warranted to determine whether they only reflect mortality risk or contribute to mortality.

Obesity and risk of depressive disorder in children and adolescents: A meta-analysis of observational studies.

This meta-analysis evaluated the relationship between overweight/obesity and depressive disorders in children and adolescents. We examined the databases of PubMed, Embase and Web of Science for pertinent observational studies released up until 20 February 2022. The pooled relative risks (RRs) and 95% confidence intervals (CIs) of obesity and overweight with depressive disorder were calculated by means of random-effects models. The Newcastle-Ottawa Quality Assessment Scale and Agency for Healthcare Research and Quality scale were adopted to evaluate the study quality. Finally, for this meta-analysis, we evaluated 22 observational publications covering 175 135 participants (5 cohort study articles, 1 case-control study article and 16 cross-sectional study articles). A significant positive association was found between obesity and the risk of depression (RR 1.32, 95% CI 1.09-1.60, I2 = 79.90%, Pheterogeneity < 0.001) and in the association between obesity and depressive symptoms (RR 1.16, 95% CI: 1.00-1.35, I2 = 25.0%, Pheterogeneity = 0.247). On sensitivity analysis, the pooled RRs remained robust. Subgroup analysis indicated that obese children and teenagers in western countries were more prone to depression. Evidence from this meta-analysis, based on observational studies, supported the idea that obese children and adolescents are more likely to experience depression and depressive symptoms.

Co-production of health and social science research with vulnerable children and young people: A rapid review.

The term 'care-experienced' refers to anyone who is currently in care or has been in care at any stage in their life. A complex interplay of factors leads to care-experienced children and young people (CECYP) experiencing poorer oral health and access to dental care than their peers. A rapid review of the co-production of health and social care research with vulnerable children and young people (CYP) was carried out to inform the development of a co-produced research project exploring the oral health behaviours and access to dental services of CECYP. Here, 'co-production' refers to the involvement of CYP in the planning or conduct of research with explicit roles in which they generate ideas, evidence and research outputs. To learn how to meaningfully involve vulnerable CYP in the co-production of health and social science research. To identify: Different approaches to facilitating the engagement of vulnerable CYP in co-production of health and social science research; different activities carried out in such approaches, challenges to engaging vulnerable CYP in co-production of health and social science research and ways to overcome them and areas of best practice in relation to research co-production with vulnerable CYP. A rapid review of peer-reviewed articles was conducted in six databases (MEDLINE, Embase, SocINDEX, CINAHL, PsycINFO and Web of Science) and grey literature to identify studies that engaged vulnerable CYP in co-approaches to health and social research. Of 1394 documents identified in the search, 40 were included and analysed. A number of different approaches to co-production were used in the studies. The CYP was involved in a range of activities, chiefly the development of data collection tools, data collection and dissemination. Individual challenges for CYP and researchers, practical and institutional factors and ethical considerations impacted the success of co-production. Co-production of health and social science with vulnerable CYP presents challenges to researchers and CYP calling for all to demonstrate reflexivity and awareness of biases, strengths and limitations. Used appropriately and well, co-production offers benefits to researchers and CYP and can contribute to research that reflects the needs of vulnerable CYP. Adherence to the key principles of inclusion, safeguarding, respect and well-being facilitates this approach. Members of our patient and public involvement and stakeholder groups contributed to the interpretation of the review findings. This manuscript was written together with a young care leaver, Skye Boswell, who is one of the authors. She contributed to the preparation of the manuscript, reviewing the findings and their interpretation.

Impact of Early Nutrition Interventions on the Growth and Development of Preterm Infants: A Narrative Review.

Preterm birth remains a significant global health concernas it can lead to various health complications and long-term developmental challenges. Early nutrition intervention plays a crucial role in optimizing the growth, development, and overall health outcomes of premature infants. This review aims to summarize and analyze the existing literature regarding the effect of early nutrition interventions on premature babies. A comprehensive search was conducted through various electronic databases, including PubMed, Scopus, and Google Scholar, focusing on nutrition interventions specifically targeting premature infants. The review highlights the benefits of early nutrition interventions, including enteral and parenteral feeding, human milk, and the provision of specific nutrients. These interventions have been shown to enhance growth rates, promote neurodevelopmental outcomes, reduce the incidence and severity of retinopathy of prematurity (ROP), reduce the risk of infection, and improve overall morbidity and mortality rates in premature babies. Overall, the findings from this review suggest that early nutrition interventions have a positive impact on the health and developmental outcomes of premature babies. However, further research is required to determine the optimal approaches, optimal timing, and long-term effects of various interventions. Collaboration between healthcare providers, researchers, and families is crucial in implementing evidence-based nutrition practices and supporting the growth and development of premature infants.

Global Guidelines in Dermatology Mapping Project (GUIDEMAP)-A systematic review of the methodological quality of contact dermatitis clinical practice guidelines.

The Global Guidelines in Dermatology Mapping Project (GUIDEMAP) assesses the methodological quality of clinical practice guidelines (CPGs) for high-burden skin diseases. This review focuses on contact dermatitis. We searched MEDLINE, Embase, PubMed, Web of Science, Cochrane Library, Emcare, Epistemonikos, PsycINFO and Academic Search Premier for CPGs published between 1 November 2018 and 1 November 2023. Prespecified guideline resources were hand searched. Two authors independently undertook screening, data extraction and quality assessments. Instruments used were the Appraisal of Guidelines for Research and Evaluation (AGREE) II Reporting Checklist, the U.S. Institute of Medicine's (IOM) criteria of trustworthiness, The Agency for Healthcare Research and Quality's National Guideline Clearinghouse Extent Adherence to Trustworthy Standards (NEATS) Instrument and Lenzer's Red Flags. Twenty five CPGs were included, exhibiting heterogeneity in both the topics they addressed and their methodological quality. Whereas the CPGs on management of hand eczema from Denmark, Europe and the Netherlands scored best, most CPGs fell short of being clear, unbiased, trustworthy and evidence-based. Disclosure of conflicts of interest scored well, and areas needing improvement include 'strength and wording of recommendations', 'applicability', 'updating' and 'external review'. Adhering to AGREE II and Grading of Recommendations, Assessment, Development and Evaluations (GRADE) enhances methodological quality.

New perspectives on advances in diagnosis through imaging in chronic respiratory diseases: a systematic literature review

Background: Chronic respiratory diseases, such as asthma, chronic obstructive pulmonary disease (COPD), interstitial lung disease, and cystic fibrosis, present substantial global health challenges. This systematic review explores recent advances in imaging-based diagnostic methods for these conditions, emphasizing high-resolution computed tomography (HRCT), magnetic resonance imaging (MRI), positron emission tomography (PET), and artificial intelligence (AI). Methodology: A systematic search of databases identified studies published in the last five years, focusing on innovative imaging techniques for chronic respiratory diseases. Inclusion criteria emphasized diagnostic accuracy and advancements in imaging modalities. Results: Seven studies were included, covering interventions in intensive care, mesenchymal stem cell therapy for COVID-19-induced acute respiratory distress syndrome (ARDS), endovascular treatment for aortic arch aneurysms, and lung cancer screening. MSC therapy demonstrated positive outcomes in ARDS patients, while endovascular repair showed technical success. LungSEARCH highlighted the effectiveness of lung cancer screening in high-risk populations. Discussion: Recent imaging technologies, including HRCT, MRI, PET, and AI, have revolutionized chronic respiratory disease diagnosis. The review emphasizes their clinical applications, impact on patient outcomes, and potential for personalized medicine. AI enhances image analysis accuracy, yet challenges like cost and interpretation discrepancies persist. Conclusion: Imaging technologies, particularly HRCT, MRI, PET, and AI, show promise in improving diagnostic accuracy and personalized treatment for chronic respiratory diseases. Collaboration among healthcare professionals, researchers, and industry stakeholders is crucial for addressing challenges and ensuring widespread access to advanced diagnostic tools. Future directions involve refining imaging methods for routine clinical integration, advancing patient care, and reducing the burden of respiratory diseases.

Estimates of 30-day postoperative pulmonary complications after gastrointestinal endoscopic procedures: A retrospective cohort analysis of a health system population.

The incidence of 30-day postoperative pulmonary complications (PPC) of gastrointestinal endoscopic procedures (GIEP) are not well characterized in the literature. The primary aim of this study was to identify the incidence of 30-day PPC after GIEP within a large healthcare system. We conducted a retrospective cohort study of 5377 patients presenting for GIEP between January 2013 and January 2022. Our primary outcome was the Agency for Healthcare Research and Quality PPC composite (AHRQ-PPC). Secondary outcomes were sub-composites derived from the AHRQ-PPC; including pneumonia (AHRQ-PNA), respiratory failure (AHRQ-RF), aspiration pneumonia/ pneumonitis (AHRQ-ASP) and pulmonary emboli (AHRQ-PE). We performed propensity score matching (PSM) followed by multivariable logistic regression to analyze primary and secondary outcomes. Inpatients had higher 30-day AHRQ-PPC (6.0 vs. 1.2%, p<0.001), as well as sub-composite AHRQ-PNA (3.2 vs. 0.7%, p<0.001), AHRQ-RF (2.4 vs. 0.5%, p<0.001), and AHRQ-ASP (1.9 vs. 0.4%, p<0.001). After PSM adjustment, pre-procedural comorbidities of electrolyte disorder [57.9 vs. 31.1%, ORadj: 2.26, 95%CI (1.48, 3.45), p<0.001], alcohol abuse disorder [16.7 vs. 6.8%, ORadj: 2.66 95%CI (1.29, 5.49), p = 0.01], congestive heart failure (CHF) [22.3 vs. 8.7%, ORadj: 2.2 95%CI (1.17, 4.15), p = 0.02] and pulmonary circulatory disorders [21 vs. 16.9%, ORadj: 2.95, 95%CI (1.36, 6.39), p = 0.01] were associated with 30-day AHRQ-PPC. After covariate adjustment, AHRQ-PPC was associated with upper endoscopy more than lower endoscopy [5.9 vs. 1.0%, ORadj: 3.76, 95%CI (1.85, 7.66), p<0.001]. When compared to gastroenterologist-guided conscious sedation, anesthesia care team presence was protective against AHRQ-PPC [3.7 vs. 8.4%, ORadj: 0.032, 95%CI (0.01, 0.22), p<0.001] and AHRQ-ASP [1.0 vs. 3.37%, ORadj: 0.002, 95%CI (0.00, 0.55), p<0.001]. In conclusion, we report estimates of 30-day PPC after GIEP across inpatient and outpatient settings. Upper endoscopic procedures confer a higher risk, while the presence of an anesthesia care team may be protective against 30-day PPC.

Evaluation of accuracy and potential harm of ChatGPT in medical nutrition therapy - a case-based approach

Background ChatGPT is a conversational large language model (LLM) based on artificial intelligence (AI). LLMs may be applied in health care education, research, and practice if relevant valid concerns are proactively addressed. The current study aimed to investigate ChatGPT’s ability to generate accurate and comprehensive responses to nutritional queries created by nutritionists/dieticians. Methods An in-depth case study approach was used to accomplish the research objectives. Functional testing was performed, creating test cases based on the functional requirement of the software application. ChatGPT responses were evaluated and analyzed using various scenarios requiring medical nutritional therapy, which were created with varied complexity. Based on the accuracy of the generated data, which were evaluated by a registered nutritionist, a potential harm score for the responses from Chat GPT was used as evaluation. Results Eight case scenarios with varied complexity when evaluated revealed that, as the complexity of the scenario increased, it led to an increase in the risk potential. Although the accuracy of the generated response does not change much with the complexity of the case scenarios, the study suggests that ChatGPT should be avoided for generating responses for complex medical nutritional conditions or scenarios. Conclusions The need for an initiative that engages all stakeholders involved in healthcare education, research, and practice is urgently needed to set up guidelines for the responsible use of ChatGPT by healthcare educators, researchers, and practitioners. The findings of the study are useful for healthcare professionals and health technology regulators.

Measuring patient activation: the utility of the Patient Activation Measure administered in an interview setting

BackgroundPatient activation is an emerging field in healthcare research concerning knowledge, skills, and confidence of patients in managing their health. This is particularly important for patients with chronic diseases, who often require more complex care management and self-care skills. However, due to temporary or longer-lasting visual impairments, certain patient groups cannot answer a questionnaire independently. The main objective is to investigate the psychometric properties of the German Patient Activation Measure® (PAM) survey in an everyday clinical setting where it has to be read aloud.MethodsOutpatients with macular edema participated in this questionnaire-based cross-sectional study. The study assessed patient activation by the PAM® survey, self-rated health, self-efficacy, quality of life, and general mood. Interviewers read questionnaires aloud to patients. Psychometric properties of the PAM® survey were investigated by item response theory (IRT), Cronbach’s α and trait–trait correlations.ResultsThe analysis included N = 554 patients. Median age was 69 (IQR 62.0–76.0) years and mean overall activation score 74.1 (SD 13.7). All items showed ceiling effects. Empirical reliability from the IRT model and Cronbach’s α were 0.75. The PAM® survey showed a Spearman correlation of 0.54 with self-efficacy, 0.51 with quality of life and 0.34 with general mood.ConclusionThe read-aloud PAM® survey has been shown to provide to adequate measurement precision and convergent validity to be used as a screening tool in an everyday clinical setting. Objective assessment in an interview setting with the PAM® survey is possible. PAM® items are good in distinguishing lower to middle activated patients, but not patients with high activation. Further, issues with structural validity need more investigation.

Nursing Interventions to Empower Family Caregivers to Manage the Risk of Falling in Older Adults: A Scoping Review.

Falls pose a significant risk to older adults, resulting in injuries and declining quality of life. The psychological impact, particularly the fear of falling, impairs their well-being. This pervasive fear affects daily activities, leading to self-imposed limitations and reduced engagement. This review aimed to identify nursing interventions to empower family caregivers to manage the risk of falling in older adults. A scoping review was developed following the JBI framework. We searched the CINAHL, MEDLINE, Nursing & Allied Health Collection, Cochrane Central Register of Controlled Trials, MedicLatina, and Cochrane Database of Systematic Reviews. The findings of this review revealed that out of 460 initially identified records, nine articles met the eligibility criteria and were retained for further in-depth analysis. These articles provided insights into nine distinct categories of nurse interventions: Therapeutic Relationships, Family Involvement, Personalized Care, Health Education, Multifactorial Falls Risk Assessment, Home Modifications, Referral, Transition Between Healthcare Services, and Health Care Consultants. The findings of this review have significant implications for clinical practice, particularly in emphasizing the crucial role of nurses in empowering family caregivers and older adults to manage the risk of falling at home. Healthcare professionals, policymakers, and researchers can benefit from this informative resource to develop strategies and guidelines.

Legacy lessons from the COVID-19 era to improve trial participation and retention: Views from trial participants, PPIE contributors and trial staff across the NIHR portfolio.

The Covid-19 pandemic had a profound effect on the delivery of healthcare research. Covid-19 research was prioritised and many non-essential trials were paused. This study explores the engagement experiences of trial participants', PPIE contributors' and trial staff during the Covid-19 pandemic and towards recovery and restoring a diverse and balanced UK clinical trials portfolio. Interviews and focus groups were undertaken with PPIE contributors, trial participants and trial staff members from NIHR research trials across the UK (November 2020-June 2021) across portfolio specialities: Cancer, Oral and Dental Health, Musculoskeletal Disorders, Cardiovascular Disease, Neurological Disorders, Primary Care, and Conditions associated with susceptibility to Covid-19 (Diabetes, Stroke, Respiratory Disorders). Topic guides were developed for each participant group and interviews were conducted over Zoom. The transcripts were analysed using codebook thematic analysis in NVivo (V.12). 106 participants comprising, 45 PPIE contributors, 27 trial participants and 34 trial staff members were recruited. Three themes to engagement with trials during Covid-19 were developed. 1) Ensuring continued contact. Continued and tailored communication, having a trial point of contact and regular updates all enhanced trial engagement and retention. Patients' unfamiliarity with materials being sent electronically reduced engagement and trust. 2) A balanced move to remote consultations. Remote follow-up and monitoring were convenient and allowed for wider recruitment across the UK. Participants were more likely to discuss personal subjects in their own homes. Remote visits lacked a personal touch, some concerns over missed diagnoses or being unable to appreciate the situation, technical abilities or equipment failures were seen as barriers, especially for disadvantaged or older people. 3) The importance of feeling fully informed. Factors that supported attendance were knowledge about trial conduct adherence to Covid-19 regulations, social distancing, clear signage at the site and opportunities to ask questions. Barriers included not knowing what to expect and not feeling safe with rules and regulations. Our findings highlight a number of ways to future proof trial delivery against future pandemics or disruptions such as offering online options to participate in research, ensuring consistent communication between participants and the research team, making sure participants feel fully informed and the continued reassurance of safety in the clinical setting.

Commentary] Applying the Rule of Designers and Architects “Form Follows Function (FFF)” Can Reduce Misinterpretations and Methodical Shortcomings in Healthcare

Sir Archibald Cochrane requested about 100 years ago answers to three questions before implementation of innovations in health care. These answers request the confirmation of efficacy, i.e. the “Proof of Principle (PoP)”, of the objective “Real-World Effectiveness (RWE)” and of the subjectively perceived value (VAL) of health care services. At the same time Sir Ronald A. Fisher developed the concept of the Randomized Controlled Trial (RCT) for research in agriculture. This concept has become the accepted gold standard for demonstration of effects in health care research in the past 50 years. RCTs are a useful study design to answer the first of the three Cochrane questions “Can it work?”. A wide range of different tools is available to answer the third (subjective) Cochrane question “Is it worth it?”, but none of these tools can answer the second question “Does it work?” in an unselected sample of patients of day-to-day care who present a variety of different comorbidities. We need to consider that the patient individual baseline risk profile may have a stronger effect on the assessed outcomes than our interventions. Without knowledge of the individual patient risk profile, we may probably disregard the strongest effect on the assessed outcomes. Our comment substantiates and justifies the need of a new method than the RCT for demonstration of RWE. For that, we propose the Pragmatic Controlled Trial (PCT) and describe 1) the methods we used for analysis of data and the emerging strategy recommended for the three-dimensional assessment of outcomes, 2) the identification of the terminology conflict, 3) example to illustrate the evaluation using a PCT, 4) limitations of a PCT, 5) potential impact of the PCT, 6) literature on similar studies. In summary, The PCT enables the answer to the second Cochrane question. This answer is based on the important effects of the “Endpoint-Specific Risk Profiles (ESRPs) of individual patients on the explored endpoints. In addition, the PCT facilitates the standardized analysis of revenue and expenses. The time and costs of documentation for approval of drugs and medical devices can be effectively reduced due to considerable reduction of necessary experimental RCTs for demonstration of PoP. The results of PCTs also enable new justifications of ethical, medical, economic, and political decisions.

Layered vulnerability and researchers’ responsibilities: learning from research involving Kenyan adolescents living with perinatal HIV infection

BackgroundCarefully planned research is critical to developing policies and interventions that counter physical, psychological and social challenges faced by young people living with HIV/AIDS, without increasing burdens. Such studies, however, must navigate a ‘vulnerability paradox’, since including potentially vulnerable groups also risks unintentionally worsening their situation. Through embedded social science research, linked to a cohort study involving Adolescents Living with HIV/AIDS (ALH) in Kenya, we develop an account of researchers’ responsibilities towards young people, incorporating concepts of vulnerability, resilience, and agency as ‘interacting layers’.MethodsUsing a qualitative, iterative approach across three linked data collection phases including interviews, group discussions, observations and a participatory workshop, we explored stakeholders’ perspectives on vulnerability and resilience of young people living with HIV/AIDS, in relation to home and community, school, health care and health research participation. A total of 62 policy, provider, research, and community-based stakeholders were involved, including 27 ALH participating in a longitudinal cohort study. Data analysis drew on a Framework Analysis approach; ethical analysis adapts Luna’s layered account of vulnerability.ResultsALH experienced forms of vulnerability and resilience in their daily lives in which socioeconomic context, institutional policies, organisational systems and interpersonal relations were key, interrelated influences. Anticipated and experienced forms of stigma and discrimination in schools, health clinics and communities were linked to actions undermining ART adherence, worsening physical and mental health, and poor educational outcomes, indicating cascading forms of vulnerability, resulting in worsened vulnerabilities. Positive inputs within and across sectors could build resilience, improve outcomes, and support positive research experiences.ConclusionsThe most serious forms of vulnerability faced by ALH in the cohort study were related to structural, inter-sectoral influences, unrelated to study participation and underscored by constraints to their agency. Vulnerabilities, including cascading forms, were potentially responsive to policy-based and interpersonal actions. Stakeholder engagement supported cohort design and implementation, building privacy, stakeholder understanding, interpersonal relations and ancillary care policies. Structural forms of vulnerability underscore researchers’ responsibilities to work within multi-sectoral partnerships to plan and implement studies involving ALH, share findings in a timely way and contribute to policies addressing known causes of vulnerabilities.

Envisioning the Future of ChatGPT in Healthcare: Insights and Recommendations from a Systematic Identification of Influential Research and a Call for Papers

Background and Aims: ChatGPT represents the most popular and widely used generative artificial intelligence (AI) model that received significant attention in healthcare research. The aim of the current study was to assess the future trajectory of the needed research in this domain based on the recommendations of the top influential published records.&#x0D; Materials and Methods: A systematic search was conducted on Scopus, Web of Science, and Google Scholar (27–30 November 2023) to identify the top ten ChatGPT-related published records in healthcare across the three databases. Classification of the records as “top” denoting high influence in the field was based on citation counts.&#x0D; Results: A total of 22 unique records from 17 different journals representing 14 different publishers were identified as the top ChatGPT-related publications in healthcare subject. Based on the identified records’ recommendations, the following themes appeared as important areas to consider in future ChatGPT research in healthcare: improving healthcare education, improved efficiency of clinical processes (e.g., documentation), addressing ethical concerns (e.g., patient privacy and consent), supporting research tasks (e.g., data analysis, manuscript preparation), mitigating ChatGPT output biases, improving patient education and engagement, and developing standardized assessment protocols for ChatGPT utility in healthcare.&#x0D; Conclusions: The current review highlighted key areas to be prioritized in assessment of ChatGPT utility in healthcare. Interdisciplinary collaborations and standardizing methodologies are needed to synthesize robust evidence in these studies. Based on these recommendations and the promising potential of ChatGPT on healthcare, JMJ launched a call for papers for a special issue entitled “Evaluating Generative AI-Based Models in Healthcare”.

Priority setting: women's health topics in multiple sclerosis.

A scoping review found that most studies on women's health in multiple sclerosis (MS) focused on pregnancy, fetal/neonatal outcomes and sexual dysfunction. Few studies addressed menopause, contraception, gynecologic cancers/cancer screening. However, the perceived relative importance of these knowledge gaps to people living with MS and other partners is unknown. We engaged a range of partners, including people living with MS, health care providers, researchers, and patient advocacy groups, to set priorities for future research in women's health in MS. We employed a three-step global engagement process. First, we identified which broad research topics relevant to women's health in MS were of highest priority using two surveys. Second, we developed specific research questions within these topics using focus groups. Finally, we prioritized the research questions with a third survey. Overall, 5,266 individuals responded to the initial surveys [n = 1,430 global survey, mean (SD) age 50.0 (12.6), all continents; n = 3,836 North American Research Committee on Multiple Sclerosis survey, mean (SD) age 64.8 (9.6), United States]. Menopause, sexual dysfunction, pregnancy, gynecologic cancer/cancer screening, hormones and parenthood were identified as the most important topics. Focus groups generated 80 potential research questions related to these topics. In the final survey 712 individuals prioritized these questions. The highest priority questions in each research topic were: (i) How do perimenopause and menopause affect disease activity, course, response to disease-modifying treatment and quality of life in MS; (ii) What are the most effective strategies for managing issues around sexual intimacy, including related to low sexual desire, changes in physical function, and MS symptoms; (iii) Are there long-term effects of disease-modifying therapies on the children of persons with MS; (iv) What are the short and long-term effects of disease-modifying drugs on gynecologic cancer risk, particularly for high efficacy disease-modifying drugs and hematopoietic stem cell transplantation; (v) Are there hormone related treatments that can stabilize fluctuations in MS symptoms; and (vi) How does MS fatigue impact parenting strategies. Priorities for research relating to women's health issues for persons with MS have been delineated using a collaborative process with key partners. Alignment of future research with these priorities should be monitored.

Psychometric validation of the Dysmorphic Concern Questionnaire (DCQ) into Arabic

BackgroundResearch on dysmorphic concerns (DC) in Arabic-speaking contexts is hampered by the lack of validated tools. Because DC are culturally dependent, psychometrically sound measures are needed at the national level to closely and accurately investigate the construct in specific societies and populations. The purpose of the current research was to investigate the psychometric properties of Dysmorphic Concern Questionnaire (DCQ) in its Arabic translation in Lebanese adults.MethodsThe study involved 515 participants (69.9% females, mean age of 27.55 ± 10.92 years) who completed a self-report, web-based questionnaire.ResultsConfirmatory factor analysis indicated excellent construct validity, as the one-factor structure of the Arabic DCQ fits well with the data. McDonald’s omega was 0.89 in our sample, evidencing an excellent level of internal consistency. Furthermore, the results from the multigroup analysis showed that the DCQ holds similar structural model between genders at the metric, configural, and scalar levels. Finally, DC levels correlated inversely with body appreciation and self-esteem and positively with disordered eating symptoms, thus supporting the concurrent and convergent validity of the Arabic DCQ.ConclusionThe DCQ translated into Arabic appears to have a valid self-assessment measure to capture the presence of DC manifestations. It is anticipated that the Arabic DCQ will be advantageous for healthcare professionals and researchers working with Arabic-speaking people around the world.