Target Sample Size Research Articles

Assessing the use of the triglyceride-glycemic index (TyG), neutrophil-lymphocyte Ratio (NLR), and platelet-lymphocyte Ratio (PLR) in distinguishing benign and malignant tumors among patients with complaints of breast mass

IntroductionBreast cancer is a prevalent global health concern characterized by uncontrolled cell growth in breast tissue. In 2020, approximately 2.3 million cases were reported worldwide, with 162,468 new cases and 87,090 fatalities documented in India in 2018. Early diagnosis is crucial for reducing mortality. Our study focused on the use of markers such as the triglyceride-glycemic index and hematological markers to distinguish between benign and malignant breast masses. MethodsA prospective cross-sectional study included female patients with breast mass complaints. The target sample size was 200. Data collection included medical history, clinical breast examination, mammography, cytological assessment via fine-needle aspiration cytology (FNAC), and blood sample collection. The analyzed parameters included neutrophil-to-lymphocyte Ratio (NLR), platelet-to-lymphocyte Ratio (PLR), and triglyceride-glycemic index (TyG). Histopathological examination confirmed the FNAC results. Statistical analysis including propensity score matching, Kolmogorov–Smirnov tests, Mann–Whitney U tests, receiver's operator curve (ROC) analysis, and logistic regression models was conducted using SPSS and R Software. Additional validation was performed on 25 participants. ResultsThis study included 200 participants. 109 had benign tumors and 91 had malignant tumors. Propensity score matching balanced covariates. NLR did not significantly differ between the groups, while PLR and TyG index differed significantly. NLR correlated strongly with the breast cancer stage, but not with the BI-RADS score. PLR and TyG index showed moderate positive correlations with the BI-RADS score. ROC analysis was used to determine the optimal cutoff values for PLR and TyG index. Logistic regression models combining PLR and TyG index significantly improved malignancy prediction. ConclusionsTyG index and PLR show potential as adjunctive markers for distinguishing breast masses. NLR correlated with cancer stage but not lesion type. Combining TyG and PLR improves prediction, aiding clinical decisions, but large-scale multicenter trials and long-term validation are required for clinical implementation.

Self-management including exercise, education and activity modification compared to usual care for adolescents with Osgood-Schlatter (the SOGOOD trial): protocol of a randomized controlled superiority trial.

Osgood-Schlatter is the most frequent growth-related injury affecting about 10% of physically active adolescents. It can cause long-term pain and limitations in sports and physical activity, with potential sequela well into adulthood. The management of Osgood-Schlatter is very heterogeneous. Recent systematic reviews have found low level evidence for surgical intervention and injection therapies, and an absence of studies on conservative management. Recently, a novel self-management approach with exercise, education, and activity modification, demonstrated favorable outcomes for adolescents with patellofemoral pain and Osgood-Schlatter in prospective cohort studies. The aim of this trial is to assess the effectiveness of the novel self-management approach compared to usual care in improving self-reported knee-related function in sport (measured using the KOOS-child 'Sport/play' subscale) after a 5-month period. This trial is a pragmatic, assessor-blinded, randomized controlled trial with a two-group parallel arm design, including participants aged 10-16 years diagnosed with Osgood-Schlatter. Participants will receive 3 months of treatment, consisting of either usual care or the self-management approach including exercise, education, and activity modification, followed by 2 months of self-management. Primary endpoint is the KOOS-child 'Sport/play' score at 5 months. This protocol details the planned methods and procedures. The novel approach has already shown promise in previous cohort studies. This trial will potentially provide much-needed level 1 evidence for the effectiveness of the self-management approach, representing a crucial step towards addressing the long-term pain and limitations associated with Osgood-Schlatter. Clinicaltrials.gov: NCT05174182. Prospectively registered December 30th 2021. Date of first recruitment: January 3rd 2022. Target sample size: 130 participants.

Assessment of health status, utilization, and out-of-pocket expenditure among the elderly in Ngestiharjo, Bantul, Yogyakarta

Background: As the population ages, it is increasingly crucial to develop community-centered health interventions. This study aims to describe and assess sociodemographic information, health characteristics, health utilization, and out-of-pocket expenses among older people in Ngestiharjo Village, Bantul, Yogyakarta. It was part of an initiative to empower community health workers to understand and address the health needs of older people. Methods: A cross-sectional survey was conducted from April to July 2023 involving 330 participants, with a targeted sample size of 356 elderly individuals. Data on sociodemographics, health status, health utilization, and expenditure were collected through interviews with older people or their companions. Results: Preliminary data showed that most participants were female (58.77%), married (64.91%), and primarily received health information from health workers (47.37%). Hypertension and joint and bone diseases were prevalent, with 16.67% likely experiencing depression. 11.4% of the respondents were hospitalized in the past year, with an average of 2.15 hospitalizations. Private hospitals (69.23%) were the most common healthcare facilities used for hospitalization, and 76.92% consistently utilized health insurance. The average out-of-pocket expenditure for hospitalization was 437,500 IDR. Community health centers (36.36%) and private hospitals (45.45%) were predominantly used for outpatient care, and 77.27% always used health insurance. The average out-of-pocket expenditure for outpatient care was 126,200 IDR. Conclusions: The study underscores the importance of empowering community health workers to effectively disseminate health information, fortify integrated health posts, manage common health issues, and tackle barriers to healthcare utilization and expenditures among older people.

Evaluation of nuclear morphometry in exfoliative cytology of buccal mucosa in patients with high risk of oral cancer

BackgroundOral cancer poses a significant global health burden, with India having the highest prevalence. Effective detection is crucial in effective prevention. This study aimed to evaluate nuclear morphometric parameters (NMPs) in buccal mucosa cells of smokers, correlate NMPs with dysplasia, establish cut off values for grading dysplasia, and investigate the relationship between NMPs and smoking. MethodsAfter obtaining ethical approval and informed consent, patients were recruited from the outpatient department of our institution. A target sample size of 250 was calculated. The data included smoking exposure quantified in pack-years, nuclear morphometric analysis (NMA) of buccal mucosa cells obtained through oral cytology using Image J, and the severity of dysplasia of the slides assessed by pathologists. Statistical analysis assessed the impact of dysplasia and the association between nuclear characteristics and smoking exposure. Receiver operating characteristic (ROC) plots determined the potential of these parameters to distinguish dysplasia levels. ResultsSignificant differences in NMPs were observed among different smoking groups. Dysplasia severity had a significant correlation with NMPs, and strong correlations were found between NMPs and lifetime smoking exposure. ROC analysis established cut off values for NMPs with good sensitivity and specificity for classifying dysplasia severity. ConclusionsThis study highlights the potential of NMA as a tool for oral cancer screening. NMPs can distinguish dysplasia severity and correlate with tobacco (smoking). The efficiency of NMA in a non-invasive oral cytology offers promise for patient-centered screening Additionally, the findings suggest future applications in telepathology and the potential for AI integration in automated screening after conducting multicentric large-scale studies.

Evaluating a Remotely Delivered Cardio-Oncology Rehabilitation Intervention for Patients With Breast Cancer (REMOTE-COR-B): Protocol for a Single-Arm Feasibility Trial.

Exercise rehabilitation is a promising strategy for reducing cardiovascular disease risk among patients with breast cancer. However, the evidence is primarily derived from programs based at exercise centers with in-person supervised delivery. Conversely, most patients report a preference for home-based rehabilitation. As such, there is a clear need to explore strategies that can provide real-time supervision and coaching while addressing consumer preferences. Evidence from cardiac rehabilitation has demonstrated the noninferiority of a smartphone-based telerehabilitation approach (REMOTE-CR) to improve cardiorespiratory fitness in people with cardiovascular disease compared to a center-based program. This study aims to assess the feasibility, safety, and preliminary efficacy of the REMOTE-CR program adapted for patients with breast cancer at risk of cardiotoxicity (REMOTE-COR-B). We will also assess the satisfaction and usability of REMOTE-COR-B. We will conduct a single-arm feasibility study of the REMOTE-COR-B program among patients with stage I-III breast cancer who are at risk of cardiotoxicity (taking treatment type and dose, as well as other common cardiovascular disease risk factors into account) and who are within 24 months of completing primary definitive treatment. Participants (target sample size of 40) will receive an 8-week smartphone-based telerehabilitation exercise program involving remotely delivered real-time supervision and behavior change support. The platform comprises a smartphone and wearable heart rate monitor, as well as a custom-built smartphone app and web application. Participants will be able to attend remotely monitored exercise sessions during set operating hours each week, scheduled in both the morning and evening. Adherence is the primary outcome of the trial, assessed through the number of remotely monitored exercise sessions attended compared to the trial target (ie, 3 sessions per week). Secondary outcomes include additional trial feasibility indicators (eg, recruitment and retention), safety, satisfaction, and usability, and objective and patient-reported efficacy outcomes (cardiovascular fitness, quality of life, fatigue, self-reported exercise, self-efficacy, habit strength, and motivation). Adherence, feasibility, and safety outcomes will be assessed during the intervention period; intervention satisfaction and usability will be assessed post intervention; and objective and patient-reported efficacy outcomes will be assessed at baseline, post intervention (2-month postbaseline assessment), and at follow-up (5-month postbaseline assessment). Recruitment for this trial commenced in March 2023, and 7 participants had been recruited as of the submission of the manuscript. The estimated completion date for the project is October 2024, with results expected to be published in mid-2025. The REMOTE-COR-B intervention is a novel and promising approach to providing exercise therapy to patients with breast cancer at risk of cardiotoxicity who have unique needs and heightened safety risks. This project will provide important information on the extent to which this approach is satisfactory to patients with breast cancer, safe, and potentially effective, which is necessary before larger-scale research or clinical projects. Australian New Zealand Clinical Trials Registry ACTRN12621001557820; www.anzctr.org.au/ACTRN12621001557820.aspx. DERR1-10.2196/53301.

Leading under pressure: a contextualised development approach

PurposeThe study’s aim was to design and test a leadership development approach using blended learning, to equip leaders for strengthening their own resilience and that of their teams.Design/methodology/approachA contextualised leadership development intervention was produced and evaluated following the principles of design-based research. Participants were from three organisations that work internationally to address the impact of economic disadvantage. Initial research used the behavioural event interview technique. Online assessment incorporated measures of situational judgement, emotion recognition and attributional style. Validity measures were multi-rater feedback (criterion), and NEO-PI 3 (construct). Individual feedback and a simulation-based peer workshop were followed by a four-to-six month period of experience-driven development and a final peer workshop for consolidating and evaluating learning outcomes.FindingsThe online assessment was a valid measure of leaders’ personal resilience resources and their resilience-building capability. Overall, the intervention improved participants’ understanding of, and engagement with, the processes of strengthening individual and collective (team) resilience.Research limitations/implicationsThe target sample size for the study was relatively small, to ensure it would be practical to replicate the approach when designing similar interventions for a senior leadership population in other contexts. Significant results provided robust evidence for the validity of the assessment approach. Findings for the workshops and experience-driven development phase were more tentative, but the value of the design iterations was clearly demonstrated.Practical implicationsThe leadership development approach is suitable for application in other organisations, if similar principles are followed to produce and evaluate materials relevant to each broad sector context. Roll-out is cost-effective, with relatively few hours of blended or virtual delivery supporting experience-driven learning.Social implicationsThe impact leaders have on the wellbeing of those who report to them is well established, but less has been done to develop and formally evaluate practical, cost-effective interventions to improve this impact. The approach validated in this study can be applied more widely to benefit employee wellbeing as well as performance.Originality/valueThe study developed and evaluated a new approach to preparing leaders for the challenge of building team resilience, an aspect of leadership capability that has been given relatively little attention to date.

Protocol for evaluating the effects of the Reducing Cardiometabolic Diseases Risk dietary pattern in the Chinese population with dyslipidaemia: a single-centre, open-label, dietary intervention study

IntroductionCardiometabolic disease (CMD) is the leading cause of mortality in China. A healthy diet plays an essential role in the occurrence and development of CMD. Although the Chinese heart-healthy diet...

Strategic Assessment of Intricacies in Healthcare Cyber Security: Analyzing Distinctive Challenges, Evaluating Their Ramifications on Healthcare Delivery, and Proposing Advanced Mitigation Strategies

Healthcare firms have access to highly sensitive and valuable data, such as patient health records and payment card information. They are also becoming more reliant on Internet of Medical Things (IoMT) devices to provide treatment, and assaults on this networked equipment can result in data breaches or disruptions to crucial care of patients. Hence there is need to critically assess the intricacies in healthcare cyber security by analyzing the unique challenges facing healthcare sector, their impact on healthcare delivery and suggest some effective cyber security measures to mitigate the identified Cyber security challenges facing health care sector. The research employs a quantitative method by using the descriptive and survey approach through the use of questionnaires to elicit and gather relevant information regarding the Unique Cyber security Challenges in the Healthcare Industry. The descriptive method was used to achieve the objectives of the study while the survey technique was used to get qualitative information from respondents about effect of those cyber security challenges in the health care industry. The target sample size used for this study was 1300. However, only 980 responses were recovered and used for the analysis. Future research work suggested that strong encryption procedures can be developed and implemented for healthcare security, sophisticated anomaly detection tools can be incorporated, and cooperative frameworks for information exchange across the healthcare ecosystem could be established. Also the suggested effective measures to mitigate cyber security challenges in healthcare sector can be implemented in order to secure the patient sensitive and valuable data.

Intake of energy and macronutrients in the diets of 11–13-year-old schoolchildren living in Delhi India

National surveys in India, through measures of anthropometry and biomarkers, have identified a triple burden of malnutrition (undernutrition, micronutrient deficiencies and overnutrition) in adolescents(1). However, there is a dearth of high-quality data on individual dietary behaviour of this population(2) and the importance of sub-national dietary surveys in filling this gap has been identified(3). The objective of this study was to assess the intake of energy (E) and macronutrients and the contribution of macronutrients to E in a random sample of 11–13-year-old schoolchildren in Delhi, India. Method: The study was approved by The University of Adelaide Human Research Ethics Committee and the Independent Ethics Committee of the Centre for Chronic Disease Control, New Delhi. The target sample size of 360 was based on a ± 5% margin of error in estimated sugars intakes. Using the list of private schools in Delhi (n = 1374), a statistician external to the research team generated a random sample of 150 schools stratified by districts (n = 11). Using this list, schools were invited to participate, and recruitment continued until 10 schools consented. Teachers shared study information with parents; interested parents filled in the online consent form. Assent was obtained from schoolchildren. Participants recorded all food and drink consumed over three consecutive days, including one weekend day, in a food diary. Information recorded was entered into an online dietary assessment tool, Intake24 Southeast Asia version, during an interview with each participant. The Intake24 database of over 2400 food photographs of more than 100 foods was used to ascertain portion size. The Intake24 database converts food and drink reported into the intake of nutrients through integrated food compositional tables. Of 514 pupils providing consent, 393 participants (76.4%) (169 girls, 224 boys) completed the study. The median daily E intake was 10.8 (IQR 9.0 −12.5) MJ for girls, and 12.3 (IQR 10.3- 15.2) MJ for boys. For the 97 girls and 144 boys providing body weight data, Physical Activity Level ratios were 2.0 and 2.1 respectively. The median daily intakes for girls were: protein 64.6 (IQR 54.8-79.3) g; carbohydrate 336.5 (IQR 285.3- 393.6) g; and saturated fat 45.6 (IQR 34.8-58.3) g. The respective values in boys were: protein 74.4 (IQR 61.4; 89.4) g; carbohydrate 379.6 (IQR 317.8; 461.8) g; and saturated fat 54.6 (IQR 41.9-69.5) g. There were no significant between-gender differences in percent E from protein (10.2 (IQR 9.2; 11.4)), or carbohydrate (52.4 (IQR 48.7; 56.7)). Girls obtained less E from saturated fat (16.1 (IQR 11.0-18.2) compared with boys 16.3 (IQR 14.2 - 19.1) (P<0.05). In conclusion, in this sample of adolescents from private schools in Delhi, E intake was above FAO recommended levels and median total fat intake exceeded the recommended threshold of 35%(4).

Does experience of music enhance olfaction: music as a potential nutrition intervention?

Olfaction, the sense of smell, is under recognised and underappreciated despite being vital in wellbeing. It confers a major influence on the feeding process being the major contributor of flavour and has a direct involvement in the cephalic phase responses. Along with its influence on food and nutrition, olfaction is directly associated with cognitive function and impacts social communication and safety(1). Loss of olfactory acuity, commonly occurring in aging and frailty, significantly influences dietary behaviour and food selection(2). Unlike the senses of vision and audition, interventions are lacking. We propose in a proof-of-concept that crossmodal integration of olfaction and audition could inhibit olfactory decline in lifelong musicians through encouraging neuroplasticity of the olfactory brain centres. Ethical approval was obtained from The University of Adelaide Human Research Ethics Committee. Male musicians with a lifetime experience of music (ME) and naïve non-musicians (NM) aged 55 years and over were recruited through music organisations and controls through the Australian Men’s Shed network. The initial target sample size was twenty per cohort. Olfactory acuity was assessed with Sniffin’ sticks® (Odofin, Groningen, The Netherlands), a well validated system of a battery of three tests regimes. Sniffin’ sticks represent ‘felt tipped pens’ impregnated with odourants presented 20mm below the nose of participants who were then prompted to ‘sniff’. Assays determined participant ‘Threshold’, ‘Discrimination’ and ‘Identification’ of test odours (3). Measurement of Threshold and Discrimination were undertaken in triplet fifteen seconds apart with eyes closed; measurement of Threshold being conducted in an ascending ‘staircase’ to detect lowest odour concentration detectable, whereas measurement of Discrimination selected the ‘odd-man-out’ of a triplet comprising two identical and one different odour. Measurement of Identification, with eyes open, selected the odour of a single ‘pen’ from a prompt list of four. All tests demanded selection. Each of the test batteries were scored out of sixteen along with total aggregate of Threshold, Discrimination, and Identification (TDI). Twenty-six participants completed the study (18 ME and 8 NM); numbers were limited owing to active COVID-19. Mean and standard deviations (SD) of Threshold, Discrimination, Identification and TDI were derived and compared between groups using ‘t’-test. For ME, Threshold, Discrimination, and Identification values were 6.2 (SD ± 3.7), 10.6 (SD ± 1.9), and 12.9 (SD ± 1.6). The respective values for NM were 5.0 (SD ± 2.3), 8.8(SD ± 2.9), and 10.8 (SD ± 2.5). The ME group showed a significantly higher Discrimination (p = 0.164). Significant differences were not seen for Threshold, Identification, and overall TDI scores, however the small sample size may have accounted for this. Based on this proof-of-concept, further exploration of music is warranted as an intervention to enhance olfactory acuity to potentially improve the intake of food and nutrition, and enrich pleasure of eating and drinking, and quality of life.

Intake of free sugars by 11–13-year-old schoolchildren living in Delhi, India

Intake of free sugars is associated with a risk of non-communicable diseases including dental caries, and authoritative organisations recommend limiting intake to <5% energy intake (E) or lower (1, 2). National surveys of schoolchildren in India indicate the prevalence of obesity is rising >10%/year(3) and that 52.5% of young adolescents are affected with dental caries(4), yet, there is a dearth of data on dietary intake of sugars by this population. The objective of this research was to assess the intake of total and free sugars, and the contribution of food sources to free sugars intake, in a random sample of 11–13-year-old schoolchildren in Delhi, India. The study was approved by The University of Adelaide Human Research Ethics Committee and the Independent Ethics Committee of the Centre for Chronic Disease Control, New Delhi. The target sample size of 360 was based on a ± 5% margin of error in estimated sugars intake. A statistician external to the research team generated a random sample of 150 schools stratified by district (n = 11). Schools were recruited in turn from the list until 10 schools had consented. Teachers shared study information with parents who were invited to complete an online consent form. Child assent was obtained before data collection. Participants recorded all food and drink consumed over three consecutive days, including one weekend day, in a food diary. The information recorded was entered into an online dietary assessment tool, Intake24 (Southeast Asia version), during an interview with each participant during which portion size was ascertained with reference to the database of over 2400 food photographs of more than 100 foods. The Intake24 database converted food and drink reported into the intake of total and free sugars through integrated food compositional tables. Of 514 pupils providing consent, 393 participants (76.5%) (169 girls, 224 boys) completed the study. In girls, the median (IQR) daily intakes of total and free sugars were 95.0 (70.1-120.2) g/day and 43.0 (28.1-68.5) g/day respectively. The corresponding values in boys were significantly higher at 104.0 (80.2-138.7) g/day and 53.1 (34.1-76.5) g/day (p = 0.004). No between-gender difference was observed in the median percent contribution of sugars to E: total and free sugars contributed 14.9% (IQR 11.4-18.1%) and 7.1% (IQR 4.8-10.1%) respectively. The percent contribution of the main sources of sugars to free sugars intake were: (i) Sugars Preserves and Syrups (31.2% (IQR. 9.6-51.7%)); (ii) Cakes and Biscuits (13.7% (IQR 0-26.4%)); (iii) Desserts (5.4% (0-17.5%)) and (iv) Sugar-Sweetened Beverages and Juices (2.1% (IQR 0-15.7%)). In conclusion, in this sample of 11-13-year-old schoolchildren from Delhi, free sugars intake was above the WHO <5% E threshold. Forms of sugars that are added to foods by the consumer made the largest contribution to intake.

A survey of surveys: an evaluation of the quality of published surveys in neurosurgery.

Surveys generate valuable data in epidemiologic and qualitative clinical research. The quality of a survey depends on its design, the number of responses it receives, and the reporting of the results. In this study, we aimed to assess the quality of surveys in neurosurgery. Neurosurgical surveys published between 2000 and 2020 (inclusive) were identified from PubMed. Various datapoints regarding the surveys were collated. The number of citations received by the papers was determined from Google Scholar. A 6-dimensional quality assessment tool was applied to the surveys. Parameters from this tool were combined with the number of responses received to create the survey quality score (SQS). A total of 618 surveys were included for analysis. The target sample size correlated with the number of responses received. The response rate correlated positively with the target sample size and the number of reminders sent and negatively with the number of questions in the survey. The median number of authors on neurosurgery survey papers was 6. The number of authors correlated with the SQS and the number of citations received by published survey papers. The median normalized SQS for neurosurgical surveys was 65%. The nSQS independently predicted the citations received per year by surveys. The modifiable factors that correlated with improvements in survey design were optimizing the number of questions, maximizing the target sample size, and incorporating reminders in the survey design. Increasing the number of contributing authors led to improvements in survey quality. The SQS was validated and correlated well with the citations received by surveys.

Computer-Facilitated Screening and Brief Intervention for Alcohol Use Risk in Adolescent Patients of Pediatric Primary Care Offices: Protocol for a Cluster Randomized Controlled Trial.

Alcohol and other substance use disorders usually begin with substance use in adolescence. Pediatric primary care offices, where most adolescents receive health care, are a promising venue for early identification of substance use and for brief intervention to prevent associated problems and the development of substance use disorder. This study tests the effects of a computer-facilitated screening and brief intervention (cSBI) system (the CRAFFT [Car, Relax, Alone, Forget, Family/Friends, Trouble] Interactive System [CRAFFT-IS]) on heavy episodic drinking, riding with a driver who is substance impaired, or driving while substance impaired among adolescents aged 14 to 17 years presenting for a well visit at pediatric primary care practices. We are conducting a cluster randomized controlled trial of the CRAFFT-IS versus usual care and recruiting up to 40 primary care clinicians at up to 20 pediatric primary care practices within the American Academy of Pediatrics (AAP) Pediatric Research in Office Settings network. Clinicians are randomized 1:1 within each practice to implement the CRAFFT-IS or usual care with a target sample size of 1300 adolescent patients aged 14 to 17 years. At study start, intervention clinicians complete web-based modules, trainer-led live sessions, and mock sessions to establish baseline competency with intervention counseling. Adolescents receive mailed recruitment materials that invite adolescents to complete an eligibility survey. Eligible and interested adolescents provide informed assent (parental permission requirement has been waived). Before their visit, enrolled adolescents seeing intervention clinicians complete a self-administered web-based CRAFFT screening questionnaire and view brief psychoeducational content illustrating substance use-associated health risks. During the visit, intervention clinicians access a computerized summary of the patient's screening results and a tailored counseling script to deliver a motivational interviewing-based brief intervention. All participants complete previsit, postvisit, and 12-month follow-up study assessments. Primary outcomes include past 90-day heavy episodic drinking and riding with a driver who is substance impaired at 3-, 6-, 9-, and 12-month follow-ups. Multiple logistic regression modeling with generalized estimating equations and mixed effects modeling will be used in outcomes analyses. Exploratory aims include examining other substance use outcomes (eg, cannabis and nicotine vaping), potential mediators of intervention effect (eg, self-efficacy not to drink), and effect moderation by baseline risk level and sociodemographic characteristics. The AAP Institutional Review Board approved this study. The first practice and clinicians were enrolled in August 2022; as of July 2023, a total of 6 practices (23 clinicians) had enrolled. Recruitment is expected to continue until late 2024 or early 2025. Data collection will be completed in 2025 or 2026. Findings from this study will inform the promotion of high-quality screening and brief intervention efforts in pediatric primary care with the aim of reducing alcohol-related morbidity and mortality during adolescence and beyond. ClinicalTrials.gov NCT04450966; https://www.clinicaltrials.gov/study/NCT04450966. DERR1-10.2196/55039.

Investigator choice of standard therapy versus sequential novel therapy arms in the treatment of relapsed follicular lymphoma (REFRACT): study protocol for a multi-centre, open-label, randomised, phase II platform trial

BackgroundRelapsed or refractory follicular lymphoma (rrFL) is an incurable disease associated with shorter remissions and survival after each line of standard therapy. Many promising novel, chemotherapy-free therapies are in development, but few are licensed as their role in current treatment pathways is poorly defined.MethodsThe REFRACT trial is an investigator-initiated, UK National Cancer Research Institute, open-label, multi-centre, randomised phase II platform trial aimed at accelerating clinical development of novel therapies by addressing evidence gaps. The first of the three sequential novel therapy arms is epcoritamab plus lenalidomide, to be compared with investigator choice standard therapy (ICT). Patients aged 18 years or older with biopsy proven relapsed or refractory CD20 positive, grade 1-3a follicular lymphoma and assessable disease by PET-CT are eligible. The primary outcome is complete metabolic response by PET-CT at 24 weeks using the Deauville 5-point scale and Lugano 2014 criteria. Secondary outcomes include overall metabolic response, progression-free survival, overall survival, duration of response, and quality of life assessed by EQ-5D-5 L and FACT-Lym. The trial employs an innovative Bayesian design with a target sample size of 284 patients: 95 in the ICT arm and 189 in the novel therapy arms.DiscussionWhilst there are many promising novel drugs in early clinical development for rrFL, understanding the relative efficacy and safety of these agents, and their place in modern treatment pathways, is limited by a lack of randomised trials and dearth of published outcomes for standard regimens to act as historic controls. Therefore, the aim of REFRACT is to provide an efficient platform to evaluate novel agents against standard therapies for rrFL. The adaptive Bayesian power prior methodology design will minimise patient numbers and accelerate trial delivery.Trial registrationClinicalTrials.gov: NCT05848765; 08-May-2023.EudraCT2022-000677-75; 10-Feb-2022.

The Effect of Organizational Flexibility on Organizational Ambidexterity in Higher Education Institutions in Iraq

The purpose of this research is to examine how different dimensions of organizational flexibility (strategic, structural, and operational) impact organizational ambidexterity within the higher education sector in Iraq. To collect data, a survey instrument is used and a quantitative approach is adopted, with 85 academic staff members participating out of a targeted sample size of 295 lecturers from colleges and institutes within Duhok Polytechnic University (DPU) located in Duhok city, Iraqi Kurdistan Region. Structural Equation Modelling is utilized to determine the direction of the relationship between the variables. Based on the study, it was found that Structure Flexibility has a positive and significant impact on both Exploration and Exploitation of organizational ambidexterity. Additionally, Operational Flexibility also had a significant and positive effect on Exploration and Exploitation. However, the effect of Strategy Flexibility on organizational ambidexterity (Exploration and Exploitation was not significant and surpassed the significance level of 0.05. In addition to the findings, this study addresses the key policy implications, limitations, and recommendations for future research regarding higher education institutions.

Promoting Return to Work After Vocational Rehabilitation Using a Work-Related Fitness App: Protocol for a Cluster-Randomized Controlled Trial.

Retraining programs in vocational rehabilitation are often characterized by a low level of physical activity, even when targeting jobs with primarily physical demands. They might therefore be accompanied by a decline in functional capacity if the lack of physical activity is not compensated by increased activity during leisure time. The implementation of a work-related exercise app might be a promising approach to promoting a return to work in vocational rehabilitation. We developed the "WORKout-app" which provides exercise plans based on a comparison of the physical demands of the retraining profession and the current functional capacity. The aim of this study is to examine the effects of app-based exercise during vocational rehabilitation on perceived work ability (primary outcome), occupational self-efficacy, days of sick leave, and return to work (secondary outcomes). We conducted a cluster-randomized controlled trial with 2 arms (intervention: WORKout-app vs control: treatment as usual) in 4 cohorts of 5 vocational rehabilitation centers in Germany. Participants are nested within retraining classes per vocational rehabilitation center and per cohort assigned to either the intervention condition or the control condition. The target sample size at the participant level is 598. Measurement time points include baseline, the end of rehabilitation, 3 months after the end of rehabilitation, and 6 months after the end of rehabilitation. Linear and generalized linear mixed-effects models are performed to test for treatment differences in outcomes. This study is funded by the German Federal Pension Insurance. The trial is registered with the German Clinical Trials Register (DRKS00030775) and approved by the Ethics Committee of the German Sport University Cologne (145/2022). The findings of the study will inform researchers and practitioners about the effectiveness of an exercise app developed to counteract the effects of physical inactivity during vocational rehabilitation. DERR1-10.2196/50200.

The IRELAnD study—investigating the role of early low-dose aspirin in diabetes mellitus: a double-blinded, placebo-controlled, randomized trial

Although aspirin therapy is being increasingly advocated with the intention of risk modification for a wide range of pregnancy complications, women with prepregnancy diabetes mellitus are commonly excluded from clinical trials. The primary aim of this study was to examine the effect of aspirin therapy on a composite measure of adverse perinatal outcome in pregnancies complicated by pregestational diabetes mellitus. A double-blinded, placebo-controlled randomized trial was conducted at 6 university-affiliated perinatology centers. Women with type 1 diabetes mellitus or type 2 diabetes mellitus of at least 6 months' duration were randomly allocated to 150-mg daily aspirin or placebo from 11 to 14 weeks' gestation until 36 weeks. Established vascular complications of diabetes mellitus, including chronic hypertension or nephropathy, led to exclusion from the trial. The primary outcome was a composite measure of placental dysfunction (preeclampsia, fetal growth restriction, preterm birth <34 weeks' gestation, or perinatal mortality). The planned sample size was 566 participants to achieve a 35% reduction in the primary outcome, assuming 80% statistical power. Secondary end points included maternal and neonatal outcomes and determination of insulin requirements across gestation. Data were centrally managed using ClinInfo and analyzed using SAS 9.4. The 2 treatment groups were compared using t tests or chi-square tests, as required, and longitudinal data were compared using a repeated-measures analysis. From February 2020 to September 2022, 191 patients were deemed eligible, 134 of whom were enrolled (67 randomized to aspirin and 67 to placebo) with a retrospective power of 64%. A total of 101 (80%) women had type 1 diabetes mellitus and 25 (20%) had type 2 diabetes mellitus. Reaching the target sample size was limited by the impact of the COVID-19 pandemic. Baseline characteristics were similar between the aspirin and placebo groups. Treatment compliance was very high and similar between groups (97% for aspirin, 94% for placebo). The risk of the composite measure of placental dysfunction did not differ between groups (25% aspirin vs 21% placebo; P=.796). Women in the aspirin group had significantly lower insulin requirements throughout pregnancy compared with the placebo group. Insulin requirements in the aspirin group increased on average from 0.7 units/kg at baseline to 1.1 units/kg by 36 weeks' gestation (an average 83% within-patient increase), and increased from 0.7 units/kg to 1.3 units/kg (a 181% within-patient increase) in the placebo group, over the same gestational period (P=.002). Serial hemoglobin A1c levels were lower in the aspirin group than in the placebo group, although this trend did not reach statistical significance. In this multicenter, double-blinded, placebo-controlled randomized trial, aspirin did not reduce the risk of adverse perinatal outcome in pregnancies complicated by prepregnancy diabetes mellitus. Compared with the placebo group, aspirin-treated patients required significantly less insulin throughout pregnancy, indicating a beneficial effect of aspirin on glycemic control. Aspirin may exert a plausible placenta-mediated effect on pregestational diabetes mellitus that is not limited to its antithrombotic properties.

Sociological determinants of adherence to continuous positive airway pressure in the management of sleep apnoea syndrome: protocol for a transdisciplinary, prospective observational study

IntroductionObstructive sleep apnoea syndrome (OSAS) is a chronic multiorgan pathology that has a negative impact on quality of life. Continuous positive airway pressure (CPAP) is the first-line treatment for OSAS....

Effectiveness and cost-effectiveness of a web-based cardiac rehabilitation programme for people with chronic stable angina: protocol for the ACTIVATE (Angina Controlled Trial Investigating the Value of the ‘Activate your heart’ Therapeutic E-intervention) randomised controlled trial

IntroductionChronic stable angina is common and disabling. Cardiac rehabilitation is routinely offered to people following myocardial infarction or revascularisation procedures and has the potential to help people with chronic stable...

The effect of age of acquisition on listening effort: Pupillometry and subjective measures

Bilinguals typically perform worse on speech-perception-in-noise relative to monolinguals, and bilinguals who learned the language later typically perform worse than those who learned it earlier. This decrement in performance has largely been attributed to the fact that both bilingualism and later acquisition result in comparatively less exposure to a language than monolingualism and earlier acquisition do. Though this effect of age of acquisition has been well-documented for speech recognition accuracy, less is known about how it affects listening effort. This study quantifies listening effort using three measures (pupil dilation, subjective effort ratings, and subjective fatigue ratings) for four listening conditions (quiet, easy, moderate, and hard). We collect these measures from four groups of participants: monolinguals, simultaneous bilinguals, early sequential bilinguals, and late bilinguals. Data collection is ongoing for a target sample size of 128 (32 per group). Based on related work, we expect greater listening effort for listeners with later ages of acquisition (e.g., late bilinguals relative to simultaneous bilinguals), and for that effect to increase with worsening acoustic quality (i.e., the hard relative to the easy condition). Preliminary results (N = 56) support these hypotheses. These data provide foundational insights into the relationship between bilingualism and listening effort.