Target Sample Size Research Articles

Study protocol for a cross-sectional online survey investigating patient preferences and experiences of waiting for elective cardiac surgery

IntroductionBeing on a waiting list for elective (planned) cardiac surgery can be physically and psychologically challenging for patients. Research suggests that stress associated with waiting for surgery is dependent on...

The influence of financial technology on profitability in Jordanian commercial banks

The aim of this study is to identify the influence of Financial Technology (FinTech) on profitability in Jordanian commercial banks. The convenience sample was surveyed using a descriptive cross-sectional approach. Questionnaires were used to collect the data. The study population consists of commercial banks. The tool was sent to employees of all Jordanian commercial banks through email, Facebook and Twitter in order to meet the researchers' target sample size of at least 381 participants. The data was analyzed using the Statistical Package for Social Sciences (SPSS) version 24. The results showed an impact of financial technology (financing, money transfers and lending) on banks' profitability. The results of this study demonstrate that the adoption of FinTech solutions by banks has a significant impact on their profitability and position. Financing, money transfer and lending are crucial in determining a bank's profitability and overall success. Therefore, this study contributed to the growth of a new model that connects financial technology through financing, money transfers and lending to profitability and it added many topics related to financial accounting technology for increasing profitability in Jordanian commercial banks.

Healthcare Expatriate Adjustment in Qatar: Analyzing Challenges and Opportunities.

The healthcare sector in the Middle East, particularly in Qatar, relies heavily on expatriate professionals. The successful adaptation of these expatriates to the local environment is crucialas it significantly affects their job satisfaction and the quality of care they deliver to patients. This study aimed to identify and analyze the key factors influencing the adjustment of healthcare expatriates in Qatar to their professional roles and the cultural context of the region. This study involved the use of a cross-sectional survey approach targeting healthcare professionals in Qatar, with a targeted sample size of 385 participantsselected to ensure a comprehensive representation of the expatriate workforce. The survey was disseminated through expatriate-specific WhatsApp groups from October 1, 2022, to December 31, 2022. It was structured to examine a variety of factors influencing expatriate adjustment, including age, gender, proficiency in the Arabic language, social support networks, job type, and length of stay in Qatar. The primary focus of this study is a thematic analysis of the respondents' free-text comments. These comments offer valuable insights into their experiences, both positive and negative, in adapting to life and work in Qatar. This study achieved a response rate of 51.69% (199 out of 385), with participants representing 10 nationalities, being predominantly aged between 35 and 44 years, and having spent four to seven years in Qatar. The majority of respondents were nurses and doctors, accounting for 83.9% of the sample. The following five main themes emerged from the analysis of 218 free-text comments: personal and family concerns, work-related matters, government and system-related challenges, social and cultural challenges, and Arabic language challenges. Although participants valued supportive employer practices in family relocation and professional environments, they encountered language barriers, bureaucratic complexities, and cultural adaptation challenges. The results of this study shed light on the multifaceted nature of expatriate adjustment in the healthcare sector of Qatar, highlighting the supportive elements and the obstacles encountered. They emphasize the need for comprehensive support mechanisms, including language training, streamlined bureaucratic processes, and cultural orientation programs, to facilitate successful and fulfilling expatriate experiences in the Middle Eastern healthcare context.

Do orthopaedics surgeons have any idea what predatory journals are?:(cross-sectional study)

ObjectiveThe legitimacy of published research confronts a real challenge posed by predatory journals. These journals not only distribute inadequately written articles but also undermine the prospects of acknowledgment and citation for high-quality content. It is essential, nevertheless, to differentiate between predatory journals and reputable open-access ones. A worldwide anti-predatory movement seeks to enhance awareness about such journals. Hence, our objective was to assess the awareness, attitudes, and practices of Sudanese orthopedic surgeons concerning both predatory and open-access publishing. MethodsConducted between January and April 2023, this cross-sectional electronic survey involved Sudanese orthopedic surgeons. The survey, comprising five domains to gauge knowledge, attitudes, and practices related to predatory and open-access publishing, was shared via the Sudanese Orthopedic Surgeons Association email distribution list among the 561 registered surgeons. The targeted sample size was 286. Categorical variables were reported using frequencies, while continuous variables were presented as medians and interquartile ranges. Nonparametric tests and ordinal regression were employed for inferential statistics. ResultsOf the 561 surgeons, 104 participants completed the questionnaire, resulting in a response rate of 18.5 %. Approximately 49% exhibited poor knowledge, with 56% unfamiliar with the term "predatory journals," and 74% unaware of Beall's list. Overall attitudes toward publication in open-access and predatory journals were neutral for 60% of participants, and only 26% demonstrated good overall publication practices. Higher knowledge scores positively correlated with attitude and practice scores. Ordinal regression analysis identified variables such as employment in university hospitals, higher academic rank, publication experience, and working in well-resourced countries as factors increasing the likelihood of higher knowledge, attitude, and practice scores. ConclusionThe majority of the study participants reported very low knowledge of predatory journals and their possible detrimental consequences on the integrity and quality of scientific publications. Therefore, educational efforts on the negative impact of predatory publication practices in orthopedics are needed.

Dukungan Keluarga pada Lansia di Panti Perlindungan dan Rehabilitasi Sosial Lanjut Usia (PPRSLU) Budi Sejahtera Banjarbaru Tahun 2023

The elderly represent a group of individuals undergoing the aging process, and their global population, including Indonesia, continues to increase, as reported by the WHO. Family social support plays a crucial role in maintaining the health and well-being of the elderly. This study aims to provide an overview of family support for the elderly in PPRSLU Budi Sejahtera Banjarbaru. The research adopts a quantitative approach with a target sample size of 89 individuals. However, due to convenience sampling, only 36 respondents could be included in the study. Data collection involved a modified family support questionnaire based on previous research. The result is Out of 36 respondents, 11 individuals (30.5%) reported receiving high family support, while 25 individuals (69.5%) experienced low family support. These findings indicate that the need for family support, particularly in instrumental and emotional aspects, is not entirely met among the elderly in PPRSLU Budi Sejahtera Banjarbaru. The majority of elderly individuals in PPRSLU Budi Sejahtera Banjarbaru experience limitations in family support. Therefore, it is crucial to address these issues and enhance the support provided to the elderly, especially in terms of instrumental and emotional support, to improve their quality of life.

Validation of an Anti-Müllerian Hormone Cutoff for Polycystic Ovarian Morphology in the Diagnosis of Polycystic Ovary Syndrome in the HARMONIA Study: Protocol for a Prospective, Noninterventional Study.

Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders in women and is diagnosed using the Rotterdam criteria, including diagnosis of polycystic ovarian morphology (PCOM) by transvaginal ultrasound (TVUS). Due to high cost, availability, and the impact of the operator and ultrasound equipment on the reliability of the antral follicle count (AFC) by TVUS, an unmet need exists for a diagnostic test to determine PCOM without TVUS. A strong positive correlation between elevated anti-Müllerian hormone (AMH) levels and AFCs has been demonstrated in women with PCOS. In addition, recent updates to the international evidence-based PCOS guidelines state that serum AMH can be used as an alternative to TVUS-determined AFC, in the diagnosis of PCOM. The retrospective APHRODITE study derived and validated an AMH cutoff of 3.2 ng/mL for the Elecsys AMH Plus or Elecsys AMH assays (Roche) to diagnose PCOM in patients with PCOS. This study aims to further validate, in an independent prospective cohort, the AMH cutoff (3.2 ng/mL) for PCOM determination, which was previously derived and validated in the APHRODITE study. This large, prospective, multicenter, population-based, noninterventional study will evaluate the previously established AMH cutoff for the determination of PCOM during the diagnosis of PCOS using the Elecsys AMH Plus immunoassay in an independent population. Participants were women born between July 1985 and December 1987 in Northern Finland; the study partially links to the Northern Finland Birth Cohort 1986. We assessed the enrolled women, determined with the 2023 PCOS Guidelines, for current PCOS status and divided them by phenotype if positive. Each participant had 1 study visit to collect serum samples, record clinical data, and undergo a gynecological examination including TVUS. All data were collected by highly trained midwives or trained gynecologists. Sensitivity, specificity, and agreement measures were used to validate the previously determined cutoff in the whole population and in subpopulations based on phenotype and relevant demographic or clinical factors. The minimum target sample size was approximately 1800 women, including approximately 10% with PCOS. At the time of manuscript submission, participant recruitment had concluded, and 1803 women were enrolled into the study. Data collection is complete and biostatistical analysis is planned for 2023. To limit variability, there were few TVUS operators and only 2 TVUS machines of the same type. Additionally, all women who were taking oral contraceptives were excluded from the primary analysis population. Selection bias was limited as this was a population-based study and participants were not seeking treatment for PCOS symptoms. Validating the AMH cutoff in a large, population-based study will provide further evidence on the utility of the Elecsys AMH Plus or Elecsys AMH assays in PCOM diagnosis as an alternative to TVUS. Measuring AMH for PCOM diagnosis could reduce delayed or missed diagnoses due to operator-dependent TVUS examinations. ClinicalTrials.gov NCT05527353; http://tinyurl.com/2f3ffbdz. DERR1-10.2196/48854.

AMBASSADOR Alliance A031501: Phase III randomized adjuvant study of pembrolizumab in muscle-invasive and locally advanced urothelial carcinoma (MIUC) vs observation.

LBA531 Background: Muscle-invasive urothelial carcinoma (MIUC) is an aggressive disease with high relapse rates. Neoadjuvant platinum-based chemotherapy (NAC) is the standard of care in patients (pts) who are cisplatin (Cis)-eligible. However, many pts are Cis-ineligible or have persistent muscle-invasive disease after NAC and surgery. We evaluated pembrolizumab (Pembro) as adjuvant therapy in pts with high-risk MIUC following surgical resection. Methods: The AMBASSADOR study is an open-label, randomized, phase III trial that enrolled pts with histologically confirmed MIUC of the bladder, upper tract, or urethra who (1) had ≥ pT2 and/or pN+ or margins+ at surgery (radical cystectomy, nephrectomy, nephroureterectomy, or ureterectomy) following NAC or (2) ≥ pT3 and/or pN+ or margins+ at surgery without NAC and were either Cis-ineligible or declined adjuvant Cis-based therapy. Pts were registered ≥4 to 16 weeks after surgery and randomized 1:1 to receive Pembro 200 mg every 3 weeks for 1 year or observation (Obs). Randomization was stratified by pathologic stage, centrally tested PD-L1 status, and prior NAC. The dual primary endpoints were disease-free survival (DFS) and overall survival (OS) with a target sample size of 739 pts and required 387 DFS and 320 OS events for final analysis. Secondary objectives included evaluation of DFS and OS in PD-L1-positive and -negative pts and assessing safety. Here we present the interim DFS and OS results. Results: Between 09/2017 and 08/2021 a total of 702 pts were randomized prior to early closure due to US FDA approval of nivolumab for MIUC pts: 354 pts to Pembro and 348 pts to Obs; 13.0% vs 21.6% withdrew from study without event in the Pembro vs Obs arms, respectively. 74 pts (21%) in the Obs arm received an immune checkpoint inhibitor. Median follow-up was 22.3 months (mos) for DFS and 36.9 mos for OS. The DFS endpoint (based on 319 events needed for interim analysis) crossed the efficacy boundary. Median DFS was 29.0 months (95% confidence interval (CI) 21.8‒not evaluable (NE)) with Pembro and 14.0 months (95% CI 9.7‒20.20) with Obs (hazard ratio (HR) 0.69 [95% CI 0.55–0.87]; p=0.0013). At the interim analysis (n = 257 events), median OS was 50.9 months (95% CI 43.9‒NE) with Pembro and 55.8 months (95% CI 53.3‒NE) with Obs (HR 0.98 [95% CI 0.76–1.26]; p=0.88). Grade 3+ adverse events occurred in 48.4% and 31.8% of pts in the Pembro and Obs arms, respectively. Conclusions: Adjuvant Pembro demonstrated a statistically significant and clinically meaningful improvement in DFS vs Obs for high-risk MIUC pts after radical surgery. The OS endpoint may have been impacted by pts on the Obs arm receiving a checkpoint inhibitor. Pembro was tolerable with no new safety signals. These results support adjuvant Pembro as a new therapeutic option for pts with MIUC with high risk for recurrence. Additional follow-up is ongoing for the final DFS/OS, PD-L1 subgroups, and ctDNA analyses. Clinical trial information: NCT03244384 .

Examining the effect of weight-related recruitment information on participant characteristics: A randomized field experiment.

Although 82% of American adults have a body mass index (BMI) of over 25, individuals with elevated BMI are considered difficult to recruit for studies. Effective participant identification and recruitment are crucial to minimize the likelihood of sampling bias. One understudied factor that could lead to sampling bias is the study information presented in recruitment materials. In the context of weight research, potential participants with higher weight may avoid studies that advertise weight-related procedures. Thus, this study experimentally manipulated the phrasing of weight-related information included in recruitment materials and examined its impact on participants' characteristics. Two visually similar flyers, either weight-salient or neutral, were randomly posted throughout a university campus to recruit participants (N=300) for a short survey, assessing their internalized weight bias, anticipated and experienced stigmatizing experiences, eating habits, and general demographic characteristics. Although the weight-salient (vs. neutral) flyer took 18.5days longer to recruit the target sample size, there were no between flyer differences in respondents' internalized weight bias, anticipated/experienced weight stigma, disordered eating behaviors, BMI, or perceived weight. Absolute levels of these variables, however, were low overall. Providing detailed information about study procedures allows participants to have more autonomy over their participation without differentially affecting participant characteristics.

Determining the Normal Glenoid Version in the Indian Population.

Background Glenoid version refers to the angle subtended by the glenoid with the scapula. On average, it is 0 ± 10 degrees with a slight propensity toward retroversion. Numerous factors such the dominance(handedness), gender, ethnicity, and pathology are known to affect version. Version has important consequences on the biomechanics of the shoulder joint and is altered in those with arthritis and shoulder joint instability. Aim Our study aimed to determine the normal range of glenoid version in the population. Further, we aim to assess the relationship between gender and version. Settings and Design We conducted a retrospective observational study in a tertiary referral hospital with a target sample size of 200 shoulders. Methods and Materials The computed tomography images were retrospectively reviewed to determine the scapular shape and the glenoid version angle. Statistical Analysis Statistical analysis was done using SPSS v.22 software with p -value less than 0.05 considered as significant. Results The mean age of the individuals in our study was 44 years. In our study, irrespective of gender, most individuals had some degree of anteversion and males had lower degree of anteversion. Previous studies have shown that most normal individuals usually have retroverted shoulder joints. The mean glenoid version was significantly lower in the right than in the left shoulder and males had significantly lower mean glenoid version than females in both shoulders. Most individuals in our study had a flat scapular spine. Conclusion This study shows that the Indian population may have a slight propensity toward anteversion and this has an important bearing on shoulder arthroplasty. Further, this study shows that significantly lower degrees of version are found on the right side and that the degree of version is significantly lower in males. Understanding the role of glenoid version in shoulder biomechanics will go a long way in the early identification of pathology, the preoperative planning of shoulder arthroplasty, and the operative restoration of a functional shoulder joint.

A randomized, placebo-controlled crossover trial to assess the influence of body weight on aspirin-triggered specialized pro-resolving mediators: Protocol for the DISCOVER Study.

Low-dose aspirin is ineffective for primary prevention of cardiovascular events in people with body weight greater than 70kg. While the prevalent explanation for this is reduced platelet cyclooxygenase-1 (COX-1) inhibition at higher body weights, supporting data are limited, thereby demanding further investigation of the reason(s) underlying this observation. We propose that aspirin-mediated cyclooxygenase-2 (COX-2) acetylation and the resulting synthesis of 15-epi-lipoxin A4, a specialized pro-resolving mediator, is suboptimal in higher weight individuals, which may contribute to the clinical trial findings. To test this hypothesis, we are conducting a double-blind, placebo-controlled, randomized, mechanistic crossover trial. Healthy men and women exhibiting a wide range of body weights take 81mg aspirin and 325mg aspirin for 3 weeks each, following 3-week placebo run-in and wash-out phases. Our target sample size is 90 subjects, with a minimum of 72 completing all visits estimated to be necessary to achieve power adequate to test our primary hypothesis. Our primary endpoint is the difference in change in plasma 15-epi-lipoxin A4 occurring with each dose of aspirin. Secondary endpoints include lipid mediator profiles, serum bioactive lipid profiles, and other endpoints involved in the resolution of vascular inflammation. Study enrollment began in November 2021 and is ongoing. The results of this study will improve our understanding of the mechanisms underlying aspirin's role(s) in the prevention of adverse cardiovascular outcomes. They may also lead to additional studies with the potential to inform dosing strategies for patients based on body weight.

Exploring trial publication and research waste in COVID-19 randomised trials of hydroxychloroquine, corticosteroids, and vitamin D: a meta-epidemiological cohort study

BackgroundThe global research response to the COVID-19 pandemic was impressive, but also led to an infodemic and considerable research waste. Registered, but unpublished trials added to this noise. We aimed to determine the proportion of registered randomised trials of common COVID-19 treatments that were published and to describe the characteristics of these trials to examine the association between trial characteristics, publication status and research waste.MethodsThis meta-epidemiological cohort study used a sample of randomised trials of corticosteroids, hydroxychloroquine or vitamin D as treatments for COVID-19, registered between 1 November 2019 and 31 December 2021 and available via the WHO ICTRP portal. We searched for the trials’ published results up to 20 October 2022. We extracted the trial characteristics, analysing with descriptive statistics. We performed univariate logistic regression to examine the association between trials’ characteristics and publication status, followed by multiple logistic regression using significant characteristics to assess the association between trial characteristics and publication status.ResultsWe identified 357 eligible trials on ICTRP. Of these, 107 (30%) had published or made their results available publicly by 20 October 2022, while 250 (70%) had not been published or shared their results publicly. Multiple logistic regression analysis showed that a larger target sample size was a significant positive predictor of publication with target sample sizes above 300 almost tripling the odds of publication (aOR: 2.75, 95% CI: 1.35 to 5.62).ConclusionsLess than one third of registered trials made their results public and our findings identified that many trialists had not updated their trial registry entry with the trial status, results or both. Failure to share trial results publicly is a disservice to patients, clinicians and policy makers and adds to research waste.

A prospective multicenter phase II trial of total neoadjuvant therapy for locally advanced rectal cancer in JAPAN: ENSEMBLE-1 study.

123 Background: The short- and long-term prognosis of total neoadjuvant therapy (TNT) for locally advanced rectal cancer (LARC) is elucidated in the world. We evaluated the feasibility and safety of TNT for patients with LARC in Japan. Methods: This prospective, multicenter, open-label, single-arm phase II trial was conducted at five institutions. The key eligibility criteria were age ≥20 years, LARC within 12 cm from the anal verge, and cT3-4N0M0 or TanyN+M0 at the time of diagnosis that enabled curative resection. Preoperative short-course radiation therapy (SCRT) 5 Gy × 5 days (total 25 Gy) + CAPOX (6 courses) followed by total mesorectum excision (TME) was the treatment protocol. Non-operative management (NOM) was allowed if clinical complete response (cCR) was obtained in the preoperative evaluation. The primary endpoint was the pathological complete response (pCR) rate. With a pCR rate threshold of 5%, an expected value of 28%, a one-sided significance level of 5%, and a power of at least 80%, the sample size required by the exact binomial distribution method would be ≥19 patients. Considering a few dropouts, ineligible cases, and patients in which resection was not performed, the target sample size was set to 27 patients. Results: Thirty patients (male, n=26; female, n=4; median age, 62.5 [44-74] years; cT [T2, n=1; T3, n=25; T4, n=4]; cN [N0, n=13; N1, n=13; N2, n=4]) were enrolled. The final analysis included 30 patients in total. The completion rates were 100% for SCRT and 83% for CAPOX. TME and NOM were performed in 20 and seven patients, respectively. pCR was observed in six patients (30% [95% CI 14.0%–50.8%]). The primary endpoint was met. pCR+cCR was observed in 13 (43.3%) patients at TME or restaging. There were no treatment-related deaths. Grade ≥3 (CTCAE ver. 5.0) adverse events (≥20%), including diarrhea (23.3%) and neutropenia (23.3%). The median follow-up period was 21.8 (10.9-29.6) months. Recurrences in three patients (10.0%) were observed. In NOM, regrowth (28.6%) in two patients occurred, of which one patient was performed TME and one patient is on chemotherapy. Conclusions: ENSEMBLE-1 demonstrated satisfactory pCR and cCR, and well-tolerated safety of TNT for patients with LARC in JAPAN. Further long-term prognosis observation is required. A phase III trial, ENSEMBLE (NCT05646511/jRCTs031220342) is currently ongoing in JAPAN. Clinical trial information: jRCT s051200113 .

Circulating tumor DNA analysis informing adjuvant chemotherapy in locally advanced rectal cancer: The randomized AGITG DYNAMIC-Rectal study.

12 Background: Adjuvant chemotherapy (CT) following neoadjuvant chemoradiation and surgery for locally advanced rectal cancer (LARC) is widely adopted, despite uncertain survival benefit. Circulating tumor DNA (ctDNA) detection after surgery has been shown to be a strong prognostic marker in localized colorectal cancer and potentially could inform adjuvant treatment decision making. Methods: AGITG DYNAMIC-Rectal is a multi-centre randomized controlled phase II trial. Eligible patients (pts) had LARC (cT3-4 and/or cN+) treated with neoadjuvant chemoradiation, total mesorectal excision, and were fit for adjuvant CT. Pts were randomly assigned 2:1 to ctDNA-guided management or standard management (clinician decision). A tumor-informed personalized ctDNA assay was used. For the ctDNA-guided group, a positive result at 4 and/or 7 weeks after surgery prompted 4 months of oxaliplatin-based or fluoropyrimidine CT; for ctDNA-negative patients, no chemotherapy if ypN0 or clinician’s choice if ypN+. The primary endpoint was adjuvant CT use. A key secondary endpoint was non-inferiority in RFS rate at 3 years. The target sample size of 408 would provide 80% power with 95% confidence to demonstrate non-inferiority between the two arms with a margin of at most 10%. Results: The study ceased recruitment prematurely due to COVID-19 and increasing adoption of total neoadjuvant therapy. 230 eligible pts were enrolled from Jul 2018 to Nov 2021, median follow-up was 37 months. In the 155 ctDNA-guided patients, ctDNA analysis was successful in 150 (97%) pts and 42 (28%) were ctDNA-positive. Fewer pts in the ctDNA-guided arm received adjuvant CT (71/155, 46%) compared to 58/75 (77%) pts receiving standard management (p < 0.001). Overall, an oxaliplatin-based doublet was administered in 43 (28%) and 19 (25%) of ctDNA-guided compared to standard management pts (P = 0.82). 3-year recurrence-free survival for ctDNA-guided and standard management was 76% and 82% respectively (difference 6%, 95% CI: -6% to 17%). Cumulative probability of distant and locoregional recurrence at 3 years for ctDNA-positive pts treated with CT were 36% and 11% respectively; for ctDNA-negative pts without adjuvant CT were 12% and 1%. Of the 15 ctDNA-negative pts who recurred, 12 (80%) were lung only, 1 (7%) peritoneal and lung, and 2 (13%) nodal only relapse. Conclusions: A ctDNA-guided approach to adjuvant therapy for LARC post neoadjuvant chemoradiation and surgery was associated with a reduced rate of CT administration. The small sample size precludes any conclusions to be drawn about the non-inferiority of ctDNA-guided vs standard management. The recurrence rate in treated ctDNA positive pts appears low when compared to untreated historical controls. Our data confirms a lower risk of recurrence in pts with undetectable post-op ctDNA, with a notable proportion of these being in the lung. Clinical trial information: ACTRN12617001560381 .

Are Web-Based Valuation Surveys for Preference-Based Measures as Reliable as Face-to-Face Surveys? TTO, DCE and DCE with Duration.

Valuation surveys of preference-based measures are typically conducted face-to-face or on web panels. In this survey, we considered whether face-to-face and online surveys were reliable using three tasks: composite time trade-off (cTTO), discrete choice experiment (DCE), and DCE with duration. Respondents (aged 20-69 years) for both face-to-face (N = 1000, target sample size) and web surveys were selected through quota sampling by sex and age from each panel of the general population in Japan. They were then allocated to one of the three tasks and divided into six groups (two survey modes × three tasks, N = 334 per group). For the cTTO, respondents were asked to rate ten health states described by the EQ-5D-5L. For the DCE and DCE with duration surveys, respondents were asked about 15 health-state pairs. For all participants, as in the second-stage survey, a similar process was repeated two weeks after the first survey. Reliability was evaluated by calculating the percentage of agreement and intraclass correlation coefficients. The cTTO scores of the face-to-face and web surveys were systematically different. Between the face-to-face and web surveys, the agreement of the TTO survey was not good. The intraclass correlation coefficient (ICC) was 0.37 for the face-to-face test-test and 0.59 for the web test-retest. Discrete choice experiment (DCE) and DCE with duration had similarly good agreement (more than 70%), regardless of face-to-face or web surveys. However, between the first and second surveys (test-retest) of DCE and DCE with duration, the agreement depends on whether the positions of the two cards (health states) are identical. If the face-to-face cTTO score is the gold standard, a web-based survey of cTTO is not recommended regardless of the ICC. If a DCE survey is performed, positioning effects should be considered.

Adjuvant medial versus entire supraclavicular lymph node irradiation in high-risk early breast cancer (SUCLANODE): a protocol for a multicenter, randomized, open-label, phase 3 trial

BackgroundSupraclavicular nodal (SCL) irradiation is commonly used for patients with high-risk breast cancer after breast surgery. The Radiation Therapy Oncology Group (RTOG) and European Society for Radiotherapy and Oncology (ESTRO) breast contouring atlases delineate the medial part of the SCL region, while excluding the posterolateral part. However, recent studies have found that a substantial proportion of SCL failures are located in the posterolateral SCL region, outside of the RTOG/ESTRO-defined SCL target volumes. Consequently, many radiation oncologists advocate for enlarging the SCL irradiation target volume to include both the medial and posterolateral SCL regions. Nevertheless, it remains uncertain whether adding the posterolateral SCL irradiation improves survival outcomes for high-risk breast cancer patients.MethodsThe SUCLANODE trial is an open-label, multicenter, randomized, phase 3 trial comparing the efficacy and adverse events of medial SCL irradiation (M-SCLI group) and medial plus posterolateral SCL irradiation (entire SCL irradiation, E-SCLI group) in high-risk breast cancer patients who underwent breast conserving-surgery or mastectomy. Patients with pathological N2-3b disease following initial surgery, or clinical stage III or pathological N1-3b if receiving neoadjuvant systemic therapy, are eligible and randomly assigned (1:1) to M-SCLI group and E-SCLI group. Stratification is by chemotherapy sequence (neoadjuvant vs. adjuvant), T stage (T3-4 vs. T1-2), N stage (N1-2 vs. N3), and ER status (positive vs. negative). Other radiation volumes are identical in the two arms, including breast/chest wall, undissected axillary lymph node, and internal mammary node. Advanced intensity modulated radiation therapy (IMRT), volumetric modulated arc therapy (VMAT), or tomotherapy techniques are recommended. Both hypofractionated and conventional fractionation schedules are permitted. The primary end point is invasive disease-free survival, and secondary end points included overall survival, SCL recurrence, local-regional recurrence, distance recurrence, safety outcome, and patient-reported outcomes. The target sample size is 1650 participants.DiscussionThe results of the SUCLANODE trial will provide high-level evidence regarding whether adding posterolateral SCL irradiation to medial SCL target volume provides survival benefit in patients with high-risk breast cancer.Trial registrationClinicalTrials.gov Identifier: NCT05059379. Registered 28 September 2021, https://www.clinicaltrials.gov/ct2/show/NCT05059379.

Mega-infrastructure development, tourism sustainability and quality of life assessment at world heritage sites: catering to COVID-19 challenges

PurposeMega-infrastructure development plans pave the way for policies to upgrade the infrastructure, environmental management and different aspects of locals’ well-being. These developmental dynamics can positively affect rural tourism including heritage sites destinations. The quality of life of local people can be linked to this positive developmental change through long-term and sustainable economic revitalization projects. In terms of this process, developing large-scale infrastructure and incorporating tourism sustainability can improve the quality of life-related to different dimensions that are critical to the community's well-being. Therefore, researchers have attempted to address this issue.Design/methodology/approachData were collected between September and October 2020. The study sample size was the residents of Zhabagly village, including Zhabagaly, Abaiyl and 115 Railway settlements. Moreover, the residents were older than 18 years. A systematic random sampling technique was utilised to reach the targeted sample size and the researchers received 243 responses from the locals. Structural equation modelling (SEM) was used for analysis.FindingsThe findings from the structural equation modelling suggest that sustainable tourism increases due to the positive effect of mega-infrastructure development and positively impacts the locals' quality of life. Notably, no direct effect of mega-infrastructure development on quality of life reveals the pivotal role of sustainable tourism. Therefore, during the COVID-19 period, the dimensions of sustainable tourism – economic, market, socio-cultural and environmental – played a role in securing the positive impact of mega-infrastructure development on the locals’ quality of life.Research limitations/implicationsThis research highlighted the fact that when infrastructure projects are implemented to their full potential, they will generate sustainable tourism activities, provide eco-adventure activities, relax, treat signatories and boost the economy of all stakeholders. The study used AMOS to test the hypotheses. Qualitative research methods, including interviews with citizens, government officials and tourism managers, require further study.Practical implicationsThe infrastructural development on a mega-scale means building an upscaling tourism ecosystem. This ecosystem is marked by the availability of drinking water, waste and energy management facilities that support the elevation of living material, community, health, safety and emotional well-being. It reflects the policy-level implications for future Belt and Road initiatives (BRIs). The tourism industry's resilience during COVID-19 has practical lessons for other industries.Originality/valueLarge-scale infrastructure construction must create favourable conditions for the rapid development of tourism. The availability of clean water, waste and energy management facilities contributes to the food production, social cohesion, physical and mental health and general well-being of the ecosystem. This is one of the few studies that used sustainable tourism as a mediator between the impact of large infrastructure projects and their impact on the quality of life of locals during the COVID-19 pandemic. Aksu-Zhabagly, a World Heritage Site in Kazakhstan, was the site of this field study.

The mid-term results of the Carotid Asymptomatic Stenosis (CARAS) observational study

IntroductionCarotid endarterectomy (CEA) in patients with asymptomatic carotid stenosis (ACAS) remains a subject of debate. Current recommendations are based on randomized trials conducted over 20 years ago and improvements in medical therapies may have reduced the risk of cerebral ischemic events (CIE). This study presents a mid-term analysis of results from an ongoing prospective observational study of ACAS patients to assess their CIE risk in a real-world setting. MethodsThis is a prospective observational cohort study of patients with ACAS >60 % (NASCET criteria) identified in a single duplex ultrasonography (DUS) vascular laboratory (trial registered: NCT04825080). Patients were not considered for CEA due to their short life expectancy (<3 year) or absence of signs of plaque vulnerability (ulceration, ipoechogenic core). Patient enrollment started in January 2019 and ended in March 2020 with a targeted sample size of 300 patients.A 5-year follow-up was scheduled. Clinical characteristics, risk factors, and medical therapies were documented, and, when necessary, the best medical therapy (BMT), involving antiplatelet agents, blood pressure control, and statins, was recommended during clinical visits. The primary endpoint was to asses CIEs (including strokes, transient ischemic attacks, amaurosis-fugax) ipsilateral to ACAS along with plaque progression rate and patients survival. Follow-up involved annual clinical visit and carotid DUS examination, complemented by telephone interviews at six-month intervals. ResultsThe study included 307 patients, with an average age of 80 ± 7 years, of whom 55 % were male. Contralateral stenosis exceeding 60 % was present in 61 (20 %) patients. Seventy-seven percent of patients were on BMT. At a mean follow-up of 41±9 months, 7 ispilateral strokes and 9 TIAs occurred, resulting in 14 CIEs (2 patients experienced both TIA and stroke). According to Kaplan–Meier analysis, the 4-year CIE rate was 6±2 %, with an annual CIE rate of 1.5 %. Fifty-eight (19 %) patients had a stenosis progression which was associated with a higher 4-year estimated CIE rate compared to patients with stable plaque (10.3 % vs 3.2 %, P=.01). Similarly, a contralateral carotid stenosis >60 % was associated with a higher 4-year estimated CIE rate: 11.7 % vs 2.9 %, P=.002. These factors were independently associated with high risk for CIE at the multivariate COX analysis: Hazard Ratio (HR): 3.2; 95 % Confidence Interval: 1.1-9.2 and HR: 3.6; 95 % CI: 1.2-10.5. ConclusionThe mid-term results of this prospective study suggest that the incidence of CIE in ACAS patients should not be underestimated, with plaque progression and contralateral stenosis serving as primary predictors of CIEs.

Population Prevalence, Pattern and Associated Factors for Retinal Diseases at High Altitude in Nepal.

Retinal diseases are common at high altitudes due to a cascade of changes caused by hypoxia. The aim of this study is to assess the population prevalence, pattern and associated factors of retinal disorders at high altitude in Nepal. A cross-sectional study was conducted at three selected high-altitude districts (over 2500 meters) of Nepal. Subjects were at least 40 years old, and the target sample size was 309. A detailed history was taken. Visual acuity, blood sugar, blood pressure, and oxygen saturation were measured. Anterior and posterior ocular evaluations were conducted by retina specialists using slit lamp and indirect ophthalmoscopy. A total of 338 participants were recruited, with nearly equal numbers from the three districts with mean age of 57.0 (S.D 11.1) years. Two-thirds (63.9%) were females; 38.2% were illiterate, and 46.7% were farmers. Average blood oxygen saturation was 87.2% (S.D 4.1%). Systemic hypertension and diabetes mellitus were found in 58% and 11%, respectively. Retinal diseases were found in 176 (52.5%), with bilateral involvement in 157 (46.9%). The major retinal diseases were hypertensive retinopathy (32.2%), high-altitude retinopathy (10.4%), age-related macular degeneration (AMD) (8.1%), branch vein occlusion (BRVO) (2.1%), and diabetic retinopathy (DR) (1.8%). The multivariate analysis showed significant association of retinal diseases with age and hypertension. Best corrected visual acuity better than 6/18 was present in 96.7%. Over half of the study participants had retinal diseases, with hypertensive retinopathy, AMD, and high-altitude retinopathy as the most common retinal problems. A significant association of retinal diseases was found with ageing, and hypertension. Access to eye care services and control of systemic hypertension along with patient education should be emphasized among people living at high-altitude.

Swiss cohort on Traumatic Childbirth and Health (SwiTCH): protocol for a prospective, population-based cohort study on parents’ mental health from pregnancy to one year postpartum

IntroductionApproximately 4%–5% of mothers develop childbirth-related post-traumatic stress disorder (CB-PTSD) and approximately 12.3% of mothers develop some CB-PTSD symptoms (CB-PTSS). To date, there is a dearth of studies on fathers...

Adalimumab vs placebo as add-on to Standard Therapy for autoimmune Uveitis: Tolerability, Effectiveness and cost-effectiveness—a protocol for a randomised controlled trial (ASTUTE trial)

IntroductionAdalimumab is an effective treatment for autoimmune non-infectious uveitis (ANIU), but it is currently only funded for a minority of patients with ANIU in the UK as it is restricted...