Sample Size Estimation Research Articles

Knowledge, Attitude, and Practice of Standard Infection Control Precautions Among Medical Students at King Khalid University Hospital.

Background Healthcare-associated infection (HAI) risk extends beyond patients to healthcare workers and medical students. However, many HAIs are preventable by adhering to standard infection control precautions (SICPs). This study assesses medical students' knowledge, attitudes, and practices regarding SICPs at the College of Medicine, King Saud University. Methodology A cross-sectional study was undertaken at the College of Medicine, King Saud University, Riyadh, Saudi Arabia, involving interns and medical students from years 1 to 5. The researchers constructed and validated an electronic questionnaire, which was used for data collection from December 2022 to June 2023. The estimated sample size was 371 students and interns, stratified by sex and educational level. The data collected included demographic characteristics, knowledge, attitudes, and practices regarding SICPs. Results Out of371 participants, approximately a quarter (25.1%) had a good knowledge score, 25.6% had a positive attitude, and 26.7% had good infection control practice. There was an association between good knowledge and male gender; being in clinical years 3, 4, 5, and interns; and attending infection control training (p < 0.05). A significant difference in practice was noted among females (p = 0.002). Conclusions This study showed low-to-moderate knowledge, attitude, and practice toward SICPs. These findings indicate a gap between the recommended guidelines and their implementation in healthcare settings, highlighting the necessity for integrating infection control education throughout the medical curriculum. Further research involving a larger sample from multiple institutions is warranted.

Systematic Review of Patient Preference Studies in Non-metastatic Breast Cancer Adjuvant Medication Therapy: Attribute Selection

Context: Breast cancer poses significant challenges due to its high incidence and prevalence, necessitating heightened attention. Understanding how patients prioritize different treatment options based on various attributes can assist healthcare decision-makers in maximizing patient utility. The discrete choice experiment, a conjoint method, facilitates preference elicitation by presenting different attributes and choices. This systematic review aims to identify key factors in patient preference research related to adjuvant treatment for early breast cancer characterized by hormone receptor-positive, HER2-negative status. Evidence Acquisition: PubMed, Embase, Web of Science, and Scopus were searched from 01.01.2000 to 31.03.2023. Original English articles reporting patient preferences in adjuvant breast cancer treatment were retrieved based on predefined inclusion and exclusion criteria. Included studies were examined through a narrative synthesis approach, with descriptive statistics employed for analysis. Results: Out of 1163 articles reviewed, four met the inclusion criteria and were conducted in the USA, Canada, and the Netherlands. Attributes extracted from all studies included alopecia, sensory neuropathy, motor neuropathy, myalgia/arthralgia, nausea, vomiting, fatigue, neutropenia, mucositis/stomatitis, hand-foot syndrome, diarrhea, prevention of breast cancer recurrence, osteoporosis, risk of endometrial cancer, joint and muscle pain, fluid retention, libido decrease, hot flashes, ECG monitoring, efficacy, treatment regimen, 5-year invasive disease-free survival (iDFS), dosing schedule, and treatment duration. The most frequently reported attributes were side effects, efficacy, and treatment regimen. Systematic review was commonly used to determine which attributes and levels to include. The minimum number of attributes identified per study was seven, and the maximum was 12. Sample sizes ranged from 102 to 300, with none of the studies mentioning the method of sample size estimation. Ordinary Least Squares, logistic regression, and hierarchical Bayes regression were the most frequent analysis methods. Conclusions: Side effects, 5-year iDFS, and treatment regimen are three attributes identified for conducting discrete choice experiment studies. Utilizing conjoint analysis to assess patient preferences for breast cancer treatment can aid in selecting optimal treatment regimens and improving patient adherence. Moreover, adhering to guidelines for developing experimental designs and conducting data analysis is essential for yielding robust results when employing preference elicitation methods.

Study on the efficacy and toxicity of pamiparib combined with tamoxifen in the treatment of patients with epithelial ovarian cancer with biochemical recurrence during first-line PARPi maintenance therapy.

TPS5621 Background: A high proportion of ovarian cancer patients tend to have elevated CA-125 1-6 months before imaging recurrence. The time between biochemical recurrence (i.e., only elevated CA-125 without imaging finding or clinical symptoms) to imaging recurrence can be considered a "window period", and if the “window period” can be extended, it may convert platinum-resistant relapsed patients to platinum-sensitive patients, and ultimately improving patient outcomes. The timing of treatment for the biochemical recurrent patients has been controversial. Tamoxifen, an anti-estrogenic drug, is considered an effective option for these patients. Pamiparib (BGB-290) is an investigational small molecule inhibitor of PARP1 and PARP2. According to OReO study(NCT03106987), the "PARPi after PARPi" strategy is effective in recurrent ovarian cancer patients previously treated with a PARP inhibitor. Therefore, we aim to further explore the use of PARP inhibitors in maintenance therapy for patients with ovarian cancer. Methods: This study (NCT05669768) will evaluate the efficacy and toxicity of pamiparib and tamoxifen in ovarian cancer patients with biochemical recurrence during first-line PARPi maintenance therapy. The included ovarian cancer patients are required to achieve No Evidence of Disease (NED) or demonstrated a response following platinum-based chemotherapy, with normalized CA-125 levels. First-line maintenance treatment with a PARP inhibitor is mandatory, with a minimum interval of ≥6 months to biochemical recurrence. The trial design is interventional, employing a Simon two-stage design to estimate sample size. The primary outcome of the study is the CA-125 response rate, which was assessed according to the GCIG criteria.1 The secondary outcome was Time to First Subsequent Therapy (TFST). Patients undergo regular assessments for tumor markers and imaging throughout treatment. If persistent elevation of tumor markers or the detection of recurrent lesions or distant metastases is observed, the patient is promptly removed from the study group. Standardized antitumor therapy is then initiated based on the patient's condition. The total planned enrollment is 46 participants, utilizing a single-group assignment and an open-label design. 1 of planned 12 patients for the first stage of accrual have been enrolled. Reference: 1. Rustin GJ, Vergote I, Eisenhauer E, et al. Definitions for response and progression in ovarian cancer clinical trials incorporating RECIST 1.1 and CA 125 agreed by the Gynecological Cancer Intergroup (GCIG). Int J Gynecol Cancer. 2011;21(2):419-423. Clinical trial information: NCT05669768 .

DOMINANT RISK FACTORS FOR THE INCIDENCE OF “ACUTE RESPIRATORY INFECTION” “ARI” IN TODDLERS

Background: Acute Respiratory Infection (ARI) is a contagious illness affecting diverse age groups, including toddlers, and is among the top ten reasons for Community Health Center visits. Purpose: This study aims to analyze the influence of dominant risk factors on the incidence of ARI in toddlers. Methods: This study used an observational, analytic-cross sectional approach, at Puskesmas Kampung Lalang, Medan, in 2023. The total population was 394 toddlers (aged 0-59 months). In the determination of the number of samples using the sample size estimation formula, 198 samples were obtained by purposive sampling. Data analysis used Chi-Square test and Multiple Logistic Regression Enter Methods, with a significance level of 95%. Results: The results showed that the variables of Vitamin A administration (OR = 0.27, 95% CI: 0.10-0.77) and immunization status (OR = 0.36, 95% CI: 0.14-0.93) were associated with a decreased risk of ARI in toddlers. In contrast, exclusive breastfeeding (OR = 2.35, 95% CI: 1.11-5.01) was associated with increased risk, while the physical environment of the house (OR = 2.92, 95% CI: 1.28-6.64) was associated with increased risk of ARI. Conclusion: Vitamin A administration and immunization reduce the risk of respiratory tract infection among under-fives at Puskesmas Kampung Lalang. Exclusive breastfeeding and home conditions increased the same risk. Improving these risk factors is essential to reduce the prevalence of childhood respiratory infections in the area.

Estimating statistical power for structural equation models in developmental cognitive science: A tutorial in R

Determining the compositional structure and dimensionality of psychological constructs lies at the heart of many research questions in developmental science. Structural equation modeling (SEM) provides a versatile framework for formalizing and estimating the relationships among multiple latent constructs. While the flexibility of SEM can accommodate many complex assumptions on the underlying structure of psychological constructs, it makes a priori estimation of statistical power and required sample size challenging. This difficulty is magnified when comparing non-nested SEMs, which prevents the use of traditional likelihood-ratio tests. Sample size estimates for SEM model fit comparisons typically rely on generic rules of thumb. Such heuristics can be misleading because statistical power in SEM depends on a variety of model properties. Here, we demonstrate a Monte Carlo simulation approach for estimating a priori statistical power for model selection when comparing non-nested models in an SEM framework. We provide a step-by-step guide to this approach based on an example from our memory development research in children.

Incidences of Pregnancy During Concurrent Use of Hormonal Contraceptives and Antiretroviral Therapy at Nakuru County Referral and Teaching Hospital in Kenya

With concerns on the efficacy and effectiveness of hormonal contraceptives and antiretroviral therapy in curbing incidences of unplanned pregnancies among women living with Human Immunodeficiency virus infection, a study to examine these concerns was carried out at Nakuru County Referral and Teaching Hospital (NCRTH). A cross-sectional retrospective study was carried out at the Comprehensive Care Centre (CCC) at NCRTH from March 2023 to April 2023 with a sample size of 226 participants however the estimated sample size using the Taro Yamane formula was 358. Data was collected using structured questionnaires with both open and close-ended questions and analyzed using the Statistical Package for Social Sciences (SPSS). Frequency tables, bar graphs, and percentages were used to present descriptive statistics. Chi-square was used to conduct inferential statistics, and P&lt;0.05 was considered significant. The majority (86.7%) of participants were on TLD (Tenofovir, Lamivudine, Dolutegravir). Most participants (37.17%) had used ART for 6-10 years. 79.65% of participants avoided pregnancy with concurrent hormonal contraceptives and ART, while 20.35% experienced pregnancies. 15.22% of pregnant participants also used other medications, especially anti-TBs, due to drug-drug interactions. Injectables were the most common contraceptive (41.3%) used by participants who had pregnancy incidences. A significant association was noted between the incidence of unplanned pregnancy and the use of combined oral contraceptives. Incidences of unplanned pregnancies were higher among those aged 30-34 (32.61%), married (73.91%), with secondary education (43.48%), self-employed (60.87%), and Protestant (73.91%). From this study, TLD was the most commonlyused antiretroviral, injectables were the most commonly used contraceptive, and the majority of the participants had used antiretrovirals for 6-10 years. Despite the concurrent use of hormonal contraceptives and antiretrovirals to avoid pregnancy incidences, 20.35% of the participants had unplanned pregnancy incidences. 15.22% of these participants who got pregnant were using other medications. Unplanned pregnancies were more common among certain demographic groups. From this study, data on pregnancy incidents during concurrent use of hormonal contraceptives and antiretroviral therapy is availed however limitations such as study design and time limit necessitatemore research. To reduce the risk of unplanned pregnancies and ensure the appropriate use of hormonal contraceptives, more support and counseling programs should be established for women using antiretrovirals.

Investigation of Sample Size Estimation for Measuring Quantitative Characteristics in DUS Testing of Shiitake Mushrooms

The sampling technique is commonly used in research investigations to more accurately estimate data with greater precision, at a lower cost and in less time. In plant DUS (distinctness, uniformity, and stability) testing, many quantitative characteristic data usually need to be obtained through individual measurements. However, there is currently no scientific method for determining the appropriate sampling size. The minimum number of testing samples for DUS testing was calculated based on the theory of sample size in descriptive studies and was validated through simple random sampling. The results show that the quantitative characteristics for the edible mushroom Shiitake (Lentinula edodes) in DUS testing were uniform. The calculated results show that 10 fruiting bodies for a single measurement were sufficient. Furthermore, the outcomes of the random sampling revealed that the mean of 10 samples did not significantly differ from the mean of all data. When the sample size exceeded 10, Cohen’s kappa statistic suggested that the conclusion of distinctness was very close to the near-perfect agreement. Reducing the number of samples did not affect the uniform assessment. This study suggests that the theory of sample size in descriptive studies could be applied to calculate the minimum sample size in DUS testing, and for Shiitake DUS testing, measuring 10 fruiting bodies was sufficient.

Randomized double-blind placebo-controlled trial of the effects of oral trehalose in spinocerebellar ataxia type 3: An interim analysis

IntroductionSpinocerebellar ataxia type 3 (SCA3) is a neurodegenerative disease characterized by increasingly worsening ataxia and non-ataxia features, negatively impacting patients’ quality of life. This study was designed to test formally evaluate whether oral trehalose was effective in SCA3 patients. MethodsIn this double-blind, randomized controlled trial, SCA3 patients received either 100 g oral trehalose or 30 g maltose to improve ataxia severity over six months. We also measured other clinical (non-ataxia), patient-reported (quality of life, motivations), and safety endpoints. An unscheduled interim analysis was conducted using two-way ANOVAs to analyze the interaction between time (baseline, 3-months, 6-months) and intervention (Trehalose vs. Placebo). ResultsFifteen participants (Trehalose = 7 vs. Placebo = 8) completed the study at the time of interim analysis. There was no interaction effect on the ataxia severity, and available data suggested an estimated sample size of 132 (66 per arm) SCA3 patients required to demonstrate changes in a 6-month trial. There were significant interaction effects for executive function (ƞ2 = 0.28–0.43). Safety data indicated that 100 g oral trehalose was well-tolerated. ConclusionWe performed an unplanned interim analysis due to a slow recruitment rate. The new estimated sample size was deemed unfeasible, leading to premature termination of the clinical trial. In this small, current sample of SCA3 patients, 100 g oral trehalose did not differentially impact on ataxia severity compared to placebo. Interestingly, our findings may suggest an improvement in executive function. Future efforts will require a large multi-country, multi-center study to investigate the potential effect of trehalose.

Investigating the Efficacy of a Community Support Network Rehabilitation Intervention for Improving Resiliency, Quality of Life, and Neurocognitive Function in Survivors of Intimate Partner Violence-Caused Brain Injury: Protocol for a Feasibility Study.

Globally, approximately 1 in 3 women experience intimate partner violence (IPV) in their lifetime. Brain injury (BI) is a common, yet often unrecognized, consequence of IPV. BIs caused by IPV tend to be mild, occur repetitively over the course of months or years, are remote in time, and result in chronic symptoms. Similar to BI from other causes, therapeutic treatment for women with IPV-caused BI (IPV-BI) is crucial to help resolve any physical or cognitive impairments, enhance the quality of life (QoL), and minimize longer-term neurodegeneration. This study aims to investigate the feasibility and efficacy of a community support network (CSN) rehabilitation intervention regarding its impact on resiliency, QoL, and neurocognitive function. In this pre- and postexperimental design, women (aged 18 to 50 years) who are survivors of IPV and IPV-BI will be recruited from various community organizations serving survivors of IPV. Exclusion criteria will include current pregnancy and any diagnosed neurological disorder known to affect cerebrovascular, neurocognitive, or sensorimotor function. A CSN rehabilitation intervention that includes aerobic exercise, cognitive training, mindfulness meditation, and counseling will be administered. A trauma-informed approach will be integrated into the design and implementation of the program. Furthermore, the program will include a participant navigator who will provide trauma- and violence-informed advocacy and systems navigation support to participants, in addition to facilitating a monthly peer support group. The intervention will be provided for 2.5 hours a day and 2 days a week for 3 months. Participants will complete psychological assessments and provide clinic-demographic information in the first assessment. In the second (before intervention), third (after intervention), and fourth (at follow-up) sessions, they will complete tests of resiliency, QoL, and neurocognition. The estimated sample size is 100. The objective of this study will be accomplished by quantitatively measuring resiliency, QoL, and neurocognition before and immediately after the intervention. A follow-up assessment will occur 3 months after the completion of the intervention to evaluate the maintenance of any improvements in function. One-way ANOVAs will be used to evaluate the intervention outcome across the testing times. Relationships among various variables will be explored using regression analysis. We anticipate that the CSN rehabilitation intervention will be effective in improving resiliency, QoL, and neurocognitive function in women who have experienced IPV-BI. Furthermore, we anticipate that this intervention will be feasible in terms of study recruitment, adherence, and retention. The CSN rehabilitation intervention will have a positive impact on resiliency, QoL, and neurocognitive functions in survivors of IPV-BI. Subsequently, a comparative study will be conducted by recruiting a control group receiving usual care. PRR1-10.2196/54605.

Concordance Rate of Pre-Operative Radiological Stage with Postoperative Pathological Stage in Colon Cancer

Aim: This study aimed to assess the concordance rate between pre-operative radiological staging using CT imaging and postoperative pathological staging in patients with colon cancer. Methodology: A prospective observational study was conducted at the Oncology Department of Jinnah Postgraduate Medical Center, Pakistan, with ethical committee approval between February 2023 to July 2023. Inclusion criteria involved patients diagnosed with colon adenocarcinoma aged &gt;18 receiving treatment at the center, while exclusion criteria comprised unconfirmed colon cancer, lack of consent, benign colonic polyps, metastatic cancer, chemotherapy recipients, and incomplete data. Sample size estimation yielded 227 patients. Recruitment used consecutive sampling, and data were collected using a predefined proforma. CT scans were performed, and T-stage was assessed by radiologists and pathologists. Histological analysis followed established guidelines, with final pathology serving as the gold standard. Results: The diagnostic accuracy of CT imaging was evaluated, with statistically significant concordance found between CT scans and histopathological diagnoses (p-value = 0.046). CT scans demonstrated a sensitivity of 57.14% for Stage I tumors and a specificity of 88.18% for Stage II-III tumors. The positive predictive value (PPV) was 13.3%, and the negative predictive value (NPV) was 98.48%, resulting in an overall accuracy of 87.22%. These findings suggest that CT imaging is valuable for identifying Stage II-III tumors, exhibiting good specificity and NPV, although sensitivity and PPV for Stage I tumors were comparatively lower. Chi-square testing confirmed the statistical significance of these results (p-value ≤ 0.05) Conclusion: This study highlights the utility of CT imaging in pre-operative staging of colon cancer, particularly for Stage II-III tumors, where it exhibits notable accuracy. However, improvements may be needed to enhance sensitivity and PPV for Stage I tumors. Keywords: Colon cancer, CT imaging, pathological staging, concordance rate, diagnostic accuracy.

Rising risks of hydroclimatic swings: A large ensemble study of dry and wet spell transitions in North America

Hydroclimatic swings between dry and wet spells are increasing globally, raising concerns due to their severe impacts on society, agriculture, infrastructure systems, and water resource management. These extremes and their projected changes are traditionally assessed in isolation, which can underestimate associated risks and future resilience and adaptation plans. This study investigates climate change projections of such lagged compound dry and wet spells across North America using a single model initial-condition large ensemble (SMILE). Three dry-wet spell indices are merged into an integrated indicator to provide a comprehensive perspective on changing risks. We apply an ensemble pooling approach using the Canadian Regional Climate Model version 4 Large Ensemble (CanRCM4-LE) to enhance sample size for index estimation. Results suggest that hydroclimatic swings across North America are expected to become more frequent and intensified in a warmer climate. Trends of spatial fraction and aggregation during transitions between dry and wet spells indicate future water resource management challenges. Hot spots for intensified transitions with higher frequency, such as Northern Central America, and the southern part of Eastern and Western North America, including Mexico and the state of California, overlap with larger spatial extent and higher aggregation during transitions. The seasonal analysis of spatial characteristics indicates winter may become wetter and summer drier at higher warming levels, potentially intensifying transitions between dry and wet extremes. Clustered hydroclimatic swings may lead to severe environmental, hydrological, and socio-economic consequences, necessitating appropriate mitigation and adaptation measures.

A Randomized Controlled Trial of Tenecteplase Versus Standard of Care for Minor Ischemic Stroke with Proven Occlusion (TEMPO-2): Rational and design of a multicenter, randomized open-label clinical trial.

Almost half of acute ischemic stroke patients present with mild symptoms and there are large practice variations in their treatment globally. Individuals with an intracranial occlusion who present with minor stroke are at an increased risk of early neurological deterioration and poor outcomes. Individual patient data meta-analysis in the subgroup of patients with minor deficits showed benefit of alteplase in improving outcomes; however, this benefit has not been seen with intravenous alteplase in published randomized trials. TEMPO-2 (A Randomized Controlled Trial of Tenecteplase Versus Standard of Care for Minor Ischemic Stroke With Proven Occlusion) is a prospective, open label with blinded outcome assessment, randomized controlled trial, designed to test the superiority of intravenous tenecteplase (0.25 mg/kg) over nonthrombolytic standard of care, with an estimated sample size of 1274 patients. Adult patients presenting with acute ischemic stroke with the National Institutes of Health Stroke Scale (NIHSS) ⩽ 5 and visible arterial occlusion or perfusion deficit within 12 h of onset are randomized to receive either tenecteplase (0.25 mg/kg) or standard of care. The primary outcome is return to baseline neurological functioning, measured by the modified Rankin scale (mRS) at 90 days. Safety outcomes include death and symptomatic hemorrhage (intra or extra-cranial). Other secondary outcomes include mRS 0-1, mRS 0-2, ordinal shift analysis of the mRS, partial, and full recanalization on follow-up computed tomography angiogram. Results of this trial will aid in determining whether there is benefit of using tenecteplase (0.25 mg/kg) in treating patients presenting with minor stroke who are at high risk of developing poor outcomes due to presence of an intracranial occlusion. Data will be available upon reasonable request.

Commentary: Customer-Perceived Innovation: Considerations for Financial Performance and Methodological Approaches

As firms increasingly uncover their activities to key stakeholders through various media, the perception of these activities is becoming more important for firm performance. Traditionally, access to industry-wide databases provides important metrics on customer perceptions of performance, such as customer satisfaction and brand equity. In addition, numerous studies have highlighted firms' innovation-related actions (e.g., R&amp;D spending and patent counts) as critical metrics linked to their financial performance. Perceived Firm Innovation (PFI) emerges as a relatively new and under-studied metric with the potential to impact a firm's financial success. Keiningham et al. are among the pioneers in this area. This commentary views their article as a vital initial step in understanding PFI’s impact. Considering that the service sector accounts for over 70 percent of the GDP in any developed country, service innovation is a broad phenomenon. Given the breadth of the area, we point to the challenge of capturing this phenomenon with a single metric like PFI. We also discuss crucial methodological considerations for future research, including estimation methods, sample size, and financial metrics.

Data from the Paper Entitled &amp;ldquo;Application of a Bayesian Approach for Exploring the Impact of Syllable Frequency in Handwritten Picture Naming&amp;rdquo;

The data presented here comes from the Perret and Solier (2022) study. 30 participants handwrote labels for 150 black-and-white drawings. The experiment was carried out using the DmDx program. Response times and production errors were the two behavioral reported measures. DmDx scripts and data are available on the OSF platform (DOI: https://doi.org/10.17605/OSF.IO/GAZF3). These data should be useful for pre-testing to explore new hypotheses, as well as for methodological elements (e.g., sample size estimation, estimation of a priori distributions for Bayesian analyses).

Study protocol: Early neurological deterioration in patients with minor stroke, frequency, predictors, and outcomes in Vietnam single-centre study.

Early neurological deterioration (END) is progressive neurological deterioration with an increase in NIHSS score of 2 points or more in the first 72 hours from the onset of acute ischemic stroke. END increases the risk of poor clinical outcomes at day 90 of ischemic stroke. We will study the frequency, predictors, and outcomes of patients with END in a case-control study at a comprehensive stroke centre in Vietnam. of the design is a descriptive observational study, longitudinal follow-up of patients with minor stroke hospitalized at the Stroke Center of Bach Mai Hospital from December 1, 2023, to December 1, 2024. Minor stroke patients characterized by NIHSS score ≤ 5 hospitalized within 24 hours of symptom onset will be recruited. The estimated END rate is about 30%, relative accuracy ε = 0.11, 95% reliability, expected 5% of patients lost data or follow-up, and an estimated sample size of 779 patients. This study will help determine the END rate in patients with minor stroke and related factors, thereby building a prognostic model for END. Our study determined the END rate in patients with minor stroke in Vietnam and also proposed risk factors for minor stroke management and treatment.

ACETABULAR FRACTURES IN OLDER PATIENTS INTERVENTION TRIAL (ACEFIT): A FEASIBILITY TRIPLE-ARM RANDOMIZED CONTROLLED STUDY

Current treatment options for displaced acetabular fractures in elderly patients include non-surgical management, surgical fixation and surgical fixation with simultaneous hip replacement, the so-called “fix-and-replace”™. There remains a paucity of evidence to guide surgeons in decision making for these difficult injuries. The aim of this study was to assess the feasibility of performing an appropriately powered RCT between treatment options for acetabular fractures in older patients.This was an NIHR funded feasibility triple-arm RCT with participation from 7 NHS MTCs. Patients older than 60 were recruited if they had an acetabular fracture deemed sufficiently displaced for the treating surgeon to consider surgical fixation. Randomisation was performed on a 1:1:1 basis. The three treatment arms were non-surgical management, surgical fixation and fix-and-replace. Feasibility was assessed by willingness of patients to participate and clinicians to recruit, drop out rate, estimates of standard deviation to inform the sample size calculation for the full trial and completion rates to inform design of a future definitive trial. EQ-5D was the primary outcome measure at 6 months, OHS and Disability Rating Index were secondary outcome measures.Of 117 eligible patients, 60 were randomised whilst 50 declined study participation. Nine patients did not receive their allocated intervention. Analysis was performed on an intention to treat basis. During the study period 4 patients withdrew before final review, 4 patients died and 1 was lost to follow-up. The estimated sample size for a full scale study was calculated to be 1474 participants for an EQ-5D MCID of 0.06 with a power of 0.8.This feasibility study suggests a full scale trial would require international collaboration. This study also has provided observed safety data regarding mortality and morbidity for the fix-and-replace procedure to aid surgeons in the decision-making process when considering treatment options.

Efficacy of acupuncture-related therapy in the treatment of primary dysmenorrhea: A network meta-analysis of randomized controlled trials

ObjectivesIn order to compare and rank the most effective acupuncture therapy for primary dysmenorrhea and provide evidence-based medical support for clinical treatment of this disease. MethodsA comprehensive search was conducted on China National Knowledge Infrastructure (CNKI), Wanfang Database, Information Chinese Journal Service Platform (VIP), China Biomedical Literature Service System (SinoMed), PubMed, Web of Science, Embase, and Cochrane Library databases from their inception to May 1, 2023. The Cochrane Collaboration Risk of Bias Tool was used to evaluate bias risk, and the GeMTC package of Stata 15.1 software and R 4.3.1 software was used to perform network Meta-analysis. Results70 studies were included, including 5772 patients with primary dysmenorrhea, involving 25 kinds of acupuncture techniques commonly used in clinic. The quality of the included literature was low, most of them did not mention the registration information of clinical trial centers, and the specific sample size estimation method was unclear. Some literature did not explain the specific random method, distribution concealment and blindness, so there was a certain publication bias and small sample effect. Results showed that for improving the clinical effective rate, the top three treatments were salt-separated moxibustion, massotherapy + acupoint patching, acupuncture + heat-sensitive moxibustion. In terms of reducing the visual analogue scale(VAS), the top three treatments were massotherapy + acupoint patching, acupuncture + acupoint patching and warm acupuncture. In terms of alleviating cox menstrual symptom scale (CMSS), the top three treatments were acupuncture + acupoint patching, acupoint patching and point embedding. In relieving TCM symptom score, the top three treatments were acupoint patching + heat-sensitive moxibustion, acupoint patching and moxibustion. ConclusionDifferent acupuncture therapies have more advantages than oral analgesics in improving the clinical effective rate, reducing VAS score, reducing CMSS score, and alleviating TCM symptom score. Among them, massage therapy + acupoint patching, acupuncture + acupoint patching and acupoint patching may be the best solutions for the treatment of primary dysmenorrhea. However, more large-sample, multi-center and high-quality randomized controlled trials are needed to demonstrate.

Perfusion outcomes with near-infrared indocyanine green imaging system in laparoscopic total mesorectal excision for mid-rectal or low-rectal cancer (POSTER): a study protocol

IntroductionAnastomotic leakage (AL) is defined as the failure of complete healing or disruption of the anastomosis subsequent to rectal cancer surgery, resulting in the extravasation of intestinal contents into the...

Diagnostic Accuracy of Abdominal Point of Care Ultrasound in Primary Care: Study Design and Protocol.

The aim of this study is to estimate the diagnostic accuracy of abdominal point of care ultrasound (POCUS) performed by family physicians (FPs) in primary care (PC), in comparison with the findings in the medical record (MR) at 12 months of follow-up. This study is conducted entirely in PC healthcare centers in Spain. Abdominal ultrasound scans performed by FPs (selected on the basis of their ultrasound knowledge and experience) are compared with the findings, or not, in the patient's MR after a 12-month follow-up period. The study will involve 100 FPs in Spain and an estimated sample size of 1334 patients who are to undergo abdominal POCUS at the indication of their physician. The results of the abdominal POCUS will be collected and compared with the findings of the MR. This comparison will be performed by another physician of the research team, different from their FP after one year of follow-up.The diagnostic accuracy of abdominal POCUS has been addressed in the hospital setting but not in PC. This lack of evidence can begin to be resolved with studies such as the one we present, designed for unselected populations such as those treated in PC and taking the patient's MR as the gold standard, which will allow us to make comparisons with the patient's clinical course.

Sample size estimation for AQP4-IgG seropositive optic neuritis: Retinal damage detection by optical coherence tomography.

We recruited four aquaporin-4 seropositive optic neuritis patients (five eyes) who received glucocorticoid treatment and underwent optical coherence tomography examination. Baseline medians of the macular ganglion cell layer plus inner plexiform layer (mGCIPL) thickness and volume for the eye of interest were 79.67 µm (73.664 ± 18.497 µm) and 0.58 mm3 (0.534 ± 0.134 mm3), respectively. At 2 months, the medians of the mGCIPL thickness and volume were 60.00 µm (51.576 ± 12.611 µm) and 0.44 mm3 (0.376 ± 0.091 mm3), respectively. At 6 months, the medians of the mGCIPL thickness and volume were 59.55 µm (46.288 ± 11.876 µm) and 0.44 mm3 (0.336 ± 0.084 mm3), respectively. Sample size estimate was achieved using two methods based on the mGCIPL thickness and volume data, with five effect sizes considered. The estimate based on the mGCIPL volume showed that 206 patients were needed at the 6-month follow-up; the power was 80% and effect size was 20%. In conclusion, this study detected retinal damage in aquaporin-4 seropositive optic neuritis patients by optical coherence tomography, and estimated the sample size for two-sample parallel designed clinical trials using two methods.