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Total knee arthroplasty (TKA) is one of the most common procedures in orthopaedics, but there is still debate over the optimal fixation method for long-term durability: cement versus cementless bone ingrowth. Recent improvements in implant materials and technology have offered the possibility of cementless TKA to change clinical practice with durable, stable biological fixation of the implants, improved operative efficiency, and optimal long-term results, particularly in younger and more active patients. This symposium evaluated the history of cementless TKA, the recent resurgence, and appropriate patient selection, as well as the historical and modern-generation outcomes of each implant (tibia, femur, and patella). Additionally, surgical technique pearls to assist in reliable, reproducible outcomes were detailed. Historically, cemented fixation has been the gold standard for TKA. However, cementless fixation is increasing in prevalence in the United States and globally, with equivalent or improved results demonstrated in appropriately selected patients. Cementless TKA provides durable biologic fixation and successful long-term results with improved operating room efficiency. Cementless TKA may be broadly utilized in appropriately selected patients, with intraoperative care taken to perform meticulous bone cuts to promote appropriate bony contact and biologic fixation. [ABSTRACT FROM AUTHOR]

There has been limited evaluation of surgeon-specific factors on outcomes after total shoulder arthroplasty (TSA). The goals of this study were (1) to determine the impact of surgeon procedural volume, career duration, practice type, and fellowship training on TSA outcomes at 2-year follow-up and (2) to evaluate the relative importance of surgeon variables in relation to patient variables in influencing outcomes. The PearlDiver Mariner database was queried to identify all surgeons who performed a minimum of 11 TSA procedures from 2010 to 2018. An Internet search of publicly available data was performed to determine the career duration, practice type, and fellowship training of each surgeon. Multivariate logistic regression models were built to determine the relationship between surgeon-specific variables and 2-year surgical complications and revisions and 90-day readmissions. Variable importance of patient-specific and surgeon-specific factors was determined by the Akaike information criterion increase of these models. A total of 2188 surgeons who performed 93,122 TSA procedures were identified in this database. Higher reverse TSA surgical volume was associated with fewer surgical complications and revisions, although such a relationship was not observed for anatomic TSA. Revision after anatomic TSA was more common among surgeons who were in their first 5 years of practice. There was a higher risk of surgical complication and readmission among academic surgeons, but this did not equate with a higher risk of revision. The impact of these surgeon-specific factors on outcomes was small in relation to patient-level variables, such as age, sex, and number of medical comorbidities. Surgeon procedural volume, career duration, and practice setting influence the surgical complication, revision, and readmission rates after TSA. The impact of surgeon factors was small relative to patient variables, highlighting the importance of patient selection in mitigating adverse outcomes. [ABSTRACT FROM AUTHOR]

The growing complexity of biopharmaceutical sponsored trials has adverse impacts on increased burdens on participants, clinical sites, and sponsors, including greater difficulty recruiting and retaining participants, difficulty engaging sites to participate in trials, excessive cost of trials, and increased cycle times. The schedule of assessments (SoAs) is the origin of and blueprint for complexity that is often generated by copying and pasting from previous SoAs. We developed an approach, termed Lean Design, for redesigning the assessments in SoAs that generate data, the 'Data SoA.' It starts with a simple "ground zero" SoA. Any addition is challenged using several principles of trial design. We employed a system, the Faro Trial Designer Tool, to quantify the impacts of changes in an SoA to provide real-time feedback to the team and sponsor. We applied the approach in workshops with teams for six clinical trials in various stages of design and implementation. The approach resulted in recommendation for substantial potential savings in participant and site staff time, costs, and complexity of the trials. Application of this approach to very early stages of protocol design has the potential to reduce the complexity of biopharmaceutical sponsored trials and its consequences. [ABSTRACT FROM AUTHOR]

Patient prioritization is a effective strategy to identify high risk patients for targeted Clinical Pharmacy Service (CPS) in hospital pharmacy. However, there is a paucity of patient prioritization tool to use in clinical practice. Describe the development, content validation and standardization of an adult patient prioritization tool for hospital CPS named, PrioFarClinH. The tool was developed using a stepwise design multi: Scoping Review to identify prioritization criteria/sub-criteria; Delphi technique to obtain consensus under the identified criteria/sub-criteria; Survey with pharmacists evaluating applicability of the criteria/sub-criteria obtained from Delphi; Definition of criteria/sub-criteria to be included in PrioFarClinH attribution of scores. Content validation was performed by a panel of experts evaluating relevance, feasibility, clarity and adequacy of the score. Content Validity Index (CVI) was calculated. Standardization occurred through a retrospective observational study carried out at 24 and 72 h and median of the patient's hospital stay. An intragroup norm was performed, determining percentile ranks of the instrument's total scores. Patients with a P90 score were classified with a high level of prioritization for CPS. PrioFarClinH is divided into three sections, with prioritization criteria for health issues; therapeutic classes; laboratory parameters. It comprises 51 criteria with specific scores with simple total calculation. None of the criteria presented CVI <0.78, maintaining the items from the initial version of PrioFarClinH. The scores were adjusted per suggestions from the panel of judges. Data were collected from 393 patients. The P90 percentile in the three hospitalization stages (24 h, 72 h, and median) was found, respectively, in the following scores: 18.0, 20.0, and 22.6. PrioFarClinH is a comprehensive tool to target and to prioritize adults patients most likely to benefit from CPS. Evidence for adequate content validity was provided. However, further validation of this tool is necessary to establish tool performance. [ABSTRACT FROM AUTHOR]

The aim of this study was to observe the trends in (1) utilization of meniscus allograft transplantation (MAT), (2) demographics and comorbidities of patients undergoing transplants and (3) reimbursements for this procedure between the years of 2010 and 2019. Using a national database, patients who underwent MAT were observed. Incidence of MAT, percentage of female patients, average age, and average Charlson comorbidity index (CCI) were analyzed between 2010 and 2019. Average reimbursement during the index and postoperative 90-day bundle period were also calculated from 2010 to 2019. Compound annual growth rate (CAGR) of change in incidence, demographic and reimbursement was calculated, and linear regressionwas conducted for each trends analysis. In total, 744 patients underwent a MAT between the years of 2010 and 2019. The incidence of MAT increased from 0.12 per 100,000 to 0.15 per 100,000 during this period but was not statistically significant (p=0.345). There was no significant difference in age (p=0.462) and gender (p=0.831) among the patients, but the average CCI significantly increased from 2010 to 2019 (CAGR: +15.30; p=0.001). The total reimbursement in the index (p=0.451) and 90-day bundle period (p=0.191) did not significantly change from 2010 to 2019. Although MAT has been shown to be a safe and reliable surgery for the treatment of meniscus deficient knees, the incidence of MAT as well as the population undergoing MAT has minimally increased from 2010 to 2019. Future studies should seek to identify why the utilization of this efficacious surgery has not increased. IV; Descriptive Epidemiology Study [ABSTRACT FROM AUTHOR]

Spasticity and dystonia are the commonest tonal abnormalities presenting in children and young people with Cerebral Palsy (CP). Hypertonia can cause difficulties in a wide variety of areas and impact on quality of life. Secondary changes in muscle and bone can result in further disability. Management of hypertonia is facilitated by appropriate identification of goals, muscles involved and type of hypertonia present. Stretches, exercise programmes, orthotic and equipment interventions are important mainstays in management of hypertonia. Identifying and addressing possible triggers can avert need for escalation of treatments. Medication choice and suitability of surgical interventions are influenced by other individual factors such as acceptability, route of administration and perceived benefits versus risks of intervention. Multidisciplinary working is an important cornerstone of hypertonia management. There are several medications available for treatment of hypertonia, although evidence is limited in their use in childhood. Where children have not tolerated or benefitted from medical treatments, surgical interventions may be appropriate. This short article is aimed at everyone involved in the care of children with hypertonia as a result of CP. It discusses how to select the right treatment for right patient and offers practical advice to clinicians. [ABSTRACT FROM AUTHOR]

African Americans experience higher incidence and prevalence of Alzheimer's disease (AD). Yet, they continue to be underrepresented in AD research, limiting the ability to generalize findings to the increasingly diverse US population. To reduce AD disparities, targeted efforts are needed to increase the representation of African Americans in AD research. This mini review identified evidence-based strategies that increased research participation among older African Americans. Four recruitment strategies emerged from eight published peer-reviewed studies that directly evaluated the effectiveness of strategies aimed at increasing the number of African American participants in Alzheimer's research. The strategies include community outreach and education, face-to-face discussions, remote access, and referral and partnership with local organizations. Across different locations, these strategies increased the number of African Americans enrolled into AD research, the number of people that signed up to donate their brains for AD research upon death, and the knowledge and perception of AD in the communities. Targeted efforts are effective in increasing AD research participation among older African Americans, especially when combined with approaches that emphasize transparency and mutual trust and involve the community as stakeholders in the research process. [ABSTRACT FROM AUTHOR]

Clinical trial conduct poses numerous challenges, many pertaining to patient recruitment. The primary objectives of this study were to update benchmarks on site activation and patient enrollment gathered in previous Tufts CSDD studies and examine current usage of recruitment and retention tactics. The data collection focused on site activation and patient enrollment metrics used for studies. Analyses were conducted comparing results from 2012, 2019 and 2023. The results indicate that actual enrollments exceeded planned enrollments for a majority of studies and timelines were shorter than expected. In addition, differences were found for enrollment achievement by global region and site type. Further investigation into studies conducted during a later time frame and post-pandemic could be compared with current benchmarks to examine differences. [ABSTRACT FROM AUTHOR]

Background: The drug development industry's focus on cancer-related treatments continues to rise, with narrow patient populations and complex procedures increasing the complexity of oncology protocols at an accelerated rate compared to non-oncology drugs. Tufts Center for the Study of Drug Development utilized data from a study investigating the impact of protocol amendments to compare how oncology clinical trials differ from non-oncology and identify opportunities to optimize performance in oncology clinical trials. Methods: Sixteen drug development industry companies contributed data from 950 protocols and 2,188 amendments to a study conducted in 2022 investigating protocol amendments. Analysis compared differences in amendment impact and causes between 249 oncology and 701 non-oncology protocols. Results: Compared to non-oncology, oncology protocols had a significantly higher prevalence (72.1% and 91.1%, respectively) and number (3.0 and 4.0, respectively) of protocol amendments. Oncology protocols with amendments had significantly lower participant completion rates compared to oncology protocols without amendments, while no significant differences were found among non-oncology. During the COVID-19 pandemic, the study found an increased number of substantial amendments, lower completion rates, and higher dropout rates among oncology protocols compared to before the pandemic. Conclusions: Efforts to prevent avoidable protocol amendments in the industry have not been effective in oncology, where increasingly complex designs are reflected in difficult to predict cycle times, barriers to recruitment and retention and an increase in protocol amendments. [ABSTRACT FROM AUTHOR]

Background: Recruiting participants with cardiovascular disease into research during the COVID-19 pandemic was challenging, particularly those at risk of health disparities. Objective: During the pandemic, 12 cohorts of older women with cardiovascular disease were recruited from cardiology clinics into a lifestyle intervention trial to prevent cognitive decline. Objectives were to (a) describe the results of modified recruitment/screening strategies to overcome pandemic-related challenges and (b) evaluate differences in age, race, and ethnicity between patients recruited/randomized, recruited/not randomized (entered recruitment but not randomized because of being ineligible or not interested), and not recruited (clinic patients who met preliminary criteria but did not enter recruitment). Methods: This was a cross-sectional descriptive analysis. In-person study strategies proposed before the COVID-19 pandemic were modified before study onset (September 2020). Women 65 years or older with cardiovascular disease were recruited from cardiology clinics by clinicians, posted flyers, and letters mailed to patients randomly selected from electronic health record data extractions. Patients were classified as recruited/randomized, recruited/not randomized, and not recruited. Results: Of 5719 patients potentially eligible, 1689 patients entered recruitment via referral (49.1%), posted flyers (0.5%), or mailed letters (50.3%), and 253 patients were successfully recruited/randomized. Recruited/randomized participants were, on average, 72.4 years old (range, 65–90 years old), non-Hispanic White (54.2%), non-Hispanic Black (38.3%), Hispanic/Latinx (1.6%), and other/not reported (5.1%). The recruited/randomized group was significantly younger with fewer patients of Hispanic/Latinx ethnicity compared with those not recruited. Conclusions: During the pandemic, all recruitment/screening goals were met using modified strategies. Differences in sociodemographic representation indicate a need for tailored strategies. [ABSTRACT FROM AUTHOR]

A dramatic increase in the number of vascular procedures performed in the office-based laboratory setting has been observed since 2008, when the Centers for Medicare and Medicaid Services increased reimbursement for procedures performed in the ambulatory setting. We sought to evaluate the appropriateness of arterial intervention in the office-based laboratory and patient selection. This systematic review was conducted with a search of Google Scholar and PubMed using the following search terms: office-based lab, outpatient, angioplasty, patient selection, arterial, and appropriateness. More than 500 publications were screened and 14 publications related to the topic were selected. The existing literature that examined patient selection for intervention in the outpatient setting, rates of complications after outpatient procedures, and short-term data on the safety and efficacy of these procedures is discussed. Gaps were identified in current knowledge about the long-term outcomes of peripheral arterial interventions performed in the office-based laboratory setting, as well as existing guidelines for the management of patients with peripheral arterial disease. [ABSTRACT FROM AUTHOR]

A novel technique for tracheoesophageal puncture (TEP) closure is described in which the sternohyoid muscles are rotated and interposed between the tracheal and esophageal walls. The results of this technique are reported, following CARE guidelines, and compared with those obtained using the sternocleidomastoid flap. A literature review on the techniques previously described for TEP closure in irradiated patients is presented. The novel technique was performed in six patients in whom the infrahyoid muscles were preserved during total laryngectomy. All received adjuvant radiotherapy. Successful closure was achieved in three cases; in one case a small leak was noted after initial closure and was successfully managed with simple sutures; and the other two failures occurred in patients with diabetes. The sternocleidomastoid flap was performed in five patients (only one with previous radiation) and success was achieved in two patients. In another patient a micro-fistular orifice appeared six months after the operation. The sternohyoid muscles pose a low morbidity alternative to be considered in surgical TEP closure. Patient selection is a key factor to surgical success, and this technique should be reserved for small to moderate size fistulas and in the absence of multiple impaired wound healing conditions. [ABSTRACT FROM AUTHOR]

Background: Cervical spondylotic myelopathy (CSM) is the most prevalent form of dysfunction in the cervical cord. For best results, CSM must be identified and treated quickly, before spinal cord injury develops. We aimed at determining the diagnostic value of quantitative and qualitative diffusion tensor imaging (DTI) indices in the assessment of CSM. Thirty patients were included in this prospective study with clinically suspected CSM of both sexes. This study aimed at determining the diagnostic value of quantitative and qualitative DTI indices in early assessment of CSM and subsequently early and proper management decision rendering better clinical outcome. Results: This prospective study included 30 patients: with clinically suspected CSM with a mean age of 51.88 ± 10.28 years. Patients with CSM were graded to 3 grades, mild (No. = 17), moderate (No. = 13) and severe (No. = 0) according to the modified Japanese orthopedic association (mJOA) grading system. Correlation test was performed between mJOA grades of severity with fractional anisotropy (FA), apparent diffusion coefficient (ADC) and T2 cord signal. We found a negative correlation between ADC and FA with Spearman's rho value of − 0.612 and "P value 0.000" (P value < 0.05), a positive correlation between FA with mJOA clinical score with Spearman's rho value of − 0.504 & "P value 0.036" (P value < 0.05) and a negative correlation between ADC and mJOA clinical score with Spearman's rho value of 0.385 and P value 0.005 (P value < 0.05), and no significant correlation was found between mJOA clinical score and T2 hyperintense signal with Spearman's rho value of − 0.304 and "P value 0.102" (P value < 0.05). Qualitative maps grading by 3D tractography images were done, and 18 patients in the study (60%) showed homogenous intact fiber tracts (grade I), 9 patients (30%) showed reduction or alteration of anisotropy or mixed colors intensity (grade II), and 3 patients (10%) showed fiber tract disruption or displaced cord (grade III). Three DTI parameters (other than FA and ADC) were measured, and two of them show significant difference between their measures in the stenotic and non-stenotic portions of the spinal cord—RA (P value = 0.00) and RD (P value = 0.00). Conclusions: We concluded that DTI is a crucial tool for early diagnosis and grading of CSM (cervical spondylosis myelopathy)—quantitatively and qualitatively—hence, it should be routinely integrated with conventional cervical spine MRI in case of clinically or radiologically suspected cervical cord compression, as the FA parameter together with the clinical assessment formulates the management plan decision for the CSM whether surgical or non-surgical and depicts the need for early surgical decision rendering better clinical outcome compared to that based on T2 hyperintense cord signal. [ABSTRACT FROM AUTHOR]

Outpatient total shoulder arthroplasty (TSA) presents a safe alternative to inpatient arthroplasty, while helping meet the rapidly rising volume of shoulder arthroplasty needs and minimizing health care costs. Identifying the correct patient for outpatient surgery is critical to maintaining the safety standards with TSA. This study sought to update an ambulatory surgery center (ASC) TSA patient-selection algorithm previously published by our institution. A retrospective chart review of TSAs was performed in an ASC at a single institution to collect patient demographics, perioperative risk factors, and postoperative outcomes with regard to reoperations, hospital admissions, and complications. The existing ASC algorithm for outpatient TSA was altered based on collected perioperative information, review of pertinent literature, and anesthesiology recommendations. A total of 319 TSAs were performed in an ASC in 298 patients over 7 years. Medically related complications occurred in 3 patients (0.9%) within 90 days of surgery, 2 of whom required hospital admission (0.6%) for acute kidney injury and pulmonary embolus. There were no instances of major cardiac events. Orthopedic-related complications occurred in 11 patients (3.4%), with hematoma development requiring evacuation and instability requiring revision being the most common causes. There was a low rate of perioperative complications and hospital admissions, confirming the safety of TSAs in an ASC setting. Based on prior literature and the population included, a pre-existing patient-selection algorithm was updated to better reflect increased comfort, knowledge, and data regarding safe patient selection for TSA in an ASC. [ABSTRACT FROM AUTHOR]

Objectives: This study aimed to analyze trends in the timely diagnosis of malaria cases over the past 10 years in relation to the utilization of different types of healthcare facilities. Methods: The study included 3,697 confirmed and suspected cases of malaria reported between January 1, 2013, and December 31, 2022, in the national integrative disease and healthcare management system. Some cases lacking a case report or with information missing from the case report were excluded from the analysis. A generalized linear model with a Poisson distribution was constructed to estimate risk ratios and 95% confidence intervals adjusted for other variables, such as distance. Results: When cases involving diagnosis >5 days after symptom onset in confirmed patients (5DD) were examined according to the type of healthcare facility, the risk ratio of 5DD cases was found to be higher for tertiary hospitals than for public health facilities. Specifically, the risk ratio was higher when the diagnosis was established at a tertiary hospital, even after a participant had visited primary or secondary hospitals. In an analysis adjusted for the distance to each participant's healthcare facility, the results did not differ substantially from the results of the crude analysis. Conclusion: It is imperative to improve the diagnostic capabilities of public facilities and raise awareness of malaria at primary healthcare facilities for effective prevention and control. [ABSTRACT FROM AUTHOR]

To investigate whether the distance between the two retromolar trigones (RMTs) with the distance between the two posterior plicas (PPs) affects obstructive sleep apnea syndrome (OSAS) and to determine a physical examination method that can be used in the selection of patients to be referred to polysomnography (PSG). The study included 86 OSAS patients and 29 healthy controls. RMTs and PPs were measured using a caliper-like device. The values obtained from these measurements were evaluated in both groups. The PPs were narrower, and the RMTs-PPs, RMTs-PPs/RMTs, and RMTs/PPs values were greater in the OSAS group (p <.05) compared to the control group. The cut-off values were 0.612 for RMTs-PPs/RMTs and 2.589 for RMTs/PPs. The specificity of these values for OSAS was 97%, and sensitivity was 57% and 58%, respectively. The presented method may play a role in preventing unnecessary PSG among patients with suspected OSAS. [ABSTRACT FROM AUTHOR]

Background: African American (AA) men bear a disproportionate burden of cardiovascular disease and stroke but are often underrepresented in research. Objective: This article describes the development and evaluation of a recruitment plan to reach young AA men for the Stroke Counseling for Risk Reduction in Men project. Methods: The plan was developed from researchers' previous experiences and a literature review, and used to recruit AA men, ages 20 to 35 years, for focus groups about stroke and Stroke Counseling for Risk Reduction. Results: Screening survey respondents (N = 81) were reached mostly by word of mouth (42%) and social media (28%). Focus group participants (N = 32) recommended appropriate incentives and social media to recruit young AA men for research. They also suggested learning about the study from a friend, colleague, or study participant could motivate participation. Conclusion: The plan was successful in reaching and enrolling an adequate sample. Findings and recommendations highlight the importance of social networks and trusted sources. [ABSTRACT FROM AUTHOR]

This article discusses the role of translation and its impact on the success of patient education materials, particularly in the context of patient recruitment and retention for clinical trials. We examine how translation and localisation help foster trust, ensure safety, and increase efficiency, improving recruitment, retention, and regulatory compliance in trials which are becoming increasingly diverse. We also discuss inherent challenges and considerations and look into the future. [ABSTRACT FROM AUTHOR]

Importance: Some people experience persistent symptoms after a concussion that greatly affect occupational performance. Objective: To evaluate the feasibility and preliminary effect of metacognitive strategy training in a sample of adults with postconcussive symptoms. Design: Single-group, prospective design. Setting: University research laboratory. Participants: Adults with persistent concussive symptoms affecting function (N = 14). Intervention: Ten 45-min sessions of a metacognitive strategy training intervention, Cognitive Orientation to daily Occupational Performance (CO-OP). Outcomes and Measures: Assessed feasibility outcomes included recruitment, retention, and adherence rates, and intervention acceptability was evaluated with the Client Satisfaction Questionnaire–8. The preliminary effect was measured on occupational performance (Canadian Occupational Performance Measure), concussive symptoms (Neurobehavioral Symptom Inventory), sleep (Pittsburgh Sleep Quality Inventory), vision (College of Optometrists in Vision Development–Quality of Life Outcomes Assessment), and cognition outcomes (Dysexecutive Questionnaire, Weekly Calendar Planning Activity, and National Institutes of Health Toolbox Cognition Battery). Results: Acceptable recruitment (32%), retention (93%), and adherence rates (100%) were observed, along with a high level of acceptability to participants. Large intervention effects were present for occupational performance, general concussive symptoms, and cognitive functioning. Conclusions and Relevance: Findings suggest that the CO-OP is feasible to administer for adults with postconcussive symptoms and perceived as suitable for the needs of this population. Feasibility findings, coupled with improvements in occupational performance outcomes, provide the foundation for a future larger scale trial. Plain-Language Summary: The Cognitive Orientation to daily Occupational Performance intervention is practical to use to address the functional impact of persistent concussive symptoms in adults. Further research is needed to evaluate the efficacy of the CO-OP intervention with this population. The Cognitive Orientation to daily Occupational Performance intervention is practical to use to address the functional impact of persistent concussive symptoms in adults. [ABSTRACT FROM AUTHOR]

• The prevalence of incidentally discovered gallbladder cancer (GBC) is approximately 0.5% in the West, justifying, for many, systematic histological examination (HE) of the resected specimen. • Some authors advocate a policy of selective HE based on macroscopic examination of the opened gallbladder by the surgeon in the operating room. HE is then requested only in case of doubt or suspicion of incidentally-discovered cancer. • This selective attitude is not indicated in the presence of pre-operative factors (advanced age, female gender, acute cholecystitis, gallbladder polyp, calcified gallbladder) or intra-operative factors suggesting the existence of GBC. • According to recent data, the reliability of macroscopic examination is 100%. Cancers not detected by macroscopic examination in the operating room are early-stage pTis or pT1a cancers curable by simple cholecystectomy. • A pre-requisite for this policy is the rigorous macroscopic examination (manual and visual) of the gallbladder wall and mucosa by the surgeon before deciding to send the specimen for HE. The quality of the macroscopic examination is the only guarantee of its reliability. • This review could serve as a working basis for clinical practice recommendations. The histological examination (HE) of all cholecystectomy specimens removed for cholelithiasis is a widespread practice to rule out unrecognized gallbladder cancer. (GBC). But this dogmatic practice has been called into question by recent published data. The aim of this literature review was to answer two questions: (1) can HE be omitted in specific cases; (2) under what conditions is a selective strategy indicated? A review of the literature was carried out that included selected multicenter studies, registry studies, or meta-analyses. A reliable technique for the surgeon's macroscopic examination of the specimen would allow the selection of dubious cases for HE. The cost-effectiveness of selective HE was discussed. The PICO methodology (population, intervention, comparator, outcome) was used in the selection of articles that compared routine and selective histological examination. If cases from countries with a high prevalence of gallbladder cancer are excluded and in the absence of high-risk situations (advanced age, female gender, calcified or porcelain gallbladder, acute cholecystitis, polyps, abnormalities noted intra-operatively), the macroscopic examination of the gallbladder in the operating room has a reliability approaching 100% in the majority of published studies. This would make it possible to omit systematic HE without compromising the diagnosis and prognosis of patients with unsuspected GBC and with a very favorable cost-effectiveness ratio. Through a selection of patients at very low risk of incidentally-discovered cancer and a routine macroscopic examination of the opened gallbladder, the strategy of selective HE could prove useful in both clinical and economic terms. [ABSTRACT FROM AUTHOR]

Background: Health care inequity includes the lack of adequate representation of various populations in clinical trials. Government, academic and industry organizations have highlighted these issues and committed to actions to improve. In order to assess the current status and future success of these initiatives a quantitative objective measure to assess the state of clinical trial diversity is needed. Methods: FDA review documents for all novel drug approvals from January 2022 through March 2023 were assessed using a scorecard that considers diversity across different demographic subgroups including age (≥ 65 years old), sex (female), race (Black and Asian) and ethnicity (Hispanic/Latino). The scorecard assigns each drug a letter grade, between A and F, for each subgroup (and overall) based on (1) the percent of each sub-population included in the trials and grades relative to the percent of the US population per the 2020 Census, (2) the number of participants from each subpopulation that received the novel new drug in the trials, (3) the incidence or prevalence of the disease/condition in each of the sub-populations. Results: The FDA approved 49 novel new drugs for 50 indications (one drug was simultaneously approved for two indications). There was good representation of elderly and females with only two drugs receiving a D grade in either of these sub-populations. In contrast, Black (5 F grades) and Hispanic (4 F grades) representation was often inadequate. There were 10 drugs (20.0%) where there were no Black participants receiving the novel new drug and 16 (32.0%) approvals where there were 1–9 Black participants receiving the novel drug. In the Hispanic/Latino population there were 4 (8.0%) approvals with no Hispanic participants receiving the novel drug and 15 (30.0%) approvals where there were 1–9 Hispanic participants receiving the drug. Conclusions: This scorecard provides an objective quantitative approach to assess the current state of diversity in clinical trials supporting new drug approvals. Substantial improvement in racial and ethnic representation is needed. Meaningful change will require actions and cooperation among all stakeholders to address this multifaceted issue and will take commitment, perseverance, and appropriate incentives. [ABSTRACT FROM AUTHOR]

Given progressive developments and demands on clinical trials, accurate enrollment timeline forecasting is increasingly crucial for both strategic decision-making and trial execution excellence. Naïve approach assumes flat rates on enrollment using average of historical data, while traditional statistical approach applies simple Poisson-Gamma model using time-invariant rates for site activation and subject recruitment. Both of them are lack of non-trivial factors such as time and location. We propose a novel two-segment statistical approach based on Quasi-Poisson regression for subject accrual rate and Poisson process for subject enrollment and site activation. The input study-level data are publicly accessible and it can be integrated with historical study data from user's organization to prospectively predict enrollment timeline. The new framework is neat and accurate compared to preceding works. We validate the performance of our proposed enrollment model and compare the results with other frameworks on 7 curated studies. [ABSTRACT FROM AUTHOR]

Excessive placebo response rates have long been a major challenge for central nervous system (CNS) drug discovery. As CNS trials progressively shift toward digitalization, decentralization, and novel remote assessment approaches, questions are emerging about whether innovative technologies can help mitigate the placebo response. This article begins with a conceptual framework for understanding placebo response. We then critically evaluate the potential of a range of innovative technologies and associated research designs that might help mitigate the placebo response and enhance detection of treatment signals. These include technologies developed to directly address placebo response; technology-based approaches focused on recruitment, retention, and data collection with potential relevance to placebo response; and novel remote digital phenotyping technologies. Finally, we describe key scientific and regulatory considerations when evaluating and selecting innovative strategies to mitigate placebo response. While a range of technological innovations shows potential for helping to address the placebo response in CNS trials, much work remains to carefully evaluate their risks and benefits. [ABSTRACT FROM AUTHOR]

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Eligibility criteria are essential in cancer clinical trials to maximize patients' safety and to select a population likely to benefit. Criteria generally include laboratory values that estimate organ function, performance status (PS), and concurrent diagnoses or medications. However, overly stringent criteria can impede trial enrollment, exclude underrepresented groups, and limit the generalizability of results. In addition to unavailability of clinical trials, ineligibility for existing trials is a major barrier to participation. The American Society of Clinical Oncology and Friends of Cancer Research have developed consensus recommendations for eligibility criteria, and the National Cancer Institute's Cancer Therapy Evaluation Program has updated protocol templates to meet the need for modernized eligibility criteria. [ABSTRACT FROM AUTHOR]

The article decenters the concept of trust and discusses ways find and engage women with criminal legal system involvement (CLSI) in the community using a participant-centered approach founded in harm reduction principles. It describes CLSI-women as hard to reach research subjects. It explains the importance of centering the participant by showing up with empathy and humanity, as well as an equity-centered approach to transformative research with marginalized communities.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has distorted the health-care system at a global level. Organ donation being a life-saving procedure, it continued even in the COVID era, although at a slow pace. Irrespective of the increase in renal transplants in the later era of COVID-19, the scarcity of literature for a review article in this context resulted in the genesis of this study. A retrospective data collection was conducted over various databases in the English language. The databases were thoroughly searched with keywords COVID-19, Coronavirus, SARS-CoV-2, and renal transplant. The data from various sources including original articles comprising single- and multicenter studies were collected, analyzed, and compiled over various parameters. The data were framed as mean, median, percentage, and standard deviation. We analyzed 10 single-centered studies and 4 multicenter studies conducting renal transplantation during the COVID era. The mean age of donor and recipient in the analysis was 47.6 ± 6.01 years and 47.8 ± 6.65 years, respectively. Two transplant centers used deceased renal donors only and one centre was doing transplant only on live donors and the remaining of the centres were taking both live and deceased donors. We observed that four studies had no COVID-positive recipient in their follow-up and the maximum COVID-positivity rate was 50%. Among reviewed 14 studies, 8 studies had no mortality in recipients who were COVID positive and the maximum mortality was 54%. To reduce morbidity and mortality, strict criteria for COVID-19 workup in donor and recipient patients should be followed. The type of donor has no direct relation to the risk of acquiring COVID-19 infection. The vaccination program has been accepted worldwide to reduce the severity of COVID-19 infection even in transplant patients. [ABSTRACT FROM AUTHOR]

The recent Society for Maternal-Fetal Medicine Consult Series #65 provides a comprehensive review of transabdominal cerclage. The current article condenses the Consult recommendations regarding patient selection, counseling, and management into 2 simple one-page checklists, one for the primary obstetrical provider and the other for the maternal-fetal medicine consultant or cerclage provider. Moreover, we provide sample templates for medical record notes to document preprocedure counseling and informed consent. [ABSTRACT FROM AUTHOR]

Cardiac physiologic pacing (CPP), encompassing cardiac resynchronization therapy (CRT) and conduction system pacing (CSP), has emerged as a pacing therapy strategy that may mitigate or prevent the development of heart failure (HF) in patients with ventricular dyssynchrony or pacing‐induced cardiomyopathy. This clinical practice guideline is intended to provide guidance on indications for CRT for HF therapy and CPP in patients with pacemaker indications or HF, patient selection, pre‐procedure evaluation and preparation, implant procedure management, follow‐up evaluation and optimization of CPP response, and use in pediatric populations. Gaps in knowledge, pointing to new directions for future research, are also identified. [ABSTRACT FROM AUTHOR]

Activation of the triggering receptor expressed on myeloid cells-1 (TREM-1) pathway is associated with septic shock outcomes. Data suggest that modulation of this pathway in patients with activated TREM-1 might improve survival. Soluble TREM-1 (sTREM-1), a potential mechanism-based biomarker, might facilitate enrichment of patient selection in clinical trials of nangibotide, a TREM-1 modulator. In this phase 2b trial, we aimed to confirm the hypothesis that TREM1 inhibition might improve outcomes in patients with septic shock. This double-blind, randomised, placebo-controlled, phase 2b trial assessed the efficacy and safety of two different doses of nangibotide compared with placebo, and aimed to identify the optimum treatment population, in patients across 42 hospitals with medical, surgical, or mixed intensive care units (ICUs) in seven countries. Non-COVID-19 patients (18–85 years) meeting the standard definition of septic shock, with documented or suspected infection (lung, abdominal, or urinary [in patients ≥65 years]), were eligible within 24 h of vasopressor initiation for the treatment of septic shock. Patients were randomly assigned in a 1:1:1 ratio to intravenous nangibotide 0·3 mg/kg per h (low-dose group), nangibotide 1·0 mg/kg per h (high-dose group), or matched placebo, using a computer-generated block randomisation scheme (block size 3). Patients and investigators were masked to treatment allocation. Patients were grouped according to sTREM-1 concentrations at baseline (established from sepsis observational studies and from phase 2a change to data) into high sTREM-1 (≥ 400 pg/mL). The primary outcome was the mean difference in total Sequential Organ Failure Assessment (SOFA) score from baseline to day 5 in the low-dose and high-dose groups compared with placebo, measured in the predefined high sTREM-1 (≥ 400 pg/mL) population and in the overall modified intention-to-treat population. Secondary endpoints included all-cause 28-day mortality, safety, pharmacokinetics, and evaluation of the relationship between TREM-1 activation and treatment response. This study is registered with EudraCT, 2018-004827-36, and Clinicaltrials.gov , NCT04055909. Between Nov 14, 2019, and April 11, 2022, of 402 patients screened, 355 were included in the main analysis (116 in the placebo group, 118 in the low-dose group, and 121 in the high-dose group). In the preliminary high sTREM-1 population (total 253 [71%] of 355; placebo 75 [65%] of 116; low-dose 90 [76%] of 118; high-dose 88 [73%] of 121), the mean difference in SOFA score from baseline to day 5 was 0·21 (95% CI −1·45 to 1·87, p=0·80) in the low-dose group and 1·39 (−0·28 to 3·06, p=0·104) in the high-dose group versus placebo. In the overall population, the difference in SOFA score from baseline to day 5 between the placebo group and low-dose group was 0·20 (−1·09 to 1·50; p=0·76),and between the placebo group and the high-dose group was 1·06 (−0·23 to 2·35, p=0·108). In the predefined high sTREM-1 cutoff population, 23 (31%) patients in the placebo group, 35 (39%) in the low-dose group, and 25 (28%) in the high-dose group had died by day 28. In the overall population, 29 (25%) patients in the placebo, 38 (32%) in the low-dose, and 30 (25%) in the high-dose group had died by day 28. The number of treatment-emergent adverse events (111 [96%] patients in the placebo group, 113 [96%] in the low-dose group, and 115 [95%] in the high-dose group) and serious treatment-emergent adverse events (28 [24%], 26 [22%], and 31 [26%]) was similar between all three groups. High-dose nangibotide led to a clinically relevant improvement in SOFA score (of two points or more) from baseline to day 5 over placebo in those with higher cutoff concentrations (≥532 pg/mL) of sTREM-1 at baseline. Low dose nangibotide displayed a similar pattern with lower magnitude of effect across all cutoff values. This trial did not achieve the primary outcome of improvement in SOFA score at the predefined sTREM-1 value. Future studies are needed to confirm the benefit of nangibotide at higher concentrations of TREM-1 activation. Inotrem. [ABSTRACT FROM AUTHOR]

Background: Significant proportion of haemodialysis (HD) patients fails to comply with their prescribed medication regimens, leading to poor health outcomes and survival rates. This highlights the need for interventions that improve medication adherence thereby leading to improved patient outcomes. Objectives: To evaluate the impact of motivational interviewing, a skilful clinical method to improve medication adherence among HD patients. Methods: A pre-post study was conducted prospectively among 63 HD patients at multicentre dialysis units. The recruited patients received three sessions of MI which helps in addressing patient beliefs around medication and overcome barriers for nonadherence. General medication adherence scale (GMAS) was used to evaluate the medication adherence among enrolled patients. An independent t-test was used to analyze the impact of MI in improving adherence among HD patients. In this study, the level of significance was 0.05. Results: A total of 63 patients (27 males and 36 females; mean age 48.5±13.9 years) were included in the study. While the mean of dialysis duration and number of medications was 7.7±6.0 years and 8.1±2.2 respectively. Paired t-test showed a significant increase in medication adherence score from a baseline for nonadherence domain of patient's attitude and nonadherence domain of additional illness and pill overload at the end of the study (p<0.05). However, the non-adherence domain of financial constraints, was not statistically significant, p=0.507. Motivational interviewing was effective in increasing intrinsic positive attitude by resolving their ambivalence thus improving the adherence towards medication. Conclusion: This study emphasized that MI conducted by pharmacist effectively improves HD patients' medication adherence. Healthcare professionals ought to employ this strategy in order to assist HD patients in better taking their medications. [ABSTRACT FROM AUTHOR]

Introduction: With advances in monitoring, anesthesia, and minimally invasive techniques, same-day surgeries are expected to rise significantly in the coming years. In this group, patients undergo diagnostic and therapeutic procedures and are sent home on the same day. This poses a great responsibility on the doctors involved and the hospital services, in ensuring the absence of delays, unanticipated admissions, and unexpected adverse events. Patient selection criteria are being used effectively by various centers across the world to prevent elective case cancellation and unplanned hospital admission and identify high-risk cases for major complications including morbidity and mortality. In recent year patient selection criteria, based on the latest guidelines, are being used to identify the risk factors and channel patients for ambulatory, day-care, and inpatient categories. Aims and Objectives: This article purposes a proper patient selection process for the improvement of quality and safety in patients undergoing day-care and office-based procedures. The patient selection criteria, if understood by all the team players, is instrumental in providing clinical guidance and appropriate patient triaging for caring for an ever-increasing, large volume of same-day surgical population. As the volume and complexity of the patient population grow, it is important to revise the patient selection criteria from time to time. Conclusion: Patient selection criteria have to be developed and modified by bodies and institutions to suit local circumstances to channel patients for ambulatory, day-care, and inpatient categories. Processes, administrative, clinical, and technical standards must be in-built into place and the pathway need to be well understood by all the team players in an institution. [ABSTRACT FROM AUTHOR]

Patient and public involvement (PPI) is the active partnership between researchers, patients, and the public in the process of creating and conducting research. The aim of this study was to report the barriers to becoming involved in research as patient partners for people with aphasia (PWA). Semi structured interviews were conducted online with eight people with chronic stroke: four with aphasia and four without. Interviews were subject to thematic analysis. Four key themes were generated for consideration: (1) the types of restrictions that make involvement difficult, (2) the preferred ways of involvement, (3) the support required for meaningful involvement, and (4) the impact of involving "patients" for the research outcomes. Patient groups are willing to be actively involved in research teams if the necessary support for participation is provided. The BEFORE recommendations are available for researchers to consider before initiating coproduced research with stroke and aphasia groups. [ABSTRACT FROM AUTHOR]

Radiofrequency ablation (RFA) has been a representative, non-surgical treatment for benign thyroid nodules that cause cosmetic problems or compression symptoms. The procedure of RFA should be performed effectively and safely. This review discusses the patient selection, pre-procedure evaluation and planning, principles, devices, techniques, and complications with reference to the guidelines and research on thyroid RFA. In particular, this review will devote to introduce RFA techniques and to provide practical help in the implementation of this procedure. [ABSTRACT FROM AUTHOR]

Obesity and obstructive sleep apnea are considered independent risk factors that can adversely affect perioperative outcomes. A combination of these two conditions in the ambulatory surgery patient can pose significant challenges for the anesthesiologist. Nevertheless, these patients should not routinely be denied access to ambulatory surgery. Instead, patients should be appropriately optimized. Anesthesiologists and surgeons must work together to implement fast-track anesthetic and surgical techniques that will ensure successful ambulatory outcomes. [ABSTRACT FROM AUTHOR]

The submental island flap (SIF) is a reliable option for reconstruction of the defects of the oral cavity following cancer resection. Advantages include reliable axial vascular pedicle, low donor site morbidity, good functional and cosmetic outcome, shorter operative time and lower cost compared to free flap reconstruction. A total of 32 consecutive patients with carcinoma of the oral cavity were included in this study. All patients underwent resection and immediate reconstruction with SIF pedicled the submental vessels. Donor and recipient site morbidity, functional outcome, and locoregional recurrences are reported. The study included 22 males (69%) and 10 females. The mean age was 54 years (range of 31–79 years). The most common primary tumor site was the tongue (15 patients, 47%), followed by the buccal mucosa, alveolar margin, floor of mouth, lower lip and hard palate. In 25 patients (78%) the flap survived completely. Complete flap loss occurred in one patient (3%). Six patients (19%) developed complications related to flap vascularity. 21 patients (66%) resumed normal diet, while 11 patients (34%) tolerated only soft diet. Over a median follow up was of 15 months (range of 3–62 months), 21 patients (66%) are alive and disease free, while 8 patients died, of whom 4 of locoreginal recurrences. SIF is reliable for reconstruction of the intraoral soft tissue defects following cancer resection. The functional and cosmetic outcomes are satisfactory and donor site morbidity is low. Careful patient selection is necessary for favorable outcome. [ABSTRACT FROM AUTHOR]

To analyze the factors that patients consider when choosing plastic surgeons and investigate patients' attitudes toward physicians' aesthetic ability and their adherence toward same-gender physicians. A cross-sectional study was conducted. All patients who presented for evaluation and management between January and April 2022 were eligible for study enrolment. Data collected include demographical information and specific questions related to choosing plastic surgeons, including physician's education, surgical ability, research, title, appearance, dress, age, aesthetics, the patient's preference for physicians' gender, and the way of learning about physicians. 1006 valid respondents participated, and the average age was 46.44 ± 15.51 years old (participation rate 99.60%). 72.5% were female. Plastic surgery history (OR 3.242, 95%CI: 1.664–6.317, p = 0.001), education (OR 1.895, 95%CI: 1.064–3.375, p = 0.030), income (OR 1.340, 95%CI: 1.026–1.750, p = 0.032), sexual orientation (OR 1.662, 95%CI: 1.066–2.589, p = 0.025), and concern for the physicians' appearance (OR 1.564, 95%CI: 1.160–2.107, p = 0.003) were significantly associated with patients' tendency to value physicians' aesthetic ability. Marital status (OR 0.766, 95% CI: 0.616–0.951, p = 0.016), income (OR 0.896,95% CI: 0.811–0.990, p = 0.031), the attention to physicians' age (OR 1.191,95% CI: 1.031–1.375, p = 0.017), and the attention to physicians' aesthetic ability (OR 0.775,95% CI: 0.666–0.901, p = 0.001) were significantly associated with the respondents' same-gender adherence degree. These findings suggest that patients with plastic surgery history, higher income, higher education background, and more diverse sexual orientation paid more attention to physicians' aesthetic ability. Marriage and income would affect the same-gender adherence degree, which would further influence patients' attention to the doctor's age and aesthetic ability. [ABSTRACT FROM AUTHOR]

Patients with hypercapnic COPD appear to represent a phenotype driven by specific physiology including air trapping and mechanical disadvantage, sleep hypoventilation, and sleep apnea. Such individuals appear to be at high risk for adverse health outcomes. Home noninvasive ventilation (NIV) has been shown to have the potential to help compensate for physiological issues underlying hypercapnia. In contrast to older literature, contemporary clinical trials of home NIV have been shown to improve patient-oriented outcomes including quality of life, hospitalizations, and mortality. Advancements in the use of NIV, including the use of higher inspiratory pressures, may account for recent success. Successful practical application of home NIV thus requires an adequate understanding of patient selection, devices and modes, and strategies for titration. The emergence of telemonitoring holds promise for further improvements in patient care by facilitating titration, promoting adherence, troubleshooting issues, and possibly predicting exacerbations. Given the complexity of home NIV, clinicians and health systems might consider establishment of dedicated home ventilation programs to provide such care. In addition, incorporation of respiratory therapist expertise is likely to improve success. Traditional fee-for-service structures have been a challenge for financing such programs, but ongoing changes toward value-based care are likely to make home NIV programs more feasible. [ABSTRACT FROM AUTHOR]

Research on online doctor-patient interaction is vast but has rarely examined its internal factors from a psychological point of view. Drawing on interpersonal attraction theory, this study explores whether potential personality traits of doctors and patients strengthen or weaken the behavior of patient selection and the contingent roles of patient psychological stress and doctor's title in online doctor-patient interaction. We leverage text mining in combination with econometrics techniques and studying the online doctor-patient interaction text data from a total of 245,027 consultations with 961 doctors in a large online health community in China, and we found that doctor-patient personality similarity plays a primary role in inducing patients selection behavior. Particularly, similarities in the openness, conscientiousness, and agreeableness dimensions of personality attract more patient selection, in contrast to similarities in the extroversion and neuroticism dimensions. In addition, patient psychological stress and the doctor's title both strengthen the link between doctor-patient personality similarity and patient selection. Grounded in the perspective of social psychology, this study reveals the mechanism and influence of personality traits on doctors' online services provided to patients, and it implies that doctors and patients with high personality similarities could be productively matched to facilitate high-quality service delivery. [ABSTRACT FROM AUTHOR]

To investigate aligner treatment protocols among orthodontists in the United States and Canada and assess the factors influencing clinician choices in aligner systems, treatment protocols, and targeted malocclusions for aligners. A validated online questionnaire was developed specifically for this research and consisted of three sections. Section 1 evaluated demographics and experience with aligners. Section 2 assessed patient selection and demands and clinician confidence in treating various malocclusions with aligners. Section 3 evaluated treatment protocols used by clinicians. The American Association of Orthodontists Partners in Research Program distributed the survey via e-mail to active members in the United States and Canada. A total of 160 providers completed the survey. Aligners were used by 65.00% of respondents, with the Invisalign system the most popular (81.25%). Aligners were mostly used for adults (97.50%). Tipping was ranked as the easiest movement (1.79 ± 1.35). Extrusion (4.34 ± 1.53) and root movement (4.31 ± 1.27) were ranked as the most difficult. Most were confident treating mild (98.8%) and moderate (82.5%) crowded cases, spacing (96.9%), and anterior crossbite (85%). Of the providers, 58.12% recommended aligners to be changed weekly. Respondents who were confident addressing some of the severe malocclusions were more likely to use Invisalign. Invisalign is the most popular aligner system, and clinicians seem to be confident using it. Providers are aware of the pitfalls of aligners; they find it challenging to perform root movement and extrusion, and they seem confident treating mild to moderate malocclusions. They avoid complex cases with impactions and severe skeletal problems. [ABSTRACT FROM AUTHOR]

Objective: Recruitment of a sufficiently large and representative patient sample and its retention during central nervous system (CNS) trials presents major challenges for study sponsors. Technological advances are reshaping clinical trial operations to meet these challenges, and the COVID-19 pandemic further accelerated this development. Method of Research: The International Society for CNS Clinical Trials and Methodology (ISCTM; www.isctm.org) Innovative Technologies for CNS Trials Working Group surveyed the state of technological innovations for improved recruitment and retention and assessed their promises and pitfalls. Results: Online advertisement and electronic patient registries can enhance recruitment, but challenges with sample representativeness, conversion rates from eligible prescreening to enrolled patients, data privacy and security, and patient identification remain hurdles for optimal use of these technologies. Electronic medical records (EMR) mining with artificial intelligence (AI)/machine learning (ML) methods is promising but awaits translation into trials. During the study treatment phase, technological innovations increasingly support participant retention, including adherence with the investigational treatment. Digital tools for adherence and retention support take many forms, including patient-centric communication channels between researchers and participants, real-time study reminders, and digital behavioral interventions to increase study compliance. However, such tools add technical complexities to trials, and their impact on the generalizability of results are largely unknown. Conclusion: Overall, the group found a scarcity of systematic data directly assessing the impact of technological innovations on study recruitment and retention in CNS trials, even for strategies with already high adoption, such as online recruitment. Given the added complexity and costs associated with most technological innovations, such data is needed to fully harness technologies for CNS trials and drive further adoption. [ABSTRACT FROM AUTHOR]

Therapeutic targeting of the transforming growth factor beta (TGFβ) pathway in cancer represents a clinical challenge since TGFβ exhibits either tumor suppressive or tumor promoting properties, depending on the tumor stage. Thus, treatment with galunisertib, a small molecule inhibitor of TGFβ receptor type 1, demonstrated clinical benefits only in subsets of patients. Due to the functional duality of TGFβ in cancer, one can hypothesize that inhibiting this pathway could result in beneficial or adverse effects depending on tumor subtypes. Here, we report distinct gene expression signatures in response to galunisertib in PLC/PRF/5 and SNU‐449, two cell lines that recapitulate human hepatocellular carcinoma (HCC) with good and poor prognosis, respectively. More importantly, integrative transcriptomics using independent cohorts of patients with HCC demonstrates that galunisertib‐induced transcriptional reprogramming in SNU‐449 is associated with human HCC with a better clinical outcome (i.e., increased overall survival), while galunisertib‐induced transcriptional reprogramming in PLC/PRF/5 is associated with human HCC with a worse clinical outcome (i.e., reduced overall survival), demonstrating that galunisertib could indeed be beneficial or detrimental depending on HCC subtypes. Collectively, our study highlights the importance of patient selection to demonstrate a clinical benefit of TGFβ pathway inhibition and identifies Serpin Family F Member 2 (SERPINF2) as a putative companion biomarker for galunisertib in HCC. [ABSTRACT FROM AUTHOR]

Purpose: Chronic stress related to health disparities results in negative health outcomes for mothers and infants. The brain-gut-immune axis plays a significant role in perinatal health outcomes. Researchers have not focused on the effects of rural living on the maternal/infant gut microbiome. The purpose of our study was to validate recruitment protocols, data and specimen collection protocols, participant feedback, and participant retention strategies for future studies in a rural Nebraska population of mother/infant dyads. Sample: Mother/infant dyads living in Nebraska counties with a rural-urban commuting area (RUCA) code of three or greater (n = 17 dyads, n = 1 triad). Methods: We conducted a cross-sectional pilot feasibility study by collecting stool samples, actigraph data, sleep diaries, and health and lifestyle questionnaires from mother/infant dyads living in rural Nebraska counties. Findings: Retrospective review of this pilot study identified the main feasibility findings were primarily related to distance: 1) relying on virtual recruiting methods was cost-effective; 2) stool sample shelf-life created participant inconvenience; 3) shipping carrier delays affected collection timing of actigraph data; 4) participant access to shipping carrier drop-offs increased cost and inconvenience. Conclusion: Rural locations create barriers to research, but none are insurmountable. When working with rural populations, it is important to consider the potential adaptation of participant recruitment methods and protocol procedures, including careful attention to shipping and related time constraints that may impact data collection. [ABSTRACT FROM AUTHOR]

Breast cancer is the most common cancer in women worldwide. Over the past few decades, remarkable progress has been made in understanding the biology and pathology of breast cancer. A personalized conservative approach has been currently adopted addressing the patient's individual risk of relapse. After postoperative whole breast irradiation for early-stage breast cancer, a rate of recurrences outside the initial tumour bed lower than 4% was observed. Thus, the highest benefits of breast irradiation seem to result from the dose delivered to the tissue neighbouring the tumour bed. Nonetheless, reducing treatment morbidity while maintaining radiation therapy's ability to decrease local recurrences is an important challenge in treating patients with radiation therapy. In this regard, strategies such as partial-breast irradiation have been developed to reduce toxicity without compromising oncologic outcomes. According to the national and international published guidelines, clinical oncologists can refer to specific dose/fractionation schedules and eligible criteria. However, there are still some areas of open questions. Breast cancer represents a multidisciplinary paradigm; it should be considered a heterogeneous disease where a "one-treatment-fits-all" approach cannot be considered an appropriate option. This is a wide overview on the main partial breast irradiation advantages, risks, timings, techniques, and available recommendations. We aim to provide practical findings to support clinical decision-making, exploring future perspectives, towards a balance for optimisation of breast cancer. • A personalized conservative approach address patient's individual risk of relapse. • A "one-treatment-fits-all" approach is not appropriate for breast cancer. • Partial breast irradiation as balance for breast cancer treatment optimisation. • Suitable criteria for partial breast irradiation should be followed for patient selection. [ABSTRACT FROM AUTHOR]

Trends over the past decade suggest a steady increase in the proportion of total knee arthroplasty (TKA) performed on an outpatient basis. However, the optimal patient selection criteria for outpatient TKA remain unclear. We aimed to describe longitudinal trends in patients selected for outpatient TKA and identify risk factors for 30-day morbidity following inpatient and outpatient TKA. We identified 379,959 primary TKA patients, 17,170 (4.5%) of whom underwent outpatient surgery from 2012 to 2020 within a large national database. We used regression models to evaluate trends in outpatient TKA, factors associated with undergoing outpatient (versus inpatient) TKA and 30-day morbidity following outpatient and inpatient TKA. We used receiver operating curves to examine cutoff points for continuous risk factors. The proportion of patients undergoing outpatient TKA increased from 0.4% in 2012 to 14.1% in 2020. Younger age, male sex, lower body mass index (BMI), higher hematocrit, and fewer comorbidities were associated with receiving outpatient (versus inpatient) TKA. Variables associated with 30-day morbidity in the outpatient group included older age, chronic dyspnea, chronic obstructive pulmonary disease, and higher BMI. The receiver operating curves indicated outpatients aged 68 years and older, or with a BMI of 31.4 or higher were more likely to experience 30-day complications. The proportion of patients undergoing outpatient TKA has been increasing since 2012. Older age (≥68 years), a higher BMI (≥31.4), and comorbidities such as chronic dyspnea, chronic obstructive pulmonary disease, diabetes, and hypertension were associated with an increased odd of 30-day morbidity following outpatient TKA. [ABSTRACT FROM AUTHOR]

Risk stratification tools are being increasingly utilized to guide patient selection for outpatient shoulder arthroplasty. The purpose of this study was to identify the existing calculators used to predict discharge disposition, postoperative complications, hospital readmissions, and patient candidacy for outpatient shoulder arthroplasty and to compare the specific components used to generate their prediction models. This review was conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analysis protocol. PubMed, Cochrane Library, Scopus, and OVID Medline were searched for studies that developed calculators used to determine patient candidacy for outpatient surgery or predict discharge disposition, the risk of postoperative complications, and hospital readmissions after anatomic or reverse total shoulder arthroplasty (TSA). Reviews, case reports, letters to the editor, and studies including hemiarthroplasty cases were excluded. Data extracted included authors, year of publication, study design, patient population, sample size, input variables, comorbidities, method of validation, and intended purpose. The pros and cons of each calculator as reported by the respective authors were evaluated. Eleven publications met inclusion criteria. Three tools assessed patient candidacy for outpatient TSA, 3 tools evaluated the risk of 30- or 90-day hospital readmission and postoperative complications, and 5 tools predicted discharge destination. Four calculators validated previously constructed comorbidity indices used as risk predictors after shoulder arthroplasty, including the Charlson Comorbidity Index, Elixhauser Comorbidity Index, modified Frailty Index, and the Outpatient Arthroplasty Risk Assessment, while 7 developed newcalculators. Nine studies utilized multiple logistic regression to develop their calculators, while 1 study developed their algorithm based on previous literature and 1 used univariate analysis. Five tools were built using data from a single institution, 2 using data pooled from 2 institutions, and 4 from large national databases. All studies used preoperative data points in their algorithms with one tool additionally using intraoperative data points. The number of inputs ranged from 5 to 57 items. Four calculators assessed psychological comorbidities, 3 included inputs for substance use, and 1 calculator accounted for race. The variation in perioperative risk calculators after TSA highlights the need for standardization and external validation of the existing tools. As the use of outpatient shoulder arthroplasty increases, these calculators may become outdated or require revision. Incorporation of socioeconomic and psychological measures into these calculators should be investigated. [ABSTRACT FROM AUTHOR]

Representativeness is perhaps one of the most important requirements in medical research, especially for health disparities research. Representativeness is necessary for the study findings to apply to all members of the population without selection bias. Here we detail the multiple approaches to ensuring representativeness that were developed in the HANDLS (Healthy Aging in Neighborhoods of Diversity across the Life Span) study. (Funded by the National Institute on Aging Intramural Research Program, National Institutes of Health; ClinicalTrials.gov number, NCT01323322.) [ABSTRACT FROM AUTHOR]

This case report describes the camouflage treatment of an adult patient with hyperdivergent facial pattern presenting with severe Class II skeletal malocclusion, through the use of a hybrid clear aligner approach, that relies on both a partial lingual fixed appliance and the continuous use of Class II elastics throughout therapy. After 11 months of treatment, the goals had been achieved, highlighting that the correct diagnostic framework, proper patient selection and careful digital planning of a compromise treatment can provide satisfactory aesthetic and functional outcomes. [ABSTRACT FROM AUTHOR]