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The test-retest (TRT) reliability of FACE-Q Aesthetic scales is yet to be assessed. The aim of this study was to establish the TRT reliability of 17 FACE-Q Aesthetic scales and determine the smallest detectable change (SDC) that can be identified using these scales. Data were collected from an online international sample platform (Prolific). Participants ≥20 years old, who had been to a dermatologist or plastic surgeon for a facial aesthetic treatment within the past 12 months were asked to provide demographic and clinical information and complete an online REDcap survey consisting of 17 FACE-Q Aesthetic scales. Participants were asked if they would be willing to complete the survey again in 7 days. Only the participants who reported no important change in the scale construct and completed the retest within 14 days were included. A total of 342 unique participants completed the TRT survey. The mean age of the sample was 36.6 (±11.5) years, and 82.4% were female. With outlier data removed, all FACE-Q scales demonstrated an intraclass correlation coefficient >0.70 indicating "good" TRT reliability. The standard error of measurement for the included scales ranged from 3.37 to 11.87, corresponding to a range of SDC group from 0.95 to 3.23 and SDC ind from 9.34 to 32.91. All included FACE-Q scales demonstrated sufficient TRT reliability and stability overall after the outlier data were removed. Moreover, the authors calculated the values for the SDC for these scales. [ABSTRACT FROM AUTHOR]

The BREAST-Q Breast Cancer module is a patient-reported outcome measure for women with breast cancer diagnosis. Our research team developed and validated a novel BREAST-Q scale for this module that measures quality of life outcomes specific to cancer worry. The aim of this study was to investigate patient related breast reconstruction factors that are associated with worse scores on the new BREAST-Q Cancer Worry Scale. Women with a history of breast cancer treated with mastectomy and reconstruction, aged ≥18 years, and English-speaking were recruited through the Love Research Army between October and November 2019. Participants completed demographic and clinical questions alongside the BREAST-Q Cancer Worry Scale. Univariable and multivariable regression analyses were used to identify participant characteristics associated with cancer worry scores. Among the 554 potential respondents, 538 (97.1%) completed the Cancer Worry Scale. The average patient age was 58.4 (+ 9.8) years. Cancer Worry scores were normally distributed with a mean of 46.4 (+ 17.2). Cancer Worry scores were significantly associated (p < 0.01) with younger age, history of radiation therapy, complications associated with breast surgery since diagnosis, use of textured breast implants, and shorter duration since surgery. This exploratory analysis provides evidence of patient characteristics that may be associated with cancer worry following postmastectomy breast reconstruction. [ABSTRACT FROM AUTHOR]

We developed a web-based tool to measure the amount and rate of skill acquisition in pediatric interproximal caries diagnosis among pre- and postdoctoral dental students and identified variables predictive for greater image interpretation difficulty. In this multicenter prospective cohort study, a convenience sample of pre- and postdoctoral dental students participated in computer-assisted learning in the interpretation of bitewing radiographs of 193 children. Participants were asked to identify the presence or absence of interproximal caries and, where applicable, locate the lesions. After every case, participants received specific visual and text feedback on their diagnostic performance. They were requested to complete the 193-case set but could complete enough cases to achieve a competency performance standard of 75% accuracy, sensitivity, and specificity. Of 130 participants, 62 (47.7%) completed all cases. The mean change from initial to maximal diagnostic accuracy was +15.3% (95% CI, 13.0-17.7), sensitivity was +10.8% (95% CI, 9.0-12.7), and specificity was +15.5% (95% CI, 12.9-18.1). The median number of cases completed to achieve competency was 173 (interquartile range, 82-363). Of these 62 participants, 45 (72.6%) showed overall improvement in diagnostic accuracy. Greater numbers of interproximal lesions (P <.001) and the presence of noninterproximal caries (P <.001) predicted greater interpretation difficulty. Computer-assisted learning led to improved diagnosis of interproximal caries on bitewing radiographs among pre- and postdoctoral dental students. [ABSTRACT FROM AUTHOR]

Booster doses for COVID-19 vaccinations have been shown to amplify the waning immune response after primary vaccination and to enhance protection against emerging variants of concern (VoCs). Here, we aimed to assess the immunogenicity and safety of a booster dose of an inactivated whole-virus COVID-19 vaccine (VLA2001) after primary vaccination with 2 doses of either VLA2001 or ChAdOx1-S (Oxford-Astra Zeneca), including the cross-neutralization capacity against the Delta and Omicron VoCs. This interim analysis of an open-label extension of a randomized, controlled phase 3 trial assessed a single booster dose of an inactivated whole-virus COVID-19 vaccine (VLA2001) in healthy or medically stable adults aged 18 years and above, recruited in 21 clinical sites in the UK, who had previously received two doses of either VLA2001 or ChAdOx1-S. Safety outcomes were frequency and severity of solicited injection site and systemic reactions within 7 days after booster vaccination as well as frequency and severity of any unsolicited adverse events (AE) after up to 6 months. Immunogenicity outcomes were the immune response to ancestral SARS-CoV-2 assessed 14 days post booster expressed as geometric mean titres (GMT), GMT fold ratios and seroconversion of specific neutralizing antibodies and S-protein binding IgG antibodies. Immunogenicity against the Delta and Omicron VoCs was assessed as a post-hoc outcome with a pseudovirus neutralization antibody assay. This study is registered with ClinicalTrials.gov, NCT04864561 , and is ongoing. A booster dose of VLA2001 was administered to 958 participants, of whom 712 had been primed with VLA2001, and 246 with ChAdOx1-S. Within 7 days following these booster doses, 607 (63.4%) participants reported solicited injection site reactions, and 487 (50.8%) reported solicited systemic reactions. Up to 14 days post booster, 751 (78.4%) participants reported at least one adverse event. The tolerability profile of a booster dose of VLA2001 was similar in VLA2001-primed and ChAdOx1-S-primed participants. In VLA2001-primed participants, the GMT (95% CI) of neutralizing antibodies increased from 32.5 (22.8, 46.3) immediately before to 521.5 (413.0, 658.6) 2 weeks after administration of the booster dose, this corresponds to a geometric mean fold rise (GMFR) of 27.7 (20.0, 38.5). Compared to 2 weeks after the second priming dose, the GMFR was 3.6 (2.8, 4.7). In the ChAdOx1-S primed group, the GMT (95% CI) of neutralizing antibodies increased from 65.8 (43.9, 98.4) immediately before to 188.3 (140.3, 252.8) 2 weeks after administration of the booster dose, a geometric mean fold rise (GMFR) of 3.0 (2.2, 4.0). Compared to 2 weeks after the second priming dose, the GMFR was 1.6 (1.1, 2.2). For S-protein binding IgG antibodies, the pre- versus post-booster GMT fold ratio (95% CI) was 34.6 (25.0, 48.0) in the VLA2001-primed group and 4.0 (3.0, 5.2) in the ChAdOx1-S-primed group. Compared to 2 weeks after the second priming dose, the GMT fold rise of IgG antibodies was 3.8 (3.2, 4.6) in the VLA2001-primed group and 1.2 (0.9, 1.6) in the ChAdOx1-S-primed group. The GMT against Delta (B.1.617.2) and Omicron (BA.4/5) increased from 4.2 to 260, and from 2.7 to 56.7, respectively, when boosting subjects previously primed with VLA2001. Following the boost, 97% of subjects primed with VLA2001 had detectable Delta- and 94% Omicron-neutralizing antibodies. In subjects primed with ChAdOx1-S, the GMT against Delta and Omicron titres increased from 9.1 to 92.5, and from 3.6 to 12.3, respectively. After boosting, 99% of subjects primed with ChAdOx1-S had detectable Delta- and 70% Omicron-neutralizing antibodies. In both VLA2001 and ChAdOx1-S primed subjects, the additional VLA2001 dose boosted T cell responses against SARS-CoV-2 antigens to levels above those observed before the booster dose. A booster dose of VLA2001 was safe and well tolerated after primary immunization with VLA2001 and ChAdOx1-S. The tolerability of a booster dose of VLA2001 was similar to the favourable profile observed after the first and second priming doses. Both in a homologous and a heterologous setting, boosting resulted in higher neutralizing antibody titres than after primary immunization and significant increases in cross-neutralization titres against Delta and Omicron were observed after the booster dose. These data support the use of VLA2001 in booster programmes in ChadOx1-S primed groups. • A booster dose of VLA2001 was well-tolerated in participants previously primed with 2 doses of either ChAdOx1-S or VLA2001. • Neutralizing titers after a booster dose of VLA2001 were higher than after priming. • Neutralizing titers after a booster doses were 28-fold (VLA2001 primed) and 3-fold (ChAdOx1-S primed) higher than after booster. [ABSTRACT FROM AUTHOR]

To elicit a patient-prioritized agenda and preferences for upper extremity lymphedema (LE) research. Focus group sessions (FGs) were conducted with English-speaking, adult women (18 years and older) with breast cancer-related LE (BCRL) seeking conservative or surgical care at two tertiary cancer centers in Ontario, Canada. An interview guide was used; women were asked to describe health-related quality of life (HRQL) outcomes that mattered the most to them, followed by their preferences for research study design and for providing patient-reported outcomes measure (PROM) data. Inductive content analysis was used to identify themes and subthemes. A total of 16 women participated in 4 FG sessions (55 ± 9.5 years) and described the impact of LE on their appearance, physical, psychosocial, and sexual well-being. Women emphasized that psychosocial well-being was often not discussed in clinical care and that they were poorly informed of LE risk and care options. Most women said that they would not be willing to be randomized to surgical versus conservative management of LE. They also expressed a preference to complete PROM data electronically. All women emphasized the value of having an open text option alongside PROMs to expand on their concerns. Patient centeredness is key to generating meaningful data and ensuring ongoing engagement in clinical research. In LE, comprehensive PROMs that measure a range of HRQL concerns, especially psychosocial well-being, should be considered. Women with BCRL are reluctant to be randomized to conservative care when a surgical option is available, resulting in implications for planning trial sample size and recruitment. [ABSTRACT FROM AUTHOR]

Patients with Stage IV breast cancer are living longer but breast reconstruction in this setting remains controversial. There is limited research evaluating the benefits of breast reconstruction in this patient cohort. Drawing from the Mastectomy Reconstruction Outcomes Consortium (MROC) dataset, a prospective cohort study that involved 11 leading medical centers in the US and Canada, we compared patient-reported outcomes (PROs) assessed utilizing the BREAST-Q, a condition-specific, validated patient-reported outcome measure (PROM) for mastectomy reconstruction, as well as complications between a cohort of patients with Stage IV disease undergoing reconstruction and a control group of women with Stage I-III disease also receiving reconstruction. Among the MROC population, 26 patients with Stage IV and 2613 women with Stage I-III breast cancer underwent breast reconstruction. Preoperatively, the Stage IV cohort reported significantly lower baseline scores for satisfaction with breast (p = 0.004), psychosocial well-being (p = 0.043) and sexual well-being (p = 0.001), compared with Stage I-III women. Following breast reconstruction, Stage IV patients' mean PRO scores improved over baseline and were not significantly different from those of Stage I-III reconstruction patients. There were also no significant differences in overall/any (p = 0.782), major (p = 0.751) or minor complication (p = 0.787) rates between the two groups at two years following reconstruction. The findings in this study suggest that breast reconstruction offers significant quality-of-life benefits for women with advanced breast cancer with no increase in postoperative complications and thus may be a reasonable option in this clinical setting. [ABSTRACT FROM AUTHOR]

Chest masculinization surgery is the most common gender-affirming procedure performed in transgender and gender-diverse individuals. While evidence on the health-related quality of life (HRQL) impact of chest masculinization is starting to emerge, data on health state utility values (HSUVs) associated with the surgery is largely missing. The objectives of this study were to estimate the HSUVs using EQ-5D for patients seeking chest masculinization surgery and assess the determinants of EQ-5D score at 6 months postoperatively. Patients seeking chest masculinization at a single community plastic surgery clinic by 2 surgeons completed 3 patient-reported outcome measures – EQ-5D-3L, Patient Health Questionnaire (PHQ)-9, and BODY-Q Chest module – preoperatively and postoperatively at 6 weeks and 6-months. Friedman test was used to assess the differences in PROM scores at the 3 timepoints. Simple and backward stepwise regression analyses of 6-month postoperative EQ-5D scores were performed. A total of 113 patients (mean [SD] age, 25.7 [6.9] years) were included. The mean [SD] EQ-5D scores at preoperative, postoperative 6 weeks and 6 months were 0.81 [0.15], 0.84 [0.15] and 0.87 [0.12], respectively. Postoperatively, problems were most frequently reported in the dimensions "pain/discomfort" and "anxiety/depression". Preoperative PHQ-9 score was a predictor of 6-month postoperative EQ-5D scores following simple (p < 0.01) and backward stepwise linear regression analysis (p < 0.01). Chest masculinization was associated with an improvement in overall HRL at 6 months postoperatively; however, this did not achieve statistical significance. Preoperative depression severity was a significant determinant of postoperative HRL. Consequently, additional support must be offered to patients who have a higher level of preoperative depression. [ABSTRACT FROM AUTHOR]

Limb-threatening injuries can have a profound impact on patient lives. The impact on a patient's psychosocial well-being is widespread yet not well understood. This study aims to explore which psychosocial elements are central to patient experiences after limb-threatening lower extremity trauma. This is a qualitative interview-based study to identify psychosocial experiences after limb-threatening lower extremity trauma in a patient-centered manner. Data were collected via semi-structured qualitative interviews and analyzed via an interpretive description approach. Interviews were performed until content saturation was reached. A total of 33 interviews were performed until reaching content saturation. Eleven participants underwent early amputation, 7 delayed amputation after an attempt at limb salvage, and 15 underwent limb salvage. A total of 533 unique psychosocial codes were identified, comprised of eight concepts: acceptance, body image, coping, distress, positive impact, emotional support, isolation, and intrapsychic. This study identified the concerns central to this patient population and developed a conceptual framework for how patients cope with these psychosocial experiences. These findings underscore the importance of developing resilience by actively practicing acceptance and reaching more positive mental health outcomes. Additionally, these findings highlight the importance of increasing access to early and routine psychological and social support for patients with severe lower extremity trauma. [ABSTRACT FROM AUTHOR]

Demand for nipple- and skin- sparing mastectomy (NSM/SSM) with immediate breast reconstruction (BR) has increased at the same time as indications for post-mastectomy radiation therapy (PMRT) have broadened. The aim of the Oncoplastic Breast Consortium initiative was to address relevant questions arising with this clinically challenging scenario. A large global panel of oncologic, oncoplastic and reconstructive breast surgeons, patient advocates and radiation oncologists developed recommendations for clinical practice in an iterative process based on the principles of Delphi methodology. The panel agreed that surgical technique for NSM/SSM should not be formally modified when PMRT is planned with preference for autologous over implant-based BR due to lower risk of long-term complications and support for immediate and delayed-immediate reconstructive approaches. Nevertheless, it was strongly believed that PMRT is not an absolute contraindication for implant-based or other types of BR, but no specific recommendations regarding implant positioning, use of mesh or timing were made due to absence of high-quality evidence. The panel endorsed use of patient-reported outcomes in clinical practice. It was acknowledged that the shape and size of reconstructed breasts can hinder radiotherapy planning and attention to details of PMRT techniques is important in determining aesthetic outcomes after immediate BR. The panel endorsed the need for prospective, ideally randomised phase III studies and for surgical and radiation oncology teams to work together for determination of optimal sequencing and techniques for PMRT for each patient in the context of BR • Autologous breast reconstruction is increasingly preferred over implants in the setting of radiation therapy. • Use of patient-reported outcomes is endorsed. • Shape and size of reconstructed breasts can hinder radiotherapy planning. • There is a need for randomised phase III trials. [ABSTRACT FROM AUTHOR]

Facial vascularized composite allotransplantation (fVCA) is a life-enhancing procedure performed to improve quality of life (QOL). Patient-reported outcome measures (PROMs) are tools used to assess QOL from the patients' perspective, and are increasingly recognized as an important clinical metric to assess outcomes of treatment. A systematic literature review was performed to identify and appraise the content of PROMs used in fVCA. We searched PUBMED/Medline, CINAHL, Embase, PsychInfo, and Web of Science from their inception through to June 2020. Included studies used a PROM in candidates and recipients of fVCA of any gender or age. We excluded abstracts, reviews, editorials, and dissertations. Items from each PROM were extracted and coded, using top-level codes and subcodes, to develop a preliminary conceptual framework of QOL concerns in fVCA, and to guide future PROM selection. Title and abstract screening of 6089 publications resulted in 16 studies that met inclusion criteria. Review of the 16 studies identified 38 PROMs, none of which were developed for fVCA. Review of the coded content for each PROM identified six top-level codes (appearance, facial function, physical, psychological and social health, and experience of care) and 16 subcodes, making up the preliminary conceptual framework. There are currently no PROMs designed to measure QOL concerns of fVCA candidates and recipients. Findings from this systematic review will be used to inform an interview guide for use in qualitative interviews to elicit and refine important concepts related to QOL in fVCA. [ABSTRACT FROM AUTHOR]

Women undergoing cancer-related mastectomy and reconstruction are facing multiple treatment choices where post-surgical satisfaction with breasts is a key outcome. We developed and validated machine learning algorithms to predict patient-reported satisfaction with breasts at 2-year follow-up to better inform the decision-making process for women with breast cancer. We trained, tested, and validated three machine learning algorithms (logistic regression (LR) with elastic net penalty, Extreme Gradient Boosting (XGBoost) tree, and neural network) to predict clinically important differences in satisfaction with breasts at 2-year follow-up using the validated BREAST-Q. We used data from 1553 women undergoing cancer-related mastectomy and reconstruction who were followed-up for two years at eleven study sites in North America from 2011 to 2016. 10-fold cross-validation was used to train and test the algorithms on data from 10 of the 11 sites which were further validated using the additional site's data. Area-under-the-receiver-operating-characteristics-curve (AUC) was the primary outcome measure. Of 1553 women, 702 (45.2%) experienced an improved satisfaction with breasts and 422 (27.2%) a decreased satisfaction. In the validation set (n = 221), the algorithms showed equally high performance to predict improved or decreased satisfaction with breasts (all P > 0.05): For improved satisfaction AUCs were 0.86–0.87 and for decreased satisfaction AUCs were 0.84–0.85. Long-term, individual patient-reported outcomes for women undergoing mastectomy and breast reconstruction can be accurately predicted using machine learning algorithms. Our algorithms may be used to better inform clinical treatment decisions for these patients by providing accurate estimates of expected quality of life. • Optimal treatment for women undergoing mastectomy and reconstruction is unclear. • Can machine learning algorithms predict long-term patient-reported outcomes? • An international cohort of 1553 women was used for the algorithm development. • External validation showed good performance with AUCs of 0.84–0.87 • accurate estimates of expected quality of life may help inform treatment decisions. [ABSTRACT FROM AUTHOR]

There is currently a lack of patient-reported outcome measures for ear reconstruction. We developed the EAR-Q to measure ear appearance and post-operative adverse effects from the patient perspective. Field-test data were collected from children and young adults in eight countries between 13 May 2016 and 12 December 2019. Rasch measurement theory (RMT) analysis was used to refine the scales and to examine their psychometric properties. Participants had microtia (n = 607), prominent ears (n = 145) or another ear condition (n = 111), and provided 960 assessments for the Appearance scale (e.g., size, shape, photos), and 137 assessments for the Adverse Effects scale (e.g., itchy, painful, numb). RMT analysis led to the reduction of each scale to 10-items. Data fit the Rasch model for the Appearance (X2(80) = 90.9, p = 0.19) and Adverse Effects (X2(20) = 24.5, p = 0.22) scales. All items in each scale had ordered thresholds and good item fit. There was no evidence of differential item function for the Appearance scale by age, gender, language, or type of ear condition. Reliability was high for the Appearance scale, with person separation index (PSI) and Cronbach alpha values with and without extremes ≥0.92. Reliability for the Adverse Effects scale was adequate (i.e., PSI and Cronbach alpha values ≥0.71). Higher scores (liked appearance more) correlated with higher scores (better) on Psychological, Social and School scales. The EAR-Q can be used in those 8–29 years of age to understand the patient perspective in clinical practice and research, and in addition, can be used to benchmark outcomes for ear reconstruction internationally. [ABSTRACT FROM AUTHOR]

Electrocardiogram interpretation is an essential skill for emergency and critical care nurses and physicians. There remains a gap in standardized curricula and evaluation strategies used to achieve and assess competence in electrocardiogram interpretation. The purpose of this study was to develop an importance ranking of the 120 American Heart Association electrocardiogram diagnostic labels with interdisciplinary perspectives to inform curriculum development. Data for this mixed methods study were collected through focus groups and individual semi-structured interviews. A card sort was used to assign relative importance scores to all 120 American Heart Association electrocardiogram diagnostic labels. Thematic analysis was used for qualitative data on participants' rationale for the rankings. The 18 participants included 6 emergency and critical care registered nurses, 5 cardiologists, and 7 emergency medicine physicians. The 5 diagnoses chosen as the most important by all disciplines were ventricular tachycardia, ventricular fibrillation, atrial fibrillation, complete heart block, and normal electrocardiogram. The "top 20" diagnoses by each discipline were also reported. Qualitative thematic content analysis revealed that participants from all 3 disciplines identified skill in electrocardiogram interpretation as clinically imperative and acknowledged the importance of recognizing normal, life threatening, and time-sensitive electrocardiogram rhythms. Additional qualitative themes, identified by individual disciplines, were reported. This mixed-methods approach provided valuable interdisciplinary perspectives concerning electrocardiogram curriculum case selection and prioritization. Study findings can provide a foundation for emergency and critical care educators to create local ECG educational programs. Further work is recommended to validate the list amongst a larger population of emergency and critical care frontline nurses and physicians. [ABSTRACT FROM AUTHOR]

Measuring and benchmarking quality of care in surgical oncology has been gaining popularity. In autologous breast reconstruction (ABR), a standardized set of indicators to assess quality of care is lacking. In this study, we defined a set of evidence-based quality indicators for autologous breast reconstruction. First, we performed a systematic review to identify factors related to quality of care in ABR. Variables were categorized depending on their function: indicators related to outcome, indicators related to process and case-mix variables. The review was followed by a 3-round Delphi Consensus to determine which indicators and case-mix-variables were considered relevant and feasible for inclusion in an ABR standard set of indicators. 932 unique articles were identified, of which 110 papers were included in the study. Indicators were categorized by function: outcome, process and case-mix variables. In total, 8 process indicators and 41 outcome indicators were extracted. 30 case-mix-variables were included. Following 3 rounds of questioning in the Delphi Consensus, all respondents agreed on type of ABR, oncological outcomes and patient satisfaction for the standard set. Indicators related to complications were consistently ranked highly. Most process indicators were not chosen after 3 rounds of questioning. 11 case-mix-variables were included in the final set. Following the Delphi Consensus, it was possible to identify 33 process and outcome indicators and 11 case-mix-variables for inclusion for a standard set of quality indicators. With the inclusion of both objective and patient-reported outcome measures, this set of indicators provides a multidimensional measurement tool for quality assessment for ABR. [ABSTRACT FROM AUTHOR]

The International Consortium for Health Outcome Measurement (ICHOM) has recently agreed upon a core outcome set for the comprehensive appraisal of cleft care, which puts a greater emphasis on patient-reported outcome measures (PROMs) and, in particular, the CLEFT-Q. The CLEFT-Q comprises 12 scales with a total of 110 items, aimed to be answered by children as young as 8 years old. In this study, we aimed to use computerised adaptive testing (CAT) to reduce the number of items needed to predict results for each CLEFT-Q scale. We used an open-source CAT simulation package to run item responses over each of the full-length scales and its CAT counterpart at varying degrees of precision, estimated by standard error (SE). The mean number of items needed to achieve a given SE was recorded for each scale's CAT, and the correlations between results from the full-length scales and those predicted by the CAT versions were calculated. Using CATs for each of the 12 CLEFT-Q scales, we reduced the number of questions that participants needed to answer, that is, from 110 to a mean of 43.1 (range 34–60, SE < 0.55) while maintaining a 97% correlation between scores obtained with CAT and full-length scales. CAT is likely to play a fundamental role in the uptake of PROMs into clinical practice given the high degree of accuracy achievable with substantially fewer items. [ABSTRACT FROM AUTHOR]

Background: Assessments of surgical quality should consider both surgeon and patient perspectives simultaneously. Focusing on patients undergoing major gastrointestinal cancer surgery, we sought to characterize hospitals, and their patients, on both these axes of quality.Methods: Using the American College of Surgeons' National Surgical Quality Improvement Program registry, hospitals were profiled on a risk-adjusted composite measure of death or serious morbidity (DSM) generated from patients who underwent colectomy, esophagectomy, hepatectomy, pancreatectomy, or proctectomy for cancer between January 1, 2015 and December 31, 2016. These hospitals were also profiled using the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey. Highest-performing hospitals on both quality axes, and their respective patients, were compared to the lowest-performing hospitals.Results: Overall, 60,526 patients underwent their cancer operation at 530 hospitals. There were 38 highest- and 48 lowest-performing hospitals. The correlation between quality axes was poor (ρ = 0.10). Compared to the lowest-performing hospitals, the highest-performing hospitals were more often NCI-designated cancer centers (29.0% vs. 4.2%, p = 0.002) and cared for a lower proportion of Medicaid patients (0.14 vs. 0.23, p < 0.001). Patients who had their operations at the lowest- versus highest-performing hospitals were more often black (17.2% vs. 8.4%, p < 0.001), Hispanic (8.3% vs. 3.5%, p < 0.001), functionally dependent (3.8% vs. 0.9%, p < 0.001), and not admitted from home (4.4% vs. 2.4%, p < 0.001).Conclusions: Hospital performance varied when assessed by both risk-adjusted surgical outcomes and patient experiences. In this study, poor-performing hospitals appeared to be disproportionately serving disadvantaged and minority cancer patients. [ABSTRACT FROM AUTHOR]

Summary Background Well-designed implant registries have been shown to be a worthwhile investment, from both a health and economic perspective. However, many registries do not attain desirable capture rates or lack sufficient funding, potentially leading to premature termination. This study aims to provide information about rarely discussed, yet pivotal topics regarding the long-term survival of implant registries, focusing on costs, funding models, and the role of stakeholders. Methods Worldwide, relatively recently developed breast device (BD) registries were compared to long-standing, orthopaedic (OD) and cardiovascular device (CD) registries. A standardised questionnaire was sent to the registries’ designated representatives with key positions, discussing start-up costs, costs of maintenance, value of investment, governance, stakeholders, funding, and sustainability. Results Thirteen registries were included, originating from nine countries (seven BD registries, five OD registries, one CD registry). In general, start-up costs were comparable, and younger registries were more expensive to maintain. Numerous stakeholders showed interest in registry outcomes. However, only 50% of the registries reported a sustainable funding structure. Conclusion This study provides a global perspective on implantable device registries. All registries provided important information, serving three unique purposes by evaluating the quality of healthcare provided, the quality of all registered devices, and processing recall information. Yet, only half of the registries were certain of sustainable funding, and thus their future existence. It is of utmost importance to bring this to the attention of all parties involved. [ABSTRACT FROM AUTHOR]

Summary Background There is little evidence about the long-term donor site outcome of latissimus dorsi breast reconstruction and no patient-reported outcome measures designed specifically for the procedure. Methods A prospective cohort of breast cancer patients having latissimus dorsi reconstruction after a mastectomy was recruited from 270 hospitals in the United Kingdom. An 18-month follow up questionnaire containing two novel scales was sent to consenting patients. The prevalence of aesthetic and functional morbidity at the donor site was described. The two new scales were refined using the Rasch measurement model and subsequently validated. Results 1,096 women completed the new scales. 78% of patients reported that no back appearance issues had bothered them “most of the time” or “all of the time” in the past two weeks. The equivalent figure for functional morbidity was 60%. Four items were eliminated following initial psychometric testing. This produced an 8-item Back Appearance scale and an 11-item Back and Shoulder Function scale. Both scales showed adequate fit to the Rasch measurement model. Higher levels of aesthetic and functional bother were observed for completely autologous procedures versus those where latissimus dorsi reconstruction was used to cover an implant ( p  <   0.05). Higher levels of aesthetic bother were observed in women who had suffered a perioperative complication at the donor site ( p  = 0.003). Conclusion These results can inform patients of the morbidity associated with latissimus dorsi reconstruction. The new scales can be used to compare groups undergoing different variations of the procedure and to monitor individual patients. [ABSTRACT FROM AUTHOR]

Background Previous studies suggest that immediate reconstruction following mastectomy produces superior results over delayed procedures. However, for medical or oncological reasons, some patients may be poor candidates for immediate reconstruction. We compared complications and patient-reported outcomes between immediate and delayed breast reconstructions in a prospective, multicenter study. Methods 1957 patients (1806 immediate, 151 delayed) met eligibility criteria. Demographic data, major complications, infections, and reconstructive failure rates were evaluated. Patient-reported outcomes were assessed with BREAST-Q, PROMIS, and EORTC QLQ-BR23 surveys, pre- and two years post-operatively. Subscale scores were compared across cohorts using mixed-effects regression models, controlling for patient characteristics and hospitals. Findings Complete data were available in 1639 immediate and 147 delayed reconstruction patients. There were significant baseline differences between immediate and delayed cohorts in age, BMI, prevalence of diabetes, lymph node management, use of radiation, and chemotherapy. Controlling for clinical covariates, the delayed group had lower odds of any (OR 0.38, p < 0.001) and major (OR 0.52, p = 0.016) complications, compared with immediate patients. Furthermore, delayed reconstruction was associated with a significantly lower failure rates (6% vs. 1.3%, p = 0.032). However, multivariate analyses found no significant differences in patient satisfaction or in psychosocial, sexual, or physical well-being at two years. Conclusions Compared with immediate techniques, delayed reconstruction following mastectomy was associated with lower rates of overall and major complication, while providing equivalent patient satisfaction and quality of life benefits. Although immediate reconstruction is still the preferred choice of most patients and surgeons, delaying reconstruction does not appear to compromise clinical or patient-reported outcomes. [ABSTRACT FROM AUTHOR]

Background Chronic postsurgical pain (CPSP) is a reported risk for women undergoing breast reconstruction, but it remains unclear that such persistent pain is induced by reconstructive surgery. To address this concern, this prospective cohort study examined the prevalence of and risk factors associated with CPSP among women undergoing breast reconstruction. Materials and methods Women (n = 1996) recruited for the Mastectomy Reconstruction Outcomes Consortium (MROC) Study were assessed preoperatively and at two-years postoperatively for relevant medical/.surgical variables, pain experience, body physical well-being, anxiety, depression, and reconstruction procedure type and characteristics. Results Nearly half of the entire sample reported some level of preoperative pain. At two years there were statistically significant but not clinically meaningful increases in both pain intensity and chest/upper body discomfort but a decrease in affective pain rating. Average clinical pain severity was strikingly similar for preoperative and postoperative assessments. Preoperative levels of pain, acute postoperative pain, and (marginally) level of depression held consistent relationship at two-year follow-up with all outcome measures. Autologous flap reconstruction was associated with more severe CPSP compared to TE/I reconstruction. Older age, higher BMI, bilateral reconstruction, and adjuvant radiation and chemotherapy were associated with CPSP and chest/upper body discomfort for at least one outcome measure at two years. Conclusions The substantial rate of preoperative pain and comparable prevalence of preoperative and postoperative pain ratings suggest that persistent pain after breast reconstruction may not necessarily reflect surgery-induced pain. Future research will need to determine those factors that contribute to long-term pain following breast reconstruction. [ABSTRACT FROM AUTHOR]

Women undergoing surgery for primary breast cancer can choose between breast conserving therapy and mastectomy (with or without breast reconstruction). Patients often turn to outcomes data to help guide the decision-making process. The BREAST-Q is a validated breast surgery–specific patient-reported outcome measure that evaluates satisfaction, quality of life, and patient experience. It was originally developed for paper-and-pencil administration. However, the BREAST-Q has increasingly been administered electronically. Therefore, the aim of this study was to evaluate the psychometric properties of an electronic version of the BREAST-Q in a large online survey. Women with a history of breast cancer surgery recruited from the Love/AVON Army of Women program completed an electronic version of the BREAST-Q in addition to the Impact of Cancer Survey and PTSD Checklist. Traditional psychometric analyses were performed on the collected data. BREAST-Q data were collected from 6748 women (3497 Breast Conserving Therapy module, 1295 Mastectomy module, 1956 Breast Reconstruction module). Acceptability was supported by a high response rate (82%), low frequency of missing data (<5%), and maximum endorsement frequencies (<80%) in all but 17 items. Scale reliability was supported by high Cronbach's α coefficients (≥0.78) and item-total correlations (range of means, 0.65–0.91). Validity was supported by interscale correlations, convergent and divergent hypotheses as well as clinical hypotheses. The electronically administered BREAST-Q yields highly reliable, clinically meaningful data for use in clinical outcomes research. The BREAST-Q can be used in the clinical setting, whether administered electronically or using paper-and-pencil, at the choice of the patient and surgeon. [ABSTRACT FROM AUTHOR]

Abstract While sexual health is an important aspect of quality of life, sexual issues usually go unaddressed during patient-provider communication. Breast cancer treatments and specifically breast surgery impact women's sexual well-being. However, women do not receive adequate information on this subject. Women who underwent prophylactic mastectomy and breast reconstruction invariably reported that they had underestimated the impact of mastectomy and reconstruction on their sexuality, and expressed a need for information and creating realistic expectations pertaining to sexuality. Therefore, we urge breast surgeons to take the lead in addressing sexuality along with other health-related quality-of-life outcomes during pre-operative consultation. [ABSTRACT FROM AUTHOR]

Background: Surgery may have a profound effect on patients' health-related quality of life (QOL). To be optimally useful, trials that seek to guide clinical decision making should measure outcomes that are important to patients and report the results in a clinically meaningful way. We sought to explore how researchers currently measure and interpret QOL in surgical trials, using gastric cancer as a case study.Method: We performed a systematic review of randomized controlled trials (RCTs) of gastric cancer surgery published between 1966 and 2009 that included at least one patient-reported outcome (PRO). Investigators assessed trial eligibility and extracted data in duplicate using standardized forms, then resolved disagreements by consensus.Results: Our search identified 87 RCTs of gastric cancer surgery, of which 11 (13%) included at least one PRO. Ten RCTs measured one or more validated PROs, although six also included ad hoc measures. All manuscripts presented the results as raw scores and nine of the 11 trials identified a statistical difference between groups. All 11 manuscripts prominently reported the PRO results in the abstracts and conclusions, but only one discussed the clinical significance of the differences between groups.Conclusions: Most RCTs of gastric cancer surgery do not include measures of QOL and those that do suffer from important limitations. RCTs would be more useful to surgeons and patients if authors measured PROs and utilized existing approaches to present the results of PROs in ways that provide an intuitive sense of the magnitude of effects. [ABSTRACT FROM AUTHOR]

Procedural skills are integral to the practice of pediatric emergency medicine, but provider experience is limited by case rarity. Simulation-based medical education allows for the practice of rare procedures without compromising patient safety. Simulation-based procedural training improves provider confidence, knowledge, and performance, and may translate to better patient outcomes. However, optimal instructional designs for simulation-based training remain unclear, and educators have a plethora of didactic approaches and simulator characteristics to consider. This article reviews how simulation can be used for pediatric procedural skills training and maintenance, focusing on instructional design features, simulation modalities, and the use of simulation as an assessment tool in the era of competency-based medical education. [ABSTRACT FROM AUTHOR]

Summary Background Health outcomes research has gained considerable traction over the past decade as the medical community attempts to move beyond traditional outcome measures such as morbidity and mortality. Since its inception in 2009, the BREAST-Q has provided meaningful and reliable information regarding health-related quality of life (HRQOL) and patient satisfaction for use in both clinical practice and research. In this study, we review how researchers have used the BREAST-Q and how it has enhanced our understanding and practice of plastic and reconstructive breast surgery. Methods An electronic literature review was performed to identify publications that used the BREAST-Q to assess patient outcomes. Studies developing and/or validating the BREAST-Q or an alternate patient-reported outcome measure (PROM), review papers, conference abstracts, discussions, comments and/or responses to previously published papers, studies that modified a version of BREAST-Q, and studies not published in English were excluded. Results Our literature review yielded 214 unique articles, 49 of which met our inclusion criteria. Important trends and highlights were further examined. Discussion The BREAST-Q has provided important insights into breast surgery highlighted by literature concerning autologous reconstruction, implant type, fat grafting, and patient education. The BREAST-Q has increased the use of PROMs in breast surgery and provided numerous important insights in its brief existence. The increased interest in PROMs as well as the underutilized potential of the BREAST-Q should permit its continued use and ability to foster innovations and improve quality of care. [ABSTRACT FROM AUTHOR]

Decitabine is a hypomethylating agent that irreversibly inhibits DNA methyltransferase I, inducing leukemic differentiation and re-expression of epigenetically silenced putative tumor antigens. We assessed safety and efficacy of decitabine maintenance after allogeneic transplantation for acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Decitabine maintenance may help eradicate minimal residual disease, decrease the incidence of graft-versus-host disease (GVHD), and facilitate a graft-versus-leukemia effect by enhancing the effect of T regulatory lymphocytes. Patients with AML/MDS in complete remission (CR) after allotransplantation started decitabine between day +50 and +100. We investigated 4 decitabine doses in cohorts of 4 patients: 5, 7.5, 10, and 15 mg/m 2 /day × 5 days every 6 weeks, for a maximum 8 cycles. The maximum tolerated dose (MTD) was defined as the maximum dose at which ≤ 25% of people experience dose-limiting toxicities during the first cycle of treatment. Twenty-four patients were enrolled and 22 were evaluable. All 4 dose levels were completed and no MTD was reached. Overall, decitabine maintenance was well tolerated. Grade 3 and 4 hematological toxicities were experienced by 75% of patients, including all patients treated at the highest dose level. Nine patients completed all 8 cycles and 8 of them remain in CR. Nine patients died from relapse (n = 4), infectious complications (n = 3), and GVHD (n = 2). Most occurrences of acute GVHD were mild and resolved without interruption of treatment; 1 patient died of acute gut GVHD. Decitabine maintenance did not clearly impact the rate of chronic GVHD. Although there was a trend of increased FOXP3 expression, results were not statistically significant. In conclusion, decitabine maintenance is associated with acceptable toxicities when given in the post-allotransplantation setting. Although the MTD was not reached, the dose of 10 mg/m 2 for 5 days every 6 weeks appeared to be the optimal dose rather than 15 mg/m 2 , where most hematological toxicities occurred. [ABSTRACT FROM AUTHOR]

Summary Introduction During preoperative discussions with breast reconstruction patients, questions often arise about what to expect during the recovery period. However, there is a paucity of data elucidating post-breast reconstruction pain, fatigue, and physical morbidity. This information is important to patient and physician understanding of reconstructive choices and the postoperative recovery process. We sought to evaluate how recovery may vary for patients based on the timing and type of reconstruction. Materials and methods Patients were recruited as part of the Mastectomy Reconstruction Outcomes Consortium (MROC) study, which is a prospective, multicentered National Institute of Health (NIH)-funded study (1RO1CA152192). Here, patients completed the Numerical Pain Rating Scale (NPRS), McGill Pain Questionnaire, and Breast-Q preoperatively, at 1 week, and 3 months postoperatively. Pain, fatigue, and upper body morbidity were evaluated by the type and timing of reconstruction. Results A total of 2013 MROC study participants had completed a 3-month follow-up, and therefore they were included for the analysis. A total of 1583 (78.6%) and 1517 patients (75.3%) completed surveys at 1 week and 3 months, respectively, post reconstruction. Across all procedure groups, fatigue and physical well-being scores did not return to preoperative levels by 3 months. At 3 months, pain measured by the NPRS differed across procedure types ( P = 0.01), with tissue expander/implant (TE/I) having more pain than direct to implant ( P < 0.01). Similarly, at 3 months, chest and upper body physical morbidity, as measured by BREAST-Q, differed by procedure types ( P < 0.001), with generally less morbidity for autologous reconstruction as compared with TE/Is. Conclusions For all reconstructive procedure groups, patients did not fully recover at 3 months post surgery. In addition, postoperative pain and upper body physical morbidity vary significantly by reconstructive procedure with patients undergoing TE/I reporting the most distress. [ABSTRACT FROM AUTHOR]

To identify the most effective way for medical students to interact with a browser-based learning module on the symptoms and neurological underpinnings of stroke syndromes, this study manipulated the way in which subjects interacted with a graphical model of the brain and examined the impact of functional changes on learning outcomes. It was hypothesized that behavioral interactions that were behaviorally more engaging and which required deeper consideration of the model would result in heightened cognitive interaction and better learning than those whose manipulation required less deliberate behavioral and cognitive processing. One hundred forty four students were randomly assigned to four conditions whose model controls incorporated features that required different levels of behavioral and cognitive interaction: Movie (low behavioral/low cognitive, n = 40), Slider (high behavioral/low cognitive, n = 36), Click (low behavioral/high cognitive, n = 30), and Drag (high behavioral/high cognitive, n = 38). Analysis of Covariates (ANCOVA) showed that students who received the treatments associated with lower cognitive interactivity (Movie and Slider) performed better on a transfer task than those receiving the module associated with high cognitive interactivity (Click and Drag, partial eta squared = .03). In addition, the students in the high cognitive interactivity conditions spent significantly more time on the stroke locator activity than other conditions (partial eta squared = .36). The results suggest that interaction with controls that were tightly coupled with the model and whose manipulation required deliberate consideration of the model's features may have overtaxed subjects' cognitive resources. Cognitive effort that facilitated manipulation of content, though directed at the model, may have resulted in extraneous cognitive load, impeding subjects in recognizing the deeper, global relationships in the materials. Instructional designers must, therefore, keep in mind that the way in which functional affordances are integrated with the content can shape both behavioral and cognitive processing, and has significant cognitive load implications. [Copyright &y& Elsevier]

Abstract: The influence of pro-apoptotic Bax and anti-apoptotic Bcl-2 proteins on the cell death (caspase-3, TUNEL) of different ovarian cell lineages was immunohistochemically analyzed in six fetal and five adult human ovaries in order to disclose possible mechanisms of cell number control. Mild to moderate expression of Bcl-2 characterized ovarian surface epithelium, follicular cells and oocytes of 15 and 22 week human ovaries, while expression of Bax and caspase-3 gradually increased in all ovarian cell populations, except caspase-3 in the ovarian surface epithelium. Different levels of Bax and Bcl-2 proteins co-expression characterized fetal ovarian cells, while TUNEL and caspase-3 co-expression was found only in some of them. In adult ovaries, Bcl-2 was moderately and Bax strongly expressed in the surface ovarian epithelium and stroma. Bcl-2 and Bax expression in granulosa and theca interna cells varied depending on the stage of follicular atresia. Caspase-3 apoptotic cells characterized granulosa cells of adult atretic follicles. Our results indicate that intracellular levels of Bcl-2 and Bax protein might regulate the final destiny of developing germ cells. Caspase-3 dependent apoptosis seems to be the most important, but not the only cell death pathway in ovaries. In adult ovaries, caspase-dependent cell death characterized granulosa cells, but not the germ cells. [Copyright &y& Elsevier]

Summary: Objective: Cleft lip and/or palate (CLP) is the most common congenital craniofacial anomaly. As a first step toward developing a quality of life (QOL) questionnaire for CLP patients, our team conducted a systematic literature review to identify studies that measured child- or proxy-reported outcomes of CLP. Design: PUBMED, CINAHL, EMBASE and PsycINFO were searched from their inception to July 2010 to identify studies that measured health-related concepts in CLP patients. Abstract and title screening was performed by two screeners. Full texts of all potentially relevant papers were obtained and examined by two reviewers. We identified publications that measured health concepts and categorized them to form a preliminary conceptual framework of CLP QOL issues. Results: A total of 4594 publications were identified. Twenty-six studies met our inclusion criteria. Research involved CLP patients living in nine countries with sample sizes ranging from 23 to 661. Health concepts were measured using 29 different questionnaires. No patient-reported outcome (PRO) instrument measuring QOL concerns of CLP patients currently exists. CLP-specific health concepts measured to date were categorized into a preliminary conceptual QOL framework with the following categories: physical, psychological and social health. Conclusions: Our review has helped to identify areas of health that have been well researched using either a patient or proxy patient-reported outcome instrument (e.g., self-concept; behavior) and areas where more research is required. [ABSTRACT FROM AUTHOR]

Abstract: In this proof-of-concept study we report the use of <15nm, water soluble, inorganic nanoparticles as a vaccine delivery system for a blood stage malaria vaccine. The recombinant malarial antigen, Merozoite Surface Protein 1 (rMSP1) of Plasmodium falciparum served as the model vaccine. The rMSP1 was covalently conjugated to polymer-coated quantum dot CdSe/ZnS nanoparticles (QDs) via surface carboxyl groups, forming rMSP1-QDs. Anti-MSP1 antibody responses induced by rMSP1-QDs were found to have 2–3log higher titers than those obtained with rMSP1 administered with the conventional adjuvants, Montanide ISA51 and CFA. Moreover, the immune responsiveness and the induction of parasite inhibitory antibodies were significantly superior in mice injected with rMSP1-QDs. The rMSP1-QDs delivered via intra-peritoneal (i.p.), intra-muscular (i.m.), and subcutaneous (s.c.) routes were equally efficacious. The high level of immunogenicity exhibited by the rMSP1-QDs was achieved without further addition of other adjuvant components. Bone marrow derived dendritic cells were shown to efficiently take up the nanoparticles leading to their activation and the expression/secretion of key cytokines, suggesting that this may be a mode of action for the enhanced immunogenicity. This study provides promising results for the use of water soluble, inorganic nanoparticles (<15nm) as potent vehicles/platforms to enhance the immunogenicity of polypeptide antigens in adjuvant-free immunizations. [Copyright &y& Elsevier]

Summary: To review existing patient reported outcomes measures (PROMs) used in dysphonic populations to assess the procedures used in their development and the extent to which these meet current development standards for content generation and psychometric evaluation. The study is a systematic review. A systematic review of Medline, Cumulative Index to Nursing & Allied Health, and Health and Psychosocial Instruments databases was completed using voice, quality of life, and PROMs as keywords. We identified all patient or parent-reported questionnaires measuring quality of life associated with voice disorders from the review findings. Questionnaires were appraised for adherence to international guidelines for the development and evaluation of PROMs as outlined by the Scientific Advisory Committee of the Medical Outcome Trust. Nine PROMs fulfilled the inclusion criteria. The quality of these questionnaires was variable with regard to instrument development and none met all of the current, recommended criteria. Of the nine questionnaires, the Voice Symptom Scale underwent the most rigorous development process. Furthermore, many instruments have been augmented to allow for proxy administration, failing to address quality of life-related issues specific to the target population. Instrument development is often overlooked when attempting to quantify patient reported outcomes in dysphonic patients. Careful instrument development procedures are required to ensure that PROMs are valid, reliable, and responsive. Our review suggests that the deficits in psychometric properties of the current voice-related PROMs may be, at least in part, due to deficits in the development process. Furthermore, these data suggest the potential utility of a novel PROM adhering to rigorous international standards to better ensure that clinicians appreciate the variables most relevant to patients with voice disorders and address some of the psychometric shortcomings of the currently used questionnaires. [Copyright &y& Elsevier]

To review existing patient reported outcomes measures (PROMs) used in dysphonic populations to assess the procedures used in their development and the extent to which these meet current development standards for content generation and psychometric evaluation. The study is a systematic review. A systematic review of Medline, Cumulative Index to Nursing & Allied Health, and Health and Psychosocial Instruments databases was completed using voice, quality of life, and PROMs as keywords. We identified all patient or parent-reported questionnaires measuring quality of life associated with voice disorders from the review findings. Questionnaires were appraised for adherence to international guidelines for the development and evaluation of PROMs as outlined by the Scientific Advisory Committee of the Medical Outcome Trust. Nine PROMs fulfilled the inclusion criteria. The quality of these questionnaires was variable with regard to instrument development and none met all of the current, recommended criteria. Of the nine questionnaires, the Voice Symptom Scale underwent the most rigorous development process. Furthermore, many instruments have been augmented to allow for proxy administration, failing to address quality of life-related issues specific to the target population. Instrument development is often overlooked when attempting to quantify patient reported outcomes in dysphonic patients. Careful instrument development procedures are required to ensure that PROMs are valid, reliable, and responsive. Our review suggests that the deficits in psychometric properties of the current voice-related PROMs may be, at least in part, due to deficits in the development process. Furthermore, these data suggest the potential utility of a novel PROM adhering to rigorous international standards to better ensure that clinicians appreciate the variables most relevant to patients with voice disorders and address some of the psychometric shortcomings of the currently used questionnaires. [ABSTRACT FROM AUTHOR]

Abstract: The purpose of this article was to examine historic institutional autologous stem cell mobilization practices and evaluate factors influencing mobilization failure and kinetics. In this retrospective study we analyzed clinical records of 1834 patients who underwent stem cell mobilization for autologous transplantation from November 1995 to October 2006 at the Washington University in St. Louis. Successful mobilization was defined as collection of ≥2 × 106 CD34+ cells/kg. From 1834 consecutive patients, 1040 met our inclusion criteria (502 non-Hodgkin''s lymphoma [NHL], 137 Hodgkin''s lymphoma, and 401 multiple myeloma [MM]). A total of 976 patients received granulocyte colony-stimulating factor (G-CSF) and 64 received G-CSF plus chemotherapy (G/C) for the initial mobilization. Although the median CD34+ cell yield was higher in G/C group than in G-CSF alone group, the failure rates were similar: 18.8% and 18.6%, respectively. Overall, 53% of patients collected ≥2 × 106 CD34+ cells/kg during the first apheresis with either mobilization regimen. Regardless of mobilization regimen used, MM patients had the highest total CD34+ cell yield and required less aphereses to collect ≥2 × 106 CD34+ cells/kg. Mobilized, preapheresis, peripheral blood CD34+ count correlated with first day apheresis yield (r = .877, P < .001) and 20 cells/μL was the minimum threshold needed for a successful day 1 collection. For the remobilization analysis we included patients from the whole database. A total of 269 of 1834 patients underwent remobilization using G/C, G-CSF, and/or GM-CSF, and G-CSF plus plerixafor. Only 23% of remobilized patients achieved ≥2 × 106 CD34+ cells/kg and 29.7% failed to pool sufficient number of stem cells from both collections. Patients receiving G-CSF plus plerixafor had lowest failure rates, P = .03. NHL patients remobilized with G-CSF who waited ≥25 days before remobilization had lower CD34+ cell yield than those who waited ≤16 days, P = .023. Current mobilization regimens are associated with a substantial failure rate irrespective of underlying disease. Patients who fail initial mobilization are more likely to fail remobilization. These findings suggest that there is a need for more effective first-line mobilization agents. [Copyright &y& Elsevier]

Rationale and Objective: We sought to determine which is more effective in increasing skill in radiograph interpretation: a linear (PowerPoint-style) computer tutorial that locks the student into a fixed path through the material or a branched (Web-style) version that allows random access. Materials and Methods: We prepared a computer tutorial for learning how to interpret cervical spine radiographs. The tutorial has 66 screens including radiographs or graphics on almost every page and five unknown radiographs for the student to interpret. One version (linear) presents the material in a linear sequence with the unknown radiographs heading up "chapters" detailing an important aspect of the task. In the second (branched) version, the same 66 screens were accessed through hyperlinks in a frame beside the unknown radiographs. One hundred thirty-nine medical students at two sites participated in a randomized single-blinded controlled experiment. They interpreted cervical spine images as a pretest and then completed one of the two tutorial versions. Afterward, they did the same examination as a post-test. Results: The tutorial was successful, in both layouts, in improving the subjects' ability to interpret cervical spine radiograph images (effect size 2.1; 95% confidence interval 1.7-2.5). However, the layout did not make a difference to their gain in ability. Students in the linear group completed the tutorial in 17% less time (P < .001) but were slightly less likely to rate the tutorial as "valuable." Conclusion: For these novice learners, computer tutorial layout does not affect knowledge gain. Students may be more satisfied with the linear layout, but in time-pressured situations, the Web-style layout may be preferable because it is more efficient. [ABSTRACT FROM AUTHOR]

To the evaluate the readability and comprehensiveness of genitourinary and sexual health-related patient-reported outcomes (PROMs) used in gender-affirming care. Common PROMs that measure genitourinary and sexual health-related outcomes in gender-affirming care literature were identified from six recent systematic reviews. Readability analysis was completed at the level of individual items and full scale using established readability assessment tool, including Flesch Kincaid Grade Level (FKGL), Gunning Fog Score (GF), Coleman Liau Index (CLI), and Simple Measure of Gobbledygook (SMOG) Index. The concepts measured by the PROMs were evaluated for comprehensiveness. Twenty-five PROMs were included, of which 12 assessed genitourinary outcomes and 13 assessed sexual health outcomes. A total of seven genitourinary domains and eight sexual health domains were identified during concept mapping. Readability analysis showed a median PROM grade level of 9.0 and 9.5 in genitourinary and sexual PROMs, respectively. The Patient-Reported Outcomes Measurement Information System Sexual Function and Satisfaction v2.0 had the lowest median reading grade level of 5.7, and the Female Sexual Function Index has the highest median reading grade level of 13.9. No single PROM was found to be comprehensive. Multiple PROMs contained double-barreled items or used outdated terminology. Most PROMs used in the genital gender-affirming literature failed to meet the readability recommendations for patient-facing material and were culturally unfit for use in transgender and gender-diverse individuals. None of the PROMs were found to be comprehensive for evaluating outcomes of gender-affirming care. Validated gender-affirming care-specific PROMs that are comprehensible, comprehensive, and relevant are urgently needed. [ABSTRACT FROM AUTHOR]