Enhancing care for transgender and gender diverse survivors of intimate partner violence: an Ontario-wide survey examining health and social service providers' learning needs.

OBJECTIVES: To better understand healthcare and social/community service providers' learning needs associated with supporting transgender and gender diverse (trans) persons who have experienced intimate partner violence (IPV). SETTING: An online survey was distributed through the trans-LINK Network in Ontario, Canada. RESPONDENTS: 163 of 225 healthcare and social/community service providers completed the survey (72.4% response rate) between November 2022 and February 2023. MAIN OUTCOME MEASURES: Expertise, training, workplace practices and learning needs related to supporting trans survivors of IPV. METHOD: Quantitative survey results were analysed descriptively and open-ended responses were organised thematically. In March 2022, survey results were shared with 33 stakeholders who helped define goals and objectives for an e-learning curriculum using Jamboard, data from which were collated and organised into themes. RESULTS: Most (66.3%) survey respondents described having provided professional support to trans survivors of IPV, but only one-third (38.0%) reported having received relevant training, and many of the trainings cited were in fact focused on other forms of violence or trans health generally. The majority reported a mid (44.9%) or low-mid (28.5%) level of expertise and almost unanimously agreed that they would benefit from (further) training (99.4%). The most commonly recommended goal/objective for a curriculum emerging from the stakeholder consultation was to facilitate collaboration, knowledge sharing and (safe) referrals among organisations. CONCLUSIONS: The results of this study highlight the critical need for an IPV curriculum specific to trans survivors and responsive to the needs of providers. As no one profession can address this complex issue in isolation, it is important that the curriculum aims to facilitate collaboration across sectors. In the absence of appropriate training and referrals, practitioners may perpetuate harm when caring for trans survivors of IPV.

Bridging Gaps in Collaboration Between Community Organizations and Hospital-Based Violence Treatment Centers Serving Transgender Sexual Assault Survivors.

Community and healthcare organizations have not historically collaborated effectively, leaving gaps in the continuum of care for survivors of sexual assault. These gaps are particularly acutely felt by transgender (trans) survivors, who experience additional barriers to care and face higher rates of sexual assault. To bridge these gaps and enhance the provision of comprehensive support for trans people, we developed an intersectoral network of trans-positive community and hospital-based organizations in Ontario, Canada. As part of a baseline evaluation of the network, we conducted a social network analysis to determine the extent and nature of collaboration between members within and across these two sectors. Using a validated social network analysis tool (PARTNER survey), data were collected from June 22 to July 22, 2021. The extent of collaboration was examined by relationship type: intrasectoral (same sector) and intersectoral (different sectors). The nature of collaboration was examined using relational scores (value: power, level of involvement, potential resource contribution; trust: reliability, mission congruence, openness to discussion). Fifty-four community organizations (65.9% of 82 invited) and 24 hospital-based violence treatment centers (64.9% of 37 invited) responded. The majority of collaborations were within, rather than across, the two sectors: of all 378 collaborations described, 70.9% (n = 268) were intrasectoral collaborations and 29.1% (n = 110) were intersectoral collaborations. Intersectoral relationships were characterized by lower scores for level of involvement, trust, reliability, and mission congruence than intrasectoral relationships, but higher scores for power. These findings were shared in a virtual consultation session of key stakeholders, in which some participants expressed "surprise" and concern for the lack of collaboration and character of relationships across sectors. Recommendations to increase intersectoral collaboration, which included intersectoral program planning and service design and supporting increased opportunities for intersectoral training and knowledge exchange, are presented.

Cost impact analysis of enhanced recovery after minimally invasive gynecologic oncology surgery.

OBJECTIVE: The implementation of a peri-operative care program based on enhanced recovery after surgery principles for minimally invasive gynecologic oncology surgery led to an improvement in same day discharge from 29% to 75% at our center. This study aimed to determine the program's economic impact. METHODS: Our initial enhanced recovery quality improvement program enrolled consecutive patients undergoing minimally invasive hysterectomy at a single center during a 12-month period and compared them to a pre-intervention cohort. The primary outcome was overall costs. The secondary outcomes were surgical and post-operative visit costs. The surgical visit costs included pre-operative and operating room, post-operative stay, pharmacy, and interventions costs. The 30-day post-operative visit costs included clinic and emergency room, and readmission costs. The costs for every visit were collected from the case-cost department and expressed in 2020 Canadian dollars (CAD). RESULTS: A total of 96 and 101 patients were included in the pre- and post-intervention groups, respectively. The median total cost per patient for post-intervention was $7252 compared with $8381 pre-intervention (p=0.02), resulting in a $1129 cost reduction per patient. The total cost for the program implementation was $134 per patient for a total cost of $13 106. The median post-operative stay cost was $816 post-intervention compared with $1278 pre-intervention (p<0.05). Statistically significant savings for the post-intervention group were also found for operative visit, operating room costs, and pharmacy (p<0.05). On multivariate analysis, surgical approach was the only factor associated with operating room costs, whereas both surgical approach and group (pre- vs post-intervention) impacted the total and post-operative stay costs (p<0.05). CONCLUSION: In addition to increasing the same day discharge rate after minimally invasive gynecologic oncology surgery, an enhanced recovery-based peri-operative care program led to significant reductions in cost.

Recommendations to Improve the Nature and Extent of Relationships Among Organizations Within a Network to Enhance Supports for Transgender Survivors of Sexual Assault.

CONTEXT: To enhance the provision of comprehensive supports to transgender (trans) survivors of sexual assault, a structurally marginalized group with complex care needs, we developed an intersectoral network of trans-positive health care and community organizations in Ontario, Canada. OBJECTIVE: As a baseline evaluation of the network, we conducted a social network analysis to determine the extent and nature of collaboration, communication, and connection among members. DESIGN: Relational data (eg, activities of collaboration) were collected from June to July 2021, and analyzed using a validated survey tool, Program to Analyze, Record, and Track Networks to Enhance Relationships (PARTNER). We shared findings in a virtual consultation session with key stakeholders and facilitated discussion to generate action items. Consultation data were synthesized into 12 themes through conventional content analysis. SETTING: An intersectoral network in Ontario, Canada. PARTICIPANTS: Of the 119 representatives of trans-positive health care and community organizations invited to participate in this study, 78 (65.5%) completed the survey. MAIN OUTCOME MEASURES: Proportion/count of organizations collaborating with other organizations. Network scores for value and trust. RESULTS: Almost all (97.5%) invited organizations were listed as collaborators, representing 378 unique relationships. The network achieved a value score of 70.4% and trust score of 83.4%. The most prominent themes were "Communication and knowledge exchange channels," "Clearer roles and contributions," "Indicators of success," and "Client voices at the centre." CONCLUSION: As key antecedents of network success, high value and trust indicate that network member organizations are well positioned to further foster knowledge sharing, define their roles and contributions, prioritize the integration of trans voices in all activities, and, ultimately, achieve common goals with clearly defined outcomes. There is great potential to optimize network functioning and advance the network's mission to improve services for trans survivors by mobilizing these findings into recommendations.

Advancing community-engaged research during the COVID-19 pandemic: Insights from a social network analysis of the trans-LINK Network.

Collaboration across sectors is critical to address complex health problems, particularly during the current COVID-19 pandemic. We examined the ability to collaborate during the pandemic as part of a baseline evaluation of an intersectoral network of healthcare and community organizations established to improve the collective response to transgender (trans) persons who have been sexually assaulted (the trans-LINK Network). A validated social network analysis survey was sent to 119 member organizations in Ontario, Canada. Survey respondents were asked, 'Has COVID-19 negatively affected your organization's ability to collaborate with other organizations on the support of trans survivors of sexual assault?' and 'How has COVID-19 negatively affected your organization's ability to collaborate within the trans-LINK Network?'. Data were analyzed using descriptive statistics. Seventy-eight member organizations participated in the survey (response rate = 66%). Most organizations (79%) indicated that the pandemic had affected their ability to collaborate with others in the network, citing most commonly, increased workload (77%), increased demand for services (57%), and technical and digital challenges (50%). Survey findings were shared in a stakeholder consultation with 22 representatives of 21 network member organizations. Stakeholders provided suggestions to prevent and address the challenges, barriers, and disruptions in serving trans survivors experienced during the pandemic, which were organized into themes. Seven themes were generated and used as a scaffold for the development of recommendations to advance the network, including: increase communication and knowledge exchange among member organizations through the establishment of a network discussion forum and capacity building group workshops; enhance awareness of network organizations by developing a member-facing directory of member services, their contributions, and ability to provide specific supports; strengthen capacity to provide virtual and in-person services and programs through enhanced IT support and increased opportunities for knowledge sharing and skill development; and adopt a network wide syndemic approach that addresses co-occurring epidemics (COVID-19 + racism, housing insecurity, transphobia, xenophobia) that impact trans survivors of sexual assault.

Development of a WebPortal to Advance and Mobilize Knowledge Relevant to Trans-Affirming Care for Sexual Assault Survivors in Ontario, Canada.

Transgender persons experience high rates of sexual assault and often encounter providers who lack the knowledge to deliver appropriate postassault care and supports. To build capacity within health care and social service organizations supporting trans survivors of sexual assault across Ontario, Canada, we undertook a study to inform the development of a WebPortal intended to provide freely accessible resources relevant to the provision of trans-affirming care. In this survey, 70 representatives from community and health care organizations indicated their overall dissatisfaction with the information currently available on the care and support of trans survivors and identified a need for improved access to a range of resources.

Formation of an intersectoral network to support trans survivors of sexual assault: A survey of health and community organizations.

BACKGROUND: To address the growing international recognition of the inequities faced by transgender (trans) persons and the lack of services that attend to the specific concerns of trans sexual assault survivors, we undertook the development of an intersectoral network of hospital-based violence treatment centers and trans-positive community organizations to enhance available supports. AIMS: To examine anticipated involvement of organizations in the network and determine network activities, deliverables, and values. METHODS: We developed a survey with guidance from an advisory group of trans community members and their allies. Items on the survey related to network activities, deliverables, and values, which were also informed by key insights from earlier network planning meetings, were rated on a 5-point Likert scale for their importance (1 = not important at all, 5 = very important). RESULTS: Sixty-four out of 93 organizations invited responded to the survey, giving a response rate of 69%. The highest prioritized network activities were: improve access to support services for trans survivors, educate trans survivors on their rights/what to expect when seeking supports and information on organizations, provide ongoing education/training for service providers on trans-affirming care, and inform guidelines on appropriate and sensitive standards of care/better practices for trans survivors (means = 4.6). The highest prioritized deliverables were: provision of standardized sensitivity training on violence against trans persons for professionals and development of an online directory/resource list of trans-affirming service providers and organizations that is continuously updated (means = 4.5). Trauma- and violence-informed and trans-guided were the most highly rated values (means = 4.8). CONCLUSION: These findings have implications for healthcare and community leaders seeking to collaborate across sectors to address the inequities faced by trans persons experiencing sexual assault.

Evaluation of an e-Learning Curriculum for Forensic Nurses on Trans-Affirming Postsexual Assault Care.

Trans survivors of sexual assault have called for the development and implementation of training for care providers. To answer this call, we developed and evaluated an innovative e-learning curriculum for forensic nurses working across Ontario, Canada, on the provision of trans-affirming care. The e-learning curriculum, developed in Storyline 360 by Articulate, was launched in August 2019. The competence of nurses (N=65) completing the curriculum improved significantly from pre- to post-training across all content domains (Initial assessment, Medical care, Forensic examination, and Discharge and referral). This e-learning curriculum could be of utility in training forensic nurses worldwide.

More pilot trials could plan to use qualitative data: a meta-epidemiological study.

BACKGROUND: Pilot trials often use quantitative data such as recruitment rate and retention rate to inform the design and feasibility of a larger trial. However, qualitative data such as patient, healthcare provider, and research staff perceptions of an intervention may also provide insights for a larger trial. METHODS: As part of a larger study investigating the reporting of progression criteria in pilot studies, we sought to determine how often pilot studies planned to use qualitative data to inform the design and feasibility of a larger trial and the factors associated with plans to use qualitative data. We searched for protocols of pilot studies of randomized trials in PubMed between 2013 and 2017. RESULTS: We included 227 articles. Only 92 (40.5%; 95% confidence interval [CI] 34.1-47.2) reported plans to collect qualitative data. The factors associated with collecting qualitative data were large studies (defined as sample size ≥ 60; adjusted odds ratio [aOR] 2.77; 95% CI 1.47-5.23; p = 0.002) and studies from Europe (aOR 3.86; 95% CI 1.68-8.88; p = 0.001) compared to North America and the rest of the world. Pilot trials with pharmacological interventions were less likely to plan to collect qualitative data (aOR 0.20; 95% CI 0.07-0.58; p = 0.003). CONCLUSIONS: Qualitative data is not used enough in pilot trials. Large pilot trials, pilot trials from Europe, and pilot trials of non-pharmacological interventions are more likely to plan for qualitative data.

The promise of an intersectoral network in enhancing the response to transgender survivors of sexual assault.

OBJECTIVES: This study explores the promise of an intersectoral network in enhancing the response to transgender (trans) survivors of sexual assault. METHODS: One hundred and three representatives of healthcare and community organizations across Ontario, Canada were invited to participate in a survey. Respondents were asked to: 1) identify systemic challenges to supporting trans survivors, 2) determine barriers to collaborating across sectors, and 3) indicate how an intersectoral network might address these challenges and barriers. Descriptive statistics were used to summarize quantitative data and qualitative data were collated thematically. RESULTS: Sixty-seven representatives responded to the survey, for a response rate of 65%. Several themes capturing the challenges organizations face in supporting trans survivors were identified: Lack of knowledge and training among providers, Inadequate resources across organizations and institutions, and Limited access to and availability of appropriate services. Barriers to collaborating across sectors considered important by the overwhelming majority of respondents were: Lack of trans-positive service professionals (e.g., a paucity of sensitivity training), lack of resources (e.g., staff, staff time and workload, spaces to meet), and Institutional structures (e.g., oppressive policies, funding mandates). Four ways in which a network could address these challenges and barriers emerged from the data: Center the voices of trans communities in advocacy; Support competence of professionals to provide trans-affirming care; Provide the platform, strategies, and tools to aid in organizational change; and Create space for organizations to share ideas, goals, and resources. CONCLUSION: Our findings deepen our understanding of important impediments to enhancing the response to trans survivors of sexual assault and the role networks of healthcare and community organizations can play in comprehensively responding to complex health and social problems.

Development and Evaluation of an Elder Abuse Forensic Nurse Examiner e-Learning Curriculum.

In Ontario, Canada, there is a need for an easily accessible training for forensic nurse examiners on the provision of care for abused older adults. In this study, our objective was to develop and evaluate a novel elder abuse nurse examiner e-learning curriculum focused on improving the care provided to older adults. The curriculum was launched on an online learning management system to forensic nurses working across Ontario's hospital-based violence treatment centers in June 2019 and evaluated using pre- and post-training questionnaires that measured self-assessed changes in knowledge and skills-based competence related to providing elder abuse care. There were significant improvements pre- to post-training in self-reported knowledge and competence across all core content domains: Older Adults and Abuse; Documentation, Legal, and Legislative Issues; Interview with Older Adult, Caregiver, and Other Relevant Contacts; Initial Assessment; Medical and Forensic Examination; and Case Summary, Discharge Plan, and Follow-Up Care. As the curriculum enhanced the knowledge and skills associated with caring for abused older adults, it may have implications for training forensic nurse examiners and associated staff working in more than 25 countries internationally.

Providing trans-affirming care for sexual assault survivors: An evaluation of a novel curriculum for forensic nurses.

BACKGROUND: Transgender (trans) persons experience high rates of sexual victimization, often face discrimination by healthcare providers, and may have unique and diverse needs post-victimization. However, there remains a lack of comprehensive trans-specific training among healthcare professionals, including nurses. OBJECTIVES: Our primary objective was to develop and evaluate a novel curriculum for its efficacy in improving the competence of forensic nurses in providing sensitive, informed, and appropriate healthcare services for trans survivors of sexual assault. METHODS: The curriculum was evaluated among forensic nurses working in sexual assault treatment centres across Ontario, Canada. Forty-seven nurses participated in this study, all of whom were selected by their respective programs to receive in-depth formal Sexual Assault Nurse Examiner training. Changes in participants' perceived expertise and competence in providing trans-affirming care were assessed on a 5-point Likert scale (5 being the highest level) using pre- and post-training questionnaires. Participants were asked to indicate their level of agreement with 31 competency-based statements, which were organized thematically into four domains: Initial Assessment, Medical Care, Forensic Examination, and Discharge and Referral. A clinical vignette assessed participants' demonstrated competence in providing care across four questions. RESULTS: Participants level of expertise improved significantly from pre- to post-training (Mean [M] = 1.89, Standard Deviation [SD] = 0.84 vs. M = 3.47, SD = 0.62, p< 001), as well as their competence across all content domains: initial assessment (M = 3.79, SD = 0.63 vs. M = 4.70, SD = 0.31, p < .001), medical care (M = 3.33, SD = 0.73 vs. M = 4.69, SD = 0.33, p < .001), forensic examination (M = 3.40, SD = 0.75 vs. M = 4.72, SD = 0.35, p < .001), and discharge and referral (M = 3.62, SD = 0.80 vs. M = 4.59, SD = 0.40, p < .001). There were also significant improvements in competence associated with the clinical vignette pre- to post- training (M score = 2.13, SD = 1.06 vs. M score = 3.23, SD = 0.87, p < .001). CONCLUSIONS: The success of this curriculum may have relevance to the more than 5000 members of the International Association of Forensic Nurses who practice and support forensic nursing across the globe, as well as to other healthcare professionals.

The reporting of progression criteria in protocols of pilot trials designed to assess the feasibility of main trials is insufficient: a meta-epidemiological study.

INTRODUCTION: Pilot and feasibility trials are conducted to determine feasibility or to collect information that would inform the design of a larger definitive trial. Clear progression criteria are required to determine if a definitive or main trial is feasible and how it should be designed. We sought to determine how often progression criteria are reported and the associated factors. METHODS: We conducted a methodological review of protocols for pilot randomised trials published in three journals that publish research protocols (BMJ Open, Trials, Pilot and Feasibility Studies), using a PubMed search (2013-2017). We extracted bibliometric information including the country in which the study was conducted, source of funding, type of intervention, use of a primary feasibility outcome, sample size reporting, and justification. We used generalised linear models to determine the factors associated with reporting progression criteria. RESULTS: Our search retrieved 276 articles, of which 49 were not eligible. We included 227 articles. Overall, 45/227 (19.8%; 95% confidence interval [CI] 14.8-25.6) reported progression criteria. Protocols published in more recent years were significantly associated with higher odds of reporting progression criteria (adjusted odds ratio [aOR] 1.40; 95% CI 1.03-1.92; p = 0.034). Pilot trials from Europe (aOR 0.19; 95% CI 0.08-0.48; p < 0.001) and the rest of the world (aOR 0.05; 95% CI 0.01-0.18; p < 0.003) compared to North America were significantly associated with lower odds of reporting progression criteria. Journal, source of funding, sample size, intervention type, and having a primary outcome related to feasibility were not significantly associated with reporting progression criteria. CONCLUSION: Progression criteria are not often explicitly stated in protocols of pilot trials leaving room for varied interpretation of findings. The development of formal guidance for progression criteria in protocols of pilot trials is warranted.

Assessment of nurses' competence to care for sexually assaulted trans persons: a survey of Ontario's Sexual Assault/Domestic Violence Treatment Centres.

OBJECTIVE: Our primary objective was to examine the perceived level of competence and need for additional training among nurses engaged in the care of sexually assaulted trans persons. Among these nurses, a secondary objective was to examine the impact of prior trans-specific training on their perceived level of competence. SETTING: An online survey was distributed to nurses working within 35 hospital-based violence treatment centres in Ontario, Canada. RESPONDENTS: 95 nurses completed the survey. PRIMARY AND SECONDARY OUTCOME MEASURES: The perceived level of competence and need for additional training overall and on 31 specific items associated with initial assessment, medical care, forensic examination and discharge and referral, as well as sociodemographic, work experience and prior training information, was collected and summarised using descriptive and inferential statistics. RESULTS: Almost three-quarters (73.1%) of nurses indicated that they had little or no expertise in caring for trans clients who have been sexually assaulted and 95.7% strongly agreed/agreed that they would benefit from (additional) training. The mean level of competence was 4.00 or greater (strongly agreed/agreed with the statement) for just 9 out of the 31 competencies related to caring for trans clients. Having undergone prior trans-specific training (61.3%) was associated with greater perceived competence in initial assessment (p=0.004) and medical care (p<0.001). CONCLUSION: It is of key importance that nurses demonstrate knowledge of and respond competently to the complex and diverse needs of trans survivors of sexual assault. The nurses surveyed overwhelmingly identified a need for additional training to care for sexually assaulted trans clients. It appears that additional training would be beneficial, as prior trans-specific training was associated with higher perceived competence in delivering certain aspects of care.

Reporting quality of pilot clinical trials in chronic kidney disease patients on hemodialysis: a methodological survey.

BACKGROUND: The conduct of high-quality pilot studies can help inform the success of larger clinical trials. Guidelines have been recently developed for the reporting of pilot trials. OBJECTIVE: This methodological survey evaluates the completeness of reporting in pilot randomized controlled trials in chronic kidney disease patients on hemodialysis (HD patients) and explores factors associated with better completion of reporting. METHODS: The authors searched Pubmed on July 1, 2018, for all pilot trials conducted in HD patients. Reporting quality was assessed against the 40-item Consolidated Standards of Reporting Trials (CONSORT) Extension for Pilot Trials. Study factors including year and country of publication, intervention, number of centers, type of funding, and journal endorsement of CONSORT were also examined. RESULTS: The mean number of items reported from the CONSORT extension for pilot trials across all included articles was 18.4 (standard deviation [SD] = 4.4). In the adjusted analysis, studies reported in later years (IRR = 1.026, 95% CI [1.018, 1.034], p < 0.001) and an increase of 20 persons in sample size (adjusted IRR = 1.021, 95% CI [1.010, 1.031], p < 0.001) were associated with a significantly higher number of CONSORT pilot items reported. CONCLUSIONS: Current reporting completeness of pilot trials in HD patients is suboptimal. Endorsing the CONSORT extension specific to pilot and feasibility studies and ensuring that pilot trials focus on the feasibility objectives may improve reporting completeness of these trials.

Nutritional Mobile Applications for CKD Patients: Systematic Review.

INTRODUCTION: Mobile health applications offer the potential to help people living with chronic kidney disease (CKD) manage diet-related challenges. This systematic review examined CKD dietary mobile app interventions; specifically, app characteristics, feasibility, and effectiveness in changing user behavior, as well as user satisfaction. METHODS: This review was reported in accordance with PRISMA guidelines. We searched scholarly databases, as well as the gray literature, for all randomized controlled trials, observational studies, needs assessments, and pilot testing/studies/trials focused on the development or evaluation of CKD dietary mobile app interventions. The characteristics, user satisfaction with, usability/feasibility, and effectiveness in changing dietary behavior of the mobile application were summarized using descriptive statistics and in a narrative manner. RESULTS: Thirteen full-text studies were included, of which 11 were single center, with a mean sample size of 23. Of the 7 studies that measured usability/feasibility, all found at least some aspects of the application feasible/useful. Of the 5 studies that reported an evaluation of changes in behavior/diet related to self-management, all reported some positive change. CONCLUSION: According to current studies, nutritional apps show promise in CKD self-management.

Development and evaluation of sexual assault training for emergency department staff in Ontario, Canada.

OBJECTIVE: The purpose of this evaluation was to assess the efficacy of a training in improving competence to address sexual assault among Emergency Department (ED) staff, as well as to compare in-person and online training modalities. METHODS: A total of 1564 staff from 76 EDs in acute care hospitals across Ontario participated in either on-site (n = 828 staff) or online (n = 736 staff) training sessions, of whom 1366 (87%) completed both a pre- and post-training questionnaire. Mean pre- and post-training scores measuring perceived competence in responding to victims/survivors of sexual assault were compared using paired t-tests. The mean gain score for in-person and online training was then compared using the Mann-Whitney U test. Finally, in-person and online participants' ratings of the training content and delivery were compared using the Mann-Whitney U test. RESULTS: There were significant improvements for all 16 self-reported measures of competence following training. The mean gain in knowledge and skills was higher for in-person training participants. Participants in the in-person modality more strongly agreed that the information they learned would help in providing care for sexual assault victims/survivors, and were more satisfied with the training overall. However, these participants less strongly agreed that there was an appropriate amount of time allotted for the scope of material presented. CONCLUSIONS: Overall, the training led to immediate improvements in ED staff perceived understanding and ability to address the needs of victims/survivors of sexual assault, with particular advantages to the in-person training.

Predicting tissue plasminogen activator use and success in in-center hemodialysis patients.

INTRODUCTION: Hemodialysis catheter malfunction is problematic. We aimed to determine clinical, catheter, and hemodialysis variables that predict: (i) catheter malfunction requiring recombinant tissue-plasminogen activator (TPA) treatment and (ii) the success of TPA administration. METHODS: Clinical, catheter, and hemodialysis variables were collected from a cohort of 559 catheters (141,526 catheter days) in 175 hemodialysis patients (2008-2011). Time to, and predictors of, catheter malfunction were determined for all catheters and primary catheters only, analyzed by Cox-proportional hazard model, multi-variable logistic regression model, and mixed-effect logistic regression models. Success of TPA use was determined immediately, next day, and two weeks after use. RESULTS: Shorter time to first TPA administration in all patient's catheters was associated with increased body mass index (hazard ratio [HR] = 1.06, 1.01-1.11, p = 0.03) and being of black race (HR = 3.05, 1.65-5.67, p<0.01). Primary TPA administration success at two weeks among primary catheters was associated with increased mean peak venous pressure before TPA administration (odds ratio [OR] = 1.03, 1.01-1.06, p<0.01) and decreased mean of the lowest systolic blood pressure measure for the three dialysis sessions prior to TPA administration (OR = 0.95, 0.91-0.99, p = 0.02). TPA administration success at two weeks among all catheters was associated with decreasing body mass index (OR = 0.84, CI 0.73-0.96, p = 0.01) and having diabetes (OR = 7.19, 1.40-36.81, p = 0.02). CONCLUSIONS: Both patient and dialysis predictors of TPA use and success were identified in this study, which may be useful for fine-tuning catheter management protocols to target hemodialysis patients at high risk of catheter malfunction.

Agreement in reporting between trial publications and current clinical trial registry in high impact journals: A methodological review.

OBJECTIVES: The primary objective of this systematic survey was to examine the percentage of studies in which there was agreement in the reporting of the primary outcome between the currently updated version of the clinical trial registry and the published paper. We also investigated the factors associated with agreement in reporting of the primary outcome. METHODS: We searched PubMed for all randomized control trials (RCT)s published in 2012-2015 in the top five general medicine journals (based on the 2014 impact factor). Two hundred abstracts (50 from each year) were randomly selected for data extraction. Agreement in reporting of 11 key study conduct items (e.g., sample size) and study characteristics (e.g., funding, number of sites) were extracted by two independent reviewers. ANALYSIS: Descriptive analyses were conducted to determine the proportion of studies on which there was agreement in reporting of key study conduct items. Generalized estimating equations were used to explore factors associated with agreement in reporting of the primary outcome. RESULTS: Of the 200 included studies, 87% had agreement in reporting of the primary outcome. After adjusting for other covariates, having greater than 50 sites was associated with an increased likelihood of agreement in reporting of the primary outcome (odds ratio=7.1, 95% confidence interval=1.39, 36.27, p=0.018). CONCLUSIONS: We identified substantive disagreement in reporting between publications and current clinical trial registry, which were associated with several study characteristics. Further measures are needed to improve reporting given the potential threats to the quality and integrity of scientific research.

Measuring patient satisfaction with vascular access: vascular access questionnaire development and reliability testing.

PURPOSE: The primary objective of this study is to measure hemodialysis patients' satisfaction with their vascular access. The secondary objective is to evaluate the measurement tool's psychometric properties to assess patient satisfaction with their vascular access. METHODS: We generated a comprehensive list of survey items related to patients' views and satisfaction with their vascular access and administered it to participating in-center hemodialysis patients over 4 months. Following a factor analysis, the items were reduced and rescaled to generate the final short-form vascular access questionnaire (SF-VAQ). The SF-VAQ was then administered to a new cohort of hemodialysis patients on two occasions 1 week apart from February 1, 2012, to April 1, 2014. A repeated measures analysis of variance and psychometric evaluation was conducted. RESULTS: The final SF-VAQ with 13 items and four domains was administered to 132 patients (35 fistulas, 14 grafts and 83 catheters). The mean Likert value for overall satisfaction on a scale of 1 (low) to 7 (high) was 5.98, with catheters, fistulas and grafts with values of 5.92, 6.46 and 5.21, respectively. The test-retest reliability for two occasions is 0.92 and the internal consistency for the first administration is high at 0.84. CONCLUSIONS: The SF-VAQ is a short, simple to administer vascular access-specific questionnaire with robust psychometric properties that can be used to obtain the patient's views on their vascular access. Based on the newly developed SF-VAQ, patients were the most satisfied with fistulas, scores.