"It's a Little Bit Tricky": Results from the POLYamorous Childbearing and Birth Experiences Study (POLYBABES).

The number of polyamorous people in Canada is growing steadily, and many polyamorous people are of childbearing age and report living with children. Experiences of polyamorous families, particularly those related to pregnancy and childbirth, have thus far been underrepresented in the literature. The POLYamorous Childbearing and Birth Experiences Study (POLYBABES) sought to explore the pregnancy and birth experiences of polyamorous people. Having previously reported findings relating to experiences with the health system and healthcare providers, this article specifically focuses on the social aspects of polyamorous families' experiences. We explored the impact of polyamory on one's self identity, relationship structures, and experiences navigating the social world. Anyone who self-identified as polyamorous during pregnancy and birth, gave birth in Canada within 5 years, and received some prenatal care was eligible to participate in this study. Participants were recruited through social media and interviewed online or in person. Twenty-four participants were interviewed (11 birthing people and 13 of their partners). Thematic analysis was used to explore the data, and four primary themes were identified: deliberately planning families, more is more, presenting polyamory, and living in a mononormative world. Each theme was further broken down into a number of sub-themes. We also collaborated with research participants to create a glossary of terms. By exploring the pregnancy and birth experiences of polyamorous families and focusing on participant voices, this research adds to the limited research on polyamorous families and contributes to the process of breaking down stigma associated with alternative family structures. Further, by creating an accessible glossary of terms, researchers and lay persons alike have been given access to a meaningful resource.

Research Consent Models Used in Prospective Studies of Neurologically Deceased Organ Donors: A Systematic Review.

Research to inform the care of neurologically deceased organ donors is complicated by a lack of standards for research consent. In this systematic review, we aim to describe current practices of soliciting consent for participation in prospective studies of neurologically deceased donors, including the frequency and justification for these various models of consent. Among the 74 studies included, 14 did not report on any regulatory review, and 13 did not report on the study consent procedures. Of the remaining 47 studies, 24 utilized a waiver of research consent. The most common justification for a waiver of research consent related to the fact that neurologically deceased donors are not considered human subjects. In conclusion, among studies of neurologically deceased donors, research consent models vary and are inconsistently reported. Consensus and standardization in the application of research consent models will help to advance this emerging field of research.

The Polyamorous Childbearing and Birth Experiences Study (POLYBABES): a qualitative study of the health care experiences of polyamorous families during pregnancy and birth.

BACKGROUND: As many as 1 in 5 adults practise some type of consensual nonmonogamy such as polyamory; many are married, have children, or both. Polyamorous families face unique challenges when accessing care during pregnancy and birth, and qualitative descriptive studies are needed to understand their experiences and inform health care providers' practice. METHODS: Participants, who self-identified as polyamorous, had given birth in the last 5 years and received at least some prenatal care, were recruited through convenience sampling on social media. Any of the birthing individual's partners were also invited to participate. All participants completed a short demographic questionnaire and participated in a semistructured interview. Interview transcripts were coded using Braun and Clarke's iterative thematic analysis. RESULTS: A total of 24 participants, 11 who had given birth and 13 partners, were interviewed. Of those who had given birth, 5 received midwifery care only, 4 received obstetric care exclusively and 2 received shared care. Polyamorous families described sharing many common experiences during pregnancy and birth that were affected by their polyamorous identity. Although participants reported both positive and negative experiences with health care providers, when accessing health care all had experienced some form of marginalization that was related to their polyamorous status. One particular challenge for families was with respect to disclosure of polyamorous identity in hospital environments. Participants offered suggestions for improving the health care of polyamorous families during pregnancy and birth, including creating nonjudgmental spaces, accommodating difference through minimizing administrative barriers and allying with patients by providing patient-led care. INTERPRETATION: Polyamorous families face marginalization when accessing pregnancy and birth care. Care experiences for polyamorous families can be improved by nonjudgmental, open attitudes of health care providers, and modifications to hospital policies to support multiparent families.

A mixed-methods study of organ donation in the intensive care unit: 22 actionable practices to improve organ donation.

PURPOSE: Rates of organ donation vary between otherwise comparable intensive care units (ICUs) suggesting that the process of donation must vary between ICUs. The purpose of this study was to describe the process of organ donation from the perspective of ICU staff, identify important drivers of successful donation, and develop strategies to improve the process of donation. METHODS: We conducted qualitative interviews with 32 ICU staff, including physicians, nurses, and respiratory therapists, using an interview guide developed from previous studies on organ donation. Using a qualitative descriptive approach, we coded interviews using qualitative content analysis. We integrated findings from the interviews in a mixed-methods analysis with previously published data from a document analysis and cross-sectional survey to identify practices that may enhance organ donation in the ICU. RESULTS: Five major themes important to the organ donation process emerged from the interviews: i) staff relationship with organ donation coordinators; ii) standardized processes; iii) ICU staff beliefs; iv) integration of donation and high quality end-of-life care; v) feedback and staff support. In the mixed-methods analysis, we identified 22 actionable practices to enhance the process of organ donation in the ICU. CONCLUSION: Incorporating the perspectives of ICU staff, we were able to identify 22 practice changes that may have a significant cumulative impact on donation outcomes. Future research is required to evaluate whether these findings account for the variability of donation rates between otherwise comparable ICUs.

Hamilton-DONATE: a city-wide pilot observational study of the ICU management of deceased organ donors.

PURPOSE: Improving the medical care of deceased organ donors to increase transplant rates and improve allograft function requires an understanding of the current epidemiology and clinical practices of deceased donation within intensive care units (ICUs). Herein, we report the results of our investigation into the feasibility of a multicentre prospective cohort study addressing the afformentioned issues. METHODS: We conducted a 12-month prospective observational cohort study in six ICUs and one coronary care unit in Hamilton, Canada. We included consecutive children and adults following consent for deceased organ donation (including neurologic determination of death [NDD] or donation after circulatory death [DCD]). Intensive care unit research staff recorded donor management data from hospital records, extending from one day prior to the consent for organ donation up to the time of organ retrieval. The provincial Organ Donation Organization (ODO) supplemented these data and, additionally, provided data on corresponding organ recipients. We identified, evaluated, and measured three potential obstacles to the feasibility of a national cohort study: obtaining authorization to implement the study with a waiver of research consent, accessibility of transplant recipient data, and the time required to complete very detailed case report forms (CRFs), with valuable lessons learned for implementation in future projects. RESULTS: The local Research Ethics Board and the ODO Privacy Office both authorized the recording of donor and recipient study data with a waiver of research consent. Sixty-seven consecutive consented donors were included (31 NDD and 36 DCD donors); 50 of them provided 144 organs for transplantation to 141 recipients. We identified the age and sex of the recipients as well as the location and date of transplant for all organ recipients in Ontario; however, we obtained no recipient data for six organs transported outside of Ontario. Intensive care unit research staff estimated that future CRF completion will require five to seven hours per patient. CONCLUSION: The Hamilton-DONATE pilot study supports the feasibility of a larger cohort study to describe the epidemiology and clinical practices related to deceased donor care in Canada. TRIAL REGISTRATION: wwwclinicaltrials.gov (NCT02902783). Registered 16 September 2016.

Organ donation in the ICU: A document analysis of institutional policies, protocols, and order sets.

OBJECTIVE: To better understand how local policies influence organ donation rates. RESEARCH METHODOLOGY/DESIGN: We conducted a document analysis of our ICU organ donation policies, protocols and order sets. We used a systematic search of our institution's policy library to identify documents related to organ donation. We used Mindnode software to create a publication timeline, basic statistics to describe document characteristics, and qualitative content analysis to extract document themes. SETTING: Documents were retrieved from Hamilton Health Sciences, an academic hospital system with a high volume of organ donation, from database inception to October 2015. FINDINGS: We retrieved 12 active organ donation documents, including six protocols, two policies, two order sets, and two unclassified documents, a majority (75%) after the introduction of donation after circulatory death in 2006. Four major themes emerged: organ donation process, quality of care, patient and family-centred care, and the role of the institution. These themes indicate areas where documented institutional standards may be beneficial. CONCLUSION: Further research is necessary to determine the relationship of local policies, protocols, and order sets to actual organ donation practices, and to identify barriers and facilitators to improving donation rates.

Predictors of 1-year mortality in heart transplant recipients: a systematic review and meta-analysis.

OBJECTIVE: A systematic summary of the observational studies informing heart transplant guideline recommendations for selection of candidates and donors has thus far been unavailable. We performed a meta-analysis to better understand the impact of such known risk factors. METHODS: We systematically searched and meta-analysed the association between known pretransplant factor and 1-year mortality identified by multivariable regression models. Our review used the Grading of Recommendations, Assessment, Development and Evaluation for assessing the quality of assessment. We pooled risk estimates by using random effects models. RESULTS: Recipient variables including age (HR 1.16 per 10-year increase, 95% CI 1.10-1.22, high quality), congenital aetiology (HR 2.35, 95% CI 1.62 to 3.41, moderate quality), diabetes (HR 1.37, 95% CI 1.15 to 1.62, high quality), creatinine (HR 1.11 per 1 mg/dL increase, 95% CI 1.06 to 1.16, high quality), mechanical ventilation (HR 2.46, 95% CI 1.48 to 4.09, low quality) and short-term mechanical circulatory support (MCS) (HR 2.47, 95% CI 1.04 to 5.87, low quality) were significantly associated with 1-year mortality. Donor age (HR 1.20 per 10-year increase, 95% CI 1.14 to 1.26, high quality) and female donor to male recipient sex mismatch (HR 1.38, 95% CI 1.06 to 1.80, high quality) were significantly associated with 1-year mortality. None of the operative factors proved significant predictors. CONCLUSION: High-quality and moderate-quality evidence demonstrates that recipient age, congenital aetiology, creatinine, pulsatile MCS, donor age and female donor to male recipient sex mismatch are associated with 1-year mortality post heart transplant. The results of this study should inform future guideline and predictive model development.

A scoping review of intimate partner violence educational programs for health care professionals.

Multiple intimate partner violence (IPV) educational programs have been developed for health care professionals (HCPs); however, program content and effectiveness vary substantially. The purpose of this scoping review was to identify and synthesize the literature evaluating IPV education programs for HCPs to identify key areas for potential evidence-based recommendations and focus future research priorities. We conducted a systematic literature search using broad eligibility criteria to identify studies published between January 2000 and July 2015 that evaluated the effectiveness of IPV education programs in health care settings. All potentially eligible references were screened independently by two reviewers. Data extraction was completed independently by two reviewers for all eligible studies. Descriptive statistics were used to summarize all data. We identified 65 eligible studies, 55% of which reported positive program effectiveness. Effective programs often reported the use of online training components, delivery by an IPV educator/expert or physician/surgeon, the inclusion of a treatment protocol and resources for patients and HCPs, and included more than five training sessions lasting no more than one hours each. Our results demonstrate that IPV educational programs are heterogeneous and that a wide variety of methodologies have been used to evaluate their effectiveness.

Canada-DONATE study protocol: a prospective national observational study of the medical management of deceased organ donors.

INTRODUCTION: Research on the management of deceased organ donors aims to improve the number and quality of transplants and recipient outcomes. In Canada, this research is challenged by regionalisation of donation services within provinces and the geographical, clinical and administrative separation of donation from transplantation services. This study aims to build a national platform for future clinical trials in donor management. Objectives are to engage collaborators at donation hospitals and organ donation organisations (ODOs) across Canada, describe current practices, evaluate the effectiveness of donation-specific interventions and assess the feasibility of future clinical trials. METHODS AND ANALYSIS: This ongoing prospective observational study of the medical management of deceased organ donors will enrol more than 650 consented potential donors from adult intensive care units at 33 hospital sites across Canada, each participating for 12 months. ODOs ensure enrolment of consecutive eligible participants. Research staff record detailed data about participants, therapies, organ assessments, death declaration procedures and adverse clinical exposures from the time of donation consent to organ recovery. ODOs provide reasons that organs are declined, dates and places of transplantation, and recipient age and sex.Descriptive analyses will summarise current practices. Effectiveness analyses will examine donation-specific interventions with respect to the number of transplants, using multilevel regression models to account for clustering by donor, hospitals and ODOs. Feasibility analyses will focus on acceptance of the research consent model; participation of academic and community hospitals as well as ODOs; and accessibility of recipient data. ETHICS AND DISSEMINATION: This study uses a waiver of research consent. Hospitals will receive reports on local practices benchmarked to (1) national practices and (2) national donor management guidelines. We will report findings to donation and transplant collaborators (ie, clinicians, researchers, ODOs) and publish in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT03114436.

A scoping review of intimate partner violence assistance programmes within health care settings.

Background: The lifetime prevalence of intimate partner violence (IPV) for women presenting to health care settings is estimated to be 38-59%. With the goal of providing help to victims of abuse, numerous IPV assistance programmes have been developed and evaluated across multiple health care settings. Objective: Our scoping review provides an overview of this literature to identify key areas for potential evidence-based recommendations and to focus research priorities. Methods: We conducted a search of MEDLINE, Embase, Cumulative Index of Nursing and Allied Health Literature, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, and psycINFO. We used broad eligibility criteria to identify studies that evaluated the effectiveness of IPV assistance programmes delivered within health care settings. We completed all screening and data extraction independently and in duplicate. We used descriptive statistics to summarize all data. Results: Forty-three studies met all eligibility criteria and were included in our scoping review. Nine categories of assistance programmes were identified: counselling/advocacy, safety assessment/planning, referral, providing IPV resources, home visitation, case management, videos, provider cueing, and system changes. Characteristics of programmes amongst studies frequently reporting positive results included those in which one type of active assistance was used (77.8% of studies reported positive results), a counsellor, community worker, or case manager provided the intervention (83.3% of studies reported positive results), and programmes that were delivered over more than five sessions (100.0% of studies reported positive results). Conclusions: IPV assistance programmes are heterogeneous with regards to the types of assistance they include and how they are delivered and evaluated. This heterogeneity creates challenges in identifying which IPV assistance programmes, and which aspects of these programmes, are effective. However, it appears that many different types of IPV assistance programmes can have positive impacts on women.

A Scoping Review of Intimate Partner Violence Screening Programs for Health Care Professionals.

INTRODUCTION: Between 38 and 59 percent of women presenting to health care professionals have experienced intimate partner violence. Consequently, multiple intimate partner violence identification or screening programs within health care settings have been developed; however, substantial variations in program content and interpretation of program effectiveness has resulted in conflicting practice guidelines. The purpose of our scoping review is to broadly identify and synthesize the available literature evaluating intimate partner violence identification programs within health care settings to identify key areas for potential evidence-based recommendations and to focus research priorities in the field. MATERIALS AND METHODS: We conducted a search of MEDLINE, Embase, Cumulative Index of Nursing and Allied Health Literature, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, and psycINFO. We used broad eligibility criteria to identify studies that evaluated intimate partner violence identification programs in health care settings. We completed all screening and data extraction independently and in duplicate. We used descriptive statistics to summarize all data. RESULTS: We identified 59 eligible studies evaluating intimate partner violence identification programs within health care settings. The most commonly reported outcome themes were IPV disclosure (69%, n = 35), number of patients screened (39%, n = 20), HCP opinions towards screening (37%, n = 19), and patient opinions towards screening (29%, n = 15). The majority of studies (36 studies (70.6%)) reported positive program evaluation results. DISCUSSION: The majority of studies reported positive program evaluation results. This may suggest that many different intimate partner violence identification programs are beneficial for identifying victims of abuse, however, it remains unknown as to whether identification programs prevent future episodes of abuse. Additionally, the substantial heterogeneity of the intervention characteristics, study methodology, and outcome measures assessed limits the ability to make clear recommendations as to the optimal method(s) of screening.

Reporting of planned statistical methods in published surgical randomised trial protocols: a protocol for a methodological systematic review.

INTRODUCTION: Poor reporting can lead to inadequate presentation of data, confusion regarding research methodology used, selective reporting of results, and other misinformation regarding health research. One of the most recent attempts to improve quality of reporting comes from the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Group, which makes recommendations for the reporting of protocols. In this report, we present a protocol for a systematic review of published surgical randomised controlled trial (RCT) protocols, with the purpose of assessing the reporting quality and completeness of the statistical aspects. METHODS: We will include all published protocols of randomised trials that investigate surgical interventions. We will search MEDLINE, EMBASE, and CENTRAL for relevant studies. Author pairs will independently review all titles, abstracts, and full texts identified by the literature search, and extract data using a structured data extraction form. We will extract the following: year of publication, country, sample size, description of study population, description of intervention and control, primary outcome, important methodological qualities, and quality of reporting of planned statistical methods based on the SPIRIT guidelines. ETHICS AND DISSEMINATION: The results of this review will demonstrate the quality of statistical reporting of published surgical RCT protocols. This knowledge will inform recommendations to surgeons, researchers, journal editors and peer reviewers, and other knowledge users that focus on common deficiencies in reporting and how to rectify them. Ethics approval for this study is not required. We will disseminate the results of this review in peer-reviewed publications and conference presentations, and at a doctoral independent study of oral defence.

Statistical methods used in the calculation of geriatric reference intervals: a systematic review.

BACKGROUND: Geriatric reference intervals (RIs) are not commonly available and are rarely used. It is difficult to select a reference population from a cohort with a high degree of morbidity. Also important are the statistical approaches used to determine health-associated reference values. It is the aim of this study to examine the statistical methods used in the calculation of geriatric RIs. METHODS: A search was conducted on EMBASE and Medline for articles between January 1989 and January 2014. Studies were selected if they: 1) were English primary articles; 2) performed a clinical chemistry test on a blood fraction; 3) had a population sub-group consisting of individuals ≥65 years of age; and 4) calculated a RI for the subgroup ≥65 years of age. RESULTS: There were 64 articles identified, of which 78.1% described the RI calculation method used. RI calculation was performed by non-parametric (21.9%), parametric (42.2%), robust (3.1%), or other (17.2%) methods. Outlier detection (SD, Grubb's test, Tukey's fence, Dixon) was infrequently used and although most studies performed partitioning, only 57.8% tested the statistical significance of the partitions. Few studies (17.2%) reported confidence intervals for the RI estimates. Overall, only 14.1% of studies provided RI estimates which followed the CLSI guideline EP28-A3c. CONCLUSIONS: Statistical methods for RI calculation and partitioning varied considerably between studies and many failed to provide adequate descriptions of these methods. Challenges in analyses arose from insufficient sample sizes and heterogeneity in the elderly population. Geriatric RIs, although present in the literature, may not be properly calculated and should be carefully considered before applying them for clinical care.