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BACKGROUND: To reduce cesarean delivery rates in nulliparous women, guidelines for diagnosing nonprogressive labor have been developed by the National Institute of Child Health and Human Development, the American College of Obstetricians and Gynecologists, and the Society for Maternal-Fetal Medicine. These are mainly based on data from the Consortium for Safe Labor study. The guidelines have not been tested in a clinical trial, so the efficacy and safety of this new approach is uncertain. OBJECTIVE: This study aimed to assess whether adoption of new guidelines for diagnosing nonprogressing labor would reduce cesarean delivery rates. STUDY DESIGN: We conducted a cluster randomized controlled trial of a knowledge translation program of the guidelines in 26 Canadian hospitals (13 control sites and 13 intervention sites). The sites included all intrapartum care sites in Alberta that perform cesarean delivery and deliver at least 70 nulliparous women annually. The baseline period started on January 1, 2015. The intervention was initiated at the first intervention site in January 2017. The follow-up period began at the first intervention site in February 2017 and lasted till February 2020. The primary outcome was the rate of cesarean delivery in nulliparous women with vertex presentation in labor at term. The secondary outcomes included spontaneous vaginal birth and maternal and neonatal safety. The main data source for the primary and secondary outcomes was the Alberta Perinatal Health Program database. The cesarean delivery rates were assessed using repeated measures mixed effects logistic regression applied to individual births. RESULTS: The analysis was based on 45,193 deliveries at intervention sites and 43,725 deliveries at control sites. There was no evidence of a decrease in the rate of cesarean delivery in association with the intervention (baseline-adjusted odds ratio, 0.94; 95% confidence interval [0.85-1.05]; P=.259). The rate of spontaneous vaginal delivery increased slightly (baseline-adjusted odds ratio, 1.10; 95% confidence interval, [1.01-1.18]; P=.024). We did not observe any differences in adverse maternal or neonatal outcomes. CONCLUSION: Cesarean delivery rates in nulliparous women were not reduced by the application of recent guidelines for the diagnosis of nonprogressive labor. Spontaneous vaginal delivery-a secondary outcome-was increased in the intervention group. The intervention appears to be safe.
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Distocia , Trabalho de Parto , Criança , Recém-Nascido , Gravidez , Feminino , Humanos , Canadá , Cesárea , Parto Obstétrico , Distocia/epidemiologiaRESUMO
BACKGROUND: Health research partnership approaches have grown in popularity over the past decade, but the systematic evaluation of their outcomes and impacts has not kept equal pace. Identifying partnership assessment tools and key partnership characteristics is needed to advance partnerships, partnership measurement, and the assessment of their outcomes and impacts through systematic study. OBJECTIVE: To locate and identify globally available tools for assessing the outcomes and impacts of health research partnerships. METHODS: We searched four electronic databases (Ovid MEDLINE, Embase, CINAHL + , PsychINFO) with an a priori strategy from inception to June 2021, without limits. We screened studies independently and in duplicate, keeping only those involving a health research partnership and the development, use and/or assessment of tools to evaluate partnership outcomes and impacts. Reviewer disagreements were resolved by consensus. Study, tool and partnership characteristics, and emerging research questions, gaps and key recommendations were synthesized using descriptive statistics and thematic analysis. RESULTS: We screened 36 027 de-duplicated citations, reviewed 2784 papers in full text, and kept 166 studies and three companion reports. Most studies originated in North America and were published in English after 2015. Most of the 205 tools we identified were questionnaires and surveys targeting researchers, patients and public/community members. While tools were comprehensive and usable, most were designed for single use and lacked validity or reliability evidence. Challenges associated with the interchange and definition of terms (i.e., outcomes, impacts, tool type) were common and may obscure partnership measurement and comparison. Very few of the tools identified in this study overlapped with tools identified by other, similar reviews. Partnership tool development, refinement and evaluation, including tool measurement and optimization, are key areas for future tools-related research. CONCLUSION: This large scoping review identified numerous, single-use tools that require further development and testing to improve their psychometric and scientific qualities. The review also confirmed that the health partnership research domain and its measurement tools are still nascent and actively evolving. Dedicated efforts and resources are required to better understand health research partnerships, partnership optimization and partnership measurement and evaluation using valid, reliable and practical tools that meet partners' needs.
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Reprodutibilidade dos Testes , Humanos , América do NorteRESUMO
BACKGROUND: Accurate, consistent assessment of outcomes and impacts is challenging in the health research partnerships domain. Increased focus on tool quality, including conceptual, psychometric and pragmatic characteristics, could improve the quantification, measurement and reporting partnership outcomes and impacts. This cascading review was undertaken as part of a coordinated, multicentre effort to identify, synthesize and assess a vast body of health research partnership literature. OBJECTIVE: To systematically assess the outcomes and impacts of health research partnerships, relevant terminology and the type/use of theories, models and frameworks (TMF) arising from studies using partnership assessment tools with known conceptual, psychometric and pragmatic characteristics. METHODS: Four electronic databases were searched (MEDLINE, Embase, CINAHL Plus and PsycINFO) from inception to 2 June 2021. We retained studies containing partnership evaluation tools with (1) conceptual foundations (reference to TMF), (2) empirical, quantitative psychometric evidence (evidence of validity and reliability, at minimum) and (3) one or more pragmatic characteristics. Outcomes, impacts, terminology, definitions and TMF type/use were abstracted verbatim from eligible studies using a hybrid (independent abstraction-validation) approach and synthesized using summary statistics (quantitative), inductive thematic analysis and deductive categories (qualitative). Methodological quality was assessed using the Quality Assessment Tool for Studies with Diverse Designs (QATSDD). RESULTS: Application of inclusion criteria yielded 37 eligible studies. Study quality scores were high (mean 80%, standard deviation 0.11%) but revealed needed improvements (i.e. methodological, reporting, user involvement in research design). Only 14 (38%) studies reported 48 partnership outcomes and 55 impacts; most were positive effects (43, 90% and 47, 89%, respectively). Most outcomes were positive personal, functional, structural and contextual effects; most impacts were personal, functional and contextual in nature. Most terms described outcomes (39, 89%), and 30 of 44 outcomes/impacts terms were unique, but few were explicitly defined (9, 20%). Terms were complex and mixed on one or more dimensions (e.g. type, temporality, stage, perspective). Most studies made explicit use of study-related TMF (34, 92%). There were 138 unique TMF sources, and these informed tool construct type/choice and hypothesis testing in almost all cases (36, 97%). CONCLUSION: This study synthesized partnership outcomes and impacts, deconstructed term complexities and evolved our understanding of TMF use in tool development, testing and refinement studies. Renewed attention to basic concepts is necessary to advance partnership measurement and research innovation in the field. Systematic review protocol registration: PROSPERO protocol registration: CRD42021137932 https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=137932 .
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Reprodutibilidade dos Testes , Humanos , PsicometriaRESUMO
BACKGROUND AND PURPOSE: Improving door-to-needle times (DNTs) for thrombolysis of acute ischemic stroke patients improves outcomes, but participation in DNT improvement initiatives has been mostly limited to larger, academic medical centers with an existing interest in stroke quality improvement. It is not known whether quality improvement initiatives can improve DNT at a population level, including smaller community hospitals. This study aims to determine the effect of a provincial improvement collaborative intervention on improvement of DNT and patient outcomes. METHODS: A pre post cohort study was conducted over 10 years in the Canadian province of Alberta with 17 designated stroke centers. All ischemic stroke patients who received thrombolysis in the Canadian province of Alberta were included in the study. The quality improvement intervention was an improvement collaborative that involved creation of interdisciplinary teams from each stroke center, participation in 3 workshops and closing celebration, site visits, webinars, and data audit and feedback. RESULTS: Two thousand four hundred eighty-eight ischemic stroke patients received thrombolysis in the pre- and postintervention periods (630 in the post period). The mean age was 71 years (SD, 14.6 years), and 46% were women. DNTs were reduced from a median of 70.0 minutes (interquartile range, 51-93) to 39.0 minutes (interquartile range, 27-58) for patients treated per guideline (P<0.0001). The percentage of patients discharged home from acute care increased from 45.6% to 59.5% (P<0.0001); the median 90-day home time increased from 43.3 days (interquartile range, 27.3-55.8) to 53.6 days (interquartile range, 36.8-64.6) (P=0.0015); and the in-hospital mortality decreased from 14.5% to 10.5% (P=0.0990). CONCLUSIONS: The improvement collaborative was likely the key contributing factor in reducing DNTs and improving outcomes for ischemic stroke patients across Alberta.
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Isquemia Encefálica/tratamento farmacológico , Medidas de Resultados Relatados pelo Paciente , Vigilância da População , Acidente Vascular Cerebral/tratamento farmacológico , Tempo para o Tratamento/normas , Ativador de Plasminogênio Tecidual/administração & dosagem , Idoso , Idoso de 80 Anos ou mais , Alberta/epidemiologia , Isquemia Encefálica/epidemiologia , Estudos de Coortes , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Vigilância da População/métodos , Acidente Vascular Cerebral/epidemiologia , Terapia Trombolítica/normas , Terapia Trombolítica/tendências , Tempo para o Tratamento/tendênciasRESUMO
BACKGROUND: Parents of infants in neonatal intensive care units (NICUs) are often unintentionally marginalized in pursuit of optimal clinical care. Family Integrated Care (FICare) was developed to support families as part of their infants' care team in level III NICUs. We adapted the model for level II NICUs in Alberta, Canada, and evaluated whether the new Alberta FICare™ model decreased hospital length of stay (LOS) in preterm infants without concomitant increases in readmissions and emergency department visits. METHODS: In this pragmatic cluster randomized controlled trial conducted between December 15, 2015 and July 28, 2018, 10 level II NICUs were randomized to provide Alberta FICare™ (n = 5) or standard care (n = 5). Alberta FICare™ is a psychoeducational intervention with 3 components: Relational Communication, Parent Education, and Parent Support. We enrolled mothers and their singleton or twin infants born between 32 0/7 and 34 6/7 weeks gestation. The primary outcome was infant hospital LOS. We used a linear regression model to conduct weighted site-level analysis comparing adjusted mean LOS between groups, accounting for site geographic area (urban/regional) and infant risk factors. Secondary outcomes included proportions of infants with readmissions and emergency department visits to 2 months corrected age, type of feeding at discharge, and maternal psychosocial distress and parenting self-efficacy at discharge. RESULTS: We enrolled 654 mothers and 765 infants (543 singletons/111 twin cases). Intention to treat analysis included 353 infants/308 mothers in the Alberta FICare™ group and 365 infants/306 mothers in the standard care group. The unadjusted difference between groups in infant hospital LOS (1.96 days) was not statistically significant. Accounting for site geographic area and infant risk factors, infant hospital LOS was 2.55 days shorter (95% CI, - 4.44 to - 0.66) in the Alberta FICare™ group than standard care group, P = .02. Secondary outcomes were not significantly different between groups. CONCLUSIONS: Alberta FICare™ is effective in reducing preterm infant LOS in level II NICUs, without concomitant increases in readmissions or emergency department visits. A small number of sites in a single jurisdiction and select group infants limit generalizability of findings. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT02879799 , retrospectively registered August 26, 2016.
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Prestação Integrada de Cuidados de Saúde , Unidades de Terapia Intensiva Neonatal , Adulto , Alberta , Feminino , Humanos , Lactente , Recém-Nascido , Recém-Nascido Prematuro , Tempo de InternaçãoRESUMO
BACKGROUND: Research funders in Canada and abroad have made substantial investments in supporting collaborative research approaches to generating and translating knowledge as it is believed to increase knowledge use. Canadian health research funders have advocated for the use of integrated knowledge translation (IKT) in health research, however, there is limited research around how IKT compares to other collaborative research approaches. Our objective was to better understand how IKT compares with engaged scholarship, Mode 2 research, co-production and participatory research by identifying the differences and similarities among them in order to provide conceptual clarity and reduce researcher and knowledge user confusion about these common approaches. METHODS: We employed a qualitative descriptive method using interview data to better understand experts' perspectives and experiences on collaborative research approaches. Participants' responses were analysed through thematic analysis to elicit core themes. The analysis was centred around the concept of IKT, as it is the most recent approach; IKT was then compared and contrasted with engaged scholarship, Mode 2 research, co-production and participatory research. As this was an iterative process, data triangulation and member-checking were conducted with participants to ensure accuracy of the emergent themes and analysis process. RESULTS: Differences were noted in the orientation (i.e. original purpose), historical roots (i.e. disciplinary origin) and partnership/engagement (i.e. role of partners etc.). Similarities among the approaches included (1) true partnerships rather than simple engagement, (2) focus on essential components and processes rather than labels, (3) collaborative research orientations rather than research methods, (4) core values and principles, and (5) extensive time and financial investment. Core values and principles among the approaches included co-creation, reciprocity, trust, fostering relationships, respect, co-learning, active participation, and shared decision-making in the generation and application of knowledge. All approaches require extensive time and financial investment to develop and maintain true partnerships. CONCLUSIONS: This qualitative study is the first to systematically synthesise experts' perspectives and experiences in a comparison of collaborative research approaches. This work contributes to developing a shared understanding of collaborative research approaches to facilitate conceptual clarity in use, reporting, indexing and communication among researchers, trainees, knowledge users and stakeholders to advance IKT and implementation science.
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Atenção à Saúde/métodos , Pessoal de Saúde/psicologia , Disseminação de Informação/métodos , Cooperação Internacional , Pesquisadores/psicologia , Pesquisa Translacional Biomédica/métodos , Adulto , Austrália , Canadá , Feminino , Humanos , Irlanda , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Estados UnidosRESUMO
BACKGROUND: As it may be argued that many surgical interventions provide obvious patient benefits, formal, staged assessment of the efficacy and safety of surgical procedures has historically been and remains uncommon. The majority of innovative surgical procedures have therefore often been developed based on anatomical and pathophysiological principles in an attempt to better manage clinical problems. MAIN BODY: In this manuscript, we sought to review and contrast the models for pharmaceutical and surgical innovation in North America, including their stages of development and methods of evaluation, monitoring, and regulation. We also aimed to review the present structure of academic surgery, the role of methodological experts and funding in conducting surgical research, and the current system of regulation of innovative surgical procedures. Finally, we highlight the influence that evidence and surgical history, education, training, and culture have on elective and emergency surgical decision-making. The above discussion is used to support the argument that the model used for assessment of innovative pharmaceuticals cannot be applied to that for evaluating surgical innovations. It is also used to support our position that although the evaluation and monitoring of innovative surgical procedures requires a rigorous, fit-for-purpose, and formal system of assessment to protect patient safety and prevent unexpected adverse health outcomes, it will only succeed if it is supported and championed by surgical practice leaders and respects surgical history, education, training, and culture. CONCLUSION: We conclude the above debate by providing a recommended approach to the evaluation, monitoring, and regulation of surgical innovations, which we hope may be used as a guide for all stakeholders involved in interpreting and/or conducting future surgical research.
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Tomada de Decisões , Segurança do Paciente , Procedimentos Cirúrgicos Operatórios/métodos , HumanosRESUMO
BACKGROUND: Body temperature is commonly used to screen patients for infectious diseases, establish diagnoses, monitor therapy, and guide management decisions. PURPOSE: To determine the accuracy of peripheral thermometers for estimating core body temperature in adults and children. DATA SOURCES: MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, and CINAHL Plus from inception to July 2015. STUDY SELECTION: Prospective studies comparing the accuracy of peripheral (tympanic membrane, temporal artery, axillary, or oral) thermometers with central (pulmonary artery catheter, urinary bladder, esophageal, or rectal) thermometers. DATA EXTRACTION: 2 reviewers extracted data on study characteristics, methods, and outcomes and assessed the quality of individual studies. DATA SYNTHESIS: 75 studies (8682 patients) were included. Most studies were at high or unclear risk of patient selection bias (74%) or index test bias (67%). Compared with central thermometers, peripheral thermometers had pooled 95% limits of agreement (random-effects meta-analysis) outside the predefined clinically acceptable range (± 0.5 °C), especially among patients with fever (-1.44 °C to 1.46 °C for adults; -1.49 °C to 0.43 °C for children) and hypothermia (-2.07 °C to 1.90 °C for adults; no data for children). For detection of fever (bivariate random-effects meta-analysis), sensitivity was low (64% [95% CI, 55% to 72%]; I2 = 95.7%; P < 0.001) but specificity was high (96% [CI, 93% to 97%]; I2 = 96.3%; P < 0.001). Only 1 study reported sensitivity and specificity for the detection of hypothermia. LIMITATIONS: High-quality data for some temperature measurement techniques are limited. Pooled data are associated with interstudy heterogeneity that is not fully explained by stratified and metaregression analyses. CONCLUSION: Peripheral thermometers do not have clinically acceptable accuracy and should not be used when accurate measurement of body temperature will influence clinical decisions. PRIMARY FUNDING SOURCE: None.
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Termômetros/normas , Adulto , Axila , Criança , Febre/diagnóstico , Humanos , Hipotermia/diagnóstico , Boca , Artérias Temporais , Membrana TimpânicaRESUMO
BACKGROUND: Low-value clinical practices are common in healthcare, yet the optimal approach to de-adopting these practices is unknown. The objective of this study was to systematically review the literature on de-adoption, document current terminology and frameworks, map the literature to a proposed framework, identify gaps in our understanding of de-adoption, and identify opportunities for additional research. METHODS: MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, the Cochrane Database of Systematic Reviews, the Cochrane Database of Abstracts and Reviews of Effects, and CINAHL Plus were searched from 1 January 1990 to 5 March 2014. Additional citations were identified from bibliographies of included citations, relevant websites, the PubMed 'related articles' function, and contacting experts in implementation science. English-language citations that referred to de-adoption of clinical practices in adults with medical, surgical, or psychiatric illnesses were included. Citation selection and data extraction were performed independently and in duplicate. RESULTS: From 26,608 citations, 109 were included in the final review. Most citations (65%) were original research with the majority (59%) published since 2010. There were 43 unique terms referring to the process of de-adoption-the most frequently cited was "disinvest" (39% of citations). The focus of most citations was evaluating the outcomes of de-adoption (50%), followed by identifying low-value practices (47%), and/or facilitating de-adoption (40%). The prevalence of low-value practices ranged from 16% to 46%, with two studies each identifying more than 100 low-value practices. Most articles cited randomized clinical trials (41%) that demonstrate harm (73%) and/or lack of efficacy (63%) as the reason to de-adopt an existing clinical practice. Eleven citations described 13 frameworks to guide the de-adoption process, from which we developed a model for facilitating de-adoption. Active change interventions were associated with the greatest likelihood of de-adoption. CONCLUSIONS: This review identified a large body of literature that describes current approaches and challenges to de-adoption of low-value clinical practices. Additional research is needed to determine an ideal strategy for identifying low-value practices, and facilitating and sustaining de-adoption. In the meantime, this study proposes a model that providers and decision-makers can use to guide efforts to de-adopt ineffective and harmful practices.
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Padrões de Prática Médica/normas , Melhoria de Qualidade , Tomada de Decisões , Humanos , Segurança do Paciente , Revisão dos Cuidados de Saúde por Pares , Revisão da Utilização de Recursos de SaúdeRESUMO
STUDY DESIGN: Scoping review. OBJECTIVE: To identify and provide systematic overviews of partnership principles and strategies identified from health research about spinal cord injury (SCI) and related health conditions. METHODS: Four health electronic databases (Medline, Embase, CINAHL, PsycINFO) were searched from inception to March 2019. We included articles that described, reflected, and/or evaluated one or more collaborative research activities in health research about SCI, stroke, multiple sclerosis, Parkinson's disease, amputation, cerebral palsy, spina bifida, amyotrophic lateral sclerosis, acquired brain injury, or wheelchair-users. Partnership principles (i.e. norms or values) and strategies (i.e. observable actions) were extracted and analyzed using directed qualitative content analysis. RESULTS: We included 39 articles about SCI (n = 13), stroke (n = 15), multiple sclerosis (n = 5), amputation (n = 2), cerebral palsy (n = 2), Parkinson's disease (n = 1), and wheelchair users (n = 1). We extracted 110 principles and synthesized them into 13 overarching principles. Principles related to building and maintaining relationships between researchers and research users were most frequently reported. We identified 32 strategies that could be applied at various phases of the research process and 26 strategies that were specific to a research phase (planning, conduct, or dissemination). CONCLUSION: We provided systematic overviews of principles and strategies for research partnerships. These could be used by researchers and research users who want to work in partnership to plan, conduct and/or disseminate their SCI research. The findings informed the development of the new SCI Integrated Knowledge Translation Guiding Principles (www.iktprinciples.com) and will support the implementation of these Principles within the SCI research system.
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Paralisia Cerebral , Esclerose Múltipla , Doença de Parkinson , Traumatismos da Medula Espinal , HumanosRESUMO
BACKGROUND: Choosing Wisely Canada and most major anesthesia and preoperative guidelines recommend against obtaining preoperative tests before low-risk procedures. However, these recommendations alone have not reduced low-value test ordering. In this study, the theoretical domains framework (TDF) was used to understand the drivers of preoperative electrocardiogram (ECG) and chest X-ray (CXR) ordering for patients undergoing low-risk surgery ('low-value preoperative testing') among anesthesiologists, internal medicine specialists, nurses, and surgeons. METHODS: Using snowball sampling, preoperative clinicians working in a single health system in Canada were recruited for semi-structured interviews about low-value preoperative testing. The interview guide was developed using the TDF to identify the factors that influence preoperative ECG and CXR ordering. Interview content was deductively coded using TDF domains and specific beliefs were identified by grouping similar utterances. Domain relevance was established based on belief statement frequency, presence of conflicting beliefs, and perceived influence over preoperative test ordering practices. RESULTS: Sixteen clinicians (7 anesthesiologists, 4 internists, 1 nurse, and 4 surgeons) participated. Eight of the 12 TDF domains were identified as the drivers of preoperative test ordering. While most participants agreed that the guidelines were helpful, they also expressed distrust in the evidence behind them (knowledge). Both a lack of clarity about the responsibilities of the specialties involved in the preoperative process and the ease by which any clinician could order, but not cancel tests, were drivers of low-value preoperative test ordering (social/professional role and identity, social influences, belief about capabilities). Additionally, low-value tests could also be ordered by nurses or the surgeon and may be completed before the anesthesia or internal medicine preoperative assessment appointment (environmental context and resources, beliefs about capabilities). Finally, while participants agreed that they did not intend to routinely order low-value tests and understood that these would not benefit patient outcomes, they also reported ordering tests to prevent surgery cancellations and problems during surgery (motivation and goals, beliefs about consequences, social influences). CONCLUSIONS: We identified key factors that anesthesiologists, internists, nurses, and surgeons believe influence preoperative test ordering for patients undergoing low-risk surgeries. These beliefs highlight the need to shift away from knowledge-based interventions and focus instead on understanding local drivers of behaviour and target change at the individual, team, and institutional levels.
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BACKGROUND: Acute exacerbations of COPD (AECOPD) are associated with high morbidity and mortality and frequent readmissions. RESEARCH QUESTION: What is the effectiveness of a COPD transition bundle, with and without a care coordinator, on rehospitalizations and ED revisits? STUDY DESIGN AND METHODS: Two patient cohorts were selected: (1) the group exposed to the transition bundle and (2) the group not exposed to the transition bundle (usual care group). Patients exposed subsequently were randomized to a care coordinator. An AECOPD transition bundle was implemented in the hospital; patients randomized to the care coordinator were contacted ≤ 72 h after discharge. Six hundred four patients (320 to the care coordinator and 284 to routine care) who met eligibility criteria from five hospitals across three cities in Alberta, Canada, were exposed to the transition bundle, whereas 3,106 patients discharged from the same hospitals received the usual care. Primary outcomes were 7-day, 30-day, and 90-day readmissions, median length of stay (LOS), and 30-day ED revisits. RESULTS: The transition bundle cohort were 83% (relative risk [RR], 0.17; 95% CI, 0.07-0.35) less likely to be readmitted within 7 days and 26% (RR, 0.74; 95% CI, 0.60-0.91) less likely to be readmitted within 30 days of discharge. Ninety-day readmissions were unchanged (RR, 1.05; 95% CI, 0.93-1.18). The transition bundle was associated with a 7.3% (RR, 1.07; 95% CI, 1.0-1.15) relative increase in LOS and a 76% (RR, 1.76; 95% CI, 1.53-2.02) greater risk of a 30-day ED revisit. The care coordinator did not influence readmission or ED revisits. INTERPRETATION: The COPD transition bundle reduced 7- and 30-day hospital readmissions while increasing LOS and ED revisits. The care coordinator did not improve outcomes. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT03358771; URL: www. CLINICALTRIALS: gov.
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Readmissão do Paciente , Doença Pulmonar Obstrutiva Crônica , Alberta , Serviço Hospitalar de Emergência , Humanos , Tempo de Internação , Alta do Paciente , Doença Pulmonar Obstrutiva Crônica/terapiaRESUMO
BACKGROUND: Insomnia and sleep disturbances are common in pregnancy and have potentially significant consequences for both maternal and infant health. There is limited research examining the effectiveness of cognitive behavioral therapy for insomnia (CBT-I) during pregnancy. With increased distress and limited access to services during the COVID-19 pandemic, there is also an unprecedented need for telehealth delivery of treatment programs for pregnant women. The aims of this trial are to evaluate the impact of the Sleeping for Two adaptation of CBT-I in pregnancy (in-person or telehealth) versus treatment as usual (TAU) in reducing symptoms of insomnia (primary outcome), as well as increasing gestational length and reducing symptoms of depression (secondary outcomes). METHODS: A two-arm, single-blinded, parallel group randomized controlled trial (RCT) design with repeated measures will be used to evaluate the impact of CBT-I compared to TAU among a sample of 62 pregnant women, enrolled between 12 and 28 weeks of gestation, who self-identify as experiencing insomnia. Five weekly individual sessions of CBT-I will be delivered in person or via telehealth depending on physical distancing guidelines. Assessment of insomnia diagnosis by structured interview, self-reported insomnia symptom severity and sleep problems, and sleep quantity and quality as measured by a daily diary and actigraphy will occur at 12-28 weeks of pregnancy (T1), 1 week post-treatment (T2), and 6 months postpartum (T3). DISCUSSION: CBT-I delivered in pregnancy has the potential to reduce symptoms of insomnia and depression and could lead to reduced risk of preterm birth, all of which can minimize risk of negative maternal and child health and developmental consequences in the short (e.g., infant death) and long terms (e.g., developmental delays). This RCT builds on a successful open pilot trial conducted by our team and will provide further evaluation of a novel evidence-based treatment for pregnancy-related insomnia, which can be widely disseminated and used to treat individuals that are most in need of intervention. Findings will enhance understanding of pregnancy-related sleep problems, as well as means by which to improve the health and sleep of mothers and their children. TRIAL REGISTRATION: ClinicalTrials.gov NCT03918057. Registered on 17 April 2019.
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COVID-19 , Terapia Cognitivo-Comportamental , Distúrbios do Início e da Manutenção do Sono , Criança , Feminino , Humanos , Recém-Nascido , Gravidez , Gestantes , Ensaios Clínicos Controlados Aleatórios como Assunto , SARS-CoV-2 , Sono , Distúrbios do Início e da Manutenção do Sono/diagnóstico , Distúrbios do Início e da Manutenção do Sono/terapia , Resultado do TratamentoRESUMO
BACKGROUND: In a previous study, a prototype mobile health (mHealth) app was co-designed with patients, family physicians, and researchers to enhance self-management and optimize conservative management for patients with mild to moderate knee osteoarthritis (OA). OBJECTIVE: This study aims to evaluate the overall usability, quality, and effectiveness of the mHealth app prototype for aiding knee OA self-management from the perspectives of patients with OA and health care providers (HCPs). METHODS: Using methods triangulation of qualitative and quantitative data, we conducted a pilot evaluation of an mHealth app prototype that was codeveloped with patients and HCPs. We recruited adult patients aged ≥20 years with early knee OA (n=18) who experienced knee pain on most days of the month at any time in the past and HCPs (n=7) to participate. In the qualitative assessment, patient and HCP perspectives were elicited on the likeability and usefulness of app features and functionalities and the perceived impact of the app on patient-HCP communication. The quantitative assessment involved evaluating the app using usability, quality, and effectiveness metrics. Patient baseline assessments included a semistructured interview and survey to gather demographics and assess the quality of life (European Quality-of-Life 5-Dimension 5-Level Questionnaire [EQ-5D-5L]) and patient activation (patient activation measure [PAM]). Following the 6-week usability trial period, a follow-up survey assessed patients' perceptions of app usability and quality and longitudinal changes in quality of life and patient activation. Semistructured interviews and surveys were also conducted with HCPs (n=7) at baseline to evaluate the usability and quality of the app prototype. RESULTS: Interviews with patients and HCPs revealed overall positive impressions of the app prototype features and functionalities related to likeability and usefulness. Between the baseline and follow-up patient assessments, the mean EQ-5D-5L scores improved from 0.77 to 0.67 (P=.04), and PAM scores increased from 80.4 to 87.9 (P=.01). Following the 6-week evaluation, patients reported a mean System Usability Scale (SUS) score of 57.8, indicating marginal acceptability according to SUS cutoffs. The mean number of goals set during the usability period was 2.47 (SD 3.08), and the mean number of activities completed for knee OA self-management during the study period was 22.2 (SD 17.8). Spearman rank correlation (rs) calculations revealed that the follow-up PAM scores were weakly correlated (rs=-0.32) with the number of goals achieved and the number (rs=0.19) of activities performed during the 6-week usability period. HCPs reported a mean SUS score of 39.1, indicating unacceptable usability. CONCLUSIONS: This evidence-based and patient-centered app prototype represents a potential use of mHealth for improving outcomes and enhancing conservative care by promoting patient activation and patient-HCP communication regarding OA management. However, future iterations of the app prototype are required to address the limitations related to usability and quality.
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BACKGROUND: Despite a doubling of osteoarthritis-targeted mobile health (mHealth) apps and high user interest and demand for health apps, their impact on patients, patient outcomes, and providers has not met expectations. Most health and medical apps fail to retain users longer than 90 days, and their potential for facilitating disease management, data sharing, and patient-provider communication is untapped. An important, recurrent criticism of app technology development is low user integration design. User integration ensures user needs, desires, functional requirements, and app aesthetics are responsive and reflect target user preferences. OBJECTIVE: This study aims to describe the co-design process for developing a knee osteoarthritis minimum viable product (MVP) mHealth app with patients, family physicians, and researchers that facilitates guided, evidence-based self-management and patient-physician communication. METHODS: Our qualitative co-design approach involved focus groups, prioritization activities, and a pre-post quality and satisfaction Kano survey. Study participants included family physicians, patient researchers and patients with knee osteoarthritis (including previous participants of related collaborative research), researchers, key stakeholders, and industry partners. The study setting was an academic health center in Southern Alberta. RESULTS: Distinct differences exist between what patients, physicians, and researchers perceive are the most important, convenient, desirable, and actionable app functional requirements. Despite differences, study participants agreed that the MVP should be electronic, should track patient symptoms and activities, and include features customized for patient- and physician-identified factors and international guideline-based self-management strategies. Through the research process, participants negotiated consensus on their respective priority functional requirements. The highest priorities were a visual symptom graph, setting goals, exercise planning and daily tracking, and self-management strategies. The structured co-design with patients, physicians, and researchers established multiple collaborative processes, grounded in shared concepts, language, power, rationale, mutual learning, and respect for diversity and differing opinions. These shared team principles fostered an open and inclusive environment that allowed for effective conceptualization, negotiation, and group reflection, aided by the provision of tangible and ongoing support throughout the research process, which encouraged team members to question conventional thinking. Group-, subgroup-, and individual-level data helped the team reveal how and for whom perspectives about individual functional requirements changed or remained stable over the course of the study. This provided valuable insight into how and why consensus emerged, despite the presence of multiple and differing underlying rationales for functional requirement prioritization. CONCLUSIONS: It is feasible to preserve the diversity of perspectives while negotiating a consensus on the core functional requirements of an mHealth prototype app for knee osteoarthritis management. Our study sample was purposely constructed to facilitate high co-design interactivity. This study revealed important differences between the patient, physician, and researcher preferences for functional requirements of an mHealth app that did not preclude the development of consensus.
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Aplicativos Móveis , Osteoartrite do Joelho , Telemedicina , Alberta , Feminino , Humanos , Masculino , Osteoartrite do Joelho/terapia , Participação do Paciente , MédicosRESUMO
BACKGROUND: In addition to the obvious physical medical impact of COVID-19, the disease poses evident threats to people's mental health, psychological safety, and well-being. Provision of support for these challenges is complicated by the high number of people requiring support and the need to maintain physical distancing. Text4Hope, a daily supportive SMS text messaging program, was launched in Canada to mitigate the negative mental health impacts of the pandemic among Canadians. OBJECTIVE: This paper describes the changes in the stress, anxiety, and depression levels of subscribers to the Text4Hope program after 6 weeks of exposure to daily supportive SMS text messages. METHODS: We used self-administered, empirically supported web-based questionnaires to assess the demographic and clinical characteristics of Text4Hope subscribers. Perceived stress, anxiety, and depression were measured with the 10-Item Perceived Stress Scale (PSS-10), the Generalized Anxiety Disorder-7 (GAD-7) scale, and the Patient Health Questionnaire-9 (PHQ-9) scale at baseline and sixth week time points. Moderate or high perceived stress, likely generalized anxiety disorder, and likely major depressive disorder were assessed using cutoff scores of ≥14 for the PSS-10, ≥10 for the GAD-7, and ≥10 for the PHQ-9, respectively. At 6 weeks into the program, 766 participants had completed the questionnaires at both time points. RESULTS: At the 6-week time point, there were statistically significant reductions in mean scores on the PSS-10 and GAD-7 scales but not on the PHQ-9 scale. Effect sizes were small overall. There were statistically significant reductions in the prevalence rates of moderate or high stress and likely generalized anxiety disorder but not likely major depressive disorder for the group that completed both the baseline and 6-week assessments. The largest reductions in mean scores and prevalence rates were for anxiety (18.7% and 13.5%, respectively). CONCLUSIONS: Text4Hope is a convenient, cost-effective, and accessible means of implementing a population-level psychological intervention. This service demonstrated significant reductions in anxiety and stress levels during the COVID-19 pandemic and could be used as a population-level mental health intervention during natural disasters and other emergencies. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/19292.
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BACKGROUND: Opiate agonist therapy (OAT) prescribing rates by family physicians are low in the context of community-based, comprehensive primary care. Understanding the factors that support and/or inhibit OAT prescribing within primary care is needed. Our study objectives are to identify and synthesize documented barriers to, and facilitators of, primary care opioid agonist prescribing, and effective strategies to inform intervention planning and support increased primary care OAT prescribing. METHODS/DESIGN: We will systematically search EMBASE, CINAHL, PsycINFO, Cochrane Central Register of Controlled Trials, MEDLINE, and gray literature in three domains: primary care providers, opioid agonist therapy, and opioid abuse. We will retain and assess primary studies reporting documented participation, or self-reported willingness to participate, in OAT prescribing; and/or at least one determinant of OAT prescribing; and/or strategies to address determinants of OAT prescribing from the perspective of primary care providers in comprehensive, community-based practice settings. There will be no restrictions on study design or publication date. Studies limited to specialty clinics with specialist prescribers, lacking extractable data, or in languages other than English or French will be excluded. Two reviewers will perform abstract review and data extraction independently. We will assess the quality of included studies using the Joanna Briggs Institute Critical Appraisal Tool. We will use a framework method of analysis to deductively code barriers and facilitators and to characterize effective strategies to support prescribing using a combined, modified a priori framework comprising the Theoretical Domains Framework and the Consolidated Framework for Implementation Research. DISCUSSION: To date, no synthesis has been undertaken of the barriers and facilitators or effective interventions promoting OAT prescribing by primary care clinicians in community-based comprehensive care settings. Enacting change in physician behaviors, community-based programming, and health services is complex and best informed by using theoretical frameworks that allow the analysis of the available data to assist in designing and implementing interventions. In light of the current opioid crisis, increasing the capacity of primary care clinicians to provide OAT is an important strategy to curb morbidity and mortality from opioid use disorder. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD86835.
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Analgésicos Opioides/efeitos adversos , Transtornos Relacionados ao Uso de Opioides/tratamento farmacológico , Médicos de Família , Padrões de Prática Médica/estatística & dados numéricos , Atenção Primária à Saúde/estatística & dados numéricos , Combinação Buprenorfina e Naloxona/administração & dosagem , Humanos , Metadona/administração & dosagem , Tratamento de Substituição de Opiáceos , Revisões Sistemáticas como AssuntoRESUMO
BACKGROUND: Research partnership approaches, in which researchers and stakeholders work together collaboratively on a research project, are an important component of research, knowledge translation, and implementation. Despite their growing use, a comprehensive understanding of the principles, strategies, outcomes, and impacts of different types of research partnerships is lacking. Generating high-quality evidence in this area is challenging due to the breadth and diversity of relevant literature. We established a Coordinated Multicenter Team approach to identify and synthesize the partnership literature and better understand the evidence base. This review protocol outlines an innovative approach to locating, reviewing, and synthesizing the literature on research partnerships. METHODS: Five reviews pertaining to research partnerships are proposed. The Coordinated Multicenter Team developed a consensus-driven conceptual framework to guide the reviews. First, a review of reviews will comparatively describe and synthesize key domains (principles, strategies, outcomes, and impacts) for different research partnership approaches, within and beyond health (e.g., integrated knowledge translation, participatory action research). After identifying commonly used search terminology, three complementary scoping reviews will describe and synthesize these domains in the health research partnership literature. Finally, an umbrella review will amalgamate and reflect on the collective findings and identify research gaps and future directions. We will develop a collaborative review methodology, comprising search strategy efficiencies, terminology standardization, and the division of screening, extraction, and synthesis to optimize feasibility and literature capture. A series of synthesis and scoping manuscripts will emerge from this Coordinated Multicenter Team approach. DISCUSSION: Comprehensively describing and differentiating research partnership terminology and its domains will address well-documented gaps in the literature. These efforts will contribute to and improve the quality, conduct, and reporting of research partnership literature. The collaborative review methodology will help identify and establish common terms, leverage efficiencies (e.g., expertise, experience, search and protocol design, resources) and optimize research feasibility and quality. Our approach allows for enhanced scope and inclusivity of all research user groups and domains, thereby contributing uniquely to the literature. This multicenter, efficiency and quality-focused approach may serve to inspire researchers across the globe in addressing similar domain challenges, as exist in this rapidly expanding field.
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Pesquisa Participativa Baseada na Comunidade , Comportamento Cooperativo , Pesquisa sobre Serviços de Saúde/métodos , Projetos de Pesquisa , Humanos , Participação dos Interessados , Revisões Sistemáticas como AssuntoRESUMO
BACKGROUND: Despite the existence of human papilloma virus (HPV) vaccines with demonstrated safety and effectiveness and funded HPV vaccination programs, coverage rates are persistently lower and cervical cancer burden higher among Canadian Indigenous peoples. Barriers and supports to HPV vaccination in Indigenous peoples have not been systematically documented, nor have interventions to increase uptake in this population. This protocol aims to appraise the literature in Canadian and global Indigenous peoples, relating to documented barriers and supports to vaccination and interventions to increase acceptability/uptake or reduce hesitancy of vaccination. Although HPV vaccination is the primary focus, we anticipate only a small number of relevant studies to emerge from the search and will, therefore, employ a broad search strategy to capture literature related to both HPV vaccination and vaccination in general in global Indigenous peoples. METHODS: Eligible studies will include global Indigenous peoples and discuss barriers or supports and/or interventions to improve uptake or to reduce hesitancy, for the HPV vaccine and/or other vaccines. Primary outcomes are documented barriers or supports or interventions. All study designs meeting inclusion criteria will be considered, without restricting by language, location, or data type. We will use an a priori search strategy, comprised of key words and controlled vocabulary terms, developed in consultation with an academic librarian, and reviewed by a second academic librarian using the PRESS checklist. We will search several electronic databases from date of inception, without restrictions. A pre-defined group of global Indigenous websites will be reviewed for relevant gray literature. Bibliographic searches will be conducted for all included studies to identify relevant reviews. Data analysis will include an inductive, qualitative, thematic synthesis and a quantitative analysis of measured barriers and supports, as well as a descriptive synthesis and quantitative summary of measures for interventions. DISCUSSION: To our knowledge, this study will contribute the first systematic review of documented barriers, supports, and interventions for vaccination in general and for HPV vaccination. The results of this study are expected to inform future research, policies, programs, and community-driven initiatives to enhance acceptability and uptake of HPV vaccination among Indigenous peoples. SYSTEMATIC REVIEW REGISTRATION: PROSPERO Registration Number: CRD42017048844.
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Infecções por Papillomavirus/prevenção & controle , Vacinas contra Papillomavirus/administração & dosagem , Aceitação pelo Paciente de Cuidados de Saúde/etnologia , Grupos Populacionais/etnologia , Vacinação , Canadá , Feminino , Serviços de Saúde do Indígena , Humanos , Neoplasias do Colo do Útero/prevenção & controleRESUMO
BACKGROUND: Failure to detect depression in patients with Parkinson disease (PD) can lead to worsened outcomes for patients and caregivers. Accurate identification of depression would enable practitioners to provide comprehensive care for their patients with PD. METHODS: Our objective was to examine the diagnostic accuracy of tools for detecting depression in adult outpatients with PD. We searched MEDLINE, PsycINFO, and EMBASE (inception to December 1, 2015), gray literature, and bibliographies of included studies. The pooled prevalence of depression across studies and diagnostic accuracy estimates were calculated using random-effects models. Diagnostic accuracy estimates were calculated across the best-reported cutoffs from each study and across specific cutoffs, when feasible. RESULTS: Out of 8,184 citations, 21 studies were included, evaluating 24 tools, with 4 amenable to meta-analysis. The pooled prevalence of major depression was 22.9% (95% confidence interval [CI] 18.1-27.7). The 15-item Geriatric Depression Scale (GDS-15) had a pooled sensitivity of 0.81 (95% CI 0.64-0.91) and specificity of 0.91 (95% CI 0.87-0.94). The most sensitive cutoff for the GDS-15 was 5 at 0.91 (95% CI 0.83-1.00). The Beck Depression Inventory I/Ia had a pooled sensitivity of 0.79 (95% CI 0.61-0.90) and specificity of 0.85 (95% CI 0.79-0.90). The Montgomery-Åsberg Depression Rating Scale yielded a pooled sensitivity of 0.77 (95% CI 0.69-0.83) and specificity of 0.92 (95% CI 0.79-0.97). The Unified Parkinson's Disease Rating Scale had a pooled sensitivity of 0.72 (95% CI 0.64-0.79) and specificity of 0.80 (95% CI 0.70-0.87). All estimates had heterogeneity. CONCLUSIONS: There are several valid tools for detecting depression in patients with PD. Practitioners should choose one that fits their clinical practice.