RESUMEN
Research teams are increasingly interested in using cluster randomized trial (CRT) designs to generate practice-guiding evidence for in-center maintenance hemodialysis. However, CRTs raise complex ethical issues. The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials, published in 2012, provides 15 recommendations to address ethical issues arising within 7 domains: justifying the CRT design, research ethics committee review, identifying research participants, obtaining informed consent, gatekeepers, assessing benefits and harms, and protecting vulnerable participants. But applying the Ottawa Statement recommendations to CRTs in the hemodialysis setting is complicated by the unique features of the setting and population. Here, with the help of content experts and patient partners, we co-developed this implementation guidance document to provide research teams, research ethics committees, and other stakeholders with detailed guidance on how to apply the Ottawa Statement recommendations to CRTs in the hemodialysis setting, the result of a 4-year research project. Thus, our work demonstrates how the voices of patients, caregivers, and all stakeholders may be included in the development of research ethics guidance.
Asunto(s)
Consentimiento Informado , Proyectos de Investigación , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto , Diálisis Renal , Ética en InvestigaciónRESUMEN
BACKGROUND: Dexmedetomidine is increasingly used for surgical patients requiring general anaesthesia. However, its effectiveness on patient-centred outcomes remains uncertain. Our main objective was to evaluate the patient-centred effectiveness of intraoperative dexmedetomidine for adult patients requiring surgery under general anaesthesia. METHODS: We conducted a systematic search of MEDLINE, Embase, CENTRAL, Web of Science, and CINAHL from inception to October 2023. Randomised controlled trials (RCTs) comparing intraoperative use of dexmedetomidine with placebo, opioid, or usual care in adult patients requiring surgery under general anaesthesia were included. Study selection, data extraction, and risk of bias assessment were performed by two reviewers independently. We synthesised data using a random-effects Bayesian regression framework to derive effect estimates and the probability of a clinically important effect. For continuous outcomes, we pooled instruments with similar constructs using standardised mean differences (SMDs) and converted SMDs and credible intervals (CrIs) to their original scale when appropriate. We assessed the certainty of evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology. Our primary outcome was quality of recovery after surgery. To guide interpretation on the original scale, the Quality of Recovery-15 (QoR-15) instrument was used (range 0-150 points, minimally important difference [MID] of 6 points). RESULTS: We identified 49,069 citations, from which 44 RCTs involving 5904 participants were eligible. Intraoperative dexmedetomidine administration was associated with improvement in postoperative QoR-15 (mean difference 9, 95% CrI 4-14, n=21 RCTs, moderate certainty of evidence). We found 99% probability of any benefit and 88% probability of achieving the MID. There was a reduction in chronic pain incidence (odds ratio [OR] 0.42, 95% CrI 0.19-0.79, n=7 RCTs, low certainty of evidence). There was also increased risk of clinically significant hypotension (OR 1.98, 95% CrI 0.84-3.92, posterior probability of harm 94%, n=8 RCTs) and clinically significant bradycardia (OR 1.74, 95% CrI 0.93-3.34, posterior probability of harm 95%, n=10 RCTs), with very low certainty of evidence for both. There was limited evidence to inform other secondary patient-centred outcomes. CONCLUSIONS: Compared with placebo or standard of care, intraoperative dexmedetomidine likely results in meaningful improvement in the quality of recovery and chronic pain after surgery. However, it might increase clinically important bradycardia and hypotension. SYSTEMATIC REVIEW PROTOCOL: PROSPERO (CRD42023439896).
Asunto(s)
Teorema de Bayes , Dexmedetomidina , Dexmedetomidina/uso terapéutico , Humanos , Anestesia General/métodos , Atención Dirigida al Paciente , Hipnóticos y Sedantes/uso terapéutico , Ensayos Clínicos Controlados Aleatorios como Asunto , Resultado del Tratamiento , Dolor Postoperatorio/tratamiento farmacológico , Analgésicos no Narcóticos/uso terapéuticoRESUMEN
BACKGROUND: Postoperative patient-centred outcome measures are essential to capture the patient's experience after surgery. Although a large number of pharmacologic opioid minimisation strategies (i.e. opioid alternatives) are used for patients undergoing surgery, it remains unclear which strategies are most promising in terms of patient-centred outcome improvements. This scoping review had two main objectives: (1) to map and describe evidence from clinical trials assessing the patient-centred effectiveness of pharmacologic intraoperative opioid minimisation strategies in adult surgical patients, and (2) to identify promising pharmacologic opioid minimisation strategies. METHODS: We searched MEDLINE, Embase, CENTRAL, Web of Science, and CINAHL databases from inception to February 2023. We included trials investigating the use of opioid minimisation strategies in adult surgical patients and reporting at least one patient-centred outcome. Study screening and data extraction were conducted independently by at least two reviewers. RESULTS: Of 24,842 citations screened for eligibility, 2803 trials assessed the effectiveness of intraoperative opioid minimisation strategies. Of these, 457 trials (67,060 participants) met eligibility criteria, reporting at least one patient-centred outcome. In the 107 trials that included a patient-centred primary outcome, patient wellbeing was the most frequently used domain (55 trials). Based on aggregate findings, dexmedetomidine, systemic lidocaine, and COX-2 inhibitors were promising strategies, while paracetamol, ketamine, and gabapentinoids were less promising. Almost half of the trials (253 trials) did not report a protocol or registration number. CONCLUSIONS: Researchers should prioritise and include patient-centred outcomes in the assessment of opioid minimisation strategy effectiveness. We identified three potentially promising pharmacologic intraoperative opioid minimisation strategies that should be further assessed through systematic reviews and multicentre trials. Findings from our scoping review may be influenced by selective outcome reporting bias. STUDY REGISTRATION: OSF - https://osf.io/7kea3.
Asunto(s)
Analgésicos Opioides , Lidocaína , Adulto , Humanos , Analgésicos Opioides/uso terapéutico , Evaluación de Resultado en la Atención de SaludRESUMEN
Advance consent presents a potential solution to the challenge of obtaining informed consent for participation in acute stroke trials. Clinicians in stroke prevention clinics are uniquely positioned to identify and seek consent from potential stroke trial participants. To assess the acceptability of advance consent to Canadian stroke clinic physicians, we performed an online survey. We obtained 58 respondents (response rate 35%): the vast majority (82%) expressed comfort with obtaining advance consent and 92% felt that doing so would not be a significant disruption to clinic workflow. These results support further study of advance consent for acute stroke trials.
Asunto(s)
Médicos , Accidente Cerebrovascular , Humanos , Consentimiento Informado , Canadá , Accidente Cerebrovascular/terapia , Encuestas y CuestionariosRESUMEN
Advance consent could allow individuals at high risk of stroke to provide consent before they might become eligible for enrollment in acute stroke trials. This survey explores the acceptability of this novel technique to Canadian Research Ethics Board (REB) chairs that review acute stroke trials. Responses from 15 REB chairs showed that majority of respondents expressed comfort approving studies that adopt advance consent. There was no clear preference for advance consent over deferral of consent, although respondents expressed significant concern with broad rather than trial-specific advance consent. These findings shed light on the acceptability of advance consent to Canadian ethics regulators.
Asunto(s)
Ética en Investigación , Accidente Cerebrovascular , Humanos , Canadá , Encuestas y Cuestionarios , Accidente Cerebrovascular/terapia , Consentimiento InformadoRESUMEN
BACKGROUND: An integral aspect of patient engagement in research, also known as patient and public involvement, is appropriately recognising patient partners for their contributions through compensation (e.g., coauthorship, honoraria). Despite known benefits to compensating patient partners, our previous work suggested compensation is rarely reported and researchers perceive a lack of guidance on this issue. To address this gap, we identified and summarised available guidance and policy documents for patient partner compensation. METHODS: We conducted this scoping review in accordance with methods suggested by the JBI. We searched the grey literature (Google, Google Scholar) in March 2022 and Overton (an international database of policy documents) in April 2022. We included articles, guidance or policy documents regarding the compensation of patient partners for their research contributions. Two reviewers independently extracted and synthesised document characteristics and recommendations. RESULTS: We identified 65 guidance or policy documents. Most documents were published in Canada (57%, n = 37) or the United Kingdom (26%, n = 17). The most common recommended methods of nonfinancial compensation were offering training opportunities to patient partners (40%, n = 26) and facilitating patient partner attendance at conferences (38%, n = 25). The majority of guidance documents (95%) suggested financially compensating (i.e., offering something of monetary value) patient partners for their research contributions. Across guidance documents, the recommended monetary value of financial compensation was relatively consistent and associated with the role played by patient partners and/or specific engagement activities. For instance, the median monetary value for obtaining patient partner feedback (i.e., consultation) was $19/h (USD) (range of $12-$50/h). We identified several documents that guide the compensation of specific populations, including youth and Indigenous peoples. CONCLUSION: Multiple publicly available resources exist to guide researchers, patient partners and institutions in developing tailored patient partner compensation strategies. Our findings challenge the perception that a lack of guidance hinders patient partner financial compensation. Future efforts should prioritise the effective implementation of these compensation strategies to ensure that patient partners are appropriately recognised. PATIENT OR PUBLIC CONTRIBUTIONS: The patient partner coauthor informed protocol development, identified data items, and interpreted findings.
Asunto(s)
Participación del Paciente , Humanos , Guías como Asunto , Compensación y ReparaciónRESUMEN
INTRODUCTION: Children with chronic conditions have greater health care needs than the general paediatric population but may not receive care that centres their needs and preferences as identified by their families. Clinicians and researchers are interested in developing interventions to improve family-centred care need information about the characteristics of existing interventions, their development and the domains of family-centred care that they address. We conducted a scoping review that aimed to identify and characterize recent family-centred interventions designed to improve experiences with care for children with chronic conditions. METHODS: We searched Medline, Embase, PsycInfo and Cochrane databases, and grey literature sources for relevant articles or documents published between 1 January 2019 and 11 August 2020 (databases) or 7-20 October 2020 (grey literature). Primary studies with ≥10 participants, clinical practice guidelines and theoretical articles describing family-centred interventions that aimed to improve experiences with care for children with chronic conditions were eligible. Following citation and full-text screening by two reviewers working independently, we charted data covering study characteristics and interventions from eligible reports and synthesized interventions by domains of family-centred care. RESULTS: Our search identified 2882 citations, from which 63 articles describing 61 unique interventions met the eligibility criteria and were included in this review. The most common study designs were quasiexperimental studies (n = 18), randomized controlled trials (n = 11) and qualitative and mixed-methods studies (n = 9 each). The most frequently addressed domains of family-centred care were communication and information provision (n = 45), family involvement in care (n = 37) and access to care (n = 30). CONCLUSION: This review, which identified 61 unique interventions aimed at improving family-centred care for children with chronic conditions across a range of settings, is a concrete resource for researchers, health care providers and administrators interested in improving care for this high-needs population. PATIENT OR PUBLIC CONTRIBUTION: This study was co-developed with three patient partner co-investigators, all of whom are individuals with lived experiences of rare chronic diseases as parents and/or patients and have prior experience in patient engagement in research (I. J., N. P., M. S.). These patient partner co-investigators contributed to this study at all stages, from conceptualization to dissemination.
Asunto(s)
Atención Dirigida al Paciente , Humanos , Enfermedad Crónica/terapia , Niño , FamiliaRESUMEN
BACKGROUND: While red blood cell (RBC) transfusions are frequently administered during surgery, little is known about patient perspectives regarding intraoperative transfusion. The aim of this study was to understand patient perspectives about intraoperative RBC transfusion and explore their willingness to engage in transfusion prevention strategies. STUDY DESIGN AND METHODS: This descriptive qualitative study used semi-structured patient interviews before and after surgery. Purposive sampling was used to select adult patients with varying perioperative courses, including having perioperative transfusion or postoperative anemia. Inductive and deductive thematic analyses were conducted to identify themes. RESULTS: Twenty patients (nine preoperative and 11 postoperative patients) were interviewed. The following themes were identified: Risk-benefit perception of transfusion, transfusion acceptance, trust, patient involvement in transfusion decisions, acceptance of transfusion prevention interventions, and communication. Patients perceived transfusions as low-risk compared to the surgery itself. Factors influencing transfusion acceptance included trust in the healthcare system and the perception of the treatability of transfusion-related complications. Some patients preferred to defer transfusion decision making to the perioperative team, citing trust in professional judgment and building a positive relationship with their surgeon. Others wished for their preferences to be incorporated into transfusion decisions. Some desired detailed blood consent conversations and most were willing to participate in strategies to reduce intraoperative transfusion. CONCLUSION: In our sample, patients consider intraoperative transfusions as low-risk high-reward interventions and trust the healthcare system and perioperative team to guide intraoperative transfusion decision making. However, preoperative transfusion consent discussions were recalled as being superficial and lacking nuance. Targeted strategies are required to improve blood consent discussions to better integrate patient preferences.
Asunto(s)
Anemia , Transfusión Sanguínea , Adulto , Humanos , Anemia/etiología , Transfusión de Eritrocitos/efectos adversos , Medición de Riesgo , Estudios RetrospectivosRESUMEN
BACKGROUND: Addressing persistent and pervasive health inequities is a global moral imperative, which has been highlighted and magnified by the societal and health impacts of the COVID-19 pandemic. Observational studies can aid our understanding of the impact of health and structural oppression based on the intersection of gender, race, ethnicity, age and other factors, as they frequently collect this data. However, the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guideline, does not provide guidance related to reporting of health equity. The goal of this project is to develop a STROBE-Equity reporting guideline extension. METHODS: We assembled a diverse team across multiple domains, including gender, age, ethnicity, Indigenous background, disciplines, geographies, lived experience of health inequity and decision-making organizations. Using an inclusive, integrated knowledge translation approach, we will implement a five-phase plan which will include: (1) assessing the reporting of health equity in published observational studies, (2) seeking wide international feedback on items to improve reporting of health equity, (3) establishing consensus amongst knowledge users and researchers, (4) evaluating in partnership with Indigenous contributors the relevance to Indigenous peoples who have globally experienced the oppressive legacy of colonization, and (5) widely disseminating and seeking endorsement from relevant knowledge users. We will seek input from external collaborators using social media, mailing lists and other communication channels. DISCUSSION: Achieving global imperatives such as the Sustainable Development Goals (e.g., SDG 10 Reduced inequalities, SDG 3 Good health and wellbeing) requires advancing health equity in research. The implementation of the STROBE-Equity guidelines will enable a better awareness and understanding of health inequities through better reporting. We will broadly disseminate the reporting guideline with tools to enable adoption and use by journal editors, authors, and funding agencies, using diverse strategies tailored to specific audiences.
Asunto(s)
Inequidades en Salud , Estudios Observacionales como Asunto , Justicia Social , Humanos , COVID-19 , Pandemias , Proyectos de Investigación , Desarrollo Sostenible , Pueblos IndígenasRESUMEN
BACKGROUND AND AIMS: We need more pragmatic trials of interventions to improve care and outcomes for people living with Alzheimer's disease and related dementias. However, these trials present unique methodological challenges in their design, analysis, and reporting-often, due to the presence of one or more sources of clustering. Failure to account for clustering in the design and analysis can lead to increased risks of Type I and Type II errors. We conducted a review to describe key methodological characteristics and obtain a "baseline assessment" of methodological quality of pragmatic trials in dementia research, with a view to developing new methods and practical guidance to support investigators and methodologists conducting pragmatic trials in this field. METHODS: We used a published search filter in MEDLINE to identify trials more likely to be pragmatic and identified a subset that focused on people living with Alzheimer's disease or other dementias or included them as a defined subgroup. Pairs of reviewers extracted descriptive information and key methodological quality indicators from each trial. RESULTS: We identified N = 62 eligible primary trial reports published across 36 different journals. There were 15 (24%) individually randomized, 38 (61%) cluster randomized, and 9 (15%) individually randomized group treatment designs; 54 (87%) trials used repeated measures on the same individual and/or cluster over time and 17 (27%) had a multivariate primary outcome (e.g. due to measuring an outcome on both the patient and their caregiver). Of the 38 cluster randomized trials, 16 (42%) did not report sample size calculations accounting for the intracluster correlation and 13 (34%) did not account for intracluster correlation in the analysis. Of the 9 individually randomized group treatment trials, 6 (67%) did not report sample size calculations accounting for intracluster correlation and 8 (89%) did not account for it in the analysis. Of the 54 trials with repeated measurements, 45 (83%) did not report sample size calculations accounting for repeated measurements and 19 (35%) did not utilize at least some of the repeated measures in the analysis. No trials accounted for the multivariate nature of their primary outcomes in sample size calculation; only one did so in the analysis. CONCLUSION: There is a need and opportunity to improve the design, analysis, and reporting of pragmatic trials in dementia research. Investigators should pay attention to the potential presence of one or more sources of clustering. While methods for longitudinal and cluster randomized trials are well developed, accessible resources and new methods for dealing with multiple sources of clustering are required. Involvement of a statistician with expertise in longitudinal and clustered designs is recommended.
Asunto(s)
Enfermedad de Alzheimer , Ensayos Clínicos Pragmáticos como Asunto , Enfermedad de Alzheimer/terapia , Cuidadores , Análisis por Conglomerados , Humanos , Ensayos Clínicos Pragmáticos como Asunto/métodos , Ensayos Clínicos Controlados Aleatorios como Asunto , Proyectos de Investigación , Informe de InvestigaciónRESUMEN
OBJECTIVES: To describe reporting of informed consent in pragmatic trials, justifications for waivers of consent and reporting of alternative approaches to standard written consent. To identify factors associated with (1) not reporting and (2) not obtaining consent. METHODS: Survey of primary trial reports, published 2014-2019, identified using an electronic search filter for pragmatic trials implemented in MEDLINE, and registered in ClinicalTrials.gov. RESULTS: Among 1988 trials, 132 (6.6%) did not include a statement about participant consent, 1691 (85.0%) reported consent had been obtained, 139 (7.0%) reported a waiver and 26 (1.3%) reported consent for one aspect (eg, data collection) but a waiver for another (eg, intervention). Of the 165 trials reporting a waiver, 76 (46.1%) provided a justification. Few (53, 2.9%) explicitly reported use of alternative approaches to consent. In multivariable logistic regression analyses, lower journal impact factor (p=0.001) and cluster randomisation (p<0.0001) were significantly associated with not reporting on consent, while trial recency, cluster randomisation, higher-income country settings, health services research and explicit labelling as pragmatic were significantly associated with not obtaining consent (all p<0.0001). DISCUSSION: Not obtaining consent seems to be increasing and is associated with the use of cluster randomisation and pragmatic aims, but neither cluster randomisation nor pragmatism are currently accepted justifications for waivers of consent. Rather than considering either standard written informed consent or waivers of consent, researchers and research ethics committees could consider alternative consent approaches that may facilitate the conduct of pragmatic trials while preserving patient autonomy and the public's trust in research.
RESUMEN
BACKGROUND: Novel rationales for randomizing clusters rather than individuals appear to be emerging from the push for more pragmatic trials, for example, to facilitate trial recruitment, reduce the costs of research, and improve external validity. Such rationales may be driven by a mistaken perception that choosing cluster randomization lessens the need for informed consent. We reviewed a random sample of published cluster randomized trials involving only individual-level health care interventions to determine (a) the prevalence of reporting a rationale for the choice of cluster randomization; (b) the types of explicit, or if absent, apparent rationales for the use of cluster randomization; (c) the prevalence of reporting patient informed consent for study interventions; and (d) the types of justifications provided for waivers of consent. We considered cluster randomized trials for evaluating exclusively the individual-level health care interventions to focus on clinical trials where individual randomization is only theoretically possible and where there is a general expectation of informed consent. METHODS: A random sample of 40 cluster randomized trials were identified by implementing a validated electronic search filter in two electronic databases (Ovid MEDLINE and Embase), with two reviewers independently extracting information from each trial. Inclusion criteria were the following: primary report of a cluster randomized trial, evaluating exclusively an individual-level health care intervention, published between 2007 and 2016, and conducted in Canada, the United States, European Union, Australia, or low- and middle-income country settings. RESULTS: Twenty-five trials (62.5%, 95% confidence interval = 47.5%-77.5%) reported an explicit rationale for the use of cluster randomization. The most commonly reported rationales were those with logistical or administrative convenience (15 trials, 60%) and those that need to avoid contamination (13 trials, 52%); five trials (20%) were cited rationales related to the push for more pragmatic trials. Twenty-one trials (52.5%, 95% confidence interval = 37%-68%) reported written informed consent for the intervention, two (5%) reported verbal consent, and eight (20%) reported waivers of consent, while in nine trials (22.5%) consent was unclear or not mentioned. Reported justifications for waivers of consent included that study interventions were already used in clinical practice, patients were not randomized individually, and the need to facilitate the pragmatic nature of the trial. Only one trial reported an explicit and appropriate justification for waiver of consent based on minimum criteria in international research ethics guidelines, namely, infeasibility and minimal risk. CONCLUSION: Rationales for adopting cluster over individual randomization and for adopting consent waivers are emerging, related to the need to facilitate pragmatic trials. Greater attention to clear reporting of study design rationales, informed consent procedures, as well as justification for waivers is needed to ensure that such trials meet appropriate ethical standards.
Asunto(s)
Consentimiento Informado/ética , Ensayos Clínicos Controlados Aleatorios como Asunto/ética , Proyectos de Investigación , Australia , Canadá , Análisis por Conglomerados , Ética en Investigación , Europa (Continente) , Humanos , Consentimiento Informado/estadística & datos numéricos , Ensayos Clínicos Pragmáticos como Asunto/ética , Prevalencia , Ensayos Clínicos Controlados Aleatorios como Asunto/estadística & datos numéricos , Estados UnidosRESUMEN
This Viewpoint discusses the need to include patient and health care professional perspectives in the design of clinical trials to improve trial features and implementation.
Asunto(s)
Ensayos Clínicos como Asunto , Humanos , Personal de Salud , Participación del PacienteRESUMEN
Most newborns undergo newborn screening blood tests. Breastfeeding, skin-to-skin care, and sweet solutions effectively reduce pain; however, these strategies are inconsistently used. We conducted a 2-armed pilot randomized controlled trial in a mother-baby unit to examine the feasibility and acceptability of a parent-targeted and -mediated video demonstrating use of these pain-reducing strategies and to obtain preliminary effectiveness data on uptake of pain management. One hundred parent-newborn dyads were randomized to view the video or receive usual care (51 intervention and 49 control arm). Consent and attrition rates were 70% and 1%, respectively. All participants in the intervention arm received the intervention as planned and reported an intention to recommend the video and to use at least 1 pain treatment with breastfeeding or skin-to-skin care preferred over sucrose. In the intervention arm, 60% of newborns received at least 1 pain treatment compared with 67% in the control arm (absolute difference, -7%; 95% confidence interval, -26 to 12). The video was well accepted and feasible to show to parents. As there was no evidence of effect on the use of pain management, major modifications are required before launching a full-scale trial. Effective means to translate evidence-based pain knowledge is warranted.
Asunto(s)
Tamizaje Neonatal/efectos adversos , Manejo del Dolor/métodos , Dimensión del Dolor , Dolor/prevención & control , Padres/educación , Adulto , Ansiedad/prevención & control , Análisis por Conglomerados , Femenino , Humanos , Lactante , Recién Nacido , Masculino , Tamizaje Neonatal/métodos , Ontario , Dolor/etiología , Padres/psicología , Proyectos Piloto , Valores de Referencia , Edulcorantes/administración & dosificación , Centros de Atención Terciaria , Grabación en VideoRESUMEN
OBJECTIVE: To synthesize and describe parental expectations on how healthcare professionals should interact with them during a peripartum, antenatal consultation for extremely preterm infants. STUDY DESIGN: For this systematic literature review with textual narrative synthesis, we included studies that explored parental perspectives regarding the antenatal consultation for an extremely preterm infant. Electronic searches of Medline, CINAHL, PsycInfo, and Embase were conducted, along with a search of the grey literature. Quality appraisal was conducted using the guide by Walsh and Downe. Two independent reviewers reviewed 783 titles, of which 130 abstracts then 40 full-text articles were reviewed. Final data abstraction includes 19 studies. We predetermined 6 topics of interest (setting, timing, preferred healthcare professional, information, resources, and parents-physician interaction) to facilitate thematic analysis. RESULTS: In consideration of the variability of parents' specific desires, six predetermined topics and additional overarching themes such as perception of support, degree of understanding, hope, spirituality, and decision-making influences emerged. Studies suggest the quality of the antenatal consultation is not purely about information content, but also the manner in which it is provided. Limitations include thematic analysis that can potentially lead to the exclusion of important nuances. Relevant studies may have been missed if published outside the healthcare literature. CONCLUSIONS: The findings may inform clinical practice guidelines. This paper includes suggested strategies related to parents' perspectives that may facilitate communication during antenatal consultation for an extremely preterm infant. These strategies may also support parental engagement and satisfaction.
Asunto(s)
Comunicación , Toma de Decisiones , Enfermedades del Recién Nacido/diagnóstico , Femenino , Personal de Salud , Humanos , Recien Nacido Extremadamente Prematuro , Recién Nacido , Masculino , Padres , Educación del Paciente como Asunto , Participación del Paciente , Satisfacción del Paciente , Guías de Práctica Clínica como Asunto , Embarazo , Atención Prenatal , Relaciones Profesional-Paciente , Investigación CualitativaRESUMEN
BACKGROUND: Randomized controlled trial (RCT) trial designs exist on an explanatory-pragmatic spectrum, depending on the degree to which a study aims to address a question of efficacy or effectiveness. As conceptualized by Schwartz and Lellouch in 1967, an explanatory approach to trial design emphasizes hypothesis testing about the mechanisms of action of treatments under ideal conditions (efficacy), whereas a pragmatic approach emphasizes testing effectiveness of two or more available treatments in real-world conditions. Interest in, and the number of, pragmatic trials has grown substantially in recent years, with increased recognition by funders and stakeholders worldwide of the need for credible evidence to inform clinical decision-making. This increase has been accompanied by the onset of learning healthcare systems, as well as an increasing focus on patient-oriented research. However, pragmatic trials have ethical challenges that have not yet been identified or adequately characterized. The present study aims to explore the views of key stakeholders with respect to ethical issues raised by the design and conduct of pragmatic trials. It is embedded within a large, four-year project that seeks to develop guidance for the ethical design and conduct of pragmatic trials. As a first step, this study will address important gaps in the current empirical literature with respect to identifying a comprehensive range of ethical issues arising from the design and conduct of pragmatic trials. By opening up a broad range of topics for consideration within our parallel ethical analysis, we will extend the current debate, which has largely emphasized issues of consent, to the range of ethical considerations that may flow from specific design choices. METHODS: Semi-structured interviews with key stakeholders (e.g. trialists, methodologists, lay members of study teams, bioethicists, and research ethics committee members), across multiple jurisdictions, identified based on their known experience and/or expertise with pragmatic trials. DISCUSSION: We expect that the study outputs will be of interest to a wide range of knowledge users including trialists, ethicists, research ethics committees, journal editors, regulators, healthcare policymakers, research funders and patient groups. All publications will adhere to the Tri-Agency Open Access Policy on Publications.
Asunto(s)
Actitud del Personal de Salud , Ensayos Clínicos Pragmáticos como Asunto/ética , Protocolos Clínicos , Humanos , Entrevistas como Asunto , Ensayos Clínicos Pragmáticos como Asunto/métodos , Ensayos Clínicos Controlados Aleatorios como Asunto/ética , Ensayos Clínicos Controlados Aleatorios como Asunto/métodos , Proyectos de Investigación , Investigadores/psicologíaRESUMEN
To assess the reach, acceptability, and effect of the BSweet2Babies video showing breast-feeding, skin-to-skin care, and sucrose during blood sampling on intention to recommend the video or advocate for use of the interventions. In July 2014, the video and an electronic survey were produced and posted. After 1 year, the online viewer survey responses and YouTube analytics were analyzed. One year after posting, the BSweet2Babies video had 10 879 views from 125 countries and 187 (1.7%) viewers completed the survey. Most respondents were aware of the analgesic effects of breast-feeding, skin-to-skin care, and sucrose. Nearly all respondents (n = 158, 92%) found the BSweet2Babies video to be a helpful resource and 146 (84%) answered that they would recommend the video to others. After viewing the video, 183 (98%) respondents answered that they would advocate for 1 or more of the interventions. The BSweet2Babies video showing effective pain treatment during blood sampling had a large reach but a very small response rate for the survey. Therefore, analysis of acceptability and effect on intention to recommend the video and advocate for the interventions depicted are limited. Further research is warranted to explore how to best evaluate videos delivered through social media and to determine the effect of the video to promote knowledge translation into clinical practice.
Asunto(s)
Tamizaje Neonatal/efectos adversos , Manejo del Dolor/métodos , Dolor Asociado a Procedimientos Médicos/diagnóstico , Flebotomía/efectos adversos , Grabación en Video , Canadá , Estudios de Cohortes , Femenino , Humanos , Recién Nacido , Masculino , Tamizaje Neonatal/métodos , Dolor Asociado a Procedimientos Médicos/prevención & control , Flebotomía/métodos , Estudios RetrospectivosRESUMEN
Improving the transparency and quality of reporting in biomedical research is considered ethically important; yet, this is often based on practical reasons such as the facilitation of peer review. Surprisingly, there has been little explicit discussion regarding the ethical obligations that underpin reporting guidelines. In this commentary, we suggest a number of ethical drivers for the improved reporting of research. These ethical drivers relate to researcher integrity as well as to the benefits derived from improved reporting such as the fair use of resources, minimizing risk of harms, and maximizing benefits. Despite their undoubted benefit to reporting completeness, questions remain regarding the extent to which reporting guidelines can influence processes beyond publication, including researcher integrity or the uptake of scientific research findings into policy or practice. Thus, we consider investigation on the effects of reporting guidelines an important step in providing evidence of their benefits.