Marco Zaccagnini, A. Bussières, A. West, J. Boruff, A. Thomas
Introduction Health care professionals are expected to embrace and enact the scholarly practitioner role. Scholarly practitioners demonstrate a lifelong commitment to excellence in practice through continuous learning, engagement in evidence-informed decision-making, contributions to scholarship, and knowledge translation. However, the specific features and requirements associated with this role are not uniform. The absence of well-defined and delineated conceptualizations of scholarly practice and the scarcity of empirical research on how scholarly practice is operationalized contribute to a lack of a shared understanding of this complex role. Aim The purpose of this scoping review is to map the breadth and depth of the literature on what is known about scholarly practice in licensed health care professionals. Methods Arksey and O’Malley’s 6-stage scoping review framework will be used to examine the breadth and depth of the literature on the definitions and conceptualizations of the scholar role in health care professionals. We will conduct a comprehensive search from inception to present in MEDLINE (Ovid), EMBASE (Ovid), and CINAHL using scholarly practitioner terms and related synonyms, including a grey literature search. Following a calibration exercise, two independent reviewers will screen retrieved papers for inclusion and extract relevant data. Included papers will: (i) explore, describe, or define scholarly practice, scholar or scholarly practitioner, and/or related concepts in the licensed health care professionals; (ii) be conceptual and/or theoretical in nature; (iii) use quantitative, qualitative, or mixed methodologies; and (iv) be published in English or French. Numeric and thematic analysis will characterize the data and address the research objectives.
{"title":"Features of scholarly practice in health care professionals: A scoping review protocol","authors":"Marco Zaccagnini, A. Bussières, A. West, J. Boruff, A. Thomas","doi":"10.29390/cjrt-2020-007","DOIUrl":"https://doi.org/10.29390/cjrt-2020-007","url":null,"abstract":"Introduction Health care professionals are expected to embrace and enact the scholarly practitioner role. Scholarly practitioners demonstrate a lifelong commitment to excellence in practice through continuous learning, engagement in evidence-informed decision-making, contributions to scholarship, and knowledge translation. However, the specific features and requirements associated with this role are not uniform. The absence of well-defined and delineated conceptualizations of scholarly practice and the scarcity of empirical research on how scholarly practice is operationalized contribute to a lack of a shared understanding of this complex role. Aim The purpose of this scoping review is to map the breadth and depth of the literature on what is known about scholarly practice in licensed health care professionals. Methods Arksey and O’Malley’s 6-stage scoping review framework will be used to examine the breadth and depth of the literature on the definitions and conceptualizations of the scholar role in health care professionals. We will conduct a comprehensive search from inception to present in MEDLINE (Ovid), EMBASE (Ovid), and CINAHL using scholarly practitioner terms and related synonyms, including a grey literature search. Following a calibration exercise, two independent reviewers will screen retrieved papers for inclusion and extract relevant data. Included papers will: (i) explore, describe, or define scholarly practice, scholar or scholarly practitioner, and/or related concepts in the licensed health care professionals; (ii) be conceptual and/or theoretical in nature; (iii) use quantitative, qualitative, or mixed methodologies; and (iv) be published in English or French. Numeric and thematic analysis will characterize the data and address the research objectives.","PeriodicalId":9533,"journal":{"name":"Canadian Journal of Respiratory Therapy: CJRT = Revue Canadienne de la Thérapie Respiratoire : RCTR","volume":"31 1","pages":"38 - 41"},"PeriodicalIF":0.0,"publicationDate":"2020-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86088311","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
A significant consequence of the COVID-19 pandemic is the shortage of medical equipment (e g , personal protection equipment) On 20 March 2020, the Government of Canada asked Canadian businesses and industrialists to help develop and manufacture supplementary health care supplies for health professionals Since the call, almost 3,000 companies have volunteered their engineering and manufacturing expertise, including their facilities, to produce medical equipment Some include clothing brands repurposing stock to provide medical gowns and sports manufacturers providing face shields Comparisons of this type of industry collaboration have been made to automobile companies' wartime efforts including Ford and GM to produce tanks and airplanes using their factories during World War II RRTs working directly with patients with COVID-19 have the firsthand experience and knowledge to be invaluable counsel for these companies on medical equipment requirements
{"title":"Unintended consequences of COVID-19: Opportunities for respiratory therapists’ involvement in developing respiratory-related technologies","authors":"P. McClurg, N. Moroz, Marco Zaccagnini","doi":"10.29390/cjrt-2020-032","DOIUrl":"https://doi.org/10.29390/cjrt-2020-032","url":null,"abstract":"A significant consequence of the COVID-19 pandemic is the shortage of medical equipment (e g , personal protection equipment) On 20 March 2020, the Government of Canada asked Canadian businesses and industrialists to help develop and manufacture supplementary health care supplies for health professionals Since the call, almost 3,000 companies have volunteered their engineering and manufacturing expertise, including their facilities, to produce medical equipment Some include clothing brands repurposing stock to provide medical gowns and sports manufacturers providing face shields Comparisons of this type of industry collaboration have been made to automobile companies' wartime efforts including Ford and GM to produce tanks and airplanes using their factories during World War II RRTs working directly with patients with COVID-19 have the firsthand experience and knowledge to be invaluable counsel for these companies on medical equipment requirements","PeriodicalId":9533,"journal":{"name":"Canadian Journal of Respiratory Therapy: CJRT = Revue Canadienne de la Thérapie Respiratoire : RCTR","volume":"24 1","pages":"35 - 37"},"PeriodicalIF":0.0,"publicationDate":"2020-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84407804","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
H. Al Mandhari, M. Finelli, Shiyi Chen, C. Tomlinson, M. Nonoyama
Background and objectives Extubation readiness testing (ERT) in the Neonatal Intensive Care Unit (NICU) is highly variable and lacking standardized criteria. To address this gap, an evidence-based, inter-professionally developed ERT protocol was implemented to assess effectiveness on extubation failure within 72 h and on duration of intubation (DOI). Methods A longitudinal retrospective chart review in a level III, fully outborn NICU, of intubated infants admitted 1-year prior (Group 1), and 1 year after implementation (Group 2). Patients were extubated if they passed a 2-stage ERT protocol (3 min continuous positive airway pressure (CPAP) followed by 7 min CPAP + pressure support). Descriptive, comparative statistics, and univariate and multiple logistic regression were completed on all patients and a ≤32 6/7 weeks subgroup (intubated at day-of-life 1); p < 0.05 is considered significant. Results All patients (n = 589 (n = 294 Group 1, n = 295 Group 2)) were included (preterm, intubated day of life one subgroup: n = 42 Group 1, n = 38 Group 2). For all patients, extubation failure decreased significantly from 9.9% to 4.1% (p = 0.006); Group 1 patients were 2.42 times more likely to experience extubation failure compared with Group 2. Extubation failure in the preterm subgroup decreased from 21.7% to 2.6% (p = 0.01); Group 1 patients were 10.71 times more likely to experience extubation failure. Median DOI was similar in both groups for all patients and in the preterm subgroup. Conclusions A unique two-stage ERT protocol was effective at reducing extubation failure rate, without increasing DOI, largely in preterm infants. The evidence-based, interprofessionally developed ERT protocol and its integration into the NICU culture largely contributed to its success.
{"title":"Effects of an extubation readiness test protocol at a tertiary care fully outborn neonatal intensive care unit","authors":"H. Al Mandhari, M. Finelli, Shiyi Chen, C. Tomlinson, M. Nonoyama","doi":"10.29390/cjrt-2019-011","DOIUrl":"https://doi.org/10.29390/cjrt-2019-011","url":null,"abstract":"Background and objectives Extubation readiness testing (ERT) in the Neonatal Intensive Care Unit (NICU) is highly variable and lacking standardized criteria. To address this gap, an evidence-based, inter-professionally developed ERT protocol was implemented to assess effectiveness on extubation failure within 72 h and on duration of intubation (DOI). Methods A longitudinal retrospective chart review in a level III, fully outborn NICU, of intubated infants admitted 1-year prior (Group 1), and 1 year after implementation (Group 2). Patients were extubated if they passed a 2-stage ERT protocol (3 min continuous positive airway pressure (CPAP) followed by 7 min CPAP + pressure support). Descriptive, comparative statistics, and univariate and multiple logistic regression were completed on all patients and a ≤32 6/7 weeks subgroup (intubated at day-of-life 1); p < 0.05 is considered significant. Results All patients (n = 589 (n = 294 Group 1, n = 295 Group 2)) were included (preterm, intubated day of life one subgroup: n = 42 Group 1, n = 38 Group 2). For all patients, extubation failure decreased significantly from 9.9% to 4.1% (p = 0.006); Group 1 patients were 2.42 times more likely to experience extubation failure compared with Group 2. Extubation failure in the preterm subgroup decreased from 21.7% to 2.6% (p = 0.01); Group 1 patients were 10.71 times more likely to experience extubation failure. Median DOI was similar in both groups for all patients and in the preterm subgroup. Conclusions A unique two-stage ERT protocol was effective at reducing extubation failure rate, without increasing DOI, largely in preterm infants. The evidence-based, interprofessionally developed ERT protocol and its integration into the NICU culture largely contributed to its success.","PeriodicalId":9533,"journal":{"name":"Canadian Journal of Respiratory Therapy: CJRT = Revue Canadienne de la Thérapie Respiratoire : RCTR","volume":"128 1","pages":"81 - 88"},"PeriodicalIF":0.0,"publicationDate":"2019-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80464203","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Introduction Respiratory Health Professionals (RHPs) with specialty training in the management of asthma and COPD, often care for patients with advanced respiratory disease, who have less access to palliative care than patients with similar disease burden. The aims of this study were to: (i) explore the current and desired roles of RHPs in terms of palliative care and (ii) examine barriers to discussions with patients about palliative care. Methods An online survey addressing the aims of this study was developed and pilot tested. The survey was distributed nationally using the database of the Lung Association’s RESPTREC respiratory educator training program. Descriptive statistics were performed. Results A total of 123 completed surveys were returned, with respiratory therapists comprising the largest group of respondents. The majority indicated that end-of-life care was less than optimal for patients with advanced respiratory illnesses and agreed that palliative care should be a role of RHPs. Patient- and family-related barriers to having end-of-life discussions included: difficulty accepting prognosis, limitations and complications, and lack of capacity. For providers, the most important barriers were: lack of training, uncertainty about prognosis, and lack of time. The health care system barriers of concern were increasing demand for palliative care services and limited accessibility of palliative care for those with advanced respiratory diseases and difficulties in accurate prognostication for these conditions. Discussion Incorporating a more defined role in palliative care was generally seen as a desirable evolution of the RHP role. A number of strategies to mitigate identified barriers to discussions with the patient are described. Better alignment of the services required with the needs of patients with advanced respiratory disease can be addressed in a number of ways. Conclusions As RHP roles continue to evolve, consideration should be given to the ways in which RHPs can contribute to improving the quality of care for patients with advanced respiratory disease. Building collaborations with RHPs, palliative care, and other existing health programs can ensure high quality of care. Creating and taking advantage of learning opportunities to build skills and comfort in using a palliative approach will benefit respiratory patients.
{"title":"Palliative care as an emerging role for respiratory health professionals: Findings from a cross-sectional, exploratory Canadian survey","authors":"D. Goodridge, Jaimie Peters","doi":"10.29390/cjrt-2019-010","DOIUrl":"https://doi.org/10.29390/cjrt-2019-010","url":null,"abstract":"Introduction Respiratory Health Professionals (RHPs) with specialty training in the management of asthma and COPD, often care for patients with advanced respiratory disease, who have less access to palliative care than patients with similar disease burden. The aims of this study were to: (i) explore the current and desired roles of RHPs in terms of palliative care and (ii) examine barriers to discussions with patients about palliative care. Methods An online survey addressing the aims of this study was developed and pilot tested. The survey was distributed nationally using the database of the Lung Association’s RESPTREC respiratory educator training program. Descriptive statistics were performed. Results A total of 123 completed surveys were returned, with respiratory therapists comprising the largest group of respondents. The majority indicated that end-of-life care was less than optimal for patients with advanced respiratory illnesses and agreed that palliative care should be a role of RHPs. Patient- and family-related barriers to having end-of-life discussions included: difficulty accepting prognosis, limitations and complications, and lack of capacity. For providers, the most important barriers were: lack of training, uncertainty about prognosis, and lack of time. The health care system barriers of concern were increasing demand for palliative care services and limited accessibility of palliative care for those with advanced respiratory diseases and difficulties in accurate prognostication for these conditions. Discussion Incorporating a more defined role in palliative care was generally seen as a desirable evolution of the RHP role. A number of strategies to mitigate identified barriers to discussions with the patient are described. Better alignment of the services required with the needs of patients with advanced respiratory disease can be addressed in a number of ways. Conclusions As RHP roles continue to evolve, consideration should be given to the ways in which RHPs can contribute to improving the quality of care for patients with advanced respiratory disease. Building collaborations with RHPs, palliative care, and other existing health programs can ensure high quality of care. Creating and taking advantage of learning opportunities to build skills and comfort in using a palliative approach will benefit respiratory patients.","PeriodicalId":9533,"journal":{"name":"Canadian Journal of Respiratory Therapy: CJRT = Revue Canadienne de la Thérapie Respiratoire : RCTR","volume":"5 1","pages":"73 - 80"},"PeriodicalIF":0.0,"publicationDate":"2019-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88681280","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Troy Ellens, R. Kaur, K. Roehl, Meagan N Dubosky, D. Vines
Introduction Weaning predictors can help liberate patients in a timely manner from mechanical ventilation. Ventilatory equivalent for oxygen (VEqO2), a surrogate for work of breathing and a measure of the efficiency of breathing, may be an important noninvasive alternative to other weaning predictors. Our study’s purpose was to observe any differences in VEqO2 between extubation outcome groups. Methods Employing a metabolic cart, oxygen consumption (V˙O2), minute volume (VE), tidal volume (VT), and breathing frequency were recorded during a spontaneous breathing trial (SBT) to calculate VEqO2 and the rapid shallow breathing index (RSBI) in 34 adult participants in the intensive care unit. Five-breath means of VEqO2 and the RSBI collected throughout the SBT were examined between SBT pass and fail groups and extubation pass and fail groups using the Mann–Whitney U test with p < 0.05. Results Data from 31 participants were analyzed between SBT outcome groups. Data from 20 participants were examined for extubation outcome after a successful SBT. Median (interquartile range) VEqO2 was not different between extubation groups. Participants who passed the SBT had a higher median VEqO2 than those who did not at the midpoint (25.3 L/L V˙O2 [22–33 L/L V˙O2] vs. 23.7 L/L V˙O2 [18–24 L/L V˙O2], p = 0.035) and at the end (25.5 L/L V˙O2 [23–34 L/L V˙O2] vs. 21.3 L/L V˙O2 [20–24 L/L V˙O2], p = 0.017) of the SBT. Discussion VEqO2 may show differences in SBT outcomes, but not differences between extubation outcomes. VEqO2 may be able to detect differences in work during an SBT, but may not be able to predict change in workload in the respiratory system after extubation. The small sample size may also have prevented any differences in extubation outcomes to be shown. Conclusion VEqO2 was higher in patients that passed their SBT. VEqO2 was not useful in identifying extubation success or failure in adult mechanically ventilated patients.
脱机预测可以帮助患者及时脱离机械通气。呼吸当量氧(VEqO2)作为呼吸功的替代指标和呼吸效率的衡量指标，可能是其他脱机预测指标的重要无创替代指标。我们研究的目的是观察拔管结果组之间VEqO2的差异。方法采用代谢车，记录34例重症监护病房成人患者自主呼吸试验(SBT)期间的耗氧量(V˙O2)、分气量(VE)、潮气量(VT)和呼吸频率，计算VEqO2和快速浅呼吸指数(RSBI)。采用Mann-Whitney U检验，比较SBT通过组和拔管通过组和拔管失败组之间VEqO2和RSBI的五次呼吸均值，p < 0.05。结果31名参与者的数据在SBT结果组之间进行了分析。来自20名参与者的数据被检查成功的SBT后拔管结果。拔管组间VEqO2中位数(四分位数范围)无差异。通过SBT的参与者在SBT中点(25.3 L/L V˙O2 [22-33 L/L V˙O2] vs. 23.7 L/L V˙O2 [18-24 L/L V˙O2]， p = 0.035)和结束时(25.5 L/L V˙O2 [23-34 L/L V˙O2] vs. 21.3 L/L V˙O2 [20-24 L/L V˙O2]， p = 0.017)的VEqO2中位数高于未通过SBT的参与者。VEqO2可能显示SBT结果的差异，但不显示拔管结果之间的差异。VEqO2可能能够检测SBT期间工作的差异，但可能无法预测拔管后呼吸系统工作量的变化。小样本量也可能阻止了拔管结果的任何差异。结论通过SBT的患者VEqO2较高。VEqO2在成人机械通气患者拔管成功或失败的判断中没有作用。
{"title":"Ventilatory equivalent for oxygen as an extubation outcome predictor: A pilot study","authors":"Troy Ellens, R. Kaur, K. Roehl, Meagan N Dubosky, D. Vines","doi":"10.29390/cjrt-2019-007","DOIUrl":"https://doi.org/10.29390/cjrt-2019-007","url":null,"abstract":"Introduction Weaning predictors can help liberate patients in a timely manner from mechanical ventilation. Ventilatory equivalent for oxygen (VEqO2), a surrogate for work of breathing and a measure of the efficiency of breathing, may be an important noninvasive alternative to other weaning predictors. Our study’s purpose was to observe any differences in VEqO2 between extubation outcome groups. Methods Employing a metabolic cart, oxygen consumption (V˙O2), minute volume (VE), tidal volume (VT), and breathing frequency were recorded during a spontaneous breathing trial (SBT) to calculate VEqO2 and the rapid shallow breathing index (RSBI) in 34 adult participants in the intensive care unit. Five-breath means of VEqO2 and the RSBI collected throughout the SBT were examined between SBT pass and fail groups and extubation pass and fail groups using the Mann–Whitney U test with p < 0.05. Results Data from 31 participants were analyzed between SBT outcome groups. Data from 20 participants were examined for extubation outcome after a successful SBT. Median (interquartile range) VEqO2 was not different between extubation groups. Participants who passed the SBT had a higher median VEqO2 than those who did not at the midpoint (25.3 L/L V˙O2 [22–33 L/L V˙O2] vs. 23.7 L/L V˙O2 [18–24 L/L V˙O2], p = 0.035) and at the end (25.5 L/L V˙O2 [23–34 L/L V˙O2] vs. 21.3 L/L V˙O2 [20–24 L/L V˙O2], p = 0.017) of the SBT. Discussion VEqO2 may show differences in SBT outcomes, but not differences between extubation outcomes. VEqO2 may be able to detect differences in work during an SBT, but may not be able to predict change in workload in the respiratory system after extubation. The small sample size may also have prevented any differences in extubation outcomes to be shown. Conclusion VEqO2 was higher in patients that passed their SBT. VEqO2 was not useful in identifying extubation success or failure in adult mechanically ventilated patients.","PeriodicalId":9533,"journal":{"name":"Canadian Journal of Respiratory Therapy: CJRT = Revue Canadienne de la Thérapie Respiratoire : RCTR","volume":"17 1","pages":"65 - 71"},"PeriodicalIF":0.0,"publicationDate":"2019-07-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77849463","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
We are pleased to present a select number of abstracts from the proceedings of the CSRT Annual Education Conference. Held in Niagara Falls, Ontario, May 9–11, 2019, this conference included topics delivered by international, national and regional individuals with expertise in various areas of respiratory therapy practice. As evidenced by the following abstracts, the work of our colleagues in 2019 highlighted current research and practice innovations led by RTs. We have made every effort to include all abstracts accepted by the Program Committee before the publication deadline; however, please note that this collection does not represent the entire program (available at www.csrt.com). The editorial board looks forward to receiving manuscripts from this conference for consideration for publication in the Canadian Journal of Respiratory Therapy to continue building the body of knowledge specific to our profession. Please note these abstracts have not been peer reviewed.
{"title":"Proceedings from the Canadian Society of Respiratory Therapists Annual Education Conference","authors":"","doi":"10.29390/cjrt-2019-006","DOIUrl":"https://doi.org/10.29390/cjrt-2019-006","url":null,"abstract":"We are pleased to present a select number of abstracts from the proceedings of the CSRT Annual Education Conference. Held in Niagara Falls, Ontario, May 9–11, 2019, this conference included topics delivered by international, national and regional individuals with expertise in various areas of respiratory therapy practice. As evidenced by the following abstracts, the work of our colleagues in 2019 highlighted current research and practice innovations led by RTs. We have made every effort to include all abstracts accepted by the Program Committee before the publication deadline; however, please note that this collection does not represent the entire program (available at www.csrt.com). The editorial board looks forward to receiving manuscripts from this conference for consideration for publication in the Canadian Journal of Respiratory Therapy to continue building the body of knowledge specific to our profession. Please note these abstracts have not been peer reviewed.","PeriodicalId":9533,"journal":{"name":"Canadian Journal of Respiratory Therapy: CJRT = Revue Canadienne de la Thérapie Respiratoire : RCTR","volume":"55 1","pages":"47 - 64"},"PeriodicalIF":0.0,"publicationDate":"2019-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85398531","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2013-01-01DOI: 10.1001/archpsyc.63.2.128
N. Tiffin, J. Nickerson
Over the past eight years, the registration of clinical trials has been strongly advocated by journals and editors, and is now considered to be mandatory for publication by most medical journals. In the United States, it became legally mandated by the Food and Drug Administration in 2007 (1), although Canada has no law requiring registration. Registration of a clinical trial ensures that the public has access to information regarding trials involving human subjects and health outcomes. Published clinical trials strongly affect decision making in health care, including decisions made at the bedside, in the boardroom and in the legislature. Therefore, the public needs to have access to the same evidence as the decision makers. Moreover, registering clinical trials and their protocols before data collection begins helps correct the distortion created by selective reporting in the literature (ie, ‘positive publication bias’), in which only trials with positive outcomes are published. Many also believe that the research community, by using human subjects, has a moral obligation to the public to publish their findings and a registry can reveal a disconnect in communication. In addition, registries can help standardize and improve clinical trial protocols, reduce overlapping or redundant publication and scientific misconduct, and improve accuracy in reporting. Several registries exist today, with the largest at administered by the US National Institutes of Health. Individual countries often have their own registry, many of which use the WHO’s International Clinical Trial Registry Platform guidelines. The International Committee of Medical Journal Editors has established six guidelines for the establishment of registries (2); although not all registries adhere to these guidelines, they provide insight to registry characteristics and expectations: Accessible to the public at no charge. Open to all prospective registrants. Managed by a not-for-profit organization. A mechanism to ensure the validity of the registration data must be available. Electronically searchable. Trial registration with missing fields or fields that contain uninformative terminology is inadequate. The International Committee of Medical Journal Editors defines a clinical trial as “any research project that prospectively assigns human subjects to intervention or concurrent comparison or control groups to study the cause-and-effect relationship between a medical intervention and a health outcome” (2). Health outcomes are further defined as “any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events” (3). In the current issue of the Canadian Journal of Respiratory Therapy, the study by Matthews and Fortier (4) (pages 11–14) – ‘The Rematee Bumper Belt positional therapy device for snoring and obstructive sleep apnea: Positional effectiveness in healthy subjects’ – ha
在过去的八年中，临床试验的注册一直受到期刊和编辑的强烈倡导，现在被认为是大多数医学期刊发表的强制性要求。在美国，2007年食品和药物管理局(Food and Drug Administration)在法律上强制要求(1)，尽管加拿大没有法律要求注册。临床试验的注册确保公众能够获得有关涉及人体受试者和健康结果的试验的信息。已发表的临床试验强烈地影响着医疗保健方面的决策，包括床边、董事会和立法机构的决策。因此，公众需要获得与决策者相同的证据。此外，在数据收集开始之前注册临床试验及其方案有助于纠正文献选择性报告造成的扭曲(即“积极发表偏倚”)，其中只发表具有积极结果的试验。许多人还认为，研究界通过使用人类受试者，对公众负有发表他们的发现的道德义务，而登记可以揭示沟通上的脱节。此外，注册可以帮助规范和改进临床试验方案，减少重叠或冗余的出版和科学不端行为，并提高报告的准确性。目前存在几个登记处，其中最大的由美国国立卫生研究院管理。个别国家通常有自己的注册中心，其中许多使用世卫组织的国际临床试验注册平台指南。国际医学期刊编辑委员会为建立登记制度制定了六项准则(2);尽管并非所有注册中心都遵循这些指导方针，但它们提供了对注册中心特征和期望的洞察:对公众免费开放。对所有潜在注册人开放。由非营利组织管理。必须有确保注册数据有效性的机制。电子搜索。缺少字段或包含无信息术语的字段的试验注册是不充分的。国际医学杂志编辑委员会将临床试验定义为“任何研究项目，将人类受试者分配到干预组或同时比较组或对照组，以研究医疗干预与健康结果之间的因果关系”(2)。健康结果进一步定义为“在患者或参与者身上获得的任何生物医学或健康相关措施，包括药代动力学测量和不良事件”(3)。在最新一期的《加拿大呼吸治疗杂志》上，Matthews和Fortier的研究(11-14页)——“Rematee保险杠带体位治疗打鼾和阻塞性睡眠呼吸暂停的装置:健康受试者的体位有效性”——尽管使用了人类受试者，但尚未注册为临床试验。为什么?首先，尽管《华尔街日报》的编辑委员会强烈支持临床试验的注册，但我们不相信这项研究的因变量——睡眠姿势——达到了健康结果的定义。此外，我们认为，由于注册的主要原因是为了确保重要发现的发表，并且作者已经提交了稿件供发表，因此这成为一个没有实际意义的标准。尽管《华尔街日报》坚信临床试验注册的价值，但我们认为，总的来说，仅仅因为缺乏临床试验注册而拒绝一篇报道已完成研究的文章并不符合患者和卫生保健提供者的最佳利益。在做出这一决定时，我们咨询了医学出版和临床试验注册方面的专家，并认为这是最合适的决定。随着期刊在声誉和质量方面的进步，我们预计会有更多的临床试验稿件提交，并且受到这篇特殊文章的启发，我们将编纂一项临床试验发表标准政策，该政策将于2014年发布。展望未来，我们强烈鼓励所有作者和研究者在进行数据收集之前前瞻性地注册他们的临床试验。我们打算将这些细节包括在临床试验手稿的出版中，以提高呼吸治疗研究的透明度和质量。
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Pub Date : 1900-01-01DOI: 10.4135/9781483346328.n93
D. Melvin, A. Markham
The Marihuana Medical Access Regulations define the circumstance and manner in which marihuana can be used for medical purposes by people who are suffering from grave and debilitating illnesses. The regulations describe how people can be authorized to possess and grow marijuana without legal penalty. These new regulations deal exclusively with the medical use of marijuana, not the issue of legalization.
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