Research methodology

研究方法
  • 文章类型: Letter
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  • 文章类型: Journal Article
    背景:深度访谈是定性数据收集的常用方法,提供关于个人的观念和行为的丰富数据,用定量方法收集这些数据将是具有挑战性的。研究人员通常需要事先决定样本量。尽管研究已经评估了何时达到饱和,对于达到饱和所需的最低采访次数没有达成一致。迄今为止,大多数关于饱和度的研究都是基于现场数据收集。在COVID-19大流行期间,基于网络的数据收集变得越来越普遍,因为传统的面对面数据收集是可能的。研究人员在COVID-19紧急情况后继续使用基于网络的数据收集方法,这使得重要的是评估饱和的结果是否在面对面采访和基于网络的采访中有所不同。
    目的:我们旨在确定实现真正代码饱和或接近代码饱和所需的基于网络的访谈数量。
    方法:本研究的分析基于5项食品和药物管理局资助的研究的数据,这些研究是通过基于网络的平台进行的,这些平台对患有潜在医疗状况的患者或对患者提供初级或专科护理的医疗保健提供者进行的。我们提取了特定于代码和访谈的数据,并检查数据摘要,以确定何时达到真正的饱和或接近饱和。
    结果:5项研究中使用的样本量范围为30至70次访谈。经过91%至100%(n=30-67)的计划面试后达到真正的饱和度,而在计划访谈的33%至60%(n=15-23)后达到接近饱和.严重依赖演绎编码的研究和具有更结构化访谈指南的研究更快地达到了真正的饱和和接近饱和。我们还检查了在达到接近饱和后应用的代码类型。在5项研究中的4项,这些代码中的大多数代表了以前建立的核心概念或主题。代表新确定的概念的代码,其他或杂项回应(例如,\"ingeneral\"),不确定性或困惑(例如,\“不知道\”),或用于分析的分类(例如,与不正确的相比,正确的)在达到接近饱和后较不常见。
    结论:这项研究提供了支持,即接近饱和可能是一个足够的指标,并且在这一点之后进行额外的访谈可能会导致收益递减。在决定进行多少次面试时要考虑的因素包括面试指南中包含的问题的结构和类型,编码结构,和正在研究的人口。具有较少的结构化面试指南的研究,严重依赖归纳编码和分析技术的研究,以及包括可能对所讨论主题了解较少的人群的研究可能需要更大的样本量才能达到可接受的饱和水平。我们的发现还建立在先前的研究基础上,这些研究着眼于在少数地点进行的现场数据收集的饱和度。
    BACKGROUND: In-depth interviews are a common method of qualitative data collection, providing rich data on individuals\' perceptions and behaviors that would be challenging to collect with quantitative methods. Researchers typically need to decide on sample size a priori. Although studies have assessed when saturation has been achieved, there is no agreement on the minimum number of interviews needed to achieve saturation. To date, most research on saturation has been based on in-person data collection. During the COVID-19 pandemic, web-based data collection became increasingly common, as traditional in-person data collection was possible. Researchers continue to use web-based data collection methods post the COVID-19 emergency, making it important to assess whether findings around saturation differ for in-person versus web-based interviews.
    OBJECTIVE: We aimed to identify the number of web-based interviews needed to achieve true code saturation or near code saturation.
    METHODS: The analyses for this study were based on data from 5 Food and Drug Administration-funded studies conducted through web-based platforms with patients with underlying medical conditions or with health care providers who provide primary or specialty care to patients. We extracted code- and interview-specific data and examined the data summaries to determine when true saturation or near saturation was reached.
    RESULTS: The sample size used in the 5 studies ranged from 30 to 70 interviews. True saturation was reached after 91% to 100% (n=30-67) of planned interviews, whereas near saturation was reached after 33% to 60% (n=15-23) of planned interviews. Studies that relied heavily on deductive coding and studies that had a more structured interview guide reached both true saturation and near saturation sooner. We also examined the types of codes applied after near saturation had been reached. In 4 of the 5 studies, most of these codes represented previously established core concepts or themes. Codes representing newly identified concepts, other or miscellaneous responses (eg, \"in general\"), uncertainty or confusion (eg, \"don\'t know\"), or categorization for analysis (eg, correct as compared with incorrect) were less commonly applied after near saturation had been reached.
    CONCLUSIONS: This study provides support that near saturation may be a sufficient measure to target and that conducting additional interviews after that point may result in diminishing returns. Factors to consider in determining how many interviews to conduct include the structure and type of questions included in the interview guide, the coding structure, and the population under study. Studies with less structured interview guides, studies that rely heavily on inductive coding and analytic techniques, and studies that include populations that may be less knowledgeable about the topics discussed may require a larger sample size to reach an acceptable level of saturation. Our findings also build on previous studies looking at saturation for in-person data collection conducted at a small number of sites.
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  • 文章类型: Editorial
    在计算方法发展的时候,通常与现在备受吹捧的机器学习(ML)和人工智能(AI)术语联系在一起,在公平方面面临越来越多的挑战,透明度和问责制,研究人员将主流ML方法应用于几乎任何类型的数据的诱惑似乎仍然无法抗拒。在本文中,我们批判性地研究了最近提出的将ML应用于测谎仪筛查结果的建议(其中人类采访者已经得出了关于欺骗的结论),这对研究的目的和设计提出了几个问题,特别是考虑到基于测谎仪的程序本身的空虚科学地位。我们认为,在刑事司法和就业实践等高风险环境中,在基本权利和正义原则受到威胁的地方,科学研究的法律和道德考虑得到了加强。具体来说,我们认为,模糊标记的数据和临时机器学习模型的组合不符合这一要求。更糟糕的是,这样的研究可能会不恰当地合法化,否则在科学上是无效的,实际上是伪科学方法,如基于测谎仪的欺骗检测,特别是当在一个著名的科学期刊上发表时。我们得出的结论是,方法论上的关注,如本文所强调的,在研究可以说有助于解决法律诉讼中使用的方法和技术的任何基本有效性问题之前,应该予以解决。
    At a time when developments in computational approaches, often associated with the now much-vaunted terms Machine Learning (ML) and Artificial Intelligence (AI), face increasing challenges in terms of fairness, transparency and accountability, the temptation for researchers to apply mainstream ML methods to virtually any type of data seems to remain irresistible. In this paper we critically examine a recent proposal to apply ML to polygraph screening results (where human interviewers have made a conclusion about deception), which raises several questions about the purpose and the design of the research, particularly given the vacuous scientific status of polygraph-based procedures themselves. We argue that in high-stake environments such as criminal justice and employment practice, where fundamental rights and principles of justice are at stake, the legal and ethical considerations for scientific research are heightened. Specifically, we argue that the combination of ambiguously labelled data and ad hoc ML models does not meet this requirement. Worse, such research can inappropriately legitimise otherwise scientifically invalid, indeed pseudo-scientific methods such as polygraph-based deception detection, especially when presented in a reputable scientific journal. We conclude that methodological concerns, such as those highlighted in this paper, should be addressed before research can be said to contribute to resolving any of the fundamental validity issues that underlie methods and techniques used in legal proceedings.
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  • 文章类型: Clinical Conference
    研究的基本概念是通过系统的文献检索学习的,这些文献构成了研究陈述和研究主题的基础。然后是研究问题,假设,目标,和目标,以及实验设计,是开发的。鉴于所提供的上下文,主要重点是在研究方法和项目开发方面充分培训研究生和年轻研究人员的重要性。显然,在这些方面缺乏适当的培训,印度大学的迅速扩张加剧了这个问题。为了解决这个问题,研究型学生必须接受全面的科研方法论指导,实验设计,统计数据,科学写作,出版,和研究伦理。我们的团队已经举办了二十多年的研讨会和座谈会,以改善这些领域的现有教学方法。最近,我们在印度多个州组织了一系列国家和国际研讨会,以巩固学生和教职员工的科学研究核心概念。本报告重点介绍了这些研讨会的关键方面以及参与者所取得的积极成果。
    The basic concepts of research are learned through systematic literature searches which form the basis of a research statement and research topic. Then the research question, hypothesis, aim, and objectives, as well as the experimental design, are developed. Given the context provided, the primary focus is on the importance of adequately training postgraduates and young research investigators in research methodology and project development. It is evident that there is a lack of proper training in these areas, and the rapid expansion of colleges in India exacerbates this issue. To address this, research students must receive comprehensive instruction in scientific research methodology, experimental design, statistics, scientific writing, publishing, and research ethics. Our team has been conducting workshops and symposia for more than two decades to improve the current teaching methods in these areas. Most recently, we organized a series of national and international workshops and seminars in multiple states across India to fortify the core concepts of scientific research for students and faculty members. This report highlights the key aspects of these workshops and the positive outcomes experienced by participants.
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  • 文章类型: English Abstract
    Criteria for assessment of the significance of scientific articles are presented. The focus is on research design and methodology, illustrated by the classical study on prehospital volume treatment of severely injured individuals with penetrating torso injuries by Bickell et al. (1994). A well-thought out research design is crucial for the success of a scientific study and is documented in a study protocol beforehand. A hypothesis is a provisional explanation or prediction and must be testable, falsifiable, precise, and relevant. There are various types of randomization methods, with the randomized controlled trial being the gold standard for clinical interventional studies. When reading a scientific article it is important to verify whether the research design and setting align with the research question and whether potential sources of error have been considered and controlled. Critical scrutiny should also be applied to references, the funding and expertise of the researchers.
    UNASSIGNED: Kriterien zur Einordnung der Aussagekraft wissenschaftlicher Artikel werden vorgestellt. Der Fokus liegt auf Forschungsdesign und Methodik, die anhand der klassischen Studie zur prähospitalen Volumentherapie bei Schwerverletzten mit penetrierenden Torsoverletzungen von Bickell et al. (1994) erläutert werden. Ein sorgfältig durchdachtes Forschungsdesign entscheidet über den Erfolg einer wissenschaftlichen Studie und wird vorab im Studienprotokoll festgehalten. Eine Hypothese ist eine vorläufige Erklärung oder Vorhersage und muss test-, falsifizierbar, präzise und relevant sein. Es gibt verschiedene Randomisierungsarten. Die randomisierte kontrollierte Studie ist der Goldstandard klinischer Interventionsstudien. Beim Lesen einer wissenschaftlichen Arbeit sollte kontrolliert werden, ob Forschungsdesign und -setting zur Forschungsfrage passen, und ob Fehlerquellen bedacht und kontrolliert wurden. Kritisch prüfen lassen sich auch Literaturangaben, Finanzierung und Expertise der Forschenden.
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  • 文章类型: Journal Article
    目的:已经开发了用于评估横断面研究的潜在偏倚风险(RoB)的不同工具,但目前尚不清楚是否解决了所有相关的偏见概念。我们旨在确定适用于横断面研究有效性的RoB概念,并探索现有评估工具中每个概念的覆盖范围。
    方法:这项范围审查遵循了乔安娜·布里格斯研究所的方法。我们包括任何描述或报告方法的研究设计记录,在健康研究中用于考虑RoB的概念或工具报告为描述性/患病率调查或分析/关联(横断面)研究设计。综合包括定量和定性分析。
    结果:在筛选的4,556条记录中,90人被选中纳入;67人(74%)描述了发展,或验证过程,评估工具,15(17%)描述了与RoB相关的方法学内容或理论,用于横断面研究,8(9%)记录了方法学系统综述。方法学报告的审查确定了用于描述性/患病率和分析/关联研究的重要RoB概念。确定的工具(n=64个独特的工具)旨在评估质量或评估多项研究设计中的RoB,包括横断面研究(n=21;33%)或仅横断面设计(n=43;67%)。对几种现有工具进行了修改(n=17;27%),以应用于横断面研究。RoB工具中最常见的RoB项目是暴露(53%)或结果(65%)测量的有效性和可靠性以及研究人群的代表性(59%)。大多数工具都没有适当地或根本没有考虑到无响应或错误。
    结论:评估横断面研究涉及独特的偏倚风险(RoB)考虑因素。我们确定了设计用于各种研究设计的广泛适用性的RoB工具,以及专门为横断面研究量身定制的工具。然而,已确定的工具均未全面解决与横断面研究相关的所有潜在偏见.我们的发现表明需要持续改进RoB工具,并建议开发针对此研究设计的特定环境或更精确的工具可能是必要的。
    OBJECTIVE: Different tools to assess the potential risk of bias (RoB) for cross-sectional studies have been developed, but it is unclear whether all pertinent bias concepts are addressed. We aimed to identify RoB concepts applicable to cross-sectional research validity and to explore coverage for each in existing appraisal tools.
    METHODS: This scoping review followed the Joanna Briggs Institute methodology. We included records of any study design describing or reporting methods, concepts or tools used to consider RoB in health research reported to be descriptive/prevalence survey or analytic/association (cross-sectional) study designs. Synthesis included quantitative and qualitative analysis.
    RESULTS: Of the 4556 records screened, 90 were selected for inclusion; 67 (74%) described the development of, or validation process for, appraisal tools, 15 (17%) described methodological content or theory relevant to RoB for cross-sectional studies and 8 (9%) records of methodological systematic reviews. Review of methodological reports identified important RoB concepts for both descriptive/prevalence and analytic/association studies. Tools identified (n = 64 unique tools) were either intended to appraise quality or assess RoB in multiple study designs including cross-sectional studies (n = 21; 33%) or cross-sectional designs alone (n = 43; 67%). Several existing tools were modified (n = 17; 27%) for application to cross-sectional studies. The RoB items most frequently addressed in the RoB tools were validity and reliability of the exposure (53%) or outcome (65%) measurement and representativeness of the study population (59%). Most tools did not consider nonresponse or missingness appropriately or at all.
    CONCLUSIONS: Assessing cross-sectional studies involve unique RoB considerations. We identified RoB tools designed for broad applicability across various study designs as well as those specifically tailored for cross-sectional studies. However, none of the identified tools comprehensively address all potential biases pertinent to cross-sectional studies. Our findings indicate a need for continued improvement of RoB tools and suggest that the development of context-specific or more precise tools for this study design may be necessary.
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  • 文章类型: Journal Article
    告知公共卫生政策制定者,当地循证知识的产生是关键。低收入和中等收入国家(LMIC)产生医学知识的研究能力通常很弱,资源不足,应对这些挑战的努力也没有标准化。持续的研究培训可以使研究人员具备所需的知识和研究技能,但是其有效性在很大程度上取决于所使用培训方法的质量和针对性。我们的目标是评估喀麦隆艾滋病毒/艾滋病研究论坛(CAM-HERO)2022研究方法和生物伦理学培训的有效性,目的是描述获得的知识以及卫生专业人员和临床科学家的自我效能。在为期一天的卫生专业人员和临床科学家培训期间进行了一项调查。参与者在与所教主题相关的培训前后进行了在线自我管理问卷。问卷由两部分组成:1)18个多项选择题(MCQs)评估知识;2)九个项目使用五点李克特量表评估自我效能感。计算平均分数,分析,并使用配对t检验比较前后检验结果。共有30名参与者(57%为女性)完成了社会人口统计学形式。参与者的中位年龄(IQR)为33.5(13.3)岁。我们在测试前登记了38名受访者,在测试后登记了33名受访者。知识平均得分从13.0上升到14.8(p=0.001),自我效能感的平均得分从2.9上升到3.7(p<0.001)。培训后,参与者对研究方法的知识和自我效能感得到了改善。这些结果表明,CAM-HERO2022培训对技能和自我效能感产生了直接的积极影响。因此,我们建议更大规模地实施这项培训,定期,并进行长期随访以评估其影响。
    To inform public health policymakers that the generation of local evidence-based knowledge is key. Research capacity in low- and middle-income countries (LMIC) to generate medical knowledge is often weak and insufficiently resourced and efforts to tackle these challenges are not standardized. Continuous research training can equip researchers with the required knowledge and research skills, but its effectiveness largely depends on the quality and pertinence of the training methods used. We aim to assess the effectiveness of the Cameroon HIV/AIDS Research Forum (CAM-HERO) 2022 Research Methodology and Bioethics Training with the objective to describe the knowledge gained and the self-efficacy of health professionals and clinical scientists. A survey was conducted during the one-day training among health professionals and clinical scientists. Participants took an online self-administered questionnaire before and after the training related to the topics taught. The questionnaire consisted of two parts: 1) 18 Multiple Choice Questions (MCQs) to assess knowledge and 2) Nine items to evaluate self-efficacy using a five-point Likert scale. Mean scores were calculated, analysed, and compared using paired t-test for the pre- and post-test results. A total of 30 participants (57% women) completed the socio-demographic form. The median age (IQR) of participants was 33.5 (13.3) years. We registered 38 respondents for the pre-test and 33 respondents for the post-test. There was a rise in knowledge mean score from 13.0 to 14.8 (p=0.001) and an improvement in the perception of self-efficacy with a mean score increase from 2.9 to 3.7 (p < 0.001). Knowledge and perception of self-efficacy on research methodology improved among participants after the training. These results suggest that the CAM-HERO 2022 training had an immediate positive impact on skills and self-efficacy. Hence, we recommend the implementation of this training on a larger scale, periodically, and with long-term follow-up to evaluate its impact.
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  • 文章类型: Journal Article
    背景:患者对药物的依从性可以使用交互式数字健康技术(如电子监护仪(EM))进行评估。必须表征治疗方案的变化和EM使用随时间的偏差,以建立药物依从性的实际水平。
    目的:我们开发了计算机脚本CleanADHdata。R清理原始EM依从性数据,本教程是用户指南。
    方法:除了原始EM数据之外,我们收集了依从性开始和停止监测日期,并确定了处方方案,根据规定的治疗方案,每天预期的EM开放次数,EM使用偏差,和患者人口统计数据。脚本对数据进行纵向格式化,并计算每天的用药执行情况。
    结果:我们提供了10名患者的模拟数据集,在中位187天(IQR135-342天)的时间内使用了15种EMs。EM原始数据清理前后患者实施的中位数为83.3%(IQR71.5%-93.9%)和97.3%(IQR95.8%-97.6%),分别(Δ+14%)。这种差异足以认为EM数据清理能够避免数据误解并在实现和持久性方面为依从性分析提供清理的数据集。
    结论:CleanADHdata。R脚本是一个半自动程序,增加了标准化和可重复性。该脚本在数字健康领域具有更广泛的适用性,因为它可用于清理使用各种数字技术收集的依从性数据。
    BACKGROUND: Patient adherence to medications can be assessed using interactive digital health technologies such as electronic monitors (EMs). Changes in treatment regimens and deviations from EM use over time must be characterized to establish the actual level of medication adherence.
    OBJECTIVE: We developed the computer script CleanADHdata.R to clean raw EM adherence data, and this tutorial is a guide for users.
    METHODS: In addition to raw EM data, we collected adherence start and stop monitoring dates and identified the prescribed regimens, the expected number of EM openings per day based on the prescribed regimen, EM use deviations, and patients\' demographic data. The script formats the data longitudinally and calculates each day\'s medication implementation.
    RESULTS: We provided a simulated data set for 10 patients, for which 15 EMs were used over a median period of 187 (IQR 135-342) days. The median patient implementation before and after EM raw data cleaning was 83.3% (IQR 71.5%-93.9%) and 97.3% (IQR 95.8%-97.6%), respectively (Δ+14%). This difference is substantial enough to consider EM data cleaning to be capable of avoiding data misinterpretation and providing a cleaned data set for the adherence analysis in terms of implementation and persistence.
    CONCLUSIONS: The CleanADHdata.R script is a semiautomated procedure that increases standardization and reproducibility. This script has broader applicability within the realm of digital health, as it can be used to clean adherence data collected with diverse digital technologies.
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  • 文章类型: Journal Article
    背景:在这个循证医学的时代,只有系统的研究才能帮助根据最新的知识和技能为个体患者提供明智和精确的医疗保健。然而,许多医疗专业人员没有足够的能力和信心来进行研究。原因之一可能是本科课程中缺乏基于研究的课程。国家医学委员会还强调需要对医疗保健专业人员进行研究方法的正式培训。研究方法研讨会有助于使参与者熟悉基本的,临床,和转化研究需要给予最佳的病人护理。我们研究的目的是通过评估参与者的知识来评估为研究生进行的研究方法研讨会,反馈,使用柯克帕特里克的评估模型和预期影响。
    方法:准实验,在132名一年级研究生中进行了单组研究。采用四个层次的柯克帕特里克模型进行评价。反馈表单,前测和后测的分数,研究生为论文起草的研究提案的质量,最终成功提交的研究提案是用于评估Kirkpatrick模型四个水平结果的组件。
    方法:收集的数据被编译并制成MSExcel。计算分类变量的比例以及分数的平均值和标准偏差(SD)。使用配对t检验对车间前和车间后分数之间的均值进行比较。P<0.05的值被认为是统计学上显著的。使用IBMSPSSStatistics版本20.0软件进行统计分析。
    结果:在132名参与者中,29%(38)为男性,71%(94)为女性。95%置信区间的平均±SD前测和后测分数分别为10.55±2.537和12.43±2.484。通过配对样本t检验发现差异具有统计学意义(P<0.001)。
    结论:参与者的反馈对于改进研究方法研讨会至关重要。讲习班满足了与会者的总体要求。研讨会结束后,参与者的知识有了显著提高。
    BACKGROUND: In this era of evidence-based medicine, only systematic research can help in providing judicious and precise healthcare to individual patients based on updated knowledge and skills. However, many medical professionals do not feel competent and confident enough to conduct research. One of the reasons could be the lack of a research-based curriculum in undergraduate courses. The National Medical Council has also stressed the need for formal training in research methodology for healthcare professionals. The research methodology workshops help to familiarize the participants with basic, clinical, and translational research required to impart optimum patient care. The objective of our study was to evaluate a research methodology workshop conducted for postgraduate students by assessing the participant\'s knowledge, feedback, and expected impact using Kirkpatrick\'s evaluation model.
    METHODS: A quasi-experimental, single-group study was conducted among 132 first-year postgraduate students. The four levels of Kirkpatrick\'s model were applied for evaluation. Feedback forms, scores of the pretest and posttest, quality of the research proposal drafted by the postgraduates for their thesis, and finally successful submission of the research proposal were the components used to evaluate the four levels of outcome of Kirkpatrick\'s model.
    METHODS: Data collected were compiled and tabulated into MS Excel. Proportions were calculated for categorical variables and mean and standard deviation (SD) for scores. A comparison of means between pre- and postworkshop scores was made with paired t-test. A value of P < 0.05 was considered statistically significant. Statistical analysis was done using IBM SPSS Statistics version 20.0 software.
    RESULTS: Out of 132 participants, 29% (38) were males and 71% (94) were females. The mean ± SD pretest and posttest scores at a 95% confidence interval were 10.55 ± 2.537 and 12.43 ± 2.484, respectively. The difference was found to be statistically significant by paired sample t-test (P < 0.001).
    CONCLUSIONS: Participant feedback is vital for improving research methodology workshops. The workshop met the overall requirements of the participants. There was a significant improvement in the knowledge of participants after the workshop completion.
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  • 文章类型: Journal Article
    背景:实施科学有助于生成方法,以加快在实践中的证据吸收。混合方法通常用于实施研究,因为它们允许研究人员集成不同的定性和定量方法以及数据集来解开实施过程和上下文,并设计上下文工具以优化实施。迄今为止,关于如何确保混合方法实施研究的严谨性的讨论有限。
    目的:为了呈现特殊性,订婚,可操作的推论,自反性,和合法性(PEARL)作为一种实用工具,用于理解混合方法实施研究中严格性的各个组成部分。
    方法:本方法讨论基于护士主导的混合方法实施研究。PEARL工具是基于解释性的,批判性反思,并有目的地阅读从研究人员的知识中提取的选定文献来源,设计和实施混合方法实施研究的经验,并发表了关于混合方法的方法学论文,实施科学,和研究严谨。
    结论:提供了一项示例性的探索性序贯混合方法在护理中的应用,以说明PEARL工具的应用。对于打算在实施研究中使用混合方法的研究人员和学生来说,所提出的工具可以成为有用的创新工具。该工具提供了一种简单的方法来学习混合方法实施研究的关键严格组成部分,以便在使用混合方法进行设计和实施研究时应用。
    结论:严格的实施研究对于将创新和循证知识有效地纳入实践和决策至关重要。拟议的工具可以用作在护理和健康科学的混合方法实施研究中建立严格性的手段。
    BACKGROUND: Implementation science helps generate approaches to expedite the uptake of evidence in practice. Mixed methods are commonly used in implementation research because they allow researchers to integrate distinct qualitative and quantitative methods and data sets to unravel the implementation process and context and design contextual tools for optimizing the implementation. To date, there has been limited discussion on how to ensure rigor in mixed methods implementation research.
    OBJECTIVE: To present Particularity, Engagement, Actionable Inferences, Reflexivity, and Legitimation (PEARL) as a practical tool for understanding various components of rigor in mixed methods implementation research.
    METHODS: This methodological discussion is based on a nurse-led mixed methods implementation study. The PEARL tool was developed based on an interpretive, critical reflection, and purposive reading of selected literature sources drawn from the researchers\' knowledge, experiences of designing and conducting mixed methods implementation research, and published methodological papers about mixed methods, implementation science, and research rigor.
    CONCLUSIONS: An exemplar exploratory sequential mixed methods study in nursing is provided to illustrate the application of the PEARL tool. The proposed tool can be a useful and innovative tool for researchers and students intending to use mixed methods in implementation research. The tool offers a straightforward approach to learning the key rigor components of mixed methods implementation research for application in designing and conducting implementation research using mixed methods.
    CONCLUSIONS: Rigorous implementation research is critical for effective uptake of innovations and evidence-based knowledge into practice and policymaking. The proposed tool can be used as the means to establish rigor in mixed methods implementation research in nursing and health sciences.
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