The Challenges of Conducting a Nurse-Led Intervention in a Randomized Controlled Trial with Vulnerable Participants

Park, Tanya; Usher, Kim; Foster, Kim

doi:10.1155/2014/394237

Cited by 4 publications

(10 citation statements)

References 21 publications

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“…Literatür incelendiğinde, bu çalışmanın bulgularından farklı olarak, literatür tarama aşaması diğer araştırmacılar tarafından bir güçlük olarak belirtilmemiştir. (7,11,14,18,20) Bu farklılığın ülkemizdeki mevcut eğitim sistemi, araştırma tasarımlarına yönelik verilen derslerin içeriğinin yetersiz olması, hemşirelik alanında yapılan randomize kontrollü araştırmaların sınırlı…”

Section: Discussionunclassified

“…Yapılan literatür taramasında, hemşirelik alanında yürütülen randomize kontrollü araştırma deneyimlerine sınırlı olarak yer verildiği görülmektedir. (7,14,(17)(18)(19)(20) Diğer taraftan, hemşirelik alanında çalışan akademisyenlerin randomize kontrollü araştırmalara ilişkin yaşadıkları bireysel deneyimlerini derinlemesine inceleyen herhangi bir araştırmaya rastlanmamıştır. Bu nedenle, hemşire akademisyenlerin perspektifinden alanda yürütülen randomize kontrollü araştırmalara yönelik olumlu ve/veya olumsuz deneyimlerin ortaya konması ile diğer araştırmacılara önemli katkılar verilebileceği, araştırma sürecinde karşılaşılabilen güçlüklerin nedenlerinin açıklanabileceği ve bu güçlüklere ilişkin çözüm önerilerinin verilebileceği öngörülmüştür.…”

Section: • Researchunclassified

“…Hemşire Akademisyenlerin Perspektifinden Randomize Kontrollü Araştırmalara İlişkin Deneyimler: Nitel Bir Çalışma olması ve bu konudaki deneyim yetersizliğinden kaynaklanabileceği öngörülmüş, randomize kontrollü araştırmaların değerlendirildiği ulusal ve uluslararası literatürde sınırlı sayıda çalışma olmasının da diğer bir etken olabileceği düşünülmüştür. (7,(18)(19)(20) Bu çalışmada, akademisyenler, etik kurul ve/veya kurum izinlerinde güçlükler yaşadıklarını bildirmişlerdir. Bu durum, Vedelø ve Lomborg (7) tarafından kaleme alınan bir sistematik derlemede de belirtilmiş, ilgili derlemeye dâhil edilen ve hemşireler tarafından yürütülen toplam sekiz randomize kontrollü araştırmanın dördünde hemşireler kurumsal engellerle karşılaştıklarını rapor etmişlerdir.…”

Section: • Researchunclassified

“…(19) Park ve ark. (20) yürüttükleri randomize kontrollü bir araştırmada, bu çalışmaya benzer şekilde katılımcıların randomizasyona dirençli olduğundan, randomizasyon kuralları açıklanmasına rağmen, katılımcıların kendi dâhil oldukları grubun dışındaki müdahaleye katıldıklarını ve bunu engelleyemediklerini belirtmişlerdir. Hemşirelerin yürüttükleri randomize kontrollü araştırmalarda yaşanan güçlükleri rapor eden sistematik bir derlemede de benzer sorunlar bildirilmiş, potansiyel katılımcıların araştırmaya dâhil edilmesi, zaman ve maliyet yönetiminde yetersiz kalındığı vurgulanmıştır.…”

Section: • Researchunclassified

“…Literatür incelendiğinde, çözüm önerilerine ilişkin sınırlı sayıda yayına rastlanmıştır. (7,(18)(19)(20) Bu çalışmanın bulgularına benzer olarak, literatürde de potansiyel katılımcıların araştırmaya katılımını arttırmaya yönelik kurumlarla etkin iletişim ve iş birliğinin sürdürülmesi önerilmiştir. (7,18) • research…”

Section: • Researchunclassified

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Experiences about Randomized Controlled Trials from the Perspective of Nurse Academicians: A Qualitative Study

İzgü¹,

Metin²

2020

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Aim: This study aimed to thoroughly investigate nurse academicians' experiences about randomized controlled trials. Methods: This descriptive qualitative study was conducted between March and April 2019 with seven nurse academicians working in a public university having experience in randomized controlled trials. Data were collected in face-to-face, in-depth interviews using a semistructured interview guide. Interviews were recorded via a voicerecorder and transcribed verbatim. Data were interpreted by the themes and subthemes that emerged with descriptive analysis. Results: Themes and (subthemes) emerging from qualitative analysis included (1) challenges faced during randomized controlled trials (literature reviews, ethical and/or institutional approvals, administration and publication processes of the research, (2) achievements from conducting randomized controlled trials (individual and academic), and (3) problem-solving strategies related to the challenges experienced during randomized controlled trials (having comprehensive knowledge of research issue and literature, improving communication skills, being determined to conduct research, and focusing on the contributions of the research rather than worrying about publication). Conclusion: This study revealed that nurse academicians face important challenges related to study design, data collection, data analysis, and reporting of randomized controlled trials' outcomes. Another important finding is that despite the challenges, academicians reported they were satisfied with the process and offered solutions to the challenges. Based on these results, it is recommended that nurse academicians attend comprehensive lectures and/or courses related to randomized controlled trials.

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Section: Discussionunclassified

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Experiences about Randomized Controlled Trials from the Perspective of Nurse Academicians: A Qualitative Study

İzgü¹,

Metin²

2020

HEAD

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A Reflection on the Tensions of Acting in Dual Roles of Doctoral Researcher and Practitioner when Evaluating a Lifestyle Intervention for Breast Cancer Patients

2022

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This reflection was completed as part of a doctoral project to develop and trial a lifestyle intervention for people following the completion of their treatment for breast cancer. In this study the graduate student acted in the dual roles of nutrition practitioner and researcher. This article uses the experience, reflection, action (ERA) cycle of reflection to consider some of the tensions faced due to the divergent priorities and requirements of these two roles. One challenge occurred during study recruitment when a few potential participants did not meet the inclusion criteria for the study but still wished to attend the intervention sessions. It was also a challenge to mitigate the risks of distress of potentially vulnerable participants during group intervention sessions. In both instances there was a potential conflict between the needs of patients and research requirements. This reflection concluded that the obligations of both roles should be adhered to where possible, but if in doubt, the needs of the participants were paramount.

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Ensuring Intervention Fidelity of an Attention Control Arm in a Multisite Randomized Controlled Trial

Newman,

Moody,

Becktell

et al. 2023

Nursing Research

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Background Intervention fidelity is a critical element of randomized controlled trials, yet reporting of intervention fidelity among attention control arms is limited. Lack of fidelity to attention control procedures can affect study outcomes by either over- or underestimating the efficacy of the intervention under examination. Objectives This brief report describes the approach researchers took to promote fidelity to the attention control arm of a National Institutes of Health-funded pediatric palliative care randomized controlled trial. Methods The Informational Meetings for Planning and Coordinating Treatment trial aims to determine the efficacy of a communication intervention that uses care team dyads (i.e., physicians partnered with nurses or advanced practice providers) to engage parents of children with cancer that have a poor prognosis in structured conversations about prognostic information, goals of care, and care planning. The intervention is compared to an attention control arm, which provides parents with structured conversations on common pediatric cancer education topics, such as talking with their child about their cancer, clinical trials, cancer treatment, side effects, etc. National Institutes of Health guidelines for assessing and implementing strategies to promote intervention fidelity were used to design (a) the attention control arm of a randomized controlled trial, (b) related attention control arm training, and (c) quality assurance monitoring. Results Attention control study procedures were designed to mirror that of the intervention arm (i.e., same number, frequency, and time spent in study visits). Cluster randomization was used to allocate care team dyads to one arm of the randomized controlled trial. Care team dyads assigned to the attention control arm participated in online training sessions to learn attention control procedures, the different roles of research team members, and quality assurance methods. Fidelity to attention control procedures is assessed by both the interveners themselves and a quality assurance team. Discussion Study design, training, and delivery are all critical to attention control fidelity. Baseline training often needs to be supplemented with booster training when time gaps occur between study start-up and implementation. Quality assurance procedures are essential to determine whether interveners consistently deliver attention control procedures correctly.

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The Challenges of Conducting a Nurse-Led Intervention in a Randomized Controlled Trial with Vulnerable Participants

Cited by 4 publications

References 21 publications

Experiences about Randomized Controlled Trials from the Perspective of Nurse Academicians: A Qualitative Study

Experiences about Randomized Controlled Trials from the Perspective of Nurse Academicians: A Qualitative Study

A Reflection on the Tensions of Acting in Dual Roles of Doctoral Researcher and Practitioner when Evaluating a Lifestyle Intervention for Breast Cancer Patients

Ensuring Intervention Fidelity of an Attention Control Arm in a Multisite Randomized Controlled Trial

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