When Nursing Care and Clinical Trials Coincide: A Qualitative Study of the Views of Nordic Oncology and Hematology Nurses on Ethical Work Challenges

Godskesen, Tove; Petri, Suzanne; Eriksson, Stefan; Halkoaho, Arja; Mangset, Margrete; Pirinen, Merja; Nielsen, Zandra Engelbak

doi:10.1177/1556264618783555

Cited by 17 publications

(30 citation statements)

References 28 publications

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“…While role conflicts can occur at any time during a study, they appear strongly during the informed consent process (Cantini & Ells, ; Cresswell & Gilmour, ; Godskesen et al, ; Hill & MacArthur, ; Höglund et al, ). Research nurses’ role conflicts and ethical dilemmas within the informed consent process include being asked to approach patients about a study at an inappropriate time, patients not reading the consent form due to their trust of healthcare professionals and patients not being fully informed of what is required in the study (Cantini & Ells, ).…”

Section: Discussionmentioning

confidence: 99%

Clinical research nurses’ expectations and realities of their role: A qualitative evidence synthesis

Hernon

Dalton

Dowling

2019

Journal of Clinical Nursing

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Aims To synthesise the available body of qualitative studies relating to clinical research nurses’ experiences of their role. Methods A systematic search of the literature in five databases was undertaken: CINAHL, MEDLINE, EMBASE, PubMed and ProQuest. Thomas and Harden's three‐stage approach to thematic analysis was followed using the ENTREQ statement for reporting. Results Nineteen studies reported in 20 papers (with a total of 232 nurses) were included in the synthesis. Three analytical themes with six subthemes were identified as follows: “identity”; “meeting targets”; and “patient advocate.” Conclusions Clinical research nurses experience isolation, and contributing to this is their perception of nonresearch nurses’ lack of understanding for their role. This can result in difficulties when recruiting study participants. Clinical research nurses can experience internal conflict between being a patient advocate and adhering to a trial protocol. Relevance to clinical practice Training is needed to help research nurses develop skills to face challenges in order to ensure safe and ethical care is provided to research participants while also ensuring high‐quality data collected for the study.

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Section: Discussionmentioning

confidence: 99%

Clinical research nurses’ expectations and realities of their role: A qualitative evidence synthesis

Hernon

Dalton

Dowling

2019

Journal of Clinical Nursing

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“…Considering stroke survivors' medical condition and vulnerability, it might be challenging to take a neutral or distant attitude towards the participant. However, data collectors are confronted with the demand to balance the ethical challenges that might arise when opposing ethical obligations to care and research overlap (40).…”

Section: The Data Collectorsmentioning

confidence: 99%

Control Group Design in a Complex Intervention Study: Challenges, Dilemmas and Possible Solutions

Mangset¹,

Kitzmüller²,

Evju³

et al. 2020

Preprint

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Background The use of a control group is one of the most critical components of an RCT. The control conditions may change over time and include assessment interviews and standard stroke treatment. Therefore, the control group should be monitored and described in as much detail as the intervention group. It is important to find ways to reduce the risk of study-induced influence on the members of the control group. The aim of this study was to explore the possible influence of the assessment interviews on the adjustment of the members of a control group in an RCT exploring psychosocial well-being following stroke. Methods Fifteen participants in the control group of the RCT, six women and nine men, aged 29-88 years, were interviewed in narrative semi-structured interviews. Ricoeur’s interpretation theory guided the analysis. Results The perceived influence of the assessment interviews on the control group varied considerably. Two different themes with subthemes were identified, describing the influence of the assessment interviews in the control group. Theme one described how participants emphasized the perceived influence of the assessment interviews that served as a safety net, enhanced their awareness and understanding, facilitated their adjustment after stroke, encouraged them to seek support, and allowed them to vent their disappointment of having been allocated to the control group. Theme two described participants’ experiences of handling their adjustment process on their own without describing any influence of the assessment interviews on their condition. These participants highlighted mild strokes, spontaneous recovery, setting own goals, support from family and friends and supporting research. Conclusions In view of the design challenges in RCTs, it seems important to explore in depth how to design assessment interviews with control group members without introducing risk of bias, and to uphold rigor and stringency in the trials.

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“…Part I is empirical and consists of semi-structured interviews, while Part II comprises a literature review to provide a comprehensive summary of current evidence relevant to the question of whether clinical trials are superior to standard care. The empirical data were collected as part of a larger project (briefly summarised below) that is described in detail elsewhere, including recruitment and data collection [15,16]. We followed the Standards for Reporting Qualitative Research (SRQR) in methods, results and discussion to improve the quality and transparency [26].…”

Section: Designmentioning

confidence: 99%

“…Peppercorn et al [14] cited several typical examples of oncologists who believe that patients in trials have better outcomes than those not in a trial. In previous studies we found that this is an important issue for physicians and nurses who experience ethical challenges when clinical care and research are intertwined [15,16]. Physicians and nurses found that a most difficult challenge was end-of-life patients eager to participate in all kinds of cutting-edge drug trials, often with an unrealistic hope for possible gain.…”

Section: Introductionmentioning

confidence: 99%

“…Nurses were often concerned about patients' level of unrealistic hope and about their well-being sometimes becoming secondary to research participation. They sometimes wondered if palliative care would be more beneficial than participating in research [15]. In other words, belief in trial superiority might have costs, but if the belief is warranted, then disregarding it would have even worse consequences.…”

Section: Introductionmentioning

confidence: 99%

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Are cancer patients better off if they participate in clinical trials? A mixed methods study

et al. 2020

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Background: Research and cancer care are closely intertwined; however, it is not clear whether physicians and nurses believe that clinical trials offer the best treatment for patients and, if so, whether this belief is justified. The aim of this study was therefore: (i) to explore how physicians and nurses perceive the benefits of clinical trial participation compared with standard care and (ii) whether it is justified to claim that clinical trial participation improves outcomes for cancer patients. Methods: A mixed methods approach was used employing semi-structured interviews with 57 physicians and nurses in oncology and haematology and a literature review of the evidence for trial superiority, i.e. the idea that receiving treatment in a clinical trial leads to a better outcome compared with standard care. Inductive thematic analysis was used to examine the interview data. A literature review comprising nine articles was conducted according to a conceptual framework developed by Peppercorn et al. and evaluated recent evidence on trial superiority. Results: Our findings show that many physicians and nurses make claims supporting trial superiority, however very little evidence is available in the literature comparing outcomes for trial participants and non-participants that supports their assertions.

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When Nursing Care and Clinical Trials Coincide: A Qualitative Study of the Views of Nordic Oncology and Hematology Nurses on Ethical Work Challenges

Cited by 17 publications

References 28 publications

Clinical research nurses’ expectations and realities of their role: A qualitative evidence synthesis

Clinical research nurses’ expectations and realities of their role: A qualitative evidence synthesis

Control Group Design in a Complex Intervention Study: Challenges, Dilemmas and Possible Solutions

Are cancer patients better off if they participate in clinical trials? A mixed methods study

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