Comment on: Broekema S. et al (2021) Effects of family nursing conversations on families in home health care: A controlled [...] study. JAN, 77, 231-243

The effect of two-family nursing conversations on caregiver burden, family function and patients quality of life was tested in a clinical trial by Broekema et al. (2021) and reported—in part—in the Journal of Advanced Nursing (there are three other papers from this study published elsewhere Broekema et al., 2018, 2020; Broekema, Paans, Oosterhoff, et al., 2021). Participants, who were in their 80s and receiving long-term home care because of chronic illness or fragility (a quarter had dementia) were allocated to receive a ‘family nursing conversation’ or usual care. One hundred and eleven patients were enrolled in the trial and provided written informed consent. The authors concluded that family nursing conversations were effective at preventing family caregiver burden, improving family function but did not enhance patients' quality of life. According to the manuscript ‘impact statement’ family nursing conversations are a valuable addition to home health care. According to SCOPUS the study has been cited three times (date of checking 4 August 2023). We write like to draw attention to fact that the Broekema et al. (2021) trial was not reviewed by a human research ethics committee, yet seemingly involved vulnerable participants. In drafting this letter we reviewed the peer review history of the paper (accessed via Clarivate, web of science) as well as the published manuscript (Broekema, Paans, Roodbol, et al., 2021). The authors appear to be reporting the results of a clinical trial which, according to the declaration of Helsinki, requires that the research is reviewed by an ethics committee prior to the research starting (WMA, n.d..). Are Broekema et al. (2021) reporting a clinical trial? The World Health Organization (Clinical trials, n.d.) define a clinical trial as ‘any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes’. Broekema et al. (2021) clearly state that what is being reported in the paper is research, and not a service evaluation or clinical audit. It is also clear that the researchers prospectively assigned human participants (families) to an experimental (family nursing conversations) or control (home health care as usual) intervention (Broekema et al., 2021, p. 235). Finally, outcomes of interest were health related (for example, patients' health related quality of life, determined using the EQ-5D that consists of five dimension mobility, self-care, usual activities, pain/discomfort and anxiety depression (Balestroni & Bertolotti, 2012; Broekema et al., 2021, pp. 235–236). Seemingly, from the peer-review records, the journal editor agreed that what is being reported is a clinical trial when writing to the authors in correspondence (dated 13/6/2020) ‘…please do the trail [trial] registration retrospectively…’ It is of paramount importance that clinical trials are reviewed by a Human Research Ethics Committee because although a clinical trial is a test of an experimental intervention that may be beneficial it may also be associated with unexcepted harms (World Health Organization, 2005, p. 1). By participating in a trial people are placing themselves at risk often because they consider the research will benefit others. However, on the paper Broekema et al. (2021) state ‘…the regional medical ethical committee ruled that this study does not fall under the Dutch Medical Research Involving Human Subjects Act and, therefore, waived approval…’ (Broekema et al., 2021, p. 235). In the Netherlands research involving human subjects is called the WMO (EUREC—Legislation—The Netherlands, n.d.). There are two possible reasons why WMO approval was waived for this trial. First, according to their website research requires WMO approval if participants are subject to procedures or are required to follow rules of behaviour AND it concerns medical scientific research (Ministerie van Volksgezondheid, 2018). The WMO does seem ambiguous as to whether nursing research is considered medical scientific research stating that ‘…nursing, physiotherapy and psychology research can in some cases be subject to the WMO…’ (Ministerie van Volksgezondheid, 2018). It may be that this was the advice that was given to the trial authors and why the need for approval was waved. The second reason that ethical approval may have been waived is because the WMO, seemingly, does not require that all clinical trials receive WHO approval. This does seem contrary to the declaration of Helsinki (The World Medical Association [WMA], n.d.). However, on their website WMO only refers to randomized trials requiring ethical approval and only in certain circumstances (Ministerie van Volksgezondheid, 2018). It maybe that because Broekema et al. (2021) are not reporting a randomized trial then WMO approval was not required. Further, the type of intervention being tested also determines if ethical approval is required, WMO stating ‘…the degree to which the rules of conduct or the abstinence from treatment(s), interventions or procedures may cause an infringement of the physical and/or psychological integrity of the subject determines whether the study is subject to the WMO…’ (Ministerie van Volksgezondheid, 2018). It may be that Broekema et al. (2021) argued that the two family nursing conversations, the intervention in this trial, did not cross this threshold. Another potential ethical concern is that the Broekema et al. (2020) trial involved vulnerable participants. According to the Declaration of Helsinki (WMA, n.d.), vulnerable participants are characterized as people that ‘may have an increased likelihood of being wronged or of incurring additional harm’ and have a reduced ability to provide informed consent (WMA, n.d.). The WMO considers that there are four groups—incapacitated people, minors, pregnant and breastfeeding women and trials in an emergency situations—that have specific requirements because of vulnerability (Ministerie van Volksgezondheid, 2021). In the Broekema et al. (2021) trial 25% of patients and 36% of family members had dementia that would likely mean they were vulnerable (incapacitated people) and may not have had capacity to provide informed consent. In the manuscript Broekema et al. (2021, p. 235) state only that ‘all participants signed an informed consent form before entering the study and were informed that they could retract their permission at any time’. It does not seem as though there was any consideration of the vulnerability of participants. Does the fact that WMO waived the need for ethical approval in the Broekema et al. (2021) trial obviate researchers of the need to consider the additional protections that are required when involving vulnerable people in research? According to Gordon (2020), when involving vulnerable people in a study, researchers should consider first, if inclusion is necessary and if it is, then, second, what additional protections might be necessary. Reviewing the paper there is no evidence as to whether the required additional considerations—was information presented in an understandable way, did potential participants able to understand what was required of them participating and did they comprehend their rights as research participants—for informed consent were satisfied. Broekema, Paans, Roodbol, et al. (2021) are clearly reporting the results of a clinical trial a of a novel intervention despite describing the study as a controlled before and after study. Clinical trials should be reviewed by an ethics committee. Given that the research involved vulnerable people, there should have been—in the published manuscript—a considered and detailed justification as to why it was necessary to include them in the research and what additional safeguards were in place. In our view it would be informative to readers of the Journal of Advanced Nursing if the trial authors could discuss the complex ethical issues that this work raises.