Our study aimed 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. The results showed that the controls were divided as to whether the assessment interviews had facilitated their adjustment process. Several participants expressed that the assessment interviews had influenced their reflections about their condition with the potential to facilitate their adjustment process. The assessment interviews might also encourage some participants to seek professional support. Other participants, however, stated that the assessment interviews did not influence their reflections about their condition or their adjustment process.
Ideally, in behavior experiments conducted in stringent and tightly controlled conditions, experimental manipulation would be the only difference between groups formed by random allocation (26). In complex intervention studies, however, performed in participants’ natural environment, the design of the control conditions will be less stringent. In the current study, the basis of the RCT design was that responding to the test battery would have no influence on participants’ adjustment process. The test procedure implied that the data collectors were instructed to adhere primarily to the questionnaire. But they were not instructed not to respond to any questions from the participants. Participants’ unmet needs for information and support were demonstrated in this study. In addition, the questions in the test battery might have been perceived as an invitation to reflect about their condition and existential issues. Such factors could blur the difference between the intervention group and the control group. In that sense, the assessment test procedure might threaten the internal validity of the RCT (4), and possibly influence the results.
One striking result of this study was that dialogues of 30–45 minutes with a dedicated professional on three occasions seemed to facilitate these participants’ reflections on their condition. Our results suggest that the mere attention, listening and dialogue with a professional might have had an impact on the adjustment process of the controls. However, considering the premises for an experimental trial, no influence on the controls, it is necessary to assess how to counteract such tendencies to influence participants’ adjustment process. It is therefore essential to clarify the underlying factors contributing to influence or lack of influence. These underlying factors might be related to characteristics of the participants or of the data collectors, or to contextual factors, as will be discussed in the following.
The participants
Participants’ descriptions of their illness experiences and of their adjustment process varied considerably. Most participants had minor to moderate impairments, and one had a moderate to severe stroke, based on the National Institutes of Health Stroke Scale (NIHSS) score of stroke severity (27) (Table 1). For five participants the NIHSS score was unknown. Thus, we cannot conclude that the influence of the assessment interviews corresponded with the degree of stroke severity. The results illustrated participants’ drive and struggle to recover and regain their perception of their pre-stroke self, independently of their statements of “influence” or “no influence”. In this way, participants’ desire and efforts to gain support, information and understanding might be an expression of positive adaptation in terms of their sense of coherence (SOC) (28), or their level of resilience (16, 29). In cases when participants described their experiences of inadequate follow-up and shortcomings in hospital and community health care, they also emphasized the influence of the assessment interviews. Thus, participants’ needs for support might be related to their personal ability to cope and adjust, to the quality of their family network, and to possible gaps in the quality of health care services.
Some participants might have confused the role of the data collector with the roles of primary health professionals. Our results illustrate that some participants had expectations for the trial that extended beyond the limitations of their roles as control group participants. Considering that some participants’ interpreted the assessment interviews as “dialogues” or “discussions”, the boundaries between a mere data collector and a health care professional seemed to be blurred. These expectations indicated that they were somewhat confused as to how the study related to the ordinary health care services. These findings are consistent with other studies indicating that trial participants struggle to understand the difference between trials and treatment, despite provision of clear and accurate information (30–35).
These results illustrate a general ethical research challenge, namely participants’ difficulties in understanding the nature of clinical trials, including the distinction between treatment in general and research participation. The term “therapeutic misconception” means that a research participant does not fully understand that the primary purpose of a trial is to produce knowledge for the benefit of future patients, as distinct from helping the patient with her current condition (30, 36–39). These misconceptions might result in unrealistic expectations, and thus disappointment at the lack of help offered during the encounters with the data collectors. Such misconceptions also reflect poor general knowledge in the population about RCTs, and what participation involves (6). This calls for a greater focus on educating the public about clinical trials, to improve knowledge of the reasons for participating in RCTs, and what participation entails (6). It also underlines the primary responsibility of researchers to clarify this, both when informing about trials and through data collection.
It is important to consider the fact that several of the questions in the test battery invited the participants to reflect on existential issues. Some participants expressed concern that assessment questions about mental problems and suicidal thoughts could cause harm in terms of triggering dangerous thoughts in other participants. Thus, it might be challenging, yet unavoidable, to balance the research ethical principle of doing no harm with the necessity to pose sensitive questions based on the validated instruments.
The data collectors
Nonspecific factors such as “human interaction variables”, clinicians’ warmth and empathy may have a substantial impact on the outcome of an RCT, as previously shown (4). It might be challenging to balance the participants’ needs for information and support with the methodological and research ethical guidelines guiding RCTs, i.e. avoiding influencing the participants’ reflections about their condition and their adjustment process. However, in order to avoid bias, it seems important to train and supervise data collectors to balance these seemingly contradictory demands. It should be noted that this might be particularly demanding when collecting face-to-face data from participants who might have cognitive impairment. 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).
Is there any solution to these inevitable and seemingly conflicting obligations? Is it possible to counteract and minimize these tendencies to influence control group participants when conducting assessment interviews? Some authors propose that disclosure of information about the trial should be restricted, and that the participants should be given neutral information (36). If the controls had been unaware of the existence of the study arm, this might have diminished the risk of study-induced behavior change (3). However, there is a fundamental principle and broad agreement among research ethicists that the duty to obtain informed consent follows from the principle of respect for research participants (41, 42). Thus, to withhold such vital information would be considered unacceptable from a research ethical point of view (3). However, it is argued that in pragmatic trials with high social value, and with low risk or no risk, a waiver of informed consent should be considered ethically acceptable (43). Another argument is that a waiver of consent might be acceptable in intervention studies, in cases where bias is likely to occur (44).
The Zelen design involving obtaining consent from participants after randomization has been suggested to minimize these kind of threats in RCTs (45). Only those who had been randomized to the experimental group would then be asked to consent to participation in the trial, while the controls would remain uninformed (44–46). In a modified two-stage consent design, those assigned to the control group would receive the usual care, and they would know that other people received different care, but without knowing what that care entailed (47).
Applying the Zelen design adjusted to our study, the control group participants would neither be informed nor aware of the existence of the intervention. But they would be informed about, and could then consent to participate in, the assessment interviews at the prescribed three points in time, T1, T2 and T3. This approach might be perceived as meaningful by the controls, both as a potential confirmation of their own progression and adjustment, and as an opportunity to contribute to research for the benefit of other stroke survivors. Simultaneously, one would avoid the experiences of disappointment of not being allocated to the intervention group. This might be considered as an ethically sound approach, especially taking into account that this trial does not imply any risk for the participants, neither for those in the intervention group nor for the controls. However, out of respect for research participants’ autonomy, obtaining informed consent has been considered as a cornerstone in research ethics (42, 48). At the same time, taking into account research participants’ vulnerability, the importance of building and maintaining long-term trusting relationships between researchers and participants has been highlighted (49). Thus, it may still be debatable whether, or in which circumstances, a waiver of consent can be ethically justified.
We cannot disregard the possibility that the number of data collectors involved, their diverse professional backgrounds, and possible variation in conduct in the interviews might have resulted in different approaches during the sessions. This might raise questions about possible alternative, or more uniform, approaches in order to achieve no influence. However, for practical reasons, and to obtain valid data from stroke survivors with different stroke-related impairments, we considered a certain number of experienced and trained health professionals as necessary to conduct the assessment interviews.
Contextual factors
We decided to implement the assessment interviews of the RCT in the participants’ natural environment, primarily in their private homes. Face-to-face assessment interviews were considered a necessity, as the sample of stroke survivors eligible for trial participation was considered a vulnerable group that might have difficulty in answering the questions without sufficient guidance. When designing this trial, the population of stroke survivors from where we recruited our participants were expected to be elderly, with severe impairments, such as paresis, fatigue and cognitive and language impairment. Thus, we anticipated a low response rate if we collected the data by mail or phone. However, both the assessment interviews themselves and the setting of the participants’ homes had the potential to draw the participants’ attention to their condition, and also to influence their help-seeking behavior.
The one and only influence on the controls was meant to be the delivery of standard stroke treatment in terms of primary rehabilitation services.
To protect the control group participants from the influence of face-to-face assessment interviews, either telephone interviews or answering the questionnaires on their own would have been alternatives. However, one should consider the obvious challenges associated with assessments from stroke survivors with varying degrees of impairment. In that case, the planning and implementation of the assessment interviews should have been subject to meticulous attention and preparation.
Methodological considerations
Our sampling procedure was selected to include participants with various socio-demographic and stroke-related characteristics. Participants’ disclosure of their experiences of illness and of participating in the RCT revealed rich and nuanced data. However, in view of the small sample size, we cannot conclude that the results were representative of all the controls in this RCT. Considering some of the participants’ stroke-related impairments, memory loss might have influenced their perception and judgment of the influence of the assessments. It is still not clear whether or how far the assessments actually had any influence. The interviews were performed in retrospect after the completion of the T3 assessment interviews. The participants might have had difficulty in recalling the assessment interviews and the encounters with the data collectors, which could have influenced the results.
All the researchers were involved in the development of the interview guide and in the analysis process. Nine researchers conducted the qualitative interviews. Six of them had participated as intervention providers, but did not interview any of the participants they had visited and followed up in that capacity. Several other interviewers had participated in the development of the trial, and had worked as project coordinators. Some interviewers had acted as data collectors, although they had not previously collected any data from these participants. Some of the interviewers’ extensive knowledge of and involvement in the trial might have strengthened the depth and nuances of the interviews. On the other hand, it is possible that such insight and involvement might represent a disadvantage in terms of not maintaining a sufficiently distant and objective view during the interview sessions and in the analysis. However, having a number of researchers with different levels of involvement in the RCT probably counteracted this potential weakness.