for HIV/AIDS clinical trial participants: a focus group study of patients, clinician .. Reflecting a valued patient-doctor relationship, the main scenario where. Keywords: clinical research; HIPAA; recruitment barriers; participant recruitment depends on establishing a strong working relationship between the research. While research engagement refers to clinicians participating in and leading and the relationship between factors facilitating and supporting clinician research .
Search strategies are available in Additional file 1. Database searching was supplemented by reference list checking and further Google Scholar scoping searches because the difficulties balancing search specificity and sensitivity meant that eligible papers might be missed.
English language due to the barrier of translation costs ; health research in patient settings; primary studies and first-person accounts detailing examples of how dual-role was experienced by clinician-researchers. We define clinician as a member of a registered health profession involved in direct patient care e. We excluded scholarly papers without first-person data about clinician-researcher experiences of dual-role; papers where researchers were not clinicians or it was not clear ; research including clinician-researchers and non-clinician-researchers where the experiences of the two groups could not be differentiated; and health-related research in non-patient settings e.
Search results were imported into Endnote, and after de-duplication all records were screened for eligibility by one researcher MB. Disagreements about eligibility were resolved through discussion and decision rules recorded to support subsequent judgements. Reports were loaded into NVivo and all instances of dual-role experience coded. The coding focus was to ask what was happening researcher or participant behaviour, researcher feelings or thoughts when dual-role was experienced by the clinician-researcher.
Specifically, the analytic stages were: Initial codes were generated and discussed by the two researchers MB, JHS using deductive and inductive techniques; 2 data in each coding category were examined and higher level codes developed and data re-coded if necessary through discussion in four regularly spaced meetings of all researchers; 3 codes were grouped into themes with a central organizing concept and agreed descriptor, and each article was repeatedly re-examined for instances of the emerging themes; and 4 candidate themes were reviewed in relation to the whole dataset and data comparison was used to check for relationships between themes.
Ten themes and two overarching themes were iteratively developed and agreed by all four researchers. Representative quotes for each theme were also agreed. We JHS, GT agreed on the credibility, dependability, confirmability, and transferability of each report graded low, moderate, high for each componentand then categorised each primary study overall as trustworthy, reasonably so, or uncertain. In confirming each theme we noted what proportion of papers and data originated from primary reports and the overall quality rating and whether the data from the primary studies were congruent with that from first person accounts.
Sixty-six full papers were retrieved, of which 29 were included. Seven of 10 further papers identified from reference lists and scoping searches were included. On the other hand, acquisition of new skills or technology as required for some clinical trials may lead to their systematic application and outcome improvements throughout an institution or health system.
There is evidence that the training and quality assurance associated with a large study in the Netherlands of a new colorectal cancer surgical technique led to rapid improvement in national outcome statistics [ 3 ]. The other component of infrastructure is that of human capital. Physicians, nurses and other allied health professionals that practice in research-active environments may be systematically different than their peers in non-research-active settings and may deliver better care.
This may be as a result of personal characteristics, multi-disciplinary collaboration, additional training and education, or through specialization. In oncology, there are some data to support a volume outcome relationship for certain surgical procedures with respect to both institutions [ 4 ] and providers [ 5 ], but the literature has not been consistent [ 6 ]. For ovarian cancer specifically, evidence suggests that outcomes may be better when patients are managed by gynaecologic oncologists, but once again this is not a consistent finding across all studies [ 7 ].
However, there are no data to show that high volume or very specialized institutions or providers are more likely to be research active. Research active institutions or providers may be more likely to follow clinical guidelines or may be faster to uptake new evidence into practice.
A study in patients with acute coronary syndromes showed that compliance with clinical guidelines was better and mortality was lower among patients treated in institutions that participated in clinical trials in acute coronary syndromes despite the fact that very few patients actually participated in trials in any given institution [ 8 ].
In ovarian cancer, a study from Germany showed that patients treated in institutions that participated in clinical trials had more complete surgical staging and debulking and had better survival than patients treated in institutions not participating in clinical trials [ 9 ].
In contrast, another study which evaluated the impact of participation in a pharmaceutically sponsored clinical trial in asthma showed that trial participation did not influence guideline adherence but did increase use of drugs made by the sponsor [ 10 ]. However, surveys of institutions [ 11 ] or providers [ 12 ] that participated in a particular clinical trial have reported that the quality of care improved as a result of taking part in the trial.
Other potential benefits of research activity The value of negative clinical trials is easily overlooked, but some are especially important in terms of the costs, resource use, and side effects that are commonly associated with newer, more technological, or more complex interventions.
While it may be challenging to estimate the impact of not adopting interventions that are found to be ineffective or no more effective than prior standardsthe research that provides this evidence could be argued to provide indirect benefit to all relevant patients, both within and outside of the participating sites.
Additionally, the implementation of clinical research programmes within an institution, region or nation is assumed to be helpful in retaining outstanding and gifted clinicians and scientists, who might otherwise be attracted elsewhere.
An active research environment should also serve to promote collaborative research with the commercial pharmaceutical, biotechnology and medical device sectors, which generates wealth within the relevant community. However, these relationships may be quite challenging to demonstrate, and we are not aware of any robust relevant data. Broadly, at the heart of understanding the relationship between research and its impact, whether through infrastructure, processes of care or other areas such as knowledge generation, lies complex adaptive systems theory [ 13 ].
Such a framework is capable of integrating the myriad of socio-political and socio-cultural forces at work with sensitivity for both temporal and emergent phenomena.
The underlying assumption of this approach is that medical research is shaped through interactions within a social system; and that flexibility offers a direct measure of complexity [ 14 ].
The main advantage is that socio-cognitive complexity of research is more easily observed and measured, and is always situated in context. Thus if such models for studying complex systems as cancer research and patient outcomes are available what has held back their application? The short answer is that there are blocks both in policy and epistemological terms.
How may clinical research improve healthcare outcomes? | Annals of Oncology | Oxford Academic
In the case of the former the use of evidence-based policy remains a relative nascent approach in cancer. Opinion-based policy making is the dominant culture and that holds as self-evident a positive relationship between research activity and better outcomes.
There has been, until relatively recently little challenge to this normative construct. In much the same way as collaboration has been held to be self evidently good for research productivity, the positive link between research and better patient outcomes has also been accepted. In the case of the former, however, empirical research has demonstrated collaboration to be a very mixed blessing [ 16 ]. Cancer research provides a rich arena for studying infrastructural changes associated with surgery-imaging-pathology; radiotherapy; medicines and organisational aspects such as multi-disciplinary care.
The informants were also agents in the shaping of the data, the data-collecting opportunities, and the course of the fieldwork. The closeness will often, with time, generate an openness and permissiveness, which may imply seemingly endless learning opportunities. However, the dependence on the close relationships with the informants simultaneously sheds light on the precariousness and vulnerability not only of the informants, who may have difficulties controlling the information ultimately generated from the research, but the vulnerability of ethnography as a research approach, as well as the vulnerability of the ethnographer in the process of learning.
In the current study, the researcher gradually gained access to more domains, and later fieldwork revealed the immense impact of her own position for the knowledge gained. She was provided with extensive access to the women's ritual reproductive sphere after being married, giving birth, breastfeeding etc.
The gaining of closeness to the field is thus part of a process of becoming more knowledgeable about culture and context, the handling of language and codes, and of the continuous building of what is often experienced as true friendship. This point pertains to all qualitative research endeavours, but is particularly pertinent in ethnography with its common demands for long-term interaction.
In the study, we considered the experience of being gradually more at ease with the continued outsider role, the learning process made the researcher more of an insider. In a similar vein, we have indicated that the role of researchers as interviewers in the in-depth interview studies and in the focus group discussion studies were not fixed during the course of the interviews. Shifts took place both in relation to definition of the relevant body of knowledge, and the particular position of the researcher in knowledge production.
The vulnerability in designs with especially demanding inherent dual roles In the final example, we shed light on how researcher vulnerability seemed to be part and parcel of the dual role of the researcher. In the pedagogical study empirical example 6the researcher simultaneously pursued the researcher role and the actor role, portraying a patient during communication training. Two focus group interviews with medical students were conducted after the communication training.
The character of the SP was a young woman. She was shy, almost nonverbal, someone who gets very easily hurt and starts crying when challenged on personal matters.
Glossary of Clinical Research Terms
To portray this patient was demanding, and the actress had to use most of her proficiency and skills as an actor to create a credible character. This created an ambivalent situation; she felt emotionally drained after the performance, and found it difficult to shift from the role of the actress to the role of the researcher who moderated the group interviews.
Role confusion of both parties could contribute to an unsharpened reflection. As Malacrida statespp. It puts the researcher at risk of becoming emotionally drained Dunn, ; Lalor et al. To take on the dual role as researcher and SP in the development of this particular pedagogical practice exacerbated the emotional challenge, and made it difficult to find a balance between insider—outsider positions Burns et al.
Parallels to the vulnerability inherent in the participant observer role in the ethnographic study are present, particularly the feelings of being at the mercy of the participants. The manner in which the researchers opened themselves to exposure placed them in a vulnerable position.
In an ethnographic context, the researcher will commonly have a long-lasting relationship with the study participants, which implies opportunities to re-evaluate the course of events and modify ways of approaching demanding topics and situations. This was not the case in the pedagogical project which enhanced the sense of overall vulnerability.
Concluding remarks In this article, we have made an attempt to shed light on the researcher—researched relationship in different qualitatively anchored studies carried out within health science. Flyvbjerg, cited in Karnieli-Miller et al.
In this article, we have anchored our analysis of shifts and ambivalence in the researcher—researched relationship by drawing upon concrete examples from our own research.
The four main qualitative approaches represented; the phenomenological in-depth interview studies, the focus group discussion studies, the ethnographic study, and the pedagogical study, held a common aim of diminishing the distance between the researcher and the researched, and creating an anti-authoritative researcher—researched relationship.
The scenarios that emerged challenged the researchers partly to re-think the research agenda, but it also rendered them vulnerable to substantial emotional stress. The dual role as insider and outsider, participant and researcher, added to the challenge. The empirical examples in this article indicate that these are points of relevance for qualitative research projects, across designs and traditions.
In order to handle shifts in positions between research parties, shifts which are intertwined with ethical dilemmas, the practice of continuous reflexive awareness is paramount. The same holds true for the context of knowledge production; scrutinizing critically what can be at stake in the encounters between researcher and researched, and one's own role in knowledge production.
We argue that sharing and discussing these concerns in research teams and groups, where senior researchers as well as novices meet, should be regular practice. The value of reflexive self-awareness among researchers has been contested. However, along with Finleyp. Although fraught with ambiguity, a lack of critical awareness about the impact of the research context, perspectives chosen, methodological choices made, and, in this context, the presence of the researcher, might seriously hamper the knowledge claims made.
Finally, we support Malacridap. The first and the last author planned the group discussions together and were discussion partners between the group discussions.
All participants were engaged in the group discussions, contributed to developing the core topics, and took part in writing the manuscript. The last author was more involved in writing the article than the authors in the middle. Conflict of interest and funding The authors have not received funding or benefits from industry or elsewhere to conduct this study.
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