Final dissertation, worth 60 M-level credits, to demonstrate students’ capacity to conduct and report a major piece of research work
Final dissertation, worth 60 M-level credits, to demonstrate students’ capacity to conduct and report a major piece of research work
Literature review
As part of a Health Technology Assessment (HTA) review of ethical issues in the design and conduct of RCTs, Edwards et al (1998) identified 58 studies of the views of patients, the public and healthcare professionals on clinical trials. The earliest of these studies dated back to 1969 and just four arose from the 1970s. Seventeen studies were published in the next decade followed by approximately twice that number in the 1990s, up to the time of the HTA review. During the last ten years or so, many more articles have been written on various aspects of clinical trial participation. In line with an increasingly consumer-orientated National Health Service, much of this literature has focused on the patient perspective in clinical trials and on ways of strengthening user involvement in clinical research. Some studies have examined participants' grasp of research terminology and appreciation of methodological concepts such as randomisation and blinding. Others have explored participants' expectations and experiences of randomised controlled trials. Certain topics, such as the comprehensibility and degree of recall of participant information leaflets and the concept of the "special patient" (i.e. the notion that people "do better" in clinical trials) have been widely investigated. In contrast, the subject of dissemination of clinical trial results to participants has received relatively little attention.
Journal articles and other relevant sources of information were identified by a search of the literature relating to disclosure of research results to clinical trial participants. This included an electronic literature survey of the MEDLINE, CINAHL Plus and British Nursing Index (BNI) databases; review of relevant guidelines including the Research Governance Framework for Health and Social Care (Department of Health, 2005) and guidance for Research Ethics Committee (REC) applicants (COREC, 2005a); personal contacts; personal communications and a further examination of reference lists obtained from all of these sources. The search revealed approximately twenty journal articles devoted exclusively to disclosure of clinical trial results though mention of the subject was made in several articles about other aspects of trial participation. Much of the literature is associated with oncology clinical trials and at least half relates to non-UK based research.
In her study of the impact of trial participation on people recruited to oncology trials, Cox (1999) seems puzzled to find that participants "consistently" wanted information about the trials they had taken part in. Rather than acknowledging that participants might simply be curious about the results or feel entitled to receive them, Cox suggests that their request for feedback was a way of establishing some meaning for having taken part in a trial:
"Honouring the request for feedback about the trial outcome may be one way to support patients' search for meaning and promote psychological well being."
Since Cox's study, there has been increasing evidence that participants want to know the results of clinical trials (Cockayne, 2005; Madsen et al, 1999; Madsen et al, 2000; Markman, 2006; Partridge et al, 2003; Partridge et al, 2005) accompanied by a growing realisation amongst investigators that their patients want to be provided with this information (Partridge et al, 2004). Nevertheless, the main focus for providing information to participants is still before and during a trial, with little emphasis as yet on revealing to individuals at the end of a trial what researchers have learned that may benefit future patients (Fernandez et al, 2003; Markman, 2006).
One explanation for this anomaly is that RECs have traditionally required investigators to (i) provide trial participants with comprehensive information at the informed consent stage and (ii) to notify participants of any new and relevant information that emerges during a trial which may affect their wish to continue in the trial. Until recently there has been little REC guidance on disseminating results at the end of trials and researchers have rarely taken it upon themselves to address the issue. However, the recently revised REC application form (COREC, 2005a) suggests that it is good practice for applicants to inform research participants of the study results:
"This provides feedback to participants on the outcome of research towards which they have contributed. Consideration should be given to providing a summary sheet of the findings or letting participants know where they can access the results."
However, it transpires that in some circumstances participants may not want feedback (Partridge and Winer, 2002), possibly because of lack of interest in the research question or because not all trial results have direct implications for individual participants. When Dixon-Woods et al (2006) offered approximately 9,000 participants of a trial of antibiotics in pregnancy a summary of the results, only 1524 (17%) women took up the invitation. Conversely, and albeit that their sample was much smaller, Partridge et al (2005) reported that 85 of 94 (90%) women requested results of a breast cancer trial which had been halted prematurely due to the degree of local disease recurrence amongst participants. These examples suggest that participants may be more interested in the outcomes of trials in which the results have a direct impact on their current or future clinical care than in those which may be of no personal benefit.
A very well written, concise and interesting literature review which establishes both the context and the rationale for the study being undertaken. Evidence is well presented and appropriate analysis is offered where relevant. The style is varied, fluent and authoritative.
In carrying out a literature review, it is good practice to start by describing any previous reviews of the literature which might be relevant. Here the previous review is neatly summarised, demonstrating that the volume of studies on perceptions of clinical trials was increasing to 1998. The area of the previous review overlaps with but is not identical to the area of interest in this review.
This is essentially a methods section for the literature review. The range of sources used is appropriate for a literature review at this level. Use of personal contacts and communications strengthens this literature review, showing that the student has the confidence to contact other researchers with enquiries about their work.
This is essentially a brief summary of the findings of the literature review. The sentence also works implicitly as a signpost that the following paragraphs will consider individual studies from among these findings.
This sentence again is descriptive of a tendency in the previous studies but also reveals more about the topic of the present research.
This describes evidence, contrary to established good practice, that some patients may not want to know the outcomes of trials. The use of two sentences beginning with "however" in close succession should be avoided, as it obscures the line of argument. In fact this sentence does not strictly contradict the previous one. It might be good practice to provide feedback and some patients might still choose not to have it. Therefore the writer could perhaps have begun this paragraph: "It does not follow that all patients will want feedback when it is provided."
Here the student introduces an abbreviation in the appropriate way, by writing the phrase out in full (capitalised) and enclosing the abbreviation in brackets. The abbreviation can then be used without being spelled out in full. The abbreviation RCT (Randomised Clinical Trial) was explained in a short glossary at the start of the dissertation, along with a number of other abbreviations used throughout the report, and so does not need to be written out again. In a long piece of writing a glossary can be an economical way of dealing with abbreviations.
The formulation "Some" Others"" is a useful one for indicating a range of different points of view or topics of study. The student is not claiming to have covered all the topics of the previous studies but to have given an indication of their range and of some key areas of interest. Notice that the three sentences all have essentially the same construction and meaning, but by using different verb phrases ("have examined, "have explored" and "have been widely investigated") the writer maintains the variety and flow of the writing. As is appropriate in writing at this level, the student uses technical terms fluently and without unnecessary explanation, but where a less widely known term is introduced ("special patient"), uses parentheses to explain briefly how this term is being used.
The student comments on a trend in previous studies and offers an explanation for it.
This is an apparently simple, though concise and well expressed summary, of an earlier trial. As is often the case with writing at this level, however, the student is also making an implicit analysis of the earlier study. (At MSc level, markers will be looking for evidence of analytical thinking even in passages with quite descriptive functions.) The writer is using a mild degree of irony to suggest that the previous author should not have been "puzzled" by her findings but should rather have attributed them to participants" natural curiosity or sense of entitlement. Mild irony of this kind can add flavour to a piece of writing but should not be overused, as it implies a sense of superiority that may not be appropriate.
The writer speculates on one reason for the tendency just described. Where the reason offered is as convincing as in this case, there is no need to offer any further reference or authority for it. This pattern of introducing a brief description of evidence, followed by an explanation of the evidence in terms of the topic of current interest, is typical in a good literature review.
This is a valid and useful explanation for the evidence described.
This sentence has two purposes. It summarises the previous review of literature in relation to the topic of the current dissertation, and it provides a rationale for the research undertaken by the student, since previous studies have not tended to prioritise the question under investigation.
This is good use of referencing and a well-balanced sentence in which two tendencies in the previous studies are linked together. Implicitly, there is a connection between patients" desire to know the results of trials and researchers" recognition of it.
Wrasse is released under the terms of the Creative Commons Licence
Information Governance Policies
© Copyright 2024 - Plymouth University & Learn Higher
