An example demonstrating successfully the importance of balance was a urology study of interventions for prostate cancer surgery vs radiotherapy vs observation. Key aspects of balance were to ensure that all aspects of a trial are presented in similar detail, and with similar enthusiasm. Balance is particularly problematic when a study involves both a radical i. A similar approach may be translated into trauma surgery, with interventions such as surgery versus conservative treatment, better presented as surgery versus individualised exercise therapy or similar.
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An aversion to randomisation is another barrier among patients. Researchers within the prostate cancer study identified that whilst patient aversion to randomisation was a concern, this was more often a subtle effect of a lack of clinician equipoise. Whilst there may be some patients who genuinely have reservations concerning the process of randomisation, the suggestion is that this barrier is frequently a symptom of other barriers i.
Intervention concealment, or blinding, and the use of placebos, or sham surgery, may also pose particular difficulties and concerns for patients in surgical trials. Sham procedures are sometimes used, and these may have elaborate designs, such as in the case of the large knee arthroscopy trial. Ethical difficulties and patient concerns remain a key issue for trials using blinding or placebo interventions in surgery.
Some of the barriers experienced by patients may be overcome by providing adequate materials to enhance their understanding. These must be used carefully to provide factual and well-balanced information. The provision of information is known to be an intervention which may maximise recruitment, with evidence suggesting that increasing the awareness of the disease under investigation i.
Terminology may be a barrier amongst patients. This may therefore not convey the methodological rigour, scientific support and ethical review that have undoubtedly occurred in order to enable the trial to proceed. This barrier may appear trivial, yet is nevertheless real, and researchers may be so engrossed within their study that they miss such subtle barriers.
Other generic patient barriers must also be considered, including the time required for participation and the financial cost to patients, through repeated hospital attendances. Alternative forms of contact may be considered, such as mail or electronic communications, although the effect that these may have on patient follow-up and retention must be considered.
Diseases, or specific patterns of trauma, may generate their own specific barriers.
Disease frequency is perhaps the most obvious barrier, as studies of rare conditions are undoubtedly more difficult to undertake, yet nevertheless the societal burden from such diseases may be great. Ensuring the optimal number of patients within studies may require the involvement of multiple centres, or longer trial recruitment periods, in order to ensure that adequate statistical power is achieved. An alternative is to accept a reduced statistical power i.
Feasibility studies are therefore an integral part of clinical research, in order to determine the likely numbers of patients available for recruitment, and to ensure that recruitment rates are maximised amongst eligible patients. The predilection of diseases for certain social groups is also a barrier to clinical research. Population data suggests that major trauma occurs in men, in socioeconomically deprived groups, and in minority enthic groups. Higher drop-out rates of participants must be anticipated by accounting for these in power calculations, and ensuring maximal recruitment and follow-up in the feasibility stages of trial design.
Specific modalities of follow-up may have different successes, amongst individuals with different diseases - it appears unlikely that those with major trauma would respond well to web-based follow-up, and similarly, attempting to measure outcomes at distant time-points appears unlikely to yield research success. The culture of research within different medical specialties is very different, and a strong research culture undoubtedly drives research success.
The comments by the editor of The Lancet on poor surgical trial outputs, undoubtedly reflects the absence of a research culture within surgery. This is thought to be a consequence of closer monitoring of disease amongst participants. This provides a new opportunity to deliver cheap, efficient and large-scale clinical trials by allowing randomisation of interventions within established national cohorts or audits, 32 , 33 with follow-up made using routinely collected outcome data.
Consent is considered by many as a barrier to clinical research, especially for prospective studies of trauma care. However, consent in research has been considered essential since outrage erupted after a long-term study of the natural history of syphilis failed to treat participants after the discovery of antibiotics; the aim was to understand the natural history of untreated disease. There is a strong argument to suggest that low-risk studies, particularly those comparing interventions already in common use, should adopt an opt-out approach, 36 though debate continues. The opt-in consent process may pose a particular problem for trauma patients, as the ability of an individual to understand and consider the interventions posed may be impaired through head injury, pain, shock, medication or numerous another causes.
Similarly, the timescale between presentation and intervention may be short, such that an individual is unable to consider the interventions proposed reasonably. The research protocol must state that consent to remain in the research should be obtained from the individual, or a legally authorised surrogate, as soon as possible. Germany has acted upon this directive most vehemently, requiring a judge to act as the legal representative authorising research. The EU has recognised the shortcomings of their directive, recently announcing plans to revise it in order to better accommodate emergency situations, 40 though some concern remains about whether the changes will be far-reaching enough.
There are a number of trauma studies, including those in orthopaedics, that have successfully used the emergency trauma consent guidelines to good effect. The clinical randomisation of an antifibrinolytic in significant haemorrhage CRASH-II trial was the largest trauma trial to date, with over 20 participants enrolled internationally, investigating the emergency use of transexamic acid in major trauma. When an individual regained competence, formal informed consent was sought for study participation.
An example of this model of consent in orthopaedic trauma is in the Warwick Hip Trauma Evaluation WHiTE Study, which investigates different interventions in fragility hip fractures. Even if research barriers are overcome and the highest quality research is performed, results do not necessarily translate into clinical practice. Surgeons frequently suggest that randomised controlled trials RCTs lack generalisability to individual patients, with this cited as a common reason for the reluctance to accept RCT evidence. Many expand this argument by suggesting that RCTs are too simple to adequately assess the complex nature of surgical interventions, and that there may be many factors or complexities about the intervention as a whole that influence outcomes.
Despite the obvious need for trials in trauma surgery, there is a clear paucity of well-conducted research that has been undertaken. There are many factors that may act to prohibit high quality trials, which may relate to the surgeon, the patient, or the disease under investigation. Equipoise is the key concern amongst treating surgeons, and appears to be the most substantial barrier to research. A united surgical community, who openly acknowledge uncertainty, would be a powerful force to drive research. It is likely that such a group could erode many of the barriers that currently exist, which may lead to the development of robust programs of clinical research.
However, while RCT evidence in trauma is either scarce or of poor quality, the impact of evidence from clinical trials is likely to be limited. Author contributions: D. Perry: Initial author of manuscript. National Center for Biotechnology Information , U. Journal List Bone Joint Res v. Bone Joint Res. Published online Apr 1. Find articles by D. Find articles by X. Find articles by N. Find articles by M.
Author information Article notes Copyright and License information Disclaimer. Correspondence should be sent to Mr D.
Perry; e-mail: ku. Received Jan 22; Accepted Jan This is an open-access article distributed under the terms of the Creative Commons Attributions licence, which permits unrestricted use, distribution, and reproduction in any medium, but not for commercial gain, provided the original author and source are credited.
This article has been cited by other articles in PMC. Abstract The surgical community is plagued with a reputation for both failing to engage and to deliver on clinical research. Cite this article: Bone Joint Res ;—9. Introduction There is a worldwide epidemic of trauma, which now accounts for 5.click
Designing clinical trials in trauma surgery | Bone & Joint Research
Patient barriers Amongst the patient barriers to trial recruitment, treatment preference is arguably the most important. Disease barriers Diseases, or specific patterns of trauma, may generate their own specific barriers. Process barriers The culture of research within different medical specialties is very different, and a strong research culture undoubtedly drives research success. Delivering changes in clinical practice Even if research barriers are overcome and the highest quality research is performed, results do not necessarily translate into clinical practice.
Conclusion Despite the obvious need for trials in trauma surgery, there is a clear paucity of well-conducted research that has been undertaken. Funding Statement D.
- Summer Institute in Dental and Craniofacial Clinical Research Methods!
- Applied Functional Analysis.
- On a Comparison of the Relative Sensitiveness of Telephones.
- Germanys fighting machine;
Perry and X. Griffin are funded through the NIHR clinical lecturer award scheme. Footnotes Author contributions: D. Griffin: Additions to and amendment of manuscript N. Parsons: Additions to and amendment of manuscript M. Costa: Additions to and amendment of manuscript.
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