Criteria for selecting high-priority research recommendations

PICO question

Each research recommendation should be formulated as an answerable question or a set of closely related questions. This should use the PICO framework (patient, intervention, comparison and outcome)
In patients with a continuing suspicion of a hip fracture but whose radiographs are normal, what is the clinical and cost effectiveness of computed tomography compared to magnetic resonance imaging, in confirming or excluding the fracture?
Patient: patients with a continuing suspicion of a hip fracture but whose radiographs are normal
Intervention: Modern Computed Tomography techniques e.g. 64-slice scanners with three dimensional capabilities and spiral multidetector CT (MDCT)
Comparison: Magnetic resonance imaging
Outcomes: Diagnostic accuracy including sensitivity and specificity
Importance to patients or the population.
What would be the impact of any new or altered guidance on the population (for example, acceptability to patients, quality of life, morbidity or disease prevalence, severity of disease or mortality)?
The altered guidance would ensure the availability of accurate diagnosis out of hours and thus promote the benefits of prompt, accurate surgery to all patients in this group – prompt pain relief, lower mortality, enhanced return to independent living, fewer complications and shorter hospital stay.
Relevance to NICE guidance

How would the answer to this question change future NICE guidance (that is, generate new knowledge and/or evidence)?
Demonstration of comparable sensitivity and specificity with MRI would enable CT techniques to be recommended as investigation of first choice in these circumstances.
Relevance to the NHS

What would be the impact on the NHS and (where relevant) the public sector of any new or altered guidance (for example, financial advantage, effect on staff, impact on strategic planning or service delivery)?
Avoiding delay to surgery in hip fracture is cost-effective. The altered guidance would support this objective. CT is in addition available at lower NHS cost than MRI.
National priorities

Is the question relevant to a national priority area (such as a national service framework or white paper)? The relevant document should be specified.
The question has a direct bearing on the Department of Health Best Practice Tariff initiative to achieve time-to-surgery not exceeding 36 hours.
Current evidence base

What is the current evidence base? What are the problems with the current evidence base? (that is, why is further research required?) Reference should be made to the section of the full guideline that describes the current evidence base, including details of trials and systematic reviews. The date on which the final literature search was undertaken should be specified.
There have been no studies comparing the sensitivity and specificity of modern multidetector CT techniques with the current gold standard (MRI) in the diagnosis of hip fracture. See Section 5.5.1 of the Full Guideline.

Does the research recommendation address equality issues? For example, does it focus on groups that need special consideration, or focus on an intervention that is not available for use by people with certain disabilities?
No specific equality issues.
Study design

It should also specify the most appropriate study design to address the proposed question(s). Primary research or secondary research (for example, systematic reviews) can be recommended.
The research design of choice would be a two-stage design comprising (1) an initial small-scale prospective randomised trial to test an agreed minimum percentage variability between methods followed (subject to outcome) by (2) a prospective cohort study using CT alone.

Can the proposed research be carried out in a realistic timescale and at an acceptable cost? As part of cost-effectiveness analysis, formal value-of-information methods may also sometimes be used to estimate the value for money of additional research. Are there any ethical or technical issues?
It should be possible to undertake both elements in a realistic timescale and at reasonable cost. This would not be the case if a full-scale Phase 3 trial (as distinct from a prospective cohort) were considered essential.

It would be ethically necessary to retain the availability of MRI as opt-out gold standard throughout both studies.
Other comments

Any other important issues should be mentioned, such as potential funders or outcomes of previous attempts to address this issue or methodological problems. However, this is not a research protocol.
The ideal study would compare both CT and MRI in the same patients. This is, however, impractical. The proposed research design has some limitations, but does have the potential to provide useful evidence. The alternative of awaiting an “evolutionary” approach to progress in this area is less acceptable.

How important is the question to the overall guideline? The research recommendation should be categorised into one of the following categories of importance:
  • High: the research is essential to inform future updates of key recommendations in the guideline
  • Medium: the research is relevant to the recommendations in the guideline, but the research recommendations are not key to future updates
  • Low: the research is of interest and will fill existing evidence gaps.
The research is of high priority, since its findings have the potential to alter future guidance on the diagnosis of occult hip fracture.

From: Appendix I, High Priority Research Recommendations

Cover of The Management of Hip Fracture in Adults
The Management of Hip Fracture in Adults [Internet].
NICE Clinical Guidelines, No. 124.
National Clinical Guideline Centre (UK).
Copyright © 2011, National Clinical Guideline Centre.

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