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)
What is the clinical and cost effectiveness of regional versus general anaesthesia on postoperative morbidity in patients with hip fracture?
Patient: patients undergoing surgical repair for hip fractures
Intervention: regional anaesthesia
Comparison: general anaesthesia
Outcome: postoperative morbidity
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).
Improved survival following hip fracture. Improved analgesia following surgery. Reduced complications such as acute delirium, nausea and vomiting.
Relevance to NICE guidance
How would the answer to this question change future NICE guidance (that is, generate new knowledge and/or evidence)?
The study may give the evidence to give better guidance to anaesthetists. There have been no studies comparing modern anaesthesia techniques in this group of patients. The current evidence is old and unreliable. The hip fracture population is now older and has more comorbidities than the population in which the historical studies were conducted.

The studies are also important to help patients and their carers make informed decisions about the form of anaesthesia most appropriate for them.

Importance : High
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)?
There may be a reduction in length of stay in patients receiving spinal anaesthesia, without sedation. Postoperative recovery should be quicker.
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.
SIGN recommend spinal but without any evidence base. The evidence for benefit is weak and was conducted over 30 years ago.
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.
No trial evidence was identified
Equality
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?
This recommendation does not exclude any patient group. However, special consideration should be given to very frail older people with a high prevalence of cognitive impairment.
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 study design for the proposed research would be best addressed by an RCT. This would ideally have three arms (3000 participants each) which looks at spinal versus spinal plus sedation versus general anaesthsia, this would separate those with regional anaesthesia from those with regional anaesthesia plus sedation. The study would also need to control for surgery, especially type of fracture, prosthesis and grade of surgeon.

A qualitative research component would also be helpful to study on patient preference for type of anaesthesia.
Feasibility

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?
Although the number of participants suggested is relatively high, it is worth considering that there are over 80,000 patients admitted with hip fractures each year. This should be feasible by conducting a multi-centre RCT.
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.
Potential funders include : The National Institute for Health Research (NIHR), ASTRA foundation.
Importance
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.
High. The research is essential to inform future updates of key recommendations in the guideline.

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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