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 and associated adverse events of laser vaporisation techniques compared to TURP in men with moderate to severe bothersome LUTS considering surgery for bladder outlet obstruction?
Assessed by symptom severity, quality of life, and adverse events.
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 potential advantages of reduced blood loss, shorter hospital stay and earlier return to normal activities make laser vaporisation techniques attractive to patients and healthcare providers although there is uncertainty around degree of symptom improvement and improvement in quality of life in the short and longer term.
Relevance to NICE guidance
How would the answer to this question change future NICE guidance (that is, generate new knowledge and/or evidence)?
NICE cannot give clear guidance on this intervention because the evidence base is inadequate. The proposed research will add new knowledge.
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)?
Green Light laser use in the NHS is increasing at a rapid rate with approximately 70 units in the UK using it (~ 60% NHS and ~ 40% private sector) from personal communication with representatives of American Medical Systems Inc and clinical units. This is despite a lack of clinical and cost-effectiveness data to support this practice.
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.
None
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.
A recent NCCHTA commissioned systematic review suggests that TURP should remain the standard of care and specifically that green Light Laser was unlikely to be cost-effective in the economic model and thereby arguing against its unrestricted use in the NHS until further evidence of effectiveness and cost-reduction is obtained 19,172-174.
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?
Not applicable
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.
Primary research (RCT). Comparator is TURP. Careful consideration must be given to treatment strategies within the trial design such as incorporating early versus delayed intervention.
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?
Proposed research can be carried out in a realistic timescale and at an acceptable cost. There are no ethical issues. A potential risk is that KTP laser vaporisation use may diminish without adequate assessment.
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.
NCCHTA would be the obvious funder
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

From: Appendix G, Recommendations for research

Cover of The Management of Lower Urinary Tract Symptoms in Men
The Management of Lower Urinary Tract Symptoms in Men [Internet].
NICE Clinical Guidelines, No. 97.
National Clinical Guideline Centre (UK).
Copyright © 2010, National Clinical Guideline Centre.

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