Comparison of the assessment of five new interventional procedures in different countries
The aim of this study was to identify and compare health technology assessments of the same new interventional procedures produced in different countries.
We selected five new interventional procedures and studied related assessments produced in different countries.
There were twenty assessments (range, 3-5 per procedure) from nine countries--fourteen from Australia, Canada, and United Kingdom. The number of primary RCTs cited by the assessments ranged from 0 to 13. In the assessment reports, "headline" statements about the strength of evidence for efficacy (73 percent) were made more frequently than for safety (53 percent). These statements were scored for their apparent judgment of the strength of the evidence--1 (poor) to 5 (strong)--and received scores of 3 or less in all but four cases. Recommendations about additional research were included in 55 percent of the assessments. Statements in assessments about other aspects of use of the procedures were included more infrequently--in 35 percent for patient selection, in 20 percent for consent issues, and in 15 percent for types of clinical teams. Recommendations about appropriate healthcare settings, or about operator training, were included only in assessments produced by a single organization.
There was a only small number of assessments world-wide, for a range of new procedures with potentially high impact. Where available, assessments were produced on a relatively poor evidence base. International collaboration in evidence appraisal and review, and in the gathering of new data through research or registers, could improve the advice available to healthcare systems worldwide about the adoption of new interventional procedures.
Available from: Rodrigo Oliva Perez
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ABSTRACT: More than 235 million patients undergo surgery every year worldwide, but less than 1% are enrolled in surgical clinical trials--few of which are international collaborations. Several levels of action are needed to improve this situation. International research collaborations in surgery between developed and developing countries could encourage capacity building and quality improvement, and mutually enhance care for patients with surgical disorders. Low-income and middle-income countries increasingly report much the same range of surgical diseases as do high-income countries (eg, cancer, cardiovascular disease, and the surgical sequelae of metabolic syndrome); collaboration is therefore of mutual interest. Large multinational trials that cross cultures and levels of socioeconomic development might have faster results and wider applicability than do single-country trials. Surgeons educated in research methods, and aided by research networks and trial centres, are needed to foster these international collaborations. Barriers to collaboration could be overcome by adoption of global strategies for regulation, health insurance, ethical approval, and indemnity coverage for doctors.
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The aim of this study was to analyze the experience of the National Institute for Health and Care Excellence (NICE) in identifying new procedures entering the United Kingdom (UK) healthcare system, for assessment and publication of recommendations on their use. This system is designed to provide guidance in an area where regulation is lacking worldwide.
Retrospective analysis of all procedures notified to the Interventional Procedures Programme (NICE) between 2002 and 2012. Notifications were analyzed year by year for their source (who notified them), clinical specialties involved, and whether guidance was subsequently published.
A total of 1,094 procedures were notified by clinicians (51 percent), and by others, including hospitals (6 percent), horizon scanners (5 percent), patients (4 percent), private health insurers (4 percent), and medical device manufacturers (3 percent). Guidance was published on 44 percent of procedures notified to the program. There was a decrease in the numbers of procedures notified during 2003-2012 (p = .049). There were notifications across all specialties, with the largest numbers in general surgery (125), urology (104), orthopedics (99), interventional radiology (93), cardiology (82), and obstetrics and gynecology (82).
The "open" NICE Web portal allows anyone to notify new procedures, aiming to maximize the opportunity of identifying all those procedures entering clinical practice. This has resulted in identification of large numbers of procedures from across the whole range of medical specialties. The fact that similar proportions of procedures notified from diverse sources have been selected for assessment and publication of practice recommendations suggests that this inclusive approach is worthwhile.
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