Objectives: 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.

Methods: 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.

Results: 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).

Conclusions: 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.

Background: Keeping clinical practice recommendations up-to-date with a continually evolving evidence base presents challenges. Resources required to update recommendations compete with those needed to evaluate newer treatments.

Methods: We describe an approach developed by the UK National Institute for Health and Clinical Excellence (NICE) for updating clinical practice recommendations for new interventional procedures and we evaluate relevant initial experience of using this system. Depending on whether evidence for a procedure is judged adequate or inadequate for safety and efficacy, use in clinical practice is usually recommended with either “normal” or “special” arrangements for patient consent, data collection and institutional oversight, respectively. We examined whether differences in the state of the evidence at the initial and the updated appraisal of procedures were associated with changed recommendations.

Results: Since 2008, updating of recommendations focuses on procedures with initially inadequate evidence. “Special arrangements” recommendations about eleven procedures were updated after 3.3–6.5 years (median, 5.3 years), and recommendations for six were changed to “normal arrangements.” Overall, procedures with changed (“special-to-normal”) recommendations had a greater increase in the number of patients included in observational studies published since the initial guidance.

Conclusions: Procedures with changed (“special-to-normal”) recommendations generally had greater increases in their evidence base. Although uncertainties about optimal methods for keeping evidence-based recommendations up-to-date remain, this experience should be useful to policy makers in developing processes for prioritizing scarce resources for updating clinical practice recommendations. Further studies are needed about the value placed on “updated” recommendations by clinicians, policy-makers, and patients.

Objectives: The aim of this study was to identify and compare health technology assessments of the same new interventional procedures produced in different countries.

Methods: We selected five new interventional procedures and studied related assessments produced in different countries.

Results: 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.

Conclusion: 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.

Objectives: Technology assessment systems for interventional procedures (including surgical operations, minimally invasive procedures, and others) have lagged behind those for pharmaceutical treatments. Such systems have been introduced in some countries during the past decade amid debate about how they should be organized, but there is no collated information about where they exist or how they work. This study was designed to provide hitherto unavailable information about the existence, organization, methods, and outputs of systems aimed at influencing the use of interventional procedures in different countries.

Methods: Data were gathered from a questionnaire survey of key informers associated with healthcare technology assessment (HTA) organizations in different countries.

Results: Responses were received from key informers working for twenty-eight HTA organizations in twenty-five countries (response rate 83 percent). Information about a national system for assessing interventional procedures was obtained for fifteen countries. There was substantial variability in the type and funding of these organizations, the systems used for the selection of procedures, the types and sources of evidence used, the personnel involved in the appraisal of the evidence, the arrangements for consultation on the draft assessment, the format of assessment recommendations, the status of the guidance, and the use of guidance from other countries.

Conclusion: Guidance on interventional procedures is produced variably in different countries—and not at all in some. Greater international collaboration in the assessment of new interventional procedures could help to optimize the efficiency of existing systems as well as the quality of the assessments, by capitalizing on the outputs from scarce (international) resources and expertise.

Objectives: The aim of this study was to examine potential associations between the professional background and experience of expert clinicians and their opinions about the clinical utility of interventional procedures.

Methods: A retrospective survey of expert clinician characteristics and their opinions was conducted. Information was collected on expert clinical adviser self-declared “operator,” “researcher,” and conflict of interest status. Associations were sought between expert clinical adviser characteristics and their opinions on whether procedures were “established,” “efficacious,” and “safe.” The setting was the Interventional Procedures Programme of the UK's National Institute for Health and Clinical Excellence (NICE). A total of 598 expert clinician questionnaires relating to 182 different interventional procedures were analyzed.

Results: Expert clinical advisers with operative experience of procedures were significantly more likely to consider them as established (odds ratio [OR] 3.93; 95 percent confidence interval [CI], 2.43 to 6.36; p < .001), efficacious (OR 1.76; 95 percent CI, 1.00 to 3.08; p = .049), and safe (OR 2.28; 95 percent CI, 1.43 to 3.65; p = .001). Once adjusted for other characteristics, there was no association between either researcher or conflict of interest status and opinions about the clinical utility of procedures.

Conclusions: Expert clinical advisers are an important source of information for decision makers producing guidance about the use of procedures, especially when published evidence is sparse or of poor quality. This study suggests that those who are operators, but not those who are researchers or declare a conflict of interest, are more likely to have a favorable opinion of a procedure's clinical utility. Use of expert clinical advisers with a variety of experience and backgrounds seems a reasonable approach to obtaining authoritative opinions about interventional procedures, to supplement and help interpret evidence from published data.

Objectives: The association between type and amount of clinical evidence and type of National Institute for Health and Clinical Excellence recommendations for interventional procedures was examined.

Methods: The evidence about 736 studies (including 183,729 patients) relating to 130 different interventional procedures and about relevant recommendations was analyzed. Associations were examined between type of recommendation (“normal arrangements” or “cautionary guidance”) and evidence type, total number of treated patients, and mean follow-up length. Evidence type was categorized as (a) randomized, (b) nonrandomized controlled, and (c) case series/reports. The main outcome measures were frequency of evidence type, total number of patients treated, and mean follow-up length, by type of recommendation.

Results: “Normal arrangements” recommendations were made for 70 (54 percent) procedures and “cautionary guidance” was issued for 60 (46 percent) procedures. Procedures supported by at least one randomized study (34 percent, n = 44) were more likely to receive a “normal arrangements” recommendation (relative risk 1.38, p = .063). Overall, there were 85 (12 percent), 135 (18 percent), and 516 (70 percent) studies in categories a–c, respectively. The number of treated patients was significantly larger among procedures with “normal arrangements” (median, 605; range, 26–6,842) than among those with “cautionary guidance” (median, 240; range, 1–3,261; p < .001) recommendation. Mean follow-up length was longer in studies relating to procedures with “normal arrangements” recommendation (median, 16.7; range, 0–84 months) compared with those with “cautionary guidance” (median, 14.6; range, 0–67 months; p = .160).

Conclusions: Procedures supported by randomized studies, and with larger numbers of patients and longer follow-up length, were more likely to receive positive guidance. Future research and development on interventional procedures should aim to produce better and more relevant evidence to optimize the possibility of such procedures being accepted by policy makers.

We present a case of pulmonary embolism that occurred during the injection of lipiodol during transcatheter arterial chemoembolization under general anaesthesia. A 7-year-old child suffering from a large hepatoblastoma was admitted for arterial chemoembolization and carcinostatic administration. Pulmonary embolism due to lipiodol during arterial chemoembolization was evident by a sudden fall in oxyhaemoglobin saturation from 100 to 90%. This was associated with a spread of lipiodol into both lungs, particularly the middle lung zones and detected by chest fluoroscopy. Arterial blood gases returned to normal values 1 day later but pulmonary infiltration persisted for 7 days before final clearance. Pulmonary embolism caused by lipiodol during arterial chemoembolization is infrequent, but such a complication could prove fatal. Understanding the risk of pulmonary embolism in patients receiving lipiodol, during and after arterial chemoembolization, and late onset pulmonary injury is important and a close follow-up for several days after arterial chemoembolization is advisable.