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ABSTRACT: OBJECTIVES: The introduction of new interventional procedures is less regulated than for other health technologies such as pharmaceuticals. Decisions are often taken on evidence of efficacy and short-term safety from small-scale usually observational studies. This reflects the particular challenges of evaluating interventional procedures - the extra facets of skill and training and the difficulty defining a 'new' technology. Currently, there is no framework to evaluate new interventional procedures before they become available in clinical practice as opposed to new pharmaceuticals. This paper proposes a framework to guide the evaluation of a new interventional procedure. PROPOSED FRAMEWORK: A framework was developed consisting of a four-stage progressive evaluation for a new interventional procedure: Stage 1: Development; Stage 2: Efficacy and short-term safety; Stage 3: Effectiveness and cost-effectiveness; and Stage 4: Implementation. The framework also suggests the types of studies or data collection methods that can be used to satisfy each stage. CONCLUSIONS: This paper makes a first step on a framework for generating evidence on new interventional procedures. The difficulties and limitations of applying such a framework are discussed.
Health Policy 12/2011; 104(3):234-40. · 1.51 Impact Factor
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ABSTRACT: To investigate how interventional procedures (IPs) are introduced into the British National Health Services and identify areas for improvement in the current process.
Qualitative study using one to one semi-structured interviews. Using the framework approach, the data generated from 14 participants were analysed with coding of emergent themes. Data were analysed separately for providers and commissioner organisations.
Variations were observed in how IPs are introduced from both the provider and commissioner perspectives. Patterns of approaches allowed the development of models reflecting practice at each type of organisation: very structured in some places to, unstructured or almost non-existent in others. Factors affecting the decision to introduce a procedure include: immediate costs and benefits, numbers of people affected, training requirements, NICE guidance, nature of procedure, support from colleagues, incentives, public or policy-maker pressure, and aims of the institution. Monitoring was seen as a key area for improvement by many.
These variations indicate that the process of introducing new IPs in the NHS can be improved. Factors affecting decision-making and problems have been identified. The results of our study could inform and help shape future processes of managing and the introduction of new procedures into the NHS.
Health Policy 04/2011; 100(1):35-42. · 1.51 Impact Factor
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ABSTRACT: To identify how decision-makers in the NHS perceive and manage interventional procedures guidance and to determine whether additional information would be useful.
Qualitative study using semi-structured interviews with seven providers, six commissioners and one policy-maker. The framework approach was used to analyse transcribed data, and emergent themes coded. Data were analysed separately for providers and commissioner organizations.
Perceptions about how guidance is managed in provider organizations varied. Some decision-makers considered that guidance is handled very well whereas others think it is suboptimal and haphazard. It is unclear whether clinicians follow procedure for cautionary guidance. In commissioner organizations, guidance is not seen as a priority by most and is not considered an area that will soon enter routine clinical practice. Moreover, commissioners felt that guidance lacked relevance as there is no consideration of whether procedures are cost-effective or affordable. Despite this, respondents perceived that the content and quality of guidance is satisfactory. Useful additional information for inclusion in guidance would be: prevalence, incidence, cost, patients' views, consequences of using the new intervention, comparative information, effectiveness and cost-effectiveness.
Management of interventional procedures guidance in the NHS can be improved. It is important to understand the ways in which guidance meets and fails to meet decision-makers' needs.
Journal of Health Services Research & Policy 02/2010; 15 Suppl 2:3-11. · 1.73 Impact Factor
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ABSTRACT: Transurethral incision of the prostate gland (TUIP) is perceived as a less morbid surgical alternative to standard transurethral resection of the prostate gland (TURP) for treatment of symptomatic mild to moderate benign prostate enlargement (BPE). We aimed to evaluate comparative clinical effectiveness of the two procedures.
Systematic review and meta-analysis of short- and long-term data from randomised controlled trials comparing TUIP with TURP.
This review considered data from 795 randomised participants across 10 RCTs of moderate to poor quality 8 of which stated an upper limit for prostate size. No difference in the degree of symptomatic improvement was seen between the two procedures. Improvement in peak urine flow rate was lower for TUIP compared to TURP whilst the rate of blood transfusion and TUR syndrome was higher after TURP. Urinary retention, urinary tract infection, strictures and incontinence did not differ between the two approaches, although clinically important differences could not be ruled-out. TUIP was associated with a shorter duration of operation and length of hospital stay but a higher re-operation rate.
TUIP and TURP appear to offer equivalent symptomatic improvement for men with mild to moderate BPE. Choosing TUIP involves a trade-off between the lower risk of peri-operative morbidity and the higher risk of subsequent re-operation.
World Journal of Urology 02/2010; 28(1):23-32. · 2.41 Impact Factor
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ABSTRACT: From the literature search for a government-commissioned systematic review on surgical treatments for benign prostatic enlargement (BPE), we identified the relevant conference abstracts of randomised controlled trials (RCTs) which failed to reach full publication and their data were not utilised. We aimed to ascertain, first, the reasons of failure to reach full publication and second, to estimate the impact of including the abstracts' data.
A two-part study, consisting of a questionnaire survey and a sensitivity analysis of the above said review.
An ad hoc questionnaire was sent to each author of the relevant abstracts, as to determine the reasons of failure to reach full publication. The data from the abstracts were then extracted and incorporated into sensitivity analysis of the review.
Forty-seven questionnaires were completed for 47 abstracts. Of these abstracts, 32 of them were claimed to have reached full publication. A number of reasons of failure to reach full publication were identified, for example: 'being written up' and 'lack of time'. Utilizable, relevant data were obtained from eight of the 47 abstracts, and put into sensitivity analysis. There were small changes in effect sizes and directions for three of 14 reviews' secondary outcomes.
Common reasons of failure to reach full publication were also identified in the context for the BPE review. Inclusion of abstract data did not affect primary outcome defined in the original review. Identification, summarisation of conference abstracts and other grey literature should form an essential exercise for any systematic review.
World Journal of Urology 02/2010; 28(1):63-9. · 2.41 Impact Factor
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ABSTRACT: To compare the effectiveness and risk profile of minimally invasive interventions against the current standard of transurethral resection of the prostate.
Systematic review and meta-analysis of randomised controlled trials.
Electronic and paper records up to March 2006.
We searched for all relevant randomised controlled trials. Two reviewers independently extracted data and assessed quality. Meta-analyses of prespecified outcomes were performed with fixed and random effects models and reported using relative risks or weighted mean difference.
3794 abstracts were identified; 22 randomised controlled trials met the inclusion criteria. These provided data on 2434 participants. The studies evaluated were of moderate to poor quality with small sample sizes. Minimally invasive interventions were less effective than transurethral resection of the prostate in terms of improvement in symptom scores and increase in urine flow rate, with most comparisons showing significance despite wide confidence intervals. Rates of reoperation were significantly higher for minimally invasive treatments. The risk profile of minimally invasive interventions was better than that of transurethral resection, with fewer adverse events. The results, however, showed significant heterogeneity.
Which minimally invasive intervention is the most promising remains unclear. Their place in the management of benign prostate enlargement will continue to remain controversial until well designed and well reported randomised controlled trials following CONSORT guidelines prove they are superior and more cost effective than drug treatment, or that strategies of sequential surgical treatments are preferred by patients and are more cost effective than the more invasive but more effective tissue ablative interventions such as transurethral resection.
BMJ (Clinical research ed.). 02/2008; 337:a1662.
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ABSTRACT: To compare the effectiveness and risk profile of newer methods for endoscopic ablation of the prostate against the current standard of transurethral resection.
Systematic review and meta-analysis.
Electronic and paper records in subject area up to March 2006.
We searched for randomised controlled trials of endoscopic ablative interventions that included transurethral resection of prostate as one of the treatment arms. Two reviewers independently extracted data and assessed quality. Meta-analyses of prespecified outcomes were done using fixed and random effects models and reported using relative risk or weighted mean difference.
We identified 45 randomised controlled trials meeting the inclusion criteria and reporting on 3970 participants. The reports were of moderate to poor quality, with small sample sizes. None of the newer technologies resulted in significantly greater improvement in symptoms than transurethral resection at 12 months, although a trend suggested a better outcome with holmium laser enucleation (random effects weighted mean difference -0.82, 95% confidence interval 1.76 to 0.12) and worse outcome with laser vaporisation (1.49, -0.40 to 3.39). Improvements in secondary measures, such as peak urine flow rate, were consistent with change in symptoms. Blood transfusion rates were higher for transurethral resection than for the newer methods (4.8% v 0.7%) and men undergoing laser vaporisation or diathermy vaporisation were more likely to experience urinary retention (6.7% v 2.3% and 3.6% v 1.1%). Hospital stay was up to one day shorter for the newer technologies.
Although men undergoing more modern methods of removing benign prostatic enlargement have similar outcomes to standard transurethral resection of prostate along with fewer requirements for blood transfusion and shorter hospital stay, the quality of current evidence is poor. The lack of any clearly more effective procedure suggests that transurethral resection should remain the standard approach.
BMJ (Clinical research ed.). 02/2008; 337:a449.
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ABSTRACT: To determine the clinical effectiveness of laparoscopic and laparoscopically assisted surgery in comparison with open surgery for the treatment of colorectal cancer.
Open resection is the standard method for surgical removal of primary colorectal tumours. However, there is significant morbidity associated with this procedure. Laparoscopic resection (LR) is technically more difficult but may overcome problems associated with open resections (OR).
Systematic review and meta-analysis of short- and long-term data from randomised controlled trials (RCTs) comparing LS with OR.
Highly sensitive searches of nine databases identified 19 primary RCTs describing data from over 4,500 participants. Length of hospital stay is shorter, blood loss and pain are less, and return to usual activities is likely to be faster after LR than after OR, but duration of operation is longer. Lymph node retrieval, completeness of resection and quality of life do not appear to differ. No statistically significant differences were observed in rates of anastomotic leakage, abdominal wound breakdown, incisional hernia, wound and urinary tract infections, operative and 30-day mortality, and recurrences, nor in overall and disease-free survival up to three years.
LR is associated with a quicker recovery in terms of return to usual activities and length of hospital stay with no evidence of a difference in complications or long-term outcomes in comparison to OR, up to three years postoperatively.
Surgical Endoscopy 01/2008; 22(5):1146-60. · 4.01 Impact Factor
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ABSTRACT: Objective To determine the clinical effectiveness of laparoscopic and laparoscopically assisted surgery in comparison with open surgery for the treatment of colorectal cancer. Background Open resection is the standard method for surgical removal of primary colorectal tumours. However, there is significant morbidity associated with this procedure. Laparoscopic resection (LR) is technically more difficult but may overcome problems associated with open resections (OR). Methods Systematic review and meta-analysis of short- and long-term data from randomised controlled trials (RCTs) comparing LS with OR. Results Highly sensitive searches of nine databases identified 19 primary RCTs describing data from over 4,500 participants. Length of hospital stay is shorter, blood loss and pain are less, and return to usual activities is likely to be faster after LR than after OR, but duration of operation is longer. Lymph node retrieval, completeness of resection and quality of life do not appear to differ. No statistically significant differences were observed in rates of anastomotic leakage, abdominal wound breakdown, incisional hernia, wound and urinary tract infections, operative and 30-day mortality, and recurrences, nor in overall and disease-free survival up to three years. Conclusions LR is associated with a quicker recovery in terms of return to usual activities and length of hospital stay with no evidence of a difference in complications or long-term outcomes in comparison to OR, up to three years postoperatively. This study was supported by the NHS R&D HTA programme. The Health Services Research Unit and the Health Economics Research Unit are funded by the Chief Scientist Office of the Scottish Executive Health Department. Peer reviewed Author version
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ABSTRACT: Objective To compare the effectiveness and risk profile of newer methods for endoscopic ablation of the prostate against the current standard of transurethral resection. Design Systematic review and meta-analysis. Data sources Electronic and paper records in subject area up to March 2006. Review methods We searched for randomised controlled trials of endoscopic ablative interventions that included transurethral resection of prostate as one of the treatment arms. Two reviewers independently extracted data and assessed quality. Meta-analyses of prespecified outcomes were done using fixed and random effects models and reported using relative risk or weighted mean difference. Results We identified 45 randomised controlled trials meeting the inclusion criteria and reporting on 3970 participants. The reports were of moderate to poor quality, with small sample sizes. None of the newer technologies resulted in significantly greater improvement in symptoms than transurethral resection at 12 months, although a trend suggested a better outcome with holmium laser enucleation (random effects weighted mean difference -0.82, 95% confidence interval 1.76 to 0.12) and worse outcome with laser vaporisation (1.49, -0.40 to 3.39). Improvements in secondary measures, such as peak urine flow rate, were consistent with change in symptoms. Blood transfusion rates were higher for transurethral resection than for the newer methods (4.8% v 0.7%) and men undergoing laser vaporisation or diathermy vaporisation were more likely to experience urinary retention (6.7% v 2.3% and 3.6% v 1.1%). Hospital stay was up to one day shorter for the newer technologies. Conclusions Although men undergoing more modern methods of removing benign prostatic enlargement have similar outcomes to standard transurethral resection of prostate along with fewer requirements for blood transfusion and shorter hospital stay, the quality of current evidence is poor. The lack of any clearly more effective procedure suggests that transurethral resection should remain the standard approach. Funding: Health Technology Assessment programme (project No 04/38/ 03). The Health Services Research Unit and the Health Economics Research Unit are core funded by the Chief Scientist Office of the Scottish Government Health Directorates. The views expressed in this paper are those of the authors not the institutions providing funding. Peer reviewed Publisher PDF
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Tania Lourenco,
Nigel Armstrong,
James Michael Olu N'Dow,
G Nabi,
M Deverill,
R Pickard,
Luke David Vale,
Graeme Stewart MacLennan,
Cynthia Mary Fraser,
Sam McClinton,
S. Wong,
Alasdair George Coutts,
Graham Mowatt,
Adrian Grant,
BPE Study Group
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ABSTRACT: Objectives: To determine the clinical effectiveness and cost utility of procedures alternative to TURP (transurethral resection of the prostate) for benign prostatic enlargement (BPE) unresponsive to expectant, non-surgical treatments. Data sources: Electronic searches of 13 databases to identify relevant randomised controlled trials (RCTs). Review methods: Two reviewers independently assessed study quality and extracted data. The International Prostate Symptom Score/American Urological Association (IPSS/AUA) symptom score was the primary outcome; others included quality of life, peak urine flow rate and adverse effects. Costeffectiveness was assessed using a Markov model reflecting likely care pathways. Results: 156 reports describing 88 RCTs were included. Most had fewer than 100 participants (range 12–234). TURP provided consistent, high-level, longterm symptomatic improvement. Minimally invasive procedures resulted in less marked improvement. Ablative procedures gave improvements equivalent to TURP. Holmium laser enucleation of the prostate (HoLEP) additionally resulted in greater improvement in flow rate. HoLEP is unique amongst the newer technologies in offering an advantage in urodynamic outcomes over TURP, although long-term follow-up data are lacking. Severe blood loss was more common following TURP. Rates of incontinence were similar across all interventions other than transurethral needle ablation (TUNA) and laser coagulation, for which lower rates were reported. Acute retention and reoperation were commoner with newer technologies, especially minimally invasive interventions. The economic model suggested that minimally invasive procedures were unlikely to be cost-effective compared with TURP. Transurethral vaporisation of the prostate (TUVP) was both less costly and less effective than TURP. HoLEP was estimated to be more cost-effective than a single TURP but less effective than a strategy involving repeat TURP if necessary. The base-case analysis suggested an 80% chance that TUVP, followed by HoLEP if required, would be cost-effective at a threshold of £20,000 per quality-adjusted life-year. At a £50,000 threshold, TUVP, followed by TURP as required, would be cost-effective, although considerable uncertainty surrounds this finding. The main limitations are the quantity and quality of the data available, in the context of multiple comparisons. Conclusions: In the absence of strong evidence in favour of newer methods, the standard – TURP – remains both clinically effective and cost-effective. There is a need for further research to establish (i) how many years of medical treatment are necessary to offset the cost of treatment with a minimally invasive or ablative intervention; (ii) more cost-effective alternatives to TURP; and (iii) strategies to improve outcomes after TURP. Chief Scientist Office of the Scottish Government Health Directorate. Peer reviewed Publisher PDF
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ABSTRACT: Objective: To compare the effectiveness and risk profile of minimally invasive interventions against the current standard of transurethral resection of the prostate. Design Systematic review and meta-analysis of randomised controlled trials. Data sources Electronic and paper records up to March 2006. Review methods: We searched for all relevant randomised controlled trials. Two reviewers independently extracted data and assessed quality. Meta-analyses of prespecified outcomes were performed with fixed and random effects models and reported using relative risks or weighted mean difference. Results 3794 abstracts were identified; 22 randomised controlled trials met the inclusion criteria. These provided data on 2434 participants. The studies evaluated were of moderate to poor quality with small sample sizes. Minimally invasive interventions were less effective than transurethral resection of the prostate in terms of improvement in symptom scores and increase in urine flow rate, with most comparisons showing significance despite wide confidence intervals. Rates of second operation were significantly higher for minimally invasive treatments. The risk profile of minimally invasive interventions was better than that of transurethral resection, with fewer adverse events. The results, however, showed significant heterogeneity. Conclusion: Which minimally invasive intervention is the most promising remains unclear. Their place in the management of benign prostate enlargement will continue to remain controversial until well designed and well reported randomised controlled trials following CONSORT guidelines prove they are superior and more cost effective than drug treatment or that strategies of sequential surgical treatments are preferred by patients and are more cost effective than the more invasive but more effective tissue ablative interventions such as transurethral resection. The health services research unit and the health economics research unit are core funded by the Chief Scientist Office of the ScottishGovernment Health Directorates. Peer reviewed
