scholarly journals Thulium laser transurethral vaporesection versus transurethral resection of the prostate for benign prostatic obstruction: the UNBLOCS RCT

2020 ◽  
Vol 24 (41) ◽  
pp. 1-96 ◽  
Author(s):  
Jo Worthington ◽  
J Athene Lane ◽  
Hilary Taylor ◽  
Grace Young ◽  
Sian M Noble ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Health Technology Assessment ◽  
Hospital Stay ◽  
Technology Assessment ◽  
Transurethral Resection ◽  
Health Technology ◽  
Mean Difference ◽  
Thulium Laser ◽  
Benign Prostatic Obstruction ◽  
Patient Reported

Background Transurethral resection of the prostate (TURP) is the standard operation for benign prostatic obstruction (BPO). Thulium laser transurethral vaporesection of the prostate (ThuVARP) vaporises and resects the prostate using a technique similar to TURP. The small amount of existing literature suggests that there may be potential advantages of ThuVARP over TURP. Objective To determine whether or not the outcomes from ThuVARP are equivalent to the outcomes from TURP in men with BPO treated in the NHS. Design A multicentre, pragmatic, randomised controlled parallel-group trial, with an embedded qualitative study and economic evaluation. Setting Seven UK centres – four university teaching hospitals and three district general hospitals. Participants Men aged ≥ 18 years who were suitable to undergo TURP, presenting with bothersome lower urinary tract symptoms (LUTS) or urinary retention secondary to BPO. Interventions Patients were randomised 1 : 1 to receive TURP or ThuVARP and remained blinded. Main outcome measures Two co-primary outcomes – patient-reported International Prostate Symptom Score (IPSS) and clinical measure of maximum urine flow rate (Qmax) at 12 months post surgery. Results In total, 410 men were randomised, 205 to each arm. The two procedures were equivalent in terms of IPSS [adjusted mean difference 0.28 points higher for ThuVARP (favouring TURP), 95% confidence interval (CI) –0.92 to 1.49 points]. The two procedures were not equivalent in terms of Qmax (adjusted mean difference 3.12 ml/second in favour of TURP, 95% CI 0.45 to 5.79 ml/second), with TURP deemed superior. Surgical outcomes, such as complications and blood transfusion rates, and hospital stay were similar for both procedures. Patient-reported urinary and sexual symptoms were also similar between the arms. Qualitative interviews indicated similar patient experiences with both procedures. However, 25% of participants in the ThuVARP arm did not undergo their randomised allocation, compared with 2% of participants in the TURP arm. Prostate cancer was also detected less frequently from routine histology after ThuVARP (65% lower odds of detection) in an exploratory analysis. The adjusted mean differences between the arms were similar for secondary care NHS costs (£9 higher for ThuVARP, 95% CI –£359 to £376) and quality-adjusted life-years (0.01 favouring TURP, 95% CI –0.04 to 0.01). Limitations Complications were recorded in prespecified categories; those not prespecified were excluded owing to variable reporting. Preoperative Qmax and IPSS data could not be collected for participants with indwelling catheters, making adjustment for baseline status difficult. Conclusions TURP was superior to ThuVARP in terms of Qmax, although both operations resulted in a Qmax considered clinically successful. ThuVARP also potentially resulted in lower detection rates of prostate cancer as a result of the smaller volume of tissue available for histology. Length of hospital stay after ThuVARP, anticipated to be a key benefit, was equal to that after TURP in this trial. Overall, both ThuVARP and TURP were effective procedures for BPO, with minor benefits in favour of TURP. Therefore, the results suggest that it may be appropriate that new treatment alternatives continue to be compared with TURP. Future work Longer-term follow-up to assess reoperation rates over time, and research into the comparative effectiveness of ThuVARP and TURP in large prostates. Trial registration Current Controlled Trials ISRCTN00788389. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 41. See the NIHR Journals Library website for further project information.

scholarly journals Health technology assessment in evolution – focal therapy in localised prostate cancer

2014 ◽  
Vol 14 (11) ◽  
pp. 1359-1367 ◽  
Author(s):  
Massimo Valerio ◽  
Mark Emberton ◽  
Eric Barret ◽  
Daniel Eberli ◽  
Scott E Eggener ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Focal Therapy

PP120 Health Technology Assessment Framework To Capture The Full Value Of Value Added Medicines

2017 ◽  
Vol 33 (S1) ◽  
pp. 128-129
Author(s):  
Mondher Toumi ◽  
Cecile Remuzat ◽  
Adam Plich
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Drug Repositioning ◽  
Value Added ◽  
Health Technology ◽  
Access To Medicines ◽  
Deliberative Process ◽  
Study Objective ◽  
Healthcare Needs ◽  
Patient Reported

INTRODUCTION:Value added medicines (VAM) are medicines based on known molecules that address healthcare needs and deliver relevant improvements for patients, healthcare professionals and/or payers through drug repositioning, drug reformulation or drug combination (1-3). Recently, the European Commission, through the Safe and Timely Access to Medicines for Patients (STAMP) program, considered the issue of VAM development and regulatory process. Current Health Technology Assessment (HTA) tools may not fully capture the benefits of VAM, which could lead to obstacles for patient access to VAM in several European countries (1). The study objective was to identify how HTA frameworks should evolve to reflect VAM value.METHODS:HTA expert interviews were performed as a preparatory step to an advisory board meeting. The following topics were addressed: (i) Eligibility for HTA and early HTA dialogues; (ii) Attributes that should be considered in HTA; (iii) HTA methodology; and (iv) Involvement of stakeholders in HTA.RESULTS:VAMs bring additional benefit to patients and society. Therefore, the possibility for VAM assessment on a voluntary basis and within the appropriate assessment patterns/tools should be, in principle, included into HTA frameworks, as well as into early HTA dialogues. HTA should be patient-centric, and attributes such as patient preference, adherence, and patient reported outcomes should be considered where relevant. Unmet patient needs and disease burden should be used in a transparent and reproducible deliberative process. All these attributes should be used as explicitly and meaningfully weighted appraisal modifiers. HTA methodology should be comprehensive and should integrate societal perspectives. Patient representatives should take part in the decision-making process.CONCLUSIONS:Current HTA frameworks should evolve to enhance VAM value recognition and encourage industry investment in medicines with high potential value for society.

REPORTS FROM THE CANADIAN COORDINATING OFFICE FOR HEALTH TECHNOLOGY ASSESSMENT (CCOHTA)

1999 ◽  
Vol 15 (2) ◽  
pp. 424-438
Keyword(s):  
Prostate Cancer ◽  
Genetic Testing ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Clinical Relevance ◽  
Molecular Basis ◽  
Health Technology ◽  
Policy Implications ◽  
Nondirective Counseling ◽  
Breast And Prostate Cancer

This qualitative review describes the current molecular basis of breast and prostate cancer, assesses the clinical relevance of genetic susceptibility, addresses nondirective counseling, and explores the ethical, psychosocial, and policy implications associated with genetic testing.

scholarly journals Comparing open and minimally invasive surgical procedures for oesophagectomy in the treatment of cancer: the ROMIO (Randomised Oesophagectomy: Minimally Invasive or Open) feasibility study and pilot trial

2016 ◽  
Vol 20 (48) ◽  
pp. 1-68 ◽  
Author(s):  
Chris Metcalfe ◽  
Kerry Avery ◽  
Richard Berrisford ◽  
Paul Barham ◽  
Sian M Noble ◽  
...  
Keyword(s):  
Minimally Invasive ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Open Surgery ◽  
Outcome Measure ◽  
Pilot Trial ◽  
Health Technology ◽  
Definitive Trial ◽  
Post Surgery ◽  
Patient Reported

BackgroundLocalised oesophageal cancer can be curatively treated with surgery (oesophagectomy) but the procedure is complex with a risk of complications, negative effects on quality of life and a recovery period of 6–9 months. Minimal-access surgery may accelerate recovery.ObjectivesThe ROMIO (Randomised Oesophagectomy: Minimally Invasive or Open) study aimed to establish the feasibility of, and methodology for, a definitive trial comparing minimally invasive and open surgery for oesophagectomy. Objectives were to quantify the number of eligible patients in a pilot trial; develop surgical manuals as the basis for quality assurance; standardise pathological processing; establish a method to blind patients to their allocation in the first week post surgery; identify measures of postsurgical outcome of importance to patients and clinicians; and establish the main cost differences between the surgical approaches.DesignPilot parallel three-arm randomised controlled trial nested within feasibility work.SettingTwo UK NHS departments of upper gastrointestinal surgery.ParticipantsPatients aged ≥ 18 years with histopathological evidence of oesophageal or oesophagogastric junctional adenocarcinoma, squamous cell cancer or high-grade dysplasia, referred for oesophagectomy or oesophagectomy following neoadjuvant chemo(radio)therapy.InterventionsOesophagectomy, with patients randomised to open surgery, a hybrid open chest and minimally invasive abdomen or totally minimally invasive access.Main outcome measureThe primary outcome measure for the pilot trial was the number of patients recruited per month, with the main trial considered feasible if at least 2.5 patients per month were recruited.ResultsDuring 21 months of recruitment, 263 patients were assessed for eligibility; of these, 135 (51%) were found to be eligible and 104 (77%) agreed to participate, an average of five patients per month. In total, 41 patients were allocated to open surgery, 43 to the hybrid procedure and 20 to totally minimally invasive surgery. Recruitment is continuing, allowing a seamless transition into the definitive trial. Consequently, the database is unlocked at the time of writing and data presented here are for patients recruited by 31 August 2014. Random allocation achieved a good balance between the arms of the study, which, as a high proportion of patients underwent their allocated surgery (69/79, 87%), ensured a fair comparison between the interventions. Dressing patients with large bandages, covering all possible incisions, was successful in keeping patients blind while pain was assessed during the first week post surgery. Postsurgical length of stay and risk of adverse events were within the typical range for this group of patients, with one death occurring within 30 days among 76 patients. There were good completion rates for the assessment of pain at 6 days post surgery (88%) and of the patient-reported outcomes at 6 weeks post randomisation (74%).ConclusionsRapid recruitment to the pilot trial and the successful refinement of methodology indicated the feasibility of a definitive trial comparing different approaches to oesophagectomy. Although we have shown a full trial of open compared with minimally invasive oesophagectomy to be feasible, this is necessarily based on our findings from the two clinical centres that we could include in this small preliminary study.Trial registrationCurrent Controlled Trials ISRCTN59036820.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 48. See the NIHR Journals Library website for further project information.

scholarly journals PMU108 ASSESSING THE IMPACT OF PATIENT-REPORTED OUTCOMES IN HEALTH-TECHNOLOGY ASSESSMENT

2020 ◽  
Vol 23 ◽  
pp. S253
Author(s):  
Y.D. Hong ◽  
M. Hennig ◽  
Q. Shen ◽  
R. Alfonso ◽  
H. Kitchen ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Patient Reported Outcomes ◽  
Health Technology ◽  
Patient Reported ◽  
The Impact

VP09 Arthroplasty Registers As A Tool For Health Technology Assessment

2017 ◽  
Vol 33 (S1) ◽  
pp. 150-151
Author(s):  
Laia Domingo ◽  
Olga Martínez ◽  
Jorge Arias ◽  
Joan Nardi ◽  
Lluís Puig ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Revision Rate ◽  
Health Technology ◽  
Decision Makers ◽  
Joint Analysis ◽  
List Type ◽  
Implant Survival ◽  
Joint Replacement Surgery ◽  
Patient Reported

INTRODUCTION:Our purpose is to present the potential for health technology assessment that arthroplasty registers may offer.METHODS:A revision of the health assessment uses and information collected by arthroplasty registers was made. The information provided from international networks like NORE, ISAR and ICOR was also considered. Arthroplasty registers collect data of patients undergoing joint replacement surgery (mainly hip and knee) along with implant information. They provide longitudinal information useful to assess implant survival (expressed as revision rate and calculated from the primary surgery to implant revision). They also data from the surgical procedure and, more recently, a number of registries incorporate patient reported outcomes (PROMs) information.RESULTS:Arthroplasty registers provide information from multiple perspectives: (i)Decision-makers and healthcare providers/authorities: the comparison of revision rates by using funnel plots is a useful methodology to benchmark implants and to identify outliers, or models with significantly different revision rate in comparison to their peers. Besides, data available in registers has proven to be useful to define sets of indicators related to safety, effectiveness, efficiency, patient-centered healthcare and perceived health outcomes.(ii)Surgeons: Some ongoing initiatives, like ODEP, aiming at providing a benchmark rating for implant survivorship, are gaining interest by professionals promoting an evidence-based clinical practice.(iii)Industry: the large amount of data recorded so far may allow obtaining robust information of prosthesis behavior.(iv)Patients: there is an increasing number of registers that incorporate PROMs. Moreover, a growing interest to promote patient engagement in arthroplasty decision making has been observed.CONCLUSIONS:Long-standing arthroplasty registries have untapped potential. Beyond the assessment of implant survival, they have been consolidated as a useful tool for decision-makers, professionals, and patients. Next steps will be to promote joint analysis of national/regional registries to explore uncommon practices or new medical devices, and also to adapt to future regulations on implant traceability.

scholarly journals Evaluating the Benefits of New Drugs in Health Technology Assessment Using Multiple Criteria Decision Analysis: A Case Study on Metastatic Prostate Cancer With the Dental and Pharmaceuticals Benefits Agency (TLV) in Sweden

2018 ◽  
Vol 3 (2) ◽  
pp. 238146831879621 ◽  
Author(s):  
Aris Angelis
Keyword(s):  
Prostate Cancer ◽  
Decision Analysis ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Value Theory ◽  
Multiple Criteria ◽  
Decision Makers ◽  
Multiple Criteria Decision Analysis

Background. Multiple criteria decision analysis (MCDA) has been identified as a prospective methodology for assisting decision makers in evaluating the benefits of new medicines in health technology assessment (HTA); however, limited empirical evidence exists from real-world applications. Objective. To test in practice a recently developed MCDA methodological framework for HTA, the Advance Value Framework, in a proof-of-concept case study with decision makers. Methods. A multi-attribute value theory methodology was adopted applying the MACBETH questioning protocol through a facilitated decision-analysis modelling approach as part of a decision conference with four experts. Settings. The remit of the Swedish Dental and Pharmaceutical Benefits Agency (Tandvårds- och läkemedelsförmånsverket [TLV]) was adopted but in addition supplementary value dimensions were considered. Patients. Metastatic castrate-resistant prostate cancer patients were considered having received prior chemotherapy. Interventions. Abiraterone, cabazitaxel, and enzalutamide were evaluated as third-line treatments. Measurements. Participants’ value preferences were elicited involving criteria selection, options scoring, criteria weighting, and their aggregation. Results. Eight criteria attributes were finally included in the model relating to therapeutic impact, safety profile, socioeconomic impact, and innovation level with relative importance weights 44.5%, 33.3%, 14.8%, and 7.4% per cluster, respectively. Enzalutamide scored the highest overall weighted preference value score, followed by abiraterone and cabazitaxel. Dividing treatments’ overall weighted preference value scores by their costs derived “costs per unit of value” for ranking the treatments based on value-for-money grounds. Limitations. Study limitations included lack of comparative clinical effects across treatments and the small sample of participants. Conclusion. The Advance Value Framework has the prospects of facilitating the evaluation process in HTA and health care decision making; additional research is recommended to address technical challenges and optimize the use of MCDA for policy making.

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