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.

Qualitative comparative analysis of health economic evaluation guidelines for health technology assessment in European countries

2020 ◽  
pp. 1-8
Author(s):  
Konstantinos Zisis ◽  
Panagiota Naoum ◽  
Kostas Athanasakis
Keyword(s):  
Sensitivity Analysis ◽  
Content Analysis ◽  
Economic Evaluation ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Evaluation Method ◽  
Outcome Measure ◽  
Health Technology ◽  
European Countries ◽  
Common Practices

Abstract Objective To classify, analyze, and compare published guidelines for economic evaluation within health technology assessment (HTA) in European countries and highlight differences and similarities. Methods We performed a literature review to identify published guidance for the conduct and assessment of economic evaluation studies that are undertaken within the context of HTA processes in European countries. Organizations and working groups were identified via the ISPOR, INAHTA, and EUnetHTA databases. Following the identification of official documents, we performed a qualitative content analysis to highlight discrepancies or common practices under the following categories: comparator, perspective on costs/benefits, time horizon, economic evaluation method, instrument used for utility measurement, outcome measure, source for efficacy, modeling, sensitivity analysis, discounting, and incremental cost-effectiveness ratio. Results A total of nineteen guidance documents were identified (in English) providing data for the analysis in nineteen countries. The comparative content analysis identified common practices in most countries regarding the approaches to the choice of comparator, source of data, the preferred economic evaluation method, the option for a lifetime analytical horizon, discounting, and the choice of key outcome measure—for which, most countries recommend the use of the EQ-5D instrument. Differences were mainly found in the choice of perspective, dealing with uncertainty and sensitivity analysis, the use of end points, and the required use of modeling. Conclusions The use of economic evaluation constitutes one of the key pillars of the HTA process in Europe. Although a methodological convergence has occurred during the last few years, notable differences still remain.

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.

scholarly journals Stepped approach to improving sexual function after gynaecological cancer: the SAFFRON feasibility RCT

2019 ◽  
Vol 23 (6) ◽  
pp. 1-92
Author(s):  
Sue Gessler ◽  
Michael King ◽  
Alessandra Lemma ◽  
Julie Barber ◽  
Louise Jones ◽  
...  
Keyword(s):  
Sexual Function ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Clinical Skills ◽  
Pilot Trial ◽  
Health Technology ◽  
Gynaecological Cancer ◽  
Stepped Care ◽  
Treatment Level ◽  
Psychosocial Studies

Background Women affected by gynaecological cancer are often unaware of the sexual consequences of both the cancer and its treatment. Most do not receive appropriate advice or help to recover sexual function, and the effect on their sexuality may be profound, both physically and emotionally. However, several potential therapies can be effective in helping recover some sexual engagement and change self-perception around sex. A major initial challenge is informing and involving patients in an appropriate and sensitive manner, and a further issue is delivering therapies in busy gynaelogical oncology clinics. This study was conceived in response to a National Institute for Health Research (NIHR) Health Technology Assessment (HTA) call asking for proposals to improve sexual functioning in women treated for gynaecological cancer while taking into account associated issues of mood. Existing evidence-based therapies for improving sexual function after cancer treatment were adapted and placed within a ‘stepped care’ model for delivering these in the NHS setting. An assessment and treatment stepping algorithm was developed in parallel, both to assign women to a treatment level at assessment and to follow their progress session by session to advise on changing intervention level. The assessment tool was applied to all participants on the principle that the problem was sexual difficulty, not the cancer of origin. Participants Women aged > 18 years (with partners at their choice) treated for any gynaecological malignancy with surgery and/or chemotherapy and/or radiation at University College London Hospital or Bristol Gynaecological cancer centres, minimally 3 months post end of treatment, of any sexual orientation, with sexual function difficulties identified by three initial screening questions. Design A feasibility two-arm, parallel-group randomised controlled pilot trial. Setting Two NHS gynaecological cancer centres, one in London and one in Bristol. Interventions A three-level stepped care intervention. Objective To assess the feasibility of conducting a full-scale investigation of stepped therapy and indicate the potential benefits to patients and to the NHS generally. Primary outcome measures Recruitment to study, proportion of women stepping up, number of usable data points of all measures and time points over length of trial, and retention of participants to end of trial. Results Development of the intervention and accompanying algorithm was completed. The study was stopped before the recruitment stage and, hence, no randomisation, recruitment, numbers analysed, outcomes or harms were recorded. Limitations As the study did not proceed, the intervention and its accompanying algorithm have not been evaluated in practice, and the capacity of the NHS system to deliver it has not been examined. Conclusions None, as the study was halted. Future work The intervention could be studied within a clinical setting; however, the experience of the study group points to the need for psychosocial studies in medical settings to establish pragmatic and innovative mechanisms to ensure adequate resource when extending staff clinical skills and time to deliver any new intervention for the duration of the trial. Trial registration Current Controlled Trials ISRCTN12010952 and ClinicalTrials.gov NCT02458001. Funding This project was funded by the NIHR HTA programme and will be published in full in Health Technology Assessment; Vol. 23, No. 5. See the NIHR Journals Library website for further project information.

scholarly journals Comparative health technology assessment of robotic-assisted, direct manual laparoscopic and open surgery: a prospective study

2016 ◽  
Vol 31 (2) ◽  
pp. 543-551 ◽  
Author(s):  
Giuseppe Turchetti ◽  
Francesca Pierotti ◽  
Ilaria Palla ◽  
Stefania Manetti ◽  
Cinzia Freschi ◽  
...  
Keyword(s):  
Prospective Study ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Open Surgery ◽  
Health Technology ◽  
Robotic Assisted ◽  
A Prospective Study

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 Pressure garment to prevent abnormal scarring after burn injury in adults and children: the PEGASUS feasibility RCT and mixed-methods study

2018 ◽  
Vol 22 (36) ◽  
pp. 1-162 ◽  
Author(s):  
Naiem Moiemen ◽  
Jonathan Mathers ◽  
Laura Jones ◽  
Jonathan Bishop ◽  
Philip Kinghorn ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Standard Care ◽  
Pilot Trial ◽  
Health Technology ◽  
Burn Scar ◽  
Individual Interviews ◽  
Scar Management

Background Eleven million people suffer a fire-related injury worldwide every year, and 71% have significant scarring. Pressure garment therapy (PGT) is a standard part of burn scar management, but there is little evidence of its clinical effectiveness or cost-effectiveness. Objective To identify the barriers to, and the facilitators of, conducting a randomised controlled trial (RCT) of burn scar management with and without PGT and test whether or not such a trial is feasible. Design Web-based surveys, semistructured individual interviews, a pilot RCT including a health economic evaluation and embedded process evaluation. Setting UK NHS burns services. Interviews and the pilot trial were run in seven burns services. Participants Thirty NHS burns services and 245 staff provided survey responses and 15 staff participated in individual interviews. Face-to-face interviews were held with 24 adult patients and 16 parents of paediatric patients who had undergone PGT. The pilot trial recruited 88 participants (57 adults and 31 children) who were at risk of hypertrophic scarring and were considered suitable for scar management therapy. Interviews were held with 34 participants soon after recruitment, with 23 participants at 12 months and with eight staff from six sites at the end of the trial. Interventions The intervention was standard care with pressure garments. The control was standard care comprising scar management techniques involving demonstration and recommendations to undertake massage three or four times per day with moisturiser, silicone treatment, stretching and other exercises. Main outcome measures Feasibility was assessed by eligibility rates, consent rates, retention in allocated arms, adherence with treatment and follow-up and completion of outcome assessments. The outcomes from interview-based studies were core outcome domains and barriers to, and facilitators of, trial participation and delivery. Results NHS burns services treat 2845 patients per annum (1476 paediatric and 1369 adult) and use pressure garments for 6–18 months, costing £2,171,184. The majority of staff perceived a need for a RCT of PGT, but often lacked equipoise around the research question and PGT as a treatment. Strong views about the use of PGT have the potential to influence the conduct of a full-scale RCT. A range of outcome domains was identified as important via the qualitative research: perceptions of appearance, specific scar characteristics, function, pain and itch, broader psychosocial outcomes and treatment burden. The outcome tools evaluated in the pilot trial did not cover all of these domains. The planned 88 participants were recruited: the eligibility rate was 88% [95% confidence interval (CI) 83% to 92%], the consent rate was 47% (95% CI 40% to 55%). Five (6%) participants withdrew, 14 (16%) were lost to follow-up and 8 (9%) crossed over. Adherence was as in clinical practice. Completion of outcomes was high for adult patients but poorer from parents of paediatric patients, particularly for quality of life. Sections on range of movement and willingness to pay were found to be challenging and poorly completed. Limitations The Brisbane Burn Scar Impact Profile appears more suitable in terms of conceptual coverage than the outcome scales that were used in the trial but was not available at the time of the study. Conclusions A definitive RCT of PGT in burn scar management appears feasible. However, staff attitudes to the use of pressure garments may lead to biases, and the provision of training and support to sites and an ongoing assessment of trial processes are required. Future work We recommend that any future trial include an in-depth mixed-methods recruitment investigation and a process evaluation to account for this. Trial registration Current Controlled Trials ISRCTN34483199. 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. 22, No. 36. See the NIHR Journals Library website for further project information

scholarly journals Retrograde intramedullary nail fixation compared with fixed-angle plate fixation for fracture of the distal femur: the TrAFFix feasibility RCT

2019 ◽  
Vol 23 (51) ◽  
pp. 1-132 ◽  
Author(s):  
Xavier L Griffin ◽  
Matthew L Costa ◽  
Emma Phelps ◽  
Nicholas Parsons ◽  
Melina Dritsaki ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Process Evaluation ◽  
Technology Assessment ◽  
Distal Femur ◽  
Locking Plate ◽  
Plate Fixation ◽  
Health Technology ◽  
Recruitment Rate ◽  
Definitive Trial ◽  
Retrograde Nail

Background Fractures of the distal femur are an increasingly common injury; the optimal management of these injuries remains controversial. The two interventions used in UK practice are intramedullary fixation, with a locked retrograde nail, and extramedullary fixation, with a fixed angle plate. Objectives This study assessed the feasibility of a definitive trial and included a process evaluation to understand the generalisability and likely success of a future trial. Design A multicentre, parallel, two-arm, randomised controlled feasibility trial with an embedded process evaluation. Treatment with a plate or nail was allocated in a 1 : 1 ratio, stratified by centre and chronic cognitive impairment. Surgeons were not blinded, but participants were not told their allocation. Setting Seven NHS hospitals. Participants Patients aged ≥ 18 years with a fracture of the distal femur who the attending surgeon believed would benefit from internal fixation were potentially eligible. Patients were excluded if they had a loose arthroplasty requiring revision or a femoral deformity or arthroplasty that precluded nail fixation. The sample was recruited between 29 September 2016 and 31 August 2017. Consent was obtained from the patient or appropriate consultee before enrolment. Interventions Patients were randomised to receive fixation of their distal femur fracture with either a proximally and distally locked retrograde nail that spanned the diaphysis of the femur or an anatomical distal femoral locking plate with at least one locked screw distal to the fracture. Reduction and supplemental fixation were at the surgeon’s discretion. Outcomes The primary outcome measures for this study were the recruitment rate and the completion rate of the EuroQol-5 Dimensions, five-level version (EQ-5D-5L), at 6 weeks and 4 months. Additional measurements included baseline characteristics, measures of social support and self-efficacy, disability rating index, dementia quality-of-life measures and a radiographical assessment of any malunion. Participants’ and staff views were obtained, at interview, for the process evaluation. Results The process evaluation showed that surgeon-related factors, principally confidence with both technologies and a lack of individual equipoise, were key barriers to recruitment. A total of 23 participants were randomised and analysed (nail, n = 11; plate, n = 12). The recruitment rate was estimated as 0.42 [95% confidence interval (CI) 0.27 to 0.62] participants per centre per month, lower than the prespecified feasibility threshold of 1.0 participants per centre per month. Data completeness of the EQ-5D-5L was estimated at 65% (95% CI 43% to 83%). Conclusions This feasibility study has challenged many of the assumptions that underpinned the development of proposed definitive trial protocol. A modified protocol is proposed that would be feasible given the recruitment rate observed here, which is equal to that reported in the similar FixDT trial [Health Technology Assessment (HTA) 11/136/04: Costa ML, Achten J, Hennings S, Boota N, Griffin J, Petrou S, et al. Intramedullary nail fixation versus locking plate fixation for adults with a fracture of the distal tibia: the UK FixDT RCT. Health Technol Assess 2018;22(25)], which delivered to target and budget. Future work A definitive trial with a modified design is recommended, including an internal pilot to confirm initial recruitment rate assumptions. Registration Current Controlled Trials ISRCTN92089567. 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. 23, No. 51. See the NIHR Journals Library website for further project information. Funding was also supported by the NIHR Oxford Biomedical Research Centre.

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.

Usefulness of a short-term register for health technology assessment where the evidence base is poor

2010 ◽  
Vol 26 (1) ◽  
pp. 95-101 ◽  
Author(s):  
Hannah Patrick ◽  
Sally Gallaugher ◽  
Carolyn Czoski-Murray ◽  
Robert Wheeler ◽  
Marc Chattle ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Pectus Excavatum ◽  
Patient Reported Outcomes ◽  
Interventional Procedure ◽  
Health Technology ◽  
Assessment Process ◽  
Nuss Procedure ◽  
Short Term ◽  
Patient Reported

Objectives: This study reviews the coverage and usefulness of a short-term register, established specifically for health technology assessment of a novel interventional procedure (minimally invasive repair of pectus excavatum, or the Nuss procedure).Methods: Coverage of the register during 2004–07 was assessed by comparison with Hospital Episodes Statistics (HES) for England. Its usefulness was assessed by comparing safety and efficacy data with the published literature and by feedback from committee members who in 2009 were involved in reviewing NICE's original guidance from 2003.Results: The register reported 260 cases from thirteen UK hospitals during nearly 9 years. During a coverage evaluation period of 3 years, there were 152 registered Nuss procedures. An additional 246 repairs of pectus excavatum were undertaken in twenty-six previously unidentified hospitals. Of the 246, 23 were Nuss procedures (from two hospitals), 140 were open procedures (from eleven hospitals), and 3 were coding errors. No details were available for eighty cases undertaken at ten hospitals. The quantity of published literature had increased substantially since publication of original guidance in 2003. It related mostly to technical and safety outcomes, whereas the register included patient reported outcomes. The literature and the register reported similar rates of major adverse events such as bar displacement (2–10 percent). Committee members considered that the Register made a useful contribution to guidance development.Conclusions: This study shows that a register set up to support a health technology assessment process can produce useful data both about safety and about patient-reported outcomes. Coverage may be improved by active follow-up based on routine hospital statistics. Improvement in coding for new procedures is needed in the United Kingdom.

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