Health Technology Assessment in Surgery

2012 ◽  
Vol 101 (2) ◽  
pp. 132-137 ◽  
Author(s):  
D. Bergqvist ◽  
M. Rosén
Keyword(s):  
Health Technology Assessment ◽  
Randomized Controlled Trials ◽  
Technology Assessment ◽  
Health Technology ◽  
Population Based ◽  
Controlled Trials ◽  
Literature Research ◽  
Randomized Controlled ◽  
Surgical Methods ◽  
Ideal Method

This review focuses on how surgical methods should be assessed from a health technology perspective. The use of randomized controlled trials, population based registries, systematic literature research and the recently published IDEAL method are briefly discussed.

scholarly journals Intravenous compounding robots in pharmacy intravenous admixture services: a health technology assessment

2021 ◽  
Author(s):  
lingli zhang ◽  
chunsong yang ◽  
Lijuan Peng ◽  
Xiaofeng Ni
Keyword(s):  
Health Technology Assessment ◽  
Randomized Controlled Trials ◽  
Technology Assessment ◽  
Production Efficiency ◽  
Health Technology ◽  
Qualitative Description ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Labor Costs ◽  
Randomized Controlled

Abstract Background This study was performed to conduct a health technology assessment of intravenous compounding robots and provide the currently available best evidence for hospital decision-makers. Methods A comprehensive search of relevant professional health technology assessment websites and electronic databases (Embase, PubMed, The Cochrane Library, CNKI, VIP, CBM, and Wanfang Database) was conducted from inception to 11 August 2020. Two reviewers independently screened literature according to the inclusion and exclusion criteria and extracted data. The results were reported by qualitative description because of heterogeneity in the characteristics of the data in the included studies. Results Forty studies were included: 2 health technology assessments, 24 control studies (6 randomized controlled trials, 13 non-randomized contemporaneous controlled trials, and 6 non-randomized historical controlled trials), 12 non-controlled studies (11 single-arm studies, 1 investigation report), 1 qualitative study (in-depth interview), and 1 economics research. Effectiveness: The robots improved the production efficiency compared with usual/manual preparation; however, the intravenous preparation process requires further optimization. Additionally, robots reduced the incidence of medicine residues, preparation errors, and preparation failures. The accuracy and solution properties of intravenous admixture medicines were satisfactory, and the robots also contributed to error recognition. Safety: The robots reduced product pollution and environmental pollution, but vigilance is still required to ensure that pollution stays low. The robots also reduced the incidence of health damage to technicians. Economy: The robots reduced material costs in these studies; however, whether they can reduce labor costs remains unclear. Social suitability: Technicians had a high degree of satisfaction with the robots, but few relevant studies focused on this aspect. Conclusion Intravenous compounding robots have certain advantages in terms of safety, effectiveness, economy, and social adaptability. High-quality and large-sample randomized controlled trials or well-designed observational studies are still needed to evaluate such robots, especially in terms of economic and social suitability.

HEALTH TECHNOLOGY ASSESSMENT AND PERSONALIZED MEDICINE: ARE ECONOMIC EVALUATION GUIDELINES SUFFICIENT TO SUPPORT DECISION MAKING?

2014 ◽  
Vol 30 (2) ◽  
pp. 179-187 ◽  
Author(s):  
Don Husereau ◽  
Deborah A. Marshall ◽  
Adrian R. Levy ◽  
Stuart Peacock ◽  
Jeffrey S. Hoch
Keyword(s):  
Decision Making ◽  
Economic Evaluation ◽  
Personalized Medicine ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Population Based ◽  
New Paradigm ◽  
Current Guidance ◽  
Support Decision Making

Background: Many jurisdictions delivering health care, including Canada, have developed guidance for conducting economic evaluation, often in the service of larger health technology assessment (HTA) and reimbursement processes. Like any health intervention, personalized medical (PM) interventions have costs and consequences that must be considered by reimbursement authorities with limited resources. However, current approaches to economic evaluation to support decision making have been largely developed from population-based approaches to therapy—that is, evaluating the costs and consequences of single interventions across single populations. This raises the issue as to whether these methods, as they are or more refined, are adequate to address more targeted approaches to therapy, or whether a new paradigm for assessing value in PM is required.Objectives: We describe specific issues relevant to the economic evaluation of diagnostics-based PM and assess whether current guidance for economic evaluation is sufficient to support decision making for PM interventions.Methods: Issues were identified through literature review and informal interviews with national and international experts (n = 10) in these analyses. This article elaborates on findings and discussion at a workshop held in Ottawa, Canada, in January 2012.Results: Specific issues related to better guiding economic evaluation of personalized medicine interventions include: how study questions are developed, populations are characterized, comparators are defined, effectiveness is evaluated, outcomes are valued and how resources are measured. Diagnostics-based PM also highlights the need for analyses outside of economic evaluation to support decision making.Conclusions: The consensus of this group of experts is that the economic evaluation of diagnostics-based PM may not require a new paradigm. However, greater complexity means that existing approaches and tools may require improvement to undertake these more analyses.

The Alberta hip and knee replacement project: A model for health technology assessment based on comparative effectiveness of clinical pathways

2009 ◽  
Vol 25 (02) ◽  
pp. 113-123 ◽  
Author(s):  
Katherine L. Gooch ◽  
Douglas Smith ◽  
Tracy Wasylak ◽  
Peter D. Faris ◽  
Deborah A. Marshall ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Knee Replacement ◽  
Study Design ◽  
Technology Assessment ◽  
Comparative Effectiveness ◽  
Clinical Pathways ◽  
Controlled Trial ◽  
Health Technology ◽  
Randomized Controlled

Background:The Alberta Hip and Knee Replacement Project developed a new evidence-based clinical pathway (NCP) for total hip (THR) and knee (TKR) replacement. The aim was to facilitate the delivery of services in a timely and cost-effective manner while achieving the highest quality of care for the patient across the full continuum of care from patient referral to an orthopedic surgeon through surgery, recovery, and rehabilitation. The purpose of this article is to provide an overview of the study design, rationale, and execution of this project as a model for health technology assessment based on comparative effectiveness of alternative clinical pathways.Methods:A pragmatic randomized controlled trial study design was used to evaluate the NCP compared with the standard of care (SOC) for these procedures. The pragmatic study design was selected as a rigorous approach to produce high quality evidence suitable for informing decisions between relevant interventions in real clinical practice. The NCP was evaluated in three of the nine regional health authorities (RHAs) in Alberta with dedicated central intake clinics offering multidisciplinary care teams, constituting 80 percent of THR and TKR surgeries performed annually in Alberta. Patients were identified in the offices of twenty orthopedic surgeons who routinely performed THR or TKR surgeries. Evaluation outcome measures were based on the six dimensions of the Alberta Quality Matrix for Health (AQMH): acceptability, accessibility, appropriateness, effectiveness, efficiency and safety. Data were collected prospectively through patient self-completed questionnaires at baseline and 3 and 12 months after surgery, ambulatory and inpatient chart reviews, and electronic administrative data.Results:The trial design was successful in establishing similar groups for rigorous evaluation. Of the 4,985 patients invited to participate, 69 percent of patients consented. A total of 3,434 patients were randomized: 1,712 to SOC and 1,722 to the NCP. The baseline characteristics of patients in the two study arms, including demographics, comorbidity as measured by CDS and exposure to pain medications, and health-related quality of life, as measured by Western Ontario and McMaster Universities Osteoarthritis Index and Short Form-36, were similar.Conclusions:The Alberta Hip and Knee Replacement Project demonstrates the feasibility and advantages of applying a pragmatic randomized controlled trial to ascertain comparative effectiveness. This is a model for health technology assessment that incorporates how clinical pathways can be effectively evaluated.

scholarly journals Three wound-dressing strategies to reduce surgical site infection after abdominal surgery: the Bluebelle feasibility study and pilot RCT

2019 ◽  
Vol 23 (39) ◽  
pp. 1-166 ◽  
Author(s):  
Barnaby C Reeves ◽  
Leila Rooshenas ◽  
Rhiannon C Macefield ◽  
Mark Woodward ◽  
Nicky J Welton ◽  
...  
Keyword(s):  
Abdominal Surgery ◽  
Surgical Site Infection ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Value Of Information ◽  
Primary Outcome ◽  
Health Technology ◽  
Controlled Trials ◽  
Site Infection ◽  
Pilot Rct

Background Surgical site infection (SSI) affects up to 20% of people with a primary closed wound after surgery. Wound dressings may reduce SSI. Objective To assess the feasibility of a multicentre randomised controlled trial (RCT) to evaluate the effectiveness and cost-effectiveness of dressing types or no dressing to reduce SSI in primary surgical wounds. Design Phase A – semistructured interviews, outcome measure development, practice survey, literature reviews and value-of-information analysis. Phase B – pilot RCT with qualitative research and questionnaire validation. Patients and the public were involved. Setting Usual NHS care. Participants Patients undergoing elective/non-elective abdominal surgery, including caesarean section. Interventions Phase A – none. Phase B – simple dressing, glue-as-a-dressing (tissue adhesive) or ‘no dressing’. Main outcome measures Phase A – pilot RCT design; SSI, patient experience and wound management questionnaires; dressing practices; and value-of-information of a RCT. Phase B – participants screened, proportions consented/randomised; acceptability of interventions; adherence; retention; validity and reliability of SSI measure; and cost drivers. Data sources Phase A – interviews with patients and health-care professionals (HCPs), narrative data from published RCTs and data about dressing practices. Phase B – participants and HCPs in five hospitals. Results Phase A – we interviewed 102 participants. HCPs interpreted ‘dressing’ variably and reported using available products. HCPs suggested practical/clinical reasons for dressing use, acknowledged the weak evidence base and felt that a RCT including a ‘no dressing’ group was acceptable. A survey showed that 68% of 1769 wounds (727 participants) had simple dressings and 27% had glue-as-a-dressing. Dressings were used similarly in elective and non-elective surgery. The SSI questionnaire was developed from a content analysis of existing SSI tools and interviews, yielding 19 domains and 16 items. A main RCT would be valuable to the NHS at a willingness to pay of £20,000 per quality-adjusted life-year. Phase B – from 4 March 2016 to 30 November 2016, we approached 862 patients for the pilot RCT; 81.1% were eligible, 59.4% consented and 394 were randomised (simple, n = 133; glue, n = 129; no dressing, n = 132); non-adherence was 3 out of 133, 8 out of 129 and 20 out of 132, respectively. SSI occurred in 51 out of 281 participants. We interviewed 55 participants. All dressing strategies were acceptable to stakeholders, with no indication that adherence was problematic. Adherence aids and patients’ understanding of their allocated dressing appeared to be key. The SSI questionnaire response rate overall was 67.2%. Items in the SSI questionnaire fitted a single scale, which had good reliability (test–retest and Cronbach’s alpha of > 0.7) and diagnostic accuracy (c-statistic = 0.906). The key cost drivers were hospital appointments, dressings and redressings, use of new medicines and primary care appointments. Limitations Multiple activities, often in parallel, were challenging to co-ordinate. An amendment took 4 months, restricting recruitment to the pilot RCT. Only 67% of participants completed the SSI questionnaire. We could not implement photography in theatres. Conclusions A main RCT of dressing strategies is feasible and would be valuable to the NHS. The SSI questionnaire is sufficiently accurate to be used as the primary outcome. A main trial with three groups (as in the pilot) would be valuable to the NHS, using a primary outcome of SSI at discharge and patient-reported SSI symptoms at 4–8 weeks. Trial registration Phase A – Current Controlled Trials ISRCTN06792113; Phase B – Current Controlled Trials ISRCTN49328913. 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. 39. See the NIHR Journals Library website for further project information. Funding was also provided by the Medical Research Council ConDuCT-II Hub (reference number MR/K025643/1).

OP21 Involving Clinical Experts In Prioritizing Topics For Health Technology Assessment: A Randomized Controlled Trial

2017 ◽  
Vol 33 (S1) ◽  
pp. 9-10
Author(s):  
Andrew Cook ◽  
Elke Streit ◽  
Gill Davage
Keyword(s):  
Randomized Controlled Trial ◽  
Health Services ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Controlled Trial ◽  
Health Technology ◽  
Free Text ◽  
Usual Practice ◽  
Randomized Controlled ◽  
The Difference

INTRODUCTION:The National Institute for Health Research Health Technology Assessment (NIHR HTA) Programme commissions research to inform health services in the United Kingdom. The program prioritises research ideas from literature, guidelines, patients, and clinicians, to decide which research should be funded. We get clinical input on these ideas through (i) committees of clinicians and patients and (ii) seeking written advice from multiple clinicians — a refereeing process. Chairs of our committees suggested that the material we sent to clinicians was too extensive and the method of response too burdensome. We set out to determine whether reducing the information provided or burden of response would improve the engagement of clinicians with our processes, and hence improve the quality of advice provided, and the research available to health services.METHODS:We undertook a factorial randomized controlled trial (University of Southampton Faculty of Medicine Ethics Committee #8192, Trial registration: ACTRN12614000167662). Each participant was randomized to receive one of two types of material to comment on, and one of two means to respond. In the first allocation participants were randomised in a 1:1 ratio between receiving a ‘vignette’ (a briefing paper of up to ten pages discussing possible research = usual practice), or a ‘commissioning brief’ (a single page summarising the proposed research). In the second allocation, the method of response was randomized, between a structured form and free text email.RESULTS:We randomized 460 clinical experts, and 356 (77.4 percent) responded. The responses were graded for quality on a scale of 0 to 4 (higher scores better). Non-response was scored as 0. Analysis using ANOVA gave results of a structured response scoring .34 points (Standard Deviation, SD .36) over a freeform response (p = .02); and the commissioning brief as .04 points over a vignette (p = .81).CONCLUSIONS:This was the first randomized trial to take place inside the secretariat of the HTA program. The difference in quality score between the brief and the vignette allocations was neither statistically nor practically important. The difference between the structured and freeform response was statistically significant, and sufficiently large to be important in practice. While the choice of material to share with clinicians seems unimportant we have shown that it is worth sending a structured response form to experts.

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