Oral versus intravenous antibiotics for bone and joint infections: the OVIVA non-inferiority RCT

Background Management of bone and joint infection commonly includes 4–6 weeks of intravenous (IV) antibiotics, but there is little evidence to suggest that oral (PO) therapy results in worse outcomes. Objective To determine whether or not PO antibiotics are non-inferior to IV antibiotics in treating bone and joint infection. Design Parallel-group, randomised (1 : 1), open-label, non-inferiority trial. The non-inferiority margin was 7.5%. Setting Twenty-six NHS hospitals. Participants Adults with a clinical diagnosis of bone, joint or orthopaedic metalware-associated infection who would ordinarily receive at least 6 weeks of antibiotics, and who had received ≤ 7 days of IV therapy from definitive surgery (or start of planned curative treatment in patients managed non-operatively). Interventions Participants were centrally computer-randomised to PO or IV antibiotics to complete the first 6 weeks of therapy. Follow-on PO therapy was permitted in either arm. Main outcome measure The primary outcome was the proportion of participants experiencing treatment failure within 1 year. An associated cost-effectiveness evaluation assessed health resource use and quality-of-life data. Results Out of 1054 participants (527 in each arm), end-point data were available for 1015 (96.30%) participants. Treatment failure was identified in 141 out of 1015 (13.89%) participants: 74 out of 506 (14.62%) and 67 out of 509 (13.16%) of those participants randomised to IV and PO therapy, respectively. In the intention-to-treat analysis, using multiple imputation to include all participants, the imputed risk difference between PO and IV therapy for definitive treatment failure was –1.38% (90% confidence interval –4.94% to 2.19%), thus meeting the non-inferiority criterion. A complete-case analysis, a per-protocol analysis and sensitivity analyses for missing data each confirmed this result. With the exception of IV catheter complications [49/523 (9.37%) in the IV arm vs. 5/523 (0.96%) in the PO arm)], there was no significant difference between the two arms in the incidence of serious adverse events. PO therapy was highly cost-effective, yielding a saving of £2740 per patient without any significant difference in quality-adjusted life-years between the two arms of the trial. Limitations The OVIVA (Oral Versus IntraVenous Antibiotics) trial was an open-label trial, but bias was limited by assessing all potential end points by a blinded adjudication committee. The population was heterogenous, which facilitated generalisability but limited the statistical power of subgroup analyses. Participants were only followed up for 1 year so differences in late recurrence cannot be excluded. Conclusions PO antibiotic therapy is non-inferior to IV therapy when used during the first 6 weeks in the treatment for bone and joint infection, as assessed by definitive treatment failure within 1 year of randomisation. These findings challenge the current standard of care and provide an opportunity to realise significant benefits for patients, antimicrobial stewardship and the health economy. Future work Further work is required to define the optimal total duration of therapy for bone and joint infection in the context of specific surgical interventions. Currently, wide variation in clinical practice suggests significant redundancy that likely contributes to the excess and unnecessary use of antibiotics. Trial registration Current Controlled Trials ISRCTN91566927. 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. 38. See the NIHR Journals Library website for further project information.

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COMPARISON OF RECENTLY USED PHACOEMULSIFICATION SYSTEMS USING A HEALTH TECHNOLOGY ASSESSMENT METHOD

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462317000472 ◽

2017 ◽

Vol 33 (2) ◽

pp. 232-238

Author(s):

Jiannan Huang ◽

Qi Wang ◽

Caimin Zhao ◽

Xiaohua Ying ◽

Haidong Zou

Keyword(s):

Health Technology Assessment ◽

Technology Assessment ◽

Vision System ◽

Health Technology ◽

Assessment Method ◽

Dissipated Energy ◽

Positive Trend ◽

Significant Difference ◽

Tertiary Hospitals ◽

Cataract Patients

Objectives: To compare the recently used phacoemulsification systems using a health technology assessment (HTA) model.Methods: A self-administered questionnaire, which included questions to gauge on the opinions of the recently used phacoemulsification systems, was distributed to the chief cataract surgeons in the departments of ophthalmology of eighteen tertiary hospitals in Shanghai, China. A series of senile cataract patients undergoing phacoemulsification surgery were enrolled in the study. The surgical results and the average costs related to their surgeries were all recorded and compared for the recently used phacoemulsification systems.Results: The four phacoemulsification systems currently used in Shanghai are the Infiniti Vision, Centurion Vision, WhiteStar Signature, and Stellaris Vision Enhancement systems. All of the doctors confirmed that the systems they used would help cataract patients recover vision. A total of 150 cataract patients who underwent phacoemulsification surgery were enrolled in the present study. A significant difference was found among the four groups in cumulative dissipated energy, with the lowest value found in the Centurion group. No serious complications were observed and a positive trend in visual acuity was found in all four groups after cataract surgery. The highest total cost of surgery was associated with procedures conducted using the Centurion Vision system, and significant differences between systems were mainly because of the cost of the consumables used in the different surgeries.Conclusions: This HTA comparison of four recently used phacoemulsification systems found that each of system offers a satisfactory vision recovery outcome, but differs in surgical efficacy and costs.

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QUALITY OF HEALTH TECHNOLOGY ASSESSMENT REPORTS PREPARED FOR THE MEDICAL SERVICES ADVISORY COMMITTEE

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462316000477 ◽

2016 ◽

Vol 32 (4) ◽

pp. 315-323 ◽

Cited By ~ 1

Author(s):

Martin Hua ◽

Tristan Boonstra ◽

Patrick J. Kelly ◽

Andrew Wilson ◽

Jonathan C. Craig ◽

...

Keyword(s):

Health Technology Assessment ◽

Advisory Committee ◽

Technology Assessment ◽

Health Technology ◽

Medical Services ◽

Health Technologies ◽

European Collaboration ◽

Significant Difference ◽

Over Time

Objectives:The Medical Services Advisory Committee (MSAC) makes recommendations to the Australian Government for funding health technologies under the Medicare Benefits Schedule (MBS). Differences in public, clinical, commercial, and political opinions on health expenditure emphasize the importance of defensible funding decisions. We aimed to evaluate the quality of health technology assessment (HTA) reports over time and among health technologies assessed for MSAC.Main Outcome Measures:A cohort study was performed of HTA reports prepared for MSAC between 1998 and 2013. We measured the quality of HTA reports using reporting guidelines proposed by the European Collaboration for Assessment of Health Interventions. Individual component scores across eleven domains were calculated, and summed for an overall aggregate score. We used linear regression to investigate any change in quality over time and among the types of technologies assessed.Results:We included 110 HTA reports. The safety (80 percent), effectiveness (84 percent), economic (74 percent), and organizational (99 percent) domains were better reported than the psychological, social, and ethical considerations (34 percent). The basic (75 percent), methodological (62 percent), background (82 percent), contextual (46 percent), status quo (54 percent), and technical information (66 percent) that framed each assessment were inconsistently reported. On average, overall quality scores increased by 2 percent (p< 0.001) per year, from approximately 60 percent to 80 percent over the 15-year period, with no significant difference among surgical, diagnostic or other nonpharmaceutical health technologies (p= 0.22).Conclusions:HTA reports prepared for MSAC are a key tool in allocating scarce health resources. The overall quality of these reports has improved, but the reporting of specific domains and subthemes therein could be better addressed.

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Adding emollient bath additives to standard eczema management for children with eczema: the BATHE RCT

Health Technology Assessment ◽

10.3310/hta22570 ◽

2018 ◽

Vol 22 (57) ◽

pp. 1-116 ◽

Cited By ~ 3

Author(s):

Miriam Santer ◽

Kate Rumsby ◽

Matthew J Ridd ◽

Nick A Francis ◽

Beth Stuart ◽

...

Keyword(s):

Health Technology Assessment ◽

Technology Assessment ◽

Primary Outcome ◽

Intervention Group ◽

Additive Group ◽

Health Technology ◽

Control Group ◽

Open Label ◽

Secondary Outcomes ◽

Bath Additives

BackgroundChildhood eczema is very common. Treatment often includes emollient bath additives, despite there being little evidence of their effectiveness.ObjectivesTo determine the clinical effectiveness and cost-effectiveness of emollient bath additives in the management of childhood eczema.DesignPragmatic, randomised, open-label, multicentre superiority trial with two parallel groups.SettingNinety-six general practices in Wales, the west of England and southern England. Invitation by personal letter or opportunistically.ParticipantsChildren aged between 12 months and 12 years fulfilling the UK Diagnostic Criteria for Atopic Eczema. Children with inactive or very mild eczema (a score of ≤ 5 on the Nottingham Eczema Severity Scale) were excluded, as were children who bathed less than once per week or whose parents/carers were not prepared to accept randomisation.InterventionsThe intervention group were prescribed bath additives by their usual clinical team and were asked to use them regularly for 12 months. The control group were asked to use no bath additives for 12 months. Both groups continued standard eczema management, including regular leave-on emollients and topical corticosteroids (TCSs) when required.Main outcome measuresThe primary outcome was eczema control measured by Patient Oriented Eczema Measure [POEM, 0 (clear) to 28 (severe)] weekly for 16 weeks. The secondary outcomes were eczema severity over 1 year (4-weekly POEM), number of eczema exacerbations, disease-specific quality of life (QoL) (Dermatitis Family Impact Questionnaire), generic QoL (Child Health Utility-9 Dimensions) and type and quantity of topical steroid/calcineurin inhibitors prescribed. Children were randomised (1 : 1) using online software to either bath additives plus standard eczema care or standard eczema care alone, stratified by recruiting centre, and there was open-label blinding.ResultsFrom December 2014 to May 2016, 482 children were randomised: 51% were female, 84% were white and the mean age was 5 years (n = 264 in the intervention group,n = 218 in the control group). Reported adherence to randomised treatment allocation was > 92% in both groups, with 76.7% of participants completing at least 12 (80%) of the first 16 weekly questionnaires for the primary outcome. Baseline POEM score was 9.5 [standard deviation (SD) 5.7] in the bath additives group and 10.1 (SD 5.8) in the no bath additives group. Average POEM score over the first 16 weeks was 7.5 (SD 6.0) in the bath additives group and 8.4 (SD 6.0) in the no bath additives group, with no statistically significant difference between the groups. After controlling for baseline severity and confounders (ethnicity, TCS use, soap substitute use) and allowing for clustering of participants within centres and responses within participants over time, POEM scores in the no bath additive group were 0.41 points higher than in the bath additive group (95% confidence interval –0.27 to 1.10), which is well below the published minimal clinically important difference of 3 points. There was no difference between groups in secondary outcomes or in adverse effects such as redness, stinging or slipping.LimitationsSimple randomisation resulted in an imbalance in baseline group size, although baseline characteristics were well balanced between groups.ConclusionThis trial found no evidence of clinical benefit of including emollient bath additives in the standard management of childhood eczema.Future workFurther research is required on optimal regimens of leave-on emollients and the use of emollients as soap substitutes.Trial registrationCurrent Controlled Trials ISRCTN84102309.FundingThis project was funded by the NIHR Health Technology Assessment Programme and will be published in full inHealth Technology Assessment; Vol. 22, No. 57. See the NIHR Journals Library website for further project information.

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Comparing Two Approaches for Thyroidectomy: A Health Technology Assessment through DMAIC Cycle

Healthcare ◽

10.3390/healthcare10010124 ◽

2022 ◽

Vol 10 (1) ◽

pp. 124

Author(s):

Carlo Ricciardi ◽

Adelmo Gubitosi ◽

Donatella Vecchione ◽

Giuseppe Cesarelli ◽

Francesco De Nola ◽

...

Keyword(s):

Health Technology Assessment ◽

Total Thyroidectomy ◽

Technology Assessment ◽

Statistical Tests ◽

Length Of Hospital Stay ◽

Health Technology ◽

Endocrine Surgery ◽

Surgical Approaches ◽

New Device ◽

Significant Difference

Total thyroidectomy is very common in endocrine surgery and the haemostasis can be obtained in different ways across surgery; recently, some devices have been developed to support this surgical phase. In this paper, a health technology assessment is conducted through the define, measure, analyse, improve, and control cycle of the Six Sigma methodology to compare traditional total thyroidectomy with the surgical operation performed through a new device in an overall population of 104 patients. Length of hospital stay, drain output, and time for surgery were considered the critical to qualities in order to compare the surgical approaches which can be considered equal regarding the organizational, ethical, and security impact. Statistical tests (Kolmogorov–Smirnov, t test, ANOVA, Mann–Whitney, and Kruskal–Wallis tests) and visual management diagrams were employed to compare the approaches, but no statistically significant difference was found between them. Considering these results, this study shows that the introduction of the device to perform total thyroidectomy does not guarantee appreciable clinical advantages. A cost analysis to quantify the economic impact of the device into the practice could be a future development. Healthy policy leaders and clinicians who are requested to make decisions regarding the supply of biomedical technologies could benefit from this research.

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OP139 Not Using Data From ‘Failed’ Primary Research Undermines Health Technology Assessment Reporting

International Journal of Technology Assessment in Health Care ◽

10.1017/s026646231800154x ◽

2018 ◽

Vol 34 (S1) ◽

pp. 51-51

Author(s):

Andrew Cook

Keyword(s):

Health Technology Assessment ◽

Technology Assessment ◽

Meta Analysis ◽

Health Technology ◽

Outcome Data ◽

Developmental Dysplasia ◽

Primary Research ◽

Open Label ◽

Quantitative Evidence ◽

Using Data

Introduction:The reliability of health technology assessment (HTA) is built on accessing evidence systematically to inform conclusions and recommendations; however, the availability of primary evidence is a source of bias which can undermine an HTA. This omission is often because attempts to generate primary evidence have not been completely successful. Where partial evidence exists, ignoring it constitutes avoidable bias. Taking the Hip Op trial as an example (a study of developmental dysplasia of the hip (DDH)) we consider how despite lack of quantitative outcomes data, rich information was obtained that should inform HTA in this area.Methods:The Hip Op trial was an open label trial comparing early against late surgery in the management of DDH. In parallel, a qualitative study attempted to explore the experience of parents of children with DDH.Results:The trial protocol called for recruitment of 636 children, but due to changes in clinician equipoise and service configuration only 29 could be recruited. The trial was stopped early. While baseline data for the 29 children was available, no estimate of effect was attempted due to a lack of outcome data; however, the qualitative data was rich, representing the biggest qualitative sample worldwide on this topic. It reflected the patient experience, and shows a clear preference towards early intervention, despite the absence of quantitative evidence.Conclusions:The qualitative work here gives a clear indication that parents have a strong preference. This is data which would not be captured in traditional HTA reports, which tend to focus on quantitative data and meta-analysis. This is, however, information that is important to patients, and should inform clinicians and payers. We discuss how HTA do-ers should make efforts to find this data from ‘failed’ primary research and incorporate it into their reports, and how HTA do-ers could be alert to this situation.

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Adalimumab in combination with methotrexate for refractory uveitis associated with juvenile idiopathic arthritis: a RCT

Health Technology Assessment ◽

10.3310/hta23150 ◽

2019 ◽

Vol 23 (15) ◽

pp. 1-140 ◽

Cited By ~ 3

Author(s):

Athimalaipet V Ramanan ◽

Andrew D Dick ◽

Ashley P Jones ◽

Dyfrig A Hughes ◽

Andrew McKay ◽

...

Keyword(s):

Body Weight ◽

Juvenile Idiopathic Arthritis ◽

Cost Effectiveness ◽

Treatment Failure ◽

Health Technology Assessment ◽

Technology Assessment ◽

Subcutaneous Injection ◽

Tertiary Care ◽

Health Technology ◽

Double Blind

Background Children with juvenile idiopathic arthritis (JIA) are at risk of uveitis. The role of adalimumab (Humira®; AbbVie Inc., Ludwigshafen, Germany) in the management of uveitis in children needs to be determined. Objective To compare the efficacy, safety and cost-effectiveness of adalimumab in combination with methotrexate (MTX) versus placebo with MTX alone, with regard to controlling disease activity in refractory uveitis associated with JIA. Design This was a randomised (applying a ratio of 2 : 1 in favour of adalimumab), double-blind, placebo-controlled, multicentre parallel-group trial with an integrated economic evaluation. A central web-based system used computer-generated tables to allocate treatments. A cost–utility analysis based on visual acuity was conducted and a 10-year extrapolation by Markov modelling was also carried out. Setting The setting was tertiary care centres throughout the UK. Participants Patients aged 2–18 years inclusive, with persistently active JIA-associated uveitis (despite optimised MTX treatment for at least 12 weeks). Interventions All participants received a stable dose of MTX and either adalimumab (20 mg/0.8 ml for patients weighing < 30 kg or 40 mg/0.8 ml for patients weighing ≥ 30 kg by subcutaneous injection every 2 weeks based on body weight) or a placebo (0.8 ml as appropriate according to body weight by subcutaneous injection every 2 weeks) for up to 18 months. A follow-up appointment was arranged at 6 months. Main outcome measures Primary outcome – time to treatment failure [multicomponent score as defined by set criteria based on the Standardisation of Uveitis Nomenclature (SUN) criteria]. Economic outcome – incremental cost per quality-adjusted life-year (QALY) gained from the perspective of the NHS in England and Personal Social Services providers. Full details of secondary outcomes are provided in the study protocol. Results A total of 90 participants were randomised (adalimumab, n = 60; placebo, n = 30). There were 14 (23%) treatment failures in the adalimumab group and 17 (57%) in the placebo group. The analysis of the data from the double-blind phase of the trial showed that the hazard risk (HR) of treatment failure was significantly reduced, by 75%, for participants in the adalimumab group (HR 0.25, 95% confidence interval 0.12 to 0.51; p < 0.0001 from log-rank test). The cost-effectiveness of adalimumab plus MTX was £129,025 per QALY gained. Adalimumab-treated participants had a much higher incidence of adverse and serious adverse events. Conclusions Adalimumab in combination with MTX is safe and effective in the management of JIA-associated uveitis. However, the likelihood of cost-effectiveness is < 1% at the £30,000-per-QALY threshold. Future work A clinical trial is required to define the most effective time to stop therapy. Prognostic biomarkers of early and complete response should also be identified. Trial registration Current Controlled Trials ISRCTN10065623 and European Clinical Trials Database number 2010-021141-41. 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. 15. See the NIHR Journals Library website for further project information. This trial was also funded by Arthritis Research UK (grant reference number 19612). Two strengths of adalimumab (20 mg/0.8 ml and 40 mg/0.8 ml) and a matching placebo were manufactured by AbbVie Inc. (the Marketing Authorisation holder) and supplied in bulk to the contracted distributor (Sharp Clinical Services, Crickhowell, UK) for distribution to trial centres.

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Versorgungsforschung in der Klinischen Neuropsychologie – eine Standortbestimmung

Zeitschrift für Neuropsychologie ◽

10.1024/1016-264x.19.4.253 ◽

2008 ◽

Vol 19 (4) ◽

pp. 253-269 ◽

Cited By ~ 3

Author(s):

Sabine Heel ◽

Sonja Fischer ◽

Stefan Fischer ◽

Tobias Grässer ◽

Ellen Hämmerling ◽

...

Keyword(s):

Health Technology Assessment ◽

Technology Assessment ◽

Health Technology ◽

Empirische Forschung

Zunächst führt dieser Artikel in die wesentlichen Begrifflichkeiten und Zielstellungen der Versorgungsforschung ein. Er befasst sich dann mit der Frage, wie die einzelnen Teildisziplinen der Versorgungsforschung, (1) die Bedarfsforschung, (2) die Inanspruchnahmeforschung, (3) die Organisationsforschung, (4) das Health Technology Assessment, (5) die Versorgungsökonomie, (6) die Qualitätsforschung und zuletzt (7) die Versorgungsepidemiologie konzeptionell zu fassen sind, und wie sie für neuropsychologische Anliegen ausformuliert werden müssen. In diesem Zusammenhang werden die in den einzelnen Bereichen jeweils vorliegenden versorgungsrelevanten Studienergebnisse referiert. Soweit es zulässig ist, werden Bedarfe für die Versorgungsforschung und Versorgungspraxis in der Neurorehabilitation daraus abgeleitet und Anregungen für die weitere empirische Forschung formuliert. Der Artikel bezieht sich – entsprechend seines Anliegens – ausschließlich auf Studien, die sich mit der Situation der deutschen Neurorehabilitation befassen.

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