Systematic review of the limited evidence base for treatments of Eustachian tube dysfunction: a health technology assessment

Objectives:Integration of ethics into health technology assessment (HTA) remains challenging for HTA practitioners. We conducted a systematic review on social and methodological issues related to ethical analysis in HTA. We examined: (1) reasons for integrating ethics (social needs); (2) obstacles to ethical integration; (3) concepts and processes deployed in ethical evaluation (more specifically value judgments) and critical analyses of formal experimentations of ethical evaluation in HTA.Methods:Search criteria included “ethic,” “technology assessment,” and “HTA”. The literature search was done in Medline/Ovid, SCOPUS, CINAHL, PsycINFO, and the international HTA Database. Screening of citations, full-text screening, and data extraction were performed by two subgroups of two independent reviewers. Data extracted from articles were grouped into categories using a general inductive method.Results:A list of 1,646 citations remained after the removal of duplicates. Of these, 132 were fully reviewed, yielding 67 eligible articles for analysis. The social need most often reported was to inform policy decision making. The absence of shared standard models for ethical analysis was the obstacle to integration most often mentioned. Fairness and Equity and values embedded in Principlism were the values most often mentioned in relation to ethical evaluation.Conclusions:Compared with the scientific experimental paradigm, there are no settled proceedings for ethics in HTA nor consensus on the role of ethical theory and ethical expertise hindering its integration. Our findings enable us to hypothesize that there exists interdependence between the three issues studied in this work and that value judgments could be their linking concept.

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Eustachian Tube Balloon Dilation: A Systematic Review and Meta-analysis of Treatment Outcomes

Otolaryngology ◽

10.1177/0194599820924322 ◽

2020 ◽

Vol 163 (5) ◽

pp. 870-882

Author(s):

Michael H. Froehlich ◽

Phong T. Le ◽

Shaun A. Nguyen ◽

Theodore R. McRackan ◽

Habib G. Rizk ◽

...

Keyword(s):

Systematic Review ◽

Eustachian Tube ◽

Valsalva Maneuver ◽

Meta Analysis ◽

Balloon Dilation ◽

Eustachian Tube Dysfunction ◽

Significant Difference ◽

Tube Dysfunction ◽

Outcome Metrics

Objective To examine the effectiveness of eustachian tube balloon dilation for the treatment of eustachian tube dysfunction. Data Sources PubMed, Scopus, and Google Scholar. Review Methods A systematic review of eustachian tube balloon dilation for the treatment of eustachian tube dysfunction was conducted following Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines to identify randomized control trials and prospective and retrospective studies published prior to January 31, 2019. Meta-analysis of proportions evaluated 7-item Eustachian Tube Dysfunction Questionnaire (ETDQ7) scores, tympanometry, otoscopy findings, and the ability to perform a Valsalva maneuver. Results The systematic review identified 35 studies. Twelve studies met inclusion for meta-analysis (448 patients). Mean ETDQ7 scores decreased by 2.13 from baseline to 6 weeks (95% CI, –3.02 to −1.24; P < .001). From baseline to 6 weeks, 53.0% of patients had improvement in tympanograms ( P < .001). At the long-term point (3-12 months), 50.5% of patients had improved tympanograms from baseline ( P < .001). There was no significant difference in the proportion of improved tympanograms at 6 weeks compared to long term ( P = .535). Normal otoscopy exams at baseline increased by 30.0% at 6 weeks ( P < .001) and 55.4% in the long term ( P < .001). There was a 67.8% increase in proportion of patients able to perform a Valsalva maneuver in the long term compared to baseline ( P < .001). Conclusion Eustachian tube balloon dilation appears to be associated with improvement in subjective and objective treatment outcome metrics. The improvement appears stable at 3 to 12 months after dilation. Patients with eustachian tube dysfunction are likely to benefit from balloon dilation, particularly those with medication-refractory disease.

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Pharmacological treatment of oro-facial pain - health technology assessment including a systematic review with network meta-analysis

Journal of Oral Rehabilitation ◽

10.1111/joor.12539 ◽

2017 ◽

Vol 44 (10) ◽

pp. 800-826 ◽

Cited By ~ 26

Author(s):

B. Häggman-Henrikson ◽

P. Alstergren ◽

T. Davidson ◽

E. D. Högestätt ◽

P. Östlund ◽

...

Keyword(s):

Systematic Review ◽

Health Technology Assessment ◽

Technology Assessment ◽

Pharmacological Treatment ◽

Facial Pain ◽

Meta Analysis ◽

Health Technology

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Treatment of haemophilia A and B and von Willebrand’s disease: summary and conclusions of a systematic review as part of a Swedish health-technology assessment

Haemophilia ◽

10.1111/j.1365-2516.2011.02723.x ◽

2011 ◽

Vol 18 (2) ◽

pp. 158-165 ◽

Cited By ~ 30

Author(s):

E. BERNTORP ◽

J. ASTERMARK ◽

F. BAGHAEI ◽

D. BERGQVIST ◽

M. HOLMSTRÖM ◽

...

Keyword(s):

Systematic Review ◽

Health Technology Assessment ◽

Technology Assessment ◽

Health Technology ◽

Haemophilia A ◽

Von Willebrand's Disease ◽

Von Willebrand’S Disease

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Blockchains, Formulary Evaluations and Health Technology Assessment

INNOVATIONS in pharmacy ◽

10.24926/iip.v9i4.1445 ◽

2018 ◽

Vol 9 (4) ◽

pp. 2

Author(s):

Paul Langley ◽

Robert E Martin

Keyword(s):

Health Technology Assessment ◽

Real Time ◽

Technology Assessment ◽

Low Cost ◽

Lifetime Cost ◽

Health Technology ◽

Evidence Base ◽

Final Report ◽

Assessment Protocol ◽

Article Type

Blockchains have the potential, if appropriately implemented and managed, of contributing to a fundamental change in the application of techniques of health technology assessment in formulary decision making. Rather than continuing to rely on claims made by manufacturers that are non-evaluable, the introduction of blockchains as adjunct to the electronic medical record, meet an unmet medical need in enabling a platform for the real time assessment of claims. Rather than focusing the case for their product on lifetime cost-per-QALY models, which have no chance of ever being validated, the blockchain platform offers a low cost opportunity for claims evaluation. Manufacturers would be required to abandon the construction of imaginary cost-per-QALY worlds to support claims for pricing and formulary trier position, in favor of claims that can be evaluated and reported back to formulary committees in a short yet meaningful time horizon. Manufacturers would present a claims assessment protocol as part of the formulary submission package. If agreed with the formulary committee, the protocol would be implemented and managed through the patient blockchain membership. Claims would be monitored and evaluated in real time with a final report to the formulary committee in a matter of months. Lifetime imaginary claims for cost-per-QALY, set alongside willingness-to-pay thresholds, would be a thing of the past. Pricing decisions and formulary placement would reflect a robust evidence base and not just extrapolations from pivotal clinical trials. Article Type: Commentary

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A toolkit of methods of development-focused health technology assessment

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462321000507 ◽

2021 ◽

Vol 37 (1) ◽

Author(s):

Janet Bouttell ◽

Andrew Briggs ◽

Neil Hawkins

Keyword(s):

Literature Review ◽

Health Technology Assessment ◽

Technology Assessment ◽

Technology Development ◽

Health Technology ◽

Evidence Base ◽

Analytic Modeling ◽

Stakeholder Consultation ◽

Performance Requirements ◽

Multiple Markets

Abstract Health technology assessment conducted to inform decisions during technology development (development-focused or DF-HTA) has a number of distinct features compared with HTA conducted to inform reimbursement and usage decisions. In particular, there are a broad range of decisions to be informed related to the development of a technology; multiple markets and decision makers to be considered; a limited (and developing) evidence base; and constrained resources for analysis. These features impact upon methods adopted by analysts. In this paper, we (i) set out methods of DF-HTA against a timeline of technology development; (ii) provide examples of the methods’ use; and (iii) explain how they have been adapted as a result of the features of DF-HTA. We present a toolkit of methods for analysts working with developers of medical technologies. Three categories of methods are described: literature review, stakeholder consultation, and decision analytic modeling. Literature review and stakeholder consultation are often used to fill evidence gaps. Decision analytic modeling is used to synthesize available evidence alongside plausible assumptions to inform developers about price or performance requirements. Methods increase in formality and complexity as the development and evidence base progresses and more resources are available for assessment. We hope this toolkit will be used in conjunction with the framework of features of DF-HTA presented in our earlier article in order to improve the clarity and appropriateness of methods of HTA used in DF-HTA. We also seek to contribute to a continuing dialogue about the nature of, and the best approach to, DF-HTA.

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International guidelines for self-report and proxy completion of paediatric health-related quality of life measures: a protocol for a systematic review

BMJ Open ◽

10.1136/bmjopen-2021-052049 ◽

2021 ◽

Vol 11 (12) ◽

pp. e052049

Author(s):

Christine Mpundu-Kaambwa ◽

Gang Chen ◽

Kim Dalziel ◽

Nancy Devlin ◽

Julie Ratcliffe

Keyword(s):

Quality Of Life ◽

Systematic Review ◽

Health Technology Assessment ◽

Technology Assessment ◽

Health Technology ◽

Health Related Quality ◽

Related Quality ◽

Health Related ◽

Guidelines And Recommendations

IntroductionMeasures of health-related quality of life (HRQoL), accompanied by the values (or utilities) required to estimate quality-adjusted life-years, are crucial for determining health benefits within economic evaluation and health technology assessment. Several generic and condition-specific measures or instruments of HRQoL, accompanied by values, currently exist for application with child populations. However, there is a lack of a structured summary of guidelines and recommendations for applying these measures in practice. This protocol describes a systematic review of guidelines and recommendations for child and proxy completion of child-specific measures of HRQoL. The aims of the review are to (1) identify and summarise published guidelines and recommendations for existing child-specific measures of HRQoL, (2) determine whether the identified guidelines and recommendations differ by instrument and child characteristics, (3) identify current gaps in these guidelines and recommendations and (4) identify best practices for child self and proxy assessment in paediatric HRQoL measurement for economic evaluation and health technology assessment.Methods and analysisThe review will identify, collate and synthesise published guidelines and recommendations for existing child-specific utility measures of HRQoL. Electronic databases to be searched include the Cochrane Library, Medline, Scopus, Web of Science, EconLit, PsycINFO, CINAHL, Embase and Informit. The search will be extended to websites of (1) international organisations for health technology assessment, (2) regulation, health economics and HRQoL outcomes research and (3) instrument developers. Three reviewers will independently screen titles and abstracts against the inclusion criteria. A narrative synthesis will describe the key features of the guidelines identified.Ethics and disseminationEthical approval is not required as the proposed systematic review will not use primary data. A paper of the systematic review will be submitted to a peer-reviewed journal for publication.PROSPERO registration numberCRD42020207160.

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Prognostic biomarkers to identify patients likely to develop severe Crohn’s disease: a systematic review

Health Technology Assessment ◽

10.3310/hta25450 ◽

2021 ◽

Vol 25 (45) ◽

pp. 1-66

Author(s):

Steve Halligan ◽

Darren Boone ◽

Lucinda Archer ◽

Tariq Ahmad ◽

Stuart Bloom ◽

...

Keyword(s):

Systematic Review ◽

Crohn’S Disease ◽

Crohn's Disease ◽

Health Technology Assessment ◽

Technology Assessment ◽

Meta Analysis ◽

Severe Disease ◽

Health Technology ◽

Risk Of Bias ◽

Clinical Biomarkers

Background Identification of biomarkers that predict severe Crohn’s disease is an urgent unmet research need, but existing research is piecemeal and haphazard. Objective To identify biomarkers that are potentially able to predict the development of subsequent severe Crohn’s disease. Design This was a prognostic systematic review with meta-analysis reserved for those potential predictors with sufficient existing research (defined as five or more primary studies). Data sources PubMed and EMBASE searched from inception to 1 January 2016, updated to 1 January 2018. Review methods Eligible studies were studies that compared biomarkers in patients who did or did not subsequently develop severe Crohn’s disease. We excluded biomarkers that had insufficient research evidence. A clinician and two statisticians independently extracted data relating to predictors, severe disease definitions, event numbers and outcomes, including odds/hazard ratios. We assessed risk of bias. We searched for associations with subsequent severe disease rather than precise estimates of strength. A random-effects meta-analysis was performed separately for odds ratios. Results In total, 29,950 abstracts yielded just 71 individual studies, reporting 56 non-overlapping cohorts. Five clinical biomarkers (Montreal behaviour, age, disease duration, disease location and smoking), two serological biomarkers (anti-Saccharomyces cerevisiae antibodies and anti-flagellin antibodies) and one genetic biomarker (nucleotide-binding oligomerisation domain-containing protein 2) displayed statistically significant prognostic potential. Overall, the strongest association with subsequent severe disease was identified for Montreal B2 and B3 categories (odds ratio 4.09 and 6.25, respectively). Limitations Definitions of severe disease varied widely, and some studies confounded diagnosis and prognosis. Risk of bias was rated as ‘high’ in 92% of studies overall. Some biomarkers that are used regularly in daily practice, for example C-reactive protein, were studied too infrequently for meta-analysis. Conclusions Research for individual biomarkers to predict severe Crohn’s disease is scant, heterogeneous and at a high risk of bias. Despite a large amount of potential research, we encountered relatively few biomarkers with data sufficient for meta-analysis, identifying only eight biomarkers with potential predictive capability. Future work We will use existing data sets to develop and then validate a predictive model based on the potential predictors identified by this systematic review. Contingent on the outcome of that research, a prospective external validation may prove clinically desirable. Study registration This study is registered as PROSPERO CRD42016029363. 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. 25, No. 45. See the NIHR Journals Library website for further project information.

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