scholarly journals A Health Technology Assessment in Maxillofacial Cancer Surgery by Using the Six Sigma Methodology

Author(s):  
Carlo Ricciardi ◽  
Giovanni Dell’Aversana Orabona ◽  
Ilaria Picone ◽  
Imma Latessa ◽  
Antonella Fiorillo ◽  
...  

Squamous cell carcinoma represents the most common cancer affecting the oral cavity. At the University of Naples “Federico II”, two different antibiotic protocols were used in patients undergoing oral mucosa cancer surgery from 2006 to 2018. From 2011, there was a shift; the combination of Cefazolin plus Clindamycin as a postoperative prophylactic protocol was chosen. In this paper, a health technology assessment (HTA) is performed by using the Six Sigma and DMAIC (Define, Measure, Analyse, Improve, Control) cycle in order to compare the performance of the antibiotic protocols according to the length of hospital stay (LOS). The data (13 variables) of two groups were collected and analysed; overall, 136 patients were involved. The American Society of Anaesthesiologist score, use of lymphadenectomy or tracheotomy and the presence of infections influenced LOS significantly (p-value < 0.05) in both groups. Then, the groups were compared: the overall difference between LOS of the groups was not statistically significant, but some insights were provided by comparing the LOS of the groups according to each variable. In conclusion, in light of the insights provided by this study regarding the comparison of two antibiotic protocols, the utilization of DMAIC cycle and Six Sigma tools to perform HTA studies could be considered in future research.

2021 ◽  
Vol 2021 ◽  
pp. 1-11
Author(s):  
Alfonso Maria Ponsiglione ◽  
Carlo Ricciardi ◽  
Arianna Scala ◽  
Antonella Fiorillo ◽  
Alfonso Sorrentino ◽  
...  

Background. The Health Technology Assessment (HTA) is used to evaluate health services, manage healthcare processes more efficiently, and compare medical technologies. The aim of this paper is to carry out an HTA study that compares two pharmacological therapies and provides the clinicians with two models to predict the length of hospital stay (LOS) of patients undergoing oral cavity cancer surgery on the bone tissue. Methods. The six Sigma method was used as a tool of HTA; it is a technique of quality management and process improvement that combines the use of statistics with a five-step procedure: “Define, Measure, Analyze, Improve, Control” referred to in the acronym DMAIC. Subsequently, multiple linear regression has been used to create two models. Two groups of patients were analyzed: 45 were treated with ceftriaxone while 48 were treated with the combination of cefazolin and clindamycin. Results. A reduction of the overall mean LOS of patients undergoing oral cavity cancer surgery on bone was observed of 40.9% in the group treated with ceftriaxone. Its reduction was observed in all the variables of the ceftriaxone group. The best results are obtained in younger patients (−54.1%) and in patients with low oral hygiene (−52.4%) treated. The regression results showed that the best LOS predictors for cefazolin/clindamycin are ASA score and flap while for ceftriaxone, in addition to these two, oral hygiene and lymphadenectomy are the best predictors. In addition, the adjusted R squared showed that the variables considered explain most of the variance of LOS. Conclusion. SS methodology, used as an HTA tool, allowed us to understand the performance of the antibiotics and provided variables that mostly influence postoperative LOS. The obtained models can improve the outcome of patients, reducing the postoperative LOS and the relative costs, consequently increasing patient safety, and improving the quality of care provided.


Author(s):  
Olina Efthymiadou ◽  
Panos Kanavos

Abstract Background Managed Entry Agreements (MEAs) are increasingly used to address uncertainties arising in the Health Technology Assessment (HTA) process due to immature evidence of new, high-cost medicines on their real-world performance and cost-effectiveness. The literature remains inconclusive on the HTA decision-making factors that influence the utilization of MEAs. We aimed to assess if the uptake of MEAs differs between countries and if so, to understand which HTA decision-making criteria play a role in determining such differences. Methods All oncology medicines approved since 2009 in Australia, England, Scotland, and Sweden were studied. Four categories of variables were collected from publicly available HTA reports of the above drugs: (i) Social Value Judgments (SVJs), (ii) Clinical/Economic evidence submitted, (iii) Interpretation of this evidence, and (iv) Funding decision. Conditional/restricted decisions were coded as Listed With Conditions (LWC) other than an MEA or LWC including an MEA (LWCMEA). Cohen's κ-scores measured the inter-rater agreement of countries on their LWCMEA outcomes and Pearson's chi-squared tests explored the association between HTA variables and LWCMEA outcomes. Results A total of 74 drug-indication pairs were found resulting in n = 296 observations; 8 percent (n = 23) were LWC and 55 percent (n = 163) were LWCMEA. A poor-to-moderate agreement existed between countries (−.29 < κ < .33) on LWCMEA decisions. Cross-country differences within the LWCMEA sample were partly driven by economic uncertainties and largely driven by SVJs considered across agencies. Conclusions A set of HTA-related variables driving the uptake of MEAs across countries was identified. These findings can be useful in future research aimed at informing country-specific, “best-practice” guidelines for successful MEA implementation.


Author(s):  
Imma Latessa ◽  
Carlo Ricciardi ◽  
Deborah Jacob ◽  
Halldór Jónsson Jr ◽  
Monica Gambacorta ◽  
...  

The purpose of this study is to use Health Technology Assessment (HTA) through the Six Sigma (SS) and DMAIC (Define, Measure, Analyse, Improve, Control) problem-solving strategies for comparing cemented and uncemented prostheses in terms of the costs incurred for Total hip arthroplasty (THA) and the length of hospital stay (LOS). Multinomial logistic regression analysis for modelling the data was also performed. Quantitative parameters extracted from gait analysis, electromyography and computed tomography images were used to compare the approaches, but the analysis did not show statistical significance. The variables regarding costs were studied with the Mann-Whitney and Kruskal-Wallis tests. No statistically significant difference between cemented and uncemented prosthesis for the total cost of LOS was found, but the cost of the surgeon had an influence on the overall expenses, affecting the cemented prosthetic approach. The material costs of surgery for the uncemented prosthesis and the cost of theatre of surgery for the cemented prosthesis were the most influential. Multinomial logistic regression identified the Vastus Lateralis variable as statistically significant. The overall accuracy of the model is 93.0%. The use of SS and DMAIC cycle as tools of HTA proved that the cemented and uncemented approaches for THA have similar costs and LOSy.


2019 ◽  
Vol 35 (03) ◽  
pp. 189-194
Author(s):  
Julie Polisena ◽  
Gerhard Trunk ◽  
Iñaki Gutierrez-Ibarluzea ◽  
Roberta Joppi

AbstractObjectivesAs healthcare decision makers continue to face challenges in health services delivery to their patients, disinvestment programs are being established for a sustainable healthcare system. This study aimed to collect data and information by means of a survey of disinvestment candidates and ongoing disinvestment projects in the health technology assessment (HTA) community.MethodsAn online survey was conducted to collect information on disinvestment candidates and activities from members of the Health Technology Assessment International Disinvestment &amp; Early Awareness Interest Group, the EuroScan International Network and International Network of Agencies for Health Technology Assessment.ResultsAmong the 362 invitees, twenty-four unique responses were received, and almost 70 percent were involved in disinvestment initiatives. The disinvestment candidates identified represented a range of health technologies. Evidence or signaling of clinical ineffectiveness or inappropriate use typically led to the nomination of disinvestment candidates. Health technology assessments and reassessments were usually conducted to evaluate the technology in question, and decisions usually led to the limited use of the technology. Barriers to disinvestment decisions included the strength of interest and advocacy groups, insufficient data for assessments, a systematic decision process and political challenges, while obstacles to their implementation were clinicians’ reluctance and insufficient funding and incentives.ConclusionsThe survey results suggested that disinvestment activities are occurring in the HTA community, especially in the public sector. Future research can further investigate the processes and methods used to reach and implement disinvestment decisions from our survey respondents and explore to form closer ties between the HTA and clinical communities.


Healthcare ◽  
2022 ◽  
Vol 10 (1) ◽  
pp. 124
Author(s):  
Carlo Ricciardi ◽  
Adelmo Gubitosi ◽  
Donatella Vecchione ◽  
Giuseppe Cesarelli ◽  
Francesco De Nola ◽  
...  

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.


2022 ◽  
Vol 12 (1) ◽  
Author(s):  
Juan Carlos Rejon-Parrilla ◽  
Jaime Espin ◽  
David Epstein

Abstract Background What constitutes innovation in health technologies can be defined and measured in a number of ways and it has been widely researched and published about. However, while many countries mention it as a criterion for pricing or reimbursement of health technologies, countries differ widely in how they define and operationalise it. Methods We performed a literature review, using a snowballing search. In this paper, we explore how innovation has been defined in the literature in relation to health technology assessment. We also describe how a selection of countries (England, France, Italy, Spain and Japan) take account of innovation in their health technology assessment frameworks and explore the key methodologies that can capture it as a dimension of value in a new health technology. We propose a way of coming to, and incorporating into health technology assessment systems, a definition of innovation for health technologies that is independent of other dimensions of value that they already account for in their systems, such as clinical benefit. We use Spain as an illustrative example of how innovation might be operationalised as a criterion for decision making in health technology assessment. Results The countries analysed here can be divided into 2 groups with respect to how they define innovation. France, Japan and Italy use features such as severity, unmet need and therapeutic added value as indicators of the degree of innovation of a health technology, while England, Spain consider the degree of innovation as a separate and additional criterion from others. In the case of Spain, a notion of innovation might be constructed around concepts of `step-change’, `convenience’, `strength of evidence base’ and `impact on future research & development’. Conclusions If innovation is to be used as operational criteria for adoption, pricing and reimbursement of health technologies, the concept must be clearly defined, and it ought to be independent from other value dimensions already captured in their health technology assessment systems.


2017 ◽  
Vol 33 (2) ◽  
pp. 261-269 ◽  
Author(s):  
Mary Alison Maloney ◽  
Lisa Schwartz ◽  
Daria O'Reilly ◽  
Mitchel Levine

Objectives:Value assessments of marketed drug technologies have been developed through disinvestment frameworks. Components of these frameworks are varied and implementation challenges are prevalent. The objective of this systematic literature review was to describe disinvestment framework process components for drugs and to report on framework components, challenges, and solutions.Methods:A systematic literature search was conducted using the terms: reassessment, reallocation, reinvestment, disinvestment, delist, decommission or obsolescence in MEDLINE, EMBASE, NLM PubMed, the Cochrane Library, and CINAHL from January 1, 2000, until November 14, 2015. Additional citations were identified through a gray literature search of Health Technology Assessment international (HTAi) and the International Network of Agencies for Health Technology Assessment (INAHTA) member Web sites and from bibliographies of full-text reviewed manuscripts.Results:Sixty-three articles underwent full text review and forty were included in the qualitative analysis. Framework components including disinvestment terms and definitions, identification and prioritization criteria and methods, assessment processes, stakeholders and dissemination strategies, challenges, and solutions were compiled. This review finds that stakeholders lack the political, administrative, and clinical will to support disinvestment and that there is not one disinvestment framework that is considered best practice.Conclusions:Drug technology disinvestment components and processes vary and challenges are numerous. Future research should focus on lessening value assessment challenges. This could include adopting more neutral framework terminology, setting fixed reassessment timelines, conducting therapeutic reviews, and modifying current qualitative decision-making assessment frameworks.


2020 ◽  
Vol 32 (6) ◽  
pp. 1507-1524 ◽  
Author(s):  
Carlo Ricciardi ◽  
Alfonso Sorrentino ◽  
Giovanni Improta ◽  
Vincenzo Abbate ◽  
Imma Latessa ◽  
...  

PurposeHead and neck cancers are multi-factorial diseases that can affect many sides of people's life and are due to a lot of risk factors. According to their characteristics, the treatment can be surgical, use of radiation or chemotherapy. The use of a surgical treatment can lead to surgical infections that are a main theme in medicine. At the University hospital of Naples “Federico II”, two antibiotics were employed to tackle the issue of the infections and they are compared in this paper to find which one implies the lowest length of hospital stay (LOS) and the reduction of infections.Design/methodology/approachThe Six Sigma methodology and its problem-solving strategy DMAIC (define, measure, analyse, improve, control), already employed in the healthcare sector, were used as a tool of a health technology assessment between two drugs. In this paper the DMAIC roadmap is used to compare the Ceftriaxone (administered to a group of 48 patients) and the association of Cefazolin plus Clindamycin (administered to a group of 45 patients).FindingsThe results show that the LOS of patients treated with Ceftriaxone is lower than those who were treated with the association of Cefazolin plus Clindamycin, the difference is about 41%. Moreover, a lower number of complications and infections was found in patients who received Ceftriaxone. Finally, a greater number of antibiotic shifts was needed by patients treated with Cefazolin plus Clindamycin.Research limitations/implicationsWhile the paper enhances clearly the advantages for patients' outcomes regarding the LOS and the number of complications, it did not analyse the costs of the two antibiotics.Practical implicationsEmploying the Ceftriaxone would allow the Department of Maxillofacial Surgery to obtain lower LOS and a limited number of complications/infections for recovered patients, consequently reducing the hospitalization costs.Originality/valueThere is a double value in this paper: first of all, the comparison between the two antibiotics gives an answer to one of the main issues in medicine that is the reduction of hospital-acquired infections; secondly, the Six Sigma through its DMAIC cycle can be employed also to compare two biomedical technologies as a tool of health technology assessment studies.


2019 ◽  
Vol 35 (6) ◽  
pp. 416-421 ◽  
Author(s):  
Yot Teerawattananon ◽  
Waranya Rattanavipapong ◽  
Lydia Wenxin Lin ◽  
Saudamini Vishwanath Dabak ◽  
Brent Gibbons ◽  
...  

AbstractThis paper explores the characteristics of health technology assessment (HTA) systems and practices in Asia. Representatives from nine countries were surveyed to understand each step of the HTA pathway. The analysis finds that although there are similarities in the processes of HTA and its application to inform decision making, there is variation in the number of topics assessed and the stakeholders involved in each step of the process. There is limited availability of resources and technical capacity and countries adopt different means to overcome these challenges by accepting industry submissions or adapting findings from other regions. Inclusion of stakeholders in the process of selecting topics, generating evidence, and making funding recommendations is critical to ensure relevance of HTA to country priorities. Lessons from this analysis may be instructive to other countries implementing HTA processes and inform future research on the feasibility of implementing a harmonized HTA system in the region.


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