Application of DMAIC Cycle and Modeling as Tools for Health Technology Assessment in a University Hospital

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

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

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

Why lithium should be used in patients with bipolar disorder? A scoping review and an expert opinion paper

Introduction: Lithium treatment is considered the gold standard for the long-term management of bipolar disorder and recurrent unipolar depression. It is also extremely effective in other psychiatric conditions characterized by impulsivity and aggression, and for the prevention of suicidal behaviours. Areas covered: This paper provides a scoping review and an expert commentary regarding the use of lithium in adult patients. Available information about efficacy, tolerability, dosing, and switching is analyzed, and the strategies that may be most useful in real-world clinical settings are highlighted. Expert opinion: Lithium is effective on different domains of bipolar disorder, including the long-term prevention of recurrences of affective episodes, management of acute mania as well as in the prophylaxis of all affective episodes. Lithium has been defined a 'forgotten drug,' since its use in routine clinical practice has been declined over the last 20 or 30 years. Reasons for this trend include lack of adequate training on the management of lithium side effects. Considering its efficacy, use of lithium in ordinary clinical practice should be promoted. Several strategies, such as using slow-release formulations, can be easily implemented in order to minimize lithium side effects and improve its tolerability profile

The effect of social media and infodemic on mental health during the COVID-19 pandemic: results from the COMET multicentric trial

On January 30, 2020, the World Health Organization (WHO) declared the status of pandemic due to the COVID-19 infection. The initial phases of the pandemic were characterized by uncertainty and public fears. In order to cope with such unexpected conditions, people adopted different coping strategies, including search for information, accessing Internet, and using social media. The present study based on the COMET collaborative research network aims to: (1) assess use of Internet and of social media among the Italian general population; (2) explore differences in web usage between people with pre-existing mental disorders and the general population; (3) identify changes over time in social media usage along the phase 1 of the pandemic; (4) identify the clinical, socio-demographic and contextual predictors of excessive use of social media. A significant increase in time spent on Internet, with an average time of 4.8 ± 0.02 h per day, was found in the global sample of 20,720 participants. Compared with the general population, Internet use was significantly higher in people with pre-existing mental disorders (5.2 ± 0.1 h vs. 4.9 ± 0.02; p < 0.005). According to the multivariate logistic regression model, the risk of excessive use of social media and Internet was significantly higher in people with moderate levels of depressive symptoms (OR: 1.26, CI 95%: 0.99 to 1.59, p < 0.0.005); while protective factors were being students (OR: 0.72, CI 95%: 0.53 to 0.96, p < 0.0029) and living in central Italy (OR: 0.46, CI 95%: 0.23 to 0.90, p < 0.002). The evaluation of social media and Internet use by the general population represents a first step for developing specific protective and supportive interventions for the general population, including practical suggestions on how to safely use Internet and social media

Distal motor neuropathy associated with novel EMILIN1 mutation

Abstract Elastin microfibril interface-located proteins (EMILINs) are extracellular matrix glycoproteins implicated in elastogenesis and cell proliferation. Recently, a missense mutation in the EMILIN1 gene has been associated with autosomal dominant connective tissue disorder and motor-sensory neuropathy in a single family. We identified by whole exome sequencing a novel heterozygous EMILIN1 mutation c.748C>T [p.R250C] located in the coiled coil forming region of the protein, in four affected members of an autosomal dominant family presenting a distal motor neuropathy phenotype. In affected patient a sensory nerve biopsy showed slight and unspecific changes in the number and morphology of myelinated fibers. Immunofluorescence study of a motor nerve within a muscle biopsy documented the presence of EMILIN-1 in nerve structures. Skin section and skin derived fibroblasts displayed a reduced extracellular deposition of EMILIN-1 protein with a disorganized network of poorly ramified fibers in comparison with controls. Downregulation of emilin1a in zebrafish displayed developmental delay, locomotion defects, and abnormal axonal arborization from spinal cord motor neurons. The phenotype was complemented by wild-type zebrafish emilin1a, and partially the human wild-type EMILIN1 cRNA, but not by the cRNA harboring the novel c.748C>T [p.R250C]. These data suggest a role of EMILIN-1 in the pathogenesis of diseases affecting the peripheral nervous system

The effects of psychoeducational family intervention on coping strategies of relatives of patients with bipolar i disorder: Results from a controlled, real-world, multicentric study

Background: Psychoeducational family intervention (PFI) has been proven to be effective in improving the levels of family burden and patients\u2019 personal functioning in schizophrenia and bipolar disorders (BDs). Less is known about the impact of PFI on relatives\u2019 coping strategies in BD. Methods: A multicenter, controlled, outpatient trial funded by the Italian Ministry of Health and coordinated by the Department of Psychiatry of the University of Campania \u201cLuigi Vanvitelli\u201d has been conducted in patients with bipolar I disorder (BD-I) and their key relatives consecutively recruited in 11 randomly selected Italian community mental health centers. We aim to test the hypothesis that PFI improves problem-oriented coping strategies in relatives of BD-I patients compared to the Treatment As Usual (TAU) group. Results: The final sample was constituted of 123 patients and 139 relatives. At baseline assessment (T0), the vast majority of relatives already adopted problem-oriented coping strategies more frequently than the emotion-focused ones. At the end of the intervention, relatives receiving PFI reported a higher endorsement of adaptive coping strategies, such as \u201cmaintenance of social interests\u201d (odds ratio [OR]=0.309, CI=0.04\u20130.57; p=0.023), \u201cpositive communication with the patient\u201d (OR=0.295, CI=0.13\u20130.46; p=0.001), and \u201csearching for information\u201d (OR=0.443, CI=0.12\u20130.76; p=0.007), compared to TAU relatives, after controlling for several confounders. As regards the emotion-focused coping strategies, relatives receiving the experimental intervention less frequently reported to adopt \u201cresignation\u201d (OR=-0.380, CI=-0.68 to -0.08; p=0.014) and \u201ccoercion\u201d (OR=-0.268, CI=-0.46 to -0.08; p=0.006) strategies, compared to TAU relatives. Conclusion: PFI is effective in improving the adaptive coping strategies of relatives of BD-I patients, but further studies are needed for evaluating the long-term benefits of this intervention

Implementing a guideline for the treatment of type 2 diabetics: results of a Cluster- Randomized Controlled Trial (C-RCT)

<p>Abstract</p> <p>Background</p> <p>In Italy many diabetics still lack adequate care in general practice. We assessed the effectiveness of different strategies for the implementation of an evidence-based guideline for the management of non-complicated type 2 diabetes among General Practitioners (GPs) of Lazio region.</p> <p>Methods</p> <p>Three-arm cluster-randomised controlled trial with GPs as units of randomisation (clusters). 252 GPs were randomised either to an active strategy (training module with administration of the guideline), or to a passive dissemination (administration of the guideline only), or to usual care (control). Data on prescriptions of tests and drugs were collected by existing information systems, whereas patients' data came from GPs' databases. Process outcomes were measured at the cluster level one year after the intervention. Primary outcomes concerned the measurement of glycosilated haemoglobin and the commissioning of micro- and macrovascular complications assessment tests. In order to assess the physicians' drug prescribing behaviour secondary outcomes were also calculated.</p> <p>Results</p> <p>GPs identified 6395 uncomplicated type 2 patients with a high prevalence of cardiovascular risk factors. Data on GPs baseline performance show low proportions of glycosilated haemoglobin assessments. Results of the C-RCT analysis indicate that the active implementation strategy was ineffective relating to all primary outcomes (respectively, OR 1.06 [95% IC: 0.76–1.46]; OR 1.07 [95% IC: 0.80–1.43]; OR 1.4 [95% IC:0.91–2.16]. Similarly, passive dissemination of the guideline showed no effect.</p> <p>Conclusion</p> <p>In our region compliance of GPs with guidelines was not enhanced by a structured learning programme. Implementation through organizational measures appears to be essential to induce behavioural changes.</p> <p>Trial registration</p> <p>ISRCTN80116232</p

The effect of social media and infodemic on mental health during the COVID-19 pandemic: results from the COMET multicentric trial

On January 30, 2020, the World Health Organization (WHO) declared the status of pandemic due to the COVID-19 infection. The initial phases of the pandemic were characterized by uncertainty and public fears. In order to cope with such unexpected conditions, people adopted different coping strategies, including search for information, accessing Internet, and using social media. The present study based on the COMET collaborative research network aims to: (1) assess use of Internet and of social media among the Italian general population; (2) explore differences in web usage between people with pre-existing mental disorders and the general population; (3) identify changes over time in social media usage along the phase 1 of the pandemic; (4) identify the clinical, socio-demographic and contextual predictors of excessive use of social media. A significant increase in time spent on Internet, with an average time of 4.8  ±  0.02 h per day, was found in the global sample of 20,720 participants. Compared with the general population, Internet use was significantly higher in people with pre-existing mental disorders (5.2  ± 0.1 h vs. 4.9  ±  0.02; p &lt; 0.005). According to the multivariate logistic regression model, the risk of excessive use of social media and Internet was significantly higher in people with moderate levels of depressive symptoms (OR: 1.26, CI 95%: 0.99 to 1.59, p &lt; 0.0.005); while protective factors were being students (OR: 0.72, CI 95%: 0.53 to 0.96, p &lt; 0.0029) and living in central Italy (OR: 0.46, CI 95%: 0.23 to 0.90, p &lt; 0.002). The evaluation of social media and Internet use by the general population represents a first step for developing specific protective and supportive interventions for the general population, including practical suggestions on how to safely use Internet and social media

How future surgery will benefit from SARS-COV-2-related measures: a SPIGC survey conveying the perspective of Italian surgeons

COVID-19 negatively affected surgical activity, but the potential benefits resulting from adopted measures remain unclear. The aim of this study was to evaluate the change in surgical activity and potential benefit from COVID-19 measures in perspective of Italian surgeons on behalf of SPIGC. A nationwide online survey on surgical practice before, during, and after COVID-19 pandemic was conducted in March-April 2022 (NCT:05323851). Effects of COVID-19 hospital-related measures on surgical patients' management and personal professional development across surgical specialties were explored. Data on demographics, pre-operative/peri-operative/post-operative management, and professional development were collected. Outcomes were matched with the corresponding volume. Four hundred and seventy-three respondents were included in final analysis across 14 surgical specialties. Since SARS-CoV-2 pandemic, application of telematic consultations (4.1% vs. 21.6%; p &lt; 0.0001) and diagnostic evaluations (16.4% vs. 42.2%; p &lt; 0.0001) increased. Elective surgical activities significantly reduced and surgeons opted more frequently for conservative management with a possible indication for elective (26.3% vs. 35.7%; p &lt; 0.0001) or urgent (20.4% vs. 38.5%; p &lt; 0.0001) surgery. All new COVID-related measures are perceived to be maintained in the future. Surgeons' personal education online increased from 12.6% (pre-COVID) to 86.6% (post-COVID; p &lt; 0.0001). Online educational activities are considered a beneficial effect from COVID pandemic (56.4%). COVID-19 had a great impact on surgical specialties, with significant reduction of operation volume. However, some forced changes turned out to be benefits. Isolation measures pushed the use of telemedicine and telemetric devices for outpatient practice and favored communication for educational purposes and surgeon-patient/family communication. From the Italian surgeons' perspective, COVID-related measures will continue to influence future surgical clinical practice