Publications by authors named "Giuseppe Turchetti"

70 Publications

State of the art and challenges for the classification of studies on electromechanical and robotic devices in neurorehabilitation: a scoping review.

Eur J Phys Rehabil Med 2021 May 27. Epub 2021 May 27.

Department of Electrical and Information Engineering, Politecnico di Bari, Italy.

Introduction: The rapid development of electromechanical and robotic devices has profoundly influenced neurorehabilitation. Growth in the scientific and technological aspects thereof is crucial for increasing the number of newly developed devices, and clinicians have welcomed such growth with enthusiasm. Nevertheless, improving the standard for the reporting clinical, technical, and normative aspects of such electromechanical and robotic devices remains an unmet need in neurorehabilitation. Accordingly, this study aimed to analyse the existing literature on electromechanical and robotic devices used in neurorehabilitation, considering the current clinical, technical, and regulatory classification systems.

Evidence Acquisition: Within the CICERONE Consensus Conference framework, studies on electromechanical and robotic devices used for upper- and lower-limb rehabilitation in persons with neurological disabilities in adulthood and childhood were reviewed. We have conducted a literature search using the following databases: MEDLINE, Cochrane Library, PeDro, Institute of Electrical and Electronics Engineers, Science Direct, and Google Scholar. Clinical, technical, and regulatory classification systems were applied to collect information on the electromechanical and robotic devices. The study designs and populations were investigated.

Evidence Synthesis: Overall, 316 studies were included in the analysis. More than half (52%) of the studies were randomised controlled trials (RCTs). The population investigated the most suffered from strokes, followed by spinal cord injuries, multiple sclerosis, cerebral palsy, and traumatic brain injuries. In total, 100 devices were described; of these, 19% were certified with the CE mark. Overall, the main type of device was an exoskeleton. However, end-effector devices were primarily used for the upper limbs, whereas exoskeletons were used for the lower limbs (for both children and adults).

Conclusions: The current literature on robotic neurorehabilitation lacks detailed information regarding the technical characteristics of the devices used. This affects the understanding of the possible mechanisms underlying recovery. Unfortunately, many electromechanical and robotic devices are not provided with CE marks, strongly hindering the research on the clinical outcomes of rehabilitation treatments based on these devices. A more significant effort is needed to improve the description of the robotic devices used in neurorehabilitation in terms of the technical and functional details, along with high-quality RCT studies.
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http://dx.doi.org/10.23736/S1973-9087.21.06922-7DOI Listing
May 2021

Robotic-assisted gait rehabilitation following stroke: a systematic review of current guidelines and practical clinical recommendations.

Eur J Phys Rehabil Med 2021 May 5. Epub 2021 May 5.

Rehabilitation Unit, ULSS (Local Health Authority) Euganea - Camposampiero Hospital, Padua, Italy.

Introduction: Stroke is the third leading cause of adult disability world-wide, and lower extremity motor impairment is one of the major determinants of long-term disability. Although robotic therapy is becoming more and more utilized in research protocols for lower limb stroke rehabilitation, the gap between research evidence and its use in clinical practice is still significant. The aim of this study was to determine the scope, quality, and consistency of guidelines for robotic lower limb rehabilitation after stroke, in order to provide clinical recommendations.

Evidence Acquisition: We systematically reviewed stroke rehabilitation guideline recommendations between January 1st, 2010 and October 31th, 2020. We explored electronic databases (n=4), guideline repositories and professional rehabilitation networks (n=12). Two independent reviewers used the Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument, and brief syntheses were used to evaluate and compare the different recommendations, considering only the most recent version.

Evidence Synthesis: From the 1219 papers screened, ten eligible guidelines were identified from seven different regions/countries. Four of the included guidelines focused on stroke management, the other six on stroke rehabilitation. Robotic rehabilitation is generally recommended to improve lower limb motor function, including gait and strength. Unfortunately, there is still no consensus about the timing, frequency, training session duration and the exact characteristics of subjects who could benefit from robotics.

Conclusions: Our systematic review shows that the introduction of robotic rehabilitation in standard treatment protocols seems to be the future of stroke rehabilitation. However, robot assisted gait training (RAGT) for stroke needs to be improved with new solutions and in clinical practice guidelines, especially in terms of applicability.
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http://dx.doi.org/10.23736/S1973-9087.21.06887-8DOI Listing
May 2021

Duration of response after DEB-TACE compared to lipiodol-TACE in HCC-naïve patients: a propensity score matching analysis.

Eur Radiol 2021 Apr 19. Epub 2021 Apr 19.

Department of Interventional Radiology, Pisa University Hospital, Via Paradisa 2, 56126, Pisa, Italy.

Objectives: To retrospectively compare long-term outcomes of first-line drug-eluting particle (DEB)- transarterial chemoembolization (TACE) and lipiodol-TACE, in patients with unresectable hepatocellular (HCC).

Methods: We retrospectively reviewed our database to identify adult patients with treatment-naïve unresectable HCC, who underwent TACE from 2006 to 2013. Patients were excluded in the absence of complete medical records relative to first TACE, 1-month follow-up, and/or sufficient follow-up data. Periprocedural complications, duration of hospitalization, 1-month tumor response by mRECIST, time to tumor progression (TTP) and target tumor progression (TTTP), and overall survival (OS) were evaluated.

Results: Out of an initial series of 656 patients, 329 patients were excluded for unavailability of sufficient baseline and/or follow-up data. The remaining 327 patients underwent either lipiodol-TACE (n = 160) or DEB-TACE (n = 167). Patients treated with lipiodol-TACE had a significantly higher tumor burden. By propensity score, patients were matched according to baseline differences (BCLC stage, uninodular or multinodular HCC, and unilobar or bilobar HCC), resulting in 101 patients in each treatment group. Lipiodol-TACE was associated with a significantly higher incidence of adverse events (p = 0.03), and longer hospitalization (mean, 2.5 days vs 1.9 days; p = 0.03), while tumor response, TTP, and OS were comparable. In patients achieving 1-month complete response (CR) of target tumor, TTTP was significantly (p = 0.009) longer after DEB-TACE compared to lipiodol-TACE (median, 835 vs 353 days), resulting in a lower number of re-treatments during the entire follow-up (0.75 vs 1.6, p = 0.01).

Conclusion: Compared to lipiodol-TACE, DEB-TACE offers higher tolerability, reduced hospitalization, and more durable target tumor response after CR.

Key Points: • Compared to lipiodol-TACE, DEB-TACE is better tolerated and has reduced side effects, which translates into shorter hospitalization. • When complete radiological response according to the mRECIST is obtained 1 month after the procedure, DEB-TACE offers a more durable local tumor control compared to lipiodol-TACE. • In these patients, the longer duration of response after DEB-TACE translates into a lower number of re-interventions.
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http://dx.doi.org/10.1007/s00330-021-07905-xDOI Listing
April 2021

Effects of robot-assisted gait training on postural instability in Parkinson's disease: a systematic review.

Eur J Phys Rehabil Med 2021 Apr 7. Epub 2021 Apr 7.

Valduce Villa Beretta Hospital, Costa Masnaga, Lecco, Italy.

Introduction: Postural instability is a cardinal feature of Parkinson's disease, together with rest tremor, rigidity and bradykinesia. It is a highly disabling symptom that becomes increasingly common with disease progression and represents a major source of reduced quality of life in patients with Parkinson's disease. Rehabilitation aims to enable patients with Parkinson's disease to maintain their maximum level of mobility, activity and independence. To date, a wide range of rehabilitation approaches has been employed to treat postural instability in Parkinson's disease, including robotic training. Our main aim was to conduct a systematic review of current literature about the effects of robot-assisted gait training on postural instability in patients with Parkinson's disease.

Evidence Acquisition: A systematic search using the following MeSH terms (Parkinson disease; postural balance; robotics; rehabilitation) and string {("robotics [mh]" OR "robot-assisted" OR "electromechanical") and ("rehabilitation [mh]" OR "training") and ("postural balance [mh]")} was conducted on PubMed, Cochrane Library and PEDro electronic databases. Full text articles in English published up to December 2020 were included. Data about patient characteristics, robotic devices, treatment procedures and outcome measures were considered. Every included article got checked for quality. Level of evidence was defined for all studies.

Evidence Synthesis: Three authors independently extracted and verified data. In total, 18 articles (2 systematic reviews, 9 randomized controlled trials, 4 uncontrolled studies and 3 case series/case reports) were included. Both end-effector and exoskeleton devices were investigated as to robot-assisted gait training modalities. No clear relationship between treatment parameters and clinical conditions was observed. We found a high level of evidence about the effects of robot-assisted gait training on balance and freezing of gait in patients with Parkinson's disease.

Conclusions: This systematic review provides to the reader a complete overview of current literature and levels of evidence about the effects of robot-assisted gait training on postural instability issues (static and dynamic balance, freezing of gait, falls, confidence in activities of daily living and gait parameters related to balance skills) in patients with Parkinson's disease.
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http://dx.doi.org/10.23736/S1973-9087.21.06939-2DOI Listing
April 2021

Understanding eating choices among university students: A study using data from cafeteria cashiers' transactions.

Health Policy 2021 May 10;125(5):665-673. Epub 2021 Jan 10.

Institute of Management and Department of Excellence EMbeDS, Scuola Superiore Sant'Anna, Pisa, Italy.

Objective: To illustrate the use of automatically collected data from cashier transactions to understand eating habits among university students using cafeteria and to identify individual characteristics associated with the diverse behaviors.

Methods: The study was carried out at a large university located in Pisa, central Italy, using data about meals automatically recorded from cashier transaction meals during the academic year 2015-16 as well as data from the administrative archive of the university. A model-based clustering relying on multivariate beta distribution was used to cluster eating choices while multivariate multinomial logistic regressions were applied to identify variables associated to diverse clusters identified.

Results: Considering 4643 students and about 200,000 meals consumed, results suggest that healthy eaters represented a minority (11.2 %) of the study population while the large part of students composed their meals combining grains with processed food or proteins (32.7 %) and limiting the choice of fruit (42.9 %). Male gender and younger age were associated with eating behavior not in line with recommendations for a healthy diet.

Conclusions: Eating choice resulted to be "compromised" in most of students and specific characteristics associated with unhealthy choice were also identified that can help inform and target specific policy. The use of routinely collected data gives the opportunity to both cafeterias and university to take an active role in policy development.
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http://dx.doi.org/10.1016/j.healthpol.2020.12.019DOI Listing
May 2021

New Perspective to Improve Care of Patients with Infected Diabetic Foot Ulcer: Early Economic Impact of the Use of Photodynamic Therapy with RLP068 (Based) System.

Clinicoecon Outcomes Res 2021 26;13:135-144. Epub 2021 Feb 26.

Institute of Management, Scuola Superiore Sant'Anna, Pisa, Italy.

Objective: To perform an early economic evaluation of a system based on photodynamic advanced adjuvant therapy with photosensitizer RLP068/CI to facilitate the healing process of foot/leg skin lesions/ulcers with an excellent safety profile.

Design: An early short-term (10 weeks) cost-effectiveness and a budget impact analysis (over 5 years) comparing photodynamic therapy with photosensitizer RLP068/CI based (PDT-RLP068) system added to Standard of Care (SoC) vs SoC alone.

Setting: The Italian National Healthcare System perspective considering both the outpatient and the day-hospital regimen.

Participants: Hypothetical patients with diabetic foot infection (DFI) grades I/IIB.

Interventions: The PDT-RLP068 system as an add-on to Standard of Care (SoC) vs SoC alone as the first-line treatment for the management of DFIs.

Main Outcomes: Days within which the clinical target was achieved and direct health costs for patients' management.

Results: Additional costs generated by the use of the PDT-RLP068 system progressively decreased as time to reach the target induced by the novel system decreased. In the outpatient regimen, when time to reach clinical target decreased in the range 7-28 days, ICERs varied from about 1€ to 70€ for each additional day gained with clinical target achieved. The system was dominant when halving time to reach the target in the outpatient regimen and even for modest reduction of time in day-hospital regimen. In terms of budget impact, when considering day-hospital regimen, if the PDT-RLP068 based system allowed a shortened duration to reach the clinical target of between 7-28 days, BI was 8,100,000€ to 700,000€, with saving less than 2,000,000€ with 50% reduction of time. Considering the inpatient setting, the use of the PDT-RLP068 system would result in saving even with the modest impact on the time needed to activate the healing process.

Conclusion: The early economic evaluation performed suggested that, if the claimed effectiveness of the technology demonstrated in case reports and in preliminary clinical studies can be confirmed in larger population studies, and allowing for shortening of the time needed to activate the healing process, the PDT-RLP068 system could offer the chance to improve care for DFI patients without compromising the sustainability of the system.
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http://dx.doi.org/10.2147/CEOR.S274897DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7924247PMC
February 2021

Cost-Effectiveness of Direct Non-Vitamin K Oral Anticoagulants Versus Vitamin K Antagonists for the Management of Patients with Non-Valvular Atrial Fibrillation Based on Available "Real-World" Evidence: The Italian National Health System Perspective.

Clin Drug Investig 2021 Mar 15;41(3):255-267. Epub 2021 Feb 15.

Institute of Management, Scuola Superiore Sant'Anna, Piazza Martiri della Libertà, 33, 56127, Pisa, Italy.

Background And Objective: The increasing availability of real-world evidence (RWE) about safety and effectiveness of direct non-vitamin K oral anticoagulants (DOACs) for the management of atrial fibrillation (AF) offers the opportunity to better understand the clinical and economic implications of DOACs versus vitamin K antagonists (VKAs). The objective of this study was to compare the economic implications of DOACs and VKAs using data from real-world evidence in patients with AF.

Methods: A Markov model simulating the lifetime course of patients diagnosed with non-valvular AF was used to evaluate the cost-effectiveness of DOACs (i.e., rivaroxaban, dabigatran and apixaban) versus VKAs from the Italian National Health System (INHS) perspective. The model was made up of data from the literature and a meta-analysis of RWE on the incidence of stroke/systemic embolism (SE), major bleeding (MB), intracranial haemorrhage (ICH) and all-cause mortality (ACM); direct costs included drug costs, costs for drug monitoring, and management of events from official national lists. One-way and probabilistic sensitivity analyses (PSA) were used to assess the robustness of the results.

Results: Results from the meta-analysis showed that apixaban had a high probability of being the most effective for stroke/SE, MB and ACM. Despite their higher acquisition costs, the cost-effectiveness analysis showed all DOACs involved a saving when compared with VKAs, with per-patient savings ranging between €4647 (rivaroxaban) to €6086 (apixaban). Moreover, all DOACs indicated a gain both in quality-adjusted life-years and life-years. According to PSA, findings related to apixaban were consistent, while for dabigatran and rivaroxaban PSA revealed a higher degree of uncertainty.

Conclusions: The beneficial effect of DOACs on containing events showed in RWE had the potential to offset drug-related costs, thus improving the sustainability of treatment for non-valvular AF in daily clinical practice.
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http://dx.doi.org/10.1007/s40261-021-01002-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7946694PMC
March 2021

What is the impact of robotic rehabilitation on balance and gait outcomes in people with multiple sclerosis? A systematic review of randomized control trials.

Eur J Phys Rehabil Med 2021 Apr 4;57(2):246-253. Epub 2021 Feb 4.

IRCCS Fondazione Don Carlo Gnocchi ONLUS, Milan, Italy.

Introduction: In recent years, robot-assisted gait training (RAGT) has been proposed as therapy for balance and gait dysfunctions in people with multiple sclerosis (PwMS). Through this systematic review, we aimed to discuss the impact of RAGT on balance and gait outcomes. Furthermore, characteristics of the training in terms of robots used, participants characteristics, protocols and combined therapeutic approaches have been described.

Evidence Acquisition: As part of the Italian Consensus on robotic rehabilitation "CICERONE" a systematic search was provided in PubMed, the Cochrane Library and PEDro to identify relevant studies published before December 2019. Only randomized control trials (RCT) involving RAGT for PwMS were included. PEDro scale was used to assess the risk of bias and the Oxford Center for Evidence-Based Medicine (OCEBM) was used to assess level of evidence of included studies.

Evidence Synthesis: The search on databases resulted in 336 records and, finally, 12 studies were included. RAGT was provided with Exoskeleton in ten studies (6-40 session, 2-5 per week) and with end-effector in two studies (12 sessions, 2-3 per week) with large variability in terms of participants' disability. All the exoskeletons were combined with bodyweight support treadmill and movement assistance varied from 0% to 100% depending on participants' disability, two studies combined exoskeleton with virtual reality. The end-effector speed ranged between 1.3 and 1.8 km/h, with bodyweight support starting from 50% and progressively reduced. In seven out of twelve studies RAGT was provided in a multimodal rehabilitation program or in combination with standard physical therapy. There is level 2 evidence that RAGT has positive impact in PwMS, reaching the minimally clinically importance difference in Berg Balance Scale, six-minute walking test and gait speed.

Conclusions: In available RCT, RAGT is mostly provided with exoskeleton devices and improves balance and gait outcomes in a clinically meaningful way. Considering several advantages in terms of safety, motor assistance and intensity of training provided, RAGT should be promoted for PwMS with severe disability in a multimodal rehabilitation context as an opportunity to maximize recovery.
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http://dx.doi.org/10.23736/S1973-9087.21.06692-2DOI Listing
April 2021

Minimally invasive distal pancreatectomy: a case-matched cost-analysis between robot-assisted surgery and direct manual laparoscopy.

Surg Endosc 2021 Feb 3. Epub 2021 Feb 3.

General Surgery Unit, Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Via Paradisa 2, 56125, Pisa, Italy.

Background: Few studies have reported a structured cost analysis of robotic distal pancreatectomy (RDP), and none have compared the relative costs between the robotic-assisted surgery (RAS) and the direct manual laparoscopy (DML) in this setting. The aim of the present study is to address this issue by comparing surgical outcomes and costs of RDP and laparoscopic distal pancreatectomies (LDP).

Methods: Eighty-eight RDP and 47 LDP performed between January 2008 and January 2020 were retrospectively analyzed. Three comparable groups of 35 patients each (Si-RDP-group, Xi-RDP group, LDP-group) were obtained matching 1:1 the RDP-groups with the LDP-group. Overall costs, including overall variable costs (OVC) and fixed costs were compared using generalized linear regression model adjusting for covariates.

Results: The conversion rate was significantly lower in the Si-RDP-group and Xi-RDP-group: 2.9% and 0%, respectively, versus 14.3% in the LDP-group (p = 0.045). Although not statistically significant, the mean operative time was lower in Xi-RDP-group: 226 min versus 262 min for Si-RDP-group and 247 min for LDP-group. The overall post-operative complications rate and the length of hospital stay (LOS) were not significantly different between the three groups. In LDP-group, the LOS of converted cases was significantly longer: 15.6 versus 9.8 days (p = 0.039). Overall costs of LDP-group were significantly lower than RDP-groups, (p < 0.001). At multivariate analysis OVC resulted no longer statistically significantly different between LDP-group and Xi-RDP-group (p = 0.099), and between LDP-group and the RDP-groups when the spleen preservation was indicated (p = 0.115 and p = 0.261 for Si-RDP-group and Xi-RDP-group, respectively).

Conclusions: RAS is more expensive than DML for DP because of higher acquisition and maintenance costs. The flattening of these differences considering only the variable costs, in a high-volume multidisciplinary center for RAS, suggests a possible optimization of the costs in this setting. RAS might be particularly indicated for minimally invasive DP when the spleen preservation is scheduled.
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http://dx.doi.org/10.1007/s00464-021-08332-1DOI Listing
February 2021

Improving Treatment Adherence and Retention of HIV-Positive Women Through Behavioral Change Interventions Aimed at Their Male Partners: Protocol for a Prospective, Controlled Before-and-After Study.

JMIR Res Protoc 2021 Jan 25;10(1):e19384. Epub 2021 Jan 25.

Department of Biomedicine, University of Tor Vergata, Rome, Italy.

Background: According to the World Health Organization, in 2018, 37.9 million people were living with HIV globally. More than two-thirds were residing in sub-Saharan Africa, where the HIV prevalence in the adult population (aged 15-49 years) was 3.9%. This population included 1.3 million pregnant women, of whom 82% had received antiretroviral therapy (ART) for the prevention of HIV mother-to-child transmission. In these countries, one challenge is an insufficient level of treatment adherence, particularly in HIV-positive pregnant women. Among the causes, the lack of involvement from a male partner is a significant contributor to the problem. This issue has strongly emerged in Malawi, one of the countries with the highest HIV prevalence in the world: 9.2% of its adult population were living with HIV in 2018.

Objective: This study aims to assess 3 interventions that are aimed at improving ART adherence and retention among HIV-positive women through engagement with their male partners in 4 Malawian health care centers.

Methods: The prospective, controlled before-and-after study is conducted in 3 phases (total duration: 24 months): preintervention, intervention, and postintervention analyses. The number of selected clusters (clinical centers) is limited to 4: one for each intervention, plus a cluster where no intervention is performed (control arm). The interventions are as follows: opening the facility on one Saturday per month only for men, defined as a special day; testing peer-to-peer counseling among men, male champions; and providing a noneconomic incentive to all women who are accompanied by their partners to the facility, nudge. The primary outcome of the study is to evaluate the differences in retention in care and adherence to therapeutic protocols among women; the intermediate outcome is the assessment of differences in male involvement. The level of male involvement in the health of their partners (intermediate outcome) will be evaluated through a dedicated questionnaire administered at baseline and in the postintervention phase. Data will be collected at the clinical centers and stored in 2 electronic databases managed using 2 different types of software.

Results: The analysis of data collected in the 4 centers during the preintervention phase is ongoing, as enrollment ended on March 31, 2020. The total number of patients enrolled was 452 (Namandanje: 133; Kapeni: 78; Kapire: 75; and Balaka: 166). Meanwhile, several meetings have been conducted to organize the intervention phase.

Conclusions: The study will identify the best intervention that enhances the involvement of male partners in women's health, using an approach that considers a broad spectrum of behaviors. An important aspect is the use of educational tools focused on messages, thereby initiating a reflective discussion of stereotypes and false beliefs related to the idea of masculinity present in the Malawian culture.

International Registered Report Identifier (irrid): DERR1-10.2196/19384.
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http://dx.doi.org/10.2196/19384DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7870353PMC
January 2021

Systematic review of guidelines to identify recommendations for upper limb robotic rehabilitation after stroke.

Eur J Phys Rehabil Med 2021 Apr 25;57(2):238-245. Epub 2021 Jan 25.

Department of Mental and Physical Health and Preventive Medicine, Luigi Vanvitelli University of Campania, Naples, Italy.

Introduction: Upper limb motor impairment is one of the most frequent stroke consequences. Robot therapy may represent a valid option for upper limb stroke rehabilitation, but there are still gaps between research evidence and their use in clinical practice. The aim of this study was to determine the quality, scope, and consistency of guidelines clinical practice recommendations for upper limb robotic rehabilitation in stroke populations.

Evidence Acquisition: We searched for guideline recommendations on stroke published between January 1st, 2010 and January 1st, 2020. Only the most recent guidelines for writing group were selected. Electronic databases (N.=4), guideline repertories and professional rehabilitation networks (N.=12) were searched. We systematically reviewed and assessed guidelines containing recommendation statements about upper limb robotic rehabilitation for adults with stroke (PROSPERO registration number: CRD42020173386).

Evidence Synthesis: Four independent reviewers used the Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument, and textual syntheses were used to appraise and compare recommendations. From 1324 papers that were screened, eight eligible guidelines were identified from six different regions/countries. Half of the included guidelines focused on stroke management, the other half on stroke rehabilitation. Rehabilitation assisted by robotic devices is generally recommended to improve upper limb motor function and strength. The exact characteristics of patients who could benefit from this treatment as well as the correct timing to use it are not known.

Conclusions: This systematic review has identified many opportunities to modernize and otherwise improve stroke patients' upper limb robotic therapy. Rehabilitation assisted by robot or electromechanical devices for stroke needs to be improved in clinical practice guidelines in particular in terms of applicability.
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http://dx.doi.org/10.23736/S1973-9087.21.06625-9DOI Listing
April 2021

Is EEG Suitable for Marketing Research? A Systematic Review.

Front Neurosci 2020 21;14:594566. Epub 2020 Dec 21.

Institute of Management, Scuola Superiore Sant'Anna, Pisa, Italy.

In the past decade, marketing studies have greatly benefited from the adoption of neuroscience techniques to explore conscious and unconscious drivers of consumer behavior. Electroencephalography (EEG) is one of the most frequently applied neuroscientific techniques for marketing studies, thanks to its low cost and high temporal resolution. We present an overview of EEG applications in consumer neuroscience. The aim of this review is to facilitate future research and to highlight reliable approaches for deriving research and managerial implications. We conducted a systematic review by querying five databases for the titles of articles published up to June 2020 with the terms [EEG] AND [neuromarketing] OR [consumer neuroscience]. We screened 264 abstracts and analyzed 113 articles, classified based on research topics (e.g., product characteristics, pricing, advertising attention and memorization, rational, and emotional messages) and characteristics of the experimental design (tasks, stimuli, participants, additional techniques). This review highlights the main applications of EEG to consumer neuroscience research and suggests several ways EEG technique can complement traditional experimental paradigms. Further research areas, including consumer profiling and social consumer neuroscience, have not been sufficiently explored yet and would benefit from EEG techniques to address unanswered questions.
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http://dx.doi.org/10.3389/fnins.2020.594566DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7779633PMC
December 2020

The impact of COVID-19 on rare and complex connective tissue diseases: the experience of ERN ReCONNET.

Nat Rev Rheumatol 2021 03 6;17(3):177-184. Epub 2021 Jan 6.

Center for Medical Genetics, Ghent University Hospital, Ghent, Belgium.

During the COVID-19 pandemic, the need to provide high-level care for a large number of patients with COVID-19 has affected resourcing for, and limited the routine care of, all other conditions. The impact of this health emergency is particularly relevant in the rare connective tissue diseases (rCTDs) communities, as discussed in this Perspective article by the multi-stakeholder European Reference Network on Rare and Complex Connective Tissue and Musculoskeletal Diseases (ERN ReCONNET). The clinical, organizational and health economic challenges faced by health-care providers, institutions, patients and their families during the SARS-CoV-2 outbreak have demonstrated the importance of ensuring continuity of care in the management of rCTDs, including adequate diagnostics and monitoring protocols, and highlighted the need for a structured emergency strategy. The vulnerability of patients with rCTDs needs to be taken into account when planning future health policies, in preparation for not only the post-COVID era, but also any possible new health emergencies.
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http://dx.doi.org/10.1038/s41584-020-00565-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7786339PMC
March 2021

Correction to: Determining the cost-effectiveness requirements of an exoskeleton preventing second hip fractures using value of information.

BMC Health Serv Res 2020 Dec 20;20(1):1146. Epub 2020 Dec 20.

Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Headington, Oxford, UK.

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http://dx.doi.org/10.1186/s12913-020-06007-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7751109PMC
December 2020

RarERN Path: a methodology towards the optimisation of patients' care pathways in rare and complex diseases developed within the European Reference Networks.

Orphanet J Rare Dis 2020 12 14;15(1):347. Epub 2020 Dec 14.

Institute of Management, Scuola Superiore Sant'Anna, Piazza Martiri della Libertà, 33, 56127, Pisa, Italy.

Background: In 2017, the European Commission has launched the European Reference Networks (ERNs), virtual networks involving healthcare providers across Europe. The aim of the ERNs is to tackle complex and rare diseases and conditions that require highly specialized treatment and a concentration of knowledge and resources. The ERN on rare and complex connective tissue and musculoskeletal diseases (ERN ReCONNET) is one of the 24 ERNs approved that aims to improve the management of Rare and Complex Connective Tissue and Musculoskeletal Diseases.

Objective: The RarERN Path methodology aims to create a single reference organisational model for patients' care pathways which, if applied in different contexts, helps to ensure an improved, cost-effective and patient-centred equal care to rare and complex diseases.

Methods: Starting from existing standard methods for the creation and elaboration of patients' care pathways, a specific methodology was created in order to take advantage of the distinctive and peculiar characteristics of the ERNs. Specifically, the development of the RarERN Path methodology involved different stakeholders: health economists, clinicians and researchers expert in rare and complex diseases, communication experts, experts in patients' involvement and narrative medicine and policy-makers.

Results: The RarERN Path methodology foresees six consecutive phases, each with different and specific aims. Specifically, the six phases are represented by: Phase 1-mapping of existing patients' care pathways and patients' stories; Phase 2-design of an optimised common patients' care pathway; Phase 3-consensus on an optimised common patients' care pathway; Phase 4-key performance indicators definition; Phase 5-refinement; Phase 6-pilot phase (optional).

Conclusion: The application of RarERN Path to the different disease-specific and geographical contexts would help to ensure an improved, cost-effective and patient-centred equal care to rare and complex diseases across Europe as well as a possible tangible action towards the integration of ERNs into the different European healthcare systems.
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http://dx.doi.org/10.1186/s13023-020-01631-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7734838PMC
December 2020

Social determinants of male partner attendance in women's prevention-of mother-to-child transmission program in Malawi.

BMC Public Health 2020 Nov 30;20(1):1821. Epub 2020 Nov 30.

Institute of Management, Scuola Superiore Sant'Anna, Piazza Martiri Libertà, 56127, Pisa, Italy.

Background: Male partners are rarely present during PMTCT (Prevention-Mother-To-Child-Transmission) services in Sub-Saharan Africa (SSA). Male involvement is increasingly recognised as an important element of women's access to care. This study aims to identify the socio-demographic characteristics, HIV-Knowledge, Attitude and Practice (KAP) among women accompanied and not accompanied by their male partners.

Methods: We included pregnant women enrolled in PMTCT programme between August 2018 and November 2019 in the Southern Region of Malawi. Eligible women were aged 18 years or older, living with a male partner, enrolled for the first time in one of the four selected facilities. We provided a KAP survey to women and their partners attending the facilities. Our primary objective was to assess and analyse the proportion of women who were accompanied by their partner at least once. We applied descriptive statistics and logistic regressions to study the association between being accompanied and explanatory variables.

Results: We enrolled 128 HIV-positive women: 82 (64.1%) were accompanied by their male partners and 46 (35.9%) were alone. In the multivariable model, women's unemployment and owning a means of transport are negatively associated with male attendance (respectively adjusted OR 0.32 [95% CI, 0.11-0.82] and 0.23 [95% CI, 0.07-0.77]), whereas, in the univariable model, high women's level of knowledge of HIV is positively associated with male attendance (OR 2.17 [95% CI, 1.03-4.58]). Level of attitude and practice toward HIV were not significantly associated to our study variable.

Conclusions: Our study shows a high male attendance in Malawi compared to other studies performed in SSA. This study highlights that women's level of knowledge on HIV and their economic condition (employment and owning a means of transport) affects male attendance. Moreover, the study points out that gender power relationships and stringent gender norms play a crucial role thus they should be considered to enhance male involvement.
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http://dx.doi.org/10.1186/s12889-020-09800-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7708238PMC
November 2020

One year in review 2020: economic and organisational aspects in rare and complex connective tissue diseases.

Clin Exp Rheumatol 2020 Nov-Dec;38(6):1037-1045. Epub 2020 Nov 17.

Institute of Management, Scuola Superiore Sant'Anna, Pisa, Italy.

Rare and complex connective tissue diseases (rCTDs) encompass a considerable number of diseases and syndromes and their variability highly impacts on the clinical management, resulting in variable economic and organisational burden that might represent a challenge for healthcare systems. This paper is aimed at providing an overview of the most recent evidence regarding the economic and organisational impact of rCTDs. In particular, this work discusses the most relevant data on specific aspects related to health economics in rCTDs published in 2019.
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December 2020

Shaping the Future of Rare Diseases after a Global Health Emergency: Organisational Points to Consider.

Int J Environ Res Public Health 2020 11 23;17(22). Epub 2020 Nov 23.

Institute of Management, Scuola Superiore Sant'Anna, 56127 Pisa, Italy.

The unexpected outbreak of the COVID-19 disease had significant and enormous repercussions on the healthcare systems, such as the need to reorganise healthcare organisations in order to concentrate resources needed to the care of COVID-19 patients and to respond in general to this health emergency. Due to these challenges, the care of several chronic conditions was in many cases discontinued and patients and healthcare professionals treating these conditions had to cope with this new scenario. This was the case of the world rare diseases (RDs) that had to face this global emergency despite the vulnerability of people with RDs and the well-known need for high expertise required to treat and manage them. The numerous lessons learned so far regarding health emergencies and RDs should represent the basis for the establishment of new healthcare policies and plans aimed at ensuring the preparedness of our health systems in providing appropriate care to people living with RDs in the case of eventual new emergencies. This paper aims at providing pragmatic considerations that might be useful in designing future actions to create or optimise existing organisational models for the care of RDs in case of future emergencies or any other situation that might threaten the provision of routine care. These policies and plans should benefit from the multi-stakeholder RDs networks (such as the European Reference Networks), that should join forces at European, national, and local levels to minimise the economic, organisational, and health-related impact and the negative effects of potential emergencies on the RDs community. In order to design and develop these policies and plans, a decalogue of points to consider were developed to ensure appropriate care for people living with RDs in the case of eventual future health emergencies.
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http://dx.doi.org/10.3390/ijerph17228694DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7700629PMC
November 2020

Determining the cost-effectiveness requirements of an exoskeleton preventing second hip fractures using value of information.

BMC Health Serv Res 2020 Oct 15;20(1):955. Epub 2020 Oct 15.

Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Headington, Oxford, UK.

Background: Falls may lead to hip fractures, which have a detrimental effect on the prognosis of patients as well as a considerable impact on healthcare expenditures. Since a secondary hip fracture (SHF) may lead to even higher costs than primary fractures, the development of innovative services is crucial to limit falls and curb costs in high-risk patients. An early economic evaluation assessed which patients with a second hip fracture could benefit most from an exoskeleton preventing falls and whether its development is feasible.

Methods: The life-course of hip fractured patients presenting with dementia or cardiovascular diseases was simulated using a Markov model relying on the United Kingdom administrative data and complemented by published literature. A group of experts provided the exoskeleton parameters. Secondary analyses included a threshold analysis to identify the exoskeleton requirements (e.g. minimum impact of the exoskeleton on patients' quality of life) leading to a reimbursable incremental cost-effectiveness ratio. Similarly, the uncertainty around these requirements was modelled by varying their standard errors and represented alongside population Expected Value of Perfect Information (EVPI).

Results: Our base-case found the exoskeleton cost-effective when providing a statistically significant reduction in SHF risk. The secondary analyses identified 286 cost-effective combinations of the exoskeleton requirements. The uncertainty around these requirements was explored producing further 22,880 scenarios, which showed that this significant reduction in SHF risk was not necessary to support the exoskeleton adoption in clinical practice. Conversely, a significant improvement in women quality of life was crucial to obtain an acceptable population EVPI regardless of the cost of the exoskeleton.

Conclusions: Our study identified the exoskeleton requisites to be cost-effective and the value of future research. Decision-makers could use our analyses to assess not only whether the exoskeleton could be cost-effective but also how much further research and development of the exoskeleton is worth to be pursued.
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http://dx.doi.org/10.1186/s12913-020-05768-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7565816PMC
October 2020

Clinical practice guidelines adherence, knowledge and awareness in rare and complex connective tissue diseases across Europe: results from the first ERN ReCONNET survey.

RMD Open 2020 08;6(2)

Rheumatology Unit, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy.

Introduction: The European Reference Network (ERN) ReCONNET is the ERN aimed at improving the management of rare and complex connective tissue and musculoskeletal diseases (rCTDs) across the European Union (EU). In the mission of ERN ReCONNET, clinical practice guidelines (CPGs) play a crucial role, representing a valid tool towards the harmonisation of the management of rCTDs while improving effectiveness and quality of care delivered to patients.

Methods: ERN ReCONNET developed two surveys to map the adherence to rCTDs CPGs among healthcare providers and to assess the knowledge and awareness of CPGs for their diseases among patients, family members and caregivers.

Results: The results of the surveys highlighted that healthcare professionals find it useful to apply CPGs in clinical practice (93%), while 62% of them experience difficulties and barriers in the application in their centres. Healthcare professionals also highlighted the need to develop CPGs for all rCTDs and to implement the use of the existing CPGs in clinical practice. On the other hand, patients, families and caregivers are relatively aware of the purpose of CPGs (51%) and 62% of them were aware of the existence of CPGs for their disease. Patient-friendly versions of CPGs and patients' lifestyle guidelines should be systematically developed contributing to the empowerment of patients in the disease management.

Conclusion: ERN ReCONNET is addressing the main issues identified in the results of the survey, promoting practical actions for the local adaptation of CPGs across Europe, improving their routine clinical use and increasing the awareness on CPGs among rCTDs patients, family members and caregivers.
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http://dx.doi.org/10.1136/rmdopen-2020-001344DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7507993PMC
August 2020

Utilisation patterns and clinical impact of the introduction of infliximab-biosimilar in Tuscany, Italy: real world evidence following the recommendation of switching for non-medical reasons.

Clin Exp Rheumatol 2020 Aug 5. Epub 2020 Aug 5.

Pharmacology and Pharmacovigilance Unit, Department of Clinical and Experimental Medicine, and Unit of Adverse Drug Reactions Monitoring, University Hospital of Pisa, Italy.

Objectives: This study was aimed at assessing the impact of a non-medical recommendation on drug-utilisation patterns and clinical outcomes in a central Region of Italy (Tuscany).

Methods: We performed a pre-post study on data collected in Tuscan healthcare administrative databases. We included patients with diagnosis of rheumatoid arthritis, or psoriatic arthritis, or ankylosing spondylitis, or ulcerative colitis, or Crohn's disease, or psoriasis. The first analysis compared patients treated with infliximab on January 1st, 2013 (originator only available) to those on January 1st, 2016 (both originator and biosimilar available). The second analysis compared infliximab-originator users with infliximab-biosimilar ones. Adjusted odds ratios (OR) of persistence on treatment, Emergency Department (ED) admissions, hospitalisations and specialist visits were calculated.

Results: The first analysis included 606 patients and the second 434. In both analyses, we did not observe any significant difference in persistence. In the first analysis, the 2016 infliximab-originator cohort showed a significant association with the risk of having at least one ED admission (OR 1.54, 95% CI 1.02 to 2.31). A significant difference of accessing a specialist visit (more frequently rheumatologic) was observed in the 2016 cohort (OR 1.52, 95% CI 1.05 to 2.20). In the second analysis, the risk of having at least one hospitalisation decreased significantly in switchers to infliximab-biosimilar (OR 0.49, 95% CI 0.26 to 0.96).

Conclusions: Our study showed no relevant changes in the clinical outcomes following the introduction of infliximab-biosimilar. The few observed differences observed can be explained mainly by a selective switching to infliximab-biosimilar in patients with lower burden of disease.
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August 2020

Topic Modeling and User Network Analysis on Twitter during World Lupus Awareness Day.

Int J Environ Res Public Health 2020 07 28;17(15). Epub 2020 Jul 28.

Institute of Management, Scuola Superiore Sant'Anna, 56127 Pisa, Italy.

Twitter is increasingly used by individuals and organizations to broadcast their feelings and practices, providing access to samples of spontaneously expressed opinions on all sorts of themes. Social media offers an additional source of data to unlock information supporting new insights disclosures, particularly for public health purposes. Systemic lupus erythematosus (SLE) is a complex, systemic autoimmune disease that remains a major challenge in therapeutic diagnostic and treatment management. When supporting patients with such a complex disease, sharing information through social media can play an important role in creating better healthcare services. This study explores the nature of topics posted by users and organizations on Twitter during world Lupus day to extract latent topics that occur in tweet texts and to identify what information is most commonly discussed among users. We identified online influencers and opinion leaders who discussed different topics. During this analysis, we found two different types of influencers that employed different narratives about the communities they belong to. Therefore, this study identifies hidden information for healthcare decision-makers and provides a detailed model of the implications for healthcare organizations to detect, understand, and define hidden content behind large collections of text.
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http://dx.doi.org/10.3390/ijerph17155440DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7432829PMC
July 2020

Scoping review and bibliometric analysis of Big Data applications for Medication adherence: an explorative methodological study to enhance consistency in literature.

BMC Health Serv Res 2020 Jul 24;20(1):688. Epub 2020 Jul 24.

Institute of Management, Scuola Superiore Sant'Anna, Pisa, Italy.

Background: Medication adherence has been studied in different settings, with different approaches, and applying different methodologies. Nevertheless, our knowledge and efficacy are quite limited in terms of measuring and evaluating all the variables and components that affect the management of medication adherence regimes as a complex phenomenon. The study aim is mapping the state-of-the-art of medication adherence measurement and assessment methods applied in chronic conditions. Specifically, we are interested in what methods and assessment procedures are currently used to tackle medication adherence. We explore whether Big Data techniques are adopted to improve decision-making procedures regarding patients' adherence, and the possible role of digital technologies in supporting interventions for improving patient adherence and avoiding waste or harm.

Methods: A scoping literature review and bibliometric analysis were used. Arksey and O'Malley's framework was adopted to scope the review process, and a bibliometric analysis was applied to observe the evolution of the scientific literature and identify specific characteristics of the related knowledge domain.

Results: A total of 533 articles were retrieved from the Scopus academic database and selected for the bibliometric analysis. Sixty-one studies were identified and included in the final analysis. The Morisky medication adherence scale (36%) was the most frequently adopted baseline measurement tool, and cardiovascular/hypertension disease, the most investigated illness (38%). Heterogeneous findings emerged from the types of study design and the statistical methodologies used to assess and compare the results.

Conclusions: Our findings reveal a lack of Big Data applications currently deployed to address or measure medication adherence in chronic conditions. Our study proposes a general framework to select the methods, measurements and the corpus of variables in which the treatment regime can be analyzed.
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http://dx.doi.org/10.1186/s12913-020-05544-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7379348PMC
July 2020

Translation, cultural adaptation and validation of the Italian version of the Brief Index of Lupus Damage: the BILDit.

Lupus 2020 Sep 13;29(10):1198-1205. Epub 2020 Jul 13.

Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.

Objectives: The Brief Index of Lupus Damage (BILD) is an instrument of self-evaluation of organ damage for systemic lupus erythematosus (SLE) patients. The objectives of this study were the translation, cultural adaptation and validation of the Italian version of the BILD (BILDit).

Methods: The process of translation and cultural adaptation followed published guidelines. The BILDit was pretested in a pilot study with 30 SLE patients in order to evaluate acceptability, reliability, comprehension and feasibility, and then validated in consecutive SLE patients attending our clinic.

Results: A total of 167 SLE patients were enrolled. In the pilot study, the BILDit demonstrated good acceptability, feasibility and comprehensibility and a very high degree of reliability (Cronbach's α = 1). In the validation cohort, the BILDit showed a significant positive correlation with the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI; ρ = 0.69;  < 0.001). Analysing the item-by-item correlation between the BILDit and the SDI, a good correlation ( < 0.001) was found for 73.1% of the items. In the multivariate analysis, the BILDit showed a significant positive correlation with age and disease duration ( < 0.01).

Conclusions: The BILDit seems to be an acceptable and reliable instrument for patient self-evaluation of disease damage, with a good correlation with the SDI. It can be considered as a screening tool for the evaluation of organ damage starting from the patient's perceptive.
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http://dx.doi.org/10.1177/0961203320940012DOI Listing
September 2020

The COVID-19 outbreak: From "black swan" to global challenges and opportunities.

Pulmonology 2020 May - Jun;26(3):117-118. Epub 2020 Apr 11.

Istituti Clinici Scientifici Maugeri IRCCS, Istituto di Montescano, Italy.

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http://dx.doi.org/10.1016/j.pulmoe.2020.03.002DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7151362PMC
May 2020

The effectiveness of interventions to involve men living with HIV positive pregnant women in low-income countries: a systematic review of the literature.

BMC Health Serv Res 2019 Dec 9;19(1):943. Epub 2019 Dec 9.

Institute of Management, Scuola Superiore Sant'Anna, Piazza Martiri della Libertà, 33, 56127, Pisa, Italy.

Background: Male involvement (MI) along the continuum of HIV healthcare services has been promoted as a critical intervention in low-income countries and represents one of the reasons for dropout and low retention of women along the cascade of care. The present review aims to identify interventions adopted to improve MI across Antenatal Clinics (ANCs).

Methods: For this systematic review, we searched electronic databases, including Scopus, PubMed, Web of Science (from 2008 to 2018) in English language. We included all interventions explicitly aimed at involving partners in pregnant women's HIV continuum of care and we excluded studies performed in developed countries, not involving pregnant women. We followed the PRISMA checklist.

Results: We identified a total of 1694 records and excluded 1651 after duplicates were removed and abstract eligibility assessments were performed. Forty-three full-text articles were screened, but only 12 studies were included. Recurrent intermediate outcomes were antenatal partner attendance rate and male HIV testing. We subdivided articles according to the type of intervention: single intervention (7) and multiple interventions (5). Among single interventions, two studies evaluated the use of an invitation letter sent via women to encourage male attendance to the ANC. Four Randomized Controlled Trials (RCTs) compared the invitation card (standard of care, SC) to word of mouth, information letter, home visit and invitation card plus partner tracing. The partner attendance rate was lower in SC than in the intervention arm in three RCTs: information letter (14.2% vs 16.2%), home-visit (39% vs 87%) and invitation card plus partner tracing (52% vs 74%). Home visit strategies seemed the most effective. One study evaluated words of encouragement adopted to trigger women to invite their partners. Among multiple interventions, the most effective strategies in terms of male attendance included health promotion through education and healthcare worker development. These interventions were more likely to be effective in promoting MI than single interventions.

Conclusions: From the review emerges the importance of male involvement in HIV cascade for pregnant women in countries with a significant HIV incidence and the need to define more precise indicators for measuring MI.
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http://dx.doi.org/10.1186/s12913-019-4689-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6902537PMC
December 2019

Correction to: Cost‑effectiveness analysis of stand‑alone or combined non‑invasive imaging tests for the diagnosis of stable coronary artery disease: results from the EVINCI study.

Eur J Health Econ 2019 Dec;20(9):1451

Institute of Management, Scuola Superiore Sant'Anna, Piazza Martiri della Libertà n. 33, 56127, Pisa, Italy.

In the Published article, the value in the abstract has been published incorrectly. The correct abstract section is as follows.
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http://dx.doi.org/10.1007/s10198-019-01128-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6943386PMC
December 2019

Cost-effectiveness analysis of stand-alone or combined non-invasive imaging tests for the diagnosis of stable coronary artery disease: results from the EVINCI study.

Eur J Health Econ 2019 Dec 13;20(9):1437-1449. Epub 2019 Aug 13.

Institute of Management, Scuola Superiore Sant'Anna, Piazza Martiri della Libertà n. 33, 56127, Pisa, Italy.

Aim: This study aimed at evaluating the cost-effectiveness of different non-invasive imaging-guided strategies for the diagnosis of obstructive coronary artery disease (CAD) in a European population of patients from the Evaluation of Integrated Cardiac Imaging in Ischemic Heart Disease (EVINCI) study.

Methods And Results: Cost-effectiveness analysis was performed in 350 patients (209 males, mean age 59 ± 9 years) with symptoms of suspected stable CAD undergoing computed tomography coronary angiography (CTCA) and at least one cardiac imaging stress-test prior to invasive coronary angiography (ICA) and in whom imaging exams were analysed at dedicated core laboratories. Stand-alone stress-tests or combined non-invasive strategies, when the first exam was uncertain, were compared. The diagnostic end-point was obstructive CAD defined as > 50% stenosis at quantitative ICA in the left main or at least one major coronary vessel. Effectiveness was defined as the percentage of correct diagnosis (cd) and costs were calculated using country-specific reimbursements. Incremental cost-effectiveness ratios (ICERs) were obtained using per-patient data and considering "no-imaging" as reference. The overall prevalence of obstructive CAD was 28%. Strategies combining CTCA followed by stress ECHO, SPECT, PET, or stress CMR followed by CTCA, were all cost-effective. ICERs values indicated cost saving from - 969€/cd for CMR-CTCA to - 1490€/cd for CTCA-PET, - 3092€/cd for CTCA-SPECT and - 3776€/cd for CTCA-ECHO. Similarly when considering early revascularization as effectiveness measure.

Conclusion: In patients with suspected stable CAD and low prevalence of disease, combined non-invasive strategies with CTCA and stress-imaging are cost-effective as gatekeepers to ICA and to select candidates for early revascularization.
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http://dx.doi.org/10.1007/s10198-019-01096-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6856023PMC
December 2019

Rare diseases under different levels of economic analysis: current activities, challenges and perspectives.

RMD Open 2018 12;4(Suppl 1):e000794. Epub 2018 Nov 12.

Institute of Management, Scuola Superiore Sant'Anna, Pisa, Italy.

Rare diseases imply clinical and economic burden as well as a significant challenge for health systems. One relevant objective of the activities planned within the European Reference Network on Rare and Complex Connective Tissue and Musculoskeletal Diseases (ERN ReCONNET) is to address the economic dimensions of rare diseases to identify, develop and suggest strategies to improve research and patients' access to orphan drugs (ODs) and highly specialised health technologies. This paper presents a preliminary review of the existing policies on rare diseases in the countries of the Network members. It also introduces and discusses the theme of of rare diseases and of existing or new treatments for rare diseases. To obtain a preliminary overview aiming at defining the state of the art of rare diseases policies and initiatives in ERN ReCONNET countries, we collected and analysed the rare diseases national plans of all the eight countries of the ERN ReCONNET participants. The preliminary overview that has been performed showed that in all the ERN ReCONNET countries are in place national plans for rare diseases; however, heterogeneity exists in the reimbursement of ODs, direct provision by the healthcare system, involvement of patients' associations in decision making and implementation of clinical practice guidelines.
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http://dx.doi.org/10.1136/rmdopen-2018-000794DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6241967PMC
November 2018