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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
Background
Robotic-assisted surgery by the da Vinci Si appears to benefit rectal cancer surgery in selected patients, but still has some limitations, one of which is its high costs. Preliminary ...studies have indicated that the use of the new da Vinci Xi provides some added advantages, but their impact on cost is unknown. The aim of the present study is to compare surgical outcomes and costs of rectal cancer resection by the two platforms, in a single surgeon’s experience.
Methods
From April 2010 to April 2017, 90 robotic rectal resections were performed, with either the da Vinci Si (Si-RobTME) or the da Vinci Xi (Xi-RobTME). Based on CUSUM analysis, two comparable groups of 40 consecutive Si-RobTME and 40 consecutive Xi-RobTME were obtained from the prospectively collected database and used for the present retrospective comparative study. Data costs were analysed based on the level of experience on the proficiency–gain curve (p–g curve) by the surgeon with each platform.
Results
In both groups, two homogeneous phases of the p–g curve were identified: Si1 and Xi1: cases 1–19, Si2 and Xi2: cases 20–40. A significantly higher number of full RAS operations were achieved in the Xi-RobTME group (
p
< 0.001). A statistically significant reduction in operating time (OT) during Si2 and Xi2 phase was observed (
p
< 0.001), accompanied by reduced overall variable costs (OVC), personnel costs (PC) and consumable costs (CC) (
p
< 0.001). All costs were lower in the Xi2 phase compared to Si2 phase: OT 265 versus 290 min (
p
= 0.052); OVC 7983 versus 10231.9 (
p
= 0.009); PC 1151.6 versus 1260.2 (
p
= 0.052), CC 3464.4 versus 3869.7 (
p
< 0.001).
Conclusions
Our experience confirms a significant reduction of costs with increasing surgeon’s experience with both platforms. However, the economic gain was higher with the Xi with shorter OT, reduced PC and CC, in addition to a significantly larger number of cases performed by the fully robotic approach.
Congenital haemophilia A (HA) is a rare, inherited, life-long bleeding disorder characterised by prolonged or spontaneous bleeding due to the lack of clotting factor VIII (FVIII) in the body. ...Treatment for HA involves FVIII replacement therapy and poses great economic burden to National Health Systems and to society. Availability of novel products as extended half-life clotting factor products might change treatment approches and their economic evaluation is essential for an informed treatment choice. Accordingly the objective of the present work is to analyse the economic impact of using efmoroctocog alfa (recombinant factor VIII-Fc fusion protein, rFVIIIFc) for the treatment of children and adults with severe congenital haemophilia A (HA).
A budget impact analysis was performed to estimate the economic impact of the introduction of rFVIIIFc in the market-mix of products for the treatment of HA. The analysis condidered a 3-year time horizon and the Italian National Health System (INHS) perspective. The model estimated drug costs associated with the treatment of HA in the current scenario - representing the marketplace forecast for the time period of interest assuming that rFVIIFc is not introduced - and a new scenario, assuming that rFVIIIFc is available in the market. The size of the target population was calculated using epidemiological national data. Univariate one-way sensitivity analyses and scenario analyses were performed.
Overall 3-year costs of treating the HA population in the current scenario were 555,277,691 Euro for the INHS. With the introduction of rFVIIIFc, the costs were reduced to 541,897,466 Euro suggesting potential savings to the INHS of 13,380,255 Euro. Results were consistent at variation of most of the model's parameters; only in case of lower dosage of conventional products and higher dosage of rFVIIIFc, costs for the INHS increased, in both cases, of about 20 million Euro.
The use of rFVIIIFc for the treatment of HA has been recently approved by the Italian Medicines Agency (AIFA) and this is the first study estimating the financial impact of this new therapeutic alternative in the Italian context. The analysis suggests that rFVIIIFc use does not result in higher expenditure for the INHS.
To determine diagnostic performance of non-invasive tests using invasive fractional flow reserve (FFR) as reference standard for coronary artery disease (CAD).
Medline, Embase, and citations of ...articles, guidelines, and reviews for studies were used to compare non-invasive tests with invasive FFR for suspected CAD published through March 2017.
Seventy-seven studies met inclusion criteria. The diagnostic test with the highest sensitivity to detect a functionally significant coronary lesion was coronary computed tomography (CT) angiography 88%(85%–90%), followed by FFR derived from coronary CT angiography (FFRCT) 85%(81%–88%), positron emission tomography (PET) 85%(82%–88%), stress cardiac magnetic resonance (stress CMR) 81%(79%–84%), stress myocardial CT perfusion combined with coronary CT angiography 79%(74%–83%), stress myocardial CT perfusion 77%(73%–80%), stress echocardiography (Echo) 72%(64%–78%) and stress single-photon emission computed tomography (SPECT) 64%(60%–68%). Specificity to rule out CAD was highest for stress myocardial CT perfusion added to coronary CT angiography 91%(88%–93%), stress CMR 91%(90%–93%), and PET 87%(86%–89%).
A negative coronary CT angiography has a higher test performance than other index tests to exclude clinically-important CAD. A positive stress myocardial CT perfusion added to coronary CT angiography, stress cardiac MR, and PET have a higher test performance to identify patients requiring invasive coronary artery evaluation.
•CTCA is an excellent tool to rule out obstructive CAD.•FFRCT or stress CTP improve the post-test likelihood of significant CAD.•PET, CMR, and CTCA combined with CTP showed the highest positive likelihood ratio.
Validation of algorithms for selecting patients from healthcare administrative databases (HAD) is recommended. This PATHFINDER study section is aimed at testing algorithms to select rheumatoid ...arthritis (RA) patients from Tuscan HAD (THAD) and assessing RA diagnosis time interval between the medical chart date and that of THAD. A population was extracted from THAD. The information of the medical charts at the Rheumatology Unit of Pisa University Hospital represented the reference. We included first ever users of biologic disease modifying anti-rheumatic drugs (bDMARDs) between 2014 and 2016 (index date) with at least a specialist visit at the Rheumatology Unit of the Pisa University Hospital recorded from 2013 to the index date. Out of these, we tested four index tests (algorithms): (1) RA according to hospital discharge records or emergency department admissions (ICD-9 code, 714*); (2) RA according to exemption code from co-payment (006); (3) RA according to hospital discharge records or emergency department admissions AND RA according to exemption code from co-payment; (4) RA according to hospital discharge records or emergency department admissions OR RA according to exemption code from co-payment. We estimated sensitivity, specificity, positive and negative predicted values (PPV and NPV) with 95% confidence interval (95% CI) and the RA diagnosis median time interval (interquartile range, IQR). Two sensitivity analyses were performed. Among 277 reference patients, 103 had RA. The fourth algorithm identified 96 true RA patients, PPV 0.78 (95% CI 0.70-0.85), sensitivity 0.93 (95% CI 0.86-0.97), specificity 0.84 (95% CI 0.78-0.90), and NPV 0.95 (95% CI 0.91-0.98). The sensitivity analyses confirmed performance. The time measured between the actual RA diagnosis date recorded in medical charts and that assumed in THAD was 2.2 years (IQR 0.5-8.4). In conclusion, this validation showed the fourth algorithm as the best. The time interval elapsed between the actual RA diagnosis date in medical charts and that extrapolated from THAD has to be considered in the design of future studies.
Abstract Objectives This study sought to determine the ischemia threshold and additional prognostic factors that identify patients for safe deferral from revascularizations in a large cohort of ...all-comer patients with known or suspected coronary artery disease (CAD). Background Stress-perfusion cardiac magnetic resonance (CMR) is increasingly used in daily practice for ischemia detection. However, there is insufficient evidence about the ischemia burden that identifies patients who benefit from revascularization versus those with a good prognosis who receive drugs only. Methods All patients with known or suspected CAD referred to stress-perfusion CMR for myocardial ischemia assessment were prospectively enrolled. The CMR examination included standard functional adenosine stress first-pass perfusion (gadobutrol 0.1 mmol/kg Gadovist, Bayer AG, Zurich, Switzerland) and late gadolinium enhancement (LGE) acquisitions. Presence of ischemia and ischemia burden (number of ischemic segments on a 16-segment model), and of scar and scar burden (number and transmurality of scar segments in a 17-segment model) were assessed. The primary endpoint was a composite of cardiac death, nonfatal myocardial infarction (MI), and late coronary revascularization (>90 days post-CMR); the secondary endpoint was a composite of cardiac death and nonfatal MI. Results During a follow-up of 2.5 ± 1.0 years, 86 and 32 of 1,024 patients (1,103 screened patients) experienced the primary and secondary endpoints, respectively. On Kaplan-Meier curves for the primary and secondary endpoints, patients without ischemia had excellent outcomes that did not differ from patients with <1.5 ischemic segments. In multivariate Cox regression analyses of the entire population and of the subgroups, ischemia burden (threshold: ≥1.5 ischemic segments) was consistently the strongest predictor of the primary and secondary endpoints with hazard ratios (HRs) of 7.42 to 8.72 (p < 0.001), whereas age (≥67 years), left ventricular ejection fraction (≤40%), and scar burden (LGE score ≥0.03) contributed significantly, but to a lesser extent, in all models with HRs of 2.01 to 3.48, 1.75 to 1.96, and 1.66 to 1.76, respectively. Conclusions In a large all-comer patient cohort with known and suspected CAD, an ischemia burden of ≥1.5 ischemic segments on stress-perfusion CMR was the strongest predictor of the primary and secondary endpoints. Patients with zero or 1 ischemic segment can be safely deferred from revascularizations.
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.
The addition of myocardial perfusion (MP) imaging during dipyridamole real-time contrast echocardiography improves the sensitivity to detect coronary artery disease, but its prognostic value to ...predict hard cardiac events in large numbers of patients with known or suspected coronary artery disease remains unknown.
We studied 1252 patients with the use of dipyridamole real-time contrast echocardiography and followed them for a median of 25 months. The prognostic value of MP imaging regarding death and nonfatal myocardial infarction was determined and related to wall motion (WM), clinical risk factors, and rest ejection fraction by the use of Cox proportional-hazards models, C index, and risk reclassification analysis. A total of 59 hard events (4.7%) occurred during the follow-up (24 deaths, 35 myocardial infarctions). The 2-year event-free survival was 97.9% in patients with normal MP and WM, 91.9% with isolated reversible MP defects but normal WM, and 67.4% with both reversible MP and WM abnormalities (P<0.001). By multivariate analysis the independent predictors of events were age (hazard ratio 1.05, 95% confidence interval CI, 1.02-1.08), sex (hazard ratio, 2.36; 95% CI, 1.32-4.23), reversible MP defects (hazard ratio, 3.88; 95% CI, 1.83-8.21), and reversible WM abnormalities with reversible MP defects (hazard ratio, 4.51; 95% CI, 2.25-9.07). Reversible MP defects added incremental predictive value and reclassification benefit over WM response and clinical factors (P=0.001).
MP imaging using real-time perfusion echocardiography during dipyridamole real-time contrast echocardiography provides independent, incremental prognostic information regarding hard cardiac events in patients with known or suspected coronary artery disease. Patients with normal MP responses have better outcome than patients with normal WM; patients with both reversible WM and MP abnormalities have the worst outcome.
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