Administrative healthcare databases are useful and inexpensive tools that can provide a comprehensive assessment of the burden of diseases in terms of major outcomes, such as mortality, hospital ...readmissions, and use of healthcare resources. However, a crucial issue is the reliability of information gathered. The aim of this study was to validate ICD-9 codes for several major cardiovascular conditions, i.e., acute myocardial infarction (AMI), atrial fibrillation/flutter (AF), and heart failure (HF), in order to use them for epidemiological, outcome, and health services research.
Data from the centralised administrative database of the Umbria Region (890,000 residents, located in Central Italy) were considered. Patients with a first hospital discharge for AMI, AF/flutter, and HF, between 2012 and 2014, were identified using ICD-9-CM codes in primary position. A sample of cases and non-cases was randomly selected, and the corresponding medical charts reviewed by specifically trained investigators. For each disease, case ascertainment was based on all clinical, laboratory, and instrumental examinations available in medical charts. Sensitivity, specificity, and predictive values with 95% confidence intervals (CIs), were calculated.
We reviewed 458 medical charts, 128 for AMI, 127 for AF/flutter, 127 for HF, and 76 of non-cases for each condition. Diagnostic accuracy measures of the original discharge diagnosis were as follows. AMI: sensitivity 98% (95% CI, 94-100%), specificity 91% (95% CI, 83-97%), positive predictive value (PPV) 95% (95% CI, 89-98%), negative predictive value (NPV) 97% (95% CI, 91-100%). AF/flutter: sensitivity 95% (95% CI, 90-98%), specificity 95% (95% CI, 87-99%), PPV 97% (95% CI, 92-99%), NPV 92% (95% CI, 84-97%). HF: sensitivity 96% (95% CI, 91-99%), specificity 90% (95% CI, 81-96%), PPV 94% (95% CI, 88-97%), NPV 93% (95% CI, 85-98%).
The case ascertainment for AMI, AF and flutter, and HF, showed a high level of accuracy (≥ 90%). The healthcare administrative database of the Umbria Region can be confidently used for epidemiological, outcome, and health services research.
This systematic review aims to update the evidence on Duchenne muscular dystrophy (DMD) in Italy, describing the epidemiology, quality of life (QoL) of patients and caregivers, treatment adherence, ...and economic impact of DMD.
Systematic searches were conducted in PubMed, Embase and Web of Science up to January 2023. Literature selection process, data extraction and quality assessment were performed by two independent reviewers. Study protocol was registered in PROSPERO (CRD42021245196).
Thirteen studies were included. The prevalence of DMD in the general population is 1.7-3.4 cases per 100,000, while the birth prevalence is 21.7-28.2 per 100,000 live male births. The QoL of DMD patients and caregivers is lower than that of healthy subjects, and the burden for caregivers of DMD children is higher than that of caregivers of children with other neuromuscular disorders. The compliance of real-world DMD care to clinical guidelines recommendations in Italy is lower than in other European countries. The annual cost of illness for DMD in Italy is € 35,000-46,000 per capita while, adding intangible costs, the total cost amounts to € 70,000.
Although it is a rare disease, DMD represents a significant burden in terms of quality of life of patients and their caregivers, and economic impact.
Bivalves are filter-feeding animals able to accumulate contaminants and microorganisms, either of marine or terrestrial origin. The aim of this study was to describe the prevalence of antimicrobial ...resistance (AMR) in bacterial isolates from bivalves using a systematic review of the literature. Comprehensive searches of MEDLINE, EMBASE, and Web of Science were carried out, based upon a registered protocol (PROSPERO), and following the preferred Reporting Items for Systematic reviews and Meta-Analysis (PRISMA) guidelines. The methodological quality of the included studies was assessed using a modified Hoy checklist. Meta-analyses of prevalence were carried out using random-effects models. In total, 103 articles were selected from 1,280 records and were included in the final analysis. The studies were from Asia (
= 54), Europe (
= 27), South and North America (
= 10 and
= 6, respectively), Africa (
= 2), Oceania (
= 1), and multicentre and intercontinental (
= 3). The meta-analysis of multiple antibiotic resistance (MAR) index revealed
spp. as the genus with the highest prevalence of AMR (37%), followed by
spp. (34%),
spp. (18%), and
(15%). Resistance to third/fourth/fifth generation cephalosporins and fluoroquinolones, two highest priority, critically important antimicrobials (HPCIA), was recorded in approximately 10% of
.
isolates. Resistance to carbapenems was very low (<2%) in
spp. and in
.
, but was found in 5% of
spp. and in more than a third of
spp. isolates. In aquatic bacteria, resistance to carbapenems was higher in Asian than in European isolates. Our study shows the presence of antibiotic resistant bacteria (ARB), including bacteria resistant to HPCIA, in marine bivalves, posing a risk for consumers.
This systematic review aims to describe 1) the epidemiology of the diseases indicated for treatment with growth hormone (GH) in Italy; 2) the adherence to the GH treatment in Italy and factors ...associated with non-adherence; 3) the economic impact of GH treatment in Italy; 4) the quality of life of patients treated with GH and their caregivers in Italy.
Systematic literature searches were performed in PubMed, Embase and Web of Science from January 2010 to March 2021. Literature selection process, data extraction and quality assessment were performed by two independent reviewers. Study protocol has been registered in PROSPERO (CRD42021240455).
We included 25 studies in the qualitative synthesis. The estimated prevalence of growth hormone deficiency (GHD) was 1/4,000-10,000 in the general population of children; the prevalence of Short Stature HOmeoboX Containing gene deficiency (SHOX-D) was 1/1,000-2,000 in the general population of children; the birth prevalence of Turner syndrome was 1/2,500; the birth prevalence of Prader-Willi syndrome (PWS) was 1/15,000. Treatment adherence was suboptimal, with a range of non-adherent patients of 10-30%. The main reasons for suboptimal adherence were forgetfulness, being away from home, pain/discomfort caused by the injection. Economic studies reported a total cost for a complete multi-year course of GH treatment of almost 100,000 euros. A study showed that drug wastage can amount up to 15% of consumption, and that in some Italian regions there could be a considerable over- or under-prescribing. In general, patients and caregivers considered the GH treatment acceptable. There was a general satisfaction among patients with regard to social and school life and GH treatment outcomes, while there was a certain level of intolerance to GH treatment among adolescents. Studies on PWS patients and their caregivers showed a lower quality of life compared to the general population, and that social stigma persists.
Growth failure conditions with approved GH treatment in Italy constitute a significant burden of disease in clinical, social, and economic terms. GH treatment is generally considered acceptable by patients and caregivers. The total cost of the GH treatment is considerable; there are margins for improving efficiency, by increasing adherence, reducing drug wastage and promoting prescriptive appropriateness.
We evaluated the efficacy, safety, adherence, quality of life (QoL) and cost-effectiveness of long-acting growth hormone (LAGH) vs daily growth hormone (GH) preparations in the treatment of growth ...hormone deficiency (GHD) in children. Systematic searches were performed in PubMed, Embase and Web of Science up to July 2022 on randomized and non-randomized studies involving children with GHD receiving LAGH as compared to daily GH. Meta-analyses for efficacy and safety were performed comparing different LAGH/daily GH formulations. From the initial 1393 records, we included 16 studies for efficacy and safety, 8 studies for adherence and 2 studies for QoL. No studies reporting cost-effectiveness were found. Pooled mean differences of mean annualized height velocity (cm/year) showed no difference between LAGH and daily GH: Eutropin Plus® vs Eutropin® − 0.14 (−0.43, 0.15), Eutropin Plus® vs Genotropin® − 0.74 (−1.83, 0.34), Jintrolong® vs Jintropin AQ® 0.05 (−0.54, 0.65), Somatrogon vs Genotropin® − 1.40 (−2.91, 0.10), TransCon vs Genotropin® 0.93 (0.26, 1.61). Also, other efficacy and safety outcomes, QoL and adherence were comparable for LAGH and daily GH.
Our results showed that, although most of the included studies had some concerns for risk of bias, regarding efficacy and safety all the LAGH formulations were similar to daily GH. Future high quality studies are needed to confirm these data. Adherence and QoL should be addressed from real-world data studies for both the mid and long term and in a larger population. Cost-effectiveness studies are needed to measure the economic impact of LAGH from the healthcare payer’s perspective.
Display omitted
•Therapy with Long-acting GH preparations (LAGH) reduces the frequency of administration of GH.•Pooled mean differences of mean annualized height velocity showed no difference between LAGH and daily GH.•Safety outcomes were comparable for LAGH and daily GH.•Quality of life in children taking LAGH was similar to that of children using daily GH.•As is observed in RCTs, adherence was similarly high with daily GH and weekly GH.
ObjectiveTo assess the effectiveness of lasers (at sub-ablative parameters) in reducing caries incidence compared with traditional prophylactic interventions (TPIs) when used alone or together with ...other TPIs such as pits and fissures sealant or fluoride gels or varnishes.DesignA systematic review. Data sources include Medline (via PubMed), Embase, Web of Science and the Cochrane Library (December 2019).Eligibility criteriaOnly randomised trials (RCTs) and controlled clinical trials (CCTs) dealing with prophylactic lasers use (vs TPI or untreated teeth) were considered as eligible. We excluded in vitro and ex vivo studies.Data extractionEligible studies were selected and data extracted independently by two reviewers. Risk of bias was assessed adopting the Cochrane Risk of Bias tool. Data on caries incidence, sealant retention, fluoride uptake, adverse events, treatment duration, patients’ discomfort and cost-effectiveness ratio was extracted.Data analysisExtracted data were presented narratively due to the heterogeneity of included studies.ResultsSeven RCTs and two CCTs, all with an evident risk of bias, met inclusion criteria, pooling together 269 individuals and 1628 teeth. CO2, neodymium-doped yttrium aluminium garnet, erbium-doped yttrium aluminum garnet (Er:YAG), erbium, chromium: yttrium scandium gallium garnet (Er,Cr:YSGG) and Argon lasers were used. In the permanent dentition, lasers only when used in combination with TPIs were effective in reducing caries when compared with untreated teeth (risk ratio (RR)=0.44 (0.20–0.97); Er:YAG laser) or with TPIs used alone (RR=0.39 (0.22–0.71); CO2 laser). Moreover, Argon laser significantly improved the fluoride uptake into the enamel surfaces (ANalysis Of VAriance (ANOVA) tests: 95%, p<0.0001). Likewise, sealant retention improved when acid etching was performed on previously irradiated enamel fissures by CO2 laser (RR=0.63 (0.38–1.04)) or Er:YAG laser (RR=0.54 (95% CI: 0.34 to 0.87)). In addition, laser resulted safe and well tolerated by patients.ConclusionDespite some positive indications, an inadequate level of evidence was found in the included studies concerning the lasers’ effectiveness in preventing caries. Further studies with a higher methodological quality level are required.
Validation of administrative databases for cerebrovascular diseases is crucial for epidemiological, outcome, and health services research. The aim of this study was to validate ICD-9 codes for ...hemorrhagic or ischemic stroke in administrative databases, to use them for a comprehensive assessment of the burden of disease in terms of major outcomes, such as mortality, hospital readmissions, and use of healthcare resources.
We considered the hospital discharge abstract database of the Umbria Region (890,000 residents). Source population was represented by patients aged >18 discharged from hospital with a diagnosis of hemorrhagic or ischemic stroke between 2012 and 2014 using ICD-9-CM codes in primary position. We randomly selected and reviewed medical charts of cases and non-cases from hospitals. For case ascertainment we considered symptoms and instrumental tests reported in the medical charts. Diagnostic accuracy measures were computed using 2x2 tables.
We reviewed 767 medical charts for cases and 78 charts for non-cases. Diagnostic accuracy measures were: subarachnoid hemorrhage: sensitivity (SE) 100% (95% CI: 97%-100%), specificity (SP) 96% (90-99), positive predictive value (PPV) 98% (93-100), negative predictive value (NPV) 100% (95-100); intracerebral hemorrhage: SE 100% (97-100), SP 98% (91-100), PPV 98% (94-100), NPV 100% (95-100); other and unspecified intracranial hemorrhage: SE 100% (97-100), SP 96% (90-99), PPV 98% (93-100), NPV 100% (95-100); ischemic stroke due to occlusion and stenosis of precerebral arteries: SE 99% (94-100), SP 66 (57-75), PPV 70% (61-77), NPV 99% (93-100); occlusion of cerebral arteries: SE 100% (97-100), SP 87% (78-93), PPV 91% (84-95), NPV 100% (95-100); acute, but ill-defined, cerebrovascular disease: SE 100% (97-100), SP 78% (69-86), PPV % 83 (75-89), NPV 100% (95-100).
Case ascertainment for both ischemic and hemorrhagic stroke showed good or high levels of accuracy within the regional healthcare databases in Umbria. This database can confidently be employed for epidemiological, outcome, and health services research related to any type of stroke.
Background Peptic ulcer is a widespread disease, frequently complicated by perforation and bleeding. Administrative databases are useful tool to perform epidemiological and drug utilization studies, ...but they need a validation process based on a comparison with the original data contained in the medical charts. Our aim was to evaluate the accuracy of the ICD-9 codes in identifying patients with peptic ulcer and gastrointestinal hemorrhage in the regional administrative database of Umbria. Methods The index test of our study was the hospital discharge abstract database of the Umbria region (Italy), while the reference standard was the clinical information collected in the medical charts. The study population were adult patients with a hospital discharge for peptic ulcer or gastrointestinal hemorrhage in the period 2012-2014. A random sample of cases and non-cases was selected and the corresponding medical charts were reviewed. Cases of peptic ulcer were confirmed based on endoscopy, radiology, and surgery, while adjudication of gastrointestinal hemorrhage was based on presence of hematemesis, melena, and rectal bleeding. Results Overall, we reviewed 445 clinical charts of cases and 80 clinical charts of non-cases. The diagnostic accuracy results were: code 531 (gastric ulcer), sensitivity and NPV 98%, specificity 88%, and PPV 91%; code 532 (duodenal ulcer), sensitivity and NPV 100%, specificity and PPV 98%; code 534 (gastrojejunal ulcer), sensitivity and NPV 100%, specificity 70%, and PPV 45%; code 578 (gastrointestinal hemorrhage), sensitivity 96%, specificity 90%, PPV and NPV 94%. Conclusions Our results showed a high level of diagnostic accuracy for most of the codes considered. The ICD-9 code 534 of gastrojejunal ulcer had a lower level of specificity and PPV due to false positives, being mainly misclassifications for coding errors. These validated codes can be used for future epidemiological studies and for health services research.
Our study's objective was to assess the incidence trends and healthcare resource utilization of hospitalizations for Tick-Borne Encephalitis (TBE) and associated costs in Italy in order to improve ...public awareness and preventive measures.
This retrospective observational study was based on the Italian Ministry of Health's Hospital Discharge Record (HDR) database. Data were gathered across Italy from 2015 to 2019, selecting hospitalizations with ICD-9 code 063 related to TBE, both in primary and secondary diagnoses. For each year, we collected the following variables: number of hospitalizations, hospitalization rate, mortality rate, mean length of hospital stay, hospital ward, and cost of hospitalization.
There were a total of 237 hospitalizations from 2015 to 2019; 62 % of those were male. The lowest number of TBE hospitalizations was in 2015 (21 cases, corresponding to 0.35 per million inhabitants), the highest in 2019 (64 cases, 1.04 per million inhabitants). The summer months saw a greater than average number of hospitalizations. For the years analyzed, the cumulative number of cases peaked in June (54 cases), July (46 cases), and August (35 cases). There were only two deaths registered in our study sample. TBE cases were mostly localized in the North-Eastern regions of Italy. TBE incidence during the study period in the most affected areas were: Autonomous Province of Trento, ranging from 11.2 to 42.3 per million inhabitants, Autonomous Province of South Tyrol, from 0 to 21.1 per million inhabitants, and Veneto Region, from 2.6 to 4.5 per million inhabitants. In the study period, the average length of hospital stay was largely stable ranging from 10.6 days to 12.8 days, with related costs ranging from 5,813.7 € to 7,352.5 €.
According to our data, the majority of TBE hospitalizations occur in North-East Italy with an increasing trend over the analyzed period. Even though Italy has fewer TBE cases than other neighboring European countries, the health and economic impact can be high in the affected areas.
Abstract Background Respiratory syncytial virus (RSV) affects 60–80% of children below 1 year and it’s the first cause of acute bronchiolitis. The aim of this study was to assess the trend and ...characteristics of hospitalizations for RSV infections in Italy. Methods This is a retrospective study based on the Italian Hospital Discharge Record (HDR) database. We analysed HDRs from June 2015 to May 2019, considering two groups of infants: Group 1 had a confirmed diagnosis of RSV; Group 2 had a diagnosis of acute bronchiolitis not RSV-coded. Results There were 67,746 overall hospitalizations (40.1% Group 1, and 59.9% Group 2). Hospitalization rate increased for Group 1 from 125 to 178 per 10,000 infants (+ 42.4%), and for Group 2 from 210 to 234 per 10,000 (+ 11.4%). The mean hospitalization length was 6.3 days in Group 1, longer than Group 2 (+ 1.0 day). A further analysis revealed that infants with heart disease or born premature had longer mean hospital stay compared to infants without risk factors (10.7 days versus 6.1 days, p < 0.0001; 34.0 days versus 6.1 days, p < 0.0001, respectively). Group 1 required more critical care (oxygen therapy and/or mechanical ventilation) than Group 2. We found that, in proportion to hospital admissions in pediatric and general hospitals, RSV was more frequently diagnosed in the first ones. The mean hospitalization cost increased for Group 1 (from € 2,483 to € 2,617) and Group 2 (from € 2,007 to € 2,180). Conclusions Our results confirmed that RSV pulmonary disease in infants is seasonal and often requires hospitalization. Our study suggested that RSV is responsible for an increasing hospitalization rate and related costs during the study period.
PDF
