1,523 research outputs found
A combinatorial approach to electronic healthcare records in pharmacoepidemiology
No full textThere is a need to know when multi-country observational studies are useful and how they should be performed and interpreted, because there are no well-established methods to deal with the combination of data from several independent electronic healthcare registries. The overall aim of this thesis was to explore the value of using data from multiple countries when estimating the risk of fractures for patients with multiple sclerosis (MS) and the risk of fractures for patients exposed to thiazolidinediones (TZDs). Data were retrieved from three different electronic healthcare registries: the British General Practice Research Database (GPRD), the Dutch PHARMO Record Linkage System (RLS), and the Danish National Health Registers linked to the Danish MS Registry. Our studies of MS and fractures indicate that increased awareness of the risk of hip fracture is warranted in patients with MS. Attention should particularly be paid for MS patients aged 30–69 and for more disabled patients (i.e., who have a higher expanded disability status scale score). The use of antidepressants further increased fracture risks. The results for patients with MS exposed to glucocorticoids (GCs) were conflicting, although generally the link between GC use and fracture risk has been well established. A clinical risk score for fracture risk estimation may be a starting point for the communication of an individual’s fracture risk in patients with MS, such as the FRAX score or the score presented in one of the chapters of this thesis, which includes MS as a risk factor. A measurement of the bone mineral density may be the next step to determine if preventative treatment, such as bisphosphonates, strontium ranelate, raloxifene or denosumab, is indicated. Other possible interventions are the intake of calcium and vitamin D tablets, and the prevention of falls. Treatment with TZDs in diabetic patients has been associated with a relatively small increased fracture risk for women. If a patient has several other risk factors for fracture, such as a previous fracture, exposure to GCs, or a higher age, a fracture risk assessment may be considered. If this assessment shows an absolute fracture risk that is substantial, then discontinuation of TZD use may be an option. However, this involves a benefit-risk assessment between the best treatment option for diabetes and the risk of fractures. Multi-country studies add valuable insights to the field of observational research. Whether they are worth the effort depends on the specific exposure and outcome being investigated, the quality and completeness of data recording in the separate registries, the ability to gain access to individual patient data if needed and the willingness to invest time and money. When different registries are combined, a crucial step is to investigate the features of these separate registries and the characteristics of patients. Ideally, there should be as much consistency as possible between data from the different sources in terms of study design and definitions of exposure, outcome and risk factors before combining the data. Access to individual patient data is therefore a major strength for a multi-country study
Risk of fractures in patients with multiple sclerosis: a population-based cohort study.
No full textOBJECTIVE: To examine the risk of fracture in patients with multiple sclerosis (MS) compared with population-based controls. METHODS: A population-based cohort study was performed in the Dutch PHARMO Record Linkage System (1998-2008). Patients with MS (n = 2,415) were matched by year of birth, sex, and practice to up to 6 patients without MS (controls). We used Cox proportional hazards models to estimate the hazard ratio (HR) of fracture in MS. Time-dependent adjustments were made for age, history of disease, and drug use. RESULTS: During follow-up, there were 59 fractures among patients with MS (2.4%) and 227 fractures among controls (1.8%). Patients with MS had a 1.7-fold increased risk of osteoporotic fracture (HR 1.73 [95% confidence interval (CI) 1.18-2.53]) and a 4-fold increased risk of hip fracture (HR 4.08 [95% CI 2.21-7.56]). The risk of osteoporotic fracture was significantly greater for patients with MS who had been prescribed antidepressants (HR 3.25 [95% CI 1.77-5.97]) or hypnotics/anxiolytics (HR 3.40 [95% CI 2.06-5.63]) in the previous 6 months, compared with controls. CONCLUSIONS: Increased awareness of the risk of hip fracture is warranted in patients with MS, especially in those who have recently been prescribed antidepressants or hypnotics/anxiolytics
Whistleblowing in Italy : rights and protections for employees
No full textThis paper examines the whistleblowing in the Italian legal system. In the lack ofproper rules on such a phenomenon (quite uncommon in the Italian social reality, also due to cultural reasons) except for the civil servants, the paper goes on analysing, on the one hand, the provision applicable to the civil servants (i.e. art. 54 of the Legislative Decree no. 165/2001), and on the other hand, the instruments provided for by the Italian legal system as general principles, which can be applied by the judge in order to protect the whistleblowers in the private sector (in particular the rules against retaliatory and discriminatory acts and mobbing). The Author stresses that the recalled protection, although effective (also after the so-called 'Monti's reform', id est the Law No. 92/2012), could be not sufficient both because of the allocation of the burden of proof, and because it is applicable to the employees and only partially (as the Author explains in the last paragraph) to the whistleblowing in the context of self-employment. Then the paper analyses the balancing performed by the Italian caselaw between the right to information and the right of criticism, on one side, and the right to secrecy set forth by law in respect of business facts and information, and the personality rights granted to the employer by the Constitution,on the other side. Finally the paper deals with the applicable procedures, introduced by disciplinary codes, also according to the Legislative Decree No. 231/2001, and the problems related to internal reporting systems, in particular the balancing between the needs for the whistleblower's protection and the positive law in the matter of protection of the privacy of the person to whom the complaint relates according to the Legislative Decree No. 196/2003
L'obbligo di ripescaggio nel licenziamento per giustificato motivo oggettivo di tipo economico alla luce del Jobs Act
No full textIl contributo si interroga sul ruolo che, in seguito alle ultime riforme del lavoro, ha assunto il cd. ripescaggio all’interno del licenziamento per giustificato motivo oggettivo di tipo economico. Nella prima parte del saggio, l’esame dei più recenti orientamenti della giurisprudenza, in particolare di quella sull’onere della prova, conduce alla conclusione che il ripescaggio è parte integrante del gmo posto dall’art. 3, l. 604/1966 inteso quale limite interno (o causale) dell’atto di licenziamento, in quanto costituisce il nesso causale negativofra riorganizzazione disposta dal datore e mansioni del lavoratore. Il significato così assunto dal gmo, pur costituendo certo un limite “minimale” dell’atto di licenziamento, risulta comunque conforme ai principi costituzionali, eurounitari e internazionali, secondo l’interpretazione consolidatasi fino ad oggi. La seconda parte del lavoro analizza come la nuova disciplina dello ius variandi (art. 2103 c.c. come modificato dall’art. 3, d.lgs. 81/2015) impatta sulla struttura e sull’ampiezza del ripescaggio. Partendo dal presupposto che il nuovo testo dell’art. 2103 c.c. amplia il debito del lavoratore, includendovi tutte le mansioni appartenenti al medesimo livello di inquadramento rispetto alle mansioni di assunzione (1 co.) e le mansioni del livello immediatamente inferiore (co. 2) – l’A. giunge alla conclusione che il ripescaggio costituisce oggi oggetto di un vero e proprio onere e si estende a tutte le mansioni che integrano il debito di lavoro. Il datore di lavoro infatti ha l’onere, a pena di ingiustificatezza del licenziamento, di cooperare all’adempimento del lavoratore e, dunque, di adibire il lavoratore, nell’esercizio del proprio potere direttivo, ad una delle mansioni dovute, dello stesso livello o del livello immediatamente inferiore rispetto alle mansioni di assunzione. Il mancato rispetto del ripescaggio, così trasformato dall’art. 2103 nuovo testo c.c., è poi corredato da un successivo ed autonomo obbligo di formazione, che grava sul datore di lavoro. Infine, a corollario del ragionamento, l’A. ritiene che il “fatto giuridico” la cui “manifesta insussistenza” dà luogo, ai sensi dell’art. 18, co. 5, St. lav. alla tutela reintegratoria attenuata includa anche il mancato rispetto del ripescaggio, nell’accezione risultante dal combinato disposto dell’art. 3 l. 604/1966 e art. 2103 nuovo testo c.cTHE DUTY OF «REPECHAGE» IN THE DISMISSAL FOR OBJECTIVE ECONOMIC REASONS IN THE LIGHT OF THE JOBS ACT REFORM.
The essay focuses on the role of repêchage in the definition of the dismissal for objective economic reasons after the recent Italian labour law reforms. In the first part of the essay, moving from the analysis of the case-law, especially the one concerning the burden of proof, the author highlights that repêchage is part of the definition of dismissal for objective economic reasons as provided for by Art. 3 Law no. 604/1966, as it represents the causal link between the reorganization of the firm and the workers’ skills. This is in line with both the Italian Constitution and the principles at supranational and international level. In the second part of the essay, the author analyses how the new text of Art. no. 2103 c.c. (as reformed by delegated decree no. 81/2015) affects the duty of repêchage. According to the author, the new art. 2103, broadening the range of tasks the employee can be assigned to in the workplace, has also broadened the notion of repêchage. In her conclusive remarks, she argues that an employer’s failure to fulfil the duty of repêchage, should lead to the reinstatement of the employee under art. 18, co. 5, St. la
Il controllo a distanza dell’attività dei lavoratori dopo il “Jobs Act” (art. 23 D.Lgs. 151/2015) : spunti per un dibattito
No full textL’introduzione mira a offrire una panoramica del nuovo art. 4 St.lav., in materia di potere di controllo del datore di lavoro, recentemente modificato dall’ultima riforma del lavoro (c.d. Jobs Act).
In particolare, dopo una sommaria esposizione delle ragioni sottostanti la nuova norma, volte ad adeguare il potere di controllo del datore di lavoro all’evoluzione dei dispositivi tecnologici presenti sul luogo di lavoro, l’Autrice individua e si sofferma, in una prospettiva critica, sulle eterogenee e complesse questioni interpretative poste dalla novella.The introduction aims at giving an overview of the new article 4 of the
Worker’s Statute (Law no. 300/1970), concerning the employer’s monitoring
powers, as recently reformed by the latest Italian Labour Reform (the so called
Jobs Act).
In particular, after a brief explanation of the rationale underlying the new
rule, in order to make the employer’s control power compatible with the
improvement of technological tools in the workplace, the Author critically lists
and takes into consideration the heterogeneous and complicated interpretative
issues raised by the brand new reform
Multi-Database Methodologies to Enhance Real-World Evidence Generation
No full textIn using multiple databases, the challenges faced in pharmacoepidemiology are more complicated compared to those that use only a single database. The aim of this thesis was to pinpoint those challenges associated, and to showcase and compare modern strategies employed in these studies. It guides researchers about appropriate methodologies and strategies for performing multi-database studies. It can inform stakeholders using real-world evidence (RWE), including regulatory agencies, health technology assessment agencies and clinical personnel, to make decisions about medicines. Chapter 2 focuses on the transparent conduct of, and the potential strategies involved with multi-database RWE research. First, in Chapter 2.1, a systematic review of how missing data is reported and subsequently handled in such multi-database pharmacoepidemiologic studies, is presented. Afterwards, multiple comparisons of strategies for conducting multi-database RWE studies are investigated. Chapter 2.2 compares the syntactic harmonisation of two electronic healthcare databases provided by a common data model (CDM) to a common protocol-only approach when executing a pharmacoepidemiologic RWE cohort study. This case study investigated the risk of bleeding and cardiovascular disease outcomes in direct oral anticoagulants versus vitamin K antagonists in patients with non-valvular atrial fibrillation. Consistency in study population characteristics, outcome counts, and drug effect estimates was assessed. Chapter 2.3 additionally compares this syntactic harmonisation provided by the ConcePTION CDM to the semantic harmonisation provided by the OMOP CDM in one electronic health record database, for the same parameters. Chapter 3 contains two multi-database RWE studies, where heterogeneity was analyzed. In Chapter 3.1, a drug utilisation study of rivaroxaban used for the management of atherosclerotic cardiovascular disease is presented, using a common protocol approach in two European electronic healthcare databases. In Chapter 3.2, a study investigating the risk of bleeding and stroke after the introduction of direct oral anticoagulants, using data from four European countries is presented. We analysed the persistence of study result heterogeneity after methodological harmonisation as to whether it reveals potential disparities in drug use, clinical practice, or the underlying population across the included databases. Finally, a general discussion of the findings, and recommendations for performing multi-database RWE studies, are made in Chapter 4
Ayaanella M.T. Khan & Anis 2017, gen. nov.
No full textAyaanella M.T. Khan & Anis gen. nov. (Figs 1–10) Type species. Ayaanella globugaster M.T. Khan & Anis sp. nov. Description. Female. Head (Fig. 1); antennal torulus placed slightly above lower margin of eye; malar space dark, as long as or shorter than eye width; ocelli arranged in obtuse triangle; mandible (Fig. 2) 4-dentate, third tooth shorter, and a concavity between third and fourth teeth; maxillary palp (Fig. 3) unsegmented, swollen basally, with one seta at apex. Antennal formula 1, 1, (2), 2, 3; antenna (Figs 5–8) with 2 anelli (Figs 7, 8: A1 and A2); funicle 2 segmented, segments asymmetrical, with PLS, F2 broader than long; clava 3-segmented with very long setae and PLS. Mesosoma with pronotum medially divided into two plates; mid lobe of mesoscutum and scutellum each with 2 pairs (2+2) setae; side lobe of mesoscutum with 1 seta along anterolateral corner and axilla; propodeal margin almost straight posteriorly and about as long as metanotum medially; posterior two-thirds of mesoscutum, and scutellum with longitudinally cellulate sculpture, anterior one-third of mesoscutum with polygonal cells. Fore wing hyaline with venation extending to slightly less than half wing length; costal cell very narrow; marginal vein longer than premarginal or stigmal veins; premarginal vein broader than marginal vein; RS1 absent [except two or three setae below stigmal vein]; disc moderately densely setose with setae arranged in rows. Legs with tarsal formula 3-3-3. Metasoma longer than mesosoma; ovipositor short, extending from TV of gaster and hardly exserted. Male. Unknown. Etymology. The genus is named after the son of the second author (SBA), Ayaan + ‘-ella’ Latin suffix added to generic name.Published as part of Khan, Mohd Talib & Anis, Shoeba Binte, 2017, A new genus of Trichogrammatidae (Hymenoptera: Chalcidoidea) from India, pp. 165-168 in Zootaxa 4344 (1) on pages 165-166, DOI: 10.11646/zootaxa.4344.1.9, http://zenodo.org/record/104236
Il licenziamento nullo perchè discriminatorio, intimato in violazione di disposizioni di legge o in forma orale
No full textL’articolo esamina le varie forme di licenziamento nulle ai sensi del Jobs Act (licenziamento discriminatorio; licenziamento per ritorsione; licenziamento per violazione di legge; licenziamento per disabilità fisica e psichica; licenziamento per mancato superamento del periodo di comporto; licenziamento intimato in forma orale) sia al fine di definire i confini delle varie figure – anche rispetto alla nozione di licenziamento ingiustificato – sia per dipanare la questione delle tutele applicabili. Tale secondo problema è rilevante perché il Jobs Act a fronte delle varie ipotesi di licenziamento nullo non sempre esplicita la forma di tutela applicabile. Nel contributo l’A. sostiene l’idea che – benchè sia indubbio che in via generale il Jobs Act ha elevato a regola la tutela indennitaria e ha relegato ad eccezione la tutela reintegratoria – tuttavia con specifico riferimento all’area del licenziamento nullo esso ha riconfermato la centralità della tutela reintegratoria in considerazione dei particolari interessi della persona del lavoratore che entrano in gioco. Ne deriva che le varie ipotesi di licenziamento nullo – anche ove la legge non contempli una previsione specifica; sono soggette alla tutela reintegratoria ex art. 18 St.lav. o alla tutela reintegratoria “di diritto comune”.The article examines the various forms of dismissal void under the Jobs Act (discriminatory dismissal, dismissal for retaliation, dismissal for violation of the law, dismissal for physical and mental disability, dismissal for failure to exceed the period of compensation, dismissal announced orally) in order to define the boundaries of the various figures; also with respect to the notion of unfair dismissal; and to solve the problem of the applicable protections. This second problem is relevant because the Jobs Act in the face of the various hypotheses of invalid dismissal does not always explicitly the form of protection applicable. In the contribution, the Author supports the idea that; although it is undoubted that in general the Jobs Act has elevated to rule the indemnity protection and has relegated to exception the reinstatement protection; however, with specific reference to the area of invalid dismissal it has reconfirmed the centrality of the reinstatement protection in view of the particular interests of the person of the worker who come into play. It follows that the various hypotheses of invalid dismissal; even where the law does not provide for a specific provision; are subject to the reintegration protection pursuant to art. 18 of Statuto dei Lavoratori or to the reintegration protection "under common law
A combinatorial approach to electronic healthcare records in pharmacoepidemiology
No full textThere is a need to know when multi-country observational studies are useful and how they should be performed and interpreted, because there are no well-established methods to deal with the combination of data from several independent electronic healthcare registries. The overall aim of this thesis was to explore the value of using data from multiple countries when estimating the risk of fractures for patients with multiple sclerosis (MS) and the risk of fractures for patients exposed to thiazolidinediones (TZDs). Data were retrieved from three different electronic healthcare registries: the British General Practice Research Database (GPRD), the Dutch PHARMO Record Linkage System (RLS), and the Danish National Health Registers linked to the Danish MS Registry. Our studies of MS and fractures indicate that increased awareness of the risk of hip fracture is warranted in patients with MS. Attention should particularly be paid for MS patients aged 30–69 and for more disabled patients (i.e., who have a higher expanded disability status scale score). The use of antidepressants further increased fracture risks. The results for patients with MS exposed to glucocorticoids (GCs) were conflicting, although generally the link between GC use and fracture risk has been well established. A clinical risk score for fracture risk estimation may be a starting point for the communication of an individual’s fracture risk in patients with MS, such as the FRAX score or the score presented in one of the chapters of this thesis, which includes MS as a risk factor. A measurement of the bone mineral density may be the next step to determine if preventative treatment, such as bisphosphonates, strontium ranelate, raloxifene or denosumab, is indicated. Other possible interventions are the intake of calcium and vitamin D tablets, and the prevention of falls. Treatment with TZDs in diabetic patients has been associated with a relatively small increased fracture risk for women. If a patient has several other risk factors for fracture, such as a previous fracture, exposure to GCs, or a higher age, a fracture risk assessment may be considered. If this assessment shows an absolute fracture risk that is substantial, then discontinuation of TZD use may be an option. However, this involves a benefit-risk assessment between the best treatment option for diabetes and the risk of fractures. Multi-country studies add valuable insights to the field of observational research. Whether they are worth the effort depends on the specific exposure and outcome being investigated, the quality and completeness of data recording in the separate registries, the ability to gain access to individual patient data if needed and the willingness to invest time and money. When different registries are combined, a crucial step is to investigate the features of these separate registries and the characteristics of patients. Ideally, there should be as much consistency as possible between data from the different sources in terms of study design and definitions of exposure, outcome and risk factors before combining the data. Access to individual patient data is therefore a major strength for a multi-country study
The risk of fracture in patients with multiple sclerosis: the UK general practice research database
No full textPatients with multiple sclerosis (MS) may be at an increased risk of fracture owing to a greater risk of falling and decreased bone mineral density when compared with the general population. This study was designed to estimate the relative and absolute risk of fracture in patients with MS. We conducted a population-based cohort study using data from the UK General Practice Research Database linked to the National Hospital Registry (1997–2008). Incident MS patients (n? =?5565) were matched 1:6 by year of birth, sex, and practice with patients without MS (controls). Cox proportional-hazards models were used to derive adjusted hazard ratios (HRs) for fracture associated with MS. Time-dependent adjustments were made for age, comorbidity, and drug use. Absolute 5- and 10-year risks of fracture were estimated for MS patients as a function of age. Compared with controls, MS patients had an almost threefold increased risk of hip fracture [HR?=?2.79, 95% confidence interval (CI) 1.83–4.26] and a risk of osteoporotic fracture that was increased 1.4-fold (HR?=?1.35, 95% CI 1.13–1.62). Risk was greater in patients who had been prescribed oral/intravenous glucocorticoids (GCs; HR?=?1.85, 95% CI 1.14–2.98) or antidepressants (HR?=?1.79, 95% CI 1.37–2.35) in the previous 6 months. Absolute fracture risks were low in younger MS patients but became substantial when patients were older than 60 years of age. It is concluded that MS is associated with an increased risk of fracture. Fracture risk assessment may be indicated in patients with MS, especially those prescribed GCs or antidepressants
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