Summary Background Intravenous thrombolysis with alteplase alone cannot reperfuse most large-artery strokes. We aimed to determine whether mechanical thrombectomy in addition to intravenous ...thrombolysis improves clinical outcome in patients with acute ischaemic stroke. Methods THRACE is a randomised controlled trial done in 26 centres in France. Patients aged 18–80 years with acute ischaemic stroke and proximal cerebral artery occlusion were randomly assigned to receive either intravenous thrombolysis alone (IVT group) or intravenous thrombolysis plus mechanical thrombectomy (IVTMT group). Intravenous thrombolysis (alteplase 0·9 mg/kg maximum 90 mg, with an initial bolus of 10% of the total dose followed by infusion of the remaining dose over 60 min) had to be started within 4 h and thrombectomy within 5 h of symptom onset. Occlusions had to be confirmed by CT or magnetic resonance angiography. Randomisation was done centrally with a computer-generated sequential minimisation method and was stratified by centre. The primary outcome was the proportion of patients achieving functional independence at 3 months, defined by a score of 0–2 on the modified Rankin scale, assessed in the modified intention-to-treat population (ie, patients lost to follow-up and those with missing data were excluded). Safety outcomes were analysed in the per-protocol population (ie, all patients who did not follow the protocol of their randomisation group precisely were excluded from the analysis). THRACE is registered with ClinicalTrials.gov , NCT01062698. Findings Between June 1, 2010, and Feb 22, 2015, 414 patients were randomly assigned to the IVT group (n=208) or the IVTMT group (n=204). Four patients (two in each group) lost to follow-up and six (four in the IVT group and two in the IVTMT group) with missing data were excluded. 85 (42%) of 202 patients in the IVT group and 106 (53%) of 200 patients in the IVTMT group achieved functional independence at 3 months (odds ratio 1·55, 95% CI 1·05–2·30; p=0·028). The two groups had no significant differences in mortality at 3 months (24 12% deaths of 202 patients vs 27 13% of 206; p=0·70) or symptomatic intracranial haemorrhage at 24 h (four 2% of 185 vs three 2% of 192; p=0·71). Common adverse events related to thrombectomy were vasospasm (33 23% patients) and embolisation in a new territory (nine 6%). Interpretation Mechanical thrombectomy combined with standard intravenous thrombolysis improves functional independence in patients with acute cerebral ischaemia, with no evidence of increased mortality. Bridging therapy should be considered for patients with large-vessel occlusions of the anterior circulation. Funding French Ministry for Health.
Abstract Objectives Existing practice guidelines for osteoarthritis (OA) analyze the evidence behind each proposed treatment but do not prioritize the interventions in a given sequence. The objective ...was to develop a treatment algorithm recommendation that is easier to interpret for the prescribing physician based on the available evidence and that is applicable in Europe and internationally. The knee was used as the model OA joint. Methods ESCEO assembled a task force of 13 international experts (rheumatologists, clinical epidemiologists, and clinical scientists). Existing guidelines were reviewed; all interventions listed and recent evidence were retrieved using established databases. A first schematic flow chart with treatment prioritization was discussed in a 1-day meeting and shaped to the treatment algorithm. Fine-tuning occurred by electronic communication and three consultation rounds until consensus. Results Basic principles consist of the need for a combined pharmacological and non-pharmacological treatment with a core set of initial measures, including information access/education, weight loss if overweight, and an appropriate exercise program. Four multimodal steps are then established. Step 1 consists of background therapy, either non-pharmacological (referral to a physical therapist for re-alignment treatment if needed and sequential introduction of further physical interventions initially and at any time thereafter) or pharmacological. The latter consists of chronic Symptomatic Slow-Acting Drugs for OA (e.g., prescription glucosamine sulfate and/or chondroitin sulfate) with paracetamol at-need; topical NSAIDs are added in the still symptomatic patient. Step 2 consists of the advanced pharmacological management in the persistent symptomatic patient and is centered on the use of oral COX-2 selective or non-selective NSAIDs, chosen based on concomitant risk factors, with intra-articular corticosteroids or hyaluronate for further symptom relief if insufficient. In Step 3, the last pharmacological attempts before surgery are represented by weak opioids and other central analgesics. Finally, Step 4 consists of end-stage disease management and surgery, with classical opioids as a difficult-to-manage alternative when surgery is contraindicated. Conclusions The proposed treatment algorithm may represent a new framework for the development of future guidelines for the management of OA, more easily accessible to physicians.
To estimate the global burden of hip and knee osteoarthritis (OA) as part of the Global Burden of Disease 2010 study and to explore how the burden of hip and knee OA compares with other conditions.
...Systematic reviews were conducted to source age-specific and sex-specific epidemiological data for hip and knee OA prevalence, incidence and mortality risk. The prevalence and incidence of symptomatic, radiographic and self-reported hip or knee OA were included. Three levels of severity were defined to derive disability weights (DWs) and severity distribution (proportion with mild, moderate and severe OA). The prevalence by country and region was multiplied by the severity distribution and the appropriate disability weight to calculate years of life lived with disability (YLDs). As there are no deaths directly attributed to OA, YLDs equate disability-adjusted life years (DALYs).
Globally, of the 291 conditions, hip and knee OA was ranked as the 11th highest contributor to global disability and 38th highest in DALYs. The global age-standardised prevalence of knee OA was 3.8% (95% uncertainty interval (UI) 3.6% to 4.1%) and hip OA was 0.85% (95% UI 0.74% to 1.02%), with no discernible change from 1990 to 2010. Prevalence was higher in females than males. YLDs for hip and knee OA increased from 10.5 million in 1990 (0.42% of total DALYs) to 17.1 million in 2010 (0.69% of total DALYs).
Hip and knee OA is one of the leading causes of global disability. Methodological issues within this study make it highly likely that the real burden of OA has been underestimated. With the aging and increasing obesity of the world's population, health professions need to prepare for a large increase in the demand for health services to treat hip and knee OA.
The Inventory of Parental Representations (IPR), a self-administered questionnaire, was developed primarily to identify styles of attachment in adolescence. However, it did not present stable ...psychometric properties in the various American studies carried out. The aim of this study was to adapt the IPR in French and to provide a shorter version with improved psychometric properties and sound content.
The cross-cultural adaptation and content validity were carried out based on qualitative analysis by an Expert Committee and 10 non-clinical adolescents. For the quantitative analyses a cohort of 535 adolescent volunteers was enrolled, corresponding to 1070 responses, and divided into two groups: development and validation. The study of the metric properties of the adapted version of the IPR was realized in the development group, a sample of 275 responses. In case of mediocre results in the Confirmatory Factor Analysis, the development of a new and reduced IPR structure was planned using a mixed method including Classical Test Theory and Rasch Modelling in the development group. Subsequently, the study of the psychometric properties of the short, adapted version was confirmed in an independent sample of 795 responses (validation group).
Out of 62 items translated, 13 needed adaptations. The analysis of their metric properties produced mediocre results. Content and psychometric property analyses generated two Short version of the IPR in the development group: a paternal scale for Fathers (Short IPRF) with 15 items and a maternal scale for Mothers (Short IPRM) with 16 items. The sound content and good psychometric properties were confirmed in the validation group (Short IPRF: Comparative Fit Index = 0.987, Tucker-Lewis Index = 0.982, Root Mean Square Error of Approximation = 0.027; Short IPRM: Comparative Fit Index = 0.953, Trucker-Lewis Index = 0.927, Root Mean Square Error of Approximation = 0.068). Using Rasch modelling, the attachment was correctly measured overall especially for insecure attachment.
A step-by-step process involving led to the generation of two questionnaires: a paternal scale, the Short IPRF, and a maternal scale with the Short IPRM providing opportunities to use this self-questionnaire to assess attachment among adolescents. Further work will provide a solid rating for this new tool.
Abstract
Administrative databases are an alternative to disease registries as a research tool to study multiple sclerosis. However, they are not initially designed to fulfill research purposes. ...Therefore, an evaluation of their performance is necessary. Our objective was to assess the performance of the French administrative database comprising hospital discharge records and national health insurance databases in identifying individuals with multiple sclerosis, in comparison with a registry that exhaustively compiles resident multiple sclerosis cases in Lorraine, northeastern France, as reference. We recorded all individuals residing in the Lorraine region who were identified by the administrative database or the registry as having multiple sclerosis from 2011 to 2016. We calculated the Matthews correlation coefficient and other concordance indicators. For identifying individuals with multiple sclerosis, the Matthews correlation coefficient by the administrative database was 0.79 (95% CI 0.78–0.80), reflecting moderate performance. The mean time to identification was 5.5 years earlier with the registry than the administrative database. Administrative databases, although useful to study multiple sclerosis, should be used with caution because results of studies based on them may be biased. Our study highlights the value of regional registries that allow for a more exhaustive and rapid identification of cases.
Multiple sclerosis (MS) is a neurodegenerative disease of the central nervous system. An increase in MS incidence over time is reported in several regions of the world. We aimed to describe the ...evolution of the annual MS incidence in the Lorraine region, France, from 1996 to 2015 and to analyze potential components of a possible change by a temporal effect of age at MS onset, MS onset period, and birth cohort, overall and for each sex. Cases were identified from ReLSEP, a population-based registry of MS cases living in Lorraine, northeastern France, with MS onset between 1996 and 2015. Age-period-cohort modeling was used to describe trends in MS incidence. Annual age- and sex-standardized incidences were relatively stable: 6.76/100 000 population (95%CI 5.76-7.91) in 1996 and 6.78/100 000 (95%CI 5.72-7.97) in 2015. The incidence ratio between women and men was 2.4. For all time periods, the peak incidence occurred between ages 25 and 35 years. Age-period-adjusted cohort and age-cohort-adjusted period analyses did not reveal a period or cohort effect. The incidence of MS remained stable over the study period in Lorraine, and we could not identify any particular effect of disease onset period or birth period on this evolution.
Abstract There is growing recognition that involving patients in the development of new patient-reported outcome measures helps ensure that the outcomes that matter most to people living with health ...conditions are captured. Here, we describe and discuss different experiences of integrating patients as full patient research partners (PRPs) in outcomes research from multiple perspectives (e.g., researcher, patient, and funder), drawing from three real-world examples. These diverse experiences highlight the strengths, challenges, and impact of partnering with patients to conceptualize, design, and conduct research and disseminate findings. On the basis of our experiences, we suggest basic guidelines for outcomes researchers on establishing research partnerships with patients, including: 1) establishing supportive organizational/institutional policies; 2) cultivating supportive attitudes of researchers and PRPs with recognition that partnerships evolve over time, are grounded in strong communication, and have shared goals; 3) adhering to principles of respect, trust, reciprocity, and co-learning; 4) addressing training needs of all team members to ensure communications and that PRPs are conversant in and familiar with the language and process of research; 5) identifying the resources and advanced planning required for successful patient engagement; and 6) recognizing the value of partnerships across all stages of research. The three experiences presented explore different approaches to partnering; demonstrate how this can fundamentally change the way research work is conceptualized, conducted, and disseminated; and can serve as exemplars for other forms of patient-centered outcomes research. Further work is needed to identify the skills, qualities, and approaches that best support effective patient-researcher partnerships.
To update the 1997 OMERACT-OARSI (Outcome Measures in Rheumatology-Osteoarthritis Research Society International) core domain set for clinical trials in hip and/or knee osteoarthritis (OA).
An ...initial review of the COMET database of core outcome sets (COS) was undertaken to identify all domains reported in previous COS including individuals with hip and/or knee OA. These were presented during 5 patient and health professionals/researcher meetings in 3 continents (Europe, Australasia, North America). A 3-round international Delphi survey was then undertaken among patients, healthcare professionals, researchers, and industry representatives to gain consensus on key domains to be included in a core domain set for hip and/or knee OA. Findings were presented and discussed in small groups at OMERACT 2018, where consensus was obtained in the final plenary.
Four previous COS were identified. Using these, and the patient and health professionals/researcher meetings, 50 potential domains formed the Delphi survey. There were 426 individuals from 25 different countries who contributed to the Delphi exercise. OMERACT 2018 delegates (n = 129) voted on candidate domains. Six domains gained agreement as mandatory to be measured and reported in all hip and/or knee OA clinical trials: pain, physical function, quality of life, and patient's global assessment of the target joint, in addition to the mandated core domain of adverse events including mortality. Joint structure was agreed as mandatory in specific circumstances, i.e., depending on the intervention.
The updated core domain set for hip and/or knee OA has been agreed upon. Work will commence to determine which outcome measurement instrument should be recommended to cover each core domain.
Aims
To investigate the prevalence of pathological internet use (PIU) and maladaptive internet use (MIU) among adolescents in 11 European countries in relation to demographic, social factors and ...internet accessibility.
Design
Cross‐sectional survey.
Setting
The 7th Framework European Union (EU) funded project, Saving and Empowering Young Lives in Europe (SEYLE), is a randomized controlled trial (RCT) evaluating interventions for risk behaviours among adolescents in Austria, Estonia, France, Germany, Hungary, Ireland, Israel, Italy, Romania, Slovenia and Spain, with Sweden serving as the coordinating centre.
Participants
A total of 11 956 adolescents (female/male: 6731/5225; mean age: 14.9 ± 0.89) recruited from randomly selected schools within the 11 study sites.
Measurements
Internet users were classified by gender into three categories: adaptive, maladaptive and pathological, based on their score in the Young Diagnostic Questionnaire for Internet Addiction (YDQ).
Findings
The overall prevalence of PIU was 4.4%; it was higher among males than females (5.2% versus 3.8%) and differed between countries (χ2 = 309.98; d.f. = 20; P < 0.001). PIU correlated significantly with mean hours online and male gender. The highest‐ranked online activities were watching videos, frequenting chatrooms and social networking; significantly higher rates of playing single‐user games were found in males and social networking in females. Living in metropolitan areas was associated with PIU. Students not living with a biological parent, low parental involvement and parental unemployment showed the highest relative risks of both MIU and PIU.
Conclusions
Across a range of countries in Europe, using the Young Diagnostic Questionnaire for Internet Addiction yields a prevalence of ‘pathological internet use’ of 4.4% among adolescents, but varies by country and gender; adolescents lacking emotional and psychological support are at highest risk.
If any benefit is to be derived from the use of the health-related quality of life (HRQoL) questionnaires in chronic kidney disease (CKD) patients, they should be validated and culturally adapted to ...the target population. We aimed to critically appraise the psychometric properties of HRQoL questionnaires used in African populations with CKD.
Web of Science, Embase, PubMed and PsycINFO databases were searched. Psychometric validation studies of HRQoL questionnaires reporting at least one psychometric property of the COSMIN checklist in CKD African population, published up to October 16, 2023 were included and independently assessed for methodological quality and level of measurement properties by using the COSMIN methodology.
From 1163 articles, 5 full-text were included. Only the Kidney Disease Quality-of-Life questionnaire was translated and cross-culturally adapted for studies of patients with CKD. Internal consistency was of doubtful quality in 4 studies and very good in 1. Its measurement was sufficient in 1 study and insufficient in 4. Test-retest reliability was of doubtful quality in 4 studies. Its measurement was sufficient in 3 studies and insufficient in 1. Structural validity was of inadequate quality in 1 study and very good quality in 1. Its measurement was sufficient in both. Construct validity was of inadequate quality in all studies. Their measurement was insufficient in 4 studies and sufficient in 1.
This review highlighted that only one HRQoL questionnaire used in studies of African populations with CKD underwent a small number of cultural adaptations and psychometric validations, generally of poor methodological quality. HRQoL validation studies in African CKD populations are needed to better take advantage of the benefits in patient care, population health management, and research.
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