scholarly journals PHILEOS (haemoPHILia and ostEoporOSis) Study: protocol of a multicentre prospective case–control study

BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e042283
Author(s):  
Brigitte Tardy‐Poncet ◽  
Barbara Play ◽  
Aurélie Montmartin ◽  
Pauline Damien ◽  
Edouard Ollier ◽  
...  

IntroductionTwo meta-analyses showed lower bone mineral density (BMD) in patients with haemophilia (haemophilia type and severity were often not specified) compared with healthy controls. This finding could be related to reduced mobility and sedentary lifestyle, and/or hepatitis C or HIV infection. The aim of this study is to determine osteoporosis prevalence in patients with haemophilia classified in function of the disease type (A or B) and severity, and to evaluate the potential role of regular prophylactic factor replacement (early vs delayed initiation) in preserving or restoring BMD.Methods and analysisThe haemoPHILia and ostEoporOSis Study is a prospective, controlled, multicentre study that will include patients in France (13 haemophilia treatment centres), Belgium (1 centre) and Romania (1 centre). In total, 240 patients with haemophilia and 240 matched healthy controls will be recruited (1:1). The primary objective is to determine osteoporosis prevalence in patients with severe haemophilia A and B (HA and HB) without prophylaxis, compared with healthy controls. Secondary outcomes include: prevalence of osteoporosis and osteopenia in patients with mild, moderate and severe HA or HB with prophylaxis (grouped in function of their age at prophylaxis initiation), compared with healthy subjects; BMD in patients with HA and HB of comparable severity; correlation between BMD and basal factor VIII/IX levels and thrombin potential; and quantification of plasmatic markers of bone remodelling (formation and resorption) in patients with haemophilia.Ethics and disseminationThe protocol was approved by the French Ethics Committee and by the French National Agency for Medicines and Health Products Safety (number: 2019-A03358-49). The results of this study will be actively disseminated through scientific publications and conference presentations.Trial registration numberNCT04384341.

BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e038391
Author(s):  
Jennifer le Guevelou ◽  
Colin Debaigt ◽  
Esma Saada-Bouzid ◽  
Julien Viotti ◽  
Nazim Khalladi ◽  
...  

IntroductionUp to 50% of soft tissue sarcoma (STS) patients develop metastases in the course of their disease. Cytotoxic therapy is a standard treatment in this setting but yields average tumour response rates of 25% at first line and ≤10% at later lines. In oligometastatic stage, stereotactic body radiation therapy (SBRT) allows reaching high control rates at treated sites (≥80%) and is potentially equally effective to surgery in term of overall survival. In order to shift the balance towards antitumour immunity by multisite irradiation, radiation could be combined with inhibitors of the immunosuppressive pathways.Methods and analysisSTEREOSARC is a prospective, multicentric, randomised phase II, designed to evaluate the efficacy of SBRT associated with immunotherapy versus SBRT only. Randomisation is performed with a 2:1 ratio within two arms. The primary objective is to evaluate the efficacy, in term of progression-free survival (PFS) rate at 6 months, of immunomodulated stereotactic multisite irradiation in oligometastatic sarcoma patients. The secondary objectives include PFS by immune response criteria, overall survival, quality-of-life evaluation and developing mathematical models of tumour growth and dissemination predictive of oligometastatic versus polymetastatic evolution. Patients will be randomised in two groups: SBRT with atezolizumab and SBRT alone. The total number of included patients should be 103.Trial registrationThe trial is registered on ClinicalTrials.gov (ID: NCT03548428).Ethics and disseminationThis study has been approved by Comité de Protection des Personnes du sud-ouest et outre-mer 4 on 18 October 2019 (Reference CPP2019-09-076-PP) and from National Agency for Medical and Health products Safety (Reference: MEDAECNAT-2019-08-00004_2017-004239-35) on 18 September 2019.The results will be disseminated to patients upon individual request or through media release from scientific meetings. The results will be communicated through scientific meetings and publications.


2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Zhuoran Hu ◽  
Lei Zhang ◽  
Zhiming Lin ◽  
Changlin Zhao ◽  
Shuiming Xu ◽  
...  

Abstract Background To explore the prevalence of bone loss among patients with rheumatoid arthritis (RA) and healthy controls (HC) and further explored the risk factors for osteopenia and osteoporosis of RA patients. Methods A cross-sectional survey was undertaken in four hospitals in different districts in South China to reveal the prevalence of bone loss in patients. Case records, laboratory tests, and bone mineral density (BMD) results of patients were collected. Traditional multivariable logistic regression analysis and two machine learning methods, including least absolute shrinkage selection operator (LASSO) and random forest (RF) were for exploring the risk factors for osteopenia or osteoporosis in RA patients. Results Four hundred five patients with RA and 198 HC were included. RA patients had lower BMD in almost BMD measurement sites than healthy controls; the decline of lumbar spine BMD was earlier than HC. RA patients were more likely to comorbid with osteopenia and osteoporosis (p for trend < 0.001) in the lumbar spine than HC. Higher serum 25-hydroxyvitamin D3 level and using tumor necrosis factor inhibitor in the last year were protective factors; aging, lower body mass index, and increased serum uric acid might be risk factors for bone loss. Conclusions RA patients were more prone and earlier to have bone loss than HC. More attention should be paid to measuring BMD in RA patients aging with lower BMI or hyperuricemia. Besides, serum vitamin D and all three measurement sites are recommended to check routinely. TNFi usage in the last year might benefit bone mass.


BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e043807
Author(s):  
Jiantong Shen ◽  
Wenming Feng ◽  
Yike Wang ◽  
Qiyuan Zhao ◽  
Billong Laura Flavorta ◽  
...  

IntroductionEfficacy of aliskiren combination therapy with other antihypertensive has been evaluated in the treatment of patients with hypertension in recent systematic reviews. However, most previous reviews only focused on one single health outcome or one setting, none of them made a full summary that assessed the impact of aliskiren combination treatment comprehensively. As such, this umbrella review based on systematic reviews and meta-analyses is aimed to synthesise the evidences on efficacy, safety and tolerability of aliskiren-based therapy for hypertension and related comorbid patients.Methods and analysisA comprehensive search of PubMed, EMBASE, Cochrane Library, CNKI published from inception to August 2020 will be conducted. The selected articles are systematic reviews which evaluated efficacy, safety and tolerability of aliskiren combination therapy. Two reviewers will screen eligible articles, extract data and evaluate quality independently. Any disputes will be resolved by discussion or the arbitration of a third person. The quality of reporting evidence will be assessed using the Assessment of Multiple Systematic Reviews V.2 tool tool. We will take a mixed-methods approach to synthesising the review literatures, reporting summary of findings tables and iteratively mapping the results.Ethics and disseminationEthical approval is not required for the study, as we would only collect data from available published materials. This umbrella review will be also submitted to a peer-reviewed journal for publication after completion.PROSPERO registration numberCRD42020192131.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1759.2-1759
Author(s):  
N. Toroptsova ◽  
O. Dobrovolskaya ◽  
O. Nikitinskaya ◽  
N. Demin ◽  
A. Smirnov ◽  
...  

Background:The onset of the disease in young and middle age is typical for rheumatic diseases (RDS), but most studies on osteoporosis were conducted in patients (pts) older than 50 years, which included postmenopausal women.Objectives:To assess bone mineral density (BMD), fracture frequency and the factors associated with low BMD in premenopausal women with RDs.Methods:160 women (median age, 36 [29; 43] years): 120 pts with RDs (43 rheumatoid arthritis (RA), 53 systemic sclerosis (SSc) and 24 psoriatic arthritis (PsA)) and 40 age-matched healthy controls were enrolled in the study. We performed a dual-energy X-ray absorptiometry (DXA, Hologic Discovery A, USA) to measure BMD in lumbar spine, femoral neck and total hip. BMD decreasing grade was evaluated by the Z-score <-2SD. All pts were interviewed using a unified questionnaire including assessment of daily dietary calcium intake. Serum vitamin D, C-reactive protein and erythrocyte sedimentation rate (ESR) measurements were done.Results:25% pts with RDs and only 8% healthy controls have low BMD (p=0.02). RA, SSc and PsA pts had low BMD in 37%, 21% and 13%, respectively, that was more often than in healthy women (p=0.004, p=0.046 and p= 0.081, respectively). 9,3% RA pts and 7,5% SSc pts had low energy fractures. BMD of RDs pts in all areas of measurement demonstrated a direct correlation with height, weight, body mass index, and serum vitamin D concentration and an inverse correlation with the cumulative dose of glucocorticoids. Also, proximal femur BMD inversely correlated with RDs duration. BMD of femoral neck and total hip inversely correlated with C-reactive protein level in SSc pts. In RA women we found a direct correlation between lumbar spine and femur neck BMD and ESR.Conclusion:25% of premenopausal women with RDs had reduced BMD and needed monitoring and osteoporosis prevention, while 9.3% pts with RA and 7.5% women with SSc needed anti-osteoporotic treatment.Disclosure of Interests:None declared


Bone Research ◽  
2021 ◽  
Vol 9 (1) ◽  
Author(s):  
Xiaowei Zhu ◽  
Weiyang Bai ◽  
Houfeng Zheng

AbstractOsteoporosis is a common skeletal disease, affecting ~200 million people around the world. As a complex disease, osteoporosis is influenced by many factors, including diet (e.g. calcium and protein intake), physical activity, endocrine status, coexisting diseases and genetic factors. In this review, we first summarize the discovery from genome-wide association studies (GWASs) in the bone field in the last 12 years. To date, GWASs and meta-analyses have discovered hundreds of loci that are associated with bone mineral density (BMD), osteoporosis, and osteoporotic fractures. However, the GWAS approach has sometimes been criticized because of the small effect size of the discovered variants and the mystery of missing heritability, these two questions could be partially explained by the newly raised conceptual models, such as omnigenic model and natural selection. Finally, we introduce the clinical use of GWAS findings in the bone field, such as the identification of causal clinical risk factors, the development of drug targets and disease prediction. Despite the fruitful GWAS discoveries in the bone field, most of these GWAS participants were of European descent, and more genetic studies should be carried out in other ethnic populations to benefit disease prediction in the corresponding population.


Author(s):  
Saber Yezli ◽  
Abdulaziz Mushi ◽  
Yasir Almuzaini ◽  
Bander Balkhi ◽  
Yara Yassin ◽  
...  

The Hajj mass gathering is attended by over two million Muslims each year, many of whom are elderly and have underlying health conditions. Data on the number of pilgrims with health conditions would assist public health planning and improve health services delivery at the event. We carried out a systematic review of literature based on structured search in the MEDLINE/PubMed, SCOPUS and CINAHL databases, and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, to estimate the prevalence of diabetes and hypertension among Hajj pilgrims. Twenty-six studies conducted between 1993 and 2018 with a total of 285,467 participants were included in the review. The weighted pooled prevalence rates of hypertension and diabetes among Hajj pilgrims in all included studies were 12.2% (95% CI: 12.0–12.3) and 5.0% (95% CI: 4.9–5.1), respectively. The reported prevalence of other underlying health conditions such as chronic respiratory, kidney or liver disease, cardiovascular disease, cancer and immune deficiency were generally low. Potentially a large number of pilgrims each Hajj have diabetes and/or hypertension and other underlying health conditions. Hajj could be a great opportunity to reduce the burden of these diseases within the over 180 countries participating in the event by identifying undiagnosed cases and optimizing patients’ knowledge and management of their conditions. Prospero registration number: CRD42020171082.


BMJ Open ◽  
2017 ◽  
Vol 7 (9) ◽  
pp. e017868
Author(s):  
Joey S.W. Kwong ◽  
Sheyu Li ◽  
Wan-Jie Gu ◽  
Hao Chen ◽  
Chao Zhang ◽  
...  

IntroductionEffective selection of coronary lesions for revascularisation is pivotal in the management of symptoms and adverse outcomes in patients with coronary artery disease. Recently, instantaneous ‘wave-free’ ratio (iFR) has been proposed as a new diagnostic index for assessing the severity of coronary stenoses without the need of pharmacological vasodilation. Evidence of the effectiveness of iFR-guided revascularisation is emerging and a systematic review is warranted.Methods and analysisThis is a protocol for a systematic review of randomised controlled trials and controlled observational studies. Electronic sources including MEDLINE via Ovid, Embase, Cochrane databases and ClinicalTrials.gov will be searched for potentially eligible studies investigating the effects of iFR-guided strategy in patients undergoing coronary revascularisation. Studies will be selected against transparent eligibility criteria and data will be extracted using a prestandardised data collection form by two independent authors. Risk of bias in included studies and overall quality of evidence will be assessed using validated methodological tools. Meta-analysis will be performed using the Review Manager software. Our systematic review will be performed according to the guidance from the Cochrane Handbook for Systematic Reviews of Interventions and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement.Ethics and disseminationEthics approval is not required. Results of the systematic review will be disseminated as conference proceedings and peer-reviewed journal publication.Trial registration numberThis protocol is registered in the International Prospective Register of Systematic Reviews (PROSPERO), registration number CRD42017065460.


2021 ◽  
pp. jech-2021-216874
Author(s):  
Alessandro Sindoni ◽  
Federica Valeriani ◽  
Francesca Gallè ◽  
Giorgio Liguori ◽  
Vincenzo Romano Spica ◽  
...  

BackgroundTattoos were historically associated with deviant behaviours or religious and other social purposes, but in the last decades, they have gained increasing popularity and have become a mainstream. The aim of this systematic review is to assess the literature evidence about decorative tattoos complications, considering both infective and non-infective risks.MethodsThis systematic review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Statement. We searched the following electronic bibliographic databases: PubMed, Scopus and Web of Science (science and social science citation index).ResultsThe literature search resulted in 6473 studies. A total of 207 full articles were considered potentially relevant and were reviewed independently by researchers. After full-text evaluation, 152 of 207 articles were excluded, as they did not meet selection criteria. The remaining 55 studies were included in the systematic review and their quality assessment was performed. Ten studies reported microbiological complications, 37 reported non-microbiological effects and eight reported either microbiological and non-microbiological complications.ConclusionsSeveral well-known and uncommon risks are associated with tattooing and tattoo after-care. Public health authorities could take into account health education programmes for tattooists and customers in order to prevent health complications in people with tattoos.PROSPERO registration numberCRD42020177972.


2021 ◽  
Vol 17 ◽  
Author(s):  
Gehan Elolemy ◽  
Waleed Hassan ◽  
Mohamed Nasr ◽  
Eman Baraka

Objectives: was to assess the frequency of hypovitaminosis D in patients with ankylosing spondylitis (AS) compared to healthy controls and to evaluate its association with disease activity, structural damage and bone mineral density (BMD). Methods: Serum 25(OH) D in 30 AS male patients was compared to 30 matched healthy controls. AS disease activity was assessed using AS Disease Activity Score and C - reactive protein (ASDAS-CRP). Bath AS Functional Index (BASFI) and Bath AS Metrology Index (BASMI) were used to assess the functional impairment and the spinal mobility respectively. Radiological damage was scored according to modified Stoke AS Spine Score (mSASSS) and BMD was measured in the lumbar spine and femoral neck. Results: The mean serum 25(OH)D levels in AS patients were significantly lower compared to healthy controls (27.73 ± 14.27 vs. 38.46 ± 8.11ng/ml, P <0.001). Among the patients, 60% exhibited hypovitaminosis D. AS patients with hypovitaminosis D had significantly higher ASDAS-CRP (p<0.001), BASFAI (p=0.0003) and mSASSS (p=0.04) scores. Additionally, BMD and Z scores at lumbar and femoral sites were significantly reduced in the patients with hypovitaminosis D (P < 0.05). Serum 25(OH)D was positively correlated with BMD (lumbar and femoral; p=0.002 and p=0.01 respectively) and Z scores (lumbar and femoral; p<0.001and p=0.01 respectively), whereas, negatively correlated with ASDAS-CRP (p<0.001), BASFI (p<0.001), mSASSS (p=0.003). ASDAS -CRP was the only significant predictor of hypovitaminosis D in AS patients. Conclusions: hypovitaminosis D is prevalent among AS patients and is associated with increased risk of active disease, impaired function, radiographic severity and bone mineral loss. Future studies with larger sample size are recommended to assess the impact of vitamin D deficiency on radiological progression in AS and to address whether or not vitamin D supplementation will help control active disease.


2021 ◽  
pp. 1-11
Author(s):  
Emre Bora

Abstract Background It is widely accepted that borderline personality disorder (BPD) is associated with significant impairments in mentalization and theory of mind (ToM) which are considered as closely related concepts by many authors particularly in psychoanalytical circles. However, for understanding interpersonal difficulties in personality disorders, it is important to distinguish neuro-social cognitive impairment from the abnormal meta-social-cognitive style of patients. Methods The current systematic review aimed to conduct separate meta-analyses of ‘mentalization’ [reflective functioning (RF] and different aspects of ToM in BPD. A literature search was conducted to locate relevant articles published between January 1990 to July 2021. Random-effect meta-analyses were conducted in 34 studies involving 1448 individuals with BPD and 2006 healthy controls. Results A very large impairment in RF was evident in BPD [d = 1.68, confidence interval (CI) = 1.17–2.19]. In contrast, ToM impairment was modest (d = 0.36, CI = 0.24–0.48). BPD patients underperformed healthy controls in ToM-reasoning (d = 0.44, CI = 0.32–0.56) but not ToM-decoding. Increased HyperToM (d = 0.60, CI = 0.41–0.79) and faux pas recognition (d = 0.62, CI = 0.35–0.90) errors in BPD compared to healthy controls were most robust ToM findings in this meta-analysis. Conclusions BPD is characterized by very severe deficits in RF and modest and selective abnormalities in ToM. Interpersonal problems and difficulties in processing social information in BPD can be best explained by patients' maldaptive meta-social cognitive style and top-down effects of these abnormalities rather than having a primary neuro-social cognitive deficit.


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