scholarly journals Methotrexate dosage as a source of bias in biological trials in rheumatoid arthritis: a systematic review

2016 ◽  
Vol 75 (9) ◽  
pp. 1595-1598 ◽  
Author(s):  
Josefina Durán ◽  
Margarita Bockorny ◽  
Deepan Dalal ◽  
Michael LaValley ◽  
David T Felson

ObjectivesTo evaluate if optimal dose of either oral or injectable regimens of methotrexate (MTX) of 25 mg/week was used in the comparator arms of studies comparing biologic drugs with MTX in rheumatoid arthritis (RA).MethodsA systematic literature search was carried out in MEDLINE, EMBASE and the Cochrane Library databases for randomised controlled trials comparing biologics with MTX in RA. A systematic review was performed among studies that met predefined criteria focusing on assessment of dose of MTX used in the comparator arm. Study authors were contacted when necessary. Study quality was assessed.ResultsA total of 3276 references were identified and 13 trials were included. We obtained maximal dose and regimen for all. The maximal dose of MTX used in the comparator arm of the trials was no more than 20 mg/week in any trial and for all but one trial, MTX was given orally and not by injection. The trial that used an injectable form reached a maximum of 15 mg/week.ConclusionsA suboptimal dose of MTX was used in biological clinical trials performed in RA, particularly regarding route of administration. This may have biased findings in favour of biological agents.

2014 ◽  
Vol 128 (11) ◽  
pp. 948-951 ◽  
Author(s):  
A E L McMurran ◽  
I Khan ◽  
S Mohamad ◽  
M Shakeel ◽  
H Kubba

AbstractBackground:It is common practice to use head bandages for 7–10 days following pinnaplasty. However, head bandages are often troublesome for patients and can lead to serious complications.Method:A systematic review was performed to evaluate the use of head bandages after pinnaplasty. A search of Medline, Embase (Ovid) and CINAHL (EBSCO collections), the Cochrane Library, Pubmed (US National Library of Medicine) and Google Scholar identified 34 related articles. Of these, 14 were deemed relevant and 2 randomised controlled trials, 1 cohort study, 3 case series and 1 literature review met the inclusion criteria.Results:The two randomised controlled trials show no statistically significant difference in complications when a head bandage was used for the standard 7–10 days, for 24 hours or not at all. The three case series show that using a head bandage for 24 hours or not at all are safe alternatives. The review article recommended that when head bandages are applied after pinnaplasty it should be for the shortest duration possible.Conclusion:Based on the available evidence, not using a head bandage at all or using one for a maximum of 24 hours following pinnaplasty is recommended.


Nutrients ◽  
2021 ◽  
Vol 13 (10) ◽  
pp. 3506
Author(s):  
Tala Raad ◽  
Anne Griffin ◽  
Elena S. George ◽  
Louise Larkin ◽  
Alexander Fraser ◽  
...  

Rheumatoid Arthritis (RA) is a chronic autoimmune condition characterized by symptoms of inflammation and pain in the joints. RA is estimated to have a worldwide prevalence of 0.5–1%, with a predominance in females. Diet may play an important role in the symptoms of RA; however, little is known about the effects of various diets. The aim of this systematic review is to explore the effect of dietary interventions, with or without omega-3 supplementation for the management of RA. The electronic databases MEDLINE, EMBASE, CINAHL, and the Cochrane Library were systematically searched for clinical trials investigating dietary interventions, with or without omega-3 supplementation to retrieve papers from inception to April 2021. Randomized and non-randomized controlled trials of dietary interventions in adults with RA were eligible for inclusion. Twenty studies with a total of 1063 participants were included. The most frequently reported outcomes were pain, duration of morning stiffness, joint tenderness, grip strength and inflammatory markers. Dietary interventions with an anti-inflammatory basis may be an effective way for adults with RA seeking complementary treatments, potentially leading to improvements in certain parameters. However, there is a need for longer duration studies that are well-designed and sufficiently powered to investigate the influence of diet on RA.


2020 ◽  
Author(s):  
Daniela Coclite ◽  
Antonello Napoletano ◽  
Silvia Gianola ◽  
Andrea Del Monaco ◽  
Daniela D'Angelo ◽  
...  

Background: Evidence is needed on the effectiveness of wearing face masks in the community to prevent SARS-CoV-2 transmission. Methods: Systematic review and meta-analysis to investigate the efficacy and effectiveness of face mask use in a community setting and to predict the effectiveness of wearing a mask. We searched MEDLINE, EMBASE, SCISEARCH, The Cochrane Library and pre-prints from inception to 22 April 2020 without restriction by language. We rated the certainty of evidence according to Cochrane and GRADE approach. Findings: Our search identified 35 studies, including 3 randomised controlled trials (RCTs) (4017 patients), 10 comparative studies (18984 patients), 13 predictive models, 9 laboratory experimental studies. For reducing infection rates, the estimates of cluster-RCTs were in favour of wearing face masks versus no mask, but not at statistically significant levels (adjusted OR 0.90, 95%CI 0.78-1.05). Similar findings were reported in observational studies. Mathematical models indicated an important decrease in mortality when the population mask coverage is near-universal, regardless of mask efficacy. In the best-case scenario, when the mask efficacy is at 95%, the R0 can fall to 0.99 from an initial value of 16.90. Levels of mask filtration efficiency were heterogeneous, depending on the materials used (surgical mask: 45-97%). One laboratory study suggested a viral load reduction of 0.25 (95%CI 0.09-0.67) in favour of mask versus no mask. Interpretation: The findings of this systematic review and meta-analysis support the use of face masks in a community setting. Robust randomised trials on face mask effectiveness are needed to inform evidence-based policies.


2015 ◽  
Vol 42 (5) ◽  
pp. 760-770 ◽  
Author(s):  
Mads Abildtrup ◽  
Gabrielle H. Kingsley ◽  
David L. Scott

Objective.Calprotectin (myeloid-related protein 8/14), a heterodimeric complex of calcium-binding proteins, is expressed in granulocytes and monocytes. Calprotectin levels are high in synovial tissue, particularly in activated cells adjacent to the cartilage-pannus junction. This systematic review evaluates the use of calprotectin as an indicator of disease activity, therapeutic response, and prognosis in rheumatoid arthritis (RA).Methods.Medline, Scopus, and the Cochrane Library (1970–2013) were searched for studies containing original data from patients with RA in whom calprotectin levels were measured in plasma/serum and/or synovial fluid (SF). We included studies examining associations between calprotectin levels and clinical and laboratory assessments, disease progression, and therapeutic response. There were no restrictions for sample size, disease duration, or length of followup.Results.We evaluated 17 studies (1988–2013) with 1065 patients enrolled; 11 were cross-sectional and 8 had longitudinal designs with 2 studies reporting cross-sectional and longitudinal data. Systemic and SF levels of calprotectin were raised in RA. There was a wide range of levels and marked interstudy and intrastudy variability. Calprotectin levels were high in active disease and were particularly high in rheumatoid factor (RF)-positive patients. Levels fell with effective treatment. Longitudinal data showed that calprotectin was a significant and independent predictor of erosive progression and therapeutic responses, particularly in patients who received effective biological treatments.Conclusion.SF calprotectin levels are high, suggesting there is substantial local production by inflamed synovium. Blood calprotectin levels, though highly variable, are elevated in active RA and fall with effective therapy. High baseline calprotectin levels predict future erosive damage.


Author(s):  
Sukirno Sukirno

Evidence Based Medicine (EBM) merupakan pemanfaatan bukti ilmiah berdasarkan penelitian klinis mutakhir yang sahih dalam tatalaksana proses penyembuhan penyakit. Salah satu syarat utama untuk memfasilitasi pengambilan keputusan klinik yang evidence-based, adalah dengan menyediakan bukti-bukti ilmiah yang relevan. Tipe kajian  diutamakan yang berupa hasil review sistematik, meta-analisis, dan randomised controlled trial (RCT). Salah satu dari lima langkah dalam evidence based medicine yaitu yaitu menelusur  bukti  dari sumber database hasil penelitian yang memuat bukti-bukti ilmiah. PubMed Clinical Queries dan The Cochrane Library merupakan database berisi hasil riset sekunder (systematic-review/meta-analysis) yang mensintesis hasil riset primer. Kolaborasi pustakawan dalam pengambilan keputusan klinis yaitu dengan  memberikan pelatihan  atau menelusur artikel hasil penelitian yang akan digunakan dalam pengambilan klinis dari database yang memuat bukti ilmiah.


2020 ◽  
pp. bmjsrh-2019-200536 ◽  
Author(s):  
Mia Schmidt-Hansen ◽  
Jonathan Lord ◽  
James Hawkins ◽  
Sharon Cameron ◽  
Anuja Pandey ◽  
...  

BackgroundIn order to develop the 2019 National Institute for Health and Care Excellence (NICE) national guideline on abortion care for the National Health Service1 we undertook a systematic review comparing anti-D prophylaxis to no prophylaxis in rhesus D (RhD)-negative women undergoing medical or surgical abortion of pregnancy at ≤13+6 weeks’ gestationMethodsWe searched Embase, Medline and the Cochrane Library on 19 October 2018. We also consulted experts and checked reference lists for any missed trials. Eligible studies were randomised controlled trials and non-randomised comparative studies, published in English from 1985 onwards, comparing anti-D prophylaxis to no anti-D prophylaxis in RhD-negative women undergoing medical or surgical abortion at ≤13+6 weeks’ gestation, and reporting subsequent anti-D isoimmunisation/sensitisation or subsequent affected pregnancy. These outcomes were to be analysed as risk ratios in Review Manager 5.3 using the Mantel-Haenszel statistical method and a fixed or random effect model. The overall quality of the evidence was planned to be assessed using GRADE.ResultsThe search identified 426 potentially relevant studies of which none met the inclusion criteria. Recommendations for practice were therefore based on the clinical expertise of the guideline committee.Conclusions(1) Offer anti-D prophylaxis to women who are Rhesus D negative who are having an abortion after 10+0 weeks’ gestation. (2) Do not offer anti-D prophylaxis to women who are having a medical abortion up to and including 10+0 weeks’ gestation. (3) Consider anti-D prophylaxis for women who are rhesus D negative and are having a surgical abortion up to and including 10+0 weeks’ gestation.


2020 ◽  
pp. 112070002097819
Author(s):  
Henryk Haffer ◽  
Michael Müller ◽  
Rudolf Ascherl ◽  
Carsten Perka ◽  
Tobias Winkler

Background: Heterotopic ossification (HO) is defined as the formation of lamellar bone in extraskeletal soft tissues. HO can be a severe complication after hip arthroplasty but can possibly be prevented by postoperative treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or radiotherapy. Diclofenac is 1 of the most used drugs in HO prophylaxis because it is effective and long established. However, there is still no uniform therapy regimen in terms of duration, dose and side effect profile regarding the application of diclofenac in HO prevention. We have, therefore, conducted the first systematic review investigating diclofenac for HO prophylaxis after hip arthroplasty. The aim of this study is to assess the efficacy, dose and duration of diclofenac therapy in preventing HO after total hip arthroplasty (THA). Methods: According to the PRISMA Guidelines we performed a systematic literature search in EMBASE via Ovid, in MEDLINE via PubMed and in the Cochrane Library addressing all studies in English and German regarding the prophylaxis of HO with diclofenac after THA. We identified 731 potential studies and included 6 randomised controlled trials with 957 patients. Results: The studies were heterogeneous with regard to duration of therapy, dose, comparative group and follow-up period. The therapy duration ranged from 9 to 42 days, the applied diclofenac doses ranged from 75 mg to 150 mg daily. Patients treated with diclofenac showed a significant reduction in the total incidence of HO regarding to the Brooker Classification compared to placebo and no clinically relevant ossifications occured (Brooker III and IV). Conclusions: Diclofenac is efficacious in the prevention of HO and can be used routinely after THA. The existing data indicates that a minimum dose of 75 mg diclofenac per day started on the first postoperative day for a minimum of 9 days is needed to prevent HO with an acceptable incidence of side effects, such as gastrointestinal symptoms.


2020 ◽  
Vol 10 ◽  
pp. 2235042X2090665
Author(s):  
Jordan Canning ◽  
Stefan Siebert ◽  
Bhautesh D Jani ◽  
Frances S Mair ◽  
Barbara I Nicholl

Background: Rheumatoid arthritis (RA) is a chronic autoimmune disorder characterised by articular inflammation and systemic complications. Multimorbidity (the presence of two or more long-term health conditions) is highly prevalent in people with RA but the effect of multimorbidity on mortality and other health-related outcomes is poorly understood. Objective: To determine what is known about the effect, if any, of multimorbidity on mortality and health-related outcomes in individuals with RA. Design: Systematic review of the literature. The following electronic medical databases will be searched: MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature, PsycINFO, The Cochrane Library and Scopus. Included studies will be quality appraised using the Quality in Prognostic Studies tool developed by the Cochrane Prognosis Methods Group. A narrative synthesis of findings will be undertaken and meta-analyses considered, if appropriate. This protocol adheres to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols 2015 guidelines, ensuring the quality of the review. Conclusions: Understanding the influence of multimorbidity on mortality and other health-related outcomes in RA will provide an important basis of knowledge with the potential to improve future clinical management of RA. PROSPERO registration number: CRD42019137756.


2013 ◽  
Vol 73 (3) ◽  
pp. 595-599 ◽  
Author(s):  
Kazuki Yoshida ◽  
Yoon-Kyoung Sung ◽  
Arthur Kavanaugh ◽  
Sang-Cheol Bae ◽  
Michael E Weinblatt ◽  
...  

ObjectivesWe conducted a systematic review to assess the design and ‘failure definition’ in studies of biologic discontinuation in rheumatoid arthritis (RA).MethodsWe found 403 studies on PubMed, and included nine published papers and five abstracts from scientific meetings. We used a structured extraction form to collect information regarding study design and outcome (failure) definition.ResultsThree types of studies were found: randomised controlled trials, long-term extension studies of clinical trials and prospective discontinuation studies. The largest study had 196 subjects in the discontinuation arm. Most studies allowed concomitant use of non-biologic drugs at biologic discontinuation. Heterogeneity was also found in the failure definition. Although all studies used measures of disease activity, the threshold for failure and the time point of assessment differed among studies. Few studies incorporated changing use of non-biologic drugs or glucocorticoids into the failure definition.ConclusionsAlthough many studies have examined the outcome of biologic discontinuation, they have all been relatively small. Typical practice studies from registries may add important information but will likely need to rely on a broader failure definition.


2014 ◽  
Vol 11 (6) ◽  
pp. 1248-1261 ◽  
Author(s):  
Louise Larkin ◽  
Norelee Kennedy

Background:Physical activity (PA) is an important component in the management of Rheumatoid Arthritis (RA). To date the correlates of PA have not been thoroughly investigated in the RA population. The aim of this systematic review was to determine the correlates of PA in the adult RA population.Methods:A search of Medline, EMBASE, AMED, CINAHL plus, Pubmed, Web of Science, and the Cochrane Library was conducted. A manual search of reference lists was conducted to compliment the electronic search. Ten studies fulfilled the inclusion criteria and were assessed for methodological quality.Results:Results determined correlates in 4 categories: sociodemographic, physical, psychological and social variables. The variables varied greatly and were inconsistently studied. Changes were noted from a previous review in 2005 in relation to the association between certain variables and PA, including age, gender, disease duration, pain, exercise beliefs and social support.Conclusions:Positive associations with PA were found for motivation, self-efficacy, health perception, and previous PA levels. Negative associations were found for fatigue, a coerced regulation style and certain physiological variables. In addition differences between correlates of PA in the adult RA population and other chronic disease and healthy adult populations have been demonstrated.


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