scholarly journals THE DEFINITION OF PERSISTENT PULMONARY HYPERTENSION OF THE NEWBORN IN RANDOMISED CONTROLLED TRIALS: A SYSTEMATIC LITERATURE REVIEW

Author(s):  
Samantha Slee ◽  
Emily HOYLE
BJPsych Open ◽  
2021 ◽  
Vol 7 (S1) ◽  
pp. S276-S276
Author(s):  
Syed Nabeel Javaid

AimsThe aim of this systematic literature review was to determine the evidence-based effectiveness of animal assisted interventions and to look at the factors that limit implementation of this intervention.BackgroundDementia is a major health issue worldwide impacting not only on the people diagnosed with dementia, but also on their families and caregivers, and the healthcare professionals. The symptoms of dementia include cognitive impairment that can range from mild to severe, and behavioural and psychological symptoms which have debilitating effects on functional capacity and quality of life. A number of non-pharmacological interventions are being developed to help people with dementia. Animal assisted therapy is one of those interventions that has demonstrated positive effects on various aspects of dementia (Filan and Llewellyn-Jones, 2006). However, there are limitations to its use and feasibility of animal assisted therapy programmes is unclear.MethodOnly randomised-controlled trials (RCTs) were to be included to evaluate high quality evidence. A systematic literature search was carried out to find using the PubMed and Cochrane databases and a search of the NICE website. Literature was screened according to inclusion and exclusion criteria. Eight randomised-controlled trials were selected to be used in this systematic review to assess the effectiveness of animal-assisted therapy.ResultThe results regarding the effectiveness of animal assisted therapy were variable. There was some improvement demonstrated in symptoms of depression, agitation, behaviour and cognitive impairment. Quality of life and activities of daily living also demonstrated positive outcomes. There was a reduction in the risk of falls in people with dementia. However, the studies conducted demonstrated limited methodologies. The factors limiting the use of animal assisted therapy were found to be concerns around adverse events to animals, issues of animal welfare and economic feasibility of animal assisted therapy programmes.ConclusionFurther research needs to be done using properly conducted randomised controlled trials with larger sample sizes to formally assess people's perceptions regarding therapy animals and develop clear guidelines and protocols for integrating these interventions in healthcare.


BMJ Open ◽  
2018 ◽  
Vol 8 (9) ◽  
pp. e017240 ◽  
Author(s):  
Jianrong Zhang ◽  
Yiyin Zhang ◽  
Shiyan Tang ◽  
Long Jiang ◽  
Qihua He ◽  
...  

ObjectiveUnbiased assessment of tumour response is crucial in randomised controlled trials (RCTs). Blinded independent central review is usually used as a supplemental or monitor to local assessment but is costly. The aim of this study is to investigate whether systematic bias existed in RCTs by comparing the treatment effects of efficacy endpoints between central and local assessments.DesignLiterature review, pooling analysis and correlation analysis.Data sourcesPubMed, from 1 January 2010 to 30 June 2017.Eligibility criteria for selecting studiesEligible articles are phase III RCTs comparing anticancer agents for advanced solid tumours. Additionally, the articles should report objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS) or time to progression (TTP); the treatment effect of these endpoints, OR or HR, should be based on central and local assessments.ResultsOf 76 included trials involving 45 688 patients, 17 (22%) trials reported their endpoints with statistically inconsistent inferences (p value lower/higher than the probability of type I error) between central and local assessments; among them, 9 (53%) trials had statistically significant inference based on central assessment. Pooling analysis presented no systematic bias when comparing treatment effects of both assessments (ORR: OR=1.02 (95% CI 0.97 to 1.07), p=0.42, I2=0%; DCR: OR=0.97 (95% CI 0.92 to 1.03), p=0.32, I2=0%); PFS: HR=1.01 (95% CI 0.99 to 1.02), p=0.32, I2=0%; TTP: HR=1.04 (95% CI 0.95 to 1.14), p=0.37, I2=0%), regardless of funding source, mask, region, tumour type, study design, number of enrolled patients, response assessment criteria, primary endpoint and trials with statistically consistent/inconsistent inferences. Correlation analysis also presented no sign of systematic bias between central and local assessments (ORR, DCR, PFS: r>0.90, p<0.01; TTP: r=0.90, p=0.29).ConclusionsNo systematic bias could be found between local and central assessments in phase III RCTs on solid tumours. However, statistically inconsistent inferences could be made in many trials between both assessments.


2017 ◽  
Vol 26 (5) ◽  
pp. 425-432 ◽  
Author(s):  
Yitao Zhang ◽  
Weijie Zeng ◽  
Shiyao Cheng ◽  
Zhichong Chen ◽  
Jiaojie Xue ◽  
...  

2021 ◽  
pp. 204589402110180
Author(s):  
Lucilla Piccari ◽  
Roberto J Bernardo ◽  
Diego Rodríguez ◽  
Patrizio Vitulo ◽  
Stephen John Wort ◽  
...  

Dear Editor, We read with great interest the article “Outcomes of pulmonary vasodilator use in Veterans with pulmonary hypertension associated with left heart disease and lung disease” by Gillmeyer et al. The study findings of increased risk of death or organ failure in patients exposed to pulmonary vasodilators, are consistent with findings from randomised clinical trials and other cohort studies and “real-world scenarios”, as quoted by the authors. However, a very important lesson from over two decades of studies is that proper phenotyping of pulmonary vascular disease is key to assess risk of progression of disease. As we progress in the study of these phenotypes, both in Group 2 and Group 3 PH, we might understand which mechanisms produce these subtle but clear differences in response to vasodilator treatment. We fully agree with the authors of the paper that the use of pulmonary vasodilators in Group 2 and Group 3 PH should be confined to randomised-controlled trials, not only in order to gather data on the numerous safety concerns, but also in order to generate new, reliable evidence. We also think that the use of registries will help garner more information on “real-world” scenarios and confirm on retrospective cohorts the results obtained in randomised-controlled trials, provided we are careful to study disease groups and subgroups appropriately, avoiding the temptation of lumping them together in a bigger cohort which will inevitably mixed pears with apples. Furthermore, in full agreement with the recommendations for future directions in research on Group 3 PH, we call for studies that delve deeper into these heterogeneous groups of diseases. After the low-definition group photos, we believe it is time to zoom in the picture to gather a better understanding of what exactly is killing the different subgroups within Group 2 and Group 3 PH patients.


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