MO840ADAPTIVE DESIGN METHODS IN DIALYSIS CLINICAL TRIALS – A SYSTEMATIC REVIEW

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
Conor Judge ◽  
Robert Murphy ◽  
Catriona Reddin ◽  
Sarah Cormican ◽  
Andrew Smyth ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Kidney Disease ◽  
Full Text ◽  
Adaptive Design ◽  
Design Method ◽  
The United States ◽  
Design Methods ◽  
Lead Author ◽  
Secondary Outcome

Abstract Background and Aims Adaptive design methods are intended to improve efficiency of clinical trials, and relevant to evaluating interventions in dialysis populations. We sought to quantify the use of adaptive design clinical trials in dialysis. Method We completed a full text systematic review and adhered to the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) guidelines. Our review utilised included a novel machine learning classifier and full text systematic review. We searched MEDLINE (Pubmed) and performed a detailed data extraction of trial characteristics and a narrative synthesis of the data. Results 50 studies, available as 66 articles, were included after full text review. 31 studies were conducted in a dialysis population and 23 studies had renal replacement therapy as a primary or secondary outcome. Group sequential designs were the most common type of adaptive design method used in dialysis randomized clinical trials and in general adaptive designs usage is increasing over time. Acute Kidney Injury (AKI) was studied in 27 (54%) of trials, End Stage Kidney Disease (ESKD) was studied in 22 (44%) of trials and Chronic Kidney Disease (CKD) was studied in one trial (2%). The most common country of lead author was the United States of America in n=20 (40%) of studies. 26 (52%) studies were supported by public funding. 41 studies (82%) did not report their adaptive design method in the title or abstract and would not be detected by a standard systematic review involving title and abstract searches. Conclusion Adaptive design methods are infrequently used in dialysis randomized control trials.

scholarly journals Adaptive design methods in dialysis clinical trials – a systematic review

2021 ◽  
Author(s):  
Conor Judge ◽  
Robert Murphy ◽  
Catriona Reddin ◽  
Sarah Cormican ◽  
Andrew Smyth ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Kidney Disease ◽  
Full Text ◽  
Adaptive Design ◽  
Design Method ◽  
Kidney Injury ◽  
Design Methods ◽  
Sequential Designs ◽  
Over Time

AbstractBackgroundAdaptive design methods are intended to improve efficiency of clinical trials and are relevant to evaluating interventions in dialysis populations. We sought to quantify the use of adaptive designs in dialysis clinical trials.MethodsWe completed a full text systematic review and adhered to the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) guidelines. Our review utilised a machine learning classifier and a novel full text systematic review method. We searched MEDLINE (Pubmed) and performed a detailed data extraction of trial characteristics and a completed a narrative synthesis of the data.Results50 studies, available as 66 articles, were included after full text review. 31 studies were conducted in a dialysis population and 19 studies had renal replacement therapy as a primary or secondary outcome. While the absolute number of adaptive design methods is increasing over time, the relative use of adaptive design methods in dialysis trials is decreasing over time (6.1% in 2009 to 0.3% in 2019). Adaptive design methods impacted 52% of dialysis trials they were used in. Group sequential designs were the most common type of adaptive design method used. Acute Kidney Injury (AKI) was studied in 27 trails (54%), End Stage Kidney Disease (ESKD) was studied in 22 trials (44%) and Chronic Kidney Disease (CKD) was studied in 1 trial (2%). 26 studies (52%) were supported by public funding. 41 studies (82%) did not report their adaptive design method in the title or abstract and would not be detected by a standard systematic.ConclusionsAdaptive design methods are employed in dialysis trials, but there has been a decline in their relative use over time.Registration NumberPROSPERO: CRD42020163946Significance statementWhat was previously known about the specific topic of the manuscript?The use of adaptive designs methods in dialysis trials is unquantified.What were the most important findings? If studies are animals, this should be specifiedAlthough absolute numbers of adaptive design trials have increased over time, the proportion of dialysis trials using an adaptive design has reduced. Among trials that employed an adaptive design, 52% of dialysis trials were revised due to the adaptive criteria. Group sequential designs were the most common type of adaptive design method used in dialysis randomized clinical trials. Acute Kidney Injury (AKI) was studied in 54% of trials and End Stage Kidney Disease (ESKD) was studied in 44% of trials, which used an adaptive design.How does the new information advance a new understanding of the kidney and its diseases?Adaptive design methods are effective in dialysis trials, but their relative use has declined over time.

scholarly journals Trends in Adaptive Design Methods in Dialysis Clinical Trials: A Systematic Review

2021 ◽  
Author(s):  
Conor Judge ◽  
Robert Murphy ◽  
Catriona Reddin ◽  
Sarah Cormican ◽  
Andrew Smyth ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Adaptive Design ◽  
Design Methods

scholarly journals Adaptive design methods in dialysis clinical trials: a systematic review protocol

BMJ Open ◽  
2020 ◽  
Vol 10 (8) ◽  
pp. e036755
Author(s):  
Conor Judge ◽  
Robert P Murphy ◽  
Sarah Cormican ◽  
Andrew Smyth ◽  
Martin O'Halloran ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Adaptive Design ◽  
Data Extraction ◽  
Meta Analysis ◽  
Geographical Location ◽  
Cochrane Collaboration ◽  
Design Methods ◽  
Ethical Approval ◽  
Registration Number

IntroductionAdaptive design methods are a potential solution to improve efficiency of clinical trials but their uptake in dialysis is unknown. We aim to investigate the use of adaptive design methods in dialysis clinical trials and to cultivate further adoption of adaptive design methods by the nephrology community.Methods and analysisWe will adhere to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines and the Cochrane Collaboration Handbook. We will perform a literature search through MEDLINE (PubMed), EMBASE and CENTRAL, a detailed data extraction of trial characteristics and a narrative synthesis of the data. There will be no language restrictions. We will estimate the percentage of adaptive clinical trials per year in dialysis. Subgroup analysis will be performed by dialysis modality, funder and geographical location.Ethics and disseminationEthical approval will not be required for this study as data will be obtained from publicly available clinical trials. We will disseminate our results in a peer-reviewed publication.PROSPERO registration number

A Systematic Review on Barriers to Palliative Care in Oncology

2021 ◽  
pp. 104990912098328
Author(s):  
Jyotsana Parajuli ◽  
Judith E. Hupcey
Keyword(s):  
United States ◽  
Systematic Review ◽  
Palliative Care ◽  
Full Text ◽  
Literature Search ◽  
Intervention Development ◽  
The United States ◽  
Care Utilization ◽  
Review Of Literature ◽  
Meta Analyses

The number of people with cancer and the need for palliative care among this population is increasing in the United States. Despite this growing need, several barriers exist to the utilization of palliative care in oncology. The purpose of this study was to synthesize the evidence on the barriers to palliative care utilization in an oncology population. A systematic review of literature was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. PubMed, CINAHL, and Psych Info databases were used for the literature search. Articles were included if they: 1) focused on cancer, (2) examined and discussed barriers to palliative care, and c) were peer reviewed, published in English, and had an accessible full text. A total of 29 studies (8 quantitative, 18 qualitative, and 3 mixed-methods) were identified and synthesized for this review. The sample size of the included studies ranged from 10 participants to 313 participants. The barriers to palliative care were categorized into barriers related to the patient and family, b) barriers related to providers, and c) barriers related to the healthcare system or policy. The factors identified in this review provide guidance for intervention development to mitigate the existing barriers and facilitate the use palliative care in individuals with cancer.

Frontotemporal Dementia: A systematic review

2021 ◽  
Author(s):  
Samar Khalifa
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Frontotemporal Dementia ◽  
Full Text ◽  
Common Type ◽  
Functional Measures ◽  
The Future ◽  
Clinical Measures

Abstract Background: Frontotemporal dementia is a common type of dementia and is a group of progressive neurodegenerative syndromes usually caused by the accumulation of pathological tau or TDP-43 proteins. The review is identifying the clinical measures including neuropsychological scores and functional measures. Methods: A systematic review was conducted covering the clinical trials done to investigate the Frontotemporal Dementia. The sample was taken from Pubmed library. 28 results were found in a range of time from 2016 to 2021. The excluded papers were 17. Results: A total of 10,349 articles were identified at the first stage of papers selecting. All records were screened in order to include and exclude by title/abstract and then based on full text. After excluding articles by year and type of papers, a total of 28 articles were identified through the databases. Following this, the irrelevant papers from databases were removed from original articles, and finally 11 articles were included based on their title/abstract. Full articles were then sourced for about 600 references. It included 732 patients and 195 controls as a total. Conclusions: The review describes the clinical and RCT trials for FTD in the last five years so it can be very updated information for the researchers to cover information required for their researches in the future ones.

scholarly journals P10 Reporting of offspring data in diabetes, HIV infection and hypertension trials during pregnancy: a systematic review

2019 ◽  
Vol 104 (6) ◽  
pp. e21.1-e21
Author(s):  
B Aurich ◽  
T Martin-Montoya ◽  
D Zhang ◽  
E Jacqz-Aigrain
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Hiv Infection ◽  
Pregnant Women ◽  
Health Care Professionals ◽  
Full Text ◽  
Treatment Options ◽  
Safety Data ◽  
Chronic Medication ◽  
Neonatal Deaths

BackgroundAccording to international guidelines clinical trials are conducted during pregnancy to evaluate benefits and risks of medicines for both the mother and her offspring. Consolidated Standards of Reporting Trials (CONSORT) reporting criteria apply to these trials and should include safety data on the offspring. The safety of maternal treatments is a key issue for health care professionals and parents. Diabetes, human immunodeficiency virus (HIV) infection and hypertension are among the most frequent chronic diseases worldwide in women of child bearing potential. The objective of this systematic review was to analyse offspring data reported in clinical trials conducted in pregnant women receiving chronic drug treatment for one of these conditions.MethodsPubmed and Embase (01/01/1997–31/12/2017) were searched for drug trials in pregnant women with diabetes, HIV infection or hypertension. Titles and abstracts were screened, followed by a full text review of eligible articles. Inclusion criteria were interventional clinical trials in pregnant women treated with chronic medication and full text in English. Trial characteristics, maternal and offspring data were extracted. Data was summarised by disease and study. Twelve key items were considered for the offspring. The protocol was registered on PROSPERO (CRD42017057024).ResultsOverall, 196 articles reporting 132 clinical trials (diabetes n=55; HIV n=59; hypertension n=18) were included. The number of births were frequently not reported (diabetes 40%; HIV 24%; hypertension 56%). Congenital malformations were infrequently reported with sufficient detail (diabetes 27%; HIV 34%; hypertension 6%). Similar observations were made for other key items (e.g. foetal losses, neonatal deaths, birth weight corrected for gestational age).ConclusionsUnderreporting of key data for the offspring was frequent in publications of clinical trials in pregnant women with diabetes, HIV infection or hypertension making the assessment of the benefit-risk ratio of treatment options during pregnancy difficult.Disclosure(s)Nothing to disclose

scholarly journals Antidiabetic Drugs in Alzheimer’s Disease and Mild Cognitive Impairment: A Systematic Review

2020 ◽  
pp. 1-12 ◽  
Author(s):  
Mario Muñoz-Jiménez ◽  
Alí Zaarkti ◽  
Juan Antonio García-Arnés ◽  
Natalia García-Casares
Keyword(s):  
Systematic Review ◽  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trials ◽  
Cognitive Impairment ◽  
Mild Cognitive Impairment ◽  
Antidiabetic Drugs ◽  
Secondary Outcome ◽  
Diabetic Patients ◽  
Intranasal Insulin

<b><i>Introduction:</i></b> Considering that Alzheimer’s disease (AD) and diabetes mellitus share pathophysiological features and AD remains with no cure, antidiabetic drugs like intranasal insulin, glitazones, metformin, and liraglutide are being tested as a potential treatment. <b><i>Objective:</i></b> The aim of this systematic review was to assess the efficacy of antidiabetic drugs in patients with AD, mild cognitive impairment (MCI), or subjective cognitive complaints (SCCs). Cognition was studied as the primary outcome and modulation of AD biomarkers, and imaging was also assessed as a secondary outcome. <b><i>Methods:</i></b> We conducted a search in the electronic databases PubMed/MEDLINE, EMBASE, and Scopus seeking clinical trials evaluating the effect on cognition of antidiabetic drugs in patients with AD, MCI, or SCCs. <b><i>Results:</i></b> A total of 23 articles were found eligible. Intranasal regular insulin improved verbal memory in most studies, especially in apoE4− patients, but results in other cognitive domains were unclear. Detemir improved cognition after 2 months of treatment, but it did not after 4 months. Pioglitazone improved cognition in diabetic patients with AD or MCI in 3 clinical trials, but it is controversial as 2 other studies did not show effect. Metformin and liraglutide showed promising results, but further research is needed as just 2 clinical trials involved each of these drugs. Almost all drugs tested were shown to modulate AD biomarkers and imaging. <b><i>Conclusions:</i></b> Intranasal insulin, pioglitazone, metformin, and liraglutide are promising drugs that could be useful in the treatment of AD. However, many questions remain to be answered in future studies, so no particular antidiabetic drug can currently be recommended to treat AD.

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