Dietary Methodology and Applied Food Composition Data: Producing High-Quality Data in Food-Based Randomized Controlled Trials

With solid tumor cancer survivorship increasing, the number of patients requiring post-treatment surveillance also continues to increase. This highlights the need for evidence-based cancer surveillance guidelines. Ideally, these guidelines would be based on combined high-quality data from randomized controlled trials (RCTs). We present a systematic review of published cancer surveillance RCTs in which we sought to determine the feasibility of data pooling for guideline development. We carried out a systematic search of medical databases for RCTs in which adult patients with solid tumors that had undergone surgical resection with curative intent and had no metastatic disease at presentation, were randomized to different surveillance regimens that assessed effectiveness on overall survival (OS). We extracted study characteristics and primary and secondary outcomes, and assessed risk of bias and validity of evidence with standardized checklist tools. Our search yielded 32,216 articles for review and 18 distinct RCTs were included in the systematic review. The 18 trials resulted in 23 comparisons of surveillance regimens. There was a highlevel of variation between RCTs, including the study populations evaluated, interventions assessed and follow-up periods for the primary outcome. Most studies evaluated colorectal cancer patients (11/18, [61%]). The risk of bias and validity of evidence were variable and inconsistent across studies. This review demonstrated that there is tremendous heterogeneity among RCTs that evaluate effectiveness of different postoperative surveillance regimens in cancer patients, rendering the consolidation of data to inform high-quality cancer surveillance guidelines unfeasible. Future RCTs in the field should focus on consistent methodology and primary outcome definition.

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Food Composition at Present: New Challenges

Nutrients ◽

10.3390/nu11081714 ◽

2019 ◽

Vol 11 (8) ◽

pp. 1714 ◽

Cited By ~ 5

Author(s):

Maria Kapsokefalou ◽

Mark Roe ◽

Aida Turrini ◽

Helena S. Costa ◽

Emilio Martinez-Victoria ◽

...

Keyword(s):

Food Composition ◽

Quality Data ◽

Nutrition And Health ◽

High Quality ◽

Composition Data ◽

Research Infrastructures ◽

Food Composition Data ◽

New Challenges ◽

Food Nutrition ◽

The Mediterranean

Food composition data is important for stakeholders and users active in the areas of food, nutrition and health. New challenges related to the quality of food composition data reflect the dynamic changes in these areas while the emerging technologies create new opportunities. These challenges and the impact on food composition data for the Mediterranean region were reviewed during the NUTRIMAD 2018 congress of the Spanish Society for Community Nutrition. Data harmonization and standardization, data compilation and use, thesauri, food classification and description, and data exchange are some of the areas that require new approaches. Consistency in documentation, linking of information between datasets, food matching and capturing portion size information suggest the need for new automated tools. Research Infrastructures bring together key data and services. The delivery of sustainable networks and Research Infrastructures in food, nutrition and health will help to increase access to and effective use of food composition data. EuroFIR AISBL coordinates experts and national compilers and contributes to worldwide efforts aiming to produce and maintain high quality data and tools. A Mediterranean Network that shares high quality food composition data is vital for the development of ambitious common research and policy initiatives in support of the Mediterranean Diet.

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Head-to-head comparison of biological drugs for inflammatory bowel disease: from randomized controlled trials to real-world experience

Therapeutic Advances in Gastroenterology ◽

10.1177/17562848211010668 ◽

2021 ◽

Vol 14 ◽

pp. 175628482110106

Author(s):

Fabio Salvatore Macaluso ◽

Marcello Maida ◽

Mauro Grova ◽

Federica Crispino ◽

Giulia Teresi ◽

...

Keyword(s):

Inflammatory Bowel Disease ◽

Randomized Controlled Trials ◽

Real World ◽

Bowel Disease ◽

Quality Data ◽

Controlled Trials ◽

Randomized Controlled ◽

Therapeutic Algorithms ◽

Inflammatory Bowel

During past years, the increasing knowledge of molecular mechanisms of inflammatory bowel disease (IBD) have led to the development of several targeted biological therapies. This great expansion of available medical options has prompted the need for comparative data between drugs. For years, given that most randomized controlled trials (RCTs) were performed only versus placebo, this demand has clashed with the absence of head-to-head trials comparing two or more treatments. The quality of evidence coming from real-world experience was low overall, so it was extremely difficult to clarify the correct positioning of the biologicals inside the therapeutic algorithms for IBD. Fortunately, times are changing: head-to-head comparative RCTs have been conducted or are ongoing, and the methodological quality of real-world studies is gradually increasing, mainly thanks to a higher rate of application of statistical methods capable of reducing the selection bias, such as the propensity score. In this evolving scenario, the increasing number of comparative RCTs is providing high-quality data for a correct drug positioning in IBD. In parallel, real-world observational studies are supporting the data coming from RCTs, and covering those comparisons not performed in the RCT setting. We believe that there is moderate evidence already available to support clinicians in the correct choice between different biologicals, and data will certainly be more robust in the near future.

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Critical analysis of the drafting of physical therapy randomized controlled trials published in Portuguese

Fisioterapia em Movimento ◽

10.1590/0103-5150.029.002.ao21 ◽

2016 ◽

Vol 29 (2) ◽

pp. 421-427

Author(s):

Ercole da Cruz Rubini ◽

Fabio Dutra Pereira ◽

Renato Sobral Monteiro-Junior ◽

Patricia Zaidan ◽

Cintia Pereira de Souza ◽

...

Keyword(s):

Physical Therapy ◽

Randomized Controlled Trials ◽

Gold Standard ◽

Critical Analysis ◽

Physical Therapists ◽

Controlled Trials ◽

High Quality ◽

Randomized Controlled ◽

Methodological Procedures

Abstract Introduction: randomized controlled trials are high quality studies. Many problems related to the drafting of these studies have been identified and consequently various national and international journals, in an attempt to improve this writing, have adopted the Consolidated Standards of Reporting Trials recommendations. Regarding the studies written specifically by physical therapists, until now, the quality of the drafting in Portuguese has been unknown. Aim: To critically analyze the drafting of RCTs in the area of physical therapy, published in Portuguese, in relation to the CONSORT recommendations. Materials and Methods: On 17th Oct, 2012, 548 RCTs in Portuguese were recovered from the MEDLINE and PEDro databases, which were divided among four evaluators who, after reading the abstracts, selected those related to physical therapy. Of these studies, 78 RCTs were related to physical therapy, which were divided among the four evaluators for the analysis of the drafting according to the CONSORT recommendations. The four evaluators who participated in this study previously obtained a median kappa above 70% when their analyses were compared to the analyses of the evaluator considered the gold standard due to having greater experience. Results: The quantity of items of the CONSORT recommendations according to year of publication was very small, corresponding to a mean of 43% of the items in the articles analyzed. Conclusion: The results make very clear the need to improve the quality of the drafting of the RCTs related to physical therapy in Portuguese and to include more rigorous methodological procedures, such as sample size, randomization and blinding. The dissemination and adoption of the CONSORT recommendations by physical therapy researchers would, without doubt, be a big step towards improving this quality.

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Assessment of the content reporting for therapeutic exercise interventions among existing randomized controlled trials on knee osteoarthritis

Clinical Rehabilitation ◽

10.1177/0269215518763714 ◽

2018 ◽

Vol 32 (7) ◽

pp. 980-984 ◽

Cited By ~ 11

Author(s):

Jennifer O’Neil ◽

Daniel McEwen ◽

Michael J Del Bel ◽

Donguk Jo ◽

Odette Thevenot ◽

...

Keyword(s):

Knee Osteoarthritis ◽

Randomized Controlled Trials ◽

Sports Medicine ◽

Intraclass Correlation ◽

Controlled Trials ◽

Quality Of Reporting ◽

High Quality ◽

Exercise Interventions ◽

Randomized Controlled ◽

Standardized Reporting

Purpose/Rationale: Physical exercise interventions for the management of knee osteoarthritis are well known to be effective and accessible forms of rehabilitation and symptom management. However, without adequate reporting of these interventions, accurate replication and clinical use is negatively impacted. Objectives: The main objective of this article was to assess content reporting using The Consensus on Exercise Reporting Template list and 2016 American College of Sports Medicine guidelines among moderate- to high-quality exercise interventions randomized controlled trials (total score of ≥6/10 on the PEDro scale) involving individuals with knee osteoarthritis. Results: The Consensus on Exercise Reporting Template mean total score for all 47 included randomized controlled trials was 4.42 out of 19, demonstrating generally low quality of reporting. The Consensus on Exercise Reporting Template list and the 2016 American College of Sports Medicine guidelines scores were moderately correlated (based on 95% confidence interval, intraclass correlation coefficient = 0.508) for aerobic interventions only. Conclusion: The content analysis of exercise interventions in knee osteoarthritis demonstrated low scores for moderate- to high-quality trials. Improved standardized reporting is recommended to ensure knowledge transfer and replication of effective exercise programs for individuals with knee osteoarthritis.

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High-Quality Randomized Controlled Trials in Pediatric Critical Care

Pediatric Critical Care Medicine ◽

10.1097/pcc.0000000000001144 ◽

2017 ◽

Vol 18 (5) ◽

pp. 405-413 ◽

Cited By ~ 13

Author(s):

Mark Duffett ◽

Karen Choong ◽

Jennifer Foster ◽

Maureen Meade ◽

Kusum Menon ◽

...

Keyword(s):

Critical Care ◽

Randomized Controlled Trials ◽

Controlled Trials ◽

High Quality ◽

Pediatric Critical Care ◽

Randomized Controlled

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Efficacy and Safety of Fuzi Formulae on the Treatment of Heart Failure as Complementary Therapy: A Systematic Review and Meta-Analysis of High-Quality Randomized Controlled Trials

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2019/9728957 ◽

2019 ◽

Vol 2019 ◽

pp. 1-21

Author(s):

Meng-Qi Yang ◽

Yong-Mei Song ◽

Huan-Yu Gao ◽

Yi-Tao Xue

Keyword(s):

Heart Failure ◽

Randomized Controlled Trials ◽

Meta Analysis ◽

Risk Of Bias ◽

Controlled Trials ◽

Efficacy And Safety ◽

High Quality ◽

Randomized Controlled ◽

Link Type

Objective. Heart failure is a major public health problem worldwide nowadays. However, the morbidity, mortality, and awareness of heart failure are not satisfied as well as the status of current treatments. According to the standard treatment for chronic heart failure (CHFST), Fuzi (the seminal root of Aconitum carmichaelii Debx.) formulae are widely used as a complementary treatment for heart failure in clinical practice for a long time. We are aiming to assess the efficacy and safety of Fuzi formulae (FZF) on the treatment of heart failure according to high-quality randomized controlled trials (RCTs). Methods. RCTs in PubMed, Cochrane Library, China National Knowledge Infrastructure (CNKI), Chinese Scientific Journals Database (VIP), and Wanfang Database were searched from their inception until June 2019. In addition, the U.S. National Library of Medicine (clinicaltrials.gov) and the Chinese Clinical Trial Registry (http://www.chictr.org.cn) were also searched. We included RCTs that test the efficacy and safety of FZF for the treatment of heart failure, compared with placebo, CHFST, or placebo plus CHFST. The methodological quality of included studies were evaluated by the Cochrane Collaboration’s tool for assessing risk of bias. RCTs with Cochrane risk of bias (RoB) score ≥4 were included in the analysis. The meta-analysis was conducted through RevMan 5.2 software. The GRADE approach was used to assess the quality of the evidence. Results. Twelve RCTs with 1490 participants were identified. The studies investigated the efficacy and safety of FZF, such as FZF plus the CHFST vs placebo plus CHFST (n = 4), FZF plus CHFST vs CHFST (n = 6), FZF plus digoxin tablets (DT) plus CHFST vs placebo plus DT plus CHFST (n = 1), and FZF plus placebo plus CHFST vs placebo plus DT plus CHFST (n = 1). Meta-analysis indicated that FZF have additional benefits based on the CHFST in reducing plasma NT-proBNP level, MLHFQ scores, Lee’s heart failure scores (LHFs), and composite cardiac events (CCEs). Meanwhile, it also improved the efficacy on TCM symptoms (TCMs), NYHA functional classification (NYHAfc), 6MWD, and LVEF. Adverse events were reported in 6 out of 12 studies without significant statistical difference. However, after assessing the strength of evidence, it was found that only the quality of evidence for CCEs was high, and the others were either moderate or low or very low. So we could not draw confirmative conclusions on its additional benefits except CCEs. Further clinical trials should be well designed to avoid the issues that were identified in this study. Conclusion. The efficacy and additional benefits of FZF for CCEs were certain according to the high-quality evidence assessed through GRADE. However, the efficacy and additional benefits for the other outcomes were uncertain judging from current studies. In addition, the safety assessment has a great room for improvement. Thus, further research studies are needed to find more convincing proofs.

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Effects of Angiotensin-Converting Enzyme Inhibitors on Arterial Stiffness: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Cardiovascular Therapeutics ◽

10.1155/2020/7056184 ◽

2020 ◽

Vol 2020 ◽

pp. 1-12 ◽

Cited By ~ 1

Author(s):

Xiuli Li ◽

Peng Chang ◽

Qiongying Wang ◽

Hao Hu ◽

Feng Bai ◽

...

Keyword(s):

Blood Pressure ◽

Arterial Stiffness ◽

Randomized Controlled Trials ◽

Antihypertensive Drugs ◽

Meta Analysis ◽

Cochrane Library ◽

Controlled Trials ◽

High Quality ◽

Randomized Controlled ◽

And Control

To determine the effects of ACEIs on arterial stiffness, a meta-analysis of randomized controlled trials was conducted. Relevant articles that investigated the effects of ACEIs on arterial stiffness from PubMed, Embase, and the Cochrane library from inception to September 2018 were systematically retrieved. The investigated outcomes included brachial-ankle pulse wave velocity (ba-PWV) and carotid-femoral PWV (cf-PWV) by using weighted mean differences (WMDs) and 95% confidence intervals (CIs) with the random-effects model. A total of 17 RCTs including 1,458 individuals were included. The summary results indicated no significant differences between ACEIs and control for ba-PWV and cf-PWV. Also, no significant differences between ACEI and control for ba-PWV and cf-PWV were observed in hypertensive patients, while the therapeutic effects of ACEI versus placebo showed statistically significant difference. Moreover, subgroup analysis indicated that the levels of ba-PWV were significantly associated if the study was conducted in Western countries, mean age <60.0 years, percentage male ≥60.0%, compared with ARBs, baseline PWV <10.0, and high-quality study. Furthermore, the significant levels of cf-PWV in patients who received ACEIs were observed when percentage male was ≥60.0% and the studies were of high-quality. Finally, no significant differences were observed between ACEIs and other antihypertensive drugs regarding the changes of systolic blood pressure (SBP) and diastolic blood pressure (DBP). The overall analysis suggested no significant differences between ACEIs and other antihypertensive drugs for ba-PWV and cf-PWV levels, whereas ACEIs versus placebo showed lower levels of ba-PWV and cf-PWV.

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