Core Data Necessary for Reporting Clinical Trials on Nutrition in Infancy

2014 ◽  
Vol 66 (1) ◽  
pp. 31-35 ◽  
Author(s):  
Berthold Koletzko ◽  
Mary Fewtrell ◽  
Robert Gibson ◽  
Johannes B. van Goudoever ◽  
Olle Hernell ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Infant Nutrition ◽  
Main Body ◽  
Data Set ◽  
Core Data ◽  
Confidential Data ◽  
Previous Proposal ◽  
Meta Analyses ◽  
Made In

This paper presents an updated and revised summary of the ‘core data set' that has been proposed to be recorded and reported in all clinical trials on infant nutrition by the recently formed Consensus Group on Outcome Measures Made in Paediatric Enteral Nutrition Clinical Trials (COMMENT). This core data set was developed based on a previous proposal by the European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) Committee on Nutrition in 2003. It comprises confidential data to identify subjects and facilitate contact for further follow-up, data to characterize the cohort studied and data on withdrawals from the study, and some additional core data for all nutrition studies on preterm infants. We recommend that all studies on nutrition in infancy should collect and report this core data set to facilitate interpretation and comparison of results from clinical studies, and of systematic data evaluation and meta-analyses. Editors of journals publishing such reports are encouraged to require the reporting of the minimum data set described here either in the main body of the publication or as supplementary online material. © 2014 S. Karger AG, Basel

scholarly journals Movement-Evoked Pain Versus Pain at Rest in Postsurgical Clinical Trials and Meta-Analyses: Protocol for a Follow-Up Systematic Review

10.2196/15309 ◽  
2020 ◽  
Vol 9 (1) ◽  
pp. e15309
Author(s):  
Daenis Camiré ◽  
Jason Erb ◽  
Henrik Kehlet ◽  
Timothy Brennan ◽  
Ian Gilron
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Postoperative Pain ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Pain Treatment ◽  
Pain Outcome ◽  
Meta Analyses ◽  
Pain At Rest

Background Postoperative pain is one of the most prevalent and disabling complications of surgery that is associated with personal suffering, delayed functional recovery, prolonged hospital stay, perioperative complications, and chronic postsurgical pain. Accumulating evidence has pointed to the important distinction between pain at rest (PAR) and movement-evoked pain (MEP) after surgery. In most studies including both measures, MEP has been shown to be substantially more severe than PAR. Furthermore, as MEP is commonly experienced during normal activities (eg, breathing, coughing, and walking), it has a greater adverse functional impact than PAR. In a previous systematic review conducted in 2011, only 39% of reviewed trials included MEP as a trial outcome and 52% failed to identify the pain outcome as either PAR or MEP. Given the recent observations of postsurgical pain trials that continue to neglect the distinction between PAR and MEP, this updated review seeks to evaluate the degree of progress in this area. Objective This updated review will include postsurgical clinical trials and meta-analyses in which the primary outcome was early postoperative pain intensity. The primary outcome for this review is the reporting of MEP (vs PAR) as an outcome measure for each trial and meta-analysis. Secondary outcomes include whether trials and meta-analyses distinguished between PAR and MEP. Methods To be consistent with the 2011 review that we are updating, this review will again focus on randomized controlled trials and meta-analyses, from Medical Literature Analysis and Retrieval System Online and EMBASE databases, focusing on pain treatment after thoracotomy, knee arthroplasty, and hysterectomy in humans. Trials and meta-analyses will be characterized as to whether or not they assessed PAR and MEP; whether their pain outcome acknowledged the distinction between PAR and MEP; and, for trials assessing MEP, which pain-evoking maneuver(s) were used. Results Scoping review and pilot data extraction are under way, and the results are expected by March 2020. Conclusions It is our belief that every postsurgical analgesic trial should include MEP as an outcome measure. The previous 2011 review was expected to have an impact on more widespread assessment of MEP in subsequent postoperative pain treatment trials. Thus, the purpose of this follow-up review is to reevaluate the frequency of use of MEP as a trial outcome, compared with PAR, in more recently published postoperative pain trials. Trial Registration PROSPERO CRD42019125855; https://tinyurl.com/qw9dty8 International Registered Report Identifier (IRRID) DERR1-10.2196/15309

scholarly journals Mutation in ROBO3 Gene in Patients with Horizontal Gaze Palsy with Progressive Scoliosis Syndrome: A Systematic Review

2020 ◽  
Vol 17 (12) ◽  
pp. 4467
Author(s):  
Elena Pinero-Pinto ◽  
Verónica Pérez-Cabezas ◽  
Cristina Tous-Rivera ◽  
José-María Sánchez-González ◽  
Carmen Ruiz-Molinero ◽  
...  
Keyword(s):  
Systematic Review ◽  
Rapid Progression ◽  
Childhood And Adolescence ◽  
Progressive Scoliosis ◽  
Chromosome 11Q23 ◽  
Horizontal Gaze ◽  
Meta Analyses ◽  
Gaze Palsy ◽  
Made In

Horizontal gaze palsy with progressive scoliosis (HGPPS) is a rare, inherited disorder characterized by a congenital absence of conjugate horizontal eye movements with progressive scoliosis developing in childhood and adolescence. Mutations in the Roundabout (ROBO3) gene located on chromosome 11q23–25 are responsible for the development of horizontal gaze palsy and progressive scoliosis. However, some studies redefined the locus responsible for this pathology to a 9-cM region. This study carried out a systematic review in which 25 documents were analyzed, following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) standards. The search was made in the following electronic databases from January 1995 to October 2019: PubMed, Scopus, Web of Science, PEDRO, SPORT Discus, and CINAHL. HGPPS requires a multidisciplinary diagnostic approach, in which magnetic resonance imaging might be the first technique to suggest the diagnosis, which should be verified by an analysis of the ROBO3 gene. This is important to allow for adequate ocular follow up, apply supportive therapies to prevent the rapid progression of scoliosis, and lead to appropriate genetic counseling.

scholarly journals Composite Indices Using 3 or 4 Components of the Core Data Set Have Similar Predictive Ability to Measure Disease Activity in RA: Evidence from the DANCER and REFLEX Studies

2013 ◽  
Vol 2013 ◽  
pp. 1-7 ◽  
Author(s):  
Martin J. Bergman ◽  
William Reiss ◽  
Carol Chung ◽  
Pamela Wong ◽  
Adam Turpcu
Keyword(s):  
Clinical Trials ◽  
Assessment Tool ◽  
Predictive Ability ◽  
Disease Assessment ◽  
Control Treatment ◽  
Routine Practice ◽  
Data Set ◽  
Study Objective ◽  
Core Data ◽  
Composite Indices

Background. Understanding how disease-assessment indices perform in rheumatoid arthritis (RA) clinical trials can inform their use in routine practice. The study objective was to assess the capacity of combinations of RA Core Data Set measures to distinguish rituximab from control treatment.Methods. Post hoc analysis of two randomised clinical trials was used. Composite Efficacy Indices were derived by combining three or four RA Core Data Set measures from three possible sources: physician, patient, and laboratory.Results. All 105 Composite Efficacy Indices evaluated significantly distinguished rituximab from control treatment (P<10−7). Generally, indices containing measures from three different sources had a greater capacity to distinguish rituximab from control treatment than indices containing three measures from one source. Composite Efficacy Indices performed as well as validated indices such as DAS28, RAPID3, and CDAI.Conclusions. All indices composed of three or four RA Core Data Set measures have a similar capacity to detect treatment differences. These results suggest that the precise measurement used is less important than whether any measurement is performed, although selection should be consistent for each patient. Therefore, the choice of assessment tool should not be limited to a prescribed list and should instead be left to the clinician’s discretion.

Are Maternal Genitourinary Infection and Pre-Eclampsia Associated With ADHD in School-Aged Children?

2010 ◽  
Vol 15 (8) ◽  
pp. 667-673 ◽  
Author(s):  
Joshua R. Mann ◽  
Suzanne McDermott
Keyword(s):  
Urinary Tract Infection ◽  
South Carolina ◽  
Billing Data ◽  
Data Set ◽  
School Aged Children ◽  
Increased Risk ◽  
Nongonococcal Urethritis ◽  
Genitourinary Infection ◽  
Made In

Objective: To investigate the hypothesis that maternal genitourinary infection (GU) infection is associated with increased risk of ADHD. Method: The authors obtained linked Medicaid billing data for pregnant women and their children in South Carolina, with births from 1996 through 2002 and follow-up data through 2008. Maternal GU infections and pre-eclampsia were identified on the basis of diagnoses made during pregnancy, and cases of ADHD were identified on the basis of diagnoses made in the child’s Medicaid file. Results: There were 84,721 children in the data set used for analyses. Maternal genitourinary infection was associated with significantly increased odds of ADHD (OR = 1.29, 95% CI = 1.23-1.35). Pre-eclampsia was also associated with increased risk (OR = 1.19, 95% CI = 1.07-1.32). Children whose mothers had both GU infection and pre-eclampsia were 53% more likely to have ADHD, compared to those with neither exposure. When we examined specific infection diagnoses, chlamydia/nongonococcal urethritis, trichomoniasis, urinary tract infection, and candidiasis were associated with increased risk of ADHD, whereas gonorrhea was not. Discussion: Maternal GU infection appeared to be associated with increased risk of ADHD, and based on the findings it was concluded that further research is needed to describe the mechanism(s) underlying the association.

scholarly journals Movement-Evoked Pain Versus Pain at Rest in Postsurgical Clinical Trials and Meta-Analyses: Protocol for a Follow-Up Systematic Review (Preprint)

2019 ◽  
Author(s):  
Daenis Camiré ◽  
Jason Erb ◽  
Henrik Kehlet ◽  
Timothy Brennan ◽  
Ian Gilron
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Postoperative Pain ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Pain Treatment ◽  
Pain Outcome ◽  
Meta Analyses ◽  
Pain At Rest

BACKGROUND Postoperative pain is one of the most prevalent and disabling complications of surgery that is associated with personal suffering, delayed functional recovery, prolonged hospital stay, perioperative complications, and chronic postsurgical pain. Accumulating evidence has pointed to the important distinction between pain at rest (PAR) and movement-evoked pain (MEP) after surgery. In most studies including both measures, MEP has been shown to be substantially more severe than PAR. Furthermore, as MEP is commonly experienced during normal activities (eg, breathing, coughing, and walking), it has a greater adverse functional impact than PAR. In a previous systematic review conducted in 2011, only 39% of reviewed trials included MEP as a trial outcome and 52% failed to identify the pain outcome as either PAR or MEP. Given the recent observations of postsurgical pain trials that continue to neglect the distinction between PAR and MEP, this updated review seeks to evaluate the degree of progress in this area. OBJECTIVE This updated review will include postsurgical clinical trials and meta-analyses in which the primary outcome was early postoperative pain intensity. The primary outcome for this review is the reporting of MEP (vs PAR) as an outcome measure for each trial and meta-analysis. Secondary outcomes include whether trials and meta-analyses distinguished between PAR and MEP. METHODS To be consistent with the 2011 review that we are updating, this review will again focus on randomized controlled trials and meta-analyses, from Medical Literature Analysis and Retrieval System Online and EMBASE databases, focusing on pain treatment after thoracotomy, knee arthroplasty, and hysterectomy in humans. Trials and meta-analyses will be characterized as to whether or not they assessed PAR and MEP; whether their pain outcome acknowledged the distinction between PAR and MEP; and, for trials assessing MEP, which pain-evoking maneuver(s) were used. RESULTS Scoping review and pilot data extraction are under way, and the results are expected by March 2020. CONCLUSIONS It is our belief that every postsurgical analgesic trial should include MEP as an outcome measure. The previous 2011 review was expected to have an impact on more widespread assessment of MEP in subsequent postoperative pain treatment trials. Thus, the purpose of this follow-up review is to reevaluate the frequency of use of MEP as a trial outcome, compared with PAR, in more recently published postoperative pain trials. CLINICALTRIAL PROSPERO CRD42019125855; https://tinyurl.com/qw9dty8 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/15309

scholarly journals Marine n-3 fatty acids and CVD: new insights from recent follow-up studies and clinical supplementation trials

2020 ◽  
Vol 79 (4) ◽  
pp. 428-434 ◽  
Author(s):  
Christian S. Bork ◽  
Linda T. Mortensen ◽  
Katrin Hjelmgaard ◽  
Erik B. Schmidt
Keyword(s):  
Clinical Trials ◽  
Fish Oil ◽  
Meta Analysis ◽  
High Dose ◽  
Large Clinical Trial ◽  
Fatty Fish ◽  
Beneficial Effects ◽  
Follow Up Studies ◽  
Meta Analyses

Marine n-3 PUFA exert beneficial effects that might inhibit atherosclerosis and reduce vascular disease. Previous studies have, however, reported conflicting results and here we have summarised the early history and the most recent findings from follow-up studies and randomised clinical trials investigating marine n-3 PUFA in relation to the risk of atherosclerotic CVD. Most follow-up studies have suggested that the intake of marine n-3 PUFA may be associated with a lower risk of CVD. Recent studies have also shown that it is important to focus on substitution issues and dietary patterns. Further, the use of gold standard biomarkers of fatty acid exposure such as adipose tissue should be encouraged. Findings from clinical supplemental trials have shown conflicting results and findings from previous meta-analyses and guidelines have generally not supported the use of fish oil supplements for the prevention of CVD. However, a recent meta-analysis including three recent large clinical trials with fish oil supplements reported a moderate beneficial effect on cardiovascular endpoints. Interestingly, results from a large clinical trial (REDUCE-IT) have suggested that supplementation with a high dose of purified EPA ethyl ester for 4⋅9 years significantly and markedly reduced the risk of cardiovascular events in patients with CVD and mild hypertriglyceridaemia; findings that need to be confirmed. While it seems appropriate to recommend consumption of fish, particular fatty fish for prevention of CVD, an effect of fish oil supplements is probably at best marginal perhaps apart from patients with hypertriglyceridaemia.

scholarly journals Association Between Disease-Free Survival and Overall Survival When Survival Is Prolonged After Recurrence in Patients Receiving Cytotoxic Adjuvant Therapy for Colon Cancer: Simulations Based on the 20,800 Patient ACCENT Data Set

2010 ◽  
Vol 28 (3) ◽  
pp. 460-465 ◽  
Author(s):  
Aimery de Gramont ◽  
Joleen Hubbard ◽  
Qian Shi ◽  
Michael J. O'Connell ◽  
Marc Buyse ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Overall Survival ◽  
Clinical Trials ◽  
Disease Free Survival ◽  
Cancer Clinical Trials ◽  
Data Set ◽  
Free Survival ◽  
Disease Free ◽  
Extended Survival

Purpose We previously validated disease-free survival (DFS) as a surrogate for overall survival (OS) in fluorouracil-based adjuvant colon cancer clinical trials. New therapies have extended survival after recurrence from 1 to approximately 2 years. We examined the possible impact of this improvement on the DFS/OS association. Methods The Adjuvant Colon Cancer Endpoints (ACCENT) data set of 20,898 patients was analyzed. In an exploratory fashion, time from recurrence to death in patients experiencing recurrence was extended using several algorithms, and the association of DFS after 3 years of median follow-up and OS after varying lengths of follow-up (median of 5, 6, and 7 years) was assessed. Results Seven thousand four hundred two patients (35%) experienced recurrence. Median time from recurrence to death was 24 months in the hypothetical data sets. When times from recurrence to death were doubled, the association between treatment effects on DFS and 5-year OS was modest (R2 = 0.51 for both 2- and 3-year DFS) but remained strong for DFS and 6-year OS (R2 = 0.67 for both 2- and 3-year DFS) and 7-year OS (R2 = 0.70 for both 2- and 3-year DFS). The reduced DFS/OS association with extended survival after recurrence was greater in stage II than stage III patients. Multiple simulations provided consistent findings. Conclusion Extended survival after recurrence reduces the association between treatment effects on 3-year DFS and 5-year OS, particularly in stage II patients; longer follow-up strengthens the association. In modern adjuvant trials, 6 or 7 years may be required to demonstrate OS improvements, further supporting DFS as the preferred primary end point for future adjuvant colon cancer clinical trials.

Postamputation Residual Limb Pain Severity and Prevalence: A Systematic Review and Meta-Analysis

2021 ◽  
pp. 229255032110196
Author(s):  
Adam G. Evans ◽  
Sara C. Chaker ◽  
Gabrielle E. Curran ◽  
Mauricio A. Downer ◽  
Patrick E. Assi ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Pain Severity ◽  
Residual Limb ◽  
Limb Pain ◽  
Residual Limb Pain ◽  
Pain Prevalence ◽  
Meta Analyses ◽  
Extremity Amputation

Background: Individuals with an extremity amputation are predisposed to persistent pain that reduces their quality of life. Residual limb pain is defined as pain that is felt in the limb after amputation. Methods: A Preferred Reporting Items for Systematic Reviews and Meta-Analyses-compliant systematic review of 5 databases from inception to June 2020 was performed and is registered under the PROSPERO ID: CRD42020199297. Included studies were clinical trials with residual limb pain assessed at a minimum follow-up of 1 week. Meta-analyses of residual limb pain prevalence and severity were performed with subgroups of extremity and amputation etiology. Results: Twenty clinical trials met criteria and reported on a total of 1347 patients. Mean patient ages ranged from 38 to 77. Residual limb pain prevalence at 1 week, 1 month, 3 months, 6 months, 1 year, and 2 years, respectively, was 50%, 11%, 23%, 27%, 22%, and 24%. Mean residual limb pain severity at the 6 months or longer follow-up was 4.19 out of 10 for cancer amputations, 2.70 for traumatic amputations, 0.47 for vasculopathy amputations, 1.01 for lower extremity amputations, and 3.56 for upper extremity amputations. Conclusions: Residual limb pain severity varies according to the etiology of amputation and is more common after upper extremity amputation than lower extremity amputations. The most severe pain is reported by patients undergoing amputations due to cancer, followed by traumatic amputations, while vascular amputation patients report lower pain severity. Promising methods of reducing long-term pain are preoperative pain control, nerve or epidural blocks, use of memantine, calcitonin-containing blocks, and prophylactic nerve coaptations.

scholarly journals Effectiveness of Medicinal Plants for Glycaemic Control in Type 2 Diabetes: An Overview of Meta-Analyses of Clinical Trials

2021 ◽  
Vol 12 ◽  
Author(s):  
Merlin L. Willcox ◽  
Christina Elugbaju ◽  
Marwah Al-Anbaki ◽  
Mark Lown ◽  
Bertrand Graz
Keyword(s):  
Type 2 Diabetes ◽  
Clinical Trials ◽  
Glycaemic Control ◽  
Medicinal Plants ◽  
Aloe Vera ◽  
Herbal Medicines ◽  
Herbal Remedies ◽  
Meta Analyses

Aims: To rank the effectiveness of medicinal plants for glycaemic control in Type 2 Diabetes (T2DM).Methods: MEDLINE, EMBASE, CINAHL and Cochrane Central were searched in October 2020. We included meta-analyses of randomised controlled clinical trials measuring the effectiveness of medicinal plants on HbA1c and/or Fasting Plasma Glucose (FPG) in patients with T2DM.Results: Twenty five meta-analyses reported the effects of 18 plant-based remedies. Aloe vera leaf gel, Psyllium fibre and Fenugreek seeds had the largest effects on HbA1c: mean difference –0.99% [95% CI−1.75, −0.23], −0.97% [95% CI −1.94, −0.01] and −0.85% [95% CI −1.49, −0.22] respectively. Four other remedies reduced HbA1c by at least 0.5%: Nigellasativa, Astragalus membranaceus, and the traditional Chinese formulae Jinqi Jiangtang and Gegen Qinlian. No serious adverse effects were reported. Several other herbal medicines significantly reduced FPG. Tea and tea extracts (Camellia sinensis) were ineffective. However, in some trials duration of follow-up was insufficient to measure the full effect on HbA1c (&lt;8 weeks). Many herbal remedies had not been evaluated in a meta-analysis.Conclusion: Several medicinal plants appear to be as effective as conventional antidiabetic treatments for reducing HbA1c. Rigorous trials with at least 3 months’ follow-up are needed to ascertain the effects of promising plant-based preparations on diabetes.

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