Dataset Information

Randomized controlled trials of malaria intervention trials in Africa, 1948 to 2007: a descriptive analysis.

ABSTRACT:

Background

Nine out of ten deaths from malaria occur in sub-Saharan Africa. Various control measures have achieved some progress in the control of the disease, but malaria is still a major public health problem in Africa. Randomized controlled trials (RCTs) are universally considered the best study type to rigorously assess whether an intervention is effective. The study reported here provides a descriptive analysis of RCTs reporting interventions for the prevention and treatment of malaria conducted in Africa, with the aim of providing detailed information on their main clinical and methodological characteristics, that could be used by researchers and policy makers to help plan future research.

Methods

Systematic searches for malaria RCTs were conducted using electronic databases (Medline, Embase, the Cochrane Library), and an African geographic search filter to identify RCTs conducted in Africa was applied. Results were exported to the statistical package STATA 8 to obtain a random sample from the overall data set. Final analysis of trial characteristics was done in a double blinded fashion by two authors using a standardized data extraction form.

Results

A random sample of 92 confirmed RCTs (from a total of 943 reports obtained between 1948 and 2007) was prepared. Most trials investigated drug treatment in children with uncomplicated malaria. Few trials reported on treatment of severe malaria or on interventions in pregnant women. Most trials were of medium size (100-500 participants), individually randomized and based in a single centre. Reporting of trial quality was variable. Although three-quarter of trials provided information on participants' informed consent and ethics approval, more details are needed.

Conclusions

The majority of malaria RCT conducted in Africa report on drug treatment and prevention in children; there is need for more research done in pregnant women. Sources of funding, informed consent and trial quality were often poorly reported. Overall, clearer reporting of trials is needed.

SUBMITTER: Lutje V

PROVIDER: S-EPMC3064642 | biostudies-literature | 2011 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Randomized controlled trials of malaria intervention trials in Africa, 1948 to 2007: a descriptive analysis.

Lutje Vittoria V Gerritsen Annette A Siegfried Nandi N

Malaria journal 20110315

<h4>Background</h4>Nine out of ten deaths from malaria occur in sub-Saharan Africa. Various control measures have achieved some progress in the control of the disease, but malaria is still a major public health problem in Africa. Randomized controlled trials (RCTs) are universally considered the best study type to rigorously assess whether an intervention is effective. The study reported here provides a descriptive analysis of RCTs reporting interventions for the prevention and treatment of mala ...[more]

PMID: 21406113

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Project description:BackgroundThe objective of this study was to describe randomized controlled trials (RCTs) and controlled clinical trials (CCTs) in child health published between 1948 and 2006, in terms of quantity, methodological quality, and publication and trial characteristics. We used the Trials Register of the Cochrane Child Health Field for overall trends and a sample from this to explore trial characteristics in more detail.Methodology/principal findingsWe extracted descriptive data on a random sample of 578 trials. Ninety-six percent of the trials were published in English; the percentage of child-only trials was 90.5%. The most frequent diagnostic categories were infectious diseases (13.2%), behavioural and psychiatric disorders (11.6%), neonatal critical care (11.4%), respiratory disorders (8.9%), non-critical neonatology (7.9%), and anaesthesia (6.5%). There were significantly fewer child-only studies (i.e., more mixed child and adult studies) over time (P = 0.0460). The proportion of RCTs to CCTs increased significantly over time (P<0.0001), as did the proportion of multicentre trials (P = 0.002). Significant increases over time were found in methodological quality (Jadad score) (P<0.0001), the proportion of double-blind studies (P<0.0001), and studies with adequate allocation concealment (P<0.0001). Additionally, we found an improvement in reporting over time: adequate description of withdrawals and losses to follow-up (P<0.0001), sample size calculations (P<0.0001), and intention-to-treat analysis (P<0.0001). However, many trials still do not describe their level of blinding, and allocation concealment was inadequately reported in the majority of studies across the entire time period. The proportion of studies with industry funding decreased slightly over time (P = 0.003), and these studies were more likely to report positive conclusions (P = 0.028).Conclusions/significanceThe quantity and quality of pediatric controlled trials has increased over time; however, much work remains to be done, particularly in improving methodological issues around conduct and reporting of trials.

Project description:A growing number of randomized controlled trials (RCTs) have investigated the therapeutic value of yoga interventions. This bibliometric analysis aimed to provide a comprehensive review of the characteristics of the totality of available randomized yoga trials.All RCTs of yoga were eligible. Medline/PubMed, Scopus, the Cochrane Library, IndMED, and the tables of content of yoga specialty journals not listed in medical databases were screened through February 2014. Bibliometric data, data on participants, and intervention were extracted and analyzed descriptively.Published between 1975 and 2014, a total of 366 papers were included, reporting 312 RCTs from 23 different countries with 22,548 participants. The median study sample size was 59 (range 8-410, interquartile range?=?31, 93). Two hundred sixty-four RCTs (84.6%) were conducted with adults, 105 (33.7%) with older adults and 31 (9.9%) with children. Eighty-four RCTs (26.9%) were conducted with healthy participants. Other trials enrolled patients with one of 63 varied medical conditions; the most common being breast cancer (17 RCTs, 5.4%), depression (14 RCTs, 4.5%), asthma (14 RCTs, 4.5%) and type 2 diabetes mellitus (13 RCTs, 4.2%). Whilst 119 RCTs (38.1%) did not define the style of yoga used, 35 RCTs (11.2%) used Hatha yoga and 30 RCTs (9.6%) yoga breathing. The remaining 128 RCTs (41.0%) used 46 varied yoga styles, with a median intervention length of 9 weeks (range 1 day to 1 year; interquartile range?=?5, 12). Two hundred and forty-four RCTs (78.2%) used yoga postures, 232 RCTs (74.4%) used breath control, 153 RCTs (49.0%) used meditation and 32 RCTs (10.3%) used philosophy lectures. One hundred and seventy-four RCTs (55.6%) compared yoga with no specific treatment; 21 varied control interventions were used in the remaining RCTs.This bibliometric analysis presents the most complete up-to-date overview on published randomized yoga trials. While the available research evidence is sparse for most conditions, there was a marked increase in published RCTs in recent years.

Project description:PurposeThis study aimed to investigate the effect of exercise intervention, and analyze exercise intervention strategies for adolescent depression through a meta-analysis of RCTs.MethodsAccordance to PRISMA guidelines, PubMed, Medline, EBSCO, Web of Science, SPORTDiscus, PsycINFO, ProQuest, and CNKI were searched for eligible records. Peer-reviewed studies were included if they met the following criteria: population (mean age of 10-18 years), intervention (physical activity, sport, or exercise), and outcomes (depression, adherence, ITT, dropout, adverse events, follow-up report). The protocol of this systematic review was registered in PROSPERO (CRD42022321683). Effect sizes calculations and methodological quality of exercise intervention (TESTEX scale) were carried out. The certainty of evidence was assessed by GRADE framework.ResultsThirteen randomized controlled trials were eligible for this review, which comprised a total of 433 adolescents. Compared with the control treatment, the effect of exercise on adolescent depression was moderate (SMD = -0.65, 95%CI: -1.03 to -0.27, p < 0.01). Heterogeneity was substantial (T 2 = 0.30, I 2 = 67%, p < 0.01). The moderating effect analysis showed that exercise intervention characteristics (organization form, exercise frequency, exercise intensity, exercise type, and single exercise session duration) of included studies varied greatly revealing multiple factors that may impact the antidepressant effect of exercise on adolescent depression (I 2 > 50%, p < 0.05). Three studies show that the positive effect of exercise on reducing depression in adolescents remained 40 weeks after the intervention. Moreover, owing to the included studies contained methodological limitations, the certainty of evidence was reduced to moderate level.ConclusionThis study shows that exercise intervention has a moderate and sustained positive effect on adolescent depression. Our results recommended that adolescents with depression undertake moderate to high intensity group mixed exercise for more than 12 weeks, 20 to 60 min/time, more than 3 times/week. Additionally, our study also shows that the antidepressant effects remained for a long time after the end of exercise interventions. However, following the GRADE framework, we rated the certainty of evidence the primary meta-analysis as moderate evidence due to some limitations of included studies. Therefore, rigorous studies are still needed to verify the results.Systematic review registration[https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=321683], identifier [CRD42022321683].

Project description:BackgroundNeck pain is a prevalent condition that causes an enormous health care burden due to the lack of efficient therapies. As a promising technology, virtual reality (VR) has shown advantages in orthopedic rehabilitation. However, there is no meta-analysis evaluating the effectiveness of VR in neck pain management.ObjectiveThis study aims to review original randomized controlled trials (RCTs) evaluating the effectiveness of VR for neck pain and to provide evidence for the clinical application of a new alternative approach for pain management.MethodsA total of 9 electronic databases were systematically searched for relevant articles published from inception to October 2022. RCTs in English or Chinese that investigated VR therapy for participants with neck pain were included. The methodological quality and the evidence level were assessed using the Cochrane Back and Neck Risk of Bias tool and the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) guideline, respectively.ResultsA total of 8 studies with 382 participants were included for the final analysis. For the pain intensity, the overall pooled effect size was 0.51, with a standardized mean difference (SMD) of -0.51 (95% CI -0.91 to -0.11; GRADE: moderate), favoring VR therapy compared with controls. Subgroups analyses revealed that significant differences in pain intensity were found in the multimodal intervention (VR in combination with other therapies) than in other interventions (SMD -0.45, 95% CI -0.78 to -0.13; GRADE: moderate), and better analgesic effects were also observed in patients with chronic neck pain receiving VR intervention (SMD -0.70, 95% CI -1.08 to -0.32; GRADE: moderate) and patients treated in the clinic or research unit (SMD -0.52, 95% CI -0.99 to -0.05; GRADE: moderate) than controls. Regarding other health outcomes, the VR experienced less disability, lower kinesiophobia, and greater kinematic function (cervical range of motion, mean and peak velocity). Nevertheless, the follow-up effects of VR therapy on pain intensity and disability were not found.ConclusionsExisting moderate evidence support VR as a beneficial nonpharmacological approach to improve pain intensity in patients with neck pain, with advantages to multimodal intervention, people with chronic neck pain, and clinic or research unit-based VR therapy. However, the limited quantity and high heterogeneity of the articles limit our findings.Trial registrationPROSPERO CRD42020188635; https://tinyurl.com/2839jh8w.

Dataset Information

Randomized controlled trials of malaria intervention trials in Africa, 1948 to 2007: a descriptive analysis.

Background

Methods

Results

Conclusions

Publications

Randomized controlled trials of malaria intervention trials in Africa, 1948 to 2007: a descriptive analysis.

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