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In the last 20 years research output has grown exponentially making it really difficult to keep up with the evidence. As a Cochrane citizen scientist you would be helping us to identify and describe the research that may be very important in helping us to determine whether a treatment works, or whether a diagnostic test is accurate.

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Gordon Dooley

RCT identification
Gordon Dooley
Show
Agreement
21 Dec 2015
Fast reduction of peripheral blood endothelial progenitor cells in healthy humans exposed to acute systemic hypoxia.
21 Dec 2015
Flexible trial design in practice - stopping arms for lack-of-benefit and adding research arms mid-trial in STAMPEDE: a multi-arm multi-stage randomized controlled trial.
21 Dec 2015
Survival benefit with erlotinib maintenance therapy in patients with advanced non-small-cell lung cancer (NSCLC) according to response to first-line chemotherapy.
Background: In the placebo-controlled phase III SATURN study, maintenance erlotinib after first-line chemotherapy demonstrated significantly prolonged progression-free survival (PFS) and overall survival (OS) in the overall study population of patients with advanced non-small-cell lung cancer (NSCLC). Methods: After four cycles of platinum-based doublet chemotherapy, patients without progressive disease (PD) were randomised to erlotinib (150 mg/day) or placebo until PD or unacceptable toxicity. In this pre-planned analysis, data are assessed according to response to first-line chemotherapy (complete/partial response [CR/PR] or stable disease [SD]). Results: Following first-line chemotherapy, 889 non-PD patients were included in the intention-to-treat population (55% SD; 44% CR/PR; 1% unknown response). Erlotinib maintenance therapy significantly prolonged PFS in both the SD (hazard ratio [HR] = 0.68; P < 0.0001) and CR/PR (HR = 0.74; P = 0.0059) groups, while OS was significantly prolonged in the SD group only (HR = 0.72; P = 0.0019). The erlotinib-related OS benefit in the SD group remained significant across subgroups, irrespective of tumour histology and/or EGFR mutation status. The incidence of adverse events was similar in the SD group and the overall population, and erlotinib treatment did not negatively impact quality of life. Conclusions: Patients with advanced NSCLC and SD following first-line platinum-based doublet chemotherapy derive a significant OS benefit from maintenance erlotinib therapy. The Author 2011. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.
You said Reject, We said RCT
RCT identification
Gordon Dooley

Summary

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RCT identification
Gordon Dooley
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RCT identification
Gordon Dooley
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RCT identification
Gordon Dooley
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Training records
Gordon Dooley

Welcome to training!

This is where you can learn more about this task.

We’ve put together a brief, interactive training module that will take you through 20 practice records. Each record aims to introduce you to certain aspects of what we are looking for, or what we want you to reject.

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Training records
Gordon Dooley

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Frequently asked questions
Gordon Dooley
Quick reference
Gordon Dooley

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Welcome.

Your mission, should you choose to accept it, is to help us identify reports of randomised controlled trials (RCTs).

If you know what a randomised trial is, you can skip the next stage. If you don't, we'll teach you.

What is a randomised trial and why is it important?

A randomised control trial is a type of research design that randomly assigns participants into an experimental group or a control group. As the study is conducted, the only expected difference between the control and experimental groups in a randomised controlled trial (RCT) is the outcome variable being studied.

It's important because it's our best way of knowing whether a treatment works.

We’re looking for reports of randomised controlled trials (often shortened to RCT) and sometimes also referred to as randomised trials, or controlled trials that may have been randomised or used a quasi-randomisation technique, such as allocating participants to treatment or placebo based on date of birth (which we refer to as CCT). Fancy having a go at it?

An example

The example below is what we call a citation. It's a summary of some research. It's made up of a title and abstract.

Effectiveness of the parent-mediated intervention for children with autism spectrum disorder in south Asia in India and Pakistan (PASS): A randomised controlled trial.

Background: Autism spectrum disorder affects more than 5 million children in south Asia. Although early interventions have been used for the treatment of children in high-income countries, no substantive trials have been done of the interventions adapted for use in low-income and middle-income countries (LMICs). We therefore assessed the feasibility and acceptability of the parent-mediated intervention for autism spectrum disorder in south Asia (PASS) in India and Pakistan. Methods: A single-blind randomised trial of the comparison of 12 sessions of PASS (plus treatment as usual) with treatment as usual alone delivered by non-specialist health workers was done at two centres in Goa, India, and Rawalpindi, Pakistan. Children aged 2-9 years with autism spectrum disorder were randomly assigned (1:1) by use of probabilistic minimisation, controlling for treatment centre (Goa or Rawalpindi), age (<6 years or >6 years), and functional impairment (Vineland Adaptive Behaviour Scale Composite score <65 or >65). The primary outcome was quality of parent-child interaction on the Dyadic Communication Measure for Autism at 8 months. Analysis was by intention to treat. The study is registered with ISRCTN, number ISRCTN79675498. Findings: From Jan 1 to July 30, 2013, 65 children were randomly allocated, 32 to the PASS group (15 in Goa and 17 in Rawalpindi) and 33 to the treatment-as-usual group (15 in Goa and 18 in Rawalpindi). 26 (81%) of 32 participants completed the intervention. After adjustment for minimisation factors and baseline outcome, the primary outcome showed a treatment effect in favour of PASS in parental synchrony (adjusted mean difference 0.25 [95% CI 0.14 to 0.36]; effect size 1.61 [95% CI 0.90 to 2.32]) and initiation of communication by the child with the parent (0.15 [0.04 to 0.26]; effect size 0.99 [0.29 to 1.68]), but time in mutual shared attention was reduced (-0.16 [-0.26 to -0.05]; effect size -0.70 [-1.16 to -0.23]). Interpretation: Our results show the feasibility of adapting and task-shifting an intervention used in a high-income context to LMICs. The findings also replicate the positive primary outcome treatment effects of a parent-mediated communication-focused intervention in the original UK Preschool Autism Communication Trial, with one negative effect not reported previously. Funding: Autism Speaks, USA.

The title typically describes the nature of the research.

The abstract describes the study in a bit more depth, like a summary paragraph.

An example

Your job is to find out whether the title and abstract of a citation is describing a randomised controlled trial in humans.

Effectiveness of the parent-mediated intervention for children with autism spectrum disorder in south Asia in India and Pakistan (PASS): A randomised controlled trial.

Background: Autism spectrum disorder affects more than 5 million children in south Asia. Although early interventions have been used for the treatment of children in high-income countries, no substantive trials have been done of the interventions adapted for use in low-income and middle-income countries (LMICs). We therefore assessed the feasibility and acceptability of the parent-mediated intervention for autism spectrum disorder in south Asia (PASS) in India and Pakistan. Methods: A single-blind randomised trial of the comparison of 12 sessions of PASS (plus treatment as usual) with treatment as usual alone delivered by non-specialist health workers was done at two centres in Goa, India, and Rawalpindi, Pakistan. Children aged 2-9 years with autism spectrum disorder were randomly assigned (1:1) by use of probabilistic minimisation, controlling for treatment centre (Goa or Rawalpindi), age (<6 years or >6 years), and functional impairment (Vineland Adaptive Behaviour Scale Composite score <65 or >65). The primary outcome was quality of parent-child interaction on the Dyadic Communication Measure for Autism at 8 months. Analysis was by intention to treat. The study is registered with ISRCTN, number ISRCTN79675498. Findings: From Jan 1 to July 30, 2013, 65 children were randomly allocated, 32 to the PASS group (15 in Goa and 17 in Rawalpindi) and 33 to the treatment-as-usual group (15 in Goa and 18 in Rawalpindi). 26 (81%) of 32 participants completed the intervention. After adjustment for minimisation factors and baseline outcome, the primary outcome showed a treatment effect in favour of PASS in parental synchrony (adjusted mean difference 0.25 [95% CI 0.14 to 0.36]; effect size 1.61 [95% CI 0.90 to 2.32]) and initiation of communication by the child with the parent (0.15 [0.04 to 0.26]; effect size 0.99 [0.29 to 1.68]), but time in mutual shared attention was reduced (-0.16 [-0.26 to -0.05]; effect size -0.70 [-1.16 to -0.23]). Interpretation: Our results show the feasibility of adapting and task-shifting an intervention used in a high-income context to LMICs. The findings also replicate the positive primary outcome treatment effects of a parent-mediated communication-focused intervention in the original UK Preschool Autism Communication Trial, with one negative effect not reported previously. Funding: Autism Speaks, USA.

The title has a phrase, 'randomised controlled trial' in it.

An example

Your job is to find out whether the title and abstract of a citation is describing a randomised controlled trial in humans.

Effectiveness of the parent-mediated intervention for children with autism spectrum disorder in south Asia in India and Pakistan (PASS): A randomised controlled trial.

Background: Autism spectrum disorder affects more than 5 million children in south Asia. Although early interventions have been used for the treatment of children in high-income countries, no substantive trials have been done of the interventions adapted for use in low-income and middle-income countries (LMICs). We therefore assessed the feasibility and acceptability of the parent-mediated intervention for autism spectrum disorder in south Asia (PASS) in India and Pakistan. Methods: A single-blind randomised trial of the comparison of 12 sessions of PASS (plus treatment as usual) with treatment as usual alone delivered by non-specialist health workers was done at two centres in Goa, India, and Rawalpindi, Pakistan. Children aged 2-9 years with autism spectrum disorder were randomly assigned (1:1) by use of probabilistic minimisation, controlling for treatment centre (Goa or Rawalpindi), age (<6 years or >6 years), and functional impairment (Vineland Adaptive Behaviour Scale Composite score <65 or >65). The primary outcome was quality of parent-child interaction on the Dyadic Communication Measure for Autism at 8 months. Analysis was by intention to treat. The study is registered with ISRCTN, number ISRCTN79675498. Findings: From Jan 1 to July 30, 2013, 65 children were randomly allocated, 32 to the PASS group (15 in Goa and 17 in Rawalpindi) and 33 to the treatment-as-usual group (15 in Goa and 18 in Rawalpindi). 26 (81%) of 32 participants completed the intervention. After adjustment for minimisation factors and baseline outcome, the primary outcome showed a treatment effect in favour of PASS in parental synchrony (adjusted mean difference 0.25 [95% CI 0.14 to 0.36]; effect size 1.61 [95% CI 0.90 to 2.32]) and initiation of communication by the child with the parent (0.15 [0.04 to 0.26]; effect size 0.99 [0.29 to 1.68]), but time in mutual shared attention was reduced (-0.16 [-0.26 to -0.05]; effect size -0.70 [-1.16 to -0.23]). Interpretation: Our results show the feasibility of adapting and task-shifting an intervention used in a high-income context to LMICs. The findings also replicate the positive primary outcome treatment effects of a parent-mediated communication-focused intervention in the original UK Preschool Autism Communication Trial, with one negative effect not reported previously. Funding: Autism Speaks, USA.

The abstract also refers to the trial as it describes children being ‘randomly allocated’ to different treatments.

An example

Your job is to find out whether the title and abstract of a citation is describing a randomised controlled trial in humans.

Effectiveness of the parent-mediated intervention for children with autism spectrum disorder in south Asia in India and Pakistan (PASS): A randomised controlled trial.

Background: Autism spectrum disorder affects more than 5 million children in south Asia. Although early interventions have been used for the treatment of children in high-income countries, no substantive trials have been done of the interventions adapted for use in low-income and middle-income countries (LMICs). We therefore assessed the feasibility and acceptability of the parent-mediated intervention for autism spectrum disorder in south Asia (PASS) in India and Pakistan. Methods: A single-blind randomised trial of the comparison of 12 sessions of PASS (plus treatment as usual) with treatment as usual alone delivered by non-specialist health workers was done at two centres in Goa, India, and Rawalpindi, Pakistan. Children aged 2-9 years with autism spectrum disorder were randomly assigned (1:1) by use of probabilistic minimisation, controlling for treatment centre (Goa or Rawalpindi), age (<6 years or >6 years), and functional impairment (Vineland Adaptive Behaviour Scale Composite score <65 or >65). The primary outcome was quality of parent-child interaction on the Dyadic Communication Measure for Autism at 8 months. Analysis was by intention to treat. The study is registered with ISRCTN, number ISRCTN79675498. Findings: From Jan 1 to July 30, 2013, 65 children were randomly allocated, 32 to the PASS group (15 in Goa and 17 in Rawalpindi) and 33 to the treatment-as-usual group (15 in Goa and 18 in Rawalpindi). 26 (81%) of 32 participants completed the intervention. After adjustment for minimisation factors and baseline outcome, the primary outcome showed a treatment effect in favour of PASS in parental synchrony (adjusted mean difference 0.25 [95% CI 0.14 to 0.36]; effect size 1.61 [95% CI 0.90 to 2.32]) and initiation of communication by the child with the parent (0.15 [0.04 to 0.26]; effect size 0.99 [0.29 to 1.68]), but time in mutual shared attention was reduced (-0.16 [-0.26 to -0.05]; effect size -0.70 [-1.16 to -0.23]). Interpretation: Our results show the feasibility of adapting and task-shifting an intervention used in a high-income context to LMICs. The findings also replicate the positive primary outcome treatment effects of a parent-mediated communication-focused intervention in the original UK Preschool Autism Communication Trial, with one negative effect not reported previously. Funding: Autism Speaks, USA.

If we were classifying this now, we'd click RCT or CCT. Go on, give it a try.

Great, well done!

Just a few more tips about how we're here to help you.

When you're looking at a citation, you'll notice some highlights. Words and phrases highlighted yellow are those which may indicate the citation is describing an RCT or CCT. Citations with highlighted red words are more likely to be Reject records.

So far, you've seen an easy one.

Practice records

Long-term observational study on outpatient treatment of venous diseases with medical compression stockings in Germany The mediven observational study.

Background: As detailed data are lacking on the provision of medical compression stockings (MCSs) in outpatient therapy of venous disorders in Germany, we examined various application parameters of mediven roundknit garments in an 18-month observational study. Results: Findings possibly indicative of impaired tolerability (dry skin [26.5-29.6 %], transient skin irritation [1.3-2.7 %]) were rare and decreased during the course of the study. The number of patients reporting a marked improvement during the past 12 months increased by 41.5-46.1 %, irrespective of the CEAP classification. Up to 84.5 % of participants reported that their well-being remained at a constantly high level, and the CEAP class improved objectively in 17.7 % of participants. The participants were prescribed an average of four prescriptions for MCSs (mainly compression class 2) which, irrespective of the CEAP and BMI, were mostly of a light quality. During the study, 65.3-75.6 % of patients wore the MCSs every day. Conclusion: Our data show that mediven MCSs are very well tolerated and lead to a subjective improvement in symptoms. Nevertheless, our results clearly confirm the need to optimise provision to patients with venous disorders.

Practice records

Compensatory Changes in Calcium Metabolism Accompany the Loss of Vitamin D Receptor (VDR) from the Distal Intestine and Kidney of Mice.

1,25 DihydroxyVitamin D3 (1,25(OH)2 D) increases intestinal Ca absorption when dietary Ca intake is low by inducing gene expression through the Vitamin D receptor (VDR). 1,25(OH)2 D-regulated Ca absorption has been studied extensively in the small intestine, but VDR is also present in the large intestine. Our goal was to determine the impact of large intestinal VDR deletion on Ca and bone metabolism. We used transgenic mice expressing Cre-recombinase driven by the 9.5-kb human caudal type homeobox 2 (CDX2) promoter to delete floxed VDR alleles from the caudal region of the mouse (CDX2-KO). Weanling CDX2-KO mice and control littermates were fed low (0.25%) or normal (0.5%) Ca diets for 7 weeks. Serum and urinary Ca, Vitamin D metabolites, bone parameters, and gene expression were analyzed. Loss of the VDR in CDX2-KO was confirmed in colon and kidney. Unexpectedly, CDX2-KO had lower serum PTH (-65% of controls, p < 0.001) but normal serum 1,25(OH) 2 D and Ca levels. Despite elevated urinary Ca loss (eightfold higher in CDX2-KO) and reduced colonic target genes TRPV6 (-90%) and CaBPD9k (-80%) mRNA levels, CDX2-KO mice had only modestly lower femoral bone density. Interestingly, duodenal TRPV6 and CaBPD9k mRNA expression was fourfold and threefold higher, respectively, and there was a trend toward increased duodenal Ca absorption (+19%, p = 0.076) in the CDX2-KO mice. The major finding of this study is that large intestine VDR significantly contributes to whole-body Ca metabolism but that duodenal compensation may prevent the consequences of VDR deletion from large intestine and kidney in growing mice.

Practice records

Efficacy of advice from healthcare professionals to pregnant women on avoiding constrictive clothing around the trunk: A study protocol for a randomised controlled trial.

Introduction: As a component of midwife care, eliminating clothing that constricts the trunk has been shown to markedly elevate the uterine fundus, soften the uterus and abdomen, and reduce the abdominal wall tension in women admitted to hospital due to the risk of miscarriage or premature delivery. However, no prospective study has conclusively verified the efficacy of avoiding constrictive clothes around the trunk in pregnant women. We aim to verify the efficacy of instructing pregnant women to wear loose clothing that does not constrict the trunk to reduce the risk of premature birth and improve quality of life (QoL) during pregnancy. Methods and analysis: We will conduct a randomised controlled trial of pregnant women scheduled to deliver at the National Center for Child Health and Development in Tokyo, Japan. A total of 616 pregnant women, from whom written informed consent will be obtained, will be allocated randomly to an intervention group or a control group. Women in the control group will be provided with anaemia prevention leaflets at 20 weeks' gestation and skin-care leaflets at 30 weeks' gestation. Women in the intervention group will be provided with the same leaflets and will also receive health advice from health professionals to avoid constrictive clothing around the trunk. The primary outcome will be a difference between these groups in the frequency of any one of the following category variables: (1) cervical length <30 mm up to 28 weeks' gestation, (2) hospital admission for threatened premature delivery, or (3) premature delivery. Secondary outcomes will include QoL during pregnancy, maternal state of health, and status of fetal development. Ethics and dissemination: The Institutional Review Board and Ethics Committee at the National Center for Child Health and Development, Japan, has approved this study. Our findings will be widely disseminated through conference presentations and peer-reviewed publications.

Practice records

Comparison between two different fractionation radiation dose schedules for palliation of advanced solid tumours.

Context: Palliative radiotherapy (RT) is radiation treatment administered with the intent to improve symptoms and relieve suffering. Aims: The aim of this study is to compare between two different fractionation radiation Dose schedules for palliation of advanced solid tumours. Setting and design: An interventional study carried out in the Department of Radiotherapy, RIMS. Materials and Methods: The study population comprised of 60 patients who were histopathologically confirmed patients with dyspnea in lung cancer, bleeding in cervical cancer and pain in rectal cancers. The eligible patients were randomized into two arms, Arm A and Arm B with a 1:1 randomization, consisting of 30 patients in each arm. Patients in Arm A were prescribed tumor dose of 20 Gray (Gy) over 5 fractions (that is 400 cGy per fractions) and the patients in Arm B were prescribed tumor dose of 10 Gy as weekly dose for 2 fraction. Theratron 780-C Cobalt 60 unit (80 cm SSD) was used. Statistical analysis used: statistical packages for the social sciences (SPSS) version 11.5. Result: In both treatment arms, mean symptoms grade of dyspnoea, mean pain scores and mean bleeding grade scores, improved from week 0-12 with better grades in Arm B group which indicated adequate palliation. Conclusion: 10 Gy into 2 fractions once a week (Arm B) gives better symptom palliation than 20 Gy over 5 fractions (Arm A) in advanced solid tumors like lung, rectal and cervix cancers with more toxicities in Arm B.

Practice records

Reduction of self-perceived discomforts in critically ill patients in French intensive care units: Study protocol for a cluster-randomized controlled trial.

Background: It is now well documented that critically ill patients are exposed to stressful conditions and experience discomforts from multiple sources. Improved identification of the discomforts of patients in intensive care units (ICUs) may have implications for managing their care, including consideration of ethical issues, and may assist clinicians in choosing the most appropriate interventions. The primary objective of this study was to assess the effectiveness of a multicomponent program of discomfort reduction in critically ill patients. The secondary objectives were to assess the sustainability of the impact of the program and the potential seasonality effect. Methods/design: We conducted a multicenter, cluster-randomized, controlled, single (patient)-blind study involving 34 French adult ICUs. The experimental intervention was a 6-month period during which the multicomponent program was implemented in the ICU and included the following steps: identification of discomforts, immediate feedback to the healthcare team, and implementation of targeted interventions. The control intervention was a 6-month period during which any program was implemented. The primary endpoint was the monthly overall score of self-reported discomfort from the French questionnaire on discomforts in ICU patients (IPREA). The secondary endpoints were the scores of the discomfort items of IPREA. The sample size was 660 individuals to obtain 80 % power to detect a 25 % difference in the overall discomfort score of IPREA between the two groups (design effect: 2.9). Discussion: The results of this cluster-randomized controlled study are expected to confirm that a multicomponent program of discomfort reduction may be a new strategy in the management of care for critically ill patients. Trial registration: ClinicalTrials.gov NCT02442934, registered 11 May 2015.

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Cochrane Citizen Science

Cochrane exists so that healthcare decisions get better.

We gather and summarise the best evidence from research to help people make informed choices about a treatment or a diagnostic test.

We need your help. In the last 20 years research output has grown exponentially making it really difficult to keep up with the evidence. As a Cochrane citizen scientist you would be helping us to identify and describe the studies that may be very important in helping us determine whether a treatment works, or whether a diagnostic test is accurate.

As a Cochrane citizen scientist you’ll be joining a global community passionate about improving healthcare, and improving the research that informs the decisions we make.

Contributing in this way means that you can

  • Dip in and out of tasks when it suits you
  • You can develop new skills and learn about trial designs as you are doing the tasks
  • You can develop a track record of your contributions which can be used as evidence of your involvement with Cochrane work

People join us from around the world, and for various reasons. Here are some thoughts from current contributors when asked why they joined:

to help myself to be familiar with evidence based medicine, and prepare myself for possible future work with Cochrane”

“to help out with a really important project, but I am also learning at the same time. So it's really great”

“We continually use Cochrane reviews but don't get involved in producing them so this is a way to contribute”

“It feels good to be useful, because Cochrane is a prestigious organisation and also because it helps us stay involved with medical research”

If this sounds like something you’d like to try, then why not give it a go and see what you think [sign-up]

If you have any questions, please don’t hesitate to contact us: CochraneCitizenScience@cochrane.org or anna.noel-storr@rdm.ox.ac.uk

If you want to find out more about Cochrane, you can do that here: www.cochrane.org

 

RCT identification: training

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