Evidence map›Paper›PMID 27354804›Full record

ReviewNeuropsychiatric disease and treatment2016

Randomized controlled trials - a matter of design.

Peter Markus Spieth, Anne Sophie Kubasch, Ana Isabel Penzlin, Ben Min-Woo Illigens, Kristian Barlinn, Timo Siepmann

3 registry-linked trialsAbstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Neuropsychiatric disease and treatment, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 150 papers, 19 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
150citing papers in PubMed, 19 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05336019 nacompletednot on this mapstarted 2022, after this paper: background citation

Effectiveness of the Diabetes Self-management Coaching Program on the Clinical and Behavioral Parameters for Individuals With Type 2 Diabetes in the Ethiopian PC Setting: Mixed-methods Feasibility Randomized Controlled Trial

TypeinterventionalSponsorQueen's UniversityRan2022 to 2023Enrolled40ConditionsType 2 Diabetes, Diabetes Mellitus, Type 2ArmsDiabetes self-management Coaching, Usual care
NCT06732869 narecruitingnot on this mapstarted 2024, after this paper: background citation

PACE - Physical Activity in COPD Using E-Health: Effectiveness of a Personalised eHealth Platform Integrated Into Pulmonary Rehabilitation to Increase Physical Activity in Patients With COPD - a Randomized Controlled Trial

TypeinterventionalSponsorInstituto Politécnico de LeiriaRan2024 to 2025Enrolled57ConditionsCOPD, Physical ActivityArmseHealth physical activity coaching intervention, pulmonary rehabilitation
NCT07745517 nanot yet recruitingnot on this mapstarted 2026, after this paper: background citation

Evaluating the effectiveness of community health nurse-led and text messaging interventions to improve breast cancer screening in ghana: a multi-arm randomised controlled trial

TypeinterventionalSponsorUniversity of HuddersfieldRan2026 to 2027Enrolled828ConditionsBreast Cancer ScreeningArmsCommunity Health Nurse-Led Breast Cancer Screening Education, Text Messaging Breast Cancer Screening Educational Intervention, Control Arm - standard of care
3 · Its place in the literature

Who cites it

150 citing papers in PubMed, 19 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Meta-analysis of the efficacy and safety of vamorolone in Duchenne muscular dystrophy.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2025
    Pooled it
  5. [Extensions of guidelines for reporting types of study in medicine].Revista medica del Instituto Mexicano del Seguro Social · 2022
    Pooled it
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Pooled it
  10. Pooled it
  11. Pooled it
  12. Pooled it
  13. Pooled it
  14. Pooled it
  15. Pooled it
  16. Pooled it
  17. Pooled it
  18. Pooled it
  19. Pooled it
  20. Trial

90 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Peter Markus SpiethDepartment of Anesthesiology and Critical Care Medicine, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Saxony, Germany; Center for Clinical Research and Management Education, Division of Health Care Sciences, Dresden International University, Dresden, Saxony, Germany.
Anne Sophie KubaschPediatric Rheumatology and Immunology, Children's Hospital, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Saxony, Germany.
Ana Isabel PenzlinInstitute of Clinical Pharmacology, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Saxony, Germany.
Ben Min-Woo IlligensCenter for Clinical Research and Management Education, Division of Health Care Sciences, Dresden International University, Dresden, Saxony, Germany; Department of Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
Kristian BarlinnDepartment of Neurology, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Saxony, Germany.
Timo SiepmannCenter for Clinical Research and Management Education, Division of Health Care Sciences, Dresden International University, Dresden, Saxony, Germany; Department of Neurology, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Saxony, Germany; Radcliffe Department of Medicine, John Radcliffe Hospital, University of Oxford, Oxford, Oxfordshire, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Randomized controlled trials (RCTs) are the hallmark of evidence-based medicine and form the basis for translating research data into clinical practice. This review summarizes commonly applied designs and quality indicators of RCTs to provide guidance in interpreting and critically evaluating clinical research data. It further reflects on the principle of equipoise and its practical applicability to clinical science with an emphasis on critical care and neurological research. We performed a review of educational material, review articles, methodological studies, and published clinical trials using the databases MEDLINE, PubMed, and ClinicalTrials.gov. The most relevant recommendations regarding design, conduction, and reporting of RCTs may include the following: 1) clinically relevant end points should be defined a priori, and an unbiased analysis and report of the study results should be warranted, 2) both significant and nonsignificant results should be objectively reported and published, 3) structured study design and performance as indicated in the Consolidated Standards of Reporting Trials statement should be employed as well as registration in a public trial database, 4) potential conflicts of interest and funding sources should be disclaimed in study report or publication, and 5) in the comparison of experimental treatment with standard care, preplanned interim analyses during an ongoing RCT can aid in maintaining clinical equipoise by assessing benefit, harm, or futility, thus allowing decision on continuation or termination of the trial.

Indexed as

CONSORTrandomized clinical trialsRCTstudy designvalidity

Identifiers

PMID27354804
PMCPMC4910682

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.