ArticleBMJ (Clinical research ed.)2008
Improving the reporting of pragmatic trials: an extension of the CONSORT statement.
Article in BMJ (Clinical research ed.), 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 9 registered trials, which are not on this map. Cited by 813 papers, 15 of them syntheses that pooled it.
What it found
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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.
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.
A Prospective, Randomized, Parallel-group, Adaptive Design Phase IIb/III, Multicenter Study, to Assess the Efficacy of Polychemotherapy for Inducing Remission of Newly Diagnosed Type 2 Diabetes.
Effectiveness of a Short, Intensive and Standardised Spa Therapy for Subacute and Chronic Low Back Pain on Return to Work for Patients in Sick Leave From 4 to 24 Weeks Duration : a Randomized Controlled Trial Using a Modified Zelen Method
Mindfulness as a Complementary Intervention for Overweight Primary Care Patients: Study Protocol for a Randomized Controlled Trial
CareWell - Multi-level Integration for Patients With Complex Needs
Does the Technique of Duodenal Resection Affect the Incidence of Duodenal Stump Fistula After Gastrectomy for Gastric Cancer ? A Randomized Controlled Trial (DRTST: Duodenal Resection Tri-staple Technology)
Is arthroplaSty bEtter Than interNal Fixation in the undiSplaced Femoral nEck Fracture? A National Pragmatical Randomized Controlled Trial - the SENSE Trial
A Practice-Based Intervention To Improve Care for a Diverse Population Of Women With Urinary Incontinence
Effect of Accelerated Postoperative Rehabilitation After Tibial Tubercle Distalisation: a Randomised Controlled Trial Protocol
Acupuncture for Long COVID Neuropsychiatric Symptoms: a Pragmatic,Randomized Clinical Trial
Who cites it
813 citing papers in PubMed, 15 syntheses or guidelines pooled it.
- A Systematic Review and Meta-Analysis of the Effectiveness of Process Interventions for Reducing Distress During Vaccine Injections.The Clinical journal of pain · 2026Pooled it
- Endovascular versus open surgery repair of intact abdominal aortic aneurysm: systematic review of randomized controlled trials and critical appraisal of meta-analyses.Systematic reviews · 2026Pooled it
- The impact of acting training on emotion recognition and expression: a systematic review.Frontiers in psychology · 2026Pooled it
- Interventions for preventing falls in older people in care facilities.The Cochrane database of systematic reviews · 2025Pooled it
- CONSORT 2025 statement: updated guideline for reporting randomized trials: a Korean translation.Ewha medical journal · 2025Guideline
- Does WASH FIT Improve Water, Sanitation, and Hygiene and Related Health Impacts in Healthcare Facilities? A Systematic Review.International journal of environmental research and public health · 2025Pooled it
- Metronomic chemotherapy for paediatric extracranial solid tumours: a systematic review and meta-analysis of randomised clinical trials.BMJ open · 2024Pooled it
- PRECIS-2 analysis of pragmatic acupuncture trials: a systematic review.BMC complementary medicine and therapies · 2024Pooled it
- Randomized controlled trials comparing gastric bypass, gastric band, and sleeve gastrectomy: A systematic review examining validity and applicability to wider clinical practice.Obesity reviews : an official journal of the International Association for the Study of Obesity · 2024Pooled it
- Use of pragmatic randomized trials in multiple sclerosis: A systematic overview.Multiple sclerosis (Houndmills, Basingstoke, England) · 2024Pooled it
- A Systematic Review of Outcomes Related to Nurse Practitioner-Delivered Primary Care for Multiple Chronic Conditions.Medical care research and review : MCRR · 2023Pooled it
- Video Recording Patients for Direct Care Purposes: Systematic Review and Narrative Synthesis of International Empirical Studies and UK Professional Guidance.Journal of medical Internet research · 2023Pooled it
- Pooled it
- [Extensions of guidelines for reporting types of study in medicine].Revista medica del Instituto Mexicano del Seguro Social · 2022Pooled it
- Screening for depression among the general adult population and in women during pregnancy or the first-year postpartum: two systematic reviews to inform a guideline of the Canadian Task Force on Preventive Health Care.Systematic reviews · 2022Guideline
- Effectiveness of hypnotherapy for paediatric abdominal pain in primary care: a randomised controlled trial.The British journal of general practice : the journal of the Royal College of General Practitioners · 2026Trial
- Trial
- Population-level effects on crime of recovering firearms from armed prohibited persons: intention-to-treat analysis of a pragmatic cluster-randomised trial in California cities.Injury prevention : journal of the International Society for Child and Adolescent Injury Prevention · 2026Trial
- One-year concurrent training improves physical performance and handgrip strength in nursing home residents.GeroScience · 2026Trial
- A multimodal prehabilitation class for Enhanced Recovery After Surgery: a pragmatic randomised type 1 hybrid effectiveness-implementation trial.British journal of anaesthesia · 2026Trial
753 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
Abstract
backgroundThe CONSORT statement is intended to improve reporting of randomised controlled trials and focuses on minimising the risk of bias (internal validity). The applicability of a trial's results (generalisability or external validity) is also important, particularly for pragmatic trials. A pragmatic trial (a term first used in 1967 by Schwartz and Lellouch) can be broadly defined as a randomised controlled trial whose purpose is to inform decisions about practice. This extension of the CONSORT statement is intended to improve the reporting of such trials and focuses on applicability. Methods At two, two-day meetings held in Toronto in 2005 and 2008, we reviewed the CONSORT statement and its extensions, the literature on pragmatic trials and applicability, and our experiences in conducting pragmatic trials. Recommendations We recommend extending eight CONSORT checklist items for reporting of pragmatic trials: the background, participants, interventions, outcomes, sample size, blinding, participant flow, and generalisability of the findings. These extensions are presented, along with illustrative examples of reporting, and an explanation of each extension. Adherence to these reporting criteria will make it easier for decision makers to judge how applicable the results of randomised controlled trials are to their own conditions. Empirical studies are needed to ascertain the usefulness and comprehensiveness of these CONSORT checklist item extensions. In the meantime we recommend that those who support, conduct, and report pragmatic trials should use this extension of the CONSORT statement to facilitate the use of trial results in decisions about health care.
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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.