ArticleBMJ open2019
Protocol for a feasibility study of a cohort embedded randomised controlled trial comparing
Article in BMJ open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
10 citing papers in PubMed, 21 citations in OpenAlex.
- PROState Pathway Embedded Comparative Trial: The IP3-PROSPECT study.Contemporary clinical trials · 2021Trial
- Nephron Sparing Treatment (NEST) for small renal masses: understanding patients' and clinicians' experiences of a cohort-embedded randomised control trial.Pilot and feasibility studies · 2026Article
- Image-Guided Ablation of Renal Masses: Challenges to Produce High-Quality Evidence and Future Directions.Seminars in interventional radiology · 2024Review
- Ablative Treatments for Small Renal Masses and Management of Recurrences: A Comprehensive Review.Life (Basel, Switzerland) · 2024Review
- Randomised trials conducted using cohorts: a scoping review.BMJ open · 2024Article
- Imaging considerations for thermal and radiotherapy ablation of primary and metastatic renal cell carcinoma.Abdominal radiology (New York) · 2021Review
- Renal cryoablation - a practical guide for interventional radiologists.The British journal of radiology · 2021Review
- Current evidence on screening for renal cancer.Nature reviews. Urology · 2020Review
- Partial nephrectomy versus thermal ablation for clinical T1 renal tumours.Annals of translational medicine · 2019Article
- Cohort multiple randomized controlled trial in pediatric asthma to assess the long- and short-term effects of eHealth interventions: protocol of the CIRCUS study.Therapeutic advances in respiratory diseaseArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors at 4 institutions in 1 country.
Funding
Abstract
introductionSmall renal masses (SRMs; ≤4 cm) account for two-thirds of new diagnoses of kidney cancer, the majority of which are incidental findings. The natural history of the SRM seems largely indolent. There is an increasing concern regarding surgical overtreatment and the associated health burden in terms of morbidity and economy. Observational data support the safety and efficacy of percutaneous cryoablation but there is an unmet need for high-quality evidence on non-surgical management options and a head-to-head comparison with standard of care is lacking. Historical interventional trial recruitment difficulties demand novel study conduct approaches. We aim to assess if a novel trial design, the cohort embedded randomised controlled trial (RCT), will enable carrying out such a comparison. METHODS AND ANALYSIS: Single-centre prospective cohort study of adults diagnosed with SRM (n=200) with an open label embedded interventional RCT comparing nephron sparing interventions. Cohort participants will be managed at patient and clinicians' discretion and agree with longitudinal clinical data and biological sample collection, with invitation for trial interventions and participation in comparator control groups. Cohort participants with biopsy-proven renal cell carcinoma eligible for both percutaneous cryoablation and partial nephrectomy will be randomly selected (1:1) and invited to consider percutaneous cryoablation (n=25). The comparator group will be robotic partial nephrectomy (n=25). The primary outcome of this feasibility study is participant recruitment. Qualitative research techniques will assess barriers and recruitment improvement opportunities. Secondary outcomes are participant trial retention, health-related quality of life, treatment complications, blood transfusion rate, intensive care unit admission and renal replacement requirement rates, length of hospital stay, time to return to pre-treatment activities, number of work days lost, and health technologies costs. ETHICS AND DISSEMINATION: Ethical approval has been granted (UK HRA REC 19/EM/0004). Study outputs will be presented and published.
trial registrationISRCTN18156881; Pre-results.
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What OpenQuestion holds
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.