Trial reportTrials2014
The challenge of recruiting patients into a placebo-controlled surgical trial.
Trial report in Trials, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01264991 (The Benefit of Arthroscopic Partial Meniscectomy in Middle-Aged Patients - A Double-Blinded Randomized Placebo), which is not on this map. Cited by 16 papers, 3 of them syntheses that pooled 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.
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.
The Benefit of Arthroscopic Partial Meniscectomy in Middle-Aged Patients - A Double-Blinded Randomized Placebo (Sham) Controlled Multi-Centre Trial
Who cites it
16 citing papers in PubMed, 3 syntheses or guidelines pooled it, 40 citations in OpenAlex.
- Pooled it
- Arthroscopic surgery for degenerative knee disease (osteoarthritis including degenerative meniscal tears).The Cochrane database of systematic reviews · 2022Pooled it
- Feasibility of surgical randomised controlled trials with a placebo arm: a systematic review.BMJ open · 2016Pooled it
- Trial
- Psychological factors associated with trial participation among patients eligible for total knee arthroplasty with a non-surgical treatment arm: a comparative cross-sectional study.Acta orthopaedica · 2026Article
- Photobiomodulation in the management of oral mucositis for adult head and neck cancer patients receiving irradiation: the LiTEFORM RCT.Health technology assessment (Winchester, England) · 2022Article
- Emesis in pregnancy - a qualitative study on trial recruitment failure from the EMPOWER internal pilot.Pilot and feasibility studies · 2022Article
- Article
- Patients' attitude towards a sham-controlled trial on pulmonary vein isolation in atrial fibrillation.Clinical research in cardiology : official journal of the German Cardiac Society · 2022Article
- Factors Underlying Patient and Surgeon Willingness to Participate in a Placebo Surgery Controlled trial: A Qualitative Investigation.Annals of surgery open : perspectives of surgical history, education, and clinical approaches · 2021Article
- Placebo comparator group selection and use in surgical trials: the ASPIRE project including expert workshop.Health technology assessment (Winchester, England) · 2021Article
- Article
- Highly impacted bone allograft may allow immediate weight bearing in tibial plateau fractures: A case report.Trauma case reports · 2020Article
- Article
- Pain, placebo, and test of treatment efficacy: a narrative review.British journal of anaesthesia · 2019Review
- Randomised placebo-controlled trials of surgery: ethical analysis and guidelines.Journal of medical ethics · 2016Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundRandomized placebo-controlled trials represent the gold standard in evaluating healthcare interventions but are rarely performed within orthopedics. Ethical concerns or well-known challenges in recruiting patients for surgical trials in general have been expressed and adding a placebo component only adds to this complexity. The purpose of this study was to report the challenges of recruiting patients into an orthopedic placebo-controlled surgical trial, to determine the number of patients needed to be screened and allocated in order to include one participant into the trial, and to identify reasons associated with participation in a placebo-controlled randomized surgical trial.
methodsData were extracted from an ongoing placebo-controlled randomized controlled trial (RCT) on meniscectomy versus placebo surgery. We calculated the number of patients needed to be screened in order to include the required number of participants into the RCT. Participating patients were asked about their rationale for joining the study and which type of information was most useful for deciding upon participation.
resultsA total of 476 patients entered the screening group, of which 190 patients fulfilled the inclusion and exclusion criteria. 102 patients declined to participate in the study due to various reasons and 46 were later excluded (no meniscus lesion on the magnetic resonance imaging scan or withdrawn consent). A total of 40 patients were finally included in the RCT. To include one patient into the RCT, 11.9 individuals needed to be screened. A total of 69% of participating patients considered the oral information to be the most important and the most common reason for participating was the contribution to research (90%).
conclusionsPatients are willing to participate in an orthopedic placebo-controlled surgical trial. Oral information given by the surgeon to the patient and the contribution to research are important aspects to enhance patient recruitment.
trial registrationClinicalTrials.gov NCT01264991, registered 21 December 2010.
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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.