Trial reportBMJ (Clinical research ed.)1996
Randomised study of n of 1 trials versus standard practice.
Trial report in BMJ (Clinical research ed.), 1996. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 26 papers, 4 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
26 citing papers in PubMed, 4 syntheses or guidelines pooled it, 102 citations in OpenAlex.
- Outcomes for patients with the same disease treated inside and outside of randomized trials: a systematic review and meta-analysis.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2014Pooled it
- Outcomes of patients who participate in randomized controlled trials compared to similar patients receiving similar interventions who do not participate.The Cochrane database of systematic reviews · 2008Pooled it
- Systematic review to determine whether participation in a trial influences outcome.BMJ (Clinical research ed.) · 2005Pooled it
- N-of-1 trials of quinine efficacy in skeletal muscle cramps of the leg.The British journal of general practice : the journal of the Royal College of General Practitioners · 2005Pooled it
- Two-Arm Crossover Randomized Controlled Trial Versus Meta-Analysis of N-of-1 Studies: Comparison of Statistical Efficiency in Determining an Intervention Effect.Biometrical journal. Biometrische Zeitschrift · 2025Article
- N-of-1 Trials for Pediatric Hypertension? A Promising Approach to Increasing the Precision of Antihypertensive Treatment.American journal of hypertension · 2023Article
- N-of-1 trials to facilitate evidence-based deprescribing: Rationale and case study.British journal of clinical pharmacology · 2022Review
- Conduct and Implementation of Personalized Trials in Research and Practice.Harvard data science review · 2022Article
- A scoping review of randomized trials assessing the impact of n-of-1 trials on clinical outcomes.PloS one · 2022Article
- Individualized therapy trials: navigating patient care, research goals and ethics.Nature medicine · 2021Review
- Single-Subject Research in Psychiatry: Facts and Fictions.Frontiers in psychiatry · 2020Review
- Demonstrating Heterogeneity of Treatment Effects Among Patients: An Overlooked but Important Step Toward Precision Medicine.Clinical pharmacology and therapeutics · 2019Article
- Making the switch: From case studies to N-of-1 trials.Epilepsy & behavior reports · 2019Review
- The history and development of N-of-1 trials.Journal of the Royal Society of Medicine · 2017Article
- N of 1 trials and the optimal individualisation of drug treatments: a systematic review protocol.Systematic reviews · 2017Article
- A new generation of pragmatic trials of psychosocial interventions is needed.Epidemiology and psychiatric sciences · 2013Article
- Overcoming implementation challenges of personalized cancer therapy.Nature reviews. Clinical oncology · 2012Review
- The n-of-1 clinical trial: the ultimate strategy for individualizing medicine?Personalized medicine · 2011Article
- Selecting a change and evaluating its impact on the performance of a complex adaptive health care delivery system.Clinical interventions in aging · 2010Article
- Assessment of progression of COPD: report of a workshop held in Leuven, 11-12 March 2004.Thorax · 2005Review
Corrections and comments
- Commented on by
- Commented on by
- Commented on by
- Erratum issued
Authors and funding
4 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo compare outcomes between groups of patients with irreversible chronic airflow limitation given theophylline by n of 1 trials or standard practice.
designRandomised controlled study of n of 1 trials versus standard practice.
settingTertiary care center outpatient department. SUBJECTS: 31 patients with irreversible chronic airflow limitation who were unsure that theophylline was helpful after an open trial.
interventionsn Of 1 trials (single patient randomised multiple crossover comparisons of theophylline against placebo) followed published guidelines. For standard practice patients theophylline was stopped and resumed if their dyspnoea worsened; if their dyspnoea then improved theophylline was continued. For both groups a decision to continue or stop the drug was made within three months of randomisation.
main outcome measuresExercise capacity as measured by six minute walking distance, quality of life as measured by the chronic respiratory disease questionnaire at baseline and six months after randomisation, and proportions of patients taking theophylline at six months.
results26 patients completed follow up. 47% fewer n of 1 trial patients than standard practice patients were taking theophylline at six months (5/14 versus 10/12; 95% confidence interval of difference 14% to 80%) without differences in exercise capacity or quality of life.
conclusionsn Of 1 trials led to less theophylline use without adverse effects on exercise capacity or quality of life in patients with irreversible chronic airflow limitation. These data directly support the presence of a clinically important bias towards unnecessary treatment during open prescription of theophylline for irreversible chronic airflow limitation. Confirmation in a larger study and similar studies for other problems appropriate for n of 1 trials are needed before widespread use of n of 1 trials can be advocated in routine clinical practice.
Indexed as
Identifiers
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.