Objective:To evaluate the quality of reporting of single-patient (N-of-1) trials published in the medical literature based on the CONSORT Extension for N-of-1 Trials (CENT) statement and to examine factors that influence reporting quality in these trials.Methods: Through a search of 10 electronic databases, we identified N-of-1 trials in clinical medicine published between 1 January 1985 and 31 December 2013. Two reviewers screened articles for eligibility and independently extracted data. Quality assessment was performed using the CENT statement. Discrepancies were resolved by consensus.
Results:We identified 112 eligible N-of-1 trials published in 87 journals and involving a total of 2278 patients. Overall agreement between the two evaluators for compliance with CENT criteria was 0.80 (95% CI, 0.79 to 0.82). Trials assessed pharmacology and therapeutics (87%), behavior (11%), or diagnosis (2%). Although 87% of articles described the trial design (including the planned number of subjects and length of treatment period), the median percentage of specific CENT elements in the Methods was 41% (range 16% to 87%) and the median percentage in the Results was 38% (range 32% to 93%). First authors were predominantly from North America (46%), Europe (29%), and Australia (17%). Quality of reporting was higher in papers published in journals with relatively high impact factors (P=0.004).
Conclusion:The quality of reporting of published N-of-1 trials is variable and needs improvement. Because the CENT guidelines were not published until near the end of the period of this review, these results represent a baseline from which improvement may be expected in the future.
This systematic review found encouraging albeit limited evidence for SFI combined with chemotherapy. However, to obtain stronger evidence without the drawbacks of trial design and the quality of studies, we recommend comparative effectiveness researches to test the effectiveness of combination treatment.
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