Evidence-Based Complementary and Alternative Medicine Table 2: Distribution of OCSI scores by country. Articles (n) Mean Score (%) Country China USA Germany Sweden UK Norway Italy Taiwan Australia Austria Japan Spain Brazil Croatia Denmark Hong Kong Iran Israel South Korea Canada Switzerland Turkey France Greece Ireland Singapore Thailand Total 3. Results 78 58 45 33 23 14 11 11 10 7 7 4 3 3 3 3 3 3 3 2 2 2 1 1 1 1 1 333 45.2 69.7 73.2 64.4 72.5 68.7 59.6 58.8 72.3 61.6 62.8 85.4 71.2 46.7 63.7 85.0 61.4 59.3 60.9 78.5 75.3 62.7 80.0 48.0 65.0 72.0 62.0 63.0 3.1. Demographics of Included Trials. An initial search of the literature identiﬁed 410 RCTs that appeared to meet the inclusion criteria. Further review of the papers excluded 77 trials for reasons ranging from trials that were duplicate publications to trials that compared two forms of acupunc- ture. Inclusion criteria, including publication date from November 1997 through October 2007, were met by 333 acupuncture RCTs (Appendix B). These trials represented 27 countries with China accounting for the largest share (n = 78; 23.4%). Trials from the top ﬁve countries com- bined, including China, United States, Germany, Sweden, and United Kingdom, totaled 237 (71.2%) (Table 2). Asian countries other than China accounted for 26 (6.9%) trials. No attempt was made to determine how many RCTs were excluded on the basis of non-English language publication. The 333 RCTs appeared in 141 journals, and the large majority of articles were listed in MEDLINE (n = 302; 90.7%). Of the total included trials, almost two-thirds (n = 209; 62.7%) appeared in biomedical journals, with the remainder (n = 124) in journals of complementary and alternative medicine. 5 3.2. OCSI Manual and Interrater Agreement. The initial face validity and consensus-building exercise led to clariﬁcation of OCSI items and drafting of a manual to inform scoring decisions. In most cases, the “Example and Explanation” section of the CONSORT document [17] and the similar section from STRICTA [18] were suﬃcient to facilitate its development. The manual proved especially helpful to set parameters for deciding between a score of partial versus yes, for example, item no. 22(c): “Presentation of P values alone will score partial; for full credit, authors must state precision as a conﬁdence interval (CI).” The OCSI manual is presented as Appendix A. Analysis of the group scoring (ﬁve members of OCSI group) of nine randomly selected articles demonstrates a high reliability (ICC) among raters (r = 0.99) as well as agreement within triads, low (r = 0.77), medium (r = 0.97), and high (r = 0.91) scoring ranges. 3.3. OCSI Scores per Question and per Article. OCSI scores per individual question across all trials are presented in Figure 1. Since a rating of partial is scored as a 1, it is of interest that 7 of the 27 questions showed mean scores <1.0 (ratings between no and partial). Of these seven, only one was of STRICTA origin, question 8, asking for information on practitioner training, experience, and expertise. The other low-scoring questions are those that ask about reporting of sample size calculation (no. 12), randomization generation (no. 13), randomization implementation (no. 14), person responsible for randomization (no. 15), blinding (no. 16), and adverse events (no. 24). Of these poorly reported questions, 4 of 7 demonstrate trends of improvement over time, 3 of which reached statistical signiﬁcance. These are questions: 12 (3.5% improvement P < .052; 95% CI = 0.000–0.071); 13 (4.9% P < .007; 95% CI = 0.014–0.084); 14 (6.2% P < .001; 95% CI = 0.028–0.094); 24 (4.6% P < .016; 95% CI = 0.009–0.083). In contrast, 9 questions showed means ≥1.5 (of a possible 2.0) (Figures 1(a) and 1(b)). The highest scorers among these (in order of ranking) were questions asking for reporting of number and frequency of treatments (no. 6), primary and secondary outcomes (no. 11), scientiﬁc background, and rationale (no. 2), statistical methods (no. 17) and randomization included in title or abstract (no. 1). Distribution of OCSI scores per RCT is presented in Figure 2. The mean percent score for all articles was 63.0 (SD 16.5). The numbers of trials with OCSI scores higher than arbitrary values of 60, 70, and 80% were 197 (59.2%), 133 (39.9%), and 62 (18.6%), respectively. Mean score of RCTs from CAM journals (51.3% SD ± 15.1) was signiﬁcantly lower than the mean from biomedical journals (69.9% ± 13.1) (P < .001; 95% CI = 15.4–21.8%). Of the ﬁve countries publishing the greatest number of RCTs (China, USA, Germany, Sweden, and UK), the mean OCSI score of articles from China (45.2% ± 14%) was signiﬁcantly lower (P < .001; 95% CI = 21.0–28.2%) than mean scores of articles from the other four countries (69.8% ± 2.7). The top ﬁve journals publishing trials that met our inclusion criteria are J Tradit Chin Med (n = 39), Internat J Clin Acupunct (n = 14), Pain (n = 13), J Altern Complement Med (n = 12), and