2 (CONSORT) statement was created as a set of guidelines for use by journal editors, reviewers, and authors to increase the likelihood that RCTs submitted for publication would meet uniform standards for reporting [19]. The Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) were crafted to modify a single item on the 22-item CONSORT list, referring to description of interventions. This item (CONSORT no. 4), calling for “precise details of the interventions for each group and how they were actually administered,” was considered too generic to be of value for improving reporting of acupuncture trials and was expanded to a 6-item list, with each item broken out into subitems, specifying the details of the acupuncture protocol to be reported [18]. Thus, STRICTA was created to complement, not substitute for, CONSORT. It is important to recognize that the CONSORT statement is described as “. . .a tool to improve quality of reporting of RCTs. . . (but not) . . .as a formal quality assessment instrument.” [17, 20]. Despite this disclaimer, over 30 systematic reviews (predominantly focused on biomedical RCTs) have converted the CONSORT guidelines to a variety of scoring systems for evaluating quality of reporting. While several of these adaptations involved only a limited set of “essential” CONSORT items [21–24], many of the reviews devised a scoring system that utilized the full complement of CONSORT items [25–27], with some also breaking out selected items to create larger lists [28–32]. One review, published in Chinese, is the ﬁrst to create a combined CONSORT and STRICTA quantitative assessment tool, applying it to the worldwide literature on RCTs of acupuncture for obesity [33]. A recent review sought to assess and compare the impact of CONSORT and STRICTA on the reporting quality in acupuncture trials during three time periods 1994-1995, 1999-2000, and 2004-2005 [34]. The review concluded that the reporting of selected CONSORT items has improved over time whereas no signiﬁcant improvements were observed in STRICTA items. The authors also state that further exploration of the adherence to CONSORT and STRICTA within acupuncture RCTs is warranted, due to the limited number of studies sampled. The present study describes the independent creation of a combined CONSORT- and STRICTA-based quality of reporting assessment tool, the Oregon CONSORT STRICTA Instrument (OCSI), and its application to acupuncture RCTs, across all conditions, published in the ten-year period following the October, 1997 NIH Consensus Development Conference on Acupuncture [35]. Our aims were to (1) develop a comprehensive quality of reporting assessment instrument based on two existing guidelines for clinical trial reporting, (2) examine mean scores per question, to inform the acupuncture research community as to which research design items are most often poorly reported or omitted, and (3) examine the overall scores per trial, to provide an indication of whether the quality of reporting in acupuncture RCTs has been improving over time. The development and application of OCSI have been presented in preliminary form [36]. Evidence-Based Complementary and Alternative Medicine 2. Methods 2.1. Development of the Oregon CONSORT STRICTA Instru- ment (OCSI). In creating the OCSI quality of reporting assessment tool, we followed the STRICTA recommen- dations of substituting 6 items, relevant to acupuncture and control group interventions, for item no. 4 of the 22 CONSORT items. Each of the resulting 27-item combined CONSORT and STRICTA guidelines was then converted to a question, retaining the CONSORT item sequence and wherever possible preserving the original wording for each item (Table 1). When clariﬁcation was necessary, we modiﬁed sentence structure but strove to remain as close as possible to the original wording. Where more signiﬁcant changes were considered helpful, they were added to a separate list of modiﬁcations for future consideration. A more signiﬁcant problem in converting evaluative guidelines to questions was that most of the CONSORT and STRICTA items contained several embedded subitems that, while related, required modiﬁcation to separate, sub- questions. For example, CONSORT item no. 11, concerned with reporting of blinding, states: “Whether or not participants, those administer- ing the interventions, and those assessing the outcomes were blinded to group assignment. If done, how the success of blinding was evalu- ated.” [17] This compound item was converted to a multipart OCSI question, asking: “Is it stated whether (a) participants, (b) those administering the interventions, and (c) those assessing the outcomes were blinded to group assignment; and (d) was the success of blinding evaluated?” Each of the 27 OCSI questions was constructed to be scored yes = 2, partial = 1, no = 0, or Not Applicable = N/A, based on the composite scoring of its sub-questions. A question was scored partial if its sub-questions received a mix of ratings. If one or more sub-questions were scored N/A, the score for the question was based on the scores of the remaining sub-questions. also could be assigned to an individual question; for example, OCSI question no. 7 regarding reporting of cointerventions was scored if no adjunctive treatment (e.g., herbal medicine or moxibustion) was provided to the acupuncture group. 2.2. Article Selection Criteria. RCTs included for assessment met the following criteria: (1) publication date from Novem- ber 1997 through October 2007; (2) prospective, randomized controlled trial; (3) human subjects; (4) English language; (5) full publication; (6) treatment with ﬁliform acupuncture needles using manual and/or electrostimulation; (7) com- parator/control group consisted of no treatment, a sham procedure, or usual biomedical care. Usual biomedical care was deﬁned a priori as interventions usual and customary to biomedical conditions. These interventions were categorized