An international survey and modified Delphi process revealed editors' perceptions, training needs, and ratings of competency-related statements for the development of core competencies for scientific editors of biomedical journals.

Background: Scientific editors (i.e., those who make decisions on the content and policies of a journal) have a central role in the editorial process at biomedical journals. However, very little is known about the training needs of these editors or what competencies are required to perform effectively in this role. Methods: We conducted a survey of perceptions and training needs among scientific editors from major editorial organizations around the world, followed by a modified Delphi process in which we invited the same scientific editors to rate the importance of competency-related statements obtained from a previous scoping review. Results: A total of 148 participants completed the survey of perceptions and training needs. At least 80% of participants agreed on six of the 38 skill and expertise-related statements presented to them as being important or very important to their role as scientific editors. At least 80% agreed on three of the 38 statements as necessary skills they perceived themselves as possessing (well or very well).  The top five items on participants' list of top training needs were training in statistics, research methods, publication ethics, recruiting and dealing with peer reviewers, and indexing of journals. The three rounds of the Delphi were completed by 83, 83, and 73 participants, respectively, which ultimately produced a list of 23 "highly rated" competency-related statements and another 86 "included" items. Conclusion: Both the survey and the modified Delphi process will be critical for understanding knowledge and training gaps among scientific editors when designing curriculum around core competencies in the future.

Core competencies for scientific editors of biomedical journals: consensus statement.

BACKGROUND: Scientific editors are responsible for deciding which articles to publish in their journals. However, we have not found documentation of their required knowledge, skills, and characteristics, or the existence of any formal core competencies for this role. METHODS: We describe the development of a minimum set of core competencies for scientific editors of biomedical journals. RESULTS: The 14 key core competencies are divided into three major areas, and each competency has a list of associated elements or descriptions of more specific knowledge, skills, and characteristics that contribute to its fulfillment. CONCLUSIONS: We believe that these core competencies are a baseline of the knowledge, skills, and characteristics needed to perform competently the duties of a scientific editor at a biomedical journal.

Assessing the utility of an institutional publications officer: a pilot assessment.

BACKGROUND: The scholarly publication landscape is changing rapidly. We investigated whether the introduction of an institutional publications officer might help facilitate better knowledge of publication topics and related resources, and effectively support researchers to publish. METHODS: In September 2015, a purpose-built survey about researchers' knowledge and perceptions of publication practices was administered at five Ottawa area research institutions. Subsequently, we publicly announced a newly hired publications officer (KDC) who then began conducting outreach at two of the institutions. Specifically, the publications officer gave presentations, held one-to-one consultations, developed electronic newsletter content, and generated and maintained a webpage of resources. In March 2016, we re-surveyed our participants regarding their knowledge and perceptions of publishing. Mean scores to the perception questions, and the percent of correct responses to the knowledge questions, pre and post survey, were computed for each item. The difference between these means or calculated percentages was then examined across the survey measures. RESULTS: 82 participants completed both surveys. Of this group, 29 indicated that they had exposure to the publications officer, while the remaining 53 indicated they did not. Interaction with the publications officer led to improvements in half of the knowledge items (7/14 variables). While improvements in knowledge of publishing were also found among those who reported not to have interacted with the publications officer (9/14), these effects were often smaller in magnitude. Scores for some publication knowledge variables actually decreased between the pre and post survey (3/14). Effects for researchers' perceptions of publishing increased for 5/6 variables in the group that interacted with the publications officer. DISCUSSION: This pilot provides initial indication that, in a short timeframe, introducing an institutional publications officer may improve knowledge and perceptions surrounding publishing. This study is limited by its modest sample size and temporal relationship between the introduction of the publications officer and changes in knowledge and perceptions. A randomized trial examining the publications officer as an effective intervention is needed.

Potential predatory and legitimate biomedical journals: can you tell the difference? A cross-sectional comparison.

BACKGROUND: The Internet has transformed scholarly publishing, most notably, by the introduction of open access publishing. Recently, there has been a rise of online journals characterized as 'predatory', which actively solicit manuscripts and charge publications fees without providing robust peer review and editorial services. We carried out a cross-sectional comparison of characteristics of potential predatory, legitimate open access, and legitimate subscription-based biomedical journals. METHODS: On July 10, 2014, scholarly journals from each of the following groups were identified - potential predatory journals (source: Beall's List), presumed legitimate, fully open access journals (source: PubMed Central), and presumed legitimate subscription-based (including hybrid) journals (source: Abridged Index Medicus). MEDLINE journal inclusion criteria were used to screen and identify biomedical journals from within the potential predatory journals group. One hundred journals from each group were randomly selected. Journal characteristics (e.g., website integrity, look and feel, editors and staff, editorial/peer review process, instructions to authors, publication model, copyright and licensing, journal location, and contact) were collected by one assessor and verified by a second. Summary statistics were calculated. RESULTS: Ninety-three predatory journals, 99 open access, and 100 subscription-based journals were analyzed; exclusions were due to website unavailability. Many more predatory journals' homepages contained spelling errors (61/93, 66%) and distorted or potentially unauthorized images (59/93, 63%) compared to open access journals (6/99, 6% and 5/99, 5%, respectively) and subscription-based journals (3/100, 3% and 1/100, 1%, respectively). Thirty-one (33%) predatory journals promoted a bogus impact metric - the Index Copernicus Value - versus three (3%) open access journals and no subscription-based journals. Nearly three quarters (n = 66, 73%) of predatory journals had editors or editorial board members whose affiliation with the journal was unverified versus two (2%) open access journals and one (1%) subscription-based journal in which this was the case. Predatory journals charge a considerably smaller publication fee (median $100 USD, IQR $63-$150) than open access journals ($1865 USD, IQR $800-$2205) and subscription-based hybrid journals ($3000 USD, IQR $2500-$3000). CONCLUSIONS: We identified 13 evidence-based characteristics by which predatory journals may potentially be distinguished from presumed legitimate journals. These may be useful for authors who are assessing journals for possible submission or for others, such as universities evaluating candidates' publications as part of the hiring process.

Reporting quality and risk of bias in randomised trials in health professions education.

CONTEXT: Complete reporting of research is essential to enable consumers to accurately appraise, interpret and apply findings. Quality appraisal checklists are giving way to tools that judge the risk for bias. OBJECTIVES: We sought to determine the prevalence of these complementary aspects of research reports (completeness of reporting and perceived risk for bias) of randomised studies in health professions education. METHODS: We searched bibliographic databases for randomised studies of health professions education. We appraised two cohorts representing different time periods (2008-2010 and 2014, respectively) and worked in duplicate to apply the CONSORT guidelines and Cochrane Risk of Bias tool. We explored differences between time periods using independent-samples t-tests or the chi-squared test, as appropriate. RESULTS: We systematically identified 180 randomised studies (2008-2010, n = 150; 2014, n = 30). Frequencies of reporting of CONSORT elements within full-text reports were highly variable and most elements were reported in fewer than 50% of studies. We found a statistically significant difference in the CONSORT reporting index (maximum score: 500) between the 2008-2010 (mean ± standard deviation [SD]: 242.7 ± 55.6) and 2014 (mean ± SD: 311.6 ± 53.2) cohorts (p < 0.001). High or unclear risk for bias was most common for allocation concealment (157, 87%) and blinding of participants (147, 82%), personnel (152, 84%) and outcome assessors (112, 62%). Most risk for bias elements were judged to be unclear (range: 51-84%). Risk for bias elements significantly improved over time for blinding of participants (p = 0.007), incomplete data (p < 0.001) and the presence of other sources of bias (p < 0.001). CONCLUSIONS: Reports of randomised studies in health professions education frequently omit elements recommended by the CONSORT statement. Most reports were assessed as having a high or unclear risk for bias. Greater attention to how studies are reported at study outset and in manuscript preparation could improve levels of complete transparent reporting.

Development and validation of the guideline for reporting evidence-based practice educational interventions and teaching (GREET).

BACKGROUND: The majority of reporting guidelines assist researchers to report consistent information concerning study design, however, they contain limited information for describing study interventions. Using a three-stage development process, the Guideline for Reporting Evidence-based practice Educational interventions and Teaching (GREET) checklist and accompanying explanatory paper were developed to provide guidance for the reporting of educational interventions for evidence-based practice (EBP). The aim of this study was to complete the final development for the GREET checklist, incorporating psychometric testing to determine inter-rater reliability and criterion validity. METHODS: The final development for the GREET checklist incorporated the results of a prior systematic review and Delphi survey. Thirty-nine items, including all items from the prior systematic review, were proposed for inclusion in the GREET checklist. These 39 items were considered over a series of consensus discussions to determine the inclusion of items in the GREET checklist. The GREET checklist and explanatory paper were then developed and underwent psychometric testing with tertiary health professional students who evaluated the completeness of the reporting in a published study using the GREET checklist. For each GREET checklist item, consistency (%) of agreement both between participants and the consensus criterion reference measure were calculated. Criterion validity and inter-rater reliability were analysed using intra-class correlation coefficients (ICC). RESULTS: Three consensus discussions were undertaken, with 14 items identified for inclusion in the GREET checklist. Following further expert review by the Delphi panelists, three items were added and minor wording changes were completed, resulting in 17 checklist items. Psychometric testing for the updated GREET checklist was completed by 31 participants (n = 11 undergraduate, n = 20 postgraduate). The consistency of agreement between the participant ratings for completeness of reporting with the consensus criterion ratings ranged from 19 % for item 4 Steps of EBP, to 94 % for item 16 Planned delivery. The overall consistency of agreement, for criterion validity (ICC 0.73) and inter-rater reliability (ICC 0.96), was good to almost perfect. CONCLUSION: The final GREET checklist comprises 17 items which are recommended for reporting EBP educational interventions. Further validation of the GREET checklist with experts in EBP research and education is recommended.

A scoping review of competencies for scientific editors of biomedical journals.

BACKGROUND: Biomedical journals are the main route for disseminating the results of health-related research. Despite this, their editors operate largely without formal training or certification. To our knowledge, no body of literature systematically identifying core competencies for scientific editors of biomedical journals exists. Therefore, we aimed to conduct a scoping review to determine what is known on the competency requirements for scientific editors of biomedical journals. METHODS: We searched the MEDLINE®, Cochrane Library, Embase®, CINAHL, PsycINFO, and ERIC databases (from inception to November 2014) and conducted a grey literature search for research and non-research articles with competency-related statements (i.e. competencies, knowledge, skills, behaviors, and tasks) pertaining to the role of scientific editors of peer-reviewed health-related journals. We also conducted an environmental scan, searched the results of a previous environmental scan, and searched the websites of existing networks, major biomedical journal publishers, and organizations that offer resources for editors. RESULTS: A total of 225 full-text publications were included, 25 of which were research articles. We extracted a total of 1,566 statements possibly related to core competencies for scientific editors of biomedical journals from these publications. We then collated overlapping or duplicate statements which produced a list of 203 unique statements. Finally, we grouped these statements into seven emergent themes: (1) dealing with authors, (2) dealing with peer reviewers, (3) journal publishing, (4) journal promotion, (5) editing, (6) ethics and integrity, and (7) qualities and characteristics of editors. DISCUSSION: To our knowledge, this scoping review is the first attempt to systematically identify possible competencies of editors. Limitations are that (1) we may not have captured all aspects of a biomedical editor's work in our searches, (2) removing redundant and overlapping items may have led to the elimination of some nuances between items, (3) restricting to certain databases, and only French and English publications, may have excluded relevant publications, and (4) some statements may not necessarily be competencies. CONCLUSION: This scoping review is the first step of a program to develop a minimum set of core competencies for scientific editors of biomedical journals which will be followed by a training needs assessment, a Delphi exercise, and a consensus meeting.

Effectiveness and safety of short-stay units in the emergency department: a systematic review.

OBJECTIVES: Overcrowding is a serious and ongoing challenge in Canadian hospital emergency departments (EDs) that has been shown to have negative consequences for patient outcomes. The American College of Emergency Physicians recommends observation/short-stay units as a possible solution to alleviate this problem. However, the most recent systematic review assessing short-stay units shows that there is limited synthesized evidence to support this recommendation; it is over a decade old and has important methodologic limitations. The aim of this study was to conduct a more methodologically rigorous systematic review to update the evidence on the effectiveness and safety of short-stay units, compared with usual care, on hospital and patient outcomes. METHODS: A literature search was conducted using MEDLINE, the Cochrane Library, Embase, ABI/INFOM, and EconLit databases and gray literature sources. Randomized controlled trials of ED short-stay units (stay of 72 hours or less) were compared with usual care (i.e., not provided in a short-stay unit), for adult patients. Risk-of-bias assessments were conducted. Important decision-making (gradable) outcomes were patient outcomes, quality of care, utilization of and access to services, resource use, health system-related outcomes, economic outcomes, and adverse events. RESULTS: Ten reports of five studies were included, all of which compared short-stay units with inpatient care. Studies had small sample sizes and were collectively at a moderate risk of bias. Most outcomes were only reported by one study and the remaining outcomes were reported by two to four studies. No deaths were reported. Three of the four included studies reporting length of stay found a significant reduction among short-stay unit patients, and one of the two studies reporting readmission rates found a significantly lower rate for short-stay unit patients. All four economic evaluations indicated that short-stay units were a cost-saving intervention compared to inpatient care from both hospital and health care system perspectives. Results were mixed for outcomes related to quality of care and patient satisfaction. CONCLUSIONS: Insufficient evidence exists to make conclusions regarding the effectiveness and safety of short-stay units, compared with inpatient care.

A systematic review highlights a knowledge gap regarding the effectiveness of health-related training programs in journalology.

OBJECTIVES: To investigate whether training in writing for scholarly publication, journal editing, or manuscript peer review effectively improves educational outcomes related to the quality of health research reporting. STUDY DESIGN AND SETTING: We searched MEDLINE, Embase, ERIC, PsycINFO, and the Cochrane Library for comparative studies of formalized, a priori-developed training programs in writing for scholarly publication, journal editing, or manuscript peer review. Comparators included the following: (1) before and after administration of a training program, (2) between two or more training programs, or (3) between a training program and any other (or no) intervention(s). Outcomes included any measure of effectiveness of training. RESULTS: Eighteen reports of 17 studies were included. Twelve studies focused on writing for publication, five on peer review, and none fit our criteria for journal editing. CONCLUSION: Included studies were generally small and inconclusive regarding the effects of training of authors, peer reviewers, and editors on educational outcomes related to improving the quality of health research. Studies were also of questionable validity and susceptible to misinterpretation because of their risk of bias. This review highlights the gaps in our knowledge of how to enhance and ensure the scientific quality of research output for authors, peer reviewers, and journal editors.

A Delphi survey to determine how educational interventions for evidence-based practice should be reported: stage 2 of the development of a reporting guideline.

BACKGROUND: Undertaking a Delphi exercise is recommended during the second stage in the development process for a reporting guideline. To continue the development for the Guideline for Reporting Evidence-based practice Educational interventions and Teaching (GREET) a Delphi survey was undertaken to determine the consensus opinion of researchers, journal editors and educators in evidence-based practice (EBP) regarding the information items that should be reported when describing an educational intervention for EBP. METHODS: A four round online Delphi survey was conducted from October 2012 to March 2013. The Delphi panel comprised international researchers, educators and journal editors in EBP. Commencing with an open-ended question, participants were invited to volunteer information considered important when reporting educational interventions for EBP. Over three subsequent rounds participants were invited to rate the importance of each of the Delphi items using an 11 point Likert rating scale (low 0 to 4, moderate 5 to 6, high 7 to 8 and very high >8). Consensus agreement was set a priori as at least 80 per cent participant agreement. Consensus agreement was initially calculated within the four categories of importance (low to very high), prior to these four categories being merged into two (<7 and ≥7). Descriptive statistics for each item were computed including the mean Likert scores, standard deviation (SD), range and median participant scores. Mean absolute deviation from the median (MAD-M) was also calculated as a measure of participant disagreement. RESULTS: Thirty-six experts agreed to participate and 27 (79%) participants completed all four rounds. A total of 76 information items were generated across the four survey rounds. Thirty-nine items (51%) were specific to describing the intervention (as opposed to other elements of study design) and consensus agreement was achieved for two of these items (5%). When the four rating categories were merged into two (<7 and ≥7), 18 intervention items achieved consensus agreement. CONCLUSION: This Delphi survey has identified 39 items for describing an educational intervention for EBP. These Delphi intervention items will provide the groundwork for the subsequent consensus discussion to determine the final inclusion of items in the GREET, the first reporting guideline for educational interventions in EBP.

A systematic review of how studies describe educational interventions for evidence-based practice: stage 1 of the development of a reporting guideline.

BACKGROUND: The aim of this systematic review was to identify which information is included when reporting educational interventions used to facilitate foundational skills and knowledge of evidence-based practice (EBP) training for health professionals. This systematic review comprised the first stage in the three stage development process for a reporting guideline for educational interventions for EBP. METHODS: The review question was 'What information has been reported when describing educational interventions targeting foundational evidence-based practice knowledge and skills?'MEDLINE, Academic Search Premier, ERIC, CINAHL, Scopus, Embase, Informit health, Cochrane Library and Web of Science databases were searched from inception until October - December 2011. Randomised and non-randomised controlled trials reporting original data on educational interventions specific to developing foundational knowledge and skills of evidence-based practice were included.Studies were not appraised for methodological bias, however, reporting frequency and item commonality were compared between a random selection of studies included in the systematic review and a random selection of studies excluded as they were not controlled trials. Twenty-five data items were extracted by two independent reviewers (consistency > 90%). RESULTS: Sixty-one studies met the inclusion criteria (n = 29 randomised, n = 32 non-randomised). The most consistently reported items were the learner's stage of training, professional discipline and the evaluation methods used (100%). The least consistently reported items were the instructor(s) previous teaching experience (n = 8, 13%), and student effort outside face to face contact (n = 1, 2%). CONCLUSION: This systematic review demonstrates inconsistencies in describing educational interventions for EBP in randomised and non-randomised trials. To enable educational interventions to be replicable and comparable, improvements in the reporting for educational interventions for EBP are required. In the absence of a specific reporting guideline, there are a range of items which are reported with variable frequency. Identifying the important items for describing educational interventions for facilitating foundational knowledge and skills in EBP remains to be determined. The findings of this systematic review will be used to inform the next stage in the development of a reporting guideline for educational interventions for EBP.

Effectiveness of brief interventions as part of the Screening, Brief Intervention and Referral to Treatment (SBIRT) model for reducing the nonmedical use of psychoactive substances: a systematic review.

BACKGROUND: The purpose of this systematic review is to assess the effectiveness of brief interventions (BIs) as part of the Screening, Brief Intervention, and Referral to Treatment (SBIRT) model for reducing the nonmedical use of psychoactive substances. METHODS: Bibliographic databases (including MEDLINE, Embase, The Cochrane Library, CINAHL, and PsycINFO to April 2012) and gray literature sources were searched. We included randomized controlled trials that opportunistically screened adolescents or adults and then provided a one-to-one, verbal BI to those at risk of substance-use harm. Of interest was the nonmedical use of psychoactive substances (for example, drugs prohibited by international law), excluding alcohol, nicotine, and caffeine. Interventions comprised four or fewer sessions and were compared with no/delayed intervention or provision of information only. Studies were assessed for bias using the Cochrane risk of bias tool. Results were synthesized narratively. Evidence was interpreted according to the GRADE framework. RESULTS: We identified 8,836 records. Of these, five studies met our inclusion criteria. Two studies compared BI with no BI, and three studies compared BI with information only. Studies varied in characteristics such as substances targeted, screening procedures, and BI administered. Outcomes were mostly reported by a single study, leading to limited or uncertain confidence in effect estimates. CONCLUSIONS: Insufficient evidence exists as to whether BIs, as part of SBIRT, are effective or ineffective for reducing the use of, or harms associated with nonmedical use of, psychoactive substances when these interventions are administered to nontreatment-seeking, screen-detected populations. Updating this review with emerging evidence will be important. TRIAL REGISTRATION: CRD42012002414.

Systematic review of the effectiveness of training programs in writing for scholarly publication, journal editing, and manuscript peer review (protocol).

BACKGROUND: An estimated $100 billion is lost to 'waste' in biomedical research globally, annually, much of which comes from the poor quality of published research. One area of waste involves bias in reporting research, which compromises the usability of published reports. In response, there has been an upsurge in interest and research in the scientific process of writing, editing, peer reviewing, and publishing (that is, journalology) of biomedical research. One reason for bias in reporting and the problem of unusable reports could be due to authors lacking knowledge or engaging in questionable practices while designing, conducting, or reporting their research. Another might be that the peer review process for journal publication has serious flaws, including possibly being ineffective, and having poorly trained and poorly motivated reviewers. Similarly, many journal editors have limited knowledge related to publication ethics. This can ultimately have a negative impact on the healthcare system. There have been repeated calls for better, more numerous training opportunities in writing for publication, peer review, and publishing. However, little research has taken stock of journalology training opportunities or evaluations of their effectiveness. METHODS: We will conduct a systematic review to synthesize studies that evaluate the effectiveness of training programs in journalology. A comprehensive three-phase search approach will be employed to identify evaluations of training opportunities, involving: 1) forward-searching using the Scopus citation database, 2) a search of the MEDLINE In-Process and Non-Indexed Citations, MEDLINE, Embase, ERIC, and PsycINFO databases, as well as the databases of the Cochrane Library, and 3) a grey literature search. DISCUSSION: This project aims to provide evidence to help guide the journalological training of authors, peer reviewers, and editors. While there is ample evidence that many members of these groups are not getting the necessary training needed to excel at their respective journalology-related tasks, little is known about the characteristics of existing training opportunities, including their effectiveness. The proposed systematic review will provide evidence regarding the effectiveness of training, therefore giving potential trainees, course designers, and decision-makers evidence to help inform their choices and policies regarding the merits of specific training opportunities or types of training.

An evaluation of epidemiological and reporting characteristics of complementary and alternative medicine (CAM) systematic reviews (SRs).

BACKGROUND: Systematic reviews (SRs) are abundant. The optimal reporting of SRs is critical to enable clinicians to use their findings to make informed treatment decisions. Complementary and alternative medicine (CAM) therapies are widely used therefore it is critical that conduct and reporting of systematic research in this field be of high quality. Here, methodological and reporting characteristics of a sample of CAM-related SRs and a sample of control SRs are evaluated and compared. METHODS: MEDLINE(®) was searched to identify non-Cochrane SRs indexed from January 2010 to May 2011. Control SRs were retrieved and a search filter was used to identify CAM SRs. Citations were screened and publications that met a pre-specified definition of a SR were included. Pre-designed, standardized data extraction forms were developed to capture reporting and methodological characteristics of the included reviews. Where appropriate, samples were compared descriptively. RESULTS: A total of 349 SRs were identified, of which 174 were CAM-related SRs and 175 were conventional SRs. We compared 131 CAM-related non-Cochrane SRs to the 175 conventional non-Cochrane reviews. Fifty-seven percent (75/131) of CAM SRs specified a primary outcome compared to 21% (37/175) of conventional sample reviews. Reporting of publication bias occurred in less than 5% (6/131) of the CAM sample versus 46% (80/175) of the conventional sample of SRs. Source of funding was frequently and consistently under-reported. Less than 5% (11/306) of all SRs reported public availability of a review protocol. CONCLUSION: The two samples of reviews exhibited different strengths and weaknesses. In some cases there were consistencies across items which indicate the need for continued improvements in reporting for all SR reports. We advise authors to utilise the PRISMA Statement or other SR guidance when reporting SRs.

Protocol for development of the guideline for reporting evidence based practice educational interventions and teaching (GREET) statement.

BACKGROUND: There are an increasing number of studies reporting the efficacy of educational strategies to facilitate the development of knowledge and skills underpinning evidence based practice (EBP). To date there is no standardised guideline for describing the teaching, evaluation, context or content of EBP educational strategies. The heterogeneity in the reporting of EBP educational interventions makes comparisons between studies difficult. The aim of this program of research is to develop the Guideline for Reporting EBP Educational interventions and Teaching (GREET) statement and an accompanying explanation and elaboration (E&E) paper. METHODS/DESIGN: Three stages are planned for the development process. Stage one will comprise a systematic review to identify features commonly reported in descriptions of EBP educational interventions. In stage two, corresponding authors of articles included in the systematic review and the editors of the journals in which these studies were published will be invited to participate in a Delphi process to reach consensus on items to be considered when reporting EBP educational interventions. The final stage of the project will include the development and pilot testing of the GREET statement and E&E paper. OUTCOME: The final outcome will be the creation of a Guideline for Reporting EBP Educational interventions and Teaching (GREET) statement and E&E paper. DISCUSSION: The reporting of health research including EBP educational research interventions, have been criticised for a lack of transparency and completeness. The development of the GREET statement will enable the standardised reporting of EBP educational research. This will provide a guide for researchers, reviewers and publishers for reporting EBP educational interventions.

Effectiveness of quality improvement strategies on the management of diabetes: a systematic review and meta-analysis.

BACKGROUND: The effectiveness of quality improvement (QI) strategies on diabetes care remains unclear. We aimed to assess the effects of QI strategies on glycated haemoglobin (HbA(1c)), vascular risk management, microvascular complication monitoring, and smoking cessation in patients with diabetes. METHODS: We identified studies through Medline, the Cochrane Effective Practice and Organisation of Care database (from inception to July 2010), and references of included randomised clinical trials. We included trials assessing 11 predefined QI strategies or financial incentives targeting health systems, health-care professionals, or patients to improve management of adult outpatients with diabetes. Two reviewers independently abstracted data and appraised risk of bias. FINDINGS: We reviewed 48 cluster randomised controlled trials, including 2538 clusters and 84,865 patients, and 94 patient randomised controlled trials, including 38,664 patients. In random effects meta-analysis, the QI strategies reduced HbA(1c) by a mean difference of 0·37% (95% CI 0·28-0·45; 120 trials), LDL cholesterol by 0·10 mmol/L (0·05-0.14; 47 trials), systolic blood pressure by 3·13 mm Hg (2·19-4·06, 65 trials), and diastolic blood pressure by 1·55 mm Hg (0·95-2·15, 61 trials) versus usual care. We noted larger effects when baseline concentrations were greater than 8·0% for HbA(1c), 2·59 mmol/L for LDL cholesterol, and 80 mm Hg for diastolic and 140 mm Hg for systolic blood pressure. The effectiveness of QI strategies varied depending on baseline HbA(1c) control. QI strategies increased the likelihood that patients received aspirin (11 trials; relative risk [RR] 1·33, 95% CI 1·21-1·45), antihypertensive drugs (ten trials; RR 1·17, 1·01-1·37), and screening for retinopathy (23 trials; RR 1·22, 1·13-1·32), renal function (14 trials; RR 128, 1·13-1·44), and foot abnormalities (22 trials; RR 1·27, 1·16-1·39). However, statin use (ten trials; RR 1·12, 0·99-1·28), hypertension control (18 trials; RR 1·01, 0·96-1·07), and smoking cessation (13 trials; RR 1·13, 0·99-1·29) were not significantly increased. INTERPRETATION: Many trials of QI strategies showed improvements in diabetes care. Interventions targeting the system of chronic disease management along with patient-mediated QI strategies should be an important component of interventions aimed at improving diabetes management. Interventions solely targeting health-care professionals seem to be beneficial only if baseline HbA(1c) control is poor. FUNDING: Ontario Ministry of Health and Long-term Care and the Alberta Heritage Foundation for Medical Research (now Alberta Innovates--Health Solutions).

An evaluation of the completeness of safety reporting in reports of complementary and alternative medicine trials.

BACKGROUND: Adequate reporting of safety in publications of randomized controlled trials (RCTs) is a pre-requisite for accurate and comprehensive profile evaluation of conventional as well as complementary and alternative medicine (CAM) treatments. Clear and concise information on the definition, frequency, and severity of adverse events (AEs) is necessary for assessing the benefit-harm ratio of any intervention. The objectives of this study are to assess the quality of safety reporting in CAM RCTs; to explore the influence of different trial characteristics on the quality of safety reporting. METHODS: Survey of safety reporting in RCTs published in 2009 across 15 widely used CAM interventions identified from the Cochrane Collaboration's CAM Field specialized register of trials. Primary outcome measures, the adequacy of reporting of AEs; was defined and categorized according to the CONSORT for harms extension; the percentage of words devoted to the reporting of safety in the entire report and in the results section. RESULTS: Two-hundred and five trials were included in the review. Of these, 15% (31/205) reported that no harms were observed during the trial period. Of the remaining 174 trials reporting any safety information, only 21% (36/174) had adequate safety reporting.For all trials, the median percentage of words devoted to the reporting of safety in the results section was 2.6. Moreover, 69% (n = 141) of all trials devoted a lesser or equal percentage of words to safety compared to author affiliations. Of the predictor variables used in regression analysis, multicenter trials had more words devoted to safety in the results section than single centre trials (P = 0.045). CONCLUSIONS: An evaluation of safety reporting in the reports of CAM RCTs across 15 different CAM interventions demonstrated that the reporting of harms was largely inadequate. The quality of reporting safety information in primary reports of CAM randomized trials requires improvement.