Ten considerations for open peer review.

Open peer review (OPR), as with other elements of open science and open research, is on the rise. It aims to bring greater transparency and participation to formal and informal peer review processes. But what is meant by `open peer review', and what advantages and disadvantages does it have over standard forms of review? How do authors or reviewers approach OPR? And what pitfalls and opportunities should you look out for? Here, we propose ten considerations for OPR, drawing on discussions with authors, reviewers, editors, publishers and librarians, and provide a pragmatic, hands-on introduction to these issues. We cover basic principles and summarise best practices, indicating how to use OPR to achieve best value and mutual benefits for all stakeholders and the wider research community.

Survey on open peer review: Attitudes and experience amongst editors, authors and reviewers.

Open peer review (OPR) is a cornerstone of the emergent Open Science agenda. Yet to date no large-scale survey of attitudes towards OPR amongst academic editors, authors, reviewers and publishers has been undertaken. This paper presents the findings of an online survey, conducted for the OpenAIRE2020 project during September and October 2016, that sought to bridge this information gap in order to aid the development of appropriate OPR approaches by providing evidence about attitudes towards and levels of experience with OPR. The results of this cross-disciplinary survey, which received 3,062 full responses, show the majority (60.3%) of respondents to be believe that OPR as a general concept should be mainstream scholarly practice (although attitudes to individual traits varied, and open identities peer review was not generally favoured). Respondents were also in favour of other areas of Open Science, like Open Access (88.2%) and Open Data (80.3%). Among respondents we observed high levels of experience with OPR, with three out of four (76.2%) reporting having taken part in an OPR process as author, reviewer or editor. There were also high levels of support for most of the traits of OPR, particularly open interaction, open reports and final-version commenting. Respondents were against opening reviewer identities to authors, however, with more than half believing it would make peer review worse. Overall satisfaction with the peer review system used by scholarly journals seems to strongly vary across disciplines. Taken together, these findings are very encouraging for OPR's prospects for moving mainstream but indicate that due care must be taken to avoid a "one-size fits all" solution and to tailor such systems to differing (especially disciplinary) contexts. OPR is an evolving phenomenon and hence future studies are to be encouraged, especially to further explore differences between disciplines and monitor the evolution of attitudes.

Open Data in Global Environmental Research: The Belmont Forum's Open Data Survey.

This paper presents the findings of the Belmont Forum's survey on Open Data which targeted the global environmental research and data infrastructure community. It highlights users' perceptions of the term "open data", expectations of infrastructure functionalities, and barriers and enablers for the sharing of data. A wide range of good practice examples was pointed out by the respondents which demonstrates a substantial uptake of data sharing through e-infrastructures and a further need for enhancement and consolidation. Among all policy responses, funder policies seem to be the most important motivator. This supports the conclusion that stronger mandates will strengthen the case for data sharing.

Effectiveness of combination therapy with nifedipine GITS: a prospective, 12-week observational study (AdADOSE).

BACKGROUND: Observational studies can provide important information on the efficacy and safety of antihypertensive agents in the real-life clinical setting. AdADOSE was a large observational study to assess the effectiveness of nifedipine GITS in combination with other antihypertensive agent(s). The study was also the first to examine the role of combination therapy with nifedipine GITS in the Middle East, Pakistan and Russia, regions that are associated with particularly high cardiovascular risk. METHODS: AdADOSE was a 12-week, international, multicenter, prospective, observational study. Patients with hypertension (ie, blood pressure [BP] >140/90 mm Hg, or >130/80 mm Hg in patients at high or very high cardiovascular risk) received once-daily nifedipine GITS (30, 60 or 90 mg) in combination with another antihypertensive or as add-on to existing therapy. The primary study endpoint was the proportion of patients who achieved the target BP of <140/90 mm Hg (or <130/80 mm Hg for those at high or very high cardiovascular risk). Study outcomes are reported by descriptive statistics. RESULTS: The study enrolled 4497 patients (n = 4477, safety population; n = 3430, efficacy population). Baseline mean systolic/diastolic BP (SBP/DBP) was 166.4/99.7 mm Hg; 85.2 % of patients had received prior antihypertensive treatment, and 90.6 % had ≥ 1 concomitant diseases. Following combination treatment with nifedipine GITS, target BP was achieved by 64.8% of patients without concomitant diseases, and by 56.5%, 32.3% and 22.6% with 1, 2-3 and >3 concomitant diseases, respectively. The proportion of patients achieving target BP was 51.5% in previously untreated and 33.7% in previously treated patients. Nifedipine GITS combination treatment provided mean SBP/DBP changes of -36.1/-18.8 mm Hg in all patients, -40.2/-21.5 mm Hg in previously untreated patients, and -35.6/-18.4 mm Hg in previously treated patients, with similar BP reductions irrespective of the number of concomitant diseases. Drug-related adverse events (AEs) were reported in 2.6% patients. There were no serious AEs and only 0.8% of patients discontinued due to drug-related AEs. CONCLUSIONS: Combination therapy with nifedipine GITS in a real-life observational setting was highly effective in reducing SBP/DBP in a range of hypertensive patients, with low rates of treatment-related AEs. TRIAL REGISTRATION: at ClinicalTrials.gov registration number NCT01118286 .

Long-acting nifedipine for hypertensive patients in the Middle East and Morocco: observations on efficacy and tolerability of monotherapy or combination therapy.

BACKGROUND: The Middle Eastern and North African region of developing countries is associated with poor rates of blood pressure (BP) control and antihypertensive prescribing patterns. This post hoc analysis of data from an international observational study aimed to investigate the efficacy and tolerability of long-acting nifedipine (30 mg or 60 mg; monotherapy or in combination) in the Middle Eastern and Moroccan populations defined as having high cardiovascular risk. METHODS: This was a prospective, noninterventional, multicenter observational study. Observations from patients (aged ≥ 18 years) with treated or untreated hypertension from the Middle East (Jordan, Saudi Arabia, Kuwait, Lebanon, Qatar, United Arab Emirates, and Yemen) and Morocco are presented. Hypertension grade and cardiovascular risk were defined at baseline, and systolic/diastolic BP change was defined at post-baseline visits (≤3). Adverse events and ratings of therapy efficacy and patient/physician satisfaction were recorded. RESULTS: The study included 1466 patients from the Middle East and 524 from Morocco. Characteristics of the populations differed, with a more severe hypertension profile in Moroccan patients. Despite these differences, nifedipine reduced BP to a similar extent in each group, with efficacy dependent on cardiovascular risk factors such as hypertension grade and age. Few adverse drug reactions occurred and nifedipine was well-tolerated in both populations. Efficacy and satisfaction with therapy were rated highly. CONCLUSION: Good rates of BP control were observed with nifedipine in patients with moderate-to-severe hypertension and high added risk. Published data in these countries suggest poor antihypertensive prescribing patterns and BP control; these data confirm this trend and suggest that suboptimal dosing may be prevalent.

An observational study of acarbose treatment in patients with type 2 diabetes from the Middle East and Morocco.

BACKGROUND: The prevalence of type 2 diabetes is increasing dramatically in the Middle East and North Africa region. However, there are few trials that have determined the effect of antidiabetic treatment in an observational setting in these countries. METHODS: This was a noninterventional study performed in Morocco in 2006-2007 and in the Middle East in 2005-2006 to observe the efficacy and safety of acarbose in patients with pretreated or untreated type 2 diabetes. Glycemic parameters (fasting blood glucose, one-hour postprandial blood glucose, and HbA1c) were recorded within a 3-month period. The observation period included an initial visit at the start of acarbose therapy and up to three follow-ups. RESULTS: Acarbose was effective in reducing glycemic parameters in patients from Morocco (n = 1082) and the Middle East (n = 1737). The mean one-hour postprandial blood glucose decreased by 35.5% to 165.4 ± 47.9 mg/dL in the Middle East and by 35.5% to 179.0 ± 49.9 mg/dL in Morocco. Mean fasting blood glucose decreased by 30.8% to 126.6 ± 34.2 mg/dL (Middle East) and by 34.5% to 150.6 ± 47.1 mg/dL (Morocco). The absolute reduction in HbA1c was 1.3% in the Middle East (final value 7.4%) and 1.0% in Morocco (final value 7.5%). Overall, 107 patients (Middle East) and 26 patients (Morocco) experienced minor drug-related adverse events, which were mainly gastrointestinal. The tolerability of acarbose was rated as very good/good by 80.8% in the Middle East and by 68.6% in Morocco. CONCLUSION: This study illustrates the efficacy and safety of acarbose in the treatment of type 2 diabetic patients in an observational setting.

A multinational, observational study to investigate the efficacy, safety and tolerability of acarbose as add-on or monotherapy in a range of patients: the Gluco VIP study.

BACKGROUND AND OBJECTIVES: The burden of type 2 diabetes mellitus is growing rapidly, particularly in the Asia-Pacific region. The aim of this international, large-scale, observational study was to investigate the efficacy and tolerability of the antidiabetic agent acarbose as add-on or monotherapy in a range of patients with type 2 diabetes, including those with cardiovascular morbidities. The majority of practices were included from high-burden regions (predominantly those in the Asia-Pacific region). METHODS: This was an observational study conducted in 15 countries/regions. Adults with pre-treated or untreated type 2 diabetes prescribed acarbose as add-on or monotherapy were eligible. Two-hour postprandial blood glucose (2-h PPG), glycosylated haemoglobin (HbA1c) and fasting blood glucose (FBG) were measured over a 3-month observation period. RESULTS: A total of 15,034 patients were valid for the efficacy analysis and 15,661 for the safety analysis (mean age was 57.6 years and 92.6 % of patients were Asian). Mean (SD) 2-h PPG decreased by -71.9 (62.3) mg/dL, to 170.2 (46.5) mg/dL at final visit (after 12.8 [4.1] weeks). Mean HbA1c decreased by -1.1 % (1.3) to 7.2 % (1.1) and mean FBG decreased by -33.0 (43.3) mg/dL to 124.8 (30.5) mg/dL. Acarbose was effective regardless of the presence of cardiovascular co-morbidities or diabetic complications. The efficacy of acarbose was rated 'very good' or 'good' in 85.5 % of patients, and tolerability as 'very good' or 'good' in 84.9 % of patients. Drug-related adverse events, mainly gastrointestinal, were reported in 490/15,661 patients (3.13 %). CONCLUSION: The results of this observational study support the notion that acarbose is effective, safe and well tolerated in a large cohort of Asian patients with type 2 diabetes.

International noninterventional study of acarbose treatment in patients with type 2 diabetes mellitus.

AIM: To obtain data on efficacy, safety and tolerability of acarbose monotherapy or combination therapy during daily-life treatment. METHODS: This prospective, non-controlled, observational study enrolled patients with type 2 diabetes, whose physician decided that acarbose treatment was appropriate, from China, Middle East, Indonesia, Morocco, Pakistan, Philippines, Poland and Taiwan. The observation period included an initial visit and up to three follow-up visits; an extension of 2 years was realized in Pakistan and Poland. RESULTS: Of 14,574 patients enrolled, 14,418 comprised the intent-to-treat population. At the initial visit, 74.1% of patients had been treated with a glucose-lowering agent. Fasting blood glucose was reduced from 175.2mg/dL at the initial visit to 133.7 mg/dL at the last visit (mean of 11.3 weeks after initial visit; P<0.0001). Mean 2-h postprandial blood glucose decreased from 244.7 mg/dL to 172.4 mg/dL (P<0.0001). HbA1c reduced from 8.4% to 7.4% (P<0.0001). Glycemic efficacy was maintained over the 2-year extension period. There were 432 adverse events in 293 patients (2.03%), mainly gastrointestinal. Physicians assessed efficacy as "very good"/"good" in 85.1% of patients, and were "very satisfied"/"satisfied" with acarbose therapy in 94.3% of cases. CONCLUSION: Acarbose therapy was efficacious and well tolerated in daily life in patients with type 2 diabetes.