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1.  Fate of Clinical Research Studies after Ethical Approval – Follow-Up of Study Protocols until Publication 
PLoS ONE  2014;9(2):e87184.
Background
Many clinical studies are ultimately not fully published in peer-reviewed journals. Underreporting of clinical research is wasteful and can result in biased estimates of treatment effect or harm, leading to recommendations that are inappropriate or even dangerous.
Methods
We assembled a cohort of clinical studies approved 2000–2002 by the Research Ethics Committee of the University of Freiburg, Germany. Published full articles were searched in electronic databases and investigators contacted. Data on study characteristics were extracted from protocols and corresponding publications. We characterized the cohort, quantified its publication outcome and compared protocols and publications for selected aspects.
Results
Of 917 approved studies, 807 were started and 110 were not, either locally or as a whole. Of the started studies, 576 (71%) were completed according to protocol, 128 (16%) discontinued and 42 (5%) are still ongoing; for 61 (8%) there was no information about their course. We identified 782 full publications corresponding to 419 of the 807 initiated studies; the publication proportion was 52% (95% CI: 0.48–0.55). Study design was not significantly associated with subsequent publication. Multicentre status, international collaboration, large sample size and commercial or non-commercial funding were positively associated with subsequent publication. Commercial funding was mentioned in 203 (48%) protocols and in 205 (49%) of the publications. In most published studies (339; 81%) this information corresponded between protocol and publication. Most studies were published in English (367; 88%); some in German (25; 6%) or both languages (27; 6%). The local investigators were listed as (co-)authors in the publications corresponding to 259 (62%) studies.
Conclusion
Half of the clinical research conducted at a large German university medical centre remains unpublished; future research is built on an incomplete database. Research resources are likely wasted as neither health care professionals nor patients nor policy makers can use the results when making decisions.
doi:10.1371/journal.pone.0087184
PMCID: PMC3929354  PMID: 24586265
2.  How Psychiatry Journals Support the Unbiased Translation of Clinical Research. A Cross-Sectional Study of Editorial Policies 
PLoS ONE  2013;8(10):e75995.
Introduction
Reporting guidelines (e.g. CONSORT) have been developed as tools to improve quality and reduce bias in reporting research findings. Trial registration has been recommended for countering selective publication. The International Committee of Medical Journal Editors (ICMJE) encourages the implementation of reporting guidelines and trial registration as uniform requirements (URM). For the last two decades, however, biased reporting and insufficient registration of clinical trials has been identified in several literature reviews and other investigations. No study has so far investigated the extent to which author instructions in psychiatry journals encourage following reporting guidelines and trial registration.
Method
Psychiatry Journals were identified from the 2011 Journal Citation Report. Information given in the author instructions and during the submission procedure of all journals was assessed on whether major reporting guidelines, trial registration and the ICMJE’s URM in general were mentioned and adherence recommended.
Results
We included 123 psychiatry journals (English and German language) in our analysis. A minority recommend or require 1) following the URM (21%), 2) adherence to reporting guidelines such as CONSORT, PRISMA, STROBE (23%, 7%, 4%), or 3) registration of clinical trials (34%). The subsample of the top-10 psychiatry journals (ranked by impact factor) provided much better but still improvable rates. For example, 70% of the top-10 psychiatry journals do not ask for the specific trial registration number.
Discussion
Under the assumption that better reported and better registered clinical research that does not lack substantial information will improve the understanding, credibility, and unbiased translation of clinical research findings, several stakeholders including readers (physicians, patients), authors, reviewers, and editors might benefit from improved author instructions in psychiatry journals. A first step of improvement would consist in requiring adherence to the broadly accepted reporting guidelines and to trial registration.
doi:10.1371/journal.pone.0075995
PMCID: PMC3797836  PMID: 24146806
3.  Detecting, quantifying and adjusting for publication bias in meta-analyses: protocol of a systematic review on methods 
Systematic Reviews  2013;2:60.
Background
Health professionals and policymakers aspire to make healthcare decisions based on the entire relevant research evidence. This, however, can rarely be achieved because a considerable amount of research findings are not published, especially in case of ‘negative’ results - a phenomenon widely recognized as publication bias. Different methods of detecting, quantifying and adjusting for publication bias in meta-analyses have been described in the literature, such as graphical approaches and formal statistical tests to detect publication bias, and statistical approaches to modify effect sizes to adjust a pooled estimate when the presence of publication bias is suspected. An up-to-date systematic review of the existing methods is lacking.
Methods/design
The objectives of this systematic review are as follows:
• To systematically review methodological articles which focus on non-publication of studies and to describe methods of detecting and/or quantifying and/or adjusting for publication bias in meta-analyses.
• To appraise strengths and weaknesses of methods, the resources they require, and the conditions under which the method could be used, based on findings of included studies.
We will systematically search Web of Science, Medline, and the Cochrane Library for methodological articles that describe at least one method of detecting and/or quantifying and/or adjusting for publication bias in meta-analyses. A dedicated data extraction form is developed and pilot-tested. Working in teams of two, we will independently extract relevant information from each eligible article. As this will be a qualitative systematic review, data reporting will involve a descriptive summary.
Discussion
Results are expected to be publicly available in mid 2013. This systematic review together with the results of other systematic reviews of the OPEN project (To Overcome Failure to Publish Negative Findings) will serve as a basis for the development of future policies and guidelines regarding the assessment and handling of publication bias in meta-analyses.
doi:10.1186/2046-4053-2-60
PMCID: PMC3733739  PMID: 23885765
Publication bias; Full publication; Underreporting; Detecting; Quantifying; The OPEN project
4.  Publication bias in animal research: a systematic review protocol 
Systematic Reviews  2013;2:23.
Background
Systematic reviews and meta-analyses of pre-clinical studies, in vivo animal experiments in particular, can influence clinical care. Publication bias is one of the major threats of validity in systematic reviews and meta-analyses. Previous empirical studies suggested that systematic reviews and meta-analyses have become more prevalent until 2010 and found evidence for compromised methodological rigor with a trend towards improvement. We aim to comprehensively summarize and update the evidence base on systematic reviews and meta-analyses of animal studies, their methodological quality and assessment of publication bias in particular.
Methods/Design
The objectives of this systematic review are as follows:
•To investigate the epidemiology of published systematic reviews of animal studies until present.
•To examine methodological features of systematic reviews and meta-analyses of animal studies with special attention to the assessment of publication bias.
•To investigate the influence of systematic reviews of animal studies on clinical research by examining citations of the systematic reviews by clinical studies.
Eligible studies for this systematic review constitute systematic reviews and meta-analyses that summarize in vivo animal experiments with the purpose of reviewing animal evidence to inform human health. We will exclude genome-wide association studies and animal experiments with the main purpose to learn more about fundamental biology, physical functioning or behavior.
In addition to the inclusion of systematic reviews and meta-analyses identified by other empirical studies, we will systematically search Ovid Medline, Embase, ToxNet, and ScienceDirect from 2009 to January 2013 for further eligible studies without language restrictions.
Two reviewers working independently will assess titles, abstracts, and full texts for eligibility and extract relevant data from included studies. Data reporting will involve a descriptive summary of meta-analyses and systematic reviews.
Discussion
Results are expected to be publicly available later in 2013 and may form the basis for recommendations to improve the quality of systematic reviews and meta-analyses of animal studies and their use with respect to clinical care.
doi:10.1186/2046-4053-2-23
PMCID: PMC3651300  PMID: 23621910
Publication bias; Animal experimentation; Systematic review; meta-analysis; The OPEN Project
5.  Correction: Scientific Value of Systematic Reviews: Survey of Editors of Core Clinical Journals 
PLoS ONE  2012;7(10):10.1371/annotation/b9a9cb87-3d96-47e4-a073-a7e97a19f47c.
doi:10.1371/annotation/b9a9cb87-3d96-47e4-a073-a7e97a19f47c
PMCID: PMC3476878
6.  Tamoxifen for the management of breast events induced by non-steroidal antiandrogens in patients with prostate cancer: a systematic review 
BMC Medicine  2012;10:96.
Background
Tamoxifen has emerged as a potential management option for gynecomastia and breast pain due to non-steroidal antiandrogens, and it is considered an alternative to surgery or radiotherapy. The objective of this systematic review was to assess the benefits and harms of tamoxifen, in comparison to other treatment options, for either the prophylaxis or treatment of breast events induced by non-steroidal antiandrogens in prostate cancer patients.
Methods
We searched CENTRAL, MEDLINE, EMBASE, reference lists, the abstracts of three major conferences and three trial registers to identify ongoing randomized controlled trials (RCTs). Two authors independently screened the articles identified, assessed the trial quality and extracted data. The protocol was prospectively registered (CRD42011001320; http://www.crd.york.ac.uk/PROSPERO).
Results
Four studies were identified. Tamoxifen significantly reduced the risk of suffering from gynecomastia (risk ratio 9RR0 0.10, 95% CI 0.05 to 0.22) or breast pain (RR 0.06, 95% CI 0.02 to 0.17) at six months compared to untreated controls. Tamoxifen also showed a significant benefit for the prevention of gynecomastia (RR 0.22, 95% CI 0.08 to 0.58) and breast pain (RR 0.25, 95% CI 0.10 to 0.64) when compared to anastrozole after a median of 12 months. One study showed a significant benefit of tamoxifen for the prevention of gynecomastia (RR 0.24, 95% CI 0.09 to 0.65) and breast pain (RR 0.20, 95% CI 0.06 to 0.65) when compared with radiotherapy at six months. Radiotherapy increased the risk of suffering from nipple erythema and skin irritation, but there were no significant differences for any other adverse events (all P > 0.05).
Conclusions
The currently available evidence suggests good efficacy of tamoxifen for the prevention and treatment of breast events induced by non-steroidal antiandrogens. The impact of tamoxifen therapy on long-term adverse events, disease progression and survival remains unclear. Further large, well-designed RCTs, including long-term follow-ups, are warranted. Also, the optimal dose needs to be clarified.
doi:10.1186/1741-7015-10-96
PMCID: PMC3464149  PMID: 22925442
Prostatic neoplasms; Androgen suppression therapy; Gynecomastia; Tamoxifen; Systematic review; Meta-analysis
7.  Effects of assessing the productivity of faculty in academic medical centres: a systematic review 
Background:
Many academic medical centres have introduced strategies to assess the productivity of faculty as part of compensation schemes. We conducted a systematic review of the effects of such strategies on faculty productivity.
Methods:
We searched the MEDLINE, Healthstar, Embase and PsycInfo databases from their date of inception up to October 2011. We included studies that assessed academic productivity in clinical, research, teaching and administrative activities, as well as compensation, promotion processes and satisfaction.
Results:
Of 531 full-text articles assessed for eligibility, we included 9 articles reporting on eight studies. The introduction of strategies for assessing academic productivity as part of compensation schemes resulted in increases in clinical productivity (in six of six studies) in terms of clinical revenue, the work component of relative-value units (these units are nonmonetary standard units of measure used to indicate the value of services provided), patient satisfaction and other departmentally used standards. Increases in research productivity were noted (in five of six studies) in terms of funding and publications. There was no change in teaching productivity (in two of five studies) in terms of educational output. Such strategies also resulted in increases in compensation at both individual and group levels (in three studies), with two studies reporting a change in distribution of compensation in favour of junior faculty. None of the studies assessed effects on administrative productivity or promotion processes. The overall quality of evidence was low.
Interpretation:
Strategies introduced to assess productivity as part of a compensation scheme appeared to improve productivity in research activities and possibly improved clinical productivity, but they had no effect in the area of teaching. Compensation increased at both group and individual levels, particularly among junior faculty. Higher quality evidence about the benefits and harms of such assessment strategies is needed.
doi:10.1503/cmaj.111123
PMCID: PMC3414625  PMID: 22641686
8.  Scientific Value of Systematic Reviews: Survey of Editors of Core Clinical Journals 
PLoS ONE  2012;7(5):e35732.
Background
Synthesizing research evidence using systematic and rigorous methods has become a key feature of evidence-based medicine and knowledge translation. Systematic reviews (SRs) may or may not include a meta-analysis depending on the suitability of available data. They are often being criticised as ‘secondary research’ and denied the status of original research. Scientific journals play an important role in the publication process. How they appraise a given type of research influences the status of that research in the scientific community. We investigated the attitudes of editors of core clinical journals towards SRs and their value for publication.
Methods
We identified the 118 journals labelled as “core clinical journals” by the National Library of Medicine, USA in April 2009. The journals’ editors were surveyed by email in 2009 and asked whether they considered SRs as original research projects; whether they published SRs; and for which section of the journal they would consider a SR manuscript.
Results
The editors of 65 journals (55%) responded. Most respondents considered SRs to be original research (71%) and almost all journals (93%) published SRs. Several editors regarded the use of Cochrane methodology or a meta-analysis as quality criteria; for some respondents these criteria were premises for the consideration of SRs as original research. Journals placed SRs in various sections such as “Review” or “Feature article”. Characterization of non-responding journals showed that about two thirds do publish systematic reviews.
Discussion
Currently, the editors of most core clinical journals consider SRs original research. Our findings are limited by a non-responder rate of 45%. Individual comments suggest that this is a grey area and attitudes differ widely. A debate about the definition of ‘original research’ in the context of SRs is warranted.
doi:10.1371/journal.pone.0035732
PMCID: PMC3341385  PMID: 22563469
9.  Do urology journals enforce trial registration? A cross-sectional study of published trials 
BMJ Open  2011;1(2):e000430.
Objectives
(1) To assess endorsement of trial registration in author instructions of urology-related journals and (2) to assess whether randomised controlled trials (RCTs) in the field of urology were effectively registered.
Design
Cross-sectional study of author instructions and published trials.
Setting
Journals publishing in the field of urology.
Participants
First, the authors analysed author instructions of 55 urology-related journals indexed in ‘Journal Citation Reports 2009’ (12/2010). The authors divided these journals in two groups: those requiring and those not mentioning trial registration as a precondition for publication. Second, the authors chose the five journals with the highest impact factor (IF) from each group.
Intervention
MEDLINE search to identify RCTs published in these 10 journals in 2009 (01/2011); search of the clinical trials meta-search interface of WHO (International Clinical Trials Registry Platform) for RCTs that lacked information about registration (01–03/2011). Two authors independently assessed the information.
Outcome measures
Proportion of journals providing advice about trial registration and proportion of trials registered.
Results
Of 55 journals analysed, 26 (47.3%) provided some editorial advice about trial registration. Journals with higher IFs were more likely to mention trial registration explicitly (p=0.015). Of 106 RCTs published in 2009, 63 were registered (59.4%) with a tendency to an increase after 2005 (83.3%, p=0.035). 71.4% (30/42) of the RCTs that were published in journals mentioning and requiring registration, and 51.6% (33/64) of the RCTs that were published in journals that did not mention trial registration explicitly were registered. This difference was statistically significant (p=0.04).
Conclusions
The existence of a statement about trial registration in author instructions resulted in a higher proportion of registered RCTs in those journals. Journals with higher IFs were more likely to mention trial registration.
Article summary
Article focus
Trial registration can increase scientific transparency, but its implementation in specialty fields such as urology is unclear.
To assess the endorsement of trial registration in the author instructions of urology-related journals.
To assess whether randomised controlled trials in the field were effectively registered.
Key messages
A statement of trial registration in author instructions resulted in a higher proportion of registered randomised controlled trials.
Journals with high impact factors were more likely to mention trial registration.
We suggest, though, that ensuring trial registration is not the responsibility only of the editors. Medical scientists should realise that trial registration is necessary to contribute to transparency in research.
Strength and limitations of this study
Two authors independently assessed information regarding editorial advice about trial registration and identified the randomised controlled trials.
Potential bias occurred if registered randomised controlled trials were reported without giving a registration number and we could not identify them in the meta-search interface of WHO (International Clinical Trials Registry Platform).
Results might not be representative of the uro-nephrological field as a whole and reported figures may overestimate compliance with trial registration.
doi:10.1136/bmjopen-2011-000430
PMCID: PMC3236819  PMID: 22146890
10.  Are pediatric Open Access journals promoting good publication practice? An analysis of author instructions 
BMC Pediatrics  2011;11:27.
Background
Several studies analyzed whether conventional journals in general medicine or specialties such as pediatrics endorse recommendations aiming to improve publication practice. Despite evidence showing benefits of these recommendations, the proportion of endorsing journals has been moderate to low and varied considerably for different recommendations. About half of pediatric journals indexed in the Journal Citation Report referred to the Uniform Requirements for Manuscripts of the International Committee of Medical Journal Editors (ICMJE) but only about a quarter recommended registration of trials. We aimed to investigate to what extent pediatric open-access (OA) journals endorse these recommendations. We hypothesized that a high proportion of these journals have adopted recommendations on good publication practice since OA electronic publishing has been associated with a number of editorial innovations aiming at improved access and transparency.
Methods
We identified 41 journals publishing original research in the subject category "Health Sciences, Medicine (General), Pediatrics" of the Directory of Open Access Journals http://www.doaj.org. From the journals' online author instructions we extracted information regarding endorsement of four domains of editorial policy: the Uniform Requirements for Manuscripts, trial registration, disclosure of conflicts of interest and five major reporting guidelines such as the CONSORT (Consolidated Standards of Reporting Trials) statement. Two investigators collected data independently.
Results
The Uniform Requirements were mentioned by 27 (66%) pediatric OA journals. Thirteen (32%) required or recommended trial registration prior to publication of a trial report. Conflict of interest policies were stated by 25 journals (61%). Advice about reporting guidelines was less frequent: CONSORT was referred to by 12 journals (29%) followed by other reporting guidelines (MOOSE, PRISMA or STARD) (8 journals, 20%) and STROBE (3 journals, 7%). The EQUATOR network, a platform of several guideline initiatives, was acknowledged by 4 journals (10%).
Journals published by OA publishing houses gave more guidance than journals published by professional societies or other publishers.
Conclusions
Pediatric OA journals mentioned certain recommendations such as the Uniform Requirements or trial registration more frequently than conventional journals; however, endorsement is still only moderate. Further research should confirm these exploratory findings in other medical fields and should clarify what the motivations and barriers are in implementing such policies.
doi:10.1186/1471-2431-11-27
PMCID: PMC3084157  PMID: 21477335
11.  Reporting of eligibility criteria of randomised trials: cohort study comparing trial protocols with subsequent articles 
Objective To determine whether and how eligibility criteria of participants prespecified in protocols of randomised trials are reported in subsequent articles.
Design Cohort study.
Setting Protocols submitted to the ethics committee of a German medical faculty.
Data sources 52 trial protocols and 78 subsequent publications published between 2000 and 2006.
Main outcome measure Proportion of matching, missing, modified, or newly added eligibility criteria between trial protocols and subsequent publications.
Results Differences were found between protocols and subsequent publications for all 52 trials. Information on eligibility criteria was missing in the publications for all 52 trials (100%, 95% confidence interval 93% to 100%), modified for 44 (85%, 72% to 93%), and newly added for 21 (41%, 27% to 55%). The mean number of eligibility criteria for each trial was 25 (range 7-43) and the mean proportion of matching eligibility criteria per trial was 50% (95% confidence interval 44% to 55%, range 13-93). Of 1248 eligibility criteria prespecified in the protocols, 606 (49%, 46% to 51%) were matching in subsequent publications, 479 (38%, 36% to 41%) were missing, and 163 (13%, 11% to 15%) were modified. 51 eligibility criteria were added to publications. Most prespecified eligibility criteria were about comorbidity (42%, 39% to 45%), treatment (20%, 18% to 22%), or type or severity of illness (17%, 15% to 19%). Most of the missing eligibility criteria (96%, 94% to 97%) and modified eligibility criteria (54%, 46% to 62%) suggested broader study populations and most of the added eligibility criteria (86%, 74% to 94%) suggested narrower study populations.
Conclusions Many users of trial information rely on published journal articles. These articles generally do not reflect the exact definition of the study population as prespecified in the protocol. Incomplete or inadequate reporting of eligibility criteria hampers a proper assessment of the applicability of trial results.
doi:10.1136/bmj.d1828
PMCID: PMC3071036  PMID: 21467104
12.  Initiation and continuation of randomized trials after the publication of a trial stopped early for benefit asking the same study question: STOPIT-3 study design 
Trials  2013;14:335.
Background
Randomized control trials (RCTs) stopped early for benefit (truncated RCTs) are increasingly common and, on average, overestimate the relative magnitude of benefit by approximately 30%. Investigators stop trials early when they consider it is no longer ethical to enroll patients in a control group. The goal of this systematic review is to determine how investigators of ongoing or planned RCTs respond to the publication of a truncated RCT addressing a similar question.
Methods/design
We will conduct systematic reviews to update the searches of 210 truncated RCTs to identify similar trials ongoing at the time of publication, or started subsequently, to the truncated trials ('subsequent RCTs’). Reviewers will determine in duplicate the similarity between the truncated and subsequent trials. We will analyze the epidemiology, distribution, and predictors of subsequent RCTs. We will also contact authors of subsequent trials to determine reasons for beginning, continuing, or prematurely discontinuing their own trials, and the extent to which they rely on the estimates from truncated trials.
Discussion
To the extent that investigators begin or continue subsequent trials they implicitly disagree with the decision to stop the truncated RCT because of an ethical mandate to administer the experimental treatment. The results of this study will help guide future decisions about when to stop RCTs early for benefit.
doi:10.1186/1745-6215-14-335
PMCID: PMC3874848  PMID: 24131702
Randomized controlled trials stopped early for benefit; RCT; Systematic review; Protocol
13.  Defining publication bias: protocol for a systematic review of highly cited articles and proposal for a new framework 
Systematic Reviews  2013;2:34.
Background
Selective publication of studies, which is commonly called publication bias, is widely recognized. Over the years a new nomenclature for other types of bias related to non-publication or distortion related to the dissemination of research findings has been developed. However, several of these different biases are often still summarized by the term 'publication bias'.
Methods/Design
As part of the OPEN Project (To Overcome failure to Publish nEgative fiNdings) we will conduct a systematic review with the following objectives:
- To systematically review highly cited articles that focus on non-publication of studies and to present the various definitions of biases related to the dissemination of research findings contained in the articles identified.
- To develop and discuss a new framework on nomenclature of various aspects of distortion in the dissemination process that leads to public availability of research findings in an international group of experts in the context of the OPEN Project.
We will systematically search Web of Knowledge for highly cited articles that provide a definition of biases related to the dissemination of research findings. A specifically designed data extraction form will be developed and pilot-tested. Working in teams of two, we will independently extract relevant information from each eligible article.
For the development of a new framework we will construct an initial table listing different levels and different hazards en route to making research findings public. An international group of experts will iteratively review the table and reflect on its content until no new insights emerge and consensus has been reached.
Discussion
Results are expected to be publicly available in mid-2013. This systematic review together with the results of other systematic reviews of the OPEN project will serve as a basis for the development of future policies and guidelines regarding the assessment and prevention of publication bias.
doi:10.1186/2046-4053-2-34
PMCID: PMC3667005  PMID: 23692820
Publication bias; Full publication; Underreporting; New framework; The OPEN project
14.  A protocol for a systematic review on the impact of unpublished studies and studies published in the gray literature in meta-analyses 
Systematic Reviews  2013;2:24.
Background
Meta-analyses are particularly vulnerable to the effects of publication bias. Despite methodologists’ best efforts to locate all evidence for a given topic the most comprehensive searches are likely to miss unpublished studies and studies that are published in the gray literature only. If the results of the missing studies differ systematically from the published ones, a meta-analysis will be biased with an inaccurate assessment of the intervention’s effects.
As part of the OPEN project (http://www.open-project.eu) we will conduct a systematic review with the following objectives:
▪ To assess the impact of studies that are not published or published in the gray literature on pooled effect estimates in meta-analyses (quantitative measure).
▪ To assess whether the inclusion of unpublished studies or studies published in the gray literature leads to different conclusions in meta-analyses (qualitative measure).
Methods/Design
Inclusion criteria: Methodological research projects of a cohort of meta-analyses which compare the effect of the inclusion or exclusion of unpublished studies or studies published in the gray literature.
Literature search: To identify relevant research projects we will conduct electronic searches in Medline, Embase and The Cochrane Library; check reference lists; and contact experts.
Outcomes: 1) The extent to which the effect estimate in a meta-analyses changes with the inclusion or exclusion of studies that were not published or published in the gray literature; and 2) the extent to which the inclusion of unpublished studies impacts the meta-analyses’ conclusions.
Data collection: Information will be collected on the area of health care; the number of meta-analyses included in the methodological research project; the number of studies included in the meta-analyses; the number of study participants; the number and type of unpublished studies; studies published in the gray literature and published studies; the sources used to retrieve studies that are unpublished, published in the gray literature, or commercially published; and the validity of the methodological research project.
Data synthesis: Data synthesis will involve descriptive and statistical summaries of the findings of the included methodological research projects.
Discussion
Results are expected to be publicly available in the middle of 2013.
doi:10.1186/2046-4053-2-24
PMCID: PMC3682918  PMID: 23634657
Publication bias; Gray literature; Unpublished studies; Meta-analyses; The OPEN project
15.  Early versus deferred androgen suppression therapy for patients with lymph node-positive prostate cancer after local therapy with curative intent: a systematic review 
BMC Cancer  2013;13:131.
Background
There is currently no consensus regarding the optimal timing for androgen suppression therapy in patients with prostate cancer that have undergone local therapy with curative intent but are proven to have node-positive disease without signs of distant metastases at the time of local therapy. The objective of this systematic review was to determine the benefits and harms of early (at the time of local therapy) versus deferred (at the time of clinical disease progression) androgen suppression therapy for patients with node-positive prostate cancer after local therapy.
Methods
The protocol was registered prospectively (CRD42011001221; http://www.crd.york.ac.uk/PROSPERO). We searched the MEDLINE, EMBASE, and CENTRAL databases, as well as reference lists, the abstracts of three major conferences, and three trial registers, to identify randomized controlled trials (search update 04/08/2012). Two authors independently screened the identified articles, assessed trial quality, and extracted data.
Results
Four studies including 398 patients were identified for inclusion. Early androgen suppression therapy lead to a significant decrease in overall mortality (HR 0.62, 95% CI 0.46-0.84), cancer-specific mortality (HR 0.34, 95% CI 0.18-0.64), and clinical progression at 3 or 9 years (RR 0.29, 95% CI 0.16-0.52 at 3 years and RR 0.49, 95% CI 0.36-0.67 at 9 years). One study showed an increase of adverse effects with early androgen suppression therapy. All trials had substantial methodological limitations.
Conclusions
The data available suggest an improvement in survival and delayed disease progression but increased adverse events for patients with node-positive prostate cancer after local therapy treated with early androgen suppression therapy versus deferred androgen suppression therapy. However, quality of data is low. Randomized controlled trials with blinding of outcome assessment, planned to determine the timing of androgen suppression therapy in node-positive prostate cancer using modern diagnostic imaging modalities, biochemical testing, and standardized follow-up schedules should be conducted to confirm these findings.
doi:10.1186/1471-2407-13-131
PMCID: PMC3621662  PMID: 23510155
Prostatic neoplasms; Lymphatic metastasis; Lymph node excision; Androgen suppression therapy; Systematic review; Meta-analysis
16.  Protocol for a systematic review on the extent of non-publication of research studies and associated study characteristics 
Systematic Reviews  2013;2:2.
Background
Methodological research has found that non-published studies often have different results than those that are published, a phenomenon known as publication bias. When results are not published, or are published selectively based on the direction or the strength of the findings, healthcare professionals and consumers of healthcare cannot base their decision-making on the full body of current evidence.
Methods
As part of the OPEN project (http://www.open-project.eu) we will conduct a systematic review with the following objectives:
1. To determine the proportion and/or rate of non-publication of studies by systematically reviewing methodological research projects that followed up a cohort of studies that
a. received research ethics committee (REC) approval,
b. were registered in trial registries, or
c. were presented as abstracts at conferences.
2. To assess the association of study characteristics (for example, direction and/or strength of findings) with likelihood of full publication.
To identify reports of relevant methodological research projects we will conduct electronic database searches, check reference lists, and contact experts. Published and unpublished projects will be included. The inclusion criteria are as follows:
a. RECs: methodological research projects that examined the subsequent proportion and/or rate of publication of studies that received approval from RECs;
b. Trial registries: methodological research projects that examine the subsequent proportion and/or rate of publication of studies registered in trial registries;
c. Conference abstracts: methodological research projects that examine the subsequent proportion and/or rate of full publication of studies which were initially presented at conferences as abstracts.
Primary outcomes: Proportion/rate of published studies; time to full publication (mean/median; cumulative publication rate by time).
Secondary outcomes: Association of study characteristics with full publication.
The different questions (a, b, and c) will be investigated separately. Data synthesis will involve a combination of descriptive and statistical summaries of the included methodological research projects.
Discussion
Results are expected to be publicly available in mid 2013.
doi:10.1186/2046-4053-2-2
PMCID: PMC3577647  PMID: 23302739
Publication bias; Selective reporting; Abstract(s); Research ethics committees; Trial registration; The OPEN Project

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