Search

Open Peer Review is gaining prominence in attention and use, but to responsibly open up peer review, there is an urgent need for additional evidence. Here, we propose a preliminary research agenda and issue a call to action. Open Peer Review is gaining prominence in attention and use, but to responsibly open up peer review there is an urgent need for additional evidence. This Perspective proposes a preliminary research agenda and issues a call-to-action. [ABSTRACT FROM AUTHOR]

Various stakeholders in science have put research integrity high on their agenda. Among them, research funders are prominently placed to foster research integrity by requiring that the organizations and individual researchers they support make an explicit commitment to research integrity. Moreover, funders need to adopt appropriate research integrity practices themselves. To facilitate this, we recommend that funders develop and implement a Research Integrity Promotion Plan (RIPP). This Consensus View offers a range of examples of how funders are already promoting research integrity, distills 6 core topics that funders should cover in a RIPP, and provides guidelines on how to develop and implement a RIPP. We believe that the 6 core topics we put forward will guide funders towards strengthening research integrity policy in their organization and guide the researchers and research organizations they fund. Research funders are prominently placed to foster research integrity by requiring that researchers make an explicit commitment to research integrity. This Consensus View suggests 6 core topics that funders should cover in a research integrity promotion plan and provides practical recommendations for how to implement one. [ABSTRACT FROM AUTHOR]

For more than 25 years, research misconduct (research fraud) is defined as fabrication, falsification, or plagiarism (FFP)—although other research misbehaviors have been also added in codes of conduct and legislations. A critical issue in deciding whether research misconduct should be subject to criminal law is its definition, because not all behaviors labeled as research misconduct qualifies as serious crime. But assuming that all FFP is fraud and all non-FFP not is far from obvious. In addition, new research misbehaviors have recently been described, such as prolific authorship, and fake peer review, or boosted such as duplication of images. The scientific community has been largely successful in keeping criminal law away from the cases of research misconduct. Alleged cases of research misconduct are usually looked into by committees of scientists usually from the same institution or university of the suspected offender in a process that often lacks transparency. Few countries have or plan to introduce independent bodies to address research misconduct; so for the coming years, most universities and research institutions will continue handling alleged research misconduct cases with their own procedures. A global operationalization of research misconduct with clear boundaries and clear criteria would be helpful. There is room for improvement in reaching global clarity on what research misconduct is, how allegations should be handled, and which sanctions are appropriate. [ABSTRACT FROM AUTHOR]

Publications determine to a large extent the possibility to stay in academia (“publish or perish”). While some pressure to publish may incentivise high quality research, too much publication pressure is likely to have detrimental effects on both the scientific enterprise and on individual researchers. Our research question was: What is the level of perceived publication pressure in the four academic institutions in Amsterdam and does the pressure to publish differ between academic ranks and disciplinary fields? Investigating researchers in Amsterdam with the revised Publication Pressure Questionnaire, we find that a negative attitude towards the current publication climate is present across academic ranks and disciplinary fields. Postdocs and assistant professors (M = 3.42) perceive the greatest publication stress and PhD-students (M = 2.44) perceive a significant lack of resources to relieve publication stress. Results indicate the need for a healthier publication climate where the quality and integrity of research is rewarded. [ABSTRACT FROM AUTHOR]

Background: Personality influences decision making and ethical considerations. Its influence on the occurrence of research misbehavior has never been studied. This study aims to determine the association between personality traits and self-reported questionable research practices and research misconduct. We hypothesized that narcissistic, Machiavellianistic and psychopathic traits as well as self-esteem are associated with research misbehavior. Methods: Included in this cross-sectional study design were 535 Dutch biomedical scientists (response rate 65%) from all hierarchical layers of 4 university medical centers in the Netherlands. We used validated personality questionnaires such as the Dark Triad (narcissism, psychopathy, and Machiavellianism), Rosenberg's Self-Esteem Scale, the Publication Pressure Questionnaire (PPQ), and also demographic and job-specific characteristics to investigate the association of personality traits with a composite research misbehavior severity score. Findings: Machiavellianism was positively associated (beta 1.28, CI 1.06–1.53) with self-reported research misbehavior, while narcissism, psychopathy and self-esteem were not. Exploratory analysis revealed that narcissism and research misconduct were more severe among persons in higher academic ranks (i.e., professors) (p<0.01 and p<0.001, respectively), and self-esteem scores and publication pressure were lower (p<0.001 and p<0.01, respectively) as compared to postgraduate PhD fellows. Conclusions: Machiavellianism may be a risk factor for research misbehaviour. Narcissism and research misbehaviour were more prevalent among biomedical scientists in higher academic positions. These results suggest that personality has an impact on research behavior and should be taken into account in fostering responsible conduct of research. [ABSTRACT FROM AUTHOR]

The objective of this study is to provide a critical overview of available instruments to assess impairments in patients with rheumatic disorders, and to recommend reliable and valid instruments for use in allied health care and rehabilitation medicine. A computer-aided literature search (1982–2004) in several databases was performed to identify studies focusing on the clinimetric properties of instruments designed to assess impairments in function in patients with rheumatic disorders. Data on intra-rater reliability, inter-rater reliability and construct validity were extracted in a standardized way. Explicit criteria were applied for reliability and validity. Results: The search identified a total of 49 instruments to assess impairments in functions in patients with rheumatic disorders; 19 met the criteria for reliability, 22 met the criteria for validity, and 11 out of the 49 appeared to meet the criteria for both reliability and validity. In summary, evidence of both reliability and validity was only found for 11 out of 49 instruments for the assessment of impairments in patients with rheumatic disorders. Only a limited number of the identified instruments for the assessment of impairments is both reliable and valid. Allied health care professionals should be cautious in the selection of measurement instruments to assess their patients. [ABSTRACT FROM AUTHOR]

Presents a study to test whether overweight and obesity are associated with low-grade systematic inflammation as measured by serum C-reactive protein (CRP) level. Context; Design and setting; Participants; Main outcome measures; Results; Conclusion.

Background. Spinal manipulative therapy (SMT) is a frequently applied therapy for back and neck pain. Serious complications of SMT are presented primarily in case reports. Many patients seen by physicians also seek care from therapists applying manipulative techniques. Therefore, background information on the risks of SMT is essential for physicians. Methods. Relevant case reports, surveys, and review articles were identified using a comprehensive search of online and bibliographical databases. For every case, a record was made of first author, publication year, country, age and sex of the patient, background of the manipulator, preexisting conditions, type of complication, and course of the complication. Based on ease reports and surveys, an estimation was made of the risk for the most frequently reported complications: vertebrobasilar accidents (VBAs) and cauda equina syndrome (CES). Results. We derived 295 complications of spinal manipulations from the literature: 165 VBAs; 61 eases with disc herniation or progression to CES; 13 cerebral complications other than VBAs; and 56 other types of complications. The average age of patients with VBA was 38 years. Vertebrobasilar accidents occur mainly after a cervical manipulation with a rotatory component. Estimates of VBA range from 1 per 20,000 patients to 1 per 1 million cervical manipulations. The incidence of CHS is estimated to be less than 1 per 1 million treatments. Conclusions. It is difficult to estimate the incidence of SMT complications, as they are probably underreported in the literature. Most non-VBA complications can be prevented by excluding patients with contraindications for SMT. Patients who develop complications such as CES should be treated as soon as possible. VBAs, however, are difficult to prevent and treat. Referral for SMT should not he made to practitioners applying rotator) cervical manipulation. Information about the risk of VBA should be included in m informed consent procedure for cervical manipulation with thrust techniques. [ABSTRACT FROM AUTHOR]

Examines the effectiveness of manipulative and physiotherapy for back and neck complaints among patients in the Netherlands. Receipt of other treatment forms during follow ups; Levels of improvement in main complaint; Advantages of manipulative therapy.

Background: Problems continue to exist with the reporting quality and risk of bias in search methods and strategies in systematic reviews and related review types. Peer reviewers who are not familiar with what is required to transparently and fully report a search may not be prepared to review the search components of systematic reviews, nor may they know what is likely to introduce bias into a search. Librarians and information specialists, who have expertise in searching, may offer specialized knowledge that would help improve systematic review search reporting and lessen risk of bias, but they are underutilized as methodological peer reviewers.Methods: This study will evaluate the effect of adding librarians and information specialists as methodological peer reviewers on the quality of search reporting and risk of bias in systematic review searches. The study will be a pragmatic randomized controlled trial using 150 systematic review manuscripts submitted to BMJ and BMJ Open as the unit of randomization. Manuscripts that report on completed systematic reviews and related review types and have been sent for peer review are eligible. For each manuscript randomized to the intervention, a librarian/information specialist will be invited as an additional peer reviewer using standard practices for each journal. First revision manuscripts will be assessed in duplicate for reporting quality and risk of bias, using adherence to 4 items from PRISMA-S and assessors' judgements on 4 signaling questions from ROBIS Domain 2, respectively. Identifying information from the manuscripts will be removed prior to assessment.Discussion: The primary outcomes for this study are quality of reporting as indicated by differences in the proportion of adequately reported searches in first revision manuscripts between intervention and control groups and risk of bias as indicated by differences in the proportions of first revision manuscripts with high, low, and unclear bias. If the intervention demonstrates an effect on search reporting or bias, this may indicate a need for journal editors to work with librarians and information specialists as methodological peer reviewers.Trial Registration: Open Science Framework. Registered on June 17, 2021, at https://doi.org/10.17605/OSF.IO/W4CK2 . [ABSTRACT FROM AUTHOR]

We call on research funding organisations to experiment with different models for integrating partial randomisation into their grant allocation processes as well as to assess the feasibility, the potential implications, and the perceptions of such models. Traditional models of grant allocation have usually been based on peer review to rank applications and allocate grants. These models have been shown to suffer from various shortcomings. In particular, we believe that partial randomisation holds the potential of being more fair, more efficient, and more diverse. In addition, it may lead to more responsible research practices. We outline a proposal for such a grant allocation process and sketch various arguments in favour of it. We also address potential counterarguments and conclude that partial randomisation in grant allocation holds the potential to lead to many benefits and therefore warrants further experimentation and implementation. [ABSTRACT FROM AUTHOR]

The author discusses the seven biggest problems facing science. The author mentions that problems include shortage of research funds, poor study design, failing peer review, and lack of replicability. The author believes that responsible research practices must be fostered through offering education, effective regulations, and reform in the system. He also cites the importance of the 5th World Conference on Research Integrity in addressing the lapses of integrity.

Background: COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) is an initiative of an international multidisciplinary team of researchers who aim to improve the selection of outcome measurement instruments both in research and in clinical practice by developing tools for selecting the most appropriate available instrument. Method: In this paper these tools are described, i.e. the COSMIN taxonomy and definition of measurement properties; the COSMIN checklist to evaluate the methodological quality of studies on measurement properties; a search filter for finding studies on measurement properties; a protocol for systematic reviews of outcome measurement instruments; a database of systematic reviews of outcome measurement instruments; and a guideline for selecting outcome measurement instruments for Core Outcome Sets in clinical trials. Currently, we are updating the COSMIN checklist, particularly the standards for content validity studies. Also new standards for studies using Item Response Theory methods will be developed. Additionally, in the future we want to develop standards for studies on the quality of non-patient reported outcome measures, such as clinician-reported outcomes and performance-based outcomes. Conclusions: In summary, we plea for more standardization in the use of outcome measurement instruments, for conducting high quality systematic reviews on measurement instruments in which the best available outcome measurement instrument is recommended, and for stopping the use of poor outcome measurement instruments. [ABSTRACT FROM AUTHOR]

Prevalence of research misconduct, questionable research practices (QRPs) and their associations with a range of explanatory factors has not been studied sufficiently among academic researchers. The National Survey on Research Integrity targeted all disciplinary fields and academic ranks in the Netherlands. It included questions about engagement in fabrication, falsification and 11 QRPs over the previous three years, and 12 explanatory factor scales. We ensured strict identity protection and used the randomized response method for questions on research misconduct. 6,813 respondents completed the survey. Prevalence of fabrication was 4.3% (95% CI: 2.9, 5.7) and of falsification 4.2% (95% CI: 2.8, 5.6). Prevalence of QRPs ranged from 0.6% (95% CI: 0.5, 0.9) to 17.5% (95% CI: 16.4, 18.7) with 51.3% (95% CI: 50.1, 52.5) of respondents engaging frequently in at least one QRP. Being a PhD candidate or junior researcher increased the odds of frequently engaging in at least one QRP, as did being male. Scientific norm subscription (odds ratio (OR) 0.79; 95% CI: 0.63, 1.00) and perceived likelihood of detection by reviewers (OR 0.62, 95% CI: 0.44, 0.88) were associated with engaging in less research misconduct. Publication pressure was associated with more often engaging in one or more QRPs frequently (OR 1.22, 95% CI: 1.14, 1.30). We found higher prevalence of misconduct than earlier surveys. Our results suggest that greater emphasis on scientific norm subscription, strengthening reviewers in their role as gatekeepers of research quality and curbing the "publish or perish" incentive system promotes research integrity. [ABSTRACT FROM AUTHOR]

OBJECTIVES: To estimate the maximum potential preventive effect of hip protectors in older persons living in the community or homes for the elderly. DESIGN: Observational cohort study. SETTING: Emergency departments in the Netherlands. PARTICIPANTS: Hip fracture patients aged 70 and older who visited the emergency departments of five hospitals in the Netherlands (n=520). MEASUREMENTS: Using the risk score of the Dutch Guidelines for Osteoporosis, how many patients had a high risk for fractures was retrospectively assessed. In addition, the circumstances of the hip fracture were assessed (n=299). Four factors were specified that might influence the maximum potential preventive effect of hip protectors: (1) hip fracture occurred in persons having a low risk, (2) hip fracture was not the consequence of a fall, (3) hip fracture occurred during circumstances that preclude the use of hip protectors, and (4) hip fracture occurred during the night. RESULTS: When providing hip protectors to women at high risk of fractures, 48.2% of all hip fractures could have been prevented. CONCLUSION: Many hip fractures occur in persons with a low risk for hip fracture or under circumstances that preclude the use of hip protectors. It was estimated that the maximum potential preventive effect of hip protectors is approximately 50% in older women living in the community or homes for the elderly. The actual preventive effect will be lower and depends on the acceptance and effectiveness of hip protectors and adherence to wearing them. [ABSTRACT FROM AUTHOR]

Objective: To summarize the research evidence available from systematic reviews of the efficacy of occupational therapy (OT) for practitioners, researchers, purchasing organizations and policy-makers. Data source: The search for systematic reviews was conducted in PubMed and the Cochrane Library (October 2004). Methods: The reviews included were those that utilized a systematic search for evidence with regard to OT for specific patient groups. Data were summarized for patient group, interventions, outcome domains, type of study designs included, method of data synthesis and conclusions. Results: Fourteen systematic reviews were included. Three reviews related to rheumatoid arthritis, four reviewed stroke and four focused on elderly people. Reviews of Parkinson's disease, multiple sclerosis, Huntington's disease, cerebral palsy and mental illnesses were also identified. The reviews of rheumatoid arthritis, stroke and elderly people showed evidence of the efficacy of OT in increasing functional abilities. Positive results were presented for quality of life and social participation in elderly people and stroke respectively. The efficacy of OT in all other patient groups is unknown due to insufficient evidence. Conclusion: This summary shows that elderly people and people with stroke or rheumatoid arthritis can expect to benefit from comprehensive OT. Evidence of the efficacy of specific interventions is sparse and should be addressed in future research. The evidence that does exist should be incorporated into OT practice. [ABSTRACT FROM AUTHOR]

Objective: occupational therapy might play an important role in maintaining independent living for community dwelling elderly people. The aim of this systematic review is to determine whether occupational therapy improves outcome for people who are ≥60 years and are living independently. Methods: an extensive search in MEDLINE, CINAHL, EMBASE, AMED and SCISEARCH until July 2002 was performed. Studies with controlled and uncontrolled designs were included. Six intervention categories were distinguished and individually analysed using a best-evidence synthesis, based on the type of design, the methodological quality, type of outcome measures and statistical significance of findings. Results: 17 studies were included, ten of which were randomised clinical trials. Six randomised clinical trials had a high methodological quality. Strong evidence is present for the efficacy of advising on assistive devices as part of a home hazards assessment on functional ability. There is some evidence for the efficacy of training of skills combined with a home hazard assessment in decreasing the incidence of falls in elderly people at high risk of falling. Some evidence is available for the efficacy of comprehensive occupational therapy on functional ability, social participation and quality of life. Insufficient evidence is present for the efficacy of counselling the primary caregiver of dementia patients about maintaining the patient's functional abilities. Conclusion: this review shows that occupational therapy interventions for community dwelling elderly people results in positive outcomes. Future research in the efficacy of occupational therapy in elderly patient groups such as people with dementia is recommended. Furthermore, research into tailoring interventions to the needs of elderly patients is recommended. [ABSTRACT FROM AUTHOR]

Objective. To assess whether radiographic examinations are necessary to evaluate (trends in) the prevalence of caries, a summary was made of data from epidemiological studies comparing the results of clinical and radiographic examinations in young populations.Method. A literature search yielded seven studies that met the inclusion criteria. A two-by-two table of radiographic versus clinical data was constructed for each study. These data were used to assess the radiographic and clinical prevalences and to find a conversion factor to calculate the total prevalence from the clinical prevalence.Results. In the approximal surfaces the radiographic prevalence was considerably higher than the clinical prevalence. The conversion factors to calculate the total prevalence from the clinical prevalence varied considerably across studies. In the occlusal surfaces the radiographic and clinical prevalences were about similar, but extra lesions were detected with both methods.Conclusion. To study trends in the prevalence of caries, radiographic examinations are not necessary but to assess the prevalence of caries they do have unknown additional value. To obtain a valid conversion factor for relevant patient categories, agreement between the results of radiographic and clinical examinations should be investigated in sub samples of epidemiological studies. [Copyright &y& Elsevier]

Objective: Occupational therapy (OT) for cerebral palsy focuses on the development of skills necessary for the performance of activities of daily living. The aim of this systematic review was to determine whether OT interventions improve outcome for children with cerebral palsy (CP). Methods: An extensive search in MEDLINE, CINAHL, EMBASE, AMED and SCISEARCH was performed. Studies with controlled and uncontrolled designs were included. Six intervention categories were distinguished and individually analysed using a best-evidence synthesis. This synthesis is based on the type of design, the methodological quality, the type of outcome measures and the statistical significance of the findings. Results: Seventeen studies were included in this review, seven of which were randomized controlled trials (RCTs). One RCT had a high methodological quality. The analyses resulted in insufficient evidence of the efficacy of occupational therapy in all intervention categories, due to the low methodological quality of studies presenting statistically nonsignificant results. Conclusion: Despite the reasonable number of studies identified, the inconclusive findings regarding the efficacy of occupational therapy for children with cerebral palsy may be a reflection of the difficulties in efficacy research in OT for children with CP. Future research should critically reflect on methodological issues. [ABSTRACT FROM AUTHOR]

Clinimetrics is a methodologic discipline that focuses on the quality of clinical measurements, for example, diagnostic characteristics and disease outcomes. Different clinimetric properties, such as reproducibility and responsiveness, are important in both the development and the evaluation of measurement instruments. This article presents a number of the current challenges in clinimetrics: there is much confusion with regard to terminology, clinimetric properties are population and situation-dependent, and the abundance of different measurement instruments in specific fields hampers the comparison of study results. Further challenges lie in the improvement of the quality of both the measurement instruments and the performance of the actual measurements, and the assessment of the suitability for use in clinical practice. From the perspective of evidence-based medicine, it is essential to have measurement instruments that make it possible to detect clinically relevant improvements that are due to diagnostic and therapeutic interventions. Close collaboration between clinicians, statisticians, epidemiologists, and psychologists is necessary to guarantee healthy future developments in clinimetrics, serving the needs of both clinical research and clinical practice. [Copyright &y& Elsevier]

Background: Although guidelines for critical appraisal of diagnostic research and meta-analyses have already been published, these may be difficult to understand for clinical researchers or do not provide enough detailed information. Methods: Development of guidelines based on a systematic review of the evidence in reports of systematic searches of the literature for diagnostic research, of methodological criteria to evaluate diagnostic research, of methods for statistical pooling of data on diagnostic accuracy, and of methods for exploring heterogeneity. Results: Guidelines for conducting diagnostic systematic reviews are presented in a stepwise fashion and are followed by comments providing further information. Examples are given using the results of two systematic reviews on the accuracy of the urine dipstick in the diagnosis of urinary tract infections, and on the accuracy of the straight-leg-raising test in the diagnosis of intervertebral disc hernia. [ABSTRACT FROM AUTHOR]

Background: A proposal to encourage the preregistration of research on research integrity was developed and adopted as the Amsterdam Agenda at the 5th World Conference on Research Integrity (Amsterdam, 2017). This paper reports on the degree to which abstracts of the 6th World Conference in Research Integrity (Hong Kong, 2019) reported on preregistered research. Methods: Conference registration data on participants presenting a paper or a poster at 6th WCRI were made available to the research team. Because the data set was too small for inferential statistics this report is limited to a basic description of results and some recommendations that should be considered when taking further steps to improve preregistration. Results: 19% of the 308 presenters preregistered their research. Of the 56 usable cases, less than half provided information on the six key elements of the Amsterdam Agenda. Others provided information that invalidated their data, such as an uninformative URL. There was no discernable difference between qualitative and quantitative research. Conclusions: Some presenters at the WCRI have preregistered their research on research integrity, but further steps are needed to increase frequency and completeness of preregistration. One approach to increase preregistration would be to make it a requirement for research presented at the World Conferences on Research Integrity. [ABSTRACT FROM AUTHOR]

Citing of previous publications is an important factor in knowledge development. Because of the great amount of publications available, only a selection of studies gets cited, for varying reasons. If the selection of citations is associated with study outcome this is called citation bias. We will study determinants of citation in a broader sense, including e.g. study design, journal impact factor or the funding source of the publication. As a case study we assess which factors drive citation in the human literature on phthalates, specifically the metabolite mono(2-ethylhexyl) phthalate (MEHP). A systematic literature search identified all relevant publications on human health effect of MEHP. Data on potential determinants of citation were extracted in duplo. Specialized software was used to create a citation network, including all potential citation pathways. Random effect logistic regression was used to assess whether these determinants influence the likelihood of citation. 112 Publications on MEHP were identified, with 5684 potential citation pathways of which 551 were actual citations. Reporting of a harmful point estimate, journal impact factor, authority of the author, a male corresponding author, research performed in North America and self-citation were positively associated with the likelihood of being cited. In the literature on MEHP, citation is mostly driven by a number of factors that are not related to study outcome. Although the identified determinants do not necessarily give strong indications of bias, it shows selective use of published literature for a variety of reasons. [ABSTRACT FROM AUTHOR]

Breaches of research integrity have shocked the academic community. Initially explanations were sought at the level of individual researchers but over time increased recognition emerged of the important role that the research integrity climate may play in influencing researchers’ (mis)behavior. In this study we aim to assess whether researchers from different academic ranks and disciplinary fields experience the research integrity climate differently. We sent an online questionnaire to academic researchers in Amsterdam using the Survey of Organizational Research Climate. Bonferroni corrected mean differences showed that junior researchers (PhD students, postdocs and assistant professors) perceive the research integrity climate more negatively than senior researchers (associate and full professors). Junior researchers note that their supervisors are less committed to talk about key research integrity principles compared to senior researchers (MD = -.39, CI = -.55, -.24). PhD students perceive more competition and suspicion among colleagues (MD = -.19, CI = -.35, -.05) than associate and full professors. We found that researchers from the natural sciences overall express a more positive perception of the research integrity climate. Researchers from social sciences as well as from the humanities perceive less fairness of their departments’ expectations in terms of publishing and acquiring funding compared to natural sciences and biomedical sciences (MD = -.44, CI = -.74, -.15; MD = -.36, CI = -.61, -.11). Results suggest that department leaders in the humanities and social sciences should do more to set fairer expectations for their researchers and that senior scientists should ensure junior researchers are socialized into research integrity practices and foster a climate in their group where suspicion among colleagues has no place. [ABSTRACT FROM AUTHOR]

This study describes the policies, submission requirements, and transparency in reporting and research integrity recommendations of academic preprint servers. [ABSTRACT FROM AUTHOR]

Background: Selective reporting is wasteful, leads to bias in the published record and harms the credibility of science. Studies on potential determinants of selective reporting currently lack a shared taxonomy and a causal framework. Objective: To develop a taxonomy of determinants of selective reporting in science. Design: Inductive qualitative content analysis of a random selection of the pertinent literature including empirical research and theoretical reflections. Methods: Using search terms for bias and selection combined with terms for reporting and publication, we systematically searched the PubMed, Embase, PsycINFO and Web of Science databases up to January 8, 2015. Of the 918 articles identified, we screened a 25 percent random selection. From eligible articles, we extracted phrases that mentioned putative or possible determinants of selective reporting, which we used to create meaningful categories. We stopped when no new categories emerged in the most recently analyzed articles (saturation). Results: Saturation was reached after analyzing 64 articles. We identified 497 putative determinants, of which 145 (29%) were supported by empirical findings. The determinants represented 12 categories (leaving 3% unspecified): focus on preferred findings (36%), poor or overly flexible research design (22%), high-risk area and its development (8%), dependence upon sponsors (8%), prejudice (7%), lack of resources including time (3%), doubts about reporting being worth the effort (3%), limitations in reporting and editorial practices (3%), academic publication system hurdles (3%), unfavorable geographical and regulatory environment (2%), relationship and collaboration issues (2%), and potential harm (0.4%). Conclusions: We designed a taxonomy of putative determinants of selective reporting consisting of 12 categories. The taxonomy may help develop theory about causes of selection bias and guide policies to prevent selective reporting. [ABSTRACT FROM AUTHOR]

The objective of this study was to investigate the occurrence and determinants of non-publication of clinical drug trials in the Netherlands.All clinical drug trials reviewed by the 28 Institutional Review Boards (IRBs) in the Netherlands in 2007 were followed-up from approval to publication. Candidate determinants were the sponsor, phase, applicant, centers, therapeutic effect expected, type of trial, approval status of the drug(s), drug type, participant category, oncology or other disease area, prospective registration, and early termination. The main outcome was publication as peer reviewed article. The percentage of trials that were published, crude and adjusted odds ratio (OR), and 95% confidence interval (CI) were used to quantify the associations between determinants and publication. In 2007, 622 clinical drug trials were reviewed by IRBs in the Netherlands. By the end of follow-up, 19 of these were rejected by the IRB, another 19 never started inclusion, and 10 were still running. Of the 574 trials remaining in the analysis, 334 (58%) were published as peer-reviewed article. The multivariable logistic regression model identified the following determinants with a robust, statistically significant association with publication: phase 2 (60% published; adjusted OR 2.6, 95% CI 1.1–5.9), phase 3 (73% published; adjusted OR 4.1, 95% CI 1.7–10.0), and trials not belonging to phase 1–4 (60% published; adjusted OR 3.2, 95% CI 1.5 to 6.5) compared to phase 1 trials (35% published); trials with a company or investigator as applicant (63% published) compared to trials with a Contract Research Organization (CRO) as applicant (50% published; adjusted OR 1.7; 95% CI 1.1–2.8); and multicenter trials also conducted in other EU countries (68% published; adjusted OR 2.2, 95% CI 1.1–4.4) or also outside the European Union (72% published; adjusted OR 2.0, 95% CI 1.0–4.0) compared to single-center trials (45% published). Trials that were not prospectively registered (48% published) had a lower likelihood of publication compared to prospectively registered trials (75% published; adjusted OR 0.5, 95% CI 0.3–0.8), as well as trials that were terminated early (33% published) compared to trials that were completed as planned (64% published; adjusted OR 0.2, 95% CI 0.1–0.3). The non-publication rate of clinical trials seems to have improved compared to previous inception cohorts, but is still far from optimal, in particular among phase 1, single-center, not prospectively registered, and early terminated trials. [ABSTRACT FROM AUTHOR]

BACKGROUND Recent systematic reviews of adjuvant acupuncture for IVF have pooled heterogeneous trials, without examining variables that might explain the heterogeneity. The aims of our meta-analysis were to quantify the overall pooled effects of adjuvant acupuncture on IVF clinical pregnancy success rates, and evaluate whether study design-, treatment- and population-related factors influence effect estimates. METHODS We included randomized controlled trials that compared needle acupuncture administered within 1 day of embryo transfer, versus sham acupuncture or no adjuvant treatment. Our primary outcome was clinical pregnancy rates. We obtained from all investigators additional methodological details and outcome data not included in their original publications. We analysed sham-controlled and no adjuvant treatment-controlled trials separately, but since there were no large or significant differences between these two subsets, we pooled all trials for subgroup analyses. We prespecified 11 subgroup variables (5 clinical and 6 methodological) to investigate sources of heterogeneity, using single covariate meta-regressions. RESULTS Sixteen trials (4021 participants) were included in the meta-analyses. There was no statistically significant difference between acupuncture and controls when combining all trials [risk ratio (RR) 1.12, 95% confidence interval (CI), 0.96–1.31; I2 = 68%; 16 trials; 4021 participants], or when restricting to sham-controlled (RR 1.02, 0.83–1.26; I2 = 66%; 7 trials; 2044 participants) or no adjuvant treatment-controlled trials (RR 1.22, 0.97–1.52; I2 = 67%; 9 trials; 1977 participants). The type of control used did not significantly explain the statistical heterogeneity (interaction P = 0.27). Baseline pregnancy rate, measured as the observed rate of clinical pregnancy in the control group of each trial, was a statistically significant effect modifier (interaction P < 0.001), and this covariate explained most of the heterogeneity of the effects of adjuvant acupuncture across all trials (adjusted R2 = 93%; I2 residual = 9%). Trials with lower control group rates of clinical pregnancy showed larger effects of adjuvant acupuncture (RR 1.53, 1.28–1.84; 7 trials; 1732 participants) than trials with higher control group rates of clinical pregnancy (RR 0.90, 0.80–1.01; 9 trials; 2289 participants). The asymmetric funnel plot showed a tendency for the intervention effects to be more beneficial in smaller trials. CONCLUSIONS We found no pooled benefit of adjuvant acupuncture for IVF. The subgroup finding of a benefit in trials with lower, but not higher, baseline pregnancy rates (the only statistically significant subgroup finding in our earlier review) has been confirmed in this update, and was not explained by any confounding variables evaluated. However, this baseline pregnancy rate subgroup finding among published trials requires further confirmation and exploration in additional studies because of the multiple subgroup tests conducted, the risk of unidentified confounders, the multiple different factors that determine baseline rates, and the possibility of publication bias. [ABSTRACT FROM PUBLISHER]

Context: Publication bias jeopardizes evidence-based medicine, mainly through biased literature syntheses. Publication bias may also affect laboratory animal research, but evidence is scarce. Objectives: To assess the opinion of laboratory animal researchers on the magnitude, drivers, consequences and potential solutions for publication bias. And to explore the impact of size of the animals used, seniority of the respondent, working in a for-profit organization and type of research (fundamental, pre-clinical, or both) on those opinions. Design: Internet-based survey. Setting: All animal laboratories in The Netherlands. Participants: Laboratory animal researchers. Main Outcome Measure(s): Median (interquartile ranges) strengths of beliefs on 5 and 10-point scales (1: totally unimportant to 5 or 10: extremely important). Results: Overall, 454 researchers participated. They considered publication bias a problem in animal research (7 (5 to 8)) and thought that about 50% (32-70) of animal experiments are published. Employees (n = 21) of for-profit organizations estimated that 10% (5 to 50) are published. Lack of statistical significance (4 (4 to 5)), technical problems (4 (3 to 4)), supervisors (4 (3 to 5)) and peer reviewers (4 (3 to 5)) were considered important reasons for non-publication (all on 5-point scales). Respondents thought that mandatory publication of study protocols and results, or the reasons why no results were obtained, may increase scientific progress but expected increased bureaucracy. These opinions did not depend on size of the animal used, seniority of the respondent or type of research. Conclusions: Non-publication of "negative" results appears to be prevalent in laboratory animal research. If statistical significance is indeed a main driver of publication, the collective literature on animal experimentation will be biased. This will impede the performance of valid literature syntheses. Effective, yet efficient systems should be explored to counteract selective reporting of laboratory animal research. [ABSTRACT FROM AUTHOR]

Abstract: Background and Objective: To identify the strategies used to deal with the clinical heterogeneity of interventions and multiple outcome measures used in Cochrane reviews on physiotherapy and occupational therapy. Methods: A search for systematic reviews on physiotherapy and occupational therapy in the Cochrane Library was performed. Data on the method of categorization of interventions, on measures, and on the method of data synthesis were systematically extracted. Results: 52 reviews were identified. In 22 (42%) reviews only one index intervention was evaluated, in the other 30 reviews index interventions were categorized. A large diversity in the number and type of outcome measures was found (median 6.5, range 1–23). In 48% of the reviews one or more primary outcome measures were defined. In 52% of the reviews no quantitative data synthesis was performed, whereas five different methods for qualitative data synthesis were applied in 11 reviews. Conclusions: Limitation to a few outcome measures and explicit procedures for the categorization of interventions might increase the transparency and reproducibility of systematic reviews on physiotherapy and occupational therapy. Qualitative data synthesis is not often applied, although it is a useful tool to summarize results if a quantitative synthesis is not appropriate. International consensus on a method for qualitative synthesis is clearly needed. [Copyright &y& Elsevier]

Abstract: Objectives: The fall risk profile developed in the Longitudinal Aging Study Amsterdam (LASA) identifies community-dwelling elderly at high risk for recurrent falling. This study assessed the predictive validity of this profile in older persons seeking care after a fall. Study Design and Setting: The LASA fall risk profile was completed for 408 persons of 65 years and older who consulted the emergency department or general practitioner after a fall. Falls were prospectively reported with a calendar during 1 year. Recurrent falling was defined as ≥2 falls within a period of 6 months. Results: During 1 year of followup, 76 (18.6%) participants became recurrent fallers. The area under the receiver operating characteristic curve was 0.65 (95% confidence interval [95% CI]: 0.58–0.72). At a cutoff value of 8, the sensitivity was 56.6% (CI: 51.8–61.4), the specificity was 71.4% (CI: 67.0–75.8), the positive predictive value was 34.1% (CI: 29.5–38.7), and the negative predictive value was 85.6% (CI: 82.2–89.0). Conclusion: The discriminative ability of the LASA fall risk profile was moderate. The predictive validity of the LASA fall risk profile to identify recurrent fallers is limited among older persons who consulted the emergency department or general practitioner after a fall. [ABSTRACT FROM AUTHOR]

The article presents a study which examined the effectiveness of a multifactorial intervention in older people with a high risk of recurrent falls. The trial was conducted at the geriatric outpatient clinic in the Netherlands from April 3, 2005 to July 21, 2008. The study concluded that the fall-prevention program does not help in reducing falls in high-risk, cognitively intact older persons.

Abstract: Objective: Lack of consensus on taxonomy, terminology, and definitions has led to confusion about which measurement properties are relevant and which concepts they represent. The aim was to clarify and standardize terminology and definitions of measurement properties by reaching consensus among a group of experts and to develop a taxonomy of measurement properties relevant for evaluating health instruments. Study Design and Setting: An international Delphi study with four written rounds was performed. Participating experts had a background in epidemiology, statistics, psychology, and clinical medicine. The panel was asked to rate their (dis)agreement about proposals on a five-point scale. Consensus was considered to be reached when at least 67% of the panel agreed. Results: Of 91 invited experts, 57 agreed to participate and 43 actually participated. Consensus was reached on positions of measurement properties in the taxonomy (68–84%), terminology (74–88%, except for structural validity [56%]), and definitions of measurement properties (68–88%). The panel extensively discussed the positions of internal consistency and responsiveness in the taxonomy, the terms “reliability” and “structural validity,” and the definitions of internal consistency and reliability. Conclusions: Consensus on taxonomy, terminology, and definitions of measurement properties was reached. Hopefully, this will lead to a more uniform use of terms and definitions in the literature on measurement properties. [Copyright &y& Elsevier]

Aim of the COSMIN study (COnsensus-based Standards for the selection of health status Measurement INstruments) was to develop a consensus-based checklist to evaluate the methodological quality of studies on measurement properties. We present the COSMIN checklist and the agreement of the panel on the items of the checklist. A four-round Delphi study was performed with international experts (psychologists, epidemiologists, statisticians and clinicians). Of the 91 invited experts, 57 agreed to participate (63%). Panel members were asked to rate their (dis)agreement with each proposal on a five-point scale. Consensus was considered to be reached when at least 67% of the panel members indicated ‘agree’ or ‘strongly agree’. Consensus was reached on the inclusion of the following measurement properties: internal consistency, reliability, measurement error, content validity (including face validity), construct validity (including structural validity, hypotheses testing and cross-cultural validity), criterion validity, responsiveness, and interpretability. The latter was not considered a measurement property. The panel also reached consensus on how these properties should be assessed. The resulting COSMIN checklist could be useful when selecting a measurement instrument, peer-reviewing a manuscript, designing or reporting a study on measurement properties, or for educational purposes. [ABSTRACT FROM AUTHOR]

The article presents a study which compares the effectiveness of behavioral graded activity (BGA) program with manual therapy (MT) in patients with subacute neck pain. It performed a clinical trial, which involves 146 patients with subacute neck pain and measured pain, disability, and Kinesiophobia using the Numerical Rating Scale, Neck Disability Index, and Tampa Scale respectively. Results show that the differences between MT and BGA program were marginal but not clinically relevant.

Background: The COSMIN checklist is a tool for evaluating the methodological quality of studies on measurement properties of health-related patient-reported outcomes. The aim of this study is to determine the inter-rater agreement and reliability of each item score of the COSMIN checklist (n = 114). Methods: 75 articles evaluating measurement properties were randomly selected from the bibliographic database compiled by the Patient-Reported Outcome Measurement Group, Oxford, UK. Raters were asked to assess the methodological quality of three articles, using the COSMIN checklist. In a one-way design, percentage agreement and intraclass kappa coefficients or quadratic-weighted kappa coefficients were calculated for each item. Results: 88 raters participated. Of the 75 selected articles, 26 articles were rated by four to six participants, and 49 by two or three participants. Overall, percentage agreement was appropriate (68% was above 80% agreement), and the kappa coefficients for the COSMIN items were low (61% was below 0.40, 6% was above 0.75). Reasons for low inter-rater agreement were need for subjective judgement, and accustom to different standards, terminology and definitions. Conclusions: Results indicated that raters often choose the same response option, but that it is difficult on item level to distinguish between articles. When using the COSMIN checklist in a systematic review, we recommend getting some training and experience, completing it by two independent raters, and reaching consensus on one final rating. Instructions for using the checklist are improved. [ABSTRACT FROM AUTHOR]

Background: The COSMIN checklist (COnsensus-based Standards for the selection of health status Measurement INstruments) was developed in an international Delphi study to evaluate the methodological quality of studies on measurement properties of health-related patient reported outcomes (HR-PROs). In this paper, we explain our choices for the design requirements and preferred statistical methods for which no evidence is available in the literature or on which the Delphi panel members had substantial discussion. Methods: The issues described in this paper are a reflection of the Delphi process in which 43 panel members participated. Results: The topics discussed are internal consistency (relevance for reflective and formative models, and distinction with unidimensionality), content validity (judging relevance and comprehensiveness), hypotheses testing as an aspect of construct validity (specificity of hypotheses), criterion validity (relevance for PROs), and responsiveness (concept and relation to validity, and (in) appropriate measures). Conclusions: We expect that this paper will contribute to a better understanding of the rationale behind the items, thereby enhancing the acceptance and use of the COSMIN checklist. [ABSTRACT FROM AUTHOR]

Abstract: Objective: Determining “minimally important change” (MIC) facilitates the interpretation of change scores on multi-item instruments. This article focuses on how MIC values should be interpreted when applied to individual patients. Study Design and Setting: The MIC value of a hypothetical questionnaire “Q” was determined in a sample of 400 patients who improved and 100 patients who did not improve, using the receiver operating characteristic (ROC) method, and three methods to quantify the uncertainty. Results: The MIC value on questionnaire Q was 10.5. Firstly, the 95% confidence interval (CI) of the MIC value (for questionnaire Q: 5.6–14.2) quantifies the uncertainty of the estimation of the MIC value. Secondly, “how sure we are that this MIC value holds for every patient” is quantified by the values for sensitivity (74%) and specificity (91%). Thirdly, the smallest detectable change (SDC) on questionnaire Q is calculated (16.0) to consider whether the MIC value (10.5) falls outside or within the measurement error. Conclusion: For application in clinical research and practice, MIC values are always considered at the individual level, but determined in groups of patients. The interpretation comes with different forms of uncertainty. To appreciate the uncertainty, knowledge of the underlying distributions of change scores is indispensable. [Copyright &y& Elsevier]

Abstract: Objective: Our purpose was to measure the agreement, reliability, construct validity, and feasibility of a measurement tool to assess systematic reviews (AMSTAR). Study Design and Setting: We randomly selected 30 systematic reviews from a database. Each was assessed by two reviewers using: (1) the enhanced quality assessment questionnaire (Overview of Quality Assessment Questionnaire [OQAQ]); (2) Sacks'' instrument; and (3) our newly developed measurement tool (AMSTAR). We report on reliability (interobserver kappas of the 11 AMSTAR items), intraclass correlation coefficients (ICCs) of the sum scores, construct validity (ICCs of the sum scores of AMSTAR compared with those of other instruments), and completion times. Results: The interrater agreement of the individual items of AMSTAR was substantial with a mean kappa of 0.70 (95% confidence interval [CI]: 0.57, 0.83) (range: 0.38–1.0). Kappas recorded for the other instruments were 0.63 (95% CI: 0.38, 0.78) for enhanced OQAQ and 0.40 (95% CI: 0.29, 0.50) for the Sacks'' instrument. The ICC of the total score for AMSTAR was 0.84 (95% CI: 0.65, 0.92) compared with 0.91 (95% CI: 0.82, 0.96) for OQAQ and 0.86 (95% CI: 0.71, 0.94) for the Sacks'' instrument. AMSTAR proved easy to apply, each review taking about 15 minutes to complete. Conclusions: AMSTAR has good agreement, reliability, construct validity, and feasibility. These findings need confirmation by a broader range of assessors and a more diverse range of reviews. [Copyright &y& Elsevier]

The article presents a study which examined the association between a common measure of internal validity and the magnitude of treatment effects in randomized controlled trials of low-back pain. The study used the 11-item Internal Validity Checklist of the Cochrane Back Review Group Editorial Board in the assessment. The results of the study are discussed. The study confirmed the association of the internal validity checklist with the effect size in trials of interventions for back pain.

A systematic review of measurement properties of health-status instruments is a tool for evaluating the quality of instruments. Our aim was to appraise the quality of the review process, to describe how authors assess the methodological quality of primary studies of measurement properties, and to describe how authors evaluate results of the studies. Literature searches were performed in three databases. One hundred and forty-eight reviews were included. The purpose of included reviews was to identify health status instruments used in an evaluative application and to report on the measurement properties of these instruments. Two independent reviewers selected the articles and extracted the data. Reviews were often of low quality: 22% of the reviews used one database, the search strategy was often poorly described, and in many cases it was not reported whether article selection (75%) and data extraction (71%) was done by two independent reviewers. In 11 reviews the methodological quality of the primary studies was evaluated for all measurement properties, and of these 11 reviews only 7 evaluated the results. Methods to evaluate the quality of the primary studies and the results differed widely. The poor quality of reviews hampers evidence-based selection of instruments. Guidelines for conducting and reporting systematic reviews of measurement properties should be developed. [ABSTRACT FROM AUTHOR]

Abstract: Background: Minor depression is common in primary care and associated with increased health care costs. Many mildly depressed patients are prescribed antidepressants, although there is insufficient information on the cost-effectiveness of antidepressants for these patients. The objective of this study was to evaluate whether usual care without antidepressants is equivalent to (i.e. as effective as and as expensive as) usual care with antidepressants in patients with minor or mild-major depression. Methods: Severity of depression was measured using the Montgomery Asberg Depression Rating Scale (MADRS) and quality-adjusted life-years (QALYs) using the EuroQol. Resource use was measured from a societal perspective using cost diaries. Bootstrapping was used to analyze the cost-effectiveness data. Results: Equivalence could not be shown for improvement in MADRS score or QALYs gained at 52 weeks. The mean (95% CI) difference in total costs between usual care without antidepressants and usual care with antidepressants was −€751 (−3601; 1522). Using an equivalence margin of €500 equivalence in costs could not be shown. In the cost-effectiveness analyses equivalence also could not be shown. Limitations: This study was underpowered for economic outcomes. Another limitation was the loss-to-follow-up. Conclusions: Although equivalence could not be shown in the costs and cost-effectiveness analyses, 95% confidence intervals also did not show that usual care without antidepressants was vastly superior or inferior to usual care with antidepressants. Therefore, we recommend general practitioners to show restraint when prescribing antidepressants to mildly depressed patients. [Copyright &y& Elsevier]