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Background
Disclosure of authors'' financial interests has been proposed as a strategy for protecting the integrity of the biomedical literature. We examined whether authors'' financial interests were disclosed consistently in articles on coronary stents published in 2006.Methodology/Principal Findings
We searched PubMed for English-language articles published in 2006 that provided evidence or guidance regarding the use of coronary artery stents. We recorded article characteristics, including information about authors'' financial disclosures. The main outcome measures were the prevalence, nature, and consistency of financial disclosures. There were 746 articles, 2985 authors, and 135 journals in the database. Eighty-three percent of the articles did not contain disclosure statements for any author (including declarations of no interests). Only 6% of authors had an article with a disclosure statement. In comparisons between articles by the same author, the types of disagreement were as follows: no disclosure statements vs declarations of no interests (64%); specific disclosures vs no disclosure statements (34%); and specific disclosures vs declarations of no interests (2%). Among the 75 authors who disclosed at least 1 relationship with an organization, there were 2 cases (3%) in which the organization was disclosed in every article the author wrote.Conclusions/Significance
In the rare instances when financial interests were disclosed, they were not disclosed consistently, suggesting that there are problems with transparency in an area of the literature that has important implications for patient care. Our findings suggest that the inconsistencies we observed are due to both the policies of journals and the behavior of some authors. 相似文献4.
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Background
The relationship between health professionals and the pharmaceutical industry has become a source of controversy. Physicians'' attitudes towards the industry can form early in their careers, but little is known about this key stage of development.Methods and Findings
We performed a systematic review reported according to PRISMA guidelines to determine the frequency and nature of medical students'' exposure to the drug industry, as well as students'' attitudes concerning pharmaceutical policy issues. We searched MEDLINE, EMBASE, Web of Science, and ERIC from the earliest available dates through May 2010, as well as bibliographies of selected studies. We sought original studies that reported quantitative or qualitative data about medical students'' exposure to pharmaceutical marketing, their attitudes about marketing practices, relationships with industry, and related pharmaceutical policy issues. Studies were separated, where possible, into those that addressed preclinical versus clinical training, and were quality rated using a standard methodology. Thirty-two studies met inclusion criteria. We found that 40%–100% of medical students reported interacting with the pharmaceutical industry. A substantial proportion of students (13%–69%) were reported as believing that gifts from industry influence prescribing. Eight studies reported a correlation between frequency of contact and favorable attitudes toward industry interactions. Students were more approving of gifts to physicians or medical students than to government officials. Certain attitudes appeared to change during medical school, though a time trend was not performed; for example, clinical students (53%–71%) were more likely than preclinical students (29%–62%) to report that promotional information helps educate about new drugs.Conclusions
Undergraduate medical education provides substantial contact with pharmaceutical marketing, and the extent of such contact is associated with positive attitudes about marketing and skepticism about negative implications of these interactions. These results support future research into the association between exposure and attitudes, as well as any modifiable factors that contribute to attitudinal changes during medical education. Please see later in the article for the Editors'' Summary 相似文献6.
Background
Adverse events are poor patient outcomes caused by medical care. Their identification requires the peer-review of poor outcomes, which may be unreliable. Combining physician ratings might improve the accuracy of adverse event classification.Objective
To evaluate the variation in peer-reviewer ratings of adverse outcomes; determine the impact of this variation on estimates of reviewer accuracy; and determine the number of reviewers who judge an adverse event occurred that is required to ensure that the true probability of an adverse event exceeded 50%, 75% or 95%.Methods
Thirty physicians rated 319 case reports giving details of poor patient outcomes following hospital discharge. They rated whether medical management caused the outcome using a six-point ordinal scale. We conducted latent class analyses to estimate the prevalence of adverse events as well as the sensitivity and specificity of each reviewer. We used this model and Bayesian calculations to determine the probability that an adverse event truly occurred to each patient as function of their number of positive ratings.Results
The overall median score on the 6-point ordinal scale was 3 (IQR 2,4) but the individual rater median score ranged from a minimum of 1 (in four reviewers) to a maximum median score of 5. The overall percentage of cases rated as an adverse event was 39.7% (3798/9570). The median kappa for all pair-wise combinations of the 30 reviewers was 0.26 (IQR 0.16, 0.42; Min = −0.07, Max = 0.62). Reviewer sensitivity and specificity for adverse event classification ranged from 0.06 to 0.93 and 0.50 to 0.98, respectively. The estimated prevalence of adverse events using a latent class model with a common sensitivity and specificity for all reviewers (0.64 and 0.83 respectively) was 47.6%. For patients to have a 95% chance of truly having an adverse event, at least 3 of 3 reviewers are required to deem the outcome an adverse event.Conclusion
Adverse event classification is unreliable. To be certain that a case truly represents an adverse event, there needs to be agreement among multiple reviewers. 相似文献7.
Background
There is an emerging literature on the existence and effect of industry relationships on physician and researcher behavior. Much less is known, however, about the effects of these relationships and other conflicts of interest (COI) on clinical practice guideline (CPG) development and recommendations. We performed a systematic review of the prevalence of COI and its effect on CPG recommendations.Methodology/Principal Findings
We searched Medline (1980 to March, 2011) for studies that examined the effect of COI on CPG development and/or recommendations. Data synthesis was qualitative. Twelve studies fulfilled inclusion criteria; 9 were conducted in the US. All studies reported on financial relationships of CPG authors with the pharmaceutical industry; 1 study also examined relationships with diagnostic testing and insurance companies. The majority of guidelines had authors with industry affiliations, including consultancies (authors with relationship, range 6–80%); research support (4–78%); equity/stock ownership (2–17%); or any COI (56–87%). Four studies reported multiple types of financial interactions for individual authors (number of types per author: range 2 to 10 or more). Data on the effect of COI on CPG recommendations were confined to case studies wherein authors with specific financial ties appeared to benefit from the related CPG recommendations. In a single study, few authors believed that their relationships influenced their recommendations. No studies reported on intellectual COI in CPGs.Conclusions/Significance
There are limited data describing the high prevalence of COI among CPG authors, and only case studies of the effect of COI on CPG recommendations. Further research is needed to explore this potential source of bias. 相似文献8.
Background
The Risk of Bias (RoB) tool is used to assess internal validity of randomized controlled trials (RCTs). Our objectives were to: 1) evaluate inter-rater agreement of the RoB tool; 2) determine the time to access supplemental study information; 3) compare the RoB tool with the Jadad scale and Schulz allocation concealment (AC); and 4) examine the relationship between RoB and effect estimates.Methods
We conducted a systematic review of long-acting beta agonists (LABA) combined with inhaled corticosteroids (ICS) for adults with persistent asthma. Two reviewers independently assessed 107 trials using RoB, Jadad, and AC. One reviewer searched for study protocols. We assessed inter-rater agreement using weighted Kappa (κ) and the correlation between tools using Kendall''s Tau (τ). Mean differences in effect sizes for RCTs with different RoB were calculated using inverse variance method and random effects model.Results
Trials had good Jadad scores (median 4, IQR 3-4); however, 85% had unclear AC and 87% high RoB. The factor that most influenced RoB was the potential inappropriate influence of study sponsors (95% industry funded). Agreement on RoB domains was fair (κ = 0.40) to almost perfect (κ = 0.86), and moderate for overall RoB (κ = 0.41). Median time to complete RoB assessments was 21 minutes (IQR 14-27) and 12 minutes (IQR 9-16) to search for protocols. Protocols were identified for 5/42 studies (12%); in 3 cases the assessment of selective outcome reporting changed. There was low correlation between overall RoB vs. Jadad (τ = 0.04, p = 0.3) and AC (τ = −0.02, p = 0.7). Analyses comparing effect estimates and risk showed no important patterns.Conclusions
Inter-rater agreement on RoB assessments was better than previously reported suggesting that review-specific guidelines are important. The correlation between RoB and Jadad was low suggesting measurement of different constructs (risk of bias vs. quality of reporting). The extensive involvement of the pharmaceutical industry in this LABA/ICS research should raise concerns about potential overestimates of treatment effects. 相似文献9.
Background
Use of a risk of bias (ROB) tool has been encouraged and advocated to reviewers writing systematic reviews (SRs) and meta-analyses (MAs). Selective outcome reporting and other sources of bias are included in the Cochrane ROB tool. It is important to know how this specific tool for assessing ROB has been applied since its release. Our objectives were to evaluate whether and to what extent the new Cochrane ROB tool has been used in Chinese journal papers of acupuncture.Methods
We searched CBM, TCM database, CJFD, CSJD, and the Wanfang Database from inception to March 2011. Two reviewers independently selected SRs that primarily focused on acupuncture and moxibustion, from which the data was extracted and analyzed.Results
A total of 836 SRs were identified from the search, of which, 105 were included and four are awaiting assessment. Thirty-six of the 105 SRs were published before release of the Cochrane ROB tool (up to 2009). Most used the Cochrane Handbook 4.2 or Jadad''s scale for risk or quality assessment. From 2009 to March 2011 69 SRs were identified. While “risk of bias” was reported for approximately two-thirds of SRs, only two SRs mentioned use of a “risk of bias tool” in their assessment. Only 5.8% (4/69) of reviews reported information on all six domains which are involved in the ROB tool. A risk of bias graph/summary figure was provided in 2.9% (2/69) of reviews. Most SRs gave information about sequence generation, allocation concealment, blindness, and incomplete outcome data, however, few reviews (5.8%; 4/69) described selective reporting or other potential sources of bias.Conclusions
The Cochrane “risk of bias” tool has not been used in all SRs/MAs of acupuncture published in Chinese Journals after 2008. When the ROB tool was used, reporting of relevant information was often incomplete. 相似文献10.
Background and Objectives
This paper focuses on the inadequate attention on women''s non-maternal healthcare in low- and middle-income countries. The study assessed the purchase of and financial access to non-maternal healthcare. It also scoped for mainstreaming household financial resources in this regard to suggest for alternatives.Methods
A household survey through multi-stage stratified sampling in the state of Orissa interviewed rural women above 15 years who were neither pregnant nor had any pregnancy-related outcome six weeks preceding the survey. The questions explored on the processes, determinants and outcomes of health seeking for non-maternal ailments. The outcome measures were healthcare access, cost of care and financial access. The independent variables for bivariate and multivariate analyses were contextual factors, health seeking and financing pattern.Results
The survey obtained a response rate of 98.64% and among 800 women, 43.8% had no schooling and 51% were above 60 years. Each woman reported at least one episode of non-maternal ailment; financial constraints prevented 68% from receiving timely and complete care. Distress coping measures (e.g. borrowings) dominated the financing source (67.9%) followed by community–based measures (32.1%). Only 6% had financial risk-protection; financial risk of not obtaining care doubled for women aged over 60 years (OR 2.00, 95% CI 0.84–4.80), seeking outpatient consultation (OR 2.01, 95% CI 0.89–4.81), facing unfavourable household response (OR 2.04, 95% CI 1.09–3.83), and lacking other financial alternatives (OR 2.13, 95% CI 1.11–4.07). When it comes to timely mobilization of funds and healthcare seeking, 90% (714) of the households preferred maternal care to non-maternal healthcare.Conclusion
The existing financing options enable sub-optimal purchase of women''s non-maternal healthcare. Though dominant, household economy extends inadequate attention in this regard owing to its unfavourable approach towards non-maternal healthcare and limited financial capacity and support from other financial resources. 相似文献11.
Background
The source of funding is one of many possible causes of bias in scientific research. One method of detecting potential for bias is to evaluate the quality of research reports. Research exploring the relationship between funding source and nutrition-related research report quality is limited and in other disciplines the findings are mixed.Objective
The purpose of this study is to determine whether types of funding sources of nutrition research are associated with differences in research report quality.Design
A retrospective study of research reporting quality, research design and funding source was conducted on 2539 peer reviewed research articles from the American Dietetic Association''s Evidence Analysis Library® database.Results
Quality rating frequency distributions indicate 43.3% of research reports were rated as positive, 50.1% neutral, and 6.6% as negative. Multinomial logistic regression results showed that while both funding source and type of research design are significant predictors of quality ratings (χ2 = 118.99, p<0.001), the model''s usefulness in predicting overall research report quality is little better than chance. Compared to research reports with government funding, those not acknowledging any funding sources, followed by studies with University/hospital funding were more likely to receive neutral vs positive quality ratings, OR = 1.85, P <0.001 and OR = 1.54, P<0.001, respectively and those that did not report funding were more likely to receive negative quality ratings (OR = 4.97, P<0.001). After controlling for research design, industry funded research reports were no more likely to receive a neutral or negative quality rating than those funded by government sources.Conclusion
Research report quality cannot be accurately predicted from the funding source after controlling for research design. Continued vigilance to evaluate the quality of all research regardless of the funding source and to further understand other factors that affect quality ratings are warranted. 相似文献12.
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All the opinions in this article are those of the authors and should not be construed to reflect, in any way, those of the Department of Veterans Affairs.
Background
Our study purpose was to assess the predictive validity of reviewer quality ratings and editorial decisions in a general medicine journal.Methods
Submissions to the Journal of General Internal Medicine (JGIM) between July 2004 and June 2005 were included. We abstracted JGIM peer review quality ratings, verified the publication status of all articles and calculated an impact factor for published articles (Rw) by dividing the 3-year citation rate by the average for this group of papers; an Rw>1 indicates a greater than average impact.Results
Of 507 submissions, 128 (25%) were published in JGIM, 331 rejected (128 with review) and 48 were either not resubmitted after revision was requested or were withdrawn by the author. Of 331 rejections, 243 were published elsewhere. Articles published in JGIM had a higher citation rate than those published elsewhere (Rw: 1.6 vs. 1.1, p = 0.002). Reviewer quality ratings of article quality had good internal consistency and reviewer recommendations markedly influenced publication decisions. There was no quality rating cutpoint that accurately distinguished high from low impact articles. There was a stepwise increase in Rw for articles rejected without review, rejected after review or accepted by JGIM (Rw 0.60 vs. 0.87 vs. 1.56, p<0.0005). However, there was low agreement between reviewers for quality ratings and publication recommendations. The editorial publication decision accurately discriminated high and low impact articles in 68% of submissions. We found evidence of better accuracy with a greater number of reviewers.Conclusions
The peer review process largely succeeds in selecting high impact articles and dispatching lower impact ones, but the process is far from perfect. While the inter-rater reliability between individual reviewers is low, the accuracy of sorting is improved with a greater number of reviewers. 相似文献14.
Background
Medical studies are more likely to report favorable findings when a conflict of interest is declared. We aim to quantify and determine the effect of author disclosure of conflict of interest on scientific reporting.Methods
Abstracts from an international spine research meeting (North American Spine Society 2010) were selected that specifically evaluated a device, biologic, or proprietary procedure. They were then made anonymous to reviewers. An item of interest was established in each of the abstracts in order to standardize evaluation. Next, three blinded reviewers independently rated the abstracts as favorable, neutral, or unfavorable with regard to the item of interest. Additionally, the blinded reviewers attempted to predict whether a related disclosure was made. The meeting disclosure index was used to tabulate the minimum US dollar value attributable to disclosures.Results
Of the 344 total abstracts, 76 met inclusion criteria. In 79%, a related conflict of interest was reported. The amount of the disclosure was incompletely reported in 30% of cases. Where available, it averaged a cumulative minimum of $219,634 USD per abstract. The results of the abstracts were judged to be favorable, neutral, and unfavorable in 63%, 32% and 5% of abstracts, respectively. There was no correlation between the presence of a related disclosure and the findings of the studies (p = 0.81), although interpretation of this is limited by a small sample size and an overall apparent bias to report favorable studies. Additionally, the blinded reviewers were unable to predict whether a related disclosure was made (p = 0.40).Conclusion
No association existed between the presence of a related disclosure and the results of the studies. While the actual compliance with reporting a potential conflict of interest is unable to be determined, the value amount related to the disclosures made was inadequately reported according to meeting guidelines. 相似文献15.
Objectives
As more families participate expanded newborn screening for metabolic disorders in China, the overall number of false positives increases. Our goal was to assess the potential impact on parental stress, perceptions of the child''s health, and family relationships.Methods
Parents of 49 infants with false-positive screening results for metabolic disorders in the expanded newborn screening panel were compared with parents of 42 children with normal screening results. Parents first completed structured interview using likert scales, closed and open questions. Parents also completed the parenting stress index.Results
A total of 88 mothers and 41 fathers were interviewed. More mothers in the false-positive group reported that their children required extra parental care (21%), compared with 5% of mothers in the normal-screened group (P<0.001). 39% of mothers in the false-positive group reported that they worry about their child''s future development, compared with 10% of mothers in the normal-screened group (P<0.001). Fathers in the false-positive group did not differ from fathers in the normal-screened group in reporting worry about their child''s extra care requirements, and their child''s future development. Children with false-positive results compared with children with normal results were triple as likely to experience hospitalization (27%vs 9%, respectively; P<0.001).Conclusions
The results showing false-positive screening results may affect parental stress and the parent-child relationship. Parental stress and anxiety can be reduced with improved education and communication to parents about false-positive results. 相似文献16.
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Background
Lack of transparency in clinical trial conduct, publication bias and selective reporting bias are still important problems in medical research. Through clinical trials registration, it should be possible to take steps towards resolving some of these problems. However, previous evaluations of registered records of clinical trials have shown that registered information is often incomplete and non-meaningful. If these studies are accurate, this negates the possible benefits of registration of clinical trials.Methods and Findings
A 5% sample of records of clinical trials that were registered between 17 June 2008 and 17 June 2009 was taken from the International Clinical Trials Registry Platform (ICTRP) database and assessed for the presence of contact information, the presence of intervention specifics in drug trials and the quality of primary and secondary outcome reporting. 731 records were included. More than half of the records were registered after recruitment of the first participant. The name of a contact person was available in 94.4% of records from non-industry funded trials and 53.7% of records from industry funded trials. Either an email address or a phone number was present in 76.5% of non-industry funded trial records and in 56.5% of industry funded trial records. Although a drug name or company serial number was almost always provided, other drug intervention specifics were often omitted from registration. Of 3643 reported outcomes, 34.9% were specific measures with a meaningful time frame.Conclusions
Clinical trials registration has the potential to contribute substantially to improving clinical trial transparency and reducing publication bias and selective reporting. These potential benefits are currently undermined by deficiencies in the provision of information in key areas of registered records. 相似文献19.
Trends in breast cancer mortality in Sweden before and after implementation of mammography screening
Background
Incidence-based mortality modelling comparing the risk of breast cancer death in screened and unscreened women in nine Swedish counties has suggested a 39% risk reduction in women 40 to 69 years old after introduction of mammography screening in the 1980s and 1990s.Objective
We evaluated changes in breast cancer mortality in the same nine Swedish counties using a model approach based on official Swedish breast cancer mortality statistics, robust to effects of over-diagnosis and treatment changes. Using mortality data from the NordCan database from 1974 until 2003, we estimated the change in breast cancer mortality before and after introduction of mammography screening in at least the 13 years that followed screening start.Results
Breast mortality decreased by 16% (95% CI: 9 to 22%) in women 40 to 69, and by 11% (95% CI: 2 to 20%) in women 40 to 79 years of age.Discussion
Without individual data it is impossible to completely separate the effects of improved treatment and health service organisation from that of screening, which would bias our results in favour of screening. There will also be some contamination of post-screening mortality from breast cancer diagnosed prior to screening, beyond our attempts to adjust for delayed benefit. This would bias against screening. However, our estimates from publicly available data suggest considerably lower benefits than estimates based on comparison of screened versus non-screened women. 相似文献20.