Journal of Clinical Apheresis 00:00–00 (2015)
Apheresis Research–More Abstracts Should Be Published as Full Manuscripts to Provide More Evidence for Clinical Practice Guidelines Huy P. Pham,1* Ning Jiang,2 Zhi Pan,3 Lance A. Williams III,1 and Marisa B. Marques1 1
Department of Pathology, University of Alabama at Birmingham, Birmingham, Alabama 2 Center for Family Life at Sunset Park, SCO Family of Services, Brooklyn, New York 3 Center for Public Health Initiatives, University of Pennsylvania, Philadelphia, Pennsylvania High-quality evidence to support clinical practice is lacking in apheresis medicine compared to other therapeutic modalities. A potential source of evidence comes from the abstracts submitted to the Annual Meetings of the American Society for Apheresis (ASFA). Therefore, the goal of this study is to determine the proportion of abstracts from the 2005 to 2012 ASFA Annual Meetings that subsequently became PubMed-indexed publications. Furthermore, we sought to determine the factor(s) that were associated with the likelihood of abstracts to be published as full manuscripts. During the 8-year study period, 684 abstracts were available for analysis (median: 82/year, range: 64–118). Most abstracts (74%) were from US institutions, and 67% of first authors were affiliated with academic centers. There were more abstracts (64%) on therapeutic versus donor apheresis (20%) and cellular therapy (16%). Overall, 16% of the abstracts have been published in PubMed-indexed journals, with a median time of 17 months from the ASFA Annual Meeting (range: 1–96 months). Abstracts whose first authors were affiliated with academic institutions were 3.14 times more likely to have been published than abstracts with ones affiliated with an apheresis organization and/or a community hospital. However, neither the first author’s location nor the type of apheresis procedure significantly affected the publication rate after adjusting for other covariates. In conclusion, the rate of publication is low and authors should be encouraged to follow their presentations at the meeting with peer-reviewed manuscripts. This change is essential to provide more pubC 2015 Wiley Perilished evidence for future apheresis practice guidelines. J. Clin. Apheresis 00:000–000, 2015. V odicals, Inc.
Key words: abstracts; apheresis; evidence-based; manuscripts; publications
INTRODUCTION
Apheresis procedures are used for both donor and therapeutic purposes. Since there is a wide spectrum of diseases treated by apheresis, multiple medical specialties care for apheresis patients in a variety of care settings. We suggest that this practice has led to fragmentation of the published data from apheresis research, resulting in scarce high-quality evidence on the mechanism, relevance, appropriateness, efficacy, and comparative value of apheresis versus other treatment modalities [1–3]. A recent PubMed search with the keyword “apheresis” yielded a median of 578 indexed articles per year (range: 554–728) in English language between 2005 and 2012. Another literature search using “therapeutic apheresis” only, “donor apheresis” only, and “cellular therapy” only was also performed and the results showed a yearly median of 17 (range: 6–26), 6 (range: 3–9), and 168 (range: 68– 274) articles in each field, respectively during the same time-period. Hence, in 2012, the National Heart, Lung, and Blood Institute (NHLBI) in collaboration with the American Society for Apheresis (ASFA) held a sympoC 2015 Wiley Periodicals, Inc. V
sium to address the need for apheresis research, as well as the barriers to achieving that goal [3–6]. They concluded that there is a need to establish consortia in apheresis to facilitate research, networking, and collaboration among researchers, especially junior investigators, as well as to promote funding for apheresis research [3]. The premier source of therapeutic apheresis information is the ASFA Guidelines, published every 3 years in the Journal of Clinical Apheresis (JCA), the official ASFA journal. Since the guidelines’ goal is to provide evidence-based information, they depend on Conflicts of interest: The authors declare that they have no conflict of interest relevant to this manuscript. *Correspondence to: Huy P. Pham, MD, MPH, University of Alabama at Birmingham, Department of Pathology, Division of Laboratory Medicine, 619 19th Street S, WP-P230E, Birmingham, AL 35249, USA. E-mail: [email protected]. Received 29 December 2014; Accepted 29 April 2015 Published online 00 Month 2015 in Wiley Online Library (wileyonlinelibrary.com). DOI: 10.1002/jca.21405
2
Pham et al.
published manuscripts and peer-reviewed research. First published in 1986, there have been 5 updates to the guidelines, the most recent in 2013 [1,7–9]. However, the guidelines are limited by the amount of published evidence to support (or to refute) the use of apheresis in particular diseases or conditions [9]. Currently, the quality of the evidence used by the experts to make recommendations for the ASFA Guidelines is derived mostly from case reports and case series [10]. In fact, in a recent search for therapeutic apheresis publications using the MEDLINE database between January 1, 2000 and February 9, 2012, only 53 of 7,841 articles were randomized clinical trials [2]. Additionally, not all diagnoses for which therapeutic apheresis has been used or all the potential ones for which it might be effective are included in the guidelines for lack of evidence [9]. For instance, the use of therapeutic plasma exchange and red blood cell exchange in the treatment of erythropoietic protoporphyria might be beneficial; however, there was not enough evidence to include this condition in any of the previous ASFA Guidelines [1,9,11,12]. Thus, many patients could benefit from publications with new evidence clarifying the role of apheresis and several new diagnoses could qualify for inclusion in subsequent editions of the ASFA Guidelines. The ASFA Annual Meeting is a forum where new research is discussed as oral presentations or posters which were submitted as abstracts by the authors. While the conference abstracts are published in JCA, they are not PubMed-indexed. Thus, the information is not widely available, except to the meeting’s attendees or JCA readers. Furthermore, the depth and level of detail in a published manuscript are significantly greater and more useful than those in an abstract. Because both ASFA and NHLBI discussed the need for more evidence to support the indications, efficacy, and cost-effectiveness of apheresis therapies compared to other treatment modalities, we conducted a review of all abstracts presented at the ASFA Annual Meetings from 2005 to 2012. We determined the rate of abstracts becoming PubMed-indexed manuscripts and the factor(s) associated with a successful publication. METHODS Study Design
All abstracts accepted to the ASFA Annual Meeting during the 8-year period from 2005 to 2012 were reviewed [13–20]. A PubMed search using the authors’ names and/or abstract title was conducted for each abstract to determine if it was published in a PubMedindexed journal in English language by the end of September 2014. The length of time from the publication of the abstract in JCA to the publication of the full manuscript, either as E-pub or in printed form (whichJournal of Clinical Apheresis DOI 10.1002/jca
ever occurred earlier), was also calculated. In the event that a manuscript with similar data as the abstract was published prior to the publication of the abstract in JCA (by the same authors or his/her group), the abstract was excluded from the analysis. Additionally, each abstract was categorized based on the first author’s location (US vs. non-US), first author’s institution (academic center, which was defined as any medical school and/or its major teaching hospital vs. blood center vs. others), and apheresis type (donor apheresis vs. therapeutic apheresis vs. cellular therapy). The primary outcome of the study was the rate of abstracts becoming manuscripts in PubMed-indexed journals. Secondary outcomes included the association between first author’s location, institution type, and apheresis modality to predict publication. Statistical Analysis
All statistical analyses were performed using SAS version 9.4 (SAS Institute, Cary, NC). Chi-square testing was used to compare the number of abstracts submitted from different countries, institutions, and apheresis type across the 8-year study period. Univariate analysis was performed using log-rank test to assess the relationship between each individual factor, such as location, institution, and apheresis type, and the primary outcome, as described above. Finally, a Cox proportional hazard model was built to determine the effect of all the covariates on the primary outcome. A P-value of
Apheresis Research–More Abstracts Should Be Published as Full Manuscripts to Provide More Evidence for Clinical Practice Guidelines Huy P. Pham,1* Ning Jiang,2 Zhi Pan,3 Lance A. Williams III,1 and Marisa B. Marques1 1
Department of Pathology, University of Alabama at Birmingham, Birmingham, Alabama 2 Center for Family Life at Sunset Park, SCO Family of Services, Brooklyn, New York 3 Center for Public Health Initiatives, University of Pennsylvania, Philadelphia, Pennsylvania High-quality evidence to support clinical practice is lacking in apheresis medicine compared to other therapeutic modalities. A potential source of evidence comes from the abstracts submitted to the Annual Meetings of the American Society for Apheresis (ASFA). Therefore, the goal of this study is to determine the proportion of abstracts from the 2005 to 2012 ASFA Annual Meetings that subsequently became PubMed-indexed publications. Furthermore, we sought to determine the factor(s) that were associated with the likelihood of abstracts to be published as full manuscripts. During the 8-year study period, 684 abstracts were available for analysis (median: 82/year, range: 64–118). Most abstracts (74%) were from US institutions, and 67% of first authors were affiliated with academic centers. There were more abstracts (64%) on therapeutic versus donor apheresis (20%) and cellular therapy (16%). Overall, 16% of the abstracts have been published in PubMed-indexed journals, with a median time of 17 months from the ASFA Annual Meeting (range: 1–96 months). Abstracts whose first authors were affiliated with academic institutions were 3.14 times more likely to have been published than abstracts with ones affiliated with an apheresis organization and/or a community hospital. However, neither the first author’s location nor the type of apheresis procedure significantly affected the publication rate after adjusting for other covariates. In conclusion, the rate of publication is low and authors should be encouraged to follow their presentations at the meeting with peer-reviewed manuscripts. This change is essential to provide more pubC 2015 Wiley Perilished evidence for future apheresis practice guidelines. J. Clin. Apheresis 00:000–000, 2015. V odicals, Inc.
Key words: abstracts; apheresis; evidence-based; manuscripts; publications
INTRODUCTION
Apheresis procedures are used for both donor and therapeutic purposes. Since there is a wide spectrum of diseases treated by apheresis, multiple medical specialties care for apheresis patients in a variety of care settings. We suggest that this practice has led to fragmentation of the published data from apheresis research, resulting in scarce high-quality evidence on the mechanism, relevance, appropriateness, efficacy, and comparative value of apheresis versus other treatment modalities [1–3]. A recent PubMed search with the keyword “apheresis” yielded a median of 578 indexed articles per year (range: 554–728) in English language between 2005 and 2012. Another literature search using “therapeutic apheresis” only, “donor apheresis” only, and “cellular therapy” only was also performed and the results showed a yearly median of 17 (range: 6–26), 6 (range: 3–9), and 168 (range: 68– 274) articles in each field, respectively during the same time-period. Hence, in 2012, the National Heart, Lung, and Blood Institute (NHLBI) in collaboration with the American Society for Apheresis (ASFA) held a sympoC 2015 Wiley Periodicals, Inc. V
sium to address the need for apheresis research, as well as the barriers to achieving that goal [3–6]. They concluded that there is a need to establish consortia in apheresis to facilitate research, networking, and collaboration among researchers, especially junior investigators, as well as to promote funding for apheresis research [3]. The premier source of therapeutic apheresis information is the ASFA Guidelines, published every 3 years in the Journal of Clinical Apheresis (JCA), the official ASFA journal. Since the guidelines’ goal is to provide evidence-based information, they depend on Conflicts of interest: The authors declare that they have no conflict of interest relevant to this manuscript. *Correspondence to: Huy P. Pham, MD, MPH, University of Alabama at Birmingham, Department of Pathology, Division of Laboratory Medicine, 619 19th Street S, WP-P230E, Birmingham, AL 35249, USA. E-mail: [email protected]. Received 29 December 2014; Accepted 29 April 2015 Published online 00 Month 2015 in Wiley Online Library (wileyonlinelibrary.com). DOI: 10.1002/jca.21405
2
Pham et al.
published manuscripts and peer-reviewed research. First published in 1986, there have been 5 updates to the guidelines, the most recent in 2013 [1,7–9]. However, the guidelines are limited by the amount of published evidence to support (or to refute) the use of apheresis in particular diseases or conditions [9]. Currently, the quality of the evidence used by the experts to make recommendations for the ASFA Guidelines is derived mostly from case reports and case series [10]. In fact, in a recent search for therapeutic apheresis publications using the MEDLINE database between January 1, 2000 and February 9, 2012, only 53 of 7,841 articles were randomized clinical trials [2]. Additionally, not all diagnoses for which therapeutic apheresis has been used or all the potential ones for which it might be effective are included in the guidelines for lack of evidence [9]. For instance, the use of therapeutic plasma exchange and red blood cell exchange in the treatment of erythropoietic protoporphyria might be beneficial; however, there was not enough evidence to include this condition in any of the previous ASFA Guidelines [1,9,11,12]. Thus, many patients could benefit from publications with new evidence clarifying the role of apheresis and several new diagnoses could qualify for inclusion in subsequent editions of the ASFA Guidelines. The ASFA Annual Meeting is a forum where new research is discussed as oral presentations or posters which were submitted as abstracts by the authors. While the conference abstracts are published in JCA, they are not PubMed-indexed. Thus, the information is not widely available, except to the meeting’s attendees or JCA readers. Furthermore, the depth and level of detail in a published manuscript are significantly greater and more useful than those in an abstract. Because both ASFA and NHLBI discussed the need for more evidence to support the indications, efficacy, and cost-effectiveness of apheresis therapies compared to other treatment modalities, we conducted a review of all abstracts presented at the ASFA Annual Meetings from 2005 to 2012. We determined the rate of abstracts becoming PubMed-indexed manuscripts and the factor(s) associated with a successful publication. METHODS Study Design
All abstracts accepted to the ASFA Annual Meeting during the 8-year period from 2005 to 2012 were reviewed [13–20]. A PubMed search using the authors’ names and/or abstract title was conducted for each abstract to determine if it was published in a PubMedindexed journal in English language by the end of September 2014. The length of time from the publication of the abstract in JCA to the publication of the full manuscript, either as E-pub or in printed form (whichJournal of Clinical Apheresis DOI 10.1002/jca
ever occurred earlier), was also calculated. In the event that a manuscript with similar data as the abstract was published prior to the publication of the abstract in JCA (by the same authors or his/her group), the abstract was excluded from the analysis. Additionally, each abstract was categorized based on the first author’s location (US vs. non-US), first author’s institution (academic center, which was defined as any medical school and/or its major teaching hospital vs. blood center vs. others), and apheresis type (donor apheresis vs. therapeutic apheresis vs. cellular therapy). The primary outcome of the study was the rate of abstracts becoming manuscripts in PubMed-indexed journals. Secondary outcomes included the association between first author’s location, institution type, and apheresis modality to predict publication. Statistical Analysis
All statistical analyses were performed using SAS version 9.4 (SAS Institute, Cary, NC). Chi-square testing was used to compare the number of abstracts submitted from different countries, institutions, and apheresis type across the 8-year study period. Univariate analysis was performed using log-rank test to assess the relationship between each individual factor, such as location, institution, and apheresis type, and the primary outcome, as described above. Finally, a Cox proportional hazard model was built to determine the effect of all the covariates on the primary outcome. A P-value of
