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Journal of Evaluation in Clinical Practice ISSN 1365-2753
Does the CONSORT checklist for abstracts improve the quality of reports of randomized controlled trials on clinical pathways? Qi Cui MM,1,2 Jinhui Tian MD,2 Xuping Song MM2 and Kehu Yang MM3 1 2
Research Fellow, The First Hospital of Lanzhou University, Lanzhou University, Lanzhou, China Research Fellow, 3Professor, Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou, China
Keywords abstracts, clinical pathway, randomized controlled trial, research design Correspondence Prof Kehu Yang Evidence-Based Medicine Center, School of Basic Medical Sciences Lanzhou University No.199, Donggang West Road, Chengguan District Lanzhou, Gansu 730000 China E-mail: [email protected] Accepted for publication: 14 May 2014 doi:10.1111/jep.12200
Abstract Rationale, aims and objectives The extension of the Consolidated Standards of Reporting Trials (CONSORT) statement provides reporting guidelines to improve the reporting quality of randomized controlled trials (RCTs). This present study was aim to assess the reporting quality of abstracts of RCTs on clinical pathway. Methods Eight databases were searched from inception to November 2012 to identify RCTs. We extracted basic information and CONSORT items from abstracts. Each abstract was assessed independently by two reviewers. Statistical analyses were performed with SPSS 13.0. Level of significance was set at P < 0.05. Results 328 abstracts were included. 300 (91.5%) were published in Chinese, of which 292 were published on high impact factor journals. 28 English abstracts were all published on Science Citation Index (SCI) journals. (1) Intervention, objective and outcome were almost fully reported in all abstracts, while recruitment and funding were never reported. (2) There are nine items (P < 0.05) in Chinese that were of low quality compared with in English. There was statistically difference on total score between Chinese and English abstracts (P < 0.00001). (3) There was no difference in any items between high and low impact factor journal in China. (4) In SCI journals, there were significant changes in reporting for three items trial design (P = 0.026), harms (P = 0.039) and trial registration (P = 0.019) in different periods (pre- and post-CONSORT), but only the numbers of randomized (P = 0.003) changed in Chinese abstracts. Conclusions The reporting quality of abstracts of RCTs on clinical pathway still should be improved. After the publication of CONSORT for abstracts guideline, the RCT abstracts reporting quality were improvement to some extent. The abstracts in Chinese journals showed non-adherence to the CONSORT for abstracts guidelines.
Introduction Randomized controlled trials (RCTs) are considered the highest grade of evidence in the hierarchy of research designs [1]. The RCT, more than any other methodology, can have a powerful and immediate impact on patient care. For RCTs to ultimately benefit patients, the published report should meet the highest possible standards [2]. In some geographic areas, an RCT abstract may be the only portion of the article to which health professionals have easy access, and health care decisions may be made solely according to the information in the abstract [3]. Clear, transparent and sufficiently detailed abstracts for clinical trials are important because readers often base their assessment of a trial on such information [4].
The Consolidated Standards for Reporting Trials (CONSORT) for abstracts aim to improve abstract reporting of RCTs published in journal articles and conference proceedings. CONSORT helps RCT abstract authors provide the detail and clarity needed by readers wishing to assess a trial’s validity and the applicability of its results [3]. The number of systematic reviews about clinical pathways is increasing. Failure to describe the methodology accurately in abstracts might cause the research to be overlooked by readers during casual scanning. Such failure could also complicate study identification during retrieval for meta-analysis, with significant potential effects on health care delivery [5]. The aim of our study was to investigate the reporting quality of abstracts of RCTs on clinical pathways and to examine if there was any improvement in reporting after the CONSORT for abstracts
Journal of Evaluation in Clinical Practice 20 (2014) 827–833 © 2014 John Wiley & Sons, Ltd.
827
Quality of RCTs on clinical pathway
was published. We also aim to identify the differences between the reporting quality of high and low impact factor journals in China and Science Citation Index (SCI) journals.
Methods Selection of RCTs PubMed (1966–2012.11), the Cochrane Library (Issue 11, 2012), EMBASE (1974–2012.11), Web of Science (1974–2012.11), the China Journal Full-text Database (1994–2012.11), Chinese Scientific Journals Full-text Database (1989–2012.11), Chinese Biomedical Literature Database (1978–2012.11) and the WANFANG Database (1980–2012.11) were searched. The following search strategy and keywords were used to access the records: Critical pathways [Mesh] or clinical pathway [Title/Abstracts] or clinical pathways [Title/Abstracts] or clinical path [Title/Abstracts] or clinical paths [Title/Abstracts] or critical pathway [Title/ Abstracts] or critical pathways [Title/Abstracts] or critical path [Title/Abstracts] or critical paths [Title/Abstracts] or care pathway [Title/Abstracts] or care pathways [Title/Abstracts] or care path [Title/Abstracts] or care paths [Title/Abstracts] or care map [Title/Abstracts] or care maps [Title/Abstracts] or care protocol [Title/Abstracts] or care protocols [Title/Abstracts] and random* [All fields]. The inclusion criteria were as follows. RCT abstracts of interventions found using the keywords above were selected. We included abstracts in which the investigators described a random component in the sequence generation process. These descriptions included referring to a random number table; using a computer random number generator; coin tossing; shuffling cards or envelopes; throwing dice; or drawing of lots as defined by the Cochrane Handbook. We also included abstracts in which the allocation of participants to interventions was described by the words ‘random’, ‘randomly allocated’, ‘randomized’ or ‘randomization’ [6]. Only structured abstracts were included. Each study was assessed independently by two reviewers. Study eligibility was identified by screening titles, abstracts, or the full text. When there were differences, consensus was reached through discussion and confirmed by the third researcher.
Data extraction Two well-trained reviewers extracted data and assessed the abstracts according to the CONSORT for abstracts. A consensus process was used to resolve disagreements. For each included abstract, we extracted data on the items recommend by the extension of the CONSORT for abstracts [3]. Ratings of ‘adequate’, ‘inadequate’ and ‘no description’ – indicating level of detail the author reported – were assigned for each item. The score for each item ranged from 0 to 1 [7]. Zero represented no description of the item, 0.5 represented inadequate description and 1 represented adequate description. Additionally, descriptive information such as journal name, publication year and country; number of authors; number of author affiliations; sample sizes; and involved diseases were recorded. See Appendix A for a table summarizing the data extracted. 828
Q. Cui et al.
Data analysis We classified abstracts according to the citation and the year that the CONSORT extension was published (pre-CONSORT before 2009, post-CONSORT during or after 2009). Citations were classified as high impact factor journals in China, low impact factor journals in China and SCI citations. We classified journals as high impact factor if they were included in the Chinese Science Citation Database (CSCD). The diseases to which clinical pathways referred were grouped by the International Classification of Diseases (ICD-10). Proportions of reported items in two groups were compared using independent sample Student’s t-test. Data for descriptive statistics were performed using Microsoft Excel 2007 and SPSS (version 13.0; SPSS, Inc., Chicago, IL, USA). Level of significance was set at P < 0.05.
Results Our electronic search strategy initially identified 8813 records. Of these, 7603 non-RCT abstracts and 882 non-clinical pathway abstracts were excluded, as presented in Fig. 1. A total of 328 RCT abstracts about clinical pathways were included for the analysis.
Study characteristics As reported in Table 1, 300 (91.5%) RCTs were published in Chinese and 28 (8.5%) in other languages. Eight (2.4%) were cited in high impact factor journals in China and 28 (8.5%) were cited in SCI. The majority of RCTs focused on diseases of the circulatory system (18.6%), followed by diseases of the digestive system (13.7%), neoplasms (11.3%), the genitourinary system (10.4%)
Initial search in database (n = 8813)
7603 non-RCT abstracts excluded
1210 potentially eligible evaluations
882 non-clinical pathway abstracts excluded 328 RCT abstracts on clinical pathway included Figure 1 Flow chart of the literature search and identification of abstracts for assessment of the quality of reporting.
© 2014 John Wiley & Sons, Ltd.
Q. Cui et al.
Quality of RCTs on clinical pathway
Table 1 Characteristics of the included trial abstracts Abstract characteristic (n = 328 abstracts) Language Chinese English Journal CSCD Non-CSCD SCI Classification of diseases Diseases of the circulatory system Diseases of the digestive system Neoplasms Diseases of the genitourinary system Diseases of the respiratory system Publication year 1999 2000 2002 2003 2005 2004 2006 2007 2008 2009 2010 2011 2012 Authors (n) 7 Author affiliations (n) 4 Unreported Sample size Median per trial (10th–90th percentile) Median per treatment group per trial (10th-90th percentile) Unreported
n (%)
300 (91.5) 28 (8.5) 8 (2.4) 292 (89.0) 28 (8.5) 61 (18.6) 45 (13.7) 37 (11.3) 34 (10.4) 34 (10.4) 1 (0.3) 3 (0.9) 5 (1.5) 3 (0.9) 9 (2.7) 6 (1.8) 19 (5.8) 24 (7.3) 24 (7.3) 34 (10.4) 49 (14.9) 79 (24.1) 72 (22.0) 256 (78.0) 57 (17.4) 15 (4.6) 305 (93.0) 12 (3.7) 6 (1.8) 5 (1.5) 100 (30–148) 50 (15–74) 93 (28.4)
and the respiratory system (10.4%). From 1999 to 2012, the number of RCTs increased from 0.3% to 22%. Most of the research was conducted by fewer than four authors (78%) at a single centre (82.4%). With unreported abstracts excluded, the number of randomized participants ranged from 30 to 4895. The median total sample size was 100 (10th to 90th percentile: 30–148) and 50 (15–74) for the treatment group.
CONSORT checklist assessment Analysis of fulfilment of the CONSORT abstracts checklist revealed most abstracts clearly reported outcomes (97.9%), interventions (97.3%) and objectives (97.0%). In contrast, the
© 2014 John Wiley & Sons, Ltd.
Table 2 Percentage distribution of scoring for each quality item in CONSORT checklist for abstracts
CONSORT item Title Methods Trial design Participants Interventions Objective Outcome Randomization Blinding Results Numbers randomized Recruitment Numbers analysed Outcome Harms Conclusions Trial registration Funding
Adequate n (%) 18 (5.5)
Inadequate n (%) 0
No description n (%) 310 (94.5)
10 (3.0) 5 (1.5) 319 (97.3) 318 (97.0) 321 (97.9) 3 (0.9) 3 (0.9)
0 323 (98.5) 9 (2.7) 10 (3.0) 4 (1.2) 325 (99.1) 26 (7.9)
318 (97.0) 0 0 0 3 (0.9) 0 299 (91.2)
240 (73.2) 0 9 (2.7) 61 (18.6) 16 (4.9) 233 (71.0) 7 (2.1) 0
0 0 4 (1.2) 267 (81.4) 71 (21.7) 95 (29.0) 0 0
88 (26.8) 328 (100) 315 (96.0) 0 241 (73.5) 0 321 (97.9) 328 (100)
following items were typically inadequately reported: randomization (99.1%), participant (98.5%) and outcomes of the results (81.4%). In addition, there was frequently no description of the following items: recruitment (100%), funding (100%), trial registration (97.9%), trial design (97.0%), number analysed (96.0%), title (94.5%) and blinding (91.2%).We have presented these results in Table 2.
Comparison of reporting quality between Chinese and English abstracts Of 300 included abstracts in Chinese, five items were reported in over 50% of cases: outcome (97.7%), interventions (97.3%), objective (97.0%), number randomized (74.7%) and conclusions (68.7%). In addition to those five items, title (64.3%) and outcome (71.4%) were reported by over 50% of the English abstracts. However, no abstracts in Chinese reported the following seven items: title, trial design, randomization, blinding, recruitment, trial registration and funding. Abstracts in English never reported two items: recruitment and funding. Comparing abstracts in Chinese and English, there are statistical differences in nine items. These included title (0 vs. 64.3%, P < 0.00001), trial design (0 vs. 35.7%, P < 0.0001), randomization (0 vs. 10.7%, P = 0.004), blinding (0 vs. 10.7%, P = 0.004), numbers analysed (0.3% vs. 28.6%, P < 0.0001), outcome (13.7% vs. 71.4%, P < 0.00001), harms (2.7% vs. 28.6%, P < 0.00001), conclusions (68.7% vs. 96.4%, P = 0.014) and trial registration (0 vs. 25%, P = 0.0003;). Regarding the total scores of reporting quality, abstracts published in English fulfilled significantly more CONSORT items than did abstracts in Chinese (Chinese vs. English: 6.47 ± 0.63 vs. 8.5 ± 1.72, P < 0.00001; Table 3). 829
Quality of RCTs on clinical pathway
Q. Cui et al.
Table 3 Assessment of included abstracts on clinical pathway according to CONSORT checklist items Chinese (n = 300)
CONSORT item Title Methods Trial design Participants Interventions Objective Outcome Randomization Blinding Results Numbers randomized Recruitment Numbers analysed Outcome Harms Conclusions Trial registration Funding Total score*
High impact (n = 8) 0
Low impact (n = 292)
Total
0
0
English (n = 28)
High-impact vs. low-impact (P-value for difference)
Chinese vs. English (P-value for difference)
18 (64.3%)
–
Journal of Evaluation in Clinical Practice ISSN 1365-2753
Does the CONSORT checklist for abstracts improve the quality of reports of randomized controlled trials on clinical pathways? Qi Cui MM,1,2 Jinhui Tian MD,2 Xuping Song MM2 and Kehu Yang MM3 1 2
Research Fellow, The First Hospital of Lanzhou University, Lanzhou University, Lanzhou, China Research Fellow, 3Professor, Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou, China
Keywords abstracts, clinical pathway, randomized controlled trial, research design Correspondence Prof Kehu Yang Evidence-Based Medicine Center, School of Basic Medical Sciences Lanzhou University No.199, Donggang West Road, Chengguan District Lanzhou, Gansu 730000 China E-mail: [email protected] Accepted for publication: 14 May 2014 doi:10.1111/jep.12200
Abstract Rationale, aims and objectives The extension of the Consolidated Standards of Reporting Trials (CONSORT) statement provides reporting guidelines to improve the reporting quality of randomized controlled trials (RCTs). This present study was aim to assess the reporting quality of abstracts of RCTs on clinical pathway. Methods Eight databases were searched from inception to November 2012 to identify RCTs. We extracted basic information and CONSORT items from abstracts. Each abstract was assessed independently by two reviewers. Statistical analyses were performed with SPSS 13.0. Level of significance was set at P < 0.05. Results 328 abstracts were included. 300 (91.5%) were published in Chinese, of which 292 were published on high impact factor journals. 28 English abstracts were all published on Science Citation Index (SCI) journals. (1) Intervention, objective and outcome were almost fully reported in all abstracts, while recruitment and funding were never reported. (2) There are nine items (P < 0.05) in Chinese that were of low quality compared with in English. There was statistically difference on total score between Chinese and English abstracts (P < 0.00001). (3) There was no difference in any items between high and low impact factor journal in China. (4) In SCI journals, there were significant changes in reporting for three items trial design (P = 0.026), harms (P = 0.039) and trial registration (P = 0.019) in different periods (pre- and post-CONSORT), but only the numbers of randomized (P = 0.003) changed in Chinese abstracts. Conclusions The reporting quality of abstracts of RCTs on clinical pathway still should be improved. After the publication of CONSORT for abstracts guideline, the RCT abstracts reporting quality were improvement to some extent. The abstracts in Chinese journals showed non-adherence to the CONSORT for abstracts guidelines.
Introduction Randomized controlled trials (RCTs) are considered the highest grade of evidence in the hierarchy of research designs [1]. The RCT, more than any other methodology, can have a powerful and immediate impact on patient care. For RCTs to ultimately benefit patients, the published report should meet the highest possible standards [2]. In some geographic areas, an RCT abstract may be the only portion of the article to which health professionals have easy access, and health care decisions may be made solely according to the information in the abstract [3]. Clear, transparent and sufficiently detailed abstracts for clinical trials are important because readers often base their assessment of a trial on such information [4].
The Consolidated Standards for Reporting Trials (CONSORT) for abstracts aim to improve abstract reporting of RCTs published in journal articles and conference proceedings. CONSORT helps RCT abstract authors provide the detail and clarity needed by readers wishing to assess a trial’s validity and the applicability of its results [3]. The number of systematic reviews about clinical pathways is increasing. Failure to describe the methodology accurately in abstracts might cause the research to be overlooked by readers during casual scanning. Such failure could also complicate study identification during retrieval for meta-analysis, with significant potential effects on health care delivery [5]. The aim of our study was to investigate the reporting quality of abstracts of RCTs on clinical pathways and to examine if there was any improvement in reporting after the CONSORT for abstracts
Journal of Evaluation in Clinical Practice 20 (2014) 827–833 © 2014 John Wiley & Sons, Ltd.
827
Quality of RCTs on clinical pathway
was published. We also aim to identify the differences between the reporting quality of high and low impact factor journals in China and Science Citation Index (SCI) journals.
Methods Selection of RCTs PubMed (1966–2012.11), the Cochrane Library (Issue 11, 2012), EMBASE (1974–2012.11), Web of Science (1974–2012.11), the China Journal Full-text Database (1994–2012.11), Chinese Scientific Journals Full-text Database (1989–2012.11), Chinese Biomedical Literature Database (1978–2012.11) and the WANFANG Database (1980–2012.11) were searched. The following search strategy and keywords were used to access the records: Critical pathways [Mesh] or clinical pathway [Title/Abstracts] or clinical pathways [Title/Abstracts] or clinical path [Title/Abstracts] or clinical paths [Title/Abstracts] or critical pathway [Title/ Abstracts] or critical pathways [Title/Abstracts] or critical path [Title/Abstracts] or critical paths [Title/Abstracts] or care pathway [Title/Abstracts] or care pathways [Title/Abstracts] or care path [Title/Abstracts] or care paths [Title/Abstracts] or care map [Title/Abstracts] or care maps [Title/Abstracts] or care protocol [Title/Abstracts] or care protocols [Title/Abstracts] and random* [All fields]. The inclusion criteria were as follows. RCT abstracts of interventions found using the keywords above were selected. We included abstracts in which the investigators described a random component in the sequence generation process. These descriptions included referring to a random number table; using a computer random number generator; coin tossing; shuffling cards or envelopes; throwing dice; or drawing of lots as defined by the Cochrane Handbook. We also included abstracts in which the allocation of participants to interventions was described by the words ‘random’, ‘randomly allocated’, ‘randomized’ or ‘randomization’ [6]. Only structured abstracts were included. Each study was assessed independently by two reviewers. Study eligibility was identified by screening titles, abstracts, or the full text. When there were differences, consensus was reached through discussion and confirmed by the third researcher.
Data extraction Two well-trained reviewers extracted data and assessed the abstracts according to the CONSORT for abstracts. A consensus process was used to resolve disagreements. For each included abstract, we extracted data on the items recommend by the extension of the CONSORT for abstracts [3]. Ratings of ‘adequate’, ‘inadequate’ and ‘no description’ – indicating level of detail the author reported – were assigned for each item. The score for each item ranged from 0 to 1 [7]. Zero represented no description of the item, 0.5 represented inadequate description and 1 represented adequate description. Additionally, descriptive information such as journal name, publication year and country; number of authors; number of author affiliations; sample sizes; and involved diseases were recorded. See Appendix A for a table summarizing the data extracted. 828
Q. Cui et al.
Data analysis We classified abstracts according to the citation and the year that the CONSORT extension was published (pre-CONSORT before 2009, post-CONSORT during or after 2009). Citations were classified as high impact factor journals in China, low impact factor journals in China and SCI citations. We classified journals as high impact factor if they were included in the Chinese Science Citation Database (CSCD). The diseases to which clinical pathways referred were grouped by the International Classification of Diseases (ICD-10). Proportions of reported items in two groups were compared using independent sample Student’s t-test. Data for descriptive statistics were performed using Microsoft Excel 2007 and SPSS (version 13.0; SPSS, Inc., Chicago, IL, USA). Level of significance was set at P < 0.05.
Results Our electronic search strategy initially identified 8813 records. Of these, 7603 non-RCT abstracts and 882 non-clinical pathway abstracts were excluded, as presented in Fig. 1. A total of 328 RCT abstracts about clinical pathways were included for the analysis.
Study characteristics As reported in Table 1, 300 (91.5%) RCTs were published in Chinese and 28 (8.5%) in other languages. Eight (2.4%) were cited in high impact factor journals in China and 28 (8.5%) were cited in SCI. The majority of RCTs focused on diseases of the circulatory system (18.6%), followed by diseases of the digestive system (13.7%), neoplasms (11.3%), the genitourinary system (10.4%)
Initial search in database (n = 8813)
7603 non-RCT abstracts excluded
1210 potentially eligible evaluations
882 non-clinical pathway abstracts excluded 328 RCT abstracts on clinical pathway included Figure 1 Flow chart of the literature search and identification of abstracts for assessment of the quality of reporting.
© 2014 John Wiley & Sons, Ltd.
Q. Cui et al.
Quality of RCTs on clinical pathway
Table 1 Characteristics of the included trial abstracts Abstract characteristic (n = 328 abstracts) Language Chinese English Journal CSCD Non-CSCD SCI Classification of diseases Diseases of the circulatory system Diseases of the digestive system Neoplasms Diseases of the genitourinary system Diseases of the respiratory system Publication year 1999 2000 2002 2003 2005 2004 2006 2007 2008 2009 2010 2011 2012 Authors (n) 7 Author affiliations (n) 4 Unreported Sample size Median per trial (10th–90th percentile) Median per treatment group per trial (10th-90th percentile) Unreported
n (%)
300 (91.5) 28 (8.5) 8 (2.4) 292 (89.0) 28 (8.5) 61 (18.6) 45 (13.7) 37 (11.3) 34 (10.4) 34 (10.4) 1 (0.3) 3 (0.9) 5 (1.5) 3 (0.9) 9 (2.7) 6 (1.8) 19 (5.8) 24 (7.3) 24 (7.3) 34 (10.4) 49 (14.9) 79 (24.1) 72 (22.0) 256 (78.0) 57 (17.4) 15 (4.6) 305 (93.0) 12 (3.7) 6 (1.8) 5 (1.5) 100 (30–148) 50 (15–74) 93 (28.4)
and the respiratory system (10.4%). From 1999 to 2012, the number of RCTs increased from 0.3% to 22%. Most of the research was conducted by fewer than four authors (78%) at a single centre (82.4%). With unreported abstracts excluded, the number of randomized participants ranged from 30 to 4895. The median total sample size was 100 (10th to 90th percentile: 30–148) and 50 (15–74) for the treatment group.
CONSORT checklist assessment Analysis of fulfilment of the CONSORT abstracts checklist revealed most abstracts clearly reported outcomes (97.9%), interventions (97.3%) and objectives (97.0%). In contrast, the
© 2014 John Wiley & Sons, Ltd.
Table 2 Percentage distribution of scoring for each quality item in CONSORT checklist for abstracts
CONSORT item Title Methods Trial design Participants Interventions Objective Outcome Randomization Blinding Results Numbers randomized Recruitment Numbers analysed Outcome Harms Conclusions Trial registration Funding
Adequate n (%) 18 (5.5)
Inadequate n (%) 0
No description n (%) 310 (94.5)
10 (3.0) 5 (1.5) 319 (97.3) 318 (97.0) 321 (97.9) 3 (0.9) 3 (0.9)
0 323 (98.5) 9 (2.7) 10 (3.0) 4 (1.2) 325 (99.1) 26 (7.9)
318 (97.0) 0 0 0 3 (0.9) 0 299 (91.2)
240 (73.2) 0 9 (2.7) 61 (18.6) 16 (4.9) 233 (71.0) 7 (2.1) 0
0 0 4 (1.2) 267 (81.4) 71 (21.7) 95 (29.0) 0 0
88 (26.8) 328 (100) 315 (96.0) 0 241 (73.5) 0 321 (97.9) 328 (100)
following items were typically inadequately reported: randomization (99.1%), participant (98.5%) and outcomes of the results (81.4%). In addition, there was frequently no description of the following items: recruitment (100%), funding (100%), trial registration (97.9%), trial design (97.0%), number analysed (96.0%), title (94.5%) and blinding (91.2%).We have presented these results in Table 2.
Comparison of reporting quality between Chinese and English abstracts Of 300 included abstracts in Chinese, five items were reported in over 50% of cases: outcome (97.7%), interventions (97.3%), objective (97.0%), number randomized (74.7%) and conclusions (68.7%). In addition to those five items, title (64.3%) and outcome (71.4%) were reported by over 50% of the English abstracts. However, no abstracts in Chinese reported the following seven items: title, trial design, randomization, blinding, recruitment, trial registration and funding. Abstracts in English never reported two items: recruitment and funding. Comparing abstracts in Chinese and English, there are statistical differences in nine items. These included title (0 vs. 64.3%, P < 0.00001), trial design (0 vs. 35.7%, P < 0.0001), randomization (0 vs. 10.7%, P = 0.004), blinding (0 vs. 10.7%, P = 0.004), numbers analysed (0.3% vs. 28.6%, P < 0.0001), outcome (13.7% vs. 71.4%, P < 0.00001), harms (2.7% vs. 28.6%, P < 0.00001), conclusions (68.7% vs. 96.4%, P = 0.014) and trial registration (0 vs. 25%, P = 0.0003;). Regarding the total scores of reporting quality, abstracts published in English fulfilled significantly more CONSORT items than did abstracts in Chinese (Chinese vs. English: 6.47 ± 0.63 vs. 8.5 ± 1.72, P < 0.00001; Table 3). 829
Quality of RCTs on clinical pathway
Q. Cui et al.
Table 3 Assessment of included abstracts on clinical pathway according to CONSORT checklist items Chinese (n = 300)
CONSORT item Title Methods Trial design Participants Interventions Objective Outcome Randomization Blinding Results Numbers randomized Recruitment Numbers analysed Outcome Harms Conclusions Trial registration Funding Total score*
High impact (n = 8) 0
Low impact (n = 292)
Total
0
0
English (n = 28)
High-impact vs. low-impact (P-value for difference)
Chinese vs. English (P-value for difference)
18 (64.3%)
–
