Journal of Evidence-Based Medicine ISSN 1756-5391
ORIGINAL ARTICLE
Quality of reporting clinical trials published in five leading Sri Lankan medical journals Chrishantha Abeysena and Indeewari Poddalgoda Department of Public Health, Faculty of Medicine, University of Kelaniya, Ragama, Sri Lanka
Keywords Consort; randomization; reporting quality; trial. Correspondence Chrishantha Abeysena, Department of Public Health, Faculty of Medicine, University of Kelaniya, P.O. Box 6, Thalagolla Road, Ragama, Sri Lanka. Tel: 0094 112953411; Fax: 0094 112958337; Email: [email protected] Received 19 May 2013; accepted for publication 22 July 2013. doi: 10.1111/jebm.12069
Abstract Objectives: To assess the quality of reporting of clinical trials published in five leading Sri Lankan medical journals. Methods: Six medical journals were hand searched for clinical trials published from 1982 to 2011. Eligible criteria were all randomized and non-randomized clinical trials conducted in humans. A checklist was developed based on CONSORT and TREND recommendations. Each study was independently evaluated by two reviewers. Outcome measures were presence of checklist items in published reports. Results: Fifteen randomized and 24 non-randomized parallel group trials from 724 studies in five journals met the inclusion criteria. Out of 39 trials, 39 (97%) clearly described the objectives, 16 (41%) defined the periods of recruitment, 7 (18%) reported how sample size was determined, 10 (25.6%) reported the methods to enhance the quality of measurements, 20 (51%) reported baseline demographic and clinical characteristics of each group, 4 (10%) showed flow diagrams, 23 (69%) reported statistical methods used to compare groups for primary outcomes, 21 (54%) reported effect size, 4 (10%) reported its precision, and 20 (51%) interpreted the results in the context of current evidence, and 5 (13%) described the generalizability of the findings. Of the 15 randomized trials, only one (7%) reported sequence generation, 5 (33%) allocation concealment, 9 (60%) reported blinding status of participants or investigators, and 2 (13%) reported intention to treat analysis. Conclusions: Reporting of several essential recommendations remained suboptimal. Education and training of trial methods and awareness of the CONSORT and TREND statements and more attention to the quality of reporting may improve matters.
Introduction Randomized controlled trials (RCTs) provide essential evidence of the effect of interventions and are regarded as the highest in the hierarchy of evidence. High quality, comprehensive, transparent reporting with clarity is recognized as an important tool for assessing reliability and validity of the results and likely to improve the interpretation of RCTs and minimize biased conclusions (1, 2). Such trials need to be appraised by readers and policy makers in order to decide whether to incorporate evidence into clinical practice and policy. Inadequate reporting makes the interpretation of trials difficult. Moreover, inadequate reporting borders on unethical
practice when biased results receive false credibility (2). There is, however, strong evidence to indicate that the quality of the reporting of RCTs in the medical literature is less than optimal (2–5). In 1996, the Consolidated Standards of Reporting Trials (CONSORT) statement for the reporting of clinical trials was produced (6). It was followed by its revision in 2001 and 2010 in order to keep abreast with the recent advances in research methodology and other related concepts (2, 7). CONSORT statement can also be applied for other RCT designs such as cluster randomized trials (9). These are included as extensions of CONSORT statement (9, 10). In addition, the updated version of Explanation and Elaboration Article
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will aid in explaining the inclusion of each checklist item, methodological background and give published examples of transparent reporting (11). CONSORT and its extensions will invariably influence the study design, conduct and analysis of a trial as well (12). Thus it will encourage the investigators to both conduct and report their research in improved standards. Evidence-based public health decisions are based on evaluations of intervention studies with randomized and nonrandomized designs. Therefore, the Transparent Reporting of Evaluations with Nonrandomized Designs (TREND) statement was developed to improve the reporting standards of non-randomized evaluations of behavioral and public health interventions. The TREND statement was first published in 2004 (13). The TREND statement complements the CONSORT statement developed for randomized controlled trials. The TREND checklist is developed in a way that’s consistent with the CONSORT checklist for the reporting of RCTs (13). These reporting guidelines are endorsed by several international journals (14). However, Sri Lankan medical journals have not yet endorsed them. The objective of this study is to assess the quality of reporting of clinical trials published in five leading Sri Lankan medical journals. Therefore, the findings of this study would help to improve not only the quality of reporting but the quality of trials by proper planning the study as well.
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Table 1 Background information of clinical trials published in selected Sri Lankan journals Trial design
n (%)
Single group design Parallel group design Two groups Three or more groups Randomized controlled trial Non-randomized trial Drug trial Externally funded trial No. of authors >3
10 (25.6) 29 (74.4) 21 (72.5) 8 (27.5) 15 (38.5) 24 (71.5) 33 (82) 18 (46) 17 (43.5)
consensus result. We did not assess the appropriateness and the adequacy of the content. For examples, we judged “Yes” for the item “Statistical methods used to compare groups for primary outcome” if they reported any statistical method irrespective of whether it was appropriate for the context. Further, we judged “Yes” for the item “Methods used to implement the allocation concealment” if they reported any clue for concealment of an allocation irrespective of the adequacy of the description. Outcome measures were presence of checklist items in published reports. In order to assess adherence to the checklist items, we calculated the number and percentage of trials describing each of the items separately for all trials and RCTs.
Methods Six leading medical journals (including Ceylon Medical Journal, Sri Lanka Journal of Obstetrics and Gynaecology, Journal of the Community Physician of Sri Lanka, The Sri Lanka Journal of Surgery, Journal of the Ceylon College of Physicians, and Sri Lanka Journal of Child Health) were hand searched for clinical trials published from 1982 to 2011. Hand searching of the titles, abstracts and full text articles for the key words “trial”, “intervention study”, and “experimental study” were done. Concurrently the objectives, methods and results sections were assessed independently by two reviewers for an intervention (assessing efficacy of a drug or procedure) and came to consensus for inclusion. Inclusion criteria were all randomized, non-randomized and single group clinical trials conducted in humans. We retrieved 724 studies from the selected journals but couldn’t find any trial from Sri Lanka Journal of Child Health. Of the remaining five journals, 39 trials were selected. An operational checklist was developed based on revised CONSORT 2001 (2) and TREND 2004 (13) recommendations. Operational definitions of each checklist item were discussed by the reviewers in detail. Each trial was then assessed for every item on the checklist and summarized (Yes or No) independently by two reviewers, who also later arrived at a
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Results We retrieved 39 trials (15–53) for assessment of the quality of reporting, of which 32 (82%) were from the Ceylon Medical Journal. Of 39 trials, 15 (38.5%) were randomized clinical trials (39–53) and 24 (61.5%) were non-randomized trials (15–38) (Table 1). All RCTs were parallel group and phase III trials and 11 (73%) (39–44, 49–53) published after CONSORT was introduced in 1996. Except one which was conducted in India (41), all the other trials were conducted in Sri Lanka. Of 39 trials, 38 (97.4%) (15–46, 48–53) had abstracts. Eleven (28%) (15, 18, 20–23, 42, 43, 49, 50) reported the study design in the title and 23 (59%) (15, 16, 18, 20– 25, 32–34, 36, 42–44, 46, 48–50, 52, 53) in the abstract and 10 (25.6%) (19, 21–23, 35, 38, 42–44, 47) in the methods. The accepted terminology for the study designs were reported only in 12 (30.7%) trials and 4 (10%) (21–23, 25) were reported as either prospective studies or descriptive studies in the main manuscripts, and 13 (36%) (17, 26–31, 35, 37, 39– 41, 45) had not mentioned the study design anywhere of the article, of which 4 (30.7%) (39–41, 45) were RCTs. Of 14 abstracts of RCTs, 9 (64%) (39, 41, 43, 46, 49–53) reported that participants were allocated randomly.
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Table 2 Items reported in all trials and randomized controlled trials in selected Sri Lankan journals [n (%)] Randomized controlled trial
All trials Items reported
Yes
No
Yes
No
Scientific background and explanation of rationale Clear statement of hypothesis or objectives Study design was reported in the methods Description of settings/location of recruitment Period of recruitment and follow up Eligibility criteria for participants Statistical methods used to compare groups for primary outcome Description of baseline characteristics Flow of participants through each stage Identification and definition of primary outcome measures * Identification and definition of secondary outcome measures Any methods to enhance quality of measurements Sample size calculation Summary results in each group Effect measures Confidence intervals * Side effects/adverse events and unintended effects in each intervention Interpretation of the results, taking into account study hypothesis Interpretation of the results, taking into account sources of potential biases Interpretation of the results, taking into account imprecision General interpretation of the results in the context of current evidence External validity of trial results
38 (97) 38 (97) 10 (25.6) 34 (87) 16 (41) 38 (97) 23 (69) 20 (51) 12 (31) 38 (97) 05 (13) 10 (25.6) 07 (18) 37 (95) 21 (54) 04 (10) 22 (59.5) 35 (90) 00 (00) 01 (03) 20 (51) 05 (13)
01 (03) 01 (03) 29 (74.4) 05 (13) 23 (59) 01 (03) 16 (41) 19 (49) 27 (69) 01 (03) 33 (87) 29 (74.4) 32 (82) 02 (05) 18 (46) 35 (90) 15 (40.5) 04 (10) 39 (100) 33 (97) 19 (49) 34 (87)
14 (93) 14 (93) 4 (27) 13 (87) 08 (53) 15 (100) 11 (73) 11 (73) 05 (33) 15 (100) 03 (20) 05 (33) 04 (27) 15 (100) 06 (40) 03 (20) 10 (67) 13 (87) 00 (00) 00 (00) 10 (67) 01 (7)
01 (07) 01 (07) 11 (73) 02 (13) 07 (47) 00 (00) 04 (27) 04 (27) 10 (67) 00 (00) 12 (80) 10 (67) 11 (73) 00 (00) 09 (60) 12 (80) 05 (33) 02 (13) 15 (100) 15 (100) 05 (33) 14 (93)
*Reporting of the definition of the secondary outcome; these items are common to both CONSORT & TREND.
More than 80% of the all trials and RCTs reported scientific background, clearly-written objectives, settings/location of recruitment, inclusion criteria for participants, definition of primary outcome measure, summary results in each group, and interpretation of the results taking into account study hypothesis (Table 2). Table 2 also shows that less than 50% of all trials and RCTs reported flow of participants through each stage, definition of secondary outcome measures, any methods to enhance quality of measurements, sample size calculation, confidence intervals, interpretation of the results taking into account imprecision and external validity. Two trials (5%) (37, 50) reported adjusted analysis and both of were non-RCTs. Only 4 (10%) trials (15, 20, 43, 49) depicted flow diagram. Of 39 trials, no trial reported interim analysis/stopping rules, subgroup analysis, dangers associated with multiplicity of analysis, interpretation of the results, taking into account sources of potential biases and any protocol deviations. More than 80% of the drug trials reported that the dose, frequency, route and duration of both the intervention and the control drug (Table 3). Table 3 also shows that less than 50% of the blinded trials reported who was blinded and few RCTs reported description of randomization, concealment of an allocation and use of intention to treat analysis.
No RCT reported who generated the allocation sequence and who enrolled participants. The success of blinding was not evaluated in all blinded trials. Ethical clearance was granted by an Ethics Review Committee was reported by 14 (36%) (15, 20–22, 24, 28, 37, 41–44, 49, 50, 52) of all trials and 7 (47%) (41–44, 49–51) of RCTs. It is reported that the consent was obtained by 16 (41%) (15, 16, 18–20, 22– 25, 35, 41, 42, 44, 49–51) studies.
Discussion Our study showed that the most striking feature of reporting quality was the lack of adherence to methodologically important items and underreporting of presentation of statistics. Items related to internal validity of RCTs such as randomization, concealment allocation, blinding and intention to treat analysis were reported in very few trials, which hampers the quality assessment of these trials. In our study, method of randomization and intention to treat analysis were reported only in 7% and 13% of trials, respectively, which were very lower than the percentage published by other studies (between 15% to 59% and 18% to 79%, respectively) (4, 54–58). One reason for less reporting could be due to the fact that we assessed the trials published since 1982, far before the CONSORT, where the others
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Table 3 Items reported in drug trials and randomized controlled trials in selected Sri Lankan journals [n (%)] All drug trials
Randomized controlled trial
Items reported
Yes
No
Yes
No
Intervention group – drug dose Intervention group – frequency of the drug Intervention group – route of the drug Intervention group – duration of the drug Control group – drug dose Control group – frequency of the drug Control group – route of drug Control group – duration of the drug Blinding was (or not) performed Blinded participants Blinded treatment providers Blinded assessors Method of generation of random sequence Any restrictions such as blocking/stratification Who generated the allocation sequence Who enrolled participants Methods used to implement the allocation concealment Use of intention-to-treat principle
33 (100) 32 (97) 32 (97) 31 (94) 23 (100) 22 (96) 21 (91) 21 (91) 13 (33) 05 (41.6) 03 (25) 03 (25)
00 (00) 01 (03) 01 (03) 02 (06) 00 (00) 01 (04) 02 (09) 02 (09) 26 (67) 07(58.4) 09 (75) 09 (75)
15 (100) 15 (100) 15 (100) 15 (100) 15 (100) 15 (100) 14 (93) 15 (100) 09 (60) 03 (33) 03 (33) 02 (22) 01 (7) 01 (7) 00 (0) 00 (0) 05 (33) 02 (13)
00 (00) 00 (00) 00 (00) 00 (00) 00 (00) 00 (00) 01 (07) 00 (00) 06 (40) 06 (67) 06 (67) 07 (78) 14 (93) 14 (93) 15 (100) 15 (100) 10 (67) 13 (86.6)
restricted their search strategies to databases and published in recent few years. One larger review on traditional Chinese RCTs published since 1978 reported that adequate method of randomization was 12% (56). In contract to that most of these studies assessed adequate description of method of randomization (55–57, 59) and intention to treat analysis (4, 54, 55, 59) where we assessed whether the reporting of a method of randomization and intention to treat analysis irrespective of the description was adequate or not. In our study, reporting of allocation concealment was 33%. In contrast to that, others (55, 56, 59) reported very low reporting of allocation concealment range in between 3% to 7% where they reported adequate description of allocation concealment. We couldn’t find any trial which described allocation concealment adequately. One study which searched trials published recently reported that it was 69% (57). According to our study, 33% of all trials and 60% of RCTs reported blinding status. However, as in other studies (55, 60), details of blinding were under reported. One study reported that it was 83% (57) and others lower than our study (4, 54, 55). Studies have shown that non-randomized trials and RCTs that do not incorporate blinding are overestimating the treatment effects (61, 62). In our study, reporting of the pre-study sample size calculation was 18% of all trials and 27% of RCTs. Our results were consistent with two other studies assessed RCTs reporting quality (54, 55). Another study reported that it was 77% (57). Reporting of confidence interval for effect measures was 10% for all trials and 20% for RCTs. Two studies (5, 55) assessed RCTs published in 2003 reported that
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use of confidence intervals was 36% (5) and 15%, respectively (55). Details that could be used to assess the external validity were present in 13% of all trials and 7% of RCTs in our study. Two studies assessed RCTs published in 2003 and 2004 reported that much higher values 100% (55) and 61% (54), respectively. In our study, flow diagram was included in 10% of trials. Several studies (54, 55, 59) showed that depiction of flow diagrams was less than 10% and others (4, 57) more than 10%. Trials of higher methodological quality were more likely to provide information about their ethical aspects (63, 64). According to our study approval of the protocol from an Ethics Review Committee and obtaining consent from the participants were 36% and 41% of all trials, respectively. Four studies (54, 59, 63, 64) showed that reporting of ERC approval and request for informed consent were much higher (70%-95%) than our study. Our study is the first one in Sri Lanka to evaluate the reporting quality of trials. This study has some limitations. We couldn’t assess the adequacy of the description of the items due to unavailability of reporting. As only 15 trial reports were RCTs, we could not compare between the trials published before and after the CONSORT, even though all the journals do not adopt the CONSORT. Previous studies showed that journals’ endorsement of CONSORT and its extensions seems to be associated with improvements in quality of reporting of RCTs (12, 55, 65, 66). Previous studies have also showed the importance of adhering to CONSORT statement and related extensions in the
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“Information for Authors” of medical journals for improving reporting of RCTs (54, 67, 68). One study showed that more than 60% of the authors who reported their studies in the principal cardiothoracic journals were not aware of it (55). Previous studies reported that the involvement of a trial methodologist (epidemiologist or biostatistician) improves reporting quality (69, 70). Further, some studies indicated that the reporting quality had somewhat improved over time (57, 71, 72) probably due to influence of CONSORT and its implementation. The quality of reporting non-randomized and randomized controlled trials published in Sri Lankan journals is suboptimal. We recommend that increase education and training in the designing and reporting of clinical trial methodology and biostatistics and the awareness of the CONSORT and TREND statements among the authors, peer-reviewers and editors may also help improve the quality of reporting.
Acknowledgements We would like to express our appreciation to Ms. M. P. L. R. Marasinghe, Assistant Librarian, Faculty of Medicine, University of Kelaniya, and Dr. T.I. Pathirana for retrieving some articles.
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53. Samaranayake SW, Perera BJC. Paper spacers coupled to metered dose inhalers in family practice. Ceylon Medical Journal 1998; 43(3): 147–50. 54. Uetani K, Nakayama T, Ikai H, Yonemoto N, Moher D. Quality of reports on randomized controlled trials conducted in Japan: evaluation of adherence to the CONSORT Statement. Inter Med 2009; 48(5): 307–13. 55. Tiruvoipati R, Balasubramanian SP, Atturu G, Peek GJ, Elbourne D. Improving the quality of reporting randomized controlled trials in cardiothoracic surgery: The way forward. J Thorac Cardiovasc Surg 2006; 132(2): 233–40. 56. He J, Du L, Liu G, Fu J, He X, Yu J, et al. Quality assessment of reporting of randomization, allocation concealment, and blinding in traditional Chinese medicine RCTs: a review of 3159 RCTs identified from 260 systematic reviews. Trials 2011; 12(1): 122. 57. DeMauro SB, Giaccone A, Kirpalani H, Schmidt B. Quality of reporting of neonatal and infant trials in high-impact journals. Pediatrics 2011; 128(3): e639–e44. 58. van der Meersch A, Dechartres A, Ravaud P. Quality of reporting of bioequivalence trials comparing generic to brand name drugs: a methodological systematic review. PLoS ONE 2011; 6(8): e23611. doi:10.1371/journal.pone.0023611 59. Mills E, Loke YK, Wu P, Montori VM, Perri D, Moher D, et al. Determining the reporting quality of RCTs in clinical pharmacology. Br J Clin Pharmacol 2004; 58(1): 61–5. 60. Schulz KF, Grimes DA, Altman DG, Hayes RJ. Blinding and exclusions after allocation in randomised controlled trials: survey of published parallel group trials in obstetrics and gynecology. BMJ 1996; 312: 742–4. 61. Grimes DA. Randomized controlled trials: “it ain’t necessarily so.” Obstet Gynecol 1991; 78(4): 703–4. 62. Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA 1995; 273(5): 408–12.
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ORIGINAL ARTICLE
Quality of reporting clinical trials published in five leading Sri Lankan medical journals Chrishantha Abeysena and Indeewari Poddalgoda Department of Public Health, Faculty of Medicine, University of Kelaniya, Ragama, Sri Lanka
Keywords Consort; randomization; reporting quality; trial. Correspondence Chrishantha Abeysena, Department of Public Health, Faculty of Medicine, University of Kelaniya, P.O. Box 6, Thalagolla Road, Ragama, Sri Lanka. Tel: 0094 112953411; Fax: 0094 112958337; Email: [email protected] Received 19 May 2013; accepted for publication 22 July 2013. doi: 10.1111/jebm.12069
Abstract Objectives: To assess the quality of reporting of clinical trials published in five leading Sri Lankan medical journals. Methods: Six medical journals were hand searched for clinical trials published from 1982 to 2011. Eligible criteria were all randomized and non-randomized clinical trials conducted in humans. A checklist was developed based on CONSORT and TREND recommendations. Each study was independently evaluated by two reviewers. Outcome measures were presence of checklist items in published reports. Results: Fifteen randomized and 24 non-randomized parallel group trials from 724 studies in five journals met the inclusion criteria. Out of 39 trials, 39 (97%) clearly described the objectives, 16 (41%) defined the periods of recruitment, 7 (18%) reported how sample size was determined, 10 (25.6%) reported the methods to enhance the quality of measurements, 20 (51%) reported baseline demographic and clinical characteristics of each group, 4 (10%) showed flow diagrams, 23 (69%) reported statistical methods used to compare groups for primary outcomes, 21 (54%) reported effect size, 4 (10%) reported its precision, and 20 (51%) interpreted the results in the context of current evidence, and 5 (13%) described the generalizability of the findings. Of the 15 randomized trials, only one (7%) reported sequence generation, 5 (33%) allocation concealment, 9 (60%) reported blinding status of participants or investigators, and 2 (13%) reported intention to treat analysis. Conclusions: Reporting of several essential recommendations remained suboptimal. Education and training of trial methods and awareness of the CONSORT and TREND statements and more attention to the quality of reporting may improve matters.
Introduction Randomized controlled trials (RCTs) provide essential evidence of the effect of interventions and are regarded as the highest in the hierarchy of evidence. High quality, comprehensive, transparent reporting with clarity is recognized as an important tool for assessing reliability and validity of the results and likely to improve the interpretation of RCTs and minimize biased conclusions (1, 2). Such trials need to be appraised by readers and policy makers in order to decide whether to incorporate evidence into clinical practice and policy. Inadequate reporting makes the interpretation of trials difficult. Moreover, inadequate reporting borders on unethical
practice when biased results receive false credibility (2). There is, however, strong evidence to indicate that the quality of the reporting of RCTs in the medical literature is less than optimal (2–5). In 1996, the Consolidated Standards of Reporting Trials (CONSORT) statement for the reporting of clinical trials was produced (6). It was followed by its revision in 2001 and 2010 in order to keep abreast with the recent advances in research methodology and other related concepts (2, 7). CONSORT statement can also be applied for other RCT designs such as cluster randomized trials (9). These are included as extensions of CONSORT statement (9, 10). In addition, the updated version of Explanation and Elaboration Article
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will aid in explaining the inclusion of each checklist item, methodological background and give published examples of transparent reporting (11). CONSORT and its extensions will invariably influence the study design, conduct and analysis of a trial as well (12). Thus it will encourage the investigators to both conduct and report their research in improved standards. Evidence-based public health decisions are based on evaluations of intervention studies with randomized and nonrandomized designs. Therefore, the Transparent Reporting of Evaluations with Nonrandomized Designs (TREND) statement was developed to improve the reporting standards of non-randomized evaluations of behavioral and public health interventions. The TREND statement was first published in 2004 (13). The TREND statement complements the CONSORT statement developed for randomized controlled trials. The TREND checklist is developed in a way that’s consistent with the CONSORT checklist for the reporting of RCTs (13). These reporting guidelines are endorsed by several international journals (14). However, Sri Lankan medical journals have not yet endorsed them. The objective of this study is to assess the quality of reporting of clinical trials published in five leading Sri Lankan medical journals. Therefore, the findings of this study would help to improve not only the quality of reporting but the quality of trials by proper planning the study as well.
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Table 1 Background information of clinical trials published in selected Sri Lankan journals Trial design
n (%)
Single group design Parallel group design Two groups Three or more groups Randomized controlled trial Non-randomized trial Drug trial Externally funded trial No. of authors >3
10 (25.6) 29 (74.4) 21 (72.5) 8 (27.5) 15 (38.5) 24 (71.5) 33 (82) 18 (46) 17 (43.5)
consensus result. We did not assess the appropriateness and the adequacy of the content. For examples, we judged “Yes” for the item “Statistical methods used to compare groups for primary outcome” if they reported any statistical method irrespective of whether it was appropriate for the context. Further, we judged “Yes” for the item “Methods used to implement the allocation concealment” if they reported any clue for concealment of an allocation irrespective of the adequacy of the description. Outcome measures were presence of checklist items in published reports. In order to assess adherence to the checklist items, we calculated the number and percentage of trials describing each of the items separately for all trials and RCTs.
Methods Six leading medical journals (including Ceylon Medical Journal, Sri Lanka Journal of Obstetrics and Gynaecology, Journal of the Community Physician of Sri Lanka, The Sri Lanka Journal of Surgery, Journal of the Ceylon College of Physicians, and Sri Lanka Journal of Child Health) were hand searched for clinical trials published from 1982 to 2011. Hand searching of the titles, abstracts and full text articles for the key words “trial”, “intervention study”, and “experimental study” were done. Concurrently the objectives, methods and results sections were assessed independently by two reviewers for an intervention (assessing efficacy of a drug or procedure) and came to consensus for inclusion. Inclusion criteria were all randomized, non-randomized and single group clinical trials conducted in humans. We retrieved 724 studies from the selected journals but couldn’t find any trial from Sri Lanka Journal of Child Health. Of the remaining five journals, 39 trials were selected. An operational checklist was developed based on revised CONSORT 2001 (2) and TREND 2004 (13) recommendations. Operational definitions of each checklist item were discussed by the reviewers in detail. Each trial was then assessed for every item on the checklist and summarized (Yes or No) independently by two reviewers, who also later arrived at a
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Results We retrieved 39 trials (15–53) for assessment of the quality of reporting, of which 32 (82%) were from the Ceylon Medical Journal. Of 39 trials, 15 (38.5%) were randomized clinical trials (39–53) and 24 (61.5%) were non-randomized trials (15–38) (Table 1). All RCTs were parallel group and phase III trials and 11 (73%) (39–44, 49–53) published after CONSORT was introduced in 1996. Except one which was conducted in India (41), all the other trials were conducted in Sri Lanka. Of 39 trials, 38 (97.4%) (15–46, 48–53) had abstracts. Eleven (28%) (15, 18, 20–23, 42, 43, 49, 50) reported the study design in the title and 23 (59%) (15, 16, 18, 20– 25, 32–34, 36, 42–44, 46, 48–50, 52, 53) in the abstract and 10 (25.6%) (19, 21–23, 35, 38, 42–44, 47) in the methods. The accepted terminology for the study designs were reported only in 12 (30.7%) trials and 4 (10%) (21–23, 25) were reported as either prospective studies or descriptive studies in the main manuscripts, and 13 (36%) (17, 26–31, 35, 37, 39– 41, 45) had not mentioned the study design anywhere of the article, of which 4 (30.7%) (39–41, 45) were RCTs. Of 14 abstracts of RCTs, 9 (64%) (39, 41, 43, 46, 49–53) reported that participants were allocated randomly.
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Table 2 Items reported in all trials and randomized controlled trials in selected Sri Lankan journals [n (%)] Randomized controlled trial
All trials Items reported
Yes
No
Yes
No
Scientific background and explanation of rationale Clear statement of hypothesis or objectives Study design was reported in the methods Description of settings/location of recruitment Period of recruitment and follow up Eligibility criteria for participants Statistical methods used to compare groups for primary outcome Description of baseline characteristics Flow of participants through each stage Identification and definition of primary outcome measures * Identification and definition of secondary outcome measures Any methods to enhance quality of measurements Sample size calculation Summary results in each group Effect measures Confidence intervals * Side effects/adverse events and unintended effects in each intervention Interpretation of the results, taking into account study hypothesis Interpretation of the results, taking into account sources of potential biases Interpretation of the results, taking into account imprecision General interpretation of the results in the context of current evidence External validity of trial results
38 (97) 38 (97) 10 (25.6) 34 (87) 16 (41) 38 (97) 23 (69) 20 (51) 12 (31) 38 (97) 05 (13) 10 (25.6) 07 (18) 37 (95) 21 (54) 04 (10) 22 (59.5) 35 (90) 00 (00) 01 (03) 20 (51) 05 (13)
01 (03) 01 (03) 29 (74.4) 05 (13) 23 (59) 01 (03) 16 (41) 19 (49) 27 (69) 01 (03) 33 (87) 29 (74.4) 32 (82) 02 (05) 18 (46) 35 (90) 15 (40.5) 04 (10) 39 (100) 33 (97) 19 (49) 34 (87)
14 (93) 14 (93) 4 (27) 13 (87) 08 (53) 15 (100) 11 (73) 11 (73) 05 (33) 15 (100) 03 (20) 05 (33) 04 (27) 15 (100) 06 (40) 03 (20) 10 (67) 13 (87) 00 (00) 00 (00) 10 (67) 01 (7)
01 (07) 01 (07) 11 (73) 02 (13) 07 (47) 00 (00) 04 (27) 04 (27) 10 (67) 00 (00) 12 (80) 10 (67) 11 (73) 00 (00) 09 (60) 12 (80) 05 (33) 02 (13) 15 (100) 15 (100) 05 (33) 14 (93)
*Reporting of the definition of the secondary outcome; these items are common to both CONSORT & TREND.
More than 80% of the all trials and RCTs reported scientific background, clearly-written objectives, settings/location of recruitment, inclusion criteria for participants, definition of primary outcome measure, summary results in each group, and interpretation of the results taking into account study hypothesis (Table 2). Table 2 also shows that less than 50% of all trials and RCTs reported flow of participants through each stage, definition of secondary outcome measures, any methods to enhance quality of measurements, sample size calculation, confidence intervals, interpretation of the results taking into account imprecision and external validity. Two trials (5%) (37, 50) reported adjusted analysis and both of were non-RCTs. Only 4 (10%) trials (15, 20, 43, 49) depicted flow diagram. Of 39 trials, no trial reported interim analysis/stopping rules, subgroup analysis, dangers associated with multiplicity of analysis, interpretation of the results, taking into account sources of potential biases and any protocol deviations. More than 80% of the drug trials reported that the dose, frequency, route and duration of both the intervention and the control drug (Table 3). Table 3 also shows that less than 50% of the blinded trials reported who was blinded and few RCTs reported description of randomization, concealment of an allocation and use of intention to treat analysis.
No RCT reported who generated the allocation sequence and who enrolled participants. The success of blinding was not evaluated in all blinded trials. Ethical clearance was granted by an Ethics Review Committee was reported by 14 (36%) (15, 20–22, 24, 28, 37, 41–44, 49, 50, 52) of all trials and 7 (47%) (41–44, 49–51) of RCTs. It is reported that the consent was obtained by 16 (41%) (15, 16, 18–20, 22– 25, 35, 41, 42, 44, 49–51) studies.
Discussion Our study showed that the most striking feature of reporting quality was the lack of adherence to methodologically important items and underreporting of presentation of statistics. Items related to internal validity of RCTs such as randomization, concealment allocation, blinding and intention to treat analysis were reported in very few trials, which hampers the quality assessment of these trials. In our study, method of randomization and intention to treat analysis were reported only in 7% and 13% of trials, respectively, which were very lower than the percentage published by other studies (between 15% to 59% and 18% to 79%, respectively) (4, 54–58). One reason for less reporting could be due to the fact that we assessed the trials published since 1982, far before the CONSORT, where the others
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Table 3 Items reported in drug trials and randomized controlled trials in selected Sri Lankan journals [n (%)] All drug trials
Randomized controlled trial
Items reported
Yes
No
Yes
No
Intervention group – drug dose Intervention group – frequency of the drug Intervention group – route of the drug Intervention group – duration of the drug Control group – drug dose Control group – frequency of the drug Control group – route of drug Control group – duration of the drug Blinding was (or not) performed Blinded participants Blinded treatment providers Blinded assessors Method of generation of random sequence Any restrictions such as blocking/stratification Who generated the allocation sequence Who enrolled participants Methods used to implement the allocation concealment Use of intention-to-treat principle
33 (100) 32 (97) 32 (97) 31 (94) 23 (100) 22 (96) 21 (91) 21 (91) 13 (33) 05 (41.6) 03 (25) 03 (25)
00 (00) 01 (03) 01 (03) 02 (06) 00 (00) 01 (04) 02 (09) 02 (09) 26 (67) 07(58.4) 09 (75) 09 (75)
15 (100) 15 (100) 15 (100) 15 (100) 15 (100) 15 (100) 14 (93) 15 (100) 09 (60) 03 (33) 03 (33) 02 (22) 01 (7) 01 (7) 00 (0) 00 (0) 05 (33) 02 (13)
00 (00) 00 (00) 00 (00) 00 (00) 00 (00) 00 (00) 01 (07) 00 (00) 06 (40) 06 (67) 06 (67) 07 (78) 14 (93) 14 (93) 15 (100) 15 (100) 10 (67) 13 (86.6)
restricted their search strategies to databases and published in recent few years. One larger review on traditional Chinese RCTs published since 1978 reported that adequate method of randomization was 12% (56). In contract to that most of these studies assessed adequate description of method of randomization (55–57, 59) and intention to treat analysis (4, 54, 55, 59) where we assessed whether the reporting of a method of randomization and intention to treat analysis irrespective of the description was adequate or not. In our study, reporting of allocation concealment was 33%. In contrast to that, others (55, 56, 59) reported very low reporting of allocation concealment range in between 3% to 7% where they reported adequate description of allocation concealment. We couldn’t find any trial which described allocation concealment adequately. One study which searched trials published recently reported that it was 69% (57). According to our study, 33% of all trials and 60% of RCTs reported blinding status. However, as in other studies (55, 60), details of blinding were under reported. One study reported that it was 83% (57) and others lower than our study (4, 54, 55). Studies have shown that non-randomized trials and RCTs that do not incorporate blinding are overestimating the treatment effects (61, 62). In our study, reporting of the pre-study sample size calculation was 18% of all trials and 27% of RCTs. Our results were consistent with two other studies assessed RCTs reporting quality (54, 55). Another study reported that it was 77% (57). Reporting of confidence interval for effect measures was 10% for all trials and 20% for RCTs. Two studies (5, 55) assessed RCTs published in 2003 reported that
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use of confidence intervals was 36% (5) and 15%, respectively (55). Details that could be used to assess the external validity were present in 13% of all trials and 7% of RCTs in our study. Two studies assessed RCTs published in 2003 and 2004 reported that much higher values 100% (55) and 61% (54), respectively. In our study, flow diagram was included in 10% of trials. Several studies (54, 55, 59) showed that depiction of flow diagrams was less than 10% and others (4, 57) more than 10%. Trials of higher methodological quality were more likely to provide information about their ethical aspects (63, 64). According to our study approval of the protocol from an Ethics Review Committee and obtaining consent from the participants were 36% and 41% of all trials, respectively. Four studies (54, 59, 63, 64) showed that reporting of ERC approval and request for informed consent were much higher (70%-95%) than our study. Our study is the first one in Sri Lanka to evaluate the reporting quality of trials. This study has some limitations. We couldn’t assess the adequacy of the description of the items due to unavailability of reporting. As only 15 trial reports were RCTs, we could not compare between the trials published before and after the CONSORT, even though all the journals do not adopt the CONSORT. Previous studies showed that journals’ endorsement of CONSORT and its extensions seems to be associated with improvements in quality of reporting of RCTs (12, 55, 65, 66). Previous studies have also showed the importance of adhering to CONSORT statement and related extensions in the
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“Information for Authors” of medical journals for improving reporting of RCTs (54, 67, 68). One study showed that more than 60% of the authors who reported their studies in the principal cardiothoracic journals were not aware of it (55). Previous studies reported that the involvement of a trial methodologist (epidemiologist or biostatistician) improves reporting quality (69, 70). Further, some studies indicated that the reporting quality had somewhat improved over time (57, 71, 72) probably due to influence of CONSORT and its implementation. The quality of reporting non-randomized and randomized controlled trials published in Sri Lankan journals is suboptimal. We recommend that increase education and training in the designing and reporting of clinical trial methodology and biostatistics and the awareness of the CONSORT and TREND statements among the authors, peer-reviewers and editors may also help improve the quality of reporting.
Acknowledgements We would like to express our appreciation to Ms. M. P. L. R. Marasinghe, Assistant Librarian, Faculty of Medicine, University of Kelaniya, and Dr. T.I. Pathirana for retrieving some articles.
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