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 Table of Contents  
ORIGINAL ARTICLE
Year : 2013  |  Volume : 2  |  Issue : 2  |  Page : 93-102

Reporting of randomized controlled trials: A systematic review and bibliometric analysis of quality and quantity of publications in palliative care journals


1 Department of Physiotherapy, Kasturba Medical College (Manipal University), Mangalore, India
2 Department of Physiotherapy, Srinivas College of Physiotherapy, Pandeshwar, Mangalore, India

Date of Web Publication10-Sep-2013

Correspondence Address:
Senthil P Kumar
Department of Physiotherapy, Kasturba Medical College, Manipal University, Mangalore - 575 001
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2278-0521.117913

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  Abstract 

Background: This study aimed to perform a bibliometric analysis of Randomized Controlled trials (RCTs) published in palliative care journals. Settings and Design: Systematic review of palliative care journals. Materials and Methods: MEDLINE database was searched for journals with name 'palliative' in their title, and articles published from January 2007 - December 2011 were then searched in individual journals with search limits activated for 'randomized controlled trials.' The reporting rates of all journals were compared. The selected articles were categorized into practice, education, research, and administration (PERA). The articles were also grouped under participants, interventions, comparisons, and outcomes (PICO) format for analysis. Quality scoring of RCTs was done using Jadad scale. Statistical Analysis: Quality scores were compared between journals and article categories (PERA, PICO) using one-way ANOVA with Bonferonni test, Chi-square test were done at 95% confidence interval using SPSS for Windows version 16.0. Results: The overall reporting rate of RCTs in palliative care journals was 1.04%, and the overall RCTs' quality score was 2.8.99 out of a total score of 5 on Jadad scale. PSC had the highest reporting rate of 3.27% (8/244) followed by JPC at 1.53% (3/196) and PM at 1.353% (8/591). The RCTs in IJPN had the highest quality score at 3, followed by AJHPC (3 ± 1) and JPPCP (3 ± 2.82). Significant association was found between cancer patients as study population and practice as RCT category. Comparison between PERA and PICO categories for quality of RCTs was not significant (P > 0.05). Conclusions: The 12 palliative care journals analyzed in this study published few RCTs at a five-year reporting rate of 1.04%, with Palliat Support Care having the highest reporting rate. Overall quality of the RCTs was moderate-low category.

Keywords: Evidence-based palliative care, hierarchy of evidence, journal reporting, publication trend, research trend


How to cite this article:
Kumar SP, Sisodia V. Reporting of randomized controlled trials: A systematic review and bibliometric analysis of quality and quantity of publications in palliative care journals. Saudi J Health Sci 2013;2:93-102

How to cite this URL:
Kumar SP, Sisodia V. Reporting of randomized controlled trials: A systematic review and bibliometric analysis of quality and quantity of publications in palliative care journals. Saudi J Health Sci [serial online] 2013 [cited 2019 Jul 21];2:93-102. Available from: http://www.saudijhealthsci.org/text.asp?2013/2/2/93/117913


  Introduction Top


Randomized controlled trial (RCT) is a study in which participants are randomly (i.e. by chance) assigned to one of two or more treatment arms of a clinical trial. [1] The first RCT on palliative care in MEDLINE was the study done by Wolfer and Visintainer [2] on pediatric surgical patients and parents' stress responses and the role of nursing care on psychological preparation and ever since then, there has been a steady increase in number of RCTs in all fields of care.

The evolution of evidence-based practice in healthcare paved way for the RCTs and systematic reviews to be the highest among levels of evidence to guide therapeutic decisions in palliative care. Such care decisions are often arrived upon a thorough critical appraisal of RCTs. [3] The evaluation of the methodological quality of randomized controlled trials (RCTs) is central to evidence-based health care. Important methodological details may, however, be omitted from published reports, and the quality of reporting is, therefore, often used as a proxy measure for methodological quality. [4] Quality of reporting is often interpreted using standardized checklists such as the CONSORT statement, and methodological quality is assessed using quality scores into low, moderate, or high. However, this inter-relationship between quality of reporting and methodological quality determines the critical appraisal and interpretation both as a practicing clinician in evidence-based practice, or by a researcher for including such studies in systematic reviews and meta-analyzes. [5]

Previous studies on randomized clinical trials were reported in the fields of anesthesiology, [6] cardio-thoracic surgery, [7] complementary and alternative medicine, [8] dermatology, [9] emergency medicine, [10] endocrinology, [11] psychiatry, [12] medical journals, [13] nephrology, [14] neurosurgery, [15] obstetrics and gynecology, [16] oncology, [17],[18] ophthalmology, [19] orthodontics, [20] orthopedics, [21] otorhinolaryngology, [22] pediatrics, [23] periodontology, [24] pharmacology, [25] pharmacy, [26] psychiatry, [27] public health, [28] non-pharmacological therapy, [29] and traditional Chinese medicine. [30]

Previous studies on review of RCTs' quality and quantity in areas related to palliative care were on cancer patients' understanding of RCTs, [31] cancer patients' perception of quality of informed consent, [32] general cancer, [33] breast cancer, [34] brain tumor, [35] lung cancer, [36],[37],[38] solid tumors, [39] sarcomas, [40] Hodgkin lymphoma, [41] and cancer survival end-point reporting. [42]

Although many studies on analysis of RCTs related to cancer were published earlier, they were in other specialties such as oncological and cancer journals and not in palliative care journals per se. Evaluation of palliative care journals would not only provide us with the information on the existing evidence base of RCTs in the journals, but also may pave way towards better reporting and improved conduct of RCTs in the field of palliative care. Hence, there is a need to evaluate the reporting characteristics of randomized trials so that future research could be designed in studies on dying patients. [43]

Previously published studies on analysis of palliative care journals were on reporting of moral problems (ethical issues), [44] euthanasia, [45] chaplains and community-based clergy, [46] and, religion and spirituality, [47] cancer pain, [48] and pediatric palliative care. [49] Since such a quantitative and qualitative analysis of RCTs was not previously performed in palliative care journals, the objective of this study was to perform a systematic review of reporting randomized trials in palliative care journals.


  Materials and Methods Top


Search strategy and criteria

MEDLINE database was searched for journals with name 'palliative' in their title, and articles published from January 2007-December 2011 were then searched in individual journals using search limits activated for 'randomized controlled trial.' The search strategy used in this study was earlier described by Jadad and McQuay [50] to have had a search sensitivity of 87%.

Data synthesis

The total number of articles in all the selected journals was taken as N. The number of included articles (N 1 ) based on search criteria were compared with total number of published articles (N) to obtain reporting rates (N 1 /N%) for each journal.

The journals were categorized broadly into multidisciplinary, medical, nursing, and other (social work) categories of palliative care journals. The number of RCTs published in proportion to the total number of articles published during the search period was calculated as the reporting rate for each journal. On the first level, the obtained articles were classified according to PERA model of practice, education, research, and administration. Since the included studies were RCTs and their critical appraisal during interpretation for evidence-based practice includes PICO (participants, interventions, comparisons, and outcomes) model, the four categories were sub-categorized subsequently. Participants or study population- heterogeneous (general or mixed) and homogeneous (patients as cancer and non-cancer; normal healthy subjects; and, healthcare professionals); Interventions- medical, surgical, complementary and alternative therapies, psychosocial methods and multidisciplinary treatments; Comparisons- control (no treatment), sham or placebo, similar treatments, standard care and combined interventions; Outcomes-subjective (patient-reported), objective (clinician-rated or measured), and mixed (both subjective and objective).

Data analysis

The reporting rates were compared between journals using Friedman's test. Categorical association between PERA and PICO types was done using Chi-square test. The quality scores were computed in means and standard deviations, which were compared between journals and PERA/PICO categories using one-way analysis of variance and post-hoc analysis using Bonferonni test. All analyzes were done at 95% confidence interval using SPSS version 16 for Windows (SPSS Inc, Chicago, IL).


  Results Top


There were a total of 40, 10, 635 citations in PubMed, and of them, 86,847 were RCTs. The retrieved RCTs from palliative care journals were 52, and a final list of included RCTs was 42. Ten citations were excluded since 5 were not RCTs, 4 were secondary findings of RCTs, and 1 was about an RCT.

Overall reporting rate of RCTs in all palliative care journals combined was 1.05% (42/4000). The 42 RCTs included 3 RCTs in AJHPC, 2 RCTs in IJPN, 3 in JPC, 16 in JPM, 2 in JPPCP, 8 in PM, and 8 in PSC. Of the 12 journals, PSC had the highest reporting rate of 3.27% (8/244) followed by JPC at 1.53% (3/196) and PM at 1.353% (8/591). Medical palliative care journals had the highest reporting rate at 1.24% (18/1449), followed by multidisciplinary journals at 0.67% (14/2087) and nursing journals at 0.43% (2/464). [Table 1] provides the comparison of palliative care journals on their reporting of RCTs, and [Figure 1] depicts the relative contribution from each journal.
Figure 1: Relative contribution of palliative care journals on number of included RCTs

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Table 1: Comparison of reporting rates of randomized controlled trials between palliative care journals

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On PERA analysis [Figure 2], there were 31 RCTs on practice, [5],[6],[7],[8],[9],[10],[11],[12],[13],[14],[15],[16],[17],[18],[19],[20],[21],[22],[23],[24],[25],[26],[27],[28],[29],[30],[31],[32],[33],[34],[35],[36],[37],[38],[39],[40],[41],[42],[43],[44],[45],[46],[47],[48],[49],[50],[51],[52],[53],[54],[55],[56],[57],[58],[59],[60],[61],[62],[63],[64],[65],[66],[67],[68],[69],[70],[71],[72],[73],[74],[75],[76],[77],[78],[79],[80],[81] 6 RCTs on education, [82],[83],[84],[85],[86],[87] no RCTs on research, and 5 RCTs on administration. [88],[89],[90],[91],[92] [Figure 3] shows the comparison of journals for their reporting on PERA categories. On PICO analysis, the sample populations included [Figure 4]: General (heterogeneous) population, [53],[55],[56],[58],[62],[66],[74],[80],[84],[87],[88],[89] cancer, [51],[52],[55],[57],[6],[064],[68],[69],[73],[74],[75],[77],[78],[79],[80],[81] non-cancer, [56],[89],[67] healthy subjects, [62],[90] and healthcare providers; [70],[71],[82],[83],[85],[86],[88],[92] interventions included [Figure 5]: Medical, [51],[52],[57],[60],[62],[63],[64],[65],[66],[67],[68],[69],[73] surgical, [79] complementary and alternative treatments, [54],[59],[72],[77] psychosocial methods, [53],[55],[56],[58],[61],[67],[7],[071],[74],[75],[76],[77],[78],[81],[82],[83],[84],[85],[86],[87],[88],[89],[90],[92] and multidisciplinary interventions; [80],[91] the comparison treatments were [Figure 6]: No-intervention controls, [53],[55],[59],[71],[77],[85],[86],[87],[88] sham or placebo, [57],[62],[63],[68],[69],[72] standard care, [52],[67],[70],[73],[75],[ 78],[79],[80],[83],[86],[56],[61],[91],[92] similar treatment [51],[64],[60],[64],[65],[66],[74],[81],[92] and combined interventions; [58],[76],[82],[89] and, the outcomes were [Figure 7]: subjective, [54],[55],[56],[57],[58],[61],[63],[64],[67],[68],[70],[71],[72],[73],[74],[75],[76],[77],[78],[79],[80],[81],[82],[83],[84],[89],[90] objective, [59],[66],[69],[88] and mixed. [51],[52],[53],[60],[62],[65],[85],[87],[91] Association between the PERA categories and PICO types in the included RCTs is shown in [Table 2].
Figure 2: Relative proportion of number of RCTs on practice, education and administration

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Figure 3: Relative representation of RCTs on practice, education and administration between palliative care journals

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Figure 4: Relative proportion of number of RCTs on different categories of study populations

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Figure 5: Relative proportion of number of RCTs on different categories of interventions

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Figure 6: Relative proportion of number of RCTs on different categories of comparison groups

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Figure 7: Relative proportion of number of RCTs on different categories of outcome measures

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Table 2: Association between PERA categories and PICO types in the included RCTs

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Quality assessment and scoring for RCT

[Figure 8] shows the overall item-wise responses for the Jadad scale for all the included RCTs. The item-wise responses for quality scoring of RCTs on practice, education, and administration are provided in [Table 3], [Table 4] and [Table 5]. The quality score of RCTs on practice (2.9 ± 1.07) was more than that of administration (2.6 ± 0.54) and education (2.5 ± 0.83), which was not statistically significant (P = 0.594, F = 0.528). The comparison of RCTs' quality scores between practice, education, and administration categories is shown in [Figure 9]. The RCTs in IJPN had the highest quality score at 3, followed by AJHPC (3 ± 1) and JPPCP (3 ± 2.82). Between-journal comparison was not statistically significant (P = 0.986, F = 0.157). The comparison of RCTs' quality scores between the palliative care journals is shown in [Figure 10]. [93],[94]
Figure 8: Responses to quality evaluation of the RCTs using Jadad scale

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Figure 9: Comparison of quality scores of RCTs between practice, education and administration

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Figure 10: Comparison of quality scores of RCTs between palliative care journals

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Table 3: Quality assessment and scoring of RCTs on practice in palliative care journals using the Jadad scale

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Table 4: Quality assessment and scoring of RCTs on education in palliative care journals using the Jadad scale

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Table 5: Quality assessment and scoring of RCTs on administration in palliative care journals using the Jadad scale

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  Discussion Top


Of the 4011792 citations in PubMed during the same search period, there were a total 1, 67, 408 citations indexed as 'clinical trial' in PubMed, and 87,011 were listed as 'randomized controlled trials' (a reporting rate of 2.16%). Considering that palliative care journals publish only a very minor percentage of RCTs at. 0048%, there is still a lot of scope for further improving the amount of reporting RCTs.

This study had some interesting observations: There were no RCTs reported in pediatric population, which was in accordance with the findings of Cohen et al.[95],[96] that adult RCT publications increased at a rate of more than five times when compared to pediatric RCTs. Intention-to-treat (ITT) is an approach to the analysis of randomized controlled trials (RCT), in which patients are analyzed as randomized regardless of the treatment actually received. Although most of the RCTs had missing data and patient drop-outs, very few RCTs included statistical analyzes based upon intention-to-treat (ITT) principle, [97] and accurate reporting and appropriate methodological conduct of RCTs should be done based upon ITT. [98] RCTs on research were absent, which warrant that more and more RCTs on modification of patients' perceptions and willingness [99] through educational interventions [100] targeted on understanding and attitudes [101] to participate in research are needed so as to overcome the potential barriers and methodological challenges [102] to trial participation and consent. Clinical trials in palliative care are more likely to be successful if developed in accordance with the views of patients and their relatives [103],[104] and palliative healthcare professionals. [105]

With newer measurement methods being developed and reported to estimate treatment effects in randomized trials such as "years-needed-to-treat," [106] palliative care would evidently benefit from the evidence-base provided by high-quality RCTs, which are more of multi-centric, pragmatic following robust reporting guidelines such as the CONSORT statement. [107],[108],[109] It would be interesting to analyze the quality of reporting RCTs before and after the CONSORT 2010 statement, [110] as it was found earlier for the earlier version of CONSORT statement by Moher et al. [111]

The generalizability of findings from RCTs is questionable since RCT patients and treatments are not typical of those in clinical practice, and most patients in clinical practice are receiving treatments that do not have direct empirical support. [112]

One of the acceptable limitations of this study was that it included journals from MEDLINE through PubMed, since it was the most common and most widely searched database and is freely accessible. Previous reports of quality of reporting in RCTs were done only in PubMed. [113]

American society of clinical oncology [114] had released a policy statement on clinical research, which is applicable for researchers planning to perform RCTs, that includes as follows:

  1. Ensure safety precautions for clinical trial participants and their fully informed consent
  2. Ensure the validity and integrity of scientific research
  3. Enhance the educational training of clinical scientists and research staff to ensure the highest standards of research conduct.
  4. Promote accountability and responsibility among all those involved in clinical research (not just those serving on institutional review boards [IRBs], but also institutional officials, researchers, sponsors, and participants) and ensure support for an effective oversight process
  5. Enhance the professional and public understanding of clinical research oversight
  6. Enhance the efficiency and cost-effectiveness of the clinical research oversight system.
Three arguments to justify the need for effectiveness research in palliative care should be highlighted: [115]

  1. There is evidence of an untapped altruism amongst the population of palliative care patients who would be keen to be involved in such research
  2. Traditional Aristotelean and Thomistic virtue ethics would point to the need to gain knowledge in and of itself, but especially in palliative medicine for the benefit of PATIENTS: Virtue also accrues in the acquisition of a stock of research experience, which in turn makes further research feasible
  3. Most compellingly, justice would dictate that palliative treatments are effective, that futile or useless treatments are avoided and that patients are not party to "n of 1" trials by default.

  Conclusion Top


The overall reporting rate of RCTs in palliative care journals was 1.04%, and the overall RCTs' quality score was 2.8.99 out of a total score of 5 on Jadad scale. PSC had the highest reporting rate of 3.27% (8/244), followed by JPC at 1.53% (3/196) and PM at 1.353% (8/591). The RCTs in IJPN had the highest quality score at 3, followed by AJHPC (3 ± 1) and JPPCP (3 ± 2.82).

 
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