Evaluation of the reporting quality of clinical practice guidelines on prostate cancer using the RIGHT checklist
Original Article

Evaluation of the reporting quality of clinical practice guidelines on prostate cancer using the RIGHT checklist

Kefeng Liu1,2#, Yanfang Ma3#, Yongjie Yang1,2, Jingli Lu1,2, Jie Zhao1,2, Shuzhang Du1,2, Xuepei Zhang4, Chunlei Liu4, Francesco Del Giudice5, Masaki Shiota6, Shingo Hatakeyama7, Xiaojian Zhang1,2, Jian Kang1,2

1Department of Pharmacy, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, China; 2Henan Key Laboratory of Precision Clinical Pharmacy, Zhengzhou University, Zhengzhou, China; 3School of Chinese Medicine of Hong Kong Baptist University, Kowloon Tong, Hong Kong, China; 4Urology department, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, China; 5Department of Maternal-Infant and Urological Sciences, “Sapienza” University of Rome, Policlinico Umberto I Hospital, Rome, Italy; 6Department of Urology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan; 7Department of Urology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan

Contributions: (I) Conception and design: J Kang, K Liu; (II) Administrative support: J Zhao, X Zhang, S Du; (III) Provision of study materials or patients: Y Yang, J Lu; (IV) Collection and assembly of data: Y Ma, X Zhang, C Liu; (V) Data analysis and interpretation: K Liu, F Del Giudice, M Shiota, S Hatakeyama; (VI) Manuscript writing: All authors; (VII) Final approval of manuscript: All authors.

#These authors contributed equally to this work.

Correspondence to: Jian Kang. Department of Pharmacy, The First Affiliated Hospital of Zhengzhou University, No. 1 Jianshe East Road, Zhengzhou, China. Email: 2455232597@qq.com.

Background: The International Reporting Items for Practice Guidelines in Healthcare (RIGHT) statement is a set of recommendations for reporting in clinical practice guidelines (CPGs). We aimed to use RIGHT to evaluate the reporting quality of CPGs on prostate cancer.

Methods: We systematically searched literature databases and websites from January 1, 2018 to December 1, 2020 to identify CPGs on prostate cancer. Two investigators reviewed the identified articles and assessed the reporting quality independently by using the RIGHT checklist. We reported the proportions of guidelines that complied with each of the 35 RIGHT checklist item and the mean reporting compliance percentages for each of the seven domains of RIGHT.

Results: A total of 38 CPGs were included. The mean overall reporting rate over the included CPGs was 51.6%. Eighteen items were reported by more than half of the guidelines four items (1a 3, 7a and 13a) were reported by all guidelines. Items 7b (10.5%), 13b (10.5%), 14c (13.2%), and 18b (7.9%) had the lowest reporting proportions. The mean reporting rates in each RIGHT domain were 74.6% for “Basic Information”, 26.3% for “Review and quality assurance”, 59.9% for “Background”, 43.7% for “Evidence”, 43.2% for “Recommendations”, 43.4% for “Funding and declaration and management of interests”, and 43.0% for “Other information”.

Conclusions: The overall adherence of CPGs on prostate cancer to RIGHT checklist is poor. Following the RIGHT checklist during the development of the guideline could improve the quality of reporting in the future.

Keywords: Prostate cancer; clinical practice guidelines (CPGs); Reporting Items for Practice Guidelines in Healthcare (RIGHT); quality

Submitted Mar 16, 2021. Accepted for publication Jun 24, 2021.

doi: 10.21037/atm-21-2956

Introduction

Prostate cancer is the most commonly diagnosed cancer among males across the word (1). The Global Cancer Observatory estimated that there were nearly 1.3 million new cases of prostate cancer and 360,000 prostate cancer related deaths in 2018 worldwide. Prostate cancer is expected to become the most common type of cancer by 2030, with one in eight men expected to be diagnosed with prostate cancer during their lifetime (2). Despite the fact that prostate cancer is the second leading cause of cancer-related death in males, survival rates have greatly improved over the past four decades with the earlier diagnosis through Prostate-Specific Antigen (PSA) testing and new treatments. The prostate cancer incidence rates declined approximately 6.5% per year from 2007 and after years of significant decline (from 1993 to 2013), the overall prostate cancer mortality trend stabilized in recent years (3,4).

Clinical practice guidelines (CPGs) are important means of guiding medical personnel to make decisions based on the latest scientific evidence (5). In recent years, an increasing amount of academic organizations and institutions have developed CPGs related to prostate cancer (6). Clear and transparent reporting is an important factor that can facilitate effective dissemination and implementation of the guidelines (7). The reporting quality of CPGs in many fields has been shown to be heterogeneous (8).

Reporting Items for Practice Guidelines in Healthcare (RIGHT) (9) is a checklist that aims to assure a high quality of reporting. RIGHT is endorsed by the World Health Organization (WHO) in its guideline development manual. This study aims to evaluate the reporting quality of CPGs for prostate cancer using the RIGHT tool.

Methods

Literature search

We systematically searched Medline (via PubMed), Wanfang, China Biology Medicine (CBM) and China Knowledge Network (CNKI) databases, and the websites of the World Health Organization (WHO, https://www.who.int/publications/guidelines/year/en/), The National Institute for Health and Care Excellence (NICE, https://www.nice.org.uk/), National Comprehensive Cancer Network (NCCN, https://www.nccn.org/), Scottish Intercollegiate Guidelines The Scottish Intercollegiate Guidelines Network (SIGN, https://www.sign.ac.uk/our-guidelines/), Guidelines International Network (GIN, https://guidelines.ebmportal.com/), to identify all published CPGs on prostate cancer. The search time was limited to the time period from January 1, 2018 to December 1, 2020. The main search terms were “Prostatic Neoplasm”, “Prostate Cancer”, “Prostatic Cancer”, “Prostatic tumor” and “Prostate tumor”.

Inclusion and exclusion criteria

Two investigators (KF Liu and YF Ma) screened all titles and abstracts of the retrieved records to identify potentially relevant studies. In the next step, the full texts of the selected articles were screened by two investigators independently to decide about inclusion. Disagreements were resolved through discussion or by consulting a senior investigator (YJ Yang). Articles were included if they met the following inclusion criteria: (I) the article was a CPG on testing, diagnosis, treatment, or management of prostate cancer; and (II) the language of publication was Chinese or English. We excluded translations, summaries and interpretations of guidelines, as well as draft or unpublished guidelines.

Data extraction

We designed a data extraction table based on the RIGHT checklist, and the two trained investigators extracted the information from the included guidelines independently. Disagreements were solved by discussion. We extracted the basic information of the included guidelines, including the title, publication year, country or region of development, topic, developer agency, system used to grade the quality of evidence, the impact factor (IF) of the journal, and the funding source.

Reporting quality assessment using the RIGHT checklist

The RIGHT checklist consists of 35 items, which grouped into seven domains: basic information, background, evidence, recommendations, review and quality assurance, financial support and declaration and management of conflicts of interests, and other information. Each item was evaluated by both reviewers (KF Liu and YF Ma) independently as either “reported” (relevant information was sufficiently reported) or "not reported" (some relevant information was lacking). If an item did not apply for a specific guideline, we rated it as “not applicable”. Before the formal evaluation, two reviewers were trained to use the RIGHT tool, and two rounds of pre-tests were completed to ensure that the reviewers understood each item consistently. Disagreements were resolved through consensus or consulting with a third reviewer (YJ Yang).

Statistical analysis

We calculated the number and percentage of guidelines reporting each item, and conversely the percentage of items reported by each guideline. We also present the mean proportions of reported items for each RIGHT domain and overall. We also present the mean overall reporting rates stratified by the year of publication, language, type of developer organization, country or region of origin, and reporting of funding.

Results

Identification of guidelines

Our initial search retrieved 421 records, including 339 in English and 82 in Chinese. After screening the titles and abstracts, and the full texts of articles deemed potentially eligible, 38 articles were included into this study. The screening process and results are presented in Figure 1.

Figure 1 Flow chart of the literature review.

Characteristics of selected guidelines

Table 1 shows the basic characteristics of the included articles. Twelve guidelines were published in 2018, 13 in 2019 and 13 in 2020. Thirty-seven were published in English and one in Chinese. The included guidelines addressed the diagnosis, treatment and management of prostate cancer. Two guidelines were developed in China, twelve in the United States, seven by European multinational collaborations, four in the United Kingdom, three in France, two in Spain, two in Canada, two in Australia and New Zealand, one in Egypt, one in South Africa, one in Saudi Arabia and one by a multinational collaboration from Latin America. Eighteen guidelines were supported by government or institutional funds, and twenty did not report their funding sources.

Table 1
Table 1 Characteristics of the eligible CPGs
Full table

Overall analysis of reporting quality

The mean reporting rate of all 35 RIGHT checklist items in the included guidelines was 51.6%. Eighteen items were reported by more than half of the guidelines Items 1a, 3, 7a and 13a were reported by all guidelines (Table 2). Items 7b (reporting rate 10.5%), 13b (10.5%), 14c (13.2%), and 18b (7.9%), had the lowest reporting rates. Among the domains of the RIGHT checklist, “Basic Information” had the highest mean reporting rate (74.6%), and “Review and quality assurance” the lowest rate (26.3%). The mean reporting rates in the remaining domains were 59.9% for “Background”, 43.7% for “Evidence”, 43.25 for “Recommendations”, 43.4% for “Funding and declaration and management of interests”, and 43.0% for “Other information” (Figure 2).

Table 2
Table 2 The reporting rates of each RIGHT checklist item in the eligible clinical practice guidelines (9)
Full table
Figure 2 The mean reporting proportions of the RIGHT checklist domains in the included CPGs. RIGHT, Reporting Items for Practice Guidelines in Healthcare; CPGs, clinical practice guidelines.

Stratified analyses of reporting quality

The mean overall reporting proportion improved slightly over time, being 53.6% in guidelines published in 2018, 43.5% in 2019, and 57.6% in 2020 (Table 3). Guidelines published in Chinese had a reporting rate of 40.0%; for guidelines published in English the reporting rate was 51.8%. Guidelines that reported their funding sources had a higher reporting rate (60.9%) than those that either did not report funding, or reported receiving no funding (42.1%).

Table 3
Table 3 The reporting proportions of included CPGs in the stratified analyses
Full table

Discussion

This study evaluated the reporting quality of 38 CPGs for prostate cancer using the RIGHT checklist. The mean overall compliance to the items of RIGHT was 51.6%. Twenty-two of the 38 guidelines adhered to less than half of the items. Items related to basic information and background were relatively well reported, whereas the compliance with items related to the review and quality assurance was poor. In particular the description of patient groups that need special consideration and the role of the funders were extremely rarely reported.

The domains for basic information and background had a relatively high reporting rate across all guidelines. However, the publication year and a summary of the recommendations tended to be poorly reported. Of the top 50% of guidelines ranked by overall reporting proportions, only four reported the year of publication in the title, and 74% of them did not have a summary. Most guidelines included in our review had deficiencies in reporting the review and quality assurance process. Items pertaining to external review, peer reviewers, review process and management of the feedback were poorly reported.

Guidelines with funding support had a higher overall reporting quality than those not declaring or having funding. Funding is of great importance, because the development, maintenance, effective dissemination and implementation of guidelines is an expensive and labor-intensive endeavor (48). CPG panels with financial support may confer quality benefits. However, few guidelines reported the sources of funding for the different stages of the development, dissemination and implementation of the guideline and recommendations in detail. The results suggest a need for greater transparency and rigor in the role of funders.

We found several factors correlated with the reporting quality of guidelines. First, the reporting quality tended to be higher in journals with a high IF, which could reflect more rigorous editorial policies and peer review. Second, high reporting integrity was found, as expected, in guidelines that have targeted and sufficient funding. Guideline development is expensive and time consuming, so adequate funding or resources can promote guideline quality (49). Third, guidelines that use a grading system of evidence, such as GRADE, tended to comply better with RIGHT. The use of a grading system may reflect a high level of methodological experience or knowledge, or attending specific training in guideline methodology, by the development team.

To our knowledge, our study is the first time that the RIGHT checklist were used to evaluate the reporting quality of clinical practice guidelines on prostate cancer. However, we also has several limitations. The included CPGs were heterogeneous in many aspects, which may explain the observed differences in reporting integrity. The stratified presentation of the reporting quality does not capture the impact of all factors and the interactions between them. We only included guidelines published in Chinese and English.

Questions to be further discussed and considered

Question 1: What impact do you think the low reporting quality of clinical practice guidelines on prostate cancer will have on clinicians and clinical practices?

Expert opinion: Dr. Francesco Del Giudice

Prostate Cancer Guidelines have a terrific impact on the clinical practice of thousands of urologists worldwide. The diagnostic and therapeutic choices of many practitioners is definitively and strongly influenced form the Guidelines therefore an overall low quality of these Guidelines might generate confusion and disorientation in the clinical daily practice.

Expert opinion: Dr. Masaki Shiota

Clinical practice guidelines are expected to be used by clinicians in clinical practice to help improve the quality of care and avoid unnecessary care. Low quality reporting of clinical practice guidelines can lead to various problems. First, it may hinder the dissemination of clinical practice guidelines because they do not gain the trust from clinicians. In addition, inadequate content may lead to inappropriate medical care. Finally, low reporting quality of clinical practice guidelines on prostate cancer may prevent improvements of disease understanding, quality of care, patient outcomes, and efficient medical care.

Expert opinion: Dr. Shingo Hatakeyama

It is no doubt that the low reporting quality of clinical practice guidelines on prostate cancer has a great impact on clinical practice.

However, the meaning of “low quality” needs further discussion.

If the “low quality” means “old evidence”, it needs revision as soon as possible. However, a very rapid paradigm shift based on many Phase III RCT makes it difficult to change clinical practice guidelines quickly. We realized that the updated clinical practice guideline of 2020 become the “old one” in 2021. Although the update is necessary, update every year is not easy task.

If the “low quality” means “low compliance to evidence”, it is not suitable for a clinical practice guideline. The experience-based recommendation needs to revise to the robust evidence from Phase III RCT. However, medical situation (such as insurance system, cost, etc.) needs to take this into account in each country.

If the “low quality” means “too many conflicts of interest”, it is a difficult situation. Statement of COI needs to open.

Question 2: What impact does the low reporting quality of clinical practice guidelines on prostate cancer have on clinicians and clinical practices?

Expert opinion: Dr. Francesco Del Giudice

Increasing the Quality level of PCa Guidelines can be obtained by: (I) adoption and clinical utilization of practical diagnostic and therapeutic algorithms; (II) more clarity in the level of recommendation for each single item not only in terms of Level of Evidence but also (and importantly) on the Level of Adoption in daily practice; (III) greater amount of cost/benefits analysis.

Expert opinion: Dr. Masaki Shiota

The purpose of the RIGHT checklist is to assist guideline development. Similarly, the Appraisal of Guidelines for Research & Evaluation II (AGREE II) is another tool that was developed to assess the rigor and transparency of methods in the guideline development process. Therefore, the use of RIGHT checklists and AGREE II will enable the development of high-quality guidelines for clinical practice guidelines on prostate cancer.

Expert opinion: Dr. Shingo Hatakeyama

The answer is simple. We need to update it every year! But hard task for us.

Question 3: How do you think conflicts of interest in the guidelines should be handled?

Expert opinion: Dr. Francesco Del Giudice

All conflicts of interest of each single Guideline panel member should be highlighted at the beginning of the guidelines specifying accurately the relationship between the scientific societies and the commercial companies enrolled in the products (pharmaceuticals, surgical devices etc.) that take place in the everyday clinical management of PCa.

Expert opinion: Dr. Masaki Shiota

Appropriate reporting of financial and non-financial interests and their implications in guideline development is important for transparent and high-quality guidelines. Therefore, the development needs to address these concerns. Therefore, it is necessary to describe the potential financial and non-financial conflicts of interest of guideline authors. As well, it should clearly state how conflicts of interest were assessed and managed.

Expert opinion: Dr. Shingo Hatakeyama

We could not avoid the influence of COI. We need to open COIs.

Conclusions

The overall adherence of CPGs on prostate cancer to RIGHT checklist is poor. The reporting of some aspects, such as quality assurance, executive summary, subgroups, funding sources and the role of the funder, need particular attention. Developers of prostate cancer CPGs are advised to improve the completeness of reporting and take advantage of tools such as the RIGHT checklist to promote the dissemination and implementation of their guidelines.

Acknowledgments

The authors appreciate the academic support from the AME Reporting Guideline Collaborative Group.

Funding: None.

Footnote

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://dx.doi.org/10.21037/atm-21-2956). MS received research funding support from Daiichi Sankyo Company, Ltd., and honoraria from Janssen Pharmaceutical K.K., AstraZeneca K.K., and Astellas Pharma Inc. The other authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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Cite this article as: Liu K, Ma Y, Yang Y, Lu J, Zhao J, Du S, Zhang X, Liu C, Del Giudice F, Shiota M, Hatakeyama S, Zhang X, Kang J. Evaluation of the reporting quality of clinical practice guidelines on prostate cancer using the RIGHT checklist. Ann Transl Med 2021;9(14):1173. doi: 10.21037/atm-21-2956

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