scholarly journals Critical Evaluation of Oncology Clinical Practice Guidelines

2013 ◽  
Vol 31 (20) ◽  
pp. 2563-2568 ◽  
Author(s):  
Bradley N. Reames ◽  
Robert W. Krell ◽  
Sarah N. Ponto ◽  
Sandra L. Wong
Keyword(s):  
Clinical Practice ◽  
Clinical Practice Guidelines ◽  
Practice Guidelines ◽  
Public Involvement ◽  
Conflicts Of Interest ◽  
Critical Evaluation ◽  
The United States ◽  
Patient And Public Involvement ◽  
Institute Of Medicine ◽  
Consensus Statements

Purpose Significant concerns exist regarding the content and reliability of oncology clinical practice guidelines (CPGs). The Institute of Medicine (IOM) report “Clinical Practice Guidelines We Can Trust” established standards for developing trustworthy CPGs. By using these standards as a benchmark, we sought to evaluate recent oncology guidelines. Methods CPGs and consensus statements addressing the screening, evaluation, or management of the four leading causes of cancer-related mortality in the United States (lung, breast, prostate, and colorectal cancers) published between January 2005 and December 2010 were identified. A standardized scoring system based on the eight IOM standards was used to critically evaluate the methodology, content, and disclosure policies of CPGs. All CPGs were given two scores; points were awarded for eight standards and 20 subcriteria. Results No CPG fully met all the IOM standards. The average overall scores were 2.75 of 8 possible standards and 8.24 of 20 possible subcriteria. Less than half the CPGs were based on a systematic review. Only half the CPG panels addressed conflicts of interest. Most did not comply with standards for inclusion of patient and public involvement in the development or review process, nor did they specify their process for updating. CPGs were most consistent with IOM standards for transparency, articulation of recommendations, and use of external review. Conclusion The vast majority of oncology CPGs fail to meet the IOM standards for trustworthy guidelines. On the basis of these results, there is still much to be done to make guidelines as methodologically sound and evidence-based as possible.

A critical evaluation of oncology clinical practice guidelines.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 6020-6020
Author(s):  
Bradley Norman Reames ◽  
Robert Wallace Krell ◽  
Sarah Nicks Ponto ◽  
Sandra L. Wong
Keyword(s):  
Clinical Practice ◽  
Clinical Practice Guidelines ◽  
Practice Guidelines ◽  
Public Involvement ◽  
Conflicts Of Interest ◽  
Critical Evaluation ◽  
Small Cell ◽  
Small Cell Lung ◽  
Consensus Statements ◽  
The Us

6020 Background: Clinical Practice Guidelines (CPGs) play an essential role in cancer care today, but there are significant concerns regarding their content and reliability. In 2011, the Institute of Medicine (IOM) report “Clinical Practice Guidelines We Can Trust” created standards for developing trustworthy CPGs. Using these standards as a benchmark, we sought to evaluate recent oncology guidelines. Methods: CPGs and consensus statements addressing the screening, evaluation or management of the four leading causes of cancer-related mortality in the US (non-small cell lung, breast, prostate and colorectal cancers) published between January 2005 and December 2010 were identified using MEDLINE. A standardized scoring system based on the eight standards set forth by the IOM was devised, and the methodology, content and disclosure policies of CPGs were critically evaluated by four independent reviewers. All CPGs were given two scores; points were awarded out of a possible 8 major criteria and 20 sub-criteria. Results: We identified 168 CPGs for inclusion in the study; 45% were from US groups. None of the CPGs fully met all the IOM standards. On average, CPGs only met 2.8 of 8 standards set forth by the IOM (mean 2.8 points out of 8, SD 1.7; 8.3 out of 20, SD 4.3). Less than half of CPGs were based on a systematic review. Only half of CPG panels addressed conflicts of interest. Overall, the CPGs were most consistent with IOM standards for transparency regarding the development process, articulation of recommendations, and use of external review. Most did not comply with standards for inclusion of patient and public involvement in the development or review process, nor did they specify their process for updating. CPGs from the US had higher overall scores than CPGs from international groups. CPGs addressing non-small cell lung cancer had higher overall scores (mean 3.9) than those for other cancers. Conclusions: The vast majority of oncology CPGs fails to meet the IOM standards for trustworthy guidelines. Notably, most CPGs are not based on systematic reviews, lack full disclosure, and do not include all relevant stakeholders in the guideline process. This highlights the need for improved CPG development processes.

Patient and Public Involvement in Clinical Practice Guidelines

2011 ◽  
Vol 31 (6) ◽  
pp. E45-E74 ◽  
Author(s):  
France Légaré ◽  
Antoine Boivin ◽  
Trudy van der Weijden ◽  
Christine Pakenham ◽  
Jako Burgers ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Literature Review ◽  
Clinical Practice Guidelines ◽  
Practice Guidelines ◽  
Public Involvement ◽  
The United States ◽  
Patient And Public Involvement ◽  
Bibliographic Databases ◽  
The Public ◽  
The Impact

Background. The role of patient and public involvement programs (PPIPs) in developing and implementing clinical practice guidelines (CPGs) has generated great interest. Purpose. The authors sought to identify key components of PPIPs used in developing and implementing CPGs. Data sources. The authors searched bibliographic databases and contacted relevant organizations. Study selection. In total, 2161 articles and reports were retrieved on PPIPs in the development and implementation of CPGs. Of these, 71 qualified for inclusion in the review. Data extraction. Reviewers independently extracted data on key components of PPIPs and barriers and facilitators to their operation. Data synthesis. Over half of the studies were published after 2002, and more than half originated from the United States, the United Kingdom, Australia, and Germany. CPGs that involved patients and the public addressed a variety of health problems, especially mental health and cancer. The most frequently cited objective for using PPIPs in developing CPGs was to incorporate patients’ values or perspectives in CPG recommendations. Patients and their families and caregivers were the parties most often involved. Methods used to recruit PPIP participants included soliciting through patient/public organizations, sending invitations, and receiving referrals and recruits from clinicians. Patients and the public most often participated by taking part in a CPG working group, workshop, meeting, seminar, literature review, or consultation such as a focus group, individual interview, or survey. Patients and the public principally helped formulate recommendations and revise drafts. Limitations. The authors did not contact the authors of the studies. Conclusion. This literature review provides an extensive knowledge base for making PPIPs more effective when developing and implementing CPGs. More research is needed to assess the impact of PPIPs and resources they require.

A voice to be heard: patient and public involvement in health technology assessment and clinical practice guidelines in Malaysia

2021 ◽  
Vol 37 (1) ◽  
Author(s):  
Hanin Farhana Kamaruzaman ◽  
Ku Nurhasni Ku Abd Rahim ◽  
Izzuna Mudla Mohamed Ghazali ◽  
Mohd Aminuddin Mohd Yusof
Keyword(s):  
Clinical Practice ◽  
Health Technology Assessment ◽  
Clinical Practice Guidelines ◽  
Practice Guidelines ◽  
Technology Assessment ◽  
Public Involvement ◽  
Health Technology ◽  
Patient And Public Involvement ◽  
Initial Development ◽  
Limited Health Literacy

Abstract Patient and public involvement (PPI) in health technology assessment (HTA) is widely promoted to ensure that all health-related decisions are made after taking into consideration the viewpoints of important stakeholders. In Malaysia, patients or their representatives have been involved in the development of HTA and Clinical Practice Guidelines (CPG) since 2009 and their influences have been growing steadily over the years. This paper aimed to describe the journey, achievements, challenges, and future direction of the PPI throughout all stages of the development and implementation of HTA and CPG in Malaysia. Currently, in Malaysia, patients or their representatives are mainly involved during the initial development of HTA and CPG drafts as well as during the internal and external reviews. Additionally, they are also encouraged to be involved during the implementation of HTA and CPG recommendations. Although their involvement in this aspect has slowly increased over time, challenges remain in the form of limited representativeness of selected patients or carers, uncertainty on the level of patient involvement allowed during the HTA/CPG development processes, and limited health literacy, which affect their ability to contribute meaningfully throughout the processes. Continuous improvement in these processes is important as patients or their representatives play a pivotal role in ensuring transparency, accountability, and credibility throughout the HTA/CPG development and decision-making processes.

Author Financial Conflicts of Interest, Industry Funding, and Clinical Practice Guidelines for Anticancer Drugs

2015 ◽  
Vol 33 (1) ◽  
pp. 100-106 ◽  
Author(s):  
Ariadna Tibau ◽  
Philippe L. Bedard ◽  
Amirrtha Srikanthan ◽  
Josee-Lyne Ethier ◽  
Francisco E. Vera-Badillo ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Clinical Practice Guidelines ◽  
Practice Guidelines ◽  
Conflicts Of Interest ◽  
Guideline Development ◽  
Industry Funding ◽  
Funding Sources ◽  
Consensus Statements ◽  
Financial Conflicts Of Interest ◽  
Based Medicine

Purpose Clinical practice guidelines (CPGs) and consensus statements (CSs) are used to apply evidence-based medicine or expert recommendations to clinical practice. Here we explore author financial conflicts of interest (FCOIs), sources of guideline funding, and their relationship with endorsement of specific drugs. Methods An electronic search of MEDLINE was conducted to identify CPGs and CSs for common solid cancers published between January 2003 and October 2013. The search was restricted to articles evaluating systemic therapy. We extracted data on self-reported author FCOIs, funding sources, use of manuscript writers, and endorsement of specific drugs in the abstract of the article. Results Of 142 articles evaluated, 64% were CPGs, and 36% were CSs. The proportion of articles reporting FCOIs improved from 11% in 2003 to 93% in 2013 (P for trend < .001). Only 45% of articles explicitly reported funding sources. Of these, 65% disclosed partial or full industry sponsorship. Use of manuscript writers was declared in 13%, but many articles did not explicitly report the role of authors in the writing of the manuscript. Endorsement of specific drugs was significantly associated with author FCOIs (odds ratio [OR], 7.29; P = .001), but not with industry funding (OR, 0.95; P = .37). Conclusion Reporting of FCOIs in CPGs and CSs has improved over time. Despite prevalent funding of guideline development by industry, such funding is not associated with endorsement of specific drugs. Author FCOIs are prevalent, and endorsement of a specific drug seems to be more common when authors have FCOIs with the pharmaceutical company marketing that drug.

scholarly journals A knowledge synthesis of patient and public involvement in clinical practice guidelines: study protocol

2009 ◽  
Vol 4 (1) ◽  
Author(s):  
France Légaré ◽  
Antoine Boivin ◽  
Trudy van der Weijden ◽  
Christine Packenham ◽  
Sylvie Tapp ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Study Protocol ◽  
Clinical Practice Guidelines ◽  
Practice Guidelines ◽  
Public Involvement ◽  
Patient And Public Involvement ◽  
Knowledge Synthesis

scholarly journals Analysis of conflict of interest policies among organizations producing clinical practice guidelines

PLoS ONE ◽  
2021 ◽  
Vol 16 (4) ◽  
pp. e0249267
Author(s):  
J. Henry Brems ◽  
Andrea E. Davis ◽  
Ellen Wright Clayton
Keyword(s):  
Clinical Practice ◽  
Clinical Practice Guidelines ◽  
Practice Guidelines ◽  
Conflict Of Interest ◽  
Conflicts Of Interest ◽  
Public Trust ◽  
Institute Of Medicine ◽  
Internet Search ◽  
The Public ◽  
Document Review

Background Conflicts of interest (COI) jeopardize the validity of Clinical Practice Guidelines (CPGs). When the Institute of Medicine promulgated COI policies in 2011, few organizations met these requirements, but it is unknown if organizations have improved their policies since that time. We sought to evaluate current adherence to IOM standards of COI policies. Methods and findings We conducted a retrospective document review of COI policies and CPGs from organizations that published five or more CPGs between January 1, 2018 and December 31, 2019. Organizations were identified via CPG databases. COI policies were obtained from an internet search. We collected data on i) the number of organizations that have COI policies specific to CPG development, ii) the number of policies meeting each IOM standard and iii) the number of IOM standards met by each policy. COI disclosures from five CPGs of each organization were assessed for adherence to IOM standards. Among the 46 organizations that published 5 or more CPGs, 36 (78%) had a COI policy. Standard 2.2b (requiring divestment of financial COI) was met least frequently, by 2 of 36 (6%) organizations. Standard 2.1 (requiring disclosure of COI) was met most frequently, by 33 of 36 (92%) organizations. A total of 31 of 36 (86%) organizations met 4 or fewer of the 7 IOM standards. Among the 16 organizations limiting COI to a minority of the CPG panel (standard 2.4c) and the 15 organizations prohibiting COI among chairs or co-chairs (standard 2.4d), 12 (75%) and 10 (67%) organizations violated the respective standard in at least one CPG. The main limitations of our study are the exclusion of organizations producing fewer CPGs and ability to assess only publicly available policies. Conclusion Among organizations producing CPGs, COI policies frequently do not meet IOM standards, and organizations often violate their own policies. These shortcomings may undermine the public trust in and thus the utility of CPGs. CPG-producing organizations should improve their COI policies and their strategies to manage COI to increase the trustworthiness of CPGs.

Methodological quality of clinical practice guidelines for nutrition and weight gain during pregnancy: a systematic review

2019 ◽  
Vol 78 (7) ◽  
pp. 546-562 ◽  
Author(s):  
Maria G Grammatikopoulou ◽  
Xenophon Theodoridis ◽  
Konstantinos Gkiouras ◽  
Maria Lampropoulou ◽  
Arianna Petalidou ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Practice ◽  
Weight Gain ◽  
Clinical Practice Guidelines ◽  
Practice Guidelines ◽  
Methodological Quality ◽  
Maternal Nutrition ◽  
Conflicts Of Interest ◽  
Data Extraction ◽  
Institute Of Medicine

Abstract Context Ensuring a healthy pregnancy and achieving optimal gestational weight gain (GWG) are important for maternal and child health. Nevertheless, the nutritional advice provided during pregnancy is often conflicting, suggesting limited adherence to clinical practice guidelines (CPGs). Objective The aim of this review was to identify all CPGs on maternal nutrition and GWG and to critically appraise their methodological quality. Data Sources The MEDLINE/PubMed, Cochrane, Guidelines International Network, and BMJ Best Practice databases, along with gray literature, were searched from inception until February 2019 for CPGs and consensus, position, and practice papers. Study Selection Clinical practice guidelines published in English and containing advice on maternal nutrition or GWG were eligible. Data Extraction Two authors independently extracted data on items pertaining to maternal nutrition or GWG, and CPGs were appraised using the AGREE II instrument. Results Twenty-two CPGs were included. All scored adequately in the “scope” domain, but most were considered inadequate with regard to stakeholder involvement, rigor of development, applicability, and editorial independence. Many CPGs lacked patient or dietician involvement, and more than half did not disclose funding sources or conflicts of interest. Guidance on GWG was based mostly on Institute of Medicine thresholds, while nutrition recommendations appeared scattered and heterogeneous. Conclusion Despite the importance of maternal nutrition and the plethora of advising bodies publishing relevant guidance, there is room for substantial improvement in terms of development standards and content of nutritional recommendations. Systematic review registration PROSPERO registration number CRD42019120898.

scholarly journals Patient and public involvement in the development of clinical practice guidelines: a scoping review protocol

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e037327
Author(s):  
Elizabeth Ann Bryant ◽  
Anna Mae Scott ◽  
Rae Thomas
Keyword(s):  
Clinical Practice ◽  
Clinical Practice Guidelines ◽  
Practice Guidelines ◽  
Scoping Review ◽  
Public Involvement ◽  
Patient And Public Involvement ◽  
National Standards ◽  
Future Research ◽  
Scoping Reviews ◽  
The Usa

IntroductionClinical practice guidelines (CPGs) are intended to optimise patient care by recommending care pathways based on the best available research evidence and practice experience. Patient and public involvement (PPI) in healthcare is recommended based on the expectation that it will improve the quality and relevance of outcomes. There is no consensus on what constitutes meaningful and effective PPI in CPG. We will conduct a scoping review to identify and synthesise knowledge in four key areas: who have been the patients and public previously involved in CPG development, how were they recruited, at what stage in the CPG process were they involved and how were they involved. This knowledge will inform a general model of PPI in CPG to inform CPGs development.Methods and analysisWe will conduct a scoping review using the Methodology for Scoping Reviews refined by the Joanna Briggs Institute. Searches will be conducted in electronic databases (PubMed, Embase, CINAHL and PsycINFO). National standards for developing CPGs from Australia, UK, Canada and the USA will also be identified. A forward and backward citation search will be conducted on the included studies and national standards. Abstracts and full-text studies will be independently screened by two researchers. Extracted data will include study details, type of clinical guideline and the four key areas, which patients and public were involved, how were they recruited, at what stage were they included and how they were involved. Data will be narratively synthesised.Ethics and disseminationAs a scoping review, this study does not require ethics approval. We intend to disseminate the results through publication in a peer-reviewed journal and conference presentations. Furthermore, we will use the findings from our scoping review to inform future research to fill key evidence gaps identified by this review.

scholarly journals Management of Hepatocellular Carcinoma in Japan: JSH Consensus Statements and Recommendations 2021 Update

Liver Cancer ◽  
2021 ◽  
pp. 1-43
Author(s):  
Masatoshi Kudo ◽  
Yusuke Kawamura ◽  
Kiyoshi Hasegawa ◽  
Ryosuke Tateishi ◽  
Kazuya Kariyama ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Clinical Practice ◽  
Public Relations ◽  
Clinical Practice Guidelines ◽  
Practice Guidelines ◽  
Expert Panel ◽  
Clinical Practices ◽  
Fourth Edition ◽  
Level Of Evidence ◽  
Consensus Statements

The Clinical Practice Manual for Hepatocellular Carcinoma was published based on evidence confirmed by the Evidence-based Clinical Practice Guidelines for Hepatocellular Carcinoma along with consensus opinion among a Japan Society of Hepatology (JSH) expert panel on hepatocellular carcinoma (HCC). Since the JSH Clinical Practice Guidelines are based on original articles with extremely high levels of evidence, expert opinions on HCC management in clinical practice or consensus on newly developed treatments are not included. However, the practice manual incorporates the literature based on clinical data, expert opinion, and real-world clinical practice currently conducted in Japan to facilitate its use by clinicians. Alongside each revision of the JSH Guidelines, we issued an update to the manual, with the first edition of the manual published in 2007, the second edition in 2010, the third edition in 2015, and the fourth edition in 2020, which includes the 2017 edition of the JSH Guideline. This article is an excerpt from the fourth edition of the HCC Clinical Practice Manual focusing on pathology, diagnosis, and treatment of HCC. It is designed as a practical manual different from the latest version of the JSH Clinical Practice Guidelines. This practice manual was written by an expert panel from the JSH, with emphasis on the consensus statements and recommendations for the management of HCC proposed by the JSH expert panel. In this article, we included newly developed clinical practices that are relatively common among Japanese experts in this field, although all of their statements are not associated with a high level of evidence, but these practices are likely to be incorporated into guidelines in the future. To write this article, coauthors from different institutions drafted the content and then critically reviewed each other’s work. The revised content was then critically reviewed by the Board of Directors and the Planning and Public Relations Committee of JSH before publication to confirm the consensus statements and recommendations. The consensus statements and recommendations presented in this report represent measures actually being conducted at the highest-level HCC treatment centers in Japan. We hope this article provides insight into the actual situation of HCC practice in Japan, thereby affecting the global practice pattern in the management of HCC.

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