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Quality of professional society guidelines and consensus conference statements in critical care*

Sinuff, Tasnim MD, PhD; Patel, Rakesh V. MD, PharmD, MSc; Adhikari, Neill K. J. MD, CM, MSc; Meade, Maureen O. MD, MSc; Schünemann, Holger J. MD, PhD; Cook, Deborah J. MD, MSc

doi: 10.1097/CCM.0b013e31816a01ec
Feature Articles

Objective: To examine the quality of professional society critical care guidelines and consensus statements.

Data Source: MEDLINE, EMBASE, Cochrane Library (to May 2007), conference proceedings (1990 to May 2007), and personal files.

Study Selection: We considered documents focused on 1) mechanical ventilation and 2) prevention of complications of critical illness associated with mechanical ventilation.

Data Extraction: Independently, two reviewers appraised the methodologic quality of each document using the Grilli, Shaneyfelt, and Appraisal of Guideline Research and Evaluation (AGREE) instruments.

Data Synthesis: We compared the differences in mean scores of the results of the quality instruments to determine variability in quality of the documents. Our inclusion criteria were fulfilled by 13 guidelines and 12 consensus statements. Adherence to current methodologic standards was low. The quality of guidelines was significantly higher than consensus statements (p ≤ .01). Limited data suggested that guideline quality improved from 1985 to 2005. Guidelines had higher AGREE scores compared with consensus statements (57.6 ± 13.6 vs. 41.4 ± 5.8, p = .002, out of possible total of 92). Consensus statements performed poorly in the identification and interpretation of evidence and in their description of the rationale for specific recommendations. Six articles reported receiving industry funding, and 15 reported on conflicts of interest (present in three articles).

Conclusions: The overall quality of critical care professional society guidelines and consensus statements, as assessed by three published quality instruments, is low. Although the quality of guidelines seems to be increasing over time, there is room for improvement, which could in turn facilitate knowledge translation and improve patient care in the intensive care unit.

From the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, and Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Ontario, Canada (TS, NKJA); Department of Critical Care Medicine, University of Ottawa, Ottawa, Ontario, Canada (RVP); Departments of Medicine and Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada (MOM, DJC); and the Department of Epidemiology, Italian National Cancer Institute, Regina Elena, Rome, Italy (HJS).

None of the authors has any financial conflicts of interest, nor were they involved with developing the guideline rating instruments used in the study. Dr. Schünemann is a member of the GRADE Working Group.

Dr. Sinuff is supported, in part, by a Canadian Institutes of Health Research Clinician Scientist Award; Dr. Cook is supported, in part, by the Canadian Institutes of Health Research as a Canada Research Chair.

For information regarding this article, E-mail:

Clinical practice guidelines (CPGs) are evolving as a means of translating evidence into clinical practice in the intensive care unit (ICU) (1–5). Research teams and professional societies have developed CPGs to optimize care in the ICU (6–14).

Evaluations (15–17) of internal medicine guidelines and those for the management of chronic obstructive pulmonary disease (18, 19) found shortcomings in their methods of gathering and grading evidence and formulating recommendations. Almost a decade after guidelines became prevalent in the ICU (2), their quality remains to be assessed. Poor quality may contribute to inappropriate recommendations and low CPG adherence (20). Improving the quality of critical care CPGs may increase adherence and improve the processes of care and patient outcomes.

Numerous consensus conference statements (CCSs) have appeared since the first National Institutes of Health conference in 1983 (21, 22); many jointly developed by international critical care societies. Although critical care clinicians use CCSs to guide patient care (23), their quality has not been evaluated. Given the profusion of CPGs and the international movement to standardize the presentation of practice recommendations, the ideal development, format, funding, and future of CCSs are unclear (24).

Our objective was to determine the quantity and quality of professional society CPGs and CCSs on selected topics within two categories relevant to ICU practice: 1) mechanical ventilation and 2) prevention of complications of critical illness associated with mechanical ventilation. Although CCSs provide recommendations similar to that of CPGs, there are no validated tools to specifically appraise their quality; therefore, we used CPG quality appraisal tools.

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Literature Search and Study Selection.

We searched OVID MEDLINE (1966 through the second week of May 2007), PubMed (including “related articles” through May 2007), EMBASE (1980 through the second week of May 2007), and the Cochrane Library (all databases) (Issue 2, 2007). We also searched personal files and conference proceeding abstracts (1990 through May 2007) of critical care professional societies and their Web sites. References of CCSs and CPGs were hand searched. We contacted primary authors of the CCSs and CPGs to inquire about additional relevant CCSs or CPGs but identified no additional citations. We applied no language restrictions (25).

One author (T. Sinuff) performed the literature search. Independently, two reviewers (T. Sinuff, R. V. Patel) reviewed all citations and applied the following inclusion criteria: original reports of CCSs or CPGs developed by professional societies, specific to predefined areas of critical care (airway management, mechanical ventilation, acute respiratory distress syndrome, weaning from mechanical ventilation, noninvasive ventilation, prevention of ventilator-associated pneumonia, ventilator-induced lung injury, venous thromboembolism, upper gastrointestinal bleeding), and specific recommendations made regarding management or prevention. A single version of multiple simultaneous publications of the same topic was included. Disagreements regarding the eligibility of articles were resolved by consensus or by a third investigator (D. J. Cook).

We used authors’ definitions of CPG and CCS and classified articles as CPGs or CCSs if specified as such. If the authors did not specify the article type, we classified articles based on the description of the details of the CPG and CCS development process.

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Quality Instrument Selection.

There are ≥24 instruments to assess CPG quality (26). Items in these instruments may be grouped into ten domains: validity, reliability, clinical applicability, clinical flexibility, clarity, scheduled review, development team, implementation, dissemination, and evaluation (26). We developed criteria (Table 1) based on these domains and selected instruments if they met at least eight of the ten criteria, including the criterion of instrument validation. From the 24 available instruments (26), we selected Grilli et al. (3 items) (15), Shaneyfelt et al. (25 items) (16), and the Appraisal of Guideline Research and Evaluation (AGREE) Collaboration (23 items) (27).

Table 1

Table 1

We selected the short Grilli (15) instrument to evaluate its correlation with the longer instruments. The Shaneyfelt (16) instrument is intermediate in length. The AGREE instrument (27) is the longest, and it is a revised version of the instrument by Cluzeau et al. (28) but does not include the implementation domain. We chose it because it includes a domain on editorial independence (acknowledging the possibility of conflict of interest) and is the only validated instrument with a numerical scoring scale (Appendix 1 provides instrument details).

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Data Abstraction.

We abstracted data independently and in duplicate on: publication status and year, professional society, sponsoring agency, declaration of conflict of interest of the panel members, expertise of panel members (content, methodology), document format and presentation, provision of clinical aids, document length, summary of recommendations, supporting evidence, and quantification of benefit. We classified recommendations as evidence-based if the document reported a literature search, evidence appraisal, and systematically assessed the quality of the evidence. Alternatively, we classified recommendations as expert opinion–based (interpretation of the evidence in the context of other knowledge or expertise) or consensus-based (used RAND or Delphi methods). All disagreements were resolved by consensus.

Each reviewer provided an overall assessment of the guideline, based on the AGREE instrument (27), and whether it should be strongly recommended, recommended with provisos, or not recommended. Both reviewers made these assessments independently, without previous calibration.

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Data Analysis.

We evaluated agreement between reviewers for document selection using Cohen's κ (29) and report raw agreement for assessment of quality and data abstraction.

Before calculating the total scores for the Grilli (15) and Shaneyfelt (16) instruments, we converted their yes/no, single-item scoring system into a numerical scale (0 = no, 1 = yes). For the AGREE instrument (27), first, we used the AGREE method to calculate standardized domain scores (27) for each CPG and CCS. Second, we calculated a total score by summing the absolute domain scores, acknowledging the AGREE authors’ stated limitations of using total scores (27).

We compared the quality of CPGs with CCSs using the Student's t-test for the difference in mean values of the total scores for each quality instrument (29) after verification of normality. We calculated inter-instrument Pearson's correlation using mean total scores after verification of normality (29). We used linear regression to assess trends over time of the total AGREE score. We report binary data as proportions or percentages, continuous data as mean ± sd or median (interquartile range), and differences as mean and 95% confidence interval. We interpreted statistically significant (two-sided) p values as <.05. All analyses were performed using SPSS 11.0 (SPSS, Chicago, IL).

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Document Selection and Characteristics.

We included 25 CPG and CCS publications (13 CPGs, 12 CCSs) (Fig. 1 [30] and Appendix 2), with perfect agreement (κ = 1.0) on study selection. Topics included airway management (31), mechanical ventilation (32–34), mechanical ventilation for acute respiratory distress syndrome patients (35, 36), weaning (37, 38), noninvasive ventilation (39–41), and prevention of complications (ventilator-associated pneumonia [42–48], ventilator-induced lung injury [49], venous thromboembolism [50–53], and stress ulceration [54, 55].

Figure 1

Figure 1

Few documents reported the development panel's composition, including content (24%) (33, 35, 43, 45, 48, 54) and methods experts (8%) (43, 45). Nine (36%) reported involvement of the professional society (32, 37, 39, 40, 43, 45, 48, 49, 54). Six (24%) disclosed pharmaceutical (32, 43, 47, 52) or ventilator company (39, 41) funding. Fifteen (60%) reported on financial conflicts of interest (32, 37–41, 46, 48, 49, 51, 54, 55); three (12%) disclosed conflicts (42, 43, 45).

Document format was consistent: 23 were text only, and two (36, 54) combined text and an algorithm. Only one (45) provided a clinical decision aid in the form of a quick reference guide. Documents were a median of 19 (7, 35) pages in length; the median number of tables was 2 (0, 4). We classified recommendations as evidence-based in 16 (64%) documents (33, 36–43, 45, 46, 48–51, 55). We were unable to determine the type of recommendations (evidence-based, expert-based, or combination) in eight (32%) (31, 34–36, 44, 47, 52, 53). Only nine (36%) provided an executive summary of recommendations (31, 38, 40, 42, 45–46, 50, 51, 54), 20 (80%) provided a synopsis of supporting evidence (33, 35–40, 42–54), and three (12%) quantified the benefit of the CPG (50, 51, 53). Interrater raw agreement was 98% for data abstraction.

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Quality and Determinants of Quality.

Individual document quality scores are presented in Appendix 2. Raw agreement between reviewers for document quality was 85%. Overall quality was low (Table 2). CPGs had higher quality than CCSs; the differences in mean (95% confidence interval) values of the total scores (CPG − CCSs) were 1.3 (0.5, 2.2; p = .003) for the Grilli instrument, 4.4 (1.4, 7.3; p = .006) for the Shaneyfelt instrument, and 16.2 (7.2, 25.2; p = .001) for the AGREE instrument. There was significant pair-wise correlation between the instruments of the quality mean scores of these documents (Pearson's correlation coefficients: 0.91 for AGREE–Shaneyfelt, 0.71 for Shaneyfelt–Grilli, 0.63 for AGREE–Grilli; p = .01 for all correlations).

Table 2

Table 2

CPGs scored significantly higher than CCSs in the evidence identification and summary and formulation of recommendations subsections of the Shaneyfelt instrument (16) (Table 3) (mean differences of 2.5 [1.0, 3.9; p = .002] and 1.0 [0.3, 1.8; p = .007], respectively). CPGs scored higher in other subsections, but differences were not statistically significant. CPGs performed well (mean ≥50% of total possible score) in two subsections: details of development process and details of recommendations. CCSs performed poorly in all subsections.

Table 3

Table 3

CPGs scored significantly higher than CCSs in four of six domains of the AGREE instrument (27) (Table 3): rigor of development (p = .002), clarity and presentation (p < .001), applicability (p = .05), and editorial independence (p = .001). Using AGREE definitions (27), 12 documents (48%) were not recommended for use (31–33, 34, 42, 46–48, 51–53, 55), six (24%) were recommended for use with provisos or alterations (33, 35, 39, 41, 44, 50), and only six (24%) were strongly recommended for use (37, 38, 40, 43, 45, 54). Limited data suggest that the quality of CPGs has improved significantly in the past 20 yrs (Fig. 2) (40-point increase in the total AGREE score, p < .001) (27), whereas the quality of CCSs remained essentially unchanged (10-point increase, p = .52) out of a possible total score of 92.

Figure 2

Figure 2

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In this systematic review of the quality of 25 critical care CCSs and CPGs, we found modest adherence to current methodologic standards. CPGs were of higher quality than CCSs, although both types of documents had methodologic weaknesses in the domains of description of stakeholder involvement, rigor of development, applicability in practice, and editorial independence. Using standard CPG quality appraisal instruments, we found that the quality of CPGs seems to have improved over time, whereas that of CCSs has not.

Although the original mandate of CCSs included assessing and summarizing research (21, 22, 56), their role has evolved to incorporate clinical recommendations (35, 41, 46, 50, 51). Without instruments to evaluate CCSs, we used CPG appraisal instruments to evaluate their quality. Given the low scores of CCSs, and because they include recommendations for clinical practice (23), their content, format, or role could be reexamined. For example, CCSs could be reformulated as distilled sources of referential knowledge with the aim of focusing on the description of new or sparse evidence. Because clinicians have an unmet need for rapid-advice documents, streamlined CCS development may be helpful for emerging healthcare problems in the face of changing, incomplete knowledge. A recent example is the World Health Organization statement on pharmacologic management of avian flu (57). Rapid-advice documents could help to produce more timely clinical recommendations. In addition, the process of developing critical care CCSs has other benefits. Often, consensus conferences are focused on challenging, topical, and controversial issues. The meetings themselves are sometimes open to members of the general ICU community. CCSs organized by groups, such as the Society of Critical Care Medicine, American Thoracic Society, and the European Society of Intensive Care Medicine, provide a unique opportunity for international experts to convene and exchange research findings of global importance, which often produces valuable summary statements or broadly applicable recommendations. Finally, an important component of these documents in the future may be to serve as a primary role for generating research agendas.

Poor guideline quality is an important barrier to their use (58). Clinicians report placing little value on non–evidence-based CPGs (58). We found that more explicit identification and interpretation of the evidence contribute to higher-quality CPGs. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) (24) framework provides a systematic and explicit approach to making judgments about the validity of research evidence. More consistent use of the GRADE approach may increase the quality of CPGs and make more transparent the methods by which scientific evidence, experience, and values are integrated into clinical recommendations.

We found that both CPGs and CCSs performed poorly in the AGREE category of editorial independence. This is consistent with previous work showing that conflicts of interest influence research conduct and reporting of study results (59). We also found that 40% of documents did not report on conflicts of interest, as others have found (60, 61). Although panel members disclosed no financial conflicts in 80% (12/15) of reports addressing this issue, such conflicts are likely underreported (60, 61). Recently, the ATS Conference on the ethical conduct of clinical research involving critically ill patients strongly recommended that the critical care community should “disclose [conflicts of interest] whenever possible during the process of research dissemination” (59).

Strengths of our systematic review include the quality assessment of two types of knowledge-translation documents (CPGs and CCSs) prevalent in the critical care literature. For the topics we addressed, our literature search was comprehensive. Finally, we undertook duplicate appraisal of quality using three different instruments.

Limitations of this systematic review include our reliance on self-reports of document development, which may underestimate true document quality. On the other hand, reporting of process (e.g., application of an evidence grading system) does not guarantee optimal implementation of the methods. To address these limitations, CPG reporting standards have recently been developed (62), and major international professional guideline development societies (e.g., the National Institute for Health and Clinical Excellence [NICE], Scottish Intercollegiate Guidelines Network [SIGN]) have detailed procedures to ensure adequate training of guideline developers (63, 64). The National Institute for Health and Clinical Excellence is likely the organization devoting the most resources and considerable expertise to improving guideline development. The methods of the National Institute for Health and Clinical Excellence are under continuous development and have undergone a number of improvements. Interestingly, experts (and, thus, classic expert consensus) are primarily involved as consultants but not as authors of recommendations. Second, only one of the three instruments we used was extensively validated (AGREE) (27), which may limit inferences drawn from these results. Third, the appraisal scores corresponding to a clinically important difference in document quality has not been defined. Finally, we did not incorporate every CPG topic relevant to critical care. Other publication types such as task force documents (addressing the structure of the ICU and critical care training programs) could also be formally evaluated in the future.

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Overall, the current quality of critical care CPGs and CCSs leave room for improvement. Because these documents are common and resource-intensive to produce, our findings have important implications. This analysis supports the rationale for guideline development standards (GRADE [24]) and enhanced reporting transparency (Conference on Guideline Standardization [COGS]) (62). These advances could help to produce higher-quality documents that both educate clinicians and inform the process of care in the ICU. Further research evaluating the effect of CPGs and CCSs on patient outcomes is needed.

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We thank France Clarke for help with the data abstraction of the French documents and Dr. Roman Jaeschke for thoughtful suggestions.

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Appendix 2

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*See also p. 1360.

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guidelines; consensus statements; professional society; critical care; quality; review

© 2008 by the Society of Critical Care Medicine and Lippincott Williams & Wilkins