What Is Known
Many clinical practice guidelines (CPGs) are being published, including in rehabilitation . Appraisers of CPGs frequently find them unsuitable for practice, even with modifications. What determines the quality of CPGs is unclear.
What Is New
This overview study, using 40 reviews that appraised 504 CPGs using the Appraisal of Guidelines for Research & Evaluation II (AGREE II) tool, found that the AGREE overall quality rating is most strongly dependent on rigor of development. The recommendation for CPG use depends most on rigor, scope and purpose, and clarity of presentation. Clinical practice guideline developers should focus on improving their guidelines in these areas to have a positive reception by clinicians.
In 2011, clinical practice guidelines (CPGs) were defined by the Institute of Medicine as “statements that include recommendations intended to optimize patient care that are informed by a systematic review of evidence and an appraisal of the benefits and harms of alternative care options.”1 (p29) Clinical practice guidelines make recommendations for screening, diagnosis or assessment, treatment, and management for a particular disorder or patient problem—most commonly for one of these clinical activities, but sometimes for some or all combined. In rehabilitation , CPGs are as common as elsewhere in health care—a May 19, 2020, PubMed search of “((physical medicine) OR rehabilitation ) AND (clinical practice guideline)” gave more than 7900 hits, although it is unknown how many of those represent CPGs that meet the six Institute of Medicine quality standards.1 (p5)
Increasingly, clinicians are pressured to use CPGs in their practice, but as expressed in the title of the Institute of Medicine volume, these cannot all be trusted to be free of conflicts of interest or based on a comprehensive and through-going review of the empirical literature. As a consequence, many instruments have been developed to assist potential guideline users in critically assessing their quality. The last comprehensive review of these checklists and appraisal tools was performed by Siering et al.2 in 2013, who identified 40 instruments in all. Since then, additional appraisal tools have been published (e.g., the checklists by Shaughnessy et al.3 and Siebenhofer et al.4 ), but no new and comprehensive review was identified.
Siering et al.2 extracted all questions and criteria from the 40 instruments that they found and performed a content analysis, which resulted in a list of 13 domains encompassing 33 unique items. They next coded the 40 tools to determine how many of the Siering items and of the Siering domains each covered. Appraisal of Guidelines for Research & Evaluation II (AGREE II) was the second-best instrument, covering all 13 Siering domains with one or more of its items and covering 26 of the 33 Siering items. (The quantitatively best tool was DELBI,5 which, in contrast with AGREE II, has never been validated, and has seen little use outside of Germany.) Thus, it would seem that AGREE II, which has been used in dozens of reviews to assess hundreds of CPGs, is a good choice for appraising the quality of CPGs.
The AGREE II consists of 23 items that are combined into six “domain scores”: D1, scope and purpose; D2, stakeholder involvement; D3, rigor of development; D4, clarity of presentation; D5, applicability; and D6, editorial independence; in addition, it asks for an overall quality assessment and for a recommendation for use of the CPG.6 Overview studies that summarized across reviews that had used AGREE or AGREE II to evaluate CPGs have concluded that CPGs often are of low quality, especially where it comes to applicability, and cannot be recommended, even with modifications, in 18%–38% of cases.7–11 A recent overview study, which was limited to rehabilitation CPGs, came to the same conclusion as the nonrehabilitation overviews did; based on 40 reviews appraising 544 CPGs published from 1994 to 2019, only 80% could be recommended, with or without modifications. The mean scores on the six AGREE II domains, on a 0–100 percentage scale, were as follows: (1) scope and purpose, 72; (2) stakeholder involvement, 53; (3) rigor of development, 56; (4) clarity of presentation, 71; (5) applicability, 34; and (6) editorial independence, 50.12
Given the discrepancies between the 40 reviews in the mean scores that they assigned for each of the six AGREE II domains,12 the question arises: what do authors who appraise CPGs consider when they make a judgment on the overall quality of a CPG and decide on a recommendation for its use? Two studies have tried to answer the question. Hoffmann-Esser et al.13 conducted an online survey of 58 German-speaking guideline appraisers and guideline users, asking them to indicate the “potential influence of the [23] AGREE II items on the two overall assessments (overall guideline quality and recommendation for use)” by rating the “strength of the influence on a Likert scale (0 = no influence to 5 = very strong influence).” (The AGREE II Manual indicates that in making the two global assessments, scores on the 23 items and six domains should be considered, but the two should not be calculated from them. It also notes that the six domain scores “are independent and should not be aggregated into a single quality score.”)6 (p9) The items in domains 3 (rigor of development), 4 (clarity), and 6 (editorial independence) were stated by respondents to have the most impact. An open-ended question about items considered of influence tended to confirm this.13
A different approach was taken by Hatakeyama et al.,14 who had three appraisers evaluate 206 Japanese CPGs using AGREE II, and used multiple regression analysis to determine the impact of the six domain scores on the overall quality assessment item. Rigor had the greatest influence (β = 0.46), followed by clarity (0.19) and applicability (0.16).14 This clearly is not in line with what Hoffmann-Esser’s respondents thought that they emphasized. Very surprising is also that her respondents gave little weight to applicability, which (at least in rehabilitation and other complex interventions) would seem to be a key CPG quality issue.12
The objective of the present study was to answer the question: in appraising rehabilitation CPGs, which characteristics do appraisers give the most weight in deciding on an overall quality assessment and in making a recommendation for use? The answer presumably would be useful to rehabilitation CPG authors, suggesting those areas of their guideline that need most attention to make the entire product acceptable to and be maximally useful for clinicians.
We addressed our objective using some of the data found in our previous appraisal of rehabilitation CPGs. However, we dropped reviews that did not report overall quality or recommendation for use and updated the literature search, including articles published from August 2019 to January 2020.
METHODS
This is an overview study, synthesizing information from published systematic reviews (SRs) that applied AGREE II to CPGs. It conforms to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guideline and reports the required information accordingly (see Supplemental Checklist, Supplemental Digital Content 1, https://links.lww.com/PHM/B175 ).
Literature Search
The following bibliographic databases were searched for the period January 1, 2017, through January 22, 2020: Medline (Ovid); Cochrane Library Databases (Cochrane Library, Wiley); PsycINFO (Ovid), Embase (Embase.com ); CINAHL Complete (EBSCO); and Web of Science (Clarivate). Search terms included the acronym and full name of the AGREE II tool; no language limits were applied. Retrieved records were organized and deduplicated using the bibliographic management software Endnote X9.
Data Selection
After deduplication, 573 abstracts remained, which were reviewed independently by two researchers (pairs made up of IW, TA, and four other rehabilitation experts), who selected articles that seemed to use AGREE II to evaluate the quality of rehabilitation CPGs. The definition of rehabilitation was modified from one developed by Levack et al.15 : “an intervention provided by or prescribed by rehabilitation professionals to patients to improve their functioning, maximize their independence, prevent or manage secondary complications of a chronic, disabling health condition or to manage functional implications of a chronic health condition.”(p4) Disagreements between the two screeners were resolved by discussion or by obtaining and scrutinizing the full text if agreement could not be attained. Next, two researchers independently reviewed the full texts selected by the two screeners, using these criteria:
AGREE II was used to evaluate existing CPGs, not to develop one.
The report was in English, Spanish, Portuguese, German, French, or Dutch and was published in a peer-reviewed journal.
All or at least most of the CPGs rated involved rehabilitation as here defined.
The primary target of the CPGs was a rehabilitation clinician or other healthcare provider, not the patient or a family caregiver.
The six AGREE II domain scores and/or the 23 item scores were reported, in tables or supplemental digital content, for each CPG.
For each CPG, the AGREE II “overall quality” rating and/or the recommendation for use were provided, and these had not been determined as a mathematical function of the six AGREE II domain scores
Data Extraction
A two-part Excel form was created and piloted to extract all relevant data. Part 1 focused on the review article providing appraisals of CPGs and included the following items:
Number of guidelines evaluated using AGREE II
Number of AGREE II raters for each CPG
Presence of overall quality ratings and their mathematical independence of the six domain scores
Presence of recommendations for CPG use and their independence of the six domain scores
Part 2 dealt with the CPGs themselves as reported in the review and included the following information:
The six AGREE II domain scores, if provided
The 23 AGREE II item scores, if provided
The AGREE II overall quality rating, on the 1–7 scale, where 1 = lowest possible quality and 7 = highest possible quality, or transformed to that scale
The recommendation made with respect to the CPG, using the AGREE II standard terminology or an equivalent: “recommended,” “recommended with modification,” and “not recommended,” as provided in the review
The extraction of information was done by DD and checked by MD. In case of disagreement, discussion took place to resolve the issue. Many articles reported AGREE II “overall quality” ratings on a percent scale, not a 1–7 scale. These were back transformed, taking into account the number of raters that had been used. In instances where a consensus recommendation for a particular CPG was not reported, but only those of the two or more appraisers individually, an algorithm was used, which was similar to that developed by Hoffmann-Esser et al.16 : “majority vote” was used to determine a “consensus” recommendation; if there was no majority, the median vote was used.
Data Processing and Synthesis
All data were uploaded to SPSS for processing and CPG description. When articles presented AGREE II item scores but not domain scores, the latter were calculated based on the former, using the AGREE II formulas.6 Stata 16.1 statistical software was used to conduct the analysis of how the domain scores together influenced global assessments. Two mixed-effects models with a random intercept were fitted using maximum likelihood. The response variables were the overall quality score and the recommendation for use. In both models, the six domain scores were the predictors used, which were entered simultaneously. A mixed-effects linear regression model was used to predict the overall quality score. A mixed-effects ordered logit model was used to predict recommendation (ie, not recommended, recommended with modification, and recommended). The mixed-effects model was used because all but one review made more than one rating (ie, CPG AGREE II evaluation), which causes the data to be clustered. The mixed model is able to handle the clustering when estimating the model parameters.
RESULTS
The 40 articles provided AGREE II ratings for a total of 504 CPGs, with a range of 1–48 guidelines per review (mean = 12.6, SD = 10.0, median = 8). Table 1 lists these review articles, the topic area of each, and their mean scores on the six domains. Also provided is the mean overall quality score, which was provided by 33 reviews, which evaluated 384 CPGs (on average = 11.6). The last two columns provide, by review, the percentage of CPGs that were recommended and recommended with modifications, respectively; this information was supplied by 24 reviews, which between them appraised 280 CPGs (average = 11.7). Inspection of the table shows quite some variability from one review to the next in mean domain scores, overall rating, and percentages recommended. Information to explain this variation based on the topic area covered, rater severity, or other factors is not available.
TABLE 1 -
Nature and outcomes of 40 reviews using the AGREE II tool to evaluate
rehabilitation CPGs
Study
Topic
No. CPGs
Mean AGREE II Domain Scores
a
Mean Overall Rating
Recommendation, %
b
D1
D2
D3
D4
D5
D6
Yes
Mod.
Andrade et al.17 (2020)
Rehabilitation after ACL reconstruction
6
64
55
61
74
25
60
4.8
—
—
Anwer et al.18 (2018)
Management of type 2 DM in adults
7
90
83
82
95
78
85
6.2
14
86
Appenteng et al.19 (2018)
Management of acute pediatric TBI
17
85
58
59
82
39
53
5.2
23
77
Bhatt et al.20 (2018)
Management of type 2 DM in children
21
69
58
47
73
49
44
—
33
19
Boaden et al.21 (2020)
Performing videofluoroscopic swallowing studies
7
92
45
30
52
23
22
3.9
—
—
Bragge et al.22 (2019)
Management of SCI neurogenic bladder
8
72
42
52
84
33
68
4.8
—
—
Bravo-Balado et al.23 (2019)
Management of overactive bladder
7
60
41
54
88
23
52
4.5
—
—
Coronado-Zarco et al.24 (2019)
Nonpharmacological osteoporosis treatment
12
62
50
53
63
33
40
4.1
0
75
Filiatreault et al.25 (2018)
Preoperative hip fracture management
5
79
60
55
78
49
53
4.5
—
—
Gagliardi et al.26 (2019)
Patient-centered care for women
27
89
62
60
85
43
64
—
0
67
Grammatikopoulou et al.27 (2018)
Nutrition for adults with severe burns
8
70
41
47
74
35
55
4.3
38
38
Green et al.28 (2019)
Treatment of acute lateral
ankle ligament sprains in adults
7
66
51
32
81
8
25
4.0
—
—
Herzig et al.29 (2018)
Acute noncancer pain management
4
73
51
63
63
31
61
4.4
75
25
Hoedl et al.30 (2018)
Treatment of urinary incontinence in NH patients
5
67
38
58
74
28
76
4.2
—
—
Hoydonckx et al.31 (2019)
Chronic pain intervention
4
94
50
81
84
44
53
5.2
0
75
Irajpour et al.32 (2019)
End-of-life care
8
68
74
59
83
66
45
5.5
38
50
Jaggi et al.33 (2018)
Neurogenic lower urinary tract management
3
86
80
82
90
69
85
6.0
33
67
Jolliffe et al.34 (2018)
Rehabilitation after ABI
20
85
68
64
76
37
58
—
75
20
Karimi et al.35 (2019)
Administering chemotherapy drugs
4
95
89
85
94
89
87
75
25
Kim et al.36 (2019)
Rehabilitation after brain tumors
2
61
83
55
75
60
63
5.0
0
100
Kiriakova et al.37 (2019)
Bone health in women with premature ovarian insufficiency
16
85
58
57
87
44
72
—
25
50
Knight et al.38 (2019)
Rehabilitation for children with ABI
9
99
77
82
90
47
86
5.6
—
—
Lee et al.39 (2019)
Rehabilitation after TBI
4
97
68
86
93
75
73
5.8
50
50
Lin et al.40 (2018)
Management of musculoskeletal pain
34
72
44
47
59
26
32
3.7
—
—
Mandl et al.41 (2019)
Poststroke rehabilitation of aphasia and dysarthria
6
44
56
39
59
28
61
3.5
0
100
O’Sullivan et al.42 (2018)
Testing and management of various diagnostic groups
27
86
46
55
81
33
43
4.2
33
44
Parikh et al.43 (2019)
Diagnosis and treatment of neck pain
46
68
55
47
63
31
44
4.1
—
—
Pattuwage et al.44 (2017)
Management of spasticity in TBI
5
87
69
53
83
25
58
5.3
—
—
Perez-Panero et al.45 (2019)
Diagnosis and management of diabetic foot
12
65
48
53
62
36
47
4.7
—
—
Reis et al.46 (2017)
Treatment of obesity
21
89
69
71
84
49
65
4.9
—
—
Sankah et al.47 (2019)
Exercise for hand osteoarthritis
8
90
88
77
83
43
81
4.8
63
38
Shallwani et al.48 (2019)
Physical activity for people with cancer
20
81
64
64
77
40
67
4.6
—
—
Shetty et al.49 (2018)
Worker’s compensation disability management
1
64
67
55
75
74
69
4.5
0
100
Tamas et al.50 (2018)
Diagnosis and treatment of dystonia
15
64
34
29
54
14
22
—
13
67
Tan et al.51 (2019)
Treatment of venous leg ulcers
14
56
46
52
74
27
46
4.9
—
—
Uzeloto et al.52 (2017)
PT management in respiratory disease
33
79
52
61
79
37
54
4.8
21
70
van der Ploeg et al.53 (2019)
(Discontinuation of) statin treatment in older adults
18
72
54
55
81
50
49
4.5
—
—
Wang et al.54 (2019)
Poststroke rehabilitation of aphasia
8
96
84
67
77
64
91
5.8
75
13
Zhang et al.55 (2019)
Treatment of diabetic foot ulcers
8
89
69
69
88
53
66
5.5
75
25
Zhao et al.56 (2019)
Nutrition for cancer patients
17
74
37
43
75
23
35
—
12
65
All mean/percentage
c
77
56
56
75
38
53
4.6
30
53
All SD
c
19
24
25
19
26
33
1.4
—
—
a Domain: D1, scope and purpose; D2, stakeholder involvement; D3, rigor of development; D4, clarity of presentation; D5, applicability; D6, editorial independence.
b Yes: yes, recommended; Mod: recommended with modification. “Not recommended” is omitted.
c The mean and SD for D1 through D6 are based on the 504 CPGs directly, NOT on the 40 means shown here. The number of cases for the overall quality rating is 384, and the number of cases for the recommendation percentages is 280.
ABI, acquired brain injury; ACL, anterior cruciate ligament; DM, diabetes mellitus; NH, nursing home; PT, physical therapy; SCI, spinal cord injury; TBI, traumatic brain injury.
Table 2 shows that the six domain scores are all correlated with one another, at an r value of 0.42 or greater (all significant at the 0.0001 level). They also all are correlated with the overall CPG quality rating, at the level of 0.60 or greater. Figure 1 shows the association between the type of recommendation provided and the domain scores, as well as with the overall score. These data suggest that the influence of the six domains on the two global quality judgments is not very discrepant; however, nesting is not taken into account here.
TABLE 2 -
Intercorrelations of the domain scores and their correlation with the overall rating
D1
D2
D3
D4
D5
D6
Domain 1. Scope and purpose
Domain 2. Stakeholder involvement
0.60
Domain 3. Rigor of development
0.63
0.70
Domain 4. Clarity of presentation
0.55
0.52
0.63
Domain 5. Applicability
0.46
0.70
0.64
0.51
Domain 6. Editorial independence
0.42
0.51
0.60
0.46
0.53
Overall quality rating of the CPG
0.60
0.72
0.84
0.70
0.70
0.66
Based on the 383 CPGs for which an overall quality rating was available.
FIGURE 1: Mean score on the six AGREE II domains, and mean overall score, by type of recommendation. Note: The values of the overall quality score were multiplied by 15 to make their scale (1–7) approximately the same as that of the domain scores. Mean scores for D1 to D6 are based on, respectively: not recommended: 48 cases; recommended with modifications: 143 cases; yes, recommended: 83 cases. For the overall CPG quality rating, the number of cases is 17, 87, and 50, respectively.
The omnibus test for the overall quality model (Table 3 ) that took nesting into account was statistically significant (P < 0.001) with an R 2 value of 0.53. All six of the domain scores were statistically significant predictors of the overall score. D3 (rigor of development) was the strongest predictor, whereas D1 (scope and purpose) was the weakest one.
TABLE 3 -
Results of mixed model regression of overall quality rating and CPG use recommendation on the six AGREE II domains
AGREE II Domain
Global Quality Rating
Recommendation for CPG Use
Coef.
SE
z
P
Coef.
SE
z
P
D1. Scope and purpose
0.007
0.002
3.53
0.000
0.056
0.019
2.98
0.003
D2. Stakeholder involvement
0.007
0.002
3.86
0.000
0.033
0.016
2.09
0.037
D3. Rigor of development
0.024
0.002
12.55
0.000
0.077
0.017
4.57
0.000
D4. Clarity of presentation
0.013
0.002
5.97
0.000
0.061
0.019
3.23
0.001
D5. Applicability
0.010
0.002
6.10
0.000
0.019
0.013
1.46
0.145
D6. Editorial independence
0.007
0.001
6.05
0.000
0.025
0.008
3.29
0.001
Constant
0.597
0.158
3.78
0.000
—
—
—
—
R
2
0.53
Pseudo R
2
0.53
Similarly, the omnibus test for the CPG use recommendation model was statistically significant (P < 0.001) with a pseudo R 2 value of 0.53 (Table 3 ). Five of the six domain scores were significant predictors of the recommendation. D3 was also the strongest predictor in this model. D5 (applicability) was the weakest predictor (P = 0.15).
DISCUSSION
Ever since CPGs were first published almost half a century ago, there has been concern about their quality, including the strength of the underlying evidence; the methods used to come to recommendations; the lack of consideration of patients’ values and realities; conflicts of interest of CPG developers; and inconsistent recommendations in CPGs that dealt with the same evidence to come to recommendations in the same clinical area.1
In this study, only 53% of the variance in overall CPG quality rating for the 384 CPGs was explained by the six domain scores, suggesting that the raters and rater teams were not very consistent and/or that they often took into account much information not covered in the 23 AGREE II items. All six domains contributed to the overall rating, with D3, rigor of development, clearly the most important factor (coefficient = 0.024), and D1, scope and purpose; D2, stakeholder involvement; and D6, editorial independence having relatively limited impact, all with a coefficient of 0.007. These findings correspond somewhat with those of Hatakeyama et al.,14 who reported a strong influence of D3 rigor, followed by D4 clarity of presentation and D5 applicability.
About as much variation in CPG recommendation was explained by the six domains (pseudo R 2 = 0.53). Here too, D3 was the most important predictor, but D1 and D4 (clarity of presentation) had similar coefficients. Surprisingly, applicability (D5) was not statistically significant. Hatakeyama et al.14 did not report on determinants of CPG use recommendations, so the present findings cannot be compared with theirs. Currently, there is no explanation why the factors determining an overall rating are so dissimilar from those having an impact on CPG use recommendation.
These findings suggest that for rehabilitation CPGs, there is no single domain or factor that, if enriched, can by itself improve the likelihood that a CPG is highly rated or is recommended for use. Therefore, teams of rehabilitation clinicians, methodologists, and stakeholders working to create new CPGs or to update existing ones have to pay careful attention to all issues that are tapped by the 23 AGREE II items. Surprisingly, applicability plays no role in predicting a recommendation, which is surprising, especially given the fact that in both within rehabilitation 12 and outside of it,7–11 applicability consistently gets the lowest scores on the six domains.
Rating the 23 items included in AGREE II can be subjective, which is why the manual recommends using for each guideline at least two appraisers, and preferably four, whose scores are “averaged” to develop the six domain scores.6 However, a common complaint is that the manual offers no guidance for the scores intermediate between the Likert scale extremes used to rate the 23 items: 1 indicates strongly disagree and 7 indicates strongly agree, allowing for that subjectivity. The manual states: “A score between 2 and 6 is assigned when the reporting of the AGREE II item does not meet the full criteria or considerations. A score is assigned depending on the completeness and quality of reporting.”6 (p8) For the two global assessment items, no guidance is provided as to whether the scores of the multiple raters should be averaged or whether they should discuss discrepant ratings and recommendations to come to a consensus. As a consequence, many of the 40 articles provided the overall rating for each appraiser (which here were averaged) and the use recommendation by each separate assessor (which were “averaged” using the algorithm). If there is criticism that CPG development and implementation instruction manuals leave much to be desired,57,58 the same holds true for the most used CPGs assessment tool. The AGREE II offers guidance on how much to bank on a CPG, but its scores should not be treated by rehabilitation clinicians as the last word.
Of the six previous overview studies that compiled AGREE II appraisals from published reviews, two were descriptive, and as such had no need to use advanced statistical methods.8,12 Three others, however, tested (implicit) hypotheses as to the association of domain scores and year of publication and should have taken this step.7,10,11 Only Gagliardi and Brouwers9 in testing the association between domain 5 (Applicability) scores and publication year, country of publication, and type of CPG developer used mixed effect models as appropriate in this situation. (In the case of Hatakeyama et al.,14 there was no need for such modeling because all 206 of their CPGs were evaluated by the same team.)
It should be noted that whatever the number of items and domains in a CPG appraisal tool, none requires the assessor to independently address the nature of the evidence underlying recommendations. This has been observed by a number of authors.59–62 Vlayen et al.63 stated, in 2005: “in order to evaluate the quality of the clinical content and more specifically the evidence base of a CPG, verification of the completeness and the quality of the literature search and its analysis has to be added to the process of validation by an appraisal instrument.”(p239) Given that CPGs may run into dozens if not hundreds of pages, and reviews may include 30 or more CPGs, this would be an herculean task. Instead, reviewers score “rigor of development” or a similar domain, based on the protocol the CPG authors (claimed to have) used. Thus, even a high overall CPG quality rating cum recommendation based on multiple methodology items is no guarantee that a particular guideline is making recommendations based on all the relevant evidence properly assessed and evaluated. There is an implied trust that the guideline developers were thorough in their literature search and verification of evidence. However, CPGs that are rated highly on rigor of development are likely to be better than the ones that were rater poorly on this domain, because of flawed methodology.
Developing a CPG is time-consuming and therefore expensive, even if much of the time is contributed by volunteers in academia and healthcare organizations. That almost one fifth cannot be recommended for use, even with modifications, whether in health services in general7,8,10,11 or in rehabilitation specifically (Table 1 ) means a sizeable waste of effort. (Across the 40 reviews used here, only 35% of 504 CPGs were recommended without any modification.) If these CPGs are indeed not consulted and implemented by individual clinicians and healthcare organizations, opportunities are missed to provide optimal care, eliminate useless or even harmful assessments and treatments, and reduce variations in nature and quantity of rehabilitation treatments, from organization to organization and from provider to provider. Because CPGs are such complex documents, a multitude of quality criteria can be, and have been, applied to them. Not all of these criteria may be considered important enough to actually apply, and the ones users do want to use may have uneven importance in their eyes. This analysis suggests that of the criteria used in the AGREE II tool, some are more important than others, but all play a role in telling good, bad, and indifferent CPGs apart.
Limitations
We used a functional definition of rehabilitation , which was applied to 40 review articles, which often provided minimal information on the CPGs being appraised and on the degree that rehabilitation practices or services were included in their recommendations. The reviews frequently were not clear about their use of the standardized AGREE II procedures for item scoring, overall quality rating, and making recommendations, and e-mail requests for clarification often were not answered. A strenuous effort was made, using the text in the methods section of the reviews found in the bibliographic search, to limit the secondary studies in this overview to those which offered an overall quality rating and/or a CPG use recommendation that, per AGREE II protocol, were not a mathematical derivative of the item or domain scores. We used six comprehensive bibliographic data bases to identify review articles but may have missed some that did not use the term “AGREE II” (or its full expansion) in title or abstract.
CONCLUSIONS
Based on 40 review studies that used the most often used and best validated CPG appraisal tool, AGREE II, to evaluate 504 rehabilitation CPGs, we conclude that these CPGs often have weak points and are not recommended for use 17% of the time. Although the six AGREE II domains differ somewhat in their impact on making a recommendation and on the overall quality rating, it would seem that CPG developers need to pay attention to all of them to improve the quality of rehabilitation CPGs.
ACKNOWLEDGMENTS
The authors thank Jennie Feldpausch, BS; Andrew Moul, PT, DPT, NCS; Jennifer Moore, PT, DHS, NCS; and Patricia Heyn, PhD, FACRM, FGSA, for contributing to early phases of this research.
REFERENCES
1. Institute of Medicine:
Clinical Practice Guidelines We Can Trust . Washington, DC, National Academies Press, 2011
2. Siering U, Eikermann M, Hausner E, et al.: Appraisal tools for clinical practice guidelines: a systematic review.
PLoS One 2013;8:e82915
3. Shaughnessy AF, Vaswani A, Andrews BK, et al.: Developing a clinician friendly tool to identify useful clinical practice guidelines: G-TRUST.
Ann Fam Med 2017;15:413–8
4. Siebenhofer A, Semlitsch T, Herborn T, et al.: Validation and reliability of a guideline appraisal mini-checklist for daily practice use.
BMC Med Res Methodol 2016;16:39
5. Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften e.V. (AWMF) and Ärztliches Zentrum für Qualität in der Medizin (ÄZQ): German Instrument for Methodological Guideline Appraisal [Deutsches Instrument zur methodischen Leitlinien-Bewertung (DELBI)] Version: 2005/2006 + Domain 8 (2008). 2008. Available at:
https://www.leitlinien.de/mdb/edocs/pdf/literatur/german-guideline-appraisal-instrument-delbi.pdf . Accessed May 1, 2020
6. AGREE Next Steps Consortium. The AGREE II Instrument [Electronic version]. 2017. Available at:
http://www.agreetrust.org . Accessed May 9, 2020
7. Alonso-Coello P, Irfan A, Sola I, et al.: The quality of clinical practice guidelines over the last two decades: a systematic review of guideline appraisal studies.
Qual Saf Health Care 2010;19:e58
8. Knai C, Brusamento S, Legido-Quigley H, et al.: Systematic review of the methodological quality of clinical guideline development for the management of chronic disease in Europe.
Health Policy 2012;107(2–3):157–67
9. Gagliardi AR, Brouwers MC: Do guidelines offer implementation advice to target users? A systematic review of guideline applicability.
BMJ Open 2015;5:e007047
10. Armstrong JJ, Goldfarb AM, Instrum RS, et al.: Improvement evident but still necessary in clinical practice guideline quality: a systematic review.
J Clin Epidemiol 2017;81:13–21
11. Rabassa M, Garcia-Ribera Ruiz S, Solà I, et al.: Nutrition guidelines vary widely in methodological quality: an overview of reviews.
J Clin Epidemiol 2018;104:62–72
12. Dijkers MP, Ward I, Annaswamy T, et al.: Quality of
rehabilitation clinical practice guidelines: an overview study of AGREE II appraisals.
Arch Phys Med Rehabil 2020;101:1643–55
13. Hoffmann-Esser W, Siering U, Neugebauer EAM, et al.: Guideline appraisal with AGREE II: online survey of the potential influence of AGREE II items on overall assessment of guideline quality and recommendation for use.
BMC Health Serv Res 2018;18:143
14. Hatakeyama Y, Seto K, Amin R, et al.: The structure of the quality of clinical practice guidelines with the items and overall assessment in AGREE II: a regression analysis.
BMC Health Serv Res 2019;19:788
15. Levack WMM, Rathore FA, Pollet J, et al.: One in 11 Cochrane reviews are on
rehabilitation interventions, according to pragmatic inclusion criteria developed by Cochrane
Rehabilitation .
Arch Phys Med Rehabil 2019;100:1492–8
16. Hoffmann-Eßer W, Siering U, Neugebauer EA, et al.: Guideline appraisal with AGREE II: systematic review of the current evidence on how users handle the 2 overall assessments.
PLoS One 2017;12:e0174831
17. Andrade R, Pereira R, van Cingel R, et al.: How should clinicians rehabilitate patients after ACL reconstruction? A systematic review of clinical practice guidelines (CPGs) with a focus on quality appraisal (AGREE II).
Br J Sports Med 2020;54:512–9
18. Anwer MA, Al-Fahed OB, Arif SI, et al.: Quality assessment of recent evidence-based clinical practice guidelines for management of type 2 diabetes mellitus in adults using the AGREE II instrument.
J Eval Clin Pract 2018;24:166–72
19. Appenteng R, Nelp T, Abdelgadir J, et al.: A systematic review and quality analysis of pediatric traumatic brain injury clinical practice guidelines.
PLoS One 2018;13:e0201550
20. Bhatt M, Nahari A, Wang PW, et al.: The quality of clinical practice guidelines for management of pediatric type 2 diabetes mellitus: a systematic review using the AGREE II instrument.
Syst Rev 2018;7:193
21. Boaden E, Nightingale J, Bradbury C, et al.: Clinical practice guidelines for videofluoroscopic swallowing studies: A systematic review.
Radiography (Lond) 2020;26:154–62
22. Bragge P, Guy S, Boulet M, et al.: A systematic review of the content and quality of clinical practice guidelines for management of the neurogenic bladder following spinal cord injury.
Spinal Cord 2019;57:540–9
23. Bravo-Balado A, Plata M, Trujillo CG, et al.: Is the development of clinical practice guidelines for non-neurogenic overactive bladder trustworthy? A critical appraisal using the Appraisal of Guidelines, Research and Evaluation (AGREE) II instrument.
BJU Int 2019;123:921–2
24. Coronado-Zarco R, Olascoaga-Gómez de León A, García-Lara A, et al.: Nonpharmacological interventions for osteoporosis treatment: systematic review of clinical practice guidelines.
Osteoporos Sarcopenia 2019;5:69–77
25. Filiatreault S, Hodgins M, Witherspoon R: An umbrella review of clinical practice guidelines for the management of patients with hip fractures and a synthesis of recommendations for the pre-operative period.
J Adv Nurs 2018;74:1278–88
26. Gagliardi AR, Green C, Dunn S, et al.: How do and could clinical guidelines support patient-centred care for women: content analysis of guidelines.
PLoS One 2019;14:e0224507
27. Grammatikopoulou MG, Theodoridis X, Gkiouras K, et al.: AGREEing on guidelines for nutrition management of adult severe burn patients.
JPEN J Parenter Enteral Nutr 2019;43:490–6
28. Green T, Willson G, Martin D, et al.: What is the quality of clinical practice guidelines for the treatment of acute lateral ankle ligament sprains in adults? A systematic review.
BMC Musculoskelet Disord 2019;20:394
29. Herzig SJ, Calcaterra SL, Mosher HJ, et al.: Safe opioid prescribing for acute noncancer pain in hospitalized adults: a systematic review of existing guidelines.
J Hosp Med 2018;13:256–62
30. Hoedl M, Schoberer D, Halfens RJG, et al.: Adaptation of evidence-based guideline recommendations to address urinary incontinence in nursing home residents according to the ADAPTE-process.
J Clin Nurs 2018;27(15–16):2974–83
31. Hoydonckx Y, Kumar P, Flamer D, et al.: Quality of chronic pain interventional treatment guidelines from pain societies: assessment with the AGREE II instrument.
Eur J Pain 2020;24:704–21
32. Irajpour A, Hashemi M, Taleghani F: The quality of guidelines on the end-of-life care: a systematic quality appraisal using AGREE II instrument.
Support Care Cancer 2020;28:1555–61
33. Jaggi A, Drake M, Siddiqui E, et al.: A critical appraisal of the principal guidelines for neurogenic lower urinary tract dysfunction using the AGREE II instrument.
NeurourolUrodyn 2018;37:2945–50
34. Jolliffe L, Lannin NA, Cadilhac DA, et al.: Systematic review of clinical practice guidelines to identify recommendations for
rehabilitation after stroke and other acquired brain injuries.
BMJ Open 2018;8:e018791
35. Karimi T, Bahrami M, Yadegarfar G: The critical assessment of the quality of common clinical guidelines for administering chemotherapy drugs by using AGREE II tool.
Int J Cancer Manag 2019;12:410–6
36. Kim WJ, Novotna K, Amatya B, et al.: Clinical practice guidelines for the management of brain tumours: a
rehabilitation perspective.
J Rehabil Med 2019;51:89–96
37. Kiriakova V, Cooray SD, Yeganeh L, et al.: Management of bone health in women with premature ovarian insufficiency: systematic appraisal of clinical practice guidelines and algorithm development.
Maturitas 2019;128:70–80
38. Knight S, Takagi M, Fisher E, et al.: A systematic critical appraisal of evidence-based clinical practice guidelines for the
rehabilitation of children with moderate or severe acquired brain injury.
Arch Phys Med Rehabil 2019;100:711–23
39. Lee SY, Amatya B, Judson R, et al.: Clinical practice guidelines for
rehabilitation in traumatic brain injury: a critical appraisal.
Brain Inj 2019;33:1263–71
40. Lin I, Wiles LK, Waller R, et al.: Poor overall quality of clinical practice guidelines for musculoskeletal pain: a systematic review.
Br J Sports Med 2018;52:337–43
41. Mandl L, Schindel D, Deutschbein J, et al.: Quality of German-language guidelines for post-stroke
rehabilitation of aphasia and dysarthria - results of a systematic review and of an international comparison.
Rehabilitation (Stuttg) 2019;58:331–8
42. O’Sullivan JW, Albasri A, Koshiaris C, et al.: Diagnostic test guidelines based on high-quality evidence had greater rates of adherence: a meta-epidemiological study.
J Clin Epidemiol 2018;103:40–50
43. Parikh P, Santaguida P, Macdermid J, et al.: Comparison of CPG’s for the diagnosis, prognosis and management of non-specific neck pain: a systematic review.
BMC Musculoskelet Disord 2019;20:81
44. Pattuwage L, Olver J, Martin C, et al.: Management of spasticity in moderate and severe traumatic brain injury: evaluation of clinical practice guidelines.
J Head Trauma Rehabil 2017;32:E1–12
45. Perez-Panero AJ, Ruiz-Munoz M, Cuesta-Vargas AI, et al.: Prevention, assessment, diagnosis and management of diabetic foot based on clinical practice guidelines: a systematic review.
Medicine (Baltimore) 2019;98:e16877
46. Reis ECD, Passos SRL, Santos M: Quality assessment of clinical guidelines for the treatment of obesity in adults: application of the AGREE II instrument.
Cad Saude Publica 2018;34:e00050517
47. Sankah BEA, Stokes M, Adams J: Exercises for hand osteoarthritis: a systematic review of clinical practice guidelines and consensus recommendations.
Phys Ther Rev 2019;24(3–4):66–81
48. Shallwani SM, King J, Thomas R, et al.: Methodological quality of clinical practice guidelines with physical activity recommendations for people diagnosed with cancer: a systematic critical appraisal using the AGREE II tool.
PLoS One 2019;14:e0214846
49. Shetty K, Raaen L, Khodyakov D, et al.: Evaluation of the Work Loss Data Institute’s Official Disability guidelines.
J Occup Environ Med 2018;60:e146–51
50. Tamas G, Abrantes C, Valadas A, et al.: Quality and reporting of guidelines on the diagnosis and management of dystonia.
Eur J Neurol 2018;25:275–83
51. Tan MKH, Luo R, Onida S, et al.: Venous leg ulcer clinical practice guidelines: what is AGREEd?
Eur J Vasc Endovasc Surg 2019;57:121–9
52. Uzeloto JS, Moseley AM, Elkins MR, et al.: The quality of clinical practice guidelines for chronic respiratory diseases and the reliability of the AGREE II: an observational study.
Physiotherapy 2017;103:439–45
53. van der Ploeg MA, Floriani C, Achterberg WP, et al.: Recommendations for (discontinuation of) statin treatment in older adults: review of guidelines.
J Am Geriatr Soc 2019;30:30
54. Wang Y, Li H, Wei H, et al.: Assessment of the quality and content of clinical practice guidelines for post-stroke
rehabilitation of aphasia.
Medicine (Baltimore) 2019;98:e16629
55. Zhang P, Lu Q, Li H, et al.: The quality of guidelines for diabetic foot ulcers: a critical appraisal using the AGREE II instrument.
PLoS One 2019;14:e0217555
56. Zhao XH, Yang T, Ma XD, et al.: Heterogeneity of nutrition care procedures in nutrition guidelines for cancer patients.
Clin Nutr 2020;39:1692–704
57. Gagliardi AR, Brouwers MC: Integrating guideline development and implementation: analysis of guideline development manual instructions for generating implementation advice.
Implement Sci 2012;7:67
58. Schunemann HJ, Wiercioch W, Etxeandia I, et al.: Guidelines 2.0: systematic development of a comprehensive checklist for a successful guideline enterprise.
CMAJ 2014;186:E123–42
59. Burgers JS: Guideline quality and guideline content: are they related?
Clin Chem 2006;52:3–4
60. Watine J, Friedberg B, Nagy E, et al.: Conflict between guideline methodologic quality and recommendation validity: a potential problem for practitioners.
Clin Chem 2006;52:65–72
61. Matthys J, De Meyere M: Quality evidence important for quality guidelines.
CMAJ 2010;182:1449–50
62. Eikermann M, Holzmann N, Siering U, et al.: Tools for assessing the content of guidelines are needed to enable their effective use—a systematic comparison.
BMC Res Notes 2014;7:853
63. Vlayen J, Aertgeerts B, Hannes K, et al.: A systematic review of appraisal tools for clinical practice guidelines: multiple similarities and one common deficit.
Int J Qual Health Care 2005;17:235–42