Béatrice Fervers

AGREE II: advancing guideline development, reporting and evaluation in health care

Clinical practice guidelines, which are systematically developed statements aimed at helping people make clinical, policy-related and system-related decisions,[1][1],[2][2] frequently vary widely in quality.[3][3],[4][4] A strategy was needed to differentiate among guidelines and ensure that those

Development of the AGREE II, part 1: performance, usefulness and areas for improvement

Background: We undertook research to improve the AGREE instrument, a tool used to evaluate guidelines. We tested a new seven-point scale, evaluated the usefulness of the original items in the instrument, investigated evidence to support shorter, tailored versions of the tool, and identified areas for improvement. Method: We report on one component of a larger study that used a mixed design with four factors (user type, clinical topic, guideline and condition). For the analysis reported in this article, we asked participants to read a guideline and use the AGREE items to evaluate it based on a seven-point scale, to complete three outcome measures related to adoption of the guideline, and to provide feedback on the instrument’s usefulness and how to improve it. Results: Guideline developers gave lower-quality ratings than did clinicians or policy-makers. Five of six domains were significant predictors of participants’ outcome measures (p < 0.05). All domains and items were rated as useful by stakeholders (mean scores > 4.0) with no significant differences by user type (p > 0.05). Internal consistency ranged between 0.64 and 0.89. Inter-rater reliability was satisfactory. We received feedback on how to improve the instrument. Interpretation: Quality ratings of the AGREE domains were significant predictors of outcome measures associated with guideline adoption: guideline endorsements, overall intentions to use guidelines, and overall quality of guidelines. All AGREE items were assessed as useful in determining whether a participant would use a guideline. No clusters of items were found more useful by some users than others. The measurement properties of the seven-point scale were promising. These data contributed to the refinements and release of the AGREE II.

Development of the AGREE II, part 2: assessment of validity of items and tools to support application.

Background: We established a program of research to improve the development, reporting and evaluation of practice guidelines. We assessed the construct validity of the items and user’s manual in the β version of the AGREE II. Methods: We designed guideline excerpts reflecting high-and low-quality guideline content for 21 of the 23 items in the tool. We designed two study packages so that one low-quality and one high-quality version of each item were randomly assigned to each package. We randomly assigned 30 participants to one of the two packages. Participants reviewed and rated the guideline content according to the instructions of the user’s manual and completed a survey assessing the manual. Results: In all cases, content designed to be of high quality was rated higher than low-quality content; in 18 of 21 cases, the differences were significant (p < 0.05). The manual was rated by participants as appropriate, easy to use, and helpful in differentiating guidelines of varying quality, with all scores above the mid-point of the seven-point scale. Considerable feedback was offered on how the items and manual of the β-AGREE II could be improved. Interpretation: The validity of the items was established and the user’s manual was rated as highly useful by users. We used these results and those of our study presented in part 1 to modify the items and user’s manual. We recommend AGREE II (available at www.agreetrust.org) as the revised standard for guideline development, reporting and evaluation.

Adapting clinical practice guidelines to local context and assessing barriers to their use

The knowledge-to-action cycle represents a framework for the implementation of knowledge. [1][1] As discussed in the first article in this series, the action phases of this cycle were derived from a review of 31 theories of planned action. [2][2] Included in this cycle ([Figure 1][3]) are the

International Assessment of the Quality of Clinical Practice Guidelines in Oncology Using the Appraisal of Guidelines and Research and Evaluation Instrument

PURPOSE To describe the quality of oncology guidelines developed in different countries. METHODS The Appraisal of Guidelines and Research and Evaluation (AGREE) Instrument was used to assess the quality of 100 guidelines (including 32 oncology guidelines) from 13 countries. The criteria of the instrument are grouped into six quality domains: scope and purpose, stakeholder involvement, rigor of development, clarity and presentation, applicability, and editorial independence. RESULTS Oncology guidelines had significantly higher scores on rigor of development than nononcology guidelines (42.2% v 29.4%; P =.02). In particular, systematic methods to search for evidence were more often used (P =.01); the methods for formulating the recommendations were more clearly described (P =.02); and health benefits, risks, and side effects were more often considered in formulating the recommendations (P =.03). Although the standardized scores for the other domains were not significantly different, the oncology guidelines had significantly higher scores for items measuring inclusion of all relevant professional groups (P =.05), consideration of patient views (P =.04), and presentation of different options (P =.05). Only three organizations producing oncology guidelines had standardized scores more than 60% for more than three domains. CONCLUSION The quality of clinical practice guidelines (CPGs) is modest in general, but for certain domains, oncology guidelines seem to be of better quality than others. The experience of the organization may explain higher scores for some items. Research projects and training aimed at improving the quality of guidelines should be developed. The AGREE instrument could provide a basis for defining steps in a shared development approach to produce high-quality CPGs.

AGREE II: advancing guideline development, reporting and evaluation in health care.

From McMaster University (Brouwers, Kho, Hanna, Makarski); the Program in Evidence-based Care, Cancer Care Ontario (Brouwers), Hamilton, Ontario; British Columbia Cancer Agency (Browman), Victoria, BC; the Dutch Institute for Healthcare Improvement CBO and IQ Healthcare (Burgers), Radboud University Nijmegen Medical Centre, the Netherlands; St. George’s University of London (Cluzeau), London, UK; the University of Bristol (Feder), Bristol, UK; Unité Cancer et Environement (Fervers), Université de Lyon e Centre Léon Bérard, Université Lyon 1, EA 4129, Lyon, France; the Canadian Institutes of Health Research (Graham), Ottawa, Ontario; the Ottawa Hospital Research Institute (Grimshaw), Ottawa, Ontario; the National Institute for Health and Clinical Excellence (Littlejohns), London, UK; and the Canadian Partnership Against Cancer (Zitzelsberger), Ottawa, Ontario

Patient and public involvement in clinical guidelines: international experiences and future perspectives

Background Clinical practice guidelines (CPG) are important tools for improving patient care. Patient and public involvement is recognised as an essential component of CPG development and implementation. The Guideline International Network Patient and Public Involvement Working Group (G-I-N PUBLIC) aims to support the development, implementation and evaluation of guideline-oriented patient and public involvement programmes (PPIPs). Objective To develop an international practice and research agenda on patient and public involvement in CPG. Method 56 CPG developers, researchers, and patient/public representatives from 14 different countries, were consulted in an international workshop. Recommendations were validated with G-I-N PUBLIC steering committee members. Results Many CPG organisations have set up PPIPs that use a range of participation, consultation and communication methods. Current PPIPs aim to improve the quality and responsiveness of CPGs to public expectations and needs, or to foster individual healthcare decisions. Some organisations use structured involvement methods, including providing training for patient and public representatives. A number of financial, organisational and sociopolitical barriers limit patient and public involvement. The paucity of process and impact evaluations limits our current understanding of the conditions under which patient and public involvement is most likely to be effective. Conclusion Greater international collaboration and research are needed to strengthen existing knowledge, development and evaluation of patient and public involvement in CPG.

Guideline adaptation: an approach to enhance efficiency in guideline development and improve utilisation

Background Developing and updating high-quality guidelines requires substantial time and resources. To reduce duplication of effort and enhance efficiency, we developed a process for guideline adaptation and assessed initial perceptions of its feasibility and usefulness. Methods Based on preliminary developments and empirical studies, a series of meetings with guideline experts were organised to define a process for guideline adaptation (ADAPTE) and to develop a manual and a toolkit made available on a website (http://www.adapte.org). Potential users, guideline developers and implementers, were invited to register and to complete a questionnaire evaluating their perception about the proposed process. Results The ADAPTE process consists of three phases (set-up, adaptation, finalisation), 9 modules and 24 steps. The adaptation phase involves identifying specific clinical questions, searching for, retrieving and assessing available guidelines, and preparing the draft adapted guideline. Among 330 registered individuals (46 countries), 144 completed the questionnaire. A majority found the ADAPTE process clear (78%), comprehensive (69%) and feasible (60%), and the manual useful (79%). However, 21% found the ADAPTE process complex. 44% feared that they will not find appropriate and high-quality source guidelines. Discussion A comprehensive framework for guideline adaptation has been developed to meet the challenges of timely guideline development and implementation. The ADAPTE process generated important interest among guideline developers and implementers. The majority perceived the ADAPTE process to be feasible, useful and leading to improved methodological rigour and guideline quality. However, some de novo development might be needed if no high quality guideline exists for a given topic.

Active and passive cigarette smoking and breast cancer risk: results from the EPIC cohort.

Recent cohort studies suggest that increased breast cancer risks were associated with longer smoking duration, higher pack‐years and a dose‐response relationship with increasing pack‐years of smoking between menarche and first full‐term pregnancy (FFTP). Studies with comprehensive quantitative life‐time measures of passive smoking suggest an association between passive smoking dose and breast cancer risk. We conducted a study within the European Prospective Investigation into Cancer and Nutrition to examine the association between passive and active smoking and risk of invasive breast cancer and possible effect modification by known breast cancer risk factors. Among the 322,988 women eligible for the study, 9,822 developed breast cancer (183,608 women with passive smoking information including 6,264 cases). When compared to women who never smoked and were not being exposed to passive smoking at home or work at the time of study registration, current, former and currently exposed passive smokers were at increased risk of breast cancer (hazard ratios (HR) [95% confidence interval (CI)] 1.16 [1.05–1.28], 1.14 [1.04–1.25] and 1.10 [1.01–1.20], respectively). Analyses exploring associations in different periods of life showed the most important increase in risk with pack‐years from menarche to FFTP (1.73 [1.29–2.32] for every increase of 20 pack‐years) while pack‐years smoked after menopause were associated with a significant decrease in breast cancer risk (HR = 0.53, 95% CI: 0.34–0.82 for every increase of 20 pack‐years). Our results provide an important replication, in the largest cohort to date, that smoking (passively or actively) increases breast cancer risk and that smoking between menarche and FFTP is particularly deleterious.

Testicular cancer incidence to rise by 25% by 2025 in Europe? Model-based predictions in 40 countries using population-based registry data

BACKGROUND Testicular cancer mainly affects White Caucasian populations, accounts for 1% of all male cancers, and is frequently the most common malignancy among young adult men. In light of the escalating rates of testicular cancer incidence in Europe, and in support of future planning to ensure optimal care of patients with what can be a curable disease, we predict the future burden in 40 European countries around 2025. METHODS Current observed trends were extrapolated with the NORDPRED model to estimate the future burden of testicular cancer in the context of changes in risk versus changes in demographics. FINDINGS Despite substantial heterogeneity in the rates, the vast majority of European countries will see an increasing burden over the next two decades. We estimate there will be 23,000 new cases of testicular cancer annually in Europe by 2025, a rise of 24% from 2005. Some of the most rapid increases in testicular cancer are observed in Croatia, Slovenia, Italy and Spain, and a transition is underway, whereby recent attenuations and declines in rates in certain high-risk countries in Northern Europe contrast with the increasing trends and escalating burden in Southern Europe. According to our estimates for 2025, around one in 100 men will be diagnosed with the disease annually in the highest risk countries of Europe (Croatia, Slovenia and Norway). INTERPRETATION Elucidating the key determinants of testicular cancer and the equitable provision of optimal care for patients across Europe are priorities given the steady rise in the number of patients by 2025, and an absence of primary prevention opportunities. FUNDING None.