2. What the literature says: translating guidelines into practice

Dave Davis, MD; Anne Taylor-Vaisey, MLS

In this review, we focus on the aspect of the CPG process that attempts to ensure timely adoption of the guidelines by practising clinicians in a way that optimizes the health of their patients and communities. We also emphasize reappraisal and measurement of the effect of guidelines on clinical practice and health care outcomes.

We explore particularly the conceptual and theoretical bases for understanding how, why and in what circumstances health professionals adopt new information and change their practices. We describe and characterize these concepts to facilitate retrieval of information by a focused literature search and present the results of the search, clustering them along the lines of the theoretical forces that seem to affect adoption of innovation. Finally, we provide recommendations and suggestions for professional organizations and others interested in implementing guidelines to improve health care delivery and the results of that care.

Definitions

Academic detailing (also called educational outreach): education of an individual physician by a pharmacist or other health professional, usually in the physician's office and most often in the area of prescribing

Adoption: health care providers' commitment and decision to change their practice; the actual change in practice

Consumers: patients and the public

Diffusion: distribution of information and practitioners' natural, unaided adoption of policies and practices

Dissemination: communication of information to clinicians to improve their knowledge or skills; more active than diffusion, dissemination targets a specific clinical audience

Educational interventions: any strategy, program or manoeuvre intended to persuade physicians to change their performance and maintain their competence

Guidelines, clinical practice guidelines: systematically developed statements about specific clinical problems to assist practitioners and patients in making decisions about appropriate health care

Implementation: putting a guideline in place; more active than dissemination, it involves effective communication strategies and identifies and overcomes barriers by using administrative and educational techniques that are effective in the practice setting

Opinion leaders or influential educational professionals: most often people identified by their colleagues as respected clinicians and effective communicators

Providers: health care professionals, including physicians; in some instances, also nonprofessionals such as office staff

Setting: the practice site -- not so much its location, although possibly important, as its type -- whether solo, community-based family practice office, an ambulatory care department of a teaching hospital, an emergency room of a community hospital, etc; the setting may also imply, but not define, aspects of workload, relevant health care team members, mix of patients, and funding mechanisms

Background

Prior CMA conferences on guidelines

Acknowledging the significant role that quality-of-care initiatives, especially CPGs, may play in Canadian health care, the CMA established a Quality of Care Committee in 1990, then facilitated establishment of the NAPAQH¹² involving the CMA, the Association of Canadian Medical Colleges, the Federation of Medical Licensing Authorities of Canada, the Royal College of Physicians and Surgeons of Canada, the College of Family Physicians of Canada and the Canadian Council on Health Services Accreditation. This initiative led to 2 major consensus conferences. The specific goals of the conferences and the more general aims of the NAPAQH include promotion of the acceptance of evidence-based care, coordination and facilitation of the guideline movement and development of a process to monitor, evaluate and improve CPGs.¹²

A November 1992 workshop addressed several major issues of relevance to the guideline movement: ethical and legal implications, methods of guideline development and strategies for implementation. Participants identified 4 major action steps: promulgation of a definition of quality that incorporated the process and outcome of care; planning a subsequent workshop to outline practical methods for developing CPGs; establishment of a network of guideline developers; and development and maintenance of an up-to-date database of CPGs.¹³

The CMA and NAPAQH organized a second major conference in 1994. It addressed 5 major issues: roles of member organizations; establishment of priorities in the development of guidelines; dissemination and implementation of guidelines; evaluation of their effectiveness in promoting optimum health care outcomes; and articulation of the structure and function of a Canadian CPG network.¹⁴

Of the main issues arising from these conferences, several are notable: the role of organizations in CPG development;^14,15 the need for coordination¹⁶ and ranking of areas requiring CPGs in order of priority;¹⁷ the place of CPGs in clinical practice;¹⁸ and their evaluation.¹⁹

Development and implementation of guidelines

The production and dissemination of CPGs has several components (Table 1).^20­24 These steps reflect earlier efforts at development of the CPG process and do not focus on dissemination strategies.

First, a local group or, more often, a national body chooses a clinical area in which there is demonstrated need. This decision may include selecting and ranking a number of clinical problems and framing the problem so that outcomes may be analysed and discussed.

Second, data are gathered from research and relevant practice patterns either by searching the literature (including searching for existing guidelines) then collating and weighting the resulting trials or studies on the strength of their evidence, or by developing consensus through conferences or other means such as modified Delphi or nominal group techniques.²⁵ Achieving consensus often refines the more objective, evidence-based literature-searching process by adding modifying or modulating factors, practical issues and, occasionally, minority opinions.

Third, the information is further reviewed and appraised, distilled and collated as recognizable guidelines, that is, recommendations about strategies for investigation and management.

Fourth, the sponsoring and other interested organizations endorse the guidelines. This step is often called adoption -- not to be confused with the adoption that reflects clinicians' performance.

Fifth, CPGs are disseminated, usually by traditional means, such as mailing the recommendations and guidelines to members in separate monographs or papers or publishing them in recognized professional clinical journals.

Sixth, various groups or individual practitioners may attempt to implement the guidelines more actively. This may be done through various, often multiple strategies designed to assist, convince, coerce or otherwise influence physicians, patients and their caregivers to translate the guidelines into practice.

Finally, the guidelines are subjected, albeit irregularly, to reappraisal, evaluation and reiteration of the process.

This review focuses on the sixth step, which attempts to ensure translation of CPGs into practice.

Theoretical models of physician change

Specific information about clinicians' adoption of guidelines, medical information or innovations in general arises from 2 main theory bases related to the "learner/practitioner" and the "guideline disseminator" in a complex health care system.

The learner/practitioner: Two types of studies have elucidated how clinicians learn and change as they attempt to keep their practice up to date: qualitative studies that ask what forces have caused clinicians to change specific clinical procedures or practices and how they learned^26,27 and sociometric analysis of the adoption of innovation.^28,29

Several clusters of forces or factors appear to drive the clinical change process.

• External forces, which include societal values and customs, political influences (professional and governmental) including financial and regulatory issues
• Factors integral to the practice, such as patient needs, characteristics and demands, and practice location
• Internal or personal forces, such as motivation, professionalism and desire for competence

The guideline disseminator: Studies from the perspective of the organization that provides the guidelines bear many similarities to studies of the effectiveness of continuing medical education (CME) delivery methods, including mailed materials, academic detailing and the more traditional conferences and symposia. Reviews or meta-analytic studies^30­35 indicate that, when used alone, dissemination strategies such as didactic lectures or unsolicited, mailed materials generally fail to change physicians' performance or health care outcomes. However, these methods do work when coupled with reinforcing strategies such as manual or computerized reminder systems, audit and feedback methods, or practice-enabling strategies such as patient-education materials or easy-to-follow flow sheets.

Methods

The answers are mixed. Grimshaw and Russell³⁶ noted that 55 of 59 published assessments of CPGs reported statistically significant improvements in the process of care (i.e., changes in health professional performance). A further 9 of 11 studies demonstrated a significant improvement in health care outcomes. For example, Hoey and colleagues³⁷ reported a positive effect of guidelines on physicians' use of benzodiazepines in the management of alcohol withdrawal in hospital.

However, the results of the 55 studies were variable, often weak or positive in only 1 of several possible outcomes. In addition, positive outcomes often reflected the intensity of the intervention; the use of information-only approaches resulted in less change than more complex interventions.

Studies conducted after the release of guidelines have often demonstrated that practitioners had less than satisfactory awareness or compliance with them. For example, a survey of New Zealand physicians related to the management of hypertension demonstrated that only 40% had read the guideline.³⁸ In the United States, a chart review of diabetic patients revealed major deficiencies in care following the release of the American Diabetes Association standards of care except in 3 areas: foot care, eye care and lipid screening.³⁹ Cline and colleagues⁴⁰ observed noncompliance with advanced cardiac life support guidelines in more than one-third of cases, despite biannual training of the providers.

Physicians often report adherence to guidelines, but further probing indicates relatively poor understanding of or actual compliance with them. For example, Rosser⁴¹ surveyed Ontario family physicians about their knowledge of lipid-lowering guidelines. Although 78% of physicians indicated that they complied with the guidelines, further questioning revealed that only 5% of respondents actually followed them. In New Zealand, lipid levels in at-risk cardiac patients did not change after the release of guidelines on dyslipidemia.⁴² Finally, in British Columbia, Smith and Herbert⁴³ reported incomplete compliance with preventive CPGs, which recommended that various screening steps not be used.

The findings of the literature review may be clustered into 2 broad areas: those exploring the variables affecting physicians' adoption of CPGs in a naturalistic manner, and those describing outcomes of trials of educational interventions to change physicians' behaviour or health care outcomes.

Natural diffusion: what variables affect adoption of guidelines?

In addition to the research described earlier, we found several articles that further developed theoretical constructs. These explore the variables that impede or facilitate adoption of innovation or medical information (Table 2).

Qualities of the guidelines

Rogers²⁸ described the qualities of the guideline or innovation itself; namely its complexity, "observability," "trialability" and cost, among other factors. Refining these concepts later, he outlined 5 major attributes of innovations that affect their rate of adoption (Table 3).⁴⁴ Validating this research, Grilli and Lomas⁴⁵ reviewed 23 trials measuring the effectiveness of guideline dissemination and found more effective adoption of guidelines that were relatively uncomplicated and could be observed or tried by the clinician. Weingarten⁴⁶ further elaborated characteristics of the innovation. The clinical nature or content of the guideline has also been studied.

Characteristics of the health professional

Several authors have described characteristics of the physician or health professional that affect guideline adoption.^38,47­51 They mention demographic variables, particularly age, as factors. For example, Ferrier and coworkers⁵⁰ found that young Ontario medical graduates viewed the concept of CPGs more favourably than their colleagues in the United States; however, the authors caution against interpretation of these results based solely on age. Country of origin and its attitudes toward health care were also possible factors. Tunis and colleagues³ noted that, although internists recognized the potential merit of American College of Physicians guidelines, they had serious concerns about their effects on clinical autonomy, satisfaction with practice and health care costs.

Rogers⁴⁴ describes 5 stages of innovation­diffusion from the perspective of the provider:

• Knowledge of the CPG: competence
• Persuasion: forming a favourable attitude toward it
• Decision to act on it
• Implementation: putting the CPG into practice
• Confirmation: seeking further information before continuing to adopt the guideline or stop.

An attempt to improve physicians' attitudes by having them develop their own guidelines has been described by Wachtel and O'Sullivan.⁵² They recruited a group of hospital physicians to develop guidelines for test ordering. The intervention group exhibited a nonsignificant tendency to reduce test ordering more than the control group. However, the latter were nonvolunteers and were also more frequent test orderers. A similar study among maritime physicians also demonstrated no significant improvement.⁵³

Characteristics of the practice setting

Stobberingh and coworkers⁵⁴ studied the role of hospital formularies in prescribing practices. Albrecht and Lee⁵⁵ describe the successful implementation of guidelines in a public clinic. Another study⁵⁶ shows that guidelines related to breast cancer surgery and chemotherapy were adopted more successfully in a teaching hospital than in a community hospital. Ellrodt and colleagues⁵⁷ reviewed the failure of guidelines to reduce hospital stay of patients with chest pain; they concluded that system inefficiency and issues of implementation were factors. Computer-facilitated strategies have demonstrated considerable effectiveness in the implementation of guidelines.

Conroyand Shannon⁵⁸ considered the practice environment in their exploration of the role of social influence. They describe a model in which factors such as habit and custom, beliefs of peers and social norms appear to be major determinants of physicians' behaviour. Although new information may be readily available in practice settings and providers may be aware of this information, the authors state that adoption of new practices is very much a product of social influence.

Incentives

Incentives may be related to legal or malpractice issues^23,59,60 or financial issues (methods of overall physician compensation or reimbursement for particular procedures). Jutras⁶⁰ argued that, although CPGs potentially assume legal and regulatory proportions and, thus, act to enforce (albeit against resistance by many clinicians) or ensure compliance, this outcome is unlikely "even on the assumption that practice guidelines are taken as the legal standard of care, the standard will likely be flexible enough to allow for [interpretation] and debate." Robinson⁶¹ reported that, although few trials employ financial incentives to effect outcomes, many "naturalistic experiments" confirm the effect of compensation on clinical behaviour.^62,63 Funding may also be related to payment policies. In the United States, third-party payers have been observed to apply guidelines (especially those focusing on evidence of efficacy and safety) to decisions about payment to physicians or patients.⁶⁴

Regulation by accreditation or licensing bodies

On one hand, the need for potential guidelines (termed "cookbook" medicine by some) has been denigrated by Hirshfield⁶⁵ in articulating the American Medical Association's opposition to guideline adoption. On the other hand, medical regulatory bodies have displayed their ability to effect adoption of CPGs.⁶² Adherence to guideline standards may be made the basis of accreditation for hospitals as well; in the United States, the Joint Commission on the Accreditation of Healthcare Organizations has selected some CPG-based measures -- for example, the rate of cesarean section after vaginal birth -- to assist in the accreditation process.⁶⁴

Patient factors

The final element is the patient -- either individual demands and clinical problems or population perspectives. In a study of antibiotic prescribing, recommendations for prophylaxis were more often followed in children than in adults.⁶⁶ In another study, CPG protocols were not followed in specific populations of gastroenterologists' patients.⁶⁷

Results of intervention trials: specific strategies that facilitate implementation of CPGs

Review articles

Several reviews of the educational intervention literature were retrieved.^30­35 We selected the 3 most recent for analysis. The first³³ stresses the theoretical base on which CME methods seem to be most effective in changing physicians' performance or health care outcomes: those that predispose to change by disseminating information and improving knowledge, skills or attitudes, i.e., the competencies of providers; those that enable or facilitate adoption in the practice setting, i.e., by making the practice environment more conducive to change by setting up recall systems to improve preventive practices, for example; and those that reinforce a change, e.g., audit and feedback.

Authors of another review³⁴ stress the importance of needs assessment -- the process of determining the gap between ideal and actual performance and aiming the educational intervention at the specific gap or need. When change in provider performance or health care (patient) outcome is measured, the impact of these interventions generally falls in the following range:

• Weak interventions: didactic lecture-based CME, e.g., conferences, seminars; mailed, unsolicited materials
• Moderately effective interventions: audit and feedback, especially if done concurrently, directed at specific providers and delivered by peers or opinion leaders
• Relatively potent interventions: reminder systems, academic detailing, multiple interventions.

The most recent review³⁵ delineates more clearly and categorizes the methods of CME delivery. This taxonomy is currently the one employed by the Cochrane Collaboration on Effective Clinical Practice.⁶⁸ It is used as the template for appraising the results of trials of specific educational interventions.

Trials examining traditional CME methods

Educational materials: Describing a trial that employed mailed materials (an introductory letter and radiographic guidelines), Oakeshott and colleagues⁶⁹ demonstrated a positive effect on the ordering of roentgenograms by general practitioners in the United Kingdom. In a less positive study, Stollar³⁹ assessed the impact of the widely circulated American Diabetes Association guidelines on patient management by endocrine fellows at 42 academic institutions. Chart review revealed poor compliance, with certain exceptions. Smith and Herbert⁴³ also reported poor compliance with previously published and distributed preventive practice guidelines.

Formal CME conferences, workshops: Often referred to as CME, formal conference courses, symposia, workshops and small-group discussions are among the most common methods for physicians to continue their learning. Several examples have demonstrated their role in the CPG dissemination process. Using a small-group process, Karuza and coworkers⁷⁰ displayed by chart review an increased rate of influenza vaccination for the elderly. However, supporting others' findings^15,35 that formal CME fails to effect physician performance change, Browner and colleagues⁷¹ found little or no improvement in cholesterol management after a 3-hour seminar, even when it was enhanced by follow-up meetings and printed material. Although evidence is still anecdotal, there is growing empirical support for small-group CME activities that incorporate opportunities for peer-group sharing and discussing standard information (e.g., CPGs). At least in theory, such groups have a strong influence on providers' behaviour and may well do more than larger group sessions in changing performance.^72,73 They may also permit observation of guideline adoption by others.

Community-based interventions

Academic detailing: Nardella and coworkers⁷⁴ used a modification of the academic detailer; they had study investigators meet with and persuade surgeons to reduce their use of peri-operative laboratory investigation. Although the educational effort was extensive, the authors reported a significant reduction in test ordering and a substantial cost saving. Further studies using academic detailing are documented under multiple interventions below.

Opinion leaders and influential clinicians: In their study of the effectiveness of guidelines for vaginal birth after cesarean section, Lomas and colleagues⁷⁵ demonstrated the effectiveness of promoting these guidelines at the local hospital level by training and deploying community-based opinion leaders -- educationally influential and respected clinicians identified by their own colleagues. Others^76­78 have also demonstrated the influence of opinion leaders, although the effect was neither consistent nor strong; these trials predated the CPG movement. The opinion leader may effect changes in the natural adoption process, perhaps by improving the ability of community-based colleagues to observe or try innovations or guideline-recommended practices.

Practice-based interventions

Patient-based interventions: Several patient-centred educational interventions, especially those employing patient education materials, were reported to be effective in the management of diabetes,⁷⁹ the incorporation of preventive strategies⁸⁰ and smoking cessation⁸¹ often in conjunction with other, physician-centred strategies. In a specific guideline-related trial, Katon and coworkers⁸² described an intervention that aided the implementation of CPGs in the management of depression through methods including the creation of patient-education materials; it increased the number of physicians' visits with patients and patients' compliance with medication.

Audit and feedback: Reviews of CME^34,35 have indicated a mixed effect of audit and feedback methods on physicians behaviour. This was confirmed by Robinson⁶¹ who suggested that the timing of the feedback is important; when provided concurrently, feedback is more effective than later, retrospective interventions. In a more successful trial, Johnson and colleagues⁸³ reported the effectiveness of provider-specific feedback in reducing the consumption of hospital resources by orthopedic surgeons performing total hip replacement.

Reminders: Dartnell and coworkers⁸⁴ described a successful intervention using posters and pocket-sized laminated cards to augment dissemination of anticoagulation guidelines on hospital wards. Emslie and colleagues⁸⁵ demonstrated that a structured infertility-management reminder sheet improved management of this disorder by general practitioners in the United Kingdom. Many authors have described interventions that embed guidelines into decision-support systems, characterized here as reminders. For example, Pestotnik and colleagues⁸⁶ demonstrated the effectiveness of a computer-assisted discussion support program to disseminate locally produced guidelines to improve antibiotic use, reduce costs and decrease the emergence of antibiotic resistant strains. Others^49,87,88 have demonstrated similar successful interventions in several clinical areas. Weingarten⁸⁹ used feedback along with other interventions in his failed attempt to implement CPGs; however, the nature of the guidelines themselves was problematic.

Multiple-intervention strategies

Educational programs or strategies that use 2 or more interventions appear to have a greater impact on physician behaviour and health care outcomes than single interventions.^34,35,90 These authors describe a guideline-implementation process for primary care physicians using mailed materials, follow-up telephone calls and presentations at meetings. Follow-up meetings of each primary care department were attended by an otolaryngologist who presented findings of a global audit and encouraged ongoing discussion. A subsequent audit demonstrated a significant decrease in inappropriate referrals and improved access by appropriately referred patients. DeSantis and colleagues⁹¹ reported a successful trial of academic detailing in Australia in which a brochure describing appropriate antibiotic prescribing in tonsilitis was mailed to all general practitioners and community pharmacists in a selected region. This was followed by a visit from a project pharmacist and several further mailings. In the United States, Weingarten and coworkers⁹² employed several strategies to reduce the length of stay of patients with chest pain. Two educational conferences were followed by a memo sent to participating physicians, feedback on performance to providers and approval of the guidelines by local opinion leaders who encouraged compliance.

Discussion

This review has focused on the implementation process, i.e., the dissemination of CPGs and the adoption of practice changes promulgated by them. Although our findings may be significant for the continuation of this movement, several cautions must be offered. First, the search process was restrictive rather than inclusive and, thus, may have excluded many articles. Second, effect sizes and comparisons have not been made here, as the units of interventions were seldom comparable. Third, many articles could be classified in more than one area; thus, generalizations made about a particular intervention may be altered by the practice environment in which the study took place, for example.

Nonetheless, clear statements can be made about CPGs and their implementation. They may be characterized as a theoretical or contextual basis for understanding the adoption of CPGs by providers and as a more practical, intervention-based approach to the question of adoption.

A theoretical base for facilitating implementation of guidelines

This review of guideline implementation echoes its many predecessors.^6,22,58,93 It is necessary to consider the adoption of any innovation or the dissemination of new medical knowledge in a holistic, contextual manner. Although the practice of medicine may be altered by interventions, such as educationally influential clinicians or academic detailing, a host of other factors also play a role -- from factors internal to the health care provider to larger issues such as social and cultural forces.

These forces and variables are illustrated in Figure 2. Three large areas of influence on physician acceptance of and compliance with CPGs are represented by the circles.(26) They represent large social and political forces, such as social norms and professional regulations; environmental considerations, such as practice location, demographics, setting and patient issues; and intraprovider issues such as motivation, age and attitudes. There are major areas of overlap in these forces. Rectangles show the stages of guideline development and implementation.

It seems clear that, to be successfully implemented, any guideline must include strategies to facilitate its adoption. Thus, a consideration of the nature of the guideline itself, the nature and beliefs of the physicians at whom the CPG is directed, factors in the environment that can facilitate or impede its adoption and other proactive interventions appear to be necessary ingredients in the translation of CPGs into improved performance or health care outcomes.

Design and implementation of specific guideline adoption strategies

In the design of interventions, it appears necessary to view the dissemination­adoption process (i.e., implementation) as having at least 2 stages:

• The primary dissemination strategy, usually akin to the mass-media approach, in which a common baseline of information is available to as many health professionals as possible and
• The elements, which may be called "secondary" or implementation strategies, that enable or reinforce the change in the practice setting.

Although several interventions appear to be effective, more consistently positive results appear to come from trials of practice-based strategies such as concurrent (increasingly computerized) reminders or community-based interventions such as academic detailing. Multiple interventions often work at both levels and possibly account for their success.

Strategies to facilitate adoption range from those with a low potential to those with a high likelihood of success (Table 4). Adapted in part from Grimshaw and Russell,³⁶ the table alludes to the influence on adoption of the extent to which the CPG has been developed by the physicians who will use it. Although such a relation appears valid, evidence that there is automatic low acceptance of guidelines developed elsewhere, for example, by large national bodies, compared with those developed internally or locally, is weak, indicating the existence of other enablers.

A pre-intervention phase also appears to be important in determining objectively and subjectively that needs exist in the area targeted by the guideline. These needs may be of several types, including the expressed or perceived needs of the learner and those of the practice and patient.

Organizational issues

Although evidence on dissemination and adoption of CPGs is relatively clear, it is far less apparent who will undertake development of the necessary interventions, with what coordination and funding and by what means. The need for the coordination of data sources to determine practice patterns and needs, professional associations interested in CPG development, hospitals, CME providers and patient or health care provider groups is clear and awaits leadership and direction.

As a small example of the potential for such linkages, Dodek and Ottoson⁹⁴ propose integration of CPG dissemination and implementation strategies with CME programming. They believe that such integration would provide a platform for the earliest dissemination strategies related to CPGs, permit a variety of "take-home" strategies to reinforce and enable implementation of the CPGs and offer an opportunity for evaluation of outcomes. However, this type of integration calls for closer working relations between medical school providers of CME, specialty societies and guideline developers.

A similar integration of efforts of journal publishers and guideline producers is called for in light of the relatively small effect that unsolicited mailed materials appear to have on physicians' performance. Whether such materials, including journals, predispose to change in ways not fully understood has been discussed by Davis and colleagues.⁹⁵ Integrating journal publication policy with the needs of guideline developers, establishing reminders or practice enablers (e.g., accompanying patient information material) and using more informative and structured abstracts⁹⁶ may help physicians to assess the relevance, importance and validity of the guideline in a regular and timely fashion.

Conclusions: past experience, future directions

The reasons for this failure are increasingly clear. They involve an understanding of the degree to which a large number of forces or variables influence the practice of health care providers and evidence regarding the interventions or strategies that do affect providers' performance. Much research remains to be done. Primary dissemination strategies clearly need to be buttressed by secondary, effective implementation and education methods, which must be more practice- and community-based than those traditionally encompassed by CME. Such methods and strategies will be enhanced by the availability of clinical practice and outcomes data, new dissemination strategies (e.g., Internet), practice-linked strategies, such as computer-generated reminders and increased linkages with broadly defined CME and CME providers. Furthermore, an enhanced understanding of the contextual influences that affect performance modification may lead to further development of community-based strategies such as the use of opinion leaders.

Finally, it is clear that creating guidelines without paying significant attention to their adoption is a sterile exercise. At worst, it is a waste of precious intellectual and human resources. At best, when it is augmented by appropriate implementation strategies, it can reduce inappropriate practice variability and improve the practices of Canadian physicians and the health of their patients.