Personnel: Staffing is the largest expense in most recreation agencies. A professional and productive staff has a direct impact on the efficiency and effectiveness of the organization. Staff evaluations may be conducted mid-year formative or at the end of the year summative. Evaluation of public opinion, cost-benefits, performance based programs, economic impacts, and planning.
Places Areas and Facilities : Evaluations include number of users, safety and legal aspects. Pre-established standards and often used in evaluating provisions for parks based on population carrying capacity , levels of service, and risk management.
Geographic Information Systems GIS now offer unique ways to monitor many types of information related to parks and recreation areas and facilities. Benefit: anything good for a person of a thing. It also relates to a desired condition that is maintained or changed. A benefit also equals and outcome or end result. Programs are not just a bunch of activities that are planned for people. Programs should have a clear purpose and should have identifiable goals.
A quality program results in activities that are designed and implemented to meet certain outcomes that address specific community needs. Value of designing outcomes and quality programs is in using systematic ways to improve the probability that desired outcomes are achieved. Timing of evaluations can profoundly affect the process, as the temporal sequence changes the evaluator's approach. Evaluation may be conducted at the beginning assessment during the process formative or at the end of a program summative.
Assessment examines the type of need and is used for additional planning. It is a process of determining and specifically defining a program, facility, staff member, participant's behavior or administrative process. Needs Assessments - are conducted in a community recreation program and are used to determine the differences between "what is" and "what should be. Formative and summative evaluations may not measure different aspects of recreation, but their results are used in different ways.
Formative evaluation will address organizational objectives efficiency and effectiveness and summative evaluation will address overall performance objectives, outcomes and products. Why - what is the purpose of the project. What - which aspects of the P's will be evaluated. How - how to collect and analyze the data, methods, techniques and ethics.
Systematic formal evaluation requires - education, training, and practical experience. Advantages: knows the organization; requires less time to become familiar with the organization; more accessible to other staff and less intrusive; easier to make changes from the inside.
Disadvantages: more objective; professional commitment to the field not the organization; credibility based on professional experience and competency; more resources and data from other organizations see table on page Politics are the practical wisdom related to the beliefs and biases that individuals and groups hold. Legal issues may arise in evaluations. Make sure your responses are coded and anonymous. Ethical issues deal with issues of right and wrong and professional standards of the profession.
Ethics involve:. Make sure no harm comes to anyone for their participation. People who contribute data have a right to know the results. Moral issues relate to what right or wrong the evaluator may do while conducting a study. Copyright Recreation services are the human service organizations and enterprises related to: parks recreation tourism commercial recreation outdoor recreation education sports therapeutic recreation. Research Evaluation Tries to prove or disprove hypotheses.
Focuses on improvement in areas related to programs, personnel, policies, places and facilities. Focus on increasing understanding or scientific truth. Focus on problem solving and decision making in a specific situation. Applies scientific techniques to testing hypothesis or research questions on findings related to theory.
Evaluation generally compare the results with organization goals to see how well they have been met. Using theory and sampling techniques, should be generalizable to other situations. Not interested in generalizing results to other situations. Research is conducted to develop new knowledge. Evaluation undertaken when a decision needs to be made or the value or worth of something is unknown. Results are not usually shared publicly. What criteria were used to identify these resources?
Each of the selected evidence-based resources has been rated and classified according to the criteria in the rating system. These criteria include:. The rating system does not measure all dimensions of quality. Some other measures that are not included in the rating system are:. Can you define the types of resources displayed?
Systematic Review : A systematic review is a critical assessment and evaluation of all research studies that address a particular issue. Researchers use an organized method of locating, assembling, and evaluating a body of literature on a particular topic using a set of specific criteria.
A systematic review typically includes a description of the findings of the collection of research studies. The systematic review may or may not include a quantitative pooling of data, called a meta-analysis. Nonsystematic Review : A non-systematic review is a critical assessment and evaluation of some but not all research studies that address a particular issue.
Researchers do not use an organized method of locating, assembling, and evaluating a body of literature on a particular topic, possibly using a set of specific criteria. A non-systematic review typically includes a description of the findings of the collection of research studies. The non-systematic review may or may not include a quantitative pooling of data, called a meta-analysis.
Randomized Control Trial : A randomized control trial is a controlled clinical trial that randomly by chance assigns participants to two or more groups. There are various methods to randomize study participants to their groups. Cohort Study : A cohort study is a clinical research study in which people who presently have a certain condition or receive a particular treatment are followed over time and compared with another group of people who are not affected by the condition.
Cross-Sectional or Prevalence Study : A cross-sectional or prevalence study is a study that examines how often or how frequently a disease or condition occurs in a group of people. Prevalence is calculated by dividing the number of people who have the disease or condition by the total number of people in the group.
Case-Control Study : A case-control study identifies all incident cases that develop the outcome of interest and compares their exposure history with the exposure history of controls sampled at random from everyone within the cohort who is still at risk for developing the outcome of interest.
Expert Opinion : The opinion of someone widely recognized as a reliable source of knowledge, technique, or skill whose faculty for judging or deciding rightly, justly, or wisely is accorded authority and status by their peers or the public in a specific well-distinguished domain. Pilot Study : A pilot study is a small-scale experiment or set of observations undertaken to decide how and whether to launch a full-scale project.
Experimental Study : An experimental study is a type of evaluation that seeks to determine whether a program or intervention had the intended causal effect on program participants. Practice-based example : A practice-based example is an original investigation undertaken in order to gain new knowledge partly by means of practice and the outcomes of that practice.
Peer-Reviewed : A publication that contains original articles that have been written by scientists and evaluated for technical and scientific quality and correctness by other experts in the same field. Handbook for grading the quality of evidence and the strength of recommendations using the GRADE approach. Updated October Framing the health care question. Selecting and rating the importance of outcomes. Summarizing the evidence. Quality of evidence. Factors that can increase the quality of the evidence.
Dose-response gradient. Effect of plausible residual confounding. Going from evidence to recommendations. Questions about diagnostic tests. Establishing the purpose of a test. Establishing the role of a test. Clear clinical questions. Gold standard and reference test. Estimating impact on patients. Indirect evidence and impact on patient-important outcomes. Judgment about the quality of the underlying evidence. Initial study design.
Factors that determine and can decrease the quality of evidence. Risk of bias. Indirectness of the evidence. Inconsistency, imprecision, publication bias and upgrading for dose effect, large estimates of accuracy and residual plausible confounding. Overall confidence in estimates of effects. Glossary of terms and concepts. Additional resources. The Working Group is a collaboration of health care methodologists, guideline developers, clinicians, health services researchers, health economists, public health officers and other interested members.
Beginning in the year , the working group developed, evaluated and implemented a common, transparent and sensible approach to grading the quality of evidence and strength of recommendations in health care. The group interacts through meetings by producing methodological guidance, developing evidence syntheses and guidelines.
Membership is open and free. See www. The handbook is intended to be used as a guide by those responsible for using the GRADE approach to produce GRADE's output, which includes evidence summaries and graded recommendations.
Target users of the handbook are systematic review and health technology assessment HTA authors, guideline panelists and methodologists who provide support for guideline panels. While many of the examples offered in the handbook are clinical examples, we also aimed to include a broader range of examples from public health and health policy.
Finally, specific sections refer to interpreting recommendations for users of recommendations. Chapters Framing the health care question and Selecting and rating the importance of outcomes provide guidance on formulating health care questions for guidelines and systematic reviews and for rating the importance of outcomes in guidelines. Therefore, we interpret and will use the phrases quality of evidence, strength of evidence, certainty in evidence or confidence in estimates interchangeably.
When GRADE refers to confidence in the estimates it refers to the how certain one can be that the effect estimates are adequate to support a recommendation in the context of guideline development or that the effect estimate is close to that of the true effect in the context of evidence synthesis. Chapter Quality of evidence provides instructions for rating the evidence and addresses the five factors outlined in the GRADE approach that may result in rating down the quality of evidence and the three factors that may increase the quality of evidence.
Chapter Going from evidence to recommendations deals with moving from evidence to recommendations in guidelines and whether to classify recommendations as strong or weak according to the criteria outlined in the GRADE evidence to recommendation frameworks.
Throughout the handbook certain terms and concepts are hyperlinked to access definitions and the specific sections elaborating on those concepts.
The glossary of terms and concepts is provided in the Chapter Glossary of terms and concepts. Where applicable, the handbook highlights guidance that is specific to guideline developers or to systematic review authors as well as important notes pertaining to specific topics.
HTA practitioners, depending on their mandate, can decide which approach is more suitable for their goals. Furthermore, examples demonstrating the application of the concepts are provided for each topic. The examples are cited if readers wish to learn more about them from the source documents. The handbook is updated to reflect advances in the GRADE approach and based on feedback from handbook users.
We encourage users of the handbook to provide feedback and corrections to the handbook editors via email. Please refer to www. Permission to reproduce or translate the GRADE handbook for grading the quality of evidence and the strength of recommendation should be sought from the editors.
We would particularly like to acknowledge the contributions of Roman Jaeschke, Robin Harbour and Elie Akl to earlier versions of the handbook. The following authors have made major contributions to the current version of the handbook: Elie Akl, Reem Mustafa, Nancy Santesso Wojtek Wiercioch, and. The GRADE approach is a system for rating the quality of a body of evidence in systematic reviews and other evidence syntheses, such as health technology assessments, and guidelines and grading recommendations in health care.
GRADE offers a transparent and structured process for developing and presenting evidence summaries and for carrying out the steps involved in developing recommendations. It can be used to develop clinical practice guidelines CPG and other health care recommendations e. Steps and processes are interrelated and not necessarily sequential.
The guideline panel and supporting groups e. They typically report to an oversight committee or board overseeing the process. For example, while deciding how to involve stakeholders early for priority setting and topic selection, the guideline group must also consider how developing formal relationships with the stakeholders will enable effective dissemination and implementation to support uptake of the guideline.
Furthermore, considerations for organization, planning and training encompass the entire guideline development project, and steps such as documenting the methodology used and decisions made, as well as considering conflict-of-interest occur throughout the entire process. The system is designed for reviews and guidelines that examine alternative management strategies or interventions, which may include no intervention or current best management as well as multiple comparisons.
GRADE has considered a wide range of clinical questions, including diagnosis, screening, prevention, and therapy. GRADE provides a framework for specifying health care questions, choosing outcomes of interest and rating their importance, evaluating the available evidence, and bringing together the evidence with considerations of values and preferences of patients and society to arrive at recommendations.
Furthermore, the system provides clinicians and patients with a guide to using those recommendations in clinical practice and policy makers with a guide to their use in health policy. Application of the GRADE approach begins by defining the health care question in terms of the population of interest, the alternative management strategies intervention and comparator , and all patient-important outcomes.
As a specific step for guideline developers, the outcomes are rated according to their importance, as either critical or important but not critical. A systematic search is preformed to identify all relevant studies and data from the individual included studies is used to generate an estimate of the effect for each patient-important outcome as well as a measure of the uncertainty associated with that estimate typically a confidence interval.
The quality of evidence for each outcome across all the studies i. Authors of systematic reviews complete the process up to this step, while guideline developers continue with the subsequent steps. Health care related related tests and strategies are considered interventions or comparators as utilizing a test inevitably has consequences that can be considered outcomes see Chapter The GRADE approach for diagnostic tests and strategies. Next, guideline developers review all the information from the systematic search and, if needed, reassess and make a final decision about which outcomes are critical and which are important given the recommendations that they aim to formulate.
The overall quality of evidence across all outcomes is assigned based on this assessment. Guideline developers then formulate the recommendation s and consider the direction for or against and grade the strength strong or weak of the recommendation s based on the criteria outlined in the GRADE approach. The upper half describe steps in the process common to systematic reviews and making health care recommendations and the lower half describe steps that are specific to making recommendations based on GRADE meeting, Edingburgh Systematic reviews should provide a comprehensive summary of the evidence but they should typically not include health care recommendations.
Therefore, use of the GRADE approach by systematic review authors terminates after rating the quality of evidence for outcomes and clearly presenting the results in an evidence table, i.
Those developing health care recommendations, e. The following chapters will provide detailed guidance about the factors that influence the quality of evidence and strength of recommendations as well as instructions and examples for each step in the application of the GRADE approach. A detailed description of the GRADE approach for authors of systematic reviews and those making recommendations in health care is also available in a series of articles published in the Journal of Clinical Epidemiology.
An additional overview of the GRADE approach as well as quality of evidence and strength of recommendations in guidelines is available in a previously published six-part series in the British Medical Journal.
Briefer overviews have appeared in other journals, primarily with examples for relevant specialties. The articles are listed in Chapter Clinical practice guidelines offer recommendations for the management of typical patients. These management decisions involve balancing the desirable and undesirable consequences of a given course of action.
In order to help clinicians make evidence-based medical decisions, guideline developers often grade the strength of their recommendations and rate the quality of the evidence informing those recommendations. Prior grading systems had many disadvantages including the lack of separation between the quality of evidence and strength of recommendation, the lack of transparency about judgments, and the lack of explicit acknowledgment of values and preferences underlying the recommendations.
In addition, the existence of many, often scientifically outdated, grading systems has created confusion among guideline developers and end users. Although the GRADE approach makes judgments about quality of evidence, that is confidence in the effect estimates, and strength of recommendations in a systematic and transparent manner, it does not eliminate the need for judgments. Thus, applying the GRADE approach does not minimize the importance of judgment or as suggesting that quality can always be objectively determined.
Although evidence suggests that these judgments, after appropriate methodological training, lead to reliable assessment of the quality of evidence Mustafa R et al. There will be cases in which those making judgments will have legitimate disagreement about the interpretation of evidence. GRADE provides a framework guiding through the critical components of the assessment in a structured way.
By allowing to make the judgments explicit rather than implicit it ensures transparency and a clear basis for discussion. A number of criteria should be used when moving from evidence to recommendations see Chapter on Going from evidence to recommendations. During that process, separate judgements are required for each of these criteria. In particular, separating judgements about the confidence in estimates or quality of evidence from judgements about the strength of recommendations is important as high confidence in effect estimates does not necessarily imply strong recommendations, and strong recommendations can result from low or even very low confidence in effect estimates insert link to paradigmatic situations for when strong recommendations are justified in the context of low or very low confidence in effect estimates.
Grading systems that fail to separate these judgements create confusion, while it is the defining feature of GRADE. The GRADE approach stresses the necessity to consider the balance between desirable and undesirable consequences and acknowledge other factors, for example the values and preferences underlying the recommendations.
As patients with varying values and preferences for outcomes and interventions will make different choices, guideline panels facing important variability in patient values and preferences are likely to offer a weak recommendation despite high quality evidence.
Considering importance of outcomes and interventions, values, preferences and utilities includes integrating in the process of developing a recommendation, how those affected by its recommendations assess the possible consequences. These include patient and carer knowledge, attitudes, expectations, moral and ethical values, and beliefs; patient goals for life and health; prior experience with the intervention and the condition; symptom experience for example breathlessness, pain, dyspnoea, weight loss ; preferences for and importance of desirable and undesirable health outcomes; perceived impact of the condition or interventions on quality of life, well-being or satisfaction and interactions between the work of implementing the intervention, the intervention itself, and other contexts the patient may be experiencing; preferences for alternative courses of action; and preferences relating to communication content and styles, information and involvement in decision-making and care.
This can be related to what in the economic literature is considered utilities. An intervention itself can be considered a consequence of a recommendation e. Both the direction and the strength of a recommendation may be modified after taking into account the implications for resource utilization, equity, acceptability and feasibility of alternative management strategies.
Therefore, unlike many other grading systems, the GRADE approach emphasizes that weak also known as conditional recommendations in the face of high confidence in effect estimates of an intervention are common because of these factors other than the quality of evidence influencing the strength of a recommendation.
For the same reason it allows for strong recommendations on the basis of low or very confidence in effect estimates. Example 1: Weak recommendation based on high quality evidence. Several RCTs compared the use of combination chemotherapy and radiotherapy versus radiotherapy alone in unresectable, locally advanced non-small cell lung cancer Stage IIIA. The overall quality of evidence for the body of evidence was rated high.
Compared with radiotherapy alone, the combination of chemotherapy and radiotherapy reduces the risk of death corresponding to a mean gain in life expectancy of a few months, but increases harm and burden related to chemotherapy. Example 2: Weak recommendation based on high quality evidence.
Patients who experience a first deep venous thrombosis with no obvious provoking factor must, after the first months of anticoagulation, decide whether to continue taking the anticoagulant warfarin long term. High quality randomized controlled trials show that continuing warfarin will decrease the risk of recurrent thrombosis but at the cost of increased risk of bleeding and inconvenience.
Because patients with varying values and preferences will make different choices, guideline panels addressing whether patients should continue or terminate warfarin should, despite the high quality evidence, offer a weak recommendation. Example 3: Strong recommendation based on low or very low quality evidence. The principle of administering appropriate antibiotics rapidly in the setting of severe infection or sepsis has not been tested against its alternative of no rush of delivering antibiotics in randomized controlled trials.
Those applying GRADE to questions about diagnostic tests, public health or health systems will face some special challenges. This handbook will address these challenges and undergo revisions when new developments prompt the GRADE working group to agree on changes to the approach.
Moreover, there will be methodological advances and refinements in the future not only of innovations but also of the established concepts. GRADE recommends against making modifications to the approach because the elements of the GRADE process are interlinked, because modifications may confuse some users of evidence summaries and guidelines, and because such changes compromise the goal of a single system with which clinicians, policy makers, and patients can become familiar.
However, the literature on different approaches to applying GRADE is growing and are useful to determine when pragmatism is appropriate. A guideline panel should define the scope of the guideline and the planned recommendations. Each recommendation should answer a focused and sensible health care question that leads to an action. Similarly, authors of systematic reviews should formulate focused health care question s that the review will answer.
A systematic review may answer one or more health care questions, depending on the scope of the review. The PICO framework presents a well accepted methodology for framing health care questions. It mandates carefully specifying four components:. A number of derivatives of this approach exist, for example adding a T for time or S for study design. These modifications are neither helpful nor necessary. The issue of time e.
In addition, the studies, and therefore the study design, that inform an answer are often not known when the question is asked. That is, observational studies may inform a question when randomized trials are no available or not associated with high confidence in the estimates. Thus, it is usually not sensible to define a study design beforehand. A guideline question often involves another specification: the setting in which the guideline will be implemented.
For instance, guidelines intended for resource-rich environments will often be inapplicable to resource-poor environments. Even the setting, however, can be defined as part of the definition of the population e.
Errors that are frequently made in formulating the health care question include failure to include all patient-important outcomes e. The most challenging decision in framing the question is how broadly the patients and intervention should be defined see Example 1.
For the patients and interventions defined, the underlying biology should suggest that across the range of patients and interventions it is plausible that the magnitude of effect on the key outcomes is more or less the same.
If that is not the case the review or guideline will generate misleading estimates for at least some subpopulations of patients and interventions. For instance, based on the information presented in Example 1, if antiplatelet agents differ in effectiveness in those with peripheral vascular disease vs. These subpopulations should, therefore, be defined separately.
Often, systematic reviews deal with the question of what breadth of population or intervention to choose by starting with a broad question but including a priori specification of subgroup effects that may explain any heterogeneity they find.
The a priori hypotheses may relate to differences in patients, interventions, the choice of comparator, the outcome s , or factors related to bias e.
Example 1: Deciding how to broadly to define the patients and intervention. Addressing the effects of antiplatelet agents on vascular disease, one might include only patients with transient ischemic attacks, those with ischemic attacks and strokes, or those with any vascular disease cerebro-, cardio-, or peripheral vascular disease.
The intervention might be a relatively narrow range of doses of aspirin, all doses of aspirin, or all antiplatelet agents. Because the relative risk associated with an intervention vs. Recommendations, however, may differ across subgroups of patients at different baseline risk of an outcome, despite there being a single relative risk that applies to all of them. For instance, the case for warfarin therapy, associated with both inconvenience and a higher risk of serious bleeding, is much stronger in atrial fibrillation patients at substantial vs.
Thus, guideline panels must often define separate questions and produce separate evidence summaries for high- and low-risk patients, and patients in whom quality of evidence differs. Another important challenge arises when there are multiple comparators to an intervention. Clarity in choice of the comparator makes for interpretable guidelines, and lack of clarity can cause confusion. Sometimes, the comparator is obvious, but when it is not guideline panels should specify the comparator explicitly.
In particular, when multiple agents are involved, they should specify whether the recommendation is suggesting that all agents are equally recommended or that some agents are recommended over others see Example 1. When making recommendations for use of anticoagulants in patients with non-ST elevation acute coronary syndromes receiving conservative non-invasive management, fondaparinux, heparin, and enoxaparin may be the agents being considered.
Moreover, the estimate of effect for each agent may come from evidence of varying quality e. Therefore, it must be made clear whether the recommendations formulated by the guideline panel will be for use of these agents vs. GRADE has begun to tackle the question of determining the confidence in estimates for prognosis.
They are often important for guideline development. For example, addressing interventions that may influence the outcome of influenza or multiple sclerosis will require establishing the natural history of the conditions.
This will involve specifying the population influenza or new-onset multiple sclerosis and the outcome mortality or relapse rate and progression. Such questions of prognosis may be refined to include multiple predictors, such as age, gender, or severity. The answers to these questions will be an important background for formulating recommendations and interpreting the evidence about the effects of treatments. In particular, guideline developers need to decide whether the prognosis of patients in the community is similar to those studied in the trials and whether there are important prognostic subgroups that they should consider in making recommendations.
Judgments if the evidence is direct enough in terms of baseline risk affect the rating about indirectness of evidence. Defining a health care question includes specifying all outcomes of interest.
Those developing recommendations whether or not to use a given intervention therapeutic or diagnostic have to consider all relevant outcomes simultaneously. The Guideline Development Tool allows the selection of two different formats for questions about management:.
Should manual toothbrushes vs. Should topical nasal steroids be used in children with persistent allergic rhinitis? Should oseltamivir versus no antiviral treatment be used to treat influenza? Should troponin I followed by appropriate management strategies or troponin T followed by appropriate management strategies be used to manage acute myocardial infarction? Given that recommendations cannot be made on the basis of information about single outcomes and decision-making always involves a balance between health benefits and harms.
Authors of systematic reviews will make their reviews more useful by looking at a comprehensive range of outcomes that allow decision making in health care. Many, if not most, systematic reviews fail to address some key outcomes, particularly harms, associated with an intervention. On the contrary, to make sensible recommendations guideline panels must consider all outcomes that are important or critical to patients for decision making.
In addition, they may require consideration of outcomes that are important to others, including the use of resources paid for by third parties, equity considerations, impacts on those who care for patients, and public health impacts e. Guideline developers must base the choice of outcomes on what is important, not on what outcomes are measured and for which evidence is available. If evidence is lacking for an important outcome, this should be acknowledged, rather than ignoring the outcome.
Because most systematic reviews do not summarize the evidence for all important outcomes, guideline panels must often either use multiple systematic reviews from different sources, conduct their own systematic reviews or update existing reviews. Guideline developers must, and authors of systematic reviews are strongly encouraged to specify all potential patient-important outcomes as the first step in their endeavour. Guideline developers will also make a preliminary classification of the importance of the outcomes.
GRADE specifies three categories of outcomes according to their importance for decision-making :. Critical and important outcomes will bear on guideline recommendations, the third will in most situations not.
Ranking outcomes by their relative importance can help to focus attention on those outcomes that are considered most important, and help to resolve or clarify disagreements. Table 3. Guideline developers should first consider whether particular health benefits and harms of a therapy are important to the decision regarding the optimal management strategy, or whether they are of limited importance. If the guideline panel thinks that a particular outcome is important, then it should consider whether the outcome is critical to the decision, or only important, but not critical.
To facilitate ranking of outcomes according to their importance guideline developers may choose to rate outcomes numerically on a 1 to 9 scale 7 to 9 — critical; 4 to 6 — important; 1 to 3 — of limited importance to distinguish between importance categories.
Practically, to generate a list of relevant outcomes, one can use the following type of scales. The first step of a classification of importance of outcomes should occur during protocol of a systematic review or when the panel agrees on the health care questions that should be addressed in a guideline. Thus, it should be done before a protocol is developed. When evidence becomes available a reassessment of importance may be necessary to ensure that important outcomes identified by reviews of the evidence that were not initially considered are included and to reconsider the relative importance of outcomes in light of the available evidence which will be influenced by the relative importance of the outcome.
It is possible that there is no association between the outcome and the intervention of interest which supports to not consider that outcome further.
Guideline panels should be aware of the possibility that in some instances the importance of an outcome e. Example 1: Hierarchy of outcomes according to their importance to assess the effect of oseltamivir in patients with H5N1 influenza.
Patient are usually affected by severe respiratory compromise and require ventilatory support. Complications of a potentially useful medication, oseltamivir, are suspected to be of temporary neurological nature, other adverse effects such as nausea also occur during treatment. Example 2. Hierarchy of outcomes according to their importance to assess the effect of phosphate-lowering drugs in patients with renal failure and hyperphosphatemia.
Example 3: Reassessment of the relative importance of outcomes. Consider, for instance, a screening intervention, such as screening for aortic abdominal aneurysm.
Let us say, however, that the evidence summary establishes an important reduction in cause-specific mortality from abdominal aortic aneurysm but fails to definitively establish a reduction in all-cause mortality.
The reduction in cause-specific mortality may be judged sufficiently compelling that, even in the absence of a demonstrated reduction in all-cause mortality which may be undetected because of random error from other causes of death , the screening intervention is clearly worthwhile.
All-cause mortality then becomes less relevant and ceases to be a critical outcome. The relative importance of outcomes should be considered when determining the overall quality of evidence, which may depend on which outcomes are ranked as critical or important see Chapter Quality of evidence , and judging the balance between the health benefits and harms of an intervention when formulating the recommendations see Chapter Going from evidence to recommendations.
Only outcomes considered critical rated are the primary factors influencing a recommendation and will be used to determine the overall quality of evidence supporting a recommendation. Preliminary classification of outcomes as critical, important but not critical, or low importance, before reviewing the evidence.
To focus attention on those outcomes that are considered most important when searching for and summarizing the evidence and to resolve or clarify disagreements. Conducting a systematic review of the relevant literature.
By asking panel members and possibly patients or members of the public to identify important outcomes, judging the relative importance of the outcomes and discussing disagreements.
These judgments are ideally informed by a systematic review of the literature focusing on what the target population considers as critical or important outcomes for decision making.
Literature about values, preferences or utilities is often used in these reviews, that should be systematic in nature. Alternatively the collective experience of the panel members, patients, and members of the public can be used using transparent methods for documenting and considering them see Santesso N et al, IJOBGYN Prior knowledge of the research evidence or, ideally, a systematic review of that evidence is likely to be helpful.
Reassessment of the relative importance of outcomes after reviewing the evidence. To ensure that important outcomes identified by reviews of the evidence that were not initially considered are included and to reconsider the relative importance of outcomes in light of the available evidence. By asking the panel members and, if relevant, patients and members of the public to reconsider the relative importance of the outcomes included in the first step and any additional outcomes identified by reviews of the evidence.
Experience of the panel members and other informants and systematic reviews of the effects of the intervention. Judging the balance between the desirable and undesirable health outcomes of an intervention.
To support making a recommendation and to determine the strength of the recommendation. By asking the panel members to balance the desirable and undesirable health outcomes using an evidence to recommendation framework that includes a summary of findings table or evidence profile and, if relevant, based on a decision analysis.
Experience of the panel members and other informants, systematic reviews of the effects of the intervention, evidence of the value that the target population attach to key outcomes if relevant and available and decision analysis or economic analyses if relevant and available. The importance of outcomes is likely to vary within and across cultures or when considered from the perspective of the target population e. Cultural diversity will often influence the relative importance of outcomes, particularly when developing recommendations for an international audience.
Guideline panels must decide what perspective they are taking. Although different panels may elect to take different perspectives e. When the target audiences for a guideline are clinicians and the patients they treat, the perspective would generally be that of the patient. In the absence of such evidence , panel members should use their prior experiences with the target population to assume the relevant values and preferences.
Not infrequently, outcomes of most importance to patients remain unexplored. When important outcomes are relatively infrequent, or occur over long periods of time, investigators often choose to measure substitutes, or surrogates, for those outcomes. Guideline developers should consider surrogate outcomes only when evidence about population-important outcomes is lacking. When this is the case, they should specify the population-important outcomes and, if necessary, the surrogates they are using to substitute for those important outcomes.
Guideline developers should not list the surrogates themselves as their measures of outcome. The necessity to substitute the surrogate may ultimately lead to rating down the quality of the evidence because of the indirectness see Chapter Quality of evidence.
Outcomes selected by the guideline panel should be included in an evidence profile whether or not information about them is available see Chapter Summarizing the evidence , that is an empty row in an evidence profile can be informative in that it identifies research gaps. A guideline panel should base its recommendation on the best available body of evidence related to the health care question.
A guideline panel can use already existing high quality systematic reviews or conduct its own systematic review depending on the specific circumstances such as availability of high quality systematic reviews and resources, but GRADE recommends that systematic reviews should form the basis for making health care recommendations.
One should seek evidence relating to all patient-important outcomes and for the values patients place on these outcomes as well as related management options. The endpoint for systematic reviews and for HTA restricted to evidence reports is a summary of the evidence, the quality rating for each outcome and the estimate of effect. For guideline developers and HTA that provide advice to policymakers, a summary of the evidence represents a key milestone on the path to a recommendation.
The evidence collected from systematic reviews is used to produce GRADE evidence profile and summary of findings table. An evidence table is a key tool in the presentation of evidence and the corresponding results. Evidence tables are a method for presenting the quality of the available evidence, the judgments that bear on the quality rating, and the effects of alternative management strategies on the outcomes of interest.
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