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Grade Resource Use 2008 05 14

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  • 1. Resource use San Sebastián 14 May 2008 Pablo Alonso, Victor Montori, Andy Oxman, Holger Schünemann
  • 2. A balance sheet is a simple but powerful way to present the advantages and disadvantages of the management options under consideration
  • 3. What about the costs of compression stockings?
    • All the stockings in the 9 trials included in this review were below-knee compression stockings.  In four trials the compression strength was 20-30 mm Hg at the ankle. It was 10-20 mm Hg in the other four trials. Stockings come in different sizes. If a stocking is too tight around the knee it can prevent essential venous return causing the blood to pool around the knee. Compression stockings should be fitted properly. A stocking that is too tight could cut into the skin on a long flight and potentially cause ulceration and increased risk of DVT. Some stockings can be slightly thicker than normal leg covering and can be potentially restrictive with tight foot wear. It is a good idea to wear stockings around the house prior to travel to ensure a good, comfortable fitting. Stockings were put on 2 to 3 hours before the flight in most of the trials. The availability and cost of stockings can vary.
  • 4. What about the costs of compression stockings?
    • All the stockings in the 9 trials included in this review were below-knee compression stockings.  In four trials the compression strength was 20-30 mm Hg at the ankle. It was 10-20 mm Hg in the other four trials. Stockings come in different sizes. If a stocking is too tight around the knee it can prevent essential venous return causing the blood to pool around the knee. Compression stockings should be fitted properly. A stocking that is too tight could cut into the skin on a long flight and potentially cause ulceration and increased risk of DVT. Some stockings can be slightly thicker than normal leg covering and can be potentially restrictive with tight foot wear. It is a good idea to wear stockings around the house prior to travel to ensure a good, comfortable fitting. Stockings were put on 2 to 3 hours before the flight in most of the trials. The availability and cost of stockings can vary.
  • 5. What about the costs of compression stockings?
    • All the stockings in the 9 trials included in this review were below-knee compression stockings.  In four trials the compression strength was 20-30 mm Hg at the ankle. It was 10-20 mm Hg in the other four trials. Stockings come in different sizes. If a stocking is too tight around the knee it can prevent essential venous return causing the blood to pool around the knee. Compression stockings should be fitted properly. A stocking that is too tight could cut into the skin on a long flight and potentially cause ulceration and increased risk of DVT. Some stockings can be slightly thicker than normal leg covering and can be potentially restrictive with tight foot wear. It is a good idea to wear stockings around the house prior to travel to ensure a good, comfortable fitting. Stockings were put on 2 to 3 hours before the flight in most of the trials. The availability and cost of stockings can vary.
  • 6. B alance sheets should inform judgments about whether the net benefits are worth the incremental costs
  • 7. Economic models versus balance sheets
    • Given the complexity of economic models and limited resources for constructing these, it is not feasible to undertake full economic models for all recommendations.
    • Moreover, even when economic models are used, a balance sheet is still useful for ensuring decision-makers’ understanding and appraisal of the key estimates used in an economic model.
    • They can also help decision makers to focus on the quality of the evidence used in an economic model.
  • 8. Important economic consequences should be included in SoF tables along with other important outcomes (whether or not an economic model is used)
    • 4 steps
    • Identify resource consequences
      • Guideline developers must identify resource consequences that are potentially important to decision makers.
    • Find evidence
      • They must then find evidence of the differences in resource use for the options being compared.
    • Appraise the evidence
      • They then need to appraise the quality of that evidence.
    • Value the resources
      • They may then need to value the resources used in monetary terms for the specific setting for which recommendations are being made.
  • 9. The perspective should be explicit
    • The audience may be narrow
      • a single hospital pharmacy
      • an individual hospital
      • a health maintenance organization
    • Alternatively it could be broad
      • a health region
      • a country
      • an international audience
  • 10. A broad perspective is desirable
    • In a publicly funded health system the patient perspective would ignore most of the costs generated
    • A pharmacy perspective would ignore down-stream cost savings resulting for adverse events (e.g. stroke or myocardial infarction) prevented by a drug
    • A hospital perspective would ignore out-patient costs either incurred, or prevented.
    • In the private sector, where disenrollment and loss of insurance can shift the burden of costs from one system to another, estimates of resource use should include the down-stream costs of all treated patients, not just those who remain in a particular health plan.
  • 11. Advantages of a broad perspective
    • A comprehensive display of the resource use associated with alternative management strategies allows an individual or group – a patient, a hospital or a pharmacy – to examine the relative merits of the alternatives from their particular perspective.
    • Indirect costs or savings (e.g. lost wages).
      • difficult to estimate
      • controversial because they assume that lost productivity will not be replaced by an individual who otherwise would be unemployed or underemployed, and implicitly place lower value on individuals not working (e.g. the retired)
  • 12. Identifying resource consequences
    • 1) Consider whether overall resource use (costs) is important relative to health outcomes.
    • 2) If it is, consider specific types of resources and consider their relative importance; i.e. which should be included in a summary of findings table and which are critical to a decision.
  • 13. Potentially important resource consequences
  • 14. Identifying resource consequences
    • Included resource consequences should be classified as critical or important
    • It may be appropriate to aggregate different types of resource use
      • Sometimes necessary due to inadequate reporting
    • Consider whether resource consequences are potentially important prior to summarizing the available evidence
      • Reconsider those judgments after the available evidence is summarized
  • 15. Finding economic evidence
    • Systematic reviews
    • Randomized trials
      • In or separate from clinical studies
    • Observational studies
    • National or local databases
      • drug use from prescription databases
      • hospitalizations from hospital databases
  • 16. Finding economic evidence
  • 17. Finding economic evidence
    • Often guideline developers will not find sufficient evidence for resource consequences that they consider important
    • For example, WHO guideline on the prevention of postpartum haemorrhage
      • Should oral misoprostol be used for all women by skilled providers to prevent postpartum haemorrhage instead of IM oxytocin?
      • Hospitalization, personnel and drugs were considered important resources
      • No evidence was found for hospitalization or personnel
  • 18. If possible, resource use should be presented in natural units
    • When only total costs are reported, resource use cannot be separated from unit costs
    • Without information about resource use it is difficult to make judgments about the applicability of the evidence to different settings
    • Unit prices can be misleading, for example if mean costs are used rather than marginal costs (ref), can be difficult to estimate, and may vary across settings
    • When global recommendations are made different context specific patterns of resource use can be considered, if relevant
  • 19. Attaching monetary values to resource use
    • When a recommendation is made in a specific context, attaching appropriate monetary values to resource use can have several advantages.
    • Monetary values may be easily understood by decision makers
    • Attaching monetary values makes it possible to aggregate different types of resource use
    • The use of appropriate monetary values can help to ensure that resource use is valued consistently and appropriately by decision makers
  • 20. Attaching monetary values to resource use
    • Use data specific to the context of a recommendation, providing transparent unit costs
    • Costs should, if possible, take account of severity
      • For example, to estimate costs for MI of various degrees of severity
      • Appropriate for nursing and physician time based on severity
      • Time spent providing care multiplied by an hourly wage to arrive at the cost of labor time
    • For resources from different health contexts and timeframes, purchasing power parity (PPP) exchange rates and inflation factors should be used
    • Probably best NOT to discount in SoF tables
  • 21. Appraising the quality of evidence for resource use
    • There are more than 20 checklists and instruments for assessing the quality of economic analyses in the healthcare literature
    • These instruments are mainly related to the development and reporting of economic models.
    • They are not constructed to assess the quality of evidence as defined by GRADE
  • 22. Appraising the quality of evidence for resource use
    • The quality of evidence should be appraised explicitly for each important resource consequence using the same criteria as for health outcomes
    • As with health outcomes, in determining the overall quality of evidence across outcomes only critical resources consequences should be taken into account
  • 23. Study limitations (risk of bias)
    • There may be additional risks of bias for resource consequences related to
    • The measurement of resource use
      • Use of unreliable cost data
      • Use of cost data from non-comparable settings should be avoided
    • Follow-up
    • Sampling of patients to collect resource data
    • Validation of self-reported data
  • 24. Inconsistency
    • Judgements about the consistency of estimates of differences in resource use are difficult due to
      • Poor reporting
      • Variation can be expected if there are different patterns of resource use in the settings where studies were done
    • Generally, directness of the evidence (from the same or a similar setting) is more likely to be important for resource consequences than for health outcomes
    • As a consequence of wide variation in patterns of resource use, guideline developers will frequently choose to focus on the evidence that is most direct, rather than on an average across different settings
    • When data are available from more than one study from a similar setting, judgements about the consistency of estimates should be based on resource use rather than on costs
  • 25. Indirectness
    • Another type of indirectness that is common for evidence of resource use is the length of follow-up, since decision makers are often interested in resource use beyond the length of follow-up for clinical studies
      • In particular for chronic diseases
    • Indirectness of evidence of resource use may also result from differences in providers
      • For example, teaching and research-based hospitals have higher costs relative to nonteaching hospitals
    • Evidence from older studies may be indirect due to changes in the use of technologies
      • For example, decreasing prices for generic drugs could change prescribing patterns
  • 26. Imprecision
    • Large variability in healthcare resource
      • Larger sample sizes may be required for resource use data than for health outcomes
    • Clinical trials are often underpowered to detect differences in resource use
    • Moreover, a number of studies do not report confidence intervals or p-values for economic estimates
  • 27. Publication bias
    • Evidence of publication bias for economic analyses as well as for clinical studies
    • For example, studies of depression were more likely to report an economic evaluation if they had larger clinical effects
  • 28. Using economic models to inform recommendations
    • Economic models have advantages over balance sheets
      • Particularly allowing for more explicit and complex sensitivity analyses
    • Economic models should be considered when
      • Decisions are complex and involve multiple important outcomes and resource consequences over long periods of time or
      • Large capital investments, such as building new facilities or purchasing new, expensive equipment
  • 29. Using economic models to inform recommendations
    • Evidence profiles should be constructed to inform recommendations whether or not an economic model is used
    • The results of economic models should not be incorporated in evidence profiles because
      • They represent an attempt to analyse health and resource information already summarised in the evidence profile and
      • They are a mixture of evidence of varying quality and assumptions
  • 30. The quality of the evidence used in economic models is rarely explicitly assessed
    • Sensitivity analyses are used to test assumptions, but rarely directly take into account the quality of the evidence
    • Tables that present the data used to build an economic model rarely include assessments of the quality of evidence for each estimate that is used
  • 31. Cost per quality-adjusted life year (QALY) thresholds
    • Cost per QALY allows for comparisons across different interventions and conditions
    • However, it is uncertain how helpful these estimates are to decision makers or how they are used
    • On the other hand, balance sheets are generally not helpful for comparisons across different interventions in a health system
    • Thus, if costs per QALY are used, they should be used cautiously, and decision makers should be presented with evidence profiles together with the results of economic models
  • 32. Presenting the results of economic models together with SoF tables
  • 33. When should resource use be presented?
    • A panel may legitimately choose to leave considerations of resource use aside, and offer a recommendation solely on the basis of other advantages and disadvantages of the alternatives being considered.
    • Resource allocation must then be considered at the level of the ultimate decision-maker
  • 34. When should resource use be presented?
    • If a panel considers resource use it should, prior to bringing cost into the equation, first decide on the quality of evidence regarding other outcomes, and weigh up the advantages and disadvantages.
    • Resource implications may be irrelevant if
      • evidence of net health benefits is lacking
      • advantages of an intervention far outweigh disadvantages
    • Resource use usually becomes important when advantages and disadvantages are closely balanced.
  • 35.  
  • 36.  
  • 37.  
  • 38.  
  • 39. Even when – as in this case – cost/effect estimates are credible, they do not provide clear answers regarding appropriate action
    • Most people would consider the cost per episode of eclampsia prevented for severe pre-eclampsia well worth it.
    • For pre-eclampsia that is not severe, and particularly for low-income countries, the decision may be more difficult.
    • Ultimately, decision-makers would need to weigh the relative value of preventing pre-eclampsia against the benefits the health system, or society, would forego in allocating resources to magnesium sulphate administration.
  • 40. Strength of recommendation
    • The degree of confidence that the desirable effects of adherence to a recommendation outweigh the undesirable effects.
    • Desirable effects
    • health benefits
    • less burden
    • savings
    • Undesirable effects
    • harms
    • more burden
    • costs
  • 41. Priority setting: From a health system or public health perspective A strong recommendation may not be important
  • 42. Possible criteria for making a recommendation or a decision
    • Treatment effect (benefit)
    • Adverse effects
    • Cost (affordability)
    • Cost-effectiveness
    • Equity
    • Seriousness of the problem
    • Administrative restrictions
  • 43. From the perspective of individual patients and clinicians
    • Most patients would want and should receive strongly recommended courses of action
    • The majority of people would want weakly recommended courses of action, but many would not and clinicians should be prepared to help patients make a decision that is consistent with their own values
    • The issue of priority setting (importance) is usually not important.
  • 44.  
  • 45. Should patients with partial epilepsy be treated with lamotrigine instead to carbamazepine?
  • 46.  
  • 47.  
  • 48.