| Literature DB >> 20018106 |
Andrew D Oxman1, John N Lavis, Atle Fretheim, Simon Lewin.
Abstract
This article is part of a series written for people responsible for making decisions about health policies and programmes and for those who support these decision makers. In this article, we address the use of evidence to inform judgements about the balance between the pros and cons of policy and programme options. We suggest five questions that can be considered when making these judgements. These are: 1. What are the options that are being compared? 2. What are the most important potential outcomes of the options being compared? 3. What is the best estimate of the impact of the options being compared for each important outcome? 4. How confident can policymakers and others be in the estimated impacts? 5. Is a formal economic model likely to facilitate decision making?Entities:
Year: 2009 PMID: 20018106 PMCID: PMC2809501 DOI: 10.1186/1478-4505-7-S1-S16
Source DB: PubMed Journal: Health Res Policy Syst ISSN: 1478-4505
Figure 1Balancing the pros and cons of health policies and programmes. Decisions about health policy or programme options require judgements about whether the desirable consequences of an option are worth the undesirable consequences
The pros and cons of balance sheets
| A balance sheet is a simple but powerful way to present the advantages and disadvantages of different options, including policy options [ |
| The aim of a balance sheet is to help decision makers develop an accurate understanding of the important consequences of the options being compared. Balance sheets help to achieve this in a number of ways. Firstly, they condense the most important information, thus enabling efficient consideration. Secondly, balance sheets focus attention on the most important outcomes. This increases the likelihood that decision makers will gain an accurate perception of what is known about the impacts of the options being considered and the important consequences. Thirdly, the act of constructing a balance sheet is a helpful mechanism for organising thinking, structuring evidence analysis, and focusing debate. Fourthly, balance sheets can help to develop more explicit judgements about what the most important consequences of policy options are, the underlying evidence, and subsequent judgements about the balance between the relative advantages and disadvantages of the various options. Lastly, balance sheets can provide other decision makers with 'raw information', thereby helping them to apply their own judgements about the trade-offs between desirable and undesirable consequences. |
| But two important limitations also need to be considered when using balance sheets in decision making. Firstly, when there are complicated trade-offs between multiple outcomes, judgements may require a high level of information processing by policymakers. Secondly, when weighing up different outcomes, the value judgements employed by policymakers could remain implicit. Formal economic modelling may help to address these limitations by making any underlying assumptions (including value judgements) more explicit. This enables the use of sensitivity analyses to explore the effects of both uncertainties and varying assumptions on the results. |
Should the licensing of tobacco retailers be conditional on not selling tobacco to minors?
| 0 | ? | 1,650 in the country | 4 | Very low‡ | |
| 0 | ? | 9,240 in the country | 4 | Very low§ | |
| €10,5 million | ? | €2 million | 0 | Very low** | |
*The proposed licensing law in the European country in question would require retailers to have a licence to sell tobacco. The policy options that were considered included three compliance checks per year, and one per year together with internal control. Compliance checks (by a teenager attempting to purchase tobacco) are done to ensure that tobacco is not being sold to minors. The penalty for non-compliance is the loss of a retail licence. Internal control requires the retailers themselves to have routines for controlling the sale of tobacco to minors
†See Table 8
‡The systematic review used as a basis for this summary (which was not used in the expert report to which we refer in subsequent tables) included one relevant randomised trial and three controlled before-after studies with important limitations. There was a high risk of bias for the estimated impacts on smoking prevalence. Important inconsistencies in the results lacked a compelling explanation. The studies in the review were based in the United States (2), the United Kingdom (1) and Australia (1), with differences in the interventions and uncertainty about whether similar results would be expected in the country where this policy was being considered. Two studies found an effect in lower age groups that was not sustained in one study; two studies did not find a change in smoking behaviour. It is difficult to estimate, based on these studies, what the best estimate would be of the impact of licensing of tobacco retailers with compliance checks on reducing the number of people who smoke. A lower estimate would be that there would be no impact from this intervention. The upper estimate is taken from an expert report (see Tables 3 5)
§The upper estimate of life years saved, which is taken from the same expert report, has the same limitations as the estimate of the impact on smoking behaviour, since it is based on that estimate. In addition, it is based on assumptions about what would happen long beyond the length of the studies that had evaluated impacts on smoking behaviour as well, and assumptions about the impact of the changes in smoking behaviour on mortality
**The estimates of the cost of the policy are taken from the expert report (described in subsequent tables in this article). These are based on an estimate of how many retailers sold tobacco, an assumption about what it would cost to process each licence, and an assumption about the costs of each compliance check
What is being compared? Case example: The licensing of tobacco retailers
| The reduction of teenage smoking was a priority for a Minister of Health in a European country. A report of policy options to achieve this was commissioned by the government concerned and a report was prepared by leading public health experts. One of the policy options considered in the report was the licensing of tobacco retailers. The loss of such a license was proposed as a penalty for the illegal selling of tobacco to minors. This option was compared in the report to the status quo, namely the absence of licensing for tobacco retailers. The public health experts did not undertake or use a systematic review, nor did they specify which characteristics of the policy option (or comparator) they considered to be crucial or important. |
| A number of important issues were not considered in the report. Important differences, for example, might have existed between the status quo of the areas where the policymakers considered implementing the policy and those where the studies were done. Such considerations may have included other policies already in place to reduce the sales of tobacco to minors. It is possible that existing legislation may already have made the sale of tobacco to minors illegal, or contained other methods by which legislation could be enforced (e.g. through fines or other penalties for the illegal sale of tobacco, face-to-face education of retailers (informing them about the legal requirements), or media campaigns (to raise community awareness). There might also have been differences in the ease with which minors could obtain tobacco from other sources (e.g. from parents and friends or through theft). |
| The experts explicitly considered two policy options for the licensing of tobacco retailers, namely three compliance checks per year (by a teenager attempting to purchase tobacco) to make sure that retailers were not selling tobacco to minors, and one compliance check per year together with internal control (requiring retailers themselves to control that tobacco is not being sold to minors). The penalty for non-compliance in both cases was the loss of the relevant licence. Other ways of enforcing licensing are possible, some of which have been evaluated in other studies. The experts writing this report did not explicitly address whether differences in approaches to licensing enforcement were likely to result in important differences in the effectiveness of the policy. |
What are the most important outcomes? Case example: The licensing of tobacco retailers
| The primary outcome considered by the expert report commissioned by the government concerned was the prevalence of smoking. This was recognised to be a surrogate outcome for the consequences of smoking. The impact on life years saved was estimated based on the estimated impact on the prevalence of smoking and on epidemiological data linking smoking to mortality. Impacts on morbidity were not considered. Other impacts that were explicitly considered by the experts were administrative costs, political acceptability and public acceptability. There are a number of other outcomes that the expert report could have considered, including: |
| • Costs to retailers and potential harms (e.g. increased theft or cross-border shopping) |
| • Who would pay the administrative costs of such schemes |
| • The potential differences in the impacts of the policy on different populations (e.g. socio-economically disadvantaged minors or those living close to the country's border (who could potentially cross over into a neighbouring country to purchase tobacco) |
| • Ethical consequences (e.g. those related to the use of a minor or person pretending to be a minor for compliance checks, or the fairness of the policy in relation to the potentially different impacts on different groups of minors and different retailers) |
What are the best estimates of the impacts? Case example: The licensing of tobacco retailers
| The expert report on policies to reduce teenage smoking commissioned by the government concerned estimated that licensing tobacco retailers would result in a 10% relative reduction in the number of smokers. Using the current prevalence of smokers as a reference, the absolute effect of the policy was estimated to be a reduction of 1,650 smokers per year. Based on epidemiological models of the increased risk of dying due to smoking, the experts estimated that this policy would save 9,240 lives per year. No confidence intervals were provided, although it was noted that the actual effect was very uncertain and a range of estimates was used to calculate the cost-effectiveness of licensing tobacco retailers. Administrative costs were estimated, based on an estimate of how many retailers sold tobacco, an assumption about what it would cost to process each licence, and an assumption about what each inspection would cost (to check compliance with the requirement not to sell tobacco to minors). |
| Using these different assumptions, the total estimated cost was between €7.2 million and €10.5 million per year. |
Confidence intervals
| A confidence interval (CI) is the range around an estimate which conveys how precise the estimate is. The confidence interval is a guide that represents how sure it is possible to be about the quantity we are interested in (e.g. the effect of a policy option on an outcome of interest). The narrower the range between the upper and lower numbers of the confidence interval the more precise the estimate is and the more confident it is possible to be about the true value. The wider the range the less certain it is possible to be. The width or range of the confidence interval reflects the extent to which chance may be responsible for an observed estimate (wider intervals reflect the greater likelihood of chance being a factor). A 95% CI means that we can be 95% confident that the true size of an effect is between the lower and upper confidence limit. Conversely there is a 5% chance that the true effect is outside this range. |
How confident are we in the estimated impacts? Case example: The licensing of tobacco retailers
| The expert report commissioned by the government concerned concluded that the empirical basis for the licensing of tobacco retailers was "robust" but the basis for this judgement was unclear. The experts did not conduct, or cite, the systematic review that is referenced in Table 3, or any other systematic review as the basis for their estimates, even though a systematic review was available [ |
| The authors of the systematic review (which included a broader range of interventions and study designs) concluded: "Interventions with retailers can lead to large decreases in the number of outlets selling tobacco to youths. However, few of the communities studied in this review achieved sustained levels of high compliance. This may explain why there is limited evidence for an effect of the intervention on youth perceptions about ease of access to tobacco, and on smoking behaviour." The 'pessimistic' estimates of the benefits in Table 1 are consistent with the findings of the systematic review and were not considered in the expert report. |
The GRADE system for assessing the quality of evidence
| Evaluating the quality of evidence requires judgements about the extent to which one can be confident that an estimate of effect is correct. GRADE provides a systematic and transparent approach to making these judgements for each outcome important to a decision [ | |
| Confident that the true effect lies close to that of the estimate of the effect | |
| The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different | |
| The true effect may be substantially different from the estimate of the effect | |
| Very uncertain about the estimate | |
Is a formal economic model likely to help? Case example: The licensing of tobacco retailers
| The expert report commissioned by the government concerned included an economic analysis. This concluded that the cost per life year saved by licensing tobacco retailers and conducting compliance checks was between approximately €900 and €92 000 with a best estimate of €8 000. The authors noted that there was substantial uncertainty about their estimates and suggested focusing on the range of estimates rather than the best estimate. Nevertheless they reported exact estimates (based on the assumptions they made) and concluded that the empirical basis for recommending licensing tobacco retailers was robust. As a result policymakers who failed to read this report critically could conclude (wrongly in our opinion) that the report provided high-quality evidence that the licensing of tobacco retailers was as cost-effective as (or more cost-effective than) a wide range of clinical preventive services paid for by the government. A more systematic review of the underlying evidence [ |
Factors that can determine the importance of implementing health policies and programmes
| The following factors may sometimes be considered independently (or in combination) as criteria for setting priorities for implementing health policies and programmes: |
| • How serious the problem is -- the more serious a problem is, the more likely it is that a policy or programme that addresses the problem will be a priority |
| • The number of people that are affected by the problem -- the more people who are affected, the more likely it is that a policy or programme that addresses the problem will be a priority |
| • Benefits -- the larger the benefit, the more likely it is that a policy or programme will be a priority |
| • Adverse effects -- the greater the risk of undesirable effects, the less likely it is that a policy or programme will be a priority |
| • Resource use (costs) -- the greater the cost, the less likely it is that a policy or programme will be a priority |
| • Cost-effectiveness -- the lower the cost per unit of benefit, the more likely it is that a policy or programme will be a priority |
| • Impacts on equity -- policies or programmes that reduce inequities may be more of a priority than ones that do not (or ones that increase inequities) |
| Decisions about priorities should rest on shared criteria or reasoning such as the ideas shown above. They should also be open to inspection and they should be possible to appeal in light of considerations that stakeholders may raise. Regulation should ensure that these three conditions are met [ |