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Original Article

Legislating for health: Locating the evidence

Ray Pawsona,*, Lesley Owenb, and Geoff Wongc

aSchool of Sociology & Social Policy, University of Leeds, LEEDS LS2 9JT, UK.E-mail: r.d.pawson@leeds.ac.uk

bNational Institute for Health and Clinical Excellence (NICE), MidCity Place, HighHolborn, London WC1V 6NA, UK.E-mail: Lesley.Owen@nice.org.uk

cResearch Department of Primary Care and Population Health, Royal Free Campus,UCL, London NW3 2PF, UK.E-mail: g.wong@ucl.ac.uk

*Corresponding author.

Abstract This article examines the timorous courtship between publichealth law and evidence-based policy. Legislation, in the form of directprescriptions or proscriptions on behaviour, is perhaps the most powerful toolavailable to the public health policymaker. Increasingly, the same policymakershave striven to ensure that interventions are based soundly on a secure evidencebase. The modern mantra is that the policies to follow are the ones that havebeen demonstrated to work. Legislative interventions, involving trade-offsbetween public benefit and private interests, present formidable challengesfor the evaluator. Systematic reviews of their overall efficacy, the main tool ofevidence-based policy, are in their infancy. The article presents a design for suchreviews using the example of a forthcoming synthesis on the effectiveness ofbanning smoking in cars carrying children.Journal of Public Health Policy (2010) 31, 164–177. doi:10.1057/jphp.2010.5

Keywords: evidence-based policy; public health law; smoking bans; realistsynthesis

Introduction

The apparatus of evidence-based policy, systematic review, meta-analysis, and so on is now considerable.1 Legislative interventions,in general and in public health policy, remain somewhat distancedfrom such scrutiny – unfortunately – because usage of the lawprovides a seemingly powerful tool for affecting change. In the case

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of public health, a domain where progress is often slow andpiecemeal, the argument has become compelling.2 With the nationalcoffers dwindling, growing sentiments suggest it is time to introducemore immediate curbs on people’s behaviour.3 A handful ofexamples of the varied public health domains in which suchlegislation already operates appear in Box 1. The big issue iswhether we have evidence to show that they work and the data todecide whether they should be extended.

First Principles

This article attempts to answer this grand challenge with a researchdesign. It considers how one might go about collecting andsynthesizing evidence to help judge the efficacy of a public healthlaw to regulate behaviour. There is a keen debate underway aboutthe best strategy for conducting such reviews.4–6 We make noattempt to rehearse it here other than to mention that the methodsassociated with the Cochrane Collaboration, which have proved sovaluable in the clinical domain, are often found to be unworkable inother fields of public policy.7–9 And so it is with public healthlegislation.

K The first stumbling block is the ‘gold-standard’ aspiration that theevidence base should be founded upon studies employingrandomized controlled trials. Randomization is impossible in thecase of legislative interventions. The law is the law. We cannotcontrive experiments in which the experimental group iscompelled legally to drive around wearing seat belts while acontrol group is absolved of the requirement.

Box 1: Required and prohibited behaviour in public health legislation

Compulsory seat belts, corporal punishment bans, smoking-free bars, workplaces and

public places, fines for underage tobacco/alcohol sales, banning hand-held phone usage in

cars, prohibiting driving while intoxicated, compulsory motor/cycle helmets, compulsorynutrition labelling, compulsory vaccination/screening, limiting sales of non-prescription

medications, firearms control and amnesties.

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K Another difficulty is the requirement that synthesis should focuson precise outcome indicators, aggregated across primary studiesin order to produce authoritative ‘net effect’ calculations ofprogramme efficacy. The measurement of health behaviour ‘in thefield’ is infinitely more demanding than in the laboratory test.Consider monitoring a ban on smoking in cars carrying childrenand the mighty surveillance operation that would be needed todiscern every furtive puff and cocooned child.

K A third and major conundrum concerns the paramount need forcommunal endorsement in legislation. This is highlighted in thethoughts of the suffragette Carrie Chapman, ‘No written law hasever been more binding than unwritten custom supported bypopular opinion’. Adherence to a law (unlike responses tomedication) is strongly conditioned by levels of public support,which are often variable and fickle.

K A fourth limitation is set by the incremental nature of legislation.In mature jurisdictions, new laws amount to extensions andamendments to existing law. What is most often needed by way ofevidence comes from research on the augmentation rather than thecore. In evaluations of smoking bans, we find that studies arelegion – except where they might now be needed, as in the recentlymuted extension to cars carrying children.

What then might be a more appropriate method for synthesizingevidence on interventions, which are hard to manipulate and control,difficult to observe and measure, sensitive to context and culture,and which mutate under amendments and increments? There is agrowing number of alternatives,1 the one pursued here being knownas realist synthesis.5 Again, we refrain from technical details,concentrating instead on its organizing principles.

The core idea is to treat the review of evidence as a form of‘programme theory’ evaluation. Public health interventions arebrought to life on the basis of considerable forethought. A set ofpreliminary ideas, ambitions, expectations, hypotheses or ‘pro-gramme theories’ is marshalled postulating that if certain resources(sometimes material, sometimes educational, sometimes environ-mental, and sometimes legislative) are provided then they willinsinuate peoples’ reasoning to a sufficient extent that a change tohealthier behaviour will follow. Before they are implemented (and

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especially when they impact on constitutional matters), new policiesare given a ‘plausibility check’ – sometimes under formal consulta-tion and sometimes under informal debate. The programme theorythat emerges thus includes ideas about what is going wrong, ideasabout how to remedy the deficiency, ideas about how the remedyitself may be undermined and, most importantly, ideas about how tocounter these counter threats. The success of a programme is thus amatter of the credibility of its component conjectures.

Realist synthesis can capitalize on this scenario, deepening andformalizing the plausibly check by putting the constituent ideas toempirical scrutiny. It begins by eliciting the key theories assumed inthe construction of the intervention and then goes on to test theiraccuracy and scope – the programme is supposed to work like thisbut what has happened in practice? Empirical evidence is examinedwith the task of discovering where the policy architects’ assumptionshave proved justified and where have they been dashed.

Legislative Interventions – A Basic Programme Theory

To many ears, talk of the ‘theory’ behind legislative interventionsto regulate personal behaviour is fanciful. The very idea is to stoppussyfooting around with advice, education and sloganeering, andto compel people to behave. In practice, however, law making is lessmuscular and more nuanced. It is a considered process (Figure 1),inching its way though three broad stages:

K identification and precise codification of behaviours deemedresponsible for poor health;

K drafting regulations under the law to prescribe healthy/proscribeunhealthy activities; and

K organizing enforcement to mop up recalcitrant behaviour andreinforce compliance.

Figure 1 introduces key analytic distinctions but is little morethan a description of the legislative platform. The real ‘theory’ tolegislative change lies with the ability to anticipate and deal with aseries of predictable problems running through this implementationchain. These ‘threats’ occur at each stage: (i) failure to asses properlythe health risks associated with a particular behaviour; (ii) poor

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drafting of the legislation so that loopholes remain, allowing thetargeted behaviour to continue; and (iii) inability to marshalresources to adequately enforce compliance with the new laws. Aschematic description of such constraints is catalogued in thissection, with illustrations of the unanticipated consequences thatmight flow from them. Figure 2 superimposes each threat onto thebasic legislative platform. It represents the ‘programme theory’ thatwe postulate may be put to use in any review of any application ofpublic health legislation intended to regular behaviour. Themechanics of such a review appear in the next section. First, wedescribe the legislative minefield.

1. Problem misidentification. This refers to the failure of the initialtheory – the basic diagnosis of the ‘problem’. Is the behaviour

Behaviours leading to poor health

Legislation to proscribeunhealthy/unsafe activities or

prescribe healthy/safe behaviour

2. COMPULSION

Penalties/ threat of penalties forfailure to comply with new

legislation

3. ENFORCEMENT

Compliant behavioural change

1. IDENTIFACTION

Figure 1: Legislative change – basic programme theory.

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targeted in the legislation really the major contributor to thepublic health problem? In relation to corporal punishment bansto reduce child maltreatment, a case is made that a lessersymptom is being addressed and that mental health problems,marital conflict, ‘mercy killing’ and neglect are the majorcontributors to child homicide.10 Similarly, it may be that firearmamnesties harvest only defunct and defective weapons.11

2. Criminalization and blame: Subjects pursued and prosecutedunder new legislation may become toughened in their attempts topursue illegal behaviour. The classic example of this unintendedeffect lies in the area of substance abuse. Wolfson and Houriganargue for an ‘amplification of deviance’ hypotheses in the case ofyoung adults (under 21 years) prosecuted under a United Statesliquor-drinking ban and the tobacco purchase legislation.12 Theypoint to evidence that arrest and violations continued to increaseafter legislation.

3. Compensating and displaced behaviour. This refers to theproblem that legislation may lower risks, only for the influenceto be countermanded by the subject transferring to other riskybehaviours. Low fat/low calorie labelling may lead to overeatingof seemingly healthy foods, especially those products without anatural ‘serving’ control.13 Drivers who wear seat belts may feelsafer and drive faster and more carelessly than they wouldotherwise do.14 Drivers may over-hasten when clear of enforce-ment cameras and road humps.15

Criminalisation

Compensating behaviour

Lack of public support

Low perceived threat of punishment

Lobby group opposition

Problem misidentification

Insufficient enforcement resources

Identification

Enforcement

Obfuscating the new regulations

Compulsion

Figure 2: Threats to legislation.

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4. Lobby group opposition. Vested interests do not lie down and diein the face of new legislation. Magzamen and Glantz report ontobacco industry tactics to repeal and undermine a Smoke-freeWorkplace Law.16 Industry attempted to obstruct its passage ongrounds of (a) awaiting further evidence on the utility of a‘ventilation solution’, and (b) economic arguments about the needfor delay to minimize implementation costs, to recruit new staff,and to offset the loss of business.

5. State of public support/opinion. An unpopular law will becomeembroiled in implementation discord. At the other extreme, a lawthat simply imitates popular opinion will make little difference.Alcohol restriction is generally unpopular and generates diversemeans to circumvent it.17 By contrast, some have argued thatdeclining support for corporal punishment allowed Swedishlegislators to ban it – rather than the law promoting attitudinalchanges.18 Somewhere in the middle is the case of smoking bansin, say, restaurants – these seem to be relatively easy to implementand work because they have often caught a growing wave ofsupport.19

6. Obfuscating new regulations. Opponents may pick and choose inthe face of complex legislation. ‘Fake compliance’ may be aproblem in these circumstances. Wansink and Chandon discov-ered that products required to carry fat and calorie andcarbohydrate and sodium information are often promoted as‘healthy’ in respect of their best performing characteristic (whichis often the odd one out).13

7. Low perceived threat of enforcement. Laws may be ineffectual ifmiscreants believe they are unlikely to be caught or prosecuted.Drivers’ use of hand-held phones declined in the first monthsafter a New York City ban, but the decrease almost totallydissipated during the subsequent year.20 The reason is perhapsthat the offence is brief and, in the subject’s mind, unlikely tobe witnessed. Turner and Gordon’s study of pupil’s perception ofschool smoking bans indicates that many youths regard enforce-ment regimes as tokenistic.21

8. Insufficient enforcement resources. Laws may be ineffectual ifthey are hard to police. Police routinely report that enforcementof seat belt and hand-held phone laws are wasteful of limitedresources.22 Jacobson and Wasserman compare differential

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rates of enforcement across tobacco control laws, with cleanindoor air regulations being rarely policed, while teen access lawsreceived a significant amount of vendor compliance checks.23

Locating the Right Evidence: The Stuff of SystematicReviews

It is vital to our argument that the status of Figure 2 and the purposeof the accompanying illustrations are made clear. The examples, thevignettes provided in the figure, are not forwarded as decisivenuggets of evidence; they are not deemed fatal flaws to the laws inquestion. The point is that they are potential and indeed well-knownthreats to the success of the legislation. Any legislator worth hersalt will be aware of them and will try to countermand them, andthe ensuing battle of wits and wills dictates the success or failure ofany new law. Laws are not drafted overnight. A case is made for thelegislation and cases (such as those above) are then made againstthem. Effective laws anticipate the objections and the ensuingprovisions consist of a package of direct measures as well ascountermeasures against the threats.

This brings us to our key point. If reviewers wish to gauge thelikely success of a new application of a law, if they want to findout what works in legislation, they must follow the fortunes of thebattle of ideas to date. Policymakers frame laws knowing quite a bitabout confounding effects and about how to circumvent them byanticipatory and supplementary legislation. The state of play of suchmoves and countermoves, minutely researched, is the stuff of publichealth systematic reviews. Evidence searches go beyond theidentification of schemes and programmes and are led by keywordsearches framed in terms of the points of contention in theimplementation chain – ‘criminalization’, ‘displacement’, ‘enforce-ment’, ‘public support’, and so on. A review becomes systematicwhen it has harvested and scrutinized evidence in respect of each ofthe programme theories.

Some brief examples, again mere vignettes, follow in order todemonstrate the penetration to the next level of empirical evidence.What do studies reveal about ways of countermanding some ofthe most substantial threats to legislation? No attempt is made to

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cover the entire model here – we examine only four of the abovethreats. The point is to light the way into the deeper recesses ofevidence.

(a) Criminalization and blame. There is some evidence to suggestthat the ‘amplification of deviance’ can be avoided by carefulspecification of victims and beneficiaries in promoting thelegislation. Positive strategies may be: (a) Emphasizing the‘benefit to the blameless’ in rationalizing a curb. Perdue et almake the case that coercive measures aimed at the individual(this ban is in your benefit to prevent you from smoking) mightwork less well than those aimed at protecting others (this banwill protect non-smokers from the dangers of second-handsmoke);24 (b) Pursuing the idea of ‘shared responsibility formisdeeds’. Grube and Nygaard report on how fines and threatsof fines for retailers as well as underage customers seem to quellillegal purchases of alcohol.25

(b) State of public support. This may be harnessed by an incrementalapproach to legislation, by ‘catching the wave’ of publicsentiment. An example is the claim that smoking bans aremore effective if they proceed from transport to workplace tobars to cars (from public to private spheres).16 A similar claim ismade about public willingness to comply with enhancedenforcement regimes about seat belt usage after the first waveof evidence (about injury and death reduction) had gainedcurrency.26

(c) Lobby group opposition. The potential response here seems to be‘point-by-point counter intelligence’. Magzamen and Glantz giveexamples of how tobacco company propaganda was directlycountered during the passage of US smoke-free legislation(evidence-based counter-campaigns discrediting ideas aboutdamage to turnover in small business).16 Tong and Glantzsearched 50 million pages of tobacco industry documentation onsecond-hand smoke, deconstructing the tobacco industry’sstrategy of infiltrating the design and interpretation of cardio-vascular studies.27

(d) Insufficient enforcement resources and low perceived threat.Possible strategies here, taken from criminology, to improveenforcement in a resource-neutral way include: (i) The ‘benign

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big gun theory’: about conveying to the public the ideathat direct enforcement is an available weapon, even if it isfrequently holstered. There is some evidence in the area ofdrink-drive and seat belt legislation that primary enforcement(the capacity to stop potential offenders on suspicion) worksbetter than secondary enforcement (checking alcohol/seatbelt after some traffic offence);26 (ii) The ‘blitzes andcrackdown theory’: this is about keeping the law in the publiceye by periodic high-profile, high-yield but short-term enforce-ment. Smith et al report on the mixed success of such‘clean-ups’.28

Realist Synthesis in Practice

Having identified the appropriate raw materials for a programmetheory synthesis, we turn to a strategy for an in-depth review, usingthe burgeoning example of smoking bans in cars carrying children.As noted, such bans are in their earliest phases in only a smallnumber of jurisdictions in North America and Australia, and veryfew formal evaluations have been published. However, it is perfectlypossible to ‘review the evidence’ on the ban by interrogatingthoroughly all of its component theories. Here, we focus on justthree elements from Figure 2, our analysis once again beingillustrative rather than definitive.

1. What is the extent of the problem and has it been correctlyidentified? A review here would no doubt begin with two papersby Rees et al29 and Edwards et al.30 These studies use a portablemeasuring apparatus mounted in the rear seat of a car, measuringairborne particulates. A typical finding reports particulate levelsof 272mg/m3(rather worse than those found in studies of smokybars). This debate and the evidence does not end there, of course,a frequent counter argument cites the idea that smokers generallyincrease ventilation when carrying non-smoking passengers.The Rees and Edwards papers begin to cover this angle withfurther data reporting ‘open-window’ toxicity levels down bythree quarters (but still dangerous). Another paper by Ott et al,using measures of ‘air change’ in a greater range of ventilationcondition (windows/air conditioning/speed/vehicle), emerges with

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rather different conclusions – citing a typical 12-fold increase inrate of air change with a single window open by 3 inches.31

Another sub-theory to be explored here is the ‘dose-response’counter argument about fleeting and, therefore, potentiallyinsignificant exposure in short trips. A survey by Panagiotakoset al reports that a significant proportion of the risks fromtobacco toxins peak at relatively low levels of exposure.32 Asomewhat contrasting body of evidence is explored by Cook andStrachan, concluding there is a complex dose–response relation-ship, with second-hand smoke associated with different preva-lence rates for different diseases at different stages of childdevelopment.33 The point here, is that although there is littleclinical disagreement that second-hand smoke causes diseases, theevidence is contested on the extent and immediacy of therelationship, and the reviewer has to collate and transpose thatevidence to the car’s back seat.

2. Is the tobacco industry likely to oppose such legislation? Thislobby group has managed to delay and dislodge many otherrestrictions on smoking. Have they and are they likely to actagainst smoking in cars? Unlike the risk question, this is a mucheasier programme theory to explore. Indeed the reviewer may beable to call immediately on previous research asking the samequestion. Freeman et al report on the Australian experience:‘Unlike all other advocacy for smoke free areas, this debate wasnot contested by the tobacco industry or other groups motivatedby the potential to see restrictions reduce sales and furtherdenormalize use. Indeed, one tobacco company was supportive ofthe legislation’.34 A plausible theory for such muted opposition isthat the smoking lobby prefers to declaim a ‘freedom of choice’agenda, but is likely to demur in the face of the mighty pretext of‘protecting vulnerable children’. This further proposition is itself,of course, open to test and review.

3. Is enforcement feasible and effective? On this issue there isvirtually no available data pertaining directly to the policing ofsmoking in cars. But, in a theory-based review, useful inferencesmay be drawn from evidence on other hard-to-enforce, in-carbans such as for mobile phones and seat belts. Again, we confronta somewhat collateral and highly mixed evidence base. Johalet al’s UK observational study found that drivers’ hand-held

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phone use fell by a half a few months after the law took effect.35

McCartt and Geary’s research conducted in the United Statesfound a collapse in compliance in the longer term.20 Theambiguities here would need to be further explored in a fullreview of such ancillary measures as: the efficacy of self-policingthough the surveillance of fellow drivers, the utility of crack-downs and repeat publicity, and so on.

We trust that these glimpses of the very different bodies of salientevidence demonstrate the potential of a theory-driven review – not tomention the considerable burden of having to traverse so manydiverse studies.

About the Authors

Ray Pawson is Professor of Social Research Methodology at theUniversity of Leeds, United Kingdom. He is best known for his writingon evaluation methodology and evidence-based policy; publicationsinclude A Measure for Measures (1989), Realistic Evaluation (1997)and Evidence-Based Policy: A Realist Perspective (2006).

Lesley Owen is a senior analyst at the National Institute for Healthand Clinical Excellence, an independent organization responsiblefor providing guidance on promotion of good health and preventionand treatment of ill health in England.

Geoff Wong is a family physician and a clinical lecturer in PrimaryCare at UCL, United Kingdom. His main research interests are in thesynthesis of evidence from complex interventions, with a specificfocus on the use of realist synthesis and medical education.

The authors are embarking on a UK Economic and Social ScienceResearch Council-funded project aiming to review the efficacy of aselection of interventions listed in this article.

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