Unhealthy diets are a leading cause of death and disability globally. The WHO recommends Member States implement front-of-pack (FOP) nutrition labels to guide consumers towards healthier food choices, as part of comprehensive strategies to prevent diet-related non-communicable diseases. Interest in FOP nutrition labelling is increasing, but there is limited guidance for policymakers developing regulations necessary for effective implementation. A rapidly evolving evidence base, limited regulatory capacity and possibility of legal challenge by affected food industry stakeholders can create ‘regulatory chill’, whereby governments are dissuaded from progressive public health policymaking. We use a framework for analysing public health law and available best-practice guidance to evaluate key components of 31 FOP nutrition labelling regulations endorsed by governments up to June 2019. Analysis of regulatory form shows recent rapid uptake of label formats that are easier for consumers to understand and increasing use of mandatory legislation. However, policymakers must decide much more than whether to apply ‘stars’, ‘traffic lights’ or ‘stop signs’. The substance of effective regulation must contain strategic regulatory objectives, clear specifications for displaying the label on pack, a valid scoring mechanism and a justified scope for including foods. While there are limited data on current practice, good governance of FOP nutrition labelling regulation also requires transparency and accountability in processes of label development, implementation, evaluation and enforcement to promote continuous improvement and withstand undue commercial interference. Whether developing new FOP nutrition labels or reforming existing ones, our findings support policymakers to design and implement best-practice, evidence-informed regulation.
- food policy
- public health nutrition
- non-communicable diseases
- food labelling
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Simple, graphical front-of-pack (FOP) nutrition labels are part of the package of policies recommended by the WHO to address the growing global burden of diet-related non-communicable disease.
Food industry resistance to progressive FOP nutrition labels threatens to stifle policy innovation, creating need to support policymakers to design and implement best-practice regulation.
A framework for analysing public health law applied to 31 existing FOP nutrition labelling regulations endorsed by governments highlights strengths of current practice and areas where it could be further improved.
While public health attention has focused on label format (eg, stars, traffic lights, stop signs), regulators must also consider the legal framework used (ie, voluntary or mandatory), which foods are within scope, how foods will be scored and how labels should be displayed on pack, as well as incorporating procedural mechanisms to promote transparency and accountability at all stages of the policy cycle.
FOP nutrition labels implemented through evidence-informed, strategically designed regulation are less likely to be successfully contested in national and international courts and more likely to achieve public health impact.
Unhealthy diets are a leading cause of death and disability globally.1 Unprecedented availability, accessibility and affordability of processed and prepackaged foods is a key driver of obesity and diet-related non-communicable diseases (NCDs) including high blood pressure, cardiovascular disease, type-2 diabetes and some cancers.2 3 As part of a comprehensive policy response to promoting healthier diets and preventing NCDs, the WHO recommends that governments implement front-of-pack (FOP) nutrition labels.4–11 These simple, often graphical labels provide at-a-glance information on nutritional quality on the primary display panel of foods and beverages (hereafter ‘foods’) to complement detailed nutrient declarations on back-of-pack. A growing body of evidence suggests such labels may aid consumer understanding of nutritional quality, encourage selection and purchase of healthier foods, and promote reformulation by industry.12–15
Existing authoritative guidance supports government action but provides limited detail on the appropriate content of national FOP nutrition labelling regulation.11 16 17 Recent policy developments at a national level include a shift away from ‘softer’ positive signposts that highlight healthier options within category such as Sweden’s green ‘Keyhole’,18 towards formats such as Chile’s ‘stop-sign’ warnings19 which signal product unhealthfulness and discourage consumption, thereby potentially decreasing sales.
Resistance to these newer FOP nutrition labels can be seen in legal challenges launched or threatened under domestic and international law, including at the World Trade Organization (WTO).20–22 The potential impact of different national requirements on food trade has also prompted the international food standards agency, the Codex Alimentarius Commission (Codex), to commence negotiating further guidance on FOP nutrition labelling.23 These developments illustrate the multisectoral nature of food governance and competing authorities at play: nutrition labelling lies within the remit of the health sector but requires balancing with the interests of stakeholders in agriculture, industry and trade.16 21 24
A significant body of health research compares the efficacy of different FOP nutrition label formats (eg, stars, traffic lights, stop signs),14 25 but there has been less systematic examination of other essential features of regulation. Questions faced by policymakers include which foods FOP nutrition labels should apply to, how foods should be scored and which stakeholders should be involved in developing, evaluating and enforcing FOP nutrition labelling.
A rapidly evolving public health evidence base, limited regulatory capacity and the possibility of costly legal challenge driven by affected food industry stakeholders creates the risk of ‘regulatory chill’, whereby governments are dissuaded from progressive public health policymaking.26 To avert this risk and accelerate continued policy innovation, our aim was to provide policymakers with support to prepare evidence-informed, strategically designed and well-governed FOP nutrition labelling regulations.
We analysed current practice using a framework developed by Reeve and Magnusson for analysing and improving the performance of public health regulation.27 Building on public health and regulatory studies literature, the framework allows evaluation of multiple ‘regulatory domains’: considering the form of regulation used, its substantive terms and conditions, and the application of good governance in its development, administration and enforcement. We adapted this framework to the specific context of FOP nutrition labelling regulation by reference to recent best-practice guidance from the WHO and World Cancer Research Fund (table 1).11 16 17
To apply the framework, we created a database of existing regulations. Existing FOP nutrition labels were identified by a search of existing global policy databases and reports.16 17 28–30 We included government-led or officially supported (hereafter ‘government endorsed’) initiatives identified as FOP nutrition labelling by at least one of these sources. We adopted a broad definition of regulation to capture both voluntary FOP nutrition labels, for example, those implemented through sets of government-issued rules that industry voluntarily apply, and mandatory systems, which impose binding requirements on industry through government legislation. Inclusion of voluntary schemes acknowledges that this kind of ‘self-regulation’ is often relied on in lieu of more traditional government legislation and that public interest in their effectiveness thereby warrants their subjection to the same scrutiny. We refer to both mandatory and voluntary labelling schemes as ‘regulation’ throughout.
For each FOP nutrition label, we collated publicly available information on each component of regulation identified in the framework. Information from the primary global policy databases and reports was supplemented by targeted searches of peer-reviewed and grey literature, for example, government websites. Results are summarised in table format, and the database provided in full as online supplementary appendix 1.
For the purposes of this analysis paper, we present findings by regulatory domain to highlight strengths of existing practice and make recommendations for where and how FOP nutrition labelling regulation could be improved.
Our search of current practice identified 31 unique FOP nutrition labels, each governed by their own regulatory rules. Some jurisdictions had more than one FOP nutrition label (eg, Israel had both red warnings for specific nutrients, and a green endorsement logo), and some labels operated in more than one jurisdiction (eg, Australia and New Zealand’s Health Star Ratings (HSR)).
In total, 32 governments had endorsed some form of FOP nutrition label (figure 1). Most (23/32) of these had done so since 2010 (online supplementary appendix 1). In 2019, countries including Argentina, Brazil, Canada, Fiji, Germany, Guatemala, India, Portugal and South Africa were reportedly considering FOP nutrition labelling,16 17 highlighting the need to disseminate regulatory best-practice.
When designing regulation, an initial consideration for policymakers is selection of an appropriate legal framework (table 1).16 Mandatory FOP nutrition labels are specifically recommended by the WHO High Level Commission on Ending Childhood Obesity6 7 and provide an important way to overcome suboptimal uptake of voluntary labels.17 Despite sometimes being raised as a barrier to mandatory labels, international trade agreements governed by the WTO do allow governments to implement mandatory measures, provided regulation is crafted carefully to maintain coherence with international trade obligations.21 In each jurisdiction, policymakers must determine whether any existing law restricts implementation of a mandatory label. For example, European Union (EU) legislation may constrain EU member countries from applying mandatory national legislation.31 Where a mandatory label is not legally possible, a voluntary system can be pursued.16
While the majority of labelling schemes in current practice remained voluntary, 10 countries now have mandatory FOP nutrition labels (figure 1). Eight of these were adopted since 2014, including regulations in Ecuador,32 Iran,33 Sri Lanka,34 Mexico,35 Chile,36 Peru,37 Israel38 and Uruguay.39
For FOP nutrition labelling to promote healthier diets, policymakers must select a label format that consumers can understand and use (table 1). A significant body of public health evidence suggests formats with interpretive elements that show judgement or recommendation are most useful.11 13 14 As outlined in figure 1, these include nutrient-specific interpretive labels and multiple types of summary indicator formats.
Of 31 current FOP nutrition labels, 26 used interpretive elements. Fourteen positive signposts used subjective words (eg, good, healthier), symbols (eg, ticks, hearts) and colour to signal relative healthfulness within category. However, included elements such as the Keyhole symbol did not necessarily hold intuitive meaning (figure 1). While the marketing value of positive signposts makes them appealing to industry, a summary of recent evidence suggests they encourage consumers to overestimate healthfulness and may also facilitate price premiums on healthier options that policymakers may find undesirable for low socioeconomic consumers.17
By contrast, the past 5 years has brought rapid innovation in labels that evaluate product unhealthfulness, which appear more effective in supporting consumers to choose nutritionally favourable products.17 These include 10 nutrient-specific formats which used descriptive words (eg, low, medium, high); meaningful colour (red, yellow, green, black) and salient symbols (eg, stop signs, traffic lights) to illustrate specific nutrient content (figure 1). Recent regulation adopted in Uruguay elected to use ‘excess’ rather than ‘high in’ for specific nutrients,39 reflecting research in that context that ‘high in’ was prone to more positive connotations.40
In a similar manner, Australasia’s HSR41 and France’s NutriScore42 (now also endorsed by Belgium and Spain) indicated both healthfulness and unhealthfulness but did so on a customisable continuum to summarise nutritional quality overall. Nutri-Score used colour to reinforce its evaluation (ie, A was dark green to signify healthiest)42 whereas HSR allowed manufacturers to display the logo in any colour.41 No jurisdiction had yet extended this focus on evaluating unhealthfulness to providing only a summary negative signpost (figure 1).
The remaining five labels (figure 1) were non-interpretive, that is, presented monochrome numerical information. While preferred by industry, consumers cannot understand and use such information,11 13 14 particularly those with lower nutrition literacy, education or members of minority ethnic groups.11 For FOP nutrition labelling to effectively guide consumers towards healthier choices, policymakers should avoid non-interpretive label formats.
Effective implementation of FOP nutrition labelling also requires policymakers to ensure sufficient attention to Domain Two, the substantive terms and content of regulation. In this domain of regulatory substance, loopholes and gaps in current practice provide insight for strengthening future regulation.
The objectives of regulation provide the basis by which policy ‘success’ will be judged, both in routine evaluation and in the event of legal challenge.16 21 Strategic regulatory objectives should reflect measurable pathways of effect, for example, changes in consumer understanding, behaviour and/or food composition (table 1) demonstrable by short-term evaluation. While improved food labelling may contribute to broader goals, for example, prevention of NCDs or longer-term changes in obesity prevalence, difficulty in producing short-term evidence of these outcomes makes them less suited as explicit objectives of regulation.16 21
Current practice summarised in table 2 aligns with WHO Guidance on the objectives of FOP nutrition labelling.11 Where identified, all regulations specified a measurable consumer-focused objective that is, informing and/or helping them make healthier food choices. Uruguay’s law was even more strategic; its objective was to allow consumers to ‘identify foods with excessive amounts of specific nutrients’,39 a threshold foreseeably easier to demonstrate. Seventeen interpretive labelling regulations also contained explicit reference to the additional benefit of incentivising industry reformulation (table 2).
Specifications for displaying FOP nutrition labelling on pack
Regulation can specify requirements to enhance visibility and salience of the FOP nutrition label on pack. Examination of current practice identified at least some display specifications in 22 FOP nutrition labelling regulations. Specifications included size, contrast, colour and/or font (table 2). Where display was not explicitly required on the front or principal panel, it sometimes occurred elsewhere (eg, Ecuador),16 weakening visibility.
Only four regulations directed uniform placement, for example, top right (table 2). More common were minimum space requirements around the FOP nutrition label; the Nordic Keyhole also specified separation from competing claims (eg high in protein).18 Chile’s law required removal of marketing tools on pack (eg cartoon characters), for foods carrying a stop sign label.19 Six regulations incorporated written government endorsement (eg, Ministry of Health); two provided directions for use (eg avoid excessive consumption)(table 2). These progressive examples, along with lessons from refined display specifications in settings such as tobacco control,43 suggest potential for future regulatory innovation.
Included nutrients and/or food components
As part of a comprehensive approach to NCDs, nutrients and/or food components included in regulation should relate to evidence of diet-related risk.1 Current WHO guidance also suggests they be focused on nutrients already required to be declared on back-of-pack.11
Information on current practice was identified in the regulations of 30 labels (table 2). Twenty-eight included one or more nutrients associated with increased NCD risk: sodium (28); saturated fat (22), total sugar (21), trans fat (8), total fat (8) and added sugar (6).
Fewer regulations incorporated food components associated with decreased NCD risk: fibre (15), whole grain (5) and ‘fruit, vegetable, nut and legume’ content (2). This may reflect caution in highlighting packaged sources of these components over whole food counterparts.11
Other components included in current regulations were energy (14), artificial sweeteners (4), calcium (3), protein (3), cholesterol (1), unsaturated fat (1), caffeine (1) and added preservatives (1). Zambia indicated it would address NCDs and micronutrient deficiency,44 though nutrient criteria were not identified. To mitigate the risk of potential challenge, policymakers should ensure all inclusions are informed by health evidence.
Nutrient profiling criteria or scoring system
Nutrient profiling is the science of classifying or ranking foods according to their nutritional composition for reasons related to preventing disease and promoting health.17 For FOP nutrition labelling to successfully guide consumers towards healthier choices, regulation must specify a valid set of nutrient profiling criteria, that is, ones that appropriately evaluate nutritional quality.11 16 17
Nutrient profiling criteria were identified for 22/26 interpretive labels. Positive signposts used nutrient thresholds that varied by category; some had >60 categories (table 2). Nutrient-specific interpretive labels also used nutrient thresholds but across broader categories of ‘foods’ and ‘drinks’ to determine eligibility for a label (eg, stop sign) or its colour coding (eg, red, orange, green). The two overall spectrum ratings used algorithms to score overall nutritional quality, for example, HSR combined points from up to seven food components to generate an overall rating of 0.5–5.0 in one of six categories.41
To produce meaningful scores, regulation must specify a reference amount of the product to be used. Most regulations (20/31) applied criteria per 100 g/100 mL (table 2), consistent with WHO recommendation that this is most useful to facilitate standardised comparisons between products. ‘Per serving’ was used always or sometimes as a basis for nutrient profiling in 12 regulations, with potential to cause consumer confusion.11
Validation of nutrient profiling criteria is important to assess whether they correctly classify product healthfulness. However, some form of validity testing was identified for only six labels (table 2). Five criteria had been assessed against other measures of healthiness (eg, dietary guidelines); only three had been subject to stronger predictive testing of links between scoring criteria and health outcomes.45 Our results support existing calls to improve the science and selection of nutrient profiling criteria to ensure FOP nutrition labelling promotes genuinely healthier choices.11 45
Scope of products included in regulation
WHO guidance suggests regulations apply across most packaged foods to facilitate product comparisons and improve familiarity with the FOP nutrition label.11 Most current regulations (26/31) aligned with this guidance, applying broadly to packaged foods and drinks that carried a nutrient declaration. Some regulations applied beyond packaged food: six applied to unpackaged foods (eg, fruit, vegetables, fresh meat and seafood); five applied to meals served in restaurants or other catering services (table 2).
WHO guidance also suggests FOP nutrition labelling may not be appropriate for some foods.11 While exclusions were often not clearly specified in current regulation, no FOP nutrition labelling was allowed on infant formula; other frequent exclusions were foods for special dietary or medical uses, supplements and alcoholic beverages (online supplementary appendix 1). Foods not displaying nutrient declarations (eg, herbs, tea, small packs) were commonly exempted (but not necessarily excluded) (table 2).
Some exclusions varied by label format: for example, Chile and Uruguay excluded products with no added sugars, sodium or saturated fat, meaning intrinsic sources of these nutrients did not carry stop-sign warnings.19 39 Conversely, the positive Keyhole was not permitted on snacks.18
Findings suggest some flexibility for policymakers to determine national scope, provided decisions are justified by health evidence and apply equally to local and imported products.21
Recognising no single action will be sufficient to address the global burden of unhealthy diets; policymakers should support and frame FOP nutrition labelling as part of a comprehensive suite of measures to promote healthier diets.16 21 To maximise public health impact, the substance of regulation should be aligned with existing measures, for example, food-based dietary guidelines (table 1).11
We identified 16 FOP nutrition labels that were supported by education campaigns to promote label use and/or broader nutrition messages, but only six that explicitly identified FOP nutrition labelling as part of broader nutrition, NCD or development plans (table 2). There is potential for innovative regulation to extend utility of FOP nutrition labelling beyond the point of food purchase: six regulations integrated labelling with other interventions, including Chile who stopped foods carrying labels from being sold in schools or marketed to children,19 and France’s agreement to make Nutri-Score mandatory in all food advertisements from 2021.42
In addition to form and substance, good governance of the processes by which regulation is developed, implemented, evaluated and enforced is critical to consumer confidence in FOP nutrition labelling (table 1).27 A summary of data identified on current practice is provided in table 3. The limited nature of available data suggests need for greater attention from policymakers and/or increased transparency in activities undertaken.
Drafting regulatory rules and scheme design
WHO recommends that governments initiate FOP nutrition labelling and retain specific responsibility for setting regulatory objectives, scope and nutrient scoring criteria (table 1).11 Government-led development is perceived as more credible by consumers.17
All mandatory and most voluntary current regulations were initiated by governments, typically through health ministries or statutory food authorities. Five governments noted early engagement across sectors (eg, trade, agriculture, education)(table 3), which is recommended to promote whole-of-government coordination.16 21 Three voluntary regulations were initiated by civil society, two by industry and one was multistakeholder.
During policy development, government-led stakeholder engagement can facilitate due process and assist development of feasible and acceptable regulation.11 At the same time, there is a need to ensure that public health policymaking is conducted with safeguards to appropriately manage conflicts of interest.46
We identified at least some detail on stakeholder engagement for 19 FOP nutrition labels. Mandatory regulations followed standard procedures for legislative development. In jurisdictions with functioning rule of law, these typically embed principles of good governance such as due process and public consultation. While useful in promoting accountability, these procedures are not necessarily failsafe: in Mexico, lack of transparency during public consultation raised concern that industries were more heavily consulted than academics or civil society organisations.47 Mexico subsequently adopted a non-interpretive label (figure 1). Voluntary regulations were also frequently preceded by public consultation, but in limited cases also elevated industry to collaborator or member of committees developing the substance of regulation (table 3). Beyond a right to be heard through consultation, these collaborative arrangements create additional need for safeguards to ensure health objectives are not undermined by commercial interests.
The particular need to maintain the scientific integrity of committees developing nutrient profiling criteria is recognised in WHO recommendations that this process run parallel but independent and siloed from broader stakeholder engagement.11 Where detail was identified for current regulations, only 4/22 governments engaged industry in nutrient profiling development (table 3). They include Australia and New Zealand’s HSR system, where a government-commissioned independent review recently recommended industry be distanced from future nutrient profiling updates.41 The need for nutrient profiling to remain free from commercial interests can be seen elsewhere in the industry-led Choices Programme, which created a separate ‘independent scientific committee’ specifically for this task.48
Unlike the Framework Convention on Tobacco Control’s Article 5.3 in a tobacco control context,49 there is currently no binding international law requiring government to exclude the food industry from health policy development. Available guidance includes a proposed approach for prevention and management of conflicts of interest in national nutrition policymaking discussed by the WHO Executive Board in 2018.46 In Canada, where FOP nutrition labelling regulations are currently being developed, government has introduced new standards for transparency of stakeholder communications for healthy eating initiatives. In addition to publishing responses to formal consultations, all meetings and correspondence with stakeholders including industry are published on the government’s website. Any documents provided during meetings are also accessible to the public upon request.50 Divergence in current practice more broadly highlights the need for further guidance for policymakers on appropriate engagement with the food industry in the governance of FOP nutrition labelling.23
To promote accountability, labelling regulations should be administered by government or an independent body with requisite authority to monitor and enforce regulation (table 1). Evaluation of current practice suggested governments administered 25/31 current labelling schemes. Three were administered by civil society organisations, which were independent but may lack authority or resource to enforce regulation (table 3). HSR and Choices used multistakeholder committees, again creating need for conflict of interest safeguards. In the context of administrative committees, appropriate measures could include conducting meetings publicly with publicly available minutes, and stakeholders recusing themselves from decisions where a conflict exists (eg, where an industry representative is required to assess the compliance of one of their members with regulation).
Monitoring and evaluation
Structured, regular review ensures regulation is meeting its objectives and supports continuous improvement. Best-practice requires policymakers to set a framework during development that includes baseline data, performance indicators and appropriate timeframes (table 1).
The absence of systematic monitoring and evaluation with publicly available outcomes was a key limitation of current practice in our evaluation. Government-supported monitoring was reported for just over half of regulations; only one-third of regulations had been subject to some form of evaluation. There was suboptimal monitoring of outcomes necessary to demonstrate achievement of regulatory objectives: 10 labels monitored consumer understanding and use, 7 monitored reformulation. Only 11 monitored industry uptake, necessary to judge impact and compliance with regulation (table 3).
Some newer regulations showed elements of stronger practice. HSR had a government-appointed independent reviewer with publicly available Terms of Reference.41 Nutri-Score was implemented with publicly funded evaluation using a variety of data sources.42 Governments of Chile and Israel proposed evaluation with independent academics;36 Israel also planned to obtain sales data (online supplementary appendix 1).
FOP nutrition label performance was also subject of ad hoc independent research. For example, the HSR website noted 45 peer-reviewed papers between 2014 and 2019.41 While contributing valuable insight, this work does not obviate the need for systematic government-supported evaluation.
Specific evaluation of nutrient profiling criteria is necessary to ensure regulation evolves with nutrition science.11 Only one-third of current regulations had relevant mechanisms to trigger this process. Legislation in Chile, Israel and Peru incorporated progressively lowering nutrient thresholds to incentivise continuing industry reformulation; Finland had also updated salt warning legislation. Five positive signposts reviewed criteria at prespecified intervals; Keyhole criteria had been updated five times.18 HSR’s algorithm was a focus of its 5-year review.41
Effective enforcement of regulation promotes compliance with regulation (table 1). Sanctions or rewards were identified in only around half of FOP nutrition label regulations but provided insight into the range of options available (table 3). Ten labels licensed products prior to market sometimes with associated cost (online supplementary appendix 1), though utility of this feature may be practically limited to positive signposts. Other incentives for voluntary uptake included listing participating companies on government websites.
Once on shelves, at least seven regulations audited products for compliance. Sanctions for non-compliance varied widely. Positive signposts could withdraw approval for use. Four labels used written requests to manufacturers for amendment (table 3). Non-compliance with Ecuador’s label could result in cancellation of advertising permits.32 In South Korea, Sri Lanka and Uruguay, general sanctions under relevant Food Acts applied, for example, fines and potentially jail sentences (online supplementary appendix 1). Even in voluntary systems, legal action was possible, for example, to protect misuse of trademarked logos. HSR was the only system identified that had its own complaints handling mechanism.41
For all systems, lack of identified information on whether sanctions are being used suggests potential to strengthen enforcement action and/or improve transparency of activity.
Development and implementation of FOP nutrition labelling regulation requires much more than the selection of ‘stars’, ‘traffic lights’ or ‘stop signs.’ While growing government endorsement of more effective label formats and use of mandatory legal frameworks holds public health promise, policymakers must still ensure the substance of regulation is strategically drafted to support policy objectives. They must also apply principles of good governance in regulatory processes to protect health policymaking from undue commercial interference, support continuous improvement and retain the trust of consumers as end users.
This paper applies a comprehensive public health law framework to demonstrate how factors often considered outside the realm of public health such as regulatory drafting and good governance can support or undermine health outcomes. This study benefited from its global remit but was limited by reliance on publicly available information, particularly on governance processes. Whether developing new FOP nutrition labels or reforming existing ones, these findings provide support for policymakers to design and implement best-practice, evidence-informed regulation.
Handling editor Seye Abimbola
Twitter @alikjones, @@ClionaNiMhurchu
Correction notice This article has been corrected since it published Online.
Contributors AJ, BN and AMT designed the study. AJ conducted the research and wrote the first and subsequent drafts. BN, BR, CNM and AMT provided input on the first and subsequent drafts.
Funding AJ is funded by an Australian Government Research Training Stipend.
Disclaimer The HSRAG did not have any role in the study design, data collection and analysis, decision to publish or preparation of the manuscript.
Competing interests CNM is a member of the New Zealand Health Star Rating Advisory Group (HSRAG).
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement All data relevant to the study are included in the article or uploaded as supplementary information.