| Literature DB >> 30417067 |
Greig Inglis1, Daryll Archibald1, Lawrence Doi1, Yvonne Laird1, Stephen Malden1, Louise Marryat1, John McAteer1, Jan Pringle1, John Frank1.
Abstract
There is increasing interest amongst researchers and policy makers in identifying the effect of public health interventions on health inequalities by socioeconomic status (SES). This issue is typically addressed in evaluation studies through subgroup analyses, where researchers test whether the effect of an intervention differs according to the socioeconomic status of participants. The credibility of such analyses is therefore crucial when making judgements about how an intervention is likely to affect health inequalities, although this issue appears to be rarely considered within public health. The aim of this study was therefore to assess the credibility of subgroup analyses in published evaluations of public health interventions. An established set of 10 credibility criteria for subgroup analyses was applied to a purposively sampled set of 21 evaluation studies, the majority of which focussed on healthy eating interventions, which reported differential intervention effects by SES. While the majority of these studies were found to be otherwise of relatively high quality methodologically, only 8 of the 21 studies met at least 6 of the 10 credibility criteria for subgroup analysis. These findings suggest that the credibility of subgroup analyses conducted within evaluations of public health interventions' impact on health inequalities may be an underappreciated problem.Entities:
Keywords: Equity and public health interventions; Health inequalities; Health inequities; Policy impact by socioeconomic status
Year: 2018 PMID: 30417067 PMCID: PMC6214868 DOI: 10.1016/j.ssmph.2018.09.010
Source DB: PubMed Journal: SSM Popul Health ISSN: 2352-8273
Credibility criteria for credible subgroup analyses.
| Subgroup analysis credibility criteria | Description (from |
|---|---|
| Is the subgroup variable a characteristic measured at baseline? | Subgroup variables measured after randomisation might be influenced by the tested interventions. The apparent difference of treatment effect between subgroups can be explained by the intervention, or by differing prognostic characteristics in subgroups that appear after randomisation. |
| Was the subgroup variable a stratification factor at randomisation? | Credibility of subgroup difference would be increased if a subgroup variable was also used for stratification at randomisation (i.e. stratified randomisation). |
| Was the hypothesis specified a priori? | A subgroup analysis might be clearly planned before to test a hypothesis. This must be mentioned on the study protocol (registered or published) or primary trial, when appropriate. Post-hoc analyses are more susceptible to bias as well as spurious results and they should be viewed as hypothesis generating rather than hypothesis testing. |
| Was the subgroup analysis one of a small number of subgroup analyses tested (≤5)? | The greater the number of hypotheses tested, the greater the number of interactions that will be discovered by chance, that is, the more likely it is to make a type I error (reject one of the null hypotheses even if all are actually true). A more appropriate analysis would account for the number of subgroups. |
| Was the test of interaction significant (interaction | Statistical tests of significance must be used to assess the likelihood that a given interaction might have arisen due to chance alone (the lower a P value is, the less likely it is that the interaction can be explained by chance). |
| Was the significant interaction effect independent, if there were multiple significant interactions? | When testing multiple hypotheses in a single study, the analyses might yield more than one apparently significant interaction. These significant interactions might, however, be associated with each other, and thus explained by a common factor. |
| Was the direction of the subgroup effect correctly pre-specified? | A subgroup effect consistent with the pre-specified direction will increase the credibility of a subgroup analysis. Failure to specify the direction or even getting the wrong direction weakens the case for a real underlying subgroup effect |
| Was the subgroup effect consistent with evidence from previous studies? | A hypothesis concerning differential response in a subgroup of patients may be generated by examination of data from a single study. The interaction becomes far more credible if it is also found in other similar studies. The extent to which a comprehensive scientific overview of the relevant literature finds an interaction to be consistently present is probably the best single index as to whether it should be believed. In other words, the replication of an interaction in independent, unbiased studies provides strong support for its believability. |
| Was the subgroup effect consistent across related outcomes? | The subgroup effect is more likely to be real if its effect manifest across all closely related outcomes. Studies must determine whether the subgroup effect existed among related outcomes. |
| Was there indirect evidence to support the apparent subgroups effect (biological rationale, laboratory tests, animal studies)? | We are generally more ready to believe a hypothesised interaction if indirect evidence makes the interaction more plausible. That is, to the extent that a hypothesis is consistent with our current understanding of the biologic mechanisms of disease, we are more likely to believe it. Such understanding comes from three types of indirect evidence: (i) from studies of different populations (including animal studies); (ii) from observations of interactions for similar interventions; and (iii) from results of studies of other related outcomes. |
List of included studies evaluating public health interventions’ impact by SES.
| Mexico | Taxation of foods and sugar sweetened beverages | Purchases of packaged foods | Education level and ownership of household assets | Weak | 7 | |
| USA | Health education; community based education | % change of the % of people who consume five portions of fruit and vegetables per day | Education level | Moderate | 1 | |
| USA | Health education; Tailored feedback and self-help dietary intervention | Mean fruit and vegetable intake score | Education level | Strong | 4 | |
| Mexico | Taxation of sugar sweetened beverages | Purchases of sugar sweetened beverages | Education level and ownership of household assets | Weak | 4 | |
| USA | Dietary counselling intervention | Change in serum cholesterol (mg/dl) | Household income | Moderate | 5 | |
| UK | Health education: Cooking fair with cooking lessons accompanying personalised dietary goal settings | % change in mean food energy from fat | Area level index of multiple deprivation | Moderate | 6 | |
| USA | Health education: healthy nutrition program aimed at adult women | Change in mean daily servings consumed of fruit and vegetables | Education level | Moderate | 3 | |
| USA | Dietary counselling intervention | % change in fruit and vegetables consumed | Education level | Moderate | 5 | |
| Norway | Dietary counselling intervention | % change in cholesterol | Social class | Moderate | 3 | |
| England | School based intervention | Change in portions of fruit and vegetables consumed | Area level index of multiple deprivation | Moderate | 5 | |
| UK | Water fluoridation | Tooth decay | Area level index of multiple deprivation | Moderate | 6 | |
| France | Health education: healthy nutrition program aimed at children | Change in % of children overweight | Area level index of multiple deprivation | Strong | 3 | |
| UK | Health education: Healthy nutrition program aimed at children | % change in vegetables observed consumed | Free school meal entitlement | Weak | 5 | |
| UK | Privatisation on employees of regional water authority | Employer job satisfaction and wellbeing | Occupation | Weak | 5 | |
| Germany | Health education: healthy nutrition programme aimed at children | Change in % prevalence of overweight | Parental education level | Weak | 8 | |
| School-based physical activity programmes | 10–11 year old school children | Physical activity levels | Household income and parental education level | Moderate | 7 | |
| USA | Health education: healthy nutrition programme aimed at children | Portion of fruit and vegetables consumed | Household income | Moderate | 3 | |
| Australia | Health education: healthy nutrition programme aimed at adults | Change in fat density consumed (g/4200 kcal) | Occupational prestige | Moderate | 6 | |
| USA | Work based intervention | Change in geometric mean grams of fibre per 1000 kcals | Occupation | Moderate | 9 | |
| Denmark | Dietary counselling intervention | Change in amount of fruit eaten by men (g/week) | Education level | Moderate | 5 | |
| Holland | Area based intervention | Difference in mean energy intake between intervention and control (MJ/d) | Education level | Strong | 8 |
Summary of intervention details and effects on health inequalities taken from McGill et al. (2015).
Fig. 1Frequency distribution of credibility of subgroup analysis scores amongst the included studies.
Number and percentage of studies scoring positively on each of the credibility of subgroup analysis criteria.
| Credibility of subgroup analysis criterion | Number (%) of studies |
|---|---|
| Is the subgroup variable a characteristic measured at baseline? | 21/21 (100%) |
| Was the subgroup variable a stratification factor at randomisation? | 4/17 (19%) |
| Was the hypothesis specified a priori? | 5/21 (24%) |
| Was the subgroup analysis one of a small number of subgroup analyses tested (≤5)? | 10/21 (48%) |
| Was the test of interaction significant (interaction | 17/21 (81%) |
| Was the significant interaction effect independent, if there were multiple significant interactions? | 5/18 (24%) |
| Was the direction of the subgroup effect correctly pre-specified? | 4/21 (19%) |
| Was the subgroup effect consistent with evidence from previous studies? | 19/21 (90%) |
| Was the subgroup effect consistent across related outcomes? | 10/21 (48%) |
| Was there indirect evidence to support the apparent subgroups effect (biological rationale, laboratory tests, animal studies)? | 13/21 (62%) |
Note: A lower denominator reflects the fact that these criteria were not applicable to all of the studies evaluated, either because the study was not an RCT or because the study did not report a significant interaction.