Health Improvement Review Evidence Sub Group & Economic Evidence Sub Group Health Improvement Review Assessment of No Smoking Day The following report includes the assessments of the evidence base produced by the Evidence subgroup (section 1- Evidence of Effectiveness) and the Economic Evidence sub-group (section 2 – Evidence of Cost effectiveness). Section 1: Evidence of Effectiveness 1. Introduction A core component of the Health Improvement Review (HIR) has been the assessment of the evidence-base for initiatives included in the HIR. This report describes the methodology for, and findings of, the assessment of the No Smoking Day programme. 2. Methodology Assessment of the initiative employed a dual approach: Assessment of the potential effectiveness of the initiative by review of research on the effectiveness of similar initiatives or of component interventions (some initiatives involve more than one intervention). Assessment of the actual effectiveness or impact of the initiative by review of any available evaluation reports for the initiative in Wales. 2.1 Review of potential effectiveness The methodology adopted for this review followed systematic review principles of transparency, a priori setting of the research question, search strategy, inclusion/exclusion criteria, critical appraisal and standardised data extraction. 2.1.1 A ‘question’ was developed for each initiative following the PICO format1. For No Smoking Day, the question was: Is 'No smoking Day' effective in promoting quit attempts on the day and in sustaining non-smoking? 2.1.2 Due to the time constraints of the Health Improvement Review, a ‘best available evidence’ approach was taken for the reviews of research on potential effectiveness of initiatives. Key words and search terms were derived from the question and a pragmatic search strategy designed using specified health databases and search-engines. For initiatives where recent high quality secondary analyses of the primary literature were found, searches were narrower and terminated at an earlier stage. Searches for questions that yielded little high quality data initially were broadened by date or by search terms in an attempt to capture related work. The time-constraints did not enable handsearching or contacts with experts in the field (external to Public Health Wales) to search for missed or unpublished data, however, an iterative process of 1 Population, Intervention, Comparator, Outcomes Public Health Wales Observatory Health Improvement Review Evidence Sub Group & Economic Evidence Sub Group related article searches were run on key papers for some questions to try and capture information that the initial search strategy had not identified. All reasonable efforts were made to locate the most relevant and highest quality evidence in the short-time frame allocated. The search terms used for No Smoking Day Search strategy “no smoking day” Databases searched TRIP Database NHS Evidence Campbell Collaboration EPPI Centre PubMEd Google Scholar Health Evidence Canada WHO 2.1.3 Retrieved articles were recorded in the ‘Evidence Mapping Table’ for the initiative (Table 1) and were screened for inclusion by two reviewers independently (disagreements resolved by discussion), on the basis of direct relevance to the initiative or component interventions and type of article, thus single studies were not included if higher level evidence was available: Primary group of sources: NICE guidance, Single systematic reviews from Cochrane, Campbell Libraries, the EPPI-Centre Secondary group (include if no primary group evidence items available): RCT or evaluation of robust design looking at appropriate outcomes Other study designs to be included if no primary or secondary sources are available, the quality of these to be judged separately/recorded on a case-by-case basis. 2.1.4 Information was extracted from each included article into a standardised template – the Evidence Mapping Table, for each initiative. 2.1.5 Each included article was assessed in terms of ‘reliability’, strength and direction, using the following ‘Evidence Grading Scheme’: ++ 2 Directly relevant evidence that the intervention evaluated is beneficial/ useful/ effective - the evidence comes from a reliable source2 and is guidance based on RCTs, SRs or robust evaluations of appropriate outcomes or is a well conducted systematic review. See section 2.1.2 Initiative Evidence Assessment Report NSD Final Page 2 Public Health Wales Observatory + +/0 -not - Ql Health Improvement Review Evidence Sub Group & Economic Evidence Sub Group Directly relevant evidence that the intervention evaluated is beneficial/ useful/effective -the evidence comes from a reliable source and is a robust/ large RCT or robust evaluation of appropriate outcomes. Conflicting evidence (from reliable sources) about the usefulness/efficacy of the intervention being evaluated. Directly relevant evidence on effectiveness of an intervention the same as, or similar to, the initiative, of acceptable reliability, is lacking. Directly relevant evidence that the intervention being evaluated is beneficial/useful or is ineffective - the evidence comes from a reliable source and is guidance based on RCTs, SRs or robust evaluations of appropriate outcomes or is a well conducted systematic review. Directly relevant evidence that the intervention evaluated is not beneficial/useful or is ineffective -the evidence comes from a reliable source and is a robust/large RCT or robust evaluation of appropriate outcomes. Well conducted studies using robust qualitative research methods which cast light on how/why intervention might be effective/ineffective or have important implications for interpretation of findings or other included studies. The ‘evidence grades’ for each included article were recorded in the Evidence Mapping Table for the initiative (Table 1). 2.1.6 A subjective judgment of the overall balance of evidence grades given to included articles was then made by one reviewer, to give a ‘Summary Evidence Grade’ for the Initiative: ++ + +/0 -- There is consistent, strong relevant evidence from reliable sources that the intervention/approach employed in the initiative has the potential to be effective. There is some relevant evidence from reliable sources that the intervention/approach employed in the initiative has the potential to be effective. Relevant evidence (from reliable sources) about the likely effectiveness of the intervention/approach employed in the initiative is conflicting. Directly relevant evidence (from reliable sources) about the likely effectiveness of the intervention/approach employed in the initiative is lacking. There is consistent, strong relevant evidence from reliable sources that the intervention/approach employed in the initiative has the potential to be ineffective. Initiative Evidence Assessment Report NSD Final Page 3 Public Health Wales Observatory - Health Improvement Review Evidence Sub Group & Economic Evidence Sub Group There is some relevant evidence from reliable sources that the intervention/approach employed in the initiative has the potential to be ineffective. Checks were made for consistency of application of these ‘Summary Evidence Grades’ through comparison and discussion amongst the reviewer team. 2.2) Assessment of initiative An ‘Initiative Assessment Log’ was then completed (Table 2). Information from any evaluation or other reports about the initiative in Wales was considered for relevance at this stage and pertinent information summarised into the log along with the Summary Evidence Grade and other information. A final ‘Initiative Grade’ was then applied by one reviewer using set criteria (see Annex 1). This therefore takes into account both the evidence of potential effectiveness and evidence of actual effectiveness in Wales, where available. This Initiative Grade’ will feed directly into the Programme Budgeting and Marginal Analysis which forms the decision-making framework for the Health Improvement Review. Initiative grades were checked for consistency by comparison and discussion amongst the review team. Initiative Evidence Assessment Report NSD Final Page 4 Health Improvement Review Evidence Sub Group & Economic Evidence Sub Group Public Health Wales Observatory 3. Findings of the assessment Table 1: Evidence Mapping Table for No Smoking Day Study Study Outcome Main findings Details design measures 1. Kotz D, Stapleton JA, Owen L, West R. 2011 Interventio n Reviewed “No smoking day” Target group Working Age Adults Cross sectional surveys Comparison of reported quit attempts in the month following NSD for three consecutive years with adjacent months using repeated national surveys of quit attempts. The number of additional smokers who quit permanently in response to NSD was estimated from the survey results. The incremental costeffectiveness ratio (ICER) was calculated by combining this estimate with established estimates of life years Initiative Evidence Assessment Report NSD Final NSD emerges as an extremely cost-effective public health intervention. Results The rate of quit attempts was 2.8 percentage points higher in the months following NSD (120/1309) compared with the adjacent months (170/2672; 95% CI 0.99% to 4.62%), leading to an estimated additional 0.07% of the 8.5 million smokers in England quitting permanently in response to NSD. The cost of NSD per smoker was £ 0.088. The discounted life years gained per smoker in the modal age group 35-44 years was 0.00107, resulting in an ICER of £ 82.24 (95% CI 49.7 to 231.6). ICER estimates for other age groups were Evidence Grading Evidence Grading + Include? Reason for exclusion Include Page 5 Health Improvement Review Evidence Sub Group & Economic Evidence Sub Group Public Health Wales Observatory Study Details Study design Outcome measures Main findings gained and the known costs of NSD. 2. Flack S, Taylor M & Trueman P. 2007 Interventio n Reviewed “No smoking day” A cohort simulation model of a range of interventions for NICE – using data from Owen and Youdan 2006 (below) Quit rate at three months If background quit rate 0%, NSD highly cost effective, if not estimated an additional 25 quitters needed to to cost effective Self reported awareness and smoking Data suggests that after 22 years No Smoking Initiative Evidence Assessment Report NSD Final Evidence Grading Include? Reason for exclusion similar. Target group – Whole population 3. Owen and Retrospectiv Youdan, 2006 e cross sectional Results The cost of the campaign was approximately £500,000. ‘No Smoking Day’ is highly costeffective. However, if No Smoking Day were to have simply brought forward the background quits for the following 9 to 12 months (and had not resulted in any “new” quitters), then it would not have been costeffective. The current analysis indicates No Smoking Day would need to gain 25 new quitters in order to be cost-effective. Annual tracking survey shows reduction from 1986 (89%) to 2004 Evidence Include Grading +/More recent studies provide evidence of increased quitters compared to background Evidence Grading + Include Page 6 Health Improvement Review Evidence Sub Group & Economic Evidence Sub Group Public Health Wales Observatory Study Details Interventio n – No Smoking Day Target Group – Working Age Adults 4. No Smoking Day Annual Report 2010 Study design Outcome measures Main findings Results surveys and information collated on website activity, media coverage and calls to smoking helplines in 2005 behaviour 1wk and 3 month post NSD, volume of contacts (78%) in awareness by smokers, 15% of those who were aware reported attempted quit, 1.2% sustained at 3 months. Suggests younger smokers more likely to participate 0.7% of all smokers were still not smoking (85,000 quitters) and 1.6% (160,000) smoking less. Evaluation research was undertaken after the campaign by GfK NOP. The results are based on interviews with 4,008 Awareness of NSD; participation in NSD e.g. making a quit attempt Day continues to be successful in reaching smokers. With a budget insufficient to pay for advertising this public awareness campaign supported by local activities appears to be effective at helping smokers to stop. NSD continues to have relatively high participation and awareness Initiative Evidence Assessment Report NSD Final 48% of smokers were aware of the day (41% in Wales) up to 70% in Northern Ireland, of these 18% men and 17% women partipcated in the day. The participation rate is higher among young smokers aged 16 – 24 (28%). Evidence Grading Include? Reason for exclusion Evidence Grading – evaluation Include Page 7 Health Improvement Review Evidence Sub Group & Economic Evidence Sub Group Public Health Wales Observatory Study Details Study design Outcome measures Main findings Results Evidence Grading Include? Reason for exclusion adults aged 16 and over. These interviews were conducted in two omnibus sessions during the two weeks immediately following No Smoking Day (11-23 March 2010). Respondents were selected by quotas of age, sex and socioeconomic classification. Initiative Evidence Assessment Report NSD Final Page 8 Public Health Wales Observatory Health Improvement Review Evidence Sub Group & Economic Evidence Sub Group References 1) Kotz D, Stapleton JA, Owen L, West R. How cost-effective is 'No Smoking Day'? Tob Control. 2011 Jul;20(4):302-4. Epub 2010 May 14. PubMed http://www.ncbi.nlm.nih.gov/pubmed/20472574 2) Flack S, Taylor M & Trueman P. Cost-Effectiveness of Interventions for Smoking Cessation. Supplementary Report to NICE, November 2007. http://www.nice.org.uk/nicemedia/live/11925/43883/43883.pdf 3) Owen, L and Youdan B. 22 years on: the impact and relevance of the UK No Smoking Day. Tobacco Control. 2006; 15 19 – 25 4) No Smoking Day Annual Review 2010. No Smoking Day. http://www.nosmokingday.org.uk/downloads/annual_report_nsd2010.pdf Initiative Evidence Assessment Report NSD Final Page 9 Health Improvement Review Evidence Sub Group & Economic Evidence Sub Group Public Health Wales Observatory Table 2: INITIATIVE ASSESSMENT LOG Initiative/Intervention Priority Area: Intervention Summary No Smoking Day Tobacco Control Annual event targeted at smokers to encourage a quit attempt, national co-ordination on a UK/Wales basis with supported local action Targeted Population Working Age Adults Individual behaviour change - indirect JB Level of Intervention Life-course Outcome Category ATTRACT/Initiative Reviewer Evidence Base Summary Evidence Grade + There is some relevant evidence from reliable sources that the intervention/approach employed in the initiative has the potential to be effective (see evidence table) Implementation/ Yes evaluation? Initiative is a No pilot? Population impact Medium – evidence of population level effect among smokers Programme There is good evidence to support the effectiveness of No Smoking Day as a component of an integrated cessation strategy. There is evidence of particular impact among younger smokers. Grade: G2 Initiative Evidence Assessment Report NSD Final Page 10 Public Health Wales Observatory Health Improvement Review Evidence Sub Group & Economic Evidence Sub Group 4. Limitations of this review There are a number of limitations to the approach taken for this review which have arisen due to the time constraints imposed and which should be taken into account when interpreting the findings: The review has used higher levels of evidence such as NICE guidance and systematic reviews from specific sources rather than undertaking an extensive review of primary research. Other sources and individual studies have only been included where higher level sources are lacking. It is possible that relevant, more recent primary research will not have been included in the guidance or systematic reviews we have consulted. There may be no published research evidence for innovative technologies and approaches. We have only considered ‘grey’ literature ie reports on such initiatives elsewhere, when these have been supplied to us by subject experts and those involved with implementation of the initiatives in Wales, we have not systematically searched for grey literature. NICE guidance has been prioritised, in that if an intervention is recommended for implementation in the UK, this has influenced the ‘initiative grade’ awarded. It should be noted however, that not all NICE recommendations are underpinned by directly relevant robust research evidence. We have highlighted this where it has been found to be the case. Initiative Evidence Assessment Report NSD Final Page 11 Health Improvement Review Evidence Sub Group & Economic Evidence Sub Group Public Health Wales Observatory Annex 1: Scheme for producing ‘Initiative Grade’ Initiative GI G II AI A II A III RI R II R III R IV Priority area? Yes Yes Yes Yes Yes Yes Yes Yes N Summary Evidence Grade2 ++ + ++ + +/- +/- -or- - -or- - N.A or or 0 0 Yes No Yes No N.A. Grade1: Evaluation3? Yes Yes No No 1. G=Green, A=Amber, R=Red N.A. = Not applicable 2. Overall grade for evidence-base for initiative 3. If there is no local (Welsh) evaluation or if the evaluation does not provide information about achievement of appropriate outcomes (effectiveness), then record ‘No’. Section 2: Evidence of Cost-effectiveness 1. Grading of Evidence Criteria Evidence search had a 10 year range 2012-2002 in order to find as much evidence as possible as the range stated for other sub-groups was considered too narrow to find sufficient economic evidence. Databases such as NICE, Pub-Med and the Centre for Reviews and Dissemination (CRD) Database - which is an economic evidence specific database. These databases are searched using key terms from each of the 43 Priority area programmes. Alongside these databases other evidence sub-groups have been highlighting any economic evidence found in their searches and forwarding our sub-group the reference for us to appraise. Abstracts were appraised in the electronic search with the reviewer and for articles deemed relevant the full article was sourced and then appraised as follows; Evidence was defined as; 1. Directly relevant i.e. an economic evaluation of a specific intervention delivered through the programme/initiative stated in the list of included programmes Initiative Evidence Assessment Report NSD Final Page 12 Public Health Wales Observatory Health Improvement Review Evidence Sub Group & Economic Evidence Sub Group 2. Indirectly relevant (where directly relevant evidence is unavailable) i.e. evaluation of related intervention similar to the one delivered through the programme/initiative or as part of the intended aims of the programme/initiative stated in the list of included programmes by either method of delivery (school-based smoking cessation) or target population (pregnant women). The Drummond et al. (2005) checklist for a sound economic evaluation was used to appraise evidence found in the electronic searches (Annex 2). Based upon the appraisal strategy above a subjective judgement of the overall balance of economic evidence was made by the economic evidence sub-group using a traffic light system of grading (Annex 3). Initiative Evidence Assessment Report NSD Final Page 13 Public Health Wales Observatory Health Improvement Review Evidence Sub Group & Economic Evidence Sub Group 2. Evidence of cost-effectiveness summary No Smoking Day Green II – Small number of good quality economic evaluations showing cost-effectiveness/cost-savings/ cost-benefits as appraised by Drummond et al’s 2005 Checklist for a sound economic evaluation In the only initiative specific economic evaluation found (Kotz et al. 2011) No Smoking Day was found to be cost-effective for the modal group of adults aged between 35-44 years group. Using survey data from 3981 respondents of a National No Smoking Day (NSD) Survey conducted in England. 1309 adults responded in the month following NSD and 2672 adults responded in the two adjacent months. The annual cost of NSD was £750, 000 (£0.088 per smoker). The quit attempt rate was 9.2% for those completing the survey in the month following NSD compared to 6.4% for the two adjacent months (incremental difference 2.8%). The measure of benefit in the study were discounted life years gained (DLYG) per smoker that can be attributed to NSD. Results were categorised by age group. Adults < 35 years of age showed a gain of 1.10 discounted life years (DLY), adults between 35-44 years of age showed a gain of 1.53 DLY, adults between 45-54 years of age showed a gain of 1.65 DLY and adults between 55-64 years of age showed a gain of 1.29 DLY. The cost per DLYG was £82.24 for the modal group of adults aged between 35-44 years age group. The cost per DLYG was £114.29 for the < 35 age group. The cost per DLYG was £76.19 for the 45-54 age group and the cost per DLYG was £97.45 for the 55-64 age group. Reference: Kotz, D., Stapleton, J.A., Owen, L., & West, R. (2010). How cost-effective is ‘No Smoking Day’? Tobacco Control, doi:10.1136/tc.2009.034397 Initiative Evidence Assessment Report NSD Final Page 14 Public Health Wales Observatory Annex 2: Health Improvement Review Evidence Sub Group & Economic Evidence Sub Group Drummond Checklist for sound economic evaluation Drummond, M.F., Sculpher, M.J., Torrance, G.W., O’Brien, B.J., & Stoddart, G.L. (2005). Methods for the economic evaluation of health care programmes (3rd Ed.). Oxford University Press: Oxford, U.K). 1. Was a well-defined question posed in answerable form? 1.1. Did the study examine both costs and effects of the service(s) or programme(s)? 1.2. Did the study involve a comparison of alternatives? 1.3. Was a viewpoint for the analysis stated and was the study placed in any particular decision-making context? 2. Was a comprehensive description of the competing alternatives given (i.e. can you tell who did what to whom, where, and how often)? 2.1. Were there any important alternatives omitted? 2.2. Was (should) a do-nothing alternative be considered? 3. Was the effectiveness of the programme or services established? 3.1. Was this done through a randomised, controlled clinical trial? If so, did the trial protocol reflect what would happen in regular practice? 3.2. Was effectiveness established through an overview of clinical studies? 3.3. Were observational data or assumptions used to establish effectiveness? If so, what are the potential biases in results? 4. Were all the important and relevant costs and consequences for each alternative identified? 4.1. Was the range wide enough for the research question at hand? 4.2. Did it cover all relevant viewpoints? (Possible viewpoints include the community or social viewpoint, and those of patients and third-party payers. Other viewpoints may also be relevant depending upon the particular analysis.) 4.3. Were the capital costs, as well as operating costs, included? 5. Were costs and consequences measured accurately in appropriate physical units (e.g. hours of nursing time, number of physician visits, lost work-days, gained life years)? 5.1. Were any of the identified items omitted from measurement? If so, does this mean that they carried no weight in the subsequent analysis? 5.2. Were there any special circumstances (e.g., joint use of resources) that made measurement difficult? Were these circumstances handled appropriately? 6. Were the cost and consequences valued credibly? 6.1. Were the sources of all values clearly identified? (Possible sources include market values, patient or client preferences and views, policy-makers’ views and health professionals’ judgements) 6.2. Were market values employed for changes involving resources gained or depleted? 6.3. Where market values were absent (e.g. volunteer labour), or market Initiative Evidence Assessment Report NSD Final Page 15 Public Health Wales Observatory Health Improvement Review Evidence Sub Group & Economic Evidence Sub Group values did not reflect actual values (such as clinic space donated at a reduced rate), were adjustments made to approximate market values? 6.4. Was the valuation of consequences appropriate for the question posed (i.e. has the appropriate type or types of analysis – cost-effectiveness, costbenefit, cost-utility – been selected)? 7. Were costs and consequences adjusted for differential timing? 7.1. Were costs and consequences that occur in the future ‘discounted’ to their present values? 7.2. Was there any justification given for the discount rate used? 8. Was an incremental analysis of costs and consequences of alternatives performed? 8.1. Were the additional (incremental) costs generated by one alternative over another compared to the additional effects, benefits, or utilities generated? 9. Was allowance made for uncertainty in the estimates of costs and consequences? 9.1. If data on costs and consequences were stochastic (randomly determined sequence of observations), were appropriate statistical analyses performed? 9.2. If a sensitivity analysis was employed, was justification provided for the range of values (or for key study parameters)? 9.3. Were the study results sensitive to changes in the values (within the assumed range for sensitivity analysis, or within the confidence interval around the ratio of costs to consequences)? 10. Did the presentation and discussion of study results include all issues of concern to users? 10.1. Were the conclusions of the analysis based on some overall index or ratio of costs to consequences (e.g. cost-effectiveness ratio)? If so, was the index interpreted intelligently or in a mechanistic fashion? 10.2. Were the results compared with those of others who have investigated the same question? If so, were allowances made for potential differences in study methodology? 10.3. Did the study discuss the generalisability of the results to other settings and patient/client groups? 10.4. Did the study allude to, or take account of, other important factors in the choice or decision under consideration (e.g. distribution of costs and consequences, or relevant ethical issues)? 10.5. Did the study discuss issues of implementation, such as the feasibility of adopting the ‘preferred’ programme given existing financial or other constraints, and whether any freed resources could be redeployed to other worthwhile programmes? Initiative Evidence Assessment Report NSD Final Page 16 Health Improvement Review Evidence Sub Group & Economic Evidence Sub Group Public Health Wales Observatory Annex 3 Evidence of Cost-effectiveness Grading Based upon the appraisal strategy above a subjective judgement of the overall balance of economic evidence was made by the economic evidence sub-group and the following traffic light system of grading was used. Green I Large frequency of good quality economic evaluation s showing costeffectivene ss/ costsavings/ costbenefits as appraised by Drummond et al’s 2005 Checklist for a sound economic evaluation Green II Small frequency of good quality economic evaluation s showing costeffectivene ss/ costsavings/ costbenefits as appraised by Drummond et al’s 2005 Checklist for a sound economic evaluation Amber I Fair quality economic evaluation s showing costeffectivene ss/ costsavings/ costbenefits as appraised by Drummond et al’s 2005 Checklist for a sound economic evaluation Initiative Evidence Assessment Report NSD Final Amber II Fair quality evidence however, showing mixed evidence of costeffectivene ss/ costsavings/ costbenefits as appraised by Drummond et al’s 2005 Checklist for a sound economic evaluation Red I Poor quality evidence showing interventio n was not costeffectivene ss/ costsavings/ costbenefits as appraised by Drummond et al’s Checklist for a sound economic evaluation Red II No eviden ce availa ble Page 17
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