Normalization and informed decision making in public health programs: A case study of HPV vaccination in Canada. Brenda Wilson Tanya Navaneelan

Transcription

1 Normalization and informed decision making in public health programs: A case study of HPV vaccination in Canada Brenda Wilson Tanya Navaneelan

2 Acknowledgements Julian Little, Beth Potter, Department of Epidemiology & Community Medicine, University of Ottawa Ryan Melnychuck, Office of Public Health Practice, Public Health Agency of Canada Silvia Visentin, CIHR Emerging Team in Genomics in Screening, University of Ottawa Supported by Canadian Institutes of Health Research award # ICG The views expressed are those of the authors only

3 Background In public health, where is the balance between actively promoting acceptance and actively supporting individualized decision making? What are the differences and similarities between public health interventions and individual health care interventions?

4 Personal health care interventions Preference sensitive decision making : e.g. hormone replacement therapy, prenatal testing Goal is a good decision for the individual Autonomy is a primary concern Uptake rates are irrelevant One person s choice makes no difference to other people s health Use of decision aids, importance of balanced information, importance of individual values and attitudes

5 Population oriented health interventions All or nothing implementation: e.g. fluoridation, quarantine laws, smoking free cities Goal is benefit measured at population level Universal coverage is primary concern Autonomy is irrelevant One person s choice (if available) may affect other people s health Use of legislation, free provision, persuasive information, political processes replace individual value assessments

6 Spectrum? Individually oriented interventions informed decision making preference sensitive goal is good decision for individual risks and benefits individually judged individual rights model Population oriented interventions normalization pure public health goal is high population coverage low risk, high benefit utilitarian model HRT water supply fluoridation

7 In the grey area? Individually oriented interventions informed decision making preference sensitive goal is good decision for individual risks and benefits individually judged individual rights model Population oriented interventions normalization pure public health goal is high population coverage low risk, high benefit utilitarian model

8 In the grey area? Health interventions that are population oriented but delivered to individuals e.g. immunization, screening

9 Why does this matter? Guides practical implementation of programs Defines most important measures of performance Trust, ethics, accountability

10 Norms shared expectations or social rules of behaviour that connote what is considered culturally desirable and appropriate often implicit and tacitly developed essentially prescriptive, but usually lack formal or explicit status constructed, understood and disseminated through social interaction and communication

11 Normalization of new health interventions Tendency towards automatic adoption of a new health intervention Integration may occur irrespective of formal evidence Promoting a new technology as standard of care fosters expectations of availability and acceptance of its benefits by providers and users. Effective technologies may promote benefit (e.g. early days of antibiotics) Unproven technologies may promote unrealistic demand, poor use of resources, harms, possibly loss of trust

12 Convergence of normalizing influences Approval of a new drug by a regulatory authority Provision free at the point of use Laws, legislation Policy guidance, information distribution Professional and mass media Mandated use of the intervention or technology

13 Aim of project To use HPV vaccination in Canada as a case study to explore normalization and informed decision making in public health programs in Canada. Specifically, to examine the consonance or discordance between policy intent and program implementation.

14 Five separate enquiries, three domains Science 1. What was the scientific evidence on HPV vaccination? 2. How was this interpreted by the scientific/medical community? Policy 3. How was health policy about HPV vaccination created and implemented? Public 4. What did public health education materials say? 5. What did the media say?

15 Q1: What was the scientific evidence? Review of systematic reviews Explicit search strategy Medline, Embase, CDSR (to week 38, 2010) Eligibility (inclusion criteria for source reviews) Participants: female participants, any age Design: RCTs only Intervention: HPV vaccine designed to target 1 oncogenic HPV strain, used for prophylaxis Controls: placebo or no intervention Outcomes: incident HPV infection, persistent HPV infection, low grade or high grade cervical lesions, adverse events, death Data abstraction type of vaccines reviewed (monovalent, bivalent, quadrivalent) reported pooled effect estimates by individual outcome Quality assessment AMSTAR

16 Summary of findings (n=3 reviews, 9 trials) Study participants mainly 5 25 years, white and healthy Two major outcomes (cervical cancer incidence and mortality) not evaluated Evidence generally consistent with protective effect against persistent HPV infection and cervical intraepithelial neoplasia No evidence of significant risk of adverse effects No data on long term immunity, no distinction between regressing and progressing infections and lesions Large number lost to follow up or excluded from the analyses Reviews noted possible implications of vaccinating against only two strains of the virus and need for cancer screening to continue after vaccination

17 Q2: How was this interpreted? Narrative systematic review of editorials Explicit search strategy Scopus database, Medline, Jan 2005 Dec 2006 Eligibility Journal type: medical or medical/biological science journal Article type: editorial, commentary, letter Article focus: HPV vaccination major topic Article content: epidemiology, public health, clinical, policy Analysis general tone regarding HPV vaccination (negative, positive, mixed, neutral) specific content items dominant message (negative, positive, neutral) regarding HPV vaccination Reliability Second reader reviewed random sample

18 General tone Tone and content (n=52) Clearly positive (26), clearly negative (11), mixed (11), neutral (4) Discrete content topics 38 topics, very diverse; most common: concerns about cultural acceptability (24) parental concern about risk compensation (19) need for greater education about HPV (17) high cost of the vaccine (16) single gender vaccination cannot achieve herd immunity (15) high efficacy in preventing infection and low grade lesions (14) social inequalities in cervical cancer and HPV infection (14)

19 Dominant messages Negative/concerns 1. Downsides in implementation cultural acceptability, promoting risky sexual behaviour, high cost, difficulty with achieving herd immunity 2. Scientific evidence inadequate for policy decisions 3. Vaccine program might replicate existing social disparities in HPV infection and cervical cancer 4. Public trust profit motive, politicization of the issue, lobbying and marketing strategies Positive 6. Potential for vaccine in the developing world, high risk populations 7. Vaccine could be cost saving in the long run Neutral 8. Greater education about HPV is needed 9. Difficulties in communicating about vaccines need to be addressed

20 Overall: cautious optimism but hold off Scientific and medical discourse extremely varied Not a black and white issue: great potential recognized while important research and policy questions identified A few authors had major problems with the idea of widespread vaccination Most authors indicated need to wait for further evidence before proceeding

21 Q3: How was policy created and implemented? Document analysis Wide searching: Peer reviewed journal databases Medline, EMBASE, PubMed Public Health Agency of Canada Website and publication database Health Canada Website and publication database Public Works and Government Services Canada Website and publication database National Advisory Committee on Immunization (NACI) Statements and position papers Canadian Immunization Committee (CIC) Statements and position papers Hansard transcripts of the Parliament of Canada House of Commons debates Hansard transcripts of provincial parliaments General internet search for unpublished documents (e.g. conference presentations)

22 Health Canada Regulatory approval Authorizes for use in Canada National Advisory Committee on Immunization (NACI) Canadian Immunization Committee (CIC) Scientific evaluation Feasibility, cost-effectiveness evaluation using Erikson-de Wals framework Recommendations published in CCDR, Canadian Immunization Guide Recommendations to provinces/territories for funding, program implementation Provinces, territories Review CIC recommendations Make funding and implementation decisions, develop and implement program All within context of National Immunization Strategy goal is to harmonize provincial/territorial programs

23 Gardasil is submitted for regulatory approval Health Canada approves Gardasil for use in Canada NACI issues recommendations CIC publishes guidance Provinces/territories implement vaccination programs

24 Canadian HPV Research Priorities Workshop identifies many research questions Public Health Network identifies HPV vaccine as a priority in program planning Gardasil is submitted for regulatory approval NACI/CIC working group is established Health Canada approves Gardasil for use in Canada NACI issues recommendations Federal government announces $300m HPV Immunization Trust PHAC publishes literature review Four provinces implement vaccination programs CIC publishes guidance Six remaining provinces implement vaccination programs

25 1 Manufacturer s recommendation ( standard ): three doses at 0, 2, 6 months

26 CIC recommendations: goals for HPV immunization programs 1. Reduce by 60% the CIN 2/3 caused by HPV 16/18 in Canada within 20 years of introduction of an HPV vaccination program 2. Reduce by 60% the incidence of cervical cancers (and other HPV related cancers) caused by HPV 16/18 in Canada within 30 years of introduction of an HPV vaccination program 3. Reduce by 60% mortality due to cervical cancer caused by HPV 16/18 in Canada within 35 years of introduction of an HPV vaccination program. N.B. Feasibility of recommendations based on a number of assumptions, including (a) that vaccine immunity would be lifelong vaccine, (b) efficacy is at least 95%, and (c) coverage of 85% for 11 year old girls, 80% for 14 year old girls and 75% for 17 year old girls.

27 Q4: What did public educational materials say? Content analysis of online materials Systematic search of online education materials Provincial websites, PHAC, Health Canada Eligibility Online material English language Aimed at general public 50% content on HPV Analysis Content 24 items identified a priori as representing full information Readability Flesch Kincaid index, Gunning FOG index, SMOG index [Suitability Suitability Assessment of Materials (SAM) tool] Themes content analysis Validation Second reviewer

28 Eligible: 17 documents, by 12 agencies Content coverage

29 High reading age Readability (grade level) Range Average 10.7 Main reasons: complicated terminology

30 Summary of main themes Balance 1/17 well balanced overall, encouraged reflection on personal beliefs and feelings, and included a decision aid 50% seemed framed to persuade, e.g. Be informed: have your daughter immunized against HPV Many individual normalizing messages: How girls can make their parents comfortable with getting them immunized Parents should encourage their daughter to get the HPV vaccine Lists of Why should I get vaccinated Statements that the vaccine prevents cancer, is recommended Option of declining or delaying decision rarely presented (3/17); 2 warned of possible costs ($400 $600 for later vaccination)

31 Q5: What did the media say? Content analysis of print media Source four highest circulation English language newspapers (Globe and Mail, National Post, Toronto Star, Montreal Gazette) Article eligibility HPV vaccination the major focus News articles or editorial 100 words Published July 1, 2006 June 30, 2008 Analysis General tone [content ] Themes Validation Second reviewer, 10% sample

32 Publications over period of interest (n=82)

33 Tone (n=82) 42 mixed, 27 positive, 8 negative, 5 neutral Shift over time

34 Seven major themes 1. The HPV vaccine is a scientific breakthrough One of the most significant events of the last 100 years in the field of cancer control 2. This is an anti cancer vaccine Cervical cancer vaccine hailed 3. Good parents immunize their daughters I couldn't imagine who wouldn't want their daughter protected 4. HPV vaccination promotes women's health This vaccine is the best thing to happen to women's sexual health since the Pill 5. The vaccine exists, so we must use it Don't we have the responsibility to protect right away when the technology is there? 6. It can happen to you At the peak of their careers, with families 7. Concern about vaccination is a minority opinion [The Abby Lippman effect]

35 HPV vaccination on the spectrum? Individually oriented interventions informed decision making Population oriented interventions normalization Level of evidence on benefits Less than universal acceptability Low possibility of herd immunity

36 How was it implemented? Individually oriented interventions informed decision making Population oriented interventions normalization Delivered by personal provider Explicit consent Balanced information provision Performance judged by decision quality Delivered in school based program Mandated Persuasive information provision Performance judged by uptake

37 Process & implementation Anticipation of vaccine s arrival, and of its potential effect Priority before it was approved Two public health communities communicable disease and cancer control HPV vaccine is a cancer prevention vaccine, but seemed to be implemented within the Canadian vaccination machine Alternatives? Offer it as a preventive clinical service (like CRC screening) (informed decision making model) Offer within childhood immunization (to promote higher acceptability) (normalized model)

38 Conclusions HPV offers a useful case study of individual decisionmaking within a public health intervention Highlights the areas where policy intent and program implementation can become discordant, possibly even without politicization Not every public health intervention is like every other

39 Thank you