bmj open · heath, paul; st georges, university of london, paediatric infectious diseases research...

For peer review only

Factors influencing women’s attitudes towards a vaccine against Group B streptococcus and clinical trial participation

in pregnancy: A survey

Journal: BMJ Open

Manuscript ID bmjopen-2015-010790

Article Type: Research

Date Submitted by the Author: 08-Dec-2015

Complete List of Authors: McQuaid, Fiona; University of Oxford, Oxford Vaccine Group, NIHR Oxford Biomedical Research Centre, Department of Paediatrics, Jones, Christine; St George's, University of London, Paediatric Infectious

Diseases Research Group, Institute for Infection and Immunity, Stevens, Zoe; University of Oxford, Oxford Vaccine Group, NIHR Oxford Biomedical Research Centre, Department of Paediatrics, Plumb, Jane; Group B Strep support Hughes, Rhona; Royal Infirmary Edinburgh, Simpson Centre for Reproductive Health Bedford, Helen; UCL, Population, Policy and Practice Programme, UCL Institute of Child Health Voysey, Merryn; University of Oxford, Nuffield Department of Primary Care Health Sciences; University of Oxford, Oxford Vaccine Group, NIHR Oxford Biomedical Research Centre, Department of Paediatrics, Heath, Paul; St Georges, University of London, Paediatric Infectious

Diseases Research Group, Institute for Infection and Immunity, Snape, Matthew; University of Oxford, Oxford Vaccine Group, NIHR Oxford Biomedical Research Centre, Department of Paediatrics,

<b>Primary Subject Heading</b>:

Infectious diseases

Secondary Subject Heading: Obstetrics and gynaecology, Communication, Paediatrics

Keywords: Public health < INFECTIOUS DISEASES, NEONATOLOGY, Maternal medicine < OBSTETRICS, Paediatric infectious disease & immunisation < PAEDIATRICS, Clinical trials < THERAPEUTICS

For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml

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Title: 1

Factors influencing women’s attitudes towards a vaccine against Group B streptococcus and clinical 2

trial participation in pregnancy: A survey. 3

Corresponding author: 4

Fiona McQuaid, Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the 5

NIHR Oxford Biomedical Research Centre, Oxford, United Kingdom. [email protected], 6

Tel/Fax 01865857420 7

Co-authors: 8

Christine Jones, Paediatric Infectious Diseases Research Group, Institute for Infection and Immunity, 9

St Georges, University of London, London, United Kingdom 10

Zoe Stevens, Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR 11

Oxford Biomedical Research Centre, Oxford, United Kingdom 12

Jane Plumb, Group B Strep Support, Haywards Heath, West Sussex, United Kingdom 13

Rhona Hughes, Simpson Centre for Reproductive Health, Royal Infirmary, Edinburgh, United 14

Kingdom 15

Helen Bedford, Population, Policy and Practice Programme, UCL Institute of Child Health, London, 16

United Kingdom 17

Merryn Voysey M.Biostat Department of Primary Care Health Sciences, University of Oxford, 18

Oxford, United Kingdom 19

Paul T Heath, Paediatric Infectious Diseases Research Group & Vaccine Institute, Institute for 20

Infection and Immunity, St Georges, University of London, London, United Kingdom 21

Matthew D Snape, Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the 22

NIHR Oxford Biomedical Research Centre, Oxford, United Kingdom 23

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Funding 24

This survey was funded by a grant from Meningitis Now (formerly Meningitis UK), grant 25

number 6000. The funders had no role in the preparation of this manuscript. 26

Contributorship statement 27

FM wrote the article which was reviewed by all authors. Data analysis was performed by FM, 28

MDS and MV. All authors contributed to the design of the online survey. 29

Data sharing statement 30

Additional data is available on the Comres website http://comres.co.uk/poll/1028/gbs-31

vaccination-survey.htm or from the authors on request 32

Acknowledgments 33

We would like to thank the respondents to the online survey and E. Di Antonio and Holly Wicks 34

(ComRes) for assistance with survey preparation. 35

Competing interests 36

P.T. Heath serves as a consultant to Novartis Vaccines regarding Group B strep vaccine 37

development. He receives no personal funding for this. MDS has participated in advisory boards 38

and/or been an investigator on clinical trials of vaccines sponsored by vaccine manufacturers 39

including Novartis Vaccines, GlaxoSmithKline, Pfizer, Crucell and Sanofi Pasteur. Payment for 40

these services was made to the University of Oxford Department of Paediatrics. MDS has had 41

travel and accommodation expenses paid to attend conferences by Novartis Vaccines and 42

GlaxoSmithKline. MDS has received no personal payment from vaccine manufacturers. JP is the 43

Chief Executive of Group B Strep Support, a charity which offers support and information to 44

families affected by Group B strep, informs health professional about the prevention of Group B 45

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strep infection and supports research into to preventing these infections in newborn babies. The 46

remaining authors have no potential conflicts of interest to declare. 47

Keywords: pregnancy, attitudes, clinical trial, Group B streptococcus, maternal immunisation 48

Word count: 2900 49

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Abstract (Word count 300) 50

51

Objectives 52

The aim of this analysis was to explore factors influencing the likelihood of antenatal vaccine 53

acceptance of both routine UK antenatal vaccines (influenza and pertussis) and a hypothetical Group 54

B streptococcus (GBS) vaccine in order to improve understanding of how to optimise antenatal 55

immunisation acceptance, both in routine use and clinical trials. 56

Setting 57

An online survey distributed to women of child bearing age in the UK 58

Participants 59

1013 women aged 18-44 years in England, Scotland and Wales 60

Methods 61

Data from an online survey conducted to gauge the attitudes of 1013 women of child-bearing age in 62

England, Scotland and Wales to antenatal vaccination against GBS, was further analysed to determine 63

the influence of socio-economic status, parity, and age on attitudes to GBS immunisation, using 64

attitudes to influenza and pertussis vaccines as reference immunisations. Factors influencing 65

likelihood of participation in a hypothetical GBS vaccine trial were also assessed. 66

Results 67

Women with children were more likely to know about each of the three conditions surveyed (GBS: 45 68

vs. 26%, pertussis:79 vs. 63% influenza: 66 vs. 54%), to accept vaccination (GBS: 77 vs. 65%, 69

pertussis: 79 vs. 70% influenza: 78 vs. 68 %) and to consider taking part in vaccine trials (37 vs. 27% 70

for a hypothetical GBS vaccine previously tested in 500 pregnant women). For GBS, giving 71

information about the condition significantly increased the number of respondents who reported they 72

would be likely to receive the vaccine. Health professionals were the most important source of 73

information. 74

Conclusions 75

Increasing awareness about GBS would be required to optimise the uptake of a routine vaccine, with a 76

specific focus on informing women without previous children. More research specifically focussing 77

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on acceptability in pregnant women is required and, given the value to attached to input from 78

healthcare professionals, this group should be included in future studies. 79

80

Article summary: Strengths and limitations of this study 81

• This is a large scale study reporting the responses of over a thousand women of child bearing 82

age in the UK 83

• A wide range of clinically important questions were included regarding both current antenatal 84

vaccines and potential clinical trials which will be of relevance to practitioners and 85

researchers in the UK and worldwide 86

• A relatively small proportion of women (2%) were actually pregnant at the time of the study 87

and data on the women’s ethnicity were not collected 88

• Though an online survey enables a large number of participants to be included, it is limiting 89

in terms of the depth of information that can be gathered. However, it can provide a useful 90

preliminary study to a more in depth investigation using qualitative methods. 91

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Introduction 92

93

Group B streptococcus (GBS) is the commonest cause of sepsis and meningitis in infants up to the age 94

of three months with a significant morbidity and mortality [1, 2]. Current prevention strategies (using 95

intrapartum antibiotics) are aimed only at early onset Group B strep infections (occurring in the 1st 96

week of life) and there are a number of challenges in their application, in both developed and 97

developing countries [3]. Antenatal vaccination is therefore an attractive prospect, and clinical trial of 98

a candidate Group B strep vaccine are currently in phase II development. 99

Despite the promise of antenatal immunisation against Group B strep, it is important to be mindful 100

that uptake rates for existing antenatal vaccines are relatively low. In England, antenatal influenza 101

immunisation uptake was 44.1% in 2014/2015 [4], despite clear benefits for both mother and child 102

[5]. Similarly, although antenatal immunisation against neonatal pertussis has an effectiveness of 91% 103

[6] and has been shown to be safe [7], uptake rates in the UK are currently at 56.4%, a contributing 104

factor to the continuing tragedy of infant deaths from this illness [8]. It is therefore evident that simply 105

the availability of a safe and effective antenatal vaccine does not guarantee that it will be accepted by 106

pregnant women, and it is important to consider the relevance of this for antenatal Group B strep 107

immunisation. 108

109

In a previously published online survey [9] we reported that 72% of British women of child bearing 110

age described themselves as ‘likely’ to receive a (hypothetical) antenatal vaccine against Group B 111

strep, a figure that increased to 82% when further information about invasive Group B strep disease 112

was provided. Presented here is a detailed analysis of the relative differences in attitudes across 113

subgroups of age, disease knowledge and parental status to determine factors associated with 114

increased likelihood of vaccine acceptance or refusal. 115

116

117

Methods 118

119

120

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An online survey assessed awareness, perceptions of seriousness, and acceptability of antenatal 121

vaccines for three conditions; “Whooping cough (also called pertussis) in new-born babies”, 122

“Influenza in women while pregnant” and “Group B streptococcus (Group B strep) infection in new-123

born babies”. The full survey questions and response categories are included in table 1. For the 124

question “How serious do you think the following conditions are?” a non-infectious condition, 125

“Heavy bleeding in pregnancy”, was used as a comparison as it was assumed the majority of women 126

would consider this a serious condition. A five-level Likert scale was used for all questions with the 127

exception of one free-text answer. 128

129

A link to the survey was emailed to a nationally representative sample of 1221 women aged between 130

18 and 44 years in England, Scotland and Wales by a market research company (ComRes, London, 131

13-17 September 2013). These women had previously agreed to receive emails from ComRes with 132

surveys on a range of topics including health, politics and social issues. 133

134

Demographic details were also collected including age, social class, region, and whether or not the 135

respondent had any children or was planning to have more children. No personal identifying 136

information was collected. Respondents were assigned a social class based on their reported 137

occupation according to the Market Research Society guidelines [10]. Social classes were defined 138

according to the National Readership Survey classifications (available from http://www.nrs.co.uk/nrs-139

print/lifestyle-and-classification-data/social-grade/) and ranged from A to E, with A defined as being 140

the highest social class and E the lowest. Weighting adjustments were applied to ensure a nationally 141

representative sample. 142

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143

Statistical comparisons between groups were carried out using Chi-square tests, Fisher’s exact test or 144

Chi-square test for trend using a software package (Graphpad prism 6). For clarity of presentation in 145

the tables, answers to questions 2, 3, 4, 5, 7, and 8 were collapsed into “Don’t know what it is”, 146

“Know what it is” and “Have been directly affected” for question 2;- “Serious”, “Not serious” and 147

“Don’t know” for question 3;- “Likely”, “Unlikely” and “Don’t know” for questions 4, 5 and 7, and 148

“Important”, “Not important” and “Don’t know” for question 8. Where significant differences were 149

found between subcategories, for example “Never heard of it” and “Heard of it but don’t know what it 150

is” in question 2, these are indicated in the text. The full breakdown of answers is publically available 151

at http://www.comres.co.uk/poll/1028/gbs-vaccination-survey.htm. Free text responses to the 152

question, “Why would you be willing/unwilling to have a Group B strep vaccine in pregnancy?” were 153

analysed for recurrent themes and grouped accordingly, for example, “To protect my baby’s health” 154

or “Do not like/believe in vaccines.” 155

156

Quality control measures used to ensure respondents were paying due attention included a series of 157

logic checks such as matching date of birth with age band and asking participants to identify shapes 158

and colours. 159

160

161

Results 162

Of the 1221 women surveyed, 1013 returned usable answers (83%). Of those who did not, 138 (11%) 163

did not complete the survey, 13 (1%) did not meet the inclusion criteria (e.g. incorrect age or gender), 164

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12 (1%) completed the survey after the recruitment target had been reached and 43 (4%) were 165

discounted as they failed quality control. The proportions of respondents with and without children 166

are shown in figure 1 and the numbers in each age category in table 2. Twenty-five percent of the 167

respondents were in social classes A and B (higher and intermediate managerial/professional), 29% in 168

C1 (supervisory, clerical and junior managerial/professional), 17% in C2 (skilled manual) and 29% in 169

DE (semi-skilled, unskilled and unemployed). 170

171

Factors influencing awareness and attitudes to pertussis, influenza and Group B strep 172

Though similar proportions of respondents had been directly affected by each of the conditions 173

(pertussis 5%, influenza 3% and Group B strep 4%), less was known about Group B strep compared 174

to pertussis or influenza (“Never heard of” – pertussis: 6%; influenza: 14%; Group B strep: 29%, 175

p<0.0001). Those with children were significantly more likely than those without to know about each 176

condition (see table 2), as were older women compared to younger. However, as expected, older 177

women were also more likely to have children (percentage with children: 18-24yrs: 26%, 25-34yrs: 178

54%. 35-44yrs: 74%, p<0.0001). There were no statistically significant differences in awareness by 179

social class. 180

181

Older women, those with children, and those with knowledge of the relevant condition were more 182

likely to consider pertussis and Group B strep to be serious; for influenza the differences were not 183

significant (table 2). Generally, a higher proportion of respondents rated pertussis as more serious 184

compared to both influenza and Group B strep (pertussis 88% vs. influenza 82% p= 0.0002, pertussis 185

88% vs. Group B strep 79%, p<0.0001). However, of those who reported that they knew what the 186

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specific condition was or had experienced it themselves; 92% rated both pertussis and Group B strep 187

as either very serious or fairly serious. A higher proportion of these respondents who knew about 188

Group B strep also rated it as very serious, rather than fairly serious compared to pertussis (67% vs. 189

59%, p=0.0037). 190

191

Factors influencing attitudes to immunisation and clinical trials 192

The likelihood of accepting antenatal vaccination for all three conditions was not affected by age 193

(table 2) or social class (pertussis: AB 77% C1 73% C2 79% DE 72%; influenza: AB 74% C1 69% 194

C2 77% DE 69% and Group B strep: AB 75% C1 68% C2 76% DE 70%; all comparisons non-195

significant). Those who already had children or knew about the condition were significantly more 196

likely to be willing to receive a vaccine in pregnancy (table 2). Giving information about Group B 197

strep significantly increased the likelihood of accepting an antenatal vaccine in all groups (table 3). 198

199

Eight-hundred and ninety-eight respondents commented in the free text section about the reasons why 200

they would or would not accept antenatal Group B strep vaccination. Of those who reported they 201

would be likely to accept the vaccine, the most frequently expressed views were a desire “to protect 202

my baby/baby’s health” (27%) and the vaccine being a preventive measure (15%). Forty-three 203

respondents stated that they would need more information before making a final decision and 12 204

questioned the risks/safety of the vaccine. Of those who would be unwilling to have an antenatal 205

Group B strep vaccine, 24% (16/63) stated they did not like/believe in vaccines with the next most 206

common issue being that they required more information (19%, 13/63) or felt there was a lack of 207

safety evidence (17%, 11/63). 208

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209

A specific recommendation for use by the National Health Service (NHS), as opposed to the vaccine 210

simply being licensed and available, significantly increased the likelihood of respondents accepting 211

the Group B strep vaccine (79 vs. 52%, p<0.0001), proportions that remained higher in those with 212

previous knowledge about Group B strep (table 4). 213

214

A smaller proportion of women were likely to receive an antenatal Group B strep vaccine as part of a 215

research study than if licensed (42% [if previously given to 5000 women] or 32% [if previously given 216

to 500 pregnant women] vs. 52% (if licensed but not routinely recommended). In early stage 217

development (i.e. vaccine administered to fewer than 500 pregnant women) previous knowledge of 218

Group B strep increased the likelihood of respondents being willing to take part in a research study, 219

however it made no difference to this decision if the vaccine had been given to 5000 pregnant women 220

(table 4). Age and social class made no difference to the proportion of women willing to take part in 221

Group B strep vaccine research but a higher percentage of those who already had children reported 222

they would be likely to be willing to receive a Group B strep vaccine as part of a clinical trial (table 223

4). 224

225

Sources of Advice 226

The importance to women of advice from various sources in making decisions about antenatal 227

vaccination is shown in figure 2. General practitioners were the source of advice rated as important by 228

the highest proportion of respondents (87%) closely followed by midwives (84%). Twenty percent 229

more women felt written NHS hand-outs were more important compared to Internet sources such as 230

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parent forums (78 vs 58%) and half indicated that the media was not an important source of advice for 231

them. Generally, older respondents (35-44yrs) were more likely to rate advice from maternity health 232

professionals as important than the youngest age group (Midwife: 18-24yrs-79%, 35-44yrs- 87%, 233

p<0.01. Obstetrician: 18-24yrs-69%, 35-44yrs-86%, p<0.0001), women aged 25-34yrs also followed 234

this trend (group differences statistically significant for obstetricians but not midwives). However 235

younger women were more likely to rate advice from friends and family as important (18-24yrs-72%, 236

25-34yrs- 64% 35-44yrs-62%, p<0.005). There were no significant age group differences in ratings 237

for partners, the Internet or the media. Those with children rated each of the sources as more 238

important than those without children, although those without children were more likely to answer 239

“don’t know”. 240

241

242

Discussion 243

244

245

These findings emphasise the critical importance of information about Group B strep to optimise 246

uptake of an antenatal vaccine against Group B strep, and that this may need to be specifically 247

targeted at women in their first pregnancy. Even a brief explanation about Group B strep increased the 248

likelihood of vaccine acceptance by 7-13% and a specific national recommendation for its use 249

significantly increased the potential uptake rate. Women of child-bearing age rate the importance of 250

advice from healthcare professionals, particularly their GP, very highly. 251

The potential for vaccination against Group B strep is particularly important as a trivalent 252

glycoconjugate vaccine has recently been trialled in over 300 pregnant women with no vaccine related 253

safety concerns and large scale clinical trials are likely to begin in the near future [11, 12]. Universal 254

antenatal vaccination against Group B strep could have several advantages over intrapartum 255

antibiotics. It would most likely protect against both early- and late-onset disease, while intrapartum 256

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antibiotics are only able to prevent early-onset infection. Concerns about antibody resistance and the 257

practical issue of administering intravenous antibiotics at least two hours before birth would no longer 258

be relevant. This is particularly important as in one UK study, 81% of mothers whose babies went on 259

to develop Group B strep disease had not received adequate intrapartum antibiotics, despite having 260

risk factors [13]. Primary prevention through vaccination could potentially avoid these situations, 261

however more information is needed on the immunogenicity and safety of the vaccine and, most 262

importantly, whether or not it would be acceptable to pregnant women. 263

While it is encouraging that over 70% of respondents reported that would be likely to have antenatal 264

vaccinations against the three conditions surveyed, in reality vaccine uptake is much lower. The peak 265

uptake for antenatal pertussis vaccine in England was 61.5% in November 2013 and has since fallen 266

[8, 14], despite guidelines that it should be routinely offered to all pregnant women in the UK between 267

28 and 38 weeks’ gestation [15]. The percentage of pregnant women receiving the influenza vaccine, 268

which is recommended for all pregnant women in the UK regardless of gestation during the influenza 269

season, is only around 44.1% [4]. The reasons for these low rates are varied and much of the 270

published work has focused on influenza vaccination in pregnancy. There is less information 271

regarding attitudes towards antenatal Group B strep vaccination, but this is a growing area of research. 272

A recently published survey of 231 pregnant or recently delivered women in the USA showed 273

remarkably similar results to this survey in that 79% of respondents indicated they would be likely to 274

have a Group B strep vaccine in pregnancy [16]. Although 90% indicated they were concerned about 275

the safety of new antenatal vaccines, 95% of those surveyed responded that they generally followed 276

their healthcare professional’s recommendations. A Canadian qualitative study also found healthcare 277

professional’s recommendation would be a major factor in whether or not they would accept the 278

vaccine, and concerns about safety were also raised [17]. Our findings suggest that while there are 279

certain groups who may be more receptive to antenatal vaccination, there are others, such as women 280

in their first pregnancy, who may require additional input to encourage vaccine uptake. These women 281

may be more accepting if the antenatal vaccines are nationally recommended and may require extra 282

time and provision of information to optimise discussion of vaccination options, particularly focussing 283

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on the nature and seriousness of the conditions which are being vaccinated against. A number of 284

strategies to promote antenatal vaccine uptake have been tried, again particularly focusing on 285

immunisation against influenza. In Stockport, Greater Manchester, UK, antenatal influenza 286

vaccination uptake increased by almost 15% over one year through concentrated efforts using local 287

media/social media, establishing links between midwifery and GP services, improving IT services, 288

education of staff and good leadership [18]. Similarly an Australian campaign based on raising health 289

professionals’ awareness of antenatal influenza vaccination through lectures and meetings, new 290

patient information booklets and visual reminders on patient notes increased influenza vaccine uptake 291

from 30 to 40% [19]. Our results also indicate that knowledge about the condition being prevented 292

and support from healthcare professionals is key, and even brief interventions, such as the short 293

paragraph about Group B strep used in this survey, can significantly impact on the likelihood of 294

vaccine uptake. A number of women commented on their desire for further information about the 295

vaccine therefore it is important that evidence based information on antenatal vaccines is available for 296

pregnant women and the healthcare professionals caring for them. The importance attributed to advice 297

from healthcare professionals, indicates it is vital that these professionals are also well-informed and 298

motivated to promote antenatal vaccination. 299

300

There are a number of limitations to these findings which must be acknowledged. Respondents to the 301

survey had volunteered to receive such questionnaires on multiple occasions and on various topics 302

and therefore may be more open to research in general. There were few pregnant women within the 303

sample and it is the views of these women, for whom the questions are not merely theoretical, which 304

are key. However the sample was relatively large and representative in terms of age, geography and 305

social class, and therefore provides a useful framework on which to build future work. Of note, data n 306

the women’s ethnicity were not collected which may be an important factor. The nature of an online 307

survey also means that in-depth exploration of the decision making process is not possible and more 308

detail is needed on women’s information requirements and how this should be delivered. Other details 309

are lacking, such as how women self-defined being directly affected by the condition. The rates 310

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reported here are higher than invasive disease rates and some of those without children also 311

considered themselves to have been directly affected by each of the conditions suggesting response 312

bias. This may have been the results of confusion over what was being asked in this question or this 313

group may contain relatives/friends of affected parents or women who have had a positive Group B 314

strep swab in pregnancy, rather than an affected child. However this is consistent across all the 315

conditions surveyed and it seems that this experience is sufficient to sway attitudes toward Group B 316

strep. 317

It is with these limitations in mind that further research on the acceptability of Group B strep 318

immunisation in pregnant women in the UK is being conducted using focus groups, interviews and 319

questionnaires to specifically obtain the views of pregnant women and maternity healthcare 320

professionals. If these findings support the data presented here then, dependent on the development of 321

an effective and safe vaccine, immunisation of pregnant women against Group B strep could be the 322

next major breakthrough in the prevention of neonatal sepsis and meningitis. 323

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1. Okike, I.O., et al., Trends in bacterial, mycobacterial, and fungal meningitis in

England and Wales 2004-11: an observational study. Lancet Infect Dis, 2014. 14(4):

p. 301-7.

2. Stoll, B.J., et al., Early onset neonatal sepsis: the burden of group B Streptococcal

and E. coli disease continues. Pediatrics, 2011. 127(5): p. 817-26.

3. Royal College of Obstetricians and Gynaecologists, The prevention of early-onset

Group B streptococal disease. 2012: Green Top guidelines No 36.

4. Public Health England, Influenza immunisation programme for England: Data

collection survey season 2014-2015. 2015, PHE publications gateway number:

2015046.

5. Zaman, K., et al., Effectiveness of maternal influenza immunization in mothers and

infants. N Engl J Med, 2008. 359(15): p. 1555-64.

6. Amirthalingam, G., et al., Effectiveness of maternal pertussis vaccination in England:

an observational study. Lancet, 2014.

7. Donegan, K., B. King, and P. Bryan, Safety of pertussis vaccination in pregnant

women in UK: observational study. BMJ, 2014. 349: p. g4219.

8. Public Health England, Prenatal pertussis immunisation programme 2014/2015:

Annual vaccine coverage report for England. 2015, PHE publications gateway

number 2015282.

9. McQuaid, F., et al., Attitudes towards vaccination against group B streptococcus in

pregnancy. Arch Dis Child, 2014 Jul;99(7):700-1.

10. Market Reseach Society, Occupational Groupings: A Job Dictionary. Sixth ed. 2006.

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11. Madhi SA, L.-R.G., Koen A et al., Safety and Immunogenicity of an investigational

maternal trivalent vaccine to prevent perinatal group B streptococcus (GBS)

infection. 2013: ESPID conference 2013, 30th May.

12. Slobod, K., Novartis Group B streptococcus vaccine programme. 2013, Meningitis

Research Foundation Conference 2013.

13. Vergnano, S., et al., Missed opportunities for preventing group B streptococcus

infection. Arch Dis Child Fetal Neonatal Ed, 2010. 95(1): p. F72-3.

14. Publich Health England, Pertussis vaccine coverage for pregnant women by month.

2013. Available from https://www.gov.uk/government/statistics/pertussis-vaccine-

uptake-in-pregnant-women-october-2012-to-march-2014

15. England, P.H. Pertussis (whooping cough) immunisation for pregnant women.

Updated March 2014; Available from:

http://www.hpa.org.uk/Topics/InfectiousDiseases/InfectionsAZ/WhoopingCough/Im

munisationForPregnantWomen/.

16. Dempsey, A.F., et al., Acceptability of a hypothetical group B strep vaccine among

pregnant and recently delivered women. Vaccine, 2014. 32(21): p. 2463-8.

17. Patten, S., et al., Vaccination for Group B Streptococcus during pregnancy: attitudes

and concerns of women and health care providers. Soc Sci Med, 2006. 63(2): p. 347-

58.

18. Baxter, D., Approaches to the vaccination of pregnant women: experience from

Stockport, UK, with prenatal influenza. Hum Vaccin Immunother, 2013. 9(6): p.

1360-3.

19. McCarthy, E.A., et al., Improving influenza vaccination coverage in pregnancy in

Melbourne 2010-2011. Aust N Z J Obstet Gynaecol, 2012. 52(4): p. 334-41.

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Figure 1: Distribution of respondents by parental status. N=1013 women aged 18-44 years.

No children and

don't expect to

have any

17%

1 or more children,

don't plan to have any

more

37%

1 or more children

and plan to have

more

16%

Currently pregnant

2%

No children but plan

to have in future

28%

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Figure 2: The important of advice from various sources of information when making decisions on antenatal vaccination

0

10

20

30

40

50

60

70

80

90

100

% of respondants

Important Don't know Not important

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Table 1: Survey questions and possible responses

Question

Possible responses

1. Which one of the following statements best

describes your current situation?

a) I have one or more children and don’t plan

to have any more

b) I have one or more children and plan to have more

c) I am / my partner is currently pregnant

d) I don’t have any children now, but hope to have one or more children in the future

e) I don’t have any children and don’t expect

to in the future

2. How familiar are you with the following

conditions?

• Whooping cough (also called pertussis) in new-born

babies

• Influenza in women while pregnant

• Group B streptococcus (Group B strep) infection in

new-born babies

a) I have never heard of it

b) I have heard of it, but I don’t know what it

is

c) I have heard of it, and I know what it is

d) I know what it is, and I have been affected

by it directly

3. How serious do you think the following conditions

are?

• Heavy bleeding in pregnancy (for mother or new-

born child)


babies



new-born babies

a) Very serious

b) Fairly serious

c) Not very serious

d) Not serious at all e) Don’t know

4. How likely or unlikely would you be willing to

receive the following vaccines during pregnancy?

• Vaccine against whooping cough (Pertussis)

• Vaccine against influenza

• Vaccine against Group B Strep infection

a) Very likely

b) Fairly likely

c) Fairly unlikely

d) Very unlikely

e) Don’t know

Information provided about Group B strep

Group B Strep is the UK's most common cause of meningitis and life-threatening infection in newborn babies.

About 20% of UK women carry Group B Strep bacteria without having any symptoms. Babies can be exposed at

birth and afterwards from the mother and from other sources. Most will not develop infection but about 600—700

babies a year in the UK do. Currently, antibiotics can be given during labour if the mother is considered to be at high risk of having a baby with Group B Strep infection, but this does not prevent all infections.

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A vaccine for pregnant women to protect their babies against Group B Strep is being developed. This vaccine has so

far been given to many adults and to a small number of pregnant women in research studies. These studies have

found no evidence of harm to the women or their unborn babies and the results suggest than the vaccine could

prevent most Group B Strep infections in babies.

5. After reading the description above, how likely or

unlikely would you be willing to receive a vaccine

against Group B Strep during pregnancy?

a) Very likely

b) Fairly likely

c) Fairly unlikely

d) Very unlikely e) Don’t know

6. Could you explain why you would be likely/

unlikely to be willing to receive a vaccine against

Group B Strep during pregnancy?

a) __________________

b) I prefer not to say

7. Specifically, how likely or unlikely would you be

willing to receive a Group B Strep vaccine during

pregnancy in each of the following situations?

• As part of a research study looking at how well this

vaccine protects infants against Group B Strep,

before the vaccine is licensed (approved for routine use in pregnancy) if the vaccine had been given to

500 pregnant women without significant safety

concerns


vaccine protects infants against Group B Strep, before the vaccine is licensed (approved for routine

use in pregnancy) if the vaccine had been given to

5000 pregnant women without any significant safety concerns

• If the vaccine was licensed (approved for use), but

not specifically recommended for routine use by the

NHS

• If the vaccine was licensed and recommended for

routine use by the NHS

a) Very likely

b) Fairly likely c) Fairly unlikely

d) Very unlikely

e) Don’t know

8. Please indicate how important, or otherwise, you

would consider the advice of each of the following

in making a decision as to whether or not you

would be comfortable to receive (or for your

partner to receive) a Group B Strep vaccine

during pregnancy.

• Partner

• A midwife

• An obstetrician

• Your GP

• Written hand-outs provided by the NHS

• Information on the internet, e.g. parent forums

• The media

• Friends and family

• Other

• Very important

• Fairly important

• Not very important

• Not at all important

• Don’t know

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How serious would you

consider the following

conditions?

18-

24yrs

(% of

n= 239)

25-

34yrs

(% of

n=359)

35-

44yrs

(% of

n=415)

p- value

Children

(% of n=

570)

No

children

(% of

n=443)

p-value

Know

what it is

(% of

n**)

Don’t

know what

it is

(% of n**)

p- value

Heavy

bleeding in

pregnancy

Serious 91 94 96 0.03 96 91 0.0011

Don’t

know

5 5 4 2 7

Not

serious

4 1 0 0.002 1 2 NS

Pertussis Serious 82 86 94 <0.0001 92 83 <0.0001 92 79 <0.0001

Don’t

know

11 9 5 5 12 4 18

Not

serious

6 4 1 0.003 3 5 NS 4 3 NS

Influenza Serious 81 80 85 NS 85 80 NS 88 74 <0.0001

Don’t

know

14 12 8 8 16

5 21

Not

serious

5 8 6 NS 8 4 0.0268

7 5 NS

Group B

strep

Serious 72 75 86 <0.0001 84 72 <0.0001 92 71 <0.0001

Don’t

know

21 20 12 12 24 4 26

Not serious

7 4 1 0.0014 3 4 NS 5 3 NS

How likely would you be

to have a vaccine for the

following conditions in

pregnancy?

18-

24yrs

(% of

n= 239)

25-

34yrs

(% of

n=359)

35-

44yrs

(% of

n=415)

p- value

Children

(% of n=

570)

No

children

(% of

n=443)

p-value

Know

what it is

(% of

n**)

Don’t

know what

it is

(% of n**)

p- value

Pertussis Likely 75 76 72 NS 79 70 0.0018 77 67 0.0013

Don’t

know

18 15 19 12 23 44 25

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Unlikely 6 9 9 NS 9 7 NS 8 8 NS

Influenza Likely 73 72 70 NS 75 68 0.0211 76 65 0.0002

Don’t

know

18 16 18 12 23

11 26

Unlikely 9 12 12 NS 13 9 0.0437 12 9 NS

Group B

strep (pre

information)

Likely 72 72 72 NS 77 65 <0.0001 79 67 <0.0001

Don’t know

22 19 20 14 28 11 25


Group B

strep (post

information)

Likely 80 81 85 NS 86 77 <0.0001 86 80 0.0217

Don’t know

13 11 10 7 16 7 14


Table 2: Survey responses by age, parental status and previous knowledge of the condition. Answers were mutually exclusive and p values indicate

differences between groups for that answer versus all other answers. NS = non-significant i.e. p>0.05. Percentages are rounded to nearest whole number.

*Respondents self-defined whether they had been directly affected, therefore this does not necessarily refer to their own children.

** Know what it is: pertussis n=727, flu n=609, Group B strep n=374. Don’t know what it is: n=286, flu n=404, Group B strep n=639

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Group

Pre info (%)

Post info (%) p-value

18-24yrs (n= 239) 185 (72) 208 (80) 0.0236

25-34yrs (n=359)

255 (72)

289 (81) 0.0038

35-44yrs (n=415)

286 (72)

337 (85) <0.0001

Children (n= 557)

428 (77)

481 (86) <0.0001

No children (n=456)

297 (65)

352 (77) <0.0001

Prior Knowledge

(n=374)

297 (79)

321 (86) 0.0262

No prior knowledge

(n=639)

429 (67) 512 (80) <0.0001

Table 3: Effect of providing information about Group B strep (see table 1) on likelihood of being willing to receive a Group B strep vaccine in pregnancy

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to have a Group B strep

vaccine in the following

situations?

18-

24yrs

(% of

n=239)

25-

34yrs

(% of

n=359)

35-

44yrs

(% of

n=415)

p- value Children

(% of

n=557)

No

children

(% of

n=456)

p-value Know

what it is

(% of

n=374)

Don’t

know what

it is

(% of

n=639)

p- value

Licensed and

recommended

Likely 78 79 80 NS 81 76 NS 83 77 0.0163

Don’t know

15 12 14 11 16 10 16


Licensed, not

specifically

recommended

Likely 56 52 50 NS 52 52 NS 57 49 0.0132

Don’t

know

17 19 21 18 21 16 21

Unlikely 27 29 29 NS 30 27 NS 27 30 NS

Part of a

research study,

previously

tested in 5000

pregnant

women

Likely 50 44 38 0.0139 46 40 NS 47 41 NS

Don’t

know

19 15 21 16 21 16 20

Unlikely 31 40 41 0.0247

38 38 NS 38 38 0.0246

Research

study,

previously

tested in 500

pregnant

women

Likely 34 35 28 NS 37 27 0.0009 36 30 0.0435

Don’t

know

21 17 24 19 23 18 23

Unlikely 45 48 47 NS 44 50 NS 46 47 NS

Table 4: Likelihood of accepting Group B strep vaccine in four difference scenarios by age, parental status and previous knowledge of Group B strep. Answers were mutually exclusive and p values indicate differences between groups for that answer versus all other answers. NS = non-significant i.e. p>0.05.

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1

STROBE Statement—checklist of items that should be included in reports of observational studies

Item

No Recommendation

Title and abstract 1 (a) Indicate the study’s design with a commonly used term in the title or the abstract

The phrase “A survey” has been included in the title to indicate the design (title

page 1)

(b) Provide in the abstract an informative and balanced summary of what was done

and what was found

The abstract can be found on page 4

Introduction

Background/rationale 2 Explain the scientific background and rationale for the investigation being reported

This is explained on page 6: Introduction

Objectives 3 State specific objectives, including any prespecified hypotheses

The objectives are stated in the last paragraph of the introduction on page 6

Methods

Study design 4 Present key elements of study design early in the paper

The design in discussed in the methods section, page 6-8 and the survey itself in

table 1

Setting 5 Describe the setting, locations, and relevant dates, including periods of recruitment,

exposure, follow-up, and data collection

Described in methods section, page 6-8,

Setting/location: Online survey sent to women of child bearing age throughout

Scotland, England and Wales

Recruitment: 13-17 September 2013

Exposure: N/A

Follow up: One off survey

Data collection: Online by Comres market research company

Participants 6 (a) Cohort study—Give the eligibility criteria, and the sources and methods of

selection of participants. Describe methods of follow-up

Case-control study—Give the eligibility criteria, and the sources and methods of case

ascertainment and control selection. Give the rationale for the choice of cases and

controls

Cross-sectional study—Give the eligibility criteria, and the sources and methods of

selection of participants

Details are given in paragraph 2 and 3 of the methods and paragraph 1 of the

results. Further demographic information is given in results section, paragraph

1 (page 8), figure 1 and table 2.

(b) Cohort study—For matched studies, give matching criteria and number of

exposed and unexposed

Case-control study—For matched studies, give matching criteria and the number of

controls per case

N/A

Variables 7 Clearly define all outcomes, exposures, predictors, potential confounders, and effect

modifiers. Give diagnostic criteria, if applicable

Not fully applicable for this study (see cover letter). All respondents were given

the same extra information during the survey (table 1). Potential

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2

confounders/other variables are discussed throughout the results section and the

discussion.

Data sources/

measurement

8* For each variable of interest, give sources of data and details of methods of

assessment (measurement). Describe comparability of assessment methods if there is

more than one group

All data was supplied through the online survey, details are described in

methods paragraph 3-5 (page 8-9)

Bias 9 Describe any efforts to address potential sources of bias

The potential for bias (e.g. that respondents to the survey may be more inclined

to participate in research in general) is discussed in the discussion, paragraph 4

(page 14). Weighting was applied to ensure a nationally representative sample.

Study size 10 Explain how the study size was arrived at

A sample size of 1000 was judged to be sufficient give a nationally representative

view on the issues with the available funding.

Quantitative variables 11 Explain how quantitative variables were handled in the analyses. If applicable,

describe which groupings were chosen and why

Analysis is discussed in methods section paragraph 4 (page 7) and throughout

the results and discussion

Statistical methods 12 (a) Describe all statistical methods, including those used to control for confounding

Statistical methods are described in methods paragraph 4, page 7

(b) Describe any methods used to examine subgroups and interactions


(c) Explain how missing data were addressed

Details are given in results paragraph 1, page 8

(d) Cohort study—If applicable, explain how loss to follow-up was addressed

Case-control study—If applicable, explain how matching of cases and controls was

addressed

Cross-sectional study—If applicable, describe analytical methods taking account of

sampling strategy

N/A

(e) Describe any sensitivity analyses

Continued on next page

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3

Results

Participants 13* (a) Report numbers of individuals at each stage of study—eg numbers potentially eligible,

examined for eligibility, confirmed eligible, included in the study, completing follow-up, and

analysed

Discussed in results paragraph 1, page 8

(b) Give reasons for non-participation at each stage N/A

(c) Consider use of a flow diagram N/A

Descriptive

data

14* (a) Give characteristics of study participants (eg demographic, clinical, social) and information

on exposures and potential confounders

Given in results section paragraph 1 (page 8) , figure 1 and table 2

(b) Indicate number of participants with missing data for each variable of interest


(c) Cohort study—Summarise follow-up time (eg, average and total amount)

N/A

Outcome data 15* Cohort study—Report numbers of outcome events or summary measures over time

Case-control study—Report numbers in each exposure category, or summary measures of

exposure

Cross-sectional study—Report numbers of outcome events or summary measures

All relevant results are reported in the results section and tables 2-4, figure 1-2

Main results 16 (a) Give unadjusted estimates and, if applicable, confounder-adjusted estimates and their

precision (eg, 95% confidence interval). Make clear which confounders were adjusted for and

why they were included

N/A

(b) Report category boundaries when continuous variables were categorized

Tables 2-4

(c) If relevant, consider translating estimates of relative risk into absolute risk for a meaningful

time period

N/A

Other analyses 17 Report other analyses done—eg analyses of subgroups and interactions, and sensitivity

analyses

N/A

Discussion

Key results 18 Summarise key results with reference to study objectives

Discussion paragraph 1, page 12

Limitations 19 Discuss limitations of the study, taking into account sources of potential bias or imprecision.

Discuss both direction and magnitude of any potential bias


Interpretation 20 Give a cautious overall interpretation of results considering objectives, limitations, multiplicity

of analyses, results from similar studies, and other relevant evidence

Discussed throughout the discussion section, pages 12-14

Generalisability 21 Discuss the generalisability (external validity) of the study results

Discussed throughout discussion pages 12-14

Other information

Funding 22 Give the source of funding and the role of the funders for the present study and, if applicable,

for the original study on which the present article is based

Funding from Meningitis Now, on title page 2

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4

*Give information separately for cases and controls in case-control studies and, if applicable, for exposed and

unexposed groups in cohort and cross-sectional studies.

Note: An Explanation and Elaboration article discusses each checklist item and gives methodological background and

published examples of transparent reporting. The STROBE checklist is best used in conjunction with this article (freely

available on the Web sites of PLoS Medicine at http://www.plosmedicine.org/, Annals of Internal Medicine at

http://www.annals.org/, and Epidemiology at http://www.epidem.com/). Information on the STROBE Initiative is

available at www.strobe-statement.org.

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Factors influencing women’s attitudes towards antenatal vaccines, Group B streptococcus and clinical trial

participation in pregnancy: An on-line survey.

Journal: BMJ Open

Manuscript ID bmjopen-2015-010790.R1

Article Type: Research

Date Submitted by the Author: 10-Feb-2016

Complete List of Authors: McQuaid, Fiona; University of Oxford, Oxford Vaccine Group, NIHR Oxford Biomedical Research Centre, Department of Paediatrics, Jones, Christine; St George's, University of London, Paediatric Infectious

Diseases Research Group, Institute for Infection and Immunity, Stevens, Zoe; University of Oxford, Oxford Vaccine Group, NIHR Oxford Biomedical Research Centre, Department of Paediatrics, Plumb, Jane; Group B Strep support Hughes, Rhona; Royal Infirmary Edinburgh, Simpson Centre for Reproductive Health Bedford, Helen; UCL, Population, Policy and Practice Programme, UCL Institute of Child Health Voysey, Merryn; University of Oxford, Nuffield Department of Primary Care Health Sciences; University of Oxford, Oxford Vaccine Group, NIHR Oxford Biomedical Research Centre, Department of Paediatrics, Heath, Paul; St Georges, University of London, Paediatric Infectious

Diseases Research Group, Institute for Infection and Immunity, Snape, Matthew; University of Oxford, Oxford Vaccine Group, NIHR Oxford Biomedical Research Centre, Department of Paediatrics,

<b>Primary Subject Heading</b>:

Infectious diseases

Secondary Subject Heading: Obstetrics and gynaecology, Communication, Paediatrics

Keywords: pregnancy, attiitudes, clinical trial, Group B streptococcus, maternal immunisation


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Title: 1

Factors influencing women’s attitudes towards antenatal vaccines, Group B streptococcus and clinical 2

trial participation in pregnancy: An on-line survey. 3

Corresponding author: 4

Fiona McQuaid, Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the 5

NIHR Oxford Biomedical Research Centre, Oxford, United Kingdom. [email protected], 6

Tel/Fax 01865857420 7

Co-authors: 8

Christine Jones, Paediatric Infectious Diseases Research Group, Institute for Infection and Immunity, 9

St Georges, University of London, London, United Kingdom 10

Zoe Stevens, Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR 11

Oxford Biomedical Research Centre, Oxford, United Kingdom 12

Jane Plumb, Group B Strep Support, Haywards Heath, West Sussex, United Kingdom 13

Rhona Hughes, Simpson Centre for Reproductive Health, Royal Infirmary, Edinburgh, United 14

Kingdom 15

Helen Bedford, Population, Policy and Practice Programme, UCL Institute of Child Health, London, 16

United Kingdom 17

Merryn Voysey M.Biostat Department of Primary Care Health Sciences, University of Oxford, 18

Oxford, United Kingdom 19

Paul T Heath, Paediatric Infectious Diseases Research Group & Vaccine Institute, Institute for 20

Infection and Immunity, St Georges, University of London, London, United Kingdom 21

Matthew D Snape, Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the 22

NIHR Oxford Biomedical Research Centre, Oxford, United Kingdom 23

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Funding 24

This survey was funded by a grant from Meningitis Now (formerly Meningitis UK), grant 25

number 6000. The funders had no role in the preparation of this manuscript. 26

Contributorship statement 27

FM wrote the article which was reviewed by all authors. Data analysis was performed by FM, 28

MDS and MV. All authors contributed to the design of the online survey. 29

Data sharing statement 30

Additional data is available on the Comres website http://www.comres.co.uk/polls/gbs-31

vaccination-survey/ or from the authors on request 32

Acknowledgments 33

We would like to thank the respondents to the online survey and E. Di Antonio and Holly Wicks 34

(ComRes) for assistance with survey preparation. 35

Competing interests 36

P.T. Heath serves as a consultant to Novartis Vaccines regarding Group B strep vaccine 37

development. He receives no personal funding for this. MDS has participated in advisory boards 38

and/or been an investigator on clinical trials of vaccines sponsored by vaccine manufacturers 39

including Novartis Vaccines, GlaxoSmithKline, Pfizer, Crucell and Sanofi Pasteur. Payment for 40

these services was made to the University of Oxford Department of Paediatrics. MDS has had 41

travel and accommodation expenses paid to attend conferences by Novartis Vaccines and 42

GlaxoSmithKline. MDS has received no personal payment from vaccine manufacturers. JP is the 43

Chief Executive of Group B Strep Support, a charity which offers support and information to 44

families affected by Group B strep, informs health professional about the prevention of Group B 45

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strep infection and supports research into to preventing these infections in newborn babies. The 46

remaining authors have no potential conflicts of interest to declare. 47

Keywords: pregnancy, attitudes, clinical trial, Group B streptococcus, maternal immunisation 48

Word count: 2953 49

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Abstract 50

51

Objectives 52

To explore factors influencing the likelihood of antenatal vaccine acceptance of both routine UK 53

antenatal vaccines (influenza and pertussis) and a hypothetical Group B streptococcus (GBS) vaccine 54

in order to improve understanding of how to optimise antenatal immunisation acceptance, both in 55

routine use and clinical trials. 56

Setting 57

An online survey distributed to women of child bearing age in the UK 58

Participants 59

1013 women aged 18-44 years in England, Scotland and Wales 60

Methods 61

Data from an online survey conducted to gauge the attitudes of 1013 women of child-bearing age in 62

England, Scotland and Wales to antenatal vaccination against GBS, was further analysed to determine 63

the influence of socio-economic status, parity, and age on attitudes to GBS immunisation, using 64

attitudes to influenza and pertussis vaccines as reference immunisations. Factors influencing 65

likelihood of participation in a hypothetical GBS vaccine trial were also assessed. 66

Results 67

Women with children were more likely to know about each of the three conditions surveyed (GBS: 45 68

vs. 26%, pertussis:79 vs. 63% influenza: 66 vs. 54%), to accept vaccination (GBS: 77 vs. 65%, 69

pertussis: 79 vs. 70% influenza: 78 vs. 68 %) and to consider taking part in vaccine trials (37 vs. 27% 70

for a hypothetical GBS vaccine tested in 500 pregnant women). For GBS, giving information about 71

the condition significantly increased the number of respondents who reported they would be likely to 72

receive the vaccine. Health professionals were the most important reported source of information. 73

Conclusions 74

Increasing awareness about GBS, along with other key strategies, would be required to optimise the 75

uptake of a routine vaccine, with a specific focus on informing women without previous children. 76

More research specifically focussing on acceptability in pregnant women is required and, given the 77

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value to attached to input from healthcare professionals, this group should be included in future 78

studies. 79

80

Article summary: Strengths and limitations of this study 81

• This is a large scale study reporting the responses of over a thousand women of child bearing 82

age in the UK 83

• A wide range of clinically important questions were included regarding both current antenatal 84

vaccines and potential clinical trials which will be of relevance to practitioners and 85

researchers in the UK and worldwide 86

• A relatively small proportion of women (2%) were actually pregnant at the time of the study 87

and data on the women’s ethnicity were not collected 88

• Though an online survey enables a large number of participants to be included, it is limiting 89

in terms of the depth of information that can be gathered. However, it can provide a useful 90

preliminary study to a more in depth investigation using qualitative methods. 91

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Introduction 92

93

Group B streptococcus (GBS) is the commonest cause of sepsis and meningitis in infants up to the age 94

of three months with a significant morbidity and mortality [1, 2]. Current prevention strategies (using 95

intrapartum antibiotics) are aimed only at early onset Group B strep infections (occurring in the 1st 96

week of life) and there are a number of challenges in their application, in both developed and 97

developing countries [3]. Antenatal vaccination is therefore an attractive prospect, and clinical trial of 98

a candidate Group B strep vaccine are currently in phase II development. 99

Despite the promise of antenatal immunisation against Group B strep, it is important to be mindful 100

that uptake rates for existing antenatal vaccines are relatively low. In England, antenatal influenza 101

immunisation uptake was 44.1% in 2014/2015 [4], despite clear benefits for both mother and child 102

[5]. Similarly, although antenatal immunisation against neonatal pertussis has an effectiveness of 91% 103

[6] and has been shown to be safe [7], uptake rates in the UK are currently at 56.4%, a contributing 104

factor to the continuing tragedy of infant deaths from this illness [8]. It is therefore evident that simply 105

the availability of a safe and effective antenatal vaccine does not guarantee that it will be accepted by 106

pregnant women, and it is important to consider the relevance of this for antenatal Group B strep 107

immunisation. 108

109

This paper presents further analysis of a previously published online survey [9], in which we reported 110

that 72% of British women of child bearing age described themselves as ‘likely’ to receive a 111

(hypothetical) antenatal vaccine against Group B strep, a figure that increased to 82% when further 112

information about invasive Group B strep disease was provided. Presented here is a detailed analysis 113

of the relative differences in attitudes across subgroups of age, disease knowledge and parental status 114

to determine factors associated with increased likelihood of vaccine acceptance or refusal. 115

116

Methods 117

118

119

An online survey assessed awareness, perceptions of seriousness, and acceptability of antenatal 120

vaccines for three conditions; “Whooping cough (also called pertussis) in new-born babies”, 121

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“Influenza in women while pregnant” and “Group B streptococcus (Group B strep) infection in new-122

born babies”. Preferred sources of advice about antenatal vaccination were also investigated. The full 123

survey questions and response categories are included in table 1. For the question “How serious do 124

you think the following conditions are?” a non-infectious condition, “Heavy bleeding in pregnancy”, 125

was used as a comparison as it was assumed the majority of women would consider this a serious 126

condition. A five-level Likert scale was used for all questions with the exception of one free-text 127

answer. 128

129

A link to the survey was emailed to a nationally representative sample of 1221 women aged between 130

18 and 44 years in England, Scotland and Wales by a market research company (ComRes, London, 131

13-17 September 2013). These women had previously agreed to receive emails from ComRes with 132

surveys on a range of topics including health, politics and social issues. Participation was voluntary 133

and no personal identifying information was collected. Due to the nature of this survey, formal ethical 134

approval was not required. 135

136

Demographic details were also collected including age, social class, region, and whether or not the 137

respondent had any children or was planning to have more children. No personal identifying 138

information was collected. Respondents were assigned a social class based on their reported 139

occupation according to the Market Research Society guidelines [10]. Social classes were defined 140

according to the National Readership Survey classifications (available from http://www.nrs.co.uk/nrs-141

print/lifestyle-and-classification-data/social-grade/) and ranged from A to E, with A defined as being 142

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the highest social class and E the lowest. Weighting adjustments were applied to ensure a nationally 143

representative sample. 144

145

Statistical comparisons between groups were carried out using Chi-square tests, Fisher’s exact test or 146

Chi-square test for trend using a software package (Graphpad prism 6). For clarity of presentation in 147

the tables, answers to questions 2, 3, 4, 5, 7, and 8 were collapsed into “Don’t know what it is”, 148

“Know what it is” and “Have been directly affected” for question 2;- “Serious”, “Not serious” and 149

“Don’t know” for question 3;- “Likely”, “Unlikely” and “Don’t know” for questions 4, 5 and 7, and 150

“Important”, “Not important” and “Don’t know” for question 8. Where significant differences were 151

found between subcategories, for example “Never heard of it” and “Heard of it but don’t know what it 152

is” in question 2, these are indicated in the text. The full breakdown of answers is publically available 153

at http://www.comres.co.uk/poll/1028/gbs-vaccination-survey.htm. Free text responses to the 154

question, “Why would you be willing/unwilling to have a Group B strep vaccine in pregnancy?” were 155

analysed for recurrent themes and grouped accordingly, for example, “To protect my baby’s health” 156

or “Do not like/believe in vaccines.” 157

158

Quality control measures used to ensure respondents were paying due attention included a series of 159

logic checks such as matching date of birth with age band and asking participants to identify shapes 160

and colours. 161

162

Results 163

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Of the 1221 women surveyed, 1013 returned usable answers (83%). Of those who did not, 138 (11%) 164

did not complete the survey, 13 (1%) did not meet the inclusion criteria (e.g. incorrect age or gender), 165

12 (1%) completed the survey after the recruitment target had been reached and 43 (4%) were 166

discounted as they failed quality control. The proportions of respondents with and without children 167

are shown in figure 1 and the numbers in each age category in table 2. Twenty-five percent of the 168

respondents were in social classes A and B (higher and intermediate managerial/professional), 29% in 169

C1 (supervisory, clerical and junior managerial/professional), 17% in C2 (skilled manual) and 29% in 170

DE (semi-skilled, unskilled and unemployed). These social class percentages are similar to that of the 171

2011 household census for England and Wales [11]. 172

173

Factors influencing awareness and attitudes to pertussis, influenza and Group B strep 174

Though similar proportions of respondents had been directly affected by each of the conditions 175

(pertussis 5%, influenza 3% and Group B strep 4%), less was known about Group B strep compared 176

to pertussis or influenza (“Never heard of” – pertussis: 6%; influenza: 14%; Group B strep: 29%, 177

p<0.0001). Those with children were significantly more likely than those without to know about each 178

condition (see table 2), as were older women compared to younger. However, as expected, older 179

women were also more likely to have children (percentage with children: 18-24yrs: 26%, 25-34yrs: 180

54%. 35-44yrs: 74%, p<0.0001). There were no statistically significant differences in awareness by 181

social class. 182

183

Older women, those with children, and those with knowledge of the relevant condition were more 184

likely to consider pertussis and Group B strep to be serious; for influenza the differences were not 185

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significant (table 2). Generally, a higher proportion of respondents rated pertussis as more serious 186

compared to both influenza and Group B strep (pertussis 88% vs. influenza 82% p= 0.0002, pertussis 187

88% vs. Group B strep 79%, p<0.0001). However, of those who reported that they knew what the 188

specific condition was or had experienced it themselves; 92% rated both pertussis and Group B strep 189

as either very serious or fairly serious. A higher proportion of these respondents who knew about 190

Group B strep also rated it as very serious, rather than fairly serious compared to pertussis (67% vs. 191

59%, p=0.0037). 192

193

Factors influencing attitudes to immunisation and clinical trials 194

The likelihood of accepting antenatal vaccination for all three conditions was not affected by age 195

(table 2) or social class (pertussis: AB 77% C1 73% C2 79% DE 72%; influenza: AB 74% C1 69% 196

C2 77% DE 69% and Group B strep: AB 75% C1 68% C2 76% DE 70%; all comparisons non-197

significant). Those who already had children or knew about the condition were significantly more 198

likely to be willing to receive a vaccine in pregnancy (table 2). Giving information about Group B 199

strep significantly increased the likelihood of accepting an antenatal vaccine in all groups (table 3). 200

201

Eight-hundred and ninety-eight respondents commented in the free text section about the reasons why 202

they would or would not accept antenatal Group B strep vaccination. Of those who reported they 203

would be likely to accept the vaccine, the most frequently expressed views were a desire “to protect 204

my baby/baby’s health” (27%) and the vaccine being a preventive measure (15%). Forty-three 205

respondents stated that they would need more information before making a final decision and 12 206

questioned the risks/safety of the vaccine. Of those who would be unwilling to have an antenatal 207

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Group B strep vaccine, 24% (16/63) stated they did not like/believe in vaccines with the next most 208

common issue being that they required more information (19%, 13/63) or felt there was a lack of 209

safety evidence (17%, 11/63). 210

211

A specific recommendation for use by the National Health Service (NHS), as opposed to the vaccine 212

simply being licensed and available, significantly increased the likelihood of respondents accepting 213

the Group B strep vaccine (79 vs. 52%, p<0.0001), proportions that remained higher in those with 214

previous knowledge about Group B strep (table 4). 215

216

A smaller proportion of women were likely to receive an antenatal Group B strep vaccine as part of a 217

research study than if licensed (42% [if previously given to 5000 women] or 32% [if previously given 218

to 500 pregnant women] vs. 52% (if licensed but not routinely recommended). In early stage 219

development (i.e. vaccine administered to fewer than 500 pregnant women) previous knowledge of 220

Group B strep increased the likelihood of respondents being willing to take part in a research study, 221

however it made no difference to this decision if the vaccine had been given to 5000 pregnant women 222

(table 4). Age and social class made no difference to the proportion of women willing to take part in 223

Group B strep vaccine research but a higher percentage of those who already had children reported 224

they would be likely to be willing to receive a Group B strep vaccine as part of a clinical trial (table 225

4). 226

227

Sources of Advice 228

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The importance to women of advice from various sources in making decisions about antenatal 229

vaccination is shown in figure 2. General practitioners were the source of advice rated as important by 230

the highest proportion of respondents (87%) closely followed by midwives (84%). Twenty percent 231

more women felt written NHS hand-outs were more important compared to Internet sources such as 232

parent forums (78 vs 58%) and half indicated that the media was not an important source of advice for 233

them. Generally, older respondents (35-44yrs) were more likely to rate advice from maternity health 234

professionals as important than the youngest age group (Midwife: 18-24yrs-79%, 35-44yrs- 87%, 235

p<0.01. Obstetrician: 18-24yrs-69%, 35-44yrs-86%, p<0.0001), women aged 25-34yrs also followed 236

this trend (group differences statistically significant for obstetricians but not midwives). However 237

younger women were more likely to rate advice from friends and family as important (18-24yrs-72%, 238

25-34yrs- 64% 35-44yrs-62%, p<0.005). There were no significant age group differences in ratings 239

for partners, the Internet or the media. Those with children rated each of the sources as more 240

important than those without children, although those without children were more likely to answer 241

“don’t know”. 242

243

Discussion 244

245

246

These findings emphasise the critical importance of information about Group B strep to optimise 247

uptake of a potential antenatal vaccine, and that this may need to be specifically targeted at women in 248

their first pregnancy. Even a brief explanation about Group B strep increased the likelihood of vaccine 249

acceptance by 7-13% and a specific national recommendation for its use significantly increased the 250

potential uptake rate, however it is important to combine this information with other strategies to 251

promote uptake Women of child-bearing age rate the importance of advice from healthcare 252

professionals, particularly their GP, very highly. 253

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This survey forms part of a larger project funded by Meningitis Now entitled “Preparing the UK for 254

an effective Group B streptococcus vaccine”, and was designed to provide preliminary information on 255

the views of the UK population about GBS and a possible antenatal vaccine. The potential for 256

vaccination against Group B strep is particularly important as a trivalent glycoconjugate vaccine has 257

recently been trialled in over 300 pregnant women with no vaccine related safety concerns and large 258

scale clinical trials are likely to begin in the near future [12, 13]. Universal antenatal vaccination 259

against Group B strep could have several advantages over intrapartum antibiotics. It would most 260

likely protect against both early- and late-onset disease, while intrapartum antibiotics are only able to 261

prevent early-onset infection. Concerns about antibody resistance and the practical issue of 262

administering intravenous antibiotics at least two hours before birth would no longer be relevant. This 263

is particularly important as in one UK study, 81% of mothers whose babies went on to develop Group 264

B strep disease had not received adequate intrapartum antibiotics, despite having risk factors [14]. 265

Primary prevention through vaccination could potentially avoid these situations, however more 266

information is needed on the immunogenicity and safety of the vaccine and, most importantly, 267

whether or not it would be acceptable to pregnant women. 268

While it is encouraging that over 70% of respondents reported that would be likely to have antenatal 269

vaccinations against the three conditions surveyed, in reality vaccine uptake is much lower. The peak 270

uptake for antenatal pertussis vaccine in England was 61.5% in November 2013 and has since fallen 271

[8, 15], despite guidelines that it should be routinely offered to all pregnant women in the UK between 272

28 and 38 weeks’ gestation [16]. The percentage of pregnant women receiving the influenza vaccine, 273

which is recommended for all pregnant women in the UK regardless of gestation during the influenza 274

season, is only around 44.1% [4]. The reasons for these low rates are varied and much of the 275

published work has focused on influenza vaccination in pregnancy. 276

A number of strategies to promote antenatal vaccine uptake have been tried, again particularly 277

focusing on immunisation against influenza. In Stockport, Greater Manchester, UK, antenatal 278

influenza vaccination uptake increased by almost 15% over one year through concentrated efforts 279

using local media/social media, establishing links between midwifery and GP services, improving IT 280

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services, education of staff and good leadership [17]. Similarly an Australian campaign based on 281

raising health professionals’ awareness of antenatal influenza vaccination through lectures and 282

meetings, new patient information booklets and visual reminders on patient notes increased influenza 283

vaccine uptake from 30 to 40% [18]. Our results also indicate that knowledge about the condition 284

being prevented and support from healthcare professionals is key, and even brief interventions, such 285

as the short paragraph about Group B strep used in this survey, can significantly impact on the 286

likelihood of vaccine uptake. 287

There is less information regarding attitudes towards antenatal Group B strep vaccination, but this is a 288

growing area of research. A recently published survey of 231 pregnant or recently delivered women in 289

the USA showed remarkably similar results to this survey in that 79% of respondents indicated they 290

would be likely to have a Group B strep vaccine in pregnancy [19]. Although 90% indicated they 291

were concerned about the safety of new antenatal vaccines, 95% of those surveyed responded that 292

they generally followed their healthcare professional’s recommendations. A Canadian qualitative 293

study also found healthcare professional’s recommendation would be a major factor in whether or not 294

they would accept the vaccine, and concerns about safety were also raised [20]. Our findings suggest 295

that while there are certain groups who may be more receptive to antenatal vaccination, there are 296

others, such as women in their first pregnancy, who may require additional input to encourage vaccine 297

uptake. These women may be more accepting if the antenatal vaccines are nationally recommended 298

and may require extra time and provision of information to optimise discussion of vaccination 299

options, particularly focussing on the nature and seriousness of the conditions which are being 300

vaccinated against. 301

There are a number of limitations to these findings which must be acknowledged. Respondents to the 302

survey had volunteered to receive such questionnaires on multiple occasions and on various topics 303

and therefore may be more open to research in general. There were few pregnant women within the 304

sample and it is the views of these women, for whom the questions are not merely theoretical, which 305

are key. However the sample was relatively large and representative in terms of age, geography and 306

social class, and therefore provides a useful framework on which to build future work. Of note, data 307

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on the women’s ethnicity were not collected which may be an important factor. The nature of an 308

online survey also means that in-depth exploration of the decision making process is not possible and 309

more detail is needed on women’s information requirements and how this should be delivered. Other 310

details are lacking, such as how women self-defined being directly affected by the condition and why 311

such a high proportion of women who did not know what the conditions still rated them as serious. 312

The rates reported here are higher than invasive disease rates and some of those without children also 313

considered themselves to have been directly affected by each of the conditions suggesting response 314

bias. This may have been the results of confusion over what was being asked in this question or this 315

group may contain relatives/friends of affected parents or women who have had a positive Group B 316

strep swab in pregnancy, rather than an affected child. However this is consistent across all the 317

conditions surveyed and it seems that this experience is sufficient to sway attitudes toward Group B 318

strep. 319

It is with these limitations in mind that further research on the acceptability of Group B strep 320

immunisation in pregnant women in the UK is being conducted using focus groups, interviews and 321

questionnaires to specifically obtain the views of pregnant women and maternity healthcare 322

professionals. If these findings support the data presented here then, dependent on the development of 323

an effective and safe vaccine, immunisation of pregnant women against Group B strep could be the 324

next major breakthrough in the prevention of neonatal sepsis and meningitis. 325

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20. Patten, S., et al., Vaccination for Group B Streptococcus during pregnancy: attitudes

and concerns of women and health care providers. Soc Sci Med, 2006. 63(2): p. 347-

58.

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Table 1: Survey questions and possible responses

Question

Possible responses

1. Which one of the following statements best

describes your current situation?

a) I have one or more children and don’t plan

to have any more

b) I have one or more children and plan to have more

c) I am / my partner is currently pregnant

d) I don’t have any children now, but hope to have one or more children in the future

e) I don’t have any children and don’t expect

to in the future

2. How familiar are you with the following

conditions?


babies



new-born babies

a) I have never heard of it

b) I have heard of it, but I don’t know what it

is

c) I have heard of it, and I know what it is

d) I know what it is, and I have been affected

by it directly

3. How serious do you think the following conditions

are?

• Heavy bleeding in pregnancy (for mother or new-

born child)


babies



new-born babies

a) Very serious

b) Fairly serious

c) Not very serious

d) Not serious at all e) Don’t know

4. How likely or unlikely would you be willing to

receive the following vaccines during pregnancy?

• Vaccine against whooping cough (Pertussis)

• Vaccine against influenza

• Vaccine against Group B Strep infection

a) Very likely

b) Fairly likely

c) Fairly unlikely

d) Very unlikely

e) Don’t know

Information provided about Group B strep

Group B Strep is the UK's most common cause of meningitis and life-threatening infection in newborn babies.

About 20% of UK women carry Group B Strep bacteria without having any symptoms. Babies can be exposed at

birth and afterwards from the mother and from other sources. Most will not develop infection but about 600—700

babies a year in the UK do. Currently, antibiotics can be given during labour if the mother is considered to be at high risk of having a baby with Group B Strep infection, but this does not prevent all infections.

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A vaccine for pregnant women to protect their babies against Group B Strep is being developed. This vaccine has so

far been given to many adults and to a small number of pregnant women in research studies. These studies have

found no evidence of harm to the women or their unborn babies and the results suggest than the vaccine could

prevent most Group B Strep infections in babies.

5. After reading the description above, how likely or

unlikely would you be willing to receive a vaccine

against Group B Strep during pregnancy?

a) Very likely

b) Fairly likely

c) Fairly unlikely

d) Very unlikely e) Don’t know

6. Could you explain why you would be likely/

unlikely to be willing to receive a vaccine against

Group B Strep during pregnancy?

a) __________________

b) I prefer not to say

7. Specifically, how likely or unlikely would you be

willing to receive a Group B Strep vaccine during

pregnancy in each of the following situations?


vaccine protects infants against Group B Strep,

before the vaccine is licensed (approved for routine use in pregnancy) if the vaccine had been given to

500 pregnant women without significant safety

concerns


vaccine protects infants against Group B Strep, before the vaccine is licensed (approved for routine

use in pregnancy) if the vaccine had been given to

5000 pregnant women without any significant safety concerns

• If the vaccine was licensed (approved for use), but

not specifically recommended for routine use by the

NHS

• If the vaccine was licensed and recommended for

routine use by the NHS

a) Very likely

b) Fairly likely c) Fairly unlikely

d) Very unlikely

e) Don’t know

8. Please indicate how important, or otherwise, you

would consider the advice of each of the following

in making a decision as to whether or not you

would be comfortable to receive (or for your

partner to receive) a Group B Strep vaccine

during pregnancy.

• Partner

• A midwife

• An obstetrician

• Your GP

• Written hand-outs provided by the NHS

• Information on the internet, e.g. parent forums

• The media

• Friends and family

• Other

• Very important

• Fairly important

• Not very important

• Not at all important

• Don’t know

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How serious would you

consider the following

conditions?

18-

24yrs

(% of

n= 239)

25-

34yrs

(% of

n=359)

35-

44yrs

(% of

n=415)

p- value

Children

(% of n=

570)

No

children

(% of

n=443)

p-value

Know

what it is

(% of

n**)

Don’t

know what

it is

(% of n**)

p- value

Heavy

bleeding in

pregnancy

Serious 91 94 96 0.03 96 91 0.0011

Don’t

know

5 5 4 2 7

Not

serious

4 1 0 0.002 1 2 NS

Pertussis Serious 82 86 94 <0.0001 92 83 <0.0001 92 79 <0.0001

Don’t

know

11 9 5 5 12 4 18

Not

serious

6 4 1 0.003 3 5 NS 4 3 NS

Influenza Serious 81 80 85 NS 85 80 NS 88 74 <0.0001

Don’t

know

14 12 8 8 16

5 21

Not

serious

5 8 6 NS 8 4 0.0268

7 5 NS

Group B

strep

Serious 72 75 86 <0.0001 84 72 <0.0001 92 71 <0.0001

Don’t

know

21 20 12 12 24 4 26

Not serious

7 4 1 0.0014 3 4 NS 5 3 NS


to have a vaccine for the

following conditions in

pregnancy?

18-

24yrs

(% of

n= 239)

25-

34yrs

(% of

n=359)

35-

44yrs

(% of

n=415)

p- value

Children

(% of n=

570)

No

children

(% of

n=443)

p-value

Know

what it is

(% of

n**)

Don’t

know what

it is

(% of n**)

p- value

Pertussis Likely 75 76 72 NS 79 70 0.0018 77 67 0.0013

Don’t

know

18 15 19 12 23 44 25

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Influenza Likely 73 72 70 NS 75 68 0.0211 76 65 0.0002

Don’t

know

18 16 18 12 23

11 26

Unlikely 9 12 12 NS 13 9 0.0437 12 9 NS

Group B

strep (pre

information)

Likely 72 72 72 NS 77 65 <0.0001 79 67 <0.0001

Don’t know

22 19 20 14 28 11 25


Group B

strep (post

information)

Likely 80 81 85 NS 86 77 <0.0001 86 80 0.0217

Don’t know

13 11 10 7 16 7 14


Table 2: Survey responses by age, parental status and previous knowledge of the condition. Answers were mutually exclusive and p values indicate

differences between groups for that answer versus all other answers. NS = non-significant i.e. p>0.05. Percentages are rounded to nearest whole number.

*Respondents self-defined whether they had been directly affected, therefore this does not necessarily refer to their own children.

** Know what it is: pertussis n=727, flu n=609, Group B strep n=374. Don’t know what it is: n=286, flu n=404, Group B strep n=639

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Group

Pre info (%)

Post info (%) p-value

18-24yrs (n= 239) 185 (72) 208 (80) 0.0236

25-34yrs (n=359)

255 (72)

289 (81) 0.0038

35-44yrs (n=415)

286 (72)

337 (85) <0.0001

Children (n= 557)

428 (77)

481 (86) <0.0001

No children (n=456)

297 (65)

352 (77) <0.0001

Prior Knowledge

(n=374)

297 (79)

321 (86) 0.0262

No prior knowledge

(n=639)

429 (67) 512 (80) <0.0001

Table 3: Effect of providing information about Group B strep (see table 1) on likelihood of being willing to receive a Group B strep vaccine in pregnancy

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to have a Group B strep

vaccine in the following

situations?

18-

24yrs

(% of

n=239)

25-

34yrs

(% of

n=359)

35-

44yrs

(% of

n=415)

p- value Children

(% of

n=557)

No

children

(% of

n=456)

p-value Know

what it is

(% of

n=374)

Don’t

know what

it is

(% of

n=639)

p- value

Licensed and

recommended

Likely 78 79 80 NS 81 76 NS 83 77 0.0163

Don’t know

15 12 14 11 16 10 16


Licensed, not

specifically

recommended

Likely 56 52 50 NS 52 52 NS 57 49 0.0132

Don’t

know

17 19 21 18 21 16 21

Unlikely 27 29 29 NS 30 27 NS 27 30 NS

Part of a

research study,

previously

tested in 5000

pregnant

women

Likely 50 44 38 0.0139 46 40 NS 47 41 NS

Don’t

know

19 15 21 16 21 16 20

Unlikely 31 40 41 0.0247

38 38 NS 38 38 0.0246

Research

study,

previously

tested in 500

pregnant

women

Likely 34 35 28 NS 37 27 0.0009 36 30 0.0435

Don’t

know

21 17 24 19 23 18 23

Unlikely 45 48 47 NS 44 50 NS 46 47 NS

Table 4: Likelihood of accepting Group B strep vaccine in four difference scenarios by age, parental status and previous knowledge of Group B strep. Answers were mutually exclusive and p values indicate differences between groups for that answer versus all other answers. NS = non-significant i.e. p>0.05.

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Figure 1: Distribution of respondents by parental status. N=1013 women aged 18-44 years. 209x297mm (300 x 300 DPI)

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Figure 2: The important of advice from various sources of information when making decisions on antenatal vaccination

297x209mm (300 x 300 DPI)

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1

STROBE Statement—checklist of items that should be included in reports of observational studies

Item

No Recommendation

Title and abstract 1 (a) Indicate the study’s design with a commonly used term in the title or the abstract

The phrase “A survey” has been included in the title to indicate the design (title

page 1)

(b) Provide in the abstract an informative and balanced summary of what was done

and what was found

The abstract can be found on page 4

Introduction

Background/rationale 2 Explain the scientific background and rationale for the investigation being reported

This is explained on page 6: Introduction

Objectives 3 State specific objectives, including any prespecified hypotheses

The objectives are stated in the last paragraph of the introduction on page 6

Methods

Study design 4 Present key elements of study design early in the paper

The design in discussed in the methods section, page 6-8 and the survey itself in

table 1

Setting 5 Describe the setting, locations, and relevant dates, including periods of recruitment,

exposure, follow-up, and data collection

Described in methods section, page 6-8,

Setting/location: Online survey sent to women of child bearing age throughout

Scotland, England and Wales

Recruitment: 13-17 September 2013

Exposure: N/A

Follow up: One off survey

Data collection: Online by Comres market research company

Participants 6 (a) Cohort study—Give the eligibility criteria, and the sources and methods of

selection of participants. Describe methods of follow-up

Case-control study—Give the eligibility criteria, and the sources and methods of case

ascertainment and control selection. Give the rationale for the choice of cases and

controls

Cross-sectional study—Give the eligibility criteria, and the sources and methods of

selection of participants

Details are given in paragraph 2 and 3 of the methods and paragraph 1 of the

results. Further demographic information is given in results section, paragraph

1 (page 8), figure 1 and table 2.

(b) Cohort study—For matched studies, give matching criteria and number of

exposed and unexposed

Case-control study—For matched studies, give matching criteria and the number of

controls per case

N/A

Variables 7 Clearly define all outcomes, exposures, predictors, potential confounders, and effect

modifiers. Give diagnostic criteria, if applicable

Not fully applicable for this study (see cover letter). All respondents were given

the same extra information during the survey (table 1). Potential

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2

confounders/other variables are discussed throughout the results section and the

discussion.

Data sources/

measurement

8* For each variable of interest, give sources of data and details of methods of

assessment (measurement). Describe comparability of assessment methods if there is

more than one group

All data was supplied through the online survey, details are described in

methods paragraph 3-5 (page 8-9)

Bias 9 Describe any efforts to address potential sources of bias

The potential for bias (e.g. that respondents to the survey may be more inclined

to participate in research in general) is discussed in the discussion, paragraph 4

(page 14). Weighting was applied to ensure a nationally representative sample.

Study size 10 Explain how the study size was arrived at

A sample size of 1000 was judged to be sufficient give a nationally representative

view on the issues with the available funding.

Quantitative variables 11 Explain how quantitative variables were handled in the analyses. If applicable,

describe which groupings were chosen and why

Analysis is discussed in methods section paragraph 4 (page 7) and throughout

the results and discussion

Statistical methods 12 (a) Describe all statistical methods, including those used to control for confounding


(b) Describe any methods used to examine subgroups and interactions


(c) Explain how missing data were addressed

Details are given in results paragraph 1, page 8

(d) Cohort study—If applicable, explain how loss to follow-up was addressed

Case-control study—If applicable, explain how matching of cases and controls was

addressed

Cross-sectional study—If applicable, describe analytical methods taking account of

sampling strategy

N/A

(e) Describe any sensitivity analyses

Continued on next page

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3

Results

Participants 13* (a) Report numbers of individuals at each stage of study—eg numbers potentially eligible,

examined for eligibility, confirmed eligible, included in the study, completing follow-up, and

analysed


(b) Give reasons for non-participation at each stage N/A

(c) Consider use of a flow diagram N/A

Descriptive

data

14* (a) Give characteristics of study participants (eg demographic, clinical, social) and information

on exposures and potential confounders

Given in results section paragraph 1 (page 8) , figure 1 and table 2

(b) Indicate number of participants with missing data for each variable of interest


(c) Cohort study—Summarise follow-up time (eg, average and total amount)

N/A

Outcome data 15* Cohort study—Report numbers of outcome events or summary measures over time

Case-control study—Report numbers in each exposure category, or summary measures of

exposure

Cross-sectional study—Report numbers of outcome events or summary measures

All relevant results are reported in the results section and tables 2-4, figure 1-2

Main results 16 (a) Give unadjusted estimates and, if applicable, confounder-adjusted estimates and their

precision (eg, 95% confidence interval). Make clear which confounders were adjusted for and

why they were included

N/A

(b) Report category boundaries when continuous variables were categorized

Tables 2-4

(c) If relevant, consider translating estimates of relative risk into absolute risk for a meaningful

time period

N/A

Other analyses 17 Report other analyses done—eg analyses of subgroups and interactions, and sensitivity

analyses

N/A

Discussion

Key results 18 Summarise key results with reference to study objectives


Limitations 19 Discuss limitations of the study, taking into account sources of potential bias or imprecision.

Discuss both direction and magnitude of any potential bias


Interpretation 20 Give a cautious overall interpretation of results considering objectives, limitations, multiplicity

of analyses, results from similar studies, and other relevant evidence

Discussed throughout the discussion section, pages 12-14

Generalisability 21 Discuss the generalisability (external validity) of the study results

Discussed throughout discussion pages 12-14

Other information

Funding 22 Give the source of funding and the role of the funders for the present study and, if applicable,

for the original study on which the present article is based

Funding from Meningitis Now, on title page 2

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4

*Give information separately for cases and controls in case-control studies and, if applicable, for exposed and

unexposed groups in cohort and cross-sectional studies.

Note: An Explanation and Elaboration article discusses each checklist item and gives methodological background and

published examples of transparent reporting. The STROBE checklist is best used in conjunction with this article (freely

available on the Web sites of PLoS Medicine at http://www.plosmedicine.org/, Annals of Internal Medicine at

http://www.annals.org/, and Epidemiology at http://www.epidem.com/). Information on the STROBE Initiative is

available at www.strobe-statement.org.

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