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Abstract
Objective To explore the influencing factors and reasoning of parents who opt out of intramuscular vitamin K prophylaxis for their newborn.
Design We conducted a qualitative study with 15 families from the Otago/Southland region of New Zealand. Semistructured interviews explored their choice to opt out of intramuscular vitamin K prophylaxis and thematic analysis was used to elucidate themes that captured important aspects of this parental decision-making process.
Results Parents opt out of intramuscular vitamin K for a variety of reasons. These were clustered into three main themes: parents' beliefs and values (philosophy and spirituality), concerns about their child's welfare (pain and potential side effects) and external influencing factors (family, friends, media and health professionals). As part of a wider family hesitancy towards medical intervention, the majority of parents also raised concerns regarding other perinatal or childhood interventions.
Conclusion Many factors influence parental decision making and lead to a decision to opt out of newborn intramuscular vitamin K prophylaxis. Due to strong parallels with other common childhood interventions, these findings have relevance for vitamin K prophylaxis and for other healthcare interventions in childhood.
- Blood
- Children
- Clinical Ethics
- Decision-making
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Introduction
Disagreements between parents and health professionals in the context of a child's medical treatment represent some of the most challenging issues in clinical paediatrics and feature significantly in the paediatric bioethics literature. There is a substantial body of work exploring this parental hesitancy, including in relation to declining blood products by Jehovah's Witness parents;1 immunisation2 and newborn screening (NBS).3 Interestingly, one of the very first healthcare interventions recommended in infancy, administration of vitamin K prophylaxis at birth to prevent vitamin K deficiency bleeding (VKDB), has received relatively little attention.
Infants are born with relatively low stores of vitamin K, which places them at risk of VKDB. Depending on the pattern of onset, VKDB is classified into three categories: early VKDB, which occurs in the first 24 hours of life and is typically seen in the infants of mothers taking drugs that interfere with vitamin K metabolism; classical VKDB, which occurs from 24 hours to 7 days of age; and late VKDB, which occurs between 8 days and 6 months of life.4 VKDB most commonly presents as relatively mild gastrointestinal or mucocutaneous bleeding;5 ,6 however, intracranial haemorrhage occurs in 50%–80% of infants with late VKDB and thus can result in death or permanent neuro-disability.4 ,7 As a result, many countries have introduced guidelines that recommend administration of vitamin K to every baby soon after birth.
An intramuscular route is generally preferred over multiple oral doses partly because of concerns of reliability of administration and efficacy.8 In New Zealand (NZ), the Ministry of Health recommends that all babies should receive vitamin K prophylaxis.9 The recommended route of administration is 1 mg intramuscularly at birth or preterm infants may receive 0.5 mg. Parents give verbal and written consent for their child to receive this. The vitamin K used in NZ is Konakion MM (2 mg/0.2 mL). If parents do not agree to an intramuscular injection, the alternative is for the infant to receive Konakion MM (the same preparation), 2 mg orally at birth. The infant should then also receive a repeat 2 mg oral dose at 3–5 days and another dose at 4–6 weeks of age.9
In the presence of intramuscular vitamin K prophylaxis, VKDB is rarely seen with an incidence of approximately 1/100 000 live births, as opposed to rates of 1/1500 or more in the absence of prophylaxis.7 ,10 A NZ surveillance study found that when VKDB does occur, it is almost invariably in children for whom vitamin K has been omitted through error or because their parents withheld consent.7
Recent studies have documented factors associated with declining vitamin K uptake, including mode of delivery (vaginal birth, no medical intervention, birthing at home or in a birth centre); ethnicity; education (specifically having a higher education level) and the type of health professional involved11–15—specifically a Canadian study found that those with a midwife were more likely to decline intramuscular vitamin K than those with a physician. In NZ, it is an expectation that lead maternity carers (LMCs—the majority of whom are midwives) discuss vitamin K prophylaxis as part of antenatal education. However, another recent study has highlighted differences in attitude between midwifery and medical staff, with 100% of doctors considering that all infants should receive vitamin K prophylaxis compared with 54.7% of midwives.16
Some data already exist regarding why parents choose to opt out of vitamin K prophylaxis. One recent study used a survey to ask parents about their concerns regarding vitamin K and where they got their information from. The most common source of information for parents was the internet and the most common concerns were centred on synthetic or perceived toxic ingredients in the formula, excessive dose and side effects.14 However, no other studies have undertaken in-depth interviews with parents. Understanding parents' reasoning for opting out of intramuscular vitamin K is important as it has an immediate impact in relation to risk of VKDB and may be an early indicator of future uptake for other childhood interventions, such as immunisation.17
This study aimed to explore in more detail the reasoning of a group of parents who declined intramuscular vitamin K prophylaxis for their newborns.
Methods
Study design
Semistructured interviews were used to explore parents' reasons for declining intramuscular vitamin K for their newborn. An interview guide was developed through discussions with paediatricians and neonatologists, as well as pilot interviews with 10 midwives. This ensured that potentially important issues relating to newborn vitamin K were discussed in each interview. Interviews covered basic demographic data including socioeconomic status via a NZ Deprivation Index;18 a description of how the decision to decline intramuscular vitamin K was made; when and how parents first became aware of vitamin K; information sources influencing the decision; specific concerns about giving vitamin K by injection/orally; cultural and religious issues regarding vitamin K prophylaxis; whether parents felt any pressure regarding making their decision; alternative methods employed to prevent VKDB and views about other perinatal health interventions.
Study setting and participants
The study was conducted in the Otago/Southland region of NZ (population ∼310,000). NZ has a publicly funded maternity and newborn care system, with the majority of births for this region occurring at the Queen Mary Maternity Centre (QMMC), Dunedin Hospital (Dunedin, New Zealand) as the provider of tertiary maternity and newborn care for the region. A previous study conducted in the same region found that 7089 babies were born at this centre between January 2009 and December 2012 and, of these, 92.9% of infants received intramuscular vitamin K, 5.4% received oral vitamin K and 1.7% received no prophylaxis.12
The key inclusion criteria were (1) delivery of a live-born child within the Otago/Southland region; (2) decision to decline newborn intramuscular vitamin K for a child (either complete refusal of vitamin K or choice of oral administration and (3) adequate English language knowledge (or availability of an interpreter) for the study interview.
Participants opting out of intramuscular vitamin K were identified prospectively between 7 March 2015 and 18 July 2015 by health professionals at QMMC (six participants); by homebirth midwives based in the Otago area (two participants) and retrospectively via invitation letters posted to mothers who were identified from electronic maternity records as opting out of intramuscular vitamin K between 1 January 2014 and 8 April 2015 at QMMC (three participants from 42 posted) and referrals from other participants (four participants).
Data collection and analysis
Once written informed consent was obtained, an interview was conducted (by the same researcher, HM). The majority of interviews were conducted with the mother and four interviews had both parents present. Interviews generally occurred in participant's homes, although a minority were by phone due to geography and lasted between 15 and 60 min, (median 25 min).
All interviews were digitally recorded and transcribed and then organised using a coding system that reflected the interview guide as well as commonalities noted during analysis. Thematic analysis was then used to sort coded segments of data into themes through an iterative process that included discussion between the research team. Identification of a theme was not necessarily dependent on frequency of use, but rather whether it represented an idea that captured a seemingly important aspect of parental decision making. After 15 interviews, no new themes regularly appeared and after comparing our sample size with that of similar studies, we were confident that our data saturation was adequate to answer the research question.
The study was approved by the New Zealand Health and Disability Ethics Committee (Ethics ref: 12/STH/41).
Results
A total of 15 interviews with families were conducted and demographic data are presented in table 1. Of the 15 families, 8 declined vitamin K with the remainder opting for oral administration. For almost all participants, except for those involved in healthcare themselves, the midwife LMC was their first source of information about vitamin K prophylaxis.
Patient demographics
Inter-related themes and subthemes: (For summary and representative quotes see table 2).
Decision-making themes and subthemes
Parental beliefs and values
Under this category, intramuscular vitamin K was declined due to incompatibilities between parental beliefs or values and vitamin K prophylaxis, including a strong identity with an ‘alternative lifestyle’ and a belief that birth is a natural process, needing little ‘interference’, often based on religious or evolutionary perspectives.
For such families, these beliefs were not limited to their children and guided many aspects of their personal and family lives. None of the families stated any cultural concerns relating to their ethnicity; however, some strongly identified with less ‘mainstream’ approaches to life (quotes 1, 2 and 9).
For another, religion was an additional important aspect of decision making (quote 15).
Child welfare
While parental beliefs and values were important factors for decision making, the majority of parents also spoke of weighing up the risks and benefits of prophylaxis specifically for their child. This often related to a perceived low level of necessity, potential pain related to intramuscular injection or their worry about risks and/or side effects (quotes 16, 17, 23 and 24).
Child welfare issues also work both ways and, for three participants who originally opted out of intramuscular vitamin K, following an instrumental birth, they opted back in. In these instances, the risk:benefit ratio was felt to be altered (quote 27). Furthermore, other participants also spoke of potentially changing their decision if their birth required intervention (quote 28).
For those who opted for oral prophylaxis, perceived pain for their newborn appeared to be a significant factor, provided by the majority as their foremost reason for choosing oral over intramuscular (quotes 21 and 22).
Concerns about side effects or more serious harms were also significant factors for some parents. In the majority, this was a perceived increase in risk for childhood leukaemia (quotes 18 and 19). However, other potential side effects were also of concern, both at the time and in the future (quotes 23 and 24). Additionally, parents' concerns about child welfare could also be based on misinformation (quote 20).
External influences
Parents, other women and a celebrity were mentioned by participants as additional influencing factors. For some participants, knowing of other women who had declined intramuscular vitamin K prophylaxis and had healthy babies made them feel more confident in their decision (quotes 32 and 33).
Health professionals also appear to have an important influencing role. This was reported by multiple families, including encouragement for vitamin K administration (quote 29) and also one midwife sharing a personal opinion that not all infants require vitamin K (quote 30).
Sources of external information both formal (information sheets) and otherwise (internet blogs) were also commented on by parents (quote 31).
Other issues
Participant concerns regarding other healthcare interventions, particularly those for children and pregnant women, were also explored. A number of interventions were additional sources of concern for families, including immunisations, NBS, folic acid supplementation, cord clamping and medicalisation of pregnancy/childbirth. This resulted in 7/15 planning to or already declining immunisation; 2/15 declining newborn metabolic screening as well as 5/15 opting for home birth.
Concerns about immunisation centred on the idea of safety and also not wanting to inject a child.
“I'm just not a huge fan of injecting any child with anything… my first was never immunised” (participant 8).
“I think that with something so little and so new that you know they can have too much at one time and so I'd already considered when the baby is due for vaccinations at six weeks to try and have them spread out” (participant 13).
For NBS, parental beliefs included that it was not necessary:
After a “normal, healthy pregnancy” (participant 4).
“A large amount of it was the trust in the normal…there's always risk in life and they're incredibly low for the diseases that are screened for” (participant 2).
Concerns regarding folic acid related to the idea of mass medication.
“Here we are fortifying foods for the whole population but actually some of us don't need that stuff because we eat food that's got it in it naturally” (participant 4).
Discussion
This study is the first to examine in detail parental reasons for opting out of intramuscular vitamin K, one of the earliest and most prevalent public health interventions, for newborns. Key findings are the identified themes influencing this decision-making process, including underlying parental beliefs and values; concerns about risks/benefits and external influences. Other studies which have also identified these factors are present in the wider medical literature.19 Factors such as a distrust of medicine and scepticism about the available scientific evidence have also been reported in a recent study examining midwifery perceptions of vitamin K prophylaxis16 and for other similar interventions such as immunisation.19 This is also additionally highlighted in our data with high rates of non-immunisation, declining NBS and opting for home birth.
It is also evident that a previously discounted study linking leukaemia to intramuscular vitamin K20 ,21 continues to impact on parental decision making, with many raising concerns about leukaemia, as well as other potential harms. This concern about leukaemia and other harms has also been highlighted among a minority of NZ midwifery professionals,16 thus again showing how harmful, even a refuted study can be. This parallels disproved issues related to measles, mumps and rubella immunisation and autism.22 This controversy resulted in an initial significant drop in immunisation and some parents still continue to report concerns about this perceived link.23 Recent studies have also strengthened the evidence for a link between vitamin K and immunisation, revealing that those declining newborn intramuscular vitamin K prophylaxis are approximately 14 times more likely to subsequently decline immunisation.13 ,17 While it is unclear exactly why this link exists, this study has highlighted a number of commonalities between why parents decline intramuscular vitamin K prophylaxis and why parents decline immunisations. This highlights a potential opportunity to identify parents who are more likely to opt out of immunisations in order to provide them information and counselling regarding this decision.
Parental fears of perceived infant pain also appear to be a strong driver towards opting for the alternative oral vitamin K preparation. This issue has also been seen with regard to paediatric immunisation and NBS.24 ,25 It has been recently speculated that this may be one possible contributing reason for an association linking Asian/Indian ethnicity to uptake of oral vitamin K.12 Interestingly, two of the three participants in our study of Asian/Indian ethnicity, raised this as an issue.
As with immunisation, parental perception of risk appears to have a major bearing on vitamin K uptake, with a number commenting on how small their perception of the risk was and also a (false) perception of the protection a ‘normal’ delivery/pregnancy gives to a child. Supporting this, a range of studies have now associated refusing intramuscular vitamin K with factors aligned with parental or health professional preferences/attitudes towards natural birth.11 ,12 ,16 This highlights the importance of appropriate education of families. Additionally, the language and messages in guidelines and position statements should ideally be consistent for all professional bodies. For instance, in NZ, the official Ministry of Health guideline states that ‘all babies should receive vitamin K prophylaxis and it is the responsibility of the LMC to ensure parents are aware of this recommendation’. In a slight, but important contrast, the New Zealand College of Midwives consensus statement states that ‘midwives should ensure the woman is informed and supported to reach her own decision on whether vitamin K should be given intramuscularly, orally, or not at all’.26 It has been previously postulated that this wording difference may partially account for, as well as reflect, a difference in professional attitudes towards vitamin K prophylaxis between doctors and midwives, with a minority of midwives demonstrating quite negative views.16
External influences were also raised by many parents as having an effect on their decision making, including family pressure and the choices made by other pregnant women within their social circle. For immunisation, these psychosocial factors, as well as media portrayal (including television, newspapers, radio and the internet), have also been shown to have an effect on parental decision making.27 ,28 It should be noted that information provided by the media, particularly the internet, is not necessarily accurate. As shown by our study, this can have an effect on how parents make decisions regarding interventions and illustrates the importance of discussing parents' reasons with them to ensure they are basing their decision on factual, accurate information. Interestingly, in our data, a point of difference from the immunisation literature is that media portrayal does not appear to have had such a large influence on most parents' choices. This may relate to a relative paucity of media reports concerning vitamin K in comparison with immunisation.
The attitudes and values of a family's health professionals are also important influences. Differing opinions between midwifery and medical staff regarding the importance of vitamin K have previously been highlighted16 and our data show that this may result in differences in what health professionals tell parents. Furthermore, a Canadian study found that midwife-assisted deliveries were eight times more likely to be associated with vitamin K refusal compared with physician-attended deliveries.13 However, given the generally high rates of uptake for vitamin K prophylaxis around the world,11–13 it appears that the majority of health professionals, whatever their field of practice, support this intervention. Data on NZ midwives highlight this, with the majority noted to consider that it was important that babies receive a dose of vitamin K.16 However, in order to ensure that all families receive similar information regarding vitamin K prophylaxis, we put forward that it may be beneficial to add a section to vitamin K consent forms currently in use that states that families have been made aware of the MEDSAFE guideline (which is in line with similar international guidelines).
Examining the issue of refusal of intramuscular vitamin K and our interview data through the lens of an ethical framework highlights some additional fundamental issues. First, although it has become widely acceptable to permit parental refusal of vitamin K, there has been little robust discussion of whether or not this is defensible from an ethical perspective. Nowadays there is also an extensive body of literature concerning the circumstances in which a health professional is justified in overriding parents' medical decisions for their children. Most contemporary frameworks permit parental discretion unless there is a significant, imminent risk to the child.29–31 For example the ‘Zone of Parental Discretion’ permits decisions ranging from those which are absolutely optimal for the child's interests to those that do not meet some or all of the child's interests but are not so bad as to constitute probable significant harm to the child.29 The precise level of risk to the child that will be tolerated within such frameworks remains to be determined: interventions such as vitamin K prophylaxis that aim to prevent rare, but potentially very serious effects present significant challenges to these models.
Regardless of these complexities, in clinical practice, refusal of vitamin K currently appears to fall below any threshold for ‘state intervention’. Similar argument have also been made in relation to parental refusal of NBS which carries a broadly comparable level of risk3 (for NBS, although the individual disorders may be very rare, the combined incidence is estimated to be as high as 1:500–1:1000 births with delayed diagnosis resulting in significant morbidity and mortality32). However, if it is ethically acceptable for parents to decline intramuscular vitamin K, it is not clear how health professionals should respond when the baby's treatment then exists within a ‘zone of sub-optimal interests’, at least from a medical perspective. This is particularly pertinent given recent reports of a rise in VKDB due to decreasing uptake of prophylaxis.33 One recently published piece from the USA, where oral vitamin K administration is not routinely offered, discussed how clinicians should act when parents state that they would prefer oral dosage for their child and highlighted the importance of educating parents and explaining the reasoning behind medical recommendations.34
Our interview data may be useful in this regard. For example, if the parents' major concerns relate to child welfare, specific steps may be taken to educate and reassure parents and/or pain management could be further explored. These measures, coupled with an acknowledgement to the parents that their decision, while not optimal from a medical perspective, falls within their decisional discretion, arguably, respect the parents and enable the health practitioner to act in an ethically appropriate and professional manner. Additionally, if the decision to decline intramuscular vitamin K is based on misinformation, it is important that the clinician takes the time to appease any concerns and provide accurate, unbiased information to the parents.
If underlying parental beliefs and values are the major determinant in the decision to opt out of vitamin K, further education concerning child welfare may be less helpful. It is important that such parents do not feel pressured to make a decision contrary to their personal wishes as this may polarise their future attitudes towards healthcare.3 However it is equally important that communication strategies are developed such that health professionals can explain why the parental decision is considered ‘sub-optimal’ from a medical perspective, yet still falls within an ethically acceptable range. In this instance, such conversations may have more relevance to future parental healthcare decision making than to the vitamin K decision. A clear acknowledgement of the moral weight accorded to parents as decision makers for their child, coupled with an understanding that healthcare professionals take potential harm to the child very seriously, may set the scene for future healthcare interventions.
As always with studies of this type, sample size and generalisability are weaknesses, as the research setting is confined to one region in NZ, and while we cannot claim that the results of this study include all possible themes and influencing factors, after 15 interviews no new themes were appearing and we were satisfied that our data saturation was sufficient to answer the research question. In addition, the qualitative methodology is a strength in that it has enabled an initial exploring and highlighting of themes and experiences as well as a detailed analysis of parental reasons for opting out of intramuscular vitamin K prophylaxis. In future, wider inclusion and exploration of these issues will be required and this work could serve as a springboard for additional quantitative research to confirm and/or expand on our findings.
In conclusion, parental refusal of newborn intramuscular vitamin K prophylaxis is an important and topical issue due to rising numbers of parents opting out. It is both one of the first healthcare decisions most families make for their newborn and a potential early indicator of subsequent healthcare decision making. This study has identified, for the first time, factors that influence parental decision making and lead to a decision to opt out of newborn intramuscular vitamin K prophylaxis. Thus, these findings add to our understanding of factors influencing parental choice, contribute to a wider body of literature on newborn interventions and likely have implications for newborn vitamin K prophylaxis and perhaps for how parents make other future healthcare decisions for their child.
References
Footnotes
Contributors All authors were involved in the planning and design of this study. The interviews were conducted by HM and thematic analysis was performed by HM, NK and BJW. Revision of the draft paper was conducted by all authors.
Competing interests None declared.
Ethics approval New Zealand Health and Disability Ethics Committee.
Provenance and peer review Not commissioned; externally peer reviewed.