Lisa Dyson

Breastfeeding promotion for infants in neonatal units: a systematic review and economic analysis

OBJECTIVES To evaluate the effectiveness and cost-effectiveness of interventions that promote or inhibit breastfeeding or feeding with breastmilk for infants admitted to neonatal units, and to identify an agenda for future research. DATA SOURCES Electronic databases were searched (including MEDLINE and MEDLINE In-Process Citations, EMBASE, CINAHL, Maternity and Infant Care, PsycINFO, British Nursing Index and Archive, Health Management Information Consortium, Cochrane Central Register of Controlled Trials, Science Citation Index, Pascal, Latin American and Caribbean Health Sciences, MetaRegister of Controlled Trials, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effectiveness, Health Technology Assessment Database, National Research Register) from inception to February 2008. Advisors identified further published or unpublished material. REVIEW METHODS All papers fulfilled eligibility criteria covering participants, interventions, study design and outcomes. Results from primary studies were assessed and summarised in a qualitative synthesis for each type of intervention and across types of intervention. To estimate long-term cost utility, a decision tree was developed to synthesise data on enhanced staff contact, breastmilk effectiveness, incidence of necrotising enterocolitis (NEC) and sepsis, resource use, survival and utilities. RESULTS Forty-eight studies met the selection criteria for the effectiveness review, of which 65% (31/48) were RCTs, and 17% (8/48) were conducted in the UK. Seven were rated as good quality and 28 as moderate quality. No studies met the selection criteria for the health economics review. There is strong evidence that short periods of kangaroo skin-to-skin contact increased the duration of any breastfeeding for 1 month after discharge [risk ratio (RR) 4.76, 95% confidence interval (CI) 1.19 to 19.10] and for more than 6 weeks (RR 1.95, 95% CI 1.03 to 3.70) among clinically stable infants in industrialised settings. There is strong evidence for the effectiveness of peer support at home (in Manila) for mothers of term, low birthweight infants on any breastfeeding up to 24 weeks (RR 2.18, 95% CI 1.45 to 3.29) and exclusive breastfeeding from birth to 6 months (RR 65.94, 95% CI 4.12 to 1055.70), and for the effectiveness of peer support in hospital and at home for mothers of infants in Special Care Baby Units on providing any breastmilk at 12 weeks [odds ratio (OR) 2.81, 95% CI 1.11 to 7.14; p = 0.01]. There is more limited evidence for the effectiveness of skilled professional support in a US Neonatal Intensive Care Unit on infants receiving any breastmilk at discharge (OR 2.0, 95% CI 1.2 to 3.2, p = 0.004). Multidisciplinary staff training may increase knowledge and can increase initiation rates and duration of breastfeeding, although evidence is limited. Lack of staff training is an important barrier to implementation of effective interventions. Baby Friendly accreditation of the associated maternity hospital results in improvements in several breastfeeding-related outcomes for infants in neonatal units. Limited evidence suggests that cup feeding (versus bottle feeding) may increase breastfeeding at discharge and reduce the frequency of oxygen desaturation. Breastmilk expression using simultaneous pumping with an electric pump has advantages in the first 2 weeks. Pharmaceutical galactagogues have little benefit among mothers who have recently given birth. Our economic analysis found that additional skilled professional support in hospital was more effective and less costly (due to reduced neonatal illness) than normal staff contact. Additional support ranged from 0.009 quality-adjusted life-years (QALYs) to 0.251 QALYs more beneficial per infant and ranged from 66 pounds to 586 pounds cheaper per infant across the birthweight subpopulations. Donor milk would become cost-effective given improved mechanisms for its provision. CONCLUSIONS Despite the limitations of the evidence base, kangaroo skin-to-skin contact, peer support, simultaneous breastmilk pumping, multidisciplinary staff training and the Baby Friendly accreditation of the associated maternity hospital have been shown to be effective, and skilled support from trained staff in hospital has been shown to be potentially cost-effective. All these point to future research priorities. Many of these interventions inter-relate: it is unlikely that specific clinical interventions will be effective if used alone. There is a need for national surveillance of feeding, health and cost outcomes for infants and mothers in neonatal units; to assist this goal, we propose consensus definitions of the initiation and duration of breastfeeding/breastmilk feeding with specific reference to infants admitted to neonatal units and their mothers.

The opportunities and challenges of pragmatic point-of-care randomised trials using routinely collected electronic records: Evaluations of two exemplar trials

BACKGROUND Pragmatic trials compare the effects of different decisions in usual clinical practice. OBJECTIVES To develop and evaluate methods to implement simple pragmatic trials using routinely collected electronic health records (EHRs) and recruiting patients at the point of care; to identify the barriers and facilitators for general practitioners (GPs) and patients and the experiences of trial participants. DESIGN Two exemplar randomised trials (Retropro and eLung) with qualitative evaluations. SETTING Four hundred and fifty-nine English and Scottish general practices contributing EHRs to a research database, of which 17 participated in the trials. PARTICIPANTS Retropro aimed to recruit 300 patients with hypercholesterolaemia and high cardiovascular risk and eLung aimed to recruit 150 patients with a chronic obstructive pulmonary disease exacerbation. INTERVENTIONS Retropro randomised between simvastatin and atorvastatin and eLung between immediate antibiotics and deferred or non-use. eLung recruited during an unscheduled consultation using EHR flagging. MAIN OUTCOME MEASURE Successful trial completion with implementation of information technology (IT) system for flagging and data processing and documentation of operational and scientific experiences. DATA SOURCES EHR research database. RESULTS The governance approval process took over 3 years. A total of 58.8% of the practices (n = 270) expressed interest in participating. The number of interested practices dropped substantially with each stage of the governance process. In Retropro, 6.5% of the practices (n = 30) were eventually approved and 3.7% (n = 17) recruited patients; in eLung, these numbers were 6.8% (n = 31) and 1.3% (n = 6) respectively. Retropro successfully completed recruitment (301 patients) whereas eLung recruited 31 patients. Retropro recruited 20.6% of all statin starters in recruiting practices and 1.1% in the EHR database; the comparable numbers for eLung were 32.3% and 0.9% respectively. The IT system allowed for complex eligibility criteria with central on and off control of recruitment and flagging at a practice. Good Clinical Practice guidelines, governance and consent procedures were found to have substantially affected the intended simple nature of the trials. One qualitative study of 13 clinicians found that clinicians were generally positive about the principle of computerised trial recruitment (flagging during consultation). However, trials which did not include patients with acute illness were favoured. The second qualitative process evaluation interviewed 27 GPs about their actual experiences, including declining, recruiting and non-recruiting GPs. Opportunistic patient recruitment during a routine GP consultation was found to be the most controversial element. The actual experiences of recruiting patients during unscheduled consultation were generally more positive than the hypothetical views of GPs. Several of the recruiting GPs reported the process took 5 minutes and was straightforward and feasible on most occasions. Almost all GPs expressed their strong support for the use of EHRs for trials. Ten eLung participants were interviewed, all of whom considered it acceptable to be recruited during a consultation and to use EHRs for trials. CONCLUSIONS EHR point-of-care trials are feasible, although the recruitment of clinicians is a major challenge owing to the complexity of trial approvals. These trials will provide substantial evidence on clinical effectiveness only if trial interventions and participating clinicians and patients are typical of usual clinical care and trials are simple to initiate and conduct. Recommendations for research include the development of evidence and implementation of risk proportionality in trial governance and conduct. TRIAL REGISTRATION Current Controlled Trials ISRCTN33113202 and ISRCTN72035428. FUNDING This project was funded by the NIHR Health Technology Assessment programme and the Wellcome Trust and will be published in full in Health Technology Assessment; Vol. 18, No. 43. See the NIHR Journals Library website for further project information.

Breastfeeding promotion for infants in neonatal units: a systematic review

BACKGROUND Breastfeeding/breastmilk feeding of infants in neonatal units is vital to the preservation of short- and long-term health, but rates are very low in many neonatal units internationally. The aim of this review was to evaluate the effectiveness of clinical, public health and health promotion interventions that may promote or inhibit breastfeeding/breastmilk feeding for infants admitted to neonatal units. METHODS Systematic review with narrative synthesis. Studies were identified from structured searches of 19 electronic databases from inception to February 2008; hand searching of bibliographies; Advisory Group members helped identify additional sources. INCLUSION CRITERIA controlled studies of interventions intended to increase breastfeeding/feeding with breastmilk that reported breastmilk feeding outcomes and included infants admitted to neonatal units, their mothers, families and caregivers. Data were extracted and appraised for quality using standard processes. Study selection, data extraction and quality assessment were independently checked. Study heterogeneity prevented meta-analysis. RESULTS Forty-eight studies were identified, mainly measuring short-term outcomes of single interventions in stable infants. We report here a sub-set of 21 studies addressing interventions tested in at least one good-quality or more than one moderate-quality study. Effective interventions identified included kangaroo skin-to-skin contact, simultaneous milk expression, peer support in hospital and community, multidisciplinary staff training, and Unicef Baby Friendly accreditation of the associated maternity hospital. CONCLUSIONS Breastfeeding/breastmilk feeding is promoted by close, continuing skin-to-skin contact between mother and infant, effective breastmilk expression, peer support in hospital and community, and staff training. Evidence gaps include health outcomes and costs of intervening with less clinically stable infants, and maternal health and well-being. Effects of public health and policy interventions and the organization of neonatal services remain unclear. Infant feeding in neonatal units should be included in public health surveillance and policy development; relevant definitions are proposed.

Predicting breastfeeding in women living in areas of economic hardship: Explanatory role of the theory of planned behaviour.

This study employed the theory of planned behaviour (TPB) and additional variables (descriptive norm, moral norm, self-identity) to investigate the factors underlying breastfeeding intention and subsequent breastfeeding at four time points (during hospital stay, at hospital discharge, 10 days postpartum and 6 weeks postpartum) in a sample of women selected from defined areas of economic hardship (N = 248). A model containing the TPB, additional variables and demographic factors provided a good prediction of both intention (R 2 = 0.72; attitude, perceived behavioural control, moral norm and self-identity significant predictors) and behaviour – breastfeeding at birth (88.6% correctly classified; household deprivation, intention, attitude significant), at discharge from hospital (87.3% correctly classified; intention, attitude significant), 10 days after discharge (83.1% correctly classified; education, intention, attitude, descriptive norm significant) and 6 weeks after discharge (78.0% correctly classified; age, household deprivation, ethnicity, moral norm significant). Implications for interventions are discussed, such as the potential usefulness of targeting descriptive norms, moral norms and perceived behavioural control (PBC) when attempting to increase breastfeeding uptake.

Policy and public health recommendations to promote the initiation and duration of breast-feeding in developed country settings

OBJECTIVE To develop policy and public health recommendations for implementation at all levels by individuals and organisations working in, or related to, the field of breast-feeding promotion in developed country settings, where breast-feeding rates remain low. DESIGN Two research phases, comprising (i) an assessment of the formal evidence base in developed country settings and (ii) a consultation with UK-based practitioners, service managers and commissioners, and representatives of service users. The evidence base included three systematic reviews and an Evidence Briefing. One hundred and ten studies evaluating an intervention in developed country settings were assessed for quality and awarded an overall quality rating. Studies with a poor quality rating were excluded. The resulting seventy studies examined twenty-five types of intervention for breast-feeding promotion. These formed the basis of the second consultation phase to develop the evidence-based interventions into recommendations for practice, which comprised (i) pilot consultation, (ii) electronic consultation, (iii) fieldwork meetings and (iv) workshops. Draft findings were synthesised for two rounds of stakeholder review conducted by the National Institute for Health and Clinical Excellence. RESULTS Twenty-five recommendations emerged within three complementary and necessary categories, i.e. public health policy, mainstream clinical practice and local interventions. CONCLUSIONS The need for national policy directives was clearly identified as a priority to address many of the barriers experienced by practitioners when trying to work across sectors, organisations and professional groups. Routine implementation of the WHO/UNICEF Baby Friendly Initiative across hospital and community services was recommended as core to breast-feeding promotion in the UK. A local mix of complementary interventions is also required.

Using an extended theory of planned behaviour to inform interventions aimed at increasing breastfeeding uptake in primiparas experiencing material deprivation

OBJECTIVES The theory of planned behaviour (TPB) was employed to investigate infant feeding intentions and subsequent behaviour in women from selected areas of economic hardship in the UK. Underlying beliefs were examined in order to inform future interventions aimed at increasing breastfeeding uptake among women living in such areas, which is associated with low rates of breastfeeding. DESIGN Midwives recruited women from areas meeting study criteria. TPB measures were obtained from 303 primiparas via postal questionnaires completed during pregnancy, and feeding method was subsequently obtained from 286 of these women. RESULTS A model containing age, education, deprivation, attitude, subjective norm (SN), and perceived behavioural control (PBC) predicted intention to breastfeed (R(2)=.44) and intention to formula feed (R(2)=.45). A model controlling for age, education and deprivation predicted ever having breastfed (86.1% correctly classified) and ever having formula fed (77.1% correctly classified). MANCOVAs differentiated those who intended to breastfeed and subsequently did (inclined actors), those who intended to breastfeed but did not (inclined abstainers), and those who did not intend to breastfeed and did not (disinclined abstainers). Differentiating outcome beliefs, normative beliefs, and control beliefs are presented. CONCLUSIONS The TPB provided a useful framework with which to examine the factors underlying breastfeeding intentions and behaviour amongst primiparas. A grouping system based on the congruence between intentions and subsequent behaviour revealed important differences between beliefs of the three groups. Further research might usefully test the effectiveness of interventions targeting the beliefs identified here in increasing breastfeeding uptake and duration.

Rethinking research in breast-feeding: a critique of the evidence base identified in a systematic review of interventions to promote and support breast-feeding

OBJECTIVE To appraise critically the relevance and value of the evidence base to promote and support the duration of breast-feeding, with a specific focus on disadvantaged groups. DESIGN A systematic review was conducted of intervention studies relevant to enhancing the duration of breast-feeding; topics included public health, public policy, clinical issues, and education, training and practice change. A systematic search was conducted. Eighty studies met the inclusion criteria. Data were systematically extracted and analysed. Full results and recommendations are reported elsewhere. Here a critique of the evidence base--topics, quality and gaps--is reported. RESULTS Many studies were substantially methodologically flawed, with problems including small sample sizes, inconsistent definitions of breast-feeding and lack of appropriate outcomes. Few were based on relevant theory. Only a small number of included studies (10%) were conducted in the UK. Very few targeted disadvantaged subgroups of women. No studies of policy initiatives or of community interventions were identified. There were virtually no robust studies of interventions to prevent and treat common clinical problems, or of strategies related to womens health issues. Studies of health professional education and practice change were limited. Cost-effectiveness studies were rare. CONCLUSIONS Policy goals both in the UK and internationally support exclusive breast-feeding until 6 months of age. The evidence base to enable women to continue to breast-feed needs to be strengthened to include robust evaluations of policies and practices related to breast-feeding; a step change is needed in the quality and quantity of research funded.

Maternal obesity: consequences for children, challenges for clinicians and carers

In many industrialised countries almost one in five pregnant women is obese. Maternal obesity has major implications for the fetus and newborn infants, and may have adverse consequences for lifelong health and well-being. We discuss the current epidemiological evidence for the association of maternal obesity with congenital structural neural tube and cardiac defects, fetal macrosomia that predisposes infants to birth injuries and to problems with physiological and metabolic transition, as well as potential for long-term effects secondary to prenatal and neonatal programming effects compounded by a reduction in sustained breastfeeding. We summarise the evidence for the effect of maternal weight management interventions on fetal and neonatal outcomes and discuss areas where further research is needed to clarify uncertainties.

Developing evidence-based recommendations in public health--incorporating the views of practitioners, service users and user representatives.

Background Guidance based on a systematic assessment of the evidence base has become a fundamental tool in the cycle of evidence‐based practice and policy internationally. The process of moving from the formal evidence base derived from research studies to the formation and agreement of recommendations is however acknowledged to be problematic, especially in public health; and the involvement of practitioners, service commissioners and service users in that process is both important and methodologically challenging.

Breastfeeding for longer: what works?

This summary paper gives an overview of key findings from a series of systematic reviews of studies of interventions relevant to the continuation of breastfeeding, together with recommendations for practice and policy. It is relevant to all those who work with women in pregnancy and with breastfeeding women; practitioners and policy makers in public health; and those in acute and community maternal and infant services. The full report will be available on the HDA website in late 2004. The next stage of this work is to develop detailed guidance for practice.