A new era for intervention development studies

This editorial introduces a new special series on intervention development in the on-line open access journal Pilot and Feasibility Studies.An intervention development study reports the rationale, decision-making processes, methods and findings which occur between the idea or inception of an intervention until it is ready for formal feasibility, pilot or efficacy testing prior to a full trial or evaluation. This editorial begins to explore some of the challenges associated with this early research stage. It commences a debate about how to produce novel interventions which are fit for purpose and which solve important health and social care problems. By transparently reporting more intervention development studies, scientific rigour will be improved and everyone can learn from the experiences of others.  Intervention development can be viewed as a “black box” or the “Cinderella” of complex intervention trial design. This is because important processes and decision-making in the early stages of intervention development are seldom reported and until now, journals have shown little interest in publishing such studies. Intervention development studies exist in small grant reports and PhD chapters and tend to gather dust on the shelf as researchers move on to secure larger grants and new projects. So anecdotally, researchers encounter recurring pitfalls, spend time in blind alleys and worry about intervention decisions, with little guidance available. In addition, until recently, UK research funding institutions have not prioritised investment in complex intervention development.  The importance of methodological rigour at this early stage is recognised [1], and there is research waste from developing interventions that never impact on health care [2]. With ageing populations, multi-morbidity and lifestyle behaviours that seem remarkably resistant to change effective interventions are needed. In this special series, we begin to open the black box of intervention development. We are particularly interested in complex interventions, where there are several interacting components, rather than drugs or invasive devices which have regulated development processes.Output Type: Editoria

Coeliac disease: Non-invasive diagnosis needed

LetterOutput Type: Lette

Step 10: the breastfeeding support paradox

First paragraph: In the cluster randomised controlled trial by Marcel Yotebieng and colleagues (August, 2015)1the addition of Step 10 of the UNICEF Baby Friendly Hospital Initiative (BFHI)—that is, the provision of additional support for breastfeeding—did not enhance the effects of steps 1–9, and may even have lessened them. Consistent findings were reported for a trial of Step 10 in Scotland between 2005 and 2007.2In this large cluster-randomised trial, the BIG (Breastfeeding in Groups) trial, 14 primary care organisations were asked either to set up new breastfeeding support groups to cover their geographical area, or to leave their existing group provision for pregnant and postnatal women unchanged. More than 18 000 babies were followed up and there was no significant difference between the two groups in change from baseline in rates of exclusive, or any, breastfeeding 8 weeks after birth.Output Type: Lette

'Breakfast, lunch and dinner': attitudes to infant feeding amongst children in a Scottish primary school. A qualitative focus group study

Objective  To describe the knowledge, attitudes and beliefs about infant feeding in one primary school in Scotland.  Design Qualitative focus group study.  Setting  A single primary school which serves a mixed socioeconomic area in the north of Scotland.  Method Parents gave demographic details about their family and information about whether their children had been breastfed. Twenty- three children, aged 6, took part in three focus groups which were conducted by two facilitators, according to a predetermined topic guide. Focus group data were supplemented with analyses of children's drawings and with fieldnotes.  Results Children generally spoke of and drew pictures of bottle-feeding. Their lack of everyday language for breastfeeding suggested that breastfeeding was not a'taken-for-granted' activity. The repeated reference to adult meal patterns and to equipment suggested that the children have a mechanistic and confused idea of what breastfeeding involves. Their difficulties conceptualising night feeds and feeding in public places suggested that the children viewed breastfeeding as a private activity, permissible only in certain contexts. Children had vivid recall of TV images of infant feeding.  Conclusions Despite the observation that breastfeeding was not generally perceived as a natural activity, our findings suggest that primary school children are interested in infant feeding and that they can be engaged in and educated about it as young as six years old. Larger studies are needed to further explore attitudes to infant feeding

Process evaluation for the FEeding Support Team (FEST) randomised controlled feasibility trial of proactive and reactive telephone support for breastfeeding women living in disadvantaged areas

OBJECTIVE: To assess the feasibility, acceptability and fidelity of a feeding team intervention with an embedded randomised controlled trial of team-initiated (proactive) and woman-initiated (reactive) telephone support after hospital discharge. DESIGN: Participatory approach to the design and implementation of a pilot trial embedded within a before-and-after study, with mixed-method process evaluation. SETTING: A postnatal ward in Scotland. SAMPLE: Women initiating breast feeding and living in disadvantaged areas. METHODS: Quantitative data: telephone call log and workload diaries. Qualitative data: interviews with women (n=40) with follow-up (n=11) and staff (n=17); ward observations 2 weeks before and after the intervention; recorded telephone calls (n=16) and steering group meetings (n=9); trial case notes (n=69); open question in a telephone interview (n=372). The Framework approach to analysis was applied to mixed-method data. MAIN OUTCOME MEASURES: Quantitative: telephone call characteristics (number, frequency, duration); workload activity. Qualitative: experiences and perspectives of women and staff. RESULTS: A median of eight proactive calls per woman (n=35) with a median duration of 5 min occurred in the 14 days following hospital discharge. Only one of 34 control women initiated a call to the feeding team, with women undervaluing their own needs compared to others, and breast feeding as a reason to call. Proactive calls providing continuity of care increased women's confidence and were highly valued. Data demonstrated intervention fidelity for woman-centred care; however, observing an entire breast feed was not well implemented due to short hospital stays, ward routines and staff-team-woman communication issues. Staff pragmatically recognised that dedicated feeding teams help meet women's breastfeeding support needs in the context of overstretched and variable postnatal services. CONCLUSIONS: Implementing and integrating the FEeding Support Team (FEST) trial within routine postnatal care was feasible and acceptable to women and staff from a research and practice perspective and shows promise for addressing health inequalities

Breastfeeding and risk for ceasing in mothers of preterm infants-long-term follow-up

Breastfeeding is challenging for mothers of preterm infants. The aim of this paper is to describe risk factors for ceasing breastfeeding and methods of feeding until 12 months postnatal age in mothers who breastfed their preterm infants at discharge from neonatal intensive care units (NICUs). The data come from a randomised controlled trial, which evaluated the effectiveness on exclusive breastfeeding at 8 weeks of proactive telephone support compared to reactive support offered to mothers of preterm infants following discharge from NICU. Six NICUs across Sweden randomised a total 493 mothers. We used regression and survival analyses to assess the risk factors for ceasing breastfeeding and the long-term outcomes of the intervention. The results showed that 305 (64%) of the infants were breastfed at six months and 49 (21%) at 12 months. Partial breastfeeding at discharge, low maternal educational level and longer length of stay in the NICU increased the risk for ceasing breastfeeding during the first 12 months. Furthermore, the Kaplan-Meier analysis showed that the proportion of mothers who ceased breastfeeding did not differ between the intervention (n=231) and controls (n=262) during the first 12 months (Log rank test p=0.68). No difference was found between groups on method of feeding. More than 85% of the infants were fed directly at the breast. These findings provide important insights for health professionals who are supporting mothers of preterm infants to breastfeed long-term. Registered in www.clinicaltrials.gov (NCT01806480)

How UK internet websites portray breast milk expression and breast pumps: a qualitative study of content

BackgroundExclusive breastfeeding for six months is recommended but few parents achieve this; particularly younger and less well-educated mothers. Many parents introduce infant formula milk to manage feeding but describe a desire to express breastmilk alongside a lack of support or information. The Internet is highlighted as a key resource. This study aimed to examine UK websites on expressing breastmilk to identify key messages and how information is provided.MethodsWe used search terms in Google to identify websites with information rich content on expressing breastmilk and breast pumps. Ten sites were purposively selected at two time points in 2013 and 2014 to represent 3 categories: commercial, NHS or 3rd sector (voluntary or not for profit). Each site was reviewed by two researchers, data and reflective analytical notes were uploaded into NVivo and thematic data analysis undertaken.ResultsSites varied considerably in their design, use of images, videos, audio files, product placement and marketing opportunities. Three key themes emerged: depiction of expressing; reasons to express; and recommendations about expressing. Inconsistent and conflicting information was common within and between sites. Expressing was portrayed as similar to, but easier than, breastfeeding although at the same time difficult and requiring to be learned. Expressed breastmilk is promoted by mainly commercial sites as immediately available, although pumps were also presented as needing to be concealed, not heard or seen. Health benefits were the overarching reason for expressing. Although predicated on separation from the baby, commercial sites identified this as a positive choice while other sites focused on separation due to circumstance. Commercial sites emphasised restrictions related to breastfeeding, lack of sleep and bonding with the father and wider family. Non-commercial sites emphasised hand expression, with some not mentioning breast pumps. Practical information about starting expressing in relation to infant age or duration of breastfeeding was conflicting.ConclusionsInternet information about expressing breastmilk is inconsistent, incomplete and not evidence informed. The lack of research evidence on the relationship between expressing and feeding outcomes has provided opportunities for commercial companies, which have the potential to further exacerbate observed health inequalities. Access to good quality information based on robust evidence is urgently required

Breast pumps as an incentive for breastfeeding: a mixed methods study of acceptability

Increasing breastfeeding rates would improve maternal and child health, but multiple barriers to breastfeeding persist. Breast pump provision has been used as an incentive for breastfeeding, although effectiveness is unclear. Women's use of breast pumps is increasing and a high proportion of mothers express breastmilk. No research has yet reported women's and health professionals' perspectives on breast pumps as an incentive for breastfeeding. In the Benefits of Incentives for Breastfeeding and Smoking cessation in pregnancy (BIBS) study, mixed methods research explored women's and professionals' views of breast pumps as an incentive for breastfeeding. A survey of health professionals across Scotland and North West England measured agreement with ‘a breast pump costing around£40 provided for free on the NHS’ as an incentive strategy. Qualitative interviews and focus groups were conducted in two UK regions with a total of 68 participants (pregnant women, new mothers, and their significant others and health professionals) and thematic analysis undertaken. The survey of 497 health professionals found net agreement of 67.8% (337/497) with the breast pump incentive strategy, with no predictors of agreement shown by a multiple ordered logistic regression model. Qualitative research found interrelated themes of the ‘appeal and value of breast pumps’, ‘sharing the load’, ‘perceived benefits’, ‘perceived risks’ and issues related to ‘timing’. Qualitative participants expressed mixed views on the acceptability of breast pumps as an incentive for breastfeeding. Understanding the mechanisms of action for pump type, timing and additional support required for effectiveness is required to underpin trials of breast pump provision as an incentive for improving breastfeeding outcomes