Mycophenolate Mofetil for First-Line Treatment of Immune Thrombocytopenia.

BACKGROUND: Immune thrombocytopenia is a rare autoimmune disorder with associated bleeding risk and fatigue. Recommended first-line treatment for immune thrombocytopenia is high-dose glucocorticoids, but side effects, variable responses, and high relapse rates are serious drawbacks. METHODS: In this multicenter, open-label, randomized, controlled trial conducted in the United Kingdom, we assigned adult patients with immune thrombocytopenia, in a 1:1 ratio, to first-line treatment with a glucocorticoid only (standard care) or combined glucocorticoid and mycophenolate mofetil. The primary efficacy outcome was treatment failure, defined as a platelet count of less than 30×109 per liter and initiation of a second-line treatment, assessed in a time-to-event analysis. Secondary outcomes were response rates, side effects, occurrence of bleeding, patient-reported quality-of-life measures, and serious adverse events. RESULTS: A total of 120 patients with immune thrombocytopenia underwent randomization (52.4% male; mean age, 54 years [range 17 to 87]; mean platelet level, 7×109 per liter) and were followed for up to 2 years after beginning trial treatment. The mycophenolate mofetil group had fewer treatment failures than the glucocorticoid-only group (22% [13 of 59 patients] vs. 44% [27 of 61 patients]; hazard ratio, 0.41; range, 0.21 to 0.80; P = 0.008) and greater response (91.5% of patients having platelet counts greater than 100×109 per liter vs. 63.9%; P<0.001). We found no evidence of a difference between the groups in the occurrence of bleeding, rescue treatments, or treatment side effects, including infection. However, patients in the mycophenolate mofetil group reported worse quality-of-life outcomes regarding physical function and fatigue than those in the glucocorticoid-only group. CONCLUSIONS: The addition of mycophenolate mofetil to a glucocorticoid for first-line treatment of immune thrombocytopenia resulted in greater response and a lower risk of refractory or relapsed immune thrombocytopenia, but with somewhat decreased quality of life. (Funded by the U.K. National Institute for Health Research; FLIGHT ClinicalTrials.gov number, NCT03156452; EudraCT number, 2017-001171-23.).

Quantitative impact of frenotomy on breastfeeding: a systematic review and meta-analysis.

BACKGROUND: Symptoms related to infant ankyloglossia/tongue-tie may deter mothers from breastfeeding, yet frenotomy is controversial. METHODS: Databases included PubMed, Embase, CINAHL, PsycINFO, Web of Science, and Google Scholar from 1961-2023. Controlled trials and cohort studies with validated measures of surgical efficacy for breastfeeding outcomes were eligible. Meta-analyses synthesized data with inverse-variance weighting to determine standardized mean differences (SMD) between pre-/postoperative scores. RESULTS: Twenty-one of 1568 screened studies were included. Breastfeeding self-efficacy improved significantly post-frenotomy: medium effect after 5-10 days (SMD 0.60 [95% CI: 0.48, 0.71; P < 0.001]), large effect after 1 month (SMD 0.91 [CI: 0.79, 1.04; P < 0.001]). Nipple pain decreased significantly post-frenotomy: large effect after 5-15 days (SMD -1.10 [CI: -1.49, -0.70; P < 0.001]) and 1 month (SMD -1.23 [CI: -1.79, -0.67; P = 0.002]). Frenotomy had a medium effect on infant gastroesophageal reflux severity at 1-week follow-up (SMD -0.63 [CI: -0.95, -0.31; P = 0.008]), with continued improvement at 1 month (SMD -0.41 [CI: -0.78, -0.05; P = 0.04]). From LATCH scores, breastfeeding quality improved after 5-7 days by a large SMD of 1.28 (CI: 0.56, 2.00; P = 0.01). CONCLUSIONS: Providers should offer frenotomy to improve outcomes in dyads with ankyloglossia-associated breastfeeding difficulties. PROTOCOL REGISTRATION: PROSPERO identifier CRD42022303838 . IMPACT: This systematic review and meta-analysis showed that breastfeeding self-efficacy, maternal pain, infant latch, and infant gastroesophageal reflux significantly improve after frenotomy in mother-infant dyads with breastfeeding difficulties and ankyloglossia. Providers should offer frenotomy to improve breastfeeding outcomes in symptomatic mother-infant dyads who face challenges associated with ankyloglossia.

Adherence to the national guidance on foods and drinks to limit or avoid during pregnancy in England: the PEAR Study.

OBJECTIVE: The National Health Service (NHS) England website provides guidance on foods/drinks to avoid or limit during pregnancy because of microbiological, toxicological or teratogenic hazards. The aims were to determine adherence and whether demographic characteristics were associated with adherence. DESIGN: Cross-sectional study. SETTING: Online survey of postpartum women resident in England during pregnancy. PARTICIPANTS: Recently, postpartum women resident in England during their pregnancy (n 598; median age 33 (IQR 30-36) years) completed an online questionnaire (April-November 2022). Questions included those on consumption of twenty-one food/drink items that the NHS advises pregnant women to avoid/limit. The study is part of the Pregnancy, the Environment And nutRition (PEAR) Study. Summary statistics were used to determine proportions adhering to the guidance. Adjusted logistic regression was used to model the associations of adherence with demographic characteristics. RESULTS: Adherence was generally high (>90 % for eight of ten food/drink items to be avoided). However, among pre-pregnancy consumers, several items were not completely avoided, for example, 81 % (128/158) for game meat/gamebirds, 37 % (176/478) for cured meats and 17 % (81/467) for soft cheeses. Greater educational attainment (e.g. caffeinated soft drinks OR 2·25 (95 % CI 1·28, 3·94)), greater maternal age (e.g. oily fish 1·64 (1·05, 2·56)) and lower parity (e.g. caffeinated coffee 0.28 (0.11, 0.69)) were the most usual characteristics associated with adherence. CONCLUSION: Evidence of concerning levels of non-adherence for some food/drink items suggests a case for more education on some of the guidance, particularly for women with lower educational attainment, greater parity and greater maternal age. Further research on barriers to the implementation of the guidance is needed.

The RELIEF feasibility trial: topical lidocaine patches in older adults with rib fractures.

BACKGROUND: Lidocaine patches, applied over rib fractures, may reduce pulmonary complications in older patients. Known barriers to recruiting older patients in emergency settings necessitate a feasibility trial. We aimed to establish whether a definitive randomised controlled trial (RCT) evaluating lidocaine patches in older patients with rib fracture(s) was feasible. METHODS: This was a multicentre, parallel-group, open-label, feasibility RCT in seven hospitals in England and Scotland. Patients aged ≥65 years, presenting to ED with traumatic rib fracture(s) requiring hospital admission were randomised to receive up to 3×700 mg lidocaine patches (Ralvo), first applied in ED and then once daily for 72 hours in addition to standard care, or standard care alone. Feasibility outcomes were recruitment, retention and adherence. Clinical end points (pulmonary complications, pain and frailty-specific outcomes) and patient questionnaires were collected to determine feasibility of data collection and inform health economic scoping. Interviews and focus groups with trial participants and clinicians/research staff explored the understanding and acceptability of trial processes. RESULTS: Between October 23, 2021 and October 7, 2022, 206 patients were eligible, of whom 100 (median age 83 years; IQR 74-88) were randomised; 48 to lidocaine patches and 52 to standard care. Pulmonary complications at 30 days were determined in 86% of participants and 83% of expected 30-day questionnaires were returned. Pulmonary complications occurred in 48% of the lidocaine group and 59% in standard care. Pain and some frailty-specific outcomes were not feasible to collect. Staff reported challenges in patient compliance, unfamiliarity with research measures and overwhelming the patients with research procedures. CONCLUSION: Recruitment of older patients with rib fracture(s) in an emergency setting for the evaluation of lidocaine patches is feasible. Refinement of data collection, with a focus on the collection of pain, frailty-specific outcomes and intervention delivery are needed before progression to a definitive trial. TRIAL REGISTRATION NUMBER: ISRCTN14813929.

Provision of information by midwives for pregnant women in England on guidance on foods/drinks to avoid or limit.

BACKGROUND: The National Health Service (NHS) website gives guidance for pregnant women in England on foods/drinks to avoid or limit because of microbiological, toxicological or teratogenic hazards. These include, for example, some types of soft cheeses, fish/seafood and meat products. This website and midwives are trusted sources of information for pregnant women, but the ways in which midwives can be supported to provide clear and accurate information are unknown. AIMS: The aims were to: (1) determine midwives' accuracy of recall of information and confidence in delivering the guidance to women; (2) identify barriers to provision; (3) identify the ways in which midwives provide this information to women. METHODS: Registered Midwives practicing in England completed an online questionnaire. Questions included those on what information they provided and their confidence in delivering it, the ways they provided information on foods to avoid/limit, their recall of some of the guidance, and what resources they used. Ethics approval was given by the University of Bristol. RESULTS: More than 10% of midwives (n = 122) were 'Not at all confident/Don't know' in providing advice about ten items, including game meat/gamebirds (42% and 43%, respectively), herbal teas (14%) and cured meats (12%). Only 32% correctly recalled overall advice on eating fish, and only 38% the advice on tinned tuna. The main barriers to provision were lack of time in appointments and lack of training. The most usual methods of disseminating information were verbal (79%) and signposting to websites (55%). CONCLUSION: Midwives were often unconfident about their ability to provide accurate guidance, and recall on items tested was frequently mistaken. Delivery of guidance by midwives on foods to avoid or limit needs to be supported by appropriate training and access to resources, and sufficient time in appointments. Further research on barriers to the delivery and implementation of the NHS guidance is needed.

Severity and prevalence of ankyloglossia-associated breastfeeding symptoms: A systematic review and meta-analysis.

AIM: To evaluate breastfeeding symptoms associated with ankyloglossia/tongue-tie. METHODS: Databases included PubMed, Embase, CINAHL, PsycINFO, Web of Science, and Google Scholar. Eligible studies reported baseline breastfeeding symptoms/severity from tongue-tied infants. Two reviewers independently screened studies, extracted data, and assessed quality. Low-quality studies were excluded. Main outcomes were weighted mean severity scores for dyads with ankyloglossia relative to reference values for successful breastfeeding. Meta-analyses used inverse-variance-weighted random-effects models. RESULTS: Of 1328 screened studies, 39 were included (5730 infants with ankyloglossia). The mean LATCH score for patients with untreated ankyloglossia, 7.1 (95% CI: 6.7-7.4), was significantly below the good-breastfeeding threshold. The mean Infant Breastfeeding Assessment Tool score, 10.0 (8.2-11.7), was not significantly below the good-breastfeeding threshold. The mean Infant-Gastroesophageal Reflux Questionnaire-Revised score, 18.2 (10.5-26.0), was consistent with gastroesophageal reflux disease. The mean Breastfeeding Self-Efficacy Scale-Short Form score, 43.7 (39.3-48.1), indicated significant risk of cessation of exclusive breastfeeding within 1-3 months. Mean nipple pain was 4.9 (4.1-5.7) on a 0-10 scale, greater than typical scores for breastfeeding mothers without nipple damage. Total prevalence of breastfeeding difficulties was 49.3% (95% CI: 47.3-51.4%). Early, undesired weaning occurred in 20.3% (18.5-22.2%) of cases before intervention. CONCLUSION: Ankyloglossia is adversely associated with breastfeeding success and maternal well-being.

'Opportunity to bond and a sense of normality': Parent and staff views of cuddling babies undergoing therapeutic hypothermia in neonatal intensive care: 'CoolCuddle'.

BACKGROUND: Currently, parents whose sick babies are undergoing three days of cooling therapy for hypoxic-ischaemic encephalopathy in neonatal intensive care units (NICUs) are not permitted to cuddle their cooled babies, due to concerns of warming the baby or dislodging breathing tubes or vascular catheters. Parents want to stay and care for their cooled babies and have reported that bonding is adversely affected when they are not permitted to hold them. DESIGN AND PARTICIPANTS: Qualitative interviews with 21 parents of cooled babies in NICU (11 mothers and 10 fathers) and 10 neonatal staff (4 consultants and 6 nurses) explored their views and experiences of an intervention to enable parents to cuddle their cooled babies (CoolCuddle). Thematic analysis methods were used to develop the themes and compare them between parents and staff. RESULTS: Five themes were produced. Three themes were comparable between parents and staff: Closeness, a sense of normality and reassurance and support. An additional parent theme reflected their mixed feelings about initial participation as they were apprehensive, but felt that it was an amazing opportunity. Parents and staff described the closeness between parents and babies as important for bonding and breastfeeding. Fathers particularly appreciated the opportunity to hold and bond with their infants. Parents valued the reassurance and support received from staff, and the cuddles helped them feel more normal and more like a family at a very stressful time. In a final staff theme, they discussed the skills, number of staff and training needed to undertake CoolCuddle in NICU. CONCLUSIONS: Parents cuddling their babies during cooling therapy enhanced parent-infant bonding and family-centred care in NICU and was positively received. Adverse perinatal mental health, impaired mother-infant bonding and their effects on the establishment of breastfeeding may be ameliorated by introducing CoolCuddle. PATIENT CONTRIBUTION: Our parent advisors contributed to the interview topic guides and endorsed the themes from the analysis.

Interpersonal counselling versus perinatal-specific cognitive behavioural therapy for women with depression during pregnancy offered in routine psychological treatment services: a phase II randomised trial.

BACKGROUND: Up to one in eight women experience depression during pregnancy. In the UK, low intensity cognitive behavioural therapy (CBT) is the main psychological treatment offered for those with mild or moderate depression and is recommended during the perinatal period, however referral by midwives and take up of treatment by pregnant women is extremely low. Interpersonal Counselling (IPC) is a brief, low-intensity form of Interpersonal Psychotherapy (IPT) that focuses on areas of concern to service users during pregnancy. To improve psychological treatment for depression during pregnancy, the study aimed to assess the feasibility and acceptability of a trial of IPC for antenatal depression in routine NHS services compared to low intensity perinatal specific CBT. METHODS: We conducted a small randomised controlled trial in two centres. A total of 52 pregnant women with mild or moderate depression were randomised to receive 6 sessions of IPC or perinatal specific CBT. Treatment was provided by 12 junior mental health workers (jMHW). The primary outcome was the number of women recruited to the point of randomisation. Secondary outcomes included maternal mood, couple functioning, attachment, functioning, treatment adherence, and participant and staff acceptability. RESULTS: The study was feasible and acceptable. Recruitment was successful through scanning clinics, only 6 of the 52 women were recruited through midwives. 71% of women in IPC completed treatment. Women reported IPC was acceptable, and supervisors reported high treatment competence in IPC arm by jMHWs. Outcome measures indicated there was improvement in mood in both groups (Change in EPDS score IPC 4.4 (s.d. 5.1) and CBT 4.0 (s.d. 4.8). CONCLUSIONS: This was a feasibility study and was not large enough to detect important differences between IPC and perinatal specific CBT. A full-scale trial of IPC for antenatal depression in routine IAPT services is feasible. TRIAL REGISTRATION: This study has been registered with ISRCTN registry 11513120 . - date of registration 05/04/2018.

'Asking for help': a qualitative interview study exploring the experiences of interpersonal counselling (IPC) compared to low-intensity cognitive behavioural therapy (CBT) for women with depression during pregnancy.

BACKGROUND: Treating depression early in pregnancy can improve health outcomes for women and their children. Current low-intensity psychological therapy for perinatal depression is a supported self-help approach informed by cognitive behavioural therapy (CBT) principles. Interpersonal counselling (IPC) may be a more appropriate low-intensity talking therapy for addressing the problems experienced by pregnant women with depression. A randomised feasibility trial (ADAGIO) has compared the acceptability of offering IPC for mild-moderate antenatal depression in routine NHS services compared to low-intensity CBT. This paper reports on a nested qualitative study which explored women's views and expectations of therapy, experiences of receiving IPC, and Psychological Wellbeing Practitioners (PWPs - junior mental health workers) views of delivering the low-intensity therapy. METHODS: A qualitative study design using in-depth semi-structured interviews and focus groups. Thirty-two pregnant women received talking therapy within the ADAGIO trial; 19 contributed to the interview study from July 2019 to January 2020; 12 who had IPC and seven who had CBT. All six PWPs trained in IPC took part in a focus group or interview. Interviews and focus groups were recorded, transcribed, anonymised, and analysed using thematic methods. RESULTS: Pregnant women welcomed being asked about their mental health in pregnancy and having the chance to have support in accessing therapy. The IPC approach helped women to identify triggers for depression and explored relationships using strategies such as 'promoting self-awareness through mood timelines', 'identifying their circles of support', 'developing communication skills and reciprocity in relationships', and 'asking for help'. PWPs compared how IPC differed from their prior experiences of delivering low-intensity CBT. They reported that IPC included a useful additional emotional component which was relevant to the perinatal period. CONCLUSIONS: Identifying and treating depression in pregnancy is important for the future health of both mother and child. Low-intensity perinatal-specific talking therapies delivered by psychological wellbeing practitioners in routine NHS primary care services in England are acceptable to pregnant women with mild-moderate depression. The strategies used in IPC to manage depression, including identifying triggers for low mood, and communicating the need for help, may be particularly appropriate for the perinatal period. TRIAL REGISTRATION: ISRCTN 11513120. 02/05/2019.

Pregnant women's experiences of social distancing behavioural guidelines during the Covid-19 pandemic 'lockdown' in the UK, a qualitative interview study.

BACKGROUND: Covid-19 triggered the rapid roll-out of mass social distancing behavioural measures for infection control. Pregnant women were categorised as 'at risk' requiring extra vigilance with behavioural guidelines. Their understanding and ability to adhere to recommendations was unknown. OBJECTIVES: To complete a behavioural analysis of the determinants of recommended social distancing behaviour in pregnant women, according to the 'capability, opportunity, motivation and behaviour' ('COM-B') model to inform the development of recommendations/materials to support pregnant women in understanding and adhering to behavioural guidelines. DESIGN: Qualitative interview study with pregnant women in the Bristol area (UK). METHODS: Semi-structured telephone/videoconference interviews were conducted following a topic guide informed by the COM-B model, transcribed verbatim and subjected to framework analysis. Infographic materials were iteratively produced with stakeholder consultation, to support pregnant women. RESULTS: Thirty-one women participated (selected for demographic range). Women reported adhering to social distancing recommendations and intended to continue. COM-B analysis identified gaps in understanding around risk, vulnerability, and the extent of required social distancing, as well as facilitators of social distancing behaviour (e.g. social support, motivation to stay safe, home environment/resources). Additional themes around detrimental mental health effects and changes to maternity healthcare from the social distancing measures were identified. Infographic resources (plus midwife report) addressing women's key concerns were produced and disseminated. CONCLUSIONS: The COM-B model provided useful details of determinants of pregnant women's adherence to social distancing behaviours. The confusion of what being 'at risk' meant and varying interpretation of what was expected indicates a need for greater clarity around categories and guidance. The loss of maternity care and negative mental health effects of social distancing suggest a growing area of unmet health needs to be addressed in future.

Patients' and health professionals' perceptions of the LoDED (limit of detection and ECG discharge) strategy for low-risk chest pain management: a qualitative study.

BACKGROUND: Rapid discharge strategies for patients with low-risk chest pain using high-sensitivity troponin assays have been extensively evaluated. The adherence to, and acceptability of such strategies, has largely been explored using quantitative data. The aims of this integrated qualitative study were to explore the acceptability of the limit of detection and ECG discharge strategy (LoDED) to patients and health professionals, and to refine a discharge information leaflet for patients with low-risk chest pain. METHODS: Patients with low-risk chest pain who consented to a semi-structured interview were purposively sampled for maximum variation from four of the participating National Health Service sites between October 2018 and May 2019. Two focus groups with ED health professionals at two of the participating sites were completed in April and June 2019. RESULTS: A discharge strategy based on a single undetectable hs-cTn test (LoDED) was acceptable to patients. They trusted the health professionals who were treating them and felt reassured by other tests, (ECG) alongside blood test(s), even when the clinical assessment did not provide a firm diagnosis. In contrast, health professionals had reservations about the LoDED strategy, including concern about identifying low-risk patients and a shortened patient observation period. Findings from 11 patient interviews and 2 staff focus groups (with 20 clinicians) centred around three overarching themes: acceptability of the LoDED strategy, perceptions of symptom severity and uncertainty, and patient discharge information. CONCLUSION: Rapid discharge for low-risk chest pain is acceptable to patients, but clinicians reported some reticence in implementing the LoDED strategy. Further work is required to optimise discharge discussions and information provision for patients.

Exploring the use and experience of an infant feeding genogram to facilitate an assets-based approach to support infant feeding.

BACKGROUND: A lack of perceived social support influences women's infant feeding behaviours. The Infant Feeding Genogram is a visual co-constructed diagram which details people/services that can provide support to women and can facilitate a connection between mothers and their existing assets landscape. The aim of this study is to explore women's and infant feeding helpers' experiences and use of an infant feeding genogram delivered to the intervention group of the "Assets-based infant feeding help Before and After birth (ABA)" randomised feasibility trial. METHODS: 103 primiparous mothers aged 16+ years were recruited to the trial (trial registration number) in two sites (Site A and Site B) with low breastfeeding prevalence in the UK. Infant feeding helpers (IFHs) co-constructed a genogram at the first antenatal meeting for the intervention group (n = 50), and then provided proactive, woman-centered support from ~ 32 weeks gestation to up to 5 months postnatal. Infant feeding helpers' and women's experiences of the infant feeding genogram were collected via interviews or focus groups. Completed genograms were shared with researchers. Content analysis of the genograms and qualitative data from the interviews and focus groups were analysed thematically. RESULTS: Data comprised 32 completed genograms, and qualitative insights from all 13 infant feeding helpers (two focus groups; 4 interviews) and interviews with a purposive sample of 21 of 50 intervention group women between 4 and 21 weeks after birth. Content analysis of the genograms highlighted variations, with more personal, individualised genograms completed at Site B compared to Site A. The perceived impact of the genogram was related to the IFHs' application of the tool. The genogram was either used as intended to raise women's awareness of available assets and motivate help-seeking behaviour, or as a data collection tool with limited perceived utility. Negative and positive unintended consequences of genogram use were highlighted. CONCLUSIONS: The genogram has the potential to offer a woman, family and community-centred approach that focusses on building assets for infant feeding. However, variations in genogram application indicate that revised training is required to clarify the purpose and ensure it is used as intended. TRIAL REGISTRATION: ISRCTN ISRCTN14760978 ; Registered 30 January 2017.

Women's and peer supporters' experiences of an assets-based peer support intervention for increasing breastfeeding initiation and continuation: A qualitative study.

BACKGROUND AND CONTEXT: Breastfeeding peer support is valued by women, but UK trials have not demonstrated efficacy. The ABA feasibility trial offered proactive peer support underpinned by behaviour change theory and an assets-based approach to women having their first baby, regardless of feeding intention. This paper explores women's and infant feeding helpers' (IFHs) views of the different components of the ABA intervention. SETTING AND PARTICIPANTS: Trained IFHs offered 50 women an antenatal meeting to discuss infant feeding and identify community assets in two English sites-one with a paid peer support service and the other volunteer-led. Postnatally, daily contact was offered for the first 2 weeks, followed by less frequent contact until 5 months. METHODS: Interviews with 21 women and focus groups/interviews with 13 IFHs were analysed using thematic and framework methods. RESULTS: Five themes are reported highlighting that women talked positively about the antenatal meeting, mapping their network of support, receiving proactive contact from their IFH, keeping in touch using text messaging and access to local groups. The face-to-face antenatal visit facilitated regular text-based communication both in pregnancy and in the early weeks after birth. Volunteer IFHs were supportive of and enthusiastic about the intervention, whereas some of the paid IFHs disliked some intervention components and struggled with the distances to travel to participants. CONCLUSIONS: This proactive community assets-based approach with a woman-centred focus was acceptable to women and IFHs and is a promising intervention warranting further research as to its effect on infant feeding outcomes.

The ABA intervention for improving breastfeeding initiation and continuation: Feasibility study results.

The UK has low breastfeeding rates, with socioeconomic disparities. The Assets-based feeding help Before and After birth (ABA) intervention was designed to be inclusive and improve infant feeding behaviours. ABA is underpinned by the behaviour change wheel and offers an assets-based approach focusing on positive capabilities of individuals and communities, including use of a Genogram. This study aimed to investigate feasibility of intervention delivery within a randomised controlled trial (RCT). Nulliparous women ≥16 years, (n = 103) from two English sites were recruited and randomised to either intervention or usual care. The intervention - delivered through face-to-face, telephone and text message by trained Infant Feeding Helpers (IFHs) - ran from 30-weeks' gestation until 5-months postnatal. Outcomes included recruitment rates and follow-up at 3-days, 8-weeks and 6-months postnatal, with collection of future full trial outcomes via questionnaires. A mixed-methods process evaluation included qualitative interviews with 30 women, 13 IFHs and 17 maternity providers; IFH contact logs; and fidelity checking of antenatal contact recordings. This study successfully recruited women, including teenagers, from socioeconomically disadvantaged areas; postnatal follow-up rates were 68.0%, 85.4% and 80.6% at 3-days, 8-weeks and 6-months respectively. Breastfeeding at 8-weeks was obtained for 95.1% using routine data for non-responders. It was possible to recruit and train peer supporters to deliver the intervention with adequate fidelity. The ABA intervention was acceptable to women, IFHs and maternity services. There was minimal contamination and no evidence of intervention-related harm. In conclusion, the intervention is feasible to deliver within an RCT, and a definitive trial required.

Understanding the influence of parent-clinician communication on antibiotic prescribing for children with respiratory tract infections in primary care: a qualitative observational study using a conversation analysis approach.

BACKGROUND: Acute respiratory tract infections (RTI) in children are a common reason for antibiotic prescribing. Clinicians' prescribing decisions are influenced by perceived parental expectations for antibiotics, however there is evidence that parents actually prefer to avoid antibiotics. This study aimed to investigate the influence of parent-clinician communication on antibiotic prescribing for RTI in children in England. METHODS: A mixed methods analysis of videoed primary care consultations for children (under 12 years) with acute cough and RTI. Consultations were video-recorded in six general practices in southern England, selected for socio-economic diversity. 56 recordings were transcribed in detail and a subset of recordings and transcripts used to develop a comprehensive interaction-based coding scheme. The scheme was used to examine communication practices between parents and clinicians and how these related to antibiotic or non-antibiotic treatment strategies. RESULTS: Parents' communication rarely implied an expectation for antibiotics, some explicitly offering a possible viral diagnosis. Clinicians mostly gave, or implied, a viral diagnosis and mainly recommended non-antibiotic treatment strategies. In the minority of cases where parents' communication behaviours implied they may be seeking antibiotic treatment, antibiotics were not usually prescribed. Where clinicians did prescribe antibiotics, they voiced concern about symptoms or signs, including chest pain, discoloured phlegm, prolonged fever, abnormal chest sounds, or pink /bulging ear drums. CONCLUSIONS: We found little evidence of a relationship between parents' communication behaviours and antibiotic prescribing. Rather, where antibiotics were prescribed, this was associated with clinicians' expressed concerns regarding symptoms and signs.

Development of an intervention to reduce antibiotic use for childhood coughs in UK primary care using critical synthesis of multi-method research.

BACKGROUND: Overuse of antibiotics contributes to the global threat of antimicrobial resistance. Antibiotic stewardship interventions address this threat by reducing the use of antibiotics in occasions or doses unlikely to be effective. We aimed to develop an evidence-based, theory-informed, intervention to reduce antibiotic prescriptions in primary care for childhood respiratory tract infections (RTI). This paper describes our methods for doing so. METHODS: Green and Krueter's Precede/Proceed logic model was used as a framework to integrate findings from a programme of research including 5 systematic reviews, 3 qualitative studies, and 1 cohort study. The model was populated using a strength of evidence approach, and developed with input from stakeholders including clinicians and parents. RESULTS: The synthesis produced a series of evidence-based statements summarizing the quantitative and qualitative evidence for intervention elements most likely to result in changes in clinician behaviour. Current evidence suggests that interventions which reduce clinical uncertainty, reduce clinician/parent miscommunication, elicit parent concerns, make clear delayed or no-antibiotic recommendations, and provide clinicians with alternate treatment actions have the best chance of success. We designed a web-based within-consultation intervention to reduce clinician uncertainty and pressure to prescribe, designed to be used when children with RTI present to a prescribing clinician in primary care. CONCLUSIONS: We provide a worked example of methods for the development of future complex interventions in primary care, where multiple factors act on multiple actors within a complex system. Our synthesis provided intervention guidance, recommendations for practice, and highlighted evidence gaps, but questions remain about how best to implement these recommendations. The funding structure which enabled a single team of researchers to work on a multi-method programme of related studies (NIHR Programme Grant scheme) was key in our success. TRIAL REGISTRATION: The feasibility study accompanying this intervention was prospectively registered with the ISRCTN registry ( ISRCTN23547970 ), on 27 June 2014.

"Giving us hope": Parent and neonatal staff views and expectations of a planned family-centred discharge process (Train-to-Home).

BACKGROUND: Preparing families and preterm infants for discharge is relatively unstructured in many UK neonatal units (NNUs). Family-centred neonatal care and discharge planning are recommended but variable. DESIGN AND PARTICIPANTS: Qualitative interviews with 37 parents of infants in NNUs, and 18 nursing staff and 5 neonatal consultants explored their views of discharge planning and perceptions of a planned family-centred discharge process (Train-to-Home). Train-to-Home facilitates communication between staff and parents throughout the neonatal stay, using a laminated train and parent booklets. RESULTS: Parents were overwhelmingly positive about Train-to-Home. They described being given hope, feeling in control and having something visual to show their baby's progress. They reported positive involvement of fathers and families, how predicted discharge dates helped them prepare for home and ways staff engaged with Train-to-Home when communicating with them. Nursing staff reactions were mixed-some were uncertain about when to use it, but found the visual images powerful. Medical staff in all NNUs were positive about the intervention recognizing that it helped in communicating better with parents. CONCLUSIONS: Using a parent-centred approach to communication and informing parents about the needs and progress of their preterm infant in hospital is welcomed by parents and many staff. This approach meets the recommended prioritization of family-centred care for such families. Predicted discharge dates helped parents prepare for home, and the ways staff engaged with Train-to-Home when communicating with them helped them feel more confident as well as having something visual to show their baby's progress.

Influence of Clinical Communication on Parents' Antibiotic Expectations for Children With Respiratory Tract Infections.

PURPOSE: The purpose of this study was to understand clinicians' and parents' perceptions of communication within consultations for respiratory tract infections (RTI) in children and what influence clinician communication had on parents' understanding of antibiotic treatment. METHODS: We video recorded 60 primary care consultations for children aged 3 months to 12 years who presented with RTI and cough in 6 primary care practices in England. We then used purposive sampling to select 27 parents and 13 clinicians for semistructured video-elicitation interviews. The videos were used as prompts to investigate participants' understanding and views of communication within the consultations. We analyzed the interview data thematically. RESULTS: While clinicians commonly told parents that antibiotics are not effective against viruses, this did not have much impact on parents' beliefs about the need to consult or on their expectations concerning antibiotics. Parents believed that antibiotics were needed to treat more severe illnesses, a belief that was supported by the way clinicians accompanied viral diagnoses with problem-minimizing language and antibiotic prescriptions with more problem-oriented language. Antibiotic prescriptions tended to confirm parents' beliefs about what indicated illness severity, which often took into account the wider impact on a child's life. While parents understood antimicrobial resistance poorly, most held beliefs that supported reduced antibiotic prescribing. A minority attributed it to resource rationing, however. CONCLUSIONS: Clinician communication and prescribing behavior confirm parents' beliefs that antibiotics are needed to treat more severe illnesses. Interventions to reduce antibiotic expectations need to address communication within the consultation, prescribing behavior, and lay beliefs.

The First-aid Advice and Safety Training (FAST) parents programme for the prevention of unintentional injuries in preschool children: a protocol.

BACKGROUND: Unintentional injury is the leading cause of preventable death in children in the UK, and 0-4-year-olds frequently attend emergency departments following injuries in the home. Parenting programmes designed to support parents, promote behaviour change and enhance parent-child relationships have been shown to improve health outcomes in children. It is not known whether group-based parenting programmes have the potential to prevent unintentional injuries in preschool children. METHODS: A study to develop a group-based parenting programme to prevent unintentional home injuries in preschool children, and assess the feasibility of evaluation through a cluster-randomised controlled trial. The intervention, designed for parents of children who have sustained a medically attended injury, will be developed with two voluntary sector organisations. The feasibility study will assess ability to recruit parents, deliver the programme and follow-up participants. Participants will complete questionnaires at baseline, 3 months and 6 months, and report injuries in their preschool children using a tool designed and validated for this study. Qualitative methods will assess user and deliverer perceptions of the programme. DISCUSSION: This study will develop the first group-based parenting programme to prevent injuries in preschool children, and design tools for parent-reported injury outcomes. A key challenge will be to recruit parents to participate in a manner that is non-stigmatising, and does not result in feelings of guilt or belief that they are perceived to be a bad parent. The findings will be used to prepare a trial to assess the effectiveness and cost-effectiveness of the intervention.

Implementation of the CHIldren with acute COugh (CHICO) intervention to improve antibiotics management: a qualitative study in primary care.

BACKGROUND: Childhood respiratory tract infections (RTIs) are common and can lead to unnecessary antibiotic use and antimicrobial resistance. The CHIldren with COugh (CHICO) intervention incorporates a clinician-focused algorithm (STARWAVe) to predict future hospitalisation risk, elicitation of carer concerns, and a carer-focused personalised leaflet recording treatment decisions and safety-netting information. AIM: To examine the implementation of the CHICO intervention by primary care clinicians. DESIGN AND SETTING: A qualitative study with primary care clinicians in England taking part in the CHICO randomised controlled trial. METHOD: Interviews explored the CHICO intervention's acceptability and use. Clinicians from a range of practices with high and low antibiotic dispensing rates were recruited. Normalisation process theory underpinned data collection and thematic analysis. RESULTS: Most clinicians liked the intervention because it was quick and easy to use, it helped elicit carer concerns, and reassured clinicians and carers of the appropriateness of treatment decisions. However, clinicians used it as a supportive aid for treatment decisions rather than as a tool for behaviour change. The accompanying advice leaflet helped explain treatment decisions and support self-care. The intervention did not always align with clinicians' usual processes, which could affect use. Increased familiarisation with the algorithm led to reduced intervention use, which was further reduced during the COVID-19 pandemic as a result of changes to practice and remote consultations. CONCLUSION: Clinicians found the CHICO intervention useful to support decision making around antibiotic prescribing and it helped discussions with carers about concerns and treatment decisions. The intervention may need to be adapted to align more with clinicians' consultation flow and remote consultations.