Smoking, nicotine and pregnancy 2 (SNAP2) trial: protocol for a randomised controlled trial of an intervention to improve adherence to nicotine replacement therapy during pregnancy.

INTRODUCTION: Smoking during pregnancy is harmful to unborn babies, infants and women. Nicotine replacement therapy (NRT) is offered as the usual stop-smoking support in the UK. However, this is often used in insufficient doses, intermittently or for too short a time to be effective. This randomised controlled trial (RCT) explores whether a bespoke intervention, delivered in pregnancy, improves adherence to NRT and is effective and cost-effective for promoting smoking cessation. METHODS AND ANALYSIS: A two-arm parallel-group RCT was conducted for pregnant women aged ≥16 years and who smoke ≥1 daily cigarette (pre-pregnancy smoked ≥5) and who agree to use NRT in an attempt to quit. Recruitment is from antenatal care settings and via social media adverts. Participants are randomised using blocked randomisation with varying block sizes, stratified by gestational age (<14 or ≥14 weeks) to receive: (1) usual care (UC) for stop smoking support or (2) UC plus an intervention to increase adherence to NRT, called 'Baby, Me and NRT' (BMN), comprising adherence counselling, automated tailored text messages, a leaflet and website. The primary outcome is biochemically validated smoking abstinence at or around childbirth, measured from 36 weeks gestation. Secondary outcomes include NRT adherence, other smoking measures and birth outcomes. Questionnaires collect follow-up data augmented by medical record information. We anticipate quit rates of 10% and 16% in the control and intervention groups, respectively (risk ratio=1.6). By recruiting 1320 participants, the trial should have 90% power (alpha=5%) to detect this intervention effect. An economic analysis will use the Economics of Smoking in Pregnancy model to determine cost-effectiveness. ETHICS AND DISSEMINATION: Ethics approval was granted by Bloomsbury National Health Service's Research Ethics Committee (21/LO/0123). Written informed consent will be obtained from all participants. Findings will be disseminated to the public, funders, relevant practice/policy representatives, researchers and participants. TRIAL REGISTRATION NUMBER: ISRCTN16830506. PROTOCOL VERSION: 5.0, 10 Oct 2023.

Agreement and Disparities between Women and Stop-Smoking Specialists about How to Promote Adherence to Nicotine Replacement Therapy in Pregnancy.

Evidence for the effectiveness of nicotine replacement therapy (NRT) for smoking-cessation in pregnancy is weak. This has been attributed to insufficient dosing and low adherence. This study investigated the acceptability of key messages and delivery modes for a behavioral intervention to increase NRT adherence in pregnancy. Semi-structured telephone interviews were carried out with pregnant or postpartum women aged ≥16 from across England, who had been offered NRT during pregnancy as part of a quit attempt and who struggled to quit (n = 10), and a focus group with stop-smoking specialists from across England (n = 6). The two data sources were coded separately using a thematic approach and then integrated to compare perspectives. Women and specialists agreed on message tone and delivery modes. However, views diverged on the most influential sources for certain messages and whether some information should be given proactively or reactively. There was also disagreement over which messages were novel and which were routinely delivered. This study demonstrates the value of capturing and integrating different perspectives and informational requirements when developing behavior-change interventions. The findings provide useful insights for designing a pregnancy-specific NRT adherence intervention that is acceptable to both those who will deliver and receive it.

Comparing auditory perception and speech production outcomes: non-language specific assessment of auditory perception and speech production in children with cochlear implants.

Language-independent assessment tools evaluate the progress of children who receive a cochlear implant, allowing large pooling of data for better access to insurers and other health care professionals. One hundred and seventeen children from centres in the United Kingdom, Iran and Turkey were assessed on two measures over a five-year test interval. There is a significant improvement over time for the Categories of Auditory Performance (CAP) and Speech Intelligibility Rating (SIR) measures. There was a significant difference between scores for different language groups: accounted for by the differences in age at implantation. There was a significant effect of age at implantation up to three years of device use. There were high correlations between the CAP and SIR scores. A longer duration of deafness resulted in a higher score for both scales; however, there was no relationship when correlated for age. Finally, the CAP pre-operative score allows us to predict the post-operative SIR scores. The scales are validated; reliable measures which can be used across countries and languages. This allows greater ability to pool data allowing data to be generalised across population groups, providing more power to prove that cochlear implantation is a viable treatment for children with bilateral severe-to-profound hearing loss.

TeenEARS: development of a pilot assessment battery for cochlear implanted adolescents.

Changes in selection criteria have led to the inclusion of pre-lingually deafened adolescents as potential cochlear implant candidates, depending on their degree of residual hearing, access to and use of acoustic amplification, use of oral communication, and other factors such as motivation and support. Outcomes results in adolescents vary widely, and it has become evident that there is a need for a test battery that can assess a wide range of skills over time. This article presents the development and validation of one such test battery: TeenEARS. Eleven tests were assessed for inclusion in the test battery. Consideration was given to the ability of the test to measure improvement over time; the fact that there needed to be easier and more difficult tests in terms of language, communication and listening; the need for closed and open-set assessments; and a range of listening tasks: from sounds to conversational language. Data on 23 adolescents assessed and judgment based on clinical experience resulted in eight tests being included in the TeenEARS test battery.

Assessment of auditory skills in 140 cochlear implant children using the EARS protocol.

Auditory performance of cochlear implant (CI) children was assessed with the Listening Progress Profile (LiP) and the Monosyllabic-Trochee-Polysyllabic-Word Test (MTP) following the EARS protocol. Additionally, the 'initial drop' phenomenon, a recently reported decrease of auditory performance occurring immediately after first fitting, was investigated. Patients were 140 prelingually deafened children from various clinics and centers worldwide implanted with a MEDEL COMBI 40/40+. Analysis of LiP data showed a significant increase after 1 month of CI use compared to preoperative scores (p < 0.01). No initial decrease was observed with this test. Analysis of MTP data revealed a significant improvement of word recognition after 6 months (p < 0.01), with a significant temporary decrease after initial fitting (p < 0.01). With both tests, children's auditory skills improved up to 2 years. Amount of improvement was negatively correlated with age at implantation.