Recommendations for data collection in cohort studies of preterm born individuals - The RECAP Preterm Core Dataset.

BACKGROUND: Preterm birth (before 37 completed weeks of gestation) is associated with an increased risk of adverse health and developmental outcomes relative to birth at term. Existing guidelines for data collection in cohort studies of individuals born preterm are either limited in scope, have not been developed using formal consensus methodology, or did not involve a range of stakeholders in their development. Recommendations meeting these criteria would facilitate data pooling and harmonisation across studies. OBJECTIVES: To develop a Core Dataset for use in longitudinal cohort studies of individuals born preterm. METHODS: This work was carried out as part of the RECAP Preterm project. A systematic review of variables included in existing core outcome sets was combined with a scoping exercise conducted with experts on preterm birth. The results were used to generate a draft core dataset. A modified Delphi process was implemented using two stages with three rounds each. Three stakeholder groups participated: RECAP Preterm project partners; external experts in the field; people with lived experience of preterm birth. The Delphi used a 9-point Likert scale. Higher values indicated greater importance for inclusion. Participants also suggested additional variables they considered important for inclusion which were voted on in later rounds. RESULTS: An initial list of 140 data items was generated. Ninety-six participants across 22 countries participated in the Delphi, of which 29% were individuals with lived experience of preterm birth. Consensus was reached on 160 data items covering Antenatal and Birth Information, Neonatal Care, Mortality, Administrative Information, Organisational Level Information, Socio-economic and Demographic information, Physical Health, Education and Learning, Neurodevelopmental Outcomes, Social, Lifestyle and Leisure, Healthcare Utilisation and Quality of Life. CONCLUSIONS: This core dataset includes 160 data items covering antenatal care through outcomes in adulthood. Its use will guide data collection in new studies and facilitate pooling and harmonisation of existing data internationally.

Development of a data classification system for preterm birth cohort studies: the RECAP Preterm project.

BACKGROUND: The small sample sizes available within many very preterm (VPT) longitudinal birth cohort studies mean that it is often necessary to combine and harmonise data from individual studies to increase statistical power, especially for studying rare outcomes. Curating and mapping data is a vital first step in the process of data harmonisation. To facilitate data mapping and harmonisation across VPT birth cohort studies, we developed a custom classification system as part of the Research on European Children and Adults born Preterm (RECAP Preterm) project in order to increase the scope and generalisability of research and the evaluation of outcomes across the lifespan for individuals born VPT. METHODS: The multidisciplinary consortium of expert clinicians and researchers who made up the RECAP Preterm project participated in a four-phase consultation process via email questionnaire to develop a topic-specific classification system. Descriptive analyses were calculated after each questionnaire round to provide pre- and post- ratings to assess levels of agreement with the classification system as it developed. Amendments and refinements were made to the classification system after each round. RESULTS: Expert input from 23 clinicians and researchers from the RECAP Preterm project aided development of the classification system's topic content, refining it from 10 modules, 48 themes and 197 domains to 14 modules, 93 themes and 345 domains. Supplementary classifications for target, source, mode and instrument were also developed to capture additional variable-level information. Over 22,000 individual data variables relating to VPT birth outcomes have been mapped to the classification system to date to facilitate data harmonisation. This will continue to increase as retrospective data items are mapped and harmonised variables are created. CONCLUSIONS: This bespoke preterm birth classification system is a fundamental component of the RECAP Preterm project's web-based interactive platform. It is freely available for use worldwide by those interested in research into the long term impact of VPT birth. It can also be used to inform the development of future cohort studies.

Parental and health professional evaluations of a support service for parents of excessively crying infants.

BACKGROUND: The 'Surviving Crying' study was designed to develop and provisionally evaluate a support service for parents of excessively crying babies, including its suitability for use in the United Kingdom (UK) National Health Service (NHS). The resulting service includes three materials: a website, a printed booklet, and a Cognitive Behaviour Therapy (CBT) programme delivered to parents by a qualified professional. This study aimed to measure whether parents used the materials and to obtain parents' and NHS professionals' evaluations of whether they are fit for purpose. Parents were asked about participating in a randomised controlled trial (RCT) to evaluate the materials fully in health service use. METHODS: Participants were 57 parents with babies they judged to be crying excessively and 96 NHS Health Visitors (HVs). Parental use and parents' and HVs' ratings of the Surviving Crying materials were measured. RESULTS: Thirty four parents reported using the website, 24 the printed booklet and 24 the CBT sessions. Parents mostly accessed the website on mobile phones or tablets and use was substantial. All the parents and almost all HVs who provided data judged the materials to be helpful for parents and suitable for NHS use. If offered a waiting list control group, 85% of parents said they would have been willing to take part in a full RCT evaluation of the Surviving Crying package. DISCUSSION AND CONCLUSIONS: The findings identify the need for materials to support parents of excessively crying babies within national health services in the UK. The Surviving Crying support package appears suitable for this purpose and a full community-level RCT of the package is feasible and likely to be worthwhile. Limitations to the study and barriers to delivery of the services were identified, indicating improvements needed in future research. TRIAL REGISTRATION: Study Registration no. ISRCTN84975637 .

A pilot feasibility randomised controlled trial of an adjunct brief social network intervention in opiate substitution treatment services.

BACKGROUND: Approximately 3% of people receiving opioid substitution therapy (OST) in the UK manage to achieve abstinence from prescribed and illicit drugs within three years of commencing treatment. Involvement of families and wider social networks in supporting psychological treatment may be an effective strategy in facilitating recovery, and this pilot study aimed to evaluate the impact of a social network-focused intervention for patients receiving OST. METHODS: A two-site, open feasibility trial randomised patients receiving OST for at least 12 months but still reporting illicit opiate use in the past 28 days to one of three treatments: 1) treatment as usual (TAU), 2) Brief Social Behaviour and Network Therapy (B-SBNT) + TAU, or 3) Personal Goal Setting (PGS) + TAU. The two active interventions consisted of 4 sessions. There were 3 aims: 1) test the feasibility of recruiting OST patients to a trial of B-SBNT, and following them up over 12 months; 2) test the feasibility of training clinicians to deliver B-SBNT; 3) test whether B-SBNT reduces heroin use 3 and 12 months after treatment, and to explore potential mediating factors. The primary outcome for aim 3 was number of days of heroin use in the past month, and a range of secondary outcome measures were specified in advance (level of drug dependence, mental health, social satisfaction, therapist rapport, treatment satisfaction, social network size and support). RESULTS: A total of 83 participants were randomised, and 70 (84%) were followed-up at 12 months. Fidelity analysis of showed that B-SBNT sessions were clearly distinguishable from PGS and TAU sessions, suggesting it was possible to train clinical staff to an adequate level of competence. No significant differences were found between the 3 intervention arms in the primary or secondary outcome measures. Attendance at psychosocial treatment intervention sessions was low across all three arms (44% overall). CONCLUSIONS: Patients receiving OST can be recruited into a trial of a social network-based intervention, but poor attendance at treatment sessions makes it uncertain whether an adequate dose of treatment was delivered. In order to achieve the benefits of psychosocial interventions, further work is needed to overcome poor engagement. TRIAL REGISTRATION: ISRCTN Trial Registration Number: ISRCTN22608399 . Date of registration: 27/04/2012. Date of first randomisation: 14/08/2012.

Older adult problem drinkers: who presents for alcohol treatment?

OBJECTIVES: To describe a treatment population of older adults (60+ years) assessed for alcohol treatment over a 20-year period. METHOD: Retrospective analysis of alcohol treatment assessment data relating to all older adults assessed by one UK NHS Trust Community Alcohol Team (n = 585) between April 1988 and March 2008. RESULTS: Over the 20-year period, the number of assessments per year increased though the demographic profile of those assessed for treatment remained the same: male (62%), white ethnic origin (94%) and average age 65.7 years. The average amount of alcohol consumed per week was 102.91 units. Most were drinking alcohol on a daily basis (79%), mainly spirits (79%), at home (84%), alone (82%) and 'to reduce tension/anxiety' (22%). The average length of having had an alcohol problem was 9.7 years. Significant gender differences were found in terms of demographic profile and drinking patterns. CONCLUSIONS: The older adults assessed for alcohol treatment were drinking in amounts comparable to the treatment population of younger adult problem drinkers, men more so than women. The majority were not reporting problems with their drinking until they were on average in their middle-to-late 50s and were therefore considered to be late onset 'reactors' rather than early onset 'survivors' of longer term heavy drinking patterns reported in earlier studies.

A support package for parents of excessively crying infants: development and feasibility study.

BACKGROUND: Around 20% of 1- to 4-month-old infants cry for long periods without an apparent reason. Traditionally, this was attributed to gastrointestinal disorder ('colic'), but evidence shows that just 5% of infants cry a lot because of organic disturbances; in most cases, the crying is attributable to normal developmental processes. This has led to a focus on the impact of the crying on parents. Parental vulnerabilities influence how parents evaluate and respond to the crying and predict adverse outcomes. By developing evidence-based services that support parents, this study was designed to take the first steps towards national health services that enhance the coping and well-being of parents whose babies excessively cry. Related aims were to improve these infants' outcomes and how NHS money is spent. OBJECTIVES: To develop a novel intervention package to support parents of excessively crying infants and to examine the feasibility of delivering and evaluating it in the NHS. DESIGN: Stage 1 of this study aimed to (1) complete a literature review to identify example support materials, (2) obtain parents' guidance on the support needed when a baby cries excessively, together with their evaluation of the example materials, and (3) develop a support package based on the results. Stage 2 aimed to (1) recruit 60 parents whose babies were currently excessively crying, (2) assess parents' and NHS professionals' willingness to complete a study of the support package, (3) measure the use and evaluation of the package components, (4) estimate the package component costs and (5) provide evidence on the feasibility and methods for a large-scale trial. SETTING: Primary health care. PARTICIPANTS: Stage 1: 20 parents of previously excessively crying infants and 55 health visitors (HVs) or specialist community public health nurses (SCPHNs). Stage 2: 57 parents of currently excessively crying infants and 124 HVs/SCPHNs. INTERVENTIONS: The support package included a website, a printed booklet and a programme of cognitive-behavioural therapy-based sessions delivered to parents by a qualified practitioner. MAIN OUTCOME MEASURES: (1) Demographic data, (2) figures for parents' use of the package components and continuation in the study, (3) parents' and HVs'/SCPHNs' ratings of the package components and suitability for NHS use, (4) questionnaire measures of parental well-being and infant health and (5) costs. RESULTS: Most parents (95%) accessed the website or printed materials and half (51%) attended the practitioner sessions. All 52 parents and 85% of HVs/SCPHNs providing data would support the inclusion of the package in the NHS. It was associated with reduced parental frustration, anxiety, depression, reported infant crying and contacts with health professionals and increased knowledge about crying. Methods for a full trial and figures for the cost of excessive infant crying for the NHS and each package element were identified. LIMITATIONS: No control group was included. Most of the recruited parents were white, well educated and in stable relationships. CONCLUSIONS: Parents and HVs/SCPHNs recognise the need for NHS provisions that support parents of excessively crying babies and consider the materials developed to meet that need. A full-scale randomised controlled trial is feasible and desirable. TRIAL REGISTRATION: Current Controlled Trials ISRCTN84975637. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 56. See the NIHR Journals Library website for further project information.

INTRODUCTION: This study is a first step in developing evidence-based NHS services to support parents whose babies cry excessively. BACKGROUND: Around one-fifth of babies cry a lot without an apparent reason. This 'excessive' infant crying used to be known as 'colic' and was blamed on indigestion pain. Recent evidence suggests that only 5% of infants taken to the doctor because of excessive crying are actually unwell. The crying peak and 'unsoothable' crying bouts that alarm parents in early infancy usually stop by themselves once the baby is 5 months old and are probably attributable to normal developmental processes. Although most babies who cry a lot are well, the crying can distress parents and lead to poor consequences; these include overfeeding, stopping breastfeeding, maternal depression, poor parent­child relationships, problems with child development and, in extreme cases, infant abuse. By developing NHS services that support parents to manage excessive infant crying, this project aimed to improve parents' well-being, long-term outcomes and how NHS money is spent. FINDINGS: In stage 1 of the study (development of an intervention package), the research evidence was reviewed and parents whose babies previously cried excessively and NHS health visitors (HVs) and specialist community public health nurses (SCPHNs) were involved to develop evidence-based support materials. These included a website, a printed booklet and support sessions with a qualified practitioner. In stage 2 (a feasibility study of package implementation in the NHS), HVs/SCPHNs helped to recruit 57 parents whose babies were currently excessively crying. On average, these babies cried for 6.9 hours per day. Most parents accessed the website or booklet and half attended the practitioner sessions. The package was associated with reduced parental anxiety and depression, and all 52 parents and 85% of HVs/SCPHNs who gave an opinion considered that it should be included in the NHS. Findings for the cost of each package element and suggestions for future services were provided.

Improving developmental and educational support for children born preterm: evaluation of an e-learning resource for education professionals.

OBJECTIVES: Children born preterm are at higher risk for special educational needs and poor academic attainment compared with term-born peers, yet education professionals receive limited training and have poor knowledge of preterm birth. We have developed an interactive e-learning resource and evaluated its efficacy in improving teachers' knowledge of preterm birth and their confidence in supporting the learning of children born preterm. SETTING: Eight primary, infant or junior schools in England. PARTICIPANTS: 61 teachers of children aged 4-11 years, of which 55 (90%) were female. INTERVENTION: Interactive e-learning resource designed to improve education professionals' knowledge of long-term outcomes following preterm birth and strategies that can be used to support children's learning (www.pretermbirth.info). In a repeated measures design, participants were given up to 30 days access to the e-learning resource, before and after which they completed the Preterm Birth Knowledge Scale (PB-KS; scores 0-33; higher scores indicate greater knowledge) to assess knowledge of outcomes of prematurity. Four Likert scale items were used to assess confidence in supporting children's learning and 10 items were used to evaluate the utility of the resource. PB-KS scores and responses on confidence item were compared pre-resource and post-resource use. RESULTS: PB-KS scores significantly increased after accessing the e-learning resource (median (95% CI): pre-resource 13 (11 to 14); post-resource 29 (28 to 30)), equating to a 2.6 SD increase in PB-KS scores. Teachers' confidence in supporting children born preterm was also significantly improved after using the resource. The utility of the resource was evaluated positively by participants with 97% reporting that they would recommend its use to others. CONCLUSIONS: The e-learning resource substantially improved teachers' knowledge of preterm birth and their confidence in supporting preterm children in the classroom. Use of this resource may represent a key advance in improving educational outcomes for children born preterm.

Development of materials to support parents whose babies cry excessively: findings and health service implications.

AimTo develop evidence-based materials which provide information and support for parents who are concerned about their baby's excessive crying. As well as meeting these parents' needs, the aim was to develop a package of materials suitable for use by the UK National Health Service (NHS). BACKGROUND: Parents report that around 20% of infants in Western countries cry excessively without an apparent reason during the first four months of age. Traditionally, research has focused on the crying and its causes. However, evidence is growing that how parents evaluate and respond to the crying needs to receive equal attention. This focus encompasses parental resources, vulnerabilities, well-being and mental health. At present, the UK NHS lacks a set of routine provisions to support parents who are concerned about their baby's excessive crying. The rationales, methods and findings from a study developing materials for this purpose are reported. METHOD: Following a literature review, 20 parents whose babies previously cried excessively took part in focus groups or interviews. They provided reports on their experiences and the supports they would have liked when their baby was crying excessively. In addition, they identified their preferred delivery methods and devices for accessing information and rated four example support packages identified by the literature review.FindingsDuring the period their baby cried excessively, most parents visited a health service professional and most considered these direct contacts to have provided helpful information and support. Websites were similarly popular. Telephones and tablets were the preferred means of accessing online information. Groups to meet other parents were considered an important additional resource by all the parents. Three package elements - a Surviving Crying website, a printed version of the website and a programme of Cognitive Behaviour Therapy-based support sessions delivered to parents by a qualified practitioner, were developed for further evaluation.

Pilot study of a social network intervention for heroin users in opiate substitution treatment: study protocol for a randomized controlled trial.

BACKGROUND: Research indicates that 3% of people receiving opiate substitution treatment (OST) in the UK manage to achieve abstinence from all prescribed and illicit drugs within 3 years of commencing treatment, and there is concern that treatment services have become skilled at engaging people but not at helping them to enter a stage of recovery and drug abstinence. The National Treatment Agency for Substance Misuse recommends the involvement of families and wider social networks in supporting drug users' psychological treatment, and this pilot randomized controlled trial aims to evaluate the impact of a social network-focused intervention for patients receiving OST. METHODS AND DESIGN: In this two-site, early phase, randomized controlled trial, a total of 120 patients receiving OST will be recruited and randomized to receive one of three treatments: 1) Brief Social Behavior and Network Therapy (B-SBNT), 2) Personal Goal Setting (PGS) or 3) treatment as usual. Randomization will take place following baseline assessment. Participants allocated to receive B-SBNT or PGS will continue to receive the same treatment that is routinely provided by drug treatment services, plus four additional sessions of either intervention. Outcomes will be assessed at baseline, 3 and 12 months. The primary outcome will be assessment of illicit heroin use, measured by both urinary analysis and self-report. Secondary outcomes involve assessment of dependence, psychological symptoms, social satisfaction, motivation to change, quality of life and therapeutic engagement. Family members (n = 120) of patients involved in the trial will also be assessed to measure the level of symptoms, coping and the impact of the addiction problem on the family member at baseline, 3 and 12 months. DISCUSSION: This study will provide experimental data regarding the feasibility and efficacy of implementing a social network intervention within routine drug treatment services in the UK National Health Service. The study will explore the impact of the intervention on both patients receiving drug treatment and their family members. TRIAL REGISTRATION NUMBER: ISRCTN22608399. ISRCTN22608399 registration: 27/04/2012. Date of first randomisation: 14/08/2012.