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BACKGROUND: Asthma is a common long-term condition and major public health problem. Supported self-management for asthma that includes a written personalised asthma action plan, supported by regular professional review, reduces unscheduled consultations and improves asthma outcomes and quality of life. However, despite unequivocal inter/national guideline recommendations, supported self-management is poorly implemented in practice. The IMPlementing IMProved Asthma self-management as RouTine (IMP2ART) implementation strategy has been developed to address this challenge. The aim of this implementation trial is to determine whether facilitated delivery of the IMP2ART strategy increases the provision of asthma action plans and reduces unscheduled care in the context of routine UK primary care.METHODS: IMP2ART is a parallel group, cluster randomised controlled hybrid II implementation trial. One hundred forty-four general practices will be randomly assigned to either the IMP2ART implementation strategy or control group. Following a facilitation workshop, implementation group practices will receive organisational resources to help them prioritise supported self-management (including audit and feedback; an IMP2ART asthma review template), training for professionals and resources to support patients to self-manage their asthma. The control group will continue with usual asthma care. The primary clinical outcome is the between-group difference in unscheduled care in the second year after randomisation (i.e. between 12 and 24 months post-randomisation) assessed from routine data. Additionally, a primary implementation outcome of asthma action plan ownership at 12 months will be assessed by questionnaire to a random sub-group of people with asthma. Secondary outcomes include the number of asthma reviews conducted, prescribing outcomes (reliever medication and oral steroids), asthma symptom control, patients' confidence in self-management and professional support and resource use. A health economic analysis will assess cost-effectiveness, and a mixed methods process evaluation will explore implementation, fidelity and adaptation.DISCUSSION: The evidence for supported asthma self-management is overwhelming. This study will add to the literature regarding strategies that can effectively implement supported self-management in primary care to reduce unscheduled consultations and improve asthma outcomes and quality of life.TRIAL REGISTRATION: ISRCTN15448074. Registered on 2 December 2019.

BackgroundThe short-term effectiveness (to 24 months post partum) of a preventative home-visiting intervention, the Family Nurse Partnership, was previously assessed in the Building Blocks trial (BB:0–2).ObjectivesThe objectives were to establish the medium-term effectiveness of the Family Nurse Partnership in reducing maltreatment and improving maternal health (second pregnancies) and child health, developmental and educational outcomes (e.g. early educational attendance, school readiness); to explore effect moderators and mediators; and to describe the costs of enhancing usually provided health and social care with the Family Nurse Partnership.DesignChildren and their mothers from an existing trial cohort were followed up using routine data until the child was 7 years of age.SettingThis study was set in 18 partnerships between local authorities and health-care organisations in England.ParticipantsThe participants were mothers [and their firstborn child(ren)] recruited as pregnant women aged ≤ 19 years, in local authority Family Nurse Partnership catchment areas, at InterventionsThe intervention comprised up to a maximum of 64 home visits by specially trained family nurses from early pregnancy until the firstborn child was 2 years of age, plus usually provided health and social care support. The comparator was usual care alone.Main outcome measuresThe primary outcome measure was child-in-need status recorded at any time during follow-up. The secondary outcomes were as follows: (1) referral to social services, child protection registration (plan), child-in-need categorisation, looked-after status, recorded injuries and ingestions at any time during follow-up; (2) early child care and educational attendance, school readiness (Early Years Foundation Stage Profile score) and attainment at Key Stage 1; and (3) health-care costs.Data sourcesThe following data sources were used: maternally reported baseline and follow-up data (BB:0–2), Hospital Episode Statistics data (NHS Digital), social care and educational data (National Pupil Database) and abortions data (Department of Health and Social Care).ResultsThere were no differences between study arms in the rates of referral to social services, being registered as a child in need, receiving child protection plans, entering care or timing of first referral for children subsequently assessed as in need. There were no differences between study arms in rates of hospital emergency attendance, admission for injuries or ingestions, or in duration of stay for admitted children. Children in the Family Nurse Partnership arm were more likely to achieve a good level of development at reception age (school readiness), an effect strengthened when adjusting for birth month. Differences at Key Stage 1 were not statistically different, but, after adjusting for birth month, children in the Family Nurse Partnership arm were more likely to reach the expected standard in reading. Programme effects were greater for boys (Key Stage 1: writing); children of younger mothers (Key Stage 1: writing, Key Stage 1: mathematics); and children of mothers not in employment, education or training at study baseline (Key Stage 1: writing). There were no differences between families who were part of the Family Nurse Partnership and those who were not for any other outcome. The differences between study arms in resource use and costs were negligible.LimitationsThe outcomes are constrained to those available from routine sources.ConclusionsThere is no observable benefit of the programme for maltreatment or maternal outcomes, but it does generate advantages in school readiness and attainment at Key Stage 1.Future workThe trajectory of longer-term programme benefits should be mapped using routine and participant-reported measures.FundingThis project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full inPublic Health Research; Vol. 9, No. 2. See the NIHR Journals Library website for further project information.

Background: Targeted therapies (TTs) have revolutionised cancer treatment with their enhanced specificity of action. Compared with conventional therapies, TTs are delivered over a longer period and often have unusual symptom profiles. Patient-reported outcome measures such as symptom side-effect lists need to be developed in a time-efficient manner to enable a rapid and full evaluation of new treatments and effective clinical management Objective: The aim of this study was to develop a set of TT-related symptoms and identify the optimal method for developing symptom lists. Patients and Methods: Symptoms from TT treatment in the context of Chronic Myeloid Leukaemia (CML), HER2-positive breast cancer, or Gastrointestinal Stromal Tumours (GIST) were identified through literature reviews, interviews with healthcare professionals (HCPs) and patients, and patient focus groups. The symptom set was then pilot tested in patients across the three cancer diagnoses: The number of items derived from each source (literature, patients, or HCPs) were compared. Results: A total of 316 patients and 86 HCPs from 16 countries participated. An initial set of 209 symptoms was reduced to 61 covering 12 symptom categories. Patient interviews made the greatest contribution to the item set. Conclusions: Symptom lists should be created based on input from patients. The item set described will be applicable to the assessment of new TTs, and in monitoring treatment.