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1.  Development of a composite outcome score for a complex intervention - measuring the impact of Community Health Workers 
Trials  2015;16:107.
In health services research, composite scores to measure changes in health-seeking behaviour and uptake of services do not exist. We describe the rationale and analytical considerations for a composite primary outcome for primary care research. We simulate its use in a large hypothetical population and use it to calculate sample sizes. We apply it within the context of a proposed cluster randomised controlled trial (RCT) of a Community Health Worker (CHW) intervention.
We define the outcome as the proportion of the services (immunizations, screening tests, stop-smoking clinics) received by household members, of those that they were eligible to receive. First, we simulated a population household structure (by age and sex), based on household composition data from the 2011 England and Wales census. The ratio of eligible to received services was calculated for each simulated household based on published eligibility criteria and service uptake rates, and was used to calculate sample size scenarios for a cluster RCT of a CHW intervention. We assume varying intervention percentage effects and varying levels of clustering.
Assuming no disease risk factor clustering at the household level, 11.7% of households in the hypothetical population of 20,000 households were eligible for no services, 26.4% for 1, 20.7% for 2, 15.3% for 3 and 25.8% for 4 or more. To demonstrate a small CHW intervention percentage effect (10% improvement in uptake of services out of those who would not otherwise have taken them up, and additionally assuming intra-class correlation of 0.01 between households served by different CHWs), around 4,000 households would be needed in each of the intervention and control arms. This equates to 40 CHWs (each servicing 100 households) needed in the intervention arm. If the CHWs were more effective (20%), then only 170 households would be needed in each of the intervention and control arms.
This is a useful first step towards a process-centred composite score of practical value in complex community-based interventions. Firstly, it is likely to result in increased statistical power compared with multiple outcomes. Second, it avoids over-emphasis of any single outcome from a complex intervention.
PMCID: PMC4417521  PMID: 25872945
Health services research; Health impact assessment; Delivery of health care; Research outcomes
2.  A methodological systematic review of what’s wrong with meta-ethnography reporting 
Syntheses of qualitative studies can inform health policy, services and our understanding of patient experience. Meta-ethnography is a systematic seven-phase interpretive qualitative synthesis approach well-suited to producing new theories and conceptual models. However, there are concerns about the quality of meta-ethnography reporting, particularly the analysis and synthesis processes. Our aim was to investigate the application and reporting of methods in recent meta-ethnography journal papers, focusing on the analysis and synthesis process and output.
Methodological systematic review of health-related meta-ethnography journal papers published from 2012–2013. We searched six electronic databases, Google Scholar and Zetoc for papers using key terms including ‘meta-ethnography.’ Two authors independently screened papers by title and abstract with 100% agreement. We identified 32 relevant papers. Three authors independently extracted data and all authors analysed the application and reporting of methods using content analysis.
Meta-ethnography was applied in diverse ways, sometimes inappropriately. In 13% of papers the approach did not suit the research aim. In 66% of papers reviewers did not follow the principles of meta-ethnography. The analytical and synthesis processes were poorly reported overall. In only 31% of papers reviewers clearly described how they analysed conceptual data from primary studies (phase 5, ‘translation’ of studies) and in only one paper (3%) reviewers explicitly described how they conducted the analytic synthesis process (phase 6). In 38% of papers we could not ascertain if reviewers had achieved any new interpretation of primary studies. In over 30% of papers seminal methodological texts which could have informed methods were not cited.
We believe this is the first in-depth methodological systematic review of meta-ethnography conduct and reporting. Meta-ethnography is an evolving approach. Current reporting of methods, analysis and synthesis lacks clarity and comprehensiveness. This is a major barrier to use of meta-ethnography findings that could contribute significantly to the evidence base because it makes judging their rigour and credibility difficult. To realise the high potential value of meta-ethnography for enhancing health care and understanding patient experience requires reporting that clearly conveys the methodology, analysis and findings. Tailored meta-ethnography reporting guidelines, developed through expert consensus, could improve reporting.
Electronic supplementary material
The online version of this article (doi:10.1186/1471-2288-14-119) contains supplementary material, which is available to authorized users.
PMCID: PMC4277825  PMID: 25407140
Meta-ethnography; Systematic review; Qualitative health research; Reporting; Qualitative synthesis; Health; Evidence-based practice
3.  An ongoing struggle: a mixed-method systematic review of interventions, barriers and facilitators to achieving optimal self-care by children and young people with Type 1 Diabetes in educational settings 
BMC Pediatrics  2014;14:228.
Type 1 diabetes occurs more frequently in younger children who are often pre-school age and enter the education system with diabetes-related support needs that evolve over time. It is important that children are supported to optimally manage their diet, exercise, blood glucose monitoring and insulin regime at school. Young people self-manage at college/university.
Theory-informed mixed-method systematic review to determine intervention effectiveness and synthesise child/parent/professional views of barriers and facilitators to achieving optimal diabetes self-care and management for children and young people age 3–25 years in educational settings.
Eleven intervention and 55 views studies were included. Meta-analysis was not possible. Study foci broadly matched school diabetes guidance. Intervention studies were limited to specific contexts with mostly high risk of bias. Views studies were mostly moderate quality with common transferrable findings.
Health plans, and school nurse support (various types) were effective. Telemedicine in school was effective for individual case management. Most educational interventions to increase knowledge and confidence of children or school staff had significant short-term effects but longer follow-up is required. Children, parents and staff said they struggled with many common structural, organisational, educational and attitudinal school barriers. Aspects of school guidance had not been generally implemented (e.g. individual health plans). Children recognized and appreciated school staff who were trained and confident in supporting diabetes management.
Research with college/university students was lacking. Campus-based college/university student support significantly improved knowledge, attitudes and diabetes self-care. Self-management was easier for students who juggled diabetes-management with student lifestyle, such as adopting strategies to manage alcohol consumption.
This novel mixed-method systematic review is the first to integrate intervention effectiveness with views of children/parents/professionals mapped against school diabetes guidelines. Diabetes management could be generally improved by fully implementing and auditing guideline impact. Evidence is limited by quality and there are gaps in knowledge of what works. Telemedicine between healthcare providers and schools, and school nurse support for children is effective in specific contexts, but not all education systems employ onsite nurses. More innovative and sustainable solutions and robust evaluations are required. Comprehensive lifestyle approaches for college/university students warrant further development and evaluation.
Electronic supplementary material
The online version of this article (doi:10.1186/1471-2431-14-228) contains supplementary material, which is available to authorized users.
PMCID: PMC4263204  PMID: 25213220
Systematic review; Diabetes Type 1; Children; Adolescent; Young Person; Educational setting; School; University; College; School nurse
4.  Wheelchair interventions, services and provision for disabled children: a mixed-method systematic review and conceptual framework 
Wheelchairs for disabled children (≤18 years) can provide health, developmental and social benefits. World Health Organisation and United Kingdom Government reports demonstrate the need for improved access to wheelchairs both locally and internationally. The use of health economics within this field is lacking. Provision of wheelchairs based on cost-effectiveness evidence is not currently possible. We conducted the first systematic review in this field to incorporate evidence of effectiveness, service user perspectives, policy intentions and cost-effectiveness in order to develop a conceptual framework to inform future research and service development.
We used an adapted EPPI-Centre mixed-method systematic review design with narrative summary, thematic and narrative synthesis. 11 databases were searched. Studies were appraised for quality using one of seven appropriate tools. A conceptual framework was developed from synthesised evidence.
22 studies and 14 policies/guidelines were included. Powered wheelchairs appear to offer benefits in reduced need for caregiver assistance; improved communicative, personal-social and cognitive development; and improved mobility function and independent movement. From 14 months of age children can learn some degree of powered wheelchair driving competence. However, effectiveness evidence was limited and low quality. Children and parents placed emphasis on improving social skill and independence. Participation in wider society and development of meaningful relationships were key desired outcomes. Policy intentions and aspirations are in line with the perspectives of children and parents, although translation of policy recommendations into practice is lacking.
There is a distinct lack of high quality effectiveness and economic evidence in this field. Social and health needs should be seen as equally important when assessing the mobility needs of disabled children. Disabled children and parents placed highest priority on independence and psychosocial outcomes of wheelchair interventions. Translation of policy and guidelines into practice is lacking and more effective implementation strategies are required to improve services and outcomes. Future research should focus on outcome measure development, developing economic evaluation tools and incorporating these into high quality studies to address known research gaps. The novel conceptual framework maps current gaps in evidence and outlines areas for development.
PMCID: PMC4110242  PMID: 25034517
Wheelchair; Childhood disability; Assistive mobility technology; Children; Powered wheelchair; Systematic review; Conceptual framework; Health economics
5.  When to stop? Decision-making when children’s cancer treatment is no longer curative: a mixed-method systematic review 
BMC Pediatrics  2014;14:124.
Children with cancer, parents, and clinicians, face difficult decisions when cure is no longer possible. Little is known about decision-making processes, how agreement is reached, or perspectives of different actors. Professionals voice concerns about managing parental expectations and beliefs, which can be contrary to their own and may change over time. We conducted the first systematic review to determine what constitutes best medico-legal practice for children under 19 years as context to exploring the perspectives of actors who make judgements and decisions when cancer treatment is no longer curative.
Theory-informed mixed-method thematic systematic review with theory development.
Eight legal/ethical guidelines and 18 studies were included. Whilst there were no unresolved dilemmas, actors had different perspectives and motives. In line with guidelines, the best interests of the individual child informed decisions, although how different actors conceptualized ‘best interests’ when treatment was no longer curative varied. Respect for autonomy was understood as following child/parent preferences, which varied from case to case. Doctors generally shared information so that parents alone could make an informed decision. When parents received reliable information, and personalized interest in their child, they were more likely to achieve shared trust and clearer transition to palliation. Although under-represented in research studies, young people’s perspectives showed some differences to those of parents and professionals. For example, young people preferred to be informed even when prognosis was poor, and they had an altruistic desire to help others by participating in research.
There needs to be fresh impetus to more effectively and universally implement the ethics of professionalism into daily clinical practice in order to reinforce humanitarian attitudes. Ethical guidelines and regulations attempt to bring professionals together by articulating shared values. While important, ethics training must be supported by institutions/organizations to assist doctors to maintain good professional standards. Findings will hopefully stimulate further normative and descriptive lines of research in this complex under-researched field. Future research needs to be undertaken through a more deliberative cultural lens that includes children’s and multi-disciplinary team members’ perspectives to more fully characterize and understand the dynamics of the decision-making process in this specific end-of life context.
PMCID: PMC4028290  PMID: 24884514
Cancer; Palliative care; Children; Young people; Parents; Professional; End-of-life; Decision-making; Systematic review
6.  Celebrating methodological challenges and changes: reflecting on the emergence and importance of the role of qualitative evidence in Cochrane reviews 
Systematic Reviews  2013;2:84.
Cochrane systematic reviews have proven to be beneficial for decision making processes, both on a practitioner and a policy level, and there are current initiatives to extend the types of evidence used by them, including qualitative research. In this article we outline the major achievements of the Cochrane Qualitative and Implementation Methods Group. Although the Group has encountered numerous challenges in dealing with the evolution of qualitative evidence synthesis, both outside and within the Cochrane Collaboration, it has successfully responded to the challenges posed in terms of incorporating qualitative evidence in systematic reviews. The Methods Group will continue to advocate for more flexible and inclusive approaches to evidence synthesis in order to meet the exciting challenges and opportunities presented by mixed methods systematic reviews and reviews of complex interventions.
PMCID: PMC3853345  PMID: 24135194
Systematic reviews; Qualitative research; Qualitative evidence synthesis
7.  Effective process or dangerous precipice: qualitative comparative embedded case study with young people with epilepsy and their parents during transition from children’s to adult services 
BMC Pediatrics  2013;13:169.
Transition from children’s to adult epilepsy services is known to be challenging. Some young people partially or completely disengage from contact with services, thereby risking their health and wellbeing. We conducted a mixed-method systematic review that showed current epilepsy transition models enabling information exchange and developing self-care skills were not working well. We used synthesised evidence to develop a theoretical framework to inform this qualitative study. The aim was to address a critical research gap by exploring communication, information needs, and experiences of knowledge exchange in clinical settings by young people and their parents, during transition from children’s to adult epilepsy services.
Qualitative comparative embedded Case study with 2 'transition’ cases (epilepsy services) in two hospitals. Fifty-eight participants: 30 young people (13–19 years) and 28 parents were interviewed in-depth (individual or focus group). Clinical documents/guidelines were collated. 'Framework’ thematic analysis was used. The theoretical framework was tested using themes, pattern matching and replication logic. Theory-based evaluation methods were used to understand how and why different models of service delivery worked.
A joint epilepsy clinic for young people 14–17 years coordinated by children’s and adult services was more likely to influence young people’s behaviour by facilitating more positive engagement with adult healthcare professionals and retention of epilepsy-related self-care information. Critical success factors were continuity of care, on-going and consistent age-appropriate and person centred communication and repeated information exchange. Three young people who experienced a single handover clinic disengaged from services. Psychosocial care was generally inadequate and healthcare professionals lacked awareness of memory impairment. Parents lacked knowledge, skills and support to enable their child to independently self-care. Translation of transition policies/guidelines into practice was weak.
Findings make a significant contribution to understanding why young people disengage from epilepsy services, why some parents prevent independent self-care, and what constitutes good communication and transition from the perspective of young people and parents. The type of service configuration, delivery and organisation influenced the behaviours of young people at transition to adult services. The novel theoretical framework was substantially supported, underwent further post-hoc development and can be used in future practice/intervention development and research.
PMCID: PMC4016204  PMID: 24131769
Young people; Parents; Epilepsy; Transition; Qualitative case-study; Theory-based evaluation; Communication; Information needs; Knowledge exchange; Epilepsy nurse specialist
8.  Learning from the Brazilian Community Health Worker Model in North Wales 
Health policymakers in many countries are looking at ways of increasing health care coverage by scaling up the deployment of community health workers. In this commentary, we describe the rationale for the UK to learn from Brazil’s scaled-up Community Health Worker primary care strategy, starting with a pilot project in North Wales.
PMCID: PMC3681592  PMID: 23764067
Community Health Worker; Reverse innovation; Primary care
9.  Evidence-based planning and costing palliative care services for children: novel multi-method epidemiological and economic exemplar 
BMC Palliative Care  2013;12:18.
Children’s palliative care is a relatively new clinical specialty. Its nature is multi-dimensional and its delivery necessarily multi-professional. Numerous diverse public and not-for-profit organisations typically provide services and support. Because services are not centrally coordinated, they are provided in a manner that is inconsistent and incoherent. Since the first children’s hospice opened in 1982, the epidemiology of life-limiting conditions has changed with more children living longer, and many requiring transfer to adult services. Very little is known about the number of children living within any given geographical locality, costs of care, or experiences of children with ongoing palliative care needs and their families. We integrated evidence, and undertook and used novel methodological epidemiological work to develop the first evidence-based and costed commissioning exemplar.
Multi-method epidemiological and economic exemplar from a health and not-for-profit organisation perspective, to estimate numbers of children under 19 years with life-limiting conditions, cost current services, determine child/parent care preferences, and cost choice of end-of-life care at home.
The exemplar locality (North Wales) had important gaps in service provision and the clinical network. The estimated annual total cost of current children’s palliative care was about £5.5 million; average annual care cost per child was £22,771 using 2007 prevalence estimates and £2,437- £11,045 using new 2012/13 population-based prevalence estimates. Using population-based prevalence, we estimate 2271 children with a life-limiting condition in the general exemplar population and around 501 children per year with ongoing palliative care needs in contact with hospital services. Around 24 children with a wide range of life-limiting conditions require end-of-life care per year. Choice of end-of-life care at home was requested, which is not currently universally available. We estimated a minimum (based on 1 week of end-of-life care) additional cost of £336,000 per year to provide end-of-life support at home. Were end-of-life care to span 4 weeks, the total annual additional costs increases to £536,500 (2010/11 prices).
Findings make a significant contribution to population-based needs assessment and commissioning methodology in children’s palliative care. Further work is needed to determine with greater precision which children in the total population require access to services and when. Half of children who died 2002-7 did not have conditions that met the globally used children's palliative care condition categories, which need revision in light of findings.
PMCID: PMC3651264  PMID: 23617814
Children; Palliative care; Life-limiting illness; Evidence-based; Commissioning framework; Health economics; Cost; Health services research
10.  Planning ahead with children with life-limiting conditions and their families: development, implementation and evaluation of ‘My Choices’ 
BMC Palliative Care  2013;12:5.
The United Kingdom has led the world in the development of children’s palliative care. Over the past two decades, the illness trajectories of children with life-limiting conditions have extended with new treatments and better home-based care. Future planning is a critically under-researched aspect of children’s palliative care globally. This paper describes the development, implementation and evaluation of innovative child and parent-held palliative care planning resources. The resources were designed to facilitate parent and child thinking and engagement in future planning, and to determine care preferences and preferred locations of care for children with life-limiting conditions from diagnosis onwards. These resources fill a significant gap in palliative care planning before the end-of-life phase.
Drawing on contemporaneous research on producing evidence-based children’s health information, we collaborated with leading children’s not-for-profit organisations, parents, children, and professionals. A set of resources (My Choices booklets) were developed for parents and children and evaluated using interviews (parents, children, professionals) and questionnaires (professionals) and an open web-based consultation.
Parents and children responded in three ways: Some used the booklets to produce detailed written plans with clear outcomes and ideas about how best to achieve desired outcomes. Others preferred to use the booklet to help them think about potential options. Remaining parents found it difficult to think about the future and felt there was no point because they perceived there to be no suitable local services. Professionals varied in confidence in their ability to engage with families to plan ahead and identified many challenges that prevented them from doing so. Few families shared their plans with professionals. Parents and children have far stronger preferences for home-care than professionals.
The My Choices booklets were revised in light of findings, have been endorsed by Together for Short Lives, and are free to download in English and Welsh for use by parents and young people globally. More work needs to be done to support families who are not yet receptive to planning ahead. Professionals would benefit from more training in person-centred approaches to future planning and additional communications skills to increase confidence and ability to engage with families to deliver sensitive palliative care planning.
PMCID: PMC3579717  PMID: 23384400
Children; Palliative care; Advance care planning; Nursing; Medicine; Evaluation
11.  Fatherhood and children with complex healthcare needs: qualitative study of fathering, caring and parenting 
BMC Nursing  2011;10:5.
Fathers are increasingly providing substantial amounts of technical and nursing care to growing numbers of children with complex healthcare needs. This exploratory study reports some of the first in-depth evidence of fathers' experiences and presents a research agenda in this critically under-researched area.
We conducted in-depth qualitative interviews with 8 fathers who provided a substantial amount of complex technical and nursing care for their child at home. The aim was to describe their experiences of fathering, parenting and caring. Interviews were recorded, transcribed and analysed using Burnard's approach, which has commonalities with phenomenological and content analysis.
Results and Discussion
Fathers enjoyed their caring role and found it rewarding and at times stressful. They instituted structured regimes, which focused on the father/child/family. Performing intimate care posed specific challenges for which there is no guidance. Children's community nursing was highly valued. Fathers generally rejected the need for specific father-focussed services, as such provision would induce guilt feelings. Fathers reported positive relationships with their children and partners.
Key areas for future exploration include gaining a better understanding of fathers' motivations and styles of caring, developing interventions to support fathers' caring role, developing guidance on intimate care, and delivering tailored services to fathers in a family context. There is little understanding of fathering and caring by non-resident, teenage and step-fathers. Finally, knowing more about resilience and coping of fathers in strong relationships with partners and children may help inform interventions to support fathers who do not feel able to stay with their family.
PMCID: PMC3094306  PMID: 21496238
Disabled children; complex continuing nursing care; fathers; community nursing; qualitative
12.  A methodological review of resilience measurement scales 
The evaluation of interventions and policies designed to promote resilience, and research to understand the determinants and associations, require reliable and valid measures to ensure data quality. This paper systematically reviews the psychometric rigour of resilience measurement scales developed for use in general and clinical populations.
Eight electronic abstract databases and the internet were searched and reference lists of all identified papers were hand searched. The focus was to identify peer reviewed journal articles where resilience was a key focus and/or is assessed. Two authors independently extracted data and performed a quality assessment of the scale psychometric properties.
Nineteen resilience measures were reviewed; four of these were refinements of the original measure. All the measures had some missing information regarding the psychometric properties. Overall, the Connor-Davidson Resilience Scale, the Resilience Scale for Adults and the Brief Resilience Scale received the best psychometric ratings. The conceptual and theoretical adequacy of a number of the scales was questionable.
We found no current 'gold standard' amongst 15 measures of resilience. A number of the scales are in the early stages of development, and all require further validation work. Given increasing interest in resilience from major international funders, key policy makers and practice, researchers are urged to report relevant validation statistics when using the measures.
PMCID: PMC3042897  PMID: 21294858
13.  Knowledge and information needs of young people with epilepsy and their parents: Mixed-method systematic review 
BMC Pediatrics  2010;10:103.
Young people with neurological impairments such as epilepsy are known to receive less adequate services compared to young people with other long-term conditions. The time (age 13-19 years) around transition to adult services is particularly important in facilitating young people's self-care and ongoing management. There are epilepsy specific, biological and psycho-social factors that act as barriers and enablers to information exchange and nurturing of self-care practices. Review objectives were to identify what is known to be effective in delivering information to young people age 13-19 years with epilepsy and their parents, to describe their experiences of information exchange in healthcare contexts, and to identify factors influencing positive and negative healthcare communication.
The Evidence for Policy and Practice Information Coordinating Centre systematic mixed-method approach was adapted to locate, appraise, extract and synthesise evidence. We used Ley's cognitive hypothetical model of communication and subsequently developed a theoretical framework explaining information exchange in healthcare contexts.
Young people and parents believed that healthcare professionals were only interested in medical management. Young people felt that discussions about their epilepsy primarily occurred between professionals and parents. Epilepsy information that young people obtained from parents or from their own efforts increased the risk of epilepsy misconceptions. Accurate epilepsy knowledge aided psychosocial adjustment. There is some evidence that interventions, when delivered in a structured psycho-educational, age appropriate way, increased young people's epilepsy knowledge, with positive trend to improving quality of life. We used mainly qualitative and mixed-method evidence to develop a theoretical framework explaining information exchange in clinical encounters.
There is a paucity of evidence reporting effective interventions, and the most effective ways of delivering information/education in healthcare contexts. No studies indicated if improvement was sustained over time and whether increased knowledge was effective in improving in self-care. Current models of facilitating information exchange and self-care around transition are not working well. There is an urgent need for further studies to develop and evaluate interventions to facilitate successful information exchange, and follow young people over time to see if interventions showing early promise are effective in the medium to long-term.
PMCID: PMC3022792  PMID: 21194484
14.  Evidence into practice: evaluating a child-centred intervention for diabetes medicine management The EPIC Project 
BMC Pediatrics  2010;10:70.
There is a lack of high quality, child-centred and effective health information to support development of self-care practices and expertise in children with acute and long-term conditions. In type 1 diabetes, clinical guidelines indicate that high-quality, child-centred information underpins achievement of optimal glycaemic control with the aim of minimising acute readmissions and reducing the risk of complications in later life. This paper describes the development of a range of child-centred diabetes information resources and outlines the study design and protocol for a randomized controlled trial to evaluate the information resources in routine practice. The aim of the diabetes information intervention is to improve children and young people's quality of life by increasing self-efficacy in managing their type 1 diabetes.
We used published evidence, undertook qualitative research and consulted with children, young people and key stakeholders to design and produce a range of child-centred, age-appropriate children's diabetes diaries, carbohydrate recording sheets, and assembled child-centred, age-appropriate diabetes information packs containing published information in a folder that can be personalized by children and young people with pens and stickers. Resources have been designed for children/young people 6-10; 11-15; and 16-18 years.
To evaluate the information resources, we designed a pragmatic randomized controlled trial to assess the effectiveness, cost effectiveness, and implementation in routine practice of individually tailored, age-appropriate diabetes diaries and information packs for children and young people age 6-18years, compared with currently available standard practice.
Children and young people will be stratified by gender, length of time since diagnosis (< 2years and > 2years) and age (6-10; 11-15; and 16-18 years). The following data will be collected at baseline, 3 and 6 months: PedsQL (generic, diabetes and parent versions), and EQ-5 D (parent and child); NHS resource use and process data (questionnaire and interview). Baseline and subsequent HbA1c measurements, blood glucose meter use, readings and insulin dose will be taken from routine test results and hand-held records when attending routine 3-4 monthly clinic visits.
The primary outcome measure is diabetes self-efficacy and quality-of-life (Diabetes PedsQL). Secondary outcomes include: HbA1c, generic quality of life, routinely collected NHS/child-held data, costs, service use, acceptability and utility.
Trial Registration
PMCID: PMC2955672  PMID: 20875112

Results 1-14 (14)