"not one size fits all" The challenges of measuring paediatric health-related quality of life and the potential role of digital ecological momentary assessment: a qualitative study.

PURPOSE: To explore the views of clinicians and researchers about the challenges of measuring health-related quality of life (HRQoL) in children (5-11 years) and to explore whether digital ecological momentary assessment (EMA) could enhance HRQoL measurement. METHODS: Semi-structured qualitative interviews with 18 professionals (10 academics/researchers, four clinicians, four with both professional backgrounds) experienced in child HRQoL measurement. We analysed data thematically. RESULTS: Theme One describes the uncertainty around conceptualising HRQoL for children and which domains to include; the greater immediacy and sensitivity of children's reflections on their HRQoL, leading to high variability of the construct; and the wide individual differences across childhood, incongruent with fixed HRQoL measures. Theme Two describes the challenges of proxy reporting, questioning whether proxies can meaningfully report a child's HRQoL and reflecting on discrepancies between child and proxy reporting. Theme Three covers the challenge of interpreting change in HRQoL over time; does a change in HRQoL reflect a change in health, or does this reflect developmental changes in how children report HRQoL. Theme Four discusses digital EMA for HRQoL data capture. In-the-moment, repeated measurement could provide rich data and address challenges of recall, ecological validity and variability; passive data could provide objective markers to supplement subjective responses; and technology could enable personalisation and child-centred design. However, participants also raised methodological, practical and ethical challenges of digital approaches. CONCLUSION: Digital EMA may address some of the challenges of HRQoL data collection with children. We conclude by discussing potential future research to explore and develop this approach.

Graded exercise therapy compared to activity management for paediatric chronic fatigue syndrome/myalgic encephalomyelitis: pragmatic randomized controlled trial.

The MAGENTA pragmatic parallel groups randomized controlled trial compared graded exercise therapy (GET) with activity management (AM) in treating paediatric myalgic encephalomyelitis or chronic fatigue syndrome (ME/CFS). Children aged 8-17 years with mild/moderate ME/CFS and presenting to NHS specialist paediatric services were allocated at random to either individualised flexible treatment focussing on physical activity (GET, 123 participants) or on managing cognitive, school and social activity (AM, 118 participants) delivered by NHS therapists. The primary outcome was the self-reported short-form 36 physical function subscale (SF-36-PFS) after 6 months, with higher scores indicating better functioning. After 6 months, data were available for 201 (83%) participants who received a mean of 3.9 (GET) or 4.6 (AM) treatment sessions. Comparing participants with measured outcomes in their allocated groups, the mean SF-36-PFS score changed from 54.8 (standard deviation 23.7) to 55.7 (23.3) for GET and from 55.5 (23.1) to 57.7 (26.0) for AM giving an adjusted difference in means of -2.02 (95% confidence interval -7.75, 2.70). One hundred thirty-five participants completed the mean SF-36-PFS at 12 months, and whilst further improvement was observed, the difference between the study groups remained consistent with chance. The two study groups showed similar changes on most of the secondary outcome measures: Chalder Fatigue, Hospital Anxiety and Depression Scale: Depression, proportion of full-time school attended, a visual analogue pain scale, participant-rated change and accelerometer measured physical activity, whether at the 6-month or 12-month assessment. There was an isolated finding of some evidence of an improvement in anxiety in those allocated to GET, as measured by the Hospital Anxiety and Depression Scale at 6 months, with the 12-month assessment, and the Spence Children's Anxiety scale being aligned with that finding. There was weak evidence of a greater risk of deterioration with GET (27%) than with AM (17%; p = 0.069). At conventional UK cost per QALY thresholds, the probability that GET is more cost-effective than AM ranged from 18 to 21%. Whilst completion of the SF-36-PFS, Chalder Fatigue Scale and EQ-5D-Y was good at the 6-month assessment point, it was less satisfactory for other measures, and for all measures at the 12-month assessment.  Conclusion: There was no evidence that GET was more effective or cost-effective than AM in this setting, with very limited improvement in either study group evident by the 6-month or 12-month assessment points.  Trial registration: The study protocol was registered at www.isrctn.com (3rd September 2015; ISRCTN 23962803) before the start of enrolment to the initial feasibility phase.

Evaluating the Effectiveness of the SleepTracker App for Detecting Anxiety- and Depression-Related Sleep Disturbances.

This study emphasises the critical role of quality sleep in physical and mental well-being, exploring its impact on bodily recovery and cognitive function. Investigating poor sleep quality in approximately 40% of individuals with insomnia symptoms, the research delves into its potential diagnostic relevance for depression and anxiety, with a focus on intervention in mental health by understanding sleep patterns, especially in young individuals. This study includes an exploration of phone usage habits among young adults during PPI sessions, providing insights for developing the SleepTracker app. This pivotal tool utilises phone usage and movement data from mobile device sensors to identify indicators of anxiety or depression, with participant information organised comprehensively in a table categorising condition related to phone usage and movement data. The analysis compares this data with survey results, incorporating scores from the Sleep Condition Indicator (SCI), Patient Health Questionnaire-9 (PHQ-9), and Generalised Anxiety Disorder-7 (GAD-7). Generated confusion matrices offer a detailed overview of the relationship between sleep metrics, phone usage, and movement data. In summary, this study reveals the accurate detection of negative sleep disruption instances by the classifier. However, improvements are needed in identifying positive instances, reflected in the F1-score of 0.5 and a precision result of 0.33. While early intervention potential is significant, this study emphasises the need for a larger participant pool to enhance the model's performance.

Predictive model for long COVID in children 3 months after a SARS-CoV-2 PCR test.

BACKGROUND: To update and internally validate a model to predict children and young people (CYP) most likely to experience long COVID (i.e. at least one impairing symptom) 3 months after SARS-CoV-2 PCR testing and to determine whether the impact of predictors differed by SARS-CoV-2 status. METHODS: Data from a nationally matched cohort of SARS-CoV-2 test-positive and test-negative CYP aged 11-17 years was used. The main outcome measure, long COVID, was defined as one or more impairing symptoms 3 months after PCR testing. Potential pre-specified predictors included SARS-CoV-2 status, sex, age, ethnicity, deprivation, quality of life/functioning (five EQ-5D-Y items), physical and mental health and loneliness (prior to testing) and number of symptoms at testing. The model was developed using logistic regression; performance was assessed using calibration and discrimination measures; internal validation was performed via bootstrapping and the final model was adjusted for overfitting. RESULTS: A total of 7139 (3246 test-positives, 3893 test-negatives) completing a questionnaire 3 months post-test were included. 25.2% (817/3246) of SARS-CoV-2 PCR-positives and 18.5% (719/3893) of SARS-CoV-2 PCR-negatives had one or more impairing symptoms 3 months post-test. The final model contained SARS-CoV-2 status, number of symptoms at testing, sex, age, ethnicity, physical and mental health, loneliness and four EQ-5D-Y items before testing. Internal validation showed minimal overfitting with excellent calibration and discrimination measures (optimism-adjusted calibration slope: 0.96575; C-statistic: 0.83130). CONCLUSIONS: We updated a risk prediction equation to identify those most at risk of long COVID 3 months after a SARS-CoV-2 PCR test which could serve as a useful triage and management tool for CYP during the ongoing pandemic. External validation is required before large-scale implementation.

Loneliness and mental health in children and adolescents with pre-existing mental health problems: A rapid systematic review.

OBJECTIVES: Periods of social isolation are associated with loneliness in children and young people, and loneliness is associated with poor mental and physical health. Children and young people with pre-existing mental health difficulties may be prone to loneliness. Containment of COVID-19 has necessitated widespread social isolation, with unprecedented school closures and restrictions imposed on social interactions. This rapid review aimed to establish what is known about the relationship between loneliness and mental health problems in children and young people with pre-existing mental health problems. METHODS: We sought to identify all primary research that examined the cross-sectional and longitudinal associations between loneliness/perceived social isolation and mental health in children and young people with pre-existing mental health problems. We also aimed to identify effective interventions that reduce the adverse impact of loneliness. A rapid systematic search was conducted using MEDLINE, PsycINFO, and Web of Science. RESULTS: Of 4,531 papers screened, 15 included children and young people with pre-existing mental health conditions. These 15 studies included 1,536 children and young people aged between 6 and 23 years with social phobia, anxiety and/or depression, and neurodevelopmental disorders. Loneliness was associated with anxiety and depression both cross-sectionally and prospectively in children and young people with mental health problems and neurodevelopmental conditions. We found preliminary evidence that psychological treatments can help to reduce feelings of loneliness in this population. CONCLUSIONS: Loneliness is associated with depression and anxiety in children and young people with pre-existing mental health conditions, and this relationship may be bidirectional. Existing interventions to address loneliness and/or mental health difficulties in other contexts may be applied to this population, although they may need adaptation and testing in younger children and adolescents. PRACTITIONER POINTS: Loneliness is common in children and young people, and during periods of enforced social isolation such as during COVID-19, children and young people report high levels of loneliness (or increased rates of loneliness). The review showed that loneliness is associated, both cross-sectionally and prospectively, in children and young people with mental health problems and also in children and young people with neurodevelopmental conditions, such as autism spectrum disorder. Thus, loneliness is a possible risk factor of which mental health providers should be aware. Maintaining social contact both by direct and by indirect means, especially through the Internet, could be important in mitigating loneliness. Interventions to address loneliness should be further developed and tested to help children and young people with pre-existing mental health problems who are lonely by preventing exacerbation of their mental health difficulties, in particular anxiety and depression.

"it's a medical condition you need to support as much as possible": a qualitative analysis of teachers' experiences of chronic fatigue syndrome / myalgic encephalomyelitis (CFS/ME).

BACKGROUND: An increasing number of children with complex health needs are being educated in mainstream classes. CFS/ME is a complex and disabling condition, and there is little guidance on how primary school teachers can support younger children with this condition. To improve care, it is important to understand what these children need in the school setting, and the barriers and facilitators to teachers providing this support. The aims for this qualitative study were to explore teachers' views about CFS/ME, their experiences of supporting a pupil with CFS/ME and their perspectives on the barriers and facilitators to providing support. METHODS: We recruited families from an NHS specialist paediatric CFS/ME service and families were eligible if the child was aged between 5 and 11 years and had a diagnosis of CFS/ME. We gained written consent/assent from families to invite the child's teacher to participate in a qualitative interview. We contacted these teachers, gained written consent and then carried out semi-structured qualitative interviews. Interviews were audio-recorded, transcribed, anonymised and analysed thematically. Interviews took place between July 2018 and December 2018. RESULTS: We interviewed 11 teachers; their pupil's age ranged from 5 to 11 years and school attendance ranged from 0 to 80%. Theme 1: Most teachers provided rich descriptions of their pupil's CFS/ME; they consistently described cognitive dysfunction and significant fatigue, but beyond this the symptoms varied from one account to the next (from mobility problems, to aches and pains, digestive problems, headaches, nausea and hypersensitivity). These teachers noted the ripple effects on their pupil's social, emotional and academic functioning. Two of the eleven teachers said that they did not observe symptoms of CFS/ME, expressing a degree of scepticism about the diagnosis. Theme 2: Teachers described a close relationship with their pupil. They said they understood the individual needs of the child and portrayed positive and proactive attitudes towards providing support. The type of support provided included facilitating rest breaks and limiting strenuous activities; using practical strategies to address cognitive, physical, social and emotional difficulties; maintaining a connection with the child during their absences from school; and encouraging the child to talk about their health and wellbeing. Teachers noted that receiving formal confirmation of the child's diagnosis enabled them to put this support in place. Theme 3: The adaptations they described were often intuitive, rather than being based on a knowledge of CFS/ME. Teachers wanted more resources to increase their understanding of the condition and its management. CONCLUSIONS: Primary school teachers want to provide effective support for children with CFS/ME. Clinical services should consider working in collaboration with teachers to equip them with evidence-based strategies for CFS/ME management in the primary school setting.

How common are depression and anxiety in adolescents with chronic fatigue syndrome (CFS) and how should we screen for these mental health co-morbidities? A clinical cohort study.

Adolescents with Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME) appear to be more likely to experience anxiety and/or depression using Patient Reported Outcome Measures (PROMs). However, we do not know how accurate these are at detecting problems in this patient group given the primary symptom of fatigue. We aimed to accurately determine the prevalence of anxiety/depression using gold-standard diagnostic interviews and evaluate the accuracy of PROMs measuring mood disorders in this patient group. We conducted a cross-sectional epidemiological study in a specialist tertiary paediatric CFS/ME service, England. The participants were164 12-18-year olds with clinician confirmed CFS/ME and their parents. The measures were a semi-structured diagnostic interview, the Kiddie Schedule for Affective Disorders and Schizophrenia, K-SADS, and questionnaires (Revised Children's Anxiety and Depression Scale, RCADS; Spence Children's Anxiety Scale, SCAS; Hospital Anxiety and Depression Scale, HADS). Parents completed the RCADS-P. 35% met the criteria for at least one common mental health problem. 20% had major depressive disorder, and 27% an anxiety disorder, with social anxiety and generalised anxiety being the most common. There was high co-morbidity, with 61% of those who were depressed also having at least one anxiety disorder. The questionnaires were moderately accurate (AUC > 0.7) at detecting clinically significant anxiety/depression, although only the RCADS-anxiety reached the predefined 0.8 sensitivity, 0.7 specificity target. Mental health problems are particularly common amongst adolescents with CFS/ME. Most screening tools were not sufficiently accurate in detecting clinically significant anxiety and depression, so these should be used with care in combination with thorough psychological/psychiatric assessment.

"Crazy person is crazy person. It doesn't differentiate": an exploration into Somali views of mental health and access to healthcare in an established UK Somali community.

BACKGROUND: Mental health conditions have been shown to disproportionately affect those from Black, Asian and Minority Ethnic (BAME) communities. Somali communities globally have relatively high levels of mental illness, but low levels of mental health service use, with numerous barriers to care identified. This study was conducted in an established UK Somali community in the South West of England and aimed to explore community beliefs and views about the causes of mental illness, treatment for mental illness, and access to medical services in general. Participants were asked about how mental health and illness are understood and conceptualised, along with the cultural meaning of mental illness and its manifestations in relation to men, women and young people. DESIGN: Using a community-based participatory research design, in partnership with local Somali community organisations, the research team conducted four focus groups with a total of 23 participants aged over 18. Open-ended questions were used to facilitate discussion. Transcripts were analysed thematically. RESULTS: The participants discussed the role of migration and associated stress from the civil war and how that could contribute to mental illness. Participants tended to view the symptoms of mental illness as physical manifestations such as headaches and to describe a strong community stigma where those with mental health conditions were viewed as "crazy" by others. Barriers to accessing healthcare included language barriers, waiting times and a mistrust of doctors. Various ideas for improvements were discussed, including ideas to reduce stigma and ideas for community initiatives. CONCLUSION: Cultural considerations and reducing stigma are vital in improving understanding of mental illness and improving access to mental health services, along with building relationships and trust between the Somali community and health care workers.

Development of a conceptual framework to underpin a health-related quality of life outcome measure in paediatric chronic fatigue syndrome/myalgic encephalopathy (CFS/ME): prioritisation through card ranking.

PURPOSE: Chronic fatigue syndrome (CFS)/myalgic encephalopathy (ME) is relatively common in children and is disabling at an important time in their development. This study aimed to develop a conceptual framework of paediatric CFS/ME using the patient-perspective to ensure that the content of a new outcome measure includes the outcomes most important to young people. METHODS: We developed a child-centred interactive card ranking exercise that included health-related quality of life (HRQoL) outcomes identified from a previous review of the literature as well as qualitative work. Adolescents and their parents selected and ranked the outcomes most important to them and discussed each outcome in further detail. Adolescents were purposively sampled from a single specialist paediatric CFS/ME service in England. Interviews were audio recorded and transcribed verbatim, and thematic framework analysis was used to develop the final conceptual framework. RESULTS: We interviewed 43 participants in which there are 21 adolescents, 12-17 years of age with mild-moderate CFS/ME and their parents (20 mothers and 2 fathers). 'Symptoms', 'tiredness', 'payback and crashing' and 'activities and hobbies' were ranked most important to improve by both children and parents. Children ranked 'school' higher than parents and parents ranked 'mood' higher than children. A youth- specific CFS/ME conceptual framework of HRQoL was produced that included 4 outcome domains and 11 subdomains: sleep, tiredness, problems concentrating, individual symptoms, fluctuation and payback, daily and general activities, participation in school, leisure and social life, mood, anxiety and self-esteem. CONCLUSIONS: An interactive card ranking exercise worked well for adolescents aged 12-17 to elicit the most important outcomes to them and explore each domain in further detail. We developed a final conceptual framework of HRQoL that forms the basis of a new paediatric patient-reported outcome measure (PROM) in CFS/ME.

Enhancing communication, informed consent and recruitment in a paediatric urgent care surgical trial: a qualitative study.

BACKGROUND: Recruiting patients to paediatric trials can be challenging, especially in trials that compare markedly different management pathways and are conducted in acute settings. We aimed to enhance informed consent and recruitment in the CONTRACT trial (CONservative TReatment of Appendicitis in Children a randomised controlled Trial; ISRCTN15830435) - a feasibility trial that compared non-operative treatment (antibiotics) versus appendicectomy for uncomplicated acute appendicitis. METHODS: Qualitative study embedded within CONTRACT and conducted across three UK children's hospitals. Data were transcribed audio-recordings of 85 CONTRACT recruitment consultations with 58 families; and semi-structured interviews with 35 health professionals and 28 families (34 parents, 14 children) invited to participate in CONTRACT. Data analysis drew on thematic approaches. Throughout CONTRACT, we used findings from the ongoing qualitative analysis to inform bespoke communication training for health professionals recruiting to CONTRACT. Before and after training we also examined qualitative changes in communication during consultations and quantitative changes in recruitment rates. RESULTS: Bespoke communication training focussed on presenting the trial arms in a balanced way, emphasising clinical equipoise, exploring family treatment preferences and managing families' expectations about the trial's treatment pathways. Analysis of recruitment consultations indicated that health professionals' presentation of treatment arms became increasingly balanced following training, (e.g. avoiding imbalanced terminology) and recruitment rose from 38 to 62%. However, they remained reluctant to explore families' treatment preferences and respond with further information to balance these preferences. Analyses of interviews identified the time constraints of the urgent care setting, concerns about coercion, and reservations about exposing children to conversations about treatment risks as reasons for this reluctance. Interviews with families indicated the importance of clear explanations of trial treatment timings and sensitive communication of treatment allocation for both recruitment and retention. CONCLUSIONS: Following bespoke training based on the qualitative analyses, health professionals presented CONTRACT to families in clearer and more balanced ways and this was associated with an increase in the recruitment rate. Despite training, health professionals remained reluctant to explore families' treatment preferences. We provide several recommendations to enhance communication, informed consent, recruitment and retention in future trials in urgent care settings.

Digital Behavior Change Interventions for Younger Children With Chronic Health Conditions: Systematic Review.

BACKGROUND: The prevalence of chronic health conditions in childhood is increasing, and behavioral interventions can support the management of these conditions. Compared with face-to-face treatment, the use of digital interventions may be more cost-effective, appealing, and accessible, but there has been inadequate attention to their use with younger populations (children aged 5-12 years). OBJECTIVE: This systematic review aims to (1) identify effective digital interventions, (2) report the characteristics of promising interventions, and (3) describe the user's experience of the digital intervention. METHODS: A total of 4 databases were searched (Excerpta Medica Database [EMBASE], PsycINFO, Medical Literature Analysis and Retrieval System Online [MEDLINE], and the Cochrane Library) between January 2014 and January 2019. The inclusion criteria for studies were as follows: (1) children aged between 5 and 12 years, (2) interventions for behavior change, (3) randomized controlled trials, (4) digital interventions, and (5) chronic health conditions. Two researchers independently double reviewed papers to assess eligibility, extract data, and assess quality. RESULTS: Searches run in the databases identified 2643 papers. We identified 17 eligible interventions. The most promising interventions (having a beneficial effect and low risk of bias) were 3 targeting overweight or obesity, using exergaming or social media, and 2 for anxiety, using web-based cognitive behavioral therapy (CBT). Characteristics of promising interventions included gaming features, therapist support, and parental involvement. Most were purely behavioral interventions (rather than CBT or third wave), typically using the behavior change techniques (BCTs) feedback and monitoring, shaping knowledge, repetition and substitution, and reward. Three papers included qualitative data on the user's experience. We developed the following themes: parental involvement, connection with a health professional is important for engagement, technological affordances and barriers, and child-centered design. CONCLUSIONS: Of the 17 eligible interventions, digital interventions for anxiety and overweight or obesity had the greatest promise. Using qualitative methods during digital intervention development and evaluation may lead to more meaningful, usable, feasible, and engaging interventions, especially for this underresearched younger population. The following characteristics could be considered when developing digital interventions for younger children: involvement of parents, gaming features, additional therapist support, behavioral (rather than cognitive) approaches, and particular BCTs (feedback and monitoring, shaping knowledge, repetition and substitution, and reward). This review suggests a model for improving the conceptualization and reporting of behavioral interventions involving children and parents.

Recruiting Adolescents With Chronic Fatigue Syndrome/Myalgic Encephalomyelitis to Internet-Delivered Therapy: Internal Pilot Within a Randomized Controlled Trial.

BACKGROUND: Chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) in adolescents is common and disabling. Teenagers in the United Kingdom are more likely to recover if they access specialist care, but most do not have access to a local specialist CFS/ME service. Delivering treatment remotely via the internet could improve access to treatment. OBJECTIVE: This study aims to assess (1) the feasibility of recruitment and retention into a trial of internet-delivered specialist treatment for adolescents with CFS/ME and (2) the acceptability of trial processes and 2 web-based treatments (to inform continuation to full trial). METHODS: This study is an internal pilot for the initial 12 months of a full randomized controlled trial (RCT), with integrated qualitative methods (analysis of recruitment consultations and participant and clinician interviews). Recruitment and treatment were delivered remotely from a specialist pediatric CFS/ME treatment service within a hospital in South West United Kingdom. Adolescents (aged 11-17 years) from across the United Kingdom with a diagnosis of CFS/ME and no access to local specialist treatment were referred by their general practitioner to the treatment center. Eligibility assessment and recruitment were conducted via remote methods (telephone and on the web), and participants were randomized (via a computer-automated system) to 1 of 2 web-based treatments. The trial intervention was Fatigue in Teenagers on the InterNET in the National Health Service, a web-based modular CFS/ME-specific cognitive behavioral therapy program (designed to be used by young people and their parents or caregivers) supported by individualized clinical psychologist electronic consultations (regular, scheduled therapeutic message exchanges between participants and therapist within the platform). The comparator was Skype-delivered activity management with a CFS/ME clinician (mainly a physiotherapist or occupational therapist). Both treatments were intended to last for up to 6 months. The primary outcomes were (1) the number of participants recruited (per out-of-area referrals received between November 1, 2016, to October 31, 2017) and the proportion providing 6-month outcome data (web-based self-report questionnaire assessing functioning) and (2) the qualitative outcomes indicating the acceptability of trial processes and treatments. RESULTS: A total of 89 out of 150 (59.3% of potentially eligible referrals) young people and their parents or caregivers were recruited, with 75 out of 89 (84.2%) providing 6-month outcome data. Overall, web-based treatment was acceptable; however, participants and clinicians described both the advantages and disadvantages of remote methods. No serious adverse events were reported. CONCLUSIONS: Recruiting young people (and their parents or caregivers) into an RCT of web-based treatment via remote methods is feasible and acceptable. Delivering specialist treatment at home via the internet is feasible and acceptable, although some families prefer to travel across the United Kingdom for face-to-face treatment. TRIAL REGISTRATION: ISRCTN 18020851; http://www.isrctn.com/ISRCTN18020851. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-018-2500-3.

Can linguistic analysis be used to identify whether adolescents with a chronic illness are depressed?

Comorbid depression is common in adolescents with chronic illness. We aimed to design and test a linguistic coding scheme for identifying depression in adolescents with chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME), by exploring features of e-consultations within online cognitive behavioural therapy treatment. E-consultations of 16 adolescents (aged 11-17) receiving FITNET-NHS (Fatigue in teenagers on the interNET in the National Health Service) treatment in a national randomized controlled trial were examined. A theoretically driven linguistic coding scheme was developed and used to categorize comorbid depression in e-consultations using computerized content analysis. Linguistic coding scheme categorization was subsequently compared with classification of depression using the Revised Children's Anxiety and Depression Scale published cut-offs (t-scores ≥65, ≥70). Extra linguistic elements identified deductively and inductively were compared with self-reported depressive symptoms after unblinding. The linguistic coding scheme categorized three (19%) of our sample consistently with self-report assessment. Of all 12 identified linguistic features, differences in language use by categorization of self-report assessment were found for "past focus" words (mean rank frequencies: 1.50 for no depression, 5.50 for possible depression, and 10.70 for probable depression; p < .05) and "discrepancy" words (mean rank frequencies: 16.00 for no depression, 11.20 for possible depression, and 6.40 for probable depression; p < .05). The linguistic coding profile developed as a potential tool to support clinicians in identifying comorbid depression in e-consultations showed poor value in this sample of adolescents with CFS/ME. Some promising linguistic features were identified, warranting further research with larger samples.

Obstacles to recruitment in paediatric studies focusing on mental health in a physical health context: the experiences of clinical gatekeepers in an observational cohort study.

BACKGROUND: Studies in both paediatric and psychiatric settings often experience problems in recruitment. This can compromise the ability of the study to recruit to target, meaning studies are potentially underpowered. It can also result in a biased sample if a non-representative group are selectively recruited. Recruitment to studies in health contexts often depends on healthcare professionals, who act as gatekeepers by screening patients for eligibility and obtaining consent for the research team to contact them. The experience of health professionals as gatekeepers in paediatric studies is poorly understood and may affect whether recruitment is successful or not. METHODS: Six out of seven eligible healthcare professionals from a specialist paediatric chronic fatigue syndrome (CFS) team were interviewed. All participants were undertaking initial clinical assessments within which they were asked to identify eligible patients for an observational study of co-morbid mental health problems in adolescents with confirmed CFS/ME. This study had experienced particular recruitment problems, more so than other studies in the same service. Interview questions were designed to explore perceptions of research, and barriers and facilitators of recruitment. Interviews were audio recorded and transcribed verbatim. Thematic analysis was used. RESULTS: Participants espoused their commitment to the value of research. However, they perceived there to be a number of barriers to recruitment. Barriers within the clinical context included time pressures and the emotional nature of initial clinical assessments. Barriers posed by the wider research context included recruiting to multiple studies at the same time. Factors specific to the observational study of mental health in CFS/ME included aspects of the study design, such as the name and nature of the study, as well as the focus of the study itself. Participants made a number of recommendations about how recruitment barriers could be overcome. CONCLUSIONS: The current study highlights the need to carefully consider, at design stage, how to overcome potential barriers to recruitment. Gatekeepers should be actively involved at this stage to ensure that the study is set up in such a way to best enable recruitment activities within the clinical setting.

Depressive symptoms at age 9-13 and chronic disabling fatigue at age 16: A longitudinal study.

INTRODUCTION: We investigated whether depressive symptoms at ages 9-13 years were associated with chronic disabling fatigue (CDF) at age 16 among children in the Avon Longitudinal Study of Parents & Children (ALSPAC) birth cohort. METHODS: Depressive symptoms at ages 9, 10, 11, 12, and 13 years were defined as a child- or parent-completed Short Mood and Feelings Questionnaire (SMFQ) score ≥11 (range 0-26). SMFQ score was also analysed as a continuous exposure. Chronic disabling fatigue at 16 was defined as fatigue of ≥6 months' but <5 years' duration which prevented school attendance or activities, for which other causes were not identified, and with a Chalder Fatigue Questionnaire score ≥19. Logistic regression was used with multiple imputation to correct for missing data bias. We performed sensitivity analyses in which children who had CDF and depressive symptoms at age 16 were reclassified as not having CDF. RESULTS: In fully adjusted models using imputed data (N = 13,978), depressive symptoms at ages 9, 11, and 13 years were associated with 2- to 3-fold higher odds of CDF at age 16. Each one-point increase in SMFQ score at ages 9, 10, 11, 12, and 13 years was associated with 6-11% higher odds of CDF at age 16. Depressive symptoms and continuous SMFQ scores at each age were not associated with CDF if the outcome was reclassified to exclude children with comorbid depressive symptoms at age 16. CONCLUSIONS: Depressive symptoms at ages 9-13 were associated with chronic disabling fatigue at age 16, but causality is not certain.

Defining the minimally clinically important difference of the SF-36 physical function subscale for paediatric CFS/ME: triangulation using three different methods.

BACKGROUND: Defining the minimally clinically important difference (MCID) is important for the design and analysis of clinical trials and ensures that findings are clinically meaningful. Studies in adult populations have investigated the MCID of The Short Form 36 physical function sub-scale (SF-36-PFS). However, to our knowledge no studies have defined the MCID of the SF-36-PFS in a paediatric population. We aimed to triangulate findings from distribution, anchor and qualitative methods to identify the MCID of the SF-36-PFS for children and adolescents with CFS/ME. METHODS: Quantitative methods: We analysed routinely-collected data from a specialist paediatric CFS/ME service in South-West England using: 1) the anchor method, based on Clinical Global Impression (CGI) outcomes at 6 months' follow-up; 2) the distribution method, based on the standard deviation of baseline SF-36-PFS scores. Qualitative methods: Young people (aged 12-17 years) and parents were asked to complete the SF-36-PFS, marking each question twice: once for where they would currently rate themselves/their child and a second time to show what they felt would be the smallest amount of change for them/their child to feel treatment had made a difference. Semi-structured interviews were designed to explore what factors were deemed important to patients and to what extent an improvement was considered satisfactory. We thematically analysed qualitative interviews from 21 children and their parents. RESULTS: Quantitative results: Six-month follow-up data were available for 198 children with a mean age of 14 years. Most were female (74%, 146/198) and 95% gave their ethnicity as "White British". Half the standard deviation of the baseline SF-36-PFS scores was 11.0. "A little better" on the CGI equated to a mean difference on the SF-36-PFS from baseline to 6-month follow-up of 9.0. Qualitative results: Twenty-one children with CFS/ME participated: 16 females (76.2%) with a mean age of 14.4 years. Twenty mothers and two fathers were also interviewed. The median minimal improvement in the SF-36-PFS was 10. Participants indicated that small changes in physical function can lead to important improvements in valued social and family function. Patients and parents were positive about improvement even in the presence of persisting symptoms. Triangulation: The MCID based on the mean score from the three methods was 10. CONCLUSIONS: Converging evidence indicates future studies in paediatric CFS/ME should use an MCID of 10 on the SF-36-PFS.