Parent-reported Outcome Measures Research Articles

A pilot practice-based outcomes evaluation of low-intensity cognitive behavioural interventions delivered by postgraduate trainees to children and young people with mild to moderate anxiety or low mood: an efficient way forward in mental health care?

AbstractAnxiety and depression affect a significant number of children and young people (CYP) and can have a far reaching and long-lasting impact. Cognitive behavioural (CB) interventions can be effective for treating anxiety and depression in CYP but are difficult to access. Recent government policy in England seeks to train a non-traditional graduate workforce to deliver a range of CB interventions for mild to moderate anxiety and depression to CYP, in community settings. This practice-based evaluation aimed to estimate the effectiveness of CB interventions delivered by postgraduate trainees undertaking training in a range of CB interventions for mild to moderate anxiety and depression whilst on placement in schools or community Child and Adolescent Mental Health Services (CAMHS). Self- and parent-reported routine outcome measures (ROMS) were completed pre- and post-intervention, including measures of symptom severity, symptom impact and goal achievement. Significant improvements were demonstrated across all self and parent-reported measures post-intervention, with mean scores falling firmly in the non-clinical range, a significant reduction in the proportion of CYP in the clinical range on measures, and predominantly medium to large effect sizes. Results are promising in terms of the capacity to train a graduate workforce to deliver a range of low-intensity CB interventions to CYP experiencing mild to moderate depression or anxiety-based difficulties in either CAMHS or school settings, increasing capacity across the system. The current practice-based evaluation also supports the potential effectiveness of current training models/programmes. Further research is needed in terms of long-term outcomes and to compare outcomes between settings, interventions, and demographic groups.Key learning aims(1)To understand the potential prevalence rates of mental health difficulties in children and young people in England, and their wider impact.(2)Critical awareness of the evidence base for cognitive and behavioural interventions for depression and anxiety in children and young people.(3)Awareness of gaps in access to evidence-based psychological interventions for children and young people in England.(4)Knowledge of emerging graduate-level low-intensity psychological practitioner roles in England.(5)Awareness of the emerging evidence base for the estimated effectiveness of low-intensity cognitive and behavioural interventions delivered to children and young people by graduate-level practitioners in schools and community mental health settings.

Rasch Analysis of Patient- and Parent-Reported Outcome Measures in the International Consortium for Health Outcomes Measurement Standard Set for Cleft Lip and Palate

ObjectivesThe aim of this study was to evaluate the psychometric performance of the patient- and parent-reported measures in the International Consortium for Health Outcomes Measurement (ICHOM) Standard Set for Cleft Care, and to identify ways of improving concept coverage. MethodsData from 714 patients with cleft lip and/or palate, aged 8 to 9, 10 to 12.5, and 22 years were collected between November 2015 and April 2019 at Erasmus University Medical Center, Boston Children’s Hospital, Duke Children’s Hospital, and from participating sites in the CLEFT-Q Phase 3 study. The Standard Set includes 9 CLEFT-Q scales, the Nasal Obstruction Symptom Evaluation (NOSE) questionnaire, the Child Oral Health Impact Profile–Oral Symptoms Scale (COHIP-OSS), and the Intelligibility in Context Scale (ICS). Targeting, item-fit statistics, thresholds for item responses, and measurement precision (PSI) were analyzed using Rasch measurement theory. ResultsThe proportion of the sample to score within each instruments range of measurement varied from 69% (ICS) to 92% (CLEFT-Q teeth and COHIP-OSS). Specific problems with individual items within the NOSE and COHIP-OSS questionnaires were noted, such as poor item fit to the Rasch model and disordered thresholds (6 of 10). Reliability measured with PSI was above 0.82 for the ICS and all but one CLEFT-Q scale (speech distress). PSIs were lowest for the COHIP-OSS (0.43) and NOSE questionnaire (0.35). ConclusionThe patient- and parent-reported components within the facial appearance, psychosocial function, and speech domains are valid measures; however, the facial function and oral health domains are not sufficiently covered by the CLEFT-Q eating and drinking, NOSE, and COHIP-OSS, and these questionnaires may not be accurate enough to stratify cleft-related outcomes.

Neuropathic pain in children: Steps towards improved recognition and management.

Neuropathic pain in children can be severe and persistent, difficult to recognise and manage, and associated with significant pain-related disability. Recognition based on clinical history and sensory descriptors is challenging in young children, and screening tools require further validation at older ages. Confirmatory tests can identify the disease or lesion of the somatosensory nervous system resulting in neuropathic pain, but feasibility and interpretation may be influenced by age- and sex-dependent changes throughout development. Quantitative sensory testing identifies specific mechanism-related sensory profiles; brain imaging is a potential biomarker of alterations in central processing and modulation of both sensory and affective components of pain; and genetic analysis can reveal known and new causes of neuropathic pain. Alongside existing patient- and parent-reported outcome measures, somatosensory system research methodologies and validation of mechanism-based standardised end-points may inform individualised therapy and stratification for clinical trials that will improve evidence-based management of neuropathic pain in children.

A systematic review of parent based programs to prevent or reduce alcohol consumption in adolescents

BackgroundAdolescent alcohol consumption is an issue of ongoing concern and programs targeting parents have been identified as an important component in minimizing and preventing alcohol related harm in adolescents. This paper aims to evaluate existing parent based alcohol education programs with a focus on understanding parent specific outcomes including parental attitudes, parent-child communication, alcohol specific rule setting and parental monitoring; study quality, the extent of stakeholder engagement in program design and the level of theory application.MethodA systematic review of electronic databases EBSCO, Emerald, ProQuest, PubMed, Ovid, ScienceDirect, Taylor and Francis and Web of Science was conducted from database inception to August 2019. A total of 4288 unique records were retrieved from the eight databases. Studies were included if they evaluated school based alcohol education programs that included a parent component and detailed outcome measures associated with parent data. The methodological quality of the included studies was assessed using the Effective Public Health Practice Project (EPHPP) quality assessment tool.ResultsIn total 17 studies qualified for assessment, detailing 13 individual parent programs. Of these, ten programs demonstrated positive effects in at least one parent reported outcome measure. Stakeholder engagement during the design of programs was lacking with the majority of programs. One third of the programs did not report theory use and when theory was used reporting was weak with three programs applying theory, five testing theory and none building theory. According to the EPHPP tool, overall ten programs were rated as weak, three as moderate and none as strong.ConclusionFuture studies are recommended to further enhance the effectiveness of parental programs by improving study quality, increasing stakeholder engagement and increasing the level of theory application and reporting.

Usefulness of a Novel System for Feedback of Patient-Reported Outcome Measures in Children Recovering From Burns.

The Burn Outcomes Questionnaire for children ages 5-18 years (BOQ5-18) is a widely used, reliable, and valid parent-reported outcome measure designed to assess children's recovery from burn injuries in 12 physical and psychosocial domains. This study evaluated the feasibility, acceptability, and usefulness of a feedback system that delivered BOQ and Pediatric Symptom Checklist (PSC-17; a widely used measure of psychosocial functioning) results to burn care clinicians prior to an outpatient appointment or a postoperative surgical encounter. The BOQ and the PSC-17 were administered to the parents of 147 children receiving outpatient or surgical care in two pediatric burn hospitals. Clinician and parent perceptions of the feedback system were evaluated using debriefing questionnaires. Over half of all patients were at-risk on at least one BOQ subscale, and risk on three or more BOQ domains was significantly associated with a higher likelihood of poor psychological scores on the PSC-17 (P < .001). Significant differences in BOQ scores were found between the two hospital sites on four BOQ subscales, three related to physical ability and one to psychosocial well-being. Parent ratings of the feedback system were positive, with 90% of parents in both settings agreeing that the BOQ tablet experience was easy and helpful. Clinician attitudes differed across the two settings with more positive clinician ratings of the system in the outpatient setting (P < .001). Clinician interviews revealed that the data was especially useful in bringing to light psychosocial aspects of functioning relevant to long-term recovery from burn injuries.

Psychometric properties of the quality of life in short statured youth (QoLISSY) questionnaire within the course of growth hormone treatment

BackgroundThe Quality of Life of Short Stature Youth (QoLISSY) questionnaire is a patient- and parent-reported outcome measure assessing health-related quality of life (HRQOL) in short stature youth. This study evaluates the psychometric properties of the QoLISSY questionnaire within a German prospective trial of short statured children treated with human growth hormone (hGH).MethodThe instrument was administered to children with idiopathic growth hormone Deficiency (IGHD) and small for gestational age (SGA) before and after 12 month of hGH treatment. Children with idiopathic short stature (ISS) served as a reference group receiving no treatment. Psychometric testing included scale distribution characteristics, reliability (internal consistency), criterion-and convergent validity (correlations with the generic KIDSCREEN-Index, inter-correlations among QOLISSY subscales), known-group validity (treatment status, height SDS), and responsiveness analysis (ability to detect change).ResultsOne hundred fifty-two parents and 66 children/adolescents completed both HRQOL assessments. The QoLISSY demonstrated good reliability with Cronbach’s alpha > .70. Moderate significant correlations between QoLISSY domains and the KIDSCREEN-10 Index supported criterion validity. Statistically significant differences in HRQOL were observed between treatment groups at baseline with children who were about to start treatment reporting a significantly lower HRQOL compared to the children who will not receive treatment. No significant differences were found between the level of short stature based on height SDS scores (≤ − 2 SDS, > − 2 SDS). Furthermore, the instrument detected significant changes in HRQOL between the treated and the untreated group in patient-reports.ConclusionsIn conclusion, the scales showed satisfactory reliability, adequate validity and ability to detect change in self-reported HRQOL within GH treatment. Findings support QoLISSY’s further use in clinical trials, offering the opportunity to adequately assess HRQOL from the patients’ and caregivers’ perspective to improve patient-centered care.

Evaluation of a simple tool to assess the results of Ponseti treatment for use by clubfoot therapists: a diagnostic accuracy study

BackgroundWe aimed to develop and evaluate a tool for clubfoot therapists in low resource settings to assess the results of Ponseti treatment of congenital talipes equinovarus, or clubfoot, in children of walking age.MethodA literature review and a Delphi process based on the opinions of 35 Ponseti trainers in Africa were used to develop the Assessing Clubfoot Treatment (ACT) tool and score. We followed up children with clubfoot from a cohort treated between 2011 and 2013, in 2017. A full clinical assessment was conducted to decide if treatment was successful or if further treatment was required. The ACT score was then calculated for each child. Inter-observer variation for the ACT tool was assessed. Sensitivity, specificity, positive and negative predictive values were calculated for the ACT score compared to full clinical assessment (gold standard). Predictors of a successful outcome were explored.ResultsThe follow up rate was 31.2% (68 children). The ACT tool consisted of 4 questions; each scored from 0 to 3, giving a total from 0 to 12 where 12 is the ideal result. The 4 questions included one physical assessment and three parent reported outcome measures. It took 5 min to administer and had excellent inter-observer agreement.An ACT score of 8 or less demonstrated 79% sensitivity and 100% specificity in identifying children that required further intervention, with a positive predictive value of 100% and negative predictive value of 90%. Children who completed two or more years of bracing were four times more likely to achieve an ACT score of 9 or more compared to those who did not (OR: 4.08, 95% CI: 1.31–12.65, p = 0.02).ConclusionsThe ACT tool is simple to administer, had excellent observer agreement, and good sensitivity and specificity in identifying children who need further intervention. The score can be used to identify those children who definitely need referral and further treatment (score 8 or less) and those with a definite successful outcome (score 11 or more), however further discrimination is needed to decide how to manage children with a borderline ACT score of 9 or 10.Level of evidenceLevel II, Diagnostic Study.

Responsiveness of a parent-reported outcome measure to evaluate AAC interventions for children and youth with complex communication needs

Evaluation of the effectiveness of augmentative and alternative communication (AAC) interventions requires reliable measures that are responsive to change. The aim of this study was to explore the potential of the Family Impact of Assistive Technology Scale for AAC (FIATS-AAC) to detect functional change in children and youth with AAC needs, aged 3–17 years, and their families, 6 and 12 weeks after receiving a graphic-based, speech-generating device (SGD). Parents whose children were awaiting a SGD as part of their regular AAC service participated in the study. In all, 45 parents completed the FIATS-AAC during each of three phone interviews: at the time of device delivery, and then 6 weeks and 12 weeks after receiving the device. Children and youth were aged 3–16 years (M = 7.8, SD = 3.3) and were mostly context-dependent communicators. Paired t-tests indicated statistically significant gains in functioning from baseline to both 6 and 12 weeks after receiving the AAC device. Effect sizes were 0.41 and 0.38, respectively. This study provides initial support for the ability of the FIATS-AAC to detect functional changes in children and youth and their families after receiving a graphic-based SGD.

Health-related quality of life, temperament, and eating behavior among formula-fed infants in the Philippines: a pilot study

BackgroundThe rising prevalence of childhood obesity in Asia has led to interest in potential risk factors such as infant health-related quality of life (HRQoL), temperament and eating behaviors. This pilot study evaluated the utility of administering parent-reported outcome measures (PROMs) to explore these factors in Filipino infants and examined the relationships between these factors and infant sex, formula intake and weight, over time.MethodsForty healthy, 4-week-old, formula-fed infants (n = 20 males) were enrolled in this 6-week, prospective, uncontrolled study during which infants were exclusively fed a standard term infant formula enriched with alpha-lactalbumin. On Day-1 and 42, anthropometrics were measured and mothers completed a 97-item measure of HRQoL [Infant Toddler Quality of Life Questionnaire (ITQOL)] covering 6 infant-focused and 3 parent-focused concepts and a 24-item measure of infant temperament [Infant Characteristics Questionnaire (ICQ)]. At Day-42, mothers also completed an 18-item measure of infant appetite [Baby Eating Behaviour Questionnaire (BEBQ)]. A 3-day formula intake diary was completed before Day-42. Nonparametric statistics were used to evaluate correlations among outcomes and compare outcomes by visit and sex.ResultsThirty-nine infants completed the study; similar results were observed in males and females. Completion of PROMs was 100% with no missing responses, but Cronbach’s α was low for many concept scales scores. ITQOL scores [range 0 (worst)-100 (best)] were generally high (median ≥ 80) except for Day-1 and Day-42 Temperament and Mood and Day-1 General Health Perceptions scores. ITQOL but not ICQ temperament scores improved significantly between Day-1 and Day-42 (P < 0.01). Mean ± standard deviation BEBQ scores (range 1–5) were high for Enjoyment of Food (4.59 ± 0.60) and Food Responsiveness (3.53 ± 0.81), and low for Satiety Responsiveness (2.50 ± 0.73) and Slowness in Eating (1.71 ± 0.60). Better HRQoL scores were significantly (P < 0.05) associated with high General Appetite scores (3 ITQOL concepts, r = 0.32 to 0.54), greater Enjoyment of Food (4 ITQOL concepts, r = 0.35 to 0.42) and low levels of Slowness in Eating (7 ITQOL concepts, r = − 0.32 to − 0.47).ConclusionFindings demonstrated the utility of the ITQOL, ICQ and BEBQ for measuring HRQoL, temperament and eating behavior, and the need for further adaptations for use in Filipino infants.Trial registrationClinicalTrials.gov identifier NCT02431377; Registered May 1, 2015.

Impact of family integrated care on infants\u2019 clinical outcomes in two children\u2019s hospitals in China: a pre-post intervention study

BackgroundMost Neonatal Intensive Care Units (NICUs) in China have restricted visiting policies for parents. This also implicates that parents are not involved in the care of their infant. Family Integrated Care (FIC), empowering parents in direct care delivery and decisions, is becoming the standard in NICUs in many countries and can improve quality-of-life and health outcomes of preterm infants. The aim of this study was to evaluate the impact of a FIC intervention on the clinical outcomes of preterm infants with Bronchopulmonary Dysplasia (BPD).MethodsA pre-post intervention study was conducted at NICUs in two Chinese children’s hospitals. Infants with BPD were included: pre-intervention group (n = 134) from December 2015 to September 2016, post-intervention (FIC) group (n = 115) and their parents from October 2016 to June 2017. NICU nurses were trained between July and September 2016 to deliver the FIC intervention, including parent education and support. Parents had to be present and care for their infant minimal three hours a day. The infants’ outcome measures were length-of-stay, breastfeeding, weight gain, respiratory and oxygen support, and parent hospital expenses.ResultsCompared with control group (n = 134), the FIC group (n = 115) had significantly increased breastfeeding rates (83% versus 71%, p = 0.030), breastfeeding time (31 days versus 19 days, p < 0.001), enteral nutrition time (50 days versus 34 days, p < 0.001), weight gain (29 g/day versus 23 g/day, p = 0.002), and significantly lower respiratory support time (16 days versus 25 days, p < 0.001). Oxygen Exposure Time decreased but not significant (39 days versus 41 days p = 0.393). Parents hospital expenses in local Chinese RMB currency was not significant (84 K versus 88 K, p = 0.391).ConclusionThe results of our study suggests that FIC is feasible in two Chinese NICUs and might improve clinical outcomes of preterm infants with BPD. Further research is needed to include all infants admitted to NICUs and should include parent reported outcome measures. Our study may help other NICUs with limited parental access to implement FIC to enhance parental empowerment and involvement in the care of their infant.

Patient and parent reported outcome measures in cleft lip and palate patients before and after secondary alveolar bone grafting.

European and Northern American healthcare authorities increasingly encourage the use of Patient Reported Outcome Measures (PROMs) that complement clinical and laboratory assessments to help holistically evaluate reconstructive outcomes. This is the first study to evaluate PROMs in cleft lip/palate patients who have, or have not, undergone secondary alveolar bone grafting (SABG).A PROMs study was conducted; 40 consecutive consenting cleft lip/palate children between 8 and 14 years old were included. Twenty patients did, and 20 patients did not, have SABG. PROMs scores from children and parents in the 2 groups were compared.Forty patients completed the trial. No significant differences in total score from the Chang Gung Short Form-15 (CGSF-15) were found between children and their parents. Children with SABG reported no more oral-nasal regurgitation than children without SABG, but tended to report more nasal obstruction. There were no statistically significant differences in parent reported outcomes between the 2 groups.Cleft lip/palate patients who underwent SABG reported significantly less nasal regurgitation and more nasal obstruction compared to those patients who did not undergo SABG.

Brief Behavioural Activation (Brief BA) for Adolescent Depression: A Pilot Study.

Depression in adolescence is a common and serious mental health problem. In the UK, access to evidence-based psychological treatments is limited, and training and employing therapists to deliver these is expensive. Brief behavioural activation for the treatment of depression (BATD) has great potential for use with adolescents and to be delivered by a range of healthcare professionals, but there is limited empirical investigation with this group. To adapt BATD for depressed adolescents (Brief BA) and conduct a pilot study to assess feasibility, acceptability and clinical effectiveness. Twenty depressed adolescents referred to the local NHS Child and Adolescent Mental Health service (CAMHs) were offered eight sessions of Brief BA followed by a review around one month later. Self- and parent-reported routine outcome measures (ROMs) were collected at every session. Nineteen of the 20 young people fully engaged with the treatment and all reported finding some aspect of Brief BA helpful. Thirteen (65%) required no further psychological intervention following Brief BA, and both young people and parents reported high levels of acceptability and satisfaction with the approach. The pre-post effect size of Brief BA treatment was large. Brief BA is a promising innovation in the treatment of adolescent depression. This approach requires further evaluation to establish effectiveness and cost effectiveness compared with existing evidence-based treatments for adolescent depression. Other questions concern the effectiveness of delivery in other settings and when delivered by a range of professionals.

Ponseti method compared to previous treatment of clubfoot in Norway. A multicenter study of 205 children followed for 8-11years.

PurposeDespite few studies comparing Ponseti treatment and traditional treatment of clubfoot (talipes equinovarus), the Ponseti method is now accepted as standard treatment for this deformity. The Ponseti method was introduced in Norway in 2003 and the purpose of this multicenter-study was to compare the results of Ponseti treatment with the results of the previous treatment for clubfoot in Norway.Methods90 children (134 clubfeet) treated with previous treatment (pre-Ponseti group), were compared to 115 Ponseti treated children (160 clubfeet) (Ponseti group). The previous treatment consisted of casting and surgery if needed. At 8–11 years of age, all children were examined by the same orthopaedic surgeon, the parents answered a questionnaire, all feet were X-rayed and information about surgical procedures was obtained from the patient records.ResultsThe number of surgeries was higher in the pre-Ponseti group, and the number of extensive surgeries was 119 in the pre-Ponseti group compared to 19 in the Ponseti group. The range of motion in the ankle joint was better in the Ponseti group. Children in this group had better function, higher satisfaction and less pain according to patient and parent reported outcome measures. The incidence of moderate or severe talar flattening was higher in the pre-Ponseti group.ConclusionPonseti treatment seems to be superior to the previous treatment in Norway, with regards to number and severity of operations, flexibility of the foot and ankle, parent/patient reported outcome and the presence of talar flattening on X-ray.

A comparison of parent reported outcome with experience of services

Purpose – Routine outcome monitoring (ROM) is currently seen as a key driver for service improvement at individual, team and service level. The purpose this paper is to explore the relationships between a patient (parent) reported outcome measure (PROM), a practitioner reported outcome measure, and a patient (parent) reported experience measure (PREM). Design/methodology/approach – A cohort of 302 primary school-age children was recruited and followed for one year from consecutively accepted referrals to three teams within two English Child and Adolescent Mental Health Services (CAMHS). Parents completed the Strengths and Difficulties Questionnaire (a PROM) and practitioners completed the Clinician Global Assessment Scale at baseline, six and 12 months; parents completed the Experience of Services Questionnaire (a PREM) at six and 12 months. Findings – PROM and practitioner reported outcome measure data suggested poor clinical outcome in terms of symptoms, impact and levels of functioning but were accompanied by PREM evidence of high levels of satisfaction. There was an unexpectedly low correlation ( &lt; 0.2) between both measures of outcome and satisfaction. Originality/value – This paper fulfils a need to explore the relationships between different outcome measures to contribute to the understanding of ROM its validity.

Do Patient- and Parent-reported Outcomes Measures for Children With Congenital Hand Differences Capture WHO-ICF Domains?

Patient- and parent-reported outcome measures (PROMs) are increasingly used to evaluate the effectiveness of surgery for congenital hand differences (CHDs). Knowledge of an existing outcome measure's ability to assess self-reported health, including psychosocial aspects, can inform the future development and application of PROMs for CHD. However, the extent to which measures used among children with CHD align with common, accepted metrics of self-reported disability remains unexplored. We reviewed studies that used PROMs to evaluate surgery for CHD to determine (1) the number of World Health Organization-International Classification of Functioning, Disability and Health (WHO-ICF) domains covered by existing PROMs; (2) the proportion of studies that used PROMs specifically validated among children with CHD; and (3) the proportion of PROMs that targets patients and/or parents. We performed a comprehensive review of the literature through a bibliographic search of MEDLINE®, PubMed, and EMBASE from January 1966 to December 2014 to identify articles related to patient outcomes and surgery for CHD. We evaluated the 42 studies that used PROMs to identify the number and type of WHO-ICF domains captured by existing PROMs for CHD and the proportion of studies that use PROMs validated for use among children with CHD. The most common instruments used to measure patient- and parent-reported outcomes after reconstruction for CHD included the Prosthetic Upper Extremity Functional Index (PUFI), Disabilities of the Arm, Shoulder, and Hand questionnaire, Childhood Experience Questionnaire, and Pediatric Quality of Life Inventory. Current PROMs that have been used for CHD covered a mean of 1.3 WHO-ICF domains (SD ± 1.3). Only the Child Behavior Checklist and the Piers-Harris Children's Self-Concept Scale captured all ICF domains (body functions and structures, activity, participation, and environmental factors). The PUFI, the only PROM validated specifically for children with congenital longitudinal and transverse deficiency, was used in only four of 42 studies. Only 13 of the 42 studies assessed patient-reported outcomes, whereas five assessed both patient- and parent-reported outcomes. The PROMs used to assess patients after CHD surgery do not evaluate all WHO-ICF domains (ie, body structure, body function, environmental factors, and activity and participation) and generally are not validated for children with CHD. Given the psychological and sociological aspects of CHD illness, a PROM that encompasses all components of the biopsychosocial model of illness and validated in children with CHD is desirable. Level III, therapeutic study.

Measure of Participation and the Sensory Environment for Young Children With Autism

Abstract Date Presented 4/18/2015 In this presentation, we provide an overview of a qualitative study completed to establish content validity for the development of a parent-reported outcome measure that assesses the environmental impact on participation in daily activity for young children with autism spectrum disorders.

The effectiveness of psychosocial interventions for anxiety in children and adolescents with autism spectrum disorder: a systematic review and meta-analysis.

Anxiety is a common problem in children and adolescents with autism spectrum disorder (ASD). This meta-analysis aimed to systematically evaluate the evidence for the use of psychosocial interventions to manage anxiety in this population. Cognitive behavioural therapy (CBT) was the primary intervention modality studied. A comprehensive systematic search and study selection process was conducted. Separate statistical analyses were carried out for clinician-, parent-, and self-reported outcome measures. Sensitivity analyses were conducted by removing any outlying studies and any studies that did not use a CBT intervention. A subgroup analysis was performed to compare individual and group delivery of treatment. Ten randomised control trials involving a total of 470 participants were included. The overall SMD was d = 1.05 (95 % CI 0.45, 1.65; z = 3.45, p = 0.0006) for clinician- reported outcome measures; d = 1.00 (95%CI 0.21, 1.80; z = 2.47, p = 0.01) for parent-reported outcome measures; and d = 0.65 (95%CI -0.10, 1.07; z = 1.63, p = 0.10) for self-reported outcome measures. Clinician- and parent-reported outcome measures showed that psychosocial interventions were superior to waitlist and treatment-as-usual control conditions at post-treatment. However, the results of self-reported outcome measures failed to reach significance. The sensitivity analyses did not significantly change these results and the subgroup analysis indicated that individual treatment was more effective than group treatment. The main limitations of this review were the small number of included studies as well as the clinical and methodological variability between studies.

Does Administering a Parent Reported Outcome Measure during the Annual Review Process Improve the Self-Efficacy of Carers of Children with Cystic Fibrosis

Background and Aims: Cystic fibrosis (CF) is the most common life limiting, inherited disease to affect the Caucasian population. Medical advances have resulted in a longer life expectancy, at the expense of an intensive and often time-consuming treatment regime for patients. Children with CF rely on their primary care givers for adequate treatment. The ‘Challenges of Living with Cystic Fibrosis Questionnaire’ (CLCF-Q) has been developed as a tool to measure the burden of caring for a child with CF. The aim of this study is to identify whether the self-efficacy, as measured by the ‘Cystic Fibrosis Self-Efficacy Questionnaire’ (CFSE-Q), can be improved by administering the CLCF-Q to the carer during the child's annual review. Methods: This is a single centre, randomised control trial. Participants randomised to Group1 (intervention group) receive the CLCF-Q during the annual review. Group 2 is the control group. Those in Group 1 receive feedback based on their answers from the CLCF-Q. All participants complete the CFSE-Q at the beginning and end of the study (Phase I and Phase II respectively). Results: Interim analysis demonstrates that participants in Group 1 (n=11) have a significantly greater improvement in their self-efficacy scores than Group 2 participants (n=15), at the end of phase II of the trial (Median (IQR) change in self-efficacy score 1 (-1 to 4) versus -2 (-4 to 1); U=41.000, p=0.031). Conclusions: This study suggests that self-efficacy in carers of children with CF can be improved by administering and giving feedback on the CLCF-Q.

The 14-item Paediatric Throat Disorders Outcome Test: a valid, sensitive, reliable, parent-reported outcome measure for paediatric throat disorders

We modified and abbreviated a pre-existing research questionnaire, the Tonsil and Adenoid Health Status Instrument, to make it suitable for rapid completion as a disease-specific, health-related quality of life research tool for children with tonsil and adenoid disease in the UK. We determined the main psychometric properties of the resulting 14-item Paediatric Throat Disorders Outcome Test. Pre- and post-operative questionnaires were completed by the parents of children with throat disorders referred to two large hospitals. We included children with recurrent tonsillitis and with obstructive sleep apnoea. A separate cohort of healthy children of comparable age range was also studied. The test's internal consistency and responsiveness were analysed and its construct validity documented via known-group differences. A total of 126 completed questionnaires were received from the hospital referral group. The children's mean age was 6.5 years (range one to 16). The 40 unaffected children were well matched in age to the study population (mean 6.1 years, range two to 15). Cronbach's alpha coefficient for the pre-operative assessment total score was 0.84. The test-retest reliability coefficient for the total score was 0.98, indicating very high reproducibility. The 14-item Paediatric Throat Disorders Outcome Test discriminated well between children known to suffer with throat problems and a group of healthy controls (p < 0.0001; t = 24.016). Six months after surgical intervention, parentally reported questionnaire scores had improved (i.e. were lower) (p < 0.0001; t = 7.01). The standard effect size (i.e. change in mean divided by baseline standard deviation) for children for whom post-operative questionnaires were completed was 1.53; this is very large. The 14-item Paediatric Throat Disorders Outcome Test is an appropriate, disease-specific, parent-reported outcome measure for children with throat disorders, for which we have demonstrated internal consistency, reliability, responsiveness to change and two forms of construct validity.