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1.  Effect of behavioral intervention using smartphone application for preoperative anxiety in pediatric patients 
Korean Journal of Anesthesiology  2013;65(6):508-518.
Children and parents experience significant anxiety and distress during the preoperative period. This is important because preoperative anxiety in children is associated with adverse postoperative outcome. So we suggest behaviorally oriented preoperative anxiety intervention program based on the anesthesia and psychology with smartphone application, world-widely used.
A total 120 patients (aged 1-10 years old) who were scheduled for elective surgery under general anesthesia was included in this randomized controlled trial. We randomized the patients into three groups, with using intravenous (IV) midazolam sedation (M group), with using smartphone application program (S group), and with using low dose IV midazolam plus smartphone application program (SM group). And the child anxiety was assessed using the modified Yale Preoperative Anxiety Scale (mYPAS) at holding area, 5 min after intervention, entrance to operating room.
In all three groups, mYPAS after intervention were lower than the preoperative holding area (M group 52.8 ± 11.8 vs 41.0 ± 7.0, S group 59.2 ± 17.6 vs 36.4 ± 7.3, SM group 58.3 ± 17.5 vs 26.0 ± 3.4). A comparison of mYPAS scores between each group showed that the S group reduced anxiety lower than M group (P < 0.01), and the SM group exhibited significantly lower anxiety than the two other groups (P < 0.01).
The preoperative preparation program using smartphone application is simple and customized by individual development that effective in the reduction of preoperative anxiety.
PMCID: PMC3888843  PMID: 24427456
Anxiety; Child; Preoperative care
2.  Anxiety and stress in mothers and fathers in the 24 h after their child’s surgery 
Background and objective
Surgery in a paediatric setting stresses children and their parents. Previous studies have focused on children and the preoperative period; however, the 24 h after child surgery are highly stressful for parents as their child is still physically recovering and physician–parent communication is vital. The aims of this study are to investigate the impact of three levels of severity of paediatric surgery on mothers’ and fathers’ anxiety and stress and to identify factors that contribute to parental anxiety and acute stress symptoms in the first 24 h after child surgery.
Patients and methods
A total of 154 parents (91 mothers, 63 fathers) of children who had just undergone elective surgery for a major intervention (n = 41), minor intervention (n = 64) or day surgery (n = 49) completed questionnaires aimed at assessing levels of state anxiety and acute stress symptoms. Social network, socio-economic status and parental health locus of control were evaluated as contributors.
Parents reported high levels of state anxiety (26% had scores on the state scale 2 standard deviations above the norm) and acute stress symptoms (28% in at least one of the four acute stress disorder symptom categories). Child’s type of surgery is related to parental anxiety [F(2,134) = 38.12, P = 0.0001, η2 = 0.175] and acute stress symptoms [F(2,133) = 31.21, P = 0.0001, η2 = 0.133]. Parental state anxiety was predicted by parent’s gender, trait anxiety and health external locus of control. Parent’s number of acute stress symptoms was predicted by parental trait anxiety, health external locus of control, parent’s level of education and the number of social contacts.
There is a need to take into consideration parental anxiety and distress in the 24 h after child surgery. Parental well-being is related to several characteristics including the severity of child surgery; these aspects should be taken into consideration when interacting with parents in the aftermath of their child’s surgery.
PMCID: PMC3496245  PMID: 19228156
paediatric surgery; parental anxiety and acute stress symptoms; parent–physician communication
3.  General anaesthesia or conscious sedation for painful procedures in childhood cancer: the family‘s perspective 
Archives of Disease in Childhood  2003;88(3):253-257.
Background: Until recently, midazolam sedation was routinely used in our institution for bone marrow aspirates and lumbar punctures in children with cancer. It has been perceived by many doctors and nurses as being well tolerated by children and their families.
Aim: To compare the efficacy of inhalational general anaesthesia and midazolam sedation for these procedures.
Methods: A total of 96 children with neoplastic disorders, who received either inhalational general anaesthesia with sevoflurane, nitrous oxide, and oxygen (GA) or sedation with oral or nasal midazolam (SED) as part of their routine preparation for procedures were studied. The experiences of these childen were examined during their current procedure and during their first ever procedure. Main outcome measures were the degree of physical restraint used on the child, and the levels of distress and pain experienced by the child during the current procedure and during the first procedure. The family‘s preference for future procedures was also determined.
Results: During 102 procedures under GA, restraint was needed on four occasions (4%) when the anaesthetic mask was first applied, minimal pain was reported, and children were reported as distressed about 25% of the time. During 80 SED procedures, restraint was required in 94%, firm restraint was required in 66%, the child could not be restrained in 14%, median pain score was 6 (scale 0 (no pain) to 6 (maximum pain)), and 90% of the parents reported distress in their child. Ninety per cent of families wanted GA for future procedures. Many families reported dissatisfaction with the sedation regime and raised concerns about the restraint used on their child.
Conclusions: This general anaesthetic regime minimised the need for restraint and was associated with low levels of pain and distress. The sedation regime, by contrast, was much less effective. There was a significant disparity between the perceptions of health professionals and those of families with respect to how children coped with painful procedures.
PMCID: PMC1719477  PMID: 12598395
4.  Improving access to preparatory information for children undergoing general anaesthesia for tooth extraction and their families: study protocol for a Phase III randomized controlled trial 
Trials  2014;15:219.
Children can find anaesthesia induction especially distressing and postoperative psychological and physical morbidity are common. Preparation programmes for general anaesthesia (GA) are highly effective in reducing this distress. A Phase II study has already verified the effectiveness of a prototype preoperative GA-coping computer game to help children cope with induction in a dental GA setting. The biggest patient users of pediatric GA services in the UK are children who need to have teeth removed (estimated to be 100,000 yearly). Tooth decay is the most common disease in children worldwide. This study is a Phase III randomized controlled trial (RCT) and will evaluate the effectiveness of the new internet version of this game.
The Phase III RCT will use a double-blind three-armed design. The clinical trial will recruit up to 210 children and will compare the web-based game against standard care and another non-medical game. At least 53 patients in each group will be required for 90% statistical power. Distress will be assessed through an evaluation of the child’s behaviour during the visit and later parental reports of physical and psychological morbidity. The satisfaction of parents and children will be measured; the mode of usage of the web-based game will be automatically recorded and the impact on the service (for example, recovery time and throughput) will be reported.
The Phase III study primary outcome will measure: (1) patient experience: acceptance of anaesthetic induction, child cooperation and distress, reduction of peri- and postoperative morbidity, child and family satisfaction, and (2) service improvement: anaesthetic time and improvement in throughput. Measures will be administered at baseline, at the time of the GA treatment visit, and at 48 hours and one week postoperatively.
This study aims to determine the effectiveness of an online GA-coping game for children and families undergoing tooth extraction under GA.
Trial registration
ISRCTN18265148 (registered 24 November 2013).
PMCID: PMC4229849  PMID: 24919430
General anaesthesia; Children; Preparatory information; Coping; Cognitive behavioural therapy; Role modelling; Early childhood caries; Dental anxiety; Randomized controlled trial (RCT)
5.  Changing Healthcare Providers’ Behavior during Pediatric Inductions with an Empirically-based Intervention 
Anesthesiology  2011;115(1):18-27.
Each year over 4 million children experience significant levels of preoperative anxiety, which has been linked to poor recovery outcomes. Healthcare providers (HCP) and parents represent key resources for children to help them manage their preoperative anxiety. The present study reports on the development and preliminary feasibility testing of a new intervention designed to change HCP and parent perioperative behaviors that have been previously reported to be associated with children’s coping and stress behaviors before surgery.
An empirically-derived intervention, Provider-Tailored Intervention for Perioperative Stress, was developed to train HCPs to increase behaviors that promote children’s coping and decrease behaviors that may exacerbate children’s distress. Rates of HCP behaviors were coded and compared between pre-intervention and post-intervention. Additionally, rates of parents’ behaviors were compared between those that interacted with HCPs before training to those interacting with HCPs post-intervention.
Effect sizes indicated that HCPs that underwent training demonstrated increases in rates of desired behaviors (range: 0.22 to 1.49) and decreases in rates of undesired behaviors (range: 0.15 to 2.15). Additionally, parents, who were indirectly trained, also demonstrated changes to their rates of desired (range: 0.30 to 0.60) and undesired behaviors (range: 0.16 to 0.61).
The intervention successfully modified HCP and parent behaviors. It represents a potentially new clinical way to decrease anxiety in children. A recently National Institute of Child Health and Development funded multi-site randomized control trial will examine the efficacy of this intervention in reducing children’s preoperative anxiety and improving children’s postoperative recovery is about to start.
PMCID: PMC3124404  PMID: 21606826
6.  Factors Explaining Children’s Responses to Intravenous Needle Insertions 
Nursing research  2010;59(6):407-416.
Previous research shows that numerous child, parent, and procedural variables affect children’s distress responses to procedures. Cognitive-behavioral interventions such as distraction are effective in reducing pain and distress for many children undergoing these procedures.
The purpose of this report was to examine child, parent, and procedural variables that explain child distress during a scheduled intravenous insertion when parents are distraction coaches for their children.
A total of 542 children, between 4 and 10 years of age, and their parents participated. Child age, gender, diagnosis, and ethnicity were measured by questions developed for this study. Standardized instruments were used to measure child experience with procedures, temperament, ability to attend, anxiety, coping style, and pain sensitivity. Questions were developed to measure parent variables, including ethnicity, gender, previous experiences, and expectations, and procedural variables, including use of topical anesthetics and difficulty of procedure. Standardized instruments were used to measure parenting style and parent anxiety, whereas a new instrument was developed to measure parent performance of distraction. Children’s distress responses were measured with the Observation Scale of Behavioral Distress–Revised (behavioral), salivary cortisol (biological), Oucher Pain Scale (self-report), and parent report of child distress (parent report). Regression methods were used for data analyses.
Variables explaining behavioral, child-report and parent-report measures include child age, typical coping response, and parent expectation of distress (p < .01). Level of parents’ distraction coaching explained a significant portion of behavioral, biological, and parent-report distress measures (p < .05). Child impulsivity and special assistance at school also significantly explained child self-report of pain (p < .05). Additional variables explaining cortisol response were child’s distress in the morning before clinic, diagnoses of attention deficit hyperactivity disorder or anxiety disorder, and timing of preparation for the clinic visit.
The findings can be used to identify children at risk for high distress during procedures. This is the first study to find a relationship between child behavioral distress and level of parent distraction coaching.
PMCID: PMC3546606  PMID: 20962698
children; cortisol; distress; distraction; pain
7.  Parents and paediatric anaesthesia: a prospective survey of parental attitudes to their presence at induction. 
Parental presence at induction of anaesthesia is controversial and of disputed value. Ninety out of 117 parents replied to a preoperative questionnaire designed to identify their preference and motivation with regard to accompanying their children to the anaesthetic room. Half the parents wished to be present at induction, irrespective of the child's age or previous surgical experience and the most commonly cited reasons for this were the child's anxiety or the parents' sense of duty; 32% of these parents changed their preference if their child were to be adequately sedated preoperatively. In addition, 18% of all parents felt that they would prefer not to be present at induction. The results suggest that in circumstances where parents are to be excluded from induction, adequate preoperative explanation and sedative premedication would contribute to allaying parental anxiety, but that a flexible policy may be most appropriate.
PMCID: PMC2499078  PMID: 2301901
8.  Preanesthetic medication in children: A comparison of intranasal dexmedetomidine versus oral midazolam 
Saudi Journal of Anaesthesia  2011;5(4):387-391.
Relieving preoperative anxiety is an important concern for the pediatric anesthesiologist. Midazolam has become the most frequently used premedication in children. However, new drugs such as the α2 -agonists have emerged as alternatives for premedication in pediatric anesthesia.
One hundred and twenty children scheduled for adenotonsillectomy were enrolled in this prospective, double-blind, randomized study. The children were divided into two equal groups to receive either intranasal dexmedetomidine 1 μg/kg (group D), or oral midazolam 0.5 mg/kg (group M) at approximately 60 and 30 mins, respectively, before induction of anesthesia. Preoperative sedative effects, anxiety level changes, and the ease of child-parent separation were assessed. Also, the recovery profile and postoperative analgesic properties were assessed.
Children premedicated with intranasal dexmedetomidine achieved significantly lower sedation levels (P=0.042), lower anxiety levels (P=0.036), and easier child-parent separation (P=0.029) than children who received oral midazolam at the time of transferring the patients to the operating room. Postoperatively, the time to achieve an Aldrete score of 10 was similar in both the groups (P=0.067). Also, the number of children who required fentanyl as rescue analgesia medication was significantly less (P=0.027) in the dexmedetomidine group.
Intranasal dexmedetomidine appears to be a better choice for preanesthetic medication than oral midazolam in our study. Dexmedetomidine was associated with lower sedation levels, lower anxiety levels, and easier child-parent separation at the time of transferring patients to the operating room than children who received oral midazolam. Moreover, intranasal dexmedetomidine has better analgesic property than oral midazolam with discharge time from postanesthetic care unit similar to oral midazolam.
PMCID: PMC3227308  PMID: 22144926
Dexmedetomidine; midazolam; pediatric; sedation
9.  Family-based behavioural intervention programme for obese children: a feasibility study 
BMJ Open  2012;2(2):e000268.
To assess a 2-year family-based behavioural intervention programme against child obesity.
Single-group pre- and post-intervention feasibility study.
Swedish paediatric outpatient care.
26 obese children aged 8.3–12.0 years and their parents who had consented to actively participate in a 2-year intervention.
25 paediatric outpatient group sessions over a 2-year period with parallel groups for children and parents. The basis for the programme was a manual containing instructions for tutor-supervised group sessions with obese children and their parents.
Primary and secondary outcome measures
The primary outcome measure was change in standardised body mass index between baseline and after 36 months. The secondary outcome measures were change in the waist:height ratio, metabolic parameters and programme adherence. The participants were examined at baseline and after 3, 12 and 24 months of therapy and at follow-up 12 months after completion of the programme.
The primary outcome measure, standardised body mass index, declined from a mean of 3.3 (0.7 SD) at baseline to 2.9 (0.7 SD) (p<0.001) at follow-up 12 months after completion of the programme. There was no change in the waist:height ratio. Biomedical markers of blood glucose metabolism and lipid status remained in the normal range. 96% of the families completed the programme.
This feasibility study of a 2-year family-based behavioural intervention programme in paediatric outpatient care showed promising results with regard to further weight gain and programme adherence. These findings must be confirmed in a randomised controlled trial with longer follow-up before the intervention programme can be implemented on a larger scale.
Article summary
Article focus
Family-based behavioural interventions have produced promising results in controlled studies, but their effectiveness in paediatric outpatient settings remains to be shown.
Key messages
A 2-year family-based behavioural intervention programme for the management of childhood obesity in paediatric outpatient care showed promising results with regard to weight gain 1 year after the programme.
The completion rate of the programme was high, which is important as high family adherence is a success factor for childhood obesity therapy.
Strengths and limitations of this study
The main methodological strengths of this study are that the primary end point measurement was performed 12 months after completion of the long-term intervention programme and that all participants were included in the data analysis at the study end point whether or not they had completed the intervention.
The major weaknesses of the study are the small study sample and single-group design. The design implies that the observed decline in standardised body mass index cannot be firmly interpreted as an effect of the intervention programme. The results would have been even more convincing if all the secondary outcome measures had displayed similar trends. Longer follow-up than 12 months is necessary to examine sustainable effects of the intervention.
PMCID: PMC3293142  PMID: 22389357
10.  Preventing alcohol misuse in young people aged 9-11 years through promoting family communication: an exploratory evaluation of the Kids, Adults Together (KAT) Programme 
BMC Public Health  2011;11:810.
Alcohol misuse by young people is an important public health issue, and has led to the development of a range of prevention interventions. Evidence concerning the most effective approaches to intervention design and implementation is limited. Parental involvement in school-based interventions is important, but many programmes fail to recruit large numbers of parents. This paper reports findings from an exploratory evaluation of a new alcohol misuse prevention programme - Kids, Adults Together (KAT), which comprised a classroom component, engagement with parents through a fun evening for families with children aged 9-11 years, and a DVD. The evaluation aimed to establish the programme's theoretical basis, explore implementation processes and acceptability, and identify plausible precursors of the intended long-term outcomes.
Documentary analysis and interviews with key personnel examined the programme's development. Classroom preparation and KAT family events in two schools were observed. Focus groups with children, and interviews with parents who attended KAT family events were held immediately after programme delivery, and again after three months. Interviews with head teachers and with teachers who delivered the classroom preparation were conducted. Follow-up interviews with programme personnel were undertaken. Questionnaires were sent to parents of all children involved in classroom preparation.
KAT achieved high levels of acceptability and involvement among both children and parents. Main perceived impacts of the programme were increased pro-social communication within families (including discussions about harmful parental alcohol consumption), heightened knowledge and awareness of the effects of alcohol consumption and key legal and health issues, and changes in parental drinking behaviours.
KAT demonstrated promise as a prevention intervention, primarily through its impact on knowledge and communication processes within families, and its ability to engage with large numbers of parents. A key programme mechanism was the classroom preparation's facilitation of parental involvement in the family fun evening. The programme also incorporated features identified in the literature as likely to increase effectiveness, including a focus on harm reduction, interactive delivery, and targeting primary-school-age children. Further research is needed to test and develop programme theory through implementation in different school contexts, and to examine potential longer-term impacts, and the feasibility of large scale delivery.
PMCID: PMC3214894  PMID: 22004185
11.  Measuring the impact and costs of a universal group based parenting programme: protocol and implementation of a trial 
BMC Public Health  2010;10:364.
Sub-optimal parenting is a common risk factor for a wide range of negative health, social and educational outcomes. Most parenting programmes have been developed in the USA in the context of delinquency prevention for targeted or indicated groups and the main theoretical underpinning for these programmes is behaviour management. The Family Links Nurturing Programme (FLNP) focuses on family relationships as well as behaviour management and is offered on a universal basis. As a result it may be better placed to improve health and educational outcomes. Developed in the UK voluntary sector, FLNP is popular with practitioners, has impressed policy makers throughout the UK, has been found to be effective in before/after and qualitative studies, but lacks a randomised controlled trial (RCT) evidence base.
A multi-centre, investigator blind, randomised controlled trial of the FLNP with a target sample of 288 south Wales families who have a child aged 2-4 yrs living in or near to Flying Start/Sure Start areas. Changes in parenting, parent child relations and parent and child wellbeing are assessed with validated measures immediately and at 6 months post intervention. Economic components include cost consequences and cost utility analyses based on parental ranking of states of quality of life. Attendance and completion rates and fidelity to the FLNP course delivery are assessed. A nested qualitative study will assess reasons for participation and non-participation and the perceived value of the programme to families. By the end of May 2010, 287 families have been recruited into the trial across four areas of south Wales. Recruitment has not met the planned timescales with barriers including professional anxiety about families entering the control arm of the trial, family concern about video and audio recording, programme facilitator concern about the recording of FLNP sessions for fidelity purposes and delays due to the new UK research governance procedures.
Whilst there are strong theoretical arguments to support universal provision of parenting programmes, few universal programmes have been subjected to randomised controlled trials. In this paper we describe a RCT protocol with quantitative and qualitative outcome measures and an economic evaluation designed to provide clear evidence with regard to effectiveness and costs. We describe challenges implementing the protocol and how we are addressing these.
Trial Registration
Current Controlled Trials ISRCTN13919732
PMCID: PMC2905332  PMID: 20573236
12.  Effect of a family focused active play intervention on sedentary time and physical activity in preschool children 
Early childhood provides a window of opportunity for the promotion of physical activity. Given the limited effectiveness of interventions to date, new approaches are needed. Socio-ecological models suggest that involving parents as intervention targets may be effective in fostering healthier lifestyles in children. This study describes the effectiveness of a family-focused ‘Active Play’ intervention in decreasing sedentary time and increasing total physical activity in preschool children.
Seventy-seven families were recruited from 8 randomly selected SureStart children’s centres in the North West of England. Centres were randomly assigned to either an intervention (n = 4) or a comparison group (n = 4). Parents and children in the intervention group received a 10-week active play programme delivered by trained active play professionals; this included an activity and educational component. Families in the comparison group were asked to maintain their usual routine. Each participating parent and child wore a uni-axial accelerometer for 7 days at baseline and post-test. Week and weekend day sedentary time and total physical activity adjusted for child- and home- level covariates were analysed using multilevel analyses.
Significant intervention effects were observed for sedentary time and physical activity for both week and weekend days. Children in the intervention group engaged in 1.5% and 4.3% less sedentary time during week and weekend days, respectively and 4.5% and 13.1% more physical activity during week and weekend days, respectively than children in the comparison group. Parent’s participation in sport and their physical activity levels, child’s sex, availability of media in the home and attendance at organised activities were significant predictors of sedentary time and physical activity in this age group.
A 10-week family focused active play intervention produced positive changes in sedentary time and total physical activity levels in preschool children. Specific covariates were identified as having a significant effect on the outcome measures. Moreover, children whose parents were active engaged in less sedentary time and more physical activity suggesting that parent’s activity habits are mediators of physical activity engagement in this age group.
PMCID: PMC3495835  PMID: 23025568
Preschool children; Parent involvement; Active play; Physical activity; Sedentary time; Accelerometry; Intervention; Multi-level analysis
13.  An evaluation of the parents under pressure programme: a study protocol for an RCT into its clinical and cost effectiveness 
Trials  2013;14:210.
Many babies in the UK are born to drug-dependent parents, and dependence on psychoactive drugs during the postnatal period is associated with high rates of child maltreatment, with around a quarter of these children being subject to a child protection plan. Parents who are dependent on psychoactive drugs are at risk of a wide range of parenting problems, and studies have found reduced sensitivity and responsiveness to both the infant’s physical and emotional needs. The poor outcomes that are associated with such drug dependency appear to be linked to the multiple difficulties experienced by such parents.
An increase in understanding about the crucial importance of early relationships for infant well-being has led to a focus on the development and delivery of services that are aimed at supporting parenting and parent–infant interactions. The Parents under Pressure (PuP) programme is aimed at supporting parents who are dependent on psychoactive drugs or alcohol by providing them with methods of managing their emotional regulation, and of supporting their new baby’s development. An evaluation of the PuP programme in Australia with parents on methadone maintenance of children aged 3 to 8 years found significant reductions in child abuse potential, rigid parenting attitudes and child behaviour problems.
The study comprises a multicentre randomised controlled trial using a mixed-methods approach to data collection and analysis in order to identify which families are most able to benefit from this intervention.
The study is being conducted in six family centres across the UK, and targets primary caregivers of children less than 2.5 years of age who are substance dependent. Consenting participants are randomly allocated to either the 20-week PuP programme or to standard care.
The primary outcome is child abuse potential, and secondary outcomes include substance use, parental mental health and emotional regulation, parenting stress, and infant/toddler socio-emotional adjustment scale.
This is one the first UK studies to examine the effectiveness of a programme targeting the parenting of substance-dependent parents of infants and toddlers, in terms of its effectiveness in improving the parent–infant relationship and reducing the potential for child abuse.
Trial registration
International Standard Randomised Controlled Trial Number Register: ISRCTN47282925
PMCID: PMC3717037  PMID: 23841920
Parenting; Substance misuse; Drug abuse; Alcohol abuse; Infants; Parents under pressure
14.  Oral health-related quality of life after dental general anaesthesia treatment among children: a follow-up study 
BMC Oral Health  2014;14:81.
Many young paediatric patients with severe dental caries receive dental treatment under general anaesthesia. Oral health-related quality of life (OHRQoL) can be evaluated to assess the outcome of dental general anaesthesia (DGA) treatment. The aim of our study was to examine the OHRQoL of young Lithuanian children in need of DGA treatment and analyse the impact of DGA treatment on children’s OHRQoL.
We carried out a prospective clinical follow-up study on OHRQoL among all young Lithuanian child patients who received DGA treatment at the Lithuanian University of Health Sciences Hospital during 2010–2012. The study consisted of clinical dental examinations of patients younger than six years, data collected from their patient files, and an OHRQoL survey completed by their parents prior to the child’s dental treatment. We conducted a follow-up OHRQoL survey one month after the DGA treatment. The Early Childhood Oral Health Impact Scale (ECOHIS) and its effect size (ES) served to evaluate children’s OHRQoL, and the Wilcoxon signed-rank test served for statistical analyses.
We obtained complete baseline and follow-up data for 140 and 122 participants, respectively (84.7% follow-up rate). Pain and eating problems among children and parents feeling upset and guilty were the most frequently reported impacts at baseline. The parents reported greater impacts on boys than on girls. The ECOHIS score decreased significantly (69.5%, p < 0.001) after DGA treatment, revealing a large ES for the child (1.6) and family (2.4) sections of the ECOHIS.
The OHRQoL of young Lithuanian children requiring DGA treatment is seriously impaired. Dental general anaesthesia treatment results in significant improvement of the children’s OHRQoL. The children’s parents also greatly appreciate this treatment modality for its positive impact on the family’s quality of life.
PMCID: PMC4090347  PMID: 24984901
Dental general anaesthesia; Oral health-related quality of life; Children; Follow-up
15.  Bidirectional Associations Between Coparenting Relations and Family Member Anxiety: A Review and Conceptual Model 
Research into anxiety has largely ignored the dynamics of family systems in anxiety development. Coparenting refers to the quality of coordination between individuals responsible for the upbringing of children and links different subsystems within the family, such as the child, the marital relationship, and the parents. This review discusses the potential mechanisms and empirical findings regarding the bidirectional relations of parent and child anxiety with coparenting. The majority of studies point to bidirectional associations between greater coparenting difficulties and higher levels of anxiety. For example, the few available studies suggest that paternal and perhaps maternal anxiety is linked to lower coparental support. Also, research supports the existence of inverse links between coparenting quality and child anxiety. A child’s reactive temperament appears to have adverse effects on particularly coparenting of fathers. A conceptual model is proposed that integrates the role of parental and child anxiety, parenting, and coparenting, to guide future research and the development of clinical interventions. Future research should distinguish between fathers’ and mothers’ coparenting behaviors, include parental anxiety, and investigate the coparental relationship longitudinally. Clinicians should be aware of the reciprocal relations between child anxiety and coparenting quality, and families presenting for treatment who report child (or parent) anxiety should be assessed for difficulties in coparenting. Clinical approaches to bolster coparenting quality are called for.
PMCID: PMC3282913  PMID: 22124791
Coparenting; Child anxiety; Parental anxiety; Support; Undermining
16.  Preventive Intervention for Anxious Preschoolers and Their Parents: Strengthening Early Emotional Development 
The high prevalence and early onset of anxiety disorders have inspired innovative prevention efforts targeting young at-risk children. With parent–child prevention models showing success for older children and adolescents, the goal of this study was to evaluate a parent–child indicated preventive intervention for preschoolers with mild to moderate anxiety symptoms. Sixteen children (ages 3–5) and at least one of their parents participated in Strengthening Early Emotional Development (SEED), a new 10-week intervention with concurrent groups for parents and children. Outcome measures included clinician-rated and parent-rated assessments of anxiety symptoms, as well as measures of emotion knowledge, parent anxiety, and parental attitudes about children’s anxiety. Participation in SEED was associated with reduced child anxiety symptoms and improved emotion understanding skills. Parents reported decreases in their own anxiety, along with attitudes reflecting enhanced confidence in their children’s ability to cope with anxiety. Reductions in child and parent anxiety were maintained at 3-month follow-up. Findings suggest that a parent–child cognitive-behavioral preventive intervention may hold promise for young children with mild to moderate anxiety. Improvements in parent anxiety and parental attitudes may support the utility of intervening with parents. Fostering increased willingness to encourage their children to engage in new and anxiety-provoking situations may help promote continued mastery of new skills and successful coping with anxiety.
PMCID: PMC3759969  PMID: 22331442
Child anxiety; Parent anxiety; Indicated prevention
17.  Preoperative anxiolysis in pediatric population: A comparative study between oral midazolam and oral ketamine 
Preoperative anxiety is synonymous with pediatric surgery. Anxiolysis is of crucial importance and poses a significant challenge to the pediatric anesthesiologist. Orally administered midazolam and ketamine can be used as anxiolytic premedication in children.
To compare the efficacy of orally administered midazolam and ketamine for preoperative sedation and anxiolysis in children and determine the minimum interval required between premedication and parental separation.
Setting and Design:
Prospective, randomized, double-blind study.
Materials and Methods:
A total of 70 children aged 2-8 years, belonging to ASA grade 1 and 2, scheduled to undergo elective infraumbilical and peripheral surgeries were randomized into two groups of 35 each to receive either midazolam (0.5 mg/kg) or ketamine (5 mg/kg) orally. They were assessed at an interval of 5 minutes up to 40 minutes, at the time of parental separation, intravenous cannulation, and application of face mask for ventilation. Sedation was noted according to Ramsay Sedation Scale and anxiolysis was noted according to Anxiolysis Scores used in previous published studies.
Statistical Analysis Used:
Skewed data between groups were analyzed by Mann Whitney U Test. Data within a group were analyzed using Friedman's Analysis of variance and a post hoc test.
No statistically significant difference in sedation and anxiolysis scores were obtained between the groups at any point of time. Maximum sedation score was achieved at 20 minutes in both the groups, with no statistically significant difference with scores obtained thereafter. Statistically significant difference occurred in anxiolysis score at study points in group receiving midazolam.
The study documents the rapid achievement of preoperative sedation and anxiolysis in children with orally administered midazolam or ketamine, with the latter producing a superior quality of anxiolysis. An interval of 20 minutes is sufficient between premedication and parental separation.
PMCID: PMC4173508
Anxiolysis; ketamine; midazolam; oral; sedation
18.  Non-Specialist Psychosocial Interventions for Children and Adolescents with Intellectual Disability or Lower-Functioning Autism Spectrum Disorders: A Systematic Review 
PLoS Medicine  2013;10(12):e1001572.
In a systematic review, Brian Reichow and colleagues assess the evidence that non-specialist care providers in community settings can provide effective interventions for children and adolescents with intellectual disabilities or lower-functioning autism spectrum disorders.
Please see later in the article for the Editors' Summary
The development of effective treatments for use by non-specialists is listed among the top research priorities for improving the lives of people with mental illness worldwide. The purpose of this review is to appraise which interventions for children with intellectual disabilities or lower-functioning autism spectrum disorders delivered by non-specialist care providers in community settings produce benefits when compared to either a no-treatment control group or treatment-as-usual comparator.
Methods and Findings
We systematically searched electronic databases through 24 June 2013 to locate prospective controlled studies of psychosocial interventions delivered by non-specialist providers to children with intellectual disabilities or lower-functioning autism spectrum disorders. We screened 234 full papers, of which 34 articles describing 29 studies involving 1,305 participants were included. A majority of the studies included children exclusively with a diagnosis of lower-functioning autism spectrum disorders (15 of 29, 52%). Fifteen of twenty-nine studies (52%) were randomized controlled trials and just under half of all effect sizes (29 of 59, 49%) were greater than 0.50, of which 18 (62%) were statistically significant. For behavior analytic interventions, the best outcomes were shown for development and daily skills; cognitive rehabilitation, training, and support interventions were found to be most effective for improving developmental outcomes, and parent training interventions to be most effective for improving developmental, behavioral, and family outcomes. We also conducted additional subgroup analyses using harvest plots. Limitations include the studies' potential for performance bias and that few were conducted in lower- and middle-income countries.
The findings of this review support the delivery of psychosocial interventions by non-specialist providers to children who have intellectual disabilities or lower-functioning autism spectrum disorders. Given the scarcity of specialists in many low-resource settings, including many lower- and middle-income countries, these findings may provide guidance for scale-up efforts for improving outcomes for children with developmental disorders or lower-functioning autism spectrum disorders.
Protocol Registration
PROSPERO CRD42012002641
Please see later in the article for the Editors' Summary
Editors' Summary
Newborn babies are helpless, but over the first few years of life, they acquire motor (movement) skills, language (communication) skills, cognitive (thinking) skills, and social (interpersonal interaction) skills. Individual aspects of these skills are usually acquired at specific ages, but children with a development disorder such as an autism spectrum disorder (ASD) or intellectual disability (mental retardation) fail to reach these “milestones” because of impaired or delayed brain maturation. Autism, Asperger syndrome, and other ASDs (also called pervasive developmental disorders) affect about 1% of the UK and US populations and are characterized by abnormalities in interactions and communication with other people (reciprocal socio-communicative interactions; for example, some children with autism reject physical affection and fail to develop useful speech) and a restricted, stereotyped, repetitive repertoire of interests (for example, obsessive accumulation of facts about unusual topics). About half of individuals with an ASD also have an intellectual disability—a reduced overall level of intelligence characterized by impairment of the skills that are normally acquired during early life. Such individuals have what is called lower-functioning ASD.
Why Was This Study Done?
Most of the children affected by developmental disorders live in low- and middle-income countries where there are few services available to help them achieve their full potential and where little research has been done to identify the most effective treatments. The development of effective treatments for use by non-specialists (for example, teachers and parents) is necessary to improve the lives of people with mental illnesses worldwide, but particularly in resource-limited settings where psychiatrists, psychologists, and other specialists are scarce. In this systematic review, the researchers investigated which psychosocial interventions for children and adolescents with intellectual disabilities or lower-functioning ASDs delivered by non-specialist providers in community settings produce improvements in development, daily skills, school performance, behavior, or family outcomes when compared to usual care (the control condition). A systematic review identifies all the research on a given topic using predefined criteria; psychosocial interventions are defined as therapy, education, training, or support aimed at improving behavior, overall development, or specific life skills without the use of drugs.
What Did the Researchers Do and Find?
The researchers identified 29 controlled studies (investigations with an intervention group and a control group) that examined the effects of various psychosocial interventions delivered by non-specialist providers to children (under 18 years old) who had a lower-functioning ASD or intellectual disability. The researchers retrieved information on the participants, design and methods, findings, and intervention characteristics for each study, and calculated effect sizes—a measure of the effectiveness of a test intervention relative to a control intervention—for several outcomes for each intervention. Across the studies, three-quarters of the effect size estimates were positive, and nearly half were greater than 0.50; effect sizes of less than 0.2, 0.2–0.5, and greater than 0.5 indicate that an intervention has no, a small, or a medium-to-large effect, respectively. For behavior analytic interventions (which aim to improve socially significant behavior by systematically analyzing behavior), the largest effect sizes were seen for development and daily skills. Cognitive rehabilitation, training, and support (interventions that facilitates the relearning of lost or altered cognitive skills) produced good improvements in developmental outcomes such as standardized IQ tests in children aged 6–11 years old. Finally, parental training interventions (which teach parents how to provide therapy services for their child) had strong effects on developmental, behavioral, and family outcomes.
What Do These Findings Mean?
Because few of the studies included in this systematic review were undertaken in low- and middle-income countries, the review's findings may not be generalizable to children living in resource-limited settings. Moreover, other characteristics of the included studies may limit the accuracy of these findings. Nevertheless, these findings support the delivery of psychosocial interventions by non-specialist providers to children who have intellectual disabilities or a lower-functioning ASD, and indicate which interventions are likely to produce the largest improvements in developmental, behavioral, and family outcomes. Further studies are needed, particularly in low- and middle-income countries, to confirm these findings, but given that specialists are scarce in many resource-limited settings, these findings may help to inform the implementation of programs to improve outcomes for children with intellectual disabilities or lower-functioning ASDs in low- and middle-income countries.
Additional Information
Please access these websites via the online version of this summary at
This study is further discussed in a PLOS Medicine Perspective by Bello-Mojeed and Bakare
The US Centers for Disease Control and Prevention provides information (in English and Spanish) on developmental disabilities, including autism spectrum disorders and intellectual disability
The US National Institute of Mental Health also provides detailed information about autism spectrum disorders, including the publication “A Parent's Guide to Autism Spectrum Disorder”
Autism Speaks, a US non-profit organization, provides information about all aspects of autism spectrum disorders and includes information on the Autism Speaks Global Autism Public Health Initiative
The National Autistic Society, a UK charity, provides information about all aspects of autism spectrum disorders and includes personal stories about living with these conditions
The UK National Health Service Choices website has an interactive guide to child development and information about autism and Asperger syndrome, including personal stories, and about learning disabilities
The UK National Institute for Health and Care Excellence provides clinical guidelines for the management and support of children with autism spectrum disorders
The World Health Organization provides information on its Mental Health Gap Action Programme (mhGAP), which includes recommendations on the management of developmental disorders by non-specialist providers; the mhGAP Evidence Resource Center provides evidence reviews for parent skills training for management of children with intellectual disabilities and pervasive developmental disorders and interventions for management of children with intellectual disabilities
PROSPERO, an international prospective register of systematic reviews, provides more information about this systematic review
PMCID: PMC3866092  PMID: 24358029
19.  Study protocol: evaluation of a parenting and stress management programme: a randomised controlled trial of Triple P Discussion Groups and Stress Control 
BMC Public Health  2013;13:888.
Children displaying psychosocial problems are at an increased risk of negative developmental outcomes. Parenting practices are closely linked with child development and behaviour, and parenting programmes have been recommended in the treatment of child psychosocial problems. However, parental mental health also needs to be addressed when delivering parenting programmes as it is linked with parenting practices, child outcomes, and treatment outcomes of parenting programmes. This paper describes the protocol of a study examining the effects of a combined intervention of a parenting programme and a cognitive behavioural intervention for mental health problems.
The effects of a combined intervention of Triple P Discussion Groups and Stress Control will be examined using a randomised controlled trial design. Parents with a child aged 3–8 years will be recruited to take part in the study. After obtaining informed consent and pre-intervention measures, participants will be randomly assigned to either an intervention or a waitlist condition. The two primary outcomes for this study are change in dysfunctional/ineffective parenting practices and change in symptoms of depression, anxiety, and stress. Secondary outcomes are child behaviour problems, parenting experiences, parental self-efficacy, family relationships, and positive parental mental health. Demographic information, participant satisfaction with the intervention, and treatment fidelity data will also be collected. Data will be collected at pre-intervention, mid-intervention, post-intervention, and 3-month follow-up.
The aim of this paper is to describe the study protocol of a randomised controlled trial evaluating the effects of a combined intervention of Triple P Discussion Groups and Stress Control in comparison to a waitlist condition. This study is important because it will provide evidence about the effects of this combined intervention for parents with 3–8 year old children. The results of the study could be used to inform policy about parenting support and support for parents with mental health problems.
Trial registration NCT01777724, UTN: U1111-1137-1053.
PMCID: PMC3852548  PMID: 24066966
20.  Barriers to Provider-Initiated Testing and Counselling for Children in a High HIV Prevalence Setting: A Mixed Methods Study 
PLoS Medicine  2014;11(5):e1001649.
Rashida Ferrand and colleagues combine quantitative and qualitative methods to investigate HIV prevalence among older children receiving primary care in Harare, Zimbabwe, and reasons why providers did not pursue testing.
Please see later in the article for the Editors' Summary
There is a substantial burden of HIV infection among older children in sub-Saharan Africa, the majority of whom are diagnosed after presentation with advanced disease. We investigated the provision and uptake of provider-initiated HIV testing and counselling (PITC) among children in primary health care facilities, and explored health care worker (HCW) perspectives on providing HIV testing to children.
Methods and Findings
Children aged 6 to 15 y attending six primary care clinics in Harare, Zimbabwe, were offered PITC, with guardian consent and child assent. The reasons why testing did not occur in eligible children were recorded, and factors associated with HCWs offering and children/guardians refusing HIV testing were investigated using multivariable logistic regression. Semi-structured interviews were conducted with clinic nurses and counsellors to explore these factors. Among 2,831 eligible children, 2,151 (76%) were offered PITC, of whom 1,534 (54.2%) consented to HIV testing. The main reasons HCWs gave for not offering PITC were the perceived unsuitability of the accompanying guardian to provide consent for HIV testing on behalf of the child and lack of availability of staff or HIV testing kits. Children who were asymptomatic, older, or attending with a male or a younger guardian had significantly lower odds of being offered HIV testing. Male guardians were less likely to consent to their child being tested. 82 (5.3%) children tested HIV-positive, with 95% linking to care. Of the 940 guardians who tested with the child, 186 (19.8%) were HIV-positive.
The HIV prevalence among children tested was high, highlighting the need for PITC. For PITC to be successfully implemented, clear legislation about consent and guardianship needs to be developed, and structural issues addressed. HCWs require training on counselling children and guardians, particularly male guardians, who are less likely to engage with health care services. Increased awareness of the risk of HIV infection in asymptomatic older children is needed.
Please see later in the article for the Editors' Summary
Editors' Summary
Over 3 million children globally are estimated to be living with HIV (the virus that causes AIDS). While HIV infection is most commonly spread through unprotected sex with an infected person, most HIV infections among children are the result of mother-to-child HIV transmission during pregnancy, delivery, or breastfeeding. Mother-to-child transmission can be prevented by administering antiretroviral therapy to mothers with HIV during pregnancy, delivery, and breast feeding, and to their newborn babies. According to a report by the Joint United Nations Programme on HIV/AIDS published in 2012, 92% of pregnant women with HIV were living in sub-Saharan Africa and just under 60% were receiving antiretroviral therapy. Consequently, sub-Saharan Africa is the region where most children infected with HIV live.
Why Was This Study Done?
If an opportunity to prevent mother-to-child transmission around the time of birth is missed, diagnosis of HIV infection in a child or adolescent is likely to depend on HIV testing in health care facilities. Health care provider–initiated HIV testing and counselling (PITC) for children is important in areas where HIV infection is common because earlier diagnosis allows children to benefit from care that can prevent the development of advanced HIV disease. Even if a child or adolescent appears to be in good health, access to care and antiretroviral therapy provides a health benefit to the individual over the long term. The administration of HIV testing (and counselling) to children relies not only on health care workers (HCWs) offering HIV testing but also on parents or guardians consenting for a child to be tested. However, more than 30% of children in countries with severe HIV epidemics are AIDS orphans, and economic conditions in these countries cause many adults to migrate for work, leaving children under the care of extended families. This study aimed to investigate the reasons for acceptance and rejection of PITC in primary health care settings in Harare, Zimbabwe. By exploring HCW perspectives on providing HIV testing to children and adolescents, the study also sought to gain insight into factors that could be hindering implementation of testing procedures.
What Did the Researchers Do and Find?
The researchers identified all children aged 6 to 15 years old at six primary care clinics in Harare, who were offered HIV testing as part of routine care between 22 January and 31 May 2013. Study fieldworkers collected data on numbers of child attendances, numbers offered testing, numbers who underwent HIV testing, and reasons why HIV testing did not occur. During the study 2,831 children attending the health clinics were eligible for PITC, and just over half (1,534, 54.2%) underwent HIV testing. Eighty-two children tested HIV-positive, and nearly all of them received counselling, medication, and follow-up care. HCWs offered the test to around 75% of those eligible. The most frequent explanation given by HCWs for a diagnostic test not being offered was that the child was accompanied by a guardian not appropriate for providing consent (401 occasions, 59%); Other reasons given were a lack of available counsellors or test kits and counsellors refusing to conduct the test. The likelihood of being offered the test was lower for children not exhibiting symptoms (such as persistent skin problems), older children, or those attending with a male or a younger guardian. In addition, over 100 guardians or parents provided consent but left before the child could be tested.
The researchers also conducted semi-structured interviews with 12 clinic nurses and counsellors (two from each clinic) to explore challenges to implementation of PITC. The researchers recorded the factors associated with testing not taking place, either when offered to eligible children or when HCWs declined to offer the test. The interviewees identified the frequent absence or unavailability of parents or legal guardians as an obstacle, and showed uncertainty or misconceptions around whether testing of the guardian was mandatory (versus recommended) and whether specifically a parent (if one was living) must provide consent. The interviews also revealed HCW concerns about the availability of adequate counselling and child services, and fears that a child might experience maltreatment if he or she tested positive. HCWs also noted long waiting times and test kits being out of stock as practical hindrances to testing.
What Do These Findings Mean?
Prevalence of HIV was high among the children tested, validating the need for PITC in sub-Saharan health care settings. Although 76% of eligible attendees were offered testing, the authors note that this is likely higher than in routine settings because the researchers were actively recording reasons for not offering testing and counselling, which may have encouraged heath care staff to offer PITC more often than usual. The researchers outline strategies that may improve PITC rates and testing acceptance for Zimbabwe and other sub-Saharan settings. These strategies include developing clear laws and guidance concerning guardianship and proxy consent when testing older children for HIV, training HCWs around these policies, strengthening legislation to address discrimination, and increasing public awareness about HIV infection in older children.
Additional Information
Please access these websites via the online version of this summary at
This study is further discussed in a PLOS Medicine Perspective by Davies and Kalk
The Joint United Nations Programme on HIV/AIDS publishes an annual report on the global AIDS epidemic, which provides information on progress towards eliminating new HIV infections
The World Health Organization has more information on mother-to-child transmission of HIV
The World Health Organization's website also has information about treatment for children living with HIV
Personal stories about living with HIV/AIDS, including stories from young people infected with HIV, are available through Avert, through NAM/aidsmap, and through the charity website Healthtalkonline
PMCID: PMC4035250  PMID: 24866209
21.  Randomised cluster trial to support informed parental decision-making for the MMR vaccine 
BMC Public Health  2011;11:475.
In the UK public concern about the safety of the combined measles, mumps and rubella [MMR] vaccine continues to impact on MMR coverage. Whilst the sharp decline in uptake has begun to level out, first and second dose uptake rates remain short of that required for population immunity. Furthermore, international research consistently shows that some parents lack confidence in making a decision about MMR vaccination for their children. Together, this work suggests that effective interventions are required to support parents to make informed decisions about MMR.
This trial assessed the impact of a parent-centred, multi-component intervention (balanced information, group discussion, coaching exercise) on informed parental decision-making for MMR.
This was a two arm, cluster randomised trial. One hundred and forty two UK parents of children eligible for MMR vaccination were recruited from six primary healthcare centres and six childcare organisations. The intervention arm received an MMR information leaflet and participated in the intervention (parent meeting). The control arm received the leaflet only. The primary outcome was decisional conflict. Secondary outcomes were actual and intended MMR choice, knowledge, attitude, concern and necessity beliefs about MMR and anxiety.
Decisional conflict decreased for both arms to a level where an 'effective' MMR decision could be made one-week (effect estimate = -0.54, p < 0.001) and three-months (effect estimate = -0.60, p < 0.001) post-intervention. There was no significant difference between arms (effect estimate = 0.07, p = 0.215). Heightened decisional conflict was evident for parents making the MMR decision for their first child (effect estimate = -0.25, p = 0.003), who were concerned (effect estimate = 0.07, p < 0.001), had less positive attitudes (effect estimate = -0.20, p < 0.001) yet stronger intentions (effect estimate = 0.09, p = 0.006). Significantly more parents in the intervention arm reported vaccinating their child (93% versus 73%, p = 0.04).
Whilst both the leaflet and the parent meeting reduced parents' decisional conflict, the parent meeting appeared to enable parents to act upon their decision leading to vaccination uptake.
PMCID: PMC3144460  PMID: 21679432
22.  Multicentre controlled trial of parenting groups for childhood antisocial behaviour in clinical practice 
BMJ : British Medical Journal  2001;323(7306):194.
To see whether a behaviourally based group parenting programme, delivered in regular clinical practice, is an effective treatment for antisocial behaviour in children.
Controlled trial with permuted block design with allocation by date of referral.
Four local child and adolescent mental health services.
141 children aged 3-8 years referred with antisocial behaviour and allocated to parenting groups (90) or waiting list control (51).
Webster-Stratton basic videotape programme administered to parents of six to eight children over 13-16 weeks. This programme emphasises engagement with parental emotions, rehearsal of behavioural strategies, and parental understanding of its scientific rationale.
Main outcome measures
Semistructured parent interview and questionnaires about antisocial behaviour in children administered 5-7 months after entering trial; direct observation of parent-child interaction.
Referred children were highly antisocial (above the 97th centile on interview measure). Children in the intervention group showed a large reduction in antisocial behaviour; those in the waiting list group did not change (effect size between groups 1.06 SD (95% confidence interval 0.71 to 1.41), P<0.001). Parents in the intervention group increased the proportion of praise to ineffective commands they gave their children threefold, while control parents reduced it by a third (effect size between groups 0.76 (0.16 to 1.36), P=0.018). If the 31 children lost to follow up were included in an intention to treat analysis the effect size on antisocial behaviour was reduced by 16%.
Parenting groups effectively reduce serious antisocial behaviour in children in real life conditions. Follow up is needed to see if the children's poor prognosis is improved and criminality prevented.
What is already known on this topicChildren who persistently display a high level of antisocial behaviour are at high risk of social rejection, juvenile delinquency, and long term unemployment; the cost to society is highWhile some behaviourally based parenting programmes have been shown to be effective in university centre trials with volunteers or specially selected cases, most trials of psychological treatments for children in real life settings have shown no effectWhat this study addsAn evidence based intervention is available for use in regular clinical practice that effectively reduces antisocial behaviour in referred childrenThe intervention works well with children at risk of criminality from a combination of highly antisocial behaviour, multiple psychopathology, and social deprivation
PMCID: PMC35270  PMID: 11473908
23.  Physiotherapy Rehabilitation After Total Knee or Hip Replacement 
Executive Summary
The objective of this health technology policy analysis was to determine, where, how, and when physiotherapy services are best delivered to optimize functional outcomes for patients after they undergo primary (first-time) total hip replacement or total knee replacement, and to determine the Ontario-specific economic impact of the best delivery strategy. The objectives of the systematic review were as follows:
To determine the effectiveness of inpatient physiotherapy after discharge from an acute care hospital compared with outpatient physiotherapy delivered in either a clinic-based or home-based setting for primary total joint replacement patients
To determine the effectiveness of outpatient physiotherapy delivered by a physiotherapist in either a clinic-based or home-based setting in addition to a home exercise program compared with a home exercise program alone for primary total joint replacement patients
To determine the effectiveness of preoperative exercise for people who are scheduled to receive primary total knee or hip replacement surgery
Clinical Need
Total hip replacements and total knee replacements are among the most commonly performed surgical procedures in Ontario. Physiotherapy rehabilitation after first-time total hip or knee replacement surgery is accepted as the standard and essential treatment. The aim is to maximize a person’s functionality and independence and minimize complications such as hip dislocation (for hip replacements), wound infection, deep vein thrombosis, and pulmonary embolism.
The Therapy
The physiotherapy rehabilitation routine has 4 components: therapeutic exercise, transfer training, gait training, and instruction in the activities of daily living. Physiotherapy rehabilitation for people who have had total joint replacement surgery varies in where, how, and when it is delivered. In Ontario, after discharge from an acute care hospital, people who have had a primary total knee or hip replacement may receive inpatient or outpatient physiotherapy. Inpatient physiotherapy is delivered in a rehabilitation hospital or specialized hospital unit. Outpatient physiotherapy is done either in an outpatient clinic (clinic-based) or in the person’s home (home-based). Home-based physiotherapy may include practising an exercise program at home with or without supplemental support from a physiotherapist.
Finally, physiotherapy rehabilitation may be administered at several points after surgery, including immediately postoperatively (within the first 5 days) and in the early recovery period (within the first 3 months) after discharge. There is a growing interest in whether physiotherapy should start before surgery. A variety of practises exist, and evidence regarding the optimal pre- and post-acute course of rehabilitation to obtain the best outcomes is needed.
Review Strategy
The Medical Advisory Secretariat used its standard search strategy, which included searching the databases of Ovid MEDLINE, CINHAL, EMBASE, Cochrane Database of Systematic Reviews, and PEDro from 1995 to 2005. English-language articles including systematic reviews, randomized controlled trials (RCTs), non-RCTs, and studies with a sample size of greater than 10 patients were included. Studies had to include patients undergoing primary total hip or total knee replacement, aged 18 years of age or older, and they had to have investigated one of the following comparisons: inpatient rehabilitation versus outpatient (clinic- or home-based therapy) rehabilitation, land-based post-acute care physiotherapy delivered by a physiotherapist compared with patient self-administered exercise and a land-based exercise program before surgery. The primary outcome was postoperative physical functioning. Secondary outcomes included the patient’s assessment of therapeutic effect (overall improvement), perceived pain intensity, health services utilization, treatment side effects, and adverse events
The quality of the methods of the included studies was assessed using the criteria outlined in the Cochrane Musculoskeletal Injuries Group Quality Assessment Tool. After this, a summary of the biases threatening study validity was determined. Four methodological biases were considered: selection bias, performance bias, attrition bias, and detection bias. A meta-analysis was conducted when adequate data were available from 2 or more studies and where there was no statistical or clinical heterogeneity among studies. The GRADE system was used to summarize the overall quality of evidence.
Summary of Findings
The search yielded 422 citations; of these, 12 were included in the review including 10 primary studies (9 RCTs, 1 non-RCT) and 2 systematic reviews.
The Medical Advisory Secretariat review included 2 primary studies (N = 334) that examined the effectiveness of an inpatient physiotherapy rehabilitation program compared with an outpatient home-based physiotherapy program on functional outcomes after total knee or hip replacement surgery. One study, available only as an abstract, found no difference in functional outcome at 1 year after surgery (TKR or THR) between the treatments. The other study was an observational study that found that patients who are younger than 71 years of age on average, who do not live alone, and who do not have comorbid illnesses recover adequate function with outpatient home-based physiotherapy. However results were only measured up to 3 months after surgery, and the outcome measure they used is not considered the best one for physical functioning.
Three primary studies (N = 360) were reviewed that tested the effectiveness of outpatient home-based or clinic-based physiotherapy in addition to a self-administered home exercise program, compared with a self-administered exercise program only or in addition to using another therapy (phone calls or continuous passive movement), on postoperative physical functioning after primary TKR surgery. Two of the studies reported no difference in change from baseline in flexion range of motion between those patients receiving outpatient or home-based physiotherapy and doing a home exercise program compared with patients who did a home exercise program only with or without continuous passive movement. The other study reported no difference in the Western Ontario and McMaster Osteoarthritis Index (WOMAC) scores between patients receiving clinic-based physiotherapy and practising a home exercise program and those who received monitoring phone calls and did a home exercise program after TKR surgery.
The Medical Advisory Secretariat reviewed two systematic reviews evaluating the effects of preoperative exercise on postoperative physical functioning. One concluded that preoperative exercise is not effective in improving functional recovery or pain after TKR and any effects after THR could not be adequately determined. The other concluded that there was inconclusive evidence to determine the benefits of preoperative exercise on functional recovery after TKR. Because 2 primary studies were added to the published literature since the publication of these systematic reviews the Medical Advisory Secretariat revisited the question of effectiveness of a preoperative exercise program for patients scheduled for TKR ad THR surgery.
The Medical Advisory Secretariat also reviewed 3 primary studies (N = 184) that tested the effectiveness of preoperative exercise beginning 4-6 weeks before surgery on postoperative outcomes after primary TKR surgery. All 3 studies reported negative findings with regard to the effectiveness of preoperative exercise to improve physical functioning after TKR surgery. However, 2 failed to show an effect of the preoperative exercise program before surgery in those patients receiving preoperative exercise. The third study did not measure functional outcome immediately before surgery in the preoperative exercise treatment group; therefore the study’s authors could not document an effect of the preoperative exercise program before surgery. Regarding health services utilization, 2 of the studies did not find significant differences in either the length of the acute care hospital stay or the inpatient rehabilitation care setting between patients treated with a preoperative exercise program and those not treated. The third study did not measure health services utilization.
These results must be interpreted within the limitations and the biases of each study. Negative results do not necessarily support a lack of treatment effect but may be attributed to a type II statistical error.
Finally, the Medical Advisory Secretariat reviewed 2 primary studies (N = 136) that examined the effectiveness of preoperative exercise on postoperative functional outcomes after primary THR surgery. One study did not support the effectiveness of an exercise program beginning 8 weeks before surgery. However, results from the other did support the effectiveness of an exercise program 8 weeks before primary THR surgery on pain and functional outcomes 1 week before and 3 weeks after surgery.
Based on the evidence, the Medical Advisory Secretariat reached the following conclusions with respect to physiotherapy rehabilitation and physical functioning 1 year after primary TKR or THR surgery:
There is high-quality evidence from 1 large RCT to support the use of home-based physiotherapy instead of inpatient physiotherapy after primary THR or TKR surgery.
There is low-to-moderate quality evidence from 1 large RCT to support the conclusion that receiving a monitoring phone call from a physiotherapist and practising home exercises is comparable to receiving clinic-based physiotherapy and practising home exercises for people who have had primary TKR surgery. However, results may not be generalizable to those who have had THR surgery.
There is moderate evidence to suggest that an exercise program beginning 4 to 6 weeks before primary TKR surgery is not effective.
There is moderate evidence to support the effectiveness of an exercise program beginning 8 weeks before surgery to improve physical functioning 3 weeks after THR surgery.
PMCID: PMC3382414  PMID: 23074477
24.  Systematic review of parenting interventions in European countries aiming to reduce social inequalities in children’s health and development 
BMC Public Health  2014;14(1):1040.
Early child development influences many aspects of wellbeing, health, competence in literacy and numeracy, criminality, and social and economic participation throughout the life course. Children from disadvantaged groups have less possibilities of achieving full development. By providing a positive start for all children across the social gradient, improved developmental outcomes will be seen during later childhood and throughout their lives. The objective of this systematic review was to identify interventions during early childhood in countries from the World Health Organisation European Region in 1999–2013 which reduced inequalities in children’s health and development.
A systematic review was carried out adhering to the PRISMA guidelines. The review examined universal, targeted and proportionate universalism interventions, programs and services using an electronic search strategy in PubMed and the International Bibliography of the Social Sciences [IBSS] databases. A further search was performed in the grey literature. Interventions were included only if they were aimed at children or their parents and had been evaluated.
We identified 23 interventions in total: 6 in the PubMed data base, 5 in IBSS and 12 in grey literature. All but 1 intervention-delivered in Sweden-were carried out in the United Kingdom and the Republic of Ireland. These aimed to improve parenting abilities, however, some had additional components such as: day-care provision, improving housing conditions and speech or psychological therapies. Programmes offering intensive support, information and home visits using a psycho-educational approach and aimed at developing parent’s and children’s skills showed more favourable outcomes. These were parenting behaviours, overall children’s health and higher level of fine motor skills and cognitive functioning. Child injuries and abuse were also reduced. Two interventions were universally proportionate and all others were aimed at a specific target population.
Interventions with better outcomes and a higher level of evidence combined workshops and educational programmes for both parents and children beginning during early pregnancy and included home visits by specialised staff. Further evaluation and publication of early years interventions should be carried out also within a wider range of countries than just the UK and Ireland.
PMCID: PMC4203958  PMID: 25287010
Review; Early intervention; Parenting; Inequalities; Health; Child development
25.  Evaluation of the national roll-out of parenting programmes across England: the parenting early intervention programme (PEIP) 
BMC Public Health  2013;13:972.
Evidence based parenting programmes can improve parenting skills and the behaviour of children exhibiting, or at risk of developing, antisocial behaviour. In order to develop a public policy for delivering these programmes it is necessary not only to demonstrate their efficacy through rigorous trials but also to determine that they can be rolled out on a large scale. The aim of the present study was to evaluate the UK government funded national implementation of its Parenting Early Intervention Programme, a national roll-out of parenting programmes for parents of children 8–13 years in all 152 local authorities (LAs) across England. Building upon our study of the Pathfinder (2006–08) implemented in 18 LAs. To the best of our knowledge this is the first comparative study of a national roll-out of parenting programmes and the first study of parents of children 8–13 years.
The UK government funded English LAs to implement one or more of five evidence based programmes (later increased to eight): Triple P, Incredible Years, Strengthening Families Strengthening Communities, Families and Schools Together (FAST), and the Strengthening Families Programme (10–14). Parents completed measures of parenting style (laxness and over-reactivity), and mental well-being, and also child behaviour at three time points: pre- and post-course and again one year later.
6143 parents from 43 LAs were included in the study of whom 3325 provided post-test data and 1035 parents provided data at one-year follow up. There were significant improvements for each programme, with effect sizes (Cohen’s d) for the combined sample of 0.72 parenting laxness, 0.85 parenting over-reactivity, 0.79 parent mental well-being, and 0.45 for child conduct problems. These improvements were largely maintained one year later. All four programmes for which we had sufficient data for comparison were effective. There were generally larger effects on both parent and child measures for Triple P, but not all between programme comparisons were significant. Results for the targeted group of parents of children 8–13 years were very similar.
Evidence-based parenting programmes can be rolled out effectively in community settings on a national scale. This study also demonstrates the impact of research on shaping government policy.
PMCID: PMC4015171  PMID: 24138747
Parenting programme; Evidence based practice; Effectiveness trial; National roll-out; Triple P; Incredible years; Strengthening families strengthening communities; FAST; Strengthening families programme 10-14

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