2.1. Nocturnal Enuresis and Bedwetting2.1.1. Impact of Nocturnal Enuresis and BedwettingBedwetting is a widespread and distressing condition that can have a deep impact on the child/young person’s behavior and on their emotional and social life 1;2. It is also particularly stressful for the parents or guardians. Butler (1998) 3 has argued that the degree of parental concern and extent of child distress are important in determining the clinical significance of the problem. Bedwetting can affect normal daily routines and social activities such as sleep overs or school trips. It can also generate much more serious feelings and behaviours, such as a sense of helplessness and a lack of hope and optimism 2, feelings of being different from others, feelings of guilt and shame, humiliation, victimization and loss of self-esteem 3;4. There is evidence that children with bedwetting have higher than average levels of oppositional behaviour and conduct problems 5. While the majority of parents do not get angry with their child as a result of bedwetting, there is evidence of a link with child punishment, including physical abuse by parents/guardians 6. The correlation between nocturnal enuresis and lower self esteem seems to be a common finding 1, although the definition of self esteem varies between studies. Boys seem to rate bedwetting as more difficult than girls 7 and boys had lower self esteem scores 1. Collier (2002) 8 also reported that girls with NE had significantly higher self esteem scores compared to boys. However, Theunis (2002) 9 reported that enuretic girls had a lower perceived competence concerning their scholastic skills and social acceptance compared to the boys, but it was not clear whether this was the group with the highest percentage of daytime wetting. There was evidence that after successful treatment self esteem scores increased in both boys and girls 10. Show
2.1.2. Epidemiology of Nocturnal Enuresis and BedwettingThe epidemiology of bedwetting is complicated by the variety of definitions used in studies. The prevalence of bedwetting decreases with age. The Avon Longitudinal Study found that infrequent bedwetting (defined in their study as bedwetting less than 2 nights per week) has a prevalence of 21% at 4 years and 6 months and 8% at 9 years and 7 months of age. Nocturnal enuresis (defined in their study as bedwetting more than 2 nights per week) has a prevalence of 8% at 4 years and 6 months and 1.5% at 9 years and 7 months of age 11 An epidemiological study in Hong Kong 12 defined bedwetting as 1 wet night over a 3 month period and reported a prevalence of 16.1% at age 5years, 10.1% at 7 years and 2.2% at 19 years. The prevalence is greater for boys than girls at all ages. 2.1.3. Classification and definitions of Nocturnal Enuresis and BedwettingThe terminology used to describe both lower urinary tract symptoms and associated conditions or syndromes has been the subject of much confusion. Terms used include nocturnal enuresis, enuresis, bedwetting and incontinence of urine when sleeping. The Diagnostic & Statistical Manual of Mental Disorders (DSM- IV) defines nocturnal enuresis as an involuntary voiding of urine during sleep, with a severity of at least twice a week, in children aged >5 years in the absence of congenital or acquired defects of the central nervous system 13. Butler (2005) 13 makes a distinction between nocturnal enuresis and infrequent bedwetting. Nocturnal enuresis is defined as in the DSM-IV definition i.e. wetting at least twice a week and infrequent bedwetting as less than twice a week. This distinction is considered to have value as infrequent bedwetting is common in younger children but the prevalence falls sharply between 4 and 6 years of age, whereas children with more frequent wetting are more likely to have persisting symptoms. The International Children’s Continence Society (ICCS) have worked to standardise descriptions of lower urinary tract symptoms and conditions in children 14. Their main aim is to promote standardisation of terms and definitions used in research studies so that it is easier to compare studies and understand the population groups included. The ICCS considers that terms should be descriptive rather than express or imply underlying causes; that where possible terminology should be similar to that used when describing adult bladder function and that correct descriptive terms should not require invasive or complicated testing. The ICCS acknowledge that terms that have been used for many years and have been accepted cannot simply be discarded. The ICCS promote the use of the term incontinence when describing uncontrollable leakage of urine. Enuresis is defined as intermittent incontinence of urine when sleeping, with ‘nocturnal’ added for greater clarity if needed. The ICCS suggest using the term mono-symptommatic enuresis to signify that children have problems only when asleep; the term non-mono-symptommatic enuresis describes the symptoms of children who have urinary incontinence at night and also have daytime symptoms. Nocturnal can be included as in mono-symptomatic nocturnal enuresis (MNE) and non-mono symptommatic enuresis (NMNE). One of the important aspects in the management of lower urinary tract symptoms in children is the recognition that symptoms which may be considered normal in a younger child may be considered pathological in an older child. The DSM –IV definition of Nocturnal Enuresis uses an age of > 5 years. 2.1.4. Pathophysiology and targeting of treatmentThe causes of bedwetting are not fully understood. Bedwetting is best considered as a symptom that may result from a combination of different predisposing factors 15. There are a number of different disturbances of physiology that may be associated with the development of bedwetting. These disturbances may be categorised as:
A variety of factors are associated with bedwetting. There is frequently a strong family history of bedwetting and genetic studies have reported linkage to a number of different gene loci 16. There is an association between bedwetting, daytime urinary symptoms and daytime soiling. In the ALSPAC cohort 3.3% of children had both daytime wetting and bedwetting at 7 years and 6 months, with 2.3% having both daytime soiling and bedwetting. Daytime urgency increased with severity of bedwetting and occurred in 28.9% of children with NE (defined in the study according to DSM –IV) 13. In Attention Deficit and Hyperactivity Disorder (ADHD) there is an incidence of NE of around 10% 17. The association of bedwetting with disorders with attentional problems links with the arousal difficulties considered important in pathophysiology of bedwetting. It is a significant feature for some children with difficult to manage NE. Identifying the likely underlying mechanism for the wetting may allow better use of certain treatments. Unfortunately the clinical features do not often lead to a clear differentiation of underlying pathological mechanisms The quality of much of the clinical research is poor with low numbers and inadequate description of symptoms in the study populations. To date the studies are not adequate to assess the treatment hypotheses generated from current physiological understanding. Current understanding of pathophysiology suggests that a history of bedwetting without daytime symptoms makes polyuria more likely and these children may respond better to desmopressin than those who have bladder disturbances 15. Children with bladder difficulties, either overactive bladder or small bladder capacity respond less well to desmopressin 18;19. Some will have daytime symptoms (urinary urgency, frequency, wetting, urge incontinence hesitancy, poor urinary stream, abdominal straining) but others have an isolated night time disorder 20. Nocturnal polyuria may be diagnosed using overnight nappy weights and history, fluid intake / bladder diaries will identify most children with bladder dysfunction although some children will need detailed urodynamics. The ICCS 14 now recommends that all research studies properly define their patients by screening for daytime symptoms and measurement of overnight urine production. This is thought to be particularly important when evaluating drugs that treat polyuria (e.g desmopressin) and drugs for overactive bladder (e.g anticholinergics). Historically this has not been done although many studies have identified the presence or absence of daytime wetting (one symptom of bladder dysfunction). 2.2. Approach of this GuidelineThis guideline aims to provide advice on the assessment and management of children and young people with bedwetting. The guidance is applicable to children and young people up to 19 years with the symptom of bedwetting. It has been common practice to define enuresis as abnormal from 5 years and only to consider children for treatment when they are 7 years. While the prevalence of symptoms decreases with age the guideline scope did not specify a younger age limit in order to consider whether there were useful interventions that might be of benefit to children previously excluded from advice and services. For the purposes of this guideline we have used the terms ‘bedwetting’, and ‘daytime symptoms’ to describe those symptoms that may be experienced by the population who present for treatment for ‘bedwetting’. This terminology is used for clarity and as it is an accurate representation of the populations included in the research evidence. While the ICCS now recommends that all children included in studies have their night and daytime symptoms properly recorded, this has been a recent development. Research evidence clearly defining children as mono-symptomatic or non-mono-symptomatic is not available for most of the potential interventions. Some studies explicitly state that they excluded children with daytime wetting. We classified these as studies where the population had bedwetting or nighttime wetting only. We acknowledge that some of these children may have had daytime symptoms other than wetting such as urgency or frequency. The remainder of studies did not report either including or excluding daytime wetting or symptoms and we considered them as studies where the population had bedwetting with possible daytime symptoms. The evidence is therefore reported as follows:
The presence or absence of daytime symptoms can be helpful for understanding the underlying problem and possibly for planning treatment but the assessement and management of daytime symptoms is not within the scope of this guideline. The evidence for these different subgroups was looked at separately. However, as no significant differences were found as to warrant differential treatment, the recommendations are based on data from all subgroups. 2.3. RemitThe following remit was received from the Department of Health:
2.4. What is a guideline?NICE clinical guidelines provide recommendations for the care of individuals in specific clinical conditions or circumstances within the NHS – from prevention and self-care through primary and secondary care to more specialised services. We base our clinical guidelines on the best available research evidence, with the aim of improving the quality of health care. We use predetermined and systematic methods to identify and evaluate the evidence relating to specific clinical questions. While guidelines assist the practice of healthcare professionals, they do not replace their knowledge and skills. Clinical guidelines can:
The NCGC and NICE produce a number of versions of this guideline:
This version is the full version. The other versions can be downloaded from NICE www.NICE.org.uk. 2.5. What the guideline coversThe guideline was developed in line with the guideline scope. Prior to the commencement of the guideline the scope was subject to stakeholder consultation in accordance with processes established by NICE in the guideline manual. The scope is included in Appendix A and summarized below. 2.5.1. Groups
An upper age of 19 is used to as the guideline includes young people with and without special needs. Educational and social services commonly continue for children with special needs up to 19 years. The age range used was agreed with NICE following stakeholder comments on the scope.
2.5.2. Clinical managementThe aspects of clinical management included are:
2.6. What the guideline does not cover2.6.1. Groups
2.7. Guideline LimitationsGuideline limitations are as follows:
2.8. Who developed this guideline?2.8.1. The National Collaborating Centre for Primary Care/National Clinical Guidelines CentreThis guideline was commissioned by NICE from the National Collaborating Centre for Primary Care (NCC-PC). On 1st April 2009 the NCC-PC merged with 3 other collaborating centres to form the National Clinical Guidelines Centre (NCGC). The development of this guideline was therefore started at the NCC-PC and completed at the NCGC. The NCGC is one of four centres funded by NICE and comprises a partnership between a variety of academic, professional and patient-based organisations. As a multidisciplinary centre we draw upon the expertise of the healthcare professions and academics and ensure the involvement of patients in our work. 2.8.2. The development teamThe development team had the responsibility for this guideline throughout its development. They were responsible for preparing information for the Guideline Development Group (GDG), for drafting the guideline and for responding to consultation comments. The development team working on this guideline consisted of the:
2.8.3. The Guideline Development Group (GDG)A Chair was chosen for the group and his primary role was to facilitate and chair the GDG meetings. The GDG consisted of a diverse multidisciplinary group with an interest and/or expertise in Nocturnal Enuresis. The Chair who oversaw the work, Dr Jonathan Evans, works as a NHS Consultant Paediatric Nephrologist at The Children and Young Peoples Kidney Unit Nottingham University Hospitals. Dr Evans chairs the British Association for Paediatric Nephrology Registry Group and is a member of the Royal College of Paediatrics and Child Health Quality of Practice Committee. Dr Evans has co-authored seven Cochrane Systematic Reviews, has developed many clinical guidelines locally and was a member of the NICE guideline development group for Anaemia Management in Chronic Kidney Disease. The professional representatives on the Group were chosen according to a set process. The NCCPC project team decided on the necessary professional representation required for the GDG, based on the scope of the guideline. Professional registered stakeholder organisations were written to notify them of the advertisement and recruitment process. Once all of the applications were received, the NCC-PC Chief Executive, Chair and the Guideline Lead selected the individual members, on the basis of their CV’s, supporting statements, and against a selection criteria adapted from the person specification and job description. For the patient members, the PPIP at NICE submitted the received applications, from which the Chair and the Guideline Lead chose two as patient members based on the aim (as with the professional healthcare applicants) of including as wide a range as possible of expertise, experience, and professional and geographic representation from across England and Wales. Applicants who were not selected for the GDG were invited to act as Expert Peer Reviewers and were sent drafts of the guideline by the Institute during the consultation periods and invited to submit comments using the same process as stakeholders. In accordance with guidance from NICE, all GDG members’ and the Chair declared in writing interests that covered consultancies, fee-paid work, share-holdings, fellowships, and support from the healthcare industry and these were made available in the public domain. Details of these can be seen in Appendix E. Declaration of interests were updated at the start of each GDG meeting. A record of updated declarations of interest was recorded in the NCGC’s database and the minutes of each meeting were produced. The minutes of the GDG meetings were published on the NICE website within 2 weeks of being agreed by the GDG. The Chair and each GDG member received a copy of The Guidelines Manual (January 2009) once this was updated. The names of GDG members appear listed below. Full GDG membersDr Jonathan Evans (Chair) Consultant Paediatric Nephrologist Nottingham Children’s Hospital, Nottingham University Hospitals NHS Trust Dr Anne Wright Consultant Paediatrician, Children’s Bladder Clinic Evelina Children’s Hospital, Guy’s and St. Thomas’ Foundation NHS Trust Mrs Charlotte Mawby Senior Clinical Specialist Nurse Advisor in Paediatric Continence Community Health Oxfordshire, Hosted by Oxfordshire Primary Care Trust Jubilee House Mrs Deborah Chippington-Derrick Parent and Carer Member Company Director/Software Engineer Mrs Janet Wootton Specialist Enuresis Nurse School Health Nurse York Hospital NHS Foundation trust Dr Patricia Hall Chartered Clinical Psychologist Sheffield Children’s NHS Foundation Trust Dr Penelope Dobson MBE Patient Member Founder and former director of the children’s charity ERIC (Education and Resources for Improving Childhood Continence) and currently chair of the Paediatric Continence Forum (PCF) Mrs Philippa Williams Parent and Carer member Project Worker Dr Mark Mac Kenzie General Practitioner Albany House Medical Centre Mrs Sally Norfolk Operational Lead School Nursing, Children and Family Services. NHS Leeds Community Healthcare Dr Ursula Butler Consultant Community Paediatrician Clinical Lead Community Continence Service, Sheffield Children’s NHS Foundation Trust Co-opted ExpertsMrs Anne Longton Clinical Lead Health Visiting (East Sussex Downs and Weald PCT) NCGC-ACC staffDr Norma O’Flynn Guideline Lead and Clinical Director Ms Vanessa Nunes Senior Health Services Research Fellow and Project Manager Ms Laura Sawyer Senior Health Economist Ms Katrina Sparrow Senior Health Services Research Fellow 2.8.4. Guideline Development Group meetingsThe GDG met on eleven occasions at approximately 6 weekly intervals over a period of fifteen months to review the evidence identified by the project team, to comment on its quality and completeness and to develop recommendations for clinical practice based on the available evidence. The final recommendations were agreed by the full GDG. 2.9. Research recommendationsThe Guideline Development Group has made the following recommendations for research, based on its review of evidence, to improve NICE guidance and patient care in the future. 2.9.1. What elements of multi-component treatments, for example dry bed training and retention control training, are clinically effective and cost effective for treating bedwetting in children and young people under 19 years old?Why this is importantThe elements of multi-component treatments, for example dry bed training and retention control training, that are clinically effective and cost effective for treating bedwetting in children and young people under 19 years old is not known. Data from randomised controlled trials of dry bed training and retention control training suggest that the treatments may be clinically effective. However, certain elements of the multicomponent treatments are not acceptable as a form of treatment due to their punitive nature. It is not known which elements of the treatments are effective and therefore could be used in the treatment of nocturnal enuresis. Research should:
Outcomes of interest include: the number of children who achieved 14 consecutive dry nights, the number of children who remain dry at 6 months and 2 years after treatment, the mean number of wet nights after treatment, the change in the number of wet nights, the psychological effect of treatment, psychological effects (self-esteem, self-concept, PinQ 21 ), quality of life measures and drop outs. 2.9.2. What is the clinical and cost effectiveness of standard interventions e.g. alarm and desmopressin for treating bedwetting in children and young people under 19 years old?Why this is importantThe evidence base for management of bedwetting is poor. Studies are inadequately powered, symptoms are poorly defined and study populations are commonly children seen in secondary and tertiary centres. Follow up periods are often inadequate. Research should:
2.9.3. What is the clinical and cost effectiveness of desmopressin versus combination desmopressin plus night time only tolterodine/oxybutynin in children with non-monosymptomatic nocturnal enuresis?Why this is importantChildren with non-monosymptomatic nocturnal enuresis (NME) are estimated to make up one third of the population of children with enuresis and are considered more resistant to treatment than monosymptomatic enuresis. The combination of an anticholinergic agent and desmopressin at night time for this group should theoretically work to stabilise the bladder and increase bladder capacity in addition to decreasing nocturnal urinary production. One previous trial found that the combination of oxybutynin and desmopressin in a group of children with NME was significantly more effective versus desmopressin after one month of treatment but not at six months of treatment. Further studies are needed to corroborate this study both using night time only oxybutynin or longer-acting night time only tolterodine combined with desmopressin versus desmopressin alone in the NME group of children. Research should: Use a double-blind randomised control trial of medication (as above) in children with NME Research outcomes should include
2.9.4. What is the impact of bedwetting upon the psychological functioning and quality of life of children and their families? How do these change with treatment?Why this is importantThere are relatively few studies which focus upon the psychological impact and health-related quality of life of children who experience bedwetting. In addition, studies of effectiveness have focused on the achievement of dryness as the primary outcome rather than how treatment might affect social and psychological aspects as well as the quality of life of children and young people and their families. Research should:
Quality of life research of children with bedwetting pre and post treatment would also be very useful in informing further economic evaluation work in the area. 2.9.5. What is the effectiveness of psychological therapies in the treatment of bedwetting? Which psychological therapy is most useful? For which clinical groups would psychological therapies be the most appropriate intervention?Why this is importantThere is some evidence that CBT may be useful as a treatment in children with severe bed-wetting, however, there are few robust studies that examine the effectiveness of CBT for other clinical groups or psychological therapies more widely as treatment for bed-wetting. Research should:
2.9.6. What is the effectiveness of complementary therapies (acupuncture and hypnotherapy) for reducing the number of wet beds and improving self esteem in children who wet the bed when they are used independently or in conjunction with conventional treatments?Why this is importantMany families consider the use of complementary and or alternative medicine (CAM) as a treatment options when conventional treatment ‘fails’ or in order to avoid drug or other treatments. There is very little evidence about the efficacy of many complementary and alternative treatments but the use of CAM is widespread and increasing across the developed world. There is a clear need for more effective guidance for the public and health professionals who advise patients as to what does and does not work and what is and is not safe. Research should:
2.9.7. What is the prevalence of wetting/soiling in adolescence and what are the long term consequences for adolescents with these problems?Why this is importantThere is evidence that, for an important minority of children, wetting and soiling problems persist into late childhood and sometimes beyond puberty, but their prevalence is not clearly known. It has also recently been reported that children who experience more frequent bedwetting (more than three times a week) are more likely to persist with the problem into late childhood and adolescence. These studies suggest that, contrary to popular belief, wetting and soiling problems do not always resolve with increasing age. If wetting/soiling problems remain unresolved or untreated they can become socially and psychologically debilitating. There are no longitudinal cohort studies examining the impact of wetting and soiling on a wide range of outcomes in adolescence relating to mental health, education/school attainment, relationships with parents and peers, social activities and goals/aspirations for the future. Persistence of wetting/soiling problems into this phase is likely to be accompanied by ridicule and bullying by peers and increasing intolerance from parents, especially if they believe that their child is to blame for the problem. Such reactions can only serve to exacerbate the young person’s distress and may lead to delays in seeking help. In particular, teenagers who are unsuccessfully treated in childhood are often reluctant to seek help for wetting or soiling due to the severe embarrassment associated with the problem, and others may simply believe that no help is available. Research should:
Outcomes of interest include: the examination of mental health, psychosocial and educational outcomes and whether adolescents who have combined wetting and soiling are at increased risk of negative outcomes compared to those with wetting or soiling alone. 2.10. AcknowledgementsWe gratefully acknowledge the contributions of the following people: Ms Julie Neilson, Dr Grammati Sari, Ms Sarah Willett, Mr Andrew Gyton, Ms Sarah Willis, Dr Alec Miners, Dr David Wonderling, Dr Ipek Akil, Mr Carlos Sharpin, Ms Joanna Ashe, Mrs Karen Head, and Mrs Liz Avital. 2.11. GlossaryAbsolute risk reduction(Risk difference) The difference in the risk of an event between two groups (one subtracted from the other) in a comparative study. AbstractSummary of a study, which may be published alone or as an introduction to a full scientific paper. AdherenceThe extent to which the patient’s behaviour matches the prescriber’s recommendations. Adherence emphasises the need for agreement and that the patient is free to decide whether or not to adhere to the doctor’s recommendation. AdjustmentA statistical procedure in which the effects of differences in composition of the populations being compared (or treatment given at the same time) have been minimised by statistical methods. AlarmSee ‘Enuresis alarm’. Algorithm (in guidelines)A flow chart of the clinical decision pathway described in the guideline, where decision points are represented with boxes, linked with arrows. Allocation concealmentThe process used to prevent advance knowledge of group assignment in a RCT. The allocation process should be impervious to any influence by the individual making the allocation, by being administered by someone who is not responsible for recruiting participants. ApplicabilityThe degree to which the results of an observation, study or review are likely to hold true in a particular clinical practice setting. Arm (of a clinical study)Sub-section of individuals within a study who receive one particular intervention, for example placebo arm. AssociationStatistical relationship between two or more events, characteristics or other variables. The relationship may or may not be causal. AuditSee ‘Clinical audit’. BaselineThe initial set of measurements at the beginning of a study (after run-in period where applicable), with which subsequent results are compared. BiasSystematic (as opposed to random) deviation of the results of a study from the ‘true’ results that is caused by the way the study is designed or conducted. Bladder diaryA diary that records voiding times and voided volumes, leakage episodes, pad usage and other information such as fluid intake, degree of urgency, and degree of incontinence. See also ‘Frequency-volume chart’. Bladder trainingBladder training (also described as bladder retraining, bladder drill, bladder re-education, bladder discipline) actively involves the individual in attempting to increase the interval between the desire to void and actual void. BedwettingTerm used in this guideline to describe discrete urinary incontinence occurring during sleep; synonymous with enuresis and with nocturnal urinary incontinence Blinding(Masking) Keeping the study participants, caregivers, researchers and outcome assessors unaware about the interventions to which the participants have been allocated in a study. Capital costsCosts of purchasing major capital assets (usually land, buildings or equipment). Capital costs represent investments at one point in time. Carer (caregiver)Someone other than a health professional who is involved in caring for a person with a medical condition. Case-control studyComparative observational study in which the investigator selects individuals who have experienced an event (for example, developed a disease) and others who have not (controls), and then collects data to determine previous exposure to a possible cause. Case seriesReport of a number of cases of a given disease, usually covering the course of the disease and the response to treatment. There is no comparison (control) group of patients. CCASee ‘Cost-consequences analysis‘. CCTSee ‘Controlled clinical trial‘. CEASee ‘Cost-effectiveness analysis‘. ChartsSee ‘Frequency-volume charts’. See ‘Confidence interval‘. Clinical auditA quality improvement process that seeks to improve patient care and outcomes through systematic review of care against explicit criteria and the implementation of change. Clinical efficacyThe extent to which an intervention is active when studied under controlled research conditions. Clinical effectivenessThe extent to which an intervention produces an overall health benefit in routine clinical practice. Clinical impactThe effect that a guideline recommendation is likely to have on the treatment or treatment outcomes, of the target population. Clinical questionIn guideline development, this term refers to the questions about treatment and care that are formulated to guide the development of evidence-based recommendations. ClusterA closely grouped series of events or cases of a disease or other related health phenomena with well-defined distribution patterns, in relation to time or place or both. Alternatively, a grouped unit for randomisation. Cochrane ReviewA systematic review of the evidence from randomised controlled trials relating to a particular health problem or healthcare intervention, produced by the Cochrane Collaboration. Available electronically as part of the Cochrane Library. Cohort studyA retrospective or prospective follow-up study. Groups of individuals to be followed up are defined on the basis of presence or absence of exposure to a suspected risk factor or intervention. A cohort study can be comparative, in which case two or more groups are selected on the basis of differences in their exposure to the agent of interest. Co-morbidityCo-existence of more than one disease or an additional disease (other than that being studied or treated) in an individual. ComparabilitySimilarity of the groups in characteristics likely to affect the study results (such as health status or age). Confidence intervalA range of values for an unknown population parameter with a stated ‘confidence’ (conventionally 95%) that it contains the true value. The interval is calculated from sample data, and generally straddles the sample estimate. The ‘confidence’ value means that if the method used to calculate the interval is repeated many times, then that proportion of intervals will actually contain the true value. ConfoundingIn a study, confounding occurs when the effect of an intervention on an outcome is distorted as a result of an association between the population or intervention or outcome and another factor (the ‘confounding variable’) that can influence the outcome independently of the intervention under study. Consensus methodsTechniques that aim to reach an agreement on a particular issue. Formal consensus methods include Delphi and nominal group techniques, and consensus development conferences. In the development of clinical guidelines, consensus methods may be used where there is a lack of strong research evidence on a particular topic. Expert consensus methods will aim to reach agreement between experts in a particular field. Control groupA group of patients recruited into a study that receives no treatment, a treatment of known effect, or a placebo (dummy treatment) - in order to provide a comparison for a group receiving an experimental treatment, such as a new drug. Controlled clinical trialA study testing a specific drug or other treatment involving two (or more) groups of patients with the same disease. One (the experimental group) receives the treatment that is being tested, and the other (the comparison or control group) receives an alternative treatment, a placebo (dummy treatment) or no treatment. The two groups are followed up to compare differences in outcomes to see how effective the experimental treatment was. A CCT where patients are randomly allocated to treatment and comparison groups is called a randomised controlled trial. Cost benefit analysisA type of economic evaluation where both costs and benefits of healthcare treatment are measured in the same monetary units. If benefits exceed costs, the evaluation would recommend providing the treatment. Cost-consequences analysisA type of economic evaluation where various health outcomes are reported in addition to cost for each intervention, but there is no overall measure of health gain. Cost-effectiveness analysisAn economic study design in which consequences of different interventions are measured using a single outcome, usually in ‘natural’ units (For example, life-years gained, deaths avoided, heart attacks avoided, cases detected). Alternative interventions are then compared in terms of cost per unit of effectiveness. Cost-effectiveness modelAn explicit mathematical framework, which is used to represent clinical decision problems and incorporate evidence from a variety of sources in order to estimate the costs and health outcomes. Cost-utility analysisA form of cost-effectiveness analysis in which the units of effectiveness are quality-adjusted life-years (QALYs). Credible intervalThe Bayesian equivalent of a confidence interval. CUASee ‘Cost-utility analysis‘. Daytime frequencyThe number of voids recorded during waking hours and includes the last void before sleep and the first void after waking and rising in the morning. Daytime symptomsRefers to the presence of lower urinary symptoms which include urinary urgency, frequency, poor urinary stream, the need for abdominal straining to void and urinary incontinence Decision analysisAn explicit quantitative approach to decision making under uncertainty, based on evidence from research. This evidence is translated into probabilities, and then into diagrams or decision trees which direct the clinician through a succession of possible scenarios, actions and outcomes. Decision problemA clear specification of the interventions, patient populations and outcome measures and perspective adopted in an evaluation, with an explicit justification, relating these to the decision which the analysis is to inform. DiscountingCosts and perhaps benefits incurred today have a higher value than costs and benefits occurring in the future. Discounting health benefits reflects individual preference for benefits to be experienced in the present rather than the future. Discounting costs reflects individual preference for costs to be experienced in the future rather than the present. DominanceAn intervention is said to be dominated if there is an alternative intervention that is both less costly and more effective. DosageThe prescribed amount of a drug to be taken, including the size and timing of the doses. Double blind/masked studyA study in which neither the subject (patient) nor the observer (investigator/clinician) is aware of which treatment nor intervention the subject is receiving. The purpose of blinding/masking is to protect against bias. Drop-outA participant who withdraws from a clinical trial before the end. Dry bed trainingA training programme that combines a number of different behavioural interventions that may include rewards, punishment training routines and waking routines and be undertaken withy or without an enuresis alarm. Economic evaluationComparative analysis of alternative health strategies (interventions or programmes) in terms of both their costs and consequences. Effect (as in effect measure, treatment effect, estimate of effect)The observed association between interventions and outcomes or a statistic to summarise the strength of the observed association. Effect sizeThis term is usually used in meta-analysis to denote treatment effect, or estimate of effect. It also refers to standardised mean difference (SMD), obtained by dividing the mean difference with the pooled standard deviation. This is the meaning usually referred to in GRADE. EffectivenessSee ‘Clinical effectiveness’. EfficacySee ‘Clinical efficacy’. EnuresisIntermittent incontinence in discrete episodes when asleep; see ‘Bedwetting’; see ‘Nocturnal enuresis’. Enuresis alarmA battery powered alarm that is triggered by urine coming into contact with the alarm sensor. Alarms come in 2 main groups: bed alarms where the sensor pad is placed under a draw sheet and body worn alarms where the sensor is placed e.g. between two pairs of snugly fitting underpants. The alarms can generate various noises or sometimes pre recorded sounds. Some body worn alarms can be set to vibration with or without sound. Epidemiological studyThe study of a disease within a population, defining its incidence and prevalence and examining the roles of external influences (for example, infection, diet) and interventions. EquityFair distribution of resources or benefits. EvidenceInformation on which a decision or guidance is based. Evidence is obtained from a range of sources including randomised controlled trials, observational studies, expert opinion (of clinical professionals and/or patients). Evidence tableA table summarising the results of a collection of studies which, taken together, represent the evidence supporting a particular recommendation or series of recommendations in a guideline. Exclusion criteria (literature review)Explicit standards used to decide which studies should be excluded from consideration as potential sources of evidence. Exclusion criteria (clinical study)Criteria that define who is not eligible to participate in a clinical study. Expert consensusSee ‘Consensus methods’. ExtrapolationIn data analysis, predicting the value of a parameter outside the range of observed values. Follow upObservation over a period of time of an individual, group or initially defined population whose appropriate characteristics have been assessed in order to observe changes in health status or health-related variables. Frequency-volume chartsPreferred term of the International Children’s Continence Society (ICCS) for charts to be completed by child and parents/carers to record urinary symptoms during treatment. GeneralisabilityThe extent to which the results of a study based on measurement in a particular patient population and/or a specific context hold true for another population and/or in a different context. In this instance, this is the degree to which the guideline recommendation is applicable across both geographical and contextual settings. For instance, guidelines that suggest substituting one form of labour for another should acknowledge that these costs might vary across the country. Gold standardSee ‘Reference standard’. Goodness-of-fitHow well a statistical model or distribution compares with the observed data. GRADESee Grading of Recommendations Assessment, Development and Evaluation. Grading of Recommendations Assessment, Development and EvaluationA systematic and explicit approach to grading the quality of evidence and the strength of recommendations. Grey literatureReports that are unpublished or have limited distribution, and are not included in the common bibliographic retrieval systems. Guideline Development GroupThe GDG agrees the review questions, considers the evidence and develops the recommendations. Membership of the GDG therefore needs to be multidisciplinary, comprising:
Adverse effects of an intervention. Health economicsThe study of the allocation of scarce resources among alternative healthcare treatments. Health economists are concerned with both increasing the average level of health in the population and improving the distribution of health. Health-related quality of lifeA combination of an individual’s physical, mental and social well-being; not merely the absence of disease. HeterogeneityOr lack of homogeneity. The term is used in meta-analyses and systematic reviews when the results or estimates of effects of treatment from separate studies seem to be very different – in terms of the size of treatment effects or even to the extent that some indicate beneficial and others suggest adverse treatment effects. Such results may occur as a result of differences between studies in terms of the patient populations, outcome measures, definition of variables or duration of follow-up. HomogeneityThis means that the results of studies included in a systematic review or meta-analysis are similar and there is no evidence of heterogeneity. Results are usually regarded as homogeneous when differences between studies could reasonably be expected to occur by chance. ICERSee ‘Incremental cost effectiveness ratio‘. ImprecisionImprecision is one of the quality elements considered under the GRADE system. Results are imprecise when studies include relatively few patients and few events and thus have wide confidence intervals around the estimate of the effect. Inclusion criteria (literature review)Explicit criteria used to decide which studies should be considered as potential sources of evidence. Incremental analysisThe analysis of additional costs and additional clinical outcomes with different interventions. Incremental costThe mean cost per patient associated with an intervention minus the mean cost per patient associated with a comparator intervention. Incremental cost effectiveness ratioThe difference in the mean costs in the population of interest divided by the differences in the mean outcomes in the population of interest for one treatment compared with another. ICER=(CostA-CostB)/( EffectivenessA-EffectivenessB). InconsistencyInconsistency is one of the elements of quality considered under the GRADE system. Inconsistency refers to the unexplained heterogeneity in the results observed. IndirectnessIndirectness is one of the elements of quality considered under the GRADE system. Indirectness of evidence refers to the difference in study population, intervention, comparator and outcomes between the available evidenced and the clinical question or population addressed in the guideline recommendations. Indication (specific)The defined use of a technology as licensed by the Medicines and Healthcare products Regulatory Agency (MHRA). Intention-to-treat analysisAn analysis of the results of a clinical study in which the data are analysed for all study participants as if they had remained in the group to which they were randomised, regardless of whether or not they remained in the study until the end, crossed over to another treatment or received an alternative intervention. Intermediate outcomesOutcomes that are related to the outcome of interest but may be more easily assessed within the context of a clinical study. Internal validityThe degree to which the results of a study are likely to approximate the ‘truth’ for the participants recruited in a study (that is, are the results free of bias?). It refers to the integrity of the design and is a prerequisite for applicability (external validity) of a study’s findings. See ‘External validity’. InterventionHealthcare action intended to benefit the patient, for example, drug treatment, surgical procedure, psychological therapy. ITT analysisSee ‘Intention-to-treat analysis‘. LicenceSee ‘Product licence’. Mean average years of life gained per person as a result of the intervention compared with an alternative intervention. LiftingLifting is carrying or walking a child to toilet. Lifting without waking means that effort is not made to ensure the child is fully woken. Likelihood ratioThe ratio of the probability that a person with a condition has a specified test result to the probability that a person without the condition has the same specified test result. For positive test results, this is referred to as ‘Likelihood ratio positive’, LR+. For negative test result, this is known as ‘Likelihood ratio negative’, LR −. Literature reviewAn article that summarises the evidence contained in a number of different individual studies and draws conclusions about their findings. It may or may not be systematically researched and developed. LRSee ‘Likelihood ratio‘. Markov modelA method for estimating long term costs and effects for recurrent or chronic conditions, based on health states and the probability of transition between them within a given time period (cycle). Medical devicesAll products, except medicines, used in healthcare for the diagnosis, prevention, monitoring or treatment of illness or handicap. Meta-analysisA statistical technique for combining (pooling) the results of a number of studies that address the same question and report on the same outcomes to produce a summary result. The aim is to derive more precise and clear information from a large data pool. It is generally more reliably likely to confirm or refute a hypothesis than the individual trials. MIDSee ‘Minimal important difference‘. Minimal important differenceThis is the smallest change which can be recognised by a patient as being clinically significant. Monossymptomatic nocturnal enuresisNocturnal enuresis without any daytime urinary symptoms (see daytime symptoms). Multivariate modelA statistical model for analysis of the relationship between two or more predictor (independent) variables and the outcome (dependent) variable. Narrative summarySummary of findings given as a written description. Network Meta-analysisType of analysis that allows for the synthesis of data from direct and indirect comparisons and allows for the ranking of different interventions in order of efficacy. National Clinical Guideline CentreCentre commissioned by NICE to develop the nocturnal enuresis guideline. NCGCSee ‘National Clinical Guideline Centre‘. NMASee ‘Network Meta-analysis‘. NNTSee ‘Number needed to treat‘. Nocturnal enuresisEnuresis is intermittent incontinence in discrete episodes when asleep; the term nocturnal is often used for clarity. Non-monossymptomatic nocturnal enuresisNocturnal enuresis with associated daytime urinary symptoms Nocturnal polyuriaNocturnal urine output exceeding 130% of expected bladder capacity. Number needed to treatThe number of patients that who on average must be treated to prevent a single occurrence of the outcome of interest. Observational studyRetrospective or prospective study in which the investigator observes the natural course of events with or without control groups; for example, cohort studies and case–control studies. Odds ratioA measure of treatment effectiveness. The odds of an event happening in the treatment group, expressed as a proportion of the odds of it happening in the control group. The ‘odds’ is the ratio of events to non-events. Off-labelA drug or device used treat a condition or disease for which it is not specifically licensed. Opportunity costThe opportunity cost of investing in a healthcare intervention is the loss of other healthcare programmes that are displaced by its introduction. This may be best measured by the health benefits that could have been achieved had the money been spent on the next best alternative healthcare intervention. Overactive bladderBladder condition where main symptom is urgency and symptoms may include have frequency and wetting. OutcomeMeasure of the possible results that may stem from exposure to a preventive or therapeutic intervention. Outcome measures may be intermediate endpoints or they can be final endpoints. See ‘Intermediate outcome’. Partial responsePartial response is 50% reduction in wet nights; or a response less than 14 dry nights or 90% improvement in bedwetting. PinQA continence-specific paediatric quality-of-life measurement tool. P valueThe probability that an observed difference could have occurred by chance, assuming that there is in fact no underlying difference between the means of the observations. If the probability is less than 1 in 20, the P value is less than 0.05; a result with a P value of less than 0.05 is conventionally considered to be ‘statistically significant’. PolysymptommaticSee ‘Non-monosymptomatic nocturnal enuresis’. PolyuriaSee ‘Nocturnal polyuria’. PlaceboAn inactive and physically identical medication or procedure used as a comparator in controlled clinical trials. Placebo effectA beneficial (or adverse) effect produced by a placebo and not due to any property of the placebo itself. Primary careDescribes services that patients have access to without requiring referral from another health care professional. Primary care is usually delivered outside hospitals and primary care includes GPs, dentists, pharmacists and opticians. Primary researchStudy generating original data rather than analysing data from existing studies (which is called secondary research). Product licenceAn authorisation from the MHRA to market a medicinal product. A drug may be ‘licensed ’ for several conditions. When a drug is referred to as ‘unlicensed’ for a particular indication, that means it may have a marketing authorisation for other conditions, but not for the condition discussed. This is also known as ‘off label’ use. Prospective studyA study in which people are entered into the research and then followed up over a period of time with future events recorded as they happen. This contrasts with studies that are retrospective. QALYSee ‘Quality-adjusted life year‘. Quality of lifeSee ‘Health-related quality of life’. Quality-adjusted life yearAn index of survival that is adjusted to account for the patient’s quality of life during this time. QALYs have the advantage of incorporating changes in both quantity (longevity/mortality) and quality (morbidity, psychological, functional, social and other factors) of life. Used to measure benefits in cost-utility analysis. The QALYs gained are the mean QALYs associated with one treatment minus the mean QALYs associated with an alternative treatment. Quick Reference GuideAn abridged version of NICE guidance, which presents the key priorities for implementation and summarises the recommendations for the core clinical audience. RandomisationAllocation of participants in a research study to two or more alternative groups using a chance procedure, such as computer-generated random numbers. This approach is used in an attempt to ensure there is an even distribution of participants with different characteristics between groups and thus reduce sources of bias. Randomised controlled trialA comparative study in which participants are randomly allocated to intervention and control groups and followed up to examine differences in outcomes between the groups. RCTSee ‘Randomised controlled trial’. Relative riskThe number of times more likely or less likely an event is to happen in one group compared with another (calculated as the risk of the event in group A/the risk of the event in group B). RemitThe brief given by the Department of Health and Welsh Assembly Government at the beginning of the guideline development process. This defines core areas of care that the guideline needs to address. Recurrence of bedwettingDescribes children who have responded to treatment but bedwetting recurs when active treatment stops. Resource implicationThe likely impact in terms of finance, workforce or other NHS resources. Response to treatmentResponse to treatment was measured by attainment of 14 dry nights or 90% reduction in wet nights. Retention control trainingTraining routines to improve the ability to defer the need to pass urine. Retrospective studyA retrospective study deals with the present/past and does not involve studying future events. This contrasts with studies that are prospective. Review of the literatureAn article that summarises the evidence contained in a number of different individual studies and draws conclusions about their findings. It may or may not be systematically researched and developed. RRSee ‘Relative risk‘. SASee ‘Sensitivity analysis‘. Secondary bedwettingBedwetting that has occurred after a child has been dry at night for more than 6 months. Secondary benefitsBenefits resulting from a treatment in addition to the primary, intended outcome. Selection bias (also allocation bias)A systematic bias in selecting participants for study groups, so that the groups have differences in prognosis and/or therapeutic sensitivities at baseline. Randomisation (with concealed allocation) of patients protects against this bias. Selection criteriaExplicit standards used by guideline development groups to decide which studies should be included and excluded from consideration as potential sources of evidence. SensitivitySensitivity or recall rate is the proportion of true positives which are correctly identified as such. For example in diagnostic testing it is the proportion of true cases that the test detects. See the related term ‘Specificity’. Sensitivity analysisA means of representing uncertainty in the results of economic evaluations. Uncertainty may arise from missing data, imprecise estimates or methodological controversy. Sensitivity analysis also allows for exploring the generalisability of results to other settings. The analysis is repeated using different assumptions to examine the effect on the results. One-way simple sensitivity analysis (univariate analysis): each parameter is varied individually in order to isolate the consequences of each parameter on the results of the study. Multi-way simple sensitivity analysis (scenario analysis): two or more parameters are varied at the same time and the overall effect on the results is evaluated. Threshold sensitivity analysis: the critical value of parameters above or below which the conclusions of the study will change are identified. Probabilistic sensitivity analysis: probability distributions are assigned to the uncertain parameters and are incorporated into evaluation models based on decision analytical techniques (For example, Monte Carlo simulation). Severe WettingBedwetting that occurs more than five times a week. StakeholderThose with an interest in the use of the guideline. Stakeholders include manufacturers, sponsors, healthcare professionals, and patient and carer groups. Statistical powerThe ability to demonstrate an association when one exists. Power is related to sample size; the larger the sample size, the greater the power and the lower the risk that a possible association could be missed. Synthesis of evidenceA generic term to describe methods used for summarising (comparing and contrasting) evidence into a clinically meaningful conclusion in order to answer a defined clinical question. This can include systematic review (with or without meta-analysis), qualitative and narrative summaries. Systematic reviewResearch that summarises the evidence on a clearly formulated question according to a pre-defined protocol using systematic and explicit methods to identify, select and appraise relevant studies, and to extract, collate and report their findings. It may or may not use statistical meta-analysis. Time horizonThe time span used in the NICE appraisal which reflects the period over which the main differences between interventions in health effects and use of healthcare resources are expected to be experienced, and taking into account the limitations of supportive evidence. Treatment allocationAssigning a participant to a particular arm of the trial. UrgencyThe sudden and unexpected experience of an immediate need to void. UrinalysisA test undertaken by dipping a chemical reagent stick into a sample of urine in order to detect substances that may indicate a disease (i.e protein, blood or glucose) or urine infection (i.e leucocyte esterase, nitrites). UtilityA measure of the strength of an individual’s preference for a specific health state in relation to alternative health states. The utility scale assigns numerical values on a scale from 0 (death) to 1 (optimal or ‘perfect’ health). Health states can be considered worse than death and thus have a negative value. Vesico-urethralRelating to, or connecting the urinary bladder and the urethra. VoidingPassing urine – ‘weeing ’. The phase during which the bladder expels its contents (urine). WakingWaking means waking a child from sleep to take them to the toilet. What intervention might the nurse suggest as helpful for the child with enuresis quizlet?What intervention might the nurse suggest as helpful for the child with enuresis? If a child is experiencing enuresis, liquids after dinner should be limited and the child should routinely void before going to bed.
What is the nurses best advice to a parent about a preschooler's imaginary friend?The nurse's best advice to a parent about a preschooler's "imaginary friend" would be that: it is common for preschoolers to have imaginary friends. The nurse suggests a measure that might be helpful for the child with enuresis, such as: decreasing fluid intake after the evening meal.
Which intervention is considered inappropriate when disciplining preschool children quizlet?Which intervention is considered inappropriate when disciplining a preschool child? Administer spanking for dangerous behaviors because research shows that spanking is not an effective toold for discipline.
Which response would the nurse have to parents who are worried about their child's imaginary friends?The nurse's best advice to a parent about a preschooler's “imaginary friend” would be that: having imaginary friends is a sign that the child has a low self-esteem. it is common for preschoolers to have imaginary friends.
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