SN a research psychologist performed an audit of all children referred to the Royal Hospital for Sick Children (RHSC) Glasgow with constipation for a three month period from the 1st March to 31st May 2006. A cut-off point for the audit was set as 12th of September 2006. This audit compared the care given with external standards established in 2001 . The pertinent minimum standards were: (a) appointments – no child should wait longer than one month between the referral being received and the first appointment being offered, (b) appointments – no child should wait longer than 3 months between the referral being received and the actual date of the first appointment, (c) general follow-up – follow-up supervisory contact should be within 2 weeks of the first appointment by visit or telephone, (d) fail to attend should be sent one further appointment.
The modalities of care given were also described (e.g. history, examination, investigation, medical treatment, behavioural intervention, education).
A modified parent satisfaction questionnaire for children with constipation was also administered . The parent satisfaction scale was adapted from the scale used by Sullivan . The scale covered the following domains: (1) provision of information, (2) empathy, (3) technical quality and competence, (4) attitude towards the patient, (5) access and continuity, (6) overall satisfaction. The satisfaction questionnaire involved parents reading 12 brief statements and responding to them on a 5-point scale. The five points were: strongly agree, agree, not sure, disagree, and strongly disagree. In addition parents were asked 3 open ended questions: What did you like most about your care? What did you like least about your care? Do you have any suggestions for improvements? This questionnaire was sent out to the 17 parents who attended their first appointment. A telephone questionnaire was administered to those who failed to return the written questionnaire.
Designing a nurse-led intervention, piloting the intervention and teaching it to a nurse
An expert group was formed in 2007. A clinical psychologist (PG) had many years experience treating constipation and soiling. He had expertise in education of parents and child about how the bowel works and what can go wrong . He was also a behavioural therapist , instructing parents to help their child to sit on the toilet on a regular daily basis to try to pass a stool. An experienced general paediatrician (DT) had implemented a nurse-led service for nocturnal enuresis . He updated the Cochrane Review of Behavioural and Cognitive Interventions  and was a member of the NICE guideline development group for constipation in children – CG99 . He provided expertise on assessment to rule out organic pathology via history and examination and other investigation if required. He also advised on prescription of medication. An experienced children’s nurse and nurse educationalist (TM) helped to develop the nurse-led package of care. SN was a chartered psychologist who had obtained a research PhD supervised by PG and DT, examining new methods of care for night-time wetting . She joined the expert group and undertook the initial audit of GP referrals. SN developed assessment tools and piloted the new intervention within general paediatric clinics run by DT.
This group met on 6 occasions and developed an intervention based on the roles and experience of each group member. Group consensus chaired by DT produced agreement about the final intervention strategy. Experience was included from the pilot phase where SN acted as a ‘nurse’ supervised by DT as the responsible paediatrician.
Funding was provided by the Director of Public Health Glasgow to employ a full time nurse to provide the intervention. CM, an experienced children’s trained nurse and health visitor, was employed and taught the new intervention by SN and DT. This was achieved by direct observation supported by a handbook created by PG, followed by supervision of cases by SN and DT.
Medline, Embase and Cinahl databases 1946/7 to the present, were searched to discover reports of trials of nurse-led services for children with constipation, using the Boolean word AND. The resulting hits were limited to human, English language, constipation in the title, with an abstract available. The titles were read and drug trials, procedural trials such as electrical stimulation, food additive trials, and biofeedback trials were removed. Cinahl produced 9 hits, Embase 9 hits, and Medline 11 hits. The abstracts were read. On reading these abstracts, the only trial comparing nurse-led and doctor-led services was the trial run by Burnett and Sullivan [7, 12]. The intervention used by this group was not described in detail in either of these articles but was described in some detail in a supplementary publication . A further literature search was performed as above replacing trials with nurse. A description of a nurse-led intervention for children with constipation and soiling was called IMPACT . Comparison of IMPACT with the intervention designed by our expert group will be made in the Discussion section.
Using SN as a second ‘nurse’ therapist, CM and SN established their own child constipation clinics. These were situated within established outreach general paediatric services. SN and CM were supported by consultant paediatricians who were generally on-site at the same time seeing patients of their own. This model follows the successful nurse led care pathway for night wetting in Glasgow . Glasgow outreach general paediatric services are geographically based usually in large GP run health centres and patients are allocated to them by their postcode of residence. SN and CM were able to cover about half of the outreach general paediatric clinics. This was dependent on the availability of an extra room for the ‘nurse’. SN and CM therefore had regular slots at clinics covering half the city of Glasgow. Children with constipation referred by GPs who lived in the other postcode areas were treated in a routine way by consultant paediatricians alone. These children acted as a comparison group for the new nurse-led service.
All GP general paediatric referrals were secondarily vetted by DT every two weeks over a 7 month period between March and November 2009. Eligible patients were GP referrals, aged 0–13 years, from postcode areas in the City of Glasgow. To be included the main complaint in the referral letter had to be constipation. Other conditions that made a simple nurse-led intervention inappropriate had to be absent e.g. Autistic Spectrum Disorder. Allocation to either the new nurse-led intervention or the comparison group depended on postcode of residence.
Both groups were contacted by SN at least 16 weeks after their first appointment via a structured telephone interview to provide outcome data. The primary outcome was a measure of constipation less than 3 stools per week[2, 15] for all children, and soiling in the last week for children greater than 4 years. Secondary outcomes were: 1. parent satisfaction with the service, 2. still taking medication at follow-up, 3. overall better than prior to first clinic visit, 4. pain passing stools in the last week, 5. with-holding behaviour during the last week, 6. stool that blocked the toilet in the last week. Parent satisfaction was measured in the same way as in the audit, as the average over 12 questions on Likert scales of 1–5 where 1 was always the most positive and 5 the most negative. SN was blind to allocation status prior to follow-up telephone contact unless she had seen the patient herself and the patient remained particularly memorable to her. She remained blind to allocation unless the parent informed her of allocation status during the telephone contact.
Analysis was performed based on a cluster design using both intention to treat and per protocol analysis.
Submission was made to the National Research Ethics Service (NRES) via the query facility. Advice indicated that the study was service evaluation and as such did not require to be examined by an ethics committee. Further representation to the chairperson of the local ethics committee was concordant with the NRES decision. Consent was not obtained from parents or children as this intervention was being implemented and evaluated as a service development in Glasgow.