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IF YOU ARE INTERESTED IN RESEARCH COVERING A GENUINE CLINICAL POPULATION TACKLING STAFF SHORTAGES AND WAITING LISTS EVIDENCE FROM RANDOMISED CONTROLLED TRIALS

A randomised controlled trial on a real clinical population that shows therapy effectiveness for children with communication impairment? If this sounds like someone is flying kites, meet Jan Broomfield who gave the Kids communication Impairment: Therapy Effectiveness project its wings

as your service or department ever been faced with a serious staffing crisis? Do you want to contribute to the evidence base for the profession? The paediatric speech and language therapy team in Middlesbrough were in just this position in 1997 and dealt with the situation as an opportunity. As team leader, I sought funding for a randomised controlled trial and analysis / evaluation time and discussed post-graduate research qualifications with the local speech and language therapy training university, Newcastle upon Tyne. Over 100,000 was secured from the then NHS Executive (Northern and Yorkshire Region) and I enrolled for a PhD. The KITE Kids communication Impairment: Therapy Effectiveness project - was born. The intention of the study was to conduct a randomised controlled trial, looking at issues such as treatment versus no treatment and the timing of intervention - effectively the impact of waiting lists. The influence of population factors, case history issues and co-occurring deficits on these outcomes will be looked at in detail at a later date. However, when I looked at the literature about the nature of the a caseload, I found little information. So the study became two-fold, incorporating not only the therapy effectiveness elements, but also investigating the nature of referrals received.

The mainstream paediatric service has a service head / team leader whose specialism is phonological disorders a clinical co-ordinator whose specialism is cleft palate, ENT and related disorders two senior specialists in specific speech and language impairment and dysfluency one specialist in language unit / language resource base generalist therapists who have paediatric services as part of their caseload and speech and language therapy assistants. This equated to 6 whole time equivalent therapists and 3 whole time equivalent assistants in post at the start of the study.

Randomisation was conducted off-site, and assessing therapists, treating therapists and assistants were all blinded to the group allocation of each child in their care.
The service is based in five community clinics. There are over 100 primary schools in the locality, and the move to school-based services has not yet happened due to sheer numbers and the desire to base service reconfiguration on sound evidence, which is starting to be available. However as Sure Start programmes become integrated into Childrens Centres in England and services are asked to follow this ethos, we hope to start the transition to locality speech and language therapy teams and increase our contact with schools and nurseries in the near future.

Population
Middlesbrough Primary Care Trust provides speech and language therapy services for children in the Middlesbrough and Redcar Cleveland areas in the North East of England. The population is in the region of 300,000 and there are 4,000 new births each year. Nine Sure Start projects have been set up in the locality (after recruitment to the study), and four wards fall into the top ten most deprived in the UK (www.statistics.gov.uk). Much of the population resides in urban areas, but there is a proportion of rural and farming communities. The speech and language therapy service of Middlesbrough Primary Care Trust has two main sections mainstream paediatric, including language units / resource bases and assessment classes / support bases in mainstream schools, and special needs, including learning disability, physical disability, hearing impairment and autistic spectrum disorders. The speech and language therapy service for adult neurological / acquired disorders is provided by South Tees Acute Trust. Additionally, the nine Sure Start programmes in the locality have speech and language therapy provision that is seconded from Middlesbrough Primary Care Trust.

Frameworks
As much of our direct therapy contact occurs in small groups, often run by experienced assistants and supported by therapists, the department has developed clinical criteria and care pathways. This enables an equitable service to be given by all staff. Further, we have developed therapy packages containing objectives, resources and homework packs for our most common therapy targets, so that the assistants have frameworks available off the shelf for much of their work. Clearly each staff member adjusts and adapts the framework to their style and the individual cases they are seeing, but the basics remain the same. The packages are based on established therapy procedures such as Derbyshire Language Scheme (Masidlover & Knowles, 1982), phonological contrast therapy including Metaphon (Dean & Howell, 1994), Core

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flying KITEs
Vocabulary (Dodd, 2005) and articulation therapy (Van Riper, discussed in Weiss et al., 1987). At the time of the study (19992000), our waiting time between referral and assessment was eight weeks, and those children receiving immediate treatment waited a maximum of six weeks from assessment to treatment. Between January 1999 and April 2000, we received 1100 referrals. Of these, 164 failed to attend for assessment and 108 were found to be within the norm and were discharged at their first appointment. Given the short time between referral and assessment, there was not time for problems to have resolved, so there is an issue around training referrers although this finding matches that of Enderby & Petherham (2001) and therefore is not unique. Of the remaining children, 58 presented with dysfluency as their main difficulty, 22 with ENT related difficulties and 8 were transferred to the special needs team for complex needs; the other 740 had speech / language difficulties as their main presenting problem, and of these 730 consented to be involved in the study. It is these 730 who are discussed here (only 10 of these dropped out during the first six month phase and 20 more over the second). Of the 730, 50 per cent were referred by their health visitor, 23 per cent by school staff and 11 per cent by parents. Almost 75 per cent were less than five years old, with 22 per cent aged two, 27 per cent aged three, 19 per cent aged four and 6 per cent aged 1 (typically almost 2). The age range was 1;9 years to 15 years. There were three boys for every girl. Twelve per cent were identified as having severe / profound difficulties, scoring at below minus 2 standard deviations on formal assessments, and may therefore be classed as having specific speech and language impairment (WHO definition, 1993). The socio-economic distribution reflected that of the local population, which fits a known pattern of referrer selection in areas of high deprivation. Referrers tell us that, whereas they refer almost everyone with communication difficulty from affluent areas, they are selective in areas of high deprivation and dont tend to refer for straightforward delays as theyd refer almost every child. Instead, they refer if there is parental concern because they are more likely to attend and / or where the communication difficulty is severe and / or a high priority for the child and family. Case history factors considered were language onset, general development, hearing, health / medical, feeding, behaviour, family history, family size and care concern. For each case history question no more than 31.5 per cent of responders reported a difficulty, so for each issue at least 68.5 per cent of responders reported no concerns. Every combination of case history factors was found, from none to all. The most common occurrences were behaviour of concern to parents (31.5 per cent), early language delay (30.5 per cent had first word after 18 months) and developmental delay (30.5 per cent walked after 18 months). Caseload factors are discussed in more detail in Broomfield & Dodd (2004a; 2004b). Detailed and wide ranging assessments were conducted with every child and in virtually all cases multiple aspects of speech and language development were impaired. The areas assessed were comprehension, expression including expressive vocabulary, speech including error pattern analysis and consistency rating, phonological awareness, oromotor skill, pragmatics and nonverbal ability. We sub-grouped the 730 according to their main area of difficulty 410 language, of whom 224 had a comprehension diagnosis and 186 had an expressive diagnosis, and 320 speech, of whom 184 had phonological delay, 96 phonological disorder (66 consistent and 30 inconsistent) and 40 had articulation disorder. Interestingly, no child was identified as having developmental verbal dyspraxia at their initial assessment. The study took the form of a randomised controlled trial and this article offers a summary of clinical effectiveness findings. We are preparing papers examining the outcomes but meanwhile readers interested in more detailed statistical information are referred to Broomfield & Dodd (2005a; 2005b).

Randomisation
Interventions were offered over a twelve month period after the recruitment of each individual. Randomisation was conducted off-site, and assessing therapists, treating therapists and assistants were all blinded to the group allocation of each child in their care. We asked parents not to

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Table 1 Summary of study design STUDY PHASE Initial assessment GROUP 1 GROUP 2 GROUP 3

Figure 1 Change in the first 6 months

0 months

0 months

0 months

First treatment No phase (0-6m) Treatment treatment Treatment Interim assessment Second treatment phase (6-12m) Final assessment

The next question is, do waiting lists actually matter? Figure 3 shows the change made when time limited therapy is provided immediately after assessment and within three months of referral (group 1) compared with time limited therapy provided following a six month wait after initial assessment (group 2). Figure 3 Change in group 1 vs group 2

6 months

6 months

6 months

No treatment Treatment Treatment

Treatment

No Treatment

(adjusted t test, t=11.58, p < 0.001)

12 months 12 months 12 months

say anything to assessing therapists until after the assessment was completed, and also asked them not to discuss group allocation with treating therapists; therapists reported that parents rarely commented and stuck to the agreement. Children were randomised into one of three groups group one was the immediate treatment group, group two was the deferred treatment group and group three was the ongoing treatment group (see table 1). It is important to remember that children followed established care pathways during their treatment phases and therefore contact was rarely weekly ongoing therapy. Typically, children received a 6-12 week block of weekly therapy followed by a review period. The average contact time was eight hours, with the range being 0-27 hours. Change is measured in z scores a standard measure converting all assessment scores to a single scale (rather than trying to contrast standard deviations / standard scores / age equivalents depending on the assessment used). A z score of zero means that age commensurate progress was maintained but no loss or gain occurred so a child with an two year performance lag at initial assessment continues to have a two year lag when re-assessed six months later. A positive z score shows catch-up for example a child who moves from -2 standard deviations to -1.5 standard deviations in six months, or a 2 year lag to an 18 month lag, will have a z score of 0.5 for that time period. Conversely, a negative z score shows that the deficit is growing such as a child who moves from -1.5 standard deviations to -2 standard deviations, or an 18 month lag to a 2 year lag, will have a z score of -0.5. The findings reported here show only the mean change for each group. Figure 1 compares change in the first 6 months between the treatment groups (group 1 + group 3) and the no treatment group (group 2).

The difference is clear children in treatment made much more progress overall than those receiving no treatment. It is important to compare with no treatment to reflect natural spontaneous change. But does diagnosis affect this finding? Figure 2 shows the mean treatment and no treatment outcomes for the first six months for each diagnostic category. Figure 2 Mean outcomes by diagnostic category

(adjusted t test, t=3.02, p = 0.003) The difference is less remarkable this time, but is still apparent. Children receiving therapy sooner do better when therapy input is limited. Again, does diagnosis affect this finding? Figure 4 shows the mean outcomes of immediate and deferred intervention for each diagnostic category. Figure 4 Group 1 vs group 2 by diagnostic category

It is clear that the greatest overall therapy impact was made for the diagnosis of comprehension difficulties. However, both comprehension and expression cases made a degree of spontaneous change, and this is far less in evidence in any of the speech types. This finding may help service prioritisation and focus, in that children with speech difficulties where we dont see progress without intervention may be more in need of direct speech and language therapy, while more indirect work with children with language problems may still effect major change. We made the least difference with the expressive group and so are reconsidering our provision as there is a question over effectiveness and efficiency when compared with the other groups.

It is clear that, for all diagnoses except one, waiting for six months prior to beginning intervention slows progress made. This is particularly marked for comprehension difficulties and for articulation disorder. (The inconsistent phonological disorder category had small numbers and therefore the findings were not powerful. However, as the results buck the general trend, they warrant further investigation.)

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Implications for practice

The findings have a number of implications for practice: 1. There is a clear need to consult referrers about who they refer, in an effort both to reduce the normal cases referred and to address the selection issues in lower socio-economic areas. 2. The issue of case history taking needs to be considered. Since no clear aetiological or influencing factor was identified, what is the purpose of these questions and how can we be sure that we are sourcing information accurately? We need to be asking ourselves how reliable the responses we get are, and if there could be a better way of finding the answers we really need to know. 3. The issue of assessment appears clear. Since 12 per cent of cases had complex severe / profound difficulties, and very few children had problems isolated to one aspect of communication (Broomfield & Dodd 2004a; 2004b) there is a need for assessments to be broad ranging (van der Gaag, 1995). 4. Treatment, based on care pathways and intervention packages and delivered in clinics, has been shown to be effective. However, there is differential impact between diagnoses. Perhaps different service delivery models should be considered for different diagnoses at least until evidence to the contrary is available. 5. Waiting lists have a detrimental effect. Although the difference in outcome between immediate intervention and a six-month wait is small, there may be a cumulative effect. Further, even with a six month wait, each case is likely to require additional input to achieve the same outcome, leading to longer waiting times, and so the vicious circle continues. It may be that this evidence can be used to secure waiting list initiative moneys for services.

language stimulation activities with under-fives (Sure Start projects) implementing diagnostic language groups with 5-7 year olds with significant language difficulties (Key Stage 1 in the English school structure) to identify specific language impairment and therefore prioritise such cases for more intensive input providing advice, support and guidance for children aged over 7 with language difficulties, developing curriculum linked targets integrated into the Individual Education Plan conducting diagnostic speech groups with all children who have a speech deficit of over 12 months, enabling differential diagnosis followed by specific therapy approach to be made, as appropriate making client concern and commitment to change key in dealing with articulation disorders.

Acknowledgements
I would like to thank the children and families involved in the study, the paediatric speech and language therapy staff, both past and present, the NHSE for funding and Professor Barbara Dodd for her endless patience, support and enthusiasm.

References
Broomfield, J. & Dodd, B. (2004a) Children with speech and language disability: Caseload Characteristics, International Journal of Language and Communication Disorders 39(3), pp. 303-324. Broomfield, J. & Dodd, B. (2004b) The nature of referred subtypes of primary speech disability, Child Language Teaching and Therapy 20(2), pp. 135-151. Broomfield, J. & Dodd, B. (2005a) Epidemiology of speech disorders, in Dodd, B. Differential diagnosis and treatment of children with speech disorder. 2nd edn. London: Whurr, pp. 83-99. Broomfield, J. & Dodd, B. (2005b) Clinical effectiveness, in Dodd, B. Differential diagnosis and treatment of children with speech disorder. 2nd edn. London: Whurr, pp. 211-230. Dodd, B. (2005) Differential diagnosis and treatment of children with speech disorder. 2nd edn. London: Whurr. Howell, J. & Dean, E. (1994) Treating phonological disorders in children. London: Whurr. Masidlover, M. & Knowles, W. (1982) Derbyshire Language Scheme. Derbyshire: Derbyshire County Council. Petherham, B. & Enderby, P. (2001) Demographic and epidemiological analysis of patients referred to Speech and Language Therapy at eleven centres, 1987 1995, International Journal of Language and Communication Disorders 36(4), pp. 515-525. van der Gaag A. (ed.) (1995) Communicating Quality: professional standards for Speech and Language Therapists. London: Royal College of Speech & Language Therapists. Weiss C., Gordon, M. & Lillywhite, H. (1987) Clinical management of articulatory and phonologic disorders. Baltimore: Williams and Wilkins. World Health Organisation (1993) The ICD-10 classification for mental and behavioural disorders in children: diagnostic criteria for research. Geneva: W.H.O. DENCE?

We have spent some considerable time looking at the findings and the implications in detail and changing the face of our service One-day workshop
In response to requests for information about the study and its findings, together with a desire to make the findings real for individual therapists and services, I have developed a one-day workshop which not only explores the study findings in more detail, but also encourages participants to consider how they can use the evidence to influence their practice. Workshops can be run in a locality or region whereby participants subscribe on an individual basis, or for individual services, perhaps as part of a service review exercise.

Children receiving therapy sooner do better when therapy input is limited. Changing the face of our service
So, based on the findings of the study, what have we done in Middlesbrough? We have spent some considerable time as a department looking at the findings and the implications in detail, consulting with senior level staff in both health and education and changing the face of our service. The key changes we have implemented - many as pilots or under ongoing monitoring so we can make informed comparisons - are a rolling training programme for health visitors a package of training programmes for school staff conducting language health promotion and

Jan Broomfield is a consultant speech and language therapist (paediatrics) working for Middlesbrough Primary Care Trust. For further information, please contact Jan at Speech and Language Therapy Department, 157 Southfield Road, Middlesbrough TS1 3HF, tel. 01642 246603, e-mail jan.broomfield@nhs.net.

REFLECTIONS
DO I RECEIVE PROBLEMS AS A BURDEN OR AN OPPORTUNITY FOR CHANGE? DO I QUESTION THE VALUE OF ROUTINE TASKS SUCH AS CASE HISTORY TAKING? DO I CHECK MY PRACTICE AGAINST NEW EVIDENCE?

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