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Main Report W Hauptreferat W Rapport principal
Folia Phoniatr Logop 1998;50:165–182
Tanya M. Gallagher
McGill University,
Montreal, Que., Canada
Treatment Research in Speech,
Language and Swallowing: Lessons
from Child Language Disorders
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Key Words
Treatment research W Child language intervention W Clinical trials W
Outcomes
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Abstract
Three major types of treatment research methodologies are described. Studies on child language intervention are reviewed as examples of trends and methodological issues characterizing treatment research in
speech, language, and swallowing within the last 2–3
decades. Principles are drawn from that literature and
suggestions for future directions are discussed with
particular attention to recent efforts to support clinical
trials and treatment outcomes research.
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Behandlungsforschung bei Sprach-, Sprech- und Schluckproblemen:
Lehren aus kindlichen Sprachstörungen
Drei besondere Forschungsmethoden betreffend Behandlungen werden beschrieben. Untersuchungen
über kindliche Sprachprobleme werden als Beispiele
für Bestrebungen und methodische Versuche in der
Behandlungsforschung von Sprech-, Sprach- und
Schluckstörungen der letzten 20–30 Jahre vorgestellt.
Aus dieser Literatur werden Prinzipien herausgearbeitet und als Vorschläge für künftige Behandlungen mit
besonderer Unterstützung der neuesten Forschungsresultate ausgearbeitet.
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Recherche en thérapie du langage et de la déglutition: enseignement tiré des troubles
langagiers de l’enfant
Trois principales méthodologies de recherche thérapeutique sont décrites. Une revue des études portant
sur l’intervention dans le langage des enfants exemplifie les tendances et les points méthodologiques caractéristiques de la recherche thérapeutique dans les domaines du langage, de la parole, et de la déglutition durant
les 2–3 dernières décennies. Des principes découlant
de la littérature et des suggestions concernant les directions futures sont discutés avec une attention particulière aux efforts récents appuyant les essais cliniques et
la recherche aux fins thérapeutiques.
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© 1998 S. Karger AG, Basel
1021–7762/98/0503–0165$15.00/0
Fax + 41 61 306 12 34
E-Mail karger@karger.ch
www.karger.com
This article is also accessible online at:
http://BioMedNet.com/karger
Tanya M. Gallagher, PhD, Professor and Associate Dean
University Affairs, Planning and Resources, McGill University
Office of the Dean, McIntyre Medical Sciences Building
Montreal, Quebec H3G 1A8 (Canada), Tel. +1 (514) 398 3499
Fax +1 (514) 398 3595, E-Mail gallagher@minerva.medcor.mcgill.ca
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ABC
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Folia Phoniatr Logop 1998;50:165–182
Table 1. Major treatment research designs
Treatment efficacy research
Randomized or fully specifiable assignment
Well-controlled conditions
Causal interpretations
Treatment effectiveness research
Nonrandomized assignment
General specification of conditions
Comparative interpretations
Treatment outcomes research
No comparison groups
Typical conditions
Trends and associations
ment can be interpreted as directly attributable to that treatment. Randomized controlled clinical trials are an example of this
type of research.
Treatment effectiveness research is a research design that involves nonrandomized
assignment to intervention and control
groups and general specification of treatment
methodologies. Within this design, the potential influence of confounding variables is not
as well controlled and, therefore, causal interpretations and generalizability of the results
obtained are weakened. Comparative treatment studies are an example of this type of
research.
Treatment outcomes research is a research
design with no clearly specified comparison
groups or treatment methodologies. Functional outcomes research describes functional
changes in the lives of patients following treatments provided by typical providers, in typical treatment settings, with typical clients, under typical treatment conditions. Within this
design, only trends and associations can be
reported. Patient databases are examples of
this type of research.
Each of these research methodologies contributes complementary information to our
Gallagher
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The demand for information on the efficacy, cost-effectiveness, and functional impact
of speech-language pathology treatment on
the quality of life of people served has escalated dramatically throughout this decade. Although the need for information on treatments has long been recognized, several factors have contributed to the accelerated interest and sense of urgency that has characterized the 1990s. Aggressive time frames for the
incorporation of treatment information into
decision-making processes have placed considerable pressure on speech, language, and
swallowing service providers to collect data to
manage programs, advocate for services, and
enrich the scientific knowledge base underlying the development of practice guidelines
and critical care paths [1–4]. Among the factors that have contributed to this situation in
many countries are efforts at health care cost
containment and health care reform in the
context of scarce and competing resources;
increased attention to treatment evaluation
and outcomes by national agencies responsible for health care standard setting, standard
monitoring, financing, and health care policy
and research and, the growing acceptance of
outcomes measurement as a comprehensive
and distinctive research methodology combining elements of clinical epidemiology and
information technology as well as more traditional research designs [5–7].
As a comparatively recent research methodology, a great deal of variability exists in the
terminology used to refer to different types of
treatment research. Within this paper, three
basic treatment research methodologies will
be defined as follows [8–10] (table 1):
Treatment efficacy research is an experimental research design that involves randomized or fully specifiable assignment to subject
groups and studies treatment methodologies
under well-controlled conditions. Within this
design, any change measured following treat-
knowledge of treatments. Each is characterized by different strengths and weaknesses.
Each serves different purposes and entails different interpretative cautions.
Treatment efficacy research, traditional in
experimental design and often referred to as
the ‘gold standard’ of clinical research, is the
only design that permits strong causal statements to be made. These types of studies are,
therefore, critical to the evaluation and development of clinical procedures. They are expensive, however, and the use of no-treatment
conditions often raises ethical concerns. A
further difficulty is the very experimental
control that supports the robustness of data
interpretations of these types of studies.
Treatment efficacy studies can assert that
changes were the direct result of treatment
procedures but only within the conditions
tested. The generalizability of clinical trials
results to typical treatment settings cannot
simply be assumed since the very controls
that are the hallmark of the design may create
subject inclusion and exclusion conditions,
and treatment delivery conditions that are not
representative of most treatment settings
serving typical clients.
Treatment effectiveness research, although
only permitting comparative statements and
analyses of trends and associations, is costeffective and addresses some of the ethical and
methodological concerns raised about efficacy
studies. Outcomes research can only make descriptive statements and cannot ascribe
changes in behavior directly to the treatments
delivered, but those statements describe patients following typical interventions within
typical settings for most people being served.
The interpretive stength of outcomes research
depends upon the size and robustness of the
database. Representativeness is achieved
when the outcomes database is so large that it
includes, or does so as nearly as possible, the
population the database is describing.
Treatment efficacy research contributes
precision and definitiveness, treatment effectiveness research contributes a cost-effective
means of exploring the promise of treatment
directions, and outcomes research contributes
an understanding of real world practice trends
and the functional impacts of treatment programs on patients’ lives. Each type of research
is complementary and synergistic and, therefore, each is necessary to provide a balanced
and comprehensive view of speech, language
and swallowing therapy.
A review of most treatment studies to date,
however, indicates that researchers in speech,
language, and swallowing have primarily utilized treatment effectiveness research designs.
There have been few treatment efficacy or
treatment outcomes studies in speech, language, and swallowing. Within this paper,
studies on child language intervention will be
reviewed as examples. Principles will be
drawn from what that literature illustrates
about the conduct of treatment research in
general. Finally, suggestions for future directions will be discussed with particular attention to the American Speech-Language-Hearing Association’s (ASHA) efforts to support
clinical trials and treatment outcomes research.
Treatment Research in Speech,
Language and Swallowing
Folia Phoniatr Logop 1998;50:165–182
Review of Child Language Intervention
Research
Child language intervention is a comparatively recent area of practice. Prior to the
1960s intervention with children focused primarily on speech production, and language
therapy was infrequent and restricted in
scope. Since that time, child language intervention has become a major area of practice,
reflecting successive theoretical influences:
behaviorism in the 1960s [11, 12], generative
syntax in the 1970s, and pragmatics in the
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mance. Most research has compared the effects of different intervention procedures and
different intervention agents.
Intervention Research: Procedures
Language intervention techniques have
been described as a continuum that is anchored at each extreme by procedures derived
from widely different language theories [18,
21]. At one end are procedures reflecting behavioral theories such as stimulus presentation, response imitation, and external reinforcement. Behaviorally oriented language
therapy programs use highly structured approaches that isolate language targets from
natural contexts in order to increase their saliency, facilitate the elicitation of direct imitations and performance monitoring, and increase the reinforcement value for correct performance. At the other end of the continuum
are procedures derived from generative and
pragmatic theories such as focused stimulation, modeling, and expansion/recasting.
Generative and pragmatic language therapy
programs attempt to approximate the normal
language learning situation and increase the
frequencies of natural opportunities for learning, provide nondemanding models and expansions/recasts, follow the children’s lead,
and increase the children’s access to the naturally occurring rewards for communication.
Along the continuum are hybrid models of
intervention that combine features of both
extremes in varying proportions.
Many studies have explored whether one
intervention procedure or program is superior
to another in facilitating syntactic development. Recent studies have examined imitation, and more interactive, naturalistic approaches such as modeling and expansions/
recasts, and hybrid approaches such as milieu
training. Imitation has most often been com-
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1980s and 1990s [see ref. 13–16 for reviews].
Despite the element of truth in a recent description of language acquisition theories as
being a ‘confusing morass of theories, subtheories, minitheories, ideas, perspectives,
concepts and critiques’ [17], child language
intervention has continuously evolved its
content, procedures and indices of success
over the last 30 years.
Over 200 studies of child language treatment have been conducted. Most of these
have been single-subject or comparative treatment effectiveness studies of syntactic performance. They have included small numbers of
children, interventions taking place over brief
periods of time, circumscribed measures of
effectiveness, and dependent measures sampled within treatment setting contexts. The
results of these studies have been very encouraging. The overwhelming majority have reported positive overall effects of intervention
on syntactic performance [14, 18, 19]. The
meta-analysis of 43 studies of language intervention with language/learning-disabled children by Nye et al. [20] reported an effect size
that clearly supported this conclusion.
Although a great deal of progress has been
made, fundamental questions remain. Among
these are: how much of the improvement that
has been reported is due to overall maturation
and how much is due to the treatments provided; have performance gains in therapy generalized to nontreatment settings and been
incorporated into the children’s daily lives;
what effects do performance gains have on
other areas of the children’s functioning; what
intervention procedures and programs result
in the greatest performance changes and, what
intervention agents should be involved in effective and efficient service program delivery.
Most of the experimental treatment studies in the 1980s and 1990s have addressed the
last two questions relative to syntactic perfor-
pared to each of these more interactive approaches but procedural definitions have varied, making comparisons across studies difficult.
For example, Connell [22] investigated the
syntactic rule induction learning patterns of
40 preschool specifically language-impaired
(SLI) children and 40 age-matched controls
using two intervention procedures, imitation
and modeling. Imitation was defined as repeating clinician models following direct
prompts. Corrective feedback was provided
and praise was used as a reinforcer. Modeling
was defined as demonstration. Children were
cautioned to listen only and not attempt to
repeat and their attention to the task was
praised. The learning context in both conditions was a highly structured picture presentation task. Children were taught an invented
morphological suffix rule for nouns, ‘a’ meaning ‘part of’ (e.g. ‘cow-a’). No performance
differences between imitation and modeling
were found for the age-matched control subjects, but the SLI subjects performed better
when the instructional technique was imitation rather than modeling. Since rule mastery
within this study was assessed only by means
of production trials, Connell and Stone [23]
extended the study using comprehension and
production performance trials. Within the
Connell and Stone [23] study, SLI children’s
performance was also compared to two
groups of children who were developing language normally, chronologically age-matched
controls and younger language-matched controls. The children were taught four invented
morphemes using the same procedures as in
the earlier study. The results on production
performance did not change. No differences
between procedures were found for the normal language control groups, and production
performance differences favoring imitation
were noted for SLI subjects. The comprehension data, however, clarified that the SLI chil-
dren’s preferential learning responses to imitation were due to production practice effects
and not true rule learning differences. There
were no differences between procedures for
all three subject groups within the comprehension data. Both imitation and modeling
were equally effective for all subjects. These
studies suggest that for SLI subjects, imitation
facilitates grammatical production but both
imitation and modeling are equally effective
for comprehension.
Camarata and Nelson [24] and Camarata
et al. [25] compared imitation with a more
naturalistic intervention technique, conversational recasts. Imitation was defined as it was
within the study by Connell and Stone [23]
and the learning context was the same, a picture presentation task. External reinforcements as well as verbal praise, however, were
used with this procedure. Conversational recasts were defined as clinician restatements of
children’s utterances that preserve their
meaning and incorporate target structures as
syntactic expansions. The context for the conversational procedure was less structured.
Play activities were organized so that they
maximized opportunities for learning the targets. Open-ended prompts were used and no
explicit reinforcers were included. All children received both techniques, each for different intervention targets. There were 4 SLI preschoolers in the 1992 study and 21 SLI preschoolers in the 1994 study. The intervention
programs were 16 and 12 weeks, respectively.
For most children and most targets, when imitation procedures were used, the children’s
elicited productions of the syntactic targets,
correct repetitions immediately following target productions, occurred more rapidly.
When conversational intervention procedures
were used, spontaneous productions of targets
occurred more rapidly. Individual differences
among targets and children were noted in
both studies. The results as a whole suggest
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Language and Swallowing
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instructional procedures. First, the original
assumption that one procedure would be
found to be superior to all others will have to
be revised. The results as a whole suggest that
all of these procedures are useful in particular
situations depending on the purpose [24, 25],
the modality [22, 23] and the characteristics
of the children [21]. At this point, it may be
more appropriate to ask a more complicated
question than the one originally posed. For
example, the question might be what procedure along the continuum is most effective for
this type of child with these handicapping and
complicating conditions, for this language target, at this stage of mastery, with this socialbehavioral profile, and this type of home and
school environment. Our understanding of
some of these variables is in its infancy.
Second, research methodologies must continue to evolve relative to their precision and
degree of experimental control in order for the
research and clinical communities to derive
maximal benefits from these efforts. The following methodological issues warrant particular attention:
(1) Subject Description. Subject characteristics including receptive, expressive and
pragmatic language characteristics, chronological age, cognitive level, handicapping and
complicating medical conditions, and school
placement should be specified. Further, subject inclusion characteristics should be clear
and consistently applied. Although considerable progress has been and continues to be
made, sustained attention to subject description is needed.
(2) Procedural Description. Intervention
procedures should be clearly and fully specified including program characteristics such as
size of intervention groups, frequency and
length of program, and number of trials per
procedure. Variability among these dimensions has made it difficult to interpret the
results of studies relative to each other. As
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that the most effective procedure may be determined by the treatment goal.
Comparison between behaviorally oriented approaches and hybrid approaches have
also been made. For example, Yoder et al.
[21] compared Milieu Teaching and the Communication Training Program [26]. Milieu
Teaching is a hybrid intervention approach
that is naturalistic in the sense that it recommends following the children’s lead and interests and uses naturally occurring events and
consequences to increase the frequencies of
language form use. It is behavioral in the
sense that new forms are taught within naturalistic settings using explicit prompts and
reinforcement [27, 28]. The Communication
Training Program is a highly structured program that specifies number of trials and the
sequence of instructional targets. The program uses behavioral procedures, stimulus
presentation, imitation, practice and explicit
reinforcements. Both programs contained 60
instructional sessions. Forty children served
as subjects and ranged in age between 2 and 7
years. The children were described as having
language and cognitive delays ranging from
near-normal to severely delayed but further
information was not provided. The results
indicated that there were no differences between the treatment groups regardless of
teaching method. Analyses of possible interactions between treatment methods and children’s developmental levels within this study
and others [22–25, 29–31] suggest that there
may be interactions between treatment method and subject characteristics such as language and cognitive level. Given the definitional differences across studies and the incompleteness of some of the subject information provided it is difficult to determine the
nature of those interactions.
The studies that have been reviewed are
illustrative of several things that we have
learned about identifying optimal language
Snow et al. [32] have pointed out relative to
the Camarata et al. [25] study, the terms ‘imitative’ and ‘modeling’ have been variously
defined and usually include elements of both
within each procedural presentation as we
have seen in the studies reviewed. The term
‘naturalistic’ is also difficult to interpret since
it is often incompletely and ambiguously defined. Hepting and Goldstein [33] recently
examined 34 studies of naturalistic language
intervention to determine the common characteristics of the approach. They found components with each study that justified use of
the term, but were unable to identify a common set of characteristics across the 34 studies. Complicating matters further, several elements of intervention programs often vary in
addition to the procedures being compared,
for example, feedback, reinforcers, context,
number of learning trials, and overt practice
opportunities. It is, therefore, difficult to
know which of these factors or combinations
of factors accounted for the results obtained.
(3) Treatment Fidelity. Consistency and
comparability of treatment delivery across
children and clinicians should be documented
in order to strengthen data interpretations.
For example, clinician procedural consistency
was rated within three sessions by Yoder et al.
[21]. True precision in this regard may be difficult to achieve for naturalistic language intervention programs, such as those used in the
studies by Camarata and Nelson [24] and
Camarata et al. [25], given their highly learner-responsive character. These programs by
definition do not provide a list of steps to follow or specific content to be used and indeed
caution against clinician-directed learning.
Therefore, the number of learning opportunities provided within treatment sessions may
be determined as much by individual children’s interests and responsiveness as by the
clinicians’ behaviors.
(4) Documentation. Measures such as
mean length of utterance and developmental
sentence scores should be used with caution to
document child progress. Improvement in
these measures at the higher levels is unreliable [see ref. 34 for review]. Just as gains in
mean length of utterance are not linear with
age for children developing language normally
[35], there is no reason to assume that they
will be linear for children with language disorders. Incorporating a variety of dependent
measures may be most informative.
(5) Control Groups. Control groups need to
be included within comparative treatment
studies to address issues regarding maturational effects. Subjects should also be randomly assigned to treatment conditions as was the
case in the Connell [22], Yoder et al. [21] and
Camarata and Nelson [24] studies. There has
been considerable improvement within treatment studies over the last 10 years in this
regard [see ref. 18, 19, 34 for reviews] but
appropriate matching variables between children who are developing language normally
and those who are not present challenges that
still need to be addressed [36, 37].
(6) Generalization. The effects of language
intervention must be determined beyond the
immediate language learning context and
beyond the short term. Most of the studies to
date have sampled generalization shortly after
intervention in contexts that were similar if
not identical to those in which the intervention took place, with the clinician who presented the program, and using techniques
similar to those used in training.
(7) Content. The focus of language intervention studies needs to be expanded to encompass aspects of language in addition to
syntax, such as conversational language use
[38, 39], and the interrelationships of language proficiency and other areas of the children’s functioning such as their social behavior/social emotional well-being [40], the quali-
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171
Intervention Research: Intervention Agents
Another major type of child language treatment research has explored the treatment effectiveness of programs delivered by parents
[46], teachers [47], and peers [48]. Among
these, programs designed for parents have had
the longest history and have reflected the theoretical influences noted above. Early programs taught parents behavioral operant techniques while more recent programs have incorporated naturalistic interactive techniques
[49]. Examples of current programs include
the Transactional Intervention Program [50],
the Language Interaction Intervention Program [51], and the Hanen Program for Parents [52]. Most parent-administered programs have tended to focus on the young child
or children in the early stages of language
development, have used naturalistic techniques including general stimulation and
have involved limited numbers of subjects.
Recently, studies by Fey et al. [53, 54]
compared the treatment effectiveness of parent-administered programs and clinician-administered programs on the language development of preschool children. Control groups
that did not receive treatment were included.
The programs used focused stimulation procedures, which were similar to the definition
of conversational recasts used by Camarata
and Nelson [24] and Camarata et al. [25].
Opportunities to learn the target were increased in semantically and pragmatically appropriate contexts, targets were modeled, recasts were provided, and children were not
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Folia Phoniatr Logop 1998;50:165–182
directly prompted to use models. Adult communicative behaviors in these studies, however, included false assertions, contingent
queries, and forced-alternative questions to
stimulate child target productions. In addition, the clinician-administered programs included 10 min of imitation practice weekly.
Three visits were made to the homes of parents participating in the program to monitor
treatment fidelity. The results of both studies
indicated that children made gains within
both clinician-administered and parent-administered programs compared to the notreatment control groups. Gains were greatest
for those childen who received clinician-administered intervention, however, in both
phase I, the first 5-month period [53], and
phase II, the second 5-month period [54]. Although gains were not as great during phase II
compared to phase I, they were again evident
for both the parent-administered and clinician-administered programs compared to the
no-treatment groups. Parents demonstrated
that they could learn and use the techniques
presented but they varied in their frequencies
of use within posttest parent-child language
samples. Ongoing monitoring was not possible during the parent-administered programs
so it is unclear how often parents used the
techniques during the two intervention periods.
The results of the no-treatment control
groups were particularly interesting. The notreatment group in phase I were children on
the waiting list for services. The no-treatment
group in phase II were children who had a hiatus in services due to summer vacation. During phase I, half of these children had been in
the parent-administered group and half had
been in the clinician-administered treatment
group. The no-treatment groups within both
studies did not demonstrate gains. The differences between the delayed treatment group
(waiting list group) and both treatment groups
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ty of their relationships [41], and their functioning in other modalities [42–44]. The age
range that has been typically studied also
needs to be extended beyond preschool to
include early language intervention and the
older child and adolescent [45].
in phase I are understandable and an indication of the effectiveness of the programs. In
phase II, the differences between the treatment groups and the members of the dismissal group (summer vacation group) who received clinician-administered programs in
phase I are also understandable due to the
inaccessibility of further services and also indicate the effectiveness of the programs. However, the lack of progress of children in the
dismissal group who had received the parentadministered program in phase I suggests that
the techniques the parents learned in phase I
were not maintained in phase II in the absence of clinician support. Although the number of children involved was small, 10 per
group, and should be interpreted with caution, it suggests that there may be a role for
continued clinician involvement within parent-administered programs and the need for
further investigation of combined parent- and
clinician-administered programs.
Girolametto et al. [55] also examined the
effectiveness of a parent-administered focused stimulation program but the study used
a pretest-posttest control group design with
random assignment to an immediate parentadministered treatment group and delayedtreatment control group. There was no clinician-administered treatment group in this
study. The definition of ‘focused stimulation’
was similar to the one used by Fey et al. [53,
54], but it was not clear whether the adult
communicative behaviors used to stimulate
child target productions that they had included were also included in this study. The
subjects were 25 toddlers at the one-word
stage of language development. Treatment fidelity was determined using checklists during
three home visits. The results of this study
also indicated that parents were able to learn
and use the techniques and that children
in the parent-administered treatment group
made significant gains compared to those in
the no-treatment group. Again individual differences were noted.
Studies of teacher-implemented intervention programs are very limited at this point
but suggest that teachers can also be effective
in facilitating children’s language development and conversational behavior [56, 57].
This type of research will be important given
the increasing use of consultative intervention
models with school-aged language-disordered
children [58, 59].
The role of peers as potential intervention
agents has also been studied. There is a growing literature indicating that peers can be
taught to initiate positive interactions more
frequently with language-disordered children,
to respond more positively to them, and to
serve as peer models, monitors and recorders
[16, 41, 48, 60, 61]. The impact of these interventions on language-disordered children’s
language and communicative behavior as well
as on their frequent peer isolation and rejection warrants further study.
Although the literature on the effectiveness
of intervention agents other than clinicians is
more limited than that on intervention procedures delivered by clinicians, it highlights
many of the same methodological issues (e.g.
small N’s, etc.). The studies suggest that training others, particularly parents, can change
their behavior and possibly enhance children’s language skills. Individual differences
are consistently reported suggesting the potential influence of the same factors as were
discussed earlier (e.g. subject characteristics,
etc.). Furthermore, it is not clear whether parent-administered programs are more effective
in increasing the use of language structures
children have already acquired than in helping them learn new structures [see 49, 62, 63
for reviews].
The studies that have been reviewed, however, represent some of the most sophisticated
research designs that have been used to date
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Language and Swallowing
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173
Implications for the Future
As these exemplary studies of child language intervention illustrate, treatment research has become increasingly sophisticated
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Folia Phoniatr Logop 1998;50:165–182
over the last two decades. A basic clinical
intervention technology has been developed
and tested, and numerous studies have indicated the positive effects of language intervention. As Bricker [14, p. 12] concluded in a
recent review, the progress that has been
made is a major achievement ‘considering the
complexity of human learning, the complexity of language acquisition and usage, and
the short time that investigators and practitioners have been attempting to develop and
implement programs of language intervention’. Although this statement is specific to
child language intervention, essentially the
same conclusion could be reached across areas of speech, language and swallowing treatment research. We have learned a great deal
about how to do treatment research during
the last two decades and the proportion of
studies addressing treatment issues is steadily
increasing.
There are two major challenges for the
future. One is to address the types of questions that we have been researching with increasing precision so that the results can be
interpreted more definitively. The other is to
address questions that have been insufficiently researched, one of the most significant of
these being the functional impact of treatments on patients’ lives and on the health
care and educational service delivery systems
of which they are a part. Both require that
mechanisms be developed to facilitate the
establishment and support the maintenance
of large, collaborative networks among researchers and clinicians.
Although it is certainly the case that progress on many of the methodological issues
discussed will continue to be made at individual sites, for example, subject description,
procedural description, treatment fidelity,
and documentation, progress on others, such
as interactions among specific treatment variables and particular patient characteristics,
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to address questions about child language
treatment and illustrate several important
methodological issues in addition to those discussed in the earlier section.
(1) Subject Selection Bias. The literature
on parent-administered programs more than
any other highlights the potential influence of
subject selection bias on the results obtained.
For example, parents who have participated
in intervention studies have overwhelmingly
been self-selected, highly motivated, middleclass mothers as was the case in the studies
discussed above. Generalization of these findings to the population at large, therefore, cannot simply be assumed.
(2) Treatment Fidelity. Treatment fidelity
and frequency of technique use is very difficult to monitor in parent-administered programs. Periodic parent group meetings and
language sampling techniques have been used
[53–55], but parents’ behaviors in their homes
are still difficult to obtain or reliably estimate.
(3) No-Treatment Control Groups. Each of
the studies reviewed highlighted the interpretive value of including no-treatment control
groups within research designs. The means for
doing so may introduce bias since they tended
to take advantage of events that were beyond
their control (e.g. summer vacation, waiting
lists for services, etc.) and were not truly randomized designs. Despite this potential limitation, they provide a means for reducing some
of the ethical concerns associated with withholding treatment and in so doing provide
mechanisms by which important information
can be added to the treatment literature.
Clinical Trials Research
In 1997 ASHA established the Communication Sciences and Disorders Clinical Trials
Research Group (CSDRG) to provide a
mechanism for preparing an application to
the National Institutes of Health: National
Institute on Deafness and Communication
Disorders (NIDCD). The application was to
support multi-center randomized clinical
trials research in communication disorders.
The application was successful and Dr. Jeri
Logemann serves as the Principal Investivator of the project. Clinicians from various
practice environments (e.g. acute care hospitals, schools, nursing homes, etc.) and researchers from various backgrounds (e.g. clinical and basic science researchers in communication disorders, statisticians, and epidemiologists) were brought together to design and
execute the trials. The CSDRG and the clinical trials that are conducted will be funded by
NIDCD and other institutes and foundations.
The project is organized with ASHA serving
as the fiscal intermediary.
The CSDRG has two components. One
component provides mechanisms for generating suggestions for clinical trials, provides
technical support for designing proposals, and
Treatment Research in Speech,
Language and Swallowing
presents these proposals to NIDCD for consideration. The other component, the protocol management group, supports the implementation of the clinical trial once it has been
approved and funded.
An Executive Policy Board formulates all
policies relative to the conduct of the CSDRG
and is assisted by three subcommittees, a Protocol Writing Subcommittee, a Publications
Subcommittee, and a Quality Assurance Subcommittee. The Protocol Writing Subcommittee develops ideas and helps to prepare
protocols for potential funding to NIDCD.
The Publications Subcommitte is responsible
for all policies regarding publications that
emanate from the work of the group, and the
Quality Assurance Subcommittee has the responsibility to develop and implement a program to ensure that standard practices are
being uniformly followed across all centers
participating in the trials.
The CSDRG also established five clinician-researcher liaison groups, one group in
each of the following areas: speech disorders,
adult language disorders, child language disorders, voice disorders, and hearing impairment/balance. Clinician-researcher groups reflecting various practice settings (e.g. inpatient, outpatient, and schools) were also established to consider issues that may be setting
specific factors that might introduce settingrelated considerations in the conduct of a
trial.
Currently one trial has been initiated. It
will examine two treatments for aspiration of
liquids in elderly patients with dementia or
parkinsonism. Patient accrual began in early
1998 and will continue for 4 years. It is anticipated that other trials will begin in time and
eventually several trials will be conducted
through the CSDRG simultaneously. These
efforts represent a significant advance in the
development of treatment research technologies in speech, language and swallowing, and
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will be unlikely without the large patient numbers multi-site-collaboration permits. This is
even more true for the two types of treatment
research that have been severely underrepresented within the literature to date, treatment
efficacy research and outcomes research. Both
essentially require large collaborative networks among clinicians and researchers.
Since 1993, ASHA has helped to build and
support collaborative networks of researchers
and professionals in order to conduct clinical trials and functional outcomes research.
Those efforts will be summarized below.
Treatment Outcomes Research
ASHA began its efforts to provide treatment outcomes information on speech-language pathology and audiology services by
forming a task force, the Task Force on
Treatment Outcomes and Cost Effectiveness
(TOCE) in 1993. Nancy Swigert and Tanya
Gallagher were Co-project Officers of the
Task Force and Herbert Baum (Director of
ASHA’s Science and Research Department),
Robert Augustine, Audrey Holland, Raymond Kent, Roberta Kreb, Susan Russell,
and Kenneth Wolf served as members.
Among its early activities, the Task Force
evaluated the treatment outcomes data collection systems that were being used nationally.
Three major instruments for adults were being used, the Functional Independence Measure (FIM) [65], the LORS-III [66], and
RESTORE [67]. The first two instruments
were designed for outpatient rehabilitation
settings and the third was designed for inpatient settings.
The UDSmr encompasses the FIM and is
one of the largest nationally aggregated rehabilitation databases available within the
United States. Patient FIM data became
available to participating facilities in 1990
[68]. As of June, 1993, over 300,000 patient
records from 470 inpatient medical facilities
in 48 states had been entered into the database. The FIM uses a seven-point rating scale
with 1 indicating total dependence and 7 indicating complete independence. Communication and swallowing items include eating, auditory comprehension, visual comprehension,
vocal expression, nonvocal expression, social
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interaction, problem solving, and memory.
After studying the FIM the Task Force concluded several important factors limited its
ability to adequately represent treatment outcomes in speech, language, and swallowing.
These included: items that were not specific
enough to adequately characterize the communication processes being assessed; unaccounted for differences among the health care
professionals’ ratings of communication-relevant items; ratings were entered for all scales
regardless of their appropriateness for certain
patient groups (e.g. communication items for
hip replacement patients); ratings were entered whether or not intervention was provided or if provided, how often, and the measure lacked sufficient sensitivity to reflect
changes in communication. The other adult
instruments and the child instruments that
were later examined, the Pediatric Evaluation
of Disability Inventory [69] and the Wee FIM
[70], had many of the same limitations.
The Task Force concluded that despite the
availability and convenience of using these
already established instruments and databases,
ASHA needed to develop instruments and
create a national database for speech-language
pathology and audiology services. Only a national outcomes measurement system would
be comprehensive enough and rigorous enough
to allow national benchmarking, comparisons
of treatment services to a national average,
which was an important feature national and
federal agencies were beginning to demand.
The TOCE developed the basic features of the
National Outcomes Measurement System in
Speech-Language Pathology and Audiology
(NOMS), formulated a strategic plan for implementation of the multi-phase project, and completed its work in 1996. Since that time the
National Center for Treatment in Communication Disorders has been established within
ASHA’s National Office and the NOMS project has been proceeding with the help of an
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ultimately in the knowledge base of the professions and the discipline [64]. Another important ASHA initiative has been treatment
outcomes research.
National Outcomes Measurement
System for Speech-Language Pathology
and Audiology
Four speech-language pathology components of the NOMS have been developed [3]:
NOMS: Adult [71], NOMS: Kindergarten –
Grade 12 (Health) [72], NOMS: Kindergarten – Grade 12 (Education) [73], and NOMS:
Pre-Kindergarten [74]. The NOMS: Adult has
been field-tested, and undergone reliability
and validity testing. Field-testing for the other
components is ongoing, and reliability and
validity testing will follow.
All NOMS components contain four
forms: Admission/Entrance, Discharge/Evaluation of Services, Consumer Satisfaction
(optional), and Financial Information (optional). The K-12 (Education) component
also contains a Functional Status Measures
form. Teachers are asked to use this form to
rate children’s communication within classrooms and its impact on their educational
participation.
The functional communication status of
patients/clients is measured using 7-point
scales at both admission or entrance into
treatment and at discharge or other evaluation points, such as the end of the school year.
Functional communication measure (FCM)
ratings are entered only for those communication disorders being treated. Expert panels
were consulted to write the FCMs, and each
point on the scales represents successive
stages of communicative improvement for the
communicative disorder being treated.
In addition, the following information is
obtained on the Admission/Entrance and Discharge/Evaluation of Services forms: (1) treatment setting; the type of facility on the
Treatment Research in Speech,
Language and Swallowing
NOMS: Adult forms (e.g. acute care hospital, skilled nursing unit, rehabilitation hospital, etc.), or instructional context on the
NOMS: K-12 or Pre-K forms (e.g. day care,
special education classroom, preschool, ect.);
(2) medical diagnosis and associated factors
(e.g. seizures, bronchopulmonary dysplasia,
etc.); (3) primary communication disorder;
(4) date services began and ended; (5) number
of treatment units provided, coded in 15- to
20-min units, and if support personnel were
involved, the number of treatment units by
each type of service provider; (6) model of
SLP services used (e.g. direct treatment, collaborative/consultative, etc.) and if more than
one model was used, the percentage of treatment units provided using each type;
(7) whether treatment goals were met and if
not the primary reason (e.g. funding issues,
medical complications, discharged to another
program, etc.), and (8) where discharged and
whether continued treatment was recommended.
The Consumer Satisfaction Form asks
adult patients/clients or their spouses/caregivers if they are unable to complete the form,
and parents of children to estimate their
agreement with the statements provided using
a 5-point scale that ranges from ‘strongly
agree’ to ‘strongly disagree’. Statements include that their communication/swallowing
abilities improved as a result of the treatment
provided, that those abilities would not have
improved without treatment, etc. The Financial Form indicates total charges, funding
sources, and reimbursements by funding
source.
In order to ensure the comparability of
FCM ratings across clinicians and, therefore,
the integrity of the national database, a rater
registration program was developed. All
NOMS users are provided with training manuals and must pass a test at the 85% level or
above in order to be included in the registry.
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administrative advisory team, Rob Mullen,
Director of the Center, Herbert Baum, Director of the Science and Research Department,
Nancy Swigert, and Tanya Gallagher.
Primary communication disorder
Admission Change
Discharge
Swallowing
Speech production
Spoken language comprehension
Spoken language production
Voice
3.3
4.0
3.9
3.6
3.9
4.8
5.0
4.8
4.6
5.1
Only data from registered users is entered into
the national database. The National Center
maintains the national database, the registration and subscriber programs, and provides
each subscriber program with quarterly reports summarizing their specific data and national reports summarizing the aggregate data
from all participating programs. All national
data is kept strictly confidential
NOMS data can be used by facilities to
describe functional changes that typically follow provision of speech-language pathology
services, to negotiate with reimbursement
agencies and policy makers on a more informed basis, to meet accreditation standards, to benchmark against national and regional trends, to facilitate program planning
and evaluation, and to project potential impacts of proposed program changes on resource and utilization patterns. Having these
kinds of data helps professionals deliver, plan,
and advocate for their services more effectively. The database is also an important means of
identifying clinically focused research questions that can guide the growth of the knowledge base of the professions. For example,
identifying unexplained variations in outcome can lead us to explore the differences
that might exist at the level of procedures and
direct us to frame critical studies of those differences. The data can also direct us to investigate areas of intervention where outcomes
are not as positive as we might have thought
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1.4
0.9
0.9
1.0
1.1
and focus research energies on the development of new procedures.
Preliminary data from 1,638 patients included in the field testing of the NOMS: Adult
component was published in June, 1996 [75].
The data presented in table 2 is a portion of
that data set. It summarizes the mean FCM
scores at admission, the mean change in FCM
scores following treatment, and the mean
FCM scores at discharge for five of the primary communication disorders of adults treated
within acute inpatient facilities. The data indicates that patients with swallowing disorders are admitted to treatment within acute
care inpatient settings at approximately FCM
level 3, on average. The description at that
level read: ‘Swallowing disorder prevents eating for a portion of nutritional needs and oneto-one supervision is required for eating.’ The
mean change score was 1.4 levels and the
mean discharge score was 4.8. Patients are
therefore discharged on average at approximately FCM level 5. The description at that
level read: ‘Swallowing is function to meet
nutritional needs, although self-monitoring
and compensatory techniques are used.’
The data in table 3 summarizes the same
types of data for the same five primary communication disorders. These data indicate
that patients who were treated for spoken language comprehension problems within rehabilitation inpatient facilities were admitted,
on average, at approximately FCM level 4.
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Table 2. Mean admission,
change, and discharge FCM
scores from preliminary testing
of NOMS:Adult within acute
inpatient settings
Primary communication disorder
Admission Change
Discharge
Swallowing
Sprech production
Spoken language comprehension
Spoken language production
Voice
3.7
3.7
4.4
3.8
–
5.2
4.9
5.4
5.0
–
1.5
1.2
1.0
0.8
–
The description at that level read: ‘Comprehension of spoken language is limited to the
primary activities of daily living needs and
sample ideas and frequently requires repetition and/or rephrasing.’ The mean change
score was 1.0 levels and the mean discharge
score was 5.4. The description at that level
read: ‘Comprehension of spoken language is
normal for activities of daily living, but limited in complexity of form, content, or use;
self-monitoring is inconsistent.’ As these two
examples illustrate the overall data trends,
across all primary communication disorders
and service delivery settings, indicated that
speech, language, and swallowing treatment
led to greater functional independence and a
reduction in the amount of patient care
needed. Such reductions can be realized as
economies throughout the health care service
delivery (e.g. reduced levels of nursing care
required, shortened length of stays, etc.). All
the data collected from field testing of the
components to date has been incorporated
into sample ‘National Report Cards’ and is
available from ASHA upon request.
As the database grows, it will be possible to
analyze critical data subsets. For example, the
database will permit interactive analyses of
outcomes by number of treatment units, intensity of treatment, type of setting, model of
service delivery, type of provider, etc. This
information will make the database even
more valuable.
The features highlighted were those that
the project team found to be most important
in designing a treatment outcomes system.
There is always a tension between the specificity and comprehensiveness of the information collected and the amount of time it will
take clinicians to complete the necessary
forms. Clinicians found it difficult to accommodate data input demands to ongoing time
pressures of practice, and forms were continually refined to include only the minimal critical data set. Further accommodations involved the development of automated input
programs. It is clear that we must all continue
to learn how to most efficiently and effectively collect outcomes data within the context of
standard service delivery.
Two further challenges facing treatment
outcomes research are the difficulties encountered in tracking continuity of care and in adequately accounting for patient risk adjustment and co-morbidities. Although we were
able to sample patient ouctomes within different types of settings, it was not possible to
track individual patients as they moved from
one type of treatment setting to another. It
would provide important data to be able to
record admission and discharge outcomes
from each successive facility in which patients
were treated. For those health care systems
providing different levels of care within the
same administrative organization, a common
NOMS patient number could be maintained
Treatment Research in Speech,
Language and Swallowing
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Table 3. Mean admission,
change, and discharge FCM
scores from preliminary testing
of NOMS:Adult within
rehabilitation inpatient facilities
across all facilities. Similarly within school
systems a common student number could be
used as long as children maintained their
enrollment within the same school district.
NOMS project will be attempting to implement these procedures.
Another challenge is adequately adjusting
FCM scores for medical risks and co-morbidities. Although these are identified on the
NOMS forms, it is difficult to effectively
incorporate such information into outcomes
data analyses. These and other challenges,
including the long-term impacts of the functional changes noted, will need to be addressed as we continually refine the methodologies used in treatment outcomes research.
Summary and Conclusions
Intervention research is methodologically
complex, logistically difficult, and resourceintensive. In light of these features, the
amount of progress that has been made in the
last 2–3 decades in speech, language, and
swallowing treatment research is impressive.
In order to realize its full potential the next
generation of work will require increased
cooperation and collaboration among researchers and clinicians. Large data collection
networks will be necessary to explore the
types of interactive variable studies suggested
by the child language intervention literature
and to pursue treatment efficacy and treatment outcomes research on the scale needed.
In order to meet these needs, efforts will have
to be expended by organizations that can provide sufficient network infrastructure and
support such as those discussed that are being
pursued by ASHA. It will also be necessary for
researchers and clinicians to be willing to
work together within these networks in order
for their potential to be realized. If it is possible for us to do so, the next decade promises to
provide answers that are critically important
to the efficient and effective delivery of clinical practice and to the evolution of the discipline underlying that practice.
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