Chapter I - Purpose of Clinical Practice Guidelines for Children with Developmental Disabilities
- Purpose of Clinical Practice Guidelines for Children with Developmental Disabilities
- Scope of the Guideline
- Definition of Communication Disorders
- Definition of Other Major Terms
- The Importance of Using Scientific Evidence to Help Shape Practice
- Strength of Evidence Ratings for Guideline Recommendations
- Using Scientific Evidence as the Basis for Clinical Decision-Making
- Periodic Guideline Revisions and Versions
- Chapter I References
Purpose of Clinical Practice Guidelines for Children with Developmental Disabilities
This clinical practice guideline on communication disorders is intended to provide parents, professionals, and others with recommendations based on the best scientific evidence available about "best practices" for assessment and intervention for young children with communication disorders.
The guideline recommendations suggest "best practices", not policy or regulation
- This guideline is intended as a set of recommendations that provide guidance about "best practices." The guideline is not a required standard of practicefor the Early Intervention Program (EIP) administered by the State of New York.
- The guideline document is a tool that can be used to help providers and families make informed decisionswithin the context of the administrative system in which the care is being delivered.
- Practitioners and families are encouraged to use the information provided in this guideline recognizing that the care should always be tailored to the individual child. Not all of the recommendations will be appropriate for use in all circumstances. The decisions to adopt any particular recommendation must be made by the practitioner and the family in light of available resources and circumstances presented by individual children and their families.
Scope of the Guideline
This clinical practice guideline provides recommendations about best practices for assessment and intervention for young children with communication disorders, with a primary focus on children under 3 years of age. However, age 3 is not an absolute cut-off, and many of the recommendations in this guideline are also applicable in somewhat older children.
The primary focus of the recommendations in this guideline is:
- Communication disorders in children under three years of age
The primary focus of the guideline is children from birth to three years old. However, age three is not an absolute cut-off, since the panel felt many of the recommendations in this guideline may be applicable to somewhat older children.
- Communication disorders that
are primarily speech and language problems
While there are many aspects to communication, the primary focus of this guideline is communication problems related to speech and language.
- Communication disorders that
are not the result of hearing loss or other specific developmental
Communication disorders are sometimes the result of hearing loss or other developmental disorders. The identification of children with these problems is covered in a limited fashion in the guideline, but the in-depth assessment and intervention for these problems is not a primary focus of the guideline.
Definition of Communication Disorders
The guideline panel agreed on an operational definition of communication disorders for use in this guideline. However, before providing the operational definition as used in this guideline, it is helpful to review a generally accepted standard definition of communication disorder.
As defined by the American Speech-Language-Hearing Association (ASHA), a communication disorder is:
"An impairment in the ability to receive, send, process, and comprehend concepts or verbal, nonverbal and graphic symbol systems. A communication disorder may be evident in the processes of hearing, language, and/or speech. A communication disorder may range in severity from mild to profound. It may be developmental or acquired. Individuals may demonstrate one or any combination of the three aspects of communication disorders. A communication disorder may result in a primary disability or it may be secondary to other disabilities" (ASHA, 1993).
How the term "communication disorders" is used in this guideline
The ASHA definition above encompasses children with a delay or deviation in speech, language, and/or hearing. In this guideline, the term "communication disorders" is used to refer primarily to speech and language problems rather than hearing problems. Although hearing disorders are an important type of communication disorder in young children, assessment and intervention for hearing problems is not a primary focus of this guideline.
In the literature on communication disorders in young children, varying definitions are sometimes used for the terms "disorder" and "delay," as they refer to communication problems. A variety of different diagnostic terms and labels are also used to describe specific communication problems in young children. At the current time, there is not a standard definition of these various terms used by all professionals dealing with young children. For this reason, these terms are operationally defined for use in this guideline as follows:
- Communication disorderas used in this guideline refers to either a significant delay or an abnormality in functional communication for a child. The term "communication disorder" (or "communication problem") as used in the guideline is defined broadly to include all types of speech / language delays, disorders, and disabilities, and other functional communication problems for a child.
- Communication delay,when used in this guideline, refers more specifically to a level of functional communication that is significantly below the expected or typical levels based on a child's age, and refers primarily to speech / language delay.
Definition of Other Major Terms
Definitions are given below for some major terms as they are used in this guideline.
|Assessment||The entire process of evaluating the child, including the activities and tools used to measure level of functioning, establish eligibility for services, determine a diagnosis, plan intervention, and measure treatment outcomes.|
|Family||The child's primary caregivers, which might include one or both parents, siblings, grandparents, foster care parents, or others usually in the child's home environment(s).|
|Parents||The primary caregiver(s) or other person(s) who has (have) significant responsibility for the welfare of the child.|
|Professional||Any provider of professional services who is qualified to provide the intended service. Qualifications generally include training, experience, licensure, and/or other state requirements. The term is not intended to imply any specific professional degree or qualifications other than appropriate training and credentials. (It is beyond the scope of this guideline to address professional practice issues.)|
|Screening||May be used in the early stages of the assessment process to identify children who need more in-depth evaluation. Screening may include parent interviews or written questionnaires, observation of the child, or use of specific screening tests.|
|Target Population||A study group selected according to specific characteristics. For this guideline, the target population is children with possible communication disorders from birth to age 3 years. Throughout this document, the term young children is used to describe this target age group.|
|Young Children||Term used in this guideline to describe the target age group (children from birth to age 3 years.) Although children from birth to age 3 is the intended focus of the guideline, the term young children may also include somewhat older children.|
The Importance of Using Scientific Evidence to Help Shape Practice
Every professional discipline today is being called upon to document its effectiveness. Current questions often asked of professionals are:
- "How do we know if current professional practices are effective in bringing about the desired outcomes?"
- "Are there other approaches, or modifications of existing approaches, that might produce better outcomes or similar outcomes at less cost?"
The difficulty in answering these questions is that many times the methods used in current professional practice have not been studied extensively or rigorously.
Evidence-based clinical practice guidelines are intended to help professionals, parents, and others learn what scientific evidence exists about the effectiveness of specific clinical methods. This information can be used as the basis for informed decisions. This guideline represents the panel's concerted attempt to interpret the available scientific evidence in a systematic and unbiased fashion and to use this as the basis for developing guideline recommendations. It is hoped that, by using this process, the guideline provides a set of recommendations that reflects current best practices and will lead to optimal outcomes for children with developmental problems.
Strength of Evidence Ratings for Guideline Recommendations
Each of the guideline recommendations in Chapters III and IV is followed by a "strength of evidence" rating designated by the letter [A], [B], [C], [D1], or [D2] in brackets immediately after the recommendation. These strength of evidence ratings indicate the amount, general quality, and clinical applicability (to the guideline topic) of scientific evidence used as the basis for each guideline recommendation.
|Evidence Ratings: [A] = Strong [B] = Moderate [C] = Limited [D1] = No evidence meeting criteria [D2] = Literature not reviewed|
[A] = Strong evidence is defined as evidence from two or more studies that met criteria for adequate evidence about efficacy and had at least moderate applicability to the topic, and where the evidence consistently and strongly supports the recommendation.
[B] = Moderate evidence is defined as evidence from at least one study that met criteria for adequate evidence about efficacy and had at least moderate applicability to the topic, and where the evidence supports the recommendation.
[C] = Limited evidence is defined as evidence from at least one study that met criteria for adequate evidence about efficacy and had at least minimally acceptable applicability to the topic, and where the evidence supports the recommendation.
[D] = Panel consensus opinion (either [D1] or [D2] below):
[D1] = Panel consensus opinion based on information not meeting criteria for adequate evidence about efficacy, on topics where a systematic review of the literature was done.
[D2] = Panel consensus opinion on topics where a systematic literature review was not done.
The strength of evidence rating does not reflect the importance of the recommendation or its direction.
The strength of evidence rating does not indicate whether the recommendation is for or against use of a method. For example:
- If there was strong evidence that an intervention is effective, a recommendation for use of the method would have an <[A] evidence rating.
- If there was strong evidence that an intervention is not effective, recommendation against use of the method would also have an <[A] evidence rating.
- If a systematic literature review found no evidence about the efficacy of a specific clinical method, the recommendation either for or against use of this method would have a < [D1] evidence rating to indicate this was based on panel opinion.
- If a systematic literature review was not done for a specific method, the recommendation either for or against the use of that method would have a <[D2] evidence rating to indicate this was based on panel opinion.
Using Scientific Evidence as the Basis for Clinical Decision-Making
In developing evidence-based clinical practice guidelines, the process of reviewing the scientific literature to find evidence-based answers to specific clinical questions is challenging. Many times the specific clinical issue of interest may not have been studied extensively in well-designed studies of the type that can adequately determine if a clinical method is effective. At other times, even when well-designed studies have been done on a particular clinical topic, the study findings themselves seldom present totally straightforward and unambiguous answers to the clinical questions of interest.
Careful analysis of the studies and considerable judgment are always needed when using the findings of research studies to help in making informed clinical decisions and developing clinical practice guidelines. For most clinical topics, it is exceptional to find studies that evaluate exactly the clinical situations and types of subjects that are of interest. Therefore, it is almost always necessary to generalize to some extent in terms of the subject characteristics (such as age or IQ) and the clinical setting or the type of assessment or intervention method used. The research studies reviewed for this guideline were no exception.
In using research evidence to help make clinical decisions, the two primary considerations are the quality of the evidence and its clinical applicability to the question of interest.
Primary Considerations in Using Research Evidence
- The quality of the study is primarily related to the study design and controls for bias; the higher the quality of the study, the more confidence there is that the findings of the study are valid. Confidence in the study findings becomes even greater when multiple well-designed studies done by independent researchers find similar results.
- The clinical applicability of a study is the extent to which the study's results would also be expected to occur in the particular clinical situation of interest. The applicability of a study's findings is considered to be greater when the subject characteristics, clinical methods, and clinical setting are similar to the study and clinical situation of interest.
The overall usefulness of a study's findings to clinical decision-making relates both to confidence in the results (based on the quality and amount of scientific evidence) and the similarity of the study's subjects, clinical methods, and setting to the question of interest (that is, its applicability).
Considerations about quality of studies
The considerations about using scientific evidence as the basis for clinical decisions apply to all the recommendations in this guideline. For some of the clinical questions of interest, several studies were found that met criteria for adequate evidence about efficacy. For other questions of interest, few or no studies were found that met such criteria.
There are also numerous articles in the scientific literature that did not meet criteria for adequate evidence about efficacy, yet still contained valuable information that may be useful in clinical practice. These articles include case reports, case series (sometimes using pre and post-test designs), and other descriptive studies, as well as articles that primarily discuss theory or opinion.
Relatively rigorous criteria were used for selecting studies that would provide adequate evidence about efficacy. The findings of these studies were used as the primary basis for developing guideline recommendations. In many cases, information from the articles and studies not meeting these evidence criteria was also reviewed by the panel, but information from these sources was not considered evidence about efficacy and was not given as much weight in making guideline recommendations.
Considerations about applicability of studies
Of particular concern for this guideline was finding high-quality scientific studies that focused on children under the age of 3 years. For some topics, studies were found that evaluated only children within the guideline's target population (children from birth to 3 years of age), but for other topics, the only studies found evaluated groups that included somewhat older children (over age 3).
As noted above, the inclusion of children over age 3 does not affect the quality of the study or bias the results, but it may make the study's findings somewhat less applicable to the guideline topic. Ratings of applicability for this guideline are described in Appendix A, Table A-6.
Applicability was taken into account when making guideline recommendations and more weight was given to findings from high-quality studies that focused on children under 3 years old. However, when there were few good studies found that focused on children in the target age group, then the panel thought it important to generalize from evidence found in good studies of somewhat older children.
Judging the quality and applicability of the evidence when making guideline recommendations
Given the considerations above, the panel needed to carefully evaluate the quality and applicability of the scientific evidence that was used as the basis for these guideline recommendations. Similar limitations and considerations apply to all evidence-based practice guidelines. The strength of evidence ratings are a reflection of both the amount and quality of the scientific evidence found and its applicability to the guideline topic.
Additional information about reviewing and rating the evidence used to develop the guideline recommendations can be found in the methodology tables in Appendix A.
Periodic Guideline Revisions
It is intended that this DOH Clinical Practice Guideline for developmental disabilities in children from birth to age 3 be a dynamic document that is updated periodically as new scientific information becomes available. This guideline reflects the state of knowledge at the time of publication, but, given the inevitable evolution of scientific information and technology, it is the intention of the DOH that periodic review, updating, and revision will be incorporated into an ongoing guideline development process.
There are three versions of this clinical practice guideline published by the Department of Health. All versions of the guideline contain the same basic recommendations specific to the assessment and intervention methods evaluated by the panel, but with different levels of detail describing the methods and the evidence that supports the recommendations. The three versions are:
The Clinical Practice Guideline:
Report of the Recommendations
- full text of all the recommendations
- background information
- summary of the supporting evidence
Quick Reference Guide
- summary of major recommendations
- summary of background information
Guideline Technical Report
- full text of all the recommendations
- background information
- a full report of the research process and the evidence reviewed
Background on communication disorders
- American Speech-Language-Hearing Association. Definition of communication disorders and variations. ASHA. 1993, 35 (Supplement c10): 40-41.
References on methodology for guideline development
- Bigos S, Bowyer O, Braen G, Brown K, Deyo R, Haldeman S, Hart JL, Johnson EW, Keller R, Kido D, Liang MH, Nelson RM, Nordin M, Owen BD, Pope MH, Schwartz RK, Stewart DH, Susman J, Triano JJ, Tripp LC, Turk DC, Watts C, Weinstein JN. Clinical Practice Guideline No. 14: Acute Low Back Problems in Adults. Rockville, MD: US Department of Health and Human Services, 1994. (AHCPR publication no. 95-0642).
- Chalmers TC, Smith H Jr., Blackburn B. A method for assessing the quality of a randomized control trial. Controlled Clinical Trials. 1981, 2: 31-49.
- Eddy DM, Hasselblad V. Analyzing evidence by the confidence and profile method. In Clinical Practice Guideline Development: Methodology Perspectives. McCormick KA, Moore SR and Siegel RA (eds.) Rockville, MD: Agency for Health Care Policy and Research, Public Health Service, US Department of Health and Human Services, 1994. (AHCPR Publication No. 95-0009)
- Holland JP. Development of a clinical practice guideline for acute low back pain. Current Opinion in Orthopedics. 1995, 6: 63-69.
- Institute of Medicine, Committee on Clinical Practice Guidelines. Guidelines for Clinical Practice Guidelines: From Development to Use. Field MJ, Lohr KN (eds.) Washington, DC: National Academy Press, 1992.
- Powe NR, Turner JA, Maklan CW, Ersek RN. Alternative methods for formal literature review and meta-analysis in AHCPR patient outcomes research teams. Medical Care 1994, 32: 22-37.
- Sackett DL, Haynes RB, Guyatt GH, Tugwell P. Clinical Epidemiology: A Basic Science for Clinical Medicine, 2nd edition. Boston, MA: Little, Brown, 1991.
- Schriger DL. Training panels in methodology. In Clinical Practice Guideline Development: Methodology Perspectives. McCormick KA, Moore SR, Siegel RA (eds.) Rockville, MD: Agency for Health Care Policy and Research, Public Health Service, US Department of Health and Human Services, 1994. (AHCPR Publication No. 95-0009)
- Shaughnessy JJ, Zechmeister EB. Single case research designs. In Research Methods in Psychology, 4th edition. New York, NY: McGraw Hill, 1997; p. 305-335.
- Woolf SH. AHCPR Interim Manual for Clinical Practice Guideline Development. Rockville, MD: Agency for Health Care Policy and Research, Public Health Service, US Department of Health and Human Services, 1991. (AHCPR Publication No. 91-0018)
- Woolf SH. An organized analytic framework for practice guideline development: using the analytic logic as a guide for reviewing evidence, developing recommendations, and explaining the rationale. In Clinical Practice Guideline Development: Methodology Perspectives. McCormick KA, Moore SR, Siegel RA (eds.) Rockville, MD: Agency for Health Care Policy and Research, Public Health Service, US Department of Health and Human Services, 1994. (AHCPR Publication No. 95-0009)