Single Subject Research Design (SSRD) Bill Miller, PhD, OT UBC School of Rehab Sciences VCHA OT Research Scientist SSRD Workshop 1 Objectives • • • • • Define Single Subject Research Design (SSRD) Rationale for using SSRD Describe several forms of SSRD Discuss the methods of analyses using SSRD Discuss strengths & weaknesses of SSRD SSRD Workshop 2 Continuum of Research Quasi-Experimental (Groups -no random selection) Case report Case Study (Individuals - SSRD) Experimental (RCT) Pre Scientific Scientific SSRD Workshop 3 Other Names for SSRD • • • • • • • Single case experimental design Time series design Small-N design Single system designs Within-subject comparison Idiographic research N of one trial SSRD Workshop 4 SSRD Defined SSRD involves studying a single individual or system by taking repeated measurements of 1 or more dependent variables and systematically applying & sometimes, withdrawing or varying the independent variable. (Ottenbacher, 1986; Bloom & Fischer, 1982) SSRD Workshop 5 Why Chose SSRD? • • • • • • • Demonstrates individual differences Difficulty obtaining adequate power (N) Difficulty obtaining homogeneous group SSRD is relatively easy to do Helps validate practice Demonstrate treatment (tx) effectiveness Great pilot SSRD Workshop 6 About SSRD • Collection of methods (eg; AB, ABAC) • Answers research question or tests hypothesis • Involves at least one; • Subject (individual or clinical unit/department) • Baseline or “A” Phase - series of repeated observations or measurements with no intervention • Intervention or “B” Phase - introduction of experimental variable with evaluation to see if change occurs • Dependent variable (quantifiable) • Independent variable (treatment / intervention) SSRD Workshop 7 SSRD Phases Baseline • Period of no tx - reflects natural state • Provide standard for evaluating tx effect • Measurements usually repeated until stability demonstrated • 5 or more data points SSRD Workshop 8 Sample Baseline Phases 93.5 A) 12 B) 93 10 92.5 Behaviour 8 6 4 92 91.5 91 90.5 2 90 0 1 2 3 4 5 6 89.5 1 Se s s i o ns 93 92.5 C) 93 2 3 4 5 6 D) 92 92 91 Behaviour Behaviour 91.5 91 90.5 90 90 89 89.5 88 89 88.5 87 1 2 3 4 5 SSRD Workshop 6 1 2 3 4 5 9 6 SSRD Phases Intervention Phase • Introduce tx or intervention • = independent variable • Multiple treatments are alright • Repeated measurement of dependent variable • Phase length should be approximately same as baseline SSRD Workshop 10 Dependent Variable • Variable of interest needs to be quantifiable • Does not require a standardized test • Usually frequency, duration, magnitude • i.e. episodes of self-abuse / walk time / pain intensity • Should assess reliability of variable » total % agreement » Point by point % agreement » kappa SSRD Workshop 11 Simple Design 12.5 A-B 11.5 – 1 baseline + 1 tx phase 10.5 Problems – Limited control over threats to internal validity units 9.5 8.5 7.5 Solution Replication 6.5 – Add phases – Add other tx/interventions – Add subjects 5.5 A B 4.5 1 SSRD Workshop 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Time (session) 12 Withdrawal Designs 9 A-B-A 8 • Problems 7 Units – Shows intervention leads to target behaviour (TB) – TB disappears when intervention stopped 6 5 – Unethical to withdraw tx – Reversible target behaviour 4 A B A 3 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Time (sesions) SSRD Workshop 13 21 22 23 Withdrawal Designs 70 A-B-A-B 60 - adds an extra tx phase - ↑ confidence in tx effect B A B 50 # of hits Problems - Reversible target behaviour - Unethical to withdraw tx A 40 30 20 10 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 Days SSRD Workshop 14 Multiple Treatment Designs 96 Alternating Oxygen staturation – Rapid alternation of ≥ 2 txs (or tx & placebo) – Txs alternated within same session, session to session – Advantage = quick results, baseline unnecessary – Sequence effect randomizing counterbalance – Target must be clear & happen rapidly A B 95 94 93 92 91 90 1 2 3 4 5 6 7 8 9 10 11 12 13 Daily sessions SSRD Workshop 15 14 Multiple Treatment Designs 40 Interactive (A-B-BC-B-BC) Weight (Kg) and Calories – Assess separate & joint effects of 2 or more txs – Best to replicate tx – Interactions can be tested 39 A B BC B BC 38 37 36 35 34 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 Days SSRD Workshop 16 Multiple Baseline Designs 15 Across Subjects /Conditions /Behaviors Eye Fixation 10 5 • Useful when: 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 20 – Behaviours non-replicable – Unethical to withdraw tx 15 Facial Posturing 10 • Uses basic A-B phase design – Measure baseline in all – Establish stability – Intro tx to 1st subject/condition… – Intro next tx when previous tx stabilizes 5 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 15 Diaphragmatic Breathing 10 5 0 1 2 3 4 SSRD Workshop 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 17 24 25 26 27 SSRD Analysis • Visual analysis most common • Assess trends & levels between adjacent phases – Level – refers to change in value or magnitude of dependent variable after intervention – Trend – refers to change in direction – Described as accelerating, decelerating, stable or variable • Another technique Split middle Difference – Uses celeration line to which statistical significance can be explored – Also 2 standard deviation method SSRD Workshop 18 Visual Analysis 12.5 A) Change in level 7 11.5 B) Change in trend 6 10.5 5 9.5 Units units 4 8.5 3 7.5 2 6.5 1 5.5 0 4.5 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 1 2 3 4 5 6 7 8 9 10 11 12 13 14 Time (sesion) Time (session) SSRD Workshop 19 15 Sample Visual Analyses How would you describe the following changes? 10.5 10 9 9.5 8 7 Units 6 7.5 5 4 6.5 3 2 5.5 1 0 4.5 1 1 2 3 4 5 6 7 8 9 10 11 12 13 14 2 3 4 5 6 15 7 8 9 10 11 12 13 14 15 Time (sesion) Sessions 12 12 10 10 8 8 Units Units Behaviours 8.5 6 6 4 4 2 2 0 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 1 2 Time (sesion) 3 4 5 6 7 8 9 10 11 12 13 14 15 Time (sesion) SSRD Workshop 20 Split-Middle Technique 20 A B 18 16 14 12 10 8 6 4 2 SSRD Workshop 0 1 2 3 4 5 6 7 8 9 10 11 12 13 21 14 15 16 17 18 19 20 21 22 SSRD, Case Study & Group Designs: Contrast and Comparison SSRD Case Study Between Groups Subject Own control No control Group control Hypothesis Test Generate Test Describes May control Extraneous variable Controls Design flexibility Permits change Permits change No change Differences Individual Individual Group Generalizability Limited None Similar to groups Measurement Repeated freq Through-out Few Cost Low Low Can be high Statistics Limited None Significance bt grps SSRD Workshop 22 Useful References 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. Backman CL, Harris SR. Case studies, single-subject research, and N of 1 randomized trials: comparisons and contrasts. Am J Phys Med Rehabil 1999;78:170-6. Backman CL, Harris SR, Chisholm JM, Monette AD. Single-subject research in rehabilitation: a review of studies using AB, withdrawal, multiple baseline and alternating treatments designs. Arch Phys Med Rehabil 1997;78:1145-53. Harris SR. Research techniques for the clinician. In B Connolly & P Montgomery (Eds). Therapeutic Exercise in Developmental Disabilities, Hixson, TX: Chattanooga Group. Gonnella C. Single-subject experimental paradigm as a clinical decision tool. Phys Ther 1989;69:601-9. Guyatt G, Sackett D, Taylor W, Chong J, Roberts R, Pugsley S: Determining optimal therapy: randomized trials in individual patients. N Engl J Med 1986;314:889-892 Kazidin AE. Single-case research designs. New York: Oxford University, 1982. Portney LG, Watkins MP. Single-case experimental designs. Foundations of clinical research: applications to practice (2nd ed). Appleton & Lange, 1993. Sackett DL, Haynes RB, Guyatt GH, Tugwell P: Deciding on the best therapy, in Clinical Epidemiology: A Basic Science for Clinical Medicine, ed 2. Boston, Little, Brown & Co., 1991, pp 187-248 Wolery M, Harris SR. Interpreting results of single-subject research designs. Phys Ther 1982;4:445. Zhan S, Ottenbacher KJ. Single subject research designs for disability research. Disabil Rehabil 2001;23:1-8. SSRD Workshop 23 SSRD Workshop 24