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On the Trail of Improved Cancer Outcomes: An Outcomes Research Example. Arthur R. Williams, PhD, MA, MPA Director, Center for Health Outcomes and Health Services R esearch. Nurse. Health Outcomes Researcher. Researcher. Health Care System. HELP!!. Outcomes Researchers. - PowerPoint PPT Presentation
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On the Trail of Improved Cancer Outcomes: An
Outcomes Research Example
Arthur R. Williams, PhD, MA, MPA
Director, Center for Health Outcomes and Health Services
Research
Outcomes Researchers
Health Outcomes Researcher
NurseResearcher
Health Care System
HELP!!
What is Outcomes Research?
“Outcomes research seeks to understand the end results of particular health care practices and interventions. End results include effects that people experience and care about, such as change in the ability to function. … By linking the care people get to the outcomes they experience, outcomes research has become the key to developing better ways to monitor and improve the quality of care. “
-- Agency for Healthcare Research and Quality, March 2000 www.ahrq.gov
Outcomes Research can be viewed as a subarea of Health Services Research. Where Health Services Research is focused “on how people get access to health care, how much care costs, and what happens to patients as a result of this care. The main goals of health services research are to identify the most effective ways to organize, manage, finance, and deliver high quality care; reduce medical errors; and improve patient safety. “
-- Agency for Healthcare Research and Quality, February 2002 www.ahrq.gov also AcademyHealth www.academyhealth.org
A Health Services Research Paradigm circa 2003
Figure 1: An Ideal Type Old-Fashion Clinical Practice Paradigm
The clinician is all heart. Intervention moves the patient from a dark and stormy night to health and happiness if successful. Note the difference, however, between output and outcomes. One can argue that it is the outcome not the output that is truly of Value for the Patient (VFP).
PHYSICIAN
PATIENT OUTPUT
e.g. TEST RESULT
OUTCOME
e.g. QUALITY OF LIFE
Figure 2: An Ideal Type Organized Clinical Practice Paradigm
The model in Figure 2 resembles Figure 1 with an injection of “management.” As a result, “dollars” or the economic costs of health services can loom large. Indeed, a strong emphasis on management can be seen by patients as attempts by providers to limit care and expenditures despite patient perceived needs. Feedback (white arrow) is primarily used as a management tool.
PHYSICIAN
PATIENT
OUTPUT
e.g. TEST
RESULT
OUTCOME
e.g.
QUALITY OF LIFE
MANAGEMENT
Figure 3: An Ideal Type Paradigm (Health Services Research) that is Value for the Patient (VFP) Focused
Comprehensive feedback occurs among patient and clinician about treatment outputs and outcomes (white arrows) and to a management which is output/outcome focused (yellow arrows). Financial considerations are important, but the patient is central. Evaluation of outcomes recognizes the importance of the family and community and that outcomes are different from outputs.
PHYSICIAN/ CLINICIANS
PATIENT
OUTPUT
e.g.TEST RESULT
OUTCOME
e.g. QUALITY OF LIFE
MANAGERS
Health Services Research contains elements of evidence based medicine, clinical epidemiology, psychology, medical sociology, organizational behavior (understudied), quality and safety analyses (industrial engineering), advanced multivariate statistics, and, especially, health economics.
Patient Shared Decision-Making
TENDENCIES IN OUTCOMES RESEARCH
1. Research generally arises from a specific clinical issue or problem .
2. Use (often) of quasi-experimental designs.
3. Use (often) of administrative or existing data sets.
4. Use of complex statistical procedures, which may be consequence of 2 and 3 .
5. Use of measures of both outputs (and process) and outcomes.
6. Use of highly multi-disciplinary teams.
Improving Cancer Outcomes Using the Therapy-Related Symptom Checklist (TRSC) for Adult Oncology Patients
Arthur R. Williams, PhD, MA, MPA
Phoebe D. Williams, PhD, RN, FAAN
TRSC Research Team*
*Team consisted of economist/statistician, nurse researcher, 6 oncology nurses, 3 physicians, computer analyst, biostatistician, nutritionist, and other clinical staff at a Cancer Center within a community hospital system in small town/rural Wisconsin.
Tendency 6: MULITIDISCIPLINARY
TEAM
Initial Reason for Study of Symptoms
(1984-1986) 3 Advanced Practice Nurses at the University of Florida believed under-documentation of patient symptoms was impeding symptom management and patient recovery.
Researched and published : 1.8 symptoms per patient documented in medical records yet patients reported 11.0 symptoms on average of concern to them. Youngblood M, Williams PD, Eyles H, Waring J, Runyon S. (1994). A comparison of two methods of assessing cancer therapy-related symptoms. Cancer Nursing; 17(1): 37-44.
Tendency 1: CLINCAL ISSUE
FOLLOW-UP: Calibration, Testing, and Development of a 25-Item Therapy-Related Symptom Checklist (TRSC) for
Adult Oncology PatientsTHERAPY-RELATED SYMPTOMS CHECKLIST (TRSC)
Name:__________________________________ Hospital #________ Date:_______ PLEASE CHECK THE PROBLEMS YOU HAVE HAD IMMEDIATELY AFTER AND SINCE YOUR LAST TREATMENT. PLEASE CIRCLE HOW SEVERE THE PROBLEM WAS ACCORDING TO THE FOLLOWING SCALE: 0 = NONE 1 = MILD 2 = MODERATE 3 = SEVERE 4 = VERY SEVERE EXAMPLE Degree of Severity Pain ................................................................................................. 0 1 2 3 4 Taste Change ................................................................................... 0 1 2 3 4 Loss of appetite ................................................................................ 0 1 2 3 4 Nausea ............................................................................................. 0 1 2 3 4 Vomiting.......................................................................................... 0 1 2 3 4 Weight loss ...................................................................................... 0 1 2 3 4 Sore mouth....................................................................................... 0 1 2 3 4 Cough .............................................................................................. 0 1 2 3 4 Sore throat ....................................................................................... 0 1 2 3 4 Difficulty swallowing....................................................................... 0 1 2 3 4 Jaw pain........................................................................................... 0 1 2 3 4 Shortness of breath ........................................................................... 0 1 2 3 4 Numbness in fingers and/or toes ....................................................... 0 1 2 3 4 Feeling sluggish ............................................................................... 0 1 2 3 4 Depression ....................................................................................... 0 1 2 3 4 Difficulty concentrating.................................................................... 0 1 2 3 4 Fever................................................................................................ 0 1 2 3 4 Bruising ........................................................................................... 0 1 2 3 4 Bleeding........................................................................................... 0 1 2 3 4 Hair loss........................................................................................... 0 1 2 3 4 Skin changes .................................................................................... 0 1 2 3 4 Soreness in vein where chemotherapy was given............................... 0 1 2 3 4 Difficulty sleeping............................................................................ 0 1 2 3 4 Pain ................................................................................................. 0 1 2 3 4 Decreased interest in sexual activity ................................................. 0 1 2 3 4 Constipation..................................................................................... 0 1 2 3 4 Other problems (please list) 0 1 2 3 4 ______________________............................................................... 0 1 2 3 4 ______________________............................................................... 0 1 2 3 4 ______________________............................................................... 0 1 2 3 4 ______________________............................................................... 0 1 2 3 4 Phoebe D. Williams, PhD ©Copyright 1995 University of Kansas Medical Center
Many publications; Some summarized in Barry MJ, Dancey JE (2005). Instruments to measure the specific health impact of surgery, radiation, and chemotherapy on cancer patients (pp.201-215). In: Lipscomb, J., Gotay CC, Snyder C (Eds.), Outcomes Assessment I n Cancer: Measures, Methods, and Applications. Cambridge University Press, London.
Objective of the Study by the Wisconsin Team: To Determine in an Outpatient Setting If:
Documentation of patient reported symptoms, management of these symptoms, and HRQOL can be improved through use of the TRSC.
H1: A treatment cohort using the TRSC at clinic visits will show a statistically significant positive increase in HRQOL-LASA compared to a treatment cohort receiving standard of care.
H2: A treatment cohort using the TRSC during clinic visits will show a statistically significant larger number of symptoms documented and managed compared to a treatment cohort receiving standard of care.
Translational Research
Quasi-Experimental Design of Study
Sequential non-equivalent cohort design: early cohort serves as study “control” for later “treatment” cohort. Ref: Happ MB, Sereika S, Garrett K, Tate J. Use of the quasi-experimental sequential cohort design in the study of patient–nurse effectiveness with assisted communication strategies (SPEACS). Contemporary Clinical Trials 2008 29:801-808.
Statistical analysis using generalized estimating equations (GEE): additional strength through use of repeated measure panel. Ref: Twisk JWR. Applied Longitudinal Data Analysis for Epidemiology: A Practical Guide. Cambridge: Cambridge University, 2003.
Tendency 2: QUASI-EXPERIMENTAL DESIGN
Tendency 4: COMPLEX STATISTICS
Demographics of Study SubjectsOf the 128 subjects on which data were collected 2 were excluded for having only one visit and 13 were not able to be staged for their cancer. Stage was considered a critical covariate in the two GEE. Exclusion of these subjects left 113 for the analysis in this paper with 696 observations. The mean number of observations per patient was 5.2. Final “Control” Group n=55 subjects; Final “Treatment” Group n=58 subjects.
No statistically significant differences between groups on: Age: Gender; Marital Status; Education; Presence of Significant Other; Stage; Diagnoses; Radiation; Chemo; Both Radio-Chemo.
Median Age = 61; Married: 79%; Education: 36% HS or Less; 47% HS+; 16% BS/BA+; Race: 96% Caucasian. Profile reflects populations in small town/rural Upper Midwest.
Results of GEE Analysis of HRQOL-LASA on Covariates
Response: HRQOL Corr: Exchangeable
Variable Name Coefficient StErr p-value
constant 16.7528 7.7564 0.031
Baseline QOL .7083 .0829 < 0.001
Treatment Group 3.3144 1.3152 0.012 .
Education -.8092 .7233 0.263
Age .0090 .0673 0.893
Male -3.2381 1.5391 0.035
Significant Other .1893 1.5507 0.903
Stage .6205 .7723 0.422
Radio -2.6490 1.5413 0.086
Chemo -3.6356 2.3372 0.120
Days from Baseline -.0166 .0109 0.129
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#observations: 583 scale parameter: 62.3707 #iterations: 4
Estimate of common correlation 0.6095
MAIN FINDING
Results of GEE Analysis of Total Symptoms on Covariates
Response: Number of Symptoms Corr: Exchangeable
Variable Name Coefficient StErr p-value
constant 2.5747 2.2991 0.263
Treatment Group 3.7597 .5939 < 0.001 .
Education -.1588 .2531 0.344
Age -.0310 .0328 0.893
Male -.7299 .6698 0.276
Significant Other .0226 .6699 0.973
Stage .7590 .3482 0.029
Radio .0767 .4155 0.853
Chemo 1.2776 .6814 0.061
Days from Baseline .0005 .0031 0.870
Days × Treatment Group -.0151 .0072 0.037
----------------------------------------------------------------------------------------------------
#observations: 696 scale parameter: 13.5982 #iterations: 5
Estimate of common correlation 0.6977
Main Finding
Important “Process” Finding
Tendency 6: MEASURES OF OUTPUTS AND OUTCOMES
RESULTS & CONCLUSIONS
Treatment group patients had a 7.2% higher population averaged covariate adjusted HRQOL than “control” patients, (3.3 more points on the HRQOL, P = .012.) 116% more covariate and non-covariate adjusted symptoms were documented and managed in the “treatment “group than in the “control” group, (6.14 symptoms versus 2.84, P < .0001). Despite low sensitivity to change, a 2.0 point mean difference improvement was found in Karnofsky scores in the “treatment “group versus the “control” group, (P < .01). The HRQOL, TRSC, and Karnofsky scores correlated r > .40.
Use of the patient-friendly TRSC by patients and clinicians improves HRQOL. Documentation and management of symptoms also are improved.
Tendency 3:
ADMINISTRATIVE DATA SETS
DISCUSSION OR POP QUIZ
Which of the tendencies, if any, of OUTCOMES RESEARCH are not illustrated in this presentation?
What in the table is not a measure of OUTCOME?
Measure Example
Mortality Infant death rate
Physiologic measures Blood pressure
Clinical events Stroke
Symptoms Difficulty breathing
Functional measures SF-36, a 36-item health survey
Patients' experiences with care Consumer Assessment of Health Plans survey
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