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ORIGINAL CONTRIBUTION |
Address correspondence to Sandra L. Sleszynski, DO, Crossroads Premiere Health Care, SC, 1010 35th St, Kenosha, WI 53140.E-mail: sandrasleszynski{at}crossroadsphc.com
The authors validate the Outpatient Osteopathic SOS (Single Organ System)
Musculoskeletal Exam Form (SOS MSEF), a 1-page form contained within the
4-page Outpatient Osteopathic Single Organ System Musculoskeletal Exam Form
Series (SOS-FS). Handwritten physician progress notes (PPNs) in the medical
record (considered to be the "gold standard" for clinical records)
were compared with information placed on the SOS MSEF for the same patient
encounter. Data recorded by 14 trained and certified investigators on the
standardized SOS MSEFwhich was designed for use with the previously
validated Outpatient Osteopathic SOAP (Subjective, Objective, Assessment,
Plan) Note Form (SNF)was compared with data recorded by the same
investigators in PPNs. The authors compared the accuracy and efficiency of
physicians recording musculoskeletal information in these two formats for 165
patient encounters. Descriptive statistics and t tests were used to compare
data recorded after patient encounters. Ninety-seven variables input from the
PPNs or SOS MSEFs were significantly different at the P
.05 level,
whereas 38 variables were not. Insufficient data was recorded for a
determination of significance in 3 variables. For 121 variables, more data
were recorded using the SOS MSEFs than PPNs; for 84 variables, the amount of
data recorded exceeded twice that recorded using PPNs. For 10 variables, more
data were recorded in PPNs; however, these differences were not significant.
The authors conclude that the SOS MSEF is superior to PPNs for recording
patient-encounter data in the osteopathic care setting. Moreover, they argue
that the use of the validated SOS MSEF nationwide would ensure that
osteopathic physicians would be recording data in a similar manner for uniform
insurance claim coding, easy tracking of physicians-in-training and patient
outcomes, and data collection for future research.
Although there have been attempts to present a standardized format for osteopathic musculoskeletal examinations,6 and standardization for research protocols has been discussed in various forums,7 most of these proposals and discussions have been attempts to provide comprehensive guidelines for documenting osteopathic diagnostic methods for somatic dysfunctions and are too cumbersome to be practical for outcomes research that involves large groups of geographically diverse osteopathic physicians.
Over the past several years, there has been an increased emphasis on outcome measures in the practice of medicine.1,4 Medical outcomes research investigates how coded medical procedures8 used in the care and treatment of patients diagnosed with given disorders or diseases affect the health status of those patients. This result-based research does not investigate mechanisms or causes of change in these outcomes; it is concerned only with the end result on the designated objective.
Outcomes research may include physical data, patient psychological data, patient satisfaction measures, patient quality of life and function evaluations, health care costs, or a combination of these factors. With a new and growing demand for outcomes-based research within the osteopathic profession,9,10 there is an increasingly urgent need for a standardized reporting format that addresses the incidence, severity, treatment of, and patient outcomes related to somatic dysfunction. If the osteopathic profession is to survive and remain financially viable to its practitioners in an increasingly competitive climate of health care provision, it must provide statistics on the diseases and disorders it treats and illustrate how these conditions are distributed within the patient population it serves. The profession must also provide new research based on these patient outcomes and the use of concepts that are central to osteopathic principles and practice (OPP).
The Outpatient Osteopathic SOS (Single Organ System) Musculoskeletal Exam Form (SOS MSEF) is a 1-page form contained within the 4-page Outpatient Osteopathic Single Organ System Musculoskeletal Exam Form Series (SOS-FS) (Figures 1 and 2,2,2). The SOS MSEF (Figure 2, page 2 of 3) is an outcomes instrument and, as considered in this study, is anticipated for wide use within the osteopathic profession. It is hoped that osteopathic physicians will find the SOS MSEF useful for documenting initial and comprehensive musculoskeletal evaluations in the outpatient setting.
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The osteopathic investigators who previously validated the Outpatient Osteopathic SOAP (Subjective, Objective, Assessment, Plan) Note Form (SNF)11 found this form to be easy to use for accurately recording work performed and outpatient treatments delivered. Further, regular use of the SNF significantly increased physician reimbursement claims without requiring a change in physicians' practice methods.
The purpose of the current study was to validate the SOS MSEF as an instrument for accurately and thoroughly recording patient-encounter data in a standardized format. Medical record data recorded in physician progress notes (PPNs) and on the SOS MSEF were compared as to quality and quantity of data recorded.
| Materials and Methods |
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The SOS MSEF also includes areas for physicians to note in Yes/No format if the results from patient examination revealed that the following appeared to be within normal range: General Appearance, Cardiovascular [observation and palpation], and Lymphatics, as well as Neurologic and Psychiatric [aspects]. There are also specific sections of the SOS MSEF devoted to the appearance of the patient's Skin, Reflexes, and Motor activity. As noted, these items are included for coding purposes and are listed in checkbox form for physicians' ease of use.
Investigators
We sought and received institutional review board approval from each of the
six agencies with oversight at the colleges of osteopathic medicine and
hospitals where our investigators were employed. We also received
institutional review board approval at our primary study site, the
Biotechnical Institute's Human Subjects Committee at the University of
Wisconsin at Parkside in Kenosha. Fourteen of the 15 investigators who were
trained and certified in the use of the trial SOS MSEFs were asked to submit
cases. One investigator dropped out of the validation phase of the project
because of personal reasons. Seven investigators were osteopathic physicians
(3 family practice physicians and 4 OMT specialists), 5 were resident
physicians (3 osteopathic manipulative medicine plus-one residents, 1
osteopathic medicine resident, and 1 family practice resident), and 2 were
predoctoral osteopathic medicine undergraduate fellows.
Each investigator filled out a demographic information form. These forms requested information about investigators' professional status and educational backgrounds as well as personal information (Table 1). As noted, some investigators did not answer all the questions provided on the form.
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Validation Protocol
Investigators were randomly divided into two groups. The first group
collected and documented patient information in the PPN format they were
accustomed to using and were thenwithin 24 hours of documenting those
recordsasked to transcribe the data from their PPNs to a trial SOS
MSEF.
The second group was asked to record data in the opposite order. Investigators in the second group began by documenting patient information on the trial SOS MSEFs and then, within 24 hours, transcribed the records onto the PPN format they were accustomed to using.
Investigators did not use the form as published and presented in this paper. They used a preliminary, "trial" form, which was later modified in response to volunteer investigators' suggestions as a result of working with the trial SOS MSEFs in the clinical setting, and making suggestions to study investigators during handwritten exit surveys and in a group exit interview.
Data from 165 sequential patient encounters were collected. To preserve patients' privacy, their names were removed from the PPN and 3-digit identification numbers were assigned instead. The same identification number was placed on the corresponding trial SOS MSEF. At the completion of this phase, copies of the PPNs along with the completed trial SOS MSEFs were sent to the data collection center in Kenosha, Wisc.
During the 5-month study period from November 2000 to March 2001, all patients who were new, had not had a comprehensive musculoskeletal examination in the previous 12 months, or were required to have an in-depth examination were included in the study without regard to sex, age, race, or diagnosis. These inclusive criteria allowed for testing of the trial SOS MSEF for all patient complaintsnot just those of musculoskeletal originand were essential for validating the trial SOS MSEF for use by family practice physicians and specialists within the osteopathic profession. The repetition of filling out the trial SOS MSEF provided insight into physician compliance with the two-group protocol.
At the data collection center, we hired a data coordinator and trained him to transcribe the information from the original PPN onto a color-coded SOS MSEF so that the forms could be compared easily.11 The data coordinator was a clinical technician with medical training and 6 years of experience and was familiar with all medical shorthand, terminology, and jargon used by clinicians when writing PPNs.
During the transcription of data from the PPNs to the color-coded SOS MSEFs, the data coordinator compiled notes for discussion with the current study's principal investigator (S.L.S.) and coauthors when needed. All coordinator-compiled notes and questions were addressed in a timely fashion to ensure that there were no transcription errors. The data coordinator then entered the data in a useable format for the statistician (T.G.). In addition, the principal investigator (S.L.S.) conducted random verification of the transcription process and the data entry to verify the accuracy of the transcriptions. A total of 330 cases were entered, two for each of the 165 patient encountersone that was transcribed from the PPNs onto trial SOS MSEFs, and the other that was transcribed from the trial SOS MSEFs onto PPNs.
At the end of the study, each investigator completed a written, 16-question exit survey (Figure 3) and attended a group exit interview.
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The exit survey queried volunteer investigators on the usefulness of the training they received in the use of the trial SOS MSEF, the clarity of the Usage Guide that was to accompany the SOS-FS, their general opinions on the trial SOS MSEF, and the impact such an instrument might have on the practice of osteopathic medicine in the United States. Issues regarding the feasibility of using a validated SOS MSEF nationwide, physician satisfaction, benefits and drawbacks of using the proposed SOS MSEF, ease of use and efficacy, and other comments regarding use of the proposed SOS MSEF were obtained through the handwritten surveys and were later discussed in the exit interview.
Many of the issues uncovered during the exit surveys and interview were determined by the current study's investigators to be as important as establishing the validity of the instrument if the proposed SOS MSEF was to be used successfully in collecting and analyzing data from many osteopathic physicians' offices for large-scale osteopathic research studies.
As noted, information obtained from volunteer investigators during the group exit interview was essential in the development of the final, published version of the SOS MSEF and the SOS-FS's accompanying Usage Guide. Changes that were added to the published SOS MSEF include the addition of standard Motor testing and individual TART (tissue texture changes, asymmetry, range of motion, tenderness) designations for each region of Somatic Dysfunction and Other Systems (Figure 2, page 2 of 3). The section allotted to recording the condition of patients' Skin was reformatted (Figure 2, page 2 of 3). Whether a somatic dysfunction region was treated with OMT (Yes/No checkboxes), which osteopathic manipulative technique(s) was (were) used (ie, Treatment Method), and the patient's Response to treatment were moved to the Outpatient Osteopathic Assessment and Plan Form portion of the SOS-FS (Figure 2, page 3 of 3). Specific cranial dysfunction findings were removed. None of these format changes affected the validity of the SOS MSEF.
Data Reduction and Statistics
Descriptive statistics were used in combination with cross-tabulation using
Pearson's
2 test, allowing us to determine the significance of
differences between the two groups of volunteer investigators (handwritten
PPNs first vs trial SOS MSEFs first). Both methods were used to evaluate the
138 variables derived from the trial SOS MSEF.
The combination of results from these two statistical tests provided an estimate of variability in areas of the trial SOS MSEF that called for scaling of the data collected. These tests also determined the accuracy of the transcription of data performed by each group of investigators. The chosen power of 150 forms was based on experience obtained by investigators that had worked on the SNF study.11
We believe 150 forms provide a reasonable representative sample of practicing osteopathic physicians. Further, in considering cost-containment measures for this study, we decided to restrict the number of data points gathered for evaluation.
Since the study was essentially a null-hypothesis study, a determination of statistical power was essential. Following the statistical analysis, the statistical power determination of Dupont and Plummer13 was used to determine whether the number of cases (ie, 150) was sufficiently large to provide a statistical power of 80% in those instances where no significant differences were found between the two groups. Consensus data and averages were used to evaluate the exit surveys.
In addition to the 138 variables required for the trial SOS MSEF, the required data fields also included case numbers (eg, 1330), investigator and patient identification codes, and SOS MSEF and PPN form codes. Three variables (ie, Pulse regularity, blood pressure [standing or lying]) contained no data and were not included among the total of 135 variables analyzed.
| Results |
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The trial SOS MSEFs and PPNs were compared by tabulating missing data,
cross-tabulating the two data sets, and performing chi-square
(
2) tests for equality between the two groups. The outputs
were of three types:
.05 level (97
variables),
.05 level (38
variables), or
For 83 form elements, the P value was less than .001. For 125
elements, more data were recorded using the trial SOS MSEFs than the PPNs. For
84 form elements, the amount of data recorded using the trial SOS MSEFs was
twice that recorded in the PPNs (ie, a 100% enhancement in the capture of
information). For 94 elements, information capture was greater than 50%. For
10 variables (Table
2), more data were recorded in the PPNsbut in no
instance were these differences significant at the P
.05
level.
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Exit Survey and Group Exit Interview
From the exit survey, we received many comments from investigators
regarding the training they received on the use of the SOS MSEF, the
usefulness of the SOS-FS Usage Guide, and potential for impact on the practice
of osteopathic medicine. We also received suggestions for how the trial SOS
MSEF should be revised prior to publication and wide dissemination of a final
version.
Nine of the 14 investigators took part in this phase of the study. All nine investigators reported receiving adequate training on the study's protocol and use of the SOS MSEF in the clinical setting. All nine further noted that contact personnel were helpful. Eight of 9 said the SOS-FS Usage Guide was helpful and easy to use.
It was found from practice-impact questions that 7 of 9 said the SOS MSEF was easy to fill out, 8 of 9 investigators said it was useful and helpful in the clinical setting, alerting them to information they would otherwise have omitted from their usual PPNs.
On average, it took investigators 7.27 minutes to fill out the SOS MSEF. Previously, it took these same investigators an average of 11.33 minutes to document a comprehensive musculoskeletal examination adequately in standard handwritten PPNs.
Eight of 9 participants said that they would use the SOS MSEF for recording comprehensive osteopathic musculoskeletal examinations in their outpatient practices.
The rest of the questions on the survey asked investigators for written comments regarding how we might improve or change the SOS MSEF. We requested that investigators provide a list of additions and deletions for form variables.
As noted elsewhere, we used suggestions that arose from investigators' exit surveys and the group exit interview to create the final, published version of the SOS MSEF.
| Discussion |
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Although there were essentially no errors when comparing data recorded in the trial SOS MSEFs with data recorded in the PPNs, considerably greater information was recorded in the trial SOS MSEFs than in handwritten PPNs in less time and with more ease.
Of the 135 form elements (ie, statistical variables) analyzed, there were only 10 instances in which greater amounts of data were recorded by investigators in their handwritten PPNs relative to the data they recorded on the trial SOS MSEFs. These 10 instances constitute failures of the SOS MSEF to capture data recorded in the PPNs. Most of these count differences, however, were less than 6 per 165 cases (7 variables, P < .115). In one instance, sidebending/rotation of the cranium, was there was a borderline significant difference (P < .114). As noted, this item, which appeared only on the trial SOS MSEF, was dropped from the final, published version of the SOS MSEF at the suggestion of investigators.
What can be interpreted from the data is that the SOS MSEF is just as accurate as the PPNs in gathering patient information and is superior to the PPNs in the quantity of data gathered.
For the set of information labeled Somatic Dysfunction and Other Systems at the bottom of the SOS MSEF (ie, Head and Face [ICD code8 739.0] through Lower Extremity L[eft] [ICD code 739.6]), there is no difference between data recorded on the SOS MSEFs and PPNs (P = 4). In other words, the probabilityalthough not at a level that is significantly different between the two formatsis not equivalent either, possibly indicating that documenting somatic dysfunction in a musculoskeletal table is common practice for osteopathic physicians and leads to equivalent records no matter what documentation format is used. The space provided for all other sections in the two-page table (eg, on the SOS MSEF, Severity; on the Outpatient Osteopathic Assessment and Plan Form, OMT [Yes/No checkboxes], Treatment Method, and [patient] Response to OMT) was new to most of the investigators. In fact, many investigators noted in the exit interview that these portions of the trial SOS MSEF reminded them to document information that they otherwise might have not noted in their standard handwritten PPNs.
Single Organ System (SOS) and SOAP Note Form Series
The Louisa Burns Osteopathic Research Committee of the American Academy of
Osteopathy developed and validated two structured medical record formats for
clinical research and educational purposes. Both formats are complete
record-keeping systems.
The SOS-FS consists of four pages. The first page is a detailed Outpatient Health Summary form and is used for noting initial and on-going history (Figure 1). The second page is the Outpatient Osteopathic SOS History/Exam Form (Figure 2, page 1 of 3) and is used to document the chief complaint; to record a detailed review of systems; and to note personal past medical, family, and social history as well as the physician's objective findings. The third page is the Outpatient Osteopathic SOS Musculoskeletal Exam Form (Figure 2, page 2 of 3) and contains a musculoskeletal examination table and additional objective examination items. The fourth and last page in the SOS-FS is the Outpatient Osteopathic Assessment and Plan Form (Figure 2, page 3 of 3) and contains prioritized diagnoses, treatment recommendations, and treatment(s) given.
Through the exit surveys and interview, we determined that the four-page SOS-FS could be used for the initial history and physical examination of new patients and for returning patients who require detailed or comprehensive musculoskeletal examinations.
The original SNF11 was revised in 2002 to pattern itself after the SOS-FS and is now called the Outpatient Osteopathic SOAP Note Form Series (SNFS). The SNFS is best used for follow-up visits as well as documenting initial visits for new patients in a primary care or nonosteopathic manipulative medicine specialty practice.
The SNFS and SOS-FS can be used together or separately in an outpatient office in any way a practitioner chooses. Both of these form series can be obtained from the copyright holder, the American Academy of Osteopathy (see http://www.academyofosteopathy.org/ for more information).
The validated SOS-FS could prove a valuable tool for a vertically integrated, seamless osteopathic curriculum, in a manner similar to those of the SNFS and the Osteopathic Musculoskeletal Examination of the Hospitalized Patient Form (OMEHP), the latter being currently recommended for use by the American Osteopathic Association's Healthcare Facilities Accreditation Program, the American Association of Colleges of Osteopathic Medicine, and the American Academy of Osteopathy.
The SOS-FS could also facilitate the solution of curricular challenges at the colleges of osteopathic medicine, namely the teaching of basic, unique osteopathic documentation. With the approval of institutional faculties, the SOS-FS could be introduced to osteopathic students during the second year of medical school, or it could be incorporated into the current recommendations for Research-in-OPTI (osteopathic postdoctoral training institutions) programs. Others may find the SOS-FS valuable as a standardized reporting tool for use by osteopathic physicians at regional, state, and national levels to collect research data.
Financial Implications
The potential financial advantages to a family practice physician using the
new SNFS and SOS-FS are illustrated in
Table 3, where we
present a comparison of billing results for an osteopathic physician in a solo
private practice. In this table, the osteopathic physician used the original
SNF alone from February 2001 through January 2002. From February 2002 through
January 2003, however, she used the new SNFS and SOS-FS. For the year
reported, the physician's documented level 2 visits decreased significantly,
from 63% of total billable patient visits to 6%, while her documented level 3
visits doubled, from 28% to 58% of total visits. The level 4 visits this
osteopathic physician conducted and documented more than tripled, from 7% up
to 33% of all billable patient visits. The financial implications regarding
coding and the billable visit level are obvious. This physician in solo
practice saw a total "annual" increase in billable insurance
claims of $18,112.
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A valid, standardized and easily incorporated osteopathic-outcomes examination form is essential for documenting changes patients experience in their symptoms associated with somatic dysfunction as a result of OMT. Standardized documentation of the treatment modalities used by osteopathic physicians is vital to the osteopathic profession for explaining OPP to the medical, legal, and health insurance communities. It is only through valid and consistent documentation that we can hope to obtain outcomes information that supports our profession's teachings.
Wide adoption of the SOS-FS, like the SNFS, is a necessary step toward specific outcomes studies that involve the treatment and care of patients with somatic dysfunction as delivered by osteopathic physicians.
The long-term objective for our studies is to provide evidence for the feasibility of using a standardized record,14 with the ultimate goal of building a National Osteopathic Clinical Database.
The two series of forms provide for the efficient collection of quality standardized research data that could lead to nation-wide data analysis and more formalized reporting. Data housed within a National Osteopathic Clinical Database could then be mined by researchers to strengthen the understanding of osteopathic manipulative medicine by the public, allied health professionals, insurance companies, and the legal system. Extensive use of the SOS-FS and the SNFS would permit internal comparison studies between osteopathic physicians who use OMT and those who do not. Use of the SOS-FS could allow OPTIs to track more easily patient encounters, diagnoses made, and the procedures performed by resident physicians.
Looking Forward: The Future of the SOS Form Series and the SOAP Note Form Series
During the group exit interview, we determined physician compliance and
performance over time, as well as the difficulties and obstacles investigators
encountered while using the SOS MSEF. Outcomes research requires the
establishment of a methodsuch as the use of a validated standardized
SOS-FSfor providing reliable, efficient, and accurate recording of
examination data and changes in a patient's health status.
Once a basic instrument is selected, an outcomes study can be designed to assess the cost-effectiveness of available treatment modalities, the billing practices of osteopathic physicians who treat their patients using OMT, the effectiveness of OPP and OMT in the primary care setting, the efficacy of OMT for improving the health of underserved populations, and the value of OMT in the field of preventive medicine.
Future studies will be outcomes-based and will report on the use of the SOS-FS when used to study the effectiveness of OMT. Topics will note changes in the natural history of somatic dysfunction, autonomic and visceral correlations of somatic dysfunction with disease entities, and changes in health status brought about through the use of OPP in a physician's treatment program for patient care.
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| Acknowledgment |
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The authors also thank David George; Todd Michael Larsen; Bethany Mondrawickas; Scott T. Stoll, DO, PhD; and David P. Yens, PhD.
| Footnotes |
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From the Chicago College of Osteopathic Medicine at Midwestern University in Downers Grove, Ill (Sleszynski, Glonek) and the Kirksville College of Osteopathic Medicine in Mo (Kuchera).
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