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Address correspondence to Sandra L. Sleszynski, DO, Crossroads Premiere Health Care, SC, 3200 Sheridan Rd, Ste 104, Kenosha, WI 53140-1921.E-mail: sandrasleszynski{at}crossroadsphc.com.

One of the persistent challenges facing the osteopathic medical profession has been the lack of a reliable, easy-to-use, validated system for recording, collecting, and evaluating clinical findings in a format that is suitable for long-term data collection. As a result of the recent emphasis on outcomes-based research in the field of medicine, the creation and use of a standardized tool for the osteopathic profession has been pursued with increased urgency. In this study, the authors used participant-completed and previously validated Outpatient Osteopathic SOAP (Subjective, Objective, Assessment, Plan) Note Forms (SNFs) and Outpatient Osteopathic SOAP (Subjective, Objective, Assessment, Plan) Note – Follow-up Forms to obtain answers to 17 outcomes-based questions that the profession must address to meet the new challenges and demands of outcomes-based research. A consortium of 10 osteopathic physicians and 196 osteopathic residents and undergraduate fellows submitted a total of 3908 patient SNFs for analysis. Answers to these 17 questions were computed using appropriate statistical determinants (eg, frequencies, correlations). Retrospective analysis indicated that, in addition to the outcomes addressed in this study, use of the SNF could be extended to the following functions: pre- and postdoctoral tracking, outcomes research into the efficacy of osteopathic intervention, medical science research, autonomic correlation with disease entities, etiology of musculoskeletal dysfunction, billing information, and internal comparison studies between osteopathic physicians. A long-term goal of the SNF project is to create an electronic national database for osteopathic outcomes-based research.

	Background

Top Background Methods Results Comment References

 
Measuring Clinical Outcomes: Evidence-Based Medicine
"Clinical outcomes" has become an important buzzword in the lexicon of managed care. Measurements of clinical outcomes are used to predict the course of an illness and to analyze the efficacy of available treatment modalities.

Outcomes data can be divided into three groups: input (subject stratification by diagnosis), intervention, and outcomes.² Measuring clinical outcomes has been facilitated by the addition of symptom data (chief complaint), as well as functional assessments.³ Analysis of clinical outcomes and the incorporation of those results into the clinical setting leads to the practice of what is called evidence-based medicine.

Over the past several years, there has been increasing emphasis on outcomes measures, in particular on how various treatment modalities affect patients' health status. This type of research does not look at mechanisms or causes of change in patients' health status; its only concern is the end result of the clinical procedure or treatment under investigation.

Outcomes can include anything from physical data to patient quality of life and activities of daily living. Healthcare costs can also be examined, as can a combination of factors.

As managed-care organizations and government agencies increasingly rely on clinical outcomes measures to develop clinical practice guidelines, physicians will be asked to conform to these guidelines in their practices.^4,5

It has been suggested that a central resource, such as a professional organization or association, spearhead the development of such clinical practice guidelines with the active participation of member-physicians.⁶ By participating in this and similar processes, clinicians become de facto researchers and also, of necessity, develop lifelong learning skills. In addition, such participation ensures more physician control of what seems to be a shared destiny.

The creation of outcomes-based clinical practice guidelines for osteopathic medicine would serve to standardize osteopathic medical care on a national basis, and would also streamline the process of professional education assessment. Curricula in graduate medical education programs are already changing to more accurately reflect the current practice of medicine, which takes an integrated, problem-oriented approach.

In the present medical environment, it is essential that the osteopathic medical profession be able to conduct clinical outcomes-based studies. Methods of clinical data collection in practice-based settings must be developed and validated to enable osteopathic medical investigators to validate available prevention, diagnostic, and treatment modalities.

Developing the Evidence Base for Osteopathic Medicine
There have been many reports on the efficacy of osteopathic evaluation methods and osteopathic manipulative treatment (OMT) in the management of a host of diseases and disorders of structure and function.^7–9 However, corresponding basic science data in support of these findings—and that involve large numbers of human subjects—are relatively absent, primarily, we suggest, as a result of a lack of appropriate investigative technologies.^10,11

The solution to these deficiencies—and the key to the survival of the distinct clinical practice of osteopathic medicine—lies in cultivating solid osteopathic clinical outcomes data on a national scale. This goal, however, assumes standardization of osteopathic nomenclature and reporting methods involving trained investigators.

The Louisa Burns Osteopathic Research Committee and the SOAP Notes Form Project
Past
The problem-oriented medical record (known as PROMIS) was developed by Lawrence L. Weed, MD, in the 1950s and late 1960s,^12–14 and calls within the osteopathic medical profession for a common record-keeping system for osteopathic physicians based on the use of OMT did not follow far behind.¹⁰ Studies in subsequent years recommended the development of similar standardized record-keeping systems in osteopathic hospitals as a result of evidence that osteopathic structural evaluations were either not being performed on inpatients or that findings from those examinations were inaccurately recorded in patient medical records.¹⁵

Although there have been attempts to present a standardized format for such examinations,¹⁶ and standardization for research protocols have been discussed in various forums,^17–25 most of these efforts have been focused on providing complete guidelines for documenting osteopathic diagnosis and somatic dysfunctions—a process that would be too cumbersome for use with large groups of geographically diverse osteopathic physicians in outcomes-based research projects.

In March 1989, the Louisa Burns Osteopathic Research Committee (LBORC), the research branch of the American Academy of Osteopathy (AAO), began looking into a solution to these and other problems—as well as looking forward to larger possibilities for osteopathic medical research once these initial challenges were addressed.^26–32

The original SOAP (Subjective, Objective, Assessment, Plan) Notes Form (SNF)—which was designed, published, and distributed in 1998 (Figure 1)—covers the range of examination and treatment activities performed by osteopathic physicians during a patient encounter, enabling physicians to record data on a standard osteopathic musculoskeletal examination, enumerate any musculoskeletal dysfunctions found, document any OM techniques used, and report patient response to treatment. The 1998 SNF was a first step in providing standardized documentation for osteopathic outpatient practice in the United States.

View larger version (62K): [in this window] [in a new window]   Figure 1. Sample Outpatient Osteopathic SOAP (Subjective, Objective, Assessment, Plan) Note Form. (Reprinted with permission of the American Academy of Osteopathy. This form was originally published in JAOA—The Journal of the American Osteopathic Association in October 1999.26) This version of the SNF is no longer in use in clinical settings, however, having been updated after the present study was conducted. For the current version of this form, the second edition of the Outpatient Osteopathic SOAP Note Form Series (SNF-2E), please see the appendix, on pages 202 through 205 of this issue.

In recent years, sufficient data have been collected since the creation of the first edition of the SNF that members of the Committee (S.L.S., T.G.) were able to test the form for its intended use, outcomes research, in the present study.

Present
As a result of the recent emphasis on outcomes-based research in the field of medicine, the creation and use of a standardized tool for the osteopathic profession has been pursued by the LBORC with a renewed sense of urgency.^33,34 The need is acute for a standardized documentation format that allows osteopathic physicians to consistently report the incidence, symptom severity, treatment methods used, and related clinical outcomes for their patients with musculoskeletal dysfunction. The SNFs and the SOS-FS are valid and reliable tools that could readily fill this gap with widespread adoption within the osteopathic medical profession.^26,29 In fact, preliminary studies have successfully used the 1998 SNF to collect and report incidence of disease entities within a family practice setting.²⁸

View larger version (87K): [in this window] [in a new window]   Figure 2 Sample Outpatient Osteopathic SOAP (Subjective, Objective, Assessment, Plan) Note – Follow-up Form. This form consists of two pages. (Reprinted with permission of the American Academy of Osteopathy.) Copies of the Outpatient Osteopathic SOAP Note Form can be obtained from the American Academy of Osteopathy, 3500 DePauw Blvd, Ste 1080, Indianapolis, IN 46268-1136; telephone: (317) 879-1881. This form is also available online at http://www.academyofosteopathy.org/research_soap.cfm in a PDF (portable document format) file.

View larger version (37K): [in this window] [in a new window]   Figure 3. Seventeen Outcome-Based Questions Facing the Osteopathic Profession.

A standardized and widely used medical record is an essential requirement for these projects. Such standardization could eventually provide the basis for national database of osteopathic outcomes information that would be useful in documenting the efficacy of OMT for our patients and other researchers as well as for medical, legal, insurance, and other third-party groups.

The present study is the continuation of the long-term SNF project,^26–32 and was designed to show that the first edition of the Outpatient Osteopathic SNF (Figure 1) and the Outpatient Osteopathic SOAP Note – Follow-up Form (Figure 2) allow researchers to efficiently and effectively gather answers to basic outcomes-oriented questions. The 17 questions used (Figure 3) were designed by study investigators to measure incidence of somatic dysfunction, calculate averages, establish correlations, and make simple comparisons.

Researchers were able to answer all 17 questions efficiently and effectively using the data provided on the 1998 SNF. Incidence questions addressed severity of somatic dysfunction, the number of regions treated with OMT, OM techniques used, and subject responses to treatment. Averages questions (eg, subject age, duration of initial visit, time elapsed to follow-up) were also answered. Correlation questions (eg, disease entity and specific OM techniques used, severity of somatic dysfunction and subject response to OMT) were answered, as were questions on differences among diagnoses made by osteopathic physicians (eg, the top four International Classification of Diseases, 9th Revision (ICD-9-CM)³⁵ diagnosis codes).

In addition to answering the aforementioned outcomes questions, the SNF and its follow-up form could also be used to address the following functions: pre- and postdoctoral and tracking, additional outcomes research into the efficacy of osteopathic intervention, medical science research, autonomic correlation with disease entities, etiology of musculoskeletal dysfunction, billing information, and facilitation of internal comparisons among osteopathic physicians.

Future
Beyond the immediate concerns, however, members of the profession should consider the long-term value of a widely accessible database of clinical information that facilitates and accelerates medical outcomes research within osteopathic medicine.

Consider, for example, the Danish "Better Health for Mother and Child" cohort study. The goal of this long-term national outcomes project was the creation of a database that generations of investigators can use for studies on the effects of medical treatments.³⁶ Medical researchers in the United States, however, have historically preferred to design studies that answer specific questions and allow for long-term follow up.

One great strength of the SNF project is that it incorporates outcomes and clinical-trials methodologies. The goal of the SNF project is to create an osteopathic medical database for data mining following the Danish model while also conforming to the US model of answering specific clinical questions using the data available.

As noted, a persistent problem faced by the osteopathic medical profession has been a relative lack of reliable, easy-to-use systems of recording and collecting clinical findings in a format that is suitable for subsequent data collection. This lack has been, in part, responsible for the lack of a referable database from osteopathic physicians on the general parameters of osteopathic practice and the prevalence, frequency, and severity of somatic dysfunction in various patient populations—as well as the clinical effects of OMT.

One goal of the LBORC's SNF project is the creation of an electronic record of the outpatient osteopathic SNF for use by all osteopathic physicians and surgeons in the United States. The electronic version of the SNF (SNF EV) will include all standard demographic and medical information, as well as information and data specific to the practice of osteopathic medicine. The LBORC intends that SNF EV data will be transmitted via the Internet to a secure centralized location and that the data will be made available for use online by national and international physicians, researchers, and clinical investigators.

One of the principal advantages of using the multisite SNF EV as proposed by the LBORC is that participants will have the ability to record large quantities of patient data within a central repository over a relatively short period of time. With HIPAA (Health Insurance Portability and Accountability Act of 1996)-compliant oversight, data may then be analyzed in clinical research studies, vastly increasing efficiency over conventional (analog) methods. Participating clinicians would then be able to link the proposed SNF EV to decision support systems and have the option of modifying their practice patterns in response to a quickly changing environment.^37–39

	Methods

Top Background Methods Results Comment References

 
This retrospective study involves the recording of information from PPNs and is limited to the observation of note-keeping in outpatient medical offices. No patient names or identifying information were used. No changes in patient care or treatment procedures were involved. This study, therefore, is exempt from the requirement for full institutional review board review and informed consent agreements from study subjects taking part in original medical research as noted by National Institutes of Health and Office for Human Research Protections guidelines.

The study began after researchers received approval from the Biotechnical Institute's Human Subjects Committee at the University of Wisconsin at Parkside in Kenosha (ie, at the data-collection site). Approval was also sought and obtained from each of the three agencies with oversight at the colleges of osteopathic medicine and hospitals where physician-participants were employed: Colorado Springs Osteopathic Foundation Research Review Administration (Colorado Springs, Colo), Midwestern University Institutional Review Board (Downers Grove, Ill), and the University of North Texas Health Science Center at Fort Worth Texas College of Osteopathic Medicine (UNTHSC) Institutional Review Board for the Protection of Human Subjects.

All 10 osteopathic physicians who participated in this study were trained and certified in the use of the SOS-FS, which contained the trial SOS MSEF.²⁶ These 10 osteopathic physicians were asked to submit cases for the present study. Four physician-participants practice musculoskeletal medicine mainly; another four had practices that consisted of at least 40% musculoskeletal medicine; the remaining physician-participants practice some other form of medicine. Two undergraduate research fellows at one of the colleges of osteopathic medicine were also chosen to participate in the present study. All physician-participants were board certified in neuromusculoskeletal medicine to ensure a standard of competence in examination techniques and diagnosis. Further, physician-participants were chosen from various backgrounds: teaching institutions, private practice, and group practice. Prior to the start of this study, all 10 physician-participants were trained by the primary investigator (S.L.S.) and LBORC members in data collection using the SOS MSEF. The training sessions and certifications enhanced interexaminer reliability in this multisite study.

In addition, 196 osteopathic residents and undergraduate fellows were selected to serve as participants in the present study.⁴⁰ Osteopathic medical students were included as participants in the present to obtain their feedback on the forms, to involve them in the future of the profession, to encourage their familiarity with the forms (also enabling them to teach their peers about the forms' use), and to provide them with experience in participating in a multisite research project.

All participants were either trained and certified during courses at AOA or AAO conventions or were provided with private tutorials on the use of the SNFs and their follow-up forms. Participants who were tested and certified obtained a passing score in the transcription of cases onto the SOS MSEF, as described elsewhere.²⁹ All 10 participating osteopathic physicians had been using the outpatient osteopathic SNF routinely in their practice for at least six months before participation in the present study.

Among physician-participants, four were in private practice in various regions of the United States: Wisconsin, Illinois, Colorado, or New York. Among the records from the 196 osteopathic residents and undergraduate fellows, seven participating residents were based at these private practice sites; SNFs for this group were completed under the supervision of physician-participants.

The research site at UNTHSC provided the records of six attending physicians and 189 osteopathic residents and undergraduate fellows. At the Wisconsin site, there was one attending physician. At a hospital site in Illinois, there was one attending physician, one osteopathic manipulative medicine intern, and three osteopathic medical students.

In November 2002, study investigators (S.L.S. and T.G.) began a retrospective chart review of SNFs completed from January 2001 through June 2002.

Records submitted by participating osteopathic physicians, residents, and undergraduate fellows for review and analysis by study investigators had to meet one of the following criteria: (1) Participants who were technologically able to track patient visits by date through paper or electronic records were asked to make photocopies of SNFs for each subject seen from January 1, 2001, to May 31, 2002, for submission into the study; or (2) Participants who were not technologically able to track patient visits by date were asked instead to make photocopies of and submit every third SNF (with accompanying PPNs) in their chart file. To ensure adequate sampling of patient medical records, a maximum limit of 14 PPNs was set for submission of SNFs on any one subject.

To maintain patient confidentiality, participants were instructed to remove protected patient information and to place a randomly assigned 5-digit subject-specific identifier on submitted materials for each subject. Number ranges for participants to assign to their patient records were provided by the primary investigator (S.L.S.). Participants were asked to ensure that an ICD-9-CM numeric code was provided for each record submitted; records that contained written diagnoses instead had to be coded by participants before submission. Each of the six study sites maintained a log of each SNF with the following information:

• patient's name,
  
• patient's corresponding unique identifier (assigned by participant),
  
• participant's AOA member number (also known as "Record ID"),
  
• resident letter, if appropriate,
  
• case number,
  
• patient's letter on PPNs, as appropriate, for multiple sequential dates of service (eg, a patient receiving care on January 3, 2002, and February 14, 2002, would have the letters A and B assigned to those PPNs, respectively),
  
• date of office visit documented, and
  
• an indicator if the documented visit was an initial patient visit.
  

All participating osteopathic physicians, residents, and undergraduate fellows were also asked to maintain a secure personal log of their copied patient records with their unique identifiers to protect patient confidentiality and act as a point of reference for further inquiry should questions arise from investigators later. Participants were the only ones who had access to these logs; project personnel, including the investigators, and participants' staff members did not have access to these personal logs.

All participants were asked to mail copied SNFs to the central data-collection site at Crossroads Premiere Health Care, SC, in Kenosha, Wisc, for statistical outcomes analysis on the use of this standardized clinical recording instrument.

At the central data-collection site, records were reviewed consistent with HIPAA directives regarding patient and physician confidentiality and assigned unique identifiers for physicians and subjects were verified. Data processors at the study site color-coded files by study participant to assist in data organization. Color-coded files contained any SNFs submitted by that participant.

Seven staff members at the data-collection site were assigned to assist in data collection for the present study and were instructed in proper data-entry methods by the principal investigator (S.L.S.).^27,30 A Microsoft Access (version 98, Microsoft Corporation, Redmond, Wash) database that had been previously created and approved to answer the outcomes questions posed for this study was used by these staff members. To facilitate staff members' data-entry tasks, the principal investigator (S.L.S.) transcribed dictated PPNs onto SNFs.

Intradata reliability (ie, multiple records created by the same physician) was greater than 99.8% and involved the reentry of five randomly assigned cases. Interdata reliability (ie, among physician-participants) was greater than 91%. In this study, 20 cases were selected for testing, and data-entry errors were compared among the seven data-entry technicians.

Once data entry was complete, the frequencies statistic was used to search for frame shifts in data entry (ie, large blocks of data from a set of cases that had shifted as a result of deletion or duplication of one or more variables). Frame shifts were corrected. Other errors, such as single cell errors or omissions, were not corrected and were incorporated into the statistical analysis. Single cell errors or omissions represented valid physician or data-entry errors.

Subsequent to data entry, the following four general types of questions were addressed:

• Incidence—Subjects' sex, severity of somatic dysfunction (scale = 0 [lowest], 1, 2, 3 [highest]) for each body region, somatic dysfunction in each body region, number of regions treated with OMT, specific OM technique used, subject response to OMT, physician's evaluation before OMT, diagnosis by ICD-9-CM code, OMT performed by number of body regions, and physician-recommended follow-up time.³⁰
  
• Averages—Subjects' age, duration of office visit, and body regions evaluated and/or treated.
  
• Correlations—Diagnosis and specific OM techniques used; severity of somatic dysfunction and response to treatment; and disease entity diagnosed and the top four most severe forms of somatic dysfunction by body region.³⁰
  
• Differences—One overall comparison among osteopathic physicians in subject diagnosis and treatment.
  

Using SPSS statistical software (version 10.1, SPSS Inc, Chicago, Ill), appropriate statistical determinants were entered and analyzed, such as frequencies, correlations, and outcomes computations involving multiple variables.

	Results

Top Background Methods Results Comment References

 
Data from 3908 SNFs were entered by staff members at the data-collection site. With 3908 cases, there were 259 variables, and 1,012,172 cells of information were computed. Following is a summary of results by question type and item number (Figure 3):

Incidence Questions
Item 1: What is the incidence in women and men?

Data were reported for 2078 (72.4%) women and 792 (27.6%) men. Data on the sex of subjects were missing in 1038 (26.6%) cases.

Item 2: What is the incidence of severity (scale = 0 [lowest], 1, 2, 3 [highest]) of somatic dysfunction in each region of the musculoskeletal table?

The most severe somatic dysfunctions occurred with the greatest frequency in the cervical region (24.2%), followed by the lumbar (23.2%), head (22.1%), and thoracic T1 to T4 (20.5%) (Table 1).

Within the thoracic region, T10 to T12 had the lowest reported frequency (6%) for the highest severity rating.

For T1 to T4, T5 to T9, and ribs, fewer than 1% of responses were reported as "No somatic dysfunction found." In other words, if somatic dysfunction is found in any these body regions, the physician may anticipate finding a nonzero level of associated severity.

Item 3: What is the incidence of somatic dysfunction in each designated body region?

In this study population, the greatest incidence of somatic dysfunction was found in the cervical region (72.6%), with the occurrence in thoracic T1 to T4 (70.9%) being nearly as great (Table 2).

The lowest incidence of somatic dysfunction was found in the left upper extremity (26.8%).

Overall, more somatic dysfunction was found in the spinal areas than in the extremities.

Item 4: What is the incidence of osteopathic manipulative treatment (OMT) by body region?

Participants most commonly used OMT to treat subjects with somatic dysfunction when that dysfunction was located in the cervical region (60.6%) (Table 3). The next most frequently OMT-treated body region was thoracic T1 to T4 (56.4%), followed by the lumbar (55.8%) and sacral (55.6%) regions. The head (54.1%) and pelvis (51.4%) ranked fifth and sixth, respectively, in frequency for OMT.

Item 5: What is the incidence of specific osteopathic manipulative (OM) techniques used?

Articulatory and soft tissue techniques (18% each) were the most commonly used OM techniques (Table 4). These OM techniques were followed by direct (15.4%), muscle energy (12.5%), and myofascial release (11.9%) techniques.

View this table: [in this window] [in a new window]   Table 4 SOAP Note Form* Outcomes Research: OMT of Somatic Dysfunction, Techniques Used in All Body Regions (N = 54,712)

Because the database used for the present study contains specific identifiers for participating osteopathic physicians, residents, and undergraduate fellows, the data presented in Table 4 could theoretically have been subdivided by individual physicians, as well as by groups of physicians. Although detailed physician-specific information was beyond the scope of the present study, one can readily appreciate the potential uses of such detailed results for future studies.

Item 6: What is the incidence of responses (resolved, improved, unchanged, and worse) by body region following OMT?

In this study population, when somatic dysfunctions were treated, most conditions were either resolved (Table 5) or improved (Table 6). Few conditions were reported as unchanged (Table 7). There was only one instance in which a subject's condition actually worsened with OMT.

Dysfunctions of the pelvis were the most frequently resolved (26.2%) somatic dysfunctions reported, followed by lumbar (24.8%), thoracic T10 to T12 (24.3%), and sacral (24.3%) dysfunctions (Table 5).

Somatic dysfunctions in the cervical region were those most likely to be improved (36.7%), followed by head and thoracic T1 to T4 (29.9% each) (Table 6).

Item 7: What is the incidence of physician's evaluation before OMT for first visit: resolved, improved, unchanged, and worse?

Only 8% of patient encounters were with new patients or with established patients with new complaints.

For previously treated, established patients, evaluations before current-visit treatment with OMT revealed that 23% of patients felt their conditions had improved. Although 10% of patients reported that their conditions were unchanged, 5% reported that their conditions had worsened, and 1% of patients reported that their complaints were resolved.

Item 8: What is the incidence of diseases by ICD-9 code?

For the present study, 24,161 separate cells of information with ICD-9-CM code diagnoses were recorded in the database (Table 8), with up to 17 codes being recorded for one patient encounter, as happened in 10 cases. There were 520 individual ICD-9-CM codes used for diagnoses in this study.

View this table: [in this window] [in a new window]   Table 8 SOAP Note Form* Outcomes Research: ICD-9-CM Codes Recorded by Group (N=3908)

The most common ICD-9-CM diagnosis codes used by study participants were diseases of the musculoskeletal systems and connective tissue (89.22%); injury and poisoning (3.66%) (when the supplementary classification codes for external causes of injury and poisoning [0.26%] were also included); symptoms, signs, and ill-defined conditions (1.54%); diseases of the nervous system and sense organs (0.89%); and diseases of the digestive system and mental disorders (0.83% each) (Table 8).

Item 9: What is the incidence of OMT performed and recorded for 1 to 2, 3 to 4, 5 to 6, 7 to 8, and 9 to 10 musculoskeletal body regions? The number of body regions most frequently treated with OMT was 7 to 8 (35.9%), followed by 9 to 10 (23.3%), and 5 to 6 (20.6%) (Table 9).

Item 10: What is the most frequently recommended follow-up time? Study participants most commonly recommended that patients return for a follow-up visit in one week.

Averages Questions
Item 11: What is the average age of patients treated?

Data on patients' ages were reported for 2070 (53%) subjects. Among these subjects, the mean age was 43 years.

Item 12: What is the average visit duration?

Patient visits lasted an average of 36 minutes.

Item 13: What was the average number of regions evaluated and/or treated with OMT?

All body regions with somatic dysfunction severity ratings were essentially equal (ie, rounded to 100%) to the OMT-performed section of the musculoskeletal table (Table 1). When somatic dysfunction was present in this sample population, it was treated with OMT.

Moreover, the body regions for which OMT was performed equaled the number of regions marked in the "OMT performed as Above" section of the Outpatient Osteopathic Assessment and Plan Form (ie, fourth page of both the SOS MSEF²⁹ and the SNF-2E) and the second page of the Outpatient Osteopathic SOAP Note—Follow-up Form. As noted in Tables 5, 6, 7, regions treated with OMT equaled 21,091 for 3908 patient visits, or an average of 5.3 regions evaluated and treated per patient visit.

Correlations Questions
Item 14: Was there a correlation between disease entity and specific OM techniques used?

As noted, the OM techniques most commonly used by study participants to treat subjects ranked in the following order: articulatory and soft tissue (18% each), direct (15.4%), muscle energy (12.5%), and myofascial release (11.9%) (Table 4).

We further sought to determine whether any particular dysfunctions or disease entities at the highest severity level were treated preferentially using specific OM techniques (Table 10). In this study, the 739 ICD-9-CM numeric code series, Diseases of the musculoskeletal system and connective tissue – Osteopathies, chondropathies, and acquired musculoskeletal deformities – Nonallopathic lesions, not elsewhere classified (ie, all somatic dysfunctions), were the most frequently encountered, with the lowest incidence of this diagnosis type corresponding to code 739.9, Abdomen and other, and the maximum to code 739.2, Thoracic region, for all five of the most commonly used OM techniques (minimum count, maximum count):

View this table: [in this window] [in a new window]   Table 10 SOAP Note Form* Outcomes Research: Most Prevalent ICD-9-CM Codes Indicated at the Highest Severity Level for All Treatment Methods (N=18,079)

• articulatory, 435, 1279;
  
• direct, 464, 1472;
  
• muscle energy, 491, 1741;
  
• myofascial release, 240, 1108; and
  
• soft tissue, 462, 1545.
  

These five OM techniques were also most commonly used (44 times) by study participants for treating subjects with the following ICD-9-CM codes specified in their medical records:

• 719.48, Diseases of the musculoskeletal system and connective tissue — Arthropathies and related disorders – Other and unspecified disorders of joint – Pain in joint – Arthralgia;
  
• 729.1, Diseases of the musculoskeletal system and connective tissue – Rheumatism, excluding the back – Other disorders of soft tissues – Mylagia and myositis, unspecified (eg, fibromyalgia),
  
• 847 codes, Injury and poisoning – Sprains and strains of joints and adjacent muscles – Sprains and strains of other and unspecified parts of back, mainly neck (847.0) and thoracic (847.1).
  

Myofascial release was rarely used for diagnosis with ICD-9-CM code 307.81, Mental disorders – Neurotic disorders, personality disorders, and other nonpsychotic mental disorders – Special symptoms or syndromes, not elsewhere classified – Psychalgia – Tension headache (n=7). Myofascial release was also uncommon with two of the more common 847 codes, Injury and poisoning – Sprains and strains of joints and adjacent muscles – Sprains and strains of other and unspecified parts of back (ie, lumbar [847.2, n=39] and sacrum [847.3, n=18]). Myofascial release was commonly used, however, for the most common ICD-9-CM 847 code, thoracic (847.1, n=78).

Incidence for the use of myofascial release, direct, and muscle energy for ICD-9-CM diagnosis code 719.45, Diseases of the musculoskeletal system and connective tissue – Arthropathies and related disorders – Other and unspecified disorders of joint – Pain in joint – Pelvic region and thigh was at 50 or greater.

For diagnosis with the ICD-9-CM 723 codes, Diseases of the musculoskeletal system and connective tissue – Dorsopathies – Other disorders of cervical region, muscle energy and myofascial release were frequently used by study participants to treat subjects with cervicalgia (723.1, n85). In the treatment of subjects with cervicocranial syndrome (723.2), participants most commonly used articulatory, muscle energy, and soft tissue techniques (n72).

Muscle energy and myofascial release were the most frequently used OM techniques used by participants treating subjects at the highest severity level with ICD-9-CM diagnosis code 724.2, Diseases of the musculoskeletal system and connective tissue – Dorsopathies – Other and unspecified disorders of the back – Lumbago (n76).

For ICD-9-CM diagnosis code 728.85, Diseases of the musculoskeletal system and connective tissue – Rheumatism, excluding the back – Disorders of muscle, liagament, and fascia – Spasm of muscle, participants most commonly used articulatory, muscle energy, and soft tissue techniques (n62).

Muscle energy was used by participants to treat subjects with the most common diagnoses:

• 307.81, Mental disorders – Neurotic disorders, personality disorders, and other nonpsychotic mental disorders – Special symptoms or syndromes, not elsewhere classified – Tension headache;
  
• 719 codes, Arthropathies and related disorders – Other and unspecified disorders of joint – Pain in joint, mainly: pelvic region and thigh (719.45) and arthralgia (719.48);
  
• 723 codes, Diseases of the musculoskeletal system and connective tissue – Dorsopathies – Other disorders of cervical region, mainly: cervicalgia (723.1) and cervicocranial syndrome (723.2);
  
• 724.2, Diseases of the musculoskeletal system and connective tissue – Dorsopathies – Other and unspecified disorders of the back – Lumbago;
  
• 728.85, Diseases of the musculoskeletal system and connective tissue – Rheumatism, excluding the back – Disorders of muscle, liagament, and fascia – Spasm of muscle;
  
• 729.1, Diseases of the musculoskeletal system and connective tissue – Rheumatism, excluding the back – Other disorders of soft tissues – Mylagia and myositis, unspecified;
  
• 739 series, Osteopathies, chondropathies, and acquired musculoskeletal deformities – Nonallopathic lesions, not elsewhere classified: head region (739.0), cervical region (739.1), thoracic region (739.2), lumbar region (739.3), sacral region (739.4), pelvic region (739.5), lower extremities (739.6), upper extremities (739.7), rib cage (739.8), and abdomen and other (739.9); and
  
• 847 codes, Injury and poisoning – Sprains and strains of joints and adjacent muscles – Sprains and strains of other and unspecified parts of back, mainly: neck (847.0), thoracic region (847.1), lumbar region (847.2), and sacrum (847.3).
  

Item 15: Is there a correlation between severity of somatic dysfunction and the response to treatment?

The severity of somatic dysfunction (scale = 0 [lowest], 1, 2, 3 [highest]) for each body region and response to treatment (resolved, improved, unchanged, worse) were cross-tabulated, and the significance of the results for the Spearman rank correlation test (an ordinal-by-ordinal symmetric measure) was determined for each body region. In this analysis, there was a correlation for the head, thoracic T10 to T12, lumbar, pelvic, lower and upper extremities, ribs, abdomen (P<.001), and cervical regions (P=.001). There was not a correlation for thoracic T1 to T4 (P=.47), thoracic T5 to T9 (P=.10), and the sacrum (P=.72) at the .05 level.

Considering the three body regions that have the highest number of valid cases and high correlations—the thoracic T10 to T12 (n=1497, P=–.44), lumbar (n=1938, P=.322), and rib (n=1530, P=–.22)—the thoracic T10 to T12 and ribs were primarily noted as having been "improved" with OMT, whereas complaints with the lumbar region were noted as having been "resolved."

Item 16: Is there a correlation between disease entity and the top 4 most severe body regions for somatic dysfunction?

Other than the 739 ICD-9-CM numeric code series, Diseases of the musculoskeletal system and connective tissue – Osteopathies, chondropathies, and acquired musculoskeletal deformities – Nonallopathic lesions, not elsewhere classified (ie, all somatic dysfunctions), the most common ICD-9-CM diagnosis codes reported for all body regions were as follows:

• 307.81, Mental disorders – Neurotic disorders, personality disorders, and other nonpsychotic mental disorders – Special symptoms or syndromes, not elsewhere classified – Psychalgia – Tension headache;
  
• 719 codes, Diseases of the musculoskeletal system and connective tissue – Arthropathies and related disorders – Other and unspecified disorders of joint – Pain in joint, mainly of the pelvic region and thigh (719.45) and also arthralgia (719.48);
  
• 723 codes, Diseases of the musculoskeletal system and connective tissue – Dorsopathies – Other disorders of cervical region, mainly cervicalgia (723.1) and cervicocranial syndrome (723.2);
  
• 724.2, Diseases of the musculoskeletal system and connective tissue – Dorsopathies – Other and unspecified disorders of the back – Lumbago;
  
• 728.85, Diseases of the musculoskeletal system and connective tissue – Rheumatism, excluding the back – Disorders of muscle, liagament, and fascia – Spasm of muscle;
  
• 729.1, Diseases of the musculoskeletal system and connective tissue – Rheumatism, excluding the back – Other disorders of soft tissues – Mylagia and myositis, unspecified; and
  
• 847 codes, Injury and poisoning – Sprains and strains of joints and adjacent muscles – Sprains and strains of other and unspecified parts of back, mainly neck (847.0), thoracic region (847.1), lumbar region (847.2), and sacrum (847.3).
  

The dominant OM techniques used by participants were cranial osteopathy (1829, 46.80%) and muscle energy (1785, 45.68%). The cranial osteopathy technique was used primarily for treatment of the head (92.2%) whereas muscle energy was used to treat all body regions: head, 17.3%; cervical, 15.9%; T1 to T4, 22.1%; T5 to T9, 18.0%; T10 to T12, 14.2%; lumbar, 6.2%; sacral, 3.6%; pelvic, 1.7%; right upper extremity, 0.7%; and the remainder of regions accounted for less than 0.1%.

The body regions in which the greatest incidence of somatic dysfunction was found by study participants—that is, where the highest severity rating was most prevalent—were the head (mean severity level ± SE [standard error], 2.20 ± 0.017), cervical (2.169 ± 0.016), thoracic (T1 to T4, 2.115 ± 0.017; T5 to T9, 2.068 ± 0.019; T10 to T12, 1.570 ± 0.019), and lumbar (2.125 ± 0.018) (Table 10).

The dominant ICD-9-CM diagnosis codes for these body regions are, as noted elsewhere, the 739 ICD-9-CM numeric code series, Diseases of the musculoskeletal system and connective tissue – Osteopathies, chondropathies, and acquired musculoskeletal deformities – Nonallopathic lesions, not elsewhere classified, mainly of the following body regions: head (739.0), cervical (739.1), thoracic (739.2), and lumbar (739.3). Other dominant codes are:

• 847 codes, Injury and poisoning – Sprains and strains of joints and adjacent muscles – Sprains and strains of other and unspecified parts of back, mainly of the neck (847.0) thoracic (847.1), and lumbar (847.2) regions;
  
• 729.1, Diseases of the musculoskeletal system and connective tissue – Rheumatism, excluding the back – Other disorders of soft tissues – Mylagia and myositis, unspecified; and
  
• 307.81, Mental disorders – Neurotic disorders, personality disorders, and other nonpsychotic mental disorders – Special symptoms or syndromes, not elsewhere classified – Psychalgia – Tension headache.
  

In Table 11, the same analysis is presented but only for cases in which the muscle energy technique was used when participants provided OMT. The distribution of ICD-9-CM numeric codes under these restrictions is essentially the same when data are not separated for this particular OM technique (Table 10); however, this data restriction does reduce the incidence of dysfunction recorded for each body region. The distribution of other ICD-9-CM codes was altered between these outcome sets with, for example, the increased prominence of 728.85, Diseases of the musculoskeletal system and connective tissue – Rheumatism, excluding the back – Disorders of muscle, liagament, and fascia – Spasm of muscle.

View this table: [in this window] [in a new window]   Table 11 SOAP Note Form* Outcomes Research: Most Prevalent ICD-9-CM Codes Indicated at the Highest Severity Level for OMT Muscle Energy Technique (N=6933)

For all body regions, the dominant response to treatment was "improved" (head, 10.93%; cervical, 14.72%; T1 to T4, 13.47%; T5 to T9, 11.09%; T10 to T12, 13.18%; sacral, 9.09%), indicating that the OM muscle energy technique is a clinically efficacious treatment option in this population.

Differences Question
Item 17: What are the most frequently diagnosed and treated regions among providers?

For 7 of 10 participating osteopathic physicians, residents, and undergraduate fellows, the most commonly used diagnoses were two of the 739 codes, Diseases of the musculoskeletal system and connective tissue – Osteopathies, chondropathies, and acquired musculoskeletal deformities – Nonallopathic lesions, not elsewhere classified, specifically in the thoracic (739.2) and cervical (739.1) regions.

The cervical region code (739.1) had the second highest incidence of use, as reported by 8 of 10 participants, and was treated with OMT almost every time it was diagnosed. The thoracics were treated with OMT only 49.6% of the time. This disparity in the use of OMT between similarly diagnosed conditions in different body regions suggests that, at least among this group of osteopathic physicians, residents, and undergraduate fellows, somatic dysfunction of the thoracic region is treated with OMT less frequently than that of the cervical region.

	Comment

Top Background Methods Results Comment References

 
A valid, standardized, and easily incorporated osteopathic form is essential for documenting the incidence, symptom severity, treatment methods, and related outcomes of and for management of musculoskeletal dysfunction in osteopathic medical practices. Such a form is vital to the development of the osteopathic medical profession for describing osteopathic practice standards and rationalizing OPP to the medical, legal, and insurance communities.

Only through valid and consistent documentation can the osteopathic medical profession hope to obtain the necessary outcomes results that are now medical industry standards.

The SNF is a validated,²⁶ standardized form that has been proven in the present study to allow osteopathic physicians to effectively document frequency, severity, treatment, and related outcomes data in their management of musculoskeletal complaints among their patient populations.

Using the SNF, a diverse group of physicians from several geographic regions with different types of practices and trained and certified in the use of the SOS-FS was able to submit data to a central data-collection site where investigators could obtain useful outcomes-related data easily and efficiently.

The present study suggests that the application of the SNF to professional education assessment settings could substantially streamline current processes. Tracking the educational process would be simplified through the use of a standard tool that provides outcomes-based data.

For example, from the data collected in the present study, a method for extracting data for residents was successful. Five residents were selected and the ICD-9-CM codes they used were tabulated. Numbers of cases, numbers of ICD-9-CM codes, and frequencies of codes chosen were reviewed. Among this group, the most frequent diagnoses encountered were two 739 codes, Diseases of the musculoskeletal system and connective tissue – Osteopathies, chondropathies, and acquired musculoskeletal deformities – Nonallopathic lesions, not elsewhere classified, specifically of the thoracic (739.2) and cervical (739.1) regions. The OMT procedures residents used in association with treating patients with these dysfunctions could easily be obtained from the compiled data as well—as could the number of body regions treated. Residents could be easily tracked for parameters used to test resident competency, such as numbers of patients with certain diagnoses seen or specific procedures (eg, OM techniques) performed. With data obtained through participant-submitted SNFs, questions such as "How many patients have an elevation in blood pressure parameters but were not diagnosed with hypertension?"can be answered.

Many questions specific to a selected physician's practice could also be examined, for example: Which OM techniques does a particular osteopathic physician use most commonly? What is the average number of body regions per patient visit that a particular osteopathic physician treats with OMT? What is the patient response rate to OMT that a particular osteopathic physician has by body region? What is the particular osteopathic physician's patient-improvement rate after he or she provides OMT?

This trial involved 17 specific outcomes questions (Figure 3) that are now open for discussion among the osteopathic medical profession. The groundwork laid down by the SNF provides osteopathic physicians with a system for extracting answers to all of the questions posed—and has the potential to provide answers to many more outcomes-based questions.

Standardized use of the SNF allowed researchers to extract large amounts of data in a relatively quick and simple way in support of OPP. Based on evidence from the present study, we encourage further development of the proposed SNF EV, which would greatly contribute to streamlining the process of centralized data collection for osteopathic researchers.

	Acknowledgment

 
The authors thank the following colleagues for their participation in this project: David S. Abend, DO; Michael S. Carnes, DO; Jerry L. Dickey, DO; Russell G. Gamber, DO, MPH; Eric E. Gish, DO; Bernadette Goheen Kohn, DO; R. Paul Lee, DO; Scott T. Stoll, DO, PhD; and Stuart F. Williams, DO. The authors also thank the 189 osteopathic residents and undergraduate fellows at UNTHSC as well as the seven residents from the other study sites combined.

The authors recognize the contributions of William L. Kuchera, DO, who served as a consultant, composing the SNF forms and assisting in database construction.

The authors also thank the following people for assisting with data entry: Nancy Barbion, Sean Jaquish, Todd-Michael Larsen, Bethany Mondrawickas, Kenneth O. Polzin III, Yolanda Sanders, Brian T. Sleszynski, Cynthia L. Sleszynski, and Katherine A. Sleszynski.

	Footnotes

 
This study was funded by the Osteopathic Heritage Foundation, as recommended by the Bureau of Research of the American Osteopathic Association and was completed in collaboration with the work of the Louisa Burns Osteopathic Research Committee of the American Academy of Osteopathy (http://academyofosteopathy.org/research_lborc.cfm).

From the Osteopathic Manipulative Medicine Department at Midwestern University's Chicago College of Osteopathic Medicine in Downers Grove, Ill. Both authors are members of the Louisa Burns Osteopathic Research Committee, of which Dr Glonek is the current chairman.

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