- Email: [email protected]
Interexaminer reliability study of a standardized myofascial diagnostic technique of the superior thoracic inlet
Accepted Manuscript Interexaminer Reliability Study of a Standardized Myofascial Diagnostic Technique of the Superior Thoracic Inlet Daniel Hutchinson, OMS-III, Scott Hines, OMS-III, Nevin Vijayaraghavan, OMS-III, Andrew Sammond, OMS-III, Kristen Metzler-Wilson, PT, PhD, Michael L. Kuchera, DO PII:
S1360-8592(17)30104-3
DOI:
10.1016/j.jbmt.2017.05.004
Reference:
YJBMT 1527
To appear in:
Journal of Bodywork & Movement Therapies
Received Date: 7 April 2017 Revised Date:
9 May 2017
Accepted Date: 10 May 2017
Please cite this article as: Hutchinson, D., Hines, S., Vijayaraghavan, N., Sammond, A., Metzler-Wilson, K., Kuchera, M.L., Interexaminer Reliability Study of a Standardized Myofascial Diagnostic Technique of the Superior Thoracic Inlet, Journal of Bodywork & Movement Therapies (2017), doi: 10.1016/ j.jbmt.2017.05.004. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT
Superior Thoracic Inlet
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Interexaminer Reliability Study of a Standardized Myofascial Diagnostic Technique of the
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Daniel Hutchinson, OMS-IIIa Scott Hines, OMS-IIIa Nevin Vijayaraghavan, OMS-IIIa
a
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Andrew Sammond, OMS-IIIa Kristen Metzler-Wilson, PT, PhDa Michael L. Kuchera, DOa
Marian University College of Osteopathic Medicine, Indianapolis, IN
Conflicts of Interest: None
profit sectors.
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Address for Correspondence:
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Funding: This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-
Michael L. Kuchera, D.O., FAAO
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Marian University College of Osteopathic Medicine 3200 Cold Spring Rd
Indianapolis, IN 46222-1997 Phone/fax: 317-955-6279
Email: [email protected]
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ACCEPTED MANUSCRIPT Abstract Regional fascial motion palpation is often incorporated by osteopathic practitioners to enable them to identify superior thoracic inlet (STI) myofascial somatic dysfunction motion patterns; however without standardized instruction, diagnostic outcomes may vary between examiners. This study proposes a protocol for diagnosing the STI motion
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pattern that standardizes examiner hand placement, palpatory discrimination, posture, and relative body positioning. The study design incorporated useful infrastructure recommended by the Fédération Internationale de Médecine Manuelle (FIMM) including protocol agreement steps prior to conducting the formal interexaminer reliability study with
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the goals of attaining >80% interexaminer agreement and kappa values >0.6 for each cardinal plane. The agreement phase comprised of testing 52 participants acquired agreements of 92.3% (rotation), 88.9% (translation), and 94.2%
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(sagittal). Kappa value testing involving an additional 82 participants obtained values of 0.65 (rotation), 0.59 (translation), and 0.70 (sagittal). Such kappa values endorse fair-to-excellent positive interexaminer correlations,
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demonstrating utility of this standardized palpatory protocol for STI myofascial dysfunctional diagnosis.
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INTRODUCTION
The development of information regarding diagnosis and treatment of regional fascial dysfunction owes a great deal to
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J. Gordon Zink D.O. and W. Lawson Ph.D. (Zink & Lawson, 1979).Their functional interpretation of such palpatory somatic findings influenced countless students and clinicians to include myofascial palpation of regional transitional zones when considering the significant relationship between fascia and lymphatic flow (Kuchera, 2011). Zink
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contemplated that as the body deals with trauma, whether it be minor constant trauma resulting from poor posture or major trauma such as that resulting from a motor vehicle accident, the connective tissues that make up the fascia, adjust
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in order to compensate for the external forces impacting the body. The modifications that occur in an attempt to maintain physical tensegrity can affect the function and thus eventually the structure of various tissues throughout the body (Swanson, 2013).
Though definitions vary, it is widely agreed that the functional superior thoracic inlet (STI) consists of the manubrium,
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ribs 1-2 (R1-2), and first 4 thoracic vertebrae (T1-4) (Kuchera, 2011). Somatic dysfunction of the STI directly affects the function of the superior thoracic outlet, which may, in turn, affect the brachial plexus, subclavian arteries and subclavian veins. Myofascial dysfunction of the STI can specifically obstruct the entire body’s lymphatic drainage into the subclavian
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veins as they pass through Sibson’s fascia (Chikly, 1997; Kuchera, 2011). Lymphatic stasis decreases the clearance of degraded waste products and reactive oxygen species created through inflammation and tissue damage, leading to an
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increase in recovery time from infections, accumulated edema, and other pathologies (Degenhardt & Kuchera, 1996).
The primary step in normalizing the structure and function of the STI in order to augment lymphatic drainage is to accurately diagnose the direction and pattern of fascial dysfunction so that it can be properly treated with manual techniques (Zink, 1977). Accurate identification of the direction and pattern of ease and bind to motion is essential in designing and carrying out many manual treatment interventions including direct and indirect myofascial release techniques (Johnson & Kurtz, 2003). Diagnosis is made by placement of the examiner’s hands on the STI and sequentially
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ACCEPTED MANUSCRIPT testing the regional fascial movement for somatic dysfunction using the palpatory end-feel of each motion barrier in each direction to determine the participant’s regional myofascial motion directional preference (Kuchera & Kuchera, 2012).
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Since it is common to teach the Zink regional fascial diagnostic approach in osteopathic medical schools, consistency in the conduct of palpatory technique at each regional site is an important, yet commonly overlooked, aspect for both teaching and clinical interpretation. Dr. Zink documented his approach to regional fascial diagnosis in the context of
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torsional and rotational fascial patterns that cause the restrictions in lymphatic flow (Kuchera, 2011; Zink, 1973). The current study was designed to validate a standardized process for fascial pattern motion diagnosis of the STI through
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creation of a specific palpatory protocol that can be used by any osteopathic practitioner to diagnose the fascial pattern in all 3 planes at this regional site. Achieving a strong interexaminer agreement within such a standardized protocol demonstrates reproducibility and the ability to attain a consistent diagnosis of myofascial somatic dysfunction that can then be acted upon through manipulative treatment. Such a protocol would provide a consistent foundation to effectively teach osteopathic and other manual practitioners how to diagnose the STI and the potential for use in future
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studies to document the efficacy of various techniques to modify this somatic dysfunction.
Interexaminer reliability studies are critical in evaluating a proposed protocol because they characterize the extent to
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which the data collected correctly represent the variables measured (McHugh, 2012). Simple percent agreement calculations are not accurate representations of interexaminer reliability because they do not account for chance
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agreement. The kappa statistical method developed by Jacob Cohen is currently regarded as the leading method used to test interexaminer reliability because it accounts for chance agreement, but it should still be compared against percent agreement since both are suggested as being critical aspects of healthcare studies (Chen et al., 2014).
There are multiple sources that evaluate kappa values in relation to the strength of agreement using differing schemes. Clinicians interpret kappa values for manual medicine studies one way (Patjin, 2004; see Table 1), while Altman uses an alternative interpretation of kappa values (Altman, 1990; see Table 2).
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PLACE TABLE 1 HERE
METHODS
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PLACE TABLE 2 HERE
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In the agreement phase of this study, anatomical landmarks such as the spinous process of T1, the sternoclavicular joints, and the pectoralis major muscles were agreed upon by the study team and used to help guide the examiner’s
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hand placement before diagnosing the fascial pattern of the STI. All examiners were third year osteopathic medical students (OMS-III) who had attended weekly lab sessions for two academic years with an osteopathic physicianeducator with 35+ years’ experience diagnosing and treating Zink fascial patterns in order to learn proper location of these landmarks for hand placement and skill in assessing the quality of the barrier end-feel associated with a variety of somatic tissues. This educator has extensive experience with interexaminer reliability studies and thus aided in the
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creation of a succinct and detailed protocol.
This study consisted of two stages: (1) Agreement Phase and (2) Interexaminer Reliability Kappa Study Phase. It was
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developed using the Fédération Internationale de Médecine Manuelle (FIMM) Protocol as a general infrastructure, which utilizes seven golden rules that are based on the different aspects and stages of a reproducibility study (Patjin,
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2004; see Table 3).
PLACE TABLE 3 HERE
Approval
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ACCEPTED MANUSCRIPT This protocol was approved by the Marian University Biomedical Institutional Review Board and conforms to the Declaration of Helsinki.
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Examiners
The participating examiners comprised two OMS-III students from Marian University College of Osteopathic Medicine. Both examiners received the same amount of osteopathic education under supervision from the same faculty. In order
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to eliminate evaluation bias, both examiners were blinded to the fascial patterns of the participants they examined and were not aware of the other examiner’s findings. A third OMS-III student from the same school and of the same level of
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competency was present as the official recorder to corroborate that the examiners followed every step of the agreed upon protocol throughout the diagnosis of participant’s fascial patterns and logged the results, while ensuring that both examiners remained blinded throughout the study. The recorder was also responsible for enrolling participants meeting
Participating subjects
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the criteria for analysis per protocol.
Osteopathic, nursing, and biomedical sciences students at Marian University aged 18-30 years were invited to enroll as
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participants in the study. Exclusion criteria included those with a history of surgery or injury involving the cervical or thoracic regions, connective tissue disease, skin disease, active infections, active muscle cramps or spasms, thoracic
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manipulation/massage within the past 5 days, or the inability to comfortably lie in the supine position for short lengths of time. Male participants were examined without shirt or shoes. Female participants were examined in sports bras. Lower body clothing was not discriminated. Earrings, necklaces and other jewelry in the thoracocervical region were removed from participants prior to evaluation. To avoid examiner fatigue, no more than 30 participants were examined on a given date. All participants were examined by both examiners.
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ACCEPTED MANUSCRIPT Fifty-two participants (18 females, 34 males) were tested during the Agreement Phase and 82 participants (41 females, 41 males) were tested during the Interexaminer Kappa (Κ) Statistic Phase.
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Obtaining interexaminer agreement
In the Agreement Phase of this study, 52 participants gave both verbal and written consent prior to being tested. Each participant was examined by the examiners separately with the order of examiners alternated to randomize the
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population to potential hysteresis change influences of the palpatory motion testing process of the first examiner on the second examiner’s STI fascial diagnosis. The precise examination steps to be used had been thoroughly discussed and
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agreed upon in advance after literature review and a series of five discussion meetings. The examinations took place on a standard flat osteopathic manipulation treatment (OMT) table that was adjustable for height. The subjects were examined with the examiner seated on an adjustable chair at the head of the OMT table set to be level with the examiner’s umbilicus.
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Participants were instructed to lie supine with their head on the side of the table closest to the examiner one-fist length away from the end of the table. The participants lay flat on the table with their feet together and their arms to their sides. They were instructed to lift both knees and hips fully off the table and then return to the supine position. The
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subject (see Figure 1):
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participants were instructed to lie still for one minute before placement of Examiner 1’s right and left hands on the
Digit 1 (thumb): posteriorly over the articulation between T1 transverse process and the first rib Digit 2: immediately inferolateral to the sternoclavicular (SC) joint Digits 3-5: evenly spread over the pectoralis major muscle at the level of the second rib
PLACE FIGURE 1 HERE
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ACCEPTED MANUSCRIPT *NOTE: It was agreed that should the examiner’s hands not be large enough to correctly place all digits, digits 2-5 were prioritized with digit 1 being naturally extended over the trapezius muscle. (This however was not necessary for the examiners and subject population involved in this study).
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Examiners positioned themselves with their dominant eye (as confirmed by the Miles Test (Miles, 1930)) directly in line with the subject’s longitudinal midline and with their feet flat on the floor. While keeping their elbows at approximately 135° and not allowing them to rest on the table, examiners used compressive forces to palpate deep to the skin and
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subcutaneous tissue until they felt the fascia over the first muscle layer, assuming that once soft-tissue is sensed the myofascial tissue is being palpated. Examiners then independently and sequentially tested for ease or bind barrier end-
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feels in each of the 3 cardinal fascial planes (rotational, translational, and then sagittal) and named the somatic dysfunction for the direction of ease (which direction the fascial barrier end-feels preferred to move). Results were verbally conveyed to the recorder without any feedback to the examiner and the first examiner left the room. Examiner 2 immediately entered upon Examiner 1 leaving and instructed the participant to again lift both knees and hips fully off the table and then return to the supine position. The participant was instructed to lie still for 1 minute before Examiner
RESULTS
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planes using the same protocol.
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2 tested the same participant without any knowledge of prior results, providing a separate diagnosis in each of the 3
Agreement results
Before collecting data to calculate a kappa value related to a specific protocol (Viera & Garrett, 2005), it is essential to first attain solid interexaminer agreement to ensure the protocol can achieve similar results between multiple examiners. As outlined by the FIMM Protocol, the examiners agreed to obtain > 80% interexaminer agreement of each plane of the regional myofascial diagnosis in the agreement phase before moving on to the interexaminer kappa statistic
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ACCEPTED MANUSCRIPT evaluation. If this goal was not reached, modifications would have been made to the protocol based on feedback from participants. However, this was not necessary as the protocol was successful in the Agreement Phase.
Fifty-two participants (18 females, 34 males) were examined over 2 consecutive days using the protocol and the results
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were as follows (see Table 4).
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PLACE TABLE 4 HERE
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Kappa statistic results
Calculation of a kappa value requires assigning outcomes as “positive” (+) or “negative” (-) for the test; in this case for each plane tested (Patjin, 2004). Examiners defined “positive” and “negative” as shown in Table 5.
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PLACE TABLE 5 HERE
Once data were collected, kappa statistic required calculation of the Observed Accuracy and Expected Accuracy. Both
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were then used in the Kappa Equation to determine the kappa value. The equations used to determine the kappa values
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are as follows:
Observed Accuracy =
Marginal Frequency =
Expected Accuracy =
#
#
#
#
+
#
#
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Kappa Value =
! "
# ! "
Participants were diagnosed using the agreed-upon protocol until each examiner had 10 positive diagnoses and 10
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negative diagnoses in each plane in order to further randomize and strengthen the data collected. Eighty-two participants (41 females, 41 males) were diagnosed using the palpatory diagnostic protocol with results as shown in
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Tables 6 to 8.
The rotational plane had an Observed Accuracy of 0.841, an Expected Accuracy of 0.546, and a Kappa value (Κ) of 0.65.
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This Kappa value is interpreted as having a high strength of interexaminer agreement by Altman and a good-to-excellent strength of interexaminer agreement by the FIMM Protocol (see Table 6).
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PLACE TABLE 6 HERE
The translational plane had an Observed Accuracy of 0.805 and an Expected Accuracy of 0.529, and Κ = 0.59. This Kappa value is interpreted as having a moderate strength of interexaminer agreement by Altman and a fair-to-good strength of
PLACE TABLE 7 HERE
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interexaminer agreement by the FIMM Protocol (see Table 7).
The sagittal plane had an Observed Accuracy of 0.866 and an Expected Accuracy of 0.546, and Κ = 0.70 (see Table 8). This Κ is interpreted as having a high strength of interexaminer agreement by Altman (see Table 9) and a good-to-excellent strength of interexaminer agreement by the FIMM Protocol (see Table 10).
PLACE TABLE 8 HERE
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ACCEPTED MANUSCRIPT DISCUSSION
The results of this study, achieved through testing of an equal number of healthy males and females (n = 82) using 2 different kappa value classification systems, demonstrating moderate-to-high agreement based on the Altman
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conditions (see Table 9) and fair-to-excellent agreement based on the FIMM clinical classification (see Table 10). Both interpretations indicated that this standardized study protocol effectively captures the diagnosis of the myofascial motion dysfunction patterns of the STI, in a manner that could be taught, learned, and applied to make a consistent
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diagnosis of regional STI fascial dysfunction. Assuring reproducible diagnosis of somatic dysfunction is an essential step in conducting subsequent research to determine if there are physiological or clinical outcomes achieved by removing
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that somatic dysfunction compared to controls where the dysfunction is documented to remain (Patjin, 2004).
PLACE TABLE 9 HERE
PLACE TABLE 10 HERE
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This interexaminer reliability study protocol considered the suggestions of Michael Seffinger, DO and colleagues in their systematic review of interexaminer reliability studies dealing with segmental spinal palpatory diagnostic techniques. In their interdisciplinary review the authors state the importance of minimizing bias, development of assessment
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instruments after careful consideration of prior guidelines, blinding the examiners, and realizing that regional range of motion is more reliable that segmental range of motion (Seffinger et al., 2004). The design of this study incorporated
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many of these suggestions as was minimized by enrollment of a gender-balanced population with adequate numbers of subjects having both left and right fascial directional preferences, development of the assessment tool occurred through a series of meetings discussing educational experiences and literature detailing the subject matter, examiners were ensured to be blinded to possible results by the recorder and randomized subjects, and regional range of motion was used through ease-bind motion testing in each cardinal plane of the myofascial structures over the entire STI rather than its individual segmental components.
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ACCEPTED MANUSCRIPT Systematic reviews of interexaminer reliability studies require a quality assessment tool that is consistently used to evaluate studies of diagnostic procedures. The diagnostic reliability appraisal tool Quality Appraisal of Reliability Studies (QAREL) was developed by Lucas and colleagues (Lucas et al., 2010). QAREL consists of an 11-item checklist that explores seven principles covering the spectrum of subjects, spectrum of examiners, examiner blinding, order effects of
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examination, suitability of the time interval among repeated measurements, appropriate test application and interpretation, and appropriate statistical analysis. Each consideration of the QAREL 11-item checklist was carefully
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PLACE TABLE 11 HERE
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reflected in the creation of this study’s interexaminer reliability protocol (see Table 11).
Furthermore, while heavily influenced by FIMM reproducibility study guidelines, not all of its recommendations were incorporated. While the FIMM guidelines suggest using 40 subjects for simple reproducibility studies (Patjin, 2004), a larger number was used in this study in order to better achieve a significant population size in order to further test the reproducibility of this study’s standardized technique in each of the 3 cardinal planes during the same study. FIMM
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guidelines suggest each examiner send 10 positive and 10 negative subject outcomes in each tested finding to the other examiner. Such a study design minimizes maldistribution of outcomes that could bias the examiners (Patjin, 2004). However, no matter the number of subjects tested, an important statistical consideration is to keep the number of
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positive and negative outcomes in each tested arm as close to equal as possible. In the “real world” distribution, the present study did not use equal numbers of positive and negative outcomes in each plane, leading the authors to believe
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that the kappa numbers might be even higher had this portion of the FIMM guidelines been followed. While examiners in this study tested subjects until at least 10 positive and 10 negative outcomes were achieved in each plane and the current data could be used to go back and use each examiner’s first 10 positive and 10 negative outcomes before sending the subject to the other examiner, authors did not do so as this would not retain other aspects of the 3 plane analysis.
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ACCEPTED MANUSCRIPT When diagnosing the STI fascial patterns, this study’s protocol did not set a limit on how many times an examiner could test each direction to find the direction of ease. Not deciding on a maximum number of times each direction was to be tested could have changed the hysteresis patterns inherently present within each test subject (Barnes et al., 2013). This may have affected the second examiner’s results, as the fascial patterns could have significantly changed after Examiner
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1’s diagnosis (Kuchera et al., 2010). In future studies, examiners should limit their movements in each direction when testing subjects; this could potentially enhance interexaminer reliability measures further. While there was not a set number of palpatory movements by examiners under this protocol, each examiner in this study was consistent in
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attempting to limit their palpatory movements in order to limit hysteresis changes while attaining a diagnosis.
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The hand placement of the examiners could be difficult to standardize depending on examiners’ hand size. In the present study, both examiners were able to place their hands on the appropriate landmarks without difficulty. However, if an examiner’s hands are too small to reach all landmarks, the diagnosis may be affected. Additionally, every participant has a different body type, which would also add a variable that is difficult to control with the protocol as described in the current study. While the study’s protocol incorporated a proposed alternative in such a situation, this
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study did not encounter the situation, so mismatched examiner-subject size issues were not tested in this study.
Due to prior experience of testing a large number of subjects at once in which examiner fatigue became a possible factor
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affecting the accuracy of their diagnosis, the researchers in the current study compensated by testing subjects over multiple days and testing no more than 30 subjects in a day. That number was arbitrarily determined and future studies
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may warrant fewer subjects being evaluated in a given session.
Future studies could expand this type of interexaminer reliability investigation in a variety of ways. Dr. Zink and those using his approach to evaluating regional palpatory characteristics studied more than just the STI region when discussing fascial motion patterns; future studies could evaluate fascial patterns in the cervico-cranial, thoraco-lumbar, or lumbosacral regions. Use of a fixed camera and software that analyzes photographs of examiners testing the subjects could not only assist in determining whether the examiners agree on a directional diagnosis, but also quantify (in mm) to what
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ACCEPTED MANUSCRIPT specific degree they find agreement. This would allow for more precise measurements that give more detailed and quantifiable data about the diagnosis of the fascial patterns.
It may also be worthwhile to examine if this study’s protocol yields equally successful results with examiners who are
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allopathic medical students or physicians, chiropractors, physical therapists, and other practitioners not formally trained to palpate for somatic dysfunction. As manual medicine becomes increasingly accepted in the medical community, practitioners of all specialties and educational backgrounds concerning the spectrum of manual therapies should have
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simple and effective methods of learning these important skills. It is the authors’ hope that this palpatory protocol provides a strong foundation towards developing such methods and expanding the reach of palpatory diagnosis and use
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of manual care for patient benefit.
CONCLUSION
Overall, the results of this study indicate that the palpatory protocol successfully standardized the diagnosis of STI
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somatic dysfunction. With further study and modification with the suggestions in this discussion, the protocol could be improved to possibly obtain even higher interexaminer agreement for all 3 fascial planes. The authors hope that this interexaminer reliability study is replicated in the future and eventually used to standardize regional fascial diagnosis
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education and clinical interpretations. A standardized protocol, such as the one created in this study, can be an effective tool to teach analysis of regional myofascial palpatory patterns. The authors hope that this protocol for the regional
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myofascial diagnosis of the STI, along with protocols for many other palpatory techniques, will continue to be researched in the future and lead to the advancement of the evidence-base used in teaching, interpreting and clinically applying manual therapeutics.
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ACCEPTED MANUSCRIPT Acknowledgements The authors gratefully acknowledge Jeffry Kellogg, Ph.D. (Professor, Department of Psychology; Marian University; Indianapolis IN, USA) for his statistical review and William A. Kuchera, DO, FAAO (Emeritus Professor, Department of Osteopathic Manipulative Medicine; AT Still University – Kirksville College of Osteopathic Medicine; Kirksville MO, USA)
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for Figure 1 artwork. The authors also wish to express appreciation to the subjects for their willing participation.
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REFERENCES
Altman DG 1990 Practical statistics for medical research. CRC Press, Cleveland, OH.
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Barnes PL, Laboy F, 3rd, Noto-Bell L, Ferencz V, Nelson J, Kuchera ML 2013 A comparative study of cervical hysteresis characteristics after various osteopathic manipulative treatment (OMT) modalities. J Bodyw Mov Ther 17, 89-94. Chen H, Hailey D, Wang N, Yu P 2014 A review of data quality assessment methods for public health information systems. Int J Environ Res Public Health 11, 5170-5207.
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Chikly B 1997 Who discovered the lymphatic system? Lymphology 30, 186-193.
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Degenhardt BF, Kuchera ML 1996 Update on osteopathic medical concepts and the lymphatic system. J Am Osteopath Assoc 96, 97-100. Johnson SM, Kurtz ME 2003 Osteopathic manipulative treatment techniques preferred by contemporary osteopathic physicians. J Am Osteopath Assoc 103, 219-224. Kuchera ML, Casella F, Nelson J, Ferencz V, Myers NE 2010 Effect of a prior anterior superior iliac spine compression testing on second assessor findings: Implications for inter-examiner reliability testing. Manuelle Medizin 48, 369.
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Kuchera ML 2011 Lymphatics approach, in: Chila A (Ed.), Foundations of Osteopathic Medicine, 3rd ed. Lippincott Williams & Wilkins, Philadelphia, PA pp. 786-808. Kuchera ML, Kuchera WA 2012 Osteopathic considerations in HEENT disorders. Greyden Press, Dayton, OH.
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Lucas NP, Macaskill P, Irwig L, Bogduk N 2010 The development of a quality appraisal tool for studies of diagnostic reliability (QAREL). J Clin Epidemiol 63, 854-861. McHugh ML 2012 Interrater reliability: the kappa statistic. Biochem Med (Zagreb) 22, 276-282.
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Miles WR 1930 Ocular dominance in human adults. J Gen Psych 3, 412-430. Patjin J 2004 Reproducibility and validity studies of diagnostic procedures in manual/musculoskeletal medicine, 3rd ed. International Federation for Manual/Musculoskeletal Medicine Scientific Committee. Seffinger MA, Najm WI, Mishra SI, Adams A, Dickerson VM, Murphy LS, Reinsch S 2004 Reliability of spinal palpation for diagnosis of back and neck pain: a systematic review of the literature. Spine (Phila PA 1976) 29, E413-425. Swanson RL, 2nd 2013 Biotensegrity: a unifying theory of biological architecture with applications to osteopathic practice, education, and research--a review and analysis. J Am Osteopath Assoc 113, 34-52. Viera AJ, Garrett JM 2005 Understanding interobserver agreement: the kappa statistic. Fam Med 37, 360-363.
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ACCEPTED MANUSCRIPT Zink JG 1973 Applications of the osteopathic holistic approach to homeostasis. Am Acad of Osteo Yearb, 37-47. Zink JG 1977 Respiratory and circulatory care: the conceptual model. Osteopath Ann 5, 108-112.
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Zink JG, Lawson WB 1979 An osteopathic structural examination and functional interpretation of the soma. Osteopath Ann 7, 12-19.
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ACCEPTED MANUSCRIPT Table 1. FIMM Protocol Kappa Value Interpretation Strength of Agreement
Κ < 0.4
Poor
Κ =0.4 – 0.6
Fair to Good
Κ > 0.6
Good to Excellent
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Kappa Value (Κ)
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ACCEPTED MANUSCRIPT Table 2. Altman Kappa Value Interpretation Strength of Agreement
Κ < 0.2
Poor
Κ =0.21 – 0.4
Fair
Κ =0.41 – 0.6
Moderate
Κ =0.61 – 0.8
High
Κ =0.81 – 1.0
Very High
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Kappa Value (Κ)
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ACCEPTED MANUSCRIPT Table 3. FIMM Protocol Seven Golden Rules (Patijn, 2004) FIMM Protocol Seven Golden Rules Create a clear logistic and responsibility structure for the reproducibility study.
Rule #2
Always create a training period before performing a reproducibility study.
Rule #3
Always create an overall agreement period before performing a reproducibility study.
Rule #4
Always use a blinding procedure in a reproducibility study.
Rule #5
Always define the population from which the subjects are selected.
Rule #6
Always mention the definition of the source population, the selection method, the blinding procedure,
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Rule #1
the definition of test procedure and test results in materials and methods when publishing.
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Always show a 2 x 2 contingency table with the prevalence and overall agreement figures in results
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when publishing a reproducibility study.
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Rule #7
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ACCEPTED MANUSCRIPT Table 4. Agreement Phase Results
Number Agreement Percent Agreement
48/52
92.3%
Translational Plane
46/52
88.9%
Sagittal Plane
49/52
94.2%
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Rotational Plane
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ACCEPTED MANUSCRIPT Table 5. Positive & Negative Test Outcome Assignments for Kappa Testing
Rotational Plane Translational Plane Sagittal Plane
right
right
anterior
Negative (-)
left
left
posterior
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Positive (+)
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ACCEPTED MANUSCRIPT Table 6. Rotational Plane Kappa Value Testing Outcomes Rotational Plane
Examiner 1
Positive (+) Negative (-)
47
Negative (-)
5
8
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Positive (+)
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Examiner 2
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ACCEPTED MANUSCRIPT Table 7. Translational Plane Kappa Value Testing Outcomes
Translational Plane
Examiner 1
Positive (+) Negative (-)
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Negative (-)
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Positive (+)
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Examiner 2
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ACCEPTED MANUSCRIPT Table 8. Sagittal Plane Kappa Value Testing Outcomes
Sagittal Plane
Examiner 1
Positive (+) Negative (-)
48
Negative (-)
5
6
23
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Positive (+)
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ACCEPTED MANUSCRIPT Table 9. Kappa Value Results Interpretation by Altman
Kappa Interpretation Kappa Value (Κ) Strength of Agreement
0.65
High
Translational Plane
0.59
Moderate
Sagittal Plane
0.70
High
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Rotational Plane
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ACCEPTED MANUSCRIPT Table 10. Kappa Value Results Interpretation by FIMM Protocol Kappa Interpretation Kappa Value (Κ) Strength of Agreement
0.65
Good to Excellent
Translational Plane
0.59
Fair to Good
Sagittal Plane
0.70
Good to Excellent
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Rotational Plane
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ACCEPTED MANUSCRIPT Table 11. QAREL 11-Item Checklist Quality Assessment Tool for Diagnostic Reliability Studies
Item #9 Item #10 Item #11
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Item #7 Item #8
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Item #6
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Item #3 Item #4
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Item #2
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Item #1
QAREL Checklist Was the test evaluated in a sample of subjects who were representative of those to whom the authors intended the results to be applied? Was the test performed by raters who were representative of those to whom the authors intended the results to be applied? Were the raters blinded to the findings of other raters during the study? Were the raters blinded to the own prior findings of the test under evaluation? Were the raters blinded to the results of the accepted reference standard or disease status for the target disorder (or variable) being tested? Were the raters blinded to clinical information that was not intended to be provided as part of the testing procedure or study design? Were the raters blinded to additional cues that were not part of the test? Was the order of examination varied? Was the stability (or theoretical stability) of the variable being measured taken into account when determining the suitability of the time-interval between repeated measures? Was the test applied correctly and interpreted appropriately? Were appropriate statistical measures of agreement used?
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Figure 1. Hand Placement for Superior Thoracic Inlet Palpatory Diagnosis (Myofascial Motion Preference) Protocol. Sequentially applied motion for: (1) Rotation preference; (2) Translational (sidebending) preference; (3) Sagittal (forward-backward bending) preference.
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S1360-8592(17)30104-3
DOI:
10.1016/j.jbmt.2017.05.004
Reference:
YJBMT 1527
To appear in:
Journal of Bodywork & Movement Therapies
Received Date: 7 April 2017 Revised Date:
9 May 2017
Accepted Date: 10 May 2017
Please cite this article as: Hutchinson, D., Hines, S., Vijayaraghavan, N., Sammond, A., Metzler-Wilson, K., Kuchera, M.L., Interexaminer Reliability Study of a Standardized Myofascial Diagnostic Technique of the Superior Thoracic Inlet, Journal of Bodywork & Movement Therapies (2017), doi: 10.1016/ j.jbmt.2017.05.004. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
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Superior Thoracic Inlet
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Interexaminer Reliability Study of a Standardized Myofascial Diagnostic Technique of the
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Daniel Hutchinson, OMS-IIIa Scott Hines, OMS-IIIa Nevin Vijayaraghavan, OMS-IIIa
a
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Andrew Sammond, OMS-IIIa Kristen Metzler-Wilson, PT, PhDa Michael L. Kuchera, DOa
Marian University College of Osteopathic Medicine, Indianapolis, IN
Conflicts of Interest: None
profit sectors.
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Address for Correspondence:
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Funding: This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-
Michael L. Kuchera, D.O., FAAO
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Marian University College of Osteopathic Medicine 3200 Cold Spring Rd
Indianapolis, IN 46222-1997 Phone/fax: 317-955-6279
Email: [email protected]
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ACCEPTED MANUSCRIPT Abstract Regional fascial motion palpation is often incorporated by osteopathic practitioners to enable them to identify superior thoracic inlet (STI) myofascial somatic dysfunction motion patterns; however without standardized instruction, diagnostic outcomes may vary between examiners. This study proposes a protocol for diagnosing the STI motion
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pattern that standardizes examiner hand placement, palpatory discrimination, posture, and relative body positioning. The study design incorporated useful infrastructure recommended by the Fédération Internationale de Médecine Manuelle (FIMM) including protocol agreement steps prior to conducting the formal interexaminer reliability study with
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the goals of attaining >80% interexaminer agreement and kappa values >0.6 for each cardinal plane. The agreement phase comprised of testing 52 participants acquired agreements of 92.3% (rotation), 88.9% (translation), and 94.2%
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(sagittal). Kappa value testing involving an additional 82 participants obtained values of 0.65 (rotation), 0.59 (translation), and 0.70 (sagittal). Such kappa values endorse fair-to-excellent positive interexaminer correlations,
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demonstrating utility of this standardized palpatory protocol for STI myofascial dysfunctional diagnosis.
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INTRODUCTION
The development of information regarding diagnosis and treatment of regional fascial dysfunction owes a great deal to
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J. Gordon Zink D.O. and W. Lawson Ph.D. (Zink & Lawson, 1979).Their functional interpretation of such palpatory somatic findings influenced countless students and clinicians to include myofascial palpation of regional transitional zones when considering the significant relationship between fascia and lymphatic flow (Kuchera, 2011). Zink
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contemplated that as the body deals with trauma, whether it be minor constant trauma resulting from poor posture or major trauma such as that resulting from a motor vehicle accident, the connective tissues that make up the fascia, adjust
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in order to compensate for the external forces impacting the body. The modifications that occur in an attempt to maintain physical tensegrity can affect the function and thus eventually the structure of various tissues throughout the body (Swanson, 2013).
Though definitions vary, it is widely agreed that the functional superior thoracic inlet (STI) consists of the manubrium,
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ribs 1-2 (R1-2), and first 4 thoracic vertebrae (T1-4) (Kuchera, 2011). Somatic dysfunction of the STI directly affects the function of the superior thoracic outlet, which may, in turn, affect the brachial plexus, subclavian arteries and subclavian veins. Myofascial dysfunction of the STI can specifically obstruct the entire body’s lymphatic drainage into the subclavian
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veins as they pass through Sibson’s fascia (Chikly, 1997; Kuchera, 2011). Lymphatic stasis decreases the clearance of degraded waste products and reactive oxygen species created through inflammation and tissue damage, leading to an
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increase in recovery time from infections, accumulated edema, and other pathologies (Degenhardt & Kuchera, 1996).
The primary step in normalizing the structure and function of the STI in order to augment lymphatic drainage is to accurately diagnose the direction and pattern of fascial dysfunction so that it can be properly treated with manual techniques (Zink, 1977). Accurate identification of the direction and pattern of ease and bind to motion is essential in designing and carrying out many manual treatment interventions including direct and indirect myofascial release techniques (Johnson & Kurtz, 2003). Diagnosis is made by placement of the examiner’s hands on the STI and sequentially
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ACCEPTED MANUSCRIPT testing the regional fascial movement for somatic dysfunction using the palpatory end-feel of each motion barrier in each direction to determine the participant’s regional myofascial motion directional preference (Kuchera & Kuchera, 2012).
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Since it is common to teach the Zink regional fascial diagnostic approach in osteopathic medical schools, consistency in the conduct of palpatory technique at each regional site is an important, yet commonly overlooked, aspect for both teaching and clinical interpretation. Dr. Zink documented his approach to regional fascial diagnosis in the context of
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torsional and rotational fascial patterns that cause the restrictions in lymphatic flow (Kuchera, 2011; Zink, 1973). The current study was designed to validate a standardized process for fascial pattern motion diagnosis of the STI through
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creation of a specific palpatory protocol that can be used by any osteopathic practitioner to diagnose the fascial pattern in all 3 planes at this regional site. Achieving a strong interexaminer agreement within such a standardized protocol demonstrates reproducibility and the ability to attain a consistent diagnosis of myofascial somatic dysfunction that can then be acted upon through manipulative treatment. Such a protocol would provide a consistent foundation to effectively teach osteopathic and other manual practitioners how to diagnose the STI and the potential for use in future
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studies to document the efficacy of various techniques to modify this somatic dysfunction.
Interexaminer reliability studies are critical in evaluating a proposed protocol because they characterize the extent to
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which the data collected correctly represent the variables measured (McHugh, 2012). Simple percent agreement calculations are not accurate representations of interexaminer reliability because they do not account for chance
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agreement. The kappa statistical method developed by Jacob Cohen is currently regarded as the leading method used to test interexaminer reliability because it accounts for chance agreement, but it should still be compared against percent agreement since both are suggested as being critical aspects of healthcare studies (Chen et al., 2014).
There are multiple sources that evaluate kappa values in relation to the strength of agreement using differing schemes. Clinicians interpret kappa values for manual medicine studies one way (Patjin, 2004; see Table 1), while Altman uses an alternative interpretation of kappa values (Altman, 1990; see Table 2).
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PLACE TABLE 1 HERE
METHODS
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PLACE TABLE 2 HERE
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In the agreement phase of this study, anatomical landmarks such as the spinous process of T1, the sternoclavicular joints, and the pectoralis major muscles were agreed upon by the study team and used to help guide the examiner’s
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hand placement before diagnosing the fascial pattern of the STI. All examiners were third year osteopathic medical students (OMS-III) who had attended weekly lab sessions for two academic years with an osteopathic physicianeducator with 35+ years’ experience diagnosing and treating Zink fascial patterns in order to learn proper location of these landmarks for hand placement and skill in assessing the quality of the barrier end-feel associated with a variety of somatic tissues. This educator has extensive experience with interexaminer reliability studies and thus aided in the
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creation of a succinct and detailed protocol.
This study consisted of two stages: (1) Agreement Phase and (2) Interexaminer Reliability Kappa Study Phase. It was
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developed using the Fédération Internationale de Médecine Manuelle (FIMM) Protocol as a general infrastructure, which utilizes seven golden rules that are based on the different aspects and stages of a reproducibility study (Patjin,
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2004; see Table 3).
PLACE TABLE 3 HERE
Approval
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ACCEPTED MANUSCRIPT This protocol was approved by the Marian University Biomedical Institutional Review Board and conforms to the Declaration of Helsinki.
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Examiners
The participating examiners comprised two OMS-III students from Marian University College of Osteopathic Medicine. Both examiners received the same amount of osteopathic education under supervision from the same faculty. In order
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to eliminate evaluation bias, both examiners were blinded to the fascial patterns of the participants they examined and were not aware of the other examiner’s findings. A third OMS-III student from the same school and of the same level of
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competency was present as the official recorder to corroborate that the examiners followed every step of the agreed upon protocol throughout the diagnosis of participant’s fascial patterns and logged the results, while ensuring that both examiners remained blinded throughout the study. The recorder was also responsible for enrolling participants meeting
Participating subjects
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the criteria for analysis per protocol.
Osteopathic, nursing, and biomedical sciences students at Marian University aged 18-30 years were invited to enroll as
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participants in the study. Exclusion criteria included those with a history of surgery or injury involving the cervical or thoracic regions, connective tissue disease, skin disease, active infections, active muscle cramps or spasms, thoracic
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manipulation/massage within the past 5 days, or the inability to comfortably lie in the supine position for short lengths of time. Male participants were examined without shirt or shoes. Female participants were examined in sports bras. Lower body clothing was not discriminated. Earrings, necklaces and other jewelry in the thoracocervical region were removed from participants prior to evaluation. To avoid examiner fatigue, no more than 30 participants were examined on a given date. All participants were examined by both examiners.
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ACCEPTED MANUSCRIPT Fifty-two participants (18 females, 34 males) were tested during the Agreement Phase and 82 participants (41 females, 41 males) were tested during the Interexaminer Kappa (Κ) Statistic Phase.
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Obtaining interexaminer agreement
In the Agreement Phase of this study, 52 participants gave both verbal and written consent prior to being tested. Each participant was examined by the examiners separately with the order of examiners alternated to randomize the
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population to potential hysteresis change influences of the palpatory motion testing process of the first examiner on the second examiner’s STI fascial diagnosis. The precise examination steps to be used had been thoroughly discussed and
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agreed upon in advance after literature review and a series of five discussion meetings. The examinations took place on a standard flat osteopathic manipulation treatment (OMT) table that was adjustable for height. The subjects were examined with the examiner seated on an adjustable chair at the head of the OMT table set to be level with the examiner’s umbilicus.
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Participants were instructed to lie supine with their head on the side of the table closest to the examiner one-fist length away from the end of the table. The participants lay flat on the table with their feet together and their arms to their sides. They were instructed to lift both knees and hips fully off the table and then return to the supine position. The
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subject (see Figure 1):
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participants were instructed to lie still for one minute before placement of Examiner 1’s right and left hands on the
Digit 1 (thumb): posteriorly over the articulation between T1 transverse process and the first rib Digit 2: immediately inferolateral to the sternoclavicular (SC) joint Digits 3-5: evenly spread over the pectoralis major muscle at the level of the second rib
PLACE FIGURE 1 HERE
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ACCEPTED MANUSCRIPT *NOTE: It was agreed that should the examiner’s hands not be large enough to correctly place all digits, digits 2-5 were prioritized with digit 1 being naturally extended over the trapezius muscle. (This however was not necessary for the examiners and subject population involved in this study).
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Examiners positioned themselves with their dominant eye (as confirmed by the Miles Test (Miles, 1930)) directly in line with the subject’s longitudinal midline and with their feet flat on the floor. While keeping their elbows at approximately 135° and not allowing them to rest on the table, examiners used compressive forces to palpate deep to the skin and
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subcutaneous tissue until they felt the fascia over the first muscle layer, assuming that once soft-tissue is sensed the myofascial tissue is being palpated. Examiners then independently and sequentially tested for ease or bind barrier end-
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feels in each of the 3 cardinal fascial planes (rotational, translational, and then sagittal) and named the somatic dysfunction for the direction of ease (which direction the fascial barrier end-feels preferred to move). Results were verbally conveyed to the recorder without any feedback to the examiner and the first examiner left the room. Examiner 2 immediately entered upon Examiner 1 leaving and instructed the participant to again lift both knees and hips fully off the table and then return to the supine position. The participant was instructed to lie still for 1 minute before Examiner
RESULTS
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planes using the same protocol.
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2 tested the same participant without any knowledge of prior results, providing a separate diagnosis in each of the 3
Agreement results
Before collecting data to calculate a kappa value related to a specific protocol (Viera & Garrett, 2005), it is essential to first attain solid interexaminer agreement to ensure the protocol can achieve similar results between multiple examiners. As outlined by the FIMM Protocol, the examiners agreed to obtain > 80% interexaminer agreement of each plane of the regional myofascial diagnosis in the agreement phase before moving on to the interexaminer kappa statistic
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ACCEPTED MANUSCRIPT evaluation. If this goal was not reached, modifications would have been made to the protocol based on feedback from participants. However, this was not necessary as the protocol was successful in the Agreement Phase.
Fifty-two participants (18 females, 34 males) were examined over 2 consecutive days using the protocol and the results
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were as follows (see Table 4).
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PLACE TABLE 4 HERE
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Kappa statistic results
Calculation of a kappa value requires assigning outcomes as “positive” (+) or “negative” (-) for the test; in this case for each plane tested (Patjin, 2004). Examiners defined “positive” and “negative” as shown in Table 5.
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PLACE TABLE 5 HERE
Once data were collected, kappa statistic required calculation of the Observed Accuracy and Expected Accuracy. Both
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were then used in the Kappa Equation to determine the kappa value. The equations used to determine the kappa values
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are as follows:
Observed Accuracy =
Marginal Frequency =
Expected Accuracy =
#
#
#
#
+
#
#
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Kappa Value =
! "
# ! "
Participants were diagnosed using the agreed-upon protocol until each examiner had 10 positive diagnoses and 10
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negative diagnoses in each plane in order to further randomize and strengthen the data collected. Eighty-two participants (41 females, 41 males) were diagnosed using the palpatory diagnostic protocol with results as shown in
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Tables 6 to 8.
The rotational plane had an Observed Accuracy of 0.841, an Expected Accuracy of 0.546, and a Kappa value (Κ) of 0.65.
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This Kappa value is interpreted as having a high strength of interexaminer agreement by Altman and a good-to-excellent strength of interexaminer agreement by the FIMM Protocol (see Table 6).
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PLACE TABLE 6 HERE
The translational plane had an Observed Accuracy of 0.805 and an Expected Accuracy of 0.529, and Κ = 0.59. This Kappa value is interpreted as having a moderate strength of interexaminer agreement by Altman and a fair-to-good strength of
PLACE TABLE 7 HERE
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interexaminer agreement by the FIMM Protocol (see Table 7).
The sagittal plane had an Observed Accuracy of 0.866 and an Expected Accuracy of 0.546, and Κ = 0.70 (see Table 8). This Κ is interpreted as having a high strength of interexaminer agreement by Altman (see Table 9) and a good-to-excellent strength of interexaminer agreement by the FIMM Protocol (see Table 10).
PLACE TABLE 8 HERE
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ACCEPTED MANUSCRIPT DISCUSSION
The results of this study, achieved through testing of an equal number of healthy males and females (n = 82) using 2 different kappa value classification systems, demonstrating moderate-to-high agreement based on the Altman
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conditions (see Table 9) and fair-to-excellent agreement based on the FIMM clinical classification (see Table 10). Both interpretations indicated that this standardized study protocol effectively captures the diagnosis of the myofascial motion dysfunction patterns of the STI, in a manner that could be taught, learned, and applied to make a consistent
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diagnosis of regional STI fascial dysfunction. Assuring reproducible diagnosis of somatic dysfunction is an essential step in conducting subsequent research to determine if there are physiological or clinical outcomes achieved by removing
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that somatic dysfunction compared to controls where the dysfunction is documented to remain (Patjin, 2004).
PLACE TABLE 9 HERE
PLACE TABLE 10 HERE
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This interexaminer reliability study protocol considered the suggestions of Michael Seffinger, DO and colleagues in their systematic review of interexaminer reliability studies dealing with segmental spinal palpatory diagnostic techniques. In their interdisciplinary review the authors state the importance of minimizing bias, development of assessment
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instruments after careful consideration of prior guidelines, blinding the examiners, and realizing that regional range of motion is more reliable that segmental range of motion (Seffinger et al., 2004). The design of this study incorporated
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many of these suggestions as was minimized by enrollment of a gender-balanced population with adequate numbers of subjects having both left and right fascial directional preferences, development of the assessment tool occurred through a series of meetings discussing educational experiences and literature detailing the subject matter, examiners were ensured to be blinded to possible results by the recorder and randomized subjects, and regional range of motion was used through ease-bind motion testing in each cardinal plane of the myofascial structures over the entire STI rather than its individual segmental components.
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ACCEPTED MANUSCRIPT Systematic reviews of interexaminer reliability studies require a quality assessment tool that is consistently used to evaluate studies of diagnostic procedures. The diagnostic reliability appraisal tool Quality Appraisal of Reliability Studies (QAREL) was developed by Lucas and colleagues (Lucas et al., 2010). QAREL consists of an 11-item checklist that explores seven principles covering the spectrum of subjects, spectrum of examiners, examiner blinding, order effects of
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examination, suitability of the time interval among repeated measurements, appropriate test application and interpretation, and appropriate statistical analysis. Each consideration of the QAREL 11-item checklist was carefully
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PLACE TABLE 11 HERE
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reflected in the creation of this study’s interexaminer reliability protocol (see Table 11).
Furthermore, while heavily influenced by FIMM reproducibility study guidelines, not all of its recommendations were incorporated. While the FIMM guidelines suggest using 40 subjects for simple reproducibility studies (Patjin, 2004), a larger number was used in this study in order to better achieve a significant population size in order to further test the reproducibility of this study’s standardized technique in each of the 3 cardinal planes during the same study. FIMM
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guidelines suggest each examiner send 10 positive and 10 negative subject outcomes in each tested finding to the other examiner. Such a study design minimizes maldistribution of outcomes that could bias the examiners (Patjin, 2004). However, no matter the number of subjects tested, an important statistical consideration is to keep the number of
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positive and negative outcomes in each tested arm as close to equal as possible. In the “real world” distribution, the present study did not use equal numbers of positive and negative outcomes in each plane, leading the authors to believe
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that the kappa numbers might be even higher had this portion of the FIMM guidelines been followed. While examiners in this study tested subjects until at least 10 positive and 10 negative outcomes were achieved in each plane and the current data could be used to go back and use each examiner’s first 10 positive and 10 negative outcomes before sending the subject to the other examiner, authors did not do so as this would not retain other aspects of the 3 plane analysis.
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ACCEPTED MANUSCRIPT When diagnosing the STI fascial patterns, this study’s protocol did not set a limit on how many times an examiner could test each direction to find the direction of ease. Not deciding on a maximum number of times each direction was to be tested could have changed the hysteresis patterns inherently present within each test subject (Barnes et al., 2013). This may have affected the second examiner’s results, as the fascial patterns could have significantly changed after Examiner
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1’s diagnosis (Kuchera et al., 2010). In future studies, examiners should limit their movements in each direction when testing subjects; this could potentially enhance interexaminer reliability measures further. While there was not a set number of palpatory movements by examiners under this protocol, each examiner in this study was consistent in
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attempting to limit their palpatory movements in order to limit hysteresis changes while attaining a diagnosis.
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The hand placement of the examiners could be difficult to standardize depending on examiners’ hand size. In the present study, both examiners were able to place their hands on the appropriate landmarks without difficulty. However, if an examiner’s hands are too small to reach all landmarks, the diagnosis may be affected. Additionally, every participant has a different body type, which would also add a variable that is difficult to control with the protocol as described in the current study. While the study’s protocol incorporated a proposed alternative in such a situation, this
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study did not encounter the situation, so mismatched examiner-subject size issues were not tested in this study.
Due to prior experience of testing a large number of subjects at once in which examiner fatigue became a possible factor
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affecting the accuracy of their diagnosis, the researchers in the current study compensated by testing subjects over multiple days and testing no more than 30 subjects in a day. That number was arbitrarily determined and future studies
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may warrant fewer subjects being evaluated in a given session.
Future studies could expand this type of interexaminer reliability investigation in a variety of ways. Dr. Zink and those using his approach to evaluating regional palpatory characteristics studied more than just the STI region when discussing fascial motion patterns; future studies could evaluate fascial patterns in the cervico-cranial, thoraco-lumbar, or lumbosacral regions. Use of a fixed camera and software that analyzes photographs of examiners testing the subjects could not only assist in determining whether the examiners agree on a directional diagnosis, but also quantify (in mm) to what
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ACCEPTED MANUSCRIPT specific degree they find agreement. This would allow for more precise measurements that give more detailed and quantifiable data about the diagnosis of the fascial patterns.
It may also be worthwhile to examine if this study’s protocol yields equally successful results with examiners who are
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allopathic medical students or physicians, chiropractors, physical therapists, and other practitioners not formally trained to palpate for somatic dysfunction. As manual medicine becomes increasingly accepted in the medical community, practitioners of all specialties and educational backgrounds concerning the spectrum of manual therapies should have
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simple and effective methods of learning these important skills. It is the authors’ hope that this palpatory protocol provides a strong foundation towards developing such methods and expanding the reach of palpatory diagnosis and use
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of manual care for patient benefit.
CONCLUSION
Overall, the results of this study indicate that the palpatory protocol successfully standardized the diagnosis of STI
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somatic dysfunction. With further study and modification with the suggestions in this discussion, the protocol could be improved to possibly obtain even higher interexaminer agreement for all 3 fascial planes. The authors hope that this interexaminer reliability study is replicated in the future and eventually used to standardize regional fascial diagnosis
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education and clinical interpretations. A standardized protocol, such as the one created in this study, can be an effective tool to teach analysis of regional myofascial palpatory patterns. The authors hope that this protocol for the regional
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myofascial diagnosis of the STI, along with protocols for many other palpatory techniques, will continue to be researched in the future and lead to the advancement of the evidence-base used in teaching, interpreting and clinically applying manual therapeutics.
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ACCEPTED MANUSCRIPT Acknowledgements The authors gratefully acknowledge Jeffry Kellogg, Ph.D. (Professor, Department of Psychology; Marian University; Indianapolis IN, USA) for his statistical review and William A. Kuchera, DO, FAAO (Emeritus Professor, Department of Osteopathic Manipulative Medicine; AT Still University – Kirksville College of Osteopathic Medicine; Kirksville MO, USA)
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for Figure 1 artwork. The authors also wish to express appreciation to the subjects for their willing participation.
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REFERENCES
Altman DG 1990 Practical statistics for medical research. CRC Press, Cleveland, OH.
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Barnes PL, Laboy F, 3rd, Noto-Bell L, Ferencz V, Nelson J, Kuchera ML 2013 A comparative study of cervical hysteresis characteristics after various osteopathic manipulative treatment (OMT) modalities. J Bodyw Mov Ther 17, 89-94. Chen H, Hailey D, Wang N, Yu P 2014 A review of data quality assessment methods for public health information systems. Int J Environ Res Public Health 11, 5170-5207.
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Chikly B 1997 Who discovered the lymphatic system? Lymphology 30, 186-193.
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Degenhardt BF, Kuchera ML 1996 Update on osteopathic medical concepts and the lymphatic system. J Am Osteopath Assoc 96, 97-100. Johnson SM, Kurtz ME 2003 Osteopathic manipulative treatment techniques preferred by contemporary osteopathic physicians. J Am Osteopath Assoc 103, 219-224. Kuchera ML, Casella F, Nelson J, Ferencz V, Myers NE 2010 Effect of a prior anterior superior iliac spine compression testing on second assessor findings: Implications for inter-examiner reliability testing. Manuelle Medizin 48, 369.
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Kuchera ML 2011 Lymphatics approach, in: Chila A (Ed.), Foundations of Osteopathic Medicine, 3rd ed. Lippincott Williams & Wilkins, Philadelphia, PA pp. 786-808. Kuchera ML, Kuchera WA 2012 Osteopathic considerations in HEENT disorders. Greyden Press, Dayton, OH.
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Lucas NP, Macaskill P, Irwig L, Bogduk N 2010 The development of a quality appraisal tool for studies of diagnostic reliability (QAREL). J Clin Epidemiol 63, 854-861. McHugh ML 2012 Interrater reliability: the kappa statistic. Biochem Med (Zagreb) 22, 276-282.
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Miles WR 1930 Ocular dominance in human adults. J Gen Psych 3, 412-430. Patjin J 2004 Reproducibility and validity studies of diagnostic procedures in manual/musculoskeletal medicine, 3rd ed. International Federation for Manual/Musculoskeletal Medicine Scientific Committee. Seffinger MA, Najm WI, Mishra SI, Adams A, Dickerson VM, Murphy LS, Reinsch S 2004 Reliability of spinal palpation for diagnosis of back and neck pain: a systematic review of the literature. Spine (Phila PA 1976) 29, E413-425. Swanson RL, 2nd 2013 Biotensegrity: a unifying theory of biological architecture with applications to osteopathic practice, education, and research--a review and analysis. J Am Osteopath Assoc 113, 34-52. Viera AJ, Garrett JM 2005 Understanding interobserver agreement: the kappa statistic. Fam Med 37, 360-363.
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ACCEPTED MANUSCRIPT Zink JG 1973 Applications of the osteopathic holistic approach to homeostasis. Am Acad of Osteo Yearb, 37-47. Zink JG 1977 Respiratory and circulatory care: the conceptual model. Osteopath Ann 5, 108-112.
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Zink JG, Lawson WB 1979 An osteopathic structural examination and functional interpretation of the soma. Osteopath Ann 7, 12-19.
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ACCEPTED MANUSCRIPT Table 1. FIMM Protocol Kappa Value Interpretation Strength of Agreement
Κ < 0.4
Poor
Κ =0.4 – 0.6
Fair to Good
Κ > 0.6
Good to Excellent
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Kappa Value (Κ)
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ACCEPTED MANUSCRIPT Table 2. Altman Kappa Value Interpretation Strength of Agreement
Κ < 0.2
Poor
Κ =0.21 – 0.4
Fair
Κ =0.41 – 0.6
Moderate
Κ =0.61 – 0.8
High
Κ =0.81 – 1.0
Very High
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Kappa Value (Κ)
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ACCEPTED MANUSCRIPT Table 3. FIMM Protocol Seven Golden Rules (Patijn, 2004) FIMM Protocol Seven Golden Rules Create a clear logistic and responsibility structure for the reproducibility study.
Rule #2
Always create a training period before performing a reproducibility study.
Rule #3
Always create an overall agreement period before performing a reproducibility study.
Rule #4
Always use a blinding procedure in a reproducibility study.
Rule #5
Always define the population from which the subjects are selected.
Rule #6
Always mention the definition of the source population, the selection method, the blinding procedure,
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Rule #1
the definition of test procedure and test results in materials and methods when publishing.
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Always show a 2 x 2 contingency table with the prevalence and overall agreement figures in results
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when publishing a reproducibility study.
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Rule #7
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ACCEPTED MANUSCRIPT Table 4. Agreement Phase Results
Number Agreement Percent Agreement
48/52
92.3%
Translational Plane
46/52
88.9%
Sagittal Plane
49/52
94.2%
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Rotational Plane
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ACCEPTED MANUSCRIPT Table 5. Positive & Negative Test Outcome Assignments for Kappa Testing
Rotational Plane Translational Plane Sagittal Plane
right
right
anterior
Negative (-)
left
left
posterior
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Positive (+)
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ACCEPTED MANUSCRIPT Table 6. Rotational Plane Kappa Value Testing Outcomes Rotational Plane
Examiner 1
Positive (+) Negative (-)
47
Negative (-)
5
8
22
AC C
EP
TE D
M AN U
SC
Positive (+)
RI PT
Examiner 2
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ACCEPTED MANUSCRIPT Table 7. Translational Plane Kappa Value Testing Outcomes
Translational Plane
Examiner 1
Positive (+) Negative (-)
43
Negative (-)
9
7
23
AC C
EP
TE D
M AN U
SC
Positive (+)
RI PT
Examiner 2
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ACCEPTED MANUSCRIPT Table 8. Sagittal Plane Kappa Value Testing Outcomes
Sagittal Plane
Examiner 1
Positive (+) Negative (-)
48
Negative (-)
5
6
23
AC C
EP
TE D
M AN U
SC
Positive (+)
RI PT
Examiner 2
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ACCEPTED MANUSCRIPT Table 9. Kappa Value Results Interpretation by Altman
Kappa Interpretation Kappa Value (Κ) Strength of Agreement
0.65
High
Translational Plane
0.59
Moderate
Sagittal Plane
0.70
High
AC C
EP
TE D
M AN U
SC
RI PT
Rotational Plane
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ACCEPTED MANUSCRIPT Table 10. Kappa Value Results Interpretation by FIMM Protocol Kappa Interpretation Kappa Value (Κ) Strength of Agreement
0.65
Good to Excellent
Translational Plane
0.59
Fair to Good
Sagittal Plane
0.70
Good to Excellent
AC C
EP
TE D
M AN U
SC
RI PT
Rotational Plane
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ACCEPTED MANUSCRIPT Table 11. QAREL 11-Item Checklist Quality Assessment Tool for Diagnostic Reliability Studies
Item #9 Item #10 Item #11
RI PT
Item #7 Item #8
SC
Item #6
M AN U
Item #5
TE D
Item #3 Item #4
EP
Item #2
AC C
Item #1
QAREL Checklist Was the test evaluated in a sample of subjects who were representative of those to whom the authors intended the results to be applied? Was the test performed by raters who were representative of those to whom the authors intended the results to be applied? Were the raters blinded to the findings of other raters during the study? Were the raters blinded to the own prior findings of the test under evaluation? Were the raters blinded to the results of the accepted reference standard or disease status for the target disorder (or variable) being tested? Were the raters blinded to clinical information that was not intended to be provided as part of the testing procedure or study design? Were the raters blinded to additional cues that were not part of the test? Was the order of examination varied? Was the stability (or theoretical stability) of the variable being measured taken into account when determining the suitability of the time-interval between repeated measures? Was the test applied correctly and interpreted appropriately? Were appropriate statistical measures of agreement used?
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ACCEPTED MANUSCRIPT
AC C
EP
TE D
M AN U
SC
RI PT
Figure 1. Hand Placement for Superior Thoracic Inlet Palpatory Diagnosis (Myofascial Motion Preference) Protocol. Sequentially applied motion for: (1) Rotation preference; (2) Translational (sidebending) preference; (3) Sagittal (forward-backward bending) preference.
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