SSA: Detecting Dysphagia in Acute Stroke

ACKNOWLEDGMENTS

Many professionals contributed to the completion of this research effort. I would like to thank my supervisor Professor David Howard Degree Programme Director of School of Education Communication and Language Sciences in the University of Newcastle in United Kingdom; he extended my knowledge of statistical analysis and design issues. My thesis committee has been flexible, informative, and extremely helpful. I would thank Dr. Deborah James, Dr. Nick Miller and Ms. Gillian Cavagan the Office Manager of my school department. I am grateful for the efforts of Drs. Essam Al- Zimaity the head of the ENT Department in King Khalid National Guard Hospital in Jeddah Saudi Arabia for his help and for letting me collecting the data. I am thanking Dr. Ashraf Abu alaiz the speech language pathology consultant and all my friend and colleague for there help and support; they have been the front line in this effort. I am thanking all the Neurology department in King Khalid Hospital specially the nurses and the clinical nutrition for their help.

ABSTRACT

        Dysphagia is common after acute stroke and there is a risk of aspiration pneumonia and other complications.  The early detection of dysphagia in such patients reduces such complications, hospital stay, and overall healthcare expenditures.  The objective of this study was to detect and manage dysphagia in the first few days after stroke by formal swallowing assessments.  A pre- and post-intervention study Standardised Bedside Swallowing Assessment (SSA) was performed using a standardised bedside swallowing assessment (SSA) at the neurology ward in King Khalid National Guard Hospital, Jeddah, Saudi Arabia.  The ethical committee of the hospital approved the study.

        The study involved forty consecutively admitted patients with acute. The results mainly indicated that patients with dysphagia had a 6-fold higher risk of developing a chest infection compared to those without swallowing problems.  The SSA was found to be a simple, safe, and effective procedure in the detection of dysphagia in the first few days after stroke.  This study supports the use of the SSA by ward speech pathologists as a screening tool for dysphagia in patients with acute stroke.

INTRODUCTION

Problem and its Background

            Acute stroke is one of the leading conditions afflicting at least 100000 individuals in UK annually (Smithard et al., 1998, p.99). Such condition progress to various impairments and one of that is dysphagia, which is the difficulty of swallowing. The condition of dysphagia has been found to affect 43% of hemispheric stroked patients (Gordon, Langton-Hewer, Wade, 1987). Dysphagia has well-dcumented risks; hence, risking almost half of the population to various complications, such as with frequent aspiration and upon progression such as aspiration leading to chest infections that may be life-threatening (Schmidt et al., 1994; Kidd, 1995), and dehydration and malnutrition appearing on the latter phase of condition (Kidd, 1995; Barer, 1989). There is enough evidence to suggest that the early detection of dysphagia in patients with acute stroke reduces such complications, reduces hospital stay and overall healthcare expenditures (Martino, Pron, Diamant, 2000). Clinical screening, specifically Standardized Swallowing Assessment (SSA) (Perry & Love, 2001), has been one of the major breakthroughs of diagnostic procedures that endeavors swallowing-difficulty diagnosis.  Several studies have described the utility and validity of the SSA (Smithard et al, 1997; Schmidt et al., 1994; Ellul & Barer 1993) compared with other methods of swallowing assessments as well as its inter-rater reliability (Smithard et al, 1997; Schmidt et al., 1994; Ellul & Barer 1993).

Setting of the Study

The study was conducted in the neurology ward of the King Khalid National Guard Hospital, Jeddah, Saudi Arabia.  The study was performed after the approval of the ethical committee of the hospital.  Medical and nursing team notes were assessed and the results were compared with independent assessment of swallowing safety made on days 1 and 7 by the speech language therapist using SSA.

Scope and Limitation

The objective of this study is the detection and management of dysphagia in the first few days after stroke by a pre- and post-intervention study using a standardized bedside swallowing assessment.  Primarily, the study aims to validate the effectiveness of SSA in the detection of swallowing impairment, dysphagia. It also employs the gathering of literature review that illustrates the data organization of normal physiology in swallowing mechanism, complications that may arise in impairment of such process, and the abnormalities involved, specifically dysphagia. In addition, the study utilizes these data in order to provide differentiation of the presenting health problem against the standard physiological pattern of the body as directed in the review of literature. The following are the imposed objectives of the course research:

1. To be able to provide the supporting data that validate if the procedure SSA is an effective diagnostic means for Dysphagia detection specifically for Acute stoke as supported by validated evidences and specifications that clearly depict the effectiveness of such procedure.
2. To be able to represent the methodology involved as well as the fundamental components, such as statistics, implications, and inferences that are involved in methodology.
3. To be able to provide the identified gaps and problems identified during the course research processes, particularly data validation, statistical discrepancies and problems in methodology.

Health and Clinical Management

The occurrence of any chest infection was diagnosed and documented by the medical team.  All nursing personnel in the neurology team have taken short courses in swallowing rehabilitation (rehabilitation with nasogastric tube or with gastrostomy tube) along with qualified speech language therapists who perform the swallowing assessment.  The neurology team carried out standardized medical assessments (to classify the stroke and to estimate the severity).  The Ear, Nose & throat (ENT) team assessed the vocal cord movement and noted if there are any possible gaps in the vocal cord or paralyses.  The Speech Language Pathologists (SLP) performed the three stages of Standardized Bedside Swallowing Assessment and tongue movement assessment.

LITERATURE REVIEW

Acute stroke

        Stroke is a common condition and it has been estimated that it affects about 5–8 people in every 1000 over 25 years of age or 47 in every 1000 over 55 years in the community (Perry, 2001). Stroke can produce a wide variety of neurological impairments in the acute stages.  These effects include: swallowing disorders, lack of postural control, upper-limb dysfunction, visual, cognitive, perceptual, and communication impairments and dyspraxia (Perry, 2001).  These problems can by itself or in combination, leads to malnutrition, prolonged hospital inpatient stay and increased complication, and mortality rates (Perry, 2001).

        Swallowing physiology can be affected by cerebral, cerebellar, or brain stem strokes.  In cerebral lesions, the voluntary control of mastication and bolus transport during the oral phase can be affected (Zald & Pardo 1999; Daniels et al., 1997) or it can impair swallowing control by affecting cognitive functions like concentration or selective attention (Ertekin, 2000).  Cortical lesions involve the pre-central gyrus that leads to contra-lateral impairment in facial, lip, and tongue motor control, and contra-lateral compromise in pharyngeal peristalsis (Veis & Logemann, 1985).

While computerized tomography of the brain in stroke patients with dysphagia commonly shows unilateral lesions, MRI may frequently reveal lesions in the nonsymptomatic hemisphere (Nilsson et al., 1998).

Although brain stem strokes are less common than cortical lesions, they cause the greatest swallowing difficulties by affecting the sensations of the mouth, tongue, and cheek, timing in the trigger of the pharyngeal swallow, laryngeal elevation, glottic closure, and cricopharyngeal relaxation (Ertekin, 2000; Martino, 2001).  Whatever the location of the lesion, stroke occurs more commonly in the elderly (Devroey, 2003), and the normal age-related swallowing changes worsens the dysphagia due to stroke.

Aspiration

            Dysphagia with aspiration is common in the early period following acute stroke. The prevalence of dysphagia in patients with acute non-hemorrhagic stroke has been found to be 28% to 45% (Muray, 1996 p.6). Among stoke patients with dysphagia, one study (Chen et al., 1990) found mild dysfunction. In 39%, moderate dysfunction in 50%, and severe dysphagia in 11% (Bogousslavsky and Caplan, 2001 p.345). The risk of aspiration has long been viewed as a significant complication of dysphagia; however, the ability to predict aspiration pneumonia based the presence of dysphagia has not beet conclusively demonstrated (Langmore, 2001 p.204).

Two additional studies of dysphagia after stroke have been reported. In one study (Smithard, O’Neill, England, 1997), 121 consecutive stroke patients admitted within 24-hours of onset were evaluated prospectively. This study found that 51% of patients had evidence of a dysphagia on admission (Smithard, O’Neill, England, 1997).  Another large study (Mann et. Al., 1999) of 128 stroke patients also found that on admission 51% had some evidence of dysphagia. Considering all of these studies together, it seems reasonable to conclude that some degree of dysphagia will be present in approximately 50% of all stroke patients. This makes dysphagia a common as well as a significant abnormality (Bogousslavsky and Caplan, 2001 p.345).

Chest Infections

Malnutrition

Dehydration

Assessment of swallowing

        Given the high prevalence of swallowing difficulties present at the time of admission to hospital and the consequent risk of aspiration, an assessment needs to be undertaken at the bedside and at the time of admission by non-specialists (doctors and nurses).  A full assessment consists of a clinical bedside assessment, and indication for further complex investigative techniques.

The clinical bedside assessment (BSA)

        A speech and language therapist who performs an accurate and timely BSA can help to detect patients with dysphagia who are at risk of aspiration.  The BSA includes examination of the anatomy and neurology of swallowing, and the swallowing mechanism.  In many studies, a simple swallow test of a fixed volume of water to assess the ability to swallow, timed or untimed, has been used, and has been correlated to videofluoroscopy findings.  Some common signs that suggest the presence of aspiration are: reduced level of consciousness, weak cough, dysphonia, wet/gurgly voice, choking/coughing on swallowing 5 ml water and an increased time taken to swallow a fixed volume (50–90 ml) of water.  However, none of these signs has shown sensitivity or specific enough to predict the presence of aspiration (Ramsey, Smithard, Kalra, 2002).

        Smithard et al., 1996 examined the relationship between dysphagia and both outcome and complications after acute stroke using bedside assessment and videofluoroscopic examination.  The authors prospectively studied 121 consecutive patients admitted with acute stroke.  While a physician performed a standardized bedside assessment, videofluoroscopy, which was blinded to this assessment, was also done within 3 days of stroke onset and within a median time of 24 hours of the bedside evaluations.  A record was made on the presence of aspiration, and the main outcome measures were mortality, functional outcome, length of stay, place of discharge, occurrence of chest infection, nutritional status, and hydration.

        The results indicated that patients with dysphagia on bedside assessment had a higher risk of chest infection and a poor nutritional state.  The presence of dysphagia was also associated with an increased risk of death, disability, length of hospital stay, and institutional care.  The study also found that with other factors taken into account, dysphagia remained as an independent predictor of outcome only with regard to mortality.  The use of videofluoroscopy for the detection of aspiration did not add to the value of bedside assessment.  From this study, the authors concluded that bedside assessment of swallowing is useful to identify those patients who are at risk of developing complications.  The authors also questioned the value of routine screening with videofluoroscopy in order to detect aspiration (Smithard et al., 1996).

Gag reflex

        Historically, the gag reflex was used as an assessment method to know the ability to swallow safely.  This was based on studies of patients many months after the onset of stroke (Ramsey, Smithard, Kalra, 2002). However, such procedure has been proven unreliable at some instances, such as unconscious clients, etc. (Tohara et al., 2003).

Nasal endoscopy

        Nasal endoscopy has been used in recent years to study the processes involved in swallows.  It can be used at the bedside, and does not expose the patient to radiation.  If the endoscope is attached to a video recorder, the study can be viewed and reported at a later date.  Stimulation of the mucosa over the area supplied by the recurrent laryngeal nerve gives information regarding pharyngeal motility.  The presence of aspiration can be indirectly assessed by residue seen in the larynx and pharynx (Ramsey, Smithard, Kalra, 2002).

Fluoroscopy

        The traditional barium swallow for the evaluation of pharyngeal swallow has been replaced by videofluoroscopy, which is a modified barium swallow.  Videofluoroscopy is considered to be the gold standard in the assessment of the swallowing mechanism.  The procedure allows the study of all three phases of the swallow in one examination.

        The examination is performed in both lateral and anteroposterior projection views, which allow imaging of the oral, pharyngeal and oesophageal phase, and assess symmetry in the anteroposterior plane.  In order to ensure that aspiration is not missed, swallows are required in bedside assessment.  The speech and language therapist and radiologist can evaluate the recorded videotape of the procedure at a later date.  Videofluoroscopy provides a dynamic image of the swallow, which helps to increase the diagnostic accuracy of swallowing difficulties and improve the treatment of dysphagia.  Videofluoroscopy also allows the assessment of the response to therapeutic compensatory maneuvers or swallowing techniques.  Since small volumes of high-density barium (which can be thickened, thinned or added to differing food consistencies to stress the swallow) are used, videofluoroscopy helps in the detection of even the smallest amount of aspiration (Ramsey, Smithard, Kalra, 2002).

Pulse oximetry

        Pulse oximetry is a noninvasive method of investigating bedside swallow (Ramsey, Smithard, Kalra, 2002).  Several mechanisms have been suggested, and proposed that aspiration causes reflex bronchoconstriction and a subsequent ventilation-perfusion imbalance, which leads to hypoxia and desaturation.  Others have suggested that abnormal swallowing leads to poor breathing and ventilation perfusion mismatching because of reduced inspiratory volumes (Ramsey, Smithard, Kalra, 2002).

        The combination of pulse oximetry along with other assessment tools including videofluoroscopy and bedside assessment can help in the detection of aspiration in patients after an acute stroke (Smith et al., 2000).  It has been found that a desaturation of equal to or greater than 2% appeared to detect aspiration with or without penetration with a high sensitivity value (87%).  Aspiration with or without penetration predictive values for pulse oximetry were better when paired with bedside assessment (95%)  (Smith et al., 2000).

Fiberoptic endoscopic examination of swallowing (FEES)

        FEES is a highly sensitive method for the detection of aspiration.  FEES can provide information on the anatomy, the swallowing process, pharyngeal motility, and presence of any sensory deficits.  Although FEES does not allow the direct visualization of aspiration, the presence of aspiration is confirmed by noting the presence of residue left after swallowing or by noting the ejection of material out of the trachea after coughing.  The FEES assessment can be conducted at the bedside, and can even be videotaped if required.  The procedure is generally safe and well tolerated by the patient (Ramsey, Smithard, Kalra, 2002).

Water swallow test

        In the past, many studies have evaluated the effectiveness of water swallow testing; however, these studies have used small (5–10 ml) volumes of water.  This may not have been adequate to identify the presence of any swallowing dysfunction.  In contrast to this, the use of large (50–150 ml) volumes of water may improve the diagnostic accuracy in identifying swallowing dysfunction but it has its attendant complications (Daniels et al., 1997.)

        Selina et al., 2001, aimed to evaluate the validity of the 50-ml water swallow test and the

use of oxygen desaturation on pulse oximetry in identifying patients who were at risk of aspirating with FEES.  They also observed the result of combining both in the screening test.  The results of the study indicated that when compared with the FEES assessment, the oxygen desaturation test had a sensitivity of 76.9%, specificity of 83.3%, positive predictive value of 83.3%, and negative predictive value of 76.9%.

        The 50-ml water swallow test had a greater sensitivity of 84.6% but a lower specificity of 75% compared with the oxygen desaturation test.  It had a positive predictive value of 78.6% and a negative predictive value of 81.8%.  However, the combination of the two tests into one test of “bedside aspiration,” resulted in a highly significant value, with a sensitivity of 100%, a specificity of 70.8%, a positive predictive value 78.8%, and negative predictive value 100%, respectively.  The combined test also enabled the detection of four silent aspirators, which was missed in the 50-ml water swallow test.  The highest degree of agreement with FEES was found with the “bedside aspiration” test.

        From this, the authors concluded that the combination of 50-ml water swallow test and the oxygen desaturation test (“bedside aspiration” test), can identify patients with visible swallowing difficulties and those patients who are silently aspirating.  Once these patients are identified, they can be referred for a more definitive modified barium swallow assessment or FEES.  In addition, the authors also observed that patients who are at low risk of aspirating would be able to return to oral feeding earlier.

Other methods

        Cervical auscultation of the mechanical and/or respiratory components of swallowing, combined with bedside testing, has been compared with VF and revealed significant agreement for detection of aspiration, which can be performed at the bedside.  Lateral cervical soft tissue radiographs have been used after swallowing contrast.  Ultrasonography is safe and moderately portable.  Pharyngeal or esophageal manometry can provide useful information, particularly when combined with VF.  Other methods tried include scintigraphy and electromyography (Ramsey, Smithard, Kalra, 2002).

Drawbacks of swallowing assessment methods

        BSA takes time, and even then may not detect all cases of aspiration.  Later studies on gag reflex, which assessed the ability of stroke patients to swallow during the first few days and weeks following stroke have not demonstrated any significant efficiency of this method.  It has been found that the gag reflex was absent in half of fit elderly people and in one-third of young volunteers, despite all of them having a normal and safe swallow (Tohara et al., 2003).  In addition, no relationship has been demonstrated between aspiration detected on videofluoroscopy and the presence or absence of a gag reflex.  Although nasal endoscopy, gives good three-dimensional views of the pharynx and larynx, it does not offer much information with regard to the oral stage, the function of the upper oesophageal sphincter, or pharyngeal motility (Tohara et al., 2003).

        Many studies have examined the effectiveness of bedside examination for detecting aspiration.  Tests like water-swallowing test and Repetitive Saliva Swallowing Test (RSST) are either not accurate or requires skilled examiners (Tohara et al., 2003).  In addition, in the water-swallowing test, the use of large volumes of water can potentially lead to the aspiration of large amounts of water, and thereby, may result in medical complications (Daniels et al., 1997).

        Fiberoptic endoscopic examination of swallowing (FEES) is highly sensitive for detecting aspiration but cannot provide all the details of swallow physiology.  FEES also requires sophisticated instrumentation and a skilled examiner (Tohara et al., 2003).

        Videofluoroscopic swallowing examination (VFSE) has traditionally been the gold standard, because of its ability in assessing oral, pharyngeal, and cervical esophageal stages of swallowing.  However, there are issues of transportation and radiation (Tohara et al., 2003).  VFSE is also not a natural procedure since it examines swallowing in ideal circumstances, in an upright posture and using boluses that are not similar to normal food and liquid intake (Tohara et al., 2003).  The procedure also requires coaching (Tohara et al., 2003), and other drawbacks of VFSE include: lack of standardization of volumes, consistencies or textures of food/fluids used, or anatomical landmark movements or motion duration used as criteria of normal swallowing (Perry, 2001).  The inter-rater reliability of reporting is poor and the relationship between abnormalities identified on VFSE and patient outcomes is unclear (Perry, 2001).  Both FEES and VFSE are also expensive (Tohara et al., 2003).

        Many screening tests, like the 3-oz. water test, involve giving the patient designated amounts of water and instructing the patient to swallow continuously or as rapidly as possible (the timed swallow test).  If the patient aspirates a significant amount, these tests can potentially introduce a large amount of water into the patient’s airway (Smithard, O’Neill, England, 1997).  Screening tools like pulse oximetry is useful but its efficacy is not proven (Perry, 2001).  Research into sound patterns produced by cervical auscultation is still ongoing and the reliability of the technique is not very clear.

        Lateral cervical soft tissue radiographs have problems with head posture control, and are difficult to report for the inexperienced person.  Ultrasonography has the disadvantage that most ultrasound probes are too small to visualize the whole swallow and are limited to non-bony areas.

        Techniques like pharyngeal or esophageal manometry, scintigraphy and electromyography have the disadvantages that they cannot be used at the bedside, are invasive, and require specialized staff and equipment; because of these reasons, these techniques have mainly remained research tools (Ramsey, Smithard, Kalra, 2002).  Therefore, it is clear that many screening tools have disadvantages.

          Screening tools also need to be: sensitive i.e., able to detect `risk’; specific i.e., able to show negative results where the patient is not `at risk’; able to give consistent results even when used by different people; easy to use; acceptable to patients; be cost effective (Perry, 2001).

        In general, the sensitivity of available screening tests, procedures to identify aspiration and their specificity in identifying patients who do not aspirate ranges between 50% to 80%, and if their sensitivity is high, the specificity tends to be low (Logemann, Veis, Colangelo, 1999).  A test should have high specificity (low false positive rate) and high sensitivity (low false negative rate) for it to be clinically useful (Smithard, O’Neill, England, 1997).

SSA

        Currently, SSA is the only screening tool, which has published reliability data using nurses, and it has shown good results with minimal training (Perry & Love, 2001).  A comparison of various screening tools (SSA, BSA, and timed test) in consecutively admitted stroke patients has shown that SSA has the lowest percentage of unassessable patients, which may indicate the relative clinical utility of SSA (Perry, L, Love, 2001).

        Perry, 2001 conducted a longitudinal prospective survey to review the evidence for dysphagia screening methods in patients with acute stroke and identify, implement and establish the sensitivity and specificity of SSA by nurses.  A multi-professional team of doctors and nurses documented patients admitted consecutively with a diagnosis of acute stroke.

        Swallowing function was screened within 24 hours of admission, and total of 123 patients were screened.  For 33 patients, details on the method of screening were not available.  For 64 patients, the principle method of screening was the Standardized Swallowing assessment-based tool.  Gag reflex alone was used for six patients and for two patients, the gag plus water was used; 18 cited checking the ability to swallow water.  While judgments about the ability to swallow water were made by both doctors and nurses (with one supervised episode excepted), the SSA was used only by the nurses.  A comparison with summative clinical judgment of swallow function was made on the basis of 68 completed screening episodes by independently competent nurses.

        The results revealed a sensitivity of 0.97 and specificity of 0.9 for detection of dysphagia, with positive and negative predictive values of 0.92 and 0.96.  These values were better than gag reflex performance, and thus, support the use of the SSA by competent ward nurses as a screening tool for dysphagia in patients admitted with acute stroke.

        In a second study, the same author, in a longitudinal prospective survey, assessed the performance of SSA in detail, and specifically, looked at: the results of the screening tool if the effects of chance are eliminated; whether all components of the tool required to achieve this; if screening with the Standardized Swallowing Assessment affect patient outcomes.  This study also involved the multi-professional documentation of two groups of 200 consecutive admissions with clinical diagnosis of acute stroke.

        A comparison with summative clinical judgment of swallow function was made on the basis of 68 completed screening episodes by independently competent nurses (with the effects of chance removed).  The results revealed a good agreement with summative clinical judgment of swallow function.  It was also found that not all components of the tool were required; analyses suggested elimination of three variables.  The screening initiative contributed to improved patient outcomes.  This study, therefore, showed that SSA has high levels of accuracy in identifying the presence and absence of dysphagia, even when the effects of chance are removed.  Completion of the full education and training programme was required for competency and accuracy.

        Westergren, 2006 performed a systematic review focusing on noninvasive, noninstrumental screening methods to detect eating difficulties following stroke.  A MEDLINE search was used to identify articles for the review.  The inclusion criteria included papers describing primary research involving screening for eating difficulties and dysphagia/aspiration in stroke patients and papers on invasive screening methods (except pulse oximetry) were excluded.  The 2 evaluated methods of screening for eating difficulties both involved “eating observation” items (arm movement, lip closure, transport of food to the mouth, and leakage).

        The author reviewed articles on the SSA and it was found to have variable sensitivity, specificity, positive predictive value, and negative predictive value (47%-68%, 67%-86%, 38%-50%, and 85%-88%, respectively) when used by nurses and doctors for detecting aspiration.  The sensitivity, specificity, positive predictive value, and negative predictive value when used by speech language therapists for predicting dysphagia were 97%, 90%, 92%, and 96% respectively.

        The combination of a water swallow test with pulse oximetry resulted in the highest sensitivity and specificity (73%-100% and 62%-76%, respectively) of any method of screening for aspiration.  The author concluded that the best evidence-based practice for the detection of dysphagia in acute stroke patients begins with screening using the Standardized Bedside Swallowing Assessment method, followed by an observation of eating as described by Westergren.  The combination of a water swallow test with pulse oximetry may improve the accuracy of screening methods for detecting silent aspiration.

        Ellul, Watkins, Barer (n.d) studied the frequency, clinical course, complications and functional consequences of dysphagia in the acute stages of stroke in 676 consecutively admitted patients with acute stroke. Chest infections were diagnosed in 10% of those with safe and 39% of those with unsafe swallowing, on day one of the hospital stay (without knowledge of the SSA findings).

        It was found that a higher fatality, worse functional outcome and a longer hospital stay was associated with the presence of dysphagia.  This was found in almost all subgroups.  However, the effect was most marked in those without other adverse prognostic factors.  From these findings, the authors concluded that the SSA can be recommended as a standard tool for both observational and intervention studies of dysphagia.  They also recommended SSA to be adapted as a screening tool to be used in routine practice by nonspecialist clinical staff.  They also felt that coordinated interdisciplinary policies could improve the detection and management of dysphagia after stroke.

METHODS

Patient Selection

            The research conducted a 3-month patient gathering procedure, which involves patient acute stoke patients. Ethical considerations had been part of the research implementation via consent approvals of the participants involved. The definition of the condition states that presenting symptoms should appear within 24-h after the stroke onset, which is a primary necessary inclusion criterion for entry.  The SSA test will be taken again at day 7 in order to show possible differentiation. The stated exclusion criteria involve the following:

1. Admission after 24 h
2. Failure to obtain consent
3. Presence of serious intercurrent illness

Testings and Methods

Table 1: DAY1-Reduction Etiology Table: Participant Characteristics Obtained in 3-month Patient Gathering and Assessment
Initial Obtained Participants:	153
Withdrawn Diagnosis	4	2 – Primary Brain Tumor 1 – Metastatic Disease 1 – Transient Ischemic Attack
VF1 examination	149	64 – Undergone exam 85 – Did not Undergo exam
Other Reductions	64	1 – Accidentally erased 2 – Technically poor 1 – Too drowsy to be assessed
Total Patient Involvements	60

¹ VF=videofluoroscopy

Analysis and Implication:

The reduction table illustrates the patient decrease as due to various reasons encountered during the whole time span. Such condition portrayed the methodological, variant, and situational characteristics that led to the trimming down of participants. Analyzing the figure, it significantly implies non-modifiable rationales of participant-reduction etiology; hence, enhancement of participant count is deemed unnecessary. In addition, the reduction rationale mainly satisfies the exclusion criteria, which is appropriately validated.

Clinical and Related Professional Involved

            The research procedure involves independent procedurals of two physician, which are both untrained in dysphagia management. On the other hand, two speech pathologists, both trained in the management of dysphagia are included to conduct tests and validate research outcomes. 

Table 2: DAY1-Age, Gender, and VF Assessment -Participant Characteristics Obtained in 3-month Patient Gathering and Assessments
Undergone VF examination	60	56 – Assessed by SP1 4 – Not Assessed
Age Characteristics:	Median Age: 79 Range Age: (43-90)
Gender Characteristics:	Female: 30 Male: 30
Did not Undergo VF Examination	85	0 – Assessed by SP1 85 – Not Assessed
Age Characteristics:	Median Age: 82 Range Age: (47-93)
Gender Characteristics:	Female: 34 Male: 51

¹ Unavailability for test was due to Logistical reasons; VF=videofluoroscopy

Analysis and Implication:

            The condition of the problem specifically points out the differentiation of age and gender criteria in both VF (videofluoroscopy) non-examinees and examinees. Such research demographic depicts higher age characteristic on VF non-examinees, which evidently implies mostly health-risked individuals that are not anymore suited for VF tests. On the other hand, VF examinees implicated a lesser value, which denotes possible capacity to undergone further testings; although, significant reduction had been made due to logistical reasons.

Intervention Applied

            Upon presentation, consent approval and subject selection, clinical assessment has been conducted to assume possible contraindicative scenario that may present in the whole course of treatment, such as those mentioned in the exclusion criteria. The researchers allotted a timeframe of within 24 hours to assess the patient for possible validation of stroke diagnosis.

            The protocol exemplifies the administration of VF within 3 days of the stroke, unless contraindicated due to unfit conditions or reduction of conscious level. All patients underwent unenhanced computed tomography scan of the brain, unless contraindicated due to health restrictions.

            Medical bedside assessment was categorized into two phases. The following are the procedurals utilized by the physicians X and Y, and SP 1 and 2.

Phase 1: The patient is made to sit upright and given 3 teaspoonfuls of water.  After each spoonful, careful observations are made of swallowing attempts, leakage of water out of the mouth, laryngeal movement, signs of pooling of fluid around the laryngeal opening (“wet” or “gurgly” voice), or signs of aspiration (coughing, choking, respiratory distress).  If the patient attempts to swallow or if there are no problems, a decision is made to proceed to Stage II.

Phase 2: This stage involves drinking 60 ml of water from a glass.  Observations are made similar to stage II, as well as an overall judgment on whether the patient’s swallowing is “safe,” “possibly unsafe” or “definitely unsafe.”  If the swallowing is “safe,” then free diet/fluids are given to the patient and the patient is observed when eating solid food.  Another observation is made with a glass of water before the next meal.  In case the patient deteriorates, the assessment can be repeated.

The SSA methodology utilized by SP (Speech Pathologist) involves categorization of whether it is unsafe or safe for individuals’ mechanism of swallowing. On the other hand, VF results report categories, particularly aspirating if barium enters the airway and passes below true vocal cords, and not aspirating if results otherwise.

RESULTS

            The results of the study have significantly compared outcomes from both bedside assessments and VF procedure. In addition, the primary subjects assessed are with varying total of final participant count obtained from the 3-month gathering procedures. However, PHYSICIAN-X have included the logistically excluded participants for SSA implementation.

Table 3: DAY7-SSA Assessment Outcomes: Participant Characteristics Obtained in 3-month Patient Gathering and Assessments
PHYSICIAN-X 60 Total Assessed	35 (58%)	Safe Swallow
	25 (41%)	Unsafe Swallow
SP1 49 Total Assessed	38 (78%)	Safe Swallow
	11 (22%)	Unsafe Swallow

In terms of compatibility results, moderate agreement between and significantly, higher agreement between SP compared to the physicians. Compatibility ratings exceeded to 75% agreement for the pair of physicians, while SP obtained 93% agreement percentage. Utilizing the results of confidence interval, SP obtained results of 0.55-1.00, which is higher compared to the physicians (CI)=0.26-0.73.

Table 4: 1 DAY7-VF Utilization Outcomes – Assessed by SP1, PHYSICIAN-X and VF
Aspirates on VF (13)	8 out of 13	Not detected at bedside by SP1
	5 out of 13	Not detected at bedside by PHYSICIAN-X
Do not Aspirate on VF (43)	6	Unsafe Swallow
	37	Safe Swallow
Total Patient Involvements	56

            ¹ VF=videofluoroscopy

            Relating the results to table 3, VF somehow illustrates the same implicative results obtained in SSA intervention. In such case, the effectiveness of SSA diagnostic has the potential and possibly comparable to the results of such much more complex procedure, VF. However, another view to determine is the aspiration predictives obtained from the results of VF and SSA in order to further validate the effectiveness of SSA.

Table 5: DAY7-Aspiration Predictives– Assessed by SP1 and PHYSICIAN-X
Criteria Imposed	Predictives (%)	Obtained Results (%)
SP1
Sensitivity	75	90
Specificity	72	86
PPV1	41	50
NPV2	91	85
PHYSICIAN-X
Sensitivity	75	70
Specificity	72	66
PPV1	41	36
NPV2	91	89

¹ Positive Predictive Value

² Negative Predictive Value

            The data illustrated portrays the higher obtained results of SP1 compared to predictives except for NPV. On the other hand, PHYSICIAN-X had obtained data that are significantly lower than the expected outcomes, although the data obtained are lower than the data of SP1, particularly NPV but the opposite in terms of sensitivity. Such data implies incongruencies on both implemented results, which endeavors possible inaccuracy as manifested by the discrepancy particularly on NPV. However, significantly, sensitivity plays the major prime results.

Table 6: SSA Assessment Outcomes on Day 1 and 7
	Day 1	Day 7
PHYSICIAN-X 60 Total Assessed	14 (23%)	35 (58%)	Safe Swallow
	46 (77%)	25 (41%)	Unsafe Swallow
SP1 60 Total Assessed	9 (15%)	47 (78%)	Safe Swallow
	51 (85%)	13 (22%)	Unsafe Swallow

            Data shows that day 1 and day 7 outcomes provided significant results comparable to other table results, which is mainly the increase of Safe swallow category. SSA has provided an assessment of higher results in day 7 as validated by VF results. The results on day 1 is comparably more on unsafe swallowing; however, on day 7, there are significantly increased results.

DISCUSSION

        In this study, the version of the SSA used by the SP, as an initial screening test is a simple step-by-step procedure, and retains only the most important items of the original SSA.  This version of the simplified SSA has been designed in such a manner as to ensure maximum safety for the patients. An initial assessment of whether the patient is alert enough for the study and an evaluation of other general factors, which are likely to affect swallowing safety, are made first.  Further study is carried out only after ensuring that all these assessment criteria is met.  A decision on proceeding to stage II of SSA exam is made only if the patient makes some attempts to swallow or if there are no problems.  If the speech pathologist staff felt that swallowing is safe at the first assessment, normal oral feeding was allowed.  These patients have been re-assessed carefully before the next meal, and a watch was kept for any sign of difficulty or distress while eating or drinking.  All these measures ensured the safety of the procedure.

        In addition to noting for signs of aspiration (coughing, choking, respiratory distress), observations and an overall judgment is made on whether the patient’s swallowing is “safe,” “possibly unsafe” or “definitely unsafe.”

        In the analysis of the study directed in table 3, the SSA trained SP have evidently provided more accurate results compared to the doctors. The results obtained were not influenced by external or internal factors as validated by the same inference of both pairs. As for these outcomes, implications suggest the need for health care staffs, such as speech pathologists

and physicians, to undergo significant training for the grant of implementation for the procedure.

            In terms of SSA effectiveness as diagnostic procedure in swallowing difficulties, overall data suggests 70% sensitivity reports from medical bedside assessment, while 90% for trained speech pathologists. However, with the ratings of 90% with the trained SP compared to 70% of the untrained physicians, the sensitivity results justify the effectiveness of such procedure. According to bedside results, the majority of the patients with acute stroke progress to safe swallowing at day 7.  The data on day 1 has shown majority results of unsafe swallowing, which connotes increased risk of aspiration; however, on day 7, test revealed that safe swallowing is already present. The test results by SSA are validated further by complex radiologic exam, VF, and has proven the almost similar results.

            Radiological examinations are complex and most of the time inapplicable especially in variant urgencies, and with a simple test, such as SSA, further diagnostics and prevention can be acquired. Moreover, aspiration predictives are of different nature than dysphagia; although, these conditions are most of the time related especially in swallowing complications. The importance and significance provided by SSA is the diagnosis of unsafe and safe swallowing, which entails appropriate diagnostic especially for individuals with unsafe swallowing capacity. It is essential, however, to note further validations for safe swallow individuals before having intake. Meanwhile, unable to swallow is validated to confirm negation of swallowing inductors.

CONCLUSION

            In conclusion of the study, it has been found that the SSA procedure is a very crucial yet validating diagnostic approach. There are numerous drawbacks of current swallowing assessment methods like gag reflex, FEES, videofluoroscopy, water swallow test, pulse oximetry etc.  Currently, SSA is the only screening tool, with good reliability data and good results in terms of determining unsafe swallowing criterion. Furthermore, validation is essential for those individuals categorized in safe swallowing groups; since, evidently on this research, safe swallow outnumbered the unsafe swallow groups, but later on aspirating predictives, different results came up.

            SSA is proven to be beneficial like that of the complex procedures of detecting swallowing safety, and it provides significant results in obtainment of patients with risk of swallowing. The procedure is reliable for this type of scenario, which significantly diminish the stress load of problem diagnostics. Speech pathologists and other administratives of such procedure should be taught well in order to implement such test accurately and appropriately. Aspiration after stroke may occur before, during or after the swallow. It is therefore very important to identify at an early stage those patients who are at an increased risk of aspirating, since it is associated with a high fatality rate.

The SSA was found to be a simple, safe, and effective procedure in the detection of dysphagia in the first few days after stroke as validated by swallowing safety results.  This study supports the use of the SSA by speech pathologists at the Neurology and ENT Departments of King Khalid National Guard Hospital, as a screening tool for dysphagia in all patients admitted with acute stroke.

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