Royal Brisbane Hospital Outcome Measure Research Articles

Acupuncture for Poststroke Dysphagia: A Pilot, Nonrandomized, Self-Controlled Trial.

Objective To evaluate the effectiveness and safety of acupuncture treatment for dysphagia as a complication of stroke. Methods and Design. This is a multicenter, pragmatic, nonrandomized, self-controlled clinical trial. A total of 39 patients were recruited from several Chinese medicine outpatient clinics and hospital-affiliated speech therapy outpatient clinics in Hong Kong. 26 patients completed all the 24 sessions of acupuncture treatment within two months, and only 12 of them were used as self-control. For the self-control group, the retrospective clinical data was taken from the electronic patient records with patient consent. The descriptive swallowing function data were converted into the quantitative Royal Brisbane Hospital Outcome Measure for Swallowing (RBHOMS) scores by two registered speech therapists through a validation process. And the data were validated by reaching consensus between the two speech therapists. All subjects underwent a baseline assessment before commencement of treatment, and outcome assessments were conducted upon the completion of treatment. The primary outcome measure is the RBHOMS score, which is a swallowing disability rating scale for monitoring difficulties in daily swallowing function. Secondary outcome measures include the Chinese version of the Swallow Quality-of-Life Questionnaire and adverse events. All the primary and secondary outcomes were assessed at baseline as well as at the end of acupuncture treatment (month 2). Results A total of 39 participants aged 46 to 89 years were enrolled in the study, and the male-to-female ratio was 15 : 11. The mean baseline RBHOMS score of all 39 participants was 5.92 ± 2.23. The mean retrospective RBHOMS score of the 12 subjects who were used as self-control was 5.67 ± 1.72 before enrollment, while the mean RBHOMS score of the 26 participants who completed all the 24 sessions of treatment was 6.92 ± 2.07. There were statistically significant differences between the RBHOMS score at the completion of treatment and baseline (p=0.006), and retrospective data (p=0.042). Moreover, a significant difference was also found in terms of swallow quality-of-life score before and after acupuncture treatment (p < 0.01). Conclusions This pilot study provides preliminary evidence for the effectiveness of acupuncture for poststroke dysphagia. The findings from this trial can be used as a foundation for future full-scale randomized controlled clinical trials to assess the efficacy and safety of acupuncture for poststroke dysphagia. Ethics and Dissemination. The ethical approval of the clinical research study was granted by the Research Ethics Committee of both New Territories East and West Cluster of Hong Kong. Written informed consent was obtained from all participants, and the study was undertaken according to the ICH-GCP Guidelines. Trial Registration. This trial is registered with ChiCTR-TRC-12002621 and the registration date is 2012-10-26.

Effectiveness and Safety of Acupuncture for Poststroke Dysphagia: Study Protocol for a Pragmatic Multicenter Nonrandomized Controlled Trial.

Background. Dysphagia is one of the most common complications of stroke. Acupuncture is widely employed to treat poststroke dysphagia in East Asia. No evidence is established to support such treatment approach. This proposed study aims to evaluate the effectiveness and safety of acupuncture for the treatment of poststroke dysphagia. Methods and Design. This is a multicenter, pragmatic, single-blinded, nonrandomized controlled clinical trial. A total of 140 eligible patients will be enrolled in the study. Subjects who are eligible in study but refuse to have acupuncture treatment will be put on the no-acupuncture control arm. Both groups of patients will receive standard routine care, while the patients of intervention group will receive add-on standardized acupuncture treatment. Each participant in intervention group will receive a total of 24 sessions of acupuncture treatment (three times per week). The primary outcome measure is the Royal Brisbane Hospital Outcome Measure for Swallowing (RBHOMS). Secondary outcome measures include functional oral intake scale, swallow quality-of-life questionnaire in Chinese version, BMI of the participant, and adverse events. All outcome measures will be assessed at baseline, at the end of acupuncture treatment (month 2), and at two months after treatment (month 4). Ethics and Dissemination. The ethics approval of clinical research study was granted by the Research Ethics Committee of both New Territories East and West Cluster of Hong Kong. Written informed consent will be obtained from all participants and the study will be undertaken according to the ICH-GCP Guidelines. Trial Registration. This trial is registered with chictr.org (registration number: ChiCTR-TRC-12002621 and registration date: 2012-10-26).

Prospective swallowing outcomes after IMRT for oropharyngeal cancer: Dosimetric correlations in a population-based cohort

ObjectivesTo identify dose constraints to preserve swallowing after head and neck (H&N) radiotherapy using prospectively collected functional outcomes. Materials and methodsStage III–IV oropharyngeal cancer patients were prospectively evaluated using the Royal Brisbane Hospital Outcome Measure for Swallowing and Performance Status Scale for H&N Cancer Patients at pre-treatment and 3, 6, 12, and 24months after intensity-modulated radiotherapy. Dosimetric parameters were correlated with swallowing function. ResultsNinety-six patients were evaluated with median follow-up of 14.1months (interquartile range 9.9–26.3). Six patients (8.3%) remained feeding tube (FT) dependent at 12months. At 2years, 32.6% tolerated a normal diet without restrictions. Mean doses of 55Gy to supraglottic larynx, 44Gy to glottic larynx, 48Gy to cricopharyngeus, and 44Gy to esophageal inlet were associated with >25% risk of FT dependence at 6months. ConclusionHigher mean doses to the larynx and pharyngo-esophageal junction were associated with longer duration of FT dependence and dietary restrictions.

Impact of feeding tubes on prospective functional outcomes in patients with locally advanced head and neck cancer undergoing radiation therapy

PurposeThe optimal timing of enteral feeding tube (FT) insertion during radiation therapy for head and neck cancer remains controversial. This study compares prospectively collected functional outcomes for prophylactic versus reactive insertion. Methods and materialsPatients undergoing primary radiation therapy for stage III-IV head and neck cancer between 2004 and 2009 underwent functional outcome assessment at baseline and 3, 6, 12, 24, and 36 months posttreatment. Instruments included the Royal Brisbane Hospital Outcome Measure for Swallowing, Performance Status Scale for Head and Neck Cancer Patients, and modified Edmonton Symptom Assessment Scale. Multivariable regression analysis was conducted to determine the impact of FT use on functional outcomes. ResultsA total of 178 patients were assessed with a median follow-up of 36.4 months. Use of an FT was prophylactic in 92 and reactive in 24; no tube was used in 62 patients. Compared with prophylactic placement, reactive FT use was not associated with worse function for Performance Status Scale for Head and Neck Cancer Patients Normalcy of Diet for soft foods (adjusted odds ratio [AOR] 1.16, P = .85) or Eating in Public (AOR 1.87, P = .31). Similarly, there were no differences in the Royal Brisbane Hospital Outcome Measure for Swallowing for modified diet (AOR 1.27, P = .7) or FT dependence (AOR 3.01, P = .2). ConclusionsThere were no significant differences in long-term swallowing function between patients who received a prophylactic versus reactive FT.

Does Low Dose Angiotensin Converting Enzyme Inhibitor Prevent Pneumonia in Older People With Neurologic Dysphagia–A Randomized Placebo-Controlled Trial

ObjectiveTo examine if angiotensin converting enzyme inhibitor reduces the risk of pneumonia in older patients on tube-feeding because of dysphagia from cerebrovascular diseases. DesignRandomized placebo-controlled trial. SettingAcute and subacute geriatrics units, speech therapists' clinic, and nursing home. ParticipantsOlder patients on tube-feeding for >2 weeks because of dysphagia secondary to cerebrovascular diseases. InterventionParticipants were randomized to lisinopril 2.5 mg or placebo once daily for 26 weeks. MeasurementsParticipants were followed up at weeks 12 and 26. The primary outcome was the incidence rate of pneumonia as determined by pneumonic changes on x-ray and clinical criteria. The secondary outcomes were mortality rate and swallowing ability as defined by the Royal Brisbane Hospital Outcome Measure for Swallowing at week 12. ResultsA total of 93 older patients were randomized. In interim analysis, 71 completed the trial, whereas 15 had dropped out. Among those who had completed the trial, odds ratio (OR) for death was significantly higher in the intervention group (unadjusted OR 2.94, P = .030; fully adjusted OR 7.79, P = .018). There was no difference in the incidence of pneumonia or fatal pneumonia in the 2 groups. The intervention group had a marginally better swallowing function at week 12 (Royal Brisbane Hospital Outcome Measure for Swallowing score: 4.2 ± 1.5 in intervention group, 3.5 ± 1.5 in placebo group, P = .053). As a result of the interim finding on mortality, the trial was prematurely terminated with 7 participants still in the trial. ConclusionsLow dose lisinopril given to older tube-fed patients with neurologic dysphagia resulted in increased mortality, although swallowing function showed marginal improvement. ACE inhibitors did not prevent pneumonia in older patients with neurologic dysphagia and might increase mortality.

Prospective functional outcomes in sequential population based cohorts of stage III/ IV oropharyngeal carcinoma patients treated with 3D conformal vs. intensity modulated radiotherapy.

Background and purposeTo compare early (3 and 6 month) and later (12 and 24 month) functional outcomes of stage III and IV (M0) oropharyngeal squamous cancer patients treated in sequential cohorts with 3D conformal (3DCRT) or intensity modulated radiotherapy (IMRT).Patients and methods200 patients in sequential population based cohorts of 83 and 117 patients treated at a single institution with 3DCRT and then IMRT respectively were prospectively assessed at pre-treatment and 3, 6, 12 and 24 months post treatment. A standard functional outcomes protocol including performance status (KPS, ECOG), 3 Performance Status scales for Head and Neck (PSS-HN), the Royal Brisbane Hospital Outcome Measure for Swallowing (RBHOMS), Voice Handicap Index-10 (VHI-10) and self-rated xerostomia were applied.ResultsMean age at diagnosis was 59 years. The primary site was base of tongue in 77 and tonsil or soft palate in 123 patients. Median follow up was 2.5 years for the second cohort. Concomitant therapy was used in 159 (79.5%). Overall survival at 3 years was 75.6% and 71.5% for IMRT and 3DCRT cohorts respectively (not significant). A multiple imputation technique was used to estimate missing values in order to avoid a healthy patient bias. KPS and ECOG reached nadirs at 3 to 6 months but approached baseline values at 12 to 24 months and did not differ by treatment. The 3 PSS-HN scales, Eating in Public (p < 0.001), Understandability of Speech (p = 0.009) and Oral Diet Texture (p = 0.002) and all showed significantly better outcomes in favor of IMRT. The RBHOMS showed a difference in favor of IMRT which appeared during 3 to 6 months (p < 0.001). The VHI-10 also showed a difference in favor of IMRT (p = 0.015). Self-rated xerostomia did not differ at 3 and 6 months but was significantly better in favor of IMRT after 12 months p = 0.005ConclusionsA prospectively administered functional outcomes protocol showed meaningful differences in favor of IMRT over 3DCRT early (3–6 months) and later (12–24 months) in the treatment of oropharyngeal carcinoma with equivalent survival. These data support the adoption of IMRT as the standard radiation treatment method for patients with stage III and IV (M0) oropharyngeal squamous carcinoma. KPS and ECOG may not be sensitive to oropharyngeal cancer patients’ functional outcomes by treatment.

Dysphagia and swallowing-related quality of life in Friedreich ataxia

Dysphagia in Friedreich ataxia (FRDA) and its impact on quality of life is not adequately understood. The objective of this study was to characterise dysphagia in FRDA and to determine the impact of swallowing dysfunction on activities, participation, and sense of well-being. Thirty-six individuals with a confirmed diagnosis of FRDA were assessed via a clinical bedside examination (CBE), the Royal Brisbane Hospital outcome measure for swallowing, an oral-motor examination and the Australian therapy outcome measures for speech and swallowing (AusTOMS). Data on swallowing function, diet modification and swallowing strategies were collated. Thirty-three (91.67%) participants exhibited clinical signs of dysphagia according to the CBE, and all participants received ratings indicating swallowing difficulties on at least one other measure. Dysphagia in FRDA is characterised by oral and pharyngeal stage impairment relating to incoordination, weakness and spasticity. A significant positive correlation was found between the severity of impairment, activity, participation and distress/well-being on the AusTOMS, suggesting that swallowing function decreases with overall reductions in quality of life. A significant correlation was found between activity on the AusTOMS and disease duration (r=-0.283, p=0.012). No significant correlations were found between dysphagia severity and GAA repeat length, age of onset or disease severity. Participants employing diet modification and swallowing strategies demonstrated higher dysphagia severity, activity limitations and participation restrictions. These data advocate a holistic approach to dysphagia management in FRDA. Early detection of swallowing impairment and consideration of the potential impact dysphagia has on quality of life should be key aspects in disease management.

Late Radiation-Associated Dysphagia (RAD) and Lower Cranial Neuropathy After Oropharyngeal Radiation Therapy: A Case–Control Dosimetric Comparison

Purpose/Objective(s): Many patients will require parenteral nutrition due to dysphagia during definitive radiation therapy for locally advanced head and neck cancer. However, the optimal timing of feeding tube (FT) insertion (prophylactic versus reactive) remains controversial. This study describes prospectively collected functional outcomes comparing prophylactic versus reactive FTs. Materials/Methods: Patients undergoing definitive radiation therapy for stage III and IV head and neck cancer between 2004 and 2009 prospectively underwent functional outcome assessment at baseline and 3, 6, 12, 24, and 36 months post-treatment. The use of FT and timing of insertion was at the discretion of the attending oncologist. Instruments included the Royal Brisbane Hospital Outcome Measure for Swallowing (RBHOMS), the Performance Status Scale for Head and Neck Cancer Patients (PSSHN), and the Edmonton Symptom Assessment Scale. Multivariable analysis was conducted to determine the significance of FT status while controlling for potential confounding variables including age, gender, tumor stage, chemotherapy use, and primary site of disease. Results: A total of 178 patients were assessed with a median follow-up of 36.4 months. FTs were inserted prophylactically in 92 (51.7%), reactively in 23 (12.9%), and no tube in 63 (35.4%) patients. Compared to patients who received a prophylactic FT, those who had a reactive FT did not have a statistically significant difference in worse swallowing functional outcomes for PSS-HN subscales of eating in public (adjusted odds ratio [AOR] 1.65, p Z 0.42), understandability of speech (AOR 0.73, p Z 0.58), and normalcy of diet (AOR 1.39, pZ 0.66). Similarly, there were no differences in the RBHOMS levels for modified diet (AOR 1.00, pZ 0.99) and FT dependence (AOR 1.78, p Z 0.37). Patients who completed treatment without a FT had statistically significantly improved functional outcomes in PSS-HN and RBHOMS scores compared to both FT groups. Conclusions: Patients who received a reactive FT did not have a statistically significant difference in long-term functional outcomes compared to those with a prophylactically inserted FT. These findings warrant confirmation in a larger cohort of patients and should be considered when comparing the risks and benefits of different strategies for FT placement. Author Disclosure: H.C. Quon: None. C. Myers: None. A. Martens: None. J. Butler: None. R. Stimpson: None. D. Duerksen: None. H. CampbellEnns: None.

Feasibility of an Interdisciplinary Early Intervention for Patients with Low Levels of Responsiveness Following an Acquired Brain Injury

There is a scarcity of research investigating interdisciplinary early rehabilitation intervention models for people with low levels of responsiveness following acquired brain injury. This is particularly problematic for service models in acute hospital settings where early rehabilitation of such patients may be assigned a low priority in comparison to other competing demands. This pilot study investigated the feasibility of implementing an interdisciplinary early rehabilitation intervention in an acute neurosciences ward within existing staffing, and describes clinical changes among intervention participants. A prospective longitudinal study, with a matched historical control (individually matched by Glasgow Coma Scale) was undertaken. Prospective intervention participants (n= 13) received up to twice-weekly interdisciplinary intervention in addition to usual care. Matched historical controls (n= 13) received only usual care. Implementing an interdisciplinary early intervention proved feasible in this acute care setting. Significant improvement (alpha = .05) among the patients receiving the interdisciplinary intervention was observed across all clinical outcomes, including: Coma Recovery Scale-Revised, Glasgow Coma Scale, Mental Status Questionnaire, Royal Brisbane Hospital Outcome Measure for Swallowing, selected subtests of the Functional Independence Measure, Acquired Brain Injury Physiotherapy Assessment and the Clinical Outcomes Variable Scale. A future randomised clinical trial is warranted.

Therapeutic effects of acupuncture for neurogenic dysphagia—a randomized controlled trial

ObjectiveTo evaluate the therapeutic effects and long-term efficacy of acupuncture for neurogenic dysphagia. MethodsSubjects with neurogenic dysphagia undergoing routine swallowing management were randomized to receive either 20 sessions of true acupuncture (experimental group) or sham acupuncture (control group 1) for approximately one and a half months. A third group (control group 2) comprised of non-randomized subjects with neurogenic dysphagia who received routine care were recruited from separate wards. The outcomes were assessed by the Royal Brisbane Hospital Outcome Measure for Swallowing (RBHOMS), as well as by the consistencies of ingested food and fluid. ResultsA total of 87 subjects (experimental group, n= 20; control group 1, n=19; control group 2, n=48) were recruited into the trial. The average RBHOMS score showed a greater improvement in the experimental group and in control group 1 than in control group 2. The average levels of food and fluid consistencies displayed greater improvement in the experimental group than in the two control groups. ConclusionsThis study demonstrates that acupuncture may have therapeutic effects and long-term efficacy for neurogenic dysphagia. However, due to an insufficient sample size and the lack of follow-up for control group 2, multi-centre trials employing a larger sample size may be required to draw concrete conclusions.

Validity, reliability and responsivity of the Royal Brisbane Hospital Outcome Measure for Swallowing

One of the main limitations of outcome measures currently in use in many clinical settings is the lack of data to support the reliability and validity of the scales. The present study presents the results of psychometric investigations of the Royal Brisbane Hospital Outcome Measure for Swallowing (RBHOMS), a lO-point scale designed to document changes in swallowing disability. Functional swallowing ability at both hospital admission and discharge was assessed in a group of 285 dysphagic inpatients. Following the clinical bedside examination, all patients were rated using the RBHOMS, the Therapy Outcome Measures (TOM) Dysphagia Disability Scale and the Westmead Outcome Rating Scale. Data from the three measures were compared and contrasted to examine the reliability, validity and responsivity of the RBHOMS. Psychometric analysis of the RBHOMS revealed that the scale is clinically valid and responsive to clinical changes in levels of swallowing disability. In addition inter-rater reliability of the scale was found to be high (r = 0.99). Overall, the psychometric properties of the RBHOMS support that it is a valid clinical tool for documenting functional changes in swallowing disability over time and across different aetiologies.