Mcneill Dysphagia Therapy Program Protocol Download Free Software


Abstract We carried out a systematic review of randomized controlled trials (RCT) of oropharyngeal swallowing interventions conducted between years 2010 and 2013. A systematic literature search of RCTs was conducted using databases MEDLINE (PubMed), PsychInfo, Google Scholar, EBSCO, PROQUEST, Web of Science, and grey literature. Data were abstracted from all eligible studies by the first author and independently assessed by two raters using the Van Tulder scale. A total of 15 RCTs of behavioral swallowing therapy were included for evaluation.

Significant heterogeneity between experimental studies was noted. Only 33% (5) of studies included met the quality criterion identified by the van Tulder scale for high study rigor. Data supporting swallowing rehabilitation methods with adult dysphagic patients is advancing. Although studies intervention approaches remain diverse, the use of RCT designs is increasing with noted improvements in control methods. More research is needed to ascertain the most optimal intervention methodology for dysphagia rehabilitation. Health care decisions are frequently directed by the best available evidence from research studies. As both diagnostic and treatment options multiply rapidly in health care, increases in available research bring with it challenges in identifying which studies are of the highest quality.

The graph below summarizes the impact of the proposed protocol in one of our test locations. McNeill Dysphagia Therapy Program: a case-control. McNeill was actually Hannibal McNeill who was the first patient to volunteer for a research program involving a novel to dysphagia therapy in 2004. Hannibal (like many of our patients) presented with long standing dysphagia following treatment for base of tongue cancer and also surviving a brainstem stroke.

This challenge is made more difficult when different studies provide results that support different conclusions or lead a field erroneously through bias in reporting. To answer these challenges, researchers have developed methods to synthesize and evaluate research from multiple studies.

Systematic reviews represent one method to rigorously compile scientific evidence to answer questions regarding the state of science in an area. They can help clinicians make decisions when similar studies present apparently confusing or conflicting results. Different research designs shed different amounts of light on how treatments work under controlled conditions. Some designs provide information on the association between treatments and their outcomes, but do not control for the myriad of intervening or confounding issues surrounding treatment applications, e.g., age, gender, disease severity, co-interventions, enthusiasm, etc. One design that provides definitive evidence of intervention efficacy is the randomized controlled trial (RCT). The RCT is one of the simplest, but most powerful research designs available to a researcher to evaluate the efficacy of an intervention. The key feature of this design is that, after an assessment of eligibility, subjects in the study are randomly and independently assigned to receive one or other treatments under investigation.

Once randomized the groups are followed in exactly the same way and only differences in response to the treatment they receive are compared. The power of the design lies in its ability to minimize bias in treatment allocation and balance prognostic factors between the groups.

Well-conducted RCTs minimize bias by controlling known and unknown factors (confounders) that may distort treatment effects. Unfortunately, it is estimated that fewer than 10% of all literature published are well-conducted RCTs, with. Like other areas of health care, dysphagia intervention methods are diverse and rapidly advancing within the literature. Common categories of dysphagia rehabilitation methods include; behavioral maneuvers, behavioral compensations, exercise interventions, dietary interventions (including modified diets and enteral feeding methods), pharmaceutical applications, electro-physical applications, and sensory-motor applications to mention but a few. To date, evaluations of the strength of data supporting swallowing interventions have been equivocal. Some reviews identifying an increase in the quality of supportive data whilst others have admonished the field for a lack of supportive evidence and suggested the need for more rigorous study designs (Fig. Fig. 1 Flow chart of study selection process Recently, a published review of abstracts presented to an international dysphagia meeting (Dysphagia Research Society) over the last decade (2001–2011) suggested that there has been a surge in the use of more rigorous research designs to evaluate swallowing.

In fact, they reported that the use of RCT methodologies in that group had tripled since 2001, and that at present RCTs constituted 3.3% of all abstracts presented at this meeting. However, data for this review were generated from study abstracts only and the authors did not evaluate the individual study rigor of each trial using a validated qualitative analysis system. To further evaluate the use of rigor in recent RCT studies in the field of dysphagia rehabilitation, we proposed to undertake a systematic review of all RCTs of behavioral intervention for oro-pharyngeal dysphagia during the period from January 2010 to June 2013. Study Identification Studies were identified using searches on MEDLINE (PubMed), PsychInfo, Google Scholar, EBSCO, PROQUEST Web of Science, and grey literature. In addition, meeting abstracts and Cochrane Reviews and reviews of reference lists of related book chapters and journal articles from January 2010 to June 2013 were screened. A comprehensive list of search terms included; “swallowing intervention,” “swallowing treatment trial,” “randomized clinical trial”, “RCT”, “randomized controlled clinical trial”, “and swallowing rehabilitation trial”, “dysphagia rehabilitation”. MESH terms (PubMed) used included, “humans”, “dysphagia”, “swallowing trial”, “treatment”.

For databases allowing advanced search techniques, articles were restricted to RCTs. Potentially eligible articles were first screened for relevance by the first author, using article titles and then abstracts. Articles that appeared to meet eligibility criteria after this initial review were then reviewed independently by the first and second authors, using the measures described below. Inclusion Criteria The current review included RCTs that assessed the impact of behavioral interventions to reduce or ameliorate oro-pharyngeal dysphagia. Due to the differences in intervention format and treatment goals for programs involving children and adolescents, the current review was restricted to studies investigating adults (age ≥18) only. To be eligible for inclusion, the following inclusion/exclusion criteria were used: (1) must include a randomized control trial design; (2) published in English or capable of being translated; (3) accessible in full text; (4) evaluated an oro-pharyngeal swallowing intervention; (5) assessed a measurable swallowing outcome; (6) did not evaluate a surgical interventions; (7) did not evaluate a pharmaceutical intervention; and (8) was not a device trial.

RCT For the purposes of this systematic review, an RCT was defined a priori as a study in which subjects are randomly allocated (by chance alone) to receive one of several clinical swallowing interventions. One of these interventions must be a standard of comparison or control. This control group should be receiving either no treatment or receive the current standard treatment.

The use of a placebo comparison only without a standard control comparison will be considered a quasi-experimental trial, as the placebo effect alone cannot be adequately identified. Furthermore, for the purposes of qualitative grading, reviewers were advised that an acceptable randomization procedure should include either use of computer generated random numbers or random numbers tables. In addition, concealed allocation should be described as either use of a centralized or independently controlled randomization procedure, serially-numbered identical containers, or randomization sequences not readable until allocation. Data Extraction The first author (G.C.) systematically abstracted data from all articles reviewed in full text including authors, year in which the study was published, country in which the study was conducted, characteristics of the sample (e.g., sample size, gender, age range, diagnostic group, and treatment type), the intervention and control group’s methodology, length of intervention, length of follow-up, and all relevant dysphagia outcome measures. For studies employing more than one treatment arm (or those using factorial designs), only data related to the current review were used. To calculate intervention effect sizes, mean differences between an intervention and a control group and associated standard deviations (if available) or next through the use of either pre- and post-test means and standard deviations, group n, and F ratio were abstracted.

If more than one intervention arm met criteria for inclusion, data were combined to create pooled estimates. Following this, effect data were standardized using accepted methods to single comparable effect metric, Cohen’s d. Quality Assessment Two independent reviewers, blinded to the study’s’ authors, author’s affiliations, and journal, independently used the van Tulder scale to determine the quality of the trials. Where a selected study included an author of this paper, it was re-directed to a third independent reviewer.

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The van Tulder scale is a qualitative assessment tool designed to make assessments on 11 components of RCT study design including randomization method, allocation concealment, baseline characteristics, patient blinding, therapist blinding, observer blinding, co-intervention control, compliance, drop-out rate, end-point assessment time point, and intention-to-treat analysis (see Table 3 in Appendix). The reviewer is required to select ‘yes’, ‘no’, or ‘don’t know’ for each item. A rating of ‘1’ is allocated for any affirmative response, or ‘0’ for ‘no’, or ‘don’t know. When ≥5 items are satisfied (≥5 points), the quality of the report is deemed high. The van Tulder scale has previously been evaluated for interrater reliability, face, content, and concurrent validity. In the present study, only ‘high quality’ rated studies were included in the analysis of primary effect within the systematic review (see Table 4 in Appendix).

Two independent raters utilized a standardized rating sheet to record study details for the van Tulder qualitative grading (Table ). The inter-class correlation coefficient for van Tulder scores between the reviewers was α = 0.976 (95% CI 0.938–0.991).To further explore areas of concordance in ratings across studies a fixed marginal kappa analysis was conducted and revealed 94% agreement in coding across studies. Kappa values of 0.75 or higher reflect excellent agreement between raters. Overall rater agreement was strong across categories of the scale, ranging from 86 to 100% agreement. The item demonstrating the greatest discrepancy between raters was item H; “were co-interventions avoided or controlled”. This item was often not explicitly stated by authors and overall agreement for this item was 86%.

Inconsistencies identified between raters were later discussed and resolved by consensus. Study Randomization detailed Allocation concealed Similar groups at baseline Subject blind Therapist blind Assessor blind Co-intervention controlled Acceptable compliance Acceptable withdrawal rate Timing of outcome ITT Total Bevan et al.

a √ √ √ √ √ √ √ 7 Xia et al. √ √ 2 Karagiannis et al. √ √ √ √ 4 Middleton et al. a √ √ √ √ √ √ √ √ 8 Tang et al.

a √ √ 2 Van der Molen et al. √ √ √ √ 4 Kotz et al. √ √ √ √ 4 Oh et al. √ √ 2 Carnaby-Mann a √ √ √ √ √ √ √ 7 Chen et al. √ √ √ 3 Carlaw et al. √ 1 Carnaby et al.

a √ √ √ √ √ √ √ √ 8 Heijnen et al. √ √ 2 Carnaby ANSRS a √ √ √ √ √ √ √ √ √ 9 Long et al. √ √ √ √ 4 Quasi experimental trials-sham control only Troche et al. √ √ √ √ √ √ √ 7 Terre et al. √ 1 Yang et al.

√ √ √ √ √ √ √ 7 Feng et al. √ √ √ √ √ 5 Chan et al.

√ √ √ √ 4. ADenotes high-grade RCT Results Initial queries using the search terms listed yielded a total of 164 articles of which the titles were screened.

Following this, 128 studies did not meet the inclusion criteria and were excluded (Table ). Thirty-three studies were evaluated by abstract review, of which ten were deemed ineligible for the reasons; failure to use of RCT design ( n = 2) lack of control arm ( n = 2), lack of randomization ( n = 3), review article only ( n = 3).After reviewing the full text studies a further three studies were eliminated due to failure to provide randomization details ( n = 2) and providing a protocol only ( n = 1). In total, 20 studies met all eligibility criteria and were included in the systematic review. While all the studies included self-identified as RCTs, only 15 met the RCT criteria by including a true comparison (control) arm ,. A further 5 studies utilized sham/placebo comparators only (without a standard control comparison) or non-randomized controls and were deemed quasi-randomized trials ,. Quality Ratings The 15 studies identified as RCTs averaged a quality rating score of a 4.46 (SD 2.6), with scores ranging from 1 to a score of 9. The modal score for the group was 4 (range 1–9).


Of the 15 included RCTs, five studies were conducted in Asia with an average quality rating of 2.6 (SD 0.89), four trials were conducted in the USA and scored an average quality rating of 7 (SD 2.1), two in Europe with an average quality rating of 3 (SD 1.4), and two from Australia rating 6 (SD 2.8) and a single trial from the UK scoring 7. Only 5 RCTs met the van Tulder criteria (5) indicating high quality trials ,. Only 46% (7) of studies provided adequate detail regarding the randomization and concealment procedures, while 86% (13) studies identified and confirmed similarity of baseline group comparability (item C) and 93% (14) defined similar timing of evaluation points between the groups (item J).

26% (4) of studies reported post-intervention data with. The 15 RCTs included a diverse range of swallowing intervention methodologies (Table; Table 5 in Appendix) including: dietary , , electrotherapeutic , , preventative behavioral exercise , , behavioral maneuvers and compensations , , program effectiveness , and behavioral exercise alone. Within the quasi-experimental trials, three studies evaluated alternative medicine approaches , , one evaluated a postural adjustment , and another evaluated respiratory strength training. Study Country of origin Sample size Gender (M:F) Sample age (Mean, SD) Diagnostic group Severity of dysphagia (baseline) Treatment type Primary outcome measures Secondary outcome measures Intervention type = dietary Bevan et al. Does looped nasogastric tube feeding improve nutritional delivery for patients with dysphagia after acute stroke?

Systematic reviews are conducted to appraise the volume and strength of a body of research surrounding a topic. As the name implies, they are systematic, organized, comprehensive, and structured investigations. A thorough systematic review can assist researchers and clinicians in outlining the benefits of available treatments, and provide direction for future work. We conducted a systematic review of dysphagia rehabilitation and evaluated the quality of RCTs meeting recommended methodological rigor. Our review identified 15 studies meeting the a priori inclusion criteria for a randomized trial of oro-pharyngeal dysphagia in adults over the years 2010–2013.

Of those studies, only five met the criteria for high quality using a validated evaluation scale. Specific weaknesses of the lower rated studies included: incomplete details regarding randomization procedures, lack of information on allocation concealment, limited blinding of subjects and therapists to the provision of the intervention, control of co-intervention contamination, and management/reporting of sample attrition. Importantly, an additional five studies were designated as quasi-experimental trials as they did not include a standard control comparator in the trial design. If a study provides only comparison between an active arm and a placebo, critical information about the true and placebo effect of an intervention cannot be fully obtained. For example, where the natural progression of a disease is variable or unknown, we would not be able to identify the true responders, as some patients will garner benefit by any intervention alone (enthusiasm bias).

Without a true “control”, the impact of the placebo strategy cannot be determined and may lead to exaggerated treatment effect estimation. Another potential problem identified from the current review is the continuing publication of trials with limited sample sizes. Small clinical trials ( n.