Time to Retest in French Time to Test Again in French
Forepart Neurol. 2019; 10: 1180.
Multilingual Validation of the Start French Version of Munich Dysphagia Test—Parkinson'south Disease (MDT-PD) in the Luxembourg Parkinson's Study
Janine A. Simons
iDepartment of Neurology, Academy of Lübeck, Lübeck, Germany
twoClinical and Experimental Neuroscience, Luxembourg Centre for Systems Biomedicine, University of Luxembourg, Esch-sur-Alzette, Luxembourg
Michel Vaillant
iiiCompetence Heart for Methodology and Statistics, Luxembourg Constitute of Wellness, Luxembourg, Luxembourg
Geraldine Hipp
2Clinical and Experimental Neuroscience, Luxembourg Centre for Systems Biomedicine, University of Luxembourg, Esch-sur-Alzette, Luxembourg
fourParkinson's Research Clinic, Centre Hospitalier de Luxembourg, Luxembourg, Grand duchy of luxembourg
Lukas Pavelka
iiClinical and Experimental Neuroscience, Luxembourg Centre for Systems Biomedicine, Academy of Luxembourg, Esch-sur-Alzette, Luxembourg
ivParkinson's Research Dispensary, Heart Hospitalier de Luxembourg, Grand duchy of luxembourg, Luxembourg
Lara Stute
iiClinical and Experimental Neuroscience, Grand duchy of luxembourg Centre for Systems Biomedicine, University of Luxembourg, Esch-sur-Alzette, Luxembourg
4Parkinson'southward Research Clinic, Centre Hospitalier de Luxembourg, Grand duchy of luxembourg, Luxembourg
Claire Pauly
twoClinical and Experimental Neuroscience, Luxembourg Centre for Systems Biomedicine, University of Grand duchy of luxembourg, Esch-sur-Alzette, Luxembourg
4Parkinson'due south Research Clinic, Heart Hospitalier de Luxembourg, Luxembourg, Luxembourg
Rejko Krüger
twoClinical and Experimental Neuroscience, Luxembourg Eye for Systems Biomedicine, Academy of Luxembourg, Esch-sur-Alzette, Luxembourg
4Parkinson's Enquiry Dispensary, Centre Hospitalier de Grand duchy of luxembourg, Luxembourg, Luxembourg
5Transversal Translational Medicine, Luxembourg Establish of Health (LIH), Strassen, Luxembourg
Received 2019 May 7; Accepted 2019 Oct 22.
Abstruse
Introduction: The Munich Dysphagia Test for Parkinson's disease (MDT-PD) was initially developed and validated in the German language population equally a highly sensitive and specific self-reported screening questionnaire to detect early on oropharyngeal symptoms and aspiration hazard in patients with idiopathic Parkinson'due south disease (iPD). In order to make this tool attainable for prevention in the French speaking populations worldwide, nosotros performed the first French translation and provide a linguistic and psychometric validation in the unique multilingual surroundings of the Luxembourg Parkinson'due south Study.
Methods: We performed the translation of the MDT-PD into French according to WHO guidelines and after performed the linguistic validation including native speakers. For psychometric validation, 46 patients with parkinsonism from Luxembourg and the Greater Region without severe cognitive impairment were recruited in the frame of the Luxembourg Parkinson's Report. All patients were fluent in French and High german completed the MDT-PD in both languages (three times in total).
Results: Linguistic and psychometric validation of the French MDT-PD was reflected by a high test-retest (10/26 questions with K > 0.6 and 10/26 with 0.4 < K ≤ 0.six) and language reliability (12/26 K > 0.half dozen and 8/26 0.4 < K ≤ 0.vi), with an internal consistency for the French (Cronbach's blastoff 0.84) and German language version (0.87); potent item collinerarity strengthens the internal consistency. No significant differences between MDT-PD score distribution and clinical parameters assessing, for example, disease progression, motor state, or knowledge has been observed.
Decision: Based on a multilingual arroyo in the Luxembourg Parkinson Study, we validated the translation of the first French MDT-PD as a not-invasive tool for early on detection of dysphagia in patients with parkinsonism. The unexpectedly loftier number of positively screened patients at before disease stages indicate options for new prevention strategies in large French speaking populations worldwide. Diagnostic validation using clinical and endoscopic swallowing evaluation will exist continued before long.
Keywords: parkinsonism, swallowing problems, dysphagia, patient questionnaire, early detection, linguistic and psychometric validation
Highlights
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- First French version of MDT-PD questionnaire provides a not-invasive and easy to administer screening tool for the French speaking population.
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- Study was conducted among the patients included in the Grand duchy of luxembourg Parkinson's Study with long term almanac follow-up and deep clinical, genetic, and multi-omics phenotypisation that volition allow for further assay and prospective follow-up of the analyzed patients.
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- Linguistic and psychometric validation resulted in both high reliability properties and high linguistic communication validity.
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- Highlighting the value of MDT-PD implementation as it allows an early detection of oropharyngeal symptoms likewise every bit aspiration adventure and therefore supports early dysphagia treatment, preventing severe clinical complications, and maintaining patients' quality of life.
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- The observation of a H&Y stage independent presence of swallowing problems strengthening the hypothesis of dysphagia as an early centric symptom in PD.
Introduction
Oropharyngeal dysphagia is a frequent symptom in both idiopathic Parkinson's disease (PD) and atypical forms of parkinsonism (aPS). Due to an early loss of oropharyngeal sensibility and an impaired self-awareness a pooled prevalence for PD is reported to be 35% (95% CI 28–41) when uncomplicated self-cess was performed, whereas 82% (95% CI 77–87) when objective instrumental measures were taken into account (i).
Reverse to the more often than not excepted conventionalities that dysphagia occurs in the advanced stages of PD just, a disarming body of show suggests it to be an early on symptom with non-negligible consequences (2) such equally malnutrition, weight loss, dehydration, or aspiration pneumonia with severe impact on prognosis and quality of life. In order to prevent the clinical complications, a timely diagnostic approach and professional person care is essential, thus an accessible non-invasive early screening for dysphagia is required (3, 4).
Besides the currently practical golden standard examination with flexible endoscopic evaluation of swallowing (FEES) or videofluoroscopic swallowing report (VFSS) to diagnose dysphagia, there are up to date only two validated dysphagia questionnaires available particularly adapted for PD, the Munich Dysphagia Examination-Parkinson's Disease [MDT-PD (four)] and the Swallowing Disturbance questionnaire [SDQ, (5)]. While the SDQ only allows to screen for astringent swallowing impairment with aspiration, the MDT-PD was developed among 187 individuals in society to screen for the presence of beginning oropharyngeal symptoms, and to assess the gamble for laryngeal aspiration in PD patients (6, 7). The MDT-PD is considered to be a highly sensitive and specific weighted self-reporting outcome questionnaire (8). With respect to the screening results, recommendations and indications for further instrumental diagnostics and advisable medical therapies tin exist provided (cf. Supplement i, Tabular array 1.ane or directly on the MDT-homepage/web application world wide web.mdt-parkinson.com).
The questionnaire contains 26 items, which all have been previously tested for reliability and validity. A short-form description is given in Supplement 1, Table i.2. It has been cross-nationally translated into other languages including English, all the same yet there was no French version of the questionnaire available, although 274 one thousand thousand people worldwide from 29 countries use French in their daily life.
The objective of this work was to deliver a first translated version of MDT-PD in French and to make up one's mind its validity in the multilingual Luxembourgish population where participants were recruited in the frame of the Luxembourg Parkinson's Study (9). The goal of the report was (i) a linguistic and (ii) a psychometric validation of the French version of MDT-PD questionnaire assessing test-retest and language reliability backdrop, and construct validity with the focus on patients diagnosed with PD as well every bit aPS.
Materials and Methods
Study Population and Design
The subjects enrolled in this study accept been recruited in the telescopic of the Grand duchy of luxembourg Parkinson's study, a nation-broad, monocentric, descriptive, observational, longitudinal-prospective cohort study with an annual follow-upward of patients (ix).
All the subjects have signed a written informed consent, and the collection has been approved by the National Ethics Lath (CNER Ref: 201407/13) and Data Protection Committee (CNPD Ref: 446/2017).
Additionally, a clinical steering commission composed of different health professionals from Luxembourg involved in PD care has been appointed and supervises the recruitment procedures.
To be included in the study, all subjects must run across either the U.k. Parkinson's Disease Social club Brain Bank Clinical Diagnostic Criteria (10, xi) for PD or the criteria defined for the respective atypical forms of parkinsonism, including progressive supranuclear palsy (PSP) (12, thirteen), multiple system atrophy (MSA) (12), corticobasal syndrome (CBS) (13), or a secondary form of parkinsonism, vascular parkinsonism (VP) (fourteen), based on internationally established criteria. Furthermore, participants must speak fluently French for the ones implicated in the linguistic validation stage and additionally German, for the grouping implicated in the psychometric validation phase.
Equally the MDT is a self-reporting questionnaire, participants with a significant cerebral impairment as divers past a MoCA score < 17 were excluded.
All subjects enrolled in the Luxembourg Parkinson's Study undergo a comprehensive clinical phenotyping including the assessment of motor and non-motor aspects of PD, including (merely not limited to) Hoehn & Yahr staging, MDS-UPDRS I–IV, cerebral assessment via MoCA and disease elapsing since diagnosis. For more details on the report blueprint and protocol cf. Hipp et al. (ix).
The MDT-PD French study has been divided into ii phases, (i) the translation and (ii) the validation including (a) linguistic validation of the translation, and (b) the validation of its psychometric aspects, namely examination-retest reliability, linguistic communication reliability, internal consistency, and construct validity. In a continuing 3rd phase the diagnostic validation will exist performed separately using the aureate standard of clinical and endoscopic swallowing evaluation (cf. Effigy 1).
Flowchart of study phases. MDT-PD, Munich Dysphagia Test–Parkinson'due south Disease; CSA, Clinical Swallowing Assessment; FEES, Flexible Endoscopic Evaluation of Swallowing; PPV, Positive Predictive Value.
Questionnaire Description
The questionnaire contains 26 items (Q1–261). Items Q1–Q23 are rated on a 0, one, 2, and 3 scale, while Q24–26 are rated dichotomously (0, 3). A detailed questionnaire overview is given in Supplement 1.
Phase I: Translation
In a offset step, the High german MDT-PD was translated into French with a forward-backward method, past four translators complying with the WHO guidelines for cross-national translations of clinical questionnaires (15).
Study Grouping
The translation group included the copyright holder of the original German language test version (speech communication-language pathologist) and four at least bilingual (fluently German language and French speaking at C2 level) experts, one of them with French every bit mother tongue, including an epidemiologist, a neurologist and two neuropsychologists. Additionally, a group of the Luxembourgish association of speech therapists advised the translation grouping in terms of technical terminology.
Procedure
The first stride involved the frontwards translation by two translators independently carried out the translation from the original German version into French. Taking the two translations into account, the same translators proceeded to create one consented single version (V1).
The 2d pace , namely the backward translation, consisted in the independent translation into German of the V1, past the ii other translators. Here again, both experts proceeded to a joint give-and-take in order to consent to a single German version (V2).
At the final step , the backward translation V2 was reviewed past the copyright holder and the translators. At this point, both versions V1 and V2 additionally peer-reviewed by a group of the Luxembourgian association of voice communication therapists.
Phase II: Validation
Linguistic Validation
The preliminary French version, as a result of the translation process, has been tested in a modest sample of patients, in society to verify that all the items were interpreted as expected past the population.
Subjects
Apart from the general inclusion criteria of the Luxembourg Parkinson'south Written report and those mentioned above, the patients must additionally speak French as mother tongue. With these inclusion criteria, seven patients have been selected to undergo the questionnaire for the linguistic validation.
Process
Selected patients were asked to complete the translated version with the "thinking aloud" method. In one case they had completed the French preliminary version in front of the investigator, they were asked to rephrase each item in their ain words, and to add together comments or enquire comprehension questions, if necessary. Patients' comments were recorded and analyzed qualitatively.
Psychometric Validation
The French version of the MDT-PD questionnaire that has previously been validated linguistically was analyzed for test-retest reliability, linguistic communication reliability, internal consistency, and construct validity. For more details, cf. Supplement ane, Table 3 that contains the concluding French MDT-PD version.
Subjects
The patients included had to meet the global study inclusion criteria mentioned above, and additionally, as it is the case for most of the Luxembourgish population, they needed to speak fluently French and German. Furthermore, bones medication should be steady during the examination completions. Enrollment into the study was performed consecutively.
Sample size
Calculations are based on Hong et al. (sixteen), and an evaluation of the understanding between both tests with a Kappa exam.
Given the pooled subjectively estimated prevalence of dysphagia of 35% (1) and an expected difference between two proportions of agreement of 0.ii between examination and retest, 40 responses to the questionnaire (at the second test) would enable a proportion understanding of 0.65 under H0, a proportion agreement of 0.85 under Hane and a Kappa value of 0.64 to be detected with a power 0.80 (2-tailed α = 0.05). If the response rate is 100% the minimal number of subjects should exist 40.
Procedure
The German language version of the MDT-PD questionnaire is already included in the yearly visits of the Grand duchy of luxembourg Parkinson'due south written report. The subgroup of this cohort (divers previously in the section Stage Two: Validation) were asked to complete the MDT-PD at three different steps (cf. Effigy ane). The linguistically validated French MDT-PD questionnaire was sent home before the dispensary visit, and patients were asked to fill information technology out 5–7 days before the visit (FR1). At the clinical visit, the second completion of the French version was performed (FR2). At the engagement of their clinical visit, the patients were given the High german version and asked to fill it out 5–7 days afterward the visit (GE). The engagement of completion was carefully recorded on each questionnaire.
The intervals have been called in order to avoid that subjects base their answers on the ones given at previous fourth dimension points (17, 18).
General Statistical Methodology
Descriptive statistics were produced as means, standard deviations for the quantitative variables, and as total numbers and percentages for the categorical data, every bit appropriate to describe the studied population. Chi2 and/or Freeman–Halton test was used to evaluate differences of categorical variables betwixt groups.
Each of the completion versions (FR1, FR2, and GE), were analyzed for internal consistency and construct validity. As for internal consistency, questions were categorized by the amount of change expected and were compared between the test and the retest versions of the questionnaire. Cronbach'southward alpha was used to compare the French version to the German version. To determine the strength of questionnaire item collinearity, variance aggrandizement factors (VIF) were calculated. Kendall's tau coefficients (t) were calculated to appraise bivariate associations of subjects' answers to the MDT-PD items.
Concerning construct validity, to detect inconsistencies between different conditions of PD, patients were categorized in groups depending on diagnosed type of parkinsonism, H&Y staging, illness duration, cerebral country evaluated by the MoCA test, motor functioning evaluated by the MDS-UPDRS III and difference in the MDT score compared2.
FR1 and FR 2 were compared to analyze exam-retest reliability, and FR1 and GE, respectively, FR2 and GE were compared to assess language reliability.
Examination-retest and linguistic communication reliability were estimated for chiselled questions using percentage agreement and Kappa or Krippendorff'southward blastoff (KALPHA) values3.
Using the FR2 data, exploratory analyses were performed past using interesting questions to create groups of comparing. Patient profiles were and so compared. Cohen's Kappa and/or KALPHA (nineteen, 20) was used to evaluate cyclopedia.
Results
Results Stage I
Members of the translation group performed modifications based on the feedback of the reviewer and the speech therapists. The modifications concerned technical terms (e.1000., avaler instead of déglutir).
The forrad-backward translation method has resulted in a preliminary French version that was agreed on by the four members of the translation group.
Results Stage II
Linguistic Validation
All subjects completed the French MDT-PD successfully. The sample included six patients with IPD and one patient with PSP. Mean historic period was 66.four ± 11.5 years, hateful H&Y phase was 2.2 ± 0.vii, mean MDS-UPDRS III was 35.four ± 13, and mean MoCA score was 25.ane ± 2.6.
The individual reformulations of the items reflected all the intended meaning. Of the 26 items, three items merely (Q3, 19, and 24) were addressed past two patients. The comments concerned scaling of the trouble, but not the interpretation of the particular. As this is related to the global structure of the original German version, it was not changed. Consequently, no modification to the initial version was required.
In conclusion, we delivered a linguistically valid French version of the MDT-PD questionnaire in a French population, enabling usa to undergo a psychometric validation. Fifty-fifty if the smaller sample size could reduce variability in the feedback, the small amount of comments and the high rate on convergent interpretation by all the subjects gave sufficient arguments that the version provided is linguistically valid.
Psychometric Validation
Sample description
In total, 46 patients have been recruited from the Luxembourg Parkinson's Study accomplice fulfilling the inclusion criteria for validation purpose equally mentioned above.
Sex ratio was 37/ix (One thousand/F). The mean MDT was like at the 3 examination versions (p = 0.9354) (cf. Table 1). Additional details of the samples are given in Supplement 2.
Table i
Characteristics of the sample expressed in ways for the clinical data and MDT-PD results.
| Variable | N | Missing data (number of participants) | Mean | Std. Dev. | Min. | Max. |
|---|---|---|---|---|---|---|
| Age (years) | 46 | 0 | 67.98 | 9.96 | 45.47 | 88.25 |
| H&Y | 45 | 1 | 2.20 | 0.76 | i.00 | 5.00 |
| MoCA | 45 | 1 | 26.04 | ii.47 | 18.00 | 30.00 |
| UPDRS III | 43 | 3 | 32.51 | thirteen.67 | seven.00 | 71.00 |
| Disease duration since diagnosis (years) | 45 | one | seven.07 | 4.37 | 1.00 | 20.00 |
| MDT 1 sum score | 46 | 0 | three.63 | 2.35 | −0.79 | 10.47 |
| MDT 2 sum score | 39 | 2 | 3.75 | ii.28 | −0.76 | 8.63 |
| MDT 3 sum score | 35 | 3 | iii.68 | ii.05 | 0.sixteen | eight.63 |
H&Y, Hoehn and Yahr stage; MoCA, Montreal Cognitive Assessment; UPDRS III, Unified Parkinson'due south Illness Rating Scale role 3; MDT 1-three Munich Dysphagia Test—Parkinson'south Disease (1 French version, first test; 2 French version, second test; 3 High german version).
30-9 patients were diagnosed with IPD, while the remaining patients had a diagnosis of aPS or secondary parkinsonism, namely PSP (due north = 3), CBS (n = 1), and VP (n = 1). The 2 remaining patients had a parkinsonism that had non yet been divers.
Response and completion rate
FR1 was completed by all 46 patients, while FR2 was completed past 41 subjects and GE by 38 of the initial group.
In FR2 and GE, the response rate (per examination) was shut to 100% for a bulk of questions except Q22 and Q23 for FR2 and Q10, Q11, Q20, Q23, and Q25 for GE (cf. Supplement three). Consequently, weighted MDT-PD sum score could not be evaluated in two patients for Fr2 and in iii patients for GE due to at least one missing item response (cf. Table 1).
Test-retest reliability
In club to analyze examination-retest reliability, FR1 responses were compared to FR2 responses.
The number of convergent responses was high in the first examination. Up to ane-bespeak difference was observed in 20 items and for a high number of patients in item Q12 (n = ten), otherwise for less than three patients in the other items (Q3, iv, eight, xv, xx, and 21). Two points divergent responses were found for ane to two patients in items Q10, 11, 13, 14, 15, twenty, and 22, every bit well as 3 points divergent responses in items Q24, 25, and 26 (Note that in items Q24–26 the response possibility was but bivariate (yes/no) with cypher or three points. A change in answer beliefs at one or two points difference was not possible. In contrast, items Q1–23 had a four-point scale). No item differed in more than three points.
Agreement between FR1 and FR2 was mis-evaluated with Kappa for some questions due to zero cells and more two categories in the questions. In general, when the Kappa was evaluated, it was in accordance with the KALPHA. There was no dissymmetric evaluation.
Good agreement was found for Q21 for both Kappa (0.82) and KALPHA (0.91). KALPHA was too higher than 0.8 for Q10 (0.84), Q15 (0.80), Q17 (0.84), and Q25 (0.89).
Moderate agreement was found for Q9 (0.77), Q20 (0.74), and Q25 (0.77) with Kappa while simply for Q24 (0.66) with KALPHA. Details can exist found in Supplement iv, Tables 4.1, 4.2 (detail description cf. department Questionnaire Description).
The test-retest reliability in French language confirmed the German linguistic communication validation as shown by KALPHA (hateful – [range] = 0.52 – [0; 0.82] vs. 0.52 – [−0.05; 1]).
Language reliability
Concerning FR1 vs. GE, the divergent responses were less of import in number of patients concerned and therefore less oftentimes compared to the two French versions, except for Q12. But disagreements with one-point departure (for 1–v patients) occurred in some cases every bit well as but four ii-point differences for a single patient each (Q11, 13, 14, and 22). Agreement with KALPHA was very skilful except Q2, Q3, and Q24. Skilful agreement every bit measured past the Kappa and KALPHA was showed for Q4 (0.90 resp. 0.83), Q9 (0.84, resp. 0.84), Q10 (0.84 resp. 0.81), and Q25 (1.0 resp. 1.0). KALPHA was too of skillful understanding for Q16 (0.85) as well as Kappa for Q26 (0.81).
Moderate understanding was concomitantly observed for Q20 (0.79 resp. 0.78), only with Kappa for Q11 (0.74), Q15 (0.73), and Q23 (0.73) while simply with KALPHA for Q18 (0.67). Details are provided in Supplement 4, Tables four.3, 4.4 (item description cf. section Questionnaire Description).
Language reliability was found very adept every bit demonstrated by the KALPHA between the 2d French exam and the original German language questionnaire (mean – [range] = 0.69 – [0; i]).
For the comparing of FR2 with GE, divergent responses occur less oft betwixt FR2 vs. GE compared with both French versions. The number of convergent responses was high. Item Q12 was again observed divergent at one deviation in points for four patients. Nine items were similarly divergent for one patient, 7 items for two patients and i for three patients. A three-points departure was found in item 26 again (0/3 sale) for 3 patients. The divergences seem lower than previously.
The agreement was mostly very high, except for Q2 and Q16. Especially proficient or fantabulous agreement was measured by both Kappa and KALPHA (>0.8/1.0) for Q5, Q9, Q11, Q13, Q18, Q19, Q23, and Q26; merely by Kappa for Q1, Q6, Q15, Q22, Q2, and only by Kalpha for Q4, Q8, Q10, and Q24.
Cyclopedia for a expert agreement was only observed with Kappa for Q6 and Q22 and with KALPHA for Q8 and Q10. For Q1, Q15, and Q25 the agreement was practiced with Kappa and moderate with KALPHA, while for Q4 it was the contrary.
The agreement was moderate for Q12 for both Kappa and KALPHA, for Q7 with Kappa merely, and for Q14 and Q17 for KALPHA. Details are given in Supplement four, Tables 4.five, iv.6.
Figure two shows a graphical overview of strength in response agreement of MDT-PD items for all exam/language version comparisons, and divided for KAPPA and KALPHA.
Strength in patients' response agreement for MDT-PD items. The y-axis shows Kappa and Krippendorf Blastoff coefficients for the different test-retest and language reliability analyses (including French version i and 2, and German version); the x-axis contains the MDT-PD items (Munich Dysphagia Test–Parkinson's Disease, question 1–26). The bar of the histogram is non visible for a KAPPA/KALPHA value of 0.
Internal consistency
The hateful relative modify between both French questionnaires was below 20%, that can exist interpreted as very good, except for items Q12, Q22, and Q26. In full general, the modify was much lower in comparison of FR2 to GE, while the comparing of the FR1 to GE showed slightly higher changes. Details for each item are given in Supplement 5.
The Cronbach Alpha was evaluated globally and for the deletion of 1 particulariv. With regard to the achieved internal consistency of the original German language study (0.91) (4), the overall values for Cronbach Alpha in the present written report was high too, meaning that the boilerplate correlation of items within the test is proficient (0.80 in FR1, 0.84 in FR2, and 0.83 in GE). While the variances of the items are depression, the standardization of the items to a standard difference of 1 before computing the coefficient alpha did not change it much and maintaining its strength (0.84 for FR1 and 0.87 for GE).
The internal consistency was high both in terms of change between items of the questionnaires and as evaluated by the Cronbach Blastoff overall and subsequently deletion of one item (French 1 range = [0.77; 0.82], French ii range = [0.82; 0.86], German range = [0.80; 0.84]).
Most of the MDT-PD items (22/26) reached a Variance Inflation Factor (VIF) value > 4 for almost 1 or even for all three linguistic communication versions demonstrating a stiff collinearity with some in particular: Q1 Chewing/swallowing (upwardly to 56.20), Q6 Food gets stuck (40.twenty), Q4 Multiple swallowing (31.87), Q3 Swallowing trigger (eighteen.81), Q17 Clearing throat (16.ninety), Q8 Coughing while drinking (15.31), Q15 Off times (14.31), Q20 Rinsing later (18.04), Q19 Tiredness within meals (12.93), Q24 Lung infection (12.34), Q25 Loss of weight (12.04), Q21 Single swallowing (xi.84), Q22 Loss of appetite (9.86), Q14 Pills (8.04), and Q10 Inverse voice (7.03). Farther details are provided in Table v.4 of the Supplement 5. Bivariate correlation adding for all MDT-PD items revealed a plurality of moderately positive correlations (t > 0.40). Corresponding correlograms for MDT-PD versions FR1, FR2, and GE are shown in Supplement v, Figure v.1.
Construct validity
No significant difference between diagnoses of parkinsonism (including PD, PD with dementia, PSP, CBS, VP, and unspecified parkinsonism) were establish for FR1, as the mean MDT total score was ranging from ii to 5 with an outlier at 7.five (Cerebrovascular affliction with PD features) (p = 0.39). Furthermore, we did not notice any difference for FR2 (p = 0.ii) nor for GE (p = 0.71) betwixt the different forms of parkinsonism.
Moreover, no pregnant difference between H&Y stages were found for FR1, as means were included in the interval ii.5–5 except for an H&Y stage 3 with a college variability (four patients concerned). The distribution of means was homogeneous with p = 0.73. Concerning FR2 and GE, the means were as well similarly distributed in the dissimilar H&Y stages (p = 0.81 and p = 0.99, respectively).
No significant relationships of MDT-PD scores were establish for the MoCA score (FR1: R2 = 0.017, p = 0.39; FR2: Rtwo = 0.021, p = 0.38; GE: Rtwo = 0.032, p = 0.31), the MDS-UPDRS 3 score (FR1: R2 = 0.007, p = 0.59; FR2: R two = 0.0007, p = 0.88; GE: R 2 = 0.014, p = 0.51) or illness duration (FR1: R 2 = 0.022, p = 0.32; FR2: R 2 = 0.0002, p = 0.93; GE: R two = 0.004, p = 0.69).
The categorization of the disease duration in 5 <, 5–x, and >10 y has not led to significant results concerning the upshot on the MDT scores at the outset, second and third evaluations.
Detailed tables and figures for all clinical parameters assessed are given in Supplement vi.
Word and Conclusion
Based on the results, we were able to create a new language version of the MDT-PD questionnaire in French with very good examination-retest and language reliability every bit well as high internal consistency that tin be used as a non-invasive tool for early detection of dysphagia and aspiration adventure and will be valuable when implementing novel prevention strategies addressing the French speaking population.
With respect to the currently over 220 million French speakers worldwide, including 72 one thousand thousand then-called partial French speakers (expected to ascent to >700 million in 2050 equally a result of population growth later estimation of the Organisation Internationale de la Francophonie), French is an official language in 29 countries and the sixth most widely spoken linguistic communication after Mandarin Chinese, English, Hindi, Castilian and Arabic (and the 2d common language in Europe). At the same time, PD is the second nigh common age-related neurodegenerative disorder just later on Alzheimer'due south disease with an estimate of approximately vii million people affected worldwide and still exponentially increasing beyond the crumbling populations with an estimated doubling until 2040 (21). In addition, pneumonia, specially due to dysphagia with aspiration is considered to exist the leading cause of mortality in all forms of parkinsonism (22, 23). Considering all of the higher up mentioned, a screening tool allowing to discover dysphagia in French speaking PD patients becomes indispensable.
Response rate was high at all three MDT-PD tests, and only a few patients dropped out between the tests. The extent of response agreement was globally high, with a majority of upwardly to one-signal deviation. Yet, the detail Q12 (reflecting a reduced salivation/feeling of dry mouth) showed consequent difference. This might be due to the variable symptom fluctuation depending on hydration, temperature and momentary diet, which might explicate that patients are not consistently responding to this item from 1 time signal to another. For the comparison between the French and German MDT-PD version understanding within questionnaire items was generally higher than for both French versions (especially regarding 2–3 points divergence).
Nosotros assume that the chosen interval for MDT-PD completion dates (v–7 days) was optimal and too long enough to exclude that the answers on previous versions can be immediately remembered. In the literature exam-retest intervals for PD related instruments/questionnaires usually vary between 2 days up to >1 calendar month without any statistically significant difference, but slightly higher values for 14 days or less (17). Even if we may not suspect a learning event per se in this type of questionnaire (as this is the instance in cognitive tests), it might be possible that patients may want to respond consistently from ane to another fourth dimension indicate. The other way effectually, a maximum limit of 7 days between 2 examination completions was intended to preclude an reply behavior completely different to the previous exam due to changes in the disease status, e.g., progression of axial symptoms. In addition, there was no modification of medication during the report period.
More generally (and related to Q15), swallowing improvement due to dopaminergic medication is controversially discussed. Although levodopa responsiveness of dysphagia symptoms was formerly considered negligible (24, 25), there are more than recent studies showing (curt-term) changes in swallowing operation due to oral L-Dopa-intake, subcutaneous apomorphine application, or transdermal rotigotine delivery in some patients (26–29).
In the literature information technology is presumed that the gastrointestinal organisation does play a multifaceted role in PD, outset with the presence of pervasive α-synuclein deposition in the alimentary canal that is involved in the pathogenesis of the disease, and ending with implications of the organization affecting several complications including drooling and swallowing bug (30). This implicates the high priority of futurity studies elucidating the role of the gastrointestinal system on the pathological progression of PD. While it is estimated that the bulk of dysphagic PD patients are at progressed disease stage, there are few studies discussing dysphagia every bit an early symptom, prodromal or even the showtime sign of PD. Nevertheless, early on, astringent dysphagia is considered to be more relevant in the Parkinsonian variant of MSA (MSA-P) (31).
For FR1 37% of report patients has been identified as dysphagia positive by the weighted MDT-PD screening questionnaire (41% for FR2 and 46% for GE). Table two shows the distribution of dysphagia severity assessed by MDT-PD for all three language versions in patients with PD and aPS (additional tables containing distribution and descriptive statistics of MDT-PD score characteristics is provided in Supplement seven). Although these rates are similar to the relatively low percentage of PD patients subjectively lament about swallowing problems in comparison to objectively assessed dysphagia via instrumental diagnostic approaches as shown in other studies (one, 32, 33), this is an unexpected high rate with regard to the very mild disease stage in the present written report (hateful H&Y of 2.2).
Table 2
Distribution of dysphagia positive/negative screened patients by MDT-PD, separated for patients with PD and aPD.
| MDT-PD questionnaire | MDT-PD score | PD | Proportion from the participant group (%) | aPS + secondary PS | Proportion from the participant group (%) | All cohort (PD + aPS + secondary PS) | Proportion from the accomplice (%) |
|---|---|---|---|---|---|---|---|
| FR1 | Due north | 39 | 100 | 7 | 100 | 46 | 100 |
| <3.65 | 26 | 67 | 3 | 43 | 29 | 63 | |
| ≥iii.65 | 5 | 13 | 2 | 28.5 | vii | 15 | |
| ≥4.79 | 8 | xx | 2 | 28.five | 10 | 22 | |
| FR2 | North | 34 | 100 | v | 100 | 39 | 100 |
| <three.65 | 21 | 62 | 2 | 40 | 23 | 59 | |
| ≥three.65 | 3 | 9 | ane | 20 | iv | 10 | |
| ≥four.79 | 10 | 29 | ii | 40 | 12 | 31 | |
| GE | North | 31 | 100 | 4 | 100 | 35 | 100 |
| <3.65 | 18 | 58 | ane | 25 | 19 | 54 | |
| ≥three.65 | four | 13 | iii | 75 | vii | twenty | |
| ≥4.79 | ix | 29 | 0 | 0 | 9 | 26 |
<iii.65 No noticeable dysphagia; ≥3.65 Noticeable, oropharyngeal dysphagia; ≥4.79 Dysphagia with hazard of aspiration; Munich Dysphagia Test—Parkinson'southward Disease, MDT-PD (FR1/FR2, French version exam 1/2; GE, High german version); PD, Parkinson'due south illness; aPS, atypical parkinsonian syndrome; absolute numbers of patients (percentages considering the relative proportions for PD vs. aPS vs. total accomplice). Bold values represents total number of values per grouping.
Given the fact that there was no significant correlation between the MDT-PD score and characteristics of investigated clinical parameters (disease stage, disease elapsing, motor functions, cognitive performance or diagnose of parkinsonism), nosotros are confident to pursue the hypothesis that dysphagia could be considered equally an early on symptom in both PD and aPS.
While using the French version of the MDT questionnaire we were not able to show distinctive frequencies of patients with dysphagia between the different types of parkinsonism or the unlike levels of motor disease progression tested (Hoehn&Yahr, UPDRSIII, disease duration). According to the analyses carried out and so far, it did not discriminate unlike level of illness or symptoms. It could be a consequence of the small sample size especially in the sub groups, every bit the majority of participants were idiopathic PD patients. But given the fact that the underlying mechanism of dysphagia progression are still unclear, the present results of the correlation analyses thus assume detail significance. However, the original German questionnaire was designed for the detection of noticeable dysphagia for early on stage of PD and an Anova analysis of 38 idiopathic PD patients provided similar results for each variable, where the construct validity was tested (4). Therefore, construct validity should be further explored every bit the sample used in the current research may not be heterogeneous plenty. This is currently tested in our subsequent diagnostic validation study too as for other linguistic communication translations/cultural adaptations of the MDT-PD.
Usually, dysphagia is associated with clinical parameters similar higher H&Y phase, relevant loss of body weight, drooling/sialorrhea, or dementia (6). The increasing of swallowing damage with affliction stage therefore has been expected, only fifty-fifty meaning dysphagia symptoms with penetration or aspiration for at to the lowest degree one consistency has been observed in early PD stages with H&Y of 2 or lower among other recent cohort studies (34). Regarding the association between cognitive impairment and dysphagia we are enlightened of the fact, that we excluded report subjects with MoCA <17 toward securing deep comprehension performance and assume a positive correlation under existent-life conditions.
In general, early on screening for dysphagia should be taken into consideration in neurological indicate of care to enable identification of swallowing impairments including the very early on oropharyngeal symptoms and particularly to prevent severe clinical complications or threats to wellness as well as to quality of life. For certain, in that location is a limitation for the usage of the MDT-PD questionnaire in daily do amidst PD patients with astringent dementia or astringent depression equally these cerebral and neuropsychological states may have a negative influence on the answering behavior and also for the prediction of the examination result. The ability of fairly comprehending and answering questionnaire items should be tested therefore prior to the completion of patient-centered, self-reported questionnaires.
In dissimilarity to a recently published clinical study where among others, mismatched parameter classifications were unfortunately applied for the comparison between the three different MDT-PD categories and the dysphagia estimations based on a single diagnostic parameter merely (penetration-aspiration calibration for the consistency water, PAS H2O; more than details are provided in Supplement 8) (35), the results of this project, being in line with a simultaneously completed study validating the new Italian version of MDT-PD. These findings underline both the very good psychometric properties of the patient questionnaire and its power to discriminate between "non-dysphagic" PD patients and dysphagic individuals with "whatsoever oropharyngeal symptoms," or even with "chance of aspiration." In add-on, the stiff positive correlation between MDT-PD score and FEES results (incl. PAS H2O only) was reconfirmed.
Subsequently, the hypothesis above will exist further addressed by the follow-up diagnostic validation of the French MDT-PD version, where all included patients with diagnosed parkinsonism and positively screened past the MDT-PD questionnaire volition undergo CSA and FEES (cf. Effigy 1, phase three) complying standardized and Parkinson-specific protocols (four). Post-obit this promising first phases, clinical examinations consisting of CSA and FEES should enable us to verify the diagnostic quality of the French MDT-PD.
Data Availability Statement
The datasets for this manuscript are non publicly available every bit they are linked to the Grand duchy of luxembourg Parkinson's Report and its internal regulations. Requests to access the datasets should exist directed to MV, mean of contact via email: ul.hil@tnalliav.lehcim.
Ethics Statement
This written report was carried out in accord with the recommendations of the National Ideals Board (CNER Ref: 201407/13) and Information Protection Commission (CNPD Ref: 446/2017. All subjects gave written informed consent in accordance with the Declaration of Helsinki. The protocol was canonical past the National Ethics Board. A clinical steering commission composed of different health professionals from Luxembourg supervises the recruitment procedures.
Author Contributions
JS: enquiry projection (conception, organization, and execution), statistical analyses (blueprint, review, and critique), and manuscript (writing of 1st draft). MV: statistical analyses (design and execution) and manuscript (writing, review, and critique). GH: inquiry project (organization and execution), statistical analyses (review and critique), and manuscript (writing, review, and critique). LP and LS: inquiry projection (neurological examinations) and manuscript (writing, review, and critique). CP: inquiry projection (neuropsychological examinations). RK: research projection (conception and organization) and manuscript (review and critique).
Disharmonize of Involvement
RK serves as Editorial Board Member of the European Journal of Clinical Investigation, Parkinsonism and Related Disorders and Journal of Neural Transmission. RK has received research grants from Fonds National de Recherche de Grand duchy of luxembourg (FNR; PEARL [FNR/P13/6682797/Krüger] and NCER-PD), the High german Research Council (DFG; KR2119/8-one), the Michael J. Fox Foundation, the European Union's Joint Program-Neurodegenerative Diseases (JPND; COURAGE-PD), the European Union's Horizon 2020 research and innovation programme (No. 692320), and the Federal Ministry building for Education and Research (BMBF; Mito-PD 031 A 430 A), likewise as speaker's honoraria and/or travel grants from Abbvie, Zambon, and Medtronic. RK participated as PI or site-PI for industry sponsored clinical trials without receiving honoraria. JS and RK received funding by the Fonds Amélie and Hélène de Fabribeckers, the Fondation Roi Baudouin, Claudie Stein-Lambert also as by other private donors to execute the presented study. JS also received a postdoctoral fellowship by the University of Luxembourg and works as a visiting researcher at the LCSB. The remaining authors declare that the research was conducted in the absence of whatever commercial or financial relationships that could be construed as a potential disharmonize of interest.
Acknowledgments
We would like to give special cheers to all participants in the report. Additionally, we are very grateful for all received funding and private donations that enabled united states to carry out the project.
Furthermore, we acknowledge the articulation effort of the NCER-PD consortium members generally contributing to the Luxembourg Parkinson's Study as listed below:
Aguayo, Gloria; Allen, Dominic; Ammerlann, Wim; Aurich, Maike; Baldini, Federico; Balling, Rudi; Banda, Peter; Beaumont, Katy; Becker, Regina; Berg, Daniela; Betsou, Fay; Binck, Sylvia; Bisdorff, Alexandre; Bobbili, Dheeraj; Brockmann, Kathrin; Calmes, Jessica; Castillo, Lorieza; Diederich, Nico; Dondelinger, Rene; Esteves, Daniela; Ferrand, Jean-Yves; Fleming, Ronan; Gantenbein, Manon; Gasser, Thomas; Gawron, Piotr; Geffers, Lars; Giarmana, Virginie; Glaab, Enrico; Gomes, Clarissa P.C.; Goncharenko, Nikolai; Graas, Jérôme; Graziano, Mariela; Groues, Valentin; Grünewald, Anne; Gu, Wei; Hammot, Gaël; Hanff, Anne-Marie; Hansen, Linda; Hansen, Maxime; Haraldsdöttir, Hulda; Heirendt, Laurent; Herbrink, Sylvia; Hertel, Johannes; Herzinger, Sascha; Heymann, Michael; Hiller, Karsten; Hipp, Geraldine; Hu, Michele; Huiart, Laetitia; Hundt, Alexander; Jacoby, Nadine; Jarosław, Jacek; Jaroz, Yohan; Kolber, Pierre; Krüger, Rejko; Kutzera, Joachim; Landoulsi, Zied; Larue, Catherine; Lentz, Roseline; Liepelt, Inga; Liszka, Robert; Longhino, Laura; Lorentz, Victoria; Mackay, Clare; Maetzler, Walter; Marcus, Katrin; Marques, Guilherme; Martens, January; Mathay, Conny; Matyjaszczyk, Piotr; May, Patrick; Meisch, Francoise;Menster, Myriam;Minelli, Maura, Mittelbronn, Michel; Mollenhauer, Brit; Mommaerts, Kathleen; Moreno, Carlos; Mühlschlegel, Friedrich; Nati, Romain; Nehrbass, Ulf; Nickels, Sarah; Nicolai, Beatrice; Nicolay, Jean-Paul; Noronha, Alberto; Oertel, Wolfgang; Ostaszewski, Marek; Pachchek, Sinthuja; Pauly, Claire; Pavelka, Lukas; Perquin, Magali; Reiter, Dorothea; Rosety, Isabel; Rump, Kirsten; Sandt, Estelle; Satagopam, Venkata; Schlesser, Marc; Schmitz, Sabine; Schmitz, Susanne; Schneider, Reinhard; Schwamborn, Jens; Schweicher, Alexandra; Simons, Janine; Stute, Lara; Thiele, Ines; Thinnes, Cyrille; Trefois, Christophe; Trezzi, Jean-Pierre; Vaillant, Michel; Vasco, Daniel; Vyas, Maharshi; Wade-Martins, Richard; Wilmes, Paul.
1(Q1) I have difficulties with the chewing and swallowing of solid/fibrous/crumbly food (e.g., apples, meat, cracker/chips).
(Q2) During meals, food/liquid escapes from the oral cavity (or the olfactory organ).
(Q3) I discover it difficult to directly/quickly start the swallowing process when taking in liquids or food.
(Q4) For the complete swallowing of food/liquids I need to swallow multiple times in a row.
(Q5) Nutrient residues remain in my oral fissure after swallowing.
(Q6) During the swallowing process, nutrient gets stuck in my throat/esophagus (possibly I even have to choke).
(Q7) During (or after) eating nutrient I accept to hawk/coughing.
(Q8) During (or afterward) drinking liquids (or eating soup) I have to hawk/cough.
(Q9) It happens that I have difficulties breathing/a sense of suffocation when swallowing nutrient or liquids.
(Q10) Correct afterwards eating food/drinking liquids my voice has inverse (due east.g., coated/weakened/"wet"/"gargling").
(Q11) I have increased amount of saliva in my mouth/I consume my saliva too rarely or I have full general bug swallowing my saliva/drooling.
(Q12) I have a very dry out mouth/not enough saliva.
(Q13) Information technology happens that I cough or have trouble breathing because I have choked on my saliva/saliva went into my trachea.
(Q14) I have problems swallowing pills.
(Q15) During the off-phases (off-drug-state/declining levodopa levels) I take more difficulties to eat.
(Q16) I avoid specific foods or textures that often make me choke (eastward.g., nuts, crumb block, liquid-filled pralines, and raw vegetable salads).
(Q17) Information technology is hard for me to hawk/coughing after I choke in order to clear my throat.
(Q18) Present, information technology takes me more fourth dimension to consume than information technology used to (e.k., because I have to chew longer/foods are longer in my rima oris due to longer grooming time or more than careful swallowing).
(Q19) Information technology happens that I become tired during meals (or fifty-fifty fall comatose) and don't finish chewing and swallowing my food.
(Q20) During meals I take to have liquids to "flush down" the nutrient in order to exist able to ameliorate consume.
(Q21) I tin can merely eat liquids in small lips.
(Q22) I have a reduced appetite or pleasure to consume than before (sense of gustatory modality and scent are potentially affected).
(Q23) I have issues, such as heartburn/frequent burping, sense of lump in the throat/esophagus, sense of pressure backside the breastbone.
(Q24) Within the concluding year I had a lung infection or unclear fever-infections.
(Q25) I involuntarily loose trunk weight.
(Q26) I drink <50 oz. of liquid during a given day (equal to suggested minimum of seven–eight spectacles/cups water, juice, tea, coffee, and soup).
2A Cronbach blastoff > 0.8 was considered every bit proficient, >0.ix excellent, while alpha <0.vii meant very unreliable results.
3Intraclass correlation coefficient was estimated for detached data. Cohen's Kappa and KALPHA coefficients are reliability measures developed to evaluate the agreement amid observers, coders, judges, raters, annotators or measuring devices. While the Kappa applies but to squared tables (2 × two, 3 × 3, …), KALPHA tin can be used when there are some unmeasured categories. Good agreement is considered for a Kappa > 0.eight and Alpha > 0.8. Alpha > 0.667 and <0.800 is moderate agreement while below 0.667 understanding is discarded. Kappa <0.7 is considered every bit bad agreement.
4With a maximum of 1, 0.70 has been suggested equally an acceptable, >0.eight as good, and >0.9 as excellent reliability coefficient.
Funding. This work was supported by grants from the Luxembourg National Research Fund (FNR) inside the National Center of Excellence in Research on Parkinson's disease (NCER-PD) and the PEARL plan (FNR; FNR/P13/6682797 to RK) too as past the European Union's Horizon 2020 research and innovation program under Grant Agreement No. 692320 (WIDESPREAD; CENTRE-PD; Grant Understanding No. 692320; Centre-PD to RK). Further grants that supported this work were the Fonds Amélie and Hélène de Fabribeckers and Fondation Roi Baudouin, and individual donations, especially nosotros would like to thank Mme. Claudie Stein-Lambert.
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