|- candidate number||25290|
|- NTR Number||NTR6088|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||15-sep-2016|
|- Secondary IDs||16-084 MEC ZWH|
|- Public Title||Does a patient-based version of the Constant-Murley score produce similar and reliable results, as compared to the original clinician-based Constant-Murley score?|
|- Scientific Title||Validity and reproducibility of the Dutch patient-derived Constant-Murley score|
|- hypothesis||To evaluate the validity, reproducibility and scale functioning of the Dutch clinician-based Constant-Murley (CM) score and of a Dutch patient-derived Constant-Murley score in patients with shoulder arthroplasty.|
To define the smallest detectable change (SDC) and minimal important change (MIC) of both the clinician-derived and patient-derived CM score in patients with shoulder arthroplasty
|- Healt Condition(s) or Problem(s) studied||Shoulder disorders , Shoulder prothesis, Arthrodesis|
|- Inclusion criteria||Age 18 years or older|
Scheduled to undergo shoulder arthroplasty
Able to speak and write Dutch
Willing to participate
Able to provide written informed consent
|- Exclusion criteria||Cognitive impairment|
Difficulty with the Dutch language
|- mec approval received||no|
|- multicenter trial||yes|
|- planned startdate ||26-sep-2016|
|- planned closingdate|
|- Target number of participants||125|
|- Interventions||T0: clinician-based CM score, patient-based CM score, Oxford Shoulder Score (OSS), Simple Shoulder Test (SST), Numeric Rating Scale (NRS), EuroQoL-5D (EQ-5D)
T1: clinician-based CM score, patient-based CM score, anchorquestion
T2: clinician-based CM score, patient-based CM score, Oxford Shoulder Score (OSS), Simple Shoulder Test (SST), Numeric Rating Scale (NRS), EuroQoL-5D (EQ-5D), anchorquestion
|- Primary outcome||The main study parameters are: |
•Validity of both CM scores
oConstruct validity of both CM scores
•Reproducibility of both CM scores
oExact agreement on ordinal item scores of both CM scores between T0 and T1
oSEM for continuous item scores and total composite score of both CM scores between T0 and T1
oExact and adjacent agreement between both CM ordinal item scores at T0 and T2
oSEM for continuous item scores and total composite score between both CM scores at T0 and T2
oDiscrimination a and threshold b parameters of each item (+ ICC) and answer category (+ CRC) in both CM scores at T0 and T2
oIIF for each item in both CM scores
oSIF for both CM scores
|- Secondary outcome||•Smallest Detectable Change (SDC) for the continuous item scores and total composite score of both CM scores between T0 and T1|
•SDC for the continuous item scores and total composite score between both CM scores at T0 and T2
•Minimal Clinically Important Difference (MCID) of both CM scores
|- Timepoints||T0: within 6 months pre-operatively|
T1: 2 weeks after T0
T2: 6 months post-operatively
The treating orthopaedic surgeon will perform the clinician-based CM score during a clinic visit. All other questionnaires will be completed by the patients, either on paper or digital (according to patient preference)
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||M.Sc. Brechtje Hesseling|
|- CONTACT for SCIENTIFIC QUERIES||M.Sc. Brechtje Hesseling|
|- Sponsor/Initiator ||Reinier de Graaf Groep, afdeling orthopedie|
(Source(s) of Monetary or Material Support)
|Reinier de Graaf Gasthuis, Delft |
|- Brief summary||SUMMARY|
Rationale: The Constant-Murley (CM) score is one of the most commonly used scoring systems for shoulder arthroplasty, combining assessment by the clinician (range of movement (ROM) and strength) and by the patient (pain and activities of daily living (ADL)).
A patient-based CM score was developed in the United Kingdom (UK) and tested for its reliability in a population of patients with mixed diagnoses, not including shoulder arthroplasty.
However, both scores have not been evaluated in a Dutch setting and there are varied reports regarding the reliability of the CM score, justifying further analysis alongside translation and validation of both scores in Dutch. Rating scale analysis with item response theory (IRT) modeling can evaluate the performance of items and overall scores more thoroughly.
Objective: To assess the validity, reproducibility and performance of the clinician-based and patient-based CM scores, and to determine the smallest detectable change (SDC) and minimal clinically important difference (MCID) of both CM scores in a population of patients undergoing shoulder arthroplasty.
Study design: Clinimetric study
Study population: Patients scheduled to undergo shoulder arthroplasty, aged 18 years and older.
Main study parameters/endpoints: The main study parameters are the construct validity, reproducibility (exact and adjacent agreement for ordinal scores, standard error of measurement (SEM) and smallest detectable change (SDC) for continuous scores) and performance of the separate items and overall scores assessed with IRT modeling.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: We expect no risks associated with participation, due to the nature of the study (filling out questionnaires and undergoing physical assessment in the same manner as routine care). The extra burden placed on patients will consist of two extra visits to the orthopaedic surgeon (T1 and T2) for administration of the clinician-based score, completing four extra questionnaires at baseline, completing two questionnaires at T1 and completing seven questionnaires at T2.
The MEC declared that ethical approval for this study is not necessary.
|- Main changes (audit trail)|
|- RECORD||15-sep-2016 - 19-nov-2017|