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      Treatment fidelity in a pragmatic clinical trial of music therapy for premature infants and their parents: the LongSTEP study

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          Abstract

          Background

          Treatment fidelity (TF) refers to methodological strategies used to monitor and enhance the reliability and validity of interventions. We evaluated TF in a pragmatic RCT of music therapy (MT) for premature infants and their parents.

          Methods

          Two hundred thirteen families from seven neonatal intensive care units (NICUs) were randomized to receive standard care, or standard care plus MT during hospitalization, and/or during a 6-month period post-discharge. Eleven music therapists delivered the intervention. Audio and video recordings from sessions representing approximately 10% of each therapists’ participants were evaluated by two external raters and the corresponding therapist using TF questionnaires designed for the study (treatment delivery (TD)). Parents evaluated their experience with MT at the 6-month assessment with a corresponding questionnaire (treatment receipt (TR)). All items as well as composite scores (mean scores across items) were Likert scales from 0 (completely disagree) to 6 (completely agree). A threshold for satisfactory TF scores (≥4) was used in the additional analysis of dichotomized items.

          Results

          Internal consistency evaluated with Cronbach’s alpha was good for all TF questionnaires ( α ≥ 0.70), except the external rater NICU questionnaire where it was slightly lower ( α 0.66). Interrater reliability measured by intraclass correlation coefficient (ICC) was moderate (NICU 0.43 (CI 0.27, 0.58), post-discharge 0.57 (CI 0.39, 0.73)). Gwet’s AC for the dichotomized items varied between 0.32 (CI 0.10, 0.54) and 0.72 (CI 0.55, 0.89). Seventy-two NICU and 40 follow-up sessions with 39 participants were evaluated. Therapists’ mean (SD) TD composite score was 4.88 (0.92) in the NICU phase and 4.95 (1.05) in the post-discharge phase. TR was evaluated by 138 parents. The mean (SD) score across intervention conditions was 5.66 (0.50).

          Conclusions

          TF questionnaires developed to assess MT in neonatal care showed good internal consistency and moderate interrater reliability. TF scores indicated that therapists across countries successfully implemented MT in accordance with the protocol. The high treatment receipt scores indicate that parents received the intervention as intended. Future research in this area should aim to improve the interrater reliability of TF measures by additional training of raters and improved operational definitions of items.

          Trial registration

          Longitudinal Study of music Therapy’s Effectiveness for Premature infants and their caregivers – “LongSTEP”. ClinicalTrials.gov Identifier: NCT03564184. Registered on June 20, 2018

          Supplementary Information

          The online version contains supplementary material available at 10.1186/s13063-022-06971-w.

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          Most cited references44

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          Coefficient alpha and the internal structure of tests

          Psychometrika, 16(3), 297-334
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            Making sense of Cronbach's alpha

            Medical educators attempt to create reliable and valid tests and questionnaires in order to enhance the accuracy of their assessment and evaluations. Validity and reliability are two fundamental elements in the evaluation of a measurement instrument. Instruments can be conventional knowledge, skill or attitude tests, clinical simulations or survey questionnaires. Instruments can measure concepts, psychomotor skills or affective values. Validity is concerned with the extent to which an instrument measures what it is intended to measure. Reliability is concerned with the ability of an instrument to measure consistently. 1 It should be noted that the reliability of an instrument is closely associated with its validity. An instrument cannot be valid unless it is reliable. However, the reliability of an instrument does not depend on its validity. 2 It is possible to objectively measure the reliability of an instrument and in this paper we explain the meaning of Cronbach’s alpha, the most widely used objective measure of reliability. Calculating alpha has become common practice in medical education research when multiple-item measures of a concept or construct are employed. This is because it is easier to use in comparison to other estimates (e.g. test-retest reliability estimates) 3 as it only requires one test administration. However, in spite of the widespread use of alpha in the literature the meaning, proper use and interpretation of alpha is not clearly understood. 2 , 4 , 5 We feel it is important, therefore, to further explain the underlying assumptions behind alpha in order to promote its more effective use. It should be emphasised that the purpose of this brief overview is just to focus on Cronbach’s alpha as an index of reliability. Alternative methods of measuring reliability based on other psychometric methods, such as generalisability theory or item-response theory, can be used for monitoring and improving the quality of OSCE examinations 6 - 10 , but will not be discussed here. What is Cronbach alpha? Alpha was developed by Lee Cronbach in 1951 11 to provide a measure of the internal consistency of a test or scale; it is expressed as a number between 0 and 1. Internal consistency describes the extent to which all the items in a test measure the same concept or construct and hence it is connected to the inter-relatedness of the items within the test. Internal consistency should be determined before a test can be employed for research or examination purposes to ensure validity. In addition, reliability estimates show the amount of measurement error in a test. Put simply, this interpretation of reliability is the correlation of test with itself. Squaring this correlation and subtracting from 1.00 produces the index of measurement error. For example, if a test has a reliability of 0.80, there is 0.36 error variance (random error) in the scores (0.80×0.80 = 0.64; 1.00 – 0.64 = 0.36). 12 As the estimate of reliability increases, the fraction of a test score that is attributable to error will decrease. 2 It is of note that the reliability of a test reveals the effect of measurement error on the observed score of a student cohort rather than on an individual student. To calculate the effect of measurement error on the observed score of an individual student, the standard error of measurement must be calculated (SEM). 13 If the items in a test are correlated to each other, the value of alpha is increased. However, a high coefficient alpha does not always mean a high degree of internal consistency. This is because alpha is also affected by the length of the test. If the test length is too short, the value of alpha is reduced. 2 , 14 Thus, to increase alpha, more related items testing the same concept should be added to the test. It is also important to note that alpha is a property of the scores on a test from a specific sample of testees. Therefore investigators should not rely on published alpha estimates and should measure alpha each time the test is administered. 14 Use of Cronbach’s alpha Improper use of alpha can lead to situations in which either a test or scale is wrongly discarded or the test is criticised for not generating trustworthy results. To avoid this situation an understanding of the associated concepts of internal consistency, homogeneity or unidimensionality can help to improve the use of alpha. Internal consistency is concerned with the interrelatedness of a sample of test items, whereas homogeneity refers to unidimensionality. A measure is said to be unidimensional if its items measure a single latent trait or construct. Internal consistency is a necessary but not sufficient condition for measuring homogeneity or unidimensionality in a sample of test items. 5 , 15 Fundamentally, the concept of reliability assumes that unidimensionality exists in a sample of test items 16 and if this assumption is violated it does cause a major underestimate of reliability. It has been well documented that a multidimensional test does not necessary have a lower alpha than a unidimensional test. Thus a more rigorous view of alpha is that it cannot simply be interpreted as an index for the internal consistency of a test. 5 , 15 , 17 Factor Analysis can be used to identify the dimensions of a test. 18 Other reliable techniques have been used and we encourage the reader to consult the paper “Applied Dimensionality and Test Structure Assessment with the START-M Mathematics Test” and to compare methods for assessing the dimensionality and underlying structure of a test. 19 Alpha, therefore, does not simply measure the unidimensionality of a set of items, but can be used to confirm whether or not a sample of items is actually unidimensional. 5 On the other hand if a test has more than one concept or construct, it may not make sense to report alpha for the test as a whole as the larger number of questions will inevitable inflate the value of alpha. In principle therefore, alpha should be calculated for each of the concepts rather than for the entire test or scale. 2 , 3 The implication for a summative examination containing heterogeneous, case-based questions is that alpha should be calculated for each case. More importantly, alpha is grounded in the ‘tau equivalent model’ which assumes that each test item measures the same latent trait on the same scale. Therefore, if multiple factors/traits underlie the items on a scale, as revealed by Factor Analysis, this assumption is violated and alpha underestimates the reliability of the test. 17 If the number of test items is too small it will also violate the assumption of tau-equivalence and will underestimate reliability. 20 When test items meet the assumptions of the tau-equivalent model, alpha approaches a better estimate of reliability. In practice, Cronbach’s alpha is a lower-bound estimate of reliability because heterogeneous test items would violate the assumptions of the tau-equivalent model. 5 If the calculation of “standardised item alpha” in SPSS is higher than “Cronbach’s alpha”, a further examination of the tau-equivalent measurement in the data may be essential. Numerical values of alpha As pointed out earlier, the number of test items, item inter-relatedness and dimensionality affect the value of alpha. 5 There are different reports about the acceptable values of alpha, ranging from 0.70 to 0.95. 2 , 21 , 22 A low value of alpha could be due to a low number of questions, poor inter-relatedness between items or heterogeneous constructs. For example if a low alpha is due to poor correlation between items then some should be revised or discarded. The easiest method to find them is to compute the correlation of each test item with the total score test; items with low correlations (approaching zero) are deleted. If alpha is too high it may suggest that some items are redundant as they are testing the same question but in a different guise. A maximum alpha value of 0.90 has been recommended. 14 Summary High quality tests are important to evaluate the reliability of data supplied in an examination or a research study. Alpha is a commonly employed index of test reliability. Alpha is affected by the test length and dimensionality. Alpha as an index of reliability should follow the assumptions of the essentially tau-equivalent approach. A low alpha appears if these assumptions are not meet. Alpha does not simply measure test homogeneity or unidimensionality as test reliability is a function of test length. A longer test increases the reliability of a test regardless of whether the test is homogenous or not. A high value of alpha (> 0.90) may suggest redundancies and show that the test length should be shortened. Conclusions Alpha is an important concept in the evaluation of assessments and questionnaires. It is mandatory that assessors and researchers should estimate this quantity to add validity and accuracy to the interpretation of their data. Nevertheless alpha has frequently been reported in an uncritical way and without adequate understanding and interpretation. In this editorial we have attempted to explain the assumptions underlying the calculation of alpha, the factors influencing its magnitude and the ways in which its value can be interpreted. We hope that investigators in future will be more critical when reporting values of alpha in their studies.
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              Understanding interobserver agreement: the kappa statistic.

              Items such as physical exam findings, radiographic interpretations, or other diagnostic tests often rely on some degree of subjective interpretation by observers. Studies that measure the agreement between two or more observers should include a statistic that takes into account the fact that observers will sometimes agree or disagree simply by chance. The kappa statistic (or kappa coefficient) is the most commonly used statistic for this purpose. A kappa of 1 indicates perfect agreement, whereas a kappa of 0 indicates agreement equivalent to chance. A limitation of kappa is that it is affected by the prevalence of the finding under observation. Methods to overcome this limitation have been described.
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                Author and article information

                Contributors
                torasoderstrom@gmail.com
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                3 March 2023
                3 March 2023
                2023
                : 24
                : 160
                Affiliations
                [1 ]GRID grid.509009.5, GAMUT – The Grieg Academy Music Therapy Research Centre, NORCE Norwegian Research Centre AS, ; Bergen, Norway
                [2 ]GRID grid.509009.5, Regional Centre for Child and Youth Mental Health and Child Welfare, NORCE Norwegian Research Centre AS, ; Bergen, Norway
                [3 ]GRID grid.10420.37, ISNI 0000 0001 2286 1424, Department of Clinical and Health Psychology, , University of Vienna, ; Vienna, Austria
                [4 ]GRID grid.509009.5, NORCE Energy, Norwegian Research Centre AS, ; Bergen, Norway
                [5 ]GRID grid.7914.b, ISNI 0000 0004 1936 7443, Department of Mathematics, , University of Bergen, ; Bergen, Norway
                [6 ]GRID grid.8585.0, ISNI 0000 0001 2370 4076, Department of Clinical and Health Psychology, Faculty of Social Sciences, , Institute of Psychology, University of Gdańsk, ; Gdańsk, Poland
                [7 ]GRID grid.7914.b, ISNI 0000 0004 1936 7443, GAMUT – The Grieg Academy Music Therapy Research Centre, , University of Bergen, ; Bergen, Norway
                Author information
                http://orcid.org/0000-0003-0317-6442
                Article
                6971
                10.1186/s13063-022-06971-w
                9983212
                36869392
                2d8833a4-30cf-430c-b905-963fda4525d4
                © The Author(s) 2023

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

                History
                : 1 July 2022
                : 28 November 2022
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100005416, Norges Forskningsråd;
                Award ID: 273534
                Categories
                Methodology
                Custom metadata
                © The Author(s) 2023

                Medicine
                research methods,fidelity,treatment fidelity,randomized controlled trial,pragmatic trial,multinational trial,non-pharmacological interventions,music therapy,premature infant,parent-infant bonding

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