PONE-D-24-30955Speech-in-noise, psychosocial, and heart rate variability outcomes of group singing or audiobook club interventions for older adults with unaddressed hearing loss: a SingWell Project multisite, randomized controlled trial, registered report protocolPLOS ONE

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Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions?

The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field.

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

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2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses?

The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory.

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

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3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable?

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

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4. Have the authors described where all data underlying the findings will be made available when the study is complete?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

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Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

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6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics.

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(Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: Important note: This review pertains only to ‘statistical aspects’ of the study and so ‘clinical aspects’ [like medical importance, relevance of the study, ‘clinical significance and implication(s)’ of the whole study, etc.] are to be evaluated [should be assessed] separately/independently. Further please note that any ‘statistical review’ is generally done under the assumption that study specific methodological [as well as execution] issues are perfectly taken care of by the investigator(s). This review is not an exception to that and so does not cover clinical aspects {however, seldom comments are made only if those issues are intimately / scientifically related & intermingle with ‘statistical aspects’ of the study}. Agreed that ‘statistical methods’ are used as just tools here, however, they are vital part of methodology [and so should be given due importance]. I look at the manuscript in/with statistical view point, other reviewer(s) look(s) at it with different angle so that in totality the review is very comprehensive. However, there should be efforts from authors side to improve (may be by taking clues from reviewer’s comments). Therefore, please do not limit the revision only (with respect) to comments made here.

COMMENTS: Because the study & manuscript is excellent in all aspects, there is hardly anything to point-out. However, I have different opinion regarding a few (only two) issues which are given below:

When lines 599-602 it is stated that “Given the sample size and random assignment to group, we assume that covariates such as age, gender, education, musical training/background, credibility, and expectation will be evenly distributed across the participants. Thus, we expect equivalence between participants and their randomly assigned intervention” then why further said “To test this assumption, we will use a well-known technique to test for equivalence, the Bayesian t-test”? Test proposed is appropriate and reference quoted [Stefan AM, Gronau QF, Schönbrodt FD, Wagenmakers EJ. A tutorial on Bayes Factor Design Analysis using an informed prior. Behav Res Methods. 2019;51: 1042–1058] is nice. However, it is often very rightly advised that when random allocation/assignment is used/done any statistical comparison of baseline characteristics is not necessary. In this context, I request authors to note that even if P-value(s) turn(s) out to be significant (while comparing baseline characteristics despite random allocation), it is, by definition, a false positive as you then are supposed to be testing ‘randomization’ then, which in any single trial may not balance all baseline characteristics {though I am sure that these learned authors already know these things}.

Please note that any regression techniques are not basically/originally developed for any sort of [between or within group(s)] comparison(s). Using mixed-model regression is very appropriate in given situation, but note that ‘Head-to-head’ comparison is expected, as this is an indirect/secondary/by-product testing, in my opinion.

As pointed out in ‘important note’ above “This review pertains only to ‘statistical aspects’ of the study and so ‘clinical aspects’ should be assessed separately/independently. In my opinion, to make this article acceptable (which is quite possible and easy), a small amount of re-vision (re-drafting) may be needed. ‘Minor revision’ is recommended.

Reviewer #2: The authors present a Registered Report Protocol on a randomized and controlled study on the effect of group singing on speech perception in noisy surroundings and psychosocial health in a cohort comprising 210 participants (including controls).

The research direction, the paradigms used, and the analysis presented are excellent. The authors gave a comprehensive overview in the introduction section, considering plenty of topics and references recently published and motivating their project. Also, the method section is comprehensively written and seems reproducible.

Furthermore, this study generally meets the criteria to be considered for publication in Plos One. Nevertheless, some points should be addressed before being considered for publication.

General

• Please avoid some acronyms/abbreviations, such as HA, MSB, TMCM, etc., that were only used in a particular paragraph or section. Using these abbreviations makes it hard to read the text and is not necessarily needed.

• Fig. 2 shows no additional relevant information and should be eliminated.

• I miss a paragraph on „Expected results“. The statements in l.258-265 are more general. Can you give numbers on expected outcomes?

Introduction

• l.252: Please replace MSP with MSB (but see my comment on abbreviations before)

Methods and Methods

• l. 376: hund -> Hund

• l.376: us -> used

• l.339 & l.521: Hearing loss-related inclusion criteria will be evaluated at four frequencies of 500, 1000, 2000, and 4000 Hz, but audiological assessment at 1000, 2000, 4000, and 8000 Hz. Why this discrepancy? This discrepancy is especially relevant for older patients, where hearing loss affects higher frequencies.

Data Analysis

• l.609/610: Please carefully check the syntax of Eq. (1). I suppose „min“ should be subscripted.

• l.671-673: Please avoid R-syntax. It would be more helpful to explain what will be dependent variables and which explanatory variables (and their interaction) will be considered.

Reviewer #3: This is a thorough and well-planned study regarding a promising subject.

ARHL affects large parts of the population and brings with it further serious life limitations on social, emotional and cognitive levels. Group singing as culturally anchored activity could be a simple and inexpensive method to counteract the negative consequences of ARHL, and there is already some evidence of effectiveness. However, previous studies have flaws that do not allow any watertight conclusions to be drawn. The presented study attempts to generate clarity through a large number of test subjects and control groups, the multi-site approach and extensive multi-level testing and statistics. The study meets the PLOS ONE publication criteria.

I have only a few remarks listed below.

General: Regarding the central point of the study, I would appreciate a little more detailed outline of the group singing sessions. It is totally legitimate that there can (must!) be flexibility and adjustments in the sessions’ progressions and I acknowledge that each protocol will be supplemented in the final report. However, since there are many different approaches for choir/group singing, it would be interesting to know a few conceptual details, e.g. whether there is going to be a warm-up of which duration and content or what repertoire is roughly in focus. What are the choir leaders’ qualifications/specifications?

Title: The title seems very long – is there an possibility to shorten it?

L. 31: The word „appropriate“ is somewhat undefined: Could you insert something that makes clear what it means in this context?

L. 52: „Older adults“ seems undefined. I would appreciate if you gave their actual age range, where possible, i.e., 60+

L. 61: Is there a conjunction missing before „impacts“, i.e., “and”, „which“ or „that“? Or divide it into two sentences for easier understanding.

L.100 and L. 203-204: I suggest replacing the expression “with promise” by “showing promise” or “promising”.

L.104: The item “marriage” appears standing out in this list of terms, because it is very specific while the others are rather general. I would prefer to read “ceremonies” or similar.

L.113: I suggest inserting a comma before “given”.

L.137-138: I might not understand it correctly, but what is the difference here between music and music domains?

L. 141: Please insert a comma before “and”.

L.215-216: I wonder why some nouns in this phrase are upper-case and if it makes sense in that context and sentence structure.

L.263-264: I think it is sufficient to use “detail” only once in the whole sentence for easier reading.

L.268: I wonder how “higher-level” music skills are defined?

L.376: Correctly, the German nouns Hund and Drei should be capitalized.

L.376: “we use” instead of “we us”.

L.512: I wonder if a 2-week window after training completion is too large and if effects already go missing after such time span. I do agree that the tests are time consuming and difficult to organize. Is there any rationale that the effects can be expected to last or for how long, especially after not continuing the training and not having done such a training ever before? How long do you estimate it will take to complete a single macro test?

L.552ff: Are the research assistants in choir and audio groups the same or different people? Could this be relevant regarding bias due to uneven personal engagement in one of the interventions?

L. 678-680: Please indicate what these persons are acknowledged for, i.e. what their contributions were.

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Reviewer #1: No

Reviewer #2: No

Reviewer #3: Yes: Marie Köberlein

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Speech-in-noise, psychosocial, and heart rate variability outcomes of group singing or audiobook club interventions for older adults with unaddressed hearing loss: a SingWell Project multisite, randomized controlled trial, registered report protocol

PONE-D-24-30955R1

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PLOS ONE