-->PONE-D-25-67345-->-->Assessing the Caregiver Perception of Quality of Dying and Death Questionnaire- Revised Global-Version-->-->PLOS One

Dear Dr. Tilly,

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Additional Editor Comments (if provided):

The revised version of the instrument is timely and addresses an important issue in improving the QODD questionnaire. However, there are substantive issues that undermine the strength of the claims, particularly around transparency, generalizability, and framing. The authors need to address these issues.

General Comments

Framing and scope. "Global Version is misleading. The data are drawn from two high-income, English-speaking North American countries, with a predominantly white, English-speaking caregiver sample. This is not a global study. The original problems identified in Kenya/Uganda, such as high non-response and cultural irrelevance, remain untested here. The authors should reframe the study and reserve "global" for a future multi-country, low-resource setting study. Acknowledge this limitation early in the manuscript.

Insufficient detail on instrument development. The introduction briefly describes the study team's item-by-item review and censuses but provides no detail on the specific criteria used for item removal or rewording. Was an expert panel involved? Was a Delphi process or a formal content validity index calculated? How exactly did the revisions address the document problems in low-resource settings? Without this information, readers cannot judge whether the revision represents genuine conceptual advancement or merely a cosmetic change. The authors should dedicate a subsection in the Methods to summarizing the original instrument and the revised instrument, and include a rationale for the changes to the items included and excluded.

Sampling. The sample size is n=18. Is this correct? There is a minor discrepancy between 17 and 18. While this sample size is reasonable for qualitative cognitive interviewing, it is presented as sufficient for "validation." The authors do not discuss data saturation; furthermore, recruitment was limited to caregivers who agreed to be contacted. This clearly selects for more resilient, less acutely grieving, English-speaking hospice-involved families. Inpatient hospice deaths only further limit representativeness. Were there any non-English speaking or non-White participants? The authors should justify the sample size by referencing similar cognitive interviewing studies and data saturation. Explicitly discuss selection bias and implications for content validity claims. Consider adding that future studies should test the instrument in home deaths, low-resource settings, and linguistically/culturally diverse samples.

Analysis and Interpretation of Cognitive Interview Data

Dual independent coding and consensus are a strength; however, the manuscript lacks key details. Was a codebook developed a priori or generated inductively? How was inter-rater reliability assessed? The authors noted multiple response difficulties, yet conclude that no single question was confusing and that the items are clear and relevant. This is inconsistent. A stronger conceptual model of the response process, as suggested by one reviewer, would elevate the paper. For instance, examine the information sources that lead to judgment strategies, barriers, and response issues. In addition, the authors should provide missing analysis details, temper the conclusion language, and more explicitly link the findings to COSMIN response-process validation standards. Discuss whether caregivers are truly rating the quality of dying and death.

The authors should address the following.

Clarify 17 or 18 participants (abstract states 18 cognitive interviews, yet only 17 were conducted?)

Consider mentioning any pre-interview "think-aloud" training for participants, a standard cognitive interviewing technique.

All tables and figures should stand alone or be self-explanatory

In the discussion, reduce repetition of the original items, and focus on how the revised version is improved.

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Reviewers' comments:

Reviewer's Responses to Questions

-->Comments to the Author

1. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. -->

Reviewer #1: Yes

Reviewer #2: Partly

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-->2. Has the statistical analysis been performed appropriately and rigorously? -->

Reviewer #1: Yes

Reviewer #2: No

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-->3. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). 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: No

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-->4. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.-->

Reviewer #1: Yes

Reviewer #2: No

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-->5. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)-->

Reviewer #1: 1. Is the manuscript technically sound, and do the data support the conclusions?

Abstract was well-written, easy to follow. The rationale in the introduction of the QODD-RGV was relevant and technically sound. Participants and recruitment was detailed enough to be replicated. I thought it was wise that the caregiver filled out a questionnaire regarding the patient demographics as this is important information to understand with the dying process.

Line 142: was there any pre-training done for participants? For example, asking the participant to talk aloud how many windows are in their house. This would facilitate and ensure they are comfortable thinking aloud their thought processes. It's not necessary but just curious.

Was a combination of think aloud tactics utilized with the verbal probes? Or was it just the verbal probes?

2. Has the statistical analysis been performed appropriately and rigorously?

Yes, demographics for caregivers and patients shown with appropriate descriptive information. Additionally, there is a nice table regarding the mean item ratings. Coding was well documented and there was a table regarding the participant exact wording.

3. Have the authors made all data underlying the findings in their manuscript fully available?

Yes - I originally was confused on the 1 to 10 scale, but it was explained in the footnote in table 2 which was well explained.

The content analysis coding scheme chart was very prudent to add to support the data.

4. Is the manuscript presented in an intelligible fashion and written in standard English? Yes.

5. Review Comments to the Author

Thank you for allowing me the opportunity to review this excellent manuscript. From a medical aspect and researcher perspective, the manuscript was well-written, logically organized, and any questions that arose while reading were immediately addressed, reflecting the inclusion of sufficient detail. This is very important work, and I would love to see how this scale would apply to an ICU setting.

Reviewer #2: The aim of this research addresses an important need in palliative care research. However, I do have some serious concerns as in its current state, the study would be impossible to replicate due to lack of transparency. For example, the relationship between validation phases is not clearly defined and I am confused on whether the subset was purposefully or conveniently sampled. As a qualitative researcher, a sample size of 17 is adequate for phenomenological study, but insufficient for validation. Also, what is the justification for only 17? I also see no evidence of whether data saturation was achieved. Because the sample was predominantly White and English-speaking, I don’t see how validation of a “global” instrument was achieved solely based on US/Canada. I would definitely reframe this study as a “preliminary validation in North American hospice settings.” Importantly, the sample of caregivers was comprised of only those willing to be contacted post-death (4-6 months after), which likely differ from those unwilling to be contacted, and perhaps those more acutely distressed (< 4-6 months post death), as well as those non-White, and/or non-English speaking. Since all participants were from inpatient hospice, the study excludes those who may have died at home or in some other care system, which severely limits representativeness and generalizability. Concerning the instrument itself, how were items revised? Was the Delphi method used? Was there an expert panel review? What criteria were used for item removal/modification? I also have concern with the term “quality of dying and death,” because there is no operational definition, rather it’s broadly described. More importantly, I assume that the definition of “quality” might change depending on global context and culture. I commend the authors for using a dual coding structure, and for how they describe their categorical/descriptive/content analysis, but I think a conceptual model for response process is warranted. For example, authors could easily synthesize respondents’ answers into the domains of (1) information sources (e.g., caregivers drew info. from patients “what they said/did,” caregivers “what was observed/felt,” and other family input); (2) caregiver judgment strategies (ideal vs. actual death, distress vs. no distress, pre-vs. active-dying or post-death phase, and norms about “a good death”); (3) constraints /response barriers (e.g., lack of communication with patient, irrelevant issues (e.g., religion), ambiguous timeframes, and rapid clinical changes); and (4) response issues (e.g., difficulty using Likert scales, guessing when uncertain, and collapsing multiple perspectives into one score). To me, a major question this manuscript raises (and the authors do not address) is whether respondents are actually assessing “quality of dying” or something else entirely (e.g., caregiver satisfaction)? Since two coders were used was a code book developed? I see the content analysis code schema (Table 3) but were codes identified a priori or in-vivo? What criteria did the authors use to define a code? How was inter-coder reliability assessed? Perhaps this is just me, but the whole section about the “response difficulty” is a serious concern in the manuscript. I understand this is a first step, descriptive study, but based on the issues with the instrument, I am highly skeptical of the “content validity” findings from this study. At best, this study only provides partial support for item clarity, conceptual relevance, and response process validity. I also take issue with the statement “no item was confusing” because the authors’ report multiple response difficulties. Another big issue that I have with this manuscript is that no empirical framework was mentioned for how the instrument was evaluated. Based on how the manuscript reads, I believe the authors were trying to evaluate validity using COSMIN Standards. So, why not explicitly mention it and align the paper accordingly? The limitations of the instrument are reiterated multiple times across the introduction and discussion sections (which is unnecessary) with little to no contribution to the real empirical issue (i.e., the question raised by this manuscript). To strengthen the manuscript, the authors should revise the aim of this manuscript from a descriptive validation to one that explicitly asks, “are the QODD-RGV items understandable and acceptable to caregivers?” or “How does the QODD-RGV modify, improve, or reconceptualize the measurement of QODD; particularly given the known limitations of the original instrument?” To do so, the authors must clearly demonstrate conceptual advancement of the instrument (i.e., not just revised items, but a revised understanding of the construct), show the mechanism of improvement (e.g., explain how revising the instrument solved its previously established issues), and provide empirical evidence of said improvements (e.g., not just that items are “clear,” but that they reduce ambiguity, improve response consistency, and function across diverse perspectives). This way, conceptualization of caregiver-reported QODD at end-of-life becomes interpretive rather than just observational. Then, and only then, the authors can explicitly state that this study scientifically contributes to the advancement of the instrument. The authors should also check that their data availability statement meets PLOS standards, because I don’t think that it does. I also so a typo (17 vs 18 participants).

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Reviewer #1: Yes: Kimberly Haag

Reviewer #2: No

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<p>Content validity of the Quality of Dying and Death Questionnaire- Revised Global-Version in North American inpatient hospices

PONE-D-25-67345R1

Dear Dr. Tilly,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

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Academic Editor

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Additional Editor Comments (optional):

Reviewers' comments:

Reviewer's Responses to Questions

-->Comments to the Author

1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.-->

Reviewer #1: All comments have been addressed

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-->2. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. -->

Reviewer #1: Yes

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-->3. Has the statistical analysis been performed appropriately and rigorously? -->

Reviewer #1: Yes

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-->4. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). 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

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-->5. Is the manuscript presented in an intelligible fashion and written in standard English?

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Reviewer #1: Yes

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-->6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)-->

Reviewer #1: (No Response)

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Reviewer #1: Yes: Kimberly Haag

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