Development and external validity of a nurse-led intervention program to improve palliative care and quality of dying and death in intensive care unit.

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Learn more: PMC Disclaimer | PMC Copyright Notice PLoS One . 2026 Apr 10;21(4):e0346585. doi: 10.1371/journal.pone.0346585 Search in PMC Search in PubMed View in NLM Catalog Add to search Development and external validity of a nurse-led intervention program to improve palliative care and quality of dying and death in intensive care unit Kazuaki Naya Kazuaki Naya 1 Department of Adult Health Nursing, Tokyo Healthcare University, Wakayama Faculty of Nursing, Wakayama City, Wakayama, Japan Conceptualization, Data curation, Formal analysis, Funding acquisition, Investigation, Methodology, Project administration, Resources, Software, Validation, Visualization, Writing – original draft, Writing – review & editing Find articles by Kazuaki Naya 1 , Hideaki Sakuramoto Hideaki Sakuramoto 2 Division of Faculty Development, Department of Nursing, Kindai University, Sayama, Osaka, Japan Conceptualization, Methodology, Supervision, Writing – review & editing Find articles by Hideaki Sakuramoto 2, * Editor: JONATHAN BAYUO 3 Author information Article notes Copyright and License information 1 Department of Adult Health Nursing, Tokyo Healthcare University, Wakayama Faculty of Nursing, Wakayama City, Wakayama, Japan 2 Division of Faculty Development, Department of Nursing, Kindai University, Sayama, Osaka, Japan 3 The Hong Kong Polytechnic University, HONG KONG Competing Interests: The authors have declared that no competing interests exist. ✉ * E-mail: [email protected] Roles Kazuaki Naya : Conceptualization, Data curation, Formal analysis, Funding acquisition, Investigation, Methodology, Project administration, Resources, Software, Validation, Visualization, Writing – original draft, Writing – review & editing Hideaki Sakuramoto : Conceptualization, Methodology, Supervision, Writing – review & editing JONATHAN BAYUO : Editor Received 2025 Sep 23; Accepted 2026 Mar 21; Collection date 2026. © 2026 Naya, Sakuramoto This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. PMC Copyright notice PMCID: PMC13068268  PMID: 41961844 Abstract Introduction In Japan, end-of-life care in intensive care units (ICU) remains inconsistent and often suboptimal, contributing to variability in the quality of dying and death. This study aimed to develop a culturally appropriate nurse-led intervention program to improve the quality of dying and death in Japanese ICU. Methods Using a structured framework for intervention development, we conducted a systematic and scoping review to identify modifiable factors and effective strategies for end-of-life care in ICUs. Eight evidence-based strategies were synthesized into four core components: symptom management, multidisciplinary bedside conferences, family conferences, and end-of-life care. A preliminary intervention program was developed and evaluated through expert interviews and web-based surveys to assess its clarity, feasibility, and alignment with the Japanese healthcare system. Results Based on expert feedback, revisions were made to enhance the clarity, feasibility, and alignment with the Japanese healthcare system. Key improvements included initiating symptom management early upon ICU admission, allowing flexible scheduling of conferences, and incorporating structured tools and frameworks commonly used in Japan. Additionally, a ladder-based system was introduced to tailor the intervention intensity according to the patients’ clinical conditions. Conclusion The final nurse-led intervention program was designed to facilitate more consistent delivery of end-of-life care in the ICU regardless of individual providers’ knowledge or attitudes. This study demonstrates a rigorous and culturally adapted intervention development process that may serve as a model for improving end-of-life care in ICU in Japan and other healthcare systems. Introduction The intensive care unit (ICU) is primarily designed to treat patients with critical illnesses who have the potential for recovery; however, owing to illness severity, ICU mortality remains high. In settings where life-saving interventions are prioritized, it is often difficult to create an appropriate end-of-life (EOL) environment, and adequate EOL care is not consistently provided [ 1 ]. A comparison of the Quality of Dying and Death (QODD) assessed by bereaved family proxies between ICU and hospice settings revealed that patients in the ICU have significantly lower QODD scores than those in hospice settings [ 2 ]. Notably, scores for pain control (ICU: 2.1 ± 2.1; hospice: 5.3 ± 3.1; P = 0.001) and breathing comfort (ICU: 2.1 ± 2.7; hospice: 4.1 ± 3.0; P = 0.032) were markedly lower in the ICU group than in the hospice group. The key factors associated with QODD include the presence of advanced directives, effective communication with families, and support for decision making [ 3 ]. In the ICU setting, patient prognosis at admission is often uncertain, and may change over time. Many patients who die in the ICU initially receive aggressive, life-sustaining treatments with the expectation of recovery. Therefore, discussions regarding patient values, preferences, and advance directives should be initiated early after ICU admission and revisited as clinical conditions evolve. Inadequate symptom control is a major contributor to poor QODD [ 4 ], and ICU patients frequently experience significant unrelieved physical and psychological distress [ 5 ]. Accordingly, palliative care should be provided to all ICU patients regardless of their prognosis. Although ICU palliative care initially focused on EOL care, it is now understood to encompass symptom management, shared decision-making, and support for patients and their families throughout the course of the critical illness [ 6 ]. Although various interventions have attempted to improve QODD, few have systematically integrated multiple strategies to address its complex determinants [ 7 ]. In Japan, research focusing on the EOL care for ICU patients and their families is scarce. One study reported that patients with terminal cancer in Japanese ICUs received lower-quality EOL care than those in palliative care units, citing insufficient knowledge and skills among physicians and nurses [ 8 ]. Additionally, a multicenter cross-sectional study found that the use of a high-flow nasal cannula may improve symptom relief and QODD at the EOL [ 9 ]. Despite these insights, culturally and systematically appropriate interventions for ICU EOL care remain underdeveloped in Japan. This study aimed to develop an intervention program to improve QODD in Japanese ICUs, guided by the Six Steps in Quality Intervention Development (6SQuID) framework [ 10 ] and adapted to Japan’s healthcare system and cultural context. Methods The intervention program was systematically developed based on the first four steps of the 6SQuID framework [ 10 ], as illustrated in Fig 1 . Initially, we conducted a systematic review and meta-analysis (SR/MA) [ 3 ] and a scoping review (ScR) [ 7 ]. The findings from these reviews were synthesized and applied in Steps 1–3. Step 4 involved drafting a preliminary version of the intervention program and assessing its internal and external validity. Based on the results, the program was revised and finalized. Fig 1. Process for developing a preliminary version of the intervention program. Open in a new tab The study protocol was approved by the Ethics Committee of the Japanese Red Cross Kyushu International College of Nursing (Approval No. 24−014, Approval Date: July 3, 2024). The participants were recruited between July 3 and July 11, 2024. All participants gave consent to participate before starting the focus group interviews (FGI) and Web-based surveys. Reviewing the explanatory document and submitting the consent form were regarded as provision of consent. They were also informed that their participation was voluntary and that they could withdraw at any time without penalty. Literature review of QODD in the ICU STEP 1: Define and understand the problem and its causes. A review of the existing literature revealed a clear need for both clinical and academic interventions to improve QODD in ICU settings. The underlying causes of suboptimal EOL care were analyzed to identify the key contributing factors. STEP 2: Clarify which causal or contextual factors are malleable and have the greatest scope for change. We identified the modifiable causes and contextual factors with the highest potential for impact. In cases where causal pathways were complex and interrelated, we pinpointed critical intervention points either to disrupt causal chains or apply multilevel strategies. We also assessed the changes likely to produce the greatest improvements in QODD. STEP 3: Identify how to bring about change (the change mechanism). For each modifiable factor, feasible strategies for change were examined. The mechanisms of action were clearly defined to illustrate how each intervention component contributed to the improved QODD outcomes. Developing the intervention program Developing a preliminary version of the intervention program. STEP 4: Identify how to deliver the change mechanism. A preliminary intervention program was constructed by incorporating the change mechanisms identified in Step 3. To assess validity, both internal and external evaluations were conducted through FGIs with experts and a web-based expert survey. Externally validating a preliminary version of the intervention program. (1) FGI with experts An FGI was conducted to evaluate the internal and external validity of the preliminary program. Snowball sampling was used to recruit the experts. Individuals were eligible to participate if they met the inclusion criteria (a), (b), or (c) and did not meet any of the exclusion criteria. The eligibility criteria were as follows: (a) physicians or nurses with at least five years of experience working in ICUs; (b) nurses certified in intensive care, certified nurse specialists in critical care nursing, educators, and researchers specializing in intensive care; and (c) physicians involved in palliative care or EOL care in the ICU. The exclusion criteria were as follows: (d) participants with no experience in palliative or EOL care in the ICU, (e) participants with a conflict of interest related to this study, (f) participants who were unable to provide informed consent, and (g) participants who had experienced the loss of a family member within the past six months. Since early bereavement reactions and psychological symptoms tend to be most pronounced within the first six months following loss [ 11 ], these individuals were excluded to minimize psychological distress and avoid triggering recollection of recent bereavement. Interviews were conducted remotely via videoconferencing. Audio recordings were transcribed verbatim and reviewed multiple times. Common themes were identified and synthesized. Revisions of the preliminary program were based on expert feedback. Qualitative saturation was achieved when no new themes or suggestions relevant to the refinement of the intervention program emerged during the later stages of the FGI. To ensure trustworthiness of the content analysis, the data were reviewed repeatedly by two researchers and supervised by a qualitative research expert. The raw data were rechecked to ensure accuracy. Additionally, the analyzed data were verified with the participants to ensure that their statements were accurately reflected and that no additional opinions were omitted. The revised version was defined as the “modified intervention program.” The interview guidelines are presented in Table 1 . Table 1. Interview guide. Question (1) The intervention program includes care for end-of-life patients and for others. What are your thoughts in this regard? (2) If you were to provide care according to the intervention program, are there any aspects you find challenging to implement or consider that they should be revised? (3) Suppose you were responsible for developing this program and had the authority to improve it. What would be the first thing you would change? Please focus on modifications to the existing content rather than additions. (4) Among the topics discussed today, what did you find most important? (5) Following a brief verbal summary of the interview, does the summary accurately reflect what was discussed? (6) After restating the purpose of the study, do you have any additional comments or is there anything you consider was overlooked during the interview? Open in a new tab (2) Web-based survey with experts Content validity of the modified program was assessed using a web-based expert survey. The survey items are presented in Supporting Information (see S1 Text ). The process was as follows: (a) Experts were provided with the FGI data together with the modified program and then asked to evaluate the alignment between the revisions and FGI findings. (b) Quantitative evaluation was conducted using Lynn’s method [ 12 ] and the content validity index (CVI) was calculated. Qualitative comments were also collected. (c) Items were rated on a four-point scale (4 = valid, 3 = fairly valid, 2 = somewhat lacking validity, and 1 = not valid). The item-level CVI (I-CVI) was calculated as the proportion of items with a score of three or four, with ≥0.78 set as the threshold for acceptable content validity. (d) Items with I-CVI < 0.78 were revised using qualitative feedback. This evaluation–modification cycle was repeated until all items reached I-CVI ≥ 0.78. Sample size for FGI Based on a previous study [ 13 ], we targeted a focus group of six to eight participants. Results Literature review of QODD in the ICU STEP 1: Define and understand the problem and its causes. The SR/MA results identified multiple factors associated with improved QODD in the ICU. These included the absence of cardiopulmonary resuscitation at EOL, death without the use of full life-sustaining measures, provision of a therapeutic environment, effective symptom management, and preservation of patient dignity (e.g., optimal control of physical symptoms, management of events, and maintenance of self-respect). These findings suggest that interventions aimed at promoting dignity and comfort among ICU patients may improve the quality of EOL care in this setting [ 3 ]. STEP 2: Clarify which causal or contextual factors are malleable and have greatest scope for change. The ScR identified 10 intervention strategies to improve QODD [ 7 ]. Among these, “family participation in bedside rounds” and “feedback on EOL care for healthcare workers” were excluded because of insufficient supporting evidence, thus resulting in the selection of eight strategies. A substantial gap in evidence has been noted regarding symptom management, underscoring the need to develop intervention programs that specifically target this aspect. STEP 3: Identify how to bring about change (the change mechanism). To improve QODD in the ICU, we identified eight evidence-based intervention strategies, grouped into four core components. For each strategy, we articulated the underlying mechanisms by which these changes were expected to occur. (1) Evidence-based symptom management Improving the control of distressing symptoms (e.g., pain and agitation) reduces physical suffering, thereby directly enhancing patient comfort and dignity, which are the core domains of QODD. (2) Multidisciplinary bedside conference Regular interdisciplinary communication fosters shared decision-making and early palliative care. This improves goal-concordant care and symptom management, leading to improved QODD. (3) Family conference Early and structured family meetings support informed surrogate decision making, thus reducing unnecessary invasive treatments, and increasing family satisfaction. These are correlated with an improved QODD. (4) EOL care Emotional support and honoring patient/family wishes during the dying process reduce treatment intensity, align care with values, and preserve dignity, thus leading to improved QODD. Developing the intervention program Developing a preliminary version of the intervention program. STEP 4: Identify how to deliver the change mechanism. Based on these eight intervention strategies, we developed a preliminary nurse-led intervention program to improve palliative care and QODD in ICU. Rather than following a ladder-based approach, the intervention was designed with a time- and condition-dependent flow of care. Patients were screened based on their clinical status over time and subsequent steps in the intervention proceeded according to this screening, creating a structured flow throughout the ICU stay. A flow diagram was developed to visually guide the practice. Given the complexity of transitioning from curative to EOL care in modern ICUs, it was necessary to identify appropriate patients at an early stage, rather than focusing only on those who are near death. Therefore, primary screening criteria were established to identify eligible patients from among all ICU admissions. Once identified, evidence-based symptom management was initiated on ICU admission. For these patients, multidisciplinary bedside conferences were held within 24 h to clarify the goals of care and discuss treatment strategies. This step enabled the early planning of family conferences and timely initiation of EOL care. Nurses closely involved in daily patient care serve as key agents of the program. Their roles in symptom assessment, patient identification, and coordination of multidisciplinary meetings were explicitly defined and formally integrated into the intervention procedures. The intervention program was compiled into a booklet including an intervention flow diagram and designed for distribution to the departments participating in the intervention. Externally validating a preliminary version of the intervention program Six experts conducted the FGI and web surveys. Based on the FGI results, the preliminary program was modified, and the validity of these modifications was assessed through a web survey. The experts included two physicians and four nurses, all of whom were clinical nurses in the ICU as well as educators and researchers in palliative care and symptom management ( Table 2 ). Table 2. Characteristics of the participants. Variable n (%) Male 4 (66.7) Physicians involved in palliative care or EOL care in the ICU 2 (33.3) Educator and researcher specializing in palliative care in the ICU 1 (16.7) Educators and researchers specializing in symptom management in the ICU 1 (16.7) Critical certified nurse specialist 2 (33.3) Open in a new tab EOL, end-of-life; ICU, intensive care unit Validation by FGI for experts The expert feedback was categorized into the following areas: scope and selection of target populations for the intervention program ( Table 3 ), strategies to enhance the feasibility of the intervention, incorporation of evidence from Japan, and refinement of terminology and wording ( Table 4 ). Table 3. Expert Opinions on the Target Population of the Intervention Program. Topic Expert opinions Main revisions Care Recipients Under the Intervention Program Scope of the Target Population Including patients who are not in the terminal stage in a program designed to improve the quality of dying and death was considered inappropriate. The program content was restructured into a tiered format, with symptom management integrated at each level. As determining when ICU patients transition to the terminal stage is challenging, non-terminal patients remain included. Symptom management should be provided to all patients, not only those in the terminal stage; therefore, non-terminal patients should be included. Selection of the Target Population The initial screening criteria are appropriate because they enable the identification of severely ill patients. The intervention program flowchart was revised to a tiered format, and a process was added at the initial screening stage for transitioning to end-of-life care. A process may be needed during the initial screening stage to determine whether end-of-life care is appropriate. The item “4. Patients who are not native Japanese speakers” may be unnecessary in the screening process. (3) The item regarding non-native Japanese speakers was removed from the screening criteria and incorporated into “Basic Information Related to the Quality of End-of-Life Care.” Open in a new tab ICU, intensive care unit Table 4. Expert opinions and revisions on the feasibility of the intervention program. Program components Topic Expert opinions Main revisions Provision of Evidence-based Symptom Management Methods (Timing, Participants, Procedures, etc.) Prompt initiation of symptom management upon ICU admission is essential. “Evidence-based Symptom Management” was revised to begin based on the results of the initial screening conducted upon admission. Is the frequency of the “Symptom Management and Palliative Care Conference” appropriate? It should be conducted daily. The conference frequency was revised from once every 3 days to daily, and a note was added stating it can be integrated into existing rounds and conferences. Given current drug use practices in Japanese ICUs, “morphine” should be replaced with “opioids” for pain management, as fentanyl is often preferred. References to “morphine” and “fentanyl” were consolidated under the term “opioids.” Use of Japanese Evidence Some listed assessment tools (e.g., the Japanese version of the RDOS) are not widely used in Japan; should alternatives be allowed? The listed assessment tools are examples; other tools may be used. The ICDSC was added alongside the CAM-ICU as a delirium assessment tool. The contents of Japan’s clinical practice guidelines for dry mouth can serve as a reference. ROAG and OAG were included based on Japanese clinical guidelines. Revisions to Wording As this is a nurse-led program, it would be better to revise the sentence subjects to refer to nurses. Sentence subjects were revised to refer to nurses.(For example: “Suggest … to the attending physician,” etc.) Multidisciplinary Bedside Conferences Methods (Timing, Participants, Procedures, etc.) Holding the initial conference within 24 h of ICU admission is difficult for attending physicians. The intervention program flowchart was revised into a tiered format (Tiers I–III), limiting the target population for interprofessional bedside conferences to Tier II and above. The timing of the initial conference was extended from “within 24 h of ICU admission” to “within 3 days of starting Tier II” to allow for greater flexibility. An addition was made to clarify that existing rounds and conferences may serve as substitutes for this conference. It is challenging for attending physicians to participate in the conferences while in open ICUs. ICU physicians cannot independently set treatment goals without the attending physician’s presence. In facilities already conducting conferences, how would this conference be differentiated? The content should be simplified using a framework such as Jonsen’s four-box method. The content of the conference was structured according to Jonsen’s four-box method. To support regular implementation, the content was simplified through the use of a structured framework. Given the current shortage of interprofessional conferences, the content should be structured to support regular implementation. Family Conference Methods (Timing, Participants, Procedures, etc.) Conducting family conferences at the designated times can be challenging. A revision was made to assess the need for family meetings during the interprofessional bedside conferences and to conduct them as early as possible. Who should participate in the family meetings? Participant information was added. A pre-meeting should be held before the family meeting to ensure alignment among healthcare providers. An addition was made stating that the interprofessional bedside conference, which determines the need for a family meeting, also functions as a pre-meeting. Healthcare providers may require training in conducting family conferences. Communication guides were added to support staff training. Revisions to Wording The phrase “the patient’s values regarding life and death” may be too specific and difficult for the families to address. It may be preferable to use the broader term “the patient’s values.” The phrase “the patient’s values regarding life and death” was revised to “the patient’s values.” Specific topics to be discussed during the meeting were outlined. It may be more appropriate to refer to it as a family meeting rather than a family conference. The terminology was revised from “family conference” to “family meeting.” End-of-Life Care Methods (Timing, Participants, Procedures, etc.) Clear specification is necessary regarding who should provide the care and when. The purpose, timing, and providers of end-of-life care were added. The example information provided needs to be revised to reflect ICU patients. The example information regarding the condition of patients near the end-of-life was revised to better reflect ICU patients. It may be beneficial to include information regarding the removal of unnecessary lines, the easing of visitation restrictions, and the potential transfer to a general ward. Information was added regarding the removal of unnecessary lines, the easing of visitation restrictions, and the potential transfer to a general ward. Use of Japanese Evidence It may be advisable to include information on grief care and psychological support for families, referencing the “Practice Guide for End-of-Life Nursing in Emergency and Critical Care.” Content addressing care before and after bereavement was added, referencing the “Practice Guide for End-of-Life Nursing in Emergency and Critical Care.” Open in a new tab ICU, intensive care unit; RDOS, Respiratory Distress Observation Scale; ICDSC, Intensive Care Delirium Screening Checklist; CAM-ICU, Confusion Assessment Method for the Intensive Care Unit; ROAG, Revised Oral Assessment Guide; OAG, Oral Assessment Guide. (a) Scope and selection of target populations for the intervention program Regarding the selection of target populations for the intervention program, some experts expressed concern about the inclusion of patients with non-terminal illnesses and noted a potential inconsistency with the program’s stated aim of improving the QODD. They highlighted that, “Including patients who are not in the terminal stage in a program designed to improve the quality of dying and death was considered inappropriate.” Conversely, there was a consensus on the importance of including patients outside the terminal phase, particularly because the core symptom management component of the intervention program should be provided to all patients in the ICU, and not only to those who are terminally ill. In essence, “Symptom management should be provided to all patients, not only those in the terminal stage; therefore, non-terminal patients should be included.” Regarding patient selection, it was proposed that a primary screening item should be used at the time of ICU admission to identify critically ill patients who may benefit from an intervention program. However, some experts noted the absence of a clear process for determining the transition to EOL care during this initial screening: “The initial screening criteria are appropriate because they enable the identification of severely ill patients. A process may be needed during the initial screening stage to determine whether end-of-life care is appropriate.” The primary screening items were revised in response to these comments, and the intervention process, which originally followed a time- and condition-based flow, was reorganized into a stepwise ladder-like format ( Fig 2 ). This allowed for the initiation of symptom management from the time of ICU admission without altering the overall target population specified in the intervention program. Fig 2. Quality improvement ladder for palliative care and quality of dying and death in the ICU. Open in a new tab Following this reorganization, explicit operational criteria were defined for transitions between ladder levels ( Fig. 2 ). Ladder I was initiated for patients who required, or were highly likely to require, mechanical ventilation for more than 48 hours, or who were admitted emergently from a general ward. The transition from Ladder I to Ladder II was considered when the patient’s condition deteriorated or the response to treatment was judged to be poor. Nurses conducted this assessment during daily symptom management conferences. The transition from Ladder II to Ladder III was determined when life-saving treatment was judged difficult and the likelihood of death was extremely high. This decision was made by the nurses during multidisciplinary bedside conferences. In cases of rapid clinical deterioration or an extremely poor response to treatment, a direct transition from Ladder I to Ladder III was permitted. All screening and transition decisions were nurse-led and reassessed based on changes in the patient’s clinical condition. (b) Strategies to enhance the feasibility of the intervention and incorporation of evidence in Japan Feedback was provided on “evidence-based symptom management,” “multidisciplinary bedside conferences,” “family conferences,” and “EOL care” in relation to strategies for enhancing the feasibility of the intervention, the incorporation of evidence from Japan, and the refinement of terminology and wording. Evidence-based symptom management Regarding symptom management, the importance of initiating daily symptom management early in the ICU stay was emphasized: “Prompt initiation of symptom management upon ICU admission is essential. Is the frequency of the “Symptom Management and Palliative Care Conference” appropriate? It should be conducted daily.” In response, the post-screening flowchart was revised to ensure that symptom management was initiated early during ICU admission. To enable daily symptom management conferences, they were permitted to be incorporated into the existing rounds and meetings. Furthermore, the tools for objective symptom assessment were revised to increase versatility by including instruments that are more commonly used in Japan and avoiding restrictions on the choice of tools. “Some listed assessment tools (e.g., the Japanese version of the Respiratory Distress Observation Scale) are not widely used in Japan; should alternatives be allowed? The contents of Japan’s clinical practice guidelines for dry mouth can serve as a reference.” Multidisciplinary bedside conference Owing to variations in ICU systems across facilities (e.g., open ICUs, closed ICUs), some experts noted the challenges related to physician participation in conferences and the difficulty of holding such meetings in a timely manner: “Holding the initial conference within 24 h of ICU admission is difficult for attending physicians. It is challenging for attending physicians to participate in the conferences while in open ICUs. ICU physicians cannot independently set treatment goals without the attending physician’s presence.” In response to these concerns, the target population for multidisciplinary bedside conferences was revised from “all patients” to “patients at Ladder II or above.” Additionally, the timing of the first conference was modified from “within 24 hours of ICU admission” to “within 3 days of the start of Ladder II,” thus allowing for greater flexibility and improving feasibility. To standardize the content of multidisciplinary conferences and enhance their feasibility, Jonsen’s four-topic approach, which is commonly used in Japan, was adopted as the framework. This modification reflected expert feedback, including the following: “The content should be simplified using a framework such as Jonsen’s four-box method. Given the current shortage of interprofessional conferences, the content should be structured to support regular implementation.” Family conference Challenges regarding the feasibility of a fixed schedule were identified: “Conducting family conferences at the designated times can be challenging.” Therefore, the need for a family conference was assessed during the multidisciplinary bedside conference, and the timing was adjusted to “as soon as possible, after the multidisciplinary bedside conference determines that a family conference is necessary,” to allow for greater flexibility in implementation. In addition, the need for education for health care providers regarding communication skills in preparation for holding conferences with families was noted: “Healthcare providers may require training in conducting family conferences.” Therefore, a guide for communicating with patients and their families was added as a supplementary document. EOL care In response to expert feedback, the purpose, timing, and responsible providers of EOL care were specified to ensure that interventions are conducted at the appropriate time (i.e., “who will do it and when?”). Additionally, in response to feedback regarding the need to adjust the treatment environment, the EOL care section was revised to include the relaxation of visitation restrictions and consideration of transfer to a general ward. “It may be beneficial to include information regarding the removal of unnecessary lines, the easing of visitation restrictions, and the potential transfer to a general ward.” For family grief care and emotional support, content was added based on the Practice Guide for End-of-Life Nursing in Emergency and Intensive Care , which was developed by the Japanese Society of Critical Care Nursing in 2019. “It may be advisable to include information on grief care and psychological support for families, referencing the Practice Guide for End-of-Life Nursing in Emergency and Critical Care .” Validation via a web-based survey of experts Following the FGI, the preliminary program was revised and validated using a web-based survey involving the same six experts. The survey was designed to obtain both quantitative assessments of the revised items and qualitative feedback on the proposed modifications. All modified items achieved an I-CVI of 0.78 or higher, thereby confirming their content validity ( Table 5 ). Detailed item-level CVI ratings for each expert are provided in Supporting Information (see S2 Text ). Table 5. Validation of modifications by experts. Program components Revision items I-CVI Care Recipients Under the Intervention Program The program content was restructured into a tiered forma 0.83 Revised on “Initial screening items” and “Basic Information Related to the Quality of End-of-Life Care.” 0.83 Provision of evidence-based symptom management Methods (Timing, Participants, Procedures, etc.) 1.00 Use of Japanese Evidence 1.00 Revisions to Wording 1.00 Multidisciplinary Bedside Conferences Methods (Timing, Participants, Procedures, etc.) 1.00 Use of Japanese Evidence 0.83 Family Conference Methods (Timing, Participants, Procedures, etc.) 1.00 Revisions to Wording 0.83 End-of-Life Care Methods (Timing, Participants, Procedures, etc.) 0.83 Use of Japanese Evidence 1.00 Open in a new tab Based on the FGI results, the intervention ladder was categorized into Stages I–III. A process was initially established to transition from Ladder I or II to “Ladder III: End-of-Life Care” when the criterion “The patient or surrogate decision-maker has requested the withholding of treatment” was met. However, in response to qualitative feedback from the experts, this additional criterion was removed. Experts noted that “withholding” includes both the withholding and withdrawal of treatment, and that such decisions do not necessarily reflect an EOL situation.Consequently, the screening criterion for transitioning to Ladder III was simplified to a single item: “Difficult to save and very likely to die.” Further expert feedback highlighted that the term “surrogate decision-maker” is not legally defined in Japan, and that a “key person” does not necessarily equate to a surrogate decision-maker. In this context, it was noted that a surrogate decision-maker may not be a single designated individual but could instead comprise multiple individuals or families. In addition, the description of advanced directives was revised to include both oral and written forms rather than limiting them to written documentation. The finalized Nurse-Led Intervention Program to Improve Palliative Care and Quality of Dying and Death in the Intensive Care Unit is presented in S3 Text , and the screening and conference items are provided in S4 Text . Discussion This study utilized existing evidence identified through SR/MA and ScR to develop a nurse-led intervention program to improve palliative care and QODD in the ICU. Given the lack of interventions targeting symptom management [ 3 , 7 ] despite its recognized importance in improving QODD in ICU patients, a provisional intervention program was initially developed with a focus on symptom management. This provisional program underwent internal and external validation through FGI with experts, resulting in a revised version that aligned with the feedback obtained. The FGI emphasized the importance of initiating symptom management as early as possible after ICU admission in Japan. Furthermore, the timing, methods, and participants involved in multidisciplinary bedside and family conferences were adjusted to enhance the feasibility of the program for the Japanese healthcare system. The program was structured in a ladder format to ensure timely and appropriate delivery of care to target patients. Additional components were incorporated, including the preparation of a therapeutic environment for patients near EOL and consideration of transfer to a general ward for bereavement care. The validity of the revised program was assessed via a web-based expert survey, to confirm if the content validity for all revised items was I-CVI ≥ 0.78. The intervention program was developed through a scientifically rigorous process in accordance with the 6SQuID framework. This approach enables the adaptation and development of evidence-based intervention programs in countries with different cultural contexts and healthcare systems. Symptom management in the ICU remains suboptimal. An intervention program designed to facilitate consistent care delivery, independent of the providers’ knowledge or attitudes, may enhance symptom management. Patients in the ICU frequently experience unrelieved distress symptoms [ 5 ], which are associated with lower QODD [ 3 ]. The conflation of “palliative care” and “EOL care” [ 14 ] may contribute to the underutilization of symptom palliation in ICUs. A previous intervention to improve ICU palliative care based on the self-efficacy theory did not significantly improve QODD or pain assessment [ 15 ], despite aiming to change intensivists’ knowledge and behavior [ 16 ]. In contrast, the present program uses a structured booklet detailing the care content and implementation methods tailored to patients’ conditions. This system-based approach promotes consistent practice regardless of individual self-efficacy or behavioral changes, thus potentially improving ICU symptom management and EOL care quality. A system that facilitates effective communication between healthcare professionals and family members is essential to improve the quality of palliative and EOL care in the ICU. However, in the Japanese healthcare system, communication through bedside conferences and family meetings may not be adequately implemented without structured interventions. Closed ICU systems, which are common internationally [ 17 ], have demonstrated improved interprofessional communication [ 18 ] and outcomes [ 19 , 20 ]. In contrast, Japan has a higher prevalence of open ICUs (65.6% versus 17.1% internationally) [ 21 ], thus reflecting its ICU admission patterns [ 22 ]. Our findings highlight the challenges of conducting timely multidisciplinary meetings involving physicians. To address this issue, a ladder-based program was designed with clear criteria and care content for each stage to facilitate timely interventions and role-sharing, even in open ICU systems. The ladder approach presents staged interventions that are aligned with the patient’s condition and decision-making phase. Thus, it enables the delivery of appropriate care at the right time, even with limited human resources [ 23 ]. Expert feedback also prompted a more flexible scheduling of meetings, which was expected to improve feasibility and staff participation. The care environment during bereavement influences the quality of EOL care This program includes components to improve bereavement settings, such as easing visitation restrictions and enabling transfers to general wards. A previous study on preferred death [ 24 ] identified eight key elements, including “dying in a favorite place” and “attending the deathbed,” thus underscoring the importance of setting and family presence. The ICU-QODD also highlighted family presence [ 25 ], thus affirming the need to optimize visitation policies. Although home-based EOL care for ICU patients has been reported [ 26 , 27 ], these reports are limited to Japan [ 28 ]. Owing to the challenges in discharging critically ill patients and the limitations in the healthcare infrastructure, home care was not included in the standardized program. Given that preferences for home-based care are shaped by patients’ wishes, cultural norms, and systemic constraints, further studies are warranted. Strengths and limitations This intervention program was developed using scientifically rigorous methodology and was adapted to the Japanese healthcare system and cultural context. However, this study has some limitations. First, most of the literature on program development originates outside Japan, with limited domestic evidence. The program was modified using expert FGIs to align it with the Japanese context. Second, the patients and their families were not included as stakeholders in the development process. Nevertheless, given that the intervention was designed for the ICU setting, and revisions were based on input from nurses and physicians who play central roles, the program’s feasibility and acceptability may have been enhanced [ 29 ]. Future research should assess these aspects through studies involving patients and their families. Finally, the program’s effectiveness was not evaluated. Further implementation studies are required to examine the feasibility, acceptability, and impact of this program. Conclusion We developed a nurse-led intervention program to improve palliative care and QODD in ICUs following the 6SQuID framework. The program centers on symptom management and includes three additional core components: multidisciplinary bedside conferences, family conferences, and structured end-of-life care. The content and external validity of the program were established through a literature review and input from an expert panel. Therefore, this program has potential utility in enhancing the quality of palliative and EOL care in Japanese ICUs. Furthermore, by adhering to a scientifically rigorous developmental process, this approach offers a model for adapting evidence-based interventions to diverse cultural and healthcare contexts beyond Japan. Supporting information S1 Text. Survey instrument used for content validity indexes evaluation. (DOCX) pone.0346585.s001.docx (23.1KB, docx) S2 Text. Item-level content validity indexes ratings. (DOCX) pone.0346585.s002.docx (21.6KB, docx) S3 Text. Nurse-led intervention program to improve the palliative care and quality of dying and death in intensive care unit. (DOCX) pone.0346585.s003.docx (2MB, docx) S4 Text. Screening and conference items. (DOCX) pone.0346585.s004.docx (1.4MB, docx) Acknowledgments We thank the expert panel members for their support and cooperation in the development of the intervention program. We acknowledge Editage ( www.editage.com ) for assistance with English language editing. Data Availability All relevant data are within the manuscript and its Supporting Information files. Funding Statement This study was supported by a Grant-in-Aid for Scientific Research (C) from the Japan Society for the Promotion of Science (Grant number 25K13875). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. References 1. Tanaka Y, Masukawa K, Sakuramoto H, Kato A, Ishigami Y, Tatsuno J, et al. Development of quality indicators for palliative care in intensive care units and pilot testing them via electronic medical record review. 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A new framework for developing and evaluating complex interventions: update of medical research council guidance. BMJ. 2021;374:n2061. doi: 10.1136/bmj.n2061 [ DOI ] [ PMC free article ] [ PubMed ] [ Google Scholar ] PLoS One. doi: 10.1371/journal.pone.0346585.r001 Decision Letter 0 JONATHAN BAYUO JONATHAN BAYUO Academic Editor Find articles by JONATHAN BAYUO Author information Copyright and License information Roles JONATHAN BAYUO : Academic Editor © 2026 JONATHAN BAYUOJONATHAN BAYUOJONATHAN BAYUOJONATHAN BAYUO This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited., which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited., which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited., which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. 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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 ********** 4. Is the manuscript presented in an intelligible fashion and written in standard English??> Reviewer #1: Yes Reviewer #2: Yes ********** Reviewer #1: Dear Author, Congratulations for your great contribution to improvement of quality nursing care in palliative care. General comments: The article presents an important contribution to the care of patients under palliative care in the ICU. The manuscript is well structured and described. However, there are some areas that require further description and clarification. Abstract: please give a short background of the study and use paragraph to make it more organized. Introduction: You have provided the background of your study and identified the gap in previous studies in the similar field Methods: Did you yourself conducted both the scoping review, and systematic review and meta analysis? Step 4, Can you explain the intervention program in detail? Line 119: why did you exclude the participant who had experienced the loss of a family member within the next past 6 months? Results: Great! you have clearly explained the details you undertook in each step. Discussion: well written Conclusion: Please restate the main aspects of the intervention program Reviewer #2: The manuscript is technically sound. It clearly and coherently describes a systematic process for developing a complex intervention based on the 6SQuID framework. The steps of problem identification, systematic review, exploratory review, program development, and expert validation are well documented. The data presented (citations, tables, qualitative descriptions) adequately support the conclusions regarding the content validity and cultural relevance of the program. The methodology is coherent and consistent with the objectives. The design is framed within content development and validation; the use of the Content Validity Index (CVI) is appropriate, correctly calculated, and reported. The methodology follows classic recommendations (Lynn, 1986), using a threshold of ≥0.78 to accept items validated by experts. No additional inferential statistics are required for this type of study; the analysis is sufficient and rigorous for the stated objectives. The authors declare that all relevant data are included in the manuscript and supplementary files, which adequately complies with the PLOS data policy. The information provided is consistent with the expected elements for qualitative and methodological development studies. The manuscript is well-written, with clear and structured language. There are some minor writing and flow details that could be corrected (e.g., redundancies, long sentences), but none affect overall comprehension. The quality of the English is adequate for publication, although a final light revision is recommended. Strengths of the manuscript: 1. The study uses a recognized framework (6SQuID) that provides methodological rigor. 2. The integration of prior evidence (SR/MA and Scoping Review) and expert validation is well achieved. 3. The culturally adapted approach for the Japanese context is a significant contribution to the literature on palliative care in the ICU. 4. The ladder structure of the program is logical, clear, and potentially applicable in different clinical settings. Areas for Improvement 1. Clarity in the transition between ladder levels: Although adjusted based on expert feedback, it would be helpful to explain in more detail the operational criteria for moving between levels, especially between Ladder II and Ladder III. 2. Stronger justification for the inclusion of non-terminal patients: While explained in the discussion, reinforcing this point in the introduction would help avoid misinterpretations about the scope of the program. 3. Describe how qualitative saturation was managed in the FGI phase, given that six experts participated. This is not essential but would increase methodological transparency. 4. English fluency: Some paragraphs could benefit from grammatical simplification, especially in the Methods section. This does not affect comprehension but could increase clarity for international audiences. Overall Review Conclusion The manuscript is robust, rigorous, and provides a relevant intervention program for critical care settings, with the potential to be replicated in other cultural contexts. I recommend publishing it after addressing the minor formatting issues. ********** what does this mean? ). If published, this will include your full peer review and any attached files.). If published, this will include your full peer review and any attached files.). If published, this will include your full peer review and any attached files.). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our For information about this choice, including consent withdrawal, please see our For information about this choice, including consent withdrawal, please see our For information about this choice, including consent withdrawal, please see our Privacy Policy ..--> Reviewer #1: Yes: Mira Adhikari BaralMira Adhikari BaralMira Adhikari BaralMira Adhikari Baral Reviewer #2: No ********** [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.] To ensure your figures meet our technical requirements, please review our figure guidelines: https://journals.plos.org/plosone/s/figures You may also use PLOS’s free figure tool, NAAS, to help you prepare publication quality figures: https://journals.plos.org/plosone/s/figures#loc-tools-for-figure-preparation. NAAS will assess whether your figures meet our technical requirements by comparing each figure against our figure specifications. PLoS One. 2026 Apr 10;21(4):e0346585. doi: 10.1371/journal.pone.0346585.r002 Author response to Decision Letter 1 Article notes Copyright and License information Collection date 2026. PMC Copyright notice 19 Jan 2026 Dear Dr. JONATHAN BAYUO Thank you the opportunity to revise and resubmit our manuscript, “Development and external validity of a nurse-led intervention program to improve palliative care and quality of dying and death in intensive care unit,” to PLOS One. We sincerely appreciate the editor’s handling of our submission and the reviewers’ careful and constructive evaluations, which have been invaluable in strengthening the manuscript. In response to the reviewers’ comments, we have revised the manuscript accordingly and provide a detailed, point-by-point response below outlining how each concern was addressed. We believe that these revisions have substantially improved the clarity, rigor, and transparency of the work, and we respectfully resubmit the manuscript for your further consideration. Reviewer #1: Comment 1. Abstract: please give a short background of the study and use paragraph to make it more organized. Response: To address this, we have revised the Abstract to include a brief background of the study and reorganized it into clearly defined paragraphs corresponding to the Introduction, Methods, Results, and Conclusion sections to improve clarity and readability. Comment 2. Introduction: You have provided the background of your study and identified the gap in previous studies in the similar field Response: We appreciate the reviewer’s recognition that the introduction adequately provides the background of the study and clearly identifies the research gaps in previous studies. Comment 3. Methods: Did you yourself conducted both the scoping review, and systematic review and meta analysis? Response: Yes, we conducted the scoping review, systematic review, and meta-analysis; however, this was not clearly stated in the original manuscript. We have revised the Methods section to clarify this point and added relevant references. Page 4, line 87-91: Initially, we conducted a systematic review and meta-analysis (SR/MA) [3] and a scoping review (ScR) [7]. The findings from these reviews were synthesized and applied in Steps 1–3. Step 4 involved drafting a preliminary version of the intervention program and assessing its internal and external validity. Based on the results, the program was revised and finalized. Comment 4. Step 4, Can you explain the intervention program in detail? Response: To address the comment, in the revised manuscript, we have provided a detailed description of the intervention program, including both the original version and revisions made based on expert feedback. Initially, the program was designed as a time- and condition-based flow, reflecting the clinical trajectories of critically ill patients in the ICU. Following expert feedback, we reorganized the intervention into a stepwise ladder-like format to clarify the operational criteria for transitions between levels and to provide a more structured guide for clinical practice. We have added a description of the original flow-based program, the rationale for the reorganization, and details of each ladder level (I–III) to the Methods section. This allows readers to understand both the original program and the modifications made to enhance clarity, feasibility, and applicability in the ICU setting. Page 11, line 205-222: Based on these eight intervention strategies, we developed a preliminary nurse-led intervention program to improve palliative care and QODD in ICU. Rather than following a ladder-based approach, the intervention was designed with a time- and condition-dependent flow of care. Patients were screened based on their clinical status over time and subsequent steps in the intervention proceeded according to this screening, creating a structured flow throughout the ICU stay. A flow diagram was developed to visually guide the practice. Given the complexity of transitioning from curative to EOL care in modern ICUs, it is necessary to identify appropriate patients at an early stage, rather than focusing only on those who are near death. Therefore, primary screening criteria were established to identify eligible patients from among all ICU admissions. Once identified, evidence-based symptom management was initiated on ICU admission. For these patients, multidisciplinary bedside conferences were held within 24 h to clarify the goals of care and discuss treatment strategies. This step enabled the early planning of family conferences and timely initiation of EOL care. Nurses closely involved in daily patient care serve as key agents of the program. Their roles in symptom assessment, patient identification, and coordination of multidisciplinary meetings were explicitly defined and formally integrated into the intervention procedures. The intervention program was compiled into a booklet including an intervention flow diagram and designed for distribution to the departments participating in the intervention. Page 20-21, line 272-287: The primary screening items were revised in response to these comments, and the intervention process, which originally followed a time- and condition-based flow, was reorganized into a stepwise ladder-like format (Fig. 2). This allowed for the initiation of symptom management from the time of ICU admission without altering the overall target population specified in the intervention program. Following this reorganization, explicit operational criteria were defined for transitions between ladder levels (Fig. 2). Ladder I was initiated for patients who required, or were highly likely to require, mechanical ventilation for more than 48 hours, or who were admitted emergently from a general ward. The transition from Ladder I to Ladder II was considered when the patient’s condition deteriorated or the response to treatment was judged to be poor. Nurses conducted this assessment during daily symptom management conferences. The transition from Ladder II to Ladder III was determined when life-saving treatment was judged difficult and the likelihood of death was extremely high. This decision was made by the nurses during multidisciplinary bedside conferences. In cases of rapid clinical deterioration or an extremely poor response to treatment, a direct transition from Ladder I to Ladder III was permitted. All screening and transition decisions were nurse-led and reassessed based on changes in the patient’s clinical condition. Comment 5. Line 119: why did you exclude the participant who had experienced the loss of a family member within the past 6 months? Response: Individuals within six months of bereavement were excluded because early grief reactions and psychological distress are generally the most pronounced during this period. Because this intervention program focuses on improving the quality of dying and death, participation can evoke memories of recent losses and potentially exacerbate psychological distress. Therefore, to minimize the emotional burden and ethical risk to the participants, individuals who had experienced the loss of a family member within the past six months were excluded. Page 6, line 133-137: (g) participants who had experienced the loss of a family member within the past six months. Since early bereavement reactions and psychological symptoms tend to be most pronounced within the first six months following loss [11], these individuals were excluded to minimize psychological distress and avoid triggering recollection of recent bereavement. Comment 6. Results: Great! you have clearly explained the details you undertook in each step. Discussion: well written Response: Thank you very much for your positive and encouraging comments. They were very encouraging and motivating for our research team. Comment 7. Conclusion: Please restate the main aspects of the intervention program Response: To address this, we have revised the conclusion to clearly restate the main aspects of the intervention program. Specifically, we have added a description that the program consists of symptom management as its core component, along with three additional key elements. Page 29, line 445-452: We developed a nurse-led intervention program to improve palliative care and QODD in ICUs following the 6SQuID framework. The program centers on symptom management and includes three additional core components: multidisciplinary bedside conferences, family conferences, and structured end-of-life care. The content and external validity of the program were established through a literature review and input from an expert panel. Therefore, this program has potential utility in enhancing the quality of palliative and EOL care in Japanese ICUs. Furthermore, by adhering to a scientifically rigorous developmental process, this approach offers a model for adapting evidence-based interventions to diverse cultural and healthcare contexts beyond Japan. Reviewer #2: Comment 1. Clarity in the transition between ladder levels: Although adjusted based on expert feedback, it would be helpful to explain in more detail the operational criteria for moving between levels, especially between Ladder II and Ladder III. Response: We have added detailed explanations regarding the operational criteria for transitions between ladder levels in the Results section. Specifically, we describe the clinical conditions and decision criteria for transitions from Ladder I to II, from Ladder II to III, and from Ladder I directly to III. In addition, we clarified who performed the assessment and at what times. These explanations are consistent with the information presented in Figure 2. Page 20-21, line 277-287: Following this reorganization, explicit operational criteria were defined for transitions between ladder levels (Fig. 2). Ladder I was initiated for patients who required, or were highly likely to require, mechanical ventilation for more than 48 hours, or who were admitted emergently from a general ward. The transition from Ladder I to Ladder II was considered when the patient’s condition deteriorated or the response to treatment was judged to be poor. Nurses conducted this assessment during daily symptom management conferences. The transition from Ladder II to Ladder III was determined when life-saving treatment was judged difficult and the likelihood of death was extremely high. This decision was made by the nurses during multidisciplinary bedside conferences. In cases of rapid clinical deterioration or an extremely poor response to treatment, a direct transition from Ladder I to Ladder III was permitted. All screening and transition decisions were nurse-led and reassessed based on changes in the patient’s clinical condition. Comment 2. Stronger justification for the inclusion of non-terminal patients: While explained in the discussion, reinforcing this point in the introduction would help avoid misinterpretations about the scope of the program. Response: To address this, we have reinforced the rationale for including non-terminal patients in the intervention program by adding an explanation to the background section to clarify the scope of the program. Page 3, line 63-72: In the ICU setting, patient prognosis is often uncertain at admission and may change over time. Many patients who die in the ICU initially receive aggressive, life-sustaining treatments with the expectation of recovery. Therefore, discussions regarding patient values, preferences, and advance directives should be initiated early after ICU admission and revisited as clinical conditions evolve. Inadequate symptom control is a major contributor to poor QODD [4], and ICU patients frequently experience significant unrelieved physical and psychological distress [5]. Accordingly, palliative care should be provided to all ICU patients regardless of their prognosis. Although ICU palliative care initially focused on EOL care, it is now understood to encompass symptom management, shared decision-making, and support for patients and their families throughout the course of the critical illness [6]. Comment 3. Describe how qualitative saturation was managed in the FGI phase, given that six experts participated. This is not essential but would increase methodological transparency. Response: Although qualitative saturation was not a predefined endpoint for the FGI, it was considered achieved when no new themes or suggestions relevant to refining the intervention program emerged during the later stages of the discussion. The six experts had diverse professional backgrounds relevant to ICU palliative and end-of-life care and their feedback converged on similar key issues, suggesting sufficient information redundancy. In addition, we verified the analysis results with the participants to ensure that their statements were accurately reflected and that no additional opinions were omitted. We have clarified this in the manuscript: Page 6, line 138-147: Interviews were conducted remotely via video conferencing. Audio recordings were transcribed verbatim and reviewed multiple times. Common themes were identified and synthesized. Revisions of the preliminary program were based on expert feedback. Qualitative saturation was achieved when no new themes or suggestions relevant to the refinement of the intervention program emerged during the later stages of the FGI. To ensure trustworthiness of the content analysis, the data were reviewed repeatedly by two researchers and supervised by a qualitative research expert. The raw data were re-examined to ensure accuracy. Additionally, the analyzed data were re-examined and verified with the participants to ensure that their statements were accurately reflected and that no additional opinions were omitted. The revised version was defined as the “modified intervention program.” The interview guidelines are presented in Table 1. Comment 4. English fluency: Some paragraphs could benefit from grammatical simplification, especially in the Methods section. This does not affect comprehension but could increase clarity for international audiences. Response: Thank you for your comments. We have revised the manuscript for clarity and readability, particularly in the Methods section. The manuscript has been professionally edited by Editage to ensure grammatical accuracy and improve clarity for an international audience. Comment 5. Overall Review Conclusion: The manuscript is robust, rigorous, and provides a relevant intervention program for critical care settings, with the potential to be replicated in other cultural contexts. I recommend publishing it after addressing the minor formatting issues. Thank you for your positive evaluation and the constructive feedback. We are encouraged to find the manuscript robust and the intervention program relevant and potentially generalizable. We have addressed the minor formatting issues, as suggested. We look forward to hearing from you and would be happy to make further changes, Attachment Submitted filename: Response_to_Reviewers.docx pone.0346585.s006.docx (27.9KB, docx) PLoS One. doi: 10.1371/journal.pone.0346585.r003 Decision Letter 1 JONATHAN BAYUO JONATHAN BAYUO Academic Editor Find articles by JONATHAN BAYUO Author information Copyright and License information Roles JONATHAN BAYUO : Academic Editor © 2026 JONATHAN BAYUOJONATHAN BAYUOJONATHAN BAYUOJONATHAN BAYUO This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited., which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited., which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited., which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. PMC Copyright notice 6 Feb 2026 Dear Dr. Sakuramoto, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. Please submit your revised manuscript by Mar 23 2026 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at [email protected] . When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.. 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If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice. [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author Reviewer #2: All comments have been addressed ********** 2. Is the manuscript technically sound, and do the data support the conclusions??> Reviewer #2: Yes ********** 3. Has the statistical analysis been performed appropriately and rigorously? -->?> Reviewer #2: Yes ********** 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.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 #2: No ********** 5. Is the manuscript presented in an intelligible fashion and written in standard English??> Reviewer #2: Yes ********** Reviewer #2: 1) Is the manuscript technically sound, and do the data support the conclusions? Answer: Yes, it is generally technically sound; however, some conclusions require nuance to align with the actual scope of the data. • Technical soundness: The development and expert validation are described with clear procedures (FGI + web survey) and criteria for qualitative rigor (review by two researchers, expert supervision, verification with participants, qualitative saturation). • Support for conclusions: The data support the development and refinement of a program with content validity according to experts (CVI), but the abstract statement can be interpreted as a claim of already demonstrated effectiveness/consistency (“enables a more consistent delivery… regardless of individual providers’ knowledge or attitudes”). This exceeds what can be concluded without an implementation/effectiveness evaluation. Specific suggestion: Change to language such as “designed for / could facilitate / has the potential to” and maintain the conclusion focused on expert validity. 2) Was the statistical analysis performed adequately and rigorously? Answer: Yes, for the study's objective (expert validation), the quantitative analysis is appropriate; however, it is limited to content validity (it does not assess effectiveness). • The "statistical" component is primarily the Content Validity Index (CVI) using Lynn's method, a 4-point scale, calculation of the I-CVI, a threshold ≥ 0.78, and iterative modification until the threshold is reached for all items. This is explicitly described and is consistent with standard practices for content validity. • No complex inferential analyses were observed (because the design does not require them). In this sense, the quantitative rigor is appropriate for this type of study. 3) Have the authors made all the underlying data for the findings in their manuscript publicly available? Answer: Partially / not fully verifiable with the information provided in the review PDF. • • In the editorial form, they state: “All relevant data are within the manuscript and its Supporting Information files.” But for a study with FGI + CVI, “underlying data” would typically include at least: a matrix/sheet of CVI ratings per item (or complete table), an instrument (survey, interview guide), and, if transcripts cannot be shared, some level of auditable qualitative evidence (e.g., a table of topics with anonymized extracts or a codebook). In the material I reviewed, I can confirm that the statement is there, but I cannot confirm that these inputs are actually accessible as complete underlying data based solely on the system phrase. Suggestion: The authors should explicitly specify which data are in the Supporting Information (e.g., “CVI item-level ratings as S1 Dataset,” “survey instrument as S1 Appendix,” etc.). 4) Is the manuscript presented in an intelligible manner and written in standard English? Answer: Yes, it is intelligible and in standard English; minor style/consistency adjustments will be necessary. • The authors declare that they have reviewed clarity and readability, especially in the Methods section, and that the manuscript was professionally edited by Editage for grammatical accuracy and international clarity. • As a minor detail, traces of editing are still visible (e.g., small typos/duplications in some lines of the Methods section), but these do not impede comprehension. ********** what does this mean? ). If published, this will include your full peer review and any attached files.). If published, this will include your full peer review and any attached files.). 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If this link does not appear, there are no attachment files.] To ensure your figures meet our technical requirements, please review our figure guidelines: https://journals.plos.org/plosone/s/figures You may also use PLOS’s free figure tool, NAAS, to help you prepare publication quality figures: https://journals.plos.org/plosone/s/figures#loc-tools-for-figure-preparation. NAAS will assess whether your figures meet our technical requirements by comparing each figure against our figure specifications. PLoS One. 2026 Apr 10;21(4):e0346585. doi: 10.1371/journal.pone.0346585.r004 Author response to Decision Letter 2 Article notes Copyright and License information Collection date 2026. PMC Copyright notice 4 Mar 2026 Dear Dr. JONATHAN BAYUO Thank you the opportunity to revise and resubmit our manuscript, “Development and external validity of a nurse-led intervention program to improve palliative care and quality of dying and death in intensive care unit,” to PLOS One. We sincerely appreciate the editor’s handling of our submission and the reviewers’ careful and constructive evaluations, which have been invaluable in strengthening the manuscript. In response to the reviewers’ comments, we have revised the manuscript accordingly and provide a detailed, point-by-point response below outlining how each concern was addressed. We believe that these revisions have substantially improved the clarity, rigor, and transparency of the work, and we respectfully resubmit the manuscript for your further consideration. Reviewer #2: Comment 1. Support for conclusions: The data support the development and refinement of a program with content validity according to experts (CVI), but the abstract statement can be interpreted as a claim of already demonstrated effectiveness/consistency (“enables a more consistent delivery… regardless of individual providers’ knowledge or attitudes”). This exceeds what can be concluded without an implementation/effectiveness evaluation. Response: To address this, we have revised the wording in the Abstract to avoid implying demonstrated effectiveness and to better align the conclusions with the scope of this development and content validation study. Specifically, following the reviewer’s suggestion, we replaced “enables a more consistent delivery of end-of-life care in the ICU” with “was designed to facilitate more consistent delivery of end-of-life care in ICU.” For consistency, we also revised similar wording in the Discussion section. Page 27, line 399-401: Symptom management in the ICU remains suboptimal. An intervention program designed to facilitate consistent care delivery, independent of the providers’ knowledge or attitudes, may enhance symptom management. Comment 2. In the editorial form, they state: “All relevant data are within the manuscript and its Supporting Information files.” But for a study with FGI + CVI, “underlying data” would typically include at least: a matrix/sheet of CVI ratings per item (or complete table), an instrument (survey, interview guide), and, if transcripts cannot be shared, some level of auditable qualitative evidence (e.g., a table of topics with anonymized extracts or a codebook). In the material I reviewed, I can confirm that the statement is there, but I cannot confirm that these inputs are actually accessible as complete underlying data based solely on the system phrase. Response: Thank you for your important comment regarding data availability and transparency. In response, we have ensured that all relevant underlying data are accessible through the Supporting Information files. Specifically, we have added: S1 Text: Survey instrument used for content validity index (CVI) evaluation S2 Text: Item-level CVI ratings for each expert Regarding the FGI data, full interview transcripts cannot be publicly shared due to ethical restrictions and the potential identifiability of participants. However, we have provided a structured summary of themes and representative anonymized excerpts within the manuscript to ensure auditability while protecting confidentiality. We believe these additions ensure that all relevant underlying data supporting the study findings are now fully accessible in accordance with the journal’s data availability policy. Comment 3. As a minor detail, traces of editing are still visible (e.g., small typos/duplications in some lines of the Methods section), but these do not impede comprehension. Response: Thank you for this comment. We carefully reviewed the Methods section and corrected minor typographical errors, punctuation issues, and wording duplications throughout the manuscript. Attachment Submitted filename: Response_to_Reviewers_auresp_2.docx pone.0346585.s007.docx (23.9KB, docx) PLoS One. doi: 10.1371/journal.pone.0346585.r005 Decision Letter 2 JONATHAN BAYUO JONATHAN BAYUO Academic Editor Find articles by JONATHAN BAYUO Author information Copyright and License information Roles JONATHAN BAYUO : Academic Editor © 2026 JONATHAN BAYUOJONATHAN BAYUOJONATHAN BAYUOJONATHAN BAYUO This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited., which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited., which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited., which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. PMC Copyright notice 22 Mar 2026 Development and external validity of a nurse-led intervention program to improve palliative care and quality of dying and death in intensive care unit PONE-D-25-47956R2 Dear Dr. Sakuramoto, 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. Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication. An invoice will be generated when your article is formally accepted. Please note, if your institution has a publishing partnership with PLOS and your article meets the relevant criteria, all or part of your publication costs will be covered. 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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.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 #2: Yes ********** 5. Is the manuscript presented in an intelligible fashion and written in standard English??> Reviewer #2: Yes ********** Reviewer #2: (No Response) ********** what does this mean? ). If published, this will include your full peer review and any attached files.). If published, this will include your full peer review and any attached files.). If published, this will include your full peer review and any attached files.). If published, this will include your full peer review and any attached files. 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For information about this choice, including consent withdrawal, please see our For information about this choice, including consent withdrawal, please see our For information about this choice, including consent withdrawal, please see our For information about this choice, including consent withdrawal, please see our Privacy Policy ..--> Reviewer #2: Yes: Claudia Barría-SandovalClaudia Barría-SandovalClaudia Barría-SandovalClaudia Barría-Sandoval ********** PLoS One. doi: 10.1371/journal.pone.0346585.r006 Acceptance letter JONATHAN BAYUO JONATHAN BAYUO Academic Editor Find articles by JONATHAN BAYUO Author information Copyright and License information Roles JONATHAN BAYUO : Academic Editor © 2026 JONATHAN BAYUOJONATHAN BAYUOJONATHAN BAYUOJONATHAN BAYUO This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited., which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited., which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited., which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. PMC Copyright notice PONE-D-25-47956R2 PLOS One Dear Dr. Sakuramoto, I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS One. Congratulations! Your manuscript is now being handed over to our production team. At this stage, our production department will prepare your paper for publication. This includes ensuring the following: * All references, tables, and figures are properly cited * All relevant supporting information is included in the manuscript submission, * There are no issues that prevent the paper from being properly typeset You will receive further instructions from the production team, including instructions on how to review your proof when it is ready. Please keep in mind that we are working through a large volume of accepted articles, so please give us a few days to review your paper and let you know the next and final steps. 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Kind regards, PLOS ONE Editorial Office Staff on behalf of Dr. JONATHAN BAYUO Academic Editor PLOS One Associated Data This section collects any data citations, data availability statements, or supplementary materials included in this article. Supplementary Materials S1 Text. Survey instrument used for content validity indexes evaluation. (DOCX) pone.0346585.s001.docx (23.1KB, docx) S2 Text. Item-level content validity indexes ratings. (DOCX) pone.0346585.s002.docx (21.6KB, docx) S3 Text. Nurse-led intervention program to improve the palliative care and quality of dying and death in intensive care unit. (DOCX) pone.0346585.s003.docx (2MB, docx) S4 Text. Screening and conference items. (DOCX) pone.0346585.s004.docx (1.4MB, docx) Attachment Submitted filename: Response_to_Reviewers.docx pone.0346585.s006.docx (27.9KB, docx) Attachment Submitted filename: Response_to_Reviewers_auresp_2.docx pone.0346585.s007.docx (23.9KB, docx) Data Availability Statement All relevant data are within the manuscript and its Supporting Information files. 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