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design and rationale for a patient-centered communication and decision-making |nursing

design and rationale for a patient-centered communication and decision-making |nursing

Values and options in cancer care (VOICE): study design and rationale for a patient-centered communication and decision-making intervention for physicians, patients with advanced cancer, and their caregivers Michael Hoerger1,2,3,10*, Ronald M Epstein1,2,3,4, Paul C Winters4, Kevin Fiscella3,4, Paul R Duberstein1,2, Robert Gramling1,4, Phyllis N Butow5, Supriya G Mohile3, Paul R Kaesberg6, Wan Tang7, Sandy Plumb4, Adam Walczak5, Anthony L Back8, Daniel Tancredi9, Alison Venuti4, Camille Cipri9, Gisela Escalera9, Carol Ferro4, Don Gaudion4, Beth Hoh4, Blair Leatherwood9, Linda Lewis9, Mark Robinson9, Peter Sullivan4

and Richard L Kravitz6,9

Abstract

Background: Communication about prognosis and treatment choices is essential for informed decision making in advanced cancer. This article describes an investigation designed to facilitate communication and decision making among oncologists, patients with advanced cancer, and their caregivers.

Methods/design: The Values and Options in Cancer Care (VOICE) Study is a National Cancer Institute sponsored randomized controlled trial conducted in the Rochester/Buffalo, NY and Sacramento, CA regions. A total of 40 oncologists, approximately 400 patients with advanced cancer, and their family/friend caregivers (one per patient, when available) are expected to enroll in the study. Drawing upon ecological theory, the intervention uses a two-pronged approach: oncologists complete a multifaceted tailored educational intervention involving standardized patient instructors (SPIs), and patients and caregivers complete a coaching intervention to facilitate prioritizing and discussing questions and concerns. Follow-up data will be collected approximately quarterly for up to three years.

Discussion: The intervention is hypothesized to enhance patient-centered communication, quality of care, and patient outcomes. Analyses will examine the effects of the intervention on key elements of physician-patient-caregiver communication (primary outcomes), the physician-patient relationship, shared understanding of prognosis, patient well-being, and health service utilization (secondary outcomes).

Trial registration: Clinical Trials Identifier: NCT01485627

Keywords: Patient-centered care, Decision making, End-of-life care, Communication, Caregivers, Cancer, Palliative care, Quality of life, Utilization, Physician-patient relations

* Correspondence: michael_hoerger@urmc.rochester.edu 1Rochester Healthcare Decision-Making Group, University of Rochester Medical Center, Rochester, New York, USA 2Department of Psychiatry, University of Rochester Medical Center, Rochester, New York, USA Full list of author information is available at the end of the article

© 2013 Hoerger et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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http://clinicaltrials.gov/ct2/show/NCT01485627
mailto:michael_hoerger@urmc.rochester.edu
http://creativecommons.org/licenses/by/2.0
Background Crafting care that is concordant with the patient’s wishes in the context of serious illness requires clear, patient- centered communication [1]. Most patients with advanced cancer (>80%) want frank yet sensitive discussions with their physicians about prognosis and treatment choices, and want to be involved and informed about decisions regarding their care, regardless of whether they wish to assume responsibility for making major health care decisions [2]. Yet, few actually have these discussions [3]. Consequently, patients often overestimate prognoses, underestimate disease severity, and have unrealistic expec- tations for cure [2-5]. Having frank, sensitive discussions is associated with more realistic prognostic estimates and decisions that are better aligned with patients’ wishes [3,5-8]. When these discussions occur before patients are critically ill, patients report greater well-being and have fewer unwanted aggressive interventions in the last weeks of life, with no detrimental effect on survival [3,5,9]. The VOICE (Values and Options In Cancer Care) Study

is a randomized controlled trial of a patient-centered communication intervention for oncologists, patients with advanced cancer, and their caregivers. Initial study findings are expected to be published in 2013, with follow-up complete in 2015. This article describes the empirical and theoretical rationale for the study, the tailored education and coaching communication intervention, the study mea- sures and administration procedures, the planned analytic approach, and potential implications of this research.

Patient-centered communication VOICE targets important gaps in cancer communication research. Since the SUPPORT study [10], in which an ICU-based nurse intervention failed to influence care for critically ill patients with dire prognoses, there has been insufficient progress in improving clinical communication in the context of serious illness. The 2007 NCI monograph, Patient-centered Communication and Cancer Care [1], the Institute of Medicine [11], the American Society for Clinical Oncology, and the National Priorities Partnership all call for improvements in communication with patients who have serious and life-limiting illnesses, citing the effects of good communication on quality of care and quality of life. Poor communication is common in advanced cancer,

leading to healthcare decisions that are inadequately informed by patients’ preferences. Physicians often misjudge patients’ treatment preferences, desire for information, needs, and level of understanding [2,12]. Despite evidence that individuals with advanced cancer and their caregivers benefit from being informed about prognosis and treatment choices [1,2,13], physicians often intentionally overestimate survival [14] and avoid discussing prognosis until the patient has symptoms or there are no other treatments to offer, leading to inflated patient expectations about survival

and the benefits of cytotoxic treatment [4,15]. Patients who have not discussed prognosis and treatment choices with their physicians are 3 to 8 times more likely to receive aggressive treatments in the last week of life [3,5], reducing physical and emotional quality of life and perhaps longevity [9]. Additionally, patients often alter their treatment choices when adequately informed [16]. Furthermore, although physicians and patients find prognostic discussions stressful, concealing the truth can be more harmful [17]. Indeed, evidence suggests that these discussions neither appear to cause harm nor diminish hope [18,19]. Communication about prognosis and treatment choices

is essential for informed decision making in advanced cancer. Our intervention is designed to promote patient- centeredness [20], which is defined by the Institute of Medicine [21] as “care that is respectful of and responsive to individual patient preferences, needs, and values.” The intervention targets four key communication skills: Engaging patients and their caregivers to participate in consultations and decisions regarding the patient’s care, Responding to patients’ concerns, Informing patients about treatment choices, and Framing prognosis using balanced information about best and worst case scenarios. In other settings, these skills have been associated with improvements in psychological well-being, quality of life, symptoms, adherence to treatment, patient satisfaction, and caregiver bereavement, as well as reductions in racial and ethnic disparities [1,12,22-24]. If our hypotheses are supported, patients and their caregivers will be better informed, less psychologically distressed, and better able to participate in discussions about prognosis and treatment choices. As a result, they will be more likely to make decisions that lead to improved quality of life, a greater sense of peace, and better quality of death.

Ecological framework VOICE was designed to test an innovative synergistic intervention for improving communication between patients with advanced cancer and oncologists. Nearly all communication intervention studies have been indi- vidually focused on either patient or clinician behavior, or have used third parties to broker communication [25]. Such efforts have been insufficient to improve shared understanding and patient well-being. Interven- tions designed to help patients with serious illnesses to ask questions and express concerns have been more effective when physicians also encourage active patient participation [22,26,27]. Brief physician training can im- prove some aspects of communication, such as empathy. More intensive interventions have been necessary to reach broader communication goals [12,27,28]. Mindful that it may be challenging for physicians to set aside 2–3 days from a busy practice to complete training workshops, the VOICE intervention provides brief,

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highly-skilled and individually-tailored training em- bedded within the oncology practice. Further, previous research and pilot work undertaken for this trial have noted physician frustration and patient dissatisfaction when assertive patients encounter physicians who are not adequately prepared [12,22]. This suggests the need to intervene simultaneously with patients and physicians. Our trial, based on ecological theory, is the first rigorous test of an intervention that intercedes at the level of the physician-patient-caregiver relationship. Street’s ecological theory of patient-centered com-

munication (see Figure 1) [29] was used to derive the aims, intervention, and outcome measures for this trial. Ecological theory is a systems-oriented theory [30]. As such, it suggests that clinical communication research should address multiple levels, namely the mutual interactions between physicians and patients as well as the social and clinical contexts, rather than merely targeting the individual’s communication behavior. On the interactional level, ecological theory suggests that two factors – patients’ and caregivers’ assertive behaviors, and physicians’ facilitative behaviors – interact to reinforce

patients’ ongoing participation in discussions regarding their care over time [27,31]. As a result, these discussions will more closely address patients’ wishes and concerns, and patients will get more useful information, support, and empathy as well as participate in decision making to a greater degree [32,33]. Ecological theory has successfully predicted that (a)

assertive patient behaviors such as making requests, asking questions, and expressing opinions generally promote phy- sicians’ patient-centered behaviors [29,32,34], (b) physicians’ facilitative behaviors such as addressing patients’ concerns and helping patients to participate in care reinforce patient assertiveness [13,35], and (c) when caregivers are present in consultations, they can align the efforts of clinicians and patients towards common communication goals and help patients to understand and use relevant information [36,37]. Ecological theory also partially explains paradoxical results in which some outcomes, such as patient satisfaction and physician frustration, worsen when patients are trained to communicate assertively and physicians are unprepared for change [22,34]. Because of these findings, our outcome measures

Figure 1 Ecological model of patient-centered communication.

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consider both individual communication behaviors and mutual interactions. Importantly, ecological theory has been informed by

experimental research on how Framing affects patient understanding and decision-making [38,39]; as well as how Informing patients about treatment options, Responding to emotional concerns, and Engaging patients by exploring assumptions and beliefs [40-42] help patients to be more active participants in care [43,44]. Ecological theory emphasizes that patients’ desire for information should be considered by first asking patients what they wish to know and in what format, providing desired information, then checking understanding, a paradigm known as the “Ask-Tell-Ask” approach [45]. Bidirectional exchange of tailored and desired information thus leads to better shared understanding, prepares patients to be involved in decisions, and promotes trust that important information is not being withheld [17,26].

Current investigation Drawing upon this ecological framework, the VOICE intervention is designed to help physicians, patients with advanced cancer, and caregivers to communicate more effectively about issues likely to influence decision making. In doing so, this investigation brings together research on communication and medical decision making, which have historically been two separate approaches addressing common issues but without a common frame of reference. Moreover, the intervention targets patients diagnosed with incurable cancer before they become critically ill, anticipat- ing the need for information and strong patient-physician relationships as the illness progresses. We hypothesize that, relative to care as usual, the intervention will improve physician-patient-caregiver communication about progno- sis and treatment choices (Aim 1a), improve the physician- patient relationship and increase shared understanding of prognosis (Aim 1b), improve patient well-being (Aim 2), and affect health services utilization by both reducing the number of aggressive interventions that may undermine the quality of life in the last weeks of life and increasing the use of guideline-concordant palliative care and hospice services (Aim 3).

Methods/design Study design The study is a cluster RCT conducted in multiple oncology practices and cancer centers in the Rochester/Buffalo, NY and Sacramento, CA regions, designed to evaluate the effects of a theory-based intervention to improve commu- nication between oncologists and patients with advanced cancer and their caregivers. The methods were developed in collaboration with Phyllis Butow, Martin Tattersall, Adam Walczak and colleagues, who are conducting a parallel study in Sydney, Australia called Conversations with

Your Doctor: Making the Most of Medical Consultations. That study incorporates similar interventions but a different study design. The VOICE RCT incorporates many elements of effectiveness studies, such as broad eligibility criteria, usual-care controls, tailored interven- tions, patient-oriented outcome measures, and intention- to-treat analyses. The study design and all consent forms have the approval of the Institutional Review Boards at each institution. The study procedures (see Figure 2) are separated into

two phases. Phase 1 involves preparation, physician recruitment, piloting, and pre-randomization data collec- tion of physicians’ communication behaviors. Three Phase 1 patients and their caregivers are recruited for each physician. Each of these patients has one office visit audio recorded, allowing us to assess physicians’ baseline com- munication behaviors for potential use as a covariate in the RCT analyses. Phase 1 patients and caregivers also complete pilot versions of some study measures pre- and post- office visit to inform finalized versions of the measures for the RCT. Phase 2 is the cluster RCT. Physicians are the unit of

randomization and are randomly assigned to the interven- tion or control condition. Up to seven Phase 2 patients (and caregivers) are recruited per physician. Patients and their caregivers are randomly assigned by proxy: patients of physicians in the intervention condition are assigned to the intervention, and patients of physicians in the control con- dition are assigned to the control group. Patients complete measures at study entry, participate in the intervention or control condition, agree to have an oncology office visit audio recorded, and complete follow-up measures immedi- ately after the office visit, approximately 2–4 days after the office visit, and every 3 months for up to 3 years or until death. Caregivers, where available, also participate in the study and complete measures periodically, including measures one-month post-mortem. Following completion of Phase 2, data analysis will

ensue. After the study has closed, physicians from the control group will be offered the opportunity to receive the intervention, both as an incentive to participate and to further their professional development. In addition to the primary VOICE trial, additional studies are using the procedures described here to examine patient, caregiver, and oncologist emotional processes [46] that drive decision making, and the effect of the intervention on caregiver bereavement outcomes. Prior research [24] suggests that improvements in end-of-life care can mitigate bereavement-related morbidity.

Selection of study sites In the Rochester region, oncologists (n = 25) were recruited from academic and private practices in western New York; recruitment is complete. In the Sacramento

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region, all oncologists are recruited from the UC Davis Comprehensive Cancer Center (n = 14), and recruitment is nearly complete. One Rochester physician withdrew from the study prior to any data collection due to lack of time. We anticipate a total of 40 oncologists.

Eligibility, recruitment, consent, and randomization Ethical approval was obtained from the IRBs of the five affiliated institutions where the study is being conducted. All participants (i.e., patients, caregivers, and oncologists) complete written informed consent documents. Specific inclusion and exclusion criteria are presented in Table 1, and participant eligibility is verified immediately prior to completing baseline study measures.

Oncologists Medical oncologists who care for patients with solid (non-hematologic) cancers are solicited for participation through presentations about the study at grand rounds and faculty meetings, or through personal contacts via cancer center directors or project investigators. Interested oncologists then meet with study personnel (e.g., project manager, research Helpant, or research oncologist) to achieve a clear understanding of all study components, provide written consent, and complete the baseline surveys. The consent document seeks each oncologist’s agreement to (a) guide recruitment efforts among their patients

by determining eligibility, (b) participate in an educa- tional program to enhance their communication skills, (c) audiotape one clinic encounter per enrolled patient, and (d) complete brief surveys at baseline, after each audio-recorded office visit, and the study conclusion. Oncologists are told “the purpose of this study is to assess the impact of brief educational interventions on clinical care and outcomes of patients with cancer and their caregivers. Outcomes of interest include communication between patients, caregivers, and physicians, as well as pa- tient well-being and health services utilization.” Oncologists receive $600 for completing surveys and identifying eligible patients for the study.

Patients Research Helpants identify all patients by working closely with participating oncologists and their clinic staff to review clinic rosters in detail to ascertain that all potentially eligible patients are identified. Depending on the site and differing IRB requirements, potentially eligible patients are either (a) approached by physicians or practice nurses and then by the research Helpant or (b) sent a letter, a study brochure, and an opt-out card. Patients approached by physicians or clinic staff are asked if they would be willing to speak to a research Helpant to learn more about the study. Patients who receive recruitment materials by mail are contacted via

Recruit Oncologists R

Oncologist Training

Intervention

Oncologist Control

Patient/Caregiver Coaching

Intervention

Patient/Caregiver Control

PRIMARY OUTCOME MEASURES

Audio-Recorded Office Visit

SECONDARY OUTCOME MEASURES

Patient/Caregiver Follow-up Surveys

Medical Record Audit

Pre-RCT Audio Recordings

Figure 2 VOICE study design.

Table 1 Inclusion and exclusion criteria for oncologists, patients, and caregivers

Participant Inclusion criteria Exclusion criteria

Oncologist ● Currently in clinical practice at participating institutions ● Non-physicians and physicians who are not oncologists

● Oncologist that cares for patients with solid tumors ● Not planning to leave the practice during the next 6 months

● Oncologists who exclusively care for patients with hematological malignancies

Patient ● Currently a patient of an enrolled physician ● Age 21 years or older

● Anticipating bone marrow transplantation or diagnosed with leukemia or lymphoma

● Diagnosis of Stage III or IV solid (non-hematological) cancer a ● Unable to complete orally-administered surveys in English

● Able to understand spoken English (study personnel to read materials to low literacy patients)

● Hospitalized or in hospice care at recruitment or for baseline measures

Caregiver ● Caregiver of a patient currently enrolled in the study ● Unable to complete orally-administered surveys in English

● Age 21 years or older ● Supported the patient primarily through a professional role (e.g., clergy)● Able to understand spoken English

(study personnel to read materials to low literacy caregivers) a Patients with Stage III cancer are included only if they have a limited prognosis. Their oncologist must affirm that they “would not be surprised” if the patient died within 12 months, thereby excluding patients with potentially curable Stage III cancers, such as Stage IIIc testicular cancer or Stage IIIa colon cancer.

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phone by a research Helpant if an opt-out card is not returned to the research office within 7 days. The research Helpant provides them with study information, and gives them time to deliberate about participation and ask ques- tions. The screening and consent process continues until the research Helpant feels that the potential participant fully understands all aspects of study involvement. The research Helpant then schedules a time to meet and obtains written consent from those who voluntarily wish to enroll, using IRB-approved consent forms. Patients are reminded that they can opt out at any time. All patients are asked to complete baseline surveys and to give permission to have one of their oncology office visits audio recorded. The research Helpant orally administers the baseline surveys as well as other study materials as needed. If consent documentation and baseline survey measures are completed in separate visits, eligibility criteria are reviewed immediately prior to survey administration to ensure continued eligibility. Phase 1 patients complete two sets of orally-administered

surveys, one before and one after the audio-recorded office visit with their oncologist. Phase 2 patients (a) have one audio-recorded office visit with their oncologist, (b) complete surveys prior to and immediately after their office visit, then 2–4 days after the office visit, and every three months for up to three years, and (c) give permission for research staff to access their medical records to ascer- tain their use of health services such as emergency department visits, hospital admissions, cancer treatments, and community-based nursing services. The initial survey takes up to 60 minutes with later surveys taking anywhere from 10 to 30 minutes. Patients receive $15 for each set of surveys, for a maximum of $30 in Phase 1 and $180 in Phase 2.

Caregivers All patients are asked to identify a “family member, partner, friend or someone else who is involved with your health care issues, for example, someone who you talk to about personal issues including medical decisions or who comes to doctor appointments with you. This person may also help with routine day-to-day activities, like transportation or paperwork.” The term “caregiver” is used to describe these persons for scientific purposes, and patients are not required to self-identify individuals as such. Patients are asked to identify up to three potential caregivers, rank them in order of the likelihood that they will attend oncology office visits, and provide permission to contact the primary caregiver (or others caregivers, if needed) and provide them with a study brochure. Once identified, the research Helpant independently

approaches the caregiver in person or by telephone and asks if they would be willing to participate and provide written consent. Caregivers often accompany patients at

the time of the patient consent. The research Helpant reviews the consent form in detail with the caregiver and advises them that they can opt out of the study at any time. Caregivers are told the same study details as the patients and complete surveys at approximately the same time intervals as the patients. Caregivers are asked for permission to be contacted in the event that the patient dies within three years of enrollment in order to meet with a research Helpant (or speak on the telephone if preferred) to complete a survey. The survey is completed approximately one month after the death of the patient. The research Helpant responds to caregivers’ questions until it is clear that the caregiver has full comprehension of the consent form and their involvement in the study. Caregivers receive $15 for each set of surveys, for a maximum of $30 in Phase 1 and $180 in Phase 2.

Randomization A stratified block-randomization scheme is used to assure balanced assignment by clinic site and cancer focus. Oncologists are grouped into a site according to their health center, clinic, or practice of employment. Within each site, oncologists are randomly assigned approximately evenly across the treatment and control conditions. Sites with a single oncologist are grouped with a similar site for randomization purposes. Oncologists are also categorized by their cancer focus, including breast-cancer oncology (≥50% of patients have diagnoses of breast cancer) and non-breast cancer oncology groups. Within these areas of focus, oncologists are randomly assigned approximately evenly across the treatment and control conditions. This accounts for any biases that may be introduced by the low prevalence of breast cancer in men and the potential that breast cancer patients may be more “activated” than patients with other cancers. For each site/focus combination in the study, separate sequences of ran- dom numbers have been generated for use in assigning oncologists to the intervention and control groups. To preserve blinding, assignment to the treatment or control conditions is maintained by the study statistician and not explicitly revealed to transcriptionists or coders of the audio-recorded office visits.

Visit procedures For the initial baseline surveys, a time is arranged to meet with the patient and caregiver, either together or separately, in a private area based on the participant’s comfort and preference. This may include a meeting room in the cancer center, the infusion suite, the partici- pant’s home, or a local coffee shop with private areas. Once both the patient and caregiver have completed these surveys, the research Helpant answers any questions and reviews the next steps of the study, the audio-recorded office visit and post-visit survey. For that visit, the research

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Helpant usually meets the patient and caregiver in the physician’s waiting room and accompanies them to the clinic room, turns on and places two audio recorders in the room, and leaves. If another person attends the visit, the research Helpant obtains verbal permission to record them. The research Helpant collects the recorders after the office visit and meets with the patient and caregiver to administer brief surveys. This completes Phase 1. In Phase 2, the scenario is identical, except that the patients and caregivers in the intervention arm receive a 1-hour coaching session prior to the office visit. After the audio- recorded office visit, the patient completes a survey, and the research Helpant explains to the patient and caregiver that they will be contacted in 2–4 days by phone to answer some additional questions. The patient and caregiver are also called three months after the audio-recorded visit to complete surveys and every three months thereafter for up to three years.

Description of the intervention and control conditions Intervention condition Oncologists randomized to the intervention arm participate in a multifaceted tailored educational intervention involving standardized patients instructors (SPIs). Patients and caregivers complete a coaching intervention to facilitate prioritizing and discussing questions and concerns.

Oncologist training Oncologists completing the interven- tion meet with SPIs for two in-office educational outreach sessions [47], including a 60-minute training session and a 45-minute booster session [48]. At the first session, the SPIs show them a 15-minute DVD created by the study investigators specifically for this project, which presents actual clinical examples to outline key skills in discussing prognosis and treatment choices with patients with advanced cancer and their caregivers. Oncologists receive a copy of the DVD to keep and receive a 1-page summary of evidence-based guidelines for communication in ad- vanced cancer [13]. They are also given a Communication Guide “reminder” card prompting them to discuss topics, such as prognosis and symptoms that appear on the patients’ Question Prompt List, such as prognosis and symptoms (see below, QPL). After viewing the DVD, the oncologist is asked to

select one or two of the key skills to practice with two SPIs who portray a 60-year-old man with incurable cancer and his wife. A few days prior to the session, the oncologist is sent a medical “chart” to review in anticipation of the SPI visit, containing a comprehensive prior con- sultation note which includes radiographic and laboratory results. In the “chart,” the patient is described as having metastatic colon cancer with progression despite one course of state-of-the art chemotherapy, and intolerance of a second course of chemotherapy. Current symptoms

include severe diarrhea, nausea, and fatigue. The SPIs present as facing important treatment decisions over the next few weeks, while having an unclear idea of prognosis. The SPIs engage the oncologist in a role play exercise with specific tailored feedback on the key communication skills described in the DVD; oncologists are then given the opportunity to rehearse areas of difficulty. Oncologists also receive a follow up letter from the SPIs that includes a version of the communication guide with individually- tailored comments. The guide shows the four key skills discussed in training and summarizes what was agreed to by the oncologist and SPIs during the session, such as the physician’s demonstrated areas of strength, as well as those areas jointly identified as challenges for further growth. One month later, oncologists complete a 45-minute reinforcement session, which uses a similar format. Specifically, the same SPIs return for a simulated follow-up visit, where the cancer has “progressed” despite third-line treatment. Key communication skills highlighted in the DVD and SPI feedback (see Table 2) were chosen based on ecological theory and evidence that they (a) promote discussions of prognosis and treatment choice, (b) can be taught in brief interventions, and (c) are associated with patient trust and lower anxiety [13,49-51].

Patient and caregiver coaching Patients and car

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