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Methods | cancer, illness | CANCER | This study applied a qualitative method using a narrative research design by collecting self‐stories of illness in order to conceptualize human experiences of illness among AYA cancer survivors. Eight in‐depth interviews were conducted using a narrative analysis according to the narrative plots of | PMC10075285 |
Results | cancer, Hopelessness, ill | CANCER | Hopelessness and a struggle to take part in the activities of daily life as survivors of cancer were revealed. Too ill to fully take part in the society, the AYA cancer survivors strive to be understood for what they are, namely young survivors. | PMC10075285 |
Conclusion | cancer, Cancer | CANCER, CANCER | The survivors'stories reveal a moral imperative that needs to be honored by medical professionals in order to improve cancer care. Cancer survivorship may be a lifelong process necessitating long‐term follow‐up care. With the lack of specific care programs for AYA cancer survivors, follow‐up care is provided by general practitioners or other medical professionals, who often lack expertise in the unique challenges faced by AYA survivors. Because they feel their needs are unmet and their stories not understood, the AYA survivors might experience a sense of abandonment. By adopting a care ethics and narrative medicine approach we provide medical professionals a theoretical framework to better understand and care for AYA cancer survivors. Clinical trial number is 2012/1141.
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BACKGROUND | cancer, Cancer | CANCER, CANCER | Cancer survival rates have increased over the past 40 years due to modern cancer therapy.There is a lack of consensus as to what age defines adolescents and young adults (AYA).Internationally, AYA cancer patients are gradually being recognized as a distinctive population in oncology as a result of the unique challenges this group faces.Survivors of cancer attempt to transition to a “new” normal life. | PMC10075285 |
Illness narratives | cancer | CANCER, DISEASE, FRANK, LENS, FOUNDERS | By telling one's story, one can give meaning to the seemingly meaningless. The AYA cancer survivors in this study were just about to establish a life of their own as adults when interrupted by disease. This seemingly senseless situation might be given a sense of meaning through the act of telling their stories to others. Narrative medicine is, according to one of its founders, Rita Charon, “medicine practiced with the competence to recognize, absorb, interpret and be moved by the stories of illness”.As our aim was to investigate the particular challenges encountered by the AYA cancer survivors, and how they viewed themselves in light of their illness experiences, we studied their stories of the self through a narrative lens. In these narratives, the teller is the AYA cancer survivor while the listener is the medical professional caring for them. By telling their stories, the AYA cancer survivors have chosen a certain narrative identity for themselves. These identities were investigated in this study by using the plots suggested by Arthur Frank.To the teller, the story is the bridge between their past self and their present self. A Canadian study investigated how illness narratives served to renegotiate identity among a heterogeneous group of cancer patients. It found that cancer survivors' illness narratives helped them negotiate their way through treatment regimens, changes to their bodies and disrupted lives. Thus, their stories became vehicles for making sense, not of an illness, but of a life. | PMC10075285 |
Ethical and philosophical perspectives | To capture the central values inherent in the participants' narratives, we focused on participants' subjective experiences and personal narratives, as well as their relationships with family, friends, and medical professionals. The ethics of care is the ethical perspective most relevant to this study. | PMC10075285 | ||
AIM AND RESEARCH QUESTIONS | cancer | CANCER, LATE EFFECTS | Surviving cancer successfully entails more than just immediate physical survival. It has been well established that AYA cancer survivors have a higher risk of long‐term and late effects of cancer, and they are in a unique phase of life in regard to psychosocial, cognitive and emotional transitions.This study attempted to establish a better understanding of what it is like to make the transition from being sick to being well, struggling with side effects of cancer, while also transitioning from childhood to adulthood. Conducting a narrative analysis, allowed us to arrive at a broader understanding of how the AYA cancer survivors talk about their illness experiences and what truths they reveal about themselves. The aim was to explore how illness stories help survivors negotiate a new identity based on their illness experiences. Moreover, we explored the ethical implications inherent in these stories to health care professionals in general and general practitioners in particular. The following questions were addressed:What particular challenges do AYA cancer survivors have?How do they view themselves in light of their illness experiences?To what extent do AYA cancer survivors feel their concerns are addressed and understood by their medical caregivers? | PMC10075285 |
METHODS | PMC10075285 | |||
Design | cancer, illness | CANCER, FRANK | This study applied a qualitative method using a narrative research design that involved collecting self‐stories of illness to conceptualize human experiences of illness among AYA cancer survivors. In our analysis, the narrative plots of “restitution,” “chaos,” and “quest” as suggested by Arthur Frank (see below) were adapted to the narrated experiences of the participants. | PMC10075285 |
Participants | cancer, Cancer | CANCER, RECURRENCE, CHILDHOOD CANCER, CANCER | Participants were recruited via the Norwegian Cancer Society by attending patient association meetings, as well as via Facebook and posters in oncology clinics. Adolescent survivors of cancer who had diagnosed with cancer or had had a recurrence in the age‐range of 15–35 years and at least 1 year post‐treatment were invited to participate. Each potential participant was made aware of the study procedures, risks and benefits. Written consent was obtained prior to the interviews and all participant identifiers were removed and the participants were given fictitious names. Eleven people wished to participate. Two participants declined to join after the initial contact was made. One had a relapse and was receiving therapy and therefore no longer met the inclusion criteria. Eight participants remained, two of which were men. Four participants were survivors of childhood cancers, while the others had been diagnosed in their teens. At the time of the study, the participants' ages ranged from 18 to 35. | PMC10075285 |
The interviews | cancer, negatively?As cancer | CANCER, DISEASE | Eight loosely semi‐structured, in‐depth qualitative interviews were conducted using open‐ended questions. The first questions were designed to make the participant freely tell his or her story.Interview guideWould you please tell me about yourself and your experiences in light of having struggled with cancer at an early age?How did friends, family and co‐workers, etc. respond to you disclaiming having had cancer or even having side‐effects of cancer therapy (if any side‐effects are mentioned)Has your disease affected your education or career choice either positively or negatively?As cancer therapy ended, to what extent did you feel you could pick up where you left and return to the life you had before you received the cancer diagnosis?If this applies to you, to what extent do you feel understood and your concerns met by your general practitioner?Would you like to listen through the recording?Is there anything you wish deleted?Are there any questions I should have asked you, or not have asked at all? | PMC10075285 |
Data processing | The transcribed interviews were read closely by three of the authors (KH, PN, and MHH) individually to identify emerging themes, topics and plots. The authors met regularly to compare and discuss their individual findings. The fourth writer (HB) was involved after the initial analysis was done to secure validity by undertaking an independent analysis confirming the identified themes and plots were reflective of the data. | PMC10075285 | ||
The analysis | illness | A narrative analysis was conducted looking at the themes that emerged during the interviews as well as how the tellers structured their stories of self. The themes and structures are discussed separately. Firstly, themes and topics of concern to the participants were identified and considered together to develop larger groupings of themes and categories. Second, we re‐read participants' stories to determine how they were constructed, meaning we looked not only at the contents of the narrative but also its form (i.e., temporal course, plots, and subplots) in order to achieve insight beyond the spoken words.The structural part of the analysis was largely inspired by Arthur Franks book RestitutionThe restitution plot reflects the desire to recover from illness and has become the narrative that models how illness is to be described.ChaosThe chaos plot imagines life never getting any better.QuestThe quest plot is defined as the survivor having accepted his illness and believes something is to be gained through the experience. These storytellers accept illness and seek to use it. There is a sense of purpose, and the survivor may desire to help others. | PMC10075285 | |
Ethical concerns | Cancer | CANCER | As the quality of the data collected could potentially activate a reflexive process among the participants and lead to psychological distress, the participants were offered support by a nurse representing the Norwegian Cancer Society. The study was reviewed and accepted by the regional ethics review board (REK in Norway). File number 2012/1141. | PMC10075285 |
RESULTS | PMC10075285 | |||
Sample characteristics | cancer, cancers, tumors | OVARIAN CANCER, CANCERS, LATE EFFECTS, CANCER, DISEASE, TUMORS, ACUTE LEUKEMIA | Two men and six women aged 21–34 participated in this study. They had been diagnosed with different cancers at different stages of late childhood and early adolescence. One participant had ovarian cancer. Both men suffered from tumors of the central nervous system (CNS) and four women suffered from acute leukemia. Only one of the men had a higher education and a steady job. Four of the six women were pursuing a higher education while one had a steady job. All participants suffered some degree of late effects of cancer and felt milestones in adolescence had been significantly affected by their disease. Four participants were single and claimed this was a result of their disease. The other four were in partnerships. Neither of the male participants was in romantic relationships. The sample characteristics are based on the information spontaneously provided during the interviews as no one was asked specifically about marital status or other personal details. See Table Sample characteristics ( | PMC10075285 |
Three emerging themes | cancer, ill | CANCER | Several themes emerged from the interviews. All participants addressed three major themes, which are the basis for this study. The first theme deals with the situation of being neither ill, nor well because of the struggle with the side effects of cancer therapy. The second describes the complicated life phase in which AYA cancer survivors find themselves as they transition from childhood to early adulthood while battling these side effects. The third theme comprises the sense of abandonment and continuous chaos the participants experience when they have no one to turn to for help with their troubled bodies and troubled selves. | PMC10075285 |
Neither ill, nor well: A remission society | hopelessness, shock, cancer, tiredness, ill, osteoporosis, Cancer | SHOCK, CANCER, BRAIN TUMORS, REMISSION, SAID, OSTEOPOROSIS, CANCER | The experience of being neither ill, nor effectively well was explicitly described by all of the participants: “My life is split in two. I live two different lives, and it takes a lot of hard work to separate the twoMargret, a 30‐year‐old anthropologist, got sick while at the university: “Once you have finished therapy you think 'Hurray, I am healthy! '. But in reality, you are young and cured, but still you have a body that has been beaten up badly for months and no longer works as it should.”Another woman, a 22‐year‐old nursing student named Sophie, described the frustrations of facing side effects after cancer therapy while the people around her expected everything to be back to normal very well: “People expect you to be all good when you finish cancer therapy. But what actually happens is that one thing after another shows up, and maybe you will never be any better. I ended up with osteoporosis and a prosthetic hip, and then there is this extreme tiredness and I couldn't even go to school”. She added: “You hardly hear about side effects. You're not prepared. It comes like a shock. You are treated to be cured, but you kind of don't get well. And you certainly cannot start living just like your friends do when you are out of it.”To some, remission from cancer is even more devastating than the illness itself: “Cancer therapy is like entering a machine only to get out of it with a weaker body and fewer options in life,” said Jack, a 21‐year‐old man, who had survived multiple brain tumors at the age of ten and during his early teens. He never managed to finish school or get a higher education. He was still struggling with finding a job and making friends.As survivors of cancer, all the participants expressed frustrations related to the many severe side effects they suffered after cancer therapy. They felt unprepared for the situation they found themselves in and further expressed a sense of hopelessness at not being effectively well despite being cured from cancer. | PMC10075285 |
In a unique position: Transitions from sickness to wellness, and from childhood to adulthood | ovarian cancer, tumor, illness, cancer, leukemia | OVARIAN CANCER, TUMOR, LUNG FIBROSIS, CANCER, LEUKEMIA, BRAIN TUMOR, SHOCKING, SAID, IMPOTENT, CHRONIC FATIGUE SYNDROME (CFS) | The conflict between sickness and wellness coincides with the AYA cancer survivors' young age at the time of diagnosis, which puts them in a unique position. As Anita explained, “It is a special thing getting sick as a teenager. I had not had the chance yet to develop a life as an adult.”June (27), who had been diagnosed with ovarian cancer at the age of 16, was struggling with chronic fatigue syndrome (CFS) and lung fibrosis: “I went back to school after I got sick. That became very difficult. I was so terribly tired. I did not manage to take part in the class. Besides, I had completely different experiences and a completely different perspective on life than my class mates. My class mates were not any nice to me at all. Because I had been away from school so much, I was no longer welcome in the group. I have to live life completely differently from how I did before.”Margret described it as a shocking transition when her cancer therapy was over: “I really had nothing to go back to. I mean I had a sick leave from my studies, but no job. All the friends I had had something to do. I just had to sit there with nothing. You know, cancer is not just like an interruption or a break from your life the time you are in therapy and then when it's over you can just pick up where you left off!”Ingrid (34), who had twice survived a brain tumor, felt as if she had lost important years of her life to cancer. “Ten years really, yes definitely 10 important years from the time I was 20 till I was 30, have been stolen from me, sort of. I feel I lag a bit behind other people at my age.”Caroline (20) had to give up law school when she was diagnosed with leukemia. “Getting cancer this young is a very special thing. You are neither a child nor an adult, and yet in a difficult situation like that (having cancer) you are supposed to figure out who you are!”In these examples, the participants describe a sense of being cut off from the lives they used to live. They are standing on the threshold of adult life, struggling to navigate a new life after cancer while feeling they have lost important years of their adolescence to their illness. Their experiences are so different from those of their peers that they sense a kind of alienation. Restitution of normality after undergoing cancer therapy is that ideal; however, all the participants seemed to find it difficult, apart from one, Mark, making him an exception to the rule.Mark (30) was diagnosed with a CNS tumor. This caused him to end up paralyzed, impotent, and infertile and with two ostomy bags. “Despite all that, I have a life pretty much like the one I had before I got cancer. I still get to do the things I love. I have been very lucky to have a close network of friends and family. I have also been very fortunate to have an employer who said, the minute he found out about my cancer, that my job was the last thing to be worried about.” Mark's story indicates the importance of a well‐established network of friends, family and colleagues for being able to pick up where one left and move on—in other words, having an old life to fall back upon. | PMC10075285 |
Hopelessness and no places to turn for help | cancer, depressions, fatigue, ill | CANCER, SAID | So far, our findings reveal the hopelessness of adolescents who are neither being sick nor well after battling cancer therapy. Their sense of hopelessness, it seems, is even greater when there are few places to turn for help. All the participants expressed frustration at having nowhere to turn for follow‐up care, or having to re‐tell their stories every time they see a new health‐care professional or social worker. Three of them were more articulate than the others, putting into words the frustration that all participants had to some degree.For Ingrid, the trouble started when she was discharged from the hospital. She struggled greatly with both the side effects of cancer therapy and not finding a doctor to provide her with the follow‐up care she thought she needed. Secondly, friends and family expected everything to be back to normal when her cancer treatment ended. However, Ingrid suffered from fatigue and depressions and felt left to herself when her parents said she should be happy and just pull herself together. Ingrid was also without a job and as she tried to explain her situation to her social workers, she felt they, too, were unable to understand the limitations of her work capacity: “Nobody understood what I felt. It feels horrible when neither nurses, doctors, nor social care takers seem to understand.”Mark claimed that a greater competence in understanding each patient's unique challenges is required: “Many of us get sick while we still are kids in the children's ward but end up being transferred to the cancer ward for adults. It is very important to make that transition smooth. This is not just about the hospital as a system: every individual medical professional must keep in mind what that means to the patient.”Ingrid said, “I really wish someone had helped me or at least given me some advice to make the transition from sick to well a little better – helped me return to a normal life. I just felt incredibly empty after the treatment”.Mark expressed a similar concern: “Being an adolescent in a situation like that, is completely different from being an adult. We are just starting our lives! I think the medical professionals need to understand that we are not like other adolescents. The doctors should think of what we, the young patients, are concerned with and adjust the way they think and talk to us!”Caroline sometimes felt she was not taken seriously by the medical professionals treating her: “I was constantly compared to the older patients. Therefore, I felt they didn't take my concerns seriously.”The participants claimed they were not offered follow‐up cancer aftercare that adequately addressed their specific needs. This, it seems, contributed to a greater sense of hopelessness when battling the side effects of cancer and feeling neither ill nor well. The participants also seemed to hold the medical professionals responsible on a more personal and individual level rather than seeing this is a problem related to how medical care is structured and organized. | PMC10075285 |
The survivor as narrator – narrative structures | Because this study was interested in how the participants revealed their selves through the act of telling their stories, we shifted our attention from what was being told to the telling. This shift meant looking at how the stories were organized and put together to better see what a particular story did and really was about. Attention to narrative form adds insight beyond what a simple focus on themes can provide alone. | PMC10075285 | ||
A story of restitution | cancer, pain | CANCER, CHRONIC PAIN | Sophie's story is one of restitution. Her restitution is not limited to the absence of pain, but also includes the establishment of new meaning in her life. She has gained a reflective grasp of what she has lived through. The choice of restitution rather than chaos as the dominant narrative element relates to her story's turning point: “It probably was what my doctor told me: “There is a chance you never will get any better, but if you do, it is a bonus.” Well living with that uncertainty—will I get any better or not?—that's frustrating. But after that, I started thinking this is as good as it gets. This is all I can expect. I was no longer waiting and hoping for something better. It was impossible to find peace that way.”Being a cancer survivor requires accepting some level of illness. Sophie has accepted her illness after having received help in doing so: “I started getting help from the clinic for chronic pain. They have a different way of thinking and know what I am going through.” | PMC10075285 |
A story of chaos | cancer, chronically ill | CANCER, FRANK, CHRONICALLY ILL | Chaos dominates Ingrid's story: “I wanted to give up. But the reason why I am disabled today is not the cancer. It is that I have not received any help. That is why I am disabled. It is no fun in receiving unemployment benefits. I feel I am staying put. This happened when I was 20, now I am 34, I still haven't recovered. I should have been working. I don't believe in myself anymore. Nobody needs me.”In Ingrid's case, the restitution narrative fails. And for the chronically ill there are no other stories to fall back upon. Their sense of chaos and hopelessness continues and must therefore, be acknowledged by medical professionals and other care takers. This need is both moral and clinical, as Frank puts it. | PMC10075285 |
The quest | The teller of a quest story has gained an insight that must be passed on to others.All participants were involved in the patient associations to varying degrees believing they should pass on the experiences they had gained. As Mark put it, “It is about using the negative experiences, and turning them into something positive.” Mark used this logic to explain why he visited with newly diagnosed teens in the hospital wards, saying: “I feel I have something to give to others.”Although he is constantly being interrupted by illness, Mark is grateful for whom he has become. Even if he must be in a wheelchair, he is grateful for the perspectives on life he has gained: “What matters is to make a difference in somebody's life.” | PMC10075285 | ||
Multiple stories, one narrator | cancer | CANCER, REMISSION, STILL | The participants' stories had different plots depending on what they were talking about and the situation they were describing. In illness narratives, all the suggested plots appear alternatively and repeatedly. Still, at any given moment, there is one plot that predominates. Accordingly, the participants revealed the coexistence of multiple plots, thus serving as an example of the fact every storyteller is telling multiple stories.Though Mark has an explicit quest, his story is just as much a story of restitution. It illustrates the importance of having an old life to fall back upon as he had completed an education and even had a job prior to his diagnosis.In some of the stories, the narratives of chaos and restitution coexist and fight each other. Anita lives a relatively normal life, still feels the need to hide the side effects of her treatment as though she has something to prove, namely that she is still the same person. While she tells herself that everything will be as it was before, that she is “a regular person and no longer a cancer survivor”, she is frustrated by the appearance of new side effects. “I realize I have no idea what the future brings,” she says, thereby admitting she will likely forever be a member of the remission society and continue to be neither sick, nor well. | PMC10075285 |
DISCUSSION | PMC10075285 | |||
Interruptions | illness | Living with illness is living with perpetual interruption. | PMC10075285 | |
A new approach | cancer, cancer survivors face significant challenges | CANCER, STILL | AYA cancer survivors face significant challenges when transitioning into adulthood. For one, they may become marginalized as patients are medically and legally considered children until the age of 16 years. Still, the challenges facing the AYA cancer survivors are far different from both pediatric and adult cancer survivors.A growing number of research articles examine the various aspects of the experiences of young adult cancer survivors, but still this evidence suggests a strong need for an expansion of the knowledge of how AYA cancer survivors are understood and understand themselves. | PMC10075285 |
Young members of the remission society | cancer | CANCER, FRANK, REMISSION | The participants in this study illustrate both the difficulty of recovering from cancer and the extent to which the transition to early adulthood is affected by their illness. Though the participants have reached a “new” normal life, the restitution plot becomes problematic when the survivor is still battling the side effects of cancer therapy. Considering how the restitution plot has become the preferred narrative of institutional medicine and powerful interest groups, and has thus come to shape the culture of illness, survivors may feel there is nowhere to turn when other plots prove possible. Medicine still tends to view people as either sick or well. Arthur Frank, however, argues that being a survivor of cancer is less about holding dual citizenships than it is about living with perpetual chaos in a so‐called remission society. In a remission society, sickness and health constantly blend into each other.AYA cancer survivors are particularly vulnerable. A similar vulnerability is more poetically addressed by Remarque in his novel about World War I, | PMC10075285 |
A lack of care, a lack of connectedness | voice of illness, cancer | CANCER, LATE EFFECTS | Though many of the frustrations the participants expressed could be connected to how the health care systems and of follow‐up care are organized in Norway, the participants expressed their frustration at having their needs unmet and revealed a sense of hopelessness when not provided with sufficient information or not feeling understood by their medical professionalsHealth care professionals witness the plight of others. Health care is about bestowing attention on the patient. All clinicians act as meaning‐making vessels for the patients when they recount their individual situation.The harm caused in relationships by a lack of care and responsibility is the main focus of the ethics of care.Many care ethicists emphasize that ethical responsibility, in this case doctors' responsibility to their patients, must fundamentally be seen as an answer to the voice of illness and the expressions of vulnerability, as well as to the strength and the resilience shown by AYA cancer survivor.The lasting physical and psychosocial late effects of cancer in AYA cancer survivors are only understood by health care professionals to a limited degree. | PMC10075285 |
Implications and limitations | cancer, weakness, illness | CANCER, RECRUITMENT, STILL | This study provides further insights into how AYA cancer survivors understand themselves after going through cancer therapy while attempting to re‐enter into the lives they once lived. They are forever affected by their experiences. With its narrative approach, this study provides knew knowledge as to how the experiences of young adult survivors are narrated as individual stories of illness and survivorship. We believe this is of great importance because the experiences of the young survivors 1 day will become the experiences of survivors having grown old.One important limitation is the small number of participants. The recruitment of AYA cancer survivors willing to tell their stories is difficult. Surviving cancer is a lonely endeavor possibly still associated with stigma, which means that important voices may not have been heard. Another weakness is the gender balance as only two men wished to participate. Differences in time periods between the different stories have not been investigated due to the small number of participants. It is likely, however, that the participants told their illness stories differently and had achieved different levels of reflexivity regarding their cancer trajectories based on the length of their rehabilitation period and the time since diagnosis. The relatively low sample size may cause a risk of bias as only the stories wanting to be heard were told. Meaning, there is a chance of a “non‐response” as only those feeling strongly about the topic participated thus challenging the variability of the results. Still, qualitative studies can reach saturation at relatively low sample sizes when the objectives are narrowly defined as in this study. | PMC10075285 |
CONCLUSION | cancer, hopelessness, cancer survivors | CANCER | The results suggest a sense of hopelessness among the AYA cancer survivors. Despite being cured from cancer, they still cannot regard themselves as well. Furthermore, the findings speak to a lack of information specific to this group, as well as a lack of places available for help and follow‐up care. The existing literature stresses the importance of establishing developmentally appropriate support for AYA cancer survivors and taking a biopsychosocial view of AYAs during both cancer therapy and survivorship. | PMC10075285 |
AUTHOR CONTRIBUTIONS | PMC10075285 | |||
CONFLICT OF INTEREST | All authors declare that they have no conflicts of interest. | PMC10075285 | ||
ETHICS STATEMENT | This study conforms to the recognized standards according to the Declaration of Helsinki. The Regional Ethics Committee of South East Norway approved this study (REK Sørøst). Clinical trial number is 2012/1141. Written consent was obtained from all the participants. | PMC10075285 | ||
ACKNOWLEDGMENTS | Cancer | CANCER | We want to thank the participants who agreed to share their stories with us. We also wish to thank the Norwegian Cancer Society (Kreftforeningen) and UNGKreft for their help in organizing the study. No external funding was received. | PMC10075285 |
DATA AVAILABILITY STATEMENT | The data that support the findings of this study are available from the corresponding author (KH) upon reasonable request. | PMC10075285 | ||
REFERENCES | PMC10075285 | |||
Background | Whether body mass index (BMI) is a risk factor for poor bowel preparation is controversial, and the optimal bowel preparation regimen for people with a high BMI is unclear. | PMC10698874 | ||
Methods | We prospectively included 710 individuals with high BMIs (≥ 24 kg/m | PMC10698874 | ||
Results | colonoscopic bowel | After enrollment, 15 individuals didn’t undergo colonoscopy, finally 345 participants took 3 L split-dose PEG regimen, and 350 participants took 2 L PEG regimen for colonoscopic bowel preparation. 3 L split-dose PEG regimen was superior to 2 L PEG regimen in the rate of adequate bowel preparation (81.2% vs. 74.9%, | PMC10698874 | |
Conclusions | overweight | 3 L split-dose PEG regimen is superior to 2 L PEG regimen for colonoscopic Bowel Preparation in relatively high-BMI individuals, especially overweight individuals (BMI 25-29.9 kg/m | PMC10698874 | |
Trial Registration | This trial was registered in the Chinese Clinical Trials Registry (ChiCTR2000039068). The date of first registration, 15/10/2020, | PMC10698874 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12876-023-03068-9. | PMC10698874 | ||
Keywords | PMC10698874 | |||
Introduction | CRC, malignancy, stroke, cirrhosis, inadequate bowel, constipation, overweight, Colorectal cancer | OBESE, HYPERTENSION, STROKE, DIABETES MELLITUS, CIRRHOSIS, COLORECTAL CANCER | Colorectal cancer (CRC) is the third most common malignancy and the second leading cause of cancer-related mortality worldwide [Several risk factors have been reported to be associated with inadequate bowel cleaning, such as age, male sex, constipation, diabetes mellitus, hypertension, cirrhosis, and stroke [Polyethylene glycol (PEG) solution is currently the most widely used for bowel cleansing before colonoscopy, and in most west countries, 4 L PEG solution is the standard bowel preparation regimen [Latest guidelines on bowel preparation do not provide recommendations on the appropriate dose of PEG for overweight and obese population [ | PMC10698874 |
Methods | PMC10698874 | |||
Setting and ethics | This study was a multicenter, endoscopist single-blinded RCT. This study was approved by the research ethics boards from all participating hospitals. In addition, we registered at the Chinese Clinical Trial Registry (ChiCTR2000039068). | PMC10698874 | ||
Study populations | Patients scheduled to undergo colonoscopy were selected from 7 tertiary hospitals in Sichuan Province from January to November 2021. The inclusion criteria were as follows: (1) patients who underwent colonoscopy for the first time within one month; (2) age of 18-65 years; (3) BMI ≥ 24 kg/m | PMC10698874 | ||
Bowel preparation and colonoscopy | Eligible participants were randomly assigned to the experimental group or the control group. The experimental group was given a 3 L split-dose regimen (1 L PEG was taken at 8:00 pm one day before the colonoscopy date, and 2 L PEG was taken 4-6 h before the colonoscopy). The control group was given a single dose regimen of 2 L PEG, taken 4-6 h before the colonoscopy.The laxative was PEG electrolyte powder (specification: 68.56 g/bag or 137.15 g/bag, Shenzhen Wanhe Pharmaceutical Co., LTD.), whose main component was PEG 4000. Once enrolled, each participant received a uniform education both verbally and in writing. Participants were guided to consume a low-residue diet one day before the colonoscopy (Supplementary Table | PMC10698874 | ||
Definition | The bowel preparation quality was assessed using the Boston Bowel Preparation Scale (BBPS) score [ | PMC10698874 | ||
Outcome measures | PDR, polyp, abdominal pain, dizziness, abdominal distension, nausea, | ADVERSE REACTIONS, SECONDARY, ADVERSE EVENTS | The primary outcome was the rate of adequate bowel preparation (RABP). The secondary outcomes included BBPS score; polyp detection rate (PDR); cecal intubation rate (CIR); and adverse reactions during bowel preparation, including dizziness, weakness, nausea, vomiting, abdominal pain, abdominal distension, and anal pendant expansion. Reports of adverse events were collected by telephone within two weeks after colonoscopy. | PMC10698874 |
Sample size and randomization method | WEST | Based on current research, the RABP in normal-weight people is approximately 80%, while that in people with high BMIs is less than 70%. Therefore, we assumed that the RABP for high-BMI individuals using 3 L PEG would be approximately 80%. The α value was set at 0.05, the β value was set at 0.2, and the lost to follow-up rate was set at 0.2. The sample size calculated by the professional sample size calculation tool (Medsci App 5.6.4) was 696 cases.Participants from each center were randomly and equally assigned to the 2 L and 3 L groups according to the block randomization schedule, with a block size of 4. The random number tables were independently generated by the China Evidence-based Medicine Center, West China Hospital of Sichuan University, using SAS 9.4 as the generation tool. | PMC10698874 | |
Statistical analysis | IBM SPSS 26.0 was used for statistical analysis. Qualitative data were expressed as frequencies (percentages) and were compared using Person’s χ2 test or Fisher’s exact test, as appropriate. Quantitative data were reported as the mean with standard deviation (SD), or median with interquartile range (IQR). Normally distributed quantitative data were analyzed with a T test, while nonnormally distributed quantitative data were compared using the Mann–Whitney U test. A value of P<0.05 was used for all statistical analyses. Participants were divided into subgroups based on BMI classification s[ | PMC10698874 | ||
Results | ADVERSE REACTIONS | A total of 710 patients were enrolled from January to November 2021, including 353 individuals in 3 L split dose PEG group and 357 individuals in 2 L PEG group. After enrollment, 8 and 7 individuals in the 3 L and 2 L group, respectively did not undergo colonoscopy at last. Moreover, 28 individuals in 3 L split dose PEG group, and 22 individuals in 2 L PEG group were lost to follow-up, which means we failed to ring them up. Thus, there was a lack of information about adverse reactions for those people (Fig. Study flowchart | PMC10698874 | |
Adverse reactions | ADVERSE REACTIONS, ADVERSE EVENT, ADVERSE EVENTS | 28 individuals in the 3 L group and 22 in the 2 L group were lost to follow up, without data on adverse reactions. No serious adverse events requiring medical intervention occurred in either group. As shown in Table Adverse events of bowel preparation* | PMC10698874 | |
Subgroup Analysis for adequate bowel prep | overweight | Subgroup analysis based on BMI classifications by WHO criteria showed that overweight individuals (BMI 25-29.9 kg/mExploratory subgroup analyses for adequate bowel preparation* | PMC10698874 | |
Discussion | Adequate bowel prep, overweight, colonoscopic bowel preparation, constipation | ADVERSE REACTIONS, OBESE | This multicenter randomized controlled trial study confirmed that 3 L split-dose PEG regimen was superior to 2 L PEG regimen in colonoscopic bowel preparation in relatively high-BMI individuals (BMI ≥ 24 kg/mThe optimum dose of PEG for bowel preparation before colonoscopy remains a matter of debate. A meta-analysis [Adequate bowel prep is important, and RABP is recommended to be over 85% [Although, the 3L split-dose PEG regimen performed better than the 2 L PEG regimen, 81.2% of the rate of adequacy is not enough. Whether it is better to use a 4 L regimen or change the oral preparation than a 3L regimen is currently unknown. In one previous study [The adenoma-detection rate (ADR), a quality indicator for colonoscopy, was recommended in the guidelines to be ≥ 25% [Asians generally have a smaller build, and the BMI classifications are different in the east and west. According to the Chinese standard, individuals with a BMI (24-24.9kg/mConstipation was identified as a predictor of colonoscopy preparation failure in previous research, and individuals with constipation might need more PEG [This study had several strengths. First, it was a multicenter RCT using the block randomization method. Second, the endoscopists were blinded to the bowel preparation regimen of the patients, which reduced subjective bias. However, there were still some drawbacks, for example, recall bias and the small sample size of the obese subgroup. In addition, 50 patients were lost to follow-up, we could not obtain information on adverse reactions. Moreover, there were no control subjects with normal BMI, and our subjects are not that overweight (especially BMI in the 30+ range). At last, split-dose regimen was not taken in the 2L PEG group. This prospective study can provide evidence for colonoscopic bowel preparation in relatively high-BMI individuals.In conclusion, our multicenter randomized controlled trial study confirmed that 3 L split-dose PEG regimen was superior to 2 L PEG regimen in bowel cleansing before colonoscopy in people with BMI ≥ 24 kg/m | PMC10698874 |
Acknowledgements | Not applicable. | PMC10698874 | ||
Authors’ contributions | Conception and design: Jilin Yang, and Kai Deng; acquisition of data: Hongyu, Dailan Yang, Zonghua Chen, Chao Liu, Zhong Huang, Rui Zhao, and Jing Shan; analysis and interpretation of data: Hailin Yan; drafting of the manuscript: Hailin Yan, Hongyu Huang; critical revision of the manuscript: Jilin Yang and Kai Deng; statistical analysis: Hailin Yan, Hongyu Huang; study supervision: Li Yang, Jilin Yang and Kai Deng. All authors have read and approved the manuscript. | PMC10698874 | ||
Funding | GASTROINTESTINAL CANCER | This study was supported by the Sichuan Science and Technology Program (22ZDYF1618, and 2022YFH0003), Operation Funding of Sichuan University-University of Oxford Huaxi Joint Centre for Gastrointestinal Cancer (No.161200021), and National Natural Science Foundation of China (No. 82173253). | PMC10698874 | |
Availability of data and materials | The data supporting the findings of this study are available from the corresponding author, Kai Deng, upon reasonable request. | PMC10698874 | ||
Declarations | PMC10698874 | |||
Ethics approval and consent to participate | WEST | This study was conducted in accordance with the 1964 Helsinki declaration and was approved by the Biomedical Research Ethics Committee of West China Hospital of Sichuan University. This trial was registered in the Chinese Clinical Trials Registry (ChiCTR2000039068). All patients are required to provide written informed consent. | PMC10698874 | |
Consent for publication | Not applicable. | PMC10698874 | ||
Competing interests | The authors declare no competing interests. | PMC10698874 | ||
References | PMC10698874 | |||
Significance: | deaths, tumor, death | TUMOR, TUMOR GROWTH | In translational oncology research, the patient-derived xenograft (PDX) model and its use in mouse clinical trials (MCT) are increasingly described. This involves transplanting a human tumor into a mouse and studying its evolution during follow-up or until death. A MCT contains several PDXs in which several mice are randomized to different treatment arms. Our aim was to compare longitudinal modeling of tumor growth using mixed and joint models.Mixed and joint models were compared in a real MCT (In the real dataset, of 103 deaths, 97 mice were sacrificed when reaching a predetermined tumor size (MAR data). Joint and mixed model estimates of tumor growth slopes differed significantly [0.24 (0.13;0.36)log(mmUsing a MCT example, we show that joint model can provide biased estimates under MAR mechanisms of dropout. We thus recommend to carefully choose the statistical model according to nature of mice deaths.This work brings new arguments to a controversy on the correct choice of statistical modeling methods for the analysis of MCTs. We conclude that mixed models are more robust than joint models. | PMC10035449 |
Introduction | deaths, tumor, death | REGRESSION, TUMOR, TUMOR GROWTH | In the preclinical phase of oncology drug development, various Moving beyond the classical efficacy study with PDX models to estimate antitumor efficacy for a single tumor model, there is an innovative and recent preclinical experiment design, the mouse clinical trial (MCT) or PDX Clinical Trial (Description of PDX model and MCT design. In preclinical oncology models, antitumor efficacy is usually measured by the dynamic of tumor growth in response to a defined treatment. For each PDX model, after an expansion phase, this dynamic of the subcutaneous tumor size of each mouse is measured with calipers over a given follow-up period or until the death of the mouse if this occurs before the end of the planned follow-up.How to best analyze the data collected in such MCT experiments has not clearly been resolved. In the literature, several criteria have been suggested to summarize this dynamic (Nevertheless, the most genuine approach is the analysis of quantitative tumor growth evaluated at different times during the follow-up. A simple and often used, but naïve method for the analysis of PDX data could be the comparison of tumor volume between the treatment and control groups at each evaluation time. However, this method is flawed as it does not take into account the shape of the tumor growth and the deaths of mice during follow-up. Because of deaths occurring before the end of follow-up, the evaluation of the treatment effect at late follow-up times can be biased, a well-known concept in epidemiology that is called survivor bias (subtype of selection bias). Indeed, in the presence of many deaths, the comparison between the groups based on observed data at a given timepoint is only made on mice that are still alive, that is, mice that have survived up to this timepoint (and are thus observable). These mice correspond in general to those animals with a less rapid tumor growth (Description of tumor growth evolution by subtypes and doses. The average trend (in blue) and its confidence interval (in gray) are estimated by a Loess-type regression method that ignores missing data mechanisms and within-mouse correlations.In addition, some authors (Our objective was thus to apply and contrast these two kinds of longitudinal modeling approaches of tumor growth to estimate the antitumor efficacy in the presence of early dropout due to death, with the perspective of providing recommendations on which statistical approach to favor in MCT designs. We focused on MCT designs including several biomarker subgroups because identification of subgroups with promising treatment effects is an important objective when using MCTs as a translational model towards the clinical development. | PMC10035449 |
Materials and Methods | REGRESSION, TUMOR GROWTH | Two statistical models of tumor growth based on linear mixed-effects regression model on the one hand and a joint shared random-effects model of tumor growth and survival on the other hand were used to analyze a MCT dataset. | PMC10035449 | |
MCT Study | tumor, triple-negative breast cancer, death, breast cancer | TUMOR, TRIPLE-NEGATIVE BREAST CANCER, DNA DAMAGE, BREAST CANCER | The MCT study was performed at OncoDesign. All experimental procedures were approved by the Ethics Committee of OncoDesign (C2EA; registration number 91) and were performed in full compliance with the ARRIVE guidelines, EU Directive 2010/63/ EU for animal experiments, and the 2013 French Regulatory Decree. All efforts were made to minimize animal suffering and to reduce the number of animals used (The MCT dataset was composed of 25 PDX breast cancer models provided by the IMODI French consortium (HR for hormonal receptor subgroup (ER and/or PRTNBC for triple-negative breast cancer subgroup (ERThe 63-day follow-up included an on-treatment period (with three administrations 7 days apart) and then no treatment from day 14 onward. For each mouse, tumor size was measured using calipers approximately every 3 days during follow-up.Liposomal irinotecan is a chemotherapy drug (cytotoxic agent) whose active ingredient is irinotecan (a topoisomerase I inhibitor) encapsulated in a liposome. Irinotecan and its active metabolite SN-38 inhibits topoisomerase I, a crucial enzyme in DNA replication. As a result, religation of DNA single-strand breaks is prevented, leading to exposure time-dependent, double-stranded DNA damage and cell death ( | PMC10035449 |
Statistical Modeling Strategy | tumor | TUMOR, TUMOR GROWTH | A log transformation of tumor volume was used to assume an exponential model which is often used to model tumor growth and allows to obtain a Gaussian distribution after transformation. | PMC10035449 |
Missing Data Mechanisms | deaths, death, tumor | TUMOR GROWTH, TUMOR | In MCT, the tumor growth process is stopped by death (regardless of the cause of death) which entails a dropout and missing tumor volumes. Before applying any statistical method, it is crucial to understand the nature of the missing data as statistical models are not all robust to the same type of missing data mechanism. Two different mechanisms are to be distinguished (Missing at random (MAR): occurrence of missing data is only related to observed data (in the MCT context, some sacrifices of mice are linked to an ethical threshold of tumor volume not to be exceeded (e.g., 1,500 mmMissing not at random (MNAR): occurrence of missing data is related to unobserved data (in MCT context, death due to natural causes). It is an informative study dropout.In our use case, after identifying the missing data process related to deaths, an additional analysis was performed by perturbing the initial dataset to modify the missing data process. Taking into account the observed process, the data were disrupted to have a scenario with only MNAR data by making the last TV measurements unobserved before death. This was done by considering only tumor volume measurements below a threshold that is itself below the ethical threshold. The number of deaths and date of deaths were unchanged in this dataset. The objective of these analyses was to assess the robustness of the estimates provided by the mixed and joint models in the MCT framework. | PMC10035449 |
Linear Mixed-effects Regression Model | REGRESSION | A linear mixed-effects regression model, such as recommended by authors (with Several change points were tested (3, 4, and 5 weeks post treatment initiation; These models were implemented with the package lme4 ( | PMC10035449 | |
Joint Shared Random-Effects Model | EVENT | Joint shared random-effects models (Survival model for the time of event TWith In our case with current true level with The estimation of the model parameters was done by maximum likelihood using package JM (For these two types of statistical model, the convergence and the accuracy (residuals analysis for linear mixed model part) were checked. | PMC10035449 | |
Simulations | deaths, Tumor | REGRESSION, TUMOR | A simulation study was carried out to evaluate the impact of the proportion of MAR and MNAR deaths on the estimation of the parameters of mixed and joint models. In these simulations, we assumed a single group with a 28-day follow-up with several sample size of mice (300, 200, and 100). In addition, a proportion of all-cause deaths of 50% was assumed with the following MNAR and MAR distribution scenarios: 50% MNAR and 0% MAR, 40% MNAR and 10% MAR, 30% MNAR and 20% MAR, 20% MNAR and 30% MAR, 10% MNAR and 40% MAR, 0% MNAR and 40% MAR. For each scenario, 1,000 datasets were created. Tumor growth kinetics were simulated using a single slope mixed linear regression model with random intercept and slope. MNAR deaths were simulated using R programs provided by Thomadakis and colleagues (All simulations and analyses were carried out with the R software version 4.1.0 (R Project for Statistical Computing, RRID:SCR_001905). | PMC10035449 |
Data Availability Statement | Qualified researchers may request access to study data that underlie the results reported in this publication. Additional relevant study documents, including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan and dataset specifications may also be made available. In case that patient-level data are requested, these will be anonymized, and study documents will be redacted to protect the privacy of study participants. | PMC10035449 | ||
Results | PMC10035449 | |||
Description of MCT | deaths, tumor, breast cancer | TUMOR, BREAST CANCER | The real MCT dataset was composed of 25 PDX breast cancer models with a total of 225 mice (between 1 to 18 measures per mice, 75% with at least 11 measures during follow-up) distributed by subtypes and doses as described in During the follow-up period, 103 deaths were observed and the reasons and description of deaths (sacrifice (tumor volume> ethical criteria): other reasons [natural (Description of causes of deaths by subtypes and doses. Description by cumulative incidence function.Most deaths (88%) were related to sacrifice after reaching a too large tumor size, which is characteristic of MAR data. Indeed, in this case, the deaths of mice depend on the tumor volume measurement observed at the previous time. | PMC10035449 |
Statistical Modeling Strategy | deaths, death, tumor | TUMOR GROWTH, TUMOR | Concerning the modeling strategy of the mixed model, the final model was the model with a change of slope at week 4 and random effects on the intercept and the two slopes (The estimates of the treatment effect by subtypes and doses with three different models (piecewise linear mixed model with one-level random effects, piecewise linear mixed model with two-level random effects and joint model with one-level random effects) are summarized in Estimation of treatment effect on tumor growth (log(mmAlthough it is preferable to take into account all levels of correlation (PDX and mouse), mixed models taking into account only the mouse level correlation (one-level, AIC: 1606.1) gave very similar results to mixed models including also the PDX level correlation (two-level, AIC: 1458.7).The estimates obtained by joint model under the assumption of MNAR dropout due to death differed substantially from those obtained by the mixed models under the assumption of MAR dropout, especially in the second period when the number of deaths was increasing (Furthermore, to confirm that this difference in estimation between the mixed model and the joint model is due to the nature of the deaths, a complementary analysis was performed by perturbating the MAR data process. In the case of MCT and a MAR missing data process on tumor growth, this process can become MNAR by artificially rendering unobserved the tumor values that gave rise to the sacrifice (considering only the tumor volume measurements at an earlier stage than the ethical threshold, 900 mm | PMC10035449 |
Results of the Simulation Study | deaths | The simulation study showed that, whatever the sample size and the proportion of MAR and MNAR deaths, the mixed model converged more often than the joint model (Estimation of treatment effect (slope) by mixed and joint models of the simulation study
| PMC10035449 | |
Discussion | deaths, death, tumor | REGRESSION, TUMOR GROWTH, TUMOR | In MCTs, antitumor efficacy is evaluated by modeling tumor growth using statistical models for longitudinal data. These models must handle the early dropout induced by the death of mice to avoid survivor bias in analyses over time. Using an example of a MCT with a high rate of dropout due to death during the follow-up, as well as a simulation study, we compared the results of two statistical modeling methods, mixed models and joint models, described in the literature for the analysis of this type of data. We showed, with the analysis of the real dataset and the associated complementary analysis, that the joint model can lead to biased estimates of the antitumor efficacy of a treatment in the presence of a high proportion of dropouts that were explained by the observations, that is MAR. Moreover, the additional simulation study confirmed that the bias is due to the presence of the MAR missing dropout mechanism and showed that this bias is all the higher in the presence of competing dropout mechanisms MAR and MNAR. This problem has previously been identified, in an Human Immunodeficiency Virus (HIV) context, in simulation studies in the presence of different study dropout mechanisms (MAR, MNAR and competing dropout mechanisms MAR and MNAR with a predominance of MAR dropouts; refs. Joint models including observations to predict death in addition to the current level of biomarker (in our use case tumor volume) have been developed to tackle this problem of biased estimation for MAR situations (In the context of MCT analysis, it is therefore important to record the reasons for dropouts and especially the causes of death, to inform the choice of the statistical model to be used for the analysis of this type of data in particular with many dropouts. In the context of many dropouts due to mouse sacrifices related to too large and therefore unethical tumor size, we recommend using linear mixed models. Furthermore, in the case where in each treatment arm there are several mice from the same PDX [MCT setting as opposed to the single mouse trial (1 mouse per PDX in each treatment arm)], we recommend the use of nested random effects linear mixed models.For the additional analysis, we created a database containing only MNAR study dropouts by making the tumor growth measurements leading to death unobservable. An alternative would have been to create a database with MNAR study dropouts by randomly drawing MNAR study dropouts from the original dataset. However, in the original database, given the low number of deaths leading to MNAR study dropouts (For our analyses, we assumed an exponential tumor growth by applying a logarithmic transformation to the data. We have shown that within our framework of the statistical regression model with change in slopes, there was a good fit of the model to the data under this assumption. However, it should be noted that other more complex forms of tumor growth and/or more complex treatment effects could be estimated using mechanistic models (In conclusion, the joint models are often recommended in the literature to deal with informative (MNAR) or noninformative (MAR) study dropout. However, these models are valid only under the assumption of a correct specification of the study dropout mechanism. Here we illustrate that this methodology can provide biased estimates under certain MAR study dropout mechanisms and under competitive risk of MAR and MNAR study dropouts. We recommend that a linear mixed model is preferred for MCT analyses. | PMC10035449 |
Supplementary Material | tumor growths | REGRESSION, TUMOR GROWTH | Definition of summary measures of tumor growths used MCT endpoints in the literature.Click here for additional data file.Details on statistical modeling strategy.Click here for additional data file.Linear mixed-effects regression modelClick here for additional data file.Residuals analysis of joint shared random effect model.Click here for additional data file. | PMC10035449 |
Acknowledgment | This study was sponsored by Ipsen.
| PMC10035449 | ||
Authors’ Disclosures | H. Savel reports other from Ipsen during the conduct of the study; other from Ipsen outside the submitted work. F. Meyer-Losic reports other from Ipsen during the conduct of the study. L. Richert reports grants from Ipsen during the conduct of the study. No disclosures were reported by the other authors. | PMC10035449 | ||
Authors’ Contributions | PMC10035449 | |||
References | PMC10035449 | |||
Key Points | PMC10436133 | |||
Question | anxiety | Does a preoperative walkthrough of a patient’s day of surgery using augmented reality (AR) effect the patient’s anxiety levels? | PMC10436133 | |
Findings | Anxiety | In this randomized clinical trial that included 95 patients, patients who received the preoperative AR experienced a significant decrease in preoperative State-Trait Anxiety Inventory (STAI) score compared with the control group that received standard education materials. There was no significant difference in STAI scores after operations. | PMC10436133 | |
Meaning | anxiety | These findings suggest that a preoperative AR walkthrough may be a useful tool for reducing preoperative anxiety, but its impact on postoperative anxiety is less clear.This randomized clinical trial assesses whether the use of an augmented reality walkthrough of the day of surgery reduces patient perioperative anxiety compared with a standard educational control. | PMC10436133 | |
Importance | anxiety | Both augmented reality (AR) and virtual reality (VR) have had increasing applications in medicine, including medical training, psychology, physical medicine, rehabilitation, and surgical specialties, such as neurosurgery and orthopedic surgery. There are little data on AR’s effect on patients’ anxiety and experiences. | PMC10436133 | |
Objective | anxiety | To determine whether the use of an AR walkthrough effects patient perioperative anxiety. | PMC10436133 | |
Design, Setting, and Participants | This randomized clinical trial was conducted at an outpatient surgery center in 2021 to 2022. All patients undergoing elective orthopedic surgery with the senior author were randomized to the treatment or control group. Analyses were conducted per protocol. Data analysis was performed in November 2022. | PMC10436133 | ||
Intervention | AR experience explaining to patients what to expect on their day of surgery and walking them through the surgery space. The control group received the standard educational packet. | PMC10436133 | ||
Main Outcomes and Measures | Anxiety | The main outcome was change in State-Trait Anxiety Inventory (STAI) from the screening survey to the preoperative survey. | PMC10436133 | |
Results | anxiety | A total of 140 patients were eligible, and 45 patients either declined or were excluded. Therefore, 95 patients (63 [66.3%] male; mean [SD] age, 38 [16] years) were recruited for the study and included in the final analysis; 46 patients received the AR intervention, and 49 patients received standard instructions. The AR group experienced a decrease in anxiety from the screening to preoperative survey (mean score change, −2.4 [95% CI, −4.6 to −0.3]), while the standard care group experienced an increase (mean score change, 2.6 [95% CI, 0.2 to 4.9]; | PMC10436133 | |
Conclusions and Relevance | pain, anxiety, postoperative anxiety | In this randomized clinical trial, the use of AR decreased preoperative anxiety compared with traditional perioperative education and handouts, but there was no significant effect on postoperative anxiety, pain levels, or narcotic use. These findings suggest that AR may serve as an effective means of decreasing preoperative patient anxiety. | PMC10436133 | |
Trial Registration | ClinicalTrials.gov Identifier: | PMC10436133 | ||
Introduction | Anxiety, anxiety | Anxiety experienced by patients before a surgical intervention is a well-documented phenomenon, occurring in up to 60% to 80% of patients, and it can lead to alterations in cognitive and physiologic function.There is strong evidence that preoperative educational interventions can reduce patient perioperative anxiety.Advances in the preparation and delivery of patient care and education have begun to incorporate augmented reality (AR) and virtual reality (VR). AR has been defined as the superimposition of interactable virtual objects onto a physical environment in space.AR and VR have shown therapeutic benefits in psychology,While AR and VR have been used to improve patient education about the specifics of their procedure, to our knowledge, no studies have been performed that examine AR’s ability to affect patient anxiety and experience in the outpatient surgical setting by providing the patient a step-by-step walkthrough of their day of surgery. We hypothesize that by applying the AR to perioperative patient education and experience, we can decrease perioperative patient anxiety and improve patient experience and satisfaction. | PMC10436133 |
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