Fear Of Relapse Research Articles

Patients' Experiences of Health After Surgical Treatment for Paraesophageal Hernia Grades III and IV: An Interview Based Study.

Surgery is the only available treatment for the longstanding chronic symptoms associated with large paraesophageal hernias except for reflux disease. The aim of this study was to illuminate how patients who previously suffered from grade III-IV hiatal hernia experience their life and health 2-6months after surgery. The study is based on semi-structured interviews with 17 patients who received elective laparoscopic hernia repair for a large paraesophageal hernia. The data were analyzed using qualitative content analysis, resulting in three main themes: "Experiences of health," "Being unable to leave the disease behind," and "Still feeling unwell" and seven subthemes: "Escaping suffering"; "Learning to interpret bodily signals"; "Looking to the future with confidence"; "Finding oneself in a vicious circle of worry"; "The fear of relapse as a constant companion"; "Lingering disabling symptoms," and "New and frightening symptoms." Our study demonstrates large individual variations in the way patients experience their life and health after laparoscopic hernia repair. Central to the patients' descriptions is that simply feeling physically healthy is insufficient for achieving overall health. Health care personnel can benefit from learning about patients' experiences of health and suffering after surgery.

#1030 Addressing the unmet need of patient reported outcomes in ANCA associated vasculitis, in routine clinical practice

Abstract Background and Aims ANCA associated vasculitis (AAV) is associated with increased morbidity. Recent years has seen improvement in clinical outcomes yet little work has been done to better understand the patient's role within this condition. Patient reported outcome measures (PROMs) are increasingly standard in clinical research outcomes, as well as an overall indicator for good quality patient care. With the exception of Robson et al AAV-PRO [1], little research has been done to develop validated disease specific tools for patients living with AAV. We aim to develop a disease specific tool that can be used in clinical practice to aid patients and clinicians in understanding and track changes in health-related quality of life (HRQoL) over time. Method AAV patients from a single centre were invited to take part in focus groups conducted using a semi-structured topic guide. Participants were asked to discuss topics relating to four broad areas; 1) the effects of AAV on everyday life and living, 2) the effects of treatment on everyday life and living, 3) the role of patients in health management and the patient experience 4) a review of existing generic and disease specific PROM tools (SF-36 and AAV-PRO). Audio transcript of each focus group was transcribed verbatim and data was analysed using a combination of inductive and deductive framework analysis [2]. Results Twenty-eight patients with AAV were invited to participate, 19 attended one of three, 2.5 hour focus groups, 2 patients failed to attend, 4 declined and 3 were unavailable. The mean age of participants was 66.6 +9.4 years and there was a near equal male to female split (10:9). The median time from diagnosis as 7.4 years. Three participants had active or newly diagnosed AAV with BVAS scores of >10. Five participants had previously required dialysis with 1 receiving a renal transplant. All participants received glucocorticoid and immunosuppressive therapy (cyclophosphamide and or Rituximab), 15 (78.9%) were still receiving immunotherapy. Full analysis of the qualitative data is being undertaken. Preliminary findings outlined what was most important to participants when considering HRQoL. Areas acknowledged included; self-identity, social roles e.g. fulfilling caring responsibilities, fears of relapse and disease and treatment burden. Fifty-six deductive and inductive codes were identified which have been further categorised. Participants felt existing tools lacked consideration of some key issues. Scoring systems were considered to be negativity worded e.g. mild, moderate, severe, with the term ‘none’ being the only positive option. Participants reported that existing tools overlooked positive factors which impact HRQoL, such as symptom validation, close clinician monitoring and improvement with treatment. Limitations were noted when trying to address transient or inconsistent symptoms and difficulty separating vasculitis from other health conditions when answering questions. Participants expressed a preference for using a PROM as part of their clinical care and felt that completing it prior to clinic would be most helpful and facilitate discussions with healthcare professionals. The use of an electronic-PROM was widely supported and would support clinicians and patients to monitor changes over time. Conclusion The AAV-PRO represents a significant advancement over generic tools such as the SF-36, however, existing PROMs are not without limitations and are primarily used in research practices. Our study revealed that patients desire active participation in HRQoL discussions and further work to incorporate this into the clinic setting is needed. We are continuing to develop a PROM tool that can be used to assess patients HRQoL in relation to their AAV in the outpatient setting. We believe this will allow a deeper understanding of the disease burden and could support a comprehensive, patient-centred approach to decision-making, offering new insights and identifying the need for supportive care. On a broader scale, these insights can be utilized to compare treatments, shed light on inequalities and facilitate enhancements in services.

Validation of the Return-to-Work Obstacles and Self-Efficacy Scale for Women on Sick Leave Due to Breast Cancer (ROSES-BC).

Breast cancer (BC) is the most frequently diagnosed cancer among women. Approximately 40% of BC survivors are diagnosed during the peak years of their professional career. Women face numerous obstacles when returning to work (RTW) after BC. Their decision-making process and self-efficacy to overcome these barriers may undergo alterations. The objective of this study was to validate the Return-to-work Obstacles and Self-Efficacy Scale (ROSES) for BC survivors, with a focus on three psychometric properties: construct validity, test-retest reliability, and predictive validity. This prospective study consists of three phases: Phase 1 (baseline, during sick leave) was conducted to evaluate construct validity, Phase 2 (2 weeks later) assessed test-retest reliability, and Phase 3 (6-month follow-up, RTW or not) aimed to evaluate predictive validity. A total of 153 BC survivors participated in Phase 1 of the study, where they completed the 10 dimensions of the ROSES (e.g., fear of relapse, cognitive difficulties). Confirmatory factor analyses (CFA), Pearson correlations, and Cox regressions were performed, with respect to each phase. The mean duration for RTW with the same employer was 62.7 weeks. CFAs confirmed the ROSES structure, which had previously been established for other health conditions, showing satisfactory coefficients. Significant Pearson correlation coefficients were observed between the ROSES dimensions from Phase 1 to Phase 2, ranging from 0.66 to 0.88. When considering various confounding variables, chemotherapy treatment and cognitive difficulties (ROSES dimension) emerged as the only significant predictors of RTW. These findings support the utilization of the ROSES in clinical and research settings for BC survivors to improve their successful RTW. After an initial screening using the ROSES, occupational health professionals can further conduct a focused and thorough evaluation of specific dimensions, such as cognitive difficulties. Additional research and information are required to assist BC survivors in dealing with cognitive impairments induced by chemotherapy when they return to work.

Everyday Life Six to Eight Months After Esophagectomy for Cancer: A Qualitative Study.

This study sought to explore the life situation of male patients at a critical stage after surgery for esophageal cancer and to enlighten their need for support from healthcare providers during their return to daily life. In-depth and semi-structured interviews were conducted with six patients following surgery for esophageal cancer. The interview data were analyzed via inductive thematic analysis. The patient quality of life was seriously impacted by their remaining symptoms six to eight months after surgery. Challenges associated with eating and uncontrolled diarrhea were reported to be the most demanding symptoms, limiting social activities and hindering the patients' attempts to resume their former identity. In many cases, the patients were dependent on their spouses with regard to the activities of daily life. Being surgically treated for a cancer with a potentially poor prognosis was experienced as akin to living in limbo. Uncertainty regarding their future health posed challenges for the patients in terms of their vocational life and general life planning. Patients may require additional support in coping with their new life situation following surgery for esophageal cancer. The heavy burden on a patient spouse should also be recognized from the time of hospital discharge. Moreover, patients may benefit from closer follow-up by healthcare providers, including support groups to help cope with insecurity and fear of relapse.

Patient Perceived Barriers and Enablers to Medication Adherence in the Treatment of Depression: A Qualitative Study.

Depression affects approximately 280 million individuals globally and it is a leading cause of disability. Despite effective medication options, 50% of patients prematurely discontinue antidepressants within 6 months. We sought to understand patients' perspectives regarding their needs and expectations related to antidepressants. To identify and describe enablers and barriers that influence adult patients' medication adherence in depression treatment and to explore patients' educational needs on initiating or continuing antidepressant therapy. Qualitative descriptive study was conducted using individual, semi-structured interviews of adult patients with depression who were prescribed an antidepressant within 3 months of study recruitment at an urban primary care clinic in Toronto, Canada. Thirteen participants were interviewed. Interviews were recorded and transcribed verbatim for inductive thematic analysis. Six themes emerged: safety and effectiveness of antidepressant, understanding of depression and its management, medication administration, healthcare experiences in the treatment of depression, and social influences and relationships. Barriers to adherence included adverse effects of antidepressants, preference for non-pharmacological therapies, uncertainty about therapeutic effects, and social stigma. In contrast, enablers were positive responses from antidepressants, fear of relapse, reminder aids, established routine, and a trusting patient-provider relationship. Participants desired access to reliable, evidence-based, and personalized educational information delivered through verbal, written, and digital formats to support antidepressant adherence. To overcome the identified barriers, educational strategies should involve both patients and their prescribers to identify patient-specific needs and treatment goals, engage in shared decision-making, and maintain consistent follow-up to support antidepressant adherence.

ANXIETY AND COPING IN SCHOOL-AGED CHILDREN DURING CHEMOTHERAPY TREATMENT

Cancer was a chronic disease that increased child mortality. Treatment processes and drug side effects, fear of relapse, frequent re-entry, and death, functional impairment, changes in body image, decreased self-esteem, and challenges in transitioning back to life caused considerable stress and anxiety for pediatric cancer patients. Almost all pediatric cancer patients were faced with at least one psychosocial problem, of which anxiety and depression often coexisted and were most frequently reported. Anxiety and coping affected the quality of life of children with cancer. This research aimed to identify anxiety and coping in school-age children during chemotherapy treatment. This research used a quantitative descriptive method. Forty-five children participated in this research. The research instrument used for data collection was anxiety and coping questionnaires. Data were analyzed using descriptive analysis. The result of this research showed that the majority of school-age children's anxiety during chemotherapy programs was in the moderate anxiety category, while the majority of children's coping was in the maladaptive coping category. Anxiety and coping were factors that affected the quality of life of children with cancer. Further research is expected to examine interventions that can improve adaptive coping in children undergoing chemotherapy.Keywords: anxiety, coping, chemotherapy, school-age children

Designing an intervention to help the quitters quit: A qualitative, intervention co-design study.

E-cigarettes are increasingly being provided by publicly funded stop smoking services. Our objectives were to understand the challenges and establish the means by which services could best support the use and subsequent discontinuation of e-cigarettes for this purpose. Semi-structured interviews and co-design workshops with service users and providers of a stop smoking service. Thematic analysis was conducted. Interviews identified: 1. a reluctance to use e-cigarettes for cessation, 2. struggle to quit e-cigarettes (dependency, fear of relapse, compensatory "puffing") and 3. service development needs (consistency of approach). Co-design workshops suggested: 1. facilitation of e-cigarette use through understanding previous failed attempts, 2. offering a longer, two-staged approach to tobacco then e-cigarette cessation, careful timing of behavioural strategies and 3. enhanced communication between providers. Our study suggests additional modifications to smoking cessation support measures when e-cigarettes are used for smoking cessation to address the challenges posed by public health guidance: "smokers should switch to vaping and vapers should stop smoking completely". Our study is the first to consider experiences of service users and providers about the challenges of using e-cigarettes for cessation; our co-design group of providers informed nine strategies needed to support this approach in practice.

The Lack of Tolerable Treatments Options That Can Induce Durable Responses without Fear of Relapse after Discontinuation Represents a Significant Unmet Need for Patients (Pts) with Immune Thrombocytopenia (ITP): Results from the ITP World Impact Survey (I-WISh) 2.0

Background: ITP is an acquired autoimmune disease characterized by transient or persistent thrombocytopenia. ITP substantially impairs pts' quality of life (QoL), including daily activities, social interactions, work and emotional wellbeing, with fatigue being the most common symptom reported by pts. Corticosteroids are the standard first-line treatment for ITP, while thrombopoietin receptor agonists (TPO-RAs), rituximab and fostamatinib are recommended for later lines; however, these treatments have limited sustained efficacy and may be associated with short- and long-term side effects that impact QoL. Aim: To assess pt and physician (MD) perceptions of current ITP treatment and treatment goals using data from I-WISh 2.0. Methods: I-WISh 2.0 was developed using findings from I-WISh 1.0 and surveyed 1018 pts with ITP aged >18 years and 431 MDs who managed ≥3 pts with ITP. I-WISh 2.0 was conducted from February to July 2022 in 15 countries. The surveys, developed by a steering committee (supported by Novartis) comprising expert ITP MDs and pt advocates, included questionnaires about prescribed ITP treatments, their impact on QoL and treatment satisfaction and goals. Results: Of 1018 pts (median age: 46 years), 67% were female and 48% reported ≥1 comorbidity. 97% (956/987) of pts had received ≥1 treatment for ITP and 12% (126/1018) had a splenectomy; 80% (811/1018) were receiving ITP treatment at survey completion and median time on most recent treatment was 30 weeks (n=608). Corticosteroids and TPO-RAs were the most common first- and second-line treatments prescribed by MDs, respectively (Figure 1); MDs estimated that 15% of their pts have opted against receiving ITP treatment (n=431). 73% of MDs (313/431) considered their pts' perception of medications when making treatment decisions. Pts reported a significant burden due to their current ITP medication: 34% (202/597) experienced daily disruption, 37% (214/576) were bothered by needing to plan meals, and 22% (204/939) had difficulty keeping up with daily medications. 19% (172/897) of pts were dissatisfied with their treatment's platelet level control, and 18% (155/843) disagreed that their medication effectively controlled their symptoms. Pts worried about their treatment's short- (48%; 400/833) and long-term (62%; 527/844) side effects. 38% (162/431) of MDs were neutral toward current ITP treatment options and 9% (37/431) were dissatisfied. Of the 37 dissatisfied MDs, limited options (68%), inability to achieve deep/stable remission (54%), lack of efficacy (43%) and inability to reach treatment goals (43%) were the most common reasons. 32% (327/1016) and 13% (127/1016) of pts believed they were not or did not know if they were in sustained remission, respectively. A treatment offering a sustained remission or cure for ITP was an important goal for 82% (823/1007) of pts. Of treatment goals mentioned in their top 3, the most common were healthy blood counts (56%), improving QoL (44%) and increasing energy levels (43%) for pts (n=1018), and reducing spontaneous bleeds (79%), healthy blood counts (60%) and improving QoL (52%) for MDs (n=431). Limiting time on treatment would substantially affect the treatment preference of 66% (668/1009) of pts. 38% (294/775) of pts did not want to take their ITP treatment for the foreseeable future; however, 67% (680/1013) were concerned about relapse if they stopped. Immunosuppression due to ITP treatment worried 414/787 (53%) pts, with 679/1007 (67%) considering it important when discussing treatment decisions. MDs considered corticosteroids and other immunosuppressants to have the most negative impact on fatigue (Figure 2), yet only 12% (52/431) strongly agreed they aimed to limit immunosuppressive effects. Conclusions: Pts with ITP are dissatisfied with current treatment options because of a perceived lack of efficacy, the burden of short- and long-term side effects, and the need for daily, life-long administration. Additionally, some commonly prescribed treatments for ITP are associated with fatigue. Pts and MDs would like new ITP treatments to offer a sustained period of remission or cure, and pts wish to be able to discontinue them without fear of relapse. There is an unmet need for well-tolerated therapies with disease-modifying potential that can safely achieve these goals.

Evaluation of orthodontic retention and retainer content on the Reddit social media website.

Social media can provide insight into patient experiences with health care. The aim of this study was to evaluate the content regarding orthodontic retention and retainers on the social media website, Reddit. A systematic search for relevant content submitted over a 12-month period on the Reddit forum, r/braces, was conducted. Qualitative analysis of the initial posts for themes and subthemes was conducted by two investigators. Responding comments to the initial posts were assessed for supportiveness for each initial poster and alignment with the evidence-base. Quantitative assessment was via descriptive statistics. A total of 271 initial posts and 984 comments satisfied the inclusion/exclusion criteria. All initial posts were by patients. Just 1.12% (n=11) of the comments appeared to be provided by oral health professionals. Most initial posts were negative (50.18%; n=136), and most comments were positive (70.42%; n=693). Alignment with the evidence-base was high among the comments (67.89%; n=668). Eight main themes were identified with concerns regarding the negative impact of retention and retainers on quality of life, compliance with retention protocols and relapse commonly expressed. Concern regarding fear of relapse when waiting for the initial or renewal of retainers was a novel finding. More negative sentiments about orthodontists were expressed than positive. Reddit is a supportive and reliable environment for patients regarding orthodontic retention and retainers. The content evaluation suggested deficiencies in communication processes between clinicians and patients. Greater engagement of the orthodontic profession in the provision of supportive and evidence-based information on an individual patient basis and through appropriate information channels is required.

Fear of relapse and quality of life in multiple sclerosis: The mediating role of psychological resilience

The goal of this study was to examine the mediating role of psychological resilience in the relationship between fear of relapse and quality of life in a sample of patients with multiple sclerosis (PwMS). This cross-sectional study was developed online. A total of 240 PwMS were surveyed using the Multiple Sclerosis Quality of Life inventory, the Fear of Relapse Scale and the Connor-Davidson Resilience Scale. To perform the mediation analysis PROCESS macro was used. In our study, fear of relapse was a predictor of psychological resilience and quality of life, and psychological resilience was a predictor of quality of life. Finally, psychological resilience showed a mediating role in the relationship between fear of relapse and quality of life. Considering that resilience is a modifiable variable, the implementation of interventions aimed at enhancing resilience can have a favorable impact on the psychological well-being and quality of life of patients with multiple sclerosis.

Quality of life after pancreatoduodenectomy: Is the outcome predetermined by the diagnosis?

Non-physiological factors tied to the disease process may drive the diminished quality of life (QoL) after pancreatoduodenectomy (PD). We compared postoperative QoL among patients undergoing PD for either benign or malignant pathology. From 2012 to 2021, 228 patients underwent PD in a large healthcare system. Eighty-two patients (36.0%) were interviewed using the EORTC QLQ-C30 questionnaire. A minimum of 6 months after surgery was required for the survey. QoL outcomes were compared based on diagnosis (benign vs. malignant). Patient mean age was 65 years (21-82), and forty-seven (57%) were men. Most patients underwent surgery for cancer, 76% (n = 62). Grade B postoperative pancreatic fistula incidence was higher in benign cases (30% vs. 6.5%, p = 0.024). Weight loss was more common in malignancy (79% vs. 50%, p = 0.016). Carcinoma patients felt less useful, hopeful, reported less control of their life and certainty of the future, and were less satisfied with their appearance. Carcinoma patients also reported diminished memory, fear of relapse, and greater financial burden. Long-term QoL is inferior in PD patients with carcinoma and is driven by the psychological and socioeconomic implications of malignancy. Supportive resources for pancreas cancer patients should be evaluated and optimized.

Fear of re-infection, relapse, and anxiety during COVID-19 pandemic in patients with multiple sclerosis: A multi-center study.

Background: Fear of relapse and re-infection during the coronavirus disease 2019 (COVID-19) pandemic can affect people with chronic relapsing diseases, such as multiple sclerosis (MS). We evaluated fear of re-infection, anxiety, and relapse during the COVID-19 pandemic in Iranian people with MS. Methods: This multicenter, cross-sectional study was performed in the MS clinic of Sina Hospital, Tehran, Iran, and Hakim Private Hospital, Isfahan, Iran, between January and April 2022. We asked the participants to fill out validated Persian versions of Fear of Relapse Scale (FoR), and Beck Anxiety Inventory (BAI) questionnaires and answer a binary question about their fear of getting reinfected with COVID-19. Results were reported as mean ± standard deviation (SD) for continuous variables or frequencies for categorical variables. For continuous variables which did not have a normal distribution, we reported the median and interquartile range (IQR). Spearman correlation coefficient between anxiety score and FoR score was calculated. An independent samples t-test was used to compare continuous variables. Results: Three hundred and sixty-eight patients participated in this study. The median scores of FoR and BAI were 49.7 and 34.3, respectively. Fifty-three had new relapses in their last infection. Thirty-six percent of the patients had a fear of getting COVID-19 again, and 43% had a fear of relapse during infection. Three hundred and twenty-three had two doses of COVID-19 vaccine; the most frequent type of vaccine was Sinopharm. There was a significant difference between the median FoR scores among patients with and without relapse during the last COVID-19. There was also a significant positive correlation between anxiety score and FoR (r = 0.49, P < 0.001). Conclusion: More than one-third of enrolled cases had fear of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) re-infection. Patients who experienced exacerbation of symptoms even in the form of relapse or pseudo relapse (possible clinical relapse) had a higher fear of infection.

Immunological factor development of external genital endometriosis

External genital endometriosis (EGE) is one of the common gynecological diseases of women of reproductive age with a relapsing, progressive course that worsens the quality of life of patients due to pain, emotional imbalance, fear of relapse and possible surgical intervention. Currently, endometriosis is recognized as one of the most common diseases associated with infertility. Thus, among fertile women with preserved childbearing function, the disease is generally diagnosed in approximately 6-7%, while among patients suffering from infertility, its frequency can reach 20-48%.However, the causes that determine reproductive dysfunction in patients with EGE are not well understood. Much attention is currently paid to the role of immunity in the formation of endometriosis. Patients with EGE show changes in both local immunity factors and immunological components of circulating blood.Purpose of the study: the study of factors of innate and adaptive immunity in patients of reproductive age with external genital endometriosis (EGE).The study included 71 patients with various stages of external genital endometriosis, the control group included 24 patients without endometriosis. Determination of the population composition of peripheral blood lymphocytes, the level of monocytes expressing TLR, activation markers, was carried out by laser flow cytometry — Immunotex (France), Caltag (USA), FITC (fluorescein isothiocynate) — labeled CD3, CD4, CD8, CD16, CD19, HLA-DR, CD282, CD284 and PE (phycoerythrin) - labeled with CD25, CD69, CD95, CD107a, CD14.External genital endometriosis is characterized by: at stages I-II of the disease - a violation of the early stages of the innate immune response (an increase in the number of monocytes expressing TLR-4, a violation of the activation and differentiation processes of immunocompetent cells, which is reflected in a decrease in the expression of CD16, CD8, CD16+HLA-DR+, CD16+CD107a+, CD8+CD107a+, at III-IV stages of the disease, there is a decrease in the level of CD16 and activation markers CD69, HLA-DR, CD107a on their surface, which is combined with a decrease in the expression of CD8, CD16, HLADR and CD107a on their surface. CD95+ and CD8+CD95+ were found at various stages of EGE.The results obtained allow us to understand the features of the functioning of innate and adaptive immunity at various stages of external genital endometriosis, and the studied immunological parameters can be used as diagnostic criteria for the formation of various stages of EGE. These data can serve as a theoretical basis for further identification of markers of EGE progression, as well as the mechanisms underlying immune inflammation.

The Importance of Patient-Focused Drug Development in Pemphigus and Pemphigoid

The Importance of Patient-Focused Drug Development in Pemphigus and Pemphigoid

A non-inferiority randomized phase III trial of standard immunotherapy by checkpoint inhibitors vs. reduced dose intensity in responding patients with metastatic cancer: the MOIO protocol study

BackgroundImmunotherapy (IO) has become a standard of care for treating various types of metastatic cancers and has significantly improved clinical outcome. With the exception of metastatic melanoma in complete response for which treatment can be stopped at 6 months, these treatments are currently administered until either disease progression for some IO, 2 years for others, or unacceptable toxicity. However, a growing number of studies are reporting maintenance of response despite discontinuation of therapy. There is currently no evidence of a dose effect of IO in pharmacokinetic studies. Maintaining efficacy despite a reduction in treatment intensity by decreasing the frequency of administration in patients with highly selected metastatic cancer, is the hypothesis evaluated in the MOIO study.Method/designThis non-inferiority, randomized phase III study aims to compare the standard regimen to a 3 monthly regimen of variousIO drugs in adult patients with metastatic cancer in partial (PR) or complete response (CR) after 6 months of standard IO dosing (except melanoma in CR). This is a French national study conducted in 36 centers. The main objective is to demonstrate that the efficacy of a three-monthly administration is not unacceptably less efficacious than a standard administration. Secondary objectives are cost-effectiveness, quality of life (QOL), anxiety, fear of relapse, response rate, overall survival and toxicity.After 6 months of standard IO, patients with partial or complete response will be randomized 1:1 between standard IO or a reduced intensity dose of IO, administered every 3 months. The randomization will be stratified on therapy line,, tumor type, IO type and response status. The primary endpoint is the hazard ratio of progression-free survival. With a planned study duration of 6 years, including 36 months enrolment time, 646 patients are planned to demonstrate with a statistical level of evidence of 5% that the reduced IO regimen is non-inferior to the standard IO regimen, with a relative non-inferiority margin set at 1.3.DiscussionShould the hypothesis of non-inferiority with an IO reduced dose intensity be validated, alternate scheduling could preserve efficacy while being cost-effective and allowing a reduction of the toxicity, with an increase in patient’s QOL.Trial registrationNCT05078047.

The impact of necrotizing soft tissue infections on the lives of survivors: a qualitative study

PurposeNecrotizing soft tissue infections (NSTI) are potentially lethal infections marked by local tissue destruction and systemic sepsis, which require aggressive treatment. Survivors often face a long recovery trajectory. This study was initiated to increase understanding of the long-term impact of NSTI on health related quality of life (HRQoL), and how care may be improved.MethodsThematic analysis was applied to qualitative data from 25 NSTI-survivors obtained through two focus groups (n = 14) and semi-structured interviews (n = 11).ResultsThe median age of the participants was 49 years, 14 were female. The median time since diagnosis was 5 years. Initial misdiagnosis was common, causing delay to treatment. Survivors experienced long-term physical consequences (scarring, cognitive impairment, fatigue, sleeping problems, recurrent infections), psychological consequences (traumatic stress symptoms, fear of relapse, adjusting to an altered appearance, sexual issues) and social and relational consequences (changes in social contacts, a lack of understanding). The disease also had a major psychological impact on family members, as well as major financial impact in some. There was a strong desire to reflect on ‘mistakes’ in case of initial misdiagnosis. To improve care, patient and family centered care, smooth transitions after discharge, and the availability of understandable information were deemed important.ConclusionThis study reveals that NSTI have a large impact on physical and psychosocial wellbeing of survivors and their relatives. Except for a few differences (misdiagnosis, fear for re-infection and actual re-infection), the patient experience of patients with NSTI is largely similar to those of burn survivors. Thus, questionnaires to assess HRQoL in burn survivors may be used in future NSTI studies.

Brains on Fire: Patient Outcomes and Quality of Life Following Autoimmune Encephalitis

Objective To present and improve understanding of patient outcomes and quality of life post-autoimmune encephalitis. Background Patient outcome following encephalitis and in particular following autoimmune encephalitis is not well understood. It is only over the last 15 years that we knew, became able to test for, and identify some of these autoimmune causes of encephalitis and so there currently only a small and emerging literature about patient outcomes. Many papers that talk about or refer to patient outcome look quite early on in the patient pathway and often when they talk about outcome they mean immediate clinical outcome and not how patients are, if they survive, several months or years down the line. Therefore we don't actually have a good handle yet on autoimmune patient outcomes nor their quality of life. Yet, most papers agree that much more needs to be done to assess long-term outcome and quality of life in autoimmune encephalitis patients. One further point of importance is that some complications of AE might not appear until several months or years down the line. Design/Methods Review of the literature accompanied by first-hand patient video testimony providing rich insight into long term outcomes and impact on quality of life post-autoimmune encephalitis. Results Patient outcomes post-AE can be life-changing and in some instances may occur several months and years post-acute illness. These outcomes and quality of life influence how patients understand and make sense of their experience; how they engage with recovery and rehabilitation. A range of poorly understood factors influence patient quality of life post-AE. These include a lack of easily understood index event, lack of community and collective understanding, fears of relapse, post-ICU PTSD, and a lack of accurate information and understanding of their outcomes pre and post-discharge. Conclusions Improved understanding of patient outcomes post autoimmune encephalitis can improve patient care and engagement.

The importance of physical assessment in post-mastectomy rehabilitation

Abstract Introduction. The application of surgical, oncological and hormonal treatment causes the appearance of various dysfunctions at the somatic level: decreased joint mobility and muscle strength, lymphedema, pain, peripheral neuropathy, cardiovascular and gastrocecal conditions, and at the psychological level: insomnia, fear of relapse, anxiety and depression. Aim of the study. This study highlights the main methods of evaluating the sequelae of breast cancer treatment, which are of particular importance in physical recovery. As well, we want to spotlight the main physical activities that can be performed. Methods. In order to identify the adverse effects of the treatment as well as their assessment methods, we studied the national and international specialized literature. Results. The physical assessment of patients after mastectomy includes: assessment of functional level, manual muscle testing, active range of motion, evaluation of lymphedema, quality of life and pain assessment. Conclusions. Evaluation in physical therapy is of particular importance because it helps to create an appropriate recovery protocol, but also to appreciate the evolution of patients and the efficiency of the applied program.

'Trying to catch up with life': The expectations and views of adolescent survivors of childhood acute lymphoblastic leukaemia about long-term follow-up care: A qualitative research.

The aim of this study was to explore adolescent survivors' views and expectations about long-term follow-up care. Semi-structured, in-depth interviews were conducted with 16 adolescent survivors of childhood acute lymphoblastic leukaemia. Survivors who had completed treatment at least 2 years ago were involved in the study. Interviews were audio-recorded and transcribed verbatim. An inductive thematic approach was used to analyse the data. Four main themes and sub-themes were identified from the analysis as follows: information needs with three sub-themes 'long-term follow-up, healthy life and social life', support needs with three sub-themes 'psychosocial (peer relations etc.), school related and social-emotional (fear of relapse, body image, self-esteem, etc.)', perceived benefits with two sub-themes 'social-emotional and related to long-term follow-up' and perceived barriers 'medical-hospital related and social life'. Adolescent survivors mainly need support in terms of psychosocial aspects: self-esteem-body image, school, peer relations and social activities during follow-up. Identified barriers related to follow-up were school absence and not able to participate social activities. Adolescents specify health promotion approaches as benefits aspects of follow-up. The findings of this study will guide nurses in the long-term follow-up care of adolescent survivors of acute lymphoblastic leukaemia and provide an opportunity to plan individualised follow-up care.

A non-inferiority randomized phase III trial of standard immunotherapy versusreduced dose intensity in responding patients with metastatic cancer: MOIO study.

TPS2674 Background: Immunotherapy (IO) is increasingly used for treating various metastatic cancers. With respect to the pharmacologically-active levels of IO drugs and their pharmacokinetics features, standard scheduling lead to plasma exposures largely exceeding the thresholds associated with target engagement. Indeed, phase I studies have shown that saturation of the target can persist far beyond the serum IO drugs half-life. In silico modeling has suggested that alternate scheduling (i.e. 3-monthly dosing) could be performed without compromising efficacy. Indeed, prolonged IO half-lives, time-varying clearance plus plasma concentrations far above the threshold associated with maximal target-engagement, suggest that the rhythm of IO administration could be slowed down. A phase II showed that extending IO dosing intervals did not compromise efficacy, while reducing toxicity in metastatic renal cell cancer. Methods: This non-inferiority, randomized, French national multicenter (36 centers involved) phase III study (NCT05078047) aims to compare the standard scheduling of a variety of IO drugs VS. 3-monthly scheduling in adult patients with metastatic cancer in partial (PR) or complete response (CR) after 6 months of standard IO dosing (except melanoma in CR). The main objective is to demonstrate the non-inferiority in Progression-Free Survival (PFS) of the reduced intensity group compared to the standard regimen. Secondary objectives are cost-effectiveness, quality of life, anxiety and fear of relapse, response rate, overall survival, and toxicity. A 1:1 randomization by minimization will be conducted on the following stratification factors: therapy line (first line vs others), tumor type, IO type (anti-PD-1 vs anti-PD-L1) and response status (PR, CR). A total of 646 pts will be randomized to get the 498 events necessary to prove non-inferiority between groups. The main analysis will conclude that reduced dose intensity is non-inferior to standard scheduling if the hazard ratio for PFS, estimated by a Cox model after adjustment for stratification factors, is significantly lower than the predefined 1.30 non-inferiority margin. In order to minimize the number of patients exposed to suboptimal treatment, an independent data monitoring committee will specifically review the efficacy data and recommend the early termination of the trial if lack of efficacy is evidenced. Ancillary studies of pharmacokinetics and immune-monitoring will be conducted to provide mechanistic insights supporting the clinical outcomes observed in both groups. Conclusion Should the hypothesis of non-inferiority with an IO reduced dose intensity be validated, alternate scheduling could preserve efficacy while being cost-effective and allowing a reduction of the toxicity, with an increase in patient’s quality of life. Clinical trial information: NCT05078047.