BACKGROUND: Survivorship care plans (SCPs) are provided at the completion of cancer treatment to aid in the transition from active treatment to long-term survivorship. They describe the details of a patient\'s diagnosis and treatment and offer recommendations for follow-up appointments, referrals, and healthy behaviors. The plans are currently paper-based and become outdated as soon as a patient\'s health status changes. There is a need to digitize these plans to improve their accessibility, modifiability, and longevity. With current technology, SCPs can be linked to mobile devices and activity trackers so that patients can track health behaviors and compare them to their clinical goals, taking charge of their own health.
OBJECTIVE: A mobile app, POSTHOC (POST-Treatment Health Outcomes of Cancer Survivors), that digitizes the SCP was developed, with goals of integrating it with wearable technologies and electronic medical records. Herein, we are conducting a randomized controlled trial that evaluates the POSTHOC app versus the traditional SCP on total symptom burden in the early posttreatment period.
METHODS: We will recruit 54 patients who have recently completed curative therapy for cancer (any type) in person and remotely. They will be randomized 2:1, POSTHOC:usual care (unblinded). Those randomized to the POSTHOC group will receive their SCP via the app and will choose to focus on nutrition or exercise for the duration of the study based on their individual plan and personal preferences. Those randomized to the control group will get a paper-based plan. At baseline, 6 weeks, and 12 weeks, we will evaluate patient-reported outcomes, including total symptom burden (web-based questionnaire), diet (24-hour Automated Self-Administered [ASA24]), and physical activity (Fitbit Charge 6 [Google LLC]). We will also collect quantitative and qualitative feedback on the usability of the app from those in the POSTHOC arm to improve the app for future implementation studies, with a specific focus on patient-provider communication. For feasibility, we will calculate the percentage of patients who used the POSTHOC app at least 3 times per week. We will use linear mixed models to evaluate the effects of the POSTHOC app versus those of usual care on other outcomes at weeks 6 and 12.
RESULTS: This trial is open to accrual in the University of Maryland Medical System as of March 2024, and as of July 3, 2024, a total of 20 participants have consented.
CONCLUSIONS: This study is among the first to digitize the SCP in a mobile app and test the effects of a mobile health-delivered behavioral health intervention on symptom burden in cancer survivors. Our results will provide evidence about the effects of health self-management on symptoms. This knowledge will be integral to larger randomized controlled studies, integration with the electronic medical record, and nationwide implementation.
BACKGROUND: ClinicalTrials.gov NCT05499663; https://clinicaltrials.gov/ct2/show/NCT05499663.
UNASSIGNED: DERR1-10.2196/59222.

Dysbiosis is a clinical condition marked by altered gut microbiota resulting from external and internal host factors. It is strongly associated with gastrointestinal and extraintestinal alterations, so its symptomatology is broad and nonspecific. To date, gaps remain that limit professionals from making a timely diagnosis and prescribing the appropriate treatment. We aim to synthesize existing literature regarding clinical parameters for the early detection of patients with intestinal dysbiosis and the clinical events in which the use of probiotics as adjuvant therapy is most frequently reported. A scoping review of the literature was conducted in PubMed, Embase, Cochrane, and BVS (Biblioteca Virtual en Salud in Spanish) databases for articles published in the last 5 years. Primary studies and literature reviews related to clinical presentation, dysbiosis screening, and probiotics as adjuvant therapy for adult and pediatric patients were included. Twenty-three articles were retrieved in which the most frequently reported symptoms were abdominal distension, abdominal pain, and diarrhea. Chronic and metabolic diseases where the conditions most strongly associated with dysbiosis. Depending on symptomatology and etiology, dysbiosis is often treated with probiotics. Dysbiosis, often linked to diarrhea, should be considered with other symptoms like abdominal distension and pain, along with predisposing conditions and patient risk factors. Probiotics are commonly used as co-adjuvant treatments for antibiotic-associated diarrhea, irritable bowel syndrome, and childhood allergic diseases. The most commonly used probiotics were Weizmannia coagulans (formerly B. coagulans), Alkalihalobacillus clausii (formerly Bacillus clausii), Lacticaseibacillus rhamnosus, Limosilactobacillus reuteri, and Saccharomyces boulardii.

UNASSIGNED: Individuals affected by the post-covid condition (PCC) show an increased fatigue and the so-called post-exertion malaise (PEM) that led health professionals to advise against exercise although accumulating evidence indicates the contrary. The goal of this study is to determine the impact of a closely monitored 8-week mixed exercise program on physical capacity, symptoms, fatigue, systemic oxidative stress and plasma proteomic profiles of PCC cases.
UNASSIGNED: Twenty-five women and men with PCC were assigned sequentially to exercise (n = 15) and non-exercise (n = 10) groups. Individuals with no PCC served as a control group. The exercise program included cardiovascular and resistance exercises. Physical capacity, physical activity level and the presence of common PCC symptoms were measured before and after the intervention. Fatigue was measured the day following each exercise session. Plasma and PBMC samples were collected at the beginning and end of the training program. Glutathione and deoxyguanosine levels in PBMC and plasma proteomic profiles were evaluated.
UNASSIGNED: Bicep Curl (+15% vs 4%; p = 0.040) and Sit-to-Stand test (STS-30 (+31% vs +11%; p = 0.043)) showed improvement in the exercise group when compared to the non-exercise group. An interaction effect was also observed for the level of physical activity (p =0.007) with a positive effect of the program on their daily functioning and without any adverse effects on general or post-effort fatigue. After exercise, glutathione levels in PBMCs increased in women but remained unchanged in men. Discernable changes were observed in the plasma proteomics profile with certain proteins involved in inflammatory response decreasing in the exercise group.
UNASSIGNED: Supervised exercise adapted to the level of fatigue and ability is safe and effective in PCC patients in improving their general physical capacity and wellbeing. Systemic molecular markers that accompany physical improvement can be monitored by analyzing plasma proteomics and markers of oxidative stress. Large-scale studies will help identify promising molecular markers to objectively monitor patient improvement.

BACKGROUND: Web-based self-help (WASH) has been found to be effective in the treatment of child externalizing behavior disorders. However, research on the associations of caregivers\' use of WASH and symptom changes of child externalizing behaviors is lacking.
OBJECTIVE: This study examined the longitudinal and reciprocal associations between the use of WASH by caregivers of children with externalizing behavior disorders and their children\'s externalizing behavior symptoms.
METHODS: Longitudinal data of 276 families from 2 intervention conditions of a randomized controlled trial (either unguided or supported by a therapist over the phone) were analyzed. Caregiver- and clinician-rated child externalizing behavior symptoms were assessed before (T1), in the middle (T2), and after the 6-month WASH intervention (T3). Additionally, 2 indicators of the caregivers\' use of the WASH intervention were considered: number of log-ins (frequency) and the percentage of completed material (intensity). Associations of caregivers\' use during early (T1-T2) and late (T2-T3) treatment with child externalizing behavior symptoms were analyzed using path analyses (structural equation modeling).
RESULTS: Frequency and intensity of use were higher during the first 3 months than during the next 3 months of the intervention period. The number of log-ins at early treatment was significantly but weakly associated with caregiver-reported child externalizing behavior symptoms in the long term (T3). Moreover, caregiver-reported child externalizing severity at T2 predicted the number of log-ins in the late treatment. The results were not replicated when considering the percentage of completed material as a measure of use or when considering clinician ratings of child externalizing behavior symptoms.
CONCLUSIONS: The findings provide the first, albeit weak, evidence for longitudinal associations between caregivers\' use of WASH and improvements in caregiver-rated child externalizing behavior symptoms. However, as the associations were rather weak and could not be replicated across different rater perspectives and operationalizations of use, further research is needed to better understand these relations and their interplay with other putative influence factors (eg, quality of the implementation of the interventions, changes in parenting behaviors).
BACKGROUND: German Clinical Trials Register DRKS00013456; https://www.drks.de/DRKS00013456.
UNASSIGNED: RR2-10.1186/s12888-020-2481-0.

UNASSIGNED: Eosinophilic esophagitis (EoE) is a chronic, inflammatory disease of the esophagus leading to symptoms of esophageal dysfunction; dysphagia is the most common symptom experienced by adults and adolescents.
UNASSIGNED: We sought to perform a psychometric evaluation of the Dysphagia Symptom Questionnaire (DSQ), a patient-reported outcome measure for patients with EoE.
UNASSIGNED: Using baseline and week 24 data from the randomized, interventional, multinational phase 3 R668-EE-1774 trial (NCT03633617), the measurement properties of the DSQ-including reliability, construct and known-groups validity, responsiveness, and interpretation of change-were evaluated.
UNASSIGNED: The analysis population comprised 239 patients with EoE (age [mean ± SD], 28.1 ± 13.14 years; 63.6% male; 90.4% White). Intraclass correlation coefficients of 0.92 and 0.97 exceeded the acceptable reliability threshold (≥0.70). Construct validity correlations with EoE symptom and impact measures were moderate at baseline (|r| = 0.44-0.55) and week 24 (|r| = 0.55-0.69), and the DSQ biweekly total score discriminated among groups defined by disease severity. Analyses exploring interpretation of change from baseline on the DSQ biweekly total score indicated thresholds for within-patient improvement ranging from 9 to 23 points; a within-patient improvement from baseline of 13 points or greater could be considered clinically meaningful.
UNASSIGNED: This analysis confirmed that the DSQ has acceptable distributional properties, test-retest reliability, construct validity, and ability to detect change. Therefore, the DSQ is a valid and reliable measure to assess the patient-reported symptom of dysphagia among adult and adolescent patients with EoE in the context of a clinical trial setting.

Fractional flow reserve fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) is currently recommended in the management of patients with stable coronary artery disease (CAD). Pullback pressure gradient (PPG) index is an emerging concept that provides a fully quantitative measure of the longitudinal distribution of CAD. It can be derived from FFR, as well as other non-hyperemic indices, and is a novel metric of assessing the focality or diffuseness of CAD. PPG adds a second domain to the assessment of CAD, beyond ischemia as measured by FFR, and may enable clinicians to better inform their patients about the status of their CAD but may also predict potential outcomes before revascularization. In this article, we will provide an in-depth review on the concept of PPG index and its correlation to pre and post revascularization ischemia. We will assess the relationship between PPG index and plaque characteristics and how this is translated into any difference in procedural and long-term clinical outcomes.

OBJECTIVE: To better understand the breadth and frequency of symptoms across the phases of the migraine cycle using data captured from qualitative patient interviews conducted through the Migraine Clinical Outcome Assessment System (MiCOAS) project.
BACKGROUND: People living with migraine experience a range of symptoms across the pre-headache, headache, post-headache, and interictal phases of the migraine cycle. Although clinical diagnostic criteria and clinical trial endpoints focus largely on cardinal symptoms or monthly migraine days, migraine symptom profiles are far more complex. As a part of the MiCOAS project, semi-structured qualitative interviews were undertaken to better understand the migraine-related symptomology from the patient\'s viewpoint.
METHODS: This concept elicitation study used iterative purposeful sampling to select 40 people with self-reported medical diagnosis of migraine for interviews that were conducted via audio-only web conferencing. Key topics related to migraine symptoms, including mood/emotion symptoms, were identified using content analysis. Interview transcripts were also coded to reflect the phase of migraine under discussion, so that patient experiences could be compared by phase.
RESULTS: Forty participants (50%, n = 20 episodic migraine; 50%, n = 20 chronic migraine), aged from 21 to 70 years old reported a total of 60 unique symptoms, which were categorized into 30 broader symptom categories. Participants reported between 7 and 22 unique symptom categories across all phases. During pre-headache and headache, participants reported a median of 7.5 (interquartile range [IQR] = 5.5) and 8 (IQR = 4.0) different symptom categories compared to 4 (IQR = 3.0) and 1.5 (IQR = 2.5) for the post-headache and interictal periods, respectively. Head pain during the headache phase was the only universally reported symptom (100%, n = 40). Pooling across all phases, the next most reported symptoms were light sensitivity (93%, n = 37), nausea (88%, n = 35), irritability/impatience (83%, n = 24), sound sensitivity (80%, n = 32), and fatigue/exhaustion (80%, n = 32). One or more interictal symptoms were reported by 73% (n = 29) of participants and included mood/emotion symptoms, such as anxiety (30%, n = 12), depression (18%, n = 7), and anger (15%, n = 6), as well as cardinal symptoms, such as light sensitivity (13%, n = 5) and nausea (13%, n = 5).
CONCLUSIONS: Patients experience a range of symptoms across the phases of the migraine cycle. Results often aligned with clinical expectations, but non-cardinal migraine-related symptoms were reported both inside and outside the headache phase, including between attacks. These discoveries highlight the importance of assessing a range of symptoms and timing when developing patient-reported outcome measures for migraine clinical trials.

The COVID-19 pandemic has led to the emergence of acute and chronic post-COVID syndromes, which present diverse clinical manifestations. The underlying pathophysiology of these conditions is not yet fully understood, but genetic instability has been proposed as a potential contributing factor. This study aimed to explore the differential impact of physical and psychological health factors on genetic instability in individuals with acute and chronic post-COVID syndromes. In this study, three groups of subjects were analyzed: a control group, an acute post-COVID group, and a chronic post-COVID group, with a total of 231 participants. The participants were assessed using a questionnaire for long-COVID-19COVID, and female participants reported more symptoms than male participants in areas related to fatigue, memory, mental health, and well-being during the chronic phase. Genetic instability was assessed using the comet assay, and participants\' physical and psychological profiles were evaluated. The overall results showed no significant differences in DNA damage, as measured by the comet assay, among the three groups, suggesting that genetic instability, as assessed by this method, may not be a primary driver of the distinct clinical presentations observed in post-COVID syndromes. However, when gender was considered, male participants in the acute long COVID group exhibited higher levels of genetic instability compared to females. Multiple linear regression analysis revealed that gender, age, and waist circumference were significant predictors of DNA damage. Among females in the acute group, sexual health, and eye-related symptoms significantly influenced the increase in DNA damage. These findings indicate the need for further investigation on the gender-specific differences in genetic instability and their potential implications for the pathophysiology of post-COVID syndromes. Exploring alternative markers of genetic instability and the interplay between genetic, inflammatory, and cellular processes could provide valuable insights for the management of these debilitating post-viral sequelae.

Many people across the spectrum of chronic kidney disease (CKD) experience a large symptom burden. Measuring symptoms can be a way of responding to the concerns of patients and their priorities of care and may help to improve overall outcomes, including health-related quality of life. The objective of this article is to discuss approaches to measuring symptoms across the spectrum of CKD and to highlight strategies to facilitate the incorporation of routine symptom assessment into kidney care. Specifically, we discuss the use of validated patient-reported outcome measures in CKD as they relate to measuring symptoms, including their benefits and limitations, and describe commonly used patient-reported outcome measures. We discuss potential barriers that should be considered when contemplating the development of a program to routinely measure and address symptoms. Finally, we outline a systematic, stepwise approach to measuring symptoms with implementation strategies to address the common barriers. Although the principles outlined in this article can be applied to research and audit, the principal focus is on symptom measurement aimed at informing clinical practice and directly improving patient outcomes.

BACKGROUND: Hymenoptera venom is one of the most frequent causes of anaphylaxis. Studies from adults indicate the clinical profiles and risk factors of Hymenoptera venom induced anaphylaxis (VIA). Much less is known about pediatric VIA.
OBJECTIVE: To better understand elicitor and age related factors determining pediatric VIA by analyzing data from the anaphylaxis registry.
METHODS: We selected pediatric VIA, pediatric food induced anaphylaxis (FIA) and adult VIA cohorts from the anaphylaxis registry and performed a comparative data analysis regarding elicitors, symptoms and management.
RESULTS: 725 pediatric VIA, 3,149 pediatric FIA and 5,534 adult VIA were identified. In pediatric VIA, boys were more frequently affected, atopy was not increased and the onset of the reaction after exposure was fast (≤ 30 min; 91%) when compared to pediatric FIA. Symptoms in pediatric VIA were age dependent, and although respiratory symptoms occurred besides skin symptoms most frequent in both, pediatric VIA and FIA, cardiovascular symptoms were more frequently reported in pediatric VIA than pediatric FIA. The analysis of pediatric versus adult VIA reveled clear differences of the frequency of involved organ systems (skin: 93/78%, respiratory: 77/64%, and cardiovascular: 61/85%). Among both, the pediatric and adult VIA, the rates of adrenaline application by a professional were low (29/31%) but the hospitalization rates were higher in children than in adults (61%/42%). Venom immunotherapy (VIT) was initiated frequently regardless of age (78% each).
CONCLUSIONS: Pediatric VIA is more frequent in boys, symptoms are age dependent and often hospitalization is required. Adrenaline should be applied according the current guidelines. VIT is an important treatment option in pediatric VIA and should be considered in severely affected children.