Symptom Threshold Research Articles

Posttraumatic stress disorder in disaster-exposed youth: examining diagnostic concordance and model fit using ICD-11 and DSM-5 criteria

BackgroundCompeting definitions of posttraumatic stress disorder (PTSD) have been proposed by ICD-11 and DSM-5; it is unclear which diagnostic model works best for children and adolescents. Although other studies have predicted the impact of these models by approximating the criteria using older measures, this study advances the research by comparing measures designed to assess ICD-11 and DSM-5 criteria in hurricane-exposed youth. This study evaluates ICD-11 and DSM-5 (both the standard and preschool-age) diagnostic models by identifying diagnostic rates, evaluating diagnostic concordance, investigating the predictive value of constructs associated with PTSD (demographics, disaster threat and exposure, functional impairment), and examining model fit.MethodThe sample was exposed to Hurricane Ian (2022), a deadly Category 5 hurricane. Parents reported on disaster exposure and their child’s PTSD symptoms (n = 152; ages 7–17) using the International Trauma Questionnaire for Children and Adolescents Caregiver Version (ITQ-CG) for ICD-11 criteria and UCLA PTSD Reaction Index for DSM-5, Parent/Caregiver Report Version (RI-5) for DSM-5 criteria.ResultsICD-11 PTSD symptom criteria rates were 24% and dropped to 20% when the impairment criterion was added. PTSD symptom criteria rates were 11% (10% with impairment) for DSM-5 and 13% (12% with impairment) for DSM-5 Preschool. ICD-11 rates were higher than DSM-5 and DSM-5 Preschool rates. There was no difference between DSM-5 and DSM-5 Preschool rates of PTSD. There was moderate to substantial concordance between ICD-11 and the DSM-5 models. All diagnostic models were associated with exposure and impairment, but only ICD-11 was associated with threat. ICD-11 was the only one to evidence acceptable model fit.ConclusionsUsing the ITQ-CG and RI-5 to assess PTSD in youth, results showed higher PTSD diagnostic rates for ICD-11 than DSM-5; this contradicts prior findings (based off approximated ICD-11 criteria) and seems largely due to differences in symptom thresholds used by the two measures. The ITQ-CG exhibited excellent model fit and was associated with several constructs important to PTSD.

Detecting and classifying eco-anxiety: development of clinical cut-off scores for the climate change anxiety scale

BackgroundClimate change anxiety, that is worry and fear in relation to the awareness of the impacts of climate change, is widely observed around the world. Some evidence suggests that while climate change anxiety can, at times, be adaptive, a growing body of research has reported that climate change anxiety is also related to a range of negative mental health outcomes and psychological distress. Currently, however, there is limited ability to assess for elevated levels of climate change anxiety and to identify those who may need support. The present study, therefore, aimed to develop clinical cut-off scores on a measure of climate change anxiety.MethodsA largely representative sample of Australian young adults (aged 16–25 years) completed measures of psychological distress (Depression, Anxiety and Stress Scale-21) and the Climate Change Anxiety Scale. Markers of clinically meaningful psychological distress – elevated depression, anxiety, and stress symptoms—were used to classify cases. Receiver Operating Characteristics analyses were performed to assess the predictive ability of the indicators of psychological distress (mild, moderate, severe, and extremely severe thresholds of anxiety, depression, and stress symptoms) for detecting climate change anxiety and to ascertain optimal cut-off scores.ResultsThe Area Under the Curve was acceptable to moderate for detecting climate change anxiety across all analyses. Across symptom severity thresholds and markers of psychological distress, based on consideration of balancing sensitivity and specificity, results consistently suggested that a cut-score of 21 was indicative of mild-moderate climate change anxiety, with a cut-off score of 23 indicating severe-extremely severe climate change anxiety.ConclusionsThe proposed cut-offs can feasibly be used to identify those with elevated climate change anxiety. Use of these cut-off scores can inform research as well as be used to guide screening, assessment, and inform clinical practice. Results also highlight a high rate of climate change anxiety in young adults.

Delirium Motor Subtypes and Severity of Physical Symptoms in Patients with Advanced Cancer in Inpatient Hospice/Palliative Care Units: A Multicenter Prospective Cohort Study.

Background: Altered cognitive function due to delirium changes the threshold or tolerance of symptoms. The impacts of delirium motor subtypes on symptoms remain unknown. Objectives: Determining whether delirium motor subtypes are associated with the severity of physical symptoms in a palliative care setting. Design: A secondary analysis of a multicenter prospective observational study. Setting/Subjects: We included consecutive patients with advanced cancer admitted to 23 inpatient hospices in Japan in 2017. Measurements: Occurrence of delirium, motor subtype, and severity of pain and dyspnea (Integrated Palliative Care Outcome Scale) were assessed at admission (T1) and on the day of Palliative Performance Scale declined to 20 (T2). Results: T1 and T2 data were obtained from 1896 and 1396 patients, respectively. Using patients without delirium as a reference, the odds ratio (OR) for moderate-to-overwhelming pain among those with hyperactive or mixed delirium was significantly higher at T1 and T2 (OR, 95% confidence interval [CI]: 1.49, 1.15-1.92, and 1.71, 1.26-2.32, respectively). A similar trend was observed for dyspnea at T1 and T2 (OR, 95% CI: 1.54, 1.16-2.06, and 1.88, 1.39-2.55, respectively). However, patients with hypoactive delirium did not have higher odds of developing severe symptoms. Patients without delirium at T1, who developed hyperactive or mixed delirium, had a higher severity of both pain and dyspnea than those who were delirium-free (OR, 95% CI; 1.60, 1.08-2.37, and 1.86, 1.27-2.72, respectively) at T2. Conclusion: Hyperactive delirium is associated with the intensity of pain and dyspnea in patients receiving palliative care.

Predictors of persistent symptoms in eosinophilic esophagitis after remission: fibrostenosis, eosinophilia, anxiety, and depression.

Eosinophilic Esophagitis (EoE) is a chronic inflammatory esophageal disorder, often associated with dysphagia, chest discomfort, and heartburn. There is limited information on persistent esophageal symptoms despite histologic remission (HR). We aimed to assess the prevalence and predictors of persistent esophageal symptoms in adult patients with EoE in HR. We performed a retrospective cohort study of adult EoE patients in HR (<15 eosinophils per high power field [eos/hpf]). Exclusion criteria included: no available data on symptoms, chronic opiate use, disorders of esophagogastric junction outflow on Chicago Classification version 4 diagnosis, esophageal candidiasis, erosive esophagitis, or other known cause of esophageal dysphagia besides EoE. Based on prior literature, definitions include: complete HR (<5 eos/hpf), partial HR (5-14 eos/hpf), and endoscopic fibrostenosis (rings and/or stricture). Esophageal symptoms were assessed within 2weeks of HR and categorized into the major symptoms of dysphagia, chest pain, and heartburn. Given the retrospective nature of the study, a global symptom response (absence or presence) was used. Demographics, disease history, endoscopy reports, EoE endoscopic reference score, and histology were recorded. Univariate and multivariable logistic regression analyses were performed. Eosinophil thresholds for persistent symptoms were determined using receiver operating characteristics analyses. Of 289 EoE patients in HR, 133 (46%) had esophageal symptoms: dysphagia (N = 119; 41.2%), heartburn (N = 28; 20.8%), and chest pain (N = 10; 7.5%). Significant predictors for persistent dysphagia were anxiety (adjusted odds ratio [aOR] 3.77) and endoscopic fibrostenosis (aOR 3.87). Significant predictors for persistent heartburn with or without chest pain were anxiety or depression (aOR 12.2 and aOR 11.0) and partial HR (aOR 1.17 and aOR 1.18). Threshold eosinophil counts for persistent heartburn and chest pain were 2.5 and 3.5 eos/hpf, respectively (AUC 0.71 and 0.69). We report a high prevalence of persistent esophageal symptoms in EoE patients who are in HR. Risk factors include anxiety, depression, endoscopic fibrostenosis, and partial HR. These findings can help direct patient care, including endoscopic dilation and managing psychiatric comorbidities. Targeting less than 2.5 and 3.5 eos/hpf for heartburn and chest pain may be warranted.

Cancer incidence and mortality among patients with new-onset atrial fibrillation: A population-based matched cohort study

BackgroundUnderstanding the risk of cancer after the diagnosis of another condition can present opportunities for earlier diagnosis. We examined the risk of cancer diagnosis conditional on prior diagnosis of atrial fibrillation (AF). MethodsLinked electronic health records were used to identify patients aged ≥18 with new-onset AF and age-sex-matched controls. Cumulative incidence of and mortality from cancer (overall and cancer-site specific) within three months, three months to five years and beyond five years from diagnosis of AF were examined. Findings were further validated using Mendelian randomisation (MR). ResultsThe cohort included 117,173 patients with new-onset AF and 117,173 matched controls (median age 78). In the first three months, 2.2% of AF patients were diagnosed with cancer vs. 0.47% in controls (relative risk: 4.7 [95%CI 4.2-5.4] in men and 4.4 [95%CI 3.8-5.0] in women). Nearly 80% of cancers related to thoracic or abdominal organs. Differences in cumulative incidence were only evident in women between three months and five years (subdistribution hazard ratio=1.1 [95%CI 1.01-1.12]) and absent in all patients beyond five years. MR analysis did not support the presence of a causal association between AF and major cancer subtypes. ConclusionThere is a large short-term increase in cancer incidence and mortality following new-onset AF. The findings may reflect incidental identification of AF or paraneoplastic manifestation. New-onset AF confers high short-term risk of cancer diagnosis, at levels comparable with symptomatic risk threshold mandating urgent assessment for suspected cancer.

Identifying thresholds for meaningful improvements in NTDT-PRO scores to support conclusions about treatment benefit in clinical studies of patients with non-transfusion-dependent beta-thalassaemia: analysis of pooled data from a phase 2, double-blind, placebo-controlled, randomised trial

ObjectivesTo estimate thresholds for defining meaningful within-patient improvement from baseline to weeks 13–24 and interpreting meaningfulness of between-group difference for the non-transfusion-dependent beta-thalassaemia patient-reported outcome (NTDT-PRO) tiredness/weakness (T/W) and shortness...

Refining Research Diagnostic Criteria for Catatonia Among Delirium, Medical, Affective, and Psychosis Patient Groups.

The authors proposed catatonia diagnostic criteria that require the presence of three neuropsychiatric symptom clusters, rated over 24 hours; this system differs from other symptom clustering proposals and is intended to increase diagnostic rigor over Bush-Francis Catatonia Rating Scale (BFCRS) or DSM-5 criteria. By applying new BFCRS item score thresholds, symptoms were clustered into three categories to comprise the Research Diagnostic Criteria for Catatonia (RDCC): akinesia (criterion A), unusual motor signs (criterion B), and behavioral signs (criterion C). RDCC symptom clusters were analyzed in four prospectively evaluated patient groups (delirium, medical, affective, and psychosis) (N=341). Use of the RDCC, compared with the DSM-5-TR and BFCRS, resulted in far fewer diagnoses of catatonia in the four patient groups: medical, N=1 out of 42 (2%); affective, N=1 out of 45 (2%); psychosis, N=3 out of 53 (6%); and delirium, N=0 out of 201. Permutations of the RDCC with more relaxed criteria were assessed, requiring either symptom thresholds or numbers of symptoms to meet criteria, resulting in catatonia rate gradations between those obtained with the RDCC and those obtained with current systems. The Cochrane Q test found that the DSM-5-TR was not dissimilar to the RDCC, if fulfilling numerical thresholds for criteria A-C, although any level of symptom severity was allowed. Confirmatory factor analysis with three goodness-of-fit indexes validated the RDCC. The RDCC requires akinetic symptoms on the basis of literature demonstrating their high BFCRS prevalence and exploratory factor analysis co-loadings, plus symptoms from unusual motor and behavioral signs. Compared with current lenient diagnostic approaches, having the symptoms required by the RDCC produced lower catatonia rates in the psychosis, affective, and medical groups and revealed no patients with catatonia in the delirium group. Subdividing DSM-5-TR symptoms into several different criteria may improve diagnosis. RDCC symptom clusters are both research data-based and amenable to further research for validation.

Novel scale for evaluating the therapeutic efficacy of per-oral endoscopic myotomy in achalasia.

Symptom scales for achalasia after per-oral endoscopic myotomy (POEM) are lacking. This study aimed to propose a new scale based on the conventional Eckardt score (c-ES) and evaluate persistent symptoms that impair patients' quality of life (QOL) post-POEM. Dysphagia, regurgitation, and chest pain frequencies were assessed using a 6-point scale modified-ES (m-ES) after POEM, with "occasional" symptoms on the c-ES further subdivided into three-period categories on m-ES. Symptom severity was further evaluated using a 5-point scale ranging from 1 to 5 points, with a score ≥ 3 points defined as persistent symptoms impairing QOL. We analyzed the correlation between the m-ES and severity score, diagnostic performance of the m-ES for persistent symptoms, and overlaps between each residual symptom. Overall, 536 patients (median follow-up period, 2.9years) post-POEM were included in this multicenter study. Significant correlations were observed between the m-ES and severity scores for dysphagia (r = 0.67, p < 0.01), regurgitation (r = 0.73, p < 0.01), and chest pain (r = 0.85, p < 0.01). Twenty-six patients (4.9%) had persistent symptoms post-POEM, and 23 of them had m-ES-specific symptom frequency ≥ once a month, which was determined as the optimal frequency threshold for screening persistent symptoms. The total m-ES predicted persistent symptoms more accurately than the total c-ES (area under the curve: 0.95 vs. 0.79, p < 0.01). Furthermore, dysphagia and chest pain were the major residual symptoms post-POEM covering 91.4% of regurgitation. The new post-POEM scale successfully evaluated the QOL-based patient symptom severities. Our study implied the possibility of a simpler scale using residual dysphagia and chest pain.

Association between cup fixation screw and iliopsoas impingement after total hip arthroplasty

BackgroundIliopsoas impingement after total hip arthroplasty can result not only from acetabular cup but also from cup fixation screw. However, research addressing this screw impingement is scarce, leaving the details undetermined. This study aimed to elucidate the incidence and threshold of symptomatic iliopsoas impingement attributable to protrusion of the cup fixation screw into the iliopsoas muscle and to evaluate its impact on postoperative radiographic imaging findings and patient-reported outcome measures. MethodsA total of 152 hips were included in this study. The symptomatic threshold of screw protrusion was determined using a receiver operating characteristic curve, and patients were divided into low-protrusion and high-protrusion groups using this threshold. The area and Hounsfield Unit values of the iliopsoas muscle on CT and the Japanese Orthopaedic Association Hip Disease Evaluation Questionnaire postoperatively were investigated. Findings10 hips (6.5%) were exhibited symptoms of IPI in this series. The threshold for screw protrusion length was identified as 6.4 mm. Patients in the high protrusion group exhibited significantly larger area and lower Hounsfield Unit values of the iliopsoas muscle. In addition, the high protrusion group revealed significantly lower scores (total, pain, movement, mental). Furthermore, subscales scores (pain, movement) in the high protrusion group didn't improve from 3 months to 12 months postoperatively with significance. InterpretationThis study underscores the imperative for surgeons to consider the length of the cup fixation screw. This careful consideration is crucial for mitigating the incidence of postoperative iliopsoas impingement and enhancing total hip arthroplasty outcomes.

825 Still FIT for Purpose? Learning From False Negative Faecal Immunochemical Tests in Symptomatic Colorectal Cancer Patients

Abstract Aim Faecal immunochemical testing (FIT) is a non-invasive screening tool used to aid the detection of colorectal cancers (CRC) by measuring microscopic levels of blood in the stool. The symptomatic threshold is recommended as ≥10μg Hb/g. The use of FIT alongside red flag symptoms provides a higher positive predictive value for diagnosing CRC. We aim to identify delays in the diagnosis and treatment in false negative FIT patients and to improve the pathways of urgent suspected CRCs. Method A prospective cohort of CRC 439 patients under Hywel Dda University Health Board multidisciplinary team (MDT) was reviewed. Exclusion criteria consisted of patients with anorectal mass, anal ulceration or emergency presentation. Data were collected and analysed to appraise the referral process, FIT timing and results, clinical, pathological and oncological outcomes. Results A total of 366 patients (175F:191M) were analysed. There was a false negative rate of 3.8% (n=14). The mean time taken from FIT to diagnosis for these patients was 53.9 days. The main subsequent diagnostic modality was CT (n=10). The average times taken from referral to the first diagnostic modalities (CT colonography and Endoscopy) were 51.6 days and 106 days respectively. Conclusions This study examined the clinical and oncological consequences of false-negative FIT results in CRC patients. It highlighted the need for expert clinical judgment through MDT input and complementary diagnostic modalities to minimize diagnostic delays and improve patient outcomes. This analysis has helped improve referral pathways in a single centre MDT for urgent suspected CRCs.

Symptoms reported by patients using an ePRO compared with those reported to nurses via telephone triage.

1542 Background: It is unclear how symptoms reported by an electronic patient-reported outcomes (ePRO) tool compare to symptoms reported to triage nurses by patient-initiated telephone calls. This work describes symptoms reported using each of these methods, and the percent of patients requiring an acute office visit triggered by these symptom reports. Methods: Among patients diagnosed with breast, lung, or colon cancer at three community oncology practices from 2020 to 2023, we examined ePRO symptom reports and compared these with symptoms reported via telephone triage to nurses by patients not using the ePRO tool. Results: 3,509 patients reported symptoms by ePROs, and 9,071 patients only reported by phone. Among patients reporting by ePRO, 2,162 submitted both ePROs and used telephone triage services. The most common symptoms that patients reported by ePRO reports (47,284 reports) were weakness / fatigue (72.9% of patients), pain (62.0%), nausea (39.2%), and headache (33.1%). The most common symptoms that patients reported by phone reports (19,344 reports) were pain (32.9%), weakness / fatigue (13.4%), swelling (11.1%), cough (10.3%), and diarrhea (9.4%). The median number of reports in the ePRO group was 6.0 (mean 13.5, IQR: 2.0, 15.0) per patient and the median number of reports in the phone triage group was 1.0 (mean 2.1, IQR: 1.0, 2.0) per patient. The most common high-urgency symptoms in the ePRO group (defined by practice defined symptom threshold) were weakness / fatigue (67.2% of patients), pain (55.7%), headache (40.2%), nausea (32.0%), and difficulty breathing (29.2%), while the most common high-urgency symptoms (as determined by the triage nurse) in the phone triage group were pain (32.4%), weakness / fatigue (11.8%), swelling (11.4%), fever/chills (10.1%), and cough (9.7%). More patients reported high-urgency symptoms by ePRO (n = 1,873, 53.4%) compared to those reported by phone triage (n = 2,448, 27.0%). Of patients in the ePRO group with a severe symptom who visited a site with acute care visits data, 330 patients (45.4%) had an acute care visit within 72 hours of a symptom report compared to 745 patients (47.5%) in the telephone triage group. Conclusions: Patients using ePROs reported more symptoms than patients reporting by phone, possibly because electronic reporting allows patients to easily communicate symptoms to care providers and receive prompt attention. Pain and weakness/fatigue were the most common urgent symptoms in both groups. The need for an acute care visit was the same in both groups. Further refinement of the ePRO tool including standardization of symptom thresholds, more uniform implementation in practices, and patient education with respect to optimal use of the ePRO may enable practices to replace telephone triage with ePROs.

Defining the Patient Acceptable Symptom State (PASS) for PROMIS After Total Ankle Replacement.

Although patient-reported outcomes (PROs), such as the Patient-Reported Outcomes Measurement Information System (PROMIS), are a key element of evaluating success after total ankle replacement (TAR), many do not explicitly state a key factor of postoperative success: is the patient satisfied with their outcome after TAR? The patient acceptable symptom state (PASS) represents the symptom threshold beyond which patients consider themselves well. This study aimed to establish the PROMIS thresholds for the PASS in a primary cohort of TAR patients. This single-institution study included 127 primary TAR patients with preoperative and 2-year postoperative PROMIS scores. At 2 years postoperatively, patients answered 2 PASS anchor questions (Satisfaction, Delighted-Terrible scale) with Likert-scale responses. PASS thresholds with 95% confidence intervals (CIs) were calculated from PROMIS scores using an anchor-based method. Using a bootstrapping technique with 1,000 iterations, the Youden index was calculated to determine the best specificity and sensitivity coordinates to maximize their combination. Finally, preoperative variables associated with the likelihood of achieving the PASS were assessed. There was a strong association between PASS thresholds and PROMIS domains, especially Pain Interference (PASS threshold of <56.0, area under the receiver operating characteristic curve [AUC] = 0.940), Pain Intensity (<48.4, AUC = 0.936), and Physical Function (>44.7, AUC = 0.883). The likelihood of achieving the PASS was not affected by age, race, gender, American Society of Anesthesiologists (ASA) class, body mass index, or severity of ankle deformity. Patients with worse preoperative Physical Function and Global Mental Health scores were less likely to meet the PASS threshold for Physical Function postoperatively (p = 0.028 and 0.041). The ability to reach the PASS after TAR was most strongly associated with postoperative PROMIS pain scores. However, PASS thresholds were generally poorer than population means. This demonstrates that patients do not need to reach normal pain or physical function levels to have an acceptable symptom state after TAR. Prognostic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Research on the optimization of belief rule bases using the Naive Bayes theory

The belief rule base is crucial in expert systems for intelligent diagnosis of equipment. However, in the belief rule base for fault diagnosis, multiple antecedent attributes are often initially determined by domain experts. Multiple fault symptoms related to multiple antecedent attributes are different when an actual fault occurs. This leads to multiple antecedent attributes matching with multiple fault symptoms non-simultaneously, thereby resulting in a fault diagnosis lacking timeliness and accuracy. To address this issue, this paper proposes a method for belief rule-based optimization based on Naive Bayes theory. First, a fault sample is taken in a long enough window and divided into several interval samples, making the analysis samples approximate the overall samples. Second, using Gaussian mixture clustering and Naive Bayes optimization, iteration is performed over the threshold and limit values of fault symptoms in the belief rule base based on the requirements of the timeliness and accuracy of fault diagnosis results. Finally, the belief rule base is optimized. Using fault samples from high-pressure heaters and condensers, the validation results show that there is a there is a significant improvement in the timeliness and accuracy of fault diagnosis with the optimal belief rule base.

A potential role for GPR107 in the development of Hypoglycemia Unawareness

Diabetes remains one of the largest health burdens in modern society and while an estimated 37.3 million people suffer from either type 1 or type 2 diabetes worldwide, a further 96 million people are currently estimated to be prediabetic. So far, most efforts for diabetic therapies have been focused on insulin-replacement therapies and secretagogues; however, a common risk associated with these therapies is hypoglycemia. Hypoglycemia is defined as low plasma glucose levels (&lt; 70 mg/dl) and can lead to loss of consciousness and death. Recently, it has been established that repeated exposure to bouts of hypoglycemia in diabetic individuals likely impairs sympathoadrenal counter regulation, and shifts the glycemic threshold for symptoms to lower plasma glucose concentrations, close to levels which result in cognitive failure. This pathology has been titled hypoglycemia unawareness (HU) and constitutes a major risk factor for developing severe hypoglycemia. The development of severe hypoglycemia in diabetics accounts for a six-fold increase in mortality, compared to diabetic individuals who do not experience severe hypoglycemia. Thus, it is important to understand how to prevent and reverse its development. We have developed a novel rat model of HU in which rats are exposed to insulin-induced recurrent hypoglycemia for five consecutive days. In this model of HU, we found that GPR107 expression is dramatically increased in the hypothalamus of rats exhibiting loss of hypoglycemia-induced food intake. Our group previously identified GPR107 as a receptor for neuronostatin (NST), a 13 amino acid peptide derived from the somatostatin prepro-hormone, which can exert anorexigenic actions in the hypothalamus. Using a GPR107-flox rat model we are currently evaluating the effect of hypothalamic knock-down of GPR107 on the development of HU and basal feeding behavior. We anticipate that if knock-down of GPR107 reverses HU, the development of NST antagonists could potentially be useful therapeutically for diabetic patients who experience recurrent hypoglycemia. Our GPR107-flox rat model will enable us to identify upstream and downstream interacting partners of GPR107/NST. This could reveal hypothalamic pathways involved in the development of HU that also could serve as potential therapeutic targets for this devastation consequence of iatrogenic hypoglycemia. Internal Funds St. Louis University. This is the full abstract presented at the American Physiology Summit 2024 meeting and is only available in HTML format. There are no additional versions or additional content available for this abstract. Physiology was not involved in the peer review process.

Electronic Patient-Reported Outcome-Based Symptom Management Versus Usual Care After Lung Cancer Surgery: Long-Term Results of a Multicenter, Randomized, Controlled Trial.

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.We previously reported superior symptom control of electronic patient-reported outcome (ePRO)-based symptom management after lung cancer surgery for up to 1 month postdischarge. Here, we present the long-term results (1-12 months) of this multicenter, randomized trial, where patients were assigned 1:1 to receive postoperative ePRO-based symptom management or usual care daily postsurgery, twice weekly postdischarge until 1 month, and at 3, 6, 9, and 12 months postdischarge. Long-term patient-reported outcomes were assessed with MD Anderson Symptom Inventory-Lung Cancer module. Per-protocol analyses were performed with 55 patients in the ePRO group and 57 in the usual care group. At 12 months postdischarge, the ePRO group reported significantly fewer symptom threshold events (any of the five target symptom scored ≥4; median [IQR], 0 [0-0] v 0 [0-1]; P = .040) than the usual care group. From 1 to 12 months postdischarge, the ePRO group consistently reported significantly lower composite scores for physical interference (estimate, -0.86 [95% CI, -1.32 to -0.39]) and affective interference (estimate, -0.70 [95% CI, -1.14 to -0.26]). Early intensive ePRO-based symptom management after lung cancer surgery reduced symptom burden and improved functional status for up to 1 year postdischarge, supporting its integration into standard care.

How Many Criteria Should be Required to Define the DSM-5 Mixed Features Specifier in Depressed Patients?

IntroductionDuring the past 2 decades there has been intense interest in the clinical significance of the concurrence of manic symptoms in depressed patients. DSM-5 introduced a mixed features specifier for both bipolar depression and major depressive disorder. Studies of the DSM-5 mixed features specifier have generally found a low prevalence of mixed depression. One approach towards increasing the sensitivity of the DSM-5 mixed features criteria is to lower the classification threshold.ObjectivesIn the present study we examine the impact of lowering the DSM-5 diagnostic threshold from 3 to 2 criteria on the prevalence and validity of the DSM-5 mixed features specifier for depression.MethodsFour hundred fifty-nine psychiatric patients in a depressive episode were interviewed by a trained diagnostic rater who administered semi-structured interviews including the DSM-5 Mixed Features Specifier Interview. The patients were rated on clinician rating scales of depression, anxiety and irritability, and measures of psychosocial functioning, suicidality, and family history of bipolar disorder.ResultsIf the DSM-5 diagnostic threshold is lowered from 3 to 2 symptoms, then the prevalence of mixed features based on the DSM-5 majority of episode time frame tripled from 3.9% to 13.1% (n=60). Based on a past week time frame prevalence more than doubled from 9.4% to 22.9% (n=105) going from the 2 and 3 symptom threshold, respectively. There was no difference between the patients with 2 mixed features and patients with 0 or 1 mixed features on family history of bipolar disorder, psychosocial impairment, presence of comorbid disorders, age of onset, history of suicide attempts or psychiatric hospitalization.ConclusionsThe results of the present study do not support lowering the DSM-5-TR diagnostic threshold for the mixed features specifier in depressed patients from 3 to 2.Disclosure of InterestNone Declared

Defining the Patient Acceptable Symptom State (PASS) for PROMIS After Hallux Valgus Correction Surgery

Introduction/Purpose: Surgical interventions to correct hallux valgus have been shown to improve patient reported outcomes (PROs); however, many of these instruments do not measure a patient’s subjective outcome experience. The patient acceptable symptom state (PASS) is defined as the symptom threshold that a patient must reach to be satisfied with the outcome of their surgery. PASS thresholds have been defined for hallux valgus correction using American Orthopaedic Foot &amp; Ankle Society (AOFAS) scores; however, no studies have used a validated PRO metric. This is the first study that aims to establish PASS thresholds for Patient-Reported Outcome Measurement Information System (PROMIS) scores in patients following operative intervention for hallux valgus. Methods: A retrospective review of prospectively collected data within an institutional registry was performed. We identified 291 patients treated for hallux valgus with or without second hammertoe correction between February 2019 and March 2021 with at least 2-year post-operative PROMIS scores. Chart review was performed to obtain demographic information and to confirm the surgical procedures completed. Two-years post-operatively, patients answered two PASS anchor questions (Satisfaction, Delighted-Terrible scale) with Likert-scale responses, which was collected along with pre-operative and 2-year post-operative PROMIS scores via the registry. After patient’s answers to the Satisfaction and Delighted-Terrible scales were recategorized into binary responses; PASS thresholds were determined using the maximum Youden Index and a 95% confidence interval was quantified using 2000 bootstrapped iterations. Differences in patient and surgical characteristics between patients who met or did not meet the PASS threshold were compared using independent samples t-test and Pearson chi square. Results: There was excellent association between PASS thresholds and the PROMIS domains of Physical Function (50.3, AUC=0.86) and Pain Interference (51.5, AUC=0.86). Overall, 204/291 and 205/291 patients met the threshold for Physical Function (PF) and Pain Interference (PI), respectively. For both PROMIS domains, a lower BMI was associated with a higher likelihood of meeting the PASS threshold (p=0.002 for PF, p=0.032 for PI). For the PF domain, Lapidus patients were more likely to meet the PASS threshold (p=0.05), and patients with first MTP fusion were less likely to meet the PASS threshold (p=0.004). Meeting the PASS threshold wasn’t impacted by the concomitant correction of a second hammertoe. Lastly, patients with a higher pre-operative PF score had a greater chance of meeting the PASS threshold (p &lt; 0.001). Conclusion: This is the first study to define a PASS threshold for hallux valgus correction using PROMIS scores, a validated outcomes measure. Pre-operative PROMIS scores, patient BMI, and the type of procedure performed impacted a patient’s likelihood of meeting the PASS threshold. These results may be helpful in counseling and educating patients on their chances of obtaining a satisfactory result following hallux valgus correction.

Levels of IgE sensitization drive symptom thresholds in allergic rhinitis

BackgroundAllergic rhinitis (AR) is a common respiratory disease encompassing a variety of phenotypes. Patients can be sensitized to 1 or more allergens. There are indications that polysensitization is associated with more severe disease. However, the extent to which the level of sensitization is associated with clinical disease variability, underlying the distinct nature of AR from AR+ conjunctivitis or AR+ asthma, is not known. ObjectiveTo evaluate phenotypical differences between monosensitized and polysensitized patients with AR and to quantify their symptomatic variability. MethodsA total of 565 patients with a confirmed diagnosis of AR were included in this cross-sectional study. Of those, 155 were monosensitized and 410 were polysensitized. Interactions between sensitization levels and the reporting of different symptoms of AR and co-morbidities, disease duration, and impact were assessed. Furthermore, patients were stratified into monosensitized, oligosensitized, and polysensitized to assess whether the effect of sensitization on the phenotype was ranked. ResultsPolysensitized patients reported itchy eyes significantly more often (P = .001) and had a higher number of ocular (P = .005), itch-related (P = .036), and total symptoms (P = .007) than monosensitized patients. In addition, polysensitized adults and children more often reported wheeze (P = .015) and throat-clearing (P = .04), respectively. Polysensitization was associated with more burdensome AR based on a visual analog scale (P = .005). Increased sensitization level was reflected in more itchy eyes, a higher number of ocular, itch-related, and total number of symptoms, and disease burden. ConclusionWith an increasing number of sensitizations, patients with AR experience an increased diversity of symptoms. Multimorbidity-related symptoms increase with sensitization rank, suggesting organ-specific thresholds.

Defining the Patient Acceptable Symptom State Using PROMIS Following Reconstruction of the Progressive Collapsing Foot Deformity

Introduction/Purpose: Although reconstruction of the flexible progressive collapsing foot deformity (PCFD) has been shown to improve patient-reported outcomes (PROs), there is limited data describing postoperative success as defined by patient satisfaction following surgery. Distinct from the minimal clinically important difference (MCID), the patient acceptable symptom state (PASS) is a novel PRO measurement that represents the symptom threshold beyond which patients are satisfied with their postoperative outcome. The primary aim of this study was to use Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) and Pain Interference (PI) scores in combination with anchor questions to define PASS thresholds following reconstruction of the flexible PCFD. A secondary aim was to analyze how patient-specific variables and certain PCFD reconstruction procedures may impact the probability of reaching PASS thresholds. Methods: Using data collected from a foot and ankle orthopedic registry at a large academic institution, 109 patients who underwent reconstruction of a flexible PCFD between February 2019 and March 2021, had preoperative and 2-year postoperative PROMIS PF and PI scores, and 2-year postoperative responses to two PASS anchor questions (the delighted-terrible scale and the satisfied scale) were included in the study. Patients who underwent either a double or triple arthrodesis were excluded. Patient responses to the anchor questions were dichotomized and receiver operating characteristic (ROC) curve analyses were performed. Using the Youden Index to balance sensitivity and specificity and maximize the area under the curve (AUC), PASS thresholds with 95% confidence intervals were quantified using 2000 bootstrapped iterations. Lastly, multivariable logistic regressions were performed to analyze the influence of patient demographics, preoperative PROMIS scores, and certain PCFD reconstruction procedures on the probability of reaching the PASS thresholds. Results: The PASS threshold for PROMIS PF was found to be 42.6 using both the delighted-terrible and the satisfied scale and 73.4% of patients (80/109) reached the threshold (both AUCs: 0.91) (Table 1). The PASS thresholds for PROMIS PI defined using the delighted-terrible scale and the satisfied scale were 54.5 (AUC: 0.90) and 57.5 (AUC: 0.91), respectively, with 72.5% of patients (79/109) and 81.7% of patients (89/109) meeting the respective thresholds. Neither patient demographics nor specific PCFD reconstruction procedures affected the probability of meeting the PASS thresholds. However, a lower preoperative PROMIS PF score or a higher preoperative PROMIS PI score significantly decreased the probability of achieving the PASS thresholds. Conclusion: Following reconstruction of the flexible PCFD, PASS thresholds for the PROMIS PF and PI domains were found to be lower and higher, respectively, than population norms. This suggests that patients may be satisfied with the outcome of their surgery despite not returning to the population mean. The probability of achieving the PASS thresholds was influenced by both preoperative PROMIS PF and PI scores but not by patient demographics or certain PCFD reconstruction procedures. In addition to guiding future outcomes research, these results may help foot and ankle surgeons optimize treatment for the flexible PCFD and better manage patient expectations.

Application of the patient-reported outcome-based postoperative symptom management model in lung cancer: a multicenter randomized controlled trial protocol

IntroductionLung cancer is the most common cancer in China, with the highest mortality rate. Surgery is the primary treatment for early lung cancer. However, patients with lung cancer have a heavy burden of symptoms within 3 months after surgery, which seriously affects their quality of life (QOL). The symptom management model based on the patient-reported outcome (PRO) is considered the best caregiving model. The clinical evidence about the symptom management of lung cancer within 3 months after the operation is very limited. Herein, we propose a randomized controlled trial to evaluate the PRO score-based monitoring and alert system for follow-up on psychological and physiological symptoms of lung cancer patients within 3 months after surgery and further investigate the effect of intervention measures based on this PRO score-based system.Methods and analysisThis multicenter, open-label, randomized, parallel superiority trial will be conducted at four hospitals in China. A total of 440 lung cancer patients will be recruited in this study, who will be randomly assigned to the intervention group or the control group in a ratio of 1:1. Any of the target symptoms reaches the preset threshold (score ≥ 4), the patients will accept the symptom management advices based on the PRO. The patients in the control group will follow the current standard procedure of symptom management. The symptom management system is an electronic management system based on WeChat mini programs. All patients will be evaluated for symptoms through the lung cancer module of the MDASI lung cancer-specific scale on the day before surgery, days 1, 3, 5, and 7 after surgery, and once a week during the 12-week post-discharge period. Simultaneously, the EORTC QLQ-C30 scale will be used to evaluate patients’ quality of life at baseline and the fourth and twelfth week after the surgery. The mean number of symptom threshold events of the intervention and the control groups were compared by t-test, and the changes of PRO were compared by a mixed effect model. The primary endpoint has been set as the 12-week post-discharge period.DiscussionThis study will test the feasibility of the symptom management system based on the mobile social media applet in postoperative caregiving and the efficacy of psychiatrist-assisted treatment and provide evidence in managing the symptoms of patients in the medium and long term.Trials registrationTrials registration number: ChiCTR 2200058876, Registered 18 April 2022