1-week Recall Research Articles

Effect of motivational interviewing on preventive strategies for children receiving full-mouth dental rehabilitation under general anesthesia: A randomized controlled trial.

Motivational interviewing (MI) is an approach to increase parental compliance to follow up and recall of their children. It has proven to be successful in motivating parents to adopt and maintain preventive child oral health behaviors. To assess the effectiveness of motivational interviewing on prevention strategies for parents of children who have received full-mouth dental rehabilitation under general anesthesia (GA). This is a parallel-arm randomized controlled trial. Parents in the treatment arm were randomized and received a combination of motivational interviewing, individualized goal setting, visual aids, and verbal education post-GA. Those in the control arm received the same information by verbal and written education. Both groups were evaluated at 2-week follow-up and 3-month recall. Differences in attendance, oral health knowledge, readiness to change, and parental self-efficacy (PSE) were compared between groups and at return visits. Of 74 parents of children randomly allocated in this study, 22 (61%) and 13 (38%) from the intervention group, and 21 (55%) and 16 (46%) from the control group attended the 2-week, and 3-month follow-up, respectively. The average PSE for participants in the intervention group was significantly higher than that of the control group at the follow-up visit (p = .0050). Readiness to change dietary habits and average PSE for parents in the intervention group were significantly higher than that of the control group after receiving the modified preventive strategy.

Long-term forgetting is independent of age in healthy children and adolescents.

In clinical neuropsychology, the phenomenon of accelerated long-term forgetting (ALF) has advanced to be a marker for subtle but clinically relevant memory problems associated with a range of neurological conditions. The normal developmental trajectory of long-term memory, in this case, memory recall after 1 week, and the influence of cognitive variables such as intelligence have not extensively been described, which is a drawback for the use of accelerated long-term forgetting measures in pediatric neuropsychology. In this clinical observation study, we analyzed the normal developmental trajectory of verbal memory recall after 1 week in healthy children and adolescents. We hypothesized that 1-week recall and 1-week forgetting would be age-dependent and correlate with other cognitive functions such as intelligence and working memory. Sixty-three healthy participants between the ages of 8 and 16 years completed a newly developed auditory verbal learning test (WoMBAT) and the WISC-V intelligence test (General Ability Index, GAI). Using these tests, 1 week recall and 1 week forgetting have been studied in relation to GAI, verbal learning performance, and verbal working memory. Neither 1-week recall nor 1-week forgetting seems to be age-dependent. They are also not significantly predicted by other cognitive functions such as GAI or working memory. Instead, the ability to recall a previously memorized word list after 7 days seems to depend solely on the initial learning capacity. In the clinical setting, this finding can help interpret difficulties in free recall after 7 days or more since they can probably not be attributed to young age or low intelligence.

#1419 A single, easy-to-use question to assess pruritus intensity in daily dialysis practice

Abstract Background and Aims Chronic kidney disease-associated pruritus (CKD-aP) has been shown to negatively impact certain clinical outcomes and quality of life (QoL) in patients with kidney failure. However, regular screening for CKD-aP is not yet routine dialysis practice and no consensus on the preferred instrument exists. To facilitate implementation of regular screening for CKD-aP we assessed the performance of two different instruments validated in patients with CKD-aP. Method The Worst Itching Intensity Numerical Rating Scale (WI-NRS) asks patients to indicate the worst itch intensity in the past 24 hours (range 0 [no itch] to 10 [worst itch imaginable]). The 5-D Itch scale assesses itch-related QoL (range 5-25 where higher values indicate worse QoL) and includes one question on itch intensity over the past 2 weeks (5-D ‘degree’ domain, range 1 [not present] to 5 [unbearable]). Both instruments were included in two phase-3 clinical trials, KALM-1 and KALM-2, that established the favourable benefit-risk profile of difelikefalin over placebo in patients on haemodialysis with moderate to severe CKD-aP. WI-NRS was collected daily during the trial and 5-D Itch at the first dialysis visit in weeks 5, 9, 11 and 13. We assessed the correlations between both the 5-D total score and degree domain and a) the single WI-NRS measurement collected on the same day and b) the average of daily WI-NRS scores collected over the previous 2 weeks in all patients independent of treatment exposure. Results The two instruments demonstrated moderate to strong correlations (range 0.5635-0.7039, p < 0.0001) independent of whether the total 5-D Itch score or the 5-D itch degree question were compared with a single, same-day WI-NRS measurement or with the mean WI-NRS scores over the 2-week recall period of the 5-D Itch (Table). In addition, correlations remained consistent over time, supporting the reliability of the findings. Conclusion Using the WI-NRS to ask patients about their worst itch in the past 24 hours is a simple and swift approach for reliably identifying those with bothersome pruritus that also affects their itch-related QoL.

Pruritus in primary biliary cholangitis is under-recorded in patient medical records

ObjectiveCholestatic pruritus in primary biliary cholangitis (PBC) reduces patients’ health-related quality of life (HRQoL). Despite this, existing research suggests that pruritus is under-recorded in patients’ health records. This study assessed...

Accelerated long-term forgetting in patients with acquired brain injury

ABSTRACT Objective Recent research suggests that patients with neurological disorders without overt seizures may also experience accelerated long-term forgetting (ALF). This term describes unimpaired learning and memory performance after standard retention intervals, but an excessive rate of forgetting over delays of days or weeks. The objective of this retrospective study was to investigate ALF in patients with an acquired brain injury (ABI) and to associate memory performance with executive functions. Methods Verbal memory performance (short-term recall, 30-min recall, 1-week recall) was assessed in 34 adult patients with ABI and compared to a healthy control group (n = 54) using an auditory word learning and memory test. Results Repeated measure analysis showed significant effects of time and group as well as interaction effects between time and group regarding recall and recognition performance. Patients with ABI had a significantly impaired 1-week recall and recognition performance compared to the healthy control group. Correlations between recall performance and executive functions were nonsignificant. Discussion Our results demonstrate that non-epileptic patients with ABI, especially patients with frontal and fronto-temporal lesions, are prone to ALF. Additionally, our data support the assumption that ALF results from a consolidation impairment since verbal recall and recognition were impaired in patients with ABI.

Correlation between oral health and modified OIDP index in pediatric patients undergoing treatment in Clove Dental Clinics: A cross sectional pilot study

ABSTRACT Aim: This research article aims to assess the correlation between oral health and the modified Child Oral Impact on Daily Performance (C-OIDP) index in pediatric patients undergoing treatment at Clove Dental Clinics. The study focuses on evaluating the psychometric properties of the modified C-OIDP index using a Google Forms questionnaire in a multicentric pediatric population across 10 states in India. Materials and Methods: A descriptive cross-sectional study was conducted in two phases among pediatric patients (age range: 2–18 years) undergoing treatment at Clove Dental Clinics in Pan-India. Phase 1: (1) The English version of the C-OIDP index was converted into a pretreatment and posttreatment assessment Google Forms questionnaire. (2) The psychometric and linguistic properties of the modified C-OIDP index were assessed by a panel of experts, incorporating their feedback, and resolving any discrepancies. (3) The modified Google Forms questionnaire was tested on 20 random walk-in pediatric patients visiting two Clove Dental Clinics. (4) Discussions were held with the patients, accompanying guardians, and pedodontists to evaluate their understanding and optimize the questionnaire’s face and content validity. Phase 2: (1) The main study included the reassessment of the modified C-OIDP index using the Google Forms questionnaire on a larger sample of 200 pediatric patients undergoing treatment at Clove Dental Clinics. (2) The questionnaire was administered in both pretreatment and posttreatment scenarios, with a 1-week recall period between assessments. (3) All study participants and their accompanying guardians provided written informed consent. (4) Changes to content wordings during the cultural adaptation process were summarized. Results: (1) A total of 206 voluntary responses were collected from pediatric patients across 341 Clove Dental Clinics in 10 states of India. (2) The factor analysis study revealed good internal consistency reliability and validity of the modified C-OIDP index. (3) The pretreatment and posttreatment modified OIDP scores showed a significant decrease, indicating improved oral health-related quality of life (OHRQoL) posttreatment. Conclusions: The modified C-OIDP index demonstrated good psychometric properties and validity when used in a Google Forms questionnaire among pediatric patients undergoing treatment at Clove Dental Clinics in India. The study highlights the importance of assessing OHRQoL in pediatric populations and provides valuable insights for planning and prioritizing oral health care for children.

Dietary patterns in relation with nutritional outcomes and associated factors among adolescents: implications for context-specific dietary intervention for the Agrarian Community, Northwest Ethiopia.

Dietary pattern analysis allows us to characterize the dietary intakes of individuals rather than nutrient intake data and strongly predicts disease risks. The relationship between food intake and adolescents' nutritional health is not well understood yet. Therefore, this study aimed to generate evidence for context-specific dietary intervention for adolescents. This study aimed to determine dietary patterns and their relationship with nutritional outcomes and identify the contributing factors among adolescents in the Agrarian Community of Northwest Ethiopia. A cross-sectional survey was conducted among 622 randomly selected adolescents. Dietary data were collected over a 1-week recall period using the Food Frequency Questionnaire (FFQ). After testing the basic assumptions, an exploratory factor analysis was conducted to determine the dietary patterns. Anthropometric data on weight and height were collected to determine the nutritional status using WHO Anthroplus 2010 software. A chi-square test was conducted to evaluate the effect of different dietary patterns on nutritional outcomes. A multivariable binary logistic regression model was used to identify factors affecting the dietary patterns of adolescents. Three types of dietary patterns, namely, traditional, mixed, and animal-source foods with traditional alcoholic beverage consumption were identified. These dietary patterns explain 58.64% of the variance in adolescent diet in the study setting. The burden of stunting was 15.12% vs. 11.21, 19.40% vs. 6.94, and 8.36% vs.17.97% among adolescents with lower traditional, mixed, and higher animal sources with alcoholic dietary pattern consumption habits, respectively (value of p <0.05). Adolescents who resided in low-land agroecology (AOR = 2.44; 95% CL: 1.24, 4.81) and had access to animal-source foods (AOR = 1.64; 95% CI: 1.04, 2.60) were associated with lower consumption of traditional dietary patterns. Similarly, adolescents who resided in low-land (AOR = 1.80; 95% CI: 1.18, 2.74) had formal education (AOR = 2.38; 95% CI: 1.35, 4.19) and had poor nutrition knowledge (AOR = 2.83; 95% CL: 1.55, 5.19) were associated with lower consumption of mixed dietary patterns. Moreover, adolescents residing in the high-land (AOR = 2.50; 95% CI: 1.37, 4.56) and being female (AOR =1.87; 95% CI: 1.27, 2.74) were significant factors associated with lower consumption of animal-sourced foods with traditional alcoholic beverage consumption patterns. Multidimensional modifiable factors were explored that could be targeted for public health interventions for the identified dietary patterns. Integrated and multifaceted dietary intervention approaches are needed to promote healthy diets and discourage the consumption of unhealthy diets to reduce undernutrition in the study area and similar settings.

Children of a syndemic: co-occurring and mutually reinforcing adverse child health exposures in a prospective cohort of HIV-affected mother-infant dyads in Cape Town, South Africa.

Several HIV-related syndemics have been described among adults. We investigated syndemic vulnerability to hazardous drinking (HD), intimate partner violence (IPV) and household food insecurity (HFIS) in breastfed children born without HIV in urban South Africa. We compared those who were perinatally HIV exposed (CHEU) to those who were not (CHU), under conditions of universal maternal antiretroviral therapy (ART) and breastfeeding. A prospective cohort of pregnant women living with HIV (WLHIV), and without HIV, were enrolled and followed with their infants for 12 months postpartum (2013-2017). All WLHIV initiated antenatal efavirenz-based ART. Measurements of growth (∼3 monthly), infectious cause hospitalisation, ambulatory childhood illness (2-week recall) and neurodevelopment (BSID-III, measured at ∼12 months' age) were compared across bio-social strata using generalised linear regression models, with interaction terms; maternal data included interview-based measures for HD (AUDIT-C), IPV (WHO VAW) and HFIS. Among 872 breastfeeding mother-infant pairs (n = 461 CHEU, n = 411 CHU), WLHIV (vs. HIV negative) reported more unemployment (279/461, 60% vs. 217/411, 53%; p = 0.02), incomplete secondary education (347/461, 75% vs. 227/411, 55%; p < 0.0001), HD (25%, 117/459 vs. 7%, 30/411; p < 0.0001) and IPV (22%, 101/457 vs. 8%, 32/411; p < 0.0001) at enrolment; and HFIS at 12 months (45%, 172/386 vs. 30%, 105/352; p >0.0001). There were positive interactions between maternal HIV and other characteristics. Compared to food secure CHU, the mean difference (95% CI) in weight-for-age Z-score (WAZ) was 0.06 (-0.14; 0.25) for food insecure CHU; -0.26 (-0.42; -0.10) for food secure CHEU; and -0.43 (-0.61; -0.25), for food insecure CHEU. Results were similar for underweight (WAZ < -2), infectious-cause hospitalisation, cognitive and motor delay. HIV-IPV interactions were evident for ambulatory diarrhoea and motor delay. There were HIV-HD interactions for odds of underweight, stunting, cognitive and motor delay. Compared to HD-unexposed CHU, the odds ratios (95% CI) of underweight were 2.31 (1.11; 4.82) for HD-exposed CHU; 3.57 (0.84; 15.13) for HD-unexposed CHEU and 6.01 (2.22; 16.22) for HD-exposed CHEU. These data suggest that maternal HIV-related syndemics may partly drive excess CHEU health risks, highlighting an urgent need for holistic maternal and family care and support alongside ART to optimise the health of CHEU.

#5300 HUMANISTIC BURDEN OF RARE KIDNEY DISEASES: UNDERSTANDING THE IMPACT OF IGAN AND FSGS ON PATIENTS AND CARE-PARTNERS STUDY (HONUS): A US IGAN RESULTS UPDATE

Abstract Background and Aims While immunoglobulin A nephropathy (IgAN) has been shown to be associated with clinical and economic burden, the humanistic burden associated with IgAN is less understood. HONUS is a multi-national, cross-sectional survey study to evaluate the humanistic burden associated with rare kidney diseases, including IgAN, from the patient and caregiver perspectives in the US and Europe. Method The study recruited adult patients (≥18 years old) with their care-partners and parents/care-partners of youth (8-17 years old) with IgAN or focal segmental glomerulosclerosis (FSGS). Participants completed an online survey with questions on demographic and clinical characteristics, health-related quality of life (HRQoL) (ie, 12-Item Short Form Survey [SF-12]), anxiety and depression (ie, Generalized Anxiety Disorder Assessment [GAD-7], Patient Health Questionnaire [PHQ-9]), most burdensome symptoms, fear and uncertainty for the future, and disease impact on work productivity (ie, Work Productivity and Activity Impairment [WPAI]). The current analysis is based on information from adults with IgAN and their care-partners in the US before September 2022. Descriptive analyses were conducted, with continuous variables summarized using means, medians, and standard deviations (SD), and categorical variables summarized using frequency counts and percentages. Results A total of 96 pairs of adults with IgAN and their care-partners in the US were included in the analysis. The mean age of adult patients was 37.5 and the majority were Caucasian (86.5%) and female (53.1%). Median time since diagnosis was 5.6 years. More than half of patients (59.4%) were in chronic kidney disease stage 3 or 4, while 5.2% were in end-stage renal disease and had received a kidney transplant. Hypertension (31.3%), anemia (25.0%), and depression (18.8%) were the most common comorbidities. In terms of HRQoL, patient's mean (SD) SF-12 physical and mental component scores (PCS, MCS) were reported at 46.9 (7.4) and 41.1 (9.1), respectively, reflecting worse HRQoL (lower score) than previously published US general population scores (PCS and MCS of 50 [10]). Moderate and severe anxiety was reported by 28.1% and 1.0% of patients, respectively; moderate, moderately severe, and severe depression was reported by 51.0%, 2.1% and 1.0% of patients, respectively. The most burdensome symptoms reported by patients were constipation (82.3%), lower back pain (79.2%), and bone or joint pain (77.1%). Based on a 4-week recall period, 25.0% of adult patients reported being ‘very much bothered’ or ‘extremely bothered’ by bone or joint pain (22.9% for lower back pain, 10.4% for constipation). Most patients (96.9%) reported feeling fear and uncertainty for the future due to their disease, of which 52.1% reported the frequency of fear and uncertainty to be ‘often’. Among employed patients (72.9%), percent absenteeism was reported in 6.9%, presenteeism in 27.1%, overall work productivity loss in 31.4%, and activity impairment in 36.2% because of IgAN-related reasons. Most paired care-partners (87.5%) were partners of patients, with a mean age of 39.5 years. The mean SF-12 PCS and MCS of care-partners were 50.4 and 43.6, respectively. Moderate anxiety was reported in 13.5% of care-partners, with none reporting severe anxiety; moderate and moderately severe depression was reported in 35.4% and 5.2% of care-partners, respectively. Almost all care-partners (99.0%) reported feeling fear and uncertainty for the future due to the disease of their cared ones, of which 39.6% reported the frequency of this worry to be ‘often’. Among employed care-partners (93.8%), 9.8% reported absenteeism, 27.3% reported presenteeism, 33.2% reported overall work productivity loss, and 31.9% reported activity impairment due to IgAN-related reasons. Conclusion Patients with IgAN experience impaired HRQoL, depression, anxiety, and poor productivity, compared to previously reported US general population estimates. This also impacts the HRQoL, in terms of mental components, and productivity of care-partners. Both patients with IgAN and their care-partners also report widespread fear and uncertainty for the future.

Effect of full pulpotomy using a calcium silicate–based bioactive ceramic in adult permanent teeth with symptoms indicative of irreversible pulpitis: A retrospective study

BackgroundThe authors studied the treatment effect of full pulpotomy using a calcium silicate–based bioactive ceramic in adult permanent teeth with symptoms indicative of irreversible pulpitis. MethodsEighty-one adult permanent teeth with symptoms indicative of irreversible pulpitis in 78 patients aged 18 through 72 years were evaluated for inclusion in the study. After caries excavation, the pulp was amputated to the level of the canal orifices. After hemostasis was achieved, calcium silicate–based bioactive ceramic was placed as the capping agent. The cavity was sealed temporarily with a glass ionomer cement and then restored with flowable resin and composite resin after 2 weeks if no positive symptoms were reported or detected. Postoperative evaluation was performed by means of clinical and radiographic examination at 2 weeks and 3, 6, and 12 months. ResultsOverall success rates of the procedure were 96.3% (78 of 81), 93.8% (76 of 81), 92.6% (75 of 81), and 92.6% (75 of 81) at the 2-week, 3-month, 6-month, and 12-month recall visits, respectively. Six of the 81 teeth failed and required root canal therapy. In these 6 teeth, 3 exhibited severe cold stimuli pain and spontaneous pain at the 2-week follow-up, 2 had no response to electric pulp testing with apical percussion pain and periapical rarefaction at the 3-month follow-up, and 1 tooth exhibited periapical rarefaction and labial mucosal fistula at the 6-month follow-up. ConclusionsUnder the conditions of this study, full pulpotomy using a calcium silicate–based bioactive ceramic was a successful option for the treatment of adult permanent teeth with carious originated symptoms indicative of irreversible pulpitis. Practical ImplicationsVital pulp therapy is no longer impossible for adult permanent teeth with carious originated symptoms indicative of irreversible pulpitis.

Content validation and psychometric evaluation of the Angioedema Quality of Life Questionnaire for hereditary angioedema

BackgroundThere is considerable burden of illness in hereditary angioedema (HAE). However, instruments to assess health-related quality of life (HRQoL) in HAE are limited. The Angioedema Quality of Life Questionnaire (AE-QoL) was developed to measure HRQoL in patients with recurrent angioedema; the validity of the AE-QoL in patients with HAE is described.MethodsTo identify disease-related experiences with a focus on the impact of HAE on HRQoL, interviews were conducted with a group of clinician experts and patients with HAE from Canada, France, Germany, Spain, the United Kingdom, and the United States, along with a targeted literature review. Concepts were mapped to the AE-QoL to assess item relevance, interpretation, and conceptual coverage. Cognitive interviews assessed item clarity and relevance. A psychometric validation was performed using data from a phase 3 trial.ResultsInterviews were conducted with seven clinicians and 40 adult patients. Patients reported 35 unique impacts of HAE on their lives, the most frequent being on work/school, social relationships, physical activities, and emotions, particularly fear/worrying and anxiety. Saturation for these impacts was reached, and all concepts covered in the AE-QoL were reported during the interviews. Patients agreed that the questionnaire items and response options were clear and relevant, and the 4-week recall period was appropriate. The psychometric validation included data from 64 patients. For AE-QoL total scores, excellent internal consistency (Cronbach’s alpha > 0.90), test-retest reliability (intraclass coefficient > 0.80), convergent validity with the Sheehan Disability Scale (r = 0.663), divergent validity with the EQ-5D-5L index (r = 0.292) and EQ-VAS (r = 0.337), and known-groups validity (p < 0.0001; ɳ2 = 0.56) were demonstrated.ConclusionsQualitative and psychometric analyses showed that the AE-QoL is a reliable and valid instrument for measuring HRQoL in adult patients with HAE from six countries.

The effects of greater frequency of two most prevalent bothersome acute respiratory symptoms on health-related quality of life in the 2020 US general population

PurposeUpper respiratory tract infections (URTI) and related symptoms are widespread and a common reason for visiting primary care with cough and sore throat being most prevalent. Despite their impact on daily activities, no studies have explored the impact on health-related quality of life (HRQOL) in representative general populations. We aimed to understand the short-term impact of the two most prevalent URTI symptoms on HRQOL.MethodsOnline 2020 surveys including acute (≤ 4 weeks) respiratory symptoms (sore throat and cough) and SF-36® health survey (all with 4-week recall) were analysed using analysis of covariance (ANCOVA) in comparison with adult US population norms. Linear T-score transformation of SF-6D utility (ranging from 0 to 1) enabled direct comparisons with SF-36.ResultsIn total, 7563 US adults responded (average age: 52 years; range: 18–100 years). Sore throat and cough lasting at least several days were experienced by 14% and 22% participants, respectively. Chronic respiratory conditions were reported by 22% of the sample. A clear and consistent pattern of group HRQOL means declining significantly (p < 0.001) for acute cough and sore throat symptom presence and severity. Declines were observed on SF-36 physical (PCS) and mental component (MCS) and health utility (SF-6D) scores controlling for covariates. Those reporting respiratory symptoms ‘most days’ declined ≥ 0.5 standard deviation (minimal important difference [MID]) worse with averages at the 19th and 34th centiles for cough on the PCS and MCS, and 21st to 26th centile for sore throat.ConclusionDeclines in HRQOL with acute cough and sore throat symptoms consistently exceeded MID standards and should not be ignored as self-limiting without intervention. Future studies on early self-care for symptom relief and its implications on HRQOL and health economics would be valuable to understand the benefits on healthcare burden and need for updating treatment guidelines.

Content validation of the SF-36v2® Health Survey Acute for use in hypoparathyroidism

PurposeThe purpose of this study was to conduct cognitive debriefing (CD) interviews with adults diagnosed with chronic hypoparathyroidism (HP) to assess the content validity of the SF-36v2® Health Survey Acute (SF-36v2) measure in this population.MethodsCD interviews were conducted with adults with HP in the United States (US). Interviews were conducted by a trained moderator using a semi-structured interview guide, employing a think-aloud method in conjunction with verbal probing. Participants were asked whether each item was understandable, relevant, important, and sensitive to change in relation to HP. Additionally, comprehension of instructions, response options, and the appropriateness of a 1-week recall period was assessed.ResultsSixteen adults with HP participated in individual CD telephone interviews. All items in the SF-36v2 were reported to be understood, relevant, important, and sensitive to change by at least half, and in most cases, by a strong majority of study participants. Most of the study sample confirmed comprehension of the instructions and the entire sample understood all response options.ConclusionThe study findings show that the items in the SF-36v2® are applicable to adults with HP. The overall high levels of endorsement of items provide strong evidence of the measure’s content validity for this population. The SF-36v2 is therefore recommended for usage in clinical trials examining adults with HP, although it is recommended that this generic measure be supplemented with disease-specific instruments such as the recently developed Hypoparathyroidism Patient Experience Scale—Symptom (HPES-Symptom) and Hypoparathyroidism Patient Experience Scale—Impact (HPES-Impact) measures.

The Oxford Elbow Score demonstrated good measurement properties when used with a shortened 7-day recall period

The Oxford Elbow Score (OES) is a well-validated, elbow-specific, patient-reported outcome measure (PROM), originally assigned a 4-week recall period. For PROMs, short recall periods could have some advantages, such as optimizing validity by minimizing the negative effects of inaccurate recollection and temporal trends (increase or decrease) in symptoms over the course of the recall period. Temporal trends in elbow function can, for example, be expected to occur over 4 weeks in patients recovering from an injury or surgery. The purpose of this study was to evaluate the measurement properties of the OES using a shortened, 7-day, recall period (OES-7d). The inclusion criteria were fracture, tendon rupture or dislocation affecting the elbow, and age ≥18 years. Patients with Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) scores of ≥10 points preinjury (pre-existing upper extremity condition) or concurrent upper extremity injuries were excluded. Patients completed the OES-7d, QuickDASH, and Single Assessment Numeric Evaluation-Function for the last 7 days preinjury (T1), the first 7 days postinjury (T2) and a 7-day period 3-5 months postinjury (T3). Correlations were assessed with Spearman's rho. Analyses of construct validity (correlation between scores) and internal consistency (Cronbach's alpha) were based on T3 data. Responsiveness was assessed by correlating changes in scores (change scores) between time points. Intra-rater reliability was assessed by calculating intraclass correlation coefficients based on 2 administrations (1- to 3-week interval) of PROMs in a separate group of patients who had sustained an elbow injury 1-2 years previously. Seventy-five patients (45 women) were included between May 2020 and July 2021. Their mean age was 51.7 years. At T3, Spearman's rho was-0.91 for the correlation between OES total and QuickDASH scores and 0.76 for the correlation between OES total scores and Single Assessment Numeric Evaluation-Function values (construct validity). Spearman's rho for correlation between OES total and QuickDASH change scores from T2 to T3 (T3 minus T2) was-0.85 (responsiveness for improvement) and-0.88 for change scores from T1 to T2 (T2 minus T1, responsiveness for deterioration). For the OES domains, Cronbach's alpha was 0.83 for elbow function, 0.91 for pain and 0.90 for social-psychological domains. The intraclass correlation coefficient for the OES total score was 0.96. The OES demonstrated good measurement properties when used with a 7-day recall period (OES-7d). These results further establish the OES as a well-validated, elbow-specific PROM and support using a 7-day recall period.

Qualitative Research with Patients and Physicians to Assess Content Validity and Meaningful Change on ESSDAI and ESSPRI in Sjögren's.

IntroductionEuropean Alliance of Associations for Rheumatology (EULAR) Sjögren’s Syndrome Disease Activity Index (ESSDAI) is a clinician-reported outcome (ClinRO) instrument, assessing Sjögren’s disease activity from the physician perspective. EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI) is a patient-reported outcome (PRO) instrument, assessing patient-defined Sjögren’s symptom severity. Both instruments are commonly used as clinical trial endpoints and have been psychometrically validated. However, qualitative evidence supporting content validity and what constitutes a meaningful change is limited. Qualitative evidence supporting Physician/Patient Global Assessment of disease activity and symptom severity (PhGA/PaGA) items used within anchor-based analyses for ESSDAI/ESSPRI is also lacking.MethodsQualitative, semi-structured, telephone/video interviews were conducted with patients with Sjögren’s (n = 12) and physicians who specialise in Sjögren’s (n = 10). Interviews explored: appropriateness of ESSDAI domain weights and meaningful improvements on domain/total scores from the physician perspective, appropriateness of ESSPRI’s 2-week recall period from the patient/physician perspective, patients’ perspectives on meaningful improvements in ESSPRI total scores, and patients’/physicians’ interpretation of PhGA/PaGA items.ResultsMost ESSDAI domain weights were considered clinically appropriate. Generally, a one-category improvement in domain-level scores and a 3-point improvement in total ESSDAI scores were considered clinically meaningful. Most patients/physicians considered ESSPRI’s 2-week recall period appropriate, and patients considered a 1-to-2-point ESSPRI total score improvement meaningful. PhGA/PaGA items developed for use as ESSDAI/ESSPRI anchors were consistently interpreted.ConclusionsThe findings support use of ESSDAI and ESSPRI as Sjögren’s clinical trials endpoints, as well as in clinical practice and other research settings. Qualitative data exploring meaningful change supports existing minimal clinically important improvement (MCII) thresholds.

32929 Dupilumab decreases concomitant therapy use in adults with atopic dermatitis (AD): Long-term data from the RELIEVE-AD study

Introduction: Dupilumab is a fully human anti-IL-4Rα monoclonal antibody approved in the US for patients aged ≥6 years with moderate-to-severe AD inadequately controlled by topical therapies. This analysis evaluated the long-term use of concomitant therapy among adult patients treated with dupilumab from RELIEVE-AD, a prospective, longitudinal patient survey conducted in the US. Methods: Adults with moderate-to-severe AD who were prescribed dupilumab but had not yet initiated treatment were recruited to the RELIEVE-AD study from the dupilumab patient support program. Based on a 4-week recall, surveys assessed concomitant AD therapy use, including oral/ injectable steroids, immunosuppressants, and topical medications (steroids, calcineurin inhibitors, crisaborole), at baseline, throughout 1 year after treatment initiation, and at 30-36 months. Results: Of 698 patients completing the baseline survey, 425 (61.0%) responded at Month 30-36. A significant reduction in concomitant AD medication use from baseline was reported across all medication categories assessed: topical use significantly decreased from 81.2% (baseline) to 57.7% (Month 1) and 44.5% (Month 30-36) (both P < .001). Oral steroid use decreased from 30.1% (baseline) to 6.2% (Month 1) and 4.0% (Month 30-36) (both P < .001). Steroid injection treatment decreased from 8.7% (baseline) to 1.7% (Month 1) and 0.9% (Month 30-36) (both P < .001). The proportion of patients reporting no concomitant treatment use significantly increased from 12.8% (baseline) to 39.6% (Month 1) and 54.4% (Month 30-36) (both P < .001). Conclusions: Dupilumab treatment led to a rapid reduction in concomitant medication use that was sustained through 30–36-month follow-up among adults with moderate-to-severe AD.

Editors' Note: Long-term Effect of Regular Physical Activity and Exercise Habits in Patients With Early Parkinson Disease

In “Long-term Effect of Regular Physical Activity and Exercise Habits in Patients With Early Parkinson Disease,” Tsukita et al. reported that regular physical activity, measured by the Physical Activity Scale for the Elderly (PASE) questionnaire, was associated with slower deterioration of postural and gait stability, activities of daily living, and processing speed in patients with early Parkinson disease. Grippe et al. noted that the PASE questionnaire is based on 1-week recall, so it is less reliable than other questionnaires or clinical evaluations of physical activity. They also pointed out that causality in this relationship is unclear because it is possible that postural and gait instability reduces exercise rather than vice versa. Tsukita et al. agreed with these limitations. Both authors emphasized the need for future studies that use other means to evaluate exercise through internet-based applications or other clinical measures. In “Long-term Effect of Regular Physical Activity and Exercise Habits in Patients With Early Parkinson Disease,” Tsukita et al. reported that regular physical activity, measured by the Physical Activity Scale for the Elderly (PASE) questionnaire, was associated with slower deterioration of postural and gait stability, activities of daily living, and processing speed in patients with early Parkinson disease. Grippe et al. noted that the PASE questionnaire is based on 1-week recall, so it is less reliable than other questionnaires or clinical evaluations of physical activity. They also pointed out that causality in this relationship is unclear because it is possible that postural and gait instability reduces exercise rather than vice versa. Tsukita et al. agreed with these limitations. Both authors emphasized the need for future studies that use other means to evaluate exercise through internet-based applications or other clinical measures.

Evaluating construct validity of the Asthma Impairment and Risk Questionnaire using a 3-month exacerbation recall

BackgroundRecurrent assessment of asthma control is essential to evaluating disease stability and intervention impacts. An assessment that can be administered between annual clinic visits is needed. The Asthma Impairment and Risk Questionnaire (AIRQ) is a cross-sectionally validated, 10-item, yes or no, composite control tool evaluating previous 2-week symptoms and previous 12-month exacerbations. ObjectiveTo evaluate the construct validity of the AIRQ using a 3-month recall period for exacerbation-based risk questions and retaining the 2-week recall for symptom-based impairment items. MethodsAt baseline, patients completed the AIRQ with 12-month recall exacerbation items, Asthma Control Test (ACT), St. George's Respiratory Questionnaire (SGRQ), and global self-assessments of asthma risk, control, and symptom severity. Patient-reported exacerbations were captured monthly. The AIRQ with 3-month recall exacerbation items, ACT, and global self-assessments was administered at months 3, 6, and 9, and SGRQ at month 6. ResultsA total of 1112 patients aged 12 years or older were enrolled (mean [SD] age, 43.9 [19.5] years). The AIRQ and each administration of the AIRQ with 3-month recall exacerbation items classified asthma control similarly to an ACT plus exacerbation validation standard. For both AIRQ versions, SGRQ scores were higher with worsening asthma control (P < .001). At months 3, 6, and 9, worse AIRQ control levels were associated with higher proportions of patients with 1 or more and 2 or more exacerbations in the previous 3 months and patient global self-assessments indicating greater asthma morbidity (all P < .001). ConclusionThe AIRQ using exacerbation risk items with a 3-month recall period exhibits construct validity for classifying current asthma control and can be administered between annual AIRQ assessments.

P315 High symptom burden and impact on health-related quality of life in patients with Crohn’s perianal fistulas: results from a global burden of illness study

Abstract Background Perianal fistulas (PAF) are a common complication in Crohn’s disease (CD) and can be associated with an increased burden of illness. A global study was conducted to assess the burden of illness in patients with Crohn’s perianal fistulas (CPF) compared with patients with CD without PAF (non-PAF CD). Here we present patient symptom burden and impact on HRQoL. Methods This cross-sectional study was conducted in seven countries (France, Germany, Spain, UK, Canada, Australia and Japan) in patients aged ≥21 and ≤90 years with self-reported physician-diagnosed CD. Patients were classified as having non-PAF CD (cohort, 1) or CPF without PAF-related surgery (cohort, 2) or CPF with PAF-related surgery (cohort, 3). Customised questions and validated general and disease-specific patient-reported outcome data were collected via a, 45-min IRB/EC-approved web-enabled questionnaire. Symptom burden and impact on HRQoL were evaluated using the Short Inflammatory Bowel Disease Questionnaire (SIBDQ, scores, 1–7 [low–optimum] with, 2-week recall period) in all cohorts and Quality of Life in Patients with Anal Fistula (QoLAF, scores, 14–70 [low–high impact]) in cohorts, 2 and, 3. Data were analysed using descriptive statistics. Results Of, 929 patients recruited (cohort, 1, n=620; cohort, 2, n=174; cohort, 3, n=135), 58–69% were male and, 55–67% were aged, 21–40 years across all cohorts. Cohorts, 2 and, 3 experienced a significantly higher frequency of CD-related complications than cohort, 1 (mean [standard deviation, SD]:, 9.4 [4.5] and, 11.1 [5.2] vs, 6.0 [4.1], respectively; both p &amp;lt;0.05, Table, 1) and had a higher number of CD-related surgeries (other than PAF-related surgeries) in the past, 12 months (mean [SD]:, 1.8 [1.1], p =0.109 and, 2.2 [1.3], p &amp;lt;0.0001 vs, 1.5 [0.9], respectively). In patients with CPF, a smaller proportion in cohort, 2 had active PAF vs cohort, 3 (136 [78%] vs, 119 [88%], respectively; p =0.022) and a smaller proportion had experience with post-treatment PAF recurrence/persistence in cohort, 2 vs cohort, 3 (84 [48%] vs, 80 [59%], respectively; p =0.055). Overall SIBDQ scores were significantly lower (worse) in cohorts, 2 and, 3 than in cohort, 1 (3.8 and, 3.7 vs, 4.1 respectively; both p &amp;lt;0.001). In patients with CPF, total QoLAF scores were comparable between cohorts, 2 and, 3 (41 and, 42, respectively), although patients in cohort, 3 had a significantly higher (worse) score in the physical impact domain compared with cohort, 2 (21 vs, 19, respectively; p &amp;lt;0.05). Conclusion In this large global study, we observed that patients with CPF had incrementally higher symptom burden, owing to both CD and PAF, compared with patients with non-PAF CD. For patients with CPF, there was no difference in HRQoL irrespective of whether they had received PAF-related surgery or not.

P585 Examining faecal incontinence and its impact on health-related quality of life in patients with Crohn’s perianal fistulas: results from a multi-country burden of illness study

Abstract Background Perianal fistulas (PAF) are a common complication associated with Crohn’s disease (CD), and patients with Crohn’s perianal fistulas (CPF) are more likely to experience faecal incontinence (FI) than patients with CD without PAF (non-PAF CD). A global study was conducted to assess the burden of illness in patients with CPF compared with patients with non-PAF CD. Here, we present data on the level of FI and its impact on quality of life (QoL). Methods This cross-sectional study was conducted in seven countries (France, Germany, Spain, UK, Canada, Australia and Japan) in patients aged ≥21 and ≤90 years with self-reported physician-diagnosed CD. Patients were classified as having non-PAF CD (cohort 1) or CPF without PAF-related surgery (cohort 2) or CPF with PAF-related surgery (cohort 3). Validated, general and disease-specific patient-reported outcome data were collected using a 45-min IRB/EC-approved web-enabled questionnaire. The level of FI was evaluated using the Revised Faecal Incontinence Score (RFIS) (1–20 scale, 0 = no incontinence, 4-week recall period) and the impact of FI on QoL in patients who had experienced FI using the Fecal Incontinence Quality of Life (FIQL) (1–5 scale, 1 = lower QoL). Data were analysed using descriptive statistics. Results Of the 929 patients recruited (cohort 1, n = 620; cohort 2, n = 174; cohort 3, n = 135), 58–69% were male and 55–67% were aged 21–40 years across all cohorts. A significantly higher proportion of patients in cohort 3 than cohort 1 had severe Crohn’s disease as classified by a physician (18% vs 9%, respectively; p &amp;lt; 0.05). Overall, 47% of patients reported experiencing FI and completed both the RFIS and FIQL. Significantly higher proportions of patients in cohorts 2 and 3 had experienced FI than in cohort 1 (59% and 59% vs 40%, respectively; p &amp;lt; 0.05), and a significantly higher proportion were currently experiencing FI in cohort 3 than in cohorts 1 and 2 (69% vs 37% and 45%, respectively; p &amp;lt; 0.05). Mean RFIS scores were significantly higher (worse) in cohorts 2 and 3 than cohort 1 (9.5 [p &amp;lt; 0.05] and 10.6 [p &amp;lt; 0.001] vs 8.2, respectively). Patients in cohort 2 had significantly lower (worse) FIQL scores than those in cohort 1 across three FIQL domains (lifestyle [2.2 vs 2.4], depression/self-perception [2.1 vs 2.3], embarrassment [2.2 vs 2.4]; p &amp;lt; 0.05), whereas patients in cohort 3 only reported significantly lower FIQL scores compared with cohort 1 in the embarrassment domain (2.2 vs 2.4; p &amp;lt; 0.05). Conclusion In this study almost half of the patients experienced faecal incontinence. Among those who experienced faecal incontinence, patients with PAF experienced a significantly higher impact on their quality of life compared with patients without PAF.