Patient-reported Outcome Questionnaires Research Articles

Joining telehealth in rheumatology: a survey on the role played by personalized experience from patients’ perspective

BackgroundThe beginning of the Covid-19 pandemic has forced many hospital departments worldwide to implement telehealth strategies for the first time. Telehealth represents the opportunity to increase value for all stakeholders, including patients and healthcare staff, but its success constitutes a challenge for all of them and particularly patients play a crucial role for their needed adherence. This study focuses on the experience of the Rheumatology Unit of Niguarda Hospital in Milan (Italy), where telehealth projects have been implemented for more than a decade with structured design and organized processes. The case study is paradigmatic because patients have experimented personalized mixes of telehealth channels, including e-mails and phone calls, Patient Reported Outcomes questionnaires, and home delivery of drugs. Given all these peculiarities, we decided to deepen patients’ perspective through three main aspects related to the adoption of telehealth: (i) the benefits perceived, (ii) the willingness to enrol in future projects, (iii) the preference on the service-mix between remote contacts and in-person visits. Most importantly, we investigated differences in the three areas among all patients based on the mix of telehealth channels experienced.MethodsWe conducted a survey from November 2021 to January 2022, enrolling consecutively patients attending the Rheumatology Unit of Niguarda Hospital in Milan (Italy). Our survey comprised an introductory set of questions related to personal, social, clinical and ICT skills information, followed by the central part on telehealth. All the answers were analysed with descriptive statistics and regression models.ResultsA complete response was given by 400 patients: 283 (71%) were female, 237 (59%) were 40–64 years old, 213 (53%) of them declared to work, and the disease most represented was Rheumatoid Arthritis (144 patients, 36%). Descriptive statistics and regression results revealed that (i) non-users imagined wide-ranging benefits compared to users; (ii) other things being equal, having had a more intense experience of telehealth increased the odds of accepting to participate to future projects by 3.1 times (95% C.I. 1.04–9.25), compared to non-users; (iii) the more telehealth was experienced, the higher the willingness to substitute in-person with online contacts.ConclusionsOur study contributes to enlighten the crucial role played by the telehealth experience in determining patients’ preferences.

Identifying patient subgroups with different trends of patient-reported outcomes (PROMs) after elective knee arthroplasty

BackgroundPatient-reported outcome measures (PROMs) are increasingly being used to assess the effectiveness of elective total knee arthroplasty (TKA). However, little is known about how PROMs scores change over time in these patients. The aim of this study was to identify the trajectories of quality of life and joint functioning, and their associated demographic and clinical features in patients undergoing elective TKA.MethodsA prospective, cohort study was conducted, in which PROMs questionnaires (Euro Quality 5 Dimensions 3L, EQ-5D-3L, and Knee injury and Osteoarthritis Outcome Score Patient Satisfaction, KOOS-PS) were administered to patients at a single center undergoing elective TKA before surgery, and at 6 and 12 months after surgery. Latent class growth mixture models were used to analyze the patterns of change in PROMs scores over time. Multinomial logistic regression was used to investigate the association between patient characteristics and PROMs trajectories.ResultsA total of 564 patients were included in the study. The analysis highlighted differential patterns of improvement after TKA. Three distinct PROMs trajectories were identified for each PROMs questionnaire, with one trajectory indicating the most favorable outcome. Female gender appears to be associated with a presentation to surgery with worse perceived quality of life and joint function than males, but also more rapid improvement after surgery. Having an ASA score greater than 3 is instead associated with a worse functional recovery after TKA.ConclusionThe results suggest three main PROMs trajectories in patients undergoing elective TKA. Most patients reported improved quality of life and joint functioning at 6 months, which then stabilized. However, other subgroups showed more varied trajectories. Further research is needed to confirm these findings and to explore the potential clinical implications of these results.

Clinical Outcomes of Osteochondritis Dissecans Lesions of the Capitellum Treated with Arthroscopy with a Mean Follow-Up of 8.3 Years.

While numerous studies exist evaluating the short-term clinical outcomes for patients who have undergone elbow arthroscopy for osteochondritis dissecans (OCD) of the capitellum, the literature on minimum 2-year clinical outcomes for a large cohort of patients is limited. /Hypothesis: We hypothesized that clinical outcomes for patients treated arthroscopically for OCD of the capitellum would be favorable, with improved postoperative subjective functional and pain scores, and with acceptable return to play for these patients. A retrospective analysis from a prospectively collected surgical database was performed to identify all patients treated surgically for OCD of the capitellum at our institution from January 2001 to August 2018. Inclusion criteria for this study included the diagnosis of OCD of the capitellum treated arthroscopically with minimum 2-year follow-up. Exclusion criteria included any prior surgical treatment on the ipsilateral elbow, missing operative reports, and patients with any portions of the surgical procedure performed open. Follow-up was performed by telephone using multiple patient-reported outcome questionnaires: American Shoulder and Elbow Surgeons - Elbow (ASES-e), Andrews/Carson, Kerlan-Jobe Orthopaedic Clinic Shoulder and Elbow Score (KJOC), and our institution-specific return-to-play questionnaire. After the inclusion and exclusion criteria were applied to our surgical database, 107 eligible patients were identified. Of these, 90 were successfully contacted for a follow-up rate of 84%. The mean age was 15.2 years and mean follow-up time was 8.3 years. Eleven patients had a subsequent revision procedure for a 12% failure rate in these patients. ASES-e pain was an average of 4.0 out of a max pain scale of 100, ASES-e function was an average of 34.5 out of a maximum of 36, and surgical satisfaction was an average of 9.1 out of 10. The average Andrews/Carson score was 87.1 out of 100 and the average KJOC score for overhead athletes was 83.5 out of 100. Additionally, out of the 87 patients evaluated who played sports at the time of their arthroscopy, 81 (93%) returned to play. This study demonstrated an excellent return-to-play rate and satisfactory subjective questionnaire scores with a 12% failure rate following arthroscopy for OCD of the capitellum with a minimum 2-year follow-up.

Patient-Reported Outcomes as Interradiographic Predictors of Response in Non-Small Cell Lung Cancer.

Minimally invasive biomarkers have been used as important indicators of treatment response and progression in cancers such as prostate and ovarian. Unfortunately, all biomarkers are not prognostic in all cancer types and are often not routinely collected. Patient-reported outcomes (PRO) provide a non-obtrusive, personalized measure of a patient's quality of life and symptomatology, reported directly from the patient, and are increasingly collected as part of routine care. Previous literature has shown correlations between specific PROs (i.e., insomnia, fatigue) and overall survival. Although promising, these studies often only consider single time points and ignore patient-specific dynamic changes in individual PROs, which might be early predictors of treatment response or progression. In this study, PRO dynamics were analyzed to determine if they could be used as interradiographic predictors of tumor volume changes among 85 patients with non-small cell lung cancer undergoing immunotherapy. PRO questionnaires and tumor volume scans were completed biweekly and monthly, respectively. Correlation and predictive analysis were conducted to identify specific PROs that could accurately predict patient response. Changes in tumor volume over time were significantly correlated with dizziness (P < 0.005), insomnia (P < 0.05), and fatigue (P < 0.05). In addition, cumulative changes in insomnia could predict progressive disease with a 77% accuracy, on average 45 days prior to the next imaging scan. This study presents the first time that patient-specific PRO dynamics have been considered to predict how individual patients will respond to treatment. This is an important first step in adapting treatment to improve response rates.

Leukocyte-Poor Platelet-Rich Plasma Injections Improve Cartilage T1ρ and T2 and Patient-Reported Outcomes in Mild-to-Moderate Knee Osteoarthritis

To use T1ρ and T2 magnetic resonance imaging to evaluate the effect of leukocyte-poor platelet-rich plasma (LP-PRP) injections on knee cartilage health and to correlate structural changes with patient-reported outcome measurements. Ten patients with symptomatic unilateral mild-to-moderate knee osteoarthritis (Kellgren-Lawrence Grade 1-2) underwent T1ρ and T2 magnetic resonance imaging of both the symptomatic and contralateral knee before injection and 6 months after injection with LP-PRP. Patient-reported outcome questionnaires (Knee Osteoarthritis Outcome Score and International Knee Documentation Committee) that evaluate the domains of pain, symptoms, activities of daily living, sports function, and quality of life were completed at baseline, 3 months, 6 months, and 12 months after injection. T1ρ and T2 relaxation times, which are correlated with the proteoglycan and collagen concentration of cartilage, were measured in compartments with and without chondral lesions. Ten patients were prospectively enrolled (9 female, 1 male) with a mean age of 52.9 years (range, 42-68) years and mean body mass index of 23.2 ± 1.9. Significant increases in Knee Osteoarthritis Outcome Score for all subscales and International Knee Documentation Committee scores were observed 3 months after injection and the improvements were sustained at 12 months. T1ρ and T2 values of compartments with chondral lesions were observed to significantly decrease by 6.0% (P= .036) and 7.1% (P= .017) 6 months after LP-PRP injection, respectively. No significant associations between T1ρ and T2 relaxation times and improvement in patient-reported outcomes were observed. Patients undergoing LP-PRP injections for the treatment of mild-to-moderate knee osteoarthritis had increased proteoglycan and collagen deposition in the cartilage of affected compartments by 6 months after injection. Patient-reported outcomes scores improved 3 months after injection and were sustained through 1 year after injection, but these improvements were not associated with the changes in proteoglycan and collagen deposition in knee cartilage. Level II, prospective cohort study.

Interaction Between Determinants Governing Urine Volume in Patients With ADPKD on Tolvaptan and its Impact on Quality of Life

Autosomal dominant polycystic kidney disease (ADPKD) is the most prevalent genetic cause of kidney failure. Tolvaptan, a vasopressin 2 receptor antagonist, is the first drug with proven disease-modifying activity. Long-term treatment adherence is crucial, but a considerable fraction of patients discontinue treatment, because of aquaretic side effects. Twenty-four-hour urine was collected in 75 patients with ADPKD during up-titration of tolvaptan and, in combination with clinical characteristics, examined to identify factors influencing urine volume. Patient-reported outcomes were analyzed using the Short Form-12 (SF-12) and patient-reported outcomes questionnaires reporting micturition frequency and burden of urine volume. Initiation of therapy led to a large increase in urine volume followed by only minor further increase during up-dosing. Younger patients and patients with better kidney function experienced a larger relative rise. Twenty-four-hour urine osmolality dropped by about 50% after therapy initiation independently of dose, with a considerable proportion of patients achieving adequate suppression. Sodium and potassium intake turned out to be the only significant modifiable factors for urine volume after multivariate linear regression models, whereas age and weight could be identified as non-modifiable factors. No change in quality of life (QoL) was detected in relation to treatment or urine volume using SF-12 questionnaires, a finding that was further supported by the results of the patient-reported outcomes assessment. This study provides an in-detail analysis of factors associated with the degree of polyuria on tolvaptan and puts them into the context of QoL. These findings will contribute to optimized patient counseling regarding this treatment option in ADPKD.

Association of the AAV-PRO questionnaire with established outcome measures in AAV.

The ANCA-associated vasculitis (AAV) patient-reported outcome (AAV-PRO) questionnaire was developed to capture the impact of AAV and its treatment. We investigated the association of specific AAV-PRO domains with disease activity and extent, damage, depression, health-related quality of life, and treatment. In a prospective longitudinal study, AAV-PRO, Beck's depression inventory (BDI), Short Form 36 (SF-36), BVAS and Vasculitis Damage Index (VDI) were completed at baseline (t1) and after 3-6 months (t2). In addition, patient data (including diagnosis, therapies, relapses, and organ manifestations) were recorded. Data were analysed by t-tests and correlation-based regression analyses. A total of 156 patients with AAV participated. The mean BVAS at the time of enrolment was 1.4 ± 3.74. The median AAV-PRO domain scores were higher in patients reporting 'active disease' compared with those reporting 'in remission' (P < 0.001). In the correlation analyses, all AAV-PRO domain scores correlated strongly with the BDI (all r ≥ 0.319, all P ≤ 0.001) as well as with all eight SF-36 subdomains (all |r|≥0.267, all P ≤ 0.001). The regression analyses showed that AAV-PRO domains were strongly predicted by the BDI and SF-36 domains (|β| ≥ 0.240 for the strongest predictor of each domain). In the longitudinal comparison (t1/t2), there were no significant changes in the overall results. Our data show convergent validity for all AAV-PRO subdomains, using the established questionnaires BDI and SF-36. The AAV-PRO domains scores were not correlated with clinician-derived instruments (including the BVAS and the VDI). Thus, we regard the AAV-PRO questionnaire as a valuable measure of outcomes that might complement traditional end-points in clinical trials.

Quality of Life in Patients with Papillary Thyroid Cancer Assessed with The Turkish Version of The Thyroid Related Patient-Reported Outcome Questionnaire ThyPRO: A Prospective Single Center Study

Searchable abstracts of presentations at key conferences in endocrinology ISSN 1470-3947 (print) | ISSN 1479-6848 (online)

Safety and Feasibility of Hypnosis-Induced Sleep Endoscopy in Obstructive Sleep Apnea Patients.

Hypnosis was never used in sleep endoscopy assessment of obstructive sleep apnea syndrome (OSAS). The aim of the study was to assess the feasibility, safety, and patient satisfaction of hypnosis-induced sleep endoscopy (HISE). From January to July 2021, 24 adults with moderate-to-severe OSAS at the polysomnography were included in the HISE protocol. The following outcomes were evaluated by the otolaryngologist and the hypnotherapist: safety, feasibility, and performance. The patient outcomes were assessed through a patient-reported outcome questionnaire assessing hypnosis acceptance, stress, anxiety, nasofibroscopy examination pain, and discomfort. Twenty-three patients completed the evaluations (16 males). The mean age of patients was 50.8years. The nasofibroscopy was well-tolerated with low levels of stress during the HISE. Otolaryngologist adequately completed the VOTE scoring in 22 patients (95.7%). Hypnosis was ineffective in one patient because he felt pain during the nasofibroscopy procedure due to an important septal deviation. The hypnotherapist reported adequate satisfaction outcomes, with better results for trance compliance compared to other steps. There were no adverse effects or complications. The percentage of snoring was negatively associated with the level of consciousness during hypnosis (p = 0.012). The easiness of nasofibroscopy was positively associated with the levels of muscle relaxation (p = 0.036) and consciousness (P = 0.002). HISE is an effective alternative approach for the work-up of OSAS. Future controlled studies are needed to compare HISE with drug-induced sleep endoscopy and assess the cost-effective outcomes of both approaches.

A Retrospective Matched-Pair Analysis of Long-term Outcomes after Successful Lower Extremity Free Flap Salvage.

Pedicle occlusion with total free flap loss after microvascular lower extremity reconstruction is a considerably rare yet devastating complication. Fortunately, in the majority of cases, emergency salvage takebacks of compromised free flaps are initiated in a timely manner. In this report, we present our analysis of long-term outcomes following transient vascular compromise mitigated through successful free flap salvage in the lower extremity. We performed a single-center retrospective matched-pair analysis of 46 patients with lower extremity free flap reconstructions. Cases underwent successful revisions of microvascular compromise (n = 23), whereas controls had uneventful postoperative courses (n = 23). Patient-reported outcome questionnaires and physical evaluations were used to assess general quality of life, functional outcomes, and cosmesis (Lower Extremity Functional Scale [LEFS], Lower Limb Outcomes Questionnaire [LLOQ], Short Form 36 (SF-36), Vancouver Scar Scale [VSS]). The mean follow-up time was 4.4 years. The health-related quality of life assessed by the SF-36 did not differ significantly between both groups in any of the subscales (p ≥ 0.15 for all subscales). Functional outcomes did not show significant differences between both groups according to the LEFS (p = 0.78) and LLOQ (p = 0.45). The overall scar appearance assessed by the VSS showed significantly poorer cosmesis in the re-exploration group (p = 0.014). Salvage of compromised free flaps in the lower extremity yields similar long-term outcomes compared to noncompromised free flaps with regard to function and quality of life. However, free flap revisions may lead to impaired scar formation. This study provides further evidence that the opportunity for urgent re-exploration is indispensable.

CLINICAL AND RADIOLOGICAL OUTCOMES OF CUSTOM 3D-PRINTED GLENOID COMPONENTS IN PRIMARY AND REVISION REVERSE POLARITY TOTAL SHOULDER ARTHROPLASTY WITH SEVERE GLENOID BONE LOSS: A MINIMUM TWO-YEAR FOLLOW-UP

The purpose of this study is to report the clinical and radiological outcomes of patients undergoing primary or revision reverse total shoulder arthroplasty using custom 3D printed components to manage severe glenoid bone loss with a minimum of 2-year follow-up.After ethical approval (reference: 17/YH/0318), patients were identified and invited to participate in this observational study. Inclusion criteria included: 1) severe glenoid bone loss necessitating the need for custom implants; 2) patients with definitive glenoid and humeral components implanted more than 2 years prior; 3) ability to comply with patient reported outcome questionnaires. After seeking consent, included patients underwent clinical assessment utilising the Oxford Shoulder Score (OSS), Constant-Murley score, American Shoulder and Elbow Society Score (ASES), and quick Disabilities of the Arm, Shoulder, and Hand Score (quickDASH). Radiographic assessment included AP and axial projections. Patients were invited to attend a CT scan to confirm osseointegration. Statistical analysis utilised included descriptive statistics (mean and standard deviation) and paired t test for parametric data.3 patients had revision surgery prior to the 2-year follow-up. Of these, 2/3 retained their custom glenoid components. 4 patients declined to participate. 5 patients were deceased at the time of commencement of the study. 21 patients were included in this analysis. The mean follow-up was 36.1 months from surgery (range 22–60.2 months). OSS improved from a mean 16 (SD 9.1) to 36 (SD 11.5) (p &lt; 0.001). Constant-Murley score improved from mean 9 (SD 9.2) to 50 (SD 16.4) (p &lt; 0.001). QuickDASH improved from mean 67 (SD 24) to 26 (SD 27.2) (p = 0.004). ASES improved from mean 28 (SD 24.8) to 70 (SD 23.9) (p = 0.007). Radiographic evaluation demonstrated good osseointegration in all 21 included patients.The utility of custom 3D-printed components for managing severe glenoid bone loss in primary and revision reverse total shoulder arthroplasty yields significant clinical improvements in this complex patient cohort.

Development and validation of a risk prediction model for diabetic retinopathy in type 2 diabetic patients

To establish a risk prediction model and make individualized assessment for the susceptible diabetic retinopathy (DR) population in type 2 diabetic mellitus (T2DM) patients. According to the retrieval strategy, inclusion and exclusion criteria, the relevant meta-analyses on DR risk factors were searched and evaluated. The pooled odds ratio (OR) or relative risk (RR) of each risk factor was obtained and calculated for β coefficients using logistic regression (LR) model. Besides, an electronic patient-reported outcome questionnaire was developed and 60 cases of DR and non-DR T2DM patients were investigated to validate the developed model. Receiver operating characteristic curve (ROC) was drawn to verify the prediction accuracy of the model. After retrieving, eight meta-analyses with a total of 15,654 cases and 12 risk factors associated with the onset of DR in T2DM, including weight loss surgery, myopia, lipid-lowing drugs, intensive glucose control, course of T2DM, glycated hemoglobin (HbA1c), fasting plasma glucose, hypertension, gender, insulin treatment, residence, and smoking were included for LR modeling. These factors, followed by the respective β coefficient was bariatric surgery (− 0.942), myopia (− 0.357), lipid-lowering drug follow-up < 3y (− 0.994), lipid-lowering drug follow-up > 3y (− 0.223), course of T2DM (0.174), HbA1c (0.372), fasting plasma glucose (0.223), insulin therapy (0.688), rural residence (0.199), smoking (− 0.083), hypertension (0.405), male (0.548), intensive glycemic control (− 0.400) with constant term α (− 0.949) in the constructed model. The area under receiver operating characteristic curve (AUC) of the model in the external validation was 0.912. An application was presented as an example of use. In conclusion, the risk prediction model of DR is developed, which makes individualized assessment for the susceptible DR population feasible and needs to be further verified with large sample size application.

Development and validation of the patient reported outcomes questionnaire of children with asthma in China: A Caregiver's proxy-reported measure.

Research on asthma control levels and quality of life is essential for children with asthma during their growth stage. Therefore, it is necessary to develop a questionnaire that can be used for monitoring and evaluating the disease control effectiveness and quality of life of children with asthma in China and to conduct a preliminary evaluation for its reliability, validity, and discriminative ability. The questionnaire was created through a literature review and qualitative interviews for a targeted population. Based on the previous work, 30 caregivers of children with asthma and 5 experienced pediatricians reviewed and discussed a collection of items. Then, 72 items were screened and selected to form the draft questionnaire. After three rounds of investigation (with 240, 503, and 360 participants, respectively), the final questionnaire was established according to the evaluation results. The structure of the questionnaire was explored through confirmatory factor analysis. Exploratory factor analysis and variability analysis were applied based on the first two rounds of investigation. Reliability, construct validity, and discriminative ability were evaluated based on the third round of investigation. The questionnaire contains 6 dimensions and 34 items, and the total cumulative variance contribution rate was 54.96%; Cronbach's α coefficient was 0.91; the split-half reliability coefficient was 0.75, and the test-retest reliability coefficient was 0.74. The children's age, gender, residence, asthma attack in the last three months, caregivers' education background, and monthly income per caregiver were correlated with patient-reported outcomes of children with asthma. The questionnaire appeared to have good reliability, construct validity, and discriminative ability in children with asthma in China.

What's in it for me?: A value assessment of gynecologic cancer clinical trials for Black women

ObjectiveUnderrepresented groups may be dissuaded from clinical trial participation without perceived value. We therefore comprehensively assessed gynecologic cancer clinical trial protocols for the inclusion of items of value most important to Black individuals. MethodsClinicalTrials.gov was queried for NCI-sponsored gynecologic cancer clinical trials in the US between Jan.1994 and Nov.2021. Pre-specified return of value (ROV) items were abstracted from each protocol. Inclusion proportions were calculated for each ROV item and temporal changes assessed with chi-square tests. Temporality of proportional trends was further assessed by slope and departure from linearity calculations. Results279 gynecologic cancer clinical trials were included. Most commonly trials had first accrual in 2001–2007 (37%) and involved ovarian cancer (48%), phase II studies (53%), and chemotherapy (60%) or targeted therapy (34%). Trials often included ROV items in basic information (99%), medical record information (99%), and imaging (82%). 41% of trials included ROV items in biomarker testing, 20% genetic testing, and 20% in patient-reported outcome questionnaires. Over time, there were significant increases in the proportion of trials that included genetic (3% to 51%; p < 0.001) and biomarker testing (14 to 78%, p < 0.001). Information on lifestyle risk factors was rare (1%). No trials included ROV items in ancestry, how to connect with other participants, or remuneration. ConclusionsGynecologic cancer clinical trials include few design elements that provide high value to Black individuals like lifestyle risk factors, ancestry, and remuneration. In any multi-pronged effort to improve diversity in clinical trial enrollment, inclusion of items valued by Black individuals should be considered.

A shared decision-making tool to support the decision of patients with Lumbar Disc Herniation on whether to undergo surgery: a pilot study

This study aims to develop a decision support tool for patients and surgeons dealing with the uncertainty of surgical outcomes and the expectations of both parties for treating symptomatic lumbar disc herniation (LDH). The study uses a mixed-methods approach with Markov Chains (MC) and Analytic Hierarchy Process (AHP) to predict future health states after surgery for LDH, based on patient-reported outcomes measures (PROMs) and custom weights to each individual PROM and elicited priorities. A case-based analysis of two patients is presented to demonstrate the utility of the model in providing a likely trajectory that priority PROMs will follow over time. The study was conducted under the STROBE guidelines as a post hoc analysis of a large spine outcomes research study conducted in southern Brazil. Data were collected from patients operated between 2006 and 2017 to assess pain, disability, mood, and general health status from the preoperative time point to 1 year after surgery using patient-reported outcome questionnaires. The output of the algorithm represented the chances of surgery fulfilling the expectations of Patients A and B. The results presented by the tool suggest that Patient A will have a considerably higher probability of satisfaction and/or not meeting expectations with surgery than Patient B. The study demonstrates the feasibility and utility of a data-driven decision support tool that takes into account patient preferences and beliefs in generating high-quality decision-making and more utility for long-term outcomes in treating symptomatic lumbar disc herniation.

Effects of drug and hazardous alcohol use on having a detectable HIV viral load: An adherence mediation analysis

ObjectivesPeople living with HIV (PWH) with substance or alcohol use often have unsuppressed plasma HIV viral loads (pVL). The degree to which substance and alcohol use effects on HIV viral suppression are mediated through medication nonadherence is incompletely understood. MethodsWe included PWH prescribed antiretroviral therapy and receiving care at an academic HIV clinic between 2014 and 2018 who completed both patient-reported outcomes (PRO) questionnaires and had subsequent pVL measurements. Measures included assessments of alcohol use (AUDIT-C), drug use (NIDA-ASSIST), and self-reported adherence measured using four different methods. Substances found in bivariate analysis to predict detectable pVL were modeled separately for mediation effects through adherence. We report natural direct (NDE) and indirect effect (NIE), marginal total effect (MTE), and percentage mediated. ResultsAmong 3125 PWH who met eligibility criteria, 25.8% reported hazardous alcohol use, 27.1% cannabis, 13.1% amphetamines, 1.9% inhalants, 5.3% cocaine, 4.5% sedative-hypnotics, 2.9% opioids, and 2.3% hallucinogens. Excellent adherence was reported by 58% of PWH, and 10% had detectable pVL. Except for sedatives, using other substances was significantly associated with worse adherence. Bivariate predictors of detectable pVL were [OR (95% CI)]: amphetamine use 2.4 (1.8–3.2) and opioid use 2.3 (1.3–4.0). The percent of marginal total effect mediated by nonadherence varied by substance: 36% for amphetamine use, 27% for opioid use, and 39% for polysubstance use. ConclusionUse of amphetamines, opioids, and multiple substances predicted detectable pVL. Up to 40% of their effects were mediated by self-reported nonadherence. Confirmation using longitudinal measurement models will strengthen causal inference from this cross-sectional analysis.

Feasibility of a virtual reality intervention targeting distress and anxiety symptoms in patients with primary brain tumors: Interim analysis of a phase 2 clinical trial

PurposeCancer patients experience distress and anxiety when undergoing imaging studies to monitor disease status, yet these symptoms are not always appropriately identified or well-managed. This interim analysis of a phase 2 clinical trial explored feasibility and acceptability of a virtual reality relaxation (VR) intervention for primary brain tumor (PBT) patients at the time of clinical evaluation.MethodsEnglish speaking, adult PBT patients with previous reports of distress and upcoming neuroimaging were recruited between March of 2021 and March 2022. A brief VR session was done within 2 weeks prior to neuroimaging with patient-reported outcomes (PROs) collected before and immediately post-intervention. Self-directed VR use over the next 1 month was encouraged with additional PROs assessments at 1 and 4 weeks. Feasibility metrics included enrollment, eligibility, attrition, and device-related adverse effects with satisfaction measured with qualitative phone interviews.ResultsFifty-five patients were approached via email, 40 (73%) responded and 20 (50%) enrolled (9 declines, 11 screen fails). 65% of participants were ≤ 50 years, 50% were male, 90% were White/non-Hispanic, 85% had good KPS (≥ 90), and most were on active treatment. All patients completed the VR intervention, PROs questionnaires, weekly check-ins, and qualitative interview. Most (90%) reported frequent VR use and high satisfaction and only 7 mild AEs were recorded (headache, dizziness, nausea, neck pain).ConclusionThis interim analysis supports feasibility and acceptability of a novel VR intervention to target psychological symptoms for PBT patients. Trial enrollment will continue to assess for intervention efficacy.Trial RegistrationNCT04301089 registered on 3/9/2020.

Abstract P2-15-03: Impact of radiotherapy on the long-term patient-reported outcomes of immediate breast reconstruction: The UK Brighter

Abstract Introduction: Post-mastectomy radiotherapy (PMRT) is an important component of breast cancer treatment and has been shown to improve overall survival for women with large cancers or node positive disease. The long-term effects of radiotherapy on the outcomes of immediate breast reconstruction (IBR) and how these are perceived from the patients’ perspective, however, are largely unknown. The UK Brighter study aimed to evaluate the long-term impact of PMRT on the patient-reported outcomes of IBR to support informed decision-making. Methods: Women who underwent unilateral mastectomy and/or breast reconstruction for invasive breast cancer or ductal carcinoma in situ (DCIS) in England between 1/4/2008 and 31/3/2009 were identified from National Health Service (NHS) Hospital Episode Statistics (HES), and current contact information for the surviving cohort provided by the NHS Personal Demographic Service. Women were sent a letter inviting them to complete three validated patient-reported outcome questionnaires, the BREAST Q, EQ-5D-5L and ICECAP-A, electronically or by post at a minimum of 12 years following their index surgery. Questionnaires were scored according to developers’ instructions and scores for women who had received PMRT following IBR compared with those who underwent IBR without radiotherapy, in the cohort as a whole and by reconstruction type. Results: 11,977 women were invited to participate of whom 4,207 (35.1%) completed the questionnaires. Some 1,236 (29.4%) underwent IBR with 343 (27.8%) expander/implant (EI) reconstructions, 629 (50.9%) latissimus dorsi (LD) flaps with or without (+/-) an implant, and 264 (21.4%) abdominal flap (AF) reconstructions. Of these, 388 (31.4%) (EI n=79 (20.4%); LD+/-implant n=222 (57.2%); AF n=87 (22.4%) received PMRT. In the cohort overall, women who received PMRT following IBR reported significantly lower ‘Satisfaction with Breasts’ scores at 12 years compared with those who did not receive radiotherapy (PMRT mean 56.4. standard deviation (SD) 21.5 vs. no PMRT mean 61.3, SD 20.5), p&amp;lt; 0.001). However, this difference varied across procedure types. Specifically, the ‘Satisfaction with Breasts’ scores of women receiving PMRT following AF reconstruction were 10.5 points lower than those not receiving PMRT (PMRT mean 60.9, SD 20.2; no PMRT mean 71.4, SD 19.6, p&amp;lt; 0.001). This difference was lower in in women undergoing LD reconstruction (mean with PMRT 54.3, SD 21.1; mean without PMRT 61.6, SD 20.7; p&amp;lt; 0.001). There were no significant differences in women undergoing EI reconstruction (PMRT mean 57.5, SD 23.6, no PMRT mean 53.9, SD 17.7). ‘Physical Well-being’ (chest) scores were also significantly lower in women receiving PMRT following IBR in the cohort overall (PMRT mean 78.7, SD 20.1, no PMRT 83.6, SD 18.6, p&amp;lt; 0.001) but women undergoing AF reconstruction showed the greatest difference in scores (PMRT mean 83.2, SD 17.0 vs No PMRT mean 90.1, SD 15.0, p&amp;lt; 0.001). There were no significant differences in ‘Physical Well-being’ scores for women who underwent EI reconstruction with or without PMRT. ‘Psychosocial Well-being’ scores were lower in women receiving PMRT after IBR (PMRT mean 70.8, SD 22.0, No PMRT 75.4, SD 21.0), but again, differential effects were seen by procedure type with no significant differences seen in the EI group but significant differences in scores seen in women receiving PMRT after flap-based procedures. Conclusions: Women undergoing PMRT report significantly lower long-term patient-reported outcomes of flap-based reconstruction, in particular ‘Satisfaction with Breasts’ and ‘Physical Well-being’ scores. This difference was not apparent in women undergoing EI procedures. This information should be shared with patients to help them make fully informed decisions about the type and timing of their reconstructive surgery. Citation Format: Leigh Johnson, Paul White, Ranjeet Jeevan, John Browne, Carmel Gulliver-Clarke, Joe O’Donoghue, Syed Mohiuddin, William Hollingworth, Patricia Fairbrother, Mairead MacKenzie, Chris Holcombe, Shelley Potter. Impact of radiotherapy on the long-term patient-reported outcomes of immediate breast reconstruction: The UK Brighter [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P2-15-03.

Development of a Conceptual Model of the Patient Experience in Small Cell Lung Cancer: A Qualitative Interview Study.

Small cell lung cancer (SCLC) is a subtype of lung cancer, the second most common cancer diagnosis worldwide. Currently, there is little published qualitative research that provides insight into the disease-related symptoms and impacts that are relevant to patients living with SCLC as directly reported by patients themselves. This qualitative, cross-sectional, noninterventional, descriptive study included concept elicitation interviews with participants diagnosed with SCLC and the development of a conceptual model of clinical treatment benefit. Concept elicitation interview data from 26 participants with SCLC were used to develop a conceptual model of clinical treatment benefit that organized 28 patient-reported concepts into two domains: disease-related symptoms (organ-specific and systemic) and impacts. Organ-specific symptoms included cough, chest pain, and difficulty breathing. Systemic symptoms included pain, fatigue, appetite loss, and dizziness. Impacts included physical functioning, role functioning, reduced movement, impact on sleep, and weight loss. As evidenced by this study, people with SCLC experience considerable and significant symptoms and impacts, including physical and role functioning challenges, that affect their quality of life. This conceptual model will inform the design of a patient-reported outcome (PRO) questionnaire for a future SCLC clinical trial, helping to establish the content validity of the items and questionnaires used in the trial and ensuring that the questionnaires and items selected are appropriately targeted to the population. This conceptual model could also be used to inform future SCLC clinical trials.

The minimal clinically important difference of the Southampton Dupuytren’s Scoring Scheme

The minimal clinically important difference (MCID) for patient-reported outcome questionnaires is important in the interpretation of outcome in clinical and research settings. MCID represents the smallest difference in score that the patient would identify as important. There is, to our knowledge, no reported MCID value for Southampton Dupuytren’s scoring scheme (SDSS). The SDSS is a 5-item 20 points scale, where 0 is considered no discomfort or physical limitations and 20 is the worst possible discomfort and physical limitations. The aim of this study was to determine the MCID for the SDSS. The study population consisted of 192 patients, in a prospective period from 2018 to 2021. All patients completed baseline SDSS questionnaires and again at 6 months follow-up with an external anchor question added. We calculated the mean change in scores of SDSS and used the anchor-based approach as well as a distribution-based method to calculate the MCID. At 6 months 163/192 (85%) of the patients were satisfied with the treatment according to the anchor question. In conclusion, the MCID of the SDSS for patients receiving treatment for DD is 1.5 points when estimated by an anchor-based approach and 1.62 points when estimated by a distribution-based approach. These MCID values should be considered in the interpretation of SDSS scores in the future, as well as when planning future studies on DD.