Quality Of Life Outcome Measures Research Articles

Stable fixation of an ultra-short femoral neck-preserving hip prosthesis: a 5-year RSA, DXA, and clinical prospective outcome study of 48 patients.

We previously showed promising primary stability and preservation of bone stock with the ultra-short neck-loading hip implant in total hip arthroplasty (THA). The aim of this study was to evaluate clinical outcome, implant stability, and bone mineral density (BMD). 50 patients were treated with the ultra-short neck Primoris hip implant at baseline and 48 were available for evaluation at 5-year follow-up. 5 different patient-reported outcome measures (PROMs) including hip-specific scores, disease-specific and generic quality of life outcome measures, and an activity score were used. Furthermore, implant stability using radiostereometric analysis (RSA) and assessment of periprosthetic BMD using dual-energy X-ray absorptiometry (DXA) were applied. By 1-year follow-up, all PROMs showed improvements and remained high at 5-year follow-up. After initial distal translation (subsidence) and negative rotation around the z-axis (varus tilt) the implant showed stable fixation at 5-year follow-up with no further migration beyond 12 months. In the regions of interest (ROI) 3 and 4, BMD remained stable. In ROI 2, further bone loss of 12% was found at 5-year follow-up. Clinical outcome including PROMs was satisfying throughout the 5-year follow-up period. The hip implant remains stable with both bone preservation and loss 5 years after surgery.

Long-term safety and effectiveness of canakinumab in patients with monogenic autoinflammatory diseases: results from the interim analysis of the RELIANCE registry

ObjectiveInterim analysis of the RELIANCE registry, an on-going, non-interventional, open-label, multicentre, prospective study evaluating the long-term safety, dosing regimens and effectiveness of canakinumab in patients with cryopyrin-associated periodic syndromes (CAPS),...

Parent-proxy pediatric CMT quality of life outcome measure: Validation of the Italian version.

The parent-proxy reports can offer complementary informations or be the only source of Quality of Life measurement in young children. The aim of this study was to provide and validate the Italian version of the recently published parent-proxy pCMT-QOL for patients aged 8-18 years old, making it available for possible trials in Italian speaking children. The English-language instrument was translated and adapted into the Italian language using standard procedures: translation, transcultural adaptation, and back-translation. Parent-proxy pCMT-QOL was administered to parents of patients with a genetic diagnosis of CMT, aged 8-18 years old. All parents were retested 2 weeks later to assess reliability. A total of 21 parents of CMT patients (18 CMT1A, 2 CMT2A, 1 CMT2K) were assessed during their children clinical appointments. The Italian-pCMT-QOL showed a high test-retest reliability; none of the parents had any difficulties with the completion of the questionnaire and no further revisions were necessary after completion. The Italian parent-proxy pCMT-QOL is a reliable, culturally adapted, and comparable version of the original English instrument. This questionnaire will improve the quality of the follow-up and will make it possible to monitor more accurately the severity of the disease in Italian-speaking families.

CareMENS : a new model of care for elderly at risk of dementia, applied in 7 swiss memory clinics

AbstractBackgroundFourty percent of modifying factors explain cognitive decline in elderly, such as a lack of social and physical activities (Livingston 2020). Speech, physical and neuropsychological therapies have shown efficiency, although stopping them can have an impact on quality of life (Leidi, 2020). Therefore, usual models of care need to evolve to build bridges between therapies and community activities. The aim of CareMENS ( = Care, MEmory and NeuroScience), a new model, is to provide a continuity in patients’ care after the therapies, by assisting them to find a leisure activity in their community in order to stay active and socially involved (Annexe).SettingSeven Memory clinics in the french speaking part of Switzerland.Main outcome measuresQuality of life (WHOQOL), cognition (MoCA), severity of symptoms (CDR), autonomy in daily life activities (DAD‐6), anxiety and depression (HAD), satisfaction (self‐assessed questionnaire).MethodTo meet the needs of patients at risk of dementia and according to their symptomatology, they undergo speech, physical or neuropsychological therapy within a Memory clinic. Then, a care manager organize with the patient a leisure activity in the community to perpetuate the therapies’ benefice and to stay socially involved. Paired‐sample t‐tests were conducted between 2 measures: before therapy and after 3 months of leisure activity.ResultAmong 150 patients that started a therapy within CareMENS (Neuropsychology: n = 94, speech:n = 26, physical: n = 30), 100 completed their therapy, 61 already integrated a community activity and 31 ended the follow‐up. Results are reported for 25 patients. In a mean follow‐up time of 366 days, autonomy remained stable (p = 0.14), whereas global cognition decreased significantly (p = 0.01). Among anxious people, level of anxiety decreased significantly (p = 0.02). Global QOL was stable in patients (p = 0.15) and caregivers (p = 0.46), while the QOL’s dimension of “social participation” improved strongly and significantly in patients (p = 0.0001). Satisfaction to the care manager’s interventions and to the therapies were very encouraging (83.5%).ConclusionCareMENS is a new model of care that give a high satisfaction to patients and caregivers, improves the social dimension of quality of life and integrate patients in the society through community activities, that are enjoyable therefore sustainable.

Measuring population health and quality of life: Developing and testing of the significant quality of life measure (SigQOLM)

Quality of life (QOL) should ideally be determined by a broader spectrum of measurable parameters. This study aims to develop and validate a study instrument that is designed to determine a holistic measure of health and non-health aspects of QOL, and it is called the ‘Significant Quality of Life Measure’ (SigQOLM). This study involves five phases which aim to (i) explore and understand the subject matter content, (ii) develop a questionnaire, (iii) assess its content validity and face validity, (iv) conduct a pilot study, and lastly (v) perform a field-test by using the questionnaire. For the field-testing phase, a cross-sectional study was conducted which elicited responses from healthcare workers via a self-administered survey for all the SigQOLM items. Based on the results, the overall framework of the SigQOLM consists of four elements, 18 domains with 69 items. The element of “Health” is measured by nine domains, while “Relationships”, “Functional activities, and “Survival” are measured by three domains respectively. The SigQOLM has been developed successfully and then validated with a high level of reliability, validity, and overall model fit. Therefore, the SigQOLM will provide researchers and policymakers another viable option to elicit a more comprehensive outcome measure of QOL which shall then enable them to implement specific interventions for improving the QOL of all the people, both healthy or otherwise.

Abstract 13728: Generation of a Patient-Reported Outcome Measure of Quality of Life in Heart Valve Disease

Introduction: Heart valve disease (HVD) is common globally, yet there is no questionnaire measuring quality of life (QOL) across the lifespan of HVD. This limits assessment of changes in QOL in response to intervention in HVD. Research Question: What are all features of QOL in lived HVD, and how may these be best selected between to create a well-performing questionnaire? Goal: We aimed to generate a patient-reported outcome measure of QOL in common and significant types of HVD: aortic stenosis, mitral regurgitation, mitral valve disease in rheumatic heart disease, and valve repair/replacement. Methods: Participants were recruited from echocardiographic databases in two tertiary surgical centres in three phases. Phase One described QOL in interviews; Phase Two pilot-tested the questionnaire; and Phase Three selected between items using item distributions, exploratory factor analysis (EFA), and item response theory (IRT) to create the final questionnaire, called the Valve Quality of life (VALVQ). Results: In Phase One, 34 people with HVD, three family members, and five clinical experts were interviewed. Key features of QOL were physical capacity relative to ‘normal’, symptom interpretation causing reduced activity, and fatigue. In Phase Two, we showed in 62 participants that the resulting questionnaire - and its semantic differential item format - was functional. In Phase Three, 290 participants returned questionnaires. Items were removed for poor distributions, then EFA identified ‘physical capacity’ and ‘disease perception’ as key factors. A two-parameter Graded Response Model was used to generate the final 12-item VALVQ, which is shown in the attached table. Conclusion: Through application of sequential analyses across three phases, we generated the final 12-item VALVQ. It has two factors - physical capacity and disease perception - and can be deployed for future research on QOL in HVD, whether before or after intervention and across multiple forms of HVD.

Health-Related Quality of Life Outcome Measures in Individuals With Hereditary Hemorrhagic Telangiectasia: A Scoping Review.

Studies evaluating health-related quality of life (HRQOL) in patients with hereditary hemorrhagic telangiectasia (HHT) have expanded rapidly in the past decade. These studies have evaluated QOL aspects ranging from the general QOL for patients living with HHT to intervention-specific outcomes. However, few tools have been fully validated across the spectrum of disease manifestations and interventions in HHT. In this scoping review, we aim to map the literature on HHT-QOL metrics, identify gaps, inform future QOL research, and facilitate future metric development. We analyzed articles in English that assessed at least 1 measure of general HRQOL, including physical health, mental health, social health, or intervention-specific QOL in patients with HHT. Searches across 2 bibliographic databases (PubMed and Scopus) yielded 186 articles after duplicates were removed. Sixty-three studies met eligibility criteria: 22 prospective studies (34.9%), 20 retrospective studies (31.7%), 12 cross-sectional studies (17.5%), 6 randomized controlled trials or secondary analyses of a randomized controlled trials (9.5%), 2 qualitative studies (3.2%), and 1 case-control study (1.6%). Two additional studies-1 prospective and 1 cross-sectional study-were identified at the October 2022 14th International HHT Conference and included, making a total of 65 studies. The 65 eligible studies used 30 QOL instruments. Twenty studies characterized baseline HRQOL, and 45 studies evaluated QOL before and after treatment. Of those 45 studies, 37 evaluated HRQOL before and after therapies targeting epistaxis and nasal symptoms, 4 targeted therapies for liver arteriovenous malformations and high-output heart failure, 3 evaluated therapies for both epistaxis and gastrointestinal bleeding, and 1 evaluated treatment targeting gastrointestinal bleeding alone. Comparison of results across studies remains challenging given the heterogeneity in outcomes measures. Further development of HHT-specific patient-reported outcomes instruments that capture the global illness experience of HHT is needed.

Improvement in quality of life among women and men aged 60 years and older following treatment for alcohol use disorder.

Previous studies have yielded mixed results on the association between gender and alcohol use disorder (AUD) treatment outcomes. Thus, additional research is needed to determine the effect of gender on AUD treatment outcomes, including quality of life (QoL), particularly among older adults. In a clinical sample of older adults with DSM-5 AUD, we examined changes in QoL from the beginning of AUD treatment through 1 year of follow-ups. We also examined the effect of gender and explored interaction effects with gender on QoL. We utilized data from the "Elderly Study," a multi-national, single-blind, randomized, controlled trial of 693 adults aged 60+ with DSM-5 AUD. Alcohol use was assessed with the Form-90, and QoL with the brief version of the World Health Organization QoL measure. Information was collected at treatment initiation and at 4-, 12-, 26-, and 52-week follow-ups. Multilevel mixed-effects logistic and linear regression models were used to examine QoL changes and the effect of gender on changes in QoL. Following treatment, small, but significant improvements were seen over time in overall perceived health (p < 0.05). Improvements that persisted over the 1-year follow-up period were seen in the QoL domains of physical health (β: 2.6, 95% CI: 1.4-3.9), psychological health (β: 3.5, 95% CI: 3.3-3.8), social relationships (β: 4.0, 95% CI: 2.5-5.6), and environmental health (β: 1.4, 95% CI: 0.4-2.4). No significant changes were seen over time in overall perceived QoL (p = 0.58). Gender was not associated with changes in any of the QoL outcome measures (all p ≥ 0.05). Among 60+ year-old adults receiving treatment for DSM-5 AUD, improvements in QoL were achievable and maintained over time, but were not associated with gender.

Impact of Infusion Therapies on Quality of Life in Advanced Parkinson's Disease.

A high burden of motor and non-motor parkinsonian symptoms is known to have a significant negative impact on the quality of life (QoL) of people with Parkinson's disease (PD). Effective control of these symptoms with therapies that enable patients to maintain a good QoL is therefore a key treatment goal in PD management. When symptom control can no longer be accomplished with oral or transdermal PD treatment regimens, device-aided therapies (DAT), namely levodopa and apomorphine infusion therapies, and deep brain stimulation, are valuable options to consider. DAT options may also help reduce pill burden and thereby improve compliance with treatment. Since PD therapy relies on symptomatic management, the efficacy and tolerability of any intervention is undoubtedly important, however the impact of different therapies on patient-related outcome measures, in particular health-related QoL, is also a critical consideration for those living with a chronic and disabling condition. This review discusses clinical evidence and ongoing research regarding the QoL benefits of levodopa and apomorphine infusion therapies from studies that have used validated QoL outcome measures. The data suggest that timing of these interventions is important to achieve optimal treatment effects, and that early initiation onto infusion therapies at the point when motor fluctuations emerge, and before patient QoL and functioning have significantly declined, may provide the best long-term outcomes. Healthcare professionals caring for people with PD should therefore discuss all available DAT options with them at an early stage in the course of their disease so they can make informed and timely choices that best suit them, their families and care network.

Health-related quality of life, functional outcomes, and complications after sentinel lymph node biopsy and elective neck dissection in early oral cancer: A systematic review.

Elective neck dissection improves survival in early oral cancer. Sentinel lymph node biopsy may also do this with less morbidity. This systematic review compared health-related quality of life, functional outcomes, and complications after sentinel lymph node biopsy and elective neck dissection in early oral cancer. PRISMA guidelines were followed. Thirteen studies met inclusion criteria. Results favoring sentinel lymph node biopsy were found in complications, scar length and appearance, length of hospital stay, time to drain removal, and objective shoulder measures at timepoints up to 12 months. Where differences in health-related quality of life were found, methodological issues make their clinical significance questionable. Sentinel lymph node biopsy was associated with fewer complications and statistically better outcomes in a number of physical measures. There is as yet no strong evidence to suggest it is associated with better health-related quality of life outcomes. While a number of health-related quality of life outcome measures show promise, their interpretation is hampered by methodological concerns. Further rigorous research is required to address this.

Long-Term Follow-Up of Open Gustilo-Anderson IIIB Fractures Treated With an Adjuvant Local Antibiotic Hydroxyapatite Bio-Composite.

Background Open fractures associated with significant tissue loss are complex and present challenges in management; they are associated with poor outcomes such as infection, non-union or amputation. This study aimed to evaluate outcomes of using an adjuvant local antibiotic hydroxyapatite bio-composite in the management of open Gustilo-Anderson IIIB fractures with up to eight years of follow-up. Methods This was a retrospective study.A total of 81 patients with Gustilo-Anderson IIIB fractures treated with "fix and flap" limb reconstruction with adjuvant local antibiotic therapy using a bio-composite carrier were reviewed. Results The mean follow-up time for all the patients, at the time of data collection, was 55.8 months. Union was achieved in 96% with a limb salvage rate of 96.3% and a deep infection rate of 3.7%. Conclusion The use of local antibiotic therapy, together with a combined orthoplastic "fix and flap" approach for Gustilo-Anderson IIIB open fractures, was found to be associated with a very low rate of metalwork infection and high union and limb salvage rates. Future studies shouldinclude some functional and quality of life outcome measures to see the efficacy of this method.

Sounding the Alarm: What Clinicians Need to Know about Physical, Emotional, and Cognitive Recovery After Venoarterial Extracorporeal Membrane Oxygenation.

We summarize the existing data on the occurrence of physical, emotional, and cognitive dysfunction associated with postintensive care syndrome (PICS) in adult survivors of venoarterial extracorporeal membrane oxygenation (VA-ECMO). MEDLINE, Cochrane Library, EMBASE, Web of Science, and CINAHL databases were searched. Peer-reviewed studies of adults receiving VA-ECMO for any reason with at least one measure of health-related quality of life outcomes or PICS at long-term follow-up of at least 6 months were included. The participant demographics and baseline characteristics, in-hospital outcomes, long-term health outcomes, quality of life outcome measures, and prevalence of PICS were extracted. Twenty-seven studies met inclusion criteria encompassing 3,271 patients who were treated with VA-ECMO. The studies were limited to single- or two-center studies. Outcomes variables and follow-up time points evaluated were widely heterogeneous which limits comprehensive analysis of PICS after VA-ECMO. In general, the longer-term PICS-related outcomes of survivors of VA-ECMO were worse than the general population, and approaching that of patients with chronic disease. Available studies identified high rates of abnormal 6-minute walk distance, depression, anxiety, and posttraumatic stress disorder that persisted for years. Half or fewer survivors return to work years after discharge. Only 2 of 27 studies examined cognitive outcomes and no studies evaluated cognitive dysfunction within the first year of recovery. No studies evaluated the impact of targeted interventions on these outcomes. Survivors of VA-ECMO represent a population of critically ill patients at high risk for deficits in physical, emotional, and cognitive function related to PICS. This systematic review highlights the alarming reality that PICS and in particular, neurocognitive outcomes, in survivors of VA-ECMO are understudied, underrecognized, and thus likely undertreated. These results underscore the imperative that we look beyond survival to focus on understanding the burden of survivorship with the goal of optimizing recovery and outcomes after these life-saving interventions. Future prospective, multicenter, longitudinal studies in recovery after VA-ECMO are justified.

Quality of life of children and young people with anterior chest wall deformity: a systematic review of the literature

ObjectiveThe aim of this study was to evaluate the current evidence regarding the quality of life (QoL) of children and young people with anterior chest wall deformity (ACWD).MethodsUsing a defined...

Patient- and Caregiver-Reported Outcome Measures after Single-Level Selective Dorsal Rhizotomy in Pediatric and Young Adult Patients with Spastic Cerebral Palsy

Introduction: The aim of this cohort study was to assess the outcome of single-level selective dorsal rhizotomy (SDR) in children and young adults with spastic cerebral palsy (CP) treated at our institution, focusing on patient-reported outcome measures (PROMs) and quality of life (QoL) of patients and their caregivers. Methods: We included consecutive patients undergoing SDR from 2018 to 2020 at our institution. Subjective outcome was measured through PROMs, while functional outcome was measured through baseline characteristics, operative outcome, as well as short- and long-term follow-up. Furthermore, the effect of age at the time of surgery on patient/caregiver satisfaction was analyzed. Results: Seven patients (3 female, 43%) with a median age at surgery of 11.9 years (IQR 8.7–15.5) were included. All patients had a Gross Motor Function Classification (GMFCS) score of at least IV before surgery. Five surgeries were palliative and two non-palliative. Based on PROMs, SDR showed very good QoL and health-related outcome measures for both palliative and non-palliative patients. Patient/caregiver satisfaction was higher for the early subgroup (age ≤11) than the late subgroup (age >11). Functional outcome showed reduced spasticity in both groups. Blood transfusions were never needed, while no cerebrospinal fluid leak, infection, or permanent morbidity was seen. Conclusion: Based on PROMs, SDR leads to high satisfaction and improved QoL, especially if done at an early age. Further studies with larger cohorts are necessary to underline and confirm our observations.

The Impact of Fertility Goals on Long-term Quality of Life in Reproductive-aged Women Who Underwent Myomectomy versus Hysterectomy for Uterine Fibroids

Study ObjectiveThe objective of this study is to compare quality of life (QOL) for myomectomy with hysterectomy 1 to 5 years after surgical management for fibroids. This study evaluated the difference in QOL in a population of women of reproductive age, including those who desire fertility. DesignA retrospective cohort study. InterventionsNot applicable. SettingA large academic hospital. PatientsA total of 142 women who underwent hysterectomy or myomectomy in 2015 to 2020. Included patients were women aged 18 years or older who underwent surgical intervention owing to uterine fibroids. Measurements and Main ResultsThe 36-Item Short Form Health Survey (SF-36) provides a total score as a single measure of health-related QOL. The Uterine Fibroid Symptom Quality of Life Questionnaire for Hysterectomy and Myomectomy (UFS-QOL) is a patient-reported outcome measure of fibroid symptoms and health-related QOL after hysterectomy and myomectomy. There was no significant difference in SF-36 QOL scores in women after myomectomy who desired fertility compared with those who did not desire fertility, except in the social functioning domain (p = .025). UFS-QOL scores in women after myomectomy who desired fertility were not significantly different compared with women after myomectomy who did not desire fertility (p = .37). There were no significant differences between women who underwent myomectomy and hysterectomy in overall QOL scores on the SF-36 (p = .13) and UFS-QOL scores (p = .16). ConclusionMyomectomy is not associated with significant differences in measures of general health and QOL compared with hysterectomy, making it a viable fibroid management option for women who desire fertility. Our study highlights the importance of discussing fertility goals and QOL when counseling patients for surgical fibroid treatment.

Investigating trial feasibility of music care in hospice and palliative care

The nature of hospice and palliative care (HPC) settings necessitates supporting residents’ ever-changing needs and responding to unforeseeable situations – as such, this unpredictability has historically challenged the collection of high-quality data in such settings. Through a feedback consensus approach, this pilot study sought to determine the feasibility of implementing a clinical trial aiming to understand the impact of a recorded music care intervention on quality of life (QoL) in HPC settings. Four participants with a palliative performance scale (PPS) score of ≥ 40 were recruited. Pre-developed music care albums designed for HPC were used as an intervention for a minimum duration of 30-minutes. The Edmonton Symptom Assessment Scale, Hospice Quality of Life Index, and State-Trait Anxiety Inventory were implemented to mirror a future randomised controlled trial (RCT) design but were not statistically interpreted in this pilot study. Data collectors also recorded participants’ and care providers’ perspectives. Through feedback from participants, healthcare professionals, and music care experts, the intervention duration was reduced to a minimum of 15-minutes, and the PPS inclusion criteria requirement was eliminated. The number of outcome measures was reduced from three to one to mitigate participant burnout. Finally, participants indicated that the recorded music intervention was therapeutic, therefore justifying further study of QoL outcome measures. Implementing a second pilot to validate the changes to the RCT study protocol will be a critical step in the research process, although the results of this study can be considered by researchers conducting RCTs in HPC to inform best practices.

Simultaneous integrated boost (SIB) stereotactic body radiotherapy (SBRT) for prostate and pelvic nodes in high risk, node positive and oligometastatic prostate cancers: Safety, efficacy and quality of life outcome measures.

121 Background: SBRT in high risk (HR), node positive (N+) and oligometastatic (OM) prostate cancers is limited by pelvic nodal coverage, larger treatment volumes and use of hormone therapy. We report the safety, efficacy and patient reported quality of life measures (QOL) for SIB-SBRT for prostate and pelvic nodal treatment in HR, N+ and OM (non-regional node or skeletal deposits) cohorts. Methods: 22 patients of NCCN category HR, N+, OM adenocarcinoma prostate and all staged by MRI prostate and PSMA PETCT scan received SIB-SBRT from April 2019 to October 2021. All received long term androgen (ADT) deprivation therapy (80%) or surgical castration (20%). ADT was neo-adjuvant, concomitant and adjuvant for at least 2 years and for OM 2nd generation hormone treatment. SIB-SBRT to prostate and pelvic nodal regions (until common iliac level) was 35-36.25 Gy and 25 Gy in 5 fractions respectively. Post ADT gross PSMA avid nodes and skeletal deposits received 30 Gy in 5 fractions. SIB-SBRT was by volumetric modulated arc therapy (VMAT) with intrafraction imaging and hexapod robotic couch corrections on alternate days. Baseline IPSS and Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) QOL recorded and then post SIB-SBRT at 6 weeks and then 3 monthly till 2 years. Dosimetry followed standard published literature. Results: 22 patients were treated over 3 years with median age of 70 years. The median PSA at baseline was 45ng/ml with 90% Gleason score 8+. The OM disease included nonregional nodes or 1-2 skeletal deposits. After median follow up of 20 months acute grade 2 genitourinary (GU) and gastrointestinal (GI) toxicities were 10% and 12%, respectively. Late grade 2 GU and GI toxicities were 4% and 9%, respectively. Late grade 3 GU and GI toxicity was seen in 2 patients each requiring medical management. 2- year overall survival and biochemical failure-free survival was 95% and 90% respectively. Baseline median IPSS score was 9 and median EPIC CP score was 12/60. Mean urinary incontinence domain scores worsened significantly from baseline to 6 months and obstructive scores improved from baseline to 6 months with more than 95% patients not using any pads at 6 months. Bowel frequency scores were maximum at 6 weeks post SBRT and it persisted till 6 months. Sexual function scores declined gradually and recovered only in a few at last follow up. Vitality/hormonal scores were unchanged from baseline till 6 months. Conclusions: SIB-SBRT for HR, N+ and OM prostate cancers is safe and effective, with good QOL. The encouraging PSA control and minimal grade 3 toxicity and favorable therapeutic ratio achieved reflect the feasibility of LINAC based SIB-SBRT. This warrants long term follow-up with effective bladder/rectal protocol measures and optimal use of ADT in a prospective setting.

Comorbidity and health-related quality of life in people with a chronic medical condition in randomised clinical trials: An individual participant data meta-analysis.

Health-related quality of life metrics evaluate treatments in ways that matter to patients, so are often included in randomised clinical trials (hereafter trials). Multimorbidity, where individuals have 2 or more conditions, is negatively associated with quality of life. However, whether multimorbidity predicts change over time or modifies treatment effects for quality of life is unknown. Therefore, clinicians and guideline developers are uncertain about the applicability of trial findings to people with multimorbidity. We examined whether comorbidity count (higher counts indicating greater multimorbidity) (i) is associated with quality of life at baseline; (ii) predicts change in quality of life over time; and/or (iii) modifies treatment effects on quality of life. Included trials were registered on the United States trials registry for selected index medical conditions and drug classes, phase 2/3, 3 or 4, had ≥300 participants, a nonrestrictive upper age limit, and were available on 1 of 2 trial repositories on 21 November 2016 and 18 May 2018, respectively. Of 124 meeting these criteria, 56 trials (33,421 participants, 16 index conditions, and 23 drug classes) collected a generic quality of life outcome measure (35 EuroQol-5 dimension (EQ-5D), 31 36-item short form survey (SF-36) with 10 collecting both). Blinding and completeness of follow up were examined for each trial. Using trials where individual participant data (IPD) was available from 2 repositories, a comorbidity count was calculated from medical history and/or prescriptions data. Linear regressions were fitted for the association between comorbidity count and (i) quality of life at baseline; (ii) change in quality of life during trial follow up; and (iii) treatment effects on quality of life. These results were then combined in Bayesian linear models. Posterior samples were summarised via the mean, 2.5th and 97.5th percentiles as credible intervals (95% CI) and via the proportion with values less than 0 as the probability (PBayes) of a negative association. All results are in standardised units (obtained by dividing the EQ-5D/SF-36 estimates by published population standard deviations). Per additional comorbidity, adjusting for age and sex, across all index conditions and treatment comparisons, comorbidity count was associated with lower quality of life at baseline and with a decline in quality of life over time (EQ-5D -0.02 [95% CI -0.03 to -0.01], PBayes > 0.999). Associations were similar, but with wider 95% CIs crossing the null for SF-36-PCS and SF-36-MCS (-0.05 [-0.10 to 0.01], PBayes = 0.956 and -0.05 [-0.10 to 0.01], PBayes = 0.966, respectively). Importantly, there was no evidence of any interaction between comorbidity count and treatment efficacy for either EQ-5D or SF-36 (EQ-5D -0.0035 [95% CI -0.0153 to -0.0065], PBayes = 0.746; SF-36-MCS (-0.0111 [95% CI -0.0647 to 0.0416], PBayes = 0.70 and SF-36-PCS -0.0092 [95% CI -0.0758 to 0.0476], PBayes = 0.631. Treatment effects on quality of life did not differ by multimorbidity (measured via a comorbidity count) at baseline-for the medical conditions studied, types and severity of comorbidities and level of quality of life at baseline, suggesting that evidence from clinical trials is likely to be applicable to settings with (at least modestly) higher levels of comorbidity. A prespecified protocol was registered on PROSPERO (CRD42018048202).

P066 - Simultaneous Integrated Boost (SIB) Stereotactic Body Radiotherapy (SBRT) for prostate and pelvic nodes in high risk, node positive and oligometastatic prostate cancers: Safety, efficacy and quality of life outcome measures

P066 - Simultaneous Integrated Boost (SIB) Stereotactic Body Radiotherapy (SBRT) for prostate and pelvic nodes in high risk, node positive and oligometastatic prostate cancers: Safety, efficacy and quality of life outcome measures

Development and Psychometric Validation of the Olfactory Dysfunction Outcomes Rating

Olfactory dysfunction (OD) is an increasingly common and morbid condition, especially given the ongoing COVID-19 pandemic. Thus, the ability to reproducibly measure smell loss-associated quality of life (QOL) and its response to treatment is paramount. To develop and validate a concise and visually appealing smell loss-associated QOL patient-reported outcome measure for OD. A secondary analysis of comments to an online survey by 1000 patients with olfactory dysfunction published in 2013 was used as the primary source to generate items of the Olfactory Dysfunction Outcomes Rating (ODOR). In addition, 30 patients with OD enrolled in 2 clinical studies at a tertiary care medical center (Washington University) were asked to identify their main concerns associated with smell loss. And finally, 4 otolaryngologists reviewed the items generated from the online survey and the patients' interviews to identify any additional items. Prospective study design was used for data collection from the 30 patients and 4 otolaryngologists. Prospective study design was used for survey validation. Validation of the ODOR was performed with 283 patients enrolled in several prospective studies at a single institution that completed the ODOR as an outcome measure. Item generation and selection were the outcomes of ODOR development. The psychometric and clinimetric measures evaluated for validation were internal consistency, test-retest reliability, face and content validity, concurrent validity, and discriminant validity. Minimal clinically important difference was also determined. The ODOR is a 28-item instrument with each item scored as either no difficulty or very rarely bothered (0) to complete difficulty or very frequently bothered (4) with a total instrument score range of 0 to 112 points. Higher scores indicate higher degree of dysfunction and limitation. Validation in the cohort of 283 patients (mean [SD] age, 47.0 [14.4] years; 198 female participants [73%]; 179 White participants [80%]) revealed that the instrument has high internal consistency (Cronbach α = 0.968), test-retest reliability (r = 0.90 [95% CI, 0.81-0.95]), face validity, content validity, concurrent validity (r = 0.87 [95% CI, 0.80-0.91] compared with the Questionnaire of Olfactory Disorders-Negative Statements; ρ = -0.76 [95% CI, -0.81 to -0.71] compared with a patient-reported symptom severity scale), and divergent validity (mean score difference, -33.9 [95% CI, -38.3 to -29.6] between normosmic patients and hyposmic/anosmic patients). The minimal clinically important difference was 15 points. The estimated time for survey completion was approximately 5 minutes. In this survey creation and validation study, the ODOR was shown to be a novel, concise, reliable, and valid patient-reported outcome measure of OD-associated QOL. It can be used to measure physical problems, functional limitations, and emotional consequences associated with OD and how they change after a given intervention, which is clinically applicable and particularly pertinent given the growing burden of OD associated with COVID-19.