POS1055 HIGH SATISFACTION WITH USTEKINUMAB TREATMENT IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS – FINAL RESULTS OF THE NON-INTERVENTIONAL STUDY SUSTAIN DEMONSTRATE EARLY AND LONG-TERM TREATMENT RESPONSE AND HIGH TOLERABILITY

Background:From February 2015 to April 2020, patients with active psoriatic arthritis under treatment with ustekinumab in routine clinical care in Germany were included into the prospective, multi-center non-interventional study SUSTAIN.Objectives:Here, we present final data from SUSTAIN including final week 160 on long term efficacy and safety of ustekinumab treatment, quality of life and further patient reported outcomes.Methods:In SUSTAIN, 337 patients were treated with ustekinumab according to routine clinical care at 75 centers for 160 weeks with documentation intervals at week 0 and 4 and then every 12 weeks. The collected data included demographics, number of swollen and tender joints, tender entheses, amount of skin symptoms (BSA and PASI), patient reported outcome concerning disease activity and pain, Health Assessment Questionnaire (HAQ), quality of life (SF-12), sleep quality (VAS), satisfaction with therapy of patient and physician, safety (adverse events [AE]/serious adverse events [SAE]), pharmacoeconomic aspects, number of patients with „Minimal Disease Activity“ (MDA) and number of patients with MDA at week 28 und 52. For this analysis, final data of all 337 patients of all documented visits were analyzed.Results:The visit at week 4 was documented for 31 patients, at week 28 for 282, at week 52 for 216, and at week 160 for 129 of the 337 patients. At baseline, the patients had a mean age of 53.6 years (22-85) and 192 (57%) were female. The patients’ mean BMI was 29.6 kg/m2 (18.6-52). 54.3 % of the patients had at least one TNF inhibitor as prior medication. 54.1 % of the patients used MTX as concomitant medication. At time of inclusion, 73.3% of the patients showed arthritis at small and 52.2% at large joints. 16.9% showed spinal involvement and 13.1% enthesitis. In the course of the treatment, the number of tender joints improved from a mean of 10.0 (CI 95% 8.6/11.3) at baseline to 4.1 (3.2/4.9) at week 28, 3.6 (2.7/4.6) at week 52 and 1.0 (0.6/1.4) at week 160. Number of swollen joints improved from 4.1 (3.4/4.9) at baseline to 1.8 (1.2/2.3) at week 28, to 1.3 (0.8/1.8) at week 52 and to 0.4 (0.2/0.6) at week 160. BSA declined from a mean of 15.6% (rage from 0 to 80.0%) at baseline to 5.2% (0 to 60%) at week 28, to 3.0% (0 to 45.0%) at week 52 and to 1.7 (0 to 35%) at week 160. PASI declined from a mean of 7.3 (range from 0 to 43.0) at baseline to 1.7 (0 to 24.8) at week 28, to 1.3 (o to 28.5) at week 52 and to 0.5 (0 to 3.2) at week 160. Efficacy of the therapy with ustekinumab was assessed as “very good” or “good” by 85.3% of the treating physicians at week 52 and by 94.1% at week 160. The patients assessed the efficacy as “very good” or “good” by 82.8% at week 52 and by 89.8% at week 160. At the end of the study, 96 SAEs have been documented, of which only 16 were related to ustekinumab. All in all, safety of therapy with ustekinumab was assessed as “very good” or “good” by 99% of the treating physicians after 52 weeks and by 99.2 % after 160 weeks. The patients assessed the safety as “very good” or “good” by 97.5% at week 52 and by 100% at week 160.Conclusion:The non-interventional study SUSTAIN showed relevant disease improvements and good safety with an outstanding high therapy satisfaction in patients with active psoriatic arthritis treated with ustekinumab. Treatment effect was observed as early as after 4 weeks. The treatment effects and satisfaction sustained up end of documentation at week 160 in daily practice life.Disclosure of Interests:None declared.

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Real-world use of epic for clinical practice (EPIC-CP) to assess patient-reported prostate cancer quality of life in the clinical setting.

Journal of Clinical Oncology ◽

10.1200/jco.2015.33.7_suppl.18 ◽

2015 ◽

Vol 33 (7_suppl) ◽

pp. 18-18 ◽

Cited By ~ 1

Author(s):

Peter Chang ◽

Arie Carneiro ◽

Ostap Dovirak ◽

Kimberly Taylor ◽

Catrina Crociani ◽

...

Keyword(s):

Quality Of Life ◽

Prostate Cancer ◽

Clinical Practice ◽

Clinical Care ◽

Post Treatment ◽

Rank Test ◽

Routine Clinical Care ◽

Patient Reported ◽

Domain Scores

18 Background: Prostate cancer practitioners tend to underestimate patients’ treatment-related side effects. We developed the Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) to facilitate patient-reported health-related quality of life (HRQOL) assessment at the point-of-care (Chang P et al, J Urol Sep 2011). We sought to demonstrate the feasibility of EPIC-CP use in routine clinical care, and to compare longitudinal patient-reported and practitioner-reported prostate cancer outcomes. Methods: We reviewed practitioner- and patient-reported HRQOL outcomes in 482 patients who underwent radical prostatectomy at our institution from 2010 to 2014. All EPIC-CP questionnaires were administered and interpreted without research personnel. Practitioner-reported outcomes were assessed using chart review. We used the paired t-test and Wilcoxon signed-rank test to compare pre- and post-treatment EPIC-CP domain scores, and Fisher’s exact test to compare patient-reported and practitioner-reported outcomes. We considered p-values < 0.05 statistically significant. Results: 708 total EPIC-CP questionnaires were completed. Mean urinary incontinence domain scores increased (worsened) significantly from baseline (0.6±0.2) to 3 (3.1±2.3) and 6 months (2.2±2.1) post-treatment, but were not statistically changed from baseline at 12 months (1.6±1.7). Patient-reported incontinence pad-free rates using EPIC-CP at 3, 6, and 12 months were 47%, 76%, and 78%, respectively, which were consistent with practitioner-reported rates. Mean sexual domain scores were significantly worse at 12 months (5.9±3.3) compared to baseline (2.4±2.8). Practitioners significantly overestimated the rate of functional erections compared to patients’ EPIC-CP-reported rates at 3 months (18% vs 12%, p < 0.05) and 12 months (45% vs 23%, p < 0.05). Bowel and vitality/hormonal scores were unchanged, and urinary irritation/obstruction scores improved after surgery. Conclusions: EPIC-CP is feasible to use in the routine clinical care of prostate cancer patients, and can help practitioners more accurately assess patients’ post-treatment symptom severity.

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P14.20 Quality of life of patients with newly diagnosed glioblastoma during TTFields therapy in routine clinical care: first results of the TIGER study

Neuro-Oncology ◽

10.1093/neuonc/noab180.143 ◽

2021 ◽

Vol 23 (Supplement_2) ◽

pp. ii41-ii42

Author(s):

O Bähr ◽

G Tabatabai ◽

R Fietkau ◽

R Goldbrunner ◽

M Glas

Keyword(s):

Quality Of Life ◽

Clinical Care ◽

Treatment Compliance ◽

Phase Iii ◽

Interdisciplinary Treatment ◽

Interventional Study ◽

Routine Clinical Care ◽

Health Related

Abstract BACKGROUND Glioblastoma (GBM) is an aggressive primary tumor of the central nervous system. Current interdisciplinary treatment strategies outside clinical trials include maximal safe resection, followed by treatment with radiation and an alkylating chemotherapy. Based on the results of the positive phase III trial EF-14, the addition of Tumor Treating Fields (TTFields) to temozolomide (TMZ) maintenance therapy brought an additional treatment method to clinical routine. The prospective non-interventional study TIGER (TTFields In GErmany in Routine Clinical Care) documents the use of TTFields in routine clinical care with a particular focus on health-related quality of life (HRQoL) within 4 months after starting therapy, treatment compliance and duration. MATERIAL AND METHODS This multi-center prospective non-interventional study in Germany (NCT03258021) included ndGBM patients eligible for TTFields therapy. Following their consent to participate in the study, patients received a comprehensive introduction to the therapy and their baseline demographic data were collected. Information on TTFields therapy decision is evaluated based on a dedicated TTFields questionnaire at baseline in both arms, follow-up information on how patients cope with the therapy is collected two months after TTFields treatment start, if applicable. HRQoL was assessed in patients deciding for TTFields therapy at baseline as well as at 2 months and 4 months thereafter using the EORTC-QLQ-C30/BN-20 questionnaires. RESULTS Between August 2017 and November 2019, 710 patients (259 female/451 male) were enrolled at 81 participating centers. The mean age was 58.5 years (range: 19.0–85.0; Cut-off: August 31, 2020). The overall baseline characteristics of the study group reflects a typical GBM population. Of these, 582 (82%) decided to start TTFields and 128 (18%) refused TTFields treatment. Health-related QoL did not decline during TTFields therapy except for itchy skin, comparable to the results of the EF-14 phase 3 trial. A detailed analysis of the cohort as well as their reported QoL will be presented. CONCLUSION The TIGER study is the largest non-interventional trial on the use of TTFields in routine clinical care. The use of TTFields in patients with ndGBM did not impair HRQoL during the follow-up period, except for more itchy skin.

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Does the Patient-Reported Apnea Questionnaire (PRAQ) increase patient-centredness in the daily practice of sleep centres? a mixed-methods study

BMJ Open ◽

10.1136/bmjopen-2018-025963 ◽

2019 ◽

Vol 9 (6) ◽

pp. e025963

Author(s):

Inger L Abma ◽

Maroeska M Rovers ◽

Marijke IJff ◽

Bernard Hol ◽

Masha Nägele ◽

...

Keyword(s):

Quality Of Life ◽

Clinical Practice ◽

Mixed Methods ◽

Clinical Care ◽

Healthcare Providers ◽

Obstructive Sleep ◽

Number Of Patients ◽

Patient Reported ◽

Patient Centredness

ObjectivesThe objective of this exploratory study was to see how the Patient-Reported Apnea Questionnaire (PRAQ) may impact the daily clinical practice of sleep centres, and why it may or may not work as expected. The hypotheses were tested that this patient-reported outcome measure makes patients more aware of which of their health complaints may be related to obstructive sleep apnoea (OSA), and that it improves patient-centredness of care by shifting the focus of care away from (only) medical problems towards the individual burden of disease and quality of life.DesignMixed methods. The quantitative study (surveys, patient records) was a before-and-after study.SettingThree sleep centres in The Netherlands (secondary care).Participants27 patients and 14 healthcare professionals were interviewed. 487 patients completed surveys pre-implementation, and 377 patients completed surveys post-implementation of the PRAQ. For the health records, 125 patients were included in the pre-implementation group, and 124 other patients in the post-implementation group.InterventionsThe PRAQ was used in clinical practice for six successive months.Outcome measuresScores on individual survey items, number of patients receiving non-medical treatment, adjustment of treatment at first follow-up, compliance with treatment.ResultsPatients were generally positive about the usefulness of the PRAQ before and during the consultation, as they felt more informed. Healthcare providers did not consider the PRAQ very useful, and they reported minor impact on their consultations. The surveys and health record study did not show an impact of the PRAQ on clinical practice.ConclusionsImplementing the PRAQ may be beneficial to patients, but this study does not show much impact with regard to patient-centredness of care. New Dutch guidelines for OSA care may lead to a greater emphasis on quality of life and value of care for patients, making its integration in clinical care potentially more useful.

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Quality of Life for Children with Persistent Sinonasal Symptoms

Otolaryngology ◽

10.1067/mhn.2003.41 ◽

2003 ◽

Vol 128 (1) ◽

pp. 17-26 ◽

Cited By ~ 97

Author(s):

David J. Kay ◽

Richard M. Rosenfeld

Keyword(s):

Quality Of Life ◽

Clinical Care ◽

Longitudinal Change ◽

Good Test ◽

Routine Clinical Care ◽

Before And After ◽

The Mean ◽

The Individual ◽

Sinonasal Symptoms

OBJECTIVE: The goal was to validate the SN-5 survey as a measure of longitudinal change in health-related quality of life (HRQoL) for children with persistent sinonasal symptoms. DESIGN AND SETTING: We conducted a before and after study of 85 children aged 2 to 12 years in a metropolitan pediatric otolaryngology practice. Caregivers completed the SN-5 survey at entry and at least 4 weeks later. The survey included 5 symptom-cluster items covering the domains of sinus infection, nasal obstruction, allergy symptoms, emotional distress, and activity limitations. RESULTS: Good test-retest reliability ( R = 0.70) was obtained for the overall SN-5 score and the individual survey items ( R ≥ 0.58). The mean baseline SN-5 score was 3.8 (SD, 1.0) of a maximum of 7.0, with higher scores indicating poorer HRQoL. All SN-5 items had adequate correlation ( R ≥ 0.36) with external constructs. The mean change in SN-5 score after routine clinical care was 0.88 (SD, 1.19) with an effect size of 0.74 indicating good responsiveness to longitudinal change. The change scores correlated appropriately with changes in related external constructs ( R ≥ 0.42). CONCLUSIONS: The SN-5 is a valid, reliable, and responsive measure of HRQoL for children with persistent sinonasal symptoms, suitable for use in outcomes studies and routine clinical care.

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Prospective observational study to examine health-related quality of life and develop models to predict long-term patient-reported outcomes 6 months after hospital discharge with blunt thoracic injuries

BMJ Open ◽

10.1136/bmjopen-2021-049292 ◽

2021 ◽

Vol 11 (7) ◽

pp. e049292

Author(s):

Edward Baker ◽

Ceri Battle ◽

Abhishek Banjeri ◽

Edward Carlton ◽

Christine Dixon ◽

...

Keyword(s):

Quality Of Life ◽

Hospital Discharge ◽

Brief Pain Inventory ◽

Thoracic Injuries ◽

Patient Reported ◽

Related Quality ◽

Paindetect Questionnaire ◽

Health Related

ObjectiveThis study aimed to examine the long-term outcomes and health-related quality of life in patients with blunt thoracic injuries over 6 months from hospital discharge and develop models to predict long-term patient-reported outcomes.DesignA prospective observational study using longitudinal survey design.SettingThe study recruitment was undertaken at 12 UK hospitals which represented diverse geographical locations and covered urban, suburban and rural areas across England and Wales.Participants337 patients admitted to hospital with blunt thoracic injuries were recruited between June 2018–October 2020.MethodsParticipants completed a bank of two quality of life surveys (Short Form-12 (SF-12) and EuroQol 5-Dimensions 5-Levels) and two pain questionnaires (Brief Pain Inventory and painDETECT Questionnaire) at four time points over the first 6 months after discharge from hospital. A total of 211 (63%) participants completed the outcomes data at 6 months after hospital discharge.Outcomes measuresThree outcomes were measured using pre-existing and validated patient-reported outcome measures. Outcomes included: Poor physical function (SF-12 Physical Component Score); chronic pain (Brief Pain Inventory Pain Severity Score); and neuropathic pain (painDETECT Questionnaire).ResultsDespite a trend towards improving physical functional and pain at 6 months, outcomes did not return to participants perceived baseline level of function. At 6 months after hospital discharge, 37% (n=77) of participants reported poor physical function; 36.5% (n=77) reported a chronic pain state; and 22% (n=47) reported pain with a neuropathic component. Predictive models were developed for each outcome highlighting important data collection requirements for predicting long-term outcomes in this population. Model diagnostics including calibration and discrimination statistics suggested good model fit in this development cohort.ConclusionsThis study identified the recovery trajectories for patients with blunt thoracic injuries over the first 6 months after hospital discharge and present prognostic models for three important outcomes which after external validation could be used as clinical risk stratification scores.

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A study of patients’ quality of life more than 5 years after trauma: a prospective follow-up

Health and Quality of Life Outcomes ◽

10.1186/s12955-020-01652-1 ◽

2021 ◽

Vol 19 (1) ◽

Author(s):

Fanny Vardon-Bounes ◽

Romain Gracia ◽

Timothée Abaziou ◽

Laure Crognier ◽

Thierry Seguin ◽

...

Keyword(s):

Quality Of Life ◽

Economic Impact ◽

Physical Functioning ◽

Major Trauma ◽

Injury Severity ◽

Number Of Patients ◽

Sf 36 ◽

Socio Economic Impact

Abstract Background The long-term fate of severely injured patients in terms of their quality of life is not well known. Our aim was to assess the quality of life of patients who have suffered moderate to severe trauma and to identify primary factors of long-term quality of life impairment. Methods A prospective monocentric study conducted on a number of patients who were victims of moderate to severe injuries during the year 2012. Patients were selected based on an Injury Severity Score (ISS) more than or equal to 9. Quality of life was assessed by the MOS SF-36 and NHP scores as a primary evaluation criterion. The secondary evaluation criteria were the determination of the socio-economic impact on quality of life and the identification of factors associated with disability. Results Two hundred and eight patients were contacted by e-mail or telephone. Fifty-five patients participated in this study (with a participation level of 26.4%), including 78.2% men, with a median age of 46. Significant alterations in quality of life were observed with the NHP and MOS SF-36 scale, including physical and psychological components. This resulted in a major socio-economic impact as 26% of the patients could not resume their professional activities (n = 10), 20% required retraining in other lines of work, and 36.4% had a disability status. The study showed that scores ≤ 85 on the physical functioning variable of the MOS SF 36 scale was associated with disability. Conclusion More than five years after a moderate to severe injury, patients’ quality of life was significantly impacted, resulting in significant socio-economic consequences. Disability secondary to major trauma seems to be associated with a score ≤ 85 on the physical functioning dimension of the MOS SF-36 scale. This study raises the question of whether or not early rehabilitation programs should be implemented in order to limit the long-term impact of major trauma.

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Determinants of Cancer-specific Quality of Life in Veteran Lung Cancer Survivors Eligible for Long-Term Cure

10.1101/518910 ◽

2019 ◽

Author(s):

Duc Ha ◽

Andrew L. Ries ◽

Jeffrey J. Swigris

Keyword(s):

Quality Of Life ◽

Lung Cancer ◽

Cancer Survivors ◽

Summary Score ◽

European Organization ◽

Specific Patient ◽

Patient Reported ◽

Sleep Difficulties

AbstractRationale/ObjectiveQuality of life (QoL) is an important issue in lung cancer survivors. We aimed to identify determinants of QoL in lung cancer survivors eligible for long-term cure.MethodsWe performed an exploratory analysis of a cross-sectional study of consecutive lung cancer survivors who completed curative-intent treatment ≥1 month previously. Variables tested included demographic, clinical, physiologic, and symptom-specific patient-reported outcome measures. We defined the primary outcome as a previously-validated cancer-specific QoL measure – the European Organization for Research and Treatment of Cancer QoL Questionnaire Core 30 (C30) summary score. We also verified our findings with the C30 global health status/QoL subscale and a summated score of lung cancer-specific QoL from the EORTC-Lung Cancer Module 13.ResultsIn 75 enrolled participants, measures of fatigue, depression, sleep difficulties, and dyspnea were statistically significant determinants of the C30 summary score in multivariable linear regression analyses. Together, these four symptoms accounted for approximately 85% of the variance in cancer-specific QoL (p<0.001). When we verified our findings with global QoL and lung cancer-specific QoL, fatigue and dyspnea were consistent determinants of QoL.ConclusionsWe found four symptoms – dyspnea, fatigue, depression, and sleep difficulties – that are important determinants of and together accounted for almost all of the variance in cancer-specific QoL in lung cancer survivors eligible for long-term cure. These findings have implications to reduce symptom burden and improve function and QoL in these patients.

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Achieving and maintaining long-term optimal improvements in patient-reported symptoms, signs, and quality of life among patients with moderate to severe psoriasis treated with guselkumab: 3-year data from VOYAGE 1

Journal of the American Academy of Dermatology ◽

10.1016/j.jaad.2019.06.616 ◽

2019 ◽

Vol 81 (4) ◽

pp. AB165

Keyword(s):

Quality Of Life ◽

Severe Psoriasis ◽

Patient Reported

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275 POSTOPERATIVE COMPLICATIONS DO NOT AFFECT QUALITY OF LIFE AFTER ESOPHAGECTOMY

Diseases of the Esophagus ◽

10.1093/dote/doaa087.59 ◽

2020 ◽

Vol 33 (Supplement_1) ◽

Author(s):

E Jezerskyte ◽

H Laarhoven ◽

M Sprangers ◽

W Eshuis ◽

M Hulshof ◽

...

Keyword(s):

Quality Of Life ◽

Postoperative Complications ◽

Term Survival ◽

Radio Therapy ◽

Significant Difference ◽

Patient Reported ◽

Short And Long Term ◽

Over Time

Abstract Despite the attempts to reduce postoperative complication incidence after esophageal cancer surgery, up to 60% of patients endure postoperative complications. These patients often have a reduced health related quality of life (HR-QoL) and it may also have a negative effect on long-term survival. The aim of this study is to investigate the difference in short- and long-term HR-QoL in patients with and without a complicated postoperative course. Methods A retrospective comparative cohort study was performed with data from the Dutch Cancer Registry (IKNL) and QoL questionnaires from POCOP, a longitudinal patient reported outcomes study. All patients with esophageal and gastroesophageal junction (GEJ) cancer after an esophagectomy with or without neoadjuvant chemo(radio) therapy in the period of 2015–2018 were included. Exclusion criteria were palliative surgery, patients with a recurrence, reconstruction with a colonic or jejunal interposition, no reconstruction and emergency surgery. HR-QoL was investigated at baseline and at 3, 6, 9, 12, 18 and 24 months postoperatively between patients with and without complications following an esophagectomy. Results A total of 486 patients were included: 270 with and 216 without postoperative complications. The majority of patients were male (79.8%) with a median age of 66 years (IQR 60–70.25). Significantly more patients had comorbidities in the group with postoperative complications (69.6% vs 57.3%, p = 0.001). A significant difference in HR-QoL over time was found between the two groups in “choked when swallowing” score (p = 0.028). Patients that endured postoperative complications reported more problems with choking when swallowing at 9 months follow-up (mean score 12.9 vs 8.4, p = 0.047). This difference was not clinically relevant with a mean score difference of 4.6 points. Conclusion Postoperative complications do not significantly influence the short- and long-term HR-QoL in patients following an esophagectomy. Only one HR-QoL domain showed difference over time, however, this was not clinically relevant.

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