Patient-reported outcomes (PROs) with ibrutinib-rituximab in Waldenström macroglobulinemia (WM): Results from iNNOVATE.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 8018-8018
Author(s):  
Alessandra Tedeschi ◽  
Meletios A. Dimopoulos ◽  
Judith Trotman ◽  
Ramón Garcia-Sanz ◽  
David MacDonald ◽  
...  
Keyword(s):  
Pearson Correlation ◽  
Single Agent ◽  
Correlation Coefficients ◽  
Subscale Score ◽  
Trade Mark ◽  
Meaningful Improvement ◽  
Patient Reported ◽  
Clinical Trial Information

8018 Background: Anemia and fatigue can impair quality of life in patients (pts) with WM. Ibrutinib (ibr) as single agent or in combination with RTX is FDA-approved for WM. In pts with RTX-refractory WM, single-agent ibr induced meaningful improvements in PROs (Trotman, EHA 2017). In iNNOVATE, ibr-RTX (IR) produced higher rates of sustained hemoglobin improvement and meaningful improvements in PROs versus placebo-RTX (R; Dimopoulos NEJM 2018). Here, we report detailed PRO analyses from iNNOVATE. Methods: Pts with symptomatic WM requiring therapy were randomized to daily 420 mg oral ibr or placebo, both with RTX (375 mg/m2/week IV at weeks 1–4 and 17–20). PRO measures included FACIT-Fatigue (FACIT-F), FACT-An total score (TS) and anemia subscale score (AS), and EQ-5D-5L (EuroQol Research Foundation. EQ-5D is a trade mark of the EuroQol Research Foundation) visual analog scale (VAS), and utility score (US). Results: For 150 randomized pts (n=75/arm), most common reasons for initiating therapy were fatigue (61%), constitutional symptoms (32%), and anemia (32%). Baseline PRO scores were comparable in both arms. At a median follow-up of 26.5 mo, numerically more pts showed clinically meaningful improvement in FACIT-F, TS, and AS with IR than R (Table). Median time to PRO improvement was short (1-2 mo) in both arms. At week 25, the Pearson correlation coefficients were 0.28, 0.29, and 0.26 for changes in hemoglobin levels vs changes in FACIT-F, TS and AS, respectively, in the IR arm; no meaningful correlations were observed on R. The correlation coefficients were -0.32, -0.33, -0.35 and -0.26 for changes in IgM levels vs changes in FACIT-F, TS, AS, and EQ-VAS, respectively, for IR and 0.29 and 0.35 vs FACIT-F and TS for R. Conclusions: Clinical response and improvements in anemia with IR are consistent with more pts showing clinically meaningful improvement in PROs versus R. Changes in IgM correlate with improvements in PROs. Clinical trial information: NCT02165397. [Table: see text]

scholarly journals 3527 Quantifying the psychosocial benefits of masculinizing chest reconstruction in transgender men with patient reported outcomes: The GENDER-Q

2019 ◽  
Vol 3 (s1) ◽  
pp. 125-125
Author(s):  
Adrienne Kennedy ◽  
Andre Alcon ◽  
Esther Kim
Keyword(s):  
Quality Of Life ◽  
Psychological Health ◽  
Online Survey ◽  
Assessment Tool ◽  
Medical Center ◽  
Pearson Correlation ◽  
Patient Reported ◽  
One Year

OBJECTIVES/SPECIFIC AIMS: 1. To evaluate the effects of masculinizing chest reconstruction on the quality of life of female-to-male transgender individuals. 2. To develop and validate a quality of life survey for female-to-male transgender individuals undergoing masculinizing chest reconstruction gender-affirming surgery. METHODS/STUDY POPULATION:. We developed and refined the GENDER-Q using focus groups and exploratory interviews with FTM individuals that were recorded, transcribed, and coded. All consenting FTM patients undergoing chest reconstruction at UCSF Parnassus Medical center between 2017-2019 who meet World Professional Association for Transgender Health (WPATH) criteria for gender dysphoria will be enrolled in the study. The GENDER-Q will be co-administered with the WHO Quality of Life-BREF survey pre-operatively, 6 weeks post-operatively, and one year post-operatively through REDCAP, an online survey database. RESULTS/ANTICIPATED RESULTS: Approximately 70 patients will be enrolled in the study. Preliminary results detect statistically significant mean quality of life post-operative improvements in all three sections (Physical Health, Gender Presentation, Psychological Health) of the GENDER-Q at 6-week follow up that is maintained at one-year (p< 0.005). Statistically significant improvements were similarly achieved and maintained with the WHO QOL-BREF survey (p< 0.05). The mean reported improvement from baseline to follow-up appears to be more pronounced in the GENDER-Q survey compared to WHO QOL-BREF. The median time to complete the pre and post-operative surveys was 10 minutes. Calculation of Cronbach’s (0.67-0.81) and the Pearson Correlation Coefficient for each section revealed excellent internal validity. DISCUSSION/SIGNIFICANCE OF IMPACT: There are few studies assessing quality of life outcomes in transgender patients undergoing gender-affirming surgeries. A standardized and validated assessment tool will provide the means for which data can be pooled in large multi-center studies. Providing further evidence to support the positive health outcomes of gender-affirming surgeries can lead to broader access and reduce healthcare disparities among transgender populations.

The effect of surgery in tenosynovial giant cell tumours as measured by patient-reported outcomes on quality of life and joint function

2019 ◽  
Vol 101-B (3) ◽  
pp. 272-280 ◽  
Author(s):  
F. G. M. Verspoor ◽  
M. J. L. Mastboom ◽  
G. Hannink ◽  
W. T. A. van der Graaf ◽  
M. A. J. van de Sande ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Giant Cell ◽  
Diffuse Type ◽  
Joint Function ◽  
Population Means ◽  
Sf 36 ◽  
Patient Reported ◽  
The Impact

Aims The aim of this study was to evaluate health-related quality of life (HRQoL) and joint function in tenosynovial giant cell tumour (TGCT) patients before and after surgical treatment. Patients and Methods This prospective cohort study run in two Dutch referral centres assessed patient-reported outcome measures (PROMs; 36-Item Short-Form Health Survey (SF-36), visual analogue scale (VAS) for pain, and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)) in 359 consecutive patients with localized- and diffuse-type TGCT of large joints. Patients with recurrent disease (n = 121) and a wait-and-see policy (n = 32) were excluded. Collected data were analyzed at specified time intervals preoperatively (baseline) and/or postoperatively up to five years. Results A total of 206 TGCT patients, 108 localized- and 98 diffuse-type, were analyzed. Median age at diagnosis of localized- and diffuse-type was 41 years (interquartile range (IQR) 29 to 49) and 37 years (IQR 27 to 47), respectively. SF-36 analyses showed statistically significant and clinically relevant deteriorated preoperative and immediate postoperative scores compared with general Dutch population means, depending on subscale and TGCT subtype. After three to six months of follow-up, these scores improved to general population means and continued to be fairly stable over the following years. VAS scores, for both subtypes, showed no statistically significant or clinically relevant differences pre- or postoperatively. In diffuse-type patients, the improvement in median WOMAC score was statistically significant and clinically relevant preoperatively versus six to 24 months postoperatively, and remained up to five years’ follow-up. Conclusion Patients with TGCT report a better HRQoL and joint function after surgery. Pain scores, which vary hugely between patients and in patients over time, did not improve. A disease-specific PROM would help to decipher the impact of TGCT on patients’ daily life and functioning in more detail. Cite this article: Bone Joint J 2019;101-B:272–280.

scholarly journals Outcomes of the rotating hinge knee in revision total knee arthroplasty with a median follow-up of 6.2 years

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Jake von Hintze ◽  
Mika Niemeläinen ◽  
Harri Sintonen ◽  
Jyrki Nieminen ◽  
Antti Eskelinen
Keyword(s):  
Quality Of Life ◽  
Total Knee Arthroplasty ◽  
Survival Rate ◽  
Knee Arthroplasty ◽  
Revision Total Knee Arthroplasty ◽  
Patient Reported ◽  
Total Knee ◽  
Revision Tka

Abstract Background The purpose of this study was to determine the mid-term clinical, radiographic and health-related quality of life (HRQoL) outcomes and define the survival rate in patients who had undergone revision total knee arthroplasty (TKA) using the single rotating hinged knee (RHK) design. Methods Between January 2004 and December 2013, 125 revision TKAs were performed at our institution using the single RHK implant. We conducted both a retrospective analysis of prospectively collected outcome data of these patients and a prospective follow-up study of all 39 living patients (41 knees). The follow-up phase included an optional extra follow-up visit, PROM questionnaires, and plain radiographs. Results The ten-year Kaplan-Meier survival rate of the revision RHK knees was 81.7% (95% CI 71.9–91.6%) with re-revision for any reason as the endpoint. Overall, 15 knees (12% of the total) underwent re-revision surgery during the follow-up. The median follow-up was 6.2 years (range, 0–12.7 years) post-operatively for the baseline group. One mechanical hinge mechanism-related failure occurred without any history of trauma or infection. At the time of the final follow-up, the majority of patients evinced a fairly good clinical outcome measured with patient-reported outcome measures and none of the components were radiographically loose. Conclusion We found that in patients undergoing complex revision TKA, fairly good functional outcome and quality of life can be achieved using an RHK implant. Further, it seems that in this type of patient cohort, revision TKA using an RHK implant relieves pain more than it improves ability to function. The NexGen® RHK design can be regarded as a suitable option in complex revision TKA.

scholarly journals POS1418 REALIZING EARLY RECOGNITION OF ARTHRITIS IN TIMES OF INCREASED TELEMEDICINE: THE VALUE OF PATIENT-REPORTED SWOLLEN JOINTS

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 992.1-992
Author(s):  
C. Rogier ◽  
B. Van Dijk ◽  
E. Brouwer ◽  
P. De Jong ◽  
A. Van der Helm - van Mil
Keyword(s):  
Early Recognition ◽  
Pearson Correlation ◽  
Correlation Coefficients ◽  
Self Report ◽  
Symptom Duration ◽  
Likelihood Ratios ◽  
Predictive Values ◽  
Patient Level ◽  
Patient Reported ◽  
Joint Examination

Background:Early diagnosis and management of patients with inflammatory arthritis(IA) are critical to improve long-term patient-outcomes. Assessment of joint swelling at joint examination is the reference of IA-identification; early access clinics are constructed to promote this early recognition of IA. However, due to the COVID-19 pandemic the face-to-face capacity of such services is severely reduced. The accuracy of patient-reported swelling in comparison to joint examination has been extensively evaluated in established RA (ρ 0.31-0.67), but not in patients suspected for IA.[1]Objectives:To promote evidence based care in the era of telemedicine, we determined the accuracy of patient-reported joint swelling for actual presence of IA in persons suspected of IA by general practitioners(GP).Methods:Data from two Dutch Early Arthritis Recognition Clinics were studied. These are screening clinics (1.5-lines-setting) where GPs send patients in case of doubt on IA. At this clinic patients were asked to mark the presence of swollen joints on a mannequin with 52 joints. For this study the DIP joints and the metatarsal joints were excluded and, therefore, a total of 42 joints were assessed for self-reported joint swelling. Clinically apparent IA of ≥1 joint determined by the physician was the reference to calculate sensitivity, specificity, positive and negative likelihood ratios (LR+,LR-), and positive and negative predictive values (PPV, NPV) on patient-level. Pearson correlation coefficients(ρ) were determined. Predictive values depend on the prevalence of a disease in a population. Because the prevalence of IA in a 1.5-lines-setting will differ from a primary care setting, post-test probabilities of IA were estimated for two lower prior-test probabilities as example, namely 20% (estimated probability in patients GPs belief IA is likely) and 2% (prior-test probability with less preselection by GPs), using likelihood ratios and nomograms.Results:A total of 1637 consecutive patients were studied. Median symptom duration was 13 weeks. 76% of patients marked ≥1swollen joint at the mannequin. 41% of patients had ≥1swollen joint at examination by rheumatologists. ρ was 0.20(patient-level)-0.26(joint-level).The sensitivity of patients-reported joint swelling was high, 87%, indicating that the majority of patients with IA had marked swelling on the mannequin. However the specificity was 31%, indicating that 69% of persons without IA had also done so. The LR+ was 1.25; the LR- 0.43. The PPV was 46%, the NPV 77%. Thus the PPV increased hardly (from 41% to 46%) and the NPV somewhat (from 59% to 77%). Also in settings with prior-test probabilities of 20% and 2%, estimated PPVs (from respectively 20% and 2% to 24% and 2%) and NPVs (from respectively 80% and 98% to 90% and 99%) hardly increased.Conclusion:Patient-reported joint swelling had little value in distinguishing patients with/without IA for different prior-test probabilities, and is less valuable in comparison to self-reported flare detection in established RA.References:[1]Barton JL, Criswell LA, Kaiser R, et al. Systematic review and metaanalysis of patient self-report versus trained assessor joint counts in rheumatoid arthritis. J Rheumatol 2009;36:2635-2641.Disclosure of Interests:None declared

Significance of patient-reported outcomes for occupational resumption and quality of life after cardiac rehabilitation

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A Salzwedel ◽  
I Koran ◽  
E Langheim ◽  
A Schlitt ◽  
J Nothroff ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Performance ◽  
Well Being ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Funding Source ◽  
Patient Reported ◽  
Returning To Work

Abstract Introduction Comprehensive cardiac rehabilitation (CR) programs based on the bio-psycho-social approach of the international classification of functioning and disease are carried out to achieve improved prognosis, superior health-related quality of life (HRQL) and social integration. We aimed to identify predictors of returning to work (RTW) and HRQL among cardiovascular risk factors and physical performance as well as patient-reported outcome measures (PROMs) modifiable during CR. Methods We designed a prospective observational multi-center study and enrolled 1,586 patients (2017/18) in 12 German rehabilitation centers regardless of their primary allocation diagnoses (e.g. acute myocardial infarction (AMI), coronary artery bypass grafting (CABG), coronary artery disease (CAD), valvular disease). Besides general data (e.g. age, gender, diagnoses), parameters of risk factor management (e.g. smoking, lipid profile, hypertension, lifestyle change motivation), physical performance (e.g. maximum exercise capacity, endurance training load, 6-min walking distance), and PROMs (e.g. depression, heart-focused anxiety, HRQL, subjective well-being, somatic and mental health, pain, general self-efficacy, pension desire as well as self-assessment of occupational prognosis using several questionnaires) were documented at CR admission and discharge. 6 months after discharge, status of RTW and HRQL (SF-12) were captured by a follow-up (FU) survey and analyzed in multivariable regression models with multiple imputation of missing values. Results Out of the study participants, 1,262 patients (54±7 years, 77% men) responded to the follow-up survey and could be analyzed regarding the outcome parameters. Most of them were assigned to CR primarily due to AMI (40%) or CAD without myocardial infarction (18%), followed by heart valve diseases in 12% of patients and CABG (8%). 864 patients (69%) returned to work within the follow-up period. Pension desire, negative self-assessed occupational prognosis, heart-focussed anxiety, major life events, smoking and heart failure were negatively associated with RTW, while higher endurance training load, HRQL and work stress were positively associated (Figure 1). HRQL after 6 months was determined more by PROMs (e.g. pension desire, heart-focused anxiety, physical/mental HRQL in SF-12, physical/mental health in indicators of rehab-status questionnaire (IRES-24), stress, well-being in the World Health Organization well-being index and self-efficacy expectations) than by clinical parameters or physical performance. Conclusions Patient-reported outcome measures predominantly influenced RTW and HRQL in heart-disease patients, whereas patients' pension desire and heart-focussed anxiety had a dominant impact on all investigated endpoints. Therefore, the multi-component CR approach focussing on psychosocial support is crucial for subjective health prognosis and occupational resumption. Figure 1. Predictors of returning to work Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): German pension insurance

scholarly journals Patient-proxy agreement on change in acute stroke patient-reported outcome measures: a prospective study

2021 ◽  
Vol 5 (1) ◽  
Author(s):  
Brittany R. Lapin ◽  
Nicolas R. Thompson ◽  
Andrew Schuster ◽  
Irene L. Katzan
Keyword(s):  
Physical Function ◽  
Inpatient Rehabilitation ◽  
Patient Reported Outcome Measures ◽  
Meaningful Change ◽  
Meaningful Improvement ◽  
T Score ◽  
Patient Reported ◽  
Exact Agreement ◽  
Over Time

Abstract Objectives Research has indicated proxies overestimate symptoms on patients’ behalves, however it is unclear whether patients and proxies agree on meaningful change across domains over time. The objective of this study is to assess patient-proxy agreement over time, as well as agreement on identification of meaningful change, across 10 health domains in patients who underwent acute rehabilitation following stroke. Methods Stroke patients were recruited from an ambulatory clinic or inpatient rehabilitation unit, and were included in the study if they were undergoing rehabilitation. At baseline and again after 30 days, patients and their proxies completed PROMIS Global Health and eight domain-specific PROMIS short forms. Reliability of patient-proxy assessments at baseline, follow-up, and the change in T-score was evaluated for each domain using intra-class correlation coefficients (ICC(2,1)). Agreement on meaningful improvement or worsening, defined as 5+ T-score points, was compared using percent exact agreement. Results Forty-one patient-proxy dyads were included in the study. Proxies generally reported worse symptoms and functioning compared to patients at both baseline and follow-up, and reported less change than patients. ICCs for baseline and change were primarily poor to moderate (range: 0.06 (for depression change) to 0.67 (for physical function baseline)), and were better at follow-up (range: 0.42 (for anxiety) to 0.84 (for physical function)). Percent exact agreement between indicating meaningful improvement versus no improvement ranged from 58.5–75.6%. Only a small proportion indicated meaningful worsening. Conclusions Patient-proxy agreement across 10 domains of health was better following completion of rehabilitation compared to baseline or change. Overall change was minimal but the majority of patient-proxy dyads agreed on meaningful change. Our study provides important insight for clinicians and researchers when interpreting change scores over time for questionnaires completed by both patients and proxies.

scholarly journals Factors related to perceived continuity of care in hospitalized cardiac patients

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
E Safstrom ◽  
T.J Jaarsma ◽  
L.N Nordgren ◽  
M.L Liljeroos ◽  
A.S Stomberg
Keyword(s):  
Quality Of Life ◽  
Primary Care ◽  
Health Care ◽  
Continuity Of Care ◽  
Perceived Control ◽  
Care Utilization ◽  
Funding Source ◽  
Patient Reported

Abstract Background Since healthcare systems are increasingly complex and often fragmented, continuity of care after hospitalization is a priority to increase patient safety and satisfaction. Aim Describe factors related to continuity of care in patients hospitalized due to cardiac conditions. Methods This cross-sectional multicenter study enrolled patients 6 weeks after hospitalization due to cardiac conditions. A total of 993 patients were included (mean age 72.2 (SD 10.4), males 66%) with AMI (35%), AF (25%), angina (21%) and HF (17.3%). Patients completed the Patient Continuity of Care Questionnaire, a questionnaire based on the definition that continuity of care is “the extent to which a series of health care services is experienced as connected and coherent and is consistent with a patient's health needs and personal circumstances”. The total score of the questionnaire ranges from 6 to 30, higher score indicating higher continuity and a score &lt;24 indicating insufficient continuity. Cronbach's alpha on the total PCCQ was 0.94. Correlations between PCCQ and quality of life, depression, anxiety, perceived control and health care utilization were estimated using spearman rang correlation. Results Insufficient continuity of care ranged between 47% to 59% in the different diagnosis groups, which the highest continuity in the AMI group and lowest in patients with atrial fibrillation. In patients hospitalized due to AMI (n=355, mean age 71 (± 11), 70% men), continuity of care was related to higher perceived control, higher quality of life, a good financial situation, being a man, no symptoms of anxiety or depression (ᚹ range 0.17–0.26 p≤0.002). A low score on the PCCQ were associated with follow-up visit to a nurse in primary care after hospitalization (ᚹ −0.12 p=0.033). In patients hospitalized due to angina (n=210, mean age 73 (± 9), 74% men), continuity of care was related to higher perceived control, higher quality of life and no depressive symptoms (ᚹ range between 0.20 and 0.26 p=0.005). In patients with AF, (n=255, mean age 71 (± 10.), 58% men), continuity of care was related to having had contact by telephone with a nurse-led AF clinic, higher perceived control, higher quality of life and not being depressed (ᚹ range between 0.14–0.25 p=0.03). In patients with HF, (n=173, mean age 77 (±8) 59% men), continuity was related to male ender, younger age, follow-up in a nurse-led HF clinic and not being anxious (ᚹ range between 0.16 and 0.22 p=0.004–0.047). Low total score on PCCQ correlated to having had telephone contact with nurse in primary care (ᚹ −0.24 p=0.002). Conclusion Almost half of all patient reported insufficient continuity of care. Perceived control, quality of life, and symptoms of depression were related to higher continuity of care in all diagnose groups except heart failure. Further, there was a correlation between continuity and follow-up visits or contact by telephone with nurse-led clinics in all diagnose groups except angina. Funding Acknowledgement Type of funding source: Foundation. Main funding source(s): Medical Research Council of Southeast Sweden, Centre for Clinical Research Sörmland

Depression and Inflammatory Markers in Veterans With Multiple Sclerosis

2021 ◽  
pp. 109980042110500
Author(s):  
Pamela Newland ◽  
Yelyzaveta Basan ◽  
Ling Chen ◽  
Gregory Wu
Keyword(s):  
Multiple Sclerosis ◽  
Inflammatory Markers ◽  
Pearson Correlation ◽  
Correlation Coefficients ◽  
The United States ◽  
Biological Mechanisms ◽  
The Central Nervous System ◽  
Brain And Spinal Cord ◽  
The Brain

Multiple sclerosis (MS), an inflammatory neurodegenerative disease of the central nervous system (CNS), afflicts over one per thousand people in the United States. The pathology of MS typically involves lesions in several regions, including the brain and spinal cord. The manifestation of MS is variable and carries great potential to negatively impact quality of life (QOL). Evidence that inflammatory markers are related to depression in MS is accumulating. However, there are barriers in precisely identifying the biological mechanisms underlying depression and inflammation. Analysis of cytokines provides one promising approach for understanding the mechanisms that may contribute to MS symptoms. Methods: In this pilot study, we measured salivary levels of interleukin (IL)-6, IL-1beta (β), and IL-10 in 24 veterans with MS. Descriptive statistics were reported and Pearson correlation coefficients were obtained between cytokines and depression. Results: The anti-inflammatory cytokine IL-10 was significantly negatively associated with depression in veterans with MS (r = −0.47, p = .024). Conclusion: Cytokines may be useful for elucidating biological mechanisms associated with the depression and a measure for nurses caring for veterans with MS.

536 QUALITY OF LIFE AND FOLLOW-UP AFTER ESOPHAGEAL AND GASTRIC CANCER SURGERY. PROTOCOL FOR DEVELOPING AND TESTING A NEW FOLLOW-UP MODEL

2021 ◽  
Vol 34 (Supplement_1) ◽  
Author(s):  
I Hovdenak Jakobsen ◽  
D Kjaer
Keyword(s):  
Quality Of Life ◽  
Gastric Cancer ◽  
Adverse Effects ◽  
Prospective Study ◽  
Patient Involvement ◽  
Complex Interventions ◽  
National Implementation ◽  
Patient Reported

Abstract   Esophageal and gastric cancers are aggressive diseases. Due to extensive treatment, many patients experience adverse effects such as dysphagia, dumping, pain, fatigue, fear of recurrence and depression—all negatively impacting quality of life (QoL). The purpose of this study is to develop and test a follow-up model for patients after surgery for esophageal and gastric cancer. The model targets handling of adverse effects and psychosocial distress, aiming at improving patients’ QoL and functional level. Methods Development of the model follows recognized principles for complex interventions by the Medical Research Counsil. Extensive patient involvement is included in the development process, by means of a national patient advisory board. The assumed effect of the new model will be tested in a national two-part prospective study, executed before and after national implementation of the model, in both parts including approximately200 patients. Participants will be recruited prior to surgery, and follow-up is one year. Patient-reported data will be collected pre-operatively, at 3, 6, 9 and 12 months postoperatively, along with clinical and sociodemographic data. Results Development of the follow-up model after surgery will be completed in august 2020 and inclusion of patients for the prospective study part one, before implementation of the model, will commence summer 2020. Conclusion The perspectives of this study may be crucial for future follow-up of esophageal and gastric cancer patients. First, the extensive patient involvement in developing the model will ensure a patient-centred approach to follow-up. And second, the follow-up studies will provide important and up-to-date knowledge about clinical and patient-reported outcomes in a population-based, national cohort.

scholarly journals Correlations Between Clinical Trial Outcomes Based on Symptoms, Functional Impairments, and Quality of Life in Children and Adolescents With ADHD

2017 ◽  
Vol 23 (13) ◽  
pp. 1578-1591 ◽  
Author(s):  
David R. Coghill ◽  
Alain Joseph ◽  
Vanja Sikirica ◽  
Mark Kosinski ◽  
Caleb Bliss ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Children And Adolescents ◽  
Rating Scale ◽  
Controlled Trial ◽  
Pearson Correlation ◽  
Correlation Coefficients ◽  
Parent Report ◽  
Functional Impairments ◽  
Risk Avoidance

Objective: To assess relationships between treatment-associated changes in measures of ADHD symptoms, functional impairments, and health-related quality of life in children and adolescents with ADHD. Method: Pearson correlation coefficients were calculated post hoc for changes from baseline to endpoint in outcomes of one randomized, placebo- and active-controlled trial of lisdexamfetamine (osmotic-release methylphenidate reference) and one of guanfacine extended-release (atomoxetine reference). Results: Changes in ADHD Rating Scale IV (ADHD-RS-IV) total score generally correlated moderately with changes in Child Health and Illness Profile−Child Edition: Parent Report Form (CHIP-CE:PRF) Achievement and Risk Avoidance ( r ≈ .4), but weakly with Resilience, Satisfaction, and Comfort ( r ≈ .2); and moderately with Weiss Functional Impairment Rating Scale–Parent (WFIRS-P) total score ( r ≈ .5). CHIP-CE:PRF Achievement and Risk Avoidance correlated moderately to strongly with WFIRS-P total score ( r ≈ .6). Conclusion: The ADHD-RS-IV, CHIP-CE:PRF, and WFIRS-P capture distinct but interconnected aspects of treatment response in individuals with ADHD.

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