scholarly journals Patient-Reported Outcomes Over 5 Years After Whole- or Partial-Breast Radiotherapy: Longitudinal Analysis of the IMPORT LOW (CRUK/06/003) Phase III Randomized Controlled Trial

2019 ◽  
Vol 37 (4) ◽  
pp. 305-317 ◽  
Author(s):  
Indrani S. Bhattacharya ◽  
Joanne S. Haviland ◽  
Anna M. Kirby ◽  
Cliona C. Kirwan ◽  
Penelope Hopwood ◽  
...  
Keyword(s):  
Rate Ratio ◽  
Incidence Rate Ratio ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Breast Radiotherapy ◽  
Reduced Dose ◽  
Whole Breast Radiotherapy ◽  
Patient Reported ◽  
Partial Breast Radiotherapy ◽  
Over Time

Purpose IMPORT LOW demonstrated noninferiority of partial-breast and reduced-dose radiotherapy versus whole-breast radiotherapy for local relapse and similar or reduced toxicity at 5 years. Comprehensive patient-reported outcome measures collected at serial time points are now reported. Patients and Methods IMPORT LOW recruited women with low-risk breast cancer after breast-conserving surgery. Patients were randomly assigned to 40 Gy whole-breast radiotherapy (control), 36 Gy whole-breast and 40 Gy partial-breast radiotherapy (reduced-dose), or 40 Gy partial-breast radiotherapy only (partial-breast) in 15 fractions. European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires Core 30 and Breast Cancer–Specific Module, Body Image Scale, protocol-specific items, and the Hospital Anxiety and Depression Scale were administered at baseline, 6 months, and 1, 2, and 5 years. Patterns of moderate/marked adverse effects (AEs) were assessed using longitudinal regression models, and baseline predictors were investigated. Results A total of 41 of 71 centers participated in the patient-reported outcome measures substudy; 1,265 (95%) of 1,333 patients consented, and 557 (58%) of 962 reported no moderate/marked AEs at 5 years. Breast appearance change was most prevalent and persisted over time (approximately 20% at each time point). Prevalence of breast hardness, pain, oversensitivity, edema, and skin changes reduced over time ( P < .001 for each), whereas breast shrinkage increased ( P < .001). Analysis by treatment group showed average number of AEs per person was lower in partial-breast (incidence rate ratio, 0.77; 95% CI, 0.71 to 0.84; P < .001) and reduced-dose (incidence rate ratio, 0.83; 95% CI, 0.76 to 0.90; P < .001) versus whole-breast group and decreased over time in all groups. Younger age, larger breast size/surgical deficit, lymph node positivity, and higher levels of anxiety/depression were baseline predictors of subsequent AE reporting. Conclusion Most AEs reduced over time, with fewer AEs in the partial-breast and reduced-dose groups. Baseline predictors for AE reporting were identified. These findings will facilitate informed discussion and shared decision making for future patients receiving moderately hypofractionated breast radiotherapy.

scholarly journals Patient‐reported outcome measures ( PROMs ): making sense of individual PROM scores and changes in PROM scores over time

Nephrology ◽  
2020 ◽  
Author(s):  
Esmee M. Willik ◽  
Caroline B. Terwee ◽  
Willem Jan W. Bos ◽  
Marc H. Hemmelder ◽  
Kitty J. Jager ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Making Sense ◽  
Patient Reported ◽  
Over Time

scholarly journals A Systematic Review of Patient-Reported Outcome Measures Assessing Body Image Disturbance in Patients with Head and Neck Cancer

2019 ◽  
Vol 160 (6) ◽  
pp. 941-954 ◽  
Author(s):  
Mark A. Ellis ◽  
Katherine R. Sterba ◽  
Emily A. Brennan ◽  
Stacey Maurer ◽  
Elizabeth G. Hill ◽  
...  
Keyword(s):  
Systematic Review ◽  
Body Image ◽  
Head And Neck Cancer ◽  
Head And Neck ◽  
Treatment Strategies ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Body Image Disturbance ◽  
Patient Reported ◽  
Over Time

Objective To synthesize published literature describing the severity of body image disturbance (BID) in patients with head and neck cancer (HNC) over time, its psychosocial and functional associations, and treatment strategies as assessed by patient-reported outcome measures (PROMs). Data Source PubMed/MEDLINE, Scopus, PsycINFO, Web of Science, and Google Scholar. Review Methods A systematic review of the English-language literature was performed to identify studies of BID in patients with HNC using psychometrically validated PROMs to assess (1) severity of BID over time, (2) psychosocial and functional associations, and (3) management strategies. Results A total of 17 studies met inclusion criteria. BID was assessed via 10 different PROMs, none of which were HNC-specific measures of BID. Two of 2 longitudinal studies (100%) reported that BID improved from pretreatment to posttreatment, and 2 of 3 longitudinal studies (67%) showed that the severity of BID decreased over time as survivors got further out from treatment. Seven of 17 studies (41%) described negative functional and psychosocial associations with BID, although study methodology limited conclusions about cause and effect. None of the studies assessing interventions to manage BID (0/2, 0%) demonstrated an improvement in BID relative to control. Conclusion BID in patients with HNC has negative functional and psychosocial associations and lacks evidence-based treatment. Research is limited by the lack of an HNC-specific BID PROM. Further research should address knowledge gaps related to the lack of an HNC-specific BID PROM, longitudinal course of BID in patients with HNC, confusion with regards to risk factors and outcomes, and lack of prevention and treatment strategies.

scholarly journals Changes in pulmonary function and patient-reported outcomes during COVID-19 recovery: a longitudinal, prospective cohort study

2021 ◽  
pp. 00243-2021
Author(s):  
Aditi S. Shah ◽  
Min Hyung Ryu ◽  
Cameron J Hague ◽  
Darra T. Murphy ◽  
James C. Johnston ◽  
...  
Keyword(s):  
Pulmonary Function ◽  
Symptom Onset ◽  
Prospective Cohort ◽  
Pulmonary Function Tests ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Considerable Proportion ◽  
Patient Reported ◽  
Underlying Mechanisms ◽  
Over Time

ObjectivesTo compare respiratory and patient-reported outcome measures (PROMs) between 3 and 6 months after symptom onset and to identify features that predict these changes.MethodsThis is a consecutive prospective cohort of 73 patients who were hospitalised with COVID-19. We evaluated the changes in pulmonary function tests (PFTs) and PROMs between 3 and 6 months and then investigated the associations between outcomes (change in diffusing capacity for carbon monoxide of the lung (DLCO), dyspnea, and quality of life (QOL)) and clinical and radiological features.ResultsThere was improvement in forced vital capacity (FVC), total lung capacity (TLC), and DLCO between 3 and 6 months by 3.25%, 3.82% and 5.69% respectively; however, there was no difference in PROMs. Reticulation and total CT scores were associated with lower DLCO %-predicted at 6 months (coefficients; −8.7 and −5.3 respectively). The association between radiological scores and DLCO were modified by time, with the degree of association between ground glass and DLCO having decreased markedly over time. There was no association between other predictors and change in dyspnea or QOL over time.ConclusionsThere is improvement in pulmonary function measurements between 3 and 6 months after COVID-19 symptom onset; however, PROMs did not improve. A higher reticulation and total CT score are negatively associated with DLCO, but this association is attenuated over time. Lastly, there is a considerable proportion of patients with unexplained dyspnea at 6 months, motivating further research to identify the underlying mechanisms.

scholarly journals The Use of Patient-Reported Outcome Measures in Phase I Oncology Clinical Trials

Oncology ◽  
2021 ◽  
pp. 1-10
Author(s):  
Robert L. Coleman ◽  
J. Thaddeus Beck ◽  
Joaquina C. Baranda ◽  
Ira Jacobs ◽  
Karen E. Smoyer ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Phase I ◽  
Outcome Measures ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Patient Reported ◽  
Oncology Clinical Trials ◽  
Changes Over Time ◽  
Over Time

<b><i>Objective:</i></b> To investigate patient-reported outcome (PRO) usage in phase I oncology clinical trials, including types of PRO measures and changes over time. <b><i>Methods:</i></b> We analyzed ClinicalTrials.gov records of phase I oncology clinical trials completed by December 2019. <b><i>Results:</i></b> Of all eligible trials, 2.3% (129/5,515) reported ≥1 PRO, totaling 181 instances of PRO usage. PRO usage increased over time, from 0.6% (trials initiated before 2000) to 3.4% (trials starting between 2015 and 2019). The most common PRO measures were unspecified (29%), tumor-specific (24%), and generic cancer (19%). <b><i>Conclusion:</i></b> Although uncommon in phase I oncology clinical trials, PRO usage is increasing over time. PRO measures were often unspecified on ClinicalTrials.gov, suggesting that more precise reporting and standardization are needed.

scholarly journals P494 Can Patients Monitor Response To Ustekinumab In The Real World?

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S477-S478
Author(s):  
A J Walsh ◽  
L Matini ◽  
A Kormilitzin ◽  
J Wilson ◽  
S Lyden ◽  
...  
Keyword(s):  
Abdominal Pain ◽  
Real Time ◽  
Decision Support Tool ◽  
Well Being ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Support Tool ◽  
Patient Reported ◽  
Reported Data ◽  
Over Time

Abstract Background Real time monitoring of patients with Crohn’s disease (CD) gives us the opportunity to examine disease trajectory. We have demonstrated the feasibility of using a monitoring platform with patient reported data, collected prospectively and routinely in clinical practice. The question is whether it can be used for specific drugs Methods TrueColours-IBD (TC-IBD)is a real time, web based platform that through email prompts linked to questionnaires, collects longitudinal patient reported outcome measures (for CD, symptoms measured by Harvey Bradshaw Index (HBI) and quality of life by IBD Control-8). It is routinely used by &gt;2000 patients in Oxford. This study examined 114 patients with Crohn’s: 45 males (median age 36, IQR 28–51) and 69 females (median age 34.8, IQR 28–47), treated with ustekinumab for a maximum of 16 months (range -2 months to 14 months). A linear mixed-effects model was used to approximate longitudinal trends of HBI and IBD Control-8. 3 individual items of the HBI scale (general well-being, abdominal pain & stool frequency) were also assessed. The TC-IBD platform has the capacity to analyse and show patients’ data automatically, using customised models and algorithms through the feedback loop (Fig 1). Model coefficients, intercept and slope were estimated using the restricted maximum likelihood (REML) approach. The intercept corresponds to the expected cohort mean value of the scale (e.g. HBI, IBD Control-8) at baseline (time zero) and the slope describes the rate of the change over time Results The models’ coefficients, the intercept and slope of both HBI and IBD Control-8 scales were statistically significant and are summarised in Table 1 with confidence intervals. Both linear trends (slopes) describing HBI (p&lt;0.001) and IBD Control-8 (p&lt;0.001) confirmed improvements for patients. The bowel movement component of the HBI dominated over general well-being and abdominal pain, while keeping a similar downward trend over time ( Fig 2 and Fig 3a,b) Conclusion Patient reported data through the TC-IBD platform can be used for statistical analyses and continuous monitoring of drug effect over time. This analysis is limited by a lack of comparator group, but the models may be used with the TrueColours platform as a decision support tool for other drugs

scholarly journals Testing the Responsiveness of and Defining Minimal Important Difference (MID) Values for the CARe Burn Scales: Patient-Reported Outcome Measures to Assess Quality of Life for Children and Young People Affected by Burn Injuries, and Their Parents/Caregivers

2021 ◽  
Vol 2 (4) ◽  
pp. 249-280
Author(s):  
Catrin Griffiths ◽  
Philippa Tollow ◽  
Danielle Cox ◽  
Paul White ◽  
Timothy Pickles ◽  
...  
Keyword(s):  
Young People ◽  
Burn Injury ◽  
Minimal Important Difference ◽  
Patient Reported Outcome Measures ◽  
Young Person ◽  
Patient Reported Outcome ◽  
Change Over Time ◽  
Patient Reported ◽  
Assess Quality ◽  
Over Time

The CARe Burn Scales are a portfolio of burn-specific PROMs for people affected by burns, including a Child Form (for children < 8 years (parent-proxy)), a Young Person Form (for young people aged 8–17 years), an Adult Form, and a Parent Form (for parents/carers of children aged 0–17 years). This study aimed to determine the responsiveness and minimal important difference (MID) values of the three scales developed for use in paediatric burn services and research. Participants were recruited by 15 UK Burn Services. Participants completed the appropriate CARe Burn Scale and a set of appropriate comparison validated measures, at three time points: 4 weeks (T1), 3 months (T2) and 6 months (T3) post-burn injury. Spearman’s correlation analysis and effect sizes based on Cohen’s d thresholds were reported and MID values were calculated. At baseline, 250 participants completed the Child Form, 69 completed the Young Person Form, and 320 completed the Parent Form. A total of 85–92% of participants were retained at follow up. The tested CARe Burn Scales were all responsive to change over time. MID values were created for all subscales and ranged from 2 to 11 for the Child Form, 3 to 14 for the Young Person Form and 3 to 10 for the Parent Form. The CARe Burn Scales for children, young people and parents are responsive to change over time. The scales are freely available for clinical and research use.

Patient-reported outcome measures for patients with cerebral aneurysms acquired via social media: data from a large nationwide sample

2014 ◽  
Vol 8 (1) ◽  
pp. 42-46 ◽  
Author(s):  
Michael Chen ◽  
Erwin Mangubat ◽  
Bichun Ouyang
Keyword(s):  
Social Media ◽  
Cerebral Aneurysm ◽  
Outcome Measures ◽  
Study Design ◽  
Cerebral Aneurysms ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Physical Impairment ◽  
Patient Reported ◽  
Over Time

BackgroundWith greater survival rates, patient-reported outcome measures (PROMs) among survivors of ruptured cerebral aneurysm should be an increasing concern among neurointerventionalists. Prior studies were limited in scale and generalizability. Our study aims were to (1) evaluate the validity of cerebral aneurysm PROMs obtained from social media; (2) determine the persistence of PROMs over time; and (3) determine what PROMs still exist in those with no physical impairments.MethodsBy engaging national brain aneurysm support groups and using an online questionnaire modeled after the generic EQ-5D instrument, we asked respondents to classify their health in five dimensions including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a 3-point Likert scale.ResultsIn 2 months we received 604 responses from 46 states in the USA. Our cohort of ruptured aneurysm respondents reported PROMs similar to previously published series. Over time, headache and anxiety improved while depression, level of exercise, and return to work remained unchanged. We found that memory worsened after 2 years. Among those without any physical impairment, rates of 20.6%, 14.9%, 12.6%, and 23% were seen for significant headaches, significant memory loss, significant depression, and sense of life being negatively affected, respectively.ConclusionsDespite this novel study design, we obtained results comparable to prior studies. These results suggest that many patients with ruptured cerebral aneurysms, regardless of whether they are >2 years after the event and/or free of physical impairment, struggle with a poor quality of life. The latency, scale, and low cost of this study design may accelerate future cerebral aneurysm PROM research.

Sign in / Sign up

Export Citation Format

Share Document