Does physical function impact the acceptability of routine patient-reported outcome surveys in cancer patients?

2016 ◽  
Vol 34 (7_suppl) ◽  
pp. 67-67
Author(s):  
Lauren Wong ◽  
Catherine Brown ◽  
Andrea Perez-Cosio ◽  
Yvonne Leung ◽  
Mindy Liang ◽  
...  
Keyword(s):  
Physical Function ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Clinic Visit ◽  
Routine Screening ◽  
Limiting Factors ◽  
Related Symptom ◽  
Patient Reported ◽  
Routine Basis ◽  
Caucasian Patients

67 Background: Patient-reported outcome measures (PROMs) are used to collect cancer-related symptom and symptomatic toxicity data. Understanding factors that affect the acceptability of PROMs is useful for improving the participation of such routine screening practices. We investigated the association between patient’s functional status on their acceptance and perception of usefulness of tablet technology to routine collection of PROM data in the clinical setting. Methods: 279 adult cancer outpatients at Toronto’s Princess Margaret Cancer Centre completed two physical function surveys, the HAQ-DI and WHODAS, using touchscreen tablet technology. Patient socio-demographics and their willingness of completing PROMs on a routine basis were also collected. Results: The median age was 62 (range: 20–94); 50% male, and 68% Caucasian. Patients were recruited from breast (10.4%), gastrointestinal (10.4%), genitourinary (14%), gynecology (14.3%), head & neck (17.9%), hematology (17.6%), and thoracic (15.4%) cancer clinics. 87% were willing to complete the survey on a touchscreen tablet, 74% did not find it time-consuming, and 4% found completion of the survey made their clinic visit more difficult. Only 1% found the questions upsetting or distressful; however, less than 60% were willing to complete similar surveys at every visit. Being Caucasian (p = 0.015) and Canadian-born (p = 0.021) were significantly associated with acceptability of the survey on a regular basis. However, HAQ-DI and WHODAS are not significantly associated with willingness to complete PROMs regularly (p = 0.30 & p = 0.16 respectively). Conclusions: Physical function status is not associated with acceptability; however, ethnicity does play a role where Canadian-born and Caucasian patients are more likely to complete PROMs regularly. Despite this, over 40% of patients were not willing to fill in the PROMs at each visit. Socio-cultural factors may impact on patients’ perceptions of the value of routine screening; however, assessment burden may also limit willingness to complete surveys on an ongoing basis. Further research is underway to gain more insight into the limiting factors of patients to complete the survey routinely.

Patient-reported outcomes in PD-1/PD-L1 inhibitor registration trials: FDA analysis of data submitted and future directions.

2018 ◽  
Vol 36 (5_suppl) ◽  
pp. 134-134 ◽  
Author(s):  
Lynn Jackson Howie ◽  
Harpreet Singh ◽  
Bellinda King-Kallimanis ◽  
Jessica Roydhouse ◽  
Marc Robert Theoret ◽  
...  
Keyword(s):  
Physical Function ◽  
Patient Experience ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Symptom Scale ◽  
Open Label ◽  
Benefit Risk Assessment ◽  
Patient Reported ◽  
Lung Cancer Symptom Scale ◽  
Eortc Qlq

134 Background: Patient-reported outcome measures (PROs) can capture the patient’s experience with disease and treatment. Anti-PD-1/PD-L1 therapies have unique symptomatic side effects; PRO data can help to better understand the patient experience on therapy. Health-related quality of life (HRQL) components most impacted by therapy include disease symptoms, symptomatic toxicity and physical function. Methods: We reviewed FDA registration trials for 5 immunotherapy agents (anti-PD-1/PD-L1) to evaluate trial design and PRO assessment. We assessed whether the PRO strategy assessed physical function and symptomatic immune-related adverse events (irAEs) by reviewing whether trials used a well-defined physical function domain and 8 symptoms related to irAEs reported in product labels (fatigue, diarrhea, cough, shortness of breath, musculoskeletal pain, rash, pruritis and fever). Results: Data from 25 trials across 7 disease types and 1 tumor agnostic indication were evaluated. Of these, 13 were randomized and 22 were open label. Eighteen of 25 contained PRO assessments and all 18 used > 1 instrument. The most common instruments were the EQ-5D (N = 17), followed by EORTC QLQ-C30 (N = 15). Disease-specific PRO tools were included in 8 trials (5 lung, 1 head and neck, 1 melanoma and 1 renal cell), consisting of modules or scales from EORTC (N = 5), FACIT (N = 2) or the Lung Cancer Symptom Scale (N = 1). Sixty percent of the trials (15/25) used an instrument that contained a well-defined physical function (PF) domain. No trial used a PRO strategy assessing all 8 selected symptoms related to irAEs. Conclusions: Collection of PRO data in anti-PD-1/PD-L1 trials submitted to FDA was variable, and did not consistently assess treatment related symptoms and physical function. Use of a HRQL tool with well-defined functional scales supplemented by item banks or libraries to incorporate symptoms associated with irAEs may improve understanding of the patient experience while receiving anti-PD-1/PD-L1 treatment. These data, along with other important clinical data such as hospitalizations, ER visits and supportive care medications can inform the benefit risk assessment for regulatory purposes.

scholarly journals First steps in PROMs and PREMs collection in Wales as part of the prudent and value-based healthcare agenda

2020 ◽  
Author(s):  
Kathleen Withers ◽  
Robert Palmer ◽  
Sally Lewis ◽  
Grace Carolan-Rees
Keyword(s):  
Effective Means ◽  
Patient Reported Outcome Measures ◽  
Care Patient ◽  
Patient Reported Outcome ◽  
Clinic Visit ◽  
Research Centre ◽  
Service Improvement ◽  
Health Board ◽  
Technical Requirements ◽  
Patient Reported

Abstract Purpose Patients are experts in their own health and should be treated as equal partners in their care. Patient-reported outcome measures (PROMs) are an effective way of gathering patient feedback and can facilitate effectiveness and cost-effectiveness analysis to improve decision making and service improvement. The PROMs, PREMs & Effectiveness Programme was initiated in 2016 and aimed to develop an electronic platform to facilitate collection of PROMs and Patient-reported experience measures (PREMs) from secondary care patients across Wales. Methods We worked with all Health Boards in Wales, the NHS Wales Informatics Service (NWIS), and Cedar (a healthcare technology research centre) to identify and meet technical requirements to develop a platform which is fit for purpose. Patient groups were included throughout the development to gather feedback and for extensive testing. Clinical teams helped identify the most appropriate tools, with licences, translations and electronic formatting issues being managed centrally. Results The developed platform is integrated with patient administration systems minimising the need for manual input, with processes in place to allow automatic collection triggers according to nationally agreed schedules. We have over 30 nationally agreed PROMs ‘pathways’ with over 110,000 PROMs collected to date. Responses are fed back to clinicians via the electronic patient record and to each health board via feeds to the national data warehouse, making data easily accessible to different teams, maximising use and application. Discussion The national platform has provided a co-ordinated approach to PROMs collection in Wales, offering an effective means of communicating with patients outside the traditional clinic visit.

scholarly journals Sex differences in postural orientation errors and association with objective and patient-reported function in patients with ACL injury: an exploratory cross-sectional study

2021 ◽  
Vol 7 (2) ◽  
pp. e001045
Author(s):  
Jenny Nae ◽  
Mark W Creaby ◽  
Anna Cronström ◽  
Eva Ageberg
Keyword(s):  
Sex Differences ◽  
Physical Function ◽  
Cruciate Ligament ◽  
Visual Assessment ◽  
Patient Reported Outcome Measures ◽  
Cross Sectional Study ◽  
Patient Reported Outcome ◽  
Cross Sectional ◽  
Patient Reported ◽  
Postural Orientation

ObjectivesThere is limited research on sex differences in postural orientation (ie, alignment between body segments) in people with knee injury measured with a clinically applicable method. An understanding of the relationship between postural orientation and physical function may help guide decision making in rehabilitation. The aims were to evaluate (1) sex differences in visual assessment of Postural Orientation Errors (POEs) and (2) the association between POEs and objective and patient-reported physical function, in men and women with anterior cruciate ligament reconstruction (ACLR).MethodsTwenty-four women and 29 men (mean 26.7 (SD 6.5) years) with ACLR were included. Six POEs (lower extremity and trunk) were scored from a video of five tasks with varying difficulty to compute POE scores (total and subscores). Objective physical function was evaluated with the single-leg hop for distance and side hop. Patient-reported physical function was evaluated using patient-reported outcome measures (PROMs).ResultsWomen had significantly more POEs than men (median difference 5.5–25, p≤0.028). More POEs were associated with shorter hop distance and fewer side hops in women (rs= −0.425 to −0.518, p<0.038), but not in men (rs<0.301, p>0.05). No associations were found between POE scores and PROMs, in either sex (rs< –0.246, p>0.05).ConclusionsWomen with ACLR seem to have more POEs compared with men, indicating worse postural orientation. More POEs were associated with worse hop performance, suggesting that POE scores may be used as criteria for rehabilitation progression. The lack of associations between POE scores and PROMs indicate that these measures complement each other.

Patient Acceptable Symptom State in Knee Osteoarthritis Patients Succeeds Across Different Patient-reported Outcome Measures Assessing Physical Function, But Fails Across Other Dimensions and Rheumatic Diseases

2017 ◽  
Vol 45 (1) ◽  
pp. 122-127 ◽  
Author(s):  
Elien A.M. Mahler ◽  
Nadine Boers ◽  
Johannes W.J. Bijlsma ◽  
Frank H.J. van den Hoogen ◽  
Alfons A. den Broeder ◽  
...  
Keyword(s):  
Knee Osteoarthritis ◽  
Physical Function ◽  
Outcome Measures ◽  
Rheumatic Diseases ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Knee Oa ◽  
Cutoff Values ◽  
Patient Reported ◽  
Patient Acceptable Symptom State

Objective.The aims of this study are (1) to establish the Patient Acceptable Symptom State (PASS) cutoff values of different patient-reported outcome measures (PROM) assessing physical function in patients with knee osteoarthritis (OA), and (2) to assess the influence of sex, age, duration of symptoms, and presence of depressive feelings on being in PASS.Methods.Patients fulfilling the clinical American College of Rheumatology knee OA criteria received standardized nonsurgical treatment and completed different questionnaires at baseline and 3 months assessing physical function: Knee Injury and Osteoarthritis Outcome Score, Lequesne Algofunctional Index, Lower Extremity Functional Scale, numerical rating scale, and the physical function subscale of the Western Ontario and McMaster Universities Osteoarthritis Index. PASS values were defined as the 75th percentile of the score of questionnaires for those patients who consider their state acceptable.Results.Of the 161 included patients, 62% were women with a mean age of 59 years (SD 9) and body mass index of 30 kg/m2 (SD 5). Standardized PASS values (95% CI) for different questionnaires for physical function varied between 48 (44–54) and 54 (50–56). Female patients and patients feeling depressed were found to have a lower probability to be in PASS for physical function, with OR (95% CI) varying from 0.45 (0.23–0.91) to 0.50 (0.26–0.97) and from 0.27 (0.14–0.55) to 0.38 (0.19–0.77), respectively.Conclusion.PASS cutoff values for physical function are robust across different PROM in patients with knee OA. Our results indicate that PASS values are not consistent across dimensions and rheumatic diseases, and that the use of a generic PASS value for patients with OA or even patients with other rheumatic diseases might not be justifiable.

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