scholarly journals Functional outcomes after salvage procedures for the destroyed wrist: an overview

2019 ◽  
Vol 45 (1) ◽  
pp. 19-27 ◽  
Author(s):  
Michel E. H. Boeckstyns
Keyword(s):  
Patient Reported Outcomes ◽  
Functional Results ◽  
Well Being ◽  
Salvage Procedure ◽  
Proximal Row Carpectomy ◽  
Wrist Arthrodesis ◽  
Patient Reported ◽  
Surgical Options ◽  
The Common ◽  
Clinical Measurements

The most widely used procedures for salvaging a destroyed wrist are four-corner arthrodesis, radiocarpal arthrodesis, proximal row carpectomy, total wrist arthrodesis, and total wrist replacement or resurfacing. The purpose of this article is to give an overview of the functional results obtained with the various salvage procedures and of the common methods for assessing the surgical outcomes. The outcomes are assessed by clinical measurements and scoring methods, but the actual functional status and well-being of the patients should be presented together with patient-reported outcomes. No salvage procedure can restore entirely full wrist function. Understanding indications, risks, and the outcomes of these procedures would favour a better decision for surgery and help choose the proper treatment from among the surgical options discussed with patients.

scholarly journals Linguistic validation of the simplified Chinese version of the US National Cancer Institute’s patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE™)

BMC Cancer ◽  
2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Cheng KKF ◽  
S. A. Mitchell ◽  
N. Chan ◽  
E. Ang ◽  
W. Tam ◽  
...  
Keyword(s):  
Adverse Events ◽  
Cancer Patients ◽  
Patient Reported Outcomes ◽  
A Priori ◽  
Cognitive Interviews ◽  
Simplified Chinese ◽  
Patient Reported ◽  
The Us ◽  
The Common ◽  
Response Choices

Abstract Background The aim of this study was to translate and linguistically validate the U.S. National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™) into Simplified Chinese for use in Singapore. Methods All 124 items of the English source PRO-CTCAE item library were translated into Simplified Chinese using internationally established translation procedures. Two rounds of cognitive interviews were conducted with 96 cancer patients undergoing adjuvant treatment to determine if the translations adequately captured the PRO-CTCAE source concepts, and to evaluate comprehension, clarity and ease of judgement. Interview probes addressed the 78 PRO-CTCAE symptom terms (e.g. fatigue), as well as the attributes (e.g. severity), response choices, and phrasing of ‘at its worst’. Items that met the a priori threshold of ≥20% of participants with comprehension difficulties were considered for rephrasing and retesting. Items where < 20% of the sample experienced comprehension difficulties were also considered for rephrasing if better phrasing options were available. Results A majority of PRO-CTCAE-Simplified Chinese items were well comprehended by participants in Round 1. One item posed difficulties in ≥20% and was revised. Two items presented difficulties in < 20% but were revised as there were preferred alternative phrasings. Twenty-four items presented difficulties in < 10% of respondents. Of these, eleven items were revised to an alternative preferred phrasing, four items were revised to include synonyms. Revised items were tested in Round 2 and demonstrated satisfactory comprehension. Conclusions PRO-CTCAE-Simplified Chinese has been successfully developed and linguistically validated in a sample of cancer patients residing in Singapore.

scholarly journals Establishing a common metric for patient-reported outcomes in cancer patients: linking patient reported outcomes measurement information system (PROMIS), numerical rating scale, and patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE)

2020 ◽  
Vol 4 (1) ◽  
Author(s):  
Minji K. Lee ◽  
Benjamin D. Schalet ◽  
David Cella ◽  
Kathleen J. Yost ◽  
Amy C. Dueck ◽  
...  
Keyword(s):  
Information System ◽  
Adverse Events ◽  
Patient Reported Outcomes ◽  
Rating Scale ◽  
Measurement Information ◽  
Outcomes Measurement ◽  
T Score ◽  
Patient Reported ◽  
Measurement Information System ◽  
The Common

Abstract Background Researchers and clinicians studying symptoms experienced by people with cancer must choose from various scales. It would be useful to know how the scores on one measure translate to another. Methods Using item response theory (IRT) with the single-group design, in which the same sample answers all measures, we produced crosswalk tables linking five 0–10 numeric rating scale (NRS) and 15 items from Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE, scored on a 1–5 scale) to the T-Score metric of six different scales from the NIH Patient reported Outcomes Measurement Information System (PROMIS®). The constructs, for which we conducted linking, include emotional distress-anxiety, emotional distress-depression, fatigue, sleep disturbance, pain intensity, and pain interference. We tested the IRT linking assumption of construct similarity between measures by comparing item content and testing unidimensionality of item sets comprising each construct. We also investigated the correlation of the measures to be linked and, by inspecting standardized mean differences, whether the linkage is invariant across age and gender subgroups. For measures that satisfied the assumptions, we conducted linking. Results In general, an NRS score of 0 corresponded to about 38.2 on the PROMIS T-Score scale (mean = 50; SD = 10); whereas an NRS score of 10 corresponded to a PROMIS T-Score of approximately 72.7. Similarly, the lowest/best score of 1 on PRO-CTCAE corresponded to 39.8 on T-score scale and the highest/worst score of 5 corresponded to 72.0. Conclusion We produced robust linking between single item symptom measures and PROMIS short forms.

scholarly journals Comparison of Direct Surgical Costs for Proximal Row Carpectomy and Four-Corner Arthrodesis

2018 ◽  
Vol 08 (01) ◽  
pp. 066-071 ◽  
Author(s):  
Andrew Stephens ◽  
Angela Presson ◽  
Yizhe Xu ◽  
Ross Feller ◽  
Andrew Tyser ◽  
...  
Keyword(s):  
Patient Reported Outcomes ◽  
Operative Time ◽  
Tertiary Care ◽  
Proximal Row Carpectomy ◽  
Level Of Evidence ◽  
Surgical Costs ◽  
Patient Reported ◽  
Simultaneous Procedures ◽  
Supply Costs ◽  
Staple Fixation

Background Proximal row carpectomy (PRC) and four-corner arthrodesis (FCA) are common treatments for stage II scapholunate advanced collapse (SLAC) and scaphoid nonunion advanced collapse (SNAC) wrists, with similar functional and patient-reported outcomes reported in the peer-reviewed literature. Questions Study questions included (1) whether surgical encounter total direct costs (SETDCs) differ between PRC and FCA, and (2) whether SETDC differs by method of fixation for FCA. Patients and Methods Consecutive adult patients (≥ 18 years) undergoing PRC and FCA between July 2011 and May 2017 at a single tertiary care academic institution were identified. Patients undergoing additional simultaneous procedures were excluded. Using our institution's information technology value tools, we extracted prospectively collected cost data for each surgical encounter. SETDCs were compared between PRC and FCA, and between FCA subgroups (screws, plating, or staples). Results Of 42 included patients, mean age was similar between the 23 PRC and 19 FCA patients (51.2 vs. 54.5 years, respectively). SETDCs were significantly greater for FCA than PRC by 425%. FCA involved significantly greater facility costs (2.3-fold), supply costs (10-fold), and operative time (121 vs. 57 minutes). Implant costs were absent for PRC, which were responsible for 55% of the SETDC for FCA. Compared with compression screws, plating and staple fixation were significantly more costly (70% and 240% greater, respectively). Conclusion SETDCs were 425% greater for FCA than PRC. Implant costs for FCA alone were 130% greater than the entire surgical encounter for PRC. For FCA, SETDC varied depending on the method of fixation. Level of Evidence This is a level III, cost analysis study.

scholarly journals Web-Based Patient-Reported Outcome Measures for Personalized Treatment and Care (PROMPT-Care): Multicenter Pragmatic Nonrandomized Trial

10.2196/19685 ◽  
2020 ◽  
Vol 22 (10) ◽  
pp. e19685
Author(s):  
Afaf Girgis ◽  
Ivana Durcinoska ◽  
Anthony Arnold ◽  
Joseph Descallar ◽  
Nasreen Kaadan ◽  
...  
Keyword(s):  
Emergency Department ◽  
Patient Reported Outcomes ◽  
Well Being ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Self Management ◽  
Diverse Population ◽  
Web Based ◽  
Patients With Cancer ◽  
Patient Reported

Background Despite the acceptability and efficacy of e–patient-reported outcome (ePRO) systems, implementation in routine clinical care remains challenging. Objective This pragmatic trial implemented the PROMPT-Care (Patient Reported Outcome Measures for Personalized Treatment and Care) web-based system into existing clinical workflows and evaluated its effectiveness among a diverse population of patients with cancer. Methods Adult patients with solid tumors receiving active treatment or follow-up care in four cancer centers were enrolled. The PROMPT-Care intervention supported patient management through (1) monthly off-site electronic PRO physical symptom and psychosocial well-being assessments, (2) automated electronic clinical alerts notifying the care team of unresolved clinical issues following two consecutive assessments, and (3) tailored online patient self-management resources. Propensity score matching was used to match controls with intervention patients in a 4:1 ratio for patient age, sex, and treatment status. The primary outcome was a reduction in emergency department presentations. Secondary outcomes were time spent on chemotherapy and the number of allied health service referrals. Results From April 2016 to October 2018, 328 patients from four public hospitals received the intervention. Matched controls (n=1312) comprised the general population of patients with cancer, seen at the participating hospitals during the study period. Emergency department visits were significantly reduced by 33% (P=.02) among patients receiving the intervention compared with patients in the matched controls. No significant associations were found in allied health referrals or time to end of chemotherapy. At baseline, the most common patient reported outcomes (above-threshold) were fatigue (39%), tiredness (38.4%), worry (32.9%), general wellbeing (32.9%), and sleep (24.1%), aligning with the most frequently accessed self-management domain pages of physical well-being (36%) and emotional well-being (23%). The majority of clinical feedback reports were reviewed by nursing staff (729/893, 82%), largely in response to the automated clinical alerts (n=877). Conclusions Algorithm-supported web-based systems utilizing patient reported outcomes in clinical practice reduced emergency department presentations among a diverse population of patients with cancer. This study also highlighted the importance of (1) automated triggers for reviewing above-threshold results in patient reports, rather than passive manual review of patient records; (2) the instrumental role nurses play in managing alerts; and (3) providing patients with resources to support guided self-management, where appropriate. Together, these factors will inform the integration of web-based PRO systems into future models of routine cancer care. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12616000615482; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370633 International Registered Report Identifier (IRRID) RR2-10.1186/s12885-018-4729-3

scholarly journals Patient-reported outcomes in drug development for hematology

Hematology ◽  
2015 ◽  
Vol 2015 (1) ◽  
pp. 496-500 ◽  
Author(s):  
Catherine Acquadro ◽  
Antoine Regnault
Keyword(s):  
Clinical Trials ◽  
Drug Development ◽  
Patient Reported Outcomes ◽  
Clinical Decision Making ◽  
Well Being ◽  
New Drugs ◽  
Specific Situation ◽  
Treatment Benefit ◽  
Hematologic Diseases ◽  
Patient Reported

Abstract Patient-reported outcomes (PROs) are any outcome evaluated directly by the patient himself and based on the patient's perception of a disease and its treatment(s). PROs are direct outcome measures that can be used as clinical meaningful endpoints to characterize treatment benefit. They provide unique and important information about the effect of treatment from a patient's view. However, PROs will only be considered adequate if the assessment is well-defined and reliable. In 2009, the FDA has issued a guidance, which defines good measurement principles to consider for PRO measures intended to give evidence of treatment benefit in drug development. In hematologic clinical trials, when applied rigorously, they may be used to evaluate overall treatment effectiveness, treatment toxicity, and quality of patient's well-being at short-term and long-term after treatment from a patient's perspective. In situations in which multiple treatment options exist with similar survival outcome or if a new therapeutic strategy needs to be evaluated, the inclusion of PROs as an endpoint can provide additional data and help in clinical decision making. Given the diversity of the hematological field, the approach to measurement needs to be tailored for each specific situation. The importance of PROs in hematologic diseases has been highlighted in a number of international recommendations. In addition, new perspectives in the regulatory field will enhance the inclusion of PRO endpoints in clinical trials in hematology, allowing the voice of the patients with hematologic diseases to be taken into greater consideration in the development of new drugs.

Health-Related Quality of Life Measurement in Public Health

2021 ◽  
Vol 43 (1) ◽  
Author(s):  
Robert M. Kaplan ◽  
Ron D. Hays
Keyword(s):  
Public Health ◽  
Quality Of Life ◽  
Patient Reported Outcomes ◽  
Well Being ◽  
Publication Date ◽  
Health Related Quality ◽  
Patient Reported ◽  
Related Quality ◽  
Health Related

Patient-reported outcomes are recognized as essential for the evaluation of medical and public health interventions. Over the last 50 years, health-related quality of life (HRQoL) research has grown exponentially from 0 to more than 17,000 papers published annually. We provide an overview of generic HRQoL measures used widely in epidemiological studies, health services research, population studies, and randomized clinical trials [e.g., Medical Outcomes Study SF-36 and the Patient-Reported Outcomes Measurement Information System (PROMIS®)-29]. In addition, we review methods used for economic analysis and calculation of the quality-adjusted life year (QALY). These include the EQ-5D, the Health Utilities Index (HUI), the self-administered Quality of Well-being Scale (QWB-SA), and the Health and Activities Limitation Index (HALex). Furthermore, we consider hybrid measures such as the SF-6D and the PROMIS-Preference (PROPr). The plethora of HRQoL measures has impeded cumulative science because incomparable measures have been used in different studies. Linking among different measures and consensus on standard HRQoL measurement should now be prioritized. In addition, enabling widespread access to common measures is necessary to accelerate future progress. Expected final online publication date for the Annual Review of Public Health, Volume 43 is April 2022. Please see http://www.annualreviews.org/page/journal/pubdates for revised estimates.

Patient-Reported Outcomes in Cancer Clinical Trials: Measuring Symptomatic Adverse Events With the National Cancer Institute’s Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

2016 ◽  
pp. 67-73 ◽  
Author(s):  
Paul G. Kluetz ◽  
Diana T. Chingos ◽  
Ethan M. Basch ◽  
Sandra A. Mitchell
Keyword(s):  
Clinical Trials ◽  
Adverse Events ◽  
Patient Reported Outcomes ◽  
Patient Perspective ◽  
Cancer Clinical Trials ◽  
Cancer Therapies ◽  
Systematic Assessment ◽  
Promising Tool ◽  
Patient Reported ◽  
The Common

Systematic capture of the patient perspective can inform the development of new cancer therapies. Patient-reported outcomes (PROs) are commonly included in cancer clinical trials; however, there is heterogeneity in the constructs, measures, and analytic approaches that have been used making these endpoints challenging to interpret. There is renewed effort to identify rigorous methods to obtain high-quality and informative PRO data from cancer clinical trials. In this setting, PROs are used to address specific research objectives, and an important objective that spans the product development life cycle is the assessment of safety and tolerability. The U.S. Food and Drug Administration’s (FDA) Office of Hematology and Oncology Products (OHOP) has identified symptomatic adverse events (AEs) as a central PRO concept, and a systematic assessment of patient-reported symptomatic AEs can provide data to complement clinician reporting. The National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) is being evaluated by multiple stakeholders, including the FDA, and is considered a promising tool to provide a standard yet flexible method to assess symptomatic AEs from the patient perspective. In this article, we briefly review the FDA OHOP’s perspective on PROs in cancer trials submitted to the FDA and focus on the assessment of symptomatic AEs using PRO-CTCAE. We conclude by discussing further work that must be done to broaden the use of PRO-CTCAE as a method to provide patient-centered data that can complement existing safety and tolerability assessments across cancer clinical trials.

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