Patient Related Outcome Measures最新文献

Purpose: Disturbance of consciousness is common in patients with severe anti-N-methyl-D-aspartate receptor (NMDAR) encephalitis. However, little is known about it. This study aimed to analyze the clinical manifestations and prognostic factors of anti-NMDAR encephalitis with disturbance of consciousness.

Methods: In this retrospective study, the clinical features, treatment results, and long-term outcomes of anti-NMDAR encephalitis patients with disturbance of consciousness were analyzed, and multivariate logistic regression was used to analyze the factors affecting their prognosis.

Results: In the group with disturbance of consciousness, the incidences of seizures, involuntary movements, pulmonary infection, mechanical ventilation, intensive care unit (ICU) admission, neutrophil-lymphocyte ratio (NLR), abnormal cerebrospinal fluid index, plasma exchange, and immunosuppressive therapy were higher than those in the group without disturbance of consciousness (all P<0.05). During the follow-up period (median: 36 months, range: 12-78 months), the modified Rankin scale (mRS) score, the maximum mRS score during hospitalization, the mRS score at discharge, and the mRS score at 12 months after discharge were higher in the disturbance of consciousness group (all P < 0.001). However, there was no significant difference in long-term outcomes and recurrence between the two groups. Multivariate logistic regression analysis showed that mechanical ventilation, elevated IgG index, and delayed immunotherapy were independent risk factors for poor outcomes in patients with anti-NMDAR encephalitis with disturbance of consciousness at 12 months (odds ratio: 22.591, 39.868, 1.195). The receiver operating characteristics (ROC) curve analysis showed that the area under the curve (AUC) of mechanical ventilation, elevated IgG index, and delayed immunotherapy was 0.971 (95% CI=0.934-1.000, P<0.001).

Conclusion: Mechanical ventilation, elevated IgG index, and delayed immunotherapy may be the influencing factors of poor prognosis of anti-NMDAR encephalitis patients with disturbance of consciousness. Although their condition is relatively serious, most patients with anti-NMDAR encephalitis with disturbance of consciousness will achieve favorable long-term outcomes after long-term treatment.

Introduction: Decision aids are effective tools in facilitating patient-centered care and patient involvement in the decision-making process. Given unique barriers to providing patient-centered care for Veterans, implementation of decision aids may improve overall quality of care. We aimed to assess the acceptability and feasibility of video-based and pamphlet-based decision aid use in Veterans with knee osteoarthritis.

Materials and methods: Veterans considering treatment for knee osteoarthritis received either an online video-based aid, pamphlet-based aid, or both before their surgical consult. At their visit, patients completed written pre-visit and post-visit questionnaires. The pre-visit questionnaire included questions about the patient's demographics, decision-making preferences, experiences using the assigned decision aids, and the Hip-Knee Decision Quality Instrument. The post-visit questionnaire assessed the patient's overall experience with the decision-making process and how use of the decision aid influenced their discussion with the physician.

Results: All 16 patients who received the pamphlet-based aid reviewed the decision aid before their visit, compared to only five of the 12 patients who received the video-based aid. Thirteen of 20 patients indicated that they preferred to share treatment decision-making with their physician. Seventeen of 20 patients believed they would feel comfortable questioning the treatment recommendation of their surgeon after decision aid use. Most patients reported a positive experience using their decision aid, regardless of modality, and found it easily comprehensible and useful in visit preparation. A preference for a pamphlet-based aid was expressed by the majority of patients.

Conclusion: Veterans considering treatment for knee osteoarthritis are well prepared to engage in a patient-centered care experience. Most patients preferred sharing the decision-making process with their physician and felt comfortable questioning them about treatment recommendations. Decision aids helped Veterans feel more informed about their treatment options and improved engagement and discussion with their physician. Pamphlet-based aids were utilized more reliably than video-based aids.

Reliability and measurement error are measurement properties that quantify the influence of specific sources of variation, such as raters, type of machine, or time, on the score of the individual measurement. Several designs can be chosen to assess reliability and measurement error of a measurement. Differences in design are due to specific choices about which sources of variation are varied over the repeated measurements in stable patients, which potential sources of variation are kept stable (ie, restricted), and about whether or not the entire measurement instrument (or measurement protocol) was repeated or only part of it. We explain how these choices determine how intraclass correlation coefficients and standard errors of measurement formulas are built for different designs by using Venn diagrams. Strategies for improving the measurement are explained, and recommendations for reporting the essentials of these studies are described. We hope that this paper will facilitate the understanding and improve the design, analysis, and reporting of future studies on reliability and measurement error of measurements.

Systemic AL (light chain) amyloidosis is a rare protein misfolding disorder associated with plasma cell dyscrasia affecting various organs leading to organ dysfunction and failure. The Amyloidosis Forum is a public-private partnership between the Amyloidosis Research Consortium and the US Food and Drug Administration Center for Drug Evaluation and Research with the goal of accelerating the development of effective treatments for AL amyloidosis. In recognition of this goal, 6 individual working groups were formed to identify and/or provide recommendations related to various aspects of patient-relevant clinical trial endpoints. This review summarizes the methods, findings, and recommendations of the Health-Related Quality of Life (HRQOL) Working Group. The HRQOL Working Group sought to identify existing patient-reported outcome (PRO) assessments of HRQOL for use in clinical trials and practice deemed relevant across a broad spectrum of patients with AL amyloidosis. A systematic review of the AL amyloidosis literature identified 1) additional signs/symptoms not currently part of an existing conceptual model, and 2) relevant PRO instruments used to measure HRQOL. The Working Group mapped content from each identified instrument to areas of impact in the conceptual model to determine which instrument(s) provide coverage of relevant concepts. The SF-36v2^® Health Survey (SF-36v2; QualityMetric Incorporated, LLC) and Patient-Reported Outcomes Measurement Information System-29 Profile (PROMIS-29; HealthMeasures) were identified as instruments relevant to patients with AL amyloidosis. Existing evidence of reliability and validity was evaluated with a recommendation for future work focused on estimating clinically meaningful within-patient change thresholds for these instruments. For sponsors, the context of use-including specific research objectives, trial population, and investigational product under study-should inherently drive selection of the appropriate PRO instrument and endpoint definitions to detect meaningful change and enable patient-focused drug development.

Objective: This systematic review aimed to assess the adequacy of measurement properties in Patient-Reported Outcome Measures (PROMs) used to quantify psychosocial consequences of colorectal cancer screening among adults at average risk.

Methods: We searched four databases for eligible studies: MEDLINE, CINAHL, PsycINFO, and Embase. Our approach was inclusive and encompassed all empirical studies that quantified aspects of psychosocial consequences of colorectal cancer screening. We assessed the adequacy of PROM development and measurement properties for content validity using The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) risk of bias checklist.

Results: We included 33 studies that all together used 30 different outcome measures. Two PROMs (6.7%) were developed in a colorectal cancer screening context. COSMIN rating for PROM development was inadequate for 29 out of 30 PROMs (97%). PROMs lacked proper cognitive interviews and pilot studies and therefore had no proven content validity. According to the COSMIN checklist, 27 out of 30 PROMs (90%) had inadequate measurement properties for content validity.

Discussion: The majority of included PROMs had inadequate development and measurement properties. These findings shed light on the trustworthiness of the included studies' findings and call for reevaluation of existing evidence on the psychosocial consequences of colorectal cancer screening. To provide trustworthy evidence about the psychosocial consequences of colorectal cancer screening, editors could require that studies provide evidence of the methodological quality of the PROM. Alternatively, authors should transparently disclose their studies' methodological limitations in measuring psychosocial consequences of screening validly.

Purpose: Achieving and maintaining symptom control is a key treatment goal in ulcerative colitis (UC). Bowel urgency is an important symptom of UC, thus measurement of urgency is critical. This research explored the patient experience of UC and "remission" in UC, with a focus on urgency, and cognitively debriefed the Urgency Numeric Rating Scale (NRS), including score interpretation and examination of meaningful improvement.

Patients and methods: Semi-structured hybrid concept elicitation and cognitive debriefing interviews with adults with moderately-severely active UC were conducted to explore experiences of UC and urgency, as well as examine meaningful improvement and score interpretation of the Urgency NRS. Purposive sampling was used to identify 20 eligible adult participants with UC. Concept elicitation data were analyzed using thematic analysis, and a deductive approach was used to analyze cognitive debriefing data. Thematic analysis was also applied to meaningful change-related data.

Results: Twenty participants were interviewed (average age = 42.6 years old, 50% male); 14 with moderately active (70.0%) and 6 with severely active UC (30.0%). Disease remission was not consistently defined by participants and description varied in terms of definition (absence vs not complete absence of symptoms), duration (months vs days) and key symptoms to consider. Urgency was a prominent symptom for all participants, with 8 (40.0%) identifying it as the most bothersome aspect of UC. No issues were identified with the Urgency NRS. Participants were able to define different levels of urgency severity, describe how they relate to daily life impacts, and score them differently on the Urgency NRS. Participants were also able to reflect urgency improvement on the NRS and discuss how small changes in numeric ratings of urgency can reflect meaningful change in the symptom burden of their UC.

Conclusion: The Urgency NRS is a content valid and interpretable measure to assess bowel urgency severity.

Background: Prostate cancer is a disease of the prostate gland. It is a recognized tumour in men and is common worldwide. It is the second most frequent cancer and the fifth leading cause of death in males worldwide. Worldwide, prostate cancer screening continues to be a highly contested topic with a variety of differences in recommendations for screening uptake. However, for men considered to be at risk, screening continues to be the most effective method for lowering death through early identification of prostate cancer.

Objective: To determine prostate cancer screening practice and associated factors among adult men in public health facilities of Hossana Town, Ethiopia.

Methods: Facility-based cross-sectional design was used. All adult men, whose age >40 years attending public health facilities found in Hossana town were included in this study. From each public health facility, representative numbers of participants who fulfilled inclusion criteria were included in the study. A total of 422 sample sizes of adult men were used. A consecutive sampling technique was used to select study participants in each health facility. An interviewer-administered questionnaire was employed to collect data. Both descriptive and advanced analyses were performed using SPSS software version 26.0. In bivariable analysis, variables with a p-value <0.25 were considered for multivariable analysis. Finally, odds ratio with 95% CI and p-value <0.05 were used to declare factors as significantly associated with the outcome variable.

Results: About 7.2% (30) of the participants were screened for prostate cancer in this study. Ever heard about prostate cancer [AOR=26 (7.06-96.90)], family history of prostate cancer [AOR=15.5(5.18-46.77)] and awareness of anyone who has undergone prostate cancer screening [AOR= 6.8(1.95-23.64)] were identified independent predictors for prostate screening practice.

Conclusion: In this study, prostate cancer screening practice is low. Ever heard about prostate cancer, family history of prostate cancer and awareness of anyone who has undergone prostate cancer screening were independent predictors of prostate cancer screening practice. Intervention measures aiming to increase awareness about prostate cancer and prostate cancer screening should be done.

Background: Breast cancer survivors are primarily followed up to monitor the effectiveness of treatment and complications and to detect recurrences. Many breast cancer survivors may experience prolonged adverse physical and psychological effects, which should also be addressed at follow-ups. The objective of this study was to develop a brief symptom assessment tool for breast cancer survivors to be used as a guideline for the survivors and all health care professionals conducting the routine follow-up. The second objective was to describe the women's individual experiences with follow-ups.

Methods: A literature review, a focus group of 6 healthcare professionals using a nominal group technique process, and the experience and feedback via qualitative interviews with 16 breast cancer survivors was used to develop the Breast Cancer Survivors Symptom Assessment Checklist (BCS-SC).

Results: The BCS-SC consists of a set of 13 symptoms/burdens and one question. On a scale from 0 (no symptom) to 10 (worst imaginable), survivors indicated the extent to which they experience each symptom. All survivors perceived the annual follow-ups as important, but none prepared for them. Eight of the 16 survivors reported that they had 2 or more of the symptoms/burdens listed in the BCS-SC. However, only one of the survivors had mentioned her symptom to the doctor at follow-up.

Conclusion: The BCS-SC is a comprehensive assessment tool for symptoms/burdens that are common among breast cancer survivors and can aid efforts to optimize their follow-up. Furthermore, the BCS-SC allows for a more patient-initiated and focused consultation, leading to more patient-centered quality care.