Background: As one of the main goals of hip and knee replacements is to improve patients' health-related quality of life, a meaningful evaluation can be achieved by calculating minimal important changes (MICs) for improvements in patient-reported outcome measures (PROMs). This study aims at providing MICs adjusted for patient characteristics for EQ-5D-3L index score improvements after hip and knee replacements. It adds to existing literature by relying on a large national sample and precise clustering algorithms, and by employing a state-of-the-art methodology for the calculation of improved adjusted MICs.
Methodology: A retrospective observational study was conducted using the publicly available National Health Service (NHS) PROMs dataset for primary hip and knee replacements. We used information on 252,331 hip replacements and 279,668 knee replacements from all NHS-funded providers in England between 2013 and 2020. Clusters of patients were created based on pre-operative EQ-VAS, depression status, and sex. Unstratified and stratified estimates for meaningful EQ-5D-3L improvements were obtained through anchor-based predictive MICs corrected for the proportion of improved patients and the reliability of transition ratings.
Results: Stratifying patients showed that MICs varied across subgroups based on pre-operative EQ-VAS, depression status, and sex. MICs were larger for patients with worse pre-operative EQ-VAS scores, while patients with better pre-operative scores required smaller MICs to achieve a meaningful change. We show how after stratification the percentage of patients achieving their stratified MIC was better in line with the actual share of improved patients. Larger MICs were found for patients with depression and for female patients. MICs calculated for knee replacements were consistently lower than those for hip replacements.
Conclusions: Our findings show the importance of adjusting MICs for patients' characteristics and should be considered for quality-related choices and policy initiatives.
Background: This study examines the impact of SARS-CoV-2 (i.e., coronavirus, COVID, COVID-19) using data from a measurement-based care (MBC) system utilized in an outpatient psychiatric clinic providing telemedicine care. A novel Patient Rated Outcome Measure (PROM), the COVID-19 Events Checklist (CEC) was administered in a hospital system based ambulatory clinic beginning April 2020 to track COVID-19-19's impact on patients' mental, emotional, and health-related behaviors during the pandemic. The study (1) provides descriptive CEC data, and (2) compares CEC results with PROMs evaluating anxiety (Generalized Anxiety Disorder-7; GAD-7), depression (Patient Health Questionnaire; PHQ-9), and psychological distress (Brief Adjustment Scale-6; BASE-6).
Methods: This retrospective observational study included patient intake data collected from April 2020 to March 2021. Patient (N = 842) reports on the CEC's five domain questions were aggregated to calculate average reports of COVID-19 related impacts at intake over the initial 12 months of the pandemic. Trends in COVID-19 related impacts were examined, and non-aggregated scores on the PHQ-9, GAD-7, and BASE-6 were compared to primary dichotomous (yes/no) CEC survey questions via Wilcoxon rand sum testing.
Results: Results capture the relationship between COVID-19 exposure, COVID-19- related sequelae and behaviors, and psychological symptom severity. Specifically, Wilcoxon rank-sum tests indicate that social determinants of health (SDOH), negative mental health impacts, and positive coping skill use were significantly associated with psychological symptomatology including overall psychological functioning via the BASE-6, anxiety via the GAD-7, and depressive symptoms via the PHQ-9. Results regarding SDOH were as follows: BASE-6 (w = 44,005, p < 0.001), GAD-7 (w = 44,116, p < 0.001), and PHQ-9 (w = 43,299, p < 0.001). Regarding negative mental health outcomes, the results were: BASE-6 (w = 38,374, p < 0.001), GAD-7 (w = 39,511, p < 0.001), and PHQ-9 (w = 40,154, p < 0.001). As the initial year of the pandemic elapsed, incoming patients demonstrated increased rates of suspected or confirmed exposure to COVID-19, (+2.29%, t = 3.19, p = 0.01), reported fewer negative impacts of COVID-19 on SDOH (-3.53%, t= -2.45, p = 0.034), and less engagement in positive coping strategies (-1.47%, t = -3.14, p = 0.010).
Conclusions: Psychosocial factors related to COVID-19 are discussed, as well as opportunities for further research on the relationship between psychological symptomatology and the impact of COVID-19 on health-related behaviors.
Background: To meaningfully understand outcomes of gender-affirming care, patient-reported outcome measures (PROMs) that are grounded in what matters to individuals seeking care are urgently needed. The objective of this study was to develop a comprehensive PROM to assess outcomes of gender-affirming care in clinical practice, research, and quality initiatives (the GENDER-Q).
Methods: Internationally established guidelines for PROM development were used to create a field test version of the GENDER-Q. In-depth interviews were conducted from December 2018 to March 2020 with youth and adults aged 16 years and older who were seeking or had received gender-affirming care at outpatient clinics providing gender-affirming care located within tertiary care centers or communities in Canada, Denmark, the Netherlands or the US. Data were analyzed and used to develop a conceptual framework and an item pool, which was used to develop preliminary scales. Between February 2021 to November 2021, iterative feedback was sought from clinicians and patient participants on the scales and used to refine or develop new scales. The revised scales were pilot-tested using a crowd-sourcing platform between February 2022 and April 2022.
Results: Data from interviews with 84 participants (aged 34 ± 14 years) resulted in a conceptual framework of the GENDER-Q with 13 domains measuring health-related quality of life, sexual, urination, gender practices, voice, hair, face and neck, body, breasts, genital feminization, chest, genital masculinization, and experience of care. Preliminary versions of 44 scales were developed covering most concepts in the conceptual framework. Iterative feedback was obtained from clinician experts (4 to 37 experts per scale; response rate, 67%) and 7-14 patient participants (depending on scale). All scales were refined, and 15 new scales were developed, resulting in 55 scales in the field test version of the GENDER-Q. In total, 601 transgender and gender diverse (TGD) people (aged 25 ± 6 years) participated in the pilot field test and the data were used to make changes to the field test survey.
Conclusion: The GENDER-Q was developed using extensive input from TGD individuals and clinician experts and represents the most comprehensive set of independently functioning scales that are available to date. An international field test of the GENDER-Q was completed in 2024 and the GENDER-Q is available for use in patient care, clinical research and quality improvement efforts.
Background: Patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) are becoming essential parts of a learning health system, and using these measures is a promising approach for value-based healthcare. However, evidence regarding healthcare professional and patient organizations' knowledge, use and perception of PROMs and PREMs is lacking.
Objectives: The objectives of the study were to: 1- Describe the current knowledge and use of PROMs and PREMs by healthcare professional and patient organizations, 2- Describe the determinants of PROMs and PREMs implementation according to healthcare professional and patient organizations.
Methods: We conducted an environmental scan using semi-structured interviews with representatives from healthcare professional and patient organizations. Interviews were recorded and live coded based on the Franklin framework. We used inductive and deductive thematic analysis to extract information about the main themes addressed during the interview (awareness of PROMs and PREMs, examples of implementation and use of PROMs and PREMs, tools used, vision for future implementation, barriers and facilitators to implementation and the best way to collect PROMs and PREMs data).
Results: 63% of healthcare professional organizations (n = 19) and 41% of patient organizations (n = 9) that were contacted agreed to have a representative interviewed. The representatives from both the healthcare professional and patient organizations acknowledged the importance of assessing patients' experience and outcomes. However, they considered the implementation of PROMs and PREMs tools to be scarce within their organizations, in clinical practice and in the education system. Patient organizations were worried that overuse of PROMs and PREMs could lead to depersonalization of practice. Barriers to implementing PROMs and PREMs included lack of awareness of tools, resistance to change and lack of motivation to complete or explain the questionnaire. Barriers also included factors such as lack of financial, technological and human resources and issues with integration of data and inconsistency of digital platforms.
Conclusions: This environmental scan revealed a lack of awareness of tools by healthcare professional and patient organizations' representatives and limited implementation. Adequate training, technological integration, and demonstration of PROMs and PREMs benefits to foster broader adoption in clinical and organizational settings is dearly needed. Addressing these challenges is essential for enhancing value-based care.
Background: Late-onset Pompe disease (LOPD), a rare autosomal recessive multisystemic disorder, substantially impacts patients' day-to-day activities, outcomes, and health-related quality of life (HRQoL). The PROPEL trial compared cipaglucosidase alfa plus miglustat (cipa+mig) with alglucosidase alfa plus placebo (alg+pbo) in adult patients with LOPD over 52 weeks and showed improved motor and respiratory function in patients switching treatment from standard-of-care enzyme replacement therapy (ERT) to cipa+mig at baseline. This study evaluated the impact of cipa+mig on patient-reported outcomes (PROs), including HRQoL in ERT-experienced patients, using data from PROPEL.
Methods: PROs evaluated included the Subject's Global Impression of Change (SGIC), Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 20a, PROMIS Fatigue Short Form 8a, Rasch-built Pompe-specific Activity (R-PAct), and European Quality of Life-5 Dimensions 5 Response Levels (EQ-5D-5L). The proportions of responders in the cipa+mig arm and the alg+pbo arm were compared via chi-squared or Fisher's exact test (patient-level responder analysis), and least squares (LS) mean differences were calculated for change from baseline at Week 52 of the PRO measures (group-level analysis).
Results: At Week 52, patient-level SGIC responder and group-level SGIC analyses favored cipa+mig compared with alg+pbo across all SGIC domains (e.g. 90 vs. 59% responders in the cipa+mig vs. the alg+pbo group for SGIC ability to move around; P = 0.0005; and LS mean difference 0.385; P = 0.02). Similarly, PROMIS Physical Function and Fatigue domains numerically favored cipa+mig in both analyses (e.g. 50 vs. 40% responders in the cipa+mig vs. alg+pbo arm for PROMIS Physical Function; P = 0.37; and LS mean difference 3.1; P = 0.11). R-PAct for both treatment groups was similar in the patient-level responder analysis, but numerically favored alg+pbo in the group-level analysis (35% responders in both arms; P = 0.95; and LS mean difference -0.8; P = 0.48). Self-care, usual activities, and depression/anxiety domains of EQ-5D-5L numerically favored cipa+mig in both analyses (e.g. 20 vs. 12% responders in the cipa+mig vs. alg+pbo arm for EQ-5D-5L self-care; P = 0.54; and LS mean difference -0.108; P = 0.52).
Conclusions: Overall, switching treatment from alglucosidase alfa to cipa+mig positively impacted PRO measurements during the double-blind period of PROPEL.
Trial registration: NCT03729362; Registration date: November 1, 2018; https://clinicaltrials.gov/study/NCT03729362.
Background: Bowel urgency, the sudden and immediate need to have a bowel movement, is common in patients with ulcerative colitis (UC) and Crohn's disease (CD). While its impact in UC is well established, less is known about its importance in CD. Further, what level of bowel urgency control patients with UC or CD would consider to be acceptable or in remission has not been established. This qualitative study aimed to understand perceptions of bowel urgency and remission in these patients.
Methods: Semi-structured combined concept elicitation and cognitive interviews were conducted to explore how adults with moderate-to-severe UC or CD and current or recent bowel urgency think about the concept of bowel urgency and its remission. The Urgency Numeric Rating Scale (UNRS) was used to examine different levels of bowel urgency severity and to investigate what level of bowel urgency patients would consider as representing remission.
Results: Forty adults (n = 19 UC, n = 21 CD) recruited from six US sites completed the study. Sociodemographic and clinical characteristics were similar in both groups. Both groups reported impacts of bowel urgency on physical, social, professional, and emotional aspects of their lives. Most participants (n = 15 UC, n = 18 CD) reported having experienced one or more incidents of urgency-related fecal incontinence. Most participants considered remission to be a state with a normal or reduced number of bowel movements and no or less frequent bowel urgency, and they noted that remission would increase their ability to engage in daily activities without fear of fecal incontinence. Participants were able to map different levels of severity of bowel urgency to UNRS score ranges (scale: 0-10), and they indicated that a mean UNRS score of 5 (UC) or 4 (CD) would be the highest point on the NRS at which they would still consider their bowel urgency to be in remission.
Conclusions: Bowel urgency is an important issue for patients with either moderate-to-severe UC or CD, and its remission would improve their lives. Further, these patients may still consider bowel urgency to be in remission even at UNRS scores as high as 4 or 5.
Introduction: For advanced osteoarthritis of the knee and hip, the most clinically effective treatment remains total-knee arthroplasty (TKA) and total-hip arthroplasty (THA). Success of these surgeries have traditionally been appraised by economic and volume-based measures. There has been a shift towards the use of patient reported outcome measures (PROMs) to quantify success and guide treatment. The present study provides analysis of three PROMS which have been validated for use in orthopaedic settings; the Oxford Knee Score (OKS), Oxford Hip Score (OHS), Forgotten Joint Score (FJS), and the EuroQol-Visual Analogue Scale (EQ-VAS) - a non-disease specific measure of health. PROMs were completed pre-operatively, 6-weeks, and 1-year after elective TKA and THA undertaken in 2018 in a public teaching hospital in South Australia. Post-operative satisfaction/dissatisfaction was measured using a 5-point Likert scale and was collected at the same 6-week and 1-year points.
Results: PROMs were collected from 285 eligible elective knee-arthroplasty, and 205 elective hip-arthroplasty patients. There was significant average improvement, greater than minimal clinical important differences between pre-operative and 1-year post-operative scores for all three PROMs tools. Inter-PROM correlation was strongest between FJS and OKS at 1-year post TKA (rs = 0.722), and between FJS and OHS in post-THA at the same interval (rs = 0.609). TKA patients with higher pre-surgical 10-year mortality were weakly associated with lower pre-operative OKS score (rs = 0.169). BMI was weakly negatively associated with pre-operative and 6-week post-operative EQ-VAS scores (rs = -0.291 and rs = -0.149 respectively). Post-TKA satisfaction was 77.2% at 1-year, and THA 88.5% at the same interval.
Conclusion: This study provides an early insight from the use of the OKS, OHS, the EQ-VAS and the FJS as PROMs in primary TKA and THA at our centre. All PROMs demonstrate significant increase (improvement) at both 6-week and 1-year post-operative intervals, relative to pre-operative scores. The FJS demonstrated good sensitivity. Pre-existing co-morbidities do not appear to have any significant relation with post-operative PROMs collected in this study.
Background: Degenerative Cervical Myelopathy is a debilitating condition and current recommendations encourage shared decision-making between surgeons and patients. However, there is limited data on patients' values and preferences for surgical decision making. This study aimed to quantify and compare the relative importance of neurologic function, risk of future surgery, and complications to patients with cervical stenosis.
Methods: Patients with cervical stenosis presenting for surgical evaluation, or post-operative cervical decompression patients, were recruited to participate. Demographic information including modified Japanese Orthopedic Association (mJOA) score, type of surgery, and complications were recorded and anonymized to study ID. Patients then completed an online discrete-choice experiment survey. In a series of 10 questions, respondents chose between two hypothetical health states defined in terms of five attributes, or "decision factors": (i) upper extremity neurologic function, (ii) lower extremity neurologic function, (iii) risk of cervical spine surgery, (iv) dysphagia, and (v) C5 palsy. Participants were asked to choose which 'life' they preferred, and a regression model was used to quantify the importance of each decision factor.
Results: We report three key findings that can aid clinicians in shared decision-making conversations: (i) all patients regard lower extremity neurologic function as the most important decision factor, (ii) dysphagia, a complication, and upper extremity neurologic function are equally important, and (iii) patients who have undergone surgery weigh neurologic function as less important, and complications as more important than patients who have not undergone surgery.
Conclusions: Patient preferences for management of degenerative cervical myelopathy are influenced by several considerations including the experience of surgery itself. Communication of benefits and harms associated with surgical and conservative care can optimize shared decision making. Further research should be conducted to evaluate for decisional regret and the impact of complications to inform treatment conversations.
Background: Health systems need tools to assess patient's experience of service, but existing tools lack reliability and validity assessment. Our aim is to investigate the factor structure, reliability, validity, item parameters and interpretability of the parent version of the Experience of Service Questionnaire (ESQ) for practical use in Greece.
Methods: A total of 265 caregivers that were using mental health services in Greece participated in this study as part of the Nationwide cross-sectional survey from the Child and Adolescent Mental Health Initiative (CAMHI). Confirmatory Factor Analysis was used to test factor structure. Reliability of all models were measured with omega coefficients. Tobit regression analysis was used to test for convergent and discriminant validity with specifically designed questions. Item parameters were assessed via Item Response Theory. Interpretability was assessed by means of IRT-based scores.
Results: We found that ESQ is best represented and scored as a unidimensional construct, given potential subscales would not have enough reliability apart from a general factor. Convergent and discriminant validity was demonstrated, as caregivers who perceived that their child benefited from the received mental health care had 6.50 higher summed scores (SMD = 1.14, p < 0.001); while those who believed that their child needed additional help had 5.08 lower summed scores on the ESQ (SMD = -0.89, p < 0.001). Average z-scores provided five meaningful categories of services, in terms of user satisfaction, compared to the national average.
Conclusions: Our study presents evidence for the reliability and validity of the ESQ and provides recommendations for its practical use in Greece. ESQ can be used to measure experience of service and might help drive improvements in service delivery in the Greek mental health sector.
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