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1.
Brain ; 147(8): 2842-2853, 2024 Aug 01.
Article in English | MEDLINE | ID: mdl-38662766

ABSTRACT

Amyotrophic lateral sclerosis is a devastating neurodegenerative disease, characterized by loss of central and peripheral motor neurons. Although the disease is clinically and genetically heterogeneous, axonal hyperexcitability is a commonly observed feature that has been suggested to reflect an early pathophysiological step linked to the neurodegenerative cascade. Therefore, it is important to clarify the mechanisms causing axonal hyperexcitability and how these relate to the clinical characteristics of patients. Measures derived directly from a nerve excitability recording are frequently used as study end points, although their biophysical basis is difficult to deduce. Mathematical models can aid in the interpretation but are reliable only when applied to group-averaged recordings. Consequently, model estimates of membrane properties cannot be compared with clinical characteristics or treatment effects in individual patients, posing a considerable limitation in heterogeneous diseases, such as amyotrophic lateral sclerosis. To address these challenges, we revisited nerve excitability using a new pattern analysis-based approach (principal component analysis). We evaluated disease-specific patterns of excitability changes and established their biophysical origins. Based on the observed patterns, we developed new compound measures of excitability that facilitate the implementation of this approach in clinical settings. We found that excitability changes in amyotrophic lateral sclerosis patients (n = 161, median disease duration = 11 months) were characterized by four unique patterns compared with controls (n = 50, age and sex matched). These four patterns were best explained by changes in resting membrane potential (modulated by Na+/K+ currents), slow potassium and sodium currents (modulated by their gating kinetics) and refractory properties of the nerve. Consequently, we were able to show that altered gating of slow potassium channels was associated with, and predictive of, the rate of progression of the disease on the amyotrophic lateral sclerosis functional rating scale. Based on these findings, we designed four composite measures that capture these properties to facilitate implementation outside this study. Our findings demonstrate that changes in nerve excitability in patients with amyotrophic lateral sclerosis are dominated by four distinct patterns, each with a distinct biophysical origin. Based on this new approach, we provide evidence that altered slow potassium-channel function might play a role in the rate of disease progression. The magnitudes of these patterns, quantified using a similar approach or our new composite measures, have potential as efficient measures to study membrane properties directly in amyotrophic lateral sclerosis patients, and thus aid prognostic stratification and trial design.


Subject(s)
Amyotrophic Lateral Sclerosis , Motor Neurons , Amyotrophic Lateral Sclerosis/physiopathology , Humans , Male , Female , Middle Aged , Aged , Motor Neurons/physiology , Adult , Action Potentials/physiology , Principal Component Analysis , Axons/physiology , Membrane Potentials/physiology
2.
Eur J Health Econ ; 25(6): 1071-1085, 2024 Aug.
Article in English | MEDLINE | ID: mdl-38102524

ABSTRACT

PURPOSE: The calculation of aggregated composite measures is a widely used strategy to reduce the amount of data on hospital report cards. Therefore, this study aims to elicit and compare preferences of both patients as well as referring physicians regarding publicly available hospital quality information METHODS: Based on systematic literature reviews as well as qualitative analysis, two discrete choice experiments (DCEs) were applied to elicit patients' and referring physicians' preferences. The DCEs were conducted using a fractional factorial design. Statistical data analysis was performed using multinomial logit models RESULTS: Apart from five identical attributes, one specific attribute was identified for each study group, respectively. Overall, 322 patients (mean age 68.99) and 187 referring physicians (mean age 53.60) were included. Our models displayed significant coefficients for all attributes (p < 0.001 each). Among patients, "Postoperative complication rate" (20.6%; level range of 1.164) was rated highest, followed by "Mobility at hospital discharge" (19.9%; level range of 1.127), and ''The number of cases treated" (18.5%; level range of 1.045). In contrast, referring physicians valued most the ''One-year revision surgery rate'' (30.4%; level range of 1.989), followed by "The number of cases treated" (21.0%; level range of 1.372), and "Postoperative complication rate" (17.2%; level range of 1.123) CONCLUSION: We determined considerable differences between both study groups when calculating the relative value of publicly available hospital quality information. This may have an impact when calculating aggregated composite measures based on consumer-based weighting.


Subject(s)
Choice Behavior , Patient Preference , Physicians , Humans , Middle Aged , Male , Female , Aged , Physicians/psychology , Physicians/statistics & numerical data , Adult , Hospitals , Quality Indicators, Health Care
3.
Popul Health Manag ; 26(5): 332-340, 2023 Oct.
Article in English | MEDLINE | ID: mdl-37824819

ABSTRACT

The goal of health equity is for all people to have opportunities and resources for optimal health outcomes regardless of their social identities, residence in marginalized communities, and/or experience with oppressive systems. Social determinants of health (SDOH)-the conditions in which we are born, grow, live, work, and age-are inextricably tied to health equity. Advancing health equity thus requires reliable measures of SDOH. In the United States, comprehensive individual-level data on SDOH are difficult to collect, may be inaccurate, and do not capture all dimensions of inequitable outcomes. Individual area-based indicators are widely available, but difficult to use in practice. Numerous area-level composite indices are available to describe SDOH, but there is no consensus on which indices are most appropriate to use. This article presents an analytic taxonomy of currently available SDOH composite indices and compares their components and predictive ability, providing insights into gaps and areas for further research.


Subject(s)
Health Equity , Social Determinants of Health , Humans , United States , Research
5.
Cureus ; 15(3): e36210, 2023 Mar.
Article in English | MEDLINE | ID: mdl-37065387

ABSTRACT

Background Composite measures are often used to represent certain concepts that cannot be measured with single variables and can be used as diagnoses, prognostic factors, or outcomes in clinical or health research. For example, frailty is a diagnosis confirmed based on the number of age-related symptoms and has been used to predict major health outcomes. However, undeclared assumptions and problems are prevalent among composite measures. Thus, we aim to propose a reporting guide and an appraisal tool for identifying these assumptions and problems. Methods We developed this reporting and assessment tool based on evidence and the consensus of experts pioneering research on index mining and syndrome mining. We designed a development framework for composite measures and then tested and revised it based on several composite measures commonly used in medical research, such as frailty, body mass index (BMI), mental illness diagnoses, and innovative indices mined for mortality prediction. We extracted review questions and reporting items from various issues identified by the development framework. This panel reviewed the identified issues, considered other aspects that might have been neglected in previous studies, and reached a consensus on the questions to be used by the reporting and assessment tool. Results We selected 19 questions in seven domains for reporting or critical assessment. Each domain contains review questions for authors and readers to critically evaluate the interpretability and validity of composite measures, which include candidate variable selection, variable inclusion and assumption declaration, data processing, weighting scheme, methods to aggregate information, composite measure interpretation and justification, and recommendations on the use. Conclusions For all seven domains, interpretability is central with respect to composite measures. Variable inclusion and assumptions are important clues to show the connection between composite measures and their theories. This tool can help researchers and readers understand the appropriateness of composite measures by exploring various issues. We recommend using this Critical Hierarchical Appraisal and repOrting tool for composite measureS (CHAOS) along with other critical appraisal tools to evaluate study design or risk of bias.

6.
Breast Cancer Res Treat ; 197(3): 559-568, 2023 Feb.
Article in English | MEDLINE | ID: mdl-36441271

ABSTRACT

PURPOSE: Composite measures, like textbook outcomes, may be superior to individual metrics when assessing hospital performance and quality of care. This study utilized a Delphi process to define a textbook outcome in DIEP flap breast reconstruction. METHODS: A two-round Delphi survey defined: (1) A textbook outcome, (2) Exclusion criteria for a study population, and (3) Respondent opinion regarding textbook outcomes. An a priori threshold of ≥ 70% agreement among respondents established consensus among the tested statements. RESULTS: Out of 85 invitees, 48 responded in the first round and 41 in the second. A textbook outcome was defined as one that meets the following within 90 days: (1) No intraoperative complications, (2) Operative duration ≤ 12 h for bilateral and ≤ 10 h for unilateral/stacked reconstruction, (3) No post-surgical complications requiring re-operation, (4) No surgical site infection requiring IV antibiotics, (5) No readmission, (6) No mortality, (7) No systemic complications, and (8) Length of stay < 5 days. Exclusion criteria for medical and surgical characteristics (e.g., BMI > 40, HgbA1c > 7) and case-volume cut-offs for providers (≥ 21) and institutions (≥ 44) were defined. Most agreed that textbook outcomes should be defined for complex plastic surgery procedures (75%) and utilized to gauge hospital performance for microsurgical breast reconstruction (77%). CONCLUSION: This Delphi study identified (1) Key elements of a textbook outcome for DIEP flap breast reconstruction, (2) Exclusion criteria for future studies, and (3) Characterized surgeon opinions regarding the utility of textbook outcomes in serving as quality metric for breast reconstruction care.


Subject(s)
Breast Neoplasms , Mammaplasty , Perforator Flap , Humans , Female , Mastectomy/adverse effects , Consensus , Delphi Technique , Breast Neoplasms/surgery , Breast Neoplasms/complications , Mammaplasty/adverse effects , Mammaplasty/methods , Retrospective Studies , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Treatment Outcome
7.
Mod Rheumatol ; 33(3): 588-593, 2023 Apr 13.
Article in English | MEDLINE | ID: mdl-35713223

ABSTRACT

OBJECTIVES: To investigate an optimal composite score for disease activity in adult JIA from the viewpoint of the subsequent changes in physical function. METHODS: Patients with JIA under the following conditions were enrolled: 1) disease onset < 18 years; 2) registered in the database by Tokyo Women's Medical University for the first time between 2000 and 2020; and 3) ≥18 years old at the time of registration. Patients were stratified according to mean disease activity scores in SDAI, DAS28, and JADAS-27 during the first year from baseline. Trends of estimated mean change in Japanese-HAQ score (ΔJ-HAQ) from baseline to 2 years later was examined across the stratified groups of each index. RESULTS: We included 294 eligible individuals (median age at onset, 14.0 years; RF positive in 64.7%). A significant increasing trend of the estimated mean ΔJ-HAQ at 2 years after baseline was observed along with an increase in the mean disease activity during the first year measured using DAS28 (p = 0.01) and SDAI (p = 0.018), but not using JADAS-27. CONCLUSIONS: Disease activity measured using SDAI and DAS28, but not using JADAS27, was significantly associated with subsequent changes in physical function in adult patients with JIA.


Subject(s)
Antirheumatic Agents , Arthritis, Juvenile , Humans , Adult , Female , Adolescent , Arthritis, Juvenile/drug therapy , Severity of Illness Index , Blood Sedimentation , Antirheumatic Agents/therapeutic use
8.
J Gastrointest Surg ; 26(1): 197-205, 2022 01.
Article in English | MEDLINE | ID: mdl-34327659

ABSTRACT

BACKGROUND: The composite metric textbook outcome (TO) has recently gained interest as a novel quality measure. However, the criteria for defining a TO have not been rigorously defined and patient perspectives on the characteristics of TO are unknown. METHODS: Patients who underwent major abdominal surgery at a single tertiary care center were administered a customized survey designed to ascertain their perspectives on defining TOs. The relationship between patient-reported and clinically defined TO rates was compared. RESULTS: Among 79 patients who underwent gastrointestinal (51%), pancreatic (29%), hepatic (18%), or other major abdominal (3%) operations, 57% were female and 86% had an ASA class ≥3. Most patients underwent surgery for malignancy (87%) with 60% undergoing an open operation. Patients most commonly valued no mortality following surgery (96%), no reoperation (75%), and having a margin negative resection (73%) as "extremely important." In contrast, those outcomes that were most commonly valued as "not important at all" or "minimally important" were receiving a blood transfusion (24%) and not having any complications (13%). Using previously published criteria for TOs, 47 (60%) patients were classified as having a clinically defined TO; in contrast, 68 patients (86%) self-reported their outcome was textbook. Self-reported responses were concordant with clinically defined TO criteria 63% of the time (McNemar's test: S=15.2, p<0.01, evidence of disagreement). CONCLUSION: There was significant discordance between patient-reported versus clinically defined measures of TOs, suggesting patients value other considerations beyond traditional factors when evaluating the success of their surgery. Future studies should delineate these relationships and incorporate these factors to refine TO definitions.


Subject(s)
Abdomen , Blood Transfusion , Abdomen/surgery , Female , Humans , Reoperation , Treatment Outcome
9.
Soc Sci Med ; 287: 114395, 2021 10.
Article in English | MEDLINE | ID: mdl-34530217

ABSTRACT

Community vulnerability is widely viewed as an important aspect to consider when modeling disease. Although COVID-19 does disproportionately impact vulnerable populations, human behavior as measured by community mobility is equally influential in understanding disease spread. In this research, we seek to understand which of four composite measures perform best in explaining disease spread and mortality, and we explore the extent to which mobility account for variance in the outcomes of interest. We compare two community mobility measures, three composite measures of community vulnerability, and one composite measure that combines vulnerability and human behavior to assess their relative feasibility in modeling the US COVID-19 pandemic. Extensions - via temporally dependent fixed effect coefficients - of the commonly used Bayesian spatio-temporal Poisson disease mapping models are implemented and compared in terms of goodness of fit as well as estimate precision and viability. A comparison of goodness of fit measures nearly unanimously suggests the human behavior-based models are superior. The duration at residence mobility measure indicates two unique and seemingly inverse relationships between mobility and the COVID-19 pandemic: the findings indicate decreased COVID-19 presence with decreased mobility early in the pandemic and increased COVID-19 presence with decreased mobility later in the pandemic. The early indication is likely influenced by a large presence of state-issued stay at home orders and self-quarantine, while the later indication likely emerges as a consequence of holiday gatherings in a country under limited restrictions. This study implements innovative statistical methods and furnishes results that challenge the generally accepted notion that vulnerability and deprivation are key to understanding disparities in health outcomes. We show that human behavior is equally, if not more important to understanding disease spread. We encourage researchers to build upon the work we start here and continue to explore how other behaviors influence the spread of COVID-19.


Subject(s)
COVID-19 , Pandemics , Bayes Theorem , Humans , Quarantine , SARS-CoV-2
10.
Mediterr J Rheumatol ; 32(1): 66-73, 2021 Mar.
Article in English | MEDLINE | ID: mdl-34386703

ABSTRACT

OBJECTIVES: The primary objective was to develop an educational video to teach patients with rheumatoid arthritis (RA) self-assessment of their disease activity. Secondary objectives were to validate the video, identify the challenges in producing it, and the responses to these challenges. METHODS: Rheumatologists from 7 Middle Eastern Arab countries (MEAC) discussed unmet needs in the education of patients with RA. They reviewed pre-existing educational audiovisual material and drafted the script for a new video in Arabic. The video was produced in collaboration with a technical team, then validated by patients using a standardized interview. At each step of production, challenges were identified. RESULTS: Twenty-three rheumatologists from MEAC identified unmet needs in patients' education. A video was produced, explaining the concepts of treat-to-target and showing a patient performing self-assessment using DAS-28. Sixty-two patients were interviewed for validation and found the video to be useful and easy to understand, albeit not replacing the physician's visit. Most common challenges encountered included acceptance of patient empowerment, agreement on DAS-28 as composite measure, production of a comprehensible written Arabic text, and addressing the population cultural mix. CONCLUSION: Despite challenges, the video was well accepted among patients and can be used for clinical and research purposes. It is particularly useful in pandemic periods where social distancing is recommended.

11.
Gen Hosp Psychiatry ; 72: 1-6, 2021.
Article in English | MEDLINE | ID: mdl-34174547

ABSTRACT

OBJECTIVE: Pain, anxiety, and depression (PAD) are common, co-occurring symptoms that adversely affect one another and may respond to common treatments. PAD composite measures would be useful for tracking treatment response in patients with PAD symptoms. The goal of this study is to compare 3 different PAD composite scales in terms of construct validity, responsiveness, and utility in predicting global improvement. METHOD: The sample consisted of 294 primary care patients enrolled in a telecare trial for treating pain, anxiety, and depression. Assessments at baseline and 3 months included the Brief Pain Inventory, PHQ-9 depression scale, GAD-7 anxiety scale, PROMIS measures, Medical Outcomes Study Short-Form items, disability measures, and patient-reported global improvement. Construct validity of the PAD composite measures, their responsiveness, and their ability to predict global improvement was analyzed using Pearson correlations, standardized response means, and receiver operating characteristics analysis. RESULTS: PAD composite measures correlated strongly with one another, and moderately with measures of function, vitality, and disability. Each PAD composite measure demonstrated similar responsiveness in detecting improvement at 3 months as assessed by standardized response means (SRMs) and area under the curve (AUC analyses).The SRMs for partial and substantial global improvement corresponded to moderate (Cohen's d of 0.58 to 0.69) and large (0.81 to 0.93) effect sizes, respectively. CONCLUSIONS: Three different PAD composite measures demonstrate good construct validity as well as responsiveness in detecting global improvement of pain, anxiety and depression at 3 months.


Subject(s)
Anxiety Disorders , Depression , Anxiety/diagnosis , Anxiety/therapy , Anxiety Disorders/diagnosis , Depression/diagnosis , Depression/therapy , Humans , Pain , Reproducibility of Results
12.
BMC Health Serv Res ; 21(1): 478, 2021 May 20.
Article in English | MEDLINE | ID: mdl-34016113

ABSTRACT

BACKGROUND: The quality of the discharge process and effective care transitions between settings of care are critical to minimize gaps in patient care and reduce hospital readmissions. Few studies have explored which care transition components and strategies are most valuable to patients and providers. This study describes the development, pilot testing, and psychometric analysis of surveys designed to gain providers' perspectives on current practices in delivering transitional care services. METHODS: We underwent a comprehensive process to develop items measuring unique aspects of care transitions from the perspectives of the three types of providers (downstream, ambulatory, and hospital providers). The process involved 1) an environmental scan, 2) provider interviews, 3) survey cognitive testing, 4) pilot testing, 5) a Stakeholder Advisory Group, 6) a Scientific Advisory Council, and 7) a collaborative Project ACHIEVE (Achieving Patient-Centered Care and Optimized Health in Care Transitions by Evaluating the Value of Evidence) research team. Three surveys were developed and fielded to providers affiliated with 43 hospitals participating in Project ACHIEVE. Web-based survey administration resulted in 948 provider respondents. We assessed response variability and response missingness. To evaluate the composites' psychometric properties, we examined intercorrelations of survey items, item factor loadings, model fit indices, internal consistency reliability, and intercorrelations between the composite measures and overall rating items. RESULTS: Results from psychometric analyses of the three surveys provided support for five composite measures: 1) Effort in Coordinating Patient Care, 2) Quality of Patient Information Received, 3) Organizational Support for Transitional Care, 4) Access to Community Resources, and 5) Strength of Relationships Among Community Providers. All factor loadings and reliability estimates were acceptable (loadings ≥ 0.40, α ≥ 0.70), and the fit indices showed a good model fit. All composite measures positively and significantly correlated with the overall ratings (0.13 ≤ r ≤ 0.71). CONCLUSIONS: We determined that the items and composite measures assessing the barriers and facilitators to care transitions within this survey are reliable and demonstrate satisfactory psychometric properties. The instruments may be useful to healthcare organizations and researchers to assess the quality of care transitions and target areas of improvement across different provider settings.


Subject(s)
Patient Transfer , Patient-Centered Care , Humans , Psychometrics , Reproducibility of Results , Surveys and Questionnaires
13.
BMC Pulm Med ; 21(1): 159, 2021 May 12.
Article in English | MEDLINE | ID: mdl-33980194

ABSTRACT

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is a heterogeneous disease with a complex progression of many clinical presentations, and clinically important deterioration (CID) has been proposed in the Western studies as a composite endpoint of disease progression. The aim of this study was to investigate the relationships between 1-year CID and the following long-term clinical outcomes in Japanese patients with COPD who have been reported to have different characteristics compared to the Westerners. METHODS: Among Japanese patients with COPD enrolled in the Hokkaido COPD cohort study, 259 patients who did not drop out within the first year were analyzed in this study. Two definitions of CID were used. Definition 1 comprised ≥ 100 mL decrease in forced expiratory volume in 1 s (FEV1), ≥ 4-unit increase in St George's Respiratory Questionnaire (SGRQ) score from baseline, or moderate or severe exacerbation. For Definition 2, the thresholds for the FEV1 and SGRQ score components were doubled. The presence of CID was evaluated within the first year from enrollment, and analyzed the association of the presence of CID with following 4-year risk of exacerbations and 9-year mortality. RESULTS: Patients with CID using Definition 1, but not any single CID component, during the first year had a significantly worse mortality compared with those without CID. Patients with CID using Definition 2 showed a similar trend on mortality, and had a shorter exacerbation-free survival compared with those without CID. CONCLUSIONS: Adoption of CID is a beneficial and useful way for the assessment of long-term disease progression and clinical outcomes even in Japanese population with COPD. The definition of CID might be optimized according to the characteristics of COPD population and the observation period for CID.


Subject(s)
Bronchodilator Agents/administration & dosage , Forced Expiratory Volume/physiology , Pulmonary Disease, Chronic Obstructive/diagnosis , Pulmonary Disease, Chronic Obstructive/physiopathology , Aged , Clinical Deterioration , Cohort Studies , Disease Progression , Female , Forced Expiratory Volume/drug effects , Humans , Japan , Male , Middle Aged , Pulmonary Disease, Chronic Obstructive/drug therapy , Surveys and Questionnaires , Time Factors , Treatment Outcome
14.
Best Pract Res Clin Rheumatol ; 35(2): 101669, 2021 06.
Article in English | MEDLINE | ID: mdl-33839045

ABSTRACT

There have been considerable advances in the classification and assessment of psoriatic arthritis (PsA). In this report, we give an overview of historic and current classification criteria and discuss its role and limitations in research and clinical practice. We discuss the most commonly used assessment instruments for arthritis, psoriasis, onychodystrophy, enthesitis, dactylitis and axial PsA with a focus on clinical practice. We pay particular attention to the current evidence for the use of composite outcome measures, and their use in randomised controlled trials and routine care.


Subject(s)
Arthritis, Psoriatic , Psoriasis , Arthritis, Psoriatic/diagnosis , Humans , Outcome Assessment, Health Care
15.
J Rheumatol ; 48(8): 1272-1278, 2021 08.
Article in English | MEDLINE | ID: mdl-33722944

ABSTRACT

OBJECTIVE: To identify (1) which composite measure is the most stringent target of remission; and (2) which disease component target proves the most difficult to achieve in the different states of minimal disease activity (MDA), Composite Psoriatic Disease Activity Index (CPDAI), Disease Activity Index for Psoriatic Arthritis (DAPSA), and clinical DAPSA (cDAPSA) in patients with psoriatic arthritis (PsA). METHODS: There were 258 patients with PsA recruited. Disease remission was evaluated comparing 4 different composite measures and using remission cutoffs as previously proposed (very low disease activity [VLDA], CPDAI ≤ 2, DAPSA ≤ 4, cDAPSA ≤ 4). RESULTS: Patients met VLDA criteria (MDA 7/7) in 9.0% of visits, DAPSA remission in 19.8%, cDAPSA remission in 23.4% and CPDAI remission in 30.2%. Of 258 patients, MDA criteria (≥ 5/7) were fulfilled in 46.5%. Of those in MDA, VLDA criteria were reached in 25.0%. Patients met the pain visual analog scale (VAS) target in 57.5% of visits when they were in MDA, 43.3% when in low disease activity (MDA 5-6/7), and 44.8% when in CPDAI remission. Multivariate regression analysis revealed that pain VAS was the least likely target to be achieved. Patients with inflammatory-type back pain had significantly higher pain scores; further, a significant relationship was seen between Bath Ankylosing Spondylitis Disease Activity Index and pain VAS. CONCLUSION: Based on our analysis, VLDA proved the most stringent target of disease remission in PsA compared to CPDAI, DAPSA, and cDAPSA. The pain VAS target of ≤ 1.5 cm was the most difficult component to achieve. CPDAI ≤ 2 was found to be the least stringent remission target; however, measurements of axial involvement, which contributed to the elevated pain VAS score in patients not achieving VLDA, were included as a domain in CPDAI only.


Subject(s)
Antirheumatic Agents , Arthritis, Psoriatic , Antirheumatic Agents/therapeutic use , Arthritis, Psoriatic/diagnosis , Arthritis, Psoriatic/drug therapy , Humans , Remission Induction , Severity of Illness Index , Treatment Outcome
16.
Rheumatology (Oxford) ; 60(3): 1137-1147, 2021 03 02.
Article in English | MEDLINE | ID: mdl-32864685

ABSTRACT

OBJECTIVES: To examine which composite measures are most sensitive to change when measuring psoriatic arthritis (PsA) disease activity, analyses compared the responsiveness of composite measures used in a 48-week randomized, controlled trial of MTX and etanercept in patients with PsA. METHODS: The trial randomised 851 patients to receive weekly: MTX (20 mg/week), etanercept (50 mg/week) or MTX plus etanercept. Dichotomous composite measures examined included ACR 20/50/70 responses, minimal disease activity (MDA) and very low disease activity (VLDA). Continuous composite measures examined included Disease Activity Score (28 joints) using CRP (DAS28-CRP), Clinical Disease Activity Index (CDAI), Simplified Disease Activity Index (SDAI), Disease Activity for Psoriatic Arthritis (DAPSA) and Psoriatic Arthritis Disease Activity Score (PASDAS). RESULTS: At week 24, etanercept-treated groups were significantly more effective than MTX monotherapy to achieve ACR 20 (primary end point) and MDA (key secondary end point). When examining score changes from baseline at week 24 across the five continuous composite measures, PASDAS demonstrated relatively greater changes in the etanercept-treated groups compared with MTX monotherapy and had the largest effect size and standardized response. Joint count changes drove overall score changes at week 24 from baseline in all the continuous composite measures except for PASDAS, which was driven by the Physician and Patient Global Assessments. CONCLUSION: PASDAS was the most sensitive continuous composite measure examined with results that mirrored the protocol-defined primary and key secondary outcomes. Composite measures with multiple domains, such as PASDAS, may better quantify change in PsA disease burden. TRAIL REGISTRATION: https://ClinicalTrials.gov, number NCT02376790.


Subject(s)
Antirheumatic Agents/therapeutic use , Arthritis, Psoriatic/drug therapy , Etanercept/therapeutic use , Methotrexate/therapeutic use , Patient Outcome Assessment , Administration, Oral , C-Reactive Protein/analysis , Double-Blind Method , Drug Therapy, Combination , Female , Humans , Injections, Subcutaneous , Male , Middle Aged , Severity of Illness Index
17.
Int J Qual Health Care ; 33(1)2021 Feb 20.
Article in English | MEDLINE | ID: mdl-33201215

ABSTRACT

OBJECTIVES: To highlight clinical and operational issues, identify factors that shape patient responses in Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) and test the correlations between composite measures and overall hospital ratings. DESIGN: Responses to HCAHPS surveys were used in a partial correlation analysis to ascertain those HCAHPS composite measures that most relate to overall hospital ratings. The linear mean scores for the composite measures and individual and global items were analyzed with descriptive analysis and correlation analysis via JMP and SPSS statistical software. SETTING: HCAHPS is a patient satisfaction survey required by the Centers for Medicare and Medicaid Services for hospitals in the USA. The survey is for adult inpatients, excluding psychiatric patients. PARTICIPANTS: 3382 US hospitals. INTERVENTION: None. MAIN OUTCOME MEASURE: Pearson correlation coefficients for the six composite measures and overall hospital rating. RESULTS: The partial correlations for overall hospital rating and three composite measures are positive and moderately strong for care transition (0.445) and nurse communication (0.369) and weak for doctor communication (0.066). CONCLUSIONS: From a health policy standpoint, it is imperative that hospital administrators stress open and clear communication between providers and patients to avoid problems ranging from misdiagnosis to incorrect treatment. Additional research is needed to determine how the coronavirus of 2019 pandemic influences patients' perceptions of quality and willingness to recommend hospitals at a time when nurses and physicians show symptoms of burnout due to heavy workloads and inadequate personal protective equipment.


Subject(s)
COVID-19/epidemiology , Hospitals/standards , Patient Satisfaction , Professional-Patient Relations , Quality Indicators, Health Care , Humans , SARS-CoV-2 , Surveys and Questionnaires , United States/epidemiology
18.
J Rheumatol Suppl ; 96: 11-18, 2020 Jun.
Article in English | MEDLINE | ID: mdl-32482762

ABSTRACT

OBJECTIVE: Improving the assessment of psoriatic arthritis (PsA) is a key purpose of the Group for Research and Assessment of Psoriasis and PsA (GRAPPA). Herein, we report the proceedings of the GRAPPA composites workshop at the 2019 GRAPPA annual meeting and the membership's recommended next steps. METHODS: A review of continuous composite measures was conducted in an introductory workshop, followed by 10 breakout group sessions and a final plenary session for feedback and voting. RESULTS: Participants included 154 members: 87 rheumatologists, 18 dermatologists, 2 rheumatologist/dermatologists, 12 patient research partners, 14 academics, 1 methodologist, and 20 industry members. Of voting members, 88.8% agreed a need exists for a continuous composite measure for routine practice, but only 62% were currently using a composite measure. Of these, 27% were using the 28-joint count Disease Activity Score (DAS), which is not a PsA-specific measure; 20% were using a PsA-specific measure such as PsA DAS (PASDAS), Composite Psoriatic Disease Activity Index (CPDAI), or Disease Activity Index for PsA (DAPSA). Members agreed that the existing measures were not feasible in their current forms (CPDAI 83%, PASDAS 82%, and DAPSA 47%) and that modification should be tested. The majority (76%) agreed that disease effect should be measured separately from disease activity. CONCLUSION: The GRAPPA membership supports the need for a continuous composite measure of disease activity for use in routine clinical care, the separate measurement of disease effect and activity, and the testing of modifications to candidate instruments rather than the development of new measures.


Subject(s)
Arthritis, Psoriatic , Psoriasis , Arthritis, Psoriatic/diagnosis , Arthritis, Psoriatic/therapy , Dermatology , Humans , Psoriasis/diagnosis , Psoriasis/therapy , Rheumatology
19.
Health Qual Life Outcomes ; 18(1): 192, 2020 Jun 19.
Article in English | MEDLINE | ID: mdl-32560725

ABSTRACT

BACKGROUND: Recent trends on measurement of well-being have elevated the scientific standards and rigor associated with approaches for national and international comparisons of well-being. One major theme in this has been the shift toward multidimensional approaches over reliance on traditional metrics such as single measures (e.g. happiness, life satisfaction) or economic proxies (e.g. GDP). METHODS: To produce a cohesive, multidimensional measure of well-being useful for providing meaningful insights for policy, we use data from 2006 and 2012 from the European Social Survey (ESS) to analyze well-being for 21 countries, involving approximately 40,000 individuals for each year. We refer collectively to the items used in the survey as multidimensional psychological well-being (MPWB). RESULTS: The ten dimensions assessed are used to compute a single value standardized to the population, which supports broad assessment and comparison. It also increases the possibility of exploring individual dimensions of well-being useful for targeting interventions. Insights demonstrate what may be masked when limiting to single dimensions, which can create a failure to identify levers for policy interventions. CONCLUSIONS: We conclude that both the composite score and individual dimensions from this approach constitute valuable levels of analyses for exploring appropriate policies to protect and improve well-being.


Subject(s)
Cultural Characteristics , Happiness , Personal Satisfaction , Quality of Life/psychology , Adult , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Surveys and Questionnaires
20.
Rheumatology (Oxford) ; 59(Suppl 1): i29-i36, 2020 03 01.
Article in English | MEDLINE | ID: mdl-32159792

ABSTRACT

PsA is a complex, heterogeneous disease that can place a large burden on patients' psychological and physical well-being. The multifaceted nature of PsA poses a significant assessment challenge, both in randomized control trials and in clinical practice. In recent years, there has been much progress in the development of unidimensional and composite measures of disease activity, as well as of questionnaires that capture the patient's perspective of the condition. Despite these advances, there remains uncertainty around which tools to implement within a research setting. This review aims to summarize the currently available clinical and patient-derived assessment tools, providing a practical and informative resource for the assessment of PsA. This review will also explore recent advancements in digital approaches to the assessment of rheumatological conditions. This will highlight the potential for digitalization in the assessment and monitoring of PsA, outlining innovative means of capturing disease activity and treatment response.


Subject(s)
Arthritis, Psoriatic/drug therapy , Arthritis, Psoriatic/psychology , Medical Informatics/instrumentation , Surveys and Questionnaires/statistics & numerical data , Arthritis/complications , Arthritis, Psoriatic/pathology , Cost of Illness , Enthesopathy/complications , Humans , Outcome Assessment, Health Care , Pain Measurement/statistics & numerical data , Quality of Life , Randomized Controlled Trials as Topic , Spondylarthropathies/complications , Telemedicine/methods
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