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Value in Health : the Journal of the... Jul 2023
Topics: Humans; Outcome Assessment, Health Care; Advisory Committees
PubMed: 37182821
DOI: 10.1016/j.jval.2023.04.011 -
The Journal of Evidence-based Dental... Jan 2024Dental patient-centered outcomes can improve the relevance of clinical study results to dental patients and generate evidence to optimize health outcomes for dental...
Dental patient-centered outcomes can improve the relevance of clinical study results to dental patients and generate evidence to optimize health outcomes for dental patients. Dental patient-reported outcomes (dPROs) are of great importance to patient-centered dental care. They can be used to evaluate the health outcomes of an individual patient about the impact of oral diseases and treatment, and to assess the quality of oral health care delivery for a health care entity. dPROs are measured with dental patient-reported outcome measures (dPROMs). dPROMs should be validated and tested before wider dissemination and application to ensure that they can accurately capture the intended dPROs. Evidence suggests inadequate dPRO usage among dental trials, as well as potential flaws in some existing dPROMs. This Glossary presents a collection of main terms in dental patient-centered outcomes to help clinicians and researchers read and understand patient-centered clinical studies in dentistry.
Topics: Humans; Outcome Assessment, Health Care; Patient Reported Outcome Measures; Patient-Centered Care; Health Facilities; Quality of Life
PubMed: 38401954
DOI: 10.1016/j.jebdp.2023.101951 -
European Urology Oct 2023In the oncology setting, patient-reported outcome measures (PROMs) provide important data that help to ensure patient-relevant endpoints are captured and reported. Use... (Review)
Review
CONTEXT
In the oncology setting, patient-reported outcome measures (PROMs) provide important data that help to ensure patient-relevant endpoints are captured and reported. Use of this information for treatment decision-making by clinicians and patients in real-world settings is facilitated by consistent and transparent reporting of trial methods.
OBJECTIVE
To identify and compare PROMs used in advanced renal cell carcinoma (RCC) trials in terms of the rationale for the choice of measure, endpoint hierarchy (primary, secondary, exploratory), assessment time points, statistical methods, and statistical metrics for interpretation.
EVIDENCE ACQUISITION
A systematic literature review via searches of four online databases (2016-2021) and recent conference abstracts (2019-2021) identified 2616 articles, of which 33 were included in the review according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.
EVIDENCE SYNTHESIS
Among the 33 clinical studies included, 19 different PROMs were identified: three kidney cancer-specific scales, two cancer-specific scales, two generic scales, and 12 symptom-specific scales. The endpoint hierarchy for patient reported outcome (PRO) assessment was reported in 42% of the studies; one study included PROs as a primary endpoint. Reporting of time points, minimal important differences, and statistical analyses was highly heterogeneous.
CONCLUSIONS
A diverse range of PROMs have been included in clinical studies for patients with advanced/metastatic RCC. Prespecified analyses for PRO assessments were generally not stated, while analytical methods and reporting varied. An improvement in alignment across studies would better inform regulatory, market-access, reimbursement, and clinical decision-making to improve patient care.
PATIENT SUMMARY
We reviewed how the impact of cancer therapies on health outcomes from the patient's point of view is being measured in clinical trials for kidney cancer. The techniques and reporting varied across trials. Standardisation of how these data are captured and reported may improve care and decision-making for patients with kidney cancer.
Topics: Humans; Carcinoma, Renal Cell; Patient Reported Outcome Measures; Kidney Neoplasms; Patient Outcome Assessment; Research Design
PubMed: 37550153
DOI: 10.1016/j.eururo.2023.07.006 -
Clinics in Chest Medicine Sep 2023Expansion of telehealth services has the potential to attenuate health inequities in pulmonary medicine, by improving access to care and health outcomes in patients with... (Review)
Review
Expansion of telehealth services has the potential to attenuate health inequities in pulmonary medicine, by improving access to care and health outcomes in patients with lung disease. These telehealth services include remote patient monitoring, synchronous telemedicine, and remote pulmonary rehabilitation. Currently, patients who are White, well-educated, wealthy, and from urban areas are the most likely to benefit from telehealth services. Without clear policy decisions and planning to overcome the "Digital Divide," telehealth services will only exacerbate existing disparities within the pulmonary disease. We describe the benefits and limitations of these new technologies and their impact on improving equity in pulmonary medicine.
Topics: Humans; Telemedicine; Pulmonary Medicine; Outcome Assessment, Health Care; Health Services Accessibility
PubMed: 37517842
DOI: 10.1016/j.ccm.2023.03.017 -
Value in Health : the Journal of the... Sep 2023Widespread use of electronic health records (EHRs) now makes it feasible to expand beyond health insurance claims data to include full EHR data for health economics and...
OBJECTIVES
Widespread use of electronic health records (EHRs) now makes it feasible to expand beyond health insurance claims data to include full EHR data for health economics and outcomes research (HEOR) studies. We seek to develop ways to maximize researcher access to such data while strongly protecting patients' privacy rights.
METHODS
We analyzed alternative organizational structures and intellectual property rights assignments as they now exist and compared these with structures and intellectual property rights assignments that would maximize access to data for HEOR studies and minimize transactions costs. We analyzed data protection requirements and financial incentives at 3 levels: patient decision making, patients' data aggregators, and final aggregation across patients' data.
RESULTS
Creating new HEOR data systems requires new organizations and funding, while also protecting patients' data privacy rights. The Cures Act enables a new market for trusted third parties (TTPs) to aggregate patients' data. New secondary data aggregators must combine individuals' aggregated EHRs into usable HEOR databases. Maximal patient participation requires complete health insurance coverage of costs that healthcare providers charge for transmitting patients' data to TTPs. The new secondary system to aggregate data from many TTPs into usable HEOR optimally has external funding.
CONCLUSIONS
Important steps remain uncompleted to achieve maximally available HEOR data while protecting patients' privacy rights. HEOR information is a public good, so private incentives to support creation and operation of this new system remain incomplete. Public and private support can expand this system to optimally improve people's health.
Topics: Humans; Confidentiality; Electronic Health Records; Outcome Assessment, Health Care; Costs and Cost Analysis
PubMed: 37406962
DOI: 10.1016/j.jval.2023.06.012 -
PharmacoEconomics Dec 2023Missing data in costs and/or health outcomes and in confounding variables can create bias in the inference of health economics and outcomes research studies, which in...
BACKGROUND
Missing data in costs and/or health outcomes and in confounding variables can create bias in the inference of health economics and outcomes research studies, which in turn can lead to inappropriate policies. Most of the literature focuses on handling missing data in randomized controlled trials, which are not necessarily always the data used in health economics and outcomes research.
OBJECTIVES
We aimed to provide an overview on missing data issues and how to address incomplete data and report the findings of a systematic literature review of methods used to deal with missing data in health economics and outcomes research studies that focused on cost, utility, and patient-reported outcomes.
METHODS
A systematic search of papers published in English language until the end of the year 2020 was carried out in PubMed. Studies using statistical methods to handle missing data for analyses of cost, utility, or patient-reported outcome data were included, as were reviews and guidance papers on handling missing data for those outcomes. The data extraction was conducted with a focus on the context of the study, the type of missing data, and the methods used to tackle missing data.
RESULTS
From 1433 identified records, 40 papers were included. Thirteen studies were economic evaluations. Thirty studies used multiple imputation with 17 studies using multiple imputation by chained equation, while 15 studies used a complete-case analysis. Seventeen studies addressed missing cost data and 23 studies dealt with missing outcome data. Eleven studies reported a single method while 20 studies used multiple methods to address missing data.
CONCLUSIONS
Several health economics and outcomes research studies did not offer a justification of their approach of handling missing data and some used only a single method without a sensitivity analysis. This systematic literature review highlights the importance of considering the missingness mechanism and including sensitivity analyses when planning, analyzing, and reporting health economics and outcomes research studies.
Topics: Humans; Data Interpretation, Statistical; Bias; Research Design; Cost-Benefit Analysis; Outcome Assessment, Health Care
PubMed: 37490207
DOI: 10.1007/s40273-023-01297-0 -
BMJ (Clinical Research Ed.) Jul 2023To review the evidence on trends and impacts of private equity (PE) ownership of healthcare operators.
OBJECTIVE
To review the evidence on trends and impacts of private equity (PE) ownership of healthcare operators.
DESIGN
Systematic review.
DATA SOURCES
PubMed, Web of Science, Embase, Scopus, and SSRN.
ELIGIBILITY CRITERIA FOR STUDY SELECTION
Empirical research studies of any design that evaluated PE owned healthcare operators.
MAIN OUTCOME MEASURES
The main outcome measures were impact of PE ownership on health outcomes, costs to patients or payers, costs to operators, and quality. The secondary outcome measures were trends and prevalence of PE ownership of healthcare operators.
DATA SYNTHESIS
Studies were classified as finding either beneficial, harmful, mixed, or neutral impacts of PE ownership on main outcome measures. Results across studies were narratively synthesized and reported. Risk of bias was evaluated using ROBINS-I (Risk Of Bias In Non-randomised Studies of Interventions).
RESULTS
The electronic search identified 1778 studies, with 55 meeting the inclusion criteria. Studies spanned eight countries, with most (n=47) analyzing PE ownership of healthcare operators in the US. Nursing homes were the most commonly studied healthcare setting (n=17), followed by hospitals and dermatology settings (n=9 each); ophthalmology (n=7); multiple specialties or general physician groups (n=5); urology (n=4); gastroenterology and orthopedics (n=3 each); surgical centers, fertility, and obstetrics and gynecology (n=2 each); and anesthesia, hospice care, oral or maxillofacial surgery, otolaryngology, and plastics (n=1 each). Across the outcome measures, PE ownership was most consistently associated with increases in costs to patients or payers. Additionally, PE ownership was associated with mixed to harmful impacts on quality. These outcomes held in sensitivity analyses in which only studies with moderate risk of bias were included. Health outcomes showed both beneficial and harmful results, as did costs to operators, but the volume of studies for these outcomes was too low for conclusive interpretation. In some instances, PE ownership was associated with reduced nurse staffing levels or a shift towards lower nursing skill mix. No consistently beneficial impacts of PE ownership were identified.
CONCLUSIONS
Trends in PE ownership rapidly increased across almost all healthcare settings studied. Such ownership is often associated with harmful impacts on costs to patients or payers and mixed to harmful impacts on quality. Owing to risk of bias and frequent geographic focus on the US, conclusions might not be generalizable internationally.
SYSTEMATIC REVIEW REGISTRATION
PROSPERO CRD42022329857.
Topics: Humans; Ownership; Hospitals; Nursing Homes; Health Services; Outcome Assessment, Health Care
PubMed: 37468157
DOI: 10.1136/bmj-2023-075244 -
Thorax Dec 2023There is high heterogeneity of outcomes and measures reported in pulmonary rehabilitation (PR) trials of people with chronic obstructive pulmonary disease (COPD). This...
INTRODUCTION
There is high heterogeneity of outcomes and measures reported in pulmonary rehabilitation (PR) trials of people with chronic obstructive pulmonary disease (COPD). This hinders study comparability and benchmarking of PR. We have developed a core outcome set (COS) to overcome these challenges.
METHODS
This study was informed by a systematic review and two qualitative studies and had patient involvement since its inception. A two-round Delphi survey was available in seven languages. Outcomes (n=63) scored 7-9 (crucial) by ≥70% of the participants and 1-3 (not that important) by ≤15% of participants from both groups in the Likert scale were automatically included in the COS, while outcomes that were considered crucial by only one of the groups were further discussed by the authors in a meeting.
RESULTS
A total of 299 people (n=229 healthcare professionals/researchers/policy-makers; n=70 people with COPD and informal caregivers) participated in the survey (83% retention), which covered 29 countries/five continents. After the second round, six outcomes were included and three were added in the meeting. The final COS contains dyspnoea, fatigue, functional exercise capacity, health-related quality of life, health behaviours/lifestyle, knowledge about the disease, lower limb muscle function, personal goals and problematic activities of daily living.
CONCLUSION
A COS for PR of people with COPD is now available and can be used by different stakeholders to improve consistency and comparability of studies, benchmark PR and improve the quality of care provided. Future research should establish the core measures and investigate the uptake of this COS.
Topics: Humans; Activities of Daily Living; Exercise; Outcome Assessment, Health Care; Pulmonary Disease, Chronic Obstructive; Quality of Life; Treatment Outcome; Delphi Technique
PubMed: 37758457
DOI: 10.1136/thorax-2023-220522 -
Plant Foods For Human Nutrition... Dec 2023Olive oil, as well as by-products and waste that are left after production, particularly olive pomace and olive leaf, have been extensively researched as sources of... (Review)
Review
Olive oil, as well as by-products and waste that are left after production, particularly olive pomace and olive leaf, have been extensively researched as sources of phenolic compounds. These compounds are known for their biological properties and have been associated with the prevention of chronic non-communicable diseases. Metabolomics has been used as a methodological tool to elucidate the molecular mechanisms underlying these properties. The present review explores the health outcomes and changes in endogenous metabolite profiles induced by olive derivatives. A literature search was conducted using the scientific databases Scopus, Web of Science and PubMed, and the selected articles were published between the years 2012 and 2023. The reviewed studies have reported several health benefits of olive derivatives and their phenolic components, including appetite regulation, fewer cardiovascular disorders, and antiproliferative properties. This review also addressed the bioavailability of these compounds, their impact on the microbiota, and described biomarkers of their intake. Therefore, there should be further research using this methodology for a better understanding of the performance and therapeutic potential of olive derivatives.
Topics: Olea; Olive Oil; Phenols; Outcome Assessment, Health Care
PubMed: 37932611
DOI: 10.1007/s11130-023-01119-w -
The American Journal of Managed Care Jul 2023Postacute care (PAC) heavily relies on effective connection between acute and postacute providers. However, little is known about whether and to what extent providers'...
OBJECTIVES
Postacute care (PAC) heavily relies on effective connection between acute and postacute providers. However, little is known about whether and to what extent providers' patient-sharing relationships influence patient outcomes. This study aimed to examine whether patients with stroke who were discharged to PAC hospitals with which the originating hospital had a strong patient-sharing relationship have a lower rate of rehospitalization and lower mortality risk.
STUDY DESIGN
This population-based retrospective cohort study used the Taiwan National Health Insurance Research Database. A total of 1988 patients initially hospitalized for stroke between July 1, 2017, and June 30, 2018, who were newly discharged to 193 PAC hospitals from 175 originating hospitals were included.
METHODS
We described the partnership between originating acute hospitals and PAC hospitals using tie strength and referral concentration. The main outcome included unplanned readmission and mortality. Hierarchical logistic regression analysis and Cox proportional hazards models were applied.
RESULTS
A dose-response relationship was clearly observed between tie strength and patient outcomes. Patients with stroke who were discharged to a PAC hospital that had the strongest tie strength with the originating hospital were least likely to be readmitted and had the lowest mortality risk. Moreover, patients who received care from hospital pairs with highly or moderately concentrated referrals also had lower readmission and mortality risk.
CONCLUSIONS
A greater number of shared patients and a more concentrated referral linkage between acute and PAC providers may reduce potential adverse outcomes in PAC patients. Instead of attaining more partners, PAC policies should encourage providers to strengthen their patient-sharing relationship with their existing PAC partners.
Topics: Humans; Stroke; Patient Discharge; Retrospective Studies; Patient Readmission; Hospitals; Subacute Care; Taiwan; Outcome Assessment, Health Care; Male; Female; Middle Aged; Aged
PubMed: 37523454
DOI: 10.37765/ajmc.2023.89401