ePRO and Medication Adherence in Clinical Trails
Read some articles that show the importance of ePRO and medication adherence in Clinical Trails
Digitally Enabled, Patient‐Centric Clinical Trials: Shifting the Drug Development Paradigm
The rapidly advancing field of digital health technologies provides a great opportunity to radically transform the way clinical trials are conducted and to shift the clinical trial paradigm from a site‐centric to a patient‐centric model.
FDA Takes Additional Steps to Advance Decentralized Clinical Trials
Decentralizing clinical trials will allow some or all trial-related activities to take place at trial participants’ homes or other convenient locations, instead of having them visit research sites. By reducing barriers to participation, we expect that DCTs will increase the breadth and diversity of participants in clinical trials and improve accessibility for those with rare diseases or mobility challenges.
Digital Health Technologies for Remote Data Acquisition in Clinical Investigations
A digital health technology2 (DHT) is a system that uses computing platforms, connectivity, software, and/or sensors, for health care and related uses. This guidance provides recommendations for sponsors, investigators, and other stakeholders on the use of DHTs for remote data acquisition3 from participants in clinical investigations that evaluate medical products.
How the EMERGE guideline on medication adherence can improve the quality of clinical trials
Medication adherence in drug trials is suboptimal, affecting the quality of these studies and adding significant costs. Nonadherence in this setting can lead to null findings, unduly large sample sizes and the need for dose modification after a drug has been approved.
Digital symptom monitoring with patient-reported outcomes in community oncology practices: A U.S. national cluster randomized trial.
Symptoms are common during cancer care but often go undetected. Digital systems that elicit patient-reported outcomes (PRO) surveys may detect symptoms early and prompt clinicians to intervene, thereby alleviating suffering and averting complications.
Assessing the Quality of Transitional Care
Further Applications of the Care Transitions Measure
Following endorsement by National Quality Forum, findings support use of the CTM in national public reporting efforts. The 3-item CTM closely approximates the 15-item instrument and may be attractive to purchasers and health care organizations that want to assess quality in this area while minimizing cost and response burden.
Electronic Patient-Reported Outcomes: The Time Is Ripe for Integration Into Patient Care and Clinical Research
A patient-reported outcome is defined as a measurement of the patient’s condition, reported directly by the patient without interpretation by a clinician or any other individual. Collecting PROs allows clinicians to longitudinally monitor a patient’s tolerance of therapy, response to therapy, and symptoms that result from the underlying disease or treatment.
The Importance of Assessing Drug Exposure and Medication Adherence in Evaluating Investigational Medications: Ensuring Validity and Reliability of Clinical Trial Results
The objective of this current opinion paper is to draw global attention to medication adherence, emphasizing its crucial role in drug trials.
RTM and Medication Adherence Related Articles
Read some articles that show the importance of RTM and medication adherence on our health
The Future of Remote Patient Monitoring
Digital health advocates believe remote monitoring—the use of digital technologies to collect and relay patient data to health care professionals—has the potential to transform disease management, health outcomes, and patient care, especially for individuals with multiple chronic conditions who lack convenient access to providers. Medicare, most state Medicaid agencies, and many private health insurance plans cover remote monitoring services.
Expanding Mental Health Care Access—Remote Therapeutic Monitoring for Cognitive Behavioral Therapy
Remote patient monitoring involves the use of technology to monitor patient health outside of the traditional health care setting, ie, clinics and hospitals. Historically, mental health clinicians (eg, psychiatrists, nurse practitioners, psychologists, social workers) have not been incentivized in the same ways as other clinicians to monitor their patients in between visits. The addition of Current Procedural Terminology (CPT) codes for remote therapeutic monitoring (RTM) presents an opportunity to address this disparity and improve mental health care. However, adoption may be limited by uncertainty in billing and documentation requirements. This Viewpoint explores the development of RTM, as well as the potential challenges to and opportunities for reducing uncertainty and encouraging adoption of this innovative treatment model by mental health care practitioners.
Medicare Remote Therapeutic Monitoring: Top FAQs for 2023
What Is Remote Therapeutic Monitoring?
RTM is designed for the management of patients under a specific treatment plan using medical devices that collect non-physiological data related to signs, symptoms, and functions of a therapeutic response that provide a functionally integrative representation of patient status.
Remote Monitoring Services Under Review: Update on Potential Medicare Coverage Policies (May 2023 Update)
A recent multijurisdictional CAC meeting held by six of the seven MACs gave stakeholders an initial opportunity to provide feedback on the strength of clinical evidence to support Medicare coverage for RPM and RTM services for non-implantable medical devices. We previewed how this meeting may influence the development of Medicare local coverage determinations in a recent article.
REMOTE MONITORING AND DIGITAL THERAPIES: CMS UPDATES COVERAGE AND PAYMENT POLICIES November 14, 2023
In recent years, the Centers for Medicare & Medicaid Services (CMS) has expanded payment for remote monitoring services in an effort to pay for non-face-to-face services that improve care coordination for Medicare beneficiaries. On November 2, 2023, CMS released the calendar year 2024 final rule for services reimbursed under the Medicare Physician Fee Schedule. In the final rule, CMS clarified certain guidance for remote monitoring services, finalized separate reimbursement for remote monitoring provided by rural health centers and federally qualified health centers, and discussed a recent request for information for digital therapies.