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RA Linked to Higher Health Burden, Lower HRQoL in Pre-RA

Patients with RA reported worse outcomes for all PROMs compared with CSA or UA.

United-kingdom , Barbara-torlinska , Institute-of-applied-health-research , University-of-birmingham , Patient-health-questionnaire , Health-survey-for-england , Centre-for-patient , Outcomes-research , Visible-analytics , Patient-reported-outcomes-research , Applied-health-research , Birmingham-early-arthritis

New recommendations make it easier for patients to give feedback on their health

New recommendations make it easier for patients to give feedback on their health
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Lee-aiyegbusi , Olalekan-lee-aiyegbusi , Birmingham-biomedical-research-center , Patient-reported-outcomes-research , Research-collaboration , University-of-birmingham , Biomedical-research-center , Applied-research-collaboration , Nature-medicine ,

Enhancing reporting quality and impact of early phase dose-finding clinical trials: CONSORT Dose-finding Extension (CONSORT-DEFINE) guidance

The CONSORT (CONsolidated Standards Of Reporting Trials) 2010 statement is the standard guideline for reporting completed randomised trials. The CONSORT Dose-finding Extension (DEFINE) extends the guidance (with 21 new items and 19 modified items) to early phase dose-finding trials with interim dose escalation or de-escalation strategies. Such trials generally focus on safety, tolerability, activity, and recommending dosing and scheduling regimens for further clinical development. These trials are often inadequately reported, hampering their informativeness and making evidence informed decisions difficult. The CONSORT-DEFINE guidance aims to develop an international, consensus driven guideline for reporting early phase dose-finding trials to promote transparency, completeness, reproducibility, and facilitate the interpretation of the results. The CONSORT-DEFINE guidance provides recommendations for essential items that should be reported in early phase dose-finding trials to promote greater clarity, reproducibility, informativeness, and usefulness of results.

Early phase dose-finding (EPDF) or dose escalation or de-escalation trials, commonly known as phase 1 or phase 1 or 2 trials, are an integral part of clinical development. EPDF trials typically evaluate new interventions that can be given in different doses and can be pharmacological (chemical or biological—eg, drugs, vaccines, cell therapies, gene therapies), non-pharmacological (eg, radiotherapy, rehabilitation, devices, digital therapies), or a combination of both. These trials require interim decisions on dosing changes of an intervention and generate data on safety and other information such as pharmacokinetics, pharmacodynamics, biomarker, or clinical activity to guide dosing selection and future clinical development.1234 In this article, a broad definition of “dose” is applied, because terms such as “dose finding,” “dose escalation,” “dose de-escalation,” “dose expansion,” and “dose level” are widely used. Here, dose might refer not only to the amount but also to the frequency, intensity, or duration of an intervention.5 The term could therefore be regarded as synonymous and used interchangeably …

Canada , Australia , Glasgow , Glasgow-city , United-kingdom , West-midlands , United-kingdom-general- , Maastricht , Limburg , Netherlands , United-states , Scotland

Enhancing quality and impact of early phase dose-finding clinical trial protocols: SPIRIT Dose-finding Extension (SPIRIT-DEFINE) guidance

SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 provides guidance for clinical trial protocol writing. However, neither the original guidance nor its extensions adequately cover the features of early phase dose-finding trials. The SPIRIT Dose-finding Extension (DEFINE) statement is a new guideline that provides recommendations for essential items that should be provided in the protocols of these trials. It details extensions to the SPIRIT 2013 guidance, incorporating 17 new items and modifying 15 existing items. The purpose of this guideline is to promote transparency, completeness, reproducibility of methods, and interpretation of early phase dose-finding trial protocols. It is envisioned that the resulting improvements in the design and conduct of early phase clinical trials will ultimately reduce research inefficiencies and inconsistencies, driving transformational advances in clinical care.

Developing an intervention is a lengthy process pursued in stages where decisions are based on balance of benefits and risks or harms of the intervention under investigation. Lack of efficacy or evidence of harm due to adverse safety profiles are common reasons for phase 2 and phase 3 trials to be unsuccessful.12 Phase 3 trial failures can reflect incorrect decisions made at earlier stages, including in early phase dose-finding (EPDF) trials (commonly known as phase 1, phase 1/2, or first-in-human trials). Reasons why interventions do not progress or succeed in later stages of clinical development include misleading preclinical studies, inadequate participant selection, inefficient trial design, suboptimal biomarker or outcome choices, and poor dose selection. The same reasons can also contribute to early discontinuation of promising interventions.

EPDF trials typically evaluate new interventions that can be used in different doses and can be pharmacological (chemical or biological—eg, drugs, vaccines, cell therapies, gene therapies), non-pharmacological (eg, radiotherapy, devices, rehabilitation, digital therapies), or a combination of both. They usually include a small number of …

Canada , Glasgow , Glasgow-city , United-kingdom , Australia , Maastricht , Limburg , Netherlands , West-midlands , United-kingdom-general- , United-states , Canadian

New Tools Boost Public, Patient Involvement in Health Research

New Tools Boost Public, Patient Involvement in Health Research
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West-midlands , United-kingdom-general- , United-kingdom , Melanie-calvert , Lee-aiyegbusi , Study-group , University-of-birmingham , Research-collaboration-west-midlands , United-kingdom-national-institute-for-health , University-of-birmingham-centre-for-patient , Outcomes-research , Birmingham-biomedical-research-centre

New resources to improve patient and public involvement in health research

New resources to improve patient and public involvement in health research
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Lee-aiyegbusi , Melanie-calvert , University-of-birmingham , Outcomes-research , Birmingham-biomedical-research-centre , Study-group , University-of-birmingham-centre-for-patient , Research-collaboration-west-midlands , Nature-medicine , Applied-health-research , Biomedical-research-centre , Patient-reported-outcomes-research

The Evolution and Impact of ePROs in Clinical Trials, Upcoming Webinar Hosted by Xtalks

Toronto, ON (PRWEB) April 17, 2023 -- This webinar will examine the importance of electronic patient-reported outcomes (ePROs) and how working at pace with

Melanie-calvert , Christel-mcmullan , Sarah-hughes , Vera-kovacevic , Honeycomb-worldwide-inc , Qualitative-research , Institute-of-applied-health-research , Centre-for-patient-reported-outcomes-research , University-of-birmingham , Symptom-burden-questionnaire , Outcomes-methodology , Research-fellow

After 25 Years of AI Health Tech Research Computers are Slowly Beginning to Listen to Patients

Patients experiences of health conditions are slowly being integrated into healthcare AI studies, a review of 25 years of studies has found.

Samantha-cruz-rivera , Megan-craig , Melanie-calvert , University-of-birmingham , Chronic-health-leading-the-way , National-institute-for-health , Centre-for-patient-reported-outcomes-research , Lancet-digital-health , University-hospitals-birmingham , Birmingham-biomedical-research-centre , Care-research , National-institute

Outpatient waiting lines may be reduced via remote symptom reporting systems: Research

According to a new assessment published in the Journal of the Royal Society of Medicine, digital systems for patients to remotely monitor and report symptoms may offer a way to minimise outpatient waiting lines.

Lee-aiyegbusi , Centre-for-patient-reported-outcomes-research , Institute-of-applied-health-research , Journal-of-the-royal-society-medicine , University-of-birmingham , Royal-society , Patient-reported-outcomes-research , Applied-health-research , Denmark-ambuflex , Associate-professor , Deputy-director , Epilepsy-clinics

Health News | Outpatient Waiting Lines May Be Reduced Via Remote Symptom Reporting Systems: Research

Get latest articles and stories on Health at LatestLY. According to a new assessment published in the Journal of the Royal Society of Medicine, digital systems for patients to remotely monitor and report symptoms may offer a way to minimise outpatient waiting lines. Health News | Outpatient Waiting Lines May Be Reduced Via Remote Symptom Reporting Systems: Research.

Washington , United-states , Lee-aiyegbusi , Centre-for-patient-reported-outcomes-research , Institute-of-applied-health-research , Journal-of-the-royal-society-medicine , University-of-birmingham , Royal-society , Patient-reported-outcomes-research , Applied-health-research , Denmark-ambuflex , Associate-professor