Search Results - "Jandhyala, Ravi"

Delphi, non-RAND modified Delphi, RAND/UCLA appropriateness method and a novel group awareness and consensus methodology for consensus measurement: a systematic literature review by Jandhyala, Ravi

“…Increasing demand for reliable evidence in patient care and its delivery has necessitated the development of several approaches for generating quality…”
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Design, validation and implementation of the post-acute (long) COVID-19 quality of life (PAC-19QoL) instrument by Jandhyala, Ravi

“…The novel coronavirus (SARS-CoV-2) has led to a global pandemic, resulting in a disease termed COVID-19, which commonly presents in adults as a typical…”
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Neutral theory: applicability and neutrality of using generic health-related quality of life tools in diseases or conditions where specific tools are available by Jandhyala, Ravi

“…Health-related quality of life (HRQoL) tools are limited by the indicators included in the construct and variation in interpretation by different researchers…”
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Neutral theory: applicability and neutrality of clinical study endpoints where a disease-specific instrument is available by Jandhyala, Ravi

“…There is a pressing need to improve the accuracy of rare disease clinical study endpoints. Neutral theory, first described here, can be used to assess the…”
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Concordance between the schedule for the evaluation of individual quality of life-direct weighting (SEIQoL-DW) and the EuroQoL-5D (EQ-5D) measures of quality of life outcomes in adults with X-linked hypophosphatemia by Jandhyala, Ravi

“…Accurate measurement of any constructs in clinical studies is of critical importance, especially if the adoption of an intervention relies on detecting a…”
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Development of a Definition for Medical Affairs Using the Jandhyala Method for Observing Consensus Opinion Among Medical Affairs Pharmaceutical Physicians by Jandhyala, Ravi

“…: There is currently no standard definition of medical affairs, despite its increasing importance to the pharmaceutical industry. The evolution of medical…”
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The effect of adding real-world evidence to regulatory submissions on the breadth of population indicated for rare disease medicine treatment by the European Medicines Agency by Jandhyala, Ravi

“…Despite calls for the use of additional real-world evidence (RWE) during drug development, rates of inclusion at the regulatory stage remain low. The medicine…”
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Professional qualifications of medical affairs pharmaceutical physicians and other internal stakeholders in the pharmaceutical industry [version 1; peer review: 1 approved, 1 approved with reservations] by Jandhyala, Ravi

“…Background: Medical affairs pharmaceutical physicians (MAPPs) have unique value to pharmaceutical companies due to their accountability for activities that…”
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Professional qualifications of medical affairs pharmaceutical physicians and other internal stakeholders in the pharmaceutical industry [version 2; peer review: 2 approved] by Jandhyala, Ravi

“…Background: Medical affairs pharmaceutical physicians (MAPPs) have unique value to pharmaceutical companies due to their accountability for activities that…”
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FGF23 and its role in X-linked hypophosphatemia-related morbidity by Beck-Nielsen, Signe Sparre, Mughal, Zulf, Haffner, Dieter, Nilsson, Ola, Levtchenko, Elena, Ariceta, Gema, de Lucas Collantes, Carmen, Schnabel, Dirk, Jandhyala, Ravi, Mäkitie, Outi

“…X-linked hypophosphatemia (XLH) is an inherited disease of phosphate metabolism in which inactivating mutations of the Phosphate Regulating Endopeptidase…”
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Efficacy of Rapid-Onset Oral Fentanyl Formulations vs. Oral Morphine for Cancer-Related Breakthrough Pain: A Meta-Analysis of Comparative Trials by Jandhyala, Ravi, MSc, MBBS, MRCS, Fullarton, John R., BSc, PhD, Bennett, Michael I., MB, ChB, MD (Hons), FRCP, FFPMRCA

“…Abstract Context Breakthrough cancer pain (BTcP) is widely recognized as a clinically significant complication of chronic cancer pain. With most BTcP episodes…”
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The international X-linked hypophosphataemia (XLH) registry (NCT03193476): rationale for and description of an international, observational study by Padidela, Raja, Nilsson, Ola, Makitie, Outi, Beck-Nielsen, Signe, Ariceta, Gema, Schnabel, Dirk, Brandi, Maria Luisa, Boot, Annemieke, Levtchenko, Elena, Smyth, Michael, Jandhyala, Ravi, Mughal, Zulf

“…Background X-linked hypophosphataemia (XLH) is a rare, hereditary, progressive and lifelong phosphate wasting disorder characterised by pathological elevations…”
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Estimation of Reduction in Influenza Vaccine Effectiveness Due to Egg-Adaptation Changes-Systematic Literature Review and Expert Consensus by Ortiz de Lejarazu-Leonardo, Raul, Montomoli, Emanuele, Wojcik, Radek, Christopher, Solomon, Mosnier, Anne, Pariani, Elena, Trilla Garcia, Antoni, Fickenscher, Helmut, Gärtner, Barbara C, Jandhyala, Ravi, Zambon, Maria, Moore, Catherine

“…Influenza vaccines are the main tool to prevent morbidity and mortality of the disease; however, egg adaptations associated with the choice of the…”
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Commercial impact of adding real-world evidence to clinical trials at regulatory approval: a Markovian-like transition model by Jandhyala, Ravi

“…Regulatory use of real-world evidence (RWE) has been recognized as a useful supplement to clinical trial evidence and could benefit patients by reducing time…”
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Development of a definition for real-world evidence using the Jandhyala method for observing consensus opinion among medical affairs pharmaceutical physicians by Jandhyala, Ravi

“…Low rates of inclusion of real-world evidence (RWE) during regulation may arise from lack of clarity and consensus on its definition. A conceptually mature…”
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Guest editor foreword: real-world evidence and medical affairs by Jandhyala, Ravi

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Development, validation and implementation of the medical affairs pharmaceutical physician work-related quality of life instrument by Jandhyala, Ravi

“…Medical affairs pharmaceutical physicians (MAPPs) are at risk for low work-related quality of life (WRQoL). The aim of this study was to develop, validate and…”
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A novel method for observing proportional group awareness and consensus of items arising from list-generating questioning by Jandhyala, Ravi

“…Background: Current healthcare professional consensus-generating methodologies work by forcing consensus, which risks corrupting original opinions and often…”
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The multiple stakeholder approach to real-world evidence (RWE) generation: observing multidisciplinary expert consensus on quality indicators of rare disease patient registries (RDRs) by Jandhyala, Ravi

“…Those invested in the outcome of specific decisions may seek to inform the decision-maker by generating relevant evidence. With multiple decision-makers, the…”
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Comment on: “Patient Registries: An Underused Resource for Medicines Evaluation: Operational Proposals for Increasing the Use of Patient Registries in Regulatory Assessments” by Jandhyala, Ravi

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