Development of the Flu-PRO: a patient-reported outcome (PRO) instrument to evaluate symptoms of influenza

Powers, John H.; Guerrero, M. Lourdes; Leidy, Nancy Kline; Fairchok, Mary; Rosenberg, Alice; Hernández, Andrés; Stringer, Sonja; Schofield, Christina; Rodríguez‐Zulueta, Patricia; Kim, Katherine; Danaher, Patrick; Ortega-Gallegos, Hilda; Bacci, Elizabeth D.; Stepp, Nathaniel; Galindo-Fraga, Arturo; Clair, Kristina St.; Rajnik, Michael; McDonough, Erin A.; Ridoré, Michelande; Arnold, John; Millar, Eugene V.; Ruíz-Palacios, Guillermo M.

doi:10.1186/s12879-015-1330-0

Cited by 318 publications

(356 citation statements)

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“…Chikungunya virus (CHIKV) and dengue virus (DENV) are arboviruses currently circulating in Southeast Asia, Central and West Africa, the Pacific islands, and the Americas, and their transmission can occur simultaneously ( 1 ). DENV and CHIKV co-infections have been reported from 13 of 98 countries/territories to which the viruses are endemic and are more likely to occur in areas with high transmission intensity.…”

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confidence: 99%

“…DENV and CHIKV co-infections have been reported from 13 of 98 countries/territories to which the viruses are endemic and are more likely to occur in areas with high transmission intensity. Co-infection rates reported have ranged from 2% in Gabon to 34% in Nigeria ( 1 – 3 ). …”

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confidence: 99%

“…A total of 2.3 million DENV infections and 635,000 CHIKV infections were reported in this region in 2015 ( 4 , 5 ). However, details of the frequency of co-infection are lacking ( 1 ), although a recent study involving 173 samples from Nicaragua that were positive for either virus found a co-infection rate of 22% ( 6 ). …”

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confidence: 99%

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Co-infections with Chikungunya and Dengue Viruses, Guatemala, 2015

Edwards¹,

Signor²,

Williams³

et al. 2016

Emerg. Infect. Dis.

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confidence: 99%

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confidence: 99%

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Co-infections with Chikungunya and Dengue Viruses, Guatemala, 2015

Edwards¹,

Signor²,

Williams³

et al. 2016

Emerg. Infect. Dis.

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“…Two reviews respectively state that 75% (Steffen et al, 2003) and 65% (Hill, 2006) of travellers to developing countries report a degree of health impairment while abroad. More recently, a study by Vilkman, Pakkanen, Lääveri, Siikamäki, and Kantele (2016) revealed that health care was sought by 10% of overseas tourists and as many as 79% would go on to report that they fell ill while travelling. Further, in contrast with local populations, tourists are believed to be at higher risk of injury due to motor vehicle collision (McInnes, Williamson, & Morrison, 2006), and across all types of unintentional injury, are likely to experience more severe injuries (McInnes et al, 2006; Steffen et al, 2003).…”

Section: Introductionmentioning

confidence: 99%

“…Outside of epidemiological work, some existing literature considers the health risks of travel (e.g., Jackson & Abubakar, 2017; Lüthi & Schlagenhauf, 2015), pedagogical approaches to better inform and prepare tourists for such risks (e.g., Marchand, Merrina, Gagnayre, & Bouchaud, 2017; Seale et al, 2016), and outcomes of this education (e.g., Angelin, Evengård, & Palmgren, 2014; Croughs, Remmen, & Van den Ende, 2014). Such work aims to contextualize the assumption that a confluence of “appropriate pre‐travel advice and patient compliance are … key elements in ensuring that world travelers return home in good health” (McIntosh, 2015, p. 143).…”

Section: Introductionmentioning

confidence: 99%

A challenging entanglement: health care providers’ perspectives on caring for ill and injured tourists on Cozumel Island, Mexico

Hoffman

Crooks

Snyder

2018

International Journal of Qualitative Studies on Health and Well

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Purpose: Despite established knowledge that tourists often fall ill or are injured abroad, little is known about their treatment. The intent of this study was to explore health care professionals’ treatment provision experiences on Cozumel Island, Mexico. Methods: 13 semi-structured interviews were undertaken with professionals across a number of health care vocations on Cozumel Island. Interviews were transcribed and thematically analysed to determine common challenges faced in the provision of treatment for transnational tourists. Results: Three thematic challenges emerged from the data: human and physical resource deficiencies, medical (mis)perceptions held by patients and complexities surrounding remuneration of care. Health care providers employ unique strategies to mitigate these challenges. Conclusion: Although many of these challenges exist within other touristic and peripheral spaces, we suggest that the challenges experienced by Cozumel Island’s health care professionals, and their mitigation strategies, exist as part of a complex entanglement between the island’s health care sector and its dominant tourism landscape. We call on tangential tourism services to take a larger role in ensuring the ease of access to, and provision of quality health care services for tourists on Cozumel Island.

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US Food and Drug Administration Recommendations on the Use of Surrogate Measures as End Points in New Anti-infective Drug Approvals

Hey

Kesselheim

Patel³

et al. 2020

JAMA Intern Med

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linicians and patients need to know if new medical interventions improve survival, patient function, or symptoms. Optimally, clinical trials would directly evaluate these outcomes, consistent with regulatory agencies moving toward more patient-focused drug development. 1 However, many clinical trials evaluate new medicines on the basis of indirect (also called surrogate) outcomes, which a US Food and Drug Administration (FDA) and National Institutes of Health (NIH) working group defined as trial end points that "substitute for a direct measure of how a patient feels, functions, or survives." 2(p48) Indirect measures include physical signs, biomarkers, and other laboratory-based measures.The FDA and NIH further categorize indirect outcomes based on the level of evidence that they reflect direct patient benefit. 2 Validated surrogates are supported by a clear mechanistic rationale and clinical data that provide strong evidence that an effect on the sur-rogate predicts clinical benefit. Reasonably likely surrogates are supported by mechanistic or epidemiologic rationales, but there are not sufficient data showing that they predict clinical benefits. Candidate surrogates are under evaluation, but there is not yet sufficient rationale or evidence to be classified as either validated or reasonably likely surrogates.Almost half of recent FDA drug approvals are based on pivotal trials that use surrogate outcomes as the primary trial end points. 3 The FDA has released a list of surrogate outcomes (with various levels of supporting evidence) that have been used as primary end points in pivotal clinical trials 4 and the 21st Century Cures Act of 2016 encourages the FDA to make even greater use of surrogate outcomes as the basis for new drug approvals. 5 The FDA can grant a new product accelerated approval based on a reasonably likely surrogate, or standard approval on the basis of a surrogate shown by clini-IMPORTANCE Regulatory and scientific guidelines stipulate that indirect, surrogate measures of patient benefit, such as a change in microbial culture status, should be used as primary end points only in pivotal trials of chronic conditions that are serious or life threatening and when the experimental therapy is expected to offer substantial benefit compared with available therapy. However, many recent US Food and Drug Administration (FDA) anti-infective drug approvals for acute and/or non-life-threatening diseases have been based on pivotal trials using surrogate measures as primary end points rather than clinical outcomes, such as symptom resolution or survival.OBJECTIVES To review FDA recommendations for primary end points in pivotal trials of new anti-infective drugs and assess the concordance of those recommendations with the regulatory and scientific conditions for the appropriate use of surrogate measures as primary trial outcomes.EVIDENCE REVIEW All guidance documents for antimicrobial drug development hosted on the FDA website were searched in November 2017; the search was updated in June 2018. For each docume...

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Development of the Flu-PRO: a patient-reported outcome (PRO) instrument to evaluate symptoms of influenza

Cited by 318 publications

References 7 publications

Co-infections with Chikungunya and Dengue Viruses, Guatemala, 2015

Co-infections with Chikungunya and Dengue Viruses, Guatemala, 2015

A challenging entanglement: health care providers’ perspectives on caring for ill and injured tourists on Cozumel Island, Mexico

US Food and Drug Administration Recommendations on the Use of Surrogate Measures as End Points in New Anti-infective Drug Approvals

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