4 research outputs found

    Patient and stakeholder engagement learnings: PREP-IT as a case study

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    Limiting Factors of Five Rare Plant Species in Mesic Forests, Hawai\u27i Volcanoes National Park

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    Five rare or endangered plant species native to Kīpuka Puaulu and Kīpuka Kī were studied for two years to determine their stand structure, patterns of reproductive phenology, success of fruit production, potential pollinators, greenhouse seed germination rates, presence of soil seed banks, impacts of seed-predating rats, seed predation by insects, seedling predation by Kalij pheasant (Lophura leucomelanos), and seedling survival with different treatments. Species monitored were the trees Hibiscadelphus giffardianus (hau kuahiwi), Melicope hawaiensis (manena), M. zahlbruckneri (alani), and Zanthoxylum dipetalum var. dipetalum (kāwa`u), and the vine Sicyos macrophyllus (`ānunu). Limiting factors identified for H. giffardianus were rat predation of seeds, bark-stripping, low fruit production likely resulting from the inter-relatedness of the planted population, and loss of original pollinators. For M. hawaiensis, rat and native insect predation of seeds limited the number of seeds available, and natural seedling recruitment was very low. Pollination was effected by an alien insect species. For M. zahlbruckneri, native insect predation and rat depredation greatly reduced the number of seeds available for germination. The low proportion of flowers that became fruit indicated a lack of successful pollination or self-incompatibility. For S. macrophyllus, rat predation of seeds on the ground and in the seed bank reduced the number of seeds available for natural regeneration. Alien grasses were suspected to limit seedling recruitment. Most floral visitors were alien insect species. Seedling recruitment appeared to be the most vulnerable life stage for Z. dipetalum var. dipetalum. Both alien Kalij pheasants and unknown insect species were implicated as seedling predators/herbivores

    Implementing stakeholder engagement to explore alternative models of consent: An example from the PREP-IT trials

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    Introduction: Cluster randomized crossover trials are often faced with a dilemma when selecting an optimal model of consent, as the traditional model of obtaining informed consent from participant's before initiating any trial related activities may not be suitable. We describe our experience of engaging patient advisors to identify an optimal model of consent for the PREP-IT trials. This paper also examines surrogate measures of success for the selected model of consent. Methods: The PREP-IT program consists of two multi-center cluster randomized crossover trials that engaged patient advisors to determine an optimal model of consent. Patient advisors and stakeholders met regularly and reached consensus on decisions related to the trial design including the model for consent. Patient advisors provided valuable insight on how key decisions on trial design and conduct would be received by participants and the impact these decisions will have. Results: Patient advisors, together with stakeholders, reviewed the pros and cons and the requirements for the traditional model of consent, deferred consent, and waiver of consent. Collectively, they agreed upon a deferred consent model, in which patients may be approached for consent after their fracture surgery and prior to data collection. The consent rate in PREP-IT is 80.7%, and 0.67% of participants have withdrawn consent for participation. Discussion: Involvement of patient advisors in the development of an optimal model of consent has been successful. Engagement of patient advisors is recommended for other large trials where the traditional model of consent may not be optimal
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