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Claire M. Ervin David S. Reasner Jennifer T. Hanlon Sheri E. Fehnel 《Advances in therapy》2017,34(12):2680-2692
Introduction
To improve understanding of the diabetic gastroparesis (DGP) patient experience and inform the patient-reported outcome measurement strategy for future trials in DGP, qualitative interviews were conducted with participants in a phase 2 clinical trial of a novel DGP treatment.Methods
Trial participants were invited to participate in interviews at both the pretreatment visit (PTV) and the end-of-treatment visit (EOTV). The interviews were conducted by experienced qualitative researchers and followed a semistructured interview guide. The PTV interviews focused on patients’ DGP symptoms and the impact of DGP on their lives, and the EOTV interviews focused on any symptom changes patients experienced during the trial.Results
Of 90 enrolled trial participants, 78 (86.7%) opted to participate in the interview study. Bloating, stomach fullness, upper abdominal pain, vomiting, constipation, and heartburn or reflux were each reported spontaneously by a majority of the 73 PTV interview participants with evaluable data. These patients commonly reported bloating (n = 20), upper abdominal pain (n = 12), and nausea (n = 11) as their most bothersome DGP symptom. Of 51 EOTV interview participants, 44 (86.3%) reported improvement in at least one DGP symptom either spontaneously or when asked about specific symptoms reported during their PTV interview.Conclusion
Bloating, abdominal pain, nausea, constipation, stomach fullness, vomiting, and heartburn were frequently reported by patients as the most bothersome and important-to-treat symptoms. These results support the assessment of these symptoms in future DGP clinical trials, whether for symptom improvement or worsening.Funding
Ironwood Pharmaceuticals.Trial Registration
ClinicalTrials.gov identifier NCT02289846.12.
Yves Longtin Hugo Sax Lucian L. Leape Susan E. Sheridan Liam Donaldson Didier Pittet 《Mayo Clinic proceedings. Mayo Clinic》2010,85(1):53-62
Patient participation is increasingly recognized as a key component in the redesign of health care processes and is advocated as a means to improve patient safety. The concept has been successfully applied to various areas of patient care, such as decision making and the management of chronic diseases. We review the origins of patient participation, discuss the published evidence on its efficacy, and summarize the factors influencing its implementation. Patient-related factors, such as acceptance of the new patient role, lack of medical knowledge, lack of confidence, comorbidity, and various sociodemographic parameters, all affect willingness to participate in the health care process. Among health care workers, the acceptance and promotion of patient participation are influenced by other issues, including the desire to maintain control, lack of time, personal beliefs, type of illness, and training in patient-caregiver relationships. Social status, specialty, ethnic origin, and the stakes involved also influence patient and health care worker acceptance. The London Declaration, endorsed by the World Health Organization World Alliance for Patient Safety, calls for a greater role for patients to improve the safety of health care worldwide. Patient participation in hand hygiene promotion among staff to prevent health care—associated infection is discussed as an illustrative example. A conceptual model including key factors that influence participation and invite patients to contribute to error prevention is proposed. Further research is essential to establish key determinants for the success of patient participation in reducing medical errors and in improving patient safety.Patient participation is a complex concept and arises from the widespread consumer movement of the 1960s that affirmed the consumer''s right to safety, the right to be informed, the right to choose, and the right to be heard.1 During the past few years, patient participation has been increasingly recognized as a key component in the redesign of health care processes and successfully applied to some aspects of patient care, notably the decision-making process and the treatment of chronic illness. Recently, increasing patient participation has been recommended to improve patient safety. The World Health Organization (WHO) World Alliance for Patient Safety is actively highlighting the role that patients and their families could play in the improvement of health care.2 However, this field of patient participation has not been widely researched thus far.We review the underlying principles and the efficacy of patient participation in decision making and self-treatment of chronic illness, as well as the potential obstacles to implementation. Building on these principles, we develop a conceptual framework for patient participation. Finally, we suggest that patient participation could be useful to improve quality of care and prevent medical errors and propose an agenda for research. 相似文献
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Prashanth Sunkureddi Dawn Gibson Stephen Doogan John Heid Samir Benosman Yujin Park 《Advances in therapy》2018,35(3):424-437
Introduction
Online communities contain a wealth of information containing unsolicited patient experiences that may go beyond what is captured by guided surveys or patient-reported outcome (PRO) instruments used in clinical settings. This study described patient experiences reported online to better understand the day-to-day disease burden of ankylosing spondylitis (AS).Methods
Unguided, English-language patient narratives reported between January 2010 and May 2016 were collected from 52 online sources (e.g., general/health social networking sites, patient–physician Q&A sites, AS forums). Using natural language processing combined with manual curation, patient-reported experiences within narratives were evaluated and categorized into social, physical, emotional, cognitive, and role activity (SPEC-R) concepts to assess functional impairment. The same SPEC-R categorization was applied to 5 AS-specific PRO instruments to evaluate their coverage of concepts extracted from patient narratives.Results
A total of 34,780 narratives from 3449 patients with AS were included. Physical aspects of AS (e.g., pain and mobility) were most commonly reported by patients (86.7%), followed by emotional (32.5%), cognitive (23.6%), role activity (8.7%) and social (5.1%). Some frequently discussed subconcepts were effectively captured by ≥ 2 PRO instruments, such as pain (65.3%), asthenia (19.9%), musculoskeletal impairment (19.9%), depression (9.9%), and anger/frustration (5.4%); others [e.g., anxiety (19.1%), mental impairment (3.2%), impulsivity (2.9%)] were not addressed by any of the PRO instruments.Conclusion
These findings highlight the importance of analyzing patient experiences beyond clinical trial settings and physician reports; continuous assessment of existing PRO instruments in collaboration with patients may increase their utility in real-world settings.Funding
Novartis Pharmaceuticals Corporation.19.
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