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- Janssens, Rosanne, et al.
(författare)
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Patient Preferences in the Medical Product Life Cycle : What do Stakeholders Think? Semi-Structured Qualitative Interviews in Europe and the USA
- 2019
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Ingår i: Patient. - : Springer Science and Business Media LLC. - 1178-1653 .- 1178-1661. ; 12:5, s. 513-526
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Tidskriftsartikel (refereegranskat)abstract
- BackgroundPatient preferences (PP), which are investigated in PP studies using qualitative or quantitative methods, are a growing area of interest to the following stakeholders involved in the medical product lifecycle: academics, health technology assessment bodies, payers, industry, patients, physicians, and regulators. However, the use of PP in decisions along the medical product lifecycle remains limited. As the adoption of PP heavily relies on these stakeholders, knowledge of their perceptions of PP is critical.ObjectiveThis study aimed to characterize stakeholders’ attitudes, needs, and concerns with respect to PP in decision making along the medical product lifecycle.MethodsSemi-structured interviews (n = 143) were conducted with academics (n = 24), health technology assessment/payer representatives (n = 24), industry representatives (n = 24), patients, caregivers and patient representatives (n = 24), physicians (n = 24), and regulators (n = 23) from seven European countries and the USA. Interviews were conducted between April and August 2017. The framework method was used to organize the data and identify themes and key findings in each interviewed stakeholder group.ResultsInterviewees reported being unfamiliar (43%), moderately familiar (42%), or very familiar (15%) with preference methods and studies. Interviewees across stakeholder groups generally supported the idea of using PP in the medical product lifecycle but expressed mixed opinions about the feasibility and impact of using PP in decision making. Interviewees from all stakeholder groups stressed the importance of increasing stakeholders’ understanding of the concept of PP and preference methods and ensuring patients’ understanding of the questions asked in PP studies. Key concerns and needs in each interviewed stakeholder group were as follows: (1) academics: investigating the validity, reliability, reproducibility, and generalizability of preference methods; (2) health technology assessment/payer representatives: developing quality criteria for evaluating PP studies and gaining insights into how to weigh them in reimbursement/payer decision making; (3) industry representatives: obtaining guidance on PP studies and recognition on the importance of PP from decision makers; (4) patients, caregivers, and patient representatives: providing an incentive and adequate information towards patients when participating in PP studies; (5) physicians: avoiding bias as a result of commercial agendas in PP studies and clarifying how to deal with subjective and emotional elements when measuring PP; and (6) regulators: avoiding the misuse of PP study results to overrule the traditional efficacy and safety criteria used for marketing authorization and obtaining robust PP study results.ConclusionsDespite the interest all interviewed stakeholder groups reported in PP, the effective use of PP in decision making across the medical product lifecycle is currently hampered by a lack of standardization and consensus on how to both measure and use PP.
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- Mourad, Ghassan, 1974-, et al.
(författare)
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Depressive Symptoms, Cardiac Anxiety, and Fear of Body Sensations in Patients with Non-Cardiac Chest Pain, and Their Relation to Healthcare-Seeking Behavior : A Cross-Sectional Study
- 2016
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Ingår i: The patient. - : ADIS INT LTD. - 1178-1653. ; 9:1, s. 69-77
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Patients with non-cardiac chest pain (NCCP) suffer from recurrent chest pain and make substantial use of healthcare resources.OBJECTIVE: To explore the prevalence of depressive symptoms, cardiac anxiety, and fear of body sensations in patients discharged with a NCCP diagnosis; and to describe how depressive symptoms, cardiac anxiety, and fear of body sensations are related to each other and to healthcare-seeking behavior.METHODS: Cross-sectional design. Data were collected between late October 2013 and early January 2014 in 552 patients with NCCP from four hospitals in southeast Sweden, using the Patient Health Questionnaire-9, Cardiac Anxiety Questionnaire, and Body Sensations Questionnaire.RESULTS: About 26 % (n = 141) of the study participants reported at least moderate depressive symptoms, 42 % (n = 229) reported at least moderate cardiac anxiety, and 62 % (n = 337) reported some degree of fear of body sensations. We found strong positive relationships between depressive symptoms and cardiac anxiety (r s = 0.49; P < 0.01), depressive symptoms and fear of body sensations (r s = 0.50; P < 0.01), and cardiac anxiety and fear of body sensations (r s = 0.56; P < 0.01). About 60 % of the participants sought care because of chest pain once, 26 % two or three times, and the rest more than three times. In a multivariable regression analysis, and after adjustment for multimorbidity, cardiac anxiety was the only variable independently associated with healthcare-seeking behavior.CONCLUSION: Patients with NCCP and many healthcare consultations had high levels of depressive symptoms and cardiac anxiety, and moderate levels of fear of body sensations. Cardiac anxiety had the strongest relationship with healthcare-seeking behavior and may therefore be an important target for intervention to alleviate suffering and to reduce healthcare use and costs.
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- Schölin Bywall, Karin, et al.
(författare)
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Patient Perspectives on the Value of Patient Preference Information in Regulatory Decision Making : A Qualitative Study in Swedish Patients with Rheumatoid Arthritis
- 2019
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Ingår i: Patient. - : Springer Science and Business Media LLC. - 1178-1653 .- 1178-1661. ; 12:3, s. 297-305
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Tidskriftsartikel (refereegranskat)abstract
- BackgroundThere is increasing interest in involving patient preferences for benefits and risks in regulatory decision making. Therefore, it is essential to identify patient perspectives regarding the value of patient preference information (PPI).ObjectivesThe aim of this study was to explore how patients with rheumatoid arthritis (RA) value the use of PPI in regulatory decision making regarding medical products.MethodsRegulators and patients with RA were interviewed to gather initial insights into opinions on the use of PPI in regulatory decisions regarding medical products. The interviews were used to draft and validate the interview guide for focus groups with patients with RA. Participants were purposively sampled in collaboration with the Swedish Rheumatism Association in Stockholm and Uppsala. Each focus group consisted of three to six patients (18 in total). All interviews were audio-recorded, transcribed verbatim, and analysed using content analysis.ResultsAccording to the participants, PPI could lead to regulators considering patients’ needs, lifestyles and well-being when making decisions. PPI was important in all stages of the medical product lifecycle. Participants reported that, when participating in a preference study, it is important to be well-informed about the use of the study and the development, components, administration, and risks related to the medical products.ConclusionsPatients thought PPI could be valuable to consider in regulatory decisions. It is essential for patients to be well-informed when asked for their preferences. Research on information materials to inform patients in preference studies is needed to increase the value of PPI in regulatory decision making.
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- Strömberg, Anna, 1967-, et al.
(författare)
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Psychometric Validation of the Heart Failure Caregiver Questionnaire (HF-CQ (R))
- 2017
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Ingår i: Patient. - : ADIS INT LTD. - 1178-1653 .- 1178-1661. ; 10:5, s. 579-592
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Tidskriftsartikel (refereegranskat)abstract
- Background The Heart Failure Caregiver Questionnaire (HF-CQ (R)) was developed to assess subjective outcomes of heart failure caregivers. The HF-CQ (R) comprises 21 questions on three domains, namely physical, emotional/psychological and lifestyle. The objective of this study was to evaluate the psychometric properties of the HF-CQ (R). Methods Patients (n = 150) with heart failure and their primary caregivers (n = 150) were recruited from 11 sites in USA. Caregivers completed the HF-CQ (R) and additional questionnaires, namely Caregiver Reaction Assessment, Work Productivity and Activity Impairment questionnaire, EuroQol-5 domain, and the Hospital Anxiety and Depression Scale. Patient-completed Global Impression of Severity, construct validity, concurrent validity, reliability and responsiveness of the HF-CQ (R) were also assessed. Results In the physical and lifestyle domains, all items showed acceptable validity. No high correlations between HF-CQ (R) scores and other caregiver-completed instruments, including the Hospital Anxiety and Depression Scale, Work Productivity and Activity Impairment questionnaire, EuroQol-5 domain or Caregiver Reaction Assessment, were reported. The intra-class correlation coefficient exceeded the threshold for reliability (amp;gt;0.7) across the physical well-being (0.785), emotional/psychological (0.797), lifestyle (0.787) and total scores (0.850), indicating acceptable reliability. Internal consistency results using Cronbachs alpha showed the total aggregate score of 0.942 to be reliable. In the responsiveness analyses, each of the three scales and the total score showed responsiveness to changes defined by the Caregiver Global Impression of Severity. The overall caregiver burden score increased with increased severity of illness in the cared-for patients. Conclusions The study provides initial evidence for the acceptable validity of the HF-CQ (R) as an instrument to measure heart failure caregiver burden.
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