Objectives: Patient-reported outcomes (PROs) are increasingly used in studies and medical practice to obtain information on patients' perspectives toward their treatment or disease. However, most study outcomes are primarily directed at healthcare professionals. It was aimed to obtain insight in which type of information immune-mediated inflammatory disease (IMID) patients prefer to receive after participating in the Dutch Biologic Monitor (DBM), a PRO-based prospective cohort event monitoring system focused on adverse drug reactions (ADRs). Methods: A survey was conducted among DBM participants that wanted information about the results. Patients' preferences were identified using twelve statements and rated with five-point Likert-type scales. Subgroup analyses and differences between statements were performed using Mann-Whitney U Tests. Results: The survey was completed by 591 patients (response rate 67.6%). Most respondents had inflammatory rheumatic diseases (76.8%) and used adalimumab (37.2%) or etanercept (33.2%). Respondents preferred results per IMID over aggregated results (p = <0.001). Information on whether patients with similar IMIDs experience ADRs (average 4.5), which biologics are most likely to cause ADRs (4.4) and whether ADRs disappear (4.4) were most interesting. Conclusion: DBM participants prefer to receive disease-specific information on ADRs that is tailored to their own biologic and IMID, including the outcome of ADRs.
Introduction To improve therapeutic decision making, it is crucial that information regarding adverse drug reactions reaches patients. It is not enough to disseminate such findings through regulatory and scientific channels; targeted efforts to reach patients are necessary. One possible avenue is to collaborate with patient organizations. Objectives The aim of this pilot study was to explore how adverse drug reactions can be communicated through patient organizations. Methods A text describing a signal of levothyroxine and panic attacks was tailored to patients’ needs, in terms of language, style and content, with emphasis placed on what to do when experiencing the symptoms described. The signal was communicated via the Dutch thyroid organization’s digital newsletter, social media channels, website and print magazine. Results The digital newsletter was distributed to around 5000 subscribers. On Facebook, 13,820 people viewed the message, with 2346 clicks in the message, indicating an intention to read the whole post. The interactions on social media were positive, and the tone was respectful. Conclusion Patient organizations can help enable effective communication of adverse drug reactions to a relevant audience. The social media post generated more engagement than other communications from the patient organization, indicating a strong interest in this information. The additional patient experiences that were shared in the comments on social media further strengthened the original signal and its relevance to patients, creating an interesting feedback loop. The favourable experiences in this study support further consideration and exploration of this approach to communicate adverse drug reactions to patients.
Background:Patient-reported outcomes (PROs) are increasingly used in studies and medical practice to obtain information on patients’ perspectives towards their treatment or disease. However, study outcomes are primarily directed at and shared with healthcare professionals, even though the results may also be relevant for patients.Objectives:The objective of this study was to obtain insight in which results patients with immune-mediated inflammatory diseases (IMIDs), including inflammatory rheumatic disease patients, prefer to receive after participating in the Dutch Biologic Monitor.Methods:The Dutch Biologic Monitor is a PRO-based prospective cohort event monitoring study focused on adverse drug reactions (ADRs) [1]. A survey was conducted among the participants of the Dutch Biologic Monitor who wanted to be informed about the results. Patients’ preferences were identified using twelve statements and rated with five-point Likert-type scales. Averages described the preference per statement. Preference for the results per IMID or altogether was assessed using Mann-Whitney U Test.Results:Respondents (N=591, response rate 67.6%) preferred results per IMID over aggregated results (p=<0.001). Information on whether patients with the same IMID experience ADRs (average 4.5), which biologics are most likely to cause ADRs (4.4) and whether the ADRs subside or disappear (4.4) were regarded as most interesting. Outcomes of patients with other IMIDs (3.5), patient characteristics (3.7) and injection site reactions (3.8) were least interesting.Table 1.Respondent characteristics.CharacteristicsAllInflammatory rheumatic disease patients(n=591)(%)(n=453)(%)Female gender,n(%)353(59.7)286(63.1)Age, median (IQR), years59.0(51.0-67.0)60.0(51.0-67.5)BiologicsAdalimumab220(37.2)164(36.2)Etanercept196(33.2)189(41.7)Infliximab43(7.3)8(1.8)Tocilizumab21(3.6)17(3.8)Ustekinumab21(3.6)7(1.5)Other90(15.2)68(15.0)Combination therapyMethotrexate195(33.0)183(40.4)Corticosteroids65(11.0)51(11.3)Thiopurines41(6.9)10(2.2)No combination therapy231(39.1)157(34.7)Other123(20.8)106(23.4)Indications for biologic therapyRheumatoid arthritis277(46.9)277(61.1)Psoriatic arthritis111(18.8)111(24.5)Ankylosing spondylitis/axSpA83(14.0)83(18.3)Other159(26.9)17(3.8)IQR: interquartile range; axSpA: axial spondyloarthritis.Figure 1.The preferences of patients on the communication of the reported adverse drug reaction information resulting from the Dutch Biologic Monitor.Conclusion:Participants of the Dutch Biologic Monitor that use a biologic for their IMID prefer to receive ADR information tailored to their own biologic and IMID. Furthermore, they want to obtain insight in the course of ADRs. Therefore, we advocate to generate disease-specific information on ADRs for IMID patients.References:[1]Kosse LJ, Jessurun NT, Hebing RCF, Huiskes VJB, Spijkers KM, van den Bemt BJF, et al. Patients with inflammatory rheumatic diseases: quality of self-reported medical information in a prospective cohort event monitoring system.Rheumatol.published on 30 Sept 2019. doi: 10.1093/rheumatology/kez412.Disclosure of Interests:Gerda Weits: None declared, Leanne Kosse: None declared, Harald Vonkeman: None declared, Phyllis Spuls Grant/research support from: Departmental independent research grant for TREAT NL registry LeoPharma December 2019; Contract support: I am involved in performing clinical trials with many pharmaceutical industries that manufacture drugs used for the treatment of e.g. psoriasis and atopic dermatitis for which we get financial compensation paid to the department/hospital, Consultant of: Consultancies in the past for Sanofi 111017 and AbbVie 041217 (unpaid), Bart van den Bemt Grant/research support from: UCB, Pfizer and Abbvie, Consultant of: Delivered consultancy work for UCB, Novartis and Pfizer, Speakers bureau: Pfizer, AbbVie, UCB, Biogen and Sandoz., Sander Tas: None declared, Frank Hoentjen Grant/research support from: Received grants from Dr Falk, Janssen-Cilag, and AbbVie., Consultant of: Served on advisory boards, or as speaker or consultant for AbbVie, Celgene, Janssen-Cilag, MSD, Takeda, Celltrion, Teva, Sandoz, and Dr Falk, Speakers bureau: Served on advisory boards, or as speaker or consultant for AbbVie, Celgene, Janssen-Cilag, MSD, Takeda, Celltrion, Teva, Sandoz, and Dr Falk, Michael Nurmohamed Grant/research support from: Not related to this research, Consultant of: Not related to this research, Speakers bureau: Not related to this research, Martijn van Doorn Grant/research support from: Unrestricted grants, advisory board, speaker fees and/or other (investigator) from Novartis, Abbvie, Janssen Cilag, Leopharma and Pfizer, Speakers bureau: Unrestricted grants, advisory board, speaker fees and/or other (investigator) from Novartis, Abbvie, Janssen Cilag, Leopharma and Pfizer, Eugène van Puijenbroek: None declared, Naomi Jessurun: None declared
Background:Patient-reported outcomes (PROs) on adverse drug reactions (ADRs) are increasingly used in cohort event monitoring (CEM) to obtain a better understanding of patient’s real-world experience with drugs. Despite the leading role for patients, little is known about their perspectives on these monitoring systems.Objectives:To obtain more insight in patients’ perspectives on the perceived usefulness, ease of use and attitude toward using the Dutch Biologic Monitor (DBM), and their preferred design for a national drug safety monitoring system for immune-mediated inflammatory diseases (IMIDs).Methods:We developed a cross-sectional open survey following the rationale of the Technology Acceptance Model to obtain insight in patients’ perspectives on the DBM. The DBM is a pilot for a PRO-based drug safety monitoring system focused on ADRs attributed to biologics that are prescribed for IMIDs. This survey consisted of 20 categorical and 1 open-ended question. Seven categorical questions contained a text field for additional comments. Five-point Likert-type scales or multiple-choice questions were used to identify patients’ preferences and perspectives. Patients were eligible for the survey if they were still enrolled in the DBM at the time of the survey opening and if they had completed at least one questionnaire of the DBM. Categorical questions were descriptively analyzed, whereas text fields were analyzed using theoretical thematic analysis.Results:At the start of the survey a total of 1,225 patients had participated in the DBM. Approximately 70% had an inflammatory rheumatic disease. The survey was completed by 292 eligible respondents (response rate 44.8%). The respondents generally agreed that it was useful to participate in the DBM and would recommend it to their peers (Figure 1). The response burden of the bimonthly questionnaires was scored as ‘low’, irrespective of the presence of ADRs or education level (Table 1). A number of respondents suggested that the questionnaire frequency should be synchronized with the regular hospital visits or the administration schedule of the biologic. Moreover, questionnaires should be offered less frequent and preferably shortened in case of an unaltered situation or absence of ADRs. Half (49.0%) of the respondents was interested in sharing their questionnaires with a medical specialist, whereas a third (34.2%) advocated sharing the questionnaires with their pharmacist (Figure 1).Table 1.Perceived response burden of the Dutch Biologic Monitor questionnaires. The average burden is calculated using a five-point Likert-type scale. Data is represented as the number of respondents (n).Overall(n = 292)ADRs reportedEducation levelaYes(n = 225)No(n = 54)Do not know(n = 13)Lower(n = 149)Higher(n = 139)Burdenn(%)n(%)n(%)n(%)n(%)n(%)1: No burden224(76.7)169(75.1)46(85.2)9(69.2)106(71.1)115(82.7)2: Low burden58(19.9)48(21.3)7(13.0)3(23.1)36(24.2)22(15.8)3: Moderate burden6(2.1)6(2.7)0(0.0)0(0.0)4(2.7)2(1.4)4: High burden0(0.0)0(0.0)0(0.0)0(0.0)0(0.0)0(0.0)5: Very high burden0(0.0)0(0.0)0(0.0)0(0.0)0(0.0)0(0.0)No opinion4(1.4)2(0.9)1(1.9)1(0.0)3(2.0)0(0.0)Average burden1.21.31.11.21.31.2aMissing: 4 respondents.Figure 1.Stacked bar graph of user perspectives. Agreement scores were measured using a five-point Likert-type scale. The average agreement score per statement is indicated on the far right. The percentages represent the share of respondents. DBM: Dutch Biologic Monitor; ADRs: adverse drug reactions.Conclusion:This study provides valuable insights in the patient perspective on a PRO-based drug safety monitoring system for inflammatory rheumatic diseases and other IMIDs, and provides several useful starting points to further stimulate and improve PRO-based CEM systems. Altogether, it appears feasible to establish a PRO-based drug safety monitoring system that monitors IMID patients’ real-world experience with ADRs that has a low burden for the participants.Disclosure of Interests:Leanne Kosse: None declared, Gerda Weits: None declared, Harald Vonkeman Grant/research support from: AbbVie, Amgen, AstraZeneca, BMS, Celgene, Celltrion, Galapagos, Gilead, GSK, Janssen-Cilag, Lilly, MSD, Novartis, Pfizer, Roche, Sanofi-Genzyme, all outside the submitted work., Sander Tas Grant/research support from: AbbVie, Arthrogen, AstraZeneca, BMS, Celgene, Galapagos, GSK, MSD, Pfizer, Roche, Sanofi-Genzyme, all outside the submitted work., Frank Hoentjen Speakers bureau: Abbvie, Janssen-Cilag, MSD, Takeda, Celltrion, Teva, Sandoz and Dr Falk, all outside the submitted work, Consultant of: Celgene, Janssen-Cilag, all outside the submitted work, Grant/research support from: Dr Falk, Janssen-Cilag, Abbvie, Takeda, all outside the submitted work, Martijn van Doorn Grant/research support from: Leopharma, Novartis, Abbvie, BMS, Celgene, Lilly, MSD, Pfizer, Sanofi-Genzyme, Janssen Cilag, outside the submitted work., Phyllis Spuls Grant/research support from: Departmental independent research grant for TREAT NL registry from different companies, is involved in performing clinical trials with many pharmaceutical industries that manufacture drugs used for the treatment of e.g. psoriasis and atopic dermatitis, for which financial compensation is paid to the department/hospital and, is Chief Investigator (CI) of the systemic and phototherapy atopic eczema registry (TREAT NL) for adults and children and one of the main investigators of the SECURE-AD registry, all outside the submitted work., Geert D’Haens Consultant of: Abbvie, Ablynx, Active Biotech AB, Agomab Therapeutics, Allergan, Alphabiomics, Amakem, Amgen, AM Pharma, Applied Molecular Therapeutics, Arena Pharmaceuticals, AstraZeneca, Avaxia, Biogen, Bristol Meiers Squibb/Celgene, Boehringer Ingelheim, Celltrion, Cosmo, DSM Pharma, Echo Pharmaceuticals, Eli Lilly, Engene, Exeliom Biosciences, Ferring, DrFALK Pharma, Galapagos, Genentech/Roche, Gilead, Glaxo Smith Kline, Gossamerbio, Pfizer, Immunic, Johnson and Johnson, Kintai Therapeutics, Lycera, Medimetrics, Takeda, Medtronic, Mitsubishi Pharma, Merck Sharp Dome, Mundipharma, Nextbiotics, Novonordisk, Otsuka, Photopill, ProciseDx, Prodigest, Prometheus laboratories/Nestle, Progenity, Protagonist, RedHill, Robarts Clinical Trials, Salix, Samsung Bioepis, Sandoz, Seres/Nestec/Nestle, Setpoint, Shire, Teva, Tigenix, Tillotts, Topivert, Versant and Vifor, all outside the submitted work, Michael Nurmohamed Speakers bureau: AbbVie, Celgene, Celltrion, Eli Lilly, Janssen, Sanofi, all outside the submitted work, Consultant of: AbbVie, Bristol-Myers Squibb, Eli Lilly, Roche, Sanofi, all outside the submitted work, Grant/research support from: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, MSD, Mundipharma, Novartis, Pfizer, Roche, Sanofi, all outside the submitted work, Eugène van Puijenbroek: None declared, Bart van den Bemt: None declared, Naomi Jessurun: None declared
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