Effect of a smart temperature logger on correctly storing biological disease-modifying antirheumatic drugs at home: a pre-post study.

OBJECTIVES: Biological disease-modifying antirheumatic drugs (bDMARDs) require specific storage temperatures, but are frequently stored outside the recommended range of 2-8°C. As incorrect storage may affect therapy effectiveness and consequently lead to higher disease activity, compliance with recommended storage temperatures should be improved. eHealth interventions can provide insight into storage temperatures and alerts in case of deviations from recommended temperatures. Therefore, this study aims to assess the effect of a smart temperature logger on correctly storing bDMARDs at home by patients with rheumatic diseases. METHODS: A pre-post study was performed in a hospital in the Netherlands. The baseline period consisted of 12 weeks of storage temperature measurement with a passive temperature logger, and the intervention period consisted of 12 weeks of storage temperature measurement with a smart temperature logger. This smart logger included a smartphone application which provided insight into storage temperatures and real-time alerts when exceeding recommended temperatures. The main outcome measure was the difference in the number of patients who stored their bDMARDs correctly between baseline and intervention. Secondary outcomes were the difference in the proportion of measurement time within 2-8°C between baseline and intervention, the distribution of measurement time among temperature categories, and the patient's acceptance measured using a questionnaire based on the Technology Acceptance Model. RESULTS: In total, 48 participants (median age 55 years (IQR 47-64), 53% male) were analysed. The proportion of participants correctly storing bDMARDs increased from 18.8% (n=9) during baseline to 39.6% (n=19) during intervention (p=0.004). The median proportion of measurement time between 2-8°C improved by 6% (IQR 0-34%) (p<0.0001). Technology acceptance was scored as moderate. CONCLUSIONS: Temperature monitoring and real-time feedback with a smart temperature logger shows potential to improve at-home storage of bDMARDs, provided that continuous connection is realised to ensure real-time alerts and data collection.

Factors Influencing Preferences of Patients With Rheumatic Diseases Regarding Telehealth Channels for Support With Medication Use: Qualitative Study.

BACKGROUND: Patients with rheumatic diseases are known to experience drug-related problems at various times during their treatment. As these problems can negatively influence patients' health, they should be prevented or resolved as soon as possible, for which patients might benefit from additional support. Telehealth has the potential to continuously provide information and offers the possibility to easily contact a health care provider in order to support patients with medication use. Knowledge of factors influencing the patient's preference for telehealth channels can improve the actual use of telehealth channels. OBJECTIVE: This study aims to identify factors that influence the preferences of patients with rheumatic diseases regarding telehealth channels for support with medication use. METHODS: A qualitative study with face-to-face interviews was performed among patients with an inflammatory rheumatic disease in the Netherlands. A total of 4 telehealth channels were used: a frequently asked questions page, a digital human, an app for SMS text messaging with health care providers, and an app for video-calling with health care providers. Using a semistructured interview guide based on domains of the Capability, Opportunity, Motivation, and Behavior (COM-B) model, participants were questioned about (1) their general opinion on the 4 telehealth channels, (2) factors influencing preference for individual telehealth channels, and (3) factors influencing preference for individual telehealth channels in relation to the other available channels. Interviews were recorded, transcribed, and categorically analyzed. RESULTS: A total of 15 patients were interviewed (female: n=8, 53%; male: n=7, 47%; mean age 55, SD 16.8 years; median treatment duration of 41, IQR 12-106 months). The following 3 categories of factors influencing patient preference regarding telehealth channels were identified: (1) problem-related factors included problems needing a visual check, problems specifically related to the patient, and urgency of the problem; (2) patient-related factors included personal communication preference and patient characteristics; and (3) channel-related factors included familiarity with the telehealth channel, direct communication with a health care provider, methods of searching, and conversation history. CONCLUSIONS: Preference for telehealth channels is influenced by factors related to the problem experienced, the patient experiencing the problem, and telehealth channel characteristics. As the preference for telehealth channels varies between these categories, multiple telehealth channels should be offered to enable patients to tailor the support with their medication use to their needs.

Drug-related problems reported by patients with rheumatic diseases: an observational study.

BACKGROUND: Drug-related problems can negatively influence treatment outcome and well-being for patients with rheumatic diseases. Thus, it is important to support patients in preventing or resolving drug-related problems as quickly as possible. To effectively develop interventions for this purpose, knowledge on the frequency and character of drug-related problems is needed. Therefore, this study aims to quantify and characterize drug-related problems reported by patients with inflammatory rheumatic diseases along their treatment process. METHODS: A prospective observational study was conducted in a Dutch outpatient pharmacy. Adult patients with rheumatic diseases that were prescribed medication by a rheumatologist were questioned about experienced DRPs by telephone 4 times in 8 weeks using a structured interview-guide. Patient-reported DRPs were scored on uniqueness (i.e., if a specific DRP was reported in multiple interviews by one individual, this was counted as one unique DRP) and were categorized using a classification for patient-reported DRPs and analysed descriptively. RESULTS: In total, 52 participants (median age 68 years (interquartile range (IQR) 62-74), 52% male) completed 192 interviews with 45 (87%) participants completing all 4 interviews. The majority of patients (65%) were diagnosed with rheumatoid arthritis. Patients reported a median number of 3 (IQR 2-5) unique DRPs during interview 1. In subsequent interviews, patients reported median numbers of 1 (IQR 0-2), 1 (IQR 0-2) and 0 (IQR 0-1) unique DRPs for interviews 2-4 respectively. Participants reported a median number of 5 (IQR 3-9) unique DRPs over all completed interviews. Unique patient-reported DRPs were most frequently categorized into (suspected) side effects (28%), medication management (e.g., medication administering or adherence) (26%), medication concerns (e.g., concerns regarding long-term side-effects or effectiveness) (19%) and medication effectiveness (17%). CONCLUSIONS: Patients with rheumatic diseases report various unique DRPs with intervals as short as two weeks. These patients might therefore benefit from more continuous support in-between contact moments with their healthcare provider.

The value of incorporating patient-consulted medication reconciliation in influencing drug-related actions in the outpatient rheumatology setting.

BACKGROUND: Unintentional changes to patients' medicine regimens and drug non-adherence are discovered by medication reconciliation. High numbers of outpatient visits and medication reconciliation being time-consuming, make it challenging to perform medication reconciliation for all outpatients. Therefore, we aimed to get insight into the proportion of outpatient visits in which information obtained with medication reconciliation led to additional drug-related actions. METHODS: In October and November 2018, we performed a cross-sectional observational study at the rheumatology outpatient clinic. Based on a standardized data collection form, outpatient visits were observed by a pharmacy technician trained to observe and report all drug-related actions made by the rheumatologist. Afterwards, the nine observed rheumatologists and an expert panel, consisting of two rheumatologists and two pharmacists, were individually asked which drug information reported on the drug list composed by medication reconciliation was required to perform the drug-related actions. The four members of the expert panel discussed until consensus was reached about their assessment of the required information. Subsequently, a researcher determined if the required information was available in digital sources: electronic medical record (electronic prescribing system plus physician's medical notes) or Dutch Nationwide Medication Record System. RESULTS: Of the 114 selected patients, 83 (73%) patients were included. If both digital drug sources were available, patient's input during medication reconciliation resulted in additional information to perform drug-related actions according to the rheumatologist in 0% of the visits and according to the expert panel in 14%. If there was only access to the electronic medical record, the proportions were 8 and 29%, respectively. Patient's input was especially required for starting a new drug and discussing drug-related problems. CONCLUSIONS: If rheumatologists only had access to the electronic medical record, in 1 out of 3 visits the patient provided additional information during medication reconciliation which was required to perform a drug-related action. When rheumatologists had access to two digital sources, patient's additional input during medication reconciliation was at most 14%. As the added value of patient's input was highest when rheumatologists prescribe a new drug and/or discuss a drug-related problem, it may be considered that rheumatologists only perform medication reconciliation during the visit when performing one of these actions.

Usability and perceived usefulness of patient-centered medication reconciliation using a personalized health record: a multicenter cross-sectional study.

BACKGROUND: Adoption of a personal health record (PHR) depends on its usability and perceived usefulness. Therefore, we aimed to assess the usability and perceived usefulness of an online PHR used for medication reconciliation and to assess the association between patient-, clinical-, hospital-, and ICT-related factors and the usability and perceived usefulness at both the in- and outpatient clinics. METHODS: A multicenter cross-sectional study was conducted with patients with either an outpatient visit (rheumatology ward) or planned admission in the hospital (cardiology, neurology, internal medicine or pulmonary wards). All patients received an invitation to update their medication list in the PHR 2 weeks prior to their appointment. One month after the hospital visit, PHR-users were asked to rate usability (using the System Usability Scale (SUS)) and perceived usefulness on a 5-point Likert scale. The usability and perceived usefulness were classified according to the adjective rating scale of Bangor et al. The usability was furthermore dichotomized in the categories: low (SUS between 0 and 51) and good (SUS 51-100) usability. Associations between patient-, clinical-, hospital-, and ICT-related factors and the usability and perceived usefulness were analysed. RESULTS: 255 of the 743 invited PHR-users completed the questionnaire. 78% inpatients and 83% outpatients indicated that usability of the PHR was good. There were no significant association between patient-, clinical-, hospital-, and ICT-related factors and the usability of the PHR. The majority of the patients (57% inpatients and 67% outpatients) classified perceived usefulness of the PHR as good, excellent, or best imaginable. Outpatients who also used the PHR for other drug related purposes reported a higher perceived usefulness (adjusted odds ratio 20.0; 95% confidence interval 2.36-170). Besides that, there was no significant association between patient-, clinical-, hospital-, and ICT-related factors and the perceived usefulness of the PHR. CONCLUSIONS: The majority of the patients indicated that the PHR for medication reconciliation was useful and easy to use, but there is still room for improvement. To improve the intervention, further research should explore patients' barriers and facilitators of using a PHR for medication reconciliation.

Barriers and facilitators for the usage of a personal health record for medication reconciliation: A qualitative study among patients.

AIMS: Personal health records (PHRs) are more often used for medication reconciliation (MR). However, patients' adoption rate is low. We aimed to provide insight into patients' barriers and facilitators for the usage of a PHR for MR prior to an in- or outpatient visit. METHODS: A qualitative study was conducted among PHR users and non-users who had a planned visit at the outpatient rheumatology department or the inpatient cardiology or neurology department. About 1 week after the hospital visit, patients were interviewed about barriers and facilitators for the usage of a PHR for MR using a semi-structured interview guide based on the theoretical domains framework. Afterwards, data were analysed following thematic analysis. RESULTS: Ten PHR users and non-users were interviewed. Barriers and facilitators were classified in four domains: patient, application, process and context. We identified 14 barriers including limited (health) literacy and/or computer skills, practical and technical issues, ambiguity about who is responsible (the patient or the healthcare provider) and lack of data exchange and connectivity between applications. Besides that, ten facilitators were identified including being place and time independent, improve usability, target patients who benefit most and/or have sufficient skills, and integration of different applications. CONCLUSION: Barriers and facilitators identified at the patient, application, process and context level, need to be addressed to effectively develop and implement PHRs for MR.

Risk factors for clinically relevant deviations in patients' medication lists reported by patients in personal health records: a prospective cohort study in a hospital setting.

Background Personal health records have the potential to identify medication discrepancies. Although they facilitate patient empowerment and broad implementation of medication reconciliation, more medication discrepancies are identified through medication reconciliation performed by healthcare professionals. Aim We aimed to identify the factors associated with the occurrence of a clinically relevant deviation in a patient's medication list based on a personal health record (used by patients) compared to medication reconciliation performed by a healthcare professional. Method Three- to 14 days prior to a planned admission to the Cardiology-, Internal Medicine- or Neurology Departments, at Amphia Hospital, Breda, the Netherlands, patients were invited to update their medication file in their personal health records. At admission, medication reconciliation was performed by a pharmacy technician. Deviations were determined as differences between these medication lists. Associations between patient-, setting-, and medication-related factors, and the occurrence of a clinically relevant deviation (National Coordinating Council for Medication Error Reporting and Prevention class [Formula: see text] E) were analysed. Results Of the 488 patients approached, 155 patients were included. Twenty-four clinically relevant deviations were observed. Younger patients (adjusted odds ratio (aOR) 0.94; 95%CI:0.91-0.98), patients who used individual multi-dose packaging (aOR 14.87; 95%CI:2.02-110), and patients who used [Formula: see text] 8 different medications, were at highest risk for the occurrence of a clinically relevant deviation (sensitivity 0.71; specificity 0.62; area under the curve 0.64 95%CI:0.52-0.76). Conclusion Medication reconciliation is the preferred method to identify medication discrepancies for patients with individual multi-dose packaging, and patients who used eight or more different medications.

A comparison between medication reconciliation by a pharmacy technician and the use of an online personal health record by patients for identifying medication discrepancies in patients' drug lists prior to elective admissions.

AIM: Medication discrepancies (MDs), defined as unexplained differences among medication regimens, cause important public health problems with clinical and economic consequences. Medication reconciliation (MR) reduces the risk of MDs, but is time consuming and its success relies on the quality of different information sources. Online personalized health records (PHRs) may overcome these drawbacks. Therefore, the aim of this study is to determine the level of agreement of identified MDs between traditional MR and an online PHR and the correctness of the identified MDs with a PHR. METHODS: A prospective cohort study was conducted at the cardiology, neurology, internal medicine and pulmonary department of the Amphia Hospital, the Netherlands. Two weeks prior to a planned admission all patients received an invitation from a PHR to update their medication file derived from the Nationwide Medication Record System (NMRS). At admission MR was performed with all by a pharmacy technician, who created the best possible medication history (BPMH) based on the NMRS data and an interview. MDs were determined as discrepancies between the available information from the NMRS and the input and alterations patients or pharmacy technician made. The number, correctness of patients' alterations, type and severity of identified MDs were analysed. RESULTS: Of 488 patients approached, 155 (31.8 %) patients who both used the PHR and had received MR were included. The mean number of MDs identified with MR and PHR was 6.2 (SD 4.3) and 4.7 (SD 3.7), respectively. 82.1 % of the drug information noted by the patient in the PHR was correct compared to the BPMH and 98.6 % had no clinically relevant differences between the lists. CONCLUSION: Patients who used an online PHR can relatively accurately record a list of their medication. Further research is required to explore the level of agreement and the correctness of a PHR in other (larger) hospital(departments).

Association between healthcare practitioners' beliefs about statins and patients' beliefs and adherence.

AIMS: Adherence to statins ranges from 32% to 79%. Patients' beliefs about medication are associated with adherence. There is lack of insight into the possible association between beliefs of healthcare practitioners (HCPs) about statins and patients' beliefs and adherence. This study aims to examine whether HCPs' beliefs about statins are associated with patients' beliefs and adherence about/to statins. METHODS: Cross-sectional study in 48 pharmacies and affiliated physicians' practices between 3 September 2014 and 20 March 2015. HCPs' (prescribers and pharmacy staff) and patients' beliefs about statins were assessed with the Beliefs about Medicine Questionnaire (BMQ) specific. Adherence to statins was assessed with the MARS-5 questionnaire. Multilevel regression analysis was performed to assess the association between HCPs' beliefs and patients' beliefs and adherence. RESULTS: 1504 patients (mean age 66.8 [s.d. ± 9.9] years, 46.5% female) and 734 HCPs (209 physicians, 118 pharmacists and 366 pharmacy technicians) participated in this study. Patients have higher BMQ necessity (16.9 [s.d. ± 4.3]) and BMQ concern (12.3 [s.d. ± 3.9]) scores than HCPs (15.0 [s.d. ± 3.0] and 11.5 [s.d. ± 2.9], P < 0.001). No associations were found between any of the HCPs' BMQ and patients' BMQ scores and adherence to statins. Patients' BMQ necessity, concern and necessity-concerns (NC)-differential scores were associated with patients' adherence (MARS-5) scores. B (95% CI) coefficients were 0.057 (0.035-0.079), -0.040 (-0.064 to -0.016) and.061 (0.043-0.079). CONCLUSIONS: Patients have stronger beliefs about medication compared to HCPs. No associations were found between HCPs' BMQ scores on the one hand and patients' BMQ scores and adherence to statins on the other hand.

Communication about Drug-Related Problems (DRPs) during Patients' Visits to Dutch Physicians and Pharmacies.

The objective of this study is to assess the frequency and type of drug-related problems (DRPs) (1) raised and discussed (2) raised but not discussed or (3) not raised during patients' visits to healthcare practitioners (HCPs). In this cross-sectional study in Dutch outpatient clinics, GP practices and pharmacies, verbal cues from patients and HCPs indicating DRPs were inventoried by an observer during visits. It was also observed whether raised DRPs were discussed between patient and HCP. Post-encounter interviews (HCPs) were conducted and post-encounter questionnaires (patient) were distributed to identify DRPs not raised. In total, 431 patients were observed during a single visit. In 42.2% of these visits, 311 DRPs were raised (weighted mean (SD) 0.7 (±1.1) DRP/patient). Of these 311 DRPs, 82.0% were discussed between HCP and patient. HCPs did not raise existing DRPs in 3.9% of the 431 visits; in 6.3% of the 176 questionnaires the patient reported an existing DRP that had not been raised. In conclusion, almost one in six of the DRPs raised during visits are not discussed between HCP and patient. Furthermore, existing DRPs are not even raised in 4-6% of the visits. HCPs and patients should be aware that, although patients often have DRPs, these are not always discussed or not even raised during patients' visits.

Patients with inflammatory rheumatic diseases: quality of self-reported medical information in a prospective cohort event monitoring system.

OBJECTIVES: Assessment of the quality of patient-reported medical information in the Dutch Biologic Monitor and evaluation of the representativeness of the sampled participants. METHODS: Consecutive adult patients using a biologic DMARD (bDMARD) for an immune-mediated inflammatory disease were included in eight Dutch centres. For this substudy, data of 550 patients with inflammatory rheumatic diseases were used. Patient-reported bDMARD prescription, indication and combination therapy were verified for patients that permitted access to their electronic health record using percentage agreement and/or Cohen's kappa (n = 483). Conservative post hoc sensitivity analysis was performed to account for missing data. Population representativeness was tested for the entire substudy population by comparing age, gender and prescribed bDMARD to the centres' reference populations using Mann-Whitney U-test, χ2 goodness-of-fit or Fisher's exact test with Monte Carlo simulation (n = 550). RESULTS: The correct bDMARD was reported by 95.8% of the participants. Agreement between patients and electronic health record was almost perfect for indications (κ = 0.832) and substantial for combination therapies (κ = 0.725). Agreement on combination therapies remained substantial after post hoc sensitivity analysis (κ = 0.640). Gender distribution (P > 0.05) and bDMARD use (P > 0.05) were similar to the reference populations. Median age was different (58.0 vs 56.0 years, P = 0.04), but considered clinically irrelevant. CONCLUSION: The Dutch Biologic Monitor seems to be a valid tool to obtain patient-reported medical information. Reported medical information generally corresponded to the electronic health records and the participants represented their reference populations regarding age, gender and prescribed bDMARD.

Open-Label, Non-Mandatory Transitioning From Originator Etanercept to Biosimilar SB4: Six-Month Results From a Controlled Cohort Study.

OBJECTIVE: To evaluate the effects of non-mandatory transitioning from the originator biologic drug etanercept (ETN) to its biosimilar, SB4, on drug survival and effectiveness in a controlled cohort study of patients with an inflammatory rheumatic disease. METHODS: In 2016, 642 patients were asked to transition their treatment from originator ETN to biosimilar SB4 by a structured communication strategy with opt-out option. Patients who consented to switch to SB4 were considered eligible for inclusion in the transition cohort, while patients being treated with originator ETN in 2014 were recruited as the historical cohort. Drug survival was compared between the 2 cohorts using Cox regression analyses, which were adjusted for age, sex, diagnosis, ETN treatment duration, ETN dose interval, conventional synthetic disease-modifying antirheumatic drug usage, and C-reactive protein (CRP) level, with a robust variance estimator applied to account for repeated subjects (i.e., patients who were included in both the transition cohort and the historical cohort). Adjusted differences in the 6-month change in CRP level, Disease Activity Score in 28 joints using CRP level (DAS28-CRP), and Bath Ankylosing Spondylitis Disease Activity Index were also assessed. RESULTS: Of the 642 ETN-treated patients, 635 (99%) agreed to transition from originator ETN to biosimilar SB4, of whom 625 patients (433 with rheumatoid arthritis, 128 with psoriatic arthritis, and 64 with ankylosing spondylitis) were included in the transition cohort, and 600 ETN-treated patients from 2014 were included in the historical cohort. The crude treatment persistence rate for biosimilar SB4 over 6 months was 90% (95% confidence interval [95% CI] 88-93%), compared to a 6-month treatment persistence rate of 92% (95% CI 90-94%) for originator ETN. Patients in the transition cohort, compared to the historical cohort, had a statistically significantly higher relative risk of treatment discontinuation (adjusted hazard ratio 1.57, 95% CI 1.05-2.36) and showed smaller decreases in the CRP level (adjusted difference 1.8, 95% CI 0.3-3.2) and DAS28-CRP (adjusted difference 0.15, 95% CI 0.05-0.25) over 6 months. CONCLUSION: Non-mandatory transitioning from originator ETN to biosimilar SB4 using a specifically designed communication strategy resulted in a slightly lower 6-month treatment persistence rate and smaller decreases in disease activity in the transition cohort compared to the historical cohort, but these differences were not considered clinically relevant.

Higher de novo synthesized fatty acids and lower omega3- and omega6-long-chain polyunsaturated fatty acids in umbilical vessels of women with preeclampsia and high fish intakes.

Umbilical veins (UV) and arteries (UA) of preeclamptic women in Curaçao harbor lower long-chain polyunsaturated fatty acids (LCP). The present aim was to test these findings in Mwanza (Tanzania), whose inhabitants have high LCPomega3 and LCPomega6 intakes from Lake Victoria fish. Women with preeclampsia (n=28) in Mwanza had lower PUFA and higher 20:0 in UV and UA, compared with normotensive/non-proteinuric controls (n=31). Their UV 22:6omega3, 22:4omega6, LCPomega6, omega6, and LCPomega3+omega6 were lower, while saturated FA, potentially de novo synthesized FA (Sigmade novo) and (Sigmade novo)/(LCPomega3+omega6) ratio were higher. Their UA had higher 16:1omega7, omega7, 18:0, and 16:1omega7/16:0. Umbilical vessels in Mwanza had higher 22:6omega3, LCPomega3, omega3, and 16:0, and lower 22:5omega6, 20:2omega6, 18:1omega9, and omega9, compared to those in Curaçao. Preeclampsia in both Mwanza and Curaçao is characterized by lower LCP and higher Sigmade novo. An explanation of this might be placental dysfunction, while the similarity of umbilical vessel FA-abnormalities in preeclamptic and diabetic pregnancies suggests insulin resistance as a common denominator.