A mixed methods protocol to investigate medication adherence in patients with rheumatoid arthritis of White British and South Asian origin.
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ABSTRACT: Background
Low adherence to medicines is an important issue as up to 40% of patients with chronic diseases do not take their medications as prescribed. This leads to suboptimal clinical benefit. In the context of rheumatoid arthritis, there is a dearth of data on adherence to disease-modifying antirheumatic drugs among minority ethnic groups. This study aims to assess the relationship between adherence to medicines and biopsychosocial variables in patients with rheumatoid arthritis of South Asian and White British origin.Methods/analysis
A mixed methods approach will be used, encompassing a cross-sectional survey of 176 patients collecting demographic and clinical data, including information on adherence behaviour collected using a series of questionnaires. This will be followed by indepth qualitative interviews.Ethics and dissemination
This study has been approved by the South Birmingham (10/H1207/89) and Coventry and Warwickshire (12/WM/0041) Research Ethics Committees. The authors will disseminate the findings in peer-reviewed publications.
SUBMITTER: Kumar K
PROVIDER: S-EPMC3586171 | biostudies-literature | 2013
REPOSITORIES: biostudies-literature
Publications
A mixed methods protocol to investigate medication adherence in patients with rheumatoid arthritis of White British and South Asian origin.
Kumar Kanta K Raza Karim K Nightingale Peter P Horne Rob R Shaw Karen K Greenfield Sheila S Gill Paramjit P
BMJ open 20130220 2
<h4>Background</h4>Low adherence to medicines is an important issue as up to 40% of patients with chronic diseases do not take their medications as prescribed. This leads to suboptimal clinical benefit. In the context of rheumatoid arthritis, there is a dearth of data on adherence to disease-modifying antirheumatic drugs among minority ethnic groups. This study aims to assess the relationship between adherence to medicines and biopsychosocial variables in patients with rheumatoid arthritis of So ...[more]
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Project description:For the optimum efficacy of disease-modifying anti-rheumatic drugs (DMARDs), patients need to be adherent to their medication regimen. To clarify the effects of medication adherence on disease activity in Japanese patients with rheumatoid arthritis (RA), we conducted a cohort study in patients with various stages of RA. Patients were enrolled from the Kyoto University RA Management Alliance cohort, and followed up prospectively for 12 months. In this study, a total of 475 patients were analyzed and divided into 9 groups according to their medication adherence and the RA disease duration. The primary outcomes were based on the rate of a disease flare. The secondary outcomes were the changes in disease activity score using 28 joints (DAS28-ESR), simplified disease activity index (SDAI) and physical disability by health assessment questionnaire-disability index (HAQ). The changes in DAS28-ESR, HAQ, and the risk of disease flare in the highly adherent patients were significantly lower than those of the less adherent patients among the groups with RA ? 4.6 years but not those among the other groups. Taken together, this study identified a significant association between medication adherence and the disease flare during early-stage RA or short disease duration. These results emphasize the need to pay more attention to medication adherence in preventing the disease progression of RA.
| S-EPMC6214559 | biostudies-other
Project description:Objective:The aim was to validate the Urdu version of General Medication Adherence Scale (GMAS) in patients with rheumatoid arthritis disease. Methods:A 2-month (March-April 2019) cross-sectional study was conducted in randomly selected out-patients with rheumatoid arthritis. The sample size was calculated using item-subject ratio of 1:20. The scale was evaluated for factorial, concrete, concurrent, and known group validities. Concrete validity was established by correlating scores of EQ-5D quality of life scale and GMAS adherence score. Concurrent validity was established by correlating the GMAS adherence score with pill count. Analyses for sensitivity were also conducted. Cut-off value was determined through receiver operator curve (ROC), and test-retest method was used to analyze internal consistency and reliability. Data were analyzed through IBM SPSS, IBM AMOS, and MedCalc software. The Urdu version of EQ-5D quality of life questionnaire was used with permission from developers (#ID20884). The study was approved by an ethics committee (#NOV:15). Results:A total of 351 responses were analyzed. The response rate was 98%. Reliability was in acceptable range, i.e., Cronbach ? = 0.797. Factorial validity was established by calculation of satisfactory fit indices. Correlation coefficients for concrete and concurrent validities were ? = 0.687, p < 0.01 and ? = 0.779, p < 0.01, respectively. Known group validity was established as significant association of adherence score with insurance and illness duration (p < 0.05) that were reported. Sensitivity of the scale was 94%. Most patients had high adherence (N = 159, 45.3%). Conclusion:The Urdu version of GMAS demonstrated adequate internal consistency and was validated. These results indicate that it is an appropriate tool to measure medication adherence in Pakistani patients with rheumatoid arthritis.
| S-EPMC7379482 | biostudies-literature
Project description:Hypoxia stimulates synovial hypoperfusion in rheumatoid arthritis (RA). TXNDC5 stimulates cellular proliferation in hypoxic conditions. We previously detected increased TXNDC5 expression in synovial tissues and blood from RA patients and demonstrated that the gene encoding TXNDC5 increased RA risk. The present study investigated the pathogenic roles of TXNDC5 in RA. Transgenic mice that over-expressed TXNDC5 (TXNDC5-Tg) were generated using C57BL/6J mice and treated with bovine collagen II to induce arthritis (CIA). Synovial fibroblasts from RA patients (RASFs) were cultured and incubated with TXNDC5-siRNA or CoCl(2), a chemical that induces hypoxia. CIA was observed in 80% of the TXNDC5-Tg, but only 20% of the wild-type mice (WT) developed CIA. The clinical arthritis scores reached 5 in the TXNDC5-Tg, but this index only reached 2 in the control mice. CIA TXNDC5-Tg exhibited clear pannus proliferation and bone erosion in joint tissues. A significant increase in CD4 T cells was observed in the thymus and spleen of TXNDC5-Tg during CIA. Serum levels of anti-collagen II IgG, IgG1 and IgG2a antibodies were significantly elevated in the mice. Increased cell proliferation, cell migration and TXNDC5 expression were observed in RASFs following incubation with 1 µM CoCl(2). However, this effect was diminished when TXNDC5 expression was inhibited with 100 nM siRNA. TNF-alpha, IL-1α, IL-1β and IL-17 levels were significantly increased in the blood of TXNDC5-Tg mice, but the levels of these cytokines declined in the supernatant of RASFs that were treated with TXNDC5 siRNA. The expression of adiponectin, a cytokine-like mediator, decreased significantly in RASFs following TXNDC5 siRNA treatment. These results suggest that TXNDC5-over-expressing mice were susceptible to CIA. This study also suggests that hypoxia induced TXCNDC5 expression, which contributed to adiponectin expression, cytokine production and the cellular proliferation and migration of fibroblasts in RA.
| S-EPMC3541148 | biostudies-literature
Project description:ObjectiveDisease activity of rheumatoid arthritis (RA) patients was often measured by the 28-joint count disease activity score (DAS-28), which consists of 28 swollen and tender joint counts, patient's assessment of disease activity (visual analog scale [VAS]) and erythrocyte sedimentation rate. C-reactive protein was also used to measure disease activity in RA patients. The aim was to explore the impact of medication adherence on disease activity in patients with RA.MethodsA systematic search was performed in major electronic databases (PubMed, Web of Science, the Cochrane Library, CNKI, VIP and Wan fang) to identify studies reporting medication adherence and disease activity in RA patients. Results were expressed as mean difference (MD) and 95% CI.ResultsA total of seven identified studies matched the inclusion criteria, reporting on a total of 1,963 adult RA patients in the analysis. The total score of DAS-28 was significantly lower in adherent patients than in nonadherent subjects (MD =-0.42, 95% CI [-0.80, -0.03], P=0.03). Similarly, a significant difference was observed between medication adherent and nonadherent groups in erythrocyte sedimentation rate (MD =-7.39, 95% CI [-11.69, -3.08], P<0.01) and tender joint count (MD =-1.29, 95% CI [-2.51, -0.06], P=0.04). Interestingly, the results of the meta-analysis showed no significant difference between medication adherent and nonadherent patients in swollen joint count (MD =-0.16, 95% CI [-2.13, 1.80], P=0.87), visual analog scale (MD =1.41, 95% CI [-3.68, 6.50], P=0.59) and C-reactive protein (MD =0.35, 95% CI [-0.64, 1.34], P=0.49).ConclusionThe study suggests that RA patients with higher medication adherence tended to have lower disease activity.
| S-EPMC5553350 | biostudies-literature
Project description:Introduction/objectivesAdherence to prescribed medication regimens is fundamental to the improvement and maintenance of the health of patients with rheumatoid arthritis. It is therefore important that interventions are developed to address this important health behavior issue. The aim of the present study was to design and evaluate a theory-based intervention to improve the medication adherence (primary outcome) among rheumatoid arthritis patients.MethodsThe study adopted a pre-registered randomized controlled trial design. Rheumatoid arthritis patients were recruited from two University teaching hospitals in Qazvin, Iran from June 2018 to May 2019 and randomly assigned to either an intervention group (n = 100) or a treatment-as-usual group (n = 100). The intervention group received a theory-based intervention designed based on the theoretical underpinnings of the health action process approach (HAPA). More specifically, action planning (making detailed plans to follow medication regimen), coping planning (constructing plans to overcome potential obstacles that may arise in medication adherence), and self-monitoring (using a calendar to record medication adherence) of the HAPA has been used for the treatment. The treatment-as-usual group received standard care.ResultsData analysis was conducted based on the principle of intention to treat. Using a linear mixed-effects model (adjusted for age, sex, medication prescribed, and body mass index), the results showed improved medication adherence scores in the intervention group (loss to follow-up = 16) compared to the treatment-as-usual group (loss to follow-up = 12) at the 3-month (coefficient = 3.9; SE = 0.8) and 6-month (coefficient = 4.5; SE = 0.8) follow-up. Intervention effects on medication adherence scores were found to be mediated by some of the theory-based HAPA variables that guided the study.ConclusionThe results of the present study support the use of a theory-based intervention for improving medication adherence among rheumatoid arthritis patients, a group at-risk of not adhering to medication regimens. TRIAL REGISTRATION (IN IRANIAN REGISTRY OF CLINICAL TRIALS): irct.ir, IRCT20180108038271N1 Key Points • Theoretical underpinnings of the health action process approach are useful to improve medication adherence for RA patients.
| S-EPMC7782392 | biostudies-literature
Project description:Many studies have investigated racial/ethnic disparities in medication non-adherence in patients with type 2 diabetes using common measures such as medication possession ratio (MPR) or gaps between refills. All these measures including MPR are quasi-continuous and bounded and their distribution is usually skewed. Analysis of such measures using traditional regression methods that model mean changes in the dependent variable may fail to provide a full picture about differential patterns in non-adherence between groups.A retrospective cohort of 11,272 veterans with type 2 diabetes was assembled from Veterans Administration datasets from April 1996 to May 2006. The main outcome measure was MPR with quantile cutoffs Q1-Q4 taking values of 0.4, 0.6, 0.8 and 0.9. Quantile-regression (QReg) was used to model the association between MPR and race/ethnicity after adjusting for covariates. Comparison was made with commonly used ordinary-least-squares (OLS) and generalized linear mixed models (GLMM).Quantile-regression showed that Non-Hispanic-Black (NHB) had statistically significantly lower MPR compared to Non-Hispanic-White (NHW) holding all other variables constant across all quantiles with estimates and p-values given as -3.4% (p = 0.11), -5.4% (p = 0.01), -3.1% (p = 0.001), and -2.00% (p = 0.001) for Q1 to Q4, respectively. Other racial/ethnic groups had lower adherence than NHW only in the lowest quantile (Q1) of about -6.3% (p = 0.003). In contrast, OLS and GLMM only showed differences in mean MPR between NHB and NHW while the mean MPR difference between other racial groups and NHW was not significant.Quantile regression is recommended for analysis of data that are heterogeneous such that the tails and the central location of the conditional distributions vary differently with the covariates. QReg provides a comprehensive view of the relationships between independent and dependent variables (i.e. not just centrally but also in the tails of the conditional distribution of the dependent variable). Indeed, without performing QReg at different quantiles, an investigator would have no way of assessing whether a difference in these relationships might exist.
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Project description:OBJECTIVES:To identify differences in the mutational profile of endometrial tumours between British White (BW) and South Asian (BSA) women. METHODS:We analysed primary tumours from matched cohorts of British White (BW) and British South Asian (BSA) women resident in Leicestershire diagnosed with EC. Next Generation Sequencing was performed to investigate mutational differences in a panel of 10 genes previously identified as being commonly mutated in EC. The presence of somatic Mismatch Repair (MMR) gene deficiencies was determined by immunohistochemistry. RESULTS:In total, 57 tumours (27 BSA and 30 BW) were sequenced. There was no significant difference in the overall mutation frequency of the 10 genes analysed; however, numerous differences were observed between the groups. There was a positive association between PIK3CA and PTEN mutations in the BSA group, with 78% of PIK3CA-mutant tumours harbouring a PTEN mutation, whereas only 11% of PIK3CA wild-type (wt) tumours were PTEN mutant positive (p = 0.0012). In BW women, 90% of ARID1A mutant tumours had co-existent PI3K pathway mutations versus 50% of wild-type (wt) ARID1A patients (p = 0.0485). This trend was not significant in the BSA group (p = 0.66). The age at diagnosis was significantly higher in the BW group with a somatic MMR gene deficiency compared to those with no deficiency (72.8 years versus 59.6 years, p = 0.007), whereas this difference was not seen in the BSA group (64 years versus 60 years, p = 0.37). CONCLUSION:We have identified differences in the mutational profile of primary EC tumours from BW and BSA women. Further research is needed to confirm these findings and to explore their potential implications for early detection, treatment response and prognosis.
| S-EPMC7286498 | biostudies-literature
Project description:ObjectivesSuboptimal medication adherence is a serious problem in the treatment of chronic inflammatory diseases. To measure medication adherence, electronic monitoring is regarded as superior to pill count. GLORIA is an ongoing two-year trial on the addition of low-dose (5 mg/d) prednisolone or placebo to standard care in older people (65+ years) with RA. During the entire trial, adherence is measured with electronic caps, and with pill counts. The objective is to describe medication adherence patterns, and to compare the adherence results of the two methods.MethodsThe recorded adherence patterns of patients (blinded for treatment group) were classified according to descriptive categories. The cutoff for good adherence was set at 80% of prescribed pills taken.ResultsTrial inclusion closed in 2018 at 451 patients, but trial follow-up is ongoing; the current dataset contains adherence data of 371 patients. Mean number of recorded 90-day periods per patient was 4 (range 1-8). Based on pill count over all periods, 90% of the patients had good adherence; based on cap data, only 20%. Cap data classified 30% of patients as non-user (<20% of days an opening) and 40% as irregular user (different adherence patterns, in or between periods).ConclusionIn our trial of older people with RA, the majority appeared to be adherent to medication according to pill count. Results from caps conflicted with those of pill counts, with patterns suggesting patients did not use the bottle for daily dispensing, despite specific advice to do so.Trial registrationNCT02585258. ClinicalTrials.gov (https://www.clinicaltrials.gov/).
| S-EPMC8566247 | biostudies-literature
Project description:BACKGROUND:The prevalence of type 2 diabetes (T2D) is greater in South Asian populations and health outcomes are poorer compared with other ethnic groups. British South Asians are up to six times more likely to have T2D than the general population, to develop the condition at a younger age, and to experience diabetes-related complications. Interventions to support people in managing their condition can potentially reduce debilitating complications. Evidence to support the use of digital devices in T2D management, including mobile phones, has shown positive impacts on glycemic control. There is increasing recognition that health interventions that are culturally adapted to the needs of specific groups are more likely to be relevant and acceptable, but evidence to support the effectiveness of adapted interventions is limited and inconclusive. OBJECTIVE:This formative study aimed to explore the perceptions and views of British South Asian patients with T2D on mobile health SMS text messaging to support medication adherence, aimed at the general UK population. METHODS:Eight exploratory focus groups were conducted in Leicester, the United Kingdom, between September 2017 and March 2018. A diverse sample of 67 adults took part. RESULTS:British South Asian people with T2D who use digital devices, including mobile phones, felt that short messages to support medication adherence would be acceptable and relevant, but they also wanted messages that would support other aspects of self-management too. Participants were particularly interested in content that met their information needs, including information about South Asian foods, commonly used herbs and spices, natural and herbal approaches used in the United Kingdom and in South Asia, and religious fasting. Short messages delivered in English were perceived to be acceptable, often because family members could translate for those unable to read or understand the messages. Suggestions to support patients unable to understand short messages in English included having them available in different formats, and disseminated in face-to-face groups for those who did not use digital devices. CONCLUSIONS:Exploring the views of British South Asian patients about SMS text messaging aimed at the general UK population is important in maximizing the potential of such an intervention. For such a digital system to meet the needs of UK South Asian populations, it may also have to include culturally relevant messages sent to those who opt to receive them. It is equally important to consider how to disseminate message content to patients who do not use digital devices to help reduce health inequalities.
| S-EPMC7199132 | biostudies-literature
Project description:IntroductionThis study evaluated 12 months adherence and persistence among Janus kinase inhibitors (upadacitinib, baricitinib, tofacitinib) and adalimumab, a tumor necrosis factor inhibitor (TNFi), in patients with rheumatoid arthritis (RA).MethodsThis retrospective analysis used administrative claims data from the Merative™ MarketScan® Research Databases (2018-2022). Eligible adults had ≥ 1 RA diagnosis before the index date, ≥ 1 pharmacy claim for index medication, and ≥ 12 months of continuous insurance enrollment pre- and post-index. Adherence to treatment [defined as proportion of days covered (PDC) ≥ 80%], risk of treatment discontinuation, and mean time to discontinuation were assessed during the 12 months follow-up. Adjusted odds ratios (aOR), adjusted hazard ratios (aHR), and 95% confidence intervals (CI) were reported.ResultsIn total, 6317 patients were included (683 upadacitinib, 3732 adalimumab, 132 baricitinib, 1770 tofacitinib). Compared with upadacitinib, patients initiating adalimumab [aOR (95% CI): 0.82 (0.69, 0.96)], baricitinib [0.46 (0.31, 0.68)], and tofacitinib [0.74 (0.62, 0.88)] were significantly less likely to achieve PDC ≥ 80%. Risk of treatment discontinuation was significantly higher in patients treated with adalimumab [aHR (95% CI): 1.14 (1.01, 1.29)], baricitinib [1.48 (1.16, 1.90)], and tofacitinib [1.22 (1.07, 1.38)] compared with upadacitinib. Mean time to discontinuation was 256 (upadacitinib), 249 (adalimumab), 221 (baricitinib), and 239 (tofacitinib) days. Similar results were observed in patients with prior TNFi use.ConclusionsPatients with RA, regardless of recent TNFi experience, initiating upadacitinib were significantly more likely to be adherent and less likely to discontinue therapy compared to adalimumab, baricitinib, and tofacitinib in the first 12 months of treatment.
| S-EPMC10499920 | biostudies-literature