METHODS: Study within a trial of an international parallel group randomized controlled trial (RCT) that compares spironolactone to placebo. Adults receiving dialysis enter an 8-week active run-in period with spironolactone. Adherence was assessed by both self-report and pill counts in a subgroup of participants at both 3 weeks and 7 weeks.
RESULTS: 332 participants entered the run-in period of which 166 had complete data. By self-report, 146/166 (94.0%) and 153/166 (92.2%) had at least 80% adherence at 3 and 7 weeks respectively (kappa = 0.27 (95% C.I. 0.16 to 0.38). By pill counts, the mean (SD) adherence was 96.5% (16.1%) and 92.4% (18.2%) at 3 and 7 weeks respectively (r = 0.32) with a mean (SD) difference of 3.1% (17.8%) and a 95% limit of agreement from -31.7% to +37.9%. The proportion of adherent participants by self-report and pill counts at 3 weeks agreed in 87.4% of participants (McNemar's p-value 0.58, kappa 0.11, p = 0.02) and at 7 weeks agreed in 92.2% (McNemar's p-value 0.82, kappa 0.47, p
OBJECTIVE: With the growing body of evidence supporting the use of eHealth interventions, the intention is to conduct a meta-analysis on various health outcomes of eHealth interventions among ischaemic heart disease (IHD) patients.
METHODS: Based on PRISMA guidelines, eligible studies were searched through databases of Web of Science, Scopus, PubMed, EBSCOHost, and SAGE (PROSPERO registration CRD42021290091). Inclusion criteria were English language and randomised controlled trials published between 2011 to 2021 exploring health outcomes that empower IHD patients with eHealth interventions. RevMan 5.4 was utilised for meta-analysis, sensitivity analysis, and risk of bias (RoB) assessment while GRADE software for generating findings of physical health outcomes. Non-physical health outcomes were analysed using SWiM (synthesis without meta-analysis) method.
RESULTS: This review included 10 studies, whereby, six studies with 895 participants' data were pooled for physical health outcomes. Overall, the RoB varied significantly across domains, with the majority was low risks, a substantial proportion of high risks and a sizeable proportion of unclear. With GRADE evidence of moderate to high quality, eHealth interventions improved low density lipoprotien (LDL) levels in IHD patients when compared to usual care after 12 months of interventions (SMD -0.26, 95% CI [-0.45, -0.06], I2 = 0%, p = 0.01). Significance appraisal in each domain of the non-physical health outcomes found significant findings for medication adherence, physical activity and dietary behaviour, while half of the non-significant findings were found for other behavioural outcomes, psychological and quality of life.
CONCLUSIONS: Electronic Health interventions are found effective at lowering LDL cholesterol in long-term but benefits remain inconclusive for other physical and non-physical health outcomes for IHD patients. Integrating sustainable patient empowerment strategies with the advancement of eHealth interventions by utilising appropriate frameworks is recommended for future research.
OBJECTIVE: To investigate the impact of customized CMI (C-CMI) on health-related quality of life (HRQoL) among type 2 diabetes mellitus (T2DM) patients in Qatar.
METHODS: This was a randomized controlled intervention study, in which the intervention group patients received C-CMI and the control group patients received usual care. HRQoL was measured using the EQ-5D-5L questionnaire and EQ visual analog scale (EQ-VAS) at three intervals [i.e. baseline, after 3 months and 6 months].
RESULTS: The EQ-5D-5L index value for the intervention group exhibited sustained improvement from baseline to the third visit. There was a statistically significant difference between groups in the HRQoL utility value (represented as EQ index) at 6 months (0.939 vs. 0.796; p = 0.019). Similarly, the intervention group compared with the control group had significantly greater EQ-VAS at 6 months (90% vs. 80%; p = 0.003).
CONCLUSIONS: The impact of C-CMI on health outcomes of T2DM patients in Qatar reported improvement in HRQoL indicators among the intervention patients. The study built a platform for health policymakers and regulatory agencies to consider the provision of C-CMI in multiple languages.
METHODS/DESIGN: This is a randomized, single-blind, two-arm, controlled trial in patients with rheumatoid arthritis visiting outpatient rheumatology clinics in Karachi, Pakistan. We will enroll patients with established diagnosis of rheumatoid arthritis over 3 months. The patients would be randomized through a computer-generated list into the control group, i.e., usual care or into the intervention group, i.e., pharmaceutical care, in a ratio of 1:1, after providing signed written consent. The study will take place in two patient-visits over the course of 3 months. Patients in the intervention group would receive intervention from the pharmacist while those in the control group will receive usual care. Primary outcomes include change in mean score from baseline (week 0) and at follow up (week 12) in disease knowledge, adherence to medications and rehabilitation/physical therapy. The secondary outcomes include change in the mean direct cost of treatment, HRQoL and patient satisfaction with pharmacist counselling.
DISCUSSION: This is a novel study that evaluates the role of the pharmacist in improving treatment outcomes in patients with rheumatoid arthritis. The results of this trial could set the foundation for future delivery of care for this patient population in Pakistan. The results of this trial would be published in a peer-reviewed journal.
TRIAL REGISTRATION: ClinicalTrials.gov, NCT03827148 . Registered on February 2019.
METHODS: 71 patients from 18 facilities participated in the 8-week single-arm intervention study. GRVOTS mobile apps were installed in their mobile apps, and patients were expected to fulfill tasks such as providing Video Direct Observe Therapy (VDOTS) daily as well as side effect reporting. At 3-time intervals of baseline,1-month, and 2-month intervals, the number of VDOT taken, the Malaysian Medication Adherence Assessment Tool (MyMAAT), and the Intrinsic Motivation Inventory (IMI) questionnaire were collected. One-sample t-test was conducted comparing the VDOT video adherence to the standard rate of 80%. RM ANOVA was used to analyze any significant differences in MyMAAT and IMI scores across three-time intervals.
RESULTS: This study involved 71 numbers of patients from 18 healthcare facilities who showed a significantly higher treatment adherence score of 90.87% than a standard score of 80% with a mean difference of 10.87(95% CI: 7.29,14.46; p
OBJECTIVES: This study conducted to investigate the most preferred OSDF and the degree to which swallowing solid medication is an issue, to assess perceptions of the therapeutic benefits of the OSDF, and to find predictors of the most preferred OSDF.
METHOD: A cross-sectional study, through convenience sample method, was conducted to survey consumers visiting community pharmacies in Baghdad, Iraq. Data was collected by self-administered and pre-piloted questionnaires, and analyzed using Statistical Package for Social Science. Multiple logistic regression analysis and Chi-square tests were used at alpha level = 0.05.
RESULTS: A total of 1,000 questionnaire were included in the analysis. Of all respondents, 52.9 % preferred capsule among other OSDF and this preference varied significantly with a number of socio-demographic factors. Ease of swallowing solid medication was the main issue which resulted in preferences for a particular form. A negative perception of the therapeutic benefits of the OSDF was found among 89.1 % of the consumers. Multiple logistic regression analysis indicated that gender, ease of swallowing, and perceptions of the therapeutic benefits of the OSDF were significant predictors of capsule preferences.
CONCLUSIONS: Given the fact that consumers are the end users of medicines and their preferences may influence response to the treatment, efforts are worthwhile by the prescribers and medicines' manufactures to understand consumers' preferences of a particular dosage form in order to achieve successful therapy outcomes.
Materials and Methods: In two tertiary care selected hospitals, the included diabetic patients were randomly divided into two study arms. In the control group, 200 patients who were receiving usual treatment from hospitals were included. However, in the intervention group, those 200 patients who were receiving usual treatment along with counseling sessions from pharmacists under the Diabetes Medication Therapy Adherence Clinic (DMTAC) program were included. The study continued for 1 year, and there were four follow-up visits for both study arms. A prevalidated data collection form was used to measure the improvement in predictors of diabetic foot in included patients. Data were analyzed by using the Statistical Package for the Social Sciences (SPSS) software program, version 24.0.
Results: With the average decrease of 1.97% of HbA1c values in the control group and 3.43% in the intervention group, the univariate and multivariate analysis showed a statistically significant difference between both of the study arms in the improvement of predictors belonging to the diabetic foot (P < 0.05). The proportion of patients without any signs and symptoms of the diabetic foot in the intervention group was 91.7%, which increased from 42.3% at baseline (P < 0.05). However, this proportion in the control group was 76.9% at the fourth follow-up, from 48.3% at baseline (P < 0.05).
Conclusion: A statistically significant reduction in the signs and symptoms of diabetic foot was observed in the intervention group at the end of 1 year. The progression of diabetic foot was significantly decreased in the pharmacist intervention group.
OBJECTIVE: This study aimed to evaluate the impact of CMI on medication adherence and glycaemic control among patients with type 2 diabetes in Qatar.
METHODS: We developed and customised CMI for all the anti-diabetic medications used in Qatar. A randomised controlled trial in which the intervention group patients (n = 66) received the customised CMI with usual care, while the control group patients (n = 74) received usual care only, was conducted. Self-reported medication adherence and haemoglobin A1c (HbA1c ) were the primary outcome measures. Glycaemic control and medication adherence parameters were measured at baseline, 3 months, and 6 months in both groups. Medication adherence was measured using the 8-item Morisky Medication Adherence Scale (MMAS-8).
RESULTS: Although the addition of CMI resulted in better glycaemic control, this did not reach statistical significance, possibly because of the short-term follow-up. The median MMAS-8 score improved from baseline (6.6 [IQR = 1.5]) to 6-month follow-up (7.0 [IQR = 1.00]) in the intervention group. In addition, there was a statistically significant difference between the intervention and the control groups in terms of MMAS-8 score at the third visit (7.0 [IQR = 1.0]) vs 6.5 (IQR = 1.25; P-value = .010).
CONCLUSION: CMI for anti-diabetic medications when added to usual care has the potential to improve medication adherence and glycaemic control among patients with type 2 diabetes. Therefore, providing better health communication and CMI to patients with diabetes is recommended.
METHODS AND FINDINGS: This is a retrospective cohort study of all adult people living with HIV (PLWH) incarcerated in Connecticut, US, during the period January 1, 2007, to December 31, 2011, and observed through December 31, 2014 (n = 1,094). Most cohort participants were unmarried (83.7%) men (77.0%) who were black or Hispanic (78.1%) and acquired HIV from injection drug use (72.6%). Prison-based pharmacy and custody databases were linked with community HIV surveillance monitoring and case management databases. Post-release RIC declined steadily over 3 years of follow-up (67.2% retained for year 1, 51.3% retained for years 1-2, and 42.5% retained for years 1-3). Compared with individuals who were not re-incarcerated, individuals who were re-incarcerated were more likely to meet RIC criteria (48% versus 34%; p < 0.001) but less likely to have VS (72% versus 81%; p = 0.048). Using multivariable logistic regression models (individual-level analysis for 1,001 individuals after excluding 93 deaths), both sustained RIC and VS at 3 years post-release were independently associated with older age (RIC: adjusted odds ratio [AOR] = 1.61, 95% CI = 1.22-2.12; VS: AOR = 1.37, 95% CI = 1.06-1.78), having health insurance (RIC: AOR = 2.15, 95% CI = 1.60-2.89; VS: AOR = 2.01, 95% CI = 1.53-2.64), and receiving an increased number of transitional case management visits. The same factors were significant when we assessed RIC and VS outcomes in each 6-month period using generalized estimating equations (for 1,094 individuals contributing 6,227 6-month periods prior to death or censoring). Additionally, receipt of antiretroviral therapy during incarceration (RIC: AOR = 1.33, 95% CI 1.07-1.65; VS: AOR = 1.91, 95% CI = 1.56-2.34), early linkage to care post-release (RIC: AOR = 2.64, 95% CI = 2.03-3.43; VS: AOR = 1.79; 95% CI = 1.45-2.21), and absolute time and proportion of follow-up time spent re-incarcerated were highly correlated with better treatment outcomes. Limited data were available on changes over time in injection drug use or other substance use disorders, psychiatric disorders, or housing status.
CONCLUSIONS: In a large cohort of CJ-involved PLWH with a 3-year post-release evaluation, RIC diminished significantly over time, but was associated with HIV care during incarceration, health insurance, case management services, and early linkage to care post-release. While re-incarceration and conditional release provide opportunities to engage in care, reducing recidivism and supporting community-based RIC efforts are key to improving longitudinal treatment outcomes among CJ-involved PLWH.