DATA SOURCES: The articles published in PubMed, MEDLINE and Google Scholar were searched using text words: off-label, unlicensed, paediatric and children. Additional articles were identified by reviewing the bibliography of the retrieved articles. Full-text articles published in English which reported on the prevalence of off-label prescribing in children between January 1996 and December 2016 were included.
RESULTS: A total of 101 studies met the inclusion criteria. Off-label prescribing definition included four main categories: age, indication, dose and route of administration. The three most common reference sources used in the studies were summary of product characteristics, national formularies and package inserts. Overall, the off-label prescribing rates in children ranged from 1.2 to 99.7%. The most common category of off-label prescribing in children was dose and age.
CONCLUSIONS: This review highlighted that off-label prescribing in children was found to be highly prevalent throughout the past two decades, persistently in the neonatal intensive care units. This suggests that besides legislative and regulatory initiatives, behavioural, knowledge aspects and efforts to integrate evidence into practice related to off-label prescribing also need to be evaluated and consolidated as part of the concerted efforts to narrow the gaps in prescribing for children.
AIM: To assess the diabetes empowerment scores and its correlated factors among type 2 diabetes patients in a primary care clinic in Malaysia.
METHODS: This is a cross sectional study involving 322 patients with type 2 diabetes mellitus (DM) followed up in a primary care clinic. Systematic sampling method was used for patient recruitment. The Diabetes Empowerment Scale (DES) questionnaire was used to measure patient empowerment. It consists of three domains: (1) Managing the psychosocial aspect of diabetes (9 items); (2) Assessing dissatisfaction and readiness to change (9 items); and (3) Setting and achieving diabetes goal (10 items). A score was considered high if it ranged from 100 to 140. Data analysis was performed using SPSS version 25 and multiple linear regressions was used to identify the predictors of total diabetes empowerment scores.
RESULTS: The median age of the study population was 55 years old. 56% were male and the mean duration of diabetes was 4 years. The total median score of the DES was 110 [interquartile range (IQR) = 10]. The median scores of the three subscales were 40 with (IQR = 4) for "Managing the psychosocial aspect of diabetes"; 36 with (IQR = 3) for "Assessing dissatisfaction and readiness to change"; and 34 with (IQR = 5) for "Setting and achieving diabetes goal". According to multiple linear regressions, factors that had significant correlation with higher empowerment scores among type 2 diabetes patients included an above secondary education level (P < 0.001), diabetes education exposure (P = 0.003), lack of ischemic heart disease (P = 0.017), and lower glycated hemoglobin (HbA1c) levels (P < 0.001).
CONCLUSION: Diabetes empowerment scores were high among type 2 diabetes patients in this study population. Predictors for high empowerment scores included above secondary education level, diabetes education exposure, lack of ischemic heart disease status and lower HbA1c.
METHODS: Three hundred patients treated for uncomplicated malaria in selected primary healthcare facilities of Plateau state, Nigeria, completed the EQ-5D-5L scale. Classical test theory was used to establish validity and Cronbach's alpha reliability of the scale. Rasch analysis was used to confirm the unidimensionality, item fitness, item and person separations and reliabilities, and targeting of item difficulty to patient ability levels and presentation on Wright map (item-person map).
RESULTS: The outcome of classical test theory revealed unidimensional scale with average variance extracted values > 0.5, and the square root of the average variance extracted for construct was greater than the correlation coefficients, indicating convergent and discriminant validities of the scale whose Cronbach's alpha coefficient (α) was 0.87. Rasch analysis indicated variance explained values of 88.3% and the eigenvalues of the first contrast was 1.3, further confirming the unidimensionality of the scale, whose fit index values were within accepted ranges. The high item and person separation and reliability values indicated the instrument's strength in detecting and evenly spreading items and persons on the Wright map based on item difficulty and the respondents' ability levels, respectively.
CONCLUSION: The EQ-5D-5L scale performed well in uncomplicated malaria, hence, it is recommended for use in the assessment of health-related quality of life in this patient population.
METHOD: Baseline data from a large study entitled Evaluation of Enhanced Primary Health Care interventions in public health clinics (EnPHC-EVA: Facility) were used in this analysis. Data from 40 public primary care clinics were collected through retrospective chart reviews and a patient exit survey. We calculated the ICCs for processes of care, clinical outcomes and patient experiences in patients with T2D and/or hypertension using the analysis of variance approach.
RESULTS: Patient experience had the highest ICC values compared to processes of care and clinical outcomes. The ICC values ranged from 0.01 to 0.48 for processes of care. Generally, the ICC values for processes of care for patients with hypertension only are higher than those for T2D patients, with or without hypertension. However, both groups of patients have similar ICCs for antihypertensive medications use. In addition, similar ICC values were observed for clinical outcomes, ranging from 0.01 to 0.09. For patient experience, the ICCs were between 0.03 (proportion of patients who are willing to recommend the clinic to their friends and family) and 0.25 (for Patient Assessment of Chronic Illness Care item 9, Given a copy of my treatment plan).
CONCLUSION: The reported ICCs and their respective 95% confidence intervals for T2D and hypertension will be useful for estimating sample sizes and improving efficiency of cluster trials conducted in the primary care setting, particularly for low- and middle-income countries.
Methods: The development phase consists of both literature and expert panel review. The validation phase consists of content validity, face validity, and construct validity. Cronbach's alpha was used to verify internal consistency. The development phase produced a questionnaire with 3 domains: perception, attitude, and practice consisting of 60 items (PAP-PCP questionnaire). Item response theory analysis for perception demonstrated the difficulty and discrimination values were acceptable except for 3 items. Exploratory factor analysis for attitude and practice domains showed the psychometric properties were good except for 3 items in practice domain. Experts judgement was used to decide on the final selection of questionnaire which consists of 59 items.
Results: The final validated questionnaire has 3 domains with 59 items. All domains had Cronbach's alpha above 0.65 which was reliable. 302 physicians completed the questionnaire. 98% PCPs diagnosed AR based on clinical history. Although, majority agree AR guidelines is useful (67%), they had difficulty in using it to classify AR (54.9%) and determine AR severity (73.9%). Oral anti-histamines (first and second generation) were the most prescribed (>75%) followed by intranasal corticosteroids (59%) and combined intranasal corticosteroid and oral anti-histamine (51%). Majority agreed that treatment efficacy (81.8%), adverse effects (83.8%), fear of adverse effects (73.5%), route of administration (69.4%), dosing frequency (72.5%), taste (64.6%) and cost (73.5%) affect treatment compliance.
Conclusions: The newly developed and validated questionnaire is a promising instrument in understanding the treatment gap in AR. Although further testing and refinement are needed, it provides an initial means for evaluating knowledge and understanding of PCPs in treating AR.