Validation of an Announced Telephone Pill Count Compared to a Home-Visit Pill Count in People With Type 2 Diabetes or Cardiovascular Disease.

We aimed to assess the validity of an announced telephone pill count in people with type 2 diabetes or cardiovascular disease by comparing this method to a home-visit pill count. We also assessed whether a second telephone pill count improved accuracy. People aged ≥35 years using oral type 2 diabetes or cardiovascular disease medication were included. Thirty-four participants completed a telephone pill count followed by a home-visit pill count, and a subsample of this population (n = 11) completed a second telephone pill count. Scatterplots were used for a visual representation of the number of pills counted with both methods, intraclass correlation coefficients for agreement, and Bland-Altman plots for absolute differences and outliers. A total of 203 pill counts were conducted. The study population consisted of 53% men, with a mean age of 69.6 (±9.2) years and an average of 6.1 (±2.8) medication prescriptions per participant. Scatterplots showed that pills counted with both methods were mostly scattered around the y = x equation. Agreement between the first telephone pill count and home-visit pill count was high, with intraclass correlation coefficients of 0.96 (medication count level) and 0.98 (individual level). No learning effects were observed in the subsample (n = 11), the intraclass correlation coefficient for the first telephone pill count was 0.88 versus 0.89 for the second telephone pill count. Bland-Altman plots indicated high agreement between the two methods. An announced telephone pill count is considered a valid alternative for a home-visit pill count in people with type 2 diabetes or cardiovascular disease. A single pill count appears sufficient.

A personalised intervention programme aimed at improving adherence to oral antidiabetic and/or antihypertensive medication in people with type 2 diabetes mellitus, the INTENSE study: study protocol for a randomised controlled trial.

BACKGROUND: Medication non-adherence is a prevalent health problem in people with type 2 diabetes mellitus (T2DM). Interventions have previously been developed to improve medication adherence, but inconsistent outcomes have been reported. A potential explanation for this inconsistency is a 'one size fits all' approach, with interventions not tailored to the needs and preferences of individuals. Therefore, the aim of this study is to evaluate the effectiveness of a personalised intervention programme aimed at improving adherence to oral antidiabetic and/or antihypertensive medication in people with T2DM. METHODS: A parallel-group randomised controlled trial will be conducted in 40-50 community pharmacies in the Netherlands and the United Kingdom (UK). A total of 300 participants will be included and followed up for a period of 6 months. Participants will be people with T2DM identified as non-adherent to oral antidiabetic and/or antihypertensive medication, aged 35-75 years and mobile phone users. The intervention group will receive a personalised intervention programme that is based on one or more of the participants' pre-defined non-adherence profile(s), namely (I) Knowledge and perceptions, (II) Practical problems, (III) Side effects and (IV) Negative mood and beliefs. The intervention comprises of one or more supporting modules, namely (I) Brief messaging, (II) Clinical medication review, (III) Medication schedule, (IV) Reminding messaging, (V) Medication dispensing systems, (VI) Smart messaging, (VII) Referral to general practitioner and (VIII) Unguided web-based Self Help Application for low mood. The control group will receive usual care including access to a publicly available informative diabetes website. The primary study outcome is medication adherence measured with a telephone pill count. Secondary outcomes are systolic blood pressure, HbA1c level, self-reported medication adherence, attitude and beliefs toward medication, satisfaction with diabetes treatment, health status and medical consumption and productivity cost. In addition, a process evaluation will be undertaken to establish the fidelity, reach and the extent to which intervention delivery is normalised in the daily practice of community pharmacy teams. DISCUSSION: The study can lead to a personalised intervention programme that improves medication adherence in people with T2DM that are non-adherent to oral antidiabetic and/or antihypertensive medication. TRIAL REGISTRATION: Dutch Trial Register, Trial NL8747 , registered 02 July, 2020; ISRCTN Registry, ISRCTN36009809 , registered 05 February, 2020.

Patient-reported outcome measures for assessing health-related quality of life in people with type 2 diabetes: A systematic review.

Patient-Reported Outcome Measures (PROMs) are important tools to assess outcomes relevant to patients, with Health-Related Quality Of Life (HRQOL) as an important construct to be measured. Many different HRQOL PROMs are used in the type 2 diabetes field, however a complete overview of these PROMs is currently lacking. We therefore aimed to systematically describe and classify the content of all PROMs that have specifically been developed or validated to measure (aspects of) HRQOL in people with type 2 diabetes. A literature search was performed in PubMed and EMBASE until 31 December 2021. Studies on the development or validation of a PROM measuring HRQOL, or aspects of HRQOL, in people with type 2 diabetes were included. Title and abstract and full-text screening were conducted by two independent researchers and data extraction was performed independently by one of the researchers. Data were extracted on language in which the PROM was developed, target population, construct(s) being measured, names of (sub)scales and number of items per (sub)scale. In addition, all PROMs and subscales were classified according to specific aspects of HRQOL based on the Wilson & Cleary model (symptom status, functional status, general health perceptions) to aid researchers in PROM selection. In total 220 studies were identified that developed or validated PROMs that measure (aspects of) HRQOL in people with type 2 diabetes. Of the 116 unique HRQOL PROMs, 91 (of the subscales) measured symptom status, 60 measured functional status and 26 measured general health perceptions. In addition, 16 of the PROMs (subscales) measured global quality of life. 61 of the 116 PROMs (subscales) also include characteristics of the individual (e.g. aspects of personality, coping) or environment (e.g. social or financial support) and patient-reported experience measures (PREMs, e.g. measure of a patient's perception of their personal experience of the healthcare they have received, e.g. treatment satisfaction), which are not part of the HRQOL construct. Only 9 of the 116 PROMs measure all aspects of HRQOL based on the Wilson & Cleary model. Finally, 8 of the 116 PROMs stating to measure HRQOL, measured no HRQOL construct. In conclusion, a large number of PROMs are available for people with type 2 diabetes, which intend to measure (aspects of) HRQOL. These PROMs measure a large variety of (sub)constructs, which are not all HRQOL constructs, with a small amount of PROMs not measuring HRQOL at all. There is a need for consensus on which aspects of HRQOL should be measured in people with type 2 diabetes and which PROMs to use in research and daily practice. PROSPERO: CRD42017071012. COMET database: http://www.comet-initiative.org/studies/details/956 .

Content Validity of Patient-Reported Outcome Measures Developed for Assessing Health-Related Quality of Life in People with Type 2 Diabetes Mellitus: a Systematic Review.

PURPOSE OF REVIEW: We aimed to systematically evaluate the content validity of patient-reported outcome measures (PROMs) specifically developed to measure (aspects of) health-related quality of life (HRQOL) in people with type 2 diabetes. A systematic review was performed in PubMed and Embase of PROMs measuring perceived symptoms, physical function, mental function, social function/participation, and general health perceptions, and that were validated to at least some extent. Content validity (relevance, comprehensiveness, and comprehensibility) was evaluated using COSMIN methodology. RECENT FINDINGS: We identified 54 (different versions of) PROMs, containing 150 subscales. We found evidence for sufficient content validity for only 41/150 (27%) (subscales of) PROMs. The quality of evidence was generally very low. We found 66 out of 150 (44%) (subscales of) PROMs with evidence for either insufficient relevance, insufficient comprehensiveness, or insufficient comprehensibility. For measuring diabetes-specific symptoms, physical function, mental function, social function/participation, and general health perceptions, we identified one to 11 (subscales of) PROMs with sufficient content validity, although quality of the evidence was generally low. For measuring depressive symptoms, no PROM with sufficient content validity was identified. For each aspect of HRQL, we found at least one PROM with sufficient content validity, except for depressive symptoms. The quality of the evidence was mostly very low.

Systematic review on the measurement properties of diabetes-specific patient-reported outcome measures (PROMs) for measuring physical functioning in people with type 2 diabetes.

We aimed to systematically assess the measurement properties of diabetes-specific patient-reported outcome measures (PROMs) for measuring physical functioning, one of the core outcomes, in adults with type 2 diabetes.We performed a systematic literature search for PROMs or subscales measuring physical function that were validated to at least some extent in EMBASE and MEDLINE. Measurement properties were evaluated according to the COSMIN guideline for systematic reviews of PROMs.In total 21 articles were included, describing 12 versions of 7 unique diabetes-specific PROMs or subscales measuring physical functioning. In general, there were few high-quality studies on measurement properties of PROMs measuring physical functioning in adults with type 2 diabetes. The Dependence/Daily Life subscale of the Diabetic Foot Ulcer Scale-Short Form (DFS-SF) and the Impact of Weight on Activities of Daily Living Questionnaire (IWADL) were most extensively evaluated. Both had sufficient ratings for aspects of content validity, although with mostly very low-quality evidence. Sufficient ratings for structural validity, internal consistency, and reliability were also found for both instruments, but responsiveness was rated inconsistent for both instruments. The other PROMs or subscales often had insufficient aspects of content validity, or their unidimensionality could not be confirmed.This systematic review showed that the Dependence/Daily Life subscale of the DFS-SF and the IWADL could be used to measure physical functioning in people with type 2 diabetes in research or clinical practice, while keeping the limitations of these instruments in mind. The measurement properties that have not been evaluated extensively for these PROMs should be evaluated in future studies.The study protocol was registered in the PROSPERO database, number CRD42021234890.

Performance of prediction models for nephropathy in people with type 2 diabetes: systematic review and external validation study.

OBJECTIVES: To identify and assess the quality and accuracy of prognostic models for nephropathy and to validate these models in external cohorts of people with type 2 diabetes. DESIGN: Systematic review and external validation. DATA SOURCES: PubMed and Embase. ELIGIBILITY CRITERIA: Studies describing the development of a model to predict the risk of nephropathy, applicable to people with type 2 diabetes. METHODS: Screening, data extraction, and risk of bias assessment were done in duplicate. Eligible models were externally validated in the Hoorn Diabetes Care System (DCS) cohort (n=11 450) for the same outcomes for which they were developed. Risks of nephropathy were calculated and compared with observed risk over 2, 5, and 10 years of follow-up. Model performance was assessed based on intercept adjusted calibration and discrimination (Harrell's C statistic). RESULTS: 41 studies included in the systematic review reported 64 models, 46 of which were developed in a population with diabetes and 18 in the general population including diabetes as a predictor. The predicted outcomes included albuminuria, diabetic kidney disease, chronic kidney disease (general population), and end stage renal disease. The reported apparent discrimination of the 46 models varied considerably across the different predicted outcomes, from 0.60 (95% confidence interval 0.56 to 0.64) to 0.99 (not available) for the models developed in a diabetes population and from 0.59 (not available) to 0.96 (0.95 to 0.97) for the models developed in the general population. Calibration was reported in 31 of the 41 studies, and the models were generally well calibrated. 21 of the 64 retrieved models were externally validated in the Hoorn DCS cohort for predicting risk of albuminuria, diabetic kidney disease, and chronic kidney disease, with considerable variation in performance across prediction horizons and models. For all three outcomes, however, at least two models had C statistics >0.8, indicating excellent discrimination. In a secondary external validation in GoDARTS (Genetics of Diabetes Audit and Research in Tayside Scotland), models developed for diabetic kidney disease outperformed those for chronic kidney disease. Models were generally well calibrated across all three prediction horizons. CONCLUSIONS: This study identified multiple prediction models to predict albuminuria, diabetic kidney disease, chronic kidney disease, and end stage renal disease. In the external validation, discrimination and calibration for albuminuria, diabetic kidney disease, and chronic kidney disease varied considerably across prediction horizons and models. For each outcome, however, specific models showed good discrimination and calibration across the three prediction horizons, with clinically accessible predictors, making them applicable in a clinical setting. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42020192831.

Implementation fidelity of an intervention programme to enhance adherence to antihypertensive medication in Dutch community pharmacies.

Background Insight into the delivery of interventions is necessary to gain a better understanding of what caused an intervention to succeed or fail. The Cardiovascular medication non-Adherence Tailored Intervention (CATI) study failed to show effectiveness of a patient-tailored, pharmacist-led intervention programme on self-reported adherence to antihypertensive medication. Objective To evaluate the implementation fidelity of the CATI intervention programme. Setting Twenty Dutch community pharmacies. Method The process of a randomised controlled trial was evaluated. Both quantitative and qualitative data were collected and analysed according to Carrolls' Conceptual Framework for Implementation Fidelity. Implementation fidelity is defined as the degree to which the intervention was implemented as intended. Main outcome measure Four key intervention components of the intervention programme (i.e., first consultation: barrier identification, information and advice, written summary, and follow-up consultation). Results For most participants the key intervention components were implemented as intended. The training of pharmacists, intensive monitoring during the study and structured and easy-to-use intervention materials facilitated the implementation of the intervention. The method to select participants for the intervention programme was considered insufficient and pharmacists questioned the eligibility of some participants because of a low degree of intake non-adherence. Conclusion Implementation fidelity was moderate to high for all key intervention components. Therefore, the absence of effectiveness of the CATI intervention programme on self-reported medication adherence cannot be explained by poor implementation of the intervention. However, the limited genuine eligibility of some participants resulted in a limited potential for improvement in medication adherence.

The association between GAD65 antibody levels and incident Type 2 Diabetes Mellitus in an adult population: A meta-analysis.

CONTEXT: Antibodies to the 65 kD isoform of glutamic acid decarboxylase (GAD65) have been associated with incident Type 2 Diabetes Mellitus, however results are inconsistent. OBJECTIVE: To assess the association between GAD65 antibody positivity and incident Type 2 Diabetes Mellitus in a non-diabetic adult (≥18 years) population, in a systematic review and meta-analysis. DATA SOURCES: A systematic literature search was conducted in Pubmed (MEDLINE) and Embase until January 14th, 2019. STUDY SELECTION: Included studies were 1) prospective studies on the association between GAD65 antibodies and incident Type 2 Diabetes Mellitus; 2) in a non-diabetic adult (≥18 years) population. To strengthen the review, unpublished data from 1302 Hoorn Study participants were included. DATA EXTRACTION: Data extraction and quality assessment were performed independently by two observers. Ten studies were rated for methodological quality and seven were pooled using a random-effects meta-analysis, of which 2 strong, 2 moderate and 3 of low methodological quality. DATA SYNTHESIS: The pooled risk estimate of incident Type 2 Diabetes Mellitus for GAD65 antibody positivity, compared to GAD65 antibody negativity was 3.36 (95% CI: 1.9-5.9). This result was robust to sensitivity analyses. Heterogeneity between studies was significant with I2 statistic of 79% (p < 0.0001). However, excluding one study showed a decrease of I2 to 19% (p < 0.0001), explaining a large part of the heterogeneity. CONCLUSION: GAD65 antibody positivity was associated with an increased risk of future Type 2 Diabetes Mellitus in adults.