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1.
Br J Clin Pharmacol ; 84(12): 2729-2746, 2018 12.
Article in English | MEDLINE | ID: mdl-30171617

ABSTRACT

AIMS: Understanding how much healthcare professionals (HCPs) know about medication can help in devising strategies to improve rational medication use. This study aimed to synthesize information on the level of medication knowledge of HCPs in Africa. METHOD: We performed a systematic literature study in Embase and PubMed. We included original studies quantifying HCPs' medication knowledge, published between 2012 and 2016. We extracted disease focus, country, number and type of HCPs included and all medication-related knowledge questions and scored the quality of papers. The outcome measure was the percentage of HCPs who correctly answered medication knowledge questions. RESULTS: We identified 64 studies from 12 African countries, comprising 13 911 HCPs, mostly nurses/midwifes and physicians. We extracted 306 medication-related knowledge questions, and only 52% (SD 28) of HCPs correctly answered them. Knowledge questions were mainly about medication prescribed for communicable diseases (70%), followed by non-communicable diseases (11%), and family planning/gynaecology (10%). Most papers concluded that there was a considerable medication knowledge gap among HCPs. CONCLUSION: We found a low level of medication knowledge across different disease areas, countries and HCPs. This underlines the continuous need to strengthen the undergraduate and postgraduate education in (clinical) pharmacology and therapeutics in Africa.


Subject(s)
Drug Therapy , Health Knowledge, Attitudes, Practice , Health Personnel , Africa , Humans , Outcome Assessment, Health Care , Pharmacology
2.
Health Expect ; 21(1): 64-74, 2018 02.
Article in English | MEDLINE | ID: mdl-28636186

ABSTRACT

BACKGROUND: Decision aids can be used to support shared decision making (SDM). A patient-oriented treatment decision aid (DA) was developed for type 2 diabetes but its use by general practice staff appeared to be limited. OBJECTIVES: To explore views of practice staff towards SDM and the DA. DESIGN: A mixed-methods study within the Dutch PORTDA-diab trial. SETTING AND PARTICIPANTS: Included were 17 practices with staff members who were responsible for routine diabetes care and had worked with the DA, and 209 of their patients. METHODS: Interviews were conducted focusing on applicability, usefulness and feasibility of the DA. Interviews were tape-recorded, transcribed verbatim and subjected to content analysis for identifying and classifying views. Patient-reported data about the use of the DA were collected. Associations between specific views and use of the DA were tested using Pearson point-biserial correlation. RESULTS: The majority of practice staff expressed positive views towards SDM, which was associated with making more use of the DA. Most of the staff expressed that the DA stimulated a two-way conversation. By using the DA, several became aware of their paternalistic approach. Some staff experienced a conflict with the content of the DA, which was associated with making less use of the DA. CONCLUSIONS: The DA was considered useful by practice staff to support SDM. A positive view towards SDM was a facilitator, whereas experiencing a conflict with the content of the DA was a barrier for making use of the DA.


Subject(s)
Decision Making , Decision Support Techniques , Diabetes Mellitus, Type 2/therapy , Health Personnel , Humans , Interviews as Topic , Netherlands , Patient Education as Topic/methods , Primary Health Care
3.
BMJ Open ; 7(8): e015743, 2017 Aug 03.
Article in English | MEDLINE | ID: mdl-28775184

ABSTRACT

OBJECTIVES: We examined determinants of achieving blood pressure control in patients with hypertension and of treatment intensification in patients with uncontrolled blood pressure (BP). DESIGN: A retrospective cohort study in six public hospitals, Ethiopia. PARTICIPANTS: Adult ambulatory patients with hypertension and with at least one previously prescribed antihypertensive medication in the study hospital. OUTCOME: Controlled BP (<140/90 mm Hg) and treatment intensification of patients with uncontrolled BP. RESULTS: The study population comprised 897 patients. Their mean age was 57 (SD 14) years, 63% were females, and 35% had one or more cardiometabolic comorbidities mainly diabetes mellitus. BP was controlled in 37% of patients. Treatment was intensified for 23% patients with uncontrolled BP. In multivariable (logistic regression) analysis, determinants positively associated with controlled BP were treatment at general hospitals (OR 1.89, 95% CI 1.26 to 2.83) compared with specialised hospitals and longer treatment duration (OR 1.04, 95% CI 1.01 to 1.06). Negatively associated determinants were previously uncontrolled BP (OR 0.30, 95% CI 0.21 to 0.43), treatment regimens with diuretics (OR 0.68, 95% CI 0.50 to 0.94) and age (OR 0.99, 95% CI 0.98 to 1.00). The only significant-positive-determinant for treatment intensification was duration of therapy (OR 1.05, 95% CI 1.02 to 1.09). CONCLUSIONS: The level of controlled BP and treatment intensification practice in this study was low. The findings suggest the need for in-depth understanding and interventions of the identified determinants such as uncontrolled BP on consecutive visits, older age and type of hospital.


Subject(s)
Ambulatory Care , Antihypertensive Agents/therapeutic use , Blood Pressure/drug effects , Diuretics/therapeutic use , Hospitals , Hypertension/drug therapy , Adult , Age Factors , Aged , Comorbidity , Diabetes Mellitus , Ethiopia , Female , Humans , Logistic Models , Male , Middle Aged , Odds Ratio , Retrospective Studies , Risk Factors , Treatment Outcome
4.
Pharmacoepidemiol Drug Saf ; 26(10): 1242-1247, 2017 Oct.
Article in English | MEDLINE | ID: mdl-28799295

ABSTRACT

PURPOSE: The STOPP/START criteria are increasingly used to assess prescribing quality in elderly patients at practice level. Our aim was to test computerized algorithms for applying these criteria to a medical record database. METHODS: STOPP/START criteria-based computerized algorithms were defined using Anatomical-Therapeutic-Chemical (ATC) codes for medication and International Classification of Primary Care (ICPC) codes for diagnoses. The algorithms were applied to a Dutch primary care database, including patients aged ≥65 years using ≥5 chronic drugs. We tested for associations with patient characteristics that have previously shown a relationship with the original STOPP/START criteria, using multivariate logistic regression models. RESULTS: Included were 1187 patients with a median age of 75 years. In total, 39 of the 62 STOPP and 18 of the 26 START criteria could be converted to a computerized algorithm. The main reasons for inapplicability were lack of information on the severity of a condition and insufficient covering of ICPC-codes. We confirmed a positive association between the occurrence of both the STOPP and the START criteria and the number of chronic drugs (adjusted OR ranging from 1.37, 95% CI 1.04-1.82 to 3.19, 95% CI 2.33-4.36) as well as the patient's age (adjusted OR for STOPP 1.30, 95% CI 1.01-1.67; for START 1.73, 95% CI 1.35-2.21), and also between female gender and the occurrence of STOPP criteria (adjusted OR 1.41, 95% CI 1.09-1.82). CONCLUSION: Sixty-five percent of the STOPP/START criteria could be applied with computerized algorithms to a medical record database with ATC-coded medication and ICPC-coded diagnoses.


Subject(s)
Databases, Factual/standards , Drug Prescriptions/standards , Electronic Health Records/standards , Potentially Inappropriate Medication List/standards , Primary Health Care/methods , Aged , Aged, 80 and over , Algorithms , Databases, Factual/statistics & numerical data , Drug Prescriptions/statistics & numerical data , Electronic Health Records/statistics & numerical data , Feasibility Studies , Female , Humans , Inappropriate Prescribing/prevention & control , Logistic Models , Male , Netherlands , Potentially Inappropriate Medication List/statistics & numerical data , Primary Health Care/standards , Primary Health Care/statistics & numerical data
5.
Br J Clin Pharmacol ; 83(9): 2107-2117, 2017 Sep.
Article in English | MEDLINE | ID: mdl-28429533

ABSTRACT

AIMS: The aim of the present study was to evaluate the impact of adverse drug events (ADEs) and treatment satisfaction on antihypertensive medication adherence. METHODS: A cross-sectional study was conducted in six public hospitals in Ethiopia. We included adult ambulatory patients on antihypertensive medication. Adherence was measured using the eight-point Morisky Medication Adherence Scale, which categorizes as low (0-5), medium (6-7) and high (8) adherence. Treatment satisfaction was measured using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4, which included questions about ADEs. Data were analysed using generalized ordered logistic regression with 95% confidence intervals (CIs). RESULTS: We included 925 out of 968 patients. Overall, 42% of patients scored low, 37% medium and 21% high adherence. Satisfaction with treatment was low, with a mean (standard deviation) TSQM score for global satisfaction of 51 (14). A total of 193 (21%) patients experienced 421 ADEs - mainly dyspeptic symptoms (12%), headache (11%) and cough (11). Experiencing more ADEs reduced the odds of being adherent [low vs. medium/high: odds ratio (OR) OR1 0.77 (95% CI 0.67, 0.89), and low/medium vs. high: OR2 0.55 (05% CI 0.41, 0.73)]. Being more satisfied increased the odds of being adherent [low vs. medium/high: OR1 1.02 (95% CI 1.01, 1.03)]. Taking medication >1 year [OR1 = 2 , 0.60 (95% CI 0.43, 0.83)] and taking calcium channel blockers [OR1 = 2 0.71 (95% CI 0.54, 0.92)] decreased the odds for both low vs. medium/high and low/medium vs. high adherence. CONCLUSIONS: Only one in five patients reported perfect (high) adherence to their antihypertensive treatment regimen. Experiencing ADEs and being dissatisfied with treatment were associated with lower adherence. In addition to addressing treatment satisfaction and drug safety in first-world countries, these should also be addressed in resource-poor settings, within patient consultations, to enhance adherence.


Subject(s)
Ambulatory Care/psychology , Antihypertensive Agents/adverse effects , Medication Adherence/psychology , Patient Satisfaction , Cross-Sectional Studies , Female , Humans , Male , Middle Aged , Surveys and Questionnaires
6.
Br J Gen Pract ; 67(660): e501-e506, 2017 Jul.
Article in English | MEDLINE | ID: mdl-28347987

ABSTRACT

BACKGROUND: Several methods have been developed to conduct and support medication reviews in older persons with multimorbidity. Assessing the patient's priorities for achieving specific health outcomes can guide the medication review process. Little is known about the impact of conducting such assessments. AIM: This pilot study aimed to determine proposed and observed medication changes when using an outcome prioritisation tool (OPT) during a medication review in general practice. DESIGN AND SETTING: Participants were older patients with multimorbidity (aged ≥69 years) with polypharmacy (five or more chronic medications) from the practices of 14 GPs. METHOD: Patients were asked to prioritise four universal health outcomes - remaining alive, maintaining independence, reducing pain, and reducing other symptoms - using an OPT. GPs used this prioritisation to review the medication and to propose and discuss medication changes with the patient. The outcomes included the proposed medication change as documented by the GP, and the observed medication change in the electronic health record at follow-up. Descriptive analyses were conducted to determine medication changes according to the prioritised health outcomes. RESULTS: A total of 59 patients using 486 medications prioritised the four health outcomes. GPs proposed 34 changes of medication, mainly stopping, for 20 patients. At follow-up, 14 medication changes were observed for 10 patients. The stopping of medication (mostly preventive) was particularly observed in patients who prioritised 'reducing other symptoms' as most important. CONCLUSION: Using an OPT leads mainly to the stopping of medication. Medication changes appeared to be easiest for patients who prioritised 'reducing other symptoms' as most important.


Subject(s)
Chronic Disease/drug therapy , Decision Support Systems, Clinical , General Practice , Multimorbidity , Practice Patterns, Physicians'/organization & administration , Aged , Aged, 80 and over , Attitude of Health Personnel , Female , Humans , Male , Medication Therapy Management/organization & administration , Netherlands , Outcome and Process Assessment, Health Care , Pilot Projects , Polypharmacy , Quality Improvement
7.
J Am Geriatr Soc ; 64(11): e143-e148, 2016 11.
Article in English | MEDLINE | ID: mdl-27612181

ABSTRACT

OBJECTIVES: To explore an outcome prioritization tool (OPT) in eliciting individuals' preferred health outcomes (remaining alive, maintaining independence, reducing pain, reducing other symptoms) in the context of medication review in family practice. DESIGN: Cross-sectional pilot study with mixed-methods design. SETTING: Family practice. PARTICIPANTS: Multimorbid individuals (N = 60; aged ≥69) with polypharmacy (≥5 chronic medications) derived from the practice lists of a purposive sample of 13 family physicians (FPs). MEASUREMENTS: Participants were asked to prioritize each health outcome according the trade-off principle, and FPs used this prioritization for medication review. The acceptability and practicality were measured using a questionnaire for FPs and participants and semistructured interviews with FPs. RESULTS: Ninety-two percent of participants found the OPT understandable, and 55% could easily prioritize between health outcomes. Working with the OPT (mean duration 31 minutes) was a new approach for FPs, but they became more adept at using it. For FPs, the OPT provides better understanding of their patients. Participants and FPs thought that there should be a specific reason to discuss preferences, such as (expected) decline in health status. CONCLUSION: The OPT appears to be promising in eliciting patient preferences but is not suitable for routine medication review at present. Further optimization before actual use is needed (e.g., knowledge in which clinical situations the OPT is useful). More information is needed on how individuals and their families perceive the tool.


Subject(s)
Attitude of Health Personnel , Comorbidity , Family Practice , Patient Preference , Polypharmacy , Surveys and Questionnaires/standards , Aged , Cross-Sectional Studies , Family Practice/methods , Family Practice/standards , Female , Humans , Inappropriate Prescribing/prevention & control , Inappropriate Prescribing/psychology , Inappropriate Prescribing/statistics & numerical data , Male , Medication Therapy Management , Netherlands/epidemiology , Outcome and Process Assessment, Health Care , Patient Preference/psychology , Patient Preference/statistics & numerical data , Pilot Projects , Practice Patterns, Physicians' , Quality Improvement
8.
J Comp Eff Res ; 5(4): 345-54, 2016 07.
Article in English | MEDLINE | ID: mdl-27346480

ABSTRACT

AIM: Details of data quality and how quality issues were solved have not been reported in published comparative effectiveness studies using electronic health record data. METHODS: We developed a conceptual framework of data quality assessment and preprocessing and apply it to a study comparing angiotensin-converting enzyme inhibitors with angiotensin receptor blockerss on renal function decline in diabetes patients. RESULTS: The framework establishes a line of thought to identify and act on data issues. The core concept is to evaluate whether data are fit-for-use for research tasks. Possible quality problems are listed through specific signal detections, and verified whether they are true problems. Optimal solutions are selected for the identified problems. CONCLUSION: This framework can be used in observational studies to improve validity of results.


Subject(s)
Comparative Effectiveness Research , Data Accuracy , Electronic Health Records , Humans , Netherlands , Primary Health Care
9.
J Comp Eff Res ; 5(3): 229-37, 2016 05.
Article in English | MEDLINE | ID: mdl-27102734

ABSTRACT

AIM: To compare effectiveness of angiotensin-converting enzyme inhibitors (ACEis)/angiotensin receptor blockers (ARBs) for protecting Type 2 diabetes mellitus (DM2) patients from renal function decline in a real-world setting. METHODS: Retrospective cohort study of new ACEi/ARB users in 2007-2012 in an unselected primary care DM2 population. Outcome is decline in renal function stage (combining estimated glomerular filtration rate and albuminuria). Patients were matched on a propensity score. Extended Cox models with time-varying covariates were used to estimate hazard ratios of outcome. RESULTS: The time to renal function decline for ARB users was slightly, but not significantly longer than for ACEi users (hazard ratio: 0.80; 95% CI: 0.58-1.10; p = 0.166). CONCLUSION: This study did not show significant differences between the classes in preventing renal function decline in DM2 patients in primary care.


Subject(s)
Angiotensin Receptor Antagonists/pharmacology , Angiotensin-Converting Enzyme Inhibitors/pharmacology , Diabetes Mellitus, Type 2/complications , Kidney/physiopathology , Albuminuria , Humans , Retrospective Studies
10.
PLoS One ; 10(10): e0139755, 2015.
Article in English | MEDLINE | ID: mdl-26445349

ABSTRACT

OBJECTIVES: To assess whether patients' willingness to add a blood pressure-lowering drug and the importance they attach to specific treatment characteristics differ among age groups in patients with type 2 diabetes. MATERIALS AND METHODS: Patients being prescribed at least an oral glucose-lowering and a blood pressure-lowering drug completed a questionnaire including a discrete choice experiment. This experiment contained choice sets with hypothetical blood pressure-lowering drugs and a no additional drug alternative, which differed in their characteristics (i.e. effects and intake moments). Differences in willingness to add a drug were compared between patients <75 years (non-aged) and ≥75 years (aged) using Pearson χ²-tests. Multinomial logit models were used to assess and compare the importance attached to the characteristics. RESULTS: Of the 161 patients who completed the questionnaire, 151 (72%) could be included in the analyses (mean age 68 years; 42% female). Aged patients were less willing to add a drug than non-aged patients (67% versus 84% respectively; P = 0.017). In both age groups, the effect on blood pressure was most important for choosing a drug, followed by the risk of adverse drug events and the risk of death. The effect on limitations due to stroke was only significant in the non-aged group. The effect on blood pressure was slightly more important in the non-aged than the aged group (P = 0.043). CONCLUSIONS: Aged patients appear less willing to add a preventive drug than non-aged patients. The importance attached to various treatment characteristics does not seem to differ much among age groups.


Subject(s)
Antihypertensive Agents/therapeutic use , Blood Pressure/drug effects , Diabetes Mellitus, Type 2/complications , Diabetes Mellitus, Type 2/physiopathology , Patient Compliance , Stroke/prevention & control , Age Factors , Aged , Aged, 80 and over , Choice Behavior , Female , Humans , Logistic Models , Male , Middle Aged , Risk Factors , Stroke/epidemiology , Surveys and Questionnaires
11.
PLoS One ; 10(9): e0138284, 2015.
Article in English | MEDLINE | ID: mdl-26383873

ABSTRACT

BACKGROUND: Evidence from developed countries showed that medication errors are common and harmful. Little is known about medication errors in resource-restricted settings, including Vietnam. OBJECTIVES: To determine the prevalence and potential clinical outcome of medication preparation and administration errors, and to identify factors associated with errors. METHODS: This was a prospective study conducted on six wards in two urban public hospitals in Vietnam. Data of preparation and administration errors of oral and intravenous medications was collected by direct observation, 12 hours per day on 7 consecutive days, on each ward. Multivariable logistic regression was applied to identify factors contributing to errors. RESULTS: In total, 2060 out of 5271 doses had at least one error. The error rate was 39.1% (95% confidence interval 37.8%- 40.4%). Experts judged potential clinical outcomes as minor, moderate, and severe in 72 (1.4%), 1806 (34.2%) and 182 (3.5%) doses. Factors associated with errors were drug characteristics (administration route, complexity of preparation, drug class; all p values < 0.001), and administration time (drug round, p = 0.023; day of the week, p = 0.024). Several interactions between these factors were also significant. Nurse experience was not significant. Higher error rates were observed for intravenous medications involving complex preparation procedures and for anti-infective drugs. Slightly lower medication error rates were observed during afternoon rounds compared to other rounds. CONCLUSIONS: Potentially clinically relevant errors occurred in more than a third of all medications in this large study conducted in a resource-restricted setting. Educational interventions, focusing on intravenous medications with complex preparation procedure, particularly antibiotics, are likely to improve patient safety.


Subject(s)
Hospitals, Public/statistics & numerical data , Hospitals, Urban/statistics & numerical data , Medication Errors/statistics & numerical data , Drug Administration Routes , Drug Dosage Calculations , Humans , Outcome Assessment, Health Care , Prevalence , Risk Factors , Vietnam/epidemiology
12.
Trop Med Int Health ; 20(6): 797-806, 2015 Jun.
Article in English | MEDLINE | ID: mdl-25704305

ABSTRACT

OBJECTIVE: Identifying key features in individual case safety reports (ICSR) of suspected adverse drug reactions (ADRs) with cardiometabolic drugs from sub-Saharan Africa (SSA) compared with reports from the rest of the world (RoW). METHODS: Reports on suspected ADRs of cardiometabolic drugs (ATC: A10[antidiabetic], B01[antithrombotics] and C[cardiovascular]) were extracted from WHO Global database, VigiBase(®) (1992-2013). We used vigiPoint, a logarithmic odds ratios (log2 OR)-based method to study disproportional reporting between SSA and RoW. Case-defining features were considered relevant if the lower limit of the 99% CI > 0.5. RESULTS: In SSA, 3773 (9%) of reported ADRs were for cardiometabolic drugs, in RoW for 18%. Of these, 79% originated from South Africa and 81% were received after 2007. Most reports were for drugs acting on the renin-angiotensin system (36% SSA & 14% RoW). Compared with RoW, reports were more often sent for patients 18-44 years old (log2 OR 0.95 [99 CI 0.80; 1.09]) or with non-fatal outcome (log2 OR 1.16 [99 CI 1.10; 1.22]). Eight ADRs (cough, angioedema, lip swelling, face oedema, swollen tongue, throat irritation, drug ineffective and blood glucose abnormal) and seven drugs (enalapril, rosuvastatin, perindopril, vildagliptin, insulin glulisine, nifedipine and insulin lispro) were disproportionally more reported in SSA than in the RoW. CONCLUSIONS: 'In recent years, the number of adverse drug reactions (ADRs) reported in Sub-Saharan Africa (SSA) has sharply increased. The data showed the well-known population-based differential ADR profile of ACE inhibitors in the SSA population.'


Subject(s)
Cardiovascular Agents/adverse effects , Drug-Related Side Effects and Adverse Reactions/epidemiology , Fibrinolytic Agents/adverse effects , Hypoglycemic Agents/adverse effects , Adolescent , Adult , Africa South of the Sahara/epidemiology , Aged , Databases, Factual , Female , Humans , Male , Middle Aged
13.
Br J Clin Pharmacol ; 79(6): 978-87, 2015 Jun.
Article in English | MEDLINE | ID: mdl-25469876

ABSTRACT

AIMS: To compare the values regulators attach to different drug effects of oral antidiabetic drugs with those of doctors and patients. METHODS: We administered a 'discrete choice' survey to regulators, doctors and patients with type 2 diabetes in The Netherlands. Eighteen choice sets comparing two hypothetical oral antidiabetic drugs were constructed with varying drug effects on glycated haemoglobin, cardiovascular risk, bodyweight, duration of gastrointestinal complaints, frequency of hypoglycaemia and risk of bladder cancer. Responders were asked each time which drug they preferred. RESULTS: Fifty-two regulators, 175 doctors and 226 patients returned the survey. Multinomial conditional logit analyses showed that cardiovascular risk reduction was valued by regulators positively (odds ratio 1.98, 95% confidence interval 1.11-3.53), whereas drug choices were negatively affected by persistent gastrointestinal problems (odds ratio 0.24, 95% confidence interval 0.14-0.41) and cardiovascular risk increase (odds ratio 0.49, 95% confidence interval 0.27-0.87). Doctors and patients valued these effects in a similar manner to regulators. The values that doctors attached to large changes in glycated haemoglobin and that both doctors and patients attached to hypoglycaemia and weight gain also reached statistical significance. No group's drug choice was affected by a small absolute change in risk of bladder cancer when presented in the context of other drug effects. When comparing the groups, the value attached by regulators to less frequent hypoglycaemic episodes was significantly smaller than by patients (P = 0.044). CONCLUSIONS: Regulators may value major benefits and risks of drugs for an individual diabetes patient mostly in the same way as doctors and patients, but differences may exist regarding the value of minor or short-term drug effects.


Subject(s)
Attitude of Health Personnel , Diabetes Mellitus, Type 2/drug therapy , Drug and Narcotic Control , Health Knowledge, Attitudes, Practice , Hypoglycemic Agents/administration & dosage , Patient Preference , Practice Patterns, Physicians' , Administration, Oral , Aged , Biomarkers/blood , Blood Glucose/drug effects , Blood Glucose/metabolism , Cardiovascular Diseases/chemically induced , Cardiovascular Diseases/prevention & control , Choice Behavior , Diabetes Mellitus, Type 2/blood , Diabetes Mellitus, Type 2/complications , Diabetes Mellitus, Type 2/diagnosis , Female , Gastrointestinal Diseases/chemically induced , Glycated Hemoglobin/metabolism , Humans , Hypoglycemia/chemically induced , Hypoglycemic Agents/adverse effects , Logistic Models , Male , Middle Aged , Netherlands , Odds Ratio , Risk Assessment , Risk Factors , Surveys and Questionnaires , Time Factors , Treatment Outcome , Weight Gain/drug effects
14.
BMJ ; 349: g5651, 2014 Sep 25.
Article in English | MEDLINE | ID: mdl-25255799

ABSTRACT

OBJECTIVE: To assess the effects of a patient oriented decision aid for prioritising treatment goals in diabetes compared with usual care on patient empowerment and treatment decisions. DESIGN: Pragmatic randomised controlled trial. SETTING: 18 general practices in the north of the Netherlands. PARTICIPANTS: 344 patients with type 2 diabetes aged ≤ 65 years at the time of diagnosis and managed in primary care between April 2011 and August 2012: 225 were allocated to the intervention group and 119 to the usual care group. INTERVENTION: The intervention comprised a decision aid for people with diabetes, with individually tailored risk information and treatment options for multiple risk factors. The aid was intended to empower patients to prioritise between clinical domains and to support treatment decisions. It was offered to participants before a regular diabetes check-up and to their healthcare provider during the consultation. Four different formats of the decision aid were included for additional explorative analyses. MAIN OUTCOME MEASURES: The primary outcome was the effects on patient empowerment for setting and achieving goals. The secondary outcomes were changes in the prescribing of drugs to regulate glucose, blood pressure, lipids, and albuminuria. Data were collected through structured questionnaires and automated data extraction from electronic health records during six months before and after the intervention. RESULTS: Of all intervention participants, 103 (46%) reported to have received the basic elements of the intervention. For the primary outcome analysis, 199 intervention and 107 control patients with sufficient baseline and follow-up data could be included. The mean empowerment score increased 0.1 on a 5 point scale in the overall intervention group, which was not significantly different from that of the control group (mean difference after adjusting for baseline 0.039, 95% confidence interval -0.056 to 0.134). Lipid regulating drug treatment was intensified in 25% of intervention and 12% of control participants with increased cholesterol levels, which did not reach significance when the intervention was compared with the usual care group (odds ratio 2.54, 95% confidence interval 0.89 to 7.23). Prespecified explorative analyses showed that this effect was significant for the printed version of the decision aid in comparison to usual care (3.90, 1.29 to 11.80). No relevant or significant changes were seen for other treatments. CONCLUSION: We found no evidence that the patient oriented treatment decision aid improves patient empowerment by an important amount. The aid was not used to its full extent in a substantial number of participants. TRIAL REGISTRATION: Dutch trial register NTR1942.


Subject(s)
Decision Support Techniques , Diabetes Mellitus, Type 2/therapy , Patient-Centered Care , Female , Goals , Humans , Male , Middle Aged
15.
Health Qual Life Outcomes ; 12: 103, 2014 Aug 13.
Article in English | MEDLINE | ID: mdl-25115618

ABSTRACT

BACKGROUND: Direct patient-reported information about adverse drug events (ADEs) is important since it adds to healthcare professional-reported information about the safety of drugs. Previously, we developed an instrument to assess patient-reported ADEs in research settings. The aim of this study is to assess the construct and concurrent validity of the questionnaire. METHODS: Patients on at least an oral glucose-lowering drug completed the ADE questionnaire, the World Health Organization Quality of Life-BREF, and the Treatment Satisfaction Questionnaire for Medication (TSQM). The ADE questionnaire assesses ADEs for any drug that the patient uses. Construct validity was assessed by testing whether patients reporting an ADE had a lower general quality of life and physical health than those not reporting an ADE, using Mann-Whitney U-tests and t-tests (significance level <0.05). For concurrent validity, we tested whether ADEs that patients associate with particular drugs in the ADE questionnaire are documented in the Summary of Product Characteristics (SPC) of those drugs, and whether patients who report an ADE with the use of metformin on the TSQM, mention metformin as a drug associated with an ADE on the ADE questionnaire. Agreement of 70% with the SPC was considered satisfactory. Sensitivity and positive predictive value (PPV) were calculated for the comparison with the TSQM, where 70% was used as the cut-off level for sufficient concurrent validity. RESULTS: We included 135 patients (mean age 64 years, 35% women). Patients who reported an ADE (N = 37) had a lower general quality of life and physical health than those not reporting an ADE (P < 0.05). For 78 of the 146 reported ADEs (53%), patients mentioned at least 1 particular drug associated with the ADE. After clustering related ADEs, this resulted in 56 patient-reported ADE-drug associations. Of these, 41 (73%) were in agreement with information in the SPC. Finally, the questionnaire had a sensitivity of 38% and PPV of 79% for assessing ADEs associated with metformin. CONCLUSIONS: The construct validity of the patient-reported ADE questionnaire was sufficient for reporting any versus no ADE, but the concurrent validity was only partly demonstrated. Therefore, the questionnaire needs to be adapted before it can be used.


Subject(s)
Adverse Drug Reaction Reporting Systems , Quality of Life , Surveys and Questionnaires , Adolescent , Adult , Aged , Aged, 80 and over , Cross-Sectional Studies , Drug-Related Side Effects and Adverse Reactions/epidemiology , Female , Humans , Male , Middle Aged , Netherlands/epidemiology , Patient Satisfaction/statistics & numerical data , Reproducibility of Results , Self Report , Young Adult
16.
Qual Life Res ; 23(9): 2439-45, 2014 Nov.
Article in English | MEDLINE | ID: mdl-24848596

ABSTRACT

PURPOSE: To assess the validity of a patient-reported adverse drug events (ADEs) questionnaire with a 3-month or 4-week recall period. METHODS: Patients receiving at least one oral glucose-lowering drug were asked to report potential ADEs they experienced related to any drug in a daily diary for a 3-month period. Thereafter, they completed the ADE questionnaire with either a 3-month or 4-week recall period. The validity was assessed by comparing ADEs reported in each version with those reported in the diary at class level and at specific ADE level. At class level, a comparison was made using (1) primary system organ classes (SOCs) of the medical dictionary for regulatory activities and (2) other related SOCs. Sensitivity and positive predictive value (PPV) were calculated. RESULTS: Each version of the questionnaire was completed by 39 patients. In the 3-month group, 21 patients reported 70 ADEs in the diary. In the 4-week group, six patients reported seven ADEs in the last 4 weeks of the diary. Sensitivity to assess ADEs at primary SOC was low for both recall groups (33 %). PPV was 51 and 10 % for, respectively, the 3-month and 4-week group. Taking other related SOCs into account slightly increased the sensitivity for the 3-month group (38%). Sensitivity of reporting the same ADE was 41 and 43 % for, respectively, the 3-month and 4-week group. CONCLUSIONS: Regardless of the recall period and level of comparison, the validity for assessing ADEs was low with the patient-reported ADE questionnaire. Further refinement is needed to improve the validity.


Subject(s)
Drug-Related Side Effects and Adverse Reactions/epidemiology , Hypoglycemic Agents/adverse effects , Mental Recall , Surveys and Questionnaires , Adult , Aged , Female , Humans , Male , Middle Aged , Quality of Life , Surveys and Questionnaires/standards
17.
Diabetes Care ; 37(5): 1312-20, 2014.
Article in English | MEDLINE | ID: mdl-24595634

ABSTRACT

OBJECTIVE: To assess whether after the introduction of diabetes performance measures decreases in undertreatment correspond with increases in overtreatment for blood pressure (BP) and glycemic control in different patient age groups. RESEARCH DESIGN AND METHODS: We conducted a cohort study using data from the Groningen Initiative to Analyse Type 2 Diabetes Treatment (GIANTT) database. General practices were included when data were available from 1 year before to at least 1 year after the introduction of diabetes performance measures. Included patients had a confirmed diagnosis of type 2 diabetes. Potential overtreatment was defined as prescribing maximum treatment or a treatment intensification to patients with a sustained low-risk factor level. Potential undertreatment was defined as a lack of treatment intensification in patients with a sustained high-risk factor level. Percentages of over- and undertreated patients at baseline were compared with those in subsequent years, and stratified analyses were performed for different patient age groups. RESULTS: For BP, undertreatment significantly decreased from 61 to 57% in the first year after the introduction of performance measures. In patients >75 years of age, undertreatment decreased from 65 to ∼61%. Overtreatment was relatively stable (∼16%). For glycemic control, undertreatment significantly increased from 49 to 53%, and overtreatment remained relatively stable (∼7%). CONCLUSIONS: The improvement of BP undertreatment after introduction of the performance measures did not correspond with an increase in overtreatment. The performance measures appeared to have little impact on improving glucose-regulating treatment. The trends did not differ among patient age groups.


Subject(s)
Diabetes Mellitus, Type 2/drug therapy , Adult , Age Factors , Antihypertensive Agents/therapeutic use , Blood Glucose/metabolism , Blood Pressure/physiology , Blood Pressure Determination , Cohort Studies , Diabetic Angiopathies/therapy , Female , General Practice/standards , General Practice/statistics & numerical data , Glycated Hemoglobin/metabolism , Humans , Hypertension/drug therapy , Hypoglycemic Agents/therapeutic use , Male , Middle Aged , Netherlands , Quality of Health Care , Risk Factors , Unnecessary Procedures/statistics & numerical data , Unnecessary Procedures/trends
18.
BMC Nephrol ; 15: 15, 2014 Jan 15.
Article in English | MEDLINE | ID: mdl-24428868

ABSTRACT

BACKGROUND: Structured comparison of pharmacoeconomic analyses for ACEIs and ARBs in patients with type 2 diabetic nephropathy is still lacking. This review aims to systematically review the cost-effectiveness of both ACEIs and ARBs in type 2 diabetic patients with nephropathy. METHODS: A systematic literature search was performed in MEDLINE and EMBASE for the period from November 1, 1999 to Oct 31, 2011. Two reviewers independently assessed the quality of the articles included and extracted data. All cost-effectiveness results were converted to 2011 Euros. RESULTS: Up to October 2011, 434 articles were identified. After full-text checking and quality assessment, 30 articles were finally included in this review involving 39 study settings. All 6 ACEIs studies were literature-based evaluations which synthesized data from different sources. Other 33 studies were directed at ARBs and were designed based on specific trials. The Markov model was the most common decision analytic method used in the evaluations. From the cost-effectiveness results, 37 out of 39 studies indicated either ACEIs or ARBs were cost-saving comparing with placebo/conventional treatment, such as amlodipine. A lack of evidence was assessed for valid direct comparison of cost-effectiveness between ACEIs and ARBs. CONCLUSION: There is a lack of direct comparisons of ACEIs and ARBs in existing economic evaluations. Considering the current evidence, both ACEIs and ARBs are likely cost-saving comparing with conventional therapy, excluding such RAAS inhibitors.


Subject(s)
Angiotensin Receptor Antagonists/economics , Angiotensin Receptor Antagonists/therapeutic use , Angiotensin-Converting Enzyme Inhibitors/economics , Angiotensin-Converting Enzyme Inhibitors/therapeutic use , Diabetes Mellitus, Type 2/economics , Diabetic Neuropathies/drug therapy , Diabetic Neuropathies/economics , Cost-Benefit Analysis , Diabetes Mellitus, Type 2/drug therapy , European Union , Health Care Costs/statistics & numerical data , Humans
19.
J Psychosom Res ; 76(2): 134-8, 2014 Feb.
Article in English | MEDLINE | ID: mdl-24439689

ABSTRACT

OBJECTIVE: To assess the relationship of patients' medication beliefs and treatment complexity with unintentional and intentional non-adherence for three therapeutic groups commonly used by patients with type 2 diabetes. METHODS: Survey data about adherence (Medication Adherence Report Scale) and beliefs about medicines (Beliefs about Medicines Questionnaire) were combined with prescription data from the Groningen Initiative to ANalyse Type 2 diabetes Treatment (GIANTT) database. Patients were classified as being adherent, mainly unintentional non-adherent, or partly intentional non-adherent per therapeutic group (glucose-, blood pressure-, and lipid-lowering drugs). Treatment complexity was measured using the Medication Regimen Complexity Index, which includes the dosage form, dosing frequency and additional directions of taking the drug. Analyses were performed using Kruskal-Wallis and Mann-Whitney U-tests. RESULTS: Of 257 contacted patients, 133 (52%) returned the questionnaire. The patients had a mean age of 66years and 50% were females. Necessity beliefs were not significantly different between the adherers, mainly unintentional non-adherers, and partly intentional non-adherers (differences smaller than 5 points on a scale from 5 to 25). For blood pressure-lowering drugs, patients reporting intentional non-adherence had higher concern beliefs than adherers (8 point difference, P=0.01). Treatment complexity scores were lower for adherers but similar for mainly unintentional and partly intentional non-adherers to glucose- and blood pressure-lowering drugs. CONCLUSION: Treatment complexity was related to non-adherence in general. Beliefs about necessity were not strongly associated with non-adherence, while patients' concern beliefs may be associated with intentional non-adherence. However, the role of these determinants differs per therapeutic group.


Subject(s)
Diabetes Mellitus, Type 2/drug therapy , Diabetes Mellitus, Type 2/psychology , Health Knowledge, Attitudes, Practice , Hypoglycemic Agents/therapeutic use , Medication Adherence/statistics & numerical data , Aged , Cross-Sectional Studies , Culture , Female , General Practice/statistics & numerical data , Humans , Male , Netherlands , Patient Compliance/statistics & numerical data , Population Surveillance , Surveys and Questionnaires
20.
BMJ Qual Saf ; 23(4): 319-24, 2014 Apr.
Article in English | MEDLINE | ID: mdl-24195894

ABSTRACT

BACKGROUND: Little is known about interventions to reduce intravenous medication administration errors in hospitals, especially in low- and middle-income countries. OBJECTIVE: To assess the effect of a clinical pharmacist-led training programme on clinically relevant errors during intravenous medication preparation and administration in a Vietnamese hospital. METHODS: A controlled before and after study with baseline and follow-up measurements was conducted in an intensive care unit (ICU) and a post-surgical unit (PSU). The intervention comprised lectures, practical ward-based teaching sessions and protocols/guidelines, and was conducted by a clinical pharmacist and a nurse. Data on intravenous medication preparation and administration errors were collected by direct observation 12 h/day for seven consecutive days. Generalised estimating equations (GEE) were used to assess the effect of the intervention on the prevalence of clinically relevant erroneous doses, corrected for confounding factors. RESULTS: 1204 intravenous doses were included, 516 during the baseline period (236 on ICU and 280 on PSU) and 688 during the follow-up period (407 on ICU and 281 on PSU). The prevalence of clinically relevant erroneous doses decreased significantly on the intervention ward (ICU) from 64.0% to 48.9% (p<0.001) but was unchanged on the control ward (PSU) (57.9% vs 64.1%; p=0.132). GEE analysis showed that doses on the intervention ward were 2.60 (1.27-5.31) times less likely to have clinically relevant errors (p=0.013). CONCLUSIONS: The pharmacist-led training programme was effective, but the error rate remained relatively high. Further quality improvement strategies are needed, including changes to the working environment and promotion of a safety culture.


Subject(s)
Administration, Intravenous , Critical Care Nursing/education , Medication Errors/prevention & control , Pharmacists , Administration, Intravenous/adverse effects , Controlled Before-After Studies , Education, Nursing, Continuing/methods , Humans , Medication Errors/statistics & numerical data
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