Patient-reported common symptoms as an assessment of interventions in medication reviews: a randomised, controlled trial.

Background A 'Patient-Reported Outcome Measure, Inquiry into Side Effects' (PROMISE) instrument was developed for patients to report common symptoms in clinical medication reviews. Objective To determine changes in patient-reported drug-associated symptoms collected by PROMISE before and after community pharmacist-led clinical medication reviews compared with usual care. Setting Community pharmacies in the Netherlands. Methods Patients were randomised into an intervention group (IG) and a control group (CG). PROMISE was used to collect symptoms experienced during the previous month, and any suspected drug-associated symptoms from both groups at baseline and at follow-up after 3 months. IG patients received a one-time clinical medication review, while CG patients received usual care. Main outcome measure Mean number of drug-associated symptoms at follow-up. Results Measurements were completed by 78 IG and 67 CG patients from 15 community pharmacies. Mean numbers of drug-associated symptoms per patient at follow-up were 4.0 in the IG and 5.0 in the CG, with an incident rate ratio between the groups of 0.90 (95% CI 0.62-1.33). Mean numbers of drug-associated symptoms per patient reported at follow-up and persisting since baseline were 2.1 in the IG and 2.6 in the CG, with an incident rate ratio of 0.85 (95% CI 0.43-1.42). The lowest percentages of persisting drug-associated symptoms detected in the IG were 'palpitations' and 'stomach pain, dyspepsia' while in the CG they were 'stomach pain, dyspepsia' and 'trembling, shivering'. Conclusion PROMISE provided meaningful information on drug-associated symptoms in clinical medication reviews, however the number of drug-associated symptoms was not reduced by performing clinical medication reviews compared with usual care.

Evaluation of Potentially Drug-Related Patient-Reported Common Symptoms Assessed During Clinical Medication Reviews: A Cross-Sectional Observational Study.

INTRODUCTION: Healthcare professionals tend to consider common non-alarming drug-related symptoms to be of little clinical relevance. However, such symptoms can have a substantial impact on the individual patient. Insight into patient-reported symptoms could aid pharmacists to identify improvements in medication treatment, for instance in the patient interview at the start of a clinical medication review (CMR). OBJECTIVE: The objectives of this study were to describe the numbers and types of patient-reported symptoms assessed during a CMR and to elucidate their potential association with the drugs in use. METHODS: This observational study was performed using data from a clinical trial on patient-reported outcomes of CMRs. Patients taking at least five drugs and who were eligible for a CMR were selected by 15 community pharmacies. Patients were asked to fill in a structured instrument, the Patient Reported Outcome Measure, Inquiry into Side Effects (PROMISE). Among other domains, this instrument offers a list of 22 symptom categories to report symptoms and their relationship with the drugs in use. The results of the PROMISE instrument together with information on patients' actual drug use were available for analysis. Besides descriptive analysis, associations with side effects as listed in the summary of product characteristics (SPC) of the drugs in use were assessed with logistic regression analysis. RESULTS: Of the 180 patients included, 168 patients (93.3%) reported at least one symptom via the PROMISE instrument, which could be discussed with the pharmacist during the patient interview. In total, the patients reported 1102 symptoms in 22 symptom categories. Of these patients, 101 (56.1%) assumed that at one or more of the symptoms experienced were related to the drugs in use and 107 (59.4%) reported at least one symptom that corresponded to a 'very common' side effect listed in the SPC of a drug in use. Each additional drug in use with a specific symptom listed as a 'very common' side effect in its SPC statistically significantly increased the probability of a patient reporting the symptoms of 'dry mouth/thirst, mouth complaints', 'constipation', 'diarrhoea' and 'sweating'. CONCLUSION: Many patient-reported symptoms and symptoms potentially related to drugs in use were identified by administering the PROMISE instrument to users of at least five drugs being taking long-term. This information can be used in CMRs to improve patients' drug therapy.

Evaluation of quality indicators for Dutch community pharmacies using a comprehensive assessment framework.

BACKGROUND: In 2008, the Dutch Health Care Transparency Programme (Zichtbare Zorg) was set up to develop and apply quality indicators (QIs) for health care. These QIs serve a range of purposes and can be categorized into those for internal use--for meeting quality standards and to continuously measure improvement (formative)--and external use--to enable patients and health insurance companies to distinguish between health care providers (summative). In order to assess the validity of QIs, a comprehensive Indicator Assessment Framework (IAF) was developed. This framework specifies the following criteria for validation: content validity, absence of selection bias, absence of measurement bias, and statistical reliability. Because of the intended summative use, the IAF was used for structural assessment of the QIs set for Dutch community pharmacists. OBJECTIVE: To assess the validity of the current set of 52 QIs for community pharmacies using the IAF. METHODS: An expert panel applied the IAF criteria to the set of QIs collected in 1,807 Dutch community pharmacies on their performance in 2011. The QIs were judged as meeting, partly meeting, or not meeting the requirements regarding these criteria. The judgments were evaluated for QI type (structure, process, or outcome) and for predefined domains. RESULTS: Thirteen QIs (25%) were judged as meeting the requirements for all criteria. Among them were 12 structure indicators and 1 process indicator. For process indicators, the criterion for measurement bias poorly met the requirements, and content validity was unsatisfactory for outcome indicators. The 13 overall valid QIs covered 6 out of 10 predefined domains: continuity of care, clinical risk management, compounding, dispensing of medication, management, and quality management. CONCLUSIONS: When subjecting the QI set for community pharmacies to the requirements of the IAF, only a quarter of the QIs met all requirements. To increase the number of valid process and outcome indicators, meaningful aspects for the outcome of pharmaceutical care have to be defined, and uniform measurement of relevant processes has to be implemented.