title: Evaluation of Potentially Drug-Related Patient-Reported Common Symptoms Assessed During Clinical Medication Reviews: A Cross-Sectional Observational Study.
abstract: 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).
  
  
  
  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.
  
  
  
  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.
  
  
  
  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'.
  
  
  
  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.
authors.affiliation: Department of IQ Healthcare, Radboud university medical center, Radboud Institute for Health Sciences, PO Box 9101, 6500 HB, Nijmegen, The Netherlands. tim.schoenmakers@radboudumc.nl.|Zorgapotheek Nederland BV, Utrecht, The Netherlands. tim.schoenmakers@radboudumc.nl.
authors.forename: Tim W A
authors.initials: TW
authors.lastname: Schoenmakers
authors.affiliation: Department of IQ Healthcare, Radboud university medical center, Radboud Institute for Health Sciences, PO Box 9101, 6500 HB, Nijmegen, The Netherlands.|Department of Clinical Pharmacy and Toxicology, Leiden University Medical Center, Leiden, The Netherlands.
authors.forename: Martina
authors.initials: M
authors.lastname: Teichert
authors.affiliation: Department of IQ Healthcare, Radboud university medical center, Radboud Institute for Health Sciences, PO Box 9101, 6500 HB, Nijmegen, The Netherlands.|Department of General Practice and Health Services Research, University Hospital Heidelberg, Heidelberg, Germany.
authors.forename: Michel
authors.initials: M
authors.lastname: Wensing
authors.affiliation: Department of IQ Healthcare, Radboud university medical center, Radboud Institute for Health Sciences, PO Box 9101, 6500 HB, Nijmegen, The Netherlands.|Department of Clinical Pharmacy, Radboud university medical center, Radboud Institute for Health Sciences, Nijmegen, The Netherlands.
authors.forename: Peter A G M
authors.initials: PA
authors.lastname: de Smet
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003157:Community Pharmacy Services / Q000458:organization & administration*; D003430:Cross-Sectional Studies; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D005260:Female; D006801:Humans; D016015:Logistic Models; D008297:Male; D054539:Medication Therapy Management / Q000458:organization & administration*; D008875:Middle Aged; D000071066:Patient Reported Outcome Measures; D010595:Pharmacists / Q000458:organization & administration*