A pilot study testing the feasibility of skin temperature monitoring to reduce recurrent foot ulcers in patients with diabetes - a randomized controlled trial

Background: Although monitoring foot skin temperatures has been associated with diabetic foot ulcer recurrence, no studies have been carried out to test the feasibility among European Caucasians. Moreover, the educational and/or motivational models that promote cognitive or psychosocial processes in these studies are lacking. Thus, we conducted a pilot randomized controlled trial to test the feasibility of monitoring foot skin temperatures in combination with theory-based counselling to standard foot care to reduce diabetic foot ulcer recurrence.Methods: In a single-blinded nurse-led 1-year controlled trial, conducted at a hospital setting in Norway, 41 patients with diabetic neuropathy and previous foot ulcer were randomized to the intervention (n = 21) or control groups (n = 20). All participants were instructed in foot care and recording observations daily. Additionally, the intervention group was taught how to monitor and record skin temperature at baseline, and received counselling every third month supporting them to use the new treatment. Subjects observing temperature differences >2.0 °C between corresponding sites on the left and right foot on two consecutive days were asked to contact the study nurse and reduce physical activity. Fisher exact test was used to evaluate the effect of the intervention on the proportion of subjects with a foot ulcer. Kaplan-Meier survival analysis was performed to compare the two groups in regard to the time to development of a foot ulcer.Results: In the intervention group, 67 % (n = 14/21) monitored and recorded skin temperatures ≥80 % of the time while 70 % (n = 14/20) of the controls recorded foot inspections. Foot ulcer incidence was 39 % (7/21) vs. 50 % (10/20) in the intervention and control groups, respectively (ns). Conclusions: This feasibility study showed that the addition of counselling to promote self-monitoring of skin temperature to standard care to prevent recurrence of foot ulcer is feasible in patients with diabetes in Norway. Home skin temperature monitoring was performed as frequently by the intervention group as usual foot observations in the controls despite the extra effort required. We did not detect a difference in foot ulcer recurrence between groups, but our study may inform future full scale studies. Trial registration: Clinicaltrials.gov NCT01269502

Evaluating categorization and clinical relevance of drug-related problems in medication reviews

Beskriver en intervensjonsstudie hvor hensikten var å evaluere kategorisering og klinisk relevans av legemiddelrelaterte problem identifisert av kommune-farmasøyter, og vurdere kvaliteten på intervensjoner med pasienter og leger som dokumentert av farmasøyter.Objectives: we aimed to evaluate the categorisation and clinical relevance of DRPs identified by community pharmacists, and further, to assess the quality of interventions with the patients and the physicians as documented by the pharmacists. Setting 23 Norwegian community pharmacies. Method: patients with type 2 diabetes were recruited by 24 community pharmacists who performed structured medication reviews based on the patients’ drug profiles and patient interviews. The DRPs identified were subsequently categorised. An evaluation group (EG) retrospectively evaluated the reviews. Clinical/practical relevance of each DRP and quality of community pharmacists’ intervention with patients and physician were scored. Average agreement between the EG and the community pharmacists was calculated. Internal agreement in the EG was calculated using a modified version of Fleiss’ Kappa coefficient. Results: a total of 73 patients were included (mean age 62 years, 52% female, on average prescribed 8.7 drugs). The pharmacists identified 88 DRPs in 43 of the patients. The most common DRPs were adverse drug reactions (22%) and wrong drug or dose used by patient (14%). Anti-diabetic drugs and lipid modifying drugs were associated with the most DRPs. The EG agreed with detection and categorisation of DRPs in more than 80% of the cases. The clinical/practical relevance of the detected DRPs was scored by the EG to be high or medium in 87% of the cases. The quality of the follow-up with patients and physicians was scored to be good or satisfactory in 93 and 98% of the cases, respectively. Conclusions: pre-defined categories of DRPs supported by structured forms were reliable and valid tools for identifying DRPs. The evaluation demonstrated that community pharmacists were able to identify DRPs of high to medium clinical/practical relevance, and to perform follow-ups of the DRPs with the patients and the physicians with a good or satisfactory quality