Translation and validation of the Norwegian version of the postoperative quality of recovery score QoR-15.

BACKGROUND: As patient-centered care gains more attention, assessing the patient's perspective on their recovery has become increasingly important. In response to the need for a reliable and valid patient reported outcome measurement tool for major surgical resections in Norway. The Norwegian Registry for Gastrointestinal Surgery (NORGAST) initiated a project to translate and evaluate QoR-15's psychometric properties for patients going through general, gastrointestinal (GI), and hepato-pancreato-biliary (HPB) resectional surgery. METHODS: After a translation and adaption of the original version of QoR-15 into Norwegian, the QoR-15NO was psychometrically evaluated including a confirmatory factor analysis to test for unidimensionality, as well as tests for content validity, internal consistency, measurement error, construct validity, feasibility, and responsiveness. This process included cognitive interviews using a structured interview guide. Further, patients who underwent various types of GI/HPB surgery at five hospitals in different parts of Norway completed the QoR-15NO before surgery and on the first or second day after surgery. The impact of surgery was classified according to Surgical Outcome Risk Tool v2 (SORT), in extra major/complex, major, intermediate, and minor. RESULTS: This study included 324 patients with 83% return rate with both pre- and postoperative forms. There were negative correlations between duration of surgery and postoperative QoR-15 score and the difference between post- and preoperative score (change score). Individuals who had gone through surgery with major impact had a lower postoperative mean QoR-15 score (97) than their counterparts who had experienced either medium (QoR-15: 110) or minor (QoR15: 119) impact surgery. Cronbach's alpha (0.88) and Omega Alpha Total (ωt = 0.90) indicate that the scale has good to very good internal consistency. Test-retest reliability was measured by Intra-class Correlation Coefficient to ICC = 0.70. Confirmatory factor analyses supported that a one-factor model with correlated residuals had a good fit to data. CONCLUSION: This study supports QoR-15NO as a valid, essentially unidimensional, feasible, and responsive instrument among patients undergoing general, GI, and HPB resectional surgery in Norway. The total QoR-15NO score provides important information that can be used in an everyday clinical setting and integrated into NORGAST.

A Trial-Based Cost-Utility Analysis of a Medication Optimization Intervention Versus Standard Care in Older Adults.

BACKGROUND: Older adults are at greater risk of medication-related harm than younger adults. The Integrated Medication Management model is an interdisciplinary method aiming to optimize medication therapy and improve patient outcomes. OBJECTIVE: We aimed to investigate the cost effectiveness of a medication optimization intervention compared to standard care in acutely hospitalized older adults. METHODS: A cost-utility analysis including 285 adults aged ≥ 70 years was carried out alongside the IMMENSE study. Quality-adjusted life years (QALYs) were derived using the EuroQol 5-Dimension 3-Level Health State Questionnaire (EQ-5D-3L). Patient-level data for healthcare use and costs were obtained from administrative registers, taking a healthcare perspective. The incremental cost-effectiveness ratio was estimated for a 12-month follow-up and compared to a societal willingness-to-pay range of €/QALY 27,067-81,200 (NOK 275,000-825,000). Because of a capacity issue in a primary care resulting in extended hospital stays, a subgroup analysis was carried out for non-long and long stayers with hospitalizations < 14 days or ≥ 14 days. RESULTS: Mean QALYs were 0.023 [95% confidence interval [CI] 0.022-0.025] higher and mean healthcare costs were €4429 [95% CI - 1101 to 11,926] higher for the intervention group in a full population analysis. This produced an incremental cost-effectiveness ratio of €192,565/QALY. For the subgroup analysis, mean QALYs were 0.067 [95% CI 0.066-0.070, n = 222] and - 0.101 [95% CI - 0.035 to 0.048, n = 63] for the intervention group in the non-long stayers and long stayers, respectively. Corresponding mean costs were €- 824 [95% CI - 3869 to 2066] and €1992 [95% CI - 17,964 to 18,811], respectively. The intervention dominated standard care for the non-long stayers with a probability of cost effectiveness of 93.1-99.2% for the whole willingness-to-pay range and 67.8% at a zero willingness to pay. Hospitalizations were the main cost driver, and readmissions contributed the most to the cost difference between the groups. CONCLUSIONS: According to societal willingness-to-pay thresholds, the medication optimization intervention was not cost effective compared to standard care for the full population. The intervention dominated standard care for the non-long stayers, with a high probability of cost effectiveness. CLINICAL TRIAL REGISTRATION: The IMMENSE trial was registered in ClinicalTrials.gov on 28 June, 2016 before enrolment started (NCT02816086).

Is anticholinergic and sedative drug burden associated with postdischarge institutionalization in community-dwelling older patients acutely admitted to hospital? A Norwegian registry-based study.

PURPOSE: Investigate the association between anticholinergic (AC) and sedative (SED) drug burden before hospitalization and postdischarge institutionalization (PDI) in community-dwelling older patients acutely admitted to hospital. METHODS: A cross-sectional study using data from the Norwegian Patient Registry and the Norwegian Prescription Database. We studied acutely hospitalized community-dwelling patients ≥70 years during 2013 (N = 86 509). Patients acutely admitted to geriatric wards underwent subgroup analyses (n = 1715). We calculated drug burden by the Drug Burden Index (DBI), use of AC/SED drugs, and the number of AC/SED drugs. Piecewise linearity of DBI versus PDI and a knot point (DBI = 2.45) was identified. Statistical analyses included an adjusted multivariable logistic regression model. RESULTS: In the total population, 45.4% were exposed to at least one AC/SED drug, compared to 52.5% in the geriatric subgroup. AC/SED drugs were significantly associated with PDI. The DBI with odds ratios (ORs) of 1.11 (95% CI 1.07-1.15) for DBI < 2.45 and 1.08 (95% CI 1.04-1.13) for DBI ≥ 2.45. The number of AC/SED drugs with OR of 1.07 (95% CI 1.05-1.09). The AC component of DBI with OR 1.23 and the number of AC drugs with OR 1.13. In the subgroup, ORs were closer to 1 for AC drugs. CONCLUSIONS: The use of AC/SED drugs was highly prevalent in older patients before acute hospital admissions, and significantly associated with PDI. The number, or just using AC/SED drugs, gave similar associations with PDI compared to applying the DBI. Using AC drugs showed higher sensitivity, indicating that to reduce the risk of PDI, a clinical approach could be to reduce the number of AC drugs.

Interdisciplinary collaboration across secondary and primary care to improve medication safety in the elderly (The IMMENSE study) - a randomized controlled trial.

BACKGROUND: Suboptimal medication use contributes to a substantial proportion of hospitalizations and emergency department visits in older adults. We designed a clinical pharmacist intervention to optimize medication therapy in older hospitalized patients. Based on the integrated medicine management (IMM) model, the 5-step IMMENSE intervention comprise medication reconciliation, medication review, reconciled medication list upon discharge, patient counselling, and post discharge communication with primary care. The objective of this study was to evaluate the effects of the intervention on healthcare use and mortality. METHODS: A non-blinded parallel group randomized controlled trial was conducted in two internal medicine wards at the University Hospital of North Norway. Acutely admitted patients ≥ 70 years were randomized 1:1 to intervention or standard care (control). The primary outcome was the rate of emergency medical visits (readmissions and emergency department visits) 12 months after discharge. RESULTS: Of the 1510 patients assessed for eligibility, 662 patients were asked to participate, and 516 were enrolled. After withdrawal of consent and deaths in hospital, the modified intention-to-treat population comprised 480 patients with a mean age of 83.1 years (SD: 6.3); 244 intervention patients and 236 control patients. The number of emergency medical visits in the intervention and control group was 497 and 499, respectively, and no statistically significant difference was observed in rate of the primary outcome between the groups [adjusted incidence rate ratio of 1.02 (95% CI: 0.82-1.27)]. No statistically significant differences between groups were observed for any of the secondary outcomes, neither in subgroups, nor for the per-protocol population. CONCLUSIONS: We did not observe any statistical significant effects of the IMMENSE intervention on the rate of emergency medical visits or any other secondary outcomes after 12 months in hospitalized older adults included in this study. TRIAL REGISTRATION: The trial was registered in clinicaltrials.gov on 28/06/2016, before enrolment started (NCT02816086).

Intervention fidelity and process outcomes of the IMMENSE study, a pharmacist-led interdisciplinary intervention to improve medication safety in older hospitalized patients.

WHAT IS KNOWN AND OBJECTIVE: The majority of hospitalized older patients experience medication-related problems (MRPs), and there is a call for interventions to solve MRPs and improve clinical outcomes like medical visits. The IMMENSE study is a randomized controlled trial investigating the impact of a pharmacist-led interdisciplinary intervention on emergency medical visits. Its multistep intervention is based on the integrated medicines management methodology and includes a follow-up step with primary care. This study aims to describe how the intervention in the IMMENSE study was delivered and its process outcomes. METHODS: The study includes the 221 intervention patients in the per-protocol group of the IMMENSE study. Both intervention delivery, reasons for not performing interventions and process outcomes were registered daily by the study pharmacists in a Microsoft Access® database. Process outcomes were medication discrepancies, MRPs and how the team solved these. RESULTS AND DISCUSSION: A total of 121 (54.8%) patients received all intervention steps if appropriate. All patients received medication reconciliation (MedRec) and medication Review (MedRev) (step 1 and 2), while between 10% and 20% of patients were missed for medication list in discharge summary (step 3), patient counselling (step 4), or communication with general practitioner and nurse (step 5). A total of 437 discrepancies were identified in 159 (71.9%) patients during MedRec, and 1042 MRPs were identified in 209 (94.6%) patients during MedRev. Of these, 292 (66.8%) and 700 (67.2%), respectively, were communicated to and solved by the interdisciplinary team during the hospital stay. WHAT IS NEW AND CONCLUSION: The fidelity of the single steps of the intervention was high even though only about half of the patients received all intervention steps. The impact of the intervention may be influenced by not implementing all steps in all patients, but the many discrepancies and MRPs identified and solved for the patients could explain a potential effect of the IMMENSE study.

Time distribution for pharmacists conducting a randomized controlled trial-An observational time and motion study.

INTRODUCTION: An expected future increase in older adults will demand changes in health care delivery, making development, implementation and evaluation of new health care models essential. The rationale for political decision-making concerning the implementation and application of interventions in health care should include cost estimations, specifically those involving clinical interventions. To provide such data knowledge of time spent on the intervention is imperative. Time and motion methodology is suitable to quantify health care personnel's time distribution. AIM: To investigate the time distribution for pharmacists conducting a randomized controlled trial (RCT) implementing a clinical intervention. MATERIALS AND METHODS: The setting was an RCT with a 5-step pharmacist-intervention in collaboration with the interdisciplinary team in a geriatric ward. Two pharmacists were involved in the trial during the observation period. Pharmacist activities, classified as RCT-tasks (intervention or administrative), non-RCT tasks and social/breaks, were recorded applying the Work Observation Method By Activity Timing methodology, enabling recording of predefined work tasks as well as interruptions and multitasking. One observer collected data over eight weeks. RESULTS: In total, 109.1 hours were observed resulting in 110.2 hours total task time, including multitasking. RCT tasks comprised 85.4% of the total observed time, and nearly 60% of the RCT time was spent on intervention tasks. Medication reviews was the most time consuming task, accounting for 32% of the observed time. The clinical pharmacists spent 14% of the intervention time communicating verbally, mainly with patients and healthcare professionals. CONCLUSION: During the RCT, the clinical pharmacists spent about half their time performing the actual intervention. Consequently, costs for providing such a clinical pharmacist service should reflect actual time spent; otherwise, we may risk overestimating theoretical costs.

The impact of hospitalisation to geriatric wards on the use of medications and potentially inappropriate medications - a health register study.

BACKGROUND: The use of potentially inappropriate medications (PIMs) are associated with negative health effects for older adults. The purpose of this study was to apply national register data to investigate the impact of hospitalisation to geriatric wards in Norway on the use of medications and PIMs, and to compare two explicit PIM identification tools. METHODS: We included 715 patients ≥65 years (mean 82.5, SD = 7.8) admitted to Norwegian geriatric wards in 2013 identified from The Norwegian Patient Registry, and collected their medication use from the Norwegian Prescription Database. Medication use before and after hospitalisation was compared and screened for PIMs applying a subset of the European Union (EU)(7)-PIM list and the Norwegian General Practice - Nursing Home (NORGEP-NH) list part A and B. RESULTS: The mean number of medications increased from 6.5 (SD = 3.5) before to 7.5 (SD = 3.5) (CI:1.2-0.8, p < 0.001) after hospitalisation. The proportion of patients with PIMs increased from before to after hospitalisation according to the EU(7)-PIM list (from 62.4 to 69.2%, p < 0.001), but not according to The NORGEP-NH list (from 49.9 to 50.6%, p = 0.73). The EU(7)-PIM list and the NORGEP-NH list had more than 70% agreement on the classification of patients as PIM users. CONCLUSIONS: Medication use increased after hospitalisation to geriatric wards. We did not find that geriatric hospital care leads to a general improvement in PIM use after hospitalisation. According to a subset of the EU(7)-PIM list, PIM use increased after hospitalisation. This increase was not identified by the NORGEP-NH list part A and B. It is feasible to use health register data to investigate the impact of hospitalisation to geriatric wards on medication use and PIMs.

Interdisciplinary collaboration across secondary and primary care to improve medication safety in the elderly (IMMENSE study): study protocol for a randomised controlled trial.

INTRODUCTION: Drug-related problems (DRPs) are common in the elderly, leading to suboptimal therapy, hospitalisations and increased mortality. The integrated medicines management (IMM) model is a multifactorial interdisciplinary methodology aiming to optimise individual medication therapy throughout the hospital stay. IMM has been shown to reduce readmissions and drug-related hospital readmissions. Using the IMM model as a template, we have designed an intervention aiming both to improve medication safety in hospitals, and communication across the secondary and primary care interface. This paper presents the study protocol to explore the effects of the intervention with regard to healthcare use, health-related quality of life (HRQoL) and medication appropriateness in elderly patients. METHODS AND ANALYSIS: A total of 500 patients aged ≥70 years will be included and randomised to control (standard care) or intervention group (1:1). The intervention comprises five steps mainly performed by pharmacists: (1) medication reconciliation at admission, (2) medication review during hospital stay, (3) patient counselling about the use of medicines, (4) a comprehensible and patient-friendly medication list with explanations in discharge summary and (5) postdischarge phone calls to the primary care level. The primary outcome is the difference between intervention and control patients in the rate of emergency medical visits (acute readmissions and visits to emergency department) 12 months after discharge. Secondary outcomes include length of index hospital stay, time to first readmission, mortality, hip fractures, strokes, medication changes, HRQoL and medication appropriateness. Patient inclusion started in September 2016. ETHICS AND DISSEMINATION: The trial was approved by the Norwegian Centre for Research Data and the Norwegian Data Protection Authority. We aim to publish the results in international peer-reviewed open access journals, at national and international conferences, and as part of two PhD theses. TRIAL REGISTRATION NUMBER: NCT02816086.

No change in insulin sensitivity in renal transplant recipients converted from standard to once-daily prolonged release tacrolimus.

BACKGROUND: New-onset diabetes after transplantation may be associated with the use of tacrolimus (Tac) causing impaired insulin release or reduced insulin sensitivity. Such effects have not been studied in renal transplant recipients receiving traditional twice-daily tacrolimus (TacBID) and then compared to the new once-daily prolonged release formulation of tacrolimus (TacOD). METHODS: We performed a prospective crossover study of 20 stable non-diabetic renal transplant recipients. All patients underwent one hyperglycaemic clamp on TacBID (3.8 ± 2.2 mg/day) and a new clamp 4-6 weeks after a 1:1 mg/day switch to TacOD (4.0 ± 2.8 mg/day). RESULTS: Tac trough concentrations decreased from 6.6 ± 2.9 to 5.4 ± 1.4 µg/mL (P = 0.037) and Tac max from 21.3 ± 8.4 to 15.2 ± 3.5 µg/L (P = 0.001). Tac AUC(0-24) was reduced from 265 ± 112 to 218 ± 47 µg × h/L (P = 0.12). The hyperglycaemic clamp did not detect any change in insulin sensitivity index after conversion [0.26 ± 0.21 versus 0.26 ± 0.25 µmol/min/kg/(pmol/L insulin), P = 0.99] nor any change in first (334 ± 274 versus 353 ± 248 µIU × min/mL, P = 0.41) or second phase insulin secretion (224 ± 155 versus 263 ± 210 µIU × min/mL/mmol glucose, P = 0.60) on TacBID versus TacOD. CONCLUSIONS: Conversion from standard TacBID to TacOD on a 1:1 mg basis is safe. In spite of a reduced Tac exposure, there was no change in insulin release or sensitivity in renal transplant recipients.