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Drug-Associated Risk Tool: development and validation of a self-assessment questionnaire to screen for hospitalised patients at risk for drug-related problems.

ABSTRACT: INTRODUCTION:Identifying patients with a high risk for drug-related problems (DRPs) might optimise the allocation of targeted pharmaceutical care during the hospital stay and on discharge. OBJECTIVE:To develop a self-assessment screening tool to identify patients at risk for DRPs and validate the tool regarding feasibility, acceptability and the reliability of the patients' answers. DESIGN:Prospective validation study. SETTING:Two mid-sized hospitals (300-400 beds). PARTICIPANTS:195 patients, exclusion criteria: under 18 years old, patients with a health status not allowing a meaningful communication (eg, delirium, acute psychosis, advanced dementia, aphasia, clouded consciousness state), palliative or terminally ill patients. METHODS:Twenty-seven risk factors for the development of DRPs, identified in a previous study, provided the basis of the self-assessment questionnaire, the Drug-Associated Risk Tool (DART). Consenting patients filled in DART, and we compared their answers with objective patient data from medical records and laboratory data. RESULTS:One hundred and sixty-four patients filled in DART V.1.0 in an average time of 7?min. After a first validation, we identified statements with a low sensitivity and revised the wording of the questions related to heart insufficiency, renal impairment or liver impairment. The revised DART (V.2.0) was validated in 31 patients presenting heart insufficiency, renal impairment or liver impairment as comorbidity and reached an average specificity of 88% (range 27-100) and an average sensitivity of 67% (range 21-100). CONCLUSIONS:DART showed a satisfying feasibility and reliability. The specificity of the statements was mostly high. The sensitivity varied and was higher in statements concerning diseases that require regular disease control and attention to self-care and drug management. Asking patients about their conditions, medications and related problems can facilitate getting a first, broad picture of the risk for DRPs and possible pharmaceutical needs.

SUBMITTER: Kaufmann CP

PROVIDER: S-EPMC5855403 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature

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Project description:ObjectivesThe Drug-Associated Risk Tool (DART) has been developed as a self-administered questionnaire for patients with the aim of stratifying patients according to their risk of drug-related problems (DRPs). We aimed to validate the ability of the questionnaire to distinguish between hospitalised patients showing lower and higher numbers of DRPs.DesignCross-sectional study assessing the questionnaire's concurrent criterion validity.SettingFive geriatric and the associated physical and neurological rehabilitation wards of a Swiss regional secondary care hospital with 617 beds.ParticipantsWe recruited 110 patients from a total of 437 admissions. Exclusion criteria were insufficient knowledge in spoken or written German, medical conditions preventing meaningful conversations and already receiving pharmacy services.InterventionsComprehensive pharmacist-led clinical medication reviews were performed, including patient interviews, to identify potential and manifest DRPs. A cluster analysis was conducted to assess the discriminatory potential of the DART to group patients according to number (low and high) of identified DRPs. A subsequent discriminatory function analysis was performed to reduce the number of items. We determined which DART items may be used to trigger what type of medication review.ResultsRecruited patients had a median age of 79 years and were prescribed a median of 11 drugs. Patients with a median DART score of 10 and a median of 3 DRPs represented one cluster, whereas patients with a median DART score of 15 and a median of 8 DRPs represented another cluster. Discriminatory function analysis reduced the questionnaire to five items with a moderate to strong correlation with the number of DRPs per patient (Spearman's rank correlation ?=0.44). Additional items were associated with patients benefiting from interviews.ConclusionsAs a self-administered questionnaire for patients, the DART may be used to stratify hospitalised non-acute older patients in groups of having low and high likelihood of DRPs. The analyses showed that a short form of the DART can be used instead of the full tool to identify older inpatients at risk for DRPs. Additional eight items from the DART may be used to initiate additional clinical pharmacy services. The linkage between certain DART questions and type of medication review enables pharmacist resource allocation.

Project description:BACKGROUND: Subcutaneous self-injection of medication has benefits for the patient and healthcare system, but there are barriers such as dexterity problems and injection anxiety that can prevent self-injection being used effectively. An accurate method of evaluating patients' experiences with self-injection would enable assessment of their success in giving self-injections and the likelihood of them adhering to a self-injection regimen. The aim of this study was to develop a questionnaire to measure overall patient experience with subcutaneous self-injection (the Self-Injection Assessment Questionnaire [SIAQ]), and to investigate its psychometric properties. METHODS: The construct validity and reliability of the SIAQ were tested in patients with rheumatoid arthritis who volunteered to inject certolizumab pegol using a standard syringe during an open-label multinational extension trial of the long-term safety and efficacy of this drug. The SIAQ PRE module was self-completed before the first self-injection, and the POST module was self-completed following each of three fortnightly self-injections. RESULTS: Ninety-seven patients completed the SIAQ. All items correlated well with their respective domains in confirmatory factor analysis. As predicted, compared with other participants, patients with very low scores (less than 3 out of 10) in PRE causal domains (Feelings about injections and Self-confidence) were significantly less satisfied with their first self-injection, as were patients with a very low score in any POST causal domain (Self-confidence, Feelings about injections, Injection-site reactions and Ease of use), demonstrating known-groups validity. Causal domain scores generally correlated most strongly with the Satisfaction with self-injection domain, supporting convergent validity. The SIAQ demonstrated internal consistency and reproducibility; Cronbach's ? and the test-retest coefficient were > 0.70 for all domains. Sensitivity and responsiveness were also shown, where measurable. Each language version showed structural validity. CONCLUSION: The SIAQ was demonstrated to be a valid, reliable tool in patients with rheumatoid arthritis.

Project description:Background: Drug overdoses (fatal and non-fatal) are among the leading causes of death in population with substance use disorders. The aim of the current study was to identify risk factors for fatal and non-fatal drug overdose for predominantly opioid-dependent treatment-seeking population. Methods: Data were collected from 640 adult patients using a self-reported 25-item Overdose Risk (OdRi) questionnaire pertaining to drug use and identified related domains. The exploratory factor analysis (EFA) was primarily used to improve the interpretability of this questionnaire. Two sets of EFA were conducted; in the first set of analysis, all items were included, while in the second set, items related to the experience of overdose were removed. Logistic regression was used for the assessment of latent factors' association with both fatal and non-fatal overdoses. Results: EFA suggested a three-factor solution accounting for 75 and 97% of the variance for items treated in the first and second sets of analysis, respectively. Factor 1 was common for both sets of EFA analysis, containing six items (Cronbach's α = 0.70) focusing around "illicit drug use and lack of treatment." In the first set of analysis, Factors 2 (Cronbach's α = 0.60) and 3 (Cronbach's α = 0.34) were focusing around "mental health and emotional trauma" and "chronic drug use and frequent overdose" domains, respectively. The increase of Factor 2 was found to be a risk factor for fatal drug overdose (adjusted coefficient = 1.94, p = 0.038). In the second set of analysis, Factors 2 (Cronbach's α = 0.65) and 3 (Cronbach's α = 0.59) as well as Factor 1 were found to be risk factors for non-fatal drug overdose ever occurring. Only Factors 1 and 3 were positively associated with non-fatal overdose (one in a past year). Conclusion: The OdRi tool developed here could be helpful for clinical studies for the overdose risk assessment. However, integrating validated tools for mental health can probably help refining the accuracy of latent variables and the questionnaire's consistency. Mental health and life stress appear as important predictors of both fatal and non-fatal overdoses.

Project description:BackgroundChild and adolescent mental health problems are urgent health issues in low- and middle-income countries. To promote child and adolescent mental health services, simple validated screening tools are helpful. In Mongolia, the Strengths and Difficulties Questionnaire (SDQ), an internationally used child and adolescent mental health screening tool for children aged 4-17, was translated but not yet validated. To use the questionnaire appropriately, validation is necessary.MethodsChildren at 4th year at elementary school (community sample) and children visited psychiatric outpatient service (clinical sample) were recruited and their parental version of the SDQ was compared. The discriminating ability of the parental version of the SDQ was examined using Receiver Operating Characteristics (ROC) analysis on the SDQ total difficulties score. The area under the ROC curve (AUC) was used as a measure. Cut-off score was determined by normative banding that categorizes children with the highest 10% score range as abnormal and the second highest 10% as borderline following the original method; this cut-off score was compared with the cut-off score candidates with good balance between sensitivity and specificity using ROC analysis.ResultsWe included 2301 children in the community sample, and 429 children in the clinical sample. Mean age was 9.7 years (SD 0.4, range 8.3-12.0) among the community sample and 10.4 years (SD 3.8, range 4.0-17.8) among the clinical sample. The mean total difficulties score was 12.9 (SD 4.8) among the community sample and 20.4 (SD 6.2) among the clinical sample. A total of 88.8% of the community sample and 98.8% of the clinical sample answered the SDQ. Using ROC analysis, the AUC was 0.82 (95% confident interval 0.80-0.85), which meant moderate discriminating ability. Using normative banding, the borderline cut-off score was 16/17 and abnormal cut-off score was 19/20. For cut-off scores of 16/17 and 19/20, sensitivity was 71.9 and 53.8% and specificity was 78.5 and 90.5%, respectively. The cut-off score candidates by ROC analysis were 16/17 and 17/18.ConclusionsThe parental version of the SDQ had moderate discriminating ability among Mongolian school-age children. For the screening of mental health problems among community children, cut-off score of 16/17 is recommended.

Project description:BACKGROUND:Patient-reported outcome (PRO) instruments provide robust and effective means of evaluating patients' treatment experience; however, none adequately cover experience using self-injection devices with enhanced features, such as an electromechanical autoinjector (e-Device). The aim of this study was to develop a PRO instrument that accurately assesses patient experience of using an e-Device and to evaluate its psychometric properties. METHODS:A mixed-methods approach was taken; two parallel, targeted literature reviews were conducted to identify relevant concepts and existing self-injection PRO instruments that could be adapted. Patient feedback obtained from two focus groups was used to inform initial instrument development. The pilot instrument was then administered in a multicenter, open-label, phase 3 clinical study in which patients self-injected certolizumab pegol using an e-Device, to gather evidence of its psychometric qualities. Exit interviews were conducted with a sub-sample of patients enrolled in the study to confirm the appropriateness and clarity of the items included and cognitively debrief the instrument. Confirmatory factor analysis (CFA) was conducted on all items, and each domain's internal consistency was measured using Cronbach's ?. RESULTS:The literature searches identified several e-Device-specific concepts related to device features, device function, side effects/reactions/pain, confidence, and interference/convenience in daily life. Seven existing PRO instruments were identified. The Self-Injection Assessment Questionnaire (SIAQ), containing pre- and post-injection questionnaire modules, was selected as most suitable and adapted using feedback from 19 patients in the two focus groups to form the pilot Assessment of Self-Injection (ASI) questionnaire. CFA resulted in some changes to the grouping of items in the post-injection module domains following psychometric evaluation of the ASI. Internal consistency was satisfactory for all pre- and post-injection domains (??>?0.8). Cognitive debriefing results from 12 patient exit interviews confirmed the ASI's appropriateness and clarity. CONCLUSIONS:The ASI was developed iteratively with patient input and was evaluated in its intended clinical context of use. Psychometric analyses indicated promising cross-sectional results; the ASI was well understood and considered relevant by patients self-injecting using the e-Device, suggesting that it could be used in real-world settings to aid with clinical decision making. TRIAL REGISTRATION:NCT03357471.

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Drug-Associated Risk Tool: development and validation of a self-assessment questionnaire to screen for hospitalised patients at risk for drug-related problems.

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