scholarly journals Unlicensed medicines use: a UK guideline analysis using AGREE II

2018 ◽  
Vol 26 (6) ◽  
pp. 515-525 ◽  
Author(s):  
Gemma Donovan ◽  
Lindsay Parkin ◽  
Lyn Brierley-Jones ◽  
Scott Wilkes
Keyword(s):  
Agree Ii ◽  
Unlicensed Medicines ◽  
Medicines Use

scholarly journals A study of off-label and unlicensed medicines use in neonatal units

2016 ◽  
Vol 62 (2) ◽  
pp. 65-72
Author(s):  
Elizabeta Zisovska ◽  
Blerina Koshi ◽  
Renata Slaveska-Raichki
Keyword(s):  
Off Label Use ◽  
Medicine Use ◽  
Off Label ◽  
Unlicensed Medicines ◽  
Gynecology And Obstetrics ◽  
Life Saving ◽  
Medicines Use ◽  
High Level ◽  
Evidence Based Guidelines ◽  
Label Use

Despite all efforts to improve the on-label use of licensed medicines for neonates, there is still high percentage and demands of offlabel and unlicensed medicines use in neonatal therapy. Therefore, the general objective of this survey is to provide a description of off-label and unlicensed medicines use within the neonatal therapeutic areas in a Department of Neonatology, University Clinic for Gynecology and Obstetrics, in Skopje, Republic of Macedonia. All analyzed prescriptions were given in accordance with the Evidence Based Guidelines applied in the Department. During the three months’ period in 2015, there were given 1595 prescriptions, comprising 3.99 prescriptions per newborn during the hospital stay. Out of them, 532 (33.3%) were on-label medicine uses, 1052 (66%) were off-label medicines, and 11 prescriptions (0.7%) were unlicensed medicines. The results from this study show the high level of off-label medicine use in neonatal therapy. These results present only the “top of the iceberg” and require more comprehensive analysis that will gradually evolve in a National Guideline on off-label use areas in pediatric medicine, especially for critically ill newborns who are prescribed much more life-saving medicines.

scholarly journals Evaluation of clinical practice guidelines (CPG) on the management of female chronic pelvic pain (CPP) using the AGREE II instrument

2021 ◽  
Author(s):  
Vishalli Ghai ◽  
Venkatesh Subramanian ◽  
Haider Jan ◽  
Jemina Loganathan ◽  
Stergios K. Doumouchtsis ◽  
...  
Keyword(s):  
Surgical Management ◽  
Guideline Development ◽  
Stakeholder Involvement ◽  
Professional Organizations ◽  
Agree Ii ◽  
Behavioural Interventions ◽  
Recommended Treatment ◽  
Muscular Dysfunction ◽  
Health Related

Abstract Introduction and hypothesis Variations in guidelines may result in differences in treatments and potentially poorer health-related outcomes. We aimed to systematically review and evaluate the quality of national and international guidelines and create an inventory of CPG recommendations on CPP. Methods We searched EMBASE and MEDLINE databases from inception till August 2020 as well as websites of professional organizations and societies. We selected national and international CPGs reporting on the diagnosis and management of female CPP. We included six CPGs. Five researchers independently assessed the quality of included guidelines using the AGREE II tool and extracted recommendations. Results Two hundred thirty-two recommendations were recorded and grouped into six categories: diagnosis, medical treatment, surgical management, behavioural interventions, complementary/alternative therapies and education/research. Thirty-nine (17.11%) recommendations were comparable including: a comprehensive pain history, a multi-disciplinary approach, attributing muscular dysfunction as a cause of CPP and an assessment of quality of life. Two guidelines acknowledged sexual dysfunction associated with CPP and recommended treatment with pelvic floor exercises and behavioural interventions. All guidelines recommended surgical management; however, there was no consensus regarding adhesiolysis, bilateral salpingo-oophorectomy during hysterectomy, neurectomy and laparoscopic uterosacral nerve ablation. Half of recommendations (106, 46.49%) were unreferenced or made in absence of good-quality evidence or supported by expert opinion. Based on the AGREE II assessment, two guidelines were graded as high quality and recommended without modifications (EAU and RCOG). Guidelines performed poorly in the “Applicability”, “Editorial Independence” and “Stakeholder Involvement” domains. Conclusion Majority of guidelines were of moderate quality with significant variation in recommendations and quality of guideline development.

scholarly journals Integrating approaches for quality guideline development in LactaMap, an online lactation care support system

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Melinda Boss ◽  
Jennifer Turner ◽  
Patrick Boss ◽  
Peter Hartmann ◽  
Douglas Pritchard ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Clinical Practice Guidelines ◽  
Support System ◽  
Practice Guidelines ◽  
Common Sense ◽  
Guideline Development ◽  
Phase 1 ◽  
Domain Score ◽  
Agree Ii ◽  
Care Support

Abstract Background Health professionals caring for women and infants experiencing difficulty with breastfeeding have reported deficiencies in evidence-based lactation knowledge. LactaMap is an online lactation care support system with more than 100 clinical practice guidelines to support breastfeeding care. Clinical practice guidelines support medical decision-making by summarising scientific evidence into systematically developed statements for specific clinical circumstances. Both common-sense and theory-based approaches have been used for guideline development and debate continues regarding which is superior. LactaMap clinical practice guidelines were created over the course of 5 years using a common-sense approach that was refined inductively. The aim of this study was to incorporate a theory-based framework approach into the methodology for ongoing update and review of LactaMap clinical practice guidelines. Methods The Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument was chosen as the framework-based approach to appraise LactaMap guideline quality. The study was conducted in two phases. The first phase appraised all 103 original LactaMap guidelines. The second phase appraised a subset of 15 updated LactaMap guidelines using improved methodology guided by phase 1, as well as 15 corresponding original (un-updated) guidelines. Results Mean Domain scores for 103 LactaMap original guidelines were above 75% in 3 of the 6 AGREE II quality Domains and no mean Domain score rated poorly. Update of guideline methodology was guided by phase 1 appraisals. Improved documentation of methods relating to questions in the Rigour of Development Domain resulted in improvement in mean Domain score from 39 to 72%. Conclusions This study showed that a theory-based approach to guideline development methodology can be readily integrated with a common-sense approach. Factors identified by AGREE II theory-based framework provided practical guidance for changes in methodology that were integrated prior to LactaMap website publication. Demonstration of high quality in LactaMap clinical practice guideline methodology ensures clinicians and the public can have trust that the content founded on them is robust, scientific and of highest possible quality.

scholarly journals EAU, AUA and NICE Guidelines on Surgical and Minimally Invasive Treatment of Benign Prostate Hyperplasia: A Critical Appraisal of the Guidelines Using the AGREE-II Tool

2021 ◽  
pp. 1-10
Author(s):  
Dmitry Enikeev ◽  
Vincent Misrai ◽  
Enrique Rijo ◽  
Roman Sukhanov ◽  
Denis Chinenov ◽  
...  
Keyword(s):  
Minimally Invasive ◽  
Treatment Options ◽  
Stakeholder Involvement ◽  
Minimally Invasive Treatment ◽  
Invasive Treatment ◽  
Agree Ii ◽  
Prostate Hyperplasia ◽  
Assessment Score ◽  
Nice Guideline ◽  
Agree Ii Tool

<b><i>Objective:</i></b> To critically appraise the methodological rigour of the clinical practice guidelines (CPGs) vis-à-vis BPH surgery as used by specialist research associations in the US, Europe and UK, and to compare whether the guidelines cover all or only some of the available treatments. <b><i>Methods:</i></b> The current guidelines issued by the EUA, AUA and NICE associations have been analyzed by 4 appraisers using the AGREE-II instrument. We also compared the recommendations given in the guidelines for surgical and minimally invasive treatment to find out which of these CPGs include most of the available treatment options. <b><i>Results:</i></b> According to the AGREE II tool, the median scores of domains were: domain 1 scope and purpose 66.7%, domain 2 stakeholder involvement 50.0%, domain 3 rigor of development 65.1%, domain 4 clarity of presentation 80.6%, domain 5 applicability 33.3%, domain 6 editorial independence 72.9%. The overall assessment according to AGREE II is 83.3%. The NICE guideline scored highest on 5 out of 6 domains and the highest overall assessment score (91.6%). The EAU guideline scored lowest on 4 out of 6 domains and has the lowest overall assessment score (79.1%). <b><i>Conclusions:</i></b> The analyzed CPGs comprehensively highlight the minimally invasive and surgical treatment options for BPH. According to the AGREE II tool, the domains for clarity of presentation and editorial independence received the highest scores. The stakeholder involvement and applicability domains were ranked as the lowest. Improving the CPG in these domains may help to improve the clinical utility and applicability of CPGs.

scholarly journals Improved adherence with Medicines Use Review service in Slovenia: a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Urška Nabergoj Makovec ◽  
Igor Locatelli ◽  
Mitja Kos
Keyword(s):  
Medication Adherence ◽  
Controlled Trial ◽  
Test Group ◽  
Multiple Linear Regression Model ◽  
Relative Difference ◽  
Control Group ◽  
Adherence Support ◽  
Medicines Use ◽  
The Impact ◽  
Medicines Use Review

Abstract Background Based on several existing patient-oriented activities, Medicines Use Review (MUR) service was standardized and officially adopted in Slovenia in 2015. Service aims to provide adherence support and ensure safe and effective medicines use. Therefore, the aim of the study was to evaluate the benefits of MUR in Slovenia, primarily the impact on medication adherence. Methods A randomised controlled trial was performed in community pharmacies to compare MUR with standard care. Patients were randomised into either the test (patients received MUR by a certified MUR provider at visit 1), or control group. The study primary outcome was self-reported adherence to multiple medications, assessed by electronic ©Morisky Widget MMAS-8 Software at the first visit (V1) and after 12 weeks (V2). A sub-analysis of intentional and unintentional non-adherence was performed. MUR impact was defined as the relative difference in ©MMAS-8 score after 12 weeks between the test and control group. A multiple linear regression model was used to predict MUR impact based on baseline adherence (low versus medium and high). Several secondary outcomes (e.g. evaluation of drug-related problems (DRPs)) were also assessed. Results Data from 153 (V1) and 140 (V2) patients were analysed. Baseline adherence was low, moderate and high in 17.6, 48.4 and 34.0% patients, respectively. In the low adherence subpopulation, test group patients showed a 1.20 point (95% CI = 0.16–2.25) increase in total ©MMAS-8 score (p = 0.025) compared to control group patients. A 0.84 point (95% CI = 0.05–1.63) increase was due to intentional non-adherence (p = 0.038), and a 0.36 point (95% CI = − 0.23-0.95) was due to unintentional non-adherence (p = 0.226). Additionally, statistically significant decrease in the proportion of patients with manifested DRPs (p < 0.001) and concerns regarding chronic medicines use (p = 0.029) were revealed. Conclusion MUR service in Slovenia improves low medication adherence and is effective in addressing DRPs and concerns regarding chronic medicines use. Trial registration ClinicalTrials.gov - NCT04417400; 4th June 2020; retrospectively registered.

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