Diretrizes Metodológicas : Avaliação de Desempenho de Tecnologias em Saúde

In recent years, significant advances have been registered in the health area with the discovery of new technologies. These advances have been accompanied by a rise in treatment costs and have put health spending among the largest expenditures of public and family systems around the world. Despite the undeniable scientific advances, many health technologies launched in the international market do not have the expected benefits and, in some situations, still introduce iatrogenies. In order to respond to the need to measure, evaluate and select the products, equipment, medicines and health procedures that merit use in health systems, scientific methods have been developed to assist the process of incorporating health technologies. A set of standardized analyzes of effectiveness, safety, effectiveness, efficiency and costs has contributed in a relevant way to the processes that incorporate new technologies. However, post-incorporation studies published in the international literature that present disturbing results are not rare in that many of these technologies, when used in real life, do not actually have the benefits reported by manufacturers. For this reason, many challenges still permeate the little explored process of evaluating the performance of the technologies available and the consequent need to establish a process of divestment and reinvestment in health

A qualitative study on factors influencing the implementation of a Clostridium difficile risk prediction tool in the Scottish secondary care setting

Introduction: Clostridium difficile is the leading cause of hospital acquired diarrhoea, driven by the consumption of 4C antibiotics (co-amoxiclav, clindamycin etc..). In order to support clinicians with the prescription of antibiotic in secondary care, an algorithm to help identify high risk patients to contract Clostridium difficile infection (CDI) has been created. The aim of this study is to identify factors that are influencing the development and implementation of a risk predictive tool for CDI in secondary care. Methods: Four Scottish Podiatrist from Fife were interviewed to gather their perception on CDI, their antibiotic prescription process and whether a CDI tool would support their prescription process. The interviews were inductively analysed in NVivo using the consolidated framework for implementation research to identify factors influencing the development and implementation of the CDI tool. Result: The preliminary interview themes suggests that although Podiatrist in secondary care don’t perceive many cases of CDI, they would like to have risk predictor for CDI for patient’s safety netting purposes. As there isn’t a concrete and accurate electronic health record in secondary care, the CDI tool can’t be implemented into their system, therefore a standalone app or website has to be developed. Conclusion: The next stage is to collaborate with a company to develop a prototype of the CDI tool and test it with secondary care clinicians using case scenarios

Protocol for the effective feedback to improve primary care prescribing safety (EFIPPS) study : a cluster randomised controlled trial using ePrescribing data

High-risk prescribing in primary care is common and causes considerable harm. Feedback interventions to improve care are attractive because they are relatively cheap to widely implement. There is good evidence that feedback has small to moderate effects, but the most recent Cochrane review called for more high-quality, large trials that explicitly test different forms of feedback. The study is a three-arm cluster-randomised trial with general practices being randomised and outcomes measured at patient level. 262 practices in three Scottish Health Board areas have been randomised (94% of all possible practices). The two active arms receive different forms of prescribing safety data feedback, with rates of high-risk prescribing compared with a ‘usual care’ arm. Sample size estimation used baseline data from participating practices. With 85 practices randomised to each arm, then there is 93% power to detect a 25% difference in the percentage of high-risk prescribing (from 6.1% to 4.5%) between the usual care arm and each intervention arm. The primary outcome is a composite of six high-risk prescribing measures (antipsychotic prescribing to people aged ≥75 years; non-steroidal anti-inflammatory drug (NSAID) prescribing to people aged ≥75 without gastroprotection; NSAID prescribing to people prescribed aspirin/clopidogrel without gastroprotection; NSAID prescribing to people prescribed an ACE inhibitor/angiotensin receptor blocker and a diuretic; NSAID prescription to people prescribed an oral anticoagulant without gastroprotection; aspirin/clopidogrel prescription to people prescribed an oral anticoagulant without gastroprotection). The primary analysis will use multilevel modelling to account for repeated measurement of outcomes in patients clustered within practices. The study was reviewed and approved by the NHS Tayside Committee on Medical Research Ethics B (11/ES/0001). The study will be disseminated via a final report to the funder with a publicly available research summary, and peer reviewed publications

Use of direct oral anticoagulants in patients with atrial fibrillation in Scotland : applying a coherent framework to drug utilisation studies

Purpose: To report the use of direct oral anticoagulants (DOAC) for stroke prevention in patients with atrial fibrillation (AF) in Scotland and advocate the standardisation of drug utilisation research methods. Methods: Retrospective cohort study using linked administrative data. Patients included those with a diagnosis of AF (confirmed in hospital) who received a first prescription for a DOAC (dabigatran, rivaroxaban, apixaban) from September 2011 to June 2014. Drug utilisation measures included discontinuation, persistence, and adherence. Results: 5398 patients (mean CHA2DS2-VASc score 2.98 [SD 1.71], 89.7% with ≥ 6 concomitant medicines) were treated with DOACs for a median of 228 days (IQR 105 – 425). Of 35.6% who discontinued DOAC treatment, 11.0% switched to warfarin and 48.3% re-initiated DOACs. Persistence after 12 and 18 months were 75.9% and 69.8%, respectively. Differences between individual DOACs were observed: discontinuation rates ranged from 20.4% (apixaban) to 60.6% (dabigatran), and 12 months persistence from 60.1% (dabigatran) to 85.5% (apixaban). Adherence to treatment with all DOACs was good: overall DOAC median medication refill adherence (MRA) was 102.9% (IQR 88.9% – 115.5%), and 82.3% of patients had an MRA > 80%. Conclusions: In Scotland, adherence to DOAC treatment was good and switching from DOAC to warfarin was low. However, discontinuation and persistence rates were variable – although treatment interruptions were often temporary. To decrease the inconsistencies in drug utilisation methods and facilitate meaningful study comparison, the use of a coherent framework – using a combination of discontinuation, persistence and adherence – and the standardisation of measurements is advocated

Bayesian hierarchical approaches for multiple outcomes in routinely collected healthcare data

Background: Routinely collected healthcare data provides a rich environment for the investigation of drug performance in the general population, while also offering the possibility of assessing rare outcomes. The statistical analysis of this data poses a number of challenges. The data may be biased and lack the structure and balance provided by the drugs’ clinical trials. Outcomes are often modelled individually with an associated lack of control for multiple comparisons, as well as a difficulty in assessing multiple risks. Methods: Bayesian models provide methods for analysing multiple clinical outcomes, using relationships between outcomes and handling the types of multiple comparison issues which may occur when using multiple single-variate approaches. Lack of balance within the data may be catered for by dividing the population into clusters with similar characteristics, allowing within cluster inferences to be made. A Bayesian hierarchical model for multiple outcomes is proposed and applied to data from a safety and effectiveness study of direct oral anticoagulants (DOACs) in Scotland 2009 – 2015. Results: The Bayesian modelling results were comparable to the results from the original safety and effectiveness study, with the additional benefit of balancing patient clusters and controlling for relationships in the data. Conclusion: Bayesian hierarchical models are a suitable approach for modelling routinely collected healthcare data. There is the possibility of moving to an integrated Bayesian approach, with the inclusion of treatment relationships; uncertainty regarding cluster membership; and treatment allocation in the model, eventually leading to more reliable treatment decisions

Macmillan Pharmacy Service Project 2014 : Early Evaluation of Initial Community Pharmacy Palliative Care Training Programme

NHS Greater Glasgow & Clyde (GG&C) and Macmillan Cancer Support funded in 2013 the roll out of a new Macmillan Pharmacy Service following a successful development program across all six Community Health (and Care) Partnerships (CH(C)Ps). The University of Strathclyde was asked to support the early evaluation of an evolving training program for community pharmacy support staff within this new service. This report presents the evaluation of the training programme initial testing in NHS GG&C and the development of a questionnaire-based tool to measure the impact of the training delivered on practitioners and the patients/carers they support

Data resource profile : the Scottish national prescribing information system (PIS)

Data Resource Basics: The Prescribing Information System (PIS) covers the prescribed,dispensed and reimbursed prescriptions in community pharmacies from the 5.3 million residents in Scotland. Summary information is available from 1993 and at an individual level from 2009 to the present. Data Collected: The raw data are generated by three data sources: ePrescribed -generated by GPs messages, eDispensed –generated by messages from community pharmacies and Reimbursed messages from scanned paper prescriptions dispensed in the community pharmacies. The four main categories of data collected are: (1) Patient-specific, (2) Prescriber, (3) Dispenser and (4) Drug-specific. PIS data can be linked via a unique identifier to other national databases, including hospital records, maternal and neonatal, the Scottish Cancer Registry and mortality records. The catalogue of databases is available in www.ndc.scot.nhs.uk . Subject to approval of the data controllers other external datasets can also be linked. Data Resource Use: PIS has been used to describe the utilisation of several groups of drugs;factors influencing prescribing and evaluation of interventions to improve it; generation of polypharmacy guidelines; risk of side effects; monitoring of antibiotic use and generation of policy recommendations; associations between community prescription of antimicrobials and deprivation or infection; evaluation of prescription fee abolition; clinical effectiveness, safety and health technology assessment of drugs approved in the last decade. Reasons to be cautious: PIS does not capture information about diagnosis or indication for treatment, over the counter medicines, medicines administered during inpatient hospital stays, upon discharge for short term use, outpatient supplies or some specialist drugs for chronic use. Drug data is currently coded according to the British National Formulary. For longitudinal studies, patient level data is available from 2009 and the frequency of data collection from the three sources is different. Collaboration and data access: PIS data are available upon request to the electronic Data Research and Innovation Service ([email protected]) and project approval by the Public Benefit and Privacy Panel. Funding and competing interests: This dataset is funded from the public monies available to the NHS. Current work to develop an improved PIS research ready analysis platform and this study is supported by the Farr Institute @ Scotland and its 10-funder consortium. The authors declare no conflict of interest

Comparative safety and effectiveness of direct oral anticoagulants in patients with atrial fibrillation in clinical practice in Scotland

To compare the clinical effectiveness and safety of direct oral anticoagulants (DOACs) in patients with atrial fibrillation (AF) in routine clinical practice. Retrospective cohort study using linked administrative data. The study population (n=14,577) included patients with a diagnosis of AF (confirmed in hospital) who initiated DOAC treatment in Scotland between August 2011 and December 2015. Multivariate Cox proportional hazard models were used to estimate hazard ratios of thromboembolic events, mortality, and bleeding events. No differences between the DOACs were observed in the risks of stroke, systemic embolism, or cardiovascular death. In contrast, the risk of myocardial infarction was higher among apixaban patients in comparison to rivaroxaban (1.67 [1.02 - 2.71]), and all-cause mortality was higher among rivaroxaban patients in contrast to both apixaban (1.22 [1.01 - 1.47]) and dabigatran (1.55 [1.16 - 2.05]); rivaroxaban patients also had a higher risk of pulmonary embolism than apixaban patients (5.27 [1.79 - 15.53]). The risk of other major bleeds was higher among rivaroxaban patients compared to apixaban (1.50 [1.10 - 2.03]) and dabigatran (1.58 [1.01 - 2.48]); the risks of gastro-intestinal bleeds and overall bleeding were higher among rivaroxaban patients than among apixaban patients (1.48 [1.01 - 2.16] and 1.52[1.21 - 1.92], respectively). All DOACs were similarly effective in preventing strokes and systemic embolisms, while patients being treated with rivaroxaban exhibited the highest bleeding risks. Observed differences in the risks of all-cause mortality, myocardial infarction, and pulmonary embolism warrant further research. [Abstract copyright: This article is protected by copyright. All rights reserved.

Review of ongoing initiatives to improve prescribing efficiency in China; angiotensin receptor blockers as a case history

Pharmaceutical expenditure is rising by 16% per annum in China and is now 46% of total expenditure. Initiatives to moderate growth include drug pricing regulations and encouraging international non-proprietary name prescribing. However, there is no monitoring of physician prescribing quality and perverse incentives. Assess changes in angiotensin receptor blocker (ARB) utilization and expenditure as more generics become available; compare findings to Europe. Observational retrospective study of ARB utilization and expenditure between 2006 and 2012 in the largest hospital in Chongqing district. Variable and low use of generics versus originators with a maximum of 31% among single ARBs. Similar for fixed dose combinations. Prices typically reduced over time, greatest for generic telmisartan (-54%), mirroring price reductions in some European countries. However, no preferential increase in prescribing of lower cost generics. Accumulated savings of 33 million CNY for this large provider if they adopted European practices. Considerable opportunities to improve prescribing efficiency in China