Good Clinical Practice Recommendations Research Articles

Management of intrathecal baclofen therapy for severe acquired brain injury: consensus and recommendations for good clinical practice.

Although widespread in the treatment of generalised spasticity due to severe acquired brain injury, clinical use of intrathecal baclofen administered through an implanted catheter is not yet supported by full scientific evidence. The aim of the study is to provide recommendations for good clinical practice regarding intrathecal baclofen therapy. We used a modified RAND Delphi method to develop consensus-based medical guidelines, involving clinicians who use intrathecal baclofen therapy throughout Italy. The clinicians were asked 38 questions grouped in six areas (patient selection, contraindications for implant, tests prior to implant, method of implant and management of therapy, efficacy evaluation and goal setting, and management of complications). To establish consensus, 75% agreement was required in answers to every question. Consensus was reached on the second round of the Delphi process on 27/38 questions (71%), specifically those regarding identification of objectives, efficacy evaluation, and method of implant and management of therapy, whereas management of complications and contraindications for implant remained critical areas. Despite the limits of our method, a set of recommendations was drawn up for clinical practice in this sector. The study also revealed residual critical areas and indicated future lines of research necessary to reach evidence-based consensus.

An update of the Italian Stroke Organization-Stroke Prevention Awareness Diffusion Group guidelines on carotid endarterectomy and stenting: A personalized medicine approach.

Although proof-based medicine has generated much valid evidence for the drawing up of guidelines and recommendations for best clinical practice in symptomatic and asymptomatic carotid stenosis, whether and when it is better to employ endarterectomy or stenting as the intervention of choice still remain matters of debate. Moreover, guidelines have been targeted up to now to the 'representative' patient, as resulting from the statistical analyses of the studies conducted on the safety and efficacy of both interventions as well as on medical therapy alone. The Italian Stroke Organization (ISO) and Stroke Prevention and Awareness Diffusion (SPREAD) group has thus decided to update its statements for an 8th edition. To this end, a multidisciplinary team of authors representing Italian scientific societies in the neurology, neuroradiology, vascular and endovascular surgery, interventional cardiology, and general medicine fields re-examined the literature available on stroke. Analyses and considerations on patient subgroups have allowed to model the risks/benefits of endarterectomy and stenting in the individual. Accordingly, the guideline's original methodology has been revised to follow the new SIGN (Scottish Intercollegiate Guideline Network) Grade-like approach, integrating it with new considerations on Precision, or Personalized Medicine. Therefore, this guideline offers recommendations on precision medicine for the single patient, and can be followed in addition to the more standard guidelines.

Characteristics and Practice in German Psychiatric Day-Clinics

In 2014 the growing number of psychiatric Day-Clinics was surveyed for standards in facilities, organisation and therapy details. By the huge number of Day-Clinics there should be given some evidence for best practice. With a self-made questionnaire all 676 Day-Clinics were extensively interviewed. The results were evaluated for frequency, mean value and correlations. Relevant data is now available for duration, organisation and intensity of treatment, room and personnel. Also some Day-Clinical specifics can be shown with effects on financial support. On the basis of the current good clinical practice recommendations for existing or new established Day-Clinics can be developed.

Enhancing Clinical Research Professionals' Training and Qualifications (ECRPTQ): Recommendations for Good Clinical Practice (GCP) training for investigators and study coordinators.

The translation of discoveries to drugs, devices, and behavioral interventions requires well-prepared study teams. Execution of clinical trials remains suboptimal due to varied quality in design, execution, analysis, and reporting. A critical impediment is inconsistent, or even absent, competency-based training for clinical trial personnel. In 2014, the National Center for Advancing Translational Science (NCATS) funded the project, Enhancing Clinical Research Professionals' Training and Qualifications (ECRPTQ), aimed at addressing this deficit. The goal was to ensure all personnel are competent to execute clinical trials. A phased structure was utilized. This paper focuses on training recommendations in Good Clinical Practice (GCP). Leveraging input from all Clinical and Translational Science Award hubs, the following was recommended to NCATS: all investigators and study coordinators executing a clinical trial should understand GCP principles and undergo training every 3 years, with the training method meeting the minimum criteria identified by the International Conference on Harmonisation GCP. We anticipate that industry sponsors will acknowledge such training, eliminating redundant training requests. We proposed metrics to be tracked that required further study. A separate task force was composed to define recommendations for metrics to be reported to NCATS.

Bioresorbable Vascular Scaffolds in Routine Clinical Practice

The practice of cardiovascular medicine is rapidly evolving, with an increasing number of new pharmaceutical agents and medical devices being evaluated for clinical safety and efficacy. Recommendations for good clinical practice are on the basis of the results derived from quality studies. Data from

Does the use of coercion improve the outcome of patients with severe mental disorders?

Coercive measures have always been part of the psychiatric armamentarium; however, the clinical and ethical dilemma between the use of a “therapeutic” coercion and the loss of patients’ dignity is one of the most controversial issues in mental health practice. According to International guidelines, coercive measures should be adopted only when all the other less restrictive approaches failed and should be considered as the “last restrictive alternative”. Although coercive measures are frequently used to manage patients’ aggressive behaviors and self-harm, refusal of medication and impulsivity, their effect on patients’ outcome is not clear. In fact, the use of coercive measures can reduce patients’ aggressiveness and improve psychiatric symptoms, but can also have a negative impact in terms of therapeutic relationship, engagement with mental health services and self-stigma, arising negative feelings on patients and on mental health professionals. International attempts have been made to improve and harmonize the use of involuntary treatments. Recommendations of good clinical practice on the use of coercive involountary treatments and forced medications have been proposed by the EUNOMIA consortium, and the effect of coercion on the outcome of patients with severe mental disorders have been described. Results of this study will be reported as well as lessons learnt from other international experiences.Disclosure of interestThe author has not supplied his declaration of competing interest.

Prescriptions of Proton-Pump Inhibitors Non-Compliant with Recommendations

Context: In 2013, reimbursements for Proton-Pump Inhibitors (PPIs) amounted to nearly 530 million euros in France. PPI usage was subject to official recommendations in France in 2007 and 2009. Six years later, however, they are being prescribed primarily for off-label uses. This study sought to further light the prevalence of noncompliant PPI prescriptions at our institution. Patients and methods: Transversal, descriptive, observational 1-day study including all patients receiving at least one PPI, in all conventional hospitalization and intensive care wards at a university hospital centre. The study excluded day- and week-stay hospitalization wards, the emergency department, as well as the short-term hospitalization and care ward. Besides demographic data, comorbidity was assessed based on the Charlson index. Medications that could potentially interact with PPIs were recorded. Results: In total, 26 wards participated and 519 patients were assessed, 198 of which (38%), aged 67 ± 13 years on average, were receiving a PPI treatment, were including 113 men (57%). The average Charlson score was 1.7 ± 2. Amongst these 198 patients, 50 (25%; IC95%: [19-32%]) were taking PPIs in compliance with official recommendations for best clinical practice, and 126 (63%) were additionally undergoing at least one treatment known to cause drug interactions with PPIs. For all included wards, expenditures for PPIs amounted to 31.57 Euros for the study day. Conclusion: Over one out of three hospitalized patients (38%) were receiving a PPI (23% had a PPI at arrival). Whilst over half of prescriptions exhibited potential drug interactions, only 25% of them complied with good clinical practice recommendations. The significant number of such prescriptions may be explained by their low cost, the image of good tolerance they enjoy, a lack of information regarding side-effects and drug interactions, fear of ceasing PPI administration with ensuing peptic ulcers, as well as unwillingness to question a prescription lacking proper scientific basis. Prescribers must, therefore, be better informed.

Evidence-based treatment of voice and speech disorders in Parkinson disease.

Voice and speech impairments are present in nearly 90% of people with Parkinson disease and negatively impact communication and quality of life. This review addresses the efficacy of Lee Silverman Voice Treatment (LSVT) LOUD to improve vocal loudness (as measured by vocal sound pressure level vocSPL) and functional communication in people with Parkinson disease. The underlying physiologic mechanisms of Parkinson disease associated with voice and speech changes and the strength of the current treatment evidence are discussed with recommendations for best clinical practice. Two randomized control trials demonstrated that participants who received LSVT LOUD were significantly better on the primary outcome variable of improved vocSPL posttreatment than alternative and no treatment groups. Treatment effects were maintained for up to 2 years. In addition, improvements have been demonstrated in associated outcome variables, including speech rate, monotone, voice quality, speech intelligibility, vocal fold adduction, swallowing, facial expression and neural activation. Advances in technology-supported treatment delivery are enhancing treatment accessibility. Data support the efficacy of LSVT LOUD to increase vocal loudness and functional communication in people with Parkinson disease. Timely intervention is essential for maximizing quality of life for people with Parkinson disease.

Intrathecal drug delivery for the management of pain and spasticity in adults: an executive summary of the British Pain Society's recommendations for best clinical practice.

This article provides a summary of the updated British Pain Society Guidance on Intrathecal Drug Delivery for the management of pain and spasticity in adults. We aim to highlight the areas of the guidance that have been updated and to provide a concise summary.

Resultados de la aplicabilidad de las «do not do recommendations» del National Institute for Health and Care Excellence en un hospital de alta complejidad

AimsTo qualitatively and quantitatively identify the level of agreement between the clinical staff of a quaternary care hospital and the National Institute for Health and Care Excellence (NICE) “do not do” recommendations, and to submit a strategic alternative for effective implementation. MethodAn ad hoc form was designed to evaluate level of clinical disagreement from the experience and knowledge of the clinical staff, as well as the applicability, usefulness, effectivity and efficiency of all the NICE “do not do” recommendations that had been published up to June 2012, checking their stability up to the July 2014 update. Description of the process of design and implementation of the strategic alternative to improve compliance is presented. ResultsThe great majority (90%) of Clinical Unit directors agree with the NICE recommendations, with 64% finding them useful or very useful, 52% finding them applicable, and 32% and 34% thinking they are of high effectivity and efficiency, respectively. However, 20% of the efficient ones are not being applied. Moreover, knowledge discordances that might lead to clinical disagreements were detected. A strategic intervention, combining culture and incentives for good clinical practices, has been implemented. ConclusionsThe improvement in the use of the good clinical practice recommendations is directly related to the agreement of its definition and evidence. An evaluation strategy of its application by the health professionals is essential to achieve an impact in avoidable costs. Moreover, to control for harmful effects of the economic impact on patient safety, it will be necessary to simultaneously evaluate clinical/health outcome indicators tightly linked to the applied recommendations.

Approach to the Treatment of Atrial Fibrillation in Patients with Cardiovascular Risk Profile: Multicentric International Study

Atrial fibrillation (AF), the most common arrhythmia that requires treatment, does not come out of the focus of researchers. Monitoring its prevalence and effects of therapy is a good guideline approach to the growing population of patients in which this arrhythmia occurs. The aim of the study was to evaluate the efficacy of treatment of AF and cardiovascular profiles in the observed population. In this observational, cross-sectional, multicenter, international study, 584 patients in 30 centers in Serbia and Slovenia, older than 18 years and with AF or in sinus rhythm with a history of AF, were included. The assessment of the efficacy of treatment of AF was performed by analyzing the frequency of adequate therapeutic effect of medication in rhythm or frequency control in patients with AF. The results confirmed that the highest incidence of AF duration is more than seven days, and is accompanied by symptoms. Inadequate frequency regulation was registered at 8.9% of patients. Hypertension was registered in two-thirds of all patients, while other cardiovascular risk factors were registered in about one-third of patients. An echocardiographic finding in the group of patients with AF confirms generally adequate left ventricular function with a slightly enlarged left atrium (4.6±0.8 cm). Increasing age and time from the first episode of AF decreases the probability of maintaining sinus rhythm, while symptomatic AF had a positive impact on the presence of sinus rhythm. Propafenone, sotalol and amiodarone showed a statistically significant connection with a positive therapeutic response, while 3-blockers had a negative impact on the probability of establishing and maintaining sinus rhythm. Characteristics of therapeutic approaches, risks, comorbidity of patient populations in Slovenia and Serbia correspond to the fullest extent with the recommendations for good clinical practice, which further stresses the need for extensive measures in these regions.

Good clinical practice recommendations on management of infertility in patients from India with polycystic ovary syndrome

Good clinical practice recommendations on management of infertility in patients from India with polycystic ovary syndrome

Sa1004 Measurement of Liver and Spleen Stiffness by ARFI Elastography: Intra-and Inter-Observer Variability and Predictors of Variability

Staging hepatocellular carcinoma (HCC) is an esential step in the decision regarding treatment options. Malignant portal vein thrombosis is a contraindication for all curative treatment, thus establishing the nature (benign or malignant) of PVT is mandatory for staging the disease. The AIM of this paper was to assess the role of contrast enhanced ultrasound (CEUS) for the staging of HCC in patients with liver cirrhosis. METHODS: We evaluated 86 consecutive patients with liver cirrhosis and known HCC, who were discovered with PVT located in different parts of the portal system. Before CEUS we performed a standard ultrasound and a Doppler examination. We used 2.4 ml of second generation contrast agent (SonoVue) for every examination. During the CEUS examination we followed the arterial, portal and late phases as defined in the EFSUMB Guidelines (1) and also the enhancement pattern as described by Rossi et al. (Type 1: thrombus enhancement is absent in all three phasesbenign thrombus; and for malign thrombus-Type 2: diffuse thrombus enhancement that is visible only during the early arterial phase; Type 3: linear or punctate enhancement; Type 4: multilinear or multipunctate enhancement)(2). RESULTS: PVT was located in the proximity of HCC in 63 of the 86 cases (73.2 %). 11 cases (12.7%) were Type 1 Rossi (benign thrombus), 44 cases (51.1%) were Type 2, 14 cases (16.2%) were Type 3 and 17 cases (19.7%) were Type 4 Rossi. Using CEUS we could characterise and obtain a conclusive diagnosis in 85 of the 86 patients (98.8%). CONCLUSIONS CEUS is a method with a good sensibility for the characterisation of PVT in patients with HCC, that allows the staging of the disease for a good therapeutic decision. BIBLIOGRAPHY: 1. M. Claudon, C. F. Dietrich, B. I. Choi, D. O. Cosgrove, M. Kudo, C. P. Nolsoe, F. Piscaglia, S. R. Wilson, R. G. Barr, M. C. Chammas, N. G. Chaubal, M.-H. Chen, D. A. Clevert, J. M. Correas, H. Ding, F. Forsberg, J. B. Fowlkes, R. N. Gibson, B. B. Goldberg, N. Lassau, E. L. S. Leen, R. F. Mattrey, F. Moriyasu, L. Solbiati, H.-P. Weskott, H.-X. Xu. Guidelines and Good Clinical Practice Recommendations for Contrast Enhanced Ultrasound (CEUS) in the Liver-Update 2012. Published online: 2012 Ultraschall in Med. 2. Rossi S. et al. Contrast-Enhanced Versus Conventional and Color Doppler Sonography for the Detection of Thrombosis of the Portal and Hepatic Venous Systems. AJR 2006; 186:763-773.

Sa1003 Diagnosis of Benign and Malignant Portal Vein Thrombosis in Cirrhotic Patients With Hepatocellular Carcinoma Using Contrast-Enhanced Ultrasound (CEUS)

Staging hepatocellular carcinoma (HCC) is an esential step in the decision regarding treatment options. Malignant portal vein thrombosis is a contraindication for all curative treatment, thus establishing the nature (benign or malignant) of PVT is mandatory for staging the disease. The AIM of this paper was to assess the role of contrast enhanced ultrasound (CEUS) for the staging of HCC in patients with liver cirrhosis. METHODS: We evaluated 86 consecutive patients with liver cirrhosis and known HCC, who were discovered with PVT located in different parts of the portal system. Before CEUS we performed a standard ultrasound and a Doppler examination. We used 2.4 ml of second generation contrast agent (SonoVue) for every examination. During the CEUS examination we followed the arterial, portal and late phases as defined in the EFSUMB Guidelines (1) and also the enhancement pattern as described by Rossi et al. (Type 1: thrombus enhancement is absent in all three phasesbenign thrombus; and for malign thrombus-Type 2: diffuse thrombus enhancement that is visible only during the early arterial phase; Type 3: linear or punctate enhancement; Type 4: multilinear or multipunctate enhancement)(2). RESULTS: PVT was located in the proximity of HCC in 63 of the 86 cases (73.2 %). 11 cases (12.7%) were Type 1 Rossi (benign thrombus), 44 cases (51.1%) were Type 2, 14 cases (16.2%) were Type 3 and 17 cases (19.7%) were Type 4 Rossi. Using CEUS we could characterise and obtain a conclusive diagnosis in 85 of the 86 patients (98.8%). CONCLUSIONS CEUS is a method with a good sensibility for the characterisation of PVT in patients with HCC, that allows the staging of the disease for a good therapeutic decision. BIBLIOGRAPHY: 1. M. Claudon, C. F. Dietrich, B. I. Choi, D. O. Cosgrove, M. Kudo, C. P. Nolsoe, F. Piscaglia, S. R. Wilson, R. G. Barr, M. C. Chammas, N. G. Chaubal, M.-H. Chen, D. A. Clevert, J. M. Correas, H. Ding, F. Forsberg, J. B. Fowlkes, R. N. Gibson, B. B. Goldberg, N. Lassau, E. L. S. Leen, R. F. Mattrey, F. Moriyasu, L. Solbiati, H.-P. Weskott, H.-X. Xu. Guidelines and Good Clinical Practice Recommendations for Contrast Enhanced Ultrasound (CEUS) in the Liver-Update 2012. Published online: 2012 Ultraschall in Med. 2. Rossi S. et al. Contrast-Enhanced Versus Conventional and Color Doppler Sonography for the Detection of Thrombosis of the Portal and Hepatic Venous Systems. AJR 2006; 186:763-773.

Management of hepatocellular carcinoma: The role of contrast-enhanced ultrasound

Hepatocellular carcinoma (HCC) is the sixth most common neoplasm and the third cause of cancer death worldwide. Contrast enhanced ultrasound (CEUS) has been applied for more than ten years and plays increasingly important roles in the management of HCC. On the basis of the Guideline and Good Clinical Practice Recommendations for CEUS in the liver-update 2012 and related literature about the management of HCC, we summarize the main roles and applications of CEUS in the management of HCC, including HCC surveillance, diagnosis, CEUS-guided treatment, treatment response evaluation and follow-up. The diagnostic algorithm for HCC is also suggested. Meanwhile, the comparisons between CEUS and contrast enhanced computed tomography/magnetic resonance imaging (CECT/CEMRI) in these areas are made. Although CEUS is subject to the same limitation as ordinary US and is inferior to CECT/CEMRI in some aspects, CEUS has proved to be of great value in the management of HCC with inherent advantages, such as sufficient high safety profile making it suitable for patients with renal failure or allergic to iodine, absence of radiation, easy reproducibility and high temporal resolution. The tremendous application of CEUS to the diagnosis and treatment of HCC provides more opportunities for patients with HCC diagnosed at different stages.

Trialogue Plus

Diabetes mellitus and hyperglycaemia are both independent risk factors (RF) for cardiovascular (CV) events and increased general and CV mortality. Type 2 diabetes, which is often associated with obesity, hypertension and dyslipidaemia, is accompanied by an up to fourfold increase in the incidence of acute coronary heart disease compared to normoglycaemia, even when other CV RF are equal. In the diabetic population, acute CV events are more likely to have associated cardiac complications, such as heart failure, and CV mortality is increased by twofold–fourfold. Several patients, hospitalised in medical, cardiology and intensive care departments, have undiagnosed diabetes mellitus or elevated glucose levels at the time of admission. These conditions require intensive care in the acute phase and dedicated follow-up at discharge. The Trialogue Plus project was created with the goal of providing good clinical practice guidelines and recommendations for the management of CV risk in patients with diabetes/hyperglycaemia at discharge from hospital. The aim is developing a document that defines timing, diagnostics, targets and therapeutic strategy for the management of CV risk, both in primary and in secondary prevention of patients with diabetes/hyperglycaemia who have experienced an event, involving the Diabetologist, Cardiologist, Internist, GP and area Specialists. This document concerns the implementation of existing guidelines and consensus statements, and as such, the recommendations have not been classified on the basis of scientific evidence and strength.

Trialogue

Hyperglycaemic patients admitted to hospital have worse clinical outcomes with higher operational costs than normoglycaemic patients. Identifying, defining and treating hyperglycaemia promptly and appropriately is essential during hospitalisation; adequate 'continuity of care' must be assured after discharge. This requires a multidisciplinary clinical collaboration between the internist and the diabetes team, which plays a central role in the treatment course and should be involved soon after patient admission to the hospital. This document aims to establish guidelines and recommendations for good clinical practice in managing hyperglycaemic internal medicine patients, with or without previous diagnosis of diabetes. The Associazione Medici Diabetologi (AMD), Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) and Società Italiana di Diabetologia (SID) have decided to publish a document useful for internists in the management of hospitalised patients with hyperglycaemia. The Trialogue project, coordinated by a Board of Scientific Experts from the three scientific societies, was initiated for this purpose. A questionnaire consisting of 16 multiple choice questions on the management of hyperglycaemia in hospital was answered by 660 physicians from over 250 Internal Medicine units distributed throughout Italy. Analysis of responses has yielded an overview of routine clinical practice and provided a wealth of ideas to better identify critical points in the treatment of hospitalised patients with hyperglycaemia. These recommendations were developed with the aim of providing mutually agreed practical guidance (instructions for use) that can be readily applied by healthcare professionals in routine clinical practice.

Spinal cord stimulation for the management of pain: Recommendations for best clinical practice

Spinal cord stimulation (SCS) is an accepted method of pain control. SCS has been used for many years and is supported by a substantial evidence base. A multidisciplinary consensus group has been convened to create a guideline for the implementation and execution of an SCS programme for South Africa (SA). This article discusses the evidence and appropriate context of SCS delivery, and makes recommendations for patient selection and appropriate use. The consensus group has also described the possible complications following SCS. This guideline includes a literature review and a summary of controlled clinical trials of SCS. The group notes that, in SA, SCS is performed mainly for painful neuropathies, failed back surgery, and chronic regional pain syndrome. It was noted that SCS is used to treat other conditions such as angina pectoris and ischaemic conditions, which have therefore been included in this guideline. These recommendations give guidance to practitioners delivering this treatment, to those who may wish to refer patients for SCS, and to those who care for patients with stimulators in situ. The recommendations also provide a resource for organisations that fund SCS. This guideline has drawn on the guidelines recently published by the British Pain Society, and parts of which have been reproduced with the society's permission. These recommendations have been produced by a consensus group of relevant healthcare professionals. Opinion from outside the consensus group has been incorporated through consultation with representatives of all groups for whom these recommendations have relevance. The recommendations refer to the current body of evidence relating to SCS. The consensus group wishes to acknowledge and thank the task team of the British Pain Society for their help and input into this document.

Trialogue. Managing hyperglycaemia in internal medicine. Instructions for use: Consensus document of the Associazione Medici Diabetologi (AMD), Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) and Società Italiana di Diabetologi

Hyperglycaemic patients admitted to hospital have worse clinical outcomes with higher operational costs than normoglycaemic patients. Identifying, defining and treating hyperglycaemia promptly and appropriately is essential during hospitalization; adequate “continuity of care” must be assured after discharge. This requires a multidisciplinary clinical collaboration between the internist and the diabetes team, which plays a central role in the treatment course and should be involved soon after patient admission to the hospital. This document aims to establish guidelines and recommendations for good clinical practice in managing hyperglycaemic Internal Medicine patients, with or without previous diagnosis of diabetes. The Associazione Medici Diabetologi (AMD), Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) and Società Italiana di Diabetologia (SID) have decided to publish a document useful for internists in the management of hospitalised patients with hyperglycaemia. The Trialogue project, coordinated by the Board of Scientific experts from the three Scientific Societies, was initiated for this purpose. A questionnaire consisting of 16 multiple choice questions on the management of hyperglycaemia in hospital was answered by 660 physicians from over 250 internal medicine units distributed throughout Italy. Analysis of responses has yielded an overview of routine clinical practice and provided a wealth of ideas to better identify critical points in the treatment of hospitalized patients with hyperglycaemia. These recommendations were developed with the aim of providing mutually agreed practical guidance (instructions for use) that can be readily applied by healthcare professionals in routine clinical practice.

Professional standards to review medication orders. Recommendations for Good Clinical Pharmacy Practice in France

Professional standards to review medication orders. Recommendations for Good Clinical Pharmacy Practice in France