Good Clinical Practice Recommendations Research Articles

Effectiveness of an adaptive, multifaceted intervention to enhance care for patients with complex multimorbidity in general practice: protocol for a pragmatic cluster randomised controlled trial (the MM600 trial)

IntroductionPatients with complex multimorbidity face a high treatment burden and frequently have low quality of life. General practice is the key organisational setting in terms of offering people with complex...

Recommendations for good clinical practice for DPD bone scintigraphy for cardiac amyloidosis.

Recommendations for good clinical practice for DPD bone scintigraphy for cardiac amyloidosis.

Primary central nervous system marginal zone lymphoma.

Marginal zone lymphoma (MZL) is the most common indolent lymphoma primarily arising in the central nervous system (CNS). To date, 207 cases of primary CNS MZL (PCNSMZL) were published, mostly as single case reports or small case series. It most commonly presents as extra-axial dural-based masses, more frequently in middle-aged women, displaying an insidious onset, with a long history of symptoms preceding the diagnosis. PCNSMZL can be radiographically mistaken for meningioma. PCNSMZL consists of CD20+ , CD3- small B lymphocytes with varying degrees of plasmacytic differentiation and low proliferation index. Trisomy 3, but not MALT1 or IgH translocation, is a common genetic abnormality. Other recurrent genetic abnormalities involve TNFAIP3 and NOTCH2. Ethiopathogenesis was poorly investigated. Due to its rarity, standard of care remains to be defined; it exhibits an excellent prognosis after varied treatments, such as surgery, radiotherapy, chemotherapy or their combinations. Nevertheless, each treatment should be considered after an accurate analysis of overtreatment risk. Short follow-up is a major limitation in reported PCNSMZL cases, which restrains our knowledge on long-term results and iatrogenic sequels. This review was focussed on presentation, differential diagnoses, pathological findings, treatment options and clinical outcomes of PCNSMZL; recommendations for best clinical practice are provided.

A Critical Interpretation of Ethics in Research

The moral standards that direct a person's behavior are known as ethics. Doing what is morally and legally correct in research is sometimes referred to as practicing research ethics. They are standards of behavior that set boundaries between what is morally correct and inappropriate. The article discusses the value of ethics in relation to organizing, carrying out, and disseminating research. Good Clinical Practice and several recommendations have been explored. The legal concerns that are pertinent to research procedures have been discussed in the essay. Researchers, ethics committees, and journal editors are just a few of the stakeholders who are very concerned about research misconduct and its consequences. The importance of research ethical awareness has been emphasized. Methodology: The material of research ethics has been collected from different, articles, authentic literatures, manuscripts, and authentic net sources, like NCBI, PubMed etc. Conclusion: For the researchers, a diligent mindset is crucial. To safeguard research participants from damage, it is crucial to uphold protocol compliance, informed consent processes, openness and integrity, confidentiality, and other standards.

The parent, child and young person experience of difficult venous access and recommendations for clinical practice: A qualitative descriptive study.

Explore the parent and child/young person experience of difficult venous access and identify ideas and preferences for changes to clinical practice. Peripheral intravenous catheter insertion is one of the most common invasive procedures in hospitalised paediatric patients. Multiple insertion attempts in paediatric patients are common and associated with pain and distress. Little research has explored the parent and child/young person experience of difficult venous access nor sought to identify their suggestions to improve clinical practice. Qualitative description. A purposive sampling approach was used to identify children and young people with experience of difficult venous access and their parents. Semi-structured interviews were conducted, with sample size based on data saturation. Transcripts were analysed using thematic analysis. There were 12 participants, seven parents and five children/young people (five parent/child dyads and two individual parents). Analysis of the data revealed three main themes: (1) Distress-before, during and after (2) Families navigating the system: the challenging journey from general clinician to specialist and (3) Difficult venous access impacts both treatment and life outside the hospital A pre-determined theme, (4) Recommendations for good clinical practice is also described. Multiple attempts to insert a peripheral intravenous catheter are a source of substantial distress for children/young people, leading to treatment avoidance. Effective interpersonal skills, providing choice and avoiding frightening language are important to minimise distress. Clinicians without specialist training should assess each child's venous access experience and consider immediate referral to a specialist if they have a history of difficult venous access. Cultural change is required so clinicians and healthcare services recognise that repeated cannulation may be a source of psychological distress for children/young people.

ISP good clinical practice recommendations for gum care.

Oral health is vital for the general well-being, overall body health and the quality of life throughout our lifetime. Most of the oral diseases and conditions are largely related to the maintenance of oral hygiene, lacking that people suffer from diverse oral diseases at different times in their life. With greater life expectancy, the individuals have teeth involved with periodontal diseases that would not only require professional care but also home gum care for them to last a lifetime. Indian Society of Periodontology (ISP) has recognized the need for systematic documents to update everyday clinical practice of general dental practitioners and have provided evidence-based consensus documents, namely good clinical practice recommendations from time to time to raise the oral health-related awareness and standards of oral healthcare delivery across the country. The current set of clinical practice recommendations focused to "Gum Care for All", is aimed at emphasizing and enhancing the awareness regarding oral health promotion, maintenance, and disease prevention. Twenty-five subject matter experts from across the nation, prepared these recommendations after a thorough literature review and group discussions. The document has been prepared in three distinct sections, namely pretherapeutic, therapeutic, and post therapeutic, to provide guidance during the respective phases of patient management and may serve as a quick and concise reference to the readers. The guidelines shall provide the distinct definitions, signs and symptoms, treatment required; recall visit specifications for plausible clinical case situations, home care advice regarding maintenance of oral hygiene including information on brushing technique, care and change of brush, use of interdental aids, and mouthwashes, etc. The document should advocate and guide the combined efforts of general dentists, and the population at large toward an empowered, evidence based, integrated, and comprehensive oral health care, which shall enhance the healthful functioning and longevity of the dentition and general health of the individual.

ESHRE certification of ART centres for good laboratory and clinical practice.

ESHRE certification of ART centres for good laboratory and clinical practice.

Monitoring Breast Cancer Care Quality at National and Local Level Using the French National Cancer Cohort

PurposeThe French National Cancer Institute has developed, in partnership with the French National Authority for Health, breast cancer-specific Care Quality, and Safety Indicators (BC QIs). With regard to the most common form of cancer, our aim is to support local and national quality initiatives, to improve BC pathways and outcomes, reduce heterogeneity of practice and regional inequities. In this study, we measure the BC QIs available in the French National medico-administrative cancer database, the French Cancer Cohort, for 2018. Materials and MethodsBC QIs are developed according to the RAND method. QIs are based on good clinical practice and care pathway recommendations. QI computation should be automatable without any additional workload for data collection. They will be published annually for all stakeholders, and especially hospitals. ResultsFinally, ten feasible and pertinent QIs were selected. In France, BC care was found to be close to compliance with most QIs: proportion of patients undergoing biopsy prior to first treatment (94.5%), proportion of patients undergoing adjuvant radiotherapy after breast-conserving surgery for BC (94.5%), proportion of women undergoing radiotherapy within 12 weeks after surgery and without chemotherapy (86.2%), proportion of DCIS patients undergoing immediate breast reconstruction (54.3%) and proportion of women with NMIBC undergoing breast reintervention (14.4%). However, some are still far from their recommended rate. In particular, some QIs vary considerably from one region, or one patient, to another. ConclusionEach result needs to be analyzed locally to find care quality leverage. This will strengthen transparency actions aimed at the public.

Enhanced feedback interventions to promote evidence-based blood transfusion guidance and reduce unnecessary use of blood components: the AFFINITIE research programme including two cluster factorial RCTs

Enhanced feedback interventions to promote evidence-based blood transfusion guidance and reduce unnecessary use of blood components: the AFFINITIE research programme including two cluster factorial RCTs

Risk of Unmasking on Schizophrenia Double Blind Clinical Trials Using Risperidone versus Comparator As A Result of Laboratory Analysis

Background: Randomized double blind clinical trial is the most used and accepted method of clinical research involving human subjects. Clinical researches are performed under strict regulatory regulations including Helsinki Declaration and International Conference for Harmonization Good Clinical Practice (ICH – GCP) recommendations. As per ICH GCP principles safety and well being of clinical trials patients should prevail over research objectives and their health status should be monitored throughout the trial using objective and concise indicators such as but not limited to laboratory analysis. This study aims to identify factors that might unblind risperidone treatment arms for patients enrolled in randomized double blind schizophrenia clinical trials using risperidone versus comparator, as a result of reviewing safety laboratory analysis. Methods: This study included 134 controlled schizophrenia patients who received treatment with risperidone versus antipsychotic agents with lower dopamine antagonist potency. Prolactine values were determined using imunoenzimatic and colorimetric method (ELISA) for cantitative determination of prolactine from serum or plasma. Results: 84% percent of the patients treated with risperidone showed elevated levels for prolactine above laboratory reference ranges defined as: Men ( 1.8 – 17.0 ng/ml) ; Women ( fertile 1.2 – 19.5 ng/ml, menopause 1.5 – 18.5 ng/ml) Conclusions: High elevated values of prolactin were determined for risperidone treated patients which might disclose the patient treatment arm to blinded investigator and jeopardize the research. As lab results are an essential safety factor of clinical trial those cannot be overruled and establishing Independent Data Monitoring Committee to oversee patients’ data and warn the investigator is recommended.

Which imaging in patients with low back pain ?

Low back pain is a major public health problem, with a significant physical and psychosocial impact. Inappropriate use of diagnostic imaging is one of the main factors contributing to the costs of these conditions. In addition, there is evidence to suggest that imaging and the accompanying report are risk factors for chronicity. This article reviews the main clinical situations that clinicians face and summarizes the good clinical practice recommendations for each of them.

ISP Good Clinical Practice Recommendations for the management of Dentin Hypersensitivity.

Dentin hypersensitivity (DH) is a rising concern in clinical dentistry that causes pain and discomfort and negatively affects the quality of life of patients. Indian Society of Periodontology conducted a nationwide survey, involving 3000 dentists in December 2020, which revealed significant knowledge gaps regarding DH, viz., under-diagnosis, incorrect differential diagnosis, and treatment strategies/recommendations for the management of DH patients in daily clinical practice. The current paper has been envisioned and conceptualized to update the practicing Indian dentists regarding the so-called enigma of dentistry “Dentin Hypersensitivity,” based on the best available contemporary evidence. An expert panel was constituted comprising 30 subject experts from across the country, which after extensive literature review and group discussions formulated these recommendations. The panel advocated routine screening of all dentate patients for exposed dentin areas and DH to avoid under-diagnosis of the condition and suggested an early preventive management. Consensus guidelines/recommendations for the use of desensitizing agents (DAs) at home, including the use of herbal agents, are also provided within the backdrop of the Indian context. The guidelines recommend that active management of DH shall be accomplished by a combination of at home and in-office therapies, starting with the simplest and cost-effective home use of desensitizing toothpastes. A diagnostic decision tree and a flowchart for application in daily practice are designed to manage the patients suffering from DH or presenting with exposed dentin areas in dentition. Various treatment methods to manage DH have been discussed in the paper, including the insights from previously published treatment guidelines. Further, a novel system of classification of DH patients based on specific case definitions has been developed for the first time. Explicit charts regarding the available treatment options and the chronology of institution of the agent, for the management in different case categories of DH, have been provided for quick reference. The management strategy takes into account a decision algorithm based on hierarchy of complexity of treatment options and intends to improve the quality of life of the patient by long-term maintenance with an innovatively defined triple C's or 3Cs approach.

Improving outcomes and quality of life for patients with transfusion-dependent β-thalassemia: recommendations for best clinical practice and the use of novel treatment strategies

ABSTRACT Introduction β-thalassemia is one of the most common inherited monogenic diseases. Many patients are dependent on a lifetime of red blood cell (RBC) transfusions and iron chelation therapy. Although treatments have a significant impact on quality of life (QoL), life expectancy, and long-term health outcomes have improved in recent decades through safer RBC transfusion practices and better iron chelation strategies. Advances in the understanding of the pathology of β-thalassemia have led to the development of new treatment options that have the potential to reduce the RBC transfusion burden in patients with transfusion-dependent (TD) β-thalassemia and improve QoL. Areas covered This review provides an overview of currently available treatments for patients with TD β-thalassemia, highlighting QoL issues, and providing an update on current clinical experience plus important practical points for two new treatments available for TD β-thalassemia: betibeglogene autotemcel (beti-cel) gene therapy and the erythroid maturation agent luspatercept, an activin ligand trap. Expert opinion Approved therapies, including curative gene therapies and supportive treatments such as luspatercept, have the potential to reduce RBC transfusion burden, and improve clinical outcomes and QoL in patients with TD β-thalassemia. Cost of treatment is, however, likely to be a significant barrier for payors and patients.

Management of cluster headache and other trigeminal autonomic cephalalgias in pregnancy and breastfeeding.

Many clinicians lack experience in managing trigeminal autonomic cephalalgias (TACs) in pregnancy and lactation. In addition to cluster headache, TACs include hemicrania continua, paroxysmal hemicrania, and short-lasting unilateral neuralgiform headache with conjunctival injection and tearing/autonomic symptoms (SUNCT/SUNA). Treating these rare, severe headache conditions often requires off-label drugs that have uncertain teratogenic potential. In the last few years, several new treatment options and safety documentation have emerged, but clinical guidelines are lacking. This narrative review aimed to provide an updated clinical guide and good clinical practice recommendations for the management of these debilitating headache disorders in pregnancy and lactation.

Breast cancer: initial workup and staging with FDG PET/CT.

PurposePrecise staging is needed to plan optimal management in breast cancer. 18F-fluorodeoxyglucose positron emission tomography coupled with computed tomography (FDG-PET/CT) offers high sensitivity in detecting extra axillary lymph nodes and distant metastases. This review aims to clarify in which groups of patients staging with FDG-PET/CT would be beneficial and should be offered. We also discuss how tumor biology and breast cancer subtypes should be taken into account when interpreting FDG-PET/CT scans.MethodsWe performed a comprehensive literature review and rigorous appraisal of research studies assessing indications for FDG-PET/CT in breast cancer. This assessment regarding breast cancer served as a basis for the recommendations set by a working group of the French Society of Nuclear Medicine, in collaboration with oncological societies, for developing good clinical practice recommendations on the use of FDG-PET/CT in oncology.ResultsFDG-PET/CT is useful for initial staging of breast cancer, independently of tumor phenotype (triple negative, luminal or HER2 +) and regardless of tumor grade. Considering histological subtype, FDG-PET/CT performs better for staging invasive ductal carcinoma, although it is also helpful for staging invasive lobular carcinomas. Based on the available data, FDG-PET/CT becomes useful for staging starting from clinical stage IIB. FDG-PET/CT is possibly useful in patients with clinical stage IIA (T1N1 or T2N0), but there is not enough strong data to recommend routine use in this subgroup. For clinical stage I (T1N0) patients, staging with FDG-PET/CT offers no added value.ConclusionFDG-PET/CT is useful for staging patients with breast cancer, starting from clinical stage IIB.

Improved Method of Contrast-enhanced Ultrasound examination of the Kidneys in Patients with Type 2 Diabetes Mellitus

Aim of the research. Тo evaluate the diagnostic efficacy of the contrast-enhanced ultrasound examination of kidneys in patients with type 2 diabetes mellitus with a dose of 0.5 ml of contrast agent administered.Materials and methods. We examined 12 patients with a verified diagnosis of type 2 diabetes. The age of the examined patients was 31–59 years, the mean age was 49 ± 1.3 years. All patients underwent complex diagnostics, including ultrasound examination of the kidneys in B-mode with further renal vessels color Doppler imaging to assess vessels hemodynamics. A contrast-enhanced ultrasound examination of the kidneys was carried out using Sonovue contrast agent at the doses of 2.5 ml (according to the European Good Clinical Practice Recommendations for Contrast-Enhanced Ultrasound) and 0.5 ml (an improved technique of contrast agent intravenous bolus administration).Results. The improved technique (0.5 ml of contrast agent intravenous bolus administration) in comparison with the European Recommendations technique (2.5 ml of contrast agent intravenous bolus administration) used in patients with type 2 diabetes showed no or minor differences in the qualitative and quantitative indicators of contrast-enhanced ultrasound examination which did not affect the interpretation of the results.Conclusion. The improved contrast-enhanced ultrasound examination technique using 0.5 ml of a contrast agent showed its possibilities in diagnosing diabetic nephropathy in patients with type 2 diabetes, and also revealed the potential of an economically beneficial distribution of a contrast agent without losing the quality and information content of the study.

Gynecological Surgeries in COVID-19 Pandemic Era

ABSTRACT Introduction During the coronavirus disease-2019 (COVID-19) pandemic era, different types of emergency gynecological surgeries were performed in the Department of Obstetrics and Gynecology of our tertiary care teaching hospital as per the standard guidelines issued from time to time by the Indian Council of Medical Research (ICMR) and the Federation of Obstetric and Gynecological Societies of India Good Clinical Practice Recommendations (FOGSI GCPR) guidelines for the safety of the patients and healthcare providers. Materials and methods A different variety of gynecological surgeries were performed on cases which were admitted in the Obstetrics and Gynecology ward of Sri Guru Ram Das Institute of Health Sciences and Research, Vallah, Amritsar, with effect from the first lockdown, i.e., March 22, 2020, to the end of lockdown, i.e., May 31, 2020 following standard guidelines for the safety of patients and healthcare providers in the COVID pandemic. The details of these cases are being presented in this article. Results A very few gynecological surgeries were taken up as they could not have been postponed to the post-COVID times. The use of medical and conservative approach to each possible situation has been tremendous. All cases of abnormal uterine bleeding (AUB), endometriosis, and fibroid uterus were continued to be on medical management. All minor diagnostic procedures were done under short general anesthesia with premedication. Conclusion The resumption of regular gynecological work is being regularized in phases. It is a long way before we come back to the original gynecology practice. How to cite this article Bala R, Kumar SS, Khullar U, et al. Gynecological Surgeries in COVID-19 Pandemic Era. AMEI's Curr Trends Diagn Treat 2020;4(2):61–64.

Rehabilitation Before and After Autologous Haematopoietic Stem Cell Transplantation (AHSCT) for Patients With Multiple Sclerosis (MS): Consensus Guidelines and Recommendations for Best Clinical Practice on Behalf of the Autoimmune Diseases Working Party, Nurses Group, and Patient Advocacy Committee of the European Society for Blood and Marrow Transplantation (EBMT)

Autologous haematopoietic stem cell transplantation (AHSCT) is increasingly used to treat people with multiple sclerosis (MS). Supported by an evolving evidence base, AHSCT can suppress active inflammation in the central nervous system and induce long-term changes in immune cell populations, thereby stabilizing, and, in some cases, reversing disability in carefully selected MS patients. However, AHSCT is an intensive chemotherapy-based procedure associated with intrinsic risks, including profound cytopenia, infection, and organ toxicity, accompanied by an on-going degree of immuno-compromise and general deconditioning, which can be associated with a transient increase in functional impairment in the early stages after transplantation. Although international guidelines and recommendations have been published for clinical and technical aspects of AHSCT in MS, there has been no detailed appraisal of the rehabilitation needed following treatment nor any specific guidelines as to how this is best delivered by hospital and community-based therapists and wider multidisciplinary teams in order to maximize functional recovery and quality of life. These expert consensus guidelines aim to address this unmet need by summarizing the evidence-base for AHSCT in MS and providing recommendations for current rehabilitation practice along with identifying areas for future research and development.

Adoption of the ADA/EASD guidelines in 10 Eastern and Southern European countries: Physician survey and good clinical practice recommendations from an international expert panel

AimsEvidence from cardiovascular outcomes trials (CVOTs) of glucagon-like peptide-1 receptor agonists and sodium-glucose cotransporter-2 inhibitors was reflected in the most recent guidelines from the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). The aim of the present study was to assess the adoption of the ADA/EASD guidelines in a convenience sample of physicians from Eastern and Southern Europe, the barriers to the implementation of these guidelines and the measures needed to facilitate their implementation. MethodsAttendees at two international diabetes conferences could volunteer to respond to a fully anonymous survey. Responses were analysed descriptively and a panel of experts from around the region was consulted to interpret the survey results. ResultsResponses (n = 96) from 10 countries were analysed. Most participants (63.4%) considered the ADA/EASD guidelines fundamental to their practice. All respondents saw the value of the CVOT-based ADA/EASD recommendations and 77–80% generally implemented them. Measures suggested to improve adherence to the ADA/EASD guidelines included aligning reimbursement policy with the guidelines (54.4%), publishing guidelines in a simple and concise form (42.4%) and translating guidelines into local languages (33.3%). ConclusionsAligning reimbursement with recent evidence and providing short summaries of the ADA/EASD guidelines in local languages could facilitate physician adherence.

Management of prepregnancy, pregnancy, and postpartum obesity from the FIGO Pregnancy and Non‐Communicable Diseases Committee: A FIGO (International Federation of Gynecology and Obstetrics) guideline

Management of prepregnancy, pregnancy, and postpartum obesity from the FIGO Pregnancy and Non‐Communicable Diseases Committee: A FIGO (International Federation of Gynecology and Obstetrics) guideline