Multidisciplinary Advice Research Articles

Clinical, methodology, and patient/carer expert advice in pediatric drug development by conect4children.

Many medicines are used "off-label" in children outside the terms of the license. Feasible pediatric clinical trials are a challenge to design. Conect4children (c4c) is an Innovative Medicines Initiative project to set up a pan-European pediatric clinical trial network aiming to facilitate the development of new medicines for children. To optimize pediatric trial development by promoting innovative trial design, c4c set up a European multidisciplinary advice service, including the voice of young patients and families, tailored to industry and academia. A network of experts was established to provide multidisciplinary advice to trial sponsors. Experts were selected to join clinical and innovative methodology expert groups. A patient and public involvement (PPI) database, to include the expert opinion of patients and parents/carers was formed. A stepwise process was developed: (1) sponsors contact c4c, (2) scoping interview takes place, (3) ad hoc advice group formed, (5) advice meeting held, and (6) advice report provided. Feedback on the process was collected. Twenty-four clinical and innovative methodology expert groups (>400 experts) and a PPI database of 135 registrants were established. As of September 30, 2022, 36 advice requests were received, with 25 requests completed. Clinical and methodology experts and PPI representatives participated in several advice requests. Sponsors appreciated the advice quality and the multidisciplinary experts from different countries, including experts not known before. Experts and PPI participants were generally satisfied with the process. The c4c project has shown successful proof of concept for a service that presents a new framework to plan innovative and feasible pediatric trials.

P597 Bone mineral density in patients after total proctocolectomy and pouch surgery due to Ulcerative Colitis have low bone mineral density, and low performance of DXA scans- a cross sectional study

Abstract Background The reported prevalence of low bone mineral density (BMD) in patients with inflammatory bowel diseases (IBD) varies between 20–50%. The multiple contributing factors include inflammation,use of corticosteroids, life style and diet.Patients with ulcerative colitis (UC) undergoing proctocolectomy with ilealpouch-anal anastomosis (IPAA) commonly develop pouchitis-de novo inflammation in previously normal small bowel, which may resemble Crohn’s disease (CD). We aimed to assess rate of low BMD in patients with a pouch and rate of DXA performance. Methods Patients after IPAA due to UC were prospectively followed; Questionnaires regarding demographic, disease course, surgery, diet and blood tests were collected biannually. BMD was assessed by dual-energy x-ray absorptiometry(DXA).All medical records were reviewed for DXA performance within the last five years, if not found-patients were contacted and submitted the results. Low BMD was defined as T score < -1. Results Out of 146 prospectively followed patients, data regarding DXA was available for 114; 70 (61%) women. Median age 46 (IQR 38–67), median age at UC diagnosis 21 years (IQR 15.7–29.5), median pouch age 16 years (IQR 8.5–22.5). DXA scans were performed in 41/114 patients (36%), low BMD was noted in 68.3 %: osteopenia- 16 (39%), osteoporosis: 12 (29.3%). Patients performing DXA scan were older: 54 (IQR 42–64) vs. 45 years (IQR 31–54) (p=0.012), and were diagnosed with UC at younger age: 23 (IQR 17–29) vs. 19 years (IQR 14–26) (p=0.018). Smoking, UC duration prior to IPAA, indication for surgery, pouch age and pouchitis were comparable between patients who performed and did not perform DXA scans. In patients with low BMD- current smoking rates were higher compared to those with normal BMD:4 (14.3%) vs. 0 (p=0.008),respectively. Vitamin D levels in patients with low and normal BMD were comparable:22.8 (IQR 17.5–26) vs. 20 (IQR 16.8–21.8)ng/ml (p=0.158), respectively. Vitamin D supplementation was comparable as well [38% vs. 60% (p=0.16)]. No differences in micronutrients consumption between the groups were noticed. Conclusion In a prospective cohort of patients after IPAA due to UC, approximately 36% performed DXA scans and the majority of them had low BMD, with smoking as a potential risk modifier. Due to high rates of low BMD in this population multidisciplinary advice and follow up should be provided to address the low performance of DXA scans and the abnormalities in BMD.

An exploration of the Personal Relationship Advisory Group in a community learning disability service: A service development project

Accessible summary The project aimed to explore discussions from the Personal Relationship Advisory Group (PRAG) meetings in a community adult learning disability team to influence the development of new relationship resources. All meeting minutes within a 12‐month period were analysed to find themes. The themes suggest the importance of the service looking at the whole person, such as their physical, emotional and social well‐being, when there are relationship concerns. New resources that focus on personal sexuality, different types of relationships and Internet safety may be of benefit to the service. Resources for carers may also be useful, such as helping carers to support people with learning disabilities to safely access relationships online. AbstractBackgroundAdults with learning disabilities often face barriers when accessing relationships and can require additional support. The Personal Relationship Advisory Group (PRAG) is a provision in a community learning disability service in North England, which offers multidisciplinary advice regarding relationship concerns. The current project aimed to identify common themes within PRAG to influence the development of new resources in the service.Materials and MethodsAll meeting minutes within a 12‐month period were analysed using thematic analysis. There were a total of 16 minutes, which discussed 11 people with learning disabilities. This included six females and five males with a mean age of 30 (SD = 14.97).ResultsIndividuals often had limited opportunity to develop relationships. There was a lack of understanding of sex and of how to behave appropriately in different types of relationships, with a need for individualised, accessible education. The Internet was commonly used to seek relationships, with many concerns regarding safety from carers or family. There were some unhelpful responses from others, such as the implementing of restrictions. Factors that may have an impact on the person's overall well‐being, such as their health, social issues and trauma, were often discussed.ConclusionsThe identified themes suggest the need for the service to take a holistic, biopsychosocial and individualised approach when supporting individuals with any relationship concerns. A multidisciplinary approach and collaboration with the individual and family/carers is key. It may be useful for the service to develop resources on topics such as personal sexuality, different types of relationships and Internet safety. Carer‐specific resources would also be beneficial, such as advice on how to safely support individuals to seek relationships on the Internet.

SARS-CoV-2 Shedding in Dialysis Patients With COVID-19

SARS-CoV-2 Shedding in Dialysis Patients With COVID-19

Evaluation of Clinical Trials in Onco-haematology: A New Method Based on Risk Analysis and Multidisciplinarity.

European member states are increasingly vying with one another to recruit patients for clinical trials (CTs). The French national agency for medicines (ANSM) now receives an ever-growing number of CTs, extending response times. The aim of the new methodology presented herein is to reduce assessment times below the national mandatory timeframe of 60days and to improve patient safety. Based on an analysis of the criteria defining CTs, 4 key points were identified (safety, fragile population, loss of opportunity, design complexity) to build a criticality score which would determine evaluation type. This score also determines the resources needed (complete evaluation, multidisciplinary advice, ad hoc evaluation) and the timeframe required for appropriate analysis. All post-phase I CTs were analysed from the implementation of the new assessment method, on 01/02/2018 through to 31/12/2019. 447 CTs were analysed (63% industry and 37% academic sponsors). Based on a criticality scale, 27% of the CTs received a type A evaluation (complete), 37% a type B (multidisciplinary evaluation), 23% a type C evaluation (ad hoc evaluation) and 13% a type D evaluation (fast evaluation). From 2014 to 2017, 37% of the CTs were analysed within the mandatory timeframe, with a mean of 68days, reaching a maximum of 102days in 2017. Using this new assessment method, 92% of CTs respected the mandatory timeframe in 2019; the mean time in 2018-2019 was 34days; Grounds for Non-Acceptance (GNA) were raised for 66% of the CTs (69% from academic sponsors and 65% from industrial firms). 3 CTs were refused. Here, we demonstrate the feasibility of risk analysis and multidisciplinarity method, which resulted in a dramatic improvement of assessment times.

Computerized registry as a potential tool for surveillance and management of complex bone and joint infections in France: French registry of complex bone and joint infections.

AimsThe French registry for complex bone and joint infections (C-BJIs) was created in 2012 in order to facilitate a homogeneous management of patients presented for multidisciplinary advice in referral centres for C-BJI, to monitor their activity and to produce epidemiological data. We aimed here to present the genesis and characteristics of this national registry and provide the analysis of its data quality.MethodsA centralized online secured database gathering the electronic case report forms (eCRFs) was filled for every patient presented in multidisciplinary meetings (MM) among the 24 French referral centres. Metrics of this registry were described between 2012 and 2016. Data quality was assessed by comparing essential items from the registry with a controlled dataset extracted from medical charts of a random sample of patients from each centre. Internal completeness and consistency were calculated.ResultsBetween 2012 and 2016, 30,607 presentations in MM were recorded corresponding to 17,748 individual patients (mean age 62.1 years (SD 18.4); 10,961 (61.8%) males). BJI was considered as complex for 63% of cases (n = 19,355), and 13,376 (44%) had prosthetic joint infections (PJIs). The controlled dataset, available for 19 centres, included 283 patients. Global consistency and completeness were estimated at 88.2% and 88.9%, respectively, considering missing items in the eCRFs as negative results.ConclusionThis national registry is one of the largest prospective databases on BJI and its acceptable data quality parameters allow further use for epidemiological purposes.Cite this article: Bone Joint Res 2020;9(9):635–644.

Emergency preparedness, resilience and response guidance for UK hospital transfusion teams.

ObjectivesTo present Emergency Preparedness, Resilience and Response (EPRR) guidance for Hospital Transfusion Teams on behalf of the National Blood Transfusion Committee emergency planning working group.BackgroundThe Civil Contingencies Act 2004 requires healthcare organisations to demonstrate that they can deal with major incidents while maintaining critical services. Recent mass casualty events and the use of transfusion‐based resuscitation have highlighted the evolving role of the Hospital Transfusion Team.MethodsThis multi‐disciplinary advice is informed by recent global and national experience, the 2018 NHS England clinical guidelines for Major Incidents, and stakeholder workshops.GuidanceTransfusion staff should be familiar with local EPRR plans including casualty type and numbers. Staff should be exercised as part of wider Trust preparation, with documented roles and responsibilities. Transfusion support should be proactive and include blood issue, regulatory compliance and sample handling. Robust LIMS‐compatible emergency identification systems are essential to minimise errors. Emergency stock management requires rapid assessment of existing stock and estimated demand before re‐ordering. Initial demand should be based on 2 to 4 red blood cells (RBC) per patient admitted. Patients with significant haemorrhage may require further red cells and early haemostatic support. Where “universal” components are demanded, they should be gender appropriate. Senior staff should lead the response, log and communicate key decisions, and prepare for post‐incident recovery.ConclusionsTransfusion teams have an important role in ensuring continuity of transfusion support. Teams should develop their EPRR plans based on local plans and national guidance. Emergency preparedness should include post‐incident debriefing for ongoing staff support and future service improvement.

An ACT and physiotherapy group for adolescents experiencing chronic pain

A pain management group using acceptance and commitment therapy (ACT) principles combined with physiotherapy exercises in the Child and Young People’s Adolescent Clinic is presented. Seven 11/2 hour sessions were run, including interactive learning on key ACT principles and discussion around values and goals. Evaluation demonstrates multiple benefits, including creating a safe space to share the struggles of living with chronic pain, access to multidisciplinary advice, and support from other young people.Image: ‘Weird Monster Creature Party’ by Qubodup. Public domain. Courtesy of Open Clip Art Library.

Prescriptions hors AMM supervisées de méthylphénidate dans le TDAH de l’adulte

ObjectiveOff-label prescription is a common practice in psychiatry, raising health and economic concerns. Collegial consultation could allow a framed prescription of treatments that are not authorized in specific indications. Attention Deficit Hyperactivity in adult populations (ADHD) is a striking example of a pathology where off-label prescription is frequent. First considered to be a childhood disorder, the awareness of this condition in adults is increasing, leading to the development of new clinical practices and treatments. However, the adult ADHD diagnosis and its management are still emerging in France despite a high prevalence. Treatment of adult ADHD relies on methylphenidate prescription, but the initiation of this drug is not authorized in adult populations. Methylphenidate is a central nervous system stimulant that is structurally close to amphetamine and acts as a norepinephrine and dopamine reuptake inhibitor. Due to these pharmacological properties, neuropsychiatric and cardiovascular side-effects could occur. Furthermore, its addictive potential has led France to classify it as a psychoactive drug, dispensed via secured prescription. The first prescription and the one-year follow-up are restricted to neurologists, paediatrics, psychiatrists and sleep disorders specialists at hospital. The objective of this article is to propose a multidisciplinary framework for the off-label prescription of methylphenidate in adult ADHD. MethodsThe Multidisciplinary Advice Consultation for Exceptional Addiction Treatments (Consultation d’Avis Multidisciplinaire de Traitements d’Exception en Addictologie CAMTEA) was first set up in Lille for the prescription of baclofen in alcohol dependence and was then extended to topiramate in binge eating disorder. This procedure has been adapted to the particularities of ADHD in adult populations, the differential diagnosis (bipolar disorder, depressive disorder, anxious disorder, personality disorder, substance use disorder) and the co-morbidities requiring a full psychiatric and neuropsychological assessment. Moreover, a particular attention has been paid to the monitoring of neuropsychiatric, cardiovascular and misuse risk because of the potential side-effects of methylphenidate. ResultsThe proposed prescription framework is structured into several specialized consultations. A first psychiatric evaluation aims to diagnose adult ADHD, using the French version of the Diagnostisch Interview Voor ADHD 2.0 questionnaire (DIVA 2.0), and to assess the quality of life impact with the Weiss Functional Inventory Rating Scale (WIFRS). It also searches for the presence of differential diagnosis or co-morbidities. The second appointment consists of a pharmacological evaluation that aims to search for contraindications and potential drug interaction. A neuropsychological evaluation based on standardized tests (Weschler Adulte Intelligence Scale [WAIS IV], Conner's Continuous Performance Test 3 [CPT] and the Minnesota Multiphasic Personnality Inventory [MMPI]) is also required to evaluate neurocognitive disabilities and personality features. Once the parameters of the different assessments have been collected, the synthesis is presented during a multidisciplinary meeting in order to assess the risk-benefit ratio for each patient. Several specialties are involved in this multidisciplinary meeting: psychiatry, addictology, general medicine, addictovigilance, pharmacovigilance and neuropsychology. One strategy among three possibilities can be decided: (1) contraindication to treatment with methylphenidate, (2) attention deficit disorder that does not require medication management, and (3) indication of treatment with methylphenidate with the choice of the pharmacological form (immediate or prolonged release). A biological check-up and an electrocardiogram are carried out systematically before any treatment. If the decision is made to initiate treatment, it is started at the lowest dosage and followed by a titration phase. A weekly follow-up is carried out during the titration phase in order to assess treatment efficacy and safety. After treatment stabilization, the general practitioner can carry out the renewal, and the patient will be reassessed within the framework of the multidisciplinary consultation every 3 months. ConclusionWhen an off-label prescription is being considered, it must comply with the basic rules of good clinical practice, and the benefit/risk ratio should be constantly reassessed. The proposed multidisciplinary framework, adapted to the characteristics of adult ADHD and the pharmacological properties of methylphenidate, appears to be an interesting strategy to meet the requirements of the good clinical practice. The complementary assessments carried out and the collegial framework allow enhancing the patient's follow-up and minimize the drug risk, particularly in the psychiatric, addictive and cardiovascular adverse events. Finally, this framework could also help the monitoring of other off-label treatments for ADHD, such as atomoxetine or guanfacine.

Genetic Predictors of ≥5% Weight Loss by Multidisciplinary Advice to Severely Obese Subjects

Background: Weight loss success is determined by genetic factors, which may differ according to treatment strategy. Methods: From a multidisciplinary obesity treatment program involving dietary advice, psychological counseling, and increased physical activity, 587 subjects (68% female; 46.1 ± 12.4 years; BMI 39.9 ± 6.3) were recruited. At baseline, a blood sample was drawn for DNA isolation. Genotypes were determined for 30 polymorphisms in 25 candidate genes. The association between genotypes and weight loss was assessed after 3 months (short-term) and after 12 months of treatment (long-term). Weight loss was categorized as ≥5% or <5% of initial weight. Results: The G/G genotype of PLIN1 (rs2289487) and PLIN1 (rs2304795), the T/T genotype of PLIN1 (rs1052700), and the C/C genotype of MMP2 predicted ≥5% weight loss in the first 3 months. The C/G-G/G genotype of PPARγ (rs1801282) and the T/C genotype of TIMP4 (rs3755724) predicted ≥5% weight loss after 12 months. Subjects with the combination of PPARγ (rs1801282) C/G-G/G and TIMP4 (rs3755724) T/C lost even more weight. Conclusion: Polymorphisms in genes related to regulation of fat storage and structural adaptation of the adipocytes are predictors for weight loss success with different genes being relevant for short-term and long-term weight loss success.

Cuidados paliativos: la opción para el adulto en edad avanzada

An important area for improvement in palliative care for the elderly is highlighted, with a range of possibilities proposed to implement care according to the patient's life situation. This is based on the patient's needs and aims to preserve the quality of life, dignity and rehabilitation of the patient, as well as to reduce the burden for the family. For this, consideration should be given to the fact that the elderly are faced with a gradual and progressive decline as they get older and sicker, and that they need this type of care to provide control of the physical, psychological, social and spiritual symptoms. Furthermore, challenges must be met to develop these actions with promotion, prevention and encouragement. It is necessary to ensure that the elderly and their families receive home-based care and multidisciplinary advice.

Observatoire des tumeurs malignes rares gynécologiques

The observatory of gynecological rare tumors (TMRG) has been initially created for ovarian rare neoplasms (TMRO). Because of the similarities between ovarian and other gynecological tumors, this observatory has been then extended to all gynecological rare tumors. The recognition by INCa of three national expert centers (centre Léon-Bérard, hôpitaux de Paris, institut Gustave-Roussy) in rare gynecological cancers and a network of regional expert centers in 2010, expend the experience of the website "Observatoire francophone des tumeurs rares de l'ovaire". The major goals of this gynecology rare tumors experts network, are to promote systematic second opinion for initial diagnostic by experts in gynecopathology, systematic multidisciplinary advice by surgeons and medical oncologist experts, to disseminate clinical guidelines dedicated to rare gynecological tumors, to promote specific fundamental and translational research within clinical trials dedicated to rare tumors. At the end, we would like to improve benefit in term of survival and/or fertility for all these potential young patients.

Implementation of multidisciplinary advice to allied health care professionals regarding the management of their patients with neuromuscular diseases

Purpose. Patients with neuromuscular diseases (NMDs) do not always receive appropriate allied health care. This is partially because of the large heterogeneity among these conditions, some of which are quite rare. Individual allied health care professionals, therefore, have relatively little opportunity to develop relevant experience with these patients. To overcome this problem, we developed specialist multidisciplinary advice regarding management of patients with NMD for occupational therapy (OT), physical therapy (PT) and speech therapy (ST) in a primary care or rehabilitation setting. The aims of the study were to explore to what extent this allied health care advice was implemented with a focus on the amount of therapy received and to explore possible barriers to implementation.Methods. One-hundred two patients visited the Neuromuscular Centre Nijmegen for OT, PT and ST consultations. Integrated allied health care advice was written on the basis of these consultations and a multidisciplinary meeting. All patients, their therapists and rehabilitation physicians received this advice. Following the advice, questionnaires were sent out at baseline and at 6 months follow up, collecting data on implementation of the amount of therapy suggested and on possible barriers for adherence.Results. Advice for ST and OT was fully implemented in primary care, but only partially (58%) in a rehabilitation setting. Advice to reduce the amount of PT was implemented in only 15% of the cases. Possible barriers were related to the advice itself (feasibility of treatment duration, correctness and completeness), the patient (motivation) and the professional (experience in treatment of NMDs). Therapists expressed a desire to have the opportunity to discuss the treatment advice with the multidisciplinary team.Conclusions. The extent to which multidisciplinary advice was implemented differed for OT and ST compared to PT and for the setting (primary care or rehabilitation). Possible barriers were identified at different levels. We recommend follow-up telephone calls to provide therapists opportunity for discussion.

Referral of patients with neuromuscular disease to occupational therapy, physical therapy and speech therapy: Usual practice versus multidisciplinary advice

Purpose. To compare the volume of occupational therapy (OT), physical therapy (PT) and speech therapy (ST) as currently received by patients with neuromuscular diseases with the volume of OT, PT and ST recommended by a multidisciplinary team.Method. The use of OT, PT and ST was studied retrospectively and prospectively in a reference group (n = 106) receiving usual care and in an intervention group (n = 102) receiving advice based on multidisciplinary assessments. A cost analysis was made and the implementation of the advice was evaluated at 6 months.Intervention. Multidisciplinary assessments consisted of a single consultation by OT, PT and ST each, followed by a multidisciplinary meeting and integrated advice.Outcome variables. Volume (frequency times duration) of therapy, relative over- and underuse of therapy and costs of therapy and intervention.Results. Compared to the multidisciplinary advice, there was 40% underuse of OT among patients with neuromuscular disease. For PT, there was 32% overuse and 22% underuse; for ST, there was neither over- nor underuse. Some 40% of patients received once-only advice regarding ST compared to 27% regarding OT and 19% regarding PT. The costs of the multidisciplinary advice were estimated at €245 per patient. If fully implemented, our multidisciplinary approach would result in a mean cost savings of €85.20 per patient. The recommended therapy had, however, been implemented only partially at 6 months follow-up.Conclusions. Some patients with a neuromuscular disease do not receive any form of allied healthcare, whereas they should. Among patients with neuromuscular disease who do receive some form of allied healthcare, quite a few receive these treatments for too long periods of time. Ways need to be developed to improve implementation of the multidisciplinary advice and to obtain a more favourable balance between its costs and benefits.

Does a specialist voice clinic change ENT clinic diagnosis?

General ENT clinics lack the high quality diagnostic equipment and multidisciplinary advice that is available in the voice clinic. We wished to find out if referral to a specialist voice clinic from general ENT consultant clinics resulted in a change in diagnosis. Lists of voice clinic attendees were reviewed between January 2003 and May 2004. Notes were obtained for 20 patients who attended voice clinic after referral from a general ENT clinic: 3 had no diagnosis on referral to voice clinic, a diagnosis was given after attendance; 8 had their referring diagnosis changed by attendance; and 9 had no change. The voice clinic adds diagnostic value to the service available in general ENT clinics.

A prospective study of the workload of a newly formed PEG advice team.

A multidisciplinary advice team may be the optimal way of providing the long-term nutritional and percutaneous endoscopic gastrostomy (PEG)-related care for patients dependent on PEG feeding but the workload involved is unknown. To study prospectively the workload of a proactive, multidisciplinary PEG advice team over a 2-year period. Separate documentation from main case notes of each episode of the team's contact with PEG or potential PEG patients, including assessment, advice and therapy given, from the time of its establishment, for four consecutive 6-monthly periods. During the audit, 89 patients were referred to the team for consideration of PEG insertion and PEGs were placed in 74. Eighty-nine additional patients were referred for follow up having had a PEG placed elsewhere. During the four audit periods the rate of new PEG insertions increased by 53%, the rate of PEG replacements by 315%, and the number of patients under the team increased from 16 to 70, an increase of 337%. Numbers of inpatient and outpatient consultations, and visits to other institutions by members of the team increased commensurately. The rapidly increasing workload of the team suggests it is playing a valued role but there are significant resource implications.

Essential skills for purchasing — The views of directors of public health andhealth authority chief executives

Since the NHS reforms, health authorities have been purchasing health care and have been advised that publichealth considerations must inform all NHS activities, and that the Director of Public Health must be supported by a team of qualified support staff. This survey of directors of public health and health authority chief executives in England shows the skills currently available to support health authority purchasing, and the perceived importance of this wide range of skills to the purchasing process. Future models of purchasing will need to ensure access by purchasers to public health and multi-disciplinary advice.