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Guidance Documents

GUIDANCE DOCUMENTS
Please ensure you use this page for all the latest information and guidance.
Guidance documents are renewed as more relevant and up to date information becomes available. Any out of date information will be removed from this page as … Continue reading

NIHR Clinical Trial guide for trainees launched

As part of International Clinical Trials Day 2015, the National Institute for Health Research (NIHR) have launched a new Clinical Trials Guide for Trainee Researchers. .
Clinical trials are considered by many to be the gold standard method for evaluation … Continue reading

Evaluation of the clinical and cost-effectiveness of Short-term Integrated Palliative Care Services (SIPC) to OPTimise CARE for people with advanced longterm Neurological conditions (OPTCARE Neuro).

Summary:
Longterm neurological conditions (LTNCs) are usually progressive conditions, although some have a sudden onset and affect approximately 10 million people in the UK. In the later or more advanced stages those affected can have profound symptoms and problems. Unfortunately their care can be suboptimal. Palliative care has been suggested in NHS policy documents, such as the National Service Framework for LTNCs (quality standard 9), as a way to better help people severely affected by these illnesses. But it has not been rigorously tested, and various different models operate. Usually people only receive palliative care at the very end of life. An alternative to this is Shortterm Integrated Palliative Care(SIPC), which offers support integrated with existing services, does not require patients to be close to death or dying and yet offers short term personalised palliative care, integrated with neurology and rehabilitation services, to improve symptom management and promote patient and family strategies in managing the condition. This approach was tested in a phase II trial for people severely affected by multiple sclerosis. Although some services are starting to provide this type of support it has not been tested more widely. The purpose of this study is to examine the effectiveness and costeffectiveness of SIPC in improving symptoms and quality of life, and reducing hospital utilisation and caregiver burden for people severely affected by longterm neurological conditions (LTNCs). These will include Multiple Sclerosis (MS), Motor Neurone Disease(MND)and Parkinsonism and related disorders. The study will determine whether an earlier referral to palliative care has an effect, whether this effect lessens over time and also when rereferral and or re assessment for palliative care needs should be undertaken. It will also help understand ways in which specialist neurological teams can work most effectively with their local specialist palliative care teams. SIPC stands for ShortTerm Integrated Palliative care, which is a shortterm service usually comprising 3 contacts provided by local specialist palliative care teams, working in an integrated way with neurology and others. SIPC is offered when patients are severely affected by their illness and problems, who are highly complex and are at high risk of hospital admissions with a high need for care. It will be offered by existing Multiprofessional Palliative Care Teams (MPCTs), linked with local neurology and rehabilitation services. The service follows a standard procedure. All staff involved in the study will be provided with a standard manual and trained in advance of the study commencing. These aspects will be refined during the feasibility and setup phase. The MPCT comprises individuals specifically trained in palliative care from (at least) backgrounds in medicine, nursing and psychosocial care or social work. The MPCT has regular multidisciplinary meetings to review patients in their care and is able to visit patients at home in the community. For the purpose of this study, the MPCT will operate a key worker process where a specialist team member will take initial responsibility for a patient referred, although the key worker may change during the course of the intervention. Based on their initial and followup visits and assessments the key worker generates a problem list with the patient and outlines a proposed action plan, agreed with the patient and family (which is thus individually tailored). This might involve a change in symptom management (e.g. drug change), contact with other services, and/or psychosocial support or counselling during the visit. The key worker reviews and revises, at a multiprofessional team meeting, the problem list, their assessment and the action plan to optimise the management of the patient and caregiver and plan future visits and liaises with other professionals, e.g. to agree medication or service change. The key worker liaises regularly and integrates care with neurologists, nurses, rehabilitation, primary and hospice services to discuss patients of concern. We envisage that most patients will be discharged after around 68 weeks, although some (10%) will need continued palliative care involvement.

Inclusion criteria:
Patients 1)Adults (aged 18 years and over) severely affected by advanced or progressive stages of the longterm neurological conditions (LTNCs) of either*: · Multiple Sclerosis (MS) patients with either aggressive relapsing disease with rapid development of fixed disability or those with advanced primary or secondary progressive disease, often with limitation in a number of areas including gait and upper limb function. We do not define referral based on disability but would expect most patients to have an Expanded Disability Status Scale (EDSS)[5] of at least 7.5. · Parkinsonism & related disorders (PRDs) i.e. o Idiopathic Parkinson’s Disease(IPD), Hoehn and Yahr(H&Y)[46] stages 45 OR o Progressive Supranuclear Palsy(PSP) or Hoehn and Yahr(H&Y)[46] stages 35 OR o Multiple System Atrophy(MSA) Hoehn and Yahr(H&Y)[46] stages 35 · Motor Neurone Disease (MND) all stages AND 2)who are deemed (by referring/usual care clinicians) to have: · an unresolved symptom (e.g. pain or another symptom) which has not responded to usual care · AND at least one of the following: unresolved other symptom (e.g. breathlessness, nausea / vomiting, spasticity, fatigue) cognitive problems complex psychological (depression, anxiety, loss, family concerns), communication/information problems and/or complex social needs. AND 3)who are able to give informed consent^, OR where their capacity can be enhanced^ (e.g. with information) so they can give informed consent OR have where a personal consultee^ can be identified and approached to give a opinion on whether or not the patient would have wished to participate in the study. AND 4) are living in the catchment area of the Shortterm Integrated Palliative Care (SIPC) Service We expect patients to be in the advanced or progressive stages of disease. They may be living at home (most common), in a nursing home or in hospital at the time of recruitment. We will develop a proforma for referring clinicians to complete (covering contact and clinical information and important reasons for referral/selection). Caregivers 3) Adults (aged 18 years or over) identified by the patient as the person closest to them, usually a family member, close friend, informal caregiver or neighbour 4) able to give informed consent to complete the questionnaire * Diagnosis must have been established by a specialist neurological assessment ^ When a person lacks capacity to consent for themselves the procedures detailed in the Mental Capacity Act (2005) are adhered to. We will test these inclusion and exclusion criteria in initial feasibility stage and piloting and will propose modifications if required. Inclusion criteria professionals/commissioners qualitative study professionals OR commissioners who are involved in the care of patients with LTNCs Inclusion criteria professionals survey: professionals (of neurology or palliative care services) who are part of a team which is involved in the delivery of the OPTCARE Neuro intervention

Exclusion criteria:
Patients Patients who meet the inclusion criteria but: 1) are already receiving specialist palliative care 2) lack capacity and have no family member, friend or informal caregiver who is willing and available to complete questionnaires about their own and the patient’s symptoms and circumstances We will log all referrals to the trial and map what data we ethically are able to on those who are not included, including reasons for exclusion, where patients who live outside the catchment area are based, those are already receiving palliative care, refusals and those excluded because they lack capacity and have no identifiable personal consultee or informal caregiver. We will test these inclusion/exclusion criteria in initial feasibility stage and propose modifications if required.

Principal Investigator for this trial: Dr Vincent Crosby

Research Ethics Committee Reference: 14/LO/1765

Contact us about participating in this study by emailing R&IActiveStudyEnquiries@nuh.nhs.uk or telephoning 0115 924 9924 Ext. 70076 Continue reading

Evaluation of the clinical and cost-effectiveness of Short-term Integrated Palliative Care Services (SIPC) to OPTimise CARE for people with advanced longterm Neurological conditions (OPTCARE Neuro).

Summary:
Longterm neurological conditions (LTNCs) are usually progressive conditions, although some have a sudden onset and affect approximately 10 million people in the UK. In the later or more advanced stages those affected can have profound symptoms and problems. Unfortunately their care can be suboptimal. Palliative care has been suggested in NHS policy documents, such as the National Service Framework for LTNCs (quality standard 9), as a way to better help people severely affected by these illnesses. But it has not been rigorously tested, and various different models operate. Usually people only receive palliative care at the very end of life. An alternative to this is Shortterm Integrated Palliative Care(SIPC), which offers support integrated with existing services, does not require patients to be close to death or dying and yet offers short term personalised palliative care, integrated with neurology and rehabilitation services, to improve symptom management and promote patient and family strategies in managing the condition. This approach was tested in a phase II trial for people severely affected by multiple sclerosis. Although some services are starting to provide this type of support it has not been tested more widely. The purpose of this study is to examine the effectiveness and costeffectiveness of SIPC in improving symptoms and quality of life, and reducing hospital utilisation and caregiver burden for people severely affected by longterm neurological conditions (LTNCs). These will include Multiple Sclerosis (MS), Motor Neurone Disease(MND)and Parkinsonism and related disorders. The study will determine whether an earlier referral to palliative care has an effect, whether this effect lessens over time and also when rereferral and or re assessment for palliative care needs should be undertaken. It will also help understand ways in which specialist neurological teams can work most effectively with their local specialist palliative care teams. SIPC stands for ShortTerm Integrated Palliative care, which is a shortterm service usually comprising 3 contacts provided by local specialist palliative care teams, working in an integrated way with neurology and others. SIPC is offered when patients are severely affected by their illness and problems, who are highly complex and are at high risk of hospital admissions with a high need for care. It will be offered by existing Multiprofessional Palliative Care Teams (MPCTs), linked with local neurology and rehabilitation services. The service follows a standard procedure. All staff involved in the study will be provided with a standard manual and trained in advance of the study commencing. These aspects will be refined during the feasibility and setup phase. The MPCT comprises individuals specifically trained in palliative care from (at least) backgrounds in medicine, nursing and psychosocial care or social work. The MPCT has regular multidisciplinary meetings to review patients in their care and is able to visit patients at home in the community. For the purpose of this study, the MPCT will operate a key worker process where a specialist team member will take initial responsibility for a patient referred, although the key worker may change during the course of the intervention. Based on their initial and followup visits and assessments the key worker generates a problem list with the patient and outlines a proposed action plan, agreed with the patient and family (which is thus individually tailored). This might involve a change in symptom management (e.g. drug change), contact with other services, and/or psychosocial support or counselling during the visit. The key worker reviews and revises, at a multiprofessional team meeting, the problem list, their assessment and the action plan to optimise the management of the patient and caregiver and plan future visits and liaises with other professionals, e.g. to agree medication or service change. The key worker liaises regularly and integrates care with neurologists, nurses, rehabilitation, primary and hospice services to discuss patients of concern. We envisage that most patients will be discharged after around 68 weeks, although some (10%) will need continued palliative care involvement.

Inclusion criteria:
Patients 1)Adults (aged 18 years and over) severely affected by advanced or progressive stages of the longterm neurological conditions (LTNCs) of either*: · Multiple Sclerosis (MS) patients with either aggressive relapsing disease with rapid development of fixed disability or those with advanced primary or secondary progressive disease, often with limitation in a number of areas including gait and upper limb function. We do not define referral based on disability but would expect most patients to have an Expanded Disability Status Scale (EDSS)[5] of at least 7.5. · Parkinsonism & related disorders (PRDs) i.e. o Idiopathic Parkinson’s Disease(IPD), Hoehn and Yahr(H&Y)[46] stages 45 OR o Progressive Supranuclear Palsy(PSP) or Hoehn and Yahr(H&Y)[46] stages 35 OR o Multiple System Atrophy(MSA) Hoehn and Yahr(H&Y)[46] stages 35 · Motor Neurone Disease (MND) all stages AND 2)who are deemed (by referring/usual care clinicians) to have: · an unresolved symptom (e.g. pain or another symptom) which has not responded to usual care · AND at least one of the following: unresolved other symptom (e.g. breathlessness, nausea / vomiting, spasticity, fatigue) cognitive problems complex psychological (depression, anxiety, loss, family concerns), communication/information problems and/or complex social needs. AND 3)who are able to give informed consent^, OR where their capacity can be enhanced^ (e.g. with information) so they can give informed consent OR have where a personal consultee^ can be identified and approached to give a opinion on whether or not the patient would have wished to participate in the study. AND 4) are living in the catchment area of the Shortterm Integrated Palliative Care (SIPC) Service We expect patients to be in the advanced or progressive stages of disease. They may be living at home (most common), in a nursing home or in hospital at the time of recruitment. We will develop a proforma for referring clinicians to complete (covering contact and clinical information and important reasons for referral/selection). Caregivers 3) Adults (aged 18 years or over) identified by the patient as the person closest to them, usually a family member, close friend, informal caregiver or neighbour 4) able to give informed consent to complete the questionnaire * Diagnosis must have been established by a specialist neurological assessment ^ When a person lacks capacity to consent for themselves the procedures detailed in the Mental Capacity Act (2005) are adhered to. We will test these inclusion and exclusion criteria in initial feasibility stage and piloting and will propose modifications if required. Inclusion criteria professionals/commissioners qualitative study professionals OR commissioners who are involved in the care of patients with LTNCs Inclusion criteria professionals survey: professionals (of neurology or palliative care services) who are part of a team which is involved in the delivery of the OPTCARE Neuro intervention

Exclusion criteria:
Patients Patients who meet the inclusion criteria but: 1) are already receiving specialist palliative care 2) lack capacity and have no family member, friend or informal caregiver who is willing and available to complete questionnaires about their own and the patient’s symptoms and circumstances We will log all referrals to the trial and map what data we ethically are able to on those who are not included, including reasons for exclusion, where patients who live outside the catchment area are based, those are already receiving palliative care, refusals and those excluded because they lack capacity and have no identifiable personal consultee or informal caregiver. We will test these inclusion/exclusion criteria in initial feasibility stage and propose modifications if required.

Principal Investigator for this trial: Dr Vincent Crosby

Research Ethics Committee Reference: 14/LO/1765

Contact us about participating in this study by emailing R&IActiveStudyEnquiries@nuh.nhs.uk or telephoning 0115 924 9924 Ext. 70076 Continue reading

Standards, Procedures and Guidance

Our current standard operating procedures, regulatory standards, guidance documents, templates and forms are regularly updated please ensure that you are using the most current version.
If you need further assistance then please contact our QA/GCP Auditor Melanie Boulter.

Our Clinical Trials Performance

All NHS organisations are required to publish information on clinical trials regarding the 70 day benchmark of recruiting the first patient within 70 days of the valid submission and recruiting to time and target for commercial clinical trials. The pdf … Continue reading

First international InterGroup Study for nodular Lymphocytepredominant Hodgkin’s Lymphoma in Children and Adolescents

Summary:
This European study of nodular Lymphocyte Predominant Hodgkin’s Lymphoma will ascertain whether children with early stage disease [stages IA & IIA] can be managed safely with surgery and little or no chemotherapy. If the disease is completely resected a “Watch and Wait” approach is adopted otherwise patients will receive three cycles of non intensive chemotherapy.

Inclusion criteria:
Inclusion criteria: · Nodular lymphocytepredominant Hodgkin’s lymphoma confirmed by reference pathology. · Initial stage IA/IIA (according to local staging) or relapse stage IA or IIA and residual tumour after relapse biopsy and no additional surgery planned in nLP patients relapsing after surgery alone · Patient aged under 18 years at time of diagnosis · Written informed consent of the patient and/or the patient’s parents or guardian according to national laws In certain European countries very young patients may have to be excluded in order to comply with national laws or formal insurance requirements.

Exclusion criteria:
Exclusion criteria: · Pretreatment of Hodgkin’s lymphoma differing from study protocol · Any extranodal involvement · Inability to fulfil protocol requirements for imaging (CT, MRI, FDGPET) at staging and response assessment · Known hypersensitivity or contraindication to study drugs · Prior chemotherapy or radiotherapy · Current or recent therapy (within 30 days prior to the start of trial treatment) with steroids · Current or recent (within 30 days prior to the start of trial treatment) treatment with another investigational drug or participation in another investigational trial · Other (simultaneous) malignancies · Severe concomitant diseases (e.g. immune deficiency syndrome) · Known HIV positivity · Pregnancy and / or lactation · Females who are sexually active refusing to use effective contraception (oral contraception, intrauterine devices, barrier method of contraception in conjunction with spermicidal jelly or surgical sterile) (except for surgery only. Subsequent exclusion criteria: Patients are excluded from the study after registration if: · Documents or material ascertained before study inclusion show that an exclusion criterion was fulfilled or an inclusion criterion was not met · The patient and/or the patient’s parents or guardian withdraw(s) his/her/their consent to further study participation. If central review results in upstaging above stage IA/IIA the patient is still documented in the scope of the study but not eligible for treatment in the study. The patient’s physician then decides together with the patient/parents or guardian as to the most appropriate therapy. The study chairpersons decide on the exclusion along with the biometrician of the study. Subsequent exclusion of a patient can be requested by a trial site only in writing. Subsequent exclusion of a patient differs from an individual therapy withdrawal. In the latter case the treatment of the patient according to protocol is terminated, but followup and documentation (data collection in the CRF) is continued according to protocol and the patient appears in all relevant analyses.

Principal Investigator for this trial: Dr Sophie Wilne

Research Ethics Committee Reference: 11/EM/0358

Contact us about participating in this study by emailing R&IActiveStudyEnquiries@nuh.nhs.uk or telephoning 0115 924 9924 Ext. 70076 Continue reading

First international InterGroup Study for nodular Lymphocytepredominant Hodgkin’s Lymphoma in Children and Adolescents

Summary:
This European study of nodular Lymphocyte Predominant Hodgkin’s Lymphoma will ascertain whether children with early stage disease [stages IA & IIA] can be managed safely with surgery and little or no chemotherapy. If the disease is completely resected a “Watch and Wait” approach is adopted otherwise patients will receive three cycles of non intensive chemotherapy.

Inclusion criteria:
Inclusion criteria: · Nodular lymphocytepredominant Hodgkin’s lymphoma confirmed by reference pathology. · Initial stage IA/IIA (according to local staging) or relapse stage IA or IIA and residual tumour after relapse biopsy and no additional surgery planned in nLP patients relapsing after surgery alone · Patient aged under 18 years at time of diagnosis · Written informed consent of the patient and/or the patient’s parents or guardian according to national laws In certain European countries very young patients may have to be excluded in order to comply with national laws or formal insurance requirements.

Exclusion criteria:
Exclusion criteria: · Pretreatment of Hodgkin’s lymphoma differing from study protocol · Any extranodal involvement · Inability to fulfil protocol requirements for imaging (CT, MRI, FDGPET) at staging and response assessment · Known hypersensitivity or contraindication to study drugs · Prior chemotherapy or radiotherapy · Current or recent therapy (within 30 days prior to the start of trial treatment) with steroids · Current or recent (within 30 days prior to the start of trial treatment) treatment with another investigational drug or participation in another investigational trial · Other (simultaneous) malignancies · Severe concomitant diseases (e.g. immune deficiency syndrome) · Known HIV positivity · Pregnancy and / or lactation · Females who are sexually active refusing to use effective contraception (oral contraception, intrauterine devices, barrier method of contraception in conjunction with spermicidal jelly or surgical sterile) (except for surgery only. Subsequent exclusion criteria: Patients are excluded from the study after registration if: · Documents or material ascertained before study inclusion show that an exclusion criterion was fulfilled or an inclusion criterion was not met · The patient and/or the patient’s parents or guardian withdraw(s) his/her/their consent to further study participation. If central review results in upstaging above stage IA/IIA the patient is still documented in the scope of the study but not eligible for treatment in the study. The patient’s physician then decides together with the patient/parents or guardian as to the most appropriate therapy. The study chairpersons decide on the exclusion along with the biometrician of the study. Subsequent exclusion of a patient can be requested by a trial site only in writing. Subsequent exclusion of a patient differs from an individual therapy withdrawal. In the latter case the treatment of the patient according to protocol is terminated, but followup and documentation (data collection in the CRF) is continued according to protocol and the patient appears in all relevant analyses.

Principal Investigator for this trial: Dr Martin Hewitt

Research Ethics Committee Reference: 11/EM/0358

Contact us about participating in this study by emailing R&IActiveStudyEnquiries@nuh.nhs.uk or telephoning 0115 924 9924 Ext. 70076 Continue reading

Nottingham University Hospitals is the sixth most active trust in the country for 2011/12

According to figures just released by NIHR, Nottingham’s 293 studies in 2011/12 make it the sixth most research active trust in England. Published in the Guardian’s Healthcare Network section, the data also reveal recruitment for Nottingham at 8,874 patients.

Standard Operating Procedures

Please refer to this page frequently to ensure the correct SOP is used
To access templates and forms associated with individual SOPs please refer to Templates and Forms.
All links in this section are direct downloads for pdfs
R&I have reviewed … Continue reading

CLAHRC Briefing on Supporting Adoption of Evidence into Practice

The latest bulletin from MeReC (part of the NHS National Prescribing Centre) provides a summary of some of the leading knowledge on implementation and adoption. Three approaches are described for introducing new evidence into practice: Let it happen, Make it happen and Help it happen. There’s also an important reminder that failure to use evidence leads to inefficiency and a reduction in both the quality and quantity of life for patients. Continue reading

IRAS e-submission process during new CSP module roll out

A new version of CSP software (the CSP Module) was launched last year in two phases. This phased approach means there are currently two ways to submit your application to CSP through IRAS depending on the version of IRAS your project was created in. This briefing helps you navigate the process. Continue reading

CLAHRC Briefing on Innovation, Health & Wealth

This CLAHRC NDL briefing concerns recent policy developments in Innovation Health & Wealth. Learn about important changes and plans in this easy to consume summary, together with links to the full details if you need to delve more deeply. This briefing outlines the eight priority areas for improvement and succinct descriptions of the High Impact Innovations which should be introduced with
immediate effect.
Continue reading

Hazel’s empowering journey as an asthma patient on a clinical trial: Patient experience video

In this video, Hazel describes her empowering journey as an asthmatic clinical trial participant and explains that wanting to give back was a major aspect of her decision to take part. Hazel emphasises: “The days when treatment is just given because that’s the way we’ve always done it should be well gone now. Research, in an age where money is important, is coming up with cost-effective ways and that should be important to us all.” Continue reading

New £60 million Clinical Practice Research Datalink to build unique position for UK health research

The Department of Health’s National Institute for Health Research (NIHR) in partnership with Health and Medicines and Healthcare products Regulatory Agency (MHRA) has announced the creation of a new Clinical Practice Research Datalink service (CPRD).

The CPRD will provide capability, products and services across a number of areas. The new service will be developed over four years from April 2012 and will eventually incorporate data from Scotland, Wales and Northern Ireland. Continue reading

New 2010/11 NIHR Annual Report features Nottingham revolutionary controlled release antibiotic pellet for ear surgery

The NIHR’s annual report for 2010/11 has just been published and features the Nottingham Biomedical Research Unit in Hearing and its work with the University of Nottingham to produce a revolutionary controlled-release antibiotic pellet. Continue reading

Regulatory Standards

Below is a selection of links related to regulatory standards which are relevant to Healthcare research in the UK. If you cannot find what you are looking for then please contact us on 0115 9709049.

General

Research Governance Framework, 2nd ed

Legislation & … Continue reading

Model Agreements

Model Agreements
Nationally approved standard Agreements help speed up the contracting process for industry-sponsored trials carried out in the NHS by removing the need for site-by-site reviews and local legal agreements to be drawn up. This enables trials to start … Continue reading

A new guide to NUH R&D finance processes

A comprehensive guide to NUH R&D finance has been written, collated and published by our Corporate Finance Manager Paul Barnett. Available on this site, it includes valuable information for anyone needing to cost a project and go though the financial … Continue reading

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