SemaFoRe: Semantic Feature and Repetition therapy in aphasia: A pilot RCT

MUMS 4 MUMS: structured telephone peer support for women experiencing postnatal depression. Pilot and exploratory RCT of its clinical and cost effectiveness

Limbs Alive: Use of computer games to provide motivating, child centred therapy to improve bimanual skills for children with hemiplegic cerebral palsy.

A randomised controlled trial of total resurfacing versus hemi resurfacing in the treatment of primary osteoarthritis of the shoulder.

The Stroke Oxygen Supplementation (SOS) study

Diet and Physical Activity to Prevent Recurrence of High Risk Adenomas: A feasibility study

A prospective, randomised controlled trial to determine the safety and efficacy of steroid impregnated tape compared to standard therapy with silver nitrate in the treatment of over-granulating peritoneal dialysis catheter exit sites.

Improving GHB withdrawal with baclofen

Pilot Study to Enhance Recovery Through Physical Activity and Healthy Lifestyles in an Acute Psychiatric Day Hospital Setting

IMPROVE-Stroke: IMproving the PRevention Of Vascular Events after Stroke or TIA – a randomised controlled pilot trial of nurse independent prescriber-led care pathway-based risk factor management

Does early targeted trunk training improve mobility outcome at 6 months for patients who are unable to sit unsupported at admission? A mixed method feasibility study

Support for computerised therapy for patients with depression/anxiety: a factorial randomised controlled comparison of brief vs. enhanced support given by clinicians vs. assistants

<b>PB-PG-0909-20226 – NIHR Research for Patient Benefit Programme – Final report</b><br /> <br /> <b>Project title: </b>The Interhospital Telemedicine Pilot Project<br /> <br /> <b>Authors: </b>Professor Linda Hands - University of Oxford<br /> Dr Malcolm Clarke -&nbsp; Brunel University London<br /> Dr Grizelda George - Horton General Hospital<br /> Professor Russell Jones - Chorleywood Health Centre<br /> Dr James Kennedy - University of Oxford<br /> Dr Rajesh Kharbanda - Oxford Radcliffe Hospitals NHS Trust<br /> Dr Rick Pullinger -&nbsp; University of Oxford<br /> <br /> <br /> <b>Plain language summary</b><br /> <br /> Patients in a District General Hospital (DGH) Emergency department sometimes need input from specialists in the nearest teaching hospital. The DGH doctor usually rings the specialist with their findings but the quality of this information depends on the skill and experience of the DGH doctor who is often a trainee. Video conferencing between the patient and specialist might improve the information available to the specialist and enable them to confidently advise on local treatment in the DGH or transfer. We planned&nbsp; to test the use of video conferencing across all patients presenting to a DGH Emergency department (Horton General Hospital ED) who needed a specialist opinion to see if it was a useful in deciding whether or not a patient should be transferred to the nearest teaching hospital, in Oxford and whether patients and medical staff were happy using it.&nbsp;<br /> The study was designed in two 6 month time periods for comparison before and after introduction of video conferencing. During the first 6 months we collected details on all patients who were transferred to Oxford and admitted to HGH. We found that most patients were referred to a small number of teams in Oxford. We collected details of the patients involved and had meetings with each of the specialist teams to see how videoconferencing could help. We found that there were already clear patient pathways which ensured that appropriate patients were transferred to Oxford and that in most cases videoconferencing had little to offer. We looked at the number of patients who might be helped and it was too small to make this a regular part of doctors’ work. It was unlikely that occasional use of video-conferencing would happen unless there was a clear and immediate benefit from it. There was also an issue over the type of videoconferencing equipment to be used. Large screens were difficult to use in the confined space of the ED but smaller devices (tablets, I-Pods etc) could be easily removed from the department and would need regular replacement. For all the reasons given above, we decided to bring the study to an end before starting the second 6 months because it was clear that, in an Emergency department which was well supported by guidelines for the management of difficult patients, able to rely on phone calls with specialist teams and able to transfer X-Rays and photographs to Oxford for discussion, video conferencing had little to offer and was unlikely to be used.<br /> <br /> <b>Keywords</b><br /> Emergency, telemedicine, DGH, specialist, plastic surgery, OMF, ENT<br /> <br /> <b>Summary of research findings</b><br /> <br /> Background<br /> Tertiary level specialist input may be needed for patients in a District General Hospital (DGH) Emergency department to help with diagnosis or to provide complex care beyond DGH capacity. Communication is usually by telephone and decisions based on reported history, examination and preliminary investigations often performed by a junior trainee. The specialist has few options for further reliable information at this stage and there is pressure to make a quick decision. The safest option is usually patient transfer to the tertiary centre but that interrupts continuous care of the patient, removes them from full resuscitation facilities during transfer and isolates them from family and friends. Inappropriate transfer also wastes resources in the tertiary centre and ambulance service. There are other patients in whom the need for early specialist input goes unrecognised and, as a result, they do badly.<br /> These difficulties in interhospital communication and patient transfer might be helped by use of real time video conferencing (‘telemedicine’) between patient and local clinician at one end and specialist clinician at the other. This could confirm the need for transfer but allow it to be timed more appropriately or support continued care in the secondary care hospital.&nbsp;<br /> Telemedicine, using videoconferencing, has allowed major Emergency departments to provide support for smaller units in remote settlements and for minor injury units. Tertiary level specialities have set up their own telemedicine services, particularly in cardiology and stroke medicine.&nbsp;<br /> Our hypothesis was that telemedicine facilities were likely to be more useful in the DGH Emergency department if used flexibly across a range of conditions to communicate with specialist care. We set up a pilot study using a single DGH Emergency department, at Horton General Hospital, Banbury, which transfers approximately 800 patients per year to specialities in Oxford.&nbsp;<br /> <br /> Aims<br /> To determine whether use of real time videoconferencing for all specialist consultations between the HGH ED and Oxford:<br /> 1. was feasible.<br /> 2. was acceptable to patients and clinicians<br /> 3.had potential to improve patient safety and reduce waste of resources.<br /> <br /> Objectives<br /> The study was designed as an observational study 6 months before and after installation of video conferencing.<br /> In the first 6 month phase details were collected prospectively on all patients presenting to HGH Emergency department requiring specialist advice from Oxford or who were admitted to HGH. The presenting problem and speciality involved was recorded. Data was collected on their subsequent pathway, length of stay and outcome (discharge or death in hospital).<br /> A series of discussions were held with HGH and Oxford based clinicians most frequently involved regarding the precise design of the telemedicine intervention<br /> <br /> The study was curtailed at the end of Phase 1 for reasons detailed below.<br /> <br /> Findings<br /> Between 16th January and 15th July 2012 18,799 patients were seen in HGH ED. Of these 413 were transferred to the John Radcliffe Hospital in Oxford and 3659 were admitted directly to HGH.<br /> <br /> Table 1. Transfers from HGH ED to Oxford<br /> Speciality No patients<br /> Plastic surgery 98<br /> Ophthalmology 88<br /> ENT 75<br /> Paediatrics 39<br /> Oral&amp;Maxillofacial surgery 32<br /> Neurology 19<br /> Vascular Surgery 15<br /> Urology 13<br /> Stroke Medicine 10<br /> Cardiac Medicine &nbsp; 9<br /> Trauma &nbsp; 7<br /> Renal Medicine &nbsp; 2<br /> Colorectal Surgery &nbsp; 1<br /> Gynaecology &nbsp; 1<br /> Miscellaneous &nbsp; 4<br /> TOTAL 413<br /> <br /> Data on speciality under which HGH admissions occurred were analysed for the first 3 months of this period (1539 patients) and showed that the following were most common:<br /> Speciality No.Patients % Total<br /> General Medicine 373 24.24<br /> General Paediatrics 213 13.84<br /> Gerontology &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; 162 10.53<br /> Cardiology &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; 142 &nbsp; 9.23<br /> Chest Medicine 123 &nbsp; 7.99<br /> &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; 1013 &nbsp; 65.83.<br /> <br /> Hardware:&nbsp;<br /> We had a Polycom trolley mounted video conferencing unit available which could be moved to the patient’s trolley in the ED to provide the clinician in Oxford with a high resolution image of the patient via a controllable unit mounted camera. It became clear from observation and discussion that moving such a large unit into a confined cubicle area would take time and effort with associated inconvenience to staff. It could only be justified if there was a clear and immediate benefit to patient management. We therefore looked at alternative technology for providing video-conferencing and considered tablets, I-phones and I-pods.<br /> Information Intervention:<br /> 1. Plastic surgery/ OMF Surgery<br /> Most transfers relate to facial or hand fractures. There are protocols for which patients to transfer and most decisions regarding these are based on radiology images which are accessed easily from both HGH and Oxford.<br /> Most facial lacerations are sutured at HGH and there are guidelines on transfer. There appears to be no advantage to transmitting an image or holding a videoconference with the patient except in the case of children in which case having an image would allow surgical closure to be planned without disturbing the dressings beforehand. However digital photographs can be taken and stored on ‘Photoweb’ within the Trust in this situation. Occasionally images of intra-oral lacerations might assist management decisions but getting good images is extremely difficult.<br /> <br /> 2.Ophthalmology<br /> Most patients attending HGH ED have had trauma to the front of the eye. There is a slit lamp on site and 3 ophthalmology clinics at the HGH during the week. Most patients are sorted out on site and followed up within 48 hrs in clinic if necessary. The few cases which need transfer are discussed on the phone and the clinical opinion was that neither a direct detailed history from the patient (via a video conference) nor video or still images would help in management decisions.<br /> <br /> 3.ENT<br /> Most transfers were because of persistent epistaxis. There appears to be no advantage to videoconferencing or further images sent from HGH in these circumstances. Occasionally patients present at HGH ED with compromised airways. These are best managed by the trained senior ED staff immediately at hand on site and rarely need immediate support from ENT specialists in Oxford although they may be transferred to their care subsequently. Again there seems no advantage to videoconferencing in these circumstances.<br /> <br /> 4.Paediatrics<br /> Transfers were for a wide variety of problems, usually because the child required sedation and intubation. There was no obvious advantage&nbsp; to videoconferencing in these cases.<br /> <br /> We also discussed with the HGH stroke physicians and cardiologists whether the management of&nbsp; patients they admitted to HGH could be improved by videoconferencing from the ED. There are clear ambulance protocols for stroke and chest pain which lead to most patients with a short history of stroke or myocardial infarction being taken straight to Oxford for emergency intervention. There are clear protocols for managing patients who are seen in HGH ED. Very occasionally there will be an unusual presentation of stroke but this can usually be managed with phone advice from Oxford.&nbsp;<br /> <br /> Logistical problems&nbsp;&nbsp;<br /> Communication of clinical information needs to be secure and confidential. There is broadband communication between HGH and Oxford based hospitals which can be used for video conferencing. At present we do not have the ability to extend this to clinicians outside the hospital (ie at home). If we implemented video conferencing with a specialist team in Oxford where the senior team members go home at night, it is only likely to be effective (i.e. involve a senior experienced member of the team) during the day (possibly 0800-2200hr).<br /> We analysed all 413 transfers to Oxford over 6 months. Only 46% (193) had a condition where video-conferencing or photography might have helped management. 136 of these patients were seen between 0800 and 2200hr and could potentially have benefited. This is equivalent to only 5 patients per week across the range of specialities cited previously. There are approximately 12 middle grade doctors&nbsp; employed in HGH ED between 0800 and 2200hr per week so over the course of 6 months each doctor would see 13 patients (1 every other week) in whom video conferencing/imaging might support specialist advice from Oxford. It seems unlikely that they would think to use it with so few cases per doctor. The specialist team in Oxford could ask for video conferencing but again it would be only an occasional use for each individual within the specialist team. Unless an intervention is used on a regular basis by the individuals involved, with some tangible benefit to its use, it seems unlikely that it would be used at all.&nbsp;<br /> There is also a concern over retention of video conferencing devices. It would be very easy for individuals to walk out of the department with a tablet device, iPad or iPod and it seems likely that they would need to be replaced on a regular basis.<br /> <br /> Expected Impact&nbsp;<br /> This study has shown that, in a well run DGH ED with regular links to a tertiary centre, the common presentations which require specialist advice can be managed with the use of protocols, supplemented by radiology image transmission (PACS) and that, contrary to expectation, a specialist history and /or patient imaging is rarely critical in deciding on management. Redesigning patient pathways from home so that the ambulance goes direct to a major centre with certain categories of patients, has also had a major impact in delivering the patient to the appropriate place for assessment and treatment.<br /> <br /> Conclusions<br /> We have collected detailed information on the patients transferred from a DGH ED to a specialist centre and admitted locally over 6 months. We have used that data to explore the potential use of videoconferencing with the specialists and local clinicians involved and shown that use of video-conferencing between patient and specialist is unlikely to be helpful when used for the common presentations in a DGH ED.<br /> <br /> <b>Patient and public involvement</b><br /> There was no patient or public involvement in the study as the planned involvement would have been in the second part of the study.<br /> <br /> <b>Data sharing statement</b><br /> See link <a href="https://www.nihr.ac.uk/documents/nihr-position-on-the-sharing-of-research-data/12253">[https://www.nihr.ac.uk/documents/nihr-position-on-the-sharing-of-research-data/12253</a>] for the NIHR position of the sharing of research data.&nbsp; The NIHR strongly supports the sharing of data in the most appropriate way, to help deliver research that maximises benefits to patients and the wider public, the health and care system and which contributes to economic growth in the UK.&nbsp; All requests for data should be directed to the award holder and managed by the award holder.<br /> <br /> <b>Disclaimer</b><br /> This project is funded by the National Institute for Health Research (NIHR) under its Research for Patient Benefit (RfPB) Programme (Grant Reference Number PB-PG-0909-20226). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.<br /> This project was carried out between October 2011 and December 2012. This final report has not been peer-reviewed. The report was examined by the Programme Director at the time of submission to assess completeness against the stated aims.

<b>PB-PG-0214-3310 – NIHR Research for Patient Benefit Programme – Final report</b><br /> <br /> <b>Project title:</b> The role of apixaban, aspirin and enoxaparin as thromboprophylaxis in patients newly diagnosed with multiple myeloma - an open label randomised feasibility study<br /> <br /> <b>Authors:</b><br /> Professor Roopen Arya - King’s College Hospital<br /> Dr Zara Sayar - King’s College Hospital<br /> Dr Jignesh Patel - King’s College London<br /> Professor John Weinman - King’s College London<br /> Dr Lara Roberts - King’s College Hospital<br /> Dr Julia Czuprynska - King’s College Hospital<br /> Dr Victoria Cornelius - Imperial College London<br /> Mr Eric Petts - Patient advisor<br /> <br /> <b>Plain language summary</b><br /> <br /> Background and Aim&nbsp;<br /> <br /> In recent years, a new anti-clot medicine has become available for use in clinical practice called apixaban. Clinical trials have shown that apixaban is as safe and effective as low molecular weight heparin (LMWH) - an injection based anti-clot medicine, in preventing blood clots for patients undergoing planned bone surgery. Apixaban is available as tablets and provides a solution to overcoming the shortcomings of current preventative therapy available. Very little work has been done to evaluate whether it would be appropriate to use apixaban in myeloma patients who are at risk of developing blood clots. The aim of our study was to assess the feasibility of undertaking a large clinical trial, testing current preventative therapies against apixaban. In addition, we wanted to explore what were patients’ understanding and experiences of the current and new preventative agents available.&nbsp;<br /> <br /> Method&nbsp;<br /> <br /> We conducted a small feasibility clinical trial, where patients either received aspirin or LMWH - current gold standard or the new apixaban therapy. In addition, two focus groups were conducted, one comprising of 'general' cancer patients, exploring their understanding of clots in the legs and the lungs and their views on the trial being proposed. The second focus group comprised patients who actually took part in the small trial we conducted and explored their views and experiences of being in the TiMM trial.&nbsp;<br /> <br /> Results&nbsp;<br /> <br /> Ten patients were recruited to the trial and followed up. Patients who were given apixaban did no worse than those patients who received current standard treatments - suggesting it would be reasonable to test apixaban in the myeloma population in a large clinical trial setting. Key messages which emerged from both focus groups were, when initially diagnosed with cancer, the cancer diagnosis is at the forefront of patients minds. Any thoughts on the risk of blood clots are secondary. Those patients who took part in the clinical trial, reported a very positive experience.&nbsp;<br /> <br /> Conclusions<br /> <br /> Our feasibility study results suggest that it could be possible to undertake a large mutli-centre clinical trial testing current gold standard treatment with the new medicine - apixaban, however there is insufficient data to confirm whether the design of our study is the most optimal for such a study<br /> <br /> <b>Keywords</b><br /> <br /> myeloma, thromboprophylaxis, venous thromboembolism, anticoagulants, low molecular weight heparin, aspirin, apixaban, direct oral anticoagulants<br /> <br /> <b>Summary of research findings</b><br /> <br /> Background&nbsp;<br /> <br /> Patients with cancer are at high risk of venous thromboembolism (VTE). Active malignancy is associated with an approximate 7 fold increase in VTE, with the incidence in some haematological cancers reported to be as high as 28 fold. Multiple myeloma is a malignant neoplasm of plasma cells that accumulate in the bone marrow leading to bone destruction and marrow failure.&nbsp;<br /> <br /> Myeloma is well linked with VTE. A study from the US found an incidence of deep vein thrombosis of 8.7/1000 in patients with myeloma, 3.1/1000 in patients with MGUS, compared to 0.9/1000 in those patients without plasma cell disorders. Recognised risk factors for VTE in this cohort include active disease, cancer chemotherapy, infection, previous VTE, immobility and paraplegia. Thalidomide and lenalidomide have been demonstrated to specifically increase the VTE risk. Neither drug used as mono-therapy significantly increases risk, but when combined with high-dose steroids or cytotoxic agents, the risk of VTE increases significantly. The VTE risk with lenalidomide alone appears to be lower than with thalidomide and the risk of VTE appears to be higher in patients with newly diagnosed myeloma treated with lenalidomide and dexamethasone. In the UK-based Myeloma XI trial, which reflects current treatment practice, the incidence of thrombosis was high (11.8%).&nbsp;<br /> <br /> The current British Society of Haematology (BSH) guidelines for myeloma suggest a risk assessment model for the prevention of VTE in myeloma patients treated with thalidomide or lenalidomide. The exact duration of thromboprophylaxis remains unclear but should be guided by risk factors such as active disease (e.g. for the first 4-6 months until disease control achieved) and de-escalated or discontinued unless there are ongoing significant risk factors. The BSH guidelines also stipulate that myeloma patients not receiving thalidomide or lenalidomide may also be considered at risk and thromboprophylaxis may be appropriate and should be considered on a case by case basis.&nbsp;<br /> <br /> Thromboprophylactic strategies. In the myeloma population, a number of different VTE thromboprophylactic strategies have been utilised in patients depending on risk; aspirin, LMWH or warfarin (fixed low dose or adjusted dose to achieve an INR of 2–3). The International Myeloma Working Group have also published recommendations pertaining to VTE prophylaxis for myeloma patients. Their recommendations incorporate both patient related and treatment-related risk factors for VTE and mirror the BSH guidelines. The majority of VTE in myeloma patients occur within the first 6 months of treatment, thus thromboprophylaxis is usually prescribed for at least the first 4–6 months of treatment until disease control is achieved, and may then be de-escalated or discontinued thereafter. In recent years, the availability of the direct oral anticoagulants (DOACs), e.g. apixaban, provide the potential to overcome the shortcomings of current preventative treatment, but to date have not been formally tested for their safety and effectiveness in this setting.&nbsp;<br /> <br /> Aims and Objectives&nbsp;<br /> <br /> To evaluate the feasibility of undertaking a multi-centre clinical trial assessing thromboprophylaxis with apixaban 2.5mg bd versus aspirin (in standard risk) or enoxaparin (in high risk) in newly diagnosed myeloma patients.&nbsp;<br /> To explore patients' views on participating in the feasibility clinical trial and their views and understanding of VTE and thromboprophylaxis.&nbsp;<br /> <br /> Methods&nbsp;<br /> <br /> 2 sub-studies were undertaken. The first was the feasibility clinical trial itself and the second, a qualitative sub-study evaluating patients' views on thromboprophylaxis and their experiences of participating in the clinical trial.&nbsp;<br /> <br /> Sub-study I - TiMM (Thromboprophylaxis in Multiple Myeloma)&nbsp;<br /> <br /> This open-label feasibility clinical trial recruited newly diagnosed myeloma patients and randomised the patients to either aspirin 75mg od or apixaban 2.5mg bd (if standard risk of VTE), or enoxaparin 40mg od or apixaban 2.5mg bd (if high risk of VTE). Patients were followed-up for a maximum of 6 months or until in remission. The primary objective of the trial was safety of apixaban in this specific population. The secondary objectives were the recruitment rate from the eligible population to the trial and the VTE event rate on the different modes of thromboproprophylaxis. Trial participants were followed up at the same time as their standard follow-up in the myeloma clinic, for a review of their thromboprophylaxis treatment. Adverse events in relation to the thromboprophylaxis were formally recorded and adjudicated.&nbsp;<br /> <br /> Sub-study II - focus groups&nbsp;<br /> <br /> This sub-study involved the completion of 2 focus groups; (i) one focused on the general perceptions of VTE amongst the general cancer population. This population was recruited from the Guy's Cancer patients panel, and involved exploring patients' views on thromboprophylaxis, their experience of thromboprophylaxis (if any), and what their views were on the proposed feasibility clinical trial. (ii) The second focus group comprised patients who actually took part in the feasibility clinical trial, and explored their views and experiences on taking part and the plans for the next stage of work. Both groups were facilitated by an experienced researcher. The facilitator followed a prespecified topic guide and were recorded. The recordings were transcribed and then thematic analysis was conducted on NVivo version12.&nbsp;<br /> Regulatory (MHRA) and ethical approvals were sought and approved from both sub-studies.&nbsp;<br /> <br /> Key findings<br /> <br /> TiMM Clinical Trial<br /> <br /> During the recruitment period (12th April 2016-21st April 2017), 32 patients were assessed for eligibility for recruitment to the trial. Twenty-one patients did not meet the eligibility criteria for the study, with 11 not eligible, as they were already prescribed an anticoagulant (8 patients) or antiplatelet (3 patients). Therefore 11 patients met the inclusion criteria and approached to enter the trial with 10 (91%) consenting to take part, suggesting that the design of the study would be acceptable to patients if conducted on a larger scale. The one patient who did not consent gave as a reason an aversion to clinical trials and indeed did not take part in the concurrent Myeloma clinical trial either.&nbsp;<br /> <br /> The target for recruitment to TiMM was 40 patients, however, this target was not reached, as the concurrent Myeloma clinical trial in place - the Cardamon Trial, withdrew authorisation of concurrent supportive trial participation (like TiMM) if patients were enrolled in Cardamon. This led to recruitment problems and demonstrates that if a supportive clinical trial were to be done in a larger scale, it needs to be integrated into the primary concurrent Myeloma trial that is running and needs to be designed to account for this.&nbsp;<br /> <br /> Of the 10 patients who took part in TiMM, 2 were classed as high risk of VTE, and were randomised to apixaban 2.5mg bd (no patients in TiMM were randomised to enoxaparin). Of these 2 patients, one patient was withdrawn after the baseline visit due to suffering a STEMI. The other patient completed the trial and ceased apixaban after completing their chemotherapy. Eight patients were classified as standard risk and randomised to aspirin or apixaban. Three patients in the apixaban group and 1 patient in the aspirin group completed their thromboprophylaxis. The other patients were withdrawn from the trial for the following reasons; 1 cephalic vein thrombosis in apixaban arm, 1 cephalic vein thrombosis in aspirin arm, 1 rectal bleed, 1 development of atrial fibrillation and 1 disease progression in the aspirin arm. No patients in TiMM suffered a VTE event or a major bleeding event.&nbsp;<br /> <br /> Focus Groups&nbsp;<br /> <br /> The focus group work suggested patients (n=4) newly diagnosed with cancer did not have VTE at the forefront of their minds and were more concerned with their active cancer. Feedback from the patients and carers (n=3) who took part in TiMM suggests that the design of TiMM was acceptable to them and they would take part in a similar study, if invited to do so.&nbsp;<br /> <br /> Expected impact<br /> <br /> The TiMM study suggests that there could be a role for direct oral anticoagulants as a thromboprophylaxis modality in newly diagnosed Myeloma and this should be tested formally in a clinical trial setting, as these agents offer significant practical advantages from a patient and clinician perspective. Key challenges / barriers for undertaking a multi-centre trial, which have been identified through TiMM are:&nbsp;<br /> <br /> (i) As newly diagnosed myeloma patients are treated, their clinical course is varied (due to comorbidities) and can become complicated, e.g. the development of thrombocytopenia, sepsis, renal failure or bleeding, all of which become barriers to continuing prophylaxis therapy&nbsp;<br /> (ii) There are a number of new therapies emerging in the myeloma field, with uncertain adverse effect profiles, e.g. carfilzomib&nbsp;<br /> (iii) Line-related thrombosis is not preventable with anticoagulation (already known - seen in 2 patients enrolled to TiMM)&nbsp;<br /> (iv) A lot of uncertainty remains around VTE risk assessment in clinical practice in the myeloma population and the interpretation of international guidelines with respect to this by clinicians.&nbsp;<br /> <br /> Conclusion<br /> <br /> Our feasibility clinical trial suggests that it is possible to recruit patients in the myeloma setting to a thrombophylaxis clinical trial, however there is insufficient data to be able to conclude that the trial design we used in TiMM is the optimal design for such a study. Patients who took part in TiMM reported a positive experience and stated that they would take part in a similar study, if invited to do so. Any future multi-centre thromboprophylaxis (supportive) clinical trial in this field should be incorporated into the concurrent national Myeloma trials being conducted at the time, so that co-recruitment is possible.<br /> <br /> <b>Patient and public involvement</b><br /> <br /> We had a Myeloma patient on the research team. His contribution to the study was extremely useful, as he provided us with comments on the initial design of our study and then on our patient information leaflets and his views and opinions on the various blood tests we planned to do, and what was and was not acceptable. We also had access to the Guy's cancer panel, which comprised patients with cancer who had an interest in helping with research studies - particularly from a PPI perspective.<br /> <br /> <b>Data sharing statement</b><br /> See link <a href="https://www.nihr.ac.uk/documents/nihr-position-on-the-sharing-of-research-data/12253">[https://www.nihr.ac.uk/documents/nihr-position-on-the-sharing-of-research-data/12253</a>] for the NIHR position of the sharing of research data.&nbsp; The NIHR strongly supports the sharing of data in the most appropriate way, to help deliver research that maximises benefits to patients and the wider public, the health and care system and which contributes to economic growth in the UK.&nbsp; All requests for data should be directed to the award holder and managed by the award holder.<br /> <br /> <b>Disclaimer</b><br /> This project is funded by the National Institute for Health Research (NIHR) under its Research for Patient Benefit (RfPB) Programme (Grant Reference Number PG-PB-0214-3310). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.<br /> <br /> This project was carried out between October 2015 and September 2017. This final report has not been peer-reviewed. The report was examined by the Programme Director at the time of submission to assess completeness against the stated aims.

Determination of the ideal medication characteristics for the safe and effective administration of medications via enteral feeding tubes

A novel neurofeedback based intervention to reduce neglect and improve function in stroke patients